CN210871757U

CN210871757U - Clamp holder for valve leaflet repair

Info

Publication number: CN210871757U
Application number: CN201921243184.9U
Authority: CN
Inventors: 虞奇峰; 肖振昕; 秦涛
Original assignee: Shanghai Newmed Medical Co Ltd
Current assignee: Shanghai Newmed Medical Co Ltd
Priority date: 2019-08-02
Filing date: 2019-08-02
Publication date: 2020-06-30
Anticipated expiration: 2029-08-02

Abstract

The utility model relates to the technical field of medical equipment, a clamp holder for leaflet repair is disclosed. The utility model provides a holder for valve leaflet restoration, drive locking subassembly reciprocating motion through the push-pull actuating lever so that main part frame inserts or breaks away from first logical groove, make simultaneously that first clamp elastic sheet and second press from both sides tight shell fragment and can take place elastic deformation in order to press from both sides the tight position of treating on the valve leaflet, and after pressing from both sides tight shell fragment through first clamp elastic sheet and second and press from both sides tight shell fragment clamp valve leaflet, can also utilize the relative both sides wall restriction first clamp elastic sheet in first logical groove to outwards expand, guarantee to press from both sides the valve leaflet that is located between first clamp elastic sheet and the tight shell fragment of second clamp and can. The utility model provides a holder for valve leaflet restoration is less for current holder spare part, simple structure, and convenient operation has shortened the operation time, and the stability reinforcing of clamping of valve leaflet simultaneously.

Description

Clamp holder for valve leaflet repair

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a clamp holder is used in leaflet restoration.

Background

The heart has four valves, the valve between the left atrium and the left ventricle is the mitral valve, the valve between the right atrium and the right ventricle is the tricuspid valve, the valve between the aorta and the left ventricle is the aortic valve, and the valve between the pulmonary artery and the right ventricle is the pulmonary artery valve. A normal valve can maintain one-way flow of blood by opening and closing according to the pressure difference on each side, ensuring that the blood in the chamber is pumped out without backflow. A wide variety of diseases, such as rheumatic heart disease, and the disease of valves caused by endocarditis, are the impairment of the function of the valves, of which stenosis and regurgitation are common valvular diseases. Stenosis is a result of incomplete opening of the valve, resulting in obstructed blood flow, and thickening of the valve leaflets due to calcification is a common cause of stenosis. Regurgitation is caused by the inability of the leaflets to close completely, resulting in regurgitation into the chamber from which blood is pumped, and is primarily caused by annular dilation, leaflet prolapse, and resistance to leaflet movement.

There are two main therapeutic regimens for valvular diseases: valve replacement or valve repair. Compared with valve replacement, the valve repair utilizes the native valve, has less complications, quick recovery and no need of lifetime anticoagulation, and can better maintain the valve function. Thus, mitral or tricuspid valves are somewhat more effectively treated with valve repair.

At present, the improvement of valve regurgitation by repairing a diseased valve of a human body with a valve repair clamp is an important valve repair technology, wherein MitraClip is widely popularized clinically and has better clinical curative effect. The main principle is that prolapsed mitral valve leaflet/tricuspid leaflet and corresponding anterior leaflet or posterior leaflet are sutured together to form a suture at the middle point of the edge of the mitral valve with two holes, thereby reducing mitral regurgitation, and the blood flow flowing into the left ventricle is not influenced when the mitral valve is opened in diastole, but MitraClip still has the following problems: complex structure, difficult clamping of valve leaflets, long operation time and the like.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a leaflet repair that simple structure, convenient operation, stability are strong uses holder.

To achieve the purpose, the utility model adopts the following technical proposal:

a leaflet repair holder comprising:

the clamping assembly comprises a first clamping elastic sheet and a second clamping elastic sheet positioned on one side of the first clamping elastic sheet; the first clamping elastic sheet and the second clamping elastic sheet penetrate through the main body frame, and two ends of the first clamping elastic sheet and two ends of the second clamping elastic sheet extend out of the main body frame;

the locking assembly is provided with a first through groove;

the actuating rod can reciprocate relative to the main body frame along the axial direction of the actuating rod so that the main body frame is inserted into or separated from the first through groove, and meanwhile, the first clamping elastic sheet and the second clamping elastic sheet can elastically deform to clamp the to-be-clamped position on the valve leaflet.

As a preferable aspect of the above-described leaflet repair holder, the locking assembly is threadedly coupled to the actuating rod.

As an optimal technical scheme of the holder for repairing the valve leaflets, the locking assembly comprises a locking cap provided with a first through groove and an inner rod connected with the locking cap, an inner rod is provided with an internal thread hole at one end connected with the locking cap, one end of the actuating rod is provided with an external thread matched with the internal thread hole, and the actuating rod is detachably connected with the inner rod through the external thread and the matching of the internal thread hole.

As a preferred technical solution of the above holder for repairing valve leaflets, one end of the main body frame is provided with a second through groove, the first through groove and the second through groove have openings opposite to each other, a limiting post is provided on the bottom wall of the second through groove, the first clamping elastic sheet and the second clamping elastic sheet are sleeved on the limiting post, and both ends of the first clamping elastic sheet and the second clamping elastic sheet extend out of the second through groove.

As a preferable technical solution of the above holder for repairing a leaflet, in two opposite side walls of the second through groove, each side wall is provided with a limit boss pointing to the other side wall, and a minimum distance between the two limit bosses is smaller than a minimum width of the first clamping elastic sheet disposed in the second through groove.

As a preferable technical scheme of the holder for repairing the valve leaflets, the free end of the inner rod is provided with a second inverted tooth;

the free end of the inner rod penetrates through the main body frame and can enable the second inverted tooth to abut against one end, deviating from the second through groove, of the main body frame, or enable the second inverted tooth to be clamped between the inner rod and the main body frame.

As a preferable aspect of the above-described leaflet repair holder, the leaflet repair holder further includes:

the free end of the inner rod is in inserting connection with one end of the disengagement rod along the radial direction of the inner rod, and one end of the actuation rod penetrates through the disengagement rod and is in threaded connection with the locking assembly so that the inner rod and the disengagement rod are relatively fixed.

As a preferable technical solution of the above holder for repairing valve leaflets, a through hole for passing the inner rod is provided on the body frame, a sliding groove extending in the axial direction of the inner rod is provided on one of the outer wall of the inner rod or the inner wall of the through hole, and a protrusion engaged with the sliding groove is provided on the other.

the two ends of the first clamping elastic sheet in the length direction are respectively provided with a first traction hole, and the first traction wire penetrates through the traction holes and is connected to the locking assembly;

the two ends of the second clamping elastic sheet in the length direction are respectively provided with a second traction hole, and the traction steel wire is connected to the second traction holes through a conveying system.

As a preferable technical solution of the above-mentioned holder for repairing a leaflet, the surface of the first clamping spring and/or the second clamping spring is provided with an anti-slip layer so as to further enhance the clamping effect on the leaflet.

Meanwhile, the first clamping elastic sheet and the second clamping elastic sheet are made of shape memory materials, and the main body frame, the clamping assembly, the locking assembly and the actuating rod are made of biocompatible materials.

The utility model has the advantages that:

1. the gripper for repairing the valve leaflets provided by the utility model drives the locking component to reciprocate by pushing and pulling the actuating rod so as to enable the main body frame to be inserted into or separated from the first through groove, and simultaneously enables the first clamping elastic sheet and the second clamping elastic sheet to be elastically deformed so as to clamp the positions to be clamped on the valve leaflets, the whole process is simple to operate, and the valve leaflets can be rapidly clamped, so that the operation time is shortened;

2. the gripper for repairing the valve leaflets provided by the utility model utilizes the two opposite side walls of the first through groove to limit the outward expansion of the first clamping elastic sheet after the valve leaflets are clamped by the first clamping elastic sheet and the second clamping elastic sheet, so that the valve leaflets between the first clamping elastic sheet and the second clamping elastic sheet can not be separated, and the clamping stability is ensured;

3. on the whole, the utility model provides a clamp holder for leaflet restoration is less for current clamp holder spare part, simple structure, and low in production cost has reduced patient's medical expense.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required to be used in the description of the embodiments of the present invention will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the contents of the embodiments of the present invention and the drawings without creative efforts.

Fig. 1 is a schematic structural view illustrating an open state of a holder for leaflet repair according to an embodiment of the present invention;

fig. 2 is a first cross-sectional view of a leaflet repair holder of the present invention in an open state;

fig. 3 is a second sectional view of the leaflet repair holder of the present invention in an open state;

fig. 4 is a schematic structural view illustrating a closed state of a holder for leaflet repair according to an embodiment of the present invention;

fig. 5 is a cross-sectional view of a leaflet repair holder provided in an embodiment of the present invention in a closed state;

fig. 6 is a first schematic structural diagram of a main body frame according to an embodiment of the present invention;

fig. 7 is a schematic structural view of a first clamping spring according to an embodiment of the present invention;

fig. 8 is a schematic structural diagram of a main body frame according to an embodiment of the present invention;

fig. 9 is a schematic structural view of an inner rod according to an embodiment of the present invention;

fig. 10 is a schematic structural view of a release lever according to an embodiment of the present invention.

In the figure:

1. a main body frame; 11. a second through groove; 12. a limiting column; 13. a limiting boss; 14. perforating holes; 15. a chute;

2. a clamping assembly; 21. a first clamping spring sheet; 211. a first traction hole; 212. a splined bore; 22. a second clamping spring sheet; 221. a second traction hole; 222. a first pawl;

3. a locking assembly; 31. a locking cap; 311. a first through groove; 312. a third through groove; 32. an inner rod; 321. a groove; 322. a protrusion; 323. a second pawl;

4. an actuating lever;

5. a release lever; 51. and (4) a bump.

Detailed Description

In order to make the technical problem solved by the present invention, the technical solution adopted by the present invention and the technical effect achieved by the present invention clearer, the technical solution of the present invention will be further explained by combining the drawings and by means of the specific implementation manner. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting of the invention. It should be further noted that, for the convenience of description, only some but not all of the elements related to the present invention are shown in the drawings.

As shown in fig. 1 to 5, the present embodiment provides a holder for leaflet repair, which can be used for mitral valve regurgitation treatment and also for tricuspid valve regurgitation treatment, and the present embodiment takes mitral valve regurgitation treatment as an example. The gripper for repairing the mitral valve leaflet comprises a main body frame 1, a clamping assembly 2, a locking assembly 3 and an actuating rod 4, wherein the clamping assembly 2 comprises a first clamping elastic sheet 21 and a second clamping elastic sheet 22 which are distributed along a first direction (the direction of L1 shown in fig. 1), the first clamping elastic sheet 21 is positioned on one side of the second clamping elastic sheet 22, and the first clamping elastic sheet 21 and the second clamping elastic sheet 22 can be elastically deformed to clamp a position to be clamped on the mitral valve leaflet between the first clamping elastic sheet 21 and the second clamping elastic sheet 22. In this embodiment, the first clamping elastic piece 21 and the second clamping elastic piece 22 are made of shape memory material through a heat treatment process, and the memory metal is preferably nickel-titanium alloy, titanium-nickel-niobium alloy or titanium-nickel-palladium alloy.

Two side walls in the width direction (direction shown by L3 in fig. 1) of the second clamping elastic sheet 22 are provided with a plurality of obliquely arranged first inverted teeth 222, the second clamping elastic sheet 22 includes a middle portion and a first end and a second end located at two sides of the middle portion, each first inverted tooth 222 at the first end of the second clamping elastic sheet 22 gradually gets away from the second clamping elastic sheet 22 along a direction gradually approaching to the tail end of the first end, and the first inverted teeth 222 located at the same side at the first end and the second end are opposite in oblique direction. The rapid capture of the mitral valve leaflets is realized through the matching between the first clamping elastic sheet 21 and the second clamping elastic sheet 22, and meanwhile, the friction between the second clamping elastic sheet 22 and the mitral valve leaflets is increased by the first inverted teeth 222 on the second clamping elastic sheet 22, so that the clamping strength of the clamping assembly is ensured.

The locking assembly 3 is provided with a first through groove 311, the depth direction of the first through groove 311 is consistent with the first direction, and the first clamping elastic sheet 21 is located between the second clamping elastic sheet 22 and the bottom wall of the first through groove 311. In this embodiment, the locking assembly 3 includes a locking cap 31 having a first through slot 311, and an inner rod 32 having one end connected to the bottom wall of the first through slot 311. Preferably, the first through groove 311 is a U-shaped groove.

Since the actuating rod 4 needs to be detached after the leaflet repair holder is placed in the human body. For this purpose, one end of the actuating rod 4 passes through the main body frame 1, the second clamping spring piece 22 and the first clamping spring piece 21 in sequence and is detachably connected to the locking assembly 3. In this embodiment, the locking assembly 3 is threadedly coupled to the actuator rod 4. Specifically, interior pole 32 passes through modes such as laser welding, joint or tenon fourth of the twelve earthly branches and connects in the diapire of first logical groove 311, and the one end of being connected with the diapire of first logical groove 311 on interior pole 32 is equipped with the internal thread hole, and the one end of actuating lever 4 is equipped with the external screw thread with internal thread hole complex, and the cooperation through external screw thread and internal thread hole realizes actuating lever 4 and interior pole 32 can dismantle and be connected. In other embodiments, it is also possible to screw the actuating rod 4 directly into the locking cap 31, without the inner rod 32.

As shown in fig. 1 and fig. 6, in this embodiment, one end of the main body frame 1 is provided with a second through groove 11 extending along a second direction (L2 direction shown in fig. 1), an opening of the second through groove 11 is opposite to an opening of the first through groove 311, a bottom wall of the second through groove 11 is provided with a limiting column 12, the first clamping elastic sheet 21 and the second clamping elastic sheet 22 are sleeved on the limiting column 12, and two ends of the first clamping elastic sheet 21 and the second clamping elastic sheet 22 both extend out of the second through groove 11; in the two opposite side walls of the second through groove 11, each side wall is provided with a limit boss 13 pointing to the other side wall, and the minimum distance between the two limit bosses 13 is smaller than the minimum width of the first clamping elastic sheet 21 arranged in the second through groove 11. Through the arrangement, the middle parts of the first clamping elastic sheet 21 and the second clamping elastic sheet 22 are limited in the second through groove 11, so that the first clamping elastic sheet 21 and the second clamping elastic sheet 22 cannot be separated from the second through groove 11 along the first direction and the second direction.

As shown in fig. 6 and 7, in order to prevent the first clamping resilient piece 21 and the second clamping resilient piece 22 from rotating relative to the main body frame 1, the limiting post 12 is not limited to a spline-shaped structure, and both the first clamping resilient piece 21 and the second clamping resilient piece 22 are provided with spline holes 212 that are engaged with the limiting post 12.

In this embodiment, the actuating rod 4 can push the locking assembly 3 to move reciprocally relative to the main body frame 1 along the axial direction of the actuating rod 4 (the direction shown by L1 in fig. 1) to insert or remove the main body frame 1 into or from the first through slot 311, and at the same time, move the clamping assembly 2 to enable the first clamping elastic sheet 21 and the second clamping elastic sheet 22 to elastically deform to clamp the to-be-clamped position on the mitral valve leaflet. In this embodiment, the clamping assembly 2 can move between a closed state and an open state, as shown in fig. 1 to 3, the clamping assembly 2 is in the open state, and the first clamping elastic sheet 21 and the second clamping elastic sheet 22 are in a natural state and are attached to each other; pulling actuating lever 4 makes locking cap 31 move to the direction that is close to main part frame 1, as shown in fig. 4 and fig. 5, first clamp shell fragment 21 and second clamp shell fragment 22 take place elastic deformation and press from both sides the position of treating the clamp on the mitral valve leaflet and locate between first clamp shell fragment 21 and second clamp shell fragment 22, make clamping assembly 2 change from the open state to the closed state gradually, restrict first clamp shell fragment 21 outwards to expand through the relative both sides wall of first logical groove 311 simultaneously, play limiting displacement, guarantee the stability of clamping. It should be noted here that, in the present embodiment, by moving the actuating lever 4 toward the operator side, the "pull" is performed; conversely, by moving the actuating lever 4 away from the operator side, it is "pushed".

The gripper for repairing the valve leaflet provided by the embodiment drives the locking assembly 3 to reciprocate by pushing and pulling the actuating rod 4 so as to enable the main body frame 1 to be inserted into or separated from the first through groove 311, and simultaneously drives the clamping assembly 2 to move so as to enable the first clamping elastic sheet 21 and the second clamping elastic sheet 22 to elastically deform to clamp the position to be clamped on the valve leaflet, and two opposite side walls of the first through groove 311 limit the first clamping elastic sheet 21 to outwardly expand. Compared with the prior clamp holder, the clamp holder has simple operation in the whole process, and can realize the quick clamping of the valve leaflets, thereby shortening the operation time.

Further, as shown in fig. 1 and 7, two first drawing holes 211 are formed at both ends of the first clamping spring 21 in the length direction (the direction indicated by L2 in fig. 1), and a drawing wire (not shown) passes through the first drawing holes 211 to be connected to the locking cap 31. In this embodiment, two ends of the pulling wire are connected to the inner wall of the first through groove 311. Pushing the actuating rod 4 to drive the locking cap 31 to move so as to drive the pulling wire to move, and the pulling wire will drive the first clamping spring 21 to expand outwards; pulling the actuating rod 4 will drive the pull wire to move in the opposite direction, and the pull wire will drive the second clamping spring 22 to close inwards, and the opening and closing of the first clamping spring 21 are realized by pushing and pulling the actuating rod 4. When adjusting the opening and closing angle of the first clamping elastic sheet 21 through the actuating rod 4, the adjusting range of the opening and closing angle is 0-270 degrees, therefore, compared with the prior art, the clamping device for repairing the valve leaflet of the utility model has a larger opening and closing angle, thereby the valve leaflet can be clamped more easily.

In this embodiment, the opposite two side walls of the first through slot 311 are both provided with third through slots 312 extending along the second direction, and the openings of the third through slots 312 are opposite to the openings of the second through slots 11. Both ends of the traction wire penetrate into the second through-groove 11 from the corresponding third through-groove 312 to be connected to the inner wall of the first through-groove 311, respectively. The pulling wire and the inner wall of the first through slot 311 may be welded or connected by other methods, which are not limited herein.

Further, as shown in fig. 1, the leaflet repair holder of the present embodiment further includes a pulling wire (not shown) connected to the second pulling holes 221 at both ends in the length direction of the second clamping spring 22 through a delivery system. The size of the spread angle of the second clamping spring 22 is adjusted by adjusting the pulling steel wire so as to capture the mitral valve leaflets more quickly, and after the adjustment is completed, the pulling steel wire can be drawn out from the tail end of the conveying system so as to prevent the pulling steel wire from influencing the operation. The above described delivery systems are prior art and are not described herein in detail.

When the clamping assembly 2 is switched from the closed state to the open state, the actuating rod 4 is pushed to drive the locking cap 31 to move in a direction away from the main body frame 1 along the direction L1 in fig. 1 so as to drive the pull wire to move, the pull wire will drive the first clamping elastic sheet 21 to expand outwards, and the actuating rod 4 will drive the main body frame 1 to gradually separate from the first through groove 311.

When the clamping assembly 2 is switched from the open state to the closed state, the actuating rod 4 is pulled to drive the locking cap 31 to move in a direction close to the main body frame 1 along the direction L1 in fig. 1 so as to drive the pull wire to move, the pull wire will drive the first clamping elastic sheet 21 to close inwards, and simultaneously the actuating rod 4 will drive the main body frame 1 to gradually enter the first through groove 311.

In the embodiment, the push-pull actuating rod 4 is adopted to adjust the opening and closing of the first clamping elastic sheet 21, and the retracting and pulling steel wire is adopted to control the opening and closing of the second clamping elastic sheet 22, so that the rapid capturing of the valve leaflets and the clamping of the positions to be clamped on the valve leaflets of the mitral valve are realized, the operation steps are simple, the operation time can be reduced, and the operation risk can be reduced; and the first clamping elastic sheet 21 is restrained from expanding outwards by the two opposite side walls of the first through groove 311.

As shown in fig. 8 and 9, in order to enable the actuating rod 4 to move axially relative to the inner rod 32 when screwing the actuating rod 4, the main body frame 1 is provided with a through hole 14 for passing the inner rod 32, one of the outer wall of the inner rod 32 or the inner wall of the through hole 14 is provided with a sliding slot 15 extending axially along the inner rod 32, and the other is provided with a protrusion 322 engaged with the sliding slot 15. In this embodiment, the outer wall of the inner rod 32 is provided with a protrusion 322, the inner wall of the through hole 14 is provided with a sliding slot 15 matched with the protrusion 322, and the inner rod 32 can only move along the first direction through the matching of the protrusion 322 and the sliding slot 15.

Further, the leaflet repair holder provided by the present embodiment further includes a release rod 5, a free end of the inner rod 32 is inserted into an end of the release rod 5 in a radial direction of the inner rod 32, and an end of the actuation rod 4 passes through the release rod 5 and is screwed to the locking assembly 3 to fix the inner rod 32 and the release rod 5 relatively.

Specifically, as shown in fig. 9 and 10, one end of the disengagement lever 5 is provided with a projection 51, the free end of the inner lever 32 is provided with a groove 321 which is inserted into the projection 51, and the radial insertion of the disengagement lever 5 and the inner lever 32 is realized through the cooperation of the projection 51 and the groove 321. After one end of the actuating rod 4 passes through the disengagement rod 5 and is screwed to the inner rod 32, the actuating rod 4 can limit the radial movement and the axial movement between the disengagement rod 5 and the inner rod 32; after screwing the actuating rod 4 to disengage the actuating rod 4 from the inner rod 32, the disengaging rod 5 can be moved radially to disengage from the inner rod 32. In the present embodiment, the protrusion 51 is formed by providing an S-shaped notch at one end of the release lever 5, but the protrusion 51 is not limited to the above configuration, and may be a rectangular protrusion or other shapes.

In other embodiments of the present invention, the positions of the protrusion 51 and the groove 321 can be interchanged, i.e. the protrusion 51 is disposed on the inner rod 32, and the groove 321 is disposed on the separation rod 5.

Further, as shown in fig. 9, the free end of the inner rod 32 is provided with a second inverted tooth 323, and in the process of capturing the to-be-clamped position on the mitral valve leaflet through the first clamping elastic sheet 21 and the second clamping elastic sheet 22, the second inverted tooth 323 is clamped between the inner rod 32 and the main body frame 1; after the first clamping elastic sheet 21 and the second clamping elastic sheet 22 capture the to-be-clamped position on the mitral valve leaflet, the actuating rod 4 is pulled until the second clamping elastic sheet 22 is completely closed, the to-be-clamped position on the mitral valve leaflet is clamped between the first clamping elastic sheet 21 and the second clamping elastic sheet 22, the second inverted tooth 323 on the inner rod 32 is popped out from the inside of the main body frame 1, the second inverted tooth 323 is clamped at one end of the main body frame 1 departing from the second through groove 11, the movement of the inner rod 32 is limited, so that the relative position between the locking assembly 3 and the main body frame 1 is fixed, the outer side of the first clamping elastic sheet 22 abuts against the inner wall of the first through groove 311, and the mitral valve leaflet clamped between the first clamping elastic sheet 21 and the second clamping elastic sheet 22 is ensured not to fall out.

The body frame 1, the clamping assembly 2, the locking assembly 3, the actuating rod 4 and the employed connecting pieces in this embodiment are all made of biocompatible materials. The biocompatible material may be selected from nickel titanium alloy, cobalt chromium alloy, stainless steel, polymer, silicone, etc. The first and second

inverted teeth

222, 323 in this embodiment are atraumatic inverted teeth, i.e., do not cause trauma to the mitral valve leaflet tissue when capturing the mitral valve leaflets.

Further, the surface of the first clamping spring 21 and/or the second clamping spring 22 is provided with an anti-slip layer in order to further enhance the clamping action on the valve leaflets. The anti-slip layer may be a frosted layer, or protrusions may be provided on the surfaces of the first clamping elastic sheet 21 and the second clamping elastic sheet 22, and the shape of the protrusions may be wave shape, convex point shape, etc., which is not limited herein. Preferably, the anti-slip layer is disposed on a side of the first clamping spring plate 21 facing the second clamping spring plate 22, and the second clamping spring plate 22 facing the first clamping spring plate 21.

The leaflet repair holder of the present embodiment can be mounted in a delivery system for interventional procedures on the heart. The following describes the specific operation of the holder for repairing the valve leaflet by taking the "edge-to-edge" closed repair of the mitral valve as an example.

The clamping assembly 2 is in a fully closed state prior to entering the left atrium of the leaflet repair holder and is placed in a delivery system to ensure the fluency of its intervention via the femoral vein access, preventing excessive bulk from affecting other tissues of the mitral valve. After transseptal puncture, the position of the clamp holder for leaflet repair is adjusted by the delivery system from the right atrium to the left atrium under the guidance of the contrast equipment through an operating handle in the delivery system, after the target position is reached, the first clamping elastic sheet 21 is opened by pushing the actuating rod 4, meanwhile, the second clamping elastic sheet 22 is unfolded according to the shape memory function of the first clamping elastic sheet, and the unfolding angle of the second clamping elastic sheet 22 is adjusted by pulling a steel wire, so that the edge of the mitral valve can be captured more quickly. When the first clamping elastic sheet 21 contacts the mitral valve, the traction steel wire controlling the second clamping elastic sheet 22 is released, the second clamping elastic sheet 22 and the first clamping elastic sheet 21 are matched to clamp the edge of the mitral valve, and then the traction steel wire is drawn out. By adjusting the actuating rod 4 so that the outer clamping arms are gradually closed, the clamping of the edge of the mitral valve is achieved by the second clamping spring piece 22 and the first clamping spring piece 21. After confirmation of the completion of the procedure that mitral regurgitation has been relieved, the entire delivery system, actuating rod 4 and release rod 5 are withdrawn and the remainder of the leaflet repair holder remains at the edge of the mitral valve.

It is obvious that the above embodiments of the present invention are only examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. Wherein the terms "first position" and "second position" are two different positions.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Claims

1. A leaflet repair holder, comprising:

the clamping device comprises a main body frame (1) and a clamping assembly (2), wherein the clamping assembly (2) comprises a first clamping elastic sheet (21) and a second clamping elastic sheet (22) located on one side of the first clamping elastic sheet; the first clamping elastic sheet (21) and the second clamping elastic sheet (22) penetrate through the main body frame (1) and two ends of the first clamping elastic sheet and the second clamping elastic sheet extend out of the main body frame (1);

the locking assembly (3) is provided with a first through groove (311);

the actuating rod (4) penetrates through the main body frame (1), the second clamping elastic sheet (22) and the first clamping elastic sheet (21) in sequence and is detachably connected to the locking assembly (3), the actuating rod (4) can reciprocate relative to the main body frame (1) along the axial direction of the actuating rod to enable the main body frame (1) to be inserted into or separated from the first through groove (311), and meanwhile the first clamping elastic sheet (21) and the second clamping elastic sheet (22) can elastically deform to clamp positions to be clamped on valve leaflets.

2. The leaflet repair holder of claim 1, wherein the locking assembly (3) is threadedly connected with the actuating rod (4).

3. The leaflet repair holder according to claim 2, wherein the locking assembly (3) comprises a locking cap (31) provided with the first through groove (311), and an inner rod (32) connected with the locking cap (31), wherein one end of the inner rod (32) connected with the locking cap (31) is provided with an internal threaded hole, one end of the actuating rod (4) is provided with an external thread matched with the internal threaded hole, and the detachable connection of the actuating rod (4) and the inner rod (32) is realized through the matching of the external thread and the internal threaded hole.

4. The clamper for repairing the valve leaflet of claim 3, wherein one end of the main body frame (1) is provided with a second through groove (11), the first through groove (311) is opposite to the opening of the second through groove (11), the bottom wall of the second through groove (11) is provided with a limiting column (12), the first clamping elastic sheet (21) and the second clamping elastic sheet (22) are sleeved on the limiting column (12), and two ends of the first clamping elastic sheet (21) and the second clamping elastic sheet (22) extend out of the second through groove (11).

5. The leaflet repair holder of claim 4, wherein of the two opposite side walls of the second through slot (11), each of the side walls is provided with a limit boss (13) pointing to the other side wall, and the minimum distance between the two limit bosses (13) is smaller than the minimum width of the first clamping spring (21) placed in the second through slot (11).

6. The leaflet repair holder of claim 4, wherein the free end of the inner rod (32) is provided with a second barb (323);

the free end of the inner rod (32) penetrates through the main body frame (1) and can enable the second inverted tooth (323) to abut against one end, away from the second through groove (11), of the main body frame (1), or the second inverted tooth (323) is clamped between the inner rod (32) and the main body frame (1).

7. The leaflet repair holder of claim 3, further comprising:

the free end of the inner rod (32) is connected with one end of the disengagement rod (5) in an inserting mode along the radial direction of the inner rod (32), and one end of the actuating rod (4) penetrates through the disengagement rod (5) and is in threaded connection with the locking assembly (3) so that the inner rod (32) and the disengagement rod (5) are fixed relatively.

8. The holder for leaflet repair according to claim 3, wherein the main frame (1) is provided with a through hole (14) for passing the inner rod (32), one of the outer wall of the inner rod (32) or the inner wall of the through hole (14) is provided with a sliding groove (15) extending axially along the inner rod (32), and the other is provided with a protrusion (322) engaged with the sliding groove (15).

9. The leaflet repair holder of any one of claims 1 to 8, further comprising:

the two ends of the first clamping elastic sheet (21) in the length direction are respectively provided with a first traction hole (211), and the traction wire penetrates through the first traction holes (211) and is connected to the locking assembly (3);

the two ends of the second clamping elastic sheet (22) in the length direction are provided with second traction holes (221), and the traction steel wire is connected to the second traction holes (221) through a conveying system.

10. The leaflet repair holder according to any one of claims 1 to 8, characterized in that the surface of the first clamping spring (21) and/or the second clamping spring (22) is provided with an anti-slip layer.