Heart valve prosthesis stent and heart valve prosthesis

Abstract

The invention provides an artificial heart valve stent and an artificial heart valve prosthesis, and relates to the field of medical instruments, the artificial heart valve stent comprises a stent main body, a stent outflow section and a bending arm; the near end of the stent outflow section and the far end of the stent main body are integrally formed; the bent arm is arranged on the support body and extends in the circumferential direction of the support body, the bent arm is provided with a bent arm connecting end and a bent arm free end in the circumferential direction of the support body, the bent arm connecting end and the support body are fixedly connected or integrally formed, and the bent arm free end and the support body are spaced. The heart valve prosthesis prosthesis comprises an inner stent and an outer stent, and the inner stent or the outer stent is the heart valve prosthesis stent. According to the artificial valve, the risk of perivalvular leakage after the artificial valve is implanted in an interventional mitral valve replacement operation can be reduced.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and in particular to an artificial heart valve stent and an artificial heart valve prosthesis. Background Technology

[0002] The mitral valve, located between the left atrium and left ventricle, consists of leaflets (anterior and posterior), annulus, and subvalvular structures (chordae tendineae and papillary muscles). The mitral valve acts as a one-way valve in cardiac blood flow: when the left ventricle relaxes, the mitral valve leaflets open, allowing blood to flow from the left atrium to the left ventricle; when the left ventricle contracts, the mitral valve leaflets close, preventing blood from flowing from the left ventricle to the left atrium. When the mitral valve is diseased, the leaflets cannot open and close properly, resulting in reverse flow of ventricular blood into the atrium, a condition known as mitral regurgitation. Untreated mitral regurgitation can seriously endanger a patient's life and health, gradually progressing to heart failure and death.

[0003] With the continuous development of mitral regurgitation treatment technology, interventional mitral valve replacement has gradually become a treatment option for mitral regurgitation. That is, for patients with severe mitral valve disease that cannot be repaired, an artificial heart valve prosthesis can be implanted through a catheter to replace the original valve. However, during implantation, because the mitral valve annulus is D-shaped and dynamically changes with myocardial contraction and relaxation, this anatomical feature easily leads to paravalvular leakage. Summary of the Invention

[0004] The purpose of this application is to provide an artificial heart valve stent and an artificial heart valve prosthesis to reduce the risk of paravalvular leakage after artificial valve implantation in interventional mitral valve replacement surgery.

[0005] To achieve the above objectives, the embodiments of this application adopt the following technical solutions: This application provides an artificial heart valve stent, including a stent body, a stent outflow section, and a curved arm; the proximal end of the stent outflow section is integrally formed with the distal end of the stent body; the curved arm is disposed on the stent body and extends circumferentially along the stent body, and along the circumferential direction of the stent body, the curved arm has a curved arm connecting end and a curved arm free end, the curved arm connecting end is fixedly connected to or integrally formed with the stent body, and the curved arm free end is spaced apart from the stent body.

[0006] In an optional embodiment, the artificial heart valve stent is an external stent, including an external stent body and an external stent outflow section, wherein: the external stent as a whole is a circumferentially continuous circumferentially closed structure, the curved arm is located outside the external stent body, its curved arm connecting end is fixedly connected to or integrally formed with the external stent body, and its curved arm free end is spaced apart from the external stent body, so that a semi-enclosed area for capturing the anterior leaflet of the heart is formed between the curved arm and the outer peripheral surface of the external stent body.

[0007] In an optional embodiment, the artificial heart valve stent is an external stent, comprising an external stent body and an external stent outflow section, wherein: the external stent as a whole is a circumferentially non-fully enclosed structure with a fracture opening in the circumferential direction, with the parts of the external stent body located on both sides of the fracture opening as the two free ends in the circumferential direction of the external stent body; the curved arm is located at the fracture opening, and its curved arm connecting end is fixedly connected to or integrally formed with one free end in the circumferential direction of the external stent body, and its curved arm free end is spaced apart from the other free end in the circumferential direction of the external stent body.

[0008] In an optional embodiment, the outer support body is provided with barbs extending outward from the outer support body, and the angle θ of the barbs relative to the outer peripheral surface of the outer support body satisfies: 0°≤θ≤40°; the length L2 of the barbs satisfies: 2mm≤L2≤4mm; And / or, the outer support body is provided with barbs extending outward from the outer support body, and the minimum distance r between the proximal end of the barb and the outer support body along the radial direction of the outer support satisfies: 0≤r≤4mm; the included angle Φ between the barb and the outer peripheral surface of the outer support body satisfies: -30°≤Φ≤30°.

[0009] In an optional embodiment, the artificial heart valve stent is an internal stent, which includes an internal stent inlet section, an internal stent body, and an internal stent outlet section connected sequentially from the proximal end to the distal end. The internal stent inlet section extends proximally relative to the internal stent body and radially outward. The curved arm is located outside the inner stent body and extends circumferentially along the inner stent body. Its curved arm connecting end is fixedly connected to or integrally formed with the inner stent body, and its free end is spaced apart from the inner stent body so that a semi-enclosed area for capturing the anterior leaflet of the heart is formed between the curved arm and the outer peripheral surface of the inner stent body.

[0010] In an optional embodiment, the artificial heart valve stent further includes an artificial valve, which is fixedly connected inside the stent body, and the inflow section of the stent is D-shaped like a saddle in its free state.

[0011] In an optional embodiment, with the axial direction of the stent as the height direction, its proximal end is the upper end and its distal end is the lower end. Simultaneously, the portion of the stent inlet segment that aligns with the anterior leaflet of the heart after implantation is defined as the anterior portion of the stent inlet segment; the portion that aligns with the posterior leaflet of the heart after implantation is defined as the posterior portion of the stent inlet segment; and the portion of the stent inlet segment located between the anterior and posterior portions is defined as the lateral portion of the stent inlet segment. Therefore: The height of the front part of the internal stent inflow section is greater than the height of the rear part of the internal stent inflow section, which is greater than the height of the side part of the internal stent inflow section.

[0012] In an optional embodiment, along the circumferential surface of the support body: the curved arm is provided with a hollow portion extending circumferentially along the support body; And / or, along the radial circular section of the support body: the portion of the bent arm near its free end is arc-shaped along the circumference of the support body, and along the circumferential surface of the support body: the portion of the bent arm near its free end is wavy along the circumference of the support body. And / or, along the radial circular cross-section of the support body, the end of the free end of the bent arm is raised toward the side opposite to the support body to form a flange; And / or, both the bracket body and the curved arm connecting end are provided with curved arm connecting holes, and the curved arm connecting end is stitched or riveted to the bracket body through the curved arm connecting holes.

[0013] In an optional embodiment, along the radial circular cross-section of the support body: the curved arm includes a curved arm connecting end, a transition arc segment, a parallel arc segment, and a curved arm free end connected in sequence; the parallel arc segment is parallel to the outer peripheral surface of the support body; and / or, the curved arm and the support body have a distance d in the direction along the radial direction of the support body, the distance d satisfying: 0≤d≤5mm.

[0014] In a second aspect, the present invention provides an artificial heart valve prosthesis, wherein the artificial heart valve prosthesis comprises an internal stent and an artificial heart valve stent provided in any optional embodiment of the first aspect, or, the artificial heart valve prosthesis comprises an external stent and an artificial heart valve stent provided in any optional embodiment of the first aspect; wherein: There is a radial distance R between the outer support body and the inner support body, and the radial distance R satisfies: 0≤R≤10mm; And / or, there is an axial distance L1 between the upper end of the outer support body and the inflow section of the inner support, wherein the axial distance L1 satisfies: 0≤L1≤5mm; And / or, the outer support body is provided with barbs extending outward from the outer support body, and the distance L3 between the proximal end of the barb and the proximal end of the inner support inflow section along the axial direction of the inner support satisfies: 0≤L3≤9mm.

[0015] In particular, in the embodiments of this application, "and / or" means that the first feature before "and / or" and the second feature after "and / or" include the following specific setting methods: (1) only the first feature is set, and the second feature is not set; (2) only the second feature is set, and the first feature is not set; (3) the first feature and the second feature are set at the same time.

[0016] The embodiments of this application can achieve at least the following beneficial effects: The artificial heart valve stent provided in this application embodiment can capture the anterior leaflet during implantation using a curved arm, thereby enhancing the seal between the valve annulus and the artificial leaflet on the stent after implantation and preventing paravalvular leakage. The artificial heart valve prosthesis includes the aforementioned artificial heart valve stent and can at least achieve the same functions as described above.

[0017] For more specific structures and usage methods of the embodiments of this application, please refer to the detailed description in the Detailed Description of the Embodiments section of this application. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the specific embodiments of this application or the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0019] Figure 1 An anatomical view of the human heart structure; Figure 2 This is an isometric schematic diagram of the overall structure of the external stent in an artificial heart valve prosthesis provided in Embodiment 1 of this application; Figure 3 for Figure 2 Top view of the overall structure of the external stent in the provided artificial heart valve prosthesis; Figure 4 for Figure 2 Side view of the overall structure of the external stent in the provided artificial heart valve prosthesis; Figure 5 An isometric schematic diagram of the overall structure of the internal stent in another artificial heart valve prosthesis provided in Embodiment 2 of this application; Figure 6 For this application Figure 5 Top view of the overall structure of the internal stent in the provided artificial heart valve prosthesis; Figure 7 For this application Figure 5 Side view of the overall structure of the internal stent in the provided artificial heart valve prosthesis. Figure 1 ; Figure 8 For this application Figure 5 Side view of the overall structure of the internal stent in the provided artificial heart valve prosthesis. Figure 2 ; Figure 9 For this application Figure 5 Side view of the overall structure of the internal stent in the provided artificial heart valve prosthesis. Figure 3 ; Figure 10 For this application Figure 5 A schematic diagram of one possible structure of the curved arm in the provided artificial heart valve prosthesis; Figure 11 For this application Figure 5 A schematic diagram of another optional structure for the curved arm in the provided artificial heart valve prosthesis; Figure 12 for Figure 11 The radial cross-sectional view of the main assembly structure of the curved arm and the inner support shown is shown. Figure 13 For this application Figure 5 Axonometric view of the overall structure of the external stent in the provided artificial heart valve prosthesis; Figure 14 For this application Figure 5 Axonometric view of the stent structure composed of the inner and outer stents in the provided artificial heart valve prosthesis; Figure 15 For this application Figure 5 A top view of the stent structure composed of the inner and outer stents in the provided artificial heart valve prosthesis; Figure 16 For this application Figure 5 A side view of the stent structure composed of an inner stent and an outer stent in the provided artificial heart valve prosthesis. Figure 1 ; Figure 17 For this application Figure 5 A side view of the stent structure composed of an inner stent and an outer stent in the provided artificial heart valve prosthesis. Figure 2 .

[0020] Icons: 100 - Internal stent; 110 - Internal stent inflow section; 120 - Internal stent body; 130 - Internal stent outflow section; 200 - Bending arm; 201 - Hollowed-out section; 210 - Bending arm connecting end; 220 - Transition arc section; 230 - Parallel arc section; 240 - Free end of bending arm; 300 - Outer support; 310 - Outer support body; 320 - Outer support outlet section; 330 - Fixing element; 340 - Barb; 350 - Barb. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0022] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0023] It should be noted that similar labels and letters in the accompanying drawings indicate similar items. Therefore, once an item is defined in one accompanying drawing, it does not need to be further defined and explained in subsequent accompanying drawings.

[0024] In the description of this application, it should be noted that: Unless otherwise expressly specified and limited, the terms "setup," "installation," and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0025] The terms “proximal end,” “distal end,” “axial,” “radial,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is usually placed when in use. They are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0026] The terms “first”, “second”, etc. are used only for distinguishing descriptions and do not indicate totality or relative position in time and / or space, and should not be construed as indicating or implying relative importance.

[0027] Below, with the artificial heart valve prosthesis implanted into the patient's body, the inflow end of the artificial heart valve prosthesis is the proximal end of the artificial heart valve prosthesis, and the outflow end of the artificial heart valve prosthesis is the distal end of the artificial heart valve prosthesis. Some embodiments of this application will be described in detail with reference to the accompanying drawings.

[0028] Reference Figure 1 The mitral valve, located between the left atrium and left ventricle, consists of leaflets (anterior and posterior), annulus, and subvalvular structures (chordae tendineae and papillary muscles). The mitral valve acts as a one-way valve in cardiac blood flow: when the left ventricle relaxes, the mitral valve leaflets open, allowing blood to flow from the left atrium to the left ventricle; when the left ventricle contracts, the mitral valve leaflets close, preventing blood from flowing from the left ventricle to the left atrium. When the mitral valve is diseased, the leaflets cannot open and close properly, resulting in reverse ventricular blood flow into the atrium, a condition known as mitral regurgitation. Untreated mitral regurgitation can seriously endanger a patient's life, gradually progressing to heart failure and death.

[0029] With the continuous development of mitral regurgitation treatment technology, interventional mitral valve replacement has gradually become a treatment option for mitral regurgitation. That is, for patients with severe mitral valve disease that cannot be repaired, an artificial heart valve prosthesis can be implanted through a catheter to replace the original valve. However, during implantation, because the mitral valve annulus is D-shaped and dynamically changes with myocardial contraction and relaxation, this anatomical feature easily leads to paravalvular leakage.

[0030] Based on this, this application provides an artificial heart valve stent and an artificial heart valve prosthesis, as shown in the reference. Figures 1 to 17 The artificial heart valve stent includes a stent body, a stent outflow section, and a curved arm 200. The proximal end of the stent outflow section is integrally formed with the distal end of the stent body. The curved arm 200 is disposed on the stent body and extends circumferentially along the stent body. Along the circumferential direction of the stent body, the curved arm 200 has a curved arm connecting end 210 and a curved arm free end 240. The curved arm connecting end 210 is fixedly connected to or integrally formed with the stent body, and the curved arm free end 240 is spaced apart from the stent body. The artificial heart valve prosthesis includes an external stent and an internal stent. One of the external stent and the internal stent is specially designed to form the aforementioned artificial heart valve stent, while the structural shape of the other is not specifically limited.

[0031] During assembly, the internal stent is usually used in conjunction with the external stent. The artificial heart valve prosthesis, consisting of the external and internal stents, is implanted together into the mitral valve position using a delivery system (including a delivery device, guide wire, etc.) to replace the patient's original mitral valve.

[0032] refer to Figures 14 to 17Taking a combination of an external stent 300 and an internal stent 100 as an example, the implantation process of an artificial heart valve prosthesis is illustrated. The external stent 300 includes an external stent body 310, an external stent outflow section 320, and a fixation member 330 connected sequentially from proximal to distal. The distal end of the external stent outflow section 320 is fixedly connected to or integrally formed with the distal end of the internal stent outflow section 130. The fixation member 330 is used for assembly with a delivery device, forming a delivery system with a guide wire, etc. The delivery device generally includes an outer sheath, a push tube, and a central tube with a guide head, all sleeved from the outside in. It is also equipped with a post-release assembly, which has various optional structural types, including but not limited to a post-release wire, a post-release membrane sheath, or a push-pull tube with a limiting rod at the front end, or a structure that mates with a slot at the rear end of the guide head, etc. This part is prior art and will not be described further. The specific implantation process is as follows: During assembly, the fixing member 330 at the distal end of the outer support 300 is connected to the anchoring member inside the outer sheath of the conveyor (the fixing member 330 on the outer support 300 is existing technology; the fixing member 330 has various optional structural types that can be matched with the anchoring member inside the outer sheath of the conveyor, which will not be elaborated here). The outer support 300 and the inner support 100 are radially compressed and drawn into the outer sheath of the conveyor. At the same time, the proximal end of the inner support inflow section 110 and the proximal end of the outer support body 310 are radially constrained by the rear release component of the conveyor. At this time, both the inner support 100 and the outer support 300 are located inside the outer sheath of the conveyor. Relative to the outer sheath of the conveyor, both the inner support 100 and the outer support 300 have their proximal ends facing forward and their distal ends facing backward, and are located in front of the push tube. The proximal ends of the inner support 100 and the outer support 300 are both radially compressed in the rear release component. During implantation, the tip of the delivery device's outer sheath is pushed from the ventricle towards the atrium to the designated position. Then, in the first step, the outer sheath is retracted relative to the delivery tube or pushed forward relative to the outer sheath until the curved arm 200 is released. At this time, the proximal end of the inner stent 100 (inner stent inlet section 110) and the proximal end of the outer stent body 310 are still radially compressed in the post-release assembly, so that the opening of the free end 240 of the curved arm at one end along the circumference of the corresponding stent body faces the anterior leaflet of the heart. In the second step, the delivery device is rotated so that the anterior leaflet is confined inside the curved arm 200. The third step involves releasing the release assembly, including the proximal end of the inner stent 100 (inner stent inlet section 110) and the proximal end of the outer stent body 310. If the proximal end of the outer stent body 310 is also equipped with an anchoring structure, this anchoring structure will be released simultaneously and anchored to the patient's original leaflet. Finally, the outer sheath is withdrawn relative to the push tube or the push tube is pushed forward relative to the outer sheath until the artificial heart valve prosthesis is completely released. The connection between the fixation member 330 at the distal end of the outer stent 300 and the anchoring member inside the outer sheath of the delivery device is released, and the entire delivery device is withdrawn from the patient's body.

[0033] If the femoral entry route is used, the release logic is similar to that described above. When the artificial heart valve prosthesis is used for the tricuspid valve, the release logic is similar depending on the implantation route.

[0034] The artificial heart valve stent provided in this application can capture the anterior leaflet of the heart during implantation using its curved arm 200. After implantation, the anterior leaflet is squeezed between the curved arm 200 and the stent body (inner stent body or outer stent body), which enhances the sealing between the valve annulus and the artificial leaflet inside the artificial heart valve prosthesis after implantation, thereby preventing paravalvular leakage.

[0035] Specifically, this application includes the following specific design schemes: Example 1 This embodiment provides an artificial heart valve stent, which is an external stent, and together with an internal stent and artificial valve leaflets connected inside the internal stent, forms an artificial heart valve prosthesis. Specifically, refer to... Figures 2 to 4 The artificial heart valve stent is an external stent 300, and there are no specific restrictions on the structural form of the internal stent.

[0036] like Figures 2 to 4 As shown, the artificial heart valve stent (external stent 300) includes an external stent body 310 and an external stent outflow section 320. The proximal end of the external stent outflow section 320 is integrally formed with the distal end of the external stent body 310. A curved arm 200 is disposed on the external stent body 310 and extends circumferentially along the external stent body 310. Along the circumferential direction of the external stent body 310, the curved arm 200 has a curved arm connecting end 210 and a curved arm free end 240. The curved arm connecting end 210 is fixedly connected to or integrally formed with the external stent body 310, and the curved arm free end 240 is spaced apart from the external stent body 310.

[0037] The outer support 300 can be a circumferentially continuous, circumferentially closed structure, or a circumferentially non-fully closed structure with a fracture point in the circumferential direction. When the outer support 300 is a circumferentially continuous, circumferentially closed structure (not shown, but can be referenced),... Figures 5-9 The structure of the stent shown is similar in appearance when the outer stent 300 is a continuous, circumferentially closed structure. The curved arm 200 is located outside the outer stent body 310. The curved arm connecting end 210 is fixedly connected to or integrally formed with the outer stent body 310. The free end 240 of the curved arm is spaced apart from the outer stent body 310, so that a semi-enclosed area for capturing the anterior lobe of the heart is formed between the curved arm 200 and the outer peripheral surface of the outer stent body 310 during implantation. After implantation, the anterior lobe is compressed between the curved arm and the outer peripheral surface of the outer stent body 310. When the outer stent body 310 is a circumferentially non-fully closed structure with a circumferential fracture, such as... Figures 2 to 4As shown, the parts of the outer stent body 310 located on both sides of the fracture opening are the two free ends of the outer stent body 310 in the circumferential direction: the curved arm 200 is located at the fracture opening, and its curved arm connecting end 210 is fixedly connected to or integrally formed with one free end of the outer stent body 310 in the circumferential direction. Its curved arm free end 240 is spaced apart from the other free end of the outer stent body 310 in the circumferential direction. After implantation, the anterior leaf is squeezed between the curved arm and the outer circumferential surface of the inner stent body.

[0038] Specifically, considering that during surgery, the complete external stent occupies the area of ​​the left ventricular outflow tract, and the mitral valve leaflets only have anterior and posterior leaflets, after implantation, the valve prosthesis compresses the aorta, causing a reduction in the opening area of ​​the left ventricular outflow tract, an increase in the pressure gradient, and reduced left ventricular emptying, thereby leading to a decrease in cardiac output and potentially causing left ventricular outflow tract obstruction. Therefore, in some preferred embodiments of this example, the external stent 300 is designed as a circumferentially non-fully enclosed structure with a circumferential fracture opening. The proximal ends of its two circumferentially free ends are fixedly connected to or integrally formed with the inner stent body. The specific fixing methods include, but are not limited to, providing connection holes at the proximal ends of the inner stent body and the two circumferentially free ends of the external stent 300, with the connection holes being connected by sutures or rivets. In this optional embodiment, the external stent 300 is a non-fully enclosed structure with a circumferential fracture opening. This structure is not constrained by the circumferential ring and can better conform to the patient's original valve annulus structure, which helps to further reduce the risk of left ventricular outflow tract obstruction after implantation. Meanwhile, compared with fully enclosed external stents, non-fully enclosed external stents reduce stent material and covering material, which helps to reduce the difficulty of valve insertion or reduce the diameter of the delivery system sheath under the same sheath diameter.

[0039] In this embodiment, regardless of whether the outer support 300 is a circumferentially continuous closed structure or a circumferentially non-closed structure with a fracture point in the circumferential direction, any one or more of the following optional structures can be further designed: Optionally, the outer support body 310 is provided with barbs 340 extending outward from the outer support body 310. The angle θ of the barbs 340 outward relative to the outer peripheral surface of the outer support body 310 satisfies: 0°≤θ≤40°, where θ can be any angle within the range of 0°, 5°, 10°, 20°, 30°, 40°, or 0°~40°, preferably 10°≤θ≤30°. Optionally, the length L2 of the barbs 340 satisfies: 2mm≤L2≤4mm, where L2 can be any length within the range of 2mm, 2.5mm, 3mm, 3.5mm, 4mm, or 2mm~4mm, preferably 2.5mm≤L2≤3.5mm. In this optional embodiment, during implantation, the barbs 340 can be released to pierce the original valve leaflet, further increasing the anchoring stability of the artificial heart valve prosthesis in the patient's body.

[0040] Optionally, the outer stent body 310 is provided with an anchoring structure—a barb 350—extending outward from the outer stent body 310. After implantation, the barb 350 grips the valve leaflet to prevent displacement of the artificial heart valve prosthesis during release. After release, the barb 350 abuts against the valve annulus to further prevent displacement of the artificial heart valve prosthesis after implantation. The anchoring is simple and precise, preventing various types of displacement. Further, the minimum distance r between the proximal end of the barb 350 and the outer stent body 310 in the radial direction along the outer stent 300 satisfies the numerical range: 0 ≤ r ≤ 4 mm, where r can be selected from 0 mm, 1 mm, 1.5 mm, 3 mm, 3.5 mm, or 4 mm, or any length within the range of 0~4 mm. Preferably, 1 mm ≤ r ≤ 3 mm. Optionally, the included angle Φ between the barb 350 and the outer circumferential surface of the outer stent body 310 satisfies the numerical range: -30° ≤ Φ ≤ 30°, where Φ can be selected from -30°. Any angle within the range of °, -10°, 0°, 10°, 30°, or -30° to 30°, where a negative value indicates that a point on the barb 350 is radially located inside the outer stent body 310. Applicable structures include, but are not limited to, situations where the root of the barb 350 (the end closest to the outer stent body 310) is connected to the inner surface of the outer stent body 310, and then folds through the outer stent body 310 to the outside of the outer stent body 310. Preferably, 5° ≤ Φ ≤ 25°. The barb 350 is preferably designed as a closed ring to reduce damage to the patient's valve annulus, original valve leaflet, and original cardiac tissue.

[0041] Optionally, along the circumference of the outer support body 310, the curved arm 200 is provided with a hollow portion 201 extending circumferentially along the outer support body 310; this facilitates manufacturing and reduces weight, thus lessening the burden on the user. For example, but not limited to, such as... Figure 10 and Figure 11 As shown, the curved arm 200 is actually formed by folding a long strip structure in half from the part near the midpoint. The aforementioned hollow part 201 is formed between the two folded parts. Furthermore, the lengths of the two folded parts can be different. That is, the curved arm connecting end 210 actually includes two staggered endpoints. The outer support body 310 is usually in the shape of a grid. These two staggered endpoints are fixedly connected to any two intersections of the grid structure to achieve a stable connection.

[0042] Optionally, along the radial circular section of the outer support body 310, the portion of the bent arm 200 near its free end 240 is arc-shaped along the circumference of the outer support body 310, and along the circumferential surface of the outer support body 310, the portion of the bent arm 200 near its free end 240 is wavy along the circumference of the outer support body 310. This structure allows the curved arm 200 to automatically fold circumferentially along the wave-shaped configuration when the external stent 300 is radially compressed and loaded inside the delivery sheath. This reduces the circumference after folding while maintaining the same radial thickness. This configuration reduces the area of ​​the folded region between the curved arm 200 and the external stent body 310 when the external stent 300 is radially compressed. This helps to reduce the overall outer diameter of the external stent 300 after radial compression (i.e., reduces the overall outer diameter of the artificial heart valve prosthesis). This also reduces the requirement for the outer diameter of the delivery sheath, which is beneficial for using a smaller diameter delivery sheath for interventional surgery. It also makes it easier for the delivery sheath to navigate through tortuous blood vessels, resulting in a smoother surgical procedure and reducing damage to the patient's blood vessels or organ tissues.

[0043] Optionally, along the radial circular cross-section of the outer support body 310, the end of the free end 240 of the bent arm is raised towards the side away from the outer support body 310 to form a flange, so that the bent arm 200 can more easily bypass the tendon cord and restrict the front leaf within the semi-enclosed area formed between the bent arm 200 and the outer peripheral surface of the outer support body 310, making the operation simpler and reducing damage to the tendon cord. Furthermore, the angle α between the raised part of the free end 240 of the bent arm and the tangent line on the radial circular cross-section of the outer support body 310 at the root of the raised part of the free end 240 of the bent arm (the raised part is closer to the end point on the side of the outer support body 310) satisfies: 0° < α ≤ 60°, α can be selected from 0.5°, 15°, 30°, 40°, 60° or any angle within the range of greater than 0° and less than or equal to 60°, preferably 10° < α ≤ 30°.

[0044] Optionally, both the outer support body 310 and the curved arm connecting end 210 are provided with curved arm connecting holes, and the curved arm connecting end 210 is sewn or riveted to the outer support body 310 through the curved arm connecting holes.

[0045] Specifically, when the outer support 300 is a circumferentially continuous closed structure, in an optional embodiment of this structure, along the radial circular cross-section of the outer support body 310: the curved arm 200 includes a curved arm connecting end 210, a transition arc segment 220, a parallel arc segment 230, and a curved arm free end 240 connected in sequence; the parallel arc segment 230 is parallel to the outer circumferential surface of the outer support body 310; furthermore, in an optional embodiment of this structure, the curved arm 200 and the outer support body 310 have a distance d in the radial direction of the outer support body 310, and the distance d satisfies: 0≤d≤5mm, d can be selected from 0mm, 1mm, 2.5mm, 3mm, 3.5mm, 5mm or any length within the range of 0~5mm, preferably 2.5≤d≤3.5mm.

[0046] Example 2 This embodiment provides an artificial heart valve stent, which is an inner stent, and together with an outer stent and artificial leaflets connected inside the inner stent, it forms an artificial heart valve prosthesis. Specifically, refer to... Figures 5 to 9 The artificial heart valve stent is an internal stent 100, and there are no specific restrictions on the structural form of the external stent.

[0047] like Figures 5 to 9 As shown, the artificial heart valve stent (inner stent 100) includes an inner stent body 120 and an inner stent outflow section 130. The proximal end of the inner stent outflow section 130 is integrally formed with the distal end of the inner stent body 120. A curved arm 200 is disposed on the inner stent body 120 and extends circumferentially along the inner stent body 120. Along the circumferential direction of the inner stent body 120, the curved arm 200 has a curved arm connecting end 210 and a curved arm free end 240. The curved arm connecting end 210 is fixedly connected to or integrally formed with the inner stent body 120, and the curved arm free end 240 is spaced apart from the inner stent body 120.

[0048] More specifically, the stent 100 includes a stent inflow section 110, a stent body 120, and a stent outflow section 130 connected sequentially from proximal to distal. The stent inflow section 110 extends proximally and radially outward relative to the stent body 120. A curved arm 200 is disposed outside the stent body 120 and extends circumferentially along the stent body 120. Its curved arm connecting end 210 is fixedly connected to or integrally formed with the stent body 120. Its curved arm free end 240 is spaced apart from the stent body 120 so that a semi-enclosed area for capturing the anterior leaflet of the heart is formed between the curved arm 200 and the outer peripheral surface of the stent body 120. After implantation, the anterior leaflet is compressed between the curved arm 200 and the outer peripheral surface of the stent body 120.

[0049] In this embodiment, optionally, the artificial heart valve stent further includes an artificial valve, which is fixedly connected inside the inner stent body 120. The inflow section 110 of the inner stent is D-shaped in its free state. Designing the inflow section 110 to be D-shaped in its free state allows it to adapt to the dynamic saddle-shaped three-dimensional structure of the human valve annulus, avoiding a series of problems caused by the valve annulus size of the artificial heart valve prosthesis used in the prior art to prevent paravalvular leakage being larger than the human valve annulus size, and reducing the risk of left ventricular outflow tract obstruction after the artificial heart valve prosthesis is implanted in the human body.

[0050] For the aforementioned stent inlet segment 110 to be D-shaped in its free state, more specifically, taking the axis of the stent 100 as the height direction, its proximal end is the upper end and its distal end is the lower end. Simultaneously, the part of the stent inlet segment 110 that matches the anterior leaf of the heart after implantation is the anterior part of the stent inlet segment 110, the part that matches the posterior leaf of the heart after implantation is the posterior part of the stent inlet segment 110, and the part of the stent inlet segment 110 located between the anterior and posterior parts is the lateral part of the stent inlet segment 110. Therefore, the height of the anterior part of the stent inlet segment 110 > the height of the posterior part of the stent inlet segment 110 > the height of the lateral part of the stent inlet segment 110. This structure satisfies the condition that "the stent inlet segment 110 is D-shaped in its free state."

[0051] Optionally, along the circumference of the support body: the curved arm 200 is provided with a hollow portion 201 extending circumferentially along the inner support body 120; this facilitates manufacturing and reduces weight, thus lessening the burden on the user. For example, but not limited to, as shown in Figure 10 and... Figure 11 As shown, the curved arm 200 is actually formed by folding a long strip structure in half from the part near the midpoint. The aforementioned hollow part 201 is formed between the two folded parts. Furthermore, the lengths of the two folded parts can be different. That is, the curved arm connecting end 210 actually includes two staggered endpoints. The inner support body 120 is usually in the shape of a grid. These two staggered endpoints are fixedly connected to any two intersections of the grid structure to achieve a stable connection.

[0052] Optionally, along the radial circular cross-section of the stent body: the portion of the curved arm 200 near its free end 240 is arc-shaped along the circumference of the inner stent body 120, and along the circumferential surface of the stent body: the portion of the curved arm near its free end 240 is wavy along the circumference of the stent body. This structure allows the curved arm 200 to automatically fold circumferentially along the wavy configuration when the inner stent 100 is radially compressed and loaded inside the delivery sheath, thereby reducing the circumference after folding while maintaining the same radial thickness. This structural configuration reduces the area of ​​the folded region between the curved arm 200 and the inner stent body 120 when the outer stent 300 is radially compressed, which helps to reduce the overall outer diameter of the inner stent 100 after radial compression (i.e., reducing the overall outer diameter of the artificial heart valve prosthesis). This also reduces the requirement for the outer diameter of the delivery sheath, which is beneficial for using a smaller diameter delivery sheath for interventional surgery. It also makes it easier for the delivery sheath to navigate through tortuous blood vessels, resulting in a smoother surgical procedure and reducing damage to the patient's blood vessels or organ tissues.

[0053] Optionally, along the radial circular cross-section of the inner support body 120, the end of the free end 240 of the bent arm is raised towards the side away from the inner support body 120 to form a flange, so that the bent arm 200 can more easily bypass the tendon cord and restrict the anterior leaf within the semi-enclosed area formed between the bent arm 200 and the outer peripheral surface of the inner support body 120, making the operation simpler and reducing damage to the tendon cord. Furthermore, the angle α between the raised part of the free end 240 of the bent arm and the tangent line of the root of the raised part of the free end 240 of the bent arm (the raised part is closer to the end point on the side of the outer support body 310) on the radial circular cross-section of the inner support body 120 satisfies: 0° < α ≤ 60°, α can be selected from 0.5°, 15°, 30°, 40°, 60° or any angle within the range of greater than 0° and less than or equal to 60°, preferably 10° < α ≤ 30°.

[0054] Optionally, both the inner support body 120 and the curved arm connecting end 210 are provided with curved arm connecting holes, and the curved arm connecting end 210 is sewn or riveted to the inner support body 120 through the curved arm connecting holes.

[0055] Alternatively, along the radial circular cross-section of the inner support body 120, the curved arm 200 includes a curved arm connecting end 210, a transition arc segment 220, a parallel arc segment 230, and a curved arm free end 240 connected in sequence; the parallel arc segment 230 is parallel to the outer peripheral surface of the inner support body 120; furthermore, in an optional embodiment of this structure, the curved arm 200 and the inner support body 120 have a distance d in the radial direction along the inner support body 120, the distance d satisfying: 0≤d≤5mm, the distance d satisfying: 0≤d≤5mm, d can be any length within the range of 0mm, 1mm, 2.5mm, 3mm, 3.5mm, 5mm or 0~5mm, preferably 2.5≤d≤3.5mm.

[0056] Example 3 This embodiment provides an artificial heart valve prosthesis, including an artificial heart valve stent as an external stent 300 in any optional embodiment of Embodiment 1, and an internal stent of any optional structural form.

[0057] The distal end of the outer stent outlet section 320 is fixedly connected to or integrally formed with the distal end of the inner stent outlet section 130. An inner stent inlet section membrane is connected to the inner stent inlet section 110, an inner stent body membrane is connected to the inner stent body 120, and an outer stent body membrane is connected to the outer stent body 310; an artificial leaflet is connected inside the inner stent. A fastener 330 for connection to the delivery system is connected to the distal end of the outer stent body.

[0058] In addition, in an optional embodiment of this invention, the artificial heart valve prosthesis also includes a connecting membrane; the inner stent body membrane, the inner stent inflow section membrane, the connecting membrane, and the outer stent body membrane are interconnected to form a closed membrane pouch structure. The membrane pouch structure forms a closed space inside. When the artificial heart valve prosthesis is subjected to radial compression, the closed space pulls the proximal end of the outer stent body 310 to contract radially, and the angle between the inner stent inflow end 110 and the horizontal becomes smaller, thereby further improving the anti-peripheral leakage effect after implantation.

[0059] In an optional embodiment of this example, there is a radial distance R between the outer support body 310 and the inner support body 120. The radial distance R satisfies: 0≤R≤10mm. R can be selected from 0mm, 3mm, 5mm, 8mm, 10mm or any length within the range of 0~10mm. Preferably, 1mm≤R≤5mm.

[0060] In an optional embodiment of this example, there is an axial distance L1 between the upper end of the outer support body 310 and the inner support inflow section 110. The axial distance L1 satisfies: 0≤L1≤5mm. L1 can be selected as 0mm, 2mm, 4mm, 5mm or any length within the range of 0~5mm. Preferably, 1mm≤L1≤4mm.

[0061] In an optional embodiment of this invention, the outer stent body 310 is provided with an anchoring structure—a barb 350—extending outward from the outer stent body 310. After implantation, the barb 350 grips the valve leaflet to prevent displacement of the artificial heart valve prosthesis during release. After release, the barb 350 abuts against the valve annulus to further prevent displacement of the artificial heart valve prosthesis after implantation. The anchoring is simple and the positioning is accurate, preventing various types of displacement. Furthermore, the distance L3 between the proximal end of the barb 350 and the proximal end of the inner stent inflow section 110 along the axial direction of the inner stent 100 satisfies: 0≤L3≤9mm. L3 can be selected from any length within the range of 1mm, 4.5mm, 6mm, 8mm, or 9mm, or 0~9mm. Preferably, 1mm≤L3≤8mm. Optionally, the minimum distance r between the proximal end of the barb 350 and the outer support body 310 in the radial direction along the outer support 300 satisfies the following numerical range: 0 ≤ r ≤ 4 mm, where r can be any length within the range of 0 mm, 1 mm, 1.5 mm, 3 mm, 3.5 mm, or 4 mm, preferably 1 mm ≤ r ≤ 3 mm; Optionally, the included angle Φ between the barb 350 and the outer peripheral surface of the outer support body 310 satisfies the following numerical range: -30° ≤ Φ ≤ 30°, where Φ can be -30°. The angle can be any angle within the range of -10°, 0°, 10°, 30°, or -30° to 30°. A negative value indicates that a point on the barb 350 is radially located inside the outer stent body 310. Applicable structures include, but are not limited to, situations where the root of the barb 350 (the end closest to the outer stent body 310) connects to the inner surface of the outer stent body 310 and then folds through the outer stent body 310 to the outside. Preferably, 5° ≤ Φ ≤ 25°. The barb 350 is preferably designed as a closed ring to reduce damage to the patient's valve annulus, original valve leaflets, and original cardiac tissue.

[0062] Optionally, the outer support body 310 is provided with barbs 340 extending outward from the outer support body 310. The angle θ of the barbs 340 outward relative to the outer peripheral surface of the outer support body 310 satisfies: 0°≤θ≤40°, where θ can be any angle within the range of 0°, 5°, 10°, 20°, 30°, 40°, or 0°~40°, preferably 10°≤θ≤30°. Optionally, the length L2 of the barbs 340 satisfies: 2mm≤L2≤4mm, where L2 can be any length within the range of 2mm, 2.5mm, 3mm, 3.5mm, 4mm, or 2mm~4mm, preferably 2.5mm≤L2≤3.5mm. In this optional embodiment, during implantation, the barbs 340 can be released to pierce the original valve leaflet, further increasing the anchoring stability of the artificial heart valve prosthesis in the patient's body.

[0063] Example 4 This embodiment provides an artificial heart valve prosthesis, including an artificial heart valve stent as an inner stent 100 in any optional embodiment of Embodiment 2, and an outer stent of any optional structural form.

[0064] The distal end of the outer stent outlet section 320 is fixedly connected to or integrally formed with the distal end of the inner stent outlet section 130. An inner stent inlet section membrane is connected to the inner stent inlet section 110, an inner stent body membrane is connected to the inner stent body 120, and an outer stent body membrane is connected to the outer stent body 310; an artificial leaflet is connected inside the inner stent. A fastener 330 for connection to the delivery system is connected to the distal end of the outer stent body.

[0065] Specifically, considering that during surgery, a complete external stent occupies the area of ​​the left ventricular outflow tract, and that the mitral valve leaflet only has two leaflets (anterior and posterior), after implantation, the valve prosthesis compresses the aorta, causing a reduction in the opening area of ​​the left ventricular outflow tract, an increase in the pressure gradient, and reduced left ventricular emptying, thereby leading to a decrease in cardiac output and potentially causing left ventricular outflow tract obstruction, in some preferred embodiments of this example, a method is adopted... Figure 13 The outer support 300 shown is a circumferentially non-fully enclosed structure with a fracture opening in the circumferential direction. To avoid interference when both the outer support 300 and the inner support 100 have bending arms 200, it is further preferred that only the inner support 100 has bending arms 200, and the outer support 300 does not have bending arms 200. See details... Figures 13 to 17 The proximal ends of the two free ends of the external stent 300 in the circumferential direction are fixedly connected to or integrally formed with the inner stent body 120. The specific fixing methods include, but are not limited to, providing connection holes at the proximal ends of the inner stent body 120 and the two free ends of the external stent 300 in the circumferential direction, and connecting them through sutures or rivets. The external stent 300 includes an external stent body 310, an external stent outflow section 320, and a fixator 330 connected sequentially from proximal to distal. The distal end of the external stent outflow section 320 is fixedly connected to or integrally formed with the distal end of the inner stent outflow section 130, and the fixator 330 is used to connect with the delivery system. In this embodiment, the external stent 300 is a non-fully enclosed structure with a fracture opening in the circumferential direction. This structure is not constrained by the circumferential direction of the annulus, allowing it to better conform to the patient's original valve annulus structure, which helps to further reduce the risk of left ventricular outflow tract obstruction after implantation. Meanwhile, compared with fully enclosed external stents, non-fully enclosed external stents reduce stent material and covering material, which helps to reduce the difficulty of valve retraction or reduce the diameter of the delivery sheath under the same sheath diameter.

[0066] Regardless of the type of external stent used, in the optional implementation of this embodiment, the artificial heart valve prosthesis also includes a connecting membrane; the inner stent body membrane, the inner stent inflow section membrane, the connecting membrane, and the outer stent body membrane are interconnected to form a closed membrane pouch structure. The membrane pouch structure forms a closed space inside. When the artificial heart valve prosthesis is subjected to radial compression, the closed space pulls the proximal end of the outer stent body 310 to contract radially, and the angle between the inner stent inflow end 110 and the horizontal becomes smaller, thereby further improving the anti-peripheral leakage effect after implantation.

[0067] In an optional embodiment of this example, there is a radial distance R between the outer support body 310 and the inner support body 120. The radial distance R satisfies: 0≤R≤10mm. R can be selected from 0mm, 3mm, 5mm, 8mm, 10mm or any length within the range of 0~10mm. Preferably, 1mm≤R≤5mm.

[0068] In an optional embodiment of this example, there is an axial distance L1 between the upper end of the outer stent body 310 and the inner stent inflow section 110. The axial distance L1 satisfies: 0 ≤ L1 ≤ 5 mm. L1 can be selected from 0 mm, 2 mm, 4 mm, 5 mm or any length within the range of 0~5 mm. Preferably, 1 mm ≤ L1 ≤ 4 mm. In an optional embodiment of this example, the outer stent body 310 is provided with an anchoring structure - barb 350 extending outward from the outer stent body 310. After implantation, the barb 350 grips the valve leaflet to prevent displacement of the artificial heart valve prosthesis during release. After release, the barb 350 abuts against the valve annulus to further prevent displacement of the artificial heart valve prosthesis after implantation. The anchoring is simple and the positioning is accurate, preventing various types of displacement. Further, the distance L3 between the proximal end of the barb 350 and the proximal end of the inner support inflow section 110 along the axial direction of the inner support 100 satisfies: 0 ≤ L3 ≤ 9 mm. L3 can be any length within the range of 1 mm, 4.5 mm, 6 mm, 8 mm, or 9 mm, or 0~9 mm. Preferably, 1 mm ≤ L3 ≤ 8 mm. Optionally, the minimum distance r between the proximal end of the barb 350 and the outer support body 310 along the radial direction of the outer support 300 satisfies the numerical range: 0 ≤ r ≤ 4 mm. r can be any length within the range of 0 mm, 1 mm, 1.5 mm, 3 mm, 3.5 mm, or 4 mm, or 0~4 mm. Preferably, 1 mm ≤ r ≤ 3 mm. Optionally, the included angle Φ between the barb 350 and the outer circumferential surface of the outer support body 310 satisfies the numerical range: -30° ≤ Φ ≤ 30°. Φ can be -30°. The angle can be any angle within the range of -10°, 0°, 10°, 30°, or -30° to 30°. A negative value indicates that a point on the barb 350 is radially located inside the outer stent body 310. Applicable structures include, but are not limited to, situations where the root of the barb 350 (the end closest to the outer stent body 310) connects to the inner surface of the outer stent body 310 and then folds through the outer stent body 310 to the outside. Preferably, 5° ≤ Φ ≤ 25°. The barb 350 is preferably designed as a closed ring to reduce damage to the patient's valve annulus, original valve leaflets, and original cardiac tissue.

[0069] Optionally, the outer support body 310 is provided with barbs 340 extending outward from the outer support body 310. The angle θ of the barbs 340 outward relative to the outer peripheral surface of the outer support body 310 satisfies: 0°≤θ≤40°, where θ can be any angle within the range of 0°, 5°, 10°, 20°, 30°, 40°, or 0°~40°, preferably 10°≤θ≤30°. Optionally, the length L2 of the barbs 340 satisfies: 2mm≤L2≤4mm, where L2 can be any length within the range of 2mm, 2.5mm, 3mm, 3.5mm, 4mm, or 2mm~4mm, preferably 2.5mm≤L2≤3.5mm. In this optional embodiment, during implantation, the barbs 340 can be released to pierce the original valve leaflet, further increasing the anchoring stability of the artificial heart valve prosthesis in the patient's body.

[0070] Finally, it should be noted that the above embodiments and optional implementations in this specification are only used to illustrate the technical solutions of this application, and not to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing optional implementations, or equivalent substitutions can be made to some or all of the technical features. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application. In addition, it is emphasized again that, in the absence of conflict, the features of the embodiments and optional implementations in the embodiments in this specification can be combined with each other.

Claims

1. An artificial heart valve stent, characterized in that: Includes the main body of the support, the outflow section of the support, and the curved arm (200). The proximal end of the stent outflow section is integrally formed with the distal end of the stent body; The curved arm (200) is disposed on the support body and extends circumferentially along the support body. Along the circumferential direction of the support body, the curved arm (200) has a curved arm connecting end (210) and a curved arm free end (240). The curved arm connecting end (210) is fixedly connected to the support body or integrally formed, and the curved arm free end (240) is spaced apart from the support body.

2. The artificial heart valve stent according to claim 1, characterized in that: The artificial heart valve stent is an external stent (300), comprising an external stent body (310) and an external stent outflow section (320), wherein: The external stent (300) is a continuous circumferential closed structure. The curved arm (200) is located outside the external stent body (310). Its curved arm connecting end (210) is fixedly connected to or integrally formed with the external stent body (310). Its curved arm free end (240) is spaced apart from the external stent body (310) so that a semi-enclosed area for capturing the anterior leaf of the heart is formed between the curved arm (200) and the outer peripheral surface of the external stent body (310) for implantation.

3. The artificial heart valve stent according to claim 1, characterized in that: The artificial heart valve stent is an external stent (300), comprising an external stent body (310) and an external stent outflow section (320), wherein: The outer support (300) is a circumferentially non-fully enclosed structure with a fracture opening in the circumferential direction. The two free ends of the outer support body (310) in the circumferential direction are located on both sides of the fracture opening. The curved arm (200) is located at the fracture opening. Its curved arm connecting end (210) is fixedly connected to or integrally formed with one free end of the outer support body (310) in the circumferential direction. Its curved arm free end (240) is spaced apart from the other free end of the outer support body (310) in the circumferential direction.

4. The artificial heart valve stent according to claim 2 or 3, characterized in that: The outer support body (310) is provided with barbs (340) extending outward from the outer support body (310). The angle θ of the barbs (340) relative to the outer peripheral surface of the outer support body (310) satisfies: 0°≤θ≤40°; the length L2 of the barbs (340) satisfies: 2mm≤L2≤4mm. And / or, the outer support body (310) is provided with a barb (350) extending outward from the outer support body (310), and the minimum distance r between the proximal end of the barb (350) and the outer support body (310) in the radial direction along the outer support (300) satisfies: 0≤r≤4mm; the included angle Φ between the barb (350) and the outer peripheral surface of the outer support body (310) satisfies: -30°≤Φ≤30°.

5. The artificial heart valve stent according to claim 1, characterized in that: The artificial heart valve stent is an internal stent (100), which includes an internal stent inlet section (110), an internal stent body (120) and an internal stent outlet section (130) connected sequentially from the proximal end to the distal end. The internal stent inlet section (110) extends proximally and radially outward relative to the internal stent body (120). The curved arm (200) is located outside the inner stent body (120) and extends circumferentially along the inner stent body (120). Its curved arm connecting end (210) is fixedly connected to or integrally formed with the inner stent body (120). Its curved arm free end (240) is spaced apart from the inner stent body (120) so that a semi-enclosed area for capturing the anterior leaflet of the heart is formed between the curved arm (200) and the outer peripheral surface of the inner stent body (120) during implantation.

6. The artificial heart valve stent according to claim 5, characterized in that: The artificial heart valve stent also includes an artificial valve, which is fixedly connected inside the stent body (120). The inflow section (110) of the stent is D-shaped in its free state.

7. The artificial heart valve stent according to claim 5, characterized in that: Taking the axial direction of the stent (100) as the height direction, its proximal end as the upper end and its distal end as the lower end, and taking the part of the stent inlet segment (110) that matches the anterior leaf of the heart after implantation as the anterior part of the stent inlet segment (110), the part of the stent inlet segment (110) that matches the posterior leaf of the heart after implantation as the posterior part of the stent inlet segment (110), and the part of the stent inlet segment (110) located between the anterior part and the posterior part as the lateral part of the stent inlet segment (110), then: The height of the front part of the internal stent inflow section (110) is greater than the height of the rear part of the internal stent inflow section (110) and the height of the side part of the internal stent inflow section (110).

8. The artificial heart valve stent according to claim 1, characterized in that: Along the circumference of the main body of the support: the curved arm (200) is provided with a hollow part (201) extending circumferentially along the main body of the support. And / or, along the radial circular section of the support body: the portion of the bent arm (200) near its free end (240) is arc-shaped along the circumference of the support body, and along the circumference of the support body: the portion of the bent arm (200) near its free end (240) is wavy along the circumference of the support body. And / or, along the radial circular section of the support body, the end of the free end (240) of the bent arm is raised toward the side away from the support body to form a flange; And / or, both the bracket body and the curved arm connecting end (210) are provided with curved arm connecting holes, and the curved arm connecting end (210) is stitched or riveted to the bracket body through the curved arm connecting holes.

9. The artificial heart valve stent according to any one of claims 2 and 5-8, characterized in that: Along the radial circular cross section of the support body: the curved arm (200) includes a curved arm connecting end (210), a transition arc segment (220), a parallel arc segment (230), and a curved arm free end (240) connected in sequence; the parallel arc segment (230) is parallel to the outer peripheral surface of the support body; And / or, the curved arm (200) and the support body have a distance d in the direction along the radial direction of the support body, the distance d satisfying: 0≤d≤5mm.

10. An artificial heart valve prosthesis, characterized in that: The artificial heart valve prosthesis comprises an internal stent and the artificial heart valve stent as described in claim 2 or 3, or the artificial heart valve prosthesis comprises an external stent and the artificial heart valve stent as described in claim 5; wherein: There is a radial distance R between the outer support body (310) and the inner support body (120), and the radial distance R satisfies: 0≤R≤10mm; And / or, there is an axial distance L1 between the upper end of the outer support body (310) and the inner support inflow section (110), the axial distance L1 satisfying: 0≤L1≤5mm; And / or, the outer support body (310) is provided with a barb (350) extending outward from the outer support body (310), and the distance L3 between the proximal end of the barb (350) and the proximal end of the inner support inflow section (110) along the axial direction of the inner support (100) satisfies: 0≤L3≤9mm.

Images