CN214387783U

CN214387783U - Repair system for preventing valve regurgitation

Info

Publication number: CN214387783U
Application number: CN202023075769.XU
Authority: CN
Inventors: 吕世文; 陈志�; 陈进雄
Original assignee: Jenscare Scientific Co Ltd
Current assignee: Jenscare Scientific Co Ltd
Priority date: 2020-12-18
Filing date: 2020-12-18
Publication date: 2021-10-15
Anticipated expiration: 2030-12-18

Abstract

The utility model relates to the field of medical equipment, especially, relate to a repair system for preventing valve regurgitation, including control handle and conveying pipe, conveying pipe includes leaflet catching device and pressure valve spare, the distal end of leaflet catching device is equipped with leaflet catching platform, the distal end portion of pressing valve spare sets up the distal end side of leaflet catching platform, when autologous leaflet is located between leaflet catching platform and the distal end portion of pressing valve spare, the distal end portion of pressing valve spare from the distal end side of leaflet catching platform to when the proximal end side of leaflet catching platform moves, autologous leaflet forms the overlap region in the proximal end side of leaflet catching platform; the utility model discloses simple structure, the pre-installation degree of difficulty is low, and whole operation flow is simple, has greatly simplified the flow of repairing the operation, has further reduced the required time of operation, is favorable to patient's postoperative rehabilitation.

Description

Repair system for preventing valve regurgitation

Technical Field

The utility model relates to the field of medical equipment, especially, relate to a repair system for preventing valve regurgitation.

Background

The mitral valve is located at the left atrioventricular orifice and is composed of five parts, an annulus, leaflets, chordae tendineae, papillary muscles, and an interfacing junction, which are anatomically known by the exact name mitral valve device (mitral apex) or mitral valve complex (mitral complex).

The tricuspid valve is located at the right atrioventricular orifice and has three approximately triangular sail-like valves, the valve base of which is attached to the fibrous annulus of the atrioventricular orifice, and the fibrous annulus, the valve, the chordae tendineae and the papillary muscles are functionally visualized as a tricuspid valve complex.

Mitral regurgitation (mitral regurgitation) can be classified into the following two categories: 1. the rheumatic mitral regurgitation of the heart, mainly caused by mitral insufficiency, can cause the blood to flow reversely, thus mixing different blood, causing the blood pumping and oxygen delivery functions of the heart to be reduced. 2. Non-rheumatic mitral regurgitation, in addition to rheumatic valvular lesions, is commonly referred to as mitral regurgitation to varying degrees due to abnormalities in the mitral valve itself and its surrounding anatomy. The causes of non-rheumatic mitral insufficiency are many, and the common causes are: mitral valve prolapse, papillary muscle insufficiency or chordae tendineae rupture, left atrial myxoma, calcification of the valve annulus, congenital valve malformations, infectious endocarditis, and the like. Mitral regurgitation can also be classified into three types, functional, degenerative or mixed. Most common are degenerative and functional mitral regurgitation. Functionality is typically secondary to impaired left ventricular wall motor function, left ventricular dilatation, papillary muscle dysfunction, commonly found in heart failure patients. This segment of patients also included ischemic mitral regurgitation secondary to coronary heart disease and mitral regurgitation associated with non-ischemic cardiomyopathy. Degenerative mitral regurgitation disease is generally considered to be a pathological change in the structure of the valve, or a pathological change in the structure under the valve, including abnormal extension or rupture of the chordae tendineae.

The regurgitation of the tricuspid valve is generally caused by pulmonary hypertension, right ventricle enlargement and tricuspid valve annulus expansion, and after the regurgitation of the tricuspid valve, the symptoms of right heart failure such as hypodynamia, ascites, edema, liver pain, dyspepsia, anorexia and the like are aggravated. Tricuspid insufficiency is largely classified into functional and organic tricuspid insufficiency. The organic insufficiency of the valve caused by rheumatic fever is few, and the functional insufficiency is most, and the most common causes are the expansion of the right ventricle caused by pulmonary hypertension and the enlargement of the tricuspid valve ring, which cause the relative insufficiency of the tricuspid valve and the normal structure of the valve. Such as rheumatic mitral valve disease, congenital cardiovascular disease, pulmonary heart disease, etc.

Conventional treatment for mitral and tricuspid valve regurgitation include medications for mild to severe regurgitation, and surgical procedures with corresponding surgical indications. Among the surgical methods are mitral valve, tricuspid valve replacement, and mitral valve and tricuspid valve repair. With pure mitral regurgitation, only 30% of patients need mitral valve replacement, and the rest only need mitral valve repair. In surgical procedures, typical open chest, open heart surgery is too invasive, requiring extracorporeal circulation to be established, with a high incidence of complications and risk of infection. In order to reduce the risk of surgery, transcatheter invasive replacement and repair surgical methods have been developed.

According to the literature [ Enriquez-Sarano M, Schaff HV, Orszulak TA, et al.valve repair improves the output of surgery for peripheral regulation: a multivariate analysis [ J ] Circulation, 1995, 91 (4): 1022-1088 reports that replacement has a higher overall operative mortality and a lower survival rate. The problems to be solved at present in the transcatheter treatment of valve regurgitation include the following: the implantation amount of the implant is reduced on the premise of ensuring the effect of preventing backflow as much as possible; the devices that block reflux must be accurately positioned and firmly secured at the site requiring treatment; instruments that block flow need to minimally affect the movement of the remaining leaflets with normal function; the apparatus for preventing regurgitation needs to adapt to the difference of the physiological structure of the valve annulus, and the technical points of different apparatus for preventing regurgitation in the prior art are listed below.

In patent CN103338726A, a method for treating mal-coaptation of a heart valve of a patient is described, the method comprising introducing an implant into the heart while the implant is in a first configuration, deploying the implant from the first configuration to a second configuration within the heart, the implant in the second configuration having a coaptation assist body with first and second opposing coaptation surfaces, and supporting the deployed implant such that the coaptation assist body is offset from the axis of the heart valve along the coaptation region, in which claim the method further comprises: selectively deploying a first anchor at a first target location proximate to the first union (the first union being at a first junction of first and second leaflets carried by the heart valve), selectively deploying a second anchor at a second target location proximate to the second union (the second union being at a second junction of the first and second leaflets carried by the heart valve), introducing a coaptation assist body into the heart, in another claim, the implant is described as including an coaptation assist body having an axis and first and second opposing primary coaptation surfaces each extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, a first anchor, and a second anchor, the first anchor being selectively deployable at the first target location proximate to the heart of the first union, such that said first lateral edge is oriented toward said first union, and thereafter further defines an anchoring location for said second anchor proximate said second union. In another claim it is further particularly defined that the axis of the implant is intended to extend along the valve axis and that the first and second side edges of the coaptation assist body are intended to extend along a curve of the coaptation region of the heart valve, wherein the coaptation assist body of the supported implant is sufficiently laterally compliant such that coaptation between the implant and the heart causes the coaptation assist body between the edges to bend laterally towards the curve defined by the coaptation region of the heart valve. The above claims define that the anchoring position needs to be close to the first and second junctions, and that the entire coaptation assist body needs to be substantially laterally conformable to the heart valve. This technique, which is not adapted to partial valve prolapse, has the drawback of exerting the effect of preventing regurgitation, firstly, that "supporting the deployed implant so that the coaptation assist body is offset from the axis of the heart valve along the coaptation region" described in this utility model means that when the implant is naturally deployed, the coaptation assist body is reduced along the center line, which requires the coaptation assist body to be shaped into a cone, and secondly, the coaptation assist body covers the normal valve that has not prolapsed, and during long-term movement, adhesion is easily caused, sacrificing the normal function of a part of the normal valve; thirdly, the autologous valve towards the direction between hearts close to the autologous valve ring has smaller movement amplitude than the valve leaflets close to the valve cusps during opening and closing processes, is easy to adhere to the heart valve auxiliary body which is fully transversely conformed and is attached to the valve cusps, and is different from the upper coaptation auxiliary body, namely the valve ring, the valve ring is in long-term implantation and should grow together with the autologous valve ring to increase the fixed effect, and the autologous valve towards the direction between hearts close to the autologous valve ring once causes adhesion, influences the movement effect of the valve leaflets and easily causes secondary regurgitation, thus failing to prevent regurgitation treatment; fourth, the size of the native valve annulus varies from person to person, resulting in more product specifications in the technology.

Patent US20130325110a1 describes a method of treating mitral and tricuspid regurgitation by delivering a leaflet closing prosthesis without beating, said method comprising anchoring a ventricular anchor from the atrium through the native valve into the right ventricle, delivering and adjusting the position of the prosthesis at the tricuspid annulus using a catheter until regurgitation is reduced, fixing the catheter relative to the flexible track and fixing it to the inferior vena cava. Although the position of the prosthesis can be adjusted to adapt to different reflux positions by the delivery method, the prosthesis has certain pathological adaptability, but the fixed position of the inferior vena cava is far away from the valve ring position, so that the fixation is easy to be unstable, and the prosthesis is displaced after the fixation is finished.

The utility model discloses a repair system for preventing valve regurgitation, simple structure, convenient operation can deal with the pathological change of various different degrees and positions, can be used to the treatment mitral valve leaflet prolapse.

SUMMERY OF THE UTILITY MODEL

The utility model aims at overcoming the defects of the prior art, and providing a repair system for preventing valve regurgitation for patients who need intervention treatment for mitral valve leaflet prolapse. Although the repair system that prevents valve regurgitation among the prior art has obtained certain effect in the aspect of preventing the regurgitation, the repair system structure is more complicated, can't adapt to the physiology structure of leaflet to the anchoring piece is infirm in the portion of pricking into of toughness tissue position in the heart, easy slippage, the utility model discloses the implant volume of the repair system implant that prevents valve regurgitation is few, and anchoring unit location is accurate, and the anchoring is firm, and the delivery catheter diameter is little, and is easy and simple to handle, and anchoring device and delivery device cooperate well, safe and reliable, can deal with the pathological change of various different degrees and positions, can be used to the treatment cusp mitral valve prolapse.

In order to solve the technical problem, the utility model discloses a following technical scheme can solve:

a repair system for preventing valve regurgitation comprising a control handle and a delivery catheter, the delivery catheter comprising a leaflet capture device having a distal end with a leaflet capture platform and a compression member having a distal end portion disposed on a distal side of the leaflet capture platform, the native leaflet forming an overlap region on a proximal side of the leaflet capture platform when the native leaflet is positioned between the leaflet capture platform and the distal end portion of the compression member as the distal end portion of the compression member moves from the distal side of the leaflet capture platform to the proximal side of the leaflet capture platform.

The utility model discloses can also further realize through following technical scheme:

in one embodiment, an anchor and an anchor delivery device are further disposed within the delivery catheter, and when the leaflets form an overlap region between the valve pressing member and the leaflet capturing device, the control handle is operated such that a distal end of the anchor delivery device abuts the overlap region, and the anchor is moved distally by the anchor delivery device and penetrates the overlap region and is connected thereto.

In one embodiment, the overlapping regions are in a triangular configuration.

In one embodiment, the anchor delivery device includes a guide track, a piercing track disposed within the guide track, the anchor and pusher being disposed within the piercing track when pre-assembled, the piercing track having a sharpened distal end, the piercing track having a distal end that pierces and then passes through the overlap region, the anchor being pushed out through by the pusher.

In one embodiment, the anchor delivery device further comprises a guide wire, wherein guide holes are formed at two sides of the distal end of the guide rail, the guide holes are fixedly connected with the guide rail, when the guide wire is preassembled, one end of the guide wire is connected with a control handle, the other end of the guide wire passes through the guide holes and is connected with the leaflet catching platform, when the control handle is operated to enable the guide wire to be tensioned and locked, the leaflet catching platform, the guide rail and the guide wire are connected, so that the relative positions of the leaflet catching platform, the guide rail and the guide wire are fixed, the accurate positioning of the anchor is ensured, and the anchor is prevented from needing to find an anchor point in a large amount of time during a surgical process. And the anchoring piece penetrates through the overlapping area and is limited at one side of the overlapping area in a knotting mode.

In one embodiment, the most distal end of the guide rail and the most distal end of the puncture rail are both provided with a bending adjusting structure, the slit tube is made of a catheter-grade nickel-titanium tube with better elasticity, the slit tube has certain strength and can be partially bent, the distal end side of the anchor delivery device has a preset shape, and when the valve pressing element and the valve leaflet catching platform are operated to enable the valve leaflets to form an overlapping region, the guide wire is tensioned, so that the distal end portion of the anchor delivery device can be guided to the overlapping region of the valve leaflets, the anchor delivery device does not need to search for points again in the surgical process, the surgical time is saved, and the surgical success rate is improved.

In one embodiment, the guide wire is a flexible wire, is made of a high polymer material or a metal wire, has certain strength and toughness, is high in mobility, has high strength during tensioning connection, cannot affect other components during loosening, and reduces loading difficulty.

In one embodiment, the anchor may be a wire.

In another embodiment, the anchor may be an anchor needle.

In one embodiment, the capturing platform further comprises an auxiliary support device, the auxiliary support device is connected with the leaflet capturing platform, and the auxiliary support device can enlarge the radial area of the leaflet capturing platform and improve the stability and success rate of leaflet capturing.

In one embodiment, the leaflet capture device is a unitary closed loop structure with a distal portion of the leaflet capture device curved to form the leaflet capture platform.

In one embodiment, the flapper has a preset configuration, a distal portion of the flapper is bent, and the control handle is operated to move the flapper proximally.

In one embodiment, the distal sides of the valve pressing element, the leaflet capturing device, and the anchor delivery device are made of a shape memory alloy, preferably nitinol.

In one embodiment, the distal end of the guidewire is provided with a locking aperture through which the distal end of the guidewire is connected to the leaflet capturing platform when pre-assembled.

Compared with the prior art, the utility model has the advantages of:

1. different from the prior art, the utility model discloses a press the valve spare and cooperate with the leaflet catching device, the distal end portion of pressing the valve spare from the distal end side of leaflet catching platform when moving to the near-end side of leaflet catching platform, autologous leaflet forms the overlap region in the near-end side of leaflet catching platform, and repair system's simple structure, the pre-installation degree of difficulty is low, and whole operation flow is simple, has greatly simplified the flow of repairing the operation, has further reduced the required time of operation, is favorable to patient's postoperative rehabilitation;

2. different from the prior art, the utility model discloses utilize the valve leaf to press between valve leaf spare and the valve leaf trapping apparatus after forming the overlap region, the anchoring piece is fixed on the overlap region, can play the purpose of preventing the valve leaf prolapse, prevent the valve and flow backward, simultaneously, this scheme does not need to introduce other valve false bodies or helps the closure member in the repair system, and the implantation volume of implant is minimum, has reduced the internal stress of different spare parts when preassembling, has reduced the harm to the product, has reduced the complication;

3. different from the prior art, the utility model discloses a guide wire passes through behind the guiding hole to be fixed on valve leaflet catching platform, and after the valve leaflet formed the overlap region, the distal end of guide rail can reach the overlap region of valve leaflet along the guide wire through the guiding hole, and then anchors to the overlap region of valve leaflet, has avoided looking for the anchor point again in the operation, has not only guaranteed the accuracy of anchoring process, has also reduced the operation flow and the time of operation moreover;

4. be different from prior art, the utility model discloses the distal end portion that is provided with auxiliary stay and presss from both sides the closing member is connected, when carrying out the leaflet catching operation, can enlarge the radial area of leaflet catching platform, stability and success rate when improving the leaflet and catching.

Drawings

Fig. 1a to 1d are schematic views showing the rupture of the three chordae tendineae of the anterior mitral valve, which is susceptible to regurgitation upon contraction of the left ventricle, wherein fig. 1c and 1d are top views of fig. 1a and 1b, respectively.

Fig. 2 a-2 f are schematic diagrams illustrating the process of releasing the outer sheath of the repair system after moving towards the proximal end, wherein fig. 2e and 2f are schematic diagrams illustrating the structure of the leaflet capturing device of the present invention.

Fig. 3a to 3d are schematic views illustrating the process of the valve pressing member clamping the valve leaflet according to the present invention, wherein fig. 3b is a top view of fig. 3 a.

Fig. 4 a-4 e are schematic views illustrating the fixing process of the anchor delivery device of the present invention, wherein fig. 4e is an embodiment of the anchor.

Fig. 5 a-5 h are schematic views of the anchoring device anchoring the valve leaflet according to the present invention.

Fig. 6a to 6c are schematic views of the evacuation process of the repairing system of the present invention.

Fig. 7 a-7 b illustrate another embodiment of the anchor of the present invention secured within the heart.

The names of the parts indicated by the numbers in the drawings are as follows: 1-outer sheath, 2-inner tube, 3-leaflet capturing device, 31-leaflet capturing platform, 311-auxiliary support device, 4-valvular pressing element, 5-anchoring element, 6-anchoring element delivery device, 61-guiding rail, 611-guiding hole, 62-puncture rail, 63-bending structure, 7-pushing element, 8-guiding line, 9-overlapping area.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples.

The near end of the utility model is the end close to the operator, and the far end is the end far away from the operator.

The first embodiment is as follows:

chordae tendineae are the fibrous collagen tissue in the form of a cord connecting the leaflets to the papillary muscles, starting at the apex of the papillary muscles, attached to the rough portions of the anterior and posterior leaflets (as shown in fig. 1a and 1 c), wherein the chordae tendineae attached to the free edges of the leaflets primarily function to prevent the leaflets from inverting towards the atrium upon ventricular systole, wherein rupture of any one chordae tendineae can cause some degree of mitral regurgitation, and when the tertiary chordae tendineae rupture (as shown in fig. 1b and 1 d), mitral regurgitation occurs upon ventricular systole, affecting the normal flow of cardiac blood flow.

When used for treatment of mitral valve disease, a repair system for preventing valve regurgitation, as shown in fig. 2 a-2 d, comprises a control handle (not shown) and a delivery catheter (not shown), wherein the delivery catheter (not shown) comprises a leaflet capturing device 3 and a pressing member 4, the distal end of the leaflet capturing device 3 is provided with a leaflet capturing platform 31, the distal end portion of the pressing member 4 is arranged at the distal side of the leaflet capturing platform 31, and when a native leaflet is positioned between the leaflet capturing platform 31 and the distal end portion of the pressing member 4, the distal end portion of the pressing member 4 moves from the distal side of the leaflet capturing platform 31 to the proximal side of the leaflet capturing platform 31, the native leaflet forms an overlapping region 9 at the proximal side of the leaflet capturing platform 31; through the cooperation of the pressing flap component 4 and the leaflet catching device 3, the leaflets are pressed between the pressing flap component 4 and the leaflet catching platform 31, when the pressing flap component 4 moves to the proximal side of the leaflet catching device 3 continuously, the leaflets form an overlapping area 9 between the pressing flap component 4 and the leaflet catching device 3, and the folding mode of the leaflets is simple and effective and has low requirements on operators.

The components and connection of the components of the repair system for preventing valve regurgitation according to the present invention will be described in detail with reference to the accompanying drawings;

in this embodiment, an anchoring element 5 and an anchoring element delivery device 6 are further disposed in the delivery catheter (not shown), when the valve leaflets form an overlapping region 9 between the valve pressing member 4 and the valve leaflet capturing device 3, the control handle (not shown) is operated to make the distal end of the anchoring element delivery device 6 abut against the overlapping region 9, and the anchoring element 5 is moved distally by the anchoring element delivery device 6 and penetrates through the overlapping region 9 and is connected thereto, as shown in fig. 5a to 5 h.

In this embodiment, the overlapping area 9 is in a triangular structure, as shown in fig. 3 d; the overlapping area 9 of the triangular structure is more stable in the mechanical structure, so that the anchoring is more stable, the repairing effect is ensured for a long time, and the backflow is avoided.

In this embodiment, the anchor delivery device 6 includes a guide track 61, a piercing track 62 disposed within the guide track 61, the anchor 5 and the pusher 7 are disposed within the piercing track 62 when pre-assembled, the distal end of the piercing track 62 is sharp, the distal end of the piercing track 62 pierces and then passes through the overlapping region 9, the anchor 5 is pushed out of the piercing track 62 by the pusher, and the anchor 5 passes through the overlapping region 9 and then is retained in a knotted manner at one side of the overlapping region 9.

In this embodiment, the anchor 5 may be a wire, as shown in fig. 4 e; adopt the mode of knot to carry on spacingly to overlap area 9 for whole repair operation's implant is few, effectively avoids the destruction to patient's intracardiac protogenesis tissue, and simultaneously, few implant also can make the patient resume as soon as possible after the operation, has very strong clinical meaning.

In this embodiment, the anchor delivery device 6 further includes a guide wire 8, the guide rail 61 is provided with guide holes 611 at both sides of the distal end thereof, the guide holes 611 and the guide rail 61 are fixedly connected (as shown in fig. 4b and 4 c), when the device is pre-assembled, one end of the guide wire 8 is connected to a control handle (not shown), the other end of the guide wire 8 passes through the guide holes 611 and is connected to the leaflet catching platform 31, when the control handle (not shown) is operated to tighten and lock the guide wire 8, the connection among the leaflet catching platform 31, the guide rail 61 and the guide wire 8 is formed so that the relative positions therebetween are fixed, thereby ensuring the accurate positioning of the anchor 5 and avoiding the need to spend a lot of time searching for an anchor point during the operation.

In this embodiment, the distal end of the guide rail 61 and the distal end of the puncture rail 62 are both provided with a bending adjusting structure 63, as shown in fig. 2a, a slit tube made of a catheter-grade nickel-titanium tube with relatively good elasticity has certain strength and can be partially bent, the distal end side of the anchor delivery device 6 has a preset shape, and when the valve pressing element 4 and the valve leaflet capturing platform 31 are operated to form the overlapping region 9 of the valve leaflets, the guide wire 8 is tensioned, so that the distal end portion of the anchor delivery device 6 can be guided to the overlapping region 9 of the valve leaflets, so that the anchor point does not need to be searched again in the surgical process, thereby saving the surgical time and improving the success rate of the surgical operation.

In this embodiment, the guide wire 8 is a flexible wire, is made of a polymer material or a metal wire, has certain strength and toughness, is high in mobility, has high strength during tensioning connection, does not affect other components during loosening, and reduces loading difficulty.

In this embodiment, the capturing platform 31 further includes an auxiliary supporting device 311, as shown in fig. 2f, the auxiliary supporting device 311 is connected to the leaflet capturing platform 31, and the auxiliary supporting device 311 can expand the radial area of the leaflet capturing platform 31, thereby improving the stability and success rate of leaflet capturing.

In the present embodiment, the valve pressing member 4 has a preset configuration, the distal end portion of the valve pressing member 4 is bent, and the control handle is operated to move the valve pressing member 4 proximally, so that the native valve leaflets form an overlapping region 9 on the proximal side of the leaflet catching platform 31.

In this embodiment, the distal sides of the crimping element 4, the leaflet capturing device 3 and the anchor delivery device 6 are made of a shape memory alloy, preferably nitinol.

In this embodiment, the guide hole 611 and the guide rail 61 are integrally formed, as shown in fig. 4 c.

In this embodiment, the anchoring element 5 is loaded proximally into the pusher 7, as shown in fig. 5d, which is advantageous in that: the pusher 7 can push the anchor 5 distally in the piercing rail 62.

The utility model discloses an operation flow and principle do:

1. the leaflet capturing platform 31, the crimping element 4, the anchor delivery device 6 are crimped in the outer sheath 1, the anchor 5 is pre-loaded into the puncture rail 62;

2. the repair system for preventing the valve regurgitation is delivered from the ventricle to the valve annulus position through the apical approach, the control handle is operated to withdraw the outer sheath 1, the guide rail 61, the leaflet capturing platform 31 and the valve pressing member 4 are released, and in the process, the leaflet capturing platform 31 and the valve pressing member 4 are restored to the preset shapes as shown in fig. 2a to 2 d;

3. operating the control handle so that the valve leaflet is positioned between the valve leaflet capturing device 3 and the valve leaflet capturing device 4, the valve leaflet capturing device 4 moving proximally and pressing the valve leaflet between the valve leaflet capturing device 4 and the valve leaflet capturing platform 31, when the distal end portion of the valve leaflet capturing device 4 moves to the proximal side of the valve leaflet capturing device 3, the valve leaflet forms an overlapping region 9 between the valve leaflet capturing device 3 and the valve leaflet capturing device 4, as shown in fig. 3 a-3 d, when the distal end of the anchor delivery device 6 is tightly attached to the overlapping region 9, as shown in fig. 4 a;

4. tensioning the guide wire 8 so that the distal end of the guide rail 61 is perpendicular to the overlap region 9 (as shown in fig. 4 b-4 d), operating the control handle to cause the distal end of the puncture rail 62 to puncture and then penetrate the overlap region 9, pushing the anchor 5 out of the puncture rail 62 by the pusher 7, and after releasing the anchor 5, knotting the left portion of the overlap region 9, as shown in fig. 5 a-5 e, wherein the anchor 5 is a wire;

5. operating the control handle to retract the piercing guide 62 to the right of the overlap region 9, releasing the anchor 5 and tying a knot in the right of the overlap region 9, and operating the control handle to shear the anchor 5, as shown in fig. 5 f-5 h;

6. after anchoring is completed, the control handle is operated to separate the valve pressing element 4 from the valve leaflets, the control handle is operated to recover the valve leaflet catching platform 31, the valve pressing element 4 and the anchor delivery device 6 into the delivery tube, and the control handle is operated continuously to move the outer sheath 1 towards the near end until the heart is completely withdrawn, as shown in fig. 6a to 6 c.

The second embodiment is as follows:

a repair system for preventing valve regurgitation comprises a control handle and a delivery catheter, wherein the delivery catheter comprises an outer sheath 1, an inner tube 2 arranged in the outer sheath 1, a valve leaf catching device 3 and a valve pressing piece 4, the distal end of the leaflet catching device 3 is provided with a leaflet catching platform 31, the distal end portion of the crimping member 4 is provided on the distal side of the leaflet catching platform 31, the distal end portion of the valve pressing member 4 is movable from the distal side of the leaflet catching platform 31 to the proximal side of the leaflet catching platform 31, when a leaflet is positioned between the leaflet capturing device 3 and the leaflet pressing member 4, the leaflet pressing member 4 moves proximally and presses the leaflet between the leaflet pressing member 4 and the leaflet capturing platform 31, when the distal end portion of the pressing flap member 4 is moved to the proximal side of the leaflet catching device 3, the leaflets form an overlapping region 9 between the pressing flap member 4 and the leaflet catching device 3; tensioning the guide wire 8 so that the distal most end of the guide rail 61 is perpendicular to the overlap region 9, operating the control handle so that the distal end of the puncture rail 62 pierces and then passes through the overlap region 9, pushing the anchor 5 out of the puncture rail 62 by the pusher 7, tying a knot in the left part of the overlap region 9 after release of the anchor 5, continuing to operate the control handle so that the puncture rail 62 is retracted to the right part of the overlap region 9, tying a knot in the right part of the overlap region 9 after release of the anchor 5, and then completing the anchoring of the leaflets by the anchor 5.

The difference from the specific embodiment is that: as shown in fig. 7a and 7b, after the anchoring of the free edge of the valve leaflet of the anchoring element 5 is completed, one end of the anchoring element 5 is fixed on the valve leaflet, and the other end of the anchoring element 5 is still in the puncture guide rail 62; the control handle is operated to move the anchor delivery device 6 towards the proximal end, the distal end of the guide rail 61 is moved towards the apex of the left ventricle, when the other end of the anchor 5 moves to the apex, the control handle is operated to fix the other end of the anchor 5 at the apex of the heart by the anchor delivery device 6, and the control handle is operated to separate the anchor 5 from the puncture rail 62 to fix the other end of the anchor 5 at the apex of the heart, so that the design aims to: one end of the anchor 5 and the other end of the anchor 5 are fixed to the valve leaflet and the apex of the heart respectively, and the anchor 5 is similar to a chordae tendineae and can effectively pull the free edge of the valve leaflet to prevent the valve leaflet from turning towards the atrium when the ventricle contracts.

The above description is only for the preferred embodiment of the present invention, and for those skilled in the art, there are variations on the detailed description and the application scope according to the idea of the present invention, and the content of the description should not be construed as a limitation to the present invention.

Claims

1. A repair system for preventing valve regurgitation comprising a control handle and a delivery catheter characterized by: the delivery catheter includes a leaflet capturing device having a distal end provided with a leaflet capturing platform and a pressing member having a distal end portion disposed on a distal side of the leaflet capturing platform, the native leaflet forming an overlapping region on a proximal side of the leaflet capturing platform when the native leaflet is positioned between the leaflet capturing platform and the distal end portion of the pressing member is moved from the distal side of the leaflet capturing platform to the proximal side of the leaflet capturing platform.

2. A repair system for preventing valve regurgitation according to claim 1 wherein: the delivery catheter is also internally provided with an anchoring element and an anchoring element delivery device, when the autologous valve leaflets form an overlapping region at the proximal side of the valve leaflet catching platform, the control handle is operated to ensure that the distal end of the anchoring element delivery device is abutted against the overlapping region, and the anchoring element penetrates through the overlapping region and is connected with the overlapping region.

3. A repair system for preventing valve regurgitation according to claim 1 wherein: the overlapping area is in a triangular structure.

4. A repair system for preventing valve regurgitation according to claim 2 wherein: the anchor delivery device includes a guide track, a piercing track disposed within the guide track, a pusher disposed within the piercing track, and an anchor disposed on a distal side of the pusher.

5. A repair system for preventing valve regurgitation according to claim 4 wherein: the anchor delivery device further comprises a guide wire, the far end of the guide rail is provided with a guide hole, one end of the guide wire is connected with the control handle, and the other end of the guide wire penetrates through the guide hole to be connected with the valve leaflet catching platform.

6. A repair system for preventing valve regurgitation according to claim 1 wherein: the capture platform further comprises an auxiliary support device connected with the leaflet capture platform.

7. A repair system for preventing valve regurgitation according to claim 1 wherein: the leaflet capturing device is an integral closed loop structure, and the distal end portion of the leaflet capturing device is bent to form the leaflet capturing platform.

8. A repair system for preventing valve regurgitation according to claim 4 wherein: the distal end part of the guide rail and the distal end part of the puncture guide rail are both provided with bend adjusting structures.

9. A repair system for preventing valve regurgitation according to claim 2 wherein: the anchor may be a wire or an anchor needle.

10. A repair system for preventing valve regurgitation according to claim 4 wherein: the far end of the puncture guide rail is a sharp part.