阅读说明：本技术 一种假体心脏瓣膜 (Prosthetic heart valve ) 是由 冒鹏志 阳明 赵春霞 陈国明 李�雨 于 2019-01-17 设计创作，主要内容包括：本发明公开了一种假体心脏瓣膜,其包括至少两个瓣膜构件、包覆于所述瓣膜构件上的密封件以及封边结构,包覆有所述密封件的所述瓣膜构件之间形成有空间间隙,所述封边结构的端面呈封闭状,且连接所述密封件的端部,以使所述空间间隙形成封闭空间。本发明提供的假体心脏瓣膜能够降低瓣膜构件间形成血栓的风险；由于封边结构具有柔性,因此,封边结构对假体瓣膜的压握基本无影响,同时封边结构的添加也不会影响假体瓣膜的正常功能。(The invention discloses a prosthetic heart valve which comprises at least two valve components, a sealing element and an edge sealing structure, wherein the sealing element is coated on the valve components, a space gap is formed between the valve components coated with the sealing element, the end surface of the edge sealing structure is in a closed shape and is connected with the end part of the sealing element, so that the space gap forms a closed space. The prosthetic heart valve provided by the invention can reduce the risk of thrombus formation between valve components; because the banding structure has the flexibility, consequently, the banding structure does not basically have the influence to the pressure of prosthetic valve is held, and the addition of banding structure can not influence the normal function of prosthetic valve yet simultaneously.)

1. The prosthetic heart valve is characterized by comprising at least two valve members, a sealing element and an edge sealing structure, wherein the sealing element covers the valve members, a space gap is formed between the valve members which are covered with the sealing element, the end face of the edge sealing structure is in a closed shape and is connected with the end part of the sealing element, and therefore the space gap forms a closed space.

2. The prosthetic heart valve of claim 1, wherein at least one of the valve members has a prosthetic leaflet disposed thereon.

3. The prosthetic heart valve of claim 1, wherein the seal is a skirt.

4. The prosthetic heart valve of claim 1, wherein the edge seal structure is a single layer edge seal configuration, a double layer edge seal configuration, or formed by a spaced connection of a double layer edge seal configuration to a single layer edge seal configuration.

5. The prosthetic heart valve of claim 4, wherein the single layer edge seal configuration is comprised of a skirt.

6. The prosthetic heart valve of claim 4, wherein the double seal configuration is comprised of a support structure and a skirt attached to the support structure.

7. The prosthetic heart valve of claim 6, wherein the support structure is a mesh structure formed by an end of one of the valve members extending toward an end of the other valve member, or by the two valve members extending toward each other.

8. The prosthetic heart valve of claim 6, wherein the support structure and the valve member are connected by riveting, welding, or sewing.

9. The prosthetic heart valve of claim 6, wherein the support structure and the valve member are integrally cut.

10. The prosthetic heart valve of any of claims 1-9, comprising a first valve member having an inflow and an outflow in an axial direction, and a second valve member having one end attached circumferentially outside the first valve member and the other end being a free end, the sealing structure connecting an end of the seal proximate the free end of the second valve member and an end of the seal on the inflow of the first valve member such that a spatial gap between the first valve member and the second valve member forms a closed space.

11. The prosthetic heart valve of claim 10, wherein an end face of the seal structure is horizontal or angled toward an outflow tract of the first valve member.

12. The prosthetic heart valve of claim 11, wherein an end of the seal proximate the free end of the second valve member is higher than an end of the seal on the inflow channel of the first valve member, and wherein an end face of the seal configuration is planar.

13. The prosthetic heart valve of claim 11, wherein an end of the seal proximate the free end of the first valve member is lower than or equal to a height of an end of the seal proximate the inflow channel of the first valve member, wherein an end surface of the seal is curved, wherein an end of the seal proximate the second valve member is upwardly convex in a curved surface, and wherein an end surface of the seal proximate the inflow channel of the first valve member is planar.

14. The prosthetic heart valve of claim 10, wherein a through structure is disposed between the first valve member and the second valve member, the through structure extending through an end surface of the sealing structure, and a contact between the sealing structure and the through structure is sealed.

15. The prosthetic heart valve of claim 10, wherein the first valve member is a stent body and the second valve member is a flange or an outer stent.

Technical Field

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

Background

Heart valves are membranous structures that can be opened and closed inside the organs of humans or some animals. Each individual has four valves in the heart, namely an aortic valve connecting the left ventricle and the aorta, a pulmonary valve connecting the right ventricle and the pulmonary artery, a mitral valve connecting the left atrium and the left ventricle, and a tricuspid valve connecting the right atrium and the right ventricle. They all act as one-way valves, allowing blood to flow only from one direction to the other, but not back.

With the development of socioeconomic and the increasing aging of population, senile valvular disease, coronary heart disease and valvular lesion caused by myocardial infarction are more and more common. Studies have shown that over 13.3% of elderly people over age 75 suffer from valvular heart disease to varying degrees. Heart valve disease has become one of the leading causes of health threats to humans.

For patients with advanced age, complicated multiple organ diseases, chest surgery history and poor cardiac function, the surgical operation risk is high, the mortality rate is high, and even part of patients lose the operation chance. The transcatheter valve implantation or repair has the advantages of no need of opening the chest, small wound, quick recovery of patients and the like. The native heart valves have different structures, and the valve prostheses need different anatomical structures and pathological requirements during interventional therapy, and accordingly, the structural designs of the prosthetic valves are different.

According to the number of layers of the valve stent, the existing prosthetic valve can be roughly divided into a single-layer valve and a multi-layer valve, and the multi-layer valve is formed by at least two layers of single-layer valves with different forms and different functions. Multilayer valves can be divided into two categories, local multilayer and global multilayer. Multilayer valves have incomparable advantages with single layer valves in terms of functions such as anchoring and sealing. However, research shows that due to different forms of the components of the multilayer valve, space gaps with different forms and sizes are often formed between different components. When the multi-layer prosthetic valve is implanted into the heart, blood is easily deposited in some space gaps to form thrombus, and especially the gaps among the scaffolds at the left atrium end are most common.

For example, in the case of a two-layered prosthetic valve, the outer prosthetic valve contacts the native heart tissue and is covered with a sealing member, such as a skirt, to seal the gap between the outer prosthetic valve and the native heart tissue, thereby preventing blood from flowing out of the gap; the inner layer prosthetic valve comprises prosthetic valve leaflets which play a role of a one-way valve, and the inner layer valve is also coated with sealing elements such as a skirt edge and the like, so that a unique channel for unidirectional flow of blood in the prosthetic valve is ensured. However, there are gaps in space between the skirt on the inner prosthetic valve and the skirt on the outer prosthetic valve where blood tends to pool, thereby forming a thrombus.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a prosthetic heart valve, which is used for sealing a gap between two adjacent valve members, wherein blood is easy to accumulate, so that thrombus is avoided.

The present invention provides a prosthetic heart valve, including at least two valve members, a sealing member covering the valve members, and a sealing structure, wherein a space gap is formed between the valve members covering the sealing member, and an end surface of the sealing structure is closed and connected to an end of the sealing member, so that the space gap forms a closed space.

Preferably, prosthetic valve leaflets are disposed on at least one of the valve members.

Preferably, the seal is a skirt.

Preferably, the edge sealing structure is a single-layer edge sealing structure, a double-layer edge sealing structure or a structure formed by connecting a double-layer edge sealing structure and a single-layer edge sealing structure at intervals.

Preferably, the single layer edge seal configuration is comprised of a skirt.

Preferably, the double-layer edge banding arrangement is comprised of a support structure and a skirt attached to the support structure.

Preferably, the support structure is a mesh structure formed by an end of one of the valve members extending towards an end of the other valve member, or by the two valve members extending towards each other.

Preferably, the support structure and the valve member are connected by riveting, welding or sewing.

Preferably, the support structure and the valve member are integrally cut.

Preferably, the prosthetic heart valve comprises a first valve member having an inflow channel and an outflow channel in an axial direction, and a second valve member having one end attached circumferentially outside the first valve member and the other end being a free end, the sealing structure connecting an end of the seal proximate the free end of the second valve member and an end of the seal on the inflow channel of the first valve member such that a spatial gap between the first valve member and the second valve member forms a closed space.

Preferably, the end surface of the sealing edge structure is horizontal or inclined towards the outflow tract of the first valve member.

Preferably, the end of the sealing element close to the free end of the second valve member is higher than the end of the sealing element on the inflow channel of the first valve member, and the end face of the sealing edge structure is a plane.

Preferably, the end of the sealing element close to the free end of the first valve member is lower than or equal to the height of the end of the sealing element on the inflow channel of the first valve member, the end face of the sealing edge structure is a curved surface, the end face of the sealing edge structure close to the second valve member protrudes upwards to form an arc surface, and the end face of the sealing edge structure close to the inflow channel of the first valve member is a flat surface.

Preferably, a penetrating structure is arranged between the first valve component and the second valve component, the penetrating structure penetrates through the end face of the edge sealing structure, and the contact position of the edge sealing structure and the penetrating structure is in a sealing state.

Preferably, the first valve member is a stent body and the second valve member is a flange or an outer stent.

Compared with the prior art, the invention has the following beneficial effects: according to the prosthetic heart valve provided by the invention, the sealing edge structure in the technical scheme is adopted on the two valve structures, so that a space gap between the sealing elements on the two valve members forms a closed space, and the risk of thrombus formation between different valve structures of the prosthetic heart valve can be greatly reduced; because the edge sealing structure has flexibility, the edge sealing structure basically has no influence on the pressure holding of the prosthetic valve, and the addition of the edge sealing structure can not influence the normal function of the prosthetic heart valve.

Drawings

Fig. 1 is a partial schematic structural view of a mitral prosthetic valve without a sealing edge structure according to an embodiment of the present invention, in which fig. 1(a) is a perspective view of the partial mitral prosthetic valve, and fig. 1(b) is a side view of the partial mitral prosthetic valve;

fig. 2(a) and 2(b) are schematic partial structural views of a mitral prosthetic valve having a sealing edge structure according to an embodiment of the present invention, where fig. 2(a) is a perspective view of the partial prosthetic heart valve and fig. 2(b) is a side view of the partial prosthetic heart valve;

fig. 3 is a schematic structural view of a mitral prosthetic valve according to a first embodiment of the present invention, in which fig. 3(a) is a mitral prosthetic valve without a sealing edge structure, and fig. 3(b), 3(c), and 3(d) are mitral prosthetic valves with a sealing edge structure;

fig. 4 is a schematic structural diagram of a mitral prosthetic valve according to a second embodiment of the present invention, in which fig. 4(a) is a mitral prosthetic valve without a sealing edge structure, and fig. 4(b), 4(c), and 4(d) are mitral prosthetic valves with a sealing edge structure;

fig. 5 is a schematic partial structure view of a mitral prosthetic valve according to a second embodiment of the present invention, in which fig. 5(a) is a schematic partial structure view of a mitral prosthetic valve without a sealing edge structure, and fig. 5(b), 5(c), 5(d), and 5(e) are schematic partial structure views of mitral prosthetic valves with sealing edge structures in different directions;

fig. 6 is a partial structural view of a mitral prosthetic valve according to a second embodiment of the present invention, in which fig. 6(a) is a partial structural view of a mitral prosthetic valve without a sealing edge structure, and fig. 6(b) and 6(c) are partial structural views of mitral prosthetic valves with sealing edges in different directions;

fig. 7 is a partial structural view of a mitral prosthetic valve according to a second embodiment of the present invention, in which fig. 7(a) is a partial structural view of a mitral prosthetic valve without a sealing edge structure, and fig. 7(b) and 7(c) are partial structural views of mitral prosthetic valves with sealing edges in different directions;

fig. 8 is a schematic structural view of a mitral prosthetic valve according to a third embodiment of the present invention, in which fig. 8(a) is a mitral prosthetic valve without a sealing structure, and fig. 8(b), 8(c), and 8(d) are mitral prosthetic valves with a sealing structure;

FIG. 9 is a schematic view of a mitral prosthetic valve according to a fourth embodiment of the present invention;

fig. 10 is a schematic view of a prosthetic heart valve according to an embodiment of the present invention placed in a delivery tube.

Note: for the convenience of observation, the prosthetic valves shown in fig. 3, 4 and 8 are all in the form of attached skirt edge images on the left side and bare stent images on the right side; except for the thin solid lines used for labeling, the other thin solid lines all represent support rods or metal rods; except for the thick solid lines used for labeling, the other thick solid lines all represent skirt edges; all thin dashed lines represent artificial leaflets; the thick solid lines in fig. 5, 6, 7, 9, and 10 all represent the edge banding structure.

In the figure:

110 flange 120 barb 130 stent main body 140 edge sealing structure 150 outer layer stent

160 special-shaped flange 170 hook 180 penetrates through structure 131, inflow channel 132 and outflow channel

1301 inflow channel end 1401 edge sealing structure end face

141 bearing structure 1601 dysmorphism flange free end

Detailed Description

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to one of ordinary skill in the art that the present invention may be practiced without these specific details. Accordingly, the particular details set forth are merely exemplary, and the particular details may be varied from the spirit and scope of the present invention and still be considered within the spirit and scope of the present invention.

Described herein are embodiments of prosthetic heart valves primarily intended for implantation in the mitral valve region of the human heart. Prosthetic valves may be used to help repair or replace the function of a defective native mitral valve. However, while the present invention focuses primarily on the mitral valve, the concepts are not limited to mitral valves and may be used on prosthetic valves for other regions or body parts of the heart, such as the tricuspid valve. The following takes mitral prosthetic heart valve as an example:

due to the anatomically large annulus size of the mitral valve, the portion of the support body of the prosthetic heart valve implanted in the mitral valve to carry the prosthetic valve leaflets needs to be larger in both circumferential diameter and axial height, resulting in a larger size of the prosthetic structure under the valve after the prosthetic valve is implanted in the mitral valve, with a greater risk of damage to the subvalvular structure of the native valve assembly. Meanwhile, the structure of the prosthesis under the valve is too large, so that the blood ejection function of the aorta is affected, and the left ventricular outflow tract is blocked. For some patients with mitral regurgitation, the calcified parts on the valve cannot adopt the existing working principle of preventing the displacement of the prosthetic valve by using the radial supporting force generated between the prosthetic valve and the native valve, so the treatment effect of the traditional single-layer mitral prosthetic valve is not ideal.

For the mitral valve prosthesis valve with a plurality of valve components, the valve components can distribute the functions of bearing the artificial valve leaflets, anchoring, sealing and the like to different valve components, thereby achieving the purposes of not influencing the normal operation of other structures of the heart and better playing the implantation treatment function. However, research shows that due to the different shapes of the valve components, space gaps with different shapes and sizes are formed between the sealing elements on the different valve components. When a prosthetic valve with a plurality of valve components is implanted into the heart, blood is easily accumulated in some space gaps to form thrombus, and especially the gaps among the valve components at the left atrium end are most common.

Therefore, referring to fig. 1, 2(a) and 2(b), the prosthetic heart valve provided in this embodiment includes at least two valve members, an outer prosthetic valve contacting with the native heart tissue, and a sealing member, such as a skirt, covering the surface of the outer prosthetic valve, and functioning to seal the gap between the outer prosthetic valve and the native heart tissue, so as to prevent blood from flowing out of the gap therebetween; the inner layer prosthetic valve comprises prosthetic valve leaflets which play a role of a one-way valve, and the inner layer valve is also coated with sealing elements such as a skirt edge and the like, so that a unique channel for unidirectional flow of blood in the prosthetic valve is ensured. The sealing elements in this embodiment are skirt edges, a space gap capable of causing blood stasis is formed between the skirt edges of the two valve members, the two valve members may be the stent main body 130 and the flange 110, or may be other valve members, the prosthetic heart valve is provided with the sealing edge structure 140, the end face 1401 of the sealing edge structure 140 is in a closed shape, the sealing edge structure 140 covers the end portions of the upper skirt edges of the two valve members, or the sealing edge structure 140 is connected with the end portions of the upper skirt edges of the two valve members, so that the sealing edge structure 140 can at least close the end face of the space gap formed between the upper skirt edges of the two valve members; that is, the open end facing the blood flow direction formed between the two valve members is closed, so that the space gap forms a closed space, and no matter in which direction the blood flows to the stent main body 130, the blood is not deposited and thrombus is formed.

The edge banding structure 140 may be a single layer edge banding structure, a double layer edge banding structure, or a combination of a double layer edge banding structure and a single layer edge banding structure. The single-layer sealing edge structure is formed by a skirt, and preferably, the skirt is tightly connected with the end parts of the upper skirts of the two valve components. The term "seal 140" as used herein, and in reference to the attachment of the ends of the upper seals of the valve members, or the like, encompasses the condition where the seal 140 covers the ends of the upper skirts of the two valve members.

The order of assembly of the edge seal 140 to the prosthetic heart valve stent can be two:

1. firstly, installing a skirt edge on a bare support, and then installing an edge sealing structure 140 on the support with the skirt edge;

2. the skirt and the sealing edge structure 140 are integrally mounted on the bare stent at the same time.

In one embodiment, the sealing edge structure 140 is formed by a skirt, as shown in fig. 3(d), 4(d) and 8(d), which is stretched to cover or connect the skirt ends of the two valve members, so that the space between the two valve members becomes a sealed space. The skirt is made of high molecular materials such as PET (polyethylene terephthalate) or PTFE (polytetrafluoroethylene) or animal pericardial biological tissues and covers the outer surface of the valve component needing to close the space gap to prevent the blood from leaking and achieve the sealing effect.

In another embodiment, the edge banding structure 140 is a double-layer edge banding structure formed by the support structure 141 and the skirt, as shown in fig. 3(b), 4(b), and 8 (b). The two valve components are connected by a rigid support structure 141, the connection position of the support structure 141 and the valve components is positioned at the end part of the skirt edge or a position above the end part of the skirt edge, the skirt edge is attached to the surface of the support structure 141, the skirt edge attached to the support structure 141 covers or is connected with the end part of the upper skirt edge of the valve components, and the support structure is a reticular structure formed by covering the support structure by a structure similar to a stent grid and sewing the skirt edge. Preferably, the support structure 141 is a mesh structure, and the support structure 141 is formed by extending an end of one of the two valve members toward an end of the other valve member, or by extending the two valve members toward each other.

The support structure 141 may be made of a shape memory metal, such as nitinol, cut into a mesh structure, and then formed by heat treatment. The support structure 141 may also be braided from a wire such as a nickel titanium wire. The supporting structure 141 may be made of nickel-titanium or other metal with special shape memory effect by cutting, heat treatment, shaping, and other processing techniques, and may be made of nickel-titanium wires or other metal wires. The lattice shape of the support structure 141 may be circular, diamond-shaped, or drop-shaped, and may or may not be the same as the lattice shape of the valve member.

The support structure 141 and valve member may be attached by riveting, welding, sewing, etc. When the support structure 141 and the valve member are both made of memory alloy, the support structure 141 and the valve member may be integrally cut, and then subjected to heat treatment, folding, shaping, and other processing techniques to form the final shape.

In yet another embodiment, the hem seal 140 is formed by spacing the support structure 141 to which the skirt is attached and the separate skirt, as shown in FIGS. 3(c), 4(c), and 8 (c). The edge sealing structure 140 is divided into 2 sections or a multi-section structure more than 2 sections, each section is manufactured by different processing modes, and finally, the edge sealing structure is mutually connected to form a complete edge sealing structure, for example: the edge sealing structure 140 is divided into three sections: the first section is formed by attaching a skirt edge after being woven by metal wires, the second section is formed by only attaching the skirt edge, the third section is integrally cut with the valve support and then attached with the skirt edge, and finally the three sections are connected in various suitable modes such as sewing, adhesion and the like to form the final edge sealing structure.

The sealing structure 140 is not limited to the type of prosthetic valve, and any space where blood may pool can be sealed by the sealing structure 140 to prevent thrombus. No matter what anchoring and sealing mechanism is adopted by the prosthetic valve stent, when a gap which is easy to accumulate blood exists, the prosthetic valve stent can be sealed by using edge sealing structures in different forms. I.e. different bracket designs may influence the design of the edge seal. The invention is further illustrated by the following examples. But are not limited to, the following several types and applications for prosthetic valves.