CN117100459A - Valve stent and valve prosthesis - Google Patents

Abstract

The invention discloses a valve stent and a valve prosthesis. The valve stent includes: an outer stent, the vertically projected outer contour of which is oval or elliptical-like; an inner stent, which is placed within the outer stent and maintains a predetermined gap with the outer stent; the inner stent is To construct a cylindrical flow channel; the top of the inner bracket and the top of the outer bracket are detachably connected; the anchor component includes a plurality of anchor hooks, and the plurality of anchor hooks are installed at the bottom of the outer bracket or the bottom of the inner bracket, The plurality of anchor hooks have different bending angles and lengths, and the tail end of each anchor hook is in contact with the outer contour surface of the outer bracket. In the valve stent of the present application, the contour of the outer stent support part matches the shape of the native tricuspid valve annulus, and can achieve a high degree of matching with the native tricuspid valve annulus without the need for a larger interference support size. At the same time, anchoring hooks with different bending angles and lengths are used to achieve good anchoring effects.

Description

Valve stents and valve prostheses

Technical field

The present invention relates to the field of medical devices, specifically to valve stents and valve prostheses.

Background technique

The heart will suffer from various valve diseases due to congenital or acquired reasons. These valve diseases will directly or indirectly affect people's physical and mental health. When the heart valve disease is serious, artificial valve prostheses need to be used to replace the diseased natural valves. At this stage, percutaneous minimally invasive surgery is developing rapidly. This technology can enter the body through a catheter and release the valve prosthesis to achieve the effect of treating valve diseases. This kind of valve prosthesis has become a research hotspot and has huge market potential.

At present, valve prostheses that enter the human body through catheters use radial interference to prop up the diseased valve in order to effectively avoid paravalvular leakage. However, radial interference valve prostheses can easily interfere with the patient's native tissue and cause harm to the patient, leading to complications such as left ventricular outflow tract obstruction or abnormal atrioventricular conduction.

Contents of the invention

The purpose of the present invention is to provide a valve stent or valve prosthesis that has a stable structure, reduces damage to the patient's native tissue, prevents paravalvular leakage, and improves therapeutic effects.

In order to achieve the above objectives, one aspect of the present invention provides a valve stent, including:

The outer stent has an elliptical or elliptical-like outer contour in vertical projection;

The inner bracket is placed in the outer bracket and maintains a predetermined gap with the outer bracket; the inner bracket is used to construct a cylindrical flow channel; the top of the inner bracket is in contact with the outer bracket. The top of the layer bracket is removable;

An anchor assembly includes a plurality of anchor hooks. The plurality of anchor hooks are installed at the bottom of the outer bracket or the bottom of the inner bracket. The plurality of anchor hooks have different bending angles and lengths. The tail end of each anchor hook Contact with the outer surface of the outer bracket.

In some embodiments, the vertically projected outer contour of the outer stent is divided into a plurality of curved segments, and the anchoring hooks that vertically projected into the same curved segment have the same bending angle and length.

In some embodiments, the vertical projection of the inner stent is a circle or annular shape; the projected extension line of the anchor hook in the anchor assembly intersects at the center of the circle or annular shape and evenly divides the circle. shaped or circular.

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

In some embodiments, the outer stent includes a tapered portion, a supporting portion and a stent portion arranged sequentially along the axial direction of the valve stent; the tapering portion extends from the top of the supporting portion toward the axis of the valve stent. The direction gradually shrinks; the interface between the support part and the bracket part is a horizontal interface;

The tail end of the anchor hook in the anchor 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 segment includes the tip of the major axis of an elliptical or elliptical profile, and the frame body of the outer stent whose vertical projection is the first curve segment is configured in the partition area; the vertical projection is the second curve The frame body of the segment is arranged in the posterior leaf area; the frame body of the vertically projected third curve segment is arranged in the front leaf area.

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

In some embodiments, the anchor hook whose vertical projection is located in the first curve segment is the first anchor hook; the anchor hook whose vertical projection is located in the second curve segment is the second anchor hook; and the vertical projection is located in the third curve segment. The anchor hook inside is the third anchor hook;

The lateral projection height of the valve stent is 28-33mm; the lateral projection height of the first anchor hook is 10-17mm; the lateral projection height of the second anchor hook is 8-14mm; the lateral projection height of the third anchor hook Height is 8-14mm.

In some embodiments, the anchor hook includes a downward extension, a bend, and an upward extension;

The angle between the center line of the downward extension of the first anchor hook and the axis of the valve stent is 20-35°; the angle between the center line of the downward extension of the second anchor hook and the axis of the valve stent is 25-35°. °; The angle between the center line of the lower extension of the third anchor hook and the axis of the valve stent is 25-50°.

In some embodiments, the support portion includes a circumferential array of a plurality of V-shaped structures, the support portion includes a circumferential array of a plurality of W-shaped structures, and the tapered portion includes a circumferential array of a plurality of Y-shaped structures. structure;

The numbers of V-shaped structures, W-shaped structures and Y-shaped structures correspond one to one. The two top ends of each V-shaped structure are fixedly connected to the two bottom ends of the corresponding W-shaped structure; the two bottom ends of the Y-shaped structure are connected to the W-shaped structure. The two top ends of the Y-shaped structure are connected, the Y-shaped structure gradually shrinks toward the axial direction of the valve stent, and a protruding point connected to the inner layer stent is provided on its top end.

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 of the outer stent is higher than or equal to the top 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 maximum support profile of the outer stent is 1.1-1.2 times the profile of the human native valve annulus.

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, a valve prosthesis is also provided, including the valve stent as described in the above technical solution, and a suture membrane and a valve leaflet. The suture membrane is surrounded by the outer stent and the inner layer. The stent is used to form a sealing structure; the leaflets are fixedly connected to the suture membrane at the side wall of the inner stent.

According to another aspect of the present invention, there is also provided a use of the above-mentioned valve stent or valve prosthesis for preparing a medical device. The medical device is preferably a heart valve prosthesis, and more preferably a tricuspid valve prosthesis.

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

1. For the valve stent in this application, the outline of the support part of the outer stent is oval or elliptical, matching the shape of the native tricuspid valve annulus, and can match the shape of the native tricuspid valve annulus without requiring a large interference support size. The cusp annulus has a high degree of matching.

2. The valve stent in this application adopts a support profile that matches the tricuspid valve annulus. Since the placement position has a certain shape, the anchor hooks provided on the valve stent adopt different bending angles and lengths according to the corresponding installation positions. , to adapt to the structural characteristics of the corresponding native tissue at its installation location, and have a better anchoring effect.

3. The annulus stent provided in this application has a smaller interference ratio than the existing technology, but can provide stable radial support force, and uses anchor hooks of different structures and positions to fix the valve stent, reducing Interference with native tissue reduces harm to patients.

Description of drawings

Figure 1 is a schematic structural diagram of a valve stent according to an embodiment of the present application;

Figure 2 is a vertical projection of the valve stent shown in Figure 1;

Figure 3 is a schematic structural diagram of an outer stent according to some embodiments of the present application;

Figure 4 is a vertical projection of the outer bracket shown in Figure 3;

Figure 5 is a schematic structural diagram of an outer stent according to some embodiments of the present application;

Figure 6 is a schematic structural diagram of an inner stent according to some embodiments of the present application;

Figure 7 is an outline diagram of an outer stent according to some embodiments of the present application;

Figure 8 is a schematic structural diagram of an anchor hook in an anchor assembly according to some embodiments of the present application;

Figure 9 is a diagram showing the number and position design ideas of anchor hooks according to some embodiments of the present application;

Figure 10 is a schematic structural diagram of an anchor assembly installed on an outer bracket according to some embodiments of the present application;

Figure 11 is a front view of a valve prosthesis according to some embodiments of the present application;

Figure 12 is a top view of the valve prosthesis shown in Figure 11;

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

Reference signs:

100-outer bracket; 110-tapering part; 120-support part; 130-bracket part; 140-bump; 200-inner bracket; 210-anchor point; 300-anchoring component; 310-first anchor hook; 320-second anchoring hook; 330-third anchoring hook; 301-lower extension; 302-bending part; 303-upper extension; 400-suture membrane; 500-valve leaflet assembly; 600-tricuspid valve annulus .

Implementation

In order to make the above objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, the present invention can be implemented in many other ways different from those described here. Those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited to the specific implementation disclosed below.

It should be clear that the described embodiments are only some of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without making creative efforts fall within the scope of protection of this application.

The terminology used in the embodiments of the present application is only for the purpose of describing specific embodiments and is not intended to limit the present application. As used in the embodiments and the appended claims, the singular forms "a," "the" and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise.

The orientation or positional relationship indicated by the terms "bottom", "top", "lower", "inner", "outer", etc. are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description. It is not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore is not to be construed as a limitation of the invention.

Unless otherwise clearly stated and limited, the terms "connected" and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected or through an intermediate connection. The medium is indirectly connected, which can be the internal connection between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood on a case-by-case basis.

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 used 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, "above" means directly above, vertical projection refers to the projection along the axial direction, and lateral projection refers to the projection along the direction parallel to the axial direction. projection.

As used herein, the term "butting" refers to 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 consists of a muscular organ with four pumping chambers, in which the flow of the heart is driven, at least in part, by various heart valves (i.e., aortic, mitral, tricuspid, and pulmonic valves) control. The valves 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 control, at least in part, blood to corresponding regions of the heart and/or vessels (e.g., pulmonary vessels, aorta, etc.) flow.

The tricuspid valve is one of the four heart valves located between the right ventricle and the right atrium. The tricuspid valve ensures the flow of blood 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 then contracts to deliver blood to the pulmonary artery. Normally, the tricuspid valve closes tightly when the heart contracts, preventing blood from flowing back into the right atrium. When some causes cause tricuspid regurgitation, blood flows back from the right ventricle through the incompetent tricuspid valve into the right atrium, which is defined as tricuspid regurgitation (TR). Severe TR causes or aggravates right heart failure, leads to increased systemic venous pressure, abdominal organ congestion, and induces clinical manifestations such as hepatosplenomegaly, ascites, peripheral edema, and chest tightness and fatigue, leading to a significant decrease in patients' quality of life and life expectancy.

The tricuspid annulus is adjacent to the right coronary artery (RCA), atrioventricular node, and aortic valve, and the above structures all play important physiological roles. Because it is too close to the tricuspid valve, when the tricuspid valve device is implanted and placed in the tricuspid valve annulus through an interference card, the above structures are easily damaged, thus posing additional safety risks to the human body, such as aortic perforation. Risks: Contact between the device and the atrioventricular node may induce acute and complete AV block; in addition, because almost the entire anterior and posterior annulus of the tricuspid valve annulus is close to the right coronary artery, the right coronary artery is injured during interventional annuloplasty. and/or a higher risk of ring dehiscence.

The invention discloses a valve stent, which is mainly used in tricuspid valve interventional annuloplasty.

The valve stent in this application includes an outer stent, an inner stent and an anchoring component.

outer bracket

The outer stent in the embodiment of the present application has a compressed state and an expanded state. When the outer stent is in an expanded state, the vertically projected outer contour of the outer stent is oval or elliptical-like. The part of the outer stent that provides the maximum radial support force is the structure corresponding to the elliptical or elliptical vertical projection profile.

In some embodiments, the outer stent is a hollow mesh structure with openings at both ends, and the hollow mesh structure has the characteristics of being able to be compressed and expanded. As shown in FIG. 3 or FIG. 4 , the outer stent includes a tapered portion 110 , a supporting portion 120 and a stent portion 130 that are sequentially arranged along the axial direction of the valve stent. The tapered portion 110 tapers from the top of the supporting portion 120 toward the axial direction of the valve stent; the interface between the supporting portion 120 and the stent portion 130 is defined as the horizontal interface F.

In this application, the maximum radial support profile of the outer stent is the same or similar to the profile of the native annulus of the tricuspid valve, and the size is larger or slightly larger than the native annulus, forming a radial interference structure relative to the native annulus. For use with The valve prosthesis of the valve stent can form a good fit with the native valve position. The valve stent provided in this application needs to have an interference fit with the right coronary artery (RCA), atrioventricular node and aortic valve. Its purpose is to prevent paravalvular leakage after the valve prosthesis is installed. However, in order to The impact on the right coronary artery (RCA), atrioventricular node and aortic valve should be avoided as much as possible, and the interference ratio between the valve stent support contour and the native valve annulus contour will not be too large. 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 support portion 130 includes a circumferential array of a plurality of V-shaped structures, the support portion 120 includes a circumferential array of a plurality of W-shaped structures, and the tapered portion 110 includes a circumferential array of a plurality of Y-shaped structures. The numbers of V-shaped structures, W-shaped structures and Y-shaped structures correspond one to one. The two top ends of each V-shaped structure are fixedly connected to the two bottom ends of the corresponding W-shaped structure; the two bottom ends of the Y-shaped structure are connected to the W-shaped structure. The two top ends of the Y-shaped structure are connected, and the Y-shaped structure gradually shrinks toward the axial direction of the valve stent, and is provided with a bump connected to the inner stent 200 at its top end. The bumps are used to connect with the top of the inner bracket 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 part 120 and the bracket part 130 are integrally formed, so that the outer bracket has a relatively stable radial support force.

In some embodiments, the frame body of the outer stent may also adopt a network structure composed of grid units. For example, the grid units are in a diamond shape. It should be noted that this application does not specifically limit the structure of the outer stent. Any grid structure that can provide radial support and can be compressed and expanded falls within the protection scope of this application.

In some embodiments, the outer stent is provided with needles, one end of the needles is connected to the outer surface of the outer stent, and the other end is inclined toward the outside of the outer stent. The needles on the outer stent can penetrate into the native tissue after the valve stent is delivered to the predetermined position, so that the valve stent can be more firmly fixed at the native valve annulus.

The material forming the outer stent can be made of nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox/Elgiloy (cobalt-chromium-nickel alloy), platinum-chromium and other metals, or those skilled in the art Other known biocompatible metals.

Optionally, the outer stent may also be made from an elastically or plastically deformable material, such as a balloon-expandable, or may be shape memory that responds to temperature changes to transition between a contracted delivery state and an expanded deployed state. alloy.

In some embodiments, the outer stent can also be cut and manufactured from nickel-titanium alloy tubing with an outer diameter of 4-50 mm, and the contour size after shaping is selected according to the actual native annulus size of the user's tricuspid valve.

inner stent

The inner bracket is a cylindrical structure with openings at both ends. The cylindrical structure has the characteristics of being able to be compressed and expanded. The vertical projection of the inner stent is circular or annular; or the vertical projection of the inner stent is elliptical or elliptical-like.

In some embodiments, the inner support is cylindrical or nearly cylindrical, or has a cylindrical structure with bell mouth structures at both ends, see Figure 6 , or has a straight cylindrical shape at one end and a horn at the other end. Mouth-shaped cylindrical structure.

In some embodiments, the vertically projected outer contour of the inner stent is elliptical or elliptical-like. When it adopts an elliptical or elliptical-like structure, the same and parallel layout structure as the outline of the outer stent can be used.

In some embodiments, the main body part of the inner stent is provided with multiple hollows, which may be circular, grid-shaped, diamond-shaped or other patterns.

The material forming the inner stent can be selected from metals such as Nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox/Elgiloy (cobalt-chromium-nickel alloy), platinum-chromium, or those skilled in the art. Other known biocompatible metals.

Alternatively, the inner stent may also be made from an elastically or plastically deformable material, such as a balloon-expandable, or may be shape memory that responds to temperature changes to transition between a contracted delivery state and an expanded, deployed state. alloy.

In some embodiments, the inner stent is cut and manufactured from nickel-titanium alloy tubing with an outer diameter of 4-50 mm, and the shaped contour size is selected according to the actual native annulus size of the user's tricuspid valve.

Anchor components

The anchoring component includes a plurality of anchor hooks, and the plurality of anchor hooks are installed at the bottom of the outer bracket or the bottom of the inner bracket. Referring to Figures 1 and 6, multiple anchor hooks are installed at the bottom of the inner bracket as an example for explanation. The plurality of anchor hooks have different bending angles and lengths, and the tail end of each anchor hook is in contact with the outer contour surface of the outer bracket.

In the embodiment in which the outer bracket includes the tapered part 110 , the support part 120 and the bracket part 130 , the tail end of the anchor hook in the anchor assembly is aligned with the horizontal interface F of the support part 120 and the bracket part 130 . The support part 120 and the bracket part 130 are cross-connected at the intersection, and the cross-connection has an intersection, and the intersection points are connected to form the horizontal interface F. The intersection point has better hardness and rigidity than other parts of the support part 120 and the bracket part 130. The end of each anchor hook is set near the intersection point. After the anchor hook hooks the native tissue, the end of the anchor hook The intersection point and the intersection point form a clamping of the native tissue. The clamping force formed by the intersection point with good hardness and stiffness and the end of the anchor hook will be larger and more durable.

The anchoring component is arranged on the inner stent. In a preferred solution, each anchor hook is integrally formed with the inner stent. This arrangement can reduce the sewing process of the valve stent, enhance the connection strength with the inner stent, and reduce Risk of valve stent decoupling.

The tricuspid valve is composed of four parts: leaflets, annulus, chordae tendineae, and papillary muscles. The valve leaflets are usually named anterior leaflet, posterior leaflet and septal leaflet according to their location. The anterior, posterior, and septal leaflets are attached to the papillary muscles of the ventricles by thin, strong cords called chordae tendineae, which provide chordal support for the tricuspid valve leaflets.

The setting rules for multiple anchor hooks are: in the expanded state, the vertically projected outer contour of the outer stent is divided into multiple curve segments, and the anchor hooks whose vertical projections fall into the same curve segment have the same bending angle and length.

In one embodiment, the elliptical or elliptical-shaped outline 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 includes the tip of the major axis of an elliptical or quasi-elliptical profile. The vertical projection of the outer stent as the first curve segment C1 is configured to correspond to the septal leaf area; the vertical projection is the second curve. The frame of segment C2 is configured to correspond to the posterior leaf area; the frame of vertically projected third curve segment C3 is configured to correspond to the front leaf area.

In this application, the anchor hook vertically projected in the first curve segment C1 is the first anchor hook 310; the anchor hook vertically projected in the second curve segment C2 is the second anchor hook 320; the vertical projection located in the second curve segment C2 is the second anchor hook 320. The anchor hook in the three-curve section C3 is the third anchor hook 330 .

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

In one embodiment, the number of first anchor hooks 310 is three, the number of second anchor hooks 320 is three, and the number of third anchor hooks 330 is two.

In some possible embodiments, the lateral projected height of the outer stent is 28-33 mm. The lateral projection height of the first anchor hook 310 (septal leaf area) is 8-14mm; the lateral projection height of the second anchor hook 320 (posterior leaf area) is 8-14mm; the third anchor hook 330 (anterior leaf area) The lateral projection height is 10-17mm.

In some embodiments, the anchor hook includes a lower extension portion 301, a bent portion 302, and an upper extension portion 303, see Figure 8 . The angle a between the center line of the downward extension 301 of the first anchor hook 310 and the axis of the valve stent is 25-50°; the angle β between the center line of the downward extension 301 of the second anchor hook 320 and the axis of the valve stent is is 25-35°; the angle γ between the center line of the downward extension 301 of the third anchor hook 330 and the axis of the valve stent is 20-35°.

In some embodiments, the design idea for the number and position of multiple anchor hooks is as follows: taking the vertical projection of the inner valve frame as a circle as an example for illustration. Divide the circle evenly. In an embodiment where the number of anchor hooks is 8, the angle is 45 degrees. See Figure 9. The angle between the projected extension lines of each anchor hook is 45 degrees. The three first anchor hooks 310 are located on the structure corresponding to the first curve segment C1 for hooking the partition leaves. The three second anchor hooks 320 are located on the structure corresponding to the second curve segment C2 and are used to hook the rear leaf. The two third anchoring hooks 330 are located on the structure corresponding to the third curve segment C3 and are used to hook the anterior leaflet to increase the fixation with the native valve leaflet and chordae tendineae. There is no anchor hook between the third anchor hook 330 and the first anchor hook 310 to prevent the anchor hook from hooking onto the ventricular wall.

The top ends of the first anchor hook 310, the second anchor hook 320 and the third anchor hook 330 are flush with the horizontal interface F on the outer support, and the lowest bottom end of the first anchor hook 310 is lower than the second anchor hook 320 and the third anchor hook 320. The lowest bottom end of the three anchor hooks 330. Figure 8 shows a structural comparison diagram of three anchor hooks. It can be seen from the figure that compared with the first anchor hook 310 and the second anchor hook 320, the longitudinal distance of the third anchor hook 330 is longer because the native anterior leaflet is longer. , this design can hook the front leaf better.

The tricuspid annulus (TA) is normally an asymmetric saddle-shaped ellipsoid with 2 distinct segments: a larger C-shaped segment corresponding to the free walls of the right atrium and right ventricle; and a shorter , the relatively straight part, corresponding to the septal leaves and interventricular septum. The anchoring hooks of different lengths used in this application can better adapt to the native part to be anchored. Due to the improved adaptability, the anchoring assembly in this application can achieve firm anchoring of the valve stent.

In some embodiments, the anchoring component is fixed on the outer bracket, as shown in FIG. 10 . When the anchoring component is fixed on the outer bracket, the number and position design of the multiple anchor hooks are consistent with the above-mentioned design idea of fixing the anchoring component on the inner bracket, and will not be described again here.

The anchoring component is connected to the outer stent, which is beneficial to reducing the deformation of the inner stent due to the anchor hook being driven by the native leaflets, and the angle adjustment of each anchor hook is more flexible.

Connection of inner and outer brackets

The inner bracket is a cylindrical structure with openings at both ends, and the top of the cylindrical structure is provided with an anchor point for connecting with the outer bracket. In some embodiments, as shown in FIG. 6 , the anchor point 210 is a ring-shaped structure with a hole in the middle.

In some embodiments, the bumps of the outer stent are annular structures with holes in the middle. See Figures 3 and 5 . The bumps 140 are located at the top of the outer stent.

The outer stent is sleeved on the outside of the inner stent, and the connection method between the protruding points on the inner stent and the anchor points on the outer stent includes one or more combinations of welding, riveting, crimping, and suture connection.

In one embodiment, the layer bracket and the outer layer bracket can also be tied and connected through flexible binding tapes (such as metal or non-metallic wires).

The support profile perimeter of the inner stent is not less than one-half of the support profile perimeter of the outer stent.

In some embodiments, acupuncture is provided on the surface of the anchoring hook that is bent toward the outer surface of the outer stent, and the needle punctures are directed toward the outer stent.

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, for example, it can be 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. The reason is that the outer stent is in contact with the native valve annulus. If the bottom end of the outer stent is too high, it will interfere with the valve stent. In the embodiment where the inner bracket is connected to the anchor component, the anchor hook needs to extend from the bottom end of the inner bracket to the outside of the outer bracket, so the lowest end of the outer bracket should not be lower than the lowest end of the inner bracket. .

Needling and developing points

In some embodiments, the surface of the anchor hook and the connection part with the outer stent are also provided with a coating layer, and the coating layer can be provided in the form of coating, woven fabric stitching, etc.

Optionally, the material of the coating layer can be materials with good biocompatibility and easy endothelialization such as PET, PTFE, ePTFE, PU, or biological tissue materials such as porcine pericardium and bovine pericardium.

In some embodiments, the outer stent is provided with acupuncture, as shown in Figure 5 or Figure 9. The acupuncture is used for pinning and fixing, and can more stably fix the valve stent or the prosthesis prepared by the stent.

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

In some embodiments, the anchor hook is provided with a development point.

valve prosthesis

Another aspect of the present invention provides a valve prosthesis, which includes a valve stent, a suture membrane, and a valve leaflet. The suture membrane surrounds the valve stent to form a sealing structure.

In some embodiments, the material of the suture membrane can be PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), ePTFE (expanded polytetrafluoroethylene), PU (polyamide) Materials with good biocompatibility and easy endothelialization, or biological tissue materials such as porcine pericardium and bovine pericardium.

Under the condition that it can block the flow of blood flowing through the valve prosthesis from the side wall of the outer stent, the suture membrane can be a mesh with dense mesh gaps made of yarns such as PET, PTFE, ePTFE, PU, etc. shape.

Optionally, the suture membrane can be connected to the lateral wall or medial wall of the outer stent, for example, through non-metallic wire binding.

In some embodiments, the leaflets are fixedly connected to a suture membrane wrapped around the side wall of the inner stent.

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

The valve prosthesis includes two artificial valve leaflets or three artificial valve leaflets. One end of the valve leaflets is stably connected to the suture membrane on the side wall of the inner stent, and the other end of the valve leaflets is the free end. In working condition, the artificial valve leaflets replace the native valve leaflets to realize the function of opening and closing the blood channel.

The leaflet assembly is made of materials including biological tissue materials or synthetic materials. For example, the biological tissue material can be any one of bovine pericardium, sheep pericardium, porcine pericardium or horse pericardium tissue, and the synthetic material can be polyurethane, polytetrafluoroethylene or Materials such as silicone polyester.

The valve prosthesis has two forms: a compressed state and an expanded state. Unless otherwise emphasized in the present invention, the characteristics are described in the expanded state.

use

The present invention provides the use of the aforementioned valve stent or the aforementioned valve prosthesis for preparing medical devices.

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

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

Example 1

This embodiment provides a valve stent, which includes an outer stent 100 , an inner stent 200 and an anchoring component 300 . As shown in Figure 1-3, the inner bracket 200 is placed inside the outer bracket 100 and maintains a predetermined gap with the outer bracket 100; the inner bracket 200 is used to construct a cylindrical flow channel; the top of the inner bracket 200 Connected to the top of the outer bracket 100 . Anchor assembly 300 includes a plurality of anchor hooks. A plurality of anchor hooks are installed at the bottom of the inner bracket 200 . Each anchor hook has a different bending angle and length. The tail end of each anchor hook is in contact with the outer contour surface of the outer bracket 100 .

The outer stent 100 includes a tapered portion 110, a supporting portion 120 and a stent portion 130 that are sequentially arranged along the axial direction of the valve stent. The tapered portion 110 is tapered from the top of the supporting portion 120 toward the axial direction of the valve stent. The support part 120 and the bracket part 130 meet at the 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, and the bracket portion 130 includes a plurality of V-shaped structures in a circumferential array. The V-shaped structure and the W-shaped structure Corresponding to the number of Y-shaped structures, the two top ends of each V-shaped structure are integrally formed with the two bottom ends of the corresponding W-shaped structure; the two bottom ends of the Y-shaped structure are connected to the two top ends of the W-shaped structure , the Y-shaped structure gradually shrinks toward the axial direction of the valve stent, and is provided with a convex point connected to the inner stent 200 at its top. The bumps are used to connect with the top of the inner bracket 200 .

The inner bracket 200 has a cylindrical structure with openings at both ends, as shown in FIG. 6 , and has a bell-shaped structure at both ends. The vertically projected outer contour of the inner bracket 200 is circular. The main body of the inner bracket 200 is provided with multiple hollows, which may be circular, grid-shaped, diamond-shaped or other patterns.

It can be understood that the distance between the outer stent 100 and the inner stent 200 can be adjusted by the diameter of the inner stent 200 . The smaller the diameter of the inner stent 200 , the smaller the distance between the outer stent 100 and the inner stent 200 . big.

Since the placement position of the valve stent or the manufactured prosthesis at the valve annulus, the shapes of the inner stent 200 and the outer stent 100, and the connection relationship between the two have a greater impact on the performance of the valve stent, the present invention has a greater impact on the inner stent 200 and outer stent 100. The selection of the distance and structural settings between the stent 200 and the outer stent 100 is also important. In the embodiment of the present invention, the support profile perimeter of the inner stent 200 is not less than half of the support profile perimeter 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, for example, it can be 1:2-4:5 or 3:5-4:5. . If the distance between the outer stent 100 and the inner stent 200 is too small, the radial support of the valve stent will be unstable, and the native valve annulus will squeeze the inner stent 200 after implantation, affecting the normal operation of the valve leaflets.

The forming methods of the inner bracket 200 and the outer bracket 100 include but are not limited to laser cutting, shearing and wire cutting. Compared with the single-layer valve stent, the double-layer stent has better stability. When the outer stent 100 is squeezed by the beating of the heart, the inner stent 200 is prevented from being affected, maintaining the normal opening and closing functions of the valve leaflets, and achieving better results. treatment effect.

A plurality of anchor hooks in the anchor assembly 300 are installed at the bottom of the inner bracket 200 , and each anchor hook is integrally formed with the inner bracket 200 . Referring to FIG. 7 , the vertically projected outer contour 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 anchor hook vertically projected within the first curve segment C1 is the first anchor hook 310; the anchor hook vertically projected within the second curve segment C2 is the second anchor hook 320; the vertical projection located within the second curve segment C2 The anchor hook is the third anchor hook 330 . The first anchoring hook 310 is disposed in the middle of the native anterior leaflet and the posterior leaflet, and is used to hook with the native valve leaflet and chordae tendineae. The second anchoring hook 320 is disposed at a position between the native posterior leaflet and the septal leaflet, and is used to hook the posterior leaflet; the third anchoring hook 330 is used to be disposed at a corresponding position between the anterior leaflet and the septal leaflet of the native tissue, and is used to Hooked with the front leaf.

Referring to Figures 3 and 6, the tops of the first anchor hook 310, the second anchor hook 320 and the third anchor hook 330 are flush with the horizontal interface F on the outer frame body, and the lowest bottom end of the first anchor hook 310 is lower than at the lowest bottom ends of the second anchor hook 320 and the third anchor hook 330 .

In some embodiments, the lateral projected height of the outer stent 100 is 28-33 mm. The number of the first anchor hooks 310 is three, and the lateral projection height is 10-17 mm; the angle a between the downward extension 301 of the first anchor hook 310 and the axis of the valve stent is 25-50°. The number of the second anchor hooks 320 is three, the lateral projection height is 8-14 mm, and the angle β between the downward extension 301 of the second anchor hook 320 and the axis of the valve stent is 25-35°. The number of the third anchor hooks 330 is three, the lateral projection height is 8-14 mm, and the angle γ between the downward extension 301 of the third anchor hook 330 and the axis of the valve stent is 20-35°. Compared with the first anchor hook 310 and the second anchor hook 320, the longitudinal distance of the third anchor hook 330 is longer because the native front leaf is longer, and this design can hook the front leaf better. The height and angle of the first anchor hook 310 and the second anchor hook 320 are also designed according to the size of the native valve annulus and surrounding native tissue. Therefore, the anchoring component 300 in this application is at the position where the valve prosthesis is implanted into the native valve annulus. The valve stent can be firmly anchored.

Example 2

This embodiment provides a valve stent, which includes an outer stent 100 , an inner stent 200 and an anchoring component 300 . The structure and connection method of the outer stent 100 and the inner stent 200 in this embodiment can be the same as the structure and connection method of the outer stent 100 and the inner stent 200 in Embodiment 1, except that the position of the anchoring component 300 is different.

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

In some embodiments, the lateral projected height of the outer stent 100 is 28-33 mm. The number of the first anchor hooks 310 is three, and the lateral projection height is 10-17 mm; the angle a between the center line of the downward extension 301 of the first anchor hook 310 and the axis of the valve stent is 25-50°. The number of the second anchor hooks 320 is three, the lateral projection height is 8-14 mm, and the angle β between the downward extension 301 of the second anchor hook 320 and the axis of the valve stent is 25-35°. The number of the third anchor hooks 330 is 2, the lateral projection height is 8-14 mm, and the angle γ between the downward extension 301 of the third anchor hook 330 and the axis of the valve stent is 20-35°. Compared with the first anchor hook 310 and the second anchor hook 320, the longitudinal distance of the third anchor hook 330 is longer, so that the third anchor hook 330 can better hook the front leaf. The height and angle of the first anchor hook 310 and the second anchor hook 320 are also designed according to the size of the native valve annulus and surrounding native tissue. Therefore, the anchoring component 300 in this embodiment is at the position where the valve prosthesis is implanted into the native valve annulus. The valve stent can be firmly anchored at all times.

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

Example 3

This embodiment provides a valve prosthesis that can be used to replace the tricuspid valve of the human body.

The difference between this embodiment and Embodiments 1 and 2 is that, as shown in Figures 11 and 12, the valve prosthesis also includes a suture membrane 400 and a valve leaflet assembly 500. 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 on the suture membrane 400 wrapped at the side wall of the inner stent 200 .

The suture membrane 400 can be made of PET, PTFE, ePTFE, PU and other materials with good biocompatibility and easy endothelialization, or biological tissue materials such as porcine pericardium and bovine pericardium.

The valve leaflet assembly 500 includes three artificial valve leaflets. One end of the valve leaflet is stably connected to the suture membrane 400 on the inner stent 200, and the other end of the valve leaflet is a free end. In the working state, the artificial valve leaflets replace the native valve leaflets 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 close to the side walls of the inner stent 200, allowing blood to pass through the inner side of the inner stent 200; when the leaflet assembly 500 is in the closed state, all leaflets The free end is away from the suture membrane 400 on the side wall of the inner stent 200, and the free ends on the two adjacent leaflets at least partially overlap.

When the valve prosthesis is implanted into the human body through the delivery system, the prosthesis is bundled in the delivery system at the implantation position in the human body, see Figure 13. The valve prosthesis automatically expands after release or is expanded by balloon pressure, and is limited on the tricuspid valve annulus 600 so that the long axis tip of the outer stent 100 is located between the anterior leaflet and the septal leaflet. The first anchoring hook 310 needs to hook the native tendineae, the second anchoring hook 320 and the surface of the outer stent 100 are located on both sides of the native valve leaflet and can be clamped on the posterior leaflet through the distance between them, and the third anchoring hook The surfaces of 330 and the outer stent 100 are located on both sides of the native valve leaflet and can be clamped on the anterior leaflet through the distance between them.

The maximum support contour of the outer stent 100 is slightly larger than the human valve annulus (can be 1.1-1.2 times the valve annulus contour). When implanted in the human valve annulus, the outer stent 100 is stuck in the human body's tricuspid valve annulus 600 position, so that the valve stent and the human valve annulus have a moderate interference fit to limit the position of the valve prosthesis at the valve annulus and avoid paravalvular leakage.

This design does less harm to the patient's native tissue while maintaining good radial support effect, while maintaining the overall stability of the valve prosthesis.

Obviously, many modifications and variations are possible in light of the contents of this specification. These embodiments are selected and described in detail in this specification to better explain the principles and practical applications of the present invention, so that those skilled in the art can make good use of the present invention. The invention is limited only by the claims and their full scope and equivalents.

Claims (19)

1. A valve stent, characterized in that it includes: The outer stent has an elliptical or elliptical-like outer contour in vertical projection; The inner bracket is placed in the outer bracket and maintains a predetermined gap with the outer bracket; the inner bracket is used to construct a cylindrical flow channel; the top of the inner bracket is in contact with the outer bracket. The top of the layer bracket is removable; An anchor assembly includes a plurality of anchor hooks. The plurality of anchor hooks are installed at the bottom of the outer bracket or the bottom of the inner bracket. The plurality of anchor hooks have different bending angles and lengths. The tail end of each anchor hook Contact with the outer surface of the outer bracket. 2. The valve stent according to claim 1, characterized in that the vertically projected outer contour of the outer stent is divided into a plurality of curved segments, and the vertical projection falls into the bending angle of the anchoring hook of the same curved segment. Same as length. 3. The valve stent according to claim 2, wherein the vertical projection of the inner stent is circular or annular; the vertical projection extension line of the anchor hook in the anchor assembly intersects with the circular shape. or the center of a donut shape and equally divides said circle or donut shape. 4. The valve stent according to claim 1, wherein the vertical projection of the inner stent is oval or elliptical-like; the vertical projection of the inner stent is the same as the vertical projection of the outer stent. Projections are concentric and parallel. 5. The valve stent according to claim 1, wherein the outer stent includes a tapered portion, a supporting portion and a stent portion arranged sequentially along the axial direction of the valve stent; the tapered portion extends from the supporting portion. The top of the valve stent gradually shrinks toward the axial direction of the valve stent; the interface between the support part and the stent part is a horizontal interface; The tail end of the anchor hook in the anchor assembly is aligned with the horizontal interface. 6. The valve stent according to claim 5, wherein the oval or elliptical-like outline is divided into a first curve segment, a second curve segment and a third curve segment; The first curve segment includes the tip of the major axis of an elliptical or elliptical profile, and the frame body of the outer stent whose vertical projection is the first curve segment is configured in the partition area; the vertical projection is the second curve The frame body of the segment is arranged in the posterior leaf area; the frame body of the vertically projected third curve segment is arranged in the front leaf area. 7. The valve stent according to claim 6, wherein the number of anchor hooks is 6-9, and the anchor hooks corresponding to the first curve segment, the second curve segment and the third curve segment are The number is 2-3. 8. The valve stent according to claim 6, characterized in that the anchor hooks located in the first curve segment in vertical projection are the first anchor hooks; the anchor hooks located in the second curve segment in vertical projection are the second anchors. hook; the anchor hook whose vertical projection is located within the third curve segment is the third anchor hook; The lateral projection height of the valve stent is 28-33mm; the lateral projection height of the first anchor hook is 10-17mm; the lateral projection height of the second anchor hook is 8-14mm; the lateral projection height of the third anchor hook Height is 8-14mm. 9. The valve stent according to claim 8, wherein the anchor hook includes a downward extension, a bending part and an upward extension; The angle between the center line of the downward extension of the first anchor hook and the axis of the valve stent is 20-35°; the angle between the center line of the downward extension of the second anchor hook and the axis of the valve stent is 25-35°. °; The angle between the center line of the lower extension of the third anchor hook and the axis of the valve stent is 25-50°. 10. The valve stent according to claim 6, wherein the stent portion includes a plurality of V-shaped structures in a circumferential array, the support portion includes a plurality of W-shaped structures in a circumferential array, and the tapered The portion includes a plurality of Y-shaped structures in a circumferential array; The numbers of V-shaped structures, W-shaped structures and Y-shaped structures correspond one to one. The two top ends of each V-shaped structure are fixedly connected to the two bottom ends of the corresponding W-shaped structure; the two bottom ends of the Y-shaped structure are connected to the W-shaped structure. The two top ends of the Y-shaped structure are connected, the Y-shaped structure gradually shrinks toward the axial direction of the valve stent, and a protruding point connected to the inner layer stent is provided on its top end. 11. The valve stent according to 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 according to claim 10, wherein the inner stent is a cylindrical structure with both ends open, and the top of the cylindrical structure is provided with an anchor point for connecting to the bump. 13. The valve stent according to claim 12, wherein the connection method between the protruding point and the anchor point includes one or more combinations of welding, riveting, crimping, and suture connection. 14. The valve stent according to claim 1, wherein the outer stent is provided with acupuncture, one end of the acupuncture is connected to the outer surface of the outer stent, and the other end is inclined toward the outside of the valve stent. 15. The valve stent according to claim 1, wherein the anchoring hook is provided with acupuncture on a surface bent toward the outer surface of the outer stent, and the acupuncture is directed toward the outer stent. 16. The valve stent according to claim 1, wherein 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 inner stent. the lowest end. 17. The valve stent according to any one of claims 1 to 16, wherein the maximum support profile of the outer stent is 1.1-1.2 times the native valve annulus profile. 18. The valve stent according to claim 17, wherein the ratio of the support profile circumference of the inner stent to the support profile circumference of the outer stent is 1:2-3:5. 19. A valve prosthesis, characterized by comprising the valve stent according to any one of claims 1 to 18, and a suture membrane and a valve leaflet, the suture membrane surrounding the outer stent and the inner stent. To form a sealing structure; the leaflets are fixedly connected to the suture membrane at the side wall of the inner stent.