A separate, precisely anchored transcatheter annular valve system

Abstract

A separate, precisely anchorable transcatheter annular valve system includes a separate transcatheter annular valve anchor stent (10) and a transcatheter prosthetic biological annular valve (20), the configuration and structure of the transcatheter annular valve anchor stent (10) being similar to that of a previously implanted prosthetic annular valve. Valvuloplasty rings (30) After three-dimensional reconstruction based on the image data of a patient with postoperative valvular dysfunction. Valvuloplasty rings and matching the true structure of the supravalve and subvalvular valve, the transcatheter annular valve anchor stent (10) is first Valvuloplasty rings release, deformation, and dysfunction within Valvuloplasty rings The transcatheter annular valve prosthesis (20) is delivered into the transcatheter annular valve anchor stent (10) for alignment and attachment with the supravalvular and subvalvular tissues, and the transcatheter annular valve prosthesis (20) is delivered and released, and the transcatheter annular valve prosthesis (20) is stents is transformed Transcatheter artificial biological valve The valve was expanded to its functional state, and the valve anchor stent (10) was deformed again to expand the valve. Transcatheter artificial biological valve At the same time, the transcatheter annular valve anchor stent (10) is deformed again, and the transcatheter annular valve anchor stent (10) is anchored by being reconnected to the subvalvular tissue.

Description

[Technical Field]

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

[0002] The weighted prevalence of valvular heart disease in China is estimated at 3.8%, meaning there are approximately 25 million patients with valvular disease in China (BMC Cardiovasc Disord. 2021, 21: 339). Most of the patients in China who require treatment are 65 years old or younger, so artificial valve replacement by valvular surgery and repair by valvular plastic surgery should be the main treatment method for a considerable period of time to come. The former requires the insertion of an artificial heart valve, and the latter requires Valvuloplasty rings The patient will need to have a tricuspid valve replacement in 2021 to complete the repair. Plastic Surgery Ring Approximately 26,000 mitral valves Plastic Surgery Ring The total number of valves used is estimated at about 14,000, and the cumulative number of valves used has already significantly exceeded the number of artificial biological valves, with a double-digit increase each year. Furthermore, the time for widespread adoption and widespread use of valvular repair in China and the accumulation of surgical experience are limited, and the rate of degenerative changes in the valves is particularly lower than in Western countries. Valvuloplasty rings Patients who undergo valvular repair surgery, including implantation of a valve, inevitably face the challenge of valve repair at an advanced age, requiring transcatheter annular valve (ViR) treatment.

[0003] According to numerous sources, Valvuloplasty rings Due to differences in material, structure, and shape (Figure 1), it has been reported that compared with transcatheter annular valves (ViVs), ViRs have significantly lower postoperative complications, mid-term postoperative annular valve function, and quality of life. Researchers have concluded that these problems with ViRs are primarily due to the fact that the annular valves have been implanted previously. Valvuloplasty rings This is thought to be due to deformation after implantation of the ViR due to irregularities in the material, shape, and structure of the valve, and to the inevitable increase in perivalvular leakage. Therefore, the present invention provides a separate transcatheter annular valve system design. Summary of the Invention

[0004] The present invention has been previously Mitral valve repair ring or tricuspid Valvuloplasty rings The purpose of the present invention is to provide a stable and accurate transcatheter anchor for the balloon-expanded annular valve by installing a stable and regular circular support structure within the annular valve. The transcatheter annular valve system of the present invention is composed of two parts: a transcatheter annular valve anchor stent and a transcatheter prosthetic biological annular valve. The core of the invention is to provide a three-dimensional image of the annular valve after it has been three-dimensionally reconstructed based on the preoperative personalized image data. Valvuloplasty rings Based on the true anatomy of the supravalvular and infravalvular Valvuloplasty rings One system can be customized to fit the shape, structure and size of the product, and positioning and ejection are performed. Valvuloplasty rings The valve is automatically adapted to the prosthetic tissue within the stent, achieving progressive engagement and clamping with the supravalvular and subvalvular tissues, and then the prosthetic tissue valve is delivered into the anchored valve stent via a catheter and released by balloon expansion, thereby Transcatheter artificial biological valve The central axis of the connecting part of the anchor stent is connected to the previously implanted Valvuloplasty rings By being coaxial with the center of Transcatheter artificial biological valve It achieved accurate anchoring and achieved therapeutic effects similar to or superior to those of ViV.

[0005] A specific technical solution of the present invention is a separate, precisely anchored transcatheter annular valve system, which includes a separate transcatheter annular valve anchor stent and a transcatheter prosthetic biological annular valve, and the shape and structure of the transcatheter annular valve anchor stent are similar to those of a previously implanted prosthetic annular valve. Valvuloplasty rings After three-dimensional reconstruction based on the patient's image data due to postoperative valvular dysfunction Valvuloplasty rings The transcatheter annular valve anchor stent is first inserted to identify the patient's dysfunction and then matched to the true supravalvular and infravalvular structures. Valvuloplasty rings release, deformation, and dysfunction within Valvuloplasty ringsthe transcatheter annular valve is delivered into and released from an anchor stent of the transcatheter annular valve for alignment and attachment with the supravalvular and subvalvular tissues, and the transcatheter annular valve is delivered into and released from an anchor stent of the transcatheter annular valve for alignment and attachment with the supravalvular and subvalvular tissues. stents is transformed Transcatheter artificial biological valve The valve was expanded to its functional state, and the anchor stent of the valve was deformed again to expand the valve. Transcatheter artificial biological valve At the same time, the anchor stent of the transcatheter annular valve is deformed again to reconnect the anchor stent to the subvalvular tissue for anchoring.

[0006] Furthermore, the anchors by reconnection are preset anchors to achieve an accurate regular circular shape. The intra-annular valve system further includes a delivery assembly, the delivery assembly including a delivery kit for a transcatheter intra-annular valve anchor stent and Transcatheter artificial biological valve The transcatheter annular valve anchor stent delivery kit includes a delivery catheter and a transcatheter annular valve anchor stent loader. Valvuloplasty rings The etiology of each type Mitral valve Various types of implants for closure failure Mitral valve repair ring or various types of tricuspid valve repair annuli implanted for various types of pathological tricuspid regurgitation, and the shape and structure of the transcatheter annular valve anchor stent are similar to those of the previously implanted tricuspid valve repair annuli. Valvuloplasty rings The transcatheter annular valve anchor stent and the transcatheter prosthetic annular valve are reintegrated into the body after being approached from the front and back, and the transcatheter annular valve anchor stent is deformed again by the release of the transcatheter valve, thereby correcting the lesion. Mitral valve Or complete a regular circular pre-setting anchor with the tricuspid valve and subvalvular tissue, and the valve anchor in the transcatheter prosthetic annulus was previously implanted. Valvuloplasty rings The transcatheter annular valve is not affected by the stress of the shape of the annulus, and can achieve permanent stability of the regular circular anchor. Valvuloplasty rings Medium Mitral valveand Valvuloplasty rings The transcatheter annular valve anchor stent has a compressed state in which the stent is placed in a catheter, and a first anchor state after being released through the catheter. Transcatheter artificial biological valve and a second anchoring state after the annulus valve anchor stent is coupled to the catheter, wherein in the first anchoring state, the annulus valve anchor stent is released through the catheter and then released to the patient's dysfunction. Valvuloplasty rings and in the second anchoring state, the annular valve anchor stent is expanded by the catheterized annular valve to undergo a secondary deformation. Transcatheter artificial biological valve At the same time, the patient's dysfunction Valvuloplasty rings In the second anchoring state, the transcatheter annular valve is delivered by a catheter into the anchor stent of the transcatheter annular valve in the first state and released by balloon expansion, and the external force of the balloon expansion causes the anchor stent of the annular valve to undergo secondary deformation and be integrally connected with the expanded transcatheter annular valve, thereby completing the final anchor connection with the subvalvular tissue of the patient. Mitral valve In the first anchoring state, the transcatheter annular valve anchor stent completes a regular circular pre-setting anchor with the valve leaflet or subvalvular tissue at the tricuspid valve position. Valvuloplasty rings Based on the type, shape, and size of the stent and the anatomical structure reconstructed three-dimensionally based on the personalized image data, the stent is processed into a conical funnel shape with a large atrial surface and a small ventricular surface, and the transcatheter annular valve anchor stent is delivered through a catheter and released, and then deforms and recovers its shape to prevent the patient's dysfunction. Mitral valveOr, it accurately corresponds to the supravalvular and subvalvular tissues of the tricuspid valve to realize individualized alignment and clamping, and re-establish a regular circular preset structure. In the second anchoring state, in the first anchoring state, the transcatheter annular valve anchor stent is approached through a catheter and released by balloon inflation, and is integrally combined with the transcatheter annular valve anchor stent. The transcatheter annular valve anchor stent expands from its original conical funnel shape to a cylindrical shape together with the transcatheterized annular valve, and is clamped by the shape recovery to the axis due to secondary deformation, and is tightly combined with the transcatheterized annular valve, while at the same time providing the patient with a comfortable and safe environment. Mitral valve Position or tricuspid valve position and tight pre-setting anchor with subvalvular tissue is completed.

[0007] Furthermore, the three-dimensionally reconstructed true structure is a digital image model or a 3D printed simulation solid model, and the three-dimensionally reconstructed true structure is a virtual simulation three-dimensional dynamic image after digitizing and converting an integrated image of CT, ultrasound, and nuclear magnetic resonance, and a corresponding 3D printed simulation solid model. The mid-annular valve anchor stent is an umbrella-shaped stent structure, including an atrial surface, a ventricular surface, and a connecting portion of the anchor stent between them, the atrial surface is umbrella-shaped and has an umbrella-shaped first lattice portion that matches the three-dimensionally reconstructed true shape based on the image data of the atrial surface of the patient, the ventricular surface has two positioning hook loops that are accurately preset at the boundary positions of the valve leaflets, and the connecting portion of the anchor stent is round-mouthed funnel-shaped and has a second lattice portion. The first anchor state of the connecting portion of the anchor stent of the annular valve is a first state after being delivered and released through a catheter, which is a fixed shape memory state of the stent outside the body, and the fixed shape memory state of the connecting portion from the atrial surface to the ventricular surface has a contraction gradient, the gradient is 5 to 45 degrees, and the connecting portion of the anchor stent is transformed from the first anchor state to a cylindrical second anchor state by deformation and expansion. There are two positioning hook loops, Mitral valve The two leaflets ( Mitral valveor three leaflets of the tricuspid valve ( Mitral valve repair ring In the first anchoring state of the transcatheter valve-in-annulus anchor stent, the positioning hook loop is released from the atrial surface of the valve-in-annulus anchor stent through the catheter, and the patient's heart is matched to it. Mitral valve or inserted into the tricuspid valve leaflet boundary position to ensure that the atrial surface of the positioning anchor stent matches the shape of the patient's atrium; and in the second anchor state after deformation of the transcatheter annular valve anchor stent, the outer circumference of the connection part between the positioning hook loop and the anchor stent is: Valvuloplasty rings Inside and Transcatheter artificial biological valve In the second anchor state, the positioning hook loop is filled between the previously implanted Valvuloplasty rings The eccentric region of the annulus is filled with the central axis of the connection of the anchor stent to the valve in the annulus and the previously implanted Valvuloplasty rings The ventricular surface of the anchor stent of the annular valve has a plurality of anchor hook loops, which extend from the connecting portion to the ventricular surface and then turn back, so as to prevent dysfunction of the patient. Valvuloplasty rings The morphology of the true subvalvular tissue is three-dimensionally reconstructed based on the subvalvular image data. In the first anchoring state of the intra-annular valve anchor stent, the anchor hook loop is released through the catheter and then inserted into the patient's dysfunctional anatomy. Valvuloplasty rings In the second anchor state of the annular valve anchor stent, the plurality of anchor hook loops are deformed to form a clamping portion by the action of a resultant force of the atrial surface and the connecting portion of the annular valve anchor stent, and the plurality of deformed anchor hook loops and the dysfunction of the patient are connected to each other. Valvuloplasty ringsThe annular valve is tightly connected to the valve leaflets and the subvalvular tissue by intertwining with them. The number of the anchor hook loops is 2 to 9, preferably 4 to 6. The end of the connecting portion of the annular valve anchor stent on the atrial surface is provided with a plurality of fixed support rods or stent bends for inserting a transcatheter annular valve stent, and the fixed support rods or stent bends extend axially along the atrial surface, with their ends bent toward the axis of the anchor stent. The connecting portion of the annular valve anchor stent is provided with a plurality of terminal centripetal hooks for inserting the outflow end of the transcatheter annular valve stent, and the end of the connecting portion of the annular valve anchor stent and these centripetal hooks are provided with a plurality of fixed support rods or bends for inserting the atrial end of the transcatheter annular valve stent, surrounding them from above and below, forming an engagement with the anchor stent and being integrated. Transcatheter artificial biological valveThe fixed support rod or stent has 3 to 12 bends, preferably 6 to 9. The first and second lattice portions of the anchor bolt for the annular valve are formed by unit lattices consisting of compressible diamond lattices, V lattices, and / or hexagonal or polygonal lattices, and the first and second lattice portions are adaptively connected. The distance between the outer periphery of the lattice portion on the atrial surface and the patient's atrial wall is 1 to 2 mm, preferably 1.5 mm. The diameter of the inner periphery of the second lattice portion matches the outer diameters of various corresponding sizes of transcatheter prosthetic annular valves. The surface of the anchor stent for the annular valve is coated with a single layer of a medical polymer thin film. The connection portions of the atrial surface, ventricular surface, and anchor stent of the anchor stent for the annular valve are three-dimensionally shaped structures formed by laser cutting or separately joined structures. The anchor stent is a metallic or non-metallic material with shape memory properties that allows it to recover its shape, and the anchor stent is made of a nickel-titanium alloy material. The transcatheter prosthetic annular valve includes a cobalt-chromium alloy stent that assumes a cylindrical shape after being radially compressed and expanded by a balloon, or a nickel-titanium alloy stent that assumes a cylindrical shape after being radially compressed and self-expanded, and three fan-shaped leaflets disposed inside the stent, each of which has a free edge, an arc-shaped base, and leaflet boundary connections extending on both sides, and the stent is a metallic net tube. stents is a cobalt-based alloy, a cobalt or chromium alloy, or a nickel-titanium alloy. The transcatheter annular valve anchor stent delivery device and the prosthetic biological annular valve delivery device are delivered to the tricuspid annular valve via the femoral vein from the inferior vena cava, or via the jugular vein or subclavian vein from the superior vena cava to the tricuspid valve position; Mitral valve For the annular valve, the apical approach, left atrial approach, or femoral vein atrial septal approach Mitral valve is transported to the location.

[0008] In the present invention, precise shaping and anchoring for a single individual preset is achieved. Transcatheter artificial biological valve Each time a treatment process is completed, all of the above related data are treated as independent data units, and a large amount of personalized data is accumulated. By using big data algorithms and AI, the separate, precise anchoring transcatheter annular valve system can be made intelligent, large-scale, and industrialized. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a diagram of different types of mitral and tricuspid annuloplasty rings implanted in the prior art. [Figure 2] FIG. 2 shows various molding rings in the prior art. [Figure 3] 3A-B are schematic diagrams illustrating the implantation of a transcatheter annular valve system according to an embodiment of the present invention. [Figure 4] FIG. 4 is a schematic diagram illustrating implantation of a transcatheter annular valve system according to an embodiment of the present invention. [Figure 5] FIG. 5 is a schematic diagram illustrating implantation of a transcatheter annular valve system according to an embodiment of the present invention. [Figure 6] FIG. 6 is a schematic diagram of a transcatheter annular valve system according to an embodiment of the present invention. [Figure 7] FIG. 7 is a schematic diagram of an anchor stent for a transcatheter annular valve according to an embodiment of the present invention. [Figure 8] FIG. 8 is a schematic diagram of a different type of transcatheter annular valve anchor stent according to an embodiment of the present invention. [Figure 9] FIG. 9 is a schematic diagram of a different type of transcatheter annular valve anchor stent according to an embodiment of the present invention. [Figure 10] FIG. 10 is a schematic diagram of a different configuration of a transcatheter annular valve anchor stent according to an embodiment of the present invention. [Figure 11B] 11A-B are schematic diagrams of fixed support bars and centripetal bending of an anchor stent according to an embodiment of the present invention. [Figure 12]12A-C are schematic diagrams of an anchor stent of a transcatheter annular valve according to an embodiment of the present invention in a first anchoring state. [Figure 13] 13A-C are schematic diagrams of a second anchoring state of an anchor stent of a transcatheter annular valve according to an embodiment of the present invention. [Figure 14] FIG. 14 is a schematic diagram of the anchor hook loop and secondary anchor of the chordae tendineae after the transcatheter mitral valve anchor stent according to an embodiment of the present invention is implanted in a human body. [Figure 15] FIG. 15 is a schematic diagram of a transcatheter prosthetic biological annular valve according to an embodiment of the present invention. [Figure 16] FIG. 16 is a schematic diagram of a transportation system according to an embodiment of the present invention. [Figure 17] 17A-E are schematic illustrations of a process of approaching a transcatheter annular valve anchor stent via an apical approach according to an embodiment of the present invention. [Figure 18] 18A-C are schematic illustrations of a process of approaching a mid-annular valve anchor stent via an apical approach according to an embodiment of the present invention. [Figure 19] 19A-D are schematic diagrams illustrating the process of approaching an anchor stent for the atrial septal annulus valve via a femoral vein access according to an embodiment of the present invention. [Figure 20] 20A-C are schematic diagrams illustrating a process of approaching and delivering an anchor stent to a transcatheter prosthetic valve in the atrial septum via a femoral vein access according to an embodiment of the present invention. [Figure 21] 21A-C are schematic diagrams illustrating a process of approaching an anchor stent of a transcatheter annular valve via a combined route according to an embodiment of the present invention. [Figure 22] 22A-D are schematic illustrations of a process for delivering a transcatheter annular valve anchor stent via a combined route according to an embodiment of the present invention. [Figure 23] 23A-F are schematic diagrams of a tricuspid valve position transcatheter valve system according to an embodiment of the present invention, including a transcatheter annular valve. [Figure 24]24A-B are schematic illustrations of positioning hook loops of an anchor stent according to an embodiment of the present invention filling an eccentric region of a previously implanted annuloplasty ring. DETAILED DESCRIPTION OF THE INVENTION

[0010] 3-6, the separate, precisely anchorable transcatheter annular valve system of the present invention includes a separate transcatheter annular valve anchor stent 10 and a transcatheter prosthetic biological annular valve 20, the configuration and structure of which are similar to those of a previously implanted transcatheter annular valve anchor stent. Valvuloplasty rings Three-dimensional reconstruction based on image data from 30 patients with postoperative valvular dysfunction Valvuloplasty rings The transcatheter annular valve anchor stent is first inserted to identify the patient's dysfunction and then matched to the true supravalvular and infravalvular structures. Valvuloplasty rings release, deformation, and dysfunction within Valvuloplasty rings the transcatheter annular valve is delivered into and released from an anchor stent of the transcatheter annular valve for alignment and attachment with the supravalvular and subvalvular tissues; stents is transformed Transcatheter artificial biological valve The valve was expanded to its functional state, and the anchor stent of the valve was deformed again to expand the valve. Transcatheter artificial biological valve At the same time, the anchor stent of the transcatheter annular valve is deformed again to reconnect the anchor stent to the subvalvular tissue for anchoring.

[0011] 7 to 13, the anchor stent of the transcatheter annular valve is one of the main components of the transcatheter annular valve system of the present invention, and has an umbrella-type stent structure, including an atrial surface 11, a ventricular surface 12, and a connecting portion 13 of the anchor stent between them. The atrial surface is an umbrella-like cloth-like first lattice portion that matches the true shape three-dimensionally reconstructed based on image data of the atrial surface of the patient, and the ventricular surface is a positioning hook loop 121, and two positioning hook loops 122, which are connected to the atrial surface of the patient. Mitral valve The two leaflets ( Mitral valve repair ring) or three leaflets of the tricuspid valve ( Valvuloplasty rings ) and accurately aligns and matches the boundary position of the annular valve anchor stent, and the connecting portion of the anchor stent is round-nosed funnel-shaped and has a second lattice portion. The first anchor state of the connecting portion of the annular valve anchor stent is a first state after being delivered and released via a catheter, and is a fixed shape memory state outside the body of the stent, and the fixed shape memory state from the atrial surface to the ventricular surface of the connecting portion has a contraction gradient, the gradient being 5 to 45 degrees, and the connecting portion of the anchor stent is transformed from the first anchor state to a cylindrical second anchor state by deformation and expansion. In the first anchor state of the transcatheter vein-in annular anchor stent, the positioning hook loop is released from the atrial surface of the annular valve anchor stent via a catheter and matches it to the patient's annular valve anchor stent. Mitral valve or inserted into the tricuspid valve leaflet boundary position to ensure that the atrial surface of the positioning anchor stent matches the shape of the patient's atrium; and in the second anchor state after deformation of the transcatheter annular valve anchor stent, the outer circumference of the connection part between the positioning hook loop and the anchor stent is: Valvuloplasty rings In the second anchoring state, the positioning hook loop is filled between the inner wall and the joint of the transcatheter annular valve. Valvuloplasty rings The eccentric region of the annulus is filled with the central axis of the connection of the anchor stent to the valve in the annulus and the previously implanted Valvuloplasty rings The ventricular surface of the annular valve anchor stent has a plurality of anchor hook loops, which extend from the connection part to the ventricular surface and then turn back, matching the shape of the true subvalvular tissue three-dimensionally reconstructed based on the subvalvular image data of the patient's dysfunctional valve leaflet. In the first anchor state of the annular valve anchor stent, the anchor hook loops are released through the catheter and then folded back on the ventricular surface of the patient's dysfunctional valve leaflet. Valvuloplasty ringsIn the second anchor state of the annular valve anchor stent, the plurality of anchor hook loops are deformed to form a clamping portion by the action of a resultant force of the atrial surface and the connecting portion of the annular valve anchor stent, and the plurality of deformed anchor hook loops and the dysfunction of the patient are connected to each other. Valvuloplasty rings The valve is tightly bound by interlacing leaflets and subvalvular tissue.

[0012] The shape and size of the atrial surface of the transcatheter intraannular valve anchor stent, as well as the shape, number, length, angle and structural relationship of the ventricular surface of the anchor stent and the anchor hook loops 122 are all determined based on the true structure of the patient's atrium (supravalvular) and ventricle (infravalvular) after three-dimensional reconstruction (3mensio) based on the patient's individual preoperative CT image data, and the true sizes of each diameter-limiting structure are matched with the measured true sizes using three-dimensional ultrasound images. A processing drawing for the transcatheter intraannular valve anchor stent is then designed, and a unique, customized intraannular valve anchor stent is finally manufactured by laser cutting and three-dimensional forming a specific nickel-titanium memory alloy tube material.

[0013] According to the true data of the patient's individual image, the anchor stent of the annulus valve is processed and manufactured in the pre-clamped state of the stent, that is, the stent is inserted through the catheter. Valvuloplasty rings The first anchoring state is also the state after the transcatheter annular valve anchor stent is delivered and released into the annulus. Transcatheter artificial biological valve is delivered into the anchor stent via a catheter and expanded with the assistance of a balloon; Transcatheter artificial biological valve The valve anchor stent is expanded, and the valve anchor stent is transformed from the first anchor state to the second anchor state. Transcatheter artificial biological valve The anchor hook loops 122 on the ventricular surface of the anchor stent, which is inserted under the valve and positioned, automatically and adaptively align with the expansion process of the heart and are connected to the chordae tendineae gap and the valve leaflets. Transcatheter artificial biological valveUnder the action of the external force of balloon expansion, the anchor stent transforms from the first anchor state to the second anchor state, and is more tightly coupled with the chordae tendineae and subvalvular tissue to achieve the final anchor. At the same time, in the first anchor state of the anchor stent, the fixed support rod 111 on the atrial side of the connecting structure transforms to the second anchor state, and turns toward the axial center, becomes parallel to the axial direction, and hooks onto the support rods at both ends of the transcatheter annular valve stent through the combined force of the end of the fixed support rod and the bending hook 112 at the ventricular end of the connecting part. Transcatheter artificial biological valve The automatic hooking structure with both ends of the catheter is valve and the anchor stent are precisely combined and integrated. Transcatheter artificial biological valve Ensure zero displacement.

[0014] The separate, precisely anchorable transcatheter annular valve system according to the present invention has an anchor stent connected to the transcatheter prosthetic biological annular valve, so that: stents The structure includes a cobalt-chromium alloy stent that serves only to rationally support the three valve leaflets and assumes a cylindrical shape after being radially compressed and expanded by a balloon, or a nickel-titanium alloy stent that assumes a cylindrical shape after being radially compressed and self-expanded, and three fan-shaped valve leaflets provided inside the stent, each of which has a free edge, an arc-shaped base, and leaflet boundary connections extending to both sides. The stent can be grasped in various forms, such as a metal net tube or a stent with the three leaflet boundaries fixed. stents is. stents is a cobalt-based alloy, a cobalt or chromium alloy or a nickel titanium alloy.

[0015] The separate, precisely anchorable transcatheter annular valve system of the present invention further includes a delivery assembly, the delivery assembly including a transcatheter annular valve anchor stent delivery kit and Transcatheter artificial biological valveThe transcatheter annular valve anchor stent delivery kit includes a delivery catheter and a transcatheter annular valve anchor stent loader. The transcatheter annular valve prosthesis delivery kit includes a transcatheter annular valve prosthesis delivery device, a guide sheath, a valve leaflet gripper, and a charge pump. The transcatheter annular valve anchor stent delivery device and the transcatheter annular valve prosthesis delivery device are delivered via the femoral vein, atrial septum, apical puncture, or left atrial puncture route. Mitral valve Patients after plastic surgery Mitral valve ViR treatment may be performed for ineffective tricuspid valve repair in patients with tricuspid valve insufficiency, approached from the inferior vena cava via the femoral vein, or by superior vena cava access via the jugular or subclavian vein.

[0016] The present invention can be summarized as follows: (1) A separate anchor stent design; Transcatheter artificial biological valve The catheter is transported back and forth and then combined in the heart. (2) Preoperative individual Valvuloplasty rings Based on the image data of the valve and the structures above and below the valve, the anchor stent with a specific shape and structure is individually designed, processed, and manufactured based on the three-dimensional true shape and structure reconstructed. (3) Using the boundary of the valve leaflets, the anchor stent's atrial surface is accurately positioned with a dedicated positioning hook loop to prevent irregularities. Valvuloplasty rings Fill the inner edge of the hole to artificially create a regular circular anchor support structure. (4) Transcatheter artificial biological valve is approached in a first anchor state and released into the anchor stent; Transcatheter artificial biological valve The anchor stent is transformed into a second anchor state by a balloon expansion external force released through the Transcatheter artificial biological valve and the anchor stent is in the second anchor state. Valvuloplasty ringsThe anchor stent is then inserted into the valve and securely grips the subvalvular tissue again, completing the final stable and regular circular anchor. (5) After the anchor stent is released, the first state of deformation is accompanied by automatic adaptive insertion, unique anatomical connection, mutual holding and clamping due to cardiac diastolic contraction, and in the second state, Transcatheter artificial biological valve but Valvuloplasty rings By a deformation process in which the surgical fit is performed by balloon expansion within the Transcatheter artificial biological valve The ejection operation is realized to reach automatic accuracy and zero displacement.

[0017] Specifically, the technical solutions and embodiments adopted by the present invention are as follows:

[0018] 1. Mitral valve Example of location

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

[0020] The apical approach route is an embodiment familiar to cardiac surgeons. First, a loaded anchor stent is inserted into the patient's lesion via the apical approach. Mitral valve The anchor stent is transported into the atrial cavity, the stent's connecting structure, and the ventricular surface are sequentially released, and the anchor hook loops on the ventricular surface are aligned and connected. The anchor stent transport device is then removed, and the pre-loaded stent is transported along the original path. Transcatheter artificial biological valve After delivery into the anchor stent, Transcatheter artificial biological valve and expanding the anchor stent to transform the anchor stent into a second anchor state. Transcatheter artificial biological valve This achieves accurate connection with the valve, and at the same time completes the final anchor by fastening with 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 to physicians. A loaded anchor stent is delivered via the femoral vein to the atrial septum from the right atrium to provide a catheter for the patient's dysfunction. Mitral valve The anchor stent is transported into the atrial cavity, and 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 sequentially released, and the anchor hook loop on the ventricular surface is aligned and connected, that is, the first anchor state of the anchor stent. The anchor stent transport device is then removed, and the anchor stent is loaded along the original path. Transcatheter artificial biological valve After delivery into the anchor stent, the balloon is used to Transcatheter artificial biological valve and expanding the anchor stent to transform the anchor stent into a second anchor state. Transcatheter artificial biological valve This achieves precise connection with the valve and simultaneously forms a clamp with the subvalvular tissue, completing the final anchor.

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

[0024] The combined approach is suitable for cases where preoperative imaging analysis indicates a complex cardiac structure and the anchor bond strength of the designed transcatheter anchor stent is uncertain. The loaded anchor stent is then inserted into the patient's dysfunction via the apical approach. Mitral valve repair ring The anchor stent is delivered into the atrial cavity, the positioning hook loop is released to position it, the atrial surface and the connecting part of the anchor stent are sequentially released, and then the ventricular surface of the anchor stent is released to align and connect the anchor hook loop, i.e., the anchor stent is pulled without removing the anchor stent delivery device. Then, the venous route through which the guide wire was previously inserted and the atrial septum are loaded. Transcatheter artificial biological valve The catheter is delivered into the anchor stent and then balloon-assisted Transcatheter artificial biological valve and expanding the anchor stent to transform the anchor stent into a second anchor state. Transcatheter artificial biological valve This achieves precise coupling with the anchor stent and transforms the anchor stent into a second anchor state, completing the final anchor. Transcatheter artificial biological valveThe delivery device for the anchor stent is removed, and the second anchor state of the anchor stent is confirmed to be the designed state. After the anchor has become strong, the delivery device for the anchor stent is removed.

[0025] In the embodiment of the tricuspid position transcatheter annular valve system, the most common route is delivery via the femoral vein from the inferior vena cava to the tricuspid position in the right atrium, and the embodiment is Mitral valve The route is the same as from the right atrium via the femoral vein at location (2), through the femoral vein, the atrial septum, and back to the right atrium via the femoral vein, see FIG. 23.

[0026] The transcatheter annular valve system of the present invention has already been implemented in animal experiments based on the above-mentioned technical solution and has been confirmed by those skilled in the art.

[0027] The feasible meanings of the present invention are as follows: (1) The separate design is Transcatheter annular valve By connecting the anchors to a precisely designed anchor stent, the device is solely responsible for the symmetrical support of the three valve leaflets, ensuring a sustainable and stable structure necessary for the transcatheter prosthetic valve to satisfy the symmetry of the valve leaflets and synchronization of opening and closing. (2) Anchor stent and Transcatheter artificial biological valve Transplant them front and back, Valvuloplasty rings tightly bound again within Transcatheter artificial biological valve Ensure zero displacement and integrate Transcatheter artificial heart valve The complexity of the structure makes it difficult to insert and transport. (3) Based on the true anatomical morphology and structure reconstructed three-dimensionally from preoperative image data, the anchor stent is individually designed and positioned for release, achieving automatic adaptive binding and clamping with the supravalvular and subvalvular tissues, and reconstructing a regular circular pre-set structure. Transcatheter annular valve (4) The separate design was previously transplanted. Valvuloplasty ringsIt is expected to improve dysfunctions caused by different types, shapes, and structures of annular valves, and to be involved in the treatment of many complications, thereby achieving better therapeutic effects. (5) The above-described separate, precisely anchored transcatheter annular valve system accumulates, as an independent data unit, a large amount of relevant data, such as individual image data, design and manufacturing parameters of the anchor stent, the transcatheter treatment process, and postoperative progress data, obtained through the entire process of transcatheter treatment, including analysis of related data, and the shape design, processing, and manufacturing of the transcatheter annular valve anchor stent, thereby gradually realizing smart, commercial, and large-scale transcatheter treatment of the separate, precisely anchored transcatheter annular valve system.

Claims

1. a separate transcatheter annular valve anchor stent and a transcatheter prosthetic annular valve; The shape and structure of the transcatheter annular valve anchor stent are matched to the true supravalvular and subvalvular structures of the annuloplasty ring after three-dimensional reconstruction based on image data of a patient with a postoperative valvular dysfunction of a previously implanted annuloplasty ring, and the transcatheter annular valve anchor stent is first delivered for release, deformation, and alignment and attachment with the supravalvular and subvalvular tissues of the dysfunctional annuloplasty ring in the patient; The transcatheter annular valve is delivered into and released from the anchor stent of the transcatheter annular valve, the stent of the transcatheter annular valve is deformed to expand the transcatheter annular valve into a functional state, the anchor stent of the annular valve is deformed again to connect with the expanded transcatheter annular valve, and at the same time, the anchor stent of the transcatheter annular valve is deformed again to connect with the subvalvular tissue again for anchoring. A separate, precisely anchorable transcatheter annular valve system.

2. The anchors are pre-set anchors to achieve accurate regular circular shapes.

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

3. The annular valve system further includes a delivery assembly, the delivery assembly including a transcatheter annular valve anchor stent delivery kit and a transcatheter biological annular valve delivery kit, the transcatheter annular valve anchor stent delivery kit including a delivery catheter and a transcatheter annular valve anchor stent loader.

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

4. The previously implanted annuloplasty ring is a mitral valve repair ring of various types implanted for various types of pathological mitral regurgitation, or a tricuspid valve repair ring of various types implanted for various types of pathological tricuspid regurgitation, and the shape and structure of the transcatheter annular valve anchor stent accurately match the true shape and anatomical structure three-dimensionally reconstructed based on the type of previously implanted annuloplasty ring and personalized image data of postoperative valvular dysfunction. The transcatheter annular valve anchor stent and the transcatheter annular prosthesis valve are reintegrated in vivo after being approached from the front to the back, and the transcatheter annular valve anchor stent is deformed again by the release of the transcatheter annular prosthesis valve to complete a regular circular pre-set anchor with the diseased mitral valve or tricuspid valve and subvalvular tissue, so that the transcatheter annular valve anchor is not affected by the stress of the shape of the previously implanted annuloplasty ring and achieves permanent stability of the regular circular anchor.

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

5. The transcatheter prosthetic biological annular valve is an annular mitral valve and an annular tricuspid valve.

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

6. the transcatheter annular valve anchor stent has a compressed state disposed within a catheter, a first anchored state after being released through the catheter, and a second anchored state after being coupled to the transcatheter annular valve prosthesis; In the first anchoring state, the annular valve anchor stent, after being released through the catheter, transforms into aligned junction with the supravalvular and subvalvular structures of the patient's dysfunctional valvuloplasty ring; In the second anchoring state, the annular valve anchor stent is expanded by the catheterized annular valve to undergo secondary deformation, and is coupled to the transcatheter prosthetic annular valve while completing a final anchoring connection with the subvalvular tissue of the patient's dysfunctional valvuloplasty ring.

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

7. In the second anchoring state, the transcatheter annular prosthetic valve is delivered by a catheter into the anchor stent of the transcatheter annular valve in the first state and released by balloon expansion, so that the anchor stent of the annular valve is secondarily deformed by the external force of the balloon expansion, and is integrally coupled with the expanded transcatheter annular prosthetic valve, completing a regular circular pre-set anchor between the anchor stent and the valve leaflet or subvalvular tissue at the mitral valve position or tricuspid valve position of the patient.

7. The separate, precisely anchorable transcatheter annular valve system of claim 6.

8. In the first anchoring state, the transcatheter annular valve 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 annuloplasty ring and the anatomical structure three-dimensionally reconstructed based on the personalized image data, and the transcatheter annular valve anchor stent, after being delivered and released through the catheter, deforms and recovers its shape to accurately correspond to the supravalvular and subvalvular tissues of the patient's dysfunctional mitral or tricuspid valve, thereby achieving personalized alignment, coaptation, and clamping, and re-establishing a regular circular preset structure; In the second anchoring state, within the transcatheter annular valve anchor stent in the first anchoring state, the transcatheter biological annular valve is approached through a catheter and released by balloon inflation, and is integrally coupled with the transcatheter annular valve anchor stent, and the transcatheter annular valve anchor stent expands from its original conical funnel shape to a cylindrical shape together with the transcatheterized annular valve, and clamps and tightly couples with the transcatheterized annular valve by recovering its shape to its axis through secondary deformation, while completing the tight pre-set anchoring with the patient's mitral valve position or tricuspid valve position and subvalvular tissue.

7. The separate, precisely anchorable transcatheter annular valve system of claim 6.

9. The three-dimensionally reconstructed true structure is a digital image model or a 3D printing simulation solid model, and the three-dimensionally reconstructed true structure is a virtual simulation three-dimensional dynamic image after digitally converting the integrated image of CT, ultrasound and nuclear magnetism and a corresponding 3D printing simulation solid model; 4. The separate, precisely anchorable transcatheter annular valve system of claim 1.

10. The anchor stent of the mid-annular valve has an umbrella-type stent structure, and includes an atrial surface, a ventricular surface, and a connecting portion of the anchor stent between them, the atrial surface being umbrella-like, i.e., a first lattice portion, which matches a true shape three-dimensionally reconstructed based on image data of the atrial surface of the patient, the ventricular surface including two positioning hook loops accurately preset at the boundary positions of the valve leaflets, and the connecting portion of the anchor stent being round-mouthed funnel-shaped and including a second lattice portion.

7. The separate, precisely anchorable transcatheter annular valve system of claim 6.

11. The first anchor state of the connection part of the anchor stent of the annular valve is a first state after being delivered and released through a catheter, which is a fixed shape memory state of the stent outside the body, and the fixed shape memory state of the connection part from the atrial surface to the ventricular surface has a contraction gradient, the gradient is 5 to 45 degrees, and the connection part of the anchor stent is deformed from the first anchor state to a cylindrical second anchor state by deformation and expansion.

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

12. The positioning hook loops are two, which allows accurate registration and matching with the boundary positions of two leaflets of the patient's mitral valve (mitral annuloplasty ring), or three, which allows accurate registration and matching with the boundary positions of three leaflets of the patient's tricuspid valve (tricuspid annuloplasty ring).

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

13. In the first anchoring state of the transcatheter annular valve anchor stent, the positioning hook loop is released from the atrial surface of the annular valve anchor stent through a catheter and inserted into the corresponding leaflet boundary position of the patient's mitral valve or tricuspid valve, so that the atrial surface of the positioning anchor stent matches the shape of the patient's atrium; in the second anchoring state after deformation of the transcatheter annular valve anchor stent, the outer periphery of the connection part between the positioning hook loop and the anchor stent is filled between the inside of the annulus plasty ring and the connection part of the transcatheter annular valve.

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

14. In the second anchoring state, the positioning hook loop is filled into the eccentric region of the previously implanted annuloplasty ring, so that the central axis of the connection portion of the anchor stent of the annulus valve is coaxial with the center of the previously implanted annuloplasty ring.

14. The separate, precisely anchorable transcatheter annular valve system of claim 13.

15. The ventricular surface of the annular valve anchor stent has a plurality of anchor hook loops, which extend from the connection portion to the ventricular surface and then turn back, and match the shape of the true subvalvular tissue reconstructed three-dimensionally based on the subvalvular image data of the patient's dysfunctional valve leaflet.

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

16. In a first anchoring state of the intra-annular valve anchor stent, the anchor hook loops are aligned with the subvalvular tissue of the patient's dysfunctional valvuloplasty ring after being released through a catheter; in a second anchoring state of the intra-annular valve anchor stent, the plurality of anchor hook loops are deformed to form a clamping portion due to the action of a resultant force between the atrial surface of the intra-annular valve anchor stent and the connecting portion, and the plurality of deformed anchor hook loops are tightly coupled to the leaflets and subvalvular tissue of the patient's dysfunctional valvuloplasty ring by entanglement.

16. The separate, precisely anchorable transcatheter annular valve system of claim 15.

17. The anchor hook loops are 2 to 9.

17. The separate, precisely anchorable transcatheter annular valve system of claim 16.

18. At the end of the atrial surface of the connecting portion of the anchor stent of the annular valve, a plurality of fixed support rods or stent bends for inserting the transcatheter annular valve stent are provided, and the fixed support rods or stent bends extend axially along the atrial surface, and their ends are bent toward the axis of the anchor stent.

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

19. The connecting portion of the anchor stent of the annular valve is provided with a plurality of terminal centripetal hooks for inserting the outflow end of the transcatheter annular valve stent, and the ends of the atrial surface of these centripetal hooks and the connecting portion of the anchor stent of the annular valve are provided with a plurality of fixed support rods or bends for inserting the atrial end of the transcatheter annular valve stent, surrounding them from above and below, forming a fit with the anchor stent and integrating them, so that zero displacement is achieved when the transcatheter prosthetic biological annular valve is released.

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

20. The fixed support rod or stent bends are 3 to 12.

20. The separate, precisely anchorable transcatheter annular valve system of claim 19.

21. The first lattice portion and the second lattice portion of the anchor bolt of the annular valve are formed by a unit lattice consisting of a compressible rhombic lattice, a V lattice, and / or a hexagonal or polygonal lattice, and the first lattice portion and the second lattice portion are adaptively connected; 11. The separate, precisely anchorable transcatheter annular valve system of claim 10.

22. a distance between the outer periphery of the first lattice portion and the patient's atrial wall of 1 to 2 mm; 11. The separate, precisely anchorable transcatheter annular valve system of claim 10.

23. The diameter of the inner periphery of the second lattice portion matches the outer diameter of various corresponding sizes of transcatheter prosthetic annular valves.

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

24. The surface of the annular valve anchor stent is coated with a thin film of medical polymer; 4. The separate, precisely anchorable transcatheter annular valve system of claim 1.

25. The atrial surface, the ventricular surface, and the connection portion of the anchor stent of the annular valve are a three-dimensional shaped structure after laser integral cutting or a separate joint structure; 4. The separate, precisely anchorable transcatheter annular valve system of claim 1.

26. The anchor stent is a metal material or a non-metal material having shape memory properties that allow it to recover its shape, and the anchor stent is made of a nickel-titanium alloy material.

4. The separate, precisely anchorable transcatheter annular valve system of claim 1.

27. The transcatheter prosthetic biological annular valve includes a cobalt-chromium alloy stent that assumes a cylindrical shape after being radially compressed and expanded by a balloon, or a nickel-titanium alloy stent that assumes a cylindrical shape after being radially compressed and self-expanded, and three fan-shaped valve leaflets disposed inside the stent, each of which has a free edge, an arc-shaped base, and leaflet boundary connections extending on both sides, and the stent is a metal net tube.

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

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

23. The separate, precisely anchorable transcatheter annular valve system of claim 22.

29. The transcatheter annular valve anchor stent delivery device and the prosthetic biological annular valve delivery device are delivered to the tricuspid annular valve via an approach from the inferior vena cava via the femoral vein or from the superior vena cava via the jugular vein or subclavian vein to the tricuspid valve position, and to the mitral annular valve via an apical approach, a left atrial approach, or a femoral vein-atrial septal approach to the mitral valve position.

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

30. Each time a treatment procedure for a transcatheter annular valve prosthesis that achieves accurate molding and anchoring based on a single personalized pre-setting is completed, all parameter data of the personalized transcatheter annular valve system are stored as an independent data unit, and a large amount of personalized data is accumulated. By using big data algorithms and AI, the intelligent, large-scale, and industrialized transcatheter annular valve system that can achieve accurate anchoring of the separate type is realized.

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

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