Valve clamping system, delivery device and release assembly thereof

Abstract

The valve clamping system, the delivery device and the release assembly thereof, the connecting body, the at least two clamping pieces extending towards the distal end, the at least two clamping pieces being arranged along the circumference of the connecting body, and at least one of the at least two clamping pieces being elastic; the constraint structure comprising a constraint ring, the constraint ring being detachably sleeved on the connecting body, and the constraint ring being capable of moving axially relative to the connecting body; when the constraint ring moves from the proximal end to the distal end and towards the direction away from the proximal end of the clamping piece, the at least two clamping pieces are clamped to each other under the radial constraint of the constraint ring to clamp the implanted instrument; when the constraint ring moves from the distal end to the proximal end and towards the direction close to the proximal end of the clamping piece, the constraint ring releases the radial constraint on the at least two clamping pieces, and the at least two clamping pieces are opened to each other to release the implanted instrument. The release assembly provided by the application can release the implanted instrument.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a valve clamping system, delivery device and release assembly thereof. Background Technology

[0002] Mitral valve disease is a common condition among the elderly, including two common types: mitral regurgitation and mitral stenosis, with mitral regurgitation being the most prevalent. Statistics show that the incidence of mitral regurgitation in people over 75 years of age is as high as 10%. Mild mitral regurgitation generally does not affect daily life, while moderate to severe mitral regurgitation requires intervention. Traditional surgical treatment involves open-heart surgery, where the heart is opened under cardiopulmonary bypass to repair or replace the valves. However, high-risk patients cannot tolerate this procedure. In recent years, interventional therapy has emerged, offering hope to high-risk patients with mitral regurgitation. Interventional therapy typically involves delivering instruments to the affected area via catheter to repair or replace the valve.

[0003] Currently, most transcatheter mitral valve replacement products are in the clinical research stage, while transcatheter mitral valve repair products usually use a clamping device to clamp the two leaflets (anterior and posterior leaflets) of the mitral valve, thereby reducing the valve opening area and achieving the purpose of treating regurgitation.

[0004] Therefore, there is a need for a conveyor that can be detachably connected to the clamping device, so that the conveyor can transport the clamping device to the target part and release the clamping device. Summary of the Invention

[0005] Based on this, the present invention provides a release assembly for releasing clamping devices.

[0006] The present invention provides a release assembly for controllably releasing an implanted device, the release assembly comprising:

[0007] A connector having at least two clips extending distally, the at least two clips being circumferentially spaced along the connector, and at least one of the at least two clips being elastic;

[0008] A constraint structure includes a constraint ring, which is detachably fitted onto the connecting body and is axially movable relative to the connecting body.

[0009] When the constraint ring moves from the proximal end to the distal end and toward the proximal end away from the clips, the at least two clips clamp each other under the radial restraint of the constraint ring, thereby clamping the implanted device. When the constraint ring moves from the distal end to the proximal end and toward the proximal end of the clips, the constraint ring releases the radial restraint on the at least two clips, and the at least two clips open up to each other, thereby releasing the implanted device.

[0010] The valve clamping system, delivery device, and release assembly provided by the present invention, wherein when the release assembly is in use, when the restraint ring moves from the proximal end to the distal end and toward the proximal end away from the clips, at least two clips clamp each other under the radial restraint of the restraint ring to clamp the implanted device; when the restraint ring moves from the distal end to the proximal end and toward the proximal end closer to the clips, the restraint ring releases the radial restraint on the at least two clips, and the at least two clips open to each other to release the implanted device. Attached Figure Description

[0011] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other embodiments can be obtained from these drawings without creative effort.

[0012] Figure 1 This is a schematic diagram of the valve clamping system according to one embodiment;

[0013] Figure 2 This is a schematic diagram of the valve clamping system in one embodiment, showing the clamping device separated from the delivery device.

[0014] Figure 3 This is a schematic diagram of the valve clamping system in another embodiment, showing the clamping device separated from the delivery device.

[0015] Figure 4 This is a schematic diagram of a valve clamping system according to one embodiment, showing the structure of the support arm opening the clamping arm. The diagram schematically shows the hook opening relative to the support arm under the traction of the traction wire.

[0016] Figure 5 for Figure 4 In the valve clamping system shown, the figure schematically illustrates the closing of the hook relative to the support arm when the traction wire releases its traction on the hook.

[0017] Figure 6 A schematic diagram of the delivery catheter of the delivery device in a valve clamping system according to one embodiment;

[0018] Figure 7 A schematic diagram showing the separation state of the connector and the connection portion of the implanted device in the release assembly of a valve clamping system according to one embodiment.

[0019] Figure 8 for Figure 7 A schematic diagram showing the mating state of the connector and the connection part of the implantable device;

[0020] Figure 9 A schematic diagram of the structure of the connecting body of the release device according to one embodiment;

[0021] Figure 10 This is a schematic diagram of the release assembly of a valve clamping system according to one embodiment. The diagram schematically shows the release of the movable end of the constraint structure from the radial restraint of the clamp and the connecting part.

[0022] Figure 11 This is a schematic diagram of the release assembly of a valve clamping system according to one embodiment. The diagram schematically shows the constraint structure radially limiting the clamp to the connection portion.

[0023] Figure 12 A schematic diagram of the constraint structure of a release component according to one embodiment;

[0024] Figure 13 for Figure 12 Another schematic diagram of the constraint structure of the release component is shown;

[0025] Figure 14 Structural intent of the release component for another implementation;

[0026] Figure 15 for Figure 14 The diagram shows the structure when the release component is connected to the connecting part;

[0027] Figure 16 A schematic diagram of the sheath puncture path during valve repair using a valve clamping system;

[0028] Figure 17 A schematic diagram showing the clamp being pushed to the valve position by the delivery catheter during valve repair using a valve clamping system.

[0029] Figure 18 A schematic diagram illustrating the process of using a valve clamping system to capture the valve leaflets after the clamp is opened during valve repair.

[0030] Figure 19 In the process of repairing a valve using a valve clamping system, the traction wire releases the hook, and the hook clamps the valve leaflet with the support arm. (Diagram showing the valve leaflet clamped by the hook and support arm.)

[0031] Figure 20 A schematic diagram showing the state of the valve leaflets being clamped by the clamping device.

[0032] Figure 21 This is a schematic diagram showing the state of the conveying device before it separates from the clamping device.

[0033] Figure 22 This is a schematic diagram showing the state after the traction wire has been removed from the hook;

[0034] Figure 23 This is a schematic diagram showing the state after the mandrel has been removed from the clamp.

[0035] Figure 24 A schematic diagram showing the state of the connecting body when the movable end of the control constraint structure is released and the clamping piece of the connector is released;

[0036] Figure 25 This is a schematic diagram showing the release device disconnected from the connecting part. Detailed Implementation

[0037] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of the invention.

[0038] It should be noted that the terms "distal" and "proximal" are used as directional terms, where "distal" refers to the end furthest from the operator during operation, and "proximal" refers to the end closest to the operator during operation. Similarly, the terms "distal" and "proximal" are used as directional terms, where "distal" refers to the end furthest from the operator during operation, and "proximal" refers to the end closest to the operator during operation. Axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0039] Combination Figure 1 As shown, the present invention provides a valve clamping system 100, including a clamping device 10 and a delivery device 20. The delivery device 20 is detachably connected to the clamping device 10, thereby delivering the clamping device 10 to a suitable position and then releasing it.

[0040] It should be noted that the conveying device 20 includes a structure that controls the clamping device 10 to open or close, so as to control the clamping device 10 to hold the two leaflets of the valve and complete the functional repair of the valve.

[0041] In other embodiments, the delivery device 20 may be other implantable devices such as vascular stents or occluders, other than the clamp 10, for manipulating and releasing. The types of implantable devices will not be listed here, as long as the delivery device 20 can meet the needs of manipulating and releasing the corresponding implantable device.

[0042] For ease of understanding, the following explanation will take the implantation device controlled by the delivery device 20 as an example, with the clamp 10 as the example.

[0043] Combination Figure 2 As shown, the clamp 10 includes a spacer 11, a fixing base 12, and a clamping assembly 13.

[0044] The spacer 11 can be a deformable cage made of woven elastic metal wire. The surface of the spacer 11 can be covered with a polymer film, such as PET cloth or PTFE film. In this embodiment, after the clamping device 10 clamps the leaflets, the spacer 11 can play a sealing and filling role. At the same time, due to its own deformability, it can reduce the clamping stress of the clamping device 10 on the leaflets.

[0045] The clamping assembly 13 includes two support arms 131 and two clamping arms 132. The two support arms 131 are rotatably connected to both sides of the spacer 11, and one end of each clamping arm 132 is connected to the fixed base 12, while the other end is rotatably connected to the end of each support arm 131 away from the spacer 11. With this connection, when the fixed base 12 and the spacer 11 move relative to each other, the two support arms 131 and the two clamping arms 132 will move relative to each other, thereby changing the state of the two clamping arms 132.

[0046] by Figure 2 and Figure 3 Taking the valve clamping system shown as an example, when the two clamping arms 132 are not subjected to external force, the two clamping arms 132 clamp each other towards the spacer 11. That is to say, the two clamping arms 132 have a tendency to clamp together, so that when no external force is applied, they can rely on their own clamping force to converge, thereby providing a power source for clamping the two leaflets of the valve, so that after the delivery device 20 is removed, the clamper 10 can still maintain the clamping effect on the two leaflets of the valve.

[0047] In some embodiments, the two clamping arms 132 and the fixing base 12 are integrally formed. For example, two axially extending arms are cut from a nickel-titanium tube and then shaped to form two clamping arms 132 with an inward clamping tendency.

[0048] When the two clamping arms 132 clamp together, the two supporting arms 131 fold between the two clamping arms 132. Specifically, the two supporting arms 131 rotate relative to the two clamping arms 132 under the clamping force provided by the two clamping arms 132, thereby folding between the two clamping arms 132. Thus, combined with Figure 4 As shown, when the two support arms 131 rotate and open relative to the two clamping arms 132, the two support arms 131 can overcome the clamping force of the two clamping arms 132 and drive the two clamping arms 132 to open.

[0049] After the clamping device 10 is adjusted to the appropriate position relative to the valve, the conveying device 20 is operated to make the fixed seat 12 and the spacer 11 move relative to each other, so that the two support arms 131 are folded up relative to the two clamping arms 132, so as to gradually release the support of the support arms 131 on the clamping arms 132. Then the clamping arms 132 clamp each other to clamp the leaflet located between the clamping arms 132 and the spacer 11, thus completing the leaflet capture.

[0050] In some embodiments, when the spacer 11 and the fixed seat 12 move away from each other axially, the spacer 11, in conjunction with the two support arms 131, rotates relative to the two clamping arms 132, causing the two support arms 131 to open away from the spacer 11. Correspondingly, when the spacer 11 and the fixed seat 12 move closer to each other axially, the two clamping arms 132 clamp towards the spacer 11 under their own clamping force, while simultaneously retracting and finally abutting against the spacer 11, in conjunction with the two support arms 131 rotatably connected to them. Thus, by manipulating the axial relative position of the spacer 11 and the fixed seat 12, the opening and closing operations of the two clamping arms 132 can be achieved, thereby capturing the leaflets at a suitable position. When the capture position is not ideal, by adjusting the axial relative position of the spacer 11 and the fixed seat 12, the two clamping arms 132 can be reopened, and the leaflets can be clamped again after being adjusted to a suitable position.

[0051] In some embodiments, the spacer 11 includes opposing proximal connecting portions 11a and distal connecting portions 11b, with two support arms 131 rotatably connected to the distal connecting portions 11b. This allows the two clamping arms 132 to fold the two support arms 131 toward the spacer 11, ultimately clamping the two support arms 131 on both sides of the spacer 11. Consequently, under the constraint of the spacer 11, the two support arms 131 will not continue to move toward each other, eventually reaching a stable state to stably clamp the two leaflets of the valve.

[0052] In some implementations, combined Figure 5 As shown, the clamping device 10 includes hooks 14 corresponding to the two support arms 131. When the hooks 14 are not subjected to external force, they clamp together with the support arms 131, thereby adapting to the need to clamp the leaflets.

[0053] It should be particularly pointed out that, in combination Figure 4 As shown, the hook 14 can open relative to the support arm 131 under the pull of an external force, so that the valve can be placed between the hook 14 and the support arm 131.

[0054] In this embodiment, the two support arms 131 and the corresponding hooks 14 can respectively clamp the two leaflets of the valve, preventing the leaflets from easily escaping between the clamping arms 132 and the spacer 11 during the capture process of the clamping device 10.

[0055] Specifically, when the two gripping arms 132 grasp the petals relative to the spacer 11, the gripping arms 132 and the spacer 11 need to be in a partially closed state so that the petals can enter between the gripping arms 132 and the spacer 11. The petals can only be grasped by subsequently closing the gripping arms 132 relative to the spacer 11. However, during the grasping process, the petals vibrate randomly under the impact of blood flow, making them prone to escape through the gap between the partially closed gripping arms 132 and the spacer 11, ultimately leading to capture failure.

[0056] In this embodiment, before the two clamping arms 132 are fully clamped relative to the spacer 11, the petal is clamped between the hook 14 and the support arm 131, so that the petal is not easy to escape from the clamper 10 during the process of the two clamping arms 132 clamping each other. Finally, after the two support arms 131 are folded relative to the spacer 11, the petal is stably clamped and fixed.

[0057] In some embodiments, the hook 14 may be connected to the support arm 131 or to the distal end connection portion 11b of the spacer 11, as long as the hook 14 corresponds to the corresponding support arm 131 and can clamp with the support arm 131 when not subjected to external force, and open relative to the support arm 131 under the traction of external force.

[0058] Combination Figure 1 and Figure 2 As shown, the delivery device 20 includes a delivery catheter 21 and a release assembly 22. The release assembly 22 is used for the controllable release of implantable devices such as clamps 10, vascular stents, or occluders. The delivery catheter 21 serves as the mounting carrier for the release assembly 22, enabling it to push the release assembly 22, along with the implantable device connected to it, to the appropriate position. During the release operation of the implantable device by manipulating the release assembly 22, the delivery catheter 21 also provides stable support for the release assembly 22.

[0059] Combination Figure 6 As shown, the delivery conduit 21 is a multi-lumen tube, meaning that the delivery conduit 21 has more than one lumen, so that different lumens can be used to adapt to the setting needs of different operating components.

[0060] For example, combining Figure 4 and Figure 5 As shown, the hook 14 is opened or closed with the support arm 131 by manipulating the traction wire 10a.

[0061] Specifically, one end of the hook 14, away from the spacer 11, is connected to the traction wire 10a. This allows the hook 14 to open relative to the support arm when the traction wire 10a pulls it proximally. Correspondingly, as the traction wire 10a is gradually released, the hook 14 returns to its clamped state relative to the support arm under its own elasticity. In this embodiment, the delivery conduit 21 has a through hole 212 through which the traction wire 10a passes and can move axially relative to the delivery conduit 21 along the through hole 212 to meet the traction requirements of the traction wire 10a on the hook 14.

[0062] It should be noted that in some embodiments, the delivery conduit 21 has a guide hole (not shown in the figure) that is not connected to the through hole 212. The guide hole is used to accommodate the installation of the traction wire 10a, that is, the traction wire 10a passes through the guide hole and can move axially relative to the delivery conduit 21 along the guide hole. In this case, the through hole 212 of the delivery conduit 21 can be used for other purposes. The purpose of the through hole 212 of the delivery conduit 21 will be explained in an appropriate place below, and will not be repeated here.

[0063] See here. Figure 1 and Figure 2 As shown, the release component 22 includes a connector 222 and a constraint structure 223.

[0064] The connector 222 has at least one clip 222a extending distally. The clip 222a has a mating portion 222b, which is detachably connected to the connector head 111 of the implantation device in the radial direction. The connector head 111 has a connecting portion 111a. Through the mating of the mating portion 222b and the connecting portion 111a, the connecting portion 111a is axially confined within the connector 222. In the illustrated embodiment, there are two clips 222a. In other embodiments, there may be multiple clips 222a.

[0065] Among them, such as Figure 2 As shown, taking the clamp 10 as an example, the connecting part 111a serves as the part of the clamp 10 that mates with the connecting body 222. The connecting part 111a is located at the proximal end of the clamp 10. In this embodiment, the number of connecting parts 111a is the same as the number of mating parts 222b, and they correspond one-to-one. In other embodiments, the number of connecting parts 111a is different from the number of mating parts 222b; it is sufficient for one connecting part 111a to be connected to one mating part 222b.

[0066] The constraint structure 223 includes a constraint ring 223a, which is detachably sleeved on the connector 222. The constraint ring 223a is axially movable relative to the connector 222. When the constraint ring 223a moves to the point where at least a portion of it radially overlaps with at least a portion of the connecting portion 111a, and at least a portion of the constraint ring 223a radially overlaps with at least a portion of the mating portion 222b of the clip 222a, the constraint ring 223a is used to limit the mating portion 222b to the connecting portion 111a of the implanted device along the radial direction of the constraint structure 223. That is, the constraint ring 223a restricts the clip 222a from separating from the connecting portion 111a along the radial direction of the constraint structure 223, thereby keeping the mating portion 222b of the clip 222a in contact with the connecting portion 111a. Thus, the connecting portion 111a is axially limited to the connector 222.

[0067] It should be noted that radial overlap of two structural components refers to the establishment of a projection plane for projecting the structural components radially, where the regions of the two structural components on this projection plane overlap. For example, when at least a portion of the constraint ring 223a and at least a portion of the mating portion 222b of the clip 222a are radially overlapped, and a common projection plane for the constraint ring 223a and the mating portion 222b is taken through the axis of the connecting body 222, then at least a portion of the projection area of ​​the constraint ring 223a on this projection plane falls into the projection area of ​​the mating portion 222b on this projection plane.

[0068] When the constraint ring 223a moves to the point where at least a portion of it radially overlaps with at least a portion of the connecting portion 111a, and at least a portion of the constraint ring 223a radially overlaps with at least a portion of the mating portion 222b of the clamp 222a, at least a portion of the connecting portion 111a and the mating portion 222b overlap in the length direction of the clamp 222a, thereby causing the connecting portion 111a to be located at the upper limit of the connecting body 222 in the length direction of the clamp 222a, that is, the connecting portion 111a is axially limited to the connecting body 222.

[0069] When either the connecting part 111a or the mating part 222b is a hole or a groove, the overlap here means that it overlaps with the hole wall or the groove wall.

[0070] It should be noted that the constraint ring 223a can be an open-loop structure; for example, the central angle corresponding to the constraint ring 223a is greater than 180°. In other embodiments, the constraint ring 223a can be a closed ring component.

[0071] In some implementations, combined Figures 11 to 15As shown, the proximal end 223b of the constraint structure 223 is fixedly connected to the connector 222. The constraint structure 223 includes a retractable structure 223c connected to the constraint ring 223a. The portion of the constraint structure 223 fixedly connected to the connector 222 is located on the proximal side of the retractable structure 223c, and the constraint ring 223a is located on the distal side of the retractable structure. This utilizes the retractable nature of the retractable structure 223c to allow the constraint ring 223a to tend to move towards the distal end of the clip 222a relative to the portion of the constraint structure 223 fixedly connected to the connector 222. In this embodiment, the length of the constraint structure 223 is less than that of the connector 222, which helps reduce the stiffness of the release assembly and facilitates the release assembly's passage through curved transport paths.

[0072] In some embodiments, the release assembly 22 includes an operating member 224 connected to a restraint ring 223a and used to move the restraint ring 223a toward the proximal end of the clip 222a, so that the restraint ring 223a can be misaligned with the mating part 222b in the length direction of the clip 222a, thereby releasing the radial restraint of the restraint ring 223a on the mating part 222b and the connecting part 111a, thereby allowing the mating part 222b and the connecting part 111a to separate, thereby achieving the effect of the connector 222 releasing the connecting part 111a of the implanted device.

[0073] When the release assembly 22 is connected to the implantation device, the telescopic structure 223c is in an axially contracted state. This allows the telescopic structure 223c to provide good axial deformation when the implantation device is pushed, so that the constraint ring 222a is kept between the mating part 222b and the connecting part 111a and provides a good constraint effect, preventing the implantation device from falling off the release assembly 22 abnormally and causing inaccurate release position.

[0074] Taking the clamp 10 as an example, since the telescopic structure 223c has axial telescopic performance, the restraint ring 223a can be maintained at the position corresponding to the mating part 222b of the clamp 222a, so as to ensure the connection stability between the mating part 222b and the connecting part 111a of the clamp 10. In this way, even if the delivery catheter 21 needs to be bent during the delivery of the clamp 10, the connecting part 111a of the clamp 10 will not fall off from the connecting body 222, so as to ensure the accuracy of the release position of the clamp 10.

[0075] It should be noted that the proximal end of the connector 222 is connected to the delivery conduit 21 so that when the clamp 222a of the connector 222 is connected to the connection part 111a of the clamp 10, the clamp 10 can be moved to a suitable position by manipulating the delivery conduit 21.

[0076] In an embodiment where the delivery conduit 21 has a through hole 212, the through hole 212 penetrates the distal and proximal ends of the delivery conduit 21. The operating member 224 passes through the through hole 212 and can move axially relative to the delivery conduit 21 along the through hole 212. Thus, the operating member 224 drives the constraint ring 223a connected to it to move toward the proximal end 223b of the constraint structure 223, so that the constraint ring 223a releases the radial restraint on the mating part 222b and the connecting part 111a, thereby allowing the clamp 222a and the connecting part 111a to separate from each other and complete the release of the clamp 10.

[0077] Combination Figure 6 As shown, the delivery conduit 21 has a central hole 211, which is not connected to the through hole 212. The central hole 211 allows for the adaptation of the structural components of the fixing seat connecting the clamp 10. Combined with... Figure 4 As shown, the release assembly 22 includes a spindle 221, which passes through the central hole 211 and the constraint structure 223. The connecting body 222 is located between the outer wall of the spindle 221 and the inner wall of the constraint structure 223. The distal end 221a of the spindle 221 passes through the constraint ring 223a and is detachably connected to the fixing seat of the clamp 10. The spindle 221 can move axially relative to the connecting body 222 to control the clamp 10 to open or close.

[0078] Specifically, in the embodiment where the clamp 10 includes a spacer 11, the connecting part 111a is located at the proximal end of the spacer 11. Then, when the clamping piece 222a of the connecting body 222 is connected to the connecting part 111a, the delivery conduit 21 is connected to the spacer 11 through the connecting body 222. Since the distal end 221a of the spindle 221 is connected to the fixed seat of the clamp 10, when the spindle 221 moves distally relative to the connecting body 222, the spacer 11 and the fixed seat move away from each other axially. The spacer 11 drives the two support arms to rotate relative to the two clamping arms respectively, so that the two support arms drive the two support arms to open away from the spacer 11. During this operation, the constraint ring 223a of the constraint structure 223 can limit the mating part 222b to the connecting part 111a along the radial direction of the constraint structure 223, thereby improving the connection stability between the connecting body 222 and the clamp 10 and preventing the clamp 10 from abnormally falling off the conveying device 20 and being released in an inappropriate position.

[0079] It should be noted that, in order to accommodate the control requirements of the mandrel 221 on the fixing seat of the clamp 10, a corresponding channel is provided on the spacer 11 to allow the mandrel 221 to pass through. Specifically, in conjunction with Figure 1 and Figure 4 As shown, the spacer 11 has a through hole along its axial direction, which passes through the proximal connecting part 11a and the distal connecting part 11b, so that the spindle 221 can pass through the through hole and be connected to the fixed seat 12.

[0080] In some implementations, combined Figure 2 and Figure 4 As shown, the distal end 221a of the spindle 221 is threadedly connected to the fixed seat 12 so that the spindle 221 can be quickly connected to or disconnected from the fixed seat 12 by manipulating the spindle 221 to rotate axially relative to the fixed seat 12.

[0081] In embodiments where the delivery conduit 21 has a central hole 211 and through holes 212, the number of through holes 212 can be two or more, thereby accommodating the need for multiple traction wires 10a or multiple operating elements 224. For example, combined with Figure 4 As shown, two traction wires 10a can be used to adjust the opening or closing of the hooks 14 located on both sides of the spacer 11.

[0082] Combination Figure 20 As shown, the distal end 21a of the delivery catheter 21 adopts an adjustable bend to facilitate adjustment of the direction of the clamp 10 connected to the push assembly 22, thereby adapting to accurately move the clamp 10 to the location where the valve needs repair.

[0083] In some implementations, combined Figure 6 As shown, the delivery conduit 21 has through holes 212 on both sides of the central hole 211. The central hole 211 extends along the longitudinal central axis of the delivery conduit 21, and the two through holes 212 are symmetrically arranged with the plane passing through the longitudinal central axis of the delivery conduit 21 as a mirror image. This layout is relatively simple, and the symmetrical structure is compatible with the symmetrical structure of the clamp 10, resulting in better operability.

[0084] In other embodiments, the two through holes 212 do not need to be distributed symmetrically on both sides of the central hole 211, as long as they can accommodate the traction wire 10a located within the through hole 212 to operate the corresponding hook 14 for opening and closing, or accommodate the operating member 224 located within the through hole 212 to operate the constraint ring 223a to move towards the proximal end 223b of the constraint structure 223. It should be noted that when the traction wire 10a and the operating member 224 adopt different through holes 212, the delivery conduit 21 can be configured with more non-communicating through holes 212, thereby allowing the traction wire 10a and the operating member 224 to move axially relative to the delivery conduit 21 without interference.

[0085] In some embodiments, the delivery tube 21 is made of PE (polyethylene), PI (polyimide), or TPU (thermoplastic polyurethanes). The mandrel 221 can be stainless steel, nickel-titanium, or any other metal or polymer material capable of achieving a similar result.

[0086] In some embodiments, the number of clips 222a on the connector 222 can be one, two, or more. For example, when there is one clip 222a on the connector 222, since the clip 222a has a mating part 222b that is detachably connected to the connecting part 111a of the clamp 10, when the restraint ring 223a confines the mating part 222b to the connecting part 111a along the radial direction of the restraint structure 223, the mating part 222b cannot disengage from the connecting part 111a. At this time, the mating of the connecting part 111a and the mating part 222b makes the connector 222 and the clamp 10 form a stable connection. Accordingly, when the operating member 224 moves the constraint ring 223a toward the proximal end 223b of the constraint structure 223, thereby releasing the constraint ring 223a from radially limiting the clamp 222a and the connecting part 111a, the mating part 222b of the clamp 222a can be separated radially from the connecting part 111a, thereby releasing the connection between the connecting body 222 and the clamp 10 and realizing the release of the clamp 10.

[0087] Accordingly, when the connector 222 includes two or more clips 222a, as long as one of the clips 222a is elastic, the constraint ring 223a can capture the connector 111a by binding the clip 222a, and when the constraint ring 223a releases the radial binding on the clip 222a, the clip 222a can be radially released to release the engagement with the connector 111a.

[0088] It should be noted that in other embodiments, since one of the clips 222a is elastic, even if the clip 222a does not have a mating part 222b, the clip 222a can still elastically clamp the proximal end of the implanted device under the radial constraint of the constraint ring. When the constraint ring contacts the radial constraint on the clip, the clip releases the proximal end of the implanted device.

[0089] For ease of understanding, the following will use... Figure 2 and Figure 3 The structure of the release assembly 22 is further explained by taking the connector 222 shown as an example, which includes two clips 222a.

[0090] Combination Figure 2 and Figure 3As shown, the connector 222 includes two clips 222a, which are spaced apart circumferentially along the connector 222. Figure 2 As shown, in one embodiment, both clips 222a are elastic. In their natural state, the two clips 222a are not radially restrained by the constraint ring 223a and open radially outward. Correspondingly, when the constraint ring 223a moves to the distal end of the clips 222a, the two clips 222a close inward under the radial restraint of the constraint ring 223a. For example... Figure 3 As shown, in another embodiment, only one of the two clips 222a is elastic, so that the two clips 222a can move relative to the connecting body 222 in the axial direction along the constraint structure 223 via the constraint ring 223a, thereby clamping the two clips 222a together or releasing the radial constraint on the clips 222a, thereby opening the two clips 222a together.

[0091] Based on this, when the connector 222 is provided with two or more clamping pieces 222a, as long as one of the clamping pieces 222a is elastic, the radial binding of the clamping piece 222a or the release of the radial binding of the clamping piece 222a can be achieved by the axial movement of the constraint ring 223a relative to the connector 222, thereby adapting to the clamping or releasing needs of the clamping piece 222a on the connecting part 111a.

[0092] Combination Figure 7 and Figure 8 As shown, the detachable connection structure between the mating part 222b and the connecting part 111a can be a snap-fit ​​connection. For example, the connecting part 111a is provided with a protrusion 111a, and the mating part 222b includes a groove or recess, or the groove or recess is provided in the connecting part 111a, and the protrusion 111a is located in the mating part 222b. Through the snap-fit ​​engagement of the protrusion 111a with the groove or recess, the connecting part 111a and the mating part 222b are limited in the axial direction. At the same time, the clamping piece 222a is radially limited to the connecting part 111a by the constraint ring 223a along the constraint structure 223, so that the clamping piece 222a is radially limited to the connecting part 111a. Ultimately, the connecting body 222 cannot be disengaged from the connecting part 111a, thus achieving the purpose of stable connection between the release component 22 and the clamp 10. When it is necessary to release the clamp 10, the constraint ring 223a is moved from the far end to the near end and toward the near end of the clamp 222a by the operating member 224, so that the constraint ring 223a leaves the mating position of the clamp 222a and the connecting part 111a, thereby releasing the radial restraint of the constraint ring 223a on the mating part 222b and the connecting part 111a, so that the connecting body 222 and the connecting part 111a of the clamp 10 can be separated from each other.

[0093] It should be noted that in embodiments where the mating part 222b and the connecting part 111a are connected by a snap-fit, the groove can be a through groove or a blind groove. In some embodiments, combined with... Figure 9 As shown, the groove corresponding to the mating part 222b extends circumferentially to the edge of the clamping piece 222a, forming a hook-shaped structure on the clamping piece 222a. At this time, after the connecting part 111a and the mating part 222b are engaged, there is an axial constraint force between them. A stable connection can be achieved under the radial constraint of the constraint ring 223a. When the constraint ring 223a releases the radial constraint, the connecting part 111a and the mating part 222b can be separated, realizing the controllable release of the clamp 10.

[0094] Combination Figure 7 and Figure 8 As shown, the connector 111 includes a shaft hole 111b and a protruding ridge 111c surrounding the shaft hole 111b. Figure 11 and Figure 15 As shown, when the constraint ring 223a radially limits the mating part 222b to the connector 111, the constraint ring 223a abuts against the protrusion 111c. In this way, the protrusion 111c can play a good limiting effect on the constraint ring 223a in the axial direction, so that the constraint ring 223a is kept at the position where the mating part 222b is set on the clamp 222a, thereby improving the radial limiting stability of the constraint ring 223a on the mating part 222b and the connector 111.

[0095] It should be noted that the contact between the constraint ring 223a and the protrusion 111c can be either that the constraint ring 223a just moves axially to contact the protrusion 111c, or that the constraint ring 223a presses against the protrusion 111c under the action of the axial elastic force of the constraint structure 223 itself. Since the mating part 222b and the connector 111 are mated at this time, the two are axially limited to each other. Then, when the constraint ring 223a presses against the protrusion 111c, the force acting on the protrusion 111c can pull the connector 111 relative to the connecting body 222 towards the far end. In this way, the mating part 222b and the connecting part 111a can maintain the connection between the two, and at the same time, the two will not loosen under the action of the tensioning force, thereby maintaining the stability of the conveying device 20 when conveying the clamp 10.

[0096] The connector 222 is made by cutting a metal tube. This processing method is relatively simple, the technology is mature, and the manufacturing cost is low.

[0097] In some implementations, combined Figure 10 and Figure 11As shown, the proximal end 223b of the constraint structure 223 can be fixed to the connector 222. When the operating member 224 moves towards the proximal end relative to the connector 222, the operating member 224 can drive the constraint ring 223a to approach the proximal end 223b of the constraint structure 223, thereby releasing the radial restraint on the clamp 222a and allowing the clamp 222a to separate from the connector 111a.

[0098] The proximal end 223b of the constraint structure 223 can be sleeved on the connector 222. The connector 222 extends proximally from the proximal end 223b of the constraint structure 223. When the connector 222 is connected to the delivery conduit 21, the proximal end 223b of the constraint structure 223 is fixed relative to the delivery conduit 21. When the mandrel 221 moves axially relative to the delivery conduit 21, the mandrel 221 can drive the fixed seat of the clamp 10 to move relative to the spacer 11, thereby completing the opening or closing operation of the clamp 10.

[0099] In other implementations, such as Figure 14 and Figure 15 As shown, the proximal end 223b of the constraint structure 223 can be fixed at the proximal end of the connector 222. In this way, the proximal end 223b of the constraint structure 223 can be connected to the distal end of the delivery conduit 21 together with the connector 222, thereby improving the stability of the overall structure.

[0100] It should be noted that the stretchable structure can be used for cutting spiral tubes or weaving mesh tubes.

[0101] In other embodiments, the entire constraint structure 223 is cut from a metal tube to form a corresponding telescopic structure and a constraint ring 223a located at the distal end of the telescopic structure. For example, combined with Figure 12 and Figure 13 As shown, after the metal tube is cut, a telescopic structure 223c is formed between the proximal end 223b of the constraint structure 223 and the constraint ring 223a. This telescopic structure enables an elastic connection between the proximal end 223b and the constraint ring 223a, resulting in a constraint structure 223 with axial telescopic properties. The proximal end 223b and the constraint ring 223a of the constraint structure 223 can have a certain length, i.e., they are tubular. This tubular shape allows for good radial coverage of the proximal end 223b and the constraint ring 223a, improving the stability of the constraint structure 223 during telescopic movement outside the connector 222.

[0102] In other embodiments, the constraint structure 223 can be formed by welding or riveting multiple components together. For example, the constraint structure 223 includes two collars and an elastic segment, with the two collars connected to both ends of the elastic segment to form the proximal end 223b and constraint ring 223a of the constraint structure 223, respectively. The elastic segment is not limited to a spring. The structure of the constraint structure 223 is not limited here, as long as the constraint structure 223 can extend and retract axially and forms a constraint ring 223a and a proximal end 223b of the constraint structure 223 opposite to the constraint ring 223a, to meet the needs of radial restraint of the clamp 222a and the connecting portion 111a.

[0103] In some other embodiments, the proximal end 223b of the constraint structure 223 may not be connected to the connector 222. For example, the proximal end 223b of the constraint structure 223 may be directly fixedly connected to the distal end of the delivery conduit 21. In this case, the constraint ring 223a of the constraint structure 223 can still be pulled by manipulating the operating member 224, so that the constraint ring 223a moves toward the proximal end 223b of the constraint structure 223.

[0104] The operating element 224 can be a filamentous structure similar to the traction wire 10a, or a flexible structure such as a rope or steel wire. The structure of the operating element 224 is not limited here, as long as the operating element 224 can adapt to the traction requirements of the constraint ring 223a and can adapt to the bending requirements of the delivery conduit 21.

[0105] Combination Figure 16 As shown, during valve repair using the valve clamping system 100, the sheath 101 passes through the femoral vein and inferior vena cava to the right atrium 001, then punctures the interatrial septum 005, with the distal end 101a of the sheath 101 reaching the left atrium 002. The distal end 101a of the sheath 101 is adjusted to be positioned midway above the mitral valve 004. Combined with... Figure 17 As shown, after adjusting the position of the sheath 101, the clamp 10 connected to the distal end of the delivery catheter 21 is output from the distal end 101a of the sheath 101 by the delivery catheter 21, so that the clamp 10 is pushed to the mitral valve position 004. Figure 4 and Figure 18 As shown, after the clamp 10 is pushed to the appropriate position, the clamping arm 132 of the clamp 10 is opened by manipulating the mandrel 221 inside the delivery catheter 21. This allows the traction wire 10a to be moved proximally relative to the delivery catheter 21, using the traction wire 10a to pull the hook 14, causing the hook 14 to open relative to the support arm 131, thereby capturing the leaflet of the mitral valve 004. Combined with... Figure 5 and Figure 19As shown, when the leaflet is between the hook 14 and the support arm 131, the traction wire 10a is released to pull the hook 14, causing the hook 14 to return to its original shape and clamp the leaflet. Combined with... Figure 20 As shown, after the hook 14 and support arm 131 clamp the leaflets, the clamping device 10 clamps the two leaflets of the mitral valve 004 together by manipulating the spindle 221. At this point, the clamping device 10 clamps the leaflets. At this time, as... Figure 21 As shown, the conveying conduit 21 of the conveying device 20 remains connected to the clamp 10. (Combined) Figure 22 After clamping the leaflets of clamping device 10, the traction wire 10a is removed from hook 14. Figure 23 As shown, after disconnecting the mandrel 221 from the fixed base 12, the mandrel 221 is retracted proximally relative to the delivery guide tube 21, so that the mandrel 221 is removed from the clamp 10. Figure 24 As shown, after the mandrel 221 is removed from the clamp 10, the control element 24 can be manipulated to move the constraint ring 223a of the constraint structure 23 toward the proximal end 223b of the constraint structure 223, thereby releasing the connection between the constraint ring 223a of the constraint structure 23 and the clamp 222a and the connecting part 111a, thus completing the release of the clamp 10. At this time, the conveying device 20 can be separated from the clamp 10 and withdrawn (see...). Figure 25 (As shown).

[0106] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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.

[0107] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A release assembly for controllably releasing an implantable device, the implantable device having a connecting portion, characterized in that, The release assembly includes: a connector having at least two clips extending distally, the at least two clips being circumferentially spaced along the connector and each having a mating portion, and at least one of the at least two clips being elastic; A constraint structure, the proximal end of which is fixedly connected to the connector, includes a constraint ring, the constraint ring being detachably sleeved on the connector, and the constraint ring being axially movable relative to the connector; When the restraint ring moves from the proximal end to the distal end and toward the proximal end away from the clips, the at least two clips clamp each other under the radial restraint of the restraint ring, thereby clamping the implanted device. When the restraint ring moves from the distal end to the proximal end and toward the proximal end of the clips, the restraint ring releases the radial restraint on the at least two clips, and the at least two clips open apart to release the implanted device. After separating from the implanted device, they are withdrawn along with the release assembly. The constraint structure further includes a retractable structure connected to the constraint ring. The portion of the constraint structure that is fixedly connected to the connecting body is located on the proximal side of the retractable structure, and the constraint ring is located on the distal side of the retractable structure. The retractable structure causes the constraint ring to have a tendency to move towards the distal end of the clip relative to the portion of the constraint structure that is fixedly connected to the connecting body. The release assembly further includes an operating member connected to the constraint ring, which can move the constraint ring toward the proximal end of the clamping piece. The constraint ring can be misaligned with the mating part in the length direction of the clamping piece to release the radial restraint of the constraint ring on the mating part and the connecting part.

2. The release component according to claim 1, characterized in that, Both of the clamping pieces are elastic elements.

3. The release component according to claim 1, characterized in that, Along the radial direction of the implantable device, the mating part is detachably connected to the connecting part of the implantable device, and through the mating part and the connecting part, the connecting part is axially limited to the connecting body; When the constraint ring moves to the point where at least a portion of it radially overlaps with at least a portion of the connecting portion, and at least a portion of the constraint ring radially overlaps with at least a portion of the mating portion of the clip, the constraint ring is used to limit the mating portion to the connecting portion of the implanted device along the radial direction of the constraint structure.

4. The release component according to claim 3, characterized in that, When the constraint ring moves to the point where at least a portion of it radially overlaps with at least a portion of the connecting portion, and at least a portion of the constraint ring radially overlaps with at least a portion of the mating portion of the clamping piece, the connecting portion and the mating portion overlap at least a portion in the length direction of the clamping piece.

5. The release component according to claim 3, characterized in that, The central angle corresponding to the constraint ring is greater than 180°.

6. The release component according to claim 3, characterized in that, The constraint ring is a closed ring-shaped component.

7. The release component according to claim 3, characterized in that, One of the mating part and the connecting part is a protrusion, and the other is a groove or a recess.

8. The release component according to claim 1, characterized in that, The proximal end of the constraint structure is fixedly connected to the connector.

9. The release component according to claim 1, characterized in that, The retractable structure is a cut spiral tube or a braided mesh tube.

10. The release assembly according to claim 1, characterized in that, When the release component is connected to the implanted device, the retractable structure is in an axially contracted state.

11. A conveying device, characterized in that, The release component as described in any one of claims 1 to 10.

12. A valve clamping system, characterized in that, The device includes an implantable device and a delivery device as described in claim 11, wherein the delivery device is detachably connected to the implantable device via the release assembly, and the connection portion is disposed at the proximal end of the implantable device.

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