CN108904100B

CN108904100B - Implanting instrument for preventing valve regurgitation and conveying system thereof

Info

Publication number: CN108904100B
Application number: CN201810647765.2A
Authority: CN
Inventors: 吕世文; 李毅斌; 陈志�; 曹鹏
Original assignee: Ningbo Jenscare Biotechnology Co Ltd
Current assignee: Jenscare Scientific Co Ltd
Priority date: 2018-06-22
Filing date: 2018-06-22
Publication date: 2021-01-19
Anticipated expiration: 2038-06-22
Also published as: CN108904100A

Abstract

The invention relates to an implantation instrument for preventing valve regurgitation and a delivery system thereof, the implantation instrument comprises a distraction mechanism, a core piece and a closure aid, the opening mechanism is connected with the core piece, the far end of the closing-assisting piece is connected with the opening mechanism, the closing-assisting piece is flexible, in a free state, the opening mechanism is partially or completely positioned in the atrium of the patient, or the opening mechanism is completely positioned in the atrioventricular valve ring of the patient, the closing-assistant part is positioned between the autologous valve leaflets of the patient, the proximal end of the closing-assistant part is provided with a limit piece, the distal end of the retaining member is connected to the closing-aid member, the proximal end of the retaining member is connected to the core member or fixed on the heart tissue of the patient, and when the native valve of the patient is closed, the closure member is capable of partially engaging the core, and the core is secured at least one end to the patient's heart tissue. The invention can realize accurate positioning, convenient operation and firm anchoring, has less long-term thrombosis, is not easy to adhere to the original tissue, and can deal with pathological changes of different degrees and positions.

Description

Implanting instrument for preventing valve regurgitation and conveying system thereof

The technical field is as follows:

the invention belongs to the field of medical equipment, and particularly relates to an implantation equipment for preventing valve regurgitation and a delivery system thereof.

Background art:

normal mitral valve closure function depends on the complete structure and normal function of the 5 parts of the leaflets, annulus, chordae tendineae, papillary muscles, left ventricle. Structural and functional abnormalities in any of these 5 segments can cause mitral insufficiency. Mild reflux, with only minor labored dyspnea in the patient. Severe reflux (e.g., rupture of papillary muscles) occurs quickly with acute left heart failure and even cardiogenic shock. Mitral insufficiency can be classified into the following two categories: 1. rheumatic mitral insufficiency of the heart, mainly caused by mitral insufficiency, can cause the reverse flow of blood, thus mixing different blood and causing the reduction of the blood pumping and oxygen delivery functions of the heart. 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 insufficiency can also be classified as functional, degenerative, or mixed. Most common are degenerative and functional mitral insufficiency. Functionality is typically secondary to impaired left ventricular wall motor function, left ventricular dilatation, papillary muscle dysfunction, commonly found in heart failure patients. This fraction also includes ischemic mitral insufficiency secondary to coronary heart disease and mitral insufficiency associated with non-ischemic cardiomyopathy. Degenerative mitral insufficiency 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 tricuspid valve is located at the right atrioventricular orifice and has three approximately triangular sail-like valves, the valve base is attached to the fibrous ring of the atrioventricular orifice, and the fibrous ring, the valve, the chordae tendinae, and the papillary muscles are functionally visible as a tricuspid valve complex. The regurgitation of the tricuspid valve is generally caused by pulmonary hypertension, right ventricular enlargement and expansion of the tricuspid valve annulus, and after the regurgitation of the tricuspid valve, the symptoms of the right heart failure such as hypodynamia, ascites, edema, pain in the liver area, dyspepsia, anorexia and the like are aggravated. Tricuspid insufficiency is largely classified into functional and organic tricuspid insufficiency. The valve insufficiency caused by rheumatic fever is very few in organic insufficiency and most in functional insufficiency, and the most common causes are right ventricle expansion caused by pulmonary hypertension and tricuspid annulus enlargement, which causes 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. Simple mitral insufficiency, only 30% of patients requiring mitral valve replacement, and the remainder requiring only 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.

Many technologies for repairing mitral valve and tricuspid valve through catheter intervention have emerged in the market today, and the following problems are now to be solved: the implantation amount of the implant is reduced on the premise of ensuring the reflux prevention effect as much as possible; the devices that block reflux must be accurately positioned and firmly secured at the site to be treated; instruments that block flow need to minimally affect the movement of the remaining leaflets with normal function; devices that resist regurgitation need to accommodate the variability of the anatomy of the annulus.

Patent CN200580038672.0 discloses a device and a method for treating heart valve regurgitation, the prosthesis comprising an anchoring ring expanding within the left atrium to anchor the prosthesis and a bag member fixed to the anchoring ring. The pocket member is positioned within the mitral valve, between the leaflets, such that the open end of the pocket member is positioned within the left ventricle. When the mitral valve is open, blood flows through the bag member, maintaining the bag member in a collapsed state. When the mitral valve closes, the back pressure of the blood pushes into the bag member, expanding the bag member to an expanded shape. The mitral valve leaflets contact the expanded pocket member, allowing the prosthesis to block at least a portion of the openings between the leaflets, thereby minimizing regurgitated blood flow into the left atrium. The main problem with this technique is that blood is trapped in the bag member, the blood vortex tends to form a thrombus, and once the thrombus falls, it may cause a stroke or other risk of vessel occlusion, which can be serious or even fatal. At the same time, the opening and closing movement of the bag member from collapse to expansion is more weakened after fibrosis in vivo, the weakened degree of movement in turn promotes more severe fibrosis, forming a vicious circle, with the ultimate result that the bag member sticks to itself causing the device to fail.

The current clinical results show that there is no ideal product for treating valve regurgitation. The main reason is that mitral valve annulus, tricuspid valve annulus and the like have special physiological structures, and complex physiological environments exist below the valve annulus, so that accurate positioning and fixing of products are very difficult. In addition, the degree and the position of the valve prolapse lesion are different, for example, partial patients are incomplete in closure caused by anterior valve prolapse, partial patients are incomplete in closure caused by combined valve lesion, and the like. Meanwhile, the complex blood flow movement enables the implantation instrument to be easily adhered to autologous tissues, so that the implantation instrument fails, even thrombus is generated, and the life is threatened once the implantation instrument is dropped. In summary, although the above-described techniques have certain respective effects on valve repair, in the field of transcatheter interventional surgery for treatment of incomplete valve closure, there is a need for a prosthesis with adjustable position, accurate positioning and firm anchoring, which is less prone to premature thrombosis, is less prone to adhesion with the original tissue, and can cope with various degrees and positions of disease.

The invention content is as follows:

the invention aims to overcome the limitation of the prior art, and provides an implantation instrument for preventing valve regurgitation and a delivery system thereof aiming at valve partial prolapse.

The purpose of the invention is realized by the following technical scheme:

an implantation instrument for preventing valve regurgitation comprises an opening mechanism, a core piece and a closing assisting piece, wherein the opening mechanism is connected with the core piece, the far end of the closing assisting piece is connected with the opening mechanism, the closing assisting piece is flexible, the closing assisting piece is positioned between autologous valve leaflets of a patient in a free state, the near end of the closing assisting piece is provided with a limiting piece, the far end of the limiting piece is connected with the closing assisting piece, the near end of the limiting piece is connected with the core piece or fixed on the cardiac tissue of the patient, the closing assisting piece can be attached to the core piece along with the closing of the autologous valve of the patient, and at least one end of the core piece is fixed on the cardiac tissue of the patient.

The purpose of the invention can be further realized by the following technical scheme:

preferably, the distraction mechanism is located partially or entirely within the patient's atrium, or the distraction mechanism is located entirely within the patient's own atrioventricular valve annulus within the patient's atrium.

Preferably, the sum of the length of the closing-assist member and the length of the limiting member is greater than the linear distance between the distal end of the closing-assist member and the proximal end of the limiting member.

Preferably, the distal end of the obturator is at a greater perpendicular distance from the core member than the proximal end of the obturator.

Preferably, the limiting member is in a shape of a filament, a line or a strip.

Preferably, the stop member extends from a proximal end of the closing assist member.

Preferably, the retaining member is of unitary construction with the core member.

Preferably, the core member is a flexible rod, or the core member is a combination of a flexible rod and a rigid rod. The benefit of such a design is that the coaptation member can adaptively fill the site of native valve regurgitation.

Preferably, the flexible rod is of a spring-like structure. More preferably, the surface of the spring-like structure is coated with a polymer film. More preferably, a non-retractable wire or rod is disposed on the spring-like structure, and two ends of the wire or rod are respectively connected with two ends of the spring-like structure, so that the spring-like structure cannot axially retract.

Preferably, the core is a hollow tube, or the core portion is a hollow tube.

More preferably, the hollow tube is provided with a hole, and the limiting member reaches the outside of the left ventricle through the hole and is fixed on the heart tissue of the patient.

Preferably, the core member is linear or the core member is ribbon-shaped.

Preferably, the core is a combination of a rod, tube, wire or ribbon.

Preferably, the core is provided with a buffer means between the distal end of the closing element and the proximal end of the closing element in the axial direction of the core, so that the closing element can increase the fitting area with the core when pushed towards the core by the patient's own leaflet.

Preferably, the cushioning device is a column, olive, sheet or balloon. More preferably, the cushioning means is flexible or resilient.

Preferably, the spreading mechanism is a bow-tie structure, a petal-shaped structure, a star-shaped structure, a spiral structure, an annular structure or a grid-shaped structure. Preferably, the expanding mechanism is formed by winding a single-strand or multi-strand shape memory alloy wire, or is formed by engraving a shape memory alloy pipe.

Preferably, an auxiliary opening mechanism is further arranged on the outer edge of the opening mechanism, the auxiliary opening mechanism is of a wave-shaped structure, the diameter of the auxiliary opening mechanism is larger than that of the opening mechanism on the cross section perpendicular to the core piece, and the maximum diameter of the auxiliary opening mechanism contacts with the atrial wall of the patient, so that the distal end part of the closing-assisting piece is not attached to the cardiac tissue of the patient.

Preferably, on the longitudinal section of the core member, the projection of the distraction mechanism is a stepped structure, the stepped structure has a first step and a second step, the diameter of the first step is larger than that of the second step, the maximum diameter of the first step contacts with the atrial wall of the patient, and the distal end of the closure aid is connected with the second step, so that the distal end part of the closure aid is not attached to the cardiac tissue of the patient.

Preferably, the spreader mechanism is integral with the core member. More preferably, the core piece is formed by extending a single-strand shape memory alloy wire of the opening mechanism, or the core piece is formed by extending and winding a plurality of strands of shape memory alloy wires of the opening mechanism, or the core piece and the opening mechanism are integrally carved for a shape memory alloy pipe.

Preferably, the portion of the core member associated with the spreading mechanism is perpendicular to the plane of the spreading mechanism.

Preferably, an intersection point of the plane where the core member and the distraction mechanism are located is located at a midpoint position of the distraction mechanism, or an intersection point of the plane where the core member and the distraction mechanism are located is not coincident with the midpoint of the distraction mechanism.

Preferably, the maximum width of the closing-assisting element is smaller than the maximum width of the single self-valve leaf, and the length of the closing-assisting element is larger than the height of the self-valve leaf.

Preferably, the closing member is a single piece, or the closing member is a plurality of pieces, or the closing member is cylindrical.

Preferably, the proximal end of the obturator is provided with a skeletal structure that prevents the obturator from wrinkling or being compressed resulting in a reduction in size. The framework structure is a straight-line structure, a triangular structure, a polygonal structure, an annular structure, a wave-shaped structure, a sawtooth structure or a grid structure, or the framework structure is a combination of the structures.

More preferably, the distal end of the stopper is connected to the skeleton structure. More preferably, the distal end of the position-limiting member is connected to the skeleton structure by sintering, welding, gluing or stitching, and the proximal end of the position-limiting member is connected to the core member by sintering, welding, gluing or stitching.

Preferably, a fixing member is provided at one end of the core member.

Preferably, both ends of the core member are secured to the patient's heart tissue.

The other purpose of the invention is realized by the following technical scheme:

the utility model provides a transvascular approach is used for preventing palirrhea implant instrument conveying system of valve, conveying system includes conveying sheath pipe and delivery handle, the proximal end of conveying sheath pipe with delivery handle fixed connection, the conveying sheath pipe is loaded with foretell the implant instrument that is used for preventing valve regurgitation, conveying system still is provided with and is used for propelling movement like the pusher of mounting.

Preferably, the pushing device is located in the delivery sheath. Preferably, the delivery sheath further comprises a fixing member delivery sheath, the pushing device is located in the fixing member delivery sheath, and the fixing member is loaded in the fixing member delivery sheath.

Compared with the prior art, the invention has the advantages that:

1. different from the integral valve replacement technology, the invention keeps the motion functions of the autologous valve leaflets and the valve leaflets, prevents the prolapsed valve leaflets from overturning through the closing assisting component, thereby achieving the purpose of preventing the valve from regurgitation, and has the advantages of less implants, good hemodynamics and the like.

2. Different from the prior art that the occlusion aid is fixed on the atrial tissue by using the anchoring needle, one end of the core piece is fixed on the cardiac tissue of the patient, and the fixation of the implantation instrument is realized by the core piece, so that the delivery device is greatly simplified, the operation difficulty is reduced, the anchoring effect is enhanced, and the functions of adjustability, sheath re-entry, recyclability and the like can be realized by using the core piece.

3. In the present invention, the sum of the length of the closing member and the length of the stopper is greater than the linear distance between the distal end of the closing member and the proximal end of the stopper, so that the closing member can be fitted to the core member without being turned over in a free state.

4. According to the invention, on the longitudinal section of the core piece, the projection of the distraction mechanism is of a stepped structure, the stepped structure is provided with a first step and a second step, the diameter of the first step is larger than that of the second step, the maximum diameter part of the first step is contacted with the atrium wall of the patient, and the distal end of the closure aid is connected with the second step, so that the design limits the movement range of the implantation instrument in the atrium on one hand, and improves the overall stability of the implantation instrument on the other hand; on the other hand, the positioning of the instrument is more accurate, and the anchoring effect of the implanted instrument is enhanced; in addition, there is blood flow between the distal end of the member and the patient's heart tissue, preventing the distal end portion of the member from adhering to the tissue adjacent the patient's valve annulus over prolonged contact.

5. In the present invention, the core member is a flexible rod, or the core member is a combination of a flexible rod and a rigid rod. The benefit of this design is that the coaptation element can adaptively fill the site of mitral regurgitation.

6. The core member of the invention is provided with a buffer device which is positioned between the far end of the closing-assisting element and the near end of the closing-assisting element in the axial direction, so that the closing-assisting element can increase the fitting area with the core member when the closing-assisting element is pushed to the core member by the patient self-valve leaf.

7. The proximal end of the obturator of the present invention is provided with a skeletal structure that prevents the obturator from wrinkling or being compressed resulting in a reduction in size.

8. The maximum width of the closing aid is smaller than the maximum width of the single self-body valve leaf, so that the influence of the over-width of the closing aid on the closing function of other adjacent valve leaves can be avoided, the circumferential adjustment can be carried out to enable the closing aid to be placed at the most appropriate prolapsed part, the number of implants is small, the complications are low, the self-closing valve is suitable for the valve ring sizes of different patients, the adaptation symptoms are expanded, and the product specification can be reduced by manufacturers.

Drawings

Fig. 1a and 1b show schematic views of an embodiment of the invention.

Fig. 2a and 2b show schematic views of one embodiment of a closure aid of the present invention.

Figures 3 a-3 d show schematic views of various embodiments of a closure aid of the present invention.

Fig. 4a-4 d show schematic views of various embodiments of the core of the invention.

Fig. 5a-5c show schematic views of an embodiment of the invention. Wherein fig. 5b and 5c are cross-sectional views of fig. 5 a.

Fig. 6 a-6 e show schematic diagrams of various embodiments of the present invention.

Fig. 7a and 7b show schematic views of another embodiment of the present invention.

Fig. 8a and 8b show schematic views of another embodiment of the present invention, wherein fig. 8b is a partially enlarged view of fig. 8 a. Figure 8c shows a schematic view of an embodiment of the invention. Fig. 8 d-8 f show schematic views of another embodiment of the present invention.

Fig. 9 a-9 d show schematic diagrams of various embodiments of the present invention.

FIGS. 10a-10d show schematic views of various embodiments of the distraction mechanism of the invention.

Fig. 11a-11 d show schematic diagrams of various embodiments of the present invention.

Fig. 12a and 12b show schematic views of another embodiment of the present invention, wherein fig. 12b is a cross-sectional view of fig. 12 a. Fig. 12c and 12d show schematic views of another embodiment of the present invention.

Fig. 13 a-13 f show schematic diagrams of various embodiments of the present invention.

Fig. 14 a-14 e show schematic diagrams of various embodiments of the present invention.

Fig. 15 a-15 d show schematic diagrams of various embodiments of the present invention.

Fig. 16 a-16 d show schematic diagrams of various embodiments of the present invention.

Fig. 17 a-17 c show schematic diagrams of various embodiments of the present invention.

Fig. 18 a-18 d show schematic diagrams of various embodiments of the present invention.

Fig. 19 a-19 d show schematic diagrams of various embodiments of the present invention.

Fig. 20a shows a schematic view of an embodiment of the implantation instrument according to the invention, fig. 20b shows a schematic view of an embodiment of the delivery system according to the invention, fig. 20 c-20 i show a schematic view of the working principle of the delivery system according to fig. 20b, wherein fig. 20f is an enlarged view in partial section of fig. 20 e.

Fig. 21a shows a schematic view of another embodiment of an implantation instrument according to the invention, fig. 21b shows a schematic view of another embodiment of a delivery system according to the invention, fig. 21 c-21 l show a schematic view of the working principle of the delivery system according to fig. 21b, wherein fig. 21f is an enlarged view in partial section of fig. 21e, and fig. 21j is an enlarged view in partial section of fig. 21 i.

Fig. 22a to 22e are schematic views showing another embodiment of the present invention, wherein fig. 22c and 22e are partially enlarged views of fig. 22a, respectively.

Fig. 23a-23c show schematic views of another embodiment of the present invention, wherein fig. 23b is a partial enlarged view of fig. 23 a. Fig. 23 d-23 e show schematic diagrams of various embodiments of the present invention.

The specific implementation mode is as follows:

in order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings and examples.

The distal end of the present invention refers to the end away from the apex of the heart, and the proximal end refers to the end near the apex of the heart.

The first embodiment is as follows:

as shown in fig. 1a and 1B, an implanting apparatus 100 for preventing valve regurgitation comprises a distraction mechanism 110, a core member 120 and a closing aid 130, wherein the distraction mechanism 110 is connected with a distal end portion of the core member 120, a distal end of the closing aid 130 is connected with the distraction mechanism 110, the closing aid 130 is flexible, the distraction mechanism 110 is positioned in an atrium of a patient in a free state, the closing aid 130 is positioned between native valve leaflets of the patient, a proximal end of the closing aid 130 is provided with a stopper 140, a distal end of the stopper 140 is connected with a proximal end portion of the closing aid 130, a proximal end of the stopper 140 is connected with the core member 120, so that the closing aid 130 can be attached to the core member 120 without overturning in the free state, a perpendicular distance a between the distal end of the closing aid 130 and the core member 120 is larger than a perpendicular distance B between the proximal end of the closing aid 130 and the core member 120, the proximal end of core member 120 is secured to the patient's apical tissue. The implant device is used for treating mitral insufficiency caused by anterior mitral valve prolapse. Different from the whole valve replacement technology, the implantation instrument keeps the movement functions of the autologous valve leaflets and the valve leaflets, prevents the prolapsed valve leaflets from overturning through the closing assisting component 130, thereby achieving the purpose of preventing the valve from regurgitating, and has the advantages of less implants, good hemodynamics and the like. Unlike the prior art in which an anchoring needle is used to fix the occlusion aid to the atrial tissue (see patent CN201410322594.8 for details), in the present invention, the proximal end of core member 120 is fixed to the apical tissue of the patient, and the fixation of the implantation device is achieved through core member 120, which not only greatly simplifies the delivery device, reduces the difficulty of operation, and enhances the anchoring effect, but also achieves the functions of adjustability, re-sheathing and recyclability by means of core member 120.

When the native valve leaflets close, the prolapsed anterior valve leaflet fits against one side of the closing aid 130 under the push of blood pressure, and since the closing aid 130 is flexible, the other side of the closing aid 130 fits against the core 120, closing in cooperation with the intact posterior valve leaflet. When the native leaflets open, the closure aid 130 can be pushed away from the core by the blood pressure, and as the leaflets open, the blood flow flushes the surface of the closure aid 130, so that thrombus is not easily generated on the surface of the closure aid 130. As a preferred embodiment, as shown in fig. 2a and 2b, the sum of the length L1 of the closing element 130 and the length L2 of the limiting element 140 is greater than the linear distance L3 between the distal end of the closing element 130 and the proximal end of the limiting element 140. The benefit of this design is that the closure aid 130 will not flip inward or outward due to too much movement while ensuring that it can follow the native leaflets.

In one embodiment, as shown in fig. 3a and 3b, the limiting member 140 is in a shape of a wire, a thread, or a strip, and the material of the limiting member 140 includes a metal material, teflon, polyethylene, polypropylene, dacron, or an animal-derived material. In another embodiment, as shown in fig. 3c and 3d, the retaining member 140 extends proximally of the closing assist member 130.

Core 120 is a flexible rod or core 120 is a combination of a flexible rod and a rigid rod. The beneficial effect of the design is that the closing-assisting part can adaptively fill the regurgitation part of the native valve, and the positioning requirement on the device is reduced. In one embodiment, as shown in fig. 4a-4c, the flexible rod is a spring-like structure, the surface of which is covered by a polymer film 121, and the film 121 is used to prevent blood from entering the spring-like structure to form thrombus and prevent the core member 120 from hardening. Preferably, as shown in fig. 4b and 4c, a non-retractable wire or rod is disposed on the spring-like structure, and both ends of the wire or rod are respectively connected with both ends of the spring-like structure, so that the spring-like structure cannot axially retract and can only move along the conical surface formed by the proximal end of the core member (as shown in fig. 4d), which is advantageous in that the self-adaptive filling of the regurgitation site of the native valve by the closing assisting element can be realized without affecting the function that the closing assisting element can adaptively fill the regurgitation site of the native valve, and simultaneously, the closing assisting element can be prevented from moving in the axial direction to a larger extent to scrape the native valve leaflet tissue of the patient, and finally, the functions of adjustment, sheath re-entering and recovery can be realized by the.

In one embodiment, as shown in fig. 5a-5c, a cushioning device 150 is disposed on the core member 120, the cushioning device 150 being located between the distal end 1300 of the closure member 130 and the proximal end 1301 of the closure member 130 in the axial direction of the core member 120, the cushioning device 150 being flexible or elastic. The buffer device 150 is a balloon, the cross section of the balloon in the radial direction is rectangular, and the cross section of the balloon in the vertical direction is oval, so that when the closing aid 130 is pushed to the core member 120 by the autologous valve leaflet of the patient, the fitting area of the closing aid 130 and the core member 120 can be increased, and the gap formed between the core member 120 and the closing aid 130 during fitting can be reduced. The buffer device 150 is flexible, and is designed to ensure that the patient's native valve leaflet will not be damaged when the closing aid 130 is attached to the buffer device 150.

In one embodiment, as shown in fig. 6a and 6b, the distraction mechanism 110 is a bow-tie structure formed by winding a single strand of shape memory alloy wire, and the distraction mechanism 110 and the core member 120 are of an integral structure. Preferably, core member 120 is formed by a single strand of a shape memory alloy wire that extends from distractor mechanism 110. The intersection of the core 120 with the plane of the distracting mechanism 110 is located at the midpoint of the distracting mechanism 110.

In another embodiment, as shown in fig. 6c-6e, the intersection of core 120 with the plane of spreader mechanism 110 is not coincident with the midpoint of spreader mechanism 110, which provides an eccentric configuration that has the benefit of biasing the position of the obturator 130 more toward the mitral valve prolapse area, and thus provides a better resistance to valve regurgitation.

In one embodiment, as shown in FIGS. 7a and 7b, the closure member 130 is a single piece, the material of the closure member 130 is PTFE, and the distal end 1300 of the closure member 130 is attached to the deployment mechanism 110 by sintering. The proximal end of the closure member 130 is provided with a backbone structure 131 to prevent the closure member 130 from wrinkling or to prevent the closure member 130 from being compressed resulting in a reduced size. The framework structure 131 is a triangular structure, the framework structure 131 is formed by winding a metal memory material wire, and the framework structure 131 is connected with the closing-assisting piece 130 in a sintering mode. The three limiting members 140 are provided, and the distal ends of the three limiting members are connected to the framework structure 131, so that the closing-assist member 130 is not easy to turn left or right during the movement process, and the stability is better. The distal end 1400 of the retainer 140 is bonded to the backbone structure 131 by sintering, welding, gluing, or stitching, and the proximal end 1401 of the retainer 140 is bonded to the core 120 by sintering, welding, gluing, or stitching.

In one embodiment, as shown in fig. 8a and 8b, the proximal end of core member 120 is provided with a securing member 160. The fixing member 160 is in the shape of thread, thread or strip, one end of the fixing member 160 is fixed on the core member 120, and the other end is free. In the free state, the free end 1600 of the anchor 160 is anchored to apical tissue or to a surgical incision pad.

In another embodiment, as shown in fig. 8c, the fixing member 160 is a suction cup-shaped member adapted to the contour of the apex of the heart, the surface of the proximal portion of the core member 120 is provided with a screw thread, the fixing member 160 is provided with a screw hole, and the proximal portion of the core member 120 is screw-engaged with the fixing member 160.

In yet another embodiment, as shown in fig. 8d-f, the fixing member 160 is a suction cup-shaped member adapted to the contour of the apex of the heart, and the fixing member 160 is provided with a boss 161, a fastener 162 and a nut 163. The boss 161 is hollow, the fastener 162 is located in the boss 161, and threads are arranged on the inner surface of the boss 161. The fastener 162 is hollow, the outer diameter of the fastener 162 matches the inner diameter of the boss 161, the inner diameter of the fastener 162 matches the diameter of the proximal portion of the core member 120, the core member 120 is located in the fastener 162, the top end of the fastener 162 is provided with a bevel 1620, and the fastener 162 is provided with parallel cutting seams 1621 along the axial direction. A bevel 1630 is provided in the nut 163 at an angle greater than the bevel 1620 in the tip of the fastener 162, and when the nut 163 is threadably engaged with the boss 161, the gap of the cut 1621 in the fastener 162 is reduced, so that the core 120 is secured between the fasteners 162.

The second embodiment is as follows:

as shown in fig. 9a and 9b, an implanting apparatus 200 for preventing valve regurgitation comprises an opening mechanism 210, a core member 220 and a closing aid 230, wherein the opening mechanism 210 is connected with the distal end portion of the core member 220, the distal end of the closing aid 230 is connected with the opening mechanism 210, the closing aid 230 is flexible, when in a free state, the opening mechanism 210 is positioned in the atrium of the patient, the closing aid 230 is positioned between the leaflets of the patient, the proximal end of the closing aid 230 is provided with a stopper 240, the distal end of the stopper 240 is connected with the proximal end portion of the closing aid 230, the proximal end of the stopper 240 is fixed on the cardiac apical tissue of the patient, so that the closing aid 230 can fit the core member 220 and cannot turn over when in the free state, and the proximal end of the core member 220 is fixed on the cardiac apical tissue of the patient.

As shown in fig. 9b and 9c, the core member 220 is a flexible rod, or the core member 220 is a combination of a flexible rod and a rigid rod. The core member 220 is a hollow tube, or the core member 220 is a hollow tube in part, the stopper 240 is a wire, the distal end of the stopper 240 is connected to the proximal end portion of the closing member 230, the proximal end of the stopper 240 passes through the hollow tube 220 to the outside of the left ventricle, after the implantation instrument is completely released, the effect of the closing member 230 on preventing valve regurgitation is evaluated by ultrasound, the tightness of the stopper 240 is adjusted, and finally the proximal end of the stopper 240 is fixed on the apical tissue of the patient. In one embodiment, the hollow tube 220 is provided with a hole 221, and the stopper passes through the hole 221 to the outside of the left ventricle and is fixed to the apical tissue of the patient.

In one embodiment, as shown in fig. 10a-10d, the distractor 210 is a helical structure or a ring structure, the distractor 210 is formed by winding a plurality of shape memory alloy wires, and the distractor 210 is connected to the distal portion of the core member 220 by sintering, welding, gluing, or stitching.

In one embodiment, as shown in fig. 11a-11c, the maximum width of the closing aid 230 is smaller than the maximum width of the single native leaflet, so that the design can not only avoid the influence of the too wide closing aid on the closing function of other adjacent leaflets, but also can be adjusted circumferentially to place the closing aid at the most suitable prolapse position, so that the number of implants is small, the complications are low, and the annulus size of different patients can be adapted, the adaptation can be expanded, and the manufacturer can reduce the product specification. As shown in fig. 11d, the length of the closing aid 230 is greater than the height of the self-body valve leaflet, so that the design can reduce the positioning precision requirement of the implantation instrument, adapt to the anatomical structure of different patients and ensure that the self-body valve leaflet can be jointed with the closing aid when the self-body valve leaflet is freely closed.

In one embodiment, as shown in fig. 12a and 12b, the closure aid 230 is in two pieces, corresponding to the position of the patient's anterior and posterior flaps, respectively. The core member 220 is provided with a buffer device 250, the buffer device 250 is flexible, and the buffer device 250 is columnar. As shown in fig. 12c and 12d, the occlusion piece 230 is made of an animal-derived material, preferably bovine pericardium material, and a hole 232 is formed on a portion of the occlusion piece 230 near the opening mechanism 210, so that blood can flow through the hole 232 and the occlusion piece 230 is prevented from adhering to the autologous tissues of the patient. The distal end of the closing assist member 230 extends with a plurality of wires that are wound around the opening mechanism 210. The closing aid 230 is provided with a stopper 240 at a proximal end thereof, a distal end of the stopper 240 is connected to the proximal portion of the closing aid 230, and a proximal end of the stopper 240 is fixed to the apical tissue of the patient.

In one embodiment, the proximal end of the closure member 230 is provided with a backbone structure 233 that prevents the closure member 230 from wrinkling or prevents the closure member 230 from being compressed resulting in a reduced size. The skeleton structure 233 is a straight-line structure (fig. 13a), a triangular structure (fig. 13b), a polygonal structure (fig. 13c), or a ring structure, or the skeleton structure 233 is a combination of the above structures. The skeleton structure 233 is composed of a single or a plurality of support rods, and the skeleton structure 233 is connected with the closing aid 230 by welding.

In another embodiment, as shown in fig. 13d and 13e, the skeleton structure 233 is a wave-shaped structure or a zigzag structure, and peaks and valleys of the wave-shaped structure or tips of the zigzag structure are wound in a ring shape. The framework 233 is formed by winding a metal memory material wire. The backbone structure 233 is attached to the closure member 230 by gluing.

In yet another embodiment, as shown in fig. 13f, the skeleton structure 233 is a grid-like structure, and the skeleton structure 233 is integrally cut. The skeletal structure 233 is attached to the closure member 230 by stitching.

In one embodiment, as shown in FIG. 14a, the proximal end of the core member 220 is provided with a securing member 260. The core member 220 has a hollow tube at its proximal end, and a hole 222 is formed in the wall of the hollow tube. The distal-most end of the anchor 260 is pointed and the distal portion of the anchor 260 is pre-shaped to one or a combination of the following shapes: helical (fig. 14b), circumferential (fig. 14c), curved, a combination of curved and straight (fig. 14D), bifurcated double hook (fig. 14e), 3D curved, multi-segment curved, with the distal end of the anchor 260 being unbarbed or having one or more barbs. After transapical delivery of the implanting device to the target site by the delivery device, the implanting device is fully released, the axial position of the obturator 230 is adjusted by the core member 220, after the position is established, as shown in fig. 15a, the securing member 260 is pushed in from the proximal end of the core member 220, and in the free state, the distal-most end of the securing member 260 is passed out of the hole 222 in the core member 220 and penetrates into the apical tissue. In another embodiment, as shown in fig. 15b, the fixing element 260 is pre-placed in the hollow tube of the proximal portion of the core member 220, the distal end of the fixing element 260 is located at the distal end of the hole 222 on the core member 220, the proximal end of the fixing element 260 is provided with a pulling wire 261, one end of the pulling wire 261 is free outside the core member 220, after the implantation device is completely released, the axial position of the closure element 230 is adjusted through the core member 220, after the position is determined, the pulling wire 261 is pulled, and in the free state, the distal-most end of the fixing element 260 penetrates out of the hole 222 on the core member 220 and penetrates into the apical tissue. In another embodiment, as shown in fig. 15c and 15d, the fixation member 260 is two anchoring

needles

2601 and 2602 fixedly connected end to end, and the fixation member 260 is compressed within a fixation member sheath 2603 before entering the body, the fixation sheath 2603 being located within the core member 220. After entering the body, the fixing member sheath 2603 is withdrawn to fix the proximal anchoring needle 2601 to the apical tissue, the core 220 is then adjusted up and down, and the fixing member sheath 2603 is withdrawn to release the distal anchoring needle 2602 to be inserted into the core 220 for fixation.

The third concrete embodiment:

as shown in fig. 16a, an implanting apparatus 300 for preventing valve regurgitation comprises a propping mechanism 310, a core member 320 and a closing aid 330, wherein the propping mechanism 310 is connected with the distal end part of the core member 320, the intersection point of the core member 320 and the plane of the propping mechanism 310 is located at the midpoint position of the propping mechanism 310, the distal end of the closing aid 330 is connected with the propping mechanism 310, the closing aid 330 is flexible, when in a free state, the propping mechanism 310 is located in the atrium of the patient, the closing aid 330 is located between the native valve leaflets of the patient, the proximal end of the closing aid 330 is provided with a stopper 340, the distal end of the stopper 340 is connected with the proximal end part of the closing aid 330, and the proximal end of the stopper 340 is fixed on the heart tissue of the patient or connected with the core member 320 (as shown in fig. 16 b), so that the closing aid 330 can fit the core member 320 and can not turn over when in the free state, the distal end of the obturator 330 is spaced a greater vertical distance from the core member 320 than the proximal end of the obturator 330 is spaced from the core member 320, and the proximal end of the core member 320 is secured to the patient compartment.

In one embodiment, the core 320 is a flexible rod, or the core 320 is a combination of a flexible rod and a rigid rod. The distraction mechanism 310 is in a petal-shaped structure (fig. 16c) or a star-shaped structure (fig. 16d), and the distraction mechanism 310 is formed by winding a plurality of strands of shape memory alloy wires. The opening mechanism 310 and the core piece 320 are of an integral structure, and the core piece 320 is formed by extending and winding a plurality of strands of shape memory alloy wires of the opening mechanism 310.

In one embodiment, the closing-assist element 330 is two pieces, as shown in fig. 17a, a limiting element 340 is disposed at a proximal end of the closing-assist element 330, and the limiting element 340 is a thread, a wire, or a strip. In a free state, the distal end of the stopper 340 on the patient's anterior valve side is connected to the proximal end portion of the closing aid 330 on the patient's anterior valve side, and the proximal end of the stopper 340 is connected to the core member 320; the distal end of the retaining member 340 on the side of the patient's posterior valve is connected to the proximal portion of the obturator 330 on the side of the patient's posterior valve, and the proximal end of the retaining member 340 is fixed to the patient's apical tissue. The closure member 330 is a sheet of material of animal origin, preferably porcine pericardium. The distal end of the closure member 330 is sewn to the deployment mechanism 310 by a suture.

In another embodiment, as shown in fig. 17b, the core member 320 is partially or entirely a hollow tube, the closing-assist member 330 is two pieces, a retaining member 340 is disposed at the proximal end of the closing-assist member 330, and the retaining member 340 is a thread, a wire, or a strip. In a free state, the stopper 340 at one side of the anterior valve of the patient is a single piece, the distal end of the stopper 340 is connected to the proximal portion of the closing aid 330, and the proximal end of the stopper 340 is fixed on the patient compartment through the hollow tube 320; the two limiting members 340 are positioned on one side of the posterior valve of the patient, the distal ends of the limiting members 340 are connected to the proximal end part of the closing-assist member 330, and the proximal ends of the limiting members 340 are fixed on the apical tissue of the patient.

In yet another embodiment, as shown in fig. 17c, the core member 320 is partially or entirely a hollow tube, the hollow tube is provided with a hole, the closing-assisting member 330 is two pieces, the proximal end of the closing-assisting member 330 is provided with a retaining member 340, and the retaining member 340 is in a shape of a thread, a wire, or a strip. In a free state, the limiting member 340 at the anterior valve side of the patient is a single member, the distal end of the limiting member 340 is connected to the proximal portion of the closing member 330 at the anterior valve side of the patient, and the limiting member 340 is fixed to the patient compartment through the hole; the number of the stoppers 340 on the patient's posterior valve side is three, the distal ends of the stoppers 340 are connected to the proximal portion of the closing aid 330 on the patient's posterior valve side, and the proximal ends of the stoppers 340 are fixed to the papillary muscles and ventricular muscles of the patient. The core piece 320 is provided with a fixing piece 360 at the proximal end, the fixing piece 360 is a stent with two large ends and a small middle, and the stent is formed by weaving and shaping a nickel-titanium alloy wire. When the device is fully released, the patient compartment musculature is clamped at both ends of the stent.

The fourth concrete embodiment:

as shown in fig. 18a, an implanting apparatus 400 for preventing valve regurgitation comprises a distraction mechanism 410, a core member 420 and a closing aid 430, wherein the distraction mechanism 410 is connected with the middle of the core member 420, the closing aid 430 is connected with the distraction mechanism 410 at the distal end, the closing aid 430 is flexible, the closing aid 430 is one-piece, the distraction mechanism 410 is positioned in the atrium of the patient in the free state, the closing aid 430 is positioned between the native leaflets of the patient, the proximal end of the closing aid 430 is provided with a stopper 440, the distal end of the stopper 440 is connected with the proximal portion of the closing aid 430, the proximal end of the stopper 440 is fixed on the papillary muscle of the patient, so that the closing aid 430 can be attached to the core member 420 and can not turn over in the free state, the perpendicular distance between the distal end of the closing aid 430 and the core member 420 is larger than the perpendicular distance between the proximal end of the closing aid 430 and the core member 420, one end of the core piece 420 is secured to the atrium of the patient.

In one embodiment, a cushioning device 450 is disposed on core member 420, cushioning device 450 is axially between the distal end of closure member 430 and the proximal end of closure member 430, cushioning device 450 is olive-shaped, and cushioning device 450 is a flexible balloon.

In one embodiment, the distracting mechanism 410 is a grid-like structure, and the distracting mechanism 410 is carved out of shape memory alloy tubing. As shown in fig. 18b, the core member 420 is perpendicular to the plane of the distracting mechanism 410, and the intersection point of the core member 420 and the plane of the distracting mechanism 410 is located at the midpoint of the distracting mechanism 410. In another embodiment, as shown in FIG. 18c, the core 420 forms an angle a with the plane of the distracting mechanism 410, and the intersection of the core 420 with the plane of the distracting mechanism 410 does not coincide with the midpoint of the distracting mechanism 410. The core member 420 and the expanding mechanism 410 are integrally carved from shape memory alloy pipes.

In another embodiment, as shown in fig. 18d, the implant device is passed through the left atrial appendage to the left atrium. One end of the core piece 420 is provided with a fixing piece 460, the fixing piece 460 is a stent with two large ends and a small middle, the stent is formed by integrally cutting and shaping a nickel-titanium alloy tube, and the stent is coated with a film. When the device 400 is completely released, one end of the stent is positioned in the left auricle of the patient, and the other end of the stent is positioned in the left atrium of the patient, so that the left auricle plugging is completed while the implanted device is fixed, and the thrombus in the left auricle is prevented from falling off.

The fifth concrete embodiment:

as shown in fig. 19a, an implanting device 500 for preventing valve regurgitation comprises an opening mechanism 510, a core member 520 and a closing aid 530, wherein the opening mechanism 510 is connected with the middle part of the core member 520, the distal end of the closing aid 530 is connected with the opening mechanism 510, the closing aid 530 is flexible, the closing aid 530 is cylindrical, the opening mechanism 510 is positioned in the atrium of the patient when in a free state, the closing aid 530 is positioned between the native valve leaflets of the patient, the proximal end of the closing aid 530 is provided with a stopper 540, the distal end of the stopper 540 is connected with the proximal part of the closing aid 530, the proximal end of the stopper 540 is fixed on the wall of the ventricle cavity, so that the closing aid 530 can be attached to the core member 520 without turning over when in the free state, the perpendicular distance between the distal end of the closing aid 530 and the core member 520 is larger than the perpendicular distance between the proximal end of the closing aid 530 and the core member 520, one end of the core 520 is secured to the atrial septum of the patient. The insertion instrument 500 is transvenously directed to the right atrium and punctured to the left atrium. The core member 520 is provided with a fixing member 560 at the proximal end thereof, the fixing member 560 is a stent with two large ends and a small middle, and the stent is formed by integrally cutting and shaping a nickel-titanium alloy tube. When the device is fully released, the patient's atrial septal musculature is clamped at both ends of the stent.

In one embodiment, as shown in fig. 19b, in a longitudinal cross-section of the core 520, the projection of the spreader mechanism 510 is a stepped structure having a first step 5101 and a second step 5102, the first step 5101 having a diameter greater than the second step 5102, the first step 5101 having a maximum diameter that contacts the patient's atrial wall, and the distal end of the closure aid 530 being connected to the second step 5102 such that the distal portion of the closure aid 530 does not conform to the patient's cardiac tissue. The design limits the movement range of the implantation instrument in the atrium on one hand, and improves the overall stability of the implantation instrument; on the other hand, the positioning of the instrument is more accurate, and the anchoring effect of the implanted instrument is enhanced; in addition, there is blood flow between the distal end of the obturator 530 and the patient's heart tissue, preventing the distal end of the obturator 530 from sticking to the tissue adjacent the patient's annulus due to prolonged contact.

Similar to the design concept of the stepped structure, in another embodiment, as shown in fig. 19c-d, an auxiliary opening mechanism 570 is further disposed at the outer edge of the opening mechanism 510, the auxiliary opening mechanism 570 is a wave-shaped structure, the diameter of the auxiliary opening mechanism 570 is larger than that of the opening mechanism 510 in the cross section perpendicular to the core member 520, and the maximum diameter of the auxiliary opening mechanism 570 contacts the atrial wall of the patient, so that the distal end portion of the closing member 530 does not fit with the cardiac tissue of the patient.

The sixth specific embodiment:

as shown in fig. 20a, an implanting apparatus 600 for preventing valve regurgitation comprises a propping mechanism 610, a core member 620 and a closing aid 630, wherein the propping mechanism 610 is connected with the core member 620, the distal end of the closing aid 630 is connected with the propping mechanism 610, the closing aid 630 is flexible, when in a free state, the propping mechanism 610 is positioned in the atrium of a patient, the closing aid 630 is partially positioned between the native valve leaflets of the patient, the proximal end of the closing aid 630 is provided with a stopper 640, the distal end of the stopper 640 is connected with the proximal end part of the closing aid 630, the proximal end of the stopper 640 is connected with the core member 620, and the closing aid 640 can partially fit the core member 620 along with the closing of the native valve of the patient. The core member 620 is in a linear shape, a fixing member 660 is provided at one end of the core member 620, and the end of the fixing member 660 is pointed. In the free state, the pointed end of the securing element 660 pierces the apical tissue such that the one end of the core element 620 is secured to the apex of the patient's heart.

As shown in fig. 20b, an implant device delivery system 800 for preventing valve regurgitation through a blood vessel comprises a delivery sheath 810 and a delivery handle 820, wherein the proximal end of the delivery sheath 810 is fixedly connected with the delivery handle 820, the above-mentioned implant device 600 for preventing valve regurgitation is loaded in the delivery sheath 810, and the delivery system 800 is further provided with a pushing device 830 for pushing the fixing member 660. In one embodiment, the pushing device 830 is located within the delivery sheath 810. The working principle of the implant device delivery system 800 will be further explained below:

1. as shown in fig. 20c, guidewire 801 is passed through left atrium 682 to left ventricle 683 using conventional means to access from inferior vena cava 680, puncturing interatrial septum 681;

2. as shown in fig. 20d, a protective sheath 802 is introduced over the guide wire 801, said protective sheath 802 having a fixation bend at the end to facilitate positioning of the mitral valve 684 in a central position;

3. as shown in fig. 20e and 20f, the delivery sheath 810 loaded with the implantation instrument 600 is introduced over a guidewire to a desired location;

4. as shown in fig. 20g, the pushing device 830 is operated such that the sharp end of the anchor 660 pierces the apical tissue;

5. as shown in fig. 20h, the delivery sheath 810 is withdrawn, causing the implant device 600 to be gradually released;

6. after the implantation device 600 is fully released, the delivery sheath and the protection sheath are sequentially withdrawn, and the guide wire is withdrawn after the conventional atrial septum is sealed, as shown in fig. 20 i.

The seventh specific embodiment:

as shown in fig. 21a, an implantation apparatus 700 for preventing valve regurgitation comprises a distraction mechanism 710, a core member 720 and a closure aid 730, wherein the distraction mechanism 710 is connected with the core member 720, the distal end of the closure aid 730 is connected with the distraction mechanism 710, the closure aid 730 is flexible, when in a free state, the distraction mechanism 710 is positioned in an atrium of a patient, the closure aid 730 is partially positioned between native valve leaflets of the patient, the proximal end of the closure aid 730 is provided with a stop 740, the distal end of the stop 740 is connected with the proximal end part of the closure aid 730, the proximal end of the stop 740 is connected with the core member 720, and the closure aid 740 can partially fit the core member 720 along with the closing of the native valve of the patient. The core member 720 is in a band shape, a buffer device 750 is disposed on the core member 720, and the buffer device 750 is in a sheet shape, and is specifically made by locally thickening the core member 720. A fixing member 760 is provided at one end of the core member 720, a connecting line 761 is connected to an end of the fixing member 760, and one end of the connecting line 761 is connected to the core member 720. The end of the fixing member 760 is pointed, and in a free state, the pointed end of the fixing member 760 penetrates into the apical tissue, so that one end of the core member 720 is fixed to the apex of the patient's heart.

As shown in fig. 21b, an implant device delivery system 900 for preventing valve regurgitation through a blood vessel comprises a delivery sheath 910 and a delivery handle 920, wherein the proximal end of the delivery sheath 910 is fixedly connected with the delivery handle 920, the delivery sheath 910 is loaded with the above-mentioned implant device 600 for preventing valve regurgitation, and the delivery system 900 is further provided with a pushing device 930 for pushing the fixing member 760. In one embodiment, the delivery sheath 910 further comprises a fastener delivery sheath 912, the pusher 930 is located within the fastener delivery sheath 912, and the fastener 760 and the connecting wire 761 are separately loaded within the fastener delivery sheath 912. the working principle of the implant device delivery system 900 is further described below:

1. as shown in fig. 21c, guidewire 901 is passed through left atrium 682 to left ventricle 683 using conventional means to access from inferior vena cava 680, puncturing interatrial septum 681;

2. as shown in fig. 21d, a protective sheath 902 is introduced along the guide wire 901, the protective sheath 902 having a fixed bend at its end to facilitate positioning of the center of the mitral valve 684;

3. as shown in fig. 21e and 21f, the anchor delivery sheath 912 loaded with the anchor 760 is introduced over a guidewire to the appropriate location;

4. as shown in fig. 21g, the pushing device 930 is operated such that the sharpened end of the anchor 760 penetrates the apical tissue;

5. as shown in fig. 21h, the fastener delivery sheath 912 is withdrawn, with the end of the fastener 760 connected to the connector 761 and exiting the body;

6. as shown in fig. 21i and 21j, the delivery sheath 910, loaded with the remainder of the implantation instrument 700, is introduced into position along the joining line 761;

7. as shown in fig. 21k, the delivery sheath 910 is withdrawn, causing the implant device 700 to be gradually released;

8. as shown in fig. 21l, the implantation instrument 700 is repositioned, the connection wires 761 are locked in position relative to the core member 720, and the delivery sheath and the protection sheath are sequentially withdrawn to conventionally occlude the atrial septum.

The eighth embodiment:

as shown in fig. 22a, an implanting apparatus 800 for preventing valve regurgitation comprises an expanding mechanism 810, a core 820 and a closing aid 830, wherein the expanding mechanism 810 is connected with the core 820, the distal end of the closing aid 830 is connected with the expanding mechanism 810, the closing aid 830 is flexible, when in a free state, the expanding mechanism 810 is positioned in an atrium of a patient, the closing aid 830 is partially positioned between native valve leaflets of the patient, a proximal end of the closing aid 830 is provided with a stopper 840, a distal end of the stopper 840 is connected with the closing aid 830 (as shown in fig. 22 b), a proximal end of the stopper 840 is connected with the core 820, and the closing aid 840 can partially fit with the core 820 along with the closing of the native valve of the patient. The distal end of the core 820 is located in the opening mechanism 810, as shown in fig. 22c, the opening mechanism 810 is provided with a pressing sheet 8101, the pressing sheet 8101 is shaped in a folded state, the core 820 is arranged in a core protecting sheath 8203, the up-down distance can be freely adjusted, the core protecting sheath 8203 is located in the pressing sheet 8101, and when the core protecting sheath 8203 is retracted, as shown in fig. 22d, the pressing sheet 8101 returns to the folded state, so that the distal end of the core 820 is fixedly connected with the opening mechanism 810.

As shown in fig. 22e, the core member 820 is composed of two

strands

8201 and 8202, wherein a proximal end of one strand 8201 is fixedly connected with a fixing member 860, and the other strand 8202 is wound around a distal end of the fixing member 860 and connected with a proximal end of the retaining member 840, and as a more preferred embodiment, the other strand 8202 and the retaining member 840 are integrally formed.

As another embodiment, shown in fig. 23a and 23b, the core member 820 is a combination of a tube member 8204 and two

wires

8201 and 8202, wherein the distal end of the wire 8201 and the distal end of the wire 8202 are fixedly connected to the proximal end of the tube member 8204, respectively, a fixing member 860 is fixedly connected to the proximal end of the wire 8201, and the wire 8202 is threaded through the distal end of the fixing member 860 and connected to the proximal end of the retaining member 840. A positioning needle 8205 is further arranged in the tube 8204, a joint of the opening mechanism 810 and the core member 820 is coated with terylene cloth 8102, and after the distance between the core member 820 and the tube member 8204 is adjusted up and down, as shown in fig. 23c, the positioning needle 8205 releases and pierces the tube member 8204 and the terylene cloth 8102, so that the distal end of the core member 820 is fixedly connected with the opening mechanism 810.

As another embodiment, as shown in FIG. 23d, the distraction mechanism 810 is a lattice stent, and in the free state, the distraction mechanism 810 is entirely located within the patient's mitral valve annulus.

As shown in FIG. 23e, the distracting mechanism 810 is partially positioned within the patient's atrium and partially positioned within the patient's mitral valve annulus. Both ends of the core 820 are secured to the patient's heart tissue.

Finally, it should be understood that the above-mentioned embodiments are merely preferred embodiments of the present invention, and not intended to limit the present invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An implantation instrument for preventing valve regurgitation, which comprises a spreading mechanism, a core member and a closing assisting member, wherein the spreading mechanism is connected with the core member, the distal end of the closing assisting member is connected with the spreading mechanism, the closing assisting member is flexible, the closing assisting member is positioned between autologous valve leaflets of a patient, the proximal end of the closing assisting member is provided with a limiting member, the distal end of the limiting member is connected with the closing assisting member, the proximal end of the limiting member is connected with the core member or fixed on the cardiac tissue of the patient, the closing assisting member can be attached to the core member along with the closing of the autologous valve of the patient, at least one end of the core member is fixed on the cardiac tissue of the patient, the sum of the length of the closing assisting member and the length of the limiting member is larger than the linear distance between the distal end of the closing assisting member and the proximal end of the limiting member, and an auxiliary spreading mechanism is further arranged at the outer edge of the, the auxiliary opening mechanism is of a wave-shaped structure, the diameter of the auxiliary opening mechanism is larger than that of the opening mechanism on the cross section perpendicular to the core piece, and the maximum diameter position of the auxiliary opening mechanism contacts with the atrial wall of the patient, so that the distal end part of the closing-assisting piece is not attached to the cardiac tissue of the patient.

2. The implant device for preventing valve regurgitation according to claim 1, wherein the core member is a flexible rod or a combination of a flexible rod and a rigid rod.

3. The implant device for preventing valve regurgitation according to claim 2, wherein the flexible rod is a spring-like structure, the surface of which is covered with a polymer membrane.

4. An implant device for use in preventing valve regurgitation according to claim 3 wherein the core is a hollow tube or the core sections are hollow tubes.

5. The implant device for preventing valve regurgitation according to claim 4, wherein the hollow tube is provided with a hole through which a proximal portion of the retainer is fixed to the patient's heart tissue.

6. The implant device for preventing valve regurgitation according to claim 1, wherein the core member is wire-like, or the core member is ribbon-like, or the core member is a combination of rods, tubes, wires or ribbons.

7. An implant device for use in preventing valve regurgitation according to claim 1 wherein the core is provided with cushioning means.

8. An implant device for preventing valve regurgitation according to claim 7 wherein the cushioning means is flexible or resilient.

9. The implant device for preventing valve regurgitation according to claim 1, wherein the distal end of the obturator is at a greater vertical distance from the core member than the proximal end of the obturator.

10. The implant device for preventing valve regurgitation according to claim 1, wherein the stop is a proximal extension of the obturator.

11. The implant device for preventing valve regurgitation according to claim 1, wherein the projection of the distracting mechanism is a stepped structure in a longitudinal section of the core member, the stepped structure having a first step and a second step, the first step having a larger diameter than the second step, the first step having a maximum diameter that contacts the patient's atrial wall, the distal end of the closure aid being connected to the second step such that the distal end portion of the closure aid does not conform to the patient's cardiac tissue.

12. The implant device for preventing valve regurgitation according to claim 1, wherein the core member is provided at one end with a securing member.

13. A transvascular delivery system for an implant device for preventing valve regurgitation, the delivery system comprising a delivery sheath and a delivery handle, the proximal end of the delivery sheath being fixedly connected to the delivery handle, wherein the delivery sheath is loaded with the implant device for preventing valve regurgitation of claims 1 to 12, the delivery system further being provided with a pusher for pushing the fixation member of claim 12.