CN114681135A

CN114681135A - Heart valve prosthesis

Info

Publication number: CN114681135A
Application number: CN202011611922.8A
Authority: CN
Inventors: 邱尧; 顾晓杰; 刘世红; 冀丽军; 陈国明
Original assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Current assignee: Shanghai Microport Cardioflow Medtech Co Ltd
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2022-07-01

Abstract

The invention provides a heart valve prosthesis, which is applied to the technical field of interventional medical prostheses. In the heart valve prosthesis provided by the invention, under the condition that the sizes of the valve leaflet connecting parts are the same, compared with the condition that the closed holes are arranged on the valve leaflet fixing structure in the prior art, the valve leaflet connecting parts of the double-row hole structure with the structure that each row of holes at least comprises one non-closed hole are arranged in the support main body in the heart valve prosthesis, so that more suture holes which are more compactly distributed can be arranged on the valve leaflet fixing structure, the connecting points of the valve leaflets and the support are increased, the connecting strength of the valve leaflets and the support is enhanced under the condition that the outer diameter of the support is not increased after the support is compressed, and the stability of the heart valve prosthesis in a working state is further improved.

Description

Heart valve prosthesis

Technical Field

The invention relates to the technical field of interventional medical prostheses, in particular to a heart valve prosthesis.

Background

The heart contains four chambers, the left atrium and left ventricle being located on the left side of the heart, and the right atrium and right ventricle being located on the right side of the heart. A ventricular inflow channel structure is formed between the atria and the ventricles, a left ventricular outflow channel structure is formed between the left ventricle and the aorta, and a right ventricular outflow channel structure is formed between the right ventricle and the pulmonary artery. Valves with the function of 'one-way valves' exist at the ventricular inflow canal structure and the ventricular outflow canal structure, and normal flow of blood in the heart cavity is guaranteed. When a problem occurs with the valve, the hemodynamics of the heart change and the heart functions abnormally, which is called valvular heart disease.

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. Prosthetic Heart valves (Heart Valve prostheses) are artificial organs that can be implanted in the Heart to replace Heart valves (including aortic, pulmonary, tricuspid and mitral valves), allow unidirectional blood flow, and function as native Heart valves. Prosthetic heart valve replacement is necessary when the heart valve is so diseased that a valve separation or repair procedure cannot be used to restore or improve valve function. The design of interventional heart valves is difficult due to the complexity of their replacement. For example, in practical applications, prosthetic heart valves have certain requirements on the contact area of the valve leaflets after closure and the stability of the connection of the leaflets to the stent.

However, in the prior art, the mechanical property of the stent of the artificial heart valve for interventional operation is relatively poor, which affects the connection between the valve leaflet and the stent and causes the defect of poor connection stability between the valve leaflet and the stent, so that the valve displacement is easy to occur under the impact action of blood in the normal operation process of the lesion position of the artificial heart valve in the human body, and thus, when the heart valve is in a closed state, the contact area of the valve leaflet is insufficient, and the failure of the artificial heart valve prosthesis is caused under the serious condition. Further, for a transcatheter heart valve system, the valve stent is compressed into a sheath of a delivery system, and the delivery of the valve stent is achieved by axial movement of the sheath, so that the compressed outer diameter (profile) of the valve stent needs to be slightly smaller than the inner diameter of the sheath. And if the number of the connecting holes of the valve leaflet and the support in the prior art is increased, the outer diameter (profile) of the valve support after being compressed is increased. Therefore, how to enhance the connection strength between the leaflet and the stent without increasing the outer diameter (profile) of the valve stent after compression is a problem to be solved.

Disclosure of Invention

The invention aims to provide a heart valve prosthesis, which can be used for enhancing the connection strength between a valve leaflet and a support in the heart valve prosthesis under the condition that the outer diameter of the support in the heart valve prosthesis is not increased after compression.

In order to solve the technical problems, the invention provides a heart valve prosthesis, which comprises a stent main body and at least two valve leaflets connected to the stent main body, wherein the stent main body comprises grid-shaped structural units connected with each other from an inflow end to an outflow end, the stent main body further comprises a plurality of valve leaflet fixing structures, and each valve leaflet fixing structure comprises a support part and valve leaflet connecting parts positioned on two sides of the support part; the leaflet connecting component comprises a double-row hole structure, wherein each row of holes in the double-row hole structure at least comprises one non-closed hole.

Alternatively, the leaflet securing structure may be provided at the outflow end of the stent body, or on the outer surface along the circumference of the stent body.

Alternatively, a plurality of the leaflet connecting members may be uniformly arranged in the circumferential direction of the cross section of the stent body.

Optionally, when each row of holes in the double-row hole structure includes a plurality of non-closed holes, two rows of holes in the double-row hole structure may be symmetrically disposed along the central axis of the support member.

Optionally, the aperture size of each hole in the double-row hole structure in the axial direction is adapted to the contact height required by two adjacent valve leaflets in the axial direction, and/or the number of each row of holes in the double-row hole structure is adapted to the contact height required by two adjacent valve leaflets in the axial direction.

Optionally, the aperture of each hole in the double-row hole structure in the axial direction may range from 0.6mm to 2 mm.

Optionally, the number of each row of holes in the double-row hole structure may be 1-4.

Optionally, the number of leaflet securing structures is the same as the number of leaflets.

Optionally, when the leaflet fixing structure is disposed at the outflow end of the stent body, the leaflet fixing structure is inclined toward the axial direction of the stent body so that the leaflet fixing structure forms a predetermined angle with the central axis of the stent body.

Optionally, a value range of a preset angle formed by the leaflet fixing structure and the central axis of the stent main body is 0 to 15 °.

Alternatively, the coaptation region of two adjacent leaflets can be sutured to the leaflet connecting member to connect the leaflets to the stent body.

Optionally, when each of the holes of the leaflet-connecting member is a non-closed hole penetrating the leaflet-connecting member and having a notch at one side, a suture for suturing the bonding area of the adjacent two leaflets to the leaflet-connecting member is embedded in the notch of the leaflet-connecting member.

Compared with the prior art, the technical scheme of the invention has at least one of the following beneficial effects:

in the heart valve prosthesis provided by the invention, under the condition that the sizes of the valve leaflet connecting parts are the same, compared with the condition that the closed holes are arranged on the valve leaflet fixing structure in the prior art, the valve leaflet connecting parts of the double-row hole structure with the structure that each row of holes at least comprises one non-closed hole are arranged in the support main body in the heart valve prosthesis, so that more suture holes which are more compactly distributed can be arranged on the valve leaflet fixing structure, the connecting points of the valve leaflets and the support are increased, the connecting strength of the valve leaflets and the support is enhanced under the condition that the outer diameter of the support is not increased after the support is compressed, and the stability of the heart valve prosthesis in a working state is further improved.

Drawings

FIG. 1 is a schematic structural view of a heart valve prosthesis according to an embodiment of the present invention;

FIG. 2 is a front view of the corresponding heart valve prosthesis of FIG. 1;

FIG. 3 is a schematic diagram of the structure of valve leaflets in a heart valve stent according to an embodiment of the invention;

FIG. 4 is a schematic structural view of a heart valve stent according to an embodiment of the present invention;

fig. 5 is an enlarged schematic view of a leaflet securing structure in a heart valve stent according to an embodiment of the invention.

Wherein the reference numbers are as follows:

1-a heart valve stent; 2-skirt edge;

3-valve leaflets; 4-a binding region;

5-leaflet upper edge; 6-leaflet lower edge;

7-a suture; 11-inflow end;

12-the outflow end; 13-a leaflet securing structure;

131-leaflet connecting member; 132-support member.

Detailed Description

A heart valve prosthesis of the present invention will be described in further detail below. The present invention will now be described in more detail with reference to the accompanying drawings, in which preferred embodiments of the invention are shown, it being understood that one skilled in the art may modify the invention herein described while still achieving the advantageous effects of the invention. Accordingly, the following description should be construed as broadly as possible to those skilled in the art and not as limiting the invention.

In the interest of clarity, not all features of an actual implementation are described. In the following description, well-known functions are not described in detail, as they would obscure the invention in unnecessary detail. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific details must be set forth in order to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art.

Bearing as background art said, because in prior art, the mechanical properties of the artificial heart valve support of intervention operation is relatively poor, this can influence the connection of leaflet and support, cause the defect of the poor stability of being connected of leaflet and support, and then make artificial heart valve in the normal operating process of human internal pathological change position, easy emergence support deformation under the impact of blood, especially, lead to heart valve when closed state when leaflet and support combination department take place deformation, valve leaflet area of contact is not enough, cause the problem of artificial heart valve prosthesis inefficacy under the severe condition. Further, for a transcatheter heart valve system, the valve stent is compressed into a sheath of a delivery system, and the delivery of the valve stent is achieved by axial movement of the sheath, so that the compressed outer diameter (profile) of the valve stent needs to be slightly smaller than the inner diameter of the sheath. And if the number of the connecting holes of the valve leaflet and the support in the prior art is increased, the outer diameter (profile) of the valve support after being compressed is increased.

To this end, the present invention provides a heart valve prosthesis to enhance the coupling strength between leaflets and a stent in the heart valve prosthesis without an increase in outer diameter of the stent after compression in the heart valve prosthesis.

In practical applications, the side of the blood flowing into the prosthetic heart valve prosthesis is generally referred to as the inflow end of the heart valve stent, and the side of the blood flowing out of the prosthetic heart valve prosthesis is generally referred to as the outflow end of the heart valve stent, according to the flowing direction of the blood in the prosthetic heart valve prosthesis. It is understood that the inflow end and the outflow end are only used for identifying the flow direction of blood, and the specific position of each part in the prosthetic heart valve prosthesis is not particularly limited.

The axial direction refers to the direction of the rotation center of the cylinder-like object, which is the common direction with the central shaft, and in the embodiment of the present invention, the axial direction of the stent main body refers to the direction extending along the two ends of the inflow end and the outflow end of the stent main body.

The heart valve prosthesis provided by the invention is further described in the following with reference to the drawings and the embodiments.

Referring to fig. 1 and fig. 2, fig. 1 is a schematic structural diagram of a heart valve prosthesis according to an embodiment of the present invention, and fig. 2 is a front view of the heart valve prosthesis shown in fig. 1.

As shown in fig. 1 and 2, the heart valve prosthesis comprises a heart valve support 1, a skirt 2 and a heart valve, wherein the heart valve comprises at least two valve leaflets 3.

In this embodiment, the heart valve stent 1 is used to carry a prosthetic heart valve, which may typically comprise a plurality of leaflets 3 in order to match the actual condition of a human heart valve. In an embodiment of the present invention, as shown in fig. 3, each leaflet 3 may specifically include a leaflet lower edge 6 (for connecting the leaflet 3 with the skirt 2), a leaflet upper edge 5, and a joining region 4 (for fixing two adjacent leaflets 3). Among them, the coaptation region of adjacent leaflets 3 in a prosthetic heart valve can be referred to as the coaptation region 4 (comissure) of adjacent leaflets 3; also, the leaflets 3 may be attached to the stent 1 by the commissure regions 4, for example, by folding or wrapping the stent and then suturing the stent.

Referring to fig. 4, fig. 4 is a schematic structural view of the heart valve stent 1 shown in fig. 1 and 2. As shown in fig. 4, the heart valve stent includes a stent body including interconnected lattice-like structural units from an inflow end 11 to an outflow end 12. And, the stent main body further includes a plurality of leaflet fixing structures 13 for connecting the stent main body with the leaflets 3.

The stent main body can be made of shape memory alloy, and preferably, the stent main body is made of nickel titanium metal material.

In this embodiment, the inlet of the large-mouth end surface of the upper half of the lattice structure in fig. 4 is referred to as the inlet end 11 of the stent body, and the outlet of the small-mouth end surface of the lower half of the lattice structure is referred to as the outlet end 12 of the stent body. Illustratively, each of the leaflet securing structures 13 may be disposed at the outflow end 12 of the stent body such that the plurality of leaflet securing structures 13 are connected to the lattice structure, as shown in fig. 4. Preferably, the leaflet fixing structure 13 is inclined toward the axial direction of the stent body such that the leaflet fixing structure 13 forms a predetermined angle with the central axis of the stent body. The valve leaf fixing structure 13 and the central axis of the stent main body form a preset angle, and the value range of the preset angle is preferably 0-15 degrees. The valve leaflet fixing structure 13 can be better matched with the shape of the corresponding heart native tissue after being implanted, and the influence on the heart native tissue is reduced.

In the embodiment of the present invention, the leaflet fixing structure 13 is inclined toward the axial direction of the stent main body, so that on one hand, damage to native tissues of a heart portion of a human body can be avoided, and on the other hand, the leaflet fixing structure can be more adapted to the shape of the closed valve leaflets, so as to prolong the service life of the heart valve prosthesis.

Optionally, each leaflet fixing structure 13 may be further disposed on an outer surface along a circumferential direction of the stent body, that is, on an outer surface of a certain stent body between the inflow end and the outflow end of the stent body, so that the leaflet fixing structures 13 are matched with the shape of the valve leaflets, thereby reducing stress concentration, prolonging the service life of the suture, and finally prolonging the service life of the valve prosthesis. The leaflet securing structure 13 is preferably integrally formed with the stent body by laser cutting.

For clarity of description, the structure of the leaflet fixing structure 13 will be specifically described below by way of the following examples.

Referring to fig. 5, fig. 5 is an enlarged schematic structural view of a leaflet fixing structure 13 according to an embodiment of the invention. As shown in fig. 5, the leaflet fixing structure 13 includes a support member 132 and leaflet connecting members 131 located on both sides of the support member 132. Wherein the leaflet connecting member 131 comprises a double row hole structure, and each row of holes of the double row hole structure may include at least one non-closed hole. Each row of holes of the leaflet connecting member 131 is aligned in the axial direction of the support member 132. Wherein the axial direction is a direction extending along both ends of the support part 132 of the leaflet fixing structure 13.

It is to be understood that the non-closed hole in the embodiment of the present invention refers to a through hole having a notch on a side of a side wall, and the notch opens toward a side of the leaflet-connecting member remote from the support member.

In this embodiment, each of the holes of the leaflet attachment member 131 is a non-closed hole that penetrates through the leaflet attachment member 131, and the indentations of the two rows of holes are disposed opposite to each other and open the edge of the leaflet attachment member 131. Under the condition that the size of the leaflet connecting component is the same, compared with the condition that the closed hole is arranged on the leaflet fixing structure in the prior art, the method for connecting the leaflet with the stent has the advantages that the non-closed hole arranged on the leaflet fixing structure 13 can realize the arrangement of suture holes with more quantity and more compact distribution, so that the connecting points of the leaflet and the stent are increased, and the connecting strength of the leaflet and the stent is enhanced under the condition that the profile of the stent is not increased. Subject to the state of the art, the minimum size of a closed aperture can only be D1, whereas if a non-closed aperture is provided, the minimum size of the non-closed aperture can be much smaller than D1, thus allowing a greater number and more compact distribution of non-closed apertures to be provided on a leaflet-holding structure of the same size.

Optionally, a plurality of the leaflet connecting members 131 are circumferentially uniformly or circumferentially non-uniformly disposed along the cross-section of the stent body. For example, when there are 3 leaflet connecting members 131, an included angle between a line connecting every two adjacent leaflet connecting members 131 to a central axis of the stent body is 120 °, and it can be understood that 3 leaflet connecting members 131 are uniformly arranged in a circumferential direction of a cross section of the stent body; to match a particular cross-sectional shape of some stents, such as the D-shaped cross-section of a mitral valve stent, the included angle between the connecting lines of two adjacent leaflet connecting members 131 to the central axis of the stent body may also be set to 160 °, 100 °, in which case it is understood that 3 of the leaflet connecting members 131 are non-uniformly arranged along the circumference of the cross-section of the stent body.

Further, when each row of holes of the dual-row hole structure of the leaflet connecting member 131 includes a plurality of non-closed holes, two rows of holes of the dual-row hole structure may be symmetrically disposed along the central axis of the support member 132.

Further, the aperture size of each hole in the double-row hole structure in the axial direction is matched with the contact height required by two adjacent valve leaflets in the axial direction, and/or the number of each row of holes in the double-row hole structure is matched with the contact height required by two adjacent valve leaflets in the axial direction. Specifically, the size of the hole diameter of each hole in the axial direction, the number of holes in each row, and the axial distance between adjacent holes together determine the required contact height of two adjacent leaflets in the axial direction.

Preferably, the aperture of each hole in the double-row hole structure in the axial direction may range from 0.6mm to 5mm, and the number of each row of holes in the double-row hole structure may range from 1 to 4. Furthermore, the whole height of the double-row hole structure along the axial direction can be in a range of 2.5-5 mm.

In this embodiment, because the number of each row of holes in the double-row hole structure and the size of each hole in the axial direction can be designed to different numbers and sizes according to different actual requirements, the contact height of two adjacent valve leaflets in the heart valve prosthesis in the axial direction can be properly adjusted (usually, the contact height is extended) according to the actual requirements, and the problem of high difficulty in closing the valve leaflets is solved. In addition, the non-closed double-row hole structure of the leaflet connecting part 141 can further reduce the volume of each leaflet connecting part, thereby being beneficial to reducing the radial diameter of the heart valve prosthesis after being crimped, and being more suitable for the engineering design of the stent.

Optionally, with continued reference to fig. 4, and with reference to fig. 3 and 1, the joining region 4 of two adjacent leaflets 3 is sewn to the leaflet attachment structure 131 so that the heart valve is fixedly disposed on the inner surface of the stent body.

In this embodiment, the joining region 4 of the adjacent valve leaflet 3 is sewn to the leaflet connecting portion 131 of the stent body, thereby achieving stable fixation of the adjacent two valve leaflets. Therefore, it is preferable that the number of the leaflet fixing structures 13 is the same as the number of leaflets included in the heart valve disposed on the stent body. And, the central axis of each leaflet securing structure 13 coincides with or is parallel to the axis of the coaptation region 4 between adjacent leaflets.

Alternatively, when each hole of the leaflet-connecting member 131 is a non-closed hole penetrating the leaflet-connecting member 131 and having a notch at one side, a suture thread for suturing the bonding area of the adjacent two leaflets 3 to the leaflet-connecting member 131 is inlaid in the notch of the leaflet-connecting structure 131.

In summary, in the heart valve prosthesis provided by the present invention, under the condition that the size of the leaflet connecting component is the same, compared with the closed hole arranged on the leaflet fixing structure in the prior art, the embodiment of the present invention arranges the leaflet connecting components of the double-row hole structure in which each row of holes at least includes one non-closed hole in the stent main body in the heart valve prosthesis, so that a larger number of suture holes with more compact distribution can be arranged on the leaflet fixing structure, the connecting points of the leaflets and the stent are increased, the connecting strength between the leaflets and the stent is enhanced without increasing the outer diameter of the stent after compression, and the stability of the heart valve prosthesis in the working state is further improved.

It should be noted that, although the present invention has been described with reference to the preferred embodiments, the present invention is not limited to the embodiments. It will be apparent to those skilled in the art from this disclosure that many changes and modifications can be made, or equivalents modified, in the embodiments of the invention without departing from the scope of the invention. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention will still fall within the protection scope of the technical solution of the present invention.

It should be further understood that the terms "first," "second," "third," and the like in the description are used for distinguishing between various components, elements, steps, and the like, and are not intended to imply a logical or sequential relationship between various components, elements, steps, or the like, unless otherwise indicated or indicated.

It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention. It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a step" or "an apparatus" means a reference to one or more steps or apparatuses and may include sub-steps as well as sub-apparatuses. All conjunctions used should be understood in the broadest sense. And, the word "or" should be understood to have the definition of a logical "or" rather than the definition of a logical "exclusive or" unless the context clearly dictates otherwise. Further, implementation of the methods and/or apparatus of embodiments of the present invention may include performing the selected task manually, automatically, or in combination.

Claims

1. A heart valve prosthesis comprises a support main body and at least two valve leaflets connected to the support main body, wherein the support main body comprises grid-shaped structural units connected with each other from an inflow end to an outflow end, the heart valve prosthesis is characterized in that the support main body further comprises a plurality of valve leaflet fixing structures used for connecting the support main body and the valve leaflets, each valve leaflet fixing structure comprises a support component and a valve leaflet connecting component positioned on two sides of the support component, each valve leaflet connecting component comprises a double-row hole structure, and each row of holes in the double-row hole structure at least comprise one non-closed hole.

2. The heart valve prosthesis of claim 1, wherein the leaflet securing structure is disposed at an outflow end of the stent body or on an outer surface along a circumference of the stent body.

3. The heart valve prosthesis of claim 1, wherein the leaflet attachment members are uniformly circumferentially disposed along a cross-section of the stent body.

4. The heart valve prosthesis of claim 1, wherein when each row of holes in the double row of holes structure comprises a plurality of non-closed holes, the two rows of holes in the double row of holes structure are symmetrically disposed along the central axis of the support member.

5. The heart valve prosthesis of claim 1, wherein each aperture in the dual-row aperture structure has a size in the axial direction that is compatible with a desired contact height in the axial direction for two adjacent leaflets, and/or wherein each row of apertures in the dual-row aperture structure has a number that is compatible with a desired contact height in the axial direction for two adjacent leaflets.

6. The heart valve prosthesis of claim 5, wherein the pore diameter of each pore in the double row of pores structure in the axial direction ranges from 0.6mm to 2 mm.

7. The heart valve prosthesis of claim 5, wherein the number of holes in each row of the double row of holes structure is 1-4.

8. The heart valve prosthesis of claim 1, wherein the number of leaflet securing structures is the same as the number of leaflets.

9. The heart valve prosthesis of claim 2, wherein the leaflet securing structure is angled toward an axial direction of the stent body such that the leaflet securing structure forms a predetermined angle with a central axis of the stent body when the leaflet securing structure is disposed at the outflow end of the stent body.

10. The heart valve prosthesis of claim 9, wherein the predetermined angle is in a range of 0 ° to 15 °.

11. The heart valve prosthesis of any one of claims 1-10, wherein the bonding regions of adjacent leaflets of the leaflet are sewn to the leaflet connecting member to connect the leaflet to the stent body.

12. The heart valve prosthesis of claim 11, wherein when each of the holes of the leaflet-connecting member is a non-closed hole penetrating the leaflet-connecting member and having a notch at one side, a suture for suturing the bonding region of the adjacent two leaflets to the leaflet-connecting member is fitted in the notch of the leaflet-connecting member.