CN117717441A

CN117717441A - Heart valve prosthesis

Info

Publication number: CN117717441A
Application number: CN202410026968.5A
Authority: CN
Inventors: 杨威; 魏勇强; 闻靖
Original assignee: Shanghai Zhenyi Medical Technology Co ltd
Current assignee: Shanghai Zhenyi Medical Technology Co ltd
Priority date: 2024-01-08
Filing date: 2024-01-08
Publication date: 2024-03-19

Abstract

The present invention provides a heart valve prosthesis comprising: a stent, artificial valve leaflets and a balloon; the artificial valve leaf is fixed in the bracket; the bag body is connected with the bracket; the bag body comprises a commissure bag which is provided with a commissure bag notch facing the direction of the outflow end; the commissure pocket is arranged at the commissure of the adjacent artificial valve leaflet; the commissure pocket has an inflated state and a collapsed state; the commissure pocket is in a collapsed state when the artificial valve leaflet is opened; the commissure pocket is in an inflated state when the prosthetic leaflet is closed and contacts an adjacent prosthetic leaflet to seal. The present invention reduces the risk of thrombus at the commissures of the prosthetic valve She Zai by placing the commissure pocket.

Description

Heart valve prosthesis

Technical Field

The invention relates to the technical field of medical appliances, in particular to a heart valve prosthesis with a capsule body.

Background

The heart contains four heart 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. The atrium forms a ventricular outflow tract with the ventricle, the left ventricle forms a left ventricular outflow tract with the aorta, and the right ventricle forms a right ventricular outflow tract with the pulmonary artery. Valves with a one-way valve function are arranged at the positions of the chamber inflow channel and the chamber outflow channel, so that the normal flow of blood in the heart chamber is ensured. When this valve becomes problematic, cardiac hemodynamics changes and cardiac dysfunction, known as valvular heart disease. With the development of socioeconomic performance and the aging of population, the incidence of valvular heart disease is obviously increased, and research shows that the incidence of valvular heart disease of the aged population over 75 years is as high as 13.3%. At present, the traditional surgical treatment is still the first treatment means for patients with severe valvular disease, but for the aged, combined multi-organ diseases, patients with history of open chest surgery and poor cardiac function, the traditional surgical treatment has high risk and mortality rate, and some patients do not have the opportunity of operation. The transcatheter valve replacement/repair has the advantages of no need of chest opening, small trauma, quick patient recovery, and the like, and is widely focused by expert students. However, current heart valve prostheses also suffer from valve thrombosis, which occurs primarily at the leaflet commissures. When the valve is opened and closed, a part of the valve leaflet is always contacted, the blood flow velocity near the valve leaflet is low, and macromolecules in the blood cannot be washed away well, so that thrombus is formed.

Disclosure of Invention

In view of the shortcomings of the prior art, the present invention provides a heart valve prosthesis that reduces the risk of thrombosis at the commissures of the prosthetic valve She Zai by deploying commissure pockets.

To achieve the above object, the present invention provides a heart valve prosthesis having an inflow end and an outflow end, comprising: a stent, artificial valve leaflets and a balloon; the artificial valve leaflet is fixed in the bracket; the bag body is connected with the bracket; the capsule body comprises a commissure pocket which is provided with a commissure pocket notch facing the outflow end direction; the commissure bags are arranged at the commissures of two adjacent artificial valve leaflets;

the commissure pocket has an inflated state and a collapsed state; the commissure pocket is in the collapsed state when the artificial leaflet is open; the commissure pocket is in the inflated state when the prosthetic leaflet is closed and contacts an adjacent prosthetic leaflet for sealing.

Optionally, the capsule further comprises a leaflet base pouch having a leaflet base pouch gap toward the outflow end direction; the leaflet bottom sac is arranged corresponding to the bottom area of the artificial leaflet and is positioned outside the artificial leaflet; the bottom region of the artificial leaflet is not connected to the stent;

the leaflet base pouch has an expanded state and a collapsed state; the leaflet base pouch is in the collapsed state when the prosthetic leaflet is open and forms a flow path with the base region; the leaflet base pouch is in the expanded state when the prosthetic leaflet is closed and contacts the prosthetic leaflet to close the flow passage.

Optionally, the maximum outer diameter of the leaflet base pouch along the length of the fixed edge of the prosthetic leaflet in the expanded state is less than or equal to 1/2 of the total length of the fixed edge.

Optionally, the leaflet base pouch is capable of conforming snugly to a target subject in the inflated state.

Optionally, the porosity of the side of the leaflet base pocket distal to the prosthetic leaflet is greater than the porosity of the other side proximal to the prosthetic leaflet, and/or the endothelialization rate of the side of the leaflet base pocket distal to the prosthetic leaflet is greater than the endothelialization rate of the other side proximal to the prosthetic leaflet.

Optionally, a side of the leaflet base pouch away from the prosthetic leaflet is made of one or a combination of materials of polyethylene terephthalate, polyvinylpyrrolidone, polylactic acid, and polycaprolactone, and a side of the leaflet base pouch near the prosthetic leaflet is made of one or a combination of materials of polyurethane, polytetrafluoroethylene, and polyethylene.

Optionally, the balloon further comprises a peripheral valve pouch having a peripheral valve pouch gap toward the outflow end; the valve circumferential pocket is disposed along the entire circumference of the heart valve prosthesis;

the valve circumferential pocket has an expanded state and a collapsed state; the valve circumferential pocket is in the collapsed state when the prosthetic leaflet is open and forms a gap with a target object; the valve peripheral capsular bag is in the expanded state and conforms to a target subject when the prosthetic leaflet is closed.

Optionally, the valve circumferential pocket is disposed proximate the inflow end and at least partially outside of the stent.

Optionally, the valve circumferential pouch has a greater rate of endothelialization than the commissure pouch.

Optionally, the capsule further comprises a leaflet center pouch having a center pouch gap toward the outflow end direction; the center sac of the valve leaflet is arranged on the axis of the artificial valve leaflet when the artificial valve leaflet is closed;

the leaflet center bladder has an expanded state and a collapsed state; the leaflet center pocket is in the collapsed state when the prosthetic leaflet is open; the leaflet center bladder is in the expanded state when the prosthetic leaflet is closed and contacts the prosthetic leaflet to seal the prosthetic leaflet.

Optionally, the balloon further comprises a leaflet center balloon frame, the leaflet center balloon frame is respectively connected with the leaflet center balloon and the stent, and the leaflet center balloon is located at the top end of the leaflet center balloon frame far away from the inflow end.

Optionally, the leaflet center balloon frame is an elongated rod.

Optionally, the commissure pocket has a rate of endothelialization greater than, equal to, or less than a rate of endothelialization of the leaflet center pocket.

Compared with the prior art, the heart valve prosthesis provided by the invention has at least the following advantages:

the heart valve prosthesis is also provided with a sac body, the sac body is connected with the bracket, the sac body at least comprises a commissure sac, and the commissure sac is provided with a commissure sac notch facing the outflow end direction; the commissure bags are arranged at the commissures of two adjacent artificial valve leaflets; the commissure pocket has an inflated state and a collapsed state; the commissure pocket is in the collapsed state when the artificial leaflet is open; the commissure pocket is in the inflated state when the prosthetic leaflet is closed and contacts an adjacent prosthetic leaflet for sealing. So configured, the commissures of adjacent artificial valve leaflets can be completely flushed by blood flow, avoiding thrombus formation due to blood flow stagnation, and thus reducing the risk of thrombus at the commissures of the artificial valve She Zai.

The balloon may further include a leaflet base pouch having a leaflet base pouch gap toward the outflow end direction; the leaflet bottom sac is arranged corresponding to the bottom area of the artificial leaflet and is positioned outside the artificial leaflet; the bottom region of the artificial leaflet is not connected to the stent; the leaflet base pouch has an expanded state and a collapsed state; the leaflet base pouch is in the collapsed state when the prosthetic leaflet is open and forms a flow path with the base region; the leaflet base pouch is in the expanded state when the prosthetic leaflet is closed and contacts the prosthetic leaflet to close the flow passage. So configured, the bottom dead zone of the artificial valve leaflet is advantageously flushed, reducing the risk of thrombosis, while at the same time, perivalvular leakage may be reduced when the valve is closed.

The balloon may further include a peripheral valve pocket having a peripheral valve pocket notch toward the outflow end; the valve circumferential pocket is disposed along the entire circumference of the heart valve prosthesis; the valve circumferential pocket has an expanded state and a collapsed state; the valve circumferential pocket is in the collapsed state when the prosthetic leaflet is open and forms a gap with a target object; the valve circumferential pocket is in the expanded state when the prosthetic leaflet is closed and conforms to a target subject (i.e., native tissue). This reduces the valve to native tissue clearance and thus the paravalvular leakage.

The balloon may further include a leaflet center pouch having a center pouch gap toward the outflow end direction; the center sac of the valve leaflet is arranged on the axis of the artificial valve leaflet when the artificial valve leaflet is closed; the leaflet center bladder has an expanded state and a collapsed state; the leaflet center pocket is in the collapsed state when the prosthetic leaflet is open; the leaflet center bladder is in the expanded state when the prosthetic leaflet is closed and contacts the prosthetic leaflet to seal the prosthetic leaflet. Thereby, it is advantageous to reduce leakage through the center of the valve.

Drawings

Those of ordinary skill in the art will appreciate that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention, in which "tissue" means native tissue. Wherein:

FIG. 1 is a schematic view of the overall structure of a heart valve prosthesis provided in accordance with one embodiment of the present invention;

FIG. 2 is a schematic top view of a heart valve prosthesis provided in accordance with one embodiment of the present invention when closed;

FIG. 3 is a schematic top view of a heart valve prosthesis provided according to a comparative example when open;

FIG. 4 is a schematic top view of a heart valve prosthesis provided according to a comparative example when closed;

FIG. 5 is a schematic top view of a heart valve prosthesis provided in accordance with one embodiment of the present invention when deployed with a commissure pocket at the commissure, wherein the commissure pocket is in a collapsed state;

FIG. 6 is a schematic top view of a heart valve prosthesis provided in accordance with one embodiment of the present invention with a commissure pocket disposed at the commissure when closed, wherein the commissure pocket is in an inflated state;

FIG. 7 is a schematic view of a partial structure of a heart valve prosthesis according to an embodiment of the present invention when the heart valve prosthesis is opened, with a commissure pocket at the commissure, wherein arrows indicate blood flow directions when the heart valve prosthesis is opened, and blood flow is from an inflow end to an outflow end;

FIG. 8 is a schematic view of a commissure pocket in a collapsed state, wherein arrows indicate blood flow direction when blood flow is from an inflow end to an outflow end with a heart valve prosthesis open, according to an embodiment of the present invention;

FIG. 9 is a schematic view of a commissure pocket in an inflated state, wherein arrows indicate the reverse flow direction of blood flow when the heart valve prosthesis is closed, according to an embodiment of the present invention;

FIG. 10 is a schematic view of various shapes of a commissure pocket, provided according to an embodiment of the present invention;

FIG. 11 is a state diagram of a dead zone where blood can flow back and easily form a blood flow stagnation at the bottom of a prosthetic leaflet when the heart valve prosthesis provided according to the comparative example is closed;

FIG. 12 is a state diagram of thrombus formation in the dead zone of the heart valve prosthesis when opened, as a result of not being flushed away in time, provided in accordance with a comparative example;

FIG. 13 is a schematic view of a heart valve prosthesis provided with a leaflet base pocket in a base region of a prosthetic leaflet, in accordance with an embodiment of the present invention;

FIG. 14 is a schematic view of a heart valve prosthesis according to one embodiment of the present invention in a state in which a flow path is formed between a leaflet base pouch and a base region of a prosthetic leaflet when opened;

FIG. 15 is a schematic structural view of a leaflet base pouch in a collapsed state, provided in accordance with an embodiment of the present invention;

FIG. 16 is a schematic view of a heart valve prosthesis according to one embodiment of the present invention in a state in which the capsular bag expands and closes the flow passage at the bottom of the leaflet when closed;

FIG. 17 is a schematic view of a leaflet base pouch in an inflated state, according to an embodiment of the present invention;

FIG. 18 is a schematic illustration of a configuration of a heart valve prosthesis provided with a circumferential pocket of the valve disposed about the periphery proximate the inflow end in accordance with an embodiment of the present invention;

FIG. 19 is a schematic view of a heart valve prosthesis according to one embodiment of the present invention in a state in which a gap is formed between a circumferential pocket of the valve and native tissue when opened;

FIG. 20 is a schematic view of a heart valve prosthesis according to one embodiment of the present invention in a state in which the valve circumferential pocket fills the gap between the prosthesis and native tissue when closed;

FIG. 21 is a schematic structural view of a leaflet center bladder provided in accordance with an embodiment of the present invention;

FIG. 22 is a schematic structural view of a heart valve prosthesis provided in accordance with an embodiment of the present invention with the leaflet center pocket in a collapsed state when opened;

fig. 23 is a schematic structural view of a heart valve prosthesis provided in accordance with an embodiment of the present invention with the leaflet center pocket in an expanded state when closed.

Wherein reference numerals are as follows:

100-heart valve prosthesis; 110-a bracket; 120-skirt edge; 130-artificial leaflet; 140-suture; 150-capsule body; 151-commissure pocket; 1511-commissure pocket gap; 152-leaflet bottom pouch; 1521-leaflet bottom capsular bag opening; 153-a valve circumferential pocket; 1531-valve circumferential capsular bag opening; 154-leaflet center capsular bag; 1541-a central capsular bag opening; 155-leaflet center balloon stent.

Detailed Description

The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.

As used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" is generally used in the sense of comprising "and/or" and the term "several" is generally used in the sense of comprising "at least one," the term "at least two" is generally used in the sense of comprising "two or more," and the term "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or implying any particular order of such items. Thus, a feature defining a "first", "second", or the like may explicitly or implicitly include one or at least two such feature, and the terms "one end" and "the other end" generally refer to the respective two portions, including not only the endpoints, but also the terms "mounted", "connected", or the like, are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed therewith; the connection may be mechanical connection, direct connection or indirect connection through an intermediate medium, and may be internal connection of two elements or interaction relationship of two elements. Furthermore, as used in this disclosure, an element disposed on another element generally only refers to a connection, coupling, cooperation or transmission between two elements, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, and should not be construed as indicating or implying any spatial positional relationship between the two elements, i.e., an element may be in any orientation, such as inside, outside, above, below, or on one side, of the other element unless the context clearly indicates otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

As used herein, "outer diameter" refers to the diameter of a circle, corresponding to the diameter dimension, for a circular structure, and to the diameter of its circumscribed circle, for a non-circular structure; the "axial direction" corresponds to the direction in which the axis is located for a cylindrical structure and the axial direction corresponds to the length direction of the extension path for a non-cylindrical structure. The term "axial" as described herein refers to the direction of the central axis of the heart valve prosthesis, "circumferential" refers to the direction about the central axis of the heart valve prosthesis, and "radial" refers to the direction perpendicular to the axial direction of the heart valve prosthesis.

The present invention aims to provide a heart valve prosthesis that improves the performance of the heart valve prosthesis by arranging at least one of the commissure pocket, the leaflet base pocket, the valve peripheral pocket, and the leaflet center pocket.

The heart valve prosthesis provided by the present invention is convertible between a radially compressed state and a radially expanded state. The heart valve prosthesis is folded over the delivery system in a radially compressed state during delivery and expands out of the delivery system to a radially expanded state upon reaching the implantation site. It is to be understood that the heart valve prostheses provided herein can be used with a variety of delivery systems and can be implanted via a variety of delivery means.

The heart valve prosthesis provided by the present invention may be adapted for implantation in the native aortic, pulmonary, mitral and tricuspid valves.

The following description refers to the accompanying drawings. Those skilled in the art will appreciate that the following preferred embodiments can be freely combined and stacked without conflict.

Referring to fig. 1 and 2, an embodiment of the present application provides a heart valve prosthesis 100 having opposite inflow and outflow ends, the outflow end of the heart valve prosthesis 100 being above and the inflow end of the heart valve prosthesis 100 being below, as viewed from the placement position of fig. 1.

The heart valve prosthesis 100 includes a stent 110, artificial leaflets 130, and a balloon 150. The heart valve prosthesis 100 also typically includes a skirt 120, the skirt 120 being adapted to be sewn to the stent 110 as a sealing member. The skirt 120 may comprise at least one of an inner skirt and an outer skirt. The skirt 120 may be wrapped around the Zhou Xiangzuo of the stent 110, effectively preventing paravalvular leakage. The entirety of the stent 110, prosthetic leaflet 130 and skirt 120 are connected to one another primarily by sutures 140. The material of the suture 140 is not limited, and for example, various known conventional materials such as PTFE (polytetrafluoroethylene), ePTFE (expanded polytetrafluoroethylene), PE (polyethylene) and the like may be selected.

The stent 110 is capable of providing several functions to the heart valve prosthesis 100, including: a body structure for use as a valve; carrying an inner artificial leaflet 130; a connection structure (hanger or fixed ear) with the delivery system, etc. The support 110 is a ring frame, which may be woven or cut, but is not limited thereto. The bracket 110 may be made of various suitable materials. Alternatively, the stent 110 is a biocompatible metal frame or a laser cut solid metal tube made of a material such as nitinol, titanium alloy, cobalt chrome alloy, MP35n, 316 stainless steel, or other biocompatible metals as known to those skilled in the art, preferably a nitinol material. The stent 110 may also be selected from materials that are elastically or plastically deformable, such as balloon-expandable materials.

The skirt 120 may be selected from knitted, woven, braided polyester fabrics such as PTFE (polytetrafluoroethylene), ePTFE (expanded polytetrafluoroethylene), and the like.

The artificial leaflet 130 is fixed to the inside of the stent 110; the prosthetic leaflet 130 is capable of dynamically switching between open and closed states. The prosthetic leaflets 130 coapt or meet in sealing abutment in the closed state. The artificial leaflet 130 may be selected from biological tissue, such as chemically stable tissue from a heart valve of an animal (e.g., a pig), or from pericardial tissue of an animal such as bovine (bovine pericardium) or ovine (ovine pericardium) or porcine (porcine pericardium) or equine (equine pericardium), preferably bovine pericardium tissue. The prosthetic leaflet 130 can also be made from small intestine submucosal tissue.

Referring to fig. 3 and 4, at the commissure 1 of the adjacent artificial valve leaflet 130, when the artificial valve leaflet 130 is opened and closed, a part of the commissure 1 is always in contact, the blood flow velocity near this is low, and macromolecules in the blood cannot be washed away well, so that thrombus is easily formed. Referring back to fig. 1 and 2, to reduce the risk of thrombosis of the prosthetic leaflet 130 at the commissure 1, the heart valve prosthesis 100 further includes a balloon 150.

The material of the capsule body 150 may be a biological tissue material, such as chemically stable tissue of a heart valve from an animal (e.g., pig), or an animal's pericardial tissue such as bovine (bovine pericardium) or ovine (ovine pericardium) or porcine (porcine pericardium) or equine (equine pericardium), or a polymeric material such as PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), PU (polyurethane), PE (polyethylene), PVP (polyvinylpyrrolidone), PLA (polylactic acid), PCL (polycaprolactone), etc. The specific material of bladder 150 is not limited. Balloon 150 may be attached to stent 110 by stitching, adhesive, or other means, but the manner of attachment is not limited. It should be noted that, in the following description, any one of the sachets included in the balloon 150 needs to be connected to the bracket 110.

In one embodiment, balloon 150 includes a commissure pocket 151, with commissure pocket 151 having commissure pocket notches 1511 toward the outflow end (see fig. 8-10). The commissure pocket 151 is a bag with a cavity. The commissure pocket 151 has an inflated state and a collapsed state, and is transitionable between the collapsed state and the inflated state.

Referring to fig. 5 and 6, the commissure pocket 151 is disposed at the commissure 1 of two adjacent artificial leaflets 130, such that the commissure pocket 151 is directly between the commissures 1 of the adjacent artificial leaflets 130. The commissure pocket 151 can be used to separate adjacent two prosthetic leaflets 130.

As shown in fig. 5, 7 and 8, when the artificial leaflet 130 is opened, the commissure pocket 151 is in a collapsed state, so that the commissure 1 of the adjacent artificial leaflet 130 is easily completely flushed by blood flow, and stagnation of blood flow is avoided, thereby reducing the risk of thrombus at the commissure 1.

As further shown in connection with fig. 6 and 9, when the prosthetic leaflet 130 is closed, the commissure pocket 151 expands under reverse blood flow pressure and contacts the adjacent prosthetic leaflet 130, sealing against leakage.

As shown in (a) - (e) of fig. 10, the commissure pocket 151 can have a variety of shapes, such as: drop-shaped, rectangular, semicircular, etc. Preferably, the commissure pocket 151 is drop-shaped, which saves material and provides better antithrombotic and sealing effects.

In some embodiments, the commissure pocket 151 has 1 large commissure pocket gap 1511 (i.e., large opening), as in (a) - (c) of fig. 10. In other embodiments, the commissure pocket 151 has a plurality of small commissure pocket notches 1511, as shown in fig. 10 (e) - (e). The shape of the commissure pocket gap 1511 is not limited, including, but not limited to, the circular and rectangular shapes depicted in the figures.

The commissure pockets 151 may be disposed on the inside and outside of the stent 110, or partially disposed on the inside of the stent 110, while partially disposed on the outside of the stent 110.

Preferably, the commissure pocket 151 is of various suitable low endothelialization materials, which further reduces the risk of thrombosis of the commissure 1. The commissure pocket 151 may be selected from PU (polyurethane), PTFE (polytetrafluoroethylene), PE (polyethylene), or other known relatively slow endothelialization materials. The commissure pocket 151 can be made of one or more combined materials.

It has also been found that when the artificial leaflet 130 is closed, blood flows back in the direction indicated by the arrow in fig. 11, and a back flow vortex is easily formed at the bottom of the artificial leaflet 130, resulting in a dead zone where blood flow stagnates; when the artificial leaflet 130 is opened, blood macromolecules in the dead zone cannot be washed away in time, and thrombus is formed, as shown in fig. 12. In this regard, as shown in fig. 13, in one embodiment, the balloon 150 further includes a leaflet base pocket 152, the leaflet base pocket 152 also having a leaflet base pocket notch 1521 toward the outflow end (see fig. 15 and 17); the leaflet base pocket 152 is disposed corresponding to the base region of the prosthetic leaflet 130 and is located outside of the prosthetic leaflet 130. Meanwhile, the bottom region of the artificial leaflet 130 is not connected to the stent 110. The leaflet base pockets 152, which are circumferentially disposed with the base region of the prosthetic leaflet 130, may be distributed at a central or off-center location of the base region. The center of the bottom region is the location closest to the inflow end, and the size of the bottom region should be selected so as not to reduce the strength of the prosthetic leaflet 130 when attached to the stent 110 and not to cause the prosthetic leaflet 130 to collapse.

The leaflet base pouch 152 has an expanded state and a collapsed state and is transitionable between the collapsed state and the expanded state.

Referring to fig. 14 and 15, when the artificial leaflet 130 is opened, the leaflet base pocket 152 is in a collapsed state, and a flow channel a is formed between the base region of the artificial leaflet 130 and the leaflet base pocket 152, i.e., a flow channel a is formed between the inner side of the leaflet base pocket 152 and the outer side of the artificial leaflet 130, so that the blood flow can wash the "dead zone" through the flow channel a, thereby reducing the risk of the base thrombosis of the artificial leaflet 130. For ease of understanding, the location of the bottom region of the prosthetic leaflet 130 corresponding to the leaflet bottom pocket 152 is shown in phantom line a in fig. 16 as unattached to the stent 110.

In contrast, as shown in fig. 16 and 17, when the artificial leaflet 130 is closed, the leaflet base pocket 152 is in an expanded state under the blood flow reversal pressure, so that the leaflet base pocket 152 is fully contacted with the outer side of the artificial leaflet 130, thereby closing the original flow channel a and avoiding the blood flow leakage.

The leaflet base pocket 152 should not be too large and too small; when the artificial valve leaflet 130 is too large, the connection strength of the artificial valve leaflet 130 and the bracket 110 is easily reduced, so that the artificial valve leaflet 130 collapses; if the amount is too small, the effect is not obvious. In this regard, it is preferable that the maximum outer diameter of the leaflet base pocket 152 in the expanded state along the length of the fixed edge of the prosthetic leaflet 130 is less than or equal to 1/2 of the total length of the fixed edge, or that the center angle α of the leaflet base pocket 152 in the expanded state along the length of the fixed edge of the prosthetic leaflet 130 is less than or equal to 1/2 β, β being the center angle of the fixed edge of the prosthetic leaflet 130; thus, when the artificial valve leaflet 130 is closed, the connection strength between the artificial valve leaflet 130 and the bracket 110 is high enough to avoid the problem of collapse of the artificial valve leaflet 130. The center angle α refers to the center angle of the circular arc between the two ends of the leaflet base 152 in the longitudinal direction of the fixed edge, the center angle β refers to the center angle of the circular arc between the two ends of the fixed edge of the single artificial leaflet 130 in the longitudinal direction, and the center is the center of the artificial leaflet 130 when closed. It should be further noted that, for the structure of the artificial leaflet 130 (including the fixed edge and commissures), those skilled in the art will understand with reference to the prior art and will not be described in detail.

With continued reference to fig. 14, the leaflet base pocket 152 is positioned in a location corresponding to the base region of the prosthetic leaflet 130, specifically outside the base region, and is capable of overlapping the base region to form a flow path a when the prosthetic leaflet 130 is opened, while the leaflet base pocket 152 is expanded to a size that ensures contact with the outside of the prosthetic leaflet 130 for sealing.

Preferably, the leaflet base pocket 152 is capable of more closely conforming to the native tissue in the expanded state (see fig. 16), reducing valve-to-native tissue clearance and paravalvular leakage.

Preferably, the porosity of the leaflet base pocket 152 on the side distal from the prosthetic leaflet 130 is greater than the porosity on the other side proximal to the prosthetic leaflet 130. In this way, the risk of thrombosis is reduced on the side of the leaflet base pocket 152 that is close to the artificial leaflet 130, and endothelialization is rapid on the side that is close to the native tissue, ensuring that the leaflet base pocket 152 is in close apposition with the native tissue.

Preferably, the rate of endothelialization of the side of the leaflet base pocket 152 distal from the prosthetic leaflet 130 is greater than the rate of endothelialization of the other side proximal to the prosthetic leaflet 130, which is also antithrombotic and promotes endothelialization.

In this embodiment, the leaflet base pocket 152 employs a material having a high porosity and a relatively high endothelialization rate on the side proximal to the native tissue and a relatively low endothelialization rate on the side distal from the native tissue. Alternatively, the leaflet base pouch 152 may be made from PET (polyethylene terephthalate), PVP (polyvinylpyrrolidone), PLA (polylactic acid), PCL (polycaprolactone) or other known relatively faster endothelialization rate material on the side proximal to the native tissue (i.e., distal to the prosthetic leaflet 130), while the leaflet base pouch 152 may be made from PU (polyurethane), PTFE (polytetrafluoroethylene), PE (polyethylene) or other known relatively slower endothelialization rate material on the side distal to the native tissue, and may be a combination of one or more of these materials.

The expanded form of the leaflet base pouch 152 is not limited, and may have various shapes such as a drop type, a rectangular shape, a semicircular shape, etc., and preferably a drop type. The leaflet base pouch 152 has 1 leaflet base pouch indentation 1521 or a plurality of leaflet base pouch indentations 1521, which are not limited. The shape of the leaflet base pocket gap 1521 is also not particularly limited, such as circular, rectangular, or various other shapes.

It is to be understood that the base region of each artificial leaflet 130 is provided with a leaflet base pocket 152. The leaflet base pocket 152 may be disposed either inside or outside of the stent 110, or the leaflet base pocket 152 may be disposed partially inside of the stent 110 and partially outside of the stent 110.

Referring to fig. 18-20, in one embodiment, the balloon 150 further includes a circumferential valve pouch 153, the circumferential valve pouch 153 having a circumferential valve pouch opening 1531 toward the outflow end for collapse and expansion. The valve circumferential pocket 153 is disposed along the entire circumference of the heart valve prosthesis 100. Preferably, a valve circumferential pocket 153 is provided near the inflow end. The circumferential valve pocket 153 is at least partially disposed outside of the stent 110, and preferably the entire circumferential valve pocket 153 is disposed around the stent 110 outside of the stent 110. The valve circumferential pocket 153 may be one bag arranged continuously along the entire circumference, or a plurality of individual bags arranged at intervals along the circumference. Correspondingly, the valve circumferential pocket notch 1531 may be one large opening or a plurality of separate small openings. The valve circumferential pocket notch 1531 may be any suitable shape, such as circular, rectangular, etc., as this is not a limitation of the present application.

The circumferential valve pouch 153 has an expanded state and a collapsed state. As shown in connection with fig. 19, when the prosthetic leaflet 130 is open, the valve circumferential pocket 153 is in a collapsed state and forms a gap with the native tissue such that blood flow may partially pass through the gap of the valve circumferential pocket 153 with the native tissue. As shown in fig. 20, when the prosthetic leaflet 130 is closed, the valve circumferential pocket 153 can closely conform to the native tissue when in an expanded state, thereby filling the gap between the heart valve prosthesis 100 and the native tissue with the valve circumferential pocket 153, and reducing paravalvular leakage.

As a preferred embodiment, the balloon 150 includes both commissure pockets 151, leaflet base pockets 152, and valve circumferential pockets 153, wherein the leaflet base pockets 152 are further from the inflow end than the valve circumferential pockets 153.

Preferably, the valve circumferential pocket 153 is made of a material having a high porosity and good endothelialization, such as, optionally, PET (polyethylene terephthalate), PVP (polyvinylpyrrolidone), PLA (polylactic acid), PCL (polycaprolactone) or other known relatively rapid endothelialization materials, and is made of a combination of one or more of these materials. In particular, it is contemplated that the rate of endothelialization of the valve circumferential pocket 153 is greater than the rate of endothelialization of the commissure pocket 151, and (or) that the rate of endothelialization of the valve circumferential pocket 153 is greater than the rate of endothelialization of the leaflet center pocket 154 described below.

The valve circumferential pocket 153 may have various shapes, illustratively, a drop shape, a rectangular shape, a semicircular shape, etc., preferably a drop shape.

Referring back to fig. 1, and as shown in conjunction with fig. 21-23, in yet another embodiment, the balloon 150 may include a leaflet center pocket 154. Referring to fig. 23, the leaflet center pocket 154 has a center pocket notch 1541 toward the outflow end direction, the center pocket notch 1541 may be one or more, and the shape of the center pocket notch 1541 is not limited; the leaflet center pocket 154 is disposed on the axis of the prosthetic leaflet 130 when closed. The leaflet center pocket 154 also has an expanded state and a collapsed state.

Referring to fig. 22, when the prosthetic leaflets 130 are open, the leaflet center pocket 154 is in a collapsed state, at which time each of the prosthetic leaflets 130 is facing outwardly away from the leaflet center pocket 154 and is not in contact with the leaflet center pocket 154 for blood flow through the heart valve prosthesis 100. Referring to fig. 23, when the prosthetic leaflets 130 are closed, the leaflet center pocket 154 is in an expanded state, and each prosthetic leaflet 130 is in full contact with the leaflet center pocket 154, acting as a seal, reducing leakage through the valve center.

Further, the balloon 150 further includes a leaflet center balloon frame 155, the leaflet center balloon frame 155 being connected to the leaflet center balloon 154 and the stent 110, respectively, the leaflet center balloon 154 being located at a tip of the leaflet center balloon frame 155 remote from the inflow end. In this manner, the leaflet center balloon frame 155 serves to support the leaflet center capsular bag 154, and is simple in construction without affecting blood flow through the valve.

The leaflet center capsule body frame 155 may be disposed at a central position or off-central position of the heart valve prosthesis 100, without special requirements for this, as long as the leaflet center pocket 154 is ensured to be located on the axis when the prosthetic leaflet 130 is closed. The leaflet center balloon frame 155 can be any slender rod, such as a straight rod, a bent rod and the like, and has small size and small influence on blood flow. The material of the leaflet center balloon frame 155 may be metal, polymeric material, or composite material. The leaflet center balloon stent 155 may be a hollow tube or a solid rod, preferably a hollow tube.

The leaflet center pocket 154 can be of a variety of shapes, alternatively, in some embodiments, such as a drop-type, rectangular, semi-circular, etc., preferably drop-type.

The rate of endothelialization of the leaflet center pocket 154 is less than, equal to, or greater than the rate of endothelialization of the commissure pocket 151. In particular, the leaflet center pocket 154 is formed from a relatively slow endothelialization rate material, such as PU (polyurethane), PTFE (polytetrafluoroethylene), PE (polyethylene), or the like, and may be formed from a combination of one or more of these materials.

In summary, the heart valve prosthesis provided by the invention has at least the following advantages:

(1) The commissure pocket 151 can enable the commissure 1 of the adjacent artificial valve leaflet 130 to be completely flushed by blood flow, so that thrombus caused by blood flow stagnation is avoided;

(2) The leaflet base pocket 152 can flush the base dead zone of the prosthetic leaflet 130, reducing the risk of thrombosis, while at the same time partially reducing paravalvular leakage when the valve is closed;

(3) The valve circumferential pocket 153 may reduce valve and tissue gaps, thereby reducing paravalvular leakage;

(4) The leaflet center pocket 154 reduces leakage through the center of the valve.

The foregoing description is only illustrative of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention in any way, and any changes and modifications made by those skilled in the art in light of the foregoing disclosure will be deemed to fall within the scope and spirit of the present invention.

Claims

1. A heart valve prosthesis having an inflow end and an outflow end, comprising: a stent, artificial valve leaflets and a balloon; the artificial valve leaflet is fixed in the bracket; the bag body is connected with the bracket; the capsule body comprises a commissure pocket which is provided with a commissure pocket notch facing the outflow end direction; the commissure bags are arranged at the commissures of two adjacent artificial valve leaflets;

2. The heart valve prosthesis of claim 1, wherein the balloon further comprises a leaflet base pouch having a leaflet base pouch gap toward the outflow end direction; the leaflet bottom sac is arranged corresponding to the bottom area of the artificial leaflet and is positioned outside the artificial leaflet; the bottom region of the artificial leaflet is not connected to the stent;

3. The heart valve prosthesis of claim 2, wherein the leaflet base pouch, in the expanded state, has a maximum outer diameter along the length of the fixed edge of the prosthetic leaflet that is less than or equal to 1/2 of the total length of the fixed edge.

4. The heart valve prosthesis of claim 2, wherein the leaflet base pouch is capable of conforming snugly to a target subject in the expanded state.

5. The heart valve prosthesis of claim 2, wherein the porosity of the side of the leaflet base pocket remote from the prosthetic leaflet is greater than the porosity of the other side proximate to the prosthetic leaflet and/or the endothelialization rate of the side of the leaflet base pocket remote from the prosthetic leaflet is greater than the endothelialization rate of the other side proximate to the prosthetic leaflet.

6. The heart valve prosthesis of claim 5, wherein the side of the leaflet base pouch distal from the prosthetic leaflet is made of one or a combination of materials of polyethylene terephthalate, polyvinylpyrrolidone, polylactic acid, and polycaprolactone, and the side of the leaflet base pouch proximal to the prosthetic leaflet is made of one or a combination of materials of polyurethane, polytetrafluoroethylene, and polyethylene.

7. The heart valve prosthesis of claim 1, wherein the balloon further comprises a peripheral valve pocket having a peripheral valve pocket notch toward the outflow end; the valve circumferential pocket is disposed along the entire circumference of the heart valve prosthesis;

8. The heart valve prosthesis of claim 7, wherein the valve circumferential pocket is disposed proximate the inflow end and at least partially outside of the stent.

9. The heart valve prosthesis of claim 7, wherein the valve circumferential pocket has a greater rate of endothelialization than the commissure pocket.

10. The heart valve prosthesis of claim 1, wherein the balloon further comprises a leaflet center pocket having a center pocket gap toward the outflow end direction; the center sac of the valve leaflet is arranged on the axis of the artificial valve leaflet when the artificial valve leaflet is closed;

11. The heart valve prosthesis of claim 10, wherein the balloon further comprises a leaflet center balloon frame connecting the leaflet center balloon and the stent, respectively, the leaflet center balloon being located at a tip of the leaflet center balloon frame distal from the inflow end.

12. The heart valve prosthesis of claim 11, wherein the leaflet center balloon frame is an elongate stem.

13. The heart valve prosthesis of claim 10, wherein the commissure pocket has a rate of endothelialization greater than, equal to, or less than a rate of endothelialization of the leaflet center pocket.