A transcatheter mitral valve system with separate components for precise anchoring.
The transcatheter mitral valve system with separate anchor stent and artificial body components addresses the complexity of mitral valve anatomy by using patient-specific design and shape memory alloys for precise anchoring and integration, enhancing treatment efficacy and scalability.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- BEIJING BALANCE MEDICAL
- Filing Date
- 2022-11-17
- Publication Date
- 2026-07-02
Smart Images
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Abstract
Description
Technical Field
[0001] The present invention relates to an artificial biological heart valve, and particularly to a transcatheter Mitral valve system capable of a separate and accurate anchor.
Background Art
[0002] According to the "China Cardiovascular Diseases Report 2019", the number of patients with heart valve diseases in the whole country reached 36.3 million in 2019. Among them, Mitral valve patients with valvular diseases are the largest group in cardiac valve surgery. Mitral valve Only mitral regurgitation (MR) accounts for 29.2%, and the number of MR patients reached about 10 million. The severe Mitral valve regurgitation patients who need surgery reached about 2 million. Among them, 40% of the patients are elderly, with poor cardiac function, and have complications and multiple organ dysfunction and cannot withstand surgery. About 800,000 severe Mitral valve regurgitation patients Mitral valve have no choice but to rely on transcatheter treatment.
[0003] The clinical application and products of transcatheter aortic valves have become increasingly mature with improvement. Because of the advantages of being minimally invasive, not requiring extracorporeal circulation, and having appropriate short-term and mid-term effects, it has already been recognized as an effective treatment means for the elderly or high-risk patients with traditional surgical aortic valve replacement. However, the mitral valve, as an intracardiac valve on the left side, has an asymmetric saddle-shaped mitral valve ring , a leaflet structure with diverse shapes and lesions (such as mitral stenosis or mitral regurgitation and both), a complex subvalvular tissue (including chordae tendineae and papillary muscles), an adjacent left ventricular outflow tract, and the valve ringDue to the significant supravalvular and subvalvular deformations, and the complexity of these anatomical forms and structures, it is virtually impossible to design transcatheter mitral valves by applying the concept of supporting the supravalvular shape and / or circumferential radial direction, as is done with transcatheter aortic valves. Therefore, transcatheter mitral valves have lagged behind transcatheter aortic valves in research and development for nearly a decade and need to be updated in terms of product structure and anchoring principle design philosophy.
[0004] As reported in the literature, various types of transcatheter Mitral valve There are approximately 20 types of product research and development projects, and as shown in Figure 1, nine of them are being tested for implantation in humans, while as shown in Figure 2, research and development projects for four types have currently been suspended. Abbott, Medtronic, and Edwards Lifesciences are among the transcatheter devices currently under development. Mitral valve Aside from the products (Figures 3A-D) that we continuously report, we also report on other transcatheter catheters. Mitral valve Research on transcatheter-based methods has very few clinical studies. Mitral valve Industrial development is currently in a bottleneck phase that requires a breakthrough. Mitral valve In the patents published for the product and existing similar products, the design concept and structural features all involve the implantation of a disposable catheter and an integrated valve structure, therefore Mitral valve It is difficult to satisfy the unique and complex environment of the lesions. [Overview of the project]
[0005] This invention is a solution for all conventional transcatheters. Mitral valve Contrary to the product's design philosophy, it is a separate diameter catheter. Mitral valve We provide system design. A separate component means the product is transcatheter-type. Mitral valve Anchor stents and transcatheter artificial bodies Mitral valve It consists of two parts, the former first via the catheter Mitral valve It is transported to a location and released, and consequently the latter is approached and the former Mitral valveThis means that the balloon is deformed by the external force assisted by its expansion, integrates with the lesion's valve location, and thereby primarily achieves anchoring by the lesion's valve tissue itself.
[0006] The transcatheter of the present invention Mitral valve The system is compatible with all previously published transcatheter catheters. Mitral valve Unlike the product's structure, a single transcatheter Mitral valve Anchor stent and one transcatheter artificial body Mitral valve It consists of two parts, and the core point of the invention is that the transcatheter anchoring of the valve and the support of the valve leaflet are separated into two independent structures, that is, separate parts Mitral valve The anchor stent Transcatheter artificial mitral valve He was in charge of anchoring, transcatheter artificial body Mitral valve It is similar to the valve in a transcatheter valve. Anchor stent Transported inside and released, then deformed again anchor Artificially attached to a stent Bio-mitral valve The goal is to achieve transcatheterization.
[0007] The transcatheter of the present invention Mitral valve The system is separate Mitral valve Transcatheter artificial body capable of precise anchoring with a separate anchor stent. Mitral valve It includes the configuration of two parts. One of the gist of the present invention is the transcatheter Mitral valve The anchor stent has two different anchoring states with different shapes and structures, namely, the first anchoring state after being released via catheter, and the transcatheter Mitral valve It has a second anchor state after being coupled to it.
[0008] The first anchor state described above was reconstructed three-dimensionally based on the patient's unique image data. Mitral valve Formulated and designed based on the true structure and morphology, manufactured by external three-dimensional molding, and deformation after discharge via the catheter is controlled by the patient. Mitral valve It can be precisely positioned and joined to the supraval and subvalvular tissues, and the transcatheter Mitral valve The anchor stent exhibits a funnel shape from the atrial to the ventricular surface, deforming and recovering its shape after release to accommodate the patient's dynamic lesion. Mitral valve The transcatheter is precisely positioned in relation to the supravalvular and subvalvular tissues and grasped by them. Mitral valve How to process and shape the first anchor state of the anchor stent via transcatheter Mitral valve The anchor stent and the patient Mitral valve It depends on how accurately the degree of matching with the true anatomical structure is achieved. The three-dimensionally reconstructed true structure is a digital image model or a 3D printed simulation physical model, and the three-dimensionally reconstructed true structure is a three-dimensional image of a virtual simulation after digitizing integrated CT, ultrasound, and nuclear magnetic images and a corresponding 3D printed simulation physical model.
[0009] The first anchor state of the transcatheter mitral valve anchor stent is, as described above, the true anatomical form of the patient's mitral valve reconstructed in three dimensions, and the specific design and fabrication consists of an umbrella-shaped stent structure, i.e., an atrial surface, a ventricular surface, and the connection part of the anchor stent between the two. (1) The atrial surface is umbrella-shaped and has an umbrella-like shape that conforms to the true form reconstructed in three dimensions based on the patient's atrial surface image data, and is the first lattice portion, and after discharge, the mitral valve at the bottom of the left atrium valve ringThe (2) ventricular surface is precisely positioned in the upper part, and the (3) anchor stent connection is round-mouthed funnel-shaped and is a second lattice portion. What has been described so far is the state of the stent after the transcatheter mitral valve anchor stent has been fully released within the catheter and detached from the catheter. The first anchor state of the connection of the transcatheter mitral valve anchor stent is a three-dimensional fixed memory state of the true anatomical form and structure of the individual corresponding patient after being transported and released through the catheter, and the fixed memory state of the connection from the atrial surface to the ventricular surface has a contraction gradient that matches from the valve orifice to the subvalvular part, the gradient is 5 to 45 degrees, which is determined according to the morphology of the valve leaf of the patient's lesion, and the anchor stent connection deforms from the round-mouthed funnel shape of the first anchor state to a cylindrical fixed second anchor state by deformation and expansion. In the first anchoring state of the transcatheter mitral valve anchor stent, the positioning hook loop is released through the catheter and then precisely inserted into the boundary position of the two anterior and posterior lobes of the mitral valve in the patient's lesion, thereby achieving a personalized correspondence between the atrial surface of the anchor stent and the morphology of the patient's left atrium, and positioning and laying the stent. The ventricular surface of the mitral valve anchor stent has multiple anchor hook loops that extend from the connection point to the ventricular surface and are folded back, and are precisely matched to the number, size, morphology, and fold of the true chordae tendineae and subvalvular tissue structures, which are three-dimensionally reconstructed based on subvalvular imaging data of the patient's lesion mitral valve. The number, size, morphology, and folding angle of the anchor hook loops are uniquely and precisely matched to the true chordae tendineae gaps, the size and shape of the mitral valve lobes, and the circumferential spacing between the perivalvular tissue and the ventricular wall, which are three-dimensionally reconstructed based on subvalvular imaging data of the patient's lesion mitral valve.
[0010] The transcatheter Mitral valve The second anchoring state of the anchor stent is, in the first anchoring state, transcatheter artificial biopsy Mitral valve In the first state, transcatheter via catheter Mitral valveIt is sent into the anchor stent, and then, due to the external force caused by balloon expansion, it undergoes secondary deformation as the balloon expansion valve expands, changing from the original conical funnel shape of the first anchor state to the expanded trans-catheter artificial Mitral valve which is integrally coupled to form a final cylindrical shape, and at the same time, the trans-catheter Mitral valve The structure of the ventricular surface of the anchor stent of the and the Mitral valve realizes the anchor by the final connection with the chordae tendineae and papillary muscles of the patient, that is, the trans-catheter Mitral valve This means the second anchor state of the anchor stent of the.
[0011] The trans-catheter Mitral valve The second anchor state of the anchor stent of mainly depends on the patient's individual Mitral valve Based on the three-dimensionally reconstructed ultrasonic image of the, the Mitral valve morphology of the valve leaflets, the size of the valve leaflet surface area, and the true anatomical structure of the chordae tendineae and papillary muscles in the two valve leaflets. Based on these, the Mitral valve morphology, size, and bending angle of the anchor hook loops on the ventricular surface of the anchor stent of the trans-catheter are designed and processed. By inserting the trans-catheter artificial Mitral valve in a compressed state and expanding it by pressurizing a pressure pump, in such a case, through several anchor hook loops such as those with matching morphology and structure, it is deformed to align with the preset final anchor state, achieving the final accurate and tight connection with the Mitral valve position of the patient and the sub-valvular tissue.
[0012] The trans-catheter Mitral valve The anchor stent of is in a compressed state arranged inside the catheter. After being released through the catheter, it becomes the first anchor state, and further Transcatheter artificial mitral valve couples with to convert to the second anchor state. It is a plurality of anchor hook loops provided based on the true anatomical morphology of the Mitral valve patient three-dimensionally reconstructed based on the patient's individual image data by the connection part of the anchor stent. After being released through the catheter, Mitral valveThe anchor hook loop is precisely inserted into the two boundaries of the anterior and posterior valves to achieve the positioning of the entire anchor stent. Mitral valve The morphology of the atrial surface of the anchor stent and the morphology of the patient's left atrium are positioned to match the range of left atrial contraction expansion during the cardiac cycle, as well as the transcatheter Mitral valve The anchor hook loop on the ventricular side of the anchor stent is located in the patient's lesion. Mitral valve Positioned to be inserted and clamped in the chordal space of the valve leaflet, transcatheter Mitral valve When the anchor stent is converted to a second anchor state, these anchor hook loops can achieve precise confluence with the subvalvular tissue and tight, pre-configured coupling.
[0013] The transcatheter Mitral valve The anchor stent has a first anchor state after being released through the catheter, and then, Transcatheter artificial mitral valve It combines with the transcatheter and deforms into a second anchor state, Mitral valve The atrial surface end of the anchor stent connection is transcatheter Mitral valve of stent Multiple fixing support rods are provided for insertion, and the fixing support rods extend axially along the atrial plane, and then their ends are bent toward the axis of the anchor stent. Mitral valve The connection point of the anchor stent is transcatheter Mitral valve Multiple terminal centripetal hooks are provided for inserting the outflow end of the stent, and these centripetal hooks and the Mitral valve The atrial surface end of the anchor stent connection is transcatheter Mitral valve Multiple fixing support rods are positioned above and below to surround the atrial end of the stent for insertion. Transcatheter artificial mitral valve This prevents displacement toward the ventricular side during discharge. Mitral valve In the first anchoring state of the anchor stent, the fixing support rod maintains an angle that coincides with the connection portion of the anchor stent, Mitral valveIn the second anchoring state of the anchor stent, the plurality of fixing support rods surround the axis, are parallel to the axial direction, and the ends of the fixing support rods are Transcatheter artificial mitral valve It is fitted into the stent at the inlet end, Transcatheter artificial mitral valve Ensure zero displacement during release.
[0014] The transcatheter Mitral valve The first and second lattice portions of the anchor bolt are formed by unit lattices consisting of compressible rhombic lattices, V-lattices, and / or hexagonal or polygonal lattices, and the first and second lattice portions are adaptively connected.
[0015] The transcatheter Mitral valve The distance between the outer edge of the lattice portion on the atrial surface of the anchor stent and the patient's atrial wall is 1 to 2 mm, preferably 1.5 mm. Mitral valve The diameter of the inner periphery of the second lattice portion of the anchor stent is the diameter of the transcatheter artificial body. Mitral valve It matches the outer diameter of various corresponding size standards. The transcatheter Mitral valve The surface of the anchor stent is coated with a thin film of medical polymer. Mitral valve The atrial surface, ventricular surface, and connection portion of the anchor stent are either a three-dimensional molded structure after laser integral cutting or a reconnected structure after separate processing of the atrial surface, ventricular surface, and connection portion of the anchor stent. The anchor stent is made of a metallic or non-metallic material with shape memory properties that allow for shape recovery. The anchor stent is made of a nickel-titanium alloy. Transcatheter artificial body Mitral valveThe stent comprises a cobalt-chromium alloy stent that is cylindrical or partially cylindrical after being compressed radially and expanded by a balloon, or a nickel-titanium alloy stent that is self-expanding when compressed radially, and three fan-shaped lobes provided inside the stent, each of which has a free edge, an arc-shaped base, and lobe boundary connectors extending on both sides, and the stent is graspable in various forms that can support and fix a metal net tube or the boundaries of the three pairs of lobes. stent That is the case. stent The cobalt-based alloy is a cobalt-chromium alloy or a nickel-titanium alloy. Mitral valve The transport kit is for transcatheter artificial biopsies. Mitral valve The transcatheter includes a transport device, a guide sheath, a valve gripper, and a charge pump. Mitral valve Transport equipment for anchor stents and transcatheter artificial bodies Mitral valve The transport device can be accessed via femoral vein interatrial septum, apical puncture, or left atrial puncture. Mitral valve The anchor stent first... Mitral valve Precise anchoring is performed using a separate system to the position, and the material is released to the first anchored state. Subsequently, transcatheter artificial body is introduced via a catheter. Mitral valve The anchor stent is then fed in, Transcatheter artificial mitral valve As it expands, the transcatheter Mitral valve The anchor stent is extended to a second anchor state, and finally the stent connection and Transcatheter artificial mitral valve The stent is then fitted together, completing a tighter connection between the ventricular surface of the stent and the valve substructure, thus forming the final anchor. This ensures precise anchoring for each specific patient's individual pre-configuration. Transcatheter artificial mitral valve Each time the treatment process is completed, all the above related data is accumulated as an independent data unit, and artificial intelligence enables precise anchoring of the transcatheter. Mitral valve To enable intelligent, large-scale, and industrialized systems. [Brief explanation of the drawing]
[0016] [Figure 1] Figure 1 shows actual diagrams of various types of transcatheter-assisted mitral valves from 2012 to 2019. [Figure 2] Figure 2 is a diagram of a transcatheter-induced artificial mitral valve implanted in the human body using conventional technology. [Figure 3] Figures 3A-C show actual diagrams of the transcatheter artificial mitral valve, which is still under development. [Figure 4] Figures 4A-D are schematic diagrams illustrating the combination of separate anchor stents with different upper and lower valve structures according to embodiments of the present invention and a transcatheter artificial bioprosthetic mitral valve. [Figure 5] Figures 5A-D are schematic diagrams of separate anchor stents with different upper and lower valve structures according to embodiments of the present invention. [Figure 6] Figure 6 is a schematic diagram of the atrial surface of a separate anchor stent according to an embodiment of the present invention. [Figure 7] Figure 7 is a schematic diagram of the connection between the ventricular surface of a separate-type anchor stent according to an embodiment of the present invention and the anchor stent. [Figure 8] Figures 8A-C are schematic diagrams of the fixing support rod and centered bending of a separate-type anchor stent according to an embodiment of the present invention. [Figure 9] Figures 9A-C are schematic diagrams of the first anchor state after an anchor stent for a transcatheter mitral valve according to an embodiment of the present invention has been implanted in the human body. [Figure 10] Figures 10A-C are schematic diagrams of the second anchor state after an anchor stent for a transcatheter mitral valve according to an embodiment of the present invention has been implanted in the human body. [Figure 11] Figure 11 is a schematic diagram of the anchor hook loop and secondary anchor of the chordae tendineae after an anchor stent for a transcatheter mitral valve according to an embodiment of the present invention has been implanted in the human body. [Figure 12] Figures 12A-B are schematic diagrams of a transcatheter artificial bioprosthetic mitral valve before and after compression according to an embodiment of the present invention. [Figure 13] Figure 13 is a schematic diagram of a transport system according to an embodiment of the present invention. [Figure 14] Figure 14 is a schematic diagram of loading a transcatheter mitral valve anchor stent via an apical approach according to an embodiment of the present invention. [Figure 15] Figures 15A-E are schematic diagrams illustrating the process of approaching a transcatheter mitral valve anchor stent via an apical approach according to an embodiment of the present invention. [Figure 16] Figures 16A-B are schematic diagrams illustrating the process of approaching the mitral valve via an apical approach according to an embodiment of the present invention and delivering it to an anchor stent. [Figure 17] Figure 17 is a schematic diagram of loading a transcatheter mitral valve anchor stent via the femoral vein interatrial septum according to an embodiment of the present invention. [Figure 18] Figures 18A-D are schematic diagrams illustrating the process of approaching a transcatheter mitral valve anchor stent via the femoral vein interatrial septum according to an embodiment of the present invention. [Figure 19] Figures 19A-B are schematic diagrams illustrating the process of approaching a transcatheter bioprosthetic mitral valve via the femoral vein interatrial septum and delivering it to an anchor stent, according to an embodiment of the present invention. [Figure 20] Figures 20A-C are schematic diagrams illustrating the process of approaching a transcatheter mitral valve anchor stent via a composite pathway according to an embodiment of the present invention. [Figure 21] Figures 21A-D are schematic diagrams illustrating the process of approaching a transcatheter artificial mitral valve via a composite pathway according to an embodiment of the present invention and delivering it to an anchor stent. [Modes for carrying out the invention]
[0017] Details of the present invention will become clear in conjunction with the drawings and the above-mentioned specific description of the invention. However, the specific embodiments of the invention described herein are for the purpose of interpreting the object of the invention and do not limit the invention in any way. Under the teachings of the present invention, those skilled in the art can conceive of any possible modifications based on the invention, all of which should be considered to fall within the scope of the invention.
[0018] This invention provides a transcatheter with separate, precise anchoring capabilities. Mitral valve Regarding the system, the system includes a separate transcatheter Mitral valve The anchor stent 10 and the transcatheter artificial biopsy Mitral valve 20 and the transcatheter Mitral valve The morphology and structure of the anchor stent were reconstructed three-dimensionally based on the patient's imaging data. Mitral valve Matching the true anatomical structure of the lesion, the transcatheter Mitral valve The anchor stent is first inserted through a catheter into the patient's lesion. Mitral valve Displacement, deformation, patient Mitral valve Transported for alignment and bonding with the supraglatum and subvalvular tissues, the transcatheter artificial body Mitral valve This is a transcatheter that is aligned and joined to the tissue via a catheter. Mitral valve It is transported into the anchor stent and released, and the transcatheter artificial body Mitral valve It is released, deformed, and expands into a functional state, and the transcatheter Mitral valve The anchor stent was deformed again and expanded Transcatheter artificial mitral valve At the same time as connecting with the transcatheter Mitral valve Further deformation of the anchor stent can cause the anchor stent and the lesion to... Mitral valve And by achieving reconnection with subvalvular tissue, transcatheter artificial biopsy Mitral valve To achieve the final anchor. Because the true lesion differs from patient to patient, a transcatheter is designed and reconstructed three-dimensionally based on the patient's imaging data. Mitral valveThe anchor stents are not the same and are adjusted according to the patient's actual condition, and as shown in Figures 4A-D, there are four types of separate anchor stents with different supravalvular and subvalvular structures and transcatheter artificial biopsies. Mitral valve These are schematic diagrams illustrating the combinations, but the general structure and configuration of each is based on the same design philosophy and principles.
[0019] As shown in Figures 5-7, the transcatheter according to the present invention Mitral valve The anchor stent 10 is a funnel-shaped umbrella-type stent structure with a large atrial surface and a small ventricular surface, and includes an atrial surface 11, a ventricular surface 12, and a connection portion 13 between the two of them for the anchor stent, wherein the atrial surface is umbrella-like and matches the true form reconstructed three-dimensionally based on image data of the patient's left atrial surface, i.e., a first lattice portion, and the ventricular surface 12 is the patient's lesion Mitral valve The stent includes multiple positioning hook loops 121 and anchor hook loops 122 that match the true morphology reconstructed three-dimensionally based on subvalvular image data, wherein the anchor stent connection portion 13 is a rounded funnel-shaped structure that is larger at the top and smaller at the bottom between the atrial and ventricular surfaces, and the length of the connection portion corresponds to the transcatheter artificial body. Mitral valve It has a second lattice section 123 that matches the height and is expandable in a cylindrical shape. As shown in Figures 5A-5C, schematic diagrams of separate anchor stents for different supravalvular and subvalvular structures show that the overall structure is the same, but the number, angle, length, etc., of the atrial surface 11 with different degrees of curvature, positioning hook loops 121, and anchor hook loops 122 are designed to match the patient tissue of different patients. That is, transcatheter Mitral valve The morphology and coverage area of the atrial surface of the anchor stent, as well as the morphology, number, length, angle, and structural relationship of the ventricular surface and anchor hook loop of the anchor stent, were determined by correlating the true size of each diameter limiting structure measured by referring to the true structure of the patient's atrium (supravalvular) 40 and ventricle (subvalvular) 50 after three-dimensional reconstruction (3mensio) based on the patient's individual preoperative CT image data, and three-dimensional ultrasound images, transcatheterization. Mitral valveWe designed the machining drawings for the anchor stent and ultimately created a unique product by performing three-dimensional laser cutting and three-dimensional forming of specific nickel-titanium memory alloy tubing. Mitral valve We manufacture anchor stents.
[0020] Referring to Figures 8A-8C, the anchor stent and Transcatheter artificial mitral valve To further strengthen the connection with the transcatheter Mitral valve At the end of the atrial surface 11 of the anchor stent connection, a transcatheter Mitral valve Multiple fixing support rods 111 are provided for inserting the anchor stent, and the fixing support rods extend axially along the atrial plane, after which their ends bend toward the axis of the anchor stent. Alternatively, Mitral valve The connection point of the anchor stent is transcatheter Mitral valve Multiple terminal centripetal hooks 112 are provided for inserting the outflow end of the anchor stent. Mitral valve In the first anchoring state of the anchor stent, the fixing support rod 111 maintains an angle that coincides with the connection portion of the anchor stent, and the transcatheter Mitral valve In the second anchoring state of the anchor stent, the plurality of fixing support rods 111 surround the axis, are parallel in the axial direction, and the ends of the fixing support rods are Transcatheter artificial mitral valve It is fitted into the stent at the inlet end, Transcatheter artificial mitral valve The fixing support rods 111 are fixed in place to prevent displacement to the atrial surface. There are 3 to 12 of these fixing support rods 111.
[0021] The transcatheter Mitral valve The first and second lattice portions of the anchor bolt are formed by unit lattices consisting of compressible rhombic lattices, V-lattices, and / or hexagonal or polygonal lattices, and the first and second lattice portions are adaptively connected. Mitral valve The distance between the outer edge of the lattice portion on the atrial surface of the anchor stent and the patient's atrial wall is 1 to 2 mm, preferably 1.5 mm. Mitral valveThe diameter of the inner periphery of the second lattice portion of the anchor stent is the diameter of the transcatheter artificial body. Mitral valve It matches the outer diameter of various corresponding size standards. The transcatheter Mitral valve The surface of the anchor stent graft is coated with a thin film of medical polymer. Mitral valve The atrial surface, ventricular surface, and connection portion of the anchor stent are either a three-dimensional molded structure after laser integral cutting or a reconnected structure after separate processing of the atrial surface, ventricular surface, and connection portion of the anchor stent. The anchor stent is made of a metallic or non-metallic material with shape memory properties that allows for shape recovery, for example, a nickel-titanium alloy.
[0022] Based on the true data of the above patient's unique image, Mitral valve The anchor stent is manufactured by processing it in the pre-grasp state of the stent, that is, the stent is transmitted via the catheter. Mitral valve This is the first anchoring state after being transported to and released at the lesion's valve orifice, as shown in Figures 9A-9C. Transcatheter Mitral valve In the second anchor state of the anchor stent, Transcatheter artificial mitral valve It is transported into the anchor stent via a catheter and expanded with the assistance of a balloon. Transcatheter artificial mitral valve It expands (or the nickel-titanium memory alloy stent expands on its own) Mitral valve The anchor stent deforms from the first anchor state to the second anchor state, and the deformation force of the stent Transcatheter artificial mitral valve It combines with the balloon expansion force and becomes one, as shown in Figures 10A-10C. At the same time, the anchor hook loop on the ventricular side of the anchor stent, which is inserted in alignment with the subvalvular chordae tendineae and subvalvular tissue, Transcatheter artificial mitral valveUnder the action of the balloon expansion force, as the anchor stent deforms from the first anchor state to the second anchor state, the anchor hook loop on the ventricular surface becomes more tightly coupled with the chordae tendineae and subvalvular tissue 51, achieving the final anchor, as shown in Figure 11. At the same time, in the first anchor state of the anchor stent, the atrial-side fixing support rod or stent bend of its connection structure becomes enclosed toward the axis and parallel to the axial direction as it deforms into the second anchor state, and the entanglement force of the stent at the ventricular end of the connection between the end of the fixing support rod or stent bend and the transcatheter Mitral valve The support rods at both ends of the stent catch on, and this anchor stent and transcatheter Mitral valve The automatic hooking mechanism at both ends of the stent is Transcatheter artificial mitral valve The anchor stent is precisely joined and integrated, Transcatheter artificial mitral valve The displacement of 0 is ensured, as shown in Figures 8A-8C.
[0023] The core of the inventive step of this invention is as follows: (1) An anchor stent and Transcatheter artificial mitral valve These are two independent forms, devices with different structures but that can be connected to each other, each connected via a catheter. Mitral valve It is transported to the position anterior to posterior, and according to the structural design, the anchor stent first connects to and clamps the valve of the lesion, and then Transcatheter artificial mitral valve (2) The stent is released by balloon expansion, deformed and integrated. (2) The junction and clamping of the anchor stent to the valve of the lesion is performed according to the patient's unique preoperative lesion. Mitral valve The structure is designed and fabricated based on dynamic image data of the supravalve and subvalve structures and is three-dimensionally shaped. (3) In order to ensure interlocking between the anchor stent and the valve of the lesion, the stent is designed with two positioning hook loops. Mitral valve By utilizing the boundary between the two valve lobes, the placement of the anchor stent, which has a similar morphology to the atrial surface, is precisely positioned, and the structure of the anchor hook loop beneath the valve of the stent and Mitral valveThe chordae tendineae and papillary muscles of the lobe are aligned and joined in a predetermined number of positions. (4) The first anchor state (funnel-shaped) after the anchor stent is released is designed as a conical funnel shape based on the patient's unique true pathological anatomical structure, and is a transient state prior to the second state (cylindrical), thereafter, Transcatheter artificial mitral valve The deformation force released by the balloon expansion deforms the anchor stent into a cylindrical second anchor state, and the repulsive force that deforms and memorizes the nickel-titanium alloy and the transcatheter Mitral valve of stent The combined force of the radial support force and the subvalvular support force deforms the clamped anchor stent above and below the valve into a cylindrical second anchor state, tightening the subvalvular tissue between the anchor stent and the ventricular wall again, completing the final anchor. (5) The anchor stent deforms from the first state to the second state, and this deformation process is Transcatheter artificial mitral valve This enables automatic integration with, Transcatheter artificial mitral valve The release operation can be performed automatically and accurately.
[0024] Transcatheter artificial body according to the present invention Mitral valve Because the anchor stent is attached, stent The structure includes a cobalt-chromium alloy anchor stent that serves only to rationally support three valve leaves and becomes cylindrical after being compressed radially and expanded by a balloon, or a nickel-titanium alloy anchor stent that becomes cylindrical after being compressed radially and self-expanding, and three fan-shaped valve leaves provided inside the stent, each having a free edge, an arc-shaped base, and valve leaf boundary connectors extending on both sides, and the stent is graspable in various forms that can support and fix a metal net tube or the boundaries of the three valve leaves. stent That is the case. stent These are cobalt-based alloys, cobalt-chromium alloys, or nickel-titanium alloys. See Figures 12A-12B.
[0025] The present invention provides a separate, precisely anchored transcatheter. Mitral valveThe system further includes a transport assembly, the transport assembly further includes a transport assembly, the transport assembly is transcatheter Mitral valve A transport kit for anchor stents and transcatheter artificial biopsy. Mitral valve Includes a transport kit 30 and the transcatheter Mitral valve The anchor stent transport kit includes a transport catheter 31 and a transcatheter catheter. Mitral valve The loader 32 of the anchor stent is included. Mitral valve The transport kit is for transcatheter artificial biopsies. Mitral valve The transcatheter includes transport equipment, guide sheath, valve gripper, and charge pump (all similar to those in the prior art and not shown in the figure). Mitral valve Transport equipment for anchor stents and transcatheter artificial bodies Mitral valve The transport device can be accessed via femoral vein interatrial septum, apical puncture, or left atrial puncture route.
[0026] The present invention provides a separate, precisely anchored transcatheter. Mitral valve When performing transcatheter treatment using the system, the approach can be via an apical approach, a femoral vein-right atrial septal approach, or, if necessary, a combination of both approaches simultaneously.
[0027] Figures 14 to 16 show the apical approach routes.
[0028] The apical approach is a well-known embodiment among cardiac surgeons. First, the loaded anchor stent is placed through the apical approach to the patient's lesion. Mitral valve Transport the stent inward (Figure 15A), release the positioning hook loop (Figure 15B), complete the positioning (Figure 15C), sequentially release the atrial surface of the anchor stent (Figure 15D), the stent's connecting structure and ventricular surface, align and connect the anchor hook loop on the ventricular surface (Figure 15E), remove the anchor stent transport equipment, and re-load the pre-loaded stent along its original path. Transcatheter artificial mitral valve Transported to the original path of the anchor stent and pre-loaded Transcatheter artificial mitral valve It is transported into the anchor stent (Figure 16A), and then, with the assistance of a balloon... Transcatheter artificial mitral valve Expand it and deform the anchor stent into a second anchor state, Transcatheter artificial bioprosthetic mitral valve and This ensures precise connection and simultaneously completes the final anchor through fastening to the subvalvular tissue (Figure 16B).
[0029] Figures 17-19 show an approach to the interatrial septum from the right atrium via the femoral vein.
[0030] The atrial septal approach route via the femoral vein is a well-known embodiment among internists. A loaded anchor stent is inserted through the femoral vein to access the atrial septum from the right atrium to the patient's lesion. Mitral valve The anchor stent is transported inward (Figure 18A), the positioning hook loop is released to complete the positioning (Figure 18B), the ventricular surface of the anchor stent (Figure 18C), the stent's connecting structure and atrial surface are sequentially released, the anchor hook loop on the ventricular surface is aligned and joined, i.e., the first anchor state of the anchor stent (Figure 18C), the transport equipment for the anchor stent is removed, and it is loaded along its original path. Transcatheter artificial mitral valve It is transported into the anchor stent (Figure 19A), and then, with the assistance of a balloon... Transcatheter artificial mitral valve Expand it and deform the anchor stent into a second anchor state, Transcatheter artificial mitral valve This ensures precise connection with the subvalvular tissue, while simultaneously forming a clamping force with the subvalvular tissue, thus completing the final anchor (Figure 19B).
[0031] The transcatheter of the present invention Mitral valve The system is a composite approach route; see Figure 20.
[0032] The combined approach is suitable for cases where preoperative image analysis reveals a complex cardiac structure and the robustness of the first-state anchor connection of the designed transcatheter anchor stent is uncertain. The loaded anchor stent is inserted through the apical approach to the patient's lesion. Mitral valveThe anchor stent is transported internally, the positioning hook loop is released and positioned (Figure 20A), the atrial surface and connection portion of the anchor stent are sequentially released (Figure 20B), and then the ventricular surface of the anchor stent is released to align and connect the anchor hook loop, which is the first state of the anchor stent (Figure 20C). After the anchor stent is pulled without removing the anchor stent transport equipment, it is simultaneously loaded through the venous pathway and atrial septum into which the guidewire has been inserted beforehand. Transcatheter artificial mitral valve The device is transported into the anchor stent (Figure 21A), and with the assistance of a balloon... Transcatheter artificial mitral valve Expand it and deform the anchor stent into a second anchor state, Transcatheter artificial mitral valve This ensures precise connection with the subvalvular tissue and secures the final anchor (Figure 21B). Transcatheter artificial mitral valve The transport equipment is removed (Figure 21C), the second anchor state of the anchor stent is confirmed to be in the design state, and after the anchor has become firm, the transport equipment of the anchor stent is removed (Figure 21D).
[0033] The above examples are merely intended to adequately illustrate embodiments of the specifications given by the present invention.
[0034] The transcatheter of the present invention Mitral valve The system has already implemented the aforementioned technical proposal through industrial animal testing and has been confirmed by those skilled in the art.
[0035] The feasible significance of the present invention is as follows: (1) The separate design functionally separates the valve leaflet support and the valve anchor, Mitral valveBy transferring the valve anchor at the position to the anchor stent, personalized anchor design can be achieved, and at the same time, the transcatheter anchor stent and transcatheter valve can be performed in stages, preventing the structure from becoming too complex and the volume too large after compression, which would make transport via the catheter difficult. (2) Based on the anatomical structural characteristics of the valve lesion, the anchor principle and final anchor site are pre-designed and measured to determine the second anchor state of the anchor stent, and the anchor stent is constructed using the patient's personalized anatomical data, dedicated software, and 3D printing tests to complete the three-dimensional morphological design and fabrication of the pre-set transient state, i.e., the first anchor state, in terms of the size and dimensions of each part, and after being discharged via the catheter, it is precisely positioned to provide support for the smooth transport of the transcatheter valve. The gradient structure of the first state of the anchor stent can open moderately wide and can also suppress severe regurgitation. The former not only provides a channel to the transcatheter valve but can also prevent the stenotic lesion from suddenly expanding, and the latter reduces the large amount of perfusion in valve regurgitation. Mitral valve (3) The external force released from the valve drives the anchor stent, deforming it from a funnel-shaped first anchor state to a cylindrical second state. This deformation causes the anchor stent to firmly grasp the valve towards the axis, ensuring zero displacement of the valve for mating with the transcatheter valve. The anchor hook-loop structure on the ventricular surface further tightly connects to the subvalvular tissue, completing the pre-designed alignment anchor and forming a clamp with the supravalvular structure to achieve the final anchor. (4) Transcatheter Mitral valve The support rod structure, which is positioned transcatheterally between the inlet and outlet ends of the connection part of the anchor stent, is from both ends Transcatheter artificial mitral valve (5) A transcatheter capable of precise anchoring of the separate type described above. Mitral valve The system is a one-time, unique, predetermined Mitral valve Each time the treatment process is completed, accurately performing the transcatheterization, the relevant data is analyzed, and the transcatheterization is performed. Mitral valveFor the entire process of anchor stent morphological design, fabrication and manufacturing, and transcatheter treatment, as well as related data and postoperative progress data acquired throughout this process, a large amount of unique image data, anchor stent design and fabrication and manufacturing parameters, transcatheter treatment process and postoperative results are stored as a single independent data unit, enabling accurate anchoring of the separate transcatheter system. Mitral valve This system enables smart, commercial, and large-scale implementation of treatment via catheter.
Claims
1. Includes a separate transcatheter mitral valve anchor stent and a transcatheter artificial bioprosthetic mitral valve. fruit, The anchor stent of the transcatheter mitral valve has a compressed state in which it is placed inside the catheter, a first anchor state after it has been released through the catheter, and a second anchor state after it has been coupled to a transcatheter artificial biomimetic mitral valve. In the first anchor state, the transcatheter mitral valve anchor stent, after being released through the catheter, is used to deform to align, bond, and clamp with the supravalvular and subvalvular tissues at the patient's mitral valve site. In the second anchoring state, the transcatheter artificial biomimetic mitral valve is introduced by the catheter into the anchor stent of the transcatheter mitral valve in the first state, expands and undergoes secondary deformation by the external force of balloon expansion, and is used to anchor by integrally bonding with the expanded anchor stent of the transcatheter artificial biomimetic mitral valve and simultaneously completing the bonding between the anchor stent of the transcatheter mitral valve and the tissue at the patient's mitral valve site. The aforementioned transcatheter mitral valve anchor stent is an umbrella-shaped stent structure and includes an atrial surface, a ventricular surface, and a connection portion between the two anchor stent surfaces, wherein the atrial surface is umbrella-like, i.e., a first lattice portion, the ventricular surface includes two positioning hook loops set at the boundary positions of the two anterior and posterior lobes of the patient's mitral valve, and the connection portion of the anchor stent is round-opening funnel-shaped, the opening diameter of the funnel matches the inner diameter of the annulus of the patient's mitral valve, and a second lattice portion opens at the lower end of the funnel to match the morphology and degree of the stenosis and / or regurgitation lesion of the mitral valve lobe. In the first anchoring state, the transcatheter mitral valve anchor stent is processed into a funnel shape with a large atrial surface and a small ventricular surface, and the transcatheter mitral valve anchor stent is used to achieve positional bonding and clamping in accordance with the supravalvular and subvalvular tissues of the patient's dynamic lesion through deformation and shape recovery after being injected and released via the catheter. In the second anchoring state, the transcatheter mitral valve anchor stent in the first anchoring state and the transcatheter bioprosthetic mitral valve transported via the catheter are expanded and integrated by a balloon, and are clamped by the secondary deformation of the transcatheter mitral valve anchor stent from its original funnel shape to a cylindrical shape, thereby restoring its shape toward the axis and bonding with the transcatheter bioprosthetic mitral valve, while simultaneously completing the connection with the patient's mitral valve position and subvalvular tissue. A transcatheter mitral valve system characterized by the ability to use a separate anchor.
2. The mitral valve system further includes a transport assembly, the transport assembly includes a transport kit for a transcatheter mitral valve anchor stent and a transport kit for a transcatheter bioprosthetic mitral valve, the transport kit for a transcatheter mitral valve anchor stent includes a transport catheter, a transport device for the transcatheter mitral valve anchor stent, and a stent loader. A transcatheter mitral valve system with a separate anchor as described in claim 1.
3. The first anchor state of the connection portion of the anchor stent is a three-dimensional fixed memory state of the true anatomical form and structure of the corresponding patient after being transported and released via the catheter, and the fixed memory state of the connection portion from the atrial surface to the ventricular surface is such that, depending on the morphology of the patient's lesioned valve leaflets, the connection portion of the anchor stent deforms from a rounded funnel shape in the first anchor state to a cylindrical second anchor state through deformation and expansion. A transcatheter mitral valve system with a separate anchor as described in claim 1.
4. In the first anchoring state of the transcatheter mitral valve anchor stent, the positioning hook loop, after being released through the catheter, is inserted into the boundary position of the two anterior and posterior lobes of the mitral valve of the patient's lesion that matches it, thereby achieving a correspondence between the atrial surface of the transcatheter mitral valve anchor stent and the morphology of the patient's left atrium, and is used to position and lay the stent. A transcatheter mitral valve system with a separate anchor as described in claim 3.
5. The ventricular surface of the aforementioned transcatheter mitral valve anchor stent has multiple anchor hook loops that extend from the connection point to the ventricular surface and then fold back to match the morphology of the true chordae tendineae and subvalvular tissue structures of the mitral valve in the patient's lesion. A transcatheter mitral valve system with a separate anchor as described in claim 1.
6. The number, size, shape, and angle of the anchor hook loops are matched to the true chordal gap of the mitral valve in the patient's lesion, the size and shape of the mitral valve leaflets, and the circumferential spacing between the perivalvular tissue and the ventricular wall. A transcatheter mitral valve system with a separate anchor as described in claim 5.
7. The atrial surface end of the connection portion of the anchor stent for the transcatheter mitral valve is provided with a plurality of fixing support rods for inserting the stent of the transcatheter artificial bioprosthetic mitral valve, and the fixing support rods extend along the axial direction of the atrial surface, after which their ends bend toward the axis of the anchor stent. A transcatheter mitral valve system with a separate anchor as described in claim 1.
8. The connection portion of the anchor stent of the mitral valve is provided with multiple terminal centripetal hooks for inserting the outflow end of the stent of the transcatheter artificial biomimetic valve, and the centripetal hooks and multiple fixing support rods of the mitral valve are structurally fitted together and integrated with the transcatheter artificial biomimetic valve. A transcatheter mitral valve system with a separate anchor as described in feature 7.
9. In the first anchoring state of the transcatheter mitral valve anchor stent, the plurality of fixing support rods maintain an angle that coincides with the connection portion of the anchor stent, and in the second anchoring state of the transcatheter mitral valve anchor stent, the ends of the plurality of fixing support rods are fitted into the inlet end of the stent of the transcatheter artificial biomimetic valve, so that they are structurally integrated with the transcatheter artificial biomimetic valve. A transcatheter mitral valve system with a separate anchor as described in feature 7.
10. The aforementioned fixed support rods number from 3 to 12. A transcatheter mitral valve system with a separate anchor as described in feature 7.
11. The first and second lattice portions of the transcatheter mitral valve anchor stent include compressible rhomboid lattices, V-lattices, and / or hexagonal lattices, and the first and second lattice portions are connected. Transcatheter mitral caps capable of separate anchors as described in feature 1. Valve system.
12. The distance between the outer edge of the lattice portion on the atrial surface of the aforementioned transcatheter mitral valve anchor stent and the patient's atrial wall is 1 to 2 mm. A transcatheter mitral valve system with a separate anchor as described in claim 1.
13. The diameter of the inner circumferential edge of the second lattice portion of the anchor stent of the transcatheter mitral valve matches the outer diameter of various corresponding size standards of transcatheter artificial bioprosthetic mitral valves. Transcatheter mitral caps capable of separate anchors as described in feature 1. Valve system.
14. The surface of the aforementioned transcatheter mitral valve anchor stent is coated with a thin film of medical polymer. A transcatheter mitral valve system capable of using a separate anchor as described in claim 1 or 2.
15. The atrial surface, ventricular surface, and connection portion of the anchor stent of the aforementioned transcatheter mitral valve are either a three-dimensional molded structure after laser integral cutting or a reconnected structure after separate processing of the atrial surface, ventricular surface, and connection portion of the anchor stent. A transcatheter mitral valve system capable of using a separate anchor as described in claim 1 or 2.
16. The anchor stent of the transcatheter mitral valve is made of a metallic or non-metallic material that has shape memory properties that allow it to recover its shape. A transcatheter mitral valve system capable of using a separate anchor as described in claim 1 or 2.
17. The anchor stent for the transcatheter mitral valve is made of nickel-titanium alloy. A transcatheter mitral valve system capable of using a separate anchor as described in claim 1 or 2.
18. The transcatheter artificial mitral valve comprises a cobalt-chromium alloy stent that is cylindrical or partially cylindrical after being compressed radially and expanded by a balloon, or a nickel-titanium alloy stent that is self-expanding after being compressed radially, and three fan-shaped valve leaves provided inside the cobalt-chromium alloy stent or the nickel-titanium alloy stent, each of which has a free edge, an arc-shaped base, and valve leaf boundary connectors extending on both sides, and the cobalt-chromium alloy stent or the nickel-titanium alloy stent is a stent that can be grasped in various forms that can support and fix the boundaries of the three pairs of valve leaves. A transcatheter mitral valve system capable of using a separate anchor as described in claim 1 or 2.
19. The stent for the artificial mitral valve is made from a cobalt-based alloy, chromium alloy, or nickel-titanium alloy. A transcatheter mitral valve system that allows for a separate anchor as described in claim 1 or 2, characterized in that it is characterized by the features described in claim 1 or 2.
20. The aforementioned transcatheter bioprosthetic mitral valve transport kit includes a transport device for the transcatheter bioprosthetic mitral valve, a guide sheath, and a valve gripper. A transcatheter mitral valve system with a separate anchor as described in claim 2.