A bioartificial heart valve device

Abstract

The present invention discloses an artificial bioprosthetic heart valve device, which relates to the technical field of cardiac surgery. The leaflets are fixedly mounted on a support assembly so that the leaflets are supported and limited. The first edge (support wall 42) of the suture ring is used for suturing and fixing with the support assembly, and the second edge (suture wall 41) is used for suturing with the tissue ring. The wall surface of the suture ring has an axial extension so that there is an axial spacing between the first edge (support wall 42) and the second edge (suture wall 41). The first edge (support wall 42) is located outside the ventricle. The wall surface of the suture ring provides axial support for the support assembly. The axial extension size of the wall surface of the suture ring is used to move the support assembly away from the ventricle, thereby reducing the size of the support assembly extending into the ventricle. This structure does not require additional thickness increase of the suture ring, and will not affect the axial position of the support assembly when the suture is tightened.

Description

Technical Field

[0001] The present invention relates to the technical field of cardiac surgery, and further to an artificial bioheart valve device. Background Art

[0002] A prosthetic heart valve is an implantable medical device used to treat heart valve disease or defects, replacing damaged heart valves and restoring their normal function. Depending on the material used, prosthetic heart valves are primarily categorized as mechanical and bioprosthetic. Depending on the implant location, prosthetic heart valves can be divided into the aortic valve and the mitral valve.

[0003] An artificial biological valve consists of structures such as leaflets, a valve frame, a valve seat, and a valve ring (suture ring). The leaflets are the main active part of the valve, responsible for opening and closing, and unidirectionally controlling the direction of blood flow. The biological valve can be made of pig or cow pericardium; the valve frame is the structure that supports the leaflets, which can be made of metal or synthetic materials. The leaflets and the valve frame are relatively fixed; the valve ring is a ring-shaped structure, which is used to be relatively fixed to the human tissue ring and sutured to the valve seat. The valve seat and the valve frame are relatively sutured to each other.

[0004] To maintain the shape and position of the valve, the valve frame has three downward-extending pointed structures. When the artificial mitral valve is in place, the three pointed structures will extend downward into the ventricle. Since the valve frame is usually made of hard materials such as metal, the pointed structures can easily cause damage to the ventricular wall when they come into contact with it. Therefore, it is necessary to reduce the size of the valve frame extending into the ventricle to avoid close contact between the three pointed structures and the inner wall of the ventricle. However, the size of the three pointed structures of the valve frame is adapted to the structure and size of the leaflets, and the structure and size of the leaflets cannot be changed due to mechanical limitations.

[0005] For those skilled in the art, how to reduce the size of the hard structure extending into the ventricle, thereby reducing the risk of the artificial valve structure damaging the ventricular wall, is a technical problem that needs to be solved at present. Summary of the Invention

[0006] The present invention provides a bioprosthetic heart valve device, which is extended in the axial direction by a sewing ring. The wall structure of the sewing ring is used to provide support in the axial direction, so that the support assembly is moved away from the ventricle in the direction of the atrium, thereby reducing the size of the valve extending into the ventricle. The specific scheme is as follows:

[0007] A bioprosthetic heart valve device comprises a valve leaflet, a support assembly, and a sewing ring; the valve leaflet is fixed to the support assembly; a first edge of the sewing ring is used for suturing and fixing with the support assembly, and a second edge of the sewing ring is used for suturing with a tissue ring;

[0008] The wall of the sewing ring extends axially so that there is an axial distance between the first edge and the second edge; the first edge is located outside the ventricle, and the wall of the sewing ring provides support for the support assembly, reducing the size of the support assembly extending into the ventricle.

[0009] Optionally, the support assembly includes a valve frame and a valve seat, the first edge of the sewing ring is used to be sutured and fixed to the valve seat, and the valve frame is used to be sutured and fixed to the leaflet; the valve frame and the valve seat can be sutured and fixed.

[0010] Optionally, the sewing ring includes a sewing wall and a supporting wall, the sewing wall is folded and fixed to the outer surface of the supporting wall; the first edge is located on the supporting wall, and the second edge is located on the sewing wall;

[0011] The suture wall is used to contact the tissue ring and has an overlapping area with the tissue ring; the support wall is cylindrical parallel to the axial direction or has a cross-section that gradually decreases in a direction away from the ventricle.

[0012] Optionally, the valve frame is provided with a first connecting through hole perpendicular to the axial direction, and a positioning suture hole is provided along the fixed edge of the leaflet.

[0013] Optionally, the flap frame is made of a continuous sheet connected end to end.

[0014] Optionally, the petal seat is provided with a second connecting through hole perpendicular to the axial direction.

[0015] Optionally, the valve seat includes a relatively fixed first wall and a second wall, the first wall protrudes from the inner surface of the second wall, the first wall and the second wall are perpendicularly fixed to each other to form an "L"-shaped cross section; the second wall protrudes toward the direction of the ventricle;

[0016] The second connecting hole is arranged on the second wall surface, and the outer surface of the second wall surface contacts the inner surface of the sewing ring; the first wall surface contacts and supports the leaflets and the leaflet frame in the axial direction, and the second wall surface is located on the periphery of the leaflets and the leaflet frame.

[0017] Optionally, the sewing ring includes a middle felt cloth layer and polyester woven cloth layers arranged on both sides of the middle felt cloth layer.

[0018] Optionally, reinforcing ribs are provided in the sewing ring to increase strength.

[0019] The present invention provides an artificial bio-heart valve device, in which the leaflets are fixedly mounted on a support assembly so that the leaflets are supported and limited; the first edge of the sewing ring is used for suturing and fixing with the support assembly, and the second edge is used for suturing with the tissue ring; the wall of the sewing ring has an axial extension so that there is an axial spacing between the first edge and the second edge, the first edge is located outside the ventricle in the left atrium, the wall of the sewing ring is axially combined with the support assembly to provide support for the second edge, and the axial extension size of the wall of the sewing ring is utilized to move the support assembly away from the ventricle, thereby reducing the size of the support assembly extending into the ventricle. With this structure, there is no need to increase the thickness of the sewing ring, and the axial position of the support assembly will not be affected when the suture is tightened. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only 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.

[0021] Figure 1 A schematic diagram of the cooperation between the bioprosthetic heart valve device provided by the present invention and the atrioventricular valve;

[0022] Figure 2 A schematic structural diagram of a bioprosthetic heart valve device provided by the present invention;

[0023] Figure 3 A front view of the bioprosthetic heart valve device provided by the present invention;

[0024] Figure 4 A bottom view of the bioprosthetic heart valve device provided by the present invention;

[0025] Figure 5 A schematic cross-sectional view of the bioprosthetic heart valve device provided by the present invention cooperating with the atrioventricular valve;

[0026] Figure 6 is a partial cross-sectional schematic diagram of a suture ring;

[0027] Figure 7 Schematic diagram of the leaflet and its positioning suture holes.

[0028] The diagram includes:

[0029] Leaflet 1, positioning suture hole 11, leaflet frame 2, first connecting through hole 21, leaflet seat 3, second connecting through hole 31, first wall 301, second wall 302, suture ring 4, suture wall 41, support wall 42, middle felt layer 401, polyester woven layer 402, tissue ring A. DETAILED DESCRIPTION

[0030] The core of the present invention is to provide an artificial bioprosthetic heart valve device, which is extended in the axial direction by a sewing ring, and the wall structure of the sewing ring is used to provide support in the axial direction, so that the support assembly is moved outward away from the ventricle, reducing the size of the device extending into the ventricle.

[0031] In order to enable those skilled in the art to better understand the technical solution of the present invention, the bioprosthetic heart valve device of the present invention will be described in detail below with reference to the accompanying drawings and specific implementation methods.

[0032] The present invention provides an artificial bio-heart valve device, which can be applied to the atrioventricular valve, combined with Figure 1 、 Figure 2 As shown, the valve includes leaflets 1, a support assembly, and a sewing ring 4. The leaflets 1 are fixed to the support assembly, a rigid structure typically made of alloy or synthetic materials, which controls the position of the leaflets 1. The leaflets 1 are typically three in number and made from porcine or bovine pericardium. The leaflets 1 fit together, replacing the human heart valve and ensuring unidirectional blood flow.

[0033] A portion of the suture ring 4 near the first edge (located at the subsequent support wall 42) is used for suturing and fixing with the support assembly, and a portion of the suture ring 4 near the second edge (located at the subsequent suturing wall 41) is used for suturing with the tissue ring A. Figure 1 、 Figure 2 As shown, the upper edge of the sewing ring 4 is the first edge, and the lower edge is the second edge. Near the first edge of the sewing ring 4, there is an area that overlaps with the support assembly, and near the second edge of the sewing ring 4, there is an area that overlaps with the tissue ring A. Suture fixation is achieved by suturing the overlapping area with sutures.

[0034] The sewing ring 4 is made of a flexible or elastic material and has a certain support strength. The second edge is adapted to the shape of the tissue ring A. The wall of the sewing ring 4 has an axial extension so that there is an axial distance between the first edge and the second edge. The axial direction referred to here is based on the direction of blood flow, with the blood flow direction being the axial direction and the direction perpendicular to the blood flow being the radial direction. The axial extension of the wall of the sewing ring 4 allows the first edge to be located outside the ventricle ( Figure 1 、 Figure 5 The lower part of the center is the ventricle), and the wall of the sewing ring 4 provides support for the support assembly, so that the support assembly is away from the ventricle and the size of the support assembly extending into the ventricle is reduced.

[0035] The wall of the sewing ring 4 extends in the axial direction. The axially extended portion of the sewing ring 4 is an annular cylindrical structure, which can be a circular cylinder, a conical cylinder, or other irregular cylindrical structures. The present invention utilizes the axially extended portion of the wall of the sewing ring 4 to provide axial support. The sewing ring 4 is a three-dimensional structure, and there is no need to increase the thickness to push the support assembly out of the ventricle. As long as the axial extension length of the sewing ring 4 reaches a sufficient size, when the sewing ring 4 is fixedly sutured to the tissue ring A, the wall thickness can be prevented from being squeezed by the suture thread, resulting in a reduction in the ejection size. This allows the support assembly to maintain a larger ejection size in the direction of the atrium, fundamentally reducing the size of the support assembly extending into the ventricle, and forming a stable support.

[0036] Based on the above solution, the support assembly of the present invention includes a valve frame 2 and a valve seat 3. The valve frame 2 and valve seat 3 are two independently arranged structures, made of alloy or synthetic materials, to provide sufficient support strength. A portion of the sewing ring 4 near the first edge is used for suturing and securing to the valve seat 3. The valve frame 2 is used for suturing and securing to the leaflets 1, and the valve frame 2 and valve seat 3 are suturing and securing each other, so that the leaflets 1, valve frame 2, valve seat 3, and sewing ring 4 are relatively fixed to form an integrated structure.

[0037] It should be noted that the suturing between the leaflets 1 and the valve frame 2, the suturing between the valve seat 3 and the sewing ring 4, and the suturing between the valve frame 2 and the valve seat 3 are all pre-assembled and completed at the factory, representing the suturing assembly production process. The suturing between the sewing ring 4 and the tissue ring A is completed during surgery, representing the implantation suturing process.

[0038] like Figure 1 、 Figure 2 As shown, the sewing ring 4 provided by the present invention includes a sewing wall 41 and a support wall 42, wherein the first edge is located on the support wall 42, and the second edge is located on the sewing wall 41; wherein the sewing wall 41 is folded and fixed to the outer surface of the support wall 42, and a bend is formed between the sewing wall 41 and the support wall 42, and the angle of the bend is generally greater than 90 degrees. Figure 5 As shown, the suture wall 41 is used to contact the tissue ring A and has an overlapping area with the tissue ring A. During surgical implantation, the suture passes through the overlapping area to suture and fix the suture ring 4 and the tissue ring A.

[0039] The support wall 42 is cylindrical and parallel to the axial direction. The cross section of the support wall 42 is kept equal at all positions along the axial direction. The support wall 42 mainly provides axial bearing force, which can provide stable support.

[0040] Combine Figure 2 As shown, the petal frame 2 is provided with a first connecting through hole 21 perpendicular to the axial direction, the first connecting through hole 21 is provided through in the radial direction, and a plurality of first connecting through holes 21 are provided at intervals on the petal frame 2. Figure 7 As shown, positioning suture holes 11 are provided along the fixed edge of the leaflet 1. Several positioning suture holes 11 are provided at intervals on the leaflet 1. Each positioning suture hole 11 can be aligned with a first connecting through hole 21. The first connecting through hole 21 and the positioning suture hole 11 are directly opposite each other for suturing. When the flap frame 2 and the leaflet 1 are sutured relative to each other, the suture can pass through the first connecting through hole 21 and the positioning suture hole 11 to prevent the leaflet and the flap frame from being offset and ensure the stability of the suture fixation. Positioning suture holes 11 are provided along the fixed edge of the leaflet so as to correspond to the first connecting through holes 21 on the corresponding flap frame 2. The leaflet 1 and the flap frame 2 are sewn together, thereby avoiding the difficulty of accurately aligning the leaflet 1 with the flap frame 2 during the suture assembly process, improving the workability, and also improving the stability and firmness of the suture between the leaflet 1 and the flap frame 2.

[0041] The flap frame 2 is made of a continuous thin sheet connected end to end and is processed and formed in one piece. There are bent areas in the flap frame 2, and the bent areas have different curvatures. Some areas have large curvatures, while other areas have small curvatures, which are used to adapt to the edge shape of the leaflet 1. Figure 1 The lowest pointed structure of the valve frame 2 is located closest to the ventricle.

[0042] Combine Figure 2 As shown, the petal seat 3 is provided with a second connecting through hole 31 perpendicular to the axial direction, and the second connecting through hole 31 is provided along the radial direction. Several second connecting through holes 31 are provided at intervals on the petal seat 3. When the petal seat 3 and the suture ring 4 are sutured relative to each other, the suture can pass through the second connecting through hole 31 to prevent the suture from being offset and ensure the stability of the suture fixation.

[0043] Combine Figure 5 As shown, in the area where the petal frame 2 and the petal seat 3 overlap radially, the second connecting through hole 31 and the first connecting through hole 21 are arranged corresponding to each other. When the petal frame 2 and the petal seat 3 are suturing, the suture passes through the second connecting through hole 31 and the first connecting through hole 21 to achieve suturing and fixation, thereby avoiding misalignment of the petal frame 2 and the petal seat 3.

[0044] like Figure 5 As shown, the valve seat 3 includes a relatively fixed first wall 301 and a second wall 302. The first wall 301 extends radially, the second wall 302 extends axially, and the second wall 302 protrudes toward the ventricle. The first wall 301 is protruding from the inner surface of the second wall 302. The first wall 301 and the second wall 302 are fixed perpendicularly to each other to form an "L"-shaped cross section. The second connecting hole 31 is provided on the second wall 302, combined with Figure 5 As shown, the outer surface of the second wall 302 contacts the inner surface of the sewing ring 4, and there is an overlapping area between the two. The first wall 301 supports the valve frame 2 in the axial direction. Figure 5There is a section on the fixed edge of the leaflet 1 that fits the outer surface of the leaflet frame 2, and converges towards the center after bending. When installed in place, the leaflet frame 2 and the leaflet seat 3 clamp the leaflet 1 together, and the lower surface of the first wall 301 contacts the upper surface of the leaflet 1, and the upper surface of the leaflet frame 2 contacts the lower surface of the leaflet 1; the second wall 302 is located on the periphery of the leaflet 1 and the leaflet frame 2, and the second wall 302 surrounds the leaflet 1 and the leaflet frame 2 in the middle.

[0045] Combine Figure 6 As shown, the sewing ring 4 provided by the present invention includes a middle felt layer 401 and polyester woven fabric layers 402 disposed on both sides of the middle felt layer 401. The multi-layer composite structure provides the sewing ring 4 with flexibility and good support performance. In addition to using this composite layer structure, the sewing ring 4 can also be made of other materials, and these specific implementations are intended to be included within the scope of protection of the present invention.

[0046] To provide increased support, reinforcing ribs can be provided within the sewing ring 4. Several ribs are spaced apart within the ring and arranged symmetrically about the central axis of the ring. These ribs help enhance the axial support capability of the ring. The ribs can extend from a first edge (support wall 42) to a second edge (suturing wall 41) of the ring 4. In this case, the ribs' axial projection length equals the axial projection length of the ring 4. Alternatively, the ribs' axial projection length can be less than the axial projection length of the ring 4.

[0047] The above description of the disclosed embodiments is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A bioprosthetic heart valve device, characterized in that: The invention comprises a leaflet (1), a support assembly, and a suturing ring (4); the leaflet (1) is fixed to the support assembly; a portion of the suturing ring (4) near the first edge is used for suturing and fixing with the support assembly, and a portion of the suturing ring (4) near the second edge is used for suturing with the tissue ring; The wall of the sewing ring (4) has an axial extension so that there is an axial distance between the first edge and the second edge; the first edge is located outside the ventricle, and the wall of the sewing ring (4) provides support for the support assembly, thereby reducing the size of the support assembly extending into the ventricle; The support assembly comprises a valve frame (2) and a valve seat (3); a portion of the suture ring (4) close to the first edge is used for suturing and fixing with the valve seat (3); the valve frame (2) is used for suturing and fixing with the leaflet (1); the valve frame (2) and the valve seat (3) can be sutured and fixed; The flap frame (2) is provided with a first connecting through hole (21) perpendicular to the axial direction, and a positioning suture hole (11) is provided along the fixed edge of the flap (1); the first connecting through hole (21) and the positioning suture hole (11) are aligned with each other for suturing; The petal seat (3) is provided with a second connecting through hole (31) perpendicular to the axial direction; when the petal seat (3) and the suture ring (4) are sutured relative to each other, the suture thread passes through the second connecting through hole (31); The valve seat (3) comprises a relatively fixed first wall surface (301) and a second wall surface (302), wherein the first wall surface (301) protrudes from the inner surface of the second wall surface (302), and the first wall surface (301) and the second wall surface (302) are fixed perpendicularly to each other to form an "L"-shaped cross section; the second wall surface (302) protrudes toward the ventricle; The second connecting through hole (31) is provided on the second wall surface (302), and the outer surface of the second wall surface (302) contacts the inner surface of the sewing ring (4); the first wall surface (301) supports the valve frame (2) in the axial direction, and the second wall surface (302) is located at the periphery of the leaflet (1) and the valve frame (2); The second connecting through hole (31) and the first connecting through hole (21) are arranged corresponding to each other, and when the flap frame (2) and the flap seat (3) are sutured, the suture passes through the second connecting through hole (31) and the first connecting through hole (21) to achieve suture fixation.

2. The bioprosthetic heart valve device according to claim 1, wherein: The sewing ring (4) comprises a sewing wall (41) and a supporting wall (42), wherein the sewing wall (41) is folded and fixed to the outer surface of the supporting wall (42); the first edge is located on the supporting wall (42), and the second edge is located on the sewing wall (41); The suture wall (41) is used to contact the tissue ring and has an overlapping area with the tissue ring; the support wall (42) is cylindrical parallel to the axial direction or has a cross-section that gradually decreases in a direction away from the ventricle.

3. The bioprosthetic heart valve device according to claim 1, wherein: The petal frame (2) is made of continuous thin sheets connected end to end.

4. The bioprosthetic heart valve device according to claim 1, wherein: The sewing ring (4) comprises a middle felt cloth layer (401) and polyester woven cloth layers (402) arranged on both sides of the middle felt cloth layer (401).

5. The bioprosthetic heart valve device according to claim 1, wherein: Reinforcement ribs are provided in the sewing ring (4) for increasing strength.

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