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 the structural design of devices for artificial heart valve intervention therapy, and specifically relates to a transcatheter aortic valve replacement device having a bilateral locking function.

Background Art

[0002] With the aging of humans, the incidence rate of valvular heart disease has clearly increased. Currently, conventional surgical treatment is still the top-priority treatment method for many patients with severe valvular lesions, but there are risks such as large trauma, high postoperative mortality, and high complications. In recent years, transcatheter valve implantation / repair has gradually matured and been widely applied. In particular, transcatheter aortic valve implantation (TAVR / TAVI) has sufficient medical evidence based on evidence, significantly reduced trauma, and has obtained recommendations from the heart valve disease treatment guidelines in Europe and the United States, which is a major advancement in the field of heart valve disease intervention therapy.

[0003] Transcatheter aortic valve implantation (TAVI) is a new technique that uses an interventional method to implant an artificial aortic valve. First reported in 2002 by Dr. Criber in France, it brought hope to the treatment of patients with severe aortic stenosis (AS) who had lost the opportunity for surgical intervention (e.g., those over 80 years old), adding a new chapter to the history of interventional cardiovascular disease treatment. Over the following decade, with improvements in equipment and accumulated experience, TAVI technology became perfected, and it is now performed continuously at 500 heart centers in approximately 40 countries, with a total of over 150,000 surgeries performed. In particular, after a series of registry studies and randomized controlled studies that successively confirmed its effectiveness, feasibility, and safety, TAVI technology has become the top priority treatment method for patients with severe AS who cannot undergo surgical valve replacement. Clinically, the artificial bioprosthetic valves used in TAVI are mainly of two types: Edwards Sapien (Edwards Corporation, USA), which is implanted by balloon inflation, and CoreValve (Medtronic Corporation, USA), which is implanted by self-inflation. TAVI technology has already made internationally recognized advancements and is already being applied in a preliminary stage in China, demonstrating similar broad future potential. Currently, the Chinese market for heart valve devices is highly dominated by foreign brands, with foreign companies such as Edwards Lifesciences, Medtronic, LivaNova (already acquired by Solin), St. Jude Medical (already acquired by Abbott), and On-X holding approximately 85% of the market share. Edwards Lifesciences and Medtronic have the entire product line, from mechanical valves and bioprosthetic valves to transcatheter interventional valves. However, domestic manufacturers of devices are emerging in China, and currently, three domestically produced transcatheter aortic valves have received approval from the Chinese CFDA and are on the market: Venus-A from Qiming Medical, J-valve from Suzhou Jiecheng, and VitaFlow from Microinventory. Nevertheless, no Chinese company yet holds an absolute advantage.

[0004] Statistical analysis of hospital patient ultrasound electrocardiogram databases shows that in patients aged 65-74 years (49,995 cases) and ≥75 years (34,671 cases), the detection rates for moderate or severe aortic regurgitation (AR) were 2.12% and 2.85%, respectively, and the detection rates for moderate or severe aortic stenosis (AS) were 0.75% and 0.89%, respectively. The detection rates for severe aortic regurgitation (SAR) and severe aortic stenosis (SAS) in the two groups of patients were 0.52% vs. 0.95% and 0.54% vs. 0.57%, respectively. This indicates that elderly people in China tend to develop aortic regurgitation in cases of aortic valve degenerative disease. There are some differences between patients with aortic valve disease in China and patients in Western countries. (1) The proportion of bicuspid aortic valves in Chinese patients is high, with 40% to 50% of patients having bicuspid aortic valves, which is significantly higher than the 1.6% to 9.3% in patients in Western countries. Many large-scale TAVR clinical studies in Western countries use bicuspid aortic valves as an exclusion criterion. (2) The aortic valves in Chinese patients have a high degree of calcification. (3) Aortic regurgitation is more common than aortic stenosis in Chinese patients. (4) The femoral artery diameter is narrow, with an average femoral artery diameter of 6.5 mm in Chinese TAVR candidate cases.

[0005] Qiming Medical's Venus-A and Weichuang Xintong's VitaFlow utilize a percutaneous, self-expanding stent design, primarily addressing aortic stenosis. Suzhou Jiechong's J-valve also utilizes a self-expanding stent design and has three anchor devices to fix the stent to the base of the valve leaflet, addressing aortic regurgitation. However, it utilizes a transapical route, resulting in larger wounds than the percutaneous route. Furthermore, the valves in Qiming Medical's Venus-A and Suzhou Jiechong's J-valve products use porcine pericardium, while Weichuang Xintong's VitaFlow uses bovine pericardium, with bovine pericardium having superior durability compared to porcine pericardium. In summary, all three aortic valve products currently marketed in China have limitations in treating certain diseases or suffer from performance deficiencies.

[0006] In a Chinese invention patent application with application number 2021107458307, a transcatheter aortic valve device for automatically capturing valve leaflets is provided. This device comprises a stent, a skirt portion, and a positioning member. The positioning member is an extension of the stent, and the connection point between the positioning member and the stent is also a stent release structure. In actual use, it is necessary to release the stent using the connection point between the stent and the positioning member. When the above technology is used in the clinical surgical process, if the connection point between the stent and the positioning member is used for stent release, it affects the positioning of the positioning member, resulting in inaccurate positioning of the device, poor postoperative results, and in serious cases, even threaten the patient's life. Furthermore, it has been discovered that when blood and cardiac tissue exert a large force on the stent, relative displacement occurs between the stent and the positioning member, causing the positioning member to be pulled and affecting its service life. [Overview of the project] [Problems that the invention aims to solve]

[0007] Based on the above circumstances, the present invention provides a transcatheter aortic valve replacement device having a bilateral locking function in order 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 further 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 with bilateral locking function includes a self-expanding stent, a skirt portion, valve leaflets, at least two elastic positioning members, an outflow end release member, and an inflow end release member. The self-expanding stent has a through-hole through which liquid flows, and the self-expanding stent has an inlet end and an outlet end opposite to the inlet end, the side wall of the self-expanding stent is a mesh structure, the skirt portion is connected to the side wall of the through-hole, the valve leaflet is connected to the inside of the skirt portion, and the side wall of the self-expanding stent adjacent to the outlet end is defined by a plurality of outlet end meshes arranged in an annular pattern. The elastic positioning member has a U-shaped portion and connecting arms located at both ends of the U-shaped portion, the connecting arms being connected to the outflow end, the U-shaped portion being located outside the self-expanding stent, the central portion of the U-shaped portion extending toward the inflow end and being elastically foldable. The outlet end release member is connected to the outlet end of the self-expanding stent and is located between the two elastic positioning members, and the inlet end release member is connected to the inlet end of the self-expanding stent.

[0010] Compared to the prior art, the technical means of this invention has the following beneficial technical effects.

[0011] In the transcatheter aortic valve replacement device according to the present invention, the stent is provided with an elastic positioning member and an outflow end release member, respectively. The two functions of stent positioning and outflow end release are separated and made independent of each other, preventing them from influencing one another. This effectively prevents the positioning member from being affected when the stent is released by the outflow end release member, and thus prevents the effective placement of the entire self-expanding stent. Furthermore, by mounting the outflow end release member between the elastic positioning members, the compactness and stability of the overall device structure are effectively ensured, and the outflow end release member, inflow end release member, and delivery system can form a double-sided fixed structure, making it easier to install inside the delivery system.

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

[0013] Furthermore, the connecting 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 and second connection points is provided offset from the vertex of the outflow end mesh.

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

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

[0016] Furthermore, the connecting arm is positioned in a plane that is in contact with the corresponding outflow end mesh.

[0017] Using the above technical means, the radial pressure acting on the elastic positioning member is effectively distributed to the self-expanding stent, and the self-expanding stent, by receiving this force, cancels out the radial force acting on the positioning member.

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

[0019] Furthermore, repair sections are formed near both ends of the U-shaped section, and the transcatheter aortic valve replacement device further includes a repair member, the repair section being 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 has a soft sheet-like structure. The repair member can wrap or wind around the connection arm along the length direction of the connection arm. Both ends of the repair member corresponding to the connection arm are fixed to the corresponding first connection point and the repair part.

[0021] By using the above technical means, by winding the repair member around the connection arm and fixing the repair member, the connection between the connection arm and the self-expanding stent and the U-shaped part is further strengthened. When any one 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 has a thin and long structure and the number thereof is one. One end of the repair member passes through all the repair parts in sequence and is connected to the self-expanding stent.

[0023] Furthermore, the repair member has a thin and long structure and the number thereof is equal to the number of the elastic positioning members. One end of each repair member passes through the repair parts in the same U-shaped part 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 repair member can timely repair the connection relationship between the elastic positioning member and the self-expanding stent, thereby preventing further damage to the patient's body.

[0025] Furthermore, the transcatheter aortic valve replacement device further includes a protection member. The protection member is connected to the outside of the central part of the U-shaped part by suturing, wrapping or winding.

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

[0027] By using the above technical means, during use, the U-shaped part effectively prevents the heart tissue or blood vessel wall from being damaged by the wrapping of the protection member.

[0028] Furthermore, the outflow end release member includes a release part and support arms located on both sides of the release part. The second connection point is formed by connecting the support arm and the self-expanding stent. The two second connection points of the same outflow end release member are located at the tops of different outflow end meshes, and the release part extends in a direction away from the outflow end along the first direction.

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

[0030] Furthermore, a release mesh is defined between the support arm of each outflow end release member and the outside of two adjacent outflow end meshes. One end of the valve tip close to the inflow end and the skirt portion are stitched along the circumferential direction, and the connection location between the other end and the skirt portion is located inside the release mesh.

[0031] By using the above technical means, a release mesh is defined between the support arm and the outside of two adjacent outflow end meshes, and the connection location between one end of the valve tip close to the outflow end and the skirt portion is provided inside the release mesh. As a result, the size of the release mesh becomes much larger than the available position of the connection location in the prior art, making the adhesion between the valve tip and the skirt portion more convenient and firm, and extending the service life of the device.

[0032] Furthermore, the aperture diameter of the through hole gradually decreases and then does not change or gradually increases along the first direction, and the release mesh curves inside the through hole along the first direction.

[0033] Furthermore, the elastic positioning member and the self-expanding stent are formed by thermally fixing after integrally cutting a nickel-titanium alloy pipe.

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

[0035] Furthermore, the side wall of the self-expanding stent adjacent to the inlet end is defined by a plurality of inlet end meshes arranged in an annular manner, and the inlet end release member includes an elliptical structure connected to the vertices of the inlet end meshes.

[0036] By using the above technical means, the elliptical structure has no sharp ends and its outer surface is a smooth curved surface, thereby reducing the movement space of the inlet end release member and preventing damage to the blood vessel wall.

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

[0038] Using the above technical means, the entire elliptical structure is ring-shaped, and compared to a solid elliptical structure, the entire structure is softer and less likely to damage human organs and tissues.

[0039] Furthermore, the extension of the minor axis of the elliptical structure is parallel to the axis of the through hole, and the extension of the major axis of the elliptical structure lies on the tangent plane of the corresponding inlet end mesh.

[0040] Using the above technical means, the inlet end mesh has a vertical taut design at its apex, which effectively prevents damage to the aortic vessel wall during stent placement. [Brief explanation of the drawing]

[0041] [Figure 1] This is a perspective view of a transcatheter aortic valve replacement device having a bilateral locking function according to an embodiment of the present invention. [Figure 2] This is a schematic diagram of the structure with the skirt and valve leaflets hidden in Figure 1. [Figure 3] This is a schematic diagram of the overlapping connection structure of the first connection point, the second connection point, and the outflow end mesh vertices. [Figure 4]This is a schematic diagram of the structure of the first type of offset embodiment of the present invention. [Figure 5] This is a schematic diagram of the structure of the second type of offset embodiment of the present invention. [Figure 6] This is a plan view showing the support arm and the self-expanding stent forming a constant angle. [Figure 7] This is a plan view showing the support arm in contact with the self-expanding stent. [Figure 8] Figure 5 is a schematic diagram of the structure of another embodiment having a repaired section. [Figure 9] This is a schematic diagram of the structure of the repair section in another embodiment of the present invention. [Figure 10] This is a schematic diagram of a compression structure according to an embodiment of the present invention. [Modes for carrying out the invention]

[0042] To facilitate understanding of this application, the application will be described more comprehensively below with reference to the relevant drawings. While the drawings illustrate embodiments of the application, it can be realized in many different forms and is not limited to the embodiments described herein. Conversely, the purpose of providing these embodiments is to provide a more complete and comprehensive understanding of the disclosure.

[0043] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application pertains. The terms used herein in this description are for the sole purpose of illustrating specific examples and are not intended to limit this application.

[0044] As shown in Figure 1, the present invention provides a transcatheter aortic valve replacement device having a bilateral locking function, comprising a self-expanding stent 10, a skirt portion 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, and the self-expanding stent 10 has an inlet end 1a and an outlet end 1b opposite to the inlet end 1a corresponding to the through-hole, the side wall of the self-expanding stent 10 is a mesh structure, the skirt portion 20 is connected to the side wall of the through-hole, and the valve leaflet 30 is connected to the inside of the skirt portion 20, and as shown in Figure 2, the valve leaflet 30 is configured to allow blood to pass through the through-hole along a first direction A, from the inlet end 1a to the outlet 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 of the self-expanding stent 10 adjacent to the inlet end 1a is defined by a plurality of inlet end meshes 11 arranged in an annular manner, and the side wall of the self-expanding stent 10 adjacent to the outlet end 1b is defined by a plurality of outlet end meshes 12 arranged in an annular manner.

[0046] As shown in Figure 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 on the outside of the self-expanding stent 10, and the central part of the U-shaped portion 41 extends toward the inlet 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 Figure 10, the U-shaped portion 41 can be elastically folded back and extend toward the outlet end.

[0047] The outlet end release member 50 is connected to the outlet 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 outlet end mesh 12 or the outlet end release member 50 to form a first connection point L1, and the outlet end release member 50 is connected to the outlet end mesh 12 to form a second connection point L2.

[0048] This embodiment separates the two functions of elastic positioning of the self-expanding stent 10 and release of the outflow end mesh 12, making them independent of each other and preventing them from influencing one another. This effectively avoids the situation where the self-expanding stent 10 interferes with the positioning and mounting of the elastic positioning member 40 during the outflow end release process, preventing the heart valve from being accurately positioned. Furthermore, by mounting the outflow end release member 50 between the elastic positioning members 40, the compactness and stability of the overall structure of the device are effectively ensured.

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

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

[0051] The release section 51 is connected to a delivery system that delivers the valve device into the human body. When the connection between the release section 51 and the delivery system is disconnected, the outlet end release member 50 expands outward by the self-expanding stent 10, opening the outlet end 1b. After installation is complete, the outlet end release member 50 and the elastic positioning member 40 extend in two directions, further reducing their mutual influence.

[0052] More preferably, a release mesh 53 is defined between the support arm 52 of each outflow end release member 50 and the outside of two adjacent outflow end meshes 12, one end of the valve leaflet 30 adjacent to the inflow end 1a 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 outside of two adjacent outflow end meshes 12, and providing the connection point between the one end of the valve leaflet 30 adjacent to the outflow end mesh 12 and the skirt portion 20 inside the release mesh 53, the size of the release mesh 53 becomes much larger than the usable positions of the connection point in the prior art, making the adhesion between the valve leaflet 30 and the skirt portion 20 more convenient and robust, and extending the service life of the heart valve device.

[0053] Regarding the connection method between the elastic positioning member 40 and the outlet end release member 50, the most obvious and easily conceivable method is, as shown in Figures 2 and 3, that both the first connection point L1 and the second connection point L2 are connected to the vertices of the outlet end mesh 12.

[0054] Analysis of the stress conditions during the use of the transcatheter aortic valve replacement device revealed that, during use, the outer walls of both the self-expanding stent 10 and the elastic positioning member 40 come into contact with cardiac tissue. First, the elastic positioning member 40 must receive pressure from the cardiac tissue along the radial direction of the self-expanding stent 10. Simultaneously, frictional force is generated when blood flows through the passage, and because the blood pressure is uneven, a vortex rotational force is generated. This causes a relative rotational tendency between the self-expanding stent 10 and the elastic positioning member 40, resulting in a rotational tensile force. Furthermore, since the connection point between one end of the valve leaflet 30, which is close to the outflow end mesh 12, and the skirt portion 20 is located inside the open mesh 53, when blood flows through the passage, the valve leaflet 30 opens and closes periodically, causing the area near the outflow end mesh 12 to oscillate periodically, resulting in 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, all of the above-mentioned forces act on the elastic positioning member 40, causing a relative displacement between the elastic positioning member 40 and the self-expanding stent 10, generating a large tensile force and increasing the risk of the elastic positioning member 40 breaking. If both the first connection point L1 and the second connection point L2 overlap with the vertices of the outflow end mesh 12, the risk of this breaking increases significantly. For this reason, in this 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 tensile force acting on the elastic positioning member 40 can be, effectively reducing the risk of both ends of the elastic positioning member 40 breaking. Preferably, at least one of the first connection point L1 and the second connection point L2 is offset from the vertices of the outflow end mesh 12.

[0055] Clearly, there are three cases in which the above offset configuration can be implemented. First, as shown in Figure 4, the second connection point L2 coincides with a vertex of the outflow end mesh 12, and the first connection point L1 is offset from the overlapping point, in which case the connecting arm 42 may be directly connected to the support arm 52. Second, as shown in Figure 5, the first connection point L1 coincides with a vertex of the outflow end mesh 12, and the second connection point L2 is offset from the overlapping point. Third, both the first connection point L1 and the second connection point L2 are offset from the vertices of the outflow end mesh 12.

[0056] Regardless of the connection method described above, effectively separating either the first or second connection point helps to distribute the force, thereby preventing the elastic positioning member 40 from breaking.

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

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

[0059] Analysis of the fracture mechanism of the elastic positioning member 40 revealed that the main fracture force originates from radial pressure. Therefore, it is optimal for the connecting arm 42 to be in contact with the self-expanding stent 10. When cardiac tissue applies radial pressure to the elastic positioning member 40, the structure distributes the radial pressure to the self-expanding stent 10, and the self-expanding stent receives this force, thereby achieving the effect of the elastic positioning member 40 canceling out the radial pressure. In this embodiment, as shown in Figure 7, the connecting arm 42 is positioned in a plane in contact with the corresponding self-expanding stent 10, that is, the angle between the connecting arm 42 and the tangent plane of the corresponding outflow end mesh 12 is 0.

[0060] As described above, this invention effectively reduces the risk of the elastic positioning member being torn by distributing and canceling out forces, thereby significantly extending the service life of the heart valve.

[0061] However, in actual use of the heart valve, as time passes and the material ages, fracture and detachment between the elastic positioning member 40 and the self-expanding stent 50 may still occur. If the elastic positioning member 40 moves freely within the body, it may puncture the heart and cause irreversible and serious injury to the patient's body, thus requiring an effective repair method. As shown in Figures 8 and 9, in another preferred embodiment of the present application, repair portions 43 are formed near both ends of the U-shaped portion 41, and the transcatheter aortic valve replacement device further includes a repair member (not shown), the repair portions 43 may be connected to the self-expanding stent 10 via the repair member. In some embodiments, the repair portions 43 are thickened portions with holes formed at the ends of the U-shaped portion 41. In another embodiment, the repair portions are hooks formed at the ends of the U-shaped portion 41, which may be closed annular or inwardly folded hooks.

[0062] The repair portion 42 and the first connection point L1 are located at both ends of the connecting arm 42. In some embodiments, the repair member is a soft sheet-like structure and can wrap around or enclose the connecting arm 42 along its length. The 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 member is polyester cloth or bovine pericardium.

[0064] In some other embodiments, the repair member may be a thin, elongated structure, specifically a rope or a nickel-titanium wire, and there may be only one such repair member, with one end passing through all the repair sections 43 in sequence and connected to the self-expanding stent 10. In some other embodiments, the number of repair members is equal to the number of elastic positioning members 40, with one end of each repair member passing through the repair sections 43 in the same U-shaped section 41 in sequence and connected to the self-expanding stent 10, and the connection may be made by hooking, wrapping, or tying the U-shaped section 41 to the self-expanding stent 10, as long as it is ensured that the U-shaped section 41 does not detach from the self-expanding stent 10.

[0065] If the elastic positioning member 40 falls off or the connection becomes unstable after using the above technical means, the repair member can promptly repair the connection between the elastic positioning member 40 and the self-expanding stent 10, thereby preventing injury 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, the protective member 44 being connected to the outside of the central portion of the U-shaped portion 41 by suturing, wrapping, or winding. The protective member 44 is preferably made of polyester cloth or bovine pericardium.

[0067] In the embodiment of the present invention, the 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 allows the self-expanding stent 10 to be well fixed in the position of the aortic valve in the human body, and the release mesh 53 curves inward along the first direction A. As a preferred connection method, the release section 52 is annular in structure, and the delivery system and the release section 52 are connected using a strip-shaped connecting member with a coil, the coil may penetrate the other side of the release section 52 along the second direction, the axially pullable strip-shaped member penetrates the coil to achieve positional restriction of the release section 52, and when the strip-shaped member is pulled out from the coil, the release section 52 can detach from the outside of the coil under elastic action to complete the release of the outflow end. Because the release mesh 53 curves inward along the first direction A, the entire strip-shaped member is located inside the tubular structure formed after the self-expanding stent is compressed, and the strip-shaped member does not damage cardiac tissue.

[0068] To ensure the structural stability of the 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 formed by heat-fixing a nickel-titanium alloy tube after it has been cut as a single piece.

[0069] To ensure accurate release and insertion of the inlet end, as shown in Figures 1 and 2, the transcatheter aortic valve replacement device further includes a plurality of inlet end release members 60, each including an elliptical structure 61 connected to the vertices of the inlet end mesh 11. The elliptical structure 61 has no sharp ends and its outer surface is a smooth curved surface, thus reducing the movement space of the inlet end release member 60 and preventing damage to the blood vessel wall. To further improve the flexibility of the elliptical structure, its central portion has a through-hole formed along the radial direction of the through-hole. Thus, the entire elliptical structure 61 is annular. A solid elliptical structure is rigid, protrudes outward from the inlet end, and is prone to damaging cardiac tissue. Having an annular structure and using a nickel-titanium alloy material makes it softer and less likely to damage human organ tissue. At the same time, both the annular inlet end release member 60 and the outlet end release member 50 are fixed to the delivery system on both sides and do not affect the stent insertion and release functions.

[0070] In a preferred embodiment, the extension of the minor axis of the elliptical structure 61 is parallel to the axis of the through hole, and the extension of the major axis of the elliptical structure 61 is located on the tangent plane of the corresponding inlet end mesh 11. Thus, the inlet end mesh 11 has a vertical taut design at its apex, which effectively prevents damage to the aortic vessel wall during the insertion process of the transcatheter aortic valve replacement device.

[0071] The foregoing are merely preferred embodiments of the present invention and are not intended to limit the invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the invention should be included within the scope of protection of the present invention.

Claims

1. The self-expanding stent includes a skirt portion, valve leaflets, at least two elastic positioning members, an outlet end release member, and an inlet end release member. The self-expanding stent has a through-hole through which liquid flows, and the self-expanding stent has an inlet end and an outlet end opposite to the inlet end, the side wall of the self-expanding stent is a mesh structure, the skirt portion is connected to the side wall of the through-hole, the valve leaflet is connected to the inside of the skirt portion, and the side wall of the self-expanding stent adjacent to the outlet end is defined by a plurality of outlet end meshes arranged in an annular pattern. The elastic positioning member has a U-shaped portion and connecting arms located at both ends of the U-shaped portion, the connecting arms being connected to the outflow end, the U-shaped portion being located outside the self-expanding stent, the central portion of the U-shaped portion extending toward the inflow end and being elastically foldable, the connecting arms being in contact with the self-expanding stent, there being three elastic positioning members, the three elastic positioning members being uniformly distributed along the circumferential direction of the self-expanding stent, A transcatheter aortic valve replacement device having a double-sided locking function, characterized in that the outflow end release member is connected to the outflow end of the self-expanding stent and is located between two adjacent elastic positioning members, and the inflow end release member is connected to the inflow end of the self-expanding stent.

2. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 1, characterized in that the connecting 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 provided offset from the vertex of the outflow end mesh.

3. The transcatheter aortic valve replacement device having a bilateral locking function according to claim 2, characterized in that repair portions are formed at positions close to both ends of the U-shaped portion, the transcatheter aortic valve replacement device further includes a repair member, and the repair portions are connected to the self-expanding stent via the repair member.

4. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 3, wherein the repair portion and the first connection point are located at both ends of the connecting arm, the repair member has a soft sheet-like structure, the repair member can wrap around or wrap around the connecting arm along the longitudinal direction of the connecting arm, and the ends of the repair member corresponding to the connecting arm are fixed to the corresponding first connection point and the repair portion.

5. The transcatheter aortic valve replacement device having a bilateral locking function according to claim 3, characterized in that the repair member has a slender, elongated structure and there is only one of them, and one end of the repair member penetrates all of the repair portions in sequence and is connected to the self-expanding stent.

6. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 3, characterized in that the repair members have a slender, elongated structure, and their number is equal to the number of elastic positioning members, and one end of each repair member sequentially passes through the repair portion in the same U-shaped section and is connected to the self-expanding stent.

7. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 4, further comprising a protective member, wherein the protective member is connected to the outside of the central part of the U-shaped portion by suturing, wrapping, or winding.

8. The transcatheter aortic valve replacement device having a bilateral locking function according to claim 7, characterized in that the repair member and the protective member are made of polyester cloth or bovine pericardium.

9. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 2, characterized in that the outflow end release member includes an opening portion and support arms located on both sides of the opening 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 at the tops of different outflow end meshes, and the opening portion extends in a direction away from the inflow end.

10. Transcatheter aortic valve replacement device having a double-sided locking function according to claim 9, characterized in that a release mesh is defined between the support arm of each outlet end release member and the outside of two adjacent outlet end meshes, one end of the valve leaflet adjacent to the inlet end and the skirt portion are sutured together along the circumferential direction, and the connection point between the other end and the skirt portion is located inside the release mesh.

11. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 10, characterized in that the diameter of the through-hole gradually decreases along the first direction and then remains unchanged or gradually increases, and the release mesh curves inward along the first direction towards the through-hole.

12. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 10, characterized in that the elastic positioning member and the self-expanding stent are formed by integrally cutting a nickel-titanium alloy tube and then heat-fixing it.

13. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 1, characterized in that the side wall of the self-expanding stent adjacent to the inlet end is defined by a plurality of inlet end meshes arranged in an annular manner, and the inlet end release member includes an elliptical structure connected to the vertices of the inlet end meshes.

14. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 13, characterized in that the central part of the elliptical structure has a through hole formed along the radial direction of the through hole.

15. The transcatheter aortic valve replacement device having a double-sided locking function according to claim 13, characterized in that the extension of the minor axis of the elliptical structure is parallel to the axis of the through hole, and the extension of the major axis of the elliptical structure is located on the tangent plane of the corresponding inlet end mesh.

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