Control modules and conveying systems

Abstract

The present invention discloses a control module and a delivery system, wherein the control module controls the implantation of a valve clamp, wherein the valve clamp includes at least two first clamp arms, and the control module includes: a first shell; a control tube, wherein the control tube is partially arranged in the first shell and partially arranged outside the first shell, and at least two first through-holes are arranged on the part of the control tube located outside the first shell; at least two first pulling components, wherein at least two of the first pulling components are respectively inserted into at least two of the first through-holes and are connected with at least two of the first clamp arms in a one-to-one corresponding manner; the control tube selectively moves axially along the first shell in the first shell to pull all of the first clamp arms, and the first pulling component selectively moves axially along the first through-hole in the first through-hole to pull a corresponding one of the first clamp arms.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a control module and a delivery system. Background Art

[0002] Mitral regurgitation (MR) is one of the most common heart valve diseases. In recent years, with the breakthrough development of valve interventional treatment technology, MR interventional devices have become one of the key directions of cardiovascular device research and development at home and abroad.

[0003] Among the related technologies, the valve clamping device developed based on the principle of surgical valve edge-to-edge suturing technology is currently more recognized because of its high safety, simple technical principle and high feasibility. However, during surgery, the device needs to pass through the inferior vena cava, right atrium, atrial septum, left atrium and finally reach the left ventricle. The access route is long and has many bends, so the operation is very complicated. The doctor needs to repeatedly fine-tune the curvature, direction, horizontal position, and vertical depth of the delivery system. After reaching the ideal position, the opening or clamping degree of the valve clamp must be repeatedly adjusted to clamp the valve, so the operation takes a long time. In order to reduce the operation time and improve the success rate of the operation, it is necessary to provide a control module and its delivery system that can achieve complex control through simple operation, so that the doctor can achieve fine movements of the distal instrument by simple control at the proximal end. Summary of the invention

[0004] The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, the present invention proposes a control module, which can pull any first clamping arm of the valve clamp by controlling at least two first pulling components, or can directly control at least two first clamping arms at the same time through a control tube, so that the valve clamp can clamp the valve leaflet, and the operation is simple and convenient.

[0005] The present invention also provides a delivery system for controlling the delivery and implantation of a valve clip.

[0006] According to the control module of the first aspect of the present invention, the control module controls the implantation of the valve clamp, and the valve clamp includes at least two first clamp arms. The control module includes: a first shell; a control tube, the control tube is partially arranged in the first shell, and partially arranged outside the first shell, and at least two first through-holes are arranged on the part of the control tube located outside the first shell; at least two first pulling components, at least two of the first pulling components are respectively inserted into at least two of the first through-holes and are matched and connected with at least two of the first clamp arms in a one-to-one correspondence; the control tube selectively moves along the axial direction of the first shell in the first shell to pull all the first clamp arms, and the first pulling component selectively moves along the axial direction of the first through-hole in the first through-hole to pull a corresponding one of the first clamp arms.

[0007] According to the control module of the embodiment of the present invention, the operator can pull a corresponding first clamp arm of the valve clamp by controlling any one of the at least two first pulling components to control the first clamp arm to open or clamp. In addition, the control tube can be driven to move along the axial direction of the first shell, so that the control tube drives all the first pulling components to move, so that all the first clamp arms can be controlled to open or clamp. The operation is simple and can be flexibly adjusted, which effectively improves the operating efficiency, so that the valve clamp can achieve mitral valve clamping at the left ventricle.

[0008] According to some embodiments of the present invention, the control module further includes: a first adjusting member, which is disposed in the first shell and is transmission-connected to a portion of the control tube located in the first shell to drive the control tube to move in an axial direction of the first shell.

[0009] According to some embodiments of the present invention, a first threaded portion is provided on the inner side of the first adjusting member, a second threaded portion is provided on the outer side of the portion of the control tube located in the first shell, the first threaded portion and the first threaded portion are meshed for transmission, and the first adjusting member is axially limited in cooperation with the first shell.

[0010] According to some embodiments of the present invention, a limiting step is provided on the circumference of the first adjusting member, a limiting groove is provided on the first shell, and the limiting step and the limiting groove are limitedly matched.

[0011] According to some embodiments of the present invention, at least a portion of the first adjusting member is exposed relative to the first shell.

[0012] According to some embodiments of the present invention, the first adjusting member is provided with anti-slip teeth.

[0013] According to some embodiments of the present invention, the control tube includes: a first tube body and at least two second tube bodies, at least two second tube bodies are arranged at the distal end of the first tube body, the first tube body is arranged in the first shell, the second tube body passes through the first shell and extends out of the first shell, and one of the second tube bodies is provided with a first through hole opened along the axial direction of the second tube body.

[0014] According to some embodiments of the present invention, the first adjusting member is sleeved outside the proximal end of the first tube body.

[0015] According to some embodiments of the present invention, the first tube body is arranged in the first shell along the axial direction of the first shell, at least two second tube bodies are distributed at intervals along the circumference of the first tube body, and at least two second tube bodies are inclined in the circumferential direction of the first tube body.

[0016] According to some embodiments of the present invention, the first shell further includes: at least two avoidance holes and at least two protective covers, at least two of the protective covers are respectively arranged above the at least two avoidance holes, at least two of the second tubes are respectively penetrated by at least two of the avoidance holes, and at least two of the second tubes move in the at least two avoidance holes driven by the first tube, and the protective covers are selectively covered on the second tubes.

[0017] According to some embodiments of the present invention, the protective cover is tilted at the distal end of the avoidance hole at the same angle as that of the second tube body. When the second tube body moves to the distal end of the avoidance hole, a portion of the second tube body fits with the protective cover.

[0018] According to some embodiments of the present invention, the first pulling member includes: a first pulling member and a first control member, the first pulling member is inserted into the first through-hole, the first control member is inserted into the first through-hole and fixedly connected to the first pulling member, and the first control member selectively moves along the axial direction of the first through-hole in the first through-hole to pull the first pulling member.

[0019] According to some embodiments of the present invention, the first pulling member is a high-modulus, low-shrinkage polymer wire, for example, an ultra-high-strength polyethylene wire.

[0020] According to some embodiments of the present invention, a first limiting portion is provided on a circumferential portion of the first control member, an avoidance portion is provided on another circumferential portion of the first control member, and a second limiting portion is provided on the inner side of the first through-hole. When the first limiting portion and the second limiting portion are opposite to each other, the first limiting portion and the second limiting portion are limitedly matched; when the avoidance portion and the second limiting portion are opposite to each other, the first control member moves in the first through-hole along the axial direction of the first through-hole.

[0021] According to some embodiments of the present invention, a handle portion is provided at one end of the first control member facing away from the first shell.

[0022] According to some embodiments of the present invention, a thread is provided at the top of the first control member facing away from the first shell, and a screw cap is correspondingly provided at the top of the first control member. The first control member is a hollow structure with two ends passing through. After the first pulling member passes through the first through hole, it passes through the first control member and passes out from the top of the first control member. The first control member is detachably threadedly connected to the screw cap through the thread, so that the first pulling member is fixed on the first control member.

[0023] According to some embodiments of the present invention, the control module also includes: a second pulling component, the second pulling component includes: a second pulling piece, a second control piece and a third tube body, the third tube body is arranged on the first shell and a second through hole is arranged in the third tube body along the axial direction of the third tube body, the second pulling piece passes through the second through hole, the second control piece is inserted into the second through hole and fixedly connected to the second pulling piece, and the second control piece selectively moves in the second through hole along the axial direction of the second through hole to pull the second pulling piece.

[0024] According to some embodiments of the present invention, a first limiting portion is provided on a circumferential portion of the second control member, an avoidance portion is provided on another circumferential portion of the second control member, and a second limiting portion is provided on the inner side of the second through-hole; when the first limiting portion and the second limiting portion are opposite to each other, the first limiting portion and the second limiting portion are limitedly matched; when the avoidance portion and the second limiting portion are opposite to each other, the second control member moves in the second through-hole along the axial direction of the second through-hole.

[0025] According to some embodiments of the present invention, a handle portion is provided at one end of the second control member facing away from the first shell.

[0026] According to some embodiments of the present invention, a thread is provided at the top of the second control member facing away from the first shell, and a screw cap is correspondingly provided at the top of the second control member. The second control member is a hollow structure with two ends passing through. After the second pulling member passes through the second through hole, it passes through the second control member and passes out from the top of the second control member. The second control member is detachably threadedly connected to the screw cap through the thread, so that the second pulling member is fixed on the second control member.

[0027] According to some embodiments of the present invention, the control module further includes: a second adjusting member and a traction member, the second adjusting member is arranged on the first shell and spaced apart from the first adjusting member, the second adjusting member and the traction member are transmission-connected to selectively drive the traction member to move in the axial direction of the first shell.

[0028] According to some embodiments of the present invention, the control module further includes: a mounting sleeve, which is mounted on the traction member and fixedly connected to the traction member, the mounting sleeve is provided with an external thread, the second adjustment member is provided with an internal thread, and the second adjustment member is axially limitedly matched with the first shell.

[0029] According to some embodiments of the present invention, the control module further includes: a clamping member, which is disposed on the mounting sleeve and selectively fixes the traction member.

[0030] According to some embodiments of the present invention, the clamping member comprises: a collet nut, a collet core and a collet shaft. The collet core is a four-petal spring structure, the collet shaft is inserted on the mounting sleeve, the collet core is inserted in the collet shaft, the traction member passes through the collet shaft and the collet core, and the collet nut is detachably threadedly connected to the collet shaft.

[0031] According to some embodiments of the present invention, a fixing hole is provided on the chuck shaft, and the clamping member further comprises: a fixing screw, and the fixing screw is detachably threadedly engaged with the fixing hole to resist the traction member.

[0032] According to the delivery system of the second aspect of the present invention, the delivery system is used to deliver and implant the valve clamp, and includes: the control module of the above embodiment, the control module also includes: a multi-lumen tube, the first traction member passes through the multi-lumen tube, and the valve clamp is arranged at the distal end of the multi-lumen tube; a delivery module, the delivery module and the control module are connected, the delivery module includes: a delivery sheath, the multi-lumen tube passes through the delivery sheath; a guide module, the guide module is connected to the side of the delivery module away from the control module, the guide module includes: a guide sheath and an expansion tube, any one of the delivery sheath and the expansion tube passes through the guide sheath.

[0033] According to some embodiments of the present invention, the conveying module and the guide module both include: a bending control assembly, the bending control assembly includes: a second shell, a threaded tube, a third adjusting member, and a pull wire, the threaded tube and the third adjusting member are both arranged in the second shell, the third adjusting member is sleeved on the threaded tube and is axially limited with the second shell, one end of the pull wire is fixedly connected to the threaded tube, and the other end of the pull wire is connected to the conveying sheath or the guide sheath, a third threaded portion is provided on the inner side of the third adjusting member, and a fourth threaded portion is provided on the outer side of the threaded tube, the third threaded portion and the fourth threaded portion are threadedly matched to realize the axial movement of the threaded tube along the second shell.

[0034] According to some embodiments of the present invention, the bending control assembly further includes: a wire locking device, wherein the wire locking device is fixed to the threaded tube, and the wire is passed through the wire locking device.

[0035] According to some embodiments of the present invention, the wire tensioner includes: a main body, a pin shaft and an elastic member, one end of the main body is fixed to the threaded tube and the other end is provided with a step portion, a conical hole is opened on the main body, the end with a larger hole diameter of the conical hole is close to the step portion, the pin shaft passes through the conical hole of the main body and selectively moves in the conical hole, the elastic member is sleeved on the main body, one end of the elastic member abuts against the pin shaft and the other end abuts against the step portion.

[0036] According to some embodiments of the present invention, the lower end of the main body is square, and a square groove is correspondingly formed on the end surface of the threaded tube.

[0037] According to some embodiments of the present invention, the bending control assembly further includes: a connecting member and an indicator member, one end of the connecting member is connected to the threaded tube and the other end is connected to the indicator member, the indicator member selectively moves in the axial direction of the second shell, and the second shell is provided with a window to expose the indicator member.

[0038] According to some embodiments of the present invention, a slot is provided at the end of the threaded tube for snap-fitting with the connector.

[0039] According to some embodiments of the present invention, the bending control assembly also includes: a guide tube, the guide tube is arranged in the threaded tube, a first sliding part is arranged on the outer side of the guide tube, and a second sliding part is arranged on the inner side of the threaded tube, the first sliding part is one of a slide groove and a slider, the second sliding part is the other of the slide groove and the slider, and the slide groove and the slider are slidably connected.

[0040] According to some embodiments of the present invention, a travel limit block is provided on the second shell body for limiting the sliding travel of the threaded tube.

[0041] According to some embodiments of the present invention, the bending angle of the guide sheath is 0-120°.

[0042] According to some embodiments of the present invention, the guide sheath is a composite sheath tube, the inner layer is a polymer layer, the middle layer is a metal layer, which is a braided metal wire or a cut metal tube, and the outer layer is a polymer layer.

[0043] According to some embodiments of the present invention, the outer layer of the guide sheath includes: a first end segment, a first bending control segment and a first main segment, wherein the hardness of the first bending control segment is less than the hardness of the first end segment, and the hardness of the first bending control segment is less than the hardness of the first main segment.

[0044] According to some embodiments of the present invention, the bending angle of the delivery sheath is 0-120°.

[0045] According to some embodiments of the present invention, the delivery sheath is a composite sheath tube, the inner layer is a polymer layer, the middle layer is a metal layer, which is a braided metal wire or a cut metal tube, and the outer layer is a polymer layer.

[0046] According to some embodiments of the present invention, the outer layer of the conveying sheath includes: a second end section, a second bending control section, a compliant section and a second main section, wherein the hardness of the compliant section ≤ the hardness of the second bending control section < the hardness of the second end section, and the hardness of the second bending control section < the hardness of the second main section.

[0047] According to some embodiments of the present invention, the length of the compliant section is greater than the length of the first bending control section.

[0048] Additional aspects and advantages of the present invention will be given in part in the following description and in part will be obvious from the following description, or will be learned through practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The above and / or additional aspects and advantages of the present invention will become apparent and easily understood from the description of the embodiments in conjunction with the following drawings, in which:

[0050] Figure 1 is a schematic diagram of the structure of a control module according to an embodiment of the present invention;

[0051] Figure 2 yes Figure 1 Schematic cross-sectional view of ;

[0052] Figure 3 is a schematic structural diagram of a first pulling assembly according to an embodiment of the present invention;

[0053] Figure 4 is a schematic structural diagram of a first control component according to an embodiment of the present invention;

[0054] Figure 5 is an exploded schematic diagram of a clamping member according to an embodiment of the present invention;

[0055] Figure 6 is a schematic structural diagram of the guide sheath and the dilation tube of the guide module according to an embodiment of the present invention when they cooperate with each other;

[0056] Figure 7 is a schematic structural diagram of a guide sheath and a dilation tube of a guide module according to an embodiment of the present invention when they are separated;

[0057] Figure 8 is a schematic structural diagram of a conveying module and a control module according to an embodiment of the present invention;

[0058] Fig. 9 is a schematic structural diagram of a conveying system according to an embodiment of the present invention;

[0059] Fig.10 is a cross-sectional schematic diagram of a multi-lumen tube according to an embodiment of the present invention;

[0060] Fig.11 is a schematic structural diagram of a bending control assembly according to an embodiment of the present invention;

[0061] Fig.12 yes Fig.11 Schematic cross-sectional view of ;

[0062] Fig.13 is a partial schematic diagram of a bending control assembly according to an embodiment of the present invention;

[0063] Fig.14 is a schematic structural diagram of a wire tensioner according to an embodiment of the present invention at one angle;

[0064] Fig.15 is a schematic structural diagram of a wire tensioner according to another angle of an embodiment of the present invention;

[0065] Fig.16 is a schematic structural diagram of a threaded pipe according to an embodiment of the present invention;

[0066] Fig.17 is a schematic structural diagram of an introducer sheath according to an embodiment of the present invention;

[0067] Fig.18 is a schematic structural diagram of a delivery sheath according to an embodiment of the present invention;

[0068] Fig.19 is a schematic diagram of a process 1 of implanting a valve clipper by a delivery system according to an embodiment of the present invention;

[0069] Fig. 20is a schematic diagram of a second process of implanting a valve clipper by a delivery system according to an embodiment of the present invention;

[0070] Fig.21 is a schematic diagram of process three of implanting a valve clipper by a delivery system according to an embodiment of the present invention;

[0071] Fig. 22 is a schematic diagram of a fourth process of implanting a valve clipper by a delivery system according to an embodiment of the present invention;

[0072] Fig.23 FIG. 5 is a schematic diagram of process 5 of implanting a valve clip using a delivery system according to an embodiment of the present invention.

[0073] Reference numerals:

[0074] S1, valve clip;

[0075] S2, conveying system;

[0076] 100. Control module;

[0077] 10. first shell; 12. avoidance hole; 13. protective cover; 14. second through hole;

[0078] 20. control tube; 22. first through hole; 23. second threaded portion; 24. first tube body; 25. second tube body; 26. second limit portion; 27. third tube body; 28. screw cap;

[0079] 30. first pulling assembly; 31. first pulling member; 32. first control member; 321. first limiting portion; 322. avoidance portion; 323. hand-locking portion;

[0080] 40. first adjusting member; 41. limiting step;

[0081] 50. Second pulling assembly; 51. Second pulling member; 52. Second control member;

[0082] 60. Second adjusting member;

[0083] 70; traction member; 71, mounting sleeve; 80, clamping member; 81, collet nut; 82, collet core; 83, collet shaft; 84, fixing hole; 90, multi-lumen tube; 91, first chamber; 92, second chamber; 93, central chamber;

[0084] 200, conveying module;

[0085] 210, delivery sheath;

[0086] 220, bending control assembly; 230, second housing; 240, threaded tube; 241, fourth threaded portion; 242, second sliding portion; 243, groove; 244, slot; 250, third adjusting member; 260, pull wire; 270, pull wire locker; 271, main body; 272, pin shaft; 273, elastic member; 274, step portion; 275, tapered hole; 280, connecting member; 290, indicator; 300, guide tube; 310, travel limit block;

[0087] 400, guidance module;

[0088] 410, guide sheath; 420, dilation tube; 430, guide wire;

[0089] 500. Connector. DETAILED DESCRIPTION

[0090] The embodiments of the present invention are described in detail below. The embodiments described with reference to the accompanying drawings are exemplary and should not be regarded as specific limitations of the present invention.

[0091] Reference below Figure 1-Figure 23 The control module 100 according to the first aspect of the present invention is described, which is used to control the implantation of the valve clip S1, and the present invention also proposes a delivery system S2 having the above-mentioned control module 100, which is used to control the delivery and implantation of the valve clip S1. The specific structure of the valve clip S1 refers to the structure of the valve clip described in CN202111041593.2, but the control module 100 and the delivery system S2 of the present invention are not limited thereto, and other valve clips of the same or similar structure are also applicable. In addition, the control object can also be adaptively adjusted. For example, one of the control units in the control module 100 is controlled by pulling. In one of the valve clippers, the first clamp arm can be controlled by pulling, and in another valve clipper, the core shaft can be controlled by pulling. Then, the control unit is suitable for controlling the first clamp arm and the core shaft. When cooperating with different valve clippers, different control objects can be controlled by adaptive adjustment. That is, when the control module 100 cooperates with one of the valve clippers, the control unit can be used to control the first clamp arm, and when the control module 100 cooperates with another valve clipper, the control unit can be used to control the core shaft. In addition, the proximal end mentioned below refers to the end close to the operator when the operator operates, and the distal end refers to the end away from the operator when the operator operates.

[0092] like Figure 1 and Figure 2 As shown, the control module 100 includes: a first shell 10 , a control tube 20 , at least two first pulling components 30 and a first adjusting member 40 .

[0093] The first housing 10 is a substantially columnar hollow structure.

[0094] The control tube 20 is partially disposed inside the first shell 10 and partially disposed outside the first shell 10 . At least two first through holes 22 are disposed on the portion of the control tube 20 located outside the first shell 10 .

[0095] At least two first pulling components 30 are respectively inserted into at least two first through-holes 22 , that is, one pulling component 30 is inserted into one first through-hole 22 .

[0096] The control tube 20 as a whole selectively moves axially relative to the first housing 10 to pull the first clamp arms of all valve clamps S1. The first pulling assembly 30 selectively moves axially relative to the first through hole 22 in the corresponding first through hole 22 to pull a corresponding first clamp arm of the valve clamp S1.

[0097] That is to say, the number of the first pulling components 30, the first through-holes 22 and the first clamping arms corresponds to each other. In this way, when any first pulling component 30 is driven to move axially relative to the first through-hole 22 in the corresponding first through-hole 22, a corresponding first clamping arm of the valve clamp S1 can be pulled to control the opening or clamping of the first clamping arm. Such an operation structure is simple and convenient for the operator. In addition, the axial movement of the control tube 20 relative to the first housing 10 can be utilized so that at least two first pulling components 30 can move axially relative to the first housing 10 at the same time, thereby pulling all the first clamping arms of the valve clamp S1 at the same time. In this way, by pulling at least two first pulling components 30 at the same time and pulling one of at least two first pulling components 30 individually, the operator can perform simultaneous control and individual control, and can also make fine adjustments according to the actual opening or clamping of the first clamping arm, so as to realize the remote and precise operation of the valve clamp S1 by the control module 100. It can be understood that the valve clip S1 is used to clip the mitral valve and has two first clamping arms. Accordingly, the control module 100 is provided with two pulling assemblies. In other embodiments not shown, more than two pulling assemblies can be provided to adapt to other types of valve clips.

[0098] In addition, the first adjusting member 40 is arranged in the first housing 10, and the first adjusting member 40 is transmission-connected with the part of the control tube 20 located in the first housing 10, so as to drive the control tube 20 to move axially relative to the first housing 10 as a whole. In this way, by controlling the first adjusting member 40, the control tube 20 can be driven to move axially relative to the first housing 10 as a whole. And because the first pulling assembly 30 is arranged on the control tube 20, the control tube 20 can drive the first pulling assembly 30 to move, so as to realize the control of all the first clamping arms of the valve clamp S1. Compared with directly operating at least two first pulling assemblies 30, the operator does not need to operate at least two first pulling assemblies 30 at the same time. Only by controlling the first adjusting member 40, the control tube 20 can pull at least two first pulling assemblies 30 at the same time, so that at least two first pulling assemblies 30 can pull all the first clamping arms of the valve clamp S1, which is convenient and efficient to operate, and greatly improves the operator's work efficiency.

[0099] Thus, the operator can pull a corresponding first clamp arm of the valve clamp S1 by controlling any one of the at least two first pulling components 30, so that the valve clamp S1 can accurately clamp the mitral valve in the left atrium, and the operation is simple and convenient. In addition, the control tube 20 can be driven to move by the first adjusting member 40, so that the control tube 20 controls the movement of the first pulling component 30. In this way, the operator only needs to operate the first adjusting member 40 to control all the first clamp arms of the valve clamp S1, which effectively improves the efficient operation of the control module 100.

[0100] At least a portion of the first adjusting member 40 is exposed relative to the first housing 10 , which makes it convenient for the operator to operate, that is, it makes it convenient for the operator to control all the first clamping arms.

[0101] like Figure 2As shown, a first threaded portion is provided inside the first adjusting member 40, and a second threaded portion 23 is provided outside the portion of the control tube 20 located inside the first housing 10, and the first threaded portion and the second threaded portion 23 are meshed for transmission, and the first adjusting member 40 is axially limited with the first housing 10. In this way, through the transmission cooperation of the first threaded portion and the second threaded portion 23, when the first adjusting member 40 rotates circumferentially, the control tube 20 can move axially relative to the first housing 10, so that the structure is compact and occupies less space, so that the control module 100 has the characteristics of being small, light, and easy to operate. In addition, the first adjusting member 40 is axially limited with the first housing 10, which can prevent the first adjusting member 40 from moving axially along the first housing 10, thereby ensuring that the control tube 20 only moves axially relative to the first housing 10, and avoiding the control tube 20 from rotating circumferentially along the first housing 10. Among them, at least part of the first adjusting member 40 is exposed relative to the first housing 10, so that it is convenient for the operator to rotate the first adjusting member 40. Furthermore, the first adjusting member 40 is provided with anti-slip teeth, which makes it more convenient for the operator to operate.

[0102] Among them, a limiting step 41 is provided on the circumference of the first adjusting member 40, and a limiting groove is provided on the first housing 10. The limiting step 41 and the limiting groove are limitedly matched to prevent the first adjusting member 40 from axially moving relative to the first housing 10. In this way, the limiting step 41 of the first adjusting member 40 is stuck in the limiting groove, which can not only realize the circumferential rotation of the first adjusting member 40 along the first housing 10, but also limit the axial movement of the first adjusting member 40 along the first housing 10, and the structure is simple and easy to install. In addition, only when the axial movement of the first adjusting member 40 along the first housing 10 is limited, the rotation of the first adjusting member 40 can realize the axial movement of the control tube 20 along the first housing 10.

[0103] It is understandable that in other embodiments not shown, the first adjustment member 40 may be omitted, and the operator may operate the control tube 20 through other structures or methods, for example, directly moving the control tube 20 to make it move axially relative to the first shell 10.

[0104] The control tube 20 includes: a first tube body 24 and at least two second tube bodies 25, at least two second tube bodies 25 are arranged at the distal end of the first tube body 24, the first tube body 24 is arranged in the first housing 10, the first adjusting member 40 is sleeved outside the proximal end of the first tube body 24, the second tube body 25 penetrates the first housing 10 and extends out of the first housing 10, and one second tube body 25 is provided with a first through hole 22 opened along the axial direction of the second tube body 25. In other words, the first through hole 22 is provided on the second tube body 25, the first pulling assembly 30 is arranged in the first through hole 22, and the number of the first pulling assembly 30, the second tube body 25 and the first through hole 22 is correspondingly arranged. When the first tube body 24 moves along the axial direction of the first housing 10, it will drive at least two second tube bodies 25 to move along the axial direction of the first housing 10, so that at least two first pulling assemblies 30 can pull all the first clamping arms of the valve clipper S1 to open or clamp at the same time. Furthermore, when the first pulling assembly 30 moves in the second tube 25 along the axial direction of the second tube 25, the corresponding first clamp arm on the valve clip S1 can be opened or clamped. By providing the first tube 24 and the second tube 25, it is convenient for the operator to operate simultaneously or individually, and in particular, it can be avoided that when one of the first pulling assemblies 30 is operated individually, the other first pulling assemblies 30 are affected.

[0105] Specifically, the first tube body 24 is arranged in the first shell 10 along the axial direction of the first shell 10, and at least two second tube bodies 25 are distributed at intervals along the circumference of the first tube body 24 to avoid mutual interference during operation, and at least two second tube bodies 25 are arranged tilted in the axial direction of the first tube body 24, which can not only reduce the spatial size of the control module 100, but also facilitate packaging, transportation and storage, and also facilitate the operator to perform traction operations. Among them, the tilt angle between the first tube body 24 and the second tube body 25 cannot be too large or too small, which is not conducive to the operator to perform good traction. Therefore, a reasonable setting of the tilt angle can further improve the operation efficiency. In one embodiment, the angle between the first tube body 24 and the second tube body 25 is an acute angle, and the opening is toward the proximal end of the first tube body 24.

[0106] In addition, the first tube body 24 and the second tube body 25 may be integrally formed, which may improve the structural strength and extend the overall service life of the control tube 20 .

[0107] Reference Figure 1 and Figure 2As shown, the first shell 10 further includes: at least two avoidance holes 12 and at least two protective covers 13, the at least two protective covers 13 are respectively arranged above the at least two avoidance holes 12, at least two second tubes 25 are respectively penetrated by the at least two avoidance holes 12, and the at least two second tubes 25 move in the at least two avoidance holes 12 driven by the first tube 24, and the protective cover 13 is selectively covered on the second tube 25. In this way, the number of avoidance holes 12, protective covers 13 and second tubes 25 is arranged one by one, and under the drive of the first tube 24, the second tube 25 can move in the avoidance hole 12 to ensure the movement track and movement stroke of the second tube 25.

[0108] Furthermore, the protective cover 13 is tiltedly arranged at the distal end of the avoidance hole 12, with the same tilt angle as the second tube body 25. When the second tube body 25 moves to the distal end of the avoidance hole 12, a portion of the second tube body 25 can fit with the protective cover 13, thereby effectively protecting the second tube body 25. In particular, when not in use or placed normally, the second tube body 25 is generally fitted with the protective cover 13, which can prevent the second tube body 25 from being damaged during transportation or assembly.

[0109] like Figure 2 and Figure 3 As shown, the first pulling assembly 30 includes: a first pulling member 31 and a first control member 32. The first pulling member 31 cooperates with a corresponding first clamping arm and is arranged in the first through hole 22. The first control member 32 is inserted in the first through hole 22 and is fixedly connected to the first pulling member 31. The first control member 32 selectively moves along the axial direction of the first through hole 22 in the first through hole 22 to pull the first pulling member 31, thereby driving the first clamping arm to open or clamp. In other words, the first pulling member 31 is connected to the first clamping arm, and the first pulling member 31 passes through the inner cavity of the first housing 10 and the inner cavity of the control tube 20, enters the first through hole 22, and is correspondingly connected to the first control member 32. During the process of implanting the valve clamp S1, the first clamp arm of the valve clamp S1 needs to be opened or clamped according to different situations, and needs to maintain a certain state. At this time, the first control component 32 can selectively move continuously or stop moving, so that the first clamp arm can be opened or clamped, and after opening or clamping, it can be maintained in a certain state, thereby effectively improving the stability and reliability of the control module 100 in controlling the implantation of the valve clamp S1.

[0110] The control module 100 further includes: a second pulling assembly 50, which includes: a second pulling member 51, a second control member 52 and a third tube 27. The third tube 27 is arranged on the first housing 10 and at least partially located outside the first housing 10. A second through hole 14 is arranged in the third tube 27 along the axial direction of the third tube 27. The second through hole 14 is communicated with the inner cavity of the first housing 10. The second pulling member 51 passes through the second through hole 14. The second control member 52 is inserted in the second through hole 14 and fixedly connected to the second pulling member 51. The second control member 52 selectively moves in the second through hole 14 along the axial direction of the second through hole 14 to pull the second pulling member 51. In this arrangement, the pulling and fixing effects of the second pulling member 51 can also be achieved by selectively moving the second control member 52 along the axial direction of the second through hole 14. And, the third tube body 27 is tilted in the axial direction of the first tube body 24, wherein the tilt angle of the third tube body 27 can be the same as or different from that of the second tube body 25, and a protective cover 13 is also provided on the first housing 10, and the protective cover 13 is provided on the third tube body 27. In this way, when not in use or placed, the protective cover 13 can effectively protect the third tube body 27 and prevent damage during transportation or assembly. In this embodiment, the second pulling member 51 cooperates with the locking tongue of the valve clamp S1. When the second pulling member 51 pulls the locking tongue, the transmission member of the valve clamp S1 is unlocked, and when the second pulling member 51 releases the locking tongue, the transmission member of the valve clamp S1 is locked. In addition, when the second control member 52 stops moving, the second pulling member 51 remains in the current state, so that the locking tongue remains in the current state. It can be understood that, as described above, in other embodiments not shown, when the second pulling assembly 50 is applied to other valve clamps, it can be used to control other control objects.

[0111] In particular, the structures of the protective covers 13 of at least two second tubes 25 are not completely the same, and a bracket is further provided at one end of the protective cover 13 of one second tube 25 adjacent to the third tube 27, which can effectively support the third tube 27, and the protective cover 13 of the third tube 27 can protect the third tube 27 together with the bracket to prevent it from breaking under the action of external force. At the same time, the bracket can also limit the movement of the second control member 52 along the axial direction of the second through hole 14 to prevent interference with the first shell 10.

[0112] In one embodiment, the first pull member 31 and the second pull member 51 may preferably be a high-modulus, low-shrinkage polymer wire. For example, ultra-high-strength polyethylene wire, which has excellent properties such as stable chemical properties, high mechanical strength, light weight, high thermal stability and good hygienic performance, can be used as the first pull member 31 and the second pull member 51. In addition, the first pull member 31 and the second pull member 51 can each be a polymer wire to achieve the pulling effect, and can be directly withdrawn after implantation, which is simple, efficient and easy to implement.

[0113] like Figure 3 to Figure 4 As shown, the first control member 32 and the second control member 52 are provided with a first limiting portion 321 in the circumferential part, the first control member 32 and the second control member 52 are provided with a avoiding portion 322 in the other circumferential part, and the second limiting portion 26 is provided in the inner side of the first through hole 22 and the inner side of the second through hole 14. In other words, the first control member 32 and the second control member 52 have the same structure. Taking the first control member 32 as an example, the first limiting portion 321 is provided on the two corresponding circumferential sides of the first control member 32, and the avoiding portion 322 is provided on the other two corresponding circumferential sides. The first control member 32 and the second tube body 25 can be locked or unlocked by selectively matching the first limiting portion 321 or the avoiding portion 322 of the first control member 32 with the second limiting portion 26 of the first through hole 22.

[0114] Specifically, when the first limit portion 321 and the second limit portion 26 are opposite to each other, the first limit portion 321 and the second limit portion 26 are limited and matched; when the avoidance portion 322 and the second limit portion 26 are opposite to each other, the first control member 32 can move axially along the first through hole 22 in the first through hole 22. In this way, when the first limiting portion 321 cooperates with the second limiting portion 26, the first limiting portion 321 is a slot and the second limiting portion 26 is a locking protrusion, so that the second limiting portion 26 can be stuck on the first limiting portion 321, so that the first control member 32 stops moving, thereby maintaining the first clamping arm of the valve clamp S1 in a certain state; or, when the avoidance portion 322 and the second limiting portion 26 are opposite to each other, the avoidance portion 322 and the second limiting portion 26 are staggered, that is, there is no interference between them, so that the first control member 32 is not restricted by the second limiting portion 26, so that the first control member 32 can move axially along the first through-hole 22, so that the first pulling member 31 pulls the first clamping arm of the valve clamp S1 to open or clamp.

[0115] Among them, the first control member 32 and the second control member 52 are both provided with a handle portion 323 at one end away from the first shell 10, so as to facilitate the operation of the first control member 32 and the second control member 52. In this way, by providing the handle portion 323, it is convenient for the operator to rotate the first control member 32 and the second control member 52 circumferentially during operation. In addition, the structural design of the handle portion 323 facilitates the operator to pull the first control member 32 and the second control member 52 in the axial direction, thereby realizing the selective axial movement of the first control member 32 and the second control member 52. In addition, the handle portion 323 cooperates with the protective cover 13 to limit the movement of the first control member 32 and the second control member 52.

[0116] In addition, the top ends of the first control member 32 and the second control member 52 facing away from the first housing 10 are both provided with threads, and correspondingly, the top ends of the first control member 32 and the second control member 52 are both provided with screw caps 28. The first control member 32 and the second control member 52 are both hollow structures with both ends penetrated. With such a configuration, after the first pulling member 31 and the second pulling member 51 respectively penetrate the first through hole 22 and the second through hole 14, they can further penetrate the first control member 32 and the second control member 52 and pass out from the top ends of the first control member 32 and the second control member 52. Through the matching connection of the threads and the screw cap 28, the first pulling member 31 and the second pulling member 51 are respectively fixed on the first control member 32 and the second control member 52, so that the pulling effect is achieved through the axial movement of the first control member 32 and the second control member 52. After the valve clip S1 is implanted, it is also convenient to remove the first pulling member 31 and the second pulling member 52 after releasing the thread matching.

[0117] In addition, the control module 100 further includes: a second adjusting member 60 and a pulling member 70. The second adjusting member 60 is disposed in the first housing 10 and is spaced apart from the first adjusting member 40. The second adjusting member 60 is located at the proximal end of the first housing 10 relative to the first adjusting member 40. The second adjusting member 60 and the pulling member 70 are in transmission connection, and can drive the pulling member 70 to move in the axial direction of the first housing 10. In this embodiment, one end of the pulling member 70 is connected to the transmission member of the valve clamp S1, for example, by threaded connection, and the other end extends into the inner cavity of the first housing 10 along the axial direction of the first housing 10, and is transmission-connected to the second adjusting member 60 after passing through the inner cavity of the first tube 24. When the transmission member is in the unlocked state, the pulling member 70 is driven by the second adjusting member 60 to move along the axial direction of the first housing 10, so that the pulling member 70 can drive the transmission member of the valve clamp S1 to move, thereby adjusting the opening or clamping of the second clamp arm of the valve clamp S1, and the first base of the valve clamp S1 is moved away from or close to the second base. It can be understood that, as described above, in other embodiments not shown, the traction member 70 can be used to control other control objects when applied to other valve clippers.

[0118] Specifically, the control module 100 also includes: a mounting sleeve 71, which is mounted on the traction member 70 and fixedly connected to the traction member 70, the mounting sleeve 71 is provided with an external thread, the second adjusting member 60 is provided with an internal thread, and the second adjusting member 60 is axially limited with the first shell 10. In this way, through the transmission cooperation of the external thread and the internal thread, when the second adjusting member 60 rotates circumferentially, the traction member 70 can move axially relative to the first shell 10 under the drive of the mounting sleeve 71.

[0119] Furthermore, at least a portion of the second adjusting member 60 is exposed relative to the first shell 10 , which makes it convenient for the operator to rotate the second adjusting member 60 .

[0120] like Figure 5 As shown, the control module 100 also includes: a clamping member 80. The clamping member 80 is arranged on the mounting sleeve 71 and selectively fixes the traction member 70. The clamping member 80 includes: a chuck nut 81, a chuck core 82 and a chuck shaft 83. The chuck core 82 of the clamping member 80 is a four-petal spring structure, which is a clamping structure that can be pressed to the center. The chuck shaft 83 is inserted on the mounting sleeve 71, and the chuck core 82 is inserted in the chuck shaft 83. The traction member 70 passes through the chuck shaft 83 and the chuck core 82 of the clamping member 80. The chuck nut 81 of the clamping member 80 is connected with the chuck shaft 83 of the clamping member 80 by threading, and the chuck core 81 of the clamping member 80 is pressed to the middle, and the traction member 70 is tightly held, thereby playing the role of fixing the traction member 70. That is, the traction member 70 is fixedly connected to the installation sleeve 71 so that the traction member 70 can move driven by the installation sleeve 71 .

[0121] The clamping member 80 and the mounting sleeve 71 also play a protective role for the traction member 70, which can prevent direct contact with the traction member 70, thereby preventing the traction member 70 from being misoperated, such as misrotating the traction member 70. When the traction member 70 needs to be rotated, the threaded engagement of the clamping nut 81 needs to be released so that the proximal end of the traction member 70 is exposed. At this time, the traction member 70 can be rotated to release the connection between the traction member 70 and the transmission member of the valve clip S1. At this time, the traction member 70 can be pulled out, and after the traction member 70 is pulled out, the dissociator can be separated from the valve clip S1.

[0122] Furthermore, a fixing hole 84 is provided on the clamp shaft 83 of the clamp 80, and the clamp 80 further comprises a fixing screw, which is threadedly matched with the fixing hole 84 and abuts against the traction member 70, so as to further prevent the traction member 70 from rotating arbitrarily. In this way, not only the clamp nut 81 needs to be released to expose the proximal end of the traction member 70, but also the abutment of the fixing screw on the traction member 70 needs to be released before the traction member 70 can be rotated.

[0123] According to the delivery system S2 of the second embodiment of the present invention, the delivery system S2 is used to deliver and implant the valve clip S1.

[0124] like Figure 6-Figure 10 As shown, the conveying system S2 includes: the control module 100, the conveying module 200 and the guiding module 400 of the above-mentioned embodiment.

[0125] Among them, Fig.10 As shown, the control module 100 also includes: a multi-lumen tube 90, a first pulling member 31 passing through the multi-lumen tube 90, and a valve clamp S1 disposed at the distal end of the multi-lumen tube 90. That is, the first pulling member 31 passes through the multi-lumen tube 90 and is correspondingly connected to the valve clamp S1 to achieve pulling of the first clamp arm. Similarly, the second pulling member 51 and the traction member 70 also pass through the multi-lumen tube 90 and are correspondingly connected to the valve clamp S1 to achieve unlocking and locking of the transmission member, as well as opening and clamping of the second clamp arm, thereby ensuring stable implantation and fixation of the valve clamp S1. Specifically, the traction member 70 passes through the center of the multi-lumen tube 90, there are two first pulling members 31, and the two first pulling members 31 are respectively disposed on both sides of the traction member 70, and there is one second pulling member 51. The multi-lumen tube 90 is provided with a plurality of chambers, including a first chamber 91, a second chamber 92 and a central chamber 93, which are respectively used to pass the first pulling member 31, the second pulling member 51 and the traction member 70, so that they are isolated from each other to avoid mutual interference.

[0126] Furthermore, the delivery module 200 is connected to the control module 100, and the delivery module 200 includes: a delivery sheath 210, and the multi-lumen tube 90 passes through the delivery sheath 210. In other words, the multi-lumen tube 90 is used to pass through the delivery sheath 210 to achieve the connection between the delivery module 200 and the control module 100. Furthermore, the guide module 400 is connected to the side of the delivery module 200 away from the control module 100, and the guide module 400 includes: a guide sheath 410 and an expansion tube 420, and any one of the delivery sheath 210 and the expansion tube 420 passes through the guide sheath 410. That is to say, the expansion tube 420 or the delivery sheath 210 can selectively pass through the guide sheath 410 according to different requirements, and the delivery module 200 and the guide module 400 are connected through the connector 500. When the multi-lumen tube 90 with the valve clamp S1 passes through the delivery sheath 210 and the delivery sheath 210 passes through the guide sheath 410, the control module 100, the delivery module 200 and the guide module 400 constitute the delivery system S2, so that the valve clamp S1 can be smoothly and accurately delivered to the mitral valve position for clamping.

[0127] like Figure 11-Figure 16As shown, the delivery module 200 and the guide module 400 both include a bending control assembly 220, through which the delivery sheath 210 or the guide sheath 410 can be bent to achieve a turn in the surgical pathway, thereby smoothly reaching the left atrium. Among them, the guide sheath 410 and the delivery sheath 210 can both be unidirectional bending sheaths.

[0128] Among them, the bending control assembly 220 includes: a second shell 230, a threaded tube 240, a third adjusting member 250, and a pull wire 260. The threaded tube 240 and the third adjusting member 250 are both arranged in the second shell 230, and the third adjusting member 250 is sleeved on the threaded tube 240. The third adjusting member 250 and the second shell 230 are axially limited to prevent the third adjusting member 250 from moving axially along the second shell 230. One end of the pull wire 260 is fixedly connected to the threaded tube 240, and the other end of the pull wire 260 is connected to the delivery sheath 210 or the guide sheath 410. A third threaded portion is provided on the inner side of the third adjusting member 250, and a fourth threaded portion 241 is provided on the outer side of the threaded tube 240. The third threaded portion and the fourth threaded portion 241 are threadedly matched to realize the axial movement of the threaded tube 240 along the second shell 230. In this way, through the threaded cooperation between the third adjusting member 250 and the threaded tube 240, the circumferential rotation of the third adjusting member 250 can be converted into the axial movement of the threaded tube 240. At this time, the threaded tube 240 will tighten the pull wire 260, and the pull wire 260 pulls the guide sheath 410 or the delivery sheath 210 to achieve bending adjustment, and the operation is simple and convenient, which can improve the work efficiency of the operator. Among them, at least part of the third adjusting member 250 is exposed relative to the second shell 230, which can facilitate the operator to perform the rotation operation. It can be understood that when the threaded tube 240 moves toward the proximal end along the axial direction of the second shell 230, the pull wire 260 is tightened to increase the bending degree of the guide sheath 410 or the delivery sheath 210, and when the threaded tube 240 moves toward the distal end along the axial direction of the second shell 230, the pull wire 260 is loosened to reduce the bending degree of the guide sheath 410 or the delivery sheath 210.

[0129] In addition, the bending control assembly 220 also includes: a wire tensioner 270, which is fixed to the threaded tube 240, and the pull wire 260 passes through the wire tensioner 270. In this configuration, the wire tensioner 270 tightens the wire 260, that is, the wire tensioner 260 is fixedly connected to the threaded tube 240 through the wire tensioner 270, so that the threaded tube 240 can drive the wire 260 when moving axially along the second shell 230, thereby bending the guide sheath 410 or the delivery sheath 210.

[0130] Specifically, Fig.14 and Fig.15As shown, the wire locker 270 includes: a main body 271, a pin shaft 272 and an elastic member 273. One end of the main body 271 is fixed to the threaded tube 240, and the other end is provided with a step portion 274. A conical hole 275 is opened on the main body 271, and the end with a larger aperture of the conical hole 275 is close to the step portion 274. The pin shaft 272 passes through the conical hole 275 of the main body 271 and selectively moves in the conical hole 275. The elastic member 273 is sleeved on the main body 271, and one end of the elastic member 273 abuts against the pin shaft 272, and the other end abuts against the step portion 274. With such arrangement, the pull wire 260 passes through the main body 271, and the pin shaft 272 moves to the end of the tapered hole 275 with a smaller aperture under the elastic force of the elastic member 273, thereby compressing the pull wire 260. When the threaded tube 240 moves axially along the second shell 230, the pin shaft 272 cooperates with the elastic member 273 to always compress the pull wire 260 in the moving direction of the pull wire 260, effectively preventing the pull wire 260 from slipping. In addition, fixing the pull wire 260 by the pull wire locker 270 is more convenient and adjustable, which is conducive to installation operations.

[0131] In addition, the bending control assembly 220 further includes: a connecting member 280 and an indicator 290, one end of the connecting member 280 is connected to the threaded tube 240, and the other end is connected to the indicator 290, and the indicator 290 selectively moves in the axial direction of the second housing 230. In this way, when the threaded tube 240 moves axially along the second housing 230, it will drive the indicator 290 and the connecting member 280 to move axially together, wherein the second housing 230 is provided with a window for the indicator 290 to be exposed, and the indicator 290 is provided with an indicator line, and a scale is provided at the window, which can display the moving distance of the pull wire 260, thereby indicating the bending angle of the guide sheath 410 or the delivery sheath 210. Alternatively, the moving distance can be converted into the bending angle, and the scale directly displays the angle value. Such a structural design greatly facilitates the operator to judge the bending control condition of the distal end of the guide sheath 410 or the delivery sheath 210 from the indication of the indicator 290 during the operation.

[0132] In addition, the bending control assembly 220 also includes: a guide tube 300, the guide tube 300 is arranged in the threaded tube 240, the outer side of the guide tube 300 is provided with a first sliding part, the inner side of the threaded tube 240 is provided with a second sliding part 242, the first sliding part is one of a slide groove and a slider, the second sliding part 242 is another of the slide groove and the slider, and the slide groove and the slider are slidably connected. In other words, through the cooperation of the first sliding part and the second sliding part 242, the threaded tube 240 can slide relatively along the guide tube 300, which can reduce the running friction and improve the sliding efficiency. Moreover, it can also play a guiding role in the movement of the threaded tube 240. Of course, it can also be the cooperation of the ball and the slide groove, not limited to this structure. In addition, a travel limit block 310 is provided on the second housing 230, which is used to limit the sliding travel of the threaded tube 240 to ensure that the bending angle of the guide sheath 410 or the conveying sheath 210 is controlled within a certain range. Furthermore, the guide tube 300 is a hollow structure with two ends passing through, so as to allow the delivery sheath 210 or the guide sheath 410 to pass through.

[0133] In addition, the lower end of the main body 271 of the wire tensioner 270 is designed to be square, which is adapted to the square groove 243 of the threaded tube 240. When the threaded tube 240 drives the wire tensioner 270 to move, the wire tensioner 270 is prevented from rotating and interfering with other parts. It can be understood that the lower end of the main body 271 can also be designed to be other non-cylindrical shapes, and the groove 243 is correspondingly designed to be other non-circular grooves, as long as the wire tensioner 270 is prevented from rotating. In addition, the end of the threaded tube 240 is provided with a card slot 244, which is engaged with the connector 280 to achieve a stable connection between the threaded tube 240 and the connector 280, thereby ensuring that the indicator line of the indicator 290 can accurately display the moving distance of the wire 260.

[0134] In addition, the bending control assembly 220 further includes: a proximal end cover arranged at the proximal end of the second shell 230 , a distal end cover arranged at the distal end of the second shell 230 , and a hemostatic valve arranged in the proximal end of the second shell 230 .

[0135] like Fig.17As shown, in order to achieve the purpose of adjusting the bending of the bending control component 220, the bending control angle of the guide sheath 410 can be 0-120°, and a composite sheath with controllable bending can be selected. Among them, the inner layer of the composite sheath is a polymer layer with good lubricity, which can make the conveying sheath 210 or the expansion tube 420 pass smoothly, and polytetrafluoroethylene (PTFE) is preferably used; the middle layer is a metal layer, which can be a braided metal wire or a cut metal tube to enhance the strength of the sheath and have a certain flexibility; the outer layer is a polymer layer, which adopts a segmented hardness design, wherein the C section is the first main section, and a material with high hardness is selected, the B section is the first bending control section, and a soft material is selected, and the A section is the first end section, and a material with high hardness is selected. The pull wire 260 is located between the middle layer and the outer layer, and a pull wire ring is provided between the A section and the B section, and the pull wire ring is located between the middle layer and the outer layer, and the pull wire 260 is connected to the pull wire ring. When the pull wire 260 is pulled at the proximal end of the sheath tube, the pull wire 260 drives the guide sheath 410 to bend toward the side of the pull wire 260. Due to the segmented hardness design, only the B segment bends, thereby achieving the design purpose.

[0136] like Fig.18 As shown, the structural design of the delivery sheath 210 is similar to that of the guide sheath 410, except that the outer layer of the delivery sheath 210 is designed in sections. According to the use requirements, the A section of the delivery sheath 210 is the second end section, and a material with high hardness is selected. The B section is the second bending control section extending out of the guide sheath 410, and the bending control angle is 0-120°. The B section is selected with a soft material. The C section is designed as a compliant section. In the final state, the C section is located in the first bending control section of the guide sheath 410. The hardness of the material selected for the C section is less than or equal to the hardness of the second bending control section of the delivery sheath 210, and the length of the C section is greater than the length of the first bending control section of the guide sheath 410. With such a design, after the delivery sheath 210 extends out of the guide sheath 410 and the distal end is controlled to bend, it can also be pushed forward and backward to adjust the position of the distal valve clip S1 without affecting the distal bending shape of the guide sheath 410, so as to improve the stability of the guide sheath 410. In addition, the D section of the delivery sheath 210 is the second main section, and a material with high hardness is selected.

[0137] Therefore, the delivery module 200 and the guide module 400 only need to rotate the third adjustment part 250 to achieve the bending control of the delivery sheath 210 and the guide sheath 410, as well as rotate and move the guide sheath 410 and the delivery sheath 210 back and forth, so as to realize the overall rotation or movement of the valve clamp S1, and finally the valve clamp S1 can be passed through the inferior vena cava, right atrium, atrial septum, left atrium, and finally to the mitral valve position, thereby effectively simplifying the surgical operation and shortening the operator's learning curve.

[0138] Refer to the following Figure 19-Figure 23 The process of delivering and implanting the valve clipper S1 by the delivery system S2 in the embodiment of the present invention is described as follows:

[0139] Implantation process 1: Fig.19 As shown, the operator inserts the guide wire 430 into the heart through the Seldinger puncture technique and performs an atrial septal puncture technique. The dilator tube 420 is inserted into the guide sheath 410, and the dilator tube 420 is sleeved on the guide wire 430. In this way, the guide sheath 410 and the dilator tube 420 enter the human body along the guide wire 430. By manipulating the third adjustment member 250 of the guide module 400, the pull wire 260 controls the first bending control section at the distal end of the guide sheath 410 to bend and deflect, so that the guide sheath 410 enters the right atrium and passes through the atrial septum along the guide wire 430 into the left atrium. Then the dilator tube 420 and the guide wire 430 are withdrawn, and the guide sheath 410 is retained in the human body.

[0140] Implantation process 2: Fig. 20 and Fig.21 As shown, the connector 500 connects the control module 100 and the delivery module 200 equipped with the valve clamp S1 with the guide sheath 410, wherein the delivery sheath 210 enters the left atrium along the guide sheath 410, and the multi-lumen tube 90 located in the delivery sheath 210 and loaded with the valve clamp S1 enters the left atrium along the delivery sheath 210, and after the valve clamp S1 is exposed to a certain distance from the distal end of the guide sheath 410, the pull wire 260 is used to control the bending of the second bending control section at the distal end of the delivery sheath 210, so that the valve clamp S1 points to the position of the mitral valve annulus.

[0141] Implantation process three: Fig.21 As shown, the bending control assembly 220 of the delivery module 200 is rotated and moved forward and backward, driving the delivery sheath 210 that has been controlled to bend to rotate and move, so as to adjust the position of the valve clip S1 so that it is perpendicular to the mitral valve annulus and aligned with the lesion position.

[0142] Implantation process 4: Fig. 22 As shown, the first adjusting member 40, the second adjusting member 60, the first control member 32 and the second control member 52 of the operating control module 100 are used to adjust the opening degree of the clamping arms of the valve clamper S1, so that the opening degree of the first clamping arm and the second clamping arm meets the clamping requirement, and the first shell 10 is moved to move the multi-lumen tube 90, thereby driving the valve clamper S1 to move as a whole, so that the position of the valve clamper S1 meets the clamping requirement.

[0143] Implantation process five: Fig.23 As shown, the first adjusting member 40, the second adjusting member 60, the first control member 32 and the second control member 52 of the operating control module 100 enable the valve clamp S1 to capture the valve leaflet. After the valve clamp S1 is placed in place, the first pulling member 31, the second pulling member 51 and the traction member 70 are pulled out to release the valve clamp S1. Finally, the delivery system S2 is withdrawn from the human body to end use.

[0144] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0145] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "illustrative embodiments", "examples", "specific examples", or "some examples" means that the specific features, structures, materials, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example.

[0146] Although the embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the claims and their equivalents.

Claims

1. A control module, which controls the implantation of a valve clamp, wherein the valve clamp comprises at least two first clamp arms, characterized in that: include: a first shell; a control tube, wherein the control tube is partially disposed in the first shell and partially disposed outside the first shell, and at least two first through holes are disposed on the portion of the control tube located outside the first shell; At least two first pulling components, at least two of the first pulling components are respectively inserted into at least two of the first through-holes and are matched and connected with at least two of the first clamp arms in a one-to-one correspondence, the first pulling component comprises: a first pulling member and a first control member, the first pulling member is inserted into the first through-hole and is fixedly connected to the first pulling member, the first control member selectively moves in the first through-hole along the axial direction of the first through-hole to pull the first pulling member; The control tube selectively moves axially along the first housing in the first housing to pull all the first clamp arms, and the first pulling assembly selectively moves axially along the first through-hole in the first through-hole to pull a corresponding one of the first clamp arms.

2. The control module according to claim 1, characterized in that: Also includes: A first adjusting member, wherein the first adjusting member is disposed in the first housing and is in driving connection with a portion of the control tube located in the first housing to drive the control tube to move in an axial direction of the first housing; Wherein, at least a portion of the first adjusting member is exposed relative to the first shell.

3. The control module according to claim 2, characterized in that: A first threaded portion is provided on the inner side of the first adjusting member, a second threaded portion is provided on the outer side of the portion of the control tube located in the first shell, the first threaded portion and the first threaded portion are meshed for transmission, and the first adjusting member is axially limitedly matched with the first shell.

4. The control module according to claim 1, characterized in that: The control module also includes: a second pulling component, the second pulling component includes: a second pulling piece, a second control piece and a third tube body, the third tube body is arranged on the first shell and a second through hole is arranged in the third tube body, the second pulling piece passes through the second through hole, the second control piece is inserted into the second through hole and fixedly connected to the second pulling piece, and the second control piece selectively moves along the axial direction of the second through hole in the second through hole to pull the second pulling piece.

5. The control module according to claim 4, characterized in that: A first limiting portion is provided at a circumferential portion of the first control member and the second control member, a avoiding portion is provided at another circumferential portion of the first control member and the second control member, and a second limiting portion is provided at an inner side of the first through hole and an inner side of the second through hole; When the first limiting portion and the second limiting portion are opposite to each other, the first limiting portion and the second limiting portion are limited and matched; when the avoidance portion and the second limiting portion are opposite to each other, the first control member moves in the first through-hole along the axial direction of the first through-hole, or the second control member moves in the second through-hole along the axial direction of the second through-hole.

6. The control module according to claim 2, characterized in that: Also includes: A second adjusting member and a pulling member, wherein the second adjusting member is arranged on the first housing and spaced apart from the first adjusting member, and the second adjusting member and the pulling member are transmission-connected to selectively drive the pulling member to move in the axial direction of the first housing.

7. A delivery system for delivering and implanting the valve clip, characterized in that: include: The control module according to any one of claims 1 to 6, further comprising: a multi-lumen tube, wherein the first pulling member passes through the multi-lumen tube, and the valve clip is disposed at a distal end of the multi-lumen tube; A delivery module, the delivery module is connected to the control module, and the delivery module comprises: a delivery sheath, the multi-lumen tube passes through the delivery sheath; A guide module, wherein the guide module is connected to a side of the delivery module away from the control module, and the guide module comprises: a guide sheath and an expansion tube, and any one of the delivery sheath and the expansion tube passes through the guide sheath.

8. The conveying system according to claim 7, characterized in that The conveying module and the guide module both include: a bending control assembly, and the bending control assembly includes: a second shell, a threaded tube, a third adjusting member, and a pull wire. The threaded tube and the third adjusting member are both arranged in the second shell, and the third adjusting member is sleeved on the threaded tube and cooperates with the axial limiting position of the second shell. One end of the pull wire is fixedly connected to the threaded tube, and the other end of the pull wire is connected to the conveying sheath or the guide sheath. A third threaded portion is provided on the inner side of the third adjusting member, and a fourth threaded portion is provided on the outer side of the threaded tube. The third threaded portion and the fourth threaded portion are threadedly cooperated to realize the axial movement of the threaded tube along the second shell.

9. The conveying system according to claim 8, characterized in that The bending control assembly also includes: a wire locking device, which is fixed to the threaded tube and through which the wire is passed.

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