Valve clipping system, delivery device and release assembly thereof

Abstract

The present invention provides a valve clamping system, a delivery device, and a release assembly thereof, wherein the release assembly comprises an inner tube, a first traction member, a second traction member, and a core shaft, wherein the first traction member and the second traction member respectively comprise a first collar and a second collar, wherein the core shaft is capable of axially moving within the lumen of the inner tube and passing through at least one of the first collar and the second collar, wherein the first traction member is located at the second traction member at the axial upper limit of the core shaft, so that when the second traction member moves toward the proximal end of the inner tube along with the inner tube, the first traction member can move toward the proximal end of the inner tube, and when the core shaft is withdrawn from the first collar or the second collar along the lumen, the second traction member releases the axial traction on the first traction member. The present invention provides a valve clamping system, a delivery device, and a release assembly thereof, wherein the release assembly is capable of opening and closing the clasp to facilitate the capture of the valve, and the clasp can be released by withdrawing the core shaft, effectively avoiding the traction on the clasp during the subsequent withdrawal process that may cause the valve to slip.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve clamping system, a delivery device and a release component thereof. Background Art

[0002] Mitral valve disease is a common condition among the elderly. It includes two common types: mitral regurgitation and mitral stenosis, with mitral regurgitation being the most common. Statistics show that the incidence of mitral regurgitation in people over 75 years old is as high as 10%. Mild mitral regurgitation generally has no impact on normal life, while moderate to severe or severe mitral regurgitation requires interventional treatment. Traditional surgical treatment involves thoracotomy, in which the heart is opened with the support of an extracorporeal circulation machine to repair or replace the valve, but high-risk patients cannot tolerate this. The rise of interventional therapy in recent years has brought hope to high-risk patients with mitral regurgitation. Interventional therapy generally involves delivering instruments to the affected area via a catheter to repair or replace the valve.

[0003] At present, most transcatheter mitral valve replacement products are in the clinical research stage, and transcatheter mitral valve repair products usually use a clamping device to clamp the two leaflets (anterior leaflet and posterior leaflet) of the mitral valve. In order to better clamp the leaflets, before the clamping device clamps the leaflets, the leaflets are generally clamped and fixed by hooks so that the leaflets are in a stable state, and then the clamping device is operated so that the leaflets are clamped and fixed by the clamping device, thereby reducing the valve opening area and achieving the purpose of treating reflux. Summary of the Invention

[0004] Based on this, the present invention provides a release component that can operate and release the hook, as well as a delivery device and a valve clamping system including the release component.

[0005] In one aspect, the present invention provides a release assembly comprising:

[0006] an inner tube having a lumen running through the distal end and the proximal end of the inner tube;

[0007] A first pulling member including a first collar;

[0008] a second pulling member, at least partially located within the lumen, comprising a second loop; and

[0009] The core shaft is capable of axially moving in the tubular cavity, and at least one of the first ring and the second ring is sleeved on the core shaft. The positions of the first ring and the second ring relative to the core shaft are configured as follows: the first traction member is located at the second traction member at the axial upper limit of the core shaft, so that when the second traction member moves toward the proximal end of the inner tube along with the inner tube, the first traction member can move toward the proximal end of the inner tube, and when the core shaft is withdrawn along the tubular cavity, the second traction member releases the axial traction of the first traction member.

[0010] On the other hand, the present invention provides a delivery device, including a delivery catheter, a pushing assembly and a release assembly as described above. The delivery catheter is a multi-cavity catheter, including a pushing cavity and at least two side cavities, and the at least two side cavities are distributed on both sides of the pushing cavity. The release assembly is divided into two groups, and the two groups of release assemblies are respectively arranged in at least two side cavities and can move axially relative to the delivery catheter. The pushing assembly is arranged in the pushing cavity and is detachably connected to the clamp. The pushing assembly is used to control the opening and closing of the clamp.

[0011] In yet another aspect, the present invention provides a valve clamping system comprising the above-mentioned delivery device.

[0012] The valve clamping system, delivery device and release assembly provided by the present invention adopt a first ring and a second ring to cooperate with the core shaft, so that the first traction member and the second traction member can conveniently realize the axial limitation along the core shaft or release the traction of the second traction member on the first traction member, so that the first traction member can be connected with the clasp to realize the operation of the second traction member on the clasp through the first traction member. When the clasp needs to be released, it is only necessary to pull out the core shaft to release the axial limitation of the second traction member and the first traction member. This release assembly is simple to operate, shortens the operation time, and effectively reduces the risk of valve falling off, thereby improving the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, without paying any creative work, they can also obtain drawings of other embodiments based on these drawings.

[0014] Figure 1 Schematic diagram of the structure of a valve clipping system according to one embodiment;

[0015] Figure 2 for Figure 1 A schematic diagram of the structure of the clipper in the valve clipping system is shown, showing the state in which the support arm is extending the clamping arm, i.e., the first pulling member pulling the corresponding hook to open relative to the support arm;

[0016] Figure 3 Schematic diagram of the structure of a delivery catheter of a delivery device in a valve clipping system according to one embodiment;

[0017] Figure 4 Schematic diagram of the structure of a pushing assembly of a delivery device in a valve clipping system according to one embodiment;

[0018] Figure 5Schematic diagram of the structure of a release assembly of a delivery device in a valve clipping system according to one embodiment;

[0019] Figure 6 Schematic diagram of the structure of a release assembly of a delivery device in a valve clipping system according to another embodiment;

[0020] Figure 7 This is a schematic structural diagram of a release assembly of a delivery device in a valve clipping system according to yet another embodiment;

[0021] Figure 8 This is a schematic structural diagram of a release assembly of a delivery device in a valve clipping system according to yet another embodiment;

[0022] Figure 9 A schematic diagram of the puncture path of the delivery catheter of the delivery device during a valve repair operation using a valve clipping system;

[0023] Figure 10 Schematic diagram of a valve clipper being pushed along a delivery catheter to the valve position during a valve repair operation using a valve clipping system;

[0024] Figure 11 A schematic diagram of a valve repair operation using a valve clipping system, in which the clipper is in an open state, and a first pulling member pulls the corresponding hook relative to the support arm to open and capture the valve leaflets;

[0025] Figure 12 Schematic diagram of the state after the clipper completes the valve leaflet clipping operation and the delivery device is withdrawn. DETAILED DESCRIPTION

[0026] To facilitate understanding of the present invention, the present invention will be described more fully below with reference to the accompanying drawings. The accompanying drawings illustrate preferred embodiments of the present invention. However, the present invention may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and comprehensive understanding of the present disclosure.

[0027] It should be noted that the terms "distal" and "proximal" are commonly used in the medical device field. "Distal" refers to the end away from the operator during operation, while "proximal" refers to the end closer to the operator during operation. Axial refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; radial refers to the direction perpendicular to the axial direction.

[0028] Combine Figure 1As shown, the present invention provides a valve clipping system 100, comprising a clipper 10 and a delivery device 20. The delivery device 20 is detachably connected to the clipper 10, allowing the clipper 10 to be delivered to a desired position and then released. It should be noted that the delivery device 20 includes a structure for manipulating the opening and closing of the clipper 10, thereby controlling the clipper 10 to clamp the two leaflets of the valve and complete the functional restoration of the valve.

[0029] Combine Figure 2 As shown, the clamp 10 includes a spacer 11, a fixed base 12, and a clamping assembly 13. The clamping assembly 13 comprises two support arms 131 and two clamping arms 132. The two support arms 131 are rotatably connected to either side of the spacer 11. One end of each clamping arm 132 is connected to the fixed base 12, and the other end is rotatably connected to the end of the two support arms 131 away from the spacer 11. With this connection, relative movement between the fixed base 12 and the spacer 11 causes the two support arms 131 and the two clamping arms 132 to move relative to each other, thereby changing the state of the two clamping arms 132.

[0030] Specifically, when the two clamping arms 132 are in a natural state (i.e., when not subject to external forces), they clamp together toward the septum 11. In other words, the two clamping arms 132 have a tendency to clamp together, and thus, when not subject to external forces, they can rely on their own clamping force to gather together, thereby providing a power source for clamping the two leaflets of the valve. This allows the clipper 10 to maintain its clamping effect on the two leaflets of the valve after the delivery device 20 is withdrawn.

[0031] In some embodiments, the two clamping arms 132 and the fixing seat 12 are an integral structure. For example, after cutting out two axially extending clamping arms 132 from a nickel-titanium tube, the clamping arms 132 are deflected and shaped in a direction away from the axis of the nickel-titanium tube, thereby forming two clamping arms 132 with an inward clamping tendency.

[0032] When the two clamping arms 132 are clamped together, the two support arms 131 are folded between the two clamping arms 132. Specifically, the two support arms 131 rotate relative to the two clamping arms 132 under the clamping force provided by the two clamping arms 132, thereby being folded between the two clamping arms 132. Therefore, when the two support arms 131 rotate relative to the two clamping arms 132 and expand, the two support arms 131 can overcome the clamping force of the two clamping arms 132 and drive the two clamping arms 132 to expand. After the clipper 10 is adjusted to a suitable position relative to the valve, the two support arms 131 are folded relative to the two clamping arms 132 by manipulating the relative movement of the fixing seat 12 and the septum 11. Under the clamping action of the two clamping arms 132, the leaflets located between the clamping arms 132 and the septum 11 are clamped, completing the leaflet capture.

[0033] In some embodiments, when the septum 11 and the holder 12 move axially away from each other, the septum 11 coordinates the two support arms 131 to rotate relative to the two clamping arms 132, causing the two support arms 131 to force the two support arms 131 to expand toward each other, away from the septum 11. Accordingly, when the septum 11 and the holder 12 move axially toward each other, the two clamping arms 132, under their own clamping force, clamp toward the septum 11, while simultaneously coordinating the two support arms 131, to which they are rotatably connected, to collapse and ultimately abut against the septum 11. Thus, the two clamping arms 132 can be opened and closed by manipulating the axial relative position of the septum 11 and the holder 12, thereby capturing the leaflets at an appropriate position. If the capture position is not ideal, the two clamping arms 132 can be reopened by adjusting the axial relative position of the septum 11 and the holder 12, and the leaflets can be clamped again after adjusting to the appropriate position.

[0034] In some embodiments, the spacer 11 includes a relative proximal connection portion 11a and a distal connection portion 11b, and the two support arms 131 are rotatably connected to the distal connection portion 11b, so that when the two clamping arms 132 drive the two support arms 131 to fold toward the spacer 11, the two support arms 131 can eventually be clamped on both sides of the spacer 11, and then, under the restriction of the spacer 11, the two support arms 131 will not continue to move toward each other, and eventually reach a stable state, so as to stably clamp the two leaflets of the valve.

[0035] In some embodiments, the clip 10 includes hooks 14 corresponding to the two support arms 131. When the hooks 14 are not subjected to external forces, the hooks 14 and the support arms 131 clamp together to meet the need of clamping the leaflets.

[0036] It should be particularly pointed out that the clasp 14 can be opened relative to the support arm 131 under the traction of an external force, so that the valve can be placed between the clasp 14 and the support arm 131.

[0037] In this embodiment, the two support arms 131 and the corresponding hooks 14 can be used to clamp the two leaflets of the valve respectively, preventing the leaflets from escaping from between the clamping arms 132 and the spacer 11 during the capture process of the clamp 10.

[0038] Specifically, when the two clamping arms 132 are relative to the septum 11 to capture the leaflets, the clamping arms 132 and the septum 11 need to be in a partially closed state to allow the leaflets to enter between the clamping arms 132 and the septum 11. The leaflets can then be clamped by the clamping arms 132 being relative to the septum 11. However, during the capture process, the leaflets may vibrate randomly under the impact of blood flow and easily escape from the gap between the partially closed clamping arms 132 and the septum 11, ultimately resulting in capture failure.

[0039] In this embodiment, before the two clamping arms 132 are completely clamped relative to the spacer 11, the leaflets are clamped between the hooks 14 and the support arms 131, so that the leaflets are not easy to escape from the clamp 10 during the process of the two clamping arms 132 clamping each other. Finally, the leaflets are stably clamped and fixed after the two support arms 131 are folded relative to the spacer 11.

[0040] In some embodiments, the clasp 14 can be connected to the support arm 131 or to the distal end connection portion 11b of the spacer 11, as long as the clasp 14 corresponds to the corresponding support arm 131, can be clamped together with the support arm 131 when not subjected to external force, and can be opened relative to the support arm 131 under the traction of external force. Figure 1 and Figure 3 As shown, the delivery device 20 includes a delivery catheter 21 , a pushing component 22 and a releasing component 23 .

[0041] The delivery catheter 21 is a multi-lumen catheter, specifically comprising a push cavity 211 and at least two side cavities 212. In this embodiment, the number of side cavities 212 is two, and in other embodiments, the number of side cavities 212 may be three or more.

[0042] The push assembly 22 is disposed within the push chamber 211 and is removably connected to the clipper 10. It controls the opening and closing of the clipper 10. Two side chambers 212 are located on either side of the push chamber 211. Two sets of release assemblies 23 are disposed within the two side chambers 212, respectively. These release assemblies 23 are capable of axial movement relative to the delivery catheter 21 and are used to control the opening or closing of corresponding clasps 14 relative to the support arms 131, thereby clamping the corresponding leaflets.

[0043] It should be noted that the two sets of release assemblies 23 can independently operate the corresponding clasps 14. Therefore, when one set of release assemblies 23 is used to operate the corresponding clasp 14 to capture one leaflet of the valve, there is no need to consider the condition of the leaflet on the other side. After completing the clamping operation of the leaflet on that side, the other set of release assemblies 23 can be used to complete the capture of the other leaflet of the valve. With this structure, the two sets of release assemblies 23 do not interfere with each other's operation, which is more flexible and improves the efficiency of valve capture.

[0044] The distal end 21a of the delivery catheter 21 is an adjustable curved tube body, so as to adjust the direction of the clipper 10 connected to the pushing assembly 22, so that the clipper 10 can be accurately moved to the position where the valve needs to be repaired.

[0045] In some embodiments, the push chamber 211 extends along or parallel to the longitudinal center axis of the delivery catheter 21, and the two side chambers 212 are arranged in a mirror image, with the longitudinal center axis of the delivery catheter 21 located on the mirror plane between the two side chambers 212. This layout is relatively simple, and the mirror image arrangement of the delivery catheter 21 aligns with the symmetrical structure of the clip 10, improving operability. In other embodiments, the two side chambers 212 may not be mirror images on either side of the push chamber 211, as long as they can accommodate the release assembly 23 located in the side chamber 212 to manipulate the corresponding clasp 14 for opening and closing.

[0046] Combine Figure 4 As shown, the push assembly 22 includes a push rod 221 and a push tube 222. The push rod 221 is movably disposed within the push tube 222. The distal end 221a of the push rod 221 is connected to the fixed seat 12, while the distal end 222a of the push tube 222 is connected to the spacer 11. By manipulating the push rod 221 and the push tube 222 for relative axial movement, the spacer 11 and the fixed seat 12 are moved relative to each other, thereby adjusting the open position of the two clamping arms 132 of the clamp 10. The relative movement of the push rod 221 and the push tube 222 can also cause relative movement between the spacer 11 and the fixed seat 12. Therefore, 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 fixed seat 12 is also locked, thereby maintaining the state of the two clamping arms 132 and the two support arms 131.

[0047] In some embodiments, the conveying device 20 includes a locking structure (not shown), which uses the locking structure 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 relative to each other, thereby achieving the purpose of locking the two clamping arms 132 in the open state.

[0048] Combine Figure 1 As shown, the spacer 11 is provided with a through hole along its axial direction, and the through hole passes through the proximal connecting portion 11a and the distal connecting portion 11b. Figure 1 and Figure 4 The distal end 221a of the push rod 221 passes through the perforation and is detachably connected to the fixing seat 12. The distal end 222a of the push tube 222 is detachably connected to the proximal connecting portion 11a. After the clipper 10 has completed clamping the two leaflets of the valve, the connection between the push assembly 22 and the clipper 10 can be released, facilitating subsequent removal of the push assembly 22.

[0049] In some embodiments, the distal end 221a of the push rod 221 is threadedly connected to the fixing base 12 so that the push rod 221 can be quickly connected to or disconnected from the fixing base 12 by rotating the push rod 221 axially relative to the fixing base 12.

[0050] In some embodiments, the distal end 222a of the push tube 222 is threadedly connected to the proximal connection portion 11a, so that the push tube 222 can be quickly connected to or disconnected from the proximal connection portion 11a by controlling the push tube 222 to rotate axially relative to the fixed seat 12.

[0051] Combine Figure 1 and Figure 5 As shown, the release assembly 23 includes an inner tube 231 , a first pulling member 232 , a second pulling member 233 and a core shaft 234 .

[0052] Among them, the inner tube 231 has a lumen 231a, and the lumen 231a passes through the distal end 2311 and the proximal end 2312 of the inner tube 231 parallel to the axial direction of the inner tube 231, so that the second traction member 233, the core shaft 234 and other structural parts can enter the lumen 231a from the proximal end 2312 of the inner tube 231, and can meet the needs of the first traction member 232 to pass through the distal end 2311 along the lumen 231a to meet the corresponding control needs.

[0053] First pulling member 232 includes a first collar 232a. Second pulling member 233 is at least partially located within lumen 231a and includes a second collar 233a. Mandrel 234 is capable of axial movement within lumen 231a. First collar 232a and / or second collar 233a can be sleeved onto mandrel 234. In other words, mandrel 234 is inserted through at least one of first collar 232a and second collar 233a.

[0054] In this embodiment, the positions of the first ring 232a and the second ring 233a relative to the core shaft 234 are configured as follows: the first traction member 232 is located at the second traction member 233 at the axial upper limit of the core shaft 234, so that when the second traction member 233 moves along the inner tube 231 toward the proximal end 2312 of the inner tube 231, the first traction member 232 can move toward the proximal end 2312 of the inner tube 231, and when the core shaft 234 is pulled out along the tubular cavity 231a, the second traction member 233 releases the axial traction on the first traction member 232.

[0055] In this embodiment, the first and second collars 232a, 233a cooperate with the mandrel 234, allowing the first and second pull members 232, 233 to conveniently limit the axial position of the mandrel 234 or release the second pull member 233 from pulling the first pull member 232. Thus, when the release assembly 23 is used to manipulate the clasp 14 to open relative to the support arm 131, the release assembly 23 as a whole moves along the lateral lumen 212 of the delivery catheter 21, allowing the first pull member 232 to pull the clasp 14 open relative to the support arm 131. After the clasp 14 and the support arm 131 clamp the leaflet, the mandrel 234 need only be withdrawn to release the axial position of the second pull member 233 and the first pull member 232. This operation is extremely simple and reduces operation time. After the second traction member 233 and the first traction member 232 are released from the axial limit, no traction force will be generated on the hook 14 through the first traction member 232, so that the hook 14 will not be caused to expand relative to the support arm 131 during subsequent withdrawal, causing the leaflet to slip off, effectively reducing the risk of valve falling off and improving the success rate of the operation.

[0056] In some embodiments, one end of the clasp 14 is connected to the support arm 131 or the spacer 11, and the other end is connected to the first pulling member 232. Under the traction of the first pulling member 232, the clasp 14 and the support arm 131 are opened relative to each other. Because the clasp 14 and the support arm 131 are clamped together when not subject to external force, the force exerted by the first pulling member 232 to pull the clasp 14 open relative to the support arm 131 is greater than the clamping restoring force of the clasp 14 relative to the support arm 131. Specifically, under the traction of the first pulling member 232 on the clasp 14, the clasp 14 can open relative to the support arm 131, so that the leaflet is placed between the clasp 14 and the support arm 131, thereby enabling the clasp 14 and the support arm 131 to meet the needs of clamping the leaflet. After the leaflet is placed between the clasp 14 and the support arm 131 , the traction of the first traction member 232 on the clasp 14 can be released, so that the clasp 14 moves back toward the support arm 131 to complete the clamping of the leaflet.

[0057] Since the rigidity of the core shaft 234 is greater than that of the delivery catheter, when the delivery catheter 21 is bent, at least a portion of the core shaft 234 will also bend at the bent portion of the delivery catheter 21 (for example, at least a portion of the core shaft 234 is bent into a bow shape). If the release component 23 does not include the inner tube 231, the bent portion of the core shaft 234 may abut against the inner wall of the side cavity 212. When at least a portion of the first ring 232a is located on the proximal side of the bent portion of the core shaft 234, even if the axial limiting effect of the second ring 233a on the first ring 232a is released, the first ring 232a cannot slide through the portion where the core shaft 234 abuts against the inner wall of the side cavity 212, thereby making it impossible to control the hook 14 through the second traction member 233.

[0058] In some embodiments, the radially overlapping portions of the first collar 232a, the second collar 233a, and the core shaft 234 are interference-fitted within the lumen 231a. This structure allows the first collar 232a, the second collar 233a, and the core shaft 234 to be wrapped integrally by the outer inner tube 231. Therefore, to open or close the clasp 14, one only needs to push or pull the inner tube 231 axially, causing it to move axially along the side lumen 212 of the delivery catheter 21.

[0059] In this embodiment, the control collar 232a, the traction collar 233a and the core shaft 234 are wrapped in the inner tube 231 to form a whole. Even if the delivery catheter 21 is bent, in the bent state, it is only necessary to operate the inner tube 231 to move toward the distal end, and the control wire 232 can release the traction force acting on the hook 14, so that the hook 14 can be clamped with the support arm 131 under its own force, thereby ensuring that the hook 14 can be operated to open or clamp relative to the support arm 131, thereby improving the reliability of the leaflet clamping operation.

[0060] It should be pointed out in particular that, since the first traction member 232, the second traction member 233 and the core shaft 234 are interference fit in the lumen 231a of the inner tube 231, the release assembly 23 forms a whole, that is, when the inner tube 231 moves axially along the side cavity 212 of the delivery catheter 21, the first traction member 232, the second traction member 233 and the core shaft 234 in the inner tube 231 all move with the inner tube 231. Therefore, when it is necessary to release the traction force acting on the clasp 14 and make the clasp 14 clamp toward the support arm 131, the inner tube 231 can be manipulated to move toward the clasp 14, so that the clasp 14 and the support arm 131 can clamp the leaflet more reliably.

[0061] The first pulling member 232 can be connected to the end of the clasp 14 away from the isolation member, so that the clasp 14 can be pulled by the first pulling member 232 to open relative to the support arm 131. The connection method between the first pulling member 232 and the clasp 14 is not limited herein, as long as the first pulling member 232 can pull the clasp 14 to open relative to the support arm 131 and the clasp 14 can return to the support arm 131 when the clasp 14 is released.

[0062] It should also be pointed out that in other embodiments, the release assembly 23 may not include the inner tube 231. In this case, other delivery paths with relatively smaller curvature (such as the apical path) can be used for implantation to avoid bending of the delivery catheter 21 and the core shaft 234, thereby avoiding at least a portion of the core shaft 234 from abutting against the inner wall of the side cavity 212, thereby operating the first traction member 233 to be relatively close to or away from the hook 14, so that the hook 14 can be opened or clamped relative to the support arm 131.

[0063] In some embodiments, combined Figure 2 As shown, the hook 14 is provided with a wire hole 141, and the first pulling member 232 passes through the wire hole 141 and is fixed to the hook 14 by knotting, winding, etc. In other embodiments, the first pulling member 232 and the hook 14 are bonded together by glue.

[0064] It should be noted that there are various possible configurations of the first and second pulling members 232, 233 and the core shaft 234. As long as the first and second pulling members 232, 233 can be axially restrained under the action of the core shaft 234, and the axial restraint between the first and second pulling members 232, 233 is released when the core shaft 234 is withdrawn, it is sufficient.

[0065] For example, in some embodiments, in combination Figure 5 As shown, the first collar 232a is sleeved on the core shaft 234 and extends at least one distal pulling segment 232c toward the distal end 234a of the core shaft 234. The second collar 233a is sleeved on the distal pulling segment 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 core shaft 234, the second collar 233a exerts an axial pulling effect on the distal pulling segment 232c, thereby preventing the first collar 232a from being removed from the second collar 233a. In other words, the first and second pulling members 232 and 233 remain axially restrained by the core shaft 234.

[0066] Continue reading Figure 5 As shown, in this embodiment, after the core shaft 234 is pulled out from the first ring 232a, the first ring 232a is no longer restricted by the core shaft 234. At this time, the first ring 232a can be pulled out from the second ring 233a. Therefore, the first traction member 232 and the second traction member 233 are no longer axially limited to each other. When the release component 23 is withdrawn along the side cavity 212 of the delivery catheter 21, no traction is generated on the hook 14, thereby reducing the risk of the hook 14 opening relative to the support arm 131 and causing the leaflet to slip.

[0067] In other embodiments, combined Figure 6As shown, the second collar 233a is sleeved on the core shaft 234 and extends at least one proximal traction segment 233c toward the proximal end 234b of the core shaft 234. The first collar 232a is sleeved on the proximal traction segment 233c and extends toward the distal end 234a of the core shaft 234. With this structure, the second collar 233a is radially restrained by the core shaft 234 while the first collar 232a exerts an axial traction effect on the proximal traction segment 233c, thereby preventing the second collar 233a from being removed from the first collar 232a. In other words, the first and second traction members 232 and 233 remain axially restrained by the core shaft 234. Accordingly, when the core shaft 234 is pulled out from the second ring 233a, the second ring 233a is no longer constrained by the core shaft 234, so that the second ring 233a can be pulled out from the first ring 232a to release the constraint between the first traction member 232 and the second traction member 233.

[0068] Combine Figure 7 As shown, in other embodiments, the first traction member 232 is located outside the second ring 233a, that is, the first traction member 232 is located outside the contour area of the second ring 233a; the second traction member 233 is located outside the first ring 232a, that is, the second traction member 233 is located outside the contour area of the first ring 232a. Under this arrangement, the first traction member 232 and the second traction member 233 are not nested with each other, that is, a chain ring structure will not be formed, so that the first traction member 232 and the second traction member 233 can only be limited to each other along the axial direction of the core shaft 234 under the constraint of the core shaft 234. After the core shaft 234 is pulled out of the inner tube 231, the first traction member 232 and the second traction member 233 themselves will not generate a restraining force, and then the two can be separated.

[0069] Continue reading Figure 7 As shown, in this embodiment, the first ring 232a and the second ring 233a are both sleeved on the core shaft 234. Among them, the first ring 232a is sleeved on the core shaft 234 and the first traction member 232 extends toward the distal end of the core shaft 234, the second ring 233a is sleeved on the core shaft 234 and the second traction member 233 extends toward the proximal end of the core shaft 234, and the part of the first ring 232a surrounding the core shaft 234 is closer to the proximal end 234b of the core shaft 234 than the part of the second ring 233a surrounding the core shaft 234, so that the first ring 232a and the second ring 233a are limited to each other in the axial direction of the core shaft 234, and then the first traction member 232 and the second traction member 233 are axially limited together. After the core shaft 234 is pulled out, the first ring 232a and the second ring 233a can move in the inner tube 231 and realize the axial limitation of the first traction member 232 and the second traction member 233 along the core shaft 234.

[0070] It should be noted that there are many possible formation structures of the first ring 232a and the second ring 233a.

[0071] For example, in some embodiments, the first loop 232a is formed by connecting the head and tail ends of the first pulling member 232. That is, after the first pulling member 232 is configured as the first loop 232a, the entirety is annular. Correspondingly, in some embodiments, the second loop 233a is formed by connecting the head and tail ends of the second pulling member 233.

[0072] In other embodiments, the first pulling member 232 includes other structures in addition to the portion forming the first loop 232 a .

[0073] For example, combined with Figure 8 As shown, the first pulling member 232 further includes a first linear portion 232b, which is connected to the first collar 232a and extends from the distal end 2311 of the inner tube 231. In this way, the first collar 232a is connected to the hook 14 using the first linear portion 232b.

[0074] In some embodiments, see Figure 8 As shown, the second pulling member 233 also includes a second linear portion 233b, which is connected to the second collar 233a. This structure allows the second collar 233a to be quickly released from the first collar 232a relative to the core shaft 234. Furthermore, after the core shaft 234 releases the first and second pulling members 232 and 233, the second linear portion 233b connected to the second collar 233a can be used to remove the second pulling member 233 from the inner tube 231.

[0075] It should be noted that the first traction member 232 can be absorbable surgical sutures or materials with similar functions, so that it can be absorbed even if it remains in the body along with the clip 10.

[0076] In some embodiments, the inner tube 231 is made of PE (polyethylene), PI (Polyimide), or TPU (Thermoplastic polyurethanes). The core shaft 234 can be made of stainless steel, nickel titanium, or any other metal or polymer material capable of achieving similar properties.

[0077] Combine Figure 9As shown, when the valve clipping system 100 is used for valve repair, the delivery catheter 21 is passed through the femoral vein and the inferior vena cava to the right atrium 001, and then the atrial 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 located in the middle position above the mitral valve 004. Figure 10 As shown, 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 position of the mitral valve 004. Figure 11 As shown, after the clip 10 is pushed to the appropriate position, the pushing assembly 22 in the delivery catheter 21 is manipulated to open the clamping arms 132 of the clip 10. In this way, the release assembly 23 can be manipulated to move proximally relative to the delivery catheter 21, so that the first pulling member 232 of the release assembly 23 can pull the clasp 14, causing the clasp 14 to open relative to the support arm 131 to capture the leaflets of the mitral valve 004. Figure 12 As shown, after the clasp 14 and support arm 131 clamp the leaflets, the clipper 10 is manipulated to clamp the two leaflets of the mitral valve 004 together by manipulating the pusher assembly 22. The core shaft 234 is then axially withdrawn proximally from the inner tube 231, releasing the clasp 14. The release assembly 23 no longer pulls the clasp 14. At this point, the pusher assembly 22 is separated from the fixing base 12 and the spacer of the clipper 10, and the delivery catheter 21 can be withdrawn, completing the procedure.

[0078] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0079] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A release assembly, characterized in that: include: an inner tube having a lumen running through the distal end and the proximal end of the inner tube; A first pulling member including a first collar; a second pulling member, at least partially located within the lumen, comprising a second loop; and The core shaft is capable of axially moving in the tubular cavity, at least one of the first ring and the second ring is sleeved on the core shaft, the radially overlapping parts of the first ring, the second ring and the core shaft are interference fit in the tubular cavity, and the positions of the first ring and the second ring relative to the core shaft are configured as follows: the first traction member is located at the second traction member at the axial upper limit of the core shaft, so that when the second traction member moves with the inner tube toward the proximal end of the inner tube, the first traction member can move toward the proximal end of the inner tube, and when the core shaft is withdrawn along the tubular cavity, the second traction member releases the axial traction on the first traction member, so that the second traction member can separate from the first traction member toward the proximal end of the inner tube.

2. The release assembly according to claim 1, wherein: The first collar is sleeved on the core shaft and leads a distal traction section toward the distal end of the core shaft. The second collar is sleeved on the distal traction section and extends toward the proximal end of the core shaft.

3. The release assembly according to claim 1, wherein: Alternatively, the second collar is sleeved on the core shaft and extends a proximal traction section toward the proximal end of the core shaft, and the first collar is sleeved on the proximal traction section and extends toward the distal end of the core shaft; Or, the first traction member is located outside the second ring, the second traction member is located outside the first ring, the first ring is sleeved on the core shaft and the first traction member extends toward the distal end of the core shaft, the second ring is sleeved on the core shaft and the second traction member extends toward the proximal end of the core shaft, wherein the portion of the first ring surrounding the core shaft is closer to the proximal end of the core shaft than the portion of the second ring surrounding the core shaft.

4. The release assembly according to any one of claims 1 to 3, characterized in that: The first loop is formed by connecting the head and tail ends of the first pulling member; and / or the second loop is formed by connecting the head and tail ends of the second pulling member.

5. The release assembly according to any one of claims 1 to 3, characterized in that: The first pulling member further includes a first linear portion connected to the first collar; and / or the second pulling member further includes a second linear portion connected to the second collar.

6. A conveying device, characterized in that: It includes a delivery catheter, a pushing assembly and a release assembly as described in any one of claims 1 to 5, the delivery catheter is a multi-cavity catheter, including a pushing cavity and at least two side cavities, the at least two side cavities are distributed on both sides of the pushing cavity, the release assembly is divided into two groups, the two groups of release assemblies are respectively provided in the at least two side cavities, and can move axially relative to the delivery catheter, the pushing assembly is provided in the pushing cavity, and is detachably connected to the clamp, and the pushing assembly is used to control the opening and closing of the clamp.

7. The conveying device according to claim 6, characterized in that The push cavity extends along the longitudinal center axis of the delivery catheter or extends parallel to the longitudinal center axis of the delivery catheter. The number of the side cavities is 2, and the 2 side cavities are mirror-set. The longitudinal center axis of the delivery catheter is located on the mirror surface between the 2 side cavities.

8. A valve clipping system, characterized in that: Comprising the delivery device according to claim 6 or 7.

9. The valve clipping system according to claim 8, characterized in that: The invention provides a clamping device, wherein the clamping device includes a spacer, a fixing seat and a clamping assembly, wherein the clamping assembly includes at least two support arms and at least two clamping arms, the at least two support arms are respectively rotatably connected to both sides of the spacer, one end of the at least two clamping arms is connected to the fixing seat, and the other end is respectively rotatably connected to the end of the at least two support arms away from the spacer; when the at least two clamping arms are not subjected to external force, the at least two clamping arms clamp each other in a direction close to the spacer, and the at least two support arms are folded between the at least two clamping arms; when the spacer and the fixing seat move away from each other in the axial direction, the spacer links the at least two support arms to rotate relative to the at least two clamping arms, so that the at least two support arms drive the at least two support arms to open each other in a direction away from the spacer.

10. The valve clipping system according to claim 9, characterized in that: The spacer includes a relative proximal connection part and a distal connection part, and the spacer is provided with a through hole along its axial direction, and the through hole passes through the proximal connection part and the distal connection part, and the at least two support arms are rotatably connected to the distal connection part. The pushing assembly includes a push rod and a push tube, and the push rod is movably provided in the push tube. The distal end of the push rod passes through the through hole and is detachably connected to the fixed seat, and the distal end of the push tube is detachably connected to the proximal connection part. When the push rod and the push tube move relative to each other along the axial direction, the spacer approaches or moves away from the fixed seat along the push rod.

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