CN104349726B - Tissue thickness compensator and manufacturing method thereof - Google Patents

Abstract

A tissue thickness compensator (33420) includes a membrane body (33426) formed from a continuously extruded shape and a fibrous drug core (33425).

Description

Tissue thickness compensator and manufacturing method thereof

Background technique

The present invention relates to a surgical instrument, and in various embodiments, the present invention relates to a surgical cutting and stapling instrument and a staple cartridge thereof designed for cutting and stapling tissue.

Contents of the invention

The following is a non-exhaustive list of embodiments of the invention that are claimed or may be claimable.

1. A method of manufacturing a tissue thickness compensator, the method comprising:

extruding a tube comprising a bore comprising a first open end and a second open end;

preparing strands of fibrous material comprising pharmaceutical properties;

positioning the strand relative to the first open end of the aperture;

inserting a grasper into the hole through the second open end;

grasping the strand with the grasper;

pulling the strand through the hole;

releasing said strand; and

The grasper is removed from the aperture through the second open end.

2. The method of embodiment 1, further comprising flattening the tube.

3. The method of example 2, comprising flattening the tube after the strand is drawn through the hole.

4. The method of any one of the preceding embodiments, further comprising splitting the tube and the strand after the strand is drawn through the aperture.

5. The method of any one of the preceding embodiments, further comprising fluffing the strands.

6. The method of example 5, comprising fluffing the strand during pulling the strand through the hole.

7. The method of any one of the preceding embodiments, further comprising making an incision in the strand.

8. The method of any one of the preceding embodiments, further comprising closing the first open end and closing the second open end.

9. A tissue thickness compensator manufactured by the method of any preceding embodiment.

10. A compensator attachable to an anvil of a fastening instrument, wherein the anvil comprises a forming surface, and wherein the compensator comprises:

a tube comprising a bore, a first end and a second end;

yarn strands positioned within the holes; and

An attachment portion is attachable to the anvil.

11. The compensator of embodiment 10, wherein the yarn strands are comprised of oxidized regenerated cellulose.

12. The compensator of embodiment 10 or embodiment 11, wherein the tube is constructed of a polymeric material.

13. The compensator according to any one of embodiments 10-12, wherein the first end and the second end have been sealed closed.

14. The compensator according to any one of embodiments 10-13, wherein the attachment portion comprises a first side wing configured to engage a first side of the anvil and a second side configured to engage the anvil the second flank.

15. The compensator according to any one of embodiments 10-14, wherein the tube comprises a flex joint.

16. A method of manufacturing a tissue thickness compensator, the method comprising:

Provide material layers;

positioning a fibrous hemostat material on the layer of material; and

The layer of material is folded around the fibrous hemostatic material.

17. The method of embodiment 16, further comprising flattening the layer of material and the fibrous hemostat material after folding the layer around the fibrous hemostat material.

18. The method of embodiment 16 or embodiment 17, further comprising sealing the layer of material around the fibrous hemostatic material.

19. The method of any one of embodiments 16-18, further comprising dividing the layer of material and the fibrous hemostatic material after folding the layer around the fibrous hemostatic material.

20. A tissue thickness compensator manufactured by the method of any one of embodiments 16-19.

21. A tissue thickness compensator comprising:

a film body formed from a continuous extruded shape; and

Fiber drug core.

Description of drawings

By referring to the following description of the embodiments of the present invention in conjunction with the accompanying drawings, the features and advantages of the present invention and methods of obtaining them will become more apparent, and the invention itself can be better understood, wherein:

Figure 1 is a cross-sectional view of a surgical instrument embodiment;

Figure 1A is a perspective view of one embodiment of an implantable staple cartridge;

1B-1E illustrate portions of an end effector for clamping and stapling tissue with an implantable staple cartridge;

2 is a partial cross-sectional side view of another end effector coupled to a portion of a surgical instrument, wherein the end effector supports a surgical staple cartridge and its anvil is in an open position;

3 is another partial cross-sectional side view of the end effector of FIG. 2 in a closed position;

4 is another partial cross-sectional side view of the end effector of FIGS. 2 and 3 as the knife bar begins to advance through the end effector;

5 is another partial cross-sectional side view of the end effector of FIGS. 2-4 with the knife bar partially advanced therethrough;

6A-6D depict deformation of surgical staples positioned within a collapsible staple cartridge body, according to at least one embodiment;

Figure 7A is a schematic diagram showing a staple positioned in a crushable staple cartridge body;

7B is a schematic diagram showing the crushable staple cartridge body of FIG. 7A being crushed by an anvil;

7C is a schematic diagram showing the crushable staple cartridge body of FIG. 7A being further crushed by the anvil;

7D is a schematic diagram showing the staple of FIG. 7A in a fully formed configuration and the crushable staple cartridge of FIG. 7A in a fully crushed condition;

8 is a top view of a staple cartridge including staples embedded in a collapsible staple cartridge body in accordance with at least one embodiment;

Figure 9 is a front view of the staple cartridge of Figure 8;

10 is an exploded perspective view of an alternative embodiment of a compressible staple cartridge including staples and a system for driving the staples against an anvil;

10A is a partial cross-sectional view of an alternative embodiment of the staple cartridge of FIG. 10;

Fig. 11 is a cross-sectional view of the staple cartridge of Fig. 10;

Figure 12 is a front view of a slide capable of traversing the staple cartridge of Figure 10 and moving the staples toward the anvil;

Figure 13 is a schematic illustration of a staple driver liftable toward the anvil by the slide of Figure 12;

14 is a perspective view of a staple cartridge including a rigid support portion and a compressible tissue thickness compensator for use with a surgical stapling instrument in accordance with at least one embodiment of the present invention;

Figure 15 is a partial exploded view of the staple cartridge of Figure 14;

Figure 16 is a fully exploded view of the staple cartridge of Figure 14;

17 is another exploded view of the staple cartridge of FIG. 14 without the wrap covering the tissue thickness compensator;

18 is a perspective view of the cartridge body or support portion of the staple cartridge of FIG. 14;

19 is a top perspective view of a sled movable within the staple cartridge of FIG. 14 to deploy staples from the staple cartridge;

Figure 20 is a bottom perspective view of the slider of Figure 19;

Figure 21 is a front view of the slider of Figure 19;

Figure 22 is a top perspective view of a driver capable of supporting one or more staples and being lifted upwardly by the slide of Figure 19 to eject the staples from the staple cartridge;

Figure 23 is a bottom perspective view of the driver of Figure 22;

24 is a wrap capable of at least partially surrounding a compressible tissue thickness compensator of a staple cartridge;

25 is a partial cross-sectional view of a staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing movement of the staples from an unfired position to a fired position during a first sequence;

Figure 26 is a front view of the staple cartridge of Figure 25;

Figure 27 is a detailed front view of the staple cartridge of Figure 25;

Figure 28 is a cross-sectional end view of the staple cartridge of Figure 25;

Figure 29 is a bottom view of the staple cartridge of Figure 25;

Figure 30 is a detailed bottom view of the staple cartridge of Figure 25;

31 is a longitudinal cross-sectional view of a staple cartridge including a rigid support portion and a compressible tissue thickness compensator, and an anvil in a closed position, showing movement of the staples from an unfired position to a fired position during a first sequence;

32 is another cross-sectional view of the anvil and staple cartridge of FIG. 31 showing the anvil in an open position after the firing sequence is complete;

33 is a partial detail view of the staple cartridge of FIG. 31 showing the staples in an unfired position;

34 is a cross-sectional front view of a staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing the staples in an unfired position;

Figure 35 is a detailed view of the staple cartridge of Figure 34;

36 is a front view of a staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing the staples in an unfired position, and an anvil in an open position;

37 is a front view of a staple cartridge and anvil in a closed position, the staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing the staples in an unfired position and captured on the anvil and tissue thickness organization between compensation pieces;

Figure 38 is a detailed view of the anvil and staple cartridge of Figure 37;

39 is a front view of a staple cartridge and an anvil in a closed position, the staple cartridge including a rigid support portion and a compressible tissue thickness compensator, showing the staples in an unfired position, shown positioned on the anvil and the thicker tissue between the staple cartridge;

Figure 40 is a detailed view of the anvil and staple cartridge of Figure 39;

41 is a front view of the anvil and staple cartridge of FIG. 39 showing tissue of varying thickness positioned between the anvil and the staple cartridge;

Figure 42 is a detailed view of the anvil block and the staple cartridge of Figure 39, as shown in Figure 41;

43 is a schematic diagram illustrating a tissue thickness compensator compensating for different tissue thicknesses captured within different staples;

44 is a schematic diagram illustrating the application of compressive pressure by a tissue thickness compensator to one or more blood vessels transected by a staple wire;

Figure 45 is a schematic diagram illustrating a situation where one or more staples are not properly formed;

46 is a schematic diagram showing a tissue thickness compensator that can compensate for improperly formed staples;

47 is a schematic diagram illustrating a tissue thickness compensator positioned in a region of tissue where multiple staple lines intersect;

Figure 48 is a schematic diagram showing tissue captured within a staple;

49 is a schematic diagram showing tissue and tissue thickness compensator captured within a staple;

Figure 50 is a schematic diagram showing tissue captured within a staple;

Figure 51 is a schematic diagram showing thick tissue and tissue thickness compensator captured within a staple;

52 is a schematic diagram showing thin tissue and tissue thickness compensator captured within a staple;

53 is a schematic diagram showing a tissue thickness compensator captured within a staple and tissue having an intermediate thickness;

54 is a schematic diagram showing a tissue thickness compensator captured within a staple and tissue having another intermediate thickness;

55 is a schematic diagram showing thick tissue and tissue thickness compensator captured within a staple;

56 is a partial cross-sectional view of an end effector of a surgical stapling instrument showing the firing bar and staple firing sled in a retracted, unfired position;

57 is another partial cross-sectional view of the end effector of FIG. 56 showing the firing rod and nail firing sled in a partially advanced position;

58 is a cross-sectional view of the end effector of FIG. 56 showing the firing rod in a fully advanced or fired position;

59 is a cross-sectional view of the end effector of FIG. 56 showing the firing rod in the retracted position after being fired and the nail firing sled remaining in its fully fired position;

Figure 60 is a detail view of the firing rod of Figure 59 in the retracted position;

61 is an exploded view of a retainer assembly including a retainer and two tissue thickness compensators, according to at least one embodiment;

Figure 62 is a perspective view of the retainer assembly shown in Figure 61;

Figure 63 is a perspective view of an anvil usable with the retainer assembly of Figure 61;

64 is a diagram showing the retainer assembly shown in FIG. 61 inserted into an end effector of a surgical stapler, the end effector comprising an anvil and a staple cartridge;

65 is a side view of the retainer assembly shown in FIG. 61 engaged with the staple cartridge of FIG. 64;

66 is a side view of the retainer assembly shown in FIG. 61 engaged with the staple cartridge and anvil of FIG. 64, showing the anvil in a closed position;

67 is a side view of the retainer assembly of FIG. 61 removed from the end effector of FIG. 64;

Figure 68 is a perspective view of a retainer;

69 is a side view of the retainer of FIG. 68 and a tissue thickness compensator attached to its bottom and top surfaces, showing the tissue thickness compensator engaged with a staple cartridge in a surgical stapler including an anvil. one of;

Figure 70 is a side view showing the anvil of Figure 69 in a closed position;

Figure 71 is an exploded perspective view of a retainer and tissue thickness compensator in accordance with at least one embodiment;

72 is an exploded perspective view of the tissue thickness compensator and anvil of the surgical stapler of FIG. 71;

Figure 73 is an exploded top perspective view of a retainer and tissue thickness compensator in accordance with at least one embodiment;

74 is an exploded bottom perspective view of the retainer and tissue thickness compensator of FIG. 73;

75 is a top perspective view of the retainer and tissue thickness compensator of FIG. 73 engaged with a surgical stapler;

76 is a bottom perspective view of the retainer and tissue thickness compensator of FIG. 73 engaged with the surgical stapler of FIG. 75;

77 is a side view of the retainer and tissue thickness compensator of FIG. 73 engaged with the surgical stapler of FIG. 75;

78 is a bottom perspective view of the retainer and tissue thickness compensator of FIG. 73, showing the tissue thickness compensator attached to the surgical stapler of FIG. 75;

79 is a top perspective view of the retainer and tissue thickness compensator of FIG. 73 showing the tissue thickness compensator attached to the anvil of FIG. 78;

80 is a side view of the tissue thickness compensator of FIG. 73 attached to the anvil of FIG. 78;

81 is a cross-sectional view of the retainer and tissue thickness compensator of FIGS. 73 and 74 attached to a staple cartridge and channel of a surgical stapler;

82 is a cross-sectional view of the retainer and tissue thickness compensator of FIGS. 73 and 74 attached to the staple cartridge and channel of the surgical stapler of FIG. 81 showing the anvil of the surgical stapler engaged with the tissue thickness compensator seat;

83 is a cross-sectional view of the tissue thickness compensator of FIG. 73 attached to an anvil of a surgical stapler and being moved away from a retainer;

84 is a cross-sectional view of a retainer assembly including a retainer, a tissue thickness compensator mounted on a first surface and a second surface of the retainer, and a hole connector;

85 is a perspective view of the retainer assembly of FIG. 84, showing a portion of the tissue thickness compensator removed for illustration purposes;

86 is a side view of the retainer assembly of FIG. 84 engaged with a surgical stapler including an anvil shown in an open position;

Figure 87 is a side view of the retainer assembly of Figure 84 and the anvil of Figure 86 shown in a closed position;

88 is a side view of the retainer assembly of FIG. 84, showing the retainer being removed from between the tissue thickness compensators of the retainer assembly;

89 is a side view of the retainer removed from the tissue thickness compensator of FIG. 84;

90 is a perspective view of a retainer configured to engage an anvil of a surgical stapler in accordance with at least one embodiment;

Figure 91 is a top view of the holder of Figure 90;

Figure 92 is a side view of the holder of Figure 90;

Figure 93 is a bottom view of the holder of Figure 90;

Figure 94 shows a retainer assembly comprising the retainer of Figure 90 and a tissue thickness compensator attached to a staple cartridge for a surgical stapler;

95 illustrates the retainer assembly and staple cartridge of FIG. 94 engaged with an anvil of an end effector of a surgical stapler;

96 illustrates the retainer assembly and staple cartridge of FIG. 94 engaged with the anvil of the end effector of the surgical stapler of FIG. 95;

Figure 97 shows the retainer assembly and staple cartridge of Figure 94 engaged on the anvil of the surgical stapler of Figure 95;

Figure 98 shows the retainer assembly and staple cartridge of Figure 94 engaged on the anvil of the surgical stapler of Figure 95 and the anvil being moved to a closed position;

Figure 99 shows the anvil of the surgical stapler of Figure 95 in an open position, the anvil having a tissue thickness compensator attached thereto and a retainer engaged with a cartridge channel of the surgical stapler;

Figure 100 shows the retainer of Figure 94 engaged with the staple cartridge channel of the surgical stapler of Figure 95 and the anvil in an open position;

101 is a cross-sectional view of a retainer including a tissue thickness compensator comprising protrusions or wings configured to engage an anvil of a surgical stapler;

102 is a cross-sectional view of a retainer including a tissue thickness compensator including a socket configured to engage an anvil of a surgical stapler;

Figure 103 is a perspective view of a holder comprising two plates connected by a hinge, according to at least one embodiment;

Figure 104 is a side view of the holder of Figure 103;

Figure 105 is a rear perspective view of an embodiment of an insertion tool that can be used with the holder of Figure 103;

Figure 106 is a top perspective view of the insertion tool of Figure 105;

107 is a rear perspective view of the insertion tool of FIG. 105 with a portion of the insertion tool removed for illustration purposes;

108 is a side view of the insertion tool of FIG. 105 with a portion of the insertion tool removed for illustration purposes;

Figure 109 is a top view of the insertion tool of Figure 105;

110 is a perspective view of a retainer assembly comprising the retainer of FIG. 103, a tissue thickness compensator positioned on the retainer, a staple cartridge positioned on the retainer, and the retainer of FIG. 105 engaged with the retainer. an insertion tool for which part of the insertion tool has been removed for illustration purposes;

111 is a side view of a retainer assembly comprising the retainer of FIG. 103, a tissue thickness compensator positioned on the retainer, and the insertion tool of FIG. 105 engaged with the retainer, wherein a portion of the insertion tool is inserted removed for illustration purposes;

Fig. 112 shows the retainer assembly of Fig. 110 inserted into a surgical instrument including an anvil and a staple cartridge channel, with a portion of the insertion tool removed for illustration purposes;

113 shows the retainer assembly of FIG. 110 inserted into a surgical instrument including an anvil and a staple cartridge channel, with a portion of the insertion tool removed for illustration purposes;

114 shows the insertion tool of FIG. 105 being moved relative to the retainer to engage the staple cartridge in the staple cartridge channel and engage the tissue thickness compensator with the anvil, with a portion of the insertion tool removed for illustration purposes ;

115 shows the insertion tool of FIG. 105 being moved relative to the retainer to disengage the retainer from the tissue thickness compensator and staple cartridge, with a portion of the insertion tool removed for illustration purposes;

116 is a cross-sectional view of a tissue thickness compensator attached to an anvil of a surgical stapling instrument in accordance with at least one embodiment;

117 is a schematic diagram illustrating a deformable staple at least partially capturing therein the tissue thickness compensator of FIG. 116;

118 is a cross-sectional view of an end effector of a surgical stapling instrument comprising a staple cartridge comprising a first tissue thickness compensator and an anvil comprising a second tissue thickness compensator in accordance with at least one embodiment ;

119 is a cross-sectional view of the end effector of FIG. 118 showing staples from the staple cartridge moved from an unfired position to a fired position;

120 is a perspective view of a tissue thickness compensator attached to an anvil of an end effector, wherein the tissue thickness compensator includes a plurality of bladders, according to at least one embodiment;

Figure 120A is a partial perspective view of the tissue thickness compensator of Figure 120;

121 is a cross-sectional view of a staple being moved from an unfired position to a fired position to pierce the capsule of the tissue thickness compensator of FIG. 120;

Figure 122 is an exploded view of an anvil and tissue thickness compensator in accordance with at least one embodiment;

123 is a cross-sectional view of an anvil comprising a plurality of staple forming pockets and a tissue thickness compensator comprising a plurality of pockets aligned with the forming pockets, according to at least one embodiment;

124 is a detail view of the bladder of the tissue thickness compensator of FIG. 123;

125 is a schematic diagram showing the anvil and tissue thickness compensator of FIG. 123 positioned relative to tissue to be stapled with staples from a staple cartridge positioned on the opposite side of the tissue;

126 is a schematic diagram showing the anvil of FIG. 123 being moved toward the staple cartridge of FIG. 125 and staples partially fired from the staple cartridge;

127 is a schematic diagram showing the staple of FIG. 126 in a fully fired configuration and the bladder of the tissue thickness compensator of FIG. 123 in a ruptured state;

Figure 128 is a schematic diagram showing the staple of Figure 126 in an unfired state;

129 is a schematic diagram showing the staple of FIG. 126 in a fully fired configuration and the tissue thickness compensator of FIG. 123 in an at least partially transected state;

Figure 130 is a cross-sectional perspective view of an alternative embodiment of a tissue thickness compensator in accordance with at least one embodiment;

131 is a perspective view of an alternative embodiment of a tissue thickness compensator comprising a plurality of bladders aligned with cutting members of a surgical stapling instrument;

Figure 132 is a detail view of the bladder of Figure 131;

133 is a cross-sectional view of the tissue thickness compensator of FIG. 131 comprising a plurality of pockets aligned with knife slots of an anvil of a surgical stapling instrument;

134 and 135 illustrate an alternative embodiment of a tissue thickness compensator being attached to an anvil;

Figure 136 is a cross-sectional exploded view of an anvil and compensator in accordance with at least one embodiment;

Figure 137 shows the compensator of Figure 136 attached to the anvil;

138 is a partial perspective view of a tissue thickness compensator and a cutting member that incises into the tissue thickness compensator in accordance with at least one embodiment;

Figure 139 is a partial cross-sectional view of an alternative embodiment of a tissue thickness compensator according to at least one embodiment;

Figure 140 is a partial cross-sectional view of another alternative embodiment of a tissue thickness compensator in accordance with at least one embodiment;

141 is a schematic diagram illustrating a tissue thickness compensator comprising a plurality of irregular and/or asymmetric cavities, according to various embodiments;

Figure 142 is a partial cross-sectional view of a tissue thickness compensator attached to an anvil of a surgical stapling instrument in accordance with at least one embodiment;

143 is a perspective view of a seamless extruded shell or outer tube of a tissue thickness compensator in accordance with at least one embodiment;

144 is a perspective view of another seamless extruded shell or outer tube of a tissue thickness compensator in accordance with at least one embodiment;

Figure 145 is a perspective view of oxidized regenerated cellulose fibers;

Figure 146 is a perspective view of an oxidized regenerated cellulose fiber shorter than the fiber of Figure 145;

Figure 147 is a schematic diagram showing the fibers of Figure 145 being woven into strands using the fibers of Figure 146;

Figure 148 shows the strand of Figure 147 being fluffed and at least partially cut;

Fig. 149 shows the grasper inserted through the housing or outer tube of the tissue thickness compensator and positioned to grasp the strands of Fig. 147;

Figure 150 shows the grasper of Figure 149 being withdrawn from the cannula and the strand of Figure 147 being pulled through the housing;

Figure 151 shows the shell and strands of Figure 150 being segmented;

Figure 152 shows the end of the housing being heat welded and/or sealed;

Figure 153 illustrates a method for producing a tissue thickness compensator without transverse seams;

Figure 154 shows an anvil of a surgical stapler and a plurality of compensators optionally attached to the anvil, wherein each of the compensators comprises an array of capillary channels;

Figure 155 is a plan view of a compensator attachable to an anvil;

Figure 156 is a detail view of a portion of the compensator of Figure 155;

Figure 157 is a perspective view of an end effector of a surgical stapling instrument;

Fig. 158 is another perspective view of the end effector of Fig. 157 showing fluid disposed on a tissue thickness compensator of the end effector;

Figure 159 is another perspective view of the end effector of Figure 159 showing the compensator attached to the anvil of the end effector;

Figure 160 is a detail view of an array of capillary channels on the compensator of Figure 159;

Figure 161 is an exploded view of a compensator comprising multiple layers, according to at least one embodiment;

Figure 162 is an exploded view of a compensator and anvil of a surgical stapling instrument in accordance with at least one embodiment;

Figure 163 is a partial cross-sectional view of the compensator and anvil of Figure 162;

Figure 164 is an exploded view of a compensator comprising a cellular ingrowth matrix, according to at least one embodiment;

Figure 165 is a perspective view of the compensator of Figure 164;

Figure 166 is a perspective view of a layer of fibrous material for a compensator;

Figure 167 is a perspective view of multiple fiber layers stacked on top of each other, according to at least one embodiment;

Figure 168 is a perspective view of another plurality of fiber layers stacked on top of each other in accordance with at least one embodiment;

Figure 169 is a perspective view of a layer of fibrous material for a compensator;

Figure 170 is a perspective view of multiple fiber layers stacked on top of each other, wherein the fibers are arranged in different directions, according to at least one embodiment;

Figure 171 is a perspective view of another plurality of fiber layers stacked on top of each other in accordance with at least one embodiment;

Figure 172 is a perspective view of an end effector insert and an end effector of a surgical instrument in accordance with at least one embodiment;

173 is an elevational view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;

174 is an elevational view of a tissue thickness compensator positioned in an end effector of a surgical instrument in accordance with at least one embodiment;

Figure 175 is a perspective view of a sleeve positioned on an anvil of an end effector of a surgical instrument in accordance with at least one embodiment;

Figure 176 is a plan view of a bifurcation of the sleeve of Figure 175;

Figure 177 is a front view of the bifurcated portion of the sleeve of Figure 175;

Figure 178 is an end view of the bifurcated portion of the sleeve of Figure 175;

Figure 179 is a perspective view of a bifurcation of the sleeve of Figure 175;

Figure 180 is a plan view of a tissue compensator of a cannula in accordance with at least one embodiment;

Figure 181 is a perspective view of the tissue compensator of Figure 180;

Figure 182 is a front view of the tissue compensator of Figure 180;

Figure 183 is a plan view of a tissue compensator of a cannula, according to at least one embodiment;

Figure 184 is a perspective view of the tissue compensator of Figure 183;

Figure 185 is a front view of the tissue compensator of Figure 183;

Figure 186 is a perspective view of the nose of the cannula of Figure 175;

Figure 187 is another perspective view of the nose of Figure 186;

Figure 188 is a plan view of the nose of Figure 186 showing the internal geometry in phantom;

Figure 189 is a front view of the nose of Figure 186 showing the internal geometry in phantom;

Figure 190 is another perspective view of the sleeve of Figure 175 positioned on an anvil;

Figure 191 is a plan view of the sleeve of Figure 175 positioned on an anvil;

Figure 192 is a front view of the sleeve of Figure 175 positioned on an anvil;

Figure 193 is a plan view of the sleeve of Figure 175 positioned on an anvil showing the translating firing rod shown in phantom;

Figure 194 is a front view of the sleeve of Figure 175 positioned on an anvil showing the translating firing rod shown in phantom;

Figure 195 is a plan view of the sleeve of Figure 175 positioned on an anvil showing the nose released from the sleeve;

Figure 196 is a front view of the sleeve of Figure 175 positioned on an anvil showing the nose released from the sleeve;

Figure 197 is a plan view of the sleeve of Figure 175 positioned on the anvil, showing the firing rod in phantom and showing the nose released from the sleeve;

Figure 198 is a front view of the sleeve of Figure 175 positioned on an anvil, showing the firing rod in phantom and showing the nose released from the sleeve;

Figure 199 is a partial perspective view of the sleeve, anvil, and firing rod of Figure 197;

Figure 200 is another partial perspective view of the sleeve, anvil, and firing rod of Figure 197;

Figure 201 is a front cross-sectional view of the sleeve and anvil of Figure 175;

Figure 202 is an elevational cross-sectional view of the anvil of Figure 175 showing the tissue compensator released from the cannula;

Figure 203 is a plan view of an end effector insert according to at least one embodiment;

Figure 204 is a front view of the end effector insert of Figure 203;

Figure 205 is a perspective view of the end effector insert of Figure 205;

Figure 206 is a partial perspective view of the end effector insert of Figure 203, showing the end effector insert engaging an anvil of an end effector of a surgical instrument;

207 is a partial perspective view of the end effector insert of FIG. 203, showing the end effector insert engaging a staple cartridge of the end effector of the surgical instrument;

Figure 208 is a front view of the end effector insert of Figure 203, showing the end effector insert engaging the end effector of a surgical instrument;

Figure 209 is a front view of the end effector insert of Figure 203 positioned in the end effector of a surgical instrument;

210 is a perspective view of a tissue thickness compensator positioned in an end effector showing a portion of the tissue thickness compensator cut away, according to at least one embodiment;

211 is a perspective view of the tissue thickness compensator of FIG. 210 secured to an anvil of an end effector by electrostatic charge;

212 is a perspective view of the tissue thickness compensator of FIG. 210 secured to an anvil of an end effector by a suction element;

213 is a perspective view of the tissue thickness compensator of FIG. 210 secured to an anvil of an end effector by hook-and-loop fasteners;

FIG. 214 is a partial perspective view of the tissue thickness compensator of FIG. 210 secured to the anvil of the end effector by the strap;

215 is a partial perspective view of the tissue thickness compensator of FIG. 210 secured to an anvil of an end effector by a socket at a distal end of the tissue thickness compensator;

216 is a partial perspective cross-sectional view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument in accordance with at least one embodiment;

Figure 217 is a front cross-sectional view of the tissue thickness compensator of Figure 216;

Figure 218 is another front cross-sectional view of the tissue thickness compensator of Figure 216;

219 is an elevational cross-sectional view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument showing the latch in a closed position in accordance with at least one embodiment;

Figure 220 is an elevational cross-sectional view of the tissue thickness compensator of Figure 219, showing the latch in an open position;

221 is an elevational cross-sectional view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument in accordance with at least one embodiment;

222 is an elevational cross-sectional view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument in accordance with at least one embodiment;

223 is an elevational cross-sectional view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument in accordance with at least one embodiment;

224 is an elevational cross-sectional view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument in accordance with at least one embodiment;

225 is a perspective cutaway exploded view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument in accordance with at least one embodiment;

Figure 226 is a perspective view of the tissue thickness compensator of Figure 225, showing the tissue thickness compensator moved toward the anvil;

Figure 227 is an elevational cross-sectional view of the tissue thickness compensator of Figure 225 engaged with an anvil;

228 is a perspective cross-sectional view of a tissue thickness compensator secured to an anvil of an end effector of a surgical instrument in accordance with at least one embodiment;

Figure 229 is a perspective cutaway exploded view of the tissue thickness compensator and anvil of Figure 228;

Figure 230 is a front view of a tissue thickness compensator according to at least one embodiment;

Figure 231 is a perspective view of the tissue thickness compensator of Figure 230;

Figure 232 is another perspective view of the tissue thickness compensator of Figure 230;

233 is a perspective view of the tissue thickness compensator of FIG. 230, showing the tissue thickness compensator moving toward the anvil of the end effector of the surgical instrument;

234 is a cross-sectional view of the tissue thickness compensator of FIG. 230 positioned on an anvil;

Figure 235 is a perspective view of the tissue thickness compensator of Figure 230 positioned on an anvil;

FIG. 236 is a perspective view of the tissue thickness compensator of FIG. 230 positioned on an anvil, showing cutting elements severing the tissue thickness compensator;

Figure 237 is a cross-sectional front view of an end effector of a surgical stapling instrument comprising an anvil and a charging layer in accordance with at least one embodiment;

Figure 238 is a bottom view of the anvil and charging layer of Figure 237;

Figure 239 is an exploded view of the anvil and charging layer of Figure 237 and a tissue thickness compensator releasably attached to the charging layer;

Figure 240 is a perspective view of a tissue thickness compensator according to at least one embodiment;

Figure 241 is a plan view of the tissue thickness compensator of Figure 240;

Figure 240A is a perspective view of a tissue thickness compensator according to at least one alternative embodiment;

Figure 241A is a plan view of the tissue thickness compensator of Figure 240A;

Figure 242 is a perspective view of a tissue thickness compensator according to at least one alternative embodiment;

Figure 243 is a plan view of the tissue thickness compensator of Figure 242;

Figure 244 is a perspective view of a tissue thickness compensator according to at least one embodiment;

Figure 245 is a perspective view of a tissue thickness compensator attached to an anvil, according to at least one embodiment;

Figure 246 is a cross-sectional view of the anvil and tissue thickness compensator of Figure 245;

Figure 247 is a cross-sectional view of the tissue thickness compensator of Figure 245;

Figure 248 is a perspective view of a tissue thickness compensator attached to an anvil according to at least one alternative embodiment;

Figure 249 is a cross-sectional view of the anvil and tissue thickness compensator of Figure 248;

Figure 250 is a cross-sectional view of the tissue thickness compensator of Figure 248 in an open configuration;

Figure 251 is a perspective view of a tissue thickness compensator attached to an anvil according to at least one alternative embodiment;

Figure 252 is a cross-sectional view of the anvil and tissue thickness compensator of Figure 251;

Figure 253 is a perspective view of a tissue thickness compensator attached to an anvil according to at least one alternative embodiment;

Figure 254 is a cross-sectional view of the anvil and tissue thickness compensator of Figure 253;

Figure 255 is a perspective view of a tissue thickness compensator attached to an anvil according to at least one alternative embodiment;

Figure 256 is a cross-sectional view of the anvil and tissue thickness compensator of Figure 255;

257 is a perspective view of a tissue thickness compensator attached to an anvil, according to at least one alternative embodiment; and

258 is a cross-sectional view of the anvil and tissue thickness compensator of FIG. 257.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate certain embodiments of the invention in one form, and such exemplifications should not be construed as limiting the scope of the invention in any way.

detailed description

The applicant of the present application also owns the following U.S. patent applications, each of which is fully incorporated herein by reference:

U.S. Patent Application Serial No. 12/894,311, entitled "SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS" (Attorney Docket No. END6734USNP/100058);

U.S. Patent Application Serial No. 12/894,340, entitled "SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS" (Attorney Docket No. END6735USNP/100059);

U.S. Patent Application Serial No. 12/894,327, entitled "JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS" (Attorney Docket No. END6736USNP/100060);

U.S. Patent Application Serial No. 12/894,351, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE ANDDISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS" (Attorney Docket No. END6839USNP/100524);

U.S. Patent Application Serial No. 12/894,338, entitled "IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFOR MARRANGEMENT" (Attorney Docket No. END6840USNP/100525);

U.S. Patent Application Serial No. 12/894,369, entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER" (Attorney Docket No. END6841USNP/100526);

U.S. Patent Application Serial No. 12/894,312, entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS" (Attorney Docket No. END6842USNP/100527);

U.S. Patent Application Serial No. 12/894,377, entitled "SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE" (Attorney Docket No. END6843USNP/100528);

U.S. Patent Application Serial No. 12/894,339, entitled "SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROLARRANGEMENT" (Attorney Docket No. END6847USNP/100532);

U.S. Patent Application Serial No. 12/894,360, entitled "SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM" (Attorney Docket No. END6848USNP/100533);

U.S. Patent Application Serial No. 12/894,322, entitled "SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLECARTRIDGE ARRANGEMENTS" (Attorney Docket No. END6849USNP/100534);

US PATENT APPLICATIONS 94,32/10, TITLE "SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES AND SURGICAL STAPLING INSTRUMENTS WITH SYSTEMS FOR PREVENTING ACTUATIONMOTIONS WHEN A CARTRIDGE IS NOT PRESENT" (Attorney Docket No. END6855USNP/100540);

U.S. Patent Application Serial No. 12/894,383, entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLELAYERS" (Attorney Docket No. END6856USNP/100541);

U.S. Patent Application Serial No. 12/894,389, entitled "COMPRESSIBLE FASTENER CARTRIDGE" (Attorney Docket No. END6857USNP/100542);

U.S. Patent Application Serial No. 12/894,345, entitled "FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT" (Attorney Docket No. END6858USNP/100543);

U.S. Patent Application Serial No. 12/894,306, entitled "COLLAPSIBLE FASTENER CARTRIDGE" (Attorney Docket No. END6859USNP/100544);

U.S. Patent Application Serial No. 12/894,318, entitled "FASTENER SYSTEM COMPRISING A PLURALITY OF CONNECTED RETENTIONMATRIX ELEMENTS" (Attorney Docket No. END6860USNP/100546);

U.S. Patent Application Serial No. 12/894,330, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENTMATRIX" (Attorney Docket No. END6861USNP/100547);

U.S. Patent Application Serial No. 12/894,361, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX" (Attorney Docket No. END6862USNP/100548);

U.S. Patent Application Serial No. 12/894,367, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX" (Attorney Docket No. END6863USNP/100549);

U.S. Patent Application Serial No. 12/894,388, entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER" (Attorney Docket No. END6864USNP/100550);

U.S. Patent Application Serial No. 12/894,376, entitled "FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES" (Attorney Docket No. END6865USNP/100551);

US Patent Application Serial No. 13/097,865, entitled "SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMINGPOCKETS" (Attorney Docket No. END6735USCIP1/100059CIP1);

U.S. Patent Application Serial No. 13/097,936, entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER" (Attorney Docket No. END6736USCIP1/100060CIP1);

U.S. Patent Application Serial No. 13/097,954, entitled "STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLE PORTION" (Attorney Docket No. END6840USCIP1/100525CIP1);

U.S. Patent Application Serial No. 13/097,856, entitled "STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN ACOMPRESSIBLE PORTTION THEREOF" (Attorney Docket No. END6841USCIP1/100526CIP1);

U.S. Patent Application Serial No. 13/097,928, entitled "TISSUE THICKNESS COMPENSATOR COMPRISING DETACHABLE PORTIONS" (Attorney Docket No. END6842USCIP1/100527CIP1);

U.S. Patent Application Serial No. 13/097,891 entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISINGAN ADJUSTABLE ANVIL" (Attorney Docket No. END6843USCIP1/100528CIP1);

US Patent Application Serial No. 13/097,948 entitled "STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION" (Attorney Docket No. END6847USCIP1/100532CIP1);

U.S. Patent Application Serial No. 13/097,907, entitled "COMPRESSIBLE STAPLE CARTRIDGE ASSEMBLY" (Attorney Docket No. END6848USCIP1/100533CIP1);

U.S. Patent Application Serial No. 13/097,861, entitled "TISSUE THICKNESS COMPENSATOR COMPRISING PORTTIONS HAVING DIFFERENT PROPERTIES" (Attorney Docket No. END6849USCIP1/100534CIP1);

U.S. Patent Application Serial No. 13/097,869, entitled "STAPLE CARTRIDGE LOADING ASSEMBLY" (Attorney Docket No. END6855USCIP1/100540CIP1);

U.S. Patent Application Serial No. 13/097,917, entitled "COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS" (Attorney Docket No. END6856USCIP1/100541CIP1);

U.S. Patent Application Serial No. 13/097,873, entitled "STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION" (Attorney Docket No. END6857USCIP1/100542CIP1);

U.S. Patent Application Serial No. 13/097,938, entitled "STAPLE CARTRIDGE COMPRISING COMPRESSIBLE DISTORTION RESISTANT COMPONENTS" (Attorney Docket No. END6858USCIP1/100543CIP1);

US Patent Application Serial No. 13/097,924 entitled "STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END6859USCIP1/100544CIP1);

US Patent Application Serial No. 13/242,029 entitled "SURGICAL STAPLER WITH FLOATING ANVIL" (Attorney Docket No. END6841USCIP2/100526CIP2);

U.S. Patent Application Serial No. 13/242,066, entitled "CURVED END EFFECTOR FOR A STAPLING INSTRUMENT" (Attorney Docket No. END6841USCIP3/100526CIP3);

U.S. Patent Application Serial No. 13/242,086, entitled "STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK" (Attorney Docket No. END7020USNP/110374);

U.S. Patent Application Serial No. 13/241,912, entitled "STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT" (Attorney Docket No. END7019USNP/110375);

U.S. Patent Application Serial No. 13/241,922 entitled "SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS" (Attorney Docket No. END7013USNP/110377);

U.S. Patent Application Serial No. 13/241,637, entitled "SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTUATION MOTIONS" (Attorney Docket No. END6888USNP3/110378); and

US Patent Application Serial No. 13/241,629, entitled "SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE ENDEFFECTOR" (Attorney Docket No. END6888USNP2/110379).

The applicant of the present application also owns the following U.S. patent applications, which were filed on the same date as the present application, and each of which is hereby incorporated by reference in its entirety:

US Patent Application Serial No. _______________ entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFCAPSULES" (Attorney Docket No. END6864USCIP1/100550CIP1);

US Patent Application Serial No. _______________ entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS" (Attorney Docket No. END6864USCIP2/100550CIP2);

US Patent Application Serial No. _______________ entitled "EXPANDABLE TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END6843USCIP2/100528CIP2).

US Patent Application Serial No. _______________ entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR" (Attorney Docket No. END6843USCIP3/100528CIP3);

US Patent Application Serial No. _______________ entitled "RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END6843USCIP4/100528CIP4);

US Patent Application Serial No. _______________ entitled "TISSUE THICKNESS COMPENSATOR COMPRISING AT LEAST ONEMEDICAMENT" (Attorney Docket No. END6843USCIP5/100528CIP5);

US Patent Application Serial No. _______________ entitled "TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE ANDEXPANSION" (Attorney Docket No. END6843USCIP6/100528CIP6);

US Patent Application Serial No. _______________ entitled "TISSUE TISSUE THICKNESS COMPENSATOR COMPRISING FIBERS TO PRODUCE A RESILIENT LOAD" (Attorney Docket No. END6843USCIP7/100528CIP7);

US Patent Application Serial No. _______________ entitled "TISSUE TISSUE THICKNESS COMPENSATOR COMPRISING STRUCTURE TO PRODUCE A RESILIENT LOAD" (Attorney Docket No. END6843USCIP8/100528CIP8);

US Patent Application Serial No. _______________ entitled "TISSUE TISSUE THICKNESS COMPENSATOR COMPRISING RESILIENTMEMBERS" (Attorney Docket No. END6843USCIP9/100528CIP9);

U.S. Patent Application Serial No. _______________ entitled "METHODS FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTSFOR SURGICAL STAPLERS" (Attorney Docket No. END6843USCIP10/100528CP10);

US Patent Application Serial No. _______________, entitled "TISSUE THICKNESS COMPENSATORS" (Attorney Docket No. END6843USCIP11/100528CP11);

US Patent Application Serial No. _______________ entitled "LAYERED TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END6843USCIP12/100528CP12);

US Patent Application Serial No. _______________ entitled "TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS" (Attorney Docket No. END6843USCIP13/100528CP13);

US Patent Application Serial No. _______________ entitled "TISSUE TISSUE THICKNESS COMPENSATOR COMPRISING CAPSULESDEFINING A LOW PRESSURE ENVIRONMENT" (Attorney Docket No. END7100USNP/110601);

U.S. Patent Application Serial No. _______________, entitled "TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OFMATERIALS" (Attorney Docket No. END7101USNP/110602);

US Patent Application Serial No. _______________ entitled "MOVABLE MEMBER FOR USE WITH A TISSUE THICKNESS COMPENSATOR" (Attorney Docket No. END7107USNP/110603);

US Patent Application Serial No. _______________, entitled "TISSUE TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OFMEDICAMENTS" (Attorney Docket No. END7102USNP/110604);

U.S. Patent Application Serial No. _______________, entitled "TISSUE TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS" (Attorney Docket No. END7104USNP/110606);

U.S. Patent Application Serial No. _______________, entitled "TISSUE TISSUE THICKNESS COMPENSATOR COMPRISING TISSUE INGROWTHFEATURES" (Attorney Docket No. END7105USNP/110607); and

US Patent Application Serial No. _______________, entitled "DEVICES AND METHODS FOR ATTACHING TISSUE THICKNESSCOMPENSATING MATERIALS TO SURGICAL STAPLING INSTRUMENTS" (Attorney Docket No. END7106USNP/110608).

Certain exemplary embodiments will now be described to provide an overall understanding of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art should understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. Structures shown or described in connection with one exemplary embodiment may be combined with structures of other embodiments. Such modifications and variations are included within the scope of the present invention.

Any of the methods disclosed or claimed herein for making, forming or otherwise preparing an article or product may be used to make, form or otherwise prepare all of the contemplated articles or products or part thereof, and where such methods are used to manufacture, form or otherwise prepare part of the article or product under consideration, the remainder of the article or product may be transformed in any way (including using the any of the other methods for making, forming or otherwise preparing an article or product protected by this book), and the parts so prepared may be combined in any way. Similarly, any article or product disclosed or claimed herein may exist alone or in combination with any other article or product of the present disclosure with which it is compatible, or as an inventive disclosure with which it is compatible. an integral part of any other article or product. Thus, a particular feature, structure, or characteristic shown or described in connection with one article, product, or method may be completely or partially (without limitation) compatible with one or more features, structures, or structures of another compatible article, product, or method. , or features are combined. Such modifications and variations are included within the scope of the present invention.

Where particular embodiments of the invention are disclosed herein by reference to particular drawings or otherwise, or that particular manufactures, products or methods may include particular structures, characteristics, or characteristics, the reader should understand that this means that those structures, characteristics, or Features may be implemented in any suitable combination in the article, product or method under consideration. In particular, such disclosure of multiple optional structures, properties, or characteristics should be understood as disclosing all combinations of such structures, properties, or features, with the exception that structures, properties, or features are disclosed as alternatives to each other. or features. Where such structures, properties, or characteristics are disclosed as alternatives to each other, this is to be understood as disclosing these alternatives as alternatives to each other.

The terms "proximal" and "distal" are used herein with respect to a clinician manipulating the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion remote from the clinician. It should also be understood that spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein in connection with the drawings for the sake of brevity and clarity. However, surgical instruments are used in many orientations and positions, and these terms are not limiting and/or absolute.

Various exemplary devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, the reader will readily appreciate that the various methods and devices disclosed herein can be used in a variety of surgical procedures and applications, including in conjunction with open surgery. Continuing to read the detailed description, readers will further understand that the various devices disclosed herein can be inserted into the body in any way, such as through natural orifices, through incisions or puncture holes formed in tissues, and the like. The working or end effector portion of the instrument can be inserted directly into the patient or through an access device having a working channel through which the end effector and elongated shaft of the surgical instrument can be advanced.

Turning to the drawings, wherein like numerals represent like components throughout the several views, FIG. 1 illustrates a surgical instrument 10 that enables several unique benefits to be practiced. Surgical stapling instrument 10 is designed to manipulate and/or actuate various forms and sizes of end effectors 12 to which it is operatively attached. In FIGS. 1-1E , for example, the end effector 12 includes an elongated channel 14 forming a lower jaw 13 of the end effector 12 . The elongated channel 14 is capable of supporting an “implantable” staple cartridge 30 and also movably supporting an anvil 20 serving as the upper jaw 15 of the end effector 12 .

The elongated channel 14 may be fabricated from, for example, 300 & 400 series, 17-4 & 17-7 stainless steel, titanium, etc., and may be formed with spaced apart side walls 16 . The anvil 20 may be made of, for example, 300 & 400 series, 17-4 & 17-7 stainless steel, titanium, etc., and may have a staple forming lower surface (generally designated 22) having a plurality of staple forming recesses formed therein Pit 23. See Figures 1B-1E. Additionally, the anvil 20 has a bifurcated slide assembly 24 protruding proximally therefrom. Anvil pins 26 protrude from each side of the slideway assembly 24 to be received within corresponding slots or openings 18 in the side walls 16 of the elongated channel 14 to facilitate moving or pivoting the anvil pins. Attaches to the corresponding slot or opening.

Various forms of implantable staple cartridges can be used with the surgical instruments disclosed herein. Specific staple cartridge configurations and configurations are discussed in more detail below. In FIG. 1A , however, an implantable staple cartridge 30 is shown. Staple cartridge 30 has a body portion 31 constructed of a compressible hemostatic material, such as oxidized regenerated cellulose ("ORC") or bioabsorbable foam, in which rows of unformed metal staples 32 are supported. To prevent the staples from being affected and to prevent the hemostat material from being activated during the introduction and positioning process, the entire cartridge can be coated or wrapped with a biodegradable film 38, such as under the trademark Films of hexacyclone or polyglyceryl sebacate (PGS) are sold or made of PGA (polyglycolic acid, sold under the trademark Vicryl), PCL (polycaprolactone), PLA or PLLA (polylactic acid), PHA (poly Hydroxyalkanoates), PGCL (polycapron 25, sold under the trademark Monocryl) or other biodegradable membranes formed from complexes of PGA, PCL, PLA, PDS which are only permeable when ruptured . The main body 31 of the staple cartridge 30 is sized to be removably supported within the elongated channel 14 as shown so that when the anvil 20 is driven into contact with the staple cartridge 30, each staple therein 32 are each aligned with corresponding staple forming pockets 23 in the anvil.

In use, once the end effector 12 is positioned adjacent to the target tissue, the end effector 12 is manipulated to capture or clamp the target tissue between the top surface 36 of the staple cartridge 30 and the staple forming surface 22 of the anvil 20 between. The staples 32 are formed by moving the anvil 20 in a path substantially parallel to the elongated channel 14 so that the staple forming surfaces 22, and more specifically the staple forming pockets 23 therein, contact the staple cartridge 30 substantially simultaneously. 36 of the top surface. As the anvil 20 continues to move into the staple cartridge 30, the legs 34 of the staples 32 contact corresponding staple forming pockets 23 in the anvil 20 for bending the staple legs 34 to form the staples 32 into "Shape B". Further movement of the anvil 20 toward the elongated channel 14 will further compress and form the staples 32 to the desired final formed height "FF".

The above nail forming process is generally shown in FIG. 1B-FIG. 1E. For example, FIG. 1B shows end effector 12 with target tissue “T” positioned between anvil 20 and top surface 36 of implantable staple cartridge 30 . 1C shows the initial clamping position of the anvil 20, wherein the anvil 20 has been closed onto the target tissue "T" to clamp the target tissue "T" between the anvil 20 and the top surface 36 of the staple cartridge 30 between. FIG. 1D shows initial staple formation where the anvil 20 has begun to compress the staple cartridge 30 such that the legs 34 of the staples 32 begin to form through the staple forming pockets 23 in the anvil 20 . Figure IE shows staples 32 in a final formed condition through target tissue "T" with anvil 20 removed for clarity. Once the staples 32 are formed and fastened to the target tissue "T", the surgeon moves the anvil 20 to the open position to enable the cartridge body 31 and staples 32 to remain attached to the end effector 12 when withdrawing from the patient. target tissue. When the two jaws 13, 15 are clamped together, the end effector 12 forms all the staples simultaneously. The remaining "crushed" body material 31 acts as a hemostat (ORC) and staple line reinforcer (PGA, PDS, or any of the other film compositions 38 described above). Furthermore, since the staples 32 do not have to exit the cartridge body 31 during forming, the likelihood of the staples 32 becoming misshapen during forming is minimized. As used herein, the term "implantable" means that in addition to the staples, the cartridge body material supporting the staples will also be retained within the patient's body and can eventually be absorbed by the patient's body. Such implantable staple cartridges are distinguished from previous staple cartridge configurations that remain fully positioned within the end effector after they have been fired.

In various implementations, the end effector 12 can be coupled to an elongated shaft assembly 40 protruding from the handle assembly 100 . The end effector 12 (when closed) and the elongate shaft assembly 40 may have similar cross-sectional shapes and be sized to operatively pass through a trocar tube or working channel as another access instrument. As used herein, the term "operably passed through" means that at least a portion of the end effector and elongated shaft assembly can be inserted through or passed through a channel or tube opening, and optionally in the channel or tube opening. It is manipulated through the opening to complete the surgical closure. When in the closed position, the jaws 13 and 15 of the end effector 12 may provide the end effector with a generally circular cross-sectional shape to facilitate its passage through the circular passageway/opening. However, other cross-sectional shapes are contemplated for end effectors and elongated shaft assemblies of the present invention so that access passages and openings having non-circular cross-sectional shapes can be passed through in other ways. Thus, the overall size of the cross-section of a closed end effector will be related to the size of the passageway or opening through which the end effector is intended to pass. Thus, an end effector, for example, may be referred to as a "5 mm" end effector, meaning that it is capable of operatively passing through an opening that is at least about 5 mm in diameter.

The elongated shaft assembly 40 may have an outer diameter substantially equal to the outer diameter of the end effector 12 in the closed position. For example, a 5 mm end effector may be coupled to an elongated shaft assembly 40 having a 5 mm cross-sectional diameter. However, with continued reference to the detailed description, it will become apparent that the present invention may be effectively used with end effectors of different sizes. For example, a 10mm end effector may be attached to an elongated shaft with a 5mm cross-sectional diameter. Conversely, for applications where an access opening or passageway of 10mm or greater is provided, the elongate shaft assembly 40 may have a cross-sectional diameter of 10mm (or greater), but is also capable of actuating a 5mm or 10mm end effector. Thus, the outer diameter of the outer shaft 40 may be the same or different than the outer diameter of the closed end effector 12 to which it is attached.

As shown, elongated shaft assembly 40 extends distally from handle assembly 100 generally along a line to define longitudinal axis A-A. For example, the elongated shaft assembly 40 may be approximately 9-16 inches (229-406 mm) long. However, the elongated shaft assembly 40 may be provided at other lengths, or may have a joint therein or otherwise be capable of facilitating articulation of the end effector 12 relative to the shaft or other portion of the handle assembly, as will be described in more detail below. to discuss. Elongated shaft assembly 40 includes a spine member 50 that extends from handle assembly 100 to end effector 12 . The proximal end of the elongated channel 14 of the end effector 12 has a pair of retaining lugs 17 protruding therefrom, the pair of retaining lugs being dimensioned to receive a shank provided in the distal end of the spine member 50. Corresponding lug openings or brackets 52 are provided to enable end effector 12 to be removably coupled to elongate shaft assembly 40 . Spine member 50 may be made of, for example, 6061 or 7075 aluminum, stainless steel, titanium, or the like.

The handle assembly 100 includes a pistol grip type housing that may be made in two or more parts for assembly purposes. For example, the handle assembly 100 as shown includes a right-hand housing member 102 and a left-hand housing member (not shown) molded or otherwise made from a polymer or plastic material and designed to fit together. ). Such housing components may be attached together by snap features, pegs, and sockets molded or otherwise formed therein, and/or by adhesives, screws, and the like. The spine member 50 has a proximal end 54 on which a flange 56 is formed. The flange 56 is rotatably supported in a channel 106 formed by a mating rib 108 projecting inwardly from each of the housing members 102 , 104 . Such a configuration facilitates attachment of spine member 50 to handle assembly 100 while enabling rotation of spine member 50 relative to handle assembly 100 along a 360° path about longitudinal axis A-A.

As can further be seen in FIG. 1 , spine member 50 passes through and is supported by mounting bushing 60 , which is rotatably attached to handle assembly 100 . Mounting bushing 60 has proximal flange 62 and distal flange 64 that define a rotational groove 65 capable of rotatably receiving leading edge portion 101 of handle assembly 100 therebetween. This configuration enables the mounting bushing 60 to rotate relative to the handle assembly 100 about the longitudinal axis AA. The spine member 50 is non-rotatably pinned to the mounting bushing 60 by a spine pin 66 . Additionally, a knob 70 is attached to the mounting bushing 60 . For example, the knob 70 has a hollow mounting flange portion 72 sized to receive a portion of the mounting bushing 60 therein. Knob 70 may be made of, for example, glass or carbon filled nylon, polycarbonate, etc., and is also attached to the mounting bushing 60 by a spine pin 66. Additionally, an inwardly projecting retention flange 74 is formed on the mounting flange portion 72 and is extendable into a radial groove 68 formed in the mounting bushing 60 . Thus, the surgeon can rotate spine member 50 (and end effector 12 attached thereto) along a 360° path about longitudinal axis AA by grasping knob 70 and rotating it relative to handle assembly 100 .

Anvil 20 is held in the open position by anvil spring 21 and/or another biasing formation. Anvil 20 is selectively movable from an open position to various closed or clamped and fired positions by a firing system generally designated 109 . The firing system 109 includes a “firing member” 110 that includes a hollow firing tube 110 . Hollow firing tube 110 is axially movable on spine member 50 , thus forming the exterior of elongated shaft assembly 40 . Firing tube 110 may be fabricated from a polymer or other suitable material and has a proximal end that is attached to firing yoke 114 of firing system 109 . For example, firing yoke 114 may be molded to the proximal end of firing tube 110 . However, other fastener configurations may also be used.

As can be seen in FIG. 1 , the firing yoke 114 can be rotatably supported in a support collar 120 that can move axially within the handle assembly 100 . The support collar 120 has a pair of laterally extending fins sized to be slidably received within fin slots formed in the left and right hand housing members. Accordingly, the support collar 120 is axially slidable within the handle housing 100 while enabling the firing yoke 114 and firing tube 110 to rotate relative to the support collar 120 about the longitudinal axis A-A. In accordance with the present invention, a longitudinal slot is provided through firing tube 110 to enable spine pin 66 to extend therethrough into spine member 50 while facilitating axial travel of firing tube 110 over spine member 50 .

Firing system 109 also includes a firing trigger 130 for controlling the axial travel of firing tube 110 over spine member 50 . See Figure 1. Such axial movement along the distal direction of the firing tube 110 to create a firing interaction with the anvil 20 is referred to herein as a "firing action." As can be seen in FIG. 1 , firing trigger 130 is movably or pivotally coupled to handle assembly 100 by pivot pin 132 . A torsion spring 135 is employed to bias the firing trigger 130 away from the pistol grip portion 107 of the handle assembly 100 to an unactuated "open" or home position. As can be seen in FIG. 1 , the firing trigger 130 has an upper portion 134 that is movably attached (pinned) to a firing link 136 that is movably attached (pinned) to the support bushing. Circle 120. Accordingly, movement of the firing trigger 130 from the starting position ( FIG. 1 ) toward the ending position adjacent the pistol grip portion 107 of the handle assembly 100 will cause the firing yoke 114 and firing tube 110 to move in the distal direction "DD". . Movement of the firing trigger 130 away from the pistol grip portion 107 of the handle assembly 100 (under the bias of the torsion spring 135) will cause the firing yoke 114 and firing tube 110 to move on the spine member 50 in the proximal direction “PD”. "sports.

The present invention can be used with implantable staple cartridges of different sizes and configurations. For example, when used in conjunction with first firing adapter 140 , surgical instrument 10 may be used with a 5 mm end effector 12 that is approximately 20 mm long (or otherwise long) that supports implantable staple cartridge 30 . Such an end effector size may be particularly well-suited for, for example, achieving relatively fine dissections and vascular treatments. However, as described in more detail below, surgical instrument 10 may also be used with other sized end effectors and staple cartridges, for example by replacing first firing adapter 140 with a second firing adapter. As a further alternative, the elongated shaft assembly 40 can be attached to only one form or size of end effector.

One method of removably coupling end effector 12 to spine member 50 will now be explained. The coupling process begins by inserting the retaining lugs 17 on the elongated channel 14 into the lug holders 52 in the spine member 50 . Subsequently, the surgeon advances the firing trigger 130 toward the pistol grip 107 of the housing assembly 100 to advance the firing tube 110 and first firing adapter 140 distally over the proximal end portion 47 of the elongated channel 14 , thereby retaining the lugs 17 in their respective brackets 52 . This position of the first firing adapter 140 on the lug 17 is referred to herein as the "coupling position". The present invention may also have an end effector locking assembly for locking the firing trigger 130 in place after the end effector 12 has been attached to the spine member 50 .

More specifically, one embodiment of the end effector lock assembly 160 includes a retaining pin 162 movably supported in the upper portion 134 of the firing trigger 130 . As described above, the firing tube 110 must first be advanced distally to the coupled position wherein the first firing adapter 140 retains the retaining lug 17 of the end effector 12 in the lug bracket 52 in the spine member 50 . The surgeon advances the firing adapter 140 distally to the coupled position by pulling the firing trigger 130 from the starting position toward the pistol grip 107 . When the firing trigger 130 is first actuated, the retaining pin 162 moves distally until the firing tube 110 advances the first firing adapter 140 to the coupled position, at which point the retaining pin 162 is biased into the housing member. in the locking cavity 164 of the Optionally, when the retaining pin 162 enters the locking cavity 164, the pin 162 may emit an audible "click" or other sound and provide the surgeon with an indication that the end effector 12 has been "locked" to the spine member 50. tactile indication on the Additionally, as long as the retaining pin 162 is not intentionally biased out of the locking cavity 164 , the surgeon cannot inadvertently continue to actuate the firing trigger 130 to begin forming the staples 32 in the end effector 12 . Similarly, if the surgeon releases the firing trigger 130 in the coupled position, the retaining pin 162 will keep the firing trigger 130 in this position, preventing the firing trigger 130 from returning to the starting position and thus releasing the end from the spine member 50 Department actuator 12.

The present invention may also include a firing system lock button 137 that is pivotally attached to the handle assembly 100 . In one form, the firing system lockout button 137 has a latch 138 formed on its distal end oriented to engage the firing yoke 114 when the firing release button is in the first latched position. As can be seen in FIG. 1 , a latch spring 139 is used to bias the firing system lock button 137 to the first latched position. In each case, the latch 138 is used to engage the firing yoke 114 at the point at which the position of the firing yoke 114 on the spine member 50 corresponds to where the first firing adapter 140 is about to be advanced distally. Point on clamping slide 28 on anvil 20 . It should be appreciated that as first firing adapter 140 is advanced axially onto clamping chute 28 , anvil 20 will move along a path such that staple forming surface portion 22 is substantially parallel to top surface 36 of staple cartridge 30 .

After the end effector 12 is coupled to the spine member 50, the staple forming process is initiated by first depressing the firing system lock button 137 to enable the firing yoke 114 to move further distally on the spine member 50 and eventually to anvil 20. Compressed into the staple cartridge 30. After depressing the firing system lock button 137, the surgeon proceeds to actuate the firing trigger 130 toward the pistol grip 107, thereby driving the first staple collar 140 onto the corresponding staple forming slide 29 to force the anvil 20 is in forming contact with the staples 32 in the staple cartridge 30. The firing system lock button 137 prevents unintentional shaping of the staples 32 until the surgeon is ready to begin the procedure. In this embodiment, the surgeon must depress the firing system lockout button 137 to begin the staple forming process before the firing trigger 130 can be further actuated.

Surgical instrument 10 may be used only as a tissue stapling device if desired. However, the present invention may also include a tissue cutting system, generally designated 170 . In at least one form, tissue cutting system 170 includes knife member 172 that can be selectively advanced from an unactuated position adjacent the proximal end of side tip effector 12 by actuating knife advancement trigger 200 . to the actuated position. Knife member 172 is movably supported within spine member 50 and is attached to or otherwise protrudes from knife bar 180 . Knife member 172 can be made of, for example, 420 or 440 stainless steel having a hardness greater than 38 HRC (Rockwell C scale), and can have a tissue cutting edge 176 formed on its distal tip 174 and can slidably extend through A slot in anvil 20 and a slot 33 centrally located in cartridge 30 to cut through tissue clamped in end effector 12 . Knife bar 180 extends through spine member 50 and has a proximal end portion in driving interface with a knife transport that is operably attached to knife advance trigger 200 . Knife travel trigger 200 is attached to pivot pin 132 such that it can pivot or otherwise be actuated without actuating firing trigger 130 . According to the present invention, first knife gear 192 is also attached to pivot pin 132 such that actuation of knife travel trigger 200 also pivots first knife gear 192 . A firing return spring 202 is attached between the first knife gear 192 and the handle housing 100 to bias the knife travel trigger 200 to a home or unactuated position.

The knife transmission device also includes a second knife gear 194 rotatably supported on the second gear shaft and meshed with the first knife gear 192 . The second cutter gear 194 meshes with a third cutter gear 196 supported on the third gear shaft. The fourth knife gear 198 is also supported on the third gear shaft 195 . The fourth knife gear 198 can drivingly engage a series of ring gear teeth or rings on the proximal end of the knife bar 180 . Thus, this configuration enables the fourth knife gear 198 to axially drive the knife bar 180 in either the distal direction "DD" or the proximal direction "PD" while the firing rod 180 is about the longitudinal axis A-A relative to the fourth knife gear 198. rotate. Accordingly, the surgeon may axially advance the firing rod 180 and ultimately the knife member 172 distally by pulling the knife advancement trigger 200 toward the pistol grip 107 of the handle assembly 100 .

The present invention also includes a knife locking system 210 that prevents advancement of the knife member 172 unless the firing trigger 130 has been pulled to the fully fired position. Thus, this configuration will prevent activation of the knife advancement system 170 unless the staples have first been fired or formed into the tissue. As can be seen in FIG. 1 , various implementations of the knife locking system 210 include a knife locking bar 211 pivotally supported in the pistol grip portion 107 of the handle assembly 100 . The knife locking lever 211 has an activated end 212 that is engageable by the firing trigger 130 when the firing trigger 130 is in the fully fired position. In addition, the knife locking lever 211 has a retaining hook 214 on its other end which is capable of hooking into a latch lever 216 on the first cutting gear 192 . A knife lock spring 218 is employed to bias the knife lock lever 211 to a "locked" position, wherein the retaining hook 214 remains engaged with the latch lever 216, thereby preventing actuation of the knife travel trigger 200 unless the firing trigger 130 is fully engaged. firing position.

After the staples have been "fired" (formed) into the target tissue, the surgeon can depress the firing trigger release button 167 so that the firing trigger 130 can return to the starting position under the bias of the torsion spring 135, thereby allowing the The anvil 20 is biasable to an open position under the bias of a spring 21 . When in the open position, the surgeon can withdraw end effector 12 leaving implantable staple cartridge 30 and staples 32 behind. In applications where the end effector is inserted through a channel, working channel, etc., the surgeon will return the anvil 20 to the closed position by activating the firing trigger 130 to enable the end effector 12 to pass through the channel or The working channel was withdrawn. However, if the surgeon wants to cut the target tissue after firing the staples, the surgeon activates the knife travel trigger 200 in the manner described above to drive the knife bar 172 through the target tissue to the end of the end effector. Subsequently, the surgeon may release the knife travel trigger 200 to enable the firing return spring 202 to enable the firing delivery mechanism to return the knife bar 172 to the home (non-actuated) position. Once the knife bar 172 is returned to the starting position, the surgeon can open the end effector jaws 13, 15 to release the implantable cartridge 30 in the patient and subsequently withdraw the end effector 12 from the patient. Accordingly, such surgical instruments facilitate the use of small implantable staple cartridges that can be inserted through relatively small working channels and channels, while providing the surgeon with the option of firing the staples without cutting tissue, or Tissue is also cut if desired after firing the staples.

Various unique and novel embodiments of the present invention employ compressible staple cartridges that support staples in a substantially fixed position for forming contact by an anvil. The anvil is driven into the unformed staple, wherein eg the degree of staple formation achieved depends on how far the anvil is driven into the staple. Such configurations enable the surgeon to adjust the amount of forming or firing pressure applied to the staples, thereby varying the final formed height of the staples. In other embodiments of the invention, surgical stapling configurations may employ staple driving elements that lift the staples toward the anvil. These examples are described in more detail below.

Optionally, referring to above, the amount of firing action applied to the movable anvil depends on the degree of actuation of the firing trigger. For example, if the surgeon wishes to obtain only partially formed staples, the firing trigger only needs to be partially depressed inwardly towards the pistol grip 107 . To achieve more staple formation, the surgeon need only further depress the firing trigger, causing the anvil to be driven further into forming contact with the staples. As used herein, the term "forming contact" means that a staple forming surface or staple forming pocket has contacted the end of a staple leg and has begun to form or bend the leg into a formed position. The degree of staple formation refers to the extent to which the staple legs are folded and finally refers to the above-mentioned formed height of the staple. Those of ordinary skill in the art will further appreciate that because the anvil 20 moves in a substantially parallel relationship with the staple cartridge when the firing action is applied to the anvil 20, the staples are formed at substantially the same time and have substantially the same Forming height.

Figures 2 and 3 illustrate an alternative end effector 12", which is similar to the end effector 12' described above except for the following difference in that it can accommodate a knife bar 172'. Knife bar 172' is coupled to or projects from knife bar 180 and otherwise operates in the manner described above with respect to knife bar 172. However, in this embodiment, the knife bar 172' is long enough to traverse the entire length of the end effector 12", so a separate distal knife member is not employed in the end effector 12". Formed on the knife bar 172' are an upper cross member 173' and a lower cross member 175'. The upper cross member 173' is oriented to slide across a corresponding elongated slot 250 in the anvil 20", and the lower cross member 175' is oriented to traverse an elongated slot in the elongated channel 14" of the end effector 12". Slot 252. An escape slot (not shown) is also provided in the anvil 20″ so that when the knife bar 172′ has been driven to the end position within the end effector 12″, the upper cross member 173′ is lowered through through the corresponding slot to allow the anvil 20" to move to the open position to disengage the stapled and cut tissue. The anvil 20" may otherwise be identical to the anvil 20 described above, and the elongated channel 14" may be otherwise identical to the elongated channel 14 described above.

In these embodiments, the anvil 20" is biased by a spring or other opening formation (not shown) to the fully open position (FIG. 2). The anvil 20" is activated by axial travel of the firing adapter 150 in the manner described above. Movement between open and fully clamped positions. Once the firing adapter 150 is advanced to the fully clamped position (FIG. 3), the surgeon can then advance the knife bar 172" distally in the manner described above. If the surgeon wishes to use the end effector as a grasping device to manipulate tissue, The firing adapter can then be moved proximally to allow the anvil 20" to move away from the elongated channel 14", as shown in phantom in Figure 4. In this embodiment, as the knife bar 172" moves distally Together, the upper cross member 173' and lower cross member 175' pull the anvil 20" and elongated channel 14" together to achieve the desired staple formation as the knife bar 172" is advanced distally through the end effector 12". See Figure 5. Thus, in this embodiment, staple forming occurs simultaneously with tissue cutting, but the staples themselves can be sequentially formed as the knife bar 172" is driven distally.

The unique and novel configuration of the various surgical staple cartridges and surgical instruments of the present invention enables the staples in the cartridges to be arranged in one or more linear or non-linear lines. A plurality of such staple wires may be provided on each side of an elongated slot centrally disposed within the staple cartridge for receiving a tissue cutting member therethrough. In one configuration, for example, an aligned line of staples may be generally parallel to but offset from staples in an adjacent line of staples. As a further alternative, the one or more staple lines may be non-linear in nature. That is, the base of at least one staple in the staple line can extend along an axis that is substantially transverse to the bases of other staples in the same staple line. For example, the staple lines on each side of the elongated slot may have a zigzag appearance.

According to the present invention, a staple cartridge may include a cartridge body and a plurality of staples stored in the cartridge body. In use, the staple cartridge can be introduced into the surgical site and positioned lateral to the treated tissue. Additionally, the staple forming anvils can be positioned on opposite sides of the tissue. The anvil can be carried by the first jaw and the staple cartridge can be carried by the second jaw, wherein the first jaw and/or the second jaw can be moved toward the other jaw. Once the staple cartridge and anvil are positioned relative to the tissue, the staples can be ejected from the staple cartridge body such that the staples can pierce the tissue and contact the staple forming anvil. Once the staples are deployed from the staple cartridge body, the staple cartridge body can then be removed from the surgical site. The staple cartridge or at least a portion of the staple cartridge may have staples implanted therein. For example, as described in more detail below, a staple cartridge can include a cartridge body that can be compressed, crushed, and/or collapsed by the anvil as the anvil moves from an open position to a closed position. Staples positioned in the cartridge body may be deformed by the anvil as the cartridge body is compressed, crushed and/or collapsed. Alternatively, the jaws supporting the staple cartridge are movable toward the anvil to a closed position. In either case, the staples may deform when they are at least partially positioned within the cartridge body. In some cases, the staples may not be ejected from the staple cartridge, while in other cases, the staples may be ejected from the staple cartridge along with a portion of the cartridge body.

Referring now to FIGS. 6A-6D , a compressible staple cartridge, such as a staple cartridge 1000, for example, can include a compressible, implantable cartridge body 1010, and in addition a plurality of staples 1020 positioned within the compressible cartridge body 1010, but FIG. 6A - Figure 6D shows only one staple 1020. Figure 6A illustrates a staple cartridge 1000 supported by a cartridge support or cartridge channel 1030, wherein the staple cartridge 1000 is shown in an uncompressed condition. In this uncompressed condition, the anvil 1040 may or may not be in contact with the tissue T. In use, the anvil 1040 is movable from the open position to contact tissue T, as shown in FIG. 6B , and position the tissue T against the cartridge body 1010 . Even though the anvil 1040 can position the tissue T against the tissue contacting surface 1019 of the staple cartridge body 1010, yet again referring to FIG. 6B , the staple cartridge body 1010 can now experience little, if any, compressive force or pressure, And the staples 1020 can remain in an unformed or unfired condition. As shown in FIGS. 6A and 6B , the staple cartridge body 1010 can include one or more layers, and the staple legs 1021 of the staples 1020 can extend upwardly through the layers. The cartridge body 1010 may include a first layer 1011, a second layer 1012, a third layer 1013, and a fourth layer 1014, wherein the second layer 1012 may be positioned intermediate the first layer 1011 and the third layer 1013, wherein the third layer 1013 may be Positioned between the second layer 1012 and the fourth layer 1014 . For example, bases 1022 of staples 1020 can be positioned in cavities 1015 in fourth layer 1014 , and staple legs 1021 can extend upwardly from bases 1022 and through fourth layer 1014 , third layer 1013 , and second layer 1012 . Optionally, each deformable leg 1021 can include a tip, such as a sharp tip 1023, which can be positioned in second layer 1012, for example, when staple cartridge 1000 is in an uncompressed condition. For example, apex 1023 may not extend to and/or pass through first layer 1011, wherein apex 1023 may not protrude through tissue contacting surface 1019 when staple cartridge 1000 is in an uncompressed condition. The sharpened tip 1023 can be positioned in the third layer 1013 and/or any other suitable layer when the staple cartridge is in an uncompressed condition. Alternatively, the cartridge body of the staple cartridge can have any suitable number of layers, such as less than four layers or more than four layers.

Optionally, as described in more detail below, the first layer 1011 may be comprised of a support material and/or a plastic material such as polydioxanone (PDS) and/or polyglycolic acid (PGA), And the second layer 1012 can be composed of a bioabsorbable foam material and/or a compressible hemostatic material (eg, oxidized regenerated cellulose (ORC)). Optionally, one or more of first layer 1011, second layer 1012, third layer 1013, and fourth layer 1014 can retain staples 1020 in staple cartridge body 1010, and can additionally retain staples 1020 relative to each other. align. The third layer 1013 may be composed of a strut material or a relatively incompressible or non-elastic material capable of holding the staple legs 1021 of the staples 1020 in place relative to each other. Additionally, the second layer 1012 and fourth layer 1014 positioned on opposite sides of the third layer 1013 can stabilize or reduce movement of the staples 1020, even though the second layer 1012 and fourth layer 1014 can be composed of a compressible foam or elastic material . The staple tips 1023 of the staple legs 1021 can be at least partially embedded in the first layer 1011 . For example, first layer 1011 and third layer 1013 can cooperatively and securely hold staple legs 1021 in place. The first layer 1011 and the third layer 1013 may respectively be made of, for example, a bioabsorbable material such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS) sold under the trade name Vicryl , polyhydroxyalkanoate (PHA), polycapron 25 (PGCL) sold under the tradename Monocryl, polycaprolactone (PCL), and/or PGA, PLA, PDS, PHA, PGCL, and/or PCL composite), and the second layer 1012 and the fourth layer 1014 may each be composed of at least one hemostatic material or hemostat.

While the first layer 1011 may be compressible, the second layer 1012 may be substantially more compressible than the first layer 1011 . For example, the second layer 1012 may be about two times, about three times, about four times, about five times, and/or about ten times as compressible as the first layer 1011. In other words, for a given force, the second layer 1012 may be about two times, about three times, about four times, about five times, and/or about ten times as compressible as the first layer 1011. The compressibility of the second layer 1012 may be, for example, between about twice and about ten times that of the first layer 1011 . The second layer 1012 can include a plurality of air gaps defined therein, wherein the amount and/or size of the air gaps in the second layer 1012 can be controlled to provide a desired compressibility of the second layer 1012 . Similar to above, while third layer 1013 may be compressible, fourth layer 1014 can be substantially more compressible than third layer 1013 . For example, fourth layer 1014 may be about twice, about three times, about four times, about five times, and/or about ten times as compressible as third layer 1013 . In other words, fourth layer 1014 may be about two times, about three times, about four times, about five times, and/or about ten times more compressible than third layer 1013 for a given force. The compressibility of the fourth layer 1014 may be between about two times and about ten times that of the third layer 1013 . The fourth layer 1014 may include a plurality of air gaps defined therein, wherein the amount and/or size of the air gaps in the fourth layer 1014 may be controlled in order to provide a desired compressibility of the fourth layer 1014 . In each case, the compressibility of a cartridge body or a layer of a cartridge body can be expressed in terms of compressibility (ie, the distance a layer compresses for a given magnitude of force). For example, a layer with a high compressibility will compress a greater distance for a given amount of compressive force applied to the layer than a layer with a lower compressibility. As such, the second layer 1012 may have a higher compressibility than the first layer 1011 ; similarly, the fourth layer 1014 may have a higher compressibility than the third layer 1013 . The second layer 1012 and the fourth layer 1014 may be composed of the same material and may have the same compressibility. The second layer 1012 and the fourth layer 1014 may be composed of materials having different compressibility. Similarly, the first layer 1011 and the third layer 1013 may be composed of the same material and may have the same compressibility. The first layer 1011 and the third layer 1013 may be composed of materials having different compressibility.

As the anvil 1040 is advanced toward its closed position, the anvil 1040 can contact the tissue T and apply a compressive force to the tissue T and the staple cartridge 1000, as shown in FIG. 6C. In this case, the anvil 1040 can push the top surface or tissue contacting surface 1019 of the cartridge body 1010 downward toward the staple cartridge buttress 1030 . The staple cartridge support 1030 can include a cartridge support surface 1031 configured to support the staple cartridge 1000 when the staple cartridge 1000 is compressed between the cartridge support surface 1031 and the tissue contacting surface 1041 of the anvil 1040 . Due to the pressure exerted by the anvil 1040 , the cartridge body 1010 can be compressed and the anvil 1040 can contact the staples 1020 . More specifically, compression of the cartridge body 1010 and downward movement of the tissue contacting surface 1019 can cause the tips 1023 of the staple legs 1021 to pierce the first layer 1011 of the cartridge body 1010, penetrate the tissue T, and enter the formed shape in the anvil 1040. In the pit 1042. As the cartridge body 1010 is further compressed by the anvil 1040, the tip 1023 can contact the walls defining the forming pocket 1042, and the legs 1021 can deform or curl inwardly as a result, for example, as shown in FIG. 6C. When staple legs 1021 are deformed, as also shown in FIG. 6C , bases 1022 of staples 1020 can contact or be supported by cartridge support 1030 . Optionally, as described in more detail below, the staple cartridge support 1030 can include a plurality of support structures, such as staple support grooves, slots, or grooves 1032, for example, capable of supporting the staples 1020 as they are deformed. The staple 1020 or at least the base 1022 of the staple 1020 . As also shown in FIG. 6C , a compressive force applied to the cartridge body 1010 can cause the cavities 1015 in the fourth layer 1014 to collapse. In addition to cavity 1015, staple cartridge body 1010 may also include one or more voids, such as void 1016, which may or may not include, for example, a portion of a staple positioned therein, the one or more voids. One or more voids can allow the cartridge body 1010 to collapse. The cavity 1015 and/or void 1016 can be collapsed such that the walls defining the cavity and/or walls deflect downward and contact the cartridge support surface 1031 and/or contact a layer of the cartridge body 1010 positioned below the cavity and/or void .

When comparing FIGS. 6B and 6C , it is apparent that the second layer 1012 and the fourth layer 1014 are substantially compressed by the compressive pressure applied by the anvil 1040 . It may also be noted that the first layer 1011 and the third layer 1013 are also compressed. As the anvil 1040 moves to its closed position, the anvil 1040 can continue to further compress the cartridge body 1010 by pushing the tissue contacting surface 1019 downward toward the staple cartridge buttress 1030 . When the cartridge body 1010 is further compressed, the anvil 1040 can deform the staples 1020 to their fully formed shape, as shown in Figure 6D. Referring to FIG. 6D , the legs 1021 of each staple 1020 can be deformed downward toward the base 1022 of each staple 1020 so as to deform at least A portion is captured between the deformable leg 1021 and the base 1022 . When comparing FIGS. 6C and 6D , it is more apparent that the second layer 1012 and the fourth layer 1014 are further compressed significantly by the compressive pressure applied by the anvil 1040 . It can also be noted when comparing Figures 6C and 6D that the first layer 1011 and the third layer 1013 are also further compressed. After the staples 1020 are fully, or at least sufficiently, formed, the anvil 1040 can be lifted away from the tissue T and the staple cartridge buttress 1030 can be moved away from and/or out of the staple cartridge 1000 . As shown in Figure 6D and as described above, the cartridge body 1010 can be implanted with staples 1020. In various embodiments, the implanted cartridge body 1010 can support tissue along the staple line. In some cases, the hemostatic agent and/or any other suitable therapeutic agent contained within the implanted cartridge body 1010 can treat the tissue over time. A hemostat as described above can reduce bleeding from sutured and/or cut tissue, while a bonding agent or tissue adhesive can provide strength to the tissue over time. The implanted cartridge body 1010 can be made of materials such as ORC (oxidized regenerated cellulose), extracellular proteins such as collagen, polyglycolic acid (PGA) sold under the trade name Vicryl, polylactic acid (PLA or PLLA), polydioxa Cyclohexanone (PDS), polyhydroxyalkanoate (PHA), polycapron 25 (PGCL) sold under the tradename Monocryl, polycaprolactone (PCL), and/or PGA, PLA, PDS, PHA , PGCL and/or PCL composite materials. In some cases, cartridge body 1010 may include, for example, an antimicrobial and/or antimicrobial material, such as colloidal silver and/or triclosan, that can reduce the likelihood of surgical site infection.

The layers of the cartridge body 1010 may be interconnected. For example, the second layer 1012 may be adhered to the first layer 1011, the third layer 1013 may be adhered to the second layer 1012 using at least one adhesive such as fibrin and/or protein hydrogel, and The fourth layer 1014 is adhered to the third layer 1013 . Although not shown, the layers of the cartridge body 1010 may be joined together by interlocking mechanical features. For example, first layer 1011 and second layer 1012 may each include corresponding interlocking features, such as tongue and groove and/or dovetail. Similarly, second layer 1012 and third layer 1013 can each include corresponding interlocking features, while third layer 1013 and fourth layer 1014 can each include corresponding interlocking features. Although not shown, staple cartridge 1000 may include, for example, one or more rivets that may extend through one or more layers of cartridge body 1010 . For example, each rivet can include a first end or head positioned adjacent to the first layer 1011 and a second head positioned adjacent to the fourth layer 1014, which can be assembled to the second end of the rivet or formed by the rivet. The second end is formed. For example, due to the compressible nature of the cartridge body 1010 , the rivet can compress the cartridge body 1010 such that the head of the rivet can be recessed relative to the tissue contacting surface 1019 and/or the bottom surface 1018 of the cartridge body 1010 . For example, rivets can be made of bioabsorbable materials such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate ( PHA), polycapron 25 (PGCL), polycaprolactone (PCL), and/or complexes of PGA, PLA, PDS, PHA, PGCL, and/or PCL sold under the tradename Monocryl). The layers of the cartridge body 1010 may not be connected to each other except through the staples 1020 contained in the cartridge body 1010 . For example, frictional engagement between the staple legs 1021 and the cartridge body 1010 can hold the layers of the cartridge body 1010 together, for example, and the layers can be captured in the staple 1020 once the staple is formed. At least a portion of the staple legs 1021 can include a roughened surface or rough coating that can increase friction between the staples 1020 and the cartridge body 1010 .

As described above, the surgical instrument can include a first jaw including the cartridge buttress 1030 and a second jaw including the anvil 1040 . Optionally, as described in more detail below, staple cartridge 1000 may include one or more retaining features capable of engaging staple cartridge buttress 1030 and thereby releasably retaining staple cartridge 1000 to Cartridge support 1030. For example, cartridge 1000 can be adhered to cartridge buttress 1030 by at least one adhesive, such as fibrin and/or protein hydrogel. In use, in at least one instance, especially in laparoscopic and/or endoscopic procedures, the second jaw is moveable to a closed position opposite the first jaw, for example such that the first jaw and the second jaw can be inserted through the trocar into the surgical site. For example, the trocar may define an approximately 5mm hole or cannula through which the first and second jaws may be inserted. The second jaw is movable to a partially closed position between an open position and a closed position, which allows the first and second jaws to be inserted through the trocar without requiring the staple cartridge body 1010 to be inserted. The nails 1020 contained in the deformed. For example, when the second jaw is in its partially closed intermediate position, the anvil 1040 may not exert a compressive force on the staple cartridge body 1010, but when the second jaw is in its partially closed intermediate position, the anvil 1040 may compress the staples. Warehouse body 1010. Although the staple cartridge body 1010 can be compressed when the anvil 1040 is in such an intermediate position, the anvil 1040 can not completely compress the staple cartridge body 1010 such that the anvil 1040 contacts the staples 1020 and/or causes the staples 1020 to be deformed by the anvil 1040. Once the first and second jaws have been inserted through the trocar into the surgical site, the second jaw can be opened again and the anvil 1040 and staple cartridge 1000 can be positioned relative to the target tissue as described above.

Referring now to FIGS. 7A-7D , an end effector of a surgical stapler can include an implantable staple cartridge 1100 positioned intermediate an anvil 1140 and a cartridge buttress 1130 . Similar to the above, the anvil 1140 can include a tissue contacting surface 1141 , the staple cartridge 1100 can include a tissue contacting surface 1119 , and the staple cartridge buttress 1130 can include a support surface 1131 capable of supporting the staple cartridge 1100 . 7A, anvil 1140 can be utilized to position tissue T against tissue contacting surface 1119 of staple cartridge 1100 without deforming staple cartridge 1100, and when anvil 1140 is in this position, tissue contacting surface 1141 can be positioned A distance 1101a from the cartridge supporting surface 1131, and the tissue contacting surface 1119 can be positioned a distance 1102a from the cartridge supporting surface 1131. Subsequently, when the anvil block 1140 moves toward the staple cartridge buttress 1130, referring now to FIG. 1112 on the second floor. As layers 1111 and 1112 are compressed, referring again to FIG. 7B , second layer 1112 can be crushed and legs 1121 of staples 1120 can pierce first layer 1111 and into tissue T. Referring now to FIG. For example, staples 1120 can be positioned at least partially in staple cavities or voids 1115 in second layer 1112, and when second layer 1112 is compressed, staple cavities 1115 can collapse and thus allow second layer 1112 to collapse around staples 1120 shrink. The second layer 1112 can include a cover portion 1116 that can extend over and surround, or at least partially surround, the staple cavities 1115 . FIG. 7B shows the cover 1116 being crushed down into the staple cavity 1115 . Second layer 1112 may include one or more weakened portions that may facilitate collapse of second layer 1112 . Optionally, such weakened portions may include, for example, score marks, perforations, and/or thin cross-sections that can facilitate controlled collapse of the cartridge body 1110 . The first layer 1111 can include one or more weakened portions that can facilitate penetration of the staple legs 1121 through the first layer 1111 . Optionally, such weakened portions may include, for example, scores, perforations, and/or thinned cross-sections capable of aligning, or at least substantially aligning, with staple legs 1121 .

Referring again to FIG. 7A , when the anvil 1140 is in the partially closed unfired position, the anvil 1140 can be positioned a distance 1101a from the cartridge support surface 1131 such that a gap is defined therebetween. This gap can be filled by a staple cartridge 1100 having a cartridge height 1102a and tissue T. As the anvil 1140 moves downward to compress the staple cartridge 1100, referring again to FIG. 7B, the distance between the tissue contacting surface 1141 and the cartridge supporting surface 1131 can be defined by a distance 1101b that is shorter than distance 1101a. In various instances, the gap defined by the distance 1101b between the tissue contacting surface 1141 of the anvil 1140 and the cartridge support surface 1131 can be greater than the original undeformed cartridge height 1102a. Referring now to FIG. 7C , as the anvil 1140 is moved closer to the cartridge support surface 1131 , the second layer 1112 can continue to collapse and the distance between the staple legs 1121 and the forming pockets 1142 can decrease. Similarly, the distance between the tissue contacting surface 1141 and the cartridge support surface 1131 can be reduced to a distance 1101c, which can be greater than, equal to, or less than the original undeformed cartridge height 1102a. Referring now to FIG. 7D , anvil 1140 can be moved to a final fired position in which staples 1120 are fully formed, or at least formed to a desired height. In such a position, the tissue-contacting surface 1141 of the anvil 1140 can be a distance 1101d from the cartridge support surface 1131, where the distance 1101d can be shorter than the original undeformed cartridge height 1102a. As also shown in FIG. 7D , the staple cavities 1115 can be completely or at least substantially collapsed, and the staples 1120 can be completely or at least substantially surrounded by the collapsed second layer 1112 . In various circumstances, anvil 1140 can then be moved away from staple cartridge 1100 . For example, once the anvil 1140 is disengaged from the staple cartridge 1100, the cartridge body 1110 can be re-expanded, eg, at least partially, in various positions (ie, positions between adjacent staples 1120). A collapsed cartridge body 1110 may not resiliently expand again. The shaped staples 1120 and the cartridge body 1110 otherwise positioned between adjacent staples 1120 can apply pressure or compressive forces to the tissue T, which can provide various therapeutic benefits.

As noted above, referring again to FIG. 7A , each staple 1120 can include a staple leg 1121 extending therefrom. For example, although staple 1120 is depicted as including two staple legs 1121, staples that may include one staple leg or alternatively include more than two staple legs (such as three staple legs or four staple legs) may also be utilized. Various nails. As shown in FIG. 7A , each staple leg 1121 can be embedded in the second layer 1112 of the cartridge body 1110 such that the staple 1120 is fixed in the second layer 1112 . Staples 1120 can be inserted into staple cavities 1115 in cartridge body 1110 such that tips 1123 of staple legs 1121 enter cavities 1115 before bases 1122 . After tip 1123 is inserted into cavity 1115 , tip 1123 may be pressed into cap portion 1116 and cut second layer 1112 . The staples 1120 can be seated to a sufficient depth into the second layer 1112 such that the staples 1120 do not move, or at least substantially do not, relative to the second layer 1112 . The staples 1120 can be seated to a sufficient depth into the second layer 1112 such that the bases 1122 are positioned or embedded in the staple cavities 1115 . Alternatively, the base 1122 may not be positioned or embedded in the second layer 1112 . Referring again to FIG. 7A , the base 1122 can extend below the bottom surface 1118 of the cartridge body 1110 . The base 1122 can rest on or be positioned directly against the cartridge support surface 1130 . The cartridge support surface 1130 can include support structures extending therefrom and/or defined therein, for example, the bases 1122 of the staples 1120 can be positioned in one or more support grooves, slots or slots in the staple cartridge support 1130, for example 1132 is supported in or by the one or more support grooves, slots or grooves 1132, as will be described in more detail below.

Referring now to FIGS. 8 and 9 , a staple cartridge, such as staple cartridge 1200 , for example, can include a compressible implantable cartridge body 1210 that includes an outer layer 1211 and an inner layer 1212 . Similar to the above, staple cartridge 1200 can include a plurality of staples 1220 positioned within cartridge body 1210 . Optionally, each staple 1220 can include a base 1222 and one or more staple legs 1221 extending therefrom. For example, staple legs 1221 may be inserted into inner layer 1212 and seated to a depth such that bases 1222 of staples 1220 abut and/or are positioned adjacent bottom surface 1218 of inner layer 1212 . In FIGS. 8 and 9 , inner layer 1212 does not include staple cavities capable of receiving a portion of staples 1220 , while alternatively, inner layer 1212 may include such staple cavities. Further to the above, the inner layer 1212 can be constructed of a compressible material capable of allowing the cartridge body 1210 to collapse when a compressive load is applied thereto, such as bioabsorbable foam and/or oxidized regenerated cellulose (ORC). The inner layer 1212 may be composed of, for example, a lyophilized foam comprising polylactic acid (PLA) and/or polyglycolic acid (PGA). ORC is commercially available under the tradename Surgicel and may include fluffed woven fabric (like a surgical sponge), fluffed fibers (like cotton balls), and/or foam. The inner layer 1212 may be constructed of a material containing and/or coated thereon with a drug, such as freeze-dried thrombin and/or fibrin, that is activated and/or activated, for example, by fluid water in the patient's body. For example, lyophilized thrombin and/or fibrin can be maintained on a matrix such as Vicryl (PGA). However, under certain circumstances, such as when staple cartridge 1200 is inserted into a surgical site in a patient, the activatable drug may be unintentionally activated. Referring again to FIGS. 8 and 9 , the outer layer 1211 can be constructed of a water-impermeable or at least substantially water-impermeable material such that liquids do not contact or at least substantially do not contact the inner layer 1212 until the cartridge body 1210 has been compressed and the staple legs have been compressed. After the outer layer 1211 has been penetrated and/or after the outer layer 1211 has been cut in some way. For example, the outer layer 1211 may be composed of a support material and/or a plastic material such as polydioxanone (PDS) and/or polyglycolic acid (PGA). Outer layer 1211 may include a wrap surrounding inner layer 1212 and staples 1220 . More specifically, staples 1220 may be inserted into inner layer 1212 and outer layer 1211 and wrapped and then sealed around the subassembly including inner layer 1212 and staples 1220 .

As described herein, the staples of the staple cartridge can be fully formed by the anvil when the anvil is moved to the closed position. Alternatively, referring now to FIGS. 10-13 , the staples of a staple cartridge such as staple cartridge 4100 may pass through the anvil when the anvil is moved to the closed position, and additionally by moving the staples toward the closed anvil, for example. deformed by the nail driver system. Staple cartridge 4100 can include a compressible cartridge body 4110 , which can be constructed, for example, of a foam material, and a plurality of staples 4120 positioned at least partially within compressible cartridge body 4110 . The staple driver system can include a driver holder 4160, a plurality of staple drivers 4162 positioned within the driver holder 4160, and a staple cartridge tray 4180 configured to retain the staple drivers 4162 in the driver holder 4160. For example, the staple drivers 4162 can be positioned within one or more slots 4163 in the driver holder 4160, wherein the sidewalls of the slots 4163 can help guide the staple drivers 4162 upwardly toward the anvil. Staples 4120 can be supported within slots 4163 by staple drivers 4162, wherein staples 4120 can be fully positioned in slots 4163 when staples 4120 and staple drivers 4162 are in their unfired positions. Alternatively, at least a portion of the staples 4120 can extend upwardly through the open ends 4161 of the slots 4163 when the staples 4120 and staple drivers 4162 are in their unfired positions. For example, referring now primarily to FIG. 11 , the bases of the staples 4120 can be positioned within the driver holder 4160 and the tips of the staples 4120 can be embedded within the compressible cartridge body 4110 . About one-third of the height of the staples 4120 can be positioned within the driver holder 4160 , and about two-thirds of the height of the staples 4120 can be positioned within the cartridge body 4110 . Referring to FIG. 10A , for example, staple cartridge 4100 may also include a water impermeable wrap or membrane 4111 surrounding cartridge body 4110 and driver holder 4160 .

In use, for example, a staple cartridge 4100 can be positioned within the staple cartridge channel and the anvil can be moved toward the staple cartridge 4100 to a closed position. When the anvil is moved to its closed position, the anvil can contact and compress the compressible cartridge body 4110. The anvil may not contact the staples 4120 when the anvil is in its closed position. When the anvil is moved to its closed position, the anvil can contact the legs of the staples 4120 and at least partially deform the staples 4120. In either case, the staple cartridge 4100 can also include one or more sleds 4170 that can be advanced longitudinally within the staple cartridge 4100 such that the sleds 4170 can subsequently engage the staple drivers 4162 and cause the staple drivers to 4162 and staples 4120 are moved toward the anvil. Slider 4170 is slidable between staple cartridge tray 4180 and staple drivers 4162 . Where the closing of the anvil has initiated the forming process of the staples 4120, upward movement of the staples 4120 toward the anvil can complete the forming process and deform the staples 4120 to their fully formed height, or at least a desired height. Without the closure of the anvil deforming the staples 4120, upward movement of the staples 4120 toward the anvil can initiate and complete the forming process and deform the staples 4120 to their fully formed height, or at least a desired height. The sled 4170 can be advanced from the proximal end of the staple cartridge 4100 to the distal end of the staple cartridge 4100 such that the staples 4120 positioned in the distal end of the staple cartridge 4100 are positioned at the proximal end of the staple cartridge 4100 before they are fully formed. The staples 4120 in are fully formed. Referring to FIG. 12 , sliders 4170 can each include at least one angled or sloped surface 4711 that can slide under staple drivers 4162 and lift staple drivers 4162 as shown in FIG. 13 .

Further to the above, the staples 4120 can be shaped to capture at least a portion of the tissue T and at least a portion of the compressible cartridge body 4110 of the staple cartridge 4100 therein. After the staples 4120 are formed, the anvil of the surgical stapler and the staple cartridge channel 4130 can be moved away from the implanted staple cartridge 4100 . In various circumstances, the cartridge tray 4180 can be fixedly engaged with the staple cartridge channel 4130, wherein as a result, the cartridge tray 4180 can engage the compressible cartridge body 4110 when the staple cartridge channel 4130 is pulled away from the implanted cartridge body 4110 separate. Referring again to FIG. 10 , the cartridge tray 4180 can include opposing side walls 4181 between which the cartridge body 4110 can be removably positioned. For example, the compressible cartridge body 4110 can be compressed between the side walls 4181 so that the cartridge body 4110 can be removably retained therebetween during use and when the cartridge tray 4180 is pulled away, the cartridge body 4110 is removed from the cartridge tray 4180. Releasably disengaged. For example, driver holder 4160 can be coupled to cartridge tray 4180 such that driver holder 4160, driver 4162, and/or slide 4170 can remain in cartridge tray 4180 when cartridge tray 4180 is removed from the surgical site. Driver 4162 can be ejected from driver holder 4160 and left in the surgical site. For example, the driver 4162 can be made of a bioabsorbable material such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone (PDS), polyhydroxyalkanoate, sold under the tradename Vicryl. (PHA), polycapron 25 (PGCL) sold under the trade name Monocryl, polycaprolactone (PCL), and/or complexes of PGA, PLA, PDS, PHA, PGCL and/or PCL). Driver 4162 can be attached to staple 4120 such that driver 4162 deploys staple 4120 . For example, each driver 4162 can include, for example, a slot configured to receive the base of a staple 4120, wherein the slot can receive the base of the staple in a press-fit and/or snap-fit manner.

Further to the above, the driver holder 4160 and/or the slide 4170 can be ejected from the cartridge tray 4180 . For example, the slider 4170 can slide between the cartridge tray 4180 and the driver holder 4160 such that when the slider 4170 is advanced to drive the staple drivers 4162 and the staples 4120 upward, the slider 4170 can also move the driver holder 4160 upwardly To warehouse 4180 outside. For example, the driver holder 4160 and/or slide 4170 may be made of a bioabsorbable material such as polyglycolic acid (PGA), polylactic acid (PLA or PLLA), polydioxanone ( PDS), polyhydroxyalkanoate (PHA), polycapron 25 (PGCL) sold under the tradename Monocryl, polycaprolactone (PCL), and/or PGA, PLA, PDS, PHA, PGCL and/or or a complex of PCL). The sled 4170 can be integrally formed and/or attached to a drive bar or cutting member that pushes the sled 4170 through the staple cartridge 4100 . In such cases, the sled 4170 may not be ejected from the cartridge tray 4180 and may remain with the surgical stapler, whereas in other cases where the sled 4170 is not attached to the drive rod, the sled 4170 may remain at the surgical site middle. In any event, further to the above, the compressibility of the cartridge body 4110 may allow the use of thicker staple cartridges in the end effector of a surgical stapler because when the anvil of the stapler is closed, Cartridge body 4110 can be compressed or collapsed. As a result of the staples being at least partially deformed when the anvil is closed, taller staples (such as staples having a staple height of about 0.18" can be used, for example, where a staple height of about 0.12" can be positioned in the compressible layer 4110 , and wherein the compressible layer 4110 can have an uncompressed height of about 0.14".

As described herein, a staple cartridge can include a plurality of staples therein. Optionally, such staples may be constructed of metal wire deformed into a substantially U-shaped configuration with two staple legs. Alternatives are contemplated where the staple may comprise a different configuration, such as two or more wires joined together and having three or more staple legs. The one or more wires used to form the staple may comprise a round or at least substantially round cross-section. The staple wire may comprise any other suitable cross-section, such as a square and/or rectangular cross-section. The nails may consist of plastic wire. The nails may consist of metal wires coated with plastic. According to the present invention, the cartridge may comprise any suitable type of fastener in addition to or instead of staples. For example, such fasteners may include pivotable arms that fold when engaged by the anvil. Two-part fasteners may be used. For example, the staple cartridge can include a plurality of first fastener portions, and the anvil can include a plurality of second fastener portions; when the anvil is compressed against the staple cartridge, the second fastener portions are connected to the first fastener portions. A fastener part. As noted above, the sled or driver can be advanced within the staple cartridge to complete the staple forming process. A slide or driver can be advanced within the anvil to move the one or more forming members downward into engagement with the opposing staple cartridge and staples or fasteners positioned in the staple cartridge.

As described herein, a staple cartridge can include four rows of staples stored therein. The four rows of staples may be arranged as two inner staple rows and two outer staple rows. For example, the inner row of staples and the outer row of staples can be positioned on a first side of the cutting member or knife slot in the staple cartridge; similarly, the inner row of staples and the outer row of staples can be positioned on the cutting member or the knife slot. on the second side. A staple cartridge may not include a cutting member slot; however, instead of a staple cartridge slot, such a staple cartridge may include a designated portion that can be cut into by the cutting member. Similarly, the inner rows of staples can be arranged within the staple cartridge such that they are spaced equidistantly, or at least substantially equidistantly, from the cutting member slots. Similarly, the outer rows of staples can be arranged within the staple cartridge such that they are spaced equidistantly, or at least substantially equidistantly, from the cutting member slots. According to the present invention, a staple cartridge may include more or less than four rows of staples stored within the staple cartridge. The staple cartridge may include six rows of staples. For example, the staple cartridge can include three rows of staples on a first side of the cutting member slot and three rows of staples on a second side of the cutting member slot. The staple cartridge may include odd rows of staples. For example, the staple cartridge may include two rows of staples on a first side of the cutting member slot and three rows of staples on a second side of the cutting member slot. The rows of staples may comprise staples having the same, or at least substantially the same, unformed staple height. Alternatively, one or more rows of staples may include staples having a different unformed staple height than the other staples. For example, the staples on a first side of the cutting member slot can have a first unformed height, and the staples on a second side of the cutting member slot can have a second unformed height that is different from the first unformed height. a height.

Optionally, as described above, the staple cartridge may include a cartridge body including a plurality of staple cavities defined therein. The cartridge body can include a deck and a top deck surface, wherein each staple cavity can define an opening in the deck surface. As also described above, staples can be positioned within each staple cavity such that the staples are stored within the cartridge body until they are ejected from the cartridge body. The staples may be contained within the cartridge body prior to being ejected from the cartridge body such that the staples do not protrude above the deck surface. In such cases, when the staples are positioned below the deck surface, the likelihood of the staples being damaged and/or prematurely contacting the target tissue can be reduced. In each case, the staple is movable between an unfired position, in which it does not protrude from the cartridge body, and a fired position, in which it has emerged from the cartridge body and is accessible to be positioned on the staple. The anvil opposite the bin. The anvil and/or forming pockets defined within the anvil may be positioned a predetermined distance above the deck surface such that when the staples are deployed from the cartridge body, the staples deform to a predetermined formed height. In some cases, the thickness of the tissue captured between the anvil and the staple cartridge can vary, so that thicker tissue can be captured in some staples and thinner tissue can be captured in certain other staples . In either case, the clamping pressure or force applied to the tissue by the staples may vary, for example, from staple to staple, or between staples on one end of a row of staples and staples on the other end of a row of staples. In some cases, the gap between the anvil and the cartridge deck can be controlled such that the staples exert some minimum clamping pressure within each staple. In some such cases, however, significant variation in clamping pressure within different staples may still exist. Surgical stapling instruments are disclosed in US Patent No. 7,380,696, issued June 3, 2008, the entire disclosure of which is incorporated herein by reference. An illustrative multi-stroke handle for a surgical stapling and severing instrument is modified in co-pending and commonly owned U.S. Patent Application No. 10/374,026 entitled "SURGICAL STAPLING INSTRUMENT INCORPORATING A MULTISTROKE FIRING POSITION INDICATOR AND RETRACTION MECHANISM." detailed description, the disclosure of this patent application is hereby incorporated by reference in its entirety. Other applications consistent with the present invention may incorporate single-shot triggering, such as that described in co-pending and commonly owned U.S. Patent Application No. The disclosure of the application is hereby incorporated by reference in its entirety.

As described herein, a staple cartridge may include means for compensating for the thickness of tissue captured within staples deployed from the staple cartridge. 14, a staple cartridge, such as staple cartridge 10000, for example, can include a rigid first portion, such as support portion 10010, and a compressible second portion, such as tissue thickness compensator 10020. Referring first to FIG. 16 , the support portion 10010 can include a cartridge body, a top deck surface 10011 and a plurality of staple cavities 10012 . Therein, each staple cavity 10012 can define an opening in the deck surface 10011, similar to that described above. Staples 10030 can be removably positioned within each staple cavity 10012, for example. For example, each staple 10030 can include a base 10031 and one or more deformable legs 10032 extending from the base 10031 . Prior to the staples 10030 being deployed, as also described in more detail below, the bases 10031 of the staples 10030 can be supported by staple drivers positioned within the support portion 10010 and, at the same time, the legs 10032 of the staples 10030 can be at least partially received within the staple cavities 10012 . The staples 10030 can be deployed between an unfired position and a fired position such that the legs 10032 move through the tissue thickness compensator 10020, penetrate the top surface of the tissue thickness compensator 10020, penetrate the tissue T, and contact is positioned at the staple cartridge. 10000 opposite the anvil. When the legs 10032 are deformed against the anvil, the legs 10032 of each staple 10030 can capture a portion of the tissue thickness compensator 10020 and a portion of the tissue T within each staple 10030 and apply a compressive force to the tissue. Further to the above, the legs 10032 of each staple 10030 can be deformed downwardly toward the base 10031 of the staple to form a staple entrapment region 10039 where the tissue T and tissue thickness compensator 10020 can be captured. In various circumstances, a staple entrapment region 10039 can be defined between the inner surface of the deformed leg 10032 and the inner surface of the base 10031 . The size of the staple entrapment area may depend on several factors, such as the length of the legs, the diameter of the legs, the width of the base, and/or the degree of deformation of the legs, for example.

Heretofore, surgeons often needed to select the proper staple with the proper staple height for the tissue being stapled. For example, a surgeon may select tall staples for use with thick tissue and low staples for use with thin tissue. In some instances, however, the tissue being stapled does not have a consistent thickness and, therefore, some staples fail to achieve the desired firing configuration. For example, Figure 48 shows tall staples used in thin tissue. Referring now to FIG. 49, when a tissue thickness compensator, such as tissue thickness compensator 10020, is used, for example, with thin tissue, larger staples, for example, can be shaped into a desired firing configuration.

Due to the compressibility of the tissue thickness compensator, the tissue thickness compensator can compensate for the thickness of the tissue captured within each staple. More specifically, referring now to FIGS. 43 and 44 , a tissue thickness compensator, such as tissue thickness compensator 10020 , can occupy the staple entrapment of each staple 10030 , for example, depending on the thickness and/or type of tissue received within staple entrapment region 10039 . Larger and/or smaller portions of area 10039. For example, where thicker tissue T is captured within the staples 10030, the tissue thickness compensator 10020 can occupy a greater portion of the staple entrapment area 10039 if thinner tissue T is captured within the staples 10030. Accordingly, the tissue thickness compensator 10020 may occupy a smaller portion of the staple entrapment area 10039 if thicker tissue T is captured within the staple 10030 than if thinner tissue T is captured within the staple 10030 . In this manner, the tissue thickness compensator can compensate for thinner tissue and/or thicker tissue and ensure that compressive forces are applied to the tissue regardless, or at least substantially regardless, of the thickness of the tissue captured within the staples. In addition to the above, the tissue thickness compensator 10020 can compensate for different types or different rates of compression of tissue captured within different staples 10030 . Referring now to FIG. 44, a tissue thickness compensator 10020 can apply a compressive force to vascular tissue T, which can include a blood vessel V, and thus restrict blood flow through the less compressible blood vessel V, but still apply a desired compressive pressure to the surrounding Organization T. In various circumstances, further to the above, the tissue thickness compensator 10020 can also compensate for deformed staples. Referring to Fig. 45, deformation of various staples 10030 can result in larger staple entrapment regions 10039 defined within such staples. Due to the resiliency of the tissue thickness compensator 10020, referring now to FIG. 46, the tissue thickness compensator 10020 positioned within the deformed staple 10030 can still Apply sufficient compressive force to the tissue. In various instances, the tissue thickness compensator 10020 intermediate adjacent staples 10030 can be biased against the tissue T by suitably shaped staples 10030 around the deformed staples 10030 and thus apply compressive pressure, for example, around and/or Tissue captured within deformed staples 10030. In various cases, the tissue thickness compensator can compensate for different tissue densities that can result, for example, from calcifications, fibrous regions, and/or previously sutured or treated tissue.

According to the present invention, a fixed or unchangeable tissue gap can be defined between the support portion and the anvil, thereby deforming the staple to a predetermined height regardless of the thickness of the tissue captured within the staple. When a tissue thickness compensator is used in such situations, the tissue thickness compensator can accommodate the tissue captured between the anvil and the support portion of the cartridge, and due to the resiliency of the tissue thickness compensator, the tissue thickness compensator can hold the additional A compressive force is applied to the tissue. Referring now to FIGS. 50-55, the staples 10030 have been formed to a predefined height H. Referring now to FIGS. Referring to FIG. 50 , the tissue thickness compensator is not used and tissue T occupies the entire staple entrapment area 10039 . Referring to FIG. 57 , a portion of the tissue thickness compensator 10020 has been captured within the staples 10030 , has compressed the tissue T, and has occupied at least a portion of the staple entrapment region 10039 . Referring now to FIG. 52 , thin tissue T has been captured within staples 10030 . In this embodiment, the compressed tissue T has a height of about 2/9H, and the compressed tissue thickness compensator 10020 has a height of, for example, about 7/9H. Referring now to FIG. 53 , tissue T having an intermediate thickness has been captured within staples 10030 . In this embodiment, the compressed tissue T has a height of about 4/9H, and the compressed tissue thickness compensator 10020 has a height of, for example, about 5/9H. Referring now to FIG. 54 , tissue T having an intermediate thickness has been captured within staples 10030 . In this embodiment, the compressed tissue T has a height of about 2/3H, and the compressed tissue thickness compensator 10020 has a height of, for example, about 1/3H. Referring now to FIG. 53 , thick tissue T has been captured within staples 10030 . In this embodiment, the compressed tissue T has a height of about 8/9H, and the compressed tissue thickness compensator 10020 has a height of, for example, about 1/9H. In various cases, the tissue thickness compensator can comprise a compressed height comprising, for example, about 10% staple entrapment height, about 20% staple entrapment height, about 30% staple entrapment height, about 40% staple entrapment height Staple retention height, approximately 50% staple retention height, approximately 60% staple retention height, approximately 70% staple retention height, approximately 80% staple retention height, and/or approximately 90% staple retention height.

Staples 10030 can comprise any suitable unformed height. Staples 10030 can include, for example, an unformed height of between about 2 mm and about 4.8 mm. The staples 10030 can include, for example, an unformed height of about 2.0 mm, about 2.5 mm, about 3.0 mm, about 3.4 mm, about 3.5 mm, about 3.8 mm, about 4.0 mm, about 4.1 mm, and/or about 4.8 mm. The deformable height H of the staples may be determined by the distance between the platform surface 10011 of the support portion 10010 and the opposing anvil. The distance between the platform surface 10011 and the tissue-contacting surface of the anvil can be, for example, about 0.097". The height H can also be determined by the depth of the forming pocket defined in the anvil. The forming pocket can, for example, have a Optionally, as described in more detail below, the staple cartridge 10000 can also include staple drivers that can lift the staples 10030 toward the anvil and lift or "overdrive" the staples onto the deck surface 10011 In this case, the formed height H of the staples 10030 can also be determined by the distance by which the staples 10030 are overdriven. For example, the staples 10030 can be overdriven, for example, by approximately .028", and can result in the staples 10030 being formed, for example, by approximately 0.189" height. The staples 10030 can be shaped, for example, to a height of about 0.8mm, about 1.0mm, about 1.5mm, about 1.8mm, about 2.0mm, and/or about 2.25mm. The staples can be shaped, for example, between about A height between 2.25mm and approximately 3.0mm. Further described above, the height of the staple entrapment region of the staple may be determined by the formed height of the staple and the width and diameter of the wire comprising the staple. The staple entrapment region 10039 of the staple 10030 The height may comprise the formed height H of the staple minus the two diameter widths of the wire. The staple wire may comprise, for example, a diameter of approximately 0.0089". The staple wire can comprise, for example, a diameter between about 0.0069" and about 0.0119". For example, the formed height H of the staples 10030 can be about 0.189", and the staple wire diameter can be about 0.0089", resulting in a staple retention height of about 0.171", for example.

Further to the above, the tissue thickness compensator may comprise an uncompressed or pre-deployed height and be deformable to one of a plurality of compressed heights. The tissue thickness compensator can include, for example, an uncompressed height of about 0.125". The tissue thickness compensator can include, for example, an uncompressed height of greater than or equal to about 0.080". The tissue thickness compensator can include an uncompressed or pre-deployed height that is greater than the unfired height of the staples. The uncompressed or pre-deployed height of the tissue thickness compensator may be about 10% higher, about 20% higher, about 30% higher, about 40% higher, about 50% higher, about 60% higher, for example, than the unfired height of the staples. About 70% higher, about 80% higher, about 90% higher, and/or about 100% higher. The uncompressed or pre-deployed height of the tissue thickness compensator may be, for example, up to about 100% higher than the unfired height of the staples. The uncompressed or pre-deployed height of the tissue thickness compensator may be greater than, for example, more than 100% of the unfired height of the staples. The tissue thickness compensator can include an uncompressed height equal to the unfired height of the staples. The tissue thickness compensator can include an uncompressed height that is less than the unfired height of the staples. The uncompressed or pre-deployed height of the tissue thickness compensator may be, for example, about 10%, about 20% lower, about 30% lower, about 40% lower, about 50% lower, about 60% lower, or about 60% lower than the unfired height of the staples. About 70% lower, about 80% lower, and/or about 90% lower. The compressible second portion may include an uncompressed height that is higher than the uncompressed height of the tissue T being stapled. The tissue thickness compensator may include an uncompressed height equal to the uncompressed height of the tissue T being stapled. The tissue thickness compensator may include an uncompressed height that is lower than the uncompressed height of the tissue T being stapled.

As noted above, the tissue thickness compensator can be compressed within a plurality of formed staples regardless of whether thick or thin tissue is captured within the staples. For example, the staples within a staple line or row can be deformed such that the staple entrapment region of each staple includes a height of, for example, about 2.0 mm into which the tissue T and tissue thickness compensator can be compressed. In some cases, the tissue T can include a compressed height of about 1.75 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 0.25 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 1.50 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 0.50 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 1.25 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 0.75 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 1.0 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 1.0 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 0.75 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 1.25 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 1.50 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 0.50 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm. In some cases, the tissue T can include a compressed height of about 0.25 mm in the staple entrapment region, and the tissue thickness compensator can include a compressed height of about 1.75 mm in the staple entrapment region, resulting in a total of, for example, about 2.0 mm. The height of the nail entrapment zone in mm.

Further to the above, the tissue thickness compensator may comprise an uncompressed height that is less than the fired height of the staples. The tissue thickness compensator can include an uncompressed height equal to the fired height of the staples. The tissue thickness compensator can include an uncompressed height above the fired height of the staples. For example, the uncompressed height of the tissue thickness compensator can comprise, for example, a thickness of about 110% of the height of the formed staples, about 120% of the height of the formed staples, about 130% of the height of the formed staples, about 140% of the height of the formed staples , about 150% of the height of the formed staples, about 160% of the height of the formed staples, about 170% of the height of the formed staples, about 180% of the height of the formed staples, about 190% of the height of the formed staples, and/or about 200% of the height of the formed staples %. The tissue thickness compensator can include an uncompressed height that is more than twice the fired height of the staples. The tissue thickness compensator can include a compressed height that is, for example, about 85% to about 150% of the height of the formed staples. Optionally, as described above, the tissue thickness compensator can be compressed between an uncompressed thickness and a compressed thickness. The compressed thickness of the tissue thickness compensator can be, for example, about 10% of its uncompressed thickness, about 20% of its uncompressed thickness, about 30% of its uncompressed thickness, about 40% of its uncompressed thickness, about about 50% of its uncompressed thickness, about 60% of its uncompressed thickness, about 70% of its uncompressed thickness, about 80% of its uncompressed thickness, and/or about 90% of its uncompressed thickness. The uncompressed thickness of the tissue thickness compensator can be, for example, about two times, about ten times, about fifty times, and/or about one hundred times thicker than its compressed thickness. The compressed thickness of the tissue thickness compensator may be between about 60% and about 99% of its uncompressed thickness. The uncompressed thickness of the tissue thickness compensator can be at least 50% thicker than its compressed thickness. The uncompressed thickness of the tissue thickness compensator may be up to one hundred times thicker than its compressed thickness. The compressible second portion may be elastic, or at least partially elastic, and may bias the tissue T against the deformed legs of the staples. For example, the compressible second portion can elastically expand between the tissue T and the base of the staple so as to push the tissue T against the legs of the staple. As described in further detail below, the tissue thickness compensator can be positioned intermediate the tissue T and the deformed staple legs. In each case, due to the above, the tissue thickness compensator is able to eliminate any gaps in the staple entrapment area.

The tissue thickness compensator may comprise a material characterized by one or more of the following properties: e.g., biocompatibility, bioabsorbability, bioresorbability, biodurability, biodegradability, compressibility, fluid absorption Sexuality, swelling, self-expansion, biological activity, drug, drug activity, anti-adhesion, hemostatic, antibacterial, antimicrobial, antiviral, nutritional, adhesive, permeability, hydrophilic, and/or hydrophobicity. In accordance with the present invention, a surgical instrument including an anvil and a staple cartridge may include a tissue thickness compensator associated with the anvil and/or the staple cartridge, the tissue thickness compensator comprising at least one of the following materials: a hemostatic agent (e.g., fibrin and thrombin), antibiotics (eg, doxycpl), and drugs (eg, matrix metalloproteinases (MMPs)).

The tissue thickness compensator may comprise synthetic and/or non-synthetic materials. The tissue thickness compensator may comprise a polymer composition comprising one or more synthetic polymers and/or one or more non-synthetic polymers. Synthetic polymers may include synthetic absorbable polymers and/or synthetic non-absorbable polymers. A polymer composition can include, for example, a biocompatible foam. Biocompatible foams may include, for example, porous open-cell foams and/or porous closed-cell foams. Biocompatible foams may have a uniform cell morphology or may have a gradient cell morphology (ie, small cells that gradually increase in size to larger cells throughout the thickness of the foam in one direction). The polymer composition may include porous scaffolds, porous matrices, gel matrices, hydrogel matrices, solution matrices, filamentous matrices, tubular matrices, composite matrices, membrane matrices, biostable polymers, and biodegradable polymers. One or more, and combinations thereof. For example, a tissue thickness compensator may comprise a foam reinforced by a filamentary matrix, or may comprise a foam with an additional layer of hydrogel that expands in the presence of bodily fluids to provide further compression on the tissue. According to the invention, the tissue thickness compensator may also consist of a material and/or a coating on the second or third layer which expands in the presence of bodily fluids to provide further compression on the tissue. Such layers may be hydrogels, which may be of synthetic and/or natural origin, and which may, for example, be biodurable and/or biodegradable. The tissue thickness compensator may comprise microgels or nanogels. Hydrogels may include microgels and/or nanogels derived from carbohydrates. The tissue thickness compensator may be reinforced with fibrous nonwoven or fibrous mesh type elements that provide additional flexibility, stiffness, and/or strength. According to the invention, the tissue thickness compensator has a porous morphology exhibiting a gradient structure, eg small pores on one surface and larger pores on the other surface. Such morphology is more ideal for tissue growth or hemostatic behavior. Furthermore, gradients can also be combined with varying bioabsorption profiles. A short-term absorption profile may be preferred to address hemostasis, while a long-term absorption profile may address better tissue healing without leakage.

Examples of non-synthetic materials include, but are not limited to, lyophilized polysaccharides, glycoproteins, bovine pericardium, collagen, gelatin, fibrin, fibrinogen, elastin, proteoglycans, keratin, albumin, hydroxyethyl cellulose cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitin, chitosan, casein, alginate and their combination.

Examples of synthetic absorbable materials include, but are not limited to, poly(lactic acid) (PLA), poly(L-lactic acid) (PLLA), polycaprolactone (PCL), polyglycolic acid (PGA), poly(trimethylene carbonate ) (TMC), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), copolymers of glycolide and ε-caprolactone (PGCL), glycolide and trimethylene Copolymers of carbonates, poly(glyceryl sebacate) (PGS), poly(dioxanone) (PDS), polyesters, poly(orthoesters), polyoxoesters, polyethers Esters, polycarbonates, polyesteramides, polyanhydrides, polysaccharides, poly(ester-amides), tyrosine-based polyarylates, polyamines, tyrosine-based polyimidocarbonates, tyrosine-based polycarbonates , poly(D,L-lactide-urethane), poly(hydroxybutyrate), poly(B-hydroxybutyrate), poly(E-caprolactone), polyethylene glycol (PEG ), poly[bis(carboxyphenoxy)phosphazene], poly(amino acid), pseudopoly(amino acid), absorbable polyurethane, poly(phosphazine), polyphosphazene, polyoxyalkylene, polyacrylamide, polyformazine hydroxyethyl acrylate, polyvinylpyrrolidone, polyvinyl alcohol, poly(caprolactone), polyacrylic acid, polyacetate, polypropylene, aliphatic polyester, glycerin, copoly(ether-ester), polyalkylene oxalate glycol esters, polyamides, poly(iminocarbonates), polyalkylene oxalates, and combinations thereof. The polyester may be selected from polylactide, polyglycolide, trimethylene carbonate, polydioxanone, polycaprolactone, polybutenyl ester, and combinations thereof.

Synthetic absorbable polymers can include, for example, 90/10 poly(glycolide-L-lactide) copolymer commercially available under the trade name VICRYL (polyglactic 910) from Ethicon, Inc., available under the trade name DEXON from American Polyglycolide commercially available from Cyanamid Co., polydioxanone commercially available under the trade name PDS from Ethicon, Inc., poly(glycolide) commercially available under the trade name MAXON from American Cyanamid Co. Ester-trimethylene carbonate) random block copolymer, one of the 75/25 poly(glycolide-ε-caprolactone-poliglecaprolactone 25) copolymers commercially available from Ethicon Corporation under the trade name MONOCRYL or more.

Synthetic nonabsorbable materials include, but are not limited to, polyurethane, polypropylene (PP), polyethylene (PE), polycarbonate, polyamides, such as nylon, polyvinyl chloride (PVC), polymethylmethacrylate (PMMA) ), polystyrene (PS), polyester, polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PTFCE), polyvinyl fluoride (PVF), fluorinated ethylene propylene (FEP ), polyacetal, polysulfone, silicon, and combinations thereof. Synthetic non-absorbable polymers may include, but are not limited to, elastomeric foams and cellular elastomers such as silicone, polyisoprene, and rubber. Synthetic polymers can include expanded polytetrafluoroethylene (ePTFE), commercially available under the trade name GORE-TEX Soft Tissue Mesh from W.L. Gore & Associates, Inc., and co-polyetheresters commercially available under the trade name NASOPORE from Polyganics Urethane foam.

The polymer composition may include, for example, a polymer composition of about 50% to about 90% by weight of PLLA, and a polymer composition of about 50% to about 10% by weight of PCL. The polymer composition may include, for example, about 70% by weight of PLLA, and about 30% by weight of PCL. The polymer composition may include, for example, a polymer composition of about 55% to about 85% by weight of PGA, and a polymer composition of 15% to 45% by weight of PCL. The polymer composition may include, for example, about 65% by weight of PGA, and about 35% by weight of PCL. The polymer composition may include, for example, a polymer composition of about 90% to about 95% by weight of PGA, and a polymer composition of about 5% to about 10% by weight of PLA.

Synthetic absorbable polymers may include bioabsorbable, biocompatible elastomeric copolymers. Suitable bioabsorbable, biocompatible elastomeric copolymers include, but are not limited to, copolymers of ε-caprolactone and glycolide (the molar ratio of ε-caprolactone to glycolide is preferably about 30 :70 to about 70:30, preferably 35:65 to about 65:35, more preferably 45:55 to 35:65); ε-caprolactone and lactide (including L-lactide, Elastomeric copolymers of D-lactide, their blends, or lactic acid copolymers) (the molar ratio of ε-caprolactone to lactide is preferably from about 35:65 to about 65:35, and more preferably 45:55 to 30:70); for dioxanone (1,4-dioxan-2-one) and lactide (including L-lactide, D-lactide ester and lactic acid) (the molar ratio of p-dioxanone to lactide is preferably from about 40:60 to about 60:40); ε-caprolactone and p-dioxanone Elastomeric copolymers of ketones (e-caprolactone to p-dioxanone molar ratio preferably from about 30:70 to about 70:30); p-dioxanone and trimethylene carbonate (The molar ratio of dioxanone to trimethylene carbonate is preferably from about 30:70 to about 70:30); Elastomeric copolymers of trimethylene carbonate and glycolide ( The molar ratio of trimethylene carbonate to glycolide is preferably from about 30:70 to about 70:30); elastomeric copolymers of trimethylene carbonate and lactide, including L-lactide, D-lactide lactides, blends thereof, or lactic acid copolymers (the molar ratio of trimethylene carbonate to lactide is preferably from about 30:70 to about 70:30); and blends thereof. The elastomeric copolymer may be a copolymer of glycolide and ε-caprolactone. Alternatively, the elastomeric copolymer is lactide and

Copolymers of ε-caprolactone. The disclosures of U.S. Patent 5,468,253, issued November 21, 1995, entitled "ELASTOMERIC MEDICALDEVICE," and U.S. Patent 6,325,810, issued December 4, 2001, entitled "FOAM BUTTRESS FORSTAPLING APPARATUS" are each incorporated by reference in their entirety. way incorporated into this article.

The tissue thickness compensator may contain an emulsifier. Examples of emulsifiers may include, but are not limited to, water-soluble polymers such as polyvinyl alcohol (PVA), vinylpyrrolidone (PVP), polyethylene glycol (PEG), polypropylene glycol (PPG), PLURONICS, TWEENS, polysaccharides and combinations thereof.

The tissue thickness compensator may contain a surfactant.

Examples of surfactants may include, but are not limited to, polyacrylic acid, methylase, methylcellulose, ethylcellulose, propylcellulose, hydroxyethylcellulose, carboxymethylcellulose, polyoxyethylene cetyl Alkyl ether, polyoxyethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octylphenyl ether, polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene hard Fatty ethers, polyoxyethylene nonylphenyl ethers, dialkylphenoxypoly(ethyleneoxy)ethanols, and poloxamers.

The polymer composition may include a pharmaceutically active agent. The polymer composition releases a therapeutically effective amount of a pharmaceutically active agent. The pharmaceutically active agent can be released when the polymer composition is desorbed or absorbed. The pharmaceutically active agent can be released into a fluid (eg, blood) flowing over or through the polymer composition. Examples of pharmaceutically active agents may include, but are not limited to, hemostatic agents and drugs such as fibrin, thrombin, and oxidized regenerated cellulose (ORC); anti-inflammatory agent drugs such as diclofenac, aspirin, naproxen, sulindac, and hydrogenated Cortisone; antibiotic and antimicrobial drugs or antimicrobial agents such as triclosan, ionic silver, ampicillin, gentamicin, polymyxin B, chloramphenicol; and anticancer agents such as cisplatin, silk Split mycin, doxorubicin.

The polymer composition may include a hemostatic material. The tissue thickness compensator may comprise a hemostatic material including poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(caprolactone), poly(dioxanone), polyoxy ene, copoly(ether-ester), collagen, gelatin, thrombin, fibrin, fibrinogen, fibronectin, elastin, albumin, hemoglobin, ovalbumin, polysaccharide, hyaluronic acid, chondroitin sulfate, Hydroxyethyl starch, hydroxyethyl cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitin, chitosan, agarose, maltose, maltose Dextrin, alginate, coagulation factor, methacrylate, polyurethane, acrylate, platelet agonist, vasoconstrictor, alum, calcium, RGD peptide, protein, protamine sulfate, ε-aminocaproic acid, sulfuric acid Iron, basic ferric sulfate, ferric chloride, zinc, zinc chloride, aluminum chloride, aluminum sulfate, aluminum acetate, permanganate, tannic acid, bone wax, polyethylene glycol, fucoidan and their The combination. The tissue thickness compensator may be characterized by hemostatic properties.

The polymer composition of the tissue thickness compensator is characterized, for example, by percent porosity, pore size, and/or hardness. The polymer composition can have a percent porosity of, for example, from about 30% to about 99% by volume. The polymer composition can have a percent porosity of, for example, from about 60% to about 98% by volume. The polymer composition can have a percent porosity of, for example, from about 85% to about 97% by volume. The polymer composition may include, for example, about 70% by weight of PLLA and about 30% by weight of PCL, and may include, for example, about 90% by volume of porosity. Thus, for example, the polymer composition will comprise approximately 10% by volume of copolymer. The polymer composition may include, for example, about 65% by weight of PGA and about 35% by weight of PCL, and may have a percent porosity, for example, of about 93% to about 95% by volume. The polymer composition may include a porosity greater than 85% by volume. The polymer composition can have a pore size, for example, from about 5 microns to about 2000 microns. The polymer composition can have, for example, a pore size between about 10 microns and about 100 microns. For example, the polymer composition may include, for example, a copolymer of PGA and PCL. The polymer composition can have, for example, a pore size between about 100 microns and about 1000 microns. For example, the polymer composition may include, for example, a copolymer of PLLA and PCL.

According to certain aspects, the hardness of the polymer composition can be expressed in Shore hardness. The Shore hardness can be defined as the resistance to permanent dents of a material such as determined by a Shore durometer. To evaluate the durometer value for a given material, pressure is applied to the material with a durometer foot in accordance with ASTM procedure D2240-00 entitled "Standard Test Method for Rubber Property—Durometer Hardness," the entirety of which is incorporated by reference herein. into this article. The durometer foot may be applied to the material for a sufficient period of time, such as 15 seconds, for example, where the reading is taken from an appropriate scale. Depending on the type of scale used, a reading of 0 is obtained when the indenter foot has completely penetrated the material, and a reading of 100 is obtained when the material has not been penetrated. This reading is dimensionless. Durometers can be determined, for example, according to ASTM D2240-00 using any suitable scale (eg, Type A and/or Type OO scales). The polymer composition of the tissue thickness compensator may have a Shore A hardness value of about 4A to about 16A, for example in the Shore OO range of about 45OO to about 65OO. For example, the polymer composition may include, for example, a PLLA/PCL copolymer or a PGA/PCL copolymer. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of less than 15A. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of less than 10A. The polymer composition of the tissue thickness compensator may have a Shore A hardness value of less than 5A. The polymeric material may have a Shore OO composition value of, for example, from about 3500 to about 7500.

A polymer composition may have at least two of the above-identified properties. A polymer composition may have at least three of the above-identified properties. The polymer composition may have, for example, a porosity by volume of 85% to 97%, a pore size of 5 microns to 2000 microns, and a Shore A hardness value of 4A to 16A and a Shore OO hardness value of 4500 to 6500. The polymer composition may comprise a polymer composition of 70% by weight of PLLA and a polymer composition of 30% by weight of PCL; the polymer composition has, for example, a porosity of 90% by volume, 100 Pore sizes from microns to 1000 microns, and Shore A hardness values from 4A to 16A and Shore OO hardness values from 45OO to 65OO. The polymer composition may comprise a polymer composition of 65% by weight of PGA and 35% by weight of PCL; the polymer composition has, for example, 93% to 95% by volume of porosity Rate, pore size from 10 microns to 100 microns, and Shore A hardness values from 4A to 16A and Shore OO hardness values from 45OO to 65OO.

The thickness tissue compensator can include expanded material. As noted above, the tissue thickness compensator may comprise a compressed material that expands when uncompressed or when deployed. The tissue thickness compensator may comprise a self-expanding material formed in situ. The tissue thickness compensator may comprise at least one precursor selected to spontaneously cross-link upon contact with at least one of other precursors, water, and/or bodily fluids. According to the present invention, a first precursor may be contacted with one or more other precursors to form an expandable and/or swellable tissue thickness compensator. The tissue thickness compensator may comprise a fluid-swellable composition, eg, a water-swellable composition. The tissue thickness compensator may comprise an aqueous gel.

The tissue thickness compensator may comprise a biodegradable foam having an encapsulation including dry hydrogel particles or granules embedded therein. Without being bound by any particular theory, the enclosure in the foam may be formed by contacting an aqueous solution of a hydrogel precursor and an organic solution of a biocompatible material to form a foam. Aqueous and organic solutions can form micelles. Aqueous and organic solutions can be dried to encapsulate dried hydrogel particles or granules within the foam. For example, hydrogel precursors such as hydrophilic polymers can be dissolved in water to form a dispersion of micelles. The aqueous solution may be contacted with an organic solution of dioxane comprising poly(glycolic acid) and polycaprolactone. Aqueous and organic solutions can be lyophilized to form biodegradable foams having dried hydrogel particles or granules dispersed therein. Without being bound by any particular theory, it is believed that the micelles form capsules having dry hydrogel particles or granules dispersed within the foam structure. The package can be ruptured and the dry hydrogel particle or granules can come into contact with a fluid (such as bodily fluid) and expand.

Optionally, the tissue thickness compensator may include an initial thickness and an extended thickness, as described above. The initial thickness of the tissue thickness compensator can be, for example, about 0.001% of its expanded thickness, about 0.01% of its expanded thickness, about 0.1% of its expanded thickness, about 1% of its expanded thickness, about 10% of its expanded thickness, About 20% of its expanded thickness, about 30% of its expanded thickness, about 40% of its expanded thickness, about 50% of its expanded thickness, about 60% of its expanded thickness, about 70% of its expanded thickness, its expanded about 80% of its thickness, and/or about 90% of its extended thickness. The expanded thickness of the tissue thickness compensator can be, for example, about 2 times, about 5 times, about 10 times, about 50 times, about 100 times, about 200 times, about 300 times, about 400 times, about 500 times, about 500 times, About 600 times, about 700 times, about 800 times, about 900 times, and/or about 1000 times. The initial thickness of the tissue thickness compensator can be up to 1% of its expanded thickness, up to 5% of its expanded thickness, up to 10% of its expanded thickness, and up to 50% of its expanded thickness. The expanded thickness of the tissue thickness compensator can be at least 50% thicker, at least 100% thicker, at least 300% thicker, and at least 500% thicker than its original thickness. As noted above, in various circumstances, the tissue thickness compensator can eliminate any gaps in the staple entrapment area.

As noted above, the tissue thickness compensator may comprise a hydrogel. Hydrogels may include homopolymer hydrogels, copolymer hydrogels, multipolymer hydrogels, interpenetrating polymer hydrogels, and combinations thereof. Hydrogels can include microgels, nanogels, and combinations thereof. Hydrogels can generally include a network of hydrophilic polymers capable of absorbing and/or retaining fluids. Hydrogels can include non-crosslinked hydrogels, crosslinked hydrogels, and combinations thereof. Hydrogels may include chemical cross-linkers, physical cross-linkers, hydrophobic segments and/or water-insoluble segments. Hydrogels can be chemically crosslinked by polymerization, small molecule crosslinking, and/or polymer-polymer crosslinking. Hydrogels can be physically crosslinked through ionic interactions, hydrophobic interactions, hydrogen bonding interactions, stereocomplexation, and/or supramolecular chemistry. Hydrogels may be substantially insoluble due to cross-linking agents, hydrophobic segments, and/or water-insoluble segments, but expandable and/or swellable due to absorbing and/or retaining fluid. Precursors can be cross-linked with endogenous materials and/or tissues.

Hydrogels may include environmentally sensitive hydrogels (ESH). ESH can include materials that have fluid-swellability properties that are related to environmental conditions. Environmental conditions may include, but are not limited to, physical, biological, and/or chemical conditions at the surgical site. For example, hydrogels can swell or shrink in response to temperature, pH, electric fields, ionic strength, enzymatic and/or chemical reactions, electrical and/or magnetic stimuli, and other physiological and environmental variables. ESH can include multifunctional acrylates, hydroxyethyl methacrylate (HEMA), elastomeric acrylates, and related monomers.

A tissue thickness compensator comprising a hydrogel may comprise at least one of the non-synthetic and synthetic materials described above. Hydrogels may include synthetic hydrogels and/or non-synthetic hydrogels. The tissue thickness compensator can include multiple layers. Multiple layers may include porous layers and/or non-porous layers. For example, a tissue thickness compensator can include a non-porous layer and a porous layer. As another example, the tissue thickness compensator can include a porous layer intermediate the first non-porous layer and the second non-porous layer. As another example, the tissue thickness compensator may include a non-porous layer intermediate the first porous layer and the second porous layer. The non-porous layer and the porous layer can be positioned in any order relative to the surface of the staple cartridge and/or anvil.

Examples of non-synthetic materials may include, but are not limited to, albumin, alginate, carbohydrates, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fiber Proteinogen, gelatin, heparin, hyaluronic acid, keratin, protein, serum and starch. Cellulose may include hydroxyethyl cellulose, oxidized cellulose, oxidized regenerated cellulose (ORC), hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, and combinations thereof. Collagen may include bovine pericardium. Carbohydrates may include polysaccharides, such as lyophilized polysaccharides. Proteins may include glycoproteins, proteoglycans, or combinations thereof.

Examples of synthetic materials may include, but are not limited to, poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(phosphazines), polyesters, polyethylene glycols, polyethylene oxides, polycyclic Ethylene oxide-polypropylene oxide copolymer, polyethylene oxide, polyoxyalkylene, polyacrylamide, polyhydroxyethyl methacrylate, poly(vinylpyrrolidone), polyvinyl alcohol, poly(caprolactone), Poly(dioxanone), polyacrylic acid, polyacetate, polypropylene, aliphatic polyester, glycerin, poly(amino acid), copoly(ether-ester), polyalkylene oxalate, poly Amides, poly(iminocarbonates), polyoxyesters, polyorthoesters, polyphosphazenes, and combinations thereof. The non-synthetic materials described above can be prepared synthetically using conventional methods, such as synthetic hyaluronic acid.

Hydrogels can be made from one or more hydrogel precursors. Precursors may include monomers and/or macromers. The hydrogel precursor may include electrophile functional groups and/or nucleophile electrophile functional groups. In general, electrophiles can react with nucleophiles to form chemical bonds. The term "functional group" as used herein refers to electrophilic or nucleophilic groups capable of reacting with each other to form chemical bonds. Examples of electrophilic functional groups may include, but are not limited to, N-hydroxysuccinimide ("NHS"), sulfosuccinimide, carbonyldiimidazole, sulfonyl chloride, aryl halide, sulfosuccinate, N-hydroxy Succinimidyl esters, succinimidyl esters such as succinimidyl succinate and/or succinimidyl propionate, isocyanates, thiocyanates, carbodiimides, benzotriazoles Carbonates, epoxies, aldehydes, maleimides, imidates, combinations thereof, and the like. Electrophilic functional groups may include succinimidyl esters. Examples of nucleophilic functional groups may include, but are not limited to, _-NH2 , -SH, -OH, -PH2, and -CO-NH _{- NH2} .

Hydrogels can be formed from a single precursor or from multiple precursors. A hydrogel can be formed from a first precursor and a second precursor. The first hydrogel precursor and the second hydrogel precursor can form a hydrogel in situ or in vivo upon contact. Hydrogel precursors may generally refer to polymers, functional groups, macromolecules, small molecules, and/or crosslinkers capable of participating in reactions to form hydrogels. Precursors may include, for example, homogeneous solutions, heterogeneous or phase-separated solutions in suitable solvents, such as water or buffers. The pH of the buffer may be, for example, from about 8 to about 12, such as from about 8.2 to about 9. Examples of buffers may include, but are not limited to, borate buffers. The precursor may be in an emulsion. According to the present invention, a first precursor can be reacted with a second precursor to form a hydrogel. The first precursor may spontaneously crosslink upon contact with the second precursor. According to the invention, a first set of electrophilic functional groups on a first precursor can react with a second set of nucleophilic functional groups on a second precursor. Functional groups can react with each other to form covalent bonds when the precursors are mixed in an environment that allows the reaction (eg, as related to pH, temperature, and/or solvent). Precursors may become crosslinked when at least some of the precursors react with more than one other precursor.

The tissue thickness compensator may comprise at least one monomer selected from the group consisting of potassium 3-sulfopropylacrylate ("KSPA"), sodium acrylate ("NaA"), N-(tris(hydroxymethyl)methyl) ) acrylamide ("triacryloyl") and 2-acrylamide-2-methyl-1-propanesulfonic acid (AMPS). The tissue thickness compensator may comprise a copolymer comprising two or more monomers selected from KSPA, NaA, triacryloyl, AMPS. The tissue thickness compensator may comprise homopolymers derived from KSPA, NaA, triacryloyl, AMPS. The tissue thickness compensator may include a hydrophilic modifying monomer copolymerizable therewith. The hydrophilic modifying monomer may include methyl methacrylate, butyl acrylate, cyclohexyl acrylate, styrene, styrene sulfonic acid.

The tissue thickness compensator may include a cross-linking agent. Cross-linking agents may include low molecular weight di- or polyethylene cross-linking agents such as ethylene glycol diacrylate or dimethacrylate, di-, tri- or tetraethylene-ethylene glycol diacrylate or dimethacrylate, Allyl (meth)acrylate, C ₂ -C ₈ -alkylene diacrylate or dimethacrylate, divinyl ether, divinylsulfone, di- and trivinylbenzene, trimethylolpropanetri Acrylate or Trimethacrylate, Pentaerythritol Tetraacrylate or Tetramethacrylate, Bisphenol A Diacrylate or Dimethacrylate, Methylenebisacrylamide or Dimethacrylamide, Ethylenebisacrylamide or Ethylene Dimethacrylamide, Triallyl Phthalate, or Diallyl Phthalate. Crosslinkers may include N,N'-methylenebisacrylamide ("MBAA").

The tissue thickness compensator may comprise at least one of an acrylate and/or methacrylate functional hydrogel, a biocompatible photoinitiator, an alkyl-cyanoacrylate, an isocyanate functional macromer, optionally optionally including amine functional macromers, succinimidyl ester functional macromers, optionally including amine and/or mercapto functional macromers, epoxy functional macromers, optionally including amine functional Mixtures of macromers, proteins and/or peptides and aldehyde crosslinkers, Genipin and water soluble carbodiimides, anionic polysaccharides and polyvalent cations.

The tissue thickness compensator may include unsaturated organic acid monomers, acrylic substituted alcohols, and/or acrylamide. Tissue thickness compensators may include methacrylic acid, acrylic acid, glycerol acrylate, glycerol methacrylate, 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, 2-(dimethylaminoethyl)methacrylate acrylate, N-vinylpyrrolidone, methacrylamide and/or N,N-dimethylacrylamide poly(methacrylic acid).

The tissue thickness compensator may include reinforcing material. The reinforcing material may include at least one of the non-synthetic and synthetic materials described above. Reinforcing materials may include collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethyl cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, Carboxymethylcellulose, chitin, chitosan, alginate, poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(phospharazine), polyester, polyethylene glycol , polyoxyalkylene, polyacrylamide, polyhydroxyethylmethacrylate, polyvinylpyrrolidone, polyvinyl alcohol, poly(caprolactone), poly(dioxanone), polyacrylic acid, polyacetate, Polycaprolactone, polypropylene, aliphatic polyester, glycerin, poly(amino acid), copoly(ether-ester), polyalkylene oxalate, polyamide, poly(iminocarbonate), polyoxalate Alkyl glycol esters, polyoxyesters, polyorthoesters, polyphosphazenes, and combinations thereof.

The tissue thickness compensator may include a layer comprising a reinforcing material. The porous and/or non-porous layers of the tissue thickness compensator may include reinforcing materials. For example, a porous layer may include reinforcement material and a non-porous layer may not include reinforcement material. The reinforcement layer may include an inner layer intermediate the first non-porous layer and the second non-porous layer. The reinforcement layer may comprise the outer layer of the tissue thickness compensator. The reinforcement layer may comprise the outer surface of the tissue thickness compensator.

Reinforcing materials may include meshes, monofilaments, multifilament braids, fibers, mats, felts, granules and/or powders. Reinforcing material may be incorporated into the layers of the tissue thickness compensator. A reinforcing material may be incorporated into at least one of the non-porous layer and the porous layer. The mesh including the reinforcing material may be formed using conventional techniques such as knitting, weaving, weaving and/or knitting.

According to the invention, a plurality of reinforcing materials may be oriented in random directions and/or in a common direction. The common direction can be, for example, one of parallel to the staple line and perpendicular to the staple line. For example, monofilament and/or multifilament braids can be oriented in random directions and/or in a common direction. Monofilament and multifilament braids can be associated with non-porous and/or porous layers. The tissue thickness compensator may include a plurality of reinforcing fibers oriented in random directions within the non-porous layer. The tissue thickness compensator may include a plurality of reinforcing fibers oriented in a common direction within the non-porous layer.

Fibers can be formed into nonwoven materials such as mats and felts. The fibers may be of any suitable length, for example from 0.1mm to 100mm and 0.4mm to 50mm. Reinforcement materials can be ground into powders. The powder may have a particle size, for example, from 10 microns to 1 centimeter. Powder can be incorporated into the tissue thickness compensator.

The tissue thickness compensator can be formed in situ. Hydrogels can be formed in situ. Tissue thickness compensators can be formed in situ by covalent ionic and/or hydrophobic bonds. Physical (non-covalent) crosslinking can result from complexation, hydrogen bonding, desolvation, van der Waals interactions, ionic bonding, and combinations thereof. Chemical (covalent) crosslinking can be achieved by any of a variety of mechanisms: free radical polymerization, polycondensation, anionic or cationic polymerization, step-growth polymerization, electrophile-nucleophile reactions, and combinations thereof.

Optionally, in situ formation of the tissue thickness compensator may include reacting two or more precursors that are physically separated until contacted in situ and/or react to environmental conditions to react with each other to form Hydrogels. In situ polymerizable polymers can be prepared from precursors that can react to form polymers at the surgical site. The tissue thickness compensator can be formed by an in situ cross-linking reaction of the precursors. The precursor may include an initiator capable of initiating a polymerization reaction for formation of the in situ tissue thickness compensator. The tissue thickness compensator can include precursors that can be activated upon application to form a cross-linked hydrogel. Forming the tissue thickness compensator in situ may include exciting at least one precursor to form a chemical bond, thereby forming the tissue thickness compensator. Optionally, activation can be achieved by changes in physical, biological and/or chemical conditions at the surgical site, including but not limited to temperature, pH, electric field, ionic strength, enzymatic and/or chemical reactions, electrical and/or magnetic stimulation, and other physiological and environmental variables. The precursor can be exposed to the exterior of the body and introduced into the surgical site.

A tissue thickness compensator may include one or more enclosures or cells capable of storing at least one component therein. The enclosure is capable of storing a hydrogel precursor therein. For example, the enclosure can store two components therein. The enclosure is capable of storing therein a first hydrogel precursor and a second hydrogel precursor. The first enclosure is capable of storing therein a first hydrogel precursor and the second enclosure is capable of storing therein a second hydrogel precursor. As noted above, the package can be aligned, or at least substantially aligned, with the staple legs to pierce and/or otherwise rupture the package when the staple legs contact the package. The package may be compressed, crushed, collapsed and/or otherwise ruptured when the staples are deployed. Following rupture of the enclosure, the components stored therein may flow out of the enclosure. Components stored therein may contact other components, layers of the tissue thickness compensator and/or tissue. Other components may be from the same or different package, provided in layers of the tissue thickness compensator and/or applied to the surgical site by the clinician. As a result of the above, the components stored within the enclosure can provide expansion and/or swelling of the tissue thickness compensator.

A tissue thickness compensator may include a layer comprising an encapsulation. The enclosure may include voids, dimples, domes, tubes, and combinations thereof associated with the layers. The encapsulation may include voids in the layers. A layer may comprise two layers capable of being attached to each other, wherein an encapsulation may be defined between the two layers. The encapsulation may include domes on the surface of the layers. For example, at least a portion of the enclosure may be positioned within a dome extending upwardly from the layer. The encapsulation may include recesses formed in the layers. The first portion of the enclosure may include domes and the second portion of the enclosure may include dimples. The enclosure may include tubes embedded within layers. The tube may comprise non-synthetic and/or synthetic materials as described herein, such as PLA. The tissue thickness compensator may comprise a bioabsorbable foam, such as ORC, that includes a tube of PLA embedded therein, and the tube may encapsulate, for example, a hydrogel. A package may include discrete units that are not connected to each other. One or more of the enclosures may be in fluid communication with each other via one or more vias, conduits, and/or channels extending through the layers.

The release rate of the components from the package can be controlled by, for example, the thickness of the tissue thickness compensator, the constituent parts of the tissue thickness compensator, the size of the components, the hydrophilicity of the components, and/or the Physical and/or chemical interactions in, components of tissue thickness compensators, and/or surgical instruments. The layer may include one or more thin sections or weakened portions (such as localized perforations), which may facilitate, for example, cutting into the layer and rupturing the encapsulation. Partial perforations may not extend completely through the layer, while in some cases the perforations may extend completely through the layer.

Optionally, the anvil may include a tissue thickness compensator comprising an encapsulated component having at least one microspheroidal particle. The tissue thickness compensator can include an enclosure including a first encapsulating component and a second encapsulating component. The tissue thickness compensator can include an encapsulation including first microspherical particles and second microspherical particles.

A tissue thickness compensator may be adapted for use with a surgical instrument. As noted above, a tissue thickness compensator can be associated with the staple cartridge and/or the anvil. The tissue thickness compensator can be configured to fit any shape, size and/or dimension of the staple cartridge and/or anvil. As described herein, the tissue thickness compensator can be releasably attachable to the staple cartridge and/or the anvil. The tissue thickness compensator may be attached to the staple cartridge and/or the anvil in any mechanical and/or chemical manner capable of maintaining the tissue thickness compensator in contact with the staple cartridge and/or the anvil prior to and during the stapling procedure . After the staples have pierced the tissue thickness compensator, the tissue thickness compensator can be removed or released from the staple cartridge and/or the anvil. The tissue thickness compensator can be removed or released from the staple cartridge and/or the anvil as the staple cartridge and/or the anvil are moved away from the tissue thickness compensator.

Referring now to FIG. 14 , a staple cartridge, such as staple cartridge 10000 , for example, can include a support portion 10010 and a compressible tissue thickness compensator 10020 . Referring now to FIGS. 16-18 , the support portion 10010 can include a deck surface 10011 and a plurality of staple cavities 10012 defined in the support portion 10010 . Each staple cavity 10012, for example, can be sized and capable of removably storing a staple, such as staple 10030, therein. The staple cartridge 10000 can also include a plurality of staple drivers 10040, each staple driver capable of supporting one or more staples 10030 within the staple cavity 10012 when the staples 10030 and staple drivers 10040 are in their unfired positions. For example, referring first to FIGS. 22 and 23 , each staple driver 10040 can include, for example, one or more brackets or slots 10041 configured to support the staples and limit relative movement between the staples 10030 and the staple drivers 10040 . Referring again to FIG. 16 , the staple cartridge 10000 can also include a staple firing sled 10050; the staple firing sled can be moved from the proximal end 10001 of the staple cartridge to the distal end 10002 of the staple cartridge to sequentially drive the staple drivers 10040 and the staples 10030 The anvil is positioned opposite the staple cartridge 10000 from its unfired position to lift. Referring first to FIGS. 16 and 18 , each staple 10030 can include a base 10031 and one or more legs 10032 extending from the base 10031 , wherein each staple can be at least one of, for example, substantially U-shaped and substantially V-shaped. The staples 10030 are capable of being such that the top ends of the staple legs 10032 are recessed relative to the deck surface 10011 of the support portion 10010 when the staples 10030 are in their unfired position. The staples 10030 are capable of being such that the top ends of the staple legs 10032 are flush with respect to the deck surface 10011 of the support portion 10010 when the staples 10030 are in their unfired position. The staples 10030 can be configured such that the top ends of the staple legs 10032 or at least some portion of the staple legs 10032 extend above the deck surface 10011 of the support portion 10010 when the staples 10030 are in their unfired position. In this case, the staple legs 10032 can extend into and be embedded into the tissue thickness compensator 10020 when the staples 10030 are in their unfired positions. For example, staple legs 10032 can extend, for example, to approximately 0.075" above deck surface 10011. Staple legs 10032 can extend, for example, to a distance between approximately 0.025" and approximately 0.125" above deck surface 10011. Further to the above, tissue thickness compensation The piece 10020 can comprise, for example, an uncompressed thickness of between about 0.08" and about 0.125".

In use, as further described above and referring initially to FIG. 31 , an anvil such as anvil 10060 , for example, can be moved to a closed position opposite staple cartridge 10000 . As described in more detail below, the anvil 10060 can position tissue against the tissue thickness compensator 10020 and press the tissue thickness compensator 10020 against the deck surface 10011 of the support portion 10010, for example. Once the anvil 10060 has been properly positioned, the staples 10030 can be deployed, also as shown in FIG. 31 . Optionally, as described above, the staple firing sled 10050 is movable from the proximal end 10001 to the distal end 10002 of the staple cartridge 10000, as shown in FIG. 32 . When the sled 10050 is advanced, the sled 10050 can contact the staple drivers 10040 and lift the staple drivers 10040 upward within the staple cavities 10012. The sled 10050 and the staple drivers 10040 can each include one or more ramps or ramps that can cooperate to move the staple drivers 10040 upwardly from their unfired positions. For example, referring to FIGS. 19-23 , each staple driver 10040 can include at least one ramp 10042, and the sled 10050 can include one or more ramps 10052 that enable the sled 10050 to be advanced distally within the staple cartridge. , the slope 10052 slides under the slope 10042. As the staple drivers 10040 are lifted upward within their respective staple cavities 10012, the staple drivers 10040 can lift the staples 10030 upward so that the staples 10030 can emerge from their staple cavities 10012 through openings in the staple platform 10011. During an exemplary firing sequence, referring first to FIGS. 25-27 , the sled 10050 can first contact the staple 10030a and begin lifting the staple 10030a upward. As sled 10050 is advanced further distally, sled 10050 can begin to lift staples 10030b, 10030c, 10030d, 10030e, and 10030f and any other subsequent staples in sequence. As shown in FIG. 27 , the sled 10050 can drive the staples 10030 upward so that the legs 10032 of the staples in contact with the opposing anvil are deformed to the desired shape and ejected from the support portion 10010 . In various instances, the sled 10030 can move multiple staples upward simultaneously as part of a firing sequence. Referring to the firing sequence shown in FIG. 27, staples 10030a and 10030b have been moved to their fully fired positions and ejected from support portion 10010, staples 10030c and 10030d are in the process of being fired and are at least partially contained within support portion 10010, And staples 10030e and 10030f are still in their unfired positions.

As noted above and referring to FIG. 33 , the legs 10032 of the staples 10030 can extend above the deck surface 10011 of the support portion 10010 when the staples 10030 are in their unfired positions. With further reference to the firing sequence shown in FIG. 27 , staples 10030 e and 10030 f are shown in their unfired positions with their staple legs 10032 extending above deck surface 10011 and into tissue thickness compensator 10020 . The top ends of the staple legs 10032 or any other portion of the staple legs 10032 may not protrude through the top tissue contacting surface 10021 of the tissue thickness compensator 10020 when the staples 10030 are in their unfired positions. As shown in FIG. 27, the ends of the staple legs can protrude through the tissue contacting surface 10032 when the staples 10030 are moved from their unfired positions to their fired positions. The tips of the staple legs 10032 can include sharp tips capable of cutting and penetrating the tissue thickness compensator 10020 . The tissue thickness compensator 10020 can include a plurality of apertures configured to receive the staple legs 10032 and allow the staple legs 10032 to slide relative to the tissue thickness compensator 10020 . The support portion 10010 may also include a plurality of guides 10013 extending from the platform surface 10011 . The guide 10013 can be positioned adjacent to the staple cavity opening of the deck surface 10011 such that the staple legs 10032 can be at least partially supported by the guide 10013 . The guide 10013 can be positioned at the proximal end and/or the distal end of the staple cavity opening. According to the present invention, the first guide 10013 can be positioned at the first end of each staple cavity opening, and the second guide 10013 can be positioned at the second end of each staple cavity opening, such that each first guide 10013 can support a first staple leg 10032 of a staple 10030 and each second guide 10013 can support a second staple leg 10032 of a staple. Referring to Fig. 33, each guide 10013 can include a groove or slot, such as a groove 10016, into which a staple leg 10032 can be slidably received, for example. Optionally, each guide 10013 can include a cleat, protrusion, and/or spike extendable from the deck surface 10011 and extendable into the tissue thickness compensator 10020 . As described in more detail below, the cleats, protrusions, and/or spikes can reduce relative movement between the tissue thickness compensator 10020 and the support portion 10010 . The top ends of the staple legs 10032 may be positioned within the guide 10013 and may not extend above the top surface of the guide 10013 when the staple 10030 is in its unfired position. For example, the guides 10013 can define a guide height and may not extend above the guide height when the staples 10030 are in their unfired positions.

In accordance with the present invention, a tissue thickness compensator, such as tissue thickness compensator 10020, for example, can be constructed from a single sheet of material. The tissue thickness compensator may comprise a continuous sheet of material that may cover the entire top deck surface 10011 of the support portion 10010 , or alternatively less than the entire deck surface 10011 . The sheet of material may cover the staple cavity openings in the support portion 10010, however alternatively the sheet of material may include openings that may be aligned, or at least partially aligned, with the staple cavity openings. According to the invention, the tissue thickness compensator can consist of, for example, a plurality of layers of material. Referring now to FIG. 15, a tissue thickness compensator may include a compressible core and a wrap surrounding the compressible core. The wrap 10022 is capable of releasably retaining the compressible core to the support portion 10010 . For example, support portion 10010 may include, for example, extending therefrom one or more protrusions, such as protrusion 10014 ( FIG. 18 ), which may be received within one or more holes and/or slots, such as defined in a package. In the hole 10024 in the object 10022. The protrusion 10014 and hole 10024 enable the protrusion 10014 to retain the wrap 10022 to the support portion 10010 . The ends of the protrusions 10014 may be deformed, such as by a heat staking process, so as to enlarge the ends of the protrusions 10014 and thereby limit relative movement between the wrap 10022 and the support portion 10010 . The wrap 10022 can include one or more perforations 10025, which can facilitate releasing the wrap 10022 from the support portion 10010, as shown in FIG. 15 . Referring now to FIG. 24 , the tissue thickness compensator can include a wrap 10222 that includes a plurality of holes 10223 , wherein the holes 10223 can be aligned, or at least partially aligned, with the staple cavity openings in the support portion 10010 . The core of the tissue thickness compensator may also include holes aligned, or at least partially aligned, with the holes 10223 in the wrap 10222. Alternatively, the core of the tissue thickness compensator may comprise a continuous body and may extend below the holes 10223 such that the continuous body covers the staple cavity openings in the deck surface 10011.

Optionally, the tissue thickness compensator may include a wrap for releasably retaining the compressible core to the support portion 10010, as described above. For example, referring to FIG. 16 , the staple cartridge can also include a retainer clip 10026 that can inhibit premature separation of the wrap and compressible core from the support portion 10010 . Optionally, each retainer clip 10026 can include an aperture 10028 configured to receive a protrusion 10014 extending from the support portion 10010 such that the retainer clip 10026 can be retained to the support portion 10010 . Retainer clips 10026 can each include at least one flat bottom portion 10027 that can extend below support portion 10010 and support and retain staple drivers 10040 within support portion 10010 . As described above, the tissue thickness compensator can be removably attached to the support portion 10010 by the staples 10030 . More particularly, as also described above, when the staples 10030 are in their unfired positions, the legs of the staples 10030 can extend into the tissue thickness compensator 10020 and thereby releasably retain the tissue thickness compensator 10020 to the support portion 10010 . The legs of the staples 10030 can be in contact with the sidewalls of their respective staple cavities 10012, wherein the staples 10030 and the tissue thickness compensator 10020 can be held in place due to friction between the staple legs 10032 and the sidewalls until the staples 10030 are released from the staples. Pod 10000 is deployed. The tissue thickness compensator 10020 can be captured within the staple 10030 and held against the stapled tissue T after the staple 10030 is deployed. When the anvil is subsequently moved to the open position to release the tissue T, the support portion 10010 can be moved away from the tissue thickness compensator 10020 secured to the tissue. An adhesive may be used to removably retain the tissue thickness compensator 10020 to the support portion 10010. A two-part adhesive can be used, wherein a first part of the adhesive can be placed on the deck surface 10011 and a second part of the adhesive can be placed on the tissue thickness compensator 10020 such that when the tissue thickness compensator When 10020 is placed against platform surface 10011 , the first portion can contact the second portion to activate the adhesive and releasably bond tissue thickness compensator 10020 to support portion 10010 . Optionally, any other suitable method may be used to detachably retain the tissue thickness compensator to the support portion of the staple cartridge.

Further to the above, the sled 10050 can be advanced from the proximal end 10001 to the distal end 10002 to fully deploy all of the staples 10030 contained within the staple cartridge 10000 . Referring now to FIGS. 56-60 , the sled 10050 can be advanced distally within the longitudinal cavity 10016 within the support portion 10010 by a firing member or a knife bar 10052 of a surgical stapler. In use, staple cartridge 10000 can be inserted into a staple cartridge channel in the jaws of a surgical stapler, such as staple cartridge channel 10070, and firing member 10052 can be advanced into contact with sled 10050, as shown in FIG. When the sled 10050 is advanced distally by the firing member 10052, the sled 10050 can contact the proximal-most staple driver or driver 10040 and fire or eject the staples 10030 from the cartridge body 10010, as described above. As shown in FIG. 56, the firing member 10052 can also include a cutting edge 10053 that can be advanced distally through the knife slot in the support portion 10010 when the staples 10030 are fired. In accordance with the present invention, a corresponding knife slot can extend through an anvil positioned opposite the staple cartridge 10000 such that the cutting edge 10053 can extend between the anvil and the support portion 10010 and cut into tissue and tissue thickness positioned therebetween Compensation pieces. In various circumstances, the sled 10050 can be advanced distally by the firing member 10052 until the sled 10050 reaches the distal end 10002 of the staple cartridge 10000, as shown in FIG. 58 . At this point, the firing member 10052 can be retracted proximally. The sled 10050 can be retracted proximally with the firing member 10052, but referring now to FIG. 59, the sled 10050 can be left in the distal end 10002 of the staple cartridge 10000 when the firing member 10052 is retracted. Once the firing member 10052 has been sufficiently retracted, the anvil can be opened again, the tissue thickness compensator 10020 can be separated from the support portion 10010, and the remaining non-implanted portion of the depleted staple cartridge 10000, including the support portion 10010, can be removed from The staple cartridge channel 10070 is removed.

After the spent staple cartridge 10000 has been removed from the staple cartridge channel, further to the above, a new staple cartridge 10000 or any other suitable staple cartridge can be inserted into the staple cartridge channel 10070. Further to the above, the staple cartridge channel 10070, the firing member 10052, and/or the staple cartridge 10000 can include cooperating structures that prevent a new unfired staple cartridge 10000 from being positioned in the staple cartridge channel 10070. The firing member 10052 is again or subsequently advanced distally. More specifically, referring again to FIG. 56, when the firing member 10052 is advanced into contact with the sled 10050, and when the sled 10050 is in its proximal unfired position, the support nose 10055 of the firing member 10052 can be positioned at On and/or over the support flange 10056 on the sled 10050 such that the firing member 10052 is held in a sufficiently upward position to prevent the lock or beam 10054 extending from the firing member 10052 from falling into the lock defined in the staple cartridge channel. in the lock groove. Since the lock 10054 does not fall into the lock groove, in such cases the lock 10054 may not abut the distal sidewall 10057 of the lock groove when the firing member 10052 is advanced. As the firing member 10052 pushes the sled 10050 distally, the firing member 10052 can be supported in its upward firing position due to the support nose 10055 resting on the support flange 10056 . When the firing member 10052 is retracted relative to the slide 10050, as described above and as shown in FIG. location drop. For example, the surgical staple may include a spring 10058 and/or any other suitable biasing element capable of biasing the firing member 10052 to its downward position. Once the firing member 10052 has been fully retracted, as shown in FIG. 60 , the firing member 10052 cannot be advanced distally through the spent staple cartridge 10000 again. More specifically, the firing member 10052 cannot be held in its upper position by the sled 10050 when the sled 10050 in the operating sequence has been left at the distal end 10002 of the staple cartridge 10000 at this time. Therefore, as described above, if the firing member 10052 is advanced again without replacing the staple cartridge, the lock beam 10054 will contact the sidewall 10057 of the lock groove, which will prevent the firing member 10052 from being advanced further distally into the staples. The warehouse is 10000. In other words, once the spent staple cartridge 10000 has been replaced by a new staple cartridge, the new staple cartridge will have a proximally positioned slide 10050 that can hold the firing member 10052 upward position, and the firing member 10052 is advanced distally again.

As described above, the sled 10050 is configured to move the staple drivers 10040 between the first unfired position and the second fired position in order to eject the staples 10030 from the support portion 10010. After the staples 10030 have been ejected from the support portion 10010, the staple drivers 10040 can be received within the staple cavities 10012. Support portion 10010 can include one or more retention features configured to prevent staple drivers 10040 from being ejected or dropped out of staple cavities 10012 . Alternatively, the slider 10050 is capable of ejecting the staple drivers 10040 from the support portion 10010 with the staples 10030 thereon. For example, staple drivers 10040 can be constructed of, for example, bioabsorbable and/or biocompatible materials, such as polyetherimide (Ultem). Staple drivers can be attached to the staples 10030. For example, a staple driver can be molded on and/or around the base of each staple 10030 such that the driver is integrally formed with the staple. U.S. Patent Application No. 11/541,123, filed September 29, 2006, entitled "SURGICAL STAPLES HAVING COMPRESSIBLEOR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FORDEPLOYING THE SAME," is hereby incorporated by reference in its entirety.

As described above, a surgical stapling instrument may include a staple cartridge channel configured to receive a staple cartridge, an anvil rotatably coupled to the staple cartridge channel, and a firing member including a blade movable relative to the anvil and the staple cartridge channel . In use, a staple cartridge can be positioned within the staple cartridge channel, and when the staple cartridge is at least partially consumed, the staple cartridge can be removed from the staple cartridge channel and replaced with a new staple cartridge. For example, the staple cartridge channel, anvil, and/or firing member of a surgical stapling instrument may be reused with a replacement staple cartridge. Alternatively, the staple cartridge may comprise a portion of a disposable loading unit assembly, which may include, for example, a staple cartridge channel, an anvil, and/or a firing member, which may serve as part of a replacement disposable loading unit assembly. A part is replaced with the staple cartridge. Certain disposable loading unit assemblies are disclosed in U.S. Patent Application No. 12/031,817, entitled "END EFFECTOR COUPLING ARRANGEMENTS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT," filed February 15, 2008, the entire disclosure of which is set forth in Incorporated herein by reference.

The tissue thickness compensator may comprise an extrudable, castable and/or moldable composition comprising at least one of the synthetic and/or non-synthetic materials described herein. The tissue thickness compensator may comprise a film or sheet having two or more layers. The tissue thickness compensator can be obtained using conventional methods such as mixing, blending, combining, spraying, wicking, solvent evaporation, dipping, brushing, vapor deposition, extrusion, calendering, casting, molding, and the like. Upon extrusion, the opening may be in the form of a die comprising at least one opening to impart shape to the exposed extrudate. When calendering, the opening may comprise a nip between two rolls. Conventional molding methods may include, but are not limited to, blow molding, injection molding, foam injection, compression molding, thermoforming, extrusion, foam extrusion, film blowing, calendering, spinning, solvent welding, coating methods such as dip coating and spin coating, solution casting and film casting, plastisol processing (including knife coating, roll coating and casting), and combinations thereof. In injection molding, openings may include nozzles and/or channels/runners and/or mold cavities and features. In compression molding, a composition may be positioned within a mold cavity, heated to a suitable temperature, and shaped by being compressed under relatively high pressure. When casting, the composition may comprise a liquid or slurry that is poured or otherwise provided into, onto, and/or around a mold or object to replicate the features of the mold or object. After casting, the composition can be dried, cooled and/or solidified to form a solid.

According to the present invention, a method of making a tissue thickness compensator comprising at least one drug retained and/or absorbed therein may generally comprise providing the tissue thickness compensator, and contacting the tissue thickness compensator with the drug to retain the drug in the tissue thickness in compensation. A method of making a tissue thickness compensator comprising an antimicrobial material may comprise providing a hydrogel, drying the hydrogel, swelling the hydrogel in an aqueous solution of silver nitrate, contacting the hydrogel with a sodium chloride solution to form a tissue having antimicrobial properties. tissue thickness compensator. The tissue thickness compensator may include silver dispersed therein.

Referring now to FIG. 116, a tissue thickness compensator (eg, tissue thickness compensator 22020) can be attached, for example, to an anvil (eg, anvil 22060) of a surgical stapling instrument. The tissue thickness compensator 22020 can include a cavity 22024 defined between a first membrane 22026 and a second membrane 22027 , wherein at least a portion of the first membrane 22026 is attached to the second membrane 22027 . For example, the first film 22026 can be attached to the second film 22027 along, for example, transverse seam 22028a and transverse seam 22028b. The first membrane 22026 can be attached to the second membrane 22027 along the sealed perimeter so as to sealingly enclose the cavity 22024 . The first membrane 22026 and the second membrane 22027 may be thermally welded, for example, along the transverse seams 22028a, 22028b and/or any other seam connecting the membranes 22026 and 22027. Referring again to FIG. 116 , the anvil 22060 can include a plurality of staple forming pockets 22062 each capable of receiving and deforming a leg of a staple, wherein the second membrane 22027 can include a plurality of staple forming pockets 22062 that can extend into the forming pockets. Protrusion 22022 within pocket 22062. Protrusion 22022 can be sized and configured to fit snugly within forming pocket 22062 and to retain tissue thickness compensator 22020 to anvil 22060 . As shown, the anvil 22060 can include, for example, six rows of shaped pockets 22062 , wherein the tissue thickness compensator 22020 can similarly include six rows of protrusions 22022 aligned with the shaped pockets 22062 . Other embodiments including more or less than six rows of shaped dimples 22062 and/or protrusions 22022 may be used. One or more adhesives can be used to hold the tissue thickness compensator 22020 to the anvil 20060.

As noted above, the tissue thickness compensator 22020 can include a cavity 22024 defined therein. The cavity 22024 can extend longitudinally along the anvil 22060 . Referring again to FIG. 116 , the tissue thickness compensator 22020 can comprise a compressible material positioned within the cavity 22024 . Referring now to FIG. 117 , staples (eg, staples 22030 ) can be ejected, for example, from a staple cartridge such that the staples 22030 penetrate the tissue T and subsequently penetrate the tissue thickness compensator 22020 before contacting the anvil 22060 . As the legs of the staples 22030 are deformed by the anvil 22060, the legs can be turned down to penetrate the tissue thickness compensator 22020 again. In any event, once the staples 22030 have penetrated the tissue thickness compensator 22020, one or more fluids contained within the cavities 22024 can flow or seep from the tissue thickness compensator 22020 onto the tissue T, for example. The cavity 22024 can include, for example, one or more powders contained therein that can escape the cavity 22024 once the tissue thickness compensator 22020 has been at least partially ruptured by the staples 22030 . In accordance with the present invention, the material 22025 positioned within the cavity 22024 can be compressed or squeezed within the staple 22030 when the staple 22030 is deformed into its fired configuration such that fluid stored within the material 22025 can be forced out of the material 22025, for example . Referring again to FIG. 117 , staples 22030 are also capable of capturing a tissue thickness compensator (eg, compensator 22029 ), such as removably attached to the staple cartridge on the other side of tissue T, for example.

Further to the above, material 22025 may include, for example, freeze-dried thrombin, freeze-dried fibrin, and/or fine fiber nonwoven oxidized regenerated cellulose. Material 22025 may comprise compressed powder wafers. The sealed cavity 22024 may include an internal gas at a pressure lower than the pressure of the atmosphere surrounding the tissue thickness compensator 22020 . In this case, the pressure differential between the gas in the internal cavity 22024 and the atmosphere can cause the membranes 22027 and 22028 to be drawn inwardly. After the internal cavity 22024 is ruptured by the staple 22030, as described above, the vacuum within the internal cavity 22024 can equilibrate with the surrounding atmosphere and material 22025 can escape the internal cavity 22024, also as described above. In such instances, tissue thickness compensator 22020 can expand and apply a compressive force to tissue T captured within staples 20030 . Where material 22025 is vacuum encapsulated within tissue thickness compensator 22020, material 22025 may expand after internal cavity 22024 has been pierced. The membranes 22026, 22027 may be constructed of bioabsorbable material and capable of dissolving once placed within the patient. For example, each film 22026, 22027 can be composed of a layer or laminate having a thickness, for example, between about 0.25 mil and about 0.50 mil. In any event, further to the above, when the staples 22030 are fired from their cartridges, the tissue thickness compensator 22020 comprising the material 22025 can be transected by the cutting elements.

Referring again to FIG. 116 , the cavities 22024 and material 22025 of the tissue thickness compensator 22020 can be positioned under the four inner rows of staple forming pockets 22062 while the seams 22028a, 22028b can be positioned under the outer rows of the forming pockets 22062 under. In this case, the staples in the outer row of staples may not engage the material 22025, and thus they may not capture the material 22025 therein. Instead, such staples may only capture the membranes 22026 and 22027 along the seams 22028a, 22028b. Alternatively, referring now to FIGS. 118 and 119 , the tissue thickness compensator 22120 may include a first membrane 22126 , a second membrane 22127 , and a membrane captured between the first membrane 22126 and the second membrane 22127 in a manner similar to the above. Multiple materials between 22125a-d. For example, referring primarily to FIG. 118, a first material 22125a can be aligned with the outer rows of staples 22030 in the staple cartridge 22000 and the outer rows of staple cavities 22062 in the anvil 22060, and the second material 22125b and the third material 22125c can each be aligned with the staples. Two inner rows of staple cavities 22062 and 22030 are aligned, and the fourth material 22126d can be aligned with the other outer row of staples 22030 and staple cavities 22062. In such a case, referring now to FIG. 119, all of the staples 22030 may be arranged such that they may capture at least one of the materials 22125a-22125d therein. Further to the above, as shown in FIGS. 118 and 119 , staples 22030 can be lifted upwardly by staple drivers 22040 positioned within staple cartridge 22000 between an unfired position and a fired position.

Referring again to FIGS. 118 and 119 , layers 22126 and 22127 can define one or more sealed cavities in which materials 22125a-d can be disposed. Layer 22126 and layer 22127 may be sealed together along the perimeter, which may include transverse seam 22128a and transverse seam 22128b, eg, using any suitable method (eg, heat welding and/or laser welding). Each of the materials 22125a-22125d may be sealed within a separate cavity, while alternatively two or more of the materials 22125a-22125d may be sealed within the same cavity. Materials 22125a-22125d may be composed of the same material, while alternatively one or more of materials 22125a-22125d may be composed of different materials. One or more of the materials 22125a-22125d can be composed of, for example, sodium stearate and/or LAE. Materials 22125a-22125d may include a lubricant. In such cases, the legs of the staples 22030 can be exposed to lubricant as the staple legs penetrate the material 22125a - 22125d of the tissue thickness compensator 22120 . After the legs pass through the tissue thickness compensator 22120, the legs can contact the anvil 22060, wherein the lubricant can reduce the coefficient of friction and friction between the staple legs and the anvil 22060. In such cases, the force required to fire the staples 22030 may be reduced. Due to the positioning of the tissue thickness compensator 22120 against the anvil 22060, the legs of the staples 22030 can directly contact the anvil 22060 after exiting the tissue thickness compensator 22120, thereby reducing the amount of contact that can be made from the staple legs before the staple legs contact the anvil 22060. Possibility of wiping off lubricant. Similarly, the legs of the staples 22030 can directly contact the anvil 22060 after exposure to the one or more drugs within the tissue thickness compensator 22120, thereby reducing the chance of wiping off the staple legs before re-entering the tissue T. drug possibility. In some cases, the staple legs can re-enter the tissue thickness compensator 22120 as the staple legs are deformed downward such that the staple legs can be re-exposed to the drug prior to re-entering the tissue T, for example. Optionally, similar to above, the second membrane 22127 can include a plurality of protrusions 22122 that can be snugly received within the staple cavities 22062, for example, to retain the tissue thickness compensator 22120 to the anvil 22060, for example.

Referring now to FIGS. 120 and 121 , the end effector of a surgical stapling instrument can include a tissue thickness compensator (e.g., compensator 22220 ), which can, for example, include a staple forming pocket 22062 aligned with an anvil 22060 . Multiple cavities 22222. The compensator 22220 can be comprised of a first or bottom layer 22226 and a second or top layer 22227 , wherein the first layer 22226 and/or the second layer 22227 can include a plurality of raised portions or localized air cells that can define the cavity 22222 . As shown in FIG. 120 , the compensator 22220 can be attached to the anvil 22060 such that the cavities 22222 are aligned or at least substantially aligned with the staple forming pockets 22062 of the anvil 22060 . Optionally, each cavity 22222 can include one or more drugs contained therein, eg, oxidized regenerated cellulose, calcium, and/or alginate. During use, each cavity 22222 can be in a sealed, unpunctured state prior to piercing, eg, by a staple 22030 fired from the staple cartridge 22000 . Referring now to FIG. 121 , after the legs of the staples 22030 have passed through the tissue T, each staple leg can pierce and penetrate the first layer 22226 and enter the cavity 22222 where the staple legs can then pierce and penetrate the second layer 22222 . Layer 22227 is previously passed through one or more drugs contained therein. Similar to the above, the legs of the staples 22030 can then contact the anvil 22060.

The cavity 22222 can maintain the one or more medicaments stored therein in a dry state, or at least a substantially dry state, prior to rupture. After the cavity 22222 has been ruptured, fluid (eg, blood) can enter the cavity 22222 and mix with the one or more drugs. The mixture of the fluid and the drug can cause the drug to expand within the cavity 22222, where, for example, the drug can include, for example, at least one hydrogel. The medicament may include, for example, at least one hemostatic material. The first layer 22226 and/or the second layer 22227 can be constructed of a flexible material that can stretch to accommodate expansion of the drug. Layers 22226, 22227 may be composed of, for example, a CAP/GLY material. In any event, expansion of the drug may, for example, apply a compressive force to tissue captured within and/or positioned around the staples 22030 . In various circumstances, expansion of the drug may cause the lumen 22222 to rupture. For example, a first set of cavities 22222 can include a first medicament therein, while a second set of cavities 22222 can include a second medicament therein. For example, a first drug is capable of swelling a first amount and/or at a first rate, and a second drug is capable of swelling a second amount and/or at a second rate, e.g., wherein the first amount may be different from the second amount and /Or the first rate may be different than the second rate. Further to the above, one or more cavities 22222 can include one or more medicaments stored in each cavity, where the medicaments can include, for example, a first medicament and a second medicament. The cavity 22222 can hold the first medicament and the second medicament in a dry state, or at least a substantially dry state, prior to rupture. As described above, after the cavity 22222 has been ruptured, blood, for example, can enter the cavity 22222 and mix with the first and second medicaments, which can form a swollen gel.

Referring now to FIGS. 122-124, a tissue thickness compensator (eg, compensator 22320) can include a first plurality of cavities 22322a and a second plurality of cavities that can be aligned with staple forming pockets 22062a and staple forming pockets 22062b, respectively. 22322b. Referring primarily to FIG. 123 , the staple forming pockets 22062 a and the staple forming pockets 22062 b can be defined in separate stepped surfaces on the anvil 22060 . More specifically, for example, a forming pocket 22062a can be defined in a first surface 22069a of the anvil 22060, and a forming pocket 22062b can be defined in a second surface 22069b, wherein the first surface 22069a can be positioned offset or high. The first cavity 22322a of the tissue thickness compensator 22320 may be larger than the second cavity 22322b on the second surface 22069b, wherein, for example, the first cavity 22322a may extend higher than the second cavity 22322b. As a result of the foregoing, the first cavity 22322a can extend upwardly into the first staple forming pocket 22062a while the second cavity 22322 can extend upwardly into the second staple forming pocket 22062b. Optionally, each first cavity 22322a can contain, for example, a greater amount of drug than the second cavity 22322b. Alternatively, the first cavity 22322a and the second cavity 22322b can contain the same or at least substantially the same amount of drug therein, even though the cavity 22322a and the cavity 22322b can have different dimensions.

Further to the above, the first cavities 22322a may be arranged in a particular row, while the second cavities 22322b may be arranged in a different row. The tissue thickness compensator can include a cavity that aligns with each of the shaped pockets, while alternatively, referring to FIG. Aligned cavities. Referring again to FIG. 123 , the compensator 22320 can be attached to the anvil 22060 . Cavities 22322a and/or cavities 22322b can be configured such that they snugly fit within staple forming pockets 22062a and/or staple forming pockets 22062b, respectively. The compensator 22320 can be assembled to the anvil 22060 such that the second layer 22327 of the compensator 22320 is positioned against the second surface 22069b of the anvil 22060 . Alternatively, referring now to FIGS. 125 and 126 , compensator 22320 can be positioned adjacent to anvil 22060 such that when anvil 22060 is moved toward staple cartridge 22000 to compress tissue T therebetween, compensator 22320 can abut Anvil 22060. Referring now to FIG. 127 , once staples 22030 have been fired from staple cartridge 22000 and deformed by anvil 22060 , compensator 22320 can be captured against tissue T by staples 22030 and anvil 22060 can be moved away from compensator 22320 . In some instances, referring now to FIG. 128 , one or more of the staples 22030 may not be properly deformed by the anvil 22030 . In such cases, referring now to FIG. 129, the cavities in the tissue thickness compensator overlying the unfired or unformed staples may not be pierced when the staples are fired. For example, the tissue thickness compensator may be constructed of a bioabsorbable material that dissolves and subsequently releases the drug contained in the unpunctured cavity.

Further to the above, the first cavity 22322a and/or the second cavity 22322b of the tissue thickness compensator 22320 can include, for example, a gas sealed therein, eg, air, carbon dioxide, and/or nitrogen. The cavities 22322a and/or the cavities 22322b can include gas bubbles that can burst when the staples 22030 are fired through the cavities 22322a and/or the cavities 22322b to release the gas contained therein. This popping can provide audible feedback to the surgeon who is rupturing the cavities 22322a and 22322b. However, in some instances, some staples 22030 may be unfired, as described above, and their associated cavities 22322a and 22322b may not be burst. In various cases, the surgeon can scan the sutured tissue for any unpopped air bubbles, or cavities 22322a and 22322b, and determine if any corrective action needs to be taken.

As mentioned above, referring now to FIG. 131 , a surgical stapling instrument can include a firing member, for example, a firing member 22080 that can include a cutting member or cutting edge 22081 that can be activated at the firing member 22080. The staples 22030 are advanced through the tissue T and one or more tissue thickness compensators when advanced through the cartridge 22000 to deploy therefrom. Referring primarily to FIG. 133 , a compensator (eg, compensator 22520 ) can be attached to an anvil 22060 of a surgical stapling instrument, wherein the anvil 22060 can include a knife slot 22061 sized and configured to receive at least a portion of a cutting member 22081 . Similarly, staple cartridge 22000 can include knife slot 22011 that can also be sized and configured to receive at least a portion of cutting member 22081 . Referring again to FIG. 131 , the compensator 22520 can include one or more cavities positioned, for example, along a cut line 22521 of the compensator 22520 , for example, a cavity 22522 , wherein the cavities 22522 can interface with a knife slot defined in the anvil 22060 22061 aligned. As cutting member 22081 is advanced distally through staple cartridge 22000 to deploy staples 22030 , cutting member 22081 can cut into tissue T and lumen 22522 of compensator 22520 . Similar to the above, referring primarily to FIG. 132 , each cavity 22522 can define a sealed cavity 22524 that can contain one or more medicaments 22525 therein. One or more of the cavities 22522 can contain a fluid that can be released when the cavities 22522 are at least partially incised by the cutting member 22081 . In various instances, the cutting member 22081 can continuously cut into the cavity 22522, and thus can continuously release the drug contained therein.

Referring primarily to Fig. 133, the compensator 22520 may include lateral protrusions or wings 22529 extending along the sides thereof. The protrusions 22529 can be secured to the anvil surface 22069a and/or the anvil surface 22069b using, for example, one or more adhesives. The protrusion 22522 can be sized and configured to fit snugly within the knife slot 22061 of the anvil 22060 such that the protrusion 22522 can retain the compensator 22520 to the anvil 22060 , for example. Lateral projections 22529 can be sized and configured to extend into or overlie staple forming pockets 22062b and/or staple forming pockets 22062a. Alternatively, referring now to FIGS. 134 and 135 , the compensator 22620 may include lateral protrusions 22629 that do not extend to or overlie the staple forming pockets 22062a and 22062b of the anvil 22060, for example, and / or any other nail forming dimples. For example, compensator 22620 may not be captured within staples 22030 fired from staple cartridge 22030 . In any event, referring again to FIG. 131 , the cutting member 22081 can transect the compensator 22520 when the compensator 22520 is secured to tissue T by the staples 22030 . In such circumstances, the compensator 22520 can be separated from the anvil 22060 and retained with the tissue T. Referring again to the compensator 22620 shown in FIGS. 134 and 135 , the staples 22030 may not secure the compensator 22620 to the anvil 22060 and may remain attached to the compensator 22620 after the cutting member 22081 has transected the compensator 22620 22060.

Referring now to FIGS. 136 and 137 , the end effector of a surgical stapling instrument can include a tissue thickness compensator, such as compensator 22720 , that is attachable or attachable to an anvil, such as anvil 22760 , etc. Wait. Similar to the above, the anvil 22760 can include a plurality of staple forming pockets 22762 and a longitudinal knife slot 22761 configured to receive a cutting member therein as it is advanced through the end effector. The compensator 22720 can include a first film layer 22726 and a second film layer 22727 that can be attached to each other to define a cavity 22724 . For example, the first film layer 22726 can be attached to the second film layer 22727 along a sealed outer perimeter 22728 , wherein the sealed outer perimeter 22728 can accommodate at least one drug 22725 in the cavity 22724 , for example. As shown in FIG. 137 , the cavity 22724 and the drug 22725 can extend below all of the staple cavities 22762 and the sealed perimeter 22728 can be positioned laterally relative to the outermost staple cavities 22762 . The compensator 22720 may also include, for example, a longitudinal rib 22721 that can extend upwardly into the knife slot 22761 . For example, rib 22721 may be sized and configured to fit snugly within knife slot 22761 to secure compensator 22720 to anvil 22760 . Ribs 22721 enable alignment or centering of compensator 22720 with anvil 22760 . Similarly, referring to FIG. 138 , tissue thickness compensator 22820 can include retention ribs 22821 that can be positioned within knife slot 22761 , for example, to secure compensator 22820 to anvil 22760 . Referring again to FIG. 137 , in various circumstances, when the cutting member is advanced through the knife slot 22761 , the cutting member can transect the rib 22721 and release the compensator 22720 from the anvil 22760 . For example, such a cutting member is shown in FIG. 138 as part of firing member 22080.

Referring again to FIG. 138, the tissue thickness compensator 22820 can include a first layer 22826 and a second layer 22827, which can be constructed and arranged to define a plurality of first packets 22824a and a plurality of second layers 22824a. Second packet 22824b. Each of the first packets 22824a can contain a first medication, and each of the second packets 22824b can contain a second medication, where the second medication can be different from the first medication. The first packets 22824a and the second packets 22824b may be arranged in an alternating configuration. For example, the first packet 22824a and the second packet 22824b can extend laterally across the tissue thickness compensator 22820 such that, for example, the second packet 22824b is positioned between the two first packets 22824a and the first packet 22824a is positioned between the two second packets. In the middle of packet 22824b. As the cutting member 22080 travels through the compensator 22820, as shown in FIG. 138, the cutting member 22080 may transect the first packet 22824a, followed by the second packet 22824b, followed by the first packet 22824a, followed by the second packet 22824b, etc. Wait. Accordingly, in such cases, the cutting member 22080 may successively release, for example, a first medicament contained in a first packet 22824a and a second medicament contained in a second packet 22824b, said first packet 22824a and said The second packet 22824b is in an alternating configuration. With the first packet 22824a and the second packet 22824b positioned adjacent to each other, when the first drug and the second drug are released from their respective first packet 22824a and second packet 22824b, the first drug can interact with the second packet 22824a and second packet 22824b. The two drugs are mixed. For example, advancement of the cutting member through compensator 22820 may cause the first medicament to mix with the second medicament.

Further to the above, the first medicament may comprise a first powder and the second medicament may comprise a second powder. The first medicament and/or the second medicament may consist of eg a hemostatic material, oxidized regenerated cellulose, alginate, and/or calcium. The first medicament and/or the second medicament may comprise a fluid. One or more of the first packets 22824a and/or one or more of the second packets 22824b can include a lubricant that reduces the effort required to advance the firing member 22080 through the compensator 22820 and/or tissue T. required force. The first film layer 22826 and/or the second film layer 22827 can be comprised of, for example, a bioabsorbable material such as PDS. The first membrane layer 22826 and the second membrane layer 22827 can be attached to each other such that the first packet 22824a is sealed from the second packet 22824b prior to incision by the firing member 22080 . The first packet 22824a and/or the second packet 22825b may have a certain burst strength so as to withstand a certain burst pressure. More specifically, when an anvil (e.g., anvil 22760) moves compensator 22820 toward a staple cartridge positioned away from anvil 22760, packets 22824a, 22824b can be positioned to be positioned adjacent to packets 22824a, 22824b Tissue intermediate to the staple cartridge, wherein the anvil 22760 can then be pushed or clamped downwardly toward the staple cartridge so as to compress the tissue positioned therebetween. In such cases, the packets 22824a, 22824b may be subjected to compressive pressure. In some cases, it is desirable for the packets 22824a and/or the packets 22824b to remain intact until they are incised by the cutting member 22080 and/or pierced by staples fired from the staple cartridge. In certain other circumstances, it may be desirable for the packets 22824a and/or 22824b to rupture due to compressive clamping loads applied thereto.

As described above, the first packet 22824a and the second packet 22842b can extend laterally across the compensator 22820 . For example, the first packet 22824a can extend along the transverse axis 22823a, while the second packet 22824b can extend along the transverse axis 22823b. The first axis 22823a and/or the second axis 22823b may be perpendicular, or at least substantially perpendicular, to the longitudinal axis 22083 of the compensator 22820 . For example, the longitudinal axis 22083 can define the cutting path of the firing member 22080. The first axis 22823a and/or the second axis 22823b may not be perpendicular to the longitudinal axis 22083 and may be inclined relative to the longitudinal axis 22083 . Optionally, as described above, the first packets 22824a and the second packets 22824b may be arranged in an alternating configuration. Alternatively, any other suitable configuration of the first packet 22824a and the second packet 22824b may be used. For example, a sequence of packets disposed in a tissue thickness compensator may include a first packet 22824a, a second packet 22824b, a second packet 22824b, and a first packet 22824a. The tissue thickness compensator may also include a plurality of third packets including a third drug different from the first drug and the second drug. For example, the first pack, the second pack, and the third pack may be arranged in an alternating configuration. For example, a sequence of packets arranged in a tissue thickness compensator may include, for example, a first packet followed by a second packet followed by a third packet.

Referring again to FIG. 138, the first packet 22824a and/or the second packet 22824b of the tissue thickness compensator 22820 can define a U-shaped, or at least substantially U-shaped, cross-section, for example. Referring now to FIG. 139, the packet 22924 of the tissue thickness compensator 22920 can define, for example, a circular, or at least substantially circular, cross-section. Referring now to FIG. 140, the packet 23024 of the tissue thickness compensator 23020 can define, for example, an oval and/or elliptical cross-section. Referring again to FIG. 138, the first cavities 22824a and the second cavities 22824b can comprise a symmetrical or at least nearly symmetrical configuration defined in parallel or at least substantially parallel rows. Alternatively, referring now to FIG. 141 , a tissue thickness compensator (e.g., compensator 23120) can include an asymmetric cavity 23122 defined therein, which can have, for example, irregular and/or non-repeating pattern. For example, each of cavities 23122 can contain one or more different drugs therein.

Referring now to FIG. 142 , a tissue thickness compensator (eg, tissue thickness compensator 23220 ) can include a housing 23226 defining a cavity 23224 therein and a material 23225 positioned within the cavity 23224 . Housing 23226 can be composed of, for example, absorbable polymers, PDS, PGA, PLLA, Cap Gly, and/or PCL, while material 23225 can be composed of, for example, hemostats, oxidized regenerated cellulose, Hercules, fibrin, and/or thrombin , the material 23225 may take any suitable form, such as powder, fiber, and/or gel. Housing 23226 may be fabricated using an extrusion process. In such cases, the housing 23226 can include a constant, or at least substantially constant, cross-section along its length, which can be produced without having to be welded with seams. For example, cavity 23224 may be defined by sidewalls extending around its entire perimeter that do not have openings defined therein. Housing 23226 may be constructed of a mesh and/or straw-like material with openings defined therein. Openings may be cut in housing 23226 by, for example, a laser cutting process and/or a die cutting process.

As part of making material 23225, referring now to FIGS. 145-147, yarn strands may be formed using fibers and/or fibrous materials (eg, oxidized regenerated cellulose). The longer fibers 23325 shown in FIG. 145 and the shorter fibers 23425 shown in FIG. 146 may be mixed together in the manner shown in FIG. 147 to form strands of material 23225. The yarn strands may be drawn under tension and/or may be placed under tension so as to stretch the fibers contained therein in the machine direction. Referring now to FIG. 148, the strands of material 23225 can be fluffed by graspers 23290, which can grasp and twist the material 23225 to increase the volume of the strands of yarn. For example, the grasper 23290 can fluff the material 23225 while the strands of yarn are moving relative to the grasper 23290, for example. Referring again to FIG. 148 , cutting members 23291 can be utilized, for example, in strands of material 23225 to make small and/or micro-cuts. Similar to the above, cutting member 23291 may cut material 23225 while strands of yarn are moving relative to cutting member 23291 . The yarn strands of material 23225 may be fluffed prior to making the cuts described above, or alternatively, the yarn strands of material 23225 may be cut in prior to their fluffing.

Once the strands of material 23225 have been suitably prepared, the material 23225 may be positioned within the housing 23225. Referring now to FIG. 149 , two or more housings 23226 can be formed together as part of the extrusion process described above, wherein the housings 23226 can be joined together as part of a tube 23227 . The yarn strands of material 23225 may be positioned or drawn into cavities 23224 defined in tube 23227 . The strands of material 23225 can be positioned near and/or within the first open end 23221 of the cavity 23224 into which the grasper 23292 can be inserted through the second open end 23222 of the cavity 23224 . The grasper 23292 can then be pushed through the cavity 23224 until the jaws 23292a of the grasper 23292 pass through the first open end 23222 and/or are positioned relative to the first open end 23222 such that the grasper jaws 23292a can be Manipulates to grasp the strands of material 23225. The grasper may include, for example, hook members capable of grasping strands of material 23225 . In any event, once the graspers 23292 have sufficiently grasped the strands of material 23225, the graspers 23292 can be withdrawn into the cavities 23224 so as to draw the strands of material 23225 into the cavities 23224. Grasper 23292 is capable of twisting the strands of material 23225 before, during, and/or after the strands are drawn into tube 23227.

Once the strands of material 23225 have been properly positioned within the tube 23227, the grasper 23292 may then be manipulated to release the strands of material 23225. The yarn strands can be released before the yarn strands have been drawn through the second open end 23222 of the tube 23227, and alternatively, can be released after the yarn strands have been drawn through the second open end 23222 Yarn strands, as shown in Figure 150. In some cases, the yarn strand can be pulled through the second open end 23222 such that when the yarn strand is released, the yarn strand can retract or spring back into the tube 23227 through the second open end 23222. In various cases, the yarn strands may be cut adjacent to the first open end 23221 such that the yarn strands may retract or spring back into the tube 23227 through the first open end 23222, similar to above. In various cases, further to the above, the grasper 23292 can apply tension to the strands of material 23225 such that when the grasper 23292 releases the strands and/or when the strands are cut, the strands The tension in the thread can be released allowing the yarn strands to shrink.

Referring now to FIG. 151 , once the strands of material 23225 have been sufficiently positioned within the tube 23227, the tube 23227 and material 23225 can be cut into sections, where each section can be prepared, for example, as a tissue thickness compensator 23220. The cavity 23224 of the cover 23226 extending through each such section may include open ends at opposite ends thereof. For example, one or both of the open ends may be closed and/or sealed by processes such as heat riveting, thermal welding, and/or laser welding. Referring to FIG. 152 , a section comprising a cover 23226 and a portion of material 23225 therein can be positioned within a mold capable of closing and/or sealing the open end of the cover 23226 . More specifically, the mold may, for example, include a base 23294 and a movable portion 23296 , wherein segments may be positioned within cavities 23295 defined in the base 23294 . Once positioned, the moveable portion 23296 can move downward to apply force to the segment. Optionally, the segments can be heated via the base 23294 and/or the movable portion 23296, wherein the heat and/or force applied to the segments can deform the cover 23226. More specifically, the movable portion 23296 can define a dimple 23297 that can be contoured to apply a clamping force to portions of the cover 23226 (eg, its open end) to close, flatten , and/or neck those portions of the tissue thickness compensator 23220. For example, the dimples 23297 can form the closed end 23228 of the tissue thickness compensator 23220 and flatten the portion of the tissue thickness compensator 23220 positioned intermediate the closed end 23228 . After the tissue thickness compensator 23220 has been suitably formed, the movable portion 23296 can be moved to the open position and the tissue thickness compensator 23220 can be removed from the mold. The tissue thickness compensator 23220 can then be positioned in a cooling container, wherein the compensator 23220 can be allowed to cool to room temperature and/or any other suitable temperature.

Alternatively, further to the above, the tube 23227 may be positioned within the thermoforming die after the material 23225 has been positioned in the tube 23227 . After the tube 23227 and material 23225 positioned therein have been formed, the tube 23227 and material 23225 can then be divided into a plurality of tissue thickness compensators 23220, for example. Referring again to FIG. 142 , the tissue thickness compensator 23220 can include lateral wings or clamps 23229 that can be attached to the anvil 22060 , for example. For example, when tissue thickness compensator 23220 is formed between mold portion 23294 and mold portion 23296, lateral wings 23229 can be formed in cover 23226, as described above. Referring now to FIG. 143 , the tissue thickness compensator 23320 can include lateral wings 23329 extending from the cover 23326 . Referring now to FIG. 144 , a tissue thickness compensator 23420 can, for example, include a cover 23426 having one or more laterally flexible joints 23428 that can allow the cover 23426 to operate when exposed to heat as described above. Deflects and flattens when subjected to compressive pressure in a forming die. Optionally, due to the above, the tissue thickness compensator 23220 may not include transverse seams. In such cases, referring again to FIG. 142 , material 23225 can extend to the lateral edges of anvil 22060 , for example.

As noted above, yarn strands may be drawn through the tube and then cut to length to form one or more tissue thickness compensators. Further to the above, strands of rigid material may be utilized to pull or push strands of yarn through the tube. Rigid strands of polymeric material such as PCL may be heated, for example, above its glass transition temperature and stretched into a deformed shape. For example, a rigid strand may comprise an undeformed helical shape which, when stretched into its deformed shape, may comprise, for example, a rectilinear or at least substantially rectilinear shape. The rigid strands can then be cooled below the glass transition temperature while constraining the rigid strands so that the rigid strands can retain their deformed shape. Once the rigid strand is in its deformed fibers, strands of yarn can be formed, for example, around the rigid strand. ORC yarn strands may, for example, be wound, gathered, and/or folded over rigid strands. Alternatively, for example, rigid strands may be inserted into the ORC fibers. Rigid strands may include tacky surfaces capable of wrapping and/or dipping within ORC fibers. In any event, the rigid strand and ORC fibers can then be inserted into the tube, similar to above, and reheated above the glass transition temperature of the rigid strand. In such cases, the rigid strand may be unconstrained, or at least substantially unconstrained, and may be allowed to return, or at least substantially, to its original, undeformed shape. For example, the rigid strands can contract when returning to their original shape and retract the ORC fibers into the tube. When the rigid tube shrinks, the center of the tube can be clamped to hold the rigid strands and ORC fibers in the center of the tube. Similar to above, the ends of the tube can be sealed to encapsulate the rigid strands and ORC fibers therein.

Referring now to FIG. 244 , a tissue thickness compensator 33320 can include a housing 33326 , a compressible core positioned within the housing 33326 , and a closed end 33328 configured to receive the compressible core within the housing 33326 . Further to the above, housing 33326 can be made by a continuous extrusion process and can include a continuous cross-sectional shape along its length. Referring now to FIGS. 245-247 , a tissue thickness compensator 33420 can include a housing 33426 , a cavity 33424 defined in the housing 33426 , and a core 33425 positioned within the cavity 33424 . For example, the shell 33426 can comprise a film body formed from a continuous extruded shape, and the core 33425 can comprise a fibrous drug core, such as an ORC. The housing 33426 can include one or more flexible legs 33423 capable of extending into the knife slot 22063 defined in the anvil 22060 and releasably retaining the tissue thickness compensator 33420 to the anvil 22060. Referring now to FIGS. 248-250 , a tissue thickness compensator 33520 can include a housing 33526 , a cavity 33524 defined in the housing 33526 , and a core 33425 positioned within the cavity 33524 . For example, the shell 33526 can comprise a film body formed from a continuous extruded shape, and the core 33425 can comprise a fibrous drug core, such as an ORC. Housing 33526 can include one or more retaining members 33528 that can extend around an outer surface of anvil 22060 and that can releasably retain tissue thickness compensator 33520 to anvil 22060 . For example, referring primarily to FIG. 250 , housing 33526 can include movable portions 33527 and a gap 33523 defined between movable portions 33527 , wherein movable portions 33527 can spring apart after tissue thickness compensator 33520 has been separated from anvil 22060 to expose the core 33425 accommodated therein. Referring now to FIGS. 251-252 , a tissue thickness compensator 33620 can include a housing 33626 , a cavity 33424 defined in the housing 33626 , and a core 33425 positioned within the cavity 33424 . For example, the shell 33626 can comprise a film body formed from a continuous extruded shape, and the core 33425 can comprise a fibrous drug core, such as an ORC. The housing 33626 can include a thin section 33623 that can be aligned with the knife slot 22063 defined in the anvil 22060 such that a cutting member passing through the tissue thickness compensator 33620 can pass through the thin section 33623 and reduce the transverse The force or energy required to cut the tissue thickness compensator 33620. Referring now to FIGS. 253-254 , a tissue thickness compensator 33720 can include a housing 33726 , a cavity 33424 defined in the housing 33726 , and a core 33425 positioned within the cavity 33424 . For example, the shell 33726 can comprise a film body formed from a continuous extruded shape, and the core 33425 can comprise a fibrous drug core, such as an ORC. The housing 33726 can include one or more retaining members 33723 that can surround the outer surface of the anvil 22060 and that can releasably retain the tissue thickness compensator 33720 to the anvil 22060 . Referring now to FIGS. 255-256 , a tissue thickness compensator 33820 can include a housing 33826 , a cavity 33424 defined in the housing 33826 , and a core 33425 positioned within the cavity 33424 . For example, the shell 33826 can comprise a film body formed from a continuous extruded shape, and the core 33425 can comprise a fibrous drug core, such as an ORC. For example, housing 33826 can include a substantially rectangular cavity 33424 and a substantially planar tissue-contacting surface 33829 , as compared to the curved cavity 33424 and tissue-contacting surface shown in FIG. 254 . Referring now to FIGS. 257-258 , a tissue thickness compensator 33920 can include a housing 33926 , a plurality of cavities 33924 defined in the housing 33926 , and a core 33925 positioned within each cavity 33924 . For example, the housing 33926 can comprise a film body formed from a continuous extruded shape, and the cores 33925 can each comprise a fibrous drug core, such as an ORC. The core 33925 can be composed of different materials. Housing 33926 can include one or more retaining members 33923 that can extend into knife slot 22063 of anvil 22060 .

Referring now to Fig. 153, a folding process may be utilized to form the tissue thickness compensator. According to the present invention, a material 23525 (eg, oxidized regenerated cellulose) can be placed on a cover sheet 23526 that can be folded and then sealed to enclose the material 23525 . For example, cover sheet 23526 can be composed of, for example, the cytoskeleton-associated protein glycine. A continuous process may be utilized wherein the cover sheet 23526 may pass under a hopper 23592 capable of dispensing the material 23525 onto the cover sheet 23526 . For example, the cover sheet 23526 can be flattened between the roller 23591 and the anvil 23590 before the material 23525 is placed on the cover sheet 23526 . The material 23525 can be placed on one side or half of the cover sheet 23526, wherein the other side or half of the cover sheet 23526 can be folded or turned over onto the material 23525. Cover sheet 23526 may be folded or at least partially folded before, during, and/or after material 23525 has been placed on cover sheet 23526 . The anvil 23590 can include, for example, a cam surface 23594 that can, for example, lift an edge or side of the cover sheet 23526 to be moved longitudinally and subsequently fold the cover sheet 23526 in half. The camming surface 23594 may comprise a three-dimensional or cylindrical cam that progressively lifts and inverts a portion of the cover sheet 23526 as the cover sheet 23526 passes the cam surface 23594 .

After cover sheet 23526 has been folded onto material 23525, folded cover sheet 23526 and material 23525 positioned therein may be passed through die 23593 which may compress and/or compact folded cover sheet 23526 and material 23525 to form tube 23527. The edges of the folded cover sheet 23526 may be sealed using any suitable process, such as heat welding and/or laser welding. The tube 23527 may also be flattened by one or more rollers 23595, for example, before the sidewalls of the tube 23527 have been sealed. The tube 23527 may also be flattened by one or more rollers after the sidewalls of the tube 23527 have been sealed. In any event, the tube 23527 can be divided into sections to create individual tissue thickness compensators. The ends of the tissue thickness compensator may be sealed using any suitable process, such as heat welding and/or laser welding, however alternatively one or both ends of the tissue thickness compensator may remain in the open configuration.

Referring now to FIG. 154, the compensator can be attached to an anvil, eg, anvil 22060, wherein the compensator is capable of storing at least one drug therein. The compensator 23620 can include a central body portion 23626 and a lateral attachment portion 23628 that can be attached to the anvil 22060 . The compensator 23620 can also include an array of capillary channels 23627 defined in the tissue contacting surface 23625 of the compensator 23620, wherein the capillary channels 23627 can store one or more drugs therein. For example, the drug may comprise a fluid that may be held between the side walls of the capillary channel 23627 due to fluid tension. In various cases, the drug can be administered to the compensator 23620 before the compensator 23620 is attached to the anvil 22060, while in some cases, the drug can be administered, for example, after the compensator has been attached to the anvil 22060 to comp 23620. In any event, the compensator 23620 is capable of contacting tissue positioned between the anvil 22060 and the staple cartridge facing away from the anvil 22060, wherein the drug stored in the capillary channel 23627 can flow onto the tissue. In various circumstances, the drug can flow into the capillary channel 23627.

Referring again to the compensator 23620 shown in FIG. 154, the series of capillary channels 23627 can be constructed and arranged in a cross-hatched pattern, wherein a first number of channels 23627 can extend along a first direction and a second number of channels 23627 can extend. Can extend along the second direction. The first number of channels 23627 can intersect and be in fluid communication with the second number of channels 23627 . Referring now to FIG. 155 , a compensator 23920 can include a body 23926 that includes an array of capillary channels 23927 defined in a tissue contacting surface 23925 . Channels 23927 can be defined along linear paths, while channels 23927 can be defined along non-linear paths. For example, a first number of channels 23927 can extend along axis 23923 and a second number of channels 23927 can extend along axis 23924 , wherein axis 23923 can extend in a different direction than axis 23924 . Axis 23923 can be perpendicular, or at least substantially perpendicular, to axis 23924, wherein channels 23627 can define islands 23922 therebetween. For example, the top surface of the island 23922 can define the tissue contacting surface 23925 of the compensator 23920 . The compensator 23920 can include a longitudinal axis 23921 and the channel 23627 can extend in a direction transverse or oblique relative to the longitudinal axis 23921 . Referring again to FIG. 154 , the compensator 23720 can include a body 23726 and a plurality of capillary channels 23727 defined in the body 23726 . The compensator 23720 can also include a longitudinal channel 23721 that can be in fluid communication with the capillary channel 23727 . Optionally, one or more drugs can be stored in the longitudinal channel 23721, where the drugs can flow, for example, between channel 23721 and capillary channel 23727. Channel 23721 can define a longitudinal protrusion that can extend upwardly into a longitudinal knife slot 22061 defined in anvil 22060 .

As noted above, referring again to FIG. 154, the array of capillary channels defined in the compensator may include a cross-hatch pattern. Alternatively, however, the array of capillary channels may comprise any suitable shape or configuration. For example, referring to compensator 23820 shown in FIG. 154 , channels 23827 defined in body 23826 of compensator 23820 can include, for example, parallel, inclined channels that converge toward central channel 23821 and/or away from central channel. 23821 and diverge. Referring now to FIG. 158, the end effector of a surgical stapling instrument can include a staple cartridge 24000 that includes a tissue thickness compensator 24010, wherein the tissue thickness compensator 24010 can include at least one Drugs, for example, Drug 24001. Referring now to FIG. 159 , the compensator 24020 attached to the anvil 24060 can be moved, for example, to a closed position so as to place the compensator 24020 in contact with the tissue thickness compensator 24010 . In such cases, the drug 24001 can be transferred from the tissue thickness compensator 24010 to the compensator 24020, for example. Referring now to FIG. 160 , the compensator 24020 can include a tissue contacting surface 24025 that can contact the tissue thickness compensator 24010 , wherein the drug 24001 can flow into capillary channels 24027 defined in the tissue contacting surface 24025 . Referring now to FIG. 157 , compensator 24020 can include thereon and/or therein at least one medicament, such as medicament 24002 , that is transferable from compensator 24020 to tissue thickness compensator 24010 .

Referring now to FIGS. 240 and 241 , the tissue thickness compensator 33020 can include a plurality of channels and/or wells defined in a surface thereof. The tissue thickness compensator 33020 can include a longitudinal channel 33026 extending along a longitudinal axis defined through the tissue thickness compensator 33020 . For example, an end of the longitudinal channel 33026 can be in fluid communication with the periphery of the tissue thickness compensator 33020 . The tissue thickness compensator 33020 can also include a plurality of wells 33022 and a plurality of angled channels 33024 in fluid communication with the wells 33022 and the longitudinal channel 33026 . The tissue thickness compensator 33020 can also include a plurality of inlet-outlet channels 33027 that can be in fluid communication with the well 33022 and the perimeter of the tissue thickness compensator 33020 . Optionally, as a result of the above, fluid may flow into and/or out of the tissue thickness compensator 33020 before, during, and/or after the tissue thickness compensator has been implanted into the patient's tissue. The pattern of channels 33024, 33026, and 33027 and wells 33022 defined in the tissue contacting surface 33025 of the tissue thickness compensator 33020 can define a gripping edge that can contact tissue and limit the distance between the tissue thickness compensator 33020 and the tissue. slide between. Referring now to FIGS. 240A and 241A , the tissue thickness compensator 33120 can include a plurality of circular channels defined in a surface thereof. The tissue thickness compensator 33120 can include a concentric circular channel 33127 that includes an opening defined in a perimeter of the tissue thickness compensator 33120 . Similar to above, fluid may flow into and/or out of tissue thickness compensator 33120 through channel 33127 . The tissue thickness compensator 33120 can include a concentric circular channel 33122 that can include no openings defined in the perimeter of the tissue thickness compensator 33120 . Referring now to FIGS. 242 and 243 , the tissue thickness compensator 33220 can include a plurality of ridges 33227 extending therefrom that can be configured to grip tissue positioned proximate to the tissue thickness compensator 33220 . For example, the ridge 33227 can be straight or the ridge 33227 can include a curved profile. Although the ridges and channels described above may be used in a tissue thickness compensator, such ridges and channels may be used with any suitable bioabsorbable and/or biocompatible layer.

According to the invention, the compensating element can consist of several layers. For example, the compensator may include a first layer and a second layer attached to the first layer. The first layer can include a tissue contacting surface and a plurality of capillary channels defined in the tissue contacting surface. The first layer may also include capillary channels defined in a side facing the second layer and facing away from the tissue contacting surface. The second layer may include capillary channels defined therein. A well may be defined between the first and second layers of the compensator. Capillary channels may be formed in the layers of the compensator using any suitable method, for example during the molding process forming the layers and/or during the heat staking process. For example, a heat riveting process may be used to attach the layers of the compensator to each other. For example, a layer may be composed of a material that becomes deformable when heat is applied, eg, CAP/GLY (36/64). In any event, the capillary channels defined in the tissue-contacting surface of the compensator can define gripping surfaces therebetween that can improve applicability to tissue positioned between the anvil and the staple cartridge of the surgical stapling instrument. grip and control. In other words, the capillary channels defined on the tissue-contacting surface of the compensator reduce the area over which the compensator can contact tissue. In such cases, a smaller contact area between the compensator and tissue may result in a higher contact pressure for a given force. In each case, higher contact pressure reduces slippage between the compensator and tissue.

Optionally, one or more drugs may be localized within capillary channels and/or voids defined within and/or between the first and second layers. The multiple layers making up the compensator may include a set of therapeutic agent layers or agents. For example, the first layer can be composed of a first drug and the second layer can be composed of a second drug, where the first drug can be different from the second drug. For example, capillary channels defined in the first layer can store a third drug, and capillary channels defined in the second layer can store a fourth drug, wherein the first drug, the second drug, the third drug and/or the fourth drug The drugs may, for example, be different. The first drug, the second drug, the third drug and/or the fourth drug may eg be different. Referring now to FIG. 161 , the compensator 24120 can comprise a plurality of layers, eg, layers 24121-24125. The first layer 24121 and/or the fifth layer 24125 may comprise flat sheets of material that may sandwich the second layer 24122 , the third layer 24123 and/or the fourth layer 24124 . Optionally, one or more of layers 24121-24125 may include one or more channels 24127 defined therein. The channel 24127 can extend from one end of the compensator 24120 to the other end, and the channel 24127 can extend from one side of the compensator 24120 to the other side. Channels 24127 may extend in any suitable direction between any suitable sides and/or ends of compensator 24120 . Referring now to FIGS. 164 and 165 , the compensator 24820 can include, for example, two or more inner layers 24827 that can define transverse channels 24822 that extend from one side of the compensator 24820 to the other. Referring again to FIG. 161 , a channel 24127 defined in one of the layers 24121-24125 can be aligned with a channel defined in a layer positioned adjacent thereto. A channel 24127 defined in one of the layers 24121-24125 may face or open toward a planar surface on the layer positioned adjacent thereto. Referring again to FIG. 161 , one or more of the layers 24121 - 24125 can include at least one well 24129 defined therein. The wells 24129 can be in fluid communication with one or more channels 24127 defined in the layer. Similar to the above, the well 24129 can include an opening facing or facing an adjacent layer, where the adjacent layer can cover the opening.

Further to the above, channels 24127 and/or wells 24129 can contain one or more drugs therein. Channel 24127 can include one or more open ends that can allow drug to flow out of channel 24127. Similarly, channel 24127 may include one or more openings capable of allowing fluid (eg, blood) to flow into channel 24127 . In such cases, the fluid may flow into the compensator 24120, absorb the drug and/or at least a portion of the layers 24121-24125, and then flow out of the compensator 24120. Referring again to FIGS. 164 and 165 , the compensator 24820 can include apertures 24828 defined in the outer layer 24826 , for example. Referring again to FIG. 161, layers 24121-24125 may be composed of any suitable material, for example, bioabsorbable polymers, PLA, and/or PGA. All of the layers 24121-24125 may be composed of the same material. Alternatively, one or more of the layers 24121-24125 may be composed of different materials. Optionally, one or more of the layers 24121-24125 may include a through-hole 24128 extending therethrough, for example, capable of allowing fluid, such as blood, to flow into the channel 24127, into the well 24126, and/or Between two or more of layers 24121-21135. One or more of the layers 24121-24125 may be joined to each other using, for example, thermal welding and/or laser welding processes. In such cases, the fluid flowing into the compensator 24120 may dissolve the welded portion of the layers 24121-24125 and allow the layers 24121-24125 to separate and/or peel off. One or more of the layers 24121-24125 may be composed of a material that dissolves at a faster and/or slower rate than the materials making up the other layers 24121-24125. For example, the inner layers 24122-24124 of the compensator 24120 may be composed of a material that dissolves at a faster rate than the material comprising the outer layers 24121 and 24125, for example. In such cases, the compensator 24120 can maintain a consistent, or at least substantially consistent, overall shape as the interior of the compensator 24120 is dissolved away. The outermost layer of the compensator may be composed of a material which dissolves at a faster rate than the material making up the innermost layer of the compensator, for example. For example, a layer may comprise a sheet of material having a thickness between about 1 mil and about 4 mils.

Referring now to FIGS. 162 and 163 , a compensator such as compensator 24220 can include a support layer 24226 that can be attached to an anvil (eg, anvil 22060 ) and/or a staple cartridge. The compensator 24220 can also include a bracket 24222 attached to a support layer 24226, wherein the bracket 24222 can include a plurality of bracket layers 24227. Scaffolds can include, for example, three-dimensional structured matrices. Optionally, each of the scaffold layers 24227 may be comprised of a plurality of fibers. Referring now to FIG. 166, each scaffold layer 24227 can be comprised of a braid of fibers comprising a first plurality of fibers 24228 extending in a first direction and a second plurality of fibers 24229 extending in a second or different direction. Each fiber braid can include a plurality of dimples or cavities 24223, wherein layers 24227, fibers 24228, 24229, and cavities 24223 can define a matrix that facilitates tissue and cell ingrowth. Fibers 24228, 24229, and/or any other suitable fibers may be comprised of bioabsorbable materials. Fibers may be composed of, for example, hemostatic agents, binding active agents (eg, those that are biologically and/or pharmacologically active), and/or support members (which may be interwoven with each other). In any event, the material of the fibers can be selected to result in a desired biological response, eg, migration of cells into scaffold 24222, secretion of ECM, and/or proliferation of structured support cells.

Further to the above, the support layer 24226 is capable of structurally supporting the bracket 24222 . The stent 24222 can be attached to the support layer 24226, for example, using one or more bioabsorbable adhesives. Similarly, the support layer 24226 can be attached to the anvil or staple cartridge using, for example, one or more biocompatible adhesives. Layers 24227 of stent 24222 may be arranged or stacked in any suitable manner. Each layer 24227 can include a pattern of fibers, wherein the layers 24227 can be arranged in the support 24222 such that the patterns of the layers 24227 are aligned with each other. Referring to FIG. 167 , the layers 24227 can be stacked on top of each other such that the fibers 24228 in the first layer 24227 are aligned with the fibers 24228 in the second layer 24227 . Likewise, the layers 24227 can be stacked on top of each other such that the fibers 24229 in the first layer 24227 are aligned with the fibers 24229 in the second layer 24227 . Referring now to FIG. 168, a scaffold 24422 can include a plurality of scaffold layers 24427, wherein the fibers 24429 in each scaffold layer 24427 are oriented in the same direction, eg, a longitudinal direction. Referring now to FIG. 170, each scaffold layer 24227 can comprise a pattern of fibers, wherein the layers 24227 can be arranged in the scaffold 24322 such that the patterns of layers 24227 are not aligned with each other. The layers 24227 may be stacked on top of each other such that the fibers 24228 in the first layer 24227 extend in a direction transverse or diagonal to the fibers 24228 in the second layer 24227 . Likewise, the layers 24227 may be stacked on top of each other such that the fibers 24229 in a first layer 24227 extend in a direction transverse or diagonal to the fibers 24229 in a second layer 24227 . Referring now to FIG. 171 , a scaffold 24522 can include, for example, a plurality of scaffold layers 24427 oriented such that the fibers 24229 in each scaffold layer 24427 are oriented in different directions.

Further to the above, the first stent layer 24227 of the stent 24222 can be composed of a first material, and the second stent layer 24227 of the stent 24222 can be composed of a second or different material, for example. For example, a first material may include a first drug, while a second material may include a second or different drug. To further describe the above, for example, the first stent layer 24227 of the stent 24222 can include, for example, a first drug absorbed into its fibers, and the second stent layer 24227 of the stent 24222 can include a first drug absorbed into its fibers. Two or different medicines. For example, a first material may include a first drug, while a second material may include a second or different drug. A scaffold may comprise any suitable number of layers having any suitable density of fibers comprised of any suitable number of materials.

The holder may be utilized to mount the tissue thickness compensator in a surgical device (eg, a surgical cutting and stapling device). The retainer can include a gripping surface and allow a surgeon, nurse, technician, or other personnel to align one or more of the tissue thickness compensators with features of the surgical instrument (eg, an anvil and/or staple cartridge). The retainer can include features to align the one or more tissue thickness compensators by engaging the staple cartridge of the surgical instrument. The retainer may include features to align the one or more tissue thickness compensators by engaging the anvil of the surgical instrument. A staple cartridge for the surgical instrument can be included with the retainer, and engaging the retainer with the surgical instrument can install the staple cartridge in the surgical instrument and can align one or more of the tissue thickness compensators. After the tissue thickness compensator has been aligned and attached to the surgical instrument, the retainer can be detached from the tissue thickness compensator and subsequently removed from the surgical instrument.

61-67 illustrate an embodiment of a retainer 19000 that may be used, for example, to attach a first tissue thickness compensator 19002 to an anvil 19040 and a second tissue thickness compensator 19004 to a staple cartridge 19050 of a surgical stapler . A retainer assembly 19060 comprising a retainer 19000, a first tissue thickness compensator 19002, and a second tissue thickness compensator 19004 can be provided. Generally, the retainer assembly 19060 can be inserted between the anvil 19040 and a channel capable of supporting the staple cartridge 19050 during use. Then, the anvil 19040 can be closed. By closing the anvil 19040 , the anvil 19040 can be pushed down onto the first tissue thickness compensator 19002 such that the first tissue thickness compensator 19002 can be attached to the anvil 19040 . Closing anvil 19040 pushes retainer 19000 downward and disposes staple cartridge 19050 within the channel of the surgical instrument. When the anvil 19040 is reopened, the first tissue thickness compensator 19002 can be separated from the retainer 19000 and the retainer 19000 can be separated from the second tissue thickness compensator 19004 when the retainer 19000 is subsequently removed from the surgical device. The surgical device is then ready for use with the first tissue thickness compensator 19002 attached to the anvil 19040 and the second tissue thickness compensator 19004 attached to the staple cartridge 19050.

Referring to FIG. 61 , the holder 19000 can include a grip 19014 that allows a person preparing the surgical instrument (eg, a surgeon, nurse, or technician) to grasp the holder 19000 . The retainer 19000 can include a first surface 19001 on which the first tissue thickness compensator 19002 can be positioned and an opposing second surface 19003 on which the second tissue thickness compensator 19004 can be positioned. Optionally, one or more adhesives may be applied to first surface 19001 and/or second surface 19003 for attaching first tissue thickness compensator 19002 and second tissue thickness compensator 19004 thereto . The retainer 19000 can also include, for example, a clip that can engage the staple cartridge 19050 of the surgical device. Referring to FIG. 64 , the retainer 19000 can include a distal clip 19108 configured to engage a groove 19056 at a distal end of the staple cartridge 19050 and/or a proximal clip 19106 configured to engage a ridge or edge 19054 on the staple cartridge 19050 .

Referring to FIG. 61 , a first tissue thickness compensator 19002 can include a retainer-facing surface 19006 and an anvil-facing surface 19010 . The holder-facing surface 19006 may be attached to the first surface 19001 of the holder 19000 by, for example, an adhesive and/or an engaging feature. The anvil-facing surface 19010 can include thereon at least one adhesive that can attach the first tissue thickness compensator 19002 to the anvil 19040 of the surgical device. For example, the adhesive can comprise an activatable adhesive that can be attached to the staple forming surface 19044 of the anvil 19040 (FIG. 63).

Referring to FIGS. 61 and 63-66 , the anvil-facing surface 19010 of the first tissue thickness compensator can include engagement features 19020 that engage similar engagement features 19042 on the anvil 19040 . Thus, a first retention force can retain first tissue thickness compensator 19002 to retainer 19000 and a second retention force can retain first tissue thickness compensator 19002 to anvil 19040 . The second retaining force can be greater than the first retaining force such that the first tissue thickness compensator 19002 can remain attached to the anvil 19040 and can be detached from the retainer 19000 when the retainer 19000 is removed from the end effector.

Referring again to FIG. 61 , the second tissue thickness compensator 19004 can include a retainer-facing surface 19008 and a cartridge-facing surface 19012 . The holder-facing surface 19006 may be attached to the first surface 19001 of the holder 19000 by one or more adhesives and/or engagement features. The cartridge-facing surface 19012 can include an adhesive thereon that can attach the second tissue thickness compensator 19004 to the staple cartridge 19050 of the surgical device. For example, referring to FIG. 64 , an adhesive can attach the second tissue thickness compensator 19004 to the staple deck 19052 of the staple cartridge 19050 . Cartridge-facing surface 19012 can also include engagement features that engage cooperating engagement features on staple cartridge 19050 . Accordingly, the first retention force can retain the second tissue thickness compensator 19004 to the retainer 19000 and the second retention force can retain the second tissue thickness compensator 19004 to the staple cartridge 19050 . The second retaining force can be greater than the first retaining force such that the second tissue thickness compensator 19004 can remain attached to the staple cartridge 19050 and can be detached from the retainer 19000 when the retainer 19000 is removed from the end effector.

As shown in FIG. 64, the retainer assembly 19060 can be attached to the staple cartridge 19050 in the manner indicated by arrow A. As described above, the distal clips 19018 on the retainer 19000 can engage the grooves 19056 in the staple cartridge and the proximal clips 19016 on the retainer can engage the edges or ridges 19054 on the staple cartridge 19050 . At this point, retainer 19000 is attached to staple cartridge 19050 as shown in FIG. 65 , and second tissue thickness compensator 19004 can be attached to staple cartridge 19050 . As shown in FIG. 66 , closure of the anvil 19040 of the surgical device in the direction of arrow B can bring a surface 19044 (eg, a staple forming surface and/or a tissue contacting surface) of the anvil into contact with the first tissue thickness compensator 19002 . Contacting the anvil 19040 of the first tissue thickness compensator 19002 can cause the first tissue thickness compensator 19002 to attach to the anvil 19040, as described above.

After the retainer assembly 19060 has been attached to the staple cartridge 19050 and the anvil 19040 has been closed, the first tissue thickness compensator 19002 can be attached to the anvil 19040 and the second tissue thickness compensator 19004 can be attached to the staples Bin 19050. As described above, the retaining force to retain the first tissue thickness compensator 19002 to the retainer 19000 can be less than the retaining force to retain the first tissue thickness compensator 19002 to the anvil 19040 . Accordingly, when the anvil 19040 is reopened, the first tissue thickness compensator 19002 can be separated from the retainer 19000 and can remain with the anvil 19040, as shown in FIG. 67 . Also as described above, the retaining force to retain the second tissue thickness compensator 19004 to the retainer 19000 can be less than the retaining force to retain the first tissue thickness compensator 19004 to the staple cartridge 19050 . Accordingly, when the retainer 19000 is removed in the direction of arrows C and D shown in FIG. 67 , the retainer 19000 can be separated from the second tissue thickness compensator 19004 . The surgical stapler shown in FIG. 67 includes a first tissue thickness compensator 19002 attached to an anvil 19040 and a second tissue thickness compensator 19004 attached to a staple cartridge 19050 and is ready for use.

390-396 illustrate retainer 19000 being used with first tissue thickness compensator 19002 and second tissue thickness compensator 19004. The retainer 19000 may also be used with only one of the first tissue thickness compensator 19002 and the second tissue thickness compensator 19004. For example, the first tissue thickness compensator 19002 can be omitted.

68-70 illustrate an embodiment of a retainer 19100 that can include engagement features 19108 on a surface 19101 . As shown in FIGS. 69 and 70 , engagement features 19108 on retainer 19100 engage cooperating engagement features 19109 on first tissue thickness compensator 19102 .

71 and 72 illustrate an embodiment of a retainer 19200 that can include a surface 19202 capable of aligning and attaching a tissue thickness compensator 19210 to an anvil 19230 . Retainer 19200 can include alignment pegs 19204 extending from surface 19202 . The retainer 19200 shown in FIGS. 71 and 72 includes four alignment pegs 19204 , although more or fewer alignment pegs 19204 may be provided. Referring to FIG. 72 , a tissue thickness compensator 19210 can include a body 19212 that includes an aperture 19216 that can be positioned such that it corresponds to the location of an alignment peg 19204 extending from the retainer 19200 . Each aperture 19216 in the tissue thickness compensator 19210 fits over the alignment peg 19204, and due to the tight fit between the aperture 19216 and the peg 19204, the tissue thickness compensator 19210 can be aligned with the retainer 19200. Optionally, each cavity 19216 may be slightly smaller than its corresponding peg 19204 such that each cavity 19216 expands when placed over its peg 19204 . This expansion can retain the aperture 19216 on the plug 19204. Each aperture 19216 can include an adhesive therein to create a releasable bond between the plug 19204 and the tissue thickness compensator 19210.

The tissue thickness compensator 19220 can include a tab 19220 extending from a body 19212 of the tissue thickness compensator 19220 that can be received by a slot 19234 in an anvil 19230 . Slots 19234 in anvil 19230 can be positioned in staple forming surface 19232, for example. After the retainer 19200 has been attached to the staple cartridge, the anvil 19230 can be closed against the tissue thickness compensator 19210 on the retainer 19200, similar to above. When the anvil 19230 is closed, referring to FIG. 72 , the tabs 19220 on the tissue thickness compensator 19210 can engage the slots 19234 , thereby attaching the tissue thickness compensator 19210 to the anvil 19230 . Referring primarily to FIG. 71 , each tab 19220 can include a tapered portion 19222 that guides the tab 19220 into a slot 19234 of the anvil 19230 . Tapered portion 19222 may include sloped walls and may have a cross-sectional area that increases along its length. The base portion 19226 of each tab 19220 can have a cross-sectional area that is less than the largest cross-sectional area of the tapered portion 19222 . The tapered portion 19222 can include a locking surface 19224 , wherein the locking surface 19224 can snap onto the lip 19235 of the slot 19234 when the tab 19220 enters the slot 19234 . Thus, locking surface 19224 can retain tab 19220 within slot 19234 , thereby retaining tissue thickness compensator 19210 to anvil 19230 . Slots 19228 defined in tissue thickness compensator 19210 and extending between tabs 19220 may allow tabs 19220 to flex inwardly and fit within slots 19234 . The tab 19220 being retained with the slot 19234 can define a first retention force holding the tissue thickness compensator 19210 to the anvil 19230, and the aperture 19216 in the tissue thickness compensator 19210 being retained on the peg 19204 can define a second retention force. Retentivity. The first retaining force can be greater than the second retaining force such that the first tissue thickness compensator 19210 can remain attached to the anvil 19230 and can be detached from the retainer 19200 when the retainer 19200 is removed from the end effector.

The body 19212 of the tissue thickness compensator 19210 of FIGS. 71 and 72 can also define a slot 19214 therein. The slots 19214 can be aligned along the longitudinal axis of the tissue thickness compensator 19210 . For example, the slot 19214 can be arranged on the longitudinal axis such that when the tissue thickness compensator 19210 is attached to the anvil 19230, the slot 19214 is aligned with the longitudinal path of the cutting blade of the surgical device. The slots 19214 can reduce the amount of energy required for the cutter to cut through the tissue thickness compensator 19210 .

73-83 illustrate an embodiment of a retainer 19300 that includes a clip 19310 configured to retain a tissue thickness compensator 19340 on a first surface 19302 of the retainer 19300 . When the anvil 19360 is closed over the retainer 19300, the anvil 19360 can push and move the clamp 19310 outwardly and thereby disengage the retainer 19300 from the tissue thickness compensator 19340, similar to above. When the anvil 19360 is reopened, the anvil 19360 is pressed against the tissue thickness compensator 19340 and moves away from the retainer 19300, thereby allowing the tissue thickness compensator 19340 to be attached to the anvil 19360.

Retainer 19300 can include cartridge mounting jigs 19312 and 19314, which can be similar to those described above with respect to FIGS. 61-70. In addition to the first surface 19302 described above, the retainer 19300 can also include a second surface 19304 capable of carrying a second tissue thickness compensator. Second surface 19304 may include alignment structures, eg, raised ridges 19308 . Raised ridges 19308 can engage slots in the second tissue thickness compensator and/or slots in staple cartridge 19370, for example.

75-77 , during use, retainer 19300 can be attached to staple cartridge 19370 by clamps 19314 and 19312 . The first tissue thickness compensator 19340 can be positioned on the first surface 19302 at the holder 19300 and can be held fixed by the clamp 19310 . Referring primarily to FIGS. 81-83 , each clamp includes a flat member 19313 that can clamp a first tissue thickness compensator 19340 against a first surface 19302 of the retainer 19300 . Each clip 19310 can include an inwardly facing tapered or curved surface 19311. When the anvil 19360 is moved in the direction of arrow E, see FIG. 82 , the edge 19366 of the anvil 19360 can contact the inwardly facing curved surface 19311 of the clamp 19310 . As the anvil 19360 continues to move in the direction of arrow E, interference between the edge 19366 of the anvil 19360 and the curved surface 19311 of the clamp 19310 may push the clamp 19310 outward in the direction of arrow F, as shown in FIG. 82 . When the clamp 19310 is moved in the direction of arrow F, the first tissue thickness compensator 19340 is released from the flat piece 19313 of the clamp 19310 .

As anvil 19360 continues to move in the direction of arrow E, it also contacts and attaches to tissue thickness compensator 19340. For example, when anvil 19360 is moved in the direction of arrow E, engagement features (eg, raised ridges 19344 ) on tissue thickness compensator 19340 engage channels 19364 in anvil 19360 . Raised ridge 19344 can have an interference fit with channel 19364 such that tissue thickness compensator 19340 is attached to anvil 19360 . The tissue thickness compensator 19340 can include an adhesive attached to the surface of the anvil 19360. Raised ridge 19344 may include an adhesive that adheres to the surface of channel 19364 . Likewise, the surface of the body 19342 of the tissue thickness compensator 19340 can include an adhesive that adheres to the surface 19362 of the anvil 19360 . After the tissue thickness compensator 19340 is attached to the anvil 19360, when the anvil 19360 returns to its open position by moving in the direction of arrow G, as shown in FIG. Lifts and can be held together with anvil 19360.

FIG. 84 shows a cut-away side view of an embodiment of a retainer 19400. A first tissue thickness compensator 19410 is positioned on a first side 19402 of the holder 19400 and a second tissue thickness compensator 19420 is positioned on a second side 19404 of the holder 19400 . The retainer 19400 defines one or more apertures 19406 extending therethrough. The first tissue thickness compensator 19410 and the second tissue thickness compensator 19420 are connected by a connector 19430 extending through the aperture 19406 and passing through the aperture. The first tissue thickness compensator 19410, the second tissue thickness compensator 19420, and the connector 19430 can all be formed from a single material. For example, the first tissue thickness compensator 19410 , the second tissue thickness compensator 19420 , and the connector 19430 can be overmolded onto the retainer 19400 . Alternatively, connector 19430 may be formed as part of one of the tissue thickness compensators (eg, first tissue thickness compensator 19410). Connector 19430 can pass through aperture 19406 and then attach to the remaining tissue thickness compensator, eg, second tissue thickness compensator 19420 . The connector 19430 can be attached to the second tissue thickness compensator 19430, for example, by utilizing an adhesive or by an interference fit between an end of the connector and a receiving port (not shown) in the second tissue thickness compensator 19420 19420. Connector 19430 can be a separate component that is placed within aperture 19406 and can be received in first tissue thickness compensator 19410 and second tissue thickness compensator 19420 by, for example, using an adhesive or an end of connector 19430 The interference fit between the ports is used to attach to the first tissue thickness compensator 19410 and the second tissue thickness compensator 19410.

After the retainer 19400 has been placed on the staple cartridge 19450, for example, the anvil block 19440 of the surgical device can be moved in the direction of arrow H to the closed position. The adhesive and/or engagement features on the surface 19414 of the first tissue thickness compensator 19410 can attach the first tissue thickness compensator 19410 to the anvil 19440 when the anvil 19440 is closed. Likewise, adhesive and/or engagement features on the surface 19424 of the second tissue thickness compensator 19420 can attach the second tissue thickness compensator 19420 to the staple cartridge 19450 . After the anvil 19440 is closed and the first tissue thickness compensator 19410 and the second tissue thickness compensator 19420 are attached to the anvil 19440 and the staple cartridge 19450, respectively, the retainer 19400 can be pulled in the direction of arrow 1 (FIG. 88) To remove the retainer 19400 from between the first tissue thickness compensator 19410 and the second tissue thickness compensator 19420 and break the connector 19430. As shown in FIG. 89 , after the connector 19430 is broken and the retainer 19400 has been removed, the anvil 19440 can be reopened and the first tissue thickness compensator 19410 will be attached to the anvil 19440 and the second tissue thickness compensator 19420 will be attached. Will attach to cartridge 19450.

According to the present invention, the proximal portion 19407 of each hole 19406 in the retainer 19400 can include a cutting edge. When the retainer is pulled in the direction of arrow 1 (FIG. 88), a pulling force is transmitted through the proximal portion 19407 of the aperture 19406 to break the connector. The cutting edge at the proximal portion 19407 of each hole 19406 concentrates the transmitted force on a relatively small area of each link. Accordingly, the connectors will break more easily and less pulling force may be required to remove the retainer 19400 from between the first tissue thickness compensator 19410 and the second tissue thickness compensator 19420 .

As described above, the retainer assembly may include a retainer positioned between the first tissue thickness compensator and the second tissue thickness compensator, wherein the When the retainer is in place, the retainer can be pulled from between the tissue thickness compensators and can be removed from the end effector. The retainer can provide a barrier between the first tissue thickness compensator and the second tissue thickness compensator. Once the retainer is removed from between the first tissue thickness compensator and the second tissue thickness compensator, the substance in and/or on the first tissue thickness compensator can be neutralized, for example, with the second tissue thickness compensator. / or react with substances above. One or both of the tissue thickness compensators may include a membrane that may encapsulate a substance within the tissue thickness compensator. The membrane can be attached to the retainer, wherein when the retainer is pulled from between the tissue thickness compensators, as described above, the retainer can pull the membrane away from the tissue thickness compensator to expose the substance contained therein. At this point, the substances within each tissue thickness compensator can interact with each other.

90-100 illustrate an embodiment of a retainer engaging an anvil of a surgical device (eg, a surgical stapler). The retainer can align the first tissue thickness compensator with the anvil and align the second tissue thickness compensator with the staple cartridge. Closing the anvil causes the first tissue thickness compensator to be attached to the anvil and causes the second tissue thickness compensator to be attached to the staple cartridge. The retainer can also carry a staple cartridge, with a tissue thickness compensator optionally disposed between the retainer and the staple cartridge. Closing the anvil causes the staple cartridge to attach to the channel of the surgical stapler and causes the first tissue thickness compensator to attach to the anvil.

90-93 illustrate an embodiment of a retainer 19500. The holder 19500 includes grips 19502 that allow a surgeon, nurse, technician, or other person to manipulate the holder 19500. Grip 19502 can include a textured surface, such as raised portions 19503, that can provide a better gripping surface. The retainer 19500 can include a surface 19504 on which the tissue thickness compensator can be mounted. Surface 19504 can include one or more protrusions 19506 , wherein protrusions 19506 can engage grooves in the tissue thickness compensator and align the tissue thickness compensator relative to surface 19504 of retainer 19500 . The grooves in the tissue thickness compensator can be slightly smaller than the protrusions 19506 such that the protrusions 19506 can hold the tissue thickness compensator to the surface 19504 when engaged with the grooves. Protrusions 19506 can pass through holes in the tissue thickness compensator and engage slots (eg, cutter slots 19558 in anvil 19550 shown in FIG. 95 ), thereby aligning the tissue thickness compensator with retainer 19500 and providing Additional alignment of the retainer 19500 with the anvil 19550. Tissue thickness compensator 19540 can include adhesive and/or engagement features on surface 19542 as described above for attaching the tissue thickness compensator to anvil 19550 .

As shown in FIG. 94a, a staple cartridge 19530 can be attached to the retainer 19500. Staple cartridge 19530 can be attached to retainer 19500 by clips 19510 and 19512 extending from retainer 19500 . Clips 19512 on retainer 19500 can engage slots 19534 in staple cartridge 19530 . The jaws 19510 of the retainer 19500 can surround the bottom 19532 of the staple cartridge 19532. A second tissue thickness compensator can be attached to staple cartridge 19530 in accordance with the present invention. A second tissue thickness compensator can be attached to the staple platform 19536 of the staple cartridge 19530.

95 and 96, the retainer assembly 19590 comprising the retainer 19500, the tissue thickness compensator 19540, and the staple cartridge 19530 can be slid in the direction of arrow L onto the anvil of a surgical device (e.g., a surgical stapler) 19550 on. Guide tabs 19508 on retainer 19500 can surround edge 19552 of anvil 19550 and position retainer assembly 19590 relative to anvil 19550 . After the retainer assembly 19590 is engaged on the anvil 19550, the anvil can be closed in the direction of arrow M as shown in FIGS. 97 and 98 . Closure of the anvil 19550 can position the staple cartridge 19530 in the channel 19560 of the surgical device. Closure of the anvil 19550 can cause the clip 19510 extending from the retainer 19500 to engage the ridge 19562 of the channel 19560 to securely position the staple cartridge 19530 in the channel 19560. When the anvil 19550 is reopened in the direction of arrow N, referring now to FIGS. 99 and 100 , the tissue thickness compensator 19540 can remain attached to the anvil 19550 and detached from the retainer 19500 . The retainer 19500 can then be removed from the surgical instrument in the direction of arrow O ( FIGS. 99 and 100 ), leaving the staple cartridge 19530 in the channel 19560 of the surgical device and the tissue thickness compensator attached to the anvil 19550 19540.

101 and 102 illustrate examples of two alternative embodiments of tissue thickness compensators 19570 and 19580, respectively. 101 is a cross-sectional view of a tissue thickness compensator 19570 attached to a retainer 19501, wherein the tissue thickness compensator 19570 can include a protrusion 19574 that can contact the edge 19552 of the anvil 19550 and partially surround the exterior of the anvil 19550 Surface 19556. The protrusions can grip the anvil 19550 and/or can be attached to the anvil 19550 using one or more adhesives. To release the tissue thickness compensator 19570 from the anvil 19550 after the compensator 19570 has been implanted against the tissue of the patient, the protrusions 19574 can flex outwardly from the anvil 19550, thereby allowing the tissue thickness compensator 19570 to be pulled away from the anvil 19550. FIG. 102 is a cross-sectional view of a tissue thickness compensator 19580 attached to the retainer 19501 shown in FIG. 101 . The tissue thickness compensator 19580 includes a sleeve 19584 that can surround the anvil 19550 to align the tissue thickness compensator 19580 with the anvil 19550 and/or retain the tissue thickness compensator 19580 on the anvil 19550 . The socket 19584 can retain the tissue thickness compensator 19580 on the anvil 19550 . To separate the socket 19584 from the anvil 19550, the tissue thickness compensator 19580 can be torn away from the socket 19584, for example, at the perforation 19586. Thus, the socket 19584 can remain on the anvil 19550, while the remainder of the tissue thickness compensator 19580 can remain sutured to the patient's tissue.

A tissue thickness compensator (eg, tissue thickness compensator 19570) can include an inner portion that includes a biocompatible substance positioned therein. Biocompatible substances may include, for example, anti-inflammatory agents, coagulants, and/or antibiotics. According to the present invention, a body such as a wafer may be inserted into the inner portion within the tissue thickness compensator. For example, a wafer may be inserted through the open end of the tissue thickness compensator into the cavity defined therein. The wafer can be retained within the cavity of the tissue thickness compensator by an interference fit. The step for assembling the wafer into the tissue thickness compensator may include a first step of heating the tissue thickness compensator to expand the tissue thickness compensator. As the tissue thickness compensator expands, the lumen defined therein may also expand. When the tissue thickness compensator is in the expanded state, according to a second step, a wafer can be inserted into the cavity. Then, as the tissue thickness compensator cools, according to a third step, the cavity may shrink onto the wafer and hold the wafer in place within the cavity.

103-115 illustrate an embodiment of a holder including a separate insertion tool. An insertion tool may be used to insert the assembly into a surgical instrument such as a surgical stapler. The insertion tool may also compress the staple cartridge and one or more tissue thickness compensators of the retainer assembly into place within the surgical instrument. Referring to FIGS. 103 and 104 , the holder 19600 can include a first plate 19620 and a second plate 19622 . The first plate 19620 and the second plate 19622 may be connected by a hinge 19612 . The hinge 19612 can position the first plate 19620 at an angle relative to the second plate 19622 and can also allow the first plate 19620 to rotate about the hinge 19612 relative to the second plate 19622 .

The first plate 19620 can include an outward facing surface 19604 and an inward facing surface 19606 . Likewise, the second plate 19622 can include an outwardly facing surface 19610 and an inwardly facing surface 19608 . Inwardly facing surface 19606 of first plate 19620 can include cam protrusions 19614 . Similarly, the inward facing surface 19608 of the second plate 19622 can include camming protrusions 19616 . 110-115, the outward facing surface 19604 of the first plate can include a tissue thickness compensator positioned thereon. The outward facing surface 19601 of the second plate 19622 can also include a tissue thickness compensator positioned thereon. The tissue thickness compensator can be attached to the outer surfaces 19604 and 19610, for example, using adhesives, engagement features, and/or other suitable attachment means. The retainer 19600 can include a clip 19618 extending from the second plate 19622 configured to engage the staple cartridge 19690, as shown in Figure 110 and Figures 112-115.

Referring now to FIGS. 105-109 , an insertion tool 19630 can include a first end 19632 and a second end 19634 . The first end 19632 can be large enough for a surgeon, nurse, and/or technician to grasp, for example. The second end 19634 defines a cavity 19640, wherein the cavity can include a cam 19648 positioned therein. The first side of the cam 19648 can include a first protrusion 19642, a second protrusion 19644, and a first lower recess 19646 positioned therebetween. The second side of the cam 19648 can include a third protrusion 19643, a fourth protrusion 19645, and a second lower recess 19647 positioned therebetween. For example, protrusions and depressions may be arranged in a mirror image. In other words, the first protrusion 19642 can be disposed on the first side of the cam 19648 opposite the third protrusion 19643 on the second side of the cam 19648 . Likewise, the second protrusion 19644 can be positioned on the first side of the cam 19648 opposite the fourth protrusion 19645 on the second side of the cam 19648 . Additionally, the first lowered recess 19464 can be disposed on the first side of the cam 19648 opposite the second lowered recess 19647 on the second side of the cam 19648 .

During use, the second end 19634 of the insertion tool 19630 can be placed between the first plate 19620 and the second plate 19622 of the holder 19600 such that, for example, the cam protrusion 19614 on the first plate 19620 engages the lower recess 19646 and makes the Cam protrusions 19616 on second plate 19622 engage lower recesses 19647 . As shown in FIGS. 112 and 113 , an insertion assembly 19700 comprising a retainer 19600 , an insertion tool 19630 , one or more tissue thickness compensators, and a staple cartridge 19690 can be inserted into a surgical instrument. A surgical instrument (eg, a surgical stapler) can include an anvil 19720 and a channel 19740 configured to receive a staple cartridge 19690 . Insertion assembly 19700 can be inserted into the surgical instrument in the direction of arrow P ( FIG. 113 ) to lock staple cartridge 19690 within channel 19740 . In this position, cams 19614 and 19616 may align with lower recesses 19646 and 19647, respectively.

After staple cartridge 19690 is locked within channel 19740, insertion tool 19600 may continue to move in the direction of arrow Q relative to the surgical instrument, as shown in FIG. 114 . Further movement of the insertion tool 19600 in the direction of arrow Q can align the first protrusion 19642 with the first cam protrusion 19614 and align the third protrusion 19634 with the second cam protrusion 19616 . This alignment can cause retainer plates 19620 and 19622 to rotate away from each other about hinge 19612 in the direction of arrow R ( FIG. 114 ). In such circumstances, the retainer plate 19620 and tissue thickness compensator 19670 can be moved toward the anvil 19720 , and the retainer plate 19622 can be moved toward and contact the anvil 19720 . Optionally, tissue thickness compensator 19670 can be placed on anvil 19720 as described above. After the tissue thickness compensator 19670 is attached to the anvil 19720, the insertion tool 19630 can be retracted or moved in the direction of arrow S (shown in FIG. 115). Movement of the insertion tool 19630 in the direction of arrow S may cause the cam protrusions 19614 and 19616 to disengage from the first protrusion 19642 and the third protrusion 19643, respectively, and become re-aligned with the first lower recess 19646 and second lower recess 19647, respectively . The second protrusion 19642 and the fourth protrusion 19645 may abut the cam protrusions 19614 and 19616 , respectively, and may prevent the insertion tool 19630 from being completely separated from the holder 19600 . With the cam protrusions 19614 and 19616 aligned with the lower recesses 19646 and 19647 again, the first plate 19620 can rotate about the hinge 19612 at least partially toward the second plate 19622 and away from the anvil 19720 . Retainer 19600 can also be detached from channel 19740 and then removed in the direction of arrow S, leaving tissue thickness compensator 19670 attached to anvil 19720, for example.

As described herein, a retainer assembly can be used to mount one or more tissue thickness compensators within an end effector of a surgical stapling instrument. The retainer assembly can mount layers other than the tissue thickness compensator into the surgical instrument. Layers may include, for example, absorbable and/or biocompatible materials.

Referring to FIG. 172 , the end effector 12 can receive an end effector insert 25002 . The end effector 12 may include a lower jaw 25070 and an anvil 25060 pivotable relative to the lower jaw 25070 . End effector insert 25002 can include a staple cartridge 25000 pivotably connected to anvil insert 25004. End effector 12 can receive end effector insert 25002 such that staple cartridge 25000 fits within staple cartridge channel 25072 of, for example, lower jaw 25070 and such that anvil insert 25004 contacts, for example, anvil 25060 . Lower jaw 25070 can include a plurality of securing members 25074 configured to secure staple cartridge 25000 to staple cartridge channel 25072. Anvil insert 25004 can include at least one retention protrusion configured to engage at least one retention groove in anvil 25060 . Anvil insert 25004 is capable of correspondingly pivoting toward staple cartridge 25000 as anvil 25060 pivots toward lower jaw 25070, as described in greater detail herein.

Still referring to FIG. 172 , the end effector insert 25002 can also include a retainer 25010 . Retainer 25010 can securely engage at least one of staple cartridge 25000 and anvil insert 25004. Retainer 25010 can include at least one securing clip 25012 that can clamp, engage, snap, clamp, and/or hook staple cartridge 25000 . As shown in FIG. 172, the retainer 25010 may include, for example, two securing clips 25012 on each longitudinal side thereof. For example, retaining clip 25012 can be clamped over a portion of staple cartridge 25000, for example. In accordance with the present invention, the tissue thickness compensator can be held fixed relative to the end effector insert 25002 by the retainer 25010 . For example, a tissue thickness compensator can be positioned between retainer 25010 and staple cartridge 25000 .

Optionally, retainer 25010 may provide a solid or substantially solid element for the operator to grasp while the operator is inserting end effector insert 25002 into end effector 12 . In addition, retainer 25010 can resist premature deformation of a tissue thickness compensator defined by retainer 25010, for example. Retainer 25010 may be removed from end effector 12 prior to cutting and/or fastening tissue with end effector 12 . Alternatively, retainer 25010 may remain positioned in end effector 12 . For example, when staples are fired from the lumen 25002 (FIG. 207) of the staple cartridge 25000, the retainer 25010 can be transected by the cutting element 25052 (FIG. 207). Retainer 25010 may comprise a polymer composition, eg, a bioabsorbable biocompatible elastomeric polymer. The retainer 25010 may also comprise a bioabsorbable polymer such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). The retainer 25010 can include at least one therapeutic agent, such as a pharmaceutically active agent or drug.

Referring to FIG. 173 , the end effector 26012 can include an anvil 26060 and a lower jaw 26070 . In accordance with the present invention, tissue compensator 26020 can be releasably secured to anvil 26060, lower jaw 26070, and/or both anvil 26060 and lower jaw 26070. For example, a first tissue compensator 26020 can be releasably secured to the staple cartridge 26000 in the lower jaw 26070 and a second tissue compensator 26022 can be releasably secured to the anvil 26060. The first tissue compensator 26020 and the second tissue compensator 26022 can be deformable and/or elastic, similar to the at least one tissue thickness compensator described herein. For example, first tissue compensator 26020 and second tissue compensator 26022 can comprise a polymer composition, such as a bioabsorbable biocompatible elastomeric polymer. The first tissue compensator 26020 and the second tissue compensator 26022 may also comprise bioabsorbable polymers, e.g., lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). The first tissue compensator 26020 and the second tissue compensator 26022 can include at least one therapeutic agent, such as a pharmaceutically active agent or drug.

The tissue compensator 26020, 26022 can include a secure or substantially secure protective cap 26024, 26026. For example, a first protective cap 26024 can be positioned at the distal end of the first tissue compensator 26020 and a second protective cap 26026 can be positioned at the distal end of the second tissue compensator 26022 . The protective caps 26024, 26026 can prevent or limit premature deformation of the tissue compensators 26020, 26022. For example, the protective caps 26024, 26026 may protect the tissue compensators 26020, 26022 while the tissue compensators 26020, 26022 are being moved, eg, through a trocar and/or manipulated around patient tissue. Similarly, referring to FIG. 174 , end effector 12 can include a first tissue compensating member 25020 releasably secured to staple cartridge 25000 in lower jaw 25070 , and a second tissue compensating member releasably secured to anvil 25060 Part 25022. In accordance with the present invention, a protective cap 25026 can be positioned at the distal end of the second tissue compensator 25022 . The protective cap 25026 can be positioned adjacent to the deformable/resilient portion of the tissue compensator 25022. Protective cap 25026 can extend over and/or around tissue compensator 25022 such that protective cap 25026 protects the distal tip and intermediate portion of tissue compensator 25022 .

175-202, the sleeve 27010 is configured to engage, for example, an anvil 25060 of the end effector 12 of a surgical instrument. The sleeve 27010 can include a bifurcation 27040 (FIGS. 176-179), a nose 27080 (FIGS. 186-189), and a compensator 27120 (FIGS. 180-182). Cannula 27010 is capable of releasing compensator 27020 when translation of firing rod 25052 ( FIG. 196 ) approaches the distal tip of side tip effector 12 . Compensator 27020 can be deformable and/or elastic, similar to at least one tissue thickness compensator described herein. For example, compensator 27020 may comprise a polymer composition, such as a bioabsorbable biocompatible elastomeric polymer. The compensator 27020 may also include bioabsorbable polymers such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). The compensator 27020 can comprise at least one therapeutic agent, such as a pharmaceutically active agent or drug. Referring primarily to FIG. 175 , the bifurcated portion 27040 can be positioned on and/or around the outer surface 25061 of the anvil 25060 . The nose 27080 of the cannula 27010 can be positioned at and/or around the distal portion of the anvil 25060. The compensator 27020 can be positioned on and/or around the inner surface of the anvil 25060.

Still referring to FIG. 175, the bifurcated portion 27040 can include at least one prong 27042a. Optionally, as shown in FIGS. 505-508, the bifurcated portion 27040 can include a first prong 27042a and a second prong 27042b. For example, the prongs 27042a, 27042b can be symmetrical or substantially symmetrical. The first prong 27042a can be symmetrical with respect to the second prong 27042b. The first fork 27042a and/or the second fork 27042b can narrow at their distal ends. For example, each prong 27042a, 27042b can include a narrowed end 27048. Referring primarily to FIG. 178, the bifurcation 27040 may, for example, be contoured. Referring again to FIG. 175 , the profile of the bifurcated portion 27040 can match or substantially match the profile of the outer surface 25061 of the anvil 25060 , for example. Referring primarily to FIGS. 178 and 179 , the bifurcated portion 27040 can also include at least one clasp 27044a extending from the first fork 27042a. A first fastener 27044a can be positioned on a first side of the bifurcation 27040 and a second fastener 27044b can be positioned on a second side of the bifurcation 27040 . The clasps 27044a, 27044b can be positioned at or near the proximal end of the bifurcation 27040, for example. The clasps 27044a, 27044b can be positioned at or near the distal end of the bifurcation 27040, eg, along the first fork 27042a and/or the second fork 27042b. The clasps 27044a, 27044b can extend along the longer length of the bifurcation 27040 and/or the shorter length of the bifurcation 27040. For example, a plurality of fasteners 27044a, 27044b can be positioned along each longitudinal side of the bifurcation. Referring primarily to FIG. 179, the first fastener 27044a can include a first fastener extension 27046a and/or the second fastener 27044b can include a second fastener extension 27046b. For example, a first fastener extension 27046a can protrude from at least a portion of the fastener 27044a, and a second fastener extension 27046b can protrude from at least a portion of the fastener 27044b. In addition, first fastener extension 27046a and second fastener extension 27046b are each configured to engage gap 27128 ( FIG. 181 ) in compensator 27020 , as described in greater detail herein.

Referring now to FIG. 201 , a compensator 27020 for a sleeve 27010 can include a longitudinal protrusion 27024 and an edge 27026 on each longitudinal side of the compensator 27020 . The compensator 27020 can be positioned adjacent to the inner surface 25063 of the anvil 25060 . Additionally, the longitudinal protrusions 27024 can be substantially aligned with and/or positioned within the longitudinal slots 25062 in the anvil 25060 when the sleeve 27010 is positioned on the anvil 25060 . The edge 27026 of the compensator 27020 can at least partially wrap around the anvil 25060 towards the outer surface 25061 . Referring primarily to FIGS. 180-181 , a compensator 27120 for a sleeve 27110 can include a body 27122 having a longitudinal protrusion 27124 extending along at least a portion thereof. For example, longitudinal protrusion 27124 can define a longitudinal path along the midline of body 27122 . When the sleeve 27110 is positioned on the anvil 25060, the longitudinal protrusion 27124 can be received by the longitudinal slot 25062 ( FIG. 201 ) in the anvil 25060 . Referring primarily to FIG. 182, the longitudinal protrusion 27124 can comprise a lobe. For example, the cross-section of the longitudinal protrusion 27124 may form an arc and/or a partial circle. Alternatively, the longitudinal protrusions 27124 may include angled and/or stepped protrusions. Compensator 27120 may also include edges, which may be, for example, straight, curved, grooved, wavy, and/or zigzag. The edge 27126 can include a gap 27128 configured to receive the fastener extensions 27046a, 27046b when the assembled sleeve 27110 is positioned on the anvil 25060 (FIG. 179). The fastener extensions 27046a, 27046b can fit through the gap 27128 to engage the anvil 25060 such that the fastener extensions 27046a, 27046b help secure the sleeve 27110 to the anvil 25060, for example.

Referring primarily to FIGS. 183-185, a compensator 27220 for a sleeve 27210 can include a body 27222 including a longitudinal protrusion 27224 extending along at least a portion thereof. Optionally, the longitudinal protrusion 27224 can be received by the longitudinal slot 25062 ( FIG. 202 ) in the anvil 25060 when the sleeve 27210 is positioned on the anvil 25060 , similar to above. Referring primarily to FIG. 185, the longitudinal protrusions 27224 can include angled protrusions such that the cross-section of the protrusions 70224 forms a substantially rectangular shape. The compensator 27220 can also include an edge 27226, which can be, for example, straight, curved, grooved, wavy, and/or zigzag. The edge 27226 can include a gap 27228 configured to receive the fastener extensions 27046a, 27046b when the assembled sleeve 27210 is positioned on the anvil 25060 (FIG. 179). The fastener extensions 27046a, 27046b can fit through the gap 27228 and engage the anvil 25060 such that the fastener extensions 27046a, 27046b help secure the sleeve 27210 to the anvil 25060, for example. The compensator 27220 may also include a plurality of ribs 27229 traversing the body 27222 of the compensator 27220 . The ribs 27229 can support the body 27222 of the compensator 27220 when the sleeve 27210 is positioned on the anvil 25060 and/or when the compensator 27220 contacts tissue.

Referring to FIGS. 386-390 , the nose 27080 of the sleeve 27010 can include alignment ridges 27082 that can substantially align with the longitudinal slots 25062 ( FIG. 201 ) in the anvil 25060 . The nose 27082 can at least partially surround a distal portion of the bifurcation 27040 of the sleeve 27010 when the alignment ridge 27082 is aligned with the longitudinal slot 25062 and when the sleeve 27010 is positioned on the anvil 25060 . For example, when the sleeve 27010 is positioned over the anvil 25060, the narrow end 27048 of each prong 27042a, 27042b can be positioned within the nose 27080. As described in greater detail herein, when the bifurcated portion 27042 is engaged with the nose portion 27080, the nose portion 27080 can flex the prongs 27042a, 27042b closer to each other and/or downwardly. Furthermore, as shown in FIG. 190 , the clasps 27044 a , 27044 b on the bifurcation 27040 can engage, for example, the edge 27026 of the compensator 27020 when the narrow end 27048 of the bifurcation 27040 is positioned within the nose 27080 . Due to this engagement, compensator 27010 may be secured to anvil 25060 .

191-195, when the nose 27080 is engaged with the bifurcated portion 27040 of the sleeve 27010, the compensator 27020 can be secured to the anvil 25060. The nose 27080 can remain engaged with the bifurcation 27040 as the firing rod 25050 translates along a portion of the longitudinal slot 25062 in the anvil 25060 . Referring now to FIGS. 195-200 , when the cutting element 25052 on the firing rod 25050 and/or any other suitable portion of the firing rod 25050 (e.g., retaining flange 25054 ) approaches the distal end of the anvil 25060 , the firing rod 25050 can cause The nose 27080 is separated from the bifurcation 27040. The firing rod 25050 can, for example, contact the nose 27080 and push the nose 27080 away from the anvil 25060 such that the nose 27080 is separated from the bifurcation 27040 of the cannula 27010. Referring now to FIG. 202 , when the nose 27080 is separated from the bifurcation 27040 , the first prong 27042a and the second prong 27042b can flex away from the anvil 25060 . For example, when the bifurcated portion 27070 is engaged with the nose portion 27080, the prongs 27042a, 27042b can flex closer to each other and/or downwardly toward the anvil 25060 and can be held in such a position by the nose portion 27080. The prongs 27042a, 27042b may be held under spring load by the nose 27080 such that the prongs 27042a, 27042b attempt to spring back to the neutral configuration once the nose 27080 is separated from the prongs 27042a, 27042b. Alternatively, the prongs 27042a, 27042b may be sufficiently deformable such that the prongs 27042a, 27042b may deform or expand outwardly through the firing rod 25050 once separated therefrom at the nose 27080. As the forks 27042a, 27042b move away from the anvil 25060, the clasps 27044a, 27044b along the longitudinal sides of each fork 27042a, 27042b can disengage the compensator 27020, which can allow the compensator 27020 to be released from the anvil 25060.

203-209, the end effector 12 of a surgical instrument can receive an end effector insert 28010, for example. The end effector insert 28010 can include a compensator body 28012 and at least one clamp 28014a, 28014b. The end effector insert 28010 can include, for example, a proximal clamp 28014b at a proximal end of the compensator body 28012 , and a distal clamp 28014a at a distal end of the compensator body 28012 . Referring primarily to FIG. 206 , the distal clamp 28014a can be secured to the anvil 25060 of the end effector 12 at or near the distal end of the anvil 25060 . For example, the distal clamp 28014a can be substantially aligned with and/or can be partially positioned within the longitudinal slot 25062 of the anvil 25060 . Referring primarily to FIG. 207, the proximal clamp 28014b can be secured to the staple cartridge 25000 in the lower jaw 25070 of the end effector 12 (FIG. 208). Proximal clamp 28014b can be secured to staple cartridge 25000 at or near its proximal end. For example, proximal end clamp 28014b can be substantially aligned with and/or can be positioned within longitudinal slot 25004 in staple cartridge 25000 .

Referring now to FIGS. 208 and 209, the end effector insert 28010 can be inserted into the end effector 12 of the surgical instrument. Optionally, at least a portion of the end effector insert 28010 (eg, the compensator body 28012, the distal clip 28014a, and/or the proximal clip 28014b) can be deformable and/or elastic, for example. When the end effector insert 28010 is inserted into the end effector 12, the distal and/or proximal clamps 28014a, 28014b may bend or flex. When the clips 28014a, 28014b, for example, flex, the clips 28014a, 28014b, for example, can attempt to return to their original, undeformed configuration and can generate a corresponding resilient or restoring force. Optionally, the end effector insert 28010 can apply a spring load to the end effector 12 when the end effector insert 28010 is positioned within the end effector 12 . End effector insert 28010 can be solid or substantially solid such that an operator can grasp insert 28010 while end effector insert 28010 and staple cartridge 25000 are being inserted into end effector 12 .

End effector insert 28010 may be removed from end effector 12 prior to cutting and/or fastening operations of end effector 12 . Alternatively, end effector insert 28010 may remain positioned in end effector 12 during cutting and/or firing operations. For example, the end effector insert 28010 can be transected by the cutting element 25052 as the staples are fired from the staple cavities 25002 ( FIG. 207 ) in the staple cartridge 25000 thereof. End effector insert 28010 can comprise a tissue thickness compensating material similar to at least one of the tissue thickness compensators described herein. For example, end effector insert 28010 can comprise a polymer composition, such as a bioabsorbable biocompatible elastomeric polymer. The end effector insert 28010 may also comprise bioabsorbable polymers such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). End effector insert 28010 can include at least one therapeutic agent, such as a pharmaceutically active agent or drug.

210-215, a tissue thickness compensator 29020 can be positioned in the end effector 12 of the surgical instrument. Tissue thickness compensator 29020 can be substantially similar to at least one of the tissue thickness compensators described herein. For example, the tissue thickness compensator 29020 can be sufficiently deformable and elastic such that deformation of the tissue thickness compensator 29020 produces a resilient or restoring force. Referring primarily to FIG. 211 , an electrostatic charge can attract the tissue thickness compensator 29020 to the anvil 25060 of the end effector 12 such that the electrostatic charge secures the tissue thickness compensator 29020 to the anvil 25060 . Static charges can be neutralized such that the anvil 25060 releases the tissue thickness compensator 29020. Additionally or alternatively, referring now to FIG. 212 , tissue thickness compensator 29020 may be secured to anvil 25060 by at least one suction element 29022 . For example, a plurality of microsuction elements 29022 on the surface of tissue thickness compensator 29020 can releasably secure tissue thickness compensator 29020 to anvil 25060 . Additionally or alternatively, referring to FIG. 213 , hook-and-loop fasteners 29024 can secure tissue thickness compensator 29020 to anvil 25060 . For example, the surface of the tissue thickness compensator 29020 can include a plurality of hook fasteners 29024a, and the surface of the anvil 25060 can include a plurality of loop fasteners 29024b, for example. Hook fastener 29024a can engage loop fastener 29024b such that tissue thickness compensator 29020 is releasably secured to anvil 25060 .

Additionally or alternatively, referring now to FIG. 214 , tissue thickness compensator 29020 may be secured to anvil 25060 by strap 29026 . Band 29026 may comprise an elastomeric polymer and/or may be tied or knotted around anvil 25060. When the band 29026 is removed from the anvil 25060, the tissue thickness compensator 29020 can be released from the anvil 25060. To facilitate removal of the strap 29026, it may be stretched and/or cut, for example. A plurality of straps 29026 can secure tissue thickness compensator 29020 to anvil 25060 in accordance with the present invention. Alternatively or in addition, referring now to FIG. 215 , the tissue thickness compensator 29020 can be secured to the anvil 25060 by a socket 29028 positioned at the distal end of the tissue thickness compensator 29020 . Socket 29028 is configured to receive, for example, the distal tip of anvil 25060 therein. The alignment edge 29029 on the tissue thickness compensator 29020 can be aligned with and/or can be positioned within the longitudinal slot 25062 in the anvil 25060 . For example, alignment edge 29029 can slide within longitudinal slot 25062 when tissue thickness compensator 29020 is positioned on and/or removed from anvil 25060 .

216-218, the tissue thickness compensator 30020 can be positioned on the anvil 25060 of the end effector 12 of the surgical instrument. The tissue thickness compensator 30020 can include a body 30022 and a pocket 30024 . For example, compensator material 30026 may be retained between body 30022 and dimple 30024 . The compensator material 30026 may comprise bioabsorbable polymers such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). Additionally or alternatively, the compensator material 30026 may include at least one therapeutic agent, such as a pharmaceutically active agent or drug. Tissue thickness compensator 30020 can be deformable and/or elastic, similar to at least one tissue thickness compensator described herein. For example, a tissue thickness compensator can comprise 30020 a polymer composition, such as a bioabsorbable biocompatible elastomeric polymer. The tissue thickness compensator 30020 may also include bioabsorbable polymers such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC).

Referring primarily to FIG. 217 , the body 30022 of the tissue thickness compensator 30020 can include an alignment element 30028 that can be received within the longitudinal slot 25062 of the anvil 25060 when the tissue thickness compensator 30020 is secured to the anvil 25060 . Body 30022 can include a stepped thickness such that the geometry of body 30022 substantially corresponds to the geometry of anvil 25060 . Additionally, the body 30022 can include a longitudinal flange 30029 . For example, a longitudinal flange 30029 can extend along each longitudinal side of the body 30022 of the tissue thickness compensator 30020, for example. Longitudinal flange 30029 can at least partially surround anvil 25060 to secure tissue thickness compensator 30020 to anvil 25060 . Also, for example, the longitudinal flange 30029 can be sufficiently elastic such that the longitudinal flange 30029 can flex to conform to and/or engage the anvil 25060 . The longitudinal flange 30029 can apply a clamping force to the anvil 25060 when the flange 30029 engages the anvil 25060 . Dimples 30024 may include dimples 30025 . When the tissue thickness compensator 30020 is secured to the anvil 25060, the indentation 30025 can be substantially aligned with the longitudinal slot 25062 in the anvil 25060, for example. The tissue thickness compensator 30020 can be thinner at the indentation 30025 such that the translating cutting element 25052 (FIG. 207) severes the tissue thickness compensator 30020 at the thinner location.

Referring now to FIGS. 219 and 220 , a tissue thickness compensator 30120 can include a body 30122 configured to retain a compensating material 30026 therein. Tissue thickness compensator 30120 can include alignment elements 30128 , indents 30125 , and/or longitudinal flanges 30129 . The tissue thickness compensator 30120 can also include a latch 30124 movable between an open position and a closed position. When the latch 30124 is in the closed position, as shown in FIG. 219, the compensating material 30026 can be enclosed within the body 30122 of the tissue thickness compensator 30120, and when the latch 30124 is in the open position, as shown in FIG. Material 30026 can escape from body 30122 . Similar to at least one of the tissue thickness compensators described herein, the tissue thickness compensator 30120 can be deformable and/or elastic. For example, tissue thickness compensator 30120 can comprise a polymer composition, such as a bioabsorbable biocompatible elastomeric polymer. The tissue thickness compensator 30120 may also include bioabsorbable polymers, eg, lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). Due to the elasticity of the tissue thickness compensator 30120, at least a portion of the body 30122 can flex to move the latch 30124 between an open position and a closed position. The body 30122 of the tissue thickness compensator 30120 can remain attached to the anvil when the anvil is removed from the surgical site. For example, the body 30122 can be torn away from any staples in which the body 30122 may have been captured.

Referring to FIG. 221 , a tissue thickness compensator 30220 can include a body 30222 and a dimple 30224 . For example, compensator material 30026 may be retained between body 30222 and dimple 30224 . The tissue thickness compensator 30220 can include alignment elements, indentations, and/or longitudinal flanges 30229 . Additionally, at least one longitudinal flange 30229 can include a groove or slot 30228 configured to receive a tab 30225 extending from a pocket 30224 of the tissue thickness compensator 30220 . In this case, the engagement of the groove 30228 with the tab 30225 can connect the body 30222 and the pocket 30224 . Additionally, in such instances, the connection of the grooves 30028 to the tabs 30025 can encapsulate and/or retain the compensating material 30026 within the tissue thickness compensator 30220 . Referring now to FIG. 222a, the pocket 30324 of the tissue thickness compensator 30320 can include an anchor 30325 extending therefrom. Additionally, the tissue thickness compensator 30320 can include a body 30322 having an opening 30328 . Anchors 30325 can extend from recesses 30324 to engage openings 30328 in body 30322 . In such a configuration, the dimples 30324 and the body 30222 can encapsulate the compensating material 30026 therebetween. The tissue thickness compensator 30320 can also include one or more flanges 30229 that can be mounted to the anvil to retain the body 30322 to the anvil.

Referring now to FIG. 223 , a tissue thickness compensator 30420 can include a body 30422 and a pocket 30424 . A compensating material 30026 can be retained between the body 30422 and the pocket 30424 of the tissue thickness compensator 30420 . The body 30422 can include an aperture 30428 and the pocket 30424 can include an anchor 30425 . For example, the anchor 30425 can extend from the recess 30424 and through the aperture 30428 of the body 30422 . For example, the anchors 30425 can engage the anvil 25060 when the tissue thickness compensator 30420 is secured to the anvil 25060 . Anchor 30525 may be sufficiently deformable and elastic such that anchor 30425 flexes when engaging anvil 25060 . Additionally, the deflected anchors 30425 can apply a clamping force to the anvil 25060 to secure or assist in securing the tissue thickness compensator 30420 to the anvil 25060 . Alternatively, the anchor may not extend completely through the aperture in the compensator body. Referring to FIG. 224 , the anchors 30525 on the pockets 30524 of the tissue thickness compensator 30520 can engage the apertures 30528 in the body 30522 of the tissue thickness compensator 30520 . Anchor 30525 can engage aperture 30528 to secure pocket 30524 to body 30522 . For example, the aperture 30528 can include a necked-in portion that extends into the socket. Anchor 30525 can include a securing edge that can pass through the constriction and engage the socket to secure anchor 20525 within aperture 30528 . For example, tissue thickness compensator 30520 can also include alignment elements, indentations, and/or longitudinal flanges 30529 .

225-227, a tissue thickness compensator 31020 can be configured to engage an anvil 31060 of an end effector 31012 of a surgical instrument. The tissue thickness compensator 31020 can include an outer membrane 31022, an inner membrane 31024, and a compensating material 31026 positioned therebetween. Tissue thickness compensator 31020 can be deformable and/or elastic, similar to at least one of the tissue thickness compensators described herein. For example, compensating material 31026 can comprise a polymer composition, such as a bioabsorbable biocompatible elastomeric polymer. The tissue thickness compensator 31020 may also include bioabsorbable polymers such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). Tissue thickness compensator 31020 can include at least one therapeutic agent, such as a pharmaceutically active agent or drug. The compensation material 31206 of the tissue thickness compensator 31020 can include a therapeutic agent.

For example, the inner membrane 31024 can be positioned adjacent to the staple forming pockets 31066 in the anvil 31060 . Referring primarily to FIG. 225 , the inner membrane 31024 can include a stepped geometry such that the geometry of the inner membrane 31024 substantially corresponds to the geometry of the anvil 31060 . The inner membrane 31024 can also include alignment ridges 31028 that can be substantially aligned with and/or parallel to the longitudinal slot 31062 in the anvil 31060 , for example. As described in greater detail herein, the inner membrane 31024 can include inner flanges 31025 extending from each longitudinal side of the inner membrane 31024 and terminating in clasps 31027 . The outer membrane 31022 can include, for example, a main body 31021 and at least one outer flange 31023 . Optionally, for example, an outer flange 31023 can extend from each longitudinal side of the main body 31021 . Outer flange 31023 can be secured to inner flange 31025 such that compensating material 31026 remains between outer membrane 31022 and inner membrane 31024 .

Referring primarily to FIG. 227 , the anvil 31060 can include an outer surface 31061 and at least one groove 31064 along at least a portion of the outer surface 31061 . According to the present invention, the fastener 31027 on the inner flange 31025 of the inner membrane 31024a can be positioned within the groove 31064. Referring to FIG. 226 , for example, a tissue thickness compensator 31020 can be slid about an anvil 31060 . The groove 31064 on the anvil 31060 can extend to the distal end of the anvil 31060. In such cases, the clasp 31027 of the tissue thickness compensator 31020 can slide within the groove 31064 and along the length of the tissue thickness compensator 31020 .

Referring now to FIGS. 228 and 229 , a tissue thickness compensator 31120 can include a compensating material 31026 and at least one connector 31124 . Each connector 31124 can extend around the compensating material 31026 and can terminate in a clasp 31127 at its opposite end. Fasteners 31127 can be positioned within grooves 31064 of anvil 31060 to secure tissue thickness compensator 31120 to anvil 31060 . The groove 31164 on the anvil 31060 can extend to the distal end of the anvil 31060. In such cases, the clasp 31127 of the connector 31124 can be slid into the groove 31064 . Alternatively, connectors 31224 may be elastic such that they can flex and snap around anvil 31060. The connector 31224 can hold the compensating material 31026 in place until the compensating material 31026 is separated from the anvil 31060 during use. In some cases, connector 31224 can remain attached to anvil 31060 and can be removed from the surgical site along with the anvil. In certain other cases, connector 31224 can be detached from anvil 31060 and can be implanted with compensating material 31026 .

Referring to FIGS. 230-236 , the tissue thickness compensator 32020 can include a body portion 32022 , at least one longitudinal flange 32024 , and at least one dimple 32026 . Tissue thickness compensator 31020 can be deformable and/or elastic, similar to at least one of the tissue thickness compensators described herein. For example, compensating material 31026 can comprise a polymer composition, such as a bioabsorbable biocompatible elastomeric polymer. The tissue thickness compensator 31020 may also include bioabsorbable polymers such as lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and/or oxidized regenerated cellulose (ORC). A longitudinal flange 32024 can extend along each longitudinal side of the body portion 32022 . Referring primarily to FIG. 233 , the longitudinal flange 32024 of the tissue thickness compensator 32020 is configured to engage the anvil 25060 . For example, tissue thickness compensator 32020 can be slid onto anvil 25060 and longitudinal flange 32024 and can at least partially surround a portion of anvil 25060 . In such cases, flange 32024 can secure tissue thickness compensator 32020 to anvil 25060, for example. Optionally, the main body portion 32022 of the tissue thickness compensator 32020 can overlap the staple forming pockets 25066 on the surface of the anvil 25060 when the tissue thickness compensator 32020 is secured to the anvil.

Further to the above, the plurality of dimples 32026 may traverse the body portion 32022 laterally. Referring primarily to FIG. 234, the plurality of wells 32026 can include at least one therapeutic agent, such as a pharmaceutically active agent or drug. According to the present invention, the first plurality of wells 32026a can include a first therapeutic agent or a combination thereof, and the second plurality of wells 32026b can include a second therapeutic agent or a combination thereof. The first dimples 32026a and the second dimples 32026b can be alternately positioned, for example, along the body portion 32022 . Furthermore, when the first therapeutic agent is released from the first well 32026a and the second therapeutic agent is released from the second well 32026b, the first therapeutic agent and the second therapeutic agent can react with each other. Referring to FIG. 236 , for example, when the cutting element 25052 on the firing rod 25050 is translated along the longitudinal slot 25062 in the anvil 25060 , the pockets 32026 can release the therapeutic agent held therein.

Referring now to FIG. 237 , an end effector of a surgical stapling instrument can include an anvil 32560 and a staple cartridge 32500 having a tissue thickness compensator 32520 . Similar to the above, the staple cartridge 32500 can include a plurality of staples 32530 at least partially received therein that can be ejected from the staple cartridge to capture the tissue thickness compensator 32520 therein. Also similar to above, staples 32530 can penetrate tissue thickness compensator 32520 and contact staple forming pockets 32562 defined in anvil 32560 . Referring now to FIG. 239 , the anvil 32560 can also include a layer 32570 attached thereto that can be configured to retain the tissue thickness compensator 32580 to the anvil 32560 . For example, layer 32570 can include a charge layer capable of retaining and/or generating an electrostatic charge and attracting tissue thickness compensator 32580 . More specifically, van der Waals molecular forces (whether actively or passively actuated), for example, can hold tissue thickness compensator 32580 to layer 32570 . Charged layer 32570 can be in electrical communication with a handle of a surgical stapling instrument, which can include a control that enables selective coupling of charged layer 32570 with a power source and thus allows selective generation of static charge. For example, charging layer 32570 may include conductive electrodes, eg, embedded within a polymer. In any event, the electrostatic layer 32570 can attract oppositely charged particles in the tissue thickness compensator 32580 and retain the tissue thickness compensator 32580 to the anvil. Referring now to FIG. 238, the charging layer 32570 may comprise a mesh or grid of conductors 32571 in electrical communication with each other. For example, the conductors can be positioned and arranged such that they surround staple forming pockets 32562 defined in the anvil 32560 . Under such circumstances, the staples 32530 can be ejected from the staple cartridge 32500 and then can be deformed by the anvil 32560 without the conductor 32571 being captured therein. In various instances, the charging layer 32570 can be disconnected from the power source after the staples 32530 have been engaged with the tissue thickness compensator 32580 so that the static charge in the layer 32570 can be dissipated. In certain other cases, the charging layer 32570 may be disconnected from the power source before the staples 32530 are being fired. In any event, when the electrostatic charge dissipates, the anvil 32560 can be reopened and the layer 32570 can be moved away from the tissue thickness compensator 32580. The static charge may need to be completely dissipated before the layer 32570 can be detached from the tissue thickness compensator 32580, while alternatively, the layer 32570 can be detached from the tissue thickness compensator 32580 before the static charge in the layer 32570 has been completely dissipated. As a result of the foregoing, the tissue thickness compensator 32580 can be attached to the anvil 32560 without the use of chemical adhesives.

Further to the above, layer 32570 may also provide feedback capabilities for the handle of the surgical stapling instrument. For example, layer 32570 may be pressure sensitive and capable of detecting the clamping pressure being applied thereto by, for example, anvil 32560 .

Further to the above, the tissue thickness compensator may be constructed of a biocompatible material. Biocompatible materials (e.g., foams) can include tackifiers, surfactants, fillers, crosslinkers, pigments, dyes, antioxidants, and other stabilizers, and/or combinations thereof, to provide the material with the desired required features. Biocompatible foams may include surfactants. Surfactants can be applied to the surface of the material and/or can be dispersed within the material. Without being bound by any particular theory, a surfactant applied to a biocompatible material can lower the surface tension of fluids that contact the material. For example, surfactants can reduce the surface tension of water contacting a material to facilitate water penetration into the material. Water can act as a catalyst. Surfactants can increase the hydrophilicity of materials.

Surfactants may include anionic surfactants, cationic surfactants, and/or nonionic surfactants. Examples of surfactants include, but are not limited to, polyacrylic acid, methalose, methylcellulose, ethylcellulose, propylcellulose, hydroxyethylcellulose, carboxymethylcellulose, polyoxyethylene cetyl ether, polyoxyethylene Ethylene lauryl ether, polyoxyethylene octyl ether, polyoxyethylene octyl phenyl ether, polyoxyethylene oleyl ether, polyoxyethylene sorbitan monolaurate, polyoxyethylene stearyl ether, polyoxyethylene Nonylphenyl ethers, dialkylphenoxypoly(ethyleneoxy)ethanols, poloxamers, and combinations thereof. Surfactants may include copolymers of polyethylene glycol and polypropylene glycol. Surfactants may include phospholipid surfactants. Phospholipid surfactants can provide antimicrobial stabilizing properties and/or can disperse other materials in the biocompatible material.

The tissue thickness compensator can include at least one drug. The tissue thickness compensator may comprise one or more of the natural materials, non-synthetic materials, and/or synthetic materials described herein. The tissue thickness compensator may comprise a biocompatible foam comprising gelatin, collagen, hyaluronic acid, oxidized regenerated cellulose, polyglycolic acid, polycaprolactone, polylactic acid, polydioxane Hexanone, polyhydroxyalkanoate, polycapron, and combinations thereof. The tissue thickness compensator can include a membrane containing at least one drug. The tissue thickness compensator can include a biodegradable film containing at least one drug. Medications may include liquids, gels, and/or powders. Drugs may include anticancer drugs, eg, cisplatin, mitomycin, and/or doxorubicin.

The tissue thickness compensator may comprise a biodegradable material to provide controlled elution or release of the at least one drug as the biodegradable material degrades. When the biodegradable material contacts an activator (eg, an activator fluid), the biodegradable material can degrade, disintegrate, or lose structural integrity. The activator fluid may include, for example, saline solution or any other electrolyte solution. The biodegradable material can be contacted with the activator fluid by conventional techniques including, but not limited to, spraying, dipping, and/or brushing. In use, for example, a surgeon may dip an end effector and/or a staple cartridge comprising a tissue thickness compensator containing at least one drug into an activator fluid (including a saline solution, e.g., sodium chloride, calcium chloride, and/or potassium chloride). The tissue thickness compensator can release the drug when the tissue thickness compensator degrades. Elution or release of drug from the tissue thickness compensator can be characterized by a fast initial elution or release rate and a slower sustained elution or release rate.

According to the invention, the tissue thickness compensator can for example consist of a biocompatible material which can include an oxidizing agent. The oxidizing agent may be an organic peroxide and/or an inorganic peroxide. Examples of oxidizing agents may include, but are not limited to, hydrogen peroxide, carbamide peroxide, calcium peroxide, and magnesium peroxide, and sodium percarbonate. Oxidizing agents may include peroxyl and hypochlorous acid-based oxidizing agents, eg, hydrogen peroxide, hypochlorous acid, hypochlorites, hypocodites, and percarbonates. Oxidizing agents may include alkali metal chlorites, hypochlorites, and perborates, for example, sodium chloride, sodium hypochlorite, and sodium perborate. The oxidizing agent may include vanadate. Oxidizing agents may include ascorbic acid. The oxidizing agent may include active oxygen generators. According to the present invention, the tissue scaffold may comprise an oxidizing agent-containing biocompatible material.

Biocompatible materials may include liquids, gels, and/or powders. The oxidizing agent may include, for example, microparticles and/or nanoparticles. For example, the oxidizing agent can be ground into microparticles and/or nanoparticles. The oxidizing agent can be incorporated into the biocompatible material by suspending the oxidizing agent in the polymer solution. Oxidizing agents may be incorporated into the biocompatible material during the lyophilization process. After lyophilization, the oxidizing agent can attach to the cell walls of the biocompatible material to interact with the tissue upon contact. The oxidizing agent may not be chemically bonded to the biocompatible material. Dry percarbonate powder can be embedded in biocompatible foam to provide long-lasting biological effects through the slow release of oxygen. Dry percarbonate powder can be embedded in polymer fibers with a non-woven structure to provide long-lasting biological effects through the slow release of oxygen. Biocompatible materials can include oxidizing agents and drugs, eg, doxycycline and ascorbic acid.

Biocompatible materials may include fast release oxidants and/or slower sustained release oxidants. The elution or release of the oxidizing agent from the biocompatible material can be characterized by a fast initial elution or release rate and a slower sustained elution or release rate. When the oxidizing agent contacts a bodily fluid (eg, water), the oxidizing agent can generate oxygen. Examples of bodily fluids may include, but are not limited to, blood, plasma, peritoneal fluid, cerebrospinal fluid, urine, lymph, synovial fluid, vitreous humor, saliva, gastrointestinal luminal contents, and/or bile. Without being bound by any particular theory, oxidizing agents may reduce cell death, enhance tissue viability, and/or maintain tissue-tissue mechanical strength that may be damaged during cutting and/or stapling.

The biocompatible material may comprise at least one microparticle and/or nanoparticle. Biocompatible materials may include one or more of natural materials, non-synthetic materials, and synthetic materials described herein. The biocompatible material may comprise particles having an average diameter of about 10 nm to about 100 nm and/or about 10 μm to about 100 μm (eg, 45-50 nm and/or 45-50 μm). The biocompatible material may include a biocompatible foam including at least one microparticle and/or nanoparticle embedded therein. The microparticles and/or nanoparticles may not be chemically bonded to the biocompatible material. Microparticles and/or nanoparticles can provide controlled release of drugs. Microparticles and/or nanoparticles may include at least one drug. Microparticles and/or nanoparticles can include, for example, hemostatic agents, antimicrobial agents, and/or oxidizing agents. The tissue thickness compensator may comprise a biocompatible foam comprising a hemostatic agent comprising oxidized regenerated cellulose, an antimicrobial agent comprising doxycycline and/or gentamicin, and/or a percarbant of oxidants. The microparticles and/or nanoparticles can provide controlled release of the drug, eg, for up to three days.

Microparticles and/or nanoparticles can be embedded into biocompatible materials during the manufacturing process. For example, a biocompatible polymer (eg, PGA/PCL) can be contacted with a solvent (eg, dioxane) to form a mixture. Biocompatible polymers can be ground to form particles. Dry particles, with or without ORC particles, can be contacted with the mixture to form a suspension. The suspension can be lyophilized to form a biocompatible foam comprising PGA/PCL with dried particles and/or ORC particles embedded therein.

The tissue thickness compensators or layers disclosed herein can be composed of absorbable polymers, for example. The tissue thickness compensator may consist of, for example, foam, film, fiber woven, fiber nonwoven PGA, PGA/PCL (poly(glycolic acid-co-caprolactone)), PLA/PCL (poly(lactic acid-co-caprolactone)), PLA/PCL (poly(lactic acid-co- -polycaprolactone)), PLLA/PCL, PGA/TMC (poly(glycolic acid-co-trimethylene carbonate)), PDS, PEPBO, or other resorbable polyurethane, polyester, polycarbonate, poly Orthoesters, polyanhydrides, polyesteramides, and/or polyoxyesters. According to the invention, the tissue thickness compensator consists of, for example, PGA/PLA (poly(glycolic acid-co-lactic acid)) and/or PDS/PLA (poly(p-dioxanone-co-lactic acid)). According to the invention, the tissue thickness compensator can consist, for example, of an organic material. The tissue thickness compensator can be composed of, for example, carboxymethyl cellulose, sodium alginate, cross-linked hyaluronic acid, and/or oxidized regenerated cellulose. According to the present invention, the tissue thickness compensator may comprise, for example, a durometer in the range of 3-7 Shore A durometer (30-50 Shore OO durometer), with a maximum stiffness of 15 Shore A durometer (65 Shore OO durometer). The tissue thickness compensator can be 40% compressed at a 3 lbf load, 60% compressed at a 6 lbf load, and/or 80% compressed at a 20 lbf load. One or more gases (eg, air, nitrogen, carbon dioxide, and/or oxygen) may be bubbled into the tissue thickness compensator and/or may be contained within the tissue thickness compensator. The tissue thickness compensator may include particles therein which may comprise from about 50% to greater than 75% of the hardness of the material comprising the tissue thickness compensator.

According to the present invention, tissue thickness compensators may include, for example, hyaluronic acid, nutrients, fibrin, thrombin, platelet-rich plasma, sulfasalazine ( – 5ASA + sulfapyridine azo bond)) – prodrug – colonic bacteria (azoreductase), aminosalicylic acid (5ASA with different prodrug structure for delayed release), (5ASA+Acrylic-S coated –pH>7 (coating dissolved)), (5ASA+ ethylcellulose coated – time/pH dependent sustained release), (5ASA+acrylic-L-coated –pH>6), olsalazine (5ASA+5ASA-colic bacteria (azoreductase)), balsalazide (5ASA+4aminobenzoyl-B-alanine ) - colonic bacteria (azoreductase)), aminosalicylic acid granular, Lialda (sustained release and SR formulations of aminosalicylic acid), HMPL-004 (can inhibit TNF-α, interleukin-1β, and nuclear-kB activation herbal mixture), CCX282-B (an oral chemokine receptor antagonist that interferes with T lymphocyte trafficking into the intestinal mucosa), rifaximin (a nonabsorbable broad-spectrum antibiotic), infliximab, murinechymieric (Monoclonal antibodies targeting TNF-α approved for reducing signs/symptoms, maintaining clinical remission in adult/pediatric patients taking moderate/severe phenobarbital, and for inadequate Crohn's disease responding to conventional therapy (ostomy), adalimumab, human IgG1 (anti-TNF-alpha monoclonal antibody - approved for reducing signs/symptoms of Crohn's disease and may be used to reduce and maintain patients with inadequate response to routine Treatment of moderately/severely active Crohn's disease or clinical remission in adult patients intolerant to infliximab), Certolizumab pegoll, humanized anti-TNF FAB' (monoclonal antibody fragment linked to polyethylene glycol- Approved to reduce signs/symptoms of Crohn's disease and may be used to reduce and maintain response in moderately/severely ill adult patients with inadequate response to conventional therapy), natalizumab, first non-TNF-α Inhibitor (biological compound approved for Crohn's disease), humanized monoclonal IgG4 antibody (targets alpha-4 integrin - FDA-approved for inducing and maintaining moderate/severe clinical response and remission in patients with disease who do not respond adequately or are unable to tolerate conventional Crohn therapy and TNF-α inhibitors), concomitant immunomodulators that may be administered with infliximab), azathioprine-6 - Mercaptopurine (purine synthesis inhibitor-prodrug), methotrexate (binds dihydrofolate reductase (DHFR) enzyme, which is involved in tetrahydrofolate synthesis, inhibits all purine synthesis), allopurinol and thio Azathioprine therapy, PPIs, H2 for acid suppression to protect the healing line, C-Diff–Flagyl, vancomycin (manipulation of fecal translocation; beneficial strains; repopulation of normal luminal flora), and/or Faximin (treatment of bacterial overgrowth (notably hepatic encephalopathy); not absorbed from the gastrointestinal tract and does not act on intraluminal bacteria).

As described herein, a tissue thickness compensator can, for example, compensate for changes in the thickness of tissue captured within staples fired from a staple cartridge and/or contained within the staple line. In other words, some staples within the staple line can capture thicker portions of tissue while other staples within the staple line can capture thinner portions of tissue. In such cases, the tissue thickness compensator can assume different heights or thicknesses within the staple and can apply a compressive force to tissue captured within the staple regardless of whether the captured tissue is thick or thin. According to the present invention, the tissue thickness compensator compensates for changes in tissue stiffness. For example, some staples within the staple line can capture highly compressed portions of tissue, while other staples within the staple line can capture less compressed portions of tissue. In such cases, the tissue thickness compensator can, for example, assume a smaller height within the staples that have captured tissue of lower compressibility or higher stiffness, and correspondingly, have captured tissue of higher compressibility or stiffness. Tissues with low stiffness exhibit a greater height inside the nail. In any event, a tissue thickness compensator may be referred to as, for example, a "tissue compensator" and/or a "compensator", eg, whether or not it compensates for tissue thickness variations and/or tissue stiffness variations.

The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning may include any combination of disassembly of the device, followed by cleaning or replacement of parts, and subsequent assembly. In particular, the device may be disassembled and any number of specific parts or portions of the device may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular parts, the device may be reassembled for subsequent use at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of these techniques, as well as the resulting prosthetic devices, are within the scope of the present invention.

Preferably, the invention described herein will be treated prior to surgery. First, obtain a new or used unit and, if necessary, have the unit cleaned. The device is then sterilized. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device are then placed in a field of radiation capable of penetrating the container, such as gamma radiation, x-rays or high energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device is then stored in the sterile container. The sealed container keeps the instrument sterile until the container is opened in the medical facility.

Any patent, patent publication, or other published material incorporated herein by reference, in whole or in part, is only to the extent that the incorporated material does not conflict with an existing definition, statement, or other disclosed material set forth herein. into this article. Accordingly, to the extent necessary, the disclosure as expressly set forth herein supersedes any conflicting material incorporated herein by reference. To the extent that any material, or portion thereof, is said to be incorporated herein by reference but conflicts with existing definitions, statements, or other disclosed material stated herein, nothing arises solely between the incorporated material and the existing disclosed material. incorporated herein to the extent of conflict.

While this invention has been described as an exemplary design, further modifications can be made to the present invention within the spirit and scope of this disclosure. This patent application is therefore intended to cover any variations, uses or adaptations of the general principles of the invention. Furthermore, this patent application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

Claims (6)

1. a kind of compensating part, it can be attached to the anvil block of fastening instrument, wherein the anvil block include can be with the fastener The fastener cartridge jaw of tool profiled surface positioned opposite, and wherein described compensating part includes：

Pipe, the pipe is made up of two or more as the housing that a part for expressing technique is formed together, wherein described Pipe includes hole, side wall, first end and the second end in the restriction hole, wherein the side wall entirely close to the anvil block into Arrange shape surface and the fastener cartridge jaw；

Strands line, the strands line are configured to be pulled through the hole so that the strands line can be in the benefit It is cut during repaying the manufacture of part with together with the pipe；With

Attachment part, the attachment part can be attached to the anvil block.

2. compensating part according to claim 1, wherein the strands line is made up of oxidized regenerated cellulose.

3. compensating part according to claim 1, wherein the pipe is made up of polymeric material.

4. compensating part according to claim 1, it is configured to engage the anvil block wherein the attachment portion includes The first side the first flank and be configured to engage the anvil block the second side the second flank.

5. a kind of compensating part, it can be attached to the anvil block of fastening instrument, wherein the anvil block includes profiled surface, and wherein The compensating part includes：

Pipe, the pipe is made up of two or more as the housing that a part for expressing technique is formed together, wherein described Pipe includes hole, first end and second end, wherein the first end and the second end have been sealed and closed；

Strands line, the strands line are configured to be pulled through the hole so that the strands line can be in the benefit It is cut during repaying the manufacture of part with together with the pipe；With

Attachment part, the attachment part are configured to be attached to the anvil block.

6. a kind of compensating part, it can be attached to the anvil block of fastening instrument, wherein the anvil block includes profiled surface, and wherein The compensating part includes：

Pipe, the pipe is made up of two or more as the housing that a part for expressing technique is formed together, wherein described Pipe includes hole, first end and second end；

Strands line, the strands line are configured to be pulled through the hole so that the strands line can be in the benefit It is cut during repaying the manufacture of part with together with the pipe；With

Attachment part, the attachment part are configured to be attached to the anvil block,

Wherein described pipe includes flexure joints.