A form-locking structure for a heart valve repair device

Abstract

The present invention discloses a forming and locking structure for a heart valve repair device, comprising a forming ring body and a buckle structure connected to the front and rear ends of the forming ring body to form the forming ring body into an annular shape; the buckle structure comprises a buckle fixed end and a buckle head end connected to opposite ends of the forming ring body; the buckle 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 buckle fixed end is provided with a fixed end traction hole and a buckle traction line through-hole provided on the tube wall of the buckle fixed end; a buckle traction line is passed through between the head end traction hole, the fixed end traction hole, and the buckle traction line through-hole, and the two ends of the buckle traction line extend outward from the buckle traction line through-hole. By pulling the two ends of the buckle traction line extending outward from the buckle traction line through-hole, the buckle head end and the buckle fixed end are driven to engage, thereby achieving the tail locking of the forming ring body and preventing the forming ring body from shrinking when locked.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a forming and locking structure of 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] Existing mitral valve shaping rings generally use a snap assembly to achieve both the end locking of the shaping ring body and the contraction of the shaping ring through the snap assembly. The fault tolerance rate is low. Once the operator makes an error in operation or exceeds the stroke, the shaping ring will be contracted prematurely. Since the snap assembly generally adopts a self-locking structure, this behavior is irreversible, which directly leads to the failure of the operation. Summary of the Invention

[0005] Therefore, the technical problem to be solved by the present invention is to overcome the defect of the snap-fit structure of the mitral valve shaping ring in the prior art that it is necessary to achieve both the end locking of the shaping ring body and the contraction of the shaping ring, which is prone to causing operational errors, thereby providing a shaping locking structure for a heart valve repair device.

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

[0007] A forming locking structure of a heart valve repair device includes a forming ring body and a snap structure connected to the head and tail ends of the forming ring body to make the forming ring body annular; the snap structure includes a snap fixing end and a snap head end connected to the opposite ends of the forming ring body; the snap 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 snap fixing end is provided with a fixed end traction hole arranged corresponding to the position of the head end guide head and a snap traction line through-hole provided on the tube wall of the snap fixing end and connected with the fixed end traction hole; a snap traction line is passed through between the head end traction hole, the fixed end traction hole and the snap traction line through-hole, and the two ends of the snap traction line extend outward from the snap traction line through-hole.

[0008] 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.

[0009] 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.

[0010] Furthermore, the head end barb is in the shape of a petal, a rectangle, a pyramid or a fan leaf.

[0011] Furthermore, at least two head end barbs are provided on the outer periphery of the head end guide head.

[0012] Furthermore, the buckle fixing end is a split structure.

[0013] 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.

[0014] 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.

[0015] Furthermore, the forming ring body includes a head end metal bar, a fixed end metal bar, a head end metal tube sleeved on one end of the head end metal bar close to the snap structure, a fixed end metal tube sleeved on one end of the fixed end metal bar close to the snap structure, and a connecting part metal tube sleeved between the head end metal bar and the fixed end metal bar; the ends of the head end metal bar and the fixed end metal bar away from the end metal tube are both inserted into the inner cavity of the connecting part metal tube; the head end metal bar and the connecting part metal tube, as well as the fixed end metal bar and the connecting part metal tube are all connected by a ring shrinkage locking structure.

[0016] Furthermore, the head end metal bar and the fixed end metal bar are both provided with a first traction hole at one end away from the buckle assembly, and the connecting part metal tube is provided with two second traction holes; it also includes two contraction traction lines, one of which passes through the first traction hole on the head end metal bar and one of the second traction holes on the connecting part metal tube close to the fixed end metal bar; the other contraction traction line passes through the first traction hole on the fixed end metal bar and another of the second traction holes on the connecting part metal tube close to the head end metal bar.

[0017] Furthermore, the head end metal bar and the fixed end metal bar are both arc-shaped, and their cross sections are rectangular; the end metal tube and the connecting portion metal tube also have rectangular cross sections.

[0018] Furthermore, a plurality of avoidance gaps are provided on the inner side of the metal tube of the joint portion.

[0019] Furthermore, the two sides 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; the two cars 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.

[0020] The technical solution of the present invention has the following advantages:

[0021] 1. The forming locking structure of the heart valve repair device provided by the present invention is characterized in that a forming ring body is provided, and a snap structure is connected at both ends of the forming ring body so that the forming ring body is annular. The snap structure includes a snap fixing end and a snap head end connected to the opposite ends of the forming ring body, a head end traction hole is provided on the snap head end, a fixed end traction hole is provided on the snap fixing end, a snap traction line through-hole connected to the fixed end traction hole is provided on the tube wall of the snap fixing end, a snap traction line is passed through between the fixed end traction hole and the snap traction line through-hole, so that the two ends of the snap traction line extend outward from the snap traction line through-hole, and the snap traction line is pulled to drive the snap head end and the snap fixing end to engage, thereby realizing the tail locking of the forming ring body, avoiding the shrinkage of the forming ring body when locking, and reducing operational errors.

[0022] 2. The forming and locking structure of the heart valve repair device provided by the present invention features rectangular cross-sections of the metal strip, end metal tube, and commissure metal tube. This design not only prevents twisting of the forming ring during implantation, but also reduces the projected area of the forming ring itself, optimizing its impact on hemodynamics and improving the effectiveness of heart valve repair. Furthermore, due to the presence of long sides, the rectangular cross-section better fits the annulus-in-valve compared to a circular cross-section, providing a larger contact area between the annulus-in-valve during mitral valve replacement.

[0023] 3. The forming locking structure of the heart valve repair device provided by the present invention is provided with two contraction traction lines. Such a design allows the forming 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 off or torn.

[0024] 5. The forming locking structure of 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 forming ring body. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] 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.

[0026] Figure 1 A three-dimensional structural diagram of the formed locking structure of the heart valve repair device provided by the present invention;

[0027] Figure 2 Schematic diagram of the positional relationship between the forming ring body and the mesh substrate in this embodiment;

[0028] Figure 3 Schematic diagram of the positional relationship between the forming ring body and the shaping guide wire in this embodiment;

[0029] Figure 4 3D diagram of the forming ring body in this embodiment;

[0030] Figure 5 is a cross-sectional view of the forming ring body in this embodiment;

[0031] Figure 6 Schematic diagram of the connection between the metal strip and the metal tube in this embodiment;

[0032] Figure 7 Schematic diagram of the position relationship of the metal tubes in this embodiment;

[0033] Figure 8 is a cross-sectional view of the buckle assembly in this embodiment;

[0034] Figure 9 3D diagram of the buckle head end in this embodiment;

[0035] Figure 10 This is a three-dimensional exploded view of the buckle head end in this embodiment;

[0036] Figure 11This is a schematic diagram of the structure of the rectangular head end barb in this embodiment;

[0037] Figure 12 This is a schematic diagram of the structure of the pyramid-shaped head end barb in this embodiment;

[0038] Figure 13 This is a schematic diagram of the structure of the petal-shaped head end barbs in this embodiment;

[0039] Figure 14 This is a schematic diagram of the structure of the fan-shaped head end barb in this embodiment;

[0040] Figure 15 Schematic diagram of the structure of the guide head and the accommodating cavity in this embodiment;

[0041] Figure 16 Schematic diagram of the structure of the double-stage guide head and the double-stage guide accommodating cavity in this embodiment;

[0042] Figure 17 is a three-dimensional structural diagram of the metal strip in this embodiment;

[0043] Figure 18 Schematic diagram of the positional relationship between the head end locking pin and the fixed end locking pin in this embodiment;

[0044] 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;

[0045] 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;

[0046] 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;

[0047] 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;

[0048] Figure 23 Schematic diagram of the positional relationship between the soft coating substrate coating section and the fan-shaped extension section in this embodiment;

[0049] Figure 24 Schematic diagram of the positional relationship between the metal tube and the stop pin of the joint portion in this embodiment;

[0050] Figure 25 Schematic diagram of the connection relationship between the rectangular cross-section metal strip and the barb in this embodiment;

[0051] Figure 26 Schematic diagram of the connection relationship between the circular cross-section metal strip and the barb in this embodiment.

[0052] Explanation of the reference numerals: 01, forming ring body; 02, coating 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, snap assembly; 11, snap head end; 1101, head end guide head; 1102, head end traction hole; 1103, head end barb; 1104, double-stage guide head; 12, snap fixed end; 1201, accommodating cavity; 1202, fixed end traction hole; 1203, concave notch; 1204, axial crack; 1205, double-stage guide container Receiving cavity; 1206, clip traction line passing hole; 13, clip traction line; 14, soft coating substrate; 15, mesh substrate; 1501, soft coating substrate coating section; 1502, fan-shaped extension section; 16, coating film; 17, suture fixing ear; 18, head end locking pin; 19, fixed end locking pin; 20, head end barb; 21, head end barb groove; 22, fixed end barb; 23, 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

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] like Figure 1-7 The forming locking structure of a heart valve repair device shown includes a forming ring body 01 and a snap structure connected to the head and tail ends of the forming ring body 01 to make the forming ring body 01 annular; the snap structure includes a snap fixing end 12 and a snap head end 11 connected to the opposite ends of the forming ring body 01; the snap 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 snap fixing end 12 is provided with a fixed end traction hole 1202 arranged corresponding to the position of the head end guide head 1101 and a snap traction line through-hole 1206 opened on the tube wall of the snap fixing end 12 and connected to the fixed end traction hole 1202; a snap traction line 13 is passed through the head end traction hole 1102, the fixed end traction hole 1202 and the snap traction line through-hole 1206, and the two ends of the snap traction line 13 extend outward from the snap traction line through-hole 1206.

[0058] The forming locking structure of the heart valve repair device is provided with a forming ring body 01, and a buckle structure is connected at both ends of the forming ring body 01. The forming ring body 01 is annular, and the buckle structure includes a buckle fixing end 12 and a buckle head end 11 connected to the opposite ends of the forming ring body 01. A head end traction hole 1102 is provided on the buckle head end 11, and a fixed end traction hole 1202 is provided on the buckle fixing end 12. A tube wall of the buckle fixing end 12 is provided with a buckle fixing end traction hole 1202. 02 is connected to the buckle traction line through-hole 1206, and the buckle traction line 13 is passed between the fixed end traction hole 1202 and the buckle traction line through-hole 1206, so that the two ends of the buckle traction line 13 extend outward from the buckle traction line through-hole 1206, and the buckle head end 11 and the buckle fixed end 12 are driven to engage by pulling the buckle traction line 13, thereby realizing the tail locking of the forming ring body 01, which can avoid the shrinkage of the forming ring body 01 when locking and reduce operational errors.

[0059] 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.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] In a replaceable embodiment, the head end metal tube 4 is provided with a head end barb 20, and the snap head end 11 and the head end metal strip 2 are provided with a head end barb groove 21 that cooperates with the head end barb 20; the fixed end metal tube 5 is provided with a fixed end barb 22, and the snap fixed end 12 and the fixed end metal strip 3 are provided with a fixed end barb groove 23 that cooperates with the fixed end barb 22.

[0067] In a replaceable embodiment, the head end metal tube 4 is provided with a head end barb groove 21, and the snap head end 11 and the head end metal strip 2 are provided with head end barbs 20 that cooperate with the head end barb groove 21; the fixed end metal tube 5 is provided with a fixed end barb groove 23, and the snap fixed end 12 and the fixed end metal strip 3 are provided with fixed end barbs 22 that cooperate with the fixed end barb groove 23.

[0068] 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.

[0069] In an alternative embodiment, as Figure 21-22 As shown, 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 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 provided with a fixed end spring lock tongue that cooperates with the fixed end spring lock cavity.

[0070] 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.

[0071] 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.

[0072] 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 1206 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 1206, and the two ends of the clip traction line 13 extend outward from the clip traction line through-hole 1206.

[0073] 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.

[0074] In an alternative embodiment, as Figure 10As 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] like Figure 2 As shown, in this embodiment, the coating substrate 02 includes a soft coating substrate 14, a mesh substrate 15 covering the soft coating substrate 14, and a coating film 16 covering 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 16 is made of PET film or PET mesh and is annular. Using silicone to make the soft coating substrate 14 can reduce the production cost of the forming ring body 01 and improve production efficiency.

[0079] 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.

[0080] 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.

[0081] like Figure 2 、 Figure 23 As 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 16 includes an upper coating film and a lower coating film.

[0082] In summary, the shaping and locking structure of the heart valve repair device is provided with a shaping ring body 01, and a buckle structure is connected at both ends of the shaping ring body 01. The shaping ring body 01 is annular, and the buckle structure includes a buckle fixing end 12 and a buckle head end 11 connected to the opposite ends of the shaping ring body 01. A head end traction hole 1102 is provided on the buckle head end 11, a fixed end traction hole 1202 is provided on the buckle fixing end 12, and a tube wall of the buckle fixing end 12 is provided with a buckle fixing hole 1202. The buckle traction line outlet hole 1206 connected to 1202 is provided with a buckle traction line 13 between the fixed end traction hole 1202 and the buckle traction line outlet hole 1206, so that the two ends of the buckle traction line 13 extend outward from the buckle traction line outlet hole 1206. By pulling the buckle traction line 13, the buckle head end 11 and the buckle fixed end 12 are driven to engage, thereby realizing the tail locking of the forming ring body 01, which can avoid the shrinkage of the forming ring body 01 when locking and reduce operational errors.

[0083] 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 form-locking structure of a heart valve repair device, characterized in that: The invention comprises a forming ring body (01) and a buckle structure connected to the head and tail ends of the forming ring body (01) so that the forming ring body (01) is annular; the buckle structure comprises a buckle fixed end (12) and a buckle head end (11) connected to the opposite ends of the forming ring body (01); 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) arranged corresponding to the position of the head end guide head (1101) and a buckle traction line through hole (1206) opened on the tube wall of the buckle fixed end (12) and connected to the fixed end traction hole (1202); the head A buckle traction line (13) is passed through the end traction hole (1102), the fixed end traction hole (1202) and the buckle traction line passing hole (1206), and the two ends of the buckle traction line (13) extend outward from the buckle traction line passing hole (1206); an accommodating cavity (1201) capable of accommodating the head end guide head (1101) is provided inside the buckle fixed end (12), and the fixed end traction hole (1202) is communicated with the accommodating cavity (1201); an inner concave notch (1203) is provided on the inner wall of the buckle fixed end (12) corresponding to the accommodating cavity (1201), and a head end barb (1103) engaged with the concave notch (1203) is provided on the outer periphery of the head end guide head (1101).

2. The form-locking structure of the heart valve repair device according to claim 1, characterized in that: The head end barb (1103) is in the shape of a petal, a rectangle, a pyramid or a fan leaf.

3. The form-locking structure of the heart valve repair device according to claim 2, characterized in that: At least two head end barbs (1103) are provided on the outer periphery of the head end guide head (1101).

4. The formed locking structure of the heart valve repair device according to claim 1, characterized in that: The buckle fixing end (12) is a split structure.

5. The form-locking structure of the heart valve repair device according to claim 1, 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).

6. The form-locking structure of the heart valve repair device according to claim 5, 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).

7. The form-locking structure of the heart valve repair device according to any one of claims 1 to 6, characterized in that: The forming ring body (01) comprises a head end metal strip (2), a fixed end metal strip (3), a head end metal tube (4) sleeved on one end of the head end metal strip (2) close to the buckle structure, a fixed end metal tube (5) sleeved on one end of the fixed end metal strip (3) close to the buckle structure, and a connecting portion metal tube (6) sleeved between the head end metal strip (2) and the fixed end metal strip (3); one end of the head end metal strip (2) and the fixed end metal strip (3) away from the fixed end metal tube (5) and the head end metal tube (4) are both inserted into the inner cavity of the connecting portion metal tube (6); the head end metal strip (2) and the connecting portion metal tube (6), as well as the fixed end metal strip (3) and the connecting portion metal tube (6), are all connected by a ring shrinkage locking structure.

8. The form-locking structure of the heart valve repair device according to claim 7, characterized in that: A buckle assembly (10) is connected between the fixed end metal tube (5) and the head end metal tube (4); a first traction hole (27) is provided on 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 portion metal tube (6); and two contraction traction lines (8) are also included, wherein one contraction traction line (8) passes through the first traction hole (27) on the head end metal strip (2) and one of the second traction holes (28) on the connecting portion metal tube (6) close to the fixed end metal strip (3); and the other contraction traction line (8) passes through the first traction hole (27) on the fixed end metal strip (3) and another of the second traction holes (28) on the connecting portion metal tube (6) close to the head end metal strip (2).

9. The form-locking structure of the heart valve repair device according to claim 8, characterized in that: The head end metal strip (2) and the fixed end metal strip (3) are both arc-shaped and have rectangular cross sections; the head end metal tube (4), the fixed end metal tube (5) and the connecting portion metal tube (6) also have rectangular cross sections.

10. The form-locking structure of the heart valve repair device according to claim 8, characterized in that: A plurality of avoidance notches are provided on the inner side of the joint metal tube (6).

11. The form-locking structure of the heart valve repair device according to claim 7, characterized in that: The two sides 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); the two sides 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).

Images