A repair system for preventing valvular regurgitation

Abstract

The present invention relates to the field of medical devices, and particularly to a repair system for preventing valvular regurgitation, which includes a control handle and a delivery catheter. The delivery catheter includes a leaflet capture device and a leaflet pressing member. A leaflet capture platform is provided at the distal end of the leaflet capture device. The distal portion of the leaflet pressing member is disposed on the distal side of the leaflet capture platform. When the autologous leaflet is located between the leaflet capture platform and the distal portion of the leaflet pressing member, and the distal portion of the leaflet pressing member moves from the distal side of the leaflet capture platform to the proximal side of the leaflet capture platform, an overlapping area of the autologous leaflet is formed on the proximal side of the leaflet capture platform. The structure of the present invention is simple, the preloading difficulty is low, and the entire operation process is simple, greatly simplifying the repair surgery process, further reducing the time required for the surgery, and being beneficial to the postoperative rehabilitation of the patient.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a repair system for preventing valvular regurgitation. Background Art

[0002] The mitral valve is located at the left atrioventricular orifice and consists of five parts: the annulus, leaflets, chordae tendineae, papillary muscles, and commissural junctions. Its accurate anatomical name is the mitral apparatus or mitral complex.

[0003] The tricuspid valve is located at the right atrioventricular orifice and has three approximately triangular sail-shaped valves. The base of the valve is attached to the fibrous ring of the atrioventricular orifice. Functionally, the fibrous ring, valve, chordae tendineae, and papillary muscles can be regarded as the tricuspid valvar complex.

[0004] Mitral regurgitation can be divided into the following two types: 1. Rheumatic mitral regurgitation, mainly caused by mitral insufficiency, can cause reverse blood flow, resulting in the mixing of different blood, and causing a decline in the heart's pumping and oxygen delivery functions. 2. Non-rheumatic mitral regurgitation usually refers to mitral regurgitation of varying degrees caused by abnormalities in the mitral valve itself and its surrounding anatomical structures other than rheumatic valvular lesions. There are many causes of non-rheumatic mitral insufficiency, and the more common ones are: mitral valve prolapse, papillary muscle dysfunction or chordae tendineae rupture, left atrial myxoma, valvular annulus calcification, congenital valvular malformations, infective endocarditis, etc. Mitral regurgitation can also be divided into functional, degenerative, or mixed types. The most common are degenerative and functional mitral regurgitation. Functional mitral regurgitation is generally secondary to impaired left ventricular wall motion function, left ventricular dilation, and papillary muscle dysfunction, and is generally seen in heart failure patients. This part of the patients also includes ischemic mitral regurgitation secondary to coronary heart disease and mitral regurgitation related to non-ischemic cardiomyopathy. Degenerative mitral regurgitation disease is generally considered to be a pathological change in the valve structure or a pathological change in the subvalvular structure, including abnormal extension or rupture of the chordae tendineae.

[0005] Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular dilation, and tricuspid annulus dilation. After tricuspid regurgitation occurs, right heart failure symptoms such as fatigue, ascites, edema, liver area pain, indigestion, and poor appetite are aggravated. Tricuspid insufficiency is mainly divided into functional tricuspid insufficiency and organic tricuspid insufficiency. Organic insufficiency of the valve caused by rheumatic fever is very few, and most are functional insufficiency. The most common cause is right ventricular dilation caused by pulmonary hypertension, tricuspid annulus dilation, resulting in relative tricuspid insufficiency while the valve structure itself is normal. Such as rheumatic mitral disease, congenital cardiovascular disease, pulmonary heart disease, etc.

[0006] Traditional treatment methods for mitral and tricuspid valve regurgitation include medical treatment applicable to mild to severe regurgitation and surgical methods with corresponding surgical indications. Among them, surgical methods also include mitral and tricuspid valve replacement and mitral and tricuspid valve repair. For isolated mitral regurgitation, only 30% of patients require mitral valve replacement, and the remaining only need mitral valve repair. In surgical methods, typical open-chest and open-heart surgeries are overly invasive, requiring cardiopulmonary bypass, with a relatively high incidence of complications and infection risk. In order to reduce the surgical risk, transcatheter interventional replacement and repair surgical methods have been developed.

[0007] According to the literature [Enriquez-Sarano M, Schaff HV, Orszulak TA, et al. Valve repair improves the outcome of surgery for mitral regurgitation: a multivariate analysis [J]. Circulation, 1995, 91(4): 1022-1088], it can be seen that replacement surgery has a relatively high overall surgical mortality rate and a relatively low survival rate. For transcatheter treatment of valve regurgitation, the following are the problems that need to be solved urgently: reducing the implant volume of implants as much as possible while ensuring the anti-regurgitation effect; the anti-regurgitation device must be accurately positioned and firmly fixed at the site to be treated; the anti-regurgitation device needs to minimally affect the movement of the remaining normally functioning valve leaflets; the anti-regurgitation device needs to adapt to the physiological structural differences of the valve annulus. The technical points of different anti-regurgitation devices in the current existing technologies are listed below.

[0008] In Patent CN103338726A, a method for treating the improper engagement of a patient's heart valve is described. The method includes introducing the implant into the heart when the implant is in a first configuration, expanding the implant from the first configuration to a second configuration within the heart. The implant in the second configuration has engagement aids with first and second opposite engagement surfaces, and supporting the expanded implant such that the engagement aids are offset from the axis of the heart valve along the engagement zone. In its claims, the method further includes selectively disposing a first anchor at a first target location near the first commissure (the first commissure being the first connection of the first and second leaflets of the heart valve), selectively disposing a second anchor at a second target location near the second commissure (the second commissure being the second connection of the first and second leaflets of the heart valve), introducing the engagement aids into the heart. In another claim, it is described that the implant includes engagement aids, a first anchor, and a second anchor. The engagement aids have an axis and first and second opposite main engagement surfaces, each engagement surface extending transversely between a first lateral edge and a second lateral edge of the engagement aids. The first anchor can be selectively disposed at a first target location in the heart near the first commissure such that the first lateral edge is oriented towards the first commissure. Subsequently, the anchoring position of the second anchor is also defined near the second commissure. In another claim, it is particularly defined that the axis of the implant needs to extend along the valve axis, and the first and second sides of the engagement aids need to extend along the curve of the engagement zone of the heart valve. The engagement aids of the supported implant are sufficiently transversely conformable such that the engagement between the implant and the heart causes the engagement aids between the edges to bend transversely towards the curve defined by the engagement zone of the heart valve. The above claims define that the anchoring positions need to be near the first and second commissures, and also define that the entire engagement aids need to be sufficiently transversely conformable with the heart valve.This kind of technology cannot adapt to some cases of valve prolapse. While achieving the effect of preventing regurgitation, it has the following disadvantages. First, "supporting the deployed implant such that the engagement assist moves along the engagement zone away from the axis of the heart valve" described in this invention means that when the implant is naturally deployed, the engagement assist shrinks along the center line, which requires the engagement assist to be formed into a cone shape. Second, the engagement assist covers the normal non-prolapsed valve, and during long-term movement, it is prone to adhesion, sacrificing the normal functional operation of part of the normal valve. Third, for the native valve towards the ventricular direction near the native annulus, during the opening and closing process, the movement amplitude is smaller than that of the leaflet near the valve tip, and it is prone to adhesion with the cardiac valve assist that is fully laterally conformable and adheres to it. This is different from the upper engagement assist at the annulus. During long-term implantation, the annulus should grow together with the native annulus to increase the fixation effect. However, for the native valve towards the ventricular direction near the native annulus, once adhesion occurs, it will affect the movement effect of the leaflet and is prone to secondary regurgitation, resulting in the failure of the anti-regurgitation treatment. Fourth, due to the different sizes of each person's native annulus, there are many product specifications in this technology.

[0009] Patent US20130325110A1 describes a method for treating mitral and tricuspid regurgitation by delivering a prosthetic valve leaflet closing assist without stopping the heart. The method includes using a flexible track to deliver a ventricular fixator from the atrium through the native valve into the right ventricle for anchoring, using a catheter to deliver and adjust the position of the prosthesis at the tricuspid annulus until the regurgitation is reduced, relatively fixing the catheter to the flexible track, and fixing it on the inferior vena cava. Although this delivery method can adjust the position of the prosthesis to adapt to different regurgitation positions and has a certain adaptability to lesions, the fixed position on the inferior vena cava is far from the annulus position, which is prone to insecure fixation and displacement of the prosthesis after fixation.

[0010] The present invention adopts a repair system for preventing valve regurgitation, which has a simple structure and is convenient to operate. It can cope with various lesions of different degrees and positions and can be used to treat mitral valve leaflet prolapse. Summary of the Invention

[0011] The object of the present invention is to overcome the defects of the prior art and provide a repair system for preventing valvular regurgitation for patients with mitral valve leaflet prolapse who require interventional treatment. Although the repair systems for preventing valvular regurgitation in the prior art have achieved certain effects in preventing regurgitation, the structure of the repair system is relatively complex, unable to adapt to the physiological structure of the valve leaflets, and the anchoring part of the anchor in the tough tissue part in the heart is not firm and is prone to slipping. The implant of the repair system for preventing valvular regurgitation of the present invention has a small implant amount, the anchoring unit is accurately positioned, firmly anchored, the delivery catheter has a small diameter, is easy to operate, the anchoring device and the delivery device cooperate well, is safe and reliable, can cope with various lesions of different degrees and positions, and can be used for treating mitral valve leaflet prolapse.

[0012] To solve the above technical problems, the present invention is solved by the following technical solutions:

[0013] A repair system for preventing valvular regurgitation, comprising a control handle and a delivery catheter. The delivery catheter includes a leaflet capture device and a leaflet pressing member. The distal end of the leaflet capture device is provided with a leaflet capture platform. The distal part of the leaflet pressing member is arranged on the distal side of the leaflet capture platform. When the autologous valve leaflet is located between the leaflet capture platform and the distal part of the leaflet pressing member, when the distal part of the leaflet pressing member moves from the distal side of the leaflet capture platform to the proximal side of the leaflet capture platform, an overlapping area is formed on the proximal side of the leaflet capture platform by the autologous valve leaflet.

[0014] The present invention can also be further realized by the following technical solutions:

[0015] In one embodiment, an anchor and an anchor delivery device are further arranged in the delivery catheter. When an overlapping area is formed by the valve leaflet between the leaflet pressing member and the leaflet capture device, the control handle is operated so that the distal end of the anchor delivery device abuts against the overlapping area, and the anchor moves distally through the anchor delivery device and penetrates and connects with the overlapping area.

[0016] In one embodiment, the overlapping area has a triangular structure.

[0017] In one embodiment, the anchor delivery device includes a guiding rail and a puncture guiding rail arranged in the guiding rail. During preloading, the anchor and the pushing member are arranged in the puncture guiding rail. The distal end of the puncture guiding rail is a sharp part. The distal end of the puncture guiding rail pierces and then passes through the overlapping area, and the anchor is pushed out by the pushing member.

[0018] In one embodiment, the anchor delivery device further includes a guide wire. Guide holes are provided on both sides of the distal end of the guide rail. The guide holes are fixedly connected to the guide rail. During pre-installation, one end of the guide wire is connected to the control handle, and the other end of the guide wire passes through the guide holes and is connected to the leaflet capture platform. When the control handle is operated to tighten and lock the guide wire, a connection is formed among the leaflet capture platform, the guide rail, and the guide wire, so that their relative positions are fixed, ensuring accurate positioning of the anchor and avoiding the need to spend a lot of time searching for the anchor point during the operation. The puncture guide rail, after the anchor passes through the overlapping area, is limited at one side of the overlapping area in a knotting manner.

[0019] In one embodiment, bending structures are provided at the most distal ends of both the guide rail and the puncture guide rail. The bending structures are made of catheter-grade nitinol tubes with relatively good elasticity, which are slit tubes with a certain strength and can be partially bent. The distal side of the anchor delivery device has a preset shape. When the leaflet pressing member and the leaflet capture platform are operated to form an overlapping area of the leaflets, the guide wire is tightened, so that the distal part of the anchor delivery device can be guided to the overlapping area of the leaflets, eliminating the need to re-search for the anchor point during the operation, saving the operation time and improving the success rate of the operation.

[0020] In one embodiment, the guide wire is a flexible wire, made of a polymer material or a metal wire, having a certain strength and toughness, large mobility, large strength when tightened and connected, and will not affect other components when loosened, reducing the loading difficulty.

[0021] In one embodiment, the anchor can be a wire.

[0022] In another embodiment, the anchor can be an anchor needle.

[0023] In one embodiment, the capture platform further includes an auxiliary support device, which is connected to the leaflet capture platform. The auxiliary support device can expand the radial area of the leaflet capture platform, improving the stability and success rate during leaflet capture.

[0024] In one embodiment, the leaflet capture device is an integral closed-loop structure, and the distal part of the leaflet capture device is bent to form the leaflet capture platform.

[0025] In one embodiment, the leaflet pressing member has a preset shape, and the distal part of the leaflet pressing member is bent. The control handle is operated to move the leaflet pressing member proximally.

[0026] In one embodiment, the distal sides of the valve pressing member, the leaflet capturing device, and the anchoring member delivery device are made of shape memory alloy, preferably nitinol alloy.

[0027] In one embodiment, a locking hole is provided at the distal end of the guide wire. During preloading, the distal end of the guide wire is connected to the leaflet capturing platform through the locking hole.

[0028] Compared with the prior art, the advantages of the present invention are as follows:

[0029] 1. Different from the prior art, in the present invention, the valve pressing member cooperates with the leaflet capturing device. When the distal part of the valve pressing member moves from the distal side to the proximal side of the leaflet capturing platform, the autologous leaflets form an overlapping area on the proximal side of the leaflet capturing platform. The structure of the repair system is simple, the preloading difficulty is low, and the whole operation process is simple, greatly simplifying the repair surgery process, further reducing the time required for the surgery, and being beneficial to the postoperative rehabilitation of the patient;

[0030] 2. Different from the prior art, after the leaflets form an overlapping area between the valve pressing member and the leaflet capturing device, the anchoring member is fixed on the overlapping area, which can prevent leaflet prolapse and block valve regurgitation. At the same time, this solution does not require introducing other valve prostheses or coaptation aids into the repair system, the implant amount of the implant is extremely small, the internal stress of different components during preloading is reduced, the damage to the product is reduced, and complications are reduced;

[0031] 3. Different from the prior art, the guide wire of the present invention is fixed on the leaflet capturing platform after passing through the guiding hole. When the leaflets form an overlapping area, the distal end of the guiding rail can reach the overlapping area of the leaflets along the guide wire through the guiding hole, thereby anchoring the overlapping area of the leaflets, avoiding re-searching for the anchoring point during the surgery, not only ensuring the accuracy of the anchoring process, but also reducing the operation process and time of the surgery;

[0032] 4. Different from the prior art, the present invention is provided with an auxiliary support device connected to the distal part of the clamping member. When performing the leaflet capturing operation, the radial area of the leaflet capturing platform can be expanded, improving the stability and success rate during leaflet capturing. Description of the Drawings

[0033] Figures 1a to 1d It is a schematic diagram of the rupture of the tertiary chordae tendineae of the anterior mitral valve. At this time, valve regurgitation is likely to occur during left ventricular contraction, where Figure 1c and Figure 1d are respectively Figure 1a and Figure 1b top views.

[0034] Figures 2a to 2fSchematic diagram of the release process after the outer sheath of the repair system of the present invention moves proximally, where Figure 2e and 2f are schematic structural diagrams of the leaflet capture device of the present invention.

[0035] Figures 3a to 3d Schematic diagram of the process of the leaflet pressing member clamping the leaflet of the present invention, where Figure 3b is Figure 3a top view.

[0036] Figures 4a to 4e Schematic diagram of the fixing process of the anchoring member conveying device of the present invention, where Figure 4e is an implementation manner of the anchoring member.

[0037] Figures 5a to 5h Schematic diagram of the process of the anchoring member of the present invention anchoring the leaflet.

[0038] Figures 6a to 6c Schematic diagram of the withdrawal process of the repair system of the present invention.

[0039] Figures 7a to 7b Another implementation manner of the in - heart fixation of the anchoring member of the present invention.

[0040] The names of the parts referred to by each number in the drawings are as follows: 1 - outer sheath, 2 - inner tube, 3 - leaflet capture device, 31 - leaflet capture platform, 311 - auxiliary support device, 4 - leaflet pressing member, 5 - anchoring member, 6 - anchoring member conveying device, 61 - guiding rail, 611 - guiding hole, 62 - puncture rail, 63 - bending adjustment structure, 7 - pushing member, 8 - guiding wire, 9 - overlapping area. Detailed implementation manners

[0041] The present invention will be further described in detail below in conjunction with the drawings and embodiments.

[0042] In the present invention, the proximal end refers to the end close to the surgical operator, and the distal end refers to the end far from the surgical operator. Specific embodiment one:

[0044] Chordae tendineae are cord - like collagen fiber tissues connecting leaflets and papillary muscles. It starts from the top of the papillary muscle and attaches to the rough parts of the anterior and posterior leaflets (as shown in Figure 1a and 1c ). Among them, the chordae tendineae attached to the free edge of the leaflet mainly function to prevent the leaflet from flipping into the atrium during ventricular contraction. The rupture of any one chordae tendineae can cause a certain degree of mitral regurgitation. When the tertiary chordae tendineae rupture (as shown in Figure 1b and 1d ), mitral regurgitation will occur during ventricular contraction, affecting the normal flow of cardiac blood.

[0045] When used for the treatment of mitral valve diseases, a repair system for preventing valve regurgitation, such as Figures 2a to 2d shown, includes a control handle (not labeled) and a delivery catheter (not labeled). The delivery catheter (not labeled) includes a leaflet capture device 3 and a leaflet pressing member 4. The distal end of the leaflet capture device 3 is provided with a leaflet capture platform 31. The distal portion of the leaflet pressing member 4 is disposed on the distal side of the leaflet capture platform 31. When the autologous leaflet is located between the leaflet capture platform 31 and the distal portion of the leaflet pressing member 4, and the distal portion of the leaflet pressing member 4 moves from the distal side of the leaflet capture platform 31 to the proximal side of the leaflet capture platform 31, an overlapping region 9 is formed on the proximal side of the leaflet capture platform 31 by the autologous leaflet. By the cooperation of the leaflet pressing member 4 and the leaflet capture device 3, the leaflet is pressed between the leaflet pressing member 4 and the leaflet capture platform 31. When the leaflet pressing member 4 continues to move proximally to the proximal side of the leaflet capture device 3, an overlapping region 9 is formed between the leaflet pressing member 4 and the leaflet capture device 3. This way of folding the leaflet is simple and effective, and has relatively low requirements for the operator.

[0046] Next, the composition and connection manner of each component of the repair system for preventing valve regurgitation of the present invention will be described in detail with reference to the accompanying drawings;

[0047] In this embodiment, an anchor 5 and an anchor delivery device 6 are further provided in the delivery catheter (not labeled). When an overlapping region 9 is formed between the leaflet pressing member 4 and the leaflet capture device 3 by the leaflet, the control handle (not labeled) is operated to make the distal end of the anchor delivery device 6 abut against the overlapping region 9. The anchor 5 moves distally through the anchor delivery device 6 and penetrates and connects with the overlapping region 9, as Figures 5a to 5h shown.

[0048] In this embodiment, the overlapping region 9 has a triangular structure, as Figure 3d shown; the overlapping region 9 with a triangular structure is also more stable in mechanical structure, making its anchoring more stable, ensuring the repair effect in the long term, and avoiding regurgitation.

[0049] In this embodiment, the anchor delivery device 6 includes a guide rail 61 and a puncture guide rail 62 disposed in the guide rail 61. During preloading, the anchor 5 and a pusher 7 are disposed in the puncture guide rail 62. The distal end of the puncture guide rail 62 is a sharp portion. The distal end of the puncture guide rail 62 pierces and then passes through the overlapping region 9. The anchor 5 is pushed out of the puncture guide rail 62 by the pusher, and the anchor 5 is limited in a knotting manner on one side of the overlapping region 9 after passing through the overlapping region 9.

[0050] In this embodiment, the anchor 5 can be a wire, as Figure 4eAs shown; the overlapping area 9 is limited by means of a knot, so that the implants in the whole repair operation are extremely few, effectively avoiding the damage to the native tissues in the patient's heart. At the same time, the extremely few implants can also enable the patient to recover as soon as possible after the operation, which has strong clinical significance.

[0051] In this embodiment, the anchor delivery device 6 further includes a guide wire 8. Guide holes 611 are provided on both sides of the distal end of the guide rail 61, and the guide holes 611 are fixedly connected to the guide rail 61 (such as Figure 4b and 4c shown). During preloading, one end of the guide wire 8 is connected to a control handle (not marked), and the other end of the guide wire 8 passes through the guide hole 611 and is connected to the leaflet capture platform 31. When the control handle (not marked) is operated to tighten and lock the guide wire 8, a connection is formed between the leaflet capture platform 31, the guide rail 61 and the guide wire 8, so that their relative positions are fixed, thereby ensuring accurate positioning of the anchor 5 and avoiding spending a lot of time looking for an anchor point during the operation.

[0052] In this embodiment, bending adjustment structures 63 are provided at the outermost distal ends of both the guide rail 61 and the puncture guide rail 62, such as Figure 2a shown. It is made of a catheter-grade nitinol tube with relatively good elasticity and is a slotted tube with a certain strength and can be partially bent. The distal side of the anchor delivery device 6 has a preset shape. When the leaflet pressing member 4 and the leaflet capture platform 31 are operated to form an overlapping area 9 of the leaflets, the guide wire 8 is tightened, so that the distal part of the anchor delivery device 6 can be guided to the overlapping area 9 of the leaflets, eliminating the need to re-locate the anchor point during the operation, saving operation time and increasing the success rate of the operation.

[0053] In this embodiment, the guide wire 8 is a flexible wire, made of a polymer material or a metal wire, having a certain strength and toughness, large mobility, high strength when tightened and connected, and will not affect other components when loosened, reducing the loading difficulty.

[0054] In this embodiment, the capture platform 31 further includes an auxiliary support device 311, such as Figure 2f shown. The auxiliary support device 311 is connected to the leaflet capture platform 31. The auxiliary support device 311 can expand the radial area of the leaflet capture platform 31, improving the stability and success rate during leaflet capture.

[0055] In this embodiment, the leaflet pressing member 4 has a preset shape, and the distal part of the leaflet pressing member 4 is bent. The control handle is operated to move the leaflet pressing member 4 proximally, so that the autologous leaflets form an overlapping area 9 on the proximal side of the leaflet capture platform 31.

[0056] In this embodiment, the distal sides of the valve pressing member 4, the leaflet capturing device 3, and the anchoring member delivery device 6 are made of shape memory alloy, preferably nitinol alloy.

[0057] In this embodiment, the guiding hole 611 and the guiding rail 61 are integrally formed structures, as Figure 4c shown.

[0058] In this embodiment, the proximal end of the anchoring member 5 is loaded in the pusher member 7, as Figure 5d shown. The advantage of this design is that the pusher member 7 can push the anchoring member 5 distally in the puncture guiding rail 62.

[0059] The operation process and principle of the present invention are as follows:

[0060] 1. The leaflet capturing platform 31, the valve pressing member 4, and the anchoring member delivery device 6 are compressed and held in the outer sheath 1, and the anchoring member 5 is pre-loaded into the puncture guiding rail 62;

[0061] 2. The repair system for preventing valve regurgitation enters through the apical approach and is sent from the ventricle to the annulus position. The operating control handle retracts the outer sheath 1 to release the guiding rail 61, the leaflet capturing platform 31, and the valve pressing member 4. During this process, the leaflet capturing platform 31 and the valve pressing member 4 return to the preset shape, as Figures 2a to 2d shown;

[0062] 3. The operating control handle positions the leaflet between the leaflet capturing device 3 and the valve pressing member 4. The valve pressing member 4 moves proximally and presses the leaflet between the valve pressing member 4 and the leaflet capturing platform 31. When the distal part of the valve pressing member 4 moves to the proximal side of the leaflet capturing device 3, an overlapping area 9 is formed between the valve pressing member 4 and the leaflet capturing device 3, as Figures 3a to 3d shown. At this time, the distal end of the anchoring member delivery device 6 is in close contact with the overlapping area 9, as Figure 4a shown;

[0063] 4. Tighten the guide wire 8 so that the distal most end of the guiding rail 61 is perpendicular to the overlapping area 9 (as Figures 4b to 4d shown). The operating control handle causes the distal end of the puncture guiding rail 62 to pierce and then pass through the overlapping area 9. The anchoring member 5 is pushed out of the puncture guiding rail 62 by the pusher member 7. After the anchoring member 5 is released, it knots at the left part of the overlapping area 9, as Figures 5a to 5e shown. The anchoring member 5 is a wire;

[0064] 5. Operate the control handle to retract the puncture guide rail 62 to the right part of the overlapping area 9. After the anchor 5 is released, tie a knot in the right part of the overlapping area 9. Operate the control handle to cut the anchor 5, as Figures 5f to 5h shown;

[0065] 6. After the anchoring is completed, operate the control handle to separate the valve leaflet pressing member 4 from the valve leaflet. Operate the control handle to retract the valve leaflet capture platform 31, the valve leaflet pressing member 4, and the anchor delivery device 6 into the delivery tube. Continue to operate the control handle to move the outer sheath 1 proximally until it is completely withdrawn from the heart, as Figures 6a to 6c shown. Specific Embodiment 2:

[0067] A repair system for preventing valve regurgitation, comprising a control handle and a delivery catheter. The delivery catheter includes an outer sheath 1, an inner tube 2, a valve leaflet capture device 3, and a valve leaflet pressing member 4 disposed within the outer sheath 1. The distal end of the valve leaflet capture device 3 is provided with a valve leaflet capture platform 31. The distal portion of the valve leaflet pressing member 4 is disposed on the distal side of the valve leaflet capture platform 31. The distal portion of the valve leaflet pressing member 4 can move from the distal side of the valve leaflet capture platform 31 to the proximal side of the valve leaflet capture platform 31. When the valve leaflet is located between the valve leaflet capture device 3 and the valve leaflet pressing member 4, the valve leaflet pressing member 4 moves proximally and presses the valve leaflet between the valve leaflet pressing member 4 and the valve leaflet capture platform 31. When the distal portion of the valve leaflet pressing member 4 moves to the proximal side of the valve leaflet capture device 3, an overlapping area 9 is formed between the valve leaflet pressing member 4 and the valve leaflet capture device 3; tighten the guide wire 8 so that the distalmost end of the guide rail 61 is perpendicular to the overlapping area 9. Operate the control handle to pierce and then pass through the overlapping area 9 with the distal end of the puncture guide rail 62. The anchor 5 is pushed out of the puncture guide rail 62 by the pusher 7. After the anchor 5 is released, tie a knot in the left part of the overlapping area 9. Continue to operate the control handle to retract the puncture guide rail 62 to the right part of the overlapping area 9. After the anchor 5 is released, tie a knot in the right part of the overlapping area 9. At this time, the anchoring of the valve leaflet by the anchor 5 is completed.

[0068] The difference from Specific Embodiment 1 is that: as Figure 7a and 7bAs shown, after the anchor 5 is anchored at the free edge of the valve leaflet, one end of the anchor 5 is fixed on the valve leaflet, and the other end of the anchor 5 remains within the puncture guide rail 62; the operation control handle is used to move the anchor delivery device 6 proximally, and the distal end of the guide rail 61 moves towards the apex of the left ventricle. When the other end of the anchor 5 moves to the apex, the operation control handle is used to fix the other end of the anchor 5 at the apex by the anchor delivery device 6. The operation control handle separates the anchor 5 from the puncture guide rail 62, so that the other end of the anchor 5 is fixed at the apex. The purpose of this design is that one end and the other end of the anchor 5 are respectively fixed on the valve leaflet and the apex. 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 flipping towards the atrium during ventricular contraction.

[0069] The above content is only a preferred embodiment of the present invention. For those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manner and application scope. The content of this specification should not be construed as a limitation to the present invention.

Claims

1. A repair system for preventing valvular regurgitation, comprising a control handle and a delivery catheter, characterized in that: The delivery catheter includes a leaflet capture device and a leaflet pressing member. A leaflet capture platform is provided at the distal end of the leaflet capture device. The distal portion of the leaflet pressing member is disposed on the distal side of the leaflet capture platform. The leaflet pressing member moves proximally and presses the leaflet between the distal portion of the leaflet pressing member and the leaflet capture platform. When the native leaflet is located between the leaflet capture platform and the distal portion of the leaflet pressing member, and when the distal portion of the leaflet pressing member continues to move proximally to the proximal side of the leaflet capture device, the native leaflet forms an overlapping region on the proximal side of the leaflet capture platform and between the distal portion of the leaflet pressing member and the leaflet capture device.

2. The repair system for preventing valvular regurgitation according to claim 1, wherein: An anchoring member and an anchoring member delivery device are further provided in the delivery catheter. When the native leaflet forms an overlapping region on the proximal side of the leaflet capture platform, the control handle is operated such that the distal end of the anchoring member delivery device abuts against the overlapping region, and the anchoring member penetrates and connects with the overlapping region.

3. The repair system for preventing valvular regurgitation according to claim 1, characterized in that: The overlapping region has a triangular structure.

4. A repair system for preventing valvular regurgitation according to claim 2, wherein: The anchoring member delivery device includes a guiding rail, a puncture guiding rail disposed in the guiding rail, a pushing member and an anchoring member disposed in the puncture guiding rail. The anchoring member is disposed on the distal side of the pushing member.

5. A repair system for preventing valvular regurgitation according to claim 4, characterized in that: The anchoring member delivery device further includes a guiding wire. A guiding hole is provided at the distal end of the guiding rail. One end of the guiding wire is connected to the control handle, and the other end of the guiding wire passes through the guiding hole and is connected to the leaflet capture platform.

6. A repair system for preventing valvular regurgitation according to claim 1, characterized in that: The capture platform further includes an auxiliary support device, and the auxiliary support device is connected to the leaflet capture platform.

7. A repair system for preventing valvular regurgitation according to claim 1, characterized in that: The leaflet capture device is an integrated closed-loop structure, and the distal portion of the leaflet capture device is bent to form the leaflet capture platform.

8. A repair system for preventing valvular regurgitation according to claim 4, characterized in that: The distal portions of the guiding rail and the puncture guiding rail are both provided with bending adjustment structures.

9. A repair system for preventing valvular regurgitation according to claim 2, wherein: The anchoring member is a wire or an anchoring needle.

10. A repair system for preventing valvular regurgitation according to claim 4, characterized in that: The distal end of the puncture guiding rail is a sharp portion.

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