CN116407344A

CN116407344A - Cardiac valve suture device

Info

Publication number: CN116407344A
Application number: CN202111663791.2A
Authority: CN
Inventors: 张庭超; 严新火; 江巍
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2023-07-11

Abstract

The application relates to a heart valve suture device, a handle assembly comprises a rotating mechanism, the rotating mechanism comprises a rotating shaft, a rotating piece and a sealing piece, the rotating piece is fixedly connected with a tube body in a sealing way, the rotating piece is fixedly connected with the rotating shaft in a sealing way, a push rod channel is arranged on the rotating shaft along the axial direction, a push rod cavity is arranged on the tube body along the axial direction, the push rod channel is communicated with the push rod cavity, a clamping assembly comprises a clamping push rod and a distal chuck arranged at the distal end of the clamping push rod, and the clamping push rod is movably arranged in the push rod cavity and the push rod channel in a penetrating way; after the clamping push rod passes through the sealing element and the push rod channel, the sealing element blocks the communication between the push rod channel and the push rod cavity, and the rotating element is provided with an exhaust connector communicated with the push rod cavity, wherein the exhaust connector is used for communicating an exhaust pipe. The exhaust joint communicated with the push rod cavity is directly arranged on the rotating piece, the structure is simple, an independent exhaust structure is not required to be additionally arranged, the exhaust structure is prevented from occupying the inner space of the shell of the handle assembly, the whole volume of the handle can be reduced, and the operation of holding by an operator is facilitated.

Description

Cardiac valve suture device

Technical Field

The present application relates to the field of interventional medical devices, and in particular to a heart valve suture device.

Background

Heart valves such as mitral and tricuspid valves are unidirectional "valves" between the atrium and ventricle, ensuring that blood flows from the atrium to the ventricle. When the chordae of the heart valve are diseased or broken, the valve is closed incompletely to cause blood reflux, and the heart valve can be treated by chordae repair. The chordae tendineae repair basically does not change the physiological anatomy structure, can truly realize the physiological repair, has little influence on the blood dynamics of the heart valve, and keeps the possibility of performing secondary intervention in the later period of the valve.

In recent years, the treatment of mitral regurgitation by minimally invasive interventional implantation of artificial chordae has become a focus of research. The heart valve suture device which is inserted by the catheter in a minimally invasive way generally needs to be subjected to exhaust treatment before being inserted into a human body, so that on one hand, air which is remained in the instrument is prevented from entering the human body and entering a venous system along with the blood circulation of the human body to cause air embolism; on the other hand, because the blood in the human body has a certain pressure, if the space occupied by the air in the heart valve suture device is large, a large amount of blood can enter the space, so that the blood in the human body is lost. However, in the existing heart valve suture device, an independent exhaust structure is arranged and sleeved on the rotating shaft of the handle, so that the exhaust structure is complex, the internal space of the handle shell is occupied, the whole volume of the handle is increased, and the operation difficulty of an operator is increased.

Disclosure of Invention

The application provides a heart valve suture device to solve the technical problem that needs to set up independent exhaust structure and occupy the interior space of handle casing among the current heart valve suture device.

The application provides a heart valve suture device, including handle assembly, body and centre gripping subassembly. The handle assembly includes a rotation mechanism including a rotation shaft, a rotation member, and a sealing member. The distal end of the rotating member is fixedly connected with the proximal end of the tube body in a sealing manner, and the proximal end of the rotating member is fixedly connected with the distal end of the rotating shaft in a sealing manner. The rotating shaft is axially provided with a push rod channel, the pipe body is axially provided with a push rod cavity, and the push rod channel is communicated with the push rod cavity. The clamping assembly comprises a clamping push rod and a distal chuck arranged at the distal end of the clamping push rod, and the clamping push rod is movably arranged in the push rod cavity and the push rod channel in a penetrating manner. After the clamping push rod passes through the sealing element and the push rod channel, the sealing element blocks the communication between the push rod channel and the push rod cavity, and the rotating element is provided with an exhaust connector communicated with the push rod cavity, wherein the exhaust connector is used for communicating an exhaust pipe.

Compared with the prior art, the technical scheme provided by the embodiment of the application has the following advantages:

in the heart valve suture device provided by the embodiment of the application, the rotating piece is directly provided with the exhaust connector communicated with the push rod cavity, and the exhaust connector is communicated with the exhaust pipe and then can be filled with liquid to exhaust the push rod cavity of the tube body. Like this, utilize the rotating member of connecting pipe body and rotation axis to exhaust, simple structure need not to set up independent exhaust structure additionally, avoids exhaust structure to occupy the inner space of the casing of handle subassembly, can reduce the whole volume of handle subassembly to be favorable to the operation of operation person's gripping.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the application and together with the description, serve to explain the principles of the application.

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required to be used in the description of the embodiments or the prior art will be briefly described below, and it will be obvious to those skilled in the art that other drawings can be obtained from these drawings without inventive effort.

FIGS. 1 and 2 are schematic illustrations of a heart valve suture device in various states, respectively, in accordance with one embodiment of the present application;

FIG. 3 is a cross-sectional view of the A-A plane of FIG. 1;

FIG. 4 is a cross-sectional view of the B-B plane of FIG. 2;

FIG. 5 is an enlarged view of a portion of region C1 of FIG. 4;

FIG. 6 is an exploded view of FIG. 1;

FIG. 7 is a schematic structural view of a suture assembly;

FIGS. 8 and 9 are schematic structural views of an adjustable elbow;

FIG. 10 is a schematic structural view of a traction member;

FIG. 11 is a schematic view of a clamping assembly;

FIG. 12 is a schematic view of a portion of the structure of an adjustable elbow;

FIG. 13 is a cross-sectional view of FIG. 8;

FIG. 14 is a schematic view of a support assembly;

FIG. 15 is a schematic view of the handle assembly with a portion of the housing removed;

FIG. 16 is an exploded view of the handle assembly;

FIGS. 17 and 18 are schematic views of the rotary joint at different angles of view;

FIG. 19 is a schematic view of the structure of the rotary member;

fig. 20 to 22 are schematic structural views of the rotary shaft;

FIG. 23 is a partial exploded view of the rotary mechanism;

FIG. 24 is a schematic view of a mandrel;

FIG. 25 is a schematic diagram of a structure of a tuning valve;

FIG. 26 is a schematic view of the structure of the connecting member;

FIG. 27 is an exterior view of the handle assembly;

FIGS. 28 to 32 are schematic structural views of the probe assembly;

fig. 33-36 are schematic views of a heart valve suture device in a process of implanting sutures at the leaflets.

Detailed Description

For the purposes of making the objects, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are within the scope of the present application based on the embodiments herein.

In the description of the present application, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device, and radial refers to a direction perpendicular to the axial direction. It is noted that the term "end" as used in the terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc., is not limited to a tip, end point or end wall, but includes a location extending an axial distance and/or a radial distance from the tip, end point or end wall to which the tip, end point or end wall pertains. The foregoing definitions are provided for convenience of description and are not to be construed as limiting the present application.

Referring to fig. 1 to 6 and 31, a heart valve suture device 1 according to an embodiment of the present application includes a handle assembly 11, a tube 12, and a clamping assembly 13. The handle assembly 11 includes a rotation mechanism 111, and the rotation mechanism 111 includes a rotation shaft 1111, a rotation member 1112, and a sealing member 1113. The distal end of the rotary member 1112 is sealingly and fixedly connected to the proximal end of the tube 12, and the proximal end of the rotary member 1112 is sealingly and fixedly connected to the distal end of the rotary shaft 1111. The rotary shaft 1111 is provided with a push rod passage 1111c in the axial direction H, and the pipe body 12 is provided with a push rod chamber 120 in the axial direction H, the push rod passage 1111c communicating with the push rod chamber 120. The clamping assembly 13 includes a clamping pushrod 131 and a distal chuck 132 disposed at a distal end of the clamping pushrod 131, wherein the clamping pushrod 131 is movably disposed in the pushrod chamber 120 and the pushrod channel 1111 c. After the clamping pushrod 131 passes through the sealing member 1113 and the pushrod passage 1111c, the sealing member 1113 blocks communication between the pushrod passage 1111c and the pushrod chamber 120, and the rotating member 1112 is provided with an exhaust connector 11120 communicating with the pushrod chamber 120, the exhaust connector 11120 being adapted to communicate with an exhaust pipe.

In the heart valve suture device 1 of the embodiment of the present application, the rotating member 1112 is directly provided with the exhaust joint 11120 communicated with the push rod cavity 120, and the exhaust joint 11120 is communicated with the exhaust pipe and then can be filled with liquid to exhaust the push rod cavity 120 of the pipe 12. Thus, the rotary piece 1112 of the connecting pipe body 12 and the rotary shaft 1111 is utilized to exhaust, the structure is simple, an independent exhaust structure is not required to be additionally arranged, the exhaust structure is prevented from occupying the inner space of the shell 110 of the handle assembly 11, the whole volume of the handle assembly 11 can be reduced, and the holding operation of an operator is facilitated.

It is understood that the exhaust fitting 11120 on the rotary member 1112 may be connected to an exhaust pipe. Specifically, the exhaust joint 11120 is provided with an exhaust passage 11121 along its center axis, and a connection groove 11122 is provided around the exhaust passage 11121. The pipe wall at one end of the exhaust pipe is penetrated in the connecting groove 11122, so that the pipe cavity of the exhaust pipe is communicated with the exhaust channel 11121 and is not easy to leak. The lumen of the exhaust pipe communicates with the exhaust passage 11121, and the exhaust passage 11121 communicates with the lumen of the tubular body 12 (e.g., the pushrod chamber 120). The tail end of the exhaust pipe can be provided with an exhaust valve, such as a three-way valve, so as to control the on-off of the exhaust pipe. Before the heart valve suture device 1 is introduced into the human body, it is necessary to vent the lumen of the tube 12 of gas. The exhaust valve is opened to fill liquid such as normal saline or heparin from the exhaust pipe, and the liquid enters the lumen of the pipe body 12 through the exhaust pipe and the exhaust joint 11120, so that air in the lumen of the pipe body 12 is discharged from the far end, the residual air in the lumen of the pipe body 12 is slightly reduced, and the occurrence rate of air embolism and blood loss is greatly reduced.

The seal 1113 is located proximal to the communication of the exhaust fitting 11120 with the push rod lumen 120 (i.e., the lumen of the tube 12), avoiding the seal 1113 from blocking communication of the exhaust fitting 11120 with the push rod lumen 120 from venting. The seal 1113 may be a flexible gasket made of one of silicone, rubber, and graphite. Thus, the sealing member 1113 may be sealingly connected to the rotary member 1112, the rotary shaft 1111, or an intermediate member connecting the rotary member 1112 and the rotary shaft 1111 by way of adhesive bonding. Of course, the sealing member 1113 may be connected to the rotating member 1112, the rotating shaft 1111 or an intermediate member connecting the rotating member 1112 and the rotating shaft 1111 in an interference fit or extrusion manner without any gap, so as to achieve a sealing effect. The seal 1113 is provided with a through hole, and the through hole is substantially closed in a natural state. When the elongated member such as the clamping pushrod 131 is installed, the clamping pushrod 131 passes through the through hole of the sealing member 1113, and the hole wall of the through hole is tightly attached to the outer surface of the clamping pushrod 131, so that the sealing effect is achieved. The through hole is substantially closed in a natural state, that is, when the clamping pushrod 131 does not pass through the through hole, the through hole is substantially closed.

The heart valve suture device 1 of the present application may be used for interventional procedures by implanting sutures on the leaflets of the mitral or tricuspid valve via the apex path. Sutures may be used as an alternative to diseased or broken chordae tendineae within the patient's heart; or a plurality of sutures are fixed with each other to realize the edge-to-edge repair of the heart valve (such as mitral valve and tricuspid valve). The following description exemplifies a suture as an artificial tendon, but it should be understood that the description is given by way of example only and not limitation of the present application, and that modifications or improvements based on the teachings of the present application are within the scope of the present application.

Referring to fig. 6 and 7, heart valve suture device 1 may include a handle assembly 11, a tube 12, a clamp assembly 13, a suture assembly 14, a puncture assembly 17, a support assembly 15, and a probe assembly 16. Wherein the tube 12 is used to deliver the clamping assembly 13 to a predetermined location near the valve; the clamping assembly 13 is used for clamping the valve leaflets of the valve; the supporting component 15 is used for supporting the lower surface of the valve leaflet, and the auxiliary clamping component 13 clamps the valve leaflet; the detection component 16 is used for detecting whether the clamping component 13 clamps the valve leaflet of the valve or not and the clamping effect on the valve leaflet; the puncture assembly 17 is used to puncture the leaflet and connect with the suture 141 after the clamping assembly 13 clamps the leaflet to implant the suture 141 on the leaflet of the mitral or tricuspid valve. Of course, the heart valve suture device 1 may also omit the support assembly 15 or the detection assembly 16, or omit the support assembly 15 and the detection assembly 16.

Correspondingly, the tube body 12 is provided with a plurality of lumens along the axial direction, and the number of the lumens can be set according to the number of the elongated members penetrating into the tube body, which is not particularly limited in this application. Such as holding pushrod 131, piercing needle 171 of piercing assembly 17, support arm 151 of support assembly 15, probe 161 of probing assembly 16, etc. Each lumen of the tube body 12 communicates with the exhaust fitting 11120 to exhaust the gas in the lumen. The rotating shaft 1111 is provided with a plurality of passages corresponding to each other in the axial direction, and the sealing member 1113 is provided with a plurality of through holes corresponding to each other for each elongate member to pass through. After each of the elongated members passes through the corresponding through hole of the sealing member 1113, the hole wall of each through hole is closely attached to the outer surface of each of the elongated members, so as to achieve a sealing effect, so that the sealing member 1113 can block the communication between the channels of the rotating shaft 1111 and the lumens of the tube 12, and further can exhaust the lumens of the tube 12 through the exhaust joint 11120.

Referring to fig. 8-10, the distal portion of the tube 12 is bendable, and in particular, the tube 12 includes a main section 1211 and an adjustable bend section 1212 disposed at the distal end of the main section 1211 along the axial direction H. The adjustable bending section 1212 can be welded and fixed with the main body section 1211, and the hardness of the tube body of the adjustable bending section 1212 is smaller than that of the main body section 1211, so that the adjustable bending section 1212 mainly plays a role in bending. The length of adjustable curved segment 1212 may be 20-30 mm and the range of the angle of curvature of adjustable curved segment 1212 may be 0-30 degrees. The heart valve suture device 1 further comprises a pulling member 122, the pulling member 122 being connected to the adjustable curved segment 1212, the pulling member 122 being adapted to control the bending or restoring of the adjustable curved segment 1212. The pulling member 122 may include two pulling wires 1221 and an anchor ring 1222 disposed at a distal end of the pulling wires 1221. An anchor ring 1222 is connected to adjustable bend segment 1212, preferably anchor ring 1222 is coaxial with adjustable bend segment 1212. Specifically, the anchor ring 1222 may be welded or adhesively secured to the adjustable bend segment 1212. Of course, the anchor ring 1222 may be omitted from the pull member 122, and the distal end of the pull wire 1221 fixedly attached directly to the adjustable bend 1212. The number of the traction wires 1221 may be one. It can be understood that the pipe body can also be a straight pipe, and the traction piece is not required to be arranged for bending adjustment.

The lumen of the tube 12 further includes two pulling lumens 1201, with openings at both the proximal and distal ends of the pulling lumens 1201, wherein the proximal opening is a wire exit orifice 1214. Two traction cavities 1201 are provided near the side wall of the tube body 12, and two traction wires 1221 are movably installed in the two traction cavities 1201, respectively, and can pass out from the wire outlet hole 1214. The pull wire 1221 is fixedly connected to the adjustable curved section 1212 by an anchor ring 1222, and pulling the pull wire 1221 bends the adjustable curved section 1212 or returns the adjustable curved section 1212 to a flat state after the tension on the pull wire 1221 is released. The traction wire 1221 may be a metal wire such as stainless steel, tungsten alloy, cobalt-chromium alloy or nickel-titanium alloy, or a wire made of a polymer material having a certain strength. It should be noted that the traction chamber 1201 also communicates with the exhaust joint 11120 to facilitate the exhaust of the gas in the traction chamber 1201.

Referring to fig. 1, 2, 11 and 12, the clamping assembly 13 further includes a proximal collet 133 that cooperates with the distal collet 132 to clamp the leaflet. In the illustrated example, a distal collet 132 is provided at the distal end of the gripping pushrod 131, with the distal wall of the tube 12 acting as a proximal collet 133, and the lumen of the tube 12, such as the pushrod lumen 120, extends through the proximal and distal walls of the tube 12. The clamping assembly 13 comprises two clamping push rods 131, correspondingly, the tube body 12 is provided with two push rod cavities 120, the two clamping push rods 131 are respectively movably arranged in the two push rod cavities 120 in a penetrating mode, and the opening and closing of the distal clamping head 132 and the proximal clamping head 133 can be controlled through the axial movement of the clamping push rods 131.

In other examples, a separate proximal collet 133 may be provided, the proximal collet 133 being provided at the distal end of the tube body 12, wherein the proximal collet 133 may be fusion-secured to the distal wall of the adjustable curved section 1212 of the tube body 12 to form a unitary body with the tube body 12. Because the tube body 12 is provided with a plurality of lumens, the proximal clamp 133 is correspondingly provided with a plurality of through holes, and the through holes are communicated with the plurality of lumens in a one-to-one correspondence.

The specific structure of the heart valve suture device 1 will be described below by taking the distal wall of the tube 12 as the proximal clip 133.

Referring to fig. 13, the heart valve suture device 1 is provided with a guide wire channel 1202 along an axial direction, the guide wire channel 1202 penetrating the tube 12 and the distal clip 132, the guide wire channel 1202 being for threading a guide wire. In this way, after the guidewire enters the ventricle through the valve along the apex puncture and reaches the left atrium, the guidewire may be passed through the guidewire channel 1202 of the heart valve suture device 1 to guide the heart valve suture device 1 through the valve leaflets, improving the safety of the heart valve suture device 1.

Referring to fig. 7, suture assembly 14 includes a suture 141 and a sleeve 142 coupled to suture 141. Suture 141 is flexible, with either one end of suture 141 being attached to sleeve 142, or both ends of suture 141 being attached to sleeve 142, sleeve 142 being adapted to be attached to needle 171 of piercing assembly 17. The number of the stitches 141 may be one, two or more. One end of suture 141 is secured to the leaflet and the other end may be secured to the ventricular wall or papillary muscles, etc., to replace diseased chordae tendineae and maintain tension between the leaflet and the ventricular wall. The material of the suture 141 may be a polymer material compatible with the human body, a softer metal material, or the like, and is preferably a polymer material.

In the illustrated example, a sleeve 142 is provided at both ends of the suture 141. Referring to fig. 11 and 12, the tube 12 is provided with a suture cavity 1203 along an axial direction, the distal collet 132 is provided with a suture receiving cavity 1321 in communication with the suture cavity 1203, and two sleeve cavities 1322 in axial communication with the suture receiving cavity 1321. Two sleeves 142 are received in sleeve cavities 1322 and then sutures 141 are threaded through suture receiving cavities 1321 and then threaded into suture cavities 1203. The proximal end of suture cavity 1203 may be closed to prevent contamination of suture 141 from being exposed from tube 12. Suture cavity 1203 may be in radial communication with one of the pusher cavities 120, i.e., suture cavity 1203 may be in indirect communication with a vent fitting 11120, to facilitate venting of gas from suture cavity 1203. In other examples, suture cavity 1203 may be provided in clamping pushrod 131 in communication with suture receiving cavity 1321 of distal collet 132.

Referring to fig. 6 and 12, the penetrating assembly 17 includes a penetrating needle 171, the penetrating needle 171 movably mounted in the tube 12, and the penetrating needle 171 for penetrating the valve leaflet to connect with the sleeve 142 of the suture assembly 14. The lumen of the tube body 12 comprises a puncture cavity 1204, i.e. the tube body 12 is provided with a puncture cavity 1204 along the axial direction, the puncture cavity 1204 penetrates through the proximal end wall and the distal end wall of the tube body 12, and the puncture needle 171 is movably arranged in the puncture cavity 1204. In the illustrated example, the puncture assembly 17 includes two puncture needles 171, and the two puncture needles 171 are arranged side by side; the tube body 12 is correspondingly provided with two puncture cavities 1204, and two sleeve cavities 1322 of the distal chuck 132 respectively correspond to the two puncture cavities 1204; two puncture needles 171 are respectively movably arranged in the two puncture cavities 1204. After the operator controls the puncture needle 171 to puncture the valve leaflet, the puncture needle 171 can be connected with the sleeve 142 of the suture 141, and the puncture needle 171 and the suture 141 form stable and reliable indirect connection through the sleeve 142, so that the suture 141 is not easy to separate from the puncture needle 171, the operator withdraws the puncture needle 171, and can pull the sleeve 142 and the suture 141 to penetrate the valve leaflet, and the suture 141 can be conveniently and rapidly pulled to the preset position of the ventricular wall or the mastoid muscle.

The puncture chamber 1204 of the tube body 12 communicates with the exhaust joint 11120, the rotation shaft 1111 is provided with a puncture passage 1111d (see fig. 22) communicating with the puncture chamber 1204 in the axial direction H, and after the puncture needle 171 passes through the seal 1113 and the puncture passage 1111d, the seal 1113 blocks the communication between the puncture passage 1111d and the puncture chamber 1204, so that the gas in the puncture chamber 1204 is exhausted through the exhaust joint 11120.

Referring to fig. 14 and 12, the support assembly 15 includes a support arm 151 and a support member 152 disposed at a distal end of the support arm 151, the support arm 151 movably mounted in the tube 12, the support arm 151 for pushing the support member 152 out of the distal end of the tube 12, and the support member 152 for supporting the valve leaflet. Specifically, the lumen of the tube body 12 includes a support arm lumen 1205, that is, the tube body 12 is provided with the support arm lumen 1205 along the axial direction H, the distal end of the support arm lumen 1205 is deviated from the axial direction H, the distal outlet thereof is opened at the side wall of the tube body 12, and the proximal end thereof penetrates the proximal end wall of the tube body 12. The support arm 151 is movably mounted in the support arm cavity 1205, and the support member 152 is accommodated in the support arm cavity 1205, and the support member 152 is pushed by the support arm 151 to penetrate out of the distal end outlet of the support arm cavity 1205, so as to support the lower surface of the valve leaflet, stabilize the beating valve leaflet, reduce the movement amplitude of the valve leaflet, and cooperate with the clamping assembly 13 to clamp and fix the valve leaflet.

The support 152 can be made of a resilient and/or flexible material to accommodate the anatomy of the leaflet and the amplitude of movement of the leaflet and avoid damaging the leaflet. The elastic material is preferably a shape memory material. The support 152 may be made of a metal material, a polymer material, or a metal-polymer composite material. Preferably, the support 152 is a mesh balloon woven from a plurality of wires, such as nitinol wires.

The support arm chamber 1205 of the pipe body 12 communicates with the exhaust joint 11120, the rotation shaft 1111 is provided with a support arm passage 1111e (see fig. 22) communicating with the support arm chamber 1205 in the axial direction H, and after the support arm 151 passes through the seal 1113 and the support arm passage 1111e, the seal 1113 blocks the communication of the support arm passage 1111e with the support arm chamber 1205 so as to exhaust the gas in the support arm chamber 1205 through the exhaust joint 11120.

Referring to fig. 6 and 12, the detection assembly 16 is used to detect whether the leaflet is clamped between the distal collet 132 and the proximal collet 133. Probe assembly 16 includes a probe 161, probe 161 movably mounted in tube 12, and a distal end of probe 161 extending from proximal collet 133 into distal collet 132 when distal collet 132 is closed with proximal collet 133. The lumen of the tube 12 includes a probe lumen 1206, i.e., the tube 12 is provided with a probe lumen 1206 along an axial direction, the probe lumen 1206 extends through the proximal and distal walls of the tube 12, and the probe 161 is movably mounted in the probe lumen 1206. In the illustrated example, the probe assembly 16 includes two probes 161, a left probe 1611 and a right probe 1612, positioned side-by-side. The axial length of the probe 161 is greater than the axial length of the tube 12. The distal collet 132 is also provided with two probe receiving cavities 1323 opposite the two probe cavities 1206, respectively, for receiving the distal ends of the probes 161. Because the distal wall of the tube 12 acts as the proximal collet 133, when the proximal collet 133 and the distal collet 132 are closed, the distal end of the probe 161 extends from the probe chamber 1206 and is received in the probe receiving chamber 1323, i.e., the distal end of the probe 161 extends from the proximal collet into the distal collet 132.

When the proximal collet 133 and the distal collet 132 are closed, if the leaflet is clamped between the proximal collet 133 and the distal collet 132 and the leaflet edge contacts the clamping pushrod 131, the distal end of the probe 161 is blocked by the leaflet from advancing distally after passing out of the proximal collet 133, indicating that the leaflet clamping effect is good and puncturing can be performed. In addition, when the distal end of the probe 161 is blocked by the leaflet from entering the probe receiving cavity 1323, it also indicates that the position between the leaflet edge and the suture 141 is relatively fixed, improving the therapeutic effect of the implantation of the suture 141. Therefore, the clamping effect of the valve leaflet can be effectively detected by the probe 161 with a mechanical structure, and the structure is simple and the operation is convenient.

The probe chamber 1206 of the tube body 12 communicates with the exhaust joint 11120, the rotation shaft 1111 is provided with a probe passage 1111f (see fig. 22) communicating with the probe chamber 1206 in the axial direction H, and after the probe 161 passes through the seal 1113 and the probe passage 1111f, the seal 1113 blocks the communication of the probe passage 1111f with the probe chamber 1206 so as to exhaust the gas in the probe chamber 1206 through the exhaust joint.

The number of plunger chambers 120, traction chamber 1201, puncture chamber 1204, and probe chamber 1206 is set corresponding to the number of traction wires 1221, puncture needles 171, probes 161, and clamp plungers 131. In other embodiments, the number of pull wires 1221, piercing needles 171, probes 161, and clamping pushers 131 may be a single.

Referring to fig. 5 and 15-19, the rotation mechanism 111 of the handle assembly 11 further includes a rotary link 1114. The rotary link 1114 is provided with a rotary shaft chamber 1114a in the axial direction. The rotating member 1112 includes a rotating member 1112a and a first connecting tube 1112b protruding from a proximal end of the rotating member 1112a, wherein the first connecting tube 1112b has a first inner cavity 1112H along an axial direction H, the rotating member 1112a has a second inner cavity 1112k along the axial direction H, and the first inner cavity 1112H communicates with the second inner cavity 1112k. The rotary shaft 1111 is inserted into the rotary shaft cavity 1114a and fixedly connected with the rotary connecting piece 1114, the rotary connecting piece 1114 is inserted into the first inner cavity 1112h and fixedly connected with the rotary piece 1112 in a sealing way, the tube body 12 is inserted into the second inner cavity 1112k and fixedly connected with the rotary piece 1112 in a sealing way, and a space exists between the proximal end wall of the tube body 12 and the distal end wall of the rotary connecting piece 1114.

It will be appreciated that the rotary shaft 1111 is coupled to the rotary member 1112 via the rotary connector 1114, and the seal 1113 may be disposed in the rotary shaft cavity 1114a of the rotary connector 1114 by extrusion. There is a spacing between the proximal wall of the tube 12 and the distal wall of the rotary link 1114 that prevents the proximal openings of the multiple lumens of the tube 12 from being blocked by the distal wall of the rotary link 1114 so that the exhaust fitting 11120 provided on the rotary link 1112 can communicate with the multiple lumens of the tube 12.

Specifically, the distal end wall of the rotary link 1114 is provided with a through-hole 1114e communicating with the rotary shaft chamber 1114a, the through-hole 1114e has a smaller diameter than the radial dimension of the rotary shaft chamber 1114a, the seal 1113 is accommodated in the rotary shaft chamber 1114a, and the rotary shaft 1111 presses the seal 1113 between the distal end wall of the rotary shaft 1111 and the distal end wall of the rotary link 1114. In this way, the seal 1113 may block the communication of the push rod channel 1111c of the rotary shaft 1111 with the push rod chamber 120 of the tube body 12, the communication of the puncture channel 1111d of the rotary shaft 1111 with the puncture chamber 1204 of the tube body 12, the communication of the support arm channel 1111e of the rotary shaft 1111 with the support arm chamber 1205 of the tube body 12, and the communication of the probe channel 1111f of the rotary shaft 1111 with the probe chamber 1206 of the tube body 12 after the push rod 131, the support arm 151, the probe 161, and the puncture needle 171 are gripped through the through holes thereof. The clamping pushrod 131, the supporting arm 151, the probe 161, and the puncture needle 171 are tightly attached to the through hole of the sealing member 1113, so as to achieve a sealing effect and to block communication between each passage of the rotating shaft 1111 and each lumen corresponding to the tube body 12.

In other examples, the seal 1113 may be directly glued to the distal end wall of the rotary connector 1114 to seal the through-hole 1114e, or be sealingly connected to the inner surface of the first cylinder 1112b of the rotary connector 1112 by gluing, or be directly glued to the distal end wall of the rotary shaft 1111, so long as the seal 1113 is ensured to block communication between the respective channels of the rotary shaft 1111 and the respective lumens of the tube 12, while not affecting communication between the exhaust fitting 11120 and the multiple lumens of the tube 12. The exhaust fitting 11120 may be disposed on the first connection tube 1112b of the rotary member 1112, and communicate with the first lumen 1112h, communicating with the plurality of lumens of the body 12 through the first lumen 1112 h.

Referring to fig. 20 to 22, the limiting strips 1111a are disposed on both sides of the rotary shaft 1111 along the axial direction H, and the rotary shaft cavity 1114a of the rotary connector 1114 is concavely provided with a limiting slot 1114b. When the rotary shaft 1111 is inserted into the rotary shaft cavity 1114a of the rotary connector 1114, the limit clamping strip 1111a is clamped and fixed with the limit clamping groove 1114b. In this way, a fixed connection of the rotary shaft 1111 to the rotary connector 1114 is achieved. The rotating shaft 1111 is provided with a plurality of channels 1111b corresponding to the tube body 12, such as a puncture channel 1111d, a support arm channel 1111e and a probe channel 1111f, the rotating shaft 1111 is provided with a push rod channel 1111c and a moving groove 1111g along the axial direction H, the push rod channel 1111c is used for matching with the clamping operation mechanism 134, the moving groove 1111g is used for matching with the detection operation mechanism 160 and the support operation mechanism 153, wherein the push rod channel 1111c and the moving groove 1111g are respectively located at two sides of the limit clamping strip 1111a, the moving groove 1111g is communicated with the plurality of channels 1111b, i.e. the moving groove 1111g is communicated with the puncture channel 1111d, the support arm channel 1111e and the probe channel 1111 f.

Referring to fig. 5, the rotary connecting member 1114 is provided with an annular flange 1112m along the circumferential direction of the outer wall thereof, the rotary connecting member 1114 is sleeved with a sealing ring 1112g, the proximal end of the first connecting tube 1112b is provided with an annular step along the circumferential direction of the first inner cavity 1112h, and the rotary connecting member 1114 is inserted into the first inner cavity 1112h to fix the first connecting tube 1112b and the rotary connecting member 1114 in a clamping manner and press the sealing ring 1112g between the annular step and the annular flange 1112 m. In this way, a sealed and fixed connection of the rotary connection 1114 to the rotary part 1112 is achieved.

Specifically, one of the first inner cavity 1112h and the rotary connecting piece 1114 is provided with a limiting block, the other is provided with a limiting groove, and the first connecting tube 1112b and the rotary connecting piece 1114 are clamped and fixed through the matching of the limiting block and the limiting groove. In the example of fig. 18 and 19, the rotary connector 1114 is provided with a stopper 1114d, and the first inner cavity of the first connecting tube 1112b is provided with a stopper groove (not shown).

Referring to fig. 5, 23 and 24, the rotation mechanism 111 further includes a spindle 1110. The shaft 1110 has a lumen 1110a formed therein, and the proximal end of the tube 12 is received within the shaft 1110 and sealingly secured thereto. The spindle 1110 is provided with an annular groove along the circumference of the outer wall thereof, the annular groove accommodates a sealing ring 1112g, the spindle 1110 is clamped and fixed in the second inner cavity 1112k, and the sealing ring 1112g is pressed between the spindle 1110 and the rotating body 1112 a. In this way, a sealed and fixed connection of the tube body 12 to the rotary member 1112 is achieved.

Specifically, the proximal end of the main body 1211 of the tube 12 is accommodated in the through cavity 1110a and is adhered and fixed, and there is no gap between the two, so that the proximal end of the main body 1211 of the tube 12 can be substantially flush with the proximal end of the spindle 1110, so as to facilitate threading and clamping the push rod 131, the support arm 151, the probe 161, the puncture needle 171, and the like. One of the second inner cavity 1112k and the spindle 1110 is provided with a bump 1112e, the other is provided with a fixing groove 1110e, and the spindle 1110 and the rotating body 1112a are clamped and fixed with the fixing groove 1110e through the cooperation of the bump 1112 e. In the example of fig. 19 and 24, the second lumen 1112k is provided with a bump 1112e and the spindle 1110 is provided with a fixing groove 1110e.

Referring to fig. 23-25, the handle assembly 11 further includes an identification housing 112 and a bending mechanism 113. The turn-down mechanism 113 includes a turn-down valve axially movably mounted on the spindle 1110 and a turn-down knob 1132 threadably engaged with the turn-down valve. The wire hole 1214 at the proximal end of the pulling chamber 1201 is generally located at the junction of the body section 1211 and the distal end of the mandrel 1110. The spindle 1110 has a filament outlet 1110b along the axial direction H and a stopper 1110c with a notch on the outer side thereof. The proximal end of the traction wire 1221 extends out of the traction cavity 1201 and passes through the wire outlet hole 1214 and the notch of the wire outlet groove 1110b and the stop ring 1110c to be fixedly connected with the bending valve 1131. The proximal end of the bending valve 1131 is provided with a buckle 1131a with external threads, and a groove 1131b matched with a protrusion extending along the axial direction H on the mandrel 1110 is arranged in the buckle 1131a, so that the bending valve 1131 can be limited to rotate. Thus, turning the turn knob 1132 drives the turn valve 1131 to move axially along the mandrel 1110, thereby driving the pull wire 1221 to pull the adjustable bend segment 1212 to bend or return to a straight position. The distal end of bend valve 1131 is provided with a marker, the marker housing 112 is provided with an indication scale corresponding to the bending angle, and the bending angle of the adjustable bending section 1212 of the pipe body 12 can be determined by indicating the position of the marker by the marker housing 112.

Referring to fig. 19 and 23, the rotation mechanism 111 of the handle assembly 11 further includes a fixing member 1115, and the fixing member 1115 is sleeved on the spindle 1110 and is rotatably connected with the rotating body 1112 a. One of the holder 1115 and the rotary body 1112a is provided with a resilient member 1116, and the other is provided with a plurality of indexing portions 1112f which cooperate with the resilient member 1116. The resilient member 1116 moves between the plurality of indexing sections 1112f as the rotary member 1112 rotates relative to the stationary member 1115.

Specifically, the rotary body 1112a includes a second connection cylinder 1112d protruding from the distal end of the cylindrical body 1112 c. The fixing member 1115 is in a circular cylinder structure and is provided with a connecting hole 1115a, the second connecting cylinder 1112d of the rotating member 1112 is penetrated into the connecting hole 1115a of the fixing member 1115 to realize rotary connection, and then is sleeved on the mandrel 1110 to enable the protruding block 1112e on the second connecting cylinder 1112d to be matched with the fixing groove 1110e on the mandrel 1110 to be connected and fixed, so that when the rotating member 1112 rotates, the mandrel 1110 is driven to rotate, and the tube 12 is driven to rotate. The fixing member 1115 is provided with an adjusting hole 1115b, an elastic element 1116 such as a plunger elastic screw is disposed in the hole, a plurality of equally spaced indexing portions 1112f such as indexing grooves are disposed on the columnar body of the rotating member 1112, when the rotating member 1112 rotates relative to the fixing member 1115, the elastic element 1116 is sequentially clamped into the indexing grooves, and an operator can determine the number of times the elastic element 1116 is clamped into the indexing grooves according to sound or feel, so as to determine the rotation angle of the rotating member 1112.

Referring to fig. 15 and 26, the rotation mechanism 111 further includes a connection member 1117, the connection member 1117 is provided with a rotation shaft clamping groove 1117a and a puncture handle groove 1117b which are communicated with each other in the axial direction H, the proximal end of the rotation shaft 1111 is inserted into the rotation shaft clamping groove 1117a to be clamped and fixed, and the puncture handle 172 is axially moved and accommodated in the puncture handle groove 1117 b. Specifically, a rotation shaft locking groove 1117a is provided in the distal end of the connection member 1117, and the proximal end of the rotation shaft 1111 is fixedly connected to the rotation shaft locking groove 1117 a. A piercing handle slot 1117b is provided in the proximal end of the connecting member 1117, wherein the radial dimension of the rotating shaft slot 1117a is greater than the radial dimension of the piercing handle 172 slot, and the piercing handle slot 1117b allows the piercing handle 172 to be positioned.

Referring to fig. 16 and 27, the handle assembly 11 further includes a housing 110 rotatably coupled to the rotation mechanism 111, and the housing 110 includes an upper housing 1101 and a lower housing 1102 which are detachably closed, and the upper housing 1101 and the lower housing 1102 form an inner cavity for accommodating the rotation shaft 1111, the rotation link 1114, the connection member 1117, and the like. The rotary connector 1114 is provided with a housing groove, and the first connecting tube 1112b of the rotary connector 1112 is also provided with a housing groove. The inner sides of the distal ends of the upper housing 1101 and the lower housing 1102 are respectively provided with two clamping blocks which are respectively clamped with the housing clamping grooves of the rotating member 1112 and the housing clamping grooves of the rotating connecting member 1114, but the rotating member 1112 and the rotating connecting member 1114 are not limited to rotate relative to the housing 110. The connecting member 1117 is provided with a connecting slot 1117c, and the distal end of the housing 110 is provided with a connecting buckle, and the connecting member 1117 is connected with the housing 110 through the connecting slot 1117c and the connecting buckle, so that the axial movement of the connecting member 1117 can be limited, but the connecting member 1117 is not limited to rotate together with the rotating shaft 1111 relative to the housing 110.

Referring to fig. 11, the clamping assembly 13 further includes a clamping operation mechanism 134 fixedly connected to the proximal end of the clamping pushrod 131. Referring to fig. 14, the support assembly 15 further includes a support operating mechanism 153 fixedly coupled to the proximal end of the support arm 151. Referring to fig. 16, the probe assembly 16 is further fixedly coupled to a probe actuator 160 at the proximal end of a probe 161. Referring to fig. 21 and 22, the rotary shaft 1111 is provided with a push rod passage 1111c along the axial direction H for engaging the clamping operation mechanism 134, and a moving groove 1111g for engaging the detection operation mechanism 160 and the support operation mechanism 153. Wherein, the push rod channel 1111c and the moving groove 1111g are respectively located at two sides of the limit clip strip 1111a, and the moving groove 1111g is communicated with the puncture channel 1111d, the support arm channel 1111e and the probe channel 1111 f.

Referring to fig. 11 and 28, the clamping operation mechanism 134 includes a first moving member 1341 and a first transmission member 1342 that are rotatably coupled. The first moving member 1341 is fixedly connected to the proximal end of the clamping pushrod 131, the first moving member 1341 is axially movably sleeved on the rotating shaft 1111, and the rotating member 1112 rotates to drive the first moving member 1341 to rotate relative to the first driving member 1342. It is understood that the rotating socket in the present application refers to that the first transmission member 1342 is sleeved on the outer periphery of the first moving member 1341, and the first transmission member 1342 and the first moving member 1341 can rotate relatively to each other, for example, when the first transmission member 1342 is kept stationary, the first moving member 1341 can rotate relatively to the first transmission member 1342. And because the first moving member 1341 and the first transmission member 1342 are sleeved with each other, they can only rotate relatively but cannot move relatively. For example, the first moving member 1341 is provided with a rotation groove 1341c on the circumferential side, and the first transmission member 1342 is provided with a limit protrusion 1342a protruding therefrom, and the limit protrusion 1342a is located in the rotation groove 1341c, such that the first moving member 1341 can rotate relative to the first transmission member 1342 but cannot move relative thereto. In addition, in this application, the axial movement sleeve joint means that the first moving member 1341 is sleeved outside the rotating shaft 1111, and the first moving member 1341 is provided with a first boss 1341a matched with a push rod channel 1111c of the rotating shaft 1111 and a first clamping groove 1341b matched and connected with a limit clamping strip 1111a of the rotating shaft 1111, so as to ensure that the first moving member 1341 can only move axially on the rotating shaft 1111, but cannot rotate relatively. In summary, the first moving member 1341 drives the first transmission member 1342 to move axially on the rotating shaft 1111, and when the rotating shaft 1111 rotates, the first moving member 1341 is driven to rotate relative to the first transmission member 1342.

The clamp operating mechanism 134 also includes an operating knob 1343. The proximal end of the housing 110 is provided with first limiting grooves 1103 along two radial sides. Two sides, namely two side portions 1342b, of the first transmission member 1342 extend from the first limiting through groove 1103, and an operation knob 1343 is sleeved on the casing 110 and is in threaded connection with the two side portions 1342b of the first transmission member 1342. Thus, by rotating the operation knob 1343 to axially move the first transmission member 1342, the first transmission member 1342 drives the first moving member 1341 to axially move, thereby driving the clamping pushrod 131 to axially move, so that the distal collet 132 and the proximal collet 133 are opened or closed. The first limiting groove 1103 has an axial length and can limit the moving distance of the first driving member 1342, so as to ensure the opening range of the distal chuck 132 and the proximal chuck 133.

Referring to fig. 14, the supporting operation mechanism 153 includes a second moving member 1531, a second transmission member 1532, and an operation button 1538. The second moving member 1531 is fixedly connected to the proximal end of the support arm 151, and the second transmission member 1532 is rotatably sleeved on the second moving member 1531, so that the two members can rotate relatively but cannot move relatively. The second moving member 1531 is provided with a second boss 1533 matching with the moving groove 1111g of the rotating shaft 1111 and a second clamping groove 1534 matching and connected with the limiting clamping strip 1111a of the rotating shaft 1111, so as to form a moving socket, so that the second moving member 1531 can only move along the axial direction H on the rotating shaft 1111. The second moving member 1531 is provided with a puncture hole 1535 and a probe hole 1536 on the second boss 1533 for the puncture needle 171 and the probe 161 to pass through, respectively.

The second transmission member 1532 is provided with a sliding slot 1537, the upper housing 1101 is provided with a corresponding second limiting slot 1104, the operation button 1538 is movable in the sliding slot 1537, and the operation button 1538 is exposed from the second limiting slot 1104 and is clamped on the outer surface of the upper housing 1101. The axial slot of the second limiting slot 1104 can enable the operating button 1538 to operate the second transmission member 1532 to move in the axial direction H, and the radial slot can limit the axial movement of the operating button 1538.

Referring to fig. 16 and 29 to 32, the detection operating mechanism 160 includes a left detection operating member 1621 and a right detection operating member 1622, the left detection operating member 1621 and the right detection operating member 1622 being arranged in parallel along the axial direction H. The left detection operation part 1621 includes a third moving part 1621a and a third transmission part 1621b. The third moving member 1621a is fixedly coupled to the proximal end of the left probe 1611, and the third driving member 1621b is rotatably coupled to the third moving member 1621a such that the two members are rotatable relative to each other but are not axially movable relative to each other. The third moving part 1621a is provided with a third boss 1621c matched with the moving groove 1111g and a third clamping groove 1621d matched and connected with the limit clamping strip 1111a of the rotating shaft 1111 to form a moving sleeve, so that the third moving part 1621a can only move axially on the rotating shaft 1111. The right detection operation member 1622 includes a fourth moving member 1622a, a fourth transmission member 1622b. The fourth moving member 1622a is fixedly connected to the proximal end of the right probe 1612, the fourth driving member 1622b is rotatably coupled to the fourth moving member 1622a such that the fourth moving member 1622a is rotatable but axially immovable, and the fourth moving member 1622a is provided with a fourth boss 1622c engaged with the moving groove 1111g and a fourth slot 1622d engaged with the retaining strip 1111a of the rotating shaft 1111 to form a moving coupling such that the fourth moving member 1622a can only axially move on the rotating shaft 1111. The third moving member 1621a is provided with

penetration holes

1621e and 1622e on the third boss 1621c and the fourth moving member 1622a is provided on the fourth boss 1622c, respectively, for the penetration of the penetration needle 171.

The detection operating mechanism 160 further includes a fixing frame 163, a slide plate 164, a detection button 165, and a guide post 166. Guide holes are formed in two sides of the fixing frame 163 and are matched with the two guide posts 166 respectively, and a sliding groove 1631 is formed above the fixing frame to facilitate the sliding plate 164 to move back and forth. After the guide post 166 is mounted on the fixing frame 163, a third transmission member 1621b and a fourth transmission member 1622b which can move axially are respectively mounted, and springs are respectively mounted on both sides of the guide post 166. The sliding plate 164 is slidably disposed in the sliding groove 1631, the sliding plate 164 is provided with two driving grooves 1641 and a positioning table 1642, and the positioning table 1642 is provided with a positioning groove 1643. The third transmission part 1621b and the fourth transmission part 1622b are respectively provided with a stop platform 1621f and a stop platform 1622f, the sliding groove 1631 is provided with a through hole 1644, and the

stop platforms

1621f and 1622f of the third transmission part 1621b and the fourth transmission part 1622b pass through the through hole 1644 and are positioned in the driving groove 1641. The probe button 165 is provided with a mounting hole 1652, a positioning hole 1653, and a locking plate 1651. The upper housing 1101 is provided with a third limiting slot 1105, a positioning table 1642 is exposed from the third limiting slot 1105, the detection button 165 is sleeved on the positioning table 1642 through a mounting hole 1652, and the detection button 165 can move up and down on the positioning table 1642 and is fixed by mounting pins in the positioning hole 1653 and the positioning slot 1643. When the locking table 1651 of the detection button 165 is locked with the third limiting slot 1105, the sliding plate 164 is in a locked state, the springs are compressed, the stopping tables 1621f and 1622f of the third transmission member 1621b and the fourth transmission member 1622b are abutted with the driving slot 1641, the third transmission member 1621b and the fourth transmission member 1622b cannot move, the probe 161 is guaranteed to be in a contracted state, when the detection button 165 is lifted upwards, the sliding plate 164 is in an unlocked state, the elastic force of the springs releases the third transmission member 1621b and the fourth transmission member 1622b, so that the left and right probes 1612 move distally, and at this time, the sliding plate 164 also moves distally due to the movement of the third transmission member 1621b and the fourth transmission member 1622b, that is, the detection button 165 moves distally.

In this application, since the first moving member 1341 is rotatably connected to the first transmission member 1342 and axially movably connected to the rotation shaft 1111, the second moving member 1531 is rotatably connected to the second transmission member 1532 and axially movably connected to the rotation shaft 1111, the third moving member 1621a is rotatably connected to the third transmission member 1621b and axially movably connected to the rotation shaft 1111, the fourth moving member 1622a is rotatably connected to the fourth transmission member 1622b and axially movably connected to the rotation shaft 1111, and the rotation member 1112, the rotation connection member 1114, the rotation shaft 1111 and the connection member 1117 are rotatable with respect to the housing 110; when the rotary member 1112 rotates to drive the rotary shaft 1111 to rotate, the first moving member 1341 rotates relative to the first transmission member 1342, the second moving member 1531 rotates relative to the second transmission member 1532, the third moving member 1621a rotates relative to the third transmission member 1621b, the fourth moving member 1622a rotates relative to the fourth transmission member 1622b, the housing 110, the first transmission member 1342, the operation knob 1343, the second transmission member 1532, the operation button 1538, the third transmission member 1621b, the fourth transmission member 1622b, and the detection button 165 do not rotate together, and can always face the operator, so that the operator can conveniently and rapidly operate the operation knob 1343, the operation button 1538, and the detection button 165. When the tube 12 and the clamping assembly 13 are required to be rotated to change the opening orientations of the distal clamp 132 and the proximal clamp 133 to clamp different valve leaflets, only the rotating member 1112 is required to be rotated, and the whole heart valve suture device 1 is not required to be rotated, so that the operation is more convenient.

The procedure of implanting the suture 141 into the leaflet of the heart valve suture device 1 provided in the present application will be described below by taking the transapical intervention of the mitral valve as an example.

First, referring to fig. 33, a guide wire is introduced into the left ventricle LV along the apex puncture, the heart valve suture device 1 is passed across the valve leaflet along the guide wire to the left atrium LA, the support 152 is opened, the guide wire is retracted, and the device 1 is entirely retracted until the support 152 is under the valve leaflet for support;

then, referring to fig. 34, the distal collet 132 and the proximal collet 133 of the heart valve suture device 1 are opened, the suture 141 is implanted by turning the tube 12 to move the distal collet 132 until the distal collet 132 and the proximal collet 133 grip the leaflet between the distal collet 132 and the proximal collet 133 of the valve She Jinru;

finally, referring to fig. 35-36, after implantation of the suture 141 is completed, the distal collet 132 and the proximal collet 133 of the heart valve suture device 1 are opened to release the leaflets 2, the heart valve suture device 1 is retracted, and then the left ventricle LV is entirely withdrawn outside the body.

It should be noted that in this document, relational terms such as "first" and "second" and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

In the description of the present specification, a description referring to the terms "one embodiment," "certain embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present application. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

The foregoing is merely a specific embodiment of the application to enable one skilled in the art to understand or practice the application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the application. Thus, the present application is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A heart valve suture device, which is characterized by comprising a handle component, a tube body and a clamping component;

the handle assembly comprises a rotating mechanism, the rotating mechanism comprises a rotating shaft, a rotating piece and a sealing piece, the distal end of the rotating piece is fixedly connected with the proximal end of the tube body in a sealing way, the proximal end of the rotating piece is fixedly connected with the distal end of the rotating shaft in a sealing way, a push rod channel is axially arranged on the rotating shaft, a push rod cavity is axially arranged on the tube body, the push rod channel is communicated with the push rod cavity, the clamping assembly comprises a clamping push rod and a distal chuck arranged at the distal end of the clamping push rod, and the clamping push rod is movably arranged in the push rod cavity and the push rod channel in a penetrating way;

after the clamping push rod passes through the sealing piece and the push rod channel, the sealing piece blocks the communication between the push rod channel and the push rod cavity, the rotating piece is provided with an exhaust connector communicated with the push rod cavity, and the exhaust connector is used for communicating an exhaust pipe.

2. The heart valve suture device of claim 1, wherein the seal is located proximal to where the exhaust fitting communicates with the pushrod lumen.

3. The heart valve suture device of claim 1, wherein the seal is a flexible sealing gasket made of one of silicone, rubber, and graphite.

4. The heart valve suture device of claim 1, wherein the seal is provided with a through hole that is substantially closed in a natural state.

5. The heart valve suture device of claim 1, further comprising a puncture assembly and a suture assembly, the puncture assembly comprising a puncture needle, the suture assembly comprising a suture and a sleeve coupled to the suture, the sleeve being received in the distal collet, the puncture needle movably mounted in the tube, the puncture needle for puncturing the leaflet for connection with the sleeve.

6. The heart valve suture device of claim 5, wherein the tube is axially provided with a puncture lumen in communication with the exhaust fitting, the rotating shaft is axially provided with a puncture channel in communication with the puncture lumen, and the seal blocks communication of the puncture channel with the puncture lumen after the puncture needle passes through the seal and the puncture channel.

7. The heart valve suture device of claim 5, wherein the puncture assembly further comprises a puncture handle fixedly connected to the proximal end of the puncture needle, the rotation mechanism further comprises a connecting member, the connecting member is provided with a rotation shaft clamping groove and a puncture handle groove which are axially communicated, the proximal end of the rotation shaft is inserted into the rotation shaft clamping groove to be clamped and fixed, and the puncture handle is axially movably accommodated in the puncture handle groove.

8. The heart valve suture device of claim 1, further comprising a support assembly comprising a support arm movably mounted in the tube and a support member disposed at a distal end of the support arm for pushing the support member out of the tube distal end, the support member for supporting the leaflet.

9. The heart valve suture device of claim 8, wherein the tube is provided with a support arm lumen in communication with the exhaust fitting, the rotating shaft is axially provided with a support arm channel in communication with the support arm lumen, and the seal blocks communication of the support arm channel with the support arm lumen after the support arm passes through the seal and the support arm channel.

10. The heart valve suture device of claim 1, wherein the clamping assembly further comprises a proximal clamp that cooperates with the distal clamp to clamp the leaflet, the heart valve suture device further comprising a probe assembly comprising a probe movably mounted in the tube, a distal end of the probe extending from the proximal clamp into the distal clamp when the distal clamp is closed with the proximal clamp.

11. The heart valve suture device of claim 10, wherein the tube is axially provided with a probe lumen in communication with the exhaust fitting, the rotating shaft is axially provided with a probe channel in communication with the probe lumen, and the seal blocks communication of the probe channel with the probe lumen after the probe passes through the seal and the probe channel.

12. The heart valve suture device of claim 1, wherein the heart valve suture device is provided with a guidewire channel axially therethrough the tube and the distal clip, the guidewire channel for threading a guidewire.

13. The heart valve suture device of claim 1, wherein the tube comprises a main body section and an adjustable bend section disposed at a distal end of the main body section, the heart valve suture device further comprising a traction member coupled to the adjustable bend section for controlling the adjustable bend section to bend or return to a straight, the distal portion of the clamping pushrod having flexibility.

14. The heart valve suture device of any one of claims 1-13, wherein the rotation mechanism further comprises a rotation connector comprising a rotation body and a first connecting cylinder protruding from a proximal end of the rotation body, the rotation connector being provided with a rotation shaft cavity along an axial direction, the first connecting cylinder having a first inner cavity along an axial direction, the rotation body having a second inner cavity along an axial direction, the first inner cavity being in communication with the second inner cavity;

the rotary shaft is arranged in the rotary shaft cavity in a penetrating manner and is fixedly connected with the rotary connecting piece, the rotary connecting piece is arranged in the first inner cavity in a penetrating manner and is fixedly connected with the rotary piece in a sealing manner, the pipe body is arranged in the second inner cavity in a penetrating manner and is fixedly connected with the rotary piece in a sealing manner, and a space exists between the proximal end wall of the pipe body and the distal end wall of the rotary connecting piece.

15. The heart valve suture device of claim 14, wherein the distal wall of the rotational connector is provided with a through-hole communicating with the rotational shaft lumen, the through-hole having a smaller bore diameter than a radial dimension of the rotational shaft lumen, the seal being received in the rotational shaft lumen, the rotational shaft pressing the seal between the distal wall of the rotational shaft and the distal wall of the rotational connector.

16. The heart valve suture device of claim 14, wherein the rotary connector is provided with an annular flange along the circumference of the outer wall thereof, a sealing ring is sleeved on the rotary connector, the proximal end of the first connector barrel is provided with an annular step along the circumference of the first inner cavity, and the rotary connector is arranged in the first inner cavity in a penetrating manner so that the first connector barrel is clamped and fixed with the rotary connector and the sealing ring is pressed between the annular step and the annular flange.

17. The heart valve suture device of claim 14, wherein the rotation mechanism further comprises a mandrel, the proximal end of the tube is received in the mandrel and sealingly secured, the mandrel is circumferentially provided with an annular groove along its outer wall, the annular groove receives a sealing ring, and the mandrel is snap-secured in the second lumen and urges the sealing ring between the mandrel and the rotator.

18. The heart valve suture device of claim 17, wherein the rotation mechanism further comprises a fixture that is sleeved on the mandrel and rotatably coupled to the rotator, one of the fixture and the rotator being provided with a resilient element, the other being provided with a plurality of indexing portions that cooperate with the resilient element, the resilient element moving between the plurality of indexing portions as the rotator rotates relative to the fixture.

19. The heart valve suture device of claim 1, wherein the clamping assembly further comprises a clamping operating mechanism comprising a first moving member and a first transmission member rotatably coupled, the first moving member being fixedly coupled to the proximal end of the clamping pushrod, the first moving member being axially movably coupled to the rotating shaft, rotation of the rotating member rotating the first moving member relative to the first transmission member.

20. The heart valve suture device of claim 19, wherein the clamping operation mechanism further comprises an operation knob, the handle assembly further comprises a housing rotatably connected with the rotation mechanism, first limit through grooves are formed in two radial sides of a proximal end of the housing, two sides of the first transmission piece extend out of the first limit through grooves, and the operation knob is sleeved on the housing and is in threaded connection with two sides of the first transmission piece.