WO2025214074A1 - Artificial valve anchoring device and assembly, and transcatheter heart valve replacement system - Google Patents

Abstract

The present invention relates to an artificial valve anchoring device and assembly, and a transcatheter heart valve replacement system. During transcatheter heart valve replacement, a capture ring and the artificial valve anchoring device are first implanted sequentially. An inflow end of the artificial valve anchoring device is provided with a skirt portion, which can address the problems of perivalvular leakage and regurgitation even before the artificial valve is released. The artificial valve anchoring device is also provided with two connecting arms, which are capable of penetrating gaps at the commissures of native valve leaflets and connecting to the capture ring, without affecting the function or movement of the native valve leaflets. A main body part of the artificial valve anchoring device can cooperate with the capture ring to simplify the patient's complex mitral/tricuspid valve structure into a standardized circular channel, providing a stable anchoring pathway for the artificial valve. The main body part and the artificial valve are connected by means of an interference fit. During subsequent implantation of the artificial valve, the release height of the artificial valve can also be adjusted according to the patient's actual situation.

Description

Artificial valve anchoring device, assembly and transcatheter heart valve replacement system Technical Field

The present invention relates to the field of medical devices for cardiac surgery, and in particular to an artificial valve anchoring device, components and a transcatheter heart valve replacement system.

Background Art

Transcatheter valve replacement, also known as percutaneous valve replacement (TAVR), is an interventional treatment for heart valve stenosis or decompensation. Compared with traditional open surgery, transcatheter valve replacement is inserted into the body through a catheter through blood vessels, without the need for open chest surgery, reducing surgical trauma and recovery time.

During transcatheter valve replacement surgery, doctors use a catheter to guide the artificial valve to the patient's heart and position it on the damaged valve. However, studies have found that existing artificial valves have many problems when used:

(1) The artificial valve may block the aortic outflow tract due to its low placement;

(2) Some existing plans currently propose placing a "support frame" at the valve annulus first, and then placing the valve in the middle of the "support frame". During the operation, the "support frame" will completely expand the valve leaflets, making it impossible for the patient's valve leaflets to open and close, and the valve function will completely fail. This will endanger the patient's life because there is no time to implant an artificial valve;

(3) The anatomical structure of the human mitral valve or tricuspid valve is complex and varies greatly from patient to patient. Existing artificial valves are difficult to adapt to the needs of most patients.

Summary of the Invention

The present invention discloses an artificial valve anchoring device, an assembly and a transcatheter heart valve replacement system, aiming to solve the technical problems existing in the prior art.

The present invention adopts the following technical solutions:

On the one hand, an embodiment of the present invention provides an artificial valve anchoring device, comprising a skirt portion, a main body portion, and a connecting portion, which are arranged in sequence from a blood inflow end to a blood outflow end;

The skirt portion is radially extended outward, and the small diameter end of the skirt portion is connected to the main body portion;

The main body portion includes a plurality of interconnected polygonal mesh structures capable of radially collapsing and expanding between a radially collapsed configuration and a radially expanded configuration;

The connecting portion comprises a connecting arm, which is folded from the blood outflow end to the blood inflow end and extends radially outwardly. The connecting arm is used to connect or abut with the fishing ring.

As a preferred technical solution, the connecting portion is provided with two connecting arms, and the two connecting arms are centrally symmetrically arranged or asymmetrically arranged.

As a preferred technical solution, the distribution positions of the two connecting arms match the gaps in the junction area of the native leaflets, so that the connecting arms can penetrate into the gaps in the junction area of the native leaflets.

As a preferred technical solution, the connecting arm has a connecting end and a free end; the connecting end is provided with an arc chamfer, and the inner diameter of the arc chamfer is not less than the coil cross-sectional diameter of the fishing ring; the free end is used to penetrate the coil gap of the fishing ring or abut against the bottom of the fishing ring.

As a preferred technical solution, the free end extends straight outward and obliquely, or the free end deflects clockwise or counterclockwise from the connecting end and extends outward and obliquely.

As a preferred technical solution, the included angle between the free end and the main body is α1, 30°≤α1≤90°.

As a preferred technical solution, a standard circular channel is defined in the middle of the main body.

As a preferred technical solution, the axial length of the main body is smaller than the axial length of the native valve leaflet.

As a preferred technical solution, the main body includes a shape memory material and can self-expand after being released in the heart.

As a preferred technical solution, the diameter of the large-diameter end of the skirt portion is larger than the diameter of the valve orifice.

In a second aspect, an embodiment of the present invention provides an artificial valve anchoring assembly, comprising the artificial valve anchoring device as described in any one of the above items, and further comprising a fishing ring;

The fishing ring is spiral-shaped and can be coiled outside the chordae tendineae plexus and connected to or abutted against the artificial valve anchoring device.

As a preferred technical solution, the fishing ring is provided with an atrial segment and a functional segment in sequence;

The atrial segment can be covered by the skirt portion of the prosthetic valve anchoring device;

The functional segment includes several turns of coils positioned at the native valve annulus, which are used to cooperate with the main body of the artificial valve anchoring device. The gaps in the coils allow the connecting arms of the artificial valve anchoring device to penetrate and connect with them, or the coils at the bottom of the functional segment abut against the connecting arms of the artificial valve anchoring device.

In a third aspect, an embodiment of the present invention provides a transcatheter heart valve replacement system, comprising the artificial valve anchoring assembly as described above, and an artificial valve; the artificial valve is interference-fitted with the main body of the artificial valve anchoring device.

As a preferred technical solution, the artificial valve is configured as a self-expanding valve or a balloon-expandable valve.

The technical solution adopted by the present invention can achieve the following beneficial effects:

The present invention provides an artificial valve anchoring device, which can form an artificial valve anchoring assembly together with a fishing ring; when performing transcatheter heart valve replacement, the fishing ring and the artificial valve anchoring device are first implanted in sequence, because the inflow end of the artificial valve anchoring device has a skirt portion, the skirt portion can completely cover and fit tightly against the valve orifice of the mitral valve/tricuspid valve, so that the problems of paravalvular leakage and regurgitation can be solved before the artificial valve is released; the artificial valve anchoring device also has two connecting arms, which can penetrate into the gap in the junction area of the native valve leaflets and connect with the fishing ring, and the axial length of the main body of the artificial valve anchoring device is 1.5mm. It is smaller than the axial length of the native leaflets, so as not to affect the function and movement of the native leaflets; the main body of the artificial valve anchoring device can work together with the capture ring to simplify the patient's complex mitral valve/tricuspid valve structure into a standard circular channel, providing a stable anchoring channel for the subsequent artificial valve. The main body and the artificial valve are connected by interference fit, and because the main body has a certain height, the release height of the artificial valve can be adjusted according to the actual situation of the patient when the artificial valve is subsequently implanted. On the one hand, it can avoid obstruction to the outflow tract to the greatest extent, and on the other hand, it also reduces the difficulty of operating the artificial valve during release.

Another embodiment of the present invention further provides a transcatheter heart valve replacement system, including an artificial valve and the above-mentioned artificial valve anchoring assembly. When performing heart valve replacement, a capture ring, an artificial valve anchoring device and an artificial valve are implanted in sequence. Compared with the existing technology, the capture ring and the artificial valve anchoring device in the present invention are implanted twice, which can effectively reduce the profile value of the delivery device, reduce the difficulty of delivery, and reduce damage to the patient's blood vessels; the artificial valve can be a balloon-expandable valve. Compared with a self-expanding valve with a skirt, the delivery system is simpler, the profile value is smaller, the accuracy requirement of the release position is low, and the operation difficulty is lower; compared with a self-expanding valve with leaflets, the difficulty of implanting an artificial valve anchoring device is lower, the length of the artificial valve anchoring device is shorter, the profile value of the delivery system is smaller, and the structure of the delivery system is simpler.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are provided to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

FIG1 is a schematic structural diagram of a fishing ring in an embodiment disclosed in Example 1 of the present invention;

FIG2 is a top view of a fishing ring according to an embodiment of the present invention disclosed in Example 1;

FIG3 is a schematic structural diagram of an artificial valve anchoring device and a fishing ring in a coordinated state in an embodiment disclosed in Example 1 of the present invention;

FIG4 is a structural schematic diagram of an artificial valve anchoring device and a fishing ring in a mating state at another angle according to an embodiment of the present invention disclosed in Example 1;

FIG5 is a top view of an artificial valve anchoring device and a fishing ring in a mating state according to an embodiment of the present invention disclosed in Example 1;

FIG6 is a schematic structural diagram of an artificial valve anchoring device according to an embodiment of the present invention disclosed in Example 1;

FIG7 is a top view of an artificial valve anchoring device according to an embodiment of the present invention disclosed in Example 1;

FIG8 is a schematic diagram of the coordination between the main body and the artificial valve according to an embodiment of the present invention disclosed in Example 1;

FIG9 is a schematic diagram of the cooperation between the main body and the artificial valve in another embodiment disclosed in Example 1 of the present invention;

FIG10 is a schematic diagram of a fishing ring in an artificial valve anchoring assembly during implantation according to an embodiment of the present invention disclosed in Example 2;

FIG11 is a schematic diagram of an artificial valve anchoring device in an artificial valve anchoring assembly during implantation according to an embodiment of the present invention disclosed in Example 2;

FIG12 is a schematic diagram of an artificial valve in a transcatheter heart valve replacement system during implantation according to an embodiment of the present invention disclosed in Example 3;

FIG13 is a schematic structural diagram of an artificial valve in an embodiment disclosed in Example 3 of the present invention;

FIG14 is a schematic structural diagram of a transcatheter heart valve replacement system according to an embodiment of the present invention disclosed in Example 3;

FIG15 is a schematic diagram of the release of an artificial valve in other positions of the transcatheter heart valve replacement system according to an embodiment of the present invention disclosed in Example 3;

FIG16 is a schematic diagram showing the release of an artificial valve at other positions of a transcatheter heart valve replacement system in another embodiment disclosed in Example 3 of the present invention.

Description of reference numerals:

Artificial valve anchoring device 10, skirt portion 11, main body portion 12, connecting arm 13, connecting end 131, free end 132, capturing ring 20, atrial segment 21, functional segment 22, artificial valve 30, and native valve leaflet 40.

DETAILED DESCRIPTION

To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and/or" unless the content clearly indicates otherwise.

In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be internal communication between two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. In addition, in the description of this application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

Example 1

An embodiment of the present invention provides a prosthetic valve anchoring device 10 suitable for use within the mitral or tricuspid valve, preferably used in conjunction with a fishing ring 20 to address the problems existing in the prior art. Referring to Figures 1-9 , the prosthetic valve anchoring device 10 has one end as the blood inflow end, corresponding to the atrial side, and the other end as the blood outflow end. From the blood inflow end to the blood outflow end, the device is sequentially provided with a skirt portion 11, a main body portion 12, and a connecting portion.

Since the artificial valve anchoring device 10 in this embodiment needs to be released after the capture ring 20 is implanted, for the sake of convenience, the structure of the capture ring 20 will be partially described in this embodiment, but those skilled in the art should understand that the artificial valve anchoring device 10 is an independent device, and its structural composition does not include the capture ring 20 itself.

As shown in Figures 1 and 2, in some embodiments, the capture ring 20 includes a spiral coil that can be coiled around the chordae tendineae of the mitral valve/tricuspid valve after release, and position the artificial heart valve stent implanted in the mitral valve/tricuspid valve; in some embodiments, the capture ring 20 includes an atrial segment 21 and a functional segment 22, wherein the atrial segment 21 is positioned in the atrium and is configured to be curved roughly following the curvature of the atrial wall, and the functional segment 22 includes several turns of coils positioned at the native valve annulus for supporting the subsequently implanted artificial valve 30.

As shown in Figures 3 to 7, in some embodiments, the skirt portion 11 extends radially outward in a flange shape, and its small diameter end is connected to the main body 12; the main body 12 is composed of a number of interconnected polygonal grid structures, which can radially collapse during transportation and radially expand after release; the connecting portion is provided with a connecting arm 13, which is folded from the blood outflow end to the blood inflow end and extends radially outward at an angle, and the connecting arm 13 can be connected to or abutted against the fishing ring 20.

In some embodiments, the skirt portion 11 includes several diamond-shaped grid support members and elastic connectors. One end of the diamond-shaped grid support member is connected to the main body 12 by an elastic connector, and the other end can be releasably connected to the corresponding delivery device during delivery; the skirt portion 11 can expand in a flower-like manner after release, and the skirt portion 11 is preferably larger than the diameter of the valve orifice to ensure complete coverage of the valve orifice, thereby preventing paravalvular leakage; in some embodiments, the diameter of the large-diameter end of the skirt portion 11 is larger than the diameter of the atrial segment 21 of the capture ring 20, so that the skirt portion 11 can completely cover the atrial segment 21 of the capture ring 20, so as to further avoid regurgitation and possible paravalvular leakage at the valve annulus; after the connecting arm 13 is connected or abutted with the capture ring 20, the capture ring 20 will pull the artificial valve anchoring device 10 downward in the axial direction, so that the skirt portion 11 is further close to the valve orifice, which can further enhance the effect of preventing paravalvular leakage.

In some embodiments, the main body 12 includes one to several rows of polygonal grid structures, and adjacent grid structures are connected by wave rods or nodes with a certain degree of elasticity. The polygonal grid is preferably a rhombus, and pentagons, hexagons, etc. can also be selected to form closed-shaped units.

In some embodiments, the axial length of the main body 12 may be too long or too short, which may cause adverse effects. On the one hand, if the axial length of the main body 12 is too long, it may block the outflow tract or hinder the opening and closing of the leaflets. On the other hand, if the axial length of the main body 12 is too short, the artificial valve 30 may be deflected relative to the main body 12, making the two not coaxial, as shown in Figure 9, resulting in consequences such as loose sealing. Therefore, the axial length of the main body 12 should be less than the axial length of the native leaflets. Preferably, only one row of polygonal grids is provided. The axial length of the main body 12 is preferably 3-8 mm, which can ensure that the main body 12 will not affect the physiological function of the native valve tissue, and can also ensure that the artificial valve 30 is coaxial with the main body 12, avoiding unexpected deflection of the artificial valve 30, as shown in Figure 8.

In some embodiments, the main body 12 has a cylindrical structure, the outer side of which is adapted to the functional segment 22 of the capture ring 20, and the inner side is adapted to the artificial valve 30. A standard circular channel is defined in the middle of the inner side of the main body 12. At this time, no matter what irregular shape the cross-section of the patient's native valve ring is, it can be adjusted to a standard circle under the joint action of the main body 12 and the functional segment 22 of the capture ring 20, so that the artificial valve 30 can be accurately released and work stably during subsequent operations, and ensure that the artificial valve 30 can be fully adapted to the shape of the valve ring to avoid reflux.

In some embodiments, the inner diameter of the circular channel is larger than the outer diameter of the prosthetic valve 30, allowing for an interference fit between the two. This ensures that the prosthetic valve 30 is stably connected to the prosthetic valve anchoring device 10 after release, preventing displacement of the prosthetic valve 30 during the cardiac cycle. Furthermore, during surgery, the release height of the prosthetic valve 30 relative to the main body 12 can be flexibly adjusted based on the patient's outflow tract condition to minimize outflow tract obstruction and reduce the operational difficulty of releasing the prosthetic valve 30.

In some embodiments, when the artificial valve anchoring device 10 is suitable for the tricuspid valve, the connecting portion is preferably provided with three connecting arms 13; when the artificial valve anchoring device 10 is suitable for the mitral valve, the connecting portion is preferably provided with two connecting arms 13. The multiple connecting arms 13 can be distributed in a centrally symmetrical or asymmetrical manner. After the artificial valve anchoring device 10 is released, the connecting arms 13 extend radially outward and penetrate into the coil gap of the functional segment 22 of the capturing ring 20 to connect therewith, or, the connecting arms 13 extend outward from the bottom of the functional segment 22 and abut against it to support the entire capturing ring 20.

In some embodiments, the artificial valve anchoring device 10 is suitable for the mitral valve, and the connecting part has two connecting arms 13. Since the human mitral valve leaflets are not completely symmetrical, the distribution positions of the two connecting arms 13 are preferably matched with the gaps in the junction area of the native leaflets 40, so that the connecting arms 13 can pass through the gaps in the junction area of the native leaflets 40 and connect to the capturing ring 20. At this time, the presence of the connecting arms 13 will not block the opening and closing movement of the patient's native leaflets 40, thereby avoiding the patient losing mitral valve function during the operation, causing a large amount of regurgitation, and endangering life.

As shown in Figure 6, in some embodiments, the connecting arm 13 has a connecting end 131 and a free end 132. The connecting end 131 has an arc-shaped chamfer, and the inner diameter of the arc-shaped chamfer is not less than the cross-sectional diameter of the coil of the fishing ring 20, so that when the connecting arm 13 is connected to the fishing ring 20, the coil can fall into the arc-shaped chamfer, thereby increasing the stability of the connection between the two; the free end 132 is used to penetrate the coil gap of the fishing ring 20, and the free end 132 is preferably configured as a rounded blunt structure to prevent damage to the native valve tissue.

In some embodiments, the angle between the free end 132 and the main body 12 is α1, 30°≤α1≤90°, to ensure that after the artificial valve anchoring device 10 is released, the connecting arm 13 can smoothly penetrate between the adjacent coils of the functional segment 22 of the capture ring 20, or abut against the bottom coil of the functional segment 22, and the part of the connecting arm 13 radially exposed to the coil can extend upward at an angle to avoid affecting other surrounding tissue structures over a large area.

In some embodiments, the free end 132 of the connecting arm 13 is configured to extend straight outward at an angle. At this time, the connecting arm 13 can pass straight through the gap in the junction area of the patient's own valve leaflets 40 after being released, and further penetrate into the gap between adjacent coils, or abut against the bottom coil of the functional segment 22; in other embodiments, the free end 132 of the connecting arm 13 is deflected clockwise or counterclockwise from the connecting end 131 and extends outward at an angle. The deflected structure can further increase the contact area between the connecting arm 13 and the coil, thereby further increasing the friction force and ensuring the tightness of the combination of the two.

In some embodiments, when the connecting arm 13 is used to penetrate the coil gap of the fishing ring 20, the cross-sectional thickness of the connecting arm 13 is not less than the gap between adjacent coils of the functional segment 22 of the fishing ring 20, so as to ensure that the connecting arm 13 forms a stable interference connection with the coil after penetrating the coil gap, thereby increasing the friction between the two and preventing the two from separating; in other embodiments, the cross-sectional thickness of the connecting arm 13 is less than the gap between adjacent coils of the functional segment 22 of the fishing ring 20, so that the connecting arm 13 can pass through the gap of the coil more easily.

In some embodiments, the skirt portion 11 and the main body portion 12 are connected by welding, suturing, riveting or integral molding, and the connecting portion and the main body portion 12 are also connected by welding, suturing, riveting or integral molding. The three are preferably made of the same material and are in a cylindrical compressed state when transported in the blood vessels, and are opened by self-expansion or balloon expansion after reaching the heart.

In some embodiments, the artificial valve anchoring device 10 achieves radial expansion of its released configuration through a balloon. In this case, the entire device can be made of materials such as medical stainless steel and cobalt-chromium alloy.

In other embodiments, the artificial valve anchoring device 10 achieves radial expansion of its released configuration by self-expansion. In this case, the device is made of a shape memory material, preferably a nickel-titanium alloy memory material or other memory polymer materials or alloys.

In the prior art, similar design schemes generally involve first implanting a stent as an "anchoring frame" to fix the valve during surgery, and then placing the artificial valve 30 into the "anchoring frame". However, in this process, the "anchoring frame" will completely expand the patient's autologous valve leaflets 40, preventing them from opening and closing normally, seriously affecting the patient's heart function. Moreover, this "anchoring frame" cannot solve the problems of paravalvular leakage and regurgitation, and must rely on the structure on the artificial valve 30 (such as a valve skirt) to solve these problems. In addition, the schemes in the prior art also need to consider the positional relationship between the artificial valve 30 and the "anchoring frame" when releasing the artificial valve 30. Only when the artificial valve 30 is placed in the appropriate position can it be stably anchored. At the same time, the positional relationship between the artificial valve 30 and the patient's valve ring also needs to be considered. Only when the valve skirt is close to the valve orifice can paravalvular leakage and regurgitation be prevented. Therefore, the existing schemes have extremely high requirements for the release position of the artificial valve 30 and are extremely difficult to operate.

Compared with the prior art, the artificial valve anchoring device 10 provided in this embodiment allows the doctor to flexibly adjust the release height of the artificial valve 30 according to the actual situation of the patient after implantation, thereby avoiding outflow tract obstruction to the greatest extent; and the artificial valve anchoring device 10 and the capture ring 20 work together to simplify the complex mitral valve structure into a circular channel, providing a stable anchoring point for the artificial valve 30, and can be suitable for most patients; because the artificial valve anchoring device 10 has a skirt portion 11, it can solve the problems of paravalvular leakage and regurgitation before the artificial valve 30 is released, and after the capture ring 20 and the artificial valve anchoring device 10 are implanted, it will not affect the normal function and movement of the patient's valve leaflets, thereby reducing the surgical risk.

Example 2

An embodiment of the present invention provides an artificial valve anchoring assembly, including a fishing ring 20 and the artificial valve anchoring device 10 described in the above embodiment 1. The technical features already included in the above embodiment 1 are naturally inherited in this embodiment and will not be repeated one by one.

In some embodiments, the capture ring 20 includes a core and a wrapping layer from the inside to the outside. The core is made of preformed memory metal, which can undergo elastic deformation in at least the radial and axial directions to adapt to the changes in the shape of the myocardial tissue. The wrapping layer is made of a polymer material and is used to provide friction. Furthermore, the capture ring 20 is also provided with a proximal connector and a developing ring. The proximal connector is used to be releasably connected to a conveying device that delivers the capture ring 20, and the developing ring is used to observe and determine the position of the capture ring 20 during the operation.

Specifically, other structures or specific specifications/shapes of the fishing ring 20 can refer to any embodiment disclosed in the prior art and are not limited in this embodiment.

In this embodiment, taking the mitral valve as an example, the implantation process of the artificial valve 30 anchoring component is specifically as follows: first, the capture ring 20 is implanted through a transcatheter method, as shown in Figure 10. At this time, since the capture ring 20 crosses the patient's valve orifice, it may cause mitral valve insufficiency and regurgitation; next, the artificial valve anchoring device 10 is implanted through a transcatheter method, as shown in Figure 11. First, the connecting arm 13 is aligned with the gap in the junction area of the patient's own valve leaflets 40, and then the artificial valve anchoring device 10 is moved back and forth so that the connecting arm 13 can penetrate and hook the functional segment 22 of the capture ring 20, and then the skirt portion 11 covers the atrial segment 21 of the capture ring 20, and finally the artificial valve anchoring device 10 is released. At this time, the artificial valve anchoring device 10 fits tightly with the capturing ring 20, and the skirt portion 11 of the occluding frame covers the patient's valve ring, so abnormal phenomena such as regurgitation or paravalvular leakage will not occur. In addition, since the main body 12 of the occluding frame is relatively small in height, the connecting arm 13 is located in the gap at the junction of the patient's own valve leaflets 40. After the capturing ring 20 and the artificial valve anchoring device 10 are implanted, they will not hinder the opening and closing movement of the patient's own mitral valve leaflets, thereby avoiding the patient from losing mitral valve function during the operation and causing a large amount of regurgitation.

Example 3

An embodiment of the present invention provides a transcatheter heart valve replacement system, as shown in Figures 12 to 16. The system includes an artificial valve 30 and the artificial valve anchoring assembly described in the above-mentioned embodiment 2. The technical features already included in the above-mentioned embodiments 1 and 2 are naturally inherited in this embodiment and will not be repeated one by one.

In some embodiments, the artificial valve 30 is released after the artificial valve anchoring assembly is implanted, and the artificial valve 30 is interference fit with the main body 12 of the artificial valve anchoring device 10 .

As shown in Figure 13, in some embodiments, the artificial valve 30 is configured as a self-expanding valve or a balloon-expandable valve; when configured as a self-expanding valve, the valve stent of the artificial valve 30 is made of metal or polymer materials, such as nickel-titanium alloy memory material or other memory polymer materials or alloys, and the above materials are processed to form a number of interconnected polygonal grid structures, which can self-expand under the action of body temperature and restore their original properties after being released in the heart; when configured as a balloon-expandable valve, the valve stent of the artificial valve 30 is made of medical stainless steel and cobalt-chromium alloy and other materials, and is pre-processed by weaving, welding, riveting, threading, etc. to form a number of interconnected polygonal grid structures, and when released, the expansion of the artificial valve 30 is achieved by the force of the balloon expansion, and when the artificial valve 30 expands to the required extent, the balloon is withdrawn.

In this embodiment, the specific structure and operation mode of the artificial valve 30 can be selected from any embodiment disclosed in the prior art, and will not be specifically limited or elaborated herein.

In this embodiment, taking the mitral valve and balloon-expandable valve as examples, the operation process of the transcatheter heart valve replacement system is specifically as follows: first, the capture ring 20 and the artificial valve anchoring device 10 are released in sequence, and the specific operation process is shown in the above-mentioned embodiment 2. Then, the artificial valve 30 is implanted through a transcatheter method, and the artificial valve 30 is unfolded inside the artificial valve anchoring device 10, as shown in Figure 12. Since the outer diameter of the artificial valve 30 is larger than the inner diameter of the main body 12 of the artificial valve anchoring device 10, the two can achieve an interference fit, so that the artificial valve 30 can be stably anchored inside the artificial valve anchoring device 10. The release height of the artificial valve 30 can also be adjusted according to the patient's outflow tract condition, as shown in Figures 15 and 16, to minimize outflow tract obstruction. At this time, the artificial valve 30 is tightly fitted with the artificial valve anchoring device 10. Under the action of the skirt 11, the artificial valve 30 has no paravalvular leakage or regurgitation.

Compared with the existing technology, the capture ring 20 and the artificial valve anchoring device 10 in this embodiment are implanted twice, which can effectively reduce the profile value of the delivery device, reduce the difficulty of delivery, and reduce damage to the patient's blood vessels; the artificial valve 30 selects a balloon-expandable valve. Compared with the self-expanding valve with a skirt, the delivery system is simpler, the profile value is smaller, the accuracy requirement of the release position is low, and the operation difficulty is lower; compared with the self-expanding valve with leaflets, the difficulty of implanting the artificial valve anchoring device 10 is lower, the length of the artificial valve anchoring device 10 is shorter, the profile value of the delivery system is smaller, and the structure of the delivery system is simpler.

The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are protected by the present invention.

Claims (14)

An artificial valve anchoring device, characterized in that it comprises a skirt portion, a main body portion and a connecting portion, which are arranged in sequence from a blood inflow end to a blood outflow end; The skirt portion is radially extended outward, and the small diameter end of the skirt portion is connected to the main body portion; The main body portion includes a plurality of interconnected polygonal mesh structures capable of radially collapsing and expanding between a radially collapsed configuration and a radially expanded configuration; The connecting portion includes a connecting arm, which is folded from the blood outflow end to the blood inflow end and extends radially outwardly. The connecting arm is used to connect with or abut against the fishing ring. The artificial valve anchoring device according to claim 1 is characterized in that the connecting portion is provided with two connecting arms, and the two connecting arms are centrally symmetrically arranged or asymmetrically arranged. The artificial valve anchoring device according to claim 2 is characterized in that the distribution positions of the two connecting arms match the gaps in the junction area of the native leaflets, so that the connecting arms can penetrate into the gaps in the junction area of the native leaflets. The artificial valve anchoring device according to claim 1 is characterized in that the connecting arm has a connecting end and a free end; the connecting end is provided with an arc chamfer, and the inner diameter of the arc of the arc chamfer is not less than the coil cross-sectional diameter of the capturing ring; the free end is used to penetrate the coil gap of the capturing ring or abut against the bottom of the capturing ring. The artificial valve anchoring device according to claim 4 is characterized in that the free end extends straight outward and obliquely, or the free end deflects clockwise or counterclockwise from the connecting end and extends outward and obliquely. The artificial valve anchoring device according to claim 4 is characterized in that the angle between the free end and the main body is α1, 30°≤α1≤90°. The artificial valve anchoring device according to claim 1 is characterized in that a standard circular channel is defined in the middle of the main body. The artificial valve anchoring device according to claim 1 is characterized in that the axial length of the main body is smaller than the axial length of the native valve leaflet. The artificial valve anchoring device according to claim 1 is characterized in that the main body comprises a shape memory material and can self-expand after being released in the heart. The artificial valve anchoring device according to claim 1 is characterized in that the diameter of the large diameter end of the skirt portion is larger than the diameter of the valve orifice. An artificial valve anchoring assembly, characterized in that it comprises the artificial valve anchoring device according to any one of claims 1 to 10, and further comprises a fishing ring; The fishing ring is spiral-shaped and can be coiled outside the chordae tendineae plexus and connected to or abutted against the artificial valve anchoring device. The artificial valve anchoring assembly according to claim 11, wherein the fishing ring is provided with an atrial segment and a functional segment in sequence; The atrial segment can be covered by the skirt portion of the artificial valve anchoring device; The functional segment includes several turns of coils positioned at the native valve annulus, which are used to cooperate with the main body of the artificial valve anchoring device. The gaps in the coils allow the connecting arms of the artificial valve anchoring device to penetrate and connect with them, or the coils located at the bottom of the functional segment abut against the connecting arms of the artificial valve anchoring device. A transcatheter heart valve replacement system, comprising the artificial valve anchoring assembly according to claim 12, and further comprising an artificial valve; The artificial valve is interference-fitted with the main body of the artificial valve anchoring device. The transcatheter heart valve replacement system according to claim 13, wherein the artificial valve is configured as a self-expanding valve or a balloon-expandable valve.