CN110584744B

CN110584744B - Suction catheter device

Info

Publication number: CN110584744B
Application number: CN201910913732.2A
Authority: CN
Inventors: 李林静; 王昂; 朱国辉
Original assignee: Guangzhou Chuangjing Medical Technology Co ltd
Current assignee: Guangzhou Yijie Medical Technology Co ltd
Priority date: 2019-09-25
Filing date: 2019-09-25
Publication date: 2020-11-10
Anticipated expiration: 2039-09-25
Also published as: CN110584744A

Abstract

An aspiration catheter device is provided, the aspiration catheter device comprising a catheter (100) defining an aspiration lumen, the catheter (100) comprising a distal portion (110), an intermediate portion (120) and a proximal portion (130). The distal section (110) and/or the intermediate section (120) comprises an outer layer and a spring member received within the outer layer, the suction catheter device further comprising a pulling member connected to the spring member, the spring member being capable of being stretched and/or compressed by pulling the pulling member, thereby reducing or increasing the stiffness of the corresponding portion of the catheter (100) in which the spring member is received. The stiffness of the distal and/or intermediate portions of the catheter may be adjustable, which provides for better maneuverability of the aspiration catheter, facilitating the aspiration and/or delivery procedures of the catheter.

Description

Suction catheter device

Technical Field

The present invention relates to interventional medical devices, and more particularly to an aspiration catheter device for removing thrombi from within blood vessels.

Background

Acute ischemic stroke (acute cerebral infarction, generally within 2 weeks of onset) is the most common type of stroke, and is caused by cerebral thrombosis or cerebral tissue hypoxia caused by cerebral vessels blocked by thrombus. Cerebral thrombosis has the characteristics of high morbidity, high disability rate, high mortality rate, high recurrence rate and the like. The treatment methods mainly comprise two main categories of drug thrombolysis and mechanical thrombus removal. However, the effect of pure drug thrombolysis or mechanical thrombus removal is not ideal from the current clinical effect.

The drug mainly used in the drug thrombolytic therapy is recombinant tissue plasminogen activator (rt-PA), which can directly activate the conversion of plasminogen into plasmin, so that fibrin is degraded and the thrombus blocking blood vessels is dissolved. The main problems are that systemic administration is needed, bleeding complications are easy to cause, secondly, the treatment time window is narrow, venous thrombolysis needs to be carried out within 3h of onset of disease, and arterial thrombolysis time window needs to be within 6h of onset of disease, so that the number of patients capable of being treated is greatly limited.

The mechanical thrombus extraction mainly comprises thrombus suction, thrombus extraction by a catcher and laser thrombus crushing. The main problem is that when the embolus is large, the thrombus cannot be taken back by simply sucking the thrombus, or the distal embolus can easily escape in the process of withdrawing the embolus by using a catcher, so that the distal blood vessel is blocked, and more serious adverse reaction is caused.

In the prior art, a thrombus aspiration catheter is generally used, and thrombus is extracted by directly applying negative pressure to the thrombus site along a blood vessel so that the blood vessel can reestablish blood flow dynamics. The hardness of the catheters used for sucking thrombus in the prior art is generally single and non-adjustable, so that the catheters are not favorable for advancing in the blood vessels with complex environment and sucking the thrombus. Yet another disadvantage with conventional aspiration catheters is that the aspiration lumen opening has a fixed cross-sectional area and cannot be increased in size to accommodate larger embolic particles, and conventional aspiration catheter ports are classified as circular and oval. Circular cross-section adapted to fully contact the clot to be aspirated and the thrombus on the straight wall; while an elliptical cross-section is suitable for drawing thrombus at an angle to the catheter, it is not suitable for full contact with the clot directly in front of the tip. Thereby greatly influencing the suction effect of the thrombus.

Accordingly, there is a need for further improvements in the art, and it would be desirable to design a better thrombus removal device.

Disclosure of Invention

The present invention has been made in view of the state of the art described above. The invention aims to provide a suction catheter device with better operability.

There is provided an aspiration catheter device comprising a catheter defining an aspiration lumen, the catheter comprising a distal portion, an intermediate portion and a proximal portion,

wherein,

the distal portion and/or the intermediate portion comprises an outer layer and a spring member received within the outer layer,

the suction catheter device further comprises a pulling member connected to the spring member, the spring member being capable of being stretched and/or compressed by pulling the pulling member, thereby reducing or increasing the stiffness of the corresponding portion of the catheter in which the spring member is housed.

In at least one embodiment, the distal portion has a stiffness that is less than a stiffness of the intermediate portion, at least in a state in which the spring member is not stretched and compressed.

In at least one embodiment, the spring member comprises a first spring member located at the distal portion of the catheter, the puller member comprises a first puller member connected to the distal end of the first spring member, the first spring member is compressed and the stiffness of the distal portion of the catheter is increased when the first puller member is pulled towards the proximal end of the catheter.

In at least one embodiment, the first spring member is a coil spring, a distal end of the first spring member is slidable relative to an outer layer of the distal portion, and a proximal end of the first spring member is fixedly attached to or pressed against the proximal end of the distal portion.

In at least one embodiment, the spring member comprises a second spring member located at least in a middle portion of the catheter, the puller member comprises a second puller member connected to a middle portion of the second spring member, a first portion of the second spring member located on a distal side of the middle portion is stretched to make a stiffness of a corresponding portion of the catheter smaller, and a second portion of the second spring member located on a proximal side of the middle portion is compressed to make a stiffness of a corresponding portion of the catheter larger, when the second puller member is pulled towards the proximal end of the catheter.

In at least one embodiment, the second spring member is a coil spring, the distal end of the second spring member is fixedly connected to the outer and/or inner layer of the intermediate portion, and the proximal end of the second spring member is fixedly connected to or pressed against the proximal end of the intermediate portion or the proximal portion.

In at least one embodiment, the first spring member and the second spring member are different parts of the same spring member, or

The first and second spring members are spring members independent of each other, made of different materials and/or having different pitches and/or wire diameters.

In at least one embodiment, the suction catheter device further comprises an adjustment positioning member and a support member, the pulling member being a pulling wire, one end of the pulling member being connected to the spring member and the other end of the pulling member being connected to the adjustment positioning member, the adjustment positioning member being mounted to the support member, whereby pulling and positioning of the pulling member can be achieved.

In at least one embodiment, the adjustment positioning member comprises: a first adjustment positioning member for controlling the first puller member; and a second adjustment positioning member for controlling the second pulling member, the first and second adjustment positioning members being configured to be capable of pulling and positioning the first and second pulling members, respectively, independently of each other.

In at least one embodiment, the suction catheter device further comprises a puller member guide lumen for receiving and guiding the puller member.

There is provided an aspiration catheter device comprising a catheter defining an aspiration lumen, the catheter comprising a distal portion, an intermediate portion and a proximal portion, a distal end of the distal portion defining an aspiration lumen inlet of the aspiration lumen,

wherein,

the distal portion including an outer layer and a first spring member received within the outer layer, the outer layer of the distal portion including a resilient tubular body of resilient material,

the intermediate portion includes an inner liner, an intermediate layer, and an outer layer, the intermediate layer including a second spring member,

the elastic tubular body and the outer layer of the intermediate portion are made of different materials and/or have different thicknesses, the hardness of the elastic tubular body being less than the hardness of the outer layer of the intermediate portion,

the suction catheter device further comprises:

a first puller member connected to a distal end of the first spring member, the first spring member being compressible by pulling the first puller member, thereby increasing a stiffness of the distal portion of the catheter; and

a second pulling member connected to the second spring member, the second pulling member being capable of causing at least a portion of the second spring member to be stretched by pulling the second pulling member or displacing at least a portion of the second spring member relative to the intermediate portion such that the second spring member is absent from a portion of a section of the intermediate portion, thereby reducing a stiffness of a corresponding portion of the intermediate portion.

In at least one embodiment of the present invention, the stiffness of the distal and/or intermediate portions of the catheter is adjustable, which provides for better maneuverability of the aspiration catheter, facilitating the aspiration and/or delivery procedures of the catheter.

Drawings

Fig. 1 shows a schematic external view of a suction catheter device according to an embodiment of the present invention.

Fig. 2A shows a cross-sectional view of the proximal portion of the aspiration catheter device of fig. 1.

Fig. 2B shows a cross-sectional view of the proximal portion of the aspiration catheter device of fig. 1, with the first and second pull members particularly shown.

Fig. 2C shows a perspective schematic view of the distal portion of the suction catheter device of fig. 1, in which the first pull member is particularly shown in connected relation to the first spring member.

Fig. 3A shows a cross-sectional view of the suction catheter device of fig. 1 in the vicinity of the blocking device, showing the blocking device in an expanded, deployed state.

FIG. 3B shows a cross-sectional schematic view of the suction catheter device of FIG. 1, wherein one example of a puller member guide lumen is schematically shown.

Fig. 4A shows a functional diagram of the spring member of the suction catheter device according to the invention, wherein the first pull member is pulled.

Fig. 4B shows a functional diagram of the spring member of the suction catheter device according to the invention, in which the second pull member is pulled.

Fig. 5A schematically shows an enlarged view of a partial region of the distal end portion of the suction catheter device of fig. 1, showing the first spring member of the distal end portion in an uncompressed state.

Fig. 5B schematically shows an enlarged view of a partial region of the distal end portion of the suction catheter device of fig. 1, showing a state in which the first spring member of the distal end portion is compressed and thrombus or other particles are sucked into the elastic tubular body of the distal end portion.

Description of the reference numerals

100 catheters; 110 a distal portion; 112 a first spring member; 113 an elastic tubular body; 120 a middle portion; 121 an inner liner layer; 122 an intermediate layer; 1221a second spring member; 1221A first portion 1221B second portion; 123 outer layer; 130 proximal section

200 capsule body

300 tube seat

A 400 hardness adjustment mechanism; 410a first pulling member; 410A first puller member guide lumen; 420a second puller member; 420A second puller member guide lumen; 430 a first adjustment positioning member; 440 a second adjustment positioning member; 450 support the member.

Detailed Description

Exemplary embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood that the detailed description is intended only to teach one skilled in the art how to practice the invention, and is not intended to be exhaustive or to limit the scope of the invention.

It is to be understood that the drawings are illustrative only and not restrictive. For ease of illustration and description, certain dimensions are exaggerated, certain components or details are omitted, and not all components are shown in each drawing.

Referring to fig. 1 to 4B, one embodiment of the present invention provides an aspiration catheter device, particularly having an elongated configuration. The aspiration catheter device may be, but is not limited to, used to remove thrombi or other particles from within a blood vessel.

The suction catheter device comprises a catheter 100 and a suction device (not shown). Optionally, the suction catheter device may further comprise a blocking device. In one example, the barrier device includes a bladder 200.

< catheter >

In one example, different portions of the catheter 100 in the length direction have different stiffness. In one example, the distal portion 110 of the catheter 100 has a durometer that is less than the durometer of the middle portion 120 of the catheter 100. In one example, the distal portion 110 is part of the anterior side of the balloon 200 described above.

In one example, the catheter 100 has, at least in part, a multi-layered structure. In one example, the middle portion 120 of the catheter 100 includes an inner liner 121, an intermediate layer 122, and an outer layer 123. In one example, the intermediate portion 120 and the proximal portion 130 of the catheter 100 have the same construction, i.e., the intermediate portion 120 and the proximal portion 130 each include an inner liner 121, an intermediate layer 122, and an outer layer 123.

As an example, PTFE (polytetrafluoroethylene), HDPE (high density polyethylene), or a nylon elastomer (e.g., PEBAX, block polyether amide resin) mixed with an additive for reducing a friction coefficient may be used for the inner liner 121, which may reduce friction between a component (e.g., the second spring member 1221 described later) contacting the inner liner 121 and possibly moving relative thereto and the inner liner 121.

As an example, the outer layer 123 may employ a nylon elastomer (e.g., PEBAX), nylon, or PU (polyurethane).

As an example, the intermediate layer 122 may be made of stainless steel wire, nitinol wire, cobalt-chromium alloy wire, or high strength polymer wire having a diameter or thickness of 10 to 200 μm. The wire-like materials can be used to form a coiled spring structure, or the wire-like materials can be used to form a braided structure, or the coiled spring is coiled and then braided to form a composite intermediate layer structure. Therefore, the flexibility of the catheter in the conveying process is guaranteed, the blood vessel wall is not damaged, meanwhile, the middle layer provides proper pushing force, and the distal end of the catheter can be well conveyed to a desired part of the blood vessel, such as a pathological change part.

In one example, the stiffness of the intermediate portion 120 of the catheter 100 tapers from the proximal end to the distal end. Alternatively, this can be achieved by changing the thickness of the material and/or changing the weave pattern, in particular of the intermediate layer, or the pitch of the spring.

In one example, the intermediate layer 122 includes a spring member (second spring member 1221) that may be stretched and/or compressed along the length of the catheter 100 relative to other portions of the intermediate layer (e.g., the braid, if any) and the inner and

outer layers

121, 123, thereby changing the pitch of the spring at different locations of the intermediate layer 122 and thus changing the stiffness at different locations of the intermediate layer 122. In at least one example of the invention, the stiffness may be associated with bendability, i.e., the stiffer the catheter is, the less stiff the more easily the catheter is, the less stiff the catheter is.

In this example, if the intermediate layer also includes other portions such as a woven layer, the woven layer may optionally be adhered or affixed to the inner liner 121 or outer layer 123.

In at least one example, the spring members (the first and

second spring members

112 and 1221 described below) may be coil springs.

The distal portion 110 of the catheter 100 may have a multi-layered structure. In one example, an outer layer of the distal portion 110 includes an elastic tubular body 113, and the distal portion 110 further includes a first spring member 112 received within the outer layer. In one example, the flexible tubular body 113 forms an outer layer of the distal portion 110 and the first spring member 112 forms an inner layer of the distal portion 110. The flexible tubular body 113 of the distal portion 110 may be selected from any biocompatible material or combination of materials, examples of which include thermoplastic polyurethane, silicone elastomer, and natural or synthetic rubber in a viscous form, among others.

The distal portion 110 includes an elastic tubular body 113, and during aspiration of thrombus by the catheter 100, the elastic tubular body 113 may become larger in radial dimension as the thrombus enters, for example, may be expanded by the entered thrombus to abut against the vessel wall, thereby increasing aspiration and containment capabilities of the thrombus.

The distal portion 110 comprises a tubular structure (the elastic tubular body 113) made of a highly elastic material, which forms a certain envelope with the thrombus as it is sucked, so as to prevent the problem that the thrombus falls off or small blood clots are formed to escape during the retraction of the conventional suction catheter.

In one example, the length of the flexible tubular body 113 of the distal portion 110 can be 3mm to 30 mm.

A catheter suction lumen is formed inside the catheter 10, and one end (distal end, end for suctioning, for example, thrombus) of the catheter 100 forms a suction lumen inlet and the other end forms a suction lumen interface, which is connected to the tube holder 300. The distal portion 110 defining the suction lumen inlet is formed as a composite tubular structure of a resilient tubular body 113 and a first spring member 112. The first spring member 112 acts as a stent support relative to the distal end structure of a single elastomeric material, preventing the single elastomeric material from collapsing or retracting during aspiration, resulting in an unsmokable condition.

In a preferred example, the hardness of the distal portion 110 is adjustable. This may be achieved by varying the pitch of the first spring member 112. In particular, by compressing the first spring member 112 such that its pitch is reduced, support to the resilient tubular body 113 can be enhanced, thereby increasing the stiffness of the spring-containing portion of the distal section 110.

< hardness adjustment mechanism >

As mentioned above, the stiffness of both the distal portion 110 and the intermediate portion 120 of the catheter 100 is preferably adjustable. In one example, the aspiration catheter device includes a stiffness adjustment mechanism 400.

The structure and operation of the hardness adjustment mechanism 400 will be described below. Referring to fig. 2A-2C, the stiffness adjustment mechanism 400 includes a first puller member 410 and a second puller member 420, embodied, for example, as puller wires. Preferably, the firmness adjustment mechanism 400 further includes first and second

adjustment positioning members

430 and 440 and a support member 450. Support member 450 is connected to proximal portion 130 of catheter 100 or to hub 300. The first and second

adjustment positioning members

430 and 440 are mounted to the support member 450.

A first puller member 410, which may be embodied as a puller wire, has one end attached to the distal end of the first spring member 112 and another end attached to the first adjustment positioning member 430. The proximal end of the first spring member 112 may be fixed in position relative to the catheter 100, in particular may be fixedly connected to or pressed against the proximal end of the resilient tubular body 113 of the distal part 110.

As the first puller member 410 is pulled by the first adjusting positioning member 430, the first puller member 410 pulls the distal end of the first spring member 112 toward the proximal end of the catheter 100, thereby compression stiffening the first spring member 112.

Fig. 5A schematically illustrates an enlarged view of a partial region of the distal end portion 110, which shows the first spring member 112 in an uncompressed state. Fig. 5B schematically illustrates a state in which the first spring member 112 of the distal end portion 110 is compressed and thrombus or other particles 500 are drawn into the elastic tubular body 113 of the distal end portion 110. In fig. 5A and 5B, the first pulling member 410 is not shown.

In one example, the distal end of the first spring member 112 can slide relative to the distal end of the resilient tubular body 113. Upon pulling the distal end of the first spring member 112, the elastic tubular body 113 is not compressed with the first spring member 112, and the distal end of the first spring member 112 is spaced a distance from the distal end of the elastic tubular body 113, which facilitates softening, deforming, and aspiration of thrombus by the distal end of the elastic tubular body 113.

In one example, as shown in fig. 5A and 5B, the outer diameter of the first spring member 112 is substantially equal to the inner diameter of the resilient tubular body 113 such that the first spring member 112 abuts the inner wall of the resilient tubular body 113 to facilitate the first spring member 112 providing support for the resilient tubular body 113 without impeding compression of the first spring member 112.

In one example, as shown in fig. 5A and 5B, the distal end of the first spring member 112 and the distal end of the elastic tubular body 113 are substantially flush before the first spring member 112 is pulled in compression. After the elastic tubular body 113 bears against or partially aspirates the thrombus, the first spring member 112 may be pulled, at which time the distance between the distal end of the first spring member 112 and the distal end of the elastic tubular body 113 (the compressed length of the first spring member 112) may be, for example, 1mm to 20mm, and particularly, 1mm to 10 mm. The resilient tubular body 113 has a strong expansion capability, and after the first spring member 112 is compressed, the resilient tubular body 113 can expand to adhere to the vessel wall under the action of the aspirated thrombus or other particles 500, which increases the aspiration capability and the ability to contain the thrombus.

It should be understood that the shape of the thrombus or other particle 500 and the shape of the deformed elastic tubular body 113 in fig. 5B are merely exemplary, that the elastic tubular body 113 may be asymmetrically and more smoothly deformed, and that the elastic tubular body 113 may simultaneously imbibe one or more thrombus or other particles 500.

Pulling the first pulling member 410 via the first adjusting positioning member 430 may decrease the pitch and length of the first spring member of the distal portion of the catheter 100, making the distal portion 110 stiffer, which may solve the problem of some flexible catheters collapsing and deforming during aspiration. The increase of the hardness enhances the radial supporting force of the catheter in the thrombus suction process, and can better complete the thrombus removal.

In one example, the first adjusting positioning member 430 can be rotatably mounted to the support member 450, and the amount of winding of the first pulling member 410 on the first adjusting positioning member 430 can be changed by rotating the first adjusting positioning member 430 to effect pulling and releasing of the first pulling member 410.

In another example, the first adjusting positioning member 430 can be slidably mounted to the support member 450, and pulling and releasing the first pulling member 410 can be accomplished by sliding the first adjusting positioning member 430 over the support member 450.

Of course, the present invention is not limited thereto. In another example, the pulling and releasing of the first pulling member 410 may be accomplished by a pulling device provided separately from the catheter 100. In another example, the first puller member 410 can be pulled and released manually.

Fig. 4A shows a comparison of the first pulling member 410 before and after it is pulled. The left side of fig. 4A illustrates a state in which the first spring member 112 is compressed after the first drawing member 410 is drawn, and the right side of fig. 4A illustrates a state in which the first spring member 112 is not compressed before the first drawing member 410 is drawn.

In fig. 4A, the first spring member 112 and the second spring member 1221 are different portions of the same spring. In other embodiments, the first spring member 112 and the second spring member 1221 may be different springs. The first and

second spring members

112, 1221 may be formed of different materials, may have different wire diameters and/or pitches, and thus the first and

second spring members

112, 1221 may provide different stiffness and support.

As shown in fig. 4A and 5B, the distal end of the first spring member 112 is pulled by the first pulling member 410, which is primarily manifested as the first spring member 112 being compressed, the pitch and length being reduced, due to the proximal end of the first spring member 112 being secured to the catheter 100.

As shown in fig. 4B, the second pulling member 420, which may be embodied as a pulling wire, has one end connected to a middle portion (not necessarily the midpoint) of the second spring member 1221 and the other end connected to the second adjusting positioning member 440. Alternatively, the distal and proximal ends of the second spring member 1221 may be positionally fixed relative to the catheter 100.

When the second pulling member 420 is pulled by the second adjusting positioning member 440, the second pulling member 420 pulls the middle portion of the second spring member 1221 toward the proximal end of the catheter 100, so that the pitch and length of the first portion 1221A of the second spring member 1221 on the distal side of the middle portion become larger and the stiffness and supporting ability become smaller, and at the same time, the pitch and length of the second portion 1221B of the second spring member 1221 on the proximal side of the middle portion become smaller and the stiffness and supporting ability become larger.

By increasing the pitch of the first portion 1221A of the second spring member 1221, the stiffness of the portion of the middle portion 120 of the catheter 100 corresponding to the first portion 1221A (the first portion/distal portion of the middle portion 120 of the catheter 100) can be made smaller, flexibility can be improved, delivery of the catheter 100 in a blood vessel is facilitated, a target site at the distal end of the blood vessel is easily reached, and damage to the blood vessel wall can be reduced.

The second regulation positioning member 440 may have the same or different structure as the first regulation positioning member 430. Here, the second regulation positioning member 440 will not be described in detail.

Figure 4B shows a comparison of the second puller member 420 before and after it is pulled. The left side of fig. 4B illustrates a state in which the first portion 1221A of the second spring member 1221 is stretched and the second portion 1221B is compressed after the second pulling member 420 is pulled, and the right side of fig. 4A illustrates a state in which the second spring member 1221 is not stretched and compressed before the second pulling member 420 is pulled.

It should be understood that the lengths of the spring members and the connection positions of the pulling members and the spring members in fig. 4A and 4B are only schematic and are only used for explaining the operation principle and the operation mode of the spring members, and do not necessarily represent the actual lengths of the spring members and the connection positions of the pulling members and the spring members.

A lubricious coating may be applied to the first and

second spring members

112, 1221 and/or the first and

second puller members

410, 420, and the coating may be, for example, a PTFE coating or a hydrophilic coating or a hydrophobic coating. This may reduce friction between the relatively moving members.

As described above, the stiffness adjustment mechanism 400 of the present invention can adjust the stiffness and bendability of the distal portion 110 and the middle portion 120 of the catheter, and in particular, the distal portion 110 of the catheter can be stiffened by compressing the first spring member 112 and a section of the middle portion 120 of the catheter 100 can be softened by pulling the second spring member 1221.

It will be appreciated that the second spring member 1221 may be used to adjust the stiffness of the intermediate portion 120 of the catheter 100 during delivery of the catheter 100 to the thrombus portion, while the first spring member 112 may be used to adjust the stiffness of the distal portion of the catheter 100 during aspiration of thrombus and withdrawal of the catheter 100.

It should be understood that the invention is not limited to the specific examples given above. For example, in one example, the distal end of the second spring member 1221 is not fixed to the catheter 100 (outer layer 123 or inner liner 121) but is displaceable relative to the catheter 100 (outer layer 123 and inner liner 121), at which point at least a portion of the catheter 100 appears to have no corresponding spring member when the second pulling member 420 is used to pull the second spring member 1221, thereby becoming less stiff. In this example, the second puller member 420 can also be coupled near the distal end of the second spring member 1221.

In another example, the position of the proximal end of the second spring member 1221 is not fixed, so that when the second pulling member 420 is used to pull the second spring member 1221, the spring portion on the proximal side of the intermediate portion is mainly displaced without being significantly compressed, and thus, it is possible to avoid the stiffness of this portion from becoming large.

The number of puller members of the present invention is also not limited to two, but rather there may be more puller members attached to the spring member at different locations, thereby allowing adjustment of stiffness and bendability for more sections of the spring member and catheter. Correspondingly, the spring member is not limited to the first spring member 112 and the second spring member 1221 described above, but may include more spring members, or may be appropriately positioned at more positions.

< guide Chamber >

Figure 3B schematically illustrates one example of a puller member guide lumen. In this example, taking the intermediate portion 120 of the catheter as an example, a first puller member guiding lumen 410A is formed in the catheter 100 for at least partially receiving and guiding the first puller member 410, which first puller member guiding lumen 410A may be formed, for example, on the liner layer 121. The distal end portion 110 may be formed without a guide lumen or with a guide lumen formed in the elastic tubular body 113 for receiving and guiding the first puller member 410.

A second puller member guiding lumen 420A may also be formed in the catheter 100 for at least partially receiving and guiding the second puller member 420, which second puller member guiding lumen 420A may be formed, for example, on the inner liner 121 or the outer layer 123.

Where the first puller member guiding lumen 410A and the second puller member guiding lumen 420A are formed in the liner layer 121, the two guiding lumens may also be formed as the same guiding lumen extending along the length of the catheter 100.

In one example, the aspiration catheter device also includes a guidewire, and thus, a guidewire lumen may also be formed in the catheter 100.

< blocking means >

In one example of the present invention, the blocking device may include a balloon 200, and accordingly, a balloon inflation channel may be formed in the catheter.

The balloon 200 may be disposed proximal to the distal portion 110 of the catheter, adjacent the distal portion 110. The balloon 200 may be a spherical (annular) inflatable balloon. When not pressurized, the balloon 200 is not increased in diameter at the location, which may be equal to or slightly larger than the diameter of the surrounding catheter. When the balloon 200 is inflated, particularly when the catheter 100 is withdrawn, as shown in fig. 3A, the balloon 200 can block the proximal end of the thrombus, thereby reducing the blood flow impact pressure on the thrombus and facilitating the withdrawal of the thrombus. It should be understood that fig. 3A is only intended to illustrate the inflated bladder 200 and thus some components and structures are omitted.

In one example, the inflated balloon 200 may be 5mm to 30mm in length and 5mm to 20mm in diameter.

The material of the capsule body 200 may be polyamide elastomer material, silicone rubber material or polyurethane material.

The balloon 200 may be inflated and the inflated state of the balloon 200 maintained by providing a separate lumen (balloon inflation channel) in the catheter 100 and interfacing with a one-way valve at the proximal end of the catheter. The lumen (balloon inflation channel) may be formed, for example, between inner liner 121 and outer layer 123. Of course, the lumen (balloon inflation channel) may also be formed in the outer layer 123.

Balloon 200 may be attached to outer layer 123 of the distal end of intermediate portion 120. In one example, the unexpanded bladder 200 can be received by reducing the thickness of the outer layer. Bladder 200 may be in communication with the bladder inflation channel by making a hole in outer layer 123.

In another example, the barrier member comprises a cylindrical braided structure made of, for example, a memory alloy material, and an elastic membrane may be coated or adhered to an outer surface or an inner surface of the braided structure. The column of braided material is attached to the outer layer 123 of the catheter 100 without substantially increasing the diameter of the catheter when the column of braided material is in a collapsed state. When the cylindrical braid material is expanded and deployed, at least a portion thereof becomes larger in diameter, thereby functioning similarly to the above-described balloon 200. The expanding deployment of the blocking member may be achieved by, for example, pulling a wire or electrically fusing a material.

< socket >

At the proximal end of catheter 100, hub 300 is attached, and hub 300 may include or may be attached to an aspiration device for negative pressure aspiration of thrombus on hub 300.

A steering assembly, which may include an operating handle, which may include a gripping handle, push-pull button, etc., may also be provided at the proximal end of hub 300 or catheter 100.

< marker >

A distal portion 110 of catheter 100 may be provided with a radiopaque marker, which may be configured as a visualization loop or a visualization coil. This facilitates the physician to determine the position of the catheter 100 by monitoring the position of the radiopaque markers with a vascular imaging device, such as a DSA.

It should be understood that the above embodiments are only exemplary and are not intended to limit the present invention. Various modifications and alterations of the above-described embodiments may be made by those skilled in the art in light of the teachings of the present invention without departing from the scope thereof.

Claims

1. An aspiration catheter device comprising a catheter (100) defining an aspiration lumen, the catheter (100) comprising a distal portion (110), an intermediate portion (120) and a proximal portion (130), a distal end of the distal portion (110) defining an aspiration lumen inlet of the aspiration lumen,

it is characterized in that the preparation method is characterized in that,

the distal portion (110) comprising an outer layer and a first spring member (112) received within the outer layer, the outer layer of the distal portion (110) comprising an elastic tubular body (113) of an elastic material,

the middle portion (120) comprises an inner lining layer (121), a middle layer (122) and an outer layer (123), the middle layer (122) comprises a second spring member (1221),

the elastic tubular body (113) and the outer layer (123) of the intermediate portion (120) are made of different materials and/or have different thicknesses, the hardness of the elastic tubular body (113) being less than the hardness of the outer layer (123) of the intermediate portion (120),

the suction catheter device further comprises:

a first pulling member (410) connected to a distal end of the first spring member (112), the first spring member (112) being compressible by pulling the first pulling member (410), thereby increasing a stiffness of the distal portion (110) of the catheter (100); and

a second pulling member (420) connected to the second spring member (1221), at least a portion of the second spring member (1221) being capable of being stretched by pulling the second pulling member (420) or displacing at least a portion of the second spring member (1221) relative to the middle portion (120) such that the second spring member (1221) is absent from a portion of a section of the middle portion (120), thereby reducing a stiffness of a corresponding portion of the middle portion (120).

2. The suction catheter device according to claim 1,

the distal portion (110) has a stiffness that is less than a stiffness of the intermediate portion (120) at least in a state where the first spring member (112) and the second spring member (1221) are not stretched and compressed.

3. The suction catheter device according to claim 1 or 2, characterized in that the first spring member (112) is a helical spring, a distal end of the first spring member (112) being slidable relative to an outer layer of the distal section (110), a proximal end of the first spring member (112) being fixedly connected to or pressed against a proximal end of the distal section (110).

4. The suction catheter device according to claim 1 or 2,

the second pulling member (420) is connected to a middle portion of the second spring member (1221), and when the second pulling member (420) is pulled toward the proximal end of the catheter (100), a first portion (1221A) of the second spring member (1221) on the distal side of the middle portion is stretched to make the hardness of the corresponding portion of the catheter (100) smaller, and a second portion (1221B) of the second spring member (1221) on the proximal side of the middle portion is compressed to make the hardness of the corresponding portion of the catheter (100) larger.

5. The aspiration catheter device according to claim 4, characterized in that the second spring member (1221) is a helical spring, the distal end of the second spring member (1221) being fixedly connected to the outer layer (123) and/or the inner layer of the intermediate portion (120), the proximal end of the second spring member (1221) being fixedly connected to or pressed against the proximal end of the intermediate portion (120) or the proximal portion (130).

6. The suction catheter device according to claim 4,

the first spring member (112) and the second spring member (1221) are different parts of the same spring member, or

The first spring member (112) and the second spring member (1221) are spring members independent of each other, the first spring member (112) and the second spring member (1221) being made of different materials and/or having different pitches and/or wire diameters.

7. The suction catheter device according to claim 1 or 2,

the suction catheter device further comprises an adjustment positioning member and a support member (450), the first pulling member (410) and the second pulling member (420) being pulling wires, one ends of the first pulling member (410) and the second pulling member (420) being connected to the first spring member (112) and the second spring member (1221), respectively, and the other ends of the first pulling member (410) and the second pulling member (420) being connected to the adjustment positioning member, respectively, the adjustment positioning member being mounted to the support member (450), by which pulling and positioning of the first pulling member (410) and the second pulling member (420) can be achieved.

8. The suction catheter device according to claim 7,

the adjustment positioning member includes: a first adjustment positioning member (430) for controlling the first pulling member (410); and a second adjustment positioning member (440) for controlling the second pulling member (420), the first adjustment positioning member (430) and the second adjustment positioning member (440) being configured to be capable of pulling and positioning the first pulling member (410) and the second pulling member (420), respectively, independently of each other.

9. The suction catheter device according to claim 1 or 2,

the suction catheter device further includes a puller member guide lumen for receiving and guiding the first puller member (410) and the second puller member (420).