Surgical artificial heart valve

Abstract

The present application discloses a surgical artificial heart valve, which has a support structure and a plurality of valve leaflets. The support structure is generally annular, and the inside of the annulus is a blood flow passage. The support structure has an inlet side and an outlet side opposite to each other along the annular axis. The plurality of valve leaflets are connected to the support structure to control the on-off state of the blood flow passage. The support structure includes: a first annular band and a second annular band. In the first annular band and the second annular band, each annular band is circumferentially spaced with a deformation section that allows the corresponding annular band to expand in diameter. The surgical artificial heart valve realizes the expansion of the annular band through the deformation section, thereby solving the problem of postoperative variation in valve-in-valve surgery.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to surgical artificial heart valves. Background Art

[0002] Aortic valve diseases, especially aortic stenosis, have a high mortality rate, imposing a huge burden on healthcare systems worldwide. The common treatment for diseased aortic valves is replacement with an artificial valve. Different from mitral and tricuspid valve diseases, diseased aortic valves are almost always replaced rather than repaired.

[0003] The two major categories of bioprosthetic aortic valve replacement are surgical replacement and transcatheter interventional replacement. Due to the lack of long-term durability data for transcatheter valves, young patients (e.g., under 65 years old) and patients with low surgical risk are usually treated with surgically replaced heart valves. The long-term durability of surgical valves is currently in the range of 10 - 20 years. In other words, during the patient's life cycle, the surgical valve may fail, resulting in the need to replace another valve. One strategy for treating failed surgical valves is the Valve-in-Valve (ViV) interventional procedure. In the ViV procedure, a new transcatheter interventional heart valve is deployed within the existing failed surgical valve, thus avoiding the patient having to undergo another invasive surgical valve replacement.

[0004] One of the main challenges of the ViV procedure is post-procedural gradients. Since the transcatheter implanted interventional heart valve (THV) is deployed into the failed surgical valve, and the surgical valve usually has a non-compliant structure, the expansion of the THV is restricted. Due to the thickness of the THV's frame and other structures, the flow orifice of the newly implanted THV is inherently smaller than that of the existing surgical valve. As a result, the newly implanted THV may suffer from insufficient blood flow, failure to reach the expected valve diameter, which affects the opening of the valve leaflets, leading to adverse effects such as high pressure gradients. Seriously, it may further affect the service life of the interventional valve.

[0005] There are various strategies to improve the ViV gradient to an acceptable level. One strategy is known as bioprosthetic valve fracture (BVF), or commonly referred to as "fracking". During BVF surgery, before or after THV deployment, a high-pressure balloon is inserted into the lumen of one or more valves and inflated to a high enough pressure to disrupt the structure of the failing surgical valve, allowing for greater expansion of the THV. This procedure requires off-label use of a high-pressure balloon, typically inflated to 4 times or more its rated burst pressure, increasing patient risk and reducing safety. Additionally, during BVF, the rupture of the failing surgical valve structure is rapid and uncontrolled, thus exposing the patient to a high risk of annular rupture. Moreover, not all surgical valves can be "fracked" in this way.

[0006] Another strategy for improving the gradient after ViV is to use a surgically implanted heart valve that is designed to expand without high-pressure BVF during ViV deployment using a balloon-expandable THV valve. However, this surgically implanted valve faces several challenges, which present opportunities for improvement. First, the cobalt-chrome "stiffener band" has only one expansion joint. This leads to the possibility of asymmetric expansion during ViV, resulting in a possible asymmetric, out-of-round condition, or possible tearing of the valve fabric due to movement of the stiffener band within the valve fabric during asymmetric expansion. This can lead to embolization of fabric particles in the case of fabric tearing or asymmetric transcatheter deployment. Additionally, the surgically implanted valve has no predefined expansion limit. Ideally, a surgically implanted valve optimized for valve-in-valve deployment would expand a predetermined amount and then prevent further expansion. This would ensure a high level of radial force between the two artificial heart valves and reduce the likelihood of THV migration or embolization.

[0007] Therefore, for optimal subsequent valve-in-valve surgery, an ideal surgically implanted valve would be designed to include the following features:

[0008] A commercially available balloon that is easy to expand at low pressure within its labeled pressure-use parameters, either before or after ViV.

[0009] Predictable, uniform, controlled, balloon-pressure-proportional expansion around the surgically implanted valve.

[0010] A predefined expansion limit to ensure sufficient retention force for the THV.

[0011] An interlocking feature to help retain the THV and prevent migration or embolization. Summary of the Invention

[0012] The present invention relates to a novel surgical valve prosthesis for treating aortic stenosis and / or regurgitation, which attempts to provide the above-mentioned features.

[0013] To solve the above technical problems, the present invention discloses a surgical artificial heart valve, including a support structure and a plurality of valve leaflets. The support structure is generally annular, and the inside of the annulus is a blood flow channel. The support structure has opposite inflow and outflow sides along the annular axis. The plurality of valve leaflets are connected to the support structure. The support structure includes:

[0014] A first annular band, on which a plurality of extension strips extending towards the outflow side and circumferentially spaced apart are provided, and the joint of adjacent valve leaflets matches the corresponding extension strip;

[0015] A second annular band, which is attached and fixed to the inner or outer side of the first annular band and is adjacent to the inflow side of the first annular band; and

[0016] In the first annular band and the second annular band, each annular band is circumferentially spaced with deformation segments allowing the expansion of the annular band where it is located.

[0017] The present application also discloses a surgical artificial heart valve, including a support structure and a plurality of valve leaflets. The support structure is generally annular, and the inside of the annulus is a blood flow channel. The support structure has opposite inflow and outflow sides along the annular axis. The plurality of valve leaflets are connected to the support structure. Wherein the support structure includes:

[0018] A first annular band, on which a plurality of extension strips extending towards the outflow side and circumferentially spaced apart are provided, and the joint of adjacent valve leaflets matches the corresponding extension strip;

[0019] A second annular band, which is attached and fixed to the inner or outer side of the first annular band and is adjacent to the inflow side of the first annular band;

[0020] Wherein in the first annular band and the second annular band, the strength of the second annular band is higher than that of the first annular band. Each annular band is circumferentially spaced with deformation segments allowing the expansion of the annular band where it is located. The number of deformation segments on each annular band is the same as the number of extension strips and the positions correspond. As described below, several optional and modified ways are provided, but they are not additional limitations to the above general solution, but only further supplements or modifications.

[0021] Optionally, the circumferential positions of the deformation segments on the two annular bands are aligned with each other.

[0022] Optionally, a part of each annular band has an open meandering structure, which serves as the deformation section.

[0023] Optionally, a tension member is connected between the two annular bands, and the connection part of the tension member is adjacent to the deformation section of each annular band.

[0024] Optionally, the circumferential positions of the deformation sections on the first annular band correspond one-to-one with the extension strips.

[0025] Optionally, each annular band has a normal state of bearing physiological stress after being implanted into the body and a diameter-expanded state of expanding under a stress greater than the physiological stress. The deformation section of the second annular band inclines towards the blood flow channel side in the diameter-expanded state relative to the normal state.

[0026] Optionally, the surgical artificial heart valve further includes a metal frame around the blood flow channel. The edges of each valve leaf include a fixed edge and a movable edge that enclose each other. The fixed edge is connected to the metal frame, and the movable edge is located in the blood flow channel. The movable edges of two adjacent valve leaves are joined together.

[0027] Optionally, a suture ring is fixed on the inflow side of the support structure, and the annular bands and the suture ring are integrally coated with a first wrapping layer.

[0028] Optionally, the metal frame is integrally coated with a second wrapping layer.

[0029] Optionally, the metal frame is docked on the outflow side of the first annular band.

[0030] Optionally, the shape of the metal frame is adapted to the shape of the outflow side edge of the first annular band.

[0031] Optionally, the extension strip has a threading hole.

[0032] Optionally, in the overall shape of the annular band, in the first annular band, the outflow side edge of the connection part between two adjacent extension strips is a smooth curve.

[0033] Optionally, the outflow side edge of the corresponding part in the second annular band is a smooth curve.

[0034] Optionally, the two annular bands are made of metal or plastic, and at least one of the two annular bands is made of metal.

[0035] Optionally, the strength of the second annular band is higher than that of the first annular band.

[0036] Optionally, the material of the first annular band is plastic, and the material of the second annular band is metal.

[0037] Optionally, the material of the first annular belt is one or more of ABS plastic, acrylic resin, polyvinyl chloride, polycarbonate, polypropylene, polyethylene, polyoxymethylene, polyamide, fluorinated ethylene propylene, polyetherimide, polyether ether ketone, polytetrafluoroethylene, polyester, and polysulfone.

[0038] Optionally, the material of the second annular belt is one or more of stainless steel, titanium alloy, cobalt-based alloy, and nickel-titanium alloy.

[0039] Optionally, each annular belt is independently an integral ring or formed by strip-shaped members, and the two ends of the strip-shaped members are overlapped and welded and fixed to each other.

[0040] Optionally, the detour structure is at least open toward the inflow side.

[0041] Optionally, the detour structure is only open toward the inflow side.

[0042] Optionally, in the normal state without diameter expansion, the extension path of the detour structure turns at least 120 degrees.

[0043] Optionally, in the normal state without diameter expansion, the extension path of the detour structure turns at least 180 degrees.

[0044] Optionally, the area surrounded by the detour structure is an open area, and along the axial direction of the support structure, the open area of the first annular belt is longer than that of the second annular belt.

[0045] Optionally, along the axial direction of the support structure, the ratio of the length L1 of the open area of the first annular belt to the length L2 of the open area of the second annular belt in the normal state is 1.1 to 3.

[0046] Optionally, the ratio of L1:L2 is 1.1 to 2.

[0047] Optionally, the number of deformation segments on each annular belt is the same, which is 2 to 6.

[0048] Optionally, the structures of the deformation segments on the same annular belt are the same.

[0049] Optionally, the deformation segments are evenly spaced on the corresponding annular belt.

[0050] Optionally, the number of deformation segments on the second annular belt is an integer multiple (such as 1 to 3 times) of the number of deformation segments on the first annular belt.

[0051] Optionally, along the circumferential direction of the support structure, the detour structure includes one or a plurality of continuously arranged unit areas, the shapes of the unit areas are the same or different, and the shapes of the unit areas are independently configured as Ω-shaped, N-shaped, W-shaped, M-shaped or V-shaped.

[0052] Optionally, in the axial direction of the support structure, each unit area adopts an asymmetric structure.

[0053] Optionally, in the circumferential direction of the annular belt, multiple unit areas are symmetrically arranged.

[0054] Optionally, the first annular belt has a narrow release deformation opening on the inflow side of the extension strip, and the peripheral part of the release deformation opening is the meandering structure.

[0055] Optionally, the release deformation opening extends with a constant width.

[0056] Optionally, the ratio of the length to the width of the release deformation opening is 5:1 to 100:1.

[0057] Optionally, the ratio of the length to the width of the release deformation opening is 10:1 to 80:1.

[0058] Optionally, the release deformation opening extends along the axial direction of the extension strip.

[0059] Optionally, part or all of the meandering structure on the second annular belt is in a Ω shape, with two opposite outward-turned ends on the outflow side, and the outflow side is the curved top.

[0060] Optionally, the number of deformation segments on each annular belt is the same as the number of valve leaflets.

[0061] Optionally, the number of deformation segments on each annular belt is the same as the number of extension strips and they are in corresponding positions.

[0062] Optionally, the angle of each deformation segment relative to the axis of the support structure is the central angle of each deformation segment, and the range of the central angle of each deformation segment is 5 degrees to 30 degrees.

[0063] Optionally, the sum of the central angles of each deformation segment on a single annular segment is less than or equal to 100 degrees.

[0064] Optionally, each deformation segment is a single-layer structure in the radial direction.

[0065] Optionally, the pulling members are distributed at the positions of the deformation segments on the two annular belts.

[0066] Optionally, the pulling members are only distributed at the positions of the deformation segments on the two annular belts.

[0067] Optionally, the pulling members are rigid members, and are grouped in pairs, with a group of pulling members arranged on both circumferential sides of each deformation segment.

[0068] Optionally, the pulling members are flexible members and bind and fix the two annular belts.

[0069] Optionally, at least one annular belt is provided with connection holes for the pulling members to pass through.

[0070] Optionally, the connecting holes are respectively formed on both sides of the release deformation opening on the first annular belt.

[0071] Optionally, on both circumferential sides of the deformation section on the second annular belt, there are support pieces extending towards the outflow side.

[0072] Optionally, the inflow side of the extension strip of the first annular belt is a triangular area, and in the normal state, the deformation section on the second annular belt together with the support pieces on both sides abuts against the triangular area.

[0073] Optionally, along the axial direction of the support structure, the deformation section on the second annular belt is higher than the support pieces on both sides of the deformation section.

[0074] Optionally, there is a long and narrow opening opening towards the outflow side between the deformation section on the second annular belt and the support pieces on both sides thereof.

[0075] Optionally, the inflow side of the long and narrow opening is closed, and the inner edge of the closed part is arc-shaped.

[0076] Optionally, the deformation section of at least one of the first annular belt or the second annular belt allows it to expand, and at the same time defines a maximum expansion diameter for at least one of the first annular belt or the second annular belt.

[0077] Optionally, the deformation section of at least one of the first annular belt or the second annular belt undergoes three-dimensional twisting when it expands.

[0078] The present invention realizes the diameter expansion of the annular belt through the deformation section, and also plays a role in defining the maximum expansion diameter, thereby overcoming the postoperative variation problem of the valve-in-valve surgery and effectively improving the treatment effect.

[0079] The specific beneficial technical effects will be further explained in combination with the specific structure or steps in the specific implementation manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0080] Figure 1a It is a schematic diagram of a surgical artificial heart valve in an embodiment of the present invention;

[0081] Figure 1b is Figure 1a an enlarged cross-sectional schematic diagram of a structure at the position indicated by the letter C in;

[0082] Figure 1c is Figure 1a an enlarged cross-sectional schematic diagram of another structure at the position indicated by the letter C in;

[0083] Figure 2 It is an exploded schematic diagram of an embodiment that can be used together with the support structure of the heart valve in FIG. 1;

[0084] Figure 3a is forFigure 1a Schematic diagram of an embodiment for use with the second annular band of a heart valve;

[0085] Figure 3b For Figure 3a Enlarged schematic diagram of the deformed section of the second annular band in [[ ]];

[0086] Figure 3c For Figure 3a Schematic diagram of the angle annotation of the deformed section of the second annular band in [[ ]];

[0087] Figure 3d For Figure 3a Schematic diagram of the diameter-expanded state of the deformed section of the second annular band in [[ ]];

[0088] Figure 3e For Figure 3d Another perspective schematic diagram of the deformed section in the diameter-expanded state in [[ ]];

[0089] Figure 3f For Figure 3b In [[ ]], the deformed section in the diameter-expanded state cooperating with Figure 1a The heart valve;

[0090] Figure 3g Schematic diagram of another embodiment of the second annular band;

[0091] Figure 3h Schematic diagram of an alternative embodiment of the deformed section including multiple unit areas;

[0092] Figure 3i For Figure 3d Top-down perspective schematic diagram of the deformed section in the diameter-expanded state in [[ ]];

[0093] Figure 4a For Figure 2 Schematic diagram in an embodiment of the first annular band of the support structure in [[ ]];

[0094] Figure 4b For Figure 4a Enlarged schematic diagram of the release deformation opening part of the first annular band in [[ ]];

[0095] Figure 4c For Figure 4a Schematic diagram of the diameter-expanded state of the release deformation opening of the first annular band in [[ ]];

[0096] Figure 4d Schematic diagram of another embodiment of the first annular band;

[0097] Figure 5a For Figure 2 Assembly schematic diagram of the support structure in [[ ]];

[0098] Figure 5b For use withFigure 2 and Figure 5a Schematic diagram of an embodiment of a metal frame used together with the support structure in

[0099] Figure 5c is Figure 2 and Figure 5a the support frame in Figure 5b exploded schematic diagram of the metal frame of

[0100] Figure 5d Schematic diagram of the assembly of a surgical artificial heart valve in another embodiment;

[0101] Figure 5e is Figure 5d schematic diagram of the pulling member during the diameter expansion process in the embodiment of

[0102] Figure 5f Schematic diagram of the assembly of a surgical artificial heart valve in another embodiment;

[0103] Figure 6 Schematic diagram of the relationship between the internal pressure of the inflation device and the inflation of the deformation section in one embodiment;

[0104] Figure 7 Schematically shows the surgical artificial heart valve of the present invention deployed in the cardiac annulus;

[0105] Figure 8 Schematically shows the subsequent deployment of the Figure 7 interventional valve in the surgical artificial heart valve shown in

[0106] Figure 9 is Figure 3a enlarged view of different embodiments of the deformation section of the second annular band in

[0107] Explanation of the reference numerals in the figure is as follows:

[0108] 1. Blood flow channel; 11. Inflow side; 12. Outflow side; 2. Support structure; 21. First annular band; 211. Extension strip; 2111. Triangular area; 212. Release deformation opening; 213. Threading hole; 22. Second annular band; 221. Deformation section; 2211. First side; 2212. Second side; 2213. Everted end; 2214. Curved top; 222. Support piece; 223. Narrow opening; 23. Connecting hole; 24. Pulling member; 25. Suture ring; 26. First wrapping layer; 261. Tightening area; 3. Valve leaflet; 31. Fixed edge; 32. Movable edge; 4. Metal frame; 41. Second wrapping layer; 5. Interventional valve; 27. Unit area. Detailed implementation mode

[0109] In conjunction with the accompanying drawings in the embodiments of the present application, the technical solutions in the embodiments of the present application will be described. The described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments.

[0110] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0111] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which this application belongs. The terms used in the description of this application in this specification are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0112] The present invention describes embodiments of a surgical artificial heart valve and modifications that can be made thereto. The surgical heart valve of the present invention is mainly suitable for use in a valve-in-valve deployment to receive a subsequent THV, although the principles of the present invention can also be applied to other surgical artificial heart valves.

[0113] Refer to the attached Figure 1a To FIGS. 5, an embodiment of the present invention discloses a surgical artificial heart valve, including a support structure 2 and a plurality of leaflets 3. The support structure 2 is generally annular, and the inside of the annulus is a blood flow channel 1. The support structure 2 has an inlet side 11 and an outlet side 12 opposite to each other along the annular axis. The plurality of leaflets 3 are connected to the support structure 2 to control the blood flow through the blood flow channel 1. The support structure 2 includes:

[0114] A first annular band 21, on which a plurality of extension strips 211 extending towards the outlet side 12 and circumferentially spaced apart are provided, and the joint of adjacent leaflets 3 matches the corresponding extension strip 211;

[0115] A second annular band 22, which is fixedly attached to the inner or outer side of the first annular band 21 and is adjacent to the inlet side 11 of the first annular band 21.

[0116] In the first annular band 21 and the second annular band 22, each annular band is circumferentially spaced with a deformation section 221 that allows the annular band to expand in diameter.

[0117] By means of the deformation section 221, the annular band expands in diameter. During the process of performing a valve-in-valve operation, it is possible to pass through the interventional valve 5 (for example Figure 3fThe self-expanding property of the THV shown or a separate expansion device is used to expand the diameter of the surgical artificial heart valve. The surgical artificial heart valve in this application can achieve linear and predictable diameter expansion under a relatively low pressure (compared with the prior art). At the same time, after the deformation section 221 is fully expanded (or undergoes complete deformation), it can also limit the diameter expansion trend, thereby providing the ability to restrain the interventional valve.

[0118] Reference Figure 2 and 5c , the circumferential positions of the deformation sections 221 of the two annular bands 21 and 22 are aligned with each other. The mutually aligned deformation sections 221 can synchronously release the diameter expansion stroke, providing a controllable and linear diameter expansion process. At the same time, during the diameter expansion process, the possibly displaced parts of the support structure 2 are aligned with each other, which is convenient for the installation and connection of other components.

[0119] Regarding the understanding of synchronously releasing the diameter expansion stroke, it can be considered from two perspectives: circumferential position and radial position.

[0120] In terms of the circumferential position, other components are often wrapped or installed on the support structure 2. The mutually aligned deformation sections 221 can avoid unnecessary or unintended position-related deformation of each component in the circumferential direction (such as the wrapping layer, suture ring, etc.). In particular, this avoids the non-synchronous deformation process where one component deforms while the other does not during the deformation process.

[0121] In terms of the radial position, during the deformation process, the deformation section 221 shows a change in its own length in the circumferential direction of the annular band, and this length change will cause a change in the overall circumference of the annular band, thereby causing a change in the radial position of each deformation section. In this embodiment, the mutually aligned deformation sections 221 can synchronize their radial positions with each other. At the same time, as a frame structure in three-dimensional space, the support structure 2 will directly cause a three-dimensional torsion of the components in space due to the change in the circumference of the annular band. Specifically, on the deformation section 221, it is manifested as a warping trend compared to the circumferential surface of the annular band. The deformation sections 221 with synchronized positions can superimpose their warping trends on each other, so as to better achieve the clamping of the THV introduced later.

[0122] Specifically, in terms of the understanding of alignment, in a reference embodiment, each deformation section has a circumferential central position on the corresponding annular band, and the central positions of the deformation sections on the two annular bands are aligned with each other. Specifically, on the first annular band 21, there is a narrow release deformation opening on the inflow side 11 of the extension strip 211, and the release deformation opening serves as the deformation section of the first annular band 21; the deformation section of the second annular band 22 has a plurality of curved structures (hereinafter referred to as "detour structures") and forms an opening opening towards the inflow side 11; among them, the release deformation opening is aligned with the opening.

[0123] The outflow side 12 edges of the first annular band 21 and the second annular band 22 are roughly aligned. In order to match the characteristics of the surrounding tissue structure, the edges of the first annular band 21 and the second annular band 22 are not flat circles, but three arcs are combined into a three-dimensional structure.

[0124] In addition, the circumferential positions of the deformation segments 221 on the first annular belt 21 correspond to the extension strips 211 one by one.

[0125] Since the joints of adjacent leaflets 3 match the corresponding extension strips 211, when each annular band expands and deforms, the circumferential position of the deformation portion is mainly concentrated at the joints of adjacent leaflets 3, and the pulling force on each leaflet itself is relatively small, thereby avoiding the risk of leaflet tearing or even partial detachment.

[0126] The support structure 2 serves as a frame structure in three-dimensional space, in which changes in the circumference of the annular belt will directly lead to three-dimensional torsion of the component in space. When the first annular belt 21 is located on the inflow side of the extension strip 211, changes in the length of the first annular belt 21 will directly lead to a tendency for the extension strip 211 to move closer to each other on the outflow side, that is, an inward tilting tendency of the extension strip 211. The one-to-one correspondence between the circumferential position of the deformation segment 221 and the extension strip 211 can synchronize the movement of the two annular belts on the inward tilting tendency of the extension strip 211, thereby ensuring the fit between the two in the expanded diameter state. Furthermore, the superposition of the inward turning tendency of the two annular belts can also be achieved.

[0127] Each annular band has a normal state of bearing physiological stress after implantation and an expanded state of expanding under stress greater than the physiological stress. The deformation section 221 of the second annular band 22 is inclined toward the blood flow channel 1 side in the expanded state relative to the normal state.

[0128] The focus of this embodiment is that the deformation segment 221 will produce distortion outside its own plane (ie, three-dimensional distortion) during the diameter expansion process. This distortion occurs during the expansion of the second annular band 22, such as during valve-in-valve surgery. Figure 3i and Figure 3e The out-of-plane twisting of the deformable segment 221 is well shown, and the out-of-plane twisting of the deformable segment 221 will add additional holding force to the intervention valve 5. Figure 3e , the deformed section 221 is twisted inwardly so that its bent top 2214 is slightly inwardly.

[0129] Compared with the prior art, the twisting of the deformation segment 221 in this embodiment increases the positioning capability of the surgical valve on the subsequent interventional valve 5, thereby increasing further safety for the valve-in-valve surgery.

[0130] Reference Figure 5b To Attachment Figure 5f The surgical artificial heart valve also includes a metal frame 4 around the blood flow channel 1, and at the same time, reference Figure 1a, the edges of each leaflet 3 include a fixed edge 31 and a movable edge 32 that enclose each other, where the fixed edge 31 is connected to the metal frame 4, the movable edge 32 is located within the blood flow channel 1, and the movable edges 32 of two adjacent leaflets 3 are joined together.

[0131] The fixed edge 31 can be cooperated with the metal frame 4 by means of fixed connection methods such as sewing and bonding;

[0132] It can also be cooperated with the metal frame 4 by means of non-fixed connection methods, where the non-fixed connection methods are, for example, crimping, snapping, biting, friction, etc.;

[0133] It can also be cooperated with the metal frame 4 by other components. Refer to Appendix Figure 1b and Appendix Figure 1c . The metal frame 4 is integrally covered by a second wrapping layer 41, where the second wrapping layer 41 is connected to the leaflet 3 and wraps the metal frame 4 to realize the connection between the fixed edge 31 and the metal frame 4. Similarly, between the second wrapping layer 41 and the metal frame 4, the above-mentioned fixed connection method or non-fixed connection method can also be used for installation.

[0134] A suture ring 25 is fixed to the inflow side 11 of the support structure 2, and each annular band and the suture ring 25 are integrally covered by a first wrapping layer 26. The suture ring 25 can be located on the outer periphery of the inflow side 11 of the support structure 2, or at the end face part of the inflow side 11.

[0135] Refer to Appendix Figure 1b shown, the suture ring 25 is arranged on the outer side in the radial direction of the support structure 2; it can also refer to Appendix Figure 1c , the suture ring 25 is arranged on the axial inflow side of the support structure 2. The suture ring 25 can be a separate component and is detachably installed on the inflow side 11 of the support structure 2. For the specific installation method, refer to the above-mentioned fixed connection method or non-fixed connection method. The first wrapping layer 26 tightens each annular band and the suture ring 25, thereby improving the integrity. In terms of the installation method, the material can be tightened by the wrapping force of the first wrapping layer 26 itself, and it can also be tightened further by binding in the tightening area 261 shown in Appendix Figure 1c . At the same time, the binding in the tightening area 261 can also provide an independent constraint space for the suture ring 25, further improving the positioning effect.

[0136] The suture ring 25 can be made of elastic materials such as silicone, or porous materials such as felt, etc., mainly used for the suture positioning of the surgical valve and the surrounding tissues in the body, and can also assist in preventing periprosthetic leakage. The overall cross-section is circular, oval, rectangular, etc. In this embodiment, there is no strict requirement for the internal and external settings of the first annular band 21 and the second annular band 22, so the internal and external relationships between the two can be adjusted with each other.

[0137] In the mating relationship of the components, the metal frame 4 is butted against the outflow side 12 of the first annular belt 21. The specific butting form can be connection methods such as welding and fastener connection, or it can also be clamped with the first annular belt 21 through its own shape. The shape of the metal frame 4 is adapted to the edge shape of the outflow side 12 of the first annular belt 21. That is, the contour of the metal frame 4 fits the contour of the outflow side 12 of the first annular belt 21.

[0138] Reference Figure 4a - 4c , the components are connected by strip-shaped restraint members. There are threading holes 213 on the extension strip 211. The restraint members can pass through each threading hole 213 to pierce and bind the components. The restraint members can specifically be fibers with good biocompatibility and / or plastic ropes.

[0139] In the overall shape of the annular belt, in the first annular belt 21, the outflow side edge of the connecting part between two adjacent extension strips is a smooth curve. Similarly, the outflow side edge of the corresponding part in the second annular belt 22 is a smooth curve.

[0140] In the selection of the materials of the components, the indicators such as strength, weather resistance, and biocompatibility should be met. In one embodiment, the materials of the two annular belts are each metal or plastic, and at least one of them is metal.

[0141] The difference in materials is mainly manifested in the strength difference between the two. In one embodiment, the strength of the second annular belt 22 is higher than that of the first annular belt 21. The strength here is mainly manifested as the radial anti-deformation ability for the support structure 2, which can be understood as the radial stiffness. In the process of driving the deformation section 221 to deform by the corresponding component, the strength mentioned above is mainly overcome. Through the setting of materials, the above requirements can be conveniently achieved. Specifically, in one embodiment, the material of the first annular belt 21 is plastic, and the material of the second annular belt 22 is metal. In a specific product, the material of the first annular belt 21 is one or more of ABS plastic, acrylic resin, polyvinyl chloride, polycarbonate, polypropylene, polyethylene, polyoxymethylene, polyamide, fluorinated ethylene propylene, polyetherimide, polyether ether ketone, polytetrafluoroethylene, polyester, and polysulfone. Similarly, the material of the second annular belt 22 is one or more of stainless steel, titanium alloy, cobalt-based alloy, and nickel-titanium alloy.

[0142] In the specific production method, referring to the embodiments shown in Att Figure 3g and Att Figure 4d Each annular belt independently adopts an integral ring. The specific production process can be obtained by removing materials from a tubular blank or by powder metallurgy integral molding. Or referring to Att Figure 3a and Att Figure 4aIn the embodiment shown, each annular band is surrounded by a strip, and the two ends of the strip are overlapped and fixed by welding. The plastic part can be obtained by injection molding, blow molding or 3D printing or by strips whose ends are bonded by adhesives or other bonding methods.

[0143] In order to provide the deformation section 221, a weak structure may be provided. Figure 3b and attached Figure 4b In the illustrated embodiment, in the first annular belt 21 and the second annular belt 22, a portion of each annular belt has an open winding structure, and the winding structure allows the annular belt to expand in diameter.

[0144] For detailed settings, refer to the attached Figure 3a and attached Figure 5a In the disclosed embodiment, the meandering structure is open toward the inflow side 11. Referring to the deformation section 221 of the second annular band 22 (see Figure 3c and 3d ), the circuitous structure is defined as Figure 3c and 3d The left side begins at the outwardly turned end 2213, then bends at an obtuse angle A toward the generally straight segment shown by the first side 2211, then to the bulbous or curved tip 2214, which makes a 180-degree turn toward the generally straight segment shown by the second side 2212 opposite the first side 2211, and finally bends at an obtuse angle to Figure 3c and 3d The other outward end 2213 on the right side. Therefore, the circuitous structure is similar to an Ω shape. Therefore, the space between the two straight segments 2211 and 2212 defines an open area or an open space. Angle A substantially affects the opening tendency of the circuitous structure. In a specific product, in a normal state without expansion, angle A is at least 180 degrees. The specific shape of the circuitous structure is also affected by the shape of its circuitous extension path corresponding to its inscribed circle. Figure 3c The central angle B is shown. Figure 3c In the embodiment shown, the angle of the central angle B is greater than or equal to 260 degrees. In actual products, the corresponding angle of the central angle B is greater than or equal to 300 degrees.

[0145] See attached Figure 3a To Attachment Figure 3g In the illustrated embodiment, the meandering structure is provided with a unit area for deformation. As used herein, the term "unit area" refers to an Ω-shaped structure. Figure 3h In the optional embodiment shown, along the circumference of the support structure 2, the meandering structure includes a plurality of unit areas 27 arranged continuously, wherein each unit area has the same shape. Figure 3hAs shown, the meandering structure includes two unit areas, and each unit area has an Ω-shaped structure. In other embodiments, each unit area may have a different shape. Each unit area may also be independently configured as an N-shape, a W-shape, an M-shape, or a V-shape, or any other shape that allows compression and expansion in the manner shown in Figure 3c and Figure 3d . The unit areas may also partially overlap. In terms of the arrangement form of each unit area, with respect to each unit area, in the axial direction of the support structure 2, each unit area adopts an asymmetric structure. In terms of the deformation section 221, in the circumferential direction of the annular belt 22, a plurality of unit areas are symmetrically arranged.

[0146] The meandering structure of the deformation section 221 can be reversed. For example, Figure 9 shows a different embodiment in which a single Ω structure has been reversed.

[0147] Each deformation section in the first annular belt 21 is best shown in Figure 4b and 4c , and has a narrow and long release deformation opening 212 on the inflow side 11 of the extension strip 211. The peripheral part of the release deformation opening 212 is a meandering structure. The meandering structure in the expanded state of the release deformation opening 212 is best shown in Figure 4c , and is generally V-shaped, with a curved top opening at the vertex of the V-shape. When the first annular belt 21 is in a compressed state (see Figure 4b ), the release deformation opening 212 is similar to a slit, and the curved top opening is almost circular. The release deformation opening 212 extends along the axial direction of the extension strip 211. The axial direction of the support structure 2 and the axial direction of the extension strip 211 are arranged parallel to each other. The narrowness of the release deformation opening 212 is specifically manifested as its equal-width extension on the support structure 2. Further, referring to the appendix Figure 4b , the ratio of the length to the width of the release deformation opening 212 is 5:1 to 100:1. In a preferred embodiment, the specific ratio of the length to the width of the release deformation opening 212 is 10:1 to 80:1. More preferably, the specific ratio of the length to the width of each release deformation opening 212 is 20:1 to 60:1.

[0148] The above two different meandering structures for the two annular belts 21 and 22 are only exemplary. In fact, either of the two different meandering structures can be independently provided on either of the two annular belts 21 and 22. In some embodiments, the meandering structures of the two annular belts 21 and 22 may adopt the same structure, while in other embodiments, the meandering structures of the two annular belts 21 and 22 may also adopt different structures. Regardless of the meandering structure adopted by the two annular belts 21 and 22, the detailed structures shown and described herein for the meandering configurations of the two annular belts 21 and 22 can be modified or adjusted. For example, the appendix Figure 2In the illustrated embodiment, the area surrounded by the detour structure is an open area. Along the axial direction of the support structure 2, the open area of the first annular band 21 is longer than that of the second annular band 22. "Longer" herein means that in the extending direction from the inflow side 11 to the outflow side 12, the open area of the first annular band 21 is longer than that of the second annular band 22. In the case of the same form of the detour structure, a longer open area means a longer deformation stroke. The deformation stroke is mainly manifested as the dimensional change in the circumferential direction of the first annular band 21 or the second annular band 22. That is, the detour structure with a longer open area can increase the circumferential dimension of the annular band where it is located to a greater extent after deformation. Similarly, the deformation stroke of different detour structures can also be matched by setting the length of the open area.

[0149] The setting of the dimensional difference between the open area of the first annular band 21 and that of the second annular band 22 can also synchronize the radial positions of the two in the expanded diameter state. On the surrounding components, the inflow side 11 of the extension strip 211 of the first annular band 21 is a triangular area 2111. Under normal conditions, the deformation section 221 on the second annular band 22 and the supporting pieces 222 on both sides are attached to the inner side of the triangular area 2111. During the deformation process of the release deformation opening 212, the triangular area 2111 will show a tendency to flip relative to the circumferential direction of the annular band 21, and this flipping tendency may cause a certain gap between the two annular bands 21 and 22 in the expanded diameter state. Through geometric analysis, it can be known that when the length of the release deformation opening 212 along the axial direction of the support structure 2 is longer, the flipping tendency of the triangular area 2111 can be evenly distributed over a longer distance, thereby reducing the overall flipping tendency and synchronizing the deformation of the two annular bands 21 and 22 to keep the two annular bands in contact. Refer to the Figure 2 annotation in the attached drawings. Along the axial direction of the support structure 2, the ratio of the length L1 of the open area of the first annular band 21 to the length L2 of the open area of the second annular band 22 in the normal state is 1.1 to 3. In a preferred embodiment, the ratio of L1:L2 is 1.1 to 2. In the embodiment shown in the attached drawings, the specific ratio of L1:L2 is 1.15 to 1.35.

[0150] The number of deformation sections of the two annular bands can be set to be equal for convenient alignment one by one. Or, the number of deformation sections 221 on the second annular band 22 is an integer multiple of the number of deformation sections 221 on the first annular band 21. Depending on different application products, the integer multiple mentioned above can be selected as 1 time, 2 times or 3 times.

[0151] In terms of the quantity setting, more deformation segments 221 can bring a larger deformation space, but at the same time, it will also cause a decrease in the strength of the support structure 2. In reference to an embodiment, the number of deformation segments on each annular band 21 and 22 is the same, which is 2 to 6. In the embodiment shown in the attached drawings, it is shown that there are 3 deformation segments 221 provided on each annular band. An increase in the number of deformation segments 221 will also bring difficulties in maintaining the consistency of each deformation segment 221. A low consistency of the deformation segments 221 will cause the deformation of each deformation segment 221 to be out of sync during the deformation process, resulting in a decrease in the degree of linear change during the overall deformation process of the support structure 2. In this embodiment, the structures of the deformation segments 221 are the same. Similarly, the deformation segments 221 are evenly spaced on the corresponding annular bands. The even spacing arrangement can avoid the influence of other components on the deformation of the deformation segments 221.

[0152] The number of deformation segments is the same as the number of valve leaflets. In one embodiment, the number of deformation segments is the same as the number of extension strips 211 and the positions correspond. Refer to the attached Figure 3f , the angle of each deformation segment with respect to the axis of the support structure 2 is the central angle B of each deformation segment, and the range of the central angles between the deformation segments is 5 degrees to 30 degrees. The sum of the central angles of the deformation segments on a single annular segment is less than or equal to 100 degrees. It is not difficult to understand from the above description that the deformation segments mentioned in this embodiment are single-layer structures in the radial direction. Each deformation segment relies on its own deformation and there are no additional guiding or limiting components. During the deformation process, each deformation segment adopts a non-breaking circumferential method.

[0153] Refer to Figure 5d , in another embodiment of the present invention, the first annular band 21 and the second annular band 22 are the same as those in Figure 2 , except that the two annular bands 21 and 22 are connected by a pulling member 24, and the connection part of the pulling member 24 is adjacent to the deformation segment 221 of each annular band.

[0154] The pulling member 24 is synchronized with the deformation part and the amount of deformation of the first annular band 21 and the second annular band 22 to avoid unexpected misalignment after deformation.

[0155] In addition to the wrapping layer, the first annular band 21 and the second annular band 22 can also be connected by a pulling member 24. Refer to the attached Figure 5e and the attached Figure 5f In the embodiment, between the first annular band 21 and the second annular band 22, there is a pulling member 24 connecting the two annular bands. The distribution of the pulling member 24 can adjust the working effect of the pulling member 24 on the annular band. For example, in the attached Figure 5d and 5eIn the illustrated embodiment, the pulling member 24 is distributed adjacent to the deformed segments 221 of each annular band and is used for synchronizing the deformation processes of the deformed segments 221 of each annular band. In other embodiments, the pulling member 24 can also be arranged at other positions on the first annular band 21 and the second annular band 22, such as non-deformed segment parts. In addition to synchronizing the deformation of the deformed segments 221 of each annular band, the pulling member 24 can also limit the independent movement of each annular band 21 and 22, so that the pulling member 24 is preferably only distributed at the deformed segments 221 of the annular band to avoid excessive restraint from the pulling member 24.

[0156] In one embodiment, the pulling member 24 is a rigid member and is made of materials such as plastics, metals or alloys.

[0157] Alternatively, in another embodiment, the pulling member 24 is a flexible member and binds and fixes the two annular bands. The pulling member 24 is made of materials such as fibers and / or cords made of natural or synthetic materials, for example.

[0158] To ensure the pulling effect, the pulling members 24 can be grouped in pairs, and a corresponding pair of pulling members 24 are arranged on both circumferential sides of each deformed segment 221.

[0159] The annular band needs to provide an installation position for the pulling member 24 to improve the installation effect. In one embodiment, at least one annular band 21 is provided with connection holes 23 through which the pulling member 24 can pass. The connection holes 23 can provide restraint for the pulling member 24. Structurally, the connection holes 23 can be through holes that are circumferentially closed and axially penetrate the annular band 21 or restraint holes that are circumferentially open and axially penetrate the annular band 21; the connection holes 23 can also be set as blind holes that are circumferentially closed and axially closed or restraint holes that are circumferentially open and axially closed. The specific shape of the connection holes 23 can be flexibly set according to different pulling members 24 and different fixing parameter requirements selected for a given application product. The inner edges of the connection holes 23 preferably adopt smooth curves, such as round holes or oval holes.

[0160] The design advantage of the pulling member 24 is that it can achieve the consistent and uniform expansion of the support frame of the surgical valve under the action of external forces through its connection strength. This characteristic can achieve uniform, symmetric and predictable expansion during the valve-in-valve surgery.

[0161] In the layout of the connection holes 23, they can be arranged at multiple locations on the annular band 21. Or, connection holes 23 are respectively opened on both sides of the release deformation opening 212 on the first annular band 21. Similarly, connection holes 23 can also be provided at corresponding positions on the second annular band 22. Further, the connection holes 23 on the first annular band 21 are aligned with the connection holes 23 on the second annular band 22.

[0162] In this embodiment, there is no strict requirement for the inner and outer settings of the first annular band 21 and the second annular band 22. Therefore, the inner and outer relationships between the two can be adjusted with each other. Figure 5f In the embodiments of Figure 5d The same principles shown and described in can be set with reference to the attached drawings, which will not be elaborated here.

[0163] Refer to the attached drawings Figure 3b , on both circumferential sides of the deformation section 221 on the second annular band 22, there are support pieces 222 extending towards the outflow side 12. The support pieces 222 can further control the deformation process of the deformation section 221. Along the axial direction of the support structure 2, the deformation section 221 on the second annular band 22 extends to a position higher than the highest points of the support pieces 222 on both sides. In terms of the cooperation details between the deformation section 221 and the support pieces 222, there is a narrow opening 223 opening towards the outflow side 12 between the deformation section 221 on the second annular band 22 and the support pieces 222 on both sides. The inflow side 11 of the narrow opening 223 is closed, and the inner edge of the closed part is arc-shaped. The narrow opening 223 becomes narrower as it extends towards the outflow side 12. The narrow opening 223 can allow relative movement between the deformation section 221 and the support pieces 222, and at the same time can also provide a structural basis for other functions. For example, in one embodiment, the narrow opening 223 is a connection hole 23 for connecting the pulling member 24. The pulling member 24 is used to connect the first annular band 21 and the second annular band 22.

[0164] In addition to cooperating with the deformation section 221 of the second annular band 22, the support piece 222 can also cooperate with the first annular band 21. For example, the inflow side 11 of the extension strip 211 of the first annular band 21 is approximately a triangular area 2111. Refer to Figure 4b , under normal conditions, the deformation section 221 on the second annular band 22 together with the support pieces 222 on both sides abuts against the triangular area 2111.

[0165] In this application, through the setting of the deformation section 221, the surgical valve can be controlled, evenly and symmetrically expanded under the required working conditions. The design of the length, shape and material properties of the deformation section 221 should ensure that: when a balloon or other mechanism applies sufficient radial force to the surgical valve, the deformation section 221 allows the first annular band 21 and the second annular band 22 to expand. The deformation section 221 has a normal state and gradually deforms as the circumferences of the first annular band 21 and the second annular band 22 increase. As Figure 3d shown, the deformation of the deformation section 221 is manifested as gradually straightening. When the deformation stroke of the deformation section 221 is released and expanded, the deformation section 221 locks the circumferences of the first annular band 21 and the second annular band 22 to prevent further expansion. Here, the deformation section 221 defines the maximum expansion diameter, which is the limit of expansion.

[0166] When a balloon or other mechanism applies a radial force to a surgical heart valve, the method used is pressure inflation. Therefore, the relationship between pressure and the expansion of the deformation section 221 can be obtained by referring to the Figure 6 chart shown in the attached figure. In the attached figure, the abscissa is the radial expansion pressure provided by the delivery system, with the unit of one standard atmosphere (atm), and the ordinate is the expansion of the deformation section 221, with the unit of millimeter (mm). Among them:

[0167] In the initial stage, under a pressure of 0 atmospheres, the surgical valve has already expanded slightly. This slight expansion is caused by the radial force generated by the self-expanding characteristics of the interventional device deployed within the annulus.

[0168] In the expansion stage, under the condition of applying balloon pressure, the deformation section 221 deforms to expand the annulus.

[0169] In the end stage, after the pressure reaches 3 atmospheres, at this time the deformation section 221 has been fully expanded, and at this time the deformation section 221 begins to resist further expansion. Specifically, it is manifested as: when the pressure increases from 3 atmospheres to 4 atmospheres, the expansion change amplitude of the deformation section 221 is significantly smaller than that in the expansion stage.

[0170] Figure 7 Shows the support structure 2 of the surgical heart valve according to Figure 1a - 5c deployed at the aortic valve annulus of the human heart. When this surgical heart valve is defective and a THV 5 is required, a new THV 5 can be delivered in a minimally invasive manner and fixed within the support structure 2. This is shown in Figure 8 . The present invention provides a method for expanding the diameter of a surgical heart valve without disconnecting any components of the original surgical heart valve. When pressure is applied using a balloon or other mechanism, the surgical heart valve will expand in a predictable and linear manner, facilitating the doctor performing the subsequent valve-in-valve surgery to stably expand the surgical heart valve. This is much safer than the prior art method of hydraulically fracturing an implanted surgical heart valve, avoiding sudden and uncontrolled expansion of the surgical heart valve under very high pressure.

[0171] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as within the scope described in this specification. When the technical features in different embodiments are shown in the same attached figure, it can be regarded that the attached figure also discloses the combination examples of the various embodiments involved.

[0172] The above-described embodiments merely represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation to the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all fall within the protection scope of the present application.

Claims

1. A surgical artificial heart valve, comprising a support structure and a plurality of valve leaflets. The support structure is generally annular, with a blood flow channel inside the annulus. The support structure has an inlet side and an outlet side along the annular axis, and the plurality of valve leaflets are connected to the support structure. Characterized in that: Wherein the support structure includes: A first annular band having a plurality of extension strips extending towards the outlet side and arranged at intervals in the circumferential direction, and the joint portions of adjacent valve leaflets match the corresponding extension strips; A second annular band that is fixedly attached to the inner or outer side of the first annular band and is adjacent to the inlet side of the first annular band; Among the first annular band and the second annular band, the strength of the second annular band is higher than that of the first annular band. Each annular band is provided with deformation segments that allow the corresponding annular band to expand in the circumferential direction at intervals. The number of deformation segments on each annular band is the same as the number of extension strips and their positions correspond; each deformation segment has a central position in the circumferential direction on the corresponding annular band, and the central positions of the deformation segments on the two annular bands are aligned with each other; Wherein at least one of the deformation segments of the first annular band or the second annular band undergoes three-dimensional twisting and radial inward twisting during its expansion.

2. The surgical artificial heart valve according to claim 1, Characterized in that: Each deformation segment is a single-layer structure in the radial direction.

3. The surgical artificial heart valve according to claim 1, Characterized in that: A partial area of each annular band has an open meandering structure, and this meandering structure serves as the deformation segment.

4. The surgical artificial heart valve according to claim 3, Characterized in that: The meandering structure is at least open towards the inlet side.

5. The surgical artificial heart valve according to claim 3, Characterized in that: The meandering structure is only open towards the inlet side.

6. The surgical artificial heart valve according to claim 3, Characterized in that: In the normal state without expansion, the extension path of the meandering structure turns at least 120 degrees.

7. The surgical artificial heart valve according to claim 3, Characterized in that: In the normal state without expansion, the extension path of the meandering structure turns at least 180 degrees.

8. The surgical artificial heart valve according to claim 3, Characterized in that: The area surrounded by the meandering structure is an open area. Along the axis of the support structure, the open area of the first annular band is longer than that of the second annular band.

9. The surgical artificial heart valve according to claim 3, Characterized in that: On the first annular band, there is a narrow and long release deformation opening on the inlet side of the extension strip, and the peripheral part of the release deformation opening is the meandering structure.

10. The surgical artificial heart valve according to claim 9, Characterized in that: The release deformation opening extends with a constant width.

11. The surgical artificial heart valve according to claim 9, Characterized in that: The ratio of the length to the width of the release deformation opening is 5:1 to 100:

1.

12. The surgical artificial heart valve according to claim 9, Characterized in that: The ratio of the length to the width of the release deformation opening is 10:1 to 80:

1.

13. The surgical artificial heart valve according to claim 9, It is characterized in that the release deformation mouth extends axially along the extension strip.

14. The surgical artificial heart valve according to claim 1, It is characterized in that each annular band has a local open area, and this open area serves as the deformation section.

15. The surgical artificial heart valve according to claim 14, It is characterized in that in the axial direction of the support structure, the ratio of the length L1 of the open area of the first annular band to the length L2 of the open area of the second annular band in the normal state is 1.1 to 3.

16. The surgical artificial heart valve according to claim 15, It is characterized in that the ratio of L1:L2 is 1.1 to 2.

17. The surgical artificial heart valve according to claim 1, It is characterized in that the number of deformation sections on each annular band is the same, and is 2 to 6.

18. The surgical artificial heart valve according to claim 1, It is characterized in that the structures of the deformation sections on the same annular band are consistent.

19. The surgical artificial heart valve according to claim 1, It is characterized in that the deformation sections are evenly spaced on the corresponding annular bands; the number of deformation sections on the second annular band is an integer multiple of the number of deformation sections on the first annular band.

20. The surgical artificial heart valve according to claim 14, It is characterized in that the open area opens towards the inflow side.

21. The surgical artificial heart valve according to claim 14, It is characterized in that along the circumferential direction of the support structure, each open area includes one or a plurality of unit areas arranged continuously, the shapes of the unit areas are the same or different, and each unit area is independently configured in a Ω shape, N shape, W shape, M shape or V shape.

22. The surgical artificial heart valve according to claim 21, It is characterized in that in the axial direction of the support structure, each unit area adopts an asymmetric structure.

23. The surgical artificial heart valve according to claim 21, It is characterized in that in the circumferential direction of the annular band, a plurality of unit areas are symmetrically arranged.

24. The surgical artificial heart valve according to claim 1, It is characterized in that the angle of each deformation section relative to the axis of the support structure is the central angle of each deformation section, and the central angle range of each deformation section is 5 degrees to 30 degrees.

25. The surgical artificial heart valve according to claim 24, It is characterized in that the sum of the central angles of the deformation sections on a single annular section is less than or equal to 100 degrees.

26. The surgical artificial heart valve according to claim 14, It is characterized in that the first annular band has a narrow release deformation mouth on the inflow side of the extension strip.

27. The surgical artificial heart valve according to claim 14, It is characterized in that the local or whole of the open area on the second annular band is in a Ω shape, with two opposite outward-turning ends on the inflow side and a curved top on the outflow side.

28. The surgical artificial heart valve according to claim 14, It is characterized in that along the axial direction of the support structure, the open area of the first annular band is longer than the open area of the second annular band.

29. The surgical artificial heart valve according to claim 1, It is characterized in that Each annular band has a normal state of bearing physiological stress after being implanted in the body and an expanded diameter state of expanding under a stress greater than the physiological stress. The deformed section of the second annular band inclines towards the blood flow channel side in the expanded diameter state relative to the normal state.

30. The surgical artificial heart valve according to claim 1, characterized in that supporting pieces extending towards the outflow side are provided on both circumferential sides of the deformed section on the second annular band.

31. The surgical artificial heart valve according to claim 1, characterized in that In the overall shape of the annular band, in the first annular band, the outflow side edge of the connecting part between two adjacent extending strips is a smooth curve.

32. The surgical artificial heart valve according to claim 31, characterized in that The outflow side edge of the corresponding part in the second annular band is a smooth curve.

33. The surgical artificial heart valve according to claim 32, characterized in that Threading holes are provided on the extending strips.

34. The surgical artificial heart valve according to claim 30, characterized in that The inflow side of the extending strip of the first annular band is a triangular area, and the deformed section on the second annular band together with the supporting pieces on both sides abuts against the triangular area under the normal state.

35. The surgical artificial heart valve according to claim 34, characterized in that Along the axial direction of the support structure, the deformed section on the second annular band is higher than the supporting pieces on both sides of the deformed section.

36. The surgical artificial heart valve according to claim 30, characterized in that A narrow and long opening opening towards the outflow side is provided between the deformed section on the second annular band and the supporting pieces on both sides.

37. The surgical artificial heart valve according to claim 36, characterized in that The inflow side of the narrow and long opening is closed, and the inner edge of the closed part is arc-shaped.

38. The surgical artificial heart valve according to claim 1, characterized in that A pulling member is connected between the two annular bands, and the connecting part of the pulling member is adjacent to the deformed section of each annular band.

39. The surgical artificial heart valve according to claim 38, characterized in that The pulling member is distributed at the positions of the deformed sections on the two annular bands.

40. The surgical artificial heart valve according to claim 38, characterized in that The pulling member is only distributed at the positions of the deformed sections on the two annular bands.

41. The surgical artificial heart valve according to claim 38, characterized in that The pulling member is a rigid member, and is grouped in pairs, and a group of pulling members is arranged on both circumferential sides of each deformed section.

42. The surgical artificial heart valve according to claim 38, characterized in that The pulling member is a flexible member, and binds and fixes the two annular bands.

43. The surgical artificial heart valve according to claim 38, characterized in that At least one of the annular bands is provided with a connecting hole for the pulling member to pass through.

44. The surgical artificial heart valve according to claim 43, characterized in that The connecting holes are respectively provided on both sides of the release deformation opening on the first annular band.

45. The surgical artificial heart valve according to claim 1, characterized in that The material of at least one of the two annular bands is metal, and the material of the other of the two annular bands is metal or plastic.

46. The surgical artificial heart valve according to claim 45, characterized in that, the material of the first annular band is plastic, and the material of the second annular band is metal.

47. The surgical artificial heart valve according to claim 46, characterized in that, the material of the first annular band is one or more of ABS plastic, acrylic resin, polyvinyl chloride, polycarbonate, polypropylene, polyethylene, polyoxymethylene, polyamide, fluorinated ethylene propylene, polyetherimide, polyether ether ketone, polytetrafluoroethylene, polyester, polysulfone.

48. The surgical artificial heart valve according to claim 46, characterized in that, the material of the second annular band is one or more of stainless steel, titanium alloy, cobalt-based alloy, nitinol.

49. The surgical artificial heart valve according to claim 45, characterized in that, each annular band is independently an integral ring or formed by strip-shaped members, and the two ends of the strip-shaped members are overlapped and welded together.

50. The surgical artificial heart valve according to claim 1, characterized in that, the surgical artificial heart valve further includes a metal frame around the blood flow channel, and the edges of each leaflet include a fixed edge and a movable edge that enclose each other, wherein the fixed edge is connected to the metal frame, the movable edge is located in the blood flow channel, and the movable edges of adjacent two leaflets are joined together.

51. The surgical artificial heart valve according to claim 50, characterized in that, a suture ring is fixed on the inflow side of the support structure, and the whole of each annular band and the suture ring is covered by a first wrapping layer; wherein the whole of the metal frame is covered by a second wrapping layer, and the metal frame is butted on the outflow side of the first annular band.

52. The surgical artificial heart valve according to claim 50, characterized in that, the shape of the metal frame is adapted to the shape of the edge of the outflow side of the first annular band.

53. The surgical artificial heart valve according to claim 1, characterized in that, the deformation section of at least one of the first annular band or the second annular band allows it to expand, and at the same time defines the maximum expansion diameter of at least one of the first annular band or the second annular band.

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