HK1237594B - Apparatus and method for at least one of perfusion, storage, assessment and transport of an organ or tissue - Google Patents

Description

Device and method for at least one of perfusion, storage, evaluation, and transport of an organ or tissue

This application is a divisional application of the invention patent application with an international application date of July 8, 2013, international application number PCT/US2013/049584, application number 201380046784.5 entering the Chinese national phase, and name “Organ transport device with document compartment and anti-tampering seal”.

Background Art

Documents, such as medical records, may be used for various reasons in conjunction with an organ or tissue being stored, transported, evaluated, and/or processed in a perfusion device. Typically, these documents are transported simultaneously with the organ or tissue and are transported separately and/or are accessible externally. Additionally, the device used to transport the organ or tissue and the device used to transport the documents can be freely opened during transport.

The above-discussed approach to storing and protecting organs or tissues and related documentation has certain drawbacks. If the documentation is altered or unavailable, a doctor or clinician may refuse to use the organ or tissue because the necessary information may not be available or may be of questionable authenticity.

A device has been disclosed in which documents are transported in an external compartment of the device and can be accessed when the device is closed. See U.S. Patent No. 6,673,594 to Owen et al. However, external access to documents increases the possibility of unauthorized alteration of information contained in the documents or loss of the documents. Organ or tissue containers that are opened during storage or transport may become contaminated, and the organ or tissue may be exposed to environmental conditions that are harmful to the vitality and health of the organ or tissue. These problems may jeopardize the health of the organ or tissue and the ultimate success of the surgery in which the organ or tissue is used.

Summary of the Invention

For convenience, as used herein, the term "organ" is intended to encompass both organs and/or tissues, unless otherwise specified. The perfusion device may include an internal document compartment and/or may provide a tamper-evident closure. Such a device can reduce costs, save space, provide convenience, and increase the security of the organ and associated documents. A device that carries the organ and documents can provide increased convenience because both the organ and the documents can be accessed internally within the same device. Thus, the device minimizes the possibility of the documents and organ being separated from each other or accessed separately. The documents for the organ are retained in the same device as the organ to ensure that the doctor or clinician using the organ receives appropriate organ information for use, such as for transplantation, evaluation, and/or testing. Because the documents are located inside the device, they can be accessed externally. This can prevent unauthorized changes to the information in the documents and reduce the possibility of loss. Thus, the device provides increased security for the documents and organ during transport.

The device may include one or more tamper-evident closures to protect the organ, documentation, and/or perfusion circuit. The tamper-evident closure may alert the user that the device has been opened at an unauthorized time and/or location and/or by an unauthorized person. Additionally, based on this information, a physician or clinician may perform appropriate diagnostics to determine whether the organ is still acceptable for use before conducting further testing. Thus, the tamper-evident closure may mitigate risks to the health of the organ and the ultimate success of the surgery in which the organ is used. The tamper-evident closure may be provided on any feature that can be opened. Preferably, the tamper-evident closure is provided on a cap or cover to indicate whether the cap or cover has been opened.

BRIEF DESCRIPTION OF THE DRAWINGS

Example implementations may be described with reference to the accompanying drawings, in which:

FIG1 shows a schematic diagram of a perfusion device, a transport device and/or a storage device for an organ.

FIG2 shows an exemplary perspective view of the device of FIG1 with the first outer cover (lid) open;

FIG3 illustrates an exemplary top view of the apparatus of FIG2 with the first and second outer covers (caps) removed;

FIG4 illustrates an exemplary cross-sectional perspective view of an interior compartment of the device taken along line 4-4 of FIG3;

FIG5A illustrates an exemplary perspective view of the perfusion device in a closed position;

5B illustrates an exemplary perspective view of the first and second latches of FIG. 5A , with the first latch in a closed position and the second latch in an open position;

FIG5C illustrates an exemplary cross-sectional view of the first latch in a closed position taken along line 5C-5C of FIG5A; and

5D illustrates an exemplary cross-sectional view of the second latch in an open position, taken along line 5D-5D of FIG. 5A .

DETAILED DESCRIPTION

An exemplary embodiment includes a perfusion device having: a perfusion circuit configured to perfuse an organ or tissue; a compartment in which the organ or tissue can be supported during perfusion by the perfusion device; an inner cover configured to close the compartment; a first outer cover configured to close the perfusion device; and a wall portion extending substantially perpendicularly from the inner cover toward the first outer cover to define a document compartment between the inner cover, the first outer cover, and the wall portion. The perfusion circuit can be configured such that a bottom surface of the first outer cover can be adjacent to a top surface of the wall portion to substantially enclose the document compartment. The wall portion preferably includes four wall portions defining a rectangular document compartment, wherein the interior dimensions of the document compartment can be large enough to incorporate standard size documents, such as A4, ⁸ _1/2 × 11", or ₈ ^1/2 × 13" documents. For example, the document compartment can be at least 0.1 × 9 × 12 inches. Preferably, the document compartment can be at least 0.5 × 9 × 12 inches. More preferably, the document compartment may be at least 0.9 x 9.8 x 12.3 inches. The pouring device may also include a second outer cover configured to cooperate with the first outer cover to close the pouring device and arranged such that the document compartment does not open when the first outer cover is closed, regardless of whether the second outer cover is open or closed.

Exemplary embodiments may include an apparatus for at least one of perfusion, storage, evaluation, processing, and transport of an organ or tissue. The apparatus may include a perfusion circuit configured to perfuse the organ or tissue, a first outer cover configured to close the apparatus, and a first tamper-evident seal. The first tamper-evident seal may, in an initial state, be located on a surface of the first outer cover and a surface that is not part of the first outer cover while the first outer cover is in a closed position, and at a position that will not allow the first outer cover to be opened without changing the initial state of the first tamper-evident seal. The first tamper-evident seal indicates whether the first outer cover has been opened after the first tamper-evident seal has been activated. The apparatus may include: a compartment in which an organ or tissue may be supported during perfusion by the apparatus; an inner cover configured to close the compartment; and a second tamper-evident seal. The second tamper-evident seal may, in an initial state, be located on a surface of the inner cover and a surface that is not part of the inner cover while the inner cover is in a closed position, and at a position that will not allow the inner cover to be opened without changing the initial state of the second tamper-evident seal. The second tamper-evident seal indicates whether the inner cover has been opened after the second tamper-evident seal has been activated. The device may include a second outer cover configured to cooperate with the first outer cover to close the device and a third tamper-evident seal. The third tamper-evident seal may be initially located at a surface of the second outer cover and a surface that is not part of the second outer cover while the second outer cover is in the closed position, and at a position that will not allow the second outer cover to be opened without changing the initial state of the third tamper-evident seal. The third tamper-evident seal indicates whether the second outer cover has been opened after the third tamper-evident seal has been activated.

An exemplary implementation may include a method for storing and/or transporting an organ or tissue and associated documentation. The method may include placing the organ or tissue in a compartment within a perfusion device having a first outer cover configured to close the perfusion device; and placing the documentation within the perfusion device at a position beneath the first outer cover when the first outer cover is closed. The first outer cover may then be closed, and the perfusion device containing the organ or tissue and documentation may be stored or transported without opening the first outer cover.

Exemplary implementations may include a method for reliably storing and/or transporting an organ or tissue in a perfusion device. The method may include activating an inner tamper-evident seal after placing the organ or tissue in a compartment in the perfusion device and closing the compartment with an inner cover, wherein the inner tamper-evident seal indicates whether the inner cover has been opened after the inner tamper-evident seal has been activated. The method may include activating a first outer tamper-evident seal after placing a document in the perfusion device and closing a first outer cover, wherein the first outer tamper-evident seal indicates whether the first outer cover has been opened after the first outer tamper-evident seal has been activated. The method may include: closing the perfusion device with a second outer cover that cooperates with the first outer cover; and activating a second outer tamper-evident seal after closing the second outer cover, wherein the second outer tamper-evident seal indicates whether the second outer cover has been opened after the second outer tamper-evident seal has been activated. After the tamper-evident seal(s) are activated, the method may further include: storing or transporting the perfusion device containing the organ or tissue; and subsequently inspecting the tamper-evident seal(s) to determine whether the corresponding cover(s) have been opened.

These and other features and advantages of the disclosed apparatus and methods are described in or are apparent from the following detailed description of various exemplary implementations.

The following exemplary embodiments may relate to perfusion devices, transport devices, and/or storage devices for organs having a document compartment and/or one or more tamper-evident closures. It should be understood that although exemplary embodiments according to the present disclosure may be suitable for specific applications, the depictions and/or descriptions included in this disclosure are not intended to be limited to any specific application.

The document compartment 160 can hold multiple documents of similar or different types, such as medical records, medical charts, donor information, organ, and/or biological sample data. It may be advantageous to securely store these documents along with the organ in the same device. If the documentation for an organ is lost, the doctor or clinician may refuse to use the organ and/or any results associated with the organ. This is because any procedure using the organ may require: organ data to ensure, for example, the compatibility of the organ with the recipient; a chain of custody to ensure that either the organ or the associated documents have not been tampered with during transport; the identity of the organ and/or biological sample to ensure that the organ is the requested organ; and/or the viability of the organ and/or biological sample to ensure that the organ and/or biological sample are healthy, stable, and ready for use. If the documentation for the biological sample is lost or cannot be associated with the organ, the results of any tests on the biological sample may not be used or may be unavailable because the initial state of the biological sample and its relationship to the organ is uncertain.

FIG1 is a schematic diagram of a perfusion device, transport device, and/or storage device 10 for an organ 20. The organ 20 is preferably a liver, but can be any human or animal, natural or artificial, healthy, injured, or diseased organ or tissue. The device includes a basin 30 in which the organ can be placed. The basin 30 can hold a bracket 60 (as shown in FIG4 ), which preferably includes a surface on which the organ 20 is placed when the organ 20 is in the device 10. The basin 30 may include a first filter that can act as a coarse particle filter. The basin 30 and/or bracket 60 are preferably configured to allow a perfusion fluid bath to be formed around the organ 20. The basin 30 and/or the device 10 may also include one or more temperature sensors 40 located in or near the bracket 60. The basin may include multiple temperature sensors 40 that can provide redundancy in the event of failure and/or can provide temperature measurements at multiple locations. Preferably, the temperature sensor 40 is an infrared temperature sensor. When the organ 20 is disposed in the cradle 60, the temperature sensor(s) 40 are preferably disposed as close to the organ 20 as possible to improve the usefulness and accuracy of the temperature sensor(s) 40, which preferably provide a temperature measurement of the perfusate that can be correlated with the temperature of the organ 20. Alternatively or additionally, the temperature sensor(s) 40 may be used to directly measure the temperature of the organ 20.

The basin 30 is preferably disposed within a cooling container 50, which can contain a cold material such as ice, ice water, saline, or the like. The cooling container 50 can be permanently or removably attached to the apparatus 10 or can be an integral, integral part of the apparatus 10. Thus, in use, the organ 20 is disposed within the cradle 60, which is disposed within the basin 30, which is disposed within the cooling container 50. Preferably, each of the basin 30, cradle 60, and cooling container 50 is constructed or keyed to mate with its corresponding mating component in a single orientation. The configuration of the cooling container 50, basin 30, and cradle 60 can provide a configuration that provides cooling to the organ 20 without requiring the contents of the cooling container 50 to contact the organ 20 or the cradle 60. Although the cooling container 50 is described herein as containing ice or ice water, any suitable cooling medium may be used. Ice may be preferred due to its ready availability, but one of ordinary skill will appreciate that any suitable cooling medium may be employed, which may be an active cooling medium (e.g., a thermoelectric cooler or a refrigerant circuit) or a passive cooling medium such as ice or ice water or a combination thereof. The amount of ice or other cooling medium that can be placed within the cooling container 50 should be determined based on the maximum time that cooling can be provided while the organ 20 is in the apparatus 10.

The bracket 60 may include components configured to securely hold the organ 20 in place. Such components may, for example, include user-selectable netting secured to the bracket 60.

After passing through the filter 32, the perfusate flows along a first flow path 70, which includes a suitable fluid conduit 72 such as flexible or rigid tubing, a pump 80, a pressure sensor 90, a second filter 34, an optional oxygenator 100, and a bubble trap 110, each of which is discussed below.

The first filter 32 is preferably a relatively coarse filter (relative to the second filter 34). Such a coarse filter can be used to prevent large particles, such as byproducts of the organ or the organ removed from the donor, from entering and clogging the fluid path of the apparatus 10. The first filter 32 can be an integral part of the basin 30, or the first filter can be positioned elsewhere in the first flow path 70 downstream of the basin 30. The first filter 32 can also be a separate component from the basin 30 or positioned within the fluid conduit 72.

The first flow path 70 may also include a pump 80. The pump 80 may be any pump suitable for use in conjunction with the perfusion of the organ. Examples of suitable pumps may include manually operated pumps or electric pumps, such as centrifugal pumps or roller pumps. If a roller pump is included, the roller pump may include a single channel or flow path (in which only one tube is compressed by the roller), or the roller pump may include multiple parallel channels or flow paths (in which multiple tubes are compressed by the rollers). If multiple parallel channels or flow paths are included, the rollers may preferably be arranged to be out of phase or offset so that the pulses generated by the rollers are out of phase, which may result in the fluid flow flowing out of the roller pump relatively less pulsating than with a single roller. Such a multi-channel roller pump can achieve a constant flow rate or a flow rate with very little pulsation, which may be advantageous depending on the other components in the flow path and/or the type of organ being perfused.

The flow path 70 may include a pressure sensor 90. The pressure sensor 90 may preferably be disposed after the outlet of the pump 80 so as to monitor and/or be used to control the pressure generated at the outlet of the pump with the aid of a suitable controller. The pressure sensor 90 may provide continuous or periodic pressure monitoring.

The flow path 70 may include an oxygenator 100, such as an oxygenator membrane or body, to provide oxygenation to the perfusate. Oxygen may be provided to the oxygenator 100 by any suitable means. Suitable oxygen sources may include pure oxygen or mixed gases such as air. The gas may be compressed, for example, in a high-pressure cylinder, liquefied (when to be stored in a Dewar flask), or drawn from the surrounding atmosphere. Preferably, the oxygen may be provided by an oxygen generator, which may be separate from or integrated into the apparatus 10. The oxygen may be generated by any suitable means, some examples of which include using molecular sieve pressure swing adsorption, by a ceramic oxygen generator (solid-state oxygen pump), or by decomposition of water.

The flow path 70 may include a bubble trap 110. The bubble trap 110 preferably separates bubbles that may be entrained in the perfusate flow and prevents such bubbles from continuing downstream and entering the organ 20. The bubble trap 110 may also act as an accumulator to reduce or eliminate the pulsatility of the perfusate flow. The bubble trap 110 may initially or through the accumulation of bubbles contain a volume of gas such that pressure fluctuations in the perfusate are dampened or eliminated.

The bubble trap 110 may include a vent that allows for the purging of gas during startup or purging procedures. The vent may be connected to or part of the purge flow path 140. The vent is preferably opened during the startup process so that any air or other gas can be purged from the perfusate path 70. When the vent is open, valves 122 and 132 are preferably both closed. Once the gas is purged from the perfusate path 70, the vent may preferably be closable. The vent may be closed manually or automatically by means of a suitable controller.

The bubble trap 110 can include a level sensor 112. The level sensor 112 can optionally be used during the purge process to determine when the purge is complete and/or can be used to determine when the purge process needs to be repeated, which can occur after gas has been trapped in the bubble trap 110. Additionally, by using the level sensor 112 and the vent, the accumulator function of the bubble trap can be tuned to account for different amplitudes and frequencies of pulsations in the perfusate flow. The accumulator function of the bubble trap can be tuned, for example, by adjusting the volume ratio of air to perfusate fluid.

The bubble trap 110 can have any number of outlets, as required for a given application of the perfusion apparatus. In FIG1 , three outlets are shown connected to three different flow paths, which may be particularly suitable for perfusion of the liver. When perfusing the liver, the three paths preferably include a portal flow path 120 connected to the portal vein of the liver, a hepatic flow path 130 connected to the hepatic artery of the liver, and a bypass flow path 140 providing a return path to the basin 30. A port that allows access to the perfusate solution may also be present in any of the flow paths. This port may preferably be located in the bubble trap 110. This port may preferably include a Luer-type fitting, allowing the user to extract a sample of the perfusate for analysis. This port may also be used by the user to administer medication to the perfusate without opening the basin.

As shown in FIG1 , portal flow path 120 and hepatic flow path 130 may optionally include similar or different components, such as valves 122 , 132 ; bubble sensors 124 , 134 ; flow sensors 126 , 136 ; flow control clamps 127 , 137 ; and pressure sensors 128 , 138 . Each similar component may function in a similar manner, and such paired components may optionally be structurally and/or functionally identical to reduce manufacturing costs. Flow sensors 126 , 136 may preferably be ultrasonic sensors positioned around the tubing, but any suitable sensor may be used. Ultrasonic sensors may be advantageous because, during normal use, such sensors do not contact the perfusate and are therefore not within the sterile path. Such an implementation of an ultrasonic sensor does not require replacement and/or cleaning after use.

Valves 122, 132 may be pinch valves used to clamp the tubing and reduce or shut off flow, but any suitable valve may be used. Pinch valves may be advantageous because, in normal use, they do not contact the perfusate and therefore do not need to be replaced and/or cleaned after use.

Preferably, the bubble sensors 124, 134 are ultrasonic sensors disposed around the tubing, but any suitable sensor may be used. Similar to pinch valves, ultrasonic sensors may be advantageous because, in normal use, they do not contact the perfusate and therefore do not require replacement and/or cleaning after use. Instead, the ultrasonic sensors may be disposed in contact with, adjacent to, or around the outer surface of the tubing to sense air bubbles.

Flow control clamps 127, 137 can be used to fine-tune the flow rate in one or both of the portal flow path 120 and the hepatic flow path 130. Preferably, the organ provides self-regulation to control the flow exiting the bubble trap 110 and distributed between the portal flow path 120 and the hepatic flow path 130. In such self-regulated flow, pressure sensors 128, 138 provide overpressure monitoring. If the pressure delivered to the organ in either or both of the portal flow path 120 or the hepatic flow path 130 exceeds a predetermined threshold, the device 10 can automatically stop and/or reduce the flow rate provided by pump 80 to prevent damage to the organ. Additionally or alternatively, the pressure sensors 128, 138 can be used to generate an alarm signal to the user and/or a suitable controller when the pressure approaches the predetermined threshold. An alternative software algorithm can be used to allow the device 10 to perfuse at a preferred pressure. For example, the software algorithm can allow a physician or clinician to select a specific pressure and change the flow rate accordingly.

After exiting one or both of the portal flow path 120 and the liver flow path 130, the perfusate flows through the organ and returns to the basin 30 to form an organ bath.

Bypass flow path 140 may include a valve 142, and/or sensors such as an oxygen sensor 144 and a pH sensor 146. Preferably, valve 142 is a pinch valve and may have a configuration similar to valves 122 and 132, but any suitable valve may be used. Oxygen sensor 144 and pH sensor 146 may be used to determine the state of the perfusate. Preferably, bypass flow path 140 is used only during the purge or priming process, but it may also be used, preferably continuously, during perfusion to monitor perfusate properties in real time.

The organ perfusion device 10 may also include an accelerometer 150. Preferably, the accelerometer 150 is a three-axis accelerometer, but multiple single-axis accelerometers may also be used to the same effect. The accelerometer 150 may be used to continuously or periodically monitor and/or record the status of the device 10. Monitoring may include monitoring the device 10 for excessive shock and posture. For example, if pitch or roll exceeds a preset alarm limit, the operation of the pump 80 may be momentarily interrupted to stop the flow of perfusate until the specific condition is corrected. By implementing such monitoring, misuse of the device 10 or potentially inappropriate conditions can be detected and recorded, and appropriate measures can be taken.

The apparatus 10 may include storage compartments for items other than the organ 20. For example, the apparatus 10 may include a document compartment 160 for storing documents and/or charts related to the organ 20. Additionally, the apparatus 10 may include one or more sample compartments 170. The sample compartments 170 may be configured to store, for example, fluid and/or tissue samples. The sample compartments 170 may advantageously be positioned adjacent to the coolant container 50 to provide cooling, which may be similar or equivalent to the cooling provided for the organ 20.

Device 10 may include one or more tamper-evident closures 180. Tamper-evident closures 180 may be used to alert a user that device 10 has been opened at an unauthorized time and/or location and/or by an unauthorized person. Tamper-evident closures may alert a user to perform additional testing, screening, etc. before using organ 20 and/or device 10.

Preferably, all components of the apparatus 10 that contact the perfusate and/or organ 20 are disposable and/or easily replaceable. Such disposable items may be included in one or more kits or resaleable packaging. For example, such a kit may include packaging, such as plastic or shrink-wrap packaging, that houses some or all of the components that come into contact with the organ 20 and/or the perfusate. In an embodiment, the tubing, filter, oxygenator, and bubble trap are packaged together in a manner that is preconfigured to be placed within a flow path arrangement of fixed-position components in the apparatus 10, and the bracket and basin are packaged separately or together, and optionally packaged with the tubing, filter, oxygenator, and bubble trap.

FIG2 shows an exemplary perspective view of device 10 with first outer cover 200 open. Compartments, such as inner compartment 300, can be sections of device 10 defined by multiple walls or regions that divide device 10. Compartments can be structurally defined by physical structures within device 10 or functionally divided by the relative positions of components of device 10. A compartment can be defined as a specific enclosure for a group of components that function relative to each other. Compartments can also be defined relative to the position of corresponding covers.

Components under a particular cover can be defined as being in different compartments. For example, the interior compartment 300 can be defined as the area under the first outer cover 200, and the second interior compartment 310 can be defined as the area under the second outer cover 220. Figures 3 and 4 show that the first interior compartment 300 can include at least the basin 30, a portion of the cooling container 50, the tray 60, and/or the document compartment 160. The second interior compartment 310 can include the pump 80, the bubble trap 110, and other components used to perfuse the organ 20 in the apparatus 10.

1 , the overall container for the organ perfusion apparatus 10 can hold many components within a small volume. Therefore, space for documentation and/or tamper evident closures is preferably reserved and allocated in a particularly efficient manner in the embodiments described herein.

The document compartment 160 can be positioned within the first interior compartment 300 between the first outer cover 200 and the inner cover 210. Preferably, the space between the first outer cover 200 and the inner cover 210 defines the document compartment 160. This arrangement allows the documents carried by the document compartment 160 to be accessible only within the compartment. This configuration also provides a means for limiting access to documents and/or the organ 20 to authorized personnel.

The wall portion 230 may extend substantially perpendicularly from the top surface of the inner cover 210 and/or the bottom surface of the first outer cover 200. A plurality of flanges 250 may support the wall portion 230. The wall portion 230 may be integral to the cover, or they may be separate parts that are connected to the cover during assembly. For example, the wall portion 230, the plurality of flanges 250, and the inner cover 210 may be injection molded as a single part. Alternatively, the wall portion 230 and the plurality of flanges 250 may be manufactured separately from the inner cover 210 and mounted to the inner cover 210 by any suitable means, such as an adhesive or fasteners. Thus, the document compartment 160 is defined between the first outer cover 200, the inner cover 210, and the wall portion 230.

Preferably, there are at least four wall sections 230 on the inner cover 210. More wall sections 230 (e.g., six shown in FIG. 3 ) and various lengths and heights can be used to more efficiently enclose documents. Any or all of the wall sections 230 shown can be connected to form a continuous structure without one or more of the gaps shown. A height of 0.1-1 inch (e.g., 0.5-0.9 inch) is ideal for accommodating organ documents. The wall sections 230 can, for example, define rectangular or square document compartments, wherein the interior dimensions of the document compartments are large enough to accommodate standard-sized documents. The wall sections 230 can be positioned to accommodate standard-sized (e.g., A4, ⁸ _1/2 × 11", 8 ^1/2 × ₁₃ ") or any other suitable-sized paper documents. For example, the interior dimensions of the wall section 230 can be at least 9 × 12 inches or alternatively 9 × 15 inches. Preferably, the interior dimensions of the wall section 230 can be at least 0.9 × 9.8 × 12.3 inches. The additional space between the document and the interior lateral dimensions of the document compartment may be beneficial for handling purposes, such as efficiently placing or removing documents from the document compartment 160. The wall portion 230 may serve as a side surface of the document compartment 160, and the top surface of the inner cover 210 may form the bottom interior surface of the document compartment 160. The wall portion 230 may advantageously control the movement of documents in the document compartment 160 to minimize movement of and damage to the documents during handling and transport of the device 10.

When the first outer cover 200 closes the first interior compartment 300, the document compartment 160 can be closed. Thus, the bottom surface of the first outer cover 200 can be the top interior surface of the document compartment 160. In this configuration, documents that can be placed in the document compartment 160 are less likely to be displaced. The bottom surface of the first outer cover 200 can contact or approach the top surface of the wall portion 230 to substantially close the document compartment 160. The closer these two surfaces are positioned relative to each other, the less likely a document may accidentally leave the document compartment 160 during use and/or transport.

In an alternative implementation, the bottom surface of the first outer cover 200 may include a wall portion 230 that contacts or is proximate to the top surface of the inner cover 210 to substantially close and secure the document in the document compartment 160. The wall portion 230 may be on both the first outer cover 200 and the inner cover 210 in any combination.

The first outer cover 200 and the second outer cover 220 can be positioned above the inner compartments 300 and 310, respectively, and cooperate together to close the entire device 10. Preferably, the first outer cover 200 and the second outer cover 220 can pivot about hinges at opposite ends of the inner compartments 300 and 310, respectively. This configuration can allow the outer covers 200 and 220 to be opened at approximately the center of the top surface of the device 10 or anywhere between the ends of the device 10. The outer covers 200 and 220 can be latched closed and/or together, for example, by a latch 260. Preferably, the latch 260 can include a first latch 260A and a second latch 260B, the first latch 260A closing and locking the first outer cover 200 and the second latch 260B closing and locking the second outer cover 220. The latch 260 can include a locking mechanism to secure the cover(s) in the closed position. The locking mechanism can include, for example, a spring or a pull wire to provide the necessary locking force. Preferably, the latches 260A, 260B drive a rod that rotates to open and close a lock at the side of each of the outer covers 200, 220. This configuration advantageously allows the outer covers 200, 220 to cooperate in opening and closing certain portions of the device 10 independently or together. Alternatively, the outer covers 200, 220 may be hinged along one or more other sides of the device 10 to enable this capability. The inner cover(s) may be held in place by gravity, by friction, by latches, or the like. The inner cover(s) may be hinged to either a surface in the compartment or to the outer cover. If the inner cover is hinged to the outer cover, the outer cover is preferably openable 180°, and the wall portions preferably extend from the lower surface of the outer cover so that they extend upward when the outer cover is fully opened.

The two interior compartments 300, 310 and the corresponding outer covers 200, 220 can be separate and independent from each other, such that when the first outer cover 200 is closed and the second outer cover 220 is open or closed, the document compartment 160 and/or the organ 20 may be inaccessible. This configuration advantageously isolates a portion of the device 10 from opening or closing while maintaining the security of the organ 20 and/or the documents in the document compartment 160. In another configuration, the document compartment 160 can be below the second outer cover 220 and enclosed in the second interior compartment 310.

4 shows that the basin cover 240 can close and seal the basin 30 before, during, and/or after organ transport to maintain a sterile environment for the organ. The basin cover 240 can also advantageously close and seal the basin 30 during and/or after low-temperature machine perfusion. Preferably, the flange of the basin cover 240 can be positioned adjacent to the upper surface of the bracket 60 to minimize movement of the bracket 60 during transport of the apparatus 10.

The basin 30 and/or the basin cover 240 can use a sealing mechanism (e.g., an O-ring and an O-ring groove) to help maintain a sterile environment. This configuration can also prevent fluid from flowing out of the basin 30. The first internal compartment 300 and/or the inner cover 210 can also be configured with a sealing mechanism to provide an auxiliary or backup seal. The inner cover 210 can also be used to help maintain a sterile environment for the organ 20 and provide increased safety. If the sealing mechanism fails, the sealing capabilities of both covers 210 and 240 can improve the reliability of maintaining a sterile environment.

The outer covers 200, 220 may also use similar sealing mechanisms to seal the inner compartments 300, 310, respectively, from contamination and fluid egress. Because the document compartment 160 is preferably located between the first outer cover 200 and the inner cover 210, the document compartment 160 is effectively sealed from external contamination and from the perfusate and/or other substances in the first inner compartment 300. This configuration advantageously protects the documents in the document compartment 160.

Example implementations may incorporate tamper-evident closures 180. For example, it may be beneficial to know whether any documents in the document compartment 160, the perfusion circuit, and/or the organ 20 have been accessed before use of the organ 20. After items such as the cradle 60 holding the organ 20, the perfusion circuit, and/or the documents in the document compartment 160 are placed in the apparatus 10, various tamper-evident closures 180 may be used to protect these items. The following locations of the tamper-evident closures 180 are exemplary, and one of ordinary skill will readily appreciate that other locations and/or quantities are contemplated based on the broad innovative principles discussed herein.

FIG5A shows a tamper evident closure 180A for first outer cover 200 of first interior compartment 300. Tamper evident closure 180A can indicate whether first outer cover 200 has been opened. Tamper evident closure 180A can be on first outer cover 200 and on another surface other than first outer cover 200 so that tamper evident closure 180A can be broken, removed, or otherwise indicate that first outer cover 200 has been opened. For example, FIG5A shows that tamper evident closure 180A can be applied to first outer cover 200 and second outer cover 220. Alternatively or in addition, for example, tamper evident closure 180A can be applied to first outer cover 200 and the body of device 10, such as at 340A and 340B.

FIG3 shows a second tamper evident closure 180B for the inner cover 210. The second tamper evident closure 180B can indicate whether the inner cover 210 has been opened. The second tamper evident closure 180B can be on the inner cover 210 and on another surface other than the inner cover 210 so that the second tamper evident closure 180B can be broken, removed, or otherwise indicate that the inner cover 210 has been opened. For example, FIG3 shows that the second tamper evident closure 180B can be applied to the inner cover 210 and a surface within the first interior compartment 300. Alternatively, the second tamper evident closure 180B can be applied elsewhere on the inner cover 210 and the body of the device 10. Preferably, the second tamper evident closure 180B is not damaged when the first outer cover 200 is opened or closed. Additional tamper evident closures 180 may be applied to the basin cover 240, basin 30, and/or bracket 60 in a similar manner as discussed above for even greater security and protection.

FIG5A shows a third tamper evident closure 180C for the second outer cover 220 of the second interior compartment 310. The third tamper evident closure 180C can indicate whether the second outer cover 220 has been opened. The third tamper evident closure 180C can be on the second outer cover 220 and on another surface other than the second outer cover 220 so that the third tamper evident closure 180C can be disconnected, removed, or otherwise indicate that the second outer cover 220 has been opened. For example, FIG5A shows that the third tamper evident closure 180C can be applied to the second outer cover 220 and the body of the device 10. If the first tamper evident closure 180A is applied to the surfaces of the outer covers 200 and 220, the first tamper evident closure 180A can serve as the tamper evident closure 180 for the first outer cover 200 as well as for the second outer cover 220.

If any of the tamper-evident closures 180 indicates that any of the covers 200, 210, 220 have been opened, the doctor or clinician may be able to diagnose potential problems with the documentation and/or organ 20, perform additional testing on the organ 20, before using and/or rejecting the organ altogether. Thus, the tamper-evident closure 180 provides increased protection and security during transport and/or storage of the organ 20 and associated documentation to increase the safety, efficiency, and likelihood of success in the use of the organ 20.

The tamper evident closure 180 may be of a breakable material and be activated by being connected between any cover and another part of the device 10. The tamper evident closure 180 or the device 10 may alternatively or additionally include one or more electronic sensors 320 that provide information that one or more of the covers 200, 210, 220 have been opened. The electronic sensor(s) 320 may be configured to detect that a cover has been opened. For example, a mechanically actuated switch or a Hall effect sensor may be used. This information may help a doctor or clinician determine when and/or for how long one or more covers have been opened. Information from the electronic sensor(s) 320 may be used to determine whether further testing is needed to diagnose the health and vitality of the organ 20. The electronic sensor(s) 320 may be used in conjunction with other types of tamper evident closures to provide redundancy.

5A illustrates various types of tamper evident closures 180. The following types of tamper evident closures 180 are exemplary, and one of ordinary skill will readily appreciate that other types may be contemplated and implemented in accordance with the broad innovative principles discussed herein.

The tamper-evident closure 180 can include a first collar 340A and a second collar 340B connected by a frangible connector to secure the first outer cover 200 in a closed position. The first collar 340A can be attached to an outer surface of the device 10, while the second collar 340B can be attached to an outer surface of the first outer cover 200. After the first outer cover 200 is closed, the frangible connector can be securely secured to the first collar 340A and the second collar 340B. A broken or removed connector indicates that the first outer cover 200 has been opened. This configuration advantageously provides the tamper-evident closure 180 to the device 10 in a simple, cost-effective, and reliable manner. Alternatively, the first collar 340A can be attached to an outer surface of the second outer cover 220. In this configuration, a broken or removed connector indicates that at least one of the first outer cover 200 and the second outer cover 220 has been opened.

5B, 5C, and 5D illustrate a configuration of a tamper-evident closure 180 in which a breakable connector, such as a zipper collar 330A, can be securely secured to a hole or hook 280A in the first latch 260A and a hole or hook 280A in the latch plate 270A. The latch plate 270A can be secured in a recess in the first outer cover 200 in which the first latch 260A is positioned. A similar configuration can be applied to the second latch 260B, the latch plate 270B, the zipper collar 330B, and the corresponding hole or hook 280B. As shown in FIG5C and FIG5D, the latch plates 270A and 270B can be arranged on alternating sides of the latches 260A and 260B, respectively. A broken or removed zipper collar 330A and 330B indicate that the outer covers 200 and 220, respectively, have been opened. This preferred configuration advantageously provides a tamper evident closure 180 to the device 10 in a discreet yet simple and reliable manner.

The tamper-evident closure 180 can be a label, such as a security label or a label with a barcode. When the first outer cover 200 is in the closed position, the first tamper-evident closure 180A can be applied across the surface of the first outer cover 200 and surfaces that are not part of the first outer cover 200. As discussed above, the tamper-evident closure 180 can be positioned in various locations. The security label and/or barcode can be formed so that it cannot be easily copied. A torn or removed label can indicate that the cover 200, 210, 220 has been opened. The tamper-evident closure can include encoded information, such as in a barcode or magnetic stripe. A doctor or clinician may be able to confirm the information in the barcode of the tamper-evident closure 180 to confirm that the organ 20 and the documentation are in their original state. This unique information can prevent the closure from being copied and applied after unauthorized personnel have opened the device 10.

It should be understood that the various features disclosed above and their other features and functions or alternatives can be advantageously incorporated into many other different devices. In addition, various currently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be made subsequently by those skilled in the art, which are also intended to be encompassed by the present disclosure.

Claims (11)

1. An apparatus for at least one of the perfusion, storage, evaluation, and transport of an organ or tissue, said apparatus comprising: A perfusion circuit, wherein the perfusion circuit is configured to perfuse an organ or tissue; A first outer cover, the first outer cover being configured to shut down the device; A second outer cover, configured to cooperate with the first outer cover to close the device; A compartment in which the organ or tissue can be supported during infusion by the device; An inner cover, configured to close the compartment; A first tamper-evident seal is applied to the first outer cover and the second outer cover, thereby being configured to indicate whether the first outer cover has been opened after the first tamper-evident seal has been activated; and A second tamper-evident seal is configured to indicate whether the inner cover has been opened after the second tamper-evident seal has been activated. 2. The device according to claim 1, characterized in that it further comprises: A third tamper-evident seal is configured to indicate whether the second outer cover has been opened after the third tamper-evident seal has been activated. 3. The device according to claim 1, characterized in that it further comprises: An electronic sensor configured to provide information indicating whether the first outer cover has been opened. 4. The device according to claim 1, characterized in that it further includes an anti-tamper sealing assembly, the anti-tamper sealing assembly comprising: The first ring is attached to the outer surface of the device, excluding the outer surface of the first outer cover. A second ring, the second ring being attached to the outer surface of the first outer cover; and A fragile connector that engages the first collar and the second collar to enable the tamper-evident closure. 5. The device according to claim 1, wherein the first tamper-evident seal is a label. 6. The device according to claim 1, wherein the first tamper-evident seal includes a barcode. 7. A method for preparing organs or tissues for safe transport or storage in a perfusion device, the method comprising: The organ or tissue is placed in a compartment of an infusion device having a first outer cover; After the organ or tissue is placed in the compartment, the compartment is closed by closing the inner cover; The second tamper-evident seal is activated after the inner cover is closed, wherein the second tamper-evident seal indicates whether the inner cover has been opened after the second tamper-evident seal has been activated; The infusion device is shut down by closing the first outer cover and closing a second outer cover that mates with the first outer cover; and After the first outer cover is closed, the first tamper-evident seal is activated, wherein the first tamper-evident seal is applied to the first outer cover and the second outer cover and indicates whether the first outer cover has been opened after the first tamper-evident seal has been activated. 8. The method according to claim 7, characterized in that it further comprises: The third tamper-evident seal is activated after the second outer cover is closed, wherein the third tamper-evident seal indicates whether the second outer cover has been opened after the third tamper-evident seal has been activated. 9. The device according to claim 1, characterized in that, The compartment is the first internal compartment that supports the organ or tissue during equipment perfusion; When the first outer cover is closed, the first internal compartment is located below the first outer cover; The device also includes a second internal compartment; The first outer cover and the second outer cover pivot about hinges at opposite ends of the first inner compartment and the second inner compartment, and open at the center of the top surface of the device. 10. The device according to claim 9, wherein when the second outer cover is closed, the second internal compartment is located below the second outer cover. 11. The device according to claim 1, characterized in that, At least one of the first outer cover and the second outer cover includes a latch; A fragile connector secures the latch to a latch plate, which is fixed to a corresponding one of the first outer cover and the second outer cover.