A mitral annuloplasty device

Abstract

The present invention discloses a mitral valve annulus contraction device, comprising a shaping ring body, a metal tube having a shape memory function, an automatic contraction section on the metal tube, the automatic contraction section comprising an inner connecting strip and an outer connecting strip located on the inner and outer sides of the shaping ring body; a fixing pin is connected between the inner connecting strip and the outer connecting strip, a stop pin is passed through the fixing pin, and a stop pin pull wire is passed through the stop pin. By providing a metal tube having a shape memory function, the mitral valve annulus contraction device is an annular structure similar to a heart valve before use, and the inner connecting strip and the outer connecting strip are fixed by the fixing pin to form a shape convenient for implantation. When the mitral valve annulus contraction device reaches the implantation position, the stop pin and the fixing pin are pulled out, so that the automatic contraction section on the metal tube automatically returns to an annular structure similar to a heart valve in its initial state under the shape memory function of the metal tube. The structure is simpler, the production cost is low, and the operation process is convenient.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a mitral valve annulus contraction device. Background Art

[0002] Mitral valvuloplasty is a procedure used to treat mitral regurgitation heart valve disease by implanting a prosthetic mitral annuloplasty ring. A prosthetic mitral annuloplasty ring is 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 annulus, 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 annulus impedes 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 significant advantages over mitral valve replacement in terms of survival rate, valve complications, and valve durability. Currently, there are two main types of mitral valvuloplasty rings in common use: rigid rings and flexible rings. Rigid rings are made of a harder material, are difficult to bend, and cannot achieve coordinated movement with the cardiac cycle. Flexible rings are closer to the physiological activity of the normal mitral valve annulus and have less impact on left ventricular function, but their support and shaping effects are poor. Mitral regurgitation is more likely to recur after surgery, and the reoperation rate is relatively high.

[0004] Before performing a mitral valvuloplasty, the annuloplasty ring must be adjusted to a straight shape and loaded into the annuloplasty ring loading chamber of the delivery system. Rigid annuloplasty rings are typically loaded into the annuloplasty ring loading chamber using a foldable structure. However, these foldable rigid annuloplasty rings have a larger delivery diameter, requiring a larger annuloplasty chamber. Flexible annuloplasty rings, while smaller in delivery diameter, provide less support and shaping, making postoperative mitral regurgitation more likely to recur. Existing, automatically retractable annuloplasty rings typically use a snake-like structure, but these are complex, difficult to manufacture, and expensive to produce. Summary of the Invention

[0005] Therefore, the technical problem to be solved by the present invention is to overcome the defects of the prior art mitral annuloplasty ring made of a snake tube, such as the complex structure and high production cost, thereby providing a mitral annuloplasty device.

[0006] In order to solve the above technical problems, the technical solutions of the present invention are as follows:

[0007] A mitral valve annuloplasty device, comprising:

[0008] The shaping ring body comprises a metal tube with shape memory function, wherein the two ends of the metal tube are connected by a snap assembly so that the shaping ring body is connected end to end to form an annular structure;

[0009] The metal tube is provided with an automatic shrinking section, which includes an inner connecting strip and an outer connecting strip located on the inner and outer sides of the forming ring body and are not directly connected; a fixing nail is connected between the inner connecting strip and the outer connecting strip, and one end of the fixing nail passing through the inner connecting strip is provided with a stop pin blocking one side of the inner connecting strip, and a stop pin pull wire is provided on the stop pin.

[0010] Furthermore, a recovery line hole is opened on a side of the fixing nail away from the stop pin, and a fixing nail recovery line is passed through the recovery line hole.

[0011] Furthermore, the outer connecting bar is provided with an avoidance groove; when the inner connecting bar and the outer connecting bar are fixed by the fixing nail, the portion of the inner connecting bar connected to the fixing nail is embedded in the avoidance groove.

[0012] Furthermore, in the axial direction of the annular structure formed by the forming ring body, the width of the outer connecting strip is greater than the width of the inner connecting strip.

[0013] Furthermore, after the fixing nail on the automatic contraction section is pulled out, the inner connecting strip and the outer connecting strip are in a single peak shape or a single Ω shape in a natural state, and the convex parts of the inner connecting strip and the outer connecting strip are in the same position and in opposite convex directions.

[0014] Furthermore, after the fixing nail on the automatic contraction section is pulled out, the inner connecting strip and the outer connecting strip are in a double wave peak shape or a double Ω shape in a natural state, and the two convex parts on the inner connecting strip and the outer connecting strip are in the same position and in opposite convex directions.

[0015] Furthermore, the metal tube further comprises a metal tube segment with a rectangular cross section and enclosed on four sides, and the automatic shrinking segment is connected between two of the metal tube segments.

[0016] Furthermore, the metal tube is made of memory alloy, and the metal tube section and the automatic shrinkage section are an integrally formed structure.

[0017] Furthermore, a plurality of avoidance gaps are provided on the inner side of the metal pipe section; the avoidance gaps are U-shaped or V-shaped.

[0018] Furthermore, the outer periphery of the metal pipe segment is coated with a coating base material.

[0019] Furthermore, a plurality of shaping guide wires are wound around the metal tube.

[0020] Furthermore, the snap assembly includes a snap head end connected to one end of the metal tube, and a snap fixing end connected to the other end of the metal tube; the snap head end is provided with a head end guide head, and the interior of the snap fixing end is provided with an accommodating cavity that can accommodate the head end guide head.

[0021] The technical solution of the present invention has the following advantages:

[0022] 1. The mitral valve annulus contraction device provided by the present invention is provided with a metal tube with a shape memory function, the metal tube includes an automatic contraction section, the automatic contraction section includes an inner connecting strip and an outer connecting strip, a fixing nail is connected between the inner connecting strip and the outer connecting strip, a stop pin is passed through the fixing nail, and a stop pin pull wire is passed through the stop pin; the mitral valve annulus contraction device is in a straight line before surgical implantation, and the mitral valve annulus contraction device is released after reaching the implantation position with the input system, and the metal tube automatically restores the annular structure similar to the heart valve under the shape memory function, and then the two ends of the metal tube are automatically locked by the buckle assembly to form a complete annular shape; because the automatic contraction section is in its own shape The memory function has an automatic contraction function, but due to the presence of the fixing pin and the stop pin, the inner connecting strip and the outer connecting strip are locked by the fixing pin and temporarily do not contract; when adjusting the annular shape of the mitral valve annulus contraction device, the stop pin pull wire is pulled, the stop pin is pulled out, and the locking of the inner connecting strip and the outer connecting strip by the fixing pin is released. The inner connecting strip and the outer connecting strip contract under the function of their own shape memory to restore their original shape. During the contraction process, the ring-shaped metal tube will be driven to shrink and become smaller, thereby realizing the adjustment of the annular shape of the metal tube. Compared with the method of adjusting the shape of the forming ring by using a contraction traction line in the prior art, the structure is simpler, the production cost is low, and the operation process is convenient.

[0023] 2. The mitral valve annulus contraction device provided by the present invention has an avoidance groove provided on the outer connecting strip, and the structural design in which the portion of the inner connecting strip connected to the fixing pin is embedded in the avoidance groove can make the deformable space of the inner connecting strip larger, the elastic change amount larger, the contraction change amount of the inner connecting strip under its own shape memory function is also larger, and the corresponding outer shape contraction adjustment amount of the forming ring body is also larger.

[0024] 3. In the mitral valve annulus contraction device provided by the present invention, the inner connecting strip and the outer connecting strip are in a single wave peak shape or a single Ω shape in a natural state, and the positions of the convex parts of the inner connecting strip and the outer connecting strip are the same and the convex directions are opposite; the elastic variation of the inner connecting strip and the outer connecting strip of this shape is large, which can make the contraction of the forming ring body greater.

[0025] 4. The mitral valve annulation device provided by the present invention comprises a metal tube further comprising a metal tube end with a rectangular cross-section and enclosed on four sides. This design can avoid twisting during implantation and reduce the projected area of the shaping ring body, thereby optimizing the effect on hemodynamics and improving the effect of heart valve repair. At the same time, due to the presence of long sides in the rectangular cross-section, it is more suitable for the valve-in-ring than in the circular cross-section, and can provide the valve-in-ring of the mitral valve replacement with a larger contact area.

[0026] 5. The mitral valve annulus contraction device provided by the present invention has an integrated metal tube section and an automatic contraction section. Such a design allows for laser cutting, making production and processing easier and reducing production costs.

[0027] 6. The mitral valve annulation device provided by the present invention has a plurality of shaping guide wires wound around the metal tube. With such a design, when operating the delivery system, the shaping guide wires can be tightened to enable the shaping ring body to be assisted in shaping and fit the surface of the body's own valve leaflet, so as to facilitate the operation of the delivery system to implant the rivets. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0029] Figure 1 A three-dimensional structural diagram of the mitral valve annulation device provided by the present invention;

[0030] Figure 2 The mitral valve annuloplasty device provided by the present invention;

[0031] Figure 3 A cross-sectional view of the forming ring body provided by the present invention;

[0032] Figure 4 This is a diagram showing the connection between the forming ring body and the coating substrate in this embodiment;

[0033] Figure 5 This is a schematic structural diagram of a single-peak wave-shaped automatic contraction section in this embodiment;

[0034] Figure 6 This is a schematic structural diagram of the double-peak wave-shaped automatic contraction section in this embodiment;

[0035] Figure 7 This is a schematic structural diagram of a single Ω-shaped automatic contraction section in this embodiment;

[0036] Figure 8Schematic diagram of the structure of the double Ω-shaped automatic contraction section in this embodiment.

[0037] Explanation of the accompanying drawings: 01, forming ring body; 02, coating substrate; 03, shaping guide line; 10, metal tube; 11, automatic shrinkage section; 111, inner connecting strip; 112, outer connecting strip; 1121, avoidance groove; 12, metal tube section; 121, avoidance gap; 20, fixing nail; 21, recovery line hole; 22, fixing nail recovery line; 30, stop pin; 31, stop pin pull line; 40, buckle assembly; 41, buckle head end; 411, head end guide head; 42, buckle fixed end; 43, buckle traction line; 51, soft coating substrate; 52, mesh substrate; 53, coating film. DETAILED DESCRIPTION

[0038] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0039] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0040] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0041] 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.

[0042] like Figure 1-8A mitral valve annulation device is shown, comprising a ring body 01, wherein the ring body 01 comprises a metal tube 10 with shape memory function. The two ends of the metal tube 10 are connected by a snap assembly 40, so that the ring body 01 is connected end to end to form an annular structure. The metal tube 10 has an automatic contraction section 11, which includes an inner connecting strip 111 and an outer connecting strip 112 located on the inner and outer sides of the ring body 01 and not directly connected. A fixing pin 20 is connected between the inner and outer connecting strips 111 and 112. The end of the fixing pin 20 that passes through the inner connecting strip 111 is penetrated by a stop pin 30 that blocks the side of the inner connecting strip 111. The stop pin 30 is penetrated by a stop pin pull wire 31.

[0043] This mitral valve annulus contraction device is provided with a metal tube 10 with a shape memory function. The metal tube 10 includes an automatic contraction section 11. The automatic contraction section 11 includes an inner connecting strip 111 and an outer connecting strip 112. A fixing nail 20 is connected between the inner connecting strip 111 and the outer connecting strip 112. A stop pin 30 is passed through the fixing nail 20. A stop pin pull wire 31 is passed through the stop pin 30. The mitral valve annulus contraction device is in a straight line before surgical implantation. The mitral valve annulus contraction device is released after the input system reaches the implantation position. The metal tube automatically restores the annular structure similar to the heart valve under the shape memory function, and then the two ends of the metal tube are automatically locked by the snap assembly 10 to form a complete ring. Since the automatic contraction section 11 has its own shape memory function, The shape memory function has an automatic contraction function, but due to the presence of the fixing pin 20 and the stop pin 30, the inner connecting strip 111 and the outer connecting strip 112 are locked by the fixing pin 20 and temporarily do not contract; when adjusting the annular shape of the mitral valve annulus contraction device, the stop pin pull line 31 is pulled, the stop pin 30 is pulled out, and the locking of the inner connecting strip 111 and the outer connecting strip 112 by the fixing pin 20 is released, and the inner connecting strip 111 and the outer connecting strip 112 contract under the function of their own shape memory to restore their original shape. During the contraction process, the ring-shaped metal tube will be driven to shrink and become smaller, thereby realizing the adjustment of the annular shape of the metal tube. Compared with the method of using a contraction traction line to adjust the shape of the forming ring in the prior art, the structure is simpler, the production cost is low, and the operation process is convenient.

[0044] In this embodiment, the metal tube 10 also includes a metal tube segment 12 with a rectangular cross-section and surrounded on all four sides, and the automatic contraction segment 11 is located between the two metal tube segments 12. This design can not only avoid twisting during implantation, but also reduce the projected area of the shaping ring body 01, optimize the impact on blood dynamics, and improve the effect of heart valve repair; at the same time, due to the presence of long sides in the rectangular cross-section, it is more suitable for the annular valve than the circular cross-section, and can provide a larger contact area for the annular valve of mitral valve replacement. Specifically, the metal tube 10 is made of a memory alloy material, and the metal tube segment 12 and the automatic contraction segment 11 are an integrally formed structure. This design can be cut and processed by laser, making production and processing easier and reducing production costs.

[0045] In this embodiment, in the circumferential direction of the annular structure enclosed by the forming ring body 01, the width of the outer connecting bar 112 is greater than the width of the inner connecting bar 111. The outer connecting bar 112 is provided with a relief groove 1121. When the inner and outer connecting bars 111 and 112 are fixedly connected by the fixing pin 20, the portion of the inner connecting bar 111 connected to the fixing pin 20 is embedded in the relief groove 1121 of the outer connecting bar 112.

[0046] In this embodiment, the fixing pin 20 is inserted through the outer connecting strip 112 and the middle portion of the outer connecting strip 112. A retrieval line hole 21 is formed on the side of the fixing pin 20 away from the stop pin 30. A fixing pin retrieval line 22 is inserted through the retrieval line hole 21. The fixing pin retrieval line 22 is pulled to retract the fixing pin 20, completing the repair and shaping of the autologous valve leaflet.

[0047] In this embodiment, after the fixing pins 20 on the automatically retracting section 11 are removed, the inner and outer connecting strips 111, 112 naturally assume a single wave or single Ω shape, with the convex portions of the inner and outer connecting strips 111, 112 positioned in the same direction but convex in opposite directions. This shape of the inner and outer connecting strips 111, 112 allows for a greater degree of elastic variation, allowing the forming ring body 01 to contract more significantly.

[0048] In an alternative embodiment, after the fixing nail 20 on the automatic shrinking section 11 is pulled out, the inner connecting strip 111 and the outer connecting strip 112 are in a double wave-peak shape or a double Ω shape in a natural state, and the two convex parts on the inner connecting strip 111 and the outer connecting strip 112 are in the same position and in opposite convex directions.

[0049] In this embodiment, a number of shaping guide wires 03 are wound around the metal tube 10, and a number of avoidance notches 121 are provided on the inner side of the metal tube segment 12, and the avoidance notches 121 are U-shaped or V-shaped. The provision of the avoidance notches 121 can avoid mutual interference in the morphological changes of each section of the metal tube segment 12, making it easier for the metal tube 10 to deform under its own morphological memory function. Specifically, two shaping guide wires 03 are provided on each automatic contraction segment 11, and two shaping guide wires 03 are provided on the metal tube 10 away from the buckle assembly 40 and provided with the avoidance notches 121. The design of the shaping guide wires 03 can, when operating the delivery system, by tightening the shaping guide wires 03, enable the shaping ring body 01 to obtain auxiliary shaping and fit the surface of the body's own leaflet, so as to facilitate the operation of the delivery system to implant rivets.

[0050] In this embodiment, the buckle assembly 40 includes a buckle head end 41 connected to one end of the metal tube 10, and a buckle fixed end 42 connected to the other end of the metal tube 10. Specifically, a head end guide 411 is integrally formed on the buckle head end 41, and a receiving cavity for accommodating the head end guide 411 is defined within the buckle fixed end 42.

[0051] Specifically, the head end guide head 411 is provided with a head end traction hole; the clip fixed end 42 is provided with a fixed end traction hole corresponding to the position of the head end guide head 411; the fixed end traction hole communicates with the accommodating cavity. A clip traction line 43 is passed between the head end traction hole and the fixed end traction hole. The two ends of the clip traction line 43 extend outward from the avoidance gap 121 near the head end guide head.

[0052] In this embodiment, the outer periphery of the metal tube segment 12 is coated with a coating substrate 02. The coating substrate 02 comprises a coating segment that coats the surface of the forming ring body 01 and an extension segment that connects to the forming ring body 01 and extends outwardly away from the center of the annular structure formed by the forming ring body 01. Specifically, the coating substrate 02 comprises a soft coating substrate 51, a mesh substrate 52 that coats the soft coating substrate 51, and a coating film 53 that coats the mesh substrate 52. The coating film 53 comprises an upper coating film and a lower coating film.

[0053] Working Principle: Before surgery, the mitral valve annulus device is loaded into the delivery system before implantation. It assumes a straight shape, with the buckle tip 41 of the ring body 01 facing the surgeon, and the buckle fixing end 42 of the ring body 01 facing the surgeon. Upon reaching the implantation site, the delivery system is operated to push the mitral valve annulus device out. The shape memory function of the metal tube 10 automatically restores the device to a ring-shaped configuration similar to that of a heart valve. The delivery system then pulls the buckle pull line 43, causing the buckle tip 41 to insert into the buckle fixing end 42. The specific structures of the buckle tip 41 and the buckle fixing end 42 automatically lock together, forming a complete annular shape.

[0054] At this point, the delivery system is operated to tighten the shaping guide wire 03, allowing the shaping ring body 01 to be shaped and conform to the surface of the body's native valve leaflets, facilitating the delivery system's insertion of the rivet. During rivet insertion, the rivet pierces the body's native valve leaflets from their lower surface and then passes upward, sequentially through: the native valve leaflets, the lower covering membrane 53, the mesh substrate 52, and the upper covering membrane 53, ultimately securing the extended portion of the covering substrate 02 to the native valve leaflets. The delivery system is then operated to pull the stop pin pull wire 31, removing the stop pin 30. Because the automatically contracting section 11 of the metal tube 10 is pre-shaped like a wave crest or an Ω, after the stop pin 30 is removed, the metal tube 10 automatically rebounds to the wave crest or Ω shape due to its shape memory properties. Simultaneously, the size of the shaping ring body 01 gradually decreases as the metal tube 10 rebounds, and the extended portion of the covering substrate 02 also contracts, pulling the native valve leaflets with the rivets. Finally, the fixing pin retraction line 22 is pulled to retract the fixing pin 20, completing the repair and shaping of the native valve leaflets.

[0055] In summary, this mitral valve annulus contraction device is provided with a metal tube 10 with a shape memory function, the metal tube 10 includes an automatic contraction section 11, the automatic contraction section 11 includes an inner connecting strip 111 and an outer connecting strip 112, a fixing nail 20 is connected between the inner connecting strip 111 and the outer connecting strip 112, the fixing nail 20 is pierced with a stop pin 30, and the stop pin 30 is pierced with a stop pin pull wire 31, the mitral valve annulus contraction device is in a straight line before surgical implantation, and the mitral valve annulus contraction device is released after the input system reaches the implantation position, and the metal tube automatically restores the annular structure similar to the heart valve under the shape memory function, and then the two ends of the metal tube are automatically locked by the snap assembly 10 to form a complete ring; because the automatic contraction section 11 is in its own shape The shape memory function has an automatic contraction function, but due to the presence of the fixing pin 20 and the stop pin 30, the inner connecting strip 111 and the outer connecting strip 112 are locked by the fixing pin 20 and temporarily do not contract; when adjusting the annular shape of the mitral valve annulus contraction device, the stop pin pull line 31 is pulled, the stop pin 30 is pulled out, and the locking of the inner connecting strip 111 and the outer connecting strip 112 by the fixing pin 20 is released, and the inner connecting strip 111 and the outer connecting strip 112 contract under the function of their own shape memory to restore their original shape. During the contraction process, the ring-shaped metal tube will be driven to shrink and become smaller, thereby realizing the adjustment of the annular shape of the metal tube. Compared with the method of using a contraction traction line to adjust the shape of the forming ring in the prior art, the structure is simpler, the production cost is low, and the operation process is convenient.

[0056] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A mitral valve annulus device, characterized in that: include: A shaping ring body (01) comprises a metal tube (10) with a shape memory function, wherein two ends of the metal tube (10) are connected via a snap assembly (40) so that the shaping ring body (01) is connected end to end to form an annular structure; The metal tube (10) is provided with an automatic shrinking section (11), and the automatic shrinking section (11) includes an inner connecting strip (111) and an outer connecting strip (112) located on the inner and outer sides of the forming ring body (01) and not directly connected; the inner connecting strip (111) and the outer connecting strip (112) both have a shape memory function, and a fixing pin (20) is connected between the inner connecting strip (111) and the outer connecting strip (112), and one end of the fixing pin (20) passing through the inner connecting strip (111) is provided with a stop pin (30) blocking one side of the inner connecting strip (111), and a stop pin pull wire (31) is provided on the stop pin (30).

2. The mitral valve annulation device according to claim 1, wherein: A recovery line hole (21) is provided on a side of the fixing nail (20) away from the stop pin (30), and a fixing nail recovery line (22) is passed through the recovery line hole (21).

3. The mitral valve annulation device according to claim 1, wherein: The outer connecting bar (112) is provided with a position-avoiding groove (1121); when the inner connecting bar (111) and the outer connecting bar (112) are fixed by the fixing nail (20), the portion of the inner connecting bar (111) connected to the fixing nail (20) is embedded in the position-avoiding groove (1121).

4. The mitral valve annulation device according to claim 1, wherein: In the axial direction of the annular structure formed by the forming ring body (01), the width of the outer connecting strip (112) is greater than the width of the inner connecting strip (111).

5. The mitral valve annulation device according to claim 1, wherein: After the fixing nail (20) on the automatic shrinking section (11) is pulled out, the inner connecting strip (111) and the outer connecting strip (112) are in a single wave crest shape or a single Ω shape in a natural state, and the convex parts of the inner connecting strip (111) and the outer connecting strip (112) are in the same position and in opposite convex directions.

6. The mitral valve annulation device according to claim 1, characterized in that: After the fixing nail (20) on the automatic shrinking section (11) is pulled out, the inner connecting strip (111) and the outer connecting strip (112) are in a double-peak shape or a double-Ω shape in a natural state, and the two convex parts on the inner connecting strip (111) and the outer connecting strip (112) are in the same position and in opposite convex directions.

7. The mitral valve annulation device according to any one of claims 1 to 6, characterized in that: The metal pipe (10) further comprises a metal pipe section (12) with a rectangular cross section and surrounded on four sides, and the automatic shrinking section (11) is connected between the two metal pipe sections (12).

8. The mitral valve annulation device according to claim 7, characterized in that: The metal tube (10) is made of a memory alloy material, and the metal tube section (12) and the automatic shrinking section (11) are an integrally formed structure.

9. The mitral valve annulation device according to claim 7, characterized in that: A plurality of avoidance notches (121) are provided on the inner side of the metal pipe section (12); the avoidance notches (121) are U-shaped or V-shaped.

10. The mitral valve annulation device according to claim 7, characterized in that: The outer periphery of the metal pipe section (12) is coated with a coating base material (02).

11. The mitral valve annuloplasty device according to any one of claims 1 to 6, characterized in that: A plurality of shaping guide wires (03) are wound around the metal tube (10).

12. The mitral valve annuloplasty device according to any one of claims 1 to 6, characterized in that: The buckle assembly (40) comprises a buckle head end (41) connected to one end of the metal tube (10), and a buckle fixing end (42) connected to the other end of the metal tube (10); the buckle head end (41) is provided with a head end guide head (411), and the buckle fixing end (42) is provided with an accommodating cavity capable of accommodating the head end guide head (411) inside.

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