Artificial valve stent, artificial valve structure, and release method

Abstract

The present invention provides an artificial valve stent (100), an artificial valve structure, and a release method, which belong to the medical technology field. The artificial valve stent (100) includes a first stent (10) and a second stent (20), the first stent (10) including a first stent body (11) and a first positioning portion (12) for positioning on the first side (21) of the cardiac valve annulus, the first stent body (11) having a defined flow path (30) for blood flow, and the first positioning portion (12) extending radially outward from the first stent body (11), the second stent (20) includes a connecting portion (21) located radially outside the first stent body (11) and connecting to the first stent body (11), and a second positioning portion (22) for positioning on the second side (202) of the cardiac valve annulus. Such mitral valve stents can reduce the difficulty of releasing the artificial valve structure and improve the ease of the release procedure.

Description

Technical Field

[0001] This application belongs to the technical field of medicine, and specifically relates to an artificial valve stent, an artificial valve structure, and a release method.

[0002] (Cross-reference to related applications) This application claims priority based on a Chinese application filed with the Chinese Patent Office on October 13, 2023, with an application number of 202311331926.4 and a title of "Artificial Valve Stent, Artificial Valve Structure, and Release Method", and all of its content is incorporated herein by reference in its entirety.

Background Art

[0003] Mitral valve stenosis or regurgitation is one of the common valvular heart diseases. The mitral valve has a congenital abnormality or acquired lesion and cannot completely close during the contraction of the left ventricle. As a result, a part of the blood flowing from the left atrium into the left ventricle flows back into the left atrium, causing a series of pathological changes and clinical symptoms of the heart. In severe cases, it can cause heart failure and even death. Mitral valve replacement is to implant an artificial valve to replace the self-mitral valve that has lost its function due to the lesion, so as to improve mitral valve regurgitation, relieve or reconstruct the clinical symptoms caused by mitral valve stenosis.

[0004] Many of the conventional mitral valve replacement stents are cylindrical. After anchor fixation, they are supported by using the radial supporting force of the elasticity of the stent itself. And as the structure of the conventional valve stent, many are single-layer stents. Of course, there are also two-layer stents. For example, in the patent with a publication number of CN108578016B, a mitral valve device for a transapical approach is disclosed, and the stent of the mitral valve device is a two-layer stent. However, both of the two anchor fixation points of the stent are located on the outer-layer valve stent, and the artificial mitral valve is anchor-fixed in the body through the outer-layer valve stent. When releasing the artificial mitral valve, in order to realize the release of the artificial mitral valve, it must be accurately positioned at the target position, and the difficulty of positioning is relatively high.

Summary of the Invention

[0005] The embodiments of this application provide an artificial valve stent, an artificial valve structure, and a release method that can reduce the difficulty of releasing the artificial valve structure and improve the ease of the release operation.

[0006] Embodiments of this application provide an artificial valve. The artificial valve stent includes a first stent and a second stent, the first stent including a first stent body and a first positioning portion for positioning on the first side of the cardiac valve annulus, the first stent body having a defined flow path for blood to flow through, and the first positioning portion extending radially outward from the first stent body, the second stent including a connecting portion located radially outward from the first stent body and connecting to the first stent body, and a second positioning portion for positioning on the second side of the cardiac valve annulus.

[0007] In this embodiment, the artificial valve stent employs a two-layer stent structure, and the positioning structure of the artificial valve stent is designed to be a separate component. The first stent and the second stent are each equipped with a first positioning section and a second positioning section. In this way, when releasing the artificial valve structure, the second stent is released first. At this time, the first stent has not yet been completely released, so the position of the second stent is adjusted according to the actual situation to position the second positioning section of the second stent on the second side of the cardiac valve annulus, after which the first stent is released, thereby achieving the release of the artificial valve stent. In this way, before releasing the second stent, it is not necessary to precisely position the sheath after it has entered the target position, as in conventional techniques, before releasing the valve stent. Instead, the second stent can be released into the ventricular region on the second side of the cardiac valve annulus. After releasing the second stent, the position of the sheath can be finely adjusted so that the second positioning part of the second stent is positioned on the second side of the cardiac valve annulus, and then the first stent can be released directly. Furthermore, it is possible to ensure that the first and second positioning parts are precisely positioned on the first and second sides of the cardiac valve annulus, respectively. This reduces the difficulty of positioning for the release of the artificial valve structure and improves the ease of the release operation.

[0008] In some embodiments, the first stent is provided with a first connection hole, and the connection portion is provided with a second connection hole, and the artificial valve stent further includes a connecting member for connecting the first stent and the second stent, the connecting member being inserted into the first connection hole and the second connection hole.

[0009] In the above embodiment, the first stent is provided with a first connection hole, and the connection portion is provided with a second connection hole. By connecting the stents by passing the connecting member through the first and second connection holes, the first and second stents can be processed individually during production. This reduces the difficulty of processing the artificial valve stents, and when assembling, the first and second stents can be connected using the connecting member, making the operation simple.

[0010] In some embodiments, when the upstream and downstream directions are defined along the direction of blood flow in the blood passage, the first positioning unit is installed at the upstream end of the first stent body.

[0011] In some embodiments, the first positioning section includes a plurality of first positioning units, which are arranged circumferentially, each of which includes two first positioning rod-shaped structures, and the two first positioning rod-shaped structures of the same first positioning unit are connected at their ends spaced apart from the flow path to form a first positioning point, the first positioning points of the plurality of first positioning units are spaced apart along the circumferential direction, and the two first positioning rod-shaped structures belonging to two adjacent first positioning units are connected such that they form a first connection point at the end closest to the flow path.

[0012] In the above embodiment, by installing multiple first positioning units along the circumferential direction, the multiple first positioning units can cooperate to achieve circumferential positioning relative to the first side of the cardiac valve annulus. Each first positioning unit includes two first positioning rod-shaped structures, and the ends of the two first positioning rod-shaped structures, spaced apart from the flow path, are connected to form a first positioning point. Multiple positions relative to the first side of the cardiac valve annulus are achieved by utilizing the first positioning point in each first positioning unit, resulting in a simple structure and high positioning stability.

[0013] In some embodiments, the first positioning unit further includes a plurality of second positioning units, with one second positioning unit installed between two adjacent first positioning units, each second positioning unit including two second positioning rod-shaped structures, the two second positioning rod-shaped structures having their ends spaced apart from the flow path connected to form a second positioning point, the first and second positioning points being alternately installed along the circumferential direction, and the ends of the second positioning rod-shaped structures close to the flow path connected to the first positioning rod-shaped structures.

[0014] In the above embodiment, a second positioning unit is installed between two adjacent first positioning units, and the ends of the two second positioning rod-shaped structures in the second positioning unit are connected at the ends spaced apart from the flow path to form a second positioning point. Furthermore, the first and second positioning points are alternately installed along the circumferential direction, thereby increasing the number of positioning points on the first side of the heart valve annulus in the circumferential direction of the first positioning unit, making the positioning points on the first side of the heart valve annulus of the first positioning unit more densely packed, reducing the force received by each positioning point, and further improving the integration of the first positioning unit by having the second positioning unit lean against the first positioning unit and connecting the two as a single unit, thereby improving the stability of the first positioning unit.

[0015] In some embodiments, the first positioning unit further includes a plurality of third positioning units, the plurality of third positioning units arranged circumferentially, each third positioning unit includes two third positioning rod-shaped structures, the two third positioning rod-shaped structures of the same third positioning unit are connected at their ends spaced away from the flow path to form a third positioning point, the third positioning points of the plurality of third positioning units are spaced apart circumferentially, the first positioning point protrudes further than the third positioning point in the direction away from the flow path, and the two third positioning rod-shaped structures belonging to two adjacent third positioning units are connected such that they form a first connection point at their ends close to the flow path.

[0016] In the above embodiment, the first positioning section further includes a plurality of third positioning units, each third positioning unit including two third positioning rod-shaped structures, the ends of which are spaced apart from the flow path are connected to form a third positioning point, thereby increasing the number of positioning points of the first positioning section relative to the first side of the heart valve annulus. The first positioning point protrudes further than the third positioning point in the direction away from the flow path, that is, the third positioning is located inside the first positioning point, thereby enabling the first positioning section to position the first side of the heart valve annulus at multiple points in the radial direction, thereby improving the stability of the first positioning section's positioning relative to the first side of the heart valve annulus. The two third positioning rod-shaped structures belonging to two adjacent third positioning units are connected such that they form a first connection point at the end close to the flow path, thereby connecting the first positioning unit and the third positioning unit as a single unit, improving the integrity of the first positioning section.

[0017] In some embodiments, the first stent body includes a plurality of support units, which are arranged circumferentially to define and form a flow path, each of which includes a first support rod structure and a second support rod structure, and in the same support unit, the upstream end of the first support rod structure and the upstream end of the second support rod structure are connected to two first connection points, respectively, and the downstream end of the first support rod structure and the downstream end of the second support rod structure are connected to form a second connection point.

[0018] In the above embodiment, in multiple support units, the upstream end of the first support rod-shaped structure and the upstream end of the second support rod-shaped structure are connected to two first connection points, thereby connecting the multiple support units and the first positioning unit as a single unit.

[0019] In some embodiments, a first connection hole is provided at the second connection point for connecting to a second stent.

[0020] In the above embodiment, the second connection point is located at the downstream end of the first support rod structure and the downstream end of the second support rod structure, and the second connection point is provided with a first connection hole for connecting to the second stent. As a result, the second stent is connected to the downstream end of the first stent, which helps to ensure that after the second stent is released, only the downstream end portion of the first stent is inflated by the second stent, and that after the second stent is completely released, the upstream end of the first stent remains inside the sheath.

[0021] In some embodiments, the number of first positioning units is twice the number of support units, and within the same support unit, the upstream end of the first support rod structure and the upstream end of the second support rod structure are connected to two alternate first connection points, respectively.

[0022] In some embodiments, each support unit further includes a third support rod structure and a fourth support rod structure, the third support rod structure having one end connected to a first connection point located between the first support rod structure and the second support rod structure, and the other end connected to the intermediate portion of the first support rod structure, and the fourth support rod structure having one end connected to a first connection point located between the first support rod structure and the second support rod structure, and the other end connected to the intermediate portion of the second support rod structure.

[0023] In the above embodiment, a third support rod structure and a second support rod structure are installed, and one end of the third support rod structure is connected to a first connection point located between the first support rod structure and the second support rod structure. As a result, all first connection points in the first positioning unit are connected to be supported in accordance with the support unit, preventing the phenomenon of unconnected first connection points and ensuring the overall stability of the first stent.

[0024] In some embodiments, the connecting portion is located radially outward of the first stent body, the second positioning portion extends radially outward from the connecting portion and is located upstream of the connecting portion, the second positioning portion includes a plurality of fourth positioning units, and the plurality of fourth positioning units are installed along the circumferential direction.

[0025] In the above embodiment, the second positioning section includes a plurality of fourth positioning units, and the plurality of fourth positioning units distributed in the circumferential direction are positioned on the second side of the cardiac valve annulus, thereby enabling positioning at multiple locations, preventing the occurrence of weak points in positioning in the circumferential direction of the second stent, and ensuring the stability of the positioning of the second stent.

[0026] In some embodiments, each fourth positioning unit includes two fourth positioning rod-shaped structures. The two fourth positioning rod-shaped structures of the same fourth positioning unit are connected at their ends spaced apart from the flow path to form a fourth positioning point. The fourth positioning points of the plurality of fourth positioning units are arranged at intervals along the circumferential direction. The two fourth positioning rod-shaped structures respectively belonging to two adjacent fourth positioning units are connected to form a third connection point at their ends close to the flow path.

[0027] In the above embodiments, each fourth positioning unit includes two fourth positioning rod-shaped structures. The two fourth positioning rod-shaped structures are connected at their ends spaced apart from the flow path to form a fourth positioning point. By using the fourth positioning points in each fourth positioning unit, positioning by a plurality of points on the second side of the heart valve annulus is realized. The fourth positioning unit has a simple structure and high positioning stability.

[0028] In some embodiments, the second positioning portion further includes a plurality of fifth positioning units. The plurality of fifth positioning units are installed along the circumferential direction. The fifth positioning units are located downstream of the fourth positioning units. Each of the fifth positioning units includes two fifth positioning rod-shaped structures. The two fifth positioning rod-shaped structures of the same fifth positioning unit are connected at their ends spaced apart from the flow path to form a fifth positioning point. The fifth positioning points of the plurality of fifth positioning units are arranged at intervals along the circumferential direction. The two fifth positioning rod-shaped structures respectively belonging to two adjacent fifth positioning units are connected to form a fourth connection point at their ends close to the flow path.

[0029] In the above embodiments, the second positioning portion further includes a plurality of fifth positioning units distributed in the circumferential direction, and the fifth positioning units are located downstream of the fourth positioning units. The two fifth positioning rod-shaped structures in the fifth positioning unit are connected at their ends spaced apart from the flow path to form a fifth positioning point. Thereby, the second stent is positioned by a plurality of points in the extending direction of the flow path, and the positioning effect and stability between the second stent and the second side of the heart valve annulus are improved.

[0030] In some embodiments, the connection part includes a plurality of fifth support rod-shaped structures, the plurality of fifth support rod-shaped structures are arranged at intervals along the circumferential direction, and each fifth support rod-shaped structure has one end connected to the third connection point and the other end connected to the fourth connection point.

[0031] In the above embodiments, the fourth positioning unit and the fifth positioning unit are integrally connected via the fifth support rod-shaped structure, so that the second positioning part and the connection part are integrally connected, ensuring the integrity of the second stent.

[0032] In some embodiments, a second connection hole for connecting to the first stent is provided at the fourth connection point.

[0033] In the above embodiments, since the fourth connection point is located at the downstream end of the fifth support rod-shaped structure and a second connection hole for connecting to the first stent is provided at the fourth connection point, the downstream end of the second stent and the downstream end of the first stent are connected. After the second stent is released, the second stent can be completely released. By releasing the second stent, only the downstream end portion of the first stent is inflated, and after the second stent is completely released, it can contribute to ensuring that the upstream end of the first stent still remains within the sheath.

[0034] In some embodiments, the number of the first positioning units is six, and the six first positioning units are evenly distributed in the circumferential direction.

[0035] The embodiments of the present application further provide an artificial valve structure. The artificial valve structure includes a valve and an artificial valve stent, and the valve is located in the flow path of the first stent body.

[0036] In some embodiments, the artificial valve structure includes a cover member, the cover member is installed outside the second stent and / or the first stent, and the inside of the cover member extends to the valve.

[0037] In the above embodiment, a cover member is installed on the outside of the second stent, and the inside of the cover member extends to the valve, thereby covering and shielding the outside of the second stent and / or the first stent, preventing blood from flowing back from the second side of the cardiac valve annulus to the first side of the cardiac valve annulus, and ensuring that blood flows only from the first side of the cardiac valve annulus to the second side of the cardiac valve annulus.

[0038] Embodiments of this application further provide a method for releasing an artificial valve structure. The release method includes the steps of releasing a second stent of the artificial valve structure, extending the second stent radially, and adjusting the second stent until the second positioning portion is positioned on the second side of the target annular object; and releasing a first stent of the artificial valve structure and positioning the first positioning portion of the first stent on the first side of the target annular object.

[0039] This artificial valve stent allows the second stent to self-inflate if the first stent is not yet fully released, and the second stent does not become completely tightly attached to the second side of the target annular structure. Instead, after the second stent is released, the position of the artificial valve stent can be adjusted even if the upstream end of the first stent is not yet released. Since the position of the second stent can be finely adjusted even after it has been released, a certain degree of error in the tightness of the second stent to the second side of the target annular structure is acceptable, reducing the difficulty of positioning the release of the artificial valve structure and improving the ease of the release operation. After adjusting the position of the sheath, the first stent can be directly released with the second positioning portion of the already released second stent positioned on the second side of the cardiac valve annulus. This ensures that the first and second positioning portions are precisely positioned on the first and second sides of the target annular structure, enabling precise release of the artificial valve stent, reducing the difficulty of the surgery, and lowering the risk of surgery.

[0040] In some embodiments, adjusting the second stent involves adjusting the angle of the second stent relative to the target annular object, and positioning the second positioning section on the second side of the target annular object involves pulling the second stent so that the second positioning section is close to the target annular object. In this way, when adjusting the position of the second stent, not only the angle of the second stent relative to the target annular object but also the distance between the second stent and the target annular object can be adjusted, thereby achieving precise positioning of the second stent and the target annular object.

[0041] Other features and advantages of this application will be described in detail in the embodiments for carrying out the invention described below. [Brief explanation of the drawing]

[0042] To more clearly explain the technical concept of the embodiments of this application, the drawings used in the embodiments are briefly described below. The drawings described are merely examples of some embodiments of this application and do not limit their scope. Those skilled in the art can obtain other relevant drawings based on these drawings without employing inventive ability. [Figure 1] This is a schematic diagram illustrating the configuration of an artificial valve stent positioned on the cardiac valve annulus according to some embodiments of this application. [Figure 2] This is a schematic diagram of an artificial valve stent according to several embodiments of this application. [Figure 3] This is a schematic diagram of an artificial valve stent from a different angle, according to some embodiments of this application. [Figure 4] Figure 3 is a plan view of the artificial valve stent. [Figure 5] This is a plan view of a first stent according to several embodiments of this application. [Figure 6] This is a front view of a first stent according to some embodiments of this application. [Figure 7] This is a schematic diagram of the second stent according to some embodiments of the present application. [Figure 8]Figure 7 is a front view of the second stent. [Figure 9] These are schematic diagrams of artificial valve structures according to several embodiments of this application, prior to their release. [Figure 10] This is a schematic diagram of the artificial valve structure after the second stent has been released, according to some embodiments of this application. [Figure 11] Figure 10 is a schematic diagram showing the state after the sheath position has been adjusted and the second stent has been positioned on the cardiac valve annulus. [Figure 12] This is a schematic diagram showing the completed release state of an artificial valve structure according to several embodiments of this application. [Figure 13] This schematic diagram shows how to fine-tune the angle of an artificial valve structure according to some embodiments of this application before release. [Figure 14] This is a schematic diagram illustrating the fine-tuning of the second stent of an artificial valve structure according to some embodiments of this application after it has been released. [Modes for carrying out the invention]

[0043] To clarify the purpose, technical proposal, and advantages of the embodiments of this application, the technical proposal in the embodiments of this application will be clearly and completely described below with reference to the drawings used in the embodiments of this application. The embodiments described are only a selection of embodiments of this application, not all embodiments. The components in the embodiments of this application shown herein with reference to the drawings can be arranged and designed in various ways.

[0044] Therefore, the following detailed description of the embodiments of this application shown in the drawings is merely to illustrate selected embodiments of this application and does not limit the scope of the application to be protected. Based on the embodiments of this application, all other embodiments that a person skilled in the art could obtain without using their inventive ability also fall within the scope of protection of this application.

[0045] Similar symbols indicate the same thing in drawings; therefore, if defined in one drawing, it is unnecessary to define or interpret them further in other drawings.

[0046] In the description of the embodiments of this application, the directions or positional relationships shown are based on the drawings or are typical arrangement directions or positional relationships of the products relating to the application, and are merely for the purpose of briefly and concisely describing this application. They do not necessarily express or imply that the device or element has a particular direction or is configured or operated in a particular direction, and therefore do not limit this application. Furthermore, terms such as "first," "second," and "third" are merely for illustrative purposes and do not express or imply relative importance.

[0047] In the description of this application, unless otherwise specified, the terms “installation” and “connection” should be understood in a broad sense. For example, it may be a fixed connection, a removable connection, or an integral connection. It may be a direct connection, an indirect connection via an intermediate object, or the interiors of the two elements may be in communication. A person skilled in the art will be able to understand the specific meaning of the above terms in this application depending on the specific circumstances.

[0048] Examples Embodiments of this application provide an artificial valve. Referring to Figures 1 to 14, the artificial valve stent 100 includes a first stent 10 and a second stent 20. The first stent 10 includes a first stent body 11 and a first positioning portion 12 for positioning on the first side 201 of the cardiac valve annulus, the first stent body 11 having a defined flow path 30 for blood flow, and the first positioning portion 12 extending radially outward from the first stent body 11. The second stent 20 includes a connecting portion 21 located radially outside the first stent body 11 and connected to the first stent body 11, and a second positioning portion 22 for positioning on the second side 202 of the cardiac valve annulus.

[0049] In this embodiment, the artificial valve stent 100 employs a two-layer stent structure, and the positioning structure of the artificial valve stent 100 is designed to be a separate component. The first stent 10 and the second stent 20 are equipped with a first positioning section 12 and a second positioning section 22, respectively. In this way, when releasing the artificial valve structure, the second stent 20 is released first. At this time, the first stent 10 has not yet been completely released, so the position of the second stent 20 is adjusted according to the actual situation to position the second positioning section 22 of the second stent 20 on the second side 202 of the cardiac valve annulus. After that, the first stent 10 is released, thereby achieving the release of the artificial valve stent 100. In this way, before releasing the second stent 20, after the sheath 300 has entered the target position, it is not necessary to release the artificial valve stent only after precisely positioning the sheath 300 as in the conventional technique. The second stent 20 can be released into the ventricular region of the second side 202 of the cardiac valve annulus. After releasing the second stent 20, the position of the sheath 300 can be finely adjusted so that the second positioning part 22 of the second stent 20 is positioned on the second side 202 of the cardiac valve annulus, and then the first stent 10 can be released directly. Furthermore, it is possible to ensure that the first positioning part 12 and the second positioning part 22 are precisely positioned on the first side 201 and the second side 202 of the cardiac valve annulus, respectively, thereby reducing the difficulty of positioning for release of the artificial valve structure and improving the ease of the release operation.

[0050] The cardiac valve annulus 200 includes a first side 201 and a second side 202, where the first side 201 is the atrial side and the second side 202 is the ventricular side. Blood flows from the first side 201 to the second side 202, that is, from the atrial side to the ventricular side.

[0051] In some embodiments, the first stent 10 is provided with a first connection hole 1130, and the connection portion 21 is provided with a second connection hole 2223. The artificial valve stent 100 further includes a connecting member for connecting the first stent 10 and the second stent 20, the connecting member being inserted into the first connection hole 1130 and the second connection hole 2223. By connecting the first stent 10 with the first connection hole 1130 and the connection portion 21 with the second connection hole 2223, and passing the connecting member through the first connection hole 1130 and the second connection hole 2223, the first stent 10 and the second stent 20 can be processed individually during production. This reduces the difficulty of processing the artificial valve stent 100, and when assembling, the first stent 10 and the second stent 20 only need to be connected using the connecting member, making the operation simple.

[0052] The first stent 10 and the second stent 20 may be connected by a hard connection or a soft connection. For example, the connecting member may be a rivet or a screw, and the first stent 10 and the second stent 20 may be connected by a hard connection by passing the connecting member through the first connection hole 1130 and the second connection hole 2223. Alternatively, the connecting member may be a traction wire or a flexible thread, and the first stent 10 and the second stent 20 may be connected by a soft connection by passing the traction wire or flexible thread through the first connection hole 1130 and the second connection hole 2223 and tying and tightening it. Of course, the connecting member should be determined specifically according to the actual situation.

[0053] Furthermore, the first positioning portion 12 may be located at any position on the first stent body 11, such as the upstream end or the middle portion of the first stent body 11.

[0054] For example, if we define the upstream and downstream directions along the direction of blood flow in the blood passage 30, the first positioning unit 12 is installed at the upstream end of the first stent body 11.

[0055] In some embodiments, referring to Figures 5 and 6, the first positioning section 12 includes a plurality of first positioning units 121, which are arranged circumferentially, and each first positioning unit 121 includes two first positioning rod-shaped structures 1210. Two first positioning rod-shaped structures 1210 of the same first positioning unit 121 are connected at their ends spaced apart from the flow path 30 to form a first positioning point 1211, and the first positioning points 1211 of the plurality of first positioning units 121 are spaced apart along the circumferential direction. Two first positioning rod-shaped structures 1210 belonging to two adjacent first positioning units 121 are connected such that they form a first connection point 1212 at the end closest to the flow path 30. By arranging the plurality of first positioning units 121 along the circumferential direction, the plurality of first positioning units 121 can cooperate to achieve circumferential positioning of the first side 201 of the cardiac valve annulus. Each first positioning unit 121 includes two first positioning rod-shaped structures 1210, the ends of which are spaced apart from the flow path 30 are connected to form a first positioning point 1211, and multiple positions on the first side 201 of the cardiac valve annulus are achieved by utilizing the first positioning point 1211 in each first positioning unit 121, resulting in a simple structure and high positioning stability.

[0056] The number of first positioning units 121 can be four, five, or six, and in this embodiment, there are six first positioning units 121, which are distributed at equal intervals in the circumferential direction. The first positioning rod structure 1210 may be a straight rod structure or a curved rod structure. In this embodiment, the first positioning rod structure 1210 is a curved rod structure.

[0057] In some embodiments, with further reference to Figures 5 and 6, the first positioning unit 12 further includes a plurality of second positioning units 122, with one second positioning unit 122 positioned between two adjacent first positioning units 121. Each second positioning unit 122 includes two second positioning rod structures 1220, where the ends of the two second positioning rod structures 1220 spaced apart from the flow path 30 are connected to a second positioning point 1221, the first positioning point 1211 and the second positioning point 1221 are alternately positioned along the circumferential direction, and the ends of the second positioning rod structures 1220 closer to the flow path 30 are connected to a first positioning rod structure 1210. A second positioning unit 122 is installed between two adjacent first positioning units 121, and the ends of the two second positioning rod-shaped structures 1220 in the second positioning unit 122 are connected at the ends spaced apart from the flow path 30 to form a second positioning point 1221. The first positioning point 1211 and the second positioning point 1221 are alternately installed along the circumferential direction, thereby increasing the number of positioning points of the first positioning unit 12 on the first side 201 of the heart valve annulus in the circumferential direction, making the positioning points of the first positioning unit 12 on the first side 201 of the heart valve annulus more densely packed, reducing the force received by each positioning point, and further improving the integration of the first positioning unit 12 as the second positioning unit 122 leans against the first positioning unit 121 and the two are connected as a single unit, thereby improving the stability of the first positioning unit 12.

[0058] If there are six first positioning units 121, then there are also six second positioning units 122. Furthermore, the second positioning rod structure 1220 may be a straight rod structure or a curved rod structure. In this embodiment, the second positioning rod structure 1220 is a curved rod structure.

[0059] In some embodiments, referring to Figures 5 and 6, the first positioning unit 12 further includes a plurality of third positioning units 123, which are arranged circumferentially, and each third positioning unit 123 includes two third positioning rod-shaped structures 1230. Two third positioning rod-shaped structures 1230 of the same third positioning unit 123 are connected at one end away from the flow path 30 to form a third positioning point 1231, and the third positioning points 1231 of the plurality of third positioning units 123 are spaced apart circumferentially, with the first positioning point 1211 protruding further than the third positioning point 1231 in the direction away from the flow path 30. Two third positioning rod-shaped structures 1230 belonging to two adjacent third positioning units 123 are connected such that they form a first connection point 1212 at the end closest to the flow path 30.

[0060] The first positioning section 12 further includes a plurality of third positioning units 123, each third positioning unit 123 including two third positioning rod-shaped structures 1230, the ends of the two third positioning rod-shaped structures 1230 spaced apart from the flow path 30 are connected to form a third positioning point 1231, thereby increasing the number of positioning points of the first positioning section 12 relative to the first side 201 of the heart valve annulus. Furthermore, the first positioning point 1211 protrudes further than the third positioning point 1231 in the direction away from the flow path 30, that is, the third positioning point 1231 is located inside the first positioning point 1211, thereby enabling the first positioning section 12 to achieve positioning of the first side 201 of the heart valve annulus by multiple points in the radial direction, thereby improving the stability of the positioning of the first positioning section 12 relative to the first side 201 of the heart valve annulus. The two third positioning rod-shaped structures 1230, each belonging to one of the two adjacent third positioning units 123, are connected such that they form a first connection point 1212 at the end closest to the flow path 30. This connects the first positioning unit 121 and the third positioning unit 123 as a single unit, improving the integrity of the first positioning section 12.

[0061] If there are six first positioning units 121, then there are also six third positioning units 123. The third positioning rod structure 1230 may be a straight rod structure or a curved rod structure. In this embodiment, the third positioning rod structure 1230 is a curved rod structure.

[0062] In some embodiments, referring to Figure 6, the first stent body 11 includes a plurality of support units 110, which are arranged circumferentially to define and form a flow path 30. Each of the support units 110 includes a first support rod structure 111 and a second support rod structure 112. Within the same support unit 110, the upstream end of the first support rod structure 111 and the upstream end of the second support rod structure 112 are connected to two first connection points 1212, respectively, and the downstream end of the first support rod structure 111 and the downstream end of the second support rod structure 112 are connected to form a second connection point 113. In the plurality of support units 110, the upstream end of the first support rod structure 111 and the upstream end of the second support rod structure 112 are connected to two first connection points 1212, respectively, thereby connecting the plurality of support units 110 and the first positioning unit 12 as a single unit.

[0063] The first support rod structure 111 and the second support rod structure 112 may be straight rod structures or curved rod structures. In this embodiment, the first support rod structure 111 and the second support rod structure 112 are curved rod structures.

[0064] In some embodiments, referring to Figure 6, a first connection hole 1130 for connecting to the second stent 20 is provided at the second connection point 113. Since the second connection point 113 is located at the downstream end of the first support rod structure 111 and the downstream end of the second support rod structure 112, and the first connection hole 1130 for connecting to the second stent 20 is provided at the second connection point 113, the second stent 20 is connected to the downstream end of the first stent 10, thereby contributing to ensuring that after the second stent 20 is released, only the downstream end portion of the first stent 10 is inflated by the second stent 20, and that after the second stent 20 is fully released, the upstream end of the first stent 10 remains located within the sheath 300.

[0065] The number of first connection holes 1130 may be one or multiple. In this embodiment, the number of first connection holes 1130 is two.

[0066] In some embodiments, the number of first positioning units 121 is twice the number of support units 110. Within the same support unit 110, the upstream end of the first support rod structure 111 and the upstream end of the second support rod structure 112 are connected to two alternate first connection points 1212, respectively.

[0067] If there are six first positioning units 121, then there are three support units 110.

[0068] Furthermore, since the upstream end of the first support rod structure 111 and the upstream end of the second support rod structure 112 are connected to two alternate first connection points 1212, there are some first connection points 1212 among the multiple first connection points 1212 that are not connected to the support unit 110.

[0069] In some embodiments, each support unit 110 further includes a third support rod structure 114 and a fourth support rod structure 115. The third support rod structure 114 has one end connected to a first connection point 1212 located between the first support rod structure 111 and the second support rod structure 112, and the other end connected to the middle portion of the first support rod structure 111. The fourth support rod structure 115 has one end connected to a first connection point 1212 located between the first support rod structure 111 and the second support rod structure 112, and the other end connected to the middle portion of the second support rod structure 112. The third support rod structure 114 and the second support rod structure 112 are installed, and one end of the third support rod structure 114 is connected to a first connection point 1212 located between the first support rod structure 111 and the second support rod structure 112. As a result, all first connection points 1212 in the first positioning unit 121 are connected to be supported in accordance with the support unit 110, preventing the phenomenon of unconnected first connection points 1212 and ensuring the overall stability of the first stent 10.

[0070] The third support rod structure 114 and the fourth support rod structure 115 may be straight rod structures or curved rod structures. In this embodiment, the third support rod structure 114 and the fourth support rod structure 115 are curved rod structures.

[0071] In some embodiments, referring to Figures 7 and 8, the connection portion 21 is located radially outward of the first stent body 11, the second positioning portion 22 extends radially outward from the connection portion 21 and is located upstream of the connection portion 21, the second positioning portion 22 includes a plurality of fourth positioning units 221, and the plurality of fourth positioning units 221 are installed along the circumferential direction. By having the second positioning portion 22 include a plurality of fourth positioning units 221 and positioning the plurality of circumferentially distributed fourth positioning units 221 on the second side 202 of the cardiac valve annulus, positioning at multiple locations can be achieved, preventing the occurrence of weak positioning locations in the circumferential direction of the second stent 20 and ensuring the positioning stability of the second stent 20.

[0072] In some embodiments, referring to Figures 7 and 8, each fourth positioning unit 221 includes two fourth positioning rod structures 2210. Two fourth positioning rod structures 2210 of the same fourth positioning unit 221 are connected at their ends spaced apart from the flow path 30 to form a fourth positioning point 2211, and the fourth positioning points 2211 of multiple fourth positioning units 221 are spaced apart along the circumferential direction, and two fourth positioning rod structures 2210 belonging to two adjacent fourth positioning units 221 are connected such that they form a third connection point 2212 at the end closest to the flow path 30. Each fourth positioning unit 221 includes two fourth positioning rod-shaped structures 2210, the two fourth positioning rod-shaped structures 2210 connected at one end spaced apart from the flow path 30 to form a fourth positioning point 2211, and the fourth positioning point 2211 in each fourth positioning unit 221 is used to achieve multi-point positioning of the second side 202 of the heart valve annulus, and the fourth positioning unit 221 has a simple structure and high positioning stability.

[0073] The fourth positioning rod structure 2210 may be a straight rod structure or a curved rod structure. In this embodiment, the fourth positioning rod structure 2210 is a curved rod structure.

[0074] In some embodiments, with further reference to Figures 7 and 8, the second positioning unit 22 further includes a plurality of fifth positioning units 222, which are arranged circumferentially and located downstream of the fourth positioning unit 221, with each fifth positioning unit 222 including two fifth positioning rod structures 2220. Two fifth positioning rod structures 2220 of the same fourth positioning unit 221 are connected at their ends spaced apart from the flow path 30 to form a fifth positioning point 2221, and the fifth positioning points 2221 of the plurality of fifth positioning units 222 are spaced apart along the circumferential direction. Two fifth positioning rod structures 2220 belonging to two adjacent fifth positioning units 222 are connected such that they form a fourth connection point 2222 at their ends close to the flow path 30.

[0075] The second positioning section 22 further includes a plurality of fifth positioning units 222 distributed in the circumferential direction, the fifth positioning units 222 being located downstream of the fourth positioning unit 221, and the two fifth positioning rod-shaped structures 2220 in the fifth positioning unit 222 are connected at ends spaced apart from the flow path 30 to form a fifth positioning point 2221, thereby positioning the second stent 20 at multiple points in the direction of extension of the flow path 30, improving the effectiveness and stability of positioning between the second stent 20 and the second side 202 of the cardiac valve annulus.

[0076] The fifth positioning rod structure 2220 may be a straight rod structure or a curved rod structure. In this embodiment, the fifth positioning rod structure 2220 is a curved rod structure.

[0077] In some embodiments, referring to Figure 8, the connection portion 21 includes a plurality of fifth support rod-shaped structures 210, which are arranged at intervals along the circumferential direction, with one end of each fifth support rod-shaped structure 210 connected to a third connection point 2212 and the other end connected to a fourth connection point 2222. The fourth positioning unit 221 and the fifth positioning unit 222 are connected integrally via the fifth support rod-shaped structures 210, thereby connecting the second positioning portion 22 and the connection portion 21 integrally and ensuring the integrity of the second stent 20.

[0078] In some embodiments, a second connection hole 2223 for connecting to the first stent 10 is provided at the fourth connection point 2222. Since the fourth connection point 2222 is located at the downstream end of the fifth support rod structure 210 and the second connection hole 2223 for connecting to the first stent 10 is provided at the fourth connection point 2222, the downstream end of the second stent 20 is connected to the downstream end of the first stent 10, and after the second stent 20 is released, the second stent 20 can be fully released, and the release of the second stent 20 causes only the downstream end portion of the first stent 10 to expand, which helps to ensure that the upstream end of the first stent 10 remains located inside the sheath 300 after the second stent 20 is fully released.

[0079] If there are two first connection holes 1130 at the second connection point 113, then there are also two second connection holes 2223 at the fourth connection point.

[0080] Embodiments of this application provide an artificial valve structure. The artificial valve structure includes a valve (not shown) and an artificial valve stent 100, the valve being located in the flow path 30 of a first stent body 11.

[0081] In some embodiments, the artificial valve structure includes a cover member (not shown, but made of cloth and provided to cover the outside of the stent), which is installed on the outside of the second stent 20 and / or the first stent 10, with the inside of the cover member extending to the valve. The installation of the cover member on the outside of the second stent 20, with the inside of the cover member extending to the valve, covers and shields the outside of the second stent 20 and / or the first stent 10, preventing blood from flowing back from the second side 202 of the valve annulus to the first side 201 of the valve annulus, and ensuring that blood flows only from the first side 201 to the second side 202 of the valve annulus.

[0082] In this embodiment, the cover member is installed on the outside of the second stent 20, and the inside of the cover member extends to the lower edge of the valve.

[0083] An embodiment of this application provides a method for releasing an artificial valve structure. The release method includes the following steps: Specifically, referring to Figures 9 and 10, releasing the second stent 20 of the artificial valve structure and extending the second stent 20 radially; referring to Figure 11, adjusting the second stent 20 until the second positioning portion 22 is positioned on the second side of the target annular object; and referring to Figure 12, releasing the first stent 10 of the artificial valve structure and positioning the first positioning portion 12 of the first stent 10 on the first side of the target annular object.

[0084] This release method can be used on animal carcasses, animal or human body models, and is used to measure the release state of an artificial valve structure, the magnitude of the force during release, etc. The target annular object described above may be a cardiac valve annulus in an animal carcass or human body model, for example, a mitral valve annulus or a tricuspid valve annulus. In this embodiment, the target annular object is exemplified by a mitral valve annulus and is hereinafter referred to as the cardiac valve annulus. The first side of the target annular object, i.e., the first side 201 of the cardiac valve annulus, is the side of the cardiac valve annulus 200 that is closer to the atrium. The second side of the target annular object, i.e., the second side 202 of the cardiac valve annulus, is the side of the cardiac valve annulus 200 that is closer to the ventricle.

[0085] The artificial valve stent 100 allows the second stent 20 to self-inflate if the first stent 10 is not yet fully released, so that the second stent 20 does not become completely tightly attached to the second side 202 of the cardiac valve annulus. After the second stent 20 is released, the position of the artificial valve stent 100 can be adjusted even if the upstream end of the first stent 10 is not released. Since the position of the second stent 20 can be finely adjusted even after it has been released, a certain degree of error in the tightness of the second stent 20 to the second side 202 of the cardiac valve annulus is acceptable, reducing the difficulty of positioning the release of the artificial valve structure and improving the ease of the release operation. After adjusting the position of the sheath 300, the first stent 10 can be directly released with the second positioning portion 22 of the already released second stent 20 positioned on the second side 202 of the cardiac valve annulus. This ensures that the first positioning portion 12 and the second positioning portion 22 are precisely positioned on the first side 201 and the second side 202 of the cardiac valve annulus, respectively, enabling precise release of the artificial valve stent 100, reducing the difficulty of the surgery, and lowering the risk of the surgery.

[0086] In some embodiments, adjusting the second stent 20 involves adjusting the angle of the second stent 20 relative to the cardiac valve annulus 200, and positioning the second positioning portion 22 on the second side 202 of the cardiac valve annulus involves pulling the second stent 20 so that the second positioning portion 22 is close to the cardiac valve annulus 200. In this way, when adjusting the position of the second stent 20, not only the angle of the second stent 20 relative to the cardiac valve annulus 200 but also the distance between the second stent 20 and the cardiac valve annulus 200 can be adjusted, thereby achieving precise positioning of the second stent 20 and the second side 202 of the cardiac valve annulus.

[0087] Specifically, as shown in Figure 13, since fine adjustments are possible even after the second stent 20 has been released, a certain degree of error is allowed in ensuring that the second stent 20 is in perfect contact with the second side 202 of the cardiac valve annulus. Therefore, during the release process, a certain degree of angle is allowed in the angle of the sheath 300 with respect to the plane of the cardiac valve annulus 200. As shown in Figure 13, the allowable angle is symmetrical with respect to the center, with respect to the direction perpendicular to the plane of the cardiac valve annulus, and the maximum allowable angle a is 50°. This reduces the requirement for precise positioning, thus making the operation easier and expanding the range of application for such an artificial valve stent 100 structure. Furthermore, the time required for positioning before releasing the second stent 20 can be reduced because adjustments made if the second stent 20 is not in perfect contact with the second side 202 of the cardiac valve annulus after release are simpler and take less time than the positioning operation before release.

[0088] After the second stent 20 is released and adjusted, it plays a positioning role in ensuring that it makes close contact with the second side 202 of the valve annulus, and then smoothly makes close contact with the first side 201 of the valve annulus after the first stent 10 is released. After the second stent 20 is released first and makes close contact with the second side 202 of the valve annulus, the first stent 10 can make a more secure contact with the first side 201 of the valve annulus under the traction of the second stent 20 during the self-expansion process after the first stent 10 is released. As shown in Figure 14, the sheath 300 can be accurately released even if a certain degree of angular displacement is allowed with respect to the plane in which the valve annulus is located. Similarly, the allowable range of angular displacement at this time is defined as the displacement range b centered in the direction perpendicular to the plane of the valve annulus. Furthermore, because this angle is greater than the angle a mentioned above, after releasing the second stent 20 in the first stage and making close contact with the plane of the valve annulus, it is unnecessary to adjust the angle of the sheath 300 with respect to the plane on which the cardiac valve annulus is located, and the first stent 10 can be released directly, thereby achieving the release and positioning of the artificial valve stent 100.

[0089] The features in the embodiments of this application can be combined with each other, provided they do not contradict each other.

[0090] The foregoing describes only preferred embodiments of this application and does not limit it. This application may have various modifications and changes for those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made without departing from the spirit and principles of this application shall fall within the scope of protection of this application.

[0091] Industrial applicability This application provides an artificial valve stent, an artificial valve structure, and a release method, thereby reducing the difficulty of releasing the artificial valve structure and improving the ease of the release operation.

[0092] Furthermore, the artificial valve stent, artificial valve structure, and release method described in this application are feasible and can be widely used in the field of medical technology. [Explanation of Symbols]

[0093] 10 Stent 1 11. Main body of the first stent 110 Support Unit 111 1st support rod structure 112 Second support rod structure 113 Second connection point 1130 First connection hole 114 Third support rod structure 115 4th support rod structure 12 First positioning unit 121 First positioning unit 1210 First positioning rod-shaped structure 1211 First positioning point 1212 1st connection point 122 Second positioning unit 1220 Second positioning rod-shaped structure 1221 Second positioning point 123 Third positioning unit 1230 Third positioning rod-shaped structure 1231 Third positioning point 20 Stent 2 21 Connection part 210 5th support rod structure 22 Second positioning unit 221 Fourth positioning unit 2210 Fourth positioning rod-shaped structure 2211 Fourth positioning point 2212 Third connection point 222 Fifth Positioning Unit 2220 Fifth positioning rod-shaped structure 2221 Fifth positioning point 2222 4th connection point 2223 Second connection hole 30 flow channels 100 Artificial valve stents 200 Heart valve ring 201 First side of the cardiac valve annulus 202 Second side of the cardiac valve annulus 300 sheath

Claims

1. Including the first stent and the second stent, The first stent includes a first stent body and a first positioning portion for positioning on the first side of the cardiac valve annulus, the first stent body has a defined flow path for blood to flow through it, and the first positioning portion extends radially outward from the first stent body. The second stent includes a connecting portion located radially outside the first stent body and connected to the first stent body, and a second positioning portion for positioning on the second side of the cardiac valve annulus. An artificial valve stent characterized by the following features.

2. The first stent is provided with a first connection hole, and the connection portion is provided with a second connection hole. The artificial valve stent further includes a connecting member for connecting the first stent and the second stent, wherein the connecting member is inserted into the first connecting hole and the second connecting hole. The artificial valve stent according to feature 1.

3. When the upstream and downstream directions are defined along the direction in which blood flows through the aforementioned channel, the first positioning unit is installed at the upstream end of the first stent body. The artificial valve stent according to feature 1.

4. The first positioning section includes a plurality of first positioning units, the plurality of first positioning units are arranged along the circumferential direction, and each of the first positioning units includes two first positioning rod-shaped structures. Two identical first positioning rod-shaped structures of the first positioning unit are connected at their ends, which are spaced apart from the flow path, to form a first positioning point, and the first positioning points of multiple first positioning units are arranged at intervals along the circumferential direction. Two first positioning rod-shaped structures, each belonging to two adjacent first positioning units, are connected such that they form a first connection point at the end closest to the flow path. The artificial valve stent according to claim 3.

5. The first positioning unit further includes a plurality of second positioning units, with one second positioning unit installed between two adjacent first positioning units. Each of the second positioning units includes two second positioning rod-shaped structures, the ends of which are spaced apart from the flow path are connected to form a second positioning point, the first positioning point and the second positioning point are alternately arranged along the circumferential direction, and the ends of the second positioning rod-shaped structures that are close to the flow path are connected to the first positioning rod-shaped structures. The artificial valve stent according to feature 4.

6. The first positioning unit further includes a plurality of third positioning units, the plurality of third positioning units are arranged along the circumferential direction, and each of the third positioning units includes two third positioning rod-shaped structures. Two of the same third positioning rod-shaped structures of the third positioning unit are connected at their ends spaced apart from the flow path to form a third positioning point, and the third positioning points of the multiple third positioning units are spaced apart along the circumferential direction, with the first positioning point protruding more than the third positioning point in the direction away from the flow path. Two third positioning rod-shaped structures, each belonging to two adjacent third positioning units, are connected such that they form the first connection point at the end closest to the flow path. The artificial valve stent according to claim 5.

7. The first stent body includes a plurality of support units, the plurality of support units are arranged circumferentially to define and form the flow path, Each of the support units includes a first support rod structure and a second support rod structure, and in the same support unit, the upstream end of the first support rod structure and the upstream end of the second support rod structure are connected to two first connection points, and the downstream end of the first support rod structure and the downstream end of the second support rod structure are connected to form a second connection point. The artificial valve stent according to feature 4.

8. A first connection hole for connecting to the second stent is provided at the second connection point. The artificial valve stent according to feature 7.

9. The number of the first positioning units is twice the number of the support units, In the same support unit, the upstream end of the first support rod structure and the upstream end of the second support rod structure are connected to two alternate first connection points, respectively. The artificial valve stent according to feature 7.

10. Each of the support units further includes a third support rod structure and a fourth support rod structure, The third support rod-shaped structure has one end connected to the first connecting point located between the first support rod-shaped structure and the second support rod-shaped structure, and the other end connected to the intermediate portion of the first support rod-shaped structure. The fourth support rod-shaped structure has one end connected to the first connecting point located between the first support rod-shaped structure and the second support rod-shaped structure, and the other end connected to the intermediate portion of the second support rod-shaped structure. The artificial valve stent according to feature 9.

11. The connection portion is located radially outward of the first stent body, the second positioning portion extends radially outward from the connection portion and is located upstream of the connection portion, the second positioning portion includes a plurality of fourth positioning units, and the plurality of fourth positioning units are installed along the circumferential direction. The artificial valve stent according to feature 1.

12. Each of the fourth positioning units includes two fourth positioning rod-shaped structures, Two of the same fourth positioning rod-shaped structures of the fourth positioning unit are connected at their ends, which are spaced apart from the flow path, to form a fourth positioning point, and the fourth positioning points of multiple fourth positioning units are arranged at intervals along the circumferential direction. Two of the fourth positioning rod-shaped structures, each belonging to two adjacent fourth positioning units, are connected such that they form a third connection point at the end closest to the flow path. The artificial valve stent according to feature 11.

13. The second positioning unit further includes a plurality of fifth positioning units, the plurality of fifth positioning units are arranged circumferentially, the fifth positioning units are located downstream of the fourth positioning unit, and each of the fifth positioning units includes two fifth positioning rod-shaped structures. Two of the same fourth positioning units have their ends spaced apart from the flow path connected to form a fifth positioning point, and the fifth positioning points of multiple fifth positioning units are spaced apart along the circumferential direction. Two of the fifth positioning rod-shaped structures, each belonging to two adjacent fifth positioning units, are connected such that they form a fourth connection point at the end closest to the flow path. The artificial valve stent according to claim 12.

14. The connecting portion includes a plurality of fifth support rod-shaped structures, the plurality of fifth support rod-shaped structures are arranged at intervals along the circumferential direction, and each fifth support rod-shaped structure has one end connected to the third connecting point and the other end connected to the fourth connecting point. The artificial valve stent according to feature 13.

15. A second connection hole for connecting to the first stent is provided at the fourth connection point. The artificial valve stent according to feature 13.

16. The number of the first positioning units is six, and the six first positioning units are distributed at equal intervals in the circumferential direction. An artificial valve stent according to any one of claims 4 to 10.

17. The invention comprises a valve and an artificial valve stent according to any one of claims 1 to 16, wherein the valve is located in the flow path of the first stent body. An artificial valve structure characterized by the following features.

18. The artificial valve structure includes a cover member, the cover member being installed on the outside of the second stent and / or the second stent, and the inside of the cover member extending to the valve. The artificial valve structure according to feature 17.

19. A method for releasing an artificial valve structure according to claim 16 or 17, Step (a) involves releasing the second stent of the artificial valve structure, deploying the second stent radially, and adjusting the second stent until the second positioning portion is positioned on the second side of the target annular object. The procedure includes (b) releasing the first stent of the artificial valve structure and positioning the first positioning portion of the first stent on the first side of the target annular object. A method for releasing an artificial valve structure, characterized by the following features.

20. Adjusting the second stent in step (a) means adjusting the angle of the second stent with respect to the target annular object, and positioning the second positioning part on the second side of the target annular object means pulling the second stent so that the second positioning part is brought close to the target annular object. The method for releasing an artificial valve structure according to feature 19.

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