Transcatheter aortic valve replacement device with bilateral locking function

Abstract

The transcatheter aortic valve replacement device with bilateral locking function includes a self-expanding stent (10), a skirt portion (20), valve leaflets (30), a resilient positioning member (40), and an outflow end release member (50), wherein a through hole is defined inside the self-expanding stent (10), the self-expanding stent (10) has an inflow end (1a) and an outflow end (1b), the sidewall of the self-expanding stent (10) is a mesh structure, the skirt portion (20) is connected to the sidewall of the through hole, and the valve leaflets (30) are connected to the skirt portion (20) through the sidewall of the through hole. The sidewall connected to the inside and adjacent to the outflow end (1b) of the self-expanding stent (10) is defined by a plurality of outflow end meshes (11), the elastic positioning member (40) has a U-shaped portion (41) and connection arms (42) located at both ends of the U-shaped portion (41), the connection arms (42) are connected to the self-expanding stent (10) or the outflow end release member (50) to form a first connection point (L1), and the outflow end release member (50) is connected to the self-expanding stent (10) to form a second connection point (L2). The two functions of positioning the self-expanding stent (10) and releasing the outflow end (1b) are separated, independent of each other, and do not affect each other, so that the accurate positioning and installation of the self-expanding stent (10) can be effectively ensured.

Description

[Technical field]

[0001] The present invention relates to the technical field of structural design of artificial heart valve intervention devices, in particular to a transcatheter aortic valve replacement device with bilateral locking function. [Background technology]

[0002] With the aging of the human population, the incidence of valvular heart disease has obviously increased. At present, traditional surgical treatment is still the first-choice treatment for many patients with severe valvular disease, but it has the risks of large wounds, high postoperative mortality, and high complications. In recent years, transcatheter valve implantation / repair has gradually matured and been widely applied, especially transcatheter aortic valve implantation (TAVR / TAVI), which has sufficient evidence-based medical evidence, significantly reduced wounds, and has been recommended by the European and American Heart Valve Disease Treatment Guide, which is a milestone development in the field of heart valve disease intervention treatment.

[0003] Transcatheter aortic valve implantation (TAVI) is a new technique for implanting an artificial aortic valve using an interventional method. It was first reported by Dr. Criber of France in 2002, bringing hope to the treatment of patients with severe aortic stenosis (AS) who lost the opportunity for surgery (e.g., >80 years old), and adding a new page to the history of interventional treatment of cardiovascular disease. Over the next 10 years, with the improvement of equipment and the accumulation of experience, the TAVI technique has been perfected and has been continuously performed in 500 cardiac centers in about 40 countries, with a total number of surgeries exceeding 150,000. In particular, after a series of registration studies and randomized controlled studies have confirmed its efficacy, feasibility and safety, the TAVI technique has become the first-choice treatment method for severe AS patients who cannot undergo surgical valve replacement. In clinical practice, there are two types of artificial biological valves used in TAVI: Edwards Sapien (Edwards, USA), which is implanted by balloon expansion, and CoreValve (Medtronic, USA), which is implanted by self-inflation. TAVI technology has already made remarkable progress internationally, and has already been applied in China to a preliminary extent, and has a similarly broad future. At present, the domestic heart valve device market in China is highly monopolized by foreign brands, with foreign companies such as Edwards Lifesciences, Medtronic, LivaNova (already acquired by Sorin), St. Jude Medical (already acquired by Abbott) and On-X occupying about 85% of the market share. Edwards Lifesciences and Medtronic have a full product line from mechanical valves and biological valves to transcatheter interventional valves, and domestic device companies have also appeared in China. Currently, three domestic transcatheter aortic valves have been approved by the Chinese CFDA and are on the market, namely, Qiming Medical's Venus-A, Suzhou Jiecheng's J-valve, and Weichuang Xintong's VitaFlow. However, there is still no company with absolute advantage among domestic companies in China.

[0004] According to the statistical analysis of the hospital patient ultrasound electrocardiogram database, in patients aged 65-74 (49995 cases) and ≥ 75 years (34671 cases), the detection rates of moderate or severe aortic regurgitation (AR) were 2.12% and 2.85%, respectively, and the detection rates of moderate or severe aortic stenosis (AS) were 0.75% and 0.89%, respectively, and the detection rates of severe aortic regurgitation (SAR) and severe aortic stenosis (SAS) in the two sets of patients were 0.52% VS 0.95%, 0.54% VS 0.57%, respectively. It can be seen that Chinese elderly people tend to suffer from aortic regurgitation in aortic valve degenerative lesions. There is a certain difference between Chinese patients with aortic valve disease and patients in Western countries. (1) The proportion of Chinese patients with bicuspid aortic valves is high, at 40%-50%, much higher than the 1.6%-9.3% of patients in Western countries, and bicuspid aortic valves are used as the exclusion criterion in many large-scale TAVR clinical studies in Western countries. (2) The aortic valves of Chinese patients have a high degree of calcification. (3) Aortic regurgitation is more common than aortic stenosis in Chinese patients. (4) The femoral artery internal diameter is small, with the average femoral artery internal diameter of 6.5 mm in Chinese TAVR candidate cases.

[0005] Qiming Medical's Venus-A and Weichuang XinTong's VitaFlow use the percutaneous route and the design of a self-expanding stent, mainly solving the problem of aortic valve stenosis, while Suzhou Jiecheng's J-valve uses the design of a self-expanding stent and has three anchor devices to fix the stent to the base of its own valve cusp, solving the problem of aortic regurgitation, but uses the transapical route, and the wound of the transapical route is larger than that of the percutaneous route. At the same time, the valve membrane of Qiming Medical's Venus-A and Suzhou Jiecheng's J-valve products uses porcine pericardium, while Weichuang XinTong's VitaFlow uses bovine pericardium, and the durability of bovine pericardium is superior to that of porcine pericardium. In summary, the three aortic valve products currently on the market in China all have certain limitations in disease treatment or their own performance deficiencies.

[0006] In a Chinese invention patent application bearing application number 2021107458307, a transcatheter aortic valve device for automatically capturing valve leaflets is provided, the device having a stent, a skirt portion, and a positioning member, the positioning member being an extension portion of the stent, and the connection point between the positioning member and the stent is also a release structure of the stent. In actual use, the connection point between the stent and the positioning member needs to be used to release the stent. It was found that in the clinical operation process, when the above technology is used, the connection point between the stent and the positioning member will affect the positioning of the positioning member when the stent is released, resulting in inaccurate positioning of the device, resulting in poor post-operative results, and in serious cases, even threatening the patient's life. It was also found that the blood and cardiac tissues will exert a large acting force on the stent, causing a relative displacement between the stent and the positioning member, which will cause the positioning member to be pulled and affect the service life of the positioning member. Summary of the Invention [Problem to be solved by the invention]

[0007] Based on the above circumstances, the present invention provides a transcatheter aortic valve replacement device with bilateral locking function to solve the technical problem that the structural design of aortic valve products in the prior art is unreasonable, which affects the positioning of the positioning member during the stent release process, and leads to inaccurate positioning of the device. [Means for solving the problem]

[0008] The technical means by which the present invention solves the above technical problems are as follows.

[0009] A transcatheter aortic valve replacement device having a bilateral locking function includes a self-expanding stent, a skirt, a valve leaflet, at least two resilient positioning members, an outflow end release member, and an inflow end release member, A through hole is defined inside the self-expanding stent through which a liquid flows, the self-expanding stent has an inflow end corresponding to the through hole and an outflow end opposite the inflow end, the side wall of the self-expanding stent has a mesh structure, the skirt portion is connected to the side wall of the through hole, the valve leaflets are connected to the inside of the skirt portion, and the side wall adjacent to the outflow end of the self-expanding stent is defined by a plurality of outflow end meshes arranged in a ring shape, The elastic positioning member has a U-shaped portion and connecting arms located at both ends of the U-shaped portion, the connecting arms are connected to the outflow end, the U-shaped portion is located outside the self-expanding stent, and the central portion of the U-shaped portion extends toward the inflow end and can be elastically folded back; The outflow end release member is connected to the outflow end of the self-expanding stent and is located between two of the elastic positioning members, and the inflow end release member is connected to the inflow end of the self-expanding stent.

[0010] Compared with the prior art, the technical solutions of the present application have the following beneficial technical effects:

[0011] In the transcatheter aortic valve replacement device according to the present application, the stent is provided with an elastic positioning member and an outflow end release member, which separates the two functions of stent positioning and outflow end release, making them independent of each other and not affecting each other, effectively preventing the stent from affecting the positioning member and thus affecting the effective installation of the entire self-expanding stent when it is released by the outflow end release member. In addition, the outflow end release member is mounted between the elastic positioning members, which effectively ensures the compactness and stability of the structure of the entire device, and the outflow end release member and the inflow end release member can form a bilateral fixed structure with the delivery system, making it easy to install inside the delivery system.

[0012] Based on the above technical means, the present invention can be improved as follows.

[0013] Furthermore, the connection arm is connected to the outflow end mesh or the outflow end release member to form a first connection point, and the outflow end release member is connected to the outflow end mesh to form a second connection point, and at least one of the first connection point and the second connection point is offset from a vertex of the outflow end mesh.

[0014] By using the above technical means to separate and remove either the first connection point or the second connection point from the apex of the outflow end mesh, the relative displacement force experienced by the connection point between the elastic positioning member and the self-expanding stent can be effectively distributed, and the elastic positioning member can be effectively protected from breakage.

[0015] Furthermore, the angle between the connecting arm and the corresponding tangent plane of the outflow end mesh is in the range of 0 to 45°.

[0016] Furthermore, the connecting arms lie in a plane tangent to the corresponding outflow end mesh.

[0017] By using the above technical means, the radial pressure received by the elastic positioning member is effectively distributed to the self-expanding stent, and the self-expanding stent receives the radial force, thereby offsetting the radial force received by the positioning member.

[0018] Furthermore, the number of the elastic positioning members is three, and the three elastic positioning members are uniformly distributed along the circumferential direction of the self-expanding stent.

[0019] Furthermore, a repair portion is formed adjacent both ends of the U-shaped portion, and the transcatheter aortic valve replacement device further includes a repair member, and the repair portion is connected to the self-expanding stent via the repair member.

[0020] Furthermore, the repair part and the first connection point are located at both ends of the connection arm, the repair member is a soft sheet-like structure, the repair member can encase or wrap around the connection arm along the length of the connection arm, and both ends of the repair member corresponding to the connection arm are fixed to the corresponding first connection point and the repair part.

[0021] Using the above technical means, the repair member can be wrapped around the connecting arm and fixed to further reinforce the connection between the connecting arm and the self-expanding stent and the U-shaped portion, and when any end of the elastic positioning member detaches from the expanding stent, the repair member can limit the elastic positioning member from causing further damage to the patient's body.

[0022] Furthermore, the repair member is a thin elongated structure and is one in number, and one end of the repair member passes through all of the repair sections in sequence and is connected to the self-expanding stent.

[0023] Furthermore, the repair members are thin, elongated structures and their number is equal to the number of the elastic positioning members, and one end of each of the repair members passes through the repair portions in the same U-shaped portion in sequence and is connected to the self-expanding stent.

[0024] By using the above technical means, when the elastic positioning member falls off or the connection is unstable, the connection relationship between the elastic positioning member and the self-expanding stent can be timely restored by the repair member, thereby preventing further damage to the patient's body.

[0025] Additionally, the transcatheter aortic valve replacement device further includes a protective member, which is connected to the outside of the central portion of the U-shaped portion by suturing, wrapping or wrapping.

[0026] Furthermore, the repair member and the protective member are made of polyester fabric or bovine pericardium.

[0027] By using the above technical means, the U-shaped portion effectively prevents the wrapping of the protective member from damaging the cardiac tissue or the blood vessel wall during use.

[0028] Further, the outflow end release member includes a release portion and support arms located on both sides of the release portion, the second connection point connects the support arms and the self-expanding stent, the two second connection points of the same outflow end release member are located on the tops of different outflow end meshes, and the release portions extend in a direction away from the outflow end along a first direction.

[0029] By using the above technical means, the outflow end release member and the elastic positioning member respectively extend in two directions, so that the influence of each other is further reduced.

[0030] Furthermore, a release mesh is defined between the support arm of each of the outflow end release members and the outside of the two adjacent outflow end meshes, and one end adjacent to the inflow end of the valve leaflet and the skirt portion are sewn together circumferentially, and the connection point between the other end and the skirt portion is located inside the release mesh.

[0031] By using the above technical means, an open mesh is defined between the support arm and the outside of the two adjacent outflow end meshes, and the connection point between one end adjacent to the outflow end of the valve leaflet and the skirt portion is located inside the open mesh, so that the size of the open mesh is much larger than the available position of the connection point in the prior art, making the adhesion between the valve leaflet and the skirt portion more convenient and strong, and extending the service life of the device.

[0032] Furthermore, the hole diameter of the through hole gradually decreases along a first direction and then remains unchanged or gradually increases, and the release mesh curves inwardly of the through hole along the first direction.

[0033] Furthermore, the elastic positioning member and the self-expanding stent are cut as one piece from a nickel-titanium alloy tube and then heat-set.

[0034] Using the above technical means, the stability of the structural connection between the self-expanding stent and the elastic positioning member is effectively guaranteed.

[0035] Further, the sidewall adjacent the inflow end of the self-expanding stent is defined by a plurality of inflow end meshes arranged in a ring shape, and the inflow end release member includes an elliptical structure connected to the vertices of the inflow end meshes.

[0036] Using the above technical means, the elliptical structure has no sharp edges and its outer surface is a smooth curved surface, so that the movement space of the inflow end release member is small and damage to the blood vessel wall is prevented.

[0037] Furthermore, the center of the elliptical structure has a through hole formed along the radial direction of the through hole.

[0038] By using the above technical means, the entire elliptical structure is circular, and compared with a solid elliptical structure, the entire structure is soft and less likely to damage the organ tissues of the human body.

[0039] Furthermore, an extension line of the short axis of the elliptical structure is parallel to the axis of the through hole, and an extension line of the long axis of the elliptical structure is located on a tangent plane of the corresponding inflow end mesh.

[0040] By using the above technical means, the inflow end mesh has a vertical squeeze design at the apex, which can effectively prevent the aortic vessel wall from being damaged during the installation of the stent. [Brief description of the drawings]

[0041] [Figure 1] FIG. 1 is a perspective view of a transcatheter aortic valve replacement device with bilateral locking in accordance with an embodiment of the present invention. [Diagram 2] FIG. 2 is a schematic diagram of the structure in which the skirt portion and the valve cusps in FIG. 1 are hidden. [Diagram 3] 13 is a schematic diagram of an overlapping connection structure of a first connection point, a second connection point, and an outflow end mesh vertex. FIG. [Figure 4]FIG. 2 is a structural schematic diagram of a first staggered embodiment of the present invention; [Diagram 5] FIG. 2 is a structural schematic diagram of a second staggered embodiment of the present invention; [Figure 6] FIG. 2 is a plan view showing the support arms and the self-expanding stent forming an angle. [Figure 7] FIG. 13 is a plan view of the support arms contacting a self-expanding stent. [Figure 8] FIG. 6 is a structural schematic diagram of another embodiment having a repair portion in comparison with FIG. 5; [Figure 9] FIG. 4 is a structural schematic diagram of a repair part in another embodiment of the present invention. [Figure 10] FIG. 2 is a schematic diagram of a compression structure according to an embodiment of the present application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0042] In order to facilitate an understanding of the present application, the present application will now be described more fully with reference to the associated drawings, in which examples of the present application are shown, but which may be embodied in many different forms and are not limited to the examples set forth herein. On the contrary, the purpose of providing these examples is to provide a more complete and thorough understanding of the present disclosure.

[0043] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terms used herein in the description of this application are for the purpose of describing specific examples only and are not intended to be limiting of the application.

[0044] As shown in FIG. 1, the present application provides a transcatheter aortic valve replacement device with bilateral locking function, which includes a self-expanding stent 10, a skirt 20, valve leaflets 30, at least two elastic positioning members 40, and at least two outflow end release members 50.

[0045] In this embodiment, a through hole through which a liquid (e.g., blood) flows is defined inside the self-expanding stent 10, the self-expanding stent 10 has an inflow end 1a and an outflow end 1b opposite the inflow end 1a corresponding to the through hole, the side wall of the self-expanding stent 10 has a mesh structure, the skirt portion 20 is connected to the side wall of the through hole, and the valve cusp 30 is connected to the inside of the skirt portion 20, as shown in FIG. 2, the valve cusp 30 is configured to allow blood to pass through the through hole along a first direction A in which blood flows from the inflow end 1a to the outflow end 1b, and to prevent blood from passing through the through hole along a second direction B opposite to the first direction A, the side wall adjacent to the inflow end 1a of the self-expanding stent 10 is defined by a plurality of inflow end meshes 11 arranged in a ring shape, and the side wall adjacent to the outflow end 1b of the self-expanding stent 10 is defined by a plurality of outflow end meshes 12 arranged in a ring shape.

[0046] As shown in Fig. 2, the elastic positioning member 40 has a U-shaped portion 41 and connecting arms 42 located at both ends of the U-shaped portion 41, the U-shaped portion 41 is located outside the self-expanding stent 10, and the center portion of the U-shaped portion 41 extends toward the inflow end 1a and can be elastically folded back. As is well known, the self-expanding stent 10 needs to be compressed during the process of being delivered to the human body, and as shown in Fig. 10, the U-shaped portion 41 can be elastically folded back and extended toward the outflow end.

[0047] The outflow end release member 50 is connected to the outflow end 1b of the self-expanding stent 10 and is located between the two elastic positioning members 40, the connecting arm 42 is connected to the outflow end mesh 12 or the outflow end release member 50 to form a first connection point L1, and the outflow end release member 50 is connected to the outflow end mesh 12 to form a second connection point L2.

[0048] In this embodiment, the two functions of elastic positioning of the self-expanding stent 10 and releasing of the outflow end mesh 12 are separated and made independent of each other, without affecting each other, effectively avoiding the self-expanding stent 10 affecting the positioning and mounting of the elastic positioning member 40 during the outflow end releasing process, which causes the heart valve to be inaccurately positioned. In addition, the outflow end releasing member 50 is mounted between the elastic positioning members 40, which effectively ensures the compactness and stability of the structure of the entire device.

[0049] In the present application, the outflow end release member 50 includes a release portion 51 and support arms 52 located on both sides of the release portion, and the second connection point L2 connects the support arm 52 to the self-expanding stent 10, and the two second connection points L2 of the same outflow end release member 50 are located on the tops of different outflow end meshes 12, and the release portion 41 extends in a direction away from the outflow end 1b along the first direction.

[0050] The outflow end release member 50 can be considered as a part extending from or connected to the self-expanding stent 10, and the elastic positioning member 40 may be connected to the outflow end mesh 12 of the self-expanding stent 10 or to two support arms 52.

[0051] The release portion 51 is connected to a delivery system that delivers the valve device into the human body. When the connection between the release portion 51 and the delivery system is cut off, the outflow end release member 50 expands outward through the self-expanding stent 10, thereby realizing the release of the outflow end 1b. After the installation is completed, the outflow end release member 50 and the elastic positioning member 40 extend in two directions respectively, thereby further reducing the influence of each other.

[0052] More preferably, a release mesh 53 is defined between the support arm 52 of each outflow end release member 50 and the outer side of the two adjacent outflow end meshes 12, one end adjacent to the inflow end 1a of the valve leaflet 30 and the skirt portion 20 are sewn together along the circumferential direction, and the connection point between the other end and the skirt portion 20 is located inside the release mesh 53. By defining the release mesh 53 between the support arm 52 and the outer side of the two adjacent outflow end meshes 12 and providing the connection point between the one end adjacent to the outflow end mesh 12 of the valve leaflet 30 and the skirt portion 20 inside the release mesh 53, the size of the release mesh 53 is much larger than the available position of the connection point in the prior art, making the adhesion between the valve leaflet 30 and the skirt portion 20 more convenient and firm, and prolonging the service life of the heart valve device.

[0053] The most obvious and conceivable method of connecting the elastic positioning member 40 and the outflow end release member 50 is for the first connection point L1 and the second connection point L2 to both be connected to the vertices of the outflow end mesh 12, as shown in Figures 2 and 3.

[0054] As a result of analyzing and studying the stress conditions during use of the transcatheter aortic valve replacement device, the outer walls of the self-expanding stent 10 and the elastic positioning member 40 are both in contact with the cardiac tissue during use, and the elastic positioning member 40 must first receive pressure from the cardiac tissue along the radial direction of the self-expanding stent 10. At the same time, frictional force is generated when blood flows inside the through-hole, and the blood pressure is not uniform, so that a vortex flow rotational action force is generated, which causes a relative rotation tendency between the self-expanding stent 10 and the elastic positioning member 40, generating a rotational tensile force. In addition, since the connection point between one end of the valve leaflet 30 adjacent to the outflow end mesh 12 and the skirt portion 20 is provided inside the release mesh 53, when blood flows through the through-hole, the valve leaflet 30 periodically opens and closes, and the area near the outflow end mesh 12 periodically oscillates, generating a periodic oscillating tensile force on the elastic positioning member 40. When the first connection point L1, the second connection point L2 and the vertices of the outflow end mesh 12 overlap, the above-mentioned several acting forces all act on the elastic positioning member 40, which causes a relative displacement between the elastic positioning member 40 and the self-expanding stent 10, generating a large tensile acting force and increasing the risk of the elastic positioning member 40 breaking; when the first connection point L1 and the second connection point L2 all overlap with the vertices of the outflow end mesh 12, the risk of breaking increases significantly. Therefore, in the present application, the more the first connection point L1, the second connection point L2 and the vertices of the outflow end mesh are dispersed, the smaller the acting force pulling the elastic positioning member 40 can be, and the more effectively the risk of breaking both ends of the elastic positioning member 40 can be reduced; preferably, at least one of the first connection point L1 and the second connection point L2 is provided offset from the vertices of the outflow end mesh 12.

[0055] Apparently, there are three cases where the above-mentioned offsetting is performed. First, as shown in Fig. 4, the second connection point L2 overlaps with a vertex of the outflow end mesh 12, and the first connection point L1 is offset from the above-mentioned overlapping point, in which case the connection arm 42 may be directly connected to the support arm 52. Second, as shown in Fig. 5, the first connection point L1 overlaps with a vertex of the outflow end mesh 12, and the second connection point L2 is offset from the above-mentioned overlapping point. Third, both the first connection point L1 and the second connection point L2 are offset from the vertex of the outflow end mesh 12.

[0056] Regardless of the above connection method, effectively isolating one of the first connection points or the second connection points serves to distribute forces and helps to prevent the elastic positioning member 40 from breaking.

[0057] In a preferred embodiment of the present application, the number of elastic connecting members 40 and outflow end release members 50 is three, and the three elastic positioning members and outflow end release members 50 are all uniformly distributed along the circumferential direction of the self-expanding stent 10.

[0058] The relative included angle between the connecting arm 42 and the outflow end mesh 12 can meet the usage requirements within a certain included angle range. Specifically, the included angle range between the connecting arm 42 and the tangent plane of the corresponding outflow end mesh 12 is 0 to 45°. As shown in Figure 6, this is a plan view in which the included angle between the connecting arm 42 and the tangent plane of the self-expanding stent 10 is 45 degrees.

[0059] Analysis of the fracture situation of the elastic positioning member 40 reveals that the main fracture force comes from radial pressure, therefore, it is optimal for the connecting arm 42 to be in contact with the self-expanding stent 10. When the cardiac tissue exerts radial pressure on the elastic positioning member 40, this structure will distribute the radial pressure to the self-expanding stent 10, and the self-expanding stent will bear the force, thereby achieving the effect that the elastic positioning member 40 can offset the radial pressure. In this embodiment, as shown in FIG. 7, the connecting arm 42 is located on a plane that is in contact with the corresponding self-expanding stent 10, that is, the included angle between the connecting arm 42 and the tangent plane of the corresponding outflow end mesh 12 is 0.

[0060] Referring to the above description, the present application can effectively reduce the risk of the elastic positioning member being torn by distributing the force while offsetting the force, and greatly extend the service life of the heart valve.

[0061] However, in the actual use of the heart valve, with the passage of time and aging of the material, breakage and detachment may still occur between the elastic positioning member 40 and the self-expanding stent 50, and if the elastic positioning member 40 moves freely in the body, it may pierce the heart and cause irreversible serious damage to the patient's body, so it is necessary to provide an effective repair means. As shown in Figures 8 and 9, in another preferred embodiment of the present application, repair parts 43 are formed at positions adjacent to both ends of the U-shaped part 41, and the transcatheter aortic valve replacement device further includes a repair member (not shown), and the repair part 43 may be connected to the self-expanding stent 10 through the repair member. In some embodiments, the repair part 43 is a thick part with a hole formed at the end of the U-shaped part 41. In another embodiment, the repair part is a hook part formed at the end of the U-shaped part 41, which may be a closed ring or a hook bent inward.

[0062] The repair portion 42 and the first connection point L1 are located at both ends of the connecting arm 42, and in some embodiments, the repair member is a soft sheet-like structure, and the repair member can wrap or wrap around the connecting arm 42 along the length of the connecting arm 42, and both ends of the repair member corresponding to the connecting arm are fixed to the corresponding first connection point L1 and the repair portion 43.

[0063] Preferably, in the above embodiment, the repair material is a polyester fabric or bovine pericardium.

[0064] In some other embodiments, the repair member may be a thin elongated structure, specifically a rope or nickel titanium wire, and the number is one, and one end of the repair member may be connected to the self-expanding stent 10 by passing through all the repair sections 43 in sequence. In some other embodiments, the number of repair members is equal to the number of elastic positioning members 40, and one end of each repair member is connected to the self-expanding stent 10 by passing through the repair sections 43 in the same U-shaped section 41 in sequence, and the connection can be selected to be hooked, wrapped or tied on the self-expanding stent 10, as long as it can ensure that the U-shaped section 41 does not come off the self-expanding stent 10.

[0065] After using the above technical means, if the elastic positioning member 40 falls off or the connection is unstable, the connection relationship between the elastic positioning member 40 and the self-expanding stent 10 can be promptly restored by the repair member, thereby preventing damage to the patient's body.

[0066] In a preferred embodiment of the present application, the transcatheter aortic valve replacement device further includes a protective member 44, which is connected to the outside of the central part of the U-shaped portion 41 by suturing, wrapping or wrapping. The protective member 44 is preferably a polyester cloth or bovine pericardium.

[0067] In the embodiment of the present application, the hole diameter of the through hole gradually decreases along the first direction A, and then remains unchanged or gradually increases, and such a trumpet-shaped opening can well fix the self-expanding stent 10 at the position of the aortic valve of the human body, and the release mesh 53 is curved inwardly of the through hole along the first direction A. As a preferred connection manner, the release portion 52 is an annular structure, and the delivery system and the release portion 52 are connected using a strip-shaped connection member with a coil, and the coil can penetrate the other side of the release portion 52 along the second direction, and the axially retractable strip-shaped member penetrates the coil to realize the position restriction of the release portion 52, and when the strip-shaped member is pulled out from the coil, the release portion 52 can be released from the outside of the coil under elastic action to complete the release of the outflow end. Since the release mesh 53 is curved inwardly along the first direction A, the entire strip-shaped member is located inside the tubular interior formed after the self-expanding stent is compressed, and the strip-shaped member will not damage the heart tissue.

[0068] To ensure the stability of the structural connection between the self-expanding stent 10 and the elastic positioning member 40, the elastic positioning member 40 and the self-expanding stent 10 are cut together from a nickel-titanium alloy tube and then heat-fixed.

[0069] In order to realize accurate release installation of the inflow end, as shown in Figures 1 and 2, the transcatheter aortic valve replacement device further includes a number of inflow end release members 60, each of which includes an elliptical structure 61 connected to the apex of the inflow end mesh 11. The elliptical structure 61 has no sharp edges and its outer surface is a smooth curved surface, so that the movement space of the inflow end release member 60 is small and the inflow end release member 60 is prevented from being damaged. In order to further improve the softness of the elliptical structure, the center part has a through hole formed along the radial direction of the through hole, so that the entire elliptical structure 61 is annular, and a solid elliptical structure is hard and protrudes outward from the inflow end, which is easy to damage the heart tissue, while the annular structure and the material of nickel titanium alloy are softer and less likely to damage the organ tissue of the human body. At the same time, both sides of the annular inflow end release member 60 and the outflow end release member 50 are fixed to the delivery system, which does not affect the installation and release function of the stent.

[0070] In a preferred embodiment, the extension line of the short axis of the elliptical structure 61 is parallel to the axis of the through hole, and the extension line of the long axis of the elliptical structure 61 is located on the tangent plane of the corresponding inflow end mesh 11. Thus, the inflow end mesh 11 has a vertical squeeze design at the apex, which can effectively prevent damage to the aortic vascular wall during the installation process of the transcatheter aortic valve replacement device.

[0071] The above are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention should be included within the protection scope of the present invention.

Claims

1. a self-expanding stent, a skirt, leaflets, at least two resilient positioning members, an outflow end release member, and an inflow end release member; A through hole is defined inside the self-expanding stent through which a liquid flows, the self-expanding stent has an inflow end corresponding to the through hole and an outflow end opposite the inflow end, the side wall of the self-expanding stent has a mesh structure, the skirt portion is connected to the side wall of the through hole, the valve leaflets are connected to the inside of the skirt portion, and the side wall adjacent to the outflow end of the self-expanding stent is defined by a plurality of outflow end meshes arranged in a ring shape, The elastic positioning member has a U-shaped portion and connecting arms located at both ends of the U-shaped portion, the connecting arms are connected to the outflow end, the U-shaped portion is located outside the self-expanding stent, and the central portion of the U-shaped portion extends toward the inflow end and can be elastically folded back; 1. A transcatheter aortic valve replacement device with a bilateral locking function, comprising: an outflow end release member connected to the outflow end of the self-expanding stent and located between the two elastic positioning members; and an inflow end release member connected to the inflow end of the self-expanding stent.

2. The transcatheter aortic valve replacement device with bilateral locking function according to claim 1, characterized in that the connection arm is connected to the outflow end mesh or the outflow end release member to form a first connection point, the outflow end release member is connected to the outflow end mesh to form a second connection point, and at least one of the first connection point and the second connection point is offset from a vertex of the outflow end mesh.

3. The transcatheter aortic valve replacement device with bilateral locking function according to claim 1, characterized in that the range of the included angle between the connecting arm and the corresponding tangent plane of the outflow end mesh is 0 to 45 degrees.

4. The transcatheter aortic valve replacement device with bilateral locking function of claim 3, wherein the connecting arms lie in a plane tangent to the corresponding outflow end mesh.

5. 2. The transcatheter aortic valve replacement device with bilateral locking function according to claim 1, wherein the number of the elastic positioning members is three, and the three elastic positioning members are uniformly distributed along the circumferential direction of the self-expanding stent.

6. 6. The transcatheter aortic valve replacement device with bilateral locking function according to claim 1, wherein a repair portion is formed in a position adjacent to both ends of the U-shaped portion, the transcatheter aortic valve replacement device further includes a repair member, and the repair portion is connected to the self-expanding stent via the repair member.

7. 7. The transcatheter aortic valve replacement device with bilateral locking function of claim 6, characterized in that the repair part and the first connection point are located at both ends of the connection arm, the repair member has a soft sheet-like structure, the repair member can encase or wrap the connection arm along a longitudinal direction of the connection arm, and both ends of the repair member corresponding to the connection arm are fixed to the corresponding first connection point and the repair part.

8. 7. The transcatheter aortic valve replacement device with bilateral locking function according to claim 6, characterized in that the repair member is a thin, elongated structure, there is only one of the repair members, and one end of the repair member passes through all of the repair portions in sequence and is connected to the self-expanding stent.

9. 7. The transcatheter aortic valve replacement device with bilateral locking function according to claim 6, wherein the repair members are thin, elongated structures, and the number of the repair members is equal to the number of the elastic positioning members, and one end of each of the repair members is connected to the self-expanding stent by passing through the repair members in the same U-shaped portion in sequence.

10. 8. The transcatheter aortic valve replacement device with bilateral locking function of claim 7, further comprising a protective member, the protective member being connected to the outside of the central portion of the U-shaped portion by suturing, wrapping or winding.

11. The transcatheter aortic valve replacement device with bilateral locking function according to claim 10, characterized in that the repair member and the protective member are polyester cloth or bovine pericardium.

12. 2. The transcatheter aortic valve replacement device with bilateral locking function according to claim 1, characterized in that the outflow end release member includes a release portion and support arms located on both sides of the release portion, the second connection point connects the support arm and the self-expanding stent, the two second connection points of the same outflow end release member are located on the tops of different outflow end meshes, and the release portion extends in a direction away from the inflow end.

13. 13. The transcatheter aortic valve replacement device with bilateral locking function according to claim 12, characterized in that a release mesh is defined between the support arm of each of the outflow end release members and the outside of two adjacent outflow end meshes, one end adjacent to the inflow end of the valve leaflet and the skirt portion are sewn together along a circumferential direction, and a connection point between the other end and the skirt portion is located inside the release mesh.

14. The transcatheter aortic valve replacement device with bilateral locking function of claim 13, characterized in that the hole diameter of the through hole gradually decreases along a first direction and then remains unchanged or gradually increases, and the release mesh curves inwardly of the through hole along the first direction.

15. The transcatheter aortic valve replacement device with bilateral locking function as described in claim 13, characterized in that the elastic positioning member and the self-expanding stent are cut integrally from a nickel-titanium alloy tube and then heat-fixed.

16. 2. The transcatheter aortic valve replacement device with bilateral locking function of claim 1, wherein a sidewall adjacent to the inflow end of the self-expanding stent is defined by a plurality of inflow end meshes arranged in an annular shape, and the inflow end release member includes an elliptical structure connected to vertices of the inflow end meshes.

17. The transcatheter aortic valve replacement device with bilateral locking function according to claim 16, characterized in that the central portion of the elliptical structure has a through hole formed along the radial direction of the through hole.

18. The transcatheter aortic valve replacement device with bilateral locking function according to claim 16, characterized in that the extension line of the short axis of the elliptical structure is parallel to the axis of the through hole, and the extension line of the long axis of the elliptical structure is located on a tangent plane of the corresponding inflow end mesh.

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