Artificial biological heart valve device

Abstract

The invention discloses an artificial biological heart valve device, and relates to the technical field of heart surgeries. Valve leaflets are fixedly mounted on a supporting assembly, so that the valve leaflets are supported and limited; the first edge (supporting wall 42) of the suture ring is used for suturing and fixing with the supporting assembly, and the second edge (suturing wall 41) is used for suturing with the tissue ring; the wall face of the suture ring has extension in the axial direction, so that an axial distance exists between the first edge (supporting wall 42) and the second edge (suture wall 41), the first edge (supporting wall 42) is located outside the ventricle, the wall face of the suture ring supports the supporting assembly in the axial direction, and the supporting assembly is made to be away from the ventricle by means of the extension size of the wall face of the suture ring in the axial direction. By the adoption of the structure, the thickness of the suture ring does not need to be additionally increased, and the axial position of the supporting assembly cannot be affected during suture and tensioning.

Description

Technical Field

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

[0002] An artificial heart valve is a cardiac implantable medical device used to treat heart valve disease or defects. It is used to replace heart valves damaged by disease and restore their normal function. Depending on the material, artificial heart valves are mainly divided into two types: mechanical valves and biological valves. Depending on the implantation location, artificial heart valves can be divided into aortic valves and mitral valves.

[0003] The 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 are relatively fixed to the valve frame; the valve ring is a ring-shaped structure, which is used to be relatively fixed to the human tissue ring and to be sutured and fixed to the valve seat. The valve seat and the valve frame are relatively sutured and fixed.

[0004] In order to maintain the shape and position of the valve, the valve frame has three pointed structures extending downward. 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 are likely to cause damage to the ventricle wall when they contact the ventricle wall. 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 properties.

[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 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 away from the ventricle in the direction of the atrium, and the size of the valve extending into the ventricle is reduced. The specific scheme is as follows:

[0007] A bioartificial heart valve device comprises a valve leaflet, a support assembly, and a sewing ring; the valve leaflet is fixed to the support assembly; the first edge of the sewing ring is used for suturing and fixing with the support assembly, and the 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, thereby 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 suture ring is used for suturing and fixing with the valve seat, and the valve frame is used for suturing and fixing with the valve leaflet; the valve frame and the valve seat can be sutured and fixed.

[0010] Optionally, the suture ring comprises a suture wall and a support wall, the suture wall is folded and fixed to the outer surface of the support wall; the first edge is located at the support wall, and the second edge is located at the suture wall;

[0011] The suture wall is used to contact the tissue ring and have an overlapping area with the tissue ring; the support wall is in a cylindrical shape 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 valve 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 comprises a first wall surface and a second wall surface that are relatively fixed, the first wall surface protrudes from the inner surface of the second wall surface, the first wall surface and the second wall surface are perpendicularly fixed to each other to form an "L"-shaped cross section; the second wall surface protrudes toward the direction of the ventricle;

[0016] The second connecting through 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 valve frame in the axial direction, and the second wall surface is located at the periphery of the leaflets and the valve 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 biological heart valve device, wherein the leaflets are fixedly mounted on a support assembly so that the leaflets are supported and limited; the first edge of a suture ring is used for suture and fixation with the support assembly, and the second edge is used for suture with a tissue ring; the wall surface of the suture ring has an axial extension amount 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 surface of the suture ring is axially combined with the support assembly to provide support for the second edge, and the axial extension size of the wall surface of the suture ring is utilized to keep the support assembly away from the ventricle, thereby reducing the size of the support assembly extending into the ventricle, and the use of this structure does not require an additional increase in the thickness of the suture ring, and will not affect the axial position of the support assembly 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 drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. 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 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 diagram of the structure 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 cross-sectional schematic diagram of the cooperation between the bioprosthetic heart valve device provided by the present invention and the atrioventricular valve;

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

[0027] Figure 7 Schematic diagram of the leaflets and their positioning suture holes.

[0028] The figure includes:

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

[0030] The core of the present invention is to provide an artificial biological 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 and the size extending into the ventricle is reduced.

[0031] In order to enable those skilled in the art to better understand the technical solution of the present invention, the artificial bioprosthetic heart valve device of the present invention will be described in detail below in conjunction with 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, it includes structures such as leaflets 1, support components, and sewing rings 4. The leaflets 1 are fixed to the support components, which are hard structures, usually made of alloy materials or synthetic materials, and the position of the leaflets 1 is limited by the support components. The leaflets 1 are usually provided with three pieces, made of pig or cow pericardium; the leaflets 1 match each other, replacing the human heart valve, and can achieve unidirectional blood conduction.

[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 suture wall 41) is used for suturing with the tissue ring A. Figure 1 , Figure 2 As shown, the upper edge line of the sewing ring 4 is the first edge, and the lower edge line is the second edge. There is a section of area overlapping with the support assembly near the first edge of the sewing ring 4, and there is a section of area overlapping with the tissue ring A near the second edge of the sewing ring 4, and the overlapping area is sutured and fixed by 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 spacing between the first edge and the second edge. The axial direction referred to here is based on the blood flow direction. The blood flow direction is the axial direction, and the direction perpendicular to the blood flow direction is the radial direction. The wall of the sewing ring 4 has an axial extension, which can make the first edge outside the ventricle ( Figure 1 , Figure 5 The lower part of the center is the ventricle), and the wall of the suture 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 has an axial extension, and the axially extended part 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 uses the axially extended part 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 component 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, it can avoid the situation where the wall thickness is squeezed by the suture to reduce the ejection size, so that the support component maintains a larger ejection size in the direction of the atrium, fundamentally reducing the size of the support component extending into the ventricle, and forming a stable support.

[0036] On the basis of the above scheme, the support assembly of the present invention includes a valve frame 2 and a valve seat 3. The valve frame 2 and the valve seat 3 are two structures independently arranged from each other. The valve frame 2 and the valve seat 3 are made of alloy material or synthetic material, which can provide sufficient support strength. A part of the area of ​​the sewing 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 valve leaf 1, and the valve frame 2 and the valve seat 3 are suturing and fixing, so that the valve leaf 1, the valve frame 2, the valve seat 3 and the sewing ring 4 are relatively fixed to form an integral 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 assembled in the factory, which is the suturing assembly production process. The suturing between the sewing ring 4 and the tissue ring A is completed during the operation, which is 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 supporting wall 42, the first edge is located on the supporting 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 supporting wall 42, and a bend is formed between the sewing wall 41 and the supporting 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 in a cylindrical shape parallel to the axial direction, and the cross section of the support wall 42 is kept equal at each position along the axial direction. The support wall 42 mainly provides axial bearing force, and can obtain stable support.

[0040] Combination 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, a positioning suture hole 11 is 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 to each other for suturing. When the valve 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 valve frame from being offset and ensure the stability of suture fixation. Positioning suture holes 11 are provided along the fixed edge of the leaflet so as to correspond to the first connecting through hole 21 on the corresponding valve frame 2. The leaflet 1 and the valve frame 2 are sewn together, which avoids the difficulty of accurately aligning the leaflet 1 with the valve frame 2 during the suture assembly process, improves the processability, and also improves the stability and firmness of the suture between the leaflet 1 and the valve frame 2.

[0041] The valve frame 2 is made of a continuous thin sheet connected end to end and is formed in one piece. The valve frame 2 has bent areas, and the bent areas have different curvatures, some areas have large curvatures, and 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] Combination 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 radially through-set. A plurality of second connecting through holes 31 are spaced apart 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 deviated, thereby ensuring the stability of the suture fixation.

[0043] Combination Figure 5 As shown, in the area where the valve frame 2 and the valve 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 valve frame 2 and the valve 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 valve frame 2 and the valve seat 3.

[0044] like Figure 5 As shown, the valve seat 3 includes a first wall 301 and a second wall 302 that are relatively fixed. 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 protrudingly arranged on 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 through hole 31 is arranged on the second wall 302, and the second connecting through hole 31 is arranged on the second wall 302. 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 valve frame 2, which converges toward the center after bending. When installed in place, the valve frame 2 and the valve seat 3 clamp the leaflet 1 against each other. The lower surface of the first wall 301 contacts the upper surface of the leaflet 1, and the upper surface of the valve frame 2 contacts the lower surface of the leaflet 1; the second wall 302 is located at the periphery of the leaflet 1 and the valve frame 2, and the second wall 302 surrounds the leaflet 1 and the valve frame 2 in the middle.

[0045] Combination Figure 6 As shown, the sewing ring 4 provided by the present invention includes a middle felt cloth layer 401 and polyester woven cloth layers 402 arranged on both sides of the middle felt cloth layer 401, and adopts a multi-layer composite structure, so that the sewing ring 4 has flexibility and good supporting performance. In addition to adopting this composite layer structure, the sewing ring 4 can also be made of other materials, and these specific implementation forms should be included in the protection scope of the present invention.

[0046] In order to provide support strength, reinforcing ribs for increasing strength may be provided in the sewing ring 4, and a plurality of reinforcing ribs are distributed at intervals in the sewing ring 4, and the reinforcing ribs are distributed centrally and symmetrically about the central axis of the sewing ring 4, and the reinforcing ribs help to improve the axial support capacity of the sewing ring 4. The reinforcing ribs may extend from the first edge of the sewing ring 4 (support wall 42) to the second edge (sewing wall 41), and at this time, the projected length of the reinforcing ribs in the axial direction is equal to the projected length of the sewing ring 4 in the axial direction; the projected length of the reinforcing ribs in the axial direction may also be less than the projected length of the sewing ring 4 in the axial direction.

[0047] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one 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 will not be limited to the embodiments shown herein, but rather 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 valve leaflet (1), a support component, and a sewing ring (4); the valve leaflet (1) is fixed to the support component; a portion of the sewing ring (4) close to the first edge is used for being sutured and fixed to the support component, and a portion of the sewing ring (4) close to the second edge is used for being sutured to the tissue ring; The wall surface 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 surface of the sewing ring (4) provides support for the support component, thereby reducing the size of the support component extending into the ventricle.

2. The bioprosthetic heart valve device according to claim 1, characterized in that: 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 suture fixation with the valve seat (3); the valve frame (2) is used for suture fixation with the valve leaflet (1); the valve frame (2) and the valve seat (3) can be sutured and fixed.

3. The bioprosthetic heart valve device according to claim 2, characterized in that: The sewing ring (4) comprises a sewing wall (41) and a supporting wall (42); 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 in a cylindrical shape parallel to the axial direction or has a cross-section that gradually decreases in a direction away from the ventricle.

4. The bioprosthetic heart valve device according to claim 2, characterized in that: The valve 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 valve leaf (1).

5. The bioprosthetic heart valve device according to claim 4, characterized in that: The flap frame (2) is made of a continuous thin sheet connected end to end.

6. The bioprosthetic heart valve device according to claim 2, characterized in that: The petal seat (3) is provided with a second connecting through hole (31) perpendicular to the axial direction.

7. The bioprosthetic heart valve device according to claim 6, characterized in that: The valve seat (3) comprises a first wall surface (301) and a second wall surface (302) which are relatively fixed, the first wall surface (301) protruding from the inner surface of the second wall surface (302), the first wall surface (301) and the second wall surface (302) being fixed perpendicularly to each other to form an "L"-shaped cross section; the second wall surface (302) protrudes in the direction of the ventricle; The second connecting through hole (31) is arranged 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).

8. The bioprosthetic heart valve device according to claim 1, characterized in that: 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).

9. The bioprosthetic heart valve device according to claim 1, characterized in that: The sewing ring (4) is provided with reinforcing ribs for increasing strength.

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