Positioning member and valve stent

Abstract

Embodiments of the present application provide a positioning member and a valve support, and relate to the field of medical devices. The positioning member is suitable for the valve support, and at least part of the structure of the positioning member is elastic. The positioning member is used to connect the valve frame of the valve support. Since at least part of the structure of the positioning member is elastic, that is, the positioning member has self-buffering during insertion into the atrioventricular valve, and the risk of the positioning member being inserted into the atrioventricular valve is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically, to a positioning element and a valve stent. Background Technology

[0002] Aortic valve disease refers to a group of heart diseases caused by structural or functional abnormalities of the aortic valve, leading to obstruction or regurgitation of blood flow. Common aortic valve diseases include aortic stenosis and aortic regurgitation.

[0003] Transcatheter aortic valve replacement (TAVR) is a minimally invasive surgical procedure widely used internationally for the treatment of aortic valve disease. It involves using an interventional catheter to deliver an artificial heart valve to the aortic valve location, thus completing the implantation and restoring valve function. TAVR is a current trend in the treatment of aortic valve disease due to its minimal trauma, rapid recovery, and high postoperative quality of life for patients.

[0004] For regurgitation-type aortic valve disease, current TAVR products mostly use a stent (i.e., valve frame) with a positioning device. The positioning device is inserted into the valve sinus to position the valve, so that the valve leaflet position coincides with the original valve leaflet in the human body. This ensures better postoperative hemodynamics of the valve. At the same time, the clamping force of the positioning device and valve frame on the original valve leaflet ensures strong support after valve implantation, making it suitable for regurgitation-type aortic valve disease.

[0005] During TAVR surgery, the delivery system delivers the valve stent to the ascending main segment. The main body of the stent is compressed within the capsule cavity to await release. By controlling the forward movement and rotation of the delivery system, the three positioning elements of the valve are inserted into the valve sinuses. Then, the main body of the stent is released, allowing the positioning elements and the main body of the stent to clamp the valve leaflets. During the procedure of inserting the positioning device into the valve sinus using the delivery system, when the patient's ascending aortic and native aortic valves have complex anatomy, the axial and circumferential positions of the positioning device need to be continuously adjusted via the delivery system to ensure accurate valve implantation. Axial adjustment here can be understood as the positioning device advancing or retracting along the axial direction of the valve frame, while circumferential adjustment can be understood as rotating around the axis of the valve frame. During this process, the positioning device contacts the valve sinus and exerts a continuous force on it. The positioning device is often made of medical-grade metal. When the valve sinus is subjected to a large force from the positioning device, there is a risk that the metal skeleton of the positioning device may puncture the aortic valve sinus, leading to regurgitation after TAVR and surgical failure. Furthermore, under the impact of blood flow, the positioning device repeatedly impacts the valve sinus, increasing the impact force and further increasing the risk of puncturing the aortic valve sinus. Summary of the Invention

[0006] This invention provides a positioning element and a valve stent. The positioning element has a built-in buffer during the insertion of the valve sinus, which reduces the risk of the positioning element perforating the valve sinus.

[0007] The embodiments of the present invention can be implemented as follows:

[0008] In a first aspect, the present invention provides a positioning element suitable for valve stents, wherein at least a portion of the positioning element has an elastic structure, and the positioning element is used to connect the valve frame of the valve stent.

[0009] In an optional embodiment, the positioning element includes a first connecting section, a first clamping section, a guide section, a second clamping section, and a second connecting section connected in sequence. The guide section has a U-shaped structure. Both the first connecting section and the second connecting section are used to connect the valve frame of the valve stent.

[0010] Wherein, the connection between the first clamping section and the guide section is at an angle, so that the connection between the first clamping section and the guide section is used to approach the petal frame;

[0011] And / or, the connection between the second clamping segment and the guide segment is at an angle, so that the connection between the second clamping segment and the guide segment is used to approach the petiole.

[0012] In an optional implementation, a portion of the guide segment is an elastic element.

[0013] In an optional embodiment, the guide segment includes a first rod, an arc segment, and a second rod connected in sequence, wherein the first rod is connected to the first clamping segment, and the second rod is connected to the second clamping segment;

[0014] Wherein, the first rod and / or the second rod are elastic members.

[0015] In an optional embodiment, the radial outer contour dimension of the first rod is smaller than the radial outer contour dimension of the arc segment;

[0016] And / or, the radial outer contour dimension of the second rod is smaller than the radial outer contour dimension of the arc segment.

[0017] In an optional embodiment, the first rod is a spiral-shaped elastic member; or, the first rod is an elastic member that reciprocates along a straight line.

[0018] In an optional embodiment, the second rod is a helical elastic member; or, the second rod is an elastic member that reciprocates along a straight line.

[0019] In an optional embodiment, the positioning member has a U-shaped structure, and the middle part of the first clamping segment is bent away from the second clamping segment;

[0020] And / or, the middle portion of the second clamping segment bends away from the first clamping segment.

[0021] In an optional embodiment, the positioning element is made of an elastic material.

[0022] In a second aspect, the present invention provides a valve stent, including a valve frame and a positioning member as described in any of the foregoing embodiments, wherein the positioning member is connected to the valve frame.

[0023] The beneficial effects of the positioning element and valve stent of the present invention include, for example:

[0024] The present invention provides a positioning element suitable for valve stents. At least a portion of the positioning element is elastic. The positioning element is used to connect the valve frame of the valve stent. Because at least a portion of the positioning element is elastic, it provides a buffer during insertion into the valve sinus, reducing the risk of the positioning element perforating the valve sinus.

[0025] The present invention provides a valve stent, which includes a valve frame and the aforementioned positioning element, wherein the positioning element is connected to the valve frame, and the valve stent has all the functions of the aforementioned positioning element. Attached Figure Description

[0026] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of a valve stent provided in an embodiment of the present invention;

[0028] Figure 2 This is a front view of the positioning element provided in an embodiment of the present invention;

[0029] Figure 3 for Figure 2 Side view of the center positioning component;

[0030] Figure 4 for Figure 3 A schematic diagram showing the second clamping section and the guide section of the positioning component connected at an angle.

[0031] Figure 5 This is a front view of the positioning element provided in some embodiments of the present invention;

[0032] Figure 6 for Figure 5 Side view of the center positioning component;

[0033] Figure 7 This is a front view of the positioning element provided in some embodiments of the present invention;

[0034] Figure 8 for Figure 7 Side view of the center positioning component;

[0035] Figure 9 This is a schematic diagram of a positioning element provided in some embodiments of the present invention;

[0036] Figure 10 This is a front view of the positioning element provided in some embodiments of the present invention.

[0037] Icons: 100-Positioning component; 110-First connecting section; 120-First clamping section; 130-Guide section; 131-First rod; 132-Arc-shaped section; 133-Second rod; 140-Second clamping section; 150-Second connecting section; 101-Fixed connection point; 200-Petal frame. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0039] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0040] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0041] In the description of this invention, it should be noted that if terms such as "upper," "lower," "inner," or "outer" are used to 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 this invention is usually placed, they are only for the convenience of describing this invention 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, and therefore should not be construed as a limitation of this invention.

[0042] Furthermore, the terms "first" and "second" are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0043] It should be noted that, where there is no conflict, the features in the embodiments of the present invention can be combined with each other.

[0044] As mentioned in the background section, aortic valve disease refers to a group of heart diseases caused by structural or functional abnormalities of the aortic valve, resulting in obstruction or regurgitation of blood flow. Common aortic valve diseases include aortic stenosis and aortic regurgitation.

[0045] Transcatheter aortic valve replacement (TAVR) is a minimally invasive surgical procedure widely used internationally for the treatment of aortic valve disease. Through interventional catheter technology, an artificial heart valve is delivered to the location of the aortic valve, thereby completing the implantation of the artificial valve and restoring valve function. TAVR has become a current trend in the treatment of aortic valve disease due to its advantages such as minimal trauma, rapid recovery, and high postoperative quality of life for patients.

[0046] For regurgitation-type aortic valve disease, current TAVR products mostly use a stent (i.e., valve frame) with a positioning device. The positioning device is inserted into the valve sinus to position the valve, so that the valve leaflet position coincides with the original valve leaflet in the human body. This ensures better postoperative hemodynamics of the valve. At the same time, the clamping force of the positioning device and valve frame on the original valve leaflet ensures strong support after valve implantation, making it suitable for regurgitation-type aortic valve disease.

[0047] During TAVR surgery, the delivery system delivers the valve stent to the ascending main segment. The stent body is compressed within the capsule cavity awaiting release. By controlling the forward movement and rotation of the delivery system, the three positioning elements of the valve are inserted into the valve sinuses. Then, the valve stent body is released, allowing the positioning elements and the stent body to clamp the valve leaflets. This process involves the delivery system inserting the positioning elements into the valve sinuses.

[0048] When the patient's ascending aortic and native aortic valves have complex anatomical morphology, in order to ensure the accuracy of valve implantation, it is necessary to continuously adjust the axial and circumferential positions of the positioning device through the delivery system during the operation. Here, axial adjustment can be understood as the positioning device moving forward or backward along the axial direction of the valve frame, and circumferential adjustment can be understood as rotating around the axis of the valve frame.

[0049] During this process, the positioning device comes into contact with the aortic sinus and exerts a continuous force on it. The positioning device is often made of medical-grade metal. When the aortic sinus is subjected to a large force from the positioning device, the metal skeleton of the positioning device may puncture the aortic sinus, leading to regurgitation in patients after TAVR and surgical failure. Furthermore, under the impact of blood flow, the positioning device may repeatedly impact the aortic sinus, increasing the impact force and further increasing the risk of puncturing the aortic sinus.

[0050] In view of this, please refer to Figures 1-10 The positioning element 100 and valve stent provided in the embodiments of the present invention can solve this problem, and will be described in detail below.

[0051] Please refer to this first. Figure 1 This invention provides a valve stent comprising a valve frame 200 and a positioning member 100 connected to the valve frame 200. Specifically, the positioning member 100 is adapted to the valve stent, and at least a portion of its structure is elastic. The positioning member 100 is used to connect to the valve frame 200 of the valve stent. Because at least a portion of the positioning member 100 is elastic, it provides cushioning during insertion into the valve sinus, preventing the positioning member 100 from being subjected to excessive force and reducing the risk of perforation of the valve sinus. In this embodiment, the positioning member 100 has a U-shaped structure and includes a first connecting segment 110, a first clamping segment 120, a guide segment 130, a second clamping segment 140, and a second connecting segment 150 connected in sequence. The guide segment 130 has a U-shaped structure. Both the first connecting segment 110 and the second connecting segment 150 are used to connect to the valve frame 200 of the valve stent.

[0052] It should be noted that, in this embodiment, the positioning element 100 and the petal frame 200 can be designed as a single piece, for example, by cutting and heat-setting nickel-titanium tubing. The height of the positioning element 100 is 0.5-1 times the height of the petal frame 200. Here, the height of the petal frame 200 can be understood as the maximum length of the petal frame 200 along the axis of the petal frame 200.

[0053] It should be noted that the positioning member 100 needs to clamp the petal, so the positioning member 100 itself has a certain elasticity. When the positioning member 100 is subjected to hard force without buffering, the force will also act directly on the connection between the positioning member 100 and the petal frame 200, thereby causing the connection between the positioning member 100 and the petal frame 200 (i.e. the connection between the first connecting segment 110 and the petal frame 200 and the connection between the second connecting segment 150 and the petal frame 200) to break.

[0054] It should be noted that the aforementioned positioning element 100 itself is elastic, meaning that the connection between the positioning element 100 and the petal frame 200 can be folded up and down along the connection, and has resilience, so as to clamp the petal. Therefore, the positioning element 100 itself cannot buffer axial and circumferential forces.

[0055] Please continue to refer to this. Figures 2-4The first clamping section 120 and the guide section 130 are connected at an angle so that the connection between the first clamping section 120 and the guide section 130 is used to approach the valve frame 200, and / or the second clamping section 140 and the guide section 130 are connected at an angle so that the connection between the second clamping section 140 and the guide section 130 is used to approach the valve frame 200.

[0056] In this embodiment, the connection between the first clamping section 120 and the guide section 130 is at an angle, for example, 110°, so that the connection between the first clamping section 120 and the guide section 130 is used to approach the valve frame 200. At the same time, the connection between the second clamping section 140 and the guide section 130 is at an angle, for example, 110°, so that the connection between the second clamping section 140 and the guide section 130 is used to approach the valve frame 200.

[0057] Of course, in some embodiments, the connection between the first clamping segment 120 and the guide segment 130 may be at an angle, or the connection between the second clamping segment 140 and the guide segment 130 may be at an angle.

[0058] The connection between the first clamping section 120 and the guide section 130, as well as the connection between the second clamping section 140 and the guide section 130, can be used to press down on the leaflets to achieve the function of clamping the leaflets.

[0059] In this way, the bending at the connection between the first clamping segment 120 and the guide segment 130, and at the connection between the second clamping segment 140 and the guide segment 130, provides a certain degree of elastic deformation, which acts as a buffer when inserted into the valve sinus, reducing the risk of perforation of the valve sinus.

[0060] It should be noted here that, since the guide section 130 has a U-shaped structure, the guide section 130 consists of two straight sections and one arc section. The two straight sections are respectively connected to the two ends of the two arc sections. The angle between one of the straight sections and the center of the valve frame 200 is α, and the angle α can be in the range of 0-50°. The angle between the other straight section and the center of the valve frame 200 can also be in the range of 0-50°.

[0061] The center of the valve frame 200 can be understood as the central plane of the valve frame 200, which includes the axis of the valve frame 200, or is parallel to the axis of the valve frame 200.

[0062] The angle between the center of the first clamping section 120 and the center of the petiole frame 200 is β, and the angle β can be in the range of 0-60°. The angle between the center of the second clamping section 140 and the center of the petiole frame 200 can also be in the range of 0-60°. Wherein, d is the shortest distance between the first clamping section 120, the second clamping section 140, or the guide section 130 of the positioning member 100 and the petiole frame 200.

[0063] When the positioning element 100 is ready to enter the valvular sinus to capture the leaflet, there is a larger space between the guide section 130 of the positioning element 100 and the valve frame 200. That is, the side of the positioning element 100 away from the port of the valve frame 200 is tilted away from the valve frame 200 to facilitate the capture of the leaflet.

[0064] Please continue to refer to this. Figures 5-6 To further enhance the buffering effect of the positioning member 100, part of the structure of the guide section 130 is an elastic member. Specifically, the guide section 130 includes a first rod 131, an arc-shaped section 132, and a second rod 133 connected in sequence. The first rod 131 is connected to the first clamping section 120, and the second rod 133 is connected to the second clamping section 140. The first rod 131 and / or the second rod 133 are elastic members.

[0065] For example, in this embodiment, the first member 131 and the second member 133 are elastic members. In some embodiments, either the first member 131 or the second member 133 may also be an elastic member.

[0066] Specifically, in this embodiment, the radial outer contour dimension of the first member 131 is smaller than the radial outer contour dimension of the arc segment 132, and at the same time, the radial outer contour dimension of the second member 133 is smaller than the radial outer contour dimension of the arc segment 132.

[0067] Here, the radial outer contour dimension of the first member 131 can be understood as the outer contour of the cross section of the first member 131 in the axial extension direction, the radial outer contour dimension of the second member 133 can be understood as the outer contour of the cross section of the second member 133 in the axial extension direction, and the radial outer contour dimension of the arc segment 132 can also be understood as the outer contour of the cross section of the arc segment 132 in the axial extension direction.

[0068] In other words, the first rod 131 and the second rod 133 of the guide section 130 are equivalent to a variable diameter section with a reduced outer diameter, and the first rod 131 and the second rod 133 can be integrally formed with the arc section 132.

[0069] Alternatively, the first rod 131 and the second rod 133 can be separate components connected to the arc segment 132. In this case, the first rod 131 and the second rod 133 can be made of medical stainless steel and connected to the arc segment 132, the first clamping segment 120 and the second clamping segment 140 by welding.

[0070] It should be noted that the first rod 131 and the second rod 133 can be understood as the variable diameter section with a reduced outer diameter on the entire positioning member 100. The rest of the positioning member 100 structure can be understood as the main body of the positioning member 100, which includes the arc-shaped section 132, the first connecting section 110, the first clamping section 120, the second clamping section 140 and the second connecting section 150. The outer diameter of the main body of the positioning member 100 is greater than the outer diameter of the first rod 131 and the second rod 133. That is to say, the elastic modulus of the variable diameter section is less than the elastic modulus of the main body of the positioning member 100.

[0071] Therefore, when the positioning element 100 is subjected to the reaction force of the valve sinus, the variable diameter section is more likely to bend, which can provide a better buffering effect.

[0072] Of course, in some embodiments, the radial outer contour dimension of the first member 131 may be smaller than the radial outer contour dimension of the arc segment 132, or the radial outer contour dimension of the second member 133 may be smaller than the radial outer contour dimension of the arc segment 132.

[0073] Please continue to refer to this. Figure 7 and Figure 8 In some embodiments, the first rod 131 of the positioning member 100 may also be a spiral elastic member, such as a spiral spring wire, or the first rod 131 may be an elastic member that bends back and forth along a straight line, such as an elastic wire that bends back and forth along a straight line. In this case, the first rod 131 must maintain rigidity, that is, it needs to have clamping force on the leaflet, and at the same time it needs to have a certain degree of flexibility so as not to puncture the sinus.

[0074] Of course, the second rod 133 can also be a spiral elastic element, such as a spiral spring wire; or, the second rod 133 can be an elastic element that bends back and forth along a straight line, such as an elastic wire that bends back and forth along a straight line. It is easy to understand that the second rod 133 must maintain rigidity, that is, it needs to have clamping force on the leaflet, and at the same time, it also needs a certain degree of flexibility so as not to puncture the sinus.

[0075] The first rod 131, the second rod 133 and the positioning part 100 are integrally formed, for example by integral cutting, such as cutting nickel-titanium alloy, or integral weaving, such as weaving stainless steel wire or nickel-titanium wire.

[0076] Of course, such as Figure 9As shown, the first rod 131 and the second rod 133 can also be separate components, such as stainless steel wire or nickel-titanium wire. They can be connected at the fixed connection point 101 by welding, sewing, riveting, etc. The first rod 131 and the second rod 133 can be woven from a single strand of stainless steel wire or nickel-titanium wire, or they can be woven from multiple strands of nickel-titanium wire.

[0077] Please refer to Figure 10 In order to improve the clamping firmness of the positioning member 100 on the leaflet, in some embodiments, the middle part of the first clamping section 120 is bent away from the second clamping section 140, and / or the middle part of the second clamping section 140 is bent away from the first clamping section 120.

[0078] In this embodiment, the middle portion of the first clamping segment 120 bends away from the second clamping segment 140, while the middle portion of the second clamping segment 140 bends away from the first clamping segment 120, relative to... Figure 1 For the positioning element 100, this increases the area surrounding the inner side of the entire positioning element 100, increases the clamping area between the positioning element 100 and the leaflet, and improves the anti-displacement ability of the valve stent.

[0079] Of course, in some embodiments, the middle portion of the first clamping segment 120 may be bent away from the second clamping segment 140, or the middle portion of the second clamping segment 140 may be bent away from the first clamping segment 120.

[0080] Please refer to this again. Figure 7 It should be noted that when the first rod 131 and the second rod 133 are deformed, the middle part of the first rod 131 can bend away from the second rod 133, and at the same time, the middle part of the second rod 133 can bend away from the first rod 131, or the entire inner side of the positioning member 100 can be surrounded to create an area, thereby improving the stability of the leaf clamping.

[0081] Of course, in some embodiments, the entire structure of the positioning member 100 is made of elastic material, which refers to nickel-titanium alloy wire. Nickel-iron alloy wire itself also has a certain rigidity, which is required to clamp the leaflets. Therefore, while ensuring a certain rigidity of the positioning member 100, it can provide better cushioning.

[0082] In addition, it should be noted that in order to reduce the friction between the positioning element 100 and the valve sinus or leaflet, the surface of the positioning element 100 is provided with a friction-reducing layer. That is, a film can be applied to the surface of the positioning element 100. The film material can be a medical polymer material, such as PTFE (polytetrafluoroethylene) or PET (polyethylene terephthalate).

[0083] In summary, the positioning element 100 is suitable for valve stents. At least part of the structure of the positioning element 100 is elastic. The positioning element 100 is used to connect the valve frame 200 of the valve stent. Since at least part of the structure of the positioning element 100 is elastic, that is, the positioning element 100 has its own buffer during the insertion of the valve sinus, reducing the risk of the positioning element 100 perforating the valve sinus.

[0084] The present invention provides a valve stent, which includes a valve frame 200 and the aforementioned positioning element 100. The positioning element 100 and the valve frame 200 are connected. The valve stent has all the functions of the aforementioned positioning element 100 and has significant clinical application value.

[0085] The positioning component 100 itself has been improved so as not to increase the overall size of the valve stent, thus avoiding affecting the subsequent assembly of the valve stent in the delivery system. At the same time, it can improve vascular applicability.

[0086] The positioning element 100 has an elastic design (e.g., bending at the connection between the first clamping section 120 and the guide section 130, and at the connection between the second clamping section 140 and the guide section 130) to ensure good capture of the valve leaflets while providing a certain buffering effect when inserted into the valve sinus. The positioning element 100 has a variable stiffness design (e.g., the positioning element 100 has a variable diameter section) to provide better buffering when inserted into the valve sinus and improve the fault tolerance of the operation. At the same time, the positioning element 100 has a fully elastic design to provide better buffering while ensuring a certain stiffness of the positioning element 100.

[0087] In addition, the middle part of the first clamping section 120 bends away from the second clamping section 140, and the middle part of the second clamping section 140 bends away from the first clamping section 120. In this way, the inner area of ​​the entire positioning member 100 is increased, the clamping area between the positioning member 100 and the leaflet is increased, and the anti-displacement ability of the valve stent is improved.

[0088] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A positioning element suitable for valve stents, characterized in that, The positioning member has at least a portion of its structure being elastic, and the positioning member is used to connect the valve frame (200) of the valve stent; the positioning member includes a first connecting section (110), a first clamping section (120), a guide section (130), a second clamping section (140), and a second connecting section (150) connected in sequence, the guide section (130) having a U-shaped structure, and both the first connecting section (110) and the second connecting section (150) being used to connect the valve frame (200) of the valve stent. The connection between the first clamping section (120) and the guide section (130) is at an angle, so that the connection between the first clamping section (120) and the guide section (130) is used to approach the petiole frame (200). And / or, the connection between the second clamping segment (140) and the guide segment (130) is at an angle, so that the connection between the second clamping segment (140) and the guide segment (130) is used to approach the petiole frame (200). Part of the structure of the guide section (130) is an elastic element; The guide section (130) includes a first rod (131), an arc section (132) and a second rod (133) connected in sequence. The first rod (131) is connected to the first clamping section (120), and the second rod (133) is connected to the second clamping section (140). Wherein, the first rod (131) and / or the second rod (133) are elastic members; The first rod (131) is a spiral elastic member; or, the first rod (131) is an elastic member that bends back and forth along a straight line. The second rod (133) is a spiral elastic member; or, the second rod (133) is an elastic member that bends back and forth along a straight line. The positioning member has a U-shaped structure, and the middle part of the first clamping section (120) is bent away from the second clamping section (140); And / or, the middle portion of the second clamping segment (140) bends away from the first clamping segment (120).

2. The positioning element according to claim 1, characterized in that, The radial outer contour dimension of the first rod (131) is smaller than the radial outer contour dimension of the arc segment (132); And / or, the radial outer contour dimension of the second rod (133) is smaller than the radial outer contour dimension of the arc segment (132).

3. The positioning element according to claim 1, characterized in that, The positioning element is made of an elastic material.

4. A valve stent, characterized in that, It includes a petiole frame (200) and a positioning element as described in any one of claims 1-3, wherein the positioning element is connected to the petiole frame (200).

Images