A transcatheter annular valve system with separate components for precise anchoring.

Abstract

A separate, precisely anchored transcatheter annular valve system includes a separate transcatheter annular valve anchor stent (10) and a transcatheter biological prosthetic annular valve (20), the shape and structure of the transcatheter annular valve anchor stent (10) being matched to the true annular, supravalvular and subvalvular structures after three-dimensional reconstruction based on image data of a patient due to postoperative valvular dysfunction of a previously implanted valvuloplasty annulus (30), the transcatheter annular valve anchor stent (10) being first subjected to a stenting test to determine whether the annular valve anchor stent (10) is released, deformed, or is attached to the supravalvular and subvalvular structures of the dysfunctional annulus of the patient. The transcatheter annular valve prosthesis (20) is delivered into the transcatheter annular valve anchor stent (10) and released, the valve leaflet stent of the transcatheter annular valve prosthesis (20) is deformed and expanded to a functional state of the transcatheter annular valve, the annular valve anchor stent (10) is deformed again to be connected to the expanded transcatheter annular valve, and at the same time, the transcatheter annular valve anchor stent (10) is deformed again to be connected to the subvalve tissue again for anchoring.

Description

Technical Field

[0001] The present invention relates to an artificial biological heart valve, and particularly to a transcatheter annuloplasty valve system capable of an accurate separate anchor.

Background Art

[0002] According to the estimated prevalence rate of valvular heart disease in China of 3.8%, there are approximately 25 million valvular disease patients in China (BMC Cardiovasc Disord. 2021, 21:339). Since most domestic patients who need treatment are 65 years old or younger, artificial valve replacement by valvular surgery or repair by valvuloplasty should be the main treatment means for some time to come. The former requires inserting an artificial heart valve, and the latter Valve repair ring needs to be inserted to complete the repair of the valve. In 2021, the estimated number of tricuspid valves Plastic surgery ring was approximately 26,000, and the mitral valve Plastic surgery ring was approximately 14,000. The cumulative number of annulus uses has already significantly exceeded the number of artificial biological valves and continues to increase in double digits every year. Furthermore, the popularization of valvuloplasty in China, the time of popularization, and the accumulation of surgical experience are limited. Especially since the proportion of degenerative changes in valves is lower than that in European and American countries, postoperative patients who undergo repair by valvuloplasty using these Valve repair ring implanted valves will inevitably face valvuloplasty when they become older and must undergo transcatheter annuloplasty valve (ViR) treatment.

[0003] According to many documents, due to the differences in the materials, structures, and forms of the previously implanted Valve repair ring (Figure 1), compared with transcatheter valve-in-valve (ViV), the postoperative complications, the function of the annuloplasty valve in the mid-term after surgery, and the quality of life of ViR are all reported to be much lower than the treatment effect of ViV. The researchers believe that these problems of ViR are mainly due to the deformation after ViR implantation and inevitable more paravalvular leakage caused by the irregular materials, forms, and structures of the previously implanted Valve repair ring valves. Therefore, the present invention provides the design of a separate transcatheter annuloplasty valve system.

Summary of the Invention

[0004] This invention is previously transplanted Mitral valve repair ring or tricuspid Valve repair ring The objective is to provide a stable and accurate transcatheter anchor for balloon-expanded ring valves by installing a stable, regular, and circular support structure within it. The transcatheter ring valve system of the present invention consists of two parts: one transcatheter ring valve anchor stent and one transcatheter artificial bio-ring valve. The core of the invention is that after being three-dimensionally reconstructed based on preoperative personalized image data... Valve repair ring Based on the true anatomical structure of the supravalvular and subvalvular regions, Valve repair ring A single system is customized and fabricated to accommodate the form, structure, and size, and then positioned and ejected. Valve repair ring It automatically adapts internally, achieving progressive bonding and clamping with the supravalvular and subvalvular tissues, and then the artificial biorecirculating valve is transported into the anchor valve stent via a catheter and released by balloon expansion, thereby, Transcatheter artificial biorecirculating valve This enables the internal assembly and connection of the anchor stent, and the central axis of the connection part of the anchor stent and the anteriorly implanted Valve repair ring Because it is coaxial with the center, Transcatheter artificial biorecirculating valve This enabled precise anchoring and resulted in therapeutic effects similar to or better than ViV.

[0005] A specific technical proposal according to the present invention is a transcatheter ring valve system capable of separate, precise anchoring, the system comprising a separate transcatheter ring valve anchor stent and a transcatheter artificial bioreceptor valve, the morphology and structure of the transcatheter ring valve anchor stent being previously implanted Valve repair ring Based on the patient's imaging data for postoperative valve dysfunction, the following three-dimensional reconstructions were made. Valve repair ring Matching the true structure of the supravalvular and subvalvular valves, the anchor stent of the transcatheter ring valve first addresses the patient's dysfunction. Valve repair ring Internal release, deformation, and dysfunction Valve repair ringThe transcatheter artificial biorecircular valve is transported for alignment and bonding with the supravalvular and subvalvular tissues, and the transcatheter artificial biorecircular valve is transported and released into the anchor stent of the transcatheter artificial biorecircular valve. stent It is deformed Transcatheter artificial biorecirculating valve The functional state is expanded, and the anchor stent of the ring valve is deformed again and expanded Transcatheter artificial biorecirculating valve Simultaneously with the bonding, the anchor stent of the transcatheter ring valve is deformed again, and anchored by re-bonding the anchor stent to the subvalvular tissue.

[0006] Furthermore, the anchors, which are re-bonded, are pre-set anchors to achieve a precise, regular circular shape. The intercatheter valve system further includes a transport assembly, which is a transport kit for the anchor stent of the transcatheter intercatheter valve and Transcatheter artificial biorecirculating valve The transport kit includes the transport catheter and the loader for the transcatheter ring valve anchor stent. Valve repair ring Each type of etiology Mitral valve Each type transplanted due to closure failure Mitral valve repair ring It is either a tricuspid valve ring of each type implanted for each type of pathogenic tricuspid valve regurgitation, and the morphology and structure of the anchor stent of the transcatheter ring valve is previously implanted. Valve repair ring Based on the type and individualized imaging data of postoperative valve dysfunction, the true morphology and anatomical structure are precisely matched to the three-dimensional reconstruction. The transcatheter intercircular valve anchor stent and the transcatheter artificial bioreceptor valve are approached anteriorly and posteriorly, respectively, and then reintegrated in the body. The transcatheter intercircular valve anchor stent is deformed again by the release of the transcatheter valve, and the lesion Mitral valve Alternatively, a regular circular pre-set anchor is completed with the tricuspid valve and subvalvular tissue, and the anchor of the transcatheter artificial biorecircular valve is implanted beforehand. Valve repair ring This achieves permanent stability of a regular circular anchor, unaffected by the stress of its shape. The transcatheter ring valve is Valve repair ring Medium Mitral valveand Valve repair ring It is a tricuspid valve. The anchor stent of the transcatheter ring valve has a compressed state in which it is placed inside the catheter, and a first anchor state after it has been released through the catheter. Transcatheter artificial biorecirculating valve It has a second anchor state after being coupled, and in the first anchor state, the anchor stent of the ring valve is released through the catheter and then causes the patient's dysfunction Valve repair ring It deforms to align and join with the structures above and below the valve, and in the second anchor state, the anchor stent of the ring valve is expanded by the catheterized ring valve and undergoes secondary deformation. Transcatheter artificial biorecirculating valve At the same time as binding, patient dysfunction Valve repair ring The final anchor connection with the subvalvular tissue is completed. In the second anchor state, the transcatheter artificial biorenal valve is delivered by the catheter into the anchor stent of the transcatheter biorenal valve in the first state and released by balloon expansion, the external force from balloon expansion causes secondary deformation of the anchor stent of the biorenal valve, and the expanded transcatheter artificial biorenal valve is integrally connected with the anchor stent and the patient Mitral valve Complete a regular circular pre-set anchor with the valve lobe or subvalvular tissue at the position or tricuspid valve position. In the first anchor state, the transcatheter ring valve anchor stent is previously implanted Valve repair ring Based on the type, shape, and size, and the anatomical structure reconstructed three-dimensionally based on personalized image data, the anchor stent of the transcatheter ring valve is processed into a conical funnel shape with a large atrial surface and a small ventricular surface, and the deformation and shape recovery after being delivered and released through the catheter will improve the patient's dysfunction. Mitral valveAlternatively, by precisely corresponding to the supravalvular and subvalvular tissues of the tricuspid valve and achieving unique positional bonding and clamping, a regular circular pre-set structure is reconstructed. In the second anchor state, within the transcatheter intercircular valve anchor stent in the first anchor state, the transcatheter artificial bio-intercircular valve is approached via the catheter and released by balloon expansion, integrally bonding with the transcatheter intercircular valve anchor stent. The transcatheter intercircular valve anchor stent expands from its original conical funnel shape to a cylindrical shape together with the transcatheter intercircular valve, and is clamped by axial shape recovery through secondary deformation, tightly bonding with the transcatheter intercircular valve at the same time as the patient Mitral valve Complete the anchoring of the position or tricuspid valve position and the tight pre-set relationship with the subvalvular tissue.

[0007] Furthermore, 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 dynamic image of a virtual simulation after digitizing integrated CT, ultrasound, and nuclear magnetocardiography images and a corresponding 3D printed simulation physical model. The anchor stent of the annular valve is an umbrella-shaped stent structure and includes an atrial surface, a ventricular surface, and a connection portion of the anchor stent between them, wherein the atrial surface is umbrella-like and matches the true form three-dimensionally reconstructed based on the patient's atrial surface image data, i.e., a first lattice portion, the ventricular surface includes two positioning hook loops precisely pre-set at the boundary positions of the valve lobes, and the connection portion of the anchor stent is round-mouthed funnel-shaped and has a second lattice portion. The first anchor state of the connection portion of the annular valve anchor stent is the first state after it has been transported and released via the catheter, and is the fixed shape memory state outside the body of the stent. The fixed shape memory state of the connection portion from the atrial surface to the ventricular surface has a contraction gradient, the gradient being 5 to 45 degrees, and the connection portion of the anchor stent deforms from the first anchor state to a cylindrical second anchor state by deformation and expansion. There are two positioning hook loops, and the patient Mitral valve The two lobes ( Mitral valvePrecise alignment matching is performed with the boundary position of the reconstructive ring, or there are three, and the three lobes of the tricuspid flap ( Mitral valve repair ring ) to perform precise positional matching with the boundary position. In the first anchor state of the transcatheter Lubuin ring anchor stent, the positioning hook loop is released from the atrial surface of the ring valve anchor stent via the catheter and matched with the patient's Mitral valve Alternatively, it is inserted at the valve leaflet boundary of the tricuspid valve, ensuring that the atrial surface of the positioning anchor stent matches the morphology of the patient's atrium, and in the second anchor state after deformation of the transcatheter ring valve anchor stent, the outer circumference of the connection between the positioning hook loop and the anchor stent is Valve repair ring inside and Transcatheter artificial biorecirculating valve It is filled between the joint. In the second anchor state, the positioning hook loop is previously transplanted Valve repair ring It fills the eccentric region and is implanted in front of the central axis of the connection part of the anchor stent of the ring valve. Valve repair ring The center is made coaxial. The ventricular surface of the anchor stent of the ring valve has multiple anchor hook loops that extend from the connection to the ventricular surface and then fold back, in the patient's dysfunction Valve repair ring Based on subvalvular image data, it matches the true subvalvular tissue morphology reconstructed in three dimensions. In the first anchoring state of the interring valve anchor stent, the anchor hook loop is released through the catheter and then fails to reach the patient's functional Valve repair ring Aligned with the subvalvular tissue, in the second anchoring state of the interring valve anchor stent, the plurality of anchor hook loops deform to form a clamping portion by the combined force of the atrial surface and connection portion of the interring valve anchor stent, and the plurality of deformed anchor hook loops and the patient's dysfunction Valve repair ringIt is tightly coupled by confluence with the valve lobes and subvalvular tissue. The anchor hook loops number 2 to 9, preferably 4 to 6. The atrial surface end of the connection portion of the anchor stent of the intercatheter valve is provided with a plurality of fixing support rods or stent bends for inserting the transcatheter intercatheter valve stent, the fixing support rods or stent bends extending axially along the atrial surface direction, and their ends bending toward the axis of the anchor stent. The connection portion of the anchor stent of the intercatheter valve is provided with a plurality of terminal centripetal hooks for inserting the outflow end of the transcatheter intercatheter valve stent, and these centripetal hooks and the atrial surface end of the connection portion of the anchor stent of the intercatheter valve are surrounded above and below by a plurality of fixing support rods or bends for inserting the atrial end of the transcatheter intercatheter valve stent, forming a mating with the anchor stent and integrating them. Transcatheter artificial biorecirculating valveZero displacement is achieved during discharge. The number of fixed support rods or stent bends is 3 to 12, preferably 6 to 9. The first and second lattice portions of the anchor bolts of the interring valve 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. The distance between the outer edge of the atrial surface lattice portion and the patient's atrial wall is 1 to 2 mm, preferably 1.5 mm. The diameter of the inner edge of the second lattice portion matches the outer diameter of various corresponding size standards of transcatheter bioprosthetic interring valves. The surface of the interring valve anchor stent is coated with a thin film of medical polymer. The connection between the atrial surface, ventricular surface, and anchor stent of the interring valve anchor stent is a three-dimensional fabricated structure after laser integral cutting or a separate joint structure. The anchor stent is made of a metallic or non-metallic material having shape memory properties that allow it to recover its shape, and the anchor stent is made of a nickel-titanium alloy. The transcatheter artificial bio-ring valve includes a cobalt-chromium alloy stent that is cylindrical after being compressed radially and expanded by a balloon, or a nickel-titanium alloy stent that is cylindrical after being compressed radially and self-expanding, and three fan-shaped valve leaves provided inside the stent, each of the three fan-shaped valve leaves having a free edge, an arc-shaped base, and valve leaf boundary connections extending on both sides, and the stent is a metal net tube. stent The cobalt alloy is a cobalt-based alloy, a cobalt-chromium alloy, or a nickel-titanium alloy. The transport device for the anchor stent of the transcatheter intercircular valve and the transport device for the artificial bio-intercircular valve are approached from the inferior vena cava via the femoral vein, or transported from the superior vena cava via the jugular vein or subclavian vein to the tricuspid valve site. Mitral valve For the interatlantic valve, by apical approach, left atrial approach, or femoral vein atrial septal approach Mitral valve It will be transported to its location.

[0008] In this invention, accurate molding and anchoring for a single, unique pre-configuration are achieved. Transcatheter artificial biorecirculating valve Each time the treatment process is completed, all the above-related data is accumulated as a large amount of personalized data in independent data units, and the intelligence, large-scale production, and industrialization of the trans-catheter annulus mitral valve system that enables the accurate anchor of the separate type are realized by means of big data algorithms and AI. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] [Figure 1] FIG. 1 is a physical diagram of different types of mitral valve annuloplasty rings and tricuspid valve annuloplasty rings transplanted into the prior art. [Figure 2] FIG. 2 is a physical diagram of various molding rings in the prior art. [Figure 3] FIGS. 3A-B are molding schematic diagrams of the transplantation of the trans-catheter annulus mitral valve system according to an embodiment of the present invention. [Figure 4] FIG. 4 is a molding schematic diagram of the transplantation of the trans-catheter annulus mitral valve system according to an embodiment of the present invention. [Figure 5] FIG. 5 is a molding schematic diagram of the transplantation of the trans-catheter annulus mitral valve system according to an embodiment of the present invention. [Figure 6] FIG. 6 is a schematic diagram of the trans-catheter annulus mitral valve system according to an embodiment of the present invention. [Figure 7] FIG. 7 is a schematic diagram of the anchor stent of the trans-catheter annulus mitral valve according to an embodiment of the present invention. [Figure 8] FIG. 8 is a schematic diagram of the anchor stents of different forms of the trans-catheter annulus mitral valve according to an embodiment of the present invention. [Figure 9] FIG. 9 is a schematic diagram of the anchor stents of different forms of the trans-catheter annulus mitral valve according to an embodiment of the present invention. [Figure 10] FIG. 10 is a schematic diagram of the anchor stents of different forms of the trans-catheter annulus mitral valve according to an embodiment of the present invention. [Figure 11B] FIGS. 11A-B are schematic diagrams of the fixed support rod and centripetal bending of the anchor stent according to an embodiment of the present invention. [Figure 12]Figures 12A-C are schematic diagrams of the first anchor state of the transcatheter ring valve anchor stent according to an embodiment of the present invention. [Figure 13] Figures 13A-C are schematic diagrams of the second anchor state of the transcatheter ring valve anchor stent according to an embodiment of the present invention. [Figure 14] Figure 14 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 15] Figure 15 is a schematic diagram of a transcatheter artificial bio-ring valve according to an embodiment of the present invention. [Figure 16] Figure 16 is a schematic diagram of a transport system according to an embodiment of the present invention. [Figure 17] Figures 17A-E are schematic diagrams illustrating the process of approaching the anchor stent of a transcatheter intercircular valve via an apical approach according to an embodiment of the present invention. [Figure 18] Figures 18A-C are schematic diagrams illustrating the process of approaching the anchor stent of the intercircular valve via an apical approach according to an embodiment of the present invention. [Figure 19] Figures 19A-D are schematic diagrams illustrating the process of approaching the anchor stent of the interatrinal valve of the atrial septum via the femoral vein according to an embodiment of the present invention. [Figure 20] Figures 20A-C are schematic diagrams illustrating the process of approaching the transcatheter artificial intercircular valve of the atrial septum via the femoral vein according to an embodiment of the present invention and delivering it to the anchor stent. [Figure 21] Figures 21A-C are schematic diagrams illustrating the process of approaching the anchor stent of a transcatheter ring valve via a composite pathway according to an embodiment of the present invention. [Figure 22] Figures 22A-D are schematic diagrams of the process of delivering a transcatheter ring valve anchor stent via a composite pathway according to an embodiment of the present invention. [Figure 23] Figures 23A-F are schematic diagrams of a valve system in which the tricuspid valve position according to an embodiment of the present invention is transcatheterized into the transcatheter ring valve of the present application. [Figure 24]Figures 24A-B are schematic diagrams illustrating how the positioning hook loop of an anchor stent according to an embodiment of the present invention is filled into the eccentric region of a valve repair ring implanted in front of it. [Modes for carrying out the invention]

[0010] Referring to Figures 3-6, the separate, precisely anchored transcatheter intracircular valve system of the present invention comprises a separate transcatheter intracircular valve anchor stent 10 and a transcatheter artificial bio-intracircular valve 20, wherein the morphology and structure of the transcatheter intracircular valve anchor stent are previously implanted. Valve repair ring Based on imaging data from 30 patients with postoperative valve dysfunction, the images were reconstructed in three dimensions. Valve repair ring Matching the true structure of the supravalvular and subvalvular valves, the anchor stent of the transcatheter ring valve first addresses the patient's dysfunction. Valve repair ring Internal release, deformation, and dysfunction Valve repair ring Transported for alignment and bonding with the supravalvular and subvalvular tissues, the transcatheter artificial bioreceptor valve is transported and released into the anchor stent of the transcatheter bioreceptor valve, and the transcatheter bioreceptor valve stent It is deformed Transcatheter artificial biorecirculating valve The functional state is expanded, and the anchor stent of the ring valve is deformed again and expanded Transcatheter artificial biorecirculating valve Simultaneously with the bonding, the anchor stent of the transcatheter ring valve is deformed again, and anchored by re-bonding the anchor stent to the subvalvular tissue.

[0011] Referring to Figures 7-13, the anchor stent of the transcatheter intercircular valve is one of the main components of the transcatheter intercircular valve system of the present invention, and is an umbrella-shaped stent structure, including an atrial surface 11, a ventricular surface 12, and a connection portion 13 between the two for the anchor stent, wherein the atrial surface is umbrella-like and matches the true form reconstructed three-dimensionally based on the patient's atrial surface image data, i.e., a first lattice portion, and the ventricular surface is a positioning hook loop 121, of which there are two, and the patient Mitral valve The two lobes ( Mitral valve repair ring) perform precise alignment matching with the boundary position, or there are three, and the three lobes of the tricuspid valve (tricuspid Valve repair ring Precise positional matching is performed with respect to the boundary position of the anchor stent, and the connection portion of the anchor stent is round-mouthed funnel-shaped and has a second lattice portion. The first anchor state of the connection portion of the intercatheter valve anchor stent is the first state after being transported and released via the catheter, and is the external fixed-form memory state of the stent, and the fixed-form memory state from the atrial surface to the ventricular surface of the connection portion has a contraction gradient, the gradient being 5 to 45 degrees, and the connection portion of the anchor stent deforms from the first anchor state to a cylindrical second anchor state by deformation and expansion. In the first anchor state of the transcatheter Lubuin ring anchor stent, the positioning hook loop is released from the atrial surface of the intercatheter valve anchor stent via the catheter and matches with the patient Mitral valve Alternatively, it is inserted at the valve leaflet boundary of the tricuspid valve, ensuring that the atrial surface of the positioning anchor stent matches the morphology of the patient's atrium, and in the second anchor state after deformation of the transcatheter ring valve anchor stent, the outer circumference of the connection between the positioning hook loop and the anchor stent is Valve repair ring It is filled between the internal and transcatheter ring valve junction. In the second anchoring state, the positioning hook loop is previously implanted Valve repair ring It fills the eccentric region and is implanted in front of the central axis of the connection part of the anchor stent of the ring valve. Valve repair ring The center is made coaxial. The ventricular surface of the interring valve anchor stent has multiple anchor hook loops that extend from the connection to the ventricular surface and then fold back to match the true subvalvular tissue morphology, which is reconstructed three-dimensionally based on subvalvular imaging data of the patient's dysfunctional valve. In the first anchoring state of the interring valve anchor stent, the anchor hook loops are released through the catheter and then return to the patient's dysfunctional valve. Valve repair ringAligned with the subvalvular tissue, in the second anchoring state of the interring valve anchor stent, the plurality of anchor hook loops deform to form a clamping portion by the combined force of the atrial surface and connection portion of the interring valve anchor stent, and the plurality of deformed anchor hook loops and the patient's dysfunction Valve repair ring It is tightly bound by confluence with the lobes and sublobe tissues.

[0012] The morphology and coverage area of ​​the atrial surface of the transcatheter interventricular valve anchor stent, as well as the morphology, number, length, angle, and structural relationship of the ventricular surface and anchor hook loops 122 of the anchor stent, are all determined by correlating the true structure of the patient's atrium (supravalvular) and ventricle (subvalvular) after three-dimensional reconstruction (3mensio) based on the patient's individual preoperative CT image data, with the true size of each diameter limiting structure measured using three-dimensional ultrasound images. Based on this, the fabrication drawings for the transcatheter interventricular valve anchor stent are designed, and finally, individual interventricular valve anchor stents are customized and manufactured by laser cutting and three-dimensional shaping of specific nickel-titanium memory alloy tubing.

[0013] Based on the true data of the patient's unique images, the anchor stent for the intercircular valve was fabricated and manufactured in the pre-grasp state of the stent, i.e., the stent was not connected via the catheter. Valve repair ring This is also the first anchoring state after being transported internally and released. In the second anchoring state of the transcatheter ring valve anchor stent, Transcatheter artificial biorecirculating valve It is transported into the anchor stent via a catheter and expanded with the assistance of a balloon. Transcatheter artificial biorecirculating valve As it expands, the anchor stent of the ring valve deforms from the first anchor state to the second anchor state, and the deformation force of the stent Transcatheter artificial biorecirculating valve The balloon expansion force integrates with the anchor hook loop 122 on the ventricular surface of the anchor stent, which is simultaneously positioned and inserted subvalvularly, and automatically adaptively aligns itself with the cardiac expansion process, connecting to the chordal space and the valve lobes. Transcatheter artificial biorecirculating valveUnder the action of the balloon expansion force, the anchor stent deforms from the first anchor state to the second anchor state, further tightening its connection with the chordae tendineae and subvalvular tissue to achieve the final anchor. Simultaneously, in the first anchor state of the anchor stent, the atrial-side fixing support rod 111 of its connection structure, as it deforms into the second anchor state, surrounds the axis and becomes parallel to the axial direction, and through the combined force of the end of the fixing support rod and the bent hook 112 at the ventricular end of the connection, it catches on the support rods at both ends of the transcatheter interventricular valve stent, and such an anchor stent and Transcatheter artificial biorecirculating valve The automatic engagement structure at both ends is within the transcatheter ring. valve The anchor stent is precisely joined and integrated, Transcatheter artificial biorecirculating valve Ensure zero displacement.

[0014] The transcatheter ring valve system according to the present invention, which allows for separate and precise anchoring, has an anchor stent attached to the transcatheter artificial biological ring valve, stent The structure comprises a cobalt-chromium alloy stent that serves only for the rational support of three lobes and becomes cylindrical after being compressed radially and expanded by a balloon, or a nickel-titanium alloy stent that becomes cylindrical after being compressed radially and self-expanding, and three fan-shaped lobes provided inside the stent, each of the three fan-shaped lobes having a free edge, an arc-shaped base, and lobe boundary connections extending on both sides, and the stent is graspable in various forms, such as a metal net tube or with the three lobe boundaries fixed. stent That is the case. stent These are cobalt-based alloys, cobalt or chromium alloys, or nickel-titanium alloys.

[0015] The separate-component, precise-anchoring transcatheter ring valve system of the present invention further includes a transport assembly, the transport assembly comprising a transport kit for the anchor stent of the transcatheter ring valve and Transcatheter artificial biorecirculating valveThe transport kit includes a transport kit for the anchor stent of the transcatheter intercircular valve, the transport kit for the anchor stent of the transcatheter intercircular valve includes a transport catheter and a loader for the anchor stent of the transcatheter intercircular valve. The transport kit for the transcatheter bioprosthetic intercircular valve includes a transport device for the transcatheter bioprosthetic intercircular valve, a guide sheath, a valve gripper and a charge pump. The transport device for the anchor stent of the transcatheter intercircular valve and the transport device for the transcatheter bioprosthetic intercircular valve are transported via the femoral vein interatrial septum, apical puncture or left atrial puncture route. Mitral valve Patients after reconstructive surgery Mitral valve ViR treatment may be performed for inactivation of the tricuspid valve, and may be approached via the inferior vena cava through the femoral vein, or via the superior vena cava entry via the jugular vein or subclavian vein for tricuspid valve dysfunction in patients after tricuspid valve repair.

[0016] The contents of the present invention can be summarized as follows: (1) Design of a separate anchor stent, Transcatheter artificial biorecirculating valve (2) Preoperative individual Valve repair ring Based on image data of the supravalvular and subvalvular structures, the three-dimensional true morphology and structure are reconstructed to individually design, fabricate, and manufacture anchor stents of specific morphologies and structures. (3) Using the boundaries of the valve lobes, a dedicated positioning hook loop is used to precisely position the atrial surface of the anchor stent, eliminating irregularities. Valve repair ring The inner edge is filled to artificially construct a regular circular anchor support structure. (4) Transcatheter artificial biorecirculating valve It is approached in the first anchor state and released into the anchor stent. Transcatheter artificial biorecirculating valve The balloon expansion external force released through deforms the anchor stent into a second anchor state. Transcatheter artificial biorecirculating valve The anchor stent is in the second anchor state. Valve repair ringInternally, it interlocks and integrates as one, while simultaneously firmly grasping the subvalvular tissue again to complete the final stable and regular circular anchor. (5) The deformation of the first state after the anchor stent is released is accompanied by automatic adaptive insertion due to cardiac expansion and contraction, individual anatomical joining, interlocking and clamping, and in the second state, Transcatheter artificial biorecirculating valve but Valve repair ring Through a deformation process that involves surgical interlocking via balloon expansion within the body, Transcatheter artificial biorecirculating valve The release operation achieves automatic precision and zero displacement.

[0017] Specifically, the technical proposals and embodiments adopted by this invention are as follows.

[0018] 1. Mitral valve Examples of positions

[0019] (1) Apical approach (see Figures 17-18)

[0020] 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 internally, release the positioning hook loop, and complete the positioning. The atrial surface of the anchor stent, the stent's connecting structure, and the ventricular surface are sequentially released, and the anchor hook loop on the ventricular surface is aligned and joined. The anchor stent transport equipment is removed, and the pre-loaded stent is returned along its original path. Transcatheter artificial biorecirculating valve After transporting it into the anchor stent, with the assistance of a balloon Transcatheter artificial biorecirculating valve Expand it and deform the anchor stent into a second anchor state, Transcatheter artificial biorecirculating valve This ensures precise connection and simultaneously completes the final anchor by securing it to the subvalvular tissue.

[0021] (2) Approach the interatrial septum from the right atrium via the femoral vein (see Figures 19-20).

[0022] 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, approaching the atrial septum from the right atrium to treat the patient's dysfunction. Mitral valve The anchor stent is transported internally, the positioning hook loop is released to complete the positioning, the ventricular surface of the anchor stent, the stent's connecting structure, and the atrial surface are released sequentially, and the anchor hook loop on the ventricular surface is aligned and joined, i.e., the first anchor state of the anchor stent. The transport equipment for the anchor stent is removed and loaded along the original path. Transcatheter artificial biorecirculating valve After transporting it into the anchor stent, with the assistance of a balloon Transcatheter artificial biorecirculating valve Expand it and deform the anchor stent into a second anchor state, Transcatheter artificial biorecirculating valve This ensures precise connection with the subvalvular tissue, while simultaneously forming a clamping force with the subvalvular tissue, thus completing the final anchor.

[0023] (3) For the combined approach routes, see Figures 21-22.

[0024] The combined approach is suitable for cases where preoperative imaging analysis reveals a complex cardiac structure and uncertainty regarding the robustness of the anchor connection in the first state of the designed transcatheter anchor stent. The loaded anchor stent is then delivered via an apical approach to the patient's dysfunction. Mitral valve repair ring The anchor stent is transported internally, the positioning hook loop is released and positioned, the atrial surface and connection of the anchor stent are released sequentially, then the ventricular surface of the anchor stent is released to align and connect the anchor hook loop, that is, the anchor stent is pulled without removing the anchor stent transport equipment. Subsequently, simultaneously, the venous pathway with a pre-inserted guidewire is loaded through the atrial septum. Transcatheter artificial biorecirculating valve It is transported into the anchor stent and aided by a balloon. Transcatheter artificial biorecirculating valve Expand it and deform the anchor stent into a second anchor state, Transcatheter artificial biorecirculating valve This ensures precise connection and deforms the anchor stent into a second anchor state, completing the final anchor. Transcatheter artificial biorecirculating valveRemove the transport equipment, confirm that the second anchor state of the anchor stent is in the design state, and remove the transport equipment of the anchor stent after the anchor has become firm.

[0025] In embodiments of transcatheter intercatheter valve systems at the tricuspid valve location, the most common route is transport from the inferior vena cava via the femoral vein to the tricuspid valve location in the right atrium, and in these embodiments, Mitral valve The route is the same as the one described in position (2), from the right atrium via the femoral vein, through the femoral vein-atrial septum, and back to the right atrium via the femoral vein; see Figure 23.

[0026] The transcatheter annular valve system of the present invention has already been implemented in animal experiments and confirmed by those skilled in the art.

[0027] The feasible significance of the present invention is as follows: (1) The separate design is Transcatheter intercircular valve By passing the anchors to a precisely designed anchor stent, it is responsible only for the symmetrical support of the three valve lobes, ensuring a persistent and stable structure necessary to satisfy the symmetry and synchronization of opening and closing of the valve lobes for a transcatheter prosthetic valve. (2) Anchor stent and Transcatheter artificial biorecirculating valve Transplant them to the front and back, Valve repair ring Reconnect tightly inside, Transcatheter artificial biorecirculating valve To ensure zero displacement, and to integrate Transcatheter artificial biorecircular valve The structure avoids difficulties in press-fitting and transport due to its complexity. (3) Based on the true anatomical form and structure reconstructed in three dimensions from preoperative image data, the anchor stent is individually designed, enabling positional discharge and automatic adaptive bonding and clamping with supravalvular and subvalvular tissues, and a regular circular pre-set structure is reconstructed. Transcatheter intercircular valve The anchor was made even more precise. (4) The separate design was previously transplanted. Valve repair ringIt is expected that by improving dysfunction caused by differences in type, form, and structure, it will be able to contribute to the treatment of many complications and obtain better therapeutic effects. (5) The separate-type, precisely anchored transcatheter intra-ring valve system described above accumulates a large amount of relevant data as an independent data unit for each successful completion of the treatment process in which a unique, predetermined intra-ring valve is precisely inserted into the catheter. This includes analysis of relevant data, morphological design and manufacturing of the transcatheter intra-ring valve anchor stent, processing and manufacturing, relevant data acquired throughout the entire transcatheter treatment process, and postoperative progress data. This will progressively realize the smart, commercialization, and large-scale implementation of the separate-type, precisely anchored transcatheter intra-ring valve system in the treatment process.

Claims

1. Includes a separate anchor stent and a transcatheter artificial bio-ring valve, The morphology and structure of the anchor stent are matched to the true structure of the valve repair ring and its supravalvular and subvalvular structures after being three-dimensionally reconstructed based on the patient's imaging data of postoperative valve dysfunction of the previously implanted valve repair ring, and the anchor stent is first transported for release, deformation, and alignment bonding with the supravalvular and subvalvular tissues of the valve repair ring within the patient's dysfunctional valve repair ring. The transcatheter bio-receptor valve is transported into the anchor stent and released, the stent of the transcatheter bio-receptor valve deforms and expands to the functional state of the transcatheter bio-receptor valve, the anchor stent is deformed again to bond with the expanded transcatheter bio-receptor valve, and at the same time the anchor stent is deformed again to anchor by re-bonding with the subvalvular tissue. A transcatheter ring valve system characterized by its separate, precise anchoring capability.

2. The anchor created by the rejoining is a pre-set anchor for achieving a precise, regular circle. A separate, precise anchoring transcatheter ring valve system as described in claim 1.

3. The aforementioned intra-ring valve system further includes a transport assembly, the transport assembly includes a transport kit for an anchor stent and a transport kit for a transcatheter artificial bio-intra-ring valve, the transport kit for the anchor stent includes a transport catheter and a loader for the anchor stent. A separate, precise anchoring transcatheter ring valve system as described in claim 1.

4. The previously implanted valve repair rings are either each type of mitral valve repair ring implanted for each type of pathogenic mitral valve regurgitation, or each type of tricuspid valve repair ring implanted for each type of pathogenic tricuspid valve regurgitation, and the morphology and structure of the anchor stent are precisely matched to the true morphology and anatomical structure reconstructed three-dimensionally based on the type of previously implanted valve repair ring and individualized imaging data of postoperative valve dysfunction, and the anchor stent and transcatheter artificial bioreceptor valve are reintegrated in the body after being approached anteriorly and posteriorly, respectively, and the anchor stent is deformed again by the release of the transcatheter artificial bioreceptor valve to complete a regularly circular pre-set anchor with the lesioned mitral valve or tricuspid valve and subvalvular tissue, and the anchor stent is not affected by the stress of the shape of the previously implanted valve repair ring, achieving permanent stability of a regularly circular anchor. A separate, precise anchoring transcatheter ring valve system as described in claim 1.

5. The aforementioned transcatheter artificial intercircular valves are intercircular mitral valves and intercircular tricuspid valves. A separate, precise anchoring transcatheter ring valve system as described in claim 1.

6. The anchor stent 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 the transcatheter artificial bio-ring valve. In the first anchoring state, after being released through the catheter, the anchor stent deforms to align and join with the supravalvular and supravalvular structures of the patient's valve repair ring. In the second anchoring state, the anchor stent is expanded and secondarily deformed by the catheterized interring valve, binding to the transcatheter bioprosthetic interring valve and simultaneously completing the final anchoring connection with the subvalvular tissue of the patient's dysfunctional valve repair ring. A separate, precise anchoring transcatheter ring valve system as described in claim 1.

7. In the second anchoring state, the transcatheter artificial biorenal valve is delivered into the anchor stent in the first state by the catheter and released by balloon expansion, causing secondary deformation of the anchor stent by the external force of balloon expansion, and becoming integrally coupled with the expanded transcatheter artificial biorenal valve, completing a regular circular pre-set anchor between the anchor stent and the valve leaflet or subvalvular tissue at the patient's mitral valve or tricuspid valve location. The transcatheter ring valve system according to claim 6, characterized by its separate, precise anchoring capability.

8. In the first anchoring state, the anchor stent is processed into a conical funnel shape with a large atrial surface and a small ventricular surface, based on the type, shape, and size of the previously implanted valve repair ring and an anatomical structure reconstructed three-dimensionally based on personalized image data, and the anchor stent, after being delivered and released via catheter, deforms and recovers its shape to precisely correspond to the supravalvular and subvalvular tissues of the patient's dysfunctional mitral or tricuspid valve, achieving personalized alignment, bonding, and clamping, thereby reconstructing a regular circular pre-set structure. In the second anchoring state, within the anchor stent in the first anchoring state, a transcatheter artificial interring valve is approached via a catheter and released by balloon expansion, integrally connecting with the anchor stent. The anchor stent expands from its original conical funnel shape to a cylindrical shape together with the transcatheterized interring valve, and is gripped by secondary deformation that restores its shape to the axis, tightly connecting with the transcatheterized interring valve and simultaneously completing a tight, pre-set anchor to the patient's mitral valve position or tricuspid valve position and subvalvular tissue. The transcatheter ring valve system according to claim 6, characterized by its separate, precise anchoring capability.

9. The three-dimensionally reconstructed true structure is a digital image model or a 3D printing simulation tangible model, and the three-dimensionally reconstructed true structure is a three-dimensional dynamic image of a virtual simulation after digitizing integrated CT, ultrasound, and nuclear magnetic images, and a corresponding 3D printing simulation tangible model. A transcatheter ring valve system capable of separate, precise anchoring according to any one of claims 1 to 3.

10. The anchor stent has an umbrella-shaped stent structure and includes an atrial surface, a ventricular surface, and a connection portion between the two of these, wherein the atrial surface is umbrella-like and matches the true form reconstructed three-dimensionally based on the patient's atrial surface image data, i.e., a first lattice portion, the ventricular surface includes two positioning hook loops precisely pre-set at the valve leaflet boundaries, and the connection portion of the anchor stent is round-mouthed funnel-shaped and has a second lattice portion. The transcatheter ring valve system according to claim 6, characterized by its separate, precise anchoring capability.

11. The first anchor state of the connection portion of the anchor stent is the first state after it has been transported and released via the catheter, and is the fixed shape memory state of the anchor stent outside the body. The fixed shape memory state of the connection portion from the atrial surface to the ventricular surface has a contraction gradient, the gradient being 5 to 45 degrees, and the connection portion of the anchor stent deforms from the first anchor state to a cylindrical second anchor state by deformation and expansion. The transcatheter ring valve system according to claim 10, characterized by its ability to provide a separate, precise anchor.

12. The positioning hook loops are either two in number, for precise alignment matching with the boundary positions of the two lobes (mitral valve repair rings) of the patient's mitral valve, or three in number, for precise alignment matching with the boundary positions of the three lobes (tricuspid valve repair rings) of the tricuspid valve. The transcatheter ring valve system according to claim 10, characterized by its ability to provide a separate, precise anchor.

13. In the first anchoring state of the anchor stent, the positioning hook loop is released from the atrial surface of the anchor stent via a catheter and inserted into the valve leaflet boundary of the patient's mitral or tricuspid valve to match it, thereby ensuring that the atrial surface of the positioning anchor stent matches the morphology of the patient's atrium. In the second anchoring state after deformation of the anchor stent, the outer circumference of the connection between the positioning hook loop and the anchor stent is filled between the valve repair ring and the connection to the transcatheter valve. The transcatheter ring valve system according to claim 10, characterized by its ability to provide a separate, precise anchor.

14. In the second anchoring state, the positioning hook loop is filled into the eccentric region of the previously implanted valve repair ring, making the central axis of the anchor stent connection coaxial with the center of the previously implanted valve repair ring. The transcatheter ring valve system according to claim 13, characterized by its ability to provide a separate, precise anchor.

15. The ventricular surface of the anchor stent has multiple anchor hook loops that extend from the connection point to the ventricular surface and then fold back, matching the morphology of the true subvalvular tissue, which is reconstructed three-dimensionally based on subvalvular imaging data of the patient's dysfunctional valve. The transcatheter ring valve system according to claim 10, characterized by its ability to provide a separate, precise anchor.

16. In the first anchoring state of the anchor stent, the anchor hook loops are released via the catheter and then aligned with the subvalvular tissue of the patient's valve repair ring. In the second anchoring state of the anchor stent, the plurality of anchor hook loops deform to form a clamping portion through the combined force of the atrial surface and connection portion of the anchor stent, and are tightly coupled by the confluence of the plurality of deformed anchor hook loops with the valve lobes and subvalvular tissue of the patient's valve repair ring. The transcatheter ring valve system according to claim 15, characterized by its ability to provide a separate, precise anchor.

17. The aforementioned anchor hook loops number from 2 to 9. The transcatheter ring valve system according to claim 16, characterized by its ability to provide a separate, precise anchor.

18. The atrial-facing end of the connection portion of the anchor stent is provided with a plurality of fixing support rods or stent bends for inserting the anchor stent, and the fixing support rods or stent bends extend axially along the direction of the atrial surface, with their ends bending toward the axis of the anchor stent. The transcatheter ring valve system according to claim 10, characterized by its ability to provide a separate, precise anchor.

19. The connection portion of the anchor stent is provided with multiple terminal centripetal hooks for inserting the outflow end of the anchor stent. Multiple fixing support rods or bends are positioned above and below the atrial surface end of the connection portion between these centripetal hooks and the anchor stent, surrounding the anchor stent and forming a fitted and integrated connection with the anchor stent, thereby achieving zero displacement during the release of the transcatheter artificial bio-ring valve. The transcatheter ring valve system according to claim 10, characterized by its ability to provide a separate, precise anchor.

20. The aforementioned fixed support rods or stent bends number 3 to 12. A separate, precise anchoring transcatheter ring valve system as described in 19.

21. The first and second lattice portions of the anchor stent are formed by a unit lattice consisting of compressible rhombic lattices, V-lattices, and / or hexagonal or polygonal lattices, and the first and second lattice portions are adaptively connected. The transcatheter ring valve system according to claim 10, characterized by its ability to provide a separate, precise anchor.

22. The distance between the outer edge of the first lattice portion and the patient's atrial wall is 1 to 2 mm. The transcatheter ring valve system according to claim 10, characterized by its ability to provide a separate, precise anchor.

23. The diameter of the inner periphery of the second lattice portion matches the outer diameter of various corresponding sizes of transcatheter artificial bio-ring valves. The transcatheter ring valve system according to claim 10, characterized by its ability to provide a separate, precise anchor.

24. The surface of the anchor stent is coated with a thin film of medical polymer. A transcatheter ring valve system capable of separate, precise anchoring according to any one of claims 1 to 3.

25. The atrial surface, ventricular surface, and connection portion of the anchor stent are either a three-dimensional fabricated structure formed after laser integral cutting or a separate joint structure. A transcatheter ring valve system capable of separate, precise anchoring according to any one of claims 1 to 3.

26. The anchor stent is made of a metallic or non-metallic material having shape memory properties that allow it to recover its shape, and the anchor stent is made of a nickel-titanium alloy. A transcatheter ring valve system capable of separate, precise anchoring according to any one of claims 1 to 3.

27. ​​The stent of the transcatheter artificial biorenal valve is a cobalt-chromium alloy stent that is cylindrical after being compressed radially and expanded by a balloon, or a nickel-titanium alloy stent that is cylindrical after being compressed radially and self-expanded, and the inside of the stent of the transcatheter artificial biorenal valve is provided with three fan-shaped valve leaves, each of the three fan-shaped valve leaves having a free edge, an arc-shaped base, and valve leaf boundary connecting portions extending on both sides, and the stent is a metal net tube. A separate, precise anchoring transcatheter ring valve system as described in claim 1.

28. The stent of the transcatheter artificial bio-ring valve is made of a cobalt-based alloy, cobalt, chromium, or nickel-titanium alloy. The transcatheter ring valve system according to claim 22, characterized by its ability to provide a separate, precise anchor.

29. The transport device for the anchor stent and the transport device for the transcatheter artificial intercircular valve are transported to the tricuspid valve via the inferior vena cava through the femoral vein, or via the superior vena cava through the jugular vein or subclavian vein to the tricuspid valve location, and to the mitral valve via the apical approach, left atrial approach, or femoral vein-atrial septal approach to the mitral valve location. A transcatheter ring valve system capable of separate, precise anchoring, as described in claim 1 or 2.

30. Each time a transcatheter artificial bioreceptor valve treatment process is completed, enabling precise molding and anchoring for a single individualized pre-configuration, a large amount of individualized data is accumulated as independent data units for the parameter data of all individualized transcatheter interring valve systems. Big data algorithms and AI are then used to realize the intelligent, large-scale, and industrialization of the transcatheter interring valve system capable of precise anchoring for each individualized system. A transcatheter ring valve system capable of separate, precise anchoring, as described in claim 1 or 2.

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