CN216570346U

CN216570346U - Valve repair device and valve repair system

Info

Publication number: CN216570346U
Application number: CN202122979174.5U
Authority: CN
Inventors: 谭健
Original assignee: Zhixin Medical Technology Shanghai Co ltd
Current assignee: Zhixin Medical Technology Shanghai Co ltd
Priority date: 2021-11-30
Filing date: 2021-11-30
Publication date: 2022-05-24
Anticipated expiration: 2031-11-30

Abstract

The utility model provides a valve repair device and a valve repair system, wherein the lifting component is of a rigid structure, the near end of the lifting component is rotatably connected to the far end of the stop structure, the far end of the lifting component is rotatably connected to the far end of the driving rod and is used for changing the shape of the lifting component through the axial movement of the driving rod, so that the lifting component can realize valve lift, valve clamping and chordae tendineae release under 0-360 degrees, the product specification number is reduced, the flexibility and convenience of operation of a doctor are greatly increased, and meanwhile, if the valve repair device hooks chordae tendineae in the operation process, the structure is flexible, so that a larger included angle and a smaller diameter can be realized under the opening state, and the valve repair device is easier to release.

Description

Valve repair device and valve repair system

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a heart valve repair device and a heart valve repair system, which realize valve repair by adopting a minimally invasive intervention mode.

Background

Heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) play a critical role in ensuring forward flow of adequate blood supply through the cardiovascular system. These heart valves may be compromised by congenital malformations, inflammatory processes, infectious conditions, disease, etc., resulting in a reduced effectiveness of the heart valve, which damage can lead to serious cardiovascular damage or death. Damaged heart valves may be repaired or replaced by open heart surgery. However, open heart surgery is highly invasive, which may cause complications. Transcatheter interventional vascular techniques may introduce and implant prosthetic devices in a much less invasive manner than direct visualization of the heart for surgery. The valve repair device is mainly applied to a transcatheter interventional vascular technology, realizes valve edge-to-edge repair through a transcatheter, and has small wound and quick recovery compared with the traditional operation.

The current edge-to-edge intervention repair device has a complex structure or has functional defects. Such as the Mitraclip product. The two jaws of the Mitraclip product are integrally connected and are a single piece, so that the jaws clamp the valve leaflets with limited angle between the two jaws, which can easily result in poor clamping when facing different patient groups and can easily cause the implant to tangle or jam with the relevant tissue (e.g., chordae tendineae) when positioning or retrieving the implant. For example, a Pascal product adopts a flexible lifting structure as a lifting mechanism, so that the conveying length of the repair device is long, the repair device is not beneficial to blood vessel conveying, the locking structure is not high in reliability through elasticity locking, the clamping area of the valve leaflet is too large, and the like.

SUMMERY OF THE UTILITY MODEL

The utility model aims to provide a valve repair device and a valve repair system, which have good valve leaflet clamping effect, improve the use convenience of products, reduce the number of product specifications, expand product indications and reduce the operation difficulty.

In order to solve the above problems, the present invention provides a valve repair device, which includes a stopping structure, a driving rod and a clamping and lifting structure, wherein the driving rod is axially movably inserted into the stopping structure, and the proximal end of the driving rod is detachably connected to the distal end of a delivery catheter, and the stopping structure is located at the proximal end of the driving rod and is used for switching the axial movement state and the locking state of the driving rod;

the clamping and lifting structure comprises a clamping component and a lifting component, the lifting component is of a rigid structure, the clamping component is arranged at the near end of the lifting component and is used for being matched with the lifting component to clamp the valve leaflet, the near end of the lifting component is rotatably connected to the far end of the stopping structure, the far end of the lifting component is rotatably connected to the far end of the driving rod and is used for enabling the shape of the lifting component to be changed through the axial movement of the driving rod, and therefore the lifting component can realize valve leaflet lifting, valve leaflet clamping and tendon releasing under the condition of 0-360 degrees.

Optionally, the clamping part includes two clamping jaws, lift the part and include two head rods and two second connecting rods, every the one end and one of head rod behind the one end rotatable coupling of second connecting rod, every the other end of head rod with the distal end rotatable coupling of retaining structure, every the other end of second connecting rod with the distal end rotatable coupling of actuating lever, every the clamping jaw sets up one respectively on the head rod, the clamping jaw with the head rod cooperation is used for centre gripping leaflet, it passes through to lift the part the axial motion of actuating lever changes the shape that head rod and second connecting rod are constituteed changes.

Furthermore, the included angle between the two first connecting rods ranges from 0 degree to 360 degrees.

Furthermore, when the included angle between the two first connecting rods is 0-20 degrees, the clamping and lifting structure is used for folding the valve leaflets;

when the included angle between the two first connecting rods is 90-180 degrees, the lifting component is used for capturing valve leaflets; and

when the included angle between the two first connecting rods is 270-360 degrees, the lifting component is used for releasing the wound chordae tendineae.

Furthermore, when the included angle of the two first connecting rods is 0-360 degrees, the clamping component clamps the valve leaflets.

Furthermore, when the included angle between the two first connecting rods is 90-180 degrees, the clamping component clamps the valve leaves.

Furthermore, the two first connecting rods and the two second connecting rods are respectively symmetrically arranged on two sides of the driving rod.

Furthermore, two the first connecting rod, two the clamping jaw and two the second connecting rod is equallyd divide respectively the symmetry and sets up the both sides at the actuating lever.

Furthermore, the first connecting rod and the second connecting rod are made of rigid materials, and the clamping jaw is made of elastic materials or super-elastic materials.

Further, the clamping jaw includes fixed part and movable portion, fixed part and movable portion are connected to have the negative contained angle, movable portion can wind the fixed part rotates, and rotates movable portion makes contained angle is greater than or equal to 0 between fixed part and the movable portion when, produce the resilience force between fixed part and the movable portion, and the resilience force increases along with the increase of contained angle.

Further, the one end of fixed part with the one end of mobile portion is connected and is formed the link, the fixed part have with the relative first free end that sets up of link, mobile portion have with the relative second free end that sets up of link, the fixed part is fixed on the head rod, just the link is close to the actuating lever sets up, mobile portion laminating sets up the head rod is close to on one side of near-end, just contained angle is 0 between fixed part and the mobile portion, rebound force has between mobile portion and the fixed part.

Furthermore, the second free end is provided with a through hole, the through hole is used for being connected with the far end of the pull wire, when the near end of the pull wire provides pulling force, the second free end is far away from the first free end along with the pulling force and rotates, and along with the rotation of the movable part, the resilience force between the movable part and the fixed part is increased.

In another aspect, the utility model provides a valve repair system, which includes the valve repair device, and a delivery device, the delivery device includes a delivery catheter, a distal end of the delivery catheter is detachably connected to a proximal end of the driving rod, the delivery catheter and the driving rod are axially movably inserted into the stopping structure, and when the delivery catheter drives the driving rod to axially move, the shape of the lifting component changes, so as to release chordae tendinae, lift leaflets, clamp and close the leaflets.

In yet another aspect, the present invention provides a method of operating a valve repair system, comprising the steps of:

the driving rod moves axially, so that when the included angle theta between the two first connecting rods is 0-20 degrees, the valve repairing device is delivered;

the driving rod moves axially, so that when the included angle theta between the two first connecting rods is 270-360 degrees, the lifting part is released from the wound chordae tendineae;

the driving rod moves axially, pulling force is simultaneously applied to the two clamping jaws, the second free end is close to the driving rod, when the included angle theta between the two first connecting rods is 90-180 degrees, the valve leaflets are captured by the lifting part, and the pulling force of the two clamping jaws is withdrawn, so that the two clamping jaws and one first connecting rod respectively clamp the valve leaflets simultaneously; and

the driving rod moves axially, so that when the included angle theta between the two first connecting rods is 0-20 degrees, the valve blades are folded to realize the edge-to-edge technology.

Compared with the prior art, the utility model has the following technical effects:

the utility model provides a valve repair device and a valve repair system, wherein the lifting part is a rigid structure, the near end of the lifting part is rotatably connected to the far end of the stop structure, the far end of the lifting part is rotatably connected to the far end of the driving rod and used for changing the shape of the lifting part through the axial movement of the driving rod, so that the lifting part can lift valve leaflets, clamp the valve leaflets and release chordae tendineae under the angle of 0-360 degrees, the flexibility and the convenience of the operation of a doctor are greatly improved, and meanwhile, in the operation process, if the valve repair device hooks the chordae tendineae, the structure is flexible, so that a larger included angle and a smaller diameter can be realized in an open state, and the valve repair device is easier to release.

Furthermore, through second free end has the through-hole, the through-hole is used for connecting the distal end of acting as go-between, when the near-end of acting as go-between provided the pulling force, the second free end is kept away from along with the pulling force first free end, and rotates, along with the rotation of movable portion, the resilience force increase between movable portion and the fixed part has further increased flexibility and the convenience of doctor's operation.

Furthermore, the two first connecting rods and the two second connecting rods are symmetrically arranged on two sides of the driving rod respectively, so that the whole structure is designed in a completely symmetrical mode, the types of related parts are fewer, the technical process is less, and batch production is facilitated.

Drawings

FIG. 1a is a schematic view of a valve repair system according to an embodiment of the present invention;

FIG. 1b is an enlarged view of area A of FIG. 1;

FIGS. 2a-2b are schematic views of a valve repair device according to an embodiment of the present invention;

FIG. 3 is a schematic structural diagram of a first connecting rod according to an embodiment of the present invention;

FIG. 4 is a schematic structural diagram of a second connecting rod according to an embodiment of the present invention;

FIG. 5 is a schematic view of a jaw configuration according to an embodiment of the present invention;

fig. 6a-6c are schematic structural views of a lift member in different states according to an embodiment of the present invention.

Description of reference numerals:

1-a valve repair device; 2-a catheter assembly; 21-a delivery catheter; 22-an inner sheath catheter; 23-a sheath catheter; 3-a delivery handle; 31-a first handle; 32-a second handle; 33-a third handle; 4-a leaflet;

100-a drive rod;

200-a stop structure; 210-driving the slider; 211 — a first sidewall; 212-a second side wall; 220-a retaining member;

300-a jaw member; 310-a clamping jaw; 310 a-a connection end; 311-a fixed part; 311 a-first free end; 312 — a movable part; 312 b-a second free end; 313-a second opening; 314-an opening; 315-a via; 316-barbs;

400-a lift member; 410-a first connecting rod; 410 a-a first end; 410 b-a second end; 411-a first bottom wall; 412-a first connecting wall; 413-a first gap; 414-first opening; 415-a first hinge hole; 420-a second connecting rod; 420 a-first end; 420 b-a second end; 421-a second bottom wall; 422-a second connecting wall; 423-a second notch; 424-third gap; 425-a first suture hole; 426-a second hinge hole; 427-a notch; 428-second suture hole.

Detailed Description

The core idea of the utility model is to provide a valve repair device, which comprises a stopping structure, a driving rod and a clamping and lifting structure, wherein the driving rod is axially movably arranged in the stopping structure in a penetrating way, the near end of the driving rod is detachably connected with the far end of a conveying catheter, and the stopping structure is positioned at the near end of the driving rod and is used for switching the axial movement state and the locking state of the driving rod;

In another aspect, the utility model further provides a valve repair system, which includes the valve repair device, and a delivery device, where the delivery device includes a delivery catheter, a distal end of the delivery catheter is detachably connected to a proximal end of the driving rod, the delivery catheter and the driving rod are axially movably inserted into the stopping structure, and when the delivery catheter drives the driving rod to axially move, the shape of the lifting component changes, so as to release chordae tendineae, lift leaflets, clamp and close the leaflets.

In yet another aspect, the present invention also provides a method of operating a valve repair system, comprising the steps of:

the driving rod moves axially, pulling force is simultaneously applied to the two clamping jaws, the second free end is close to the driving rod, when the included angle theta between the two first connecting rods is 90-180 degrees, the valve blades are captured by the lifting component, and the pulling force of the two clamping jaws is withdrawn, so that the two clamping jaws and one first connecting rod clamp the valve blades simultaneously; and

A valve repair device, valve repair system, and method of operation thereof, according to the present invention, are described in further detail below. The present invention will now be described in more detail with reference to the accompanying drawings, in which preferred embodiments of the utility model are shown, it being understood that one skilled in the art may modify the utility model herein described while still achieving the advantageous effects of the utility model. Accordingly, the following description should be construed as broadly as possible to those skilled in the art and not as limiting the utility model.

In the interest of clarity, not all features of an actual implementation are described. In the following description, well-known functions or constructions are not described in detail since they would obscure the utility model in unnecessary detail. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific details must be set forth in order to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art.

In order to make the objects and features of the present invention more comprehensible, embodiments of the present invention are described in detail below with reference to the accompanying drawings. It is to be noted that the drawings are in a very simplified form and are each provided with a non-precise ratio for the purpose of facilitating and clearly facilitating the description of the embodiments of the present invention. As used herein, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The terms "inner", "outer", and the like as used herein are for illustrative purposes only and do not denote a unique embodiment. Herein, the terms "distal" and "proximal" are all relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a physician using the medical device, although "distal" and "proximal" are not intended to be limiting, but "proximal" generally refers to the end of the medical device that is closer to the operator during normal operation, and "distal" generally refers to the end that is closer to the patient's heart.

Fig. 1a is a schematic structural diagram of a valve repair system provided in this embodiment. FIG. 1b is an enlarged view of area A in FIG. 1. 1a-1b, the present embodiment provides a valve repair system comprising a delivery device and a valve repair device removably attached to a distal end of the delivery device.

The delivery device comprises a delivery handle 3 and a catheter assembly 2, wherein the catheter assembly 2 comprises an outer sheath catheter 23, an inner sheath catheter 22 and a delivery catheter 21 which are sequentially sleeved from outside to inside, the distal end of the inner sheath catheter 22 extends out of the distal end of the outer sheath catheter 23, and the distal end of the delivery catheter 21 extends out of the distal end of the inner sheath catheter 22.

The delivery handle 3 comprises a first handle 31, a second handle 32 and a third handle 33 which are sequentially arranged from the proximal end to the distal end, wherein the first handle 31 is connected with the proximal end of the delivery catheter 21 and is used for controlling the valve repair device 1 to realize the functions of loading, delivering, releasing and the like during delivery; the second handle 32 is connected with the proximal end of the inner sheath catheter 22 and is used for controlling the bending control of the distal end of the inner sheath catheter 22 so as to establish a minimally invasive access channel during the delivery process; the third handle 33 is attached to the proximal end of the outer sheath catheter 23 and is used to control bending of the outer sheath catheter 23 to create a minimally invasive access path to the inner sheath catheter 22, delivery catheter 21, and valve repair device 1 during delivery.

Fig. 2a-2b are schematic structural views of the valve repair device of the present embodiment. As shown in fig. 2a-2b, the valve repair device 1 includes a driving rod 100, a stopping structure 200, and a clamping and lifting structure, wherein the driving rod 100 is axially movably inserted into the stopping structure 200, the stopping structure 200 is located at a proximal end of the driving rod 100, the clamping and lifting structure is rotatably connected to a distal end of the driving rod 100 and further rotatably connected to the stopping structure 200, so that when the driving rod 100 axially moves in the stopping structure 200, the clamping and lifting structure rotates at a connection point with the stopping structure 200 and a connection point with the driving rod 100, thereby driving the shape of the clamping and lifting structure to change, so as to realize the lifting and clamping of the valve leaflet.

Stop structure 200 includes drive slider 210 and sets up retaining member 220 in the drive slider 210, drive lever 100 wears to establish in drive slider 210 and retaining member 220, makes in transportation process, conveying pipe 21 drives drive lever 100 is in carry out axial motion in the drive slider 210, retaining member 220 switches the axial motion state and the locking state of drive lever 100 to switch the release state and the locking state of centre gripping lifting structure.

The driving slider 210 includes a proximal portion and a distal portion in sequence from the proximal end to the distal end along the axial direction, the proximal portion is substantially tubular, the distal portion includes a first sidewall 211 and a second sidewall 212 which are oppositely disposed, the proximal end of the first sidewall 211 and the proximal end of the second sidewall 212 are both connected to the distal end of the proximal portion, and preferably, the first sidewall 211 and the second sidewall 212 are disposed in parallel.

The centre gripping lifting structure is used for lifting and centre gripping leaflet, the centre gripping lifting structure includes lifting component 400 and clamping jaw part 300, clamping jaw part 300 sets up lifting component 400 is last, lifting component 400 rotatable connection be in drive slider 210's distal end portion is used for lifting the leaflet, and is detailed, lifting component 400 rotatable connection is on first lateral wall 211 and second lateral wall 212, clamping jaw part 300 is used for cooperating the centre gripping leaflet with lifting component 400.

The lifting member 400 includes two first connection rods 410 and two second connection rods 420, the two first connection rods 410 each include a first end 410a and a second end 410b, the two second connection rods 420 each include a first end 420a and a second end 420b, the second end 410b of each of the first connection rods 410 is rotatably connected to one of the second ends 420b of the second connection rods 420, the first ends 410a of the two first connection rods 410 are rotatably connected to both the first sidewall 211 and the second sidewall 212 of the distal end portion, and one of the first connection rods 410 and the second connection rod 420 connected to each other and the other of the first connection rods 410 and the second connection rod 420 connected to each other are symmetrically disposed at both sides of the driving lever 100. In detail, the distal end of actuating lever 100 is fixed with connecting portion, connecting portion fix the distal end tip of actuating lever 100, connecting portion have two ears, every in the radial both sides of actuating lever 100 the equal symmetrical rotatable connection of first end 420a of second connecting rod 420 is in one on the ear, above-mentioned structure makes lifting part 400 adopt the symmetry design for the spare part kind that it relates to is few, and the process is changed fewly, is favorable to mass production. The bracket structure changes a quadrangle formed by the first connecting rod 410 and the second connecting rod 420 which are sequentially connected through the change of the axial length of the driving rod 100 between the connecting piece and the driving slider 210 (i.e. the conveying conduit drives the driving rod 100 to axially slide in the driving slider 210), so as to promote the first connecting rod 410 and the second connecting rod 420 to move, and finally realize that the first connecting rod 410 and the second connecting rod 420 are in different postures (i.e. the lifting posture, the clamping posture and the like of the valve leaflets). Further, the second end 410b and the second end 420b, the first end 410a and the driving slider 210, and the first end 420a and the connecting member are hinged by hinges of the connecting shafts to realize the connection between the two first connecting rods 410, between the two second connecting rods 420, and between the first connecting rods 410 and the second connecting rods 420, so that the included angle θ between the two first connecting rods 410 is 0-360 °, typically, when the included angle θ is 0-20 °, the clamping and lifting structure is closed, that is, the clamping and lifting structure closes the valve leaflet; when the included angle is 0-360 degrees, the clamping component clamps the valve leaflets, and preferably, when the included angle theta is 90-180 degrees, the lifting component captures the valve leaflets in the most appropriate state; when the included angle theta is 270 degrees to 360 degrees, the lifting component is beneficial to releasing after the chordae tendineae are wound. The connecting shaft can be hinged with other parts through riveting, welding and the like.

The axial length of the first connecting rod 410 is less than that of the second connecting rod 420, and the two groups of first connecting rods 410 and second connecting rods which are adjacently arranged are symmetrically arranged along the driving rod 100, so that the lifting component 400 has a symmetrical design, the lifting component 400 realizes the function of lifting the valve leaflet of the valve repair device through the axis of the driving rod 100, and the function of folding the valve leaflet is achieved after the valve leaflet is clamped.

Fig. 3 is a schematic structural diagram of the first connecting rod of the present embodiment. As shown in fig. 3, the first connecting rod 410 is a U-shaped strip structure, and includes a first bottom wall 411 and two first connecting walls 412 connected to two sides of the first bottom wall 411, where the two first connecting walls 412 are disposed on the same side and opposite to each other, and both are located in the direction of the first bottom wall 411. Each of the first connection walls 412 is provided with a first hinge hole 415 on each of the first and

second ends

410a and 410b of the first connection bar 410, and the first hinge holes 415 are used to mount connection shafts to form hinges so as to hinge the first connection bar 410 and the driving slider 210 or the first and second connection bars 410 and 420. The first bottom wall 411 has a first notch 413 at the first end 410a of the first connecting rod 410, the first notch 413 is, for example, a rectangular notch, and is used for preventing the interference between the first connecting rod 410 and the driving slider 210 when the first bottom wall 411 rotates, and a plurality of first holes 414 are further formed in the first bottom wall 411, and the first holes 414 are used for sewing or bonding the jaw members 300.

Fig. 4 is a schematic structural diagram of the second connecting rod of the present embodiment. As shown in fig. 4, the second connecting rod 420 is a U-shaped strip structure, and includes a second bottom wall 421 and two second connecting walls 422 connected to two sides of the second bottom wall 421, where the two second connecting walls 422 are disposed at the same side and opposite to each other, and both are located in the longitudinal direction of the second connecting walls 422. Each of the second connection walls 422 is provided with second hinge through holes on the first end 420a and the second end 420b of the second connection rod 420 for installing connection shafts to form hinges to hinge the second connection rod 420 and the driving lever 100 or the second connection rod 420 and the first connection rod 410, and the first hinge holes 415 and the second hinge holes 426 for hinging the second connection rod 420 and the first connection rod 410 are oppositely disposed. The second bottom wall 421 has a second notch 423 at the first end 420a of the second connecting rod 420 and a third notch 424 at the second end 420b, and the second notch 423 and the third notch 424 are rectangular notches, for example, and the second notch 423 and the third notch 424 are used for avoiding interference between the second connecting rod 420 and the driving rod 100 during rotation. The second bottom wall 421 is further provided with a plurality of first stitching holes 425, a second stitching hole 428 is arranged between the second hinge through holes at the two ends of the second connecting wall 422, and the first stitching holes 425 and the second stitching holes 428 are used for stitching or bonding the surface coating material. The second connecting wall 422 has a notch 427 near the first end 420a, and the notch 427 is used to prevent interference between the first connecting rod 410 and the second connecting rod 420 when rotating. In addition, to avoid interference, the first connecting rod 410 and the second connecting rod 420 are both formed into rigid parts by stamping, die casting, bending, or the like. The longitudinal direction is the left-right direction in fig. 3 and 4.

Fig. 5 is a schematic structural view of the clamping jaw of the embodiment. As shown in fig. 5, referring to fig. 2a-2b, in the present embodiment, the jaw member 300 includes two jaws 310, each jaw 310 is fixed on a first connecting rod 410, and the two jaws 310 are symmetrically disposed on two sides of the driving rod 100, and further, the jaws 310 are symmetrically fixed on a first bottom wall 411 of the first connecting rod 410. The clamping jaw 310 is formed by cutting and processing a metal sheet, and specifically, the clamping jaw 310 may be formed by processing a material having elasticity or super elasticity, such as stainless steel, nickel titanium alloy, and the like.

Referring to fig. 5, in the present embodiment, the clamping jaw 310 includes a fixed portion 311 and a movable portion 312, a connecting end 310a is disposed between the fixed portion 311 and the movable portion 312 to connect the fixed portion 311 and the movable portion 312, and the connecting end 310a is formed by connecting one end of the fixed portion 311 and one end of the movable portion 312, specifically by welding, sewing, bonding, and integrally cutting. The fixing portion 311 is in an elongated shape, and has a first free end 311a opposite to the connecting end 310a, the movable portion 312 is also in an elongated shape, and has a second free end 312b opposite to the connecting end 310a, the movable portion 312 can rotate around the fixing portion 311 with the connecting end 310a as a center, and defines that the connecting end 310a as a center as shown in fig. 5, the connecting end 310a is at a position of 0 ° as a starting point in a direction of the first free end 311a, and the first free end 311a is at a positive angular rotation direction in a counterclockwise direction a as a starting point, and the first free end 311a is at a negative angular direction in a clockwise direction as a starting point, at this time, the position of the movable portion 312 is at a negative angular position, that is, an included angle between the movable portion 312 and the fixing portion 311 is a negative value, and the movable portion 312 can rotate around the connecting end 310a in a counterclockwise direction, the rotation angle is-180-270 degrees, preferably-45-180 degrees. The movable portion 312 has an opening 314, the opening 314 is disposed along the length direction of the movable portion 312, when the movable portion 312 rotates until the fixed portion 311 and the movable portion 312 overlap, the fixed portion 311 is located in the opening 314, and the opening 314 enables the movable portion 312 to pass through the overlapping position of the fixed portion 311 from the outside during rotation.

When the fixed portion 311 is fixed on the first connecting rod 410, the movable portion 312 is rotated clockwise, so that the included angle between the fixed part 311 and the movable part 312 is greater than or equal to 0, then, the fixing portion 311 is fixed to the first connecting rod 410 by welding, sewing, or bonding, and at this time, due to the rotation of the movable portion 312, the elastic deformation resilience force is provided between the movable portions 312, so that the movable portion 312 is attached to the first bottom wall 411, and the connection end 310a is adjacent to the first end 410a of the first connection rod 410, the first free end 311a and the second free end 312b are both disposed near the second end 410b of the first connecting rod 410, and the movable part 312 and the first bottom wall 411 have a pressing force therebetween, so as to provide a strong clamping force when the clamping jaw 310 subsequently clamps the valve leaflet.

The fixing portion 311 is formed with a plurality of second openings 313, and the second openings 313 and the first openings 414 are overlapped and used for fixing the fixing portion 311 to the first connecting rod 410. The second opening 313 may have a regular shape such as a circle, a semicircle, a square, etc.

The movable portion 312 includes a through hole AT the second free end 312b, and the through hole is used for providing a pull line to provide a rotatable pulling force to the movable portion 312 (providing a pulling force of the movable portion along the counterclockwise rotation direction AT in fig. 5), so that the movable portion 312 in the overlapped movable portion 312 and the fixed portion 311 is deformed relative to the fixed portion 311, and an included angle between the fixed portion 311 and the movable portion 312 is changed. Two ends of the movable part 312 perpendicular to the long direction are provided with a plurality of barbs 316 which are uniformly distributed, so as to realize better clamping of the valve leaflets. Each jaw 310 has a separate pull wire so that both jaws 310 can grip the leaflets simultaneously or separately.

The valve repair device further comprises a cover which covers the outer side of the lifting part and is sewn or adhesively fixed by the first and second sewing holes 425 and 428. The main material of the covering may be a woven fabric of PET or PTFE. Because the clamping and lifting components are of a symmetrical structure, the valve repair device coated with the covering also has a symmetrical structure. The number of parts of the whole structure is small, the technological process is few, and the mass production is facilitated.

During operation, the delivery catheter drives the drive rod 100 to slide within the drive slide 210 of the stop mechanism 200 to change the shape of the lift element by changing the axial length of the drive rod 100 between the connector and the drive slide 210. Firstly, when the driving rod moves axially to enable the included angle theta between the two first connecting rods to be 0-20 degrees, the valve repairing device is delivered. After delivery to the target site, there are more chordae tendineae under the mitral valve leaflets, based on actual anatomy, primarily concentrated on the underside of A1P1 and A3P 3. When lifting the valve leaflet, the first connecting rod 410 is likely to be entangled with the native chordae tendineae, at which time it may be necessary to withdraw the valve repair device from below the valve leaflet (left ventricle) to above the valve leaflet (left atrium), and therefore, it is necessary to make the axial length of the driving rod 100 between the connecting member and the driving slider 210 larger and gradually closer to the length of the first connecting rod 410 and the second connecting rod 420, and when the included angle θ between the two first connecting rods 410 is 270 ° to 360 °, the lifting member can be detached from the entangled chordae tendineae (as shown in fig. 6 a), at which time each of the clamping jaws 310 can be attached to the first connecting rod 410 to which it is fixed, and the second free end 312b can be disposed close to the proximal end of the driving rod 100 by pulling the wire, and the outer dimension d of the lifting member in the radial direction of the driving rod 100 becomes smaller as the included angle θ between the two first connecting rods 410 approaches 360 °, so that the lifting part can be easily withdrawn from the chordae tendineae; when the lifting means are required to lift the leaflets, after being released from the chordae tendineae, each of the jaws 310 is pulled so that the second free end 312b is disposed near the proximal end of the drive rod 100, and gradually reduces the axial length of the driving rod 100 between the connecting member and the driving slider 210, to catch the leaflets, wherein when the included angle of the two first connecting rods is 0-360 degrees, the clamping component clamps the valve blades, the most suitable state for catching the leaflets (i.e., the state in which the clamping member more easily clamps the leaflets) is that the included angle theta between the two first connecting rods 410 is 90-180 degrees, this angle prevents the leaflets from slipping off during closure, and withdraws the pulling force provided by the pull wire, so that the movable portion 312 rebounds and clamps the valve leaflet (as shown in fig. 6 b), at this time, the two first connecting rods 410 and the driving rod 100 are in an I-shape or a symmetrical V-shape, and the two second connecting rods 420 and the driving rod 100 are in a symmetrical V-shape; after lifting and clamping the valve leaflets, the axial length of the driving rod 100 between the connecting member and the driving slider 210 is reduced and gradually approaches 0, when the included angle θ between the two first connecting rods 410 is 0 ° to 20 °, the clamping and lifting structure is closed, and at this time, the valve leaflets are closed to realize the edge-to-edge technology (as shown in fig. 6 c).

In conclusion, the utility model provides the valve repair device, the valve repair system and the working method thereof, the lifting component of the valve repair device can lift, clamp and lock the valve leaflets at any angle of 0-360 degrees, and the valve leaflets can be independently clamped or simultaneously clamped, so that the flexibility and the convenience of operation of a doctor are greatly improved. Meanwhile, in the operation process, if the valve repair device catches the chordae tendineae, the structure is flexible, larger included angles and smaller diameters can be achieved in the opening state, and the valve repair device is easy to disengage.

In addition, it should be noted that the terms "first" and "second" in the specification are only used for distinguishing each component, element, step and the like in the specification, and are not used for indicating a logical relationship or a sequential relationship between each component, element, step and the like, unless otherwise specified or indicated.

It is to be understood that while the present invention has been described in conjunction with the preferred embodiments thereof, it is not intended to limit the utility model to those embodiments. It will be apparent to those skilled in the art from this disclosure that many changes and modifications can be made, or equivalents modified, in the embodiments of the utility model without departing from the scope of the utility model. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention are still within the scope of the protection of the technical solution of the present invention, unless the contents of the technical solution of the present invention are departed.

Claims

1. The valve repair device is characterized by comprising a stopping structure, a driving rod and a clamping and lifting structure, wherein the driving rod is axially movably arranged in the stopping structure in a penetrating way, the near end of the driving rod is detachably connected with the far end of a conveying catheter, and the stopping structure is positioned at the near end of the driving rod and used for switching the axial movement state and the locking state of the driving rod;

2. The valve repair device of claim 1, wherein the clamping member includes two clamping jaws, the lifting member includes two first connecting rods and two second connecting rods, one end of each of the first connecting rods and one end of one of the second connecting rods are rotatably connected, the other end of each of the first connecting rods is rotatably connected to the distal end of the stopper structure, the other end of each of the second connecting rods is rotatably connected to the distal end of the driving rod, each of the clamping jaws is disposed on one of the first connecting rods, the clamping jaws cooperate with the first connecting rods to clamp the valve leaflets, and the lifting member changes the shape of the combination of the first connecting rods and the second connecting rods by axial movement of the driving rod.

3. The valve repair device of claim 2, wherein the included angle between the two first connecting rods is between 0 ° and 360 °.

4. The valve repair device of claim 3,

when the included angle between the two first connecting rods is 0-20 degrees, the clamping and lifting structure is used for folding the valve leaflets;

5. The valve repair device of claim 3,

when the included angle of the two first connecting rods is 0-360 degrees, the clamping component clamps the valve leaflets.

6. The valve repair device of claim 5, wherein the gripping member grips the leaflet when the angle between the two first connecting rods is between 90 ° and 180 °.

7. The valve repair device of claim 2, wherein both of the first and second connecting rods are symmetrically disposed on opposite sides of the drive rod.

8. The valve repair device of claim 2, wherein the two first connecting rods, the two jaws, and the two second connecting rods are each symmetrically disposed on either side of the drive rod.

9. The valve repair device of claim 2, wherein the material of the first and second connecting rods is a rigid material and the material of the jaws is an elastic or super-elastic material.

10. The valve repair device of claim 9, wherein the clamping jaw includes a stationary portion and a movable portion, the stationary portion and the movable portion being connected and having a negative included angle, the movable portion being rotatable about the stationary portion and rotating the movable portion such that a spring-back force is generated between the stationary portion and the movable portion when the included angle between the stationary portion and the movable portion is greater than or equal to 0 °, and the spring-back force increases with increasing included angle.

11. The valve repair device of claim 10, wherein one end of the fixation portion and one end of the movable portion are connected to form a connection end, the fixation portion has a first free end disposed opposite to the connection end, the movable portion has a second free end disposed opposite to the connection end, the fixation portion is fixed to the first connection rod, the connection end is disposed near the driving rod, the movable portion is attached to one side of the first connection rod near the proximal end, an included angle between the fixation portion and the movable portion is 0 °, and a resilient force is provided between the movable portion and the fixation portion.

12. The valve repair device of claim 11, wherein the second free end has a through hole for connecting to a distal end of a pull wire, wherein when the proximal end of the pull wire provides a pulling force, the second free end rotates away from the first free end with the pulling force, and the resilient force between the movable part and the stationary part increases with the rotation of the movable part.

13. A valve repair system comprising a valve repair device according to any one of claims 1 to 12, and a delivery device comprising a delivery catheter having a distal end detachably connected to a proximal end of the drive rod, the delivery catheter and the drive rod being axially movably inserted into the stop structure, and the lifting member being configured to change shape to release, lift, clamp and close chordae tendineae when the drive rod is axially moved by the delivery catheter.