Separate, precisely anchored transcatheter aortic valve system

Abstract

A separate, precisely anchored transcatheter aortic valve system includes a separate transcatheter aortic valve anchor stent (10) and a transcatheter bioprosthetic aortic valve (20), the shape and structure of the transcatheter aortic valve anchor stent (10) matching the true structure of the aortic valve after three-dimensional reconstruction based on a patient's image data, and the transcatheter aortic valve anchor stent (10) being delivered to a patient's aortic valve position, deforming, and aligning with the patient's aortic valve leaflet tissue and subvalvular tissue. The transcatheter bioprosthetic aortic valve (20) is delivered within the transcatheter aortic valve anchor stent (10) and released, the leaflet stent expanding to expand the leaflet into a functional state, re-deforming the transcatheter aortic valve anchor stent (10) to engage and bond with the expanded transcatheter bioprosthetic aortic valve (20), and simultaneously re-deforming and anchoring the transcatheter aortic valve anchor stent (10). The system designed based on the three-dimensional reconstruction can achieve personalized and precise anchoring of the transcatheter aortic valve.

Description

[Technical field]

[0001] This application relates to prosthetic biological heart valves, and more particularly to a transcatheter aortic valve system that allows for separate, precise anchoring. [Background technology]

[0002] The research, development and clinical application of transcatheter aortic valve (TARV) has been going on for 20 years. With the advantages of minimally invasiveness, no need for extracorporeal circulation, and appropriate short-term and mid-term effects, it has already been recognized as an effective treatment for elderly or high-risk patients with traditional surgical aortic valve replacement. Currently, transcatheter aortic valve (TAVR) surgery has been performed in 1,400 hospitals in 65 countries around the world, with a total of more than 600,000 transcatheter aortic valves of various types implanted (Figure 1), which is increasing by 40% every year, and the number of TAVR surgeries worldwide in 2021 reached 182,000. However, for some patients with severely calcified bileaflet aortic valve, ascending aortic dilation, coronary artery obstruction risk, and simple aortic regurgitation (AR), traditional TAVR products cannot meet the emergency needs of such patients, and for patients with severe aortic stenosis, various serious complications are always involved, such as valve regurgitation, valve displacement, and even detachment due to deformation after release of the valve leaflet, coronary artery opening infarction, severe perivalvular leakage, re-implantation of a regenerative pacemaker due to compression and damage to the sinoatrial node, and rupture of the valve annulus and even death due to excessive expansion of the valve leaflet. The existence of these complications not only puts various types of complicated patients at risk, but also increases the difficulty of the surgeon's skill acquisition and the challenge of accumulating experience over a long period of time. It is expected that these problems can be successfully solved if a precise and stable anchoring effect can be ensured after the transcatheter aortic valve is released. Summary of the Invention

[0003] In view of the above, the transcatheter aortic valve system of the present application provides a separate design based on the true pathological anatomical structure of the aortic valve after it is three-dimensionally reconstructed based on the patient's individual image data, and includes two parts: a transcatheter aortic valve anchor stent and a transcatheter bioprosthetic aortic valve. First, a specific stent is transcatheterized to clamp with the valve leaflet, and then the transcatheter bioprosthetic aortic valve is approached and released into the stent, thereby integrating the transcatheter bioprosthetic aortic valve and the anchor stent, thereby realizing a precise and predetermined anchor.

[0004] The present application relates to a separate transcatheter aortic valve system capable of precise anchoring, including a separate transcatheter aortic valve anchor stent, a transcatheter bioprosthetic aortic valve prosthesis via a catheter, and a corresponding delivery system and kit. The shape and structure design of the transcatheter aortic valve anchor stent is matched to the true structure of the lesion aortic valve after three-dimensional reconstruction based on the patient's image data, and the transcatheter aortic valve anchor stent is delivered to the patient's aortic valve position via a catheter, and the anchor wire loop, the connection structure of the stent and the lattice of the inflow surface of the aortic valve anchor stent are sequentially released, and each part of the aortic valve anchor stent and the outflow surface and inflow surface of the patient's aortic valve are sandwiched with the leaflet pocket tissue above and below, maintaining the original function of the lesion aortic valve, and a channel is opened for the next approach into the transcatheter bioprosthetic aortic valve anchor stent via a catheter, i.e., the aortic valve anchor stent is in the first state. The transcatheter bioprosthetic aortic valve is compressed, loaded and transported into the previously transcatheterized first state aortic valve anchor stent through a transport device catheter, and as the transcatheter bioprosthetic aortic valve expands due to balloon-assisted expansion of the bioprosthetic aortic valve (or the self-expansion of the nickel-titanium memory alloy stent), the aortic valve anchor stent is transformed into a cylindrical second anchor state and engages with the transcatheter bioprosthetic aortic valve to achieve an integrated bond; at the same time, the anchor wire loops or lattices on both ends of the anchor stent in the second state are tightly coupled with the aortic valve leaflets and subvalvular tissue to achieve transcatheter treatment of all indications of aortic valve lesions (stenosis or regurgitation and stenosis combined with regurgitation) of the patient's lesions.

[0005] The technical proposal and implementation process of this application are as follows:

[0006] The transcatheter aortic valve system capable of separate accurate anchoring includes a separate transcatheter aortic valve anchor stent and a transcatheter bioprosthetic aortic valve. (1) The shape and structure of the transcatheter aortic valve anchor stent is designed by reconstructing the true anatomical structure and shape of the three-dimensional aortic valve based on CT and ultrasound image data of the aortic valve position of a patient by approaching a dedicated software, creating a first state of the transcatheter aortic valve anchor stent through laser cutting, three-dimensional molding, heat treatment processing and polishing, and preparing by cleaning, packaging and disinfection. (2) The anchor stent is loaded into a transport device by a loader, transported to the aortic valve position of the patient by the transport device, positioned and released, and the deformation of the stent assumes a first anchor state and aligns with the aortic valve leaflets and subvalvular tissue of the patient. (3) After the transcatheter bioprosthetic aortic valve is loaded into a transportation device, it is transported into and released into the anchor stent of the transcatheter aortic valve, and the external force of the balloon expansion deploys the transcatheter bioprosthetic aortic valve into a functional state, while the anchor stent of the aortic valve is deformed again accordingly to fit and connect with the expanded transcatheter bioprosthetic aortic valve, and the anchor stent of the aortic valve is deformed again into a second anchor state, and the final predetermined anchoring is achieved by the connection of the valve leaflet tissue.

[0007] Further, the separate, precisely anchorable transcatheter aortic valve system includes a delivery assembly including a transcatheter bioprosthetic aortic valve anchor stent delivery kit and a transcatheter bioprosthetic aortic valve delivery kit, the transcatheter bioprosthetic aortic valve anchor stent delivery kit including a delivery catheter, and a transcatheter bioprosthetic aortic valve anchor stent loader.

[0008] The aortic valve anchor stent has a compressed state disposed in a catheter, a first anchor state after being released through the catheter, and a second anchor state after being coupled to a transcatheter bioprosthetic aortic valve, in which in the first anchor state, the aortic valve anchor stent is aligned and joined to the aortic valve leaflets and the corresponding subvalvular tissue of the inflow surface of the patient after being released through the delivery device, and in the second anchor state, the aortic valve anchor stent is expanded and secondary deformed to couple with the transcatheter bioprosthetic aortic valve, while completing the final anchor coupling with the tissue at the aortic valve position of the patient. The three-dimensionally reconstructed true structure is a digital image model or a 3D printing simulation real model. The three-dimensionally reconstructed anatomical structure simulating the aortic valve lesion based on the patient's image data is a simulation three-dimensional image model and a corresponding 3D printing simulation real model after digital conversion of the patient's CT, ultrasound and nuclear magnetic comprehensive images. The aortic valve anchor stent has an umbrella stent structure, including an outflow surface of a leaflet, an inflow surface of a leaflet, and a connection between the two, the outflow surface of the leaflet is two or three anchor wire loops, which match the true shape reconstructed three-dimensionally based on the image data of the outflow surface of the patient's leaflet, the inflow surface of the leaflet of the anchor stent is an anchor wire loop corresponding to the wire loop of the outflow surface, and can form a structure to clamp the leaflet together with the anchor wire loop of the outflow surface, the shape of which matches the true shape reconstructed three-dimensionally based on the subvalvular image data of the aortic valve, and the connection part of the anchor stent is a round-mouthed funnel-shaped lattice, and the inner diameter of the formed circumference matches the outer diameter of the transcatheter bioprosthetic aortic valve stent after release.The outflow surface of the leaflet is a distal outflow end, the inflow surface of the leaflet is a proximal inflow end, the anchor wire loop at the outflow end is a near-circular fold formed by extending a lattice of a connection part of a stent, the shape, size and fold angle of the anchor wire loop at the outflow end match the shape of a simulation of a lesion reconstructed three-dimensionally based on image data of a patient, the anchor wire loop at the inflow end of the stent is a relatively small near-circular fold or a single row of diamond lattice structure, the shape, size and fold angle of the near-circular fold at the inflow end Or a row of diamond lattice structures matches the shape and circumference of a simulation of the base of the leaflets at the inflow end of the aortic valve reconstructed three-dimensionally based on the patient's image data, and the connection part of the stent is a conical funnel-shaped lattice or three support bars connecting the inflow end and outflow end, the slope of the former matching the shape of a simulation of the aortic valve reconstructed three-dimensionally based on the patient's image data, and the length measurement is the true length from the lower edge of the coronary artery opening in the patient's image to the bottom of the leaflets at the inflow end of the aortic valve. In the first anchoring state, the transcatheter aortic valve anchor stent is released through the catheter and then returned from the compressed state, the anchor wire loop at the outflow end of the stent is folded back and extends into the valve pocket of the aortic valve leaflet of the patient's lesion, the relatively small anchor wire loop of a near-circular shape corresponding to the inflow end of the stent is folded back to the base of the leaflet at the inflow end of the aortic valve of the lesion, the wire loops corresponding to both ends form an aligned clamp inside, outside, above and below the leaflet, and the lattice of the connection part of the aortic valve anchor stent is released and recovers its shape, forming a funnel shape at the intersection position of the aortic valve leaflet of the lesion, bringing the leaflet into an approximately normal opening and closing state.In the second anchoring state, in the first anchoring state, the transcatheter bioprosthetic aortic valve grasped in a strip shape enters the stent via the catheter and is expanded and released by the balloon, and the external force caused by the expansion of the balloon causes the transcatheter bioprosthetic aortic valve to expand from a strip shape to a cylindrical shape (functional state), and at the same time, the anchor stent is secondary deformed from a funnel shape to a cylindrical shape and tightly combines with the transcatheter bioprosthetic aortic valve, and then the secondary deformation of the anchor stent of the transcatheter aortic valve is again finally anchored with the aortic valve leaflets of the patient's lesion and the root tissue of the leaflets attached to the aortic wall.

[0009] The outflow and inflow surfaces of the connection part of the aortic valve anchor stent are both provided with fixed support rods or stent terminal bends for inserting a transcatheter bioprosthetic aortic valve stent, the direction of the fixed support rods or stent terminal bends is bent along the axis, and when the direction of the fixed support rods or stent terminal bends is bent and deformed along the axis to form a cylindrical shape in the second state, the distance between the fixed support rods or stent terminal bends at both ends of the outflow and inflow surfaces of the connection part of the aortic valve anchor stent matches the height of the transcatheter bioprosthetic aortic valve stent. A plurality of terminal centripetal hooks are provided at both ends of the connection part of the aortic valve anchor stent for inserting the outflow end of the transcatheter bioprosthetic aortic valve stent, and these centripetal hooks and the inflow end of the connection part of the aortic valve anchor stent are provided with a plurality of fixed support rods or stent bends for inserting the inflow end of the transcatheter bioprosthetic aortic valve stent, surrounding them from above and below, thereby preventing the occurrence of displacement during release of the transcatheter bioprosthetic aortic valve. The number of the fixed support rods or stent bends is 3-12, preferably 3-6. The lattice of the connection part of the aortic valve anchor stent is a unit lattice consisting of compressible diamond lattice, V-shaped lattice, and / or hexagonal or polygonal lattice, and the lattice part is adaptively connected to the anchor wire loops at both ends. The outer periphery of the arc of the anchor wire loop at the inflow end of the aortic valve anchor stent is tightly coupled to the lower base of the aortic valve of the patient. In the second state, the connection part of the aortic valve anchor stent has a cylindrical inner diameter that matches the outer diameter of various corresponding sizes of transcatheter bioprosthetic aortic valves. The surface of the aortic valve anchor stent is coated with a single layer of medical polymer thin film. The aortic valve anchor stent is a three-dimensional molded structure after laser integral cutting or a separate connection structure. The anchor stent is made of a nickel-titanium alloy material.

[0010] The transcatheter bioprosthetic aortic valve of the present application includes a cobalt-chromium alloy stent that is radially compressed and then expanded by a balloon to assume a cylindrical shape, or a nickel-titanium alloy stent that is radially compressed and then self-expanded to assume a cylindrical shape, and three sector-shaped leaflets disposed inside the stent, each of the three sector-shaped leaflets has a free edge, an arc-shaped base and a leaflet boundary connection extending to both sides, and the stent is a metal net tube. The stent of the valve is a cobalt-based alloy, cobalt or chromium alloy, or nickel-titanium alloy. The transcatheter aortic valve anchor stent is first transcatheterized to the aortic valve position of the lesion through the transcatheter aortic valve anchor stent delivery catheter and released to a first anchor state, then the transcatheter bioprosthetic aortic valve is again delivered to the anchor stent through the transcatheter bioprosthetic aortic valve delivery device catheter, and the transcatheter bioprosthetic aortic valve expands to a second anchor state while the transcatheter bioprosthetic aortic valve expands, and finally the stent joint is engaged with the transcatheter bioprosthetic aortic valve and the stent is deformed to the second state at the same time, completing further tight coupling with the valve circumference and subvalve tissue to form a final anchor. The transcatheter bioprosthetic aortic valve delivery kit includes a transcatheter bioprosthetic aortic valve delivery device, a guide sheath, a transcatheter bioprosthetic aortic valve gripper, and a charge pump.

[0011] The system of the present application is approached via the femoral artery, carotid artery, subclavian artery or apical approach route, and the transcatheter aortic valve anchor stent and the transcatheter bioprosthetic aortic valve are approached back and forth via the same route or back and forth via separate routes. Every time a treatment process of a transcatheter bioprosthetic aortic valve that realizes accurate anchoring for a specific patient's individual preset is completed, all the above related data are stored as independent data units, and a large amount of personalized data is accumulated, and the separate, accurate anchoring capable transcatheter aortic valve system is intelligentized, large-scaled and industrialized through artificial intelligence. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a diagram of various integrated aortic valves in the prior art. [Diagram 2] 2A-C are schematic diagrams of anchor stents of different configurations according to embodiments of the present application. [Diagram 3] 3A-B are schematic diagrams of the outflow and inflow surfaces of an anchor stent according to an embodiment of the present application. [Figure 4] 4A-C are diagrams illustrating the coupling of an anchor stent to an aortic valve according to an embodiment of the present application. [Diagram 5] 5A-B are schematic diagrams of the outflow and inflow surfaces after an anchor stent according to an embodiment of the present application is coupled to an aortic valve. [Figure 6] 6A-B are schematic diagrams of a first anchoring state of an anchor stent of a transcatheter aortic valve according to an embodiment of the present application after it has been released through a catheter. [Figure 7] 7A-B show a second anchored state after a transcatheter aortic valve according to an embodiment of the present application has been delivered to an anchor stent via a catheter. [Figure 8] FIG. 8 is a schematic diagram of a transcatheter aortic valve according to an embodiment of the present application. [Figure 9] FIG. 9 is a schematic diagram of a transcatheter prosthetic aortic valve delivery system according to an embodiment of the present application. [Figure 10] FIG. 10 is a schematic diagram of the loading of a transcatheter aortic valve anchor stent according to an embodiment of the present application. [Figure 11] 11A-C are schematic diagrams of rotational loading of a transcatheter aortic valve anchor stent via a femoral artery access according to an embodiment of the present application. [Figure 12] 12A-C are schematic diagrams of an aortic valve via a femoral artery access entering the anchor stent shown in FIG. 11 according to an embodiment of the present application. [Figure 13]13A-C are schematic illustrations of rotational loading of a transcatheter aortic valve anchor stent via an apical approach according to an embodiment of the present application. [Figure 14] 14A-C are schematic diagrams of a transcatheter aortic valve entering the anchor stent shown in FIG. 13 via an apical approach according to an embodiment of the present application. [Figure 15] 15A-D are schematic diagrams of anchor stents for bileaflet valve patients according to embodiments of the present application. [Figure 16] 16A-C are schematic diagrams of anchor stents for patients with different lesions according to embodiments of the present application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The separate, precisely anchored transcatheter aortic valve system in this embodiment includes a separate transcatheter aortic valve anchor stent 10 and a transcatheter bioprosthetic aortic valve 20, the shape and structure of the transcatheter aortic valve anchor stent is matched to the true structure of the aortic valve after three-dimensional reconstruction based on the patient's individual image data, the transcatheter aortic valve anchor stent is released and deformed at the aortic valve position of the patient, and aligns and couples with the aortic valve leaflets and subvalvular tissue of the patient. The transcatheter bioprosthetic aortic valve is delivered and released into the transcatheter aortic valve anchor stent, the transcatheter bioprosthetic aortic valve is deformed and expanded to expand the transcatheter bioprosthetic aortic valve into a functional state, and the aortic valve anchor stent is deformed again to engage with the expanded transcatheter bioprosthetic aortic valve, and the aortic valve anchor stent is deformed again to anchor.

[0014] 2 to 5, the transcatheter aortic valve anchor stent of this embodiment is one of the important components of the separate type transcatheter aortic valve system capable of accurate anchoring of the present application. Its material is nickel titanium alloy, and the aortic valve anchor stent has an umbrella-type stent structure, and is composed of three parts: (1) anchor wire loop 11 on the outflow surface of the stent, (2) anchor wire loop 12 or anchor lattice 14 on the inflow surface of the stent, and (3) stent connection part 13. The outflow surface of the leaflet is two or three outflow surface anchor wire loops, which match the true shape reconstructed three-dimensionally based on the image data of the outflow surface of the leaflet of the patient, and the inflow surface of the leaflet of the anchor stent corresponds to the outflow surface anchor wire loop, and can form a structure that sandwiches the outflow surface anchor wire loop and the leaflet 30, and the shape matches the true shape reconstructed three-dimensionally based on the subvalvular image data of the aortic valve. The connection part of the anchor stent is a round-mouthed funnel-shaped lattice, and the inner diameter of the formed circumference matches the outer diameter of the transcatheter aortic valve anchor stent after release. The lattice of the connection part of the aortic valve anchor stent is a unit lattice consisting of compressible rhombic lattice, V-shaped lattice, and / or hexagonal or polygonal lattice, and the lattice part is adaptively connected to the anchor wire loops at both ends. The anchor wire loop on the outflow surface matches the true shape reconstructed three-dimensionally based on the image data of the outflow surface of the patient's valve leaflet and the true shape reconstructed three-dimensionally based on the image data under the aortic valve, so that based on the same design principles and concepts as above, the specific shape and structure of the anchor wire loop are also slightly different, as shown in the drawings, to realize more accurate personalized design and adaptation and achieve better post-operative effects.

[0015] A fixed support rod 111 or a stent end bend 112 of the transcatheter bioprosthetic aortic valve anchor stent is provided on both the outflow surface and the inflow surface of the connection part of the aortic valve anchor stent (see FIG. 4C , which is a partially enlarged schematic diagram showing the type of the fixed support rod), and the direction of the fixed support rod or the stent end bend is bent along the axis, and when the direction of the fixed support rod or the stent end bend is bent and deformed along the axis, and the second state is cylindrical, the distance between the fixed support rods or the stent end bends at both ends of the outflow surface and the inflow surface of the connection part of the aortic valve anchor stent matches the height of the transcatheter bioprosthetic aortic valve anchor stent. At both ends of the connection part of the aortic valve anchor stent, a plurality of terminal centripetal hooks for inserting the outflow end of the anchor stent of the transcatheter bioprosthetic aortic valve are provided, and at the inflow end of the connection part of the aortic valve anchor stent and the inflow end of the connection part of the aortic valve anchor stent, a plurality of fixed support rods or stent bends for inserting the inflow end of the anchor stent of the transcatheter bioprosthetic aortic valve are provided to surround the upper and lower parts, thereby preventing the occurrence of displacement during the release of the aortic valve. The number of the fixed support rods or stent bends is 3 to 12, preferably 3 to 6. The outer periphery of the arc of the anchor wire loop at the inflow end of the aortic valve anchor stent is 1 to 2 mm, preferably 1.5 mm, away from the aortic wall at the bottom of the aortic valve of the patient. In the second state, the connection part of the aortic valve anchor stent has a cylindrical inner diameter that matches the outer diameter of various corresponding size standards of the transcatheter bioprosthetic aortic valve. The surface of the aortic valve anchor stent is coated with a single layer of a medical polymer thin film.

[0016] The transcatheter bioprosthetic aortic valve includes a cobalt-chromium alloy stent that is radially compressed and then expanded by a balloon to assume a cylindrical shape, or a nickel-titanium alloy stent that is radially compressed and then self-expanded to assume a cylindrical shape, and three sector-shaped leaflets disposed inside the stent, each of the three sector-shaped leaflets has a free edge, an arc-shaped base and leaflet boundary connections extending on both sides, and the stent is a metal net tube, which is similar to the structure known in the art.

[0017] The number, shape, size and radian of the anchor wires on the outflow and inflow surfaces of the transcatheter aortic valve anchor stent are matched to the preoperative CT image data of the aortic valve of the patient's lesion, the true structure after three-dimensional reconstruction (3mensio) and the true scale in each direction obtained by measuring the image, thereby creating the processing drawing of the transcatheter aortic valve anchor stent, and finally manufacturing the individual transcatheter aortic valve anchor stent through three-dimensional laser cutting and three-dimensional molding of the specific nickel-titanium memory alloy tube material. The normal aortic valve has a trileaflet structure, but there are also patients with bicuspid leaflet malformation due to congenital defects, and there are also calcification of the valve leaflet and wind-wet aortic valve lesions due to senile involution. The morphology of each type of aortic valve lesion is matched to the true structure of the aortic valve after three-dimensional reconstruction based on the image data.

[0018] The pre-compression state of the aortic valve anchor stent manufactured as a stent by the above-mentioned real data processing of the patient's image is also the first anchor state after the stent is transported to the position of the diseased valve in the aortic valve through the transport device catheter (see FIG. 6). The second anchor state of the transcatheter aortic valve anchor stent is that the transcatheter bioprosthetic aortic valve is transported into the anchor stent through the transport device catheter, expanded by the balloon, the transcatheter bioprosthetic aortic valve is expanded (or the nickel-titanium memory alloy aortic valve stent is self-expanded), the transcatheter bioprosthetic aortic valve anchor stent is transformed from the first anchor state to the second anchor state, and the deformation force of the stent is combined with the balloon expansion force released by the transcatheter bioprosthetic aortic valve to be integrated (see FIG. 7), and at the same time, in the second state of the transcatheter aortic stent, it is tightly combined with the valve circumference and subvalve tissue 40 to achieve the final anchoring (FIG. 7B). At the same time, in the first anchor state of the anchor stent, as the fixed support rod on the atrial side of its connecting structure transforms into the second anchor state, the fixed support rods on both ends of the stent or the stent bends surround the axis and become parallel to the axial direction, and the fixed support rods or the stent bend ends are engaged with the support rods on both ends of the anchor stent of the transcatheter bioprosthetic aortic valve by the resultant force, and such anchor stent automatically anastomoses with both ends of the transcatheter bioprosthetic aortic valve, and the transcatheter bioprosthetic aortic valve and the anchor stent are accurately combined and integrated, ensuring zero displacement of the transcatheter bioprosthetic aortic valve (see Figure 4).

[0019] The contents of this application can be summarized as follows: (1) The separate transcatheter aortic valve system is composed of two parts, a transcatheter aortic valve anchor stent and a transcatheter aortic valve, a delivery system, and a system kit. (2) The anchor stent is designed based on the image data of the aortic valve lesion of the patient before surgery, converted into a three-dimensional real structure, and a relatively large, quasi-circular anchor wire loop on the outflow surface of the anchor stent and a relatively small, circular anchor wire loop on the inflow surface are designed, and the connection structure of the stent between both ends is a cone-shaped funnel-shaped lattice stent structure. (3) The anchor wire loop designed using the aortic valve leaflet structure of the lesion accurately positions and anchors the wire loops on the outflow surface and inflow surface of the stent. (4) The anchor stent can be released at the aortic valve position through the femoral artery or the apex of the heart to a first anchor state, and then the anchor stent is transformed into a second anchor state in the diseased aortic valve by the deformation force released by the expansion of the balloon of the transcatheter bioprosthetic aortic valve, so that the transcatheter bioprosthetic aortic valve and the anchor stent can automatically fit and integrate in the heart in the second anchor state, while simultaneously clamping the perivalve and subvalve tissues to finally anchor. (5) The anchor stent transforms from the first state to the second state, and this transformation process realizes automatic coupling with the transcatheter bioprosthetic aortic valve, and can reach automatic accuracy in the release operation of the transcatheter bioprosthetic aortic valve. Transcatheter bioprosthetic aortic valve and delivery system and implementation

[0020] 9-10, the delivery system of the present embodiment includes a delivery catheter, a transcatheter aortic valve anchor stent loader and a transcatheter bioprosthetic aortic valve gripper, a valve ejection balloon, and a delivery device kit.

[0021] 11-12, in embodiment 1, first, the loaded anchor stent is delivered into the aortic valve of the patient's lesion through the femoral artery (FIG. 11A), and the inflow and outflow surfaces of the anchor stent are sequentially released (FIG. 11B), that is, the anchor stent is in the first state (FIG. 11C). Referring to FIG. 12A-C, after the release of the anchor stent is completed, the conduit is withdrawn, and the pre-loaded transcatheter bioprosthetic aortic valve is delivered into the anchor stent through the catheter (FIG. 12A), and then the anchor stent is transformed into the second anchor state by the balloon-assisted expansion of the transcatheter bioprosthetic aortic valve (FIG. 12B), which realizes self-precise coupling with the transcatheter bioprosthetic aortic valve, and is clamped with the subvalve tissue to complete the final anchor (FIG. 12C).

[0022] 13-14, in embodiment 2, the loaded anchor stent is delivered into the aortic valve of the patient's lesion by apical puncture (FIG. 13A), and the outflow surface (FIG. 13B) and the inflow surface of the anchor stent are sequentially released, that is, the anchor stent is in the first state (FIG. 13C). After the release of the anchor stent is completed, the transcatheter bioprosthetic aortic valve is held in the transport sheath in advance, and the transcatheter bioprosthetic aortic valve is delivered into the anchor stent by apical puncture (FIG. 14A). Then, the transcatheter bioprosthetic aortic valve is expanded by balloon assistance to transform the anchor stent into the second anchor state (FIG. 14B), which realizes self-precise coupling with the transcatheter bioprosthetic aortic valve, and is tightened with the perivalve and subvalve tissues to complete the final anchor (FIG. 14C).

[0023] Also, in the case of an anchor stent for a transcatheter aortic valve in a bileaflet valve patient, it is similar to the anchor stent for a trileaflet valve patient, and referring to FIG. 15, the number of anchor wire loops in this embodiment is two.

[0024] In some cases, the location of the aortic valve is very limited and accordingly the lattice of the anchor stent connection structure is designed to be shorter to improve compatibility with the surrounding tissue.

[0025] The above embodiments are merely for fully illustrating the embodiments of the specifications set forth by the present application. The transcatheter aortic valve system of the present application has already implemented the above-mentioned technical proposal through industrial animal testing.

[0026] The feasible significance of this application is as follows: (1) The separate design functionally separates the anchor of the transcatheter bioprosthetic aortic valve and the support of the stent of the transcatheter bioprosthetic aortic valve on the valve leaflets, and passes the anchor that transcatheters the bioprosthetic aortic valve to the aortic valve position to the anchor stent, thereby realizing a more accurate anchor through the true anatomical form reconstructed three-dimensionally based on the specific image data of the patient and the personalized design of the anchor stent structure, and by performing the transcatheterization of the anchor stent and the transcatheterization of the bioprosthetic aortic valve in stages, it is possible to avoid the difficulty of clamping due to the complex structure and excessive volume, which makes it difficult to transport via a catheter. (2) Through the pre-design and measurement of the anchor principle and the final anchor site for the anatomical structure characteristics of the diseased valve, the second anchor state of the anchor stent can be preset, and the patient's individualized radiological data, dedicated software and 3D printing complete the design and processing of the three-dimensional shape of the first anchor state, in which the dimensions and dimensions of each site of the anchor stent are preset, that is, the three-dimensional shape of the first anchor state is accurately aligned after being released through the catheter, which can support the smooth transcatheter transport of the prosthetic bioprosthetic aortic valve. The gradient structure of the first state of the anchor stent can open severe stenosis moderately and widely, and can also suppress severe regurgitation. The former can not only provide a channel for the transcatheter of the prosthetic bioprosthetic aortic valve, but also avoid the sudden expansion of the stenotic lesion, and the latter can alleviate the large amount of reflux of the transcatheter prosthetic bioprosthetic aortic regurgitation and ensure the provision of space and time for the transcatheter to the transcatheter prosthetic bioprosthetic aortic valve. (3) The external force released from the transcatheter bioprosthetic aortic valve drives the anchor stent to deform from the first anchor state to the second state, and such deformation allows the anchor stent to be integrally coupled with the transcatheter bioprosthetic aortic valve toward the axis, ensuring the zero displacement of the transcatheter bioprosthetic aortic valve, and further tightly coupled with the subvalvular tissue through the anchor lattice or hook-and-loop structure on the inflow surface, realizing the pre-designed aligned anchor, and completing the clamping with the supravalvular structure to finally complete the pre-set anchor.(4) The support rod structure provided at the inflow and outflow ends of the connection part of the transcatheter aortic valve anchor stent is integrated with the aortic valve by embracing both ends, ensuring that the transcatheter prosthetic aortic valve does not shift. (5) The above-mentioned separate-type transcatheter aortic valve system capable of precise anchoring accumulates a large amount of unique image data, design and processing parameters of the anchor stent, transcatheter treatment process, postoperative progress data, etc., obtained through the analysis of related data, the shape design, processing and manufacturing of the transcatheter aortic valve anchor stent, and the entire process of transcatheter treatment, as an independent data unit, each time a treatment process of accurately transcatheterizing a specific individual aortic valve is completed, and realizes smart, commercial and large-scale implementation of the separate-type transcatheter aortic valve system capable of precise anchoring in treatment.

Claims

1. A separate transcatheter bioprosthetic aortic valve anchoring stent and a transcatheter bioprosthetic aortic valve system capable of separate precise anchoring, comprising: The transcatheter bioprosthetic aortic valve includes a stent and three leaflets; The shape and structure of the transcatheter bioprosthetic aortic valve anchor stent is matched to a true structure of the aortic valve after three-dimensional reconstruction based on the patient's image data, and the transcatheter bioprosthetic aortic valve anchor stent is delivered to the patient's aortic valve position for release, deformation, and alignment with the leaflet tissue and subvalvular tissue of the aortic valve of the patient; The transcatheter bioprosthetic aortic valve is delivered into and released from an anchor stent of the transcatheter bioprosthetic aortic valve, the stent deforms to expand the transcatheter bioprosthetic aortic valve to a functional state, and the anchor stent of the transcatheter bioprosthetic aortic valve is deformed again to engage with the expanded transcatheter bioprosthetic aortic valve, and at the same time, the anchor stent of the transcatheter bioprosthetic aortic valve is deformed again to anchor; The anchor stent of the transcatheter bioprosthetic aortic valve has a compressed state disposed in a delivery catheter, a first anchor state after being released through the catheter, and a second anchor state after being coupled to the transcatheter bioprosthetic aortic valve, in which in the first anchor state, the anchor stent of the transcatheter bioprosthetic aortic valve is deformed after being released to align and join with the leaflets of the aortic valve and the subvalvular tissue of the corresponding inflow surface of the patient, and in the second anchor state, the anchor stent of the transcatheter bioprosthetic aortic valve is expanded by the transcatheter bioprosthetic aortic valve to undergo a secondary deformation, and is coupled with the transcatheter bioprosthetic aortic valve while completing a final anchor coupling with the tissue at the aortic valve position of the patient; the first anchor state of the anchor stent of the transcatheter bioprosthetic aortic valve is an umbrella stent structure, including an outflow surface of a leaflet, an inflow surface of a leaflet, and a connection between the two, the outflow surface of the leaflet includes two or three anchor wire loops, and matches a true shape three-dimensionally reconstructed based on image data of the outflow surface of the leaflet of the patient; the inflow surface of the leaflet of the anchor stent of the transcatheter bioprosthetic aortic valve includes anchor wire loops corresponding to the wire loops of the outflow surface of the leaflet of the anchor stent, and can form a structure for clamping the leaflet with the anchor wire loops of the outflow surface of the leaflet of the anchor stent, and the shape matches a true shape three-dimensionally reconstructed based on subvalvular image data of the aortic valve of the patient; the connection part of the anchor stent of the transcatheter bioprosthetic aortic valve is a round-mouthed funnel-shaped lattice, and the inner diameter of the formed circumference matches an outer diameter of the stent of the transcatheter bioprosthetic aortic valve after it is released; The connecting portion of the anchor stent of the transcatheter prosthetic aortic valve has a cylindrical inner diameter that matches the outer diameter of the transcatheter prosthetic aortic valve in the second state. A separate, precisely anchorable transcatheter prosthetic aortic valve system.

2. The leaflet tissue of the aortic valve is a leaflet and a leaflet root tissue of the inflow surface of the valve.

2. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1.

3. The method further includes a transport assembly, the transport assembly including a transcatheter bioprosthetic aortic valve anchor stent transport kit and a transcatheter bioprosthetic aortic valve transport kit, the transcatheter bioprosthetic aortic valve anchor stent transport kit including a transport catheter and a transcatheter bioprosthetic aortic valve anchor stent loader.

2. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1.

4. The transcatheter bioprosthetic aortic valve is transported and released into the anchor stent of the transcatheter bioprosthetic aortic valve via a catheter, the stent deforms to expand the transcatheter bioprosthetic aortic valve to a functional state, and the anchor stent of the transcatheter bioprosthetic aortic valve is deformed again to fit the expanded transcatheter bioprosthetic aortic valve, while the anchor stent of the transcatheter bioprosthetic aortic valve is deformed again, whereby the anchor stent of the transcatheter bioprosthetic aortic valve reconnects with the diseased leaflets and subvalvular tissue, and the anchor stent of the transcatheter bioprosthetic aortic valve forms a clamping portion with the leaflets and the corresponding subvalvular tissue of the inflow surface, re-anchoring and restricting the transcatheter bioprosthetic aortic valve connected thereto.

2. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1.

5. The true structure of the aortic valve reconstructed three-dimensionally based on the patient's image data is a real model of a digital image model or a 3D printing simulation.

5. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1.

6. The true structure of the aortic valve reconstructed three-dimensionally based on the patient's image data is an anatomical structure simulating an aortic valve lesion, the digital image model is a simulated three-dimensional image model after digital conversion of the combined images of the patient's CT, ultrasound and nuclear magnetic resonance, and the simulation entity model is a corresponding 3D printed simulation entity model.

6. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 5.

7. an outflow surface of the leaflets of the anchor stent is a distal outflow end, an inflow surface of the leaflets of the transcatheter aortic valve anchor stent is a proximal inflow end, an anchor wire loop at the outflow end is a near-circular fold formed by extending a lattice of a connection part of the stent, a shape, size and fold angle of the anchor wire loop at the outflow end match a shape of a simulation of a lesion reconstructed three-dimensionally based on image data of a patient, the anchor wire loop at the inflow end is a small near-circular fold or a single row of diamond lattice structure, a shape, size and fold or single row of diamond lattice structure of the small near-circular fold at the inflow end match a shape and circumference of a simulation of a base part of a leaflet at the inflow end of an aortic valve reconstructed three-dimensionally based on image data of a patient, The connection part of the stent is a conical funnel lattice or three support bars connecting the inflow end and the outflow end, and the slope of the conical funnel matches the shape of a simulated aortic valve reconstructed three-dimensionally based on the patient's image data, and the true length from the lower edge of the coronary artery opening in the patient's image to the bottom of the leaflet at the inflow end of the aortic valve is the length of the connection part of the stent.

4. The separate, precisely anchorable transcatheter prosthetic aortic valve system of claim 3.

8. In the first anchoring state, the anchor stent of the transcatheter bioprosthetic aortic valve is released through the delivery catheter and then released from the compressed state, the anchor wire loop of the outflow end of the anchor stent of the transcatheter bioprosthetic aortic valve is folded back and extended into the valve pocket of the aortic valve leaflet of the patient's lesion, the small, quasi-circular folded back anchor wire loop corresponding to the inflow end is folded back on the base of the leaflet of the inflow end of the aortic valve of the lesion, the wire loops corresponding to both ends form an alignment clamp inside and outside, above and below the leaflet, the lattice of the stent connection part of the anchor stent of the transcatheter bioprosthetic aortic valve is released and recovers its shape, and forms a funnel shape at the intersection position of the aortic valve leaflet of the lesion, making the leaflet in an approximately normal opening and closing state; In the second anchoring state, the transcatheter bioprosthetic aortic valve transported by the transport catheter in the first anchoring state and held in a strip shape enters into the anchor stent of the transcatheter bioprosthetic aortic valve, expands by the balloon, and is released. The external force caused by the expansion of the balloon causes the transcatheter bioprosthetic aortic valve to expand from a strip shape to a cylindrical shape. At the same time, the anchor stent of the transcatheter bioprosthetic aortic valve undergoes a secondary deformation from a funnel shape to a cylindrical shape, and is tightly combined with the transcatheter bioprosthetic aortic valve. Then, the secondary deformation of the anchor stent of the transcatheter bioprosthetic aortic valve is again anchored with the aortic valve leaflets of the patient's lesion and the root tissue of the leaflets attached to the aortic wall, and finally.

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

9. a fixed support rod or a terminal bend of a stent for inserting the stent of the transcatheter bioprosthetic aortic valve is provided on both the outflow surface and the inflow surface of the connection part of the stent of the anchor stent of the transcatheter bioprosthetic aortic valve, the direction of the terminal bend of the fixed support rod or the stent is bent along the axis, and when the second anchor state is cylindrical, the distance between the terminal bends of the fixed support rod or the stent at both ends of the outflow surface and the inflow surface of the connection part of the stent of the anchor stent of the transcatheter bioprosthetic aortic valve matches the height of the stent of the transcatheter bioprosthetic aortic valve.

2. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1.

10. A plurality of terminal centripetal hooks for inserting the outflow end of the stent of the transcatheter bioprosthetic aortic valve are provided on both ends of the connection part of the stent of the anchor stent of the transcatheter bioprosthetic aortic valve, and these centripetal hooks are surrounded from above and below by a plurality of fixed support rods or terminal bends of a stent for inserting the inflow end of the transcatheter bioprosthetic aortic valve provided at the inflow end of the connection part of the stent of the anchor stent of the transcatheter bioprosthetic aortic valve, thereby making it possible to prevent the occurrence of displacement when the transcatheter bioprosthetic aortic valve is released.

10. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 9.

11. The number of terminal bends of the fixed support bar or stent is 3 to 12.

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

12. The stent connection part of the anchor stent of the transcatheter bioprosthetic aortic valve is a unit lattice consisting of a compressible diamond lattice or V-shaped lattice, and the stent connection part is adaptively connected to the anchor wire loops at both ends.

2. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1.

13. The outer periphery of the arc of the anchor wire loop of the inflow end of the anchor stent of the transcatheter prosthetic aortic valve is tightly coupled to the bottom of the aortic valve of the patient; 2. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1.

14. The surface of the anchor stent of the transcatheter prosthetic aortic valve is coated with a thin medical polymer film.

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

15. The anchor stent of the transcatheter bioprosthetic aortic valve is a three-dimensional molded structure after laser integral cutting or a separate connection structure; 3. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1 or 2.

16. The anchor stent of the transcatheter bioprosthetic aortic valve is made of nickel-titanium alloy material; 3. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1 or 2.

17. The stent is a cobalt-chromium alloy stent which assumes a cylindrical shape after being radially compressed and expanded by a balloon, or a nickel-titanium alloy stent which assumes a cylindrical shape after being radially compressed and self-expanding, the three leaflets are fan-shaped leaflets provided inside the three stents, each of the three leaflets has a free edge, an arc-shaped base and leaflet boundary connections extending on both sides, and the stent is a metal net tube.

4. The separate, precisely anchorable transcatheter prosthetic aortic valve system of claim 3.

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

20. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 17.

19. The transcatheter bioprosthetic aortic valve anchor stent is first transcatheterized to the aortic valve position of the lesion via a transport catheter and released to a first anchor state, and then the transcatheter bioprosthetic aortic valve is again transported to the transcatheter bioprosthetic aortic valve anchor stent via a transcatheter bioprosthetic aortic valve transport kit, and at the same time as the transcatheter bioprosthetic aortic valve expands, the transcatheter bioprosthetic aortic valve anchor stent expands to a second anchor state and engages with the transcatheter bioprosthetic aortic valve, completing further tight bonding with the perivalve and subvalve tissues to form a final anchor.

20. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 17.

20. The transcatheter bioprosthetic aortic valve transport kit includes a transcatheter bioprosthetic aortic valve transport device, a guide sheath, a valve leaflet gripper, and a charge pump.

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

21. The system is approached via a femoral artery, a carotid artery, a subclavian artery, or an apical approach route, and the transcatheter bioprosthetic aortic valve anchor stent and the transcatheter bioprosthetic aortic valve are approached front-to-back via the same route or front-to-back via separate routes.

2. The separate, precisely anchorable transcatheter bioprosthetic aortic valve system of claim 1.

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