CN114681131A

CN114681131A - Valve stitching instrument

Info

Publication number: CN114681131A
Application number: CN202011602988.0A
Authority: CN
Inventors: 张庭超; 张伟伟
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-12-29
Filing date: 2020-12-29
Publication date: 2022-07-01

Abstract

The application provides a valve stitching instrument, which comprises a pushing device and a clamping device. The pushing device comprises a pushing catheter. The clamping device comprises a clamping push rod, a near-end chuck, a far-end chuck, a clamping operation mechanism and an elastic mechanism. The clamping push rod is movably arranged in the push catheter in a penetrating mode, the near-end chuck is arranged at the far end of the push catheter, the far-end chuck is arranged at the far end of the clamping push rod, the elastic mechanism is fixedly connected with the near end of the clamping push rod, and the clamping operation mechanism is movably connected with the near end of the clamping push rod and the elastic mechanism. After the clamping operating mechanism drives the clamping push rod to move from the far end to the near end to close the far end chuck and the near end chuck, the clamping operating mechanism compresses the elastic mechanism to enable the clamping operating mechanism to move towards the near end relative to the clamping push rod to generate sound feedback, and therefore the situation that an operator forcibly moves the clamping operating mechanism towards the near end to obtain the sound feedback and the valve leaflets are clamped and damaged by the far end chuck and the near end chuck in an excessive clamping mode is avoided.

Description

Valve stitching instrument

Technical Field

The application relates to the technical field of medical equipment, in particular to a valve stitching instrument.

Background

The mitral valve is a one-way "valve" between the Left Atrium (LA) and the Left Ventricle (LV), which ensures blood flow from the left atrium to the left ventricle. Referring to fig. 1, a normal, healthy mitral valve has a plurality of chordae tendineae. The valve leaves of the mitral valve are divided into an anterior leaf and a posterior leaf, when the left ventricle is in a diastole state, the two are in an opening state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contraction state, the chordae tendineae are stretched to ensure that the valve leaflets are not flushed to the atrium side by blood flow, and the anterior and posterior leaflets are closed well, thereby ensuring that blood flows from the left ventricle to the aorta through the aortic valve (AV for short). If the chordae tendineae or papillary muscles are diseased, such as the chordae tendineae of the posterior leaflet shown in fig. 2, and the mitral valve fails to return to the closed state as it would if it were in the normal state when the left ventricle were in the contracted state, the momentum of the blood flow may further cause the leaflets to fall into the left atrium, causing blood backflow.

Currently, surgical implantation of sutures is usually used to treat chordal tendineae, requiring invasive chest-opening techniques with general anesthesia and moderate-low temperature extracorporeal circulation as an auxiliary support. The surgical operation has the defects of complex operation process, high operation cost, high wound degree of patients, high complication risk, long hospitalization time, pain in the recovery process of the patients and the like.

There is an apparatus for implanting a suture by a minimally invasive method, which implants the suture by clamping a leaflet with a clamping device. The clamping device comprises a clamping push rod, a far-end chuck and a near-end chuck which are used for matching with and clamping valve leaflets, and a clamping operation mechanism connected to the near end of the clamping push rod. The clamping operating mechanism moves from the far end to the near end to close the far end chuck and the near end chuck, and when the clamping operating mechanism moves from the far end to the near end to a preset position, closing sound feedback is sent out. The operator can confirm whether the distal collet and the proximal collet are closed or not according to the sound feedback. However, due to the inevitable tolerance problem of the manufacturing process, the situation that the length of the clamping push rod is insufficient may occur, so that when the distal collet and the proximal collet clamp the valve leaflets to close, the clamping operation mechanism cannot move to the predetermined position to generate the sound feedback. Forcing the grasping mechanism proximally to confirm that the distal and proximal jaws are closed causes the distal and proximal jaws to over-grip the leaflets and thereby pinch the leaflets.

Disclosure of Invention

In order to avoid the problem that the valve blades are excessively clamped by the far-end clamping head and the near-end clamping head to clamp the valve blades, the application provides a valve stitching device.

In order to achieve the above purpose, the embodiment of the present application adopts the following technical solutions:

the application provides a valve stitching instrument, which comprises a pushing device and a clamping device. The pushing device comprises a pushing catheter; clamping device includes centre gripping push rod, near-end chuck, distal end chuck, centre gripping operating device and elastic mechanism, the dress is worn actively to the centre gripping push rod in the propelling movement pipe, the near-end chuck is located the distal end of propelling movement pipe, the distal end chuck is located the distal end of centre gripping push rod, elastic mechanism fixed connection the near-end of centre gripping push rod, centre gripping operating device swing joint the near-end of centre gripping push rod reaches elastic mechanism, centre gripping operating device drives the centre gripping push rod is made by distal end to near-end removal the distal end chuck with the near-end chuck is closed the back, centre gripping operating device compresses elastic mechanism makes centre gripping operating device for the centre gripping push rod takes place the displacement in order to send the sound feedback to the near-end.

The valve stitching instrument provided by the application is provided with the elastic mechanism, when the length of the clamping push rod is not long enough to enable the clamping operating mechanism to move from the far end to the near end to the preset position to send sound feedback, the elastic mechanism can be compressed to enable the clamping operating mechanism to move towards the near end relative to the clamping push rod and reach the preset position to send sound feedback, so that an operator is prevented from forcibly moving the clamping operating mechanism towards the near end to obtain the sound feedback, a valve leaf is clamped and damaged due to the fact that the far end chuck and the near end chuck excessively clamp the valve leaf, and safety and reliability of an operation are improved.

Drawings

FIG. 1 is a schematic diagram of a human heart under normal health conditions;

FIG. 2 is a schematic diagram of a human heart with broken chordae tendineae in the posterior leaflet;

FIG. 3 is a schematic perspective view of a valve stapler provided in accordance with an embodiment of the present application;

FIG. 4 is an exploded view of the valve stapler shown in FIG. 3;

FIG. 5 is a schematic perspective view of a suture provided in accordance with an embodiment of the present application;

FIG. 6a is a schematic perspective view of a probe portion of a valve stapler extending out of a pusher catheter according to an embodiment of the present application;

FIG. 6b is an enlarged schematic view of a partial region I of FIG. 6 a;

FIG. 7a is a schematic perspective view of a probe of a valve stapler fully disposed within a pusher catheter according to an embodiment of the present application;

FIG. 7b is an enlarged schematic view of a portion II of FIG. 7 a;

FIG. 8 is an exploded view of the valve stapler shown in FIG. 6 a;

FIG. 9 is an exploded view of the valve stapler shown in FIG. 7 a;

FIG. 10 is an exploded view of a push handle provided in accordance with an embodiment of the present application;

fig. 11 is a perspective view of a clamping operation mechanism of the clamping device according to an embodiment of the present application;

FIG. 12 is an exploded view of a clamping mechanism of a clamping device according to an embodiment of the present disclosure;

FIG. 13 is a schematic view of a piercing handle and safety provided in accordance with an embodiment of the present application in a locked state;

FIG. 14 is a schematic view of a piercing handle and safety provided in accordance with an embodiment of the present application in an unlocked state;

FIG. 15 is a perspective view of a puncturing device and a safety element according to an embodiment of the present disclosure;

FIG. 16 is another schematic view of a piercing handle and safety provided in accordance with an embodiment of the present application in an unlocked state;

FIG. 17 is a perspective view of a fuse provided in accordance with an embodiment of the present application;

FIG. 18 is a perspective view of a clamping assist device according to an embodiment of the present application;

FIG. 19 is a schematic perspective view of an auxiliary operating mechanism of a grip assistance apparatus according to an embodiment of the present application;

fig. 20 is a schematic view of a clamping aid in cooperation with a clamping device for clamping leaflets according to an embodiment of the present application;

FIG. 21 is a cross-sectional view of a pusher catheter provided in accordance with an embodiment of the present application;

fig. 22-33 are schematic views illustrating an implementation process of implanting sutures into leaflets of a valve suturing device provided in an embodiment of the present application.

Detailed Description

In order to make the objects, technical solutions and advantages of the present application more clear, the present application will be further described in detail with reference to the accompanying drawings.

It should be understood that expressions such as "include" and "may include" that may be used in the present application indicate the presence of the disclosed functions, operations or constituent elements, and do not limit one or more additional functions, operations and constituent elements. In the present disclosure, terms such as "including" and/or "having" may be interpreted as indicating specific characteristics, numbers, operations, constituent elements, components, or combinations thereof, but may not be interpreted as excluding the existence or addition possibility of one or more other characteristics, numbers, operations, constituent elements, components, or combinations thereof.

Further, in this application, the expression "and/or" includes any and all combinations of the associated listed words. For example, the expression "a and/or B" may include a, may include B, or may include both a and B.

In the present application, expressions including ordinal numbers such as "first" and "second" and the like may modify the respective elements. However, such elements are not limited by the above expression. For example, the above description does not limit the order and/or importance of the elements. The above expressions are only used to distinguish one element from another. A first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of the present disclosure.

When a component is referred to as being "connected" or "accessed" to other components, it should be understood that: not only may the component be directly connected or accessed to the other component, but there may also be another component between the component and the other component. On the other hand, when components are referred to as being "directly connected" or "directly accessing" other components, it is understood that no components exist therebetween.

In the field of interventional medical device technology, a position close to the operator is generally defined as proximal and a position far from the operator as distal. The direction of the central axis of an object such as a column or a pipe is defined as the axial direction. Radial refers to a direction through the central axis in a radial plane, e.g., a straight direction along a diameter or radius, or a straight direction perpendicular to the central axis.

Referring to fig. 3 and 4, one embodiment of the present application provides a valve stapler 100 for implanting a suture 60 (shown in fig. 5) into a patient to replace a diseased or broken chordae tendineae in the heart of the patient; or for implanting a plurality of sutures 60 into a patient and securing them to one another to effect edge-to-edge repair of a heart valve (e.g., mitral valve, tricuspid valve). The valve suturing device 100 comprises a clamping device 10, a puncturing device 20, a pushing device 30, a clamping auxiliary device 40 and a detecting device 50. The pusher device 30 is used to deliver the holding device 10 to a predetermined position near the valve. The holding device 10 is used to receive the suture 60 and hold the leaflets of the valve. The holding aid 40 is adapted to be supported on the lower surface of the leaflet and cooperate with the holding device 10 to hold the leaflet. The detection device 50 is used for detecting whether the clamping device 10 clamps the valve leaflets of the valve and the clamping effect on the valve leaflets. The puncture device 20 is used to puncture the valve after the valve is held by the holding device 10.

The repair of the valve chordae will be described in detail by way of example with the suture 60 being a prosthetic chordae. Referring to fig. 5, suture 60 includes a length of flexible suture body 62. The suture body 62 has opposing first and second ends. A fastener 64 is attached to the first end and/or the second end. The fastener 64 is adapted to be non-removably secured or removably secured to the puncturing device 20. The anchor 64 may be provided at both ends of the suture body 62, or may be provided only at one end of the suture body 62. In the present embodiment, the suture thread main body 62 is provided with the fixing pieces 64 at both ends. The number of the sewing thread 60 may be one, or two or more. The material of the suture main body 62 may be a polymer material compatible with a human body or a relatively soft metal material, and is preferably a polymer material such as polyethylene terephthalate (PET), expanded polytetrafluoroethylene (e-PTFE), and the like. In this embodiment, the suture body 62 is used to be implanted into the heart to replace a diseased chordae tendineae in the heart, that is, one end of the suture body 62 is fixed to the leaflet and the other end is fixed to the ventricular wall or a papillary muscle to replace the diseased chordae tendineae and maintain the tension between the leaflet and the ventricular wall.

Referring to fig. 6a to 10, the pushing device 30 includes a pushing catheter 32 and a pushing handle 34 connected to a proximal end of the pushing catheter 32. The push handle 34 is used to manipulate the entire valve stapler 100 to be pushed distally or retracted proximally. In this embodiment, the pushing handle 34 includes a first housing 342 and a second housing 344 detachably covering the first housing 342, and the pushing catheter 32 is a tubular body having a certain axial length or a rod-shaped body having an inner cavity.

Referring to fig. 6 a-7 b, a holding device 10 includes a holding pusher 12 containing a suture 60 and distal and

proximal jaws

14, 16 for cooperatively holding a leaflet. Distal collet 14 is disposed at the distal end of holding pusher rod 12 and proximal collet 16 is disposed at the distal end of pusher catheter 32. The holding push rod 12 is movably inserted into the inner cavity of the push handle 34 and the push conduit 32.

The holding push rod 12 is a tubular body or a hollow rod body with a certain axial length, the cross section is preferably oval or circular, and a suture passage 122 (shown in fig. 4) is axially arranged in the holding push rod 12. Two suture receiving cavities 142 (shown in fig. 7 b) are formed in the distal cartridge 14 and communicate with the suture passage 122, and the two suture receiving cavities 142 respectively penetrate the clamping surface of the distal cartridge 14. Suture body 62 of suture 60 is received in suture passage 122 and suture receiving cavity 142. The gripping surface of distal cartridge 14 is further formed with two fastening cavities 144 (shown in FIG. 7 b) for receiving two fasteners 64 of suture 60, respectively. Each of the fixation lumens 144 is in axial communication with a respective one of the suture receiving lumens 142.

Referring to fig. 4, 11 and 12, the clamping device 10 further includes a clamping mechanism 18 and a resilient mechanism 19 connected to the proximal end of the clamping rod 12. The gripping and operating mechanism 18 is provided on the push handle 34. A clamp actuator 18 is used to actuate distal jaw 14 to close or separate from proximal jaw 16. In this embodiment, proximal jaw 16 and distal jaw 14 are shaped to conform to the shape of pusher catheter 32, and distal jaw 14 and proximal jaw 16 form a smooth-surfaced unitary body when closed to facilitate pushing and reduce trauma to the patient's wound.

The proximal end of the holding push rod 12 extends from the proximal end of the pushing catheter 32, the elastic mechanism 19 is fixedly connected with the proximal end of the holding push rod 12, and the holding operation mechanism 18 is movably connected with the proximal end of the holding push rod 12 and the elastic mechanism 19. After the clamping actuator 18 drives the clamping rod 12 to move from the distal end to the proximal end to close the distal collet 14 and the proximal collet 16, the clamping actuator 18 compresses the elastic mechanism 19, so that the clamping actuator 18 moves proximally relative to the clamping rod 12 to generate an audible feedback.

Because the valve suturing device 100 is provided with the elastic mechanism 19, when the length of the clamping push rod 12 is not enough to enable the clamping operating mechanism 18 to move from the far end to the near end to the preset position to generate the sound feedback, the elastic mechanism 19 can be compressed to enable the clamping operating mechanism 18 to move towards the near end relative to the clamping push rod 12 to reach the preset position to generate the sound feedback, so that the situation that an operator forcibly moves the clamping operating mechanism 18 towards the near end to obtain the sound feedback to enable the far end clamping head 14 and the near end clamping head 16 to excessively clamp the valve leaflet to damage the valve leaflet is avoided, and therefore, the safety and the reliability of the operation are improved.

The inner surface of the second housing 344 of the pushing handle 34 is provided with a sliding groove 345 (as shown in fig. 9 and 10) along the axial direction, the clamping operation mechanism 18 comprises a connecting sliding member 182 and an operation component 184, and the sliding member 182 is slidably arranged in the sliding groove 345. The sliding groove 345 serves to guide and limit the movement of the sliding member 182. The elastic mechanism 19 is movably connected with the sliding piece 182, and the elastic mechanism 19 is fixedly connected with the near end of the clamping push rod 12. The proximal end of the holding pushrod 12 abuts the slide 182. The operating assembly 184 is used for driving the sliding member 182 to slide axially along the sliding groove 345. Specifically, the sliding member 182 defines a push rod mounting hole 1822, the proximal end of the clamping push rod 12 is received in the push rod mounting hole 1822 to abut against the sliding member 182, and the elastic mechanism 19 is partially received in the push rod mounting hole 1822 and is fixedly connected to the proximal end of the clamping push rod 12. Thus, the elastic mechanism 19 and the clamping plunger 12 are partially inserted into the plunger mounting hole 1822 of the sliding member 182 for connection, the proximal end of the clamping plunger 12 is held in the plunger mounting hole 1822 against the sliding member 182, and the sliding member 182 can compress the elastic mechanism 19 to cause the clamping operation mechanism 18 to move proximally relative to the clamping plunger 12 to reach a predetermined position for audible feedback.

Further, the operating member 184 is elastically connected to the sliding member 182, the inner surface of the pushing handle 34 is further provided with a guide groove 347, and the operating member 184 is slidably disposed in the guide groove 347 (as shown in fig. 10). The guide groove 347 includes a radial guide groove 3471 and an axial guide groove 3473 connected, and the axial guide groove 3473 is closer to the central axis of the push handle 34 than the radial guide groove 3471. The guide groove 347 is generally an L-shaped groove structure, and the radial guide groove 3471 communicates with the proximal end of the axial guide groove 3473. The operating member 184 is switchable between a natural state and a compressed state, and when the operating member 184 moves from the axial guide groove 3471 to the radial guide groove 3473, the operating member 184 is switched from the compressed state to the natural state to impact the push handle 34 to generate an audible feedback.

For convenient operation, the sliding member 182 is connected with operation components 184 on both sides. The push handle 34 is also provided with an operating channel 348 (shown in fig. 9 and 10) on the side. The operation member 184 includes a sliding plate 1841, an operation member 1843, and an elastic member 1845. The sliding plate 1841 is connected with an operating piece 1843, the sliding plate 1841 is arranged in the guide slot 347 in a sliding way, and the operating piece 1843 is clamped in the operating through slot 348 and is exposed out of the pushing handle 34. The operating through-slot 348 functions to limit the axial travel distance of the clamp operating mechanism 18. Movement of slide 182 is caused by operation of operating member 1843 in operating channel 348, thereby controlling the opening and closing of distal chuck 14 and proximal chuck 16. An elastic member 1845 is coupled between the sliding member 182 and the sliding plate 1841, and when the elastic member 1845 is transformed from a compressed state to a natural state, the operating member 1843 impacts the push handle 34 to generate an audible feedback, which facilitates the operator to confirm that the distal chuck 14 and the proximal chuck 16 are closed to hold the valve leaflets.

The clamp operating mechanism 18 further includes a mounting bar 186, the mounting bar 186 being coupled between the slide 182 and the operating member 1843. Specifically, the sliding member 182 is provided with mounting bars 186 at both sides in the radial direction, and the operation member 1841 is connected with the mounting bars 186. The elastic member 1845 is sleeved outside the mounting rod 186 and disposed between the sliding member 182 and the operating member 1843. In the illustrated example, the slide plate 1841 is integral with the operating member 1843, i.e., the mounting bar 186 is also coupled between the slide 182 and the slide plate 1841.

When slide plate 1843 is positioned in radial guide slot 3471, distal cartridge 14 is closed with proximal cartridge 16; when slide plate 1843 is positioned in axial guide slot 3473, distal cartridge 14 is separated from proximal cartridge 16. The operating member 184 is transformed between a natural state and a compressed state by the deformation of the elastic member 1845. The elastic member 1845 may be a spring. When the elastic member 1845 is transformed from the natural state to the compressed state, the sliding plate 1843 may move from the radial guide groove 3471 to the axial guide groove 3473; when resilient member 1845 is transitioned from the compressed state to the natural state, sliding plate 1843 is moved from axial guide slot 3471 to radial guide slot 3473, causing operating member 1841 to impact push handle 34 to generate an audible feedback indicating to the operator that distal cartridge 14 and proximal cartridge 16 have been closed.

The operation member 1843 includes an operation portion 1846, a connection portion 1847, and a feedback portion 1848 connected in this order. The connecting portion 1847 is inserted into the operating through groove 348, the operating portion 1843 is located outside the pushing handle 34, the feedback portion 1848 is accommodated in an inner cavity of the pushing handle 34, and when the elastic member 1845 is converted from a compressed state to a natural state, the feedback portion 1848 impacts an inner side surface of the pushing handle 34 to generate sound feedback. In this embodiment, the feedback portion 1848 extends in the axial direction, and the feedback portion 1848 can abut against the inner surface of the second housing 344 of the push handle 34, thereby enhancing the stability of the grip operation mechanism 18. The operation portion 1846, the connection portion 1847, and the feedback portion 1848 may be integrally molded or may be separately provided, and the configuration of the operation member 1843 is not limited in the present application.

It will be appreciated that slide plate 1841 is positioned in radial guide slot 3471 when distal cartridge 14 and proximal cartridge 16 are closed (as shown in fig. 22). When the operating portion 1846 is pressed by the operator, the operating member 1843 compresses the elastic member 1845, so that the sliding plate 1841 can move from the radial guide groove 3471 to the axial groove 3473, and the control operating member 1843 drives the sliding member 182 and the holding push rod 12 to move distally, so that the distal chuck 14 is away from the proximal chuck 16, and an expanded state is formed as shown in fig. 23, and a leaflet containing space is formed between the distal chuck 14 and the proximal chuck 16. After the fine valve stapler 100 has moved the valve leaflet into the leaflet receiving space (as shown in fig. 24), the control operation member 1843 moves proximally, the sliding plate 1841 can move from the axial guide groove 3473 to the radial guide groove 3471, and the sliding member 182 moves the clamping push rod 12 proximally, so that the distal clamping head 14 approaches the proximal clamping head 16, and the clamping state is shown in fig. 20 and 25. At this time, the leaflet is clamped and fixed by the clamping device 10. Since the sliding plate 181 is located in the axial guide groove 3473, the elastic member 1845 is compressed, and when the sliding plate 1841 moves from the axial guide groove 3473 to the radial guide groove 3471, the elastic member 1845 returns to the natural state to generate elastic force, so that the feedback portion 1848 impacts the inner side surface of the push handle 34 to generate "click" sound feedback. When the operator or user hears the "click" sound, it can be determined that the distal clip 14 and the proximal clip 16 are closed to hold the valve leaflet.

Due to the inevitable tolerance problems of the manufacturing process, there may be situations where the length of the clamping rod 12 is insufficient, resulting in the sliding plate 1841 not moving from the axial guide groove 3473 to the radial guide groove 3471 to generate an audible feedback when the valve leaflets are clamped closed by the distal clamp 14 and the proximal clamp 16. However, the operator must confirm whether distal jaw 14 and proximal jaw 16 are closed based on audible feedback. Thus, to hear the audible feedback, the operator may force the operating member 1843 to move proximally. In the present application, the clamping push rod 12 and the sliding member 182 are elastically connected through the elastic mechanism 19, and the elastic mechanism 19 is compressed to provide a space, so that when the length of the clamping push rod 12 is insufficient, the sliding plate 1841 can be driven by the operating member 1843 to move from the axial guide groove 3473 to the radial guide groove 3471 to generate an acoustic feedback, thereby preventing the valve leaflet from being pinched by the distal collet 14 and the proximal collet 16 excessively and being injured.

In the present embodiment, the elastic mechanism 19 includes the first link 191 and the elastic member 193. The first connecting member 191 is movably connected to the clamping mechanism 18, and particularly movably connected to the sliding member 182 of the clamping mechanism 18. The distal end of the first connector 191 is fixedly connected to the proximal end of the holding push rod 12. The proximal end of the clamping ram 12 abuts the clamping actuator 18, and in particular the slide 182 of the clamping actuator 18. The elastic element 193 is sleeved outside the first connector 191 and located between the proximal end of the first connector 191 and the clamping operating mechanism 18.

Specifically, the first connector 191 includes a main body 1911 and a flange 1913 disposed at a proximal end of the main body 1911. The main body 1911 is movably inserted into the clamping operation mechanism 18, and particularly movably inserted into the sliding member 182 of the clamping operation mechanism 18. The distal end of the body 1911 is fixedly attached to the proximal end of the clamping ram 12. The elastic element 193 is sleeved outside the main body 1911, and the elastic element 193 is located between the protruding edge 1913 and the clamping operation mechanism 18. The proximal end of the holding pushrod 12 is received in the pushrod mounting hole 1822, the main body 1911 and the elastic element 193 are partially received in the pushrod mounting hole 1822, and the proximal end of the holding pushrod 12 is fixedly connected to the main body 1911 and abuts against the sliding member 182 to be held in the pushrod mounting hole 1822. Due to the presence of ledge 1913, slide 182 is able to compress resilient member 193 when moving from the distal end to the proximal end, such that slide plate 1841 is able to be moved by operating member 1843 from axial guide slot 3473 to radial guide slot 3471 to generate an audible feedback.

Further, the elastic mechanism 17 further comprises a second link 194 for receiving the proximal end of the holding rod 12. The second linking member 194 is fixedly connected between the distal end of the main body 1911 and the proximal end of the clamping rod 12, i.e. the distal end of the main body 1911 is fixedly connected with the second linking member 194, and the proximal end of the clamping rod 12 is fixedly connected with the second linking member 194 173. Specifically, the distal end of the first connector 191, the proximal end of the second connector 194 and the clamping rod 12 are each provided with at least one connecting hole, and the three can be fixedly connected by a screw or a rivet, and in the example of fig. 12, the three are fixedly connected by a screw. The proximal end of the clamping push rod 12 is arranged in the accommodating groove of the second connecting piece 194, and the screw passes through the clamping push rod 12, the second connecting piece 194 and the first connecting piece 191 in sequence so as to fixedly connect the clamping push rod 12, the second connecting piece 194 and the first connecting piece 191.

In another embodiment, the inner surface of the push handle 34 is provided with a baffle (not shown). The elastic mechanism 17 includes a first connecting member movably connected to the clamping mechanism 18, and specifically movably connected to the sliding member 182 of the clamping mechanism 18. The first connecting piece comprises an elastic part and a connecting part. The radial dimension of the elastic part is larger than that of the connecting part, the connecting part is fixedly connected with the near end of the clamping push rod 12, and the near end of the clamping push rod 12 abuts against the clamping operating mechanism 18, specifically against the sliding piece 182 of the clamping operating mechanism 18. The two ends of the elastic part respectively support the sliding part 182 and the baffle of the clamping operating mechanism 18.

Specifically, the proximal end of the clamping push rod 12 is received in the push rod receiving hole 1822, the connecting portion of the first connecting member is received in the push rod receiving hole 1822, and the proximal end of the clamping push rod 12 is fixedly connected to the connecting portion and abuts against the sliding member 182 to be retained in the push rod receiving hole 1822. The elastic portion of the first connecting member is located outside the push rod mounting hole 1822 and abuts against the sliding member 182. Due to the presence of the blocking plate, the sliding member 182 can compress the elastic portion of the first connecting member when moving from the distal end to the proximal end, so that the sliding plate 1841 can be moved from the axial guide groove 3473 to the radial guide groove 3471 by the operating member 1843 to generate the acoustic feedback.

Referring again to fig. 4, 9, 13-16, the puncturing device 20 extends through the lumen of the pushing handle 34 in the axial direction of the pushing handle 34 and is movably inserted into the pushing catheter 32. The puncture device 20 includes a puncture plunger 22 and a puncture needle 24 disposed at a distal end of the puncture plunger 22.

In this embodiment, the positions of two fixing cavities 144 formed in the holding surface of distal cartridge 14 correspond to the positions of two puncture needles 24, respectively. Thus, two fasteners 64 of suture 60 are each received in distal cartridge 14, and the proximal end of each fastener 64 corresponds to one of piercing needles 24. The puncture needle 24 can be coupled to the anchors 64 of the suture 60 after puncturing the leaflets to pull the suture body 62 proximally. Piercing needle 24 forms a removably secured or non-removably secured connection with retainer 64, such as a threaded connection, an adhesive connection, a friction connection through a roughened surface, an interference fit, or a snap-fit connection. The shape of the fixing member 64 is matched with different connection modes, specifically, the outer part of the fixing member 64 is generally cylindrical, and the cross section shape can be various shapes such as circle, ellipse, polygon and the like, preferably circle or ellipse; the interior surface of the mount 64 is provided with a groove or hole and the distal end of the piercing needle 24 is provided with at least one tooth or at least one bead for forming an interference fit or snap-fit connection with the mount 64. In the illustrated example, the retainer 64 is cylindrical and has three radially extending grooves on its inner surface for engaging with the teeth or ridges on the needle 24.

The puncturing device 20 also includes a puncturing handle 26 coupled to the proximal end of the puncturing push rod 22. The proximal end of the pushing handle 34 is provided with a through hole for the puncture handle 26 of the puncture device 20 to pass through, and the size of the through hole is matched with that of the puncture handle 26. The piercing handle 26 is located partially within the lumen of the push handle 34 and partially outside the push handle 34. The proximal end of the piercing push rod 22 extends proximally out of the pusher catheter 32 and is connected to the piercing handle 26. The axial movement of the puncture handle 26 drives the puncture push rod 22 to move axially along the push catheter 32, thereby driving the puncture needle 24 to puncture distally or retract proximally. After the valve leaflet is held by the holding device 10, the puncture needle 24 can be driven by the puncture handle 26 to puncture the valve leaflet and connect with the fixing element 64 of the suture thread 60, the puncture needle 24 and the suture thread 60 are connected into a whole through the fixing element 64, the suture thread 60 is not easy to be separated from the puncture needle 24, and an operator can conveniently and quickly pull one end or two ends of the suture thread 60 connected with the fixing element 64 to a preset position of the ventricular wall or papillary muscle.

The puncturing device 20 also includes a safety 28. The safety element 28 is movably sleeved outside the puncture handle 26 and movably penetrates through the push handle 34. Safety 28 serves to lock piercing handle 26 to limit axial movement of piercing handle 26 to avoid operator mis-triggering of piercing handle 26 when piercing is not desired. In this embodiment, the safety element 28 and the puncture handle 26 can interfere with each other to lock the puncture handle 26, the push handle 34 is provided with a mounting groove 3422 (as shown in fig. 9 and 10) penetrating the inner and outer surfaces, and the safety element 28 is inserted into the mounting groove 3422. The inner surface of push handle 34 is provided with a support 346 for supporting piercing handle 26 and piercing plunger 22 so that the height of piercing handle 26 within the lumen of push handle 34 is fixed. The support member 346 is provided with a catch 3462 for receiving a portion of the safety member 28.

Referring to fig. 17, the safety element 28 is in an inverted convex shape as a whole, the safety element 28 includes a pressing portion 282 and a connecting portion 284, and the pressing portion 282 is used for being pressed by an operator. Connecting portion 284 includes first connecting portion 2842 and second connecting portion 2844 connected, and the radial dimension of first connecting portion 2842 is less than the radial dimension of second connecting portion 2844, first connecting portion 2842 and draw-in groove 3462 sliding connection. The pressing portion 282 connects one end of the second connecting portion 2844 away from the first connecting portion 2842. When the puncture handle 26 and the safety element 28 are locked, the pressing portion 282 is pressed to move the safety element 28 toward the bottom surface of the notch 3462, and the first connecting portion 2842 is filled in the notch 3462, so that the lock between the safety element 28 and the puncture handle 26 can be released.

The first connecting portion 2842 has a first receiving groove 281, the second connecting portion 2844 has a second receiving groove 283 communicating with the first receiving groove 281, the radial space of the second receiving groove 283 is larger than the radial space of the first receiving groove 281, and the piercing handle 26 movably penetrates the second receiving groove 283 and is in clearance fit with the second receiving groove 283. The puncture handle 26 is arranged in the safety element 28 in a penetrating way to be matched with the safety element 28, so that the matching space of the puncture handle and the safety element is reduced, and the size reduction of the valve suturing device 100 is facilitated.

More specifically, referring to fig. 16 again, an interference portion 262 is disposed on a side of the puncturing handle 26 facing the locking groove 3462, and a first protrusion 2622 and a shaft shoulder 2623 are recessed on two sides of the interference portion 262. When the first protrusion 2622 is inserted into the first receiving groove 281, the shaft shoulder 2623 abuts against the first connecting portion 2842 to prevent the axial movement of the puncture handle 26, so that the safety element 28 locks the puncture handle 26, that is, the safety element 28 and the puncture handle 26 are in a locked state. In this embodiment, the entire radial dimension of the puncture handle 26 is matched with the radial dimension of the second receiving groove 283. When the first protrusion 2622 is disposed in the second receiving groove 283, the shaft shoulder 2623 is also disposed in the second receiving groove 283, the shaft shoulder 2623 does not abut against the first connecting portion 2842 and the second connecting portion 2844, and the puncturing handle 26 can move relative to the safety element 28 along the axial direction in the second receiving groove 283, i.e. the safety element 28 and the puncturing handle 26 are in an unlocked state.

Referring to fig. 13 and 17 again, a sliding groove 264 is further disposed on a side of the puncturing handle 26 opposite to the locking groove 3462, that is, the sliding groove 264 is disposed on a side of the puncturing handle 26 facing the pressing portion 282, the second connecting portion 2844 is further provided with a third receiving groove 285, and the third receiving groove 285 is communicated with an end of the second receiving groove 283 away from the first receiving groove 281. The inner surface of the third receiving groove 285 is provided with a second protruding block 2822, and when the puncturing handle 26 is located in the second receiving groove 283 and the third receiving groove 285, at least a portion of the second protruding block 2822 is received in the sliding groove 264. When the puncturing handle 26 moves relative to the safety element 28 along the axial direction, the second protrusion 2822 can move along the sliding groove 264 to guide the movement of the puncturing handle 26 relative to the safety element 28, so that the smoothness and stability of the movement of the puncturing handle 26 relative to the safety element 28 are improved. In this embodiment, the radial space of the third accommodating groove 285 is larger than the radial space of the second accommodating groove 283. It can be understood that the radial space of the third receiving groove 285 may be smaller than or equal to the radial space of the second receiving groove 283, so as to ensure that the second protrusion 2822 can be inserted into the sliding groove 264. Of course, the third receiving groove 285 and the second bump 2822 may be omitted.

When the safety element 28 locks the puncture handle 26, the pressing portion 282 is accommodated in the mounting groove 3422, and the pressing portion 282 can be forced to drive the safety element 28 to move toward the bottom of the locking groove 3462. In this embodiment, when the safety element 28 and the puncture handle 26 are in the locked state, the pressing portion 282 fills the mounting groove 3422 and the surface of the pressing portion 282 away from the clamping groove 3462 is substantially flush with the outer surface of the pushing handle 34, the first connecting portion 2842 is clamped in the clamping groove 3462 and the surface of the first connecting portion 2842 facing the bottom surface of the clamping groove 3462 is at a certain distance from the bottom surface of the clamping groove 3462. At this time, the first protrusion 2622 is located in the first receiving groove 281, and the first connection portion 2842 and the shaft shoulder 2623 block the puncturing handle 26 from being pushed and moved to the distal end.

When the valve suturing device 100 needs the puncture device 20 to puncture, the pressing portion 282 is pressed and forced to move toward the notch 3462, the first connecting portion 2842 fills the notch 3462, and the surface of the first connecting portion 2842 facing the bottom surface of the notch 3462 contacts the bottom surface of the notch 3462. At this time, the first protrusion 2622 is separated from the first receiving groove 281, the puncturing handle 26 is integrally located in the second receiving groove 283 and the third receiving groove 281, the puncturing handle 26 can be pushed and moved along the axial direction, and the second protrusion 2822 slides in the sliding groove 264, so as to ensure the pushing stability of the puncturing handle 26.

Referring again to fig. 4 and 8, the detection device 50 is used to detect whether a leaflet is clamped between the distal collet 14 and the proximal collet 16. The probing apparatus 50 includes at least one probe 52 and a probe steering mechanism 54 coupled to a proximal end of each probe 52. The probe 52 is movably mounted through the lumen of the pusher handle 54 and the pusher catheter 32 for detecting whether the holding device 10 is holding the valve leaflets and the clamping effect on the leaflets. The stylet handle 54 is mounted to the push handle 34 and is movable relative to the push handle 34 for driving the stylet 52 to extend (move distally) the push catheter 32 or to retract (move proximally) the push catheter 32. In the present embodiment, the probe device 50 includes two probes 52, the two probes 52 are arranged in parallel, and the distance between the two probes 52 and the clamping pusher 12 is substantially equal.

The axial length of the stylet 52 is preferably greater than the axial length of the push catheter 32. The probe 52 is movably mounted in the pusher catheter 32. The gripping surface of the proximal collet 16 is provided with a stylet outlet 162 to facilitate extension of the distal end of the stylet 52 from the pusher catheter through the stylet outlet 162. Correspondingly, the gripping surface of distal cartridge 14 defines a probe receiving cavity 146 opposite probe outlet 162 for receiving the distal end of probe 52. When proximal jaw 16 is closed with distal jaw 14, the distal end of stylet 52 extends from stylet outlet 162 and is received in stylet receiving cavity 146.

The probe 52 includes a probe body having a length, which may be a solid or hollow structure. The probe body may be made of a metallic material, a polymer material, or a metal-polymer material. For example, the probe body can be a solid rod-shaped or hollow tubular structure with a single-layer or multi-layer composite structure, and can also be formed by winding a single wire or a plurality of wires.

When the proximal clip 16 and the distal clip 14 are closed, if the valve leaflet is clamped between the proximal clip 16 and the distal clip 14 and the edge of the valve leaflet contacts the clamping push rod 12, the distal end of the probe 52 is blocked by the valve leaflet after penetrating out of the clamping surface of the proximal clip 16 and can not advance further to the distal end, which indicates that the valve leaflet is clamped well and can be punctured. In addition, the distal end of the probe 52, when blocked by the leaflets from entering the probe-receiving cavity, also demonstrates a relatively fixed position between the leaflet edges and the suture body 62, which enhances treatment. Therefore, the clamping effect of the valve leaflets can be effectively detected by the probe 52 with a mechanical structure, and the instrument has a simple structure and is convenient to operate.

Referring to fig. 9, 13 and 14 again, the probe manipulating mechanism 54 further includes a sliding member 542 fixedly connected to the proximal end of the probe 52, and the sliding member 542 is axially slidably disposed on the pushing handle 34. The slide member 542 drives the probe 52 to move in the axial direction while sliding axially.

In the present embodiment, the number of probes 52 is two, and the number of sliders 542 is two corresponding to the number of probes 52. The inner surface of the second housing 344 of the push handle 34 is provided with two slide grooves 3441 (shown in fig. 9) symmetrical about the central axis of the push handle 34, and each slide member 542 is axially movable in the corresponding slide groove 3441. The first housing 342 further has two control through slots 3426 corresponding to the two sliding slots 3441, and the probe control mechanism 54 further includes a control member 544 disposed on the sliding member 542, the control member 544 is inserted into the control through slot 3426, and the control member 544 is used for driving the sliding member 542 to slide along the axial direction of the pushing handle 34. The two control members 544 are respectively exposed from the two control through grooves 3426 and clamped on the outer surface of the first housing 342. Manipulation channel 3426 may function to limit the distance probe manipulation mechanism 54 may move in an axial direction. The proximal end of each probe 52 is fixedly connected to the corresponding sliding member 542, and an operator controls the operation member 544 in the axial direction to drive the sliding member 542 to move in the axial direction, so as to drive the probe 52 to pass through the push catheter 32 or retract the probe 52 into the push catheter 32.

The manipulating member 544 is provided with an indicating portion 5442 (as shown in fig. 15) on a side of the central axis of the pushing handle 34 in the radial direction, and the outer surface of the first casing 342 is provided with a mark 341 (as shown in fig. 10) between the two manipulating through grooves 3426. In this embodiment, the mark 341 includes a first mark 3411 and a second mark 3412, where the first mark 3411 and the second mark 3412 are in two different colors, for example, the first mark 3411 is red and the second mark 3412 is green. Controlling the two manipulating members 544 to move distally, as shown in fig. 26a, 26b, and 26c, when at least one indicating part 5442 points to the first mark 3411, it indicates that the leaflet clipping effect is poor; as shown in fig. 27, when both the indicating portions 5442 point to the second mark 3412, it is described that the leaflet clipping effect is good. It is to be understood that the first mark 3411 and the second mark 3412 are not limited to colors, and the first mark 3411 and the second mark 3412 may be distinguished by other forms, such as different letters, etc.

Referring to fig. 13 and 14 again, the probe manipulating mechanism 54 further includes a guide rail 546 extending in a radial direction, the guide rail 546 is disposed on the sliding member 542, and the manipulating member 544 is slidably connected to the guide rail 546. Specifically, the guide rail 546 has a guide slot 5460, and the operating member 544 can be engaged with the guide slot 5460 of the guide rail 546 and can move in the radial direction. The manipulation channel 3426 is L-shaped and includes an axial channel 3427 and a radial channel 3428 (shown in fig. 10) connecting proximal ends of the axial channel 3427. The radial groove 3428 is provided for the operation member 544 to move in a radial direction, when the operation member 544 is located in the radial groove 3428, the probe 52 is completely accommodated in the push catheter 32, and at this time, the operation member 544 cannot drive the sliding member 542 to move in an axial direction, so that the probe 52 can be kept accommodated in the push catheter 32, and misoperation during an operation process can be avoided.

Further, the inner surface of the second housing 344 of the pushing handle 34 is provided with a positioning slot 349 (as shown in fig. 10), and the probe operating mechanism 54 further includes a positioning member 35 and a positioning rod 548. The positioning element 35 is clamped in the positioning slot 349, the positioning element 35 is provided with a positioning hole 352 for the positioning rod 548 to pass through, and the distal end of the positioning rod 548 is fixed to the sliding element 542. The probe manipulating mechanism 54 further includes a pushing elastic member (e.g., a spring, not shown) through which the positioning rod 548 is inserted, wherein a proximal end of the pushing elastic member is received in the positioning hole 352 and a distal end thereof abuts against the pushing handle 34. When the control member 544 is in the radial groove 3428, the probe 52 is fully located in the push catheter 32, and the positioning member 35 compresses the push resilient member; when the control member 544 is moved from the radial groove 3428 to the axial groove 3427, the distal end of the probe 52 is extended from the distal end of the pusher catheter 32 by the elastic force of the pusher elastic member.

More specifically, in the initial state, the manipulation member 544 is in the radial groove 3428, the push spring on the positioning rod 548 is compressed, and the probe 52 is received in the push catheter 32. When the manipulating member 544 is moved from the radial groove 3427 to the axial groove 3428, the distal end of the probe 52 can be directly pushed out of the pushing catheter 32 due to the elastic force generated by the pushing elastic member on the positioning rod 548 restoring from the compressed state to the natural state.

Referring to fig. 7b, 18 and 19, to further enhance clamping, the valve stapler 100 further comprises a clamping aid 40. Grip assist apparatus 40 includes at least one grip assist arm 42 (only one shown by way of example in fig. 18) and a grip assist member 44 disposed at a distal end of grip assist arm 42. A grasping aid arm 42 is movably inserted through the push catheter 32. The grasping aid 42 is made of a resilient and/or flexible material, the grasping aid arm 42 being adapted to urge the grasping aid 42 attached thereto out of the distal end of the push catheter 32 or the distal end of the grasping device 10, the grasping aid 42 being adapted to cooperate with the grasping device 10 to grasp a leaflet.

Further, referring to fig. 9 and 18 again, the auxiliary clamping device 40 further includes an auxiliary operating mechanism 46 connected to the proximal end of the auxiliary clamping arm 42, and the auxiliary operating mechanism 46 is disposed on the pushing handle 34. The proximal end of the grasping auxiliary arm 42 passes out of the pusher catheter 32 and provides an auxiliary operating mechanism 46. The gripping surface of the proximal cartridge 16, the side of the pusher catheter 32, or the side of the proximal cartridge 16 is provided with an auxiliary element outlet 321. Thus, the auxiliary operating mechanism 46 can drive the grasping aid arm 42 to push the grasping aid 44 out of the distal end of the push catheter 32 or the distal end of the grasping device 10.

The push catheter 32 has an auxiliary arm accommodating chamber 328 formed therein in the axial direction. Before the puncture device 20 of the valve stapler 100 punctures, the holding auxiliary 44 and the holding auxiliary arm 42 are both received in the auxiliary arm receiving cavity 328. In this embodiment, the side of the proximal cartridge 16 is provided with an auxiliary outlet 321 (shown in fig. 9), and the auxiliary outlet 321 is communicated with the auxiliary arm receiving cavity 328. The operator pushes the auxiliary manipulator 46 distally, and the auxiliary grasping arm 42 can be driven to push the auxiliary grasping member 44 out of the auxiliary member outlet 321, thereby supporting the lower surface of the leaflet, stabilizing the pulsating leaflet, reducing the amplitude of the leaflet's motion, and cooperating with the grasping device 10 to grasp and fix the leaflet.

The clamp assist arm 42 is a rod or tube-like structure having an axial length and a stiffness or rigidity to provide support and pushability. The auxiliary holding arm 42 may be made of a single-layer or multi-layer composite structure hollow or solid metal rod or a polymer material rod, or may be made of a single wire or a plurality of wires by winding. The grasping auxiliary arm 42 may be made of a metal material, a polymer material, or a metal-polymer composite material.

Referring to fig. 20, the holding aid 44 is supported on the lower surface of the leaflet 200 and cooperates with the holding device 10 to hold the leaflet 200. Since the clamping aid 44 is made of a resilient and/or flexible material, it can adapt to the anatomy of the leaflet 200 and the amplitude of movement of the leaflet 200 and avoid damage to the leaflet 200. The elastic material is preferably a shape memory material. The clamping aid 44 may be made of a metallic material, a polymeric material, or a metal-polymer composite material. In this embodiment, the holding aid 44 is made of elastic nickel titanium alloy with shape memory.

To facilitate being pushed through the push conduit 32, the gripping aid 44 includes a compressed state and an extended state in a natural state. When the clamping auxiliary member 44 is in the compressed state, it is received in the auxiliary arm receiving cavity 328 of the pushing catheter 22 and pushed. When the grasping aid 44 extends from the aid outlet 321, it transitions to an extended state and can support the lower surface of the leaflet 200, stabilizing the beating leaflet 200. In the present embodiment, the holding aid 44 has a net structure formed by weaving a plurality of wires. The net structure can be further subjected to heat setting treatment to form spherical, columnar, nested, oblate and other structures. Preferably, the clamping aids 44 are woven mesh-like structures that, in a compressed state, are radially compressed and received in the auxiliary arm receiving cavities 328; in the expanded state, the braided mesh balloon is pushed out of the auxiliary element outlet 321 to radially expand from an expanded shape into a balloon.

The contact surface of the clamping auxiliary part 44 with a larger diameter and the valve leaflet 200 is the plane where the clamping auxiliary part 44 is located, so that the contact area between the clamping auxiliary device 40 and the valve leaflet is larger, the valve leaflet can be better attached, and the support of the clamping auxiliary device 40 to the valve leaflet is improved. The holding auxiliary member 44 has a smooth outer shape, and the distal end of the holding auxiliary member 44 may be formed into a smooth rounded head by laser spot welding or the like without defects such as burrs, edges, or edges and corners. It is to be understood that the clamping auxiliary element 44 is not limited to be a mesh structure, and in other embodiments, the clamping auxiliary element 44 may further include one support rod or a deformation structure composed of a plurality of support rods, the deformation structure may be an open-type branched structure, an umbrella-type structure or a closed-loop structure composed of a plurality of support rods, and the clamping auxiliary element 44 may be supported on the lower surface of the leaflet and cooperate with the clamping device 10 to clamp the leaflet.

Referring again to fig. 9 and 18, the auxiliary operating mechanism 46 is disposed on the pushing handle 34. Specifically, the inner surface of the second housing 344 of the push handle 34 is provided with a sliding groove 3448 (as shown in fig. 9), and the first housing 342 is provided with a corresponding manipulation through groove 3424. The auxiliary operating mechanism 46 includes a slide 462 and an operating member 464 provided on the slide 462. The proximal end of the auxiliary holding arm 42 is fixedly connected to the sliding member 462, the sliding member 462 is axially movable in the sliding groove 3448, and the operating member 464 is exposed from the operating through groove 3424 and is engaged with the outer surface of the first housing 342. The manipulation channel 3424 may function to limit the moving distance of the auxiliary manipulation mechanism 46 in the axial direction. Axial movement of the operating member 464 along the operating channel 3424 causes the sliding member 462 to move axially in the sliding channel 3448, thereby pushing the auxiliary clamping arm 42 to cause the auxiliary clamping member 44 to pass from the auxiliary arm receiving cavity 328 through the auxiliary member outlet 321 or to retract the auxiliary clamping member 44 into the auxiliary arm receiving cavity 328.

Further, the auxiliary operating mechanism 46 further includes a guide rail 466, the guide rail 466 is disposed on the sliding member 462, the guide rail 466 has a guide rail groove, and the operating member 464 is capable of being engaged with the guide rail groove to move in the radial direction. The manipulation channel 3424 is substantially Z-shaped and includes an axial channel and a radial channel connecting two ends of the axial channel. The radial through slot 3424 is provided for the operating member 464 to move in the radial direction, and when the operating member 464 is located in the radial through slot 3424, the operating member 464 cannot drive the sliding member 462 to move in the axial direction, so as to avoid the operator from moving the operating member 464 in the axial direction by mistake when the holding auxiliary member 44 is required to be kept in the auxiliary arm receiving cavity 328 or the holding auxiliary member 44 is passed out from the auxiliary member outlet 321.

Referring to FIG. 21, the pusher catheter 32 has a piercing plunger channel 322, a retaining plunger channel 324, and a stylet channel 326 disposed therein along an axial direction. The clamping plunger 12 is inserted into the clamping plunger channel 324 of the pusher catheter 32, the piercing plunger 22 is inserted into the piercing plunger channel 322 of the pusher catheter 32, and the stylet 52 is inserted into the stylet channel 326 of the pusher catheter 32, so as to ensure that the axial directions of the clamping plunger 12, the piercing plunger 22, and the stylet 52 are all substantially parallel to the axial direction of the pusher catheter 32. A gripping pusher channel 324 is provided on one side of the pusher catheter 32 and two piercing pusher channels 322 are provided on the other side of the pusher catheter 32. The probe channel 326 is disposed between the clamp ram channel 324 and the piercing ram channel 322, and the distance between the probe channel 326 and the clamp ram channel 324 is less than the distance between the probe channel 326 and the piercing ram channel 322. It will be appreciated that when an auxiliary arm receiving cavity 328 is also provided in the push catheter 32, the auxiliary arm receiving cavity 328 is disposed between the clamping push rod channel 324 and the piercing push rod channel 322, the probe channel 326 is disposed between the clamping push rod channel 324 and the auxiliary arm receiving cavity 328, and the distance between the probe channel 326 and the clamping push rod channel 324 is less than the distance between the probe channel 326 and the piercing push rod channel 322.

The push catheter 32 may be a multi-lumen tube formed integrally, or the outer tube and the inner tube may be fixed together to form the push catheter 32 as a unitary structure. The pusher catheter 32 may be made of a biocompatible polymeric material (e.g., polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile butadiene styrene ABS, nylon elastomer Pebax, or polyurethane PU), a metallic material (e.g., stainless steel or nickel titanium alloy), or a metal-polymer composite.

The clamping operation mechanism 18, the auxiliary operation mechanism 46 and the probe operation mechanism 54 are all arranged on the pushing handle 34, and sequentially comprise the clamping operation mechanism 18, the auxiliary operation mechanism 46 and the probe operation mechanism from the far end to the near end. The sliding member 182 has an axial through hole for the auxiliary clamping arm 42, the probe 52 and the puncture push rod 22 to pass through. The sliding element 462 is provided with a through groove and a through hole along the axial direction on both sides of the central axis of the pushing handle 34 for the probe 52 and the puncture push rod 22 to pass through. The slider 542 is provided with a support portion 5422 (shown in fig. 15) radially toward the central axis of the push handle 34, the support portion 5422 and the support member 346 being at the same height to jointly support the puncture push rod 22 and the puncture handle 26.

Referring again to FIG. 8, the pushing device 30 further includes a sealing tube 36 connected to the pushing catheter 32, the sealing tube 36 is disposed in the inner cavity of the pushing handle 34 and connected to the proximal end of the pushing catheter 32, and the puncturing device 20, the probe 52, the holding rod and the holding auxiliary arm are movably inserted into the sealing tube 36. In the present embodiment, the sealing tube 36 is provided with a luer fitting 362 for connecting an exhaust pipe (not shown) to exhaust. The sealing tube 36 is located in the inner cavity formed between the first housing 342 and the second housing 344, and the distal end side of the pushing handle 34 is opened with a mounting hole 3440 for mounting the luer 362. The distal outer surface of the sealing tube 36 is threaded to threadably engage an internally threaded mounting member 38 to fixedly attach the pusher catheter 32 to the pusher handle 34.

The distal end of the sealing tube 36 is connected to the proximal end of the pushing catheter 32, the proximal end of the sealing tube 36 is open and filled with at least one sealing member 37, and the sealing member 37 is provided with a through hole (not shown) for the puncture device 20, the probe 52, the holding push rod and the holding auxiliary arm to pass through. In the present embodiment, the sealing member 37 includes a sealing silicone. The seal 37 is secured by a retaining nut 33 threadably coupled to the proximal end of the seal tube 36. The push conduit 32 is provided with a plurality of through cavities or channels spaced apart from one another in the axial direction, and correspondingly, the sealing member 37 is also provided with a plurality of through holes spaced apart from one another. It should be understood that the material of the seal 37 is not limited in the present application, and the connection method between the seal 37 and the seal tube 36 is not limited, and for example, in other embodiments, the seal may be bonded by glue or may be engaged.

The following is a brief description of the procedure of the valve suturing device 100 according to the present embodiment, taking the chordae implantation performed by the mitral valve posterior leaflet as an example.

First, referring to fig. 22, the valve stapler 100 is advanced into the left ventricle, and the valve stapler 100 is further advanced until the distal cartridge 14 and the proximal cartridge 16 are both located in the left atrium.

Second, referring to fig. 23, operating member 1841 is moved distally to push holding rod 12 distally so that proximal clip 16 is separated from distal clip 14, thereby forming a leaflet receiving space between proximal clip 16 and distal clip 14.

Third, referring to fig. 24, the manipulating member 464 is controlled to move distally to drive the holding auxiliary arm 42 to push the holding auxiliary member 44 out of the auxiliary member outlet 321, at which time the holding auxiliary member 44 is supported on the lower surface of the leaflet to help stabilize the pulsating leaflet, the relative position between the operating member 1841 and the manipulating member 464 is kept unchanged, the whole instrument is slowly moved proximally until the leaflet enters the leaflet receiving space formed between the proximal collet 16 and the distal collet 14, and the holding auxiliary member 44 can provide a certain supporting force to the leaflet.

In a fourth step, referring to FIG. 25, the distal end of the valve stapler 100 is moved slightly until the leaflet edge contacts the retaining pusher 12, whereupon the operating member 1841 is withdrawn proximally, driving the distal collet 14 toward the proximal collet 16 until the two close and the leaflet is retained. If the operator finds the leaflets not being effectively gripped, the relative positions of the distal jaw 14 and the proximal jaw 16 can be fine-tuned to create a distance therebetween, and the relative position of the gripping pushrod 12 and the leaflets can be adjusted. During adjustment, the leaflet is prevented from slipping out of the holding device 10 because the holding assist device 40 under the leaflet has some support to the leaflet.

Fifthly, keeping the position of the pushing handle 34 unchanged, and respectively controlling the two manipulating pieces 544 to move distally to drive the probe 52 to move distally along the axial direction of the pushing catheter 32; as shown in fig. 26 a-26 c, if the leaflet is poorly held, i.e., the leaflet does not completely cover the probe outlet 162 on the holding surface of the proximal cartridge 16, the distal end of the probe 52 can extend from the probe outlet 162 into the probe-receiving cavity 146 of the distal cartridge 14, and the second to fourth steps are repeated to re-hold the leaflet; as shown in fig. 27, if the valve leaflet is clamped well, i.e. the valve leaflet completely covers the probe outlet 162 on the clamping surface of the proximal clamping head 16, the distal end of the probe 52 cannot extend out of the probe outlet 162 and enter the probe receiving cavity 146 of the distal clamping head 14, and then the two manipulating members 544 are respectively operated to move proximally into the radial grooves 3428 of the manipulating channels 3426 to drive the probe 52 to retract to the pushing catheter 32 for subsequent operation.

Sixth, pressing on press 282 of safety element 28 unlocks the locked position of puncture handle 26, as shown in fig. 28, and the puncture handle 26 is pushed distally, driving puncture needle 24 distally until puncture needle 24 passes through leaflets 200 and forms a secure connection with anchors 64 of suture 60, as shown in fig. 30.

Seventh, referring to fig. 31 and 32, the puncture handle 26 is withdrawn, so that the puncture needle 24 carries the fixing member 64 of the suture 60 and the suture body 62 connected to the fixing member 64 through the leaflet 200 in sequence.

Eighth, the puncture handle 26 is further retracted until the fixing member 64 is withdrawn from the proximal end of the pushing handle 34, and then the operation member 464 is retracted, so that the holding auxiliary member 44 is retracted into the auxiliary arm accommodating cavity 328, the entire valve suturing device 100 is withdrawn, and the length of the suture line body 62 remaining in the heart is adjusted, so that the two ends of the suture line body 62 are respectively fixed on the ventricular wall, thereby completing the implantation of the suture line 60 (as shown in fig. 33).

The foregoing is merely a preferred embodiment of the present application and is not intended to limit the present application in any way. Although the present application has been described with reference to the preferred embodiments, it is not intended to limit the present application. Those skilled in the art can now make numerous possible variations and modifications to the disclosed embodiments, or modify equivalents thereof, without departing from the scope of the disclosed embodiments. Therefore, any simple modification, equivalent change and modification of the above embodiments according to the technical essence of the present application are still within the protection scope of the technical solution of the present application.

Claims

1. A valve stapler, comprising:

a pusher device comprising a pusher catheter; and

clamping device, clamping device includes centre gripping push rod, near-end chuck, distal end chuck, centre gripping operating device and elastic mechanism, the dress is worn movably to the centre gripping push rod in the propelling movement pipe, the near-end chuck is located the distal end of propelling movement pipe, the distal end chuck is located the distal end of centre gripping push rod, elastic mechanism fixed connection the near-end of centre gripping push rod, centre gripping operating device swing joint the near-end of centre gripping push rod reaches elastic mechanism, centre gripping operating device drives the centre gripping push rod is made by far-end to near-end removal the distal end chuck with the near-end chuck is closed the back, centre gripping operating device compresses elastic mechanism makes centre gripping operating device for the centre gripping push rod takes place the displacement in order to send the sound feedback to the near-end.

2. The valve stapler of claim 1, further comprising a pushing handle disposed at a proximal end of the pushing catheter, wherein the clamping operating mechanism is disposed at the pushing handle, the elastic mechanism comprises a first connecting member and an elastic element, the first connecting member is movably connected to the clamping operating mechanism, a distal end of the first connecting member is fixedly connected to a proximal end of the clamping push rod, a proximal end of the clamping push rod abuts against the clamping operating mechanism, and the elastic element is sleeved outside the first connecting member and is located between the proximal end of the first connecting member and the clamping operating mechanism.

3. The valve suturing device of claim 2, wherein the first connecting member includes a main body and a protruding edge disposed at a proximal end of the main body, the main body is movably disposed in the clamping mechanism, a distal end of the main body is fixedly connected to a proximal end of the clamping push rod, the elastic member is sleeved outside the main body, and the elastic member is disposed between the protruding edge and the clamping mechanism.

4. The valve stapler of claim 3, wherein the resilient mechanism further comprises a second connector fixedly connected between the distal end of the body and the proximal end of the clamping pusher.

5. The valve suturing device according to claim 1, further comprising a pushing handle disposed at a proximal end of the pushing catheter, wherein the clamping operation mechanism is disposed at the pushing handle, a baffle is disposed on an inner surface of the pushing handle, the elastic mechanism comprises a first connecting member movably connected with the clamping operation mechanism, the first connecting member comprises an elastic portion and a connecting portion, a radial dimension of the elastic portion is larger than a radial dimension of the connecting portion, the connecting portion is fixedly connected with a proximal end of the clamping push rod, the proximal end of the clamping push rod abuts against the clamping operation mechanism, and two ends of the elastic portion respectively abut against the clamping operation mechanism and the baffle.

6. The valve suturing device according to claim 1, further comprising a pushing handle disposed at a proximal end of the pushing catheter, wherein the clamping operation mechanism is disposed at the pushing handle, a sliding groove is axially disposed on an inner surface of the pushing handle, the clamping operation mechanism comprises a connected sliding member and an operation assembly, the sliding member is slidably disposed in the sliding groove, the elastic mechanism is movably connected with the sliding member, the elastic mechanism is fixedly connected with a proximal end of the clamping push rod, the proximal end of the clamping push rod abuts against the sliding member, and the operation assembly drives the sliding member to axially slide along the sliding groove.

7. The valve stapler of claim 6, wherein the operating member is elastically connected to the sliding member, the pushing handle further has a guide groove on an inner surface thereof, the operating member is slidably disposed in the guide groove, the guide groove comprises a radial guide groove and an axial guide groove, the radial guide groove and the axial guide groove are connected, the axial guide groove is closer to a central axis of the pushing handle than the radial guide groove, the operating member is switchable between a natural state and a compressed state, and when the operating member moves from the axial guide groove to the radial guide groove, the operating member is switched from the compressed state to the natural state to impact the pushing handle to generate an acoustic feedback.

8. The valve stapler of claim 7, wherein the pushing handle further comprises an operating channel on a side surface thereof, the operating member comprises a sliding plate, an operating member and an elastic member, the sliding plate is connected to the operating member, the sliding plate is slidably disposed in the guiding channel, the operating member is engaged with the operating channel and exposed from the pushing handle, the elastic member is connected between the sliding member and the sliding plate, and the operating member impacts the pushing handle to generate an audible feedback when the elastic member is converted from the compressed state to the natural state.

9. The valve suturing device of claim 8, wherein the operating member includes an operating portion, a connecting portion and a feedback portion, the operating portion, the connecting portion and the feedback portion are sequentially connected, the connecting portion is disposed through the operating through groove, the operating portion is located outside the pushing handle, the feedback portion is accommodated in an inner cavity of the pushing handle, and when the elastic member is converted from the compressed state to the natural state, the feedback portion impacts an inner side surface of the pushing handle to generate sound feedback.

10. The valve stapler of claim 8, wherein the clamping mechanism further comprises a mounting rod connected between the sliding member and the operating member, and the elastic member is sleeved outside the mounting rod.

11. The valve stapler of claim 1, wherein the pushing device further comprises a sealing tube in communication with the pushing catheter, the sealing tube being located in the lumen of the pushing handle and connected to the proximal end of the pushing catheter, the clamping push rod being movably mounted in the sealing tube.

12. The valve stapler of claim 11, wherein a distal end of the sealing tube communicates with a proximal end of the pusher catheter, the proximal end of the sealing tube being open and filled with at least one seal, the seal being provided with a through hole for the clamping rod to pass through.

13. The valve stapler of claim 1, further comprising a puncture device movably mounted in the pusher catheter, wherein the puncture device comprises a puncture push rod and a puncture needle disposed at a distal end of the puncture push rod.

14. The valve stapler of claim 1, further comprising a probe device, wherein the probe device comprises at least one stylet movably mounted in the pusher catheter, wherein the gripping surface of the proximal cartridge defines a stylet outlet, wherein the gripping surface of the distal cartridge defines a stylet receiving cavity opposite the stylet outlet, and wherein when the distal cartridge is closed relative to the proximal cartridge, a distal end of the stylet protrudes from the stylet outlet and is received in the stylet receiving cavity.

15. The valve stapler of claim 1, further comprising a grasping aid, wherein the grasping aid comprises at least one grasping aid arm and a grasping aid provided at a distal end of the grasping aid arm, the grasping aid arm is movably inserted into the pushing conduit, the grasping aid is made of an elastic and/or flexible material, the grasping aid arm pushes the grasping aid connected thereto out of a distal end of the pushing conduit or a distal end of the grasping device, and the grasping aid cooperates with the grasping device to grasp the leaflet.