Implantable aortic bioprosthesis

Abstract

The present invention discloses an implantable aortic biovalve, comprising a valve stent, an artificial valve, a skirt, and a plurality of anchors. The artificial valve is arranged in the valve stent, dividing the valve stent into a first area and a second area; the skirt is an annular surface covering the second area, and the skirt extends toward the blood inflow end of the aortic valve, and the outer wall of the skirt is used to abut and seal with the leaflets of the aortic valve. The anchors are arranged in the first area, and are evenly or unevenly arranged along the circumference of the valve stent. The anchors have a convex structure, and the convex structure is used to abut with the inner wall of the aortic valve. In this way, the valve stent is fixed to the aortic valve, and at the same time, the skirt is sealed and fitted with the leaflets of the aortic valve, so that the skirt and the leaflets of the aortic valve are kept sealed, effectively improving the sealing between the valve stent and the aortic valve, reducing the risk of leakage outside the valve stent, and reducing the possibility of blood backflow into the left ventricle.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an implantable aortic biovalve. Background Art

[0002] The aortic valve is a valve located between the left ventricle and the aorta. It is composed of three semilunar leaflets, whose leaflet attachment edges extend in an arc shape across the ventricle-artery junction, so that each leaflet is attached to the aorta within the left ventricle. The aortic wall bulges outward on the posterior side of the leaflets to form the aortic sinus. When the three leaflets are closed, they adhere to each other along the commissure edges toward the center. When the ventricles contract, blood rushes upward, pushing the leaflets of the aortic valve away from the center of the aortic cavity, and blood flows from the ventricles into the aorta. When the ventricles relax, the leaflets passively descend into the center of the aortic cavity. The three leaflets mate along the commissure edges and support the blood column in the aorta to prevent blood from flowing back into the ventricles.

[0003] Aortic valve stenosis is a condition that many people in today's society may suffer from, especially in the middle-aged and elderly population, where the incidence is increasing. Initially, the treatment for aortic valve disease relied primarily on conservative medication, but the treatment was ineffective. Subsequently, surgical aortic valve replacement (SAVR) emerged, in which an artificial valve is implanted into the aorta through a thoracotomy. Surgical implants are divided into two types: mechanical valves and bioprosthetic valves. Mechanical valves require long-term anticoagulation, while bioprosthetic valves have poor durability, leading to considerable controversy regarding the choice of prosthetic valve. With breakthroughs in bioprosthetic valve processing technology by some biotechnology companies, the preference for prosthetic valves has begun to shift from mechanical valves to bioprosthetic valves. However, surgical valve replacement through thoracotomy still carries significant surgical risks for elderly, high-risk patients, resulting in the majority of these patients being treated conservatively.

[0004] In the 21st century, with the increasing maturity of transcatheter implantation technology and the emergence of new devices for heart valve disease, France successfully treated a 57-year-old male patient with severe calcific aortic stenosis who was at high risk of surgery for the first time through transcatheter aortic valve replacement (TAVR) in 2002. The principle is to replace the original valve with an artificial valve to ensure the normal flow of blood. The development of TAVR is based on PCI (Percutaneous Coronary Intervention), which applies interventional technology to a new field and has achieved good results. After more than ten years of development, more than 300,000 people have received treatment with this technology.

[0005] However, in the prior art, medical devices using this method mainly include a stent and an artificial valve arranged in the stent. When the stent is placed in the aorta, it needs to use its own expansion to abut against the tissue of the aorta, so that the stent is fixed.

[0006] The leaflets of the original aortic valve will also be squeezed against the stent, causing the fixation of the stent to be extremely unstable, and there is a risk of the stent falling into the left ventricle or aortic cavity. Moreover, the stent itself is a grid-like structure, relying only on its side to abut against the aortic tissue to achieve its sealing. The sealing effect is relatively poor, and there is a risk of paravalvular leakage. Paravalvular leakage refers to the residual leakage between the artificial valve ring and the patient's valve ring after valve replacement surgery, which poses a major hidden danger to the patient's health. In order to better fix the stent itself, its length is relatively large, which can easily affect the left and right coronary artery openings in the aorta, hindering the subsequent coronary intervention surgery that may be required.

[0007] Based on this, there is an urgent need for an implantable bioprosthetic valve to solve the problems mentioned above. Summary of the Invention

[0008] The purpose of the present invention is to provide an implantable aortic biovalve that solves the problem in the prior art that after the stent is fixed, the fixation and sealing effect is poor only by relying on the expansion of the stent itself, and the stent is large in size and easily interferes with coronary intervention surgery.

[0009] To achieve this object, the present invention adopts the following technical solutions: an implantable aortic biovalve, comprising: a valve stent, which is hollow inside and penetrated at both ends; an artificial valve, which is arranged at a position corresponding to the cross-section of the valve stent, and the artificial valve separates the valve stent into a first area and a second area, the first area facing the blood outflow end of the aortic valve, and the second area facing the blood inflow end of the aortic valve; a skirt, which is an annular surface covering the second area, and the skirt extends toward the blood inflow end of the aortic valve, and the outer wall of the skirt is used to abut and seal with the leaflets of the aortic valve; and a plurality of anchors, which are arranged in the first area and are evenly or unevenly arranged along the circumference of the valve stent, and the anchors have a protruding structure protruding from the surface of the first area in the radial direction of the valve stent, and the protruding structure is used to abut with the inner wall of the aortic valve.

[0010] Optionally, the skirt has a first end and a second end, the first end facing the blood outflow end of the aortic valve, and the second end facing the blood inflow end of the aortic valve; in the axial direction of the valve stent, the artificial valve is located between the first end and the second end, and the axial dimension between the artificial valve and the second end is greater than the axial dimension of the second area.

[0011] Through the above technical solution, the valve stent and the aortic valve are kept sealed, and blood can only pass through the valve stent through the artificial valve.

[0012] Optionally, the skirt is in the shape of an annular sheet, and the outer diameter of the second end is greater than the outer diameter of the first end.

[0013] Through this technical solution, the side of the skirt can closely contact the aortic valve, and the sheet-like skirt also increases the contact area between the aortic valve and the aortic valve, thereby achieving a seal between the two. At the same time, the increased outer diameter of the second end also creates a certain snapping effect between the skirt and the aortic valve, smoothly securing the stent within the aortic valve.

[0014] Optionally, the generatrix of the skirt is a curve with continuously changing curvature; or the generatrix of the skirt is a curve with an inflection point.

[0015] The curved transition formed by the curvature of the curve described above further increases the contact area between the skirt and the aortic valve, improving the seal between them. The curved transition with an inflection point also creates a better engagement between the skirt and the aortic valve, enhancing the stability of the valve stent installation.

[0016] Optionally, the first end of the skirt is sewn to the outside or inside of the valve support.

[0017] Through the above technical solution, the skirt can be mounted on the outside of the valve stent to directly abut against the aortic valve, and the skirt can also be attached to the inside of the valve stent to seal the second area of ​​the valve stent.

[0018] Optionally, the first end of the skirt is a double-layer structure with a sandwich, and the valve stent is inserted into and fixedly connected to the sandwich.

[0019] Through the above technical solution, the valve stent is inserted into the interlayer, so that the connection strength between the skirt and the valve stent is improved, while also ensuring that the skirt directly abuts the aortic valve to improve the sealing of the valve stent after installation.

[0020] Optionally, the valve stent has a grid structure, and each grid unit in the grid structure shrinks or stretches to both sides with a diagonal line parallel to the axis as a symmetry line, driving the valve stent to compress or expand.

[0021] Through the above technical solution, when delivering the valve stent, the valve stent can be contracted first to facilitate the movement of the valve stent. After the valve stent moves to the aortic valve, each grid structure is expanded, so that the valve stent is supported at the aortic valve.

[0022] Optionally, the thickness of the valve stent is less than 0.6 mm; and / or the axial length of the valve stent is greater than 8 mm and less than 40 mm.

[0023] By making the stent thinner, the above-mentioned technical solution effectively increases the stent's contraction range, facilitating its insertion into smaller delivery catheters. Furthermore, the shorter overall length allows the stent to be exposed above the coronary ostium after expansion, facilitating other interventional procedures.

[0024] Optionally, the anchor is a barb, one end of the barb is connected to the valve stent, and the other end of the barb is inclined toward a side away from the valve stent; or the anchor is a protrusion that bulges radially outward.

[0025] With the above technical solution, after the valve stent is expanded, the multiple barbs can abut against the inner wall of the aorta, thereby fixing the valve stent at the aortic valve and preventing the valve stent from falling into the left ventricle. The protrusions abut against the inner wall of the aorta, and the contact area between the protrusions and the aorta is large, so that the valve stent is evenly stressed in all directions, thereby ensuring the stability of the valve stent and reducing the possibility of the valve stent falling into the left ventricle.

[0026] Optionally, the skirt is made of polyethylene terephthalate, polytetrafluoroethylene, bovine pericardium, or porcine pericardium.

[0027] Through the above technical solution, polyethylene terephthalate has good physical and mechanical properties, and its creep resistance, fatigue resistance, friction resistance and dimensional stability are very good. Polytetrafluoroethylene has an extremely low friction coefficient, and is chemically stable, corrosion-resistant, and has strong sealing properties. Both bovine pericardium and porcine pericardium have good biocompatibility, low antigenicity, and are not prone to rejection reactions. Therefore, they can be used to manufacture skirts and other structures that are in direct contact with human tissues.

[0028] To achieve the above-mentioned purpose, the present invention also provides another implantable aortic biovalve, which includes: a valve stent, which is tubular and has a first end and a second end arranged opposite to each other in the axial direction; an artificial valve, which is arranged in the inner cavity of the valve stent, and the artificial valve divides the valve stent into a first area and a second area arranged in sequence along the axial direction; a plurality of anchors, which are arranged on the outside of the first area and are arranged at intervals along the circumference of the valve stent; one end of each of the anchors is connected to the valve stent, and the other end extends in a direction away from the valve stent; a skirt, which covers the second area and part of the first area, and the skirt has a first end and a second end arranged opposite to each other, the first end is located between the artificial valve and the anchor, the second end extends beyond the second area, and the outer diameter of the second end is larger than the outer diameter of the first end.

[0029] Beneficial effects of the present invention:

[0030] The implantable aortic bioprosthesis provided in this application is used in aortic valve implantation surgery. An artificial valve is provided inside the valve stent to replace the original aortic valve leaflets. The skirt and anchors provided on the valve stent can secure the valve stent on both sides, thereby securing the valve stent to the aortic valve. The skirt can maintain a seal between the valve stent and the aortic valve, effectively improving the seal between the valve stent and the aortic valve and reducing the risk of leakage outside the valve stent. When blood flows, it can only flow through the second region and the first region in sequence as the artificial valve opens, and does not flow through the outside of the valve stent. This can reduce the possibility of blood backflow into the left ventricle. It can also effectively reduce the size of the implant and reduce the difficulty of the surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 Shown is a schematic diagram of the structure of an implantable aortic bioprosthesis.

[0032] Figure 2 Shown is a schematic structural diagram of an artificial valve of an implantable aortic biovalve in some embodiments of the present invention.

[0033] Figure 3 Shown is a schematic structural diagram of the skirt of an implantable aortic bioprosthesis in some embodiments of the present invention.

[0034] Figure 4 Shown is a schematic diagram of the expanded structure of a valve stent of an implantable aortic biovalve in some embodiments of the present invention.

[0035] Figure 5 Shown is a schematic structural diagram of the expanded valve stent of an implantable aortic biovalve in some embodiments of the present invention.

[0036] Figure 6 Shown is a schematic structural diagram of the barbs of an implantable aortic biovalve extending toward the left ventricle in some embodiments of the present invention.

[0037] In the picture:

[0038] 100. Valve stent; 110. First region; 120. Second region; 200. Artificial valve; 300. Skirt; 400. Anchor. DETAILED DESCRIPTION

[0039] The present invention will be further described in detail below with reference to the accompanying drawings and examples. It will be understood that the specific embodiments described herein are intended only to illustrate the present invention and are not intended to limit the present invention. It should also be noted that, for ease of description, the accompanying drawings only illustrate portions relevant to the present invention, not all structures.

[0040] In the description of the present invention, unless otherwise expressly specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention in specific circumstances.

[0041] In the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Furthermore, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0042] In the description of this embodiment, the terms "upper," "lower," "right," and other orientations or positional relationships are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely for ease of description and simplified operation. They do not indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meanings.

[0043] The implantable aortic bioprosthetic valve provided by the present invention is formed from an alloy material into a cylindrical grid-shaped valve stent with openings on both sides. The stent has a small thickness and length, allowing it to be collapsed and placed within a small delivery catheter, allowing percutaneous delivery via either the femoral or brachial artery. Furthermore, after expansion, it does not affect the left or right coronary artery openings within the aorta, facilitating subsequent coronary intervention. The artificial valve is secured to the stent's outer wall or outer wall by sewing. The stent may also be provided with a thin, trumpet-shaped skirt that seals against the aortic valve, thereby achieving a seal between the stent and the aortic valve and reducing the possibility of paravalvular leakage. The artificial valve is located within the skirt, allowing blood to flow out only when the valve is open. A specialized anchoring structure is also provided on the stent's outer wall away from the skirt. The anchoring structure is capable of abutting the interior of the aortic lumen. The anchoring structure and the skirt cooperate to secure the valve stent on both sides, thereby reducing the possibility of the valve stent falling into the left ventricle or aorta. This will improve the success rate of artificial valve implantation.

[0044] Figure 1 The figure shows the structure of the implantable aortic bioprosthesis. Figure 1 As shown, the implantable aortic biovalve includes: a valve stent 100, an artificial valve 200, a skirt 300 and a plurality of anchors 400. The valve stent 100 is tubular, hollow inside and penetrated at both ends. The artificial valve 200 is arranged in the inner cavity of the valve stent 100. Specifically, the artificial valve 200 is sewn on the cross section of the valve stent 100, and the valve stent 100 is divided into a first area 110 and a second area 120. The first area 110 and the second area 120 are arranged in sequence along the axial direction of the valve stent 100. The artificial valve 200 is used to selectively connect or block the first area 110 and the second area 120. The first area 110 is toward the blood outflow end of the aortic valve, that is, connected to the aortic cavity; the second area 120 is toward the blood inflow end of the aortic valve, that is, connected to the left ventricle.

[0045] The skirt 300 is an annular surface that covers the second region 120. The skirt 300 has a first end and a second end that are oppositely disposed. The first end is connected to the valve stent 100 and faces the blood outflow end of the aortic valve, while the second end faces the blood inflow end of the aortic valve, that is, the left ventricle. The outer wall of the skirt 300 abuts and seals against the leaflets of the aortic valve. The skirt 300 covers the second region 120 and a portion of the first region 110. In the axial direction of the valve stent 100, the artificial valve 200 is located between the first end and the second end, and the axial dimension between the artificial valve 200 and the second end is greater than the axial dimension of the second region 120. In other words, the second end of the skirt 300 extends beyond the second region 120.

[0046] A plurality of anchors 400 are arranged on the outside of the first region 110 and are spaced apart along the circumference of the valve stent 100. The first end of the skirt 300 can be located between the artificial valve 200 and the anchor 400. One end of each anchor 400 is connected to the valve stent 100, and the other end extends in a direction away from the valve stent. The plurality of anchors 400 can be evenly or unevenly distributed along the circumference of the valve stent 100. The anchor 400 has a protruding structure protruding from the surface of the first region 110 in the radial direction of the valve stent 100, and the protruding structure is used to abut against the inside of the aortic cavity to cooperate with the skirt 300 to fix the valve stent 100.

[0047] Specifically, the valve stent 100 is cylindrical and can shrink and expand radially. Its material can be an alloy material with memory properties. It can remain contracted during transportation so as to be placed in the delivery catheter. After being delivered to the designated position, it can expand to support the corresponding position.

[0048] Figure 2 FIG2 is a schematic diagram showing the structure of an artificial valve of an implantable aortic bio-valve in some embodiments of the present invention. Figure 2 As shown, the artificial valve 200 may include multiple leaflets, such as three or four, and the multiple leaflets are arranged along the circumference of the valve stent 100 and are tightly attached in sequence, and the sides of the multiple leaflets that are attached to each other are all arc-shaped, and the intersection of the three arc-shaped surfaces is located on the axis of the valve stent 100, so that the three leaflets can flip from the center of the valve stent 100 to the edge of the valve stent 100, so that the blood in the left ventricle can flow into the aorta. The leaflets can be directly sewn on the inside or outside of the valve stent 100, and the leaflets can also be a double-layer structure, and the double-layer structure is sewn and connected to the inside and outside of the valve stent 100 respectively. In an embodiment of the present invention, three leaflets are provided to control the opening and closing of the aorta. It should be understood that in other embodiments of the present invention, four or two leaflets can also be provided.

[0049] The skirt 300 can be shaped as a trumpet, with the outer diameter of the second end surface of the skirt 300 being greater than the outer diameter of the first end surface. The outer diameter can change gradually from the first end to the second end, such as through a curved transition, or it can change suddenly from the first end to the second end, such as through an angled transition. The skirt 300 is configured so that as the valve stent 100 expands, the skirt 300 conforms to the leaflets of the native aortic valve, thereby forming a seal between the skirt 300 and the leaflets of the aortic valve. The anchor 400 is disposed on the valve stent 100 and can be made of the same material as the valve stent 100. Therefore, the anchor 400 expands as the valve stent 100 expands, allowing it to abut the inner wall of the aortic lumen. The shape of the anchor 400 can be an outwardly convex arc, a barb, or any other shape that conforms to the inner wall of the aortic lumen. The specific design depends on the actual application and is not limited by the present invention.

[0050] When the artificial valve 200 is implanted, the valve stent 100 is extended into the middle of the aortic valve using a delivery system, with the first region 110 facing the aorta and the second region 120 facing the left ventricle. The second end of the skirt 300 will extend into the left ventricle. As the valve stent 100 expands, the skirt 300 can be abutted against the aortic valve, and the anchor 400 will then abut against the inner wall of the aorta. The anchor 400 cooperates with the skirt 300 to fix the valve stent 100 on both sides of the aortic valve, thereby fixing the valve stent 100 between the aortic valves. At the same time, the skirt 300 is sealed against the leaflets of the aortic valve, so that the skirt 300 and the leaflets of the aortic valve are sealed, effectively improving the sealing between the valve stent 100 and the aortic valve, and reducing the risk of paravalvular leakage outside the valve stent 100. When blood flows, since the artificial valve 200 is placed in the skirt 300, the blood can only flow through the second area 120 and the first area 110 in sequence as the artificial valve 200 opens, and will not flow through the outside of the valve stent 100, thereby reducing the possibility of blood reflux into the left ventricle.

[0051] In some embodiments of the present invention, the valve stent 100 is provided with a developable marking point. The marking point is located outside the first region 110 to indicate the position of the valve stent 100. Specifically, the marking point can be fixed to the outside of the first region 110 in an inlaid manner. The specific location of the marking point can be designed based on the actual application scenario and is not specifically limited by the present invention. The manufacturing material of the marking point can be a platinum-iridium alloy or a tantalum alloy. In the embodiment of the present invention, the marking point is made of a tantalum alloy.

[0052] In some embodiments of the present invention, the valve stent 100 is made of nickel-titanium alloy, stainless steel, or cobalt-chromium alloy. The skirt 300 is made of polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), bovine pericardium, or porcine pericardium. The artificial valve 200 is made of bovine pericardium or porcine pericardium.

[0053] Specifically, the valve stent 100 is preferably made of nickel-titanium alloy, a shape-memory alloy that can both contract and expand to restore its shape, while also exhibiting excellent wear resistance and corrosion resistance. The valve stent 100 made of nickel-titanium alloy can effectively achieve overall contraction and expansion. Polyethylene terephthalate (PET) exhibits excellent physical and mechanical properties over a wide temperature range, as well as good creep resistance, friction resistance, and dimensional stability. The skirt 300 made of PET can achieve a good seal fit with the leaflets of the aortic valve. Polytetrafluoroethylene (PTFE) is non-toxic, corrosion-resistant, and has excellent sealing and stability. The skirt 300 made of PTFE can also achieve a good seal fit with the leaflets of the aortic valve. Bovine and porcine pericardium, after bioengineering treatment, have excellent biocompatibility, low antigenicity, and are less likely to produce rejection reactions. Furthermore, their overall biological tissue stability is very good, making them suitable for manufacturing the skirt 300 and the artificial valve 200.

[0054] Figure 3 FIG2 is a schematic diagram showing the structure of the skirt of an implantable aortic bioprosthesis in some embodiments of the present invention. Figure 1 and Figure 3 As shown, in some embodiments of the present invention, the skirt 300 is in the shape of an annular thin sheet, and the outer diameter of the second end is greater than the outer diameter of the first end. Specifically, the skirt 300 can be trumpet-shaped as a whole, mounted on the valve stent 100, and its generatrix is ​​a curve with a continuously changing curvature, so as to form a curved surface transition on its outer surface, so that the first end and the second end are connected together. The outer wall of the skirt 300 with a curved surface transition can better achieve a sealing fit with the aortic valve. The generatrix of the skirt 300 can also be a curve with an inflection point, so as to form an angled surface transition on its outer surface, so that the first end and the second end are connected together. For example, the angle between the second end and the first end is 90 degrees, so that the second end of the skirt 300 can be better clamped on the aortic valve. It should be understood that the degree of continuous curvature change or the angle and number of inflection points can be designed according to the actual needs of the operation and are not specifically limited in this application.

[0055] In some embodiments of the present invention, the first end of the skirt 300 is sewn to the inside or outside of the valve stent 100. Specifically, the outer diameter of the first end of the skirt 300 can be larger than the outer diameter of the valve stent 100, in which case the first end of the skirt 300 is sleeved on the outside of the valve stent 100. Alternatively, the outer diameter of the first end of the skirt 300 can be smaller than the inner diameter of the valve stent 100, in which case the skirt 300 is sleeved on the inside of the valve stent 100. The specific size of the skirt 300 can be determined based on actual application requirements.

[0056] Reference Figure 3 As shown, in some embodiments of the present invention, the first end of the skirt 300 is a double-layer structure with an interlayer. The double-layer structure is for inserting the valve stent 100, and the valve stent 100 is sewn into the interlayer. Specifically, the interior of the double-layer skirt 300 and one side near the first end can be hollowed to form the above-mentioned interlayer, for inserting the valve stent 100 therein, and then the valve stent 100 and the skirt 300 are fixedly connected by sewing. The provision of this interlayer can effectively improve the connection strength between the valve stent 100 and the valve.

[0057] Figure 4 FIG2 is a schematic diagram showing the expanded structure of the valve stent of the implantable aortic bio-valve in some embodiments of the present invention. Figure 4 As shown, the valve stent 100 is a grid structure, and each grid unit in the grid structure has a symmetry line. The grid unit can shrink or stretch to both sides along the symmetry line, and the symmetry line is parallel to the axis of the valve stent 100 and is served by the diagonal line of the grid unit. To drive the valve stent 100 to compress or expand. Specifically, the valve stent 100 is integrally formed, and can be made by laser engraving, electrochemical polishing, and heat treatment. The grid structure can be a rhombus or other polygon, which has two opposite vertices in the axial direction of the valve stent 100 and two opposite vertices in the radial direction of the valve stent 100. The two radial vertices can be close to or away from each other, so that each grid structure is compressed or expanded, thereby realizing the compression or expansion of the valve stent 100. It should be understood that the specific shape of the grid structure can be designed according to the actual application needs, such as a hexagon, etc., and the present invention does not make specific limitations.

[0058] In some embodiments of the present invention, the thickness of the valve stent 100 is less than 0.6 mm. Specifically, the thickness of the valve stent 100 can be between 0.05 mm and 0.6 mm, thereby improving the radial compressibility of the valve stent 100, so that the valve stent 100 with an inner diameter of 50 mm after expansion can be compressed to a smaller diameter to facilitate loading into a delivery catheter with a smaller inner diameter. The outer diameter of the delivery catheter can be 8 to 16F (feet), so that the valve stent 100 can be delivered percutaneously through the femoral artery or through the brachial artery, thereby providing multiple access methods for interventional treatment.

[0059] Figure 5 FIG2 is a schematic diagram showing the structure of the implantable aortic bio-valve after expansion of the valve stent in some embodiments of the present invention. Figure 5 As shown, in some embodiments of the present invention, the length of the valve stent 100 is greater than 8 mm and less than 40 mm. Specifically, the length of the valve stent 100 can be any value between 12 mm and 30 mm, so that the valve stent 100 can be effectively fixed between the aortic valves, and the coronary ostium in the aortic cavity can be prevented from leaking out, thereby preventing the valve stent 100 from blocking the coronary ostium, and providing a feasible solution for other interventional treatments through the coronary ostium in the future. The coronary ostium refers to the right coronary artery (RCA) and the left coronary artery (LCA).

[0060] Figure 6 FIG2 is a schematic diagram showing the structure of the implantable aortic bioprosthetic valve with the barbs extending toward the left ventricle in some embodiments of the present invention. Figure 1 and Figure 6 As shown, in some embodiments of the present invention, the anchor 400 is a barb. One end of the barb is connected to the valve stent 100, and the other end of the barb is tilted toward the side away from the valve stent 100, so that the side of the barb away from the valve stent 100 abuts against the inner wall of the aorta. Specifically, the barb is a semi-annular structure composed of two arc-shaped rods, and one end of the two arc-shaped rods is fixedly connected to two fulcrums of a grid structure of the valve stent 100, or connected to two side rods of a grid structure of the valve stent 100, and the other ends of the two arc-shaped rods are intersected and fixed to form a semi-annular structure. The tilt direction of the barb can be toward the side of the aorta, or toward the side of the left ventricle. The specific direction of the barb can be designed according to the actual application scenario, and the present invention does not limit it.

[0061] The distribution of the plurality of barbs can be uniformly arranged in a ring, and two adjacent barbs are connected to each other. The plurality of barbs can also be distributed at intervals, that is, a certain distance is between two adjacent barbs. The plurality of barbs can also be unevenly distributed, that is, the distance between any two adjacent barbs is not the same. The distribution of the plurality of barbs can be designed according to the actual application scenario, so that the valve stent 100 can be firmly and stably fixed on the aortic valve, so that the valve stent 100 will not fall from the aorta into the left ventricle.

[0062] Reference Figure 3 As shown, in some embodiments of the present invention, the anchor 400 can also be a radially outwardly bulging protrusion. The protrusion is provided on the outside of the valve stent 100, and the side surface of the protrusion is used to abut the inner wall of the aorta. Specifically, the protrusion can be "D"-shaped. The protrusion can be formed by a curved rod fixed separately on the outside of the valve stent 100 and enclosed by the outer wall of the valve stent, or it can be formed by the grid structure of the valve stent 100 protruding outward to form the above-mentioned protrusion. The protrusion can be evenly distributed along the circumference of the valve stent 100, or unevenly distributed. The protrusion can also be block-shaped or have other shapes. The specific shape of the protrusion is not limited by the present invention. The contact area between the protrusion and the interior of the aorta is relatively large, which can effectively fix the valve stent 100 and prevent the valve stent 100 from falling into the left ventricle. The protrusion and the barb can be provided alone or together, and both can be spaced apart along the circumference of the valve stent 100 to improve the installation stability of the valve stent 100.

[0063] Obviously, the above embodiments of the present invention are merely examples for the purpose of clearly illustrating the present invention and are not intended to limit the embodiments of the present invention. A person skilled in the art would be able to make various obvious changes, readjustments, and substitutions without departing from the scope of protection of the present invention. It is not necessary and impossible to enumerate all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the claims of the present invention.

Claims

1. An implantable aortic bioprosthesis, characterized in that: include: A valve stent (100), wherein the valve stent (100) is hollow inside and penetrates at both ends; An artificial valve (200) is arranged at a position corresponding to the cross section of the valve support (100), wherein the artificial valve (200) separates the valve support (100) into a first region (110) and a second region (120), wherein the first region (110) faces the blood outflow end of the aortic valve, and the second region (120) faces the blood inflow end of the aortic valve; The skirt (300) is an annular surface covering the second region (120), and the skirt (300) extends toward the blood inflow end of the aortic valve, and the outer wall of the skirt (300) is used to abut and seal with the leaflets of the aortic valve; as well as A plurality of anchoring members (400) are arranged in the first region (110) and are evenly or unevenly arranged along the circumference of the valve stent (100), wherein the anchoring members (400) have a protruding structure protruding from the surface of the first region (110) in the radial direction of the valve stent (100), and the protruding structure is used to abut against the inner wall of the aortic valve; The anchoring member (400) cooperates with the skirt (300) to fix the valve stent (100) on both sides of the aortic valve; The anchoring member (400) is a barb, one end of the barb is connected to the valve support (100), and the other end of the barb is inclined toward a side away from the valve support (100); or The anchoring member (400) is a protrusion that bulges radially outward; The skirt (300) has a first end and a second end, the first end faces the blood outflow end of the aortic valve, and the second end faces the blood inflow end of the aortic valve; in the axial direction of the valve support (100), the artificial valve (200) is located between the first end and the second end, and the axial dimension between the artificial valve (200) and the second end is greater than the axial dimension of the second region; The skirt (300) is in the shape of an annular thin sheet, and the outer diameter of the second end is greater than the outer diameter of the first end; The generatrix of the skirt (300) is a curve with continuously changing curvature; or The generatrix of the skirt (300) is a curve with an inflection point; The thickness of the valve support (100) is less than 0.6 mm; and / or The axial length of the valve support (100) is greater than 8 mm and less than 40 mm.

2. The implantable aortic bioprosthesis according to claim 1, wherein: The first end of the skirt (300) is sewn to the outside or inside of the valve support (100).

3. The implantable aortic bioprosthesis according to claim 1, wherein: The first end of the skirt (300) is a double-layer structure having an interlayer, and the valve stent (100) is inserted into and fixedly connected to the interlayer.

4. The implantable aortic bioprosthesis according to any one of claims 1 to 3, characterized in that: The skirt (300) is made of polyethylene terephthalate, polytetrafluoroethylene, bovine pericardium, or porcine pericardium.

5. An implantable aortic bioprosthesis, characterized in that: include: The valve support (100) is tubular and has a first end and a second end arranged opposite to each other in the axial direction; An artificial valve (200) is disposed in the inner cavity of the valve stent (100), wherein the artificial valve (200) divides the valve stent (100) into a first region (110) and a second region (120) arranged in sequence along the axial direction; A plurality of anchoring members (400) are arranged outside the first region (110) and are spaced apart along the circumference of the valve support (100); one end of each anchoring member (400) is connected to the valve support (100), and the other end extends in a direction away from the valve support (100); A skirt (300) covers the second region (120) and part of the first region (110), the skirt (300) having a first end and a second end arranged opposite to each other, the first end being located between the artificial valve (200) and the anchor (400), the second end extending beyond the second region (120), and the outer diameter of the second end being greater than the outer diameter of the first end; the anchor (400) having a protruding structure protruding from the surface of the first region (110) in the radial direction of the valve support (100), the protruding structure being used to abut against the interior of the aortic cavity to cooperate with the skirt (300) to fix the valve support (100) on both sides of the aortic valve; the skirt (300) is in the shape of an annular thin sheet, the outer diameter of the second end being greater than the outer diameter of the first end; the generatrix of the skirt (300) is a curve with a continuously changing curvature; or The generatrix of the skirt (300) is a curve with an inflection point.

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