CN100584292C - Artificial heart stent valve - Google Patents

Abstract

The invention provides an artificial heart stent valve. The stent-valve includes a tubular mesh stent, valve leaflets, a sealing membrane, radiopaque markers and a flexible coupling ring. The middle section of the mesh stent can be in the shape of a round tube or a drum, or be provided with a radially protruding structure, or be provided with an outer annular structure, or be provided with an outer free tongue, or be provided with a radially protruding structure plus an outer ring structure. Layer free tongue. The shape, structure and function of the stent valve of the present invention are more optimized; it can be radially compressed and accurately transported in place with the help of an interventional device, and then expanded. After expansion, the artificial stent valve conforms to the shape of the blood vessel wall in the radial and axial directions, without Paravalvular leakage: After implantation, it can play the role of a normal valve, which can prevent the artificial valve from slipping due to reverse blood flow when the valve is closed.

Description

Artificial heart stent valve

technical field

The invention relates to a substitute for human tissue, in particular to an artificial heart stent valve.

Background technique

The heart is the most important organ of the human body. The heart is divided into two parts, the left and the right, and each part includes the atrium and the ventricle. The left and right atria and right and left ventricles are separated by the atrial and ventricular septum, respectively. There are four heart valves in the heart, namely the tricuspid valve, pulmonary valve, mitral valve and aortic valve. In the human blood circulation mechanism, the four heart valves play a vital role. The hypoxic blood from the systemic circulation mechanism enters the right atrium through the vena cava, and then enters the right ventricle through the tricuspid valve. The contraction of the right ventricle pushes the blood into the pulmonary circulation mechanism through the pulmonary valve, and the oxygen-saturated blood returns to the left atrium through the pulmonary vein, and then Through the mitral valve to the left ventricle, the left ventricle contracts to expel blood through the aortic valve into the aorta and return to the systemic circulation. There are left and right coronary artery openings under the aortic valve. The structure of the four heart valves ensures that the valves open when the blood flows in the forward direction and close when the blood flows in the opposite direction, preventing the heart from increasing the burden caused by the backflow of blood. However, due to various reasons, acquired damage or pathology of heart valves can be caused, such as rheumatism, atherosclerosis, etc. In addition, congenital heart disease such as tetralogy of Fallot can also cause pulmonary valve disease in the long term after surgery. After valvular disease, the valve function is gradually lost, such as valvular insufficiency leading to blood regurgitation, valvular stenosis leading to poor blood flow, or both insufficiency and stenosis, which will increase the burden on the heart and lead to heart failure. For the acquired damage or disease of the heart valve, the traditional treatment method is to open the chest, and after the heart stops beating, the heart is opened to perform surgical repair of the diseased valve or replace it with an artificial heart valve under the support of hypothermic extracorporeal circulation. The existing artificial heart valves are divided into two categories: metal mechanical valves and biological valves. Biological valves are made from processed animal materials such as bovine pericardium, bovine jugular valve, and porcine aortic valve. The above-mentioned open-heart surgery method has long operation time, high cost, large trauma, and high risk. After metal mechanical valve replacement, the patient needs long-term anticoagulant treatment, and the material life of the biological valve is limited, and reoperation is usually required.

In order to solve the above-mentioned problems of open-heart surgery for the treatment of heart valves, some people try not to perform open-heart surgery, but use percutaneous intervention to deliver artificial heart valves. The interventional artificial heart valve of prior art has two kinds:

1. Balloon-expandable

This balloon-expandable artificial heart valve is a biological valve. The intervention method is to respectively fix the biological valve on a plastically deformable stent, radially compress it on a balloon, and then reduce the diameter, deliver it percutaneously, and then give it to the patient. The balloon is pressurized to expand and fix the stent to reach the working state.

In 1989, Henning Rud ANDERSEN (Patent No. WO9117720) took the lead in carrying out porcine aortic valve transcatheter artificial heart valve replacement (document... European Heart Journal 1992 13, 704-708).

2000 Philippe BONHOEFFER (Patent No. EP 1057460) and Alain CRIBIER

(Patent No. EP0967939) performed the artificial heart valve replacement of the pulmonary valve and the aortic valve in the human body for the first time.

The disadvantages and problems of the balloon-expandable artificial valve are: its diameter is determined by the diameter of the balloon. If the diameter of the artificial valve is not selected at the beginning, or after some physiological changes, such as natural growth, pathological vascular expansion, etc., The caliber of the natural valve may increase, but the caliber of the artificial valve cannot be adaptively increased, and the artificial valve may loosen or slip off, so only secondary balloon re-expansion can be performed.

2. Self-expanding

This prosthetic valve features an elastically deformable stent that expands on its own after being radially compressed.

Marc BESSLER (Patent No. US5855601) and Jacques SEGUIN (Patent No. FR2826863, FR2828091) also designed transcatheter prosthetic heart valve replacement. The difference is that they used an elastically deformable stent that can expand by itself after radial compression.

The artificial heart valve of Philippe BONHOEFFER (patent No. EP1281375, US2003036791) utilizes an elastically deformable stent, and contacts are housed at the upstream end or the distal end of the stent, and are pressed in the two inner and outer sheath tubes.

The applicant once used a drum-shaped stent valve in the middle section, a self-expanding reinforced synthetic stent valve, and a bundled delivery device in the invention application of China Invention Patent Application No. 200410054347.0.

The disadvantages and problems of the self-expandable artificial heart valve are: the frictional force between the self-expandable artificial heart valve and the sheath tube is large, which affects the accurate release of the artificial valve.

The support wire of the bundled delivery device has a large friction force when passing through the deformable unit of the artificial valve, and the wire is easy to dislocate when not passing through.

The common shortcoming and the problem that above-mentioned balloon expansion type and self-expanding artificial heart valve exist are:

1. The delivery device of the existing interventional artificial stent valve and the stent valve under radial compression are relatively hard and poor in flexibility. It is not easy to pass through the aortic arch and cannot be aligned with the natural aortic valve orifice.

2. Even with the help of X-ray fluoroscopy, the axial upstream and downstream positioning of the interventional artificial stent valve and its delivery device becomes uncertain due to the inaccurate judgment of the anatomical position and the instability of the artificial valve under the impact of blood flow. easy. The interventional prosthetic aortic valve can affect the mitral valve if it is positioned upstream, and it can block the coronary artery opening if it is positioned downstream.

3. The rotation direction positioning of the interventional aortic valve artificial stent valve and its delivery device cannot be solved. The interventional prosthetic aortic valve can block the opening of the coronary artery if it is rotated incorrectly.

4. When the self-expanding artificial stent valve is highly compressed, the retraction of the sheath will encounter great resistance. The resistance and difficulty of withdrawing the sheath can also cause the operator to displace the fixed artificial stent valve.

5. During the release process, the stent valve gradually expands from half to full expansion, and the required time exceeds one heartbeat cycle. The expanded stent valve can obstruct blood flow, and the stent valve can also change its position due to the impact of blood flow. In particular, balloon-expandable prosthetic stent-valves completely block blood flow during balloon expansion.

6. If the patient has coronary artery bypass (Coronary Artery Bypass), the implanted artificial stent valve should not affect the blood perfusion of the bypass opening at the ascending aorta.

7. If the aortic valve self-expanding stent valve of Jacques SEGUIN and Philippe BONHOEFFER can be successfully implanted, although the perfusion of the coronary artery will not be affected immediately after the operation, the middle part of the stent will not stick to the vessel wall at the aortic root, so that the blood flow Flow through the stent mesh, on the one hand, may cause thrombus formation; on the other hand, it will affect or hinder possible future diagnosis and treatment of coronary artery intervention.

8. There are also the following problems in the fixation of the stent valve after release and expansion:

a) The impact of blood flow during systole and diastole will move the poorly fixed artificial stent valve.

b) Some patients with aortic valve insufficiency have pathological expansion of the aortic root before surgery, and need to

It takes a very large stent valve to anastomose and fix it.

c) Some patients will have local anatomical changes after artificial stent valve implantation, such as expansion, so that the

The stent valve that can change accordingly loses effective fixation.

9. The artificial stent valve after expansion and fixation has paravalvular leaks (Para valvular leaks) in many cases, that is, blood leaks between the stent valve and the vessel wall.

10. If the valve leaflet switch touches the metal bracket, the valve leaflet will be worn.

11. If a large-diameter stent valve is used for fixation, the commissure of the valve leaflets will bear a lot of stress, resulting in tearing of the commissure of the valve leaflets.

Contents of the invention

The purpose of the present invention is to overcome the above-mentioned problems that prior art exists, and a kind of artificial heart stent valve of novel structure is provided. It can be used for both interventional therapy and minimally invasive surgery.

The object of the present invention is achieved like this: a kind of artificial heart stent valve is characterized in that, comprises a tubular mesh support that can be radially deformed between expanded state and compressed state, and this mesh support comprises upstream section, middle section and the downstream section, a plurality of deformable units are formed or enclosed between the network wires of the mesh support, and a plurality of open wire bends are formed at both ends of the mesh support, and a sealed line eye separate from the deformable unit is provided. On the inner side of the middle section of the mesh stent, there are valve leaflets that can be switched on and off and allow blood to pass through in one direction. The junction of the valve leaflets and the mesh stent forms the leaflet joint line, and the joint line of the two adjacent valve leaflets intersects to form The leaflet juncture is covered with a sealing film on the inner and/or outer sides of the upstream section of the mesh stent and extends to the middle section, and a plurality of radiopaque signs and flexible coupling rings are arranged on the mesh stent.

In the aforementioned artificial heart stent valve, the mesh stent may be woven from elastic wires or cut from elastic tubes.

The above-mentioned artificial heart stent valve, wherein, the mesh stent is in the shape of a circular tube with the same size as a whole, and a stent opening is provided in the middle section of the circular tube-shaped mesh stent.

The above-mentioned artificial heart stent valve, wherein, the middle section of the mesh stent is in the shape of a drum protruding outward, and a bracket opening is provided in the middle of the drum-shaped middle section.

The above-mentioned artificial heart stent valve, wherein, the middle section of the mesh stent deforms at least one outwardly protruding radial protruding structure on the basis of a circular tube shape or a slight drum shape, and a center of each radial protruding structure is provided. There is a large stent opening, and the connection between the radially protruding structure and the mesh stent body forms a half-moon-shaped upstream periphery and a half-moon-shaped downstream periphery, and the half-moon-shaped upstream periphery forms a leaflet joint line connected with the valve leaflets.

In the above-mentioned artificial heart stent valve, there is one radially protruding structure in the middle section of the mesh stent.

The above-mentioned artificial heart stent valve, wherein, there are two radially protruding structures in the middle section of the mesh stent, and the two radially protruding structures are distributed at 90-180 degree rotation angles.

In the aforementioned artificial heart stent valve, there are three radially protruding structures in the middle section of the mesh stent, and the three radially protruding structures are evenly distributed along the radial direction.

The above-mentioned artificial heart stent valve, wherein, the upstream section of the mesh stent is trumpet-shaped, and the outer edge of the trumpet-shaped upstream section is provided with a wavy lip corresponding to the radially protruding structure of the middle section.

The above-mentioned artificial heart stent valve, wherein, the middle section of the mesh stent is a circular tube-shaped inner and outer double-layer structure, and an outer annular structure is connected to the stent body, and the outer annular structure and the inner layer are in the downstream section or The junction of the downstream section and the middle section is connected to form a fixed edge, and the outer annular structure ends at the junction of the upstream section and the middle section to form a free edge and can be provided with a sealed line eye to separate from the deformable unit.

The above-mentioned artificial heart stent valve, wherein, the middle section of the mesh stent has a circular tube shape or a slight drum shape as the inner layer, and at least one outer layer of the free tongue surrounded by a single mesh wire is connected to the outside. The free tongue and the inner support body are connected at the downstream section or the junction of the downstream section and the middle section to form a fixed edge, and extend from the fixed edge to the upstream section to form a free edge at the junction of the upstream section and the middle section. The front end of the free edge can be provided with Sealed eyelets, which can be covered with X-ray-opaque marks.

The above-mentioned artificial heart stent valve, wherein, there are three free tongues, and the three free tongues are allocated at a 120-degree turning angle and correspond to the valve leaflets.

The above-mentioned artificial heart stent valve, wherein, the middle section of the mesh stent deforms at least one outwardly protruding radial protruding structure on the basis of a circular tube shape or a slight drum shape, and each radial protruding structure is connected with a A free tongue enclosed by a single wire, the free edge of the free tongue and the periphery of the radially protruding structure are at least half-moon-shaped upstream periphery overlapping on two parallel curved surfaces.

The above-mentioned artificial heart stent valve, wherein, the valve leaflets can be made of biomaterials or synthetic materials, and at least one reinforcing fiber is arranged in the valve leaflets of synthetic materials, and the reinforcing fibers start and end at two of the same valve leaflets. Different joint points or joint lines, connected on the mesh support.

In the above-mentioned artificial heart stent valve, the reinforcing fibers are mainly arranged on the downstream surface of the valve leaflet, and may also be arranged on the free edge or closing edge of the valve leaflet.

The above-mentioned artificial heart stent valve, wherein, the valve leaflets are two to three, and the three valve leaflets are distributed at a 120-degree angle, and each valve leaflet includes a free edge and a closing edge, and a closing area is formed between the free edge and the closing edge .

The above-mentioned artificial heart stent valve, wherein, the sealing membrane can be made of biological material or synthetic material, and at least one reinforcing fiber is arranged in the sealing membrane of synthetic material, and the reinforcing fiber is arranged in a circular shape, and is connected with the mesh Linked or connected with brackets.

The above-mentioned artificial heart stent valve, wherein, the sealing membrane is provided with a sealing membrane eye communicating with the inside and outside at the sealing line eye of the mesh stent.

The above-mentioned artificial heart stent valve, wherein, the sealing membrane can extend upstream outside the mesh stent to form a soft membrane without stent support, and can extend downstream inside the mesh stent to the leaflet commissure line.

The above-mentioned artificial heart stent valve, wherein, the reinforcing fiber is selected from polyester fiber, polypropylene fiber, polyethylene fiber or carbon fiber.

The above-mentioned artificial heart stent valve, wherein the radio-opaque mark is a tubular point-shaped mark set on the mesh wire, and the tubular point-shaped mark is set at the valve leaflet joint point in the middle section of the mesh stent, and can also be set at The upstream section of the mesh support or the junction of the upstream section and the middle section or the downstream section.

The above-mentioned artificial heart stent valve, wherein, the radio-opaque mark is a linear mark connected head to tail, and the linear mark is adjacent to the joint line of the leaflets and interweaves on the mesh wire of the mesh stent.

The above-mentioned artificial heart stent valve, wherein, the flexible coupling ring is arranged at the open wire bends and the sealed wire eyes at both ends of the mesh stent and the middle part of the mesh stent.

The above-mentioned artificial heart stent valve, which also includes a sealing ring, which is arranged on the outside of the junction between the upstream section and the middle section of the mesh stent, and the sealing ring is a soft semi-open tubular structure, which can be circular Or the wave shape corresponding to the radially protruding structure is provided with a plurality of point-shaped openings facing the inner surface or the outer surface of the stent valve, or is provided with groove-shaped openings facing the inner surface of the stent valve.

In the aforementioned artificial heart stent valve, the sealing ring may be made of biological material or synthetic material.

Compared with the prior art, the artificial heart stent valve of the present invention has the following advantages and positive effects due to the adoption of the above-mentioned technical scheme:

1. The shape, structure and function of the artificial stent valve are more optimized.

2. The deformable stent can cooperate with biological valves or synthetic valves.

3. Increase the strength and lifespan of the synthetic valve, without anticoagulation, and it is expected to replace the biological valve.

4. Prevent the valve from contacting and rubbing against the metal stent when the valve is switched on and off, and prevent blood leakage around the valve.

5. The prosthetic stent valve can be radially compressed, accurately transported in place with the help of the interventional device, and then expanded. The prosthetic stent-valve does not accidentally separate from the delivery device before and during expansion. If it is found that the position of the artificial stent valve is not ideal during the expansion process, it can be corrected.

6. The friction force between the artificial stent valve and the sheath tube in the compressed state is low, which is conducive to the precise release of the artificial stent valve.

7. After expansion and release, the artificial stent valve conforms to the shape of the blood vessel wall in the radial direction and the axial direction.

8. The artificial stent valve can play the role of a normal valve after implantation.

9. After the artificial stent valve is implanted, it can prevent the artificial valve from slipping caused by blood in the opposite direction when the blood regurgitation valve is closed.

10. The expanded stent valve will not produce paravalvular leakage.

Description of drawings

Through the following description of multiple embodiments of the artificial heart stent valve of the present invention in conjunction with the accompanying drawings, the purpose, specific structural features and advantages of the present invention can be further understood. Among them, the attached figure is:

Fig. 1 is in the artificial heart stent valve of the present invention, the three-dimensional perspective view of the stent valve that the mesh stent is in the shape of a circular tube as a whole;

Fig. 1 a is the plane development view of the single-layer braided structure of the stent valve shown in Fig. 1;

Fig. 2 is in the artificial heart stent valve of the present invention, the three-dimensional perspective view of the stent valve that the middle section of mesh support is drum-shaped;

Fig. 3 is in the artificial heart stent valve of the present invention, the middle section of mesh support has the three-dimensional perspective view of the stent valve of radially protruding structure;

Fig. 3a is a front view of the stent-valve shown in Fig. 3 .

Figure 3b is a top view of Figure 3a;

Figure 3c is a bottom view of Figure 3a;

Figure 3d is a side view of Figure 3a;

Fig. 3e and Fig. 3f are cross-sectional schematic diagrams of Fig. 3b along the lateral axis bx;

Fig. 4 is in the artificial heart stent valve of the present invention, and the middle section of mesh support is the three-dimensional perspective view of the stent valve of circular tubular inner and outer double-layer structure;

Figure 4a is a planar expansion view of the double-layer braided structure of the stent valve shown in Figure 4;

Fig. 5 is in the artificial heart stent valve of the present invention, the three-dimensional perspective view of the stent valve with free tongue in the middle section of mesh support;

Fig. 5a is a plane development view of the double-layer braided structure of the stent valve shown in Fig. 5;

Figure 5b is a top view of the stent valve shown in Figure 5;

Fig. 6 is a three-dimensional perspective view of the stent valve of the artificial heart stent valve of the present invention, in which the middle section of the mesh stent has a radially protruding structure and a free tongue.

Detailed ways

Referring to Fig. 1, refer to Fig. 2, Fig. 3, Fig. 4, Fig. 5, Fig. 6, and Fig. 10a, Fig. 10b, Fig. 10c, Fig. 10d, Fig. 10e, Fig. 10f, the artificial heart stent valve 1 of the present invention comprises: Radially deformable self-expanding mesh stent 10, X-ray-opaque markers 311, 312, valve leaflets 33 that can be switched on and off and allow blood to pass through in one direction, sealing membranes 351, 354, sealing rings 37, reinforcing fibers in the synthetic membrane 39 and flexible coupling ring 41.

The valve leaflets 33, the sealing membranes 351, 354, and the sealing ring 37 can be made of biological materials or synthetic polymer materials. If it is made of biological materials, the valve leaflets 33, sealing membranes 351, 354 and sealing ring 37 are sutured on the stent 10; if it is made of synthetic polymer materials, the self-expanding stent valve 1 can form a seamless integrated whole, In this way, the strength of the stent valve 1 can be enhanced, and the gap between the valve leaflet 33 and the sealing membranes 351 and 354 can be smooth without sharp dead edges.

The radially deformable self-expanding mesh stent 10 is a central hollow tubular mesh structure made of elastic material, and the stent expands to an expanded state without external force constraints. Under the action of external force, the stent is radially compressed and is in a compressed state. No matter in the natural state or the expanded state, the self-expanding mesh stent 10 can be divided into three parts according to the outer contour: the downstream section 13 , the middle section 15 and the upstream section 18 .

The downstream segment 13 is the proximal end of the stent for the operator in the case of a reverse blood flow path with respect to the aortic valve. The present invention adopts the reverse blood flow path. In the case of blood flow, it is the distal end of the stent to the operator. The downstream segment 13 fits with the ascending aorta. The downstream section 13 is an orbiting profile structure with xx as the major axis. Under the natural state or expanded state, it can be two kinds of shapes, garden tube shape and trumpet shape. When the downstream section 13 is trumpet-shaped, the small mouth end is close to the junction zone 133 between the downstream section 13 and the middle section 15 , and the large mouth end is close to the downstream port 134 . The length of the downstream segment 13 can be varied as required, and is less than 50 mm of the length of the ascending aorta. The deformable unit 101 at the end of the downstream port 134 of the downstream section 13 may or may not be at one level. The deformable unit 101 at the end of the downstream port 134 of the downstream section 13 may have an open wire turn 102 leading to the deformable unit 101 , or may have a sealed wire eye 103 separated from the deformable unit 101 .

The middle section 15 is located in the middle of the self-expanding mesh stent 10 . The middle section 15 cooperates with the coronary sinus of the heel of the aorta and the leaflets of the aortic valve. Its length can be changed according to needs, between 15-30mm. The middle section 15 can be divided into three categories in the natural state or in the expanded state: 1. The pivoting contour structure with xx as the long axis: including the circular tubular structure 151 and the drum-shaped structure 152; 2. The long axis with xx The composite structure of the profile around the axis and the radially protruding profile with ax, bx, and cx as the lateral axes, the middle section 15 has a radially protruding structure 153; 3, the inner and outer double-layer structure: with the aforementioned two profile structures, including the circular tube shape The structure 151 , the drum-shaped structure 152 and the composite structure with the radially protruding structure 153 serve as the inner support body 154 . There is an outer structure outside the inner stent body 154 , including an outer annular structure 155 and a free tongue 156 . The inner layer 154 and the outer layers 155 and 156 are connected at the junction zone 133 of the downstream section 13 or the downstream section 13 and the middle section 15 . A certain deformable unit 101 of the middle section 15 may be separated from the deformable unit 101 by a sealed line eye 103 .

The middle section of the mesh support in the artificial heart stent valve 1 of the present invention can have following six structural forms:

Referring to Fig. 1, referring to Fig. 1a, Fig. 1 is the first structural form of the middle section, in this structure, the middle section 15 is a garden tubular shape 151 with xx as the major axis turning around the profile. There is support opening 158 in the middle part of garden tubular shape 151 .

Referring to Fig. 2, Fig. 2 is a second structural form of the middle section. In this structure, the middle section 15 is a drum-shaped 152 with xx as the major axis to rotate around the profile. The outer diameter of the middle part 157 of the drum 152 is the largest, which is larger than the outer diameter of the junction zone 133 between the downstream section 13 and the middle section 15 and larger than the outer diameter of the junction zone 183 between the upstream section 18 and the middle section 15 . The central portion 157 of the drum 152 has a bracket opening 158 .

Referring to Fig. 3, refer to Fig. 3a, Fig. 3b, Fig. 3c, Fig. 3d, Fig. 3e, Fig. 3f for coordination. Fig. 3 is the third structure form of the middle section. In this structure, the middle section 15 is a composite structure, with xx as the long axis of the garden tube 151, or a slight drum-shaped 152 around the axis, and the outer surface has ax, bx, cx as one or More than one radial protruding structure 153 extends radially outward. The ax, bx, cx lateral axes are perpendicular to the xx long axis. The three side axes of ax, bx, and cx are distributed at 120-degree rotation angles. The radial projections 153 distributed at 120° rotation angle are used to cooperate with the coronary sinus or native aortic valve leaflets. The radially protruding structure 153 is an integral part of the stent. The middle portion 157x of each radially protruding structure 153 has a large outer diameter, and a large bracket opening 158 is formed in the center. All peripheries 159i, 159o of each radially protruding structure 153 are connected to the pivoting profile support body. The outer diameter of the periphery 159i, 159o is smaller than that of the middle part 157x of the protruding structure. The periphery 159i, 159o is divided into two half-moon-shaped upstream periphery 159i and downstream periphery 159o, bounded by the joint point 160. The upstream perimeter 159i of the half-moon forms the leaflet commissure line 331 connecting the valve leaflets 33 . Two adjacent radially protruding structures 153 are connected at a joint point 160, and the joint point 160 overlaps and merges into one. The outer diameter of the joint point 160 is smaller than that of the middle part 157x of the protruding structure, forming the joint point of the leaflet joint point 332 . The radial protruding structure 153 is at least one leaf. 1-3 leaflets allocated for 120° turn at the aortic valve. FIG. 3 shows a mesh stent with three radially protruding structures 153 .

Referring to Fig. 4, see Fig. 4a for cooperation, Fig. 4 is the fourth structural form of the middle section. In this structure, the middle section 15 is a circular tube-shaped inner and outer double-layer structure, including an inner stent body 154 and an outer ring structure 155 . The inner stent body 154 and the outer annular structure 155 are connected at the downstream section 13 or the downstream section 13 with the junction zone 133 of the middle section 15 , which is called the fixed edge 161 . The outer annular structure 155 ends at the boundary zone 183 between the upstream section 18 and the middle section 15 , and is in a free or active state, called the free edge 162 . In a natural state or in an expanded state, the inner stent body 154 and the outer ring structure 155 are parallel to each other. When the inner stent body 154 is radially compressed, with the fixed edge 161 as the axis, the outer annular structure 155 can be radially compressed to approach the inner stent body 154, or expand away from the inner stent body 154 after removing the centripetal constraint force Opens to the upstream port 184 in a flared shape.

Referring to Fig. 5, refer to Fig. 5a and Fig. 5b for cooperation. Fig. 5 is the fifth structural form of the middle section. In this structure, the middle section 15 is a composite structure of inner and outer layers. The garden tubular shape 151 with xx as the major axis, or the inner layer support body 154 of the slight drum shape 152 around the axis, the outer surface has one or more single network cables with dx, ex, fx as the side axes The enclosed free tongue 156 starts from the downstream section 13 or the boundary zone 133 between the downstream section 13 and the middle section 15 and extends outward toward the upstream end 184 to the boundary zone 183 between the upstream section 18 and the middle section 15 . The dx, ex, fx lateral axes are perpendicular to the xx long axis. The three side axes of dx, ex, and fx are allocated at a 120-degree rotation angle. Three free tongues 156 assigned with 120-degree turning angles are used to cooperate with the coronary sinus or natural aortic valve leaflets. The free tongue 156 is an integral part of the bracket. A part of the periphery of the free tongue 156, such as the downstream periphery, is connected to the inner support body 154, which is called the fixed edge 163; The fixed edges 163 of two adjacent free tongues 156 meet at a joint point 165 . The joint point 165 and the leaflet joint point 332 are on the same rotation plane. When the inner stent body 154 is radially compressed, with the fixed edge 163 as the axis, the free tongue 156 can be radially compressed and close to the inner stent body 154, or expand away from the inner stent body 154 after removing the centripetal constraint force to form a trumpet shape Opens to upstream port 184 .

Referring to Fig. 6, Fig. 6 is the sixth structural form of the middle section. In this structure, the middle section 15 is the radial protruding structure 153 of FIG. 3 and the free tongue 156 of FIG. 5 is added. The radial protruding structure 153 and the free tongue 156 exist simultaneously at the same angular position. The free edge 164 of the free tongue 156 overlaps the peripheries 159i, 159o of the radially protruding structure 153, at least the upstream peripheries 159i of the half-moon shape, on two parallel curved surfaces.

Continuing to refer to FIGS. 1 to 6 , the upstream section 18 is the other end opposite to the downstream section 13 . The upstream segment 18 fits the aortic valve annulus. As far as the aortic valve is concerned, it is the distal end of the stent for the operator during the reverse blood flow operation. The present invention adopts the reverse blood flow path. When operating along the blood flow path, it is the proximal end of the stent for the operator. The upstream section 18 is an orbiting profile with xx as the major axis. Under the natural state or the expanded state, it can be in two structural shapes: a garden tubular shape 181 (see FIGS. 1 and 5 ) and a trumpet shape 182 (see FIGS. 2 , 3 , 4 , and 6 ). The garden pipe shape 181 is the extension of the middle section 15 to the upstream port 184 in the garden pipe shape. The trumpet shape 182 is that the middle section 15 extends toward the opening of the upstream port 184 in a trumpet shape. The trumpet-shaped 182 has a small diameter close to the middle section 15, and a large diameter is the upstream port 184. The diameter of the upstream port 184 of the trumpet shape 182 is much larger than the diameter of the junction zone 183 between the upstream section 18 and the middle section 15 . The length of the upstream segment 18 can be varied as required, and is generally less than 20 mm so as not to interfere with the mitral valve. Regardless of whether the upstream section 18 is in the form of a garden tube 181 or a trumpet 182, the deformable unit 101 at the end of the upstream port 184 of the upstream section 18 can be at a level, and the upstream port 184 is a flat opening. The deformable unit 101 at the end of the upstream port 184 of the upstream section 18 may not be at the same level. For example: with three hemispherical radially protruding structures 153 existing simultaneously, the upstream port 184 of the upstream section 18 of the trumpet-shaped 182 is not at the same level. The upstream section 18 of the trumpet 182 is relatively short at the joint point 160 of the radially protruding structure or the joint point 332 of the leaflets, and the upstream section 18 of the trumpet 182 is relatively long at the position opposite to the middle part 157x of the radially protruding structure 153, resulting in the upstream section of the trumpet 182 The upstream port 184 of 18 is a three-lobed wave-shaped mouth 185 corresponding to the three radially protruding structures 153 . The deformable unit 101 at the end of the upstream port 184 of the upstream segment 18 may have an open wire turn 102 leading to the deformable unit 101 , or may have a sealed wire eye 103 separated from the deformable unit 101 .

The present invention adopts a radially deformable self-expanding mesh stent 10 . The above-mentioned outer contour is the natural state or expanded state of the self-expanding mesh stent 10 . The self-expanding mesh stent 10 is made of elastic material. Known biocompatible elastic materials include nickel-titanium shape memory alloy Nitinol, cobalt-chromium alloy Phynox, L605, and others. It is difficult for the above-mentioned outer contour mesh stent to be a balloon-expandable stent made of plastic material. Because these outer contours need to be expanded with a specific shape of the balloon to achieve. The self-expanding mesh stent 10 with the above outer contour can be woven from elastic wires, or can be cut from elastic tubes.

The self-expanding braided mesh stent 10 can be implemented by the following methods:

The basic weaving method of the self-expanding braided mesh stent 10 is as follows:

Referring to Fig. 1a, Fig. 4a, Fig. 5a, refer to Fig. 1 to Fig. 6 and Fig. 10a, Fig. 10b, Fig. 10c, Fig. 10d, Fig. 10e, Fig. The elastic braided wire 104 is braided. A certain point in the two end points 105, 106 of the single line 104, such as the starting point 105, starts along the aforementioned specific outer contour 151 or 152 or 153 or 154 or 155 or 156, 181 or 182 and advances spirally until the end of the stent 134, 184 Folding in the opposite direction of symmetry along a specific outer contour 151 or 152 or 153 or 154 or 155 or 156, 181 or 182 helical progress. This is repeated until all the deformable units 101 are established, and ends when one of the two end points 105 , 106 such as the end point 106 reaches or exceeds the start point 105 . The same single line 104 forms an up and down intersection point 107 when the folded two-segment lines 104' intersect. The up-down relationship between one intersecting point 107 and the four nearest intersecting points 107' is just opposite. A deformable unit 101 is a quadrilateral or rhombus structure, which is composed of four sides 104' of the same single line 104 folded and four intersecting points 107, 107'. The four-sided deformable units 101 or the stent braided by the four-sided deformable units 101 are radially compressed and deformed, mixed with axial elongated deformation. The single braided wire 104 goes to the end of the stent, such as after the upstream port 184 and the downstream port 134, or to the end of a deformable unit 101, and then folds to the symmetrical opposite direction to form an open wire bend 102 less than 360 degrees. If the braided wire 104 of the open wire turn 102 is turned 360 degrees again, the sealed wire eye 103 can be formed. The sealed wire eye 103 can be at both ends of the bracket, such as the upstream port 184 and the downstream port 134, or it can be between the two. There may be one or more sealed eyelets 103 on each segment. The sealed wire eye 103 can be on the same outer contour curved surface or tangent plane with the bracket, or can be inward or outward on a plane (diameter plane) perpendicular to the bracket, or can be in between. The end of the bracket, such as the open wire lug 102 of the upstream port 184 and the downstream port 134, the sealed wire eye 103 can be at the same level or at different levels. For a three-valve leaflet stent valve, the number of deformable units along the perimeter is a multiple of three, which is beneficial to the symmetry of the three valve leaflets. The number of deformable units along the perimeter of the stent 10 braided by a single braided wire 104 divided by the number of deformable units along the long axis should be a fraction rather than an integer. The end point 106 in the single braided line 104 arrives at the starting point 105 and can be repeated at the same position after braiding a stent, including: 1. All repeats at all positions, so that the radial strength of the two-segment line or above the two-segment line is formed Higher stent; 2. In the local area, such as the upstream section, the middle section or the downstream section, the local radial elastic force is enhanced after repeating the two-segment line or above the two-segment line. Two-segment lines to multi-segment lines can approach or overlap to form deformable units 101 of different sizes, including larger openings 158 . Stents woven from a single wire can also be woven from multiple wires. Two or more same or different single threads can be braided together at the same time. Each single line constitutes a bracket. However, two or more stents overlap to form a combined stent. Different single lines can have different thicknesses. Different single wires, materials can be different. For example, one line can be a single line of radiopaque material, such as gold, tungsten, platinum, tantalum, etc.

The specific weaving method of the above-mentioned several structures of the mesh support in the artificial heart stent valve 1 of the present invention is introduced below:

The middle section adopts the weaving method of the first structure:

Take xx as the garden tubular shape 151,181 of major axis and turn the braiding method of contour support with basic braiding method around the axis.

The middle section adopts the weaving method of the second structure:

Downstream section 13 is the garden tubular shape with xx as major axis, and middle section 15 is drum type or garden spherical 152, and upstream section 18 is the same basic braiding method that the braiding method of turning the profile support around the axis of trumpet-shaped 182. The length of each braided wire 104' from the upstream port 184 to the downstream port 134 of the stent is the same.

The middle section adopts the braiding method of the third structure:

On the basis of braiding method 2, take xx as the garden tubular shape 151 of major axis, or slight drum shape or garden spherical shape 152 turns around the profile, and middle section 15 outer surface has with ax, bx, cx one or More than one radially protruding structure 153 extends radially outwardly to support the composite structure. The weaving method for this contour support is similar to the basic weaving method. The stent whose middle section 15 is a radially protruding structure 153 can be braided by a single braided wire 104 . The stent braided by a single braided wire 104 passes through different parts of the three hemispherical radially protruding structures 153 from the downstream port 134, such as the middle part 157x or the joint point 160, to the junction zone 183 between the upstream section 18 and the middle section 15, and stops at each section of the braided wire The lengths are not the same, and the adjacent deformable units are not equal in length. However, the sliding between adjacent sections of the braided wires at the intersecting points 107, 107' of the braided stent ensures that the stent and the radially protruding structure 153 can be radially compressed and radially expanded. There are three hemispherical radial protruding structures 153 at the same time, and the upstream section 18 of the trumpet-shaped 182 is relatively short at the joint point 160 of the radial protruding structure or the joint point 332 of the leaflets, and the upstream section 18 of the trumpet-shaped 182 is connected to the radial protruding structure 153 The central portion 157x is comparatively longer so that the upstream section 18 of the trumpet 182 is a three-lobed undulating mouth 185 opposite the three radially protruding structures. The braided wire at the longer part of the upstream section 18 of the trumpet-shaped 182 passes through the joint point 160 of the adjacent radially protruding structure or the smaller outer diameter of the leaflet joint point 332, and the braided wire at the shorter part of the upstream section 18 of the trumpet-shaped 182 passes through the middle part 157x of the radially protruding structure Larger outer diameter. In this way, the length of each segment of the braided wire between the upstream port 184 passing through the three radially protruding structures 153 and the downstream port 134 can be the same. Each segment line is equal in length under expansion state and under compression state. In the expanded state, the upstream port 184 of the stent has three wavy sides 185 corresponding to the three radially protruding structures 153 . When radially compressed and axially extended, the adjacent segments at the intersection point slide, the three radially protruding structures 153 and the three wavy sides 185 disappear, and the deformable units of the upstream port 184 are parallel. The single wire 104 can not only be woven into a single-layer reticular shell support 10, but also can be woven into a multi-layer three-dimensional structure support.

The middle section adopts the braiding method of the fourth structure:

After the single wire 104 is braided into a single-layer reticular shell stent 10, another section 104' of the same braided single wire 104 is locally repeated in situ at the downstream section 13 of the bracket. To the middle section 15, the single wire 104 stretches out and breaks away from the braided inner layer stent body 154 and braids the outer layer ring structure 155 separately. The middle section 15 single line 104 of the outer ring structure 155 is compiled and then returned to the downstream section 13 of the bracket body to repeat in situ, so that the downstream section bracket body 13 and the middle section 15 outer ring structure 155 repeat back and forth and rotate the bracket Turn about 360 degrees until the outer ring structure 155 as shown in FIG. 4a is formed. There are inner and outer two-layer supports 154,155 in the middle section like this. The two layers are connected as a fixed edge 161 between the middle and downstream sections. The outer annular structure 155 extends outwardly from the junction zone 133 of the downstream section 13 and the middle section 15 to the upstream port 184 to the level of the junction strip 183 between the middle section 15 and the upstream section 18 . The radial compression of these outer annular structures 155 facilitates delivery. Under the radial compression of the inner stent body 154, with the fixed edge 161 as the axis, the outer annular structure 155 can be radially compressed independently of the inner stent body 154 and close to the inner stent body 154 or after the centripetal restriction force is removed. The release expands away from the inner stent body 154 in a bell mouth shape. Independent of the compressed or expanded state of the inner stent body 154, these outer ring structures 155 expand independently to perform positioning and fixation. In the expanded state of the inner stent body 154 and the outer annular structure 155, these outer annular structures 155 can be flatly attached to the outer surface of the inner stent body 154, or can be trumpet-shaped and extend toward the upstream port 184 on the outer surface of the stent body. . The ratio of the number of perimeter cells CN' to the number of axial cells LN' in the repeated part of the double-segment line in the downstream section 13 of the stent plus the outer ring structure 155 in the middle section is not an integer. These outer ring structures 155 can not only be braided by the same single wire 104 as the inner stent body 154 , but also can be braided by different braided wires from the inner stent body 154 .

The middle section adopts the fifth structure weaving method:

After the single wire 104 is braided into a single-layer reticulated shell bracket 10, in the downstream section 13 of the bracket, another section 104' of the same braided single wire 104 is partially repeated in situ, and the bracket is rotated at an angle of about 60 degrees to reach the middle section 15 of the single wire 104 'Stretch out and break away from the already braided stent body 154 to make a half-arc line 166 or a full-arc line 166' and then return to the downstream section of the stent 13 and repeat the double-segment line locally. Single line 104 exit point 167 and entry point 167 ' like this, or support turns 120 degrees between entry point 167 and exit point 167 '. In this way, the downstream segment stent body 13 and the outer layer free tongue 156 of the middle segment 15 repeat back and forth three times until the outer layer free tongue 156 as shown in FIG. 5a is formed. Middle section has inner layer stent body 154 and outer layer free tongue 156 two-layer stent structure like this. The two layers are connected by a fixed edge 163 between the middle and downstream sections. The free tongue 156 of the outer layer starts from the bonding zone 133 between the downstream section 13 and the middle section 15 and extends outward to the upstream end 184 to the level of the bonding zone 183 between the middle section 15 and the upstream section 18 . The respective fixed edges 163 of two adjacent outer layer free tongues 156 have a common joint point 165 . The radial compression of these outer free tongues 156 facilitates delivery. Under the radial compression of the stent body, with the fixed edge 163 as the axis, the outer free tongue 156 can be radially compressed separately from the inner stent body 154 and approach the stent body, or released and expanded radially away from the stent body after the centripetal constraint force is removed. Bell mouth shape. Before the expansion of the stent body 154, the independently expanded outer free tongue 156 can first push into the natural valve leaflet bag of the aortic valve for automatic positioning. Regardless of whether the stent body is in a compressed state or an expanded state, these outer free tongues 156 can be independently radially compressed, and independently radially released and expanded to play a fixing role. These outer free tongues 156 enter the natural valve leaflet pockets and press against the bottom of the natural valve leaflet pockets and the natural valve leaflet juncture. When the valve leaflets of the stent valve are closed during diastole, the blood flows back, and the outer free tongue 156 can play a fixing role to prevent the stent valve from being rushed into the left ventricle by the blood flow. When the inner stent body 154 and the outer free tongue 156 are expanded, these outer free tongues 156 can be flatly attached to the outer surface of the stent, or can be trumpet-shaped and extend to the opening at the upstream end on the outer surface of the stent. The ratio of the number of perimeter deformable units CN to the number of axial length deformable units LN of the partially repeated double-segment line of the same braided single line 104 in the downstream section 13 is an integer, so as to ensure that the single line returns to the origin 105, 106. A semi-arc 166 can be formed between the single-line exit point 167 and the entry point 167 ', and it can also be a ring 166 ' above 360 degrees. The collar 166' can be completely dissociated, or can be re-embedded in the stent body in the downstream section. The outer free tongue 156 is an integral part of the self-expandable single wire stent. Outer layer free tongue 156 has two to three, 120 degree angles between. The outer free tongue 156 is generally half-moon arc-shaped, and the two ends of the arc line are connected to the support body. The outer free tongue 156 also has other variations. Such as: 1. Make a 360-degree bend at the top of the arc to form a small circle to increase the deformation elasticity; 2. Make a 360-degree bend at the top of the arc to form a large circle, and the radius of the large circle is almost the same as the half-arc radius; 3. Make a 360-degree large circle The downstream end of the stent is reprogrammed into the downstream support body. The free tongue 156 of the outer layer has less elastic force than the support body 154 because there are few lines. The outer free tongue 156 with low elasticity in the vessel lumen does not hinder the expansion of the stent body. The size and shape of the outer free tongue 156 and the cross-section of the stent body are consistent in the expanded state. These outer free tongues 156 can not only be woven by the same single wire 104 as the inner layer stent body 154 , but also can be woven together by different braided wires from the inner layer stent body 154 .

The middle section adopts the weaving method of the sixth structure:

The radial protruding structure 153 of the braiding method three is added with the free tongue 156 of the braiding method five. The stent can simultaneously have radially protruding structures 153 and outer free tongues 156 with the same size, shape, position, and number. After radial compression, the outer free tongue 156 is first released and expanded, corresponding to the natural valve cup and then embedded in the natural valve cup, so as to achieve rotational positioning and axial length positioning. The radially protruding structure 153 and stent body are then expanded. Outer layer free tongue 156 is because the line is few, so elastic force is lower than support body. The outer free tongue 156 with low elasticity in the vessel lumen does not hinder the expansion of the stent body. Both the radially protruding structure 153 and the outer free tongue 156 play a role in fixing. Both 153 and 156 sandwich the natural valve leaflets for sealing.

The open wire bend 102 and the sealed wire eye 103 in the present invention can also be cut from tubular material. The radial protruding structure 153 can also be formed by cutting and deforming a tubular material. The outer annular structure 155 and the outer free tongue 156 can also be formed by cutting and deforming tubular materials, and then welded together.

Continuing to refer to FIG. 1 to FIG. 6 , the artificial heart stent valve 1 of the present invention is provided with radiopaque markers, including point markers 311 and linear markers 312 .

The dot-like radiopaque markers 311 can be tube-shaped, coaxially sheathed on one or more braided wires 104 . The downstream end 134 of the stent has at least one or more X-ray-opaque point markers 311 . The upstream end 184 of the stent or the junction 183 between the upstream section and the middle section has at least one or more X-ray-opaque dot-shaped marks 311 , and these marks are located close to the cup bottom of the valve leaflet. The middle section 15 of the stent has at least one or more X-ray-opaque point markers 311, and the position of these markers can be located at the joint point 160 where the two radially protruding structures 153 are connected, corresponding to two joint points 332 adjacent to the valve leaflets. s position.

Referring to FIG. 5 , from the joint area line 183 of the upstream section 18 and the middle section 15 of the stent to the middle section 157 , an X-ray-opaque marking line 312 is made into two to three waveforms and connected end to end. The marking line 312 shuttles up and down in the stent braided mesh line 104 . This marking line is adjacent to the joint line 331 of the valve leaflet and the stent. The three wave marking lines in the stent can be used to fix the biological valve leaflets on the stent.

The radiopaque material can be biocompatible heavy metals such as gold, tungsten, platinum, and tantalum.

Continue referring to Fig. 1 to Fig. 6, the valve leaflet 33 in the artificial heart stent valve 1 of the present invention can have two to three, if be three valve leaflets, then be 120 degree distribution. Each valve leaflet includes a free edge 333 and a closing edge 334 . Between the free side 333 and the closing side 334 is a closing area 335 . The leaflet cups of the valve are curved and divided into a descending zone and an ascending zone. The bottom of the cup can be slightly lower than the joint line 331 between the valve leaflet and the stent. The junction line 331 is formed at the junction of the valve leaflet and the stent. The joint line of two adjacent valve leaflets communicates to form the leaflet joint point 332 . The leaflet commissure point 332 is at the crossing point 107, 107' of the braided wire 104. The leaflet commissure point 332 corresponds to the level of the closing edge 334 of the valve leaflet. The valve leaflets are made of soft materials, and the natural state is a closed state. The closing area 335 between the free edge 333 and the closing edge 334 of the adjacent valve leaflets is in contact, and the valve is closed so that blood cannot pass through. Vasodilation in the aorta during diastole causes the valve leaflets to close more tightly. During systole, the blood rushes through the valve leaflet 33, making the valve leaflet 33 stick to the stent or the vessel wall, and the stent valve 1 opens. The valve leaflets 33 may be composed of biological or synthetic materials. The synthetic material can be an elastomer such as silicone or polyurethane. There are one or more reinforcing fibers 39 in the valve leaflet of synthetic material, starting and ending at two different leaflet joint points 332 or joint lines 331 of the same valve leaflet 33, and connected to the bracket 10. The reinforcing fibers 39 are mainly on the aortic surface 340 side of the valve leaflet, so that the valve leaflet surface is a linear surface, while the ventricular surface 341 side of the valve leaflet is a smooth surface.

Continuing to refer to FIG. 1 to FIG. 6 , the artificial heart stent valve 1 of the present invention is provided with a sealing film, including an upstream sealing film 351 and a middle sealing film 354 .

A sealing film 351 is wrapped around the round tube 181 or trumpet-shaped opening 182 of the bracket upstream section 18 . The sealing membrane may extend upstream of the stent to form a pia 352 without stent support. This sealing membrane may extend in a downstream direction within the stent to the commissure line 331 . This sealing film has at least one internally and externally communicating sealing film eye 353 at the support upstream port 184, the open line turn 102 or the sealed line eye 103, for the support backguy 70 of the delivery device 2 to pass through. The upstream sealing film 351 ensures that blood does not leak from the same side of the stent valve 1 when the heart contracts. The pial border 352 ensures that the native mitral valve leaflets are not damaged during systole contact.

The upstream sealing membrane 351 continues to extend downstream from the leaflet joint line 331 to form a middle sealing membrane 354 . The mid-section sealing membrane 354 is a wavy membrane strip with almost equal width along the leaflet joint line 331 . In the middle portion 157x of the radially protruding structure 153 there is no membrane. The corrugated membranous band is narrower at the junctions 160, 332, allowing blood flow to the coronary arteries. During diastole, the middle sealing membrane 354 pushes against the vessel wall under the impact of aortic blood reflux, ensuring that blood does not leak from the same side of the stent valve 1 and flow back to the left ventricle through the aorta during diastole. The sealing membrane 354 in the middle section has no sealing membrane in the downstream section of the stent, which ensures blood perfusion to side branches such as coronary arteries during diastole. Guaranteed future coronary intervention.

The downstream section 13 of the stent is not provided with a sealing membrane, which ensures that the blood perfuses to the entrance of side branches such as coronary artery bypass grafts during diastole.

The metal frame wires of the deformable unit 101 without a sealing membrane, including the crossing points 107, 107', can be wrapped with elastic synthetic material.

The sealing membranes 351, 354 may be biological or synthetic membranes. Biofilms can exist on the inside, outside, or both inside and outside of the stent.

Synthetic sealing membranes 351, 354, which may be elastomers such as silicone, wrap the stent in between.

Continuing to refer to FIG. 1 to FIG. 6, the composite sealing membranes 351, 354 may contain reinforcing fibers 39, placed in a circumferential ring, and connected or bonded to the stent. Reinforcing fibers 39 may be at the edges of the composite sealing membrane, such as the edge of the soft membrane 352 and the edge of the midsection sealing membrane 354 . Synthetic sealing membranes can be composed of elastic polymer materials such as silicone, latex, polyurethane. The deformable unit in the shape of a lobe or other shapes is surrounded by elastic body, and when compressed radially, the deformable unit in the shape of a loom is extended along the longitudinal axis XX and shortened along the vertical horizontal axis. The extension of the longitudinal axis XX makes the elastic polymer material stretch elastically. After the external force is removed, the Ling-shaped deformable unit will restore its original length, and the elastic polymer material causes the stent to generate an additional radially outward expansion force. After compression, the stent becomes longer, the material flows to both sides, and the material on each section is reduced, which is beneficial to reduce the outer diameter of the stent valve under compression.

Referring to Fig. 3, sealing ring 37 can also be provided in the artificial heart stent valve 1 of the present invention, and sealing ring 37 is a soft tubular structure, surrounds support for a week, is positioned at the support outside of support upstream section 18 and middle section 15 junction zone 183, can It is in the shape of a ring around the XX axis or three waves along the joint line 331. The tubular structure can be sealed or semi-open. The semi-open sealing ring 37 has a dotted opening 373 (see FIG. 3f ) towards the inner or outer surface of the stent valve 1, or has a grooved opening 373′ (see FIG. 3e ) towards the inner surface of the stent valve 1 . The tubular structure can be constructed from biological or synthetic materials. It can be connected to the sealing membrane 35 . After the stent expands against the vessel wall, the tubular sealing ring 37 can be compressed to adapt to fill the gap between the stent and the vessel wall.

The elastic synthetic material membrane adopted in the artificial heart stent valve 1 of the present invention is provided with reinforcing fibers 39 . Unlike valve leaflets and sealing membranes made of biological materials, valve leaflets 33 and sealing membranes 351 , 354 made of elastic synthetic material may have reinforcing fibers 39 inside them. There are one or more reinforcement fibers 39 in the valve leaflet of synthetic material, which start and end at two different joint points 332 or joint lines 331 of the same valve leaflet, and are connected to the support 10; the reinforcement fibers 39 can be located at the free edge 333 of the valve leaflet 33 , mainly on the downstream surface 340 of the valve leaflet, the aortic side 340 of the downstream surface of the valve leaflet is made into a linear wrinkled surface, and the upstream surface of the valve leaflet on the ventricular side 341 is a smooth surface. The material of the reinforcing fiber 39 includes polyester fiber, high molecular polyethylene fiber, nylon and carbon fiber and the like. The reinforcing fiber 39 can selectively strengthen the strength of the elastic synthetic material membrane, and can also strengthen the strength between the synthetic membrane and the support. Reinforcing fibers 39 may also be on radiopaque markers 311,312.

Continuing to refer to FIG. 1 to FIG. 6 , the artificial heart stent valve 1 of the present invention is provided with a flexible coupling ring 41 . At the end of the support, the open line turn 102 and the sealed line eye 103, at the intersection point 107, 107' of the two braided lines between the two ends of the middle of the support, can be made of polyester, nylon, polyester, polypropylene glycol and other materials. The formed flexible wire constitutes the flexible coupling ring 41. The thin and soft flexible wires are first formed into a ring 412, the rings are of different sizes, and the wires are of different lengths. The two thread ends on the other side of the ring 412 are tied into a knotted cerclage 413 on the support to be integrated with it and cannot move. The delivery device pull wire 70 can pass through the flexible coupling ring 41, slide, and compress the bracket. The flexible coupling ring 41 is used to limit the swing range of the pull wire 70 and prevent dislocation.

In summary, the artificial heart stent valve of the present invention has the following characteristics and advantages:

1. There is a radial protrusion structure 153

Once the shape of the drum-shaped expansion body 152 in the middle part 15 of the stent valve is changed to the circular section of the downstream section 13 and the upstream section 18 , it can be divided into one or more radially protruding structures 153 . The radial protruding structure 153 is a protruding structure in the shape of a spherical shell surface, a parabolic curved surface, or the like on the outer surface of the bracket. The radial protruding structure 153 on the stent valve 1 is an integral part of the stent 10 . It may be composed of the same braided single wire 104 . Ideally, there are three hemispherical radially protruding structures 153 distributed about 120 degrees. The middle part 157x of the three radially protruding structures 153 has a larger diameter, which is beneficial for positioning and fixing along the xx axis and the rotation direction around the xx axis. Contrary to the stent-valve 1 in which the middle section 15 has a barrel shape 151, the radially protruding structure 153 sticks to the vessel wall. Two adjacent radially protruding structures 153 on the same plane are connected at the joint point 160 to form the leaflet joint point 332 . Two adjacent radial protruding structures are adducted at the joint point 160 and the leaflet joint point 332, and the outer diameter is smaller than that of the central part 157x of the protruding structure. In this way, the large-diameter stent has small-diameter valve leaflets in the working state, but there is enough opening area to reduce the tension of the valve leaflets; the damage of the valve leaflets 33 at the joint point 332 of the valve leaflets is reduced; the valve leaflets 33 cannot touch the stent 10 when the blood passes through. , so that the valve leaflets will not be worn due to collision with the stent; when the thickness of the valve leaflets 33 remains the same, the volume of the valve leaflets decreases when the diameter of the valve leaflets decreases, which is beneficial to radial compression. The upstream perimeter 159i of the half-moon forms the leaflet commissure line 331 connecting the valve leaflets 33 . Although adjacent deformable units of the same horizontal radially protruding structure 153 have unequal lengths, the sliding between adjacent sections of braided wire 104 on the braided stent intersecting point 107 ensures that the stent and the radially protruding structure can be compressed radially. to expand. The upstream port 184 of the bell mouth 182 of the upstream section that is not in one level is three wavy sides 185 corresponding to the three radially protruding structures 153 . Each segment of the braided wire 104 is the same length from the upstream end 184 to the downstream end 134 of the stent. When radially compressed and axially extended, the adjacent segments at the intersection point slide, the three radially protruding structures 153 and the three wavy shapes 185 disappear, and the deformable units at the upstream end are parallel. It is beneficial for the upstream end 184 to cooperate with the support pull wire of the open type wire turn 102 and the sealed type wire eye 103 of the delivery device 2 .

2. An outer ring structure 155 can be provided

The outer ring structure 155 does not seal the membrane and allows blood to pass through. The outer ring structure 155 cooperates with the specific support pull wire on the delivery device 2 and can be released separately before the support body 154 . The expanded outer ring structure 155 has positioning and fixing functions.

3. An outer free tongue 156 can be provided

The outer free tongue 156 is membrane-free and allows blood to pass. The outer free tongue 156 cooperates with the specific support backguy on the delivery device 2, and can be released separately prior to the support body 154. The expanded outer free tongue 156 has positioning and fixing functions. The joint point 165 of the outer free tongue 156 and the leaflet joint point 332 may have a definite rotational relationship, such as being on the same rotational plane.

4. The mesh support 10 can be composed of a single elastic braided wire 104

No matter what shape the self-expanding stent 10 can be braided from a single elastic braided wire 104 . A bracket composed of a single wire has strong integrity and is stronger mechanically without welding between wires. Individual line start points 105 and end points 106 may be welded together or overlapped. Both ends 105 and 106 of the braided wire of the single-wire stent are located between the downstream section 13 and the midstream section 15 of the stent. The two heads 105, 106 can face in one direction, toward the upstream end, or toward the downstream end. A single elastic braid 104 can be wound into open loops 102 and sealed eyes 103 . The sealed wire eye 103 can be on the same outer contour curved surface or tangent plane with the bracket, or can be inward or outward on a plane (diameter plane) perpendicular to the bracket, or can be in between. For a three-valve leaflet stent valve, the number of deformable units CN along the circumference is a multiple of three, which is beneficial to the symmetry of the three valve leaflets. The number CN of deformable units along the perimeter of the stent 10 woven by a single braided wire 104 divided by the number LN of deformable units along the long axis should be a fraction rather than an integer. The same single wire 104 can form the radially protruding structure 153 on the mesh stent 10 . The sliding between adjacent sections of braided wires at the intersection points 107, 107' ensures that the stent and the radially protruding structure 153 can be radially compressed and radially expanded. The same single wire 104 can overlap two or more times at the same position of the braided stent 10 . The same single wire 104 can be repeated in part or all of the braided stent 10 , and can also be braided into the outer ring structure 155 or the outer free tongue 156 of the stent.

5. A sealing ring 37 can be provided

After the stent valve expands, it bears against the blood vessel wall, and the tubular sealing ring 37 can be compressed to adapt to fill the gap between the stent and the blood vessel wall.

6. The upstream end of the stent valve 1 can be provided with a horn opening

The upstream port 184 of the upstream section 18 of the trumpet shape 182 is a three-lobed wave-shaped mouth 185 corresponding to the three radially protruding structures 153 . The sealing membrane 351 of the upstream section may extend outside the stent in the upstream direction to form a soft membrane 352 not supported by the stent.

7. There are X-ray opaque signs 311, 312

The radiopaque markers 311 can be located at the upstream end, the downstream end and the junction of the valve leaflets of the stent-valve. The braided stent has a single wire or overlapping multiple wire segments surrounded by a radiopaque ring tube. The X-ray-opaque ring tube can be used as an X-ray marker for positioning; prevent dislocation of two or more wires at the same position; and protect the braided wire ends 105, 106 from damaging tissues.

8. If the stent valve 1 is made of elastic synthetic material, the valve leaflets 33, sealing membranes 351, 354 and sealing ring 37 can have the following four functions at the same time:

a. The valve leaflets 33 prevent reflux, the basic functions of the sealing membranes 351, 354 and the sealing ring 37 as a leak-proof barrier.

b. The elastic deformation of the stent valve 1 is good

The quadrilateral deformable unit 101 is formed after the braided wires 104 of the self-expanding stent intersect. The coating on the intersection 107 of the two lines or between the quadrilaterals is covered with a film 351, 354 of elastic synthetic material. Both the scaffold and the membrane are elastic materials that deform elastically together under radial compressive forces. The quadrilateral deformable unit 101 is extended along the xx axis, and the covering film inside the quadrilateral deformable unit 101 is elastically extended along the xx axis. The stent valve in the equilibrium state against the vessel wall or in the working state, before the sealing membranes 351, 354 and the elastic synthetic material surface layer on the stent return to the original length and shape, the resilience of the elastic synthetic material membrane elastic deformation The radial expansion force and axial rebound force of the stent valve are increased. The valve leaflets and sealing membrane made of elastic materials can be super-expanded by the balloon after the stent valve is released, while the stent valve is still elastically deformed without being damaged.

c. The elastic synthetic material is wrapped on the metal stent wire to prevent the vascular epithelial cells from growing on the metal stent wire, so that the artificial stent valve is not adhered to the blood vessel wall and is ready to be taken out again.

D. Unlike biological valve leaflets, synthetic valve leaflets and sealing membranes can withstand low temperatures below 0°C, and will not impose special conditions for transportation, especially air transportation. Before assembly and compression, if the temperature of the Nitinol nickel-titanium shape memory alloy stent valve drops below Af, the nickel-titanium alloy changes from the Austenitic state to the Martensitic state, and the material becomes soft and the elasticity disappears, which is conducive to radial compression. After entering the body, heated to 37°C, the nickel-titanium memory alloy returns to the Austenitic state and returns to the super elastic state.

9. Equipped with reinforcing fiber 39

The reinforcing fibers 39 in the stent valve 1 selectively increase the strength of the elastic synthetic material valve leaflets 33 and the sealing membranes 351, 354, reducing the possibility of them being torn. The reinforcing fiber 39 in the synthetic stent valve 1 makes the synthetic valve leaflet 33 annularly reinforced, without hindering the opening and closing of the valve leaflet; the free edge of the synthetic valve leaflet 33 is reinforced to prevent it from tearing; the joint point and joint line of the synthetic valve leaflet 33 and the stent are reinforced , so that the joints become strong and not torn; the joints are smoothed to reduce thrombus formation; the sealing membranes 351, 354 and the bracket 10 are reinforced; the two lines on the braided line intersection 107 are tied and fixed.

10. The function of the open wire bend 102 and the closed wire eye 103 of the stent valve 1 and the cooperation with the stent pull wire of the delivery device: the open wire bend 102 and the sealed wire eye 103 increase radial elasticity and reduce material deformation; Reinforcing fibers in the elastic synthetic membrane can be fixed over the open crutches 102 and sealed eyelets 103; the sealed eyelets 103 can fix the commissure points 332 of the valve leaflets. If the sealed wire eye 103 is turned 90 degrees to the inside and is perpendicular to the incision plane, it can move the joint point 332 inward, and the valve leaflet tension decreases; the open wire crutch 102 and the sealed wire eye 103 are used for the support of the delivery device The pull wire cooperates to temporarily fix the stent valve 1 and compress it on the inner tube 51 of the delivery device. If the support backguy passes through the sealed eyelet 103, it will not slip off and move.

11. There is a flexible coupling ring 41

If the stent backguy passes through the flexible coupling ring 41 on the stent valve 1, it will not slip off and move.

Claims (27)

1. an artificial heart stent valve, is characterized in that: comprise a tubular mesh support that can radially deform between expansion state and compression state, this mesh support comprises upstream section, middle section and downstream section, mesh support A plurality of deformable units are formed or surrounded by each network cable, and a plurality of open wire bends are formed at both ends of the mesh support, and a sealed wire eye separate from the deformable unit is provided, inside the middle section of the mesh support It is connected with valve leaflets that can be switched on and off and allow blood to pass through in one direction. The junction of the valve leaflets and the mesh stent forms the leaflet joint line, and the intersection of the leaflet joint lines of two adjacent valve leaflets forms the leaflet joint point. The inner side and/or outer side of the upstream section of the mesh stent are covered with a sealing film and extend to the middle section. A plurality of X-ray-opaque signs and flexible coupling rings are arranged on the mesh stent, and the sealing film is made of biological materials. 2. The artificial heart stent valve according to claim 1, characterized in that: the mesh stent is woven from elastic wires or cut from elastic tubing. 3. artificial heart stent valve as claimed in claim 1, is characterized in that: described mesh stent overall is the circular tube shape of uniform size, is provided with support opening in the middle section of circular tube shape mesh stent. 4. The artificial heart stent valve according to claim 1, characterized in that: the middle section of the mesh stent is in the shape of a drum protruding outward, and a bracket opening is provided in the middle of the drum-shaped middle section. 5. artificial heart stent valve as claimed in claim 1, it is characterized in that: the middle section of described mesh support deforms at least one outwardly protruding radially protruding structure on the basis of circular tube shape or slight drum shape, A large bracket opening is provided in the center of each radially protruding structure. The connection between the radially protruding structure and the mesh bracket body forms a half-moon-shaped upstream periphery and a half-moon-shaped downstream periphery. The half-moon-shaped upstream periphery constitutes Leaflet commissure line connecting the valve leaflets. 6. The artificial heart stent valve according to claim 5, characterized in that: the radially protruding structure of the middle section of the mesh stent is one. 7. The artificial heart stent valve as claimed in claim 5, characterized in that: there are two radially protruding structures in the middle section of the mesh stent, and the two radially protruding structures are distributed at a 90-180 degree rotation angle. 8. The artificial heart stent valve according to claim 5, characterized in that: there are three radially protruding structures in the middle section of the mesh stent, and the three radially protruding structures are evenly distributed along the radial direction. 9. artificial heart stent valve as claimed in claim 5, it is characterized in that: the upstream section of described reticular support is trumpet-shaped, and the outer edge of trumpet-shaped upstream section is provided with the radial protruding structure corresponding with middle section Wavy lip. 10. artificial heart stent valve as claimed in claim 1, is characterized in that: the middle section of described reticular support is circular tube shape inside and outside double-layer structure, is connected with an outer layer annular structure on support body, outer layer The annular structure and the inner layer are connected at the downstream section or the junction of the downstream section and the middle section to form a fixed edge, and the outer annular structure ends at the junction of the upstream section and the middle section to form a free edge and is equipped with a sealed line eye and a deformable unit separate. 11. artificial heart stent valve as claimed in claim 1, is characterized in that: the middle section of described mesh stent is inner layer with circular tube shape or slight drum shape, and the outside is connected with at least one by a single mesh wire. The outer layer of the formed free tongue, the free tongue and the inner support body are connected at the downstream section or the junction of the downstream section and the middle section to form a fixed edge, and extend from the fixed edge to the upstream section to the junction of the upstream section and the middle section A free edge is formed, and the front end of the free edge is provided with a sealed line eye, and an X-ray-opaque mark is set on the line eye. 12. artificial heart stent valve as claimed in claim 11 is characterized in that: described free tongue is three, and three free tongues are distributed with 120 degree rotation angle, and correspond to valve leaflet. 13. artificial heart stent valve as claimed in claim 1, is characterized in that: the middle section of described mesh stent deforms at least one outwardly protruding radially protruding structure on the basis of circular tube shape or slight drum shape, Each radial protruding structure is connected with a free tongue surrounded by a single mesh wire, and the free edge of the free tongue overlaps with the half-moon upstream periphery of the radial protruding structure on two parallel curved surfaces, or the free tongue The free edge overlaps the perimeter of the radially protruding structure on two parallel curved surfaces. 14. The artificial heart stent valve according to claim 1, wherein the valve leaflets are made of biological materials. 15. artificial heart stent valve as claimed in claim 1, is characterized in that: described valve leaflet is made of synthetic material, is provided with at least one reinforcing fiber in synthetic material valve leaflet, and this reinforcing fiber starts and ends at the same valve leaflet Two distinct joint points or joint lines, connected on a mesh support. 16. The artificial heart stent valve according to claim 15, characterized in that: said reinforcing fiber is arranged on the downstream surface of the valve leaflet, or arranged on the free edge or closing edge of the valve leaflet. 17. artificial heart stent valve as claimed in claim 1,14 or 15, is characterized in that: described valve leaflet is two, and each valve leaflet comprises free edge and closing edge, forms between free edge and closing edge closed area. 18. artificial heart stent valve as claimed in claim 1,14 or 15, is characterized in that: described valve leaflet is three, and each valve leaflet comprises free edge and closing edge, forms between free edge and closing edge In the closed area, the three valve leaflets are distributed at a 120-degree rotation angle. 19. The artificial heart stent valve according to claim 1, characterized in that: said sealing membrane is provided with a sealing membrane eye communicating with the inside and outside at the sealing line eye of the mesh stent. 20. artificial heart stent valve as claimed in claim 1, is characterized in that: described sealing membrane is extended to the pia mater that does not have stent support outside mesh stent in upstream direction, extends to downstream direction in mesh stent Leaflet joint line. 21. The artificial heart stent valve according to claim 15, wherein the reinforcing fiber is selected from polyester fiber, polypropylene fiber, polyethylene fiber or carbon fiber. 22. The artificial heart stent valve according to claim 1, characterized in that: said X-ray-opaque mark is a tubular point-shaped mark set on a mesh wire, and the tubular point-shaped mark is arranged in the middle section of the mesh stent The joint point of the valve leaflets, or set at the upstream section of the mesh stent or at the junction of the upstream section and the middle section or at the downstream section. 23. The artificial heart stent valve according to claim 1, characterized in that: the radio-opaque markers are linear markers connected head to tail, and the linear markers are interwoven in a mesh shape adjacent to the joint line of the leaflets. network cable on the stand. 24. The artificial heart stent valve according to claim 1, characterized in that: said flexible coupling rings are arranged at the open wire turns and sealed wire eyes at both ends of the mesh stent and at the middle of the mesh stent. 25. artificial heart stent valve as claimed in claim 1, it is characterized in that: also comprise seal ring, this seal ring is arranged on the outside of the upstream section and middle section junction of mesh support, and described seal ring is soft half The open tubular structure is circular or wavy corresponding to the radially protruding structure, and is provided with a plurality of point-shaped openings facing the inner or outer surface of the stent valve, or provided with slot-shaped openings facing the inner surface of the stent valve. 26. The artificial heart stent valve as claimed in claim 25, wherein the sealing ring is made of biological material. 27. The artificial heart stent valve as claimed in claim 25, wherein the sealing ring is made of synthetic material.

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