A prosthetic valve anchoring device, assembly and transcatheter heart valve replacement system

Abstract

The present application relates to a kind of artificial valve anchoring device, assembly and transcatheter heart valve replacement system, when carrying out transcatheter heart valve replacement, first in turn implantation fishing ring and artificial valve anchoring device, the inflow end of artificial valve anchoring device has skirt part, can solve the problem of paravalvular leakage and reflux before artificial valve release;Artificial valve anchoring device also has two connecting arms, connecting arm can be inserted into the gap of autologous valve leaflet junction area, and is connected with fishing ring, will not affect the function and movement of autologous valve leaflet;The main part of artificial valve anchoring device can act together with fishing ring, and the complex structure of patient bicuspid / tricuspid is simplified into a standard circular channel, to provide a stable anchoring channel for artificial valve, the main part and artificial valve are connected by interference fit, when subsequent implantation artificial valve, artificial valve release height can also be adjusted according to the actual situation of patient.

Description

Technical Field

[0001] This invention relates to the field of medical devices for cardiac surgery, and more particularly to an artificial valve anchoring device, component, and transcatheter heart valve replacement system. Background Technology

[0002] Transcatheter valve replacement (TAVR), also known as percutaneous valve replacement, is an interventional treatment for stenosis or decompensation of heart valves. Compared to traditional open surgery, TAVR involves inserting a catheter through a blood vessel into the body, eliminating the need for open-chest surgery and reducing surgical trauma and recovery time.

[0003] 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, research has found that existing artificial valves have many problems in use:

[0004] (1) Artificial valves may obstruct the outflow tract of the aorta due to their low placement.

[0005] (2) Some existing solutions suggest that a “support frame” can be placed at the valve annulus first, and then the valve can be placed in the middle of the “support frame”. During the operation, the “support frame” will completely open the valve leaflets, making it impossible for the valve leaflets to open and close, and the valve function will completely fail. The patient’s life may be endangered because there is no time to implant an artificial valve.

[0006] (3) The anatomical structure of the human mitral or tricuspid valve is complex, and the anatomical structure varies greatly among different patients. Existing artificial valves are difficult to meet the needs of most patients. Summary of the Invention

[0007] This invention discloses an artificial valve anchoring device, component, and transcatheter heart valve replacement system, aiming to solve the technical problems existing in the prior art.

[0008] The present invention adopts the following technical solution:

[0009] On one hand, embodiments of the present invention provide an artificial valve anchoring device, characterized in that it includes a skirt portion, a main body portion and a connecting portion, which are arranged sequentially from the blood inflow end to the blood outflow end;

[0010] The skirt extends radially outward, and the small-diameter end of the skirt is connected to the main body.

[0011] The main body includes several interconnected polygonal mesh structures that can radially collapse and expand between radially collapsed and radially expanded structures;

[0012] The connecting part includes a connecting arm, which is folded from the blood outflow end to the blood inflow end and extends radially outward at an angle. The connecting arm is used to connect to or abut against the fishing ring.

[0013] As a preferred technical solution, the connecting part is provided with two connecting arms, which are arranged in a centrally symmetrical or asymmetrical manner.

[0014] As a preferred technical solution, the distribution of the two connecting arms matches the gap in the junction region of the autologous leaflets, so that the connecting arms can be inserted into the gap in the junction region of the autologous leaflets.

[0015] As a preferred technical solution, the connecting arm has a connecting end and a free end; the connecting end is provided with an arc-shaped chamfer, and the inner diameter of the arc-shaped chamfer is not less than the diameter of the coil cross-section of the fishing ring; the free end is used to pass through the coil gap of the fishing ring or to abut against the bottom of the fishing ring.

[0016] As a preferred technical solution, the free end extends outward in a straight, inclined manner, or the free end deflects clockwise or counterclockwise from the connecting end and extends outward in an inclined manner.

[0017] As a preferred technical solution, the angle between the free end and the main body is α1, where 30°≤α1≤90°.

[0018] As a preferred technical solution, a standard circular channel is defined in the middle of the main body.

[0019] As a preferred technical solution, the axial length of the main body is less than the axial length of the autologous leaflet.

[0020] As a preferred technical solution, the main body includes a shape memory material that can self-expand after being released into the heart.

[0021] As a preferred technical solution, the diameter of the large-diameter end of the skirt is larger than the diameter of the valve opening.

[0022] In a second aspect, embodiments of the present invention provide an artificial valve anchoring assembly, including the artificial valve anchoring device as described in any of the preceding claims, and further including a catching ring;

[0023] The catching ring is spiral-shaped and can be coiled around the chordae tendineae and connected to or abut against the artificial valve anchoring device.

[0024] As a preferred technical solution, the fishing ring is provided with an atrial segment and a functional segment in sequence;

[0025] The atrial segment can be covered by the skirt of the artificial valve anchoring device;

[0026] The functional segment includes a coil of several turns positioned at the original valve annulus for engaging with the main body of the artificial valve anchoring device. The gaps in the coil allow the connecting arm of the artificial valve anchoring device to pass through and connect to it. Alternatively, the coil located at the bottom of the functional segment abuts against the connecting arm of the artificial valve anchoring device.

[0027] Thirdly, embodiments of the present invention provide a transcatheter heart valve replacement system, including the artificial valve anchoring assembly as described above, and also including an artificial valve; the artificial valve and the main body of the artificial valve anchoring device are interference-fitted.

[0028] As a preferred technical solution, the artificial valve is configured as a self-expanding valve or a balloon-expandable valve.

[0029] The technical solution adopted in this invention can achieve the following beneficial effects:

[0030] This invention provides an artificial valve anchoring device that can be combined with a catching ring to form an artificial valve anchoring assembly. During transcatheter aortic valve replacement surgery, the catching ring and the artificial valve anchoring device are implanted sequentially. Because the inflow end of the artificial valve anchoring device has a skirt that completely covers and closely adheres to the orifice of the mitral / tricuspid valve, paravalvular leakage and regurgitation can be resolved before the artificial valve is released. The artificial valve anchoring device also has two connecting arms that can insert into the gap in the junctional region of the autologous valve leaflets and connect with the catching ring. The axial length of the main body of the artificial valve anchoring device is also specified. The axial length is smaller than that of the autologous valve leaflet, thus not affecting the function and movement of the autologous valve leaflet; the main body of the artificial valve anchoring device can work together with the catching ring to simplify the patient's complex mitral / 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 an interference fit, and because the main body has a certain height, the release height of the artificial valve can be adjusted according to the patient's actual situation during subsequent implantation. On the one hand, this can minimize obstruction of the outflow tract, and on the other hand, it can reduce the difficulty of the operation when releasing the artificial valve.

[0031] Another embodiment of the present invention further provides a transcatheter heart valve replacement system, including an artificial valve and the aforementioned artificial valve anchoring assembly. During heart valve replacement, a retrieval ring, an artificial valve anchoring device, and an artificial valve are implanted sequentially. Compared with the prior art, the retrieval ring and the artificial valve anchoring device in the present invention are implanted in two separate steps, which can effectively reduce the profile value of the delivery device, reduce the delivery difficulty, and reduce damage to the patient's blood vessels. The artificial valve can be a balloon-expandable valve, which is simpler to deliver than a self-expanding valve with a skirt, has a smaller profile value, requires less accuracy in release position, and is easier to operate. Compared with a self-expanding valve with leaflets, implanting the artificial valve anchoring device is easier, 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. Attached Figure Description

[0032] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0033] Figure 1 This is a schematic diagram of the structure of the fishing ring in one embodiment of the present invention (Example 1).

[0034] Figure 2 This is a top view of a fishing ring in one embodiment of the present invention, as disclosed in Embodiment 1.

[0035] Figure 3 This is a schematic diagram of the structure of the artificial valve anchoring device and the fishing ring in a mating state according to an embodiment of the present invention disclosed in Embodiment 1;

[0036] Figure 4 This is a schematic diagram of the artificial valve anchoring device and the fishing ring in a coordinated state at another angle in one embodiment of the present invention disclosed in Embodiment 1;

[0037] Figure 5 This is a top view of the artificial valve anchoring device and the fishing ring in a mating state in one embodiment of the present invention disclosed in Embodiment 1;

[0038] Figure 6 This is a schematic diagram of the structure of an artificial valve anchoring device in one embodiment of the present invention, as disclosed in Embodiment 1 of the present invention;

[0039] Figure 7 This is a top view of an artificial valve anchoring device in one embodiment of the present invention, as disclosed in Embodiment 1.

[0040] Figure 8This is a schematic diagram of the cooperation between the main body and the artificial valve in one embodiment of the present invention (Example 1).

[0041] Figure 9 This is a schematic diagram of the cooperation between the main body and the artificial valve in another embodiment of the present invention disclosed in Embodiment 1;

[0042] Figure 10 This is a schematic diagram of the retrieval ring in the artificial valve anchoring assembly during implantation in one embodiment of the present invention, as disclosed in Embodiment 2 of the present invention;

[0043] Figure 11 This is a schematic diagram of the artificial valve anchoring device in the artificial valve anchoring assembly during implantation, according to an embodiment of the present invention disclosed in Embodiment 2.

[0044] Figure 12 This is a schematic diagram of the implantation of an artificial valve in a transcatheter heart valve replacement system according to an embodiment of the present invention, as disclosed in Embodiment 3 of the present invention.

[0045] Figure 13 This is a schematic diagram of the structure of an artificial valve in one embodiment of the present invention, as disclosed in Embodiment 3 of the present invention;

[0046] Figure 14 This is a schematic diagram of the structure of a transcatheter heart valve replacement system in one embodiment of the present invention, as disclosed in Embodiment 3 of the present invention;

[0047] Figure 15 This is a schematic diagram illustrating the release of an artificial valve at other locations in a transcatheter heart valve replacement system according to an embodiment of the present invention disclosed in Embodiment 3;

[0048] Figure 16 This is a schematic diagram illustrating the release of the artificial valve at other locations in the transcatheter heart valve replacement system, as disclosed in another embodiment of Example 3 of the present invention.

[0049] Explanation of reference numerals in the attached figures:

[0050] Artificial valve anchoring device 10, skirt part 11, main body part 12, connecting arm 13, connecting end 131, free end 132, catching ring 20, atrial segment 21, functional segment 22, artificial valve 30, autologous leaflet 40. Detailed Implementation

[0051] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0052] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0053] Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0054] Example 1

[0055] This invention provides an artificial valve anchoring device 10, suitable for use within the mitral or tricuspid valve, and preferably used in conjunction with a retrieval ring 20, to address problems existing in the prior art. (Reference) Figure 1 — Figure 9 One end of the artificial valve anchoring device 10 is the blood inflow end, corresponding to the atrial side, and the other end is the blood outflow end. From the blood inflow end to the blood outflow end, there are a skirt part 11, a main body part 12 and a connecting part in sequence.

[0056] Since the artificial valve anchoring device 10 in this embodiment needs to be released after the fishing ring 20 is implanted, for ease of explanation, the structure of the fishing ring 20 will be partially described in this embodiment. However, those skilled in the art should understand that the artificial valve anchoring device 10 is an independent device and its structure does not include the fishing ring 20 itself.

[0057] like Figure 1 , Figure 2 In some embodiments, the retrieval ring 20 includes a spiral coil that, upon release, can be wound around the chordae tendineae of the mitral / tricuspid valve and position the artificial heart valve stent implanted within the mitral / tricuspid valve; in some embodiments, the retrieval ring 20 includes an atrial segment 21 and a functional segment 22, wherein the atrial segment 21 is located in the atrium and configured to generally follow the curvature of the atrial wall, and the functional segment 22 includes several turns of coil located at the native valve annulus for supporting the subsequently implanted artificial valve 30.

[0058] like Figure 3 — Figure 7In some embodiments, the skirt portion 11 extends radially outward in a flange shape, and its small diameter end is connected to the main body portion 12; the main body portion 12 is composed of several interconnected polygonal mesh structures, which can collapse radially during transport and expand radially after release; the connecting portion is provided with a connecting arm 13, which folds 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 abut against the catching ring 20.

[0059] In some embodiments, the skirt portion 11 includes several diamond-shaped mesh supports and elastic connectors. One end of the diamond-shaped mesh support is connected to the main body portion 12 via the elastic connector, and the other end can be releasably connected to a corresponding conveying device during conveying. After release, the skirt portion 11 can expand in a flower-like shape. 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 catching ring 20, so that the skirt portion 11 can completely cover the atrial segment 21 of the catching ring 20, further avoiding regurgitation at the valve annulus and possible paravalvular leakage. After the connecting arm 13 is connected to or abuts against the catching ring 20, the catching ring 20 pulls the artificial valve anchoring device 10 downward in the axial direction, so that the skirt portion 11 is further pressed against the valve orifice, which can further enhance the effect of preventing paravalvular leakage.

[0060] In some embodiments, the main body 12 includes one or more rows of polygonal grid structures, and adjacent grid structures are connected by elastic wave rods or nodes. The polygonal grid is preferably rhomboid, but pentagonal, hexagonal or other units that can form a closed shape can also be selected.

[0061] In some embodiments, an excessively long or short axial length of the main body 12 may have adverse effects. On the one hand, if the axial length of the main body 12 is too long, it may obstruct 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 deflect relative to the main body 12, causing them to become misaligned. Figure 9 This can lead to problems such as incomplete sealing. Therefore, the axial length of the main body 12 should be less than the axial length of the autologous valve leaflet. Preferably, only one row of polygonal grids is provided. The axial length of the main body 12 is preferably 3-8 mm. This ensures that the main body 12 does not affect the physiological function of the original valve tissue and that the artificial valve 30 is coaxial with the main body 12, avoiding undesirable deflection of the artificial valve 30. Figure 8 .

[0062] In some embodiments, the main body 12 has a cylindrical structure, with its outer side adapted to the functional segment 22 of the catching ring 20 and its inner side 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 original valve annulus 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 catching ring 20, so that the artificial valve 30 can be accurately released and work stably in subsequent operations, and ensure that the artificial valve 30 can be completely adapted to the shape of the valve annulus to avoid regurgitation.

[0063] In some embodiments, the inner diameter of the circular channel is larger than the outer diameter of the artificial valve 30, allowing for an interference fit. This ensures that the artificial valve 30 can stably connect with the artificial valve anchoring device 10 after deployment, preventing displacement of the artificial valve 30 during the cardiac cycle. Furthermore, during the procedure, the deployment height of the artificial valve 30 relative to the main body 12 can be flexibly adjusted according to the patient's outflow tract condition to minimize obstruction of the outflow tract and reduce the operational difficulty of deploying the artificial valve 30.

[0064] In some embodiments, when the artificial valve anchoring device 10 is applied to the tricuspid valve, the connecting portion preferably has three connecting arms 13; when the artificial valve anchoring device 10 is applied to the mitral valve, the connecting portion preferably has two connecting arms 13. The multiple connecting arms 13 may be centrally symmetrical or asymmetrically distributed. After the artificial valve anchoring device 10 is released, the connecting arms 13 extend radially outward and pass through the coil gap of the functional segment 22 of the fishing ring 20 to connect with it. Alternatively, the connecting arms 13 extend outward from the bottom of the functional segment 22 and abut against it to support the entire fishing ring 20.

[0065] 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 position of the two connecting arms 13 is preferably matched with the gap of the junction area of ​​the autologous leaflet 40, so that the connecting arms 13 can pass through the gap of the junction area of ​​the autologous leaflet 40 and connect with the catching ring 20. At this time, the presence of the connecting arms 13 will not obstruct the opening and closing movement of the patient's autologous leaflet 40, thereby avoiding the patient from losing mitral valve function during the operation, causing a large amount of regurgitation, and endangering life.

[0066] like Figure 6In 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, increasing the stability of the connection between the two. The free end 132 is used to pass through the coil gap of the fishing ring 20, and the free end 132 is preferably configured to have a rounded and blunt structure to prevent damage to the original valve tissue.

[0067] 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 pass between adjacent coils of the functional segment 22 of the fishing ring 20, or abut against the bottom coil of the functional segment 22. The portion of the connecting arm 13 exposed in the coil in the radial direction can extend upward at an angle to avoid large-area impact on other surrounding tissue structures.

[0068] In some embodiments, the free end 132 of the connecting arm 13 is configured to extend outward in a straight, inclined manner. In this case, after release, the connecting arm 13 can pass directly through the gap in the junction area of ​​the patient's own leaflet 40 and further penetrate into the gap of the adjacent coil, 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 in an inclined manner. The deflection structure can further increase the contact area between the connecting arm 13 and the coil, thereby further increasing the friction and ensuring the tightness of the connection between the two.

[0069] In some embodiments, when the connecting arm 13 is used to pass through 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 it after passing through the coil gap, increasing the friction between the two and preventing them 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, making it easier for the connecting arm 13 to pass through the coil gap.

[0070] In some embodiments, the skirt portion 11 and the main body portion 12 are connected by processes such as welding, sewing, riveting or integral molding, and the connecting portion and the main body portion 12 are also connected by processes such as welding, sewing, 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.

[0071] In some embodiments, the artificial valve anchoring device 10 achieves radial expansion of its deployment configuration via a balloon, and the entire device may be made of materials such as medical stainless steel and cobalt-chromium alloy.

[0072] In other embodiments, the artificial valve anchoring device 10 achieves radial expansion of its post-release configuration through self-expansion, wherein the device is made of shape memory material, preferably nickel-titanium alloy shape memory material or other shape memory polymer material or alloy.

[0073] In existing technologies, similar designs typically involve first implanting a stent during surgery as an "anchor" to fix the valve, and then placing the artificial valve 30 into the "anchor." However, during this process, the "anchor" completely expands the patient's own valve leaflet 40, preventing it from opening and closing normally, severely affecting the patient's cardiac function. Furthermore, this "anchor" cannot solve the problems of paravalvular leakage and regurgitation, which must be addressed by structures on the artificial valve 30 (such as the valve skirt). In addition, existing technologies require consideration of the positional relationship between the artificial valve 30 and the "anchor" 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 annulus must also be considered. Only when the valve skirt is tightly attached to the valve orifice can paravalvular leakage and regurgitation be prevented. Therefore, existing methods have extremely high requirements for the release position of the artificial valve 30, making the operation extremely difficult.

[0074] Compared with the prior art, the artificial valve anchoring device 10 provided in this embodiment allows doctors to flexibly adjust the release height of the artificial valve 30 according to the patient's actual situation after implantation, minimizing outflow tract obstruction. Furthermore, the artificial valve anchoring device 10, together with the catching ring 20, simplifies the complex mitral valve structure into a circular channel, providing a stable anchoring point for the artificial valve 30, and is suitable for the vast majority of patients. Because the artificial valve anchoring device 10 has a skirt portion 11, it can resolve paravalvular leakage and regurgitation issues before the artificial valve 30 is released. Moreover, after implantation of the catching ring 20 and the artificial valve anchoring device 10, it does not affect the normal function and movement of the valve leaflets, reducing surgical risks.

[0075] Example 2

[0076] This invention provides an artificial valve anchoring assembly, including a catching ring 20 and the artificial valve anchoring device 10 described in Embodiment 1 above. The technical features already included in Embodiment 1 are naturally inherited in this embodiment and will not be described in detail again.

[0077] In some embodiments, the retrieval ring 20 includes a core and a wrapping layer from the inside out. The core is made of pre-formed shape memory metal, which is capable of elastic deformation at least in the radial and axial directions to adapt to changes in the shape of myocardial tissue. The wrapping layer is made of a polymer material to provide friction. Furthermore, the retrieval ring 20 is also provided with a proximal connector and a imaging ring. The proximal connector is used for releasable connection with a delivery device that delivers the retrieval ring 20, and the imaging ring is used to observe and determine the position of the retrieval ring 20 during the operation.

[0078] Specifically, other structures or specific specifications / shapes of the fishing ring 20 can be referred to any of the embodiments disclosed in the prior art, and are not limited in this embodiment.

[0079] In this embodiment, taking the mitral valve as an example, the implantation process of the artificial valve 30 anchoring component is as follows: First, the retrieval ring 20 is implanted via a catheter, such as... Figure 10 At this point, because the retrieval ring 20 crosses the patient's valve orifice, mitral valve insufficiency and regurgitation may occur; next, an artificial valve anchoring device 10 is implanted via catheter, such as... Figure 11 First, align the connecting arm 13 with the gap at the junction of the patient's own leaflet 40. Then, move the artificial valve anchoring device 10 back and forth so that the connecting arm 13 can penetrate and hook the functional segment 22 of the retrieval ring 20. Next, cover the atrial segment 21 of the retrieval ring 20 with the skirt 11. Finally, release the artificial valve anchoring device 10. At this point, the artificial valve anchoring device 10 and the retrieval ring 20 are tightly fitted, and the skirt 11 of the occluder covers the patient's valve annulus, preventing abnormal phenomena such as regurgitation or paravalvular leakage. In addition, because the main body 12 of the occluder is relatively small and the connecting arm 13 is located in the gap at the junction of the patient's own leaflet 40, the retrieval ring 20 and the artificial valve anchoring device 10, after implantation, will not obstruct the opening and closing movement of the patient's own mitral valve leaflets, thereby preventing the patient from losing mitral valve function and experiencing massive regurgitation during the operation.

[0080] Example 3

[0081] This invention provides a transcatheter heart valve replacement system, such as... Figure 12 — Figure 16 The system includes an artificial valve 30 and the artificial valve anchoring component described in Embodiment 2 above. The technical features already included in Embodiments 1 and 2 above are naturally inherited in this embodiment and will not be described in detail again.

[0082] In some embodiments, the artificial valve 30 is released after the artificial valve anchoring assembly is implanted, and the artificial valve 30 is interference-fitted with the main body 12 of the artificial valve anchoring device 10.

[0083] likeFigure 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. By processing the above materials, several interconnected polygonal grid structures are formed. After being released in the heart, it can self-expand under the action of body temperature and restore its original shape. When configured as a balloon-expandable valve, the valve stent of the artificial valve 30 is made of materials such as medical stainless steel and cobalt-chromium alloy. Several interconnected polygonal grid structures are formed by pre-processing through weaving, welding, riveting, threaded connection, etc. During release, the artificial valve 30 is expanded by the force of balloon expansion. After the artificial valve 30 is expanded to the required extent, the balloon is withdrawn.

[0084] In this embodiment, the specific structure and operation of the artificial valve 30 can be selected from any of the embodiments disclosed in the prior art, and will not be specifically limited or described here.

[0085] In this embodiment, taking the mitral valve and balloon-expandable valve as examples, the operation process of the transcatheter heart valve replacement system is as follows: First, the retrieval ring 20 and the artificial valve anchoring device 10 are released sequentially, as detailed in Embodiment 2 above. Then, the artificial valve 30 is implanted via a catheter. The artificial valve 30 unfolds inside the artificial valve anchoring device 10, as shown in the example. Figure 12 Because 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, allowing the artificial valve 30 to be stably anchored inside the artificial valve anchoring device 10. Furthermore, the release height of the artificial valve 30 can be adjusted according to the patient's outflow tract condition. Figure 15 and Figure 16 To minimize obstruction of the outflow tract, the artificial valve 30 fits tightly with the artificial valve anchoring device 10. Under the action of the skirt part 11, the artificial valve 30 does not experience paravalvular leakage or regurgitation.

[0086] Compared to existing technologies, in this embodiment, the capture ring 20 and the artificial valve anchoring device 10 are implanted in two separate steps, which can effectively reduce the profile value of the delivery device, reduce the delivery difficulty, and reduce damage to the patient's blood vessels. The artificial valve 30 is a balloon-expandable valve, which is simpler to deliver than a self-expanding valve with a skirt, has a smaller profile value, requires less accuracy in the release position, and is easier to operate. Compared to a self-expanding valve with leaflets, implanting the artificial valve anchoring device 10 is easier, 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.

[0087] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of the present invention.

Claims

1. An artificial valve anchoring assembly, characterized in that, Includes artificial valve anchoring devices and catching rings; The fishing ring is provided with an atrium segment; The artificial valve anchoring device includes a skirt, a main body, and a connecting part, which are arranged sequentially from the blood inflow end to the blood outflow end. The skirt extends radially outward and is configured to completely cover and closely adhere to the valve orifice of the native valve before the artificial valve is released. The small-diameter end of the skirt is connected to the main body, and the diameter of the large-diameter end of the skirt is larger than the diameter of the atrial segment of the catching ring, so that the skirt can completely cover the atrial segment of the catching ring, thereby further avoiding regurgitation at the valve annulus and possible paravalvular leakage. The inner side of the main body is used to cooperate with the subsequently implanted artificial valve. It has only one row of polygonal grid structure in its axial direction, which can radially collapse and expand between the radial collapse structure and the radial expansion structure. The axial length of the main body is less than the axial length of the autologous valve leaflet, so as to avoid affecting the physiological function of the original valve tissue and blocking the outflow tract, and to avoid the artificial valve from deflecting undesirably, so that the two remain coaxial. The connecting part includes a connecting arm, which is folded from the blood outflow end to the blood inflow end and extends radially outward at an angle; When the artificial valve anchoring device is applied to the tricuspid valve, it has three connecting arms; when the artificial valve anchoring device is applied to the mitral valve, it has two connecting arms. The distribution of the connecting arms matches the gap in the junction area of ​​the autologous leaflets. The connecting arms are configured to pass through the gap in the junction area of ​​the autologous leaflets after release, so as to avoid obstructing the opening and closing movement of the autologous leaflets. The connecting arms are used to connect with or abut against the capture ring, and can be pulled downward in the axial direction by the capture ring after release, so that the skirt part is further pressed against the valve orifice of the original valve, so as to further enhance the effect of preventing paravalvular leakage.

2. The artificial valve anchoring assembly according to claim 1, characterized in that, When there are two connecting arms, the two connecting arms are arranged asymmetrically.

3. The artificial valve anchoring assembly according to claim 1, characterized in that, The connecting arm has a connecting end and a free end; the connecting end is provided with an arc-shaped chamfer, and the inner diameter of the arc-shaped chamfer is not less than the diameter of the coil cross-section of the fishing ring; the free end is used to pass through the coil gap of the fishing ring or abut against the bottom of the fishing ring.

4. The artificial valve anchoring assembly according to claim 3, characterized in that, The free end extends outward in a straight, inclined manner, or the free end deflects clockwise or counterclockwise from the connecting end and extends outward in an inclined manner.

5. The artificial valve anchoring assembly according to claim 3, characterized in that, The angle between the free end and the main body is α1, where 30°≤α1≤90°.

6. The artificial valve anchoring assembly according to claim 1, characterized in that, The main body has a standard circular channel defined in the middle.

7. The artificial valve anchoring assembly according to claim 1, characterized in that, The main body includes shape memory material that can self-expand after being released inside the heart.

8. The artificial valve anchoring assembly according to claim 1, characterized in that, The diameter of the large-diameter end of the skirt is greater than the diameter of the valve opening.

9. The artificial valve anchoring assembly according to claim 1, characterized in that, The catching ring is spiral-shaped and can be coiled around the chordae tendineae plexus and connected to or abutting the artificial valve anchoring assembly.

10. The artificial valve anchoring assembly according to claim 9, characterized in that, The fishing ring is provided with the atrium segment and the functional segment in sequence; The functional segment includes a coil of several turns positioned at the original valve annulus for engaging with the main body of the artificial valve anchoring device. The gaps in the coil allow the connecting arm of the artificial valve anchoring device to pass through and connect to it. Alternatively, the coil located at the bottom of the functional segment abuts against the connecting arm of the artificial valve anchoring device.

11. A transcatheter heart valve replacement system, characterized in that, Includes the artificial valve anchoring assembly as described in any one of claims 1-10, and further includes an artificial valve; The artificial valve and the main body of the artificial valve anchoring device are interference-fitted.

12. The transcatheter heart valve replacement system according to claim 11, characterized in that, The artificial valve is configured as a self-expanding valve or a balloon-expandable valve.

Images