CN117100459A

CN117100459A - Valve stent and valve prosthesis

Info

Publication number: CN117100459A
Application number: CN202311360161.7A
Authority: CN
Inventors: 孙嘉康; 叶升成; 卢倩; 张汇海
Original assignee: Beijing Xinjian Technology Co ltd
Current assignee: Beijing Xinjian Technology Co ltd
Priority date: 2023-10-20
Filing date: 2023-10-20
Publication date: 2023-11-24

Abstract

The application discloses a valve support and a valve prosthesis. The valve stent comprises: the outer contour of the vertical projection of the outer layer bracket is elliptical or elliptical-like; an inner layer support arranged in the outer layer support and keeping a preset gap with the outer layer support; the inner layer bracket is used for constructing a cylindrical runner; the top of the inner layer bracket is detachably connected with the top of the outer layer bracket; the anchoring assembly comprises a plurality of anchoring hooks, the plurality of anchoring hooks are arranged at the bottom of the outer layer support or the bottom of the inner layer support, the plurality of anchoring hooks have different bending angles and lengths, and the tail end of each anchoring hook is abutted with the outer contour surface of the outer layer support. The outline of the support part of the outer support is matched with the shape of the original tricuspid valve annulus, and the valve support can be matched with the original tricuspid valve annulus with high degree without larger interference support size. Meanwhile, the anchoring hooks with different bending angles and lengths are adopted, so that a good anchoring effect is achieved.

Description

Valve stent and valve prosthesis

Technical Field

The application relates to the field of medical equipment, in particular to a valve bracket and a valve prosthesis.

Background

The heart suffers from a variety of valve diseases, either congenital or acquired, which directly or indirectly affect the physical and mental health of a person, and when heart valve lesions are severe, artificial valve prostheses are required to replace the diseased native valve. At present, percutaneous minimally invasive surgery is rapidly developed, and the technology can enter the body through a catheter to release the valve prosthesis, so that the effect of treating valve diseases is realized. Such valve prostheses have now become a research hotspot and have great market potential.

At present, the valve prosthesis enters the human body through the catheter, and the lesion valve can be supported by radial interference in order to effectively avoid paravalvular leakage. However, the radially-interference valve prosthesis is easy to interfere with the native tissues of a patient, and causes damage to the patient, and complications such as left ventricular outflow tract obstruction or atrioventricular conduction abnormality are caused.

Disclosure of Invention

The invention aims to provide a valve bracket or a valve prosthesis which has stable structure, reduces the damage to the primary tissues of a patient, can prevent paravalvular leakage and improve the treatment effect.

To achieve the above object, according to an aspect of the present invention, there is provided a valve stent comprising:

the outer contour of the vertical projection of the outer layer bracket is elliptical or elliptical-like;

an inner layer support arranged in the outer layer support and keeping a preset gap with the outer layer support; the inner layer support is used for constructing a cylindrical runner; the top of the inner layer bracket is detachably connected with the top of the outer layer bracket;

the anchoring assembly comprises a plurality of anchoring hooks, the plurality of anchoring hooks are arranged at the bottom of the outer layer support or the bottom of the inner layer support, the plurality of anchoring hooks are provided with different bending angles and lengths, and the tail end of each anchoring hook is abutted with the outer contour surface of the outer layer support.

In some embodiments, the outer contour of the vertical projection of the outer stent is divided into a plurality of curve sections, and the bending angle and the length of the anchoring hooks falling into the same curve section in the vertical projection are the same.

In some embodiments, the vertical projection of the inner stent is circular or annular; the projection extension lines of the anchoring hooks in the anchoring assembly intersect at the center of the circle or the circular ring and divide the circle or the circular ring uniformly.

In some embodiments, the vertical projection of the inner stent is elliptical or elliptical-like; the vertical projection of the inner layer support is concentric and parallel with the vertical projection of the outer layer support, namely, the centers of the vertical projection of the inner layer support and the vertical projection of the outer layer support coincide, and the vertical projection profile of the inner layer support is parallel with the vertical projection profile of the outer layer support.

In some embodiments, the outer stent comprises a tapered portion, a support portion, and a stent portion arranged in sequence along the valve stent axial direction; the tapered part is tapered from the top of the supporting part to the axial direction of the valve support; the junction of the support part and the bracket part is a horizontal interface;

the tail end of the anchoring hook in the anchoring assembly is aligned with the horizontal interface.

In some embodiments, the elliptical or elliptical-like profile is divided into a first curve segment, a second curve segment, and a third curve segment;

The first curve section comprises a long axis tip of an elliptic or elliptic-like outline, and a frame body which is vertically projected into the first curve section in the outer layer support is arranged in the partition area; the frame body which is vertically projected to be a second curve section is configured in the rear leaf area; the frame body projected in the vertical direction as a third curve section is arranged in the front leaf area.

In some embodiments, the number of the anchoring hooks is 6-9, and the number of the anchoring hooks corresponding to the first curve segment, the second curve segment and the third curve segment is 2-3.

In some embodiments, the anchoring hook vertically projected within the first curvilinear segment is a first anchoring hook; the anchoring hook vertically projected and positioned in the second curve section is a second anchoring hook; the anchoring hook vertically projected and positioned in the third curve section is a third anchoring hook;

the lateral projection height of the valve bracket is 28-33mm, and the lateral projection height of the first anchoring hook is 10-17mm; the side projection height of the second anchoring hook is 8-14mm; the lateral projection height of the third anchoring hook is 8-14mm.

In some embodiments, the anchoring hook includes a lower extension, a bend, and an upper extension;

the angle between the central line of the lower extension part of the first anchoring hook and the axis of the valve bracket is 20-35 degrees; the angle between the central line of the lower extension part of the second anchoring hook and the axis of the valve bracket is 25-35 degrees; the angle between the central line of the lower extension part of the third anchoring hook and the axis of the valve bracket is 25-50 degrees.

In some embodiments, the cradle portion comprises a circumferential array of a plurality of V-shaped structures, the support portion comprises a circumferential array of a plurality of W-shaped structures, and the taper portion comprises a circumferential array of a plurality of Y-shaped structures;

the number of the V-shaped structures, the number of the W-shaped structures and the number of the Y-shaped structures are in one-to-one correspondence, and the two top ends of each V-shaped structure are fixedly connected with the two bottom ends of the corresponding W-shaped structure; the two bottom ends of the Y-shaped structure are connected with the two top ends of the W-shaped structure, the Y-shaped structure is gradually contracted towards the axis direction of the valve support, and the top ends of the Y-shaped structure are provided with salient points connected with the inner support.

In some embodiments, the two top ends of the V-shaped structure and the two bottom ends of the W-shaped structure are integrally formed.

In some embodiments, the top end of the outer stent is higher than or equal to the top end of the inner stent and the lowest end of the outer stent is higher than or equal to the lowest end of the inner stent.

In some embodiments, the outer stent has a maximum support profile that is 1.1-1.2 times the profile of the native annulus of the human body.

In some embodiments, the ratio of the support profile perimeter of the inner stent to the support profile perimeter of the outer stent is 1:2-3:5.

According to another aspect of the present invention, there is also provided a valve prosthesis comprising a valve stent as described in the above technical solution, and a suture membrane and leaflets, the suture membrane being enclosed by the outer and inner stents to form a sealing structure; the valve blades are fixedly connected to the suture membrane at the side wall of the inner layer bracket.

According to a further aspect of the present application there is also provided the use of a valve stent or valve prosthesis as described above for the preparation of a medical device, preferably a heart valve prosthesis, more preferably a tricuspid valve prosthesis.

Compared with the prior art, the valve prosthesis has the following beneficial effects:

1. the outline of the supporting part of the outer layer bracket is elliptical or elliptical-like, and is matched with the shape of the original tricuspid valve annulus, so that the valve bracket has higher matching degree with the original tricuspid valve annulus without larger interference supporting size.

2. The valve bracket adopts a supporting contour matched with the tricuspid valve annulus, and the placement position is provided with a definite shape, so that the anchoring hooks arranged on the valve bracket adopt different bending angles and lengths according to the corresponding installation positions so as to adapt to the structural characteristics of the corresponding primary tissues at the installation positions, and the valve bracket has a better anchoring effect.

3. Compared with the prior art, the annular support provided by the application has smaller interference, can provide stable radial supporting force, and utilizes the anchoring hooks with different structures and positions to fix the annular support, so that the interference to the primary tissues is reduced, and the injury to a patient is lightened.

Drawings

FIG. 1 is a schematic illustration of a valve stent according to an embodiment of the present application;

FIG. 2 is a vertical projection of the valve stent of FIG. 1;

FIG. 3 is a schematic view of the structure of an outer stent according to some embodiments of the present application;

FIG. 4 is a vertical projection of the outer stent of FIG. 3;

FIG. 5 is a schematic view of the structure of an outer stent according to some embodiments of the present application;

FIG. 6 is a schematic view of an inner stent according to some embodiments of the present application;

FIG. 7 is a profile cut-away view of an outer stent according to some embodiments of the present application;

FIG. 8 is a schematic view of the structure of an anchoring hook in an anchoring assembly, according to some embodiments of the present application;

FIG. 9 is a diagram showing the number and placement of anchoring hooks according to some embodiments of the present application;

FIG. 10 is a schematic view of an anchor assembly mounted to an outer stent according to some embodiments of the present application;

FIG. 11 is an elevation view of a valve prosthesis according to some embodiments of the present application;

FIG. 12 is a top view of the valve prosthesis of FIG. 11;

fig. 13 is a schematic view of the installation of a valve prosthesis according to some embodiments of the present application.

Reference numerals:

100-outer layer stent; 110-a taper; 120-a support; 130-a bracket portion; 140-bump; 200-an inner layer bracket; 210-anchor point; 300-an anchor assembly; 310-a first anchoring hook; 320-a second anchoring hook; 330-a third anchoring hook; 301-a lower extension; 302-a bend; 303-an upward extension; 400-stitching the film; 500-leaflet assembly; 600-tricuspid valve annulus.

Description of the embodiments

In order that the above objects, features and advantages of the application will be readily understood, a more particular description of the application will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. The application may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit or scope of the application, which is therefore not limited to the specific embodiments disclosed below.

It should be understood that the described embodiments are merely some, but not all, embodiments of the application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

The terminology used in the embodiments of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this application and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

The terms "bottom," "top," "lower," "inner," "outer," and the like are used for convenience in describing and simplifying the description based on the orientation or positional relationship shown in the drawings, and do not denote or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the invention.

Unless specifically stated and limited otherwise, the terms "connected," "coupled" and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. The terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. The term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

As used herein, the term "axial" refers to the axial direction of the stent body, "over" is directly over, vertical projection refers to projection taken along the axial direction, and lateral projection refers to projection taken along a direction parallel to the axial direction.

As used herein, the term "abutting" refers to being in direct physical contact with each other.

Cardiac physiology

The anatomy of the heart is described below to aid in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart typically includes a muscular organ with four pumping chambers, where the flow of the heart is controlled at least in part by various heart valves (i.e., aortic, mitral, tricuspid, and pulmonary). The valve may be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., diastole and systole) to at least partially control the flow of blood to corresponding regions of the heart and/or vessels (e.g., pulmonary vessels, aorta, etc.).

The tricuspid valve is one of four heart valves, located between the right ventricle and the right atrium. The tricuspid valve ensures blood flow from the right atrium to the right ventricle. When the right atrium fills with blood, the tricuspid valve opens, allowing blood to enter the right ventricle. The right ventricle contracts then delivers blood to the pulmonary artery. Normally, the tricuspid valve closes tightly when the heart contracts, so that blood does not flow back to the right atrium. And when some causes result in tricuspid insufficiency, blood flows back from the right ventricle through the tricuspid valve, which is not closed, into the right atrium, defined as Tricuspid Regurgitation (TR). Severe TR causes or aggravates right heart failure, resulting in an increase in systemic venous pressure, blood stasis in the abdominal organs, and induction of clinical manifestations such as hepatosplenomegaly, ascites, peripheral edema, chest distress, weakness, etc., resulting in a significant decrease in the quality of life and life expectancy of the patient.

The tricuspid annulus is adjacent to the Right Coronary Artery (RCA), the atrioventricular node, and the aortic valve, all of which exert important physiological effects. Because of the too close distance to the tricuspid valve, the above structures are easily damaged when the tricuspid valve device is implanted and placed in the tricuspid valve annulus by interference clips, thereby introducing additional safety risks to the human body, such as aortic perforation risks, contact of the instrument with the atrioventricular node may induce acute and complete AV block; furthermore, since the tricuspid annulus is nearly entirely proximal to the right coronary artery, there is a higher risk of damage and/or ring cleavage of the right coronary artery during interventional annuloplasty.

The application discloses a valve bracket which is mainly applied to tricuspid valve intervention annuloplasty.

The valve stent comprises an outer stent, an inner stent and an anchoring component.

Outer layer support

The outer stent in the embodiments of the present application has a compressed state and an expanded state. When the outer layer support is in an expanded state, the outer contour of the vertical projection of the outer layer support is elliptical or elliptical-like. The part of the outer layer support which provides the maximum radial supporting force is the structure corresponding to the elliptic or elliptic-like vertical projection outline.

In some embodiments, the outer stent is a hollow mesh structure open at both ends, the hollow mesh structure having the property of being capable of being compressed and expanded. As can be seen in fig. 3 or 4, the outer stent comprises a tapered portion 110, a support portion 120 and a stent portion 130, which are arranged in sequence in the axial direction of the valve stent. The tapered part 110 is tapered from the top of the supporting part 120 towards the axial direction of the valve bracket; the interface of the support portion 120 and the bracket portion 130 is defined as a horizontal interface F.

In the application, the maximum radial support contour of the outer stent is the same as or similar to the contour of the tricuspid valve native valve annulus, and the size of the outer stent is larger than or slightly larger than that of the native valve annulus, so that a radial interference structure is formed relative to the native valve annulus, and a good fitting effect can be formed between a valve prosthesis adopting the valve stent and the position of the native valve. The valve stent provided by the application needs to have an interference fit effect with the Right Coronary Artery (RCA), the atrioventricular node and the aortic valve, and aims to prevent the valve prosthesis from being leaked around the valve after being installed, but the interference ratio of the valve stent support profile and the primary valve annulus profile is not too large in order to avoid the influence on the Right Coronary Artery (RCA), the atrioventricular node, the aortic valve and the like as much as possible. In some embodiments, the maximum support profile of the outer stent 100 is 1.1-1.2 times the native annulus profile.

In some embodiments, the stand portion 130 includes a circumferential array of multiple V-shaped structures, the support portion 120 includes a circumferential array of multiple W-shaped structures, and the tapered portion 110 includes a circumferential array of multiple Y-shaped structures. The number of the V-shaped structures, the number of the W-shaped structures and the number of the Y-shaped structures are in one-to-one correspondence, and the two top ends of each V-shaped structure are fixedly connected with the two bottom ends of the corresponding W-shaped structure; the two bottom ends of the Y-shaped structure are connected with the two top ends of the W-shaped structure, the Y-shaped structure is gradually contracted towards the axis direction of the valve support, and the top ends of the Y-shaped structure are provided with salient points connected with the inner support 200. The bumps are used to connect with the top of the inner stent 200.

In some embodiments, the two top ends of the V-shaped structure and the two bottom ends of the W-shaped structure are integrally formed. The support portion 120 and the support portion 130 are integrally formed, so that the outer support has a relatively stable radial supporting force.

In some embodiments, the frame body of the outer layer bracket can also adopt a net structure formed by grid cells, for example, the grid cells are diamond-shaped. It should be noted that, the structure of the outer stent is not particularly limited, and any mesh structure that can provide radial support and can be compressed and expanded falls within the scope of the present application.

In some embodiments, the outer stent is provided with a needling, one end of which is connected to the outer surface of the outer stent, and the other end of which is inclined toward the outer side of the outer stent. The needling of the outer stent can penetrate into the native tissue after the valve stent is delivered to the desired location, allowing the valve stent to be more firmly secured to the native annulus.

The outer stent may be formed from nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, phynox/Elgiloy (cobalt-chromium-nickel alloy), platinum-chromium, or other biocompatible metals known to those skilled in the art.

Alternatively, the outer stent may also be made of an elastically or plastically deformable material, such as balloon expandable, or may be a shape memory alloy that is responsive to a temperature change to transition between a contracted delivery state and an expanded deployment state.

In some embodiments, the outer stent may also be manufactured by cutting a nickel titanium alloy tube having an outer diameter of 4-50mm, the shaped profile being selected based on the actual native annulus size of the tricuspid valve of the user.

Inner layer support

The inner layer support is of a cylindrical structure with two open ends. The cylindrical structure has the property of being able to be compressed and expanded. The vertical projection of the inner layer bracket is circular or ring-shaped; or the vertical projection of the inner layer bracket is elliptical or elliptical-like.

In some embodiments, the inner support is cylindrical or approximately cylindrical, or is a cylindrical structure with bell mouth structures at both ends, see fig. 6, or is a cylindrical structure with straight cylinder at one end and bell mouth shape at one end.

In some embodiments, the outer contour of the vertical projection of the inner stent is elliptical or elliptical-like, and when an elliptical or elliptical-like structure is adopted, a layout structure which is the same as and parallel to the contour of the outer stent can be adopted.

In some embodiments, the main body portion of the inner layer support is provided with a plurality of hollow parts, which may be circular, grid-shaped, diamond-shaped or other patterns.

The inner stent may be formed from a metal such as nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, phynox/Elgiloy (cobalt-chromium-nickel alloy), platinum-chromium, or other biocompatible metals known to those skilled in the art.

Alternatively, the inner stent may also be made of an elastically or plastically deformable material, such as a balloon expandable, or may be a shape memory alloy that is responsive to a temperature change to transition between a contracted delivery state and an expanded deployment state.

In some embodiments, the inner stent is cut from a nickel titanium alloy tube having an outer diameter of 4-50mm, and the shaped profile is selected based on the actual native annulus size of the tricuspid valve of the user.

Anchor assembly

The anchoring assembly comprises a plurality of anchoring hooks which are arranged at the bottom of the outer layer bracket or the bottom of the inner layer bracket. Referring to fig. 1 and 6, a plurality of anchoring hooks are mounted to the bottom of the inner stent for example. The plurality of anchoring hooks have different bending angles and lengths, and the tail end of each anchoring hook is abutted with the outer contour surface of the outer layer bracket.

In embodiments where the outer stent includes tapered portion 110, support portion 120, and stent portion 130, the trailing ends of the anchoring hooks in the anchoring assembly are aligned with the horizontal interface F of support portion 120 and stent portion 130. The support portion 120 and the bracket portion 130 are cross-connected at an intersection having an intersection point, the intersection point being connected to form the horizontal interface F. The crossing point has superior hardness and rigidity compared to other portions of the support portion 120 and the bracket portion 130, and the end portion of each anchoring hook is disposed near the crossing point, and the end portion of the anchoring hook and the crossing point form a grip on the native tissue after the native tissue is hooked by the anchoring hook, and the crossing point having superior hardness and rigidity and the end portion of the anchoring hook form a grip force that is greater and has superior durability.

The anchor assemblies are arranged on the inner-layer support, in a preferable scheme, each anchor hook and the inner-layer support are integrally formed, the arrangement can reduce the sewing procedure of the valve support, enhance the connection strength with the inner-layer support and reduce the risk of unhooking of the valve support.

The tricuspid valve consists of four parts, namely, valve leaflet, valve annulus, chordae tendineae and papillary muscles. The leaflets are often named anterior, posterior and septal depending on where they are located. The anterior, posterior and septal leaflets attach to the papillary muscles of the ventricle via thin, firm cords called chordae tendineae, the papillary muscles serving to support the tricuspid valve She Digong chordae tendineae.

The setting rules of the plurality of anchoring hooks are as follows: in the expansion state, the outer contour of the vertical projection of the outer layer support is divided into a plurality of curve sections, and the bending angles and the lengths of the anchoring hooks of which the vertical projections fall into the same curve section are the same.

In one embodiment, an elliptical or elliptical-like profile is divided into a first curve segment C1, a second curve segment C2, and a third curve segment C3, see FIG. 7. The first curve segment C1 comprises a long axis tip of an elliptical or elliptical-like contour, and a frame body vertically projected as the first curve segment C1 in the outer layer bracket is configured to correspond to the leaf separation area; the frame body vertically projected to the second curve section C2 is configured to correspond to the rear leaf area; the shelf vertically projected as the third curve segment C3 is configured to correspond to the anterior leaflet area.

In the present application, the anchoring hook vertically projected to be located in the first curved section C1 is the first anchoring hook 310; the anchoring hook vertically projected to be positioned in the second curve section C2 is a second anchoring hook 320; the anchoring hooks vertically projected to lie within the third curved section C3 are third anchoring hooks 330.

In some embodiments, the number of anchoring hooks is 6-9, and the number of first, second and third anchoring hooks 310, 320, 330 is 2-3.

In one embodiment, the number of first anchoring hooks 310 is 3, the number of second anchoring hooks 320 is 3, and the number of third anchoring hooks 330 is 2.

In some possible embodiments, the lateral projected height of the outer stent is 28-33mm. The first anchoring hooks 310 (the lobed regions) have a lateral projected height of 8-14mm; the second anchoring hook 320 (posterior leaflet area) has a lateral projected height of 8-14mm; the third anchoring hooks 330 (anterior leaflet area) have a lateral projected height of 10-17mm.

In some embodiments, the anchoring hook includes a lower extension 301, a bend 302, and an upper extension 303, see fig. 8. The angle a between the central line of the lower extension 301 of the first anchoring hook 310 and the axis of the valve support is 25-50 degrees; the angle beta between the central line of the lower extension 301 of the second anchoring hook 320 and the axis of the valve support is 25-35 degrees; the angle gamma between the central line of the lower extension 301 of the third anchoring hook 330 and the axial center of the valve holder is 20-35 deg..

In some embodiments, the number and location design considerations of the plurality of anchoring hooks are: the vertical projection of the inner valve frame is exemplified as a circle. The circles are equally divided circumferentially, and in the embodiment with 8 anchoring hooks, the angle is 45 degrees, see fig. 9, and the included angle between the projection extension lines of each anchoring hook is 45 degrees. The 3 first anchoring hooks 310 are positioned on the structure corresponding to the first curved section C1 for hooking the partition. The 3 second anchoring hooks 320 are located on the structure corresponding to the second curved section C2 for hooking the posterior leaflet. The 2 third anchoring hooks 330 are located on the structure corresponding to the third curved section C3 for hooking the anterior leaflet to increase fixation with the native leaflet and chordae tendineae. No anchoring hooks are provided between the third anchoring hooks 330 and the first anchoring hooks 310 to prevent the anchoring hooks from hooking to the ventricular wall.

The top ends of the first, second and third anchoring hooks 310, 320 and 330 are flush with the horizontal interface F on the outer stent, and the lowest bottom end of the first anchoring hook 310 is lower than the lowest bottom ends of the second and third anchoring hooks 320 and 330. Fig. 8 shows a comparison of the structures of three anchoring hooks, and it can be seen that the longitudinal distance of the third anchoring hook 330 is longer than that of the first and second anchoring hooks 310 and 320, because of the original front She Jiaochang, the front leaf can be hooked better by such a design.

The tricuspid ring (TA) is normally an asymmetric saddle-shaped ellipsoid with 2 different portions: a larger C-shaped portion corresponds to the free walls of the right atrium and right ventricle; and a shorter, relatively straight portion corresponding to the septum and the compartment spacing. The anchoring assembly has the advantages that the anchoring hooks with different lengths are adopted, the primary parts to be anchored can be better matched, and the valve stent can be firmly anchored due to the improved matching degree.

In some embodiments, the anchor assembly is secured to the outer stent, see FIG. 10. When the anchoring assembly is fixed on the outer layer support, the number and the position design of the plurality of anchoring hooks are consistent with the design thought of fixing the anchoring assembly on the inner layer support, and the details are not repeated here.

The anchoring component is connected to the outer layer support, deformation affecting the inner layer support due to the fact that the anchoring hooks are driven by the native valve leaflets is reduced, and the angle adjustment of each anchoring hook is more flexible.

Connection of inner layer support and outer layer support

The inner layer support is a cylindrical structure with two open ends, and the top end of the cylindrical structure is provided with an anchor point for being connected with the outer layer support point. In some embodiments, referring to fig. 6, anchor point 210 is a ring-like structure with an intermediate opening.

In some embodiments, the protruding points of the outer stent are ring-shaped structures with a central opening, see fig. 3 and 5, and the protruding points 140 are located at the top end of the outer stent.

The outer layer support is sleeved outside the inner layer support, and the connection mode of the salient points on the inner layer support and the anchor points on the outer layer support comprises one or more of welding, riveting, crimping and sewing connection.

In one embodiment, the layered scaffold and the outer scaffold may also be attached by flexible strapping (e.g., metal or non-metal wires) strapping.

The perimeter of the support contour of the inner layer support is not less than one half of the perimeter of the support contour of the outer layer support.

In some embodiments, the anchoring hooks are provided with needling on the surface of the anchoring hooks bent towards the outer surface of the outer stent, the needling being directed towards the outer stent.

In some embodiments, the ratio of the support contour perimeter of the inner stent to the support contour perimeter of the outer stent is 1:2-3:5, e.g., 1:2-4:5 or 3:5-4:5.

In some embodiments, the lowest end of the outer stent should be higher than or equal to the lowest end of the inner stent, because: the outer stent is in contact with the native annulus, and the excessive bottom end of the outer stent interferes with the release effect of the valve stent, and in embodiments where the inner stent is connected to the anchoring assembly, the anchoring hooks need to extend from the bottom end of the inner stent beyond the outer stent, so the lowest end of the outer stent should not be lower than the lowest end of the inner stent.

Needling and developing points

In some embodiments, the surface of the anchoring hook and the connection part with the outer stent are also provided with a film coating layer, and the film coating layer can be arranged in a mode of film coating, woven cloth sewing and the like.

Optionally, the material of the covering film layer is selected from PET, PTFE, ePTFE, PU and other materials with good biocompatibility and easy endothelialization, or biological tissue materials such as pig pericardium and bovine pericardium.

In some embodiments, the outer stent is provided with a needle-punching, see fig. 5 or 9, for pinning, and may more stably fix the valve stent or the prosthesis prepared by the stent.

In some embodiments, one end of the needle is attached to the outer surface of the outer stent and the other end is angled toward the outside of the valve stent.

In some embodiments, the anchoring hooks are provided with development points thereon.

Valve prosthesis

In another aspect of the present invention, a valve prosthesis is provided that includes a valve stent, a suture membrane, and leaflets, the suture membrane surrounding the valve stent to form a seal.

In some embodiments, the suture membrane may be made of PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), ePTFE (expanded polytetrafluoroethylene), PU (polyamide), or other biocompatible and easily endothelialized materials, or biological tissue materials such as porcine pericardium and bovine pericardium.

The sewing film may be a mesh shape with dense mesh gaps made of yarns such as PET, PTFE, ePTFE, PU, provided that it is sufficient to block blood flowing through the valve prosthesis from flowing out of the outer stent sidewall.

Alternatively, the suture membrane may be attached to the outer or inner side wall of the outer stent, for example by non-metallic wire ties.

In some embodiments, the leaflet is fixedly attached to the suture membrane wrapped at the inner stent sidewall.

Optionally, the leaflets are sutured to a suture membrane wrapped around the side wall of the inner stent.

The valve prosthesis comprises two artificial valve leaves or three artificial valve leaves, one end of each valve leaf is stably connected with the suture membrane at the side wall of the inner layer bracket, and the other end of each valve leaf is a free end. In the working state, the artificial valve leaves replace the original valve leaves to realize the function of opening and closing the blood channel.

The material for manufacturing the valve leaflet component comprises biological tissue material or synthetic material, for example, the biological tissue material can be any one of bovine pericardium, sheep pericardium, pig pericardium or horse pericardium tissue, and the synthetic material can be polyurethane, polytetrafluoroethylene or organic silicon polyester.

The valve prosthesis has two forms, namely a compressed state and an expanded state, and the valve prosthesis is characterized in the expanded state unless special emphasis is given in the invention.

Use of the same

The present invention provides the use of the aforementioned valve stent or the aforementioned valve prosthesis for the preparation of a medical device.

In some embodiments, the medical device is a heart valve prosthesis.

In some embodiments, the medical device is a tricuspid valve prosthesis.

Example 1

The present embodiment provides a valve stent comprising an outer stent 100, an inner stent 200 and an anchor assembly 300. As shown in fig. 1 to 3, the inner stent 200 is placed inside the outer stent 100 while maintaining a predetermined gap with the outer stent 100; the inner support 200 is used for constructing a cylindrical runner; the top of the inner stent 200 is connected to the top of the outer stent 100. The anchor assembly 300 includes a plurality of anchor hooks. A plurality of anchoring hooks are mounted at the bottom of the inner stent 200, each anchoring hook has a different bending angle and length, and the tail end of each anchoring hook abuts against the outer contour surface of the outer stent 100.

The outer stent 100 includes a tapered portion 110, a support portion 120, and a stent portion 130 arranged in this order along the valve stent axial direction. The tapered portion 110 tapers from the top of the support portion 120 toward the axial direction of the valve stent. The support portion 120 and the bracket portion 130 meet at a horizontal interface F. The tapered portion 110 includes a plurality of Y-shaped structures in a circumferential array, the supporting portion 120 includes a plurality of W-shaped structures in a circumferential array, the bracket portion 130 includes a plurality of V-shaped structures in a circumferential array, the number of V-shaped structures, the number of W-shaped structures and the number of Y-shaped structures are in one-to-one correspondence, and two top ends of each V-shaped structure are integrally formed with two bottom ends of the corresponding W-shaped structure; the two bottom ends of the Y-shaped structure are connected with the two top ends of the W-shaped structure, the Y-shaped structure is gradually contracted towards the axis direction of the valve support, and the top ends of the Y-shaped structure are provided with salient points connected with the inner support 200. The bumps are used to connect with the top of the inner stent 200.

The inner support 200 has a cylindrical structure with two open ends, and as shown in fig. 6, two bell mouth structures are provided at the two ends. The outer contour of the vertical projection of the inner bracket 200 is circular. The main body of the inner layer bracket 200 is provided with a plurality of hollowed-out parts, which can be round, grid-shaped, diamond-shaped or other patterns.

It will be appreciated that the distance between the outer stent 100 and the inner stent 200 may be adjusted by the diameter of the inner stent 200, the smaller the diameter of the inner stent 200, the greater the distance between the outer stent 100 and the inner stent 200.

Since the placement of the valve stent or the manufactured prosthesis at the annulus, the shape of the inner stent 200 and the outer stent 100, and the connection relationship between the two are different, the performance of the valve stent is greatly affected, the distance and the structural arrangement of the inner stent 200 and the outer stent 100 are also important, and in the embodiment of the present invention, the support contour circumference of the inner stent 200 is not less than one half of the support contour circumference of the outer stent 100. In some embodiments, the ratio of the support profile perimeter of the inner stent 200 to the support profile perimeter of the outer stent 100 is 1:2-3:5, such as 1:2-4:5 or 3:5-4:5. Too small a distance between the outer stent 100 and the inner stent 200 can cause the radial support of the valve stent to be unstable, and the native annulus squeezes the inner stent 200 after implantation, affecting the proper functioning of the leaflets.

The inner stent 200 and the outer stent 100 are formed in a manner including, but not limited to, laser cutting, shearing, and wire cutting. Compared with a single-layer valve stent, the double-layer stent has better stability, when the outer-layer stent 100 is extruded by heart beating, the inner-layer stent 200 is prevented from being influenced, the normal opening and closing functions of valve leaflets are maintained, and better treatment effect is realized.

A plurality of anchoring hooks in the anchoring assembly 300 are mounted to the bottom of the inner stent 200, each of the anchoring hooks being integrally formed with the inner stent 200. Referring to fig. 7, the outer contour of the vertical projection of the outer stent 100 is divided into a first curve segment C1, a second curve segment C2 and a third curve segment C3. The anchoring hook vertically projected to be positioned in the first curve section C1 is a first anchoring hook 310; the anchoring hook vertically projected to be positioned in the second curve section C2 is a second anchoring hook 320; the anchoring hooks vertically projected within the second curvilinear segment C2 are third anchoring hooks 330. The first anchoring hooks 310 are disposed at a position intermediate the native anterior and posterior leaflets and serve to hook with the native leaflets and chordae tendineae. The second anchoring hook 320 is disposed at a position intermediate the native posterior leaflet and the septal leaflet, and is used to connect with the posterior She Gou; the third anchoring hook 330 is configured to be disposed at a position corresponding to a middle of the anterior leaflet and the septal leaflet of the native tissue, and is configured to be coupled to the anterior She Gou.

Referring to fig. 3 and 6, the top ends of the first, second and third anchor hooks 310, 320 and 330 are flush with the horizontal interface F on the outer frame body, and the lowermost bottom ends of the first anchor hook 310 are lower than the lowermost bottom ends of the second and third anchor hooks 320 and 330.

In some embodiments, the lateral projected height of the outer stent 100 is 28-33mm. The number of the first anchoring hooks 310 is 3, and the height of the side projection is 10-17mm; the angle a of the lower extension 301 of the first anchoring hook 310 to the axial center of the valve holder is 25-50 deg.. The number of the second anchoring hooks 320 is 3, the height of the side projection is 8-14mm, and the angle beta between the lower extension 301 of the second anchoring hooks 320 and the axis of the valve support is 25-35 degrees. The number of the third anchoring hooks 330 is 3, the height of the side projection is 8-14mm, and the angle gamma between the lower extension 301 of the third anchoring hooks 330 and the axis of the valve support is 20-35 degrees. The third anchoring hook 330 is longer in longitudinal distance than the first and second anchoring hooks 310 and 320 because of the original anterior She Jiaochang, which is better able to hook the anterior leaflet. The height and angle of the first and second anchoring hooks 310 and 320 are also designed according to the size of the native annulus and the surrounding native tissue, so that the anchoring assembly 300 of the present application enables a firm anchoring of the valve stent when the valve prosthesis is implanted at the site of the native annulus.

Example 2

The present embodiment provides a valve stent comprising an outer stent 100, an inner stent 200 and an anchor assembly 300. The structures of the outer stent 100 and the inner stent 200 in this embodiment may be the same as those of the outer stent 100 and the inner stent 200 in embodiment 1, and the difference is that the positions of the anchor assemblies 300 are different.

Referring to fig. 10, the anchor assemblies 300 are provided at the bottom of the outer stent 100, and each anchor hook is integrally formed with the outer stent 100. The top ends of the first, second and third anchor hooks 310, 320 and 330 are flush with the horizontal interface F on the outer layer frame body, and the lowest bottom end of the first anchor hook 310 is lower than the lowest bottom ends of the second and third anchor hooks 320 and 330.

In some embodiments, the lateral projected height of the outer stent 100 is 28-33mm. The number of the first anchoring hooks 310 is 3, and the height of the side projection is 10-17mm; the angle a between the central line of the lower extension 301 of the first anchoring hook 310 and the axial center of the valve holder is 25-50 deg.. The number of the second anchoring hooks 320 is 3, the height of the side projection is 8-14mm, and the angle beta between the lower extension 301 of the second anchoring hooks 320 and the axis of the valve support is 25-35 degrees. The number of the third anchoring hooks 330 is 2, the height of the side projection is 8-14mm, and the angle gamma between the lower extension 301 of the third anchoring hooks 330 and the axis of the valve support is 20-35 degrees. The third anchoring hook 330 has a longer longitudinal distance than the first and second anchoring hooks 310 and 320, so that the third anchoring hook 330 can better hook the anterior leaflet. The height and angle of the first and second anchoring hooks 310, 320 are also designed according to the size of the native annulus and surrounding native tissue, so that the anchoring assembly 300 of the present embodiment enables a firm anchoring of the valve stent when the valve prosthesis is implanted at the site of the native annulus.

The anchor assembly 300 is connected to the outer stent 100, which is advantageous in reducing deformation of the inner stent 200 due to the anchor hooks being driven by the native leaflets, and in which the angular adjustment of each anchor hook is more flexible.

Example 3

The present embodiments provide a valve prosthesis that may be used to replace the tricuspid valve of the human body.

This embodiment differs from embodiments 1, 2 in that the valve prosthesis further comprises a suture membrane 400 and a leaflet assembly 500, as shown in fig. 11 and 12. The suture membrane 400 integrally wraps the valve stent to form a sealing structure. The leaflet assembly 500 includes three leaflets, and the leaflet assembly 500 is sutured to the suture film 400 wrapped at the sidewall of the inner stent 200.

The suture membrane 400 is made of a material which has good biocompatibility and is easy to endothelialise, such as PET, PTFE, ePTFE, PU, or a biological tissue material such as pig pericardium and bovine pericardium.

The leaflet assembly 500 comprises three artificial leaflets, one end of which is stably connected to the suture film 400 on the inner stent 200, and the other end of which is a free end. In the working state, the artificial valve leaves replace the original valve leaves to realize the function of opening and closing the blood channel.

When the leaflet assembly 500 is in the open state, the free ends of the three leaflets are adjacent to the side wall of the inner stent 200, allowing blood to pass inside the inner stent 200; when the leaflet assembly 500 is in the closed state, the free ends of all of the leaflets are away from the suture membrane 400 of the side wall of the inner stent 200, and the free ends on adjacent two leaflets overlap at least partially.

When the valve prosthesis is implanted into a human body by the delivery system, the prosthesis is constrained within the delivery system at the implantation site within the human body, see fig. 13. The valve prosthesis is automatically expanded or expanded by balloon pressurization after release and is restrained on the tricuspid valve annulus 600 such that the long axis tip of the outer stent 100 is positioned intermediate the anterior leaflet and the septal leaflet. The first anchoring hooks 310 need to hook the native chordae, the second anchoring hooks 320 and the surface of the outer stent 100 are located at two sides of the native valve leaflet and can be clamped on the posterior leaflet by the interval therebetween, and the third anchoring hooks 330 and the surface of the outer stent 100 are located at two sides of the native valve leaflet and can be clamped on the anterior leaflet by the interval therebetween.

The maximum support contour of the outer layer stent 100 is slightly larger than the human body annulus (which can be 1.1-1.2 times of the annulus contour), when the outer layer stent 100 is implanted in the human body annulus, the outer layer stent 100 is clamped at the tricuspid valve ring 600 of the human body, so that the valve stent and the human body annulus are in proper interference fit to realize the limit of the valve prosthesis at the annulus and avoid paravalvular leakage.

The design has less damage to the native tissues of the patient on the premise of keeping a good radial supporting effect, and can also maintain the overall stability of the valve prosthesis.

Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, to thereby enable others skilled in the art to best utilize the invention. The invention is limited only by the claims and the full scope and equivalents thereof.

Claims

1. A valve stent, comprising:

2. The valve stent of claim 1, wherein the outer contour of the outer stent's vertical projection is divided into a plurality of curved segments, and the angle and length of the bending of the anchoring hooks that fall into the same curved segment are the same.

3. The valve stent of claim 2, wherein the vertical projection of the inner stent is circular or annular; the vertical projection extension lines of the anchoring hooks in the anchoring assembly are intersected with the circle center of the circular or circular ring shape and equally divide the circular or circular ring shape.

4. The valve stent of claim 1, wherein the vertical projection of the inner stent is elliptical or elliptical-like; the vertical projection of the inner layer bracket is concentric and parallel with the vertical projection of the outer layer bracket.

5. The valve stent of claim 1, wherein the outer stent comprises a tapered portion, a support portion, and a stent portion arranged in sequence along an axial direction of the valve stent; the tapered part is tapered from the top of the supporting part to the axial direction of the valve support; the junction of the support part and the bracket part is a horizontal interface;

6. The valve stent of claim 5, wherein the elliptical or elliptical-like profile is divided into a first curved segment, a second curved segment, and a third curved segment;

7. The valve stent of claim 6, wherein the number of anchoring hooks is 6-9, and the number of anchoring hooks corresponding to the first curve segment, the second curve segment, and the third curve segment is 2-3.

8. The valve stent of claim 6, wherein the anchoring hooks vertically projected within the first curvilinear segment are first anchoring hooks; the anchoring hook vertically projected and positioned in the second curve section is a second anchoring hook; the anchoring hook vertically projected and positioned in the third curve section is a third anchoring hook;

9. The valve stent of claim 8, wherein the anchoring hook comprises a lower extension, a bend, and an upper extension;

10. The valve stent of claim 6, wherein the stent portion comprises a circumferential array of a plurality of V-shaped structures, the support portion comprises a circumferential array of a plurality of W-shaped structures, and the taper portion comprises a circumferential array of a plurality of Y-shaped structures;

11. The valve holder of claim 10, wherein the two top ends of the V-shaped structure and the two bottom ends of the W-shaped structure are integrally formed.

12. The valve stent of claim 10, wherein the inner stent is a cylindrical structure with two ends open, and an anchor point for connecting with the bump is provided at the top end of the cylindrical structure.

13. The valve stent of claim 12, wherein the bump-to-anchor connection comprises one or more of a weld, a rivet, a crimp, a suture connection.

14. The valve stent of claim 1, wherein the outer stent is provided with a needle, one end of the needle is connected to the outer surface of the outer stent, and the other end of the needle is inclined towards the outer side of the valve stent.

15. The valve stent of claim 1, wherein the anchoring hooks are provided with needle sticks on a surface of the outer stent facing the outer surface, the needle sticks facing the outer stent.

16. The valve stent of claim 1, wherein a top end of the outer stent is higher than or equal to a top end of the inner stent and a bottom end of the outer stent is higher than or equal to a bottom end of the inner stent.

17. The valve stent of any one of claims 1 to 16, wherein the outer stent has a maximum support profile that is 1.1-1.2 times the native annulus profile.

18. The valve stent of claim 17, wherein the ratio of the support profile perimeter of the inner stent to the support profile perimeter of the outer stent is 1:2-3:5.

19. A valve prosthesis comprising the valve stent of any one of claims 1-18, and a suture membrane and leaflets, the suture membrane surrounding the outer and inner stents to form a sealed structure; the valve blades are fixedly connected to the suture membrane at the side wall of the inner layer bracket.