CN114681148A

CN114681148A - Valve clamping system, delivery device and release assembly thereof

Info

Publication number: CN114681148A
Application number: CN202011633059.6A
Authority: CN
Inventors: 王刚; 王全园
Original assignee: Shenzhen Jianxin Medical Technology Co ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2020-12-31
Filing date: 2020-12-31
Publication date: 2022-07-01

Abstract

The release assembly comprises an inner tube, a first traction piece, a second traction piece and a mandrel, wherein the first traction piece and the second traction piece respectively comprise a first lantern ring and a second lantern ring, the mandrel can move axially in a tube cavity of the inner tube and penetrates through at least one of the first lantern ring and the second lantern ring, the first traction piece is axially limited on the second traction piece on the mandrel, so that when the second traction piece moves towards the proximal end of the inner tube along with the inner tube, the first traction piece can move towards the proximal end of the inner tube, and when the mandrel is pulled away from the first lantern ring or the second lantern ring along the tube cavity, the second traction piece releases axial traction on the first traction piece. According to the valve clamping system, the conveying device and the release assembly thereof, the release assembly can perform opening and clamping operations of the hooks so as to capture the valve conveniently, the hooks can be released by drawing the mandrel away, and the valve slippage caused by the traction of the hooks in the subsequent drawing-out process is effectively avoided.

Description

Valve clamping system, delivery device and release assembly thereof

Technical Field

The invention relates to the technical field of medical equipment, in particular to a valve clamping system, a conveying device and a release assembly of the valve clamping system.

Background

Mitral valve disease is a common disease in the elderly population, and includes two common types of mitral regurgitation and mitral stenosis, with mitral regurgitation being the most common. The incidence of mitral regurgitation is statistically as high as 10% in people older than 75 years of age. Slight mitral regurgitation generally has no influence on normal life, moderate or severe mitral regurgitation requires intervention treatment, the traditional surgical treatment mode is open chest treatment, and the heart is opened under the support of an extracorporeal circulation machine to repair or replace valves, but high-risk patients cannot tolerate the treatment. The recent emergence of interventional procedures, which typically involve the delivery of instruments through a catheter to the site of a lesion to repair or replace a valve, has created a hope for high risk patients with mitral regurgitation.

At present, transcatheter mitral valve replacement products are mostly in clinical research stages, and transcatheter mitral valve repair products generally adopt a clamping apparatus to clamp two valve leaflets (anterior leaflet and posterior leaflet) of a mitral valve, in order to better clamp the valve leaflets, before a clamping piece clamps the valve leaflets, the valve leaflets are generally clamped and fixed through a clasp so as to be in a stable state, and then the clamping apparatus is operated to clamp and fix the valve leaflets by the clamping piece, so that the valve opening area is reduced, and the purpose of treating regurgitation is achieved.

Disclosure of Invention

In view of the above, the present invention provides a release member that operates and releases a clasp, and a delivery device and a valve clamping system including the release member.

In one aspect, the present invention provides a release assembly comprising:

an inner tube having a lumen extending through a distal end and a proximal end of the inner tube;

a first pulling member comprising a first collar;

a second pulling member, at least partially positioned within the lumen, comprising a second collar; and

a mandrel axially movable within the lumen, at least one of the first and second collars being disposed about the mandrel, the position of the first and second collars relative to the mandrel being configured to: the first traction member is axially constrained to the second traction member by the mandrel such that the first traction member is capable of moving towards the proximal end of the inner tube when the second traction member moves with the inner tube towards the proximal end of the inner tube, and the second traction member releases axial traction on the first traction member when the mandrel is withdrawn along the lumen.

On the other hand, the conveying device provided by the invention comprises a conveying conduit, a pushing assembly and the releasing assembly, wherein the conveying conduit is a multi-cavity conduit and comprises a pushing cavity and at least 2 side cavities, the at least 2 side cavities are distributed on two sides of the pushing cavity, the releasing assemblies are 2 groups, the 2 groups of releasing assemblies respectively penetrate through the at least 2 side cavities and can axially move relative to the conveying conduit, the pushing assembly penetrates through the pushing cavity and is detachably connected with the clamp, and the pushing assembly is used for controlling the opening and closing of the clamp.

In another aspect, the invention provides a valve clamping system, which includes the delivery device.

According to the valve clamping system, the conveying device and the release assembly of the valve clamping system, the release assembly adopts a matching mode of the first sleeve ring and the second sleeve ring relative to the mandrel, so that the first traction piece and the second traction piece can conveniently realize the limit in the axial direction of the mandrel or release the traction of the second traction piece on the first traction piece, the first traction piece can be connected with the clasp, the operation of the second traction piece on the clasp through the first traction piece is realized, when the clasp needs to be released, the mandrel only needs to be pulled away to remove the axial limit of the second traction piece and the first traction piece, the release assembly is simple to operate, the operation time is shortened, the falling risk of the valve is effectively reduced, and the operation success rate is improved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings of the embodiments can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic view of a valve clamping system according to one embodiment;

FIG. 2 is a schematic view of the structure of the clamp of the valve clamping system shown in FIG. 1, illustrating the support arms in a state in which they spread apart the clamping arms, i.e., the first pulling member pulls the corresponding clasps open relative to the support arms;

FIG. 3 is a schematic view of a delivery catheter of the delivery device in one embodiment of the valve clamping system;

FIG. 4 is a schematic view of a pusher assembly of a delivery device in one embodiment of the valve clamping system;

FIG. 5 is a schematic view of a release assembly of a delivery device in one embodiment of the valve clamping system;

FIG. 6 is a schematic view of a release assembly of a delivery device in another embodiment of the valve clamping system;

FIG. 7 is a schematic view of a release assembly of a delivery device in yet another embodiment of a valve clamping system;

FIG. 8 is a schematic view of a release assembly of a delivery device in yet another embodiment of the valve clamping system;

FIG. 9 is a schematic view of the puncture path of the delivery catheter of the delivery device during a valve repair procedure using the valve clamping system;

FIG. 10 is a schematic view of a clip being advanced along a delivery catheter to a valve position during a valve repair procedure using the valve clipping system;

fig. 11 is a schematic view showing that, in the repair operation of the valve by using the valve clamping system, the first pulling member pulls the corresponding clasp to open relative to the support arm to capture the valve leaflet of the valve in the opened state of the clamp;

fig. 12 is a schematic view of the delivery device after the delivery device has been withdrawn after the binder has performed the leaflet binding operation on the valve.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It should be noted that the terms "distal" and "proximal" are used as terms of orientation that are commonly used in the medical device art, wherein "distal" refers to the end that is distal from the operator during operation, and "proximal" refers to the end that is proximal to the operator during operation. Axial, meaning a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; radial, means a direction perpendicular to the above-mentioned axial direction.

Referring to fig. 1, the present invention provides a valve clamping system 100, which comprises a clamp 10 and a delivery device 20. Wherein the delivery device 20 is configured to be removably coupled to the clip 10, such that the clip 10 is delivered to the proper location and released. It should be noted that the delivery device 20 includes a structure for controlling the opening and closing of the clamp 10, so as to control the clamp 10 to clamp the two valve leaflets of the valve, thereby performing the functional repair of the valve.

As shown in fig. 2, the clamping device 10 includes a spacer 11, a fixing seat 12 and a clamping assembly 13. Wherein, centre gripping subassembly 13 includes 2 support arms 131 and 2 centre gripping arms 132, and 2 support arms 131 rotate respectively and connect in the both sides of separating the piece 11, and 2 centre gripping arms 132's one end all is connected with fixing base 12, and the other end rotates with the one end of 2 support arms 131 of keeping away from with the piece 11 and is connected. Through the connection mode, when the fixed seat 12 and the spacing piece 11 move relatively, 2 supporting arms 131 and 2 clamping arms 132 move relatively in an interlocking manner, so that the states of the 2 clamping arms 132 are changed.

Specifically, when the 2 holding arms 132 are in a natural state (i.e., when not being subjected to an external force), the 2 holding arms 132 are held close to each other in a direction of approaching the spacer 11. That is, the 2 clipping arms 132 have a tendency of clipping, so that they can rely on their own clipping force to gather without being acted by external force, and then provide power source for the two leaflets clipping the valve, so that the clipping device 10 can still keep the clipping effect on the two leaflets of the valve after the delivery device 20 is withdrawn.

In some embodiments, 2 clamping arms 132 are integral with the holder 12, for example, after cutting 2 axially extending clamping arms 132 from a nitinol tube, the clamping arms 132 are deflected and shaped away from the axis of the nitinol tube to form 2 clamping arms 132 with an inward gripping tendency.

When the 2 holding arms 132 are clamped together, the 2 supporting arms 131 are folded between the 2 holding arms 132. Specifically, the 2 supporting arms 131 are respectively rotated relative to the 2 holding arms 132 under the clamping force provided by the 2 holding arms 132, so as to be folded between the 2 holding arms 132. Therefore, when the 2 support arms 131 rotate relative to the 2 clamping arms 132 and are opened, the 2 support arms 131 can overcome the clamping force of the 2 clamping arms 132 to drive the 2 clamping arms 132 to be opened, after the clamp 10 is adjusted to a proper position relative to the valve, the 2 support arms 131 are folded relative to the 2 clamping arms 132 by controlling the relative movement of the fixing base 12 and the spacing piece 11, and the leaflet between the clamping arms 132 and the spacing piece 11 is clamped under the clamping action of the 2 clamping arms 132 to complete the leaflet capture.

In some embodiments, when the spacer 11 and the fixing base 12 are axially away from each other, the spacer 11 links the 2 supporting arms 131 to rotate relative to the 2 clamping arms 132, respectively, so that the 2 supporting arms 131 drive the 2 supporting arms 131 to expand away from each other in a direction away from the spacer 11. Correspondingly, when the spacer 11 and the fixing base 12 are close to each other in the axial direction, the 2 clamping arms 132 are clamped toward the spacer 11 under the clamping force of the clamping arms, and simultaneously the 2 supporting arms 131 connected with the clamping arms are linked to be folded and finally abut against the spacer 11. From this, can realize opening and the operation of pressing from both sides of 2 centre gripping arms 132 and draw together through controlling the axial relative position of spacer 11 with fixing base 12, and then catch the leaflet in suitable position department, when catching the position unsatisfactory, through the regulation and control to the axial relative position of spacer 11 and fixing base 12, 2 centre gripping arms 132 open again, again carry out the centre gripping to the leaflet after adjusting to suitable position.

In some embodiments, the spacer 11 includes a proximal connecting portion 11a and a distal connecting portion 11b opposite to each other, and the 2 supporting arms 131 are rotatably connected to the distal connecting portion 11b, so that when the 2 clamping arms 132 drive the 2 supporting arms 131 to be folded toward the direction close to the spacer 11, the 2 supporting arms 131 can be finally clamped on both sides of the spacer 11, and then the 2 supporting arms 131 cannot move further toward each other under the restriction of the spacer 11, and finally reach a stable state, so as to stably clamp the two leaflets of the valve.

In some embodiments, the clip 10 includes a clasp 14 disposed in correspondence with 2 support arms 131. When the hook 14 is not applied with an external force, the hook 14 and the support arm 131 are clamped together, so as to meet the requirement of clamping the valve leaflet.

It should be noted that the hook 14 can be opened relative to the support arm 131 under the traction of an external force, so that the valve is inserted between the hook 14 and the support arm 131.

In this embodiment, two leaflets of the valve can be clamped by the 2 support arms 131 and the corresponding hooks 14, respectively, and the leaflets are prevented from easily escaping from between the clamping arms 132 and the spacer 11 during the catching process of the clip device 10.

Specifically, when 2 gripping arms 132 capture the leaflet with respect to the spacer 11, the gripping arms 132 and the spacer 11 need to be in an incomplete gripping state so that the leaflet enters between the gripping arms 132 and the spacer 11, and then the leaflet can be gripped by gripping arms 132 with respect to the spacer 11. However, in the capturing process, the leaflet is shaken at will by the impact of blood flow, and easily escapes from the gap between the clamp arm 132 and the spacer 11 in the incompletely clamped state, eventually resulting in the failure of capturing.

In this embodiment, before the 2 clipping arms 132 are completely clipped to the spacer 11, since the leaflets are clipped between the hooks 14 and the support arms 131, the leaflets are not easy to escape from the clipping device 10 during the process of clipping the 2 clipping arms 132 to each other, and finally the leaflets are stably clipped and fixed after the 2 support arms 131 are folded to the spacer 11.

In some embodiments, the hook 14 may be connected to the supporting arm 131, or connected to the distal end connecting portion 11b of the spacer 11, as long as the hook 14 corresponds to the corresponding supporting arm 131, and can be clamped with the supporting arm 131 when not being subjected to an external force, and can be opened relative to the supporting arm 131 when being pulled by the external force. As shown in fig. 1 and 3, the delivery device 20 includes a delivery catheter 21, a pusher assembly 22, and a release assembly 23.

Wherein, conveying conduit 21 is a multi-lumen conduit, and in particular, conveying conduit 21 comprises a pushing lumen 211 and at least 2 side lumens 212. In this embodiment, the number of the side cavities 212 is 2, and in other embodiments, the number of the side cavities 212 may be 3 or more.

The pushing component 22 penetrates through the pushing cavity 211 and is detachably connected with the clamp 10, and the pushing component 22 is used for controlling the opening and closing of the clamp 10. The 2 side cavities 212 are distributed on two sides of the pushing cavity 211, the releasing assemblies 23 are 2 groups, and the 2 groups of releasing assemblies 23 respectively penetrate through the 2 side cavities 212 and can axially move relative to the conveying catheter 21, and are used for controlling the corresponding clasps 14 to open or close relative to the supporting arms 131 to clamp the corresponding valve leaflets.

It should be noted that, the hooks 14 on the corresponding side can be independently operated by the 2 groups of release elements 23, so that when one group of release elements 23 is used to operate the corresponding hooks 14 to capture one of the leaflets of the valve, the condition of the other side leaflet does not need to be considered, and after the clamping operation of the side leaflet is completed, the capture of the other leaflet of the valve is completed by operating the other group of release elements 23. Under the structure, the two groups of release assemblies 23 are not interfered with each other in operation, the operation is more flexible and convenient, and the valve capture efficiency is improved.

The distal end 21a of the delivery catheter 21 is in the form of an adjustable bent tube to facilitate adjustment of the orientation of the clip 10 connected to the pusher assembly 22 to allow accurate movement of the clip 10 to the location where the valve needs to be repaired.

In some embodiments, pusher lumen 211 extends along the longitudinal central axis of delivery catheter 21 or extends parallel to the longitudinal central axis of delivery catheter 21, 2 side lumens 212 are arranged in mirror image, and the longitudinal central axis of delivery catheter 21 is located on a mirror plane between the 2 side lumens 212. The layout mode is simple, the structure of the mirror image arrangement of the conveying conduit 21 is matched with the symmetrical structure of the clamping device 10, and the operability is better. In other embodiments, the 2 side cavities 212 may not be distributed on the two sides of the pushing cavity 211 in a mirror image manner, as long as the releasing elements 23 located in the side cavities 212 are adapted to operate the corresponding clasps 14 to open and close.

As shown in connection with fig. 4, the pushing assembly 22 includes a pushing rod 221 and a pushing tube 222. The push rod 221 is movably inserted through the push tube 222, a distal end 221a of the push rod 221 is connected with the fixing base 12, and a distal end 222a of the push tube 222 is connected with the spacer 11. So that the spacer 11 and the fixed seat 12 move relatively by manipulating the push rod 221 and the push tube 222 to move relatively in the axial direction, and then the opening state of the 2 clamping arms 132 of the clamp 10 is adjusted. Due to the relative movement of the push rod 221 and the push tube 222, the spacer 11 and the fixing base 12 can be linked to move relatively, so that when the relative position of the push rod 221 and the push tube 222 is locked, the relative position of the spacer 11 and the fixing base 12 is also locked, and the state of the 2 clamping arms 132 and the 2 supporting arms 131 is maintained.

In some embodiments, the delivery device 20 comprises a locking structure (not shown), which is used to lock the relative positions of the push rod 221 and the push tube 222, so that the push rod 221 and the push tube 222 cannot move relatively, thereby achieving the purpose of locking the opened state of the 2 clamping arms 132.

As shown in fig. 1, the spacer 11 has a through hole formed along its axial direction, and the through hole penetrates the proximal connecting portion 11a and the distal connecting portion 11 b. Referring to fig. 1 and 4, the distal end 221a of the push rod 221 passes through the through hole and is detachably connected to the fixing base 12, and the distal end 222a of the push tube 222 is detachably connected to the proximal connecting portion 11 a. So that after the clamp 10 clamps the two leaflets of the valve, the pusher assembly 22 can be disconnected from the clamp 10 to facilitate subsequent withdrawal of the pusher assembly 22.

In some embodiments, the distal end 221a of the pushing rod 221 is threadedly coupled to the fixed base 12, so as to be quickly coupled to the fixed base 12 or decoupled from the fixed base 12 by manipulating the pushing rod 221 to rotate around the axial direction relative to the fixed base 12.

In some embodiments, the distal end 222a of the push tube 222 is threadedly coupled to the proximal connection portion 11a, so that the push tube 222 can be quickly coupled to the proximal connection portion 11a or decoupled from the proximal connection portion 11a by rotating the push tube 222 about the axial direction relative to the fixed base 12.

As shown in fig. 1 and 5, the releasing assembly 23 includes an inner tube 231, a first pulling member 232, a second pulling member 233 and a mandrel 234.

Wherein, the inner tube 231 has a lumen 231a, the lumen 231a extends through the distal end 2311 and the proximal end 2312 of the inner tube 231 along the axial direction of the inner tube 231, so that the structural members such as the second traction member 233 and the mandrel 234 can enter the lumen 231a from the proximal end 2312 of the inner tube 231, and the requirement that the first traction member 232 passes out from the distal end 2311 along the lumen 231a can be met, so as to adapt to the corresponding manipulation requirement.

First pull member 232 includes a first loop 232a and second pull member 233 is at least partially disposed within lumen 231a, including a second loop 233 a. Mandrel 234 is axially movable within lumen 231 a. The first collar 232a and/or the second collar 233a can be sleeved on the core shaft 234, in other words, the core shaft 234 is inserted into at least one of the first collar 232a and the second collar 233 a.

In this embodiment, the position of the first and

second collars

232a, 233a relative to the mandrel 234 is configured to: first traction element 232 is axially constrained to second traction element 233 at the axial end of mandrel 234 such that when second traction element 233 moves with inner tube 231 towards the proximal end 2312 of inner tube 231, first traction element 232 is able to move towards the proximal end 2312 of inner tube 231, and when mandrel 234 is withdrawn along lumen 231a, second traction element 233 releases the axial traction on first traction element 232.

In this embodiment, the first and

second collars

232a and 233a are engaged with the mandrel 234, so that the first and second pulling

members

232 and 233 can conveniently limit or release the pulling of the first pulling member 232 by the second pulling member 233 along the axial direction of the mandrel 234. Thus, during the operation of releasing element 23 to open clasp 14 relative to support arm 131, releasing element 23 moves along lateral lumen 212 of delivery catheter 21 to allow first pulling member 232 to pull clasp 14 open relative to support arm 131. After the valve leaflets are clamped by the hooks 14 and the support arms 131, the spindle 234 is only required to be pulled away to release the axial limit of the second traction element 233 and the first traction element 232, so that the operation is very simple and convenient, and the operation time is shortened. After the second traction member 233 and the first traction member 232 relieve the axial limitation, traction force cannot be generated on the hook 14 through the first traction member 232, so that the hook 14 cannot be unfolded relative to the support arm 131 to cause the slippage of valve leaflets during subsequent withdrawal, the valve shedding risk is effectively reduced, and the operation success rate is improved.

In some embodiments, one end of the hook 14 is connected to the supporting arm 131 or the spacer 11, and the other end is connected to the first pulling member 232, and under the pulling of the first pulling member 232, the hook 14 and the supporting arm 131 are mutually opened. Since the hook 14 and the support arm 131 are clamped together when the hook 14 is not subjected to an external force, the force for pulling the hook 14 to open relative to the support arm 131 by the first pulling member 232 is greater than the clamping restoring force of the hook 14 relative to the support arm 131. Specifically, under the traction of the first traction element 232 on the hook 14, the hook 14 can be opened relative to the support arm 131, so that the leaflet is inserted between the hook 14 and the support arm 131, and thus the hook 14 and the support arm 131 can meet the clamping requirement of the leaflet. After the leaflet is inserted between the hook 14 and the support arm 131, the first pulling member 232 may release the pulling of the hook 14, so that the hook 14 moves back toward the support arm 131 to complete the clamping of the leaflet.

Since the mandrel 234 is more rigid than the delivery catheter, when the delivery catheter 21 is bent, at least a portion of the mandrel 234 may be bent at the bent portion of the delivery catheter 21 (e.g., at least a portion of the mandrel 234 is bent into a bow shape), if the release element 23 does not include the inner tube 231, the bent portion of the mandrel 234 may abut against the inner wall of the lateral cavity 212, and when at least a portion of the first collar 232a is located at the proximal side of the bent portion of the mandrel 234, even if the axial restraining effect of the first collar 232a by the second collar 233a is released, the first collar 232a cannot slide through the position where the mandrel 234 abuts against the inner wall of the lateral cavity 212, so that the clasp 14 cannot be operated by the second pulling member 233.

In some embodiments, the portions of the first collar 232a, the second collar 233a, and the mandrel 234 that radially overlap one another are interference fit within the lumen 231 a. With this structure, the first collar 232a, the second collar 233a and the mandrel 234 can be wrapped by the external inner tube 231 as a whole, so that when the opening and closing of the hook 14 need to be operated, only the inner tube 231 needs to be pushed and pulled axially, so that the inner tube 231 moves axially along the side lumen 212 of the delivery catheter 21.

In this embodiment, the control loop 232a, the traction loop 233a, and the mandrel 234 are wrapped by the inner tube 231 to form a whole, so that even if the conveying conduit 21 is bent, in the bent state, the control wire 232 can release the traction force acting on the hook 14 only by operating the inner tube 231 to move towards the distal end, and further the hook 14 can be clamped with the support arm 131 under its own acting force, thereby ensuring that the hook 14 can be operated to open or clamp relative to the support arm 131, and improving the reliability of the leaflet clamping operation.

It should be noted that, since the release assembly 23 is formed as a whole when the first pulling member 232, the second pulling member 233 and the mandrel 234 are interference-fitted into the lumen 231a of the inner tube 231, that is, when the inner tube 231 moves axially along the side cavity 212 of the delivery catheter 21, the first pulling member 232, the second pulling member 233 and the mandrel 234 in the inner tube 231 move along with the inner tube 231, when the pulling force acting on the hook 14 needs to be released to clamp the hook 14 toward the support arm 131, the inner tube 231 can be manipulated to move toward the hook 14, so that the clamping of the hook 14 and the support arm 131 to the valve leaflet is more reliable.

A first pulling member 232 may be attached to an end of the clasp 14 remote from the spacer to facilitate opening of the clasp 14 relative to the support arm 131 by pulling on the clasp 14 by the first pulling member 232. The connection between the first pulling member 232 and the hook 14 is not limited herein, as long as the first pulling member 232 can pull the hook 14 to open relative to the supporting arm 131, and when the pulling of the hook 14 is released, the hook 14 can move back towards the supporting arm 131.

It should also be noted that in other embodiments, release member 23 may not include inner tube 231, and in such cases, it may be implanted using other delivery paths with relatively low curvature (e.g., apical path) to avoid bending delivery catheter 21 and mandrel 234, and thus avoid at least a portion of mandrel 234 against the inner wall of lateral lumen 212, thereby operating first retractor 233 relatively closer to or farther away from clasp 14 to enable clasp 14 to open or close relative to support arm 131.

In some embodiments, as shown in fig. 2, a thread through hole 141 is formed in the hook 14, and the first pulling member 232 passes through the thread through hole 141 and is fixed to the hook 14 by knotting or winding. In other embodiments, first traction member 232 and clasp 14 are adhered together by glue.

It should be noted that there are many possibilities for the arrangement of the first and second pulling

members

232, 233 and the mandrel 234. The first traction element 232 and the second traction element 233 are axially limited under the action of the mandrel 234, and when the mandrel 234 is pulled away, the axial limitation between the first traction element 232 and the second traction element 233 is released.

For example, in some embodiments, as shown in connection with fig. 5, the first loop 232a is disposed around the mandrel 234 and exits at least one distal pulling section 232c toward the distal end 234a of the mandrel 234. The second loop 233a is disposed around the distal pulling portion 232c and extends toward the proximal end 234b of the core shaft 234. With this structure, while the first collar 232a is radially restrained by the mandrel 234, the second collar 233a has an axial traction effect on the distal traction section 232c, so that the first collar 232a cannot be drawn away from the second collar 233a, i.e. the first traction element 232 and the second traction element 233 are kept axially restrained by the mandrel 234.

With continued reference to fig. 5, in this embodiment, after the mandrel 234 is withdrawn from the first loop 232a, the first loop 232a is not constrained by the mandrel 234, and at this point, the first loop 232a can be withdrawn from the second loop 233a, such that the first and second pulling

members

232, 233 are no longer axially constrained relative to one another, and as the release assembly 23 is withdrawn along the lateral lumen 212 of the delivery catheter 21, no traction is exerted on the clip 14, thereby reducing the risk of the clip 14 opening relative to the support arms 131 and causing the leaflets to slip.

In other embodiments, as shown in connection with fig. 6, the second loop 233a is disposed around the core shaft 234 and has at least one proximal pulling portion 233c leading out towards the proximal end 234b of the core shaft 234. The first loop 232a is sleeved on the proximal traction segment 233c and extends toward the distal end 234a of the core shaft 234. With this configuration, while the second collar 233a is radially retained by the core shaft 234, the first collar 232a has an axial traction effect on the proximal traction section 233c, so that the second collar 233a cannot be withdrawn from the first collar 232a, i.e. the first traction element 232 and the second traction element 233 are axially retained by the core shaft 234. Accordingly, when the mandrel 234 is withdrawn from the second collar 233a, the second collar 233a is no longer constrained by the mandrel 234, thereby allowing the second collar 233a to be withdrawn from the first collar 232a to release the constraint between the first traction element 232 and the second traction element 233.

In other embodiments, as shown in fig. 7, the first pulling member 232 is located outside the second loop 233a, i.e., the first pulling member 232 is located outside the contour area of the second loop 233 a; the second pulling member 233 is located outside the first collar 232a, that is, the second pulling member 233 is located outside the outline area of the first collar 232a, in this arrangement, the first pulling member 232 and the second pulling member 233 are not nested with each other, that is, a chain-like ring structure is not formed, so that the first pulling member 232 and the second pulling member 233 can only achieve the limit to each other along the axial direction of the mandrel 234 under the constraint of the mandrel 234, and after the mandrel 234 is pulled out from the inner tube 231, the first pulling member 232 and the second pulling member 233 do not generate a constraint force by themselves, and then the first pulling member 232 and the second pulling member 233 can be separated.

With continued reference to fig. 7, in this embodiment, the first collar 232a and the second collar 233a are both disposed around the core shaft 234. Wherein, the first collar 232a is sleeved on the core shaft 234 and the first pulling member 232 extends towards the distal end of the core shaft 234, the second collar 233a is sleeved on the core shaft 234 and the second pulling member 233 extends towards the proximal end of the core shaft 234, the portion of the first collar 232a surrounding the core shaft 234 is closer to the proximal end 234b of the core shaft 234 than the portion of the second collar 233a surrounding the core shaft 234, so that the first collar 232a and the second collar 233a are limited to each other along the axial direction of the core shaft 234, and then the first pulling member 232 and the second pulling member 233 are limited together axially, after the core shaft 234 is withdrawn, the first collar 232a and the second collar 233a can move in the inner tube 231 and limit the first pulling member 232 and the second pulling member 233 along the axial direction of the core shaft 234.

It should be noted that there are many possibilities for the formation of the first and

second collars

232a, 233 a.

For example, in some embodiments, the first collar 232a is formed by connecting the first pulling member 232 end to end, i.e., the first pulling member 232 is configured as a first collar 232a and then is generally annular. Accordingly, in some embodiments, the second loop 233a is formed by connecting the ends of the second pulling member 233.

In other embodiments, first traction element 232 includes other structures in addition to forming part of first collar 232 a.

For example, as shown in connection with FIG. 8, the first pulling member 232 further comprises a first linear portion 232b, the first linear portion 232b is connected to the first collar 232a and extends from the distal end 2311 of the inner tube 231. Thus, the first collar 232a may be connected to the hook 14 by the first linear portion 232 b.

In some embodiments, and with continued reference to fig. 8, second traction element 233 further includes a second linear portion 233b, and second linear portion 233b is coupled to second loop 233 a. With this arrangement, the second collar 233a is configured to meet the quick release requirements of the first collar 232a relative to the mandrel 234. Meanwhile, after the mandrel 234 releases the first and second pulling

members

232 and 233, the second pulling member 233 may be withdrawn from the inner tube 231 using the second linear portion 233b connected to the second collar 233 a.

It should be noted that the first traction member 232 may be an absorbable surgical suture or similar functioning material, and thus may be absorbed even if left in the body with the clip device 10.

In some embodiments, the material of the inner tube 231 is PE (polyethylene), PI (Polyimide resin), or TPU (Thermoplastic polyurethane elastomer rubber). The mandrel 234 may be stainless steel or nickel titanium or any other metal or polymeric material capable of achieving a similar.

In a valve repair procedure using the valve clamping system 100, as shown in fig. 9, the delivery catheter 21 is passed through the femoral vein and the inferior vena cava to the right atrium 001, and then the interatrial septum 005 is punctured and the tip of the delivery catheter 21 reaches the left atrium 002. The distal end 21a of the delivery catheter 21 is adjusted to be at a neutral position over the mitral valve 004. As shown in fig. 10, after the position of the delivery catheter 21 is adjusted, the clip 10 is output from the distal end 21a of the delivery catheter 21 along the delivery catheter 21, so that the clip 10 is pushed to the mitral valve 004 position. As shown in fig. 11, after the clip 10 is pushed into place, the grasping arms 132 of the clip 10 are opened by manipulating the pushing assembly 22 within the delivery catheter 21. In this way, release member 23 can be manipulated to move proximally relative to delivery catheter 21 to cause clasp 14 to spread apart relative to support arms 131 using traction of first traction elements 232 of release member 23 to capture leaflets of mitral valve 004. As shown in fig. 12, after the hook 14 and the support arm 131 clamp the leaflets, the pusher 22 is manipulated to make the binder 10 clamp the two leaflets of the mitral valve 004 together, and the mandrel 234 is axially withdrawn proximally from the inner tube 231, so as to complete the release of the hook 14, that is, the release element 23 no longer pulls the hook 14. At this time, after the pushing assembly 22 is separated from the fixing seat 12 and the spacer of the clamping device 10, the delivery catheter 21 can be withdrawn, and the operation is completed.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A release assembly, comprising:

a first pulling member comprising a first collar;

a second pulling member at least partially positioned within the lumen, comprising a second collar; and

a mandrel axially movable within the lumen, at least one of the first and second collars being sleeved on the mandrel, the position of the first and second collars relative to the mandrel being configured to: the first traction member is located at the second traction member on an axial upper limit of the mandrel so that the first traction member can move towards the proximal end of the inner tube when the second traction member moves with the inner tube towards the proximal end of the inner tube, and the second traction member releases the axial traction on the first traction member when the mandrel is withdrawn along the lumen.

2. The release assembly of claim 1, wherein portions of the first collar, the second collar, and the mandrel that radially overlap one another are interference fit within the lumen.

3. The release assembly of claim 1, wherein the first collar is disposed on the mandrel and extends distally from the distal pulling portion of the mandrel, and the second collar is disposed on the distally pulling portion and extends proximally from the mandrel;

or the second sleeve ring is sleeved on the mandrel and leads out a proximal traction section towards the proximal end of the mandrel, and the first sleeve ring is sleeved on the proximal traction section and extends towards the distal end of the mandrel;

or, the first traction member is located outside the second collar, the second traction member is located outside the first collar, the first collar is sleeved on the mandrel and the first traction member extends towards the distal end of the mandrel, the second collar is sleeved on the mandrel and the second traction member extends towards the proximal end of the mandrel, wherein the portion of the first collar surrounding the mandrel is closer to the proximal end of the mandrel than the portion of the second collar surrounding the mandrel.

4. The release assembly of any of claims 1-3, wherein the first collar is formed by joining the first pulling member end to end; and/or the second lantern ring is formed by connecting the head end and the tail end of the second traction piece.

5. The release assembly of any of claims 1-3, wherein the first pulling member further comprises a first wire connected to the first collar; and/or the second traction element further comprises a second linear part which is connected with the second sleeve ring.

6. A delivery device, comprising a delivery catheter, a pushing component and the releasing component according to any one of claims 1 to 5, wherein the delivery catheter is a multi-lumen catheter and comprises a pushing cavity and at least 2 side cavities, the at least 2 side cavities are distributed on two sides of the pushing cavity, the releasing components are 2 groups, the 2 groups of releasing components are respectively arranged in the at least 2 side cavities in a penetrating manner and can axially move relative to the delivery catheter, the pushing component is arranged in the pushing cavity in a penetrating manner and is detachably connected with a clamping device, and the pushing component is used for controlling the opening and closing of the clamping device.

7. The delivery device of claim 6, wherein the pushing lumen extends along a longitudinal central axis of the delivery catheter or extends parallel to the longitudinal central axis of the delivery catheter, the number of the side lumens is 2, 2 of the side lumens are arranged in a mirror image, and the longitudinal central axis of the delivery catheter is located on a mirror surface between the 2 side lumens.

8. A valve clamping system comprising the delivery device of claim 6 or 7.

9. The valve clamping system of claim 8, comprising a clamp, wherein the clamp comprises a spacer, a holder, and a clamping assembly, wherein the clamping assembly comprises at least 2 support arms and at least 2 clamping arms, the at least 2 support arms are respectively rotatably connected to two sides of the spacer, one end of each of the at least 2 clamping arms is connected to the holder, and the other end of each of the at least 2 clamping arms is rotatably connected to an end of the at least 2 support arms away from the spacer; when the at least 2 clamping arms are not affected by external force, the at least 2 clamping arms are clamped together towards the direction close to the spacing piece, and the at least 2 supporting arms are folded between the at least 2 clamping arms; when the distance piece and the fixed seat are far away from each other along the axial direction, the distance piece is linked with the at least 2 supporting arms to rotate relative to the at least 2 clamping arms respectively, so that the at least 2 supporting arms drive the at least 2 supporting arms to be mutually expanded towards the direction far away from the distance piece.

10. The valve clamping system of claim 9, wherein the spacer comprises a proximal connecting portion and a distal connecting portion opposite to each other, the spacer has a through hole formed along an axial direction thereof, the through hole penetrates through the proximal connecting portion and the distal connecting portion, the at least 2 support arms are rotatably connected to the distal connecting portion, the pushing assembly comprises a pushing rod and a pushing tube, the pushing rod movably penetrates through the pushing tube, a distal end of the pushing rod penetrates through the through hole and is detachably connected to the fixing base, a distal end of the pushing tube is detachably connected to the proximal connecting portion, and when the pushing rod and the pushing tube move relatively in the axial direction, the spacer approaches to or leaves away from the fixing base along the pushing rod.