CN112826637A

CN112826637A - a heart valve prosthesis

Info

Publication number: CN112826637A
Application number: CN201911156758.3A
Authority: CN
Inventors: 邱尧; 刘世红; 赵婧; 陈国明; 李�雨
Original assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Current assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Priority date: 2019-11-22
Filing date: 2019-11-22
Publication date: 2021-05-25

Abstract

The invention discloses a heart valve prosthesis, which comprises a support and valve leaflets, wherein the valve leaflets are arranged on the inner side of the support, the support comprises grid units formed by connecting support rods, the valve leaflets comprise at least two pieces of blades, each blade comprises a blade main body and a blade connecting part connected with the blade main body, each blade connecting part is provided with a first connecting part and a second connecting part, a first turnover position is formed at the junction of the first connecting part and the blade main body, a second turnover position is formed at the junction of the first connecting part and the second connecting part, each blade is connected with an adjacent blade through the first connecting part which is turned over along the first turnover position, and each blade is connected with the support through the second connecting part which is turned over along the second turnover position. The connection mode of the valve leaflet and the support of the heart valve prosthesis provided by the invention does not cause adverse effect on the heart valve prosthesis.

Description

Heart valve prosthesis

Technical Field

The invention relates to an interventional medical prosthesis, in particular to a heart valve prosthesis.

Background

With the increase of human life and the aging of human population, the incidence of valvular heart disease is higher and higher. According to literature statistics, valvular disease exists in 2-7% of the elderly aged over 65 years old. In the European and American countries, the incidence of valvular disease is third after coronary heart disease and hypertension.

Heart Valve prostheses (Heart Valve prostheses), also known as prosthetic Heart valves, are artificial organs that can be implanted in the Heart in place of the native Heart valves (including the aortic, pulmonary, tricuspid and mitral valves), enable unidirectional blood flow, and function as the native Heart valves. Interventional heart valve replacement is necessary when heart valve disease is severe and valve separation surgery is not possible, nor is a repair surgery to restore or improve valve function.

Interventional heart valve replacement is a treatment for controlling and placing a heart valve prosthesis at a lesion site by a delivery system through a minimally invasive procedure.

Due to the complexity of the native structure of the mitral valve, the design of mitral valve prostheses is difficult, mainly represented by:

1. the mitral annulus has a large area and the leaflets have high difficulty in closing: the artificial valve prosthesis has certain requirements on the contact area of the valve and the valve leaflet after being closed, and the sufficient contact area of the valve leaflet can effectively prevent blood backflow and overlarge trans-valve pressure difference. The cross-valve pressure difference is the most important hemodynamic parameter for evaluating the function of the artificial heart valve, and the larger the cross-valve pressure difference is, the larger the velocity gradient of the blood flow is, and the larger the shear stress generated by the velocity gradient is. If the shear stress exceeds a threshold that causes damage to blood components, hemolysis or sub-hemolysis may occur, and even damage to vascular endothelial cells may result.

2. The leaflet and stent are poorly attached: compared with the surgery, the heart valve prosthesis for the intervention operation generally adopts a self-expansion type or a ball expansion type bracket, the mechanical property of the bracket is relatively poor, and the connection between the valve leaflet and the bracket can be influenced, so that the stability of the valve is influenced. Some designs enhance the connection of the leaflets to the stent by adding additional attachment structure to the stent, which can cause stress concentrations in the leaflets and, in severe cases, damage to the leaflets. Some designs increase the connection strength between the leaflets and the stent by changing the original structure of the stent, which may adversely affect the mechanical properties of the stent itself.

3. Because the internal environment is complex, the requirement on the structural stability of the artificial heart valve is high: the mitral valve native valve ring is saddle-shaped, and the contraction and relaxation forms are not balanced, so that the working condition of the artificial heart valve in vivo is unstable. In addition, there are many other structures near the native mitral valve structure, such as papillary muscles, chordae tendineae, ventricular walls, etc., which affect the morphology and range of motion of the prosthetic heart valve in vivo.

In conclusion, the mitral valve leaflet has high closing difficulty and poor connection stability between the leaflet and the stent, and the improvement of the stability of the mitral valve prosthesis under complex working conditions is a difficult problem to be solved urgently in the field of intervention of the mitral valve.

Disclosure of Invention

The invention aims to provide a heart valve prosthesis, which solves the problems of poor connection stability of valve leaflets and a support and high risk of damage of the valve leaflets and improves the stability of the heart valve prosthesis in a motion state.

The technical scheme adopted by the invention for solving the technical problems is to provide a heart valve prosthesis, which comprises a stent and valve leaflets, the valve leaf is arranged at the inner side of the bracket, the bracket comprises grid units formed by connecting bracket rods, wherein the leaflet comprises at least two blades, the blades comprise a blade main body and a blade connecting part connected with the blade main body, the blade connecting part is provided with a first connecting part and a second connecting part, a first turnover position is formed at the junction of the first connecting part and the blade main body, a second turnover position is formed at the junction of the first connecting part and the second connecting part, the blade is connected with the adjacent blade through the first connecting part turned over along the first turnover position, the blades are connected with the support through the second connecting parts which are folded along the second folding positions.

Preferably, at the connection position of the blade and the adjacent blade, the first connection part is located at the outer side of the blade main body, and the inner sides of the blade main body are mutually attached and connected with the first connection part at the outer side of the blade main body.

Preferably, the second connecting portion has an outer edge fixedly connected to a bracket rod of the bracket.

Preferably, an included angle between a plane where the second connecting part is located after being folded along the second folding position and a plane where the first connecting part is located after being folded along the first folding position is smaller than or equal to 90 degrees.

Preferably, the heart valve prosthesis comprises a skirt fixedly attached to an inner surface of the stent.

Preferably, the blade connecting portion comprises a blade outward-turning portion, a third turning position is formed at the junction of the blade outward-turning portion and the second connecting portion, and the blade is connected with the bracket and the skirt through the blade outward-turning portion turned along the third turning position.

Preferably, the leaf eversions are disposed within the voids defined by the grid cells.

Preferably, the heart valve prosthesis comprises a plurality of leaflet connecting pieces, the leaflet connecting pieces cover the leaflet connecting parts and wrap the support rods at the connecting parts of the leaflet connecting parts and the support, and the leaflet connecting pieces are positioned on the outer side of the support.

Preferably, the leaflet connecting piece includes a connecting piece lower edge aligned with the third folding position and a connecting piece sewing portion connected with the support rod and the second connecting portion.

Preferably, the leaflet has a leaflet free edge and a leaflet sewing edge, and the leaflet is connected with the support by sewing along the inner wall of the support and along the matched curve of the leaflet sewing edge from the leaflet connecting sheet.

Preferably, the vane has a vane free edge and a vane sewing edge, the number of the vane connecting parts of each vane is two, and the two vane connecting parts are axisymmetrically arranged at the junction of the vane free edge and the vane sewing edge.

Compared with the prior art, the invention has the following beneficial effects: according to the heart valve prosthesis provided by the invention, the blade connecting parts are ingeniously arranged on the blades and are connected with the bracket after being turned over, so that the auxiliary structure of the bracket is not increased, the structure of the bracket is not changed, and the heart valve prosthesis at least has the following advantages: firstly, the valve leaflets are connected with the support and the skirt edge in a turnover mode, the auxiliary structure of the support is not increased, the structure of the support is not changed, the valve leaflets are prevented from being damaged due to stress concentration, and adverse effects on the heart valve prosthesis are avoided; secondly, two adjacent blades are connected together in a mode of folding the blade connecting part, so that the valve blades can be effectively closed and do not return, and when the valve blades are opened, the connecting parts of the adjacent blades, except the valve blades, the skirt edges and the support, do not have other hard structures, so that the valve blades can have larger effective opening area and provide more excellent fluid mechanical property for the heart valve prosthesis; and thirdly, the valve leaflet connecting sheet can be used for performing auxiliary connection on the valve leaflets, the support and the skirt edges, so that the connection strength of the connection positions of the adjacent valve leaflets of the valve leaflets is enhanced, the support rods at the connection positions are covered, the suture lines are prevented from being broken by the support, and the valve leaflets are prevented from being damaged when the heart valve prosthesis is sheathed.

Drawings

FIG. 1 is a schematic diagram of the overall structure of a heart valve prosthesis according to an embodiment of the present invention;

FIG. 2 is an enlarged partial perspective view of a heart valve prosthesis having leaflet attachment portions according to an embodiment of the present invention;

FIG. 3 is a schematic structural view of a heart valve stent according to an embodiment of the present invention;

FIG. 4 is a flat expanded view of a blade in an embodiment of the present invention;

FIG. 5 is a schematic view of a blade attachment portion according to an embodiment of the present invention;

6a, 6b and 6c are respectively schematic structural diagrams of blade connecting parts with three different shapes in the embodiment of the invention;

FIG. 7 is a schematic view of a heart valve leaflet after attachment, according to an embodiment of the present invention;

FIG. 8a is a schematic view of another embodiment of the present invention showing the leaflets of a heart valve attached;

FIG. 8b is an enlarged view of area A of FIG. 8 a;

FIG. 9 is a schematic representation of the lay-flat of the skirt of the heart valve prosthesis according to an embodiment of the invention;

fig. 10a and 10b are schematic views of two different shapes of leaflet webs according to embodiments of the present invention.

In the figure:

1 rack 11 inflow 12 transition section 13 outflow

14 grid cell 421 cradling piece

2 leaflet 20 leaflet 21 leaflet connecting part 22 leaflet sewing edge

23-vane free edge 211 first fold-over position 212 second fold-over position 213 third fold-over position

214

upper edges

215, 215a, 215b, 215c second connection portions

216. 216a, 216b, 216c outer edge 24 blade body

217. 217a, 217b, 217c leaf eversion

218 first connecting part 3 skirt 30 skirt 31 skirt upper edge

32 skirt lower edge 33 skirt connection 4 leaflet connection

41

leaflet connecting piece

412a, 412b connecting piece lower edge

413a, 413b connecting the piece sewn portion

Detailed Description

The invention is further described below with reference to the figures and examples.

Unless otherwise specified, the terms "valve", "prosthetic valve" and "valve prosthesis" as used herein refer to prosthetic valve prostheses, including at least the stent, leaflets and the junction therebetween, and the skirt, if present. As used herein, "leaflet" refers to the collective set of all leaflets on a prosthetic valve prosthesis. "leaflet" as used herein refers to one of the "leaflets". The prosthetic valve prosthesis of the present embodiment may also be applied to valves other than the mitral valve. The terms "inner", "outer", "upper", "lower" and the like are used herein for illustrative purposes only and do not represent the only embodiments, and "axial" as used herein refers to the direction in which the axis of the stent is located.

Referring to fig. 1, the heart valve prosthesis provided in this embodiment includes a stent 1, a leaflet 2 and a skirt 3, and in a preferred embodiment, the heart valve prosthesis further includes a leaflet connecting portion 4.

Referring to fig. 3, the stent 1 has three portions, i.e., an inflow channel 11, an outflow channel 13 and a transition section 12, wherein the inflow channel 11, the transition section 12 and the outflow channel 13 are connected in sequence in the axial direction, and the outflow channel 13 is located downstream of the inflow channel 11 according to the direction of blood flow. The inflow tract 11 corresponds to the part of the blood that flows into the stent 1 during the operation of the valvular prosthesis, and the outflow tract 13 corresponds to the part of the blood that flows out of the stent 1 during the operation of the valvular prosthesis. The stent 1 comprises grid cells 14 formed by connecting stent struts, wherein the grid cells 14 are generally diamond-shaped, and can be in other suitable shapes, such as pentagonal, hexagonal and the like cells which can form a closed shape. The stent 1 is made of shape memory alloy material, preferably nickel titanium metal material.

The leaflets 2 are disposed inside the stent 1 and skirt 3. The material of the valve leaflet 2 is generally biological material or high molecular material, preferably biological material, more preferably bovine pericardium or porcine pericardium material. The leaflet 2 comprises at least two blades 20, the number of the blades 20 is preferably 3, and the blades are uniformly distributed in the circumferential direction of the stent 1. After the heart valve prosthesis is implanted into a human body, the valve leaflets 2 can be opened and closed to play the role of one-way valves, specifically, when the valve leaflets 2 are opened, blood in the left atrium can flow into the left ventricle, and when the valve leaflets 2 are closed, the blood in the left ventricle can not flow into the left atrium.

Fig. 4 is a flat developed view of the blade 20.

Referring to fig. 4, the vane 20 of the present embodiment comprises a vane main body 24 and two vane connecting portions 21, the vane main body 24 has a vane free edge 23 and a vane sewing edge 22, and the vane sewing edge 22 is connected, preferably by sewing, to the skirt 3 and the bracket 1 at the transition section 12 and the outflow channel 13 of the bracket 1. Specifically, the leaflet 2 is attached to the stent 1 and the skirt 3 by suturing from the leaflet attachment portion 4 along a curved line on the inner wall of the stent 1 that matches the leaflet suturing edge 22. The free edges 23 of the leaflets are the coaptation areas when the leaflets close, where there is no suture, and when the leaflets close, the contact between adjacent leaflets 20 ensures effective closure of the leaflets and prevents regurgitation. Preferably, two vane connecting parts 21 are axially symmetrically arranged at the junction of the vane free edge 23 and the vane sewing edge 22, and two adjacent vanes 20, vanes 20 and skirt 3, vanes 20 and bracket 1 are respectively connected together by folding and sewing the vane connecting parts 21. The blade connecting portion 21 is a connecting portion of two adjacent blades 20, and is used for ensuring the accuracy of the involution of the two blades 20, so as to ensure the opening and closing performance of the blades 20.

Referring to fig. 5, the blade connecting portion 21 specifically includes: a first connecting portion 218 for connecting two adjacent blades 20; a second connecting portion 215 for connecting the leaflet 2, skirt 3 and stent 1; and a blade evagination 217 connected to the skirt 3. The blade eversion portion 217 can increase the connection strength of the leaflet 2 and the stent 1, and the edge of the blade 20 connected above the first connection portion 218 and the second connection portion 215 is the upper edge 214 in the flat unfolded state, and the second connection portion 215 also has the outer edge 216. Fig. 6a to 6c show three embodiments of the blade connecting portion 21, the shapes of the first connecting portion 218, the second connecting portion 215, and the outwardly turned portion 217 may be other shapes than those shown in fig. 6a to 6c, and the shape of the first connecting portion 218, the second connecting portion 215, and the blade outwardly turned portion 217 is not particularly limited in this embodiment. Preferably, the blade outward-turning parts 217 are matched with the shapes of the vacant spaces in the grid cells 14, so that the blade outward-turning parts 217 are arranged in the vacant spaces of the grid cells 14, and in a folded state of the stent 1, the blade outward-turning parts 217 can be embedded in the corresponding grid cells 14, the thickness of the stent 1 after being pressed and held cannot be increased, and the problem of abrasion between the stent 1 and the stent rod 421 does not exist, so that the larger connecting area and the strength are ensured, and meanwhile, when blood flows through the stent, the problem of thrombus caused by the retention of the blood due to the shape of a flow field is avoided; in addition, the design can provide better fluid dynamic performance.

Under the condition of ensuring the connection strength, the upper edges 214 of the second connecting part 215 and the first connecting part 218 are as small as possible, the smaller the upper edge 214 is, the smaller the shape jump after the sewing is, the better the fluid mechanical property is, and when blood flows through the connecting part, the blood stagnation is not formed due to the shape of the flow field, thereby causing the problem of thrombus. The outer edge 216 of the second connecting portion 215 is a blade bracket connecting edge, and the blade 20 is connected to the bracket 1 at the outer edge 216, that is, the outer edge 216 of the second connecting portion 215 is fixedly connected to the bracket rod 421 of the bracket 1, so that the shape of the outer edge 216 matches the shape of the bracket rod 421 fixedly connected thereto, and the outer edge 216 can be fixedly connected to a part of the bracket rod 421 of one grid unit 14, and can also be fixedly connected to the bracket rod 421 spanning multiple grid units 14, so that the second connecting portion 215 of some embodiments of the present invention covers a part of the area of one grid unit 14, and in other embodiments, the second connecting portion 215 covers multiple adjacent grid units 14 at the same time.

Preferably, the blade attachment portion 21 has three fold-over positions, namely a first fold-over position 211, a second fold-over position 212 and a third fold-over position 213. First folded position 211 is located at an interface of first connection portion 218 and blade body 24, and first connection portion 218 can be folded along first folded position 211; the second fold-over location 212 is located at the intersection of the first connection 218 and the second connection 215, the second connection 215 can be folded along the second fold-over location 212, the intersection of the blade outer-turned portion 217 and the second connection 215 is a third fold-over location 213, and the blade outer-turned portion 217 can be folded along the third fold-over location 213.

Taking the vane 20 of the structure shown in fig. 4, 5 and 6a as an example, when in use, three vanes 20 are folded and connected and fixed on the skirt 3 and the bracket 1, fig. 7 is a perspective view of the leaflet 2 formed by folding and connecting the three vanes 20 together through the vane connecting part 21, fig. 8a is a perspective view of the leaflet 2 at another view angle, and fig. 8b is an enlarged view of the area a in fig. 8 a. Specifically, the method comprises the following steps:

step S1: the first connection portion 218 and the second connection portion 215 are simultaneously turned downwards and outwards only along the first turning position 211, after turning, the first connection portion 218 is attached to the outer side of the blade main body 24, and the upper edge 214 is turned to the lower side of the free edge 23 of the blade; attaching the inner sides of two blades 20 to each other, and fixedly connecting the two adjacent blades 20 to the first connection portion 218 at the connection position, preferably by sewing; the inner side refers to the side of the adjacent two blades 20 which are contacted after being relatively attached, and the outer side refers to the other side of the blades 20 opposite to the inner side, so that the arrangement is to prevent endothelialization and untight closing caused by the foreign bodies clamped between the adjacent blades 20 when the adjacent blades 20 are closed.

Step S2: the second connecting portion 215 is folded outwards at a certain angle through the second folding position 212, at this time, the plane of the second connecting portion 215 is perpendicular to the plane of the first connecting portion 218 or forms an included angle smaller than 90 degrees, see the included angle α in fig. 8; securing the vanes 20 to the skirt 3 at a second connection 215, preferably by sewing; the blade 20 is fixed, preferably sewn, to a support bar 421 on the support 1 at the outer edge 216.

Step S3: finally, the blade outward-turned part 217 is turned to the outer side of the skirt 3 through the third turning position 213, at the moment, the skirt 3 is clamped between the blade outward-turned part 217 and the second connecting part 215, and the blade outward-turned part 217, the skirt 3 and the second connecting part 215 are fixedly connected, preferably connected by sewing.

The step sewing in the above steps S1-S3 may be replaced by integral sewing after the folding in steps S1-S3 is completed. The above steps are only one of the embodiments, and the method of folding the blade connecting portion 21 according to the present invention is not particularly limited, and may be adjusted according to the shape of the blade connecting portion 21 and the habit of the operator.

Fig. 6b and 6c show two other embodiments of the blade connecting portion 21, the second connecting portion 215b in fig. 6b provides a larger connecting area, so as to improve the connecting strength of the blade connecting portion 21 and the skirt 3, the outer edge 216b is also connected with the bracket bar 421, and compared with the shape of the second connecting portion 215a in fig. 5a, the second connecting portion 215b can cover more bracket bars 421, so as to improve the connecting strength of the blade connecting portion 21 and the bracket 1. In fig. 6a and 6b, the

blade eversion parts

217a and 217b are sewn with the skirt 3 after bypassing the outflow tract edge of the skirt 3, so as to ensure that the blade connecting part 21 cannot slide in the vertical direction, and the outflow tract of the skirt 3 corresponds to the part where the skirt 3 is sewn on the outflow tract 13 of the stent 1; the blade eversion portion 217c in fig. 6c is connected with the outflow tract vertex of the bracket 1, and the outflow tract vertex of the bracket 1 is wrapped by the third turnover position 213c and then is connected with the skirt 3 in a sewing way, so that the function of fixing the blade connecting portion 21 is achieved.

The skirt 3 is generally made of a polymer material, and the function of the skirt 3 includes: a. the valve is prevented from leaking around; b. as a medium for the fixation of the leaflets 2 to the stent 1, enhancing the stability of the leaflets 2; c. is beneficial to endothelialization of the heart valve prosthesis after implantation and improves the stability of the heart valve prosthesis. The skirt 3 may be of a one-piece structure or a multi-piece combined structure, and the shape may be adjusted as required, which is not particularly limited in the present invention. Fig. 9 shows an embodiment of the skirt, which shows a single skirt 30, connected by three identical skirts 30, covering the entire inner surface of the stent 1, the upper skirt edge 31 corresponding to the lower edge of the stent outflow tract 13 and the lower skirt edge 32 corresponding to the upper edge of the stent inflow tract 11. The skirt connection 33 refers to the connection between two adjacent skirts 30. The inner surface of the stent 1 is fixedly connected with the skirt 3 by sewing, bonding, welding and the like, preferably by sewing, and particularly, the skirt 3 is fixed on the stent 1 by a medical grade suture.

Preferably, the heart valve prosthesis provided by the embodiment includes a leaflet connecting portion 4, the leaflet connecting portion 4 includes a plurality of leaflet connecting pieces 41, the number of the leaflet connecting pieces 41 is the same as that of the leaflets 20, please refer to fig. 2, the leaflet 2 is disposed on the inner side of the stent 1, the leaflet connecting portions 21 on two adjacent leaflets 20 constituting the leaflet 2 are folded and then connected to the stent 1, the second connecting portions 215 are folded along the second folding positions 212 and then fixedly connected to the skirt 2 and the support rods 421, the blade outward-folded portions 217 are folded along the third folding positions 213 and then connected to the skirt and disposed in the gaps of the grid cells 14 formed by connecting the support rods 421, and one leaflet connecting piece 41 covers two adjacent second connecting portions 215 and covers the support rods 421 connected to the second connecting portions 215 and the support 1, is located outside the support 1, and plays a role in reinforcing and protecting the leaflets 2. The material of the leaflet linking piece 41 is not particularly limited, and may be a metal material, a polymer material, a biomaterial, or the like. The leaflet attachment pieces 41 cover the stent 1, the leaflets 2, and the skirt 3 at the same time, and the respective portions can be fixedly attached together by sewing or the like. If the connection mode of sewing is selected, the valve leaflet connecting sheet 41 can also play a role in protecting the sewing line and preventing the sewing line from being abraded by the bracket 1.

Fig. 10a and 10b are schematic structural views of the leaflet attachment piece 41, fig. 10a corresponding to the leaflet attachment portion 21 of fig. 6a and fig. 10b corresponding to the leaflet attachment portion 21 of fig. 6b, the leaflet attachment piece 41 including attachment piece

lower edges

412a and 412b and attachment piece sewn

portions

413a and 413 b. Wherein, the

lower edges

412a and 412b of the connecting sheets are respectively aligned with the

third folding positions

213a and 213b, the connecting

sheet sewing parts

413a and 413b are connected with the stent 1, the skirt 3, the second connecting

parts

215a and 215b and the blade outward-turning

parts

217a and 217b, preferably, the connecting sheet sewing parts are connected together by sewing, and the sewing thread is wrapped on the outer side of the leaflet connecting sheet 41 to prevent the sewing thread from being broken when the leaflet 2 forms a pulling force on the stent 1. When the blade outward-turned portion 217 of the blade connecting portion 21 is connected to the skirt 3 in the stent 1, the leaflet connecting piece 41 is located outside the connecting portion of the blade outward-turned portion 217 and the skirt 3. The leaflet attachment tabs 41 function as: a. if the leaflet tabs 41 are not present, the suture is in direct contact with the stent 1, and since the stent rod 421 is not circular in cross-section, the suture is easily worn by the edges of the stent 1. The leaflet tabs 41 may provide protection from the sutures coming into direct contact with the stent 1. b. Without the leaflet tabs 41, the sheath surrounding the valve can rub against the leaflet eversions 217 and, in the worst case, cause damage when the heart valve prosthesis is loaded into the delivery system, further affecting the leaflets 20. c. The leaflet attachment pieces 41 can increase the attachment strength between the leaflets 2, skirt 3 and stent 1. The leaflet attachment pieces 41 may be applied to leaflets 2 of other shapes, but the shape of the leaflet attachment pieces 41 changes as the shape of the leaflet attachment portion 21 changes. The method of adding the valve leaflet connecting sheet 41 increases the connecting strength and protects the blade connecting part 21. The shape of the leaflet attachment piece 41 is required to ensure that the second connection part 215 of the leaflet connection part 21 and the leaflet evagination part 217 are covered to prevent the leaflet connection part 21 from being damaged, and to cover the stent strut 421, which is connected to the stent 1, of the leaflet connection part 21 to prevent the suture line from being broken, at first.

Therefore, compared with the prior art, the invention has at least the following advantages:

1) the valve leaf structure of the heart valve prosthesis and the connection mode of the valve leaf and the support do not increase the support auxiliary structure, do not change the structure of the support, only through skillful design of the shape of the valve leaf, the connection part of the valve leaf is folded and connected with the support and the skirt edge, no adverse effect is caused to the heart valve prosthesis, and the damage of the valve leaf caused by stress concentration is avoided.

2) The heart valve prosthesis provided by the invention has the advantages that the adjacent two blades are connected together in a mode of folding the blade connecting part, the valve blades can be effectively closed, backflow cannot be generated, when the valve blades are opened, the connecting part of the adjacent blades does not have other hard structures except the valve blades, the skirt edges and the support, the effective opening area can be larger, and the heart valve prosthesis is provided with more excellent hydromechanical properties.

3) The heart valve prosthesis provided by the invention has the advantages that the leaflet connecting sheet is arranged to perform auxiliary connection on the leaflets, the support and the skirt, so that the connection strength of the connection parts of the adjacent leaflets of the leaflets is enhanced; secondly, the support rod is covered, so that the suture line is prevented from being broken by the support; and thirdly, the valve leaflets are prevented from being damaged when the heart valve prosthesis is sheathed.

Although the present invention has been described with respect to the preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. a heart valve prosthesis, comprising a support and a leaflet, the leaflet is arranged on the inner side of the support, the support comprises a grid unit formed by being connected by a support rod, it is characterized in that, the leaflet comprises At least two blades, the blades include a blade body and a blade connection part connected to the blade body, the blade connection part has a first connection part and a second connection part, the first connection part and the blade body A first folding position is formed at the junction of the first connecting part, a second folding position is formed at the junction of the first connecting part and the second connecting part, and the blade is folded along the first folding position The first connecting part is connected with the adjacent blade, and the blade is connected with the bracket through the second connecting part folded along the second folding position.

2 . The heart valve prosthesis of claim 1 , wherein, at the connection between the leaflet and the adjacent leaflet, the first connection portion is located outside the leaflet body, and the leaflet body The inner sides of the fuses are attached to each other and connected to the first connection part on the outer side thereof.

3 . The heart valve prosthesis according to claim 1 , wherein the second connecting portion has an outer edge, and the outer edge is fixedly connected to the stent rod of the stent. 4 .

4 . The heart valve prosthesis according to claim 1 , wherein the plane where the second connecting portion is folded along the second folded position is the same as the plane folded along the first folded position. 5 . The included angle of the plane where the first connecting portion is located is less than or equal to 90 degrees.

5. The heart valve prosthesis of claim 1, wherein the heart valve prosthesis comprises a skirt fixedly connected to the inner surface of the stent.

6 . The heart valve prosthesis according to claim 5 , wherein the leaflet connecting portion comprises a leaflet eversion portion, and a third leaflet is formed at the junction of the leaflet eversion portion and the second connecting portion. 7 . In the folding position, the blade is connected to the bracket and the skirt through the eversion portion of the blade folded along the third folding position.

7. The heart valve prosthesis of claim 6, wherein the leaflet everted portions are disposed within voids defined by the grid cells.

8. The heart valve prosthesis of claim 1, wherein the heart valve prosthesis comprises a plurality of leaflet connecting pieces, the leaflet connecting pieces covering the leaflet connecting portion and wrapping the leaflet connecting piece A stent rod where the part is connected to the stent, and the leaflet connecting piece is located on the outer side of the stent.

9. The heart valve prosthesis of claim 8, wherein the leaflet connecting piece comprises a connecting piece lower edge and a connecting piece suture, the connecting piece lower edge being aligned with the third folded position , the connecting piece stitching part is connected with the bracket rod and the second connecting part.

10 . The heart valve prosthesis according to claim 8 , wherein the leaflet has a leaflet free edge and a leaflet suture edge, and is sutured to the leaflet along the inner wall of the stent from the leaflet connecting piece Curved stitching with matching edges connects the blade to the bracket.

11. The heart valve prosthesis of claim 1, wherein the leaflet has a leaflet free edge and a leaflet suture edge, the number of the leaflet connecting portions of each leaflet is two, and the two leaflets The connecting portion is axially symmetrically arranged at the junction of the free edge of the blade and the stitched edge of the blade.