CN116196144A - Valve repair device, valve repair system and working method of valve repair system - Google Patents

Abstract

The invention provides a valve repair device, a valve repair system and a working method thereof, wherein the lifting parts are of rigid structures, the proximal ends of the lifting parts are rotatably connected to the distal ends of the stopping structures, the distal ends of the lifting parts are rotatably connected to the distal ends of the driving rods, and the lifting parts are used for changing the shapes of the lifting parts through the axial movement of the driving rods, so that the lifting parts can realize the clamping of flaps She Tuoju and valve leaflets and the release of chordae tendineae at 0-360 degrees, the number of product specifications is reduced, the flexibility and the convenience of doctor operation are greatly improved, and meanwhile, if the valve repair device is used for hanging chordae tendineae in an operation process, the structure can realize larger included angles and smaller diameters in an opening state because of flexibility, and the release is easier.

Description

Valve repair device, valve repair system and working method of valve repair system

Technical Field

The invention relates to the technical field of medical equipment, in particular to a heart valve repair device, a heart valve repair system and a working method thereof, and valve repair is realized 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 damaged by congenital malformations, inflammatory processes, infection conditions, diseases, etc., resulting in reduced effectiveness of the heart valve, which may lead to serious cardiovascular damage or death. The damaged heart valve may be repaired or replaced by open heart surgery. However, open heart surgery is highly invasive, which may cause complications. Transcatheter interventional vascular techniques can introduce and implant prosthetic devices in a much less invasive manner than direct-view cardiology. The valve repairing device is mainly applied to transcatheter interventional vascular technology, realizes valve edge-to-edge repairing through a catheter, and has small trauma and quick recovery compared with the traditional operation.

The current edge-to-edge interventional repair device has complex structure or functional defects. Such as the Mitraclip product. The two clamping jaws of the Mitraclip product are integrally connected and are one part, so that the clamping jaws can easily cause poor clamping effect when facing different patient groups due to limited clamping angles of the two clamping jaws when clamping the valve leaflet, and can easily cause the implant to wind or clamp related tissues (such as chordae tendineae) when positioning or recovering the implant. For example, the Pascal product, the lifting mechanism adopts a flexible lifting structure, so that the conveying length of the repairing device is long, the conveying length of the repairing device is not favorable for vascular conveying, the reliability of the stopping structure through elastic locking is not high, the clamping area of the valve leaflet is overlarge, and the like.

Disclosure of Invention

The invention aims to provide a valve repair device, a valve repair system and a working method thereof, which can have good valve leaflet clamping effect, improve the use convenience of products, reduce the number of specifications of the products, enlarge the indication of the products and reduce the operation difficulty.

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

the clamping and lifting structure comprises a clamping component and a lifting component, wherein the lifting component is of a rigid structure, the clamping component is arranged at the proximal end of the lifting component and is used for being matched with the lifting component to clamp the valve leaflet, the proximal end of the lifting component is rotatably connected with the distal end of the stopping structure, the distal end of the lifting component is rotatably connected with the distal end of the driving rod and is used for enabling the shape of the lifting component to change through axial movement of the driving rod, and the lifting component can achieve valve She Tuoju, valve leaflet clamping and tendon releasing under the condition of 0-360 degrees.

Optionally, the clamping part includes two clamping jaws, the lifting part includes two head rods and two second connecting rods, every the one end of head rod and one after the one end rotatable coupling of second connecting rod, every the other end of head rod with the distal end rotatable coupling of locking structure, every the other end of second connecting rod with the distal end rotatable coupling of actuating lever, every the clamping jaw sets up respectively on the head rod, the clamping jaw with the head rod cooperation is used for the centre gripping lamella, the lifting part passes through the axial motion of actuating lever changes the shape that head rod and second connecting rod constitute changes.

Further, the included angle between the two first connecting rods is 0-360 degrees.

Further, 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 the valve leaflets; and

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

Further, when the included angle between the two first connecting rods is 0-360 degrees, the clamping part clamps the valve leaf.

Further, when the included angle between the two first connecting rods is 90-180 degrees, the clamping part clamps the valve leaf.

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

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

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

Further, the clamping jaw comprises a fixed part and a movable part, the fixed part is connected with the movable part and is provided with a negative included angle, the movable part can rotate around the fixed part and rotate the movable part, so that when the included angle between the fixed part and the movable part is larger than or equal to 0 degree, a rebound force is generated between the fixed part and the movable part, and the rebound force is increased along with the increase of the included angle.

Further, one end of the fixed portion and one end of the movable portion are connected to form a connecting end, the fixed portion has a first free end which is opposite to the connecting end, the movable portion has a second free end which is opposite to the connecting end, the fixed portion is fixed on the first connecting rod, the connecting end is close to the driving rod, the movable portion is attached to one side of the first connecting rod, which is close to the proximal end, an included angle between the fixed portion and the movable portion is 0 degrees, and resilience force is provided between the movable portion and the fixed portion.

Further, the second free end has a through hole, the through hole is used for connecting the distal end of acting as go-between, when the proximal end of acting as go-between provides the tractive force, the second free end is kept away from along with the tractive force first free end, and rotates, along with the rotation of movable portion, the resilience force between movable portion and the fixed portion increases.

In another aspect, the present invention provides a valve repair system, including 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 a driving rod, the delivery catheter and the driving rod are axially movably disposed in a stop structure, and when the delivery catheter drives the driving rod to axially move, a shape of the lifting component is changed, so as to implement chordae detachment, flap She Tuoju, clamping and folding.

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 component is released from the wound chordae tendineae;

the driving rod moves axially, and simultaneously applies traction force to the two clamping jaws, so that 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 lifting component captures the valve leaflet, and the traction force of the two clamping jaws is withdrawn, so that the two clamping jaws respectively clamp the valve leaflet with one first connecting rod at the same time; 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 She Gelong realizes the edge-to-edge technology.

Compared with the prior art, the invention has the following technical effects:

the invention provides a valve repair device, a valve repair system and a working method thereof, wherein the lifting part is of a rigid structure, the proximal end of the lifting part is rotatably connected with the distal end of the stopping structure, the distal end of the lifting part is rotatably connected with the distal end of the driving rod and is used for enabling the shape of the lifting part to change through the axial movement of the driving rod, so that the lifting part can realize the clamping of a valve She Tuoju and a valve leaflet and the release of chordae tendineae at 0-360 degrees, the flexibility and the convenience of doctor operation are greatly improved, and meanwhile, if the valve repair device is hung on a chordae tendineae in an operation process, the structure can realize a larger included angle and a smaller diameter in an opening state because of flexibility, and is easier to release.

Further, through the second free end has the through-hole, the through-hole is used for connecting the distal end of acting as go-between, when the proximal end of acting as go-between provides the tractive force, the second free end is kept away from along with the tractive force first free end, and rotates, along with the rotation of movable portion, the resilience force between movable portion with fixed portion increases, 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 the two sides of the driving rod respectively, so that the whole structure adopts a completely symmetrical design, the types of the related parts are fewer, the technological process is reduced, and the mass production is facilitated.

Drawings

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

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

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

FIG. 3 is a schematic view illustrating a structure of a first connecting rod according to an embodiment of the present invention;

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

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

fig. 6a-6c are schematic structural views of a lifting member under different conditions according to an embodiment of the present invention.

Reference numerals illustrate:

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

100-driving rod;

200-stop structure; 210-driving a slider; 211-a first sidewall; 212-a second sidewall; 220-locking member;

300-jaw members; 310-clamping jaw; 310 a-a connection end; 311-fixing part; 311 a-a first free end; 312-a movable portion; 312 b-a second free end; 313-a second opening; 314-opening; 315-through holes; 316-barbs;

400-lifting the component; 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-a first opening; 415-a first hinge hole; 420-a second connecting rod; 420 a-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-notch; 428-second suture hole.

Detailed Description

The invention provides a valve repairing device, which comprises a stop structure, a driving rod and a clamping lifting structure, wherein the driving rod is axially movably arranged in the stop structure in a penetrating way, the proximal end of the driving rod is detachably connected with the distal end of a conveying catheter, and the stop structure is positioned 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, wherein the lifting component is of a rigid structure, the clamping component is arranged at the proximal end of the lifting component and is used for being matched with the lifting component to clamp the valve leaflet, the proximal end of the lifting component is rotatably connected with the distal end of the stopping structure, the distal end of the lifting component is rotatably connected with the distal end of the driving rod and is used for enabling the shape of the lifting component to change through axial movement of the driving rod, and the lifting component can achieve valve She Tuoju, valve leaflet clamping and tendon releasing under the condition of 0-360 degrees.

On the other hand, the invention also provides a valve repair system, which comprises the valve repair device and a delivery device, wherein the delivery device comprises a delivery catheter, the distal end of the delivery catheter is detachably connected with the proximal end of a driving rod, the delivery catheter and the driving rod can be axially movably penetrated in a stop structure, and when the delivery catheter drives the driving rod to axially move, the shape of the lifting part is changed so as to realize tendon release, flap She Tuoju, clamping and folding.

In yet another aspect, the present invention also provides a method of operating a valve repair system, including the valve repair system, the method 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 component is released from the wound chordae tendineae;

the driving rod moves axially, and simultaneously applies traction force to the two clamping jaws, so that 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 lifting component captures the valve leaflet, and the traction force of the two clamping jaws is withdrawn, so that the two clamping jaws respectively clamp the valve leaflet with one first connecting rod at the same time; 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 She Gelong realizes the edge-to-edge technology.

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

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 invention in unnecessary detail. It should be appreciated that in the development of any such actual embodiment, numerous implementation details must be made to achieve the developer's specific goals, such as compliance with system-related or business-related constraints, which will vary from one implementation to another. In addition, 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 accompanied with figures are described in detail below. It is noted that the drawings are in a very simplified form and utilize non-precise ratios, and are intended to facilitate a convenient, clear, description of the embodiments of the invention. The term "or" is used herein generally in the sense of including "and/or" unless the content clearly indicates otherwise. The terms "inner", "outer", and the like are used herein for illustrative purposes only and do not represent the only embodiment. As used herein, the terms "distal" and "proximal" are relative orientations, relative positions, directions of elements or actions relative to one another from the perspective of a physician using the medical device, although "distal" and "proximal" are not intended to be limiting, and "proximal" generally refers to an end of the medical device that is proximal to an operator during normal operation, and "distal" generally refers to an end that is proximal to a heart of a patient.

Fig. 1a is a schematic structural diagram of a valve repair system according to the present embodiment. Fig. 1b is an enlarged schematic view of the area a in fig. 1. As shown in fig. 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 functions of loading, delivery, release and the like during delivery; the second handle 32 is connected to the proximal end of the inner sheath catheter 22 and is used to control the controlled bending of the distal end of the inner sheath catheter 22 to create a minimally invasive access path during delivery; the third handle 33 is connected to the proximal end of the outer sheath catheter 23 and is used to control the controlled 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, the driving rod 100 is axially movably inserted in the stopping structure 200, the stopping structure 200 is located at a proximal end of the driving rod 100, and the clamping and lifting structure is rotatably connected with a distal end of the driving rod 100 and is also rotatably connected with 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 part with the stopping structure 200 and a connection part with the driving rod 100, thereby driving the shape of the clamping and lifting structure to change, so as to lift and clamp the valve leaflet.

The stop structure 200 includes a driving slider 210 and a locking member 220 disposed in the driving slider 210, where the driving rod 100 is inserted into the driving slider 210 and the locking member 220, so that during the conveying process, the conveying pipe 21 drives the driving rod 100 to move axially in the driving slider 210, and the locking member 220 switches the axial movement state and the locking state of the driving rod 100 to switch the release state and the locking state of the clamping lifting structure.

The driving slider 210 includes a proximal portion and a distal portion sequentially from a proximal end to a distal end along an axial direction, the proximal portion is substantially tubular, the distal portion includes a first side wall 211 and a second side wall 212 that are disposed opposite to each other, and proximal ends of the first side wall 211 and the second side wall 212 are both connected to distal ends of the proximal portion, preferably, the first side wall 211 and the second side wall 212 are disposed in parallel.

The clamping and lifting structure is used for lifting and clamping the valve leaflet, the clamping and lifting structure comprises a lifting component 400 and a clamping jaw component 300, the clamping jaw component 300 is arranged on the lifting component 400, the lifting component 400 is rotatably connected with the distal end part of the driving sliding block 210 and is used for lifting the valve leaflet, in detail, the lifting component 400 is rotatably connected with the first side wall 211 and the second side wall 212, and the clamping jaw component 300 is used for clamping the valve leaflet in a matching way with the lifting component 400.

The lifting part 400 includes two first connecting rods 410 and two second connecting rods 420, the two first connecting rods 410 each include a first end 410a and a second end 410b, the two second connecting rods 420 each include a first end 420a and a second end 420b, the second end 410b of each first connecting rod 410 is rotatably connected to the second end 420b of one second connecting rod 420, the first ends 410a of the two first connecting rods 410 are rotatably connected to the first side wall 211 and the second side wall 212 of the distal end portion at the same time, and one first connecting rod 410 and the second connecting rod 420 connected to each other and the other first connecting rod 410 and the second connecting rod 420 connected to each other are symmetrically disposed at both sides of the driving rod 100. In detail, a connection portion is fixed at the distal end of the driving rod 100, the connection portion is fixed at the distal end of the driving rod 100, two ears are provided on two sides of the driving rod 100 in the radial direction, and the first end 420a of each second connecting rod 420 is symmetrically and rotatably connected to one ear. The bracket structure changes the 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 sliding block 210 (namely, the conveying conduit drives the driving rod 100 to axially slide in the driving sliding block 210), so as to promote the movement of the first connecting rod 410 and the second connecting rod 420, and finally realize that the first connecting rod 410 and the second connecting rod 420 are in different postures (namely, the lifting posture, the clamping posture and the like of the valve leaves). 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 piece are all hinged by hinges of connecting shafts, so as to realize 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 an included angle θ between the two first connecting rods 410 is 0 ° to 360 °, typically, when the included angle θ is 0 ° to 20 °, the clamping and lifting structure is closed, that is, the clamping and lifting structure folds the valve leaflet; when the included angle is 0-360 degrees, the clamping part clamps the valve leaflet, preferably, when the included angle theta is 90-180 degrees, the lifting part captures the most suitable state of the valve leaflet; when the included angle theta is 270-360 degrees, the lifting component is favorable for releasing after the chordae tendineae are wound. Wherein, the connecting shaft can realize hinge joint with other parts through riveting, welding and the like.

The axial length of the first connecting rod 410 is smaller than that of the second connecting rod 420, and two sets of the first connecting rods 410 and the 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 by the valve repairing device through the axis of the driving rod 100, and the function of folding the valve leaflet is realized after the valve leaflet is clamped.

Fig. 3 is a schematic structural diagram of a 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 are both located in the longitudinal direction of the first bottom wall 411. Each of the first connection walls 412 is provided with a first hinge hole 415 on the first end 410a and the second end 410b of the first connection rod 410, and the first hinge hole 415 is used for installing a connection shaft to form a hinge to hinge the first connection rod 410 and the driving slider 210 or the first connection rod 410 and the second connection rod 420. The first bottom wall 411 has a first notch 413 at the first end 410a of the first connecting rod 410, where the first notch 413 is, for example, a rectangular notch, used to avoid interference between the first connecting rod 410 and the driving slider 210 during rotation, and a plurality of first openings 414 are further provided on the first bottom wall 411, where the first openings 414 are used to stitch or bond the jaw members 300.

Fig. 4 is a schematic structural view 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 on the same side and opposite to each other, and are both located in the longitudinal direction of the second connecting walls 422. Each of the second connection walls 422 is provided with a second hinge through hole on the first and second ends 420a and 420b of the second connection rod 420 for mounting a connection shaft to form a hinge to hinge the second connection rod 420 and the driving rod 100 or the second connection rod 420 and the first connection rod 410, and the first and second hinge holes 415 and 426 to hinge the second connection rod 420 and the first connection rod 410 are disposed opposite to each other. The second bottom wall 421 has a second notch 423 at a first end 420a of the second connecting rod 420, and a third notch 424 at a second end 420b, where the second notch 423 and the third notch 424 are, for example, rectangular notches, and the second notch 423 and the third notch 424 are both 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 suture holes 425, a second suture hole 428 is disposed between the second hinge through holes at two ends of the second connecting wall 422, and the first suture holes 425 and the second suture holes 428 are used for suture fixation or adhesive fixation of 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 avoid interference between the first connecting rod 410 and the second connecting rod 420 when rotating. In addition, in order to avoid interference, the profiles of the first connecting rod 410 and the second connecting rod 420 are formed into rigid parts by punching, die casting, bending, or the like. The long direction is the direction in which the left and right directions in fig. 3 and 4 are located.

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

With continued reference to fig. 5, in the present embodiment, the clamping jaw 310 includes a fixed portion 311 and a movable portion 312, and a connecting end 310a for connecting the fixed portion 311 and the movable portion 312 is provided between 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, stitching, bonding, integrally cutting, and the like. The fixed portion 311 is elongated and has a first free end 311a disposed opposite to the connection end 310a, the movable portion 312 is also elongated and has a second free end 312b disposed opposite to the connection end 310a, the movable portion 312 may rotate around the fixed portion 311 around the connection end 310a as a center, the connection end 310a is defined as a center, the direction of the connection end 310a toward the first free end 311a is defined as a starting point position, i.e., a 0 ° position, and the first free end 311a is defined as a starting point in a positive angular rotation direction along a counterclockwise direction a, and the first free end 311a is defined as a negative angular direction along a clockwise direction, at this time, the movable portion 312 is located in a negative angular position, i.e., an included angle between the movable portion 312 and the fixed portion 311 is a negative value, and the movable portion 312 may rotate around the connection end 310a in the counterclockwise direction by an angle of-180 ° to 270 °, preferably, and the rotation angle is 180 ° to 45 °. The movable portion 312 has an opening 314, the opening 314 being provided in a long direction of the movable portion 312, the fixed portion 311 being located in the opening 314 when the movable portion 312 is rotated to overlap the fixed portion 311 and the movable portion 312, the opening 314 allowing the movable portion 312 to pass through an overlapping position of the fixed portion 311 from an outside thereof when rotated.

When the fixed portion 311 is fixed to the first connecting rod 410, the movable portion 312 is rotated clockwise, so that an included angle between the fixed portion 311 and the movable portion 312 is greater than or equal to 0, and then one side of the fixed portion 311 facing away from the rotation direction is fixed to the first connecting rod 410 by welding, stitching, bonding, or the like, at this time, due to rotation of the movable portion 312, elastic deformation resilience force is provided between the movable portions 312, so that the movable portions 312 are attached to the first bottom wall 411, the connecting end 310a is close to the first end 410a of the first connecting rod 410, the first free end 311a and the second free end 312b are close to the second end 410b of the first connecting rod 410, and a mutual extrusion force is provided between the movable portion 312 and the first bottom wall 411, so as to facilitate providing a powerful clamping force when the clamping jaw 310 clamps a leaflet.

The fixing portion 311 is formed with a plurality of second openings 313, and the second openings 313 are overlapped with the first openings 414 and are used together to fix 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, where the through hole is used to provide a pulling wire to provide a rotatable pulling force (a pulling force of the movable portion in a counterclockwise rotation direction AT in fig. 5) to the movable portion 312, so that the movable portion 312 of the overlapped movable portion 312 and the fixed portion 311 deforms relative to the fixed portion 311, and an included angle between the fixed portion 311 and the movable portion 312 is changed. The movable portion 312 is provided with a plurality of barbs 316 uniformly distributed at both ends perpendicular to the long direction to achieve better gripping of the leaflet. Each jaw 310 has a separate pull wire so that two jaws 310 can grip the leaflet simultaneously or separately.

The valve repair device further includes a cover that covers the outer side of the lifting member and is secured by sewing or bonding through the first and second sewing holes 425, 428. The primary material of the coating may be a braid of PET or PTFE. Because the clamping and lifting component is of a symmetrical structure, the valve repair device coated with the coating is also of a symmetrical structure. The number of parts of the whole structure is small, the process is small, and the mass production is facilitated.

During operation, the delivery catheter moves the drive rod 100 in the drive slide 210 of the stop arrangement 200 to change the shape of the lifting member by a change in the axial length of the drive rod 100 between the connector and the drive slide 210. First, the driving rod moves axially, so that the valve repair device is delivered when the included angle theta between the two first connecting rods is 0-20 degrees. After delivery to the target site, there are more chordae under the mitral valve leaflet, mainly centered on the underside of A1P1 and A3P3, depending on the actual anatomy. When lifting the valve leaflet, the first connecting rod 410 is likely to be entangled with the native chordae, and at this time, the valve repair device may need to be withdrawn from below the valve leaflet (left ventricle) to above the valve leaflet (left atrium), so that the axial length of the driving rod 100 between the connecting piece and the driving slider 210 is required to be increased and gradually approaches 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 component may be released from the entangled chordae (as shown in fig. 6 a), at this time, each of the clamping jaws 310 may be attached to the first connecting rod 410 to which it is fixed, and the second free end 312b may also be disposed near the proximal end of the driving rod 100 by a pull wire, and the external dimension d of the lifting component in the radial direction of the driving rod 100 is reduced as the included angle θ between the two first connecting rods 410 approaches 360 °, so that the lifting component may be easily withdrawn from the chordae; when the lifting members are required to lift the leaflet after the leaflet is released from the chordae, each clamping jaw 310 is pulled to enable the second free end 312b to be close to the proximal end of the driving rod 100, and the axial length of the driving rod 100 between the connecting piece and the driving sliding block 210 is gradually reduced so as to capture the leaflet, wherein when the included angle between the two first connecting rods is 0-360 degrees, the clamping members clamp the leaflet, and the most suitable state of capturing the leaflet (i.e. the state that the clamping members are easier to clamp the leaflet) is that the included angle θ between the two first connecting rods 410 is 90-180 degrees, the angle can prevent the leaflet from slipping in the folding process, and the pulling force provided by the pulling wires is withdrawn, so that the movable part 312 rebounds and clamps the 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-type or 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 leaflet, the axial length of the driving rod 100 between the connecting piece and the driving sliding block 210 is reduced, and when the included angle θ between the two first connecting rods 410 is 0 ° to 20 ° gradually approaching to 0 °, the clamping and lifting structure is closed, and the valve She Gelong is closed at this time to realize the edge-to-edge technology (as shown in fig. 6 c).

In summary, the invention provides a valve repair device, a valve repair system and a working method thereof, wherein the lifting component of the valve repair device can clamp and lock the valve She Tuoju and the valve leaflet at any angle of 0-360 degrees, and the valve leaflet can be independently clamped or simultaneously clamped, so that the flexibility and convenience of operation of doctors are greatly improved. Meanwhile, in the operation process, if the chordae tendineae are hung by the valve repairing device, the valve repairing device is flexible, can realize larger included angle and smaller diameter in the opening state, is easier to release, and the whole structure adopts a completely symmetrical design, so that the types of the related parts are fewer, the technological process is reduced, and the valve repairing device is more beneficial to mass production.

In addition, unless specifically stated or indicated otherwise, the terms "first" and "second" in the specification are used merely to distinguish between components, elements, steps, etc. in the specification and do not denote a logical or sequential relationship between the components, elements, steps, etc.

It will be appreciated that although the invention has been described above in terms of preferred embodiments, the above embodiments are not intended to limit the invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.

Claims (14)

1. The valve repair device is characterized by comprising a stop structure, a driving rod and a clamping lifting structure, wherein the driving rod is axially movably arranged in the stop structure in a penetrating way, the proximal end of the driving rod is detachably connected with the distal end of a conveying catheter, and the stop structure is positioned 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, wherein the lifting component is of a rigid structure, the clamping component is arranged at the proximal end of the lifting component and is used for being matched with the lifting component to clamp the valve leaflet, the proximal end of the lifting component is rotatably connected with the distal end of the stopping structure, the distal end of the lifting component is rotatably connected with the distal end of the driving rod and is used for enabling the shape of the lifting component to change through axial movement of the driving rod, and the lifting component can achieve valve She Tuoju, valve leaflet clamping and tendon releasing under the condition of 0-360 degrees.

2. The valve repair device of claim 1, wherein the clamping member comprises two clamping jaws, the lifting member comprises two first connecting rods and two second connecting rods, one end of each first connecting rod is rotatably connected with one end of one second connecting rod, the other end of each first connecting rod is rotatably connected with the distal end of the stopping structure, the other end of each second connecting rod is rotatably connected with the distal end of the driving rod, each clamping jaw is respectively arranged on one first connecting rod, the clamping jaws are matched with the first connecting rods to clamp the valve leaflet, and the lifting member changes the shape formed by the first connecting rods and the second connecting rods through axial movement of the driving rod.

3. The valve repair device of claim 2, wherein an 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;

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

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

5. The valve repair device of claim 3,

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

6. The valve repair device of claim 5, wherein the clamping member clamps the leaflet at an angle of 90 ° to 180 ° between the two first connecting rods.

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

8. The valve repair device of claim 2, wherein the two first connecting rods, the two clamping jaws, and the two second connecting rods are symmetrically disposed on both sides of the driving rod, respectively.

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 jaw comprises a fixed portion and a movable portion, the fixed portion and the movable portion being connected and having a negative angle, the movable portion being rotatable about the fixed portion and rotating the movable portion such that a spring force is generated between the fixed portion and the movable portion when the angle between the fixed portion and the movable portion is greater than or equal to 0 °, and the spring force increases with increasing angle.

11. The valve repair device of claim 10, wherein one end of the fixed portion and one end of the movable portion are connected to form a connection end, the fixed 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 fixed portion is fixed to the first connection rod, the connection end is disposed adjacent to the driving rod, the movable portion is disposed on a side of the first connection rod adjacent to the proximal end in a fitting manner, an included angle between the fixed portion and the movable portion is 0 °, and a rebound force is provided between the movable portion and the fixed portion.

12. The valve repair device of claim 11, wherein the second free end has a through hole for connecting a distal end of a pull wire, the second free end being rotated away from the first free end with the pull force when the proximal end of the pull wire provides the pull force, the resiliency between the movable portion and the fixed portion increasing with rotation of the movable portion.

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, the distal end of the delivery catheter being detachably connected to the proximal end of the drive shaft, the delivery catheter and drive shaft being axially movable through a stop structure, and the lifting member being shaped to change to effect chordae break-off, petals She Tuoju, clamping and folding as the delivery catheter moves the drive shaft axially.

14. A method of operating a valve repair system comprising the valve repair system of claim 13, the method 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 component is released from the wound chordae tendineae;

the driving rod moves axially, and simultaneously applies traction force to the two clamping jaws, so that 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 lifting component captures the valve leaflet, and the traction force of the two clamping jaws is withdrawn, so that the two clamping jaws respectively clamp the valve leaflet with one first connecting rod at the same time; 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 She Gelong realizes the edge-to-edge technology.

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