CN113952082A

CN113952082A - Anti-backflow multifunctional heart valve prosthesis

Info

Publication number: CN113952082A
Application number: CN202111448084.1A
Authority: CN
Inventors: 赵晓辉
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-11-30
Filing date: 2021-11-30
Publication date: 2022-01-21

Abstract

The invention discloses an anti-backflow multifunctional heart valve prosthesis, which has good supporting capacity and flexibility by arranging a supporting piece, a special-form barb arrangement, a traction line and the like around the valve prosthesis, can better block a leakage orifice of a mitral valve or a tricuspid valve in a systole period, prevents the mitral valve or the tricuspid valve from flowing backwards when being closed, can furthest ensure the effective orifice area of blood flowing from the mitral valve or the tricuspid valve in a diastole period, prevents restenosis, and provides effective treatment for the mitral valve or the tricuspid valve against flowing backwards.

Description

Anti-backflow multifunctional heart valve prosthesis

Technical Field

The invention belongs to the field of heart repair technology and medical equipment, and particularly relates to an implantable valve prosthesis for treating heart valve regurgitation, which is used for replacing a native valve.

Background

The heart is a very important organ of the human body that powers the blood circulation of the human body, and contains four chambers, namely two atria, which fill the chambers, and two ventricles, which pump the chambers. The heart is divided into left and right portions, each of which contains a ventricle and an atrium, separated from each other by the ventricular septum and the atrial septum, with valves between the atria, the chambers and the arteries that prevent the backflow of blood, which normally allows the flow of blood through the heart in only one direction.

The four major valves in the heart represent the mitral and tricuspid valves of the mitral valve, which are respectively between the upper atrium and the lower ventricle, and are therefore also called Atrioventricular (AV) valves, acting as a one-way valve, ensuring that blood flows from the atrium to the ventricle and through a certain flow. Also, in the arteries leaving the heart there are the aortic and pulmonary valves. The mitral and aortic valves are in the left heart and the tricuspid and pulmonary valves are in the right heart. The valves incorporate leaflets or cusps, with each valve having three cusps, except for the mitral valve, which has only two cusps. The mitral and tricuspid valves are located between the atria and ventricles, respectively, and prevent backflow from the ventricles into the atria during systole. They are anchored to the wall of the ventricle by chordae tendineae, which prevent the valve from inverting, and attach to the papillary muscles to better hold the valve.

Mitral Regurgitation (MR) and Tricuspid Regurgitation (TR) are common heart diseases, and the function of the mitral valve depends on the integrity of its physiological structure. When the normal mitral valve is closed, the two valve leaflets are in the same plane and closely coapt, so that the backflow of the ventricular blood flow can be completely blocked. To achieve the effect, the mitral annulus is required to be proper in size, the valve leaflets are complete in structure, the papillary muscle contracts and pulls the chordae tendineae to play a supporting role on the valve leaflets, the closing force generated by contraction of the left ventricular muscle is proper, and the shape and the function of the ventricles are normal; in addition, functional tricuspid regurgitation is also recognized as a fatal disease in patients with left heart disease, and treatment of tricuspid regurgitation is usually not performed alone but is repaired in synchronization with the left heart disease. Particularly patients with long-term mitral regurgitation. The severe tricuspid regurgitation, which causes the reduction of cardiac output and the congestion of the systemic circulation, is a sign of poor prognosis of many heart diseases, and seriously affects the prognosis of patients. It is well documented that moderate to severe tricuspid regurgitation is closely associated with increased mortality. Currently, there are more than 500 million people with conservative estimates of moderate and severe mitral regurgitation or tricuspid regurgitation in china, of which only 0.5% can be operated, and the operation is mainly annuloplasty, and the rest of patients are not suitable for surgical treatment, so there is no suitable treatment scheme for such high-risk patients. Reflux occurs in 74% of patients treated by surgery three years later.

Current surgical treatment for mitral or tricuspid regurgitation is annuloplasty, leaflet repair, papillary muscle or chordae tendineae adjustment, edge-to-edge repair, and the like. With the progress of interventional therapy technology, the replacement or repair of the heart valve prosthesis by catheter delivery is rapidly developed and applied clinically, and a satisfactory effect is achieved. Prosthetic heart valves are implanted into the heart's native mitral valve by minimally invasive intervention procedures to replace or repair the damaged native valve for related work. The artificial heart valve mainly comprises a support and valve blades arranged in the support, and the operation process does not need to open the chest, so that the injury is small, the postoperative recovery is fast, and a new solution is provided for heart valve stenosis patients who cannot prolong the life or relieve the pain of the patients by the conventional treatment means at present.

But because the intervention treatment technology has short time, the application of the intervention treatment technology also faces more problems. For example, some prosthetic heart valves are prone to breakage during use due to insufficient support force; the degree of coincidence between the stent and the physiological structure of the natural valve is not enough, and perivalvular leakage is easy to occur; incomplete closure after implantation, reflux, etc. Aiming at the problems of the existing artificial heart valves, the technicians in the field are always searching different solutions, and the applicant of the invention develops intensive and innovative researches.

Disclosure of Invention

Aiming at the technical problems, the invention arranges the supporting piece around the valve prosthesis, the barb arrangement in a special form, the innovative design of the traction line and the like, so that the valve prosthesis has good supporting capacity and flexibility, can better block the leakage orifice of the mitral valve or the tricuspid valve in the systole period, prevents the mitral valve or the tricuspid valve from flowing backwards when being closed, can ensure the effective orifice area of blood flowing from the mitral valve or the tricuspid valve to the maximum extent in the diastole period, prevents restenosis, and provides an effective treatment scheme for the mitral valve or the tricuspid valve to flow backwards.

Specifically, the heart valve prosthesis of the present invention comprises: the support comprises a support, valve leaflets arranged on the inner side of the support and a covering film arranged on the wall of the support; the bracket comprises a first section, a second section and a third section which are sequentially connected, wherein the first section is a bell mouth-shaped net pipe, the second section is a roughly cylindrical net pipe, and the third section is a circular truncated cone-shaped net pipe; the heights of the first section, the second section and the third section are basically the same, the minimum pipe diameter of the first section is the same as that of the second section, and the maximum pipe diameter of the third section is the same as that of the second section. The middle part of first section is provided with visual component, and the lower part of first section is close to second section department and is provided with 2-4 support protruding poles, and the second section is close to the third section junction and is provided with and is used for sewing up the valve leaflet in the support and sews up the hole with the valve leaflet, still is provided with the barb near the third section junction at the second section simultaneously, and the valve leaflet is sewed up the hole and the barb interval sets up, barb evenly distributed is in second section periphery. At the free end of said third segment there are 2-5 connecting elements connected to one end of the pull cable and at the other end of the pull cable there is an anchor, whereby the heart valve prosthesis is anchored to the ventricular wall of the heart by means of the connecting elements, the pull cable and the anchor, in particular the prosthetic valve can be anchored to the heart at a location outside the heart.

The supporting convex rod is provided with two elastic supporting bodies, the two elastic supporting bodies are arranged at 90-150 degrees on the circumference of the supporting convex rod, each elastic supporting body comprises a linear portion, the linear portions are fixedly connected to the axial direction of the supporting convex rod along the length direction of the linear portions, one end, close to the non-free end of the supporting convex rod, of each linear portion is connected with an arc portion, and the other end of each arc portion is connected with an inclined portion. The inclined portion is inclined outwards from one end close to the arc-shaped portion to the other end, so as to increase the contact area between the supporting convex bar and the heart wall and to make the chair seat firmly fastened to the atrial wall of the heart, making the fixation more stable and reliable.

The barb is located the silk thread handing-over department of weaving of support, perhaps directly is located and weaves on the silk thread, when being located and weaves on the silk thread, silk thread same position on the barb can set up to two, and two the barb is 60-120 degrees angle settings in the circumference of weaving the silk thread, just each of barb is by weaving the outside arc slope setting of silk thread, two the barb sets up to spherical arch with the clearance department of weaving the silk thread to the toughness of reinforcing barb and anti shape of returning improve the fixed effect of barb on heart inner wall. In addition, two barbs at a certain angle can also be arranged at different positions of the same silk thread at intervals, and the interval distance is 1-3 cm. The forming process of the barbs is one or more of injection molding, stamping, mechanical cutting or laser cutting.

The traction cable is connected with the connecting piece of the third section through a connecting transition section, and one end of the connecting transition section, which is connected with the connecting piece, is provided with a connecting ring or a connecting buckle matched with the connecting transition section, so that the connecting transition section and the connecting piece are quickly connected in a buckling, penetrating or interlocking mode. The other end of connecting the changeover portion has the toper connector link, the one end of haulage cable links to each other with the connector link after through knoing, and the connector link is including grafting shell and lid, and the knot joint of haulage cable is acceptd in the cavity that grafting shell and lid formed, the other end of haulage cable has heart-shaped anchor portion, heart-shaped anchor portion can expand and fix in the apex of the heart position, from this tractive heart valve prosthesis, prevents that heart valve prosthesis from droing in the left atrium side. In addition, the pull cable may be a solid structure or may have a lumen through which the control element passes and moves proximally from outside the heart to properly adjust and position the leaflet and stent implantation locations.

The traction cable can be provided with an elastic safety section positioned in the middle, and the traction cable and the elastic safety section can be of an integral structure formed by the same elastic material and can also be formed by mutually buckling traction cable locking pieces. Elasticity safety section has tensile effect, can cushion the normal shrink action of heart, elasticity safety section is come and go naturally and is buckled into orderly shrink area body by the elasticity silk material, elasticity silk material cross section is rectangle or circular, elasticity safety section is fold form and can stretch for straightening the state completely under natural state, the both ends of elasticity safety section can have the elasticity fastener with the mutual lock joint of haulage cable, can have on the elasticity fastener along a plurality of notch cuttype arch of axial setting, every the arch all is the cusp and has the slope, the notch cuttype arch can with haulage cable lock catch spare looks lock joint to make to connect more swiftly, compact to the convenience is adjusted haulage cable length.

The angle theta at which the body wall of the third section of the stent is inclined relative to the body wall of the second section is 10 to 60 degrees, preferably 30 degrees.

In order to facilitate the positioning and monitoring of the implantation position of the prosthetic heart valve prosthesis, visualization elements are arranged on the first section and/or the covering film of the first section, the visualization elements are radiopaque markers, the number of the visualization elements is 2-4, and each visualization element is uniformly arranged along the circumferential direction of the stent. Specifically, if the "visualization element" is arranged on the first section of the bracket, a development hole needs to be arranged on the outer wall of the first section of the bracket, and a development medium is filled in the development hole; if the "visualization element" is provided in the coating, a developing medium is added to the coating material at a position where the "visualization element" needs to be provided. The developing medium is gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium and other materials or alloys or composites of the metals.

Preferably, the stent is made of nickel-titanium alloy or magnesium alloy, and the covering film is made of one or more of PET, e-PTFE, polyurethane material, artificial blood vessel material and pericardium material. The artificial valve in the stent can be made of animal (preferably pig) valves, pig or bovine pericardium, and can also be biological tissue materials, high molecular materials or tissue engineering valves.

The heart valve prosthesis of the present application, when implanted, has a first segment located at an atrium of the mitral or tricuspid valve and a third segment located at a ventricle of the mitral or tricuspid valve. The heart valve prosthesis has good supporting capacity and flexibility by arranging the supporting convex rod at the first section of the valve prosthesis, arranging the barb in a special form at the second section, and adopting the innovative design of the traction cable, and the like, so that the leakage orifice of the mitral valve or the tricuspid valve can be better blocked in the systole period, and the mitral valve or the tricuspid valve is prevented from being refluxed when being closed.

The artificial heart valve prosthesis has sufficient supporting force when in use, is more tightly attached to the inner wall of the heart, is more stable in fixation, is firmer and more fixed in traction, is not easy to break, and can be adjusted in length according to different people; the degree of coincidence between the stent body and the physiological structure of the natural valve is better, and perivalvular leakage is not easy to occur; after implantation, the closure is complete, and reflux is avoided.

Drawings

Fig. 1 is a schematic representation of the heart anatomy.

Fig. 2 is a front view of a stent of a prosthetic heart valve prosthesis according to an embodiment of the present invention.

Fig. 3 is a schematic view of the structure of the support lug of the present invention.

Figures 4-5 are schematic views of different barbs according to the present invention.

Fig. 6 is a schematic structural view of the traction fixing device of the present invention.

Fig. 7-8 are partial cross-sectional views of a pull cable of the present invention.

Detailed Description

Certain specific details are set forth in the following description and figures to provide an understanding of various embodiments of the invention. One of ordinary skill in the relevant art will understand that they can practice other embodiments of the invention without one or more of the details described herein. It is therefore not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. While the description of the various processes makes reference to sequences in the following disclosure, these sequences should not be construed as necessary to practice all embodiments of the present invention.

As used herein, the term "proximal" shall mean closer to the operator (less into the body) and "distal" shall mean further away from the operator (more into the body).

The prosthetic valve prosthesis and method of implantation of the present invention attempt to reduce or block the flow of blood from the ventricle into the atrium during systole and ensure that the amount of blood flowing from the atrium to the ventricle during diastole is adequate to avoid obstruction.

The following description refers to fig. 1 to 8. Those of ordinary skill in the art will recognize that the figures and drawing descriptions are directed to various embodiments of the invention and, unless the context indicates otherwise, do not limit the scope of the appended claims to the figures and/or drawing descriptions.

Fig. 1 is a schematic representation of the anatomy of a human heart with the mitral and tricuspid valves positioned between the atria and ventricles, respectively, to prevent backflow of blood from the ventricles into the atria during systole. In the case of the tricuspid valve, the tricuspid valve is composed of three approximately triangular valves or segments or leaflets. The base of which is connected to the annulus fibrosus surrounding the atrioventricular orifice and also to each other so as to form a continuous valve annulus, the function of the tricuspid valve being to prevent the backflow of blood into the right atrium; arrows indicate normal blood flow direction. Tricuspid regurgitation occurs when the valves of the tricuspid valve do not close completely, causing blood to leak back into the right atrium.

The heart valve prosthesis of the present invention comprises: the support comprises a support, valve leaflets arranged on the inner side of the support and a covering film arranged on the wall of the support; the bracket comprises a first section 1, a second section 2 and a third section 3 which are sequentially connected, wherein the first section 1 is a bell mouth-shaped net pipe, the second section 2 is a roughly cylindrical net pipe, and the third section 3 is a circular truncated cone-shaped net pipe; the heights of the first section 1, the second section 2 and the third section 3 are basically the same, the minimum pipe diameter of the first section 1 is the same as that of the second section 2, and the maximum pipe diameter of the third section 3 is the same as that of the second section 2. The middle part of first section 1 is provided with visual element 4, and the lower part of first section 1 is close to second section 2 department and is provided with 2-4 and supports protruding pole 8, and second section 2 is provided with near the 3 junctions of third section and is used for sewing up the leaflet in the support and sews up hole 6, still is provided with barb 5 near the 3 junctions of third section at second section 2 simultaneously, and the leaflet is sewed up hole 6 and barb 5 and is set up at the interval in week, barb 5 evenly distributed is in 2 peripheries of second section. At the free end of said third segment 3 there are arranged 2-5 connecting elements 7 connected to one end of a pull cable 14 and at the other end of the pull cable 14 there is arranged an anchor 15, whereby the heart valve prosthesis is anchored to the ventricular wall of the heart, in particular at a position outside the heart.

The supporting convex rod 8 is provided with two elastic supporting bodies 9, the two elastic supporting bodies 9 are arranged at 90-150 degrees in the circumferential direction of the supporting convex rod 8, each elastic supporting body 9 comprises a straight line portion 11, the straight line portions 11 are fixedly connected to the axial direction of the supporting convex rod 8 along the length direction of the straight line portion 11, one end, close to the non-free end of the supporting convex rod 8, of each straight line portion 11 is connected with an arc portion 12, and the other end of each arc portion 12 is connected with an inclined portion 10. Wherein angled portion 10 is angled outwardly from one end proximate to curved portion 12 to the other end, thereby increasing the contact area of support struts 8 with the heart wall and forming a tight fastening at the heart's atrial wall, which is more stable and reliable.

Barb 5 is located the knitting silk thread handing-over department of support, perhaps directly is located and weaves on the silk thread, when being located and weaves on the silk thread, silk thread same position barb 5 can set up to two, and two barb 5-1 is 60-120 degrees angle settings in the circumference of weaving the silk thread, just each of barb 5 is by weaving the outside arc slope setting of silk thread, two barb 5-1 sets up to spherical arch 5-2 with the clearance department of weaving the silk thread to the toughness of reinforcing barb and anti back shape of contracting improve the fixed effect of barb on heart inner wall. In addition, two barbs 5-3 and 5-4 with certain angles can also be arranged at different positions of the same silk thread at intervals of 1-3 cm. The forming process of the barbs 5 is one or more of injection molding, stamping, mechanical cutting or laser cutting.

The traction cable 14 is connected with the connecting piece 7 of the third section 3 through a connecting transition section 7-1, and a connecting ring or a connecting buckle matched with the connecting piece 7 is arranged at one end of the connecting transition section 7-1 connected with the connecting piece 7, so that the connecting transition section 7-1 and the connecting piece 7 are quickly connected in a buckling, penetrating or interlocking mode. The other end of the connecting transition section 7-1 is provided with a conical connecting buckle 13, one end of the traction cable 14 is connected with the connecting buckle 13 after knotting, the connecting buckle 13 comprises an inserting shell and a cover body, the knotted joint of the traction cable 14 is accommodated in a cavity formed by the inserting shell and the cover body, the other end of the traction cable 14 is provided with a heart-shaped anchoring part 15, the heart-shaped anchoring part 15 can be unfolded and fixed at the apex of the heart, so that the heart valve prosthesis is pulled, and the heart valve prosthesis is prevented from falling off at the left atrium side. In addition, the pull cable 14 may be a solid structure or may have a lumen through which a control element passes and moves proximally from outside the heart to properly adjust and position the leaflet and stent implantation site.

The pulling rope 14 may have a middle elastic safety section 16, and the pulling rope 14 and the elastic safety section 16 may be formed by an integral structure formed by the same elastic material or by fastening pulling rope locking pieces 17 to each other. Elasticity safety section 16 has tensile effect, can cushion the normal shrink action of heart, elasticity safety section 16 is come and go naturally and is buckled into orderly shrink area body by the elasticity silk material, elasticity silk material cross section is rectangle or circular, elasticity safety section 16 can be the fold form under natural state and can stretch for straightening the state completely, elasticity safety section 16's both ends 18, 19 can have the elasticity fastener 17 with the mutual lock joint of haulage rope, can have on the elasticity fastener 17 along a plurality of notch cuttype arch of axial setting, every the arch all is the cusp and has the slope, notch cuttype arch can be with the lock joint of haulage rope fastener 17 looks lock joint to make to connect more swiftly, compact, and the convenience is adjusted haulage rope length.

The angle theta at which the body wall of the third section 3 of the stent is inclined relative to the body wall of the second section 2 is 10 to 60 degrees, preferably 30 degrees.

In order to facilitate the positioning and monitoring of the implantation position of the prosthetic heart valve prosthesis, visualization elements 4 are arranged on the first section 1 and/or the covering film of the first section 1, the visualization elements 4 are radiopaque markers, the number of the visualization elements 4 is 2-4, and each visualization element 4 is uniformly arranged along the circumference of the stent. Specifically, if the "visualization element" 4 is arranged on the first section 1 of the stent, the outer wall of the first section 1 of the stent needs to be provided with a developing hole, and a developing medium is filled in the developing hole; if the "visualization element" 4 is provided in the coating, a developing medium is added to the coating material at a position where the "visualization element" 4 needs to be provided. The developing medium is gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium and other materials or alloys or composites of the metals.

The heart valve prosthesis of the present application is implanted with a first segment 1 at the atrium of the mitral or tricuspid valve and a third segment 3 at the ventricle of the mitral or tricuspid valve. Through at valve prosthesis first section 1 setting support protruding pole 8, set up innovative design such as barb 4 and pull cable 14 of special form at second section 2 to make heart valve prosthesis have good support capacity and elasticity, it is inseparabler with the laminating of heart inner wall, it is fixed more stable, can block up the leakage orifice of mitral valve or tricuspid valve better in heart systole phase, prevent that mitral valve or tricuspid valve from backflowing when closing.

The device for treating mitral valve regurgitation or tricuspid valve regurgitation provided by the invention can effectively treat mitral valve regurgitation and tricuspid valve regurgitation, has no blockage to blood flow in the heart, can adjust and recover the prosthesis, has the characteristics of strong operability of minimally invasive repair and high safety, and has higher clinical value.

Claims

1. An anti-regurgitation multifunctional heart valve prosthesis comprising: the support comprises a support, valve leaflets arranged on the inner side of the support and a covering film arranged on the wall of the support; the bracket comprises a first section, a second section and a third section which are sequentially connected, wherein the first section is a bell mouth-shaped net pipe, the second section is a roughly cylindrical net pipe, and the third section is a round table-shaped net pipe; the heights of the first section, the second section and the third section are basically the same, the minimum pipe diameter of the first section is the same as that of the second section, and the maximum pipe diameter of the third section is the same as that of the second section. The middle part of the first section is provided with a visual element, the lower part of the first section is provided with 2-4 supporting convex rods near the second section, the joint of the second section near the third section is provided with leaflet sewing holes for sewing the leaflets on the support, meanwhile, barbs are also arranged near the joint of the third section, the leaflet sewing holes and the barbs are arranged at intervals in the circumferential direction, and the barbs are uniformly distributed on the periphery of the second section; and 2-5 connecting pieces connected with one end of the traction cable are arranged at the free end of the third section, and an anchor is arranged at the other end of the traction cable.

2. The heart valve prosthesis of claim 1, wherein the support protrusion has two elastic supports disposed thereon, two of the elastic supports are disposed at 90-150 degrees circumferentially around the support protrusion, each of the elastic supports includes a linear portion fixedly connected to the support protrusion along a length direction thereof, an end of the linear portion near a non-free end of the support protrusion is connected to an arc portion, and another end of the arc portion is connected to an inclined portion, wherein the inclined portion is inclined outward from one end near the arc portion to another end thereof and is fastened to a wall of the heart.

3. The heart valve prosthesis of claim 2, wherein the barbs are located on a braided silk thread, the barbs on the same position of the silk thread can be arranged in two, and two barbs are arranged at an angle of 60-120 degrees in the circumferential direction of the braided silk thread, each barb is arranged by the inclined way of the braided silk thread towards the outer arc, and the two barbs and the gap of the braided silk thread are arranged in a spherical bulge.

4. The heart valve prosthesis of claim 2, wherein the two angled barbs are spaced apart at different positions on the same filament, the spacing being 1-3 cm.

5. The heart valve prosthesis of claim 3 or 4, wherein the barbs are formed by one or more of injection molding, stamping, mechanical cutting, or laser cutting.

6. The heart valve prosthesis as claimed in claim 2, wherein the pulling cable is connected to the connecting member of the third segment via a connecting transition section, and a connecting ring or a connecting buckle is provided at the end of the connecting transition section connected to the connecting member for cooperating with the connecting transition section, so that the connecting transition section and the connecting member can be connected rapidly via a snap-fit, a snap-fit or an interlocking manner.

7. The heart valve prosthesis as claimed in claim 6, wherein the other end of the connection transition section is provided with a tapered connection buckle, one end of the traction cable is connected with the connection buckle after knotting, the connection buckle comprises an insertion shell and a cover body, the knotting joint of the traction cable is accommodated in a cavity formed by the insertion shell and the cover body, and the other end of the traction cable is provided with a heart-shaped anchoring part; the pull cable may have a lumen through which the control element passes and moves proximally from outside the heart to properly adjust and position the leaflet and stent implantation site.

8. The heart valve prosthesis of claim 7, wherein the pull cable has a middle resilient safety section, and the pull cable and the resilient safety section are formed by fastening the pull cable fastener and the pull cable fastener together; elasticity safety section is come and go by the elasticity silk material and is buckled into orderly shrink area body naturally, elasticity silk material cross section is rectangle or circular, elasticity safety section is the fold form under natural state and can stretch for straightening the state completely, the both ends of elasticity safety section can have the elasticity fastener with the mutual lock joint of haulage cable, can have on the elasticity fastener along a plurality of notch cuttype arch of axial setting, every the arch all is the cusp and has the slope, the notch cuttype arch can with haulage cable lock catch spare looks lock joint.

9. The heart valve prosthesis according to claim 1, wherein the stent is made of nickel-titanium alloy or magnesium alloy, and the covering film is made of one or more of PET, e-PTFE, polyurethane material, artificial blood vessel material and pericardium material; the artificial valve in the stent can be made of animal (preferably pig) valves, pig or bovine pericardium, and can also be biological tissue materials, high molecular materials or tissue engineering valves.