Valve replacement system

Abstract

The invention provides a valve replacement system which is used for replacing a native atrioventricular valve and comprises a butt joint device, an anchoring device and a valve prosthesis. The docking device is configured to be positioned through the anchoring and locking device and provide an accommodating cavity; the anchoring and locking device comprises a plurality of anchoring pieces, a plurality of locking pieces and a plurality of flexible linear pieces, wherein the number of the locking pieces is the same as that of the anchoring pieces, and the number of the flexible linear pieces is the same as that of the anchoring pieces. In the deployment completion state, one end of a linear piece is correspondingly and fixedly connected with an anchoring piece, and the other end of the linear piece penetrates through the butt joint device and then is correspondingly and fixedly connected with a locking piece; at least one anchoring piece is anchored into ventricular tissue, and at least another anchoring piece is anchored into annulus tissue or atrial tissue; the linear piece is tensioned by the anchoring piece and the locking piece which are correspondingly located on the two opposite sides of the butt-joint device, so that the butt-joint device is pressed against the native valve ring to be positioned; the valve prosthesis is arranged in the containing cavity of the butt joint device in a penetrating mode and is reliably fixed by the butt joint device.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a valve replacement system. Background Technology

[0002] The human heart valves include the aortic valve, pulmonary valve, and atrioventricular valves, with the atrioventricular valves further divided into the mitral and tricuspid valves. These valves act as one-way valves, working in sync with the heart, allowing blood to flow downstream but preventing blood from flowing upstream. For example, the mitral valve allows blood to flow from the left atrium to the left ventricle but prevents blood from flowing from the left ventricle to the left atrium; the tricuspid valve allows blood to flow from the right atrium to the right ventricle but prevents blood from flowing from the right ventricle to the right atrium; the aortic valve allows blood to flow from the left ventricle to the aorta but prevents blood from flowing from the aorta to the left ventricle; and the pulmonary valve allows blood to flow from the right ventricle to the pulmonary artery but prevents blood from flowing from the pulmonary artery to the right ventricle.

[0003] Diseased heart valves often exhibit narrowing or regurgitation, which inhibits the valve's ability to control blood flow, reduces the heart's pumping efficiency, and can lead to life-threatening conditions such as heart failure. For severe valvular disease, prosthetic heart valves can be used to replace the diseased native heart valves.

[0004] Compared to the aortic or pulmonary valves, both the mitral and tricuspid valves have unique physiological and anatomical structures and a complex physiological environment below the valve annulus, making it quite difficult to reliably fix the valve prosthesis. Summary of the Invention

[0005] In view of this, the present invention aims to provide a valve replacement system that can solve the above problems or at least alleviate them to some extent.

[0006] The present invention provides a valve replacement system for replacing native atrioventricular valves, comprising a docking device, an anchoring device, and a valve prosthesis;

[0007] The docking device is configured to be positioned by the anchoring device and to provide a receiving cavity;

[0008] The anchoring device includes several anchoring elements, several locking elements of the same number as the anchoring elements, and several flexible linear elements of the same number as the anchoring elements;

[0009] In the deployed state: one end of the linear component is fixedly connected to an anchoring component, and the other end penetrates the docking device and is fixedly connected to a locking component; at least one anchoring component is anchored into ventricular tissue, and at least another anchoring component is anchored into valve annulus tissue or atrial tissue; the linear component is tensioned by the anchoring components and locking components located on opposite sides of the docking device, so that the docking device is pressed against the original valve annulus for positioning; the valve prosthesis is inserted into the receiving cavity of the docking device and positioned by the docking device.

[0010] In the valve replacement system of the present invention, when used to replace the native mitral or tricuspid valve, the valve prosthesis is positioned by a docking device, which is further positioned by an anchoring device. At least one anchoring member in the anchoring device is anchored into the ventricular tissue, and at least another anchoring member is anchored into the valve annulus tissue or atrial tissue. The linear member is tensioned by the corresponding anchoring members and locking members located on opposite sides of the docking device. By using the physical means of the tensioned linear member pulling the locking member, the docking device can be firmly pressed against the native valve annulus for positioning, and thus the valve prosthesis can also be reliably fixed by the docking device. Attached Figure Description

[0011] Figure 1 This is a schematic diagram of the valve replacement system of the present invention in the deployed state from one perspective;

[0012] Figure 2 This is a schematic diagram of the valve replacement system of the present invention in the deployed state from another perspective;

[0013] Figure 3 This is a perspective view of the first embodiment of the docking device in this invention;

[0014] Figure 4 This is a top view schematic diagram of the first embodiment of the docking device;

[0015] Figure 5 This is a longitudinal sectional view of the first embodiment of the docking device;

[0016] Figure 6 for Figure 3 An exploded three-dimensional diagram of the skeleton of the docking device;

[0017] Figure 7a , Figure 7b , Figure 7c They are respectively Figure 6 Replaceable examples of inner shelves;

[0018] Figure 8a for Figure 6 Structural diagram of the outer frame and panel skeleton;

[0019] Figure 8b for Figure 6Replaceable examples of the outer frame and panel skeleton;

[0020] Figure 9 This is a top view schematic diagram of a second embodiment of the docking device;

[0021] Figure 10 for Figure 9 A top view of the skeleton in the docking device shown;

[0022] Figure 11 This is a top view schematic diagram of the third embodiment of the docking device;

[0023] Figure 12 for Figure 11 A top view of the skeleton in the docking device shown;

[0024] Figure 13 , Figure 14 , Figure 15 These are, respectively, a three-dimensional schematic diagram, a front view schematic diagram, and a top view schematic diagram of the skeleton in the fourth embodiment of the docking device;

[0025] Figure 16 This is a schematic diagram of the anchor lock device in the completed deployment state in this invention;

[0026] Figure 17 for Figure 16 Schematic diagram of the anchoring component and linear component;

[0027] Figure 18 , Figure 19 They are respectively Figure 16 A schematic diagram of the locking element not locking the linear component and the locking element locking the linear component;

[0028] Figure 20 This is a three-dimensional schematic diagram of an embodiment of the valve prosthesis of the present invention;

[0029] Figure 21 for Figure 20 The diagram shown is a front view of the valve prosthesis.

[0030] Figure 22a , Figure 22b , Figure 22c , Figure 22d The optional structures of the first loading portion or the second loading portion in the valve prosthesis are shown respectively;

[0031] Figure 23 This is a schematic diagram of the valve prosthesis of the present invention deployed separately in a first position to replace the native aortic valve;

[0032] Figures 24 to 30 The deployment process of the valve replacement system of the present invention is shown;

[0033] in, Figure 24 , Figure 25 The implantation of the anchor is shown from different perspectives;

[0034] Figure 26 , Figure 27 The docking device is shown from different perspectives as it is conveyed along the linear component to the original tricuspid valve;

[0035] Figure 28 , Figure 29 The insertion and locking of the locking element are shown separately;

[0036] Figure 30 The deployment and positioning of the valve prosthesis within the docking device are shown.

[0037] Figure 31 This is a schematic diagram showing the further deployment of auxiliary anchoring components after the valve replacement system of the present invention has been deployed;

[0038] Figure 32 This is a schematic diagram of the further deployment of pacing leads after the valve replacement system of the present invention has been deployed. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Furthermore, the embodiments described below can be combined with each other as long as there is no contradiction or conflict, and the same or similar concepts or processes may not be repeated in some embodiments.

[0040] First, it should be noted that in this article, "proximal" refers to the end of the device or component closer to the operator, and "distal" refers to the end of the device or component farther from the operator; "inflow end" refers to the end located upstream of the blood flow, and "outflow end" refers to the end located downstream of the blood flow; "axial" refers to the direction that coincides with or is parallel to the central axis of the device or component. "Radial" refers to the direction that is perpendicular or approximately perpendicular to the axial direction and along the radius or diameter of the device or component. "Circumferential" refers to the direction surrounding the axial direction. For components applied to atrioventricular valves or aortic valves, "upper" and "lower" are distinguished in the axial direction according to the actual placement orientation or the orientation shown in the diagram.

[0041] It is worth noting that the terms indicating orientation or positional relationship mentioned above are only for the convenience of describing the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

[0042] It is also worth noting that some components in this invention (such as docking devices, valve prostheses, etc.) have a contracted state suitable for the delivery or deployment process, as well as an expanded state in a free state or after deployment. Unless otherwise specified, the structural descriptions below are made in the expanded state of each component.

[0043] Please see Figure 1 and Figure 2 An embodiment of the present invention provides a valve replacement system, including a docking device 10, an anchoring device 30, and a valve prosthesis 60. The docking device 10 is configured to be positioned by the anchoring device 30 and provides a receiving cavity 11; the anchoring device 30 includes a plurality of anchoring elements 31, a plurality of locking elements 33 in the same number as the plurality of anchoring elements 31, and a plurality of flexible linear elements 35 in the same number as the plurality of anchoring elements 31.

[0044] exist Figure 1 and Figure 2 In the completed deployment state shown: one end of the linear component 35 is fixedly connected to an anchor 31, and the other end penetrates the docking device 10 and is fixedly connected to a locking component 33; at least one anchor 31 is anchored into the ventricular tissue for fixation, and at least another anchor 31 is anchored into the valve annulus tissue or atrial tissue for fixation; the linear component 35 is tensioned by the corresponding anchor 31 and locking component 33 located on opposite sides of the docking device 10, so that the docking device 10 is pressed against the original valve annulus for positioning; the valve prosthesis 60 is inserted into the receiving cavity 11 of the docking device 10 and positioned by the docking device 10, and the positioning method includes, but is not limited to, interference fit, snap-fit, etc.

[0045] The aforementioned valve replacement system is suitable for replacing native diseased atrioventricular valves, including native mitral and tricuspid valves. When replacing a native mitral valve, it can be called a mitral valve replacement system, with the docking device 10 positioned against the native mitral valve annulus. When replacing a native tricuspid valve, it is as follows: Figure 1 and Figure 2 An example, which could be called a tricuspid valve replacement system, is that the docking device 10 is positioned against the original tricuspid valve annulus.

[0046] Although the mitral or tricuspid valves have unique physiological and anatomical structures and complex physiological environments below the valve annulus, this invention differs from existing technologies by not relying on anchors, barbs, or clamps on the valve prosthesis that act on the native leaflet and / or native valve annulus for positioning. Instead, the valve prosthesis 60 is positioned by the docking device 10, which is further positioned by the anchoring device 30. At least one anchor 31 in the anchoring device 30 is anchored into the ventricular tissue, and at least another anchor 31 is anchored into the valve annulus tissue or atrial tissue. The linear member 35 is tensioned by the corresponding anchors 31 and locking members 33 located on opposite sides of the docking device 10. By using the physical means of the tensioned linear member 35 pulling the locking member 33, the docking device 10 can be firmly pressed against the native valve annulus for positioning, thereby reliably fixing the valve prosthesis 60 by the docking device.

[0047] The docking device, anchoring device, and valve prosthesis in some embodiments of the present invention will be described in sequence below with reference to the accompanying drawings. It is understood that different embodiments of the docking device, different embodiments of the anchoring device, and valve prostheses can be combined in various ways to form the entire valve replacement system.

[0048] docking device

[0049] Please see Figures 3 to 6 Combination Figure 1 and Figure 2 In one embodiment, the docking device 10 includes a frame 13 and a membrane 15 covering the frame 13. The docking device 10 can be divided into a cavity section 12 and a disk section 14. The frame 13 correspondingly includes a cavity frame 132 and a disk frame 134. The membrane 15 includes a cavity membrane 152 covering the cavity frame 132 and a disk membrane 154 covering the disk frame 134. The cavity frame 132 is generally cylindrical in shape extending axially to enclose the accommodating cavity 11. The disk frame 134 connects to the cavity frame 132 and extends radially outward relative to the cavity frame 132.

[0050] In this embodiment, the cavity frame 132 includes an inner frame 1321 and an outer frame 1323. The inner frame 1321 and the outer frame 1323 are formed and then fixedly connected together. The fixing connection method includes, but is not limited to, welding and binding. The outer frame 1323 abuts against the radially outer side of the inner frame 1321, and the upper end of the outer frame 1323 integrally extends out of the disc frame 134. The inner frame 1321 surrounds the receiving cavity 11. In order to ensure that the receiving cavity 11 has sufficient axial length to accommodate the valve prosthesis 60, the axial length of the inner frame 1321 is greater than the axial length of the outer frame 1323. Preferably, the upper end of the inner frame 1321 can axially protrude from the upper end of the disc frame 134. It can be understood that the docking device 10 can be placed at the original mitral valve as part of the mitral valve replacement system, or it can be placed at the original tricuspid valve as part of the tricuspid valve replacement system. The above-mentioned "upper end" corresponds to the inflow end and "lower end" corresponds to the outflow end.

[0051] In this embodiment, the inner frame 1321 can be formed by braiding and heat-setting biocompatible and shape-memory metal wires, such as nickel-titanium alloy wires, and then fixing the ends of the nickel-titanium alloy wires together with steel sleeves. Further, the inner frame 1321 includes several interconnected, generally U-shaped first units A1 to allow the inner frame 1321 to be radially compressed for easy delivery. The axial height of the inner frame 1321 can be greater than or equal to 3 mm, the diameter of the accommodating cavity 11 enclosed by the inner frame 1321 can be in the range of 18 mm to 40 mm, and the wire diameter of the nickel-titanium alloy wire can be in the range of 0.1 mm to 1 mm. In a preferred example, the axial height of the inner frame 1321 is 15 mm, the diameter of the accommodating cavity 11 is 27 mm, and the wire diameter of the nickel-titanium alloy wire is 0.4 mm.

[0052] Figure 7a , Figure 7b , Figure 7c Different structural forms of the internal frame are shown. Figure 7a The inner frame 2321 shown is made of biocompatible and shape memory nickel-titanium alloy tubing through cutting and heat setting, including multiple interconnected first units A12 in a generally rhomboid grid to allow the inner frame 2321 to be radially compressed for easy delivery. Figure 7b The inner frame 3321 shown is made of biocompatible and shape memory nickel-titanium alloy tubing through cutting and heat setting, including multiple interconnected hexagonal grid-shaped first units A13 to allow the inner frame 3321 to be radially compressed for easy delivery. Figure 7cThe inner frame 4321 shown is made of biocompatible and shape-memory nickel-titanium alloy tubing, cut and heat-set. It includes a first unit A14, such as three interconnected, generally V-shaped strips, to allow the inner frame 4321 to be radially compressed for easy delivery. The width and thickness of each support bar in the grid or strip can be in the range of 0.1mm-1mm.

[0053] like Figure 8a As shown, combined with Figure 5 and Figure 6 In this embodiment, the outer frame 1323 and the disk frame 134 integrally connected thereto are made of shape-memory metal wire, such as nickel-titanium alloy wire, through weaving and heat setting. The outer frame 1323 includes multiple U-shaped units, and the disk frame 134 includes multiple interconnected and circumferentially arranged second units A2, each formed by several wire supports, with adjacent second units A2 spaced apart circumferentially. Each second unit A2 extends radially outward relative to the outer frame 1323. The axial height of the outer frame 1323 is greater than or equal to 1 mm, and the maximum diameter of the disk frame 134 is in the range of 40 mm to 80 mm.

[0054] Preferably, the radial profile of the second unit A2 is generally a transverse S-shape, including a first segment 1341, a second segment 1343, and a third segment 1345 connected in sequence; the first segment 1341 is connected to the outer frame 1323, and while extending radially outward, the first segment 1341 first extends upward and then downward in the axial direction; the second segment 1343 extends radially outward, and first extends downward and then upward in the axial direction; the third segment 1345 extends radially outward and continues to extend upward in the axial direction. The beneficial effect of this design is that when the second unit A2 of the disc section 14 abuts against the valve annulus tissue and the atrial tissue, the area where the lowest axial point of the second segment 1343 is located can be subjected to downward forces from the first segment 1341 and the third segment 1345 on both sides, thereby pressing more tightly against the valve annulus tissue and improving the effect of preventing paravalvular leakage. The third segment 1345 is subjected to the reaction force from the second segment 1343 and fits more tightly against the atrial tissue, which can also improve the effect of preventing paravalvular leakage.

[0055] Figure 8bExamples of different structural forms of the outer frame and the disk frame 2323 are shown. The outer frame 2323 and the disk frame 234 are made of nickel-titanium alloy tubing with biocompatibility and shape memory function through cutting and heat setting. The outer frame 2323 and the disk frame 234 each include multiple interconnected grids. The disk frame 234 also includes multiple interconnected second units A22 arranged circumferentially, each second unit A22 extending radially outward relative to the outer frame 2323. Preferably, the radial profile of the second unit A22 is generally a transverse S-shape, including a first segment 2341, a second segment 2343, and a third segment 2345 connected in sequence; the first segment 2341 is connected to the outer frame 2323, and while extending radially outward, the first segment 2341 first extends upward and then downward in the axial direction; the second segment 2343 extends radially outward, and first extends downward and then upward in the axial direction; the third segment 2345 extends radially outward and continues to extend upward in the axial direction.

[0056] Please refer to it again. Figures 3 to 5 The cavity membrane 152 can be sewn onto the inner and / or outer surfaces of the cavity skeleton 132 to form the cavity segment 12; the disc membrane 154 can be sewn onto the inner and / or outer surfaces of the disc skeleton 134 to form the disc segment 14. The cavity membrane 152 and the disc membrane 154, especially the disc membrane 154, are made of tough, tear-resistant materials such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polypropylene (PP), polyethylene (PE), and other synthetic or natural materials. It is understood that the cavity membrane 152 and the disc membrane 154 can be integral or separate, connected together by sewing.

[0057] Combination Figure 1 , Figure 2 The disc section 14 has a number of wire holes 141, the number of which is the same as the number of linear members 35. Each wire hole 141 allows a corresponding linear member 35 to pass through. The wire holes 141 are located radially closer to the cavity 11 and farther away from the free end of the disc section 14, so that the locking member 33 has a more stable point of force after locking the 35.

[0058] As previously mentioned, the docking device 10 can be configured at the native mitral valve or the native tricuspid valve.

[0059] The docking device 10, suitable for placement at the native mitral valve, should at least have its disc section 14 positioned above the native mitral valve annulus. The outer periphery of the disc section 14 can be a regular circle, preferably a D-shape or saddle shape that better matches the physiological anatomy of the mitral valve annulus to improve paravalvular leakage prevention. A portion of the cavity section 12 may be located within the native mitral valve annulus, but preferably, the axial length of this portion is small or minimal, to the extent that it does not significantly affect the opening and closing of the native mitral valve leaflets. It is understood that in other embodiments, the docking device is generally disc-shaped, in which case both the disc section and the cavity section can be positioned above the native mitral valve annulus without affecting the opening and closing of the native mitral valve leaflets. The necessity and benefit of this setup is that the valve prosthesis 60 can only be delivered and deployed after the docking device 10 has been deployed. This process takes a long time. Since the docking device 10 does not significantly affect the opening and closing of the native mitral valve leaflets, the blood circulation from the left atrium to the left ventricle of the patient can proceed normally, thus allowing the operator ample time to deliver and deploy the mitral valve prosthesis.

[0060] For a docking device 10 suitable for placement at the native tricuspid valve, at least its disc segment 14 should be configured above the native tricuspid valve annulus. A portion of the cavity segment 12 may lie within the native tricuspid valve annulus, but preferably this portion has a small or minimal axial length, limited to the point of not significantly affecting the opening and closing of the native tricuspid valve leaflets. It is understood that in other embodiments, the docking device is generally disc-shaped, in which case both the disc segment and the cavity segment can be located above the native tricuspid valve annulus without affecting the opening and closing of the native tricuspid valve leaflets. The necessity and benefit of this arrangement is that the valve prosthesis 60 can only be delivered and deployed after the docking device 10 has been deployed, a process that takes time. Since the docking device 10 does not significantly affect the opening and closing of the native tricuspid valve leaflets, blood circulation from the right atrium to the right ventricle can proceed normally, thus allowing the operator ample time to perform the delivery and deployment of the tricuspid valve prosthesis.

[0061] Since the atrioventricular node is located at the septal apex of the native tricuspid valve, the anterior medial border of the coronary sinus ostium of the right atrium, and the deep endocardial surface of the Koch triangle between the Todaro tendon, a more specialized structural design is required for the docking device 10, which is suitable for placement at the native tricuspid valve, in order to avoid affecting the atrioventricular node in the radial and / or axial directions, thereby reducing or avoiding the occurrence of atrioventricular block and reducing or avoiding pacemaker implantation.

[0062] First, the docking device 10 is configured to avoid dilating the native tricuspid valve annulus; that is, none of the parts of the docking device 10 can dilate the native tricuspid valve annulus. The disc section 14, being positioned above the native tricuspid valve annulus, avoids dilating it. The outer diameter of the cavity section 12 is set smaller than the inner diameter of the native tricuspid valve annulus to avoid dilating it. Ensuring that none of the parts of the docking device 10 dilate the native tricuspid valve annulus ensures that the docking device 10 will not exert radial pressure on the atrioventricular node.

[0063] More importantly, the docking device 10 has a clearance portion 143 on the disk section 14 to reduce axial pressure on the atrioventricular node or to avoid the atrioventricular node. The area of ​​the clearance portion 143 should be able to encompass the Koch triangle.

[0064] In this embodiment, the disc section 14 is provided with an axially perforated recess 143. The area of ​​the disc skeleton 134 corresponding to the recess 143 is exposed outside the disc cover 154, or in other words, the area of ​​the disc skeleton 134 corresponding to the recess 143 is not covered, and the second unit A2 in this area is axially perforated. The second units A2 in this area are spaced apart from each other in the circumferential direction and are not connected into a whole by the disc cover 154. Therefore, when the docking device 10 is positioned against the original tricuspid valve annulus, the axial squeezing force exerted on the tricuspid valve annulus by the area where the recess 143 is located is significantly reduced compared to other areas of the disc section 14. Thus, the recess 143 reduces the axial compression on the atrioventricular node.

[0065] With the hollowed-out clearance portion 143 provided, the outer periphery of the disc section 14, i.e. the outer periphery of the disc skeleton 134, can be, but is not limited to, circular or near-circular; of course, the outer periphery of the disc section 14 can also be set as a non-circular shape that matches the physiological and anatomical structure of the tricuspid valve annulus.

[0066] Furthermore, if Figure 1 , Figure 2 After the valve replacement system shown is deployed (either immediately or after some time), if the patient develops symptoms such as arrhythmia or bradycardia, and atrioventricular block reaches grade II type II or III (the cause may be the implantation of the valve replacement system or other cardiac diseases), a pacemaker will need to be implanted. To prepare for pacemaker implantation in advance, see [link to relevant documentation]. Figure 3 , Figure 4 , combined Figure 32The docking device 10 also has a position marker 145 on the disc section 14 for the pacing lead 80 to puncture. The pacing lead 80 penetrates the disc section 14 at the position marker 145 to enter the right ventricle. Specifically, the position marker 145 is fixed to the disc cover 154 and is made of radiopaque material to indicate the alignment of the pacing lead 80. The position marker 145 is located radially inside the avoidance portion 143, preferably radially inside the threading hole 141, so that the pacing lead 80 can pass between the original leaflet and the ventricle skeleton after penetrating the disc section 14 at the position marker 145 (i.e., through the cover at that point and the mesh of the disc skeleton below that point). This arrangement avoids the pacing lead 80 passing between the artificial leaflets 65 of the valve prosthesis 60, ensuring the normal movement of the artificial leaflets 65 and the normal function of the valve prosthesis 60.

[0067] Understandably, in the docking device embodiments described above, the inner frame can be omitted, and only the outer frame and the disc skeleton can be retained to form an integrated docking device, which can help reduce the radial compression size of the entire docking device. However, it is necessary to ensure that the outer frame can generate sufficient radial restraint force on the valve prosthesis located in its accommodating cavity.

[0068] Figure 9 A second embodiment of the docking device is shown. This second embodiment differs from the previous embodiment in that the outer periphery of the disk section 214 of the docking device 210 is not a regular circle, but includes a superior arc segment 2146. The outer periphery has a gap area compared to the complete circle containing the superior arc segment 2146. This gap area has neither a coating nor a disk frame, and this gap area constitutes a clearance portion 2143. (In conjunction with...) Figure 10 As shown, the disk skeleton 2134 is formed by weaving and heat setting metal wires (such as nickel-titanium alloy wires) with shape memory function, and its outer perimeter contour (that is, the outer perimeter contour of the disk section) corresponds to the area missing of the clearance portion 2143. Of course, the area of ​​the clearance portion 2143 should at least be able to encompass the Koch triangle.

[0069] Figure 11 A third embodiment of the docking device is shown, which differs from the second embodiment described above in that the outer periphery of the disk section 314 of the docking device 310 has a more irregular shape, and the area of ​​the vacant region serving as the clearance portion 3143 is larger. Combined with... Figure 12 As shown, the disk skeleton 3134 is formed by cutting and heat-setting tubing with shape memory function (such as nickel-titanium alloy tubing).

[0070] In the second and third embodiments described above, the avoidance portion is a vacant area that completely avoids the atrioventricular node. Therefore, it will not compress the atrioventricular node in the axial direction, and can more effectively avoid the occurrence of conduction block.

[0071] Figures 13 to 15 The fourth embodiment of the docking device shows a skeleton 413, which includes an integrally formed cavity skeleton 4132 and a disk skeleton 4134. Optionally, the skeleton 413 is formed by weaving and heat setting metal wires (such as nickel-titanium alloy wire) with shape memory function. The cavity skeleton 4132 includes multiple inverted U-shaped first units A15 arranged circumferentially, and the disk skeleton 4134 includes multiple circumferentially arranged second units A25. Adjacent second units A25 have overlapping portions and are interwoven. A second unit A25 extends from the outlet end of a first unit A15, and the corresponding first unit A15 and second unit A25 form a support rod that encloses a closed space. The radial profile of the second unit A25 is also generally transversely S-shaped, comprising a first segment 4341, a second segment 4343, and a third segment 4345 connected in sequence. The first segment 4341 extends radially outward from the outflow end of the first unit A15. The second segment 4343 first extends axially upward and then continues to extend radially outward. The third segment 4345 continues to extend radially outward while also extending axially upward. The axially upward section of the second segment 4343 can be positioned within the native valve annulus, but without dilating the native valve annulus. The third segment 4345 is positioned to press against the native valve annulus tissue and / or atrial tissue.

[0072] This structural design of the skeleton 413 allows the disc skeleton 4134 to extend axially below the cavity skeleton 4132 when it is compressed to the delivery state, and the disc skeleton 4134 and the cavity skeleton 4132 do not overlap radially, thereby helping to reduce the radial compression size of the entire docking device.

[0073] As is understood, similar to the aforementioned embodiments of the docking device, the skeleton 413 of the docking device in this embodiment is covered with a membrane (not shown in the figure), and the disk section is provided with structural features such as threading holes, avoidance parts, and position marking points (not shown in the figure), which will not be described again here.

[0074] Anchor Locking Device

[0075] Please see Figures 16 to 19 In one embodiment, the anchoring device 30 for positioning the docking device 10 includes a plurality of anchoring elements 31, a plurality of locking elements 33 in the same number as the plurality of anchoring elements 31, and a plurality of flexible linear elements 35 in the same number as the plurality of anchoring elements 31.

[0076] In one example, the anchor 31 includes a pin seat 311 and a helical pin body 313 connected to the pin seat 311, wherein the pin seat 311 is fixedly connected to one end of the linear member 35. The pin seat 311 may be configured as cylindrical or cylindrical, and one end of the linear member 35 may be fixedly connected to the pin seat 311 by crimping. One end of the helical pin body 313 is fixedly connected to the pin seat 311, and the other end is a sharp tip to facilitate anchoring into the tissue. The pin seat 311 and the helical pin body 313 may be made of, but are not limited to, cobalt-chromium alloy, stainless steel, etc.

[0077] It is understandable that the anchoring element can also adopt other structural forms, such as the anchor disclosed in the earlier patent application CN113040978A filed by the applicant of this invention, as long as it can be anchored into the tissue and can still be stably positioned in the tissue when pulled by the linear element.

[0078] The locking element 33 includes a spindle 331, a first end cap 333 fixedly disposed at the distal end of the spindle 331, a second end cap 335 selectively movably disposed on the spindle 331 and axially spaced from the first end cap 333, and a spring 337 sleeved on the spindle 331 between the first end cap 333 and the second end cap 335. The materials of the spindle 331, the first end cap 333, and the second end cap 335 may be, but are not limited to, cobalt-chromium alloy, stainless steel, etc., while the spring 337 is selected from a biocompatible and corrosion-resistant material suitable for making springs. The second end cap 335 can be selectively and movably mounted on the spindle 331 in ways including but not limited to screw connection (e.g., the spindle 331 has an external thread, and the second end cap 335 has a matching internal thread) and snap connection (e.g., the spindle 331 has an elastic locking block, and the second end cap 335 has a locking groove; when the elastic locking block enters the locking groove, the second end cap 335 can no longer move axially). After the second end cap 335 moves (rotates or moves axially) toward the first end cap 333 to a predetermined position, it can be positioned at that predetermined position.

[0079] The linear element 35 is arranged in an approximately wave-like pattern on each coil of the spring 337, with adjacent crests and troughs located radially inside and radially outside of adjacent coils, respectively. When the second end cap 335 moves toward the first end cap 333 and is positioned at a predetermined position, it can compress the spring 337 to clamp the linear element 35 between adjacent coils.

[0080] It is understandable that the locking element can also adopt other structural forms, such as the locking pins disclosed in the earlier patents CN110575210A and CN116269559A filed by the applicant of this invention, as long as it can lock the linear element.

[0081] The linear component 35 can be made of medical sutures.

[0082] Combination Figures 24 to 29 In the anchoring device 30, the anchoring element 31 is deployed before the docking device 10. Before the docking device 10 is deployed, one end of the linear element 35 is fixedly connected to an anchoring element 31 that anchors into the ventricular tissue, valve annulus tissue, or atrial tissue, while the other end extends outside the body. During the deployment of the docking device 10, the extended end of each linear element 35 passes through the threading hole 141, and the linear element 35 guides the docking device 10 to the original atrioventricular valve. Then, each locking element 33 is threaded onto the corresponding linear element 35, and the linear element 35 guides the locking element 35 to be delivered to the vicinity of the disc section 14 of the docking device 10. Next, by controlling the tension of the locking element 33 on the linear element 35, so that the disc section 14 can be tightly attached to the original valve annulus tissue and / or atrial tissue, the locking element 33 is operated to lock the linear element 35.

[0083] To remove the portion of the linear member 35 extending outside the body proximal to the locking member 33, the valve replacement system should also include a shearing device or a locking-cutting integrated device for cutting off the portion of the linear member 35 proximal to the locking member 33 after the linear member 35 is fixedly connected to the locking member 33. The shearing device or locking-cutting integrated device can be found in the earlier patent applications of the applicant, CN116269559A, CN114617591A, CN113491547A, etc.

[0084] With the docking device 10 and the anchoring device 30 deployed: one end of the linear component 35 is fixedly connected to an anchoring component 31, and the other end penetrates the wire hole 141 of the disc section 14 and is fixedly connected to a locking component 33.

[0085] Combination Figure 1 and Figure 2 In the case of a tricuspid valve replacement system, the disc segment 14 is configured to lie on the original tricuspid valve annulus. At least one anchor 31 is anchored into the right ventricular tissue, including but not limited to the right ventricular wall, tricuspid valve papillary muscles, and interventricular septum, and at least another anchor 31 is anchored into the tricuspid valve annulus tissue or right atrial tissue. Preferably, at least one anchor 31 is anchored into the interventricular septum, at least another anchor 31 is anchored into the annulus tissue corresponding to the original anterior leaflet or the atrial tissue adjacent to the original anterior leaflet, and at least a third anchor 31 is anchored into the annulus tissue corresponding to the original posterior leaflet or the atrial tissue adjacent to the original posterior leaflet. The linear member 35 is tensioned by the anchors 33 and locking members 33 located on opposite sides of the disc segment 14, so that the docking device 10 is positioned against the tricuspid valve annulus. This arrangement helps to ensure that the anchoring device 30 is positioned more symmetrically and evenly on the docking device 10 without damaging the atrioventricular node.

[0086] Understandably, in the case of a mitral valve replacement system (not shown in the figure), the disc segment is configured to lie above the native mitral valve annulus, with at least one anchor anchored into the left ventricular tissue, including but not limited to the left ventricular wall, papillary muscles, and interventricular septum, and at least another anchor anchored into the mitral valve annulus tissue or left atrial tissue; or, all anchors are anchored into the mitral valve annulus tissue or left atrial tissue. The linear element is tensioned by the corresponding anchors and locking elements located on opposite sides of the disc segment, causing the docking device to be positioned against the mitral valve annulus.

[0087] valve prosthesis

[0088] Please see Figure 20 and Figure 21 The valve prosthesis 60 of the present invention includes a valve frame 61, a membrane 63 covering the valve frame 61, and at least two artificial leaflets 65 that can be opened and closed relative to each other, wherein the artificial leaflets 65 are fixedly connected to the valve frame 61 and / or the membrane 63.

[0089] The valve frame 61 includes a valve frame body 62 and a plurality of loading members 64 connected to the valve frame body 62; the loading member 64 includes a first loading section 641 and a second loading section 643, wherein the first loading section 641 is provided with a first loading portion 642, and the second loading section 643 is provided with a second loading portion 644, wherein the first loading portion 642 is configured to protrude axially from a first end 621 of the valve frame body 62 and can be loaded by a valve delivery device (not shown), and the second loading portion 644 is configured to protrude axially from a second end 623 of the valve frame body 62 opposite to the first end 621 and can be loaded by a valve delivery device.

[0090] The valve frame body 62 is an expandable frame component that supports the artificial valve leaflet 65. The valve prosthesis 60 can be radially compressed to a compressed state for delivery to a predetermined deployment site, such as the aortic valve, or the aforementioned pre-deployed docking device 10, forming a valve replacement system together with the docking device 10 and the anchoring device 30 to replace the native tricuspid valve (e.g., Figure 1 (as shown) or the original mitral valve; the valve prosthesis 60 can also expand or inflate at the deployment site to the size shown. Figure 20 and Figure 21 The functional dimensions are shown in the deployed state. In a particular embodiment, the valve prosthesis 60 is self-expanding, and its valve frame body 62 is made of a metal with shape memory function, such as a nickel-titanium alloy; in other embodiments, the valve prosthesis 60 can also be balloon-expanded, and its valve frame body 62 can be made of a cobalt-chromium alloy.

[0091] Artificial leaflets 65 can be made from any suitable biological material (e.g., pericardial tissue, such as bovine or porcine pericardium), biocompatible synthetic material, or other such material.

[0092] Membrane 63 may include biocompatible flexible compressible materials, such as PET fabrics, pericardial tissue, etc.

[0093] Specifically, in Figure 20 and Figure 21 In the illustrated embodiment, the petiole frame body 62 includes a first segment Q1 adjacent to the first end 621, a second segment Q2 adjacent to the second end 623, and an intermediate segment Q3 connecting the first segment Q1 and the second segment Q2. The first segment Q1 includes a first mesh G1, the second segment Q2 includes a second mesh G2, and the intermediate segment Q3 includes at least one, such as two or three, intermediate meshes G3. The shape of each mesh layer can be, but is not limited to, rhombus, hexagon, etc. The first loading segment 641 is fixedly connected to the free end of the first mesh G1 away from the intermediate mesh G3, and the second loading segment 643 is fixedly connected to the free end of the second mesh G2 away from the intermediate mesh G3. The fixed connection method can be, but is not limited to, welding, integral extension, etc.

[0094] When the valve prosthesis 60, docking device 10, and anchoring device 30 together form a valve replacement system to replace the native tricuspid or native mitral valve, the intermediate section Q3 is interference-fitted into the receiving cavity 11 of the docking device 10, and preferably the intermediate section Q3 is radially concave inward relative to the first section Q1 and the second section Q2, so that the first section Q1 and the second section Q2 can further restrict the axial displacement of the valve prosthesis 60 on both sides of the receiving cavity 11.

[0095] At least three first loading segments 641 are provided, which can be evenly arranged circumferentially. The axial lengths of the three first loading segments 641 can be the same, but preferably at least one first loading segment 641 has an axial length different from the other first loading segments 641, and more preferably the lengths are different. The beneficial effect of this arrangement is that when the first loading segments 641 are used to load the valve prosthesis 60, it is convenient to load them in sequence, first loading the ones with longer axial lengths, then loading the ones with intermediate axial lengths, and finally loading the ones with the shortest axial lengths. On the other hand, when releasing the valve prosthesis 60, it is also convenient to release it in sequence, first releasing the ones with shorter axial lengths, then releasing the ones with intermediate axial lengths, and finally releasing the ones with the longest axial lengths. This can prevent the jumping caused by the instantaneous complete release of the valve prosthesis 60, and improve the stability and accuracy of the release.

[0096] Similarly, at least three second loading segments 643 are provided. These three second loading segments 643 can be evenly arranged circumferentially. Each second loading segment 643 can be aligned circumferentially with the corresponding first loading segment 641 or staggered from each other. The axial lengths of the three second loading segments 643 can be the same, but preferably at least one second loading segment 643 has an axial length different from the other second loading segments 643, and more preferably, the lengths are different. The beneficial effect of this arrangement is that when the second loading segments 643 are used to load the valve prosthesis 60, on the one hand, it is convenient to load them in sequence, first loading the ones with longer axial lengths, then loading the ones with intermediate axial lengths, and finally loading the ones with the shortest axial lengths. On the other hand, when releasing the valve prosthesis 60, it is also convenient to release it in sequence, first releasing the ones with shorter axial lengths, then releasing the ones with intermediate axial lengths, and finally releasing the ones with the longest axial lengths. This can prevent the jumping caused by the instantaneous complete release of the valve prosthesis 60 and improve the stability and accuracy of the release.

[0097] Figures 22a to 22d Optional structures for the first loading section 642 or the second loading section 644 are shown respectively. For example, the first loading section 642 or the second loading section 644 may be... Figure 22a The circular protrusion shown, such as Figure 22b The semi-circular convex piece shown, such as Figure 22c The elliptical hole shown, as Figure 22d The circular holes shown are formed on the circular protrusions. A groove or protrusion of a suitable shape is provided at the distal end of the valve delivery device for connection and loading.

[0098] Preferably, at least one first loading segment 641 is radially inward relative to the first grid G1, and / or at least one second loading segment 643 is radially inward relative to the second grid G2. This arrangement facilitates the smooth loading of the respective loading segments into the sheath.

[0099] Compared with the prior art, the valve prosthesis 60 of the present invention has a first loading portion 642 configured to protrude axially from the first end 621 of the valve frame body 62 and be loaded by a valve delivery device, and a second loading portion 644 configured to protrude axially from the second end 623 of the valve frame body 62 and be loaded by a valve delivery device.

[0100] For the same primary diseased valve, the valve prosthesis 60 can be connected to and mounted on a valve delivery device using the first loading portion 642, suitable for either a transcatheter or transapical interventional approach, or it can be connected to and mounted on a valve delivery device using the second loading portion 644, suitable for either a transcatheter or transapical interventional approach. For example, for the primary aortic valve, the valve prosthesis 60 can be connected to and mounted on a valve delivery device using the first loading portion 642, suitable for a transcatheter interventional approach to replace the primary aortic valve (see reference). Figure 23(as shown); Alternatively, the second loading unit 644 can be connected to and loaded onto the valve delivery device, suitable for transapical interventional approaches to replace the native aortic valve (see reference). Figure 23 (As shown). For example, for the native tricuspid valve, the valve prosthesis 60 can be connected to and mounted on a valve delivery device using the second loading portion 644, suitable for transcatheter interventional approaches to replace the native tricuspid valve (see reference). Figure 1 (as shown); the first loading unit 642 can also be connected to and loaded onto a valve delivery device, suitable for transapical interventional approaches to replace the native tricuspid valve (see reference). Figure 1 (As shown).

[0101] For the same transcatheter interventional approach, the valve prosthesis 60 can be connected to and mounted on the valve delivery device using the first loading part 642, and deployed independently in a first position to replace the native aortic valve (see reference). Figure 23 (as shown); Alternatively, a second loading unit 644 can be connected to and loaded onto the valve delivery device, positioned in a second orientation inverted relative to the first orientation, and deployed together with the docking device 10 and the anchoring device 30 to replace the native atrioventricular valve, including the native tricuspid valve (see reference). Figure 1 (as shown), or the native mitral valve. For the transapical homologous interventional approach, the valve prosthesis 60 can be connected to and mounted on the valve delivery device using the second loading unit 644, and deployed independently in the first position to replace the native aortic valve (see...). Figure 23 (as shown); Alternatively, the first loading part 642 can be connected to and loaded onto the valve delivery device, positioned in a second orientation inverted from the first orientation, and deployed together with the docking device 10 and the anchoring device 30 to replace the native atrioventricular valve, including the native tricuspid valve (see reference). Figure 1 (as shown), or the native mitral valve.

[0102] As can be seen from the above, the valve prosthesis 60 of the present invention can be loaded in both directions, significantly broadening its applicable scope.

[0103] Deployment process of valve replacement system

[0104] The following describes the deployment process of the valve replacement system of the present invention, taking the replacement of the original diseased tricuspid valve as an example, in the order of operation.

[0105] Step 1:

[0106] Please see Figure 24 and Figure 25The first delivery device 91 delivers and deploys several anchors 31 one by one via the superior vena cava. At least one or two anchors 31 are anchored into the interventricular septum tissue, at least another anchor 31 is anchored into the valve annulus tissue corresponding to the original anterior leaflet or the atrial tissue adjacent to the original anterior leaflet, and at least another anchor 31 is anchored into the valve annulus tissue corresponding to the original posterior leaflet or the atrial tissue adjacent to the original posterior leaflet. The free ends of the linear members 35 that are fixedly connected to each anchor 31 extend outside the body.

[0107] Step 2:

[0108] Please see Figure 26 and Figure 27 After the free ends of each linear component 35 extending outside the body pass through the corresponding thread holes 141 of the docking device 10, the docking device 10 is compressed and loaded into the second delivery device 93. The second delivery device 93 then delivers and deploys the docking device 10 along the guide of the linear component 35 at the native tricuspid valve. After the docking device 10 is deployed, its disc section 14 can approach the native tricuspid valve annulus tissue and / or tricuspid valve atrial tissue, while the avoidance portion 143 avoids Koch's triangle.

[0109] Step 3:

[0110] Please see Figure 28 and Figure 29 The free ends of each linear component 35 extending outside the body are respectively inserted into each locking component 33. The third delivery device 95 delivers and locks the locking components 33 one by one. During this process, the tightness between the disc section 14 and the original tricuspid valve annulus tissue and / or tricuspid valve atrial tissue can be adjusted by controlling the tension of the locking component 33 on the linear component 35, in order to seek a better paravalvular leakage prevention effect. After the adjustment is completed, the locking component 33 is locked to the linear component 35, so that the docking device 10 is pressed against the original tricuspid valve annulus for positioning.

[0111] Then, the portion of the linear member 35 located near the locking member 33 is cut off using a cutting device.

[0112] Step 4:

[0113] Please see Figure 30 The valve prosthesis 60 is delivered and deployed into the receiving cavity 11 of the docking device 10 via a catheter using a valve delivery device (not shown) through the superior vena cava. Specifically, the valve prosthesis 60 is connected to and loaded into the valve delivery device via a second loading part 644.

[0114] This completes the deployment of the entire valve replacement system.

[0115] Understandably, after step 3 delivers the locking member 33 to the disc section 14 of the docking device 10 and maintains contact, the valve prosthesis 60 can be delivered and deployed first. Then, by controlling the tension of the locking member 33 on the linear member 35, the tightness between the disc section 14 and the original tricuspid valve annulus tissue and / or tricuspid valve atrial tissue can be adjusted to seek the ideal paravalvular leakage prevention effect. After the adjustment is completed, the locking member 33 is then locked to the linear member 35.

[0116] Understandably, valve replacement systems can also be used to replace the native mitral valve, as long as a suitable interventional route is chosen, such as via the inferior vena cava—atrial septum—left atrium. Since the deployment steps are essentially the same, they will not be repeated here.

[0117] Furthermore, such as Figure 31 As shown, the valve replacement system may further include several auxiliary anchors 97. Each auxiliary anchor 97 is delivered one by one by a corresponding delivery device (not shown) and passes directly through the area adjacent to the outer peripheral contour of the disc segment 14 of the docking device 10 and anchors into the annular tissue and / or atrial tissue, so that the disc segment 14 can adhere more tightly to the annular tissue and / or atrial tissue, further improving the paravalvular leakage prevention effect. The specific structure of the auxiliary anchor 97 can be found in the relevant description of the anchor 31, but the auxiliary anchor 97 does not need to be connected to the linear component.

[0118] Understandably, the auxiliary anchor 97 is only set when there is a need. If the anti-leaking effect is already satisfactory, then there is no need to set it.

[0119] Furthermore, such as Figure 32 As shown, after the valve replacement system is deployed (either immediately or after some time), if the patient experiences symptoms such as arrhythmia or bradycardia, and atrioventricular block reaches type II or III (the cause may be the implantation of the valve replacement system or other heart diseases), a pacemaker is implanted, and the pacing lead 80 penetrates the disc segment 14 at the location marker 145 to enter the right ventricle.

[0120] Understandably, pacemaker implantation is not necessary; if there are no relevant indications, then implantation is not required.

[0121] The above description is only a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the embodiments listed above. Any simple changes or equivalent substitutions of the technical solutions that can be obviously obtained by those skilled in the art within the scope of the technology disclosed in the present invention shall fall within the scope of protection of the present invention.

Claims

1. A valve replacement system for replacing a native atrioventricular valve, characterized in that, Includes docking device, anchoring device and valve prosthesis; The docking device is configured to be positioned by the anchoring device and to provide a receiving cavity; The anchoring device includes several anchoring elements, several locking elements of the same number as the anchoring elements, and several flexible linear elements of the same number as the anchoring elements; In the deployed state: one end of the linear component is fixedly connected to an anchoring component, and the other end penetrates the docking device and is fixedly connected to a locking component; at least one anchoring component is anchored into ventricular tissue, and at least another anchoring component is anchored into valve annulus tissue or atrial tissue; the linear component is tensioned by the anchoring components and locking components located on opposite sides of the docking device, so that the docking device is pressed against the original valve annulus for positioning; the valve prosthesis is inserted into the receiving cavity of the docking device and positioned by the docking device.

2. The valve replacement system as described in claim 1, characterized in that, The docking device is configured to eliminate the need for dilation of the original valve annulus, and the valve prosthesis is interference-fitted into the receiving cavity of the docking device.

3. The valve replacement system as described in claim 1, characterized in that, The docking device includes a skeleton and a membrane covering the skeleton; wherein the skeleton is composed of biocompatible metal wires and / or metal mesh.

4. The valve replacement system as described in claim 3, characterized in that, The docking device includes a cavity section and a disk section, and the skeleton correspondingly includes a cavity skeleton and a disk skeleton. The membrane includes a cavity membrane covering the cavity skeleton and a disk membrane covering the disk skeleton. The cavity skeleton is generally cylindrical in shape extending axially to enclose the accommodating cavity. The disk skeleton is connected to the cavity skeleton and extends radially outward relative to the cavity skeleton.

5. The valve replacement system as described in claim 4, characterized in that, The disc section is equipped with a clearance section.

6. The valve replacement system as described in claim 5, characterized in that, The outer perimeter of the disc section includes a superior arc segment, and the outer perimeter has a gap area compared to the complete circle in which the superior arc segment is located. The gap area constitutes a clearance portion.

7. The valve replacement system as described in claim 4, characterized in that, The disc section is provided with threading holes for the linear component to pass through; During deployment, one end of the linear component is fixedly connected to an anchoring component that is anchored into ventricular tissue, valve annulus tissue, or atrial tissue, and the other end extends outside the body and passes through the threading hole. The linear component guides the docking device to be delivered to the original atrioventricular valve.

8. The valve replacement system as described in claim 7, characterized in that, It also includes a cutting device for cutting off the portion of the linear member located near the locking member after the linear member is fixedly connected to the locking member.

9. The valve replacement system as described in claim 1, characterized in that, At least one of the anchoring elements is anchored into the interventricular septum tissue, at least another anchoring element is anchored into the valve annulus tissue corresponding to the original anterior leaflet or the atrial tissue adjacent to the original anterior leaflet, and at least a third anchoring element is anchored into the valve annulus tissue corresponding to the original posterior leaflet or the atrial tissue adjacent to the original posterior leaflet.

10. The valve replacement system as described in claim 4, characterized in that, The disc section is also equipped with location markers for pacing lead puncture.

11. The valve replacement system according to any one of claims 1-10, characterized in that, The anchoring element includes a nail seat and a spiral nail body connected to the nail seat, with the nail seat fixedly connected to one end of the linear element.

12. The valve replacement system according to any one of claims 1-10, characterized in that, The locking component includes a spindle, a first end cap fixedly disposed at the distal end of the spindle, a second end cap selectively movably disposed on the spindle and axially spaced from the first end cap, and a spring sleeved on the spindle between the first end cap and the second end cap. The linear component is disposed on each spring coil of the spring, and the second end cap can move toward the first end cap and be positioned at a predetermined position to compress the spring so that the linear component is clamped between adjacent spring coils.

13. The valve replacement system according to any one of claims 4-8, characterized in that, It also includes several auxiliary anchors, each of which passes directly through the disc segment and anchors into the valve annulus tissue and / or atrial tissue, so that the disc segment is attached to the valve annulus tissue and / or atrial tissue.

14. The valve replacement system as described in claim 2, characterized in that, The valve prosthesis includes a valve frame, a membrane covering the valve frame, and at least two artificial leaflets that can open and close relative to each other, the artificial leaflets being fixedly connected to the valve frame and / or the membrane.

15. The valve replacement system as described in claim 14, characterized in that, The valve frame includes a valve frame body, the valve frame body including a first section adjacent to a first end of the valve frame body, a second section adjacent to a second end of the valve frame body, and an intermediate section connecting the first section and the second section; the intermediate section is radially recessed inward relative to the first section and the second section; the intermediate section is interference-fitted into the receiving cavity of the docking device.

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