Separate, precisely anchored transcatheter tricuspid valve system

Abstract

A separate, precisely anchored transcatheter tricuspid valve system includes a separate transcatheter tricuspid valve anchor stent (10) and a transcatheter biological tricuspid valve (20), the shape and structure of the transcatheter tricuspid valve anchor stent (10) matching the true structure of the tricuspid valve reconstructed three-dimensionally based on patient image data, the transcatheter tricuspid valve anchor stent (10) first delivered to the patient's tricuspid valve position for release, deformation, and personalized alignment and coaptation with the patient's supravalvular (40) and infravalvular (50) tissues, the transcatheter biological tricuspid valve (20) delivered within the transcatheter tricuspid valve anchor stent (10) and released, the transcatheter biological tricuspid valve (20) released, deformed, and expanded to a functional state, and the transcatheter tricuspid valve anchor stent (10) is again deformed and expanded. Transcatheter prosthetic biological tricuspid valve The transcatheter tricuspid valve system, which allows for precise anchoring, is designed based on three-dimensional reconstruction, and is capable of achieving a pre-set connection between the anchor stent (10) and the subvalvular tissue (50) by simultaneously deforming the transcatheter tricuspid valve anchor stent (10) and the subvalvular tissue (50). Transcatheter prosthetic biological tricuspid valve It is possible to achieve a unique and precise anchor.

Description

[Technical Field]

[0001] The present invention relates to prosthetic biological heart valves, and more particularly to a transcatheter tricuspid valve system that allows for separate, precise anchoring. [Background technology]

[0002] The tricuspid valve functions as a check valve that allows blood to return to the first inlet of the heart. Most valvular dysfunction is regurgitation (TR), which is mainly secondary lesions. Lesions of the valvular valves at other valve positions follow simultaneously. If the condition continues to worsen and timely treatment is not given, massive regurgitation will occur, leading to cardiac dysfunction and even death. Mitral valve Compared with the right tricuspid and aortic valves, research and treatment of the right tricuspid and pulmonary valves have long been neglected, and their harms have been underestimated. In recent years, the number of cases of surgical tricuspid valve repair and replacement has been increasing year by year. For elderly patients with multiple underlying diseases, surgical valve replacement not only carries high risks, but also often results in unsatisfactory therapeutic outcomes. Due to the large number of TR patients in China who require treatment, transcatheter aortic valve replacement (TAVR) has been an effective treatment for elderly or high-risk patients with traditional surgical aortic valve replacement. In the past decade, research on transcatheter tricuspid valve repair and replacement devices has made significant progress. In particular, transcatheter tricuspid valve replacement is considered the etiological treatment for such patients. However, because the tricuspid valve is an intracavitary valve in the right heart, Mitral valveCompared to the left ventricle, the right ventricle has a larger, non-flat, elliptical, and softer annular tissue, many annuli lacking calcification, and the right ventricle wall is thinner than the left. The right coronary artery is located adjacent to the annulus, and the conduction beam is adjacent. This creates a relatively complex perivalvular environment, with the annulus and supravalvular and infravalvular structures undergoing significant deformation with each cardiac cycle. These diverse and complex anatomical forms and structures make it difficult to design a transcatheter tricuspid prosthetic valve that, like the transcatheter aortic valve, has supravalvular shape and perivalvular radial support. The design concepts and structural features of conventional transcatheter tricuspid valve products and patents for similar products rely on implantation with a disposable catheter and a one-piece valve structure (Figures 1-2), making it difficult to meet the unique and complex pathological environment of the tricuspid valve. Summary of the Invention

[0003] The transcatheter tricuspid valve system of the present invention differs from the design concept of conventional transcatheter tricuspid valve products in that it provides a transcatheter tricuspid valve system capable of separate, precise anchoring. Separately, the product is composed of two independent devices: a transcatheter tricuspid valve anchor stent and a transcatheter prosthetic tricuspid valve. The former is first delivered to the tricuspid valve location via a catheter and released, and the latter is then approached and deformed at the tricuspid valve location with the aid of external force from balloon inflation, and then integrated at the affected valve location, thereby achieving individual, precise anchoring of the affected valve tissue.

[0004] The transcatheter tricuspid valve system of the present invention differs from the structure of conventional transcatheter tricuspid valve products in that it has a transcatheter tricuspid valve anchor stent and a transcatheter tricuspid valve anchor stent. Prosthetic bioprosthetic tricuspid valve The valve anchor and the valve closure are constructed in cooperation. valve leaflets The support is divided into two different structures: a separate transcatheter tricuspid valve anchor stent is responsible for anchoring the valve leaflets, and the transcatheter prosthetic tricuspid valve is delivered and released into the pre-catheterized anchor stent, similar to the valve in the transcatheter valve, and then combined with the stent to achieve precise anchoring.

[0005] The transcatheter tricuspid valve system of the present invention includes a separate tricuspid valve anchor stent and a two-part transcatheter tricuspid valve that can be accurately anchored. One of the gist of the present invention is that the transcatheter tricuspid valve anchor stent has two anchor states with different shapes and structures, namely, a first anchor state after being released through a catheter, and Transcatheter prosthetic biological tricuspid valve and a second anchor state after being bound to the

[0006] The first anchor state is customized based on the true structure and morphology of the tricuspid valve, which is three-dimensionally reconstructed based on the patient's unique image data, and is customized through in vitro three-dimensional molding and processing. Therefore, after being released through the catheter, the shape can be accurately aligned with and bonded to the supravalvular and subvalvular tissues at the patient's tricuspid valve, and the transcatheter tricuspid valve anchor stent has a funnel shape from the atrial surface to the ventricular surface, and after being released, the shape accurately aligns with and sandwiches the supravalvular and subvalvular tissues of the patient's dynamic lesion. The processing and shaping of the first anchor state of the transcatheter tricuspid valve anchor stent depend on how accurately the transcatheter tricuspid valve anchor stent matches the true anatomical structure of the patient's tricuspid valve. The three-dimensionally reconstructed true structure is a digital image model or a 3D printing simulation solid model, and the three-dimensionally reconstructed true structure is a virtual simulation three-dimensional image after digitalizing and converting integrated images of CT, ultrasound, and nuclear magnetic resonance, and a corresponding 3D printing simulation solid model.

[0007] The first anchor state of the transcatheter tricuspid valve anchor stent is an umbrella-shaped stent structure designed based on the true anatomical morphology of a patient's tricuspid valve reconstructed three-dimensionally, and is composed of three parts: an atrial surface, a ventricular surface, and a connecting portion of the anchor stent between them. The (1) atrial surface is umbrella-shaped and conforms to the true anatomical morphology reconstructed three-dimensionally based on image data of the patient's atrial surface. This is the first lattice portion, which is deployed after being placed above the tricuspid valve annulus at the bottom of the right atrium. The (2) ventricular surface has three positioning hooks and loops accurately set at the boundary positions of the three leaflets of the patient's tricuspid valve, i.e., the anterior, posterior, and posterior valves. After being deployed, the atrial surface of the positioning anchor stent is deployed in a manner unique to the anatomical morphology of the patient's right atrium. The (3) connecting portion of the anchor stent is round-nosed funnel-shaped and is the second lattice portion. What has been described so far is a unique three-dimensional structure in which the first anchor state of the transcatheter tricuspid valve anchor stent is released entirely within the catheter and detached from the catheter.

[0008] The second anchor state of the transcatheter tricuspid valve anchor stent is a state in which, in the first anchor state, a transcatheter biological tricuspid valve prosthesis is delivered into the transcatheter tricuspid valve anchor stent in the first state via a catheter, and the transcatheter biological tricuspid valve prosthesis is fixed by an external force generated by balloon expansion. Transcatheter prosthetic biological tricuspid valve As the transcatheter tricuspid valve anchor stent expands, it undergoes a secondary deformation, transforming from the original conical (funnel-like) shape of the first anchor state to a final cylindrical shape, and is integrally bonded to the expanded transcatheter tricuspid valve prosthesis. At the same time, the structure of the ventricular surface of the transcatheter tricuspid valve anchor stent in the second anchor state is finally bonded to the chordae tendineae and papillary muscles of the patient's tricuspid valve, thereby achieving an accurate, preset bond and anchoring.

[0009] The first anchoring state of the connecting portion of the transcatheter tricuspid valve anchor stent is a three-dimensional fixed-shape memory state that corresponds to the patient's true anatomical morphology and structure after delivery and release via a catheter. The fixed-shape memory state of the connecting portion from the atrial surface to the ventricular surface has a contraction gradient of 5 to 45 degrees, which is determined according to the morphology of the patient's affected valve leaflets. The connecting portion of the anchor stent deforms from a conical funnel shape in the first anchoring state to a cylindrical second anchoring state through deformation and expansion. In the first anchoring state of the transcatheter tricuspid valve anchor stent, the positioning hook loop is inserted into the boundary position of the anterior, posterior, and posterior leaflets of the corresponding affected tricuspid valve after delivery via a catheter, thereby achieving a personalized correspondence between the atrial surface of the anchor stent and the morphology of the patient's right atrium. The ventricular surface of the tricuspid valve anchor stent has a plurality of anchor hook loops, which extend from the connection portion to the right ventricular surface and then fold back, accurately matching the number, size, shape, and fold-back angle of the anchor hook loops to the true chordae tendineae and the shape of the subvalvular tissue structure three-dimensionally reconstructed based on the subvalvular image data of the patient's lesioned tricuspid valve. The number, size, shape, and fold-back angle of the anchor hook loops individually and accurately match the true chordae tendineae gaps, the size and shape of the tricuspid valve leaflets, and the circumferential distance between the ventricular wall and the perivalvular tissue, all three-dimensionally reconstructed based on the subvalvular image data of the patient's lesioned tricuspid valve.

[0010] The second anchor state of the transcatheter tricuspid valve anchor stent is determined by designing and processing the shape, size, and bending angle of the positioning hook loops on the ventricular surface of the transcatheter tricuspid valve anchor stent based primarily on the morphology of the patient's tricuspid valve leaflets, the area size of the leaflet surfaces, and the true anatomical structure of the chordae tendineae and papillary muscles of the three leaflets, which are three-dimensionally reconstructed based on ultrasound images of the patient's tricuspid valve. The transcatheter tricuspid valve prosthesis can then be inserted in a compressed state and expanded by pressurization with a pressure pump. In this case, a number of anchor hook loops with matching shapes and structures are deformed to position themselves in the preset final anchor state, achieving a final, accurate, tight connection with the patient's tricuspid valve and the subvalvular tissue.

[0011] the transcatheter tricuspid valve anchor stent assumes a first anchored state after being released through the catheter from a compressed state disposed within the catheter; and Transcatheter prosthetic biological tricuspid valve and transforms into a second anchor state, and the three positioning hook loops at the connecting part of the anchor stent are precisely inserted into the three boundaries of the anterior, posterior, and posterior tricuspid valves after being released through the catheter to position the entire stent. The positioning hook loops not only conform to the morphology of the atrial surface of the transcatheter tricuspid valve anchor stent, the morphology of the patient's right atrium, and the amplitude of right atrial systole during the cardiac cycle, but also position the multiple anchor hook loops on the ventricular surface of the transcatheter tricuspid valve anchor stent so that they are inserted and clamped in accordance with the chordae tendineae gaps in the patient's affected tricuspid valve leaflets. When the transcatheter tricuspid valve anchor stent transforms into the second anchor state, these anchor hook loops can intertwine with the subvalvular tissue and achieve a tight, preset bond.

[0012] The transcatheter tricuspid valve anchor stent has a first anchor state after being released through a catheter, and thereafter Transcatheter prosthetic biological tricuspid valve and deformed into a second anchor state, and the end of the connecting portion of the transcatheter tricuspid valve anchor stent on the atrial surface is connected to the transcatheter tricuspid valve anchor stent. stents The tricuspid valve anchor stent is provided with a plurality of terminal centripetal hooks for inserting the outflow end of the transcatheter tricuspid valve stent, and the terminals of the terminal centripetal hooks and the tricuspid valve anchor stent are provided with a plurality of terminal centripetal hooks for inserting the outflow end of the transcatheter tricuspid valve stent at the ends of the atrial surface of the connecting portion between the centripetal hooks and the tricuspid valve anchor stent. of Multiple fixed support rods are placed around the upper and lower sides to insert the atrial end of the stent. Transcatheter prosthetic biological tricuspid valveIn a first anchoring state of the transcatheter tricuspid valve anchor stent, the fixed support rods maintain an angle that matches with the anchor stent connection portion, and in a second anchoring state of the transcatheter tricuspid valve anchor stent, the multiple fixed support rods surround each other toward the axial center and are parallel to the axial direction, and the ends of the fixed support rods are Transcatheter prosthetic biological tricuspid valve The inflow end of the stent is fitted to the Transcatheter prosthetic biological tricuspid valve and a transcatheter tricuspid valve. of The number of fixed support rods is 3 to 12, preferably 9. The first and second lattice portions of the transcatheter tricuspid valve anchor bolt are formed by unit lattices consisting of compressible diamond lattices, V lattices, and / or hexagonal or polygonal lattices, and the first and second lattice portions are adaptively connected. The distance between the outer periphery of the lattice portion on the atrial surface of the transcatheter tricuspid valve anchor stent and the patient's atrial wall is 1 to 2 mm, preferably 1.5 mm. The diameter of the inner periphery of the second lattice portion of the transcatheter tricuspid valve anchor stent matches the outer diameter of various corresponding size standards of transcatheter prosthetic tricuspid valves. A single layer of medical polymer thin film is coated on part or all of the surface of the transcatheter tricuspid valve anchor stent. The atrial and ventricular surfaces of the tricuspid valve anchor stent and the connecting portions of the anchor stent are three-dimensionally formed structures after laser cutting as a single unit, or reconnected structures after separate processing of the connecting portions of the atrial and ventricular surfaces and the anchor stent. The anchor stent is made of a metallic or non-metallic material with shape memory properties that allows it to recover its shape.

[0013] Furthermore, the transcatheter prosthetic tricuspid valve includes a cobalt-chromium alloy stent that assumes a cylindrical or partially cylindrical shape after being radially compressed and expanded by a balloon, or a nickel-titanium alloy stent that self-expands when radially compressed, and three fan-shaped leaflets provided inside the stent, each of which has a free edge, an arc-shaped base, and leaflet boundary connections extending on both sides, and the stent can be grasped in various forms such as a metal net tube or a metal tube that can support and fix the boundaries of the three leaflets. stents The above stents is a cobalt-based alloy, cobalt or chromium alloy, or nickel-titanium alloy. The transcatheter prosthetic tricuspid valve delivery kit includes a transcatheter prosthetic tricuspid valve delivery device, a guide sheath, a valve leaflet gripper, and a charge pump. The transcatheter tricuspid valve anchor stent delivery device and the transcatheter prosthetic tricuspid valve delivery device can be delivered to the tricuspid valve location from the inferior vena cava via the femoral vein or from the superior vena cava via the jugular or subclavian vein. The transcatheter tricuspid valve anchor stent is first approached to the tricuspid valve location of the patient's lesion via a catheter and released to a first anchor state, and then the transcatheter prosthetic tricuspid valve is delivered into the anchor stent via a catheter. Transcatheter prosthetic biological tricuspid valve At the same time as the catheter expands, the transcatheter tricuspid valve anchor stent is expanded to the second anchor state, and at the same time, the connection part of the stent and Transcatheter prosthetic biological tricuspid valve and complete a more intimate bond between the ventricular surface of the stent and the valve substructure, forming the final anchor.

[0014] In the present invention, accurate anchoring for individual presets of a specific patient is achieved. Transcatheter prosthetic biological tricuspid valve Each time a treatment process is completed, all of the above related data is treated as an independent data unit, and a large amount of personalized data is accumulated. By using artificial intelligence, the separate, precise anchoring transcatheter tricuspid valve system can be intelligentized, scaled up, and industrialized. [Brief explanation of the drawings]

[0015] [Figure 1] Figure 1 shows a diagram of the EVOQUE transcatheter bioprosthetic tricuspid valve. [Figure 2] Figure 2 shows an illustration of the LuX-Valve transcatheter bioprosthetic tricuspid valve. [Figure 3] 3A-C are schematic diagrams illustrating the combination of a separate anchor stent with different supravalvular and subvalvular structures and a transcatheter biological tricuspid valve prosthesis according to an embodiment of the present invention. [Figure 4] 4A to 4C are schematic diagrams of separate anchor stents having different supravalvular and subvalvular structures according to an embodiment of the present invention. [Figure 5] FIG. 5 is a schematic diagram of the atrial surface of a separate anchor stent according to an embodiment of the present invention. [Figure 6] FIG. 6 is a schematic diagram of a connection portion between the ventricular surface and the stent of a separate anchor stent according to an embodiment of the present invention. [Figure 7] 7A-C are schematic diagrams of fixed support bars and centripetal bends of a separate anchor stent according to an embodiment of the present invention. [Figure 8] 8A-B are schematic diagrams of a transcatheter tricuspid valve anchor stent according to an embodiment of the present invention in a first anchoring state after implantation into a human body. [Figure 9] 9A-B are schematic diagrams of a transcatheter tricuspid valve anchor stent according to an embodiment of the present invention in a second anchoring state after implantation into a human body. [Figure 10] FIG. 10 is a schematic diagram of the anchor hook loop and secondary anchor of the chordae tendineae after the transcatheter tricuspid valve anchor stent according to an embodiment of the present invention is implanted in a human body. [Figure 11] 11A-B are schematic illustrations of a transcatheter prosthetic tricuspid valve before and after compression according to an embodiment of the present invention. [Figure 12] FIG. 12 is a schematic diagram of a transportation system according to an embodiment of the present invention. [Figure 13] FIG. 13 is a schematic diagram of a transcatheter tricuspid valve anchor stent loading approach via the femoral vein and atrial septum according to an embodiment of the present invention. [Figure 14] 14A-D are schematic illustrations of a transcatheter tricuspid valve anchor stent approach via the femoral vein and atrial septum according to an embodiment of the present invention. [Figure 15] 15A-B are schematic diagrams illustrating a transcatheter approach to a tricuspid prosthetic valve via the femoral vein and atrial septum and delivery of an anchor stent according to an embodiment of the present invention. [Figure 16] 16A-C are schematic illustrations of a transcatheter tricuspid valve anchor stent approach via a combined route according to an embodiment of the present invention. [Figure 17] 17A-D are schematic illustrations of a transcatheter approach to a tricuspid prosthetic valve and delivery of an anchor stent via a combined route according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0016] The details of the present invention will become clear in conjunction with the drawings and the above-mentioned specific description of the present invention. However, the specific embodiments of the present invention described herein are merely for interpreting the purpose of the present invention and are not intended to limit the present invention in any manner. Under the teaching of the present invention, a person skilled in the art can conceive any possible modifications based on the present invention, and all of them should be considered to belong to the scope of the present invention.

[0017] The present invention relates to a separate, precisely anchored transcatheter tricuspid valve system, the system including a separate transcatheter tricuspid valve anchor stent (10) and a transcatheter biological tricuspid valve prosthesis (20), the shape and structure of the transcatheter tricuspid valve anchor stent matching the anatomy of the true tricuspid valve lesion after three-dimensional reconstruction based on patient image data, the transcatheter tricuspid valve anchor stent first delivered via a catheter to the patient's tricuspid valve lesion for release, deformation, and coaptation with the patient's supravalvular (40) and infravalvular (50) tissues, the transcatheter biological tricuspid valve prosthesis delivered via a catheter into the coapted transcatheter tricuspid valve anchor stent, and released, the transcatheter biological tricuspid valve prosthesis released, deformed, and expanded to a functional state, and the transcatheter tricuspid valve anchor stent is again deformed and expanded. Transcatheter prosthetic biological tricuspid valve At the same time, the transcatheter tricuspid valve anchor stent is deformed again to reconnect the anchor stent with the affected tricuspid valve and subvalvular tissue, thereby achieving the final anchor of the transcatheter biological tricuspid valve prosthesis. Because the true lesions of each patient are different, the transcatheter tricuspid valve anchor stents designed through three-dimensional reconstruction based on the patient's image data are not the same and must be adjusted according to the patient's true condition. As shown in Figures 3A-C, these are schematic diagrams of the combination of three separate anchor stents with different supravalvular and subvalvular structures with transcatheter biological tricuspid valve prostheses, but the general structure and configuration are all based on the same design concept and principles.

[0018] As shown in FIGS. 4 to 6, the transcatheter tricuspid valve anchor stent 10 according to the present application has a funnel-shaped umbrella stent structure in which the atrial surface is large and the ventricular surface is small. The stent includes an atrial surface 11, a ventricular surface 12, and a connecting portion 13 of the anchor stent between the atrial surface and the ventricular surface. The atrial surface is an umbrella cloth-like shape, i.e., a first lattice portion, that matches a true shape that is three-dimensionally reconstructed based on image data of the atrial surface of the patient. The ventricular surface 12 is an umbrella cloth-like shape that matches a true shape that is three-dimensionally reconstructed based on image data of the atrial surface of the patient, i.e., a first lattice portion. The ventricular surface 12 is an umbrella cloth-like shape that matches a true shape that is three-dimensionally reconstructed based on image data of the atrial surface of the patient. The anterior valve, the gate valve, and the posterior valve of the tricuspid valve of the patient are connected to each other. The anchor stent includes three positioning hook loops 121 precisely positioned at the boundary positions of the three valve leaflets, and multiple anchor hook loops 122 that match the true shape reconstructed three-dimensionally based on the subvalvular image data of the patient's affected tricuspid valve. The connecting portion 13 of the anchor stent has a round-mouthed funnel-like structure with a larger upper portion and a smaller lower portion between the atrial and ventricular surfaces. The length of the connecting portion matches the height of the corresponding transcatheter prosthetic tricuspid valve, and the anchor stent has a cylindrically expandable second lattice portion. As shown in Figures 4A-5C, the schematic diagrams of separate anchor stents for different supravalvular and subvalvular structures show the same overall structure, but the number, angles, and lengths of the atrial surface 11, positioning hook loops 121, and anchor hook loops 122 can be designed to match the anatomy of different patients. That is, the shape and size of the coverage area of ​​the transcatheter tricuspid valve anchor stent, as well as the shape, number, length, angle, and structural relationship of the ventricular surface and anchor hook loops of the anchor stent, are all three-dimensionally reconstructed (3mensio) based on the patient's individual preoperative CT image data, and the true structure of the patient's atrium (supravalvular) and ventricle (infravalvular) afterwards is compared with the true size and diameter-limiting structures measured with reference to the three-dimensional ultrasound images. Processing drawings for the transcatheter tricuspid valve anchor stent are then designed, and a unique, customized tricuspid valve anchor stent is finally manufactured by three-dimensional laser cutting and three-dimensional forming of a specific nickel-titanium memory alloy tube material.

[0019] Referring to Figures 7A-7C, an anchor stent and Transcatheter prosthetic biological tricuspid valveTo further strengthen the connection with the transcatheter tricuspid valve anchor stent, the ends of the connecting portion of the transcatheter tricuspid valve anchor stent on the atrial surface 11 are provided with a plurality of fixed support rods 111 for inserting the transcatheter tricuspid valve anchor stent, and the fixed support rods extend axially along the atrial surface, and then their ends are bent toward the axial center of the anchor stent. Alternatively, the connecting portion of the tricuspid valve anchor stent is provided with a plurality of end terminal centripetal hooks 112 for inserting the outflow end of the transcatheter tricuspid valve anchor stent, and similar centripetal hooks are also used on the atrial surface to replace the fixed support rods. In a first anchoring state of the transcatheter tricuspid valve anchor stent, the fixed support rods 111 maintain an angle consistent with the connecting portion of the anchor stent, and in a second anchoring state of the transcatheter tricuspid valve anchor stent, the fixed support rods 111 surround the axial center and become parallel to the axial direction, and the ends of the fixed support rods Transcatheter prosthetic biological tricuspid valve The inflow end of the stent is fitted to the Transcatheter prosthetic biological tricuspid valve The fixed support rods 111 are fixed to prevent displacement toward the atrial surface. The number of the fixed support rods 111 is 3 to 12.

[0020] The first and second lattice portions of the transcatheter tricuspid valve anchor bolt are formed by unit lattices consisting of compressible diamond lattices, V lattices, and / or hexagonal or polygonal lattices, and the first and second lattice portions are adaptively connected. The distance between the outer periphery of the lattice portion on the atrial surface of the transcatheter tricuspid valve anchor stent and the patient's atrial wall is 1 to 2 mm, preferably 1.5 mm. The diameter of the inner periphery of the second lattice portion of the transcatheter tricuspid valve anchor stent matches the outer diameter of various corresponding sizes of transcatheter prosthetic tricuspid valves. The surface of the transcatheter tricuspid valve anchor stent graft is coated with a single layer of medical polymer thin film. The connection portions of the atrial surface, ventricular surface, and anchor stent of the tricuspid valve anchor stent are three-dimensionally shaped structures after integral laser cutting or reconnected structures after separate processing of the connection portions of the atrial surface, ventricular surface, and anchor stent. The anchor stent is made of a metallic or non-metallic material having shape memory properties that allow it to recover its shape, such as a nickel-titanium alloy material.

[0021] According to the above-mentioned patient image real data, the tricuspid valve anchor stent is processed and manufactured in the pre-clamped state of the stent, i.e., the first anchored state after the stent is delivered to the lesion orifice position in the tricuspid valve via a catheter and released, as shown in Figures 8A-8B. In the second anchored state of the transcatheter tricuspid valve anchor stent: Transcatheter prosthetic biological tricuspid valve is delivered into the anchor stent via a catheter and expanded with the assistance of a balloon; Transcatheter prosthetic biological tricuspid valve Expanded (or nickel-titanium memory alloy) stents The tricuspid valve anchor stent is deformed from the first anchor state to the second anchor state, and the deforming force of the stent Transcatheter prosthetic biological tricuspid valve 9A-9B. At the same time, the anchor hook loops on the ventricular surface of the anchor stent, which are inserted into the subvalvular chordae and the subvalvular tissue, Transcatheter prosthetic biological tricuspid valveUnder the action of the external force of balloon expansion, as the anchor stent transforms from the first anchor state to the second anchor state, the anchor hook loops on the ventricular surface further bond with the chordae tendineae and subvalvular tissue 50 to achieve the final anchor, as shown in Figure 10. At the same time, in the first anchor state of the anchor stent, the fixed support rod or stent bend on the atrial side of its connecting structure wraps around the axis and becomes parallel to the axial direction as it transforms to the second anchor state, and the hooking force of the end of the fixed support rod or stent bend and the ventricular end of the stent at the connection part hooks onto the support rods on both ends of the transcatheter tricuspid valve stent. This automatic hooking structure between the anchor stent and both ends of the transcatheter tricuspid valve stent Transcatheter prosthetic biological tricuspid valve and the anchor stent are precisely combined and integrated. Transcatheter prosthetic biological tricuspid valve Ensure zero displacement, as shown in Figures 7A-7B.

[0022] The core of the present invention is as follows: (1) the design of a separate anchor stent; Transcatheter prosthetic biological tricuspid valve (2) Based on the image data of the supravalvular and subvalvular structures of the patient's preoperative tricuspid valve lesion, the anchor stent structure is individually designed and three-dimensionally fixed. (3) Using the boundaries of the valve leaflets, the dedicated positioning hook loop is used to accurately position the anchor stent, which has a similar shape to the atrial surface, and the subvalvular anchor hook loop structure is aligned and joined with the chordae tendineae and papillary muscles of the tricuspid valve leaflets. (4) After the anchor stent is released, the first anchor state (funnel-shaped) is used to determine the final anchor principle and location, i.e., the preset transitional state of the second anchor state (cylindrical), based on the patient's true pathological anatomical structure, and the personalized pathological anatomical structure is aligned. Transcatheter prosthetic biological tricuspid valve The deforming force released by the balloon expansion causes the anchor stent to deform into a cylindrical second anchor state, thereby Transcatheter prosthetic biological tricuspid valveThe anchor stent and the stent are transformed into a second anchor state together in the heart, thereby achieving supravalvular and subvalvular clamping, thereby clamping the subvalvular tissue again between the anchor stent and the ventricular wall, and completing the final anchor. (5) The anchor stent transforms from the first state to the second state, and this transformation process is Transcatheter prosthetic biological tricuspid valve and realizes automatic coupling with Transcatheter prosthetic biological tricuspid valve The discharge operation can be realized automatically and accurately.

[0023] The transcatheter prosthetic tricuspid valve according to the present invention has an anchor stent attached thereto, and its structure serves only to rationally support the three valve leaflets. The stent includes a cobalt-chromium alloy stent that is radially compressed and assumes a cylindrical or incomplete cylindrical shape after being expanded by a balloon, or a nickel-titanium alloy stent that is radially compressed and self-expanding, and three fan-shaped valve leaflets provided inside the stent. Each of the fan-shaped valve leaflets has a free edge, an arc-shaped base, and leaflet boundary connections extending on both sides. The stent can be grasped in various forms, such as a metal net tube or a stent that can support and fix the boundaries of the three valve leaflets. stents is. stents is a cobalt-based alloy, a cobalt or chromium alloy, or a nickel titanium alloy. See Figures 11A-11B.

[0024] The tricuspid valve system of the present application further includes a delivery assembly 30, which includes a transcatheter tricuspid valve anchor stent delivery kit and a transcatheter bioprosthetic tricuspid valve delivery kit, the transcatheter tricuspid valve anchor stent delivery kit including a delivery catheter 31 and a transcatheter tricuspid valve anchor stent loader 32. The transcatheter bioprosthetic tricuspid valve delivery kit includes a transcatheter bioprosthetic tricuspid valve delivery device, a guide sheath, a leaflet gripper, and a charge pump. The transcatheter tricuspid valve anchor stent delivery device and the transcatheter bioprosthetic tricuspid valve delivery device can be approached via the femoral vein, atrial septum, apical puncture, or left atrial puncture. These techniques are similar to those of the prior art.

[0025] When performing transcatheter therapy using the transcatheter tricuspid valve system of the present invention, an approach is made from the inferior vena cava via the femoral vein or from the superior vena cava via the jugular vein or subclavian vein.

[0026] Figures 13-15 are approached from the inferior vena cava via the femoral vein.

[0027] Approaching the inferior vena cava via the femoral vein is the most commonly used and most convenient approach. The loaded anchor stent is transported from the inferior vena cava via the femoral vein into the patient's affected tricuspid valve in the right atrium (Figure 14A). The positioning hook loop is released to complete the positioning (Figure 14B). The ventricular surface of the anchor stent (Figure 14C), the stent's connecting structure, and the atrial surface are sequentially released, aligning and connecting the anchor hook loops on the ventricular surface, i.e., the first anchor state of the anchor stent (Figure 14D). The anchor stent transport device is then removed, and the loaded stent is returned along its original route. Transcatheter prosthetic biological tricuspid valve The stent was then delivered into the anchor stent (Fig. 15A), and then balloon-assisted Transcatheter prosthetic biological tricuspid valve and expanding the anchor stent to transform the anchor stent into a second anchor state. Transcatheter prosthetic biological tricuspid valve This achieves precise connection with the valve, while simultaneously forming a clamp with the subvalvular tissue, completing the final anchor (Figure 15B).

[0028] The present transcatheter tricuspid valve system also has a jugular approach route, which is shown in Figures 16-17.

[0029] The loaded anchor stent is transported via the jugular vein from the superior vena cava to the right atrium of the patient in the affected tricuspid valve, and the following procedure is similar (Figures 16-17).

[0030] The above examples are merely intended to fully illustrate the embodiments of the specifications set forth by the present invention. The transcatheter tricuspid valve system of the present invention has already implemented the above technical solutions through industrial animal experiments and has been confirmed by those skilled in the art.

[0031] The feasible significance of this invention is as follows: (1) The separate design functionally separates valve leaflet support from valve leaflet anchoring. By transferring the valve leaflet anchor at the tricuspid valve position to the anchor stent, personalized anchor design is possible. At the same time, transcatheter anchor stent and transcatheter valve leaflet delivery can be implemented in stages, preventing complex structures and excessive volume after compression that would make delivery via catheter difficult. (2) The anchor principle and final anchor site are pre-designed and measured based on the anatomical characteristics of the affected valve leaflet, and the second anchor state of the anchor stent is determined. The anchor stent is constructed using personalized patient cinemetric data, dedicated software, and 3D printing tests, and the size and dimensions of each site are three-dimensionally shaped and processed to a preset transitional state, i.e., the first anchor state. After delivery via catheter, it is accurately aligned, providing support for smooth transcatheter valve leaflet delivery. The gradient structure of the anchor stent in the first state allows for a moderately large opening and can also prevent severe regurgitation. The former not only provides a channel for the transcatheter valve, but also prevents the sudden expansion of stenotic lesions; the latter reduces the massive reflux of valvular insufficiency, Transcatheter prosthetic bioprosthetic tricuspid valve is inserted (3) The external force released from the valve leaflet drives the anchor stent to deform from the funnel-shaped first anchor state to the cylindrical second state, and this deformation allows the anchor stent to firmly grip the valve leaflet toward the axis, ensuring zero displacement of the valve leaflet when mated with the transcatheter valve leaflet, and the anchor hook-and-loop structure on the ventricular surface further binds tightly to the subvalvular tissue, completing the pre-designed alignment anchor and forming a clamp with the structure on the valve to achieve the final anchor. (4) The support rod structure arranged transcatheter between the inflow end and outflow end of the connection part of the transcatheter tricuspid valve anchor stent is supported from both ends. Transcatheter prosthetic biological tricuspid valve(5) With the above-described separate, precise anchor transcatheter tricuspid valve system, each time a precise transcatheter treatment procedure for a specific, individual tricuspid valve is completed, the relevant data analysis, related data acquired during the entire process of the transcatheter tricuspid valve anchor stent configuration design, processing and manufacturing, and transcatheter treatment, as well as postoperative progress data, are stored as an independent data unit, including a large amount of relevant data such as individual image data, anchor stent design and processing parameters, transcatheter treatment process, and postoperative results, thereby realizing intelligent, commercial, and large-scale transcatheter treatment using the separate, precise anchor transcatheter tricuspid valve system.

Claims

1. a separate transcatheter tricuspid valve anchor stent and a transcatheter biological tricuspid valve prosthesis; The shape and structure of the transcatheter tricuspid valve anchor stent are matched with a true structure of the tricuspid valve three-dimensionally reconstructed based on the patient's image data, and the transcatheter tricuspid valve anchor stent is first delivered to the patient's tricuspid valve location for release, deformation, and individual alignment and coaptation with supravalvular and subvalvular tissues at the patient's tricuspid valve location; The transcatheter biological tricuspid valve prosthesis is delivered into the transcatheter tricuspid valve anchor stent and released, the transcatheter biological tricuspid valve prosthesis is released, deformed, and expanded to a functional state, and the transcatheter tricuspid valve anchor stent is again deformed to couple with the expanded transcatheter biological tricuspid valve prosthesis, and at the same time, the transcatheter tricuspid valve anchor stent is again deformed to complete the preset coupling between the anchor stent and the subvalvular tissue and anchor it. A separate, precisely anchored transcatheter tricuspid valve system.

2. The tricuspid valve system further includes a delivery assembly, the delivery assembly including a transcatheter tricuspid valve anchor stent delivery kit and a transcatheter tricuspid valve prosthetic delivery kit, the transcatheter tricuspid valve anchor stent delivery kit including a delivery catheter, a transcatheter tricuspid valve anchor stent delivery device, and a stent loader.

10. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1.

3. The separate transcatheter tricuspid valve anchor stent and the transcatheter biological tricuspid valve prosthesis are reintegrated in the body after being approached back and forth, and at the same time, the transcatheter tricuspid valve anchor stent is deformed again to complete the preset connection with the patient's diseased tricuspid valve and subvalvular tissue, thereby realizing the anchoring of the transcatheter biological tricuspid valve prosthesis, thereby replacing the diseased tricuspid valve in situ.

3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or claim 2.

4. the transcatheter tricuspid valve anchor stent has a compressed state disposed within a catheter, a first anchored state after being released through the catheter, and a second anchored state after being coupled to a transcatheter tricuspid valve prosthesis; In the first anchored state, the tricuspid valve anchor stent is transformed after being released through the catheter into a uniquely aligned engagement and clamping engagement with supravalvular and subvalvular tissues at the tricuspid valve location of the patient; In the second anchoring state, the transcatheter biological tricuspid valve prosthesis is delivered by a catheter into the anchor stent of the transcatheter tricuspid valve in the first state, and is expanded and secondary deformed by the external force of the balloon expansion, and is integrally coupled with the expanded transcatheter biological tricuspid valve prosthesis, and at the same time, the anchor stent completes the predetermined coupling between the leaflet or subvalvular tissue at the tricuspid valve position of the patient, thereby anchoring the valve.

3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or claim 2.

5. In the first anchoring state, the transcatheter tricuspid valve anchor stent is processed into a funnel shape with a large atrial surface and a small ventricular surface, and the transcatheter tricuspid valve anchor stent is delivered through a catheter and released, and then deforms and recovers its shape, accurately corresponding to the patient's dynamic lesion of the tricuspid valve supravalvular and subvalvular tissues, thereby achieving individualized alignment, coaptation, and clamping; In the second fixed state, the transcatheter tricuspid valve anchor stent in the first anchor state and the transcatheter biological tricuspid valve delivered into the stent via the catheter are expanded by a balloon to be integrated, and the transcatheter tricuspid valve anchor stent is clamped by the shape recovery to the axis due to the secondary deformation from the original funnel shape to a cylindrical shape, and is coupled with the transcatheter biological tricuspid valve, and at the same time, completes the preset tight coupling with the patient's tricuspid valve position and subvalvular tissue.

5. The separate, precisely anchorable transcatheter tricuspid valve system of claim 4.

6. The three-dimensionally reconstructed true structure is a digital image model or a 3D printing simulation solid model, and the three-dimensionally reconstructed true structure is a virtual simulation three-dimensional image after digitizing and converting the integrated image of CT, ultrasound and nuclear magnetism and a corresponding 3D printing simulation solid model; 3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or claim 2.

7. The transcatheter tricuspid valve anchor stent has an umbrella-type stent structure, and includes an atrial surface, a ventricular surface, and an anchor stent connection portion therebetween. The atrial surface is an umbrella cloth-like structure, i.e., a first lattice portion, which matches the true individual shape three-dimensionally reconstructed based on image data of the atrial surface of the patient. The ventricular surface is three positioning hooks and loops accurately preset at the boundary positions of the three leaflets of the anterior, posterior, and posterior tricuspid valve of the patient. The anchor stent connection portion is a round-mouthed funnel-like structure whose circular diameter is the inner diameter of the annulus of the patient's tricuspid valve and the outer diameter of the subsequent transcatheter prosthetic tricuspid valve. At the bottom end of the funnel, a second lattice portion is opened, which matches the shape and degree of stenosis and / or regurgitation of the tricuspid valve leaflets.

3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or 2.

8. The first anchor state of the connection part of the transcatheter tricuspid valve anchor stent is a three-dimensional fixed shape memory state of the true anatomical form and structure of the individual corresponding patient after being delivered and released through a catheter, and the fixed shape memory state of the connection part from the atrial surface to the ventricular surface has a contraction gradient, the gradient being 5 to 45 degrees, which is determined according to the morphology of the patient's diseased valve leaflets, and the connection part of the anchor stent is transformed from a conical funnel shape of the first anchor state to a cylindrical second anchor state through deformation and expansion.

8. The separate, precisely anchorable transcatheter tricuspid valve system of claim 7.

9. In the first anchoring state of the transcatheter tricuspid valve anchor stent, the positioning hook loop is released through the catheter and then inserted into the boundary positions of the anterior, posterior and posterior leaflets of the tricuspid valve of the patient's lesion, so as to achieve a personalized correspondence between the atrial surface of the anchor stent and the shape of the patient's right atrium, and to position and deploy it.

9. The separate, precisely anchorable transcatheter tricuspid valve system of claim 8.

10. The ventricular surface of the tricuspid valve anchor stent has a plurality of anchor hook loops, which extend from the connection portion to the right ventricular surface and then turn back, and the number of the anchor hook loops accurately matches the number of true chordae tendineae and the morphology of the subvalvular tissue structure three-dimensionally reconstructed based on the subvalvular image data of the patient's tricuspid valve lesion.

8. The separate, precisely anchorable transcatheter tricuspid valve system of claim 7.

11. The number, size, shape and folding angle of the anchor hook loops are individually and accurately matched to the true chordae tendineae gap, the size and shape of the tricuspid valve leaflets and the circumferential distance between the perivalvular tissue and the ventricular wall, which are three-dimensionally reconstructed based on the subvalvular image data of the patient's affected tricuspid valve.

11. The separate, precisely anchorable transcatheter tricuspid valve system of claim 10.

12. In a first anchoring state of the tricuspid valve anchor stent, the anchor hook loops are released through a catheter, positioned at gaps between the patient's chordae tendineae, and joined together in a predetermined number; in a second anchoring state of the tricuspid valve anchor stent, the plurality of anchor hook loops form a clamping portion by recovering their shape after release and by the action of a resultant force with the atrial surface and connecting portion of the tricuspid valve anchor stent, and the plurality of deformed anchor hook loops are tightly joined to the patient's diseased tricuspid valve leaflets, subvalvular chordae tendineae, and subvalvular tissue by a preset intertwining.

11. The separate, precisely anchorable transcatheter tricuspid valve system of claim 10.

13. The anchor hook loops are divided into three groups corresponding to the three valve leaflets, and the number of each group is 3 to 9, corresponding to the number of chordae and chordae gaps of the patient.

11. The separate, precisely anchorable transcatheter tricuspid valve system of claim 10.

14. a plurality of fixed support rods for inserting the transcatheter tricuspid valve stent are provided at the end of the atrial surface of the connecting portion of the transcatheter tricuspid valve anchor stent, and the fixed support rods extend along the axial direction of the atrial surface, and then the end portions are bent toward the axial center of the anchor stent; 8. The separate, precisely anchorable transcatheter tricuspid valve system of claim 7.

15. The connecting portion of the tricuspid valve anchor stent is provided with a plurality of terminal centripetal hooks for inserting the outflow end of the transcatheter tricuspid valve stent, and a plurality of fixed support rods for inserting the atrial end of the transcatheter tricuspid valve stent are arranged at the end of the atrial surface between these centripetal hooks and the connecting portion of the tricuspid valve anchor stent, surrounding them from above and below, and preventing the transcatheter prosthetic tricuspid valve from moving toward the ventricle when released.

15. The separate, precisely anchorable transcatheter tricuspid valve system of claim 14.

16. In a first anchoring state of the transcatheter tricuspid valve anchor stent, the fixed support rods maintain an angle consistent with the anchor stent connection portion; in a second anchoring state of the transcatheter tricuspid valve anchor stent, the multiple fixed support rods are circumferentially arranged toward the axis and parallel to the axial direction, with the ends of the fixed support rods fitted into the stent at the inflow end of the transcatheter tricuspid valve, structurally and firmly integrated with the transcatheter tricuspid prosthetic valve, realizing zero displacement during release of the transcatheter tricuspid prosthetic valve.

15. The separate, precisely anchorable transcatheter tricuspid valve system of claim 14.

17. The number of the fixed support rods is 3 to 12.

15. The separate, precisely anchorable transcatheter tricuspid valve system of claim 14.

18. The first lattice portion and the second lattice portion of the transcatheter tricuspid valve anchor bolt are formed by unit lattices of compressible diamond lattices, V lattices, and / or hexagonal or polygonal lattices, and the first lattice portion and the second lattice portion are adaptively connected.

8. The separate, precisely anchorable transcatheter tricuspid valve system of claim 7.

19. The distance between the outer periphery of the lattice portion of the atrial surface of the transcatheter tricuspid valve anchor stent and the atrial wall of the patient is 1 to 2 mm.

8. The separate, precisely anchorable transcatheter tricuspid valve system of claim 7.

20. The diameter of the inner periphery of the second lattice portion of the transcatheter tricuspid valve anchor stent matches the outer diameter of various corresponding sizes of transcatheter prosthetic biological tricuspid valves.

8. The separate, precisely anchorable transcatheter tricuspid valve system of claim 7.

21. A part or the whole of the surface of the transcatheter tricuspid valve anchor stent is coated with a thin film of medical polymer; 3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or claim 2.

22. The connection portions of the atrial surface, the ventricular surface, and the anchor stent of the tricuspid valve anchor stent are three-dimensionally formed structures after laser integral cutting or reconnected structures after separate processing of the connection portions of the atrial surface, the ventricular surface, and the anchor stent.

3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or claim 2.

23. The anchor stent is a metal or non-metal material having shape memory properties that allow it to recover its shape.

3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or claim 2.

24. The anchor stent is made of a nickel-titanium alloy material; 3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or claim 2.

25. The transcatheter prosthetic tricuspid valve includes a cobalt-chromium alloy stent that assumes a cylindrical or partially cylindrical shape after being radially compressed and expanded by a balloon, or a nickel-titanium alloy stent that self-expands when radially compressed, and three fan-shaped leaflets provided inside the stent, each of which has a free edge, an arc-shaped base, and leaflet boundary connections extending on both sides, and the stent can be a metal net tube or a stent that can be grasped in various forms that can support and fix the boundaries of the three leaflets.

3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or claim 2.

26. The stent is a cobalt-based alloy, a cobalt or chromium alloy, or a nickel titanium alloy.

26. The separate, precisely anchorable transcatheter tricuspid valve system of claim 25.

27. The transcatheter prosthetic tricuspid valve delivery kit includes a transcatheter prosthetic tricuspid valve delivery device, a guide sheath, a leaflet gripper, and a charge pump.

3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 2.

28. The transcatheter tricuspid valve anchor stent delivery device and the transcatheter tricuspid valve prosthetic delivery device can be delivered to the tricuspid valve location from the inferior vena cava via the femoral vein or from the superior vena cava via the jugular or subclavian vein.

28. The separate, precisely anchorable transcatheter tricuspid valve system of claim 27.

29. The transcatheter tricuspid valve anchor stent is first approached to the tricuspid valve position of the patient's lesion through a catheter and released into a first anchor state; then, the transcatheter biological tricuspid valve prosthesis is delivered through a catheter into the anchor stent; while the transcatheter biological tricuspid valve prosthesis is expanding, the transcatheter tricuspid valve anchor stent is expanded into a second anchor state; and at the same time, the connection part of the stent and the transcatheter biological tricuspid valve prosthesis are fitted together, completing a tighter connection between the ventricular surface of the stent and the valve substructure to form a final anchor.

26. The separate, precisely anchorable transcatheter tricuspid valve system of claim 25.

30. Each time a treatment process for a transcatheter prosthetic tricuspid valve that achieves precise anchoring according to the individual preset settings of a specific patient is completed, all relevant data of the personalized transcatheter tricuspid valve system are stored as an independent data unit, and a large amount of personalized data is accumulated. Through artificial intelligence, the separate, precise anchoring transcatheter tricuspid valve system is realized to be intelligent, large-scaled, and industrialized.

3. The separate, precisely anchorable transcatheter tricuspid valve system of claim 1 or 2.

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