A heart valve repair device

Abstract

The present invention discloses a heart valve repair device, comprising a shaping ring body and a contraction traction line, wherein the shaping ring body comprises at least two metal strips, an end metal tube sleeved on the end of the metal strip, and a connecting metal tube sleeved between two adjacent metal strips; a first traction hole is provided at one end of the metal strip, and a second traction hole is provided on the connecting metal tube. The contraction traction line is wound around the first traction hole and the second traction hole to connect the metal strip and the connecting metal tube. The two end metal tubes are connected by a snap assembly. By winding the contraction traction line around the first traction hole and the second traction hole to connect the metal strip and the connecting metal tube, and connecting the two end metal tubes by the snap assembly so that the shaping ring body is connected end to end to form an annular structure, such a design has a smaller delivery diameter than a rigid folding shaping ring structure, and the overall strength is only slightly lower than that of a rigid folding structure, but can meet the required support strength.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a heart valve repair 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 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; while the flexible ring has a smaller delivery diameter, but the support and shaping effect are poor, and the recurrence of mitral regurgitation is prone to occur after the operation.

[0005] Therefore, it is necessary to design a mitral annuloplasty 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 the mitral annuloplasty ring in the prior art that it is difficult to have both high support strength and small delivery diameter, thereby providing a heart valve repair device.

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

[0008] A heart valve repair device comprising:

[0009] The forming ring body comprises at least two metal strips, end metal tubes sleeved at the ends of the metal strips, and a connecting metal tube sleeved between two adjacent metal strips; a contraction gap is formed between the connecting metal tube and the end metal tube; the ends of the two adjacent metal strips away from the end metal tubes are both inserted into the inner cavity of the connecting metal tube; a first traction hole is formed on the end of the metal strip away from the end metal tube, and a second traction hole is formed on the connecting metal tube;

[0010] a contraction traction wire, wound around the first traction hole and the second traction hole to connect the metal strip and the joint metal tube, with both ends of the contraction traction wire extending from the second traction hole;

[0011] The two end metal tubes are connected via a snap assembly so that the forming ring bodies are connected end to end to form an annular structure.

[0012] Furthermore, the metal strip and the inner wall of the metal tube of the joint portion are connected via a shrinking locking structure.

[0013] Furthermore, the metal strip is arc-shaped.

[0014] Furthermore, the cross section of the metal strip is rectangular, and the cross sections of the end metal tube and the connecting portion metal tube are also rectangular.

[0015] Furthermore, the ring-shrinking locking structure includes a plurality of slots opened on the metal strip and arranged along the length direction of the metal strip, and a plurality of barbs arranged on the inner wall of the metal tube of the connecting portion and extending into the inner cavity of the metal tube of the connecting portion; the slots and the barbs are engaged with each other.

[0016] Furthermore, the ring-shrinking locking structure includes a plurality of barbs arranged on the outer wall of the metal strip and along the length direction of the metal strip, and a plurality of slots opened on the inner wall of the metal tube of the connection part and extending along the length direction of the metal tube of the connection part; the slots and the barbs are engaged with each other.

[0017] Furthermore, the cross section of the metal strip is circular or elliptical; the cross sections of the end metal tube and the connecting portion metal tube are also circular or elliptical.

[0018] Furthermore, the outer circumference of the metal strip is provided with a plurality of barbs evenly arranged circumferentially, and the wall of the metal tube of the connection portion is provided with a plurality of slots penetrating and circumferentially arranged, and the plurality of barbs and the plurality of slots are engaged with each other in a one-to-one correspondence.

[0019] Furthermore, the outer circumference of the metal strip is provided with a plurality of slots evenly arranged circumferentially, and the inner wall of the metal tube of the connection portion is provided with a plurality of barbs arranged circumferentially, and the plurality of barbs and the plurality of slots are engaged with each other in a one-to-one correspondence.

[0020] Furthermore, there are two metal strips, namely a head end metal strip and a fixed end metal strip; the end metal tube of the head end metal strip close to the buckle assembly is the head end metal tube, and the end metal tube of the fixed end metal strip close to the buckle assembly is the fixed end metal tube; the head end metal strip and the fixed end metal strip are both provided with the first traction hole at one end away from the buckle assembly, and the connecting part metal strip has two second traction holes; there are two contraction traction lines, one of which passes through the first traction hole on the head end metal strip and one of the second traction holes on the connecting part metal strip close to the fixed end metal strip; the other contraction traction line passes through the first traction hole on the fixed end metal strip and another second traction hole on the connecting part metal strip close to the head end metal strip.

[0021] Furthermore, the forming ring body also includes a contraction section metal tube sleeved in the middle of the head end metal strip or the fixed end metal strip.

[0022] Furthermore, a plurality of avoidance gaps are provided on the inner side of the metal tube of the joint portion.

[0023] Furthermore, the avoidance gap is U-shaped or V-shaped.

[0024] Furthermore, a stop pin is provided between the inner and outer side walls of the metal tube of the connecting portion, and the stop pin passes through the metal strip located in the inner cavity of the metal tube of the connecting portion.

[0025] Furthermore, a stop pin pulling hole is provided on the stop pin, and a stop pin pulling wire is passed through the stop pin pulling hole.

[0026] Furthermore, the clip assembly includes a clip fixed end connected to the fixed end metal tube and a clip head end connected to the head end metal tube; the clip head end is provided with a head end guide head, and the head end guide head is provided with a head end traction hole; the clip fixed end is provided with a fixed end traction hole arranged corresponding to the position of the head end guide head and a clip traction line through-hole opened on the tube wall of the clip fixed end and connected with the fixed end traction hole; a clip traction line is passed through between the head end traction hole, the fixed end traction hole and the clip traction line through-hole, and the two ends of the clip traction line extend outward from the clip traction line through-hole.

[0027] Furthermore, an accommodating cavity for accommodating the head end guide head is provided inside the buckle fixing end, and the fixing end traction hole is communicated with the accommodating cavity.

[0028] Furthermore, a concave notch is provided on the inner wall of the accommodating cavity corresponding to the buckle fixing end, and a head end barb is provided on the outer periphery of the head end guide head to engage with the concave notch.

[0029] Furthermore, the head end barb is in the shape of a petal, a rectangle, a pyramid or a fan leaf.

[0030] Furthermore, at least two head end barbs are provided on the outer periphery of the head end guide head.

[0031] Furthermore, the buckle fixing end is a split structure.

[0032] Furthermore, the buckle fixing end is provided with an axial crack on the end surface where the opening of the accommodating cavity is located, which facilitates the head end guide head to be inserted into the accommodating cavity.

[0033] Furthermore, the head end guide head is a double-stage guide head structure, and the accommodating cavity in the buckle fixing end is a double-stage guide accommodating cavity.

[0034] Furthermore, both ends of the head end metal tube are connected to the buckle head end and the head end metal strip through the head end locking pin; both ends of the fixed end metal tube are connected to the buckle fixed end and the fixed end metal strip through the fixed end locking pin.

[0035] Furthermore, the number of the head-end locking pins is 2 or 4, and the number of the fixed-end locking pins is 2 or 4.

[0036] Furthermore, a plurality of shaping guide wires are wound around the metal strip, the end metal tube and the connecting portion metal tube.

[0037] Furthermore, both ends of the head end metal tube are provided with a head end rotary lock cavity, and the buckle head end and the head end metal strip are both provided with a head end rotary lock tongue that cooperates with the head end rotary lock cavity; both ends of the fixed end metal tube are provided with a fixed end rotary lock cavity, and the buckle fixed end and the fixed end metal strip are both provided with a fixed end rotary lock tongue that cooperates with the fixed end rotary lock cavity.

[0038] Furthermore, both ends of the head end metal tube are provided with head end internal threads, and the clip head end and the head end metal strip are both provided with head end external threads that match the head end internal threads; both ends of the fixed end metal tube are provided with fixed end internal threads, and the clip fixed end and the fixed end metal strip are both provided with fixed end external threads that match the fixed end internal threads.

[0039] Furthermore, both ends of the head end metal tube are provided with a head end spring lock cavity, and the buckle head end and the head end metal strip are both provided with a head end spring lock tongue that cooperates with the head end spring lock cavity; both ends of the fixed end metal tube are provided with a fixed end spring lock cavity, and the buckle fixed end and the fixed end metal strip are both provided with a fixed end spring lock tongue that cooperates with the fixed end spring lock cavity.

[0040] Furthermore, the head end metal tube is provided with a head end barb, and the buckle head end and the head end metal strip are provided with a head end barb groove that cooperates with the head end barb; the fixed end metal tube is provided with a fixed end barb, and the buckle fixed end and the fixed end metal strip are provided with a fixed end barb groove that cooperates with the fixed end barb.

[0041] Furthermore, the head end metal tube is provided with a head end barb groove, and the buckle head end and the head end metal strip are provided with head end barbs that cooperate with the head end barb groove; the fixed end metal tube is provided with a fixed end barb groove, and the buckle fixed end and the fixed end metal strip are provided with fixed end barbs that cooperate with the fixed end barb groove.

[0042] Furthermore, the outer surface of the forming ring body is provided with a coating substrate.

[0043] Furthermore, the coating substrate includes a coating section coating the surface of the shaping ring body and an extension section connected to the shaping ring body and extending outward in a direction away from the center of the annular structure formed by the shaping ring body; the extension section of the coating substrate is connected to the body's autologous valve leaflet by implanting rivets.

[0044] Furthermore, the coating substrate includes a soft coating substrate, a mesh substrate coated on the outside of the soft coating substrate, and a coating film coated on the outside of the mesh substrate.

[0045] Furthermore, the coating substrate is a soft coating substrate, and the soft coating substrate is silica gel.

[0046] Furthermore, the coating substrate has multiple sections, and the forming ring body includes multiple sections of metal tubes sleeved on the outer circumference of the metal strip, and each section of the coating substrate is coated on the outer surface of the corresponding metal tube.

[0047] Furthermore, the forming ring body includes multiple sections of metal tubes sleeved on the outer circumference of the metal strip, the coating substrate is annular, and the thickness of the coating substrate covering the metal tube portion is greater than the thickness of the portion not covered with the metal tube.

[0048] Furthermore, the coating substrate is a mesh substrate, and the mesh substrate is a fan-shaped nickel-titanium alloy mesh.

[0049] Furthermore, the number of the nickel-titanium alloy meshes is equal to the number of the soft-coated substrates; one end of the nickel-titanium alloy meshes close to the fan-shaped arc center is wrapped around the surface of the soft-coated substrate, and the other end away from the fan-shaped arc center extends outward to form a fan shape.

[0050] Furthermore, the nickel-titanium alloy mesh includes a soft-coated substrate coating section and a fan-shaped extension section, and the soft-coated substrate coating section and the fan-shaped extension section are connected by a frame-shaped suture fixing ear, and sutures are sewn at the suture fixing ear to sew the nickel-titanium alloy mesh and the soft-coated substrate together.

[0051] Furthermore, the covering film is made of PET film or PET mesh, and the covering film is ring-shaped.

[0052] Furthermore, the coating film includes an upper coating film and a lower coating film.

[0053] The technical solution of the present invention has the following advantages:

[0054] 1. The heart valve repair device provided by the present invention is provided with a shaping ring body, which includes at least two metal strips, end metal tubes sleeved on the ends of the metal strips, and a connecting metal tube sleeved between two adjacent metal strips. A first traction hole is opened at one end of the metal strip away from the end metal tube, and a second traction hole is opened on the connecting metal tube. A contraction traction line is provided, and the contraction traction line is wound around the first traction hole and the second traction hole to connect the metal strip and the connecting metal tube. The two ends of the contraction traction line extend from the second traction hole, and the two end metal tubes are connected by a snap assembly so that the shaping ring body is connected end to end to form a ring structure. With such a design, Compared with the rigid folding forming ring structure, the conveying diameter is smaller and the overall strength is only slightly lower than the rigid folding structure, but it can meet the required support strength; compared with the flexible forming ring, the silicone forming ring has a higher overall support strength; and after the forming ring body is connected by the snap assembly, the shape of the forming ring body can be adjusted by controlling the contraction traction line. Compared with the existing technology in which the forming ring body is self-locked and contracted by the snap assembly, the fault tolerance rate is higher, which avoids the operator's misoperation or exceeding the stroke, resulting in the premature contraction of the forming ring body and irreversible, which directly leads to the failure of the operation, and the operation is more convenient.

[0055] 2. The heart valve repair device provided by the present invention features rectangular cross-sections of the metal strips, end tubes, and commissure tubes. This design not only prevents twisting of the annular ring during implantation, but also reduces the projected area of the annular ring, optimizing its impact on hemodynamics and enhancing the effectiveness of heart valve repair. Furthermore, the presence of long sides in a rectangular cross-section makes it more adaptable to the annular valve than a circular cross-section, providing a larger contact area between the annular valve and the mitral valve during mitral valve replacement.

[0056] 3. The heart valve repair device provided by the present invention is provided with two contraction traction lines. Such a design allows the shaping ring to contract in both directions, while making the contraction more uniform and dispersing the force, thereby protecting human tissue and preventing it from being pulled or torn.

[0057] 4. The heart valve repair device provided by the present invention has a stop pin inserted between the inner and outer walls of the metal tube of the connection part, and the stop pin passes through the metal strip located in the inner cavity of the metal tube of the connection part. Such a design can ensure the stability of the forming ring body, prevent the problem of premature relative sliding between the metal strip and the metal tube of the connection part during the operation, and avoid premature contraction that affects the surgical effect.

[0058] 5. The heart valve repair device provided by the present invention has a double-stage guiding head structure at the head end, and a double-stage guiding accommodating cavity in the buckle fixing end. Such a design can improve the stability of the connection of the shaping ring body.

[0059] 6. The heart valve repair device provided by the present invention comprises a coating substrate comprising a coating section coated on the surface of the forming ring body and an extension section connected to the forming ring body and extending outward in a direction away from the center of the annular structure formed by the forming ring body; the extension section of the coating substrate is connected to the body's own leaflets by implanting rivets. With such a design, the outwardly extending extension section can be used as the base surface for rivet positioning, which is more convenient for driving the rivets. Compared with the traditional method of directly riveting the body to the autologous leaflets through the forming ring body, the required positioning accuracy is lower, avoiding the situation of inaccurate positioning and the need to pull out the anchor to cause repeated damage to the body's own biological tissue.

[0060] 7. The heart valve repair device provided by the present invention has a coating substrate that is a soft coating substrate, and the soft coating substrate is silicone. With this design, the production cost of the forming ring body is lower and the production efficiency is higher. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] 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.

[0062] Figure 1 A three-dimensional structural diagram of the heart valve repair device provided by the present invention;

[0063] Figure 2 Schematic diagram of the positional relationship between the forming ring body and the mesh substrate in this embodiment;

[0064] Figure 3 Schematic diagram of the positional relationship between the forming ring body and the shaping guide wire in this embodiment;

[0065] Figure 4 3D diagram of the forming ring body in this embodiment;

[0066] Figure 5 is a cross-sectional view of the forming ring body in this embodiment;

[0067] Figure 6 Schematic diagram of the connection between the metal strip and the metal tube in this embodiment;

[0068] Figure 7 Schematic diagram of the position relationship of the metal tubes in this embodiment;

[0069] Figure 8 is a cross-sectional view of the buckle assembly in this embodiment;

[0070] Figure 9 3D diagram of the buckle head end in this embodiment;

[0071] Figure 10 This is a three-dimensional exploded view of the buckle head end in this embodiment;

[0072] Figure 11 This is a schematic diagram of the structure of the rectangular head end barb in this embodiment;

[0073] Figure 12 This is a schematic diagram of the structure of the pyramid-shaped head end barb in this embodiment;

[0074] Figure 13 This is a schematic diagram of the structure of the petal-shaped head end barbs in this embodiment;

[0075] Figure 14 This is a schematic diagram of the structure of the fan-shaped head end barb in this embodiment;

[0076] Figure 15Schematic diagram of the structure of the guide head and the accommodating cavity in this embodiment;

[0077] Figure 16 Schematic diagram of the structure of the double-stage guide head and the double-stage guide accommodating cavity in this embodiment;

[0078] Figure 17 is a three-dimensional structural diagram of the metal strip in this embodiment;

[0079] Figure 18 Schematic diagram of the positional relationship between the head end locking pin and the fixed end locking pin in this embodiment;

[0080] Figure 19 Schematic diagram of the structure of the circular head end rotary lock cavity and the head end rotary lock tongue in this embodiment;

[0081] Figure 20 Schematic diagram of the structure of the rectangular head-end rotary lock cavity and the head-end rotary lock tongue in this embodiment;

[0082] Figure 21 Schematic diagram of the structure of the circular head end spring type lock cavity and the head end spring type lock tongue in this embodiment;

[0083] Figure 22 Schematic diagram of the structure of the rectangular head-end spring-type lock cavity and the head-end spring-type lock tongue in this embodiment;

[0084] Figure 23 Schematic diagram of the positional relationship between the soft coating substrate coating section and the fan-shaped extension section in this embodiment;

[0085] Figure 24 Schematic diagram of the positional relationship between the metal tube and the stop pin of the joint portion in this embodiment;

[0086] Figure 25 Schematic diagram of the connection relationship between the rectangular cross-section metal strip and the barb in this embodiment;

[0087] Figure 26 Schematic diagram of the connection relationship between the circular cross-section metal strip and the barb in this embodiment.

[0088] Explanation of reference numerals: 01, forming ring body; 02, covering base material; 03, shaping guide wire; 2, head end metal strip; 3, fixed end metal strip; 4, head end metal tube; 5, fixed end metal tube; 6, joint metal tube; 7, contraction section metal tube; 8, contraction traction wire; 9, stop pin; 901, stop pin pulling hole; 10, buckle assembly; 11, buckle head end; 1101, head end guide head; 1102, head end traction hole; 1103, head end barb; 1104, double-stage guide head; 12, buckle fixed end; 1201, accommodating cavity; 1202, fixed end traction hole; 1203, inner Concave notch; 1204, axial crack; 1205, two-stage guide accommodating cavity; 13, buckle traction line; 14, soft coating substrate; 15, mesh substrate; 1501, soft coating substrate coating section; 1502, fan-shaped extension section; 17, suture fixing ear; 18, head end locking pin; 19, fixed end locking pin;, fixed end barb groove; 24, barb; 25, slot; 26, avoidance notch; 27, first traction hole; 28, second traction hole; 29, head end rotary lock cavity; 30, head end rotary lock tongue; 31, head end spring lock cavity; 32, head end spring lock tongue; 33, spring. DETAILED DESCRIPTION

[0089] 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] like Figure 1-7 A heart valve repair device shown includes a shaping ring body 01 and a contraction traction wire 8. The shaping ring body 01 comprises at least two metal strips, end metal tubes sleeved at the ends of the metal strips, and a connection metal tube 6 sleeved between two adjacent metal strips. A contraction gap is defined between the connection metal tube 6 and the end metal tubes. The ends of the two adjacent metal strips, distal to the end metal tubes, are inserted into the lumen of the connection metal tube 6. A first traction hole 27 is defined at the end of the metal strips distal to the end metal tubes, and a second traction hole 28 is defined in the connection metal tube 6. The contraction traction wire 8 is wound around the first traction hole 27 and the second traction hole 28 to connect the metal strips to the connection metal tube 6. The two ends of the contraction traction wire 8 extend from the second traction hole 28. The two end metal tubes are connected by a snap assembly 10, so that the shaping ring body 01 is connected end to end to form a ring structure.

[0094] This heart valve repair device is provided with a shaping ring body 01, which includes at least two metal strips, end metal tubes sleeved at the ends of the metal strips, and a connecting metal tube 6 sleeved between two adjacent metal strips. A first traction hole 27 is provided at one end of the metal strip away from the end metal tube, and a second traction hole 28 is provided on the connecting metal tube 6. A contraction traction line 8 is provided and is wound around the first traction hole 27 and the second traction hole 28 to connect the metal strip and the connecting metal tube 6. The two ends of the contraction traction line 8 extend from the second traction hole 28. The two end metal tubes are connected by a snap assembly 10, so that the shaping ring body 01 is connected end to end to form a ring. The structure is designed in this way. Compared with the rigid folding forming ring structure, the conveying diameter is smaller and the overall strength is only slightly lower than the rigid folding structure, but it can meet the required support strength; compared with the silicone forming ring of the flexible forming ring, the overall support strength is higher; and after the forming ring body is connected through the snap assembly, the shape of the forming ring body can be adjusted by controlling the contraction traction line. Compared with the existing technology in which the forming ring body is self-locked and contracted by the snap assembly, the fault tolerance rate is higher, which avoids the operator's misoperation or exceeding the stroke, resulting in the premature contraction of the forming ring body and irreversible, which directly leads to the failure of the operation, and the operation is more convenient.

[0095] In this embodiment, there are two metal strips, namely a head end metal strip 2 and a fixed end metal strip 3; the end metal tube sleeved on one end of the head end metal strip 2 close to the snap assembly 10 is the head end metal tube 4, and the end metal tube sleeved on one end of the fixed end metal strip 3 close to the snap assembly 10 is the fixed end metal tube 5.

[0096] In this embodiment, the metal tubes on the forming ring body 01 also include a contraction section metal tube 7 that is sleeved over the head end metal strip 2 or the middle portion of the fixed end metal strip 3. Several shaping guide wires 03 are wound around both the metal strip and the connecting section metal tube 6. Specifically, the shaping guide wires 03 on the metal strip are located between the end metal tube and the contraction section metal tube 7.

[0097] like Figure 7 As shown, in this embodiment, a plurality of avoidance gaps are provided on the inner side of the metal tube 6 of the connection part. Specifically, the avoidance gaps are U-shaped or V-shaped. A stop pin 9 is provided between the inner and outer side walls of the metal tube 6 of the connection part, and the stop pin 9 passes through the metal strip located in the inner cavity of the metal tube 6 of the connection part. Specifically, a stop pin pulling hole 901 is provided on the stop pin 9, and a stop pin pulling line is provided in the stop pin pulling hole 901. The design of the stop pin 9 can ensure the stability of the forming ring body 01, prevent the problem of premature relative sliding between the metal strip and the metal tube 6 of the connection part during the operation, and avoid premature contraction that affects the surgical effect.

[0098] like Figure 18 and Figure 25 As shown, in this embodiment, the metal strip and the inner wall of the metal tube 6 of the joint are connected by a ring-shrinking locking structure. Specifically, the metal strip is arc-shaped, and the cross-sections of the metal strip, the end metal tube and the metal tube 6 of the joint are all rectangular; the ring-shrinking locking structure includes a plurality of slots 25 provided on the metal strip and arranged along the length direction of the metal strip, and a plurality of barbs 24 provided in the inner cavity of the metal tube 6 of the joint, and the slots 25 and the barbs 24 are engaged with each other. Such a design can not only avoid twisting of the shaping ring during implantation, but also reduce the projected area of the shaping ring body 01, optimize the effect 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, and compared with the circular cross-section, it is more suitable for the ring-valve, and can provide the ring-valve of mitral valve replacement with a larger contact area.

[0099] Specifically, such as Figure 5 and Figure 17 As shown, a plurality of barbs 24 are disposed on opposite sides of the metal tube lumen, with staggered spacing provided between the barbs 24. This design allows the barbs 24 to be arranged asymmetrically, improving space utilization while avoiding the problem of looseness and resulting in false hooks in a symmetrical arrangement.

[0100] In an alternative embodiment, the ring-shrinking locking structure includes a plurality of barbs 24 arranged on the outer wall of the metal strip and along the length direction of the metal strip, and a plurality of slots 25 opened on the inner wall of the metal tube 6 of the connection part and extending along the length direction of the metal tube 6 of the connection part; the slots 25 and the barbs 24 are engaged with each other.

[0101] In an alternative embodiment, as Figure 26 As shown, the cross-sections of the metal strip, the end metal tubes, and the connecting portion metal tube 6 are all circular or elliptical. The outer circumference of the metal strip is provided with a plurality of barbs 24 evenly spaced circumferentially, and the wall of the connecting portion metal tube 6 is provided with a plurality of slots 25 extending through and circumferentially disposed therein. The barbs 24 and the slots 25 engage in a one-to-one correspondence. In an alternative embodiment, the outer circumference of the metal strip is provided with a plurality of slots 25 evenly spaced circumferentially, and the inner wall of the connecting portion metal tube 6 is provided with a plurality of barbs 24 disposed circumferentially therein. The barbs 24 and the slots 25 engage in a one-to-one correspondence.

[0102] In a replaceable embodiment, the head end metal tube 4 is provided with a head end barb, and the snap head end 11 and the head end metal strip 2 are provided with a head end barb groove that matches the head end barb; the fixed end metal tube 5 is provided with a fixed end barb, and the snap fixed end 12 and the fixed end metal strip 3 are provided with a fixed end barb groove that matches the fixed end barb.

[0103] In a replaceable embodiment, the head end metal tube 4 is provided with a head end barb groove, and the snap head end 11 and the head end metal strip 2 are provided with head end barbs that cooperate with the head end barb groove; the fixed end metal tube 5 is provided with a fixed end barb groove, and the snap fixed end 12 and the fixed end metal strip 3 are provided with fixed end barbs that cooperate with the fixed end barb groove.

[0104] In an alternative embodiment, as Figure 19-20 As shown, both ends of the head end metal tube 4 are provided with a head end rotary lock cavity 29, and the snap head end 11 and the head end metal strip 2 are provided with a head end rotary lock tongue 30 that cooperates with the head end rotary lock cavity 29; both ends of the fixed end metal tube 5 are provided with a fixed end rotary lock cavity, and the snap fixed end 12 and the fixed end metal strip 3 are provided with a fixed end rotary lock tongue that cooperates with the fixed end rotary lock cavity.

[0105] In a replaceable embodiment, as shown in Figure -, both ends of the head end metal tube 4 are provided with a head end spring lock cavity 31, and the snap head end 11 and the head end metal strip 2 are both provided with a head end spring lock tongue 32 that cooperates with the head end spring lock cavity 31; both ends of the fixed end metal tube 5 are provided with a fixed end spring lock cavity, and the snap fixed end 12 and the fixed end metal strip 3 are both provided with a fixed end spring lock tongue that cooperates with the fixed end spring lock cavity.

[0106] In a replaceable embodiment, both ends of the head end metal tube 4 are provided with head end internal threads, and the snap head end 11 and the head end metal strip 2 are both provided with head end external threads that match the head end internal threads; both ends of the fixed end metal tube 5 are provided with fixed end internal threads, and the snap fixed end 12 and the fixed end metal strip 3 are both provided with fixed end external threads that match the fixed end internal threads.

[0107] like Figure 6 、 Figure 7 and Figure 17 As shown, in this embodiment, a first traction hole 27 is provided at the end of the head end metal strip 2 and the fixed end metal strip 3 away from the buckle assembly 10, and two second traction holes 28 are provided on the connecting part metal tube 6; there are two contraction traction lines 8, one of which passes through the first traction hole 27 on the head end metal strip 2 and a second traction hole 28 on the connecting part metal tube 6 close to the fixed end metal strip 3; the other contraction traction line 8 passes through the first traction hole 27 on the fixed end metal strip 3 and another second traction hole 28 on the connecting part metal tube 6 close to the head end metal strip 2.

[0108] In this embodiment, the clip assembly 10 is connected between the fixed end metal tube 5 and the head end metal tube 4. The clip assembly 10 includes a clip fixed end 12 connected to the fixed end metal tube 5 and a clip head end 11 connected to the head end metal tube 4. Specifically, the clip head end 11 is provided with a head end guide head 1101, and the head end guide head 1101 is provided with a head end traction hole 1102. The clip fixed end 12 is an integrated structure, provided with a fixed end traction hole 1202 corresponding to the position of the head end guide head 1101 and a clip traction line through-hole provided on the tube wall of the clip fixed end 12 and connected to the fixed end traction hole 1202; a clip traction line 13 is passed through between the head end traction hole 1102, the fixed end traction hole 1202 and the clip traction line through-hole, and the two ends of the clip traction line 13 extend outward from the clip traction line through-hole.

[0109] like Figure 11-14 As shown, in this embodiment, the interior of the clip fixing end 12 is provided with a receiving cavity 1201 that can accommodate the head end guide head 1101, and the fixed end pulling hole 1202 is connected to the receiving cavity 1201. A concave notch 1203 is provided on the inner wall of the clip fixing end 12 corresponding to the receiving cavity 1201. The outer periphery of the head end guide head 1101 is provided with four head end barbs 1103 that engage with the concave notches 1203. Specifically, the head end barbs 1103 are shaped like petals, rectangles, pyramids, or fan blades. In alternative embodiments, the number of head end barbs 1103 can also be set to five or six.

[0110] In an alternative embodiment, as Figure 10 As shown, the buckle fixing end 12 can also be set as a split structure, so that the buckle fixing end 12 is easier to process.

[0111] In an alternative embodiment, as Figure 15 As shown, the buckle fixing end 12 is provided with an axial crack 1204 on the end surface where the opening of the accommodating cavity 1201 is located, so as to facilitate the insertion of the head end guide head 1101 into the accommodating cavity 1201.

[0112] In an alternative embodiment, as Figure 16 As shown, the head end guide head 1101 is a double-stage guide head 1104 structure, and the accommodating cavity 1201 in the buckle fixing end 12 is a double-stage guide accommodating cavity 1205. Such a design can improve the stability of the connection of the forming ring body 01.

[0113] like Figure 18 As shown, in this embodiment, both ends of the head-end metal tube 4 are connected to the buckle head end 11 and the head-end metal strip 2, respectively, via head-end locking pins 18; and both ends of the fixed-end metal tube 5 are connected to the buckle fixed end 12 and the fixed-end metal strip 3, respectively, via fixed-end locking pins 19. There are four head-end locking pins 18 and four fixed-end locking pins 19.

[0114] like Figure 2 As shown, in this embodiment, the coating substrate 02 includes a soft coating substrate 14, a mesh substrate 15 covering the outside of the soft coating substrate 14, and a coating film covering the outside of the mesh substrate 15. Specifically, the coating substrate 02 is the soft coating substrate 14, which is made of silicone; the coating substrate 02 is the mesh substrate 15, which is a fan-shaped nickel-titanium alloy mesh. The coating film is made of PET film or PET mesh and is annular. Using silicone material to make the soft coating substrate 14 can reduce the production cost of the forming ring body 01 and improve production efficiency.

[0115] In this embodiment, the coating substrate 02 is coated on the outer surface of the shaping ring body 01. Specifically, the coating substrate 02 includes a coating segment coated on the surface of the shaping ring body 01 and an extension segment connected to the shaping ring body 01 and extending outward in the direction of the center of the annular structure formed away from the shaping ring body 01. The extension segment of the coating substrate 02 is connected to the body's own valve leaflets by implanting rivets. With this design, the outwardly extending extension segment can be used as the base surface for rivet positioning, which is more convenient when driving the rivet. Compared with the traditional method of directly riveting the body 01 to the autologous valve leaflets, the required positioning accuracy is lower, avoiding the situation of inaccurate positioning and the need to pull out the anchor, which causes repeated damage to the body's own biological tissue.

[0116] In this embodiment, the cladding substrate 02 is provided in multiple sections on the forming ring body 01, and is respectively coated on the outer surfaces of the head end metal tube 4, the fixed end metal tube 5, the connecting portion metal tube 6, and the constricted section metal tube 7. Specifically, the cladding substrate 02 is annular, and the thickness of the cladding substrate 02 covering the metal tubes is greater than the thickness of the uncoated portions.

[0117] like Figure 2 、 Figure 23As shown, in this embodiment, the number of nickel-titanium alloy meshes is equal to the number of soft coating substrates 14. The end of the nickel-titanium alloy mesh near the fan-shaped arc center is wrapped around the surface of the soft coating substrate 14, and the end away from the fan-shaped arc center extends outward to form a fan-shaped surface. Specifically, the nickel-titanium alloy mesh includes a soft coating substrate sheathing section 1501 and a fan-shaped extension section 1502. The soft coating substrate sheathing section 1501 and the fan-shaped extension section 1502 are connected by a frame-shaped suture fixing ear 17. Sutures are sewn at the suture fixing ear 17 to sew the nickel-titanium alloy mesh to the soft coating substrate 14. In an alternative embodiment, the coating film includes an upper coating film and a lower coating film.

[0118] In summary, this heart valve repair device is provided with a shaping ring body 01, which includes at least two metal strips, end metal tubes sleeved at the ends of the metal strips, and a connecting metal tube 6 sleeved between two adjacent metal strips. A first traction hole 27 is provided at one end of the metal strip away from the end metal tube, and a second traction hole 28 is provided on the connecting metal tube 6. A contraction traction line 8 is provided, and the contraction traction line 8 is wound around the first traction hole 27 and the second traction hole 28 to connect the metal strip and the connecting metal tube 6. The two ends of the contraction traction line 8 extend from the second traction hole 28, and the two end metal tubes are connected by a snap assembly 10, so that the shaping ring body 01 is connected end to end to form a The annular structure is designed in this way. Compared with the rigid folding forming ring structure, the conveying diameter is smaller and the overall strength is only slightly lower than the rigid folding structure, but it can meet the required support strength; compared with the silicone forming ring of the flexible forming ring, the overall support strength is higher; and after the forming ring body is connected through the snap assembly, the shape of the forming ring body can be adjusted by controlling the contraction traction line. Compared with the existing technology in which the forming ring body is self-locking and contracted by the snap assembly, the fault tolerance rate is higher, avoiding the operator's misoperation or exceeding the stroke, resulting in the premature contraction of the forming ring body and irreversible, which directly leads to the failure of the operation, and the operation is more convenient.

[0119] 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 heart valve repair device, characterized in that: include: The forming ring body (01) comprises two metal strips, an end metal tube sleeved at the ends of the metal strips, and a connecting metal tube (6) sleeved between two adjacent metal strips, wherein the two metal strips are respectively a head end metal strip (2) and a fixed end metal strip (3); a shrinkage gap is provided between the connecting metal tube (6) and the end metal tube; the ends of the two adjacent metal strips away from the end metal tubes are both inserted into the inner cavity of the connecting metal tube (6); a first traction hole (27) is provided at the end of the metal strip away from the end metal tube, and a second traction hole (28) is provided on the connecting metal tube (6); A contraction traction line (8) is wound around the first traction hole (27) and the second traction hole (28) to connect the metal bar and the connecting portion metal tube (6), and the two ends of the contraction traction line (8) extend from the second traction hole (28); there are two contraction traction lines (8), one of which passes through the first traction hole (27) on the head end metal bar (2) and the second traction hole (28) on the connecting portion metal tube (6) close to the fixed end metal bar (3); the other contraction traction line (8) passes through the first traction hole (27) on the fixed end metal bar (3) and the other second traction hole (28) on the connecting portion metal tube (6) close to the head end metal bar (2); A stop pin (9) is provided between the inner and outer walls of the connecting portion metal tube (6), and the stop pin (9) passes through the metal strip located in the inner cavity of the connecting portion metal tube (6); The two end metal tubes are connected via a snap assembly (10) so that the forming ring body (01) is connected end to end to form an annular structure.

2. The heart valve repair device according to claim 1, characterized in that: The metal strip and the inner wall of the joint metal tube (6) are connected via a shrinking locking structure.

3. The heart valve repair device according to claim 2, characterized in that: The metal strip is arc-shaped.

4. The heart valve repair device according to claim 3, characterized in that: The cross section of the metal strip is rectangular, and the cross sections of the end metal tube and the connecting portion metal tube (6) are also rectangular.

5. The heart valve repair device according to claim 4, characterized in that: The ring-shrinking locking structure comprises a plurality of slots (25) provided on the metal strip and arranged along the length direction of the metal strip, and a plurality of barbs (24) provided on the inner wall of the connecting portion metal tube (6) and extending into the inner cavity of the connecting portion metal tube (6); the slots (25) and the barbs (24) are engaged with each other.

6. The heart valve repair device according to claim 4, characterized in that: The ring-shrinking locking structure comprises a plurality of barbs (24) arranged on the outer wall of the metal strip and arranged along the length direction of the metal strip, and a plurality of slots (25) provided on the inner wall of the connecting portion metal tube (6) and extending along the length direction of the connecting portion metal tube (6); the slots (25) and the barbs (24) are engaged with each other.

7. The heart valve repair device according to claim 3, characterized in that: The cross section of the metal strip is circular or elliptical; the cross sections of the end metal tube and the connecting portion metal tube (6) are also circular or elliptical.

8. The heart valve repair device according to claim 7, characterized in that: The outer periphery of the metal strip is provided with a plurality of barbs (24) evenly arranged in the circumferential direction, and the wall of the metal tube (6) of the connecting portion is provided with a plurality of slots (25) penetrating and arranged in the circumferential direction, and the plurality of barbs (24) and the plurality of slots (25) are engaged in a one-to-one correspondence.

9. The heart valve repair device according to claim 7, characterized in that: The outer periphery of the metal strip is provided with a plurality of slots (25) evenly arranged in the circumferential direction, and the inner wall of the metal tube (6) of the connecting portion is provided with a plurality of barbs (24) arranged in the circumferential direction, and the plurality of barbs (24) and the plurality of slots (25) are engaged in a one-to-one correspondence.

10. The heart valve repair device according to any one of claims 1 to 9, characterized in that: The end metal tube sleeved on one end of the head end metal strip (2) close to the buckle assembly (10) is the head end metal tube (4), and the end metal tube sleeved on one end of the fixed end metal strip (3) close to the buckle assembly (10) is the fixed end metal tube (5); the ends of the head end metal strip (2) and the fixed end metal strip (3) away from the buckle assembly (10) are both provided with the first traction hole (27), and the connecting portion metal tube (6) is provided with two second traction holes (28).

11. The heart valve repair device according to claim 10, characterized in that: The forming ring body (01) further comprises a contraction section metal tube (7) sleeved in the middle of the head end metal strip (2) or the fixed end metal strip (3).

12. The heart valve repair device according to claim 1, characterized in that: A plurality of avoidance notches are provided on the inner side of the joint metal tube (6).

13. The heart valve repair device according to claim 12, characterized in that: The avoidance gap is U-shaped or V-shaped.

14. The heart valve repair device according to claim 1, characterized in that: A stop pin (9) pulling hole is provided on the stop pin (9), and a stop pin (9) pulling wire is passed through the stop pin (9) pulling hole.

15. The heart valve repair device according to claim 10, characterized in that: The buckle assembly (10) comprises a buckle fixed end (12) connected to the fixed end metal tube (5) and a buckle head end (11) connected to the head end metal tube (4); the buckle head end (11) is provided with a head end guide head (1101), and the head end guide head (1101) is provided with a head end traction hole (1102); the buckle fixed end (12) is provided with a fixed end traction hole (1202) corresponding to the position of the head end guide head (1101) and a buckle traction line through-hole provided on the tube wall of the buckle fixed end (12) and connected to the fixed end traction hole (1202); a buckle traction line (13) is passed through between the head end traction hole (1102), the fixed end traction hole (1202) and the buckle traction line through-hole, and two ends of the buckle traction line (13) extend outward from the buckle traction line through-hole.

16. The heart valve repair device according to claim 15, characterized in that: An accommodating cavity (1201) capable of accommodating the head end guide head (1101) is provided inside the buckle fixing end (12), and the fixing end traction hole (1202) is communicated with the accommodating cavity (1201).

17. The heart valve repair device according to claim 16, characterized in that: The buckle fixing end (12) is provided with an inner concave notch (1203) on the inner wall corresponding to the accommodating cavity (1201), and the outer periphery of the head end guide head (1101) is provided with a head end barb (1103) that engages with the inner concave notch (1203).

18. The heart valve repair device according to claim 17, characterized in that: The head end barb (1103) is in the shape of a petal, a rectangle, a pyramid or a fan leaf.

19. The heart valve repair device according to claim 17, characterized in that: At least two head end barbs (1103) are provided on the outer periphery of the head end guide head (1101).

20. The heart valve repair device according to claim 15, characterized in that: The buckle fixing end (12) is a split structure.

21. The heart valve repair device according to claim 16, characterized in that: The buckle fixing end (12) is provided with an axial crack (1204) on the end surface where the opening of the accommodating cavity (1201) is located, which facilitates the insertion of the head end guide head (1101) into the accommodating cavity (1201).

22. The heart valve repair device according to claim 21, characterized in that: The head end guide head (1101) is a double-stage guide head (1104) structure, and the accommodating cavity (1201) in the buckle fixing end (12) is a double-stage guide accommodating cavity (1205).

23. The heart valve repair device according to claim 15, characterized in that: Both ends of the head end metal tube (4) are connected to the buckle head end (11) and the head end metal strip (2) through a head end locking pin (18); and both ends of the fixed end metal tube (5) are connected to the buckle fixed end (12) and the fixed end metal strip (3) through a fixed end locking pin (19).

24. The heart valve repair device according to claim 23, characterized in that: The number of the head end locking pins (18) is 2 or 4, and the number of the fixed end locking pins (19) is 2 or 4.

25. The heart valve repair device according to claim 1, characterized in that: A plurality of shaping guide wires (03) are wound around the metal strip, the end metal tube and the connection metal tube (6).

26. The heart valve repair device according to claim 15, characterized in that Both ends of the head end metal tube (4) are provided with a head end rotary lock cavity (29), and both the buckle head end (11) and the head end metal strip (2) are provided with a head end rotary lock tongue (30) that matches the head end rotary lock cavity (29); both ends of the fixed end metal tube (5) are provided with a fixed end rotary lock cavity, and both the buckle fixed end (12) and the fixed end metal strip (3) are provided with a fixed end rotary lock tongue that matches the fixed end rotary lock cavity.

27. The heart valve repair device according to claim 15, characterized in that Both ends of the head end metal tube (4) are provided with head end internal threads, and the snap head end (11) and the head end metal strip (2) are provided with head end external threads that match the head end internal threads; both ends of the fixed end metal tube (5) are provided with fixed end internal threads, and the snap fixed end (12) and the fixed end metal strip (3) are provided with fixed end external threads that match the fixed end internal threads.

28. The heart valve repair device according to claim 15, characterized in that Both ends of the head end metal tube (4) are provided with a head end spring type lock cavity (31), and the buckle head end (11) and the head end metal strip (2) are provided with a head end spring type lock tongue (32) that matches the head end spring type lock cavity (31); both ends of the fixed end metal tube (5) are provided with a fixed end spring type lock cavity, and the buckle fixed end (12) and the fixed end metal strip (3) are provided with a fixed end spring type lock tongue that matches the fixed end spring type lock cavity.

29. The heart valve repair device according to claim 16, wherein: The head end metal tube (4) is provided with a head end barb, and the buckle head end (11) and the head end metal strip (2) are provided with a head end barb groove that matches the head end barb; the fixed end metal tube (5) is provided with a fixed end barb, and the buckle fixed end (12) and the fixed end metal strip (3) are provided with a fixed end barb groove that matches the fixed end barb.

30. The heart valve repair device according to claim 15, characterized in that: The head end metal tube (4) is provided with a head end barb groove, and the buckle head end (11) and the head end metal strip (2) are provided with head end barbs that match the head end barb groove; the fixed end metal tube (5) is provided with a fixed end barb groove, and the buckle fixed end (12) and the fixed end metal strip (3) are provided with fixed end barbs that match the fixed end barb groove.

31. The heart valve repair device according to claim 1, characterized in that The outer surface of the forming ring body (01) is provided with a coating substrate (02).

32. The heart valve repair device according to claim 31, characterized in that: The coating substrate (02) comprises a coating section coating the surface of the shaping ring body (01) and an extension section connected to the shaping ring body (01) and extending outward in a direction away from the center of the annular structure formed by the shaping ring body (01); the extension section of the coating substrate (02) is connected to the body's own valve leaflet by implanting rivets.

33. The heart valve repair device according to claim 31, characterized in that: The coating substrate (02) comprises a soft coating substrate (14), a mesh substrate (15) coated outside the soft coating substrate (14), and a coating film coated outside the mesh substrate (15).

34. The heart valve repair device according to claim 33, characterized in that: The soft coating substrate (14) is silica gel.

35. The heart valve repair device according to claim 34, characterized in that: The coating substrate (02) has multiple sections, and the forming ring body (01) includes multiple sections of metal tubes sleeved on the outer periphery of the metal strip, and each section of the coating substrate (02) is coated on the outer surface of the corresponding metal tube.

36. The heart valve repair device according to claim 34, characterized in that The forming ring body (01) comprises a plurality of sections of metal tubes sleeved on the outer periphery of the metal strip, the coating substrate (02) is annular, and the thickness of the coating substrate (02) coating the metal tube portion is greater than the thickness of the portion not coated with the metal tube.

37. The heart valve repair device according to claim 35, characterized in that: The mesh substrate (15) is a fan-shaped nickel-titanium alloy mesh.

38. The heart valve repair device according to claim 37, characterized in that: The number of the nickel-titanium alloy meshes is equal to the number of the soft coating substrates (14); one end of the nickel-titanium alloy meshes close to the fan-shaped arc center is wrapped around the surface of the soft coating substrate (14), and the other end away from the fan-shaped arc center extends outward to form a fan shape.

39. The heart valve repair device according to claim 38, characterized in that: The nickel-titanium alloy mesh comprises a soft-coated substrate coating section (1501) and a fan-shaped extension section (1502); the soft-coated substrate coating section (1501) and the fan-shaped extension section (1502) are connected via a frame-shaped suture fixing ear (17); sutures are sewn at the suture fixing ear (17) to suture the nickel-titanium alloy mesh and the soft-coated substrate (14) together.

40. The heart valve repair device according to claim 33, wherein: The covering film is made of PET film or PET mesh, and the covering film is ring-shaped.

41. The heart valve repair device according to claim 40, characterized in that: The covering film includes an upper covering film and a lower covering film.

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