CN113081394B

CN113081394B - Artificial heart valve

Info

Publication number: CN113081394B
Application number: CN202110389627.0A
Authority: CN
Inventors: 刘浩; 葛晨耀; 龚霄雁
Original assignee: Suzhou Innomed Medical Device Co ltd
Current assignee: Suzhou Innomed Medical Device Co ltd
Priority date: 2021-04-12
Filing date: 2021-04-12
Publication date: 2022-08-05
Anticipated expiration: 2041-04-12
Also published as: WO2022218445A1; CN113081394A

Abstract

The invention relates to the technical field of medical equipment, in particular to a prosthetic heart valve, which comprises: the outer support comprises an upper lip section, a transition section and a lower lip section, the cross section of the upper part of the upper lip section is circular or D-shaped, the lower part of the upper lip section is bent inwards, the lower lip section is in a horn mouth shape, and the transition section is connected between the upper lip section and the lower lip section; the inner support is arranged in the outer support and comprises an inflow section and an outflow section, the inflow section is in a bamboo hat shape, and the outflow section is in a cylindrical shape; and the artificial valve leaf is arranged inside the outflow section. According to the invention, the outer support is arranged to be of a clip-shaped structure as a whole, so that the artificial valve leaflet can be opened and closed better, and the service life of the artificial valve leaflet is prolonged; through setting up the inner support to including inflow section and outflow section to through setting up the inflow section into bamboo hat form, can reduce the load stress on the artificial valve leaf, through setting up the outflow section into cylindricly, can be used for replacing artificial valve leaf under the condition that artificial valve leaf damaged.

Description

Artificial heart valve

Technical Field

The invention relates to the technical field of medical instruments, in particular to a prosthetic heart valve.

Background

The heart has four valves, the valve between the left atrium and the left ventricle is the mitral valve, the valve between the right atrium and the right ventricle is the tricuspid valve, the valve between the aorta and the left ventricle is the aortic valve, and the valve between the pulmonary artery and the right ventricle is the pulmonary valve. A normal valve can maintain one-way flow of blood by opening and closing according to the pressure difference on each side, ensuring that the blood in the chamber is pumped out without backflow.

Taking the mitral valve as an example, the mitral valve acts as a check valve to tightly close the atrioventricular orifice and prevent blood from flowing back from the left ventricle into the left atrium when the left ventricle contracts. However, when the mitral valve is diseased, it may happen that the left ventricle is difficult to close completely when contracting, resulting in the left atrium receiving a large amount of blood backflow, which may result in a sharp rise in left atrium and pulmonary venous pressure, an increase in left ventricle diastolic volume load, and further a series of pathological changes such as left ventricle enlargement and pulmonary hypertension, and finally clinical manifestations such as heart failure, arrhythmia, etc., which may endanger life in severe cases.

In recent years, with the progress of interventional therapy technology, transcatheter (or transapical) mitral valve repair and transcatheter (or transapical) mitral valve replacement are rapidly developed and applied clinically, and more satisfactory effects are achieved. Prosthetic heart valves are implanted into the in situ mitral valve by minimally invasive intervention procedures to replace or repair the damaged native valve for related work. The artificial heart valve mainly comprises a support and an artificial valve leaflet positioned in the support, and the current artificial heart valve has the technical problem that the artificial valve leaflet cannot work in an optimal state due to unreasonable support structure design.

Disclosure of Invention

The invention aims to provide a prosthetic heart valve, which aims to solve the technical problem that the prosthetic valve leaflet cannot work in an optimal state due to unreasonable design of a support structure in the prior art.

In order to achieve the purpose, the invention adopts the following technical scheme:

a prosthetic heart valve, comprising:

the outer support comprises an upper lip section, a transition section and a lower lip section, the cross section of the upper part of the upper lip section is circular or D-shaped, the lower part of the upper lip section is bent inwards, the lower lip section is in a horn mouth shape, and the transition section is connected between the upper lip section and the lower lip section;

the inner support is arranged inside the outer support and comprises an inflow section and an outflow section, the inflow section is in a bamboo hat shape, the outflow section is in a cylindrical shape, the upper end of the inflow section is connected with the upper lip section, the lower end of the inflow section is connected with the upper end of the outflow section, and the lower end of the outflow section extends downwards to the outside of the lower lip section;

a prosthetic valve leaflet disposed inside the outflow section of the inner stent;

and the coating comprises an inner coating and an outer coating, the inner coating is coated on the inner wall of the inflow section of the inner stent, and the outer coating is coated on the inner wall of the transition section of the outer stent.

As a preferred technical scheme of the artificial heart valve, the transition section is in a curve section contour.

As a preferable technical scheme of the artificial heart valve, the material of the inner covering film and the outer covering film is one or the combination of more of TPU, PET, e-PTFE and PTFE.

As a preferable technical scheme of the artificial heart valve, the thickness of the inner covering film and the outer covering film is 0.01-1 mm.

As a preferable technical scheme of the artificial heart valve, the artificial valve leaflet is connected with the inner covering film in a sewing mode.

As a preferable technical scheme of the artificial heart valve, the material of the artificial valve leaflet is flexible polymer or biological tissue.

As the optimal technical scheme of the artificial heart valve, the inner support and the outer support are integrally woven by shape memory elastic materials.

As a preferable technical scheme of the artificial heart valve, the inner support and the outer support are both made of metal mesh structures, and the inner support and the outer support are connected through welding.

As a preferred technical scheme of the artificial heart valve, a plurality of first welding terminals are arranged on the inner support, a plurality of second welding terminals which correspond to the first welding terminals one to one are arranged on the outer support, and the first welding terminals and the second welding terminals are fixedly connected through welding.

As a preferred technical solution of the artificial heart valve, a connecting pipe is sleeved outside the first welding terminal and the second welding terminal, and the connecting pipe is made of metal with developing property.

The invention has the beneficial effects that:

the invention provides a heart valve prosthesis, which can clamp an outer support at a native valve ring and a native valve leaflet by arranging the outer support into a whole clip-shaped structure, provide positioning and anchoring for the inner support, reduce or even eliminate the influence of radial repeated movement of the outer support on the inner support in the heartbeat cycle, and prevent the deformation of the inner support from being overlarge in the heartbeat cycle, thereby enabling the artificial valve leaflet to be better opened and closed and being beneficial to prolonging the service life of the artificial valve leaflet; in addition, the inner support is arranged to comprise the inflow section and the outflow section, the inflow section is arranged to be in a bamboo hat shape, the shock absorption effect can be achieved in the heart beat circulation, the load stress on the artificial valve leaflet is reduced, the load of the outer support in anchoring is reduced, the outflow section is arranged to be in a cylindrical shape, the anchoring carrier of the artificial valve leaflet can be used, the outflow section can be properly expanded by using a saccule under the condition that the artificial valve leaflet is damaged and is used for replacing the artificial valve leaflet (valve-in-valve structure), and the structural positioning and anchoring effect on the outer support after the valve is replaced by expanding the inner support is small due to the fact that the inner support is suspended in the outer support.

Drawings

Fig. 1 is a schematic perspective view of a prosthetic heart valve according to an embodiment of the present invention;

FIG. 2 is a front cross-sectional view of a prosthetic heart valve provided in accordance with an embodiment of the present invention;

fig. 3 is a front sectional view of an inner stent and an outer stent according to an embodiment of the present invention;

fig. 4 is a schematic diagram illustrating the formation of an inner stent and an outer stent according to an embodiment of the present invention;

FIG. 5 is a schematic structural diagram of an outer coating film according to an embodiment of the present invention;

FIG. 6 is a schematic structural diagram of an inner coating according to an embodiment of the present invention;

fig. 7 is a schematic structural view of an artificial leaflet according to an embodiment of the present invention;

FIG. 8 is a schematic view of a prosthetic heart valve implanted in a heart chamber according to an embodiment of the present invention;

fig. 9 is a schematic perspective view of a prosthetic heart valve according to a second embodiment of the present invention;

fig. 10 is a front cross-sectional view of a prosthetic heart valve provided in accordance with a second embodiment of the present invention.

In the figure:

1. an outer support; 11. an upper lip segment; 12. a transition section; 13. a lower lip section; 2. an inner support; 21. an inflow section; 22. an outflow section; 3. artificial valve leaflets; 31. sewing the edges; 32. a free edge; 41. internally laminating a film; 42. coating a film outside; 5. a connecting pipe; 6. a heart; 61. native valve leaflets.

Detailed Description

The technical scheme of the invention is further explained by combining the attached drawings and the embodiment. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not to be construed as limiting the invention. It should be further noted that, for the convenience of description, only some but not all of the elements associated with the present invention are shown in the drawings.

In the description of the present invention, unless expressly stated or limited otherwise, the terms "connected," "connected," and "fixed" are to be construed broadly, e.g., as meaning permanently connected, removably connected, or integral to one another; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the present invention, unless otherwise expressly stated or limited, "above" or "below" a first feature means that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact with each other via another feature therebetween. Also, the first feature being "on," "above" and "over" the second feature includes the first feature being directly on and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature.

In the description of the present embodiment, the terms "upper", "lower", "left", "right", and the like are used based on the orientations and positional relationships shown in the drawings only for convenience of description and simplification of operation, and do not indicate or imply that the referred device or element must have a specific orientation, be configured and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used only for descriptive purposes and are not intended to have a special meaning.

Example one

As shown in fig. 1 to 7, the present invention provides a prosthetic heart valve for implantation in a left ventricular inflow tract in place of a native mitral valve and also in a right ventricular inflow tract in place of a native tricuspid valve, the prosthetic heart valve comprising an outer stent 1, an inner stent 2, a covering membrane and a prosthetic leaflet 3.

Specifically, referring to fig. 2 and 3, the outer bracket 1 includes an upper lip section 11, a transition section 12 and a lower lip section 13, wherein the upper portion of the upper lip section 11 has a circular or D-shaped cross section, the lower portion of the upper lip section 11 is bent inward, the lower lip section 13 has a bell mouth shape, and the transition section 12 is connected between the upper lip section 11 and the lower lip section 13. The upper lip segment 11 is arranged on the native valve annulus, the upper part of the upper lip segment 11 protrudes out of the native valve annulus, the lower part of the upper lip segment 11 is bent inwards and is gently connected with the transition segment 12, the transition segment 12 is attached to the native valve leaflet 61, the lower lip segment 13 is arranged below the free end of the native valve leaflet 61, the outer stent 1 integrally presents a clip-shaped structure and is clipped at the native valve annulus and the native valve leaflet 61 to provide positioning and anchoring for the inner stent 2. In the heartbeat cycle, the outer support 1 is in radial reciprocating motion, and the outer support 1 is set to be in the structural form, so that the influence of the radial reciprocating motion on the inner support 2 can be reduced or even eliminated, and the deformation of the inner support 2 is prevented from being overlarge in the heartbeat cycle, so that the artificial valve leaf 3 can be opened and closed better, and the service life of the artificial valve leaf 3 can be prolonged. Preferably, the transition section 12 has a curved section profile, so that the transition section 12 can adapt to the shape of the native leaflets 61, reducing the compression on the native leaflets 61.

With continued reference to fig. 2 and 3, the inner support 2 is disposed inside the outer support 1, the inner support 2 includes an inflow section 21 and an outflow section 22, the inflow section 21 is in a bamboo hat shape, the outflow section 22 is in a cylindrical shape, the upper end of the inflow section 21 is connected to the upper lip section 11, the lower end of the inflow section 21 is connected to the upper end of the outflow section 22, and the lower end of the outflow section 22 extends downward beyond the lower lip section 13. The inner support 2 is hung in the outer support 1 to provide positioning and anchoring for the artificial valve leaflet 3, the artificial valve leaflet 3 is arranged in the outflow section 22 of the inner support 2 and is used for replacing the original valve leaflet 61, and the inflow section 21 is arranged in a bamboo hat shape, so that the effect of shock absorption can be achieved in a heartbeat cycle, the load stress on the artificial valve leaflet 3 is reduced, and the load of the outer support 1 during anchoring is reduced; through setting up outflow section 22 to cylindric, can act as artificial valve leaf 3's anchor carrier, under artificial valve leaf 3 damaged the condition, outflow section 22 can also use the sacculus to do suitable expansion for replace artificial valve leaf 3 (valve structure in the valve), because inner support 2 hangs in outer support 1, the structural localization and the anchor of outer support 1 are not influenced a little after inner support 2 expansion trades the valve.

In the present embodiment, the inner stent 2 and the outer stent 1 are integrally formed, and specifically, referring to fig. 4, after being braided into an integral stent by using shape memory elastic material (nitinol), the integral stent is partially folded by 180 degrees and heat-set into an integral structure of the inner and outer stents.

Referring to fig. 2, 5 and 6, the covering film comprises an inner covering film 41 and an outer covering film 42, the inner covering film 41 covers the inner wall of the inflow section 21 of the inner stent 2, so that blood can only pass through the artificial valve leaflet 3 when flowing from the atrium to the ventricle, the sealing performance of the inflow section 21 is effectively improved, and the paravalvular leakage is reduced; the outer coating film 42 is coated on the inner wall of the transition section 12 of the outer stent 1, and the outer coating film 42 is contacted with the native valve leaflet 61 again, so that the endothelialization area is increased, the native tissue is more beneficial to skin climbing, and the valve periphery leakage is reduced. Preferably, the inner covering film 41 and the inner stent 2 and the outer covering film 42 and the outer stent 1 are connected by suture. Preferably, the material of the inner film 41 and the outer film 42 is one or a combination of TPU, PET, e-PTFE and PTFE, and the thickness of the inner film 41 and the outer film 42 is 0.01-1 mm.

Referring to fig. 7, the artificial leaflet 3 includes a sewing edge 31 and a free edge 32, and the artificial leaflet 3 is sewn to the inner coating film 41 through the sewing edge 31. The artificial leaflet 3 comprises at least two leaflets, preferably three leaflets, the number of the artificial leaflet 3 may be the same as or different from that of the native leaflet 61, and the material may be a treated flexible polymer or a treated material of biological tissue, the flexible polymer may be polyolefin, elastomer, polyethylene glycol, polyether sulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, fluoropolymer, silicone polyester, silicone polymer and/or oligomer, and/or polylactone, and a block copolymer using the same; the biological tissue is preferably bovine pericardium tissue, porcine pericardium tissue, and small intestine submucosa tissue.

Referring to fig. 8, the method of using the prosthetic heart valve provided by the present invention is: the artificial heart valve is placed in a lumen of a conveyor and enters a ventricle through a guide wire, when the conveyor reaches a designated position, the artificial heart valve is released, an upper lip section 11 of an outer support 1 is placed on a native valve ring, the upper part of the upper lip section 11 protrudes out of the native valve ring, the lower part of the upper lip section 11 is bent inwards to be contacted with surrounding native tissues, a transition section 12 is attached to a native valve leaflet 61, a lower lip section 13 is positioned below the free end of the native valve leaflet 61, the outer support 1 is integrally in a clip-shaped structure and is clamped at the native valve ring and the native valve leaflet 61, an inner support 2 is placed inside the outer support 1, an artificial valve leaflet 3 is placed inside an inner support 2 to replace the native heart valve, and when the artificial heart valve is completely attached to a heart 6, the conveyor is evacuated.

Example two

The present embodiment provides a heart valve prosthesis, which is substantially the same as the first embodiment, and for the sake of simplicity, only the differences from the first embodiment will be described. In the present embodiment, referring to fig. 9 and 10, the inner support 2 and the outer support 1 are spliced, specifically, the inner support 2 and the outer support 1 may be made of a metal mesh structure, the splicing manner of the inner support 2 and the outer support may be one or a combination of sewing, welding and anchoring, preferably laser welding, a plurality of first welding terminals may be provided on the inner support 2, a plurality of second welding terminals which correspond to the first welding terminals one by one are arranged on the outer support 1, the number of the first welding terminals and the number of the second welding terminals can be 2-8, the first welding terminals and the second welding terminals are fixedly connected together through laser welding, more preferably, the connection pipe 5 may be sleeved outside the first and second welding terminals, and the connection pipe 5 may be made of metal having developing characteristics (such as platinum, gold, tantalum metal, and medical stainless steel).

In this embodiment, the prosthetic heart valve manufactured by splicing the inner and outer stents is easier to be placed in the organ cavity of the transporter because the folding phenomenon does not exist compared with the prosthetic heart valve integrally formed in the first embodiment. In contrast, the inner diameter of the lumen of the delivery instrument in this embodiment can be made smaller.

It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A prosthetic heart valve, comprising:

the outer support (1) comprises an upper lip section (11), a transition section (12) and a lower lip section (13), the cross section of the upper part of the upper lip section (11) is circular or D-shaped, the lower part of the upper lip section (11) is bent inwards, the lower lip section (13) is in a horn mouth shape, and the transition section (12) is connected between the upper lip section (11) and the lower lip section (13);

the inner support (2) is arranged inside the outer support (1) and comprises an inflow section (21) and an outflow section (22), the inflow section (21) is in a bamboo hat shape, the outflow section (22) is in a cylindrical shape, the upper end of the inflow section (21) is connected with the upper lip section (11), the lower end of the inflow section (21) is connected with the upper end of the outflow section (22), and the lower end of the outflow section (22) extends downwards to the outside of the lower lip section (13);

an artificial valve leaflet (3) arranged inside the outflow section (22) of the inner stent (2);

the membrane comprises an inner membrane (41) and an outer membrane (42), wherein the inner membrane (41) covers the inner wall of the inflow section (21) of the inner stent (2), and the outer membrane (42) covers the inner wall of the transition section (12) of the outer stent (1).

2. The prosthetic heart valve according to claim 1, wherein the transition section (12) is of curved section profile.

3. The prosthetic heart valve according to claim 1, wherein the inner and outer covering films (41, 42) are made of one or more of TPU, PET, e-PTFE, PTFE in combination.

4. The prosthetic heart valve according to claim 1, wherein the thickness of the inner and outer cover films (41, 42) is 0.01-1 mm.

5. The prosthetic heart valve according to claim 1, characterized in that the prosthetic leaflet (3) is in suture connection with the inner covering film (41).

6. The heart valve prosthesis according to claim 1, wherein the material of the prosthetic leaflet (3) is a flexible polymer or biological tissue.

7. The heart valve prosthesis according to any of the claims 1 to 6, characterized in that the inner stent (2) and the outer stent (1) are integrally woven from a shape memory elastic material.

8. The heart valve prosthesis according to any of the claims 1 to 6, characterized in that the inner stent (2) and the outer stent (1) are both made of a metal mesh structure and the inner stent (2) and the outer stent (1) are connected by welding.

9. The heart valve prosthesis according to claim 8, wherein a plurality of first welding terminals are disposed on the inner stent (2), a plurality of second welding terminals corresponding to the first welding terminals are disposed on the outer stent (1), and the first welding terminals and the second welding terminals are fixedly connected by welding.

10. The heart valve prosthesis according to claim 9, wherein a connection tube (5) is sleeved outside the first and second welding terminals, and the connection tube (5) is made of a metal having a developing property.