CN117442390A

CN117442390A - Artificial heart valve leaflet, valve sinus tube and artificial heart valve sinus tube

Info

Publication number: CN117442390A
Application number: CN202311637509.2A
Authority: CN
Inventors: 张程
Original assignee: Shenzhen Huachang Medical Innovation Co ltd
Current assignee: Shenzhen Huachang Medical Innovation Co ltd
Priority date: 2023-11-30
Filing date: 2023-11-30
Publication date: 2024-01-26

Abstract

The invention provides an artificial heart valve leaflet, a valve sinus tube body and an artificial heart valve sinus tube, wherein the artificial heart valve leaflet comprises an attachment edge, two free edges, a ventricular surface and an aortic surface, the attachment edge is connected between the two free edges, the two free edges are connected, the ventricular surface and the aortic surface are arranged in a back way and are both connected with the attachment edge and the two free edges, the attachment edge is arc-shaped, the ventricular surface is a concave surface, the aortic surface is a convex surface formed after the ventricular surface is concavely arranged, the artificial heart valve leaflet comprises a valve leaflet bottom and a butt joint part, a first side and a second side of the valve leaflet bottom are connected with the butt joint part, the valve leaflet bottom is convexly arranged from the aortic surface to the ventricular surface, and the butt joint part of the first side and the second side is opposite to the attachment edge and is connected with the joint part of the two free edges.

Description

Artificial heart valve leaflet, valve sinus tube and artificial heart valve sinus tube

Technical Field

The invention relates to the technical field related to artificial heart valves, in particular to artificial heart valve leaflets, valves, valve sinuses and an artificial heart valve sinus tube.

Background

For patients with severe heart valves, replacement of prosthetic heart valves is one of the most effective treatments, and currently, prosthetic valves used clinically can be classified into mechanical valves (made of pyrolytic carbon (valve leaflet) and alloy (annulus)) and biological valves (made of biological tissues of pig, cow, etc.) according to the materials. The designed service life of the mechanical valve is longer (more than 50 years), but due to the need of taking anticoagulant drugs for life, adverse events such as bleeding or thromboembolism are easy to occur; the biological valve has short service life, average 5-15 years, easy occurrence of deformation and failure due to calcification. There is therefore a need for a prosthetic heart valve that has a long service life and ensures performance.

Disclosure of Invention

The invention aims to provide an artificial heart valve leaflet and a valve, which are used for solving the problem of thromboembolism caused by blood blockage of the existing artificial heart valve.

The invention also provides a prosthetic heart valve sinus body and a prosthetic heart valve sinus tube.

The artificial heart valve leaflet of the implementation comprises an attaching edge, two free edges, a ventricular surface and an aortic surface, wherein the attaching edge is connected between the two free edges, the two free edges are connected, the ventricular surface and the aortic surface are arranged in a back way, and are connected with the attaching edge and the two free edges,

the attachment edge is arc-shaped, the ventricular surface is concave, the aortic surface is convex formed after the ventricular surface is concave, the artificial heart valve leaflet comprises a valve leaflet bottom and a butt joint part, the butt joint part is connected to the first side and the second side of the valve leaflet bottom, the valve leaflet bottom is convexly arranged from the aortic surface to the ventricular surface direction, and the butt joint part is opposite to the attachment edge and is connected with the joint part of the two free edges.

In one embodiment, the artificial heart valve leaflet includes a valve body, a first coaptation edge and a second coaptation edge, the valve body includes a first side, a second side, and the attachment edge connecting the first side and the second side, and the first side and the second side are linear in outline and are disposed at an included angle; the first and second mating edges are connected to the first and second sides, respectively;

The first pair of edges comprises a first free side edge and a first free edge connected with the first free side edge, the second pair of edges comprises a second free side edge and a second free edge connected with the second free side edge, the first free edge and the second free edge are respectively connected with two opposite sides of the attachment edge, the first free side edge and the second free side edge are far away from the flap body, the first free side edge and the second free side edge are butted at the joint of the first side and the second side,

the butt joint part is connected with the joint of the first free side edge and the second free side edge.

In one embodiment, the first and second engaging edges are triangular flakes, the first free side and the side of the first engaging edge connected to the valve body are long sides, and the second free side and the side of the second engaging edge connected to the valve body are long sides.

In one embodiment, the valve body comprises a first sub-ventricular surface and a first sub-aortic surface, wherein the first sub-ventricular surface and the first sub-aortic surface are arranged back to back, the first sub-ventricular surface is a convex cambered surface, and the first sub-aortic surface is a concave cambered surface;

The attachment edge, the first side, and the second side are all connected to the first sub-ventricular surface and the first sub-aortic surface; the leaflet base is adjacent to a junction of the first side and the second side, the leaflet base being recessed from the first sub-aortic face toward the first sub-ventricular face.

In one embodiment, the prosthetic heart leaflet is symmetrical about a plane of symmetry passing through the valve body, the first side and the second side are symmetrical about the plane of symmetry, the leaflet base is symmetrical about the plane of symmetry, and the first coaptation edge and the second coaptation edge are symmetrical about the plane of symmetry.

The artificial heart valve in the embodiment comprises more than three artificial heart valve leaves and a connecting pipe, wherein the attachment edges of the three artificial heart valve leaves are connected with one end of the connecting pipe, the central lines of the three artificial heart valve She Weirao are arranged, the valve bottoms of the three artificial heart valve leaves surround the central line of the valve, and the butt joint parts of the three artificial heart valve leaves are mutually butt joint around the central line of the valve; the aortic surfaces of the three artificial heart valve leaflets face away from the central line of the connecting pipe; and in the two adjacent artificial heart valve leaflets, the first involution edge of one artificial heart valve leaflet is relatively attached and connected with one side of the second involution edge of the other artificial heart valve leaflet, which is away from the aortic surface.

In one embodiment, the connecting pipe comprises a pipe body and a connecting part, wherein the pipe body is a cylinder with two open ends, the connecting part is formed at the edge of the open end of the pipe body, the connecting part is of an annular structure with three spaced curved surface interfaces, the connecting part surrounds the central line of the connecting pipe, and the curved surface interfaces face away from the pipe body;

the three artificial heart valve leaves are respectively arranged at the curved surface interface positions, the three artificial heart valve She Weirao are arranged at the central line of the connecting pipe, and the attachment edge of each artificial heart valve leaf is connected with the curved surface interface of the connecting part.

The artificial heart valved sinus canal in the embodiment comprises the valve leaflets and the sinus canal, wherein the sinus canal comprises a main tube body;

the main pipe body is a hollow pipe body with two open ends, and comprises three sinus bodies, a first mouth edge and a second mouth edge, wherein three Dou Ti are positioned between the first mouth edge and the second mouth edge and protrude towards the outside of the main pipe body far away from the central line of the sinus pipe, and three Dou Ti are rotationally symmetrical with the central line of the sinus pipe;

the sinus tube further comprises a proximal end and a distal end, the first orifice side is close to the proximal end, the second orifice side is close to the distal end, three valve leaflets are arranged in the main tube body and are rotationally symmetrical about the central line of the sinus tube, the ventricle of each valve leaflet faces towards the proximal end, and the aorta of each valve leaflet faces towards the distal end and is opposite to the inner cavity of the Dou Ti in a spacing manner;

The attachment edge is connected to the Dou Ti, the first free side edge, the first free edge, the second free side edge, and the second free edge being cantilevered relative to a centerline of the Dou Ti; the three leaflets are operative to switch between opening and closing one to the other and deform as the three leaflets open one to the other.

In one embodiment, the sinus tube further comprises a ventricular aortic transition section and a transition section, the ventricular aortic transition section is connected to the first buckling edge, the transition section is connected to the second buckling edge, the proximal end is located at an end of the ventricular aortic transition section facing away from the main tube body, and the distal end is located at an end of the transition section facing away from the main tube body.

In one embodiment, the sinus body includes a leaflet attachment edge and two leaflet She Jiaojie attachment edges, the two leaflet She Jiaojie attachment edges respectively connecting opposite ends of the leaflet attachment edge; the leaflet attachment edges are proximate the proximal end, and both of the leaflet She Jiaojie attachment edges extend from the proximal end toward the distal end; adjacent two of the Dou Tizhong, one of the petals She Jiaojie of one of the sinus bodies has an attachment edge that coincides with one of the petals She Jiaojie of the other sinus body, the leaflet attachment edges being mirror symmetrical about a central plane, and the two petals She Jiaojie attachment edges being mirror symmetrical about a central plane;

The attachment edge of the leaflet is identical in contour and connects with the leaflet attachment edge.

In one embodiment, the leaflet is any one of sewing, ultrasonic welding, bonding, and pressing with the main tubular body.

The sinus tube with valve of the artificial heart in the embodiment comprises the artificial heart valve and the sinus tube, wherein the sinus tube comprises a main tube body and a ventricular aortic transition section,

the ventricular aortic transition section is a tube body and is connected with the first mouth edge, the artificial heart valve is arranged in the sinus tube, the connecting tube is arranged in the ventricular aortic transition section, the outer peripheral surface of the tube body part is in contact with the inner peripheral surface of the ventricular aortic transition section, and the tube body part is connected with the ventricular aortic transition section; three of the leaflets are located in the main tube body rotationally symmetric about a centerline of the sinus tube, with the aorta facing toward the Dou Ti and proximal ends of the sinus tube;

The three leaflets are operative to switch between opening and closing one to the other and deform as the three leaflets open one to the other.

In one embodiment, the connection area of the tube body and the connection portion is a connection edge, the connection edge is connected with the ventricular aortic transition section, and any one of stitching, ultrasonic welding, bonding and pressing is adopted for the connection mode.

The sinus tube body with valve of the artificial heart in the embodiment comprises the artificial heart valve leaves and a sub-sinus tube, wherein the sub-sinus tube comprises a sub-main tube body, a sub-ventricular aortic transition section and a sinus body, the sub-ventricular aortic transition section is connected with one end of the sub-main tube body, the Dou Ti is protruded towards the direction away from the outer side surface of the sub-main tube body,

the sub-sinus tube also comprises a first connecting part and a second connecting part, the sub-main tube body and the sub-ventricular aortic transition section are connected between the first connecting part and the second connecting part and are symmetrically arranged,

the leaflet is positioned inside the sub-body and the attachment edge is connected to the sinus body at a joint edge, the first free side and the second free side are suspended, and an aortic surface of the leaflet is spaced opposite to an endoluminal surface of the Dou Ti.

In one embodiment, the edges of the first and second connection portions connecting the main sub-tubular body and the transition of the main sub-ventricular aorta are stitched edges.

In the embodiment, three sinus canals with valves of the artificial heart are provided; three artificial heart valves Dou Ti are enclosed, three sub-main pipe bodies are enclosed into a main pipe body and are rotationally symmetrical with the central line of the artificial heart valved sinus pipe, and valve leaves are positioned in the main pipe body and are rotationally symmetrical with the central line of the artificial heart valved sinus pipe; two adjacent prosthetic heart valves Dou Tizhong, the sewing edge of the first connecting portion of one of the prosthetic heart valves Dou Ti being opposite to and sewing the sewing edge of the second connecting portion of the other prosthetic heart valve Dou Ti, the first and second connecting portions of each prosthetic heart valve Dou Ti being located outside the main tubular body; the three leaflets are operative to switch between opening and closing one to the other and deform as the three leaflets open one to the other.

In one embodiment, the centerlines of the abutment portions of three of the artificial heart valve leaflets abut each other; the aortic surfaces of the three prosthetic heart valves Dou Ti face away from each other; the first coaptation edge of one prosthetic heart valve Dou Ti is attached and connected to the second coaptation edge of the other prosthetic heart valve Dou Ti opposite the aortic surface of two adjacent prosthetic heart valves Dou Tizhong.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the embodiments of the present invention will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention and that other drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic diagram of the structure of an artificial heart valved sinus tube provided herein;

FIG. 2a is a schematic view of an angle of the valve sinus canal of the artificial heart shown in FIG. 1;

FIG. 2b is a schematic view of the valve sinus tube of the artificial heart shown in FIG. 1 at another angle, wherein only one leaflet is shown;

FIG. 3 is a schematic view of the structure of the leaflets of the prosthetic heart valve shown in FIG. 1;

FIG. 4 is a schematic view of the valve leaflet of FIG. 3 at an angle;

FIG. 5 is a schematic view of another angle of the leaflet shown in FIG. 3;

FIGS. 6a and 6b are schematic views showing the structure of a sinus canal of the valve sinus canal of the artificial heart shown in FIG. 1;

FIGS. 7a and 7b are schematic cross-sectional views of the valve sinus tube of the artificial heart shown in FIG. 1;

FIG. 8 is a schematic structural view of a valve of one embodiment of a valve sinus tube of the prosthetic heart of the present application;

FIG. 9 is a schematic structural view of a sinus tube according to another embodiment of the present application;

FIG. 10 is a schematic structural view of an embodiment of a prosthetic heart valve sinus of the present application;

fig. 11 is a schematic view of the assembled prosthetic heart valve sinus tube of fig. 10.

Detailed Description

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Referring to fig. 1 and 2a and 2b, fig. 2a is a schematic view illustrating an angle of the sinus canal with valve of the artificial heart shown in fig. 1; FIG. 2b is a schematic view of the valve sinus tube of the artificial heart shown in FIG. 1 at another angle, wherein only one leaflet is shown;

the heart valve sinus canal 500 includes a valve 100 and a sinus canal 200, and the valve 100 is attached to the inner surface of the sinus canal 200 and connected to the sinus canal 200. The valve 100 includes three leaflets 10, the three leaflets 10 being disposed around the axis of the sinus tube 200 and being connected to each other. The sinus tube 200 includes a proximal end and a distal end. The heart valve sinus tube 500 is made of a high-strength high-molecular polymer material, a fiber, or other flexible material. For example, the valve leaflet 10 is made of a polyester material as the sinus canal 200 and a polyurethane material.

In this embodiment, three leaflets 10 are accommodated in the sinus tube 200, and are disposed around the center line A-A of the sinus tube 200, and the three leaflets 10 are rotationally symmetrical at A-A. Three leaflets 10 are connected to the inner face of the main tubular body 21. The three leaflets 10 open and close (close and open) to each other, as compared to the center line of the sinus tube 200, to supply blood to and to be interrupted. The specific connection locations of the three leaflets 10 to the main tubular body 21 will be described in detail later herein. The center line A-A of the sinus tube 200 in this embodiment is the axis of the sinus tube 200.

Referring to fig. 3, 4 and 5 together, fig. 3 is a schematic view of the leaflet of the prosthetic heart valve shown in fig. 1; FIG. 4 is a schematic view of the valve leaflet of FIG. 3 at an angle; fig. 5 is a schematic view of another angle of the leaflet shown in fig. 3.

The leaflet 10 is a thin sheet, and the leaflet 10 includes a leaflet body 11, a first coaptation edge 13, and a second coaptation edge 15, the first coaptation edge 13 and the second coaptation edge 15 being connected to opposite sides of the leaflet body 11. In this embodiment, the leaflet 10 is symmetrical in structure and symmetrical about the O-O plane. Wherein the first butt joint edge 13 and the second butt joint edge 15 are connected in an included angle and are symmetrical with each other by an O-O plane; the petals 11 are symmetrical about the O-O plane. The leaflet 10 further includes a ventricular surface 101 and an aortic surface 102, the ventricular surface 101 and the aortic surface 102 being disposed opposite.

The petals 11 are sheet-like bodies, generally in the shape of petals, such as rose petals, or petals similar to the rose petals. The flap 11 includes a first side 111 and a second side 112, and an attachment rim 113. The attachment rim 113 connects the first side 111 and the second side 112. The first side 111 and the second side 112 are connected and angled toward the aortic surface 102.

The valve body 11 further comprises a first sub-ventricular surface 114 and a first sub-aortic surface 115, the first sub-ventricular surface 114 and the first sub-aortic surface 115 are arranged back to back, the first sub-ventricular surface 114 is a convex cambered surface, and the first sub-aortic surface 115 is a concave cambered surface. The attachment edge 113, the first side 111 and the second side 112 each connect a first sub-ventricular surface 114 and a first sub-aortic surface 115.

It will be appreciated that the valve body 11 has a thickness, with the first side 111 and the second side 112 being smaller area faces and the first sub-ventricular face 114 and the first sub-aortic face 115 being larger area faces.

The valve body 11 is further formed with a leaflet base 12, the leaflet base 12 being located on a side of the valve body 11 remote from the attachment edge 113 and adjacent to the junction of the first side 111 and the second side 112, the leaflet base 12 being recessed from the first sub-aortic surface 115 towards the first sub-ventricular surface 114, i.e. protruding from the first sub-ventricular surface 114. The valve body 11 is in an O-O plane symmetrical structure, the first side 111 and the second side 112 are in an O-O plane symmetry, and the valve leaflet base 12 is in an O-O plane symmetry.

In practice, the first side 111 and the second side 112 are close to each other and both slope towards the O-O surface, corresponding to the curved shape of the valve body 11 towards the O-O surface, so that the valve body 11 forms said leaflet base 12. It is understood that the first side 111 and the second side 112 are connected at an angle to accommodate the convex orientation of the leaflet base.

In this embodiment, the first engaging edge 13 and the second engaging edge 15 are triangular plates, and the first engaging edge 13 and the second engaging edge 15 are respectively connected to the first side 111 and the second side 112; and at the position of the included angle between the first side 111 and the second side 112, one corner of the first butt joint edge 13 is connected with one corner of the second butt joint edge 15; and the junction of the first coaptation edge 13 and the second coaptation edge 15 is located on one side of the leaflet base 12. It is understood that one corner of the first mating edge 13 and the second mating edge 15 is connected to the junction of the first side edge 111 and the second side edge 112.

The first pair of engagement edges 13 includes a first free side 131 and a first free edge 132, the first free side 131 and the first free edge 132 being connected, and the first free side 131 being remote from the flap 11, the first free edge 132 being connected to the attachment edge 113. The second mating edge 15 includes a second free side 151 and a second free edge 152, the second free side 151 and the second free edge 152 being joined, and the second free side 151 being distal from the flap 11, the second free edge 152 being joined to the attachment edge 113. The first free side 131 of the first coaptation edge 13 connects to the second free side 151 of the second coaptation edge 15, and the connection is adjacent to the leaflet base 12. The part of the support at the joint of the leaflet base 12 and the connecting part is a butt joint part G.

The first coaptation edge 13 includes a second sub-ventricular surface 133 and a second sub-aortic surface 134 facing away from the second sub-ventricular surface 133. The second coaptation edges 15 each include a second ventricular surface 153 and a second aortic sub-surface 154 facing away from the second ventricular surface 153. The first and second coaptation edges 13 and 15 are disposed at an angle with respect to the O-O surface, and the second ventricular surface 133 of the first coaptation edge 13 and the second ventricular surface 153 of the second coaptation edge 15 are both inclined toward the O-O surface. Ventricular surface 101 is formed by first sub-ventricular surface 114, second sub-ventricular surface 133, and second sub-aortic surface 154, and aortic surface 102 is formed by first sub-aortic surface 115, second sub-aortic surface 134, and second sub-aortic surface 154.

It will be appreciated that the valve body 11, the first coaptation edge 13, and the second coaptation edge 15 of the leaflet 10 are integrally formed.

Fig. 6a and 6b, fig. 6a and 6b are schematic views of different angles of an embodiment of the sinus tube of the heart valve sinus tube shown in fig. 1. Sinus tube 200 is a hollow tube body open at both ends and includes a main tube body 21 and a ventricular aortic transition section 23, wherein a sinus tube interface section 25 is also connected to main tube body 21. The main tubular body 21 connects between a ventricular aortic transition section 23 and a sinotubular junction section 25. Ventricular aortic transition section 23 is proximal to the heart and sinus canal junction section 25 is distal to the heart when heart valve sinus canal 500 is accessed to the human heart. The end of ventricular aortic transition section 23 facing away from main body 21 is proximal edge 231 and the end of sinus ostium section 25 facing away from main body 21 is distal edge 251. It will be appreciated that the ventricular aortic transition section 23 and the sinus ostium section 25 are used for regions sutured to the blood vessel.

In this embodiment, main tube 21 includes a first port edge 213 and a second port edge 214 along the length of main tube 21, with first port edge 213 being used to connect ventricular aortic transition section 23 and second port edge 214 being used to connect sinus tube interface section 25. Ventricular aortic transition section 23 and sinus ostium section 25 may be joined by stitching with main body 21 or may be integrally formed with main body 21.

In this embodiment, the main tube 21 is a hollow tube with two open ends, and includes three sinus bodies 22, and the three sinus bodies 22 are located between the first mouth edge 213 and the second mouth edge 214. The three sinus bodies 22 protrude outward of the main tubular body 21 away from the center line A-A of the sinus tube 200, and the three sinus bodies 22 are disposed around the center line A-A of the main tubular body 21; the three sinus bodies 22 are equally distributed along the cross section of the main tubular body 21, and it is also understood that the three sinus bodies 22 are rotationally symmetrical about the center line A-A of the sinus tube 200 with a rotational symmetry angle of 120 degrees.

Each sinus body 22 projects away from the central axis O toward the exterior of the main tubular body 21 and has a central plane S about which each sinus body 22 is mirror-symmetrical. Specifically, dou Ti is generally convex hull-shaped and has an arc-shaped cross section (parabolic or bezier curve); the three sinus bodies 22 are protruded from the pipe wall of the main pipe body 21 along the radial direction and in the direction far away from the central line A-A, so as to form a convex hull shape protruded outside the main pipe body 21; the cavity inner face 221 of Dou Ti is a convex arcuate face away from the centerline A-A.

In addition, each sinus body 22 includes a leaflet attachment edge 222 and two leaflet She Jiaojie attachment edges 223. The leaflet attachment edge 222 is mirror symmetric about the central plane S. The leaflet attachment edge 222 is near the proximal end. Two petals She Jiaojie attachment edges 223 each extend from a proximal end to a distal end and connect opposite ends of the leaflet attachment edges 222, respectively. The two lobes She Jiaojie attachment edges 223 are mirror symmetrical about the central plane S. Wherein, in two adjacent sinus bodies 22, the attachment edge 223 of one valve She Jiaojie of one sinus body 22 coincides with the attachment edge 223 of one valve She Jiaojie of the other sinus body 22. The leaflet attachment edge 222 and the two petals She Jiaojie attachment edges 223 are actually the joining locations of the sinus body 22 and the main body, with the contour line being the joining contour, and the contour of the leaflet attachment edge 222 being the same as the attachment edge contour.

Referring again to fig. 2a, the heart valve sinus canal of the first embodiment is formed by assembling the three valve leaflets 10 and the sinus canal 200. That is, the three valve leaflets 10 are three independent individuals and are fixedly connected in the sinus tube 200 respectively, and the sinus tube 200 is formed independently and integrally, the three valve leaflets 10 are mounted in the main tube body 21 of the sinus tube 200, specifically, are connected to the cavity inner surface 221 of the main tube body 21, and each valve leaflet 10 corresponds to one sinus body 22; and three individual leaflets 10 surround the center line of the sinus tube 200.

The ventricular surface 101 of each leaflet 10 faces the proximal end of the sinus tube 200, and the aortic surface 102 of each leaflet 10 faces the distal end of the sinus tube 200 and is spaced from and disposed opposite the luminal surface of the sinus tube 200. The attachment edge 113 is connected to the luminal surface 221 of the main body 21, the attachment edge 113 of the valve body 11 in each leaflet 10 is connected to the leaflet attachment edge 222 of one sinus body 22, and the first free edge 132 of the first coaptation edge 13 and the second free edge 152 of the second coaptation edge 15 correspond to the two leaflet She Jiaojie attachment edges 223 of one sinus body 22, respectively. I.e. the attachment edge 113 is connected to a partial contour line Dou Ti (by stitching). The first free side 131, the first free edge 132, the second free side 151, and the second free edge 152 are cantilevered compared to the centerline of Dou Ti. It should be noted that the attachment edge 113 of each two leaflets 10 is fixedly connected between each two adjacent sinus bodies 22, that is, at a position where the contour lines of each two adjacent sinus bodies 22 are connected.

Inside the sinus tube 200, one leaflet 10 forms a substantially semi-pocket structure with one sinus body 22, three leaflets 10 are butted around the central line A-A of the sinus tube 200, the butted portions G of the valve bodies 11 of the three leaflets 10 are butted against each other, the leaflets 10 are prevented from sagging axially along the sinus tube 200, the first pair of coaptation edges 13 of the three leaflets 10 and the second pair of coaptation edges 15 of the adjacent other leaflet are butted against each other, the first free side edge 131 of one leaflet 10 is butted against the second free side edge 151 of the other leaflet 10, and the first free edges 132 and the second free edges 152 of the three leaflets 10 are suspended and butted against the sinus body 22. The leaflet 10 of the present embodiment is independently installed in the sinus canal 200, and the leaflet 10 does not require too many reserved connection areas, and each leaflet 10 and sinus body 22 can be precisely aligned.

The above connection between two separate objects (such as the leaflet 10 and the sinus tube 200) includes stitching, ultrasonic welding, bonding, pressing, etc., which are not described.

In this embodiment, the valve leaflet base 12 protrudes toward the sinus tube 200, and when there is a backflow of blood at the distal end of the sinus tube 200, the flow is reversed along the inner surface of the sinus tube 200, and a blood split flow is formed, and the split flow flows into the valve leaflet base 12 through the first sub-aortic surface 115, and a force is generated to push the valve body 11 of the valve leaflet 10 to deform toward the center direction of the sinus tube 200, and the three valve leaflets 10 are closed each other; blood continues to flow proximally toward the distal end, striking the first ventricular surface 114, deforming the three leaflets 10 away from each other, i.e., opening. During blood flow, the three leaflets 10 are repeatedly impacted by the returning blood to open and close.

That is, when the heart works, the blood is pulsed to impact the valve 100, and when the blood flows from the proximal end to the distal end, the three leaflets 10 are pushed from the ventricular surface direction, so that the three leaflets 10 are deformed away from each other, and the first and second pair of edges 13, 15 of the three leaflets 10 are opened, that is, the first free side edge 131, the first free edge 132, the second free side edge 151 and the second free edge 152 of the three leaflets 10 are separated from each other. When the blood flow flows forward and impinges on the upper part of the sinus body, a backflow of blood is generated, and the backflow of blood flows along the wall of the sinus body 22 toward the proximal end, acts on the aortic surface 102 of the valve leaflet to push the valve body 11 of the valve leaflet 10 to deform toward the center direction of the sinus tube 200, and the first free side 131, the first free edge 132, the second free side 151 and the second free edge 152 are re-coaptated, thereby closing the three valve leaflets 10 close to each other, i.e., the valve 100 reciprocates in the opened and closed states. The blood flow from the ventricle to the aorta acts on the ventricle chamber of the valve leaflet, the thrust force formed by the blood flowing back in the sinus acts on the aortic surface of the valve leaflet, and the pressure between the two determines the opening and closing of the valve leaflet.

The aortic valve of the human body is located between the left ventricle and the aorta, and opens as the left ventricle contracts to pump blood into the aorta, through which it is supplied to the whole body. When the heart valve-equipped sinus tube 500 is inserted into the heart of a human body, the ventricular ejected blood flows from the proximal end of the valve-equipped sinus tube toward the distal end, and there is a short backflow of blood in the sinus tube 200 (which can be understood as a flow of blood in the opposite direction to the central flow direction of the sinus tube at the level of contact with the sinus wall), the pressure difference generated by the blood flow is controlled to control the closing of the three leaflets 10, that is, when the force generated by the forward flow is greater than the force generated by the reverse flow in the sinus, the valve She Kaifang; conversely, the valve She Guanbi) the forward blood vessel in the sinus tube 200 pushes the leaflets 10 open, the pressure difference between the forward flow in the sinus tube 200 and the reverse flow in Dou Ti controls the closing of the leaflets 10, the blood flows from the proximal end toward the distal end in the sinus tube 200, the backflow of blood flows toward the proximal end along the inner surface (the inner cavity) of the sinus tube 200, and the backflow of blood flows less with less force to the leaflets 10, the three leaflets 10 are understood as closing each other along the surface of the leaflets 10 _， The final opening or closing exhibited by the leaflet 10 depends on the pressure differential between the central forward blood vessel of the sinus tube 200 and the reverse blood vessel in Dou Ti. If the reverse blood flow pressure in Dou Ti is higher than the pressure developed by the forward blood flow in the sinus tube 200, the leaflet 10 closes; if the pressure of the central blood flow in the sinus tube 200 is higher than the reverse blood flow in Dou Ti 22The resulting pressure opens the leaflet 10. Since this pressure difference is small, the leaflet 10 receives less impact force, and the service life of the leaflet 10 is prolonged.

Referring to fig. 7a and 7b, the proximal end of the sinus tube 200 has a tube radius R, and the proximal end refers to the end of the sinus tube 200 that is proximal to the heart during use.

The distal end of the sinus tube 200 has a tube radius r and the distal end refers to the end of the sinus tube 200 that is distal from the heart during use.

The following heights refer to angles of the heart valve sinus tube 500 during use, and generally refer to a vertical direction, a direction in which blood flows, and an actual dimension is a length dimension.

The coaptation height is C, which is the length of the coaptation positions of the three leaflet coaptation regions G along the axial direction of the sinus canal 200 in the closed state of the three leaflets.

The sinus Guan Zonggao of the valved sinus tube 500 is Hh and the total sinus tube height refers to the length dimension of the sinus tube 200 in the axial direction, i.e., the sum of the lengths of the sinus body 22, the ventricular aortic transition section 23, and the sinus tube junction section 25.

Dou Gao is hs, dou Gao is the length of Dou Ti in the axial direction of the sinus ostium 200.

The suspension height HS is the length of the positions where the first free edge 132 and the second free edge 152 of the leaflet 10 abut the Dou Ti 22 (the length of the first free edge 132 and the second free edge 152) in the axial direction of the sinus tube 200.

Dou Banjing is ds, and the sinus radius refers to the radial distance from the highest point of curvature of the sinus body 22 to the centerline of the sinus tube 200.

The total height of the leaflet is h, which refers to the length dimension of the leaflet 10 in the axial direction of the sinus canal 200.

The band transition segment Dou Zonggao is H, and the sum of the lengths of the sinus ostium segment 25 and the sinus body 22 in the axial direction of the sinus tube 200.

The valve elevation angle is α, and the valve body 11 (first ventricular surface 114) is at an angle to the horizontal when the leaflet 10 is closed.

The leaflet edge downtilt angle is β, which is the angle between the leaflet edge (aortic surface) and the axial direction of the sinus tube 200 in the leaflet open state. Where 10a is the position of the leaflet 10 in the open position.

As shown in fig. 7a and 7b, in this embodiment, specific values of the above dimensions are r=1, c=r (0.2 to 0.5), hs=r (0.3 to 0.8), h=r (1 to 1.5), hs=r (1.2 to 2.1), h=r (1.5 to 2.4), hh=r (1.7 to 3), ds=r (1.1 to 2), r=r (0.8 to 1.1), α=r (13 ° to 25 °), and β=r (25 ° to 40 °). Under these conditions, the shape of the leaflet 10 is brought close to the actual valve of the human body. The cooperation of the three leaflets 10 can fully fulfil the function of a valve of the human body. Wherein, reasonable setting of the elevation angle of the valve can lead the valve to have optimal stress and maximum effective opening area, and lead the stroke angle of opening and closing of the valve blade 10 not to be too large or too small, namely limit the stroke of the valve blade 10, thus prolonging the service life of the valve blade 10.

The valve leaflet 10 adopted by the heart valve sinus tube 500 of the embodiment of the application can be rapidly closed after blood passes, so that the backflow of the blood is prevented, and further, the heart failure caused by the increase of the ventricular preload is avoided.

Based on the above embodiments, the cardiac valve sinus tube 500 of the present application is formed in the following manner.

Referring to fig. 8 and 9, fig. 8 is a schematic structural view of a valve according to an embodiment of the prosthetic heart valved sinus tube of the present application; fig. 9 is a schematic structural view of a sinus tube according to another embodiment of the present application. In a second embodiment of the heart valve sinus tube 500 of the present application, the heart valve sinus tube 500 includes the valve 100 and the sinus tube 200, the valve 100 includes the three valve leaflets 10 of the above-mentioned embodiment, and the valve of the present embodiment further includes a connecting tube 18, and the three valve leaflets 10 are connected to one end of the connecting tube 18. The sinus tube 200 includes a main tubular body 21 and a ventricular aortic transition section 23, i.e., the sinus tube juncture 25 is not provided. The valve 100 is mounted in the sinus tube 200 and coaxially disposed, and the connecting tube 18 is connected to the ventricular aortic transition section 23.

Specifically, the connection pipe 18 includes a pipe body 181 and a connection portion 182, the pipe body 181 is a cylinder with two open ends, the connection portion 182 is formed at an open end edge of the pipe body 181, the connection portion 182 is an annular structure with three spaced curved interfaces 183, the connection portion 182 surrounds a center line of the connection pipe 18, and the curved interfaces face away from the pipe body 181. The connection area between the pipe body 181 and the connection part 182 is a connection edge, and is used for being connected with the pipe body.

Three valve blades 10 are respectively arranged at the positions of the curved surface interfaces 183, the three valve blades 10 are butted around the central line of the connecting pipe 18, and the attaching edge 113 of each valve blade 10 is connected with the connecting part 182 of the connecting pipe 18; the aortic surfaces 102 of the three leaflets 10 are disposed away from the centerline of the connecting tube 18. The first and second coaptation edges 13, 15 of the three leaflets 10 are sequentially spaced about the centerline of the connecting tube 18, with the first coaptation edge 13 of one leaflet 10 and the second coaptation edge 15 of an adjacent other leaflet 10 opposing each other, the second ventricular surface 133 of the first coaptation edge 13 opposing the second ventricular surface 153 of the second coaptation edge 15, and the first free side 131 of one leaflet 10 opposing the second free side 151 of the other leaflet 10. It is understood that the connecting tube 18 is the body of the valve 100 to support the three leaflets 10.

Sinus tube 200 includes a main body 21 and a ventricular aortic transition section 23, with main body 21 being connected to one end of ventricular aortic transition section 23. The main pipe body 21 has exactly the same structure as the main pipe body 21 of the above embodiment. The end of ventricular aortic transition section 23 facing away from main tubular body 21 is the proximal end. In this embodiment, the ventricular aortic transition section 23 is a circular tube body, and its inner diameter is larger than the outer diameter of the connecting tube 18, and it is ensured that the ventricular aortic transition section 23 is tightly matched with the connecting tube when it is sleeved on the inner peripheral surface of the connecting tube 18. The connection tube 18 may be joined to the ventricular aortic transition portion 23 by suturing, ultrasonic welding, bonding, and crimping. In this embodiment, the main pipe body 21 has the same structure as that of the main pipe body of the first embodiment, and a detailed description thereof will be omitted.

Wherein the valve 100 is formed as a single piece and the sinus tube 200 is formed as a single piece, the single piece including woven or injection molded _。 After the valve 100 is installed in the sinus tube 200, the outer peripheral surface of the tube body 181 of the connecting tube 18 is attached to the outer peripheral surface of the ventricular aortic transition section 23, and the connecting tube 18 and the ventricular aortic transition section 23 are connected by stitching or the likeThe attachment edges 113 of the three valve leaflets 10 correspond to the first junction surface of the sinus body 22 to form a heart valved sinus tube 500 shown in fig. 1, wherein the aortic surface 102 faces Dou Ti and the proximal end and the aortic surface 102 smoothly transitions with the luminal surface 221 of the sinus body. The valve 100 and the sinus tube 200 of the present embodiment are formed separately and then assembled, so that the assembly accuracy can be improved.

The dimensions of the sinus body and the leaflet in the present embodiment conform to the various relevant conditions of the first embodiment, and particularly refer to fig. 7a and 7b, which are not repeated here.

The above connection manner between two independent objects (such as the leaflet 10, the valve 100, the sinus tube 200) includes stitching, ultrasonic welding, bonding, pressing, and the like, which are not described one by one.

Referring to fig. 10 and 11, in a third embodiment, a heart valve sinus tube 500 includes three valve sinus tube bodies 500a, and the three valve sinus tube bodies 500a are butt-stitched to form the heart valve sinus tube 500. The valve sinus tube 500a is integrally formed by weaving or injection molding. Each valve sinus tube 500a includes a sub-sinus tube 200a and one of the leaflets 10 described in the first embodiment above.

The sub-sinus tube 200a includes a sub-main body 201, a sub-ventricular aortic transition section 202, a sub-transition section 203, and one sinus body 22. The sub-transition section 203, sub-main body 201 and sub-ventricular aortic transition section 202 are connected in sequence along the length of the valve sinus tube 500 a. The valve sinus tube body 500a further includes a first connection part 501 and a second connection part 502, the first connection part 501 and the second connection part 502 being located at opposite sides of the sub-sinus tube 200a, and the first connection part 501 connecting one side of the sub-main tube body 201, the sub-ventricular aortic transition section 202 and the sub-transition section 203 in the length direction of the valve sinus tube body 500 a; a second connection 502 connects the other side of the sub-main body 201, sub-ventricular aortic transition section 202, and sub-transition section 203. The first connection portion 501 and the second connection portion 502 have the same length dimension, and the first connection portion 501 and the second connection portion 502 have the same width dimension. The connecting edges of the first connecting portion 501 and the second connecting portion 502 connecting the main sub-tube 201, the main sub-ventricular aortic transition section 202 and the sub-transition section 203 are sewing edges.

Dou Ti in this embodiment is the same as the sinus structure of the first embodiment, and will not be described here.

The valve leaflet 10 is integrally formed with the sub-sinus tube 200a and is connected opposite to the sinus body 22; specifically, the attachment edge 113 is connected to the bonding edge (e.g., the bonding edge of the first embodiment) Dou Ti, and the first free side 131 and the second free side 151 are suspended. The aortic surface 102 of the leaflet 10 is spaced from the inner luminal surface of the sinus body 22, forming a scoop-like space between the leaflet 10 and the sinus body 22.

The first connection portion 501 of the first valve sinus tube body 500a is combined and fixedly connected with the second connection portion 502 of the second valve sinus tube body 500 a. The connection area between the first connection portion 501 of the first valve sinus tube 500a and the second connection portion 502 of the second valve sinus tube 500a may be a connection location between the first connection portion 501 of the first valve sinus tube 500a and the sub-sinus tube 200a of the first valve sinus tube 500a, that is, a suture edge, and a connection location between the second connection portion 502 of the second valve sinus tube 500a and the sub-sinus tube 200a of the second valve sinus tube 500 a. Specific connection modes include stitching, ultrasonic welding, bonding, pressing and the like. The three valve sinus cavities 500a are joined to form a heart valve sinus cavity 500 that is rotationally symmetric about a center line A-A. The dimensions of the sinus body and the leaflet in the present embodiment conform to the various relevant conditions of the first embodiment, and particularly refer to fig. 7a and 7b, which are not repeated here.

The foregoing disclosure is illustrative of the preferred embodiments of the present invention, and is not to be construed as limiting the scope of the invention, as it is understood by those skilled in the art that all or part of the above-described embodiments may be practiced with equivalents thereof, which fall within the scope of the invention as defined by the appended claims.

Claims

1. An artificial heart valve leaflet is characterized in that,

the artificial heart valve leaflet comprises an attachment edge, two free edges, a ventricular surface and an aortic surface, wherein the attachment edge is connected between the two free edges, the two free edges are connected, the ventricular surface and the aortic surface are arranged back to back, and are connected with the attachment edge and the two free edges,

the attachment edge is arc-shaped, the ventricular surface is concave, the aortic surface is convex formed after the ventricular surface is concavely arranged,

the artificial heart valve leaflet comprises a valve leaflet bottom and a butt joint part, wherein the butt joint part is connected with the first side and the second side of the valve leaflet bottom, the valve leaflet bottom is convexly arranged from an aortic surface to a ventricular surface direction, and the butt joint part is opposite to the attachment edge and is connected with the joint part of the free edges.

2. The prosthetic heart valve leaflet of claim 1, wherein the prosthetic heart valve leaflet comprises a valve body, a first coaptation edge and a second coaptation edge, the valve body comprising a first side, a second side, and the attachment edge connecting the first side and the second side, the first side and the second side being contoured to be straight and disposed at an included angle; the first and second mating edges are connected to the first and second sides, respectively;

3. The prosthetic heart valve leaflet of claim 2, wherein the first and second coaptation edges are triangular flaps, the first free side and the side of the first coaptation edge that connects to the valve body are long sides, and the second free side and the side of the second coaptation edge that connects to the valve body are long sides.

4. The prosthetic heart valve leaflet of claim 1, wherein the valve body comprises a first sub-ventricular surface and a first sub-aortic surface, the first sub-ventricular surface and the first sub-aortic surface being disposed facing away from each other, and the first sub-ventricular surface being a convex arc surface and the first sub-aortic surface being a concave arc surface;

5. The prosthetic heart valve leaflet of claim 2, wherein the prosthetic heart valve leaflet is symmetrical about a plane of symmetry passing through the valve body, the first side and the second side are symmetrical about the plane of symmetry, the leaflet base is symmetrical about the plane of symmetry, and the first coaptation edge and the second coaptation edge are symmetrical about the plane of symmetry.

6. A prosthetic heart valve comprising three prosthetic heart valve leaflets of any one of claims 1-5 and a connecting tube, wherein the attachment edges of the three prosthetic heart valve leaflets are connected to one end of the connecting tube, the centerlines of the three prosthetic heart valve She Weirao are disposed about the centerline of the valve, and the abutment portions of the three prosthetic heart valve leaflets abut each other about the centerline of the valve; the aortic surfaces of the three artificial heart valve leaflets face away from the central line of the connecting pipe; and in the two adjacent artificial heart valve leaflets, the first involution edge of one artificial heart valve leaflet is relatively attached and connected with one side of the second involution edge of the other artificial heart valve leaflet, which is away from the aortic surface.

7. The prosthetic heart valve of claim 6, wherein the connecting tube comprises a tube body and a connecting portion, the tube body being a cylinder with two open ends, the connecting portion being formed at an open end edge of the tube body, the connecting portion being a ring-shaped structure having three spaced curved interfaces, the connecting portion surrounding a centerline of the connecting tube, the curved interfaces facing away from the tube body;

8. An artificial heart valved sinus tube comprising the leaflet of any one of claims 1-5 and a sinus tube, the sinus tube comprising a main tubular body;

9. The prosthetic heart valved sinus tube of claim 8, further comprising a ventricular aortic transition segment and a transition segment, the ventricular aortic transition segment connected to the first port side, the transition segment connected to the second port side, the proximal end positioned at an end of the ventricular aortic transition segment facing away from the main tubular body, and the distal end positioned at an end of the transition segment facing away from the main tubular body.

10. The prosthetic heart valved sinus tube of claim 8, wherein the sinus body each includes a leaflet attachment edge and two valve She Jiaojie attachment edges, the two valve She Jiaojie attachment edges respectively connecting opposite ends of the leaflet attachment edges; the leaflet attachment edges are proximate the proximal end, and both of the leaflet She Jiaojie attachment edges extend from the proximal end toward the distal end; adjacent two of the Dou Tizhong, one of the petals She Jiaojie of one of the sinus bodies has an attachment edge that coincides with one of the petals She Jiaojie of the other sinus body, the leaflet attachment edges being mirror symmetrical about a central plane, and the two petals She Jiaojie attachment edges being mirror symmetrical about a central plane;

11. The prosthetic heart valved sinus tube of claim 8, wherein the leaflet is any one of sewn, ultrasonically welded, glued, and pressed with the main tubular body.

12. A prosthetic heart valved sinus tube comprising the prosthetic heart valve of claim 6 or 7 and a sinus tube comprising a main tubular body and a ventricular aortic transition section,

13. The prosthetic heart valved sinus tube of claim 12, wherein the tube body portion and the connecting tube connecting region are connecting edges, the connecting edges are connected to the ventricular aortic transition section, and the connecting means is any one of suturing, ultrasonic welding, adhesive bonding, and compression bonding.

14. An artificial heart valved sinus tube according to any one of claims 1-5, comprising an artificial heart valve leaflet and a sub-sinus tube, said sub-sinus tube comprising a sub-main tube body, a sub-ventricular aortic transition section, and a sinus body, said sub-ventricular aortic transition section being connected to one end of said sub-main tube body, said Dou Ti projecting away from an outer side of said sub-main tube body,

15. The prosthetic heart valved sinus tube of claim 14, wherein the sides of the first and second connection portions connecting the main sub-tubular body and the sub-ventricular aortic transition section are suture sides.

16. An artificial heart valved sinus tube comprising three artificial heart valved sinus tube bodies of claim 15; three artificial heart valves Dou Ti are enclosed, three sub-main pipe bodies are enclosed into a main pipe body and are rotationally symmetrical with the central line of the artificial heart valved sinus pipe, and valve leaves are positioned in the main pipe body and are rotationally symmetrical with the central line of the artificial heart valved sinus pipe; two adjacent prosthetic heart valves Dou Tizhong, the sewing edge of the first connecting portion of one of the prosthetic heart valves Dou Ti being opposite to and sewing the sewing edge of the second connecting portion of the other prosthetic heart valve Dou Ti, the first and second connecting portions of each prosthetic heart valve Dou Ti being located outside the main tubular body; the three leaflets are operative to switch between opening and closing one to the other and deform as the three leaflets open one to the other.

17. The prosthetic heart valved sinus tube of claim 16, wherein the abutment portions of three of said prosthetic heart leaflets abut each other along said centerline; the aortic surfaces of the three prosthetic heart valves Dou Ti face away from each other; the first coaptation edge of one prosthetic heart valve Dou Ti is attached and connected to the second coaptation edge of the other prosthetic heart valve Dou Ti opposite the aortic surface of two adjacent prosthetic heart valves Dou Tizhong.