An internal locking mitral annuloplasty ring

Abstract

The present invention discloses a built-in locking mitral valve shaping ring, comprising: a contraction line, which has a shape memory function and is annular in a free state; a shaping ring body, which comprises a plurality of contraction sections which are sequentially sleeved on the outer periphery of the contraction line and are of a soft structure, and a contraction interval is provided between two adjacent contraction sections; the plurality of contraction sections comprise a head end contraction section, a plurality of middle section contraction sections and a tail end contraction section which are sequentially arranged; a clamping strip is provided on the head end contraction section, and a snake tube is provided in the accommodating cavity of the tail end contraction section. Under the action of the contraction line, the clamping strip of the shaping ring body can automatically extend into the snake tube and clamp with the snake tube so that the plurality of contraction sections are connected end to end to form an annular structure, and the snake tube can ensure its own compression and bending resistance in a certain direction, and can also ensure excellent bending performance in other directions. When used for connection, it can effectively ensure the stability of the contraction of the shaping ring body after the head and tail are connected and the smoothness when loaded into the conveying system.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a built-in locking mitral valvuloplasty ring. Background Art

[0002] Mitral valvuloplasty is used to treat mitral regurgitation heart valve disease by implanting a prosthetic mitral valvuloplasty ring. Prosthetic mitral valvuloplasty rings are used as part of a mitral valvuloplasty procedure to assist in the correction of heart valve defects such as mitral regurgitation. The mitral valve consists of the mitral valve annulus, valve leaflets, papillary muscles, and chordae tendineae. Mitral regurgitation is the reverse flow of blood from the left ventricle through the mitral valve to the left atrium when the left ventricle contracts. Dilation of the mitral valve annulus can impede the ability of the valve to open, resulting in a distortion of the normal shape of the valve orifice.

[0003] For the surgical treatment of mitral regurgitation, mitral valvuloplasty has obvious advantages over mitral valve replacement in terms of survival rate, valve complications and valve durability. There are two main types of mitral valvuloplasty rings currently used: rigid rings and flexible rings. The material of the rigid ring is relatively hard, not easy to bend, and cannot achieve coordinated movement with the cardiac cycle. The flexible ring is closer to the physiological activity of the normal mitral valve ring and has less effect on left ventricular function, but the support and shaping effect are poor, and mitral regurgitation is prone to recurrence after surgery, and the reoperation rate is relatively high.

[0004] Before performing mitral valvuloplasty, the shaping ring needs to be adjusted to a straight shape and loaded into the shaping ring loading cavity of the delivery system. The rigid ring is generally loaded into the shaping ring loading cavity in a foldable structure, but the delivery diameter of the rigid ring with a foldable structure is larger, and the size requirement of the shaping ring loading cavity is higher; although the flexible ring has a smaller delivery diameter, its support and shaping effects are poor, and mitral regurgitation is prone to recurrence after surgery.

[0005] Therefore, it is necessary to design a mitral valve shaping ring that can meet the support strength requirements and has a smaller delivery diameter. Summary of the invention

[0006] Therefore, the technical problem to be solved by the present invention is to overcome the defect of unstable contraction of the shaping ring after the end-to-end connection in the prior art, so as to provide an internal locking mitral valve shaping ring.

[0007] In order to solve the above technical problems, the technical solution of the present invention is as follows:

[0008] An internal locking mitral annuloplasty ring, comprising:

[0009] The contraction line has shape memory function and is ring-shaped in the free state;

[0010] The forming ring body comprises a plurality of contraction sections which are sequentially sleeved on the periphery of the contraction line and are of a soft structure, and a contraction interval is provided between two adjacent contraction sections; the plurality of contraction sections comprise a head contraction section, a plurality of middle contraction sections and a tail contraction section which are sequentially arranged;

[0011] A clamping strip is provided on the head end contraction joint, a snake tube is provided in the accommodation cavity of the tail end contraction joint, and the clamping strip extends into the snake tube and is clamped with the snake tube so that multiple contraction joints are connected end to end to form an annular structure.

[0012] Furthermore, a bar hook is provided on the outer surface of the clamping strip, and a snake positioning hole which is clamped with the bar hook is opened on the tube wall of the snake tube.

[0013] Furthermore, a plurality of the clamping bar barbs are arranged on the outer surface of the clamping bar, and a plurality of the snake bone positioning holes are arranged on the tube wall of the snake bone tube.

[0014] Furthermore, the clamping strip is a hollow tube, a plurality of through clamping holes are provided on the side wall of the clamping strip, and an inner folding arm clamped with the clamping holes is provided on the inner tube wall of the snake-bone tube.

[0015] Furthermore, the cross-sections of the clamping strip and the snake-bone tube are elliptical, concave clamping grooves are provided on opposite sides of the clamping strip, and an inner protrusion structure that is clamped with the concave clamping groove is provided on the inner tube wall of the snake-bone tube.

[0016] Furthermore, the clamping strip is in an arc shape or a straight line shape.

[0017] Furthermore, the annular structure formed by connecting the multiple contraction joints end to end is a discontinuous annular structure, and the surfaces of the two adjacent contraction joints at the contraction interval are cross-sections.

[0018] Furthermore, the annular structure formed by connecting the multiple contraction sections end to end is a complete annular structure, and two adjacent contraction sections are provided with a linking section at the contraction interval.

[0019] Furthermore, the shape of the annular structure formed by connecting the multiple contraction segments end to end matches the physiological structure of the human mitral valve.

[0020] Furthermore, the contraction joint is made of silicone material.

[0021] Furthermore, the shrink wire is made of memory alloy material.

[0022] Furthermore, the end surface of the head end contraction joint facing the tail end contraction joint is the wire outlet end, the end of the clamping strip located inside the wire outlet end is the clamping strip head end, and the other end of the clamping strip extending outside the wire outlet end is the clamping strip tail end; the clamping strip tail end extends into the snake bone tube.

[0023] Furthermore, one end of the contraction line is fixedly connected to the head end of the clamping strip, and the other end of the contraction line is fixedly connected to the tail end contraction section.

[0024] Furthermore, a traction hole is opened on the proximal side of the tail end contraction joint, a traction line is passed through the tail end of the clamping strip, and two ends of the traction line are connected to the conveying system after passing through the traction hole.

[0025] Furthermore, a guide groove is provided on each contraction section, and the contraction line includes a guide exposure section arranged corresponding to the opening of the guide groove, and a shaping guide line is wound around the guide exposure section, and two ends of the shaping guide line extend from the guide groove and are connected to the conveying system.

[0026] Further, the guide groove is arranged on a side of the contraction joint close to the center of the annular structure.

[0027] Furthermore, the surface of each contraction joint is coated with a coating substrate.

[0028] Furthermore, the coating substrate includes a nickel-titanium alloy mesh, and the nickel-titanium alloy mesh includes a coating segment coated on the surface of the contraction joint and an extension segment connected to the coating segment and extending outward in a direction away from the center of the annular structure.

[0029] Furthermore, the coating substrate also includes a ring-shaped PET mesh, which includes an upper PET mesh and a lower PET mesh, and the upper PET mesh and the lower PET mesh are coated on the outer surface of the extended section of the nickel-titanium alloy mesh.

[0030] Furthermore, the coating substrate also includes a ring-shaped PET mesh, and the PET mesh is coated on the outer surface of the multiple contraction joints and the multiple nickel-titanium alloy meshes.

[0031] Furthermore, the coating substrate also includes a plurality of fan-shaped sections of PET mesh cloth, and each section of the PET mesh cloth covers a corresponding section of the contraction joint and the outer surface of the nickel-titanium alloy mesh thereon.

[0032] Furthermore, the nickel-titanium alloy mesh is fan-shaped.

[0033] Furthermore, the shaping ring body is connected to the body's own valve leaflets via rivets passing through the covering substrate.

[0034] The technical solution of the present invention has the following advantages:

[0035] 1. The built-in locking mitral valve shaping ring provided by the present invention has a shaping ring body including a contraction line with a memory function and in a ring-shaped state in a free state and a plurality of contraction joints with a soft structure. When the shaping ring body passes through the atrial septum with the delivery system and arrives above the mitral valve, the delivery system is operated to release the shaping ring body. Under the action of the contraction line to restore the free form, the shaping ring body drives the plurality of contraction joints to be connected end to end to form a ring structure. Since the contraction joints are soft structures, they are closer to the physiological activities of the normal mitral valve ring and can achieve coordinated movement with the cardiac cycle. Since the contraction line is a rigid structure and has a memory function, the contraction line can provide a supporting force for the shaping ring body to maintain the ring state, so that the shaping ring body can meet the required supporting force requirements. Moreover, when the shaping ring body is loaded into the loading chamber of the delivery system, it can be in a straight line shape. Compared with the existing shaping ring body with a foldable structure, the delivery diameter is smaller, which is conducive to the smooth implantation of the mitral valve shaping ring. In addition, the front end contraction joint and the rear end contraction joint are connected through the snake tube and the clamping strip to form the forming ring body into an annular structure. When the forming ring body is released on the conveying system, the clamping strip and the snake tube can be automatically clamped under the action of the contraction line, reducing external force operation and facilitating the smooth progress of the operation. Moreover, as a commonly used medical material, the snake tube has the ability to ensure its own compression and bending resistance in a certain direction, and can also ensure excellent bending performance in other directions. When used for connection, it can effectively ensure the stability of the contraction of the forming ring body after the head and tail are connected and the smoothness when loaded into the conveying system.

[0036] 2. The built-in locking mitral valve forming ring provided by the present invention has a plurality of clamping barbs on the outer surface of the clamping bar, and a plurality of snake bone tube positioning holes on the tube wall of the snake bone tube. The connection of the plurality of clamping barbs and the plurality of snake bone tube positioning holes can enhance the connection reliability and reduce the risk of connection falling off.

[0037] 3. The built-in locking mitral valve forming ring provided by the present invention adopts a hollow tube as a clamping strip, and is provided with a plurality of through-holes on the side wall of the hollow tube, and an inner folding arm that is clamped with the clamping holes is provided on the inner tube wall of the snake tube; this method does not need to provide a clamping strip barb on the clamping strip, and only needs to punch holes on the clamping strip, thereby reducing the difficulty of processing and manufacturing.

[0038] 4. The built-in locking mitral valve shaping ring provided by the present invention has an elliptical cross-section of the clamping strip and the snake tube, and concave clamping grooves are provided on the opposite sides of the clamping strip. The inner tube wall of the snake tube is provided with an inner protrusion structure that is engaged with the concave clamping groove; the structure of the flat tube and the flat wire reduces the manufacturing and processing difficulty of the clamping strip and the snake tube, so that the shaping ring body can always be guaranteed not to be twisted through the elliptical cross-section during loading, releasing or contracting, thereby ensuring the stability of the shaping ring body when it is finally shaped.

[0039] 5. The built-in locking mitral valve shaping ring provided by the present invention has an arc-shaped clamping strip, which is adapted to the arc of the shaping ring body, and is conducive to the clamping strip being inserted into the inner part of the snake tube and automatically connected.

[0040] 6. The built-in locking mitral valve shaping ring provided by the present invention has a discontinuous annular structure formed by connecting multiple contraction segments end to end. When the conveying system is operated to release the shaping ring body, the contraction segments have a smaller obstructive force on the contraction line to restore the free form, which is conducive to the contraction segments being connected end to end to form an annular structure of the desired shape, so as to match the physiological structure of the human mitral valve.

[0041] 7. The built-in locking mitral annuloplasty ring provided by the present invention adopts a contraction joint made of silicone material, has good elasticity and biocompatibility, and can conform to the physiological activities of the human mitral valve ring.

[0042] 8. The built-in locking mitral valve shaping ring provided by the present invention has a guide groove on each contraction section, and the shaping guide wire is wound around the guide exposed section of the contraction wire corresponding to the guide groove, and the two ends of the shaping guide wire are connected to the conveying system after extending from the guide groove; by pulling the shaping guide wire through the conveying system, the shape of the shaping ring body after ring formation can be fine-tuned, so that the shaping ring body is shaped, which is conducive to forming a ring structure with a desired shape after the shaping ring body is released.

[0043] 9. The built-in locking mitral valve forming ring provided by the present invention has a traction hole on the proximal side of the tail end contraction segment, and a traction line is passed through the tail end of the clamping strip, and the two ends of the traction line are connected to the conveying system after passing through the traction hole; with such a configuration, the traction line can be operated by the conveying system to move, thereby driving the clamping strip to move into the tail end contraction segment, and the length of the clamping strip extending into the snake bone tube can be adjusted, thereby increasing the connection reliability between the snake bone tube and the clamping strip.

[0044] 10. The built-in locking mitral valve shaping ring provided by the present invention has a coating substrate coated on the surface of the contraction joint. The shaping ring body is connected to the body's own valve leaflet by rivets passing through the coating substrate, so there is no need to drill holes on the contraction joint. In addition, the coating substrate can be used as a base surface for rivet positioning, which is convenient for driving the rivet, avoiding the situation where the rivet positioning is inaccurate and repeated damage to the body's own biological tissue is caused when the rivet is pulled out.

[0045] 11. The internal locking mitral annuloplasty ring provided by the present invention encloses all locking elements in the contraction section, which can minimize the exposure of complex metal elements in the human blood flow, reduce contact with human physiological tissues, and reduce the incidence of thrombosis and abnormal tissue hyperplasia. After the contraction is completed, there is almost no exposure of the metal surface. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0047] Figure 1 A three-dimensional structural diagram of an internal locking mitral annuloplasty ring provided by an embodiment of the present invention;

[0048] Figure 2 A schematic diagram of the structure of an internal locking mitral annuloplasty ring provided by an embodiment of the present invention;

[0049] Figure 3 It is a schematic diagram of the wire outlet end and the wire collection end on the mitral annuloplasty ring in an embodiment of the present invention;

[0050] Figure 4 A front view of an internal locking mitral annuloplasty ring provided by an embodiment of the present invention;

[0051] Figure 5 for Figure 4 Cross-section of the middle AA surface;

[0052] Figure 6 FIG. 1 is a schematic diagram of a clamping strip and a snake tube on a mitral annuloplasty ring in an embodiment of the present invention;

[0053] Figure 7 This is a schematic diagram of the connection relationship between the coating substrate and the shrinkage joint in the first implementation mode of the embodiment of the present invention;

[0054] Figure 8 This is a schematic diagram of the connection relationship between the coated substrate and the shrinkage joint in the fourth implementation manner of the embodiment of the present invention;

[0055] Fig. 9 This is a schematic diagram of the connection relationship between the coated substrate and the shrinkage joint in the fifth implementation manner of the embodiment of the present invention;

[0056] Fig.10 This is a schematic diagram of the connection relationship between the coating substrate and the shrinkage joint in the sixth implementation manner of the embodiment of the present invention;

[0057] Fig.11 A diagram showing the positional relationship between the rivet and forming ring loading chambers on the conveying system provided in an embodiment of the present invention.

[0058] Fig.12 This is a schematic diagram of the connection relationship between the clamping strip and the snake tube in the first implementation mode of the embodiment of the present invention;

[0059] Fig.13This is a schematic diagram of the connection relationship between the clamping strip and the snake tube in the third implementation mode of the embodiment of the present invention;

[0060] Fig.14 FIG. 1 is a schematic diagram of the connection relationship between multiple snake tubes in an embodiment of the present invention;

[0061] Fig.15 FIG. 1 is a schematic diagram of the connection relationship between the contraction line, the clamping strip and the snake tube in an embodiment of the present invention;

[0062] Fig.16 This is a schematic diagram of the physiological anatomy of the human mitral valve;

[0063] Fig.17 This is a schematic diagram of a ring structure formed by connecting multiple contraction sections in a "D"-shaped shape end to end in a seventh implementation manner of an embodiment of the present invention;

[0064] Fig.18 This is a schematic diagram of a complete annular structure formed by connecting multiple contraction sections with linking sections end to end in an eighth implementation manner of an embodiment of the present invention.

[0065] Explanation of the reference numerals: 1. contraction section; 101. contraction interval; 102. guide groove; 110. head end contraction section; 111. outlet end; 120. middle section contraction section; 130. tail end contraction section; 131. wire collection end; 132. traction hole; 140. clamping strip; 141. clamping strip barb; 142. clamping strip head end; 143. clamping strip tail end; 144. clamping hole; 150. snake bone tube; 151. snake bone positioning hole; 160. connecting section; 2. contraction line; 201. guide exposure section; 3. shaping guide line; 4. traction line; 5. coating substrate; 501. nickel-titanium alloy mesh; 502. PET mesh cloth; 6. rivet; 7. forming ring loading cavity; 8. autologous leaflet. DETAILED DESCRIPTION

[0066] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0067] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0068] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0069] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0070] like Figure 1-4 The shown built-in locking mitral valve shaping ring includes a contraction wire 2 and a shaping ring body; wherein the contraction wire 2 has a shape memory function and is annular in a free state; the shaping ring body includes a plurality of contraction nodes 1 which are sequentially sleeved on the outer periphery of the contraction wire 2 and are of a soft structure, and a contraction interval 101 is provided between two adjacent contraction nodes 1.

[0071] For this built-in locking mitral valve shaping ring, when the shaping ring body passes through the atrial septum with the delivery system to reach the top of the mitral valve, the delivery system is operated to release the shaping ring body. Under the action of the contraction line 2 to restore the free form, the shaping ring body drives multiple contraction nodes 1 to be connected end to end to form a ring structure. Since the contraction node 1 is a soft structure, it is closer to the physiological activity of the normal mitral valve ring and can achieve coordinated movement with the cardiac cycle. Since the contraction line 2 is a rigid structure with a memory function, the contraction line 2 can provide the shaping ring body with a supporting force to maintain the ring state, so that the shaping ring body can meet the required supporting force requirements; moreover, when the shaping ring body is loaded into the loading chamber of the delivery system, it can be in a straight line shape. Compared with the existing foldable structure shaping ring body, the delivery diameter is smaller, which is conducive to the smooth implantation of the mitral valve shaping ring.

[0072] In a specific implementation of the present embodiment, the contraction joint 1 includes a head end contraction joint 110, four middle section contraction joints 120 and a tail end contraction joint 130, the head end contraction joint 110 is provided with a clamping strip 140, the accommodation cavity of the tail end contraction joint 130 is provided with a snake bone tube 150, the clamping strip 140 extends into the snake bone tube 150 and connects with the snake bone tube 150 so that the forming ring body is connected end to end to form a ring structure. In an alternative implementation, the number of the middle section contraction joints 120 can also be 2, 3, 5 or more. The head end contraction joint 110 and the tail end contraction joint 130 are connected through the snake bone tube 150 and the clamping strip 140 so that the forming ring body forms a ring structure. When the forming ring body is released on the conveying system, under the action of the contraction line 2, the clamping strip 140 and the snake bone tube 150 can automatically align the direction, so that the subsequent pulling of the traction line can realize the contraction of the forming ring, reduce external force operation, and facilitate the smooth progress of the operation. Moreover, as a commonly used medical material, the snake bone tube 150 has the ability to ensure its own compression and bending resistance in a certain direction, and also has excellent bending performance in other directions. When used for connection, it can effectively ensure the stability of the shrinkage of the forming ring body after the end-to-end connection and the smoothness when loaded into the conveying system. In an alternative embodiment, the positions of the snake bone tube 150 and the clamping strip 140 can be interchanged.

[0073] Specifically, the contraction joint 1 is made of silicone material, and the contraction wire 2 is made of nickel-titanium memory alloy material, and the contraction wire 2 is arranged between the multiple contraction joints 1. The contraction joint 1 made of silicone material has good biocompatibility and good elasticity, and can conform to the physiological activities of the mitral valve ring of the human body; and the silicone contraction joint 1 is a mass-produced material that can be produced by injection molding, and has the advantages of low production cost and high production efficiency. The nickel-titanium memory alloy has a strong function of restoring its own state, which is conducive to forming a forming ring body with an annular structure.

[0074] In a specific implementation of the present embodiment, the annular structure formed by connecting multiple contraction sections 1 end to end is an intermittent annular structure, and the surfaces of two adjacent contraction sections 1 at the contraction interval 101 are cross-sections; the annular structure formed by connecting multiple contraction sections 1 end to end has a "D" shape, which matches the physiological structure of the human mitral valve. For the shaping ring body of this structure, when the conveying system is operated to release the shaping ring body, the contraction section 1 has a smaller obstructive force on the contraction line 2 to restore the free form, which is conducive to the contraction section 1 being connected end to end to form an annular structure of the desired shape, so as to match the physiological structure of the human mitral valve. In an alternative implementation, the annular structure formed by connecting multiple contraction sections 1 end to end is a complete annular structure, and two adjacent contraction sections 1 are provided with a linking section 160 at the contraction interval 101.

[0075] In the first implementation of this embodiment, Figure 4-6As shown in 12, the outer surface of the clamping strip 140 is integrally formed with a plurality of clamping strip barbs 141 arranged along the length direction. The snake bone tube 150 is a tubular structure, and a plurality of snake bone positioning holes 151 are opened on the snake bone tube 150. By clamping the plurality of clamping strip barbs 141 and the plurality of snake bone positioning holes 151, the risk of slipping of the connection can be greatly reduced.

[0076] In the second implementation of the present embodiment, the difference from the first implementation is that the clamping strip 140 is a hollow tube, a plurality of through-holes 144 are provided on the side wall of the clamping strip 140, and an inner folding arm which is engaged with the clamping hole 144 is provided on the inner tube wall of the snake tube 150; this method does not need to set a clamping strip barb 141 on the clamping strip 140, and only needs to punch a hole on the clamping strip 140, thereby reducing the difficulty of processing and manufacturing.

[0077] In the third implementation of this embodiment, Fig.13 As shown, the difference from the second embodiment is that the snake tube 150 is a flat tube, the clamping strip 140 is a solid flat wire, the cross-sections of the clamping strip 140 and the snake tube 150 are both elliptical, the clamping strip 140 is provided with a plurality of concave clamping grooves on two opposite sides, and the inner tube wall of the snake tube 150 is provided with an inner protrusion structure that is clamped with the concave clamping grooves. The flat tube and flat wire structure is adopted, and the processing and manufacturing difficulty of the clamping strip 140 and the snake tube 150 is reduced, so that the forming ring body can always be guaranteed not to be twisted by the elliptical cross-section during loading, releasing or shrinking, thereby ensuring the stability of the forming ring body when it is finally formed.

[0078] In this embodiment, the end surface of the tail end contraction joint 130 facing the tail end contraction joint 130 is specifically the wire receiving end 131, and the end surface of the head end contraction joint 110 facing the tail end contraction joint 130 is specifically the wire outlet end 111. The snake tube 150 is connected to the wire receiving end 131; a part of the clamping strip 140 extends into the internal cavity of the wire outlet end 111, and another part extends outward from the wire outlet end 111.

[0079] In a specific implementation of this embodiment, the clamping strip 140 is arc-shaped and can adapt to the curvature of the forming ring body, which is conducive to the clamping strip 140 being inserted into the interior of the snake bone tube 150 and automatically clamping. The end of the clamping strip 140 located inside the outlet end 111 is the clamping strip head end 142, and the other end of the clamping strip 140 extending outside the outlet end 111 is the clamping strip tail end 143. One end of the contraction line 2 is fixedly connected to the clamping strip head end 142, and the other end of the contraction line 2 passes through the head end contraction section 110, passes through the middle section contraction section 120 and the tail end contraction section 130 in sequence, and is fixedly connected to the snake bone tube 150. In an alternative implementation, the clamping strip 140 can also be linear, and the other end of the contraction line 2 can also be fixedly connected to the tail end contraction section 130.

[0080] In this embodiment, if Figure 1 As shown, a guide groove 102 is provided on one side of each contraction section 1 close to the center of the annular structure, and the portion of the contraction line 2 corresponding to the opening of the guide groove 102 is a guide exposed section 201, and a shaping guide line 3 is wound around the guide exposed section 201, and the two ends of the shaping guide line 3 extend from the guide groove 102 and are connected to the conveying system. By pulling the shaping guide line 3 through the conveying system, the shape of the forming ring body after the ring is formed can be fine-tuned, so that the forming ring body is shaped, which is conducive to forming a ring structure of the desired shape after the forming ring body is released, and the forming ring is stably connected to the conveying system.

[0081] In this embodiment, if Figure 2 As shown, a traction hole 132 is provided on the proximal side of the tail end contraction joint 130, and a traction line 4 is passed through the tail end 143 of the clamping strip, and the two ends of the traction line 4 are connected to the conveying system after passing through the tail end 143 of the clamping strip and the traction hole 132 in turn. Among them, the proximal end and the distal end refer to the end close to the operator and the end far away from the operator, respectively. In this arrangement, the traction line 4 can be operated by the conveying system to move, thereby driving the clamping strip 140 to move into the tail end contraction joint 130, and the length of the clamping strip 140 extending into the snake bone tube 150 can be adjusted, thereby increasing the connection reliability between the snake bone tube 150 and the clamping strip 140, and realizing the formed contraction.

[0082] In this embodiment, if Figure 1-3 As shown in 7-10, the surface of each contraction segment 1 is coated with a coating substrate 5 that matches it. The shaping ring body is connected to the body's own valve leaflet through the rivet 6 that passes through the coating substrate 5; this method does not require drilling holes on the contraction segment 1, and the coating substrate 5 can be used as a base surface for positioning the rivet 6, which is convenient for driving the rivet 6, avoiding the problem of inaccurate positioning of the rivet 6 and easy falling off.

[0083] In the first implementation of this embodiment, Figure 7 As shown, the coating substrate 5 includes a nickel-titanium alloy mesh 501, which is fan-shaped. The nickel-titanium alloy mesh 501 includes a coating section that is coated on the surface of the contraction joint 1 and an extension section that is connected to the coating section and extends outward in a direction away from the center of the annular structure. Under the action of the nickel-titanium alloy mesh 501, the nickel-titanium alloy mesh 501 can maintain a fan-shaped surface to fit the upper surface of the body's own valve leaflet, and the extension section of the nickel-titanium alloy mesh 501 can facilitate the rivet 6 to be accurately driven into the human biological tissue.

[0084] In the fourth implementation of this embodiment, Figure 8As shown, the difference from the first embodiment is that the coating substrate 5 also includes a ring-shaped PET mesh 502, and the PET mesh 502 includes an upper PET mesh 502 and a lower PET mesh 502, and the upper PET mesh 502 and the lower PET mesh 502 are sewed and coated on the outer surface of the extended section of the nickel-titanium alloy mesh 501.

[0085] In the fifth implementation of this embodiment, Fig. 9 As shown, the difference from the fourth embodiment is that the PET mesh cloth 502 is coated on the outer surface of the multi-section contraction joint 1 and the plurality of nickel-titanium alloy meshes 501 .

[0086] In the sixth implementation of this embodiment, Fig.10 As shown, the difference from the fifth embodiment is that the coated substrate 5 has multiple sections, each section of the coated substrate 5 is fan-shaped, there is a gap between two adjacent sections of the coated substrate 5, and the length of the part of each section of the coated substrate 5 covering the corresponding contraction joint 1 is the same as the length of the contraction joint 1.

[0087] In this embodiment, the structure of the conveying system is as follows: Fig.11 As shown, a shaping ring loading chamber 7 is provided in the middle of the conveying system. Before the operation is performed, the shaping ring body is loaded into the shaping ring loading chamber 7 of the conveying system in a straight line. The conveying system is also connected to a plurality of rivets 6 located on the outer periphery of the shaping ring loading chamber 7 on the end face of the outlet of the shaping ring loading chamber 7. The rivets 6 are used to fix the shaping ring body on the outer circumferential part of the autologous valve leaflet. Specifically, the rivets 6 pass through the upper PET mesh 502, the nickel-titanium alloy mesh 501, the lower PET mesh 502 and the autologous valve leaflet from top to bottom in sequence and then pass out. The upper end of the rivet 6 is mounted on the PET mesh 502 and the nickel-titanium alloy mesh 501 through a barb-shaped structure or other structures, and the lower end of the rivet 6 is abutted against the lower surface of the autologous valve leaflet through a barb-shaped structure. After the shaping ring body is initially formed by the contraction line 2, the corresponding rivet 6 is driven in to form a ring structure of the desired shape.

[0088] In this embodiment, if Figure 1-10 As shown in the figure, the annular structure formed by connecting the multiple contraction segments 1 of the built-in locking mitral annuloplasty ring end to end is in the shape of a circular ring that matches the physiological structure of the human mitral valve;

[0089] In this embodiment, if Fig.16 The physiological anatomy diagram of the human mitral valve is shown as follows: the physiological structure of the human mitral valve is close to a "D" shape, wherein the edge of the A area (including A1, A2, A3) is a straight edge close to the "D" shape, and the edge of the P area (including P1, P2, P3) is an arc edge close to the "D" shape;

[0090] In the seventh implementation of this embodiment, Fig.17As shown, in order to be closer to the physiological structure of the human mitral valve, in a preferred embodiment, the annular structure formed by connecting the multiple contraction segments 1 end to end is in a "D" shape that matches the physiological structure of the human mitral valve. Specifically, at least one of the multiple contraction segments 1 is a straight contraction segment; the straight contraction segment corresponds to the edge of the A zone of the physiological structure of the human mitral valve, and the other contraction segments 1 are attached to the edge of the P zone of the physiological structure of the human mitral valve; further, both ends of the straight contraction segment are provided with bending heads, and the bending heads are bent toward the adjacent contraction segments 1;

[0091] In the eighth implementation of this embodiment, if Fig.18 As shown, in another feasible embodiment, the annular structure formed by connecting the multiple contraction nodes 1 end to end is a complete annular structure, and the two adjacent contraction nodes 1 are provided with a linking segment 160 at the contraction interval. Specifically, the linking segment 160 makes the adjacent contraction nodes 1 always separated by a certain distance; during the operation, after the shaping ring body is fixed to the autologous valve leaflet 8, the linking segment 160 will be compressed when the traction line is pulled. During the compression process, the linking segment 160 bends outward in an "Ω" shape, and the shaping ring body forms an annular structure similar to the above-mentioned embodiment.

[0092] The working principle of this built-in locking mitral annuloplasty ring is as follows: before the operation, the annuloplasty ring body is adjusted to a straight line and loaded into the annuloplasty ring loading chamber 7 of the delivery system. At this time, the annuloplasty ring is composed of a snake tube 150, a tail end contraction section 130, a four-section middle section contraction section 120, and a head end contraction section 110 in the direction from the proximal end to the distal end. When the delivery system reaches the top of the mitral valve through the atrial septum, the delivery system is operated to release the annuloplasty ring body, and the annuloplasty ring body is initially formed into a ring shape under the action of the contraction wire 2 made of nickel-titanium alloy. The surface of the contraction joint 1 is coated with a nickel-titanium alloy mesh 501 and a PET mesh 502. Under the fine-tuning operation of the nickel-titanium alloy mesh 501 and the shaping guide wire 3, the shaping ring body is shaped and the fan-shaped surface is maintained to fit the upper surface of the body's autologous valve leaflets. By operating the conveying system, a number of rivets 6 are pierced, passing through the body's autologous valve leaflets, the lower PET mesh, the nickel-titanium alloy mesh, and the upper PET mesh in turn, and finally the shaping ring is fixed to the autologous valve leaflets through the barbs or thorns on the rivets 6.

[0093] After the shaping ring body is fixed to the autologous valve leaflet, the clamping strip 140 is inserted toward the snake tube 150 by pulling the traction line 4 until the shaping ring is shrunk to the required size, and the snake positioning hole 151 of the snake tube 150 and the clamping strip barb 141 are locked with each other to complete the contraction. When disconnecting the delivery system, one end of each traction line 4 is cut off and the other end is pulled to retract.

[0094] In summary, the built-in locking mitral annuloplasty ring provided by the embodiment of the present invention, when the annuloplasty ring body passes through the atrial septum with the delivery system to reach above the mitral valve, the delivery system is operated to release the annuloplasty ring body, and the annuloplasty ring body drives multiple contraction nodes 1 to be connected end to end to form an annular structure under the action of the contraction line 2 to restore the free form. Since the contraction node 1 is a soft structure, it is closer to the physiological activity of the normal mitral valve ring and can achieve coordinated movement with the cardiac cycle. Since the contraction line 2 is a rigid structure and has a memory function, the contraction line 2 can provide the annular state with a supporting force for the annular state of the annular ring body, so that the annular ring body can meet the required supporting force requirements; moreover, when the annular ring body is loaded into the loading chamber of the delivery system, it can be in a straight line shape. Compared with the existing foldable annuloplasty ring body, the delivery diameter is smaller, which is conducive to the smooth implantation of the mitral annuloplasty ring. In addition, the front end contraction joint 110 and the rear end contraction joint 130 are connected through the snake tube 150 and the clamping strip 140 to form a ring structure of the shaping ring body. When the shaping ring body is released on the conveying system, under the action of the contraction line 2, the clamping strip 140 and the snake tube 150 can be automatically clamped, reducing external force operation, which is conducive to the smooth progress of the operation. Moreover, as a commonly used medical material, the snake tube 150 has the ability to ensure its own compression and bending resistance in a certain direction, and can also ensure excellent bending performance in other directions. When used for connection, it can effectively ensure the stability of the shaping ring body after the head and tail are connected and the smoothness when loaded into the conveying system.

[0095] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. An internal locking mitral annuloplasty ring, characterized in that: include: The contraction line (2) has a shape memory function and is in a ring shape in a free state; The forming ring body comprises a plurality of contraction joints (1) which are sequentially sleeved on the outer periphery of the contraction line (2) and are of a soft structure, and a contraction interval (101) is provided between two adjacent contraction joints (1); the plurality of contraction joints (1) comprise a head end contraction joint (110), a plurality of middle section contraction joints (120) and a tail end contraction joint (130) which are sequentially arranged; The head end contraction joint (110) is provided with a clamping strip (140), the accommodation cavity of the tail end contraction joint (130) is provided with a snake bone tube (150), the clamping strip (140) extends into the snake bone tube (150) and is clamped with the snake bone tube (150) so that the multiple contraction joints (1) are connected end to end to form an annular structure; A guide groove (102) is provided on each of the contraction sections (1); the contraction line (2) comprises a guide exposed section (201) arranged corresponding to the opening of the guide groove (102); a shaping guide line (3) is wound around the guide exposed section (201); two ends of the shaping guide line (3) extend from the guide groove (102) and are connected to a conveying system.

2. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The outer surface of the clamping strip (140) is provided with a clamping strip barb (141), and the tube wall of the snake bone tube (150) is provided with a snake bone positioning hole (151) clamped with the clamping strip barb (141).

3. The internal locking mitral annuloplasty ring according to claim 2, characterized in that: A plurality of the clamping bar hooks (141) are arranged on the outer surface of the clamping bar (140), and a plurality of the snake bone positioning holes (151) are arranged on the tube wall of the snake bone tube (150).

4. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The clamping strip (140) is a hollow tube, a plurality of through-holes (144) are provided on the side wall of the clamping strip (140), and an inner folding arm clamped with the clamping holes (144) is provided on the inner tube wall of the snake bone tube (150).

5. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The cross-sections of the clamping strip (140) and the snake-bone tube (150) are elliptical, and concave clamping grooves are provided on opposite sides of the clamping strip (140). An inner protrusion structure that is clamped with the concave clamping groove is provided on the inner tube wall of the snake-bone tube (150).

6. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The clamping strip (140) is in an arc shape or a straight line shape.

7. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The annular structure formed by connecting the multiple contraction joints (1) end to end is a discontinuous annular structure, and the surfaces of the two adjacent contraction joints (1) at the contraction interval (101) are cross-sections.

8. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The annular structure formed by connecting the multiple contraction sections (1) end to end is a complete annular structure, and two adjacent contraction sections (1) are provided with a linking section (160) at the contraction interval (101).

9. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The appearance of the annular structure formed by connecting the multiple contraction segments (1) end to end matches the physiological structure of the human mitral valve.

10. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The contraction joint (1) is made of silicone material.

11. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The shrink wire (2) is made of memory alloy material.

12. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The end surface of the head end contraction joint (110) facing the tail end contraction joint (130) is the wire outlet end (111); the end of the clamping strip (140) located inside the wire outlet end (111) is the clamping strip head end (142); the other end of the clamping strip (140) extending outside the wire outlet end (111) is the clamping strip tail end (143); the clamping strip tail end (143) extends into the snake bone tube (150).

13. The internal locking mitral annuloplasty ring according to claim 12, characterized in that: One end of the contraction line (2) is fixedly connected to the head end (142) of the clamping strip, and the other end of the contraction line (2) is fixedly connected to the tail end contraction section (130).

14. The internal locking mitral annuloplasty ring according to claim 12, characterized in that: A traction hole (132) is provided on the proximal side of the tail end contraction joint (130), a traction line (4) is passed through the tail end (143) of the clamping strip, and the two ends of the traction line (4) pass through the traction hole (132) and are connected to the conveying system.

15. The internal locking mitral annuloplasty ring according to claim 1, characterized in that: The guide groove (102) is arranged on a side of the contraction joint (1) close to the center of the annular structure.

16. The internal locking mitral annuloplasty ring according to any one of claims 1 to 14, characterized in that: The surface of each contraction joint is coated with a coating substrate (5).

17. The internal locking mitral annuloplasty ring according to claim 16, characterized in that: The coated substrate (5) comprises a nickel-titanium alloy mesh (501), and the nickel-titanium alloy mesh (501) comprises a coating section coated on the surface of the contraction joint and an extension section connected to the coating section and extending outward in a direction away from the center of the annular structure.

18. The internal locking mitral annuloplasty ring according to claim 17, characterized in that: The coating substrate (5) further comprises a ring-shaped PET mesh (502), wherein the PET mesh (502) comprises an upper layer of PET mesh (502) and a lower layer of PET mesh (502), wherein the upper layer of PET mesh (502) and the lower layer of PET mesh (502) are coated on the outer surface of the extension section of the nickel-titanium alloy mesh (501).

19. The internal locking mitral annuloplasty ring according to claim 17, characterized in that: The coating substrate (5) further comprises a ring-shaped PET mesh cloth (502), wherein the PET mesh cloth (502) is coated on the outer surfaces of the plurality of contraction joints and the plurality of nickel-titanium alloy meshes (501).

20. The internal locking mitral annuloplasty ring according to claim 17, characterized in that: The coating substrate (5) further comprises a plurality of fan-shaped sections of PET mesh cloth (502), each section of the PET mesh cloth (502) coating a corresponding section of the contraction joint and the outer surface of the nickel-titanium alloy mesh (501) thereon.

21. The internal locking mitral annuloplasty ring according to claim 17, characterized in that: The nickel-titanium alloy mesh (501) is fan-shaped.

22. The internal locking mitral annuloplasty ring according to claim 21, characterized in that: The shaping ring body is connected to the body's own valve leaflets via rivets (6) passing through the covering substrate (5).

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