Aortic valve stent and aortic valve device

Abstract

The invention discloses an aortic valve stent and an aortic valve device. The aortic valve stent is a self-expanding stent and comprises a stent body which is a tubular grid skeleton, and the end edge of the outflow end of the stent body comprises a plurality of edge grids and a plurality of grid notches which are distributed in a crossed mode in the circumferential direction; the outflow end release pieces are uniformly distributed at the outflow end of the stent main body in the circumferential direction and are correspondingly connected to the edge grids; the positioning pieces are evenly distributed at the outflow end of the support body in the circumferential direction and correspond to the grid notches, and the two ends of each positioning piece are connected to the two adjacent outflow end release pieces or the two edge grids; and in the direction from the outflow end to the inflow end of the opposite stent main body, the turning angle of the outflow end release piece or the edge grid to the connected positioning piece is an obtuse angle. By means of the mode, the aortic valve support can effectively reduce adverse effects generated by the outflow end of the aortic valve support.

Description

Technical Field

[0001] This application relates to the technical field of interventional treatment devices for heart valve diseases, and particularly to an aortic valve stent and an aortic valve device. Background Art

[0002] With the aging of the population, the incidence of valvular heart disease has increased significantly. In recent years, transcatheter valve implantation / repair has gradually matured and been widely used. In particular, the evidence-based medicine for transcatheter aortic valve implantation (TAVR / TAVI) is relatively sufficient, and the trauma has been greatly reduced, which is a milestone progress in the field of interventional treatment of heart valve diseases.

[0003] With the improvement of devices and the accumulation of experience, the TAVI technology has been continuously improved. Clinically, the artificial biological valves used in TAVI are mainly the balloon-expandable Edwards Sapien (Edwards Lifesciences, USA) and the self-expandable CoreValve (Medtronic, USA). The TAVI technology has made remarkable progress internationally and also has broad application prospects in China.

[0004] According to the data, the proportion of Asians with aortic valve regurgitation is higher than that of those with severe stenosis compared to Europeans and Americans. The balloon-expandable valves applicable to severe calcified stenosis are extremely demanding in terms of annulus area and calcification location selection. The self-expanding valves applicable to regurgitation have higher compliance on the annulus, which can reduce the uneven circular stress at the annulus level and may improve long-term hemodynamic outcomes. Currently, there are already four domestic aortic valves approved by China's CFDA for market launch, namely Venus A of MitralTech, J valve of Suzhou Jiecheng, VitaFlow of MicroPort CardioFlow, and TaurusElite of Shanghai MicroPort. However, no domestic enterprise has an absolute leading advantage. Although all are self-expanding stent designs, Venus A of MitralTech, VitaFlow of MicroPort CardioFlow, and TaurusElite of Shanghai MicroPort adopt the percutaneous approach, mainly to solve the problem of aortic valve stenosis, and there is no significant anchoring device design for the stent, relying only on the OVERSIZE of the main stent itself to fix the stent; the self-expanding stent design of J valve of Suzhou Jiecheng has three anchoring devices that can fix the stent at the bottom of the native leaflets to solve the problem of aortic regurgitation. However, the main valve product that has obtained the registration certificate uses the transapical approach, and the trauma of the transapical approach is greater than that of the percutaneous approach. Currently, the percutaneous approach product is still in the clinical stage and has not obtained the registration certificate. Its percutaneous approach product still uses the non-integrated cutting and separated anchoring device of the transapical approach. Currently, there are also two aortic valves for treating regurgitation through the percutaneous approach on the market, namely Trilogy of JenaValve, a company in cooperation with Shanghai MicroPort, and the PIONEER main valve of CoreValve. The two valve structural designs are similar, both with an anchoring structure with only a small opening angle formed by shaping and expanding on the integrated cutting structure, and the outflow end with a hollow design resulting in insufficient radial bearing capacity of the stent.

[0005] In summary, the currently marketed aortic valve products in China all have certain limitations in treating diseases or deficiencies in their own performance.

[0006] In the Chinese invention patent application with the application number 202210473085.X, a self-expanding percutaneous approach aortic valve device with integrated cutting, bilateral locking, and automatic capture of leaflets, which can treat both regurgitation and stenosis, is provided. It has structural features such as a stent body, a positioning member, a release member, and a T-shaped member, and can well meet the needs of patients. After a large number of confirmatory preclinical actual uses, technical problems are still found to have not been solved, including:

[0007] 1) Affect loading and release; The circumferentially continuous design of the diamond-shaped grid in the outflow end part makes the struts of the stent too dense. Coupled with the fact that the sewing has a certain leaflet closing effect also superimposed at this position, it makes the crimping size space limited and difficult to reduce, increasing the loading difficulty. Moreover, after loading, the friction value of the self-expanding valve itself will be large, and it is also very difficult during the release stage. There is a probability of not being able to release the valve, resulting in surgical failure and endangering the life of the patient.

[0008] 2) Increase the invasiveness of the device; To solve the problem of difficult loading and release, it is necessary to increase and improve the outer diameter size of the loading area of the delivery system, which will increase the invasiveness of the device and affect the proportion of percutaneous intervention for patients with small or fragile blood vessels.

[0009] 3) Cause leaflet wrinkles and damage; This structural design at the outflow end results in a small loading space, and the wrinkles and damage of the leaflets after compression are serious, limiting the service fatigue life. On the contrary, if the loading space is large, it is easier to screen the leaflet thickness and tend to the upper limit of the thickness, increasing the service life of the leaflets.

[0010] 4) Increase leaflet slapping against the wall; Although the outermost diamond grid at the outflow end is designed as an everted circumferentially continuous grid structure at a certain angle, there will still be the free edge of the sewn leaflet slapping against the struts of the metal grid. Over time, the free edge of the leaflet will cause serious damage, resulting in incomplete valve closure and new regurgitation, losing the therapeutic effect and increasing the patient's life safety risk.

[0011] 5) Affect the endothelialization process; The everted circumferentially continuous structure at the outflow end slows down the tissue endothelialization process after valve implantation and causes inflammation in the early stage.

[0012] 6) Pierce the tissue; The arc sharp corners of the diamond grid at the outflow end are more likely to pierce the aortic tissue during the manipulation of releasing into the sinus, causing inflammation and even serious hazards such as sudden drop in blood pressure and cardiac tamponade.

[0013] 7) Prone to block the coronary ostium; It is not suitable for patients with the coronary ostium close to the valve annulus. It is prone to block the coronary ostium, causing insufficient cardiac blood supply and oxygen supply, and in severe cases, it can develop into myocardial infarction and endanger life.

[0014] 8) Cause the positioning part and the grid arc sharp corners to entangle; This structural design at the outflow end increases the probability of the positioning part and the arc sharp corners of the diamond grid entangling with each other (the positioning part is caught inside the arc sharp corners). The binding force generated by the entanglement makes both the positioning part and the outflow end of the stent unable to expand freely, affecting valve deployment and morphological implantation.

[0015] 9) The positioning part is prone to breakage; The root of the positioning part is designed on different sides and needs to be shaped by flipping 180°, which is prone to breakage, resulting in anchor failure and valve position deviation, affecting the therapeutic effect of treating regurgitation.

[0016] 10) The positioning member is not easily inserted into the sinus; limited by the umbrella-shaped opening fracture and the large arc expansion fracture of the positioning member, the shape of the positioning member is single and it is not easily inserted into the sinus;

[0017] 11) More metal nickel ions are released; this structural design at the outflow end increases the mass ratio of the valve metal, and the metal here is exposed, so the release of nickel ions will relatively increase, and inflammatory problems such as sensitization will increase. Summary of the Invention

[0018] This application mainly provides an aortic valve stent and an aortic valve device to solve the problem that the existing aortic valve device has adverse effects during application due to the structural design of its outflow end.

[0019] To solve the above technical problems, a technical solution adopted in this application is: to provide an aortic valve stent. The aortic valve stent is a self-expanding stent, including: a stent body, which is a tubular grid framework, and the end edge of its outflow end includes a plurality of edge grids and a plurality of grid notches that are circumferentially cross-distributed; a plurality of outflow end release members, which are circumferentially and evenly distributed at the outflow end of the stent body and are correspondingly connected to the edge grids; a plurality of positioning members, which are circumferentially and evenly distributed at the outflow end of the stent body and are correspondingly arranged with the plurality of grid notches, and both ends of the positioning member are connected to two adjacent outflow end release members or two edge grids; wherein, in the direction from the outflow end to the inflow end of the opposite stent body, the turning angle from the outflow end release member or the edge grid to the connected positioning member is an obtuse angle.

[0020] In some embodiments, at least one layer of grid structure is missing at the grid notch relative to the edge grid.

[0021] In some embodiments, the grid notch is in an inverted pyramid shape and lacks at least two layers of grid structure compared to the edge grid.

[0022] In some embodiments, when the aortic valve stent is in a contracted state, the positioning member is received in the grid notch.

[0023] In some embodiments, the edge grid includes two first rib bars connected to each other, and the connection point of the two first rib bars is the grid vertex of the edge grid;

[0024] The outflow end release member includes two second rib bars connected to the grid vertices of two edge grids, and a lug connected to the other ends of the two second rib bars;

[0025] The end of the positioning member is connected to the member formed by the outer first rib bar and the second rib bar.

[0026] In some embodiments, the positioning member includes a U-shaped portion and two connecting arms bent and connected to both ends of the U-shaped portion. The U-shaped portion is unfolded in an umbrella shape relative to the stent body. The connecting arms are connected to the first rib or the second rib, and the turning angle is formed between the first rib or the second rib and the connecting arms.

[0027] In some embodiments, a cloth control member is provided at the bottom of the U-shaped portion and faces the outflow end.

[0028] In some embodiments, the cloth control member includes a silk thread connection hole for connecting an external cloth control silk thread.

[0029] In some embodiments, the cloth control member is also used for plugging and setting a sheath capillary outside the cloth control silk thread.

[0030] In some embodiments, the cloth control member includes a connecting arm and a connecting buckle connected to each other. The connecting arm is connected between the connecting buckle and the bottom of the U-shaped portion, and the connecting buckle is provided with a silk thread connection hole.

[0031] In some embodiments, the U-shaped portion includes a first folding sub-portion and a second folding sub-portion connected to each other. The first folding sub-portion and the second folding sub-portion are arranged in a folded manner. The U-shaped end of the second folding sub-portion is closer to the outflow end relative to the folding connection of the first folding sub-portion and the second folding sub-portion, and the U-shaped end of the second folding sub-portion serves as the cloth control member.

[0032] In some embodiments, when the second folding sub-portion is received in the grid notch, it does not extend beyond the outflow end.

[0033] To solve the above technical problems, another technical solution adopted by the present application is: to provide an aortic valve device. The aortic valve device includes the aortic valve stent as described above.

[0034] The beneficial effects of this application are as follows: Different from the prior art, this application discloses an aortic valve stent and an aortic valve device. By including a number of edge meshes and a number of mesh notches that are circumferentially cross-distributed at the outflow end of the stent body, that is, the outflow end of the aortic valve stent adopts a discontinuous hollowed-out mesh design, the effectiveness and reliability are improved during the valve loading and release processes. At the same time, the risks of valve leaflet wrinkles, wall-beating damage, entanglement of positioning parts and mesh vertices, piercing of tissue by mesh vertices, and inflammatory reactions can be reduced, effectively improving the service life of the aortic valve device and reducing the probability of clinical adverse events; further, a number of positioning parts are arranged corresponding to the mesh notches, and both ends of the positioning parts are connected to two adjacent outflow end release parts or two edge meshes. The turning angle from the outflow end release part or the edge mesh to the connected positioning part is an obtuse angle, that is, the smooth design on the same side of the positioning part ensures that the positioning part is not easily broken, improving the surgical safety and prognosis treatment effect. At the same time, the positioning part can achieve a large opening angle, large arc expansion, and silk wire layout, providing a favorable clinical effect guarantee for the aortic valve device to anchor physiological tissues and capture into the sinus. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings, where:

[0036] Figure 1 is a schematic structural diagram of an aortic valve device in the background art;

[0037] Figure 2 is as Figure 1 shown in the schematic structural diagram of the active valve stent in the aortic valve device;

[0038] Figure 3 is a schematic structural diagram of an embodiment of the aortic valve device provided by the present application;

[0039] Figure 4 is as Figure 3 shown in the schematic structural diagram of another embodiment of the active valve stent in the aortic valve device;

[0040] Figure 5 is as Figure 3 shown in the structural comparison schematic diagram of the positioning part in the aortic valve stent changed from non-smooth design on the same side (a) to smooth design on the same side (b);

[0041] Figure 6 is Figure 2Schematic diagram of the local structure of the aortic valve stent shown in the contracted state;

[0042] Figure 7 is Figure 5 Schematic diagram of the local structure of the aortic valve stent with ipsilateral smooth design shown in the contracted state;

[0043] Figure 8 is Figure 7 Schematic diagram of the structure of an embodiment of the aortic valve stent shown;

[0044] Figure 9 is Figure 7 Schematic diagram of the structure of another embodiment of the aortic valve stent shown;

[0045] Figure 10 is Figure 7 Schematic diagram of the structure of yet another embodiment of the aortic valve stent shown. Detailed implementation manners

[0046] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

[0047] The terms "first", "second", and "third" in the embodiments of the present application are only for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first", "second", and "third" may explicitly or implicitly include at least one of such features. In the description of the present application, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but optionally further includes steps or units not listed, or optionally further includes other steps or units inherent to these processes, methods, products, or devices.

[0048] Referring to "embodiment" herein means that a specific feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present application. The phrase appears in various places in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment mutually exclusive with other embodiments. Those skilled in the art will explicitly and implicitly understand that the embodiments described herein can be combined with other embodiments.

[0049] The human aortic valve is one of the four heart valves, located between the left ventricle and the aorta, responsible for ensuring the unidirectional flow of blood from the left ventricle to the aorta and preventing blood from flowing back. The aortic valve consists of three semilunar cusps (or leaflets).

[0050] Normally, the aortic valve has three cusps, each cusp is like a small pocket, and its edges will contact each other and form a seal when closed. Each cusp is composed of a thin and tough fibrous tissue, covered with endothelial cells on the surface. Inside the cusp, there are collagen fibers and elastic fibers, which endow the cusp with sufficient strength and elasticity to withstand the pressure changes during each heartbeat.

[0051] When the left ventricle contracts, the increased pressure pushes the cusps open, allowing blood to flow rapidly into the aorta. When the left ventricle relaxes, the pressure drops, and the cusps naturally close, preventing blood from flowing back from the aorta into the left ventricle and ensuring the effectiveness of blood circulation.

[0052] Specifically, during the systolic phase (systole) of the heart, the pressure in the left ventricle increases and exceeds the pressure in the aorta, causing the aortic valve cusps to be pushed open, and blood is rapidly ejected into the aorta. During the diastolic phase (diastole) of the heart, the pressure in the left ventricle drops, and the blood in the aorta attempts to flow back, which makes the cusps close tightly to prevent blood from flowing backward.

[0053] When valve diseases such as aortic stenosis or aortic regurgitation occur in the human aortic valve, it will be unable to perform its original function, and minimally invasive transcatheter aortic valve implantation (TAVI) can be used for treatment.

[0054] The core concept of TAVI is to deliver a new artificial aortic valve to the diseased location through a vascular path and deploy it in situ to replace the malfunctioning native valve. This process does not require open chest, so the trauma is small and the recovery is fast.

[0055] The main surgical instruments of TAVI include a delivery system and an aortic valve device 200. The delivery system is used to deliver the aortic valve device 200 to the treatment location through the vascular path determined by the guide wire, and then release the aortic valve device 200. After release, the aortic valve device 200 self-expands and captures the cusps into the sinus, closely adheres to and fixes at the native valve. The cusps on the aortic valve device 200 replace the function of the native valve and restore normal cardiac blood flow.

[0056] Before the aortic valve device 200 is installed in the delivery system and released, it is in a contracted state to reduce its volume for easy delivery along the vascular path. After being delivered to the treatment position and released, it can return to its normal state, self-expand and unfold between the left ventricle and the aorta, and the positioning members thereon capture the leaflets into the sinus, enabling the leaflets thereon to replace the native valve.

[0057] See Figure 1 and Figure 2 , Figure 1 are schematic structural diagrams of the aortic valve device in the background art. Figure 2 Such as Figure 1 is a schematic structural diagram of the active valve stent in the aortic valve device shown.

[0058] The aortic valve device 01 in the background art includes an aortic valve stent 02, a skirt 03 and leaflets 04. The skirt 03 is connected to the inner side of the aortic valve stent 02, and the leaflets 04 are connected to the inner side of the skirt 03. The outflow end 021 of the aortic valve stent 02 adopts a fully continuous grid structure design, and its positioning member 022 adopts a non-homolateral smooth design relative to the release member 023. The formed positioning member 022 needs to be turned outwards by nearly 180 degrees for heat setting, and the positioning member 022 needs to be turned back again and straightened along the axis of the aortic valve stent 02 during delivery. These design features result in some risks as described in the background art.

[0059] The present application provides an aortic valve device 200. See Figure 3 , Figure 3 is a schematic structural diagram of an embodiment of the aortic valve device provided by the present application.

[0060] The aortic valve device 200 includes an aortic valve stent 100, a skirt 210 and leaflets 220. The aortic valve stent 100 includes a stent body 10, a plurality of outflow end release members 20 and a plurality of positioning members 30. The skirt 210 is connected to the inner side of the stent body 10, and the leaflets 220 are connected to the inner side of the skirt 210. The leaflets 220 are configured to allow blood to flow from the inflow end 14 of the stent body 10 to its outflow end 11 and prevent blood from flowing from the outflow end 11 to the inflow end 14. A plurality of outflow end release members 20 connected to the stent body 10 are used to be traction-fixed in the delivery system and released controllably after being delivered to the treatment position, so that the aortic valve device 200 can be fixed at the treatment position. A plurality of positioning members 30 connected to the stent body 10 capture the leaflets into the sinus after release.

[0061] The human aortic valve leaflet is in the shape of a half bowl, forming a bowl pocket with the aortic sinus wall, with its tip facing downward and its mouth facing upward. The positioning member 30 enters the bowl pocket of the human aortic valve leaflet from above, and can slide down to the bottom along the structure of the valve sinus that is larger at the top and smaller at the bottom. It can be guided to accurately enter the valve leaflet bowl pocket, that is, capture the valve leaflet, through perspective and ultrasonic imaging. During the implantation process, the human body's own valve leaflet can be actively captured, providing accurate positioning for the doctor during the surgical operation, and can solve the problem of aortic valve stent fixation to avoid movement toward the ventricle.

[0062] The present application provides an aortic valve stent 100, in combination with Figures 3 to 5 ,in Figure 4 Yes Figure 3 The structure diagram of another embodiment of the active valve stent in the aortic valve device is shown in FIG. Figure 5 Yes Figure 3 Schematic diagram of structural comparison of the aortic valve stent shown in FIG. 1 , in which the positioning member in the aortic valve stent is changed from a non-ipsilateral smooth design (a) to an ipsilateral smooth design (b).

[0063] The aortic valve stent 100 is a self-expanding stent, which includes a stent body 10, a plurality of outflow end release pieces 20 and a plurality of positioning pieces 30. The stent body 10 is a tubular grid skeleton, and the end edge of the outflow end 11 thereof includes a plurality of edge grids 12 and a plurality of grid gaps 13 cross-distributed along the circumferential direction; the plurality of outflow end release pieces 20 are evenly distributed along the circumferential direction at the outflow end 11 of the stent body 10, and are correspondingly connected to the edge grids 12; the plurality of positioning pieces 30 are evenly distributed along the circumferential direction at the outflow end 11 of the stent body 10, and are correspondingly arranged to the plurality of grid gaps 13, and the two ends of the positioning piece 30 are connected to two adjacent outflow end release pieces 20 or two edge grids 12; wherein, in the direction A from the outflow end 11 to the inflow end 14 of the opposite stent body 10, the turning angle a1 from the outflow end release piece 20 or the edge grid 12 to the connected positioning piece 30 is an obtuse angle.

[0064] The aortic valve stent 100 is made of nickel-titanium alloy and is formed by laser cutting and heat setting. It is an integrated structure without any additional connection structure. In other words, the stent body 10 and the outflow end release members 20 and the positioning members 30 thereon are all formed by laser cutting.

[0065] like Figure 3 or Figure 4 As shown, the stent body 10 is a tubular grid skeleton, which includes an inflow end 14 and an outflow end 11, and its structure is mainly composed of ribs forming a diamond grid; Figures 6 to 10 As shown, when the aortic valve stent 100 is in a contracted state, the ribs constituting the diamond grid are close to each other, so that the grid is eliminated; Figure 3 or Figure 4As shown, after the aortic valve stent 100 is released, self-expansion causes the eliminated mesh to re-expand.

[0066] In this embodiment, Figure 3 or Figure 4 As shown, the outflow end 11 of the stent body 10 has three edge grids 12 and three grid gaps 13 cross-distributed along the circumferential direction, the number of the outflow end release pieces 20 and the number of the positioning pieces 30 are both three, the outflow end release pieces 20 are arranged corresponding to the edge grids 12 at each location, and the positioning pieces 30 are arranged corresponding to the grid gaps 13 at each location, that is, the outflow end release pieces 20 and the positioning pieces 30 are also cross-distributed.

[0067] Optionally, the number of edge grids 12 and grid gaps 13 is the same as the number of outflow end release members 20 and positioning members 30 , and may be more than two, such as four, five or six.

[0068] Combined with reference Figure 2 and Figure 3 , or see Figure 2 and Figure 4 The area spanned by both ends of the positioning member 30 corresponds to the grid gap 13, and the grid gap 13 is formed by eliminating the originally existing edge grid 12.

[0069] The positioning member 30 is an extension structure of the stent body 10 and is relatively located outside the stent body 10. After heat setting, it forms a U-shaped structure that bends downward and can be elastically folded. In this embodiment, when the aortic valve stent 100 is in a contracted state, the positioning members 30 are folded and accommodated in the grid gaps 13; and after the aortic valve stent 100 is released, each positioning member 30 can be controlled to be elastically folded, thereby capturing the valve leaflets into the sinus.

[0070] Optionally, when the aortic valve stent 100 is in a contracted state, each positioning member 30 can also be elastically folded to extend toward the outflow end 11 and to be retracted; and after the aortic valve stent 100 is released, each positioning member 30 rebounds and returns to its original state, thereby capturing the valve leaflets into the sinus.

[0071] In this embodiment, the grid structures on the bracket body 10 are all diamond grids, wherein the diamond grids located at the edge of the outflow end 11 are edge grids 12, and the grid gaps 13 lack part of the diamond grids relative to the edge grids 12, for example, lack at least one layer of grid structure or lack at least two layers of grid structure.

[0072] Alternatively, if Figure 3As shown, at the grid notch 13, the relative edge grid 12 lacks one layer of grid structure. That is, the upper half of the rib rods that originally formed the diamond grid at the grid notch 13 is cancelled, and the lower half of the rib rods that form the original diamond grid is retained, which is equivalent to eliminating one layer of diamond grid. The eliminated one layer of diamond grid may include two, three, four or other numbers of diamond grids.

[0073] Optionally, as Figure 4 shown, the grid notch 13 relative to the edge grid 12 lacks two layers of grid structure. The grid notch 13 is in an inverted pyramid shape, that is, all the rib rods that originally formed two layers of diamond grids at the grid notch 13 are cancelled except for the rib rods shared with the edge grid 12, which is equivalent to eliminating two layers of diamond grids. The eliminated two layers of diamond grids are in an inverted pyramid shape. For example, the upper layer of diamond grids includes three diamond grids, and the lower layer of diamond grids includes two diamond grids, which is determined by the grid structure characteristics of the stent body 10.

[0074] Optionally, the grid notch 13 relative to the edge grid 12 lacks three layers of grid structure. The grid notch 13 is in an inverted pyramid shape, that is, all the rib rods that originally formed three layers of diamond grids at the grid notch 13 are cancelled except for the rib rods shared with the edge grid 12, which is equivalent to eliminating three layers of diamond grids. For example, in the eliminated three - layer grid structure, the first layer includes three grid structures, the second layer includes two grid structures, and the third layer includes one grid structure.

[0075] In other embodiments, due to the different specifications of the stent body 10 and the diamond grids thereon, the sizes and shapes of the grid notch 13 and the edge grid 12 can be adaptively set to be different, and the present application does not make specific limitations on this.

[0076] Referring to Figure 2 、 Figure 5 and Figure 6 together, where Figure 5 is a schematic structural comparison diagram of the positioning member in the aortic valve stent changing from the non - same - side smooth design (a) to the same - side smooth design (b) as Figure 3 shown, Figure 6 and Figure 2 is a schematic partial structural diagram of the aortic valve stent in the contracted state as

[0077] In the existing aortic valve stent 02, a section of pipe is integrally cut by laser to form the stent body 024 and the positioning member 022. Its outflow end 021 adopts a circumferentially fully continuous grid design. Furthermore, the positioning member 022 can only be formed by cutting the pipe on the side of the outflow end 021 of the stent body 024 away from the inflow end 025, as Figure 5As shown, the turning angle formed between the end of the positioning member 022 and the outflow end release member 023 is an acute angle a2. At this time, the positioning member 022 is located on the side of the outflow end 021 away from the inflow end 025, and then the positioning member 022 formed by laser cutting needs to be turned nearly 180 degrees and then heat-formed to form a usable aortic valve stent 02. Because the turning angle of the positioning member 022 is too large and it is normally maintained in an open state after heat setting, the stress inside it causes the risk of the positioning member 022 breaking during use or after implantation in the body, which in turn causes the position of the anchoring failure valve to shift, affecting the treatment effect.

[0078] like Figure 6 As shown, the aortic valve stent 02 is in a contracted state when being transported, and the heat-set positioning piece 022 needs to be elastically flipped nearly 180 degrees again to stretch for easy transportation. In this process, the positioning piece 022 is folded once more, which further increases the risk of breakage.

[0079] Combined with reference Figure 4 , Figure 5 and Figure 7 ,in Figure 7 yes Figure 5 Shown is a schematic diagram of the local structure of an aortic valve stent with a same-side smooth design when it is in a contracted state.

[0080] In the present application, due to the presence of the grid gap 13, at least a portion of the positioning member 30 can be cut and formed using the material originally located at the grid gap 13, and then the positioning member 30 can form a same-side smooth design relative to the outflow end release member 20 and / or the edge grid 12, that is, the root of the positioning member 30 (the end of the positioning member 30) adopts a same-side smooth design, so that the positioning member 30 does not need to be turned nearly 180 degrees relative to each other during heat setting, but only needs to be stretched outward at a small acute angle, for example, the positioning member 30 is heat-set after being turned outward at an angle of less than 60 degrees. Therefore, after heat setting, the stress formed in the normalized open state maintained therein is greatly reduced compared with the implementation method of the prior art, and the risk of the positioning member 30 breaking is also greatly reduced, which can greatly eliminate the risk of position displacement of the valve causing anchor failure, ensure reliable treatment effect and greatly improve the performance of the device itself, and the service life is also improved.

[0081] In this embodiment, Figure 5 and Figure 7 As shown, in the direction A from the outflow end 11 to the inflow end 14 of the opposite bracket body 10, the turning angle a1 from the outflow end release piece 20 or the edge grid 12 to the connected positioning piece 30 is an obtuse angle, so that the end of the positioning piece 30 forms a same-side smooth design relative to the outflow end release piece 20 or the edge grid 12.

[0082] Optionally, both ends of the positioning member 30 are connected to two adjacent outflow-end release members 20 , and a turning angle a1 from the component of the outflow-end release member 20 to the connected positioning member 30 is an obtuse angle.

[0083] Optionally, two ends of the positioning member 30 are connected to two edge grids 12 separated by a grid gap 13, and a turning angle a1 from the ribs of the edge grid 12 to the connected positioning member 30 is an obtuse angle.

[0084] Compared with the aortic valve stent 02 in the prior art, the end of the positioning member 30 in the present application is connected to the outflow end release member 20 or the edge grid 12, and the turning angle a1 formed is an obtuse angle, so that the end of the positioning member 30 is designed to be smooth on the same side relative to the outflow end release member 20 or the edge grid 12, and the positioning member 30 can be formed by cutting the material originally located at the grid notch 12, see Figure 7 In this case, the positioning member 30 may be completely located in the grid gap 12 or at least partially located in the grid gap 12; see Figure 7 And contrast Figure 5 In (a) and (b), the positioning member 30 extends in the direction of the grid gap 12 relative to the outflow end release member 20, and the turning angle a1 is set to an obtuse angle. On the one hand, it is convenient for the positioning member 30 to be turned outward at a small angle during the subsequent heat setting, and on the other hand, it is possible to avoid the positioning member 30 causing an additional protrusion from the outflow end 11. Then, the positioning member 30 formed by cutting only needs to be turned outward at a small angle, which can be 15 to 60 degrees, and heat setting is performed to form a positioning member 30 that is normally opened at a certain angle relative to the bracket body 10.

[0085] In the present application, the positioning member 30 does not need to be flipped at a large angle for heat setting, but only needs to be everted at a small acute angle, and the end of the positioning member 30 forms a smooth design on the same side relative to the outflow end release member 20 or the edge grid 12. Therefore, the portion of the positioning member 30 protruding relative to the outflow end 11 is small and thin, which has less interference with the blood flow between the left ventricle and the aorta, and can reduce the risk of postoperative thrombosis. Furthermore, the outer dimensions formed by the positioning member 30 can be larger, so that the valve leaflets can be more easily captured into the sinus.

[0086] It has been verified by experiments, such as Figure 5 As shown, the waist dimension b2 of the positioning piece 022 in the aortic valve stent 02 in the prior art can reach 9 mm, and the waist dimension b1 of the positioning piece 30 in the aortic valve stent 100 of the same specification in the present application can reach 15 mm. The unfolded size structure of the positioning piece 30 in the present application is larger, which can be suitable for a wider group of people and can more easily capture the valve leaflets into the sinus.

[0087] In this embodiment, Figure 7As shown, the positioning member 30 is basically formed by cutting the material originally located at the grid notch 13. Therefore, when the aortic valve stent 100 is in a contracted state, the positioning member 30 can be received in the grid notch 13. Thus, the aortic valve stent 100 in the present application can relatively be formed by cutting a pipe with a shorter length, that is, the required material cost is lower.

[0088] When being transported by the delivery system, the aortic valve stent 100 is in a contracted state, and the positioning member 30 can be received in the grid notch 13. Compared with the aortic valve stents in the prior art, the aortic valve stent 100 provided in the present application requires a shorter length of delivery space. Moreover, the positioning member 30 does not need to be superimposed on the material of the stent main body 10. Therefore, the outer diameter of the aortic valve stent 100 in the contracted state is smaller, which is conducive to reducing the relevant components of the delivery system to be transported through thinner blood vessels. And this setting method of the positioning member 30 during transportation hardly increases the additional stress because it does not need to be flipped by nearly 180 degrees to be extended. Therefore, the fracture risk caused by keeping the positioning member 30 folded at a large angle for a long time is reduced.

[0089] Optionally, when being transported by the delivery system, the positioning member 30 on the aortic valve stent 100 may not be received in the grid notch 13, but is flipped by nearly 180 degrees and extends in the opposite direction of direction A.

[0090] In this embodiment, referring to Figure 5 the schematic diagram (b) in, the upper half structure of the edge grid 12 includes two first rib bars 121 connected to each other, and the connection point of the two first rib bars 121 is the grid vertex 120 of the edge grid 12; the outflow end release member 20 includes two second rib bars 21 connected to the grid vertices 120 of the two edge grids 12, and a lug 22 connected to the other ends of the two second rib bars 21; the end of the positioning member 30 is connected to the member formed by the outer first rib bar 121 and the second rib bar 21.

[0091] The two second rib bars 21 are connected to the grid vertices 120 of the two edge grids 12, thus forming a release grid 201, which can be used to sew part of the ends of the valve leaf 220; the lug 22 is used to connect to the delivery system. When the lug 22 is disconnected from the delivery system, the aortic valve stent 100 can expand outward by self-expansion.

[0092] In this embodiment, the two second rib rods 21 of the outflow end release member 20 are connected to two adjacent grid vertices 120, and the formed release grid 201 is also a rhombus grid, which has substantially the same structural dimensions as the edge grid 12. When the aortic valve stent 100 is in the deployed state, the first rib rod 121 and the second rib rod 21 are relatively inclined straight lines, and the end of the positioning member 30 can be connected to the straight member formed by the first rib rod 121 and the second rib rod 21.

[0093] Referring to Figure 5 and Figure 7 , from another perspective, the grid notch 13 and the space between two adjacent outflow end release members 20 together form a deep V-shaped space. The positioning member 30 in this application is formed by cutting the material originally existing in this deep V-shaped space. Therefore, when the two ends of the positioning member 30 are connected to the second rib rods 21 on two adjacent outflow end release members 20, the length of the positioning member 30 can be set relatively longer, and its set length can be guaranteed, so that the positioning member 30 is not easily broken. At the same time, the umbrella-shaped opening of the positioning member 30 is ensured, and the waist size of the positioning member 30 can be set larger to form a large arc expansion, which better exerts the functions of the positioning member 30 to anchor the valve and capture it into the sinus.

[0094] In this embodiment, as Figure 7 shown, the positioning member 30 includes a U-shaped portion 31 and two connecting arms 32 bent and connected to both ends of the U-shaped portion 31. The U-shaped portion 31 is unfolded in an umbrella shape relative to the stent body 10, and the connecting arms 32 are connected to the first rib rod 121 or the second rib rod 21, and a turning angle a1 is formed between the first rib rod 121 or the second rib rod 21 and the connecting arm 32.

[0095] The connecting arms 32 and the ends of the U-shaped portion 31 are also bent to facilitate the outward umbrella-shaped unfolding of the U-shaped portion 31; a turning angle a1 is formed between the connecting arms 32 and the first rib rod 121 or the second rib rod 21, and the turning angle a1 is an obtuse angle, that is, the connecting arms 32 extend toward the grid notch 13 direction, that is, the part of the positioning member 30 protruding from the outflow end 11 is extremely small. When the connecting arm 32 is connected to the first rib rod 121, it has no part protruding from the outflow end 11. Therefore, the part of the positioning member 30 protruding from the outflow end 11 is less, and the interference with the blood flow between the left ventricle and the aorta is smaller, which can reduce the risk of thrombosis formation after surgery.

[0096] Referring to Figure 8 , Figure 8 is Figure 7 the structural schematic diagram of an embodiment of the aortic valve stent shown. Further, a cloth control member 40 facing the outflow end 11 is provided at the bottom of the U-shaped portion 31. The cloth control member 40 is used to externally connect a cloth control silk thread, and the silk thread can apply a traction force to control the unfolding of the positioning member 30, thereby guiding the positioning member 30 to anchor the valve and capture it into the sinus.

[0097] A cloth control member 40 is provided at the center of the bottom of the U-shaped portion 31 and on the side facing the outflow end. The installation position of the cloth control member 40 can be sheltered by the U-shaped portion 31 to prevent it from scratching blood vessels or ventricles in the human body.

[0098] In the aortic valve stent in the prior art, if a cloth control member 40 as in the present application is provided on the positioning member, it is very likely that the blood vessels or ventricles in the human body will be scratched due to the cloth control member 40, resulting in serious medical accidents. Therefore, the cloth control member 40 cannot be installed thereon, and the expansion uncontrollability of its positioning member is poor and it is not easy to regulate, increasing the difficulty of the operation. In contrast, in the present application, due to the setting form of the positioning member 30, it is possible to install the cloth control member 40 on the positioning member 30, so that based on the cloth control member 40, the positioning member 30 can achieve a better function of accurately capturing into the sinus.

[0099] In this embodiment, the cloth control member 40 includes a silk thread connection hole 401 for connecting an external cloth control silk thread 101. During the operation, the cloth control silk thread 101 is passed through the silk thread connection hole 401 to establish a connection relationship with the cloth control member 40, and the attitude of the positioning member 30 is controlled by applying a traction force to the cloth control member 40, and the positioning member 30 can be controlled to flip, so as to accurately capture into the sinus and anchor the valve.

[0100] The cloth control member 40 includes a connecting arm 41 and a connecting buckle 42 connected to each other. The connecting arm 41 is connected between the connecting buckle 42 and the bottom of the U-shaped portion 31, and the connecting buckle 42 is provided with a silk thread connection hole 401.

[0101] Refer to Figure 9 , Figure 9 is Figure 7 The structural schematic diagram of another embodiment of the aortic valve stent shown in the figure. Further, the cloth control member 40 is also used for plugging and setting a sheath capillary 102 outside the cloth control silk thread 101. That is, the cloth control silk thread 101 is connected to the silk thread connection hole 401, the sheath capillary 102 is sleeved outside the cloth control silk thread 101 and one end is plugged into the cloth control member 40. Among them, the connecting arm 41 and the connecting buckle 42 can provide a longer plugging length for the sheath capillary 102 to improve the connection reliability. The sheath capillary 102 provides a protective effect for the cloth control thin wire 101 to prevent the cloth control silk thread 101 from cutting the tissues in the body and further reduce the risk during the operation.

[0102] After the positioning member 30 is controlled to accurately capture into the sinus, the cloth control silk thread can be detached from the silk thread connection hole 401, and the sheath capillary can also be detached from the cloth control member 40.

[0103] Optionally, the cloth control member 40 may also only include the connecting buckle 42 as described above, that is, the connecting buckle 42 is connected to the bottom of the U-shaped portion 31.

[0104] Optionally, the cloth control member 40 may also be in a T-shaped structure, and the cloth control wire is connected to the T-shaped structure.

[0105] Refer to Figure 10 , Figure 10 is Figure 7 a schematic structural diagram of another embodiment of the aortic valve stent shown in the figure. In another embodiment, the U-shaped portion 31 includes a first folding sub-portion 312 and a second folding sub-portion 314 that are connected to each other. The first folding sub-portion 312 and the second folding sub-portion 314 are arranged in a folded manner. The U-shaped end of the second folding sub-portion 314 is closer to the outflow end 11 relative to the folding connection of the first folding sub-portion 312 and the second folding sub-portion 314. The U-shaped end of the second folding sub-portion 314 serves as the cloth control member 40 as described above.

[0106] By setting the U-shaped portion 31 into the first folding sub-portion 312 and the second folding sub-portion 314 that are folded, and the U-shaped end of the folded second folding sub-portion 314 can be used as the cloth control member 40 as described above, it is possible to avoid setting an additional cloth control member 40. That is, the cloth control wire can pass through the U-shaped end of the second folding sub-portion 314, so that a force can be applied to the positioning member 40 for precise regulation, so as to achieve a better effect of precisely capturing into the sinus.

[0107] Furthermore, when the second folding sub-portion 314 is received in the grid notch 13, it does not extend beyond the outflow end 11 to eliminate the potential risk of thrombosis caused thereby, that is, the positioning member 30 can be wholly received in the grid notch 13.

[0108] In this embodiment, the first folding sub-portion 312 and the second folding sub-portion 314 are substantially of equal length, so that when the U-shaped end of the second folding sub-portion 314 is received in the grid notch 13, it can be substantially flush with the outflow end 11. Therefore, the connection point of the U-shaped end connecting the cloth control wire is equivalent to being flush with the outflow end 11, and the cloth control wire may not need to penetrate deeply into the area range of the grid notch 13 relatively. The regulation of the positioning member 30 can be achieved near the outflow end 11 relatively, reducing the risk of tissue damage caused by the cloth control wire.

[0109] In this application, the outflow end 11 of the stent body 10 includes a plurality of edge meshes 12 and a plurality of mesh notches 13 that are circumferentially cross-distributed. Compared with the circumferentially fully continuous mesh design used for the outflow end of the original stent body, in this application, some of the edge meshes 12 of the equivalent outflow end 11 are cancelled to form a plurality of mesh notches 13 isolated by the edge meshes 12. The outflow end 11 forms a circumferentially discontinuous mesh design, reducing the rib density of the outflow end 11. That is, when the specifications of the edge meshes 12 of the outflow end 11 remain unchanged, the number decreases, and thus the rib density of the edge meshes constituting the edge meshes also decreases. When the aortic valve device 200 is loaded onto the delivery system, the required loading space can also be reduced, the loading difficulty is decreased, and the problem of increased friction caused by loading of the self-expanding valve is effectively solved, enabling the valve to be reliably released, reducing the risk of surgical failure, and also facilitating the development of smaller-diameter delivery systems and expanding the patient population through smaller blood vessel paths.

[0110] By setting the outflow end 11 to include a plurality of edge meshes 12 and a plurality of mesh notches 13 that are circumferentially cross-distributed, it can adapt to a smaller loading space, so that the outer diameter size of the loading area of the delivery system does not need to increase but can instead be reduced and optimized, reducing the invasiveness of the instrument and effectively expanding the proportion of percutaneous interventions for patients with small or fragile blood vessels.

[0111] The required loading space for the outflow end 11 is relatively reduced, so that relatively more loading space can be reserved to accommodate the compressed leaflets 220, greatly solving the problem that the compressed leaflets 220 have a high risk of large wrinkles and damage due to the small loading space before. Relatively, it is easier to select the leaflets 220 closer to the thickness upper limit during leaflet thickness screening, and the service life of the leaflets 220 can be effectively increased.

[0112] The formed mesh notches 13 are equivalent to reducing some of the edge meshes 12 of the outflow end 11. Part of the leaflets 220 are sewn to the existing edge meshes 12 or in the release meshes 201 formed by the ribs of the edge meshes 12 and the outflow end release member 20. The mesh ribs that were originally easily slapped by the free ends of the leaflets 220 are in the area where the mesh notches 13 are located. Therefore, the situation of slapping between the mesh notches 13 and the free end edges of the leaflets 220 is eliminated, eliminating an adverse factor causing damage to the free end edges of the leaflets 220, reducing the risk of damage to the free ends of the leaflets 220, avoiding regurgitation caused by incomplete valve closure due to damage to their free ends, effectively improving the treatment effect of the aortic valve device 200, and also improving its service life.

[0113] Furthermore, since the outflow end 11 reduces some of the edge meshes 12 to form mesh gaps 13, the number of edge mesh ribs 12 that need to be covered during the endothelialization process is reduced, which is beneficial to the endothelialization process of the tissue after valve implantation, and the inflammatory impact caused is also reduced.

[0114] Due to the setting of several mesh gaps 13, the number of edge meshes 13 and their mesh vertices is relatively reduced. Therefore, during the manipulation of releasing into the sinus, the risk of the mesh vertices at the outflow end 11 piercing the aortic tissue can be effectively reduced, improving the surgical safety.

[0115] Several mesh gaps 13 also appropriately reduce the circumferential support of the outflow end 11. In patients with the coronary artery orifice close to the valve annulus, the outflow end 11 can appropriately contract under pressure to avoid blocking the coronary artery orifice. Therefore, the aortic valve device 200 provided in this application can be applicable to patients with the coronary artery orifice close to the valve annulus.

[0116] Since the regions spanned by both ends of the positioning member 30 correspond to the mesh gaps 13, the mesh vertices at the mesh gaps 13 sink relative to the mesh vertices of the edge meshes 12, thereby avoiding entanglement with the positioning member 20 and ensuring that the positioning member 30 can be freely deployed after release, so that the valve layout and morphological implantation are not affected.

[0117] Since the outflow end 11 is provided with several mesh gaps 13, the proportion of the valve metal mass of the outflow end 11 is greatly reduced. Therefore, the release of metal ions such as nickel can be effectively reduced, and the risk of inflammatory problems such as metal ion sensitization can be reduced.

[0118] The positioning member 30 is designed with a smooth same-side design between the edge meshes 12 and the outflow end release member 20, and its length can be guaranteed, that is, its length space is improved, so that the positioning member 30 is not easily broken, and the fracture risk is effectively controlled. At the same time, the umbrella-shaped opening and large arc expansion of the positioning member 30 are ensured, so that its functions of anchoring the valve and capturing into the sinus can be better exerted.

[0119] In this application, the outflow end 11 of the aortic valve stent 100 adopts a discontinuous hollowed-out mesh design, which improves the effectiveness and reliability during the valve loading and release process. At the same time, the risks of valve leaflet folds, wall-beating damage, entanglement between the positioning member 30 and the mesh vertices 120, piercing of the mesh vertices 120 into the tissue, and inflammatory reactions can be reduced, effectively improving the service life of the aortic valve device 200 and reducing the probability of clinical adverse events.

[0120] The outflow end 11 of the aortic valve stent 100 adopts a discontinuous hollowed-out grid design, which provides a broad space for the ipsilateral smooth design, shape and size design of the positioning member 30. The ipsilateral smooth design of the positioning member 30 ensures that the positioning member 30 is not easily broken, improves the surgical safety and prognosis treatment effect. At the same time, the positioning member 30 can achieve a large opening angle, large arc expansion and wire layout, providing a favorable clinical effect guarantee for the aortic valve device 200 to anchor physiological tissues and capture into the sinus.

[0121] The above are only the embodiments of the present application, and thus do not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made by using the content of the specification and drawings of the present application, or directly or indirectly applied in other related technical fields, shall be similarly included in the patent protection scope of the present application.

Claims

1. An aortic valve stent, which is a self-expanding stent, characterized in that: include: The stent body is a tubular grid skeleton, and the end edge of the outflow end includes a plurality of edge grids and a plurality of grid gaps cross-distributed along the circumferential direction; A plurality of outflow end release members are evenly distributed along the circumference at the outflow end of the stent body and are correspondingly connected to the edge grid; A plurality of positioning members are evenly distributed along the circumferential direction at the outflow end of the stent body and are arranged corresponding to the plurality of grid gaps, and two ends of the positioning members are connected to two adjacent outflow end release members or two edge grids; Wherein, in the direction from the outflow end to the inflow end of the opposite support body, the turning angle from the outflow end release piece or the edge grid to the connected positioning piece is an obtuse angle.

2. The aortic valve stent according to claim 1, characterized in that: The grid gap lacks at least one layer of grid structure relative to the edge grid.

3. The aortic valve stent according to claim 2, characterized in that: The grid gap is in an inverted pyramid shape and lacks at least two layers of grid structure compared to the edge grid.

4. The aortic valve stent according to any one of claims 1 to 3, characterized in that: When the aortic valve stent is in a contracted state, the positioning member is accommodated in the grid gap.

5. The aortic valve stent according to claim 1, characterized in that: The edge mesh includes two first ribs connected to each other, and the connection point of the two first ribs is a mesh vertex of the edge mesh; The outflow end release member includes two second ribs connected to the grid vertices of the two edge grids, and a hanging ear connected to the other ends of the two second ribs; The end of the positioning member is connected to a component formed by the first rib and the second rib on the outside.

6. The aortic valve stent according to claim 5, characterized in that: The positioning member includes a U-shaped portion and two connecting arms bent and connected to the two ends of the U-shaped portion, the U-shaped portion is unfolded in an umbrella shape relative to the bracket body, the connecting arm is connected to the first rib or the second rib, and the turning angle is formed between the first rib or the second rib and the connecting arm.

7. The aortic valve stent according to claim 6, characterized in that: The bottom of the U-shaped portion is provided with a cloth control portion facing the outflow end.

8. The aortic valve stent according to claim 7, characterized in that: The cloth control unit includes a wire connection hole, and the wire connection hole is used to connect an external cloth control wire.

9. The aortic valve stent according to claim 8, characterized in that: The cloth control unit is also used for plugging a sheath tube arranged outside the cloth control wire.

10. The aortic valve stent according to claim 9, characterized in that: The cloth control comprises a supporting arm and a connecting buckle connected to each other, the supporting arm is connected between the connecting buckle and the bottom of the U-shaped portion, and a thread connecting hole is provided on the connecting buckle.

11. The aortic valve stent according to claim 6, characterized in that: The U-shaped portion includes a first folding sub-portion and a second folding sub-portion connected to each other, wherein the first folding sub-portion and the second folding sub-portion are folded, and the U-shaped end of the second folding sub-portion is close to the outflow end relative to the folded connection between the first folding sub-portion and the second folding sub-portion, and the U-shaped end of the second folding sub-portion serves as a cloth control.

12. The aortic valve stent according to claim 11, characterized in that: The second folded sub-portion does not extend beyond the outflow end when accommodated in the grid gap.

13. An aortic valve device, characterized in that: Comprising the aortic valve stent according to any one of claims 1 to 12.

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