Degradable valve stent, valve stent for pulmonary arterial valve, pulmonary arterial valve, and heart valve

Abstract

The present application belongs to the technical field of interventional medical instruments, and particularly relates to a degradable valve stent, a valve stent for a pulmonary arterial valve, a pulmonary arterial valve, and a heart valve. The degradable valve stent comprises a stent body, which is constructed in a preset shape, and a proximal body and a distal body, which are respectively connected to two axial ends of the stent body, wherein the stent body, the proximal body and the distal body, as a whole, form a circumferentially closed annular structure; and at least part of each of the stent body, the proximal body and the distal body are degradable, such that the circumferentially closed annular structure of the degradable valve stent can be deconstructed. The heart valve comprises valve leaflets and the degradable valve stent, wherein the valve leaflets are connected to the degradable valve stent. The strength of a radial supporting force of the degradable valve stent provided in the present application meets application requirements; moreover, the degradable valve stent itself is degradable, and can be broken down, such that the circumferentially closed annular structure can be deconstructed, and does not cause difficulties and obstacles for subsequent implantation, thereby better meeting usage requirements.

Description

Degradable valve frame, valve frame for pulmonary valve, pulmonary valve and heart valve

[0001] This application claims priority to the Chinese patent applications filed with the State Intellectual Property Office on July 28, 2023, with application number 202310945501.6 and application name “A degradable valve frame and heart valve”, and filed with the State Intellectual Property Office on July 28, 2023, with application number 202310954713.0 and application name “A valve frame and pulmonary valve for pulmonary valve”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application belongs to the technical field of interventional medical devices, and specifically relates to a degradable valve frame, a valve frame for a pulmonary valve, a pulmonary valve, and a heart valve. Background Art

[0003] Valvular heart disease is a common heart disease with both congenital and acquired causes. Congenital refers to valvular disease detected at birth, while acquired refers to gradual damage that develops over years of constant opening and closing of the valve, leading to valvular stenosis or insufficiency, and poor blood flow or backflow. With the aging population, valvular disease in the elderly, as well as valvular disease caused by coronary artery disease and myocardial infarction, are becoming increasingly common. Currently, common treatments for this type of disease include valve replacement through surgery or minimally invasive transcatheter implantation. Because current technology makes it difficult to directly sew an external valve to the heart's annulus and maintain a good closure, both commonly used surgical and implanted valves utilize a valve frame to position and secure the valve, which is then surgically or implanted into place to address the stenosis or insufficiency of the diseased valve.

[0004] The valve frames of currently marketed valves are generally made of non-degradable materials, such as 316L stainless steel, nickel-titanium alloy, and cobalt-chromium alloy. These materials, as foreign materials, are present in the human body for a long time and can easily cause excessive intimal proliferation, leading to mid- to late-stage restenosis, chronic inflammation, and late- and very-late-stage thrombosis. They can also make secondary implantation difficult. This is especially true for patients with congenital valvular disease, as their hearts grow with age and the valve size needs to be adjusted. If the previously implanted valve frame is non-degradable ("degradable" refers to the frame breaking apart circumferentially and no longer forming a closed annular structure, thus losing its radial support capacity and no longer being limited to the radially supported range), subsequent reimplantation of the valve frame will inevitably be limited, creating significant difficulties and posing numerous health risks to the patient. Therefore, there is a need to develop an absorbable valve frame that can provide support while also being able to gradually degrade and decompose, or even be absorbed by the body until it disappears completely, thus avoiding the presence of multiple valve frames in the body and the attendant safety risks.

[0005] Summary of the Invention

[0006] The purpose of this application is to overcome the above-mentioned technical problems and provide a degradable valve frame, a valve frame for a pulmonary valve, a pulmonary valve and a heart valve.

[0007] In a first aspect, the present application proposes a degradable valve frame, comprising a frame body formed in a preset shape, and a proximal body and a distal body connected to the frame body at either axial end. The frame body, the proximal body, and the distal body collectively form a circumferentially closed annular structure. The frame body, the proximal body, and the distal body are at least partially degradable, so that the circumferentially closed annular structure of the degradable valve frame can be decomposed. The degradable valve frame of the present application has excellent mechanical properties, can effectively support, requires little material, and has a short degradation cycle, meeting the requirements of not restricting the reimplantation of the valve frame and avoiding the presence of multiple valve frames in the body.

[0008] A second aspect of the present application provides a pulmonary valve stent, comprising a tubular stent, and a proximal body and a distal body connected to the stent at either axial end. The stent comprises a plurality of cellular structures, and the distal body comprises a plurality of unit bodies having an "M"-shaped profile. The number of the unit bodies is m, where m is a natural number greater than or equal to 2. The pulmonary valve stent of the present application not only meets the requirements of the pulmonary valve, but also allows for uniform expansion and provides excellent reliability.

[0009] A third aspect of the present application provides a valve frame for a pulmonary valve, comprising the aforementioned degradable valve frame, wherein the distal body comprises a plurality of unit bodies having an "M"-shaped outline, wherein the number of the unit bodies is m, and m is a natural number greater than or equal to 2. The valve frame for the pulmonary valve of the present application has excellent mechanical properties, can effectively support, uses less material, and has a short degradation cycle. It meets the requirements of not restricting the re-implantation of the valve frame and avoiding the presence of multiple valve frames in the body. It can not only meet the requirements of the pulmonary valve, but also can expand evenly and has good reliability.

[0010] In a fourth aspect, the present application proposes a pulmonary valve, comprising leaflets and the above-mentioned valve frame for the pulmonary valve, wherein the leaflets are connected to the valve frame for the pulmonary valve.

[0011] In a fifth aspect, the present application proposes a heart valve comprising leaflets and the above-mentioned degradable valve frame, wherein the leaflets are connected to the degradable valve frame.

[0012] The present application provides a degradable valve frame and heart valve, which includes a frame body, a proximal body, and a distal body. The proximal body and the distal body are respectively connected to the axial ends of the frame body, and the frame body, the proximal body, and the distal body as a whole form a circumferentially closed annular structure, and the frame body, the proximal body, and the distal body are all configured to be at least partially degradable. In this way, the degradable valve frame of this structure not only has degradable properties itself, but can also be decomposed and absorbed within a preset time, so that the circumferentially closed annular structure of the valve frame is deconstructed, and the radial support range is no longer restricted, which will not cause difficulties and obstacles to subsequent implantation. In addition, the degradable valve frame as a whole also has good support performance, and the strength of the radial support force meets the application requirements, thereby achieving that the heart valve can be effectively supported and degraded by using the degradable valve frame, and it does not impose restrictions on re-implantation, and well meets the use requirements of the stent's support performance and degradability.

[0013] A valve frame and a pulmonary valve for a pulmonary valve provided in an embodiment of the present application, the valve frame includes a frame body, a proximal body and a distal body, and the proximal body and the distal body are respectively connected to the two ends of the frame body. A plurality of pore structures are provided on the frame body, and the distal body is provided as a plurality of unit bodies with an "M"-shaped outline, and each unit body is connected to the frame body. In this way, during the expansion process of the valve frame as a whole, the "M"-shaped unit body can achieve the pulling of each connection point and the constraint of the expansion path. At the same time, combined with the pulling and restraining effect of each pore structure during the expansion, the entire valve frame can be expanded uniformly, and the overall shape consistency is good. By adopting this valve frame, the pulmonary valve can expand uniformly, which well meets the use requirement that the pulmonary valve can expand uniformly, and has good reliability. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Various other advantages and benefits will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiment below. The accompanying drawings are for illustration purposes only and are not to be considered as limiting the present application. Throughout the drawings, the same reference numerals are used to denote the same components.

[0015] FIG1 is a schematic diagram of the structure of the degradable valve frame after expansion provided by an embodiment of the present application;

[0016] FIG2 is a planar schematic diagram of the degradable valve frame provided in an embodiment of the present application in a compressed state;

[0017] FIG3 is a planar schematic diagram of the degradable valve frame provided in an embodiment of the present application in a compressed state;

[0018] FIG4 is a schematic diagram of the structure of the second degradable valve frame after expansion provided in an embodiment of the present application;

[0019] FIG5 is an exploded schematic diagram of the degradable valve frame after expansion provided by an embodiment of the present application;

[0020] FIG6 is a schematic structural diagram of a second distal body in a degradable valve frame provided in an embodiment of the present application;

[0021] FIG7 is a schematic structural diagram of a third distal body in a degradable valve frame provided in an embodiment of the present application;

[0022] FIG8 is a schematic structural diagram of a unit body provided in an embodiment of the present application;

[0023] FIG9 is a schematic diagram of a partial structure of the distal body provided in an embodiment of the present application. DETAILED DESCRIPTION

[0024] The following describes exemplary embodiments of the present application in more detail with reference to the accompanying drawings. Although exemplary embodiments of the present application are shown in the accompanying drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. Instead, these embodiments are provided to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

[0025] It should be noted that the symbol “ / ” in this application represents the meaning of “or”, such as “A / B” means “A or B”, and “A and / or B” means “A and B, or A or B”.

[0026] For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figures, such as "inside," "outside," "inside," "outside," "below," "beneath," "above," and the like. Such spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "below" another element or feature would then be oriented as "above" or "above" another element or feature. Thus, the example term "below" can include both above and below orientations. The device may be otherwise oriented (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein are interpreted accordingly.

[0027] Test method:

[0028] 1. Radial support force of the stent

[0029] The present invention uses a radial support force tester produced by Blockwise to test the radial support force of the valve frame as a whole and the proximal body, distal body and frame of the valve frame in the following manner:

[0030] Method for testing the overall radial support force of the valve frame: After the valve frame (stent) is expanded to its rated diameter D, the part of the valve frame to be tested is placed in the radial support force tester to simulate the actual stress state of the valve frame in the blood vessel. The entire valve frame is compressed and deformed under the action of the pressure head, and the pressure exerted on the valve frame when its diameter is reduced to 90% of its rated diameter D during the radial compression process is measured.

[0031] The radial support force test method of the proximal body, distal body and frame body: After the stent is expanded to its rated diameter D, due to the flared end of the stent, the stent is first compressed to the middle diameter as a whole, and then the frame body, proximal body and distal body are cut off separately, and the stent part to be tested is placed in the radial support force tester to simulate the actual stress state of the stent in the blood vessel, so that the stent part is compressed and deformed under the action of the pressure head, and the pressure exerted on the stent when the diameter of the stent part is reduced to 90% of the rated diameter D of the stent during the radial compression process is measured.

[0032] 2. Bracket anti-parallel plate extrusion force

[0033] The test of the stent's resistance to parallel plate extrusion force in the present invention is carried out on a microcomputer-controlled universal mechanical testing machine. The stent is first expanded to its rated diameter D, at which point the stent's length is L. The stent is then placed between two parallel plates. The extrusion force N exerted by the parallel plates on the stent when the stent is compressed to 50% of its rated diameter between the parallel plates is measured. 平行板The anti-parallel plate extrusion force F of the bracket can be calculated according to the following formula: 平行板 , as follows:

[0034] It should be noted that for the petal frame with a flared end, the petal frame must be compressed as a whole to the same diameter as the frame body before testing.

[0035] As shown in Figures 1 and 2, a degradable valve frame 1 is provided in one embodiment of the present application. The degradable valve frame 1 includes a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is configured into a preset shape according to the requirements of use, and is a hollow structure to form a channel for blood flow. The cross-sectional profile of the frame body 11 perpendicular to the axis is circular. Of course, it is understandable that other shapes such as hexagons or octagons can also be configured according to the requirements of use. The proximal body 12 and the distal body 13 are respectively connected to the axial ends of the frame body 11, and the frame body 11, the proximal body 12, and the distal body 13 as a whole form a circumferentially closed annular structure, so that the overall structure is stable and can have good support performance. Among them, the frame 11, the proximal body 12 and the distal body 13 as a whole constitute a circumferentially closed annular structure. The frame 11, the proximal body 12 and the distal body 13 can be three circumferentially closed annular structures respectively, and after being connected, the whole is still a circumferentially closed annular structure; or it can be a circumferentially closed annular structure formed as a whole after the three are connected.

[0036] In the embodiment of the present application, the proximal body 12 and the distal body 13 are defined as follows: taking the distance between the entire degradable valve frame 1 and the heart after being implanted into the living body as a reference, the end close to the heart is the proximal body 12, and the end away from the heart is the distal body 13.

[0037] The degradable valve frame 1 provided in the embodiment of the present application is configured to be at least partially degradable on the frame body 11, the proximal body 12, and the distal body 13, so that the circumferentially closed annular structure of the degradable valve frame 1 is deconstructed. That is, each degradable portion breaks after being decomposed, destroying the circumferentially closed structure of the valve frame. Specifically, the frame body 11, the proximal body 12, and the distal body 13 are each configured to be at least partially degradable. After each degradable portion is degraded, each degradable location breaks. Under the joint action of each broken portion, the entire valve frame can be deconstructed in the circumferential direction, no longer being a closed annular structure, thereby losing the restriction of the radial support range and no longer having the limiting ability, and can be expanded, thereby not restricting the subsequent re-implantation of a valve frame with a larger radial size. This well meets the use requirements of the valve frame having degradable properties and not restricting the subsequent re-implantation of the valve frame.

[0038] The degradable valve frame 1 provided in the embodiments of the present application comprises a frame body 11, a proximal body 12, and a distal body 13, forming a circumferentially closed annular structure. Furthermore, at least portions of the frame body 11, the proximal body 12, and the distal body 13 are degradable. After the degradable portions are degraded, the circumferentially closed annular structure of the valve frame can be decomposed and expanded. This degradable valve frame 1 is not only inherently degradable and capable of being degraded and absorbed within a preset timeframe, preventing premature degradation and subsequent implantation difficulties and obstacles, but also has a stable overall structure, providing suitable support performance, a radial support force strength that meets application requirements, and excellent reliability.

[0039] In some possible embodiments, the total surface area of ​​the degradable portion of the degradable valve frame 1 accounts for greater than or equal to 0.5% of the total surface area of ​​the degradable valve frame 1. Furthermore, the total surface area of ​​the degradable portion of the degradable valve frame accounts for greater than or equal to 5% of the total surface area of ​​the degradable valve frame 1. Furthermore, the total surface area of ​​the degradable portion of the degradable valve frame accounts for greater than 99% of the total surface area of ​​the degradable valve frame 1. To ensure that the degradable portion effectively breaks and decomposes the valve frame after degradation, the area of ​​the degradable portion must be large enough. The "total surface area of ​​the degradable valve frame 1" refers to the sum of the area of ​​the outer wall and the area of ​​the sidewalls of the degradable valve frame 1. The sidewalls refer to the surface connecting the outer wall and the inner wall, while the inner wall refers to the surface opposite the outer wall and also the inner wall of the valve frame lumen. The "total surface area of ​​the degradable portion" refers to the total area of ​​the degradable portion within the total surface area of ​​the degradable valve frame 1. In an embodiment of the present application, the ratio of the total surface area of ​​the degradable part to the total surface area of ​​the degradable valve frame 1 as a whole can be optionally set to the above-mentioned numerical range, such as greater than or equal to 0.5%, or greater than or equal to 5%, or greater than or equal to 99%, and the ratio can also be adjusted according to actual design requirements, on the premise that the valve frame can finally be reliably deconstructed during the degradation process.

[0040] The degradable valve frame 1 provided in the embodiment of the present application has a radial support force of [6kPa, 140kPa]. Further, the radial support force is [20kPa, 80kPa]; further, the radial support force is [12kPa, 58kPa]; further, the radial support force is [20kPa, 58kPa]. The radial support force refers to the ability of the degradable valve frame 1 to resist radial compression force. In this way, the degradable valve frame 1 has a radial support force of appropriate size, and the appropriate radial support force can ensure that the degradable valve frame 1 is easy to position on the valve annulus and the valve is not easily washed away by the blood flow. At the same time, it also avoids the radial support force of the degradable valve frame 1 being too large, causing damage to the valve annulus and the aorta, and being unfavorable for compressing the valve for delivery. The degradable valve frame 1 has an appropriate support force and can meet the requirements for support force.

[0041] In some possible embodiments, the radial support force of the degradable valve frame 1 is [10kPa, 120kPa]; further [12kPa, 100kPa]. The radial support force in the above numerical range better meets the current use requirements for the radial support force size performance required of the valve frame. That is, the valve frame has a radial support force that meets the use requirements, which can not only effectively support the blood vessels and maintain the stability of the support position, but also facilitate the compression and transportation of the valve frame, reducing the difficulty of operating the valve frame. Specifically, the different radial support force performances possessed by the degradable valve frame 1 can be simultaneously possessed on the same degradable valve frame 1, or can be implemented separately on different degradable valve frames 1. In this way, the corresponding specifications and models can be selected according to the actual use requirements, and the design flexibility is good to meet the use requirements in different situations.

[0042] In some possible implementations, the frame 11, proximal body 12, and distal body 13 can all be configured to be fully degradable, meaning the entire valve frame is fully degradable. This allows degradation to occur at any location within the frame. During degradation, only the circumferential closure structure of the frame needs to be destroyed at the locations where degradation occurs, without having to wait for the entire frame to degrade. This increases the likelihood of degradation and fracture, further enhancing the reliability of the frame's circumferential closure structure being destroyed after degradation, eliminating the radial support range restriction.

[0043] In the embodiment of the present application, in order to achieve that the valve frame can degrade within a preset time after being implanted in a living body without restricting subsequent re-implantation, the degradable valve frame 1 is set to be partially degradable or entirely degradable. When it is partially degradable, the degradable position can be set to enable the valve frame to be decomposed as a whole and no longer restrict the newly implanted valve. For example, if the degradable part is set to be in the same straight line in the axial direction, it can be broken along the path after degradation, so that the integrity of the valve frame is destroyed, the original circumferential restriction performance disappears, and it can be expanded, and then the valve frame can be re-implanted. When it is completely degradable, that is, any position of the entire degradable valve frame 1 can be degraded, the possibility of the valve frame being degraded and broken is increased. During the degradation process, as long as the parts that break after degradation can cause the closed structure of the valve frame in the circumferential direction to be destroyed, the overall decomposition of the valve frame can be achieved, and it can be expanded, so that the valve frame no longer has the ability to limit the radial support range, meeting the use requirements of re-implantation.

[0044] Specifically, the time it takes for the degradable valve frame 1 to degrade to overall deconstruction is kept within a preset time period, and there will be no risk of premature deconstruction leading to loss of support performance and restenosis of the supported area. There will also be no problem of not deconstructing beyond the preset time period, which will limit reimplantation and make it impossible to reimplant the valve frame in the same position. The deconstruction time of the degradable valve frame 1 is at least not less than 1 year, and the degradable material is completely degraded in 3-5 years. Among them, when the degradable valve frame 1 is made entirely of degradable materials, the valve frame is a fully degradable valve frame, and within 3-5 years, the valve frame is completely degraded and absorbed by the body until it completely disappears. In this way, not only is it possible to provide reliable support to the blood vessels within the specified time, but it can also be completely degraded and will not remain in the body, which facilitates the reimplantation of the valve frame and avoids the long-term safety hazards caused by the presence of multiple valve frames in the body.

[0045] The degradable valve frame 1 provided in the present application has a coverage rate of [4%, 18%]; further, a coverage rate of [4%, 15%]; further, a coverage rate of [4%, 10%]; and further, a coverage rate of [4%, 8%]. Setting the coverage rate of the degradable valve frame 1 within these numerical ranges can meet the use requirements, and the smaller the coverage rate, the less material the valve frame uses, which is more conducive to reducing the absorption burden in the patient's body. Therefore, different degradable valve frames 1 can be set to match the coverage rates in the above numerical ranges, such as a coverage rate of 4% for one degradable valve frame 1, a coverage rate of 8% for another degradable valve frame 1, and a coverage rate of 12% for another degradable valve frame 1, etc. In this way, in actual applications, the degradable valve frame 1 with the most appropriate coverage rate can be selected according to specific needs, thereby improving the accuracy of the use of the degradable valve frame 1 and the scope of application.

[0046] It should be noted that the "coverage rate of the degradable valve frame 1" mentioned here refers to the coverage rate corresponding to the valve frame as a whole.

[0047] The "coverage rate" mentioned in this application refers to the surface coverage rate of the material after the valve frame is expanded to the rated diameter, that is, the ratio of the surface area covered by the valve frame material to the total surface area of ​​the valve frame covering section, and the formula is as follows:

[0048] Surface coverage = A = Sr / Ss × 100%;

[0049] Where: Sr: the area actually filled / occupied by the outer surface of the petal frame pattern after expansion. The outer surface area of ​​the petal frame is measured using CAD software;

[0050] Ss: the total surface area of ​​the valve frame covered segment after expansion, Ss = π × D1 × L1;

[0051] D1: valve frame diameter after expansion;

[0052] L1: Length of the valve frame after expansion.

[0053] The degradable valve frame 1 provided in the embodiment of the present application has a wall thickness of 0.10mm-0.40mm; further, the wall thickness is 0.15mm-0.4mm, and further, the wall thickness is 0.18mm-0.35mm. For patients, the valve frame, as an in vitro implant, will produce corresponding rejection reactions after being implanted in the body, which will cause a certain burden on the patient's body. Therefore, the thicker the wall thickness of the valve frame, the higher the coverage rate, and the stronger the support for the blood vessels, but at the same time, the more material is used, and the more disadvantageous it is to the body. Especially when the material of the valve frame is degradable, the more material is used, the more products are produced after degradation in the body, and the heavier the burden of absorption / clearance products on the patient's body. By controlling the coverage rate and / or wall thickness of the valve frame, the present application can not only ensure that the amount of material used for the degradable valve frame 1 is as small as possible, reducing the burden of absorption / clearance products in the patient's body, but also provide sufficient support for the valve ring. At the same time, by controlling the wall thickness, the time it takes for the valve frame to degrade to overall deconstruction can also be controlled. Appropriate wall thickness is conducive to the degradation and deconstruction of the valve frame within a preset time, thereby meeting the time requirements for the valve frame to be able to support and completely deconstruct.

[0054] The degradable valve frame 1 provided in the present application has an anti-parallel plate extrusion force of not less than 0.05N / mm, or not less than 0.1N / mm, and the specific numerical range can be adjusted according to the requirements of different application scenarios. The "anti-parallel plate extrusion performance" evaluates the ability of the degradable valve frame 1 to resist permanent deformation when subjected to a load uniformly distributed along the length of the entire stent. When the anti-parallel plate extrusion force is within this numerical range, the degradable valve frame 1 has good anti-flattening performance, which can meet the use requirements of being subjected to extrusion force in the radial direction along the length of the entire stent. In this way, the damage caused to the degradable valve frame 1 when it is flattened by radial extrusion can be reduced, such as causing deformation of the lumen or loss of support of the valve frame or displacement of the leaflets. The degradable valve frame 1 has a suitable anti-parallel plate extrusion force, which can greatly improve the safety and reliability of use.

[0055] In an embodiment of the present application, the degradable valve frame 1 is a valve frame for the pulmonary valve, with a radial support force of [10kPa, 80kPa], a valve frame coverage rate of [4%, 13%], and a wall thickness of 0.15mm-0.35mm; or the degradable valve frame 1 is a valve frame for the aortic valve, with a radial support force of [30kPa, 120kPa], a valve frame coverage rate of [5%, 15%], and a wall thickness of 0.18mm-0.40mm; or the degradable valve frame 1 is a valve frame for the mitral valve, with a radial support force of [30kPa, 100kPa], a valve frame coverage rate of [5%, 13%], and a wall thickness of 0.18mm-0.35mm; or the degradable valve frame 1 is a valve frame for the tricuspid valve, with a radial support force of [30kPa, 110kPa], a valve frame coverage rate of [5%, 14%], and a wall thickness of 0.18mm-0.38mm.

[0056] In other embodiments, the degradable valve frame is a valve frame for the pulmonary valve, with a radial support force of [6kPa, 80kPa], a valve frame coverage rate of [4%, 13%], and a wall thickness of 0.15mm-0.35mm; or the degradable valve frame is a valve frame for the aortic valve, with a radial support force of [30kPa, 140kPa], a valve frame coverage rate of [5%, 18%], and a wall thickness of 0.18mm-0.40mm; or the degradable valve frame is a valve frame for the mitral valve, with a radial support force of [12kPa, 100kPa], a valve frame coverage rate of [5%, 13%], and a wall thickness of 0.15mm-0.35mm; or the degradable valve frame is a valve frame for the tricuspid valve, with a radial support force of [30kPa, 110kPa], a valve frame coverage rate of [5%, 14%], and a wall thickness of 0.15mm-0.38mm.

[0057] The degradable valve frame 1 provided in the present application has an axial deformation resistance of not less than 0.3N; or not less than 1N. The specific numerical range can be adjusted according to the requirements of different application scenarios. "Axial deformation resistance" refers to the force required when the degradable valve frame 1 undergoes irreversible deformation during continuous axial pressure. The deformation resistance within this numerical range gives the degradable valve frame 1 good axial support performance and can meet the use requirements of axial force and pressure resistance. In this way, it can reduce the damage caused by the degradable valve frame 1 when it undergoes irreversible deformation under axial pressure, such as changes in the axial support position, resulting in a poor or failed support effect, or the generation of protrusions or sharp points facing the tissue, which may puncture the tissue, and other uncontrollable adverse effects. For example, in a scenario where the end of the degradable valve frame 1 needs to be inserted into the tissue, if the strength of the axial support force is too weak, it is easy for the degradable valve frame 1 to fail to penetrate the tissue, or when it is subsequently subjected to axial pressure, the degradable valve frame 1 may deform and detach from the tissue, resulting in the risk of displacement. The degradable valve frame 1 has a suitable axial supporting force, which can greatly improve the safety and reliability of use.

[0058] As shown in Figures 1 and 4, in the embodiments of the present application, the frame 11, the proximal body 12, and / or the distal body 13 each include several cellular structures 14, each of which is fully enclosed. By providing a fully enclosed cellular structure 14, each connection point can support each other, resulting in high structural strength. This not only ensures that the overall support performance of the degradable valve frame 1 meets application requirements, but also enables the degradable valve frame 1 to achieve uniform expansion during expansion due to the mutual pulling action of the connection points. Furthermore, the cellular structure 14 is hollow, which can also reduce the amount of material used in the degradable valve frame 1 and improve the efficiency of degradation of the degradable valve frame 1. Specifically, the shape of the cellular structure 14 can be various, such as a regular polygon or circle (such as a quadrilateral in Figure 1 or a hexagon in Figure 4), or other irregular shapes, providing good flexibility. The shape of the cellular structure 14 is not limited herein.

[0059] As shown in Figures 1 and 5, in one possible embodiment, the lattice structure 14 on the frame 11 can be configured to include crests 141 and troughs 142 (defined along the direction from the proximal body 12 to the distal body 13). Specifically, the lattice structure 14 is configured as a regularly shaped, corrugated structure. Each lattice structure 14 is evenly distributed along the circumference of the frame 11, connected end to end and closed in the circumferential direction, so as to provide at least the required radial support performance. The regularly shaped lattice structure 14 also ensures that during expansion, each lattice structure 14 is subjected to uniform force, achieving uniform expansion. Specifically, the angle α1 between two adjacent support rods 143 forming the crests 141 or troughs 142 on the frame 11 is 50°-160°. Preferably, α1 can be 60°-140°, 60°-120°, 70°-110°, or 80°-100°.

[0060] Further, as shown in Figure 4, in a possible embodiment, the angle α2 between two adjacent support rods used to form the peak n1 or trough n2 of the proximal body 12 and / or the distal body 13 is 40°-179°; preferably, α2 can be 50°-175°; more preferably, α2 can be 65°-175°.

[0061] Specifically, the larger the angle formed by adjacent support rods on the same cellular structure 14, the less likely the corrugated structure is to be compressed, and the higher the radial support force. However, if the angle is too large, the stent is subjected to greater forces at the crests and troughs, making it more susceptible to expandable fracture or long-term fatigue fracture. In this application, by setting the angle between the two support rods corresponding to each position within the corresponding numerical ranges described above, the overall radial support force of the degradable valve frame 1 can be effectively improved, so that the overall mechanical properties of the degradable valve frame 1 meet the application requirements and the support reliability is good.

[0062] The biodegradable valve frame 1 provided herein has a total of 12-48 support rods 143 surrounding each cellular structure 14 at the same location on the frame 11 and along the circumferential direction of the frame 11. Furthermore, the total number of support rods 143 is 12-36. The number of support rods 143 can be appropriately adjusted based on the number of vascular branches near the valve frame implantation site and the magnitude of the radial force exerted on the valve frame by the surrounding tissue. When a branched vessel exists near the implantation site of the valve frame, the number of support rods 143 in the corresponding cellular structure 14 can be reduced based on the relative position of the branched vessel and the valve frame, so that the mesh is as large as possible relative to the opening of the branched vessel, thereby avoiding blocking the vessel opening and preventing blood flow obstruction in the branched vessel. When a portion of the valve frame is subjected to relatively small radial forces exerted by the surrounding tissue, the number of support rods 143 can also be appropriately reduced, so that the corresponding cellular structure 14 has sufficient mechanical properties while reducing the amount of valve frame material used, thereby reducing the burden of material absorption and the time required for degradation. If there are branched blood vessels at the distal end of the pulmonary valve, the number of support rods 143 at the distal end of the pulmonary valve stent can be reduced, such as 12. Generally, larger mesh holes are formed in the distal body 13 to avoid blocking the openings of the branched blood vessels. Furthermore, the radial support force on both ends of the pulmonary valve is relatively small, so not only can fewer support rods 143 be provided at the distal body 13, but also at the proximal body 12.

[0063] In the embodiment of the present application, the coverage of the distal body 13 is less than or equal to 6%. Optionally, when the structural strength of the distal body 13 meets the support requirements, setting the coverage of the distal body 13 to a smaller value indicates that less material is used in the distal body 13. This reduces the amount of degradation products produced, which is more conducive to improving the efficiency of degradation and absorption.

[0064] In the embodiments of the present application, the degradable valve frame 1 provided by the substrate of the degradable valve frame 1 has a yield strength of 350-1450 MPa; and / or the tensile strength of the substrate of the degradable valve frame 1 is 400-1500 MPa. Specifically, the substrate refers to the material used in the largest amount to constitute the valve frame. When part of the degradable valve frame 1 is made of degradable material, the substrate is a non-degradable material, and the degradable portion mainly serves as a connection. The yield strength of the substrate of the degradable valve frame 1 refers to the yield strength of the non-degradable material. For a partially degradable valve frame 1, the higher the strength of the non-degradable material, the greater the fracture resistance, which can reduce the risk of fracture caused by long-term presence of the stent in the body. In other embodiments of the present application, when the degradable valve frame 1 is made entirely of degradable material, the yield strength of the substrate of the degradable valve frame 1 is the yield strength of the degradable material. The higher the yield strength or tensile strength of the substrate, the less material is required to achieve the corresponding support effect, which is more conducive to reducing the absorption burden in the patient's body.

[0065] The degradable valve frame 1 provided in the present application, the material of the base material of the degradable part of the degradable valve frame 1 is at least one of metal or non-metal; wherein the metal includes at least any one of pure iron, iron alloy, pure magnesium, magnesium alloy, pure zinc or zinc alloy; the non-metal includes at least any one of degradable polyester, degradable polyanhydride and binary or multinary degradable copolymers copolymerized with the corresponding monomers thereof, and the degradable polyester includes at least one of polylactic acid, polyglycolic acid, polylactic glycolic acid, polycaprolactone, polylactide, polyglycolide, polycaprolactone, polyhydroxyalkanoate, polyacrylate, polysuccinate, poly(β-hydroxybutyrate), polyethylene adipate, and polyhydroxybutyrate valerate copolymer; The degradable polyanhydride includes at least one of poly 1,3-bis(p-carboxyphenoxy)propane-sebacic acid, polyerucic acid dimer-sebacic acid or polyfumaric acid-sebacic acid; or the non-metal includes at least one of a degradable polyamino acid and a degradable tyrosine-derived polymer, and the degradable polyamino acid includes at least one of polyglycine, polyalanine, polyvaline, polyleucine, polyisoleucine, polymethionine, polyproline, polytryptophan, polyserine, polytyrosine, polycysteine, polyphenylalanine, polyasparagine, polyglutamine, polythreonine, polyarginine, polyhistidine, polyselenocysteine, polypyrroline, polyglutamic acid, polyaspartic acid, polyornithine, polylysine and derivatives thereof;Degradable tyrosine-derived polymers include methyl (2R)-2-amino-3-(2-chloro-4-hydroxyphenyl) propionate, D-tyrosine ethyl ester hydrochloride, methyl (2R)-2-amino-3-(2,6-dichloro-3,4-dimethoxyphenyl) propionate HD-Tyr(TBU)-allyl ester HCl, methyl (2R)-2-amino-3-(3-chloro-4,5-dimethoxyphenyl) propionate, methyl (2R)-2-amino-3-(2-chloro-3-hydroxy-4-methoxyphenyl) propionate, methyl (2R)-2-amino-3-(4-[(2-chloro-6-fluorophenyl)methoxy]phenyl) propionate, methyl (2R)-2-amino-3-(2-chloro- 3,4-dimethoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(3-chloro-5-fluoro-4-hydroxyphenyl)propionic acid methyl ester, 2-(acetylamino)-2-(4-[(2-chloro-6-fluorobenzyl)oxy]benzylmalonate, (2R)-2-amino-3-(3-chloro-4-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(3-chloro-4-hydroxy-5-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(2,6-dichloro-3-hydroxy-4-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(3-chloro-4-hydroxyphenyl)propionic acid methyl ester, H-DL-tyr-OME HCl, H-3,5-diiodo-tyr-OME HCl, HD-3,5-diiodo-tyr-OME HCl, HD-tyr-OMEHCl, D-tyrosine methyl ester hydrochloride, D-tyrosine-ome HCl, D-tyrosine methyl ester hydrochloride, HD-tyr-OMe HCl, D-tyrosine methyl ester HCl, HD-Tyr-OMe-HCl, (2R)-2-amino-3-(4-hydroxyphenyl)propionic acid, (2R)-2-amino-3-(4-hydroxyphenyl)propionic acid methyl ester hydrochloride, (2R)-2-amino-3-(4-hydroxyphenyl)propionic acid methyl ester hydrochloride, (2R)-2-azanyl-3-(4-hydroxyphenyl)propionic acid methyl ester hydrochloride, 3-chloro-L-tyrosine, 3-nitro-L-tyrosine, 3-nitro-L-tyrosine ethyl ester hydrochloride, DL-m-tyrosine, DL-o-tyrosine, Boc-Tyr(3,5-I2)-OSu, Fmoc-tyr(3-NO2)-OH, α-methyl-L-tyrosine, α-methyl-D-tyrosine, and α-methyl-DL-tyrosine.

[0066] Taking the material of the degradable part as metal as an example, in some embodiments of the present application, the material of the degradable part is iron alloy; or the material of the degradable part is magnesium alloy or zinc alloy or some other alloy; or the material of the degradable part may be a combination of iron alloy and magnesium alloy, or a combination of magnesium alloy and zinc alloy, or a combination of iron alloy and zinc alloy, or a combination of iron alloy, zinc alloy and magnesium alloy.

[0067] It should be noted that the "alloy" in this application refers to the element contained in the alloy. For example, an iron alloy refers to an alloy containing iron, a zinc alloy refers to an alloy containing zinc, and a magnesium alloy refers to an alloy containing magnesium. Furthermore, an "alloy" may refer to an alloy in which the mass or volume content of the "element" is greater than or equal to 0.25%, and the remaining 99.75% of the components may be composed of any other metal elements and / or non-metal elements. For example, an iron alloy refers to an alloy in which the mass / volume content of the iron element is greater than or equal to 0.25%, and so on. Furthermore, the iron alloys in the present application include but are not limited to iron-manganese alloys, iron-zinc alloys, iron-magnesium alloys, iron-calcium alloys, iron-zirconium alloys, iron-manganese-carbon alloys, iron-molybdenum alloys, iron-manganese-copper alloys, iron-manganese-silicon-carbon alloys, iron-silicon-manganese alloys, iron-copper alloys, iron-copper-manganese-carbon alloys, iron-gold alloys, iron-silver alloys, iron-manganese-silver alloys, iron-magnesium alloys, iron-hydrogen alloys, iron-phosphorus alloys, iron-sulfur alloys, iron-manganese-carbon alloys, iron-boron alloys, iron-titanium alloys, and iron-titanium-carbon alloys; zinc alloys include but are not limited to zinc-aluminum alloys, zinc-silver alloys, zinc-iron alloys, zinc-copper alloys, zinc-iron-calcium alloys, and iron-manganese-copper-carbon alloys; magnesium alloys include but are not limited to magnesium-manganese alloys, magnesium-zinc alloys, magnesium-aluminum alloys, and magnesium-iron alloys.

[0068] Pure metal in this application means that the total content of other impurities in the metal is less than or equal to 0.5 wt.%. For example, pure iron means that the total amount of other metals and / or non-metals other than iron in the metal is less than or equal to 0.5 wt.%.

[0069] In the embodiments of the present application, the degradable valve frame 1 made of the aforementioned materials not only degrades within a predetermined timeframe, eliminating the limiting effect through degradation after implantation and preventing reimplantation, but also exhibits superior radial support performance, with the radial support force effectively supporting the blood vessels and resisting external pressure, preventing collapse and demonstrating superior support reliability. Furthermore, the support force provided does not complicate transportation and use, facilitating compression and delivery, demonstrating a sophisticated design.

[0070] As shown in Figures 1 and 5, in some possible embodiments, the cellular structure 14 is a regular polygon, such as a quadrilateral, hexagon, heptagon, or octagon. Alternatively, the cellular structure 14 may be an irregular polygon. As long as the shape satisfies the requirements of uniform expansion and reliable support, the irregular polygon can be any shape. Of course, it is understood that in other possible embodiments, the polygonal cellular structures 14 may be both regular and irregular.

[0071] In some possible embodiments, the irregular polygons can be distributed at any location (on the proximal body 12, distal body 13, and frame body 11) of the biodegradable valve frame 1, such as the polygons on the proximal body 12 are irregular, while the polygons on other locations are regular; or the polygons on the distal body 13 are irregular, while the polygons on other locations are regular; or the polygons on the frame body 11 are irregular, while the polygons on other locations are regular. In some embodiments, the irregular polygons are non-uniformly distributed; or the irregular polygons are evenly distributed; or the irregular polygons are distributed at more than one location on the proximal body 12, distal body 13, and frame body 11.

[0072] The biodegradable valve frame 1 provided in the present application is connected directly or through a first connecting rod 111 along the direction from the proximal body 12 to the distal body 13, with the peak 141 of the nth pore structure 14 on the frame 11 and the trough 142 of the n+1th pore structure 14, where n≥1. That is, as shown in FIG5 , in the same direction of the frame 11, the connection between two adjacent pore structures 14 can be a direct connection. As shown in FIG4 , it can also be indirectly connected through the first connecting rod 111. The specific connection method can be flexibly selected according to actual design requirements. The provision of the first connecting rod 111 increases the distance between two adjacent pore structures 14 in the length direction, thereby increasing the length of the frame 11. Compared with increasing the length of the frame 11 by increasing the number of pore structures 14 in the length direction, the use of the first connecting rod 111 can reduce the amount of material used and reduce the coverage rate of the frame 11. Of course, it is understandable that a length of the first connecting rod 111 that is too long will affect the structural strength of the frame 11. Therefore, setting the length of the first connecting rod 111 within the range of 0.10-3.0 mm can not only achieve the purpose of increasing the length of the frame 11, but also does not affect the structural strength of the frame 11, thereby meeting the use requirements of degradable valve frames 1 of different lengths.

[0073] It should be noted that the first connecting rod mentioned in this application can be linear or non-linear, such as S-shaped, ω-shaped or Ω-shaped.

[0074] As shown in FIG5 , the degradable valve frame 1 provided by the present application, the proximal body 12 and / or the distal body 13 are directly connected to the frame body 11 or connected through a second connecting rod 15. That is, the connection between the proximal body 12 and / or the distal body 13 and the frame body 11 can be direct connection or connected by a second connecting rod 15. The specific connection method can be selected according to the actual design requirements. In the embodiment of the present application, as shown in FIG5 , the proximal body 12 and the frame body 11 are connected by setting a second connecting rod 15, and the second connecting rod 15 is a straight rod. The setting of the second connecting rod 15 is equivalent to increasing the length of the overall structure of the proximal body 12, and can also make the proximal body 12 easier to bulge, expand into a cylinder or appear outward-turned trumpet shape, thereby improving the reliability of positioning with the implanted tissue.

[0075] Specifically, the proximal body 12 can be shaped as a continuously bent closed loop having multiple corrugated structures. When the proximal body 12 and the frame 11 are connected by a second connecting rod 15, one end of the second connecting rod 15 can be connected to a crest of the proximal body 12, and the other end can be connected to an adjacent trough 142 on the frame 11. Furthermore, the number of crests on the proximal body 12 is equal to the number of adjacent troughs 142 on the frame 11. Therefore, the second connecting rod 15 can be used to connect every two adjacent crests and troughs 142, or they can be connected at intervals. The crests and troughs mentioned are relative to the vertical orientation of the petal frame 1, with the proximal body 12 at the bottom and the distal body 13 at the top.

[0076] Furthermore, in some possible embodiments, the length of the second connecting rod 15 is 0.8mm-4.0mm; or the length of the second connecting rod 15 is 1.5mm-3.5mm. According to the design requirements, the second connecting rod 15 can be set to different lengths within this range, so that the proximal body 12 can be constructed into different specifications and shapes, with a wide range of applications. Moreover, if the length of the second connecting rod 15 is too long, it will affect the overall axial support strength and coverage of the degradable valve frame 1, while if the length of the second connecting rod 15 is too short, it will be difficult to process and manufacture. Therefore, setting the length of the second connecting rod 15 within the above-mentioned appropriate range can not only ensure that the overall axial support performance of the degradable valve frame 1 is reliable and the coverage is moderate, but also facilitate production and processing.

[0077] As shown in Figures 1 and 5, in some possible embodiments, the distal body 13 includes a first support body 131 and a second support body 132 that are interconnected at one end, and the end at which the first support body 131 and the second support body 132 are connected is connected to the frame body 11. Specifically, the first support body 131 and the second support body 132 are interconnected according to a preset shape to form an "M"-shaped outline with two sawtooth-like tops, and the heights of the two tops can be the same or different. Under this structure, the first support body 131 and the second support body 132 support each other, so that the distal body 13 has a more stable support performance and thus has better radial support force. Moreover, during expansion, the first support body 131 and the second support body 132 can pull each other, which is conducive to improving the uniformity of the overall expansion.

[0078] As shown in Figure 5, in some embodiments, the first support 131 is bent to form a peak n1, and the second support 132 is bent in the same direction to form a peak n2. The height of the peak n2 of the second support 132 is less than or equal to two-thirds of the height of the peak n1 of the adjacent first support 131. The lower the height of the peak n2, the less obstruction caused by the second support, which is more conducive to avoiding blocking distal branch vessels, thereby effectively preventing blockage of branch vessels. Of course, the height relationship between the peaks n1 and n2 can also be within other ranges, provided that the requirements are met.

[0079] As shown in Figure 5 , in one embodiment, the distal body 13 further includes a reinforcement member 133 disposed between the frame 11 and the distal body 13. The reinforcement member 133 is connected to at least the first support body 131. The two ends of the reinforcement member 133 are connected to the two side bars formed by bending the first support body 131, thereby reinforcing the two side bars and thereby enhancing the axial and radial support strength of the first support body 131. In another embodiment, referring to Figure 6 , one end of the reinforcement member 133 can be connected to the apex of the wave crest n1 formed by bending the first support body 131, and the other end can be connected to any side bar or the frame 11, thereby also achieving the effect of supporting and reinforcing the first support body 131. In this way, the supporting force provided by the reinforcement member 133 can enhance the support performance of the distal body 13 and improve its reliability. Furthermore, the pulling or limiting of the reinforcement member 133 facilitates the full expansion of the bent first support body 131.

[0080] As shown in FIG7 , in some possible embodiments, the reinforcement member 133 is positioned closer to the apex of the wave crest n1, preferably connected between the midpoint of the connected sidebar and the apex of the wave crest n1. Generally, since the apex of each wave crest n1 is the first part to be subjected to force, placing the reinforcement member 133 closer to the apex can enhance the strength of the apex, thereby improving the deformation resistance of the entire distal body 13.

[0081] The structural design of the distal body 13 in the above-mentioned degradable valve frame 1 can not only ensure the uniformity of the distal body 13 and even the entire degradable valve frame 1 during and after balloon expansion, but also ensure that the distal body 13 has sufficient supporting force in the axial direction, so that it can be stably fixed in the tissue in contact with the distal body 13, preventing the valve frame 1 from shifting, thereby improving the fixation effect of the degradable valve frame 1.

[0082] In some possible embodiments, the biodegradable valve frame 1 is entirely constructed from support rods made of corresponding materials. Starting from the midpoint of the frame 11, the axial cross-sectional area of ​​the support rods can gradually decrease in direction toward the proximal body 12 and distal body 13. Specifically, the axial cross-sectional area is greatest at the midpoint of the frame 11, and smallest at the apexes of the proximal and distal bodies 12 and 13. Optionally, the rate of change in the gradual decrease in the axial cross-sectional area of ​​the support rods can be set to 5%. This prevents the support rods from being excessively thick or thin, and reduces the material requirements of the proximal and distal bodies 12 and 13, facilitating degradation. This reduced material requirement is particularly beneficial in the portions of the proximal and / or distal bodies 12 and 13 that are not adherent to the blood vessel wall, improving degradation efficiency. Furthermore, the axial cross-sectional area of ​​the support rods increases from the proximal body 12 to the frame 11, and from the distal body 13 to the frame 11, providing the frame 11 with reliable axial support strength. This ensures that the biodegradable valve frame 1 resists axial deformation and is less prone to collapse.

[0083] In some possible embodiments, the ratio of the maximum diameter at the end of the degradable valve frame 1 to the minimum diameter in the middle is [1, 1.8]:1. When the ratio of the maximum diameter at the end of the valve frame to the minimum diameter in the middle is 1:1, the valve frame is cylindrical, and when the ratio of the maximum diameter at the end of the valve frame to the minimum diameter in the middle is greater than 1:1, the valve frame is trumpet-shaped. Furthermore, the ratio of the maximum diameter at the end of the degradable valve frame 1 to the minimum diameter in the middle is [1.1, 1.5]:1; further, the ratio is [1.1, 1.4]:1. The overall shape of the degradable valve frame 1 at different ratios is different, such as the size of the end is different. In this way, a more suitable valve frame can be set according to different application requirements, so that it can better fit the inner wall of the tissue after implantation, thereby improving applicability.

[0084] It should be noted that the "end" mentioned above refers collectively to the proximal body 12 and the distal body 13, that is, the end includes the proximal body 12 and the distal body 13; the "middle" mentioned above refers to the frame 11. Therefore, "the ratio of the maximum diameter of the end portion to the minimum diameter of the middle portion of the degradable valve frame 1 is [1.1, 1.8]:1" means that "the ratio of the maximum diameter of the distal body 13 to the minimum diameter of the frame 11 is [1.1, 1.8]:1; and the ratio of the maximum diameter of the proximal body 12 to the minimum diameter of the frame 11 is also [1.1, 1.8]:1."

[0085] Furthermore, the ratio of the maximum diameter of the proximal body 12 to the minimum diameter of the frame 11 may be equal to or different from the ratio of the maximum diameter of the distal body 13 to the minimum diameter of the frame 11. In other words, the maximum diameter of the proximal body 12 may be equal to or different from the maximum diameter of the distal body 13.

[0086] Furthermore, the ratio of the maximum diameter of the proximal body 12 to the minimum diameter of the frame 11 is greater than or equal to the ratio of the maximum diameter of the distal body 13 to the minimum diameter of the frame 11, that is, the maximum diameter of the proximal body 12 is greater than or equal to the maximum diameter of the distal body 13. As shown in FIG1 , in the biodegradable valve frame 1 provided herein, the length of the frame 11 is 15%-75% of the total frame length; or the length of the frame 11 is 20%-65% of the total frame length. While the total length of the valve frame 1 remains constant, different frame 11 lengths will result in different lengths of the proximal and distal bodies 12 and 13. If the frame 11 is longer, the proximal and / or distal bodies 12 and 13 may be shorter, resulting in a greater angle of inclination of the entire valve frame from the frame 11 to its ends. Conversely, if the frame 11 is shorter, the proximal and / or distal bodies 12 and 13 may be longer, resulting in a smaller angle of inclination of the entire valve frame from the frame 11 to its ends. In this way, the valve frame can have different shapes and a wide range of applications. In the embodiment of the present application, the length of the frame body 11 is designed within the above-mentioned numerical range to meet different design requirements.

[0087] As shown in Figure 1, the degradable valve frame 1 provided by the present application has an angle α3 between the line connecting the vertex of the distal body 13 and the midpoint of the frame body 11 and the central axis of the frame body 11, and an angle α4 between the line connecting the vertex of the proximal body 12 and the midpoint of the frame body 11 and the central axis of the frame body 11. The size of α3 or α4 is between (0°, 30°], where α3 = α4, or α3 ≠ α4, or α3 is less than α4.

[0088] In some embodiments of the present application, the sizes of α3 and α4 are both within the range of (0°, 30°]; in other embodiments of the present application, the angle α3 formed by the distal body 13 is within the range of (0°, 30°], and the angle α4 formed by the proximal body 12 is not within the range of (0°, 30°]; in other embodiments, the angle α3 formed by the distal body 13 is not within the range of (0°, 30°], and the angle α4 formed by the proximal body 12 is within the range of (0°, 30°].

[0089] Furthermore, in some embodiments of the present application, the angle α3 formed by the distal body 13 is equal to the angle α4 formed by the proximal body 12, that is, α3 = α4; while in other embodiments of the present application, the angles α3 and α4 are different, that is, α3 ≠ α4. Furthermore, the angle α3 formed by the distal body 13 is less than or equal to the angle α4 formed by the proximal body 12.

[0090] In the embodiment of the present application, α3 and α4 are set at different angles, respectively, so that the distal body 13 and the proximal body 12 can have different expansion degrees, that is, the distal body 13 and the proximal body 12 can have different sizes, thereby meeting the use requirements of blood vessels of different sizes.

[0091] A heart valve is also provided in an embodiment of the present application, comprising leaflets and the above-mentioned degradable valve frame 1, wherein the leaflets are connected to the degradable valve frame 1. The heart valve is achieved by using the above-mentioned degradable valve frame 11, and the above-mentioned degradable valve frame 11 not only has a suitable radial support force, can reliably support and expand evenly, but also has good resistance to axial deformation, has good axial support performance without support collapse. At the same time, it can also be degraded without restricting re-implantation, which well meets the use requirements that the heart valve can not only effectively support blood vessels and maintain the stability of the support position, but also has low difficulty in re-implantation operation. At the same time, the valve frame is completely degraded and absorbed by the body until it completely disappears, and will not remain in the body, avoiding the long-term safety hazards caused by the presence of multiple valve frames in the body.

[0092] The degradable valve frame 1 provided in the present application includes valve frames for mitral valve, tricuspid valve, aortic valve and pulmonary valve.

[0093] The degradable valve frame 1 provided in the present application can be directly sutured with the valve leaflets to form a complete valve and implanted in the body, or it can be used as an independent valve frame with another valve placed inside.

[0094] Residual pulmonary regurgitation (PR) is common after primary corrective surgery for complex congenital heart disease with oligopulmonary embolism (such as tetralogy of Fallot and pulmonary atresia). It is the most common long-term complication after such surgery, particularly when transannular patch repair is used. Severe PR can lead to right ventricular outflow tract (RVOT) aneurysmal dilatation and dysfunction, pulmonary artery aneurysmal dilatation, ventricular dyssynchrony and arrhythmias, progressive right ventricular dilatation / dysfunction, and subsequent right heart failure, ultimately leading to heart failure and death. The significance of pulmonary valve reconstruction has been increasingly recognized in recent years. Traditional surgical pulmonary valve replacement requires a second thoracotomy and is performed under extracorporeal circulation. Transcatheter pulmonary valve replacement (TPVR), a minimally invasive procedure that has gradually emerged since its initial description by Bonhoeffer et al. in 2000, offers an alternative to surgical pulmonary valve replacement and improves the long-term prognosis for these patients. Transcatheter pulmonary valve replacement (TPVR) uses a pulmonary valve stent for replacement. The pulmonary valve stent generally includes a stent to support the blood vessels and a valve to replace the original pulmonary valve. The valve is implanted into the pulmonary valve position through a percutaneous interventional procedure for valve replacement.

[0095] Transcatheter pulmonary valves can be deployed using either balloon expansion or self-expanding methods. Currently, most self-expanding valves are placed in a carrier catheter and implanted percutaneously. Once the valve reaches its intended location, it is released and secured to the annulus using the structure of the valve support. However, balloon-expandable stents cannot automatically expand upon reaching their intended location; they must be expanded through the balloon and the interaction between the support struts of the valve support.

[0096] Based on the above problems, another embodiment of the present application provides a valve frame for a pulmonary valve. The valve frame 1 can not only meet the requirements of the pulmonary valve, but also can expand evenly and has good reliability in use.

[0097] As shown in Figure 1, another embodiment of the present application provides a valve frame 1 for a pulmonary valve, comprising a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is constructed into a hollow tubular structure according to the requirements of use, and can be a structure with a circular axial cross-section. The hollow channel inside the frame body 11 is used for blood flow. Of course, it is understandable that the frame body 11 can also be constructed into other shapes such as hexagons or octagons according to the requirements of use. In order to achieve the supporting function, the frame body 11 is configured to include a plurality of lattice structures 14. After being expanded, each lattice structure 14 can form a larger support surface, thereby achieving the function of supporting the internal tissue of the implanted blood vessel.

[0098] As shown in Figures 5 and 8, the distal body 13 is configured as a plurality of unit bodies 130 with an "M"-shaped outline. Each unit body 130 is connected end to end to form a closed structure, and each unit body 130 is connected to the frame body 11 (see Figure 1). In this configuration, during the expansion of the valve frame 1 as a whole, the "M"-shaped unit body 130 can achieve the pulling of each connection point and the self-constraint of shape deformation during expansion. At the same time, combined with the pulling and restraining effects of each cellular structure 14 during expansion, the entire valve frame 1 can be expanded uniformly, with good overall shape consistency, which well meets the use requirements of the valve frame 1. The unit body has an "M"-shaped outline, which is the shape presented when the distal body 13 of the valve frame 1 is placed vertically upward. If the distal body 13 of the valve frame 1 is placed vertically downward, the shape presented is "W". That is, according to different placement methods, the intuitive shape of the unit body may vary. For ease of understanding, in the embodiment of the present application, the distal end body 13 of the valve frame 1 is placed vertically upward, and the unit body is described as being in an "M" shape.

[0099] Because there are several branching blood vessels near the pulmonary valve, the distal end of the valve frame 1 needs to be designed to be relatively sparse to avoid clogging the branch vessels. In this embodiment, the number of unit cells 130 is set to m, where m is a natural number greater than or equal to 2. For example, different numbers of unit cells 130, such as 2, 3, 4, or 5, can achieve different support areas. For example, a larger value of m increases the number of unit cells 130 and reduces the mesh size of the valve frame 1. Conversely, a smaller value of m reduces the number of unit cells 130 and reduces the mesh size of the valve frame 1. Therefore, the specific number of unit cells 130 can be set according to different application scenarios.

[0100] It should be noted that the distal body of the embodiment of the present application can be composed of m "M" unit bodies, or can be composed of m "M" unit bodies and other shapes, and the other shapes include but are not limited to "V" shape.

[0101] In some possible embodiments, the valve stent 1 used in the pulmonary valve of the embodiment of the present application is a balloon-expandable valve stent. A balloon is placed inside the stent. By inflating the balloon or adding liquid to the balloon, the balloon gradually expands. The valve stent 1 expands outward with the help of the force generated by the balloon expansion. During the expansion process, the various connection points can pull on each other and self-constrain the shape deformation during expansion, so that the force can be evenly applied to all parts and deform synchronously, thereby achieving the effect of uniform expansion, avoiding the problem of uneven expansion in certain parts that cannot effectively support the blood vessels. The expanded valve stent 1 has a uniform shape and good consistency, which improves the reliability of the valve stent 1.

[0102] In an embodiment of the present application, a pulmonary valve stent 1 is provided. The distal body 13 is configured as a plurality of unit bodies 130 with an "M"-shaped profile. A plurality of cellular structures 14 are provided on the stent body 11, and each unit body 130 is connected to the stent body 11. With this configuration, during expansion of the stent 1, the "M"-shaped unit bodies 130 can pull at each connection point and constrain the expansion path. Combined with the pulling and restraining effects of the cellular structures 14 during expansion, synchronized expansion is achieved, allowing the entire stent 1 to expand evenly and maintain a consistent overall shape.

[0103] The petal frame 1 provided in the embodiment of the present application has a total of 18-24 support rods 143 on the frame body 11 and along the circumferential direction of the frame body 11 , surrounding each lattice structure 14 at the same position.

[0104] It should be noted that the unit body 130 of the present embodiment includes a first support body 131 and a second support body 132 connected at one end. The connected end of the first support body 131 and the second support body 132 is connected to the frame body 11. Specifically, the unit body 130 is constructed by connecting the first support body 131 and the second support body 132 according to a predetermined shape. The unit body 130 has an "M"-shaped profile with two sawtooth-like tips. The heights of the two tips can be the same or different. The first support body 131 and the second support body 132 can be a single rod-shaped member bent into the "M"-shaped unit body 130, or they can be formed by connecting different rod-shaped members. The interiors of the two tips are through-holes for blood to pass through. Of course, it is understood that, as long as the unit body 130 maintains an "M"-shaped profile and the coverage rate of the valve frame 1 meets reasonable usage requirements, the number of first support bodies 131 and / or second support bodies 132 and the shape formed by their combination are not limited herein.

[0105] In the embodiment of the present application, one end of the first support body 131 and the second support body 132 connected to the adjacent wave crest 141 of the cellular structure 14 is connected. In this way, during expansion, the first support body 131 and the second support body 132 can generate a pulling force in the axial direction, thereby achieving mutual pulling between the connected cellular structure 14, the first support body 131 and the second support body 132, guiding the expansion deformation and further improving the uniformity of expansion.

[0106] As shown in Figures 5 and 9, in the embodiment of the present application, a "W"-shaped opening 1301 is formed between two adjacent unit bodies 130, and the ratio of the area of ​​a single opening 1301 to the area formed by the distal body 13 and the openings 1301 is ≥10%. Specifically, the "W"-shaped opening 1301 formed between two adjacent unit bodies 130 refers to the area of ​​the opening 1301 formed between the first support 131 of the first unit body 130 and the first support 131 of the adjacent unit body 130 when the distal body 13 of the valve frame 1 is placed vertically upward. This area also includes the second support 132 of the first unit body 130, so that the overall outline of the opening 1301 area formed by the combination is generally "W"-shaped. It is defined that the area formed by the distal body 13 and the multiple openings 1301 is ≥10% of the area of ​​the area formed by the combination of the distal body 13 and the multiple openings 1301. Such an arrangement not only ensures that the overall support strength of the valve frame 1 is within an appropriate range, but also reduces the overall material usage of the distal body 13 and provides an appropriate coverage rate.

[0107] As shown in Figures 5 to 8, the height of the peak n2 of the second support body 132 is less than or equal to 2 / 3 of the height of the peak n1 of the first support body 131 adjacent to it on both sides. Furthermore, the height of the peak n2 of the second support body 132 is less than or equal to 1 / 2 of the height of the peak n1 of the first support body 131 adjacent to it on both sides. The lower the height of the peak n2, the larger the "W"-shaped opening 1301, which is more conducive to avoiding blocking the branch vessels of the distal pulmonary artery, thereby effectively preventing blockage of the branch vessels. Of course, the height relationship between the peaks n1 and n2 can also be within other ranges, provided that the requirements for use are met.

[0108] As shown in Figures 8 and 9 , in the valve frame 1 provided by the above technical solution, the area of ​​the peak n2 in the middle of the "W"-shaped opening 1301 is less than or equal to 1 / 3 of the area of ​​the adjacent peaks n1 on either side. Furthermore, the area of ​​the peak n2 in the middle of the "W"-shaped opening 1301 is less than or equal to 1 / 4 of the area of ​​the adjacent peaks n1 on either side. The coverage area of ​​the peak n1 cannot be too small, as it will not be easily expanded evenly by the balloon. However, if the coverage area of ​​the peak n1 is too large, the height of the "W"-shaped opening 1301 may be too small, which may easily cause the pulmonary artery to block the opening 1301 of the branch vessel.

[0109] According to the petal frame 1 provided by the above technical solution, the width of the first support body 131 is 1.0-3.5 times the width of the second support body 132, and / or the thickness of the first support body 131 is 1.0-3.5 times the thickness of the second support body 132. Furthermore, the width of the first support body 131 is 1.3-3 times the width of the second support body 132, and / or the thickness of the first support body 131 is 1.3-3 times the thickness of the second support body 132; furthermore, the width of the first support body 131 is 1.5-2.5 times the width of the second support body 132, and / or the thickness of the first support body 131 is 1.5-2.5 times the thickness of the second support body 132. In some embodiments of the present invention, the radial or axial support force of the wave peak n1 can be increased by increasing the width of the first support body 131. In other embodiments of the present invention, the radial or axial support force of the wave peak n1 can be increased by increasing the thickness of the first support body 131. In still other embodiments of the present invention, the radial or axial support force of the wave peak n1 can be increased by simultaneously increasing the width and thickness of the first support body 131. In the embodiment of the present application, the width of the support rod 143 of the frame body 11 is set to 0.15-0.5mm, preferably 0.18-0.4mm; the thickness is set to 0.15-0.40mm, preferably 0.18-0.35mm.

[0110] As shown in the aforementioned embodiments, the pulmonary valve frame of the present application includes a reinforcement member, as shown in Figures 8 and 9. Based on the reinforcement member 133 provided by the aforementioned technical solution, provided that the valve frame 1 meets usage requirements such as coverage and overall weight, the number of reinforcement members 133 connected to each first support body 131 can be more than one, and the number required can be adjusted based on support requirements. The shape of the reinforcement member 133 can be configured in any shape, such as a bend or fold, as long as it provides sufficient deformation margin during expansion. When a reinforcement member 133 is connected to each first support body 131, the two ends of the reinforcement member 133 are respectively connected to the two side bars of the wave peak n1 formed by the bending of the first support body 131, and the position where the reinforcement member 133 is connected to the side bar is located at the midpoint of the side bar's length, or at any position between the midpoint and the peak of the wave peak n1. This arrangement not only provides reliable support for the first support body 131, but also places the reinforcement 133 closer to the apex of the wave crest n1, thereby increasing the area of ​​the hole formed between the reinforcement 133 and the frame 11. This hole is closer to the branch vessels of the pulmonary artery, reducing the obstruction caused by the reinforcement 133 and facilitating blood flow.

[0111] As shown in Figures 5 and 8, in the embodiment of the present application, a reinforcement member 133 is connected to each of the first supports 131 on the distal body 13. If there are three first supports 131, then three reinforcement members 133 are also provided. Furthermore, the two ends of the reinforcement member 133 are connected to the two side bars formed by bending the first support 131. Furthermore, a bend 1330 is formed on the reinforcement member 133, which is used to connect with an adjacent crest 141 on the frame 11. The adjacent crest 141 refers to the crest 141 in the lattice structure 14 on the frame 11 that is shortest from the bend 1330. Connecting the bend 1330 with the adjacent crest 141 not only further enhances the support for the first supports 131, but also allows the reinforcement member 133 and the lattice structure 14 to pull against each other during expansion, generating a mutual force that promotes uniform expansion.

[0112] In the pulmonary valve stent 1 provided by the above technical solution, the sum of the surface areas of the first supports 131 as a percentage of the surface area of ​​the cylinder formed by the unit bodies 130 is ≤ 2.5%; and the sum of the surface areas of the reinforcement members 133 as a percentage of the surface area of ​​the cylinder formed by the unit bodies 130 is ≤ 2.0%. The surface area refers to the total surface area of ​​an object; for example, the surface area of ​​the first supports 131 refers to the total surface area of ​​the first supports 131. Furthermore, the percentage of the total surface area of ​​each first support body 131 to the surface area of ​​the cylinder formed by the unit bodies 130 is ≤2.3%; the percentage of the total surface area of ​​each reinforcement member 133 to the surface area of ​​the cylinder formed by the unit bodies 130 is ≤1.8%; furthermore, the percentage of the total surface area of ​​each first support body 131 to the surface area of ​​the cylinder formed by the unit bodies 130 is ≤2.0%; the percentage of the total surface area of ​​each reinforcement member 133 to the surface area of ​​the cylinder formed by the unit bodies 130 is ≤1.5%. The ratio of the total surface area of ​​each first support body 131 to the surface area of ​​the cylinder formed by the unit bodies 130 will directly affect the axial and radial support force of the distal body 13, resulting in the distal body 13 of the valve frame 1 not being well fixed in the surrounding tissue, thereby affecting the fixation effect of the valve frame 1. The ratio of the combined surface area of ​​each reinforcement member 133 to the surface area of ​​the cylinder formed by the unit cells 130 will affect the uniformity of expansion of each unit cell 130 and even the valve frame 1, ultimately affecting the performance of the entire valve frame 1. Therefore, arranging the structures of each first support body 131 and each reinforcement member 133 within a reasonable range can improve the overall reliability of the valve frame 1.

[0113] In some possible embodiments, as shown in FIG8 , the angle β1 formed by the bending of the first support 131 is [40°, 110°] and / or the angle β2 formed by the bending of the second support 132 is [40°, 179°]. Specifically, the angle β1 formed by the bending of the first support 131 not only affects the strength of the support, but also affects the shape of the formed tip, thereby affecting the reliability of the tip's positioning within the tissue. Therefore, optionally, setting the angle β1 formed by the bending of the first support 131 to [40°, 110°] can better meet the requirements of use. Furthermore, the angle β1 formed by the bending of the first support 131 is [50°, 100°], and further, the angle β1 formed by the bending of the first support 131 is [60°, 90°]. The size of the angle β2 formed by the bending of the second support body 132 will affect the uniformity of the expansion of the valve frame 1 under the action of the balloon. If the angle is too large, it will be detrimental to the expansion of the wave peak n1 and the support rod 143 axially connected thereto, thereby causing the entire valve frame 1 to expand unevenly and fail to provide effective support to the tissue. Therefore, optionally, the size of the angle β2 formed by the bending of the second support body 132 is set to [40°, 179°]; further, the size of the angle β2 formed by the bending of the second support body 132 is [50°, 170°]; further, the size of the angle β2 formed by the bending of the second support body 132 is [60°, 160°]. It should be noted that β1 and β2 may be the same or different.

[0114] Furthermore, as shown in Figure 1, the valve frame 1 provided in the embodiment of the present application has two ends, namely the proximal body 12 and the distal body 13, whose diameters are slightly larger than the diameter of the frame body 11, forming a waist drum-shaped structure, and the diameter gradually decreases from the end to the middle waist 112, thereby further improving the fixing effect of the valve frame 1 and avoiding displacement.

[0115] As shown in Figure 1, according to the valve frame 1 provided by the above technical solution, the ratio of the maximum diameter of the proximal body 12 and / or the distal body 13 of the valve frame 1 to the minimum diameter of the frame body 11 is (1, 1.8]:1. Furthermore, the ratio of the maximum diameter of the proximal body 12 and / or the distal body 13 to the minimum diameter of the frame body 11 is [1.1, 1.5]:1; further, the ratio of the maximum diameter of the proximal body 12 and / or the distal body 13 to the minimum diameter of the frame body 11 is [1.1, 1.4]:1.

[0116] In some possible embodiments, as shown in Figure 1 , the valve holder 1 provided according to the above technical solution comprises a waist portion 112 of uniform diameter, and a connecting portion 113 extending from the edge of waist portion 112 toward the proximal body 12 and / or distal body 13, with gradually increasing diameters. The proximal body 12 and distal body 13 are respectively connected to corresponding connecting portions. Because the diameters of the proximal body 12 and distal body 13 are designed to differ from the diameter of the valve holder 11 based on usage requirements, the smoothness of the overall structure of the valve holder 1 is ensured by the filtering connection provided by the connecting portion 113.

[0117] As shown in Figure 1 , the valve frame 1 provided by the above-described technical solution has a waist portion 112 of 15%-60% of the total length of the valve frame 1. Furthermore, the waist portion 112 of the valve frame 1 can be 20%-40% of the total length of the valve frame 1. While the total length of the valve frame 1 remains constant, varying waist portion 112 lengths will result in variations in the lengths of the proximal body 12, distal body 13, and connecting portion 113. A longer waist portion 112 shortens the connecting portion 113, resulting in a greater angle of inclination from the waist portion 112 toward the ends of the valve frame 1. Conversely, a shorter waist portion 112 lengthens the connecting portion 113, resulting in a smaller angle of inclination from the waist portion 112 toward the ends of the valve frame 1. This allows the valve frame 1 to have different configurations and a wide range of applications. In the present embodiment, the waist portion 112 length is designed within the aforementioned range to meet various design requirements.

[0118] As shown in Figure 1, according to the valve frame 1 provided by the above technical solution, the angle between the line connecting the apex of the distal body 13 and the midpoint of the waist 112 and the central axis of the frame body 1 is α3, and the angle between the line connecting the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 1 is α4. The size of α3 or α4 is between (0°, 30°], where α3 = α4, or α1 ≠ α2, or α3 is less than α4. It can be understood that the angles α3 and α4 between the line connecting the apex of the proximal body 12 / distal body 13 and the midpoint of the waist 112 and the central axis of the frame body 1 are the angles between the line connecting the apex of the proximal body 12 / distal body 13 and the midpoint of the waist 11 and the central axis of the frame body 11.

[0119] As previously described, the proximal body 12 is connected to the crests 141 of the cellular structure 14 via the second connecting rod 15. Specifically, the second connecting rod 15 connects the proximal body 12 to the opposing crests 141. The provision of the second connecting rod 15 increases the overall length of the proximal body 12, thereby making it easier for the proximal body 12 to swell, expanding into a cylindrical or outward-turned trumpet shape, thereby improving the reliability of its positioning within the implanted tissue.

[0120] Furthermore, the length of the second connecting rod 15 is 0.8 mm to 4 mm; or the length of the second connecting rod 15 is 1.5 mm to 3.5 mm. According to design requirements, the second connecting rod 15 can be set to different lengths within this range, so that the proximal body 12 can be constructed into different specifications and shapes, with a wide range of applications.

[0121] According to the valve frame 1 provided by the above technical solution, the polygons formed on the distal body 13 and the proximal body 12 are irregular polygons. In some embodiments of the present application, due to the design of the patterned structure of the valve frame 1, the wavy structure of the proximal body 12 or the distal body 13, when the force applied by the balloon is consistent, naturally forms an irregular polygon. In other embodiments of the present application, the wavy structure of the proximal body 12 or the distal body 13 is designed as a regular polygon, but the outward force applied by the balloon to the proximal body 12 or the distal body 13 varies at different locations, resulting in an irregular polygon shape. In some other embodiments, the polygons formed by the wavy structure of the distal body 13 or the proximal body 12 are non-planar polygons, with certain folds and curves, forming a structure with a certain three-dimensional shape.

[0122] In some possible embodiments, the pulmonary valve stent 1 provided herein has a radial support force of [6kPa, 140kPa] for the stent body 11, or [12kPa, 100kPa] for the stent body 11; a radial support force of [6kPa, 120kPa] for the proximal body 12, and a radial support force of [6kPa, 100kPa] for the distal body 13, with the deformation resistance of the distal body 13 being greater than or equal to 1.5N. The stent 1 is configured to have a radial support force within the aforementioned numerical range, so that the support force ensures that the stent 1 is easily positioned on the valve annulus and the leaflets are not easily washed away by the blood flow, while also preventing excessive radial support force from hindering valve compression for delivery and preventing deformation that could damage the valve annulus and aorta. The stent 1 has a support force performance within the aforementioned numerical range, which satisfies usage requirements and provides good reliability.

[0123] The valve holder 1 provided in the embodiment of the present application has a deformation resistance of the distal body 13 greater than or equal to 0.5N (deformation resistance refers to the force required to cause irreversible deformation of the distal body 13 during continuous compression). This deformation resistance within this numerical range provides the distal body 13 with excellent axial support performance and compressive resistance that meets usage requirements. This reduces the risk of damage caused by irreversible deformation of the distal body 13 under axial pressure, such as changes in the axial support position, resulting in a poor or failed support effect, or the creation of protrusions or sharp points directed toward tissue, which can puncture the tissue, and other uncontrollable adverse effects. This significantly improves the safety and reliability of the valve holder 1.

[0124] According to the above technical solution, the valve frame 1 provided by the base material of the valve frame 1 has a yield strength of 350-1450 MPa and / or a tensile strength of 400-1500 MPa. The base material of the valve frame 1 used in this application has a good yield strength or tensile strength, thereby ensuring that the valve frame 1 has a minimal diameter and material requirements while still maintaining a corresponding radial support force. This facilitates in vivo delivery of the valve frame 1. When the base material of the valve frame 1 is a degradable valve frame 1, the reduced material requirements reduce the burden of degradation / absorption in the body.

[0125] According to the above technical solution, the base material of the valve frame 1 has an elongation of greater than or equal to 5%. The base material of the valve frame 1 used in this application has a good elongation, so the valve frame 1 has good delivery performance in the body. In addition, the valve frame 1 also has better plasticity and is not easy to break.

[0126] The material of the valve frame 1 for the degradable pulmonary valve provided in the embodiment of the present application can be completely non-degradable, completely degradable, or partially degradable. When it is at least partially degradable, the material of the degradable part can be at least one of metal or non-metal; wherein the metal includes at least any one of pure iron, iron alloy, pure magnesium, magnesium alloy, pure zinc or zinc alloy; the non-metal includes at least any one of degradable polyester, degradable polyanhydride and binary or multi-component degradable copolymers copolymerized with the corresponding monomers, and the degradable polyester includes polylactic acid, polyglycolic acid, polylactic glycolic acid, polycaprolactone, polylactide, polyglycolide, polycaprolactone, polyhydroxyalkanoate, polyacrylate, polysuccinate, poly(β-hydroxybutyrate), polyethylene adipate, etc. at least one of an alcohol ester, a polyhydroxybutyrate valerate copolymer; a degradable polyanhydride including at least one of poly 1,3-bis(p-carboxyphenoxy)propane-sebacic acid, polyerucic acid dimer-sebacic acid or polyfumaric acid-sebacic acid; or a non-metal including at least one of a degradable polyamino acid and a degradable tyrosine-derived polymer, the degradable polyamino acid including at least one of polyglycine, polyalanine, polyvaline, polyleucine, polyisoleucine, polymethionine, polyproline, polytryptophan, polyserine, polytyrosine, polycysteine, polyphenylalanine, polyasparagine, polyglutamine, polythreonine, polyarginine, polyhistidine, polyselenocysteine, polypyrroline, polyglutamic acid, polyaspartic acid, polyornithine, polylysine and derivatives thereof;Degradable tyrosine-derived polymers include methyl (2R)-2-amino-3-(2-chloro-4-hydroxyphenyl) propionate, D-tyrosine ethyl ester hydrochloride, methyl (2R)-2-amino-3-(2,6-dichloro-3,4-dimethoxyphenyl) propionate HD-Tyr(TBU)-allyl ester HCl, methyl (2R)-2-amino-3-(3-chloro-4,5-dimethoxyphenyl) propionate, methyl (2R)-2-amino-3-(2-chloro-3-hydroxy-4-methoxyphenyl) propionate, methyl (2R)-2-amino-3-(4-[(2-chloro-6-fluorophenyl)methoxy]phenyl) propionate, methyl (2R)-2-amino-3-(2-chloro- 3,4-dimethoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(3-chloro-5-fluoro-4-hydroxyphenyl)propionic acid methyl ester, 2-(acetylamino)-2-(4-[(2-chloro-6-fluorobenzyl)oxy]benzylmalonate, (2R)-2-amino-3-(3-chloro-4-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(3-chloro-4-hydroxy-5-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(2,6-dichloro-3-hydroxy-4-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(3-chloro-4-hydroxyphenyl)propionic acid methyl ester, H-DL-tyr-OME HCl, H-3,5-diiodo-tyr-OME HCl, HD-3,5-diiodo-tyr-OME HCl, HD-tyr-OMEHCl, D-tyrosine methyl ester hydrochloride, D-tyrosine-ome HCl, D-tyrosine methyl ester hydrochloride, HD-tyr-OMe HCl, D-tyrosine methyl ester HCl, HD-Tyr-OMe-HCl, (2R)-2-amino-3-(4-hydroxyphenyl)propionic acid, (2R)-2-amino-3-(4-hydroxyphenyl)propionic acid methyl ester hydrochloride, (2R)-2-amino-3-(4-hydroxyphenyl)propionic acid methyl ester hydrochloride, (2R)-2-azanyl-3-(4-hydroxyphenyl)propionic acid methyl ester hydrochloride, 3-chloro-L-tyrosine, 3-nitro-L-tyrosine, 3-nitro-L-tyrosine ethyl ester hydrochloride, DL-m-tyrosine, DL-o-tyrosine, Boc-Tyr(3,5-I2)-OSu, Fmoc-tyr(3-NO2)-OH, α-methyl-L-tyrosine, α-methyl-D-tyrosine, and α-methyl-DL-tyrosine.

[0127] It should be noted that pure metal in the embodiments of the present application refers to metals in which the total content of other impurities is less than or equal to 0.5 wt.%. For example, pure iron refers to metals in which the total content of other metals and / or non-metals other than iron is less than or equal to 0.5 wt.%.

[0128] The valve frame 1 provided in the present invention can be directly sutured with the valve leaflets to form a complete valve and implanted in the body, or it can be used as an independent valve frame 1 with another valve leaflet placed inside.

[0129] The present application also provides a pulmonary valve in an embodiment, comprising leaflets and the aforementioned valve frame 1, wherein the leaflets are connected to the valve frame 1. The pulmonary valve utilizes the aforementioned valve frame 1, which is not only capable of uniform expansion but also has an appropriate radial support force, the magnitude of which ensures that the valve frame 1 is easily positioned on the valve annulus and prevents the leaflets from being washed away by blood flow, thereby greatly improving the reliability of the pulmonary valve.

[0130] It should be noted that, in some embodiments, the degradable valve frame of the above-mentioned embodiments can be applied to the valve frame for the pulmonary valve. It can be understood that the structure, parameters, and effects described about the above-mentioned degradable valve frame 1 can be combined with the valve frame for the pulmonary valve, that is, the structure that is not specifically described in the structure appearing in the valve frame for the pulmonary valve can be replaced with the structure of the degradable valve frame of the above-mentioned embodiments.

[0131] All data in this application refer to the corresponding values ​​of the middle portion of the valve frame 1 at the nominal diameter. The "nominal diameter" refers to the diameter of the middle portion of the valve frame 1 when the valve frame 1 is fully expanded at the nominal pressure, while the nominal diameter refers to the diameter of the valve frame 1 when fully expanded at the nominal pressure. The nominal pressure refers to the pressure required to fully expand the valve frame 1 clinically; fully expanded refers to the state when the valve frame 1 is expanded to match the diameter of the lumen in which it is used.

[0132] The range of values ​​between X1 and X2 in this application indicates that the range can be X1, X2, or any value within the range between X1 and X2, i.e., the range is a closed interval. For example, if this application mentions "the wall thickness of the stent is 0.04 mm to 0.5 mm," the stent wall thickness can be 0.04 mm, 0.5 mm, or any value between 0.04 and 0.5 mm.

[0133] In order to facilitate understanding of the present application, the following describes the key points of the present application in conjunction with some specific embodiments. It is understood that the relevant embodiments are only some examples of the present application and do not constitute a limitation on the scope of application.

[0134] Example 1

[0135] The present embodiment provides a degradable valve frame 1, which is made of nitrided iron with a tensile strength of 850 MPa and a yield strength of 750 MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is formed by connecting a plurality of lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods, with a wall thickness of 0.23 mm and a coverage rate of 6.6%; the coverage rate of the distal body 13 is 2.5%. The valve frame 1 is a fully closed design with an angle α1 of 50° and an angle α2 of 40°. The distal body 13 is directly connected to the frame body 11, and the proximal body 12 is connected to the frame body 11 through a second connecting rod 15 with a length of 4.0 mm. The frame 11 accounts for 15% of the total length of the valve frame. The frame 1 is tilted at both ends. The diameter of the frame 11 is 20 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the frame 11 is 1.2. The angle between the line connecting the vertex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is α3, and the angle between the line connecting the vertex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is α4. Both α3 and α4 are 8°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are installed on the two side bars formed by the bending of the first support 131. The reinforcements 133 are connected to the midpoints of the length of the two side bars.

[0136] The valve frame has a radial support force of 18kPa, an axial deformation resistance of 3.5N, and an anti-parallel plate extrusion force of 0.2N / mm; it can be implanted into the pulmonary valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly, the expansion of the valve frame was not restricted, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the first implanted valve frame had undergone obvious degradation; the re-implanted valve frame completely degraded in about three years.

[0137] Example 2

[0138] This embodiment provides a degradable valve frame 1 made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is formed by connecting multiple lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods. The support rod wall thickness is 0.18 mm, the coverage rate is 7.1%, and the coverage rate of the distal body 13 is 2.8%. The valve frame 1 is a fully closed design, with an angle α1 of 60° and an α2 of 50°. The distal body 13 is directly connected to the frame body 11, and the proximal body 12 is connected to the frame body 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 75% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 20 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.1. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 5°, while the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 0°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the length of each side bar.

[0139] The valve stent has a radial support force of 30kPa, an axial deformation resistance of 2.1N, and an anti-parallel plate extrusion force of 0.16N / mm; it can be implanted into the dog's aortic valve through an interventional method. The stent can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve stent was implanted in situ. The implantation process went smoothly. During expansion, the valve stent was not constrained by the original stent, and the blood vessel could still be expanded to the expected diameter. After that, the valve stent was removed, and it can be seen that the first implanted valve stent had undergone obvious degradation, and the re-implanted valve stent was completely degraded in about three years.

[0140] Example 3

[0141] This embodiment provides a degradable valve frame 1, specifically a zinc-based absorbable mitral valve stent. The material is zinc alloy with a tensile strength of 480 MPa and a yield strength of 380 MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of multiple interconnected cellular structures, each of which is formed by a combination of 36 support rods in the same circumferential direction. The support rod wall thickness is 0.15 mm, with a coverage rate of 9.2%. The distal body 13 has a coverage rate of 3.8%. The valve frame 1 has a fully closed design, with an angle α1 of 120° and an α2 of 65°. The distal body 13 is directly connected to the frame body 11, while the proximal body 12 is connected to the frame body 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 65% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.3. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 13°, while the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 0°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the length of each side bar.

[0142] The valve frame has a radial support force of 12kPa, an axial deformation resistance of 1.2N, and an anti-parallel plate extrusion force of 0.10N / mm; it can be implanted into the dog's mitral valve through an interventional method, and the valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly, and the valve frame was not constrained by the original stent during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the first implanted valve frame had undergone obvious degradation, and the re-implanted valve frame was completely degraded in about three years.

[0143] Example 4

[0144] This embodiment provides a biodegradable valve frame 1, specifically an iron-based absorbable tricuspid valve stent, made of nitrided iron with a tensile strength of 900 MPa and a yield strength of 830 MPa. The biodegradable valve frame 1 includes a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is formed by connecting multiple lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods. The support rod wall thickness is 0.15 mm, the coverage rate is 8.0%, and the coverage rate of the distal body 13 is 2.4%. The stent has a fully closed design, with an angle α1 of 160° and an α2 of 175°. The distal body 13 is directly connected to the frame body 11, and the proximal body 12 is connected to the frame body 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 75% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 18 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.8. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 30°, while the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 0°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the length of each side bar.

[0145] The valve frame has a radial support force of 40kPa, an axial deformation resistance of 1.8N, and an anti-parallel plate extrusion force of 0.18N / mm; it can be implanted into the tricuspid valve of a dog through an interventional method, and the valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second stent was implanted in situ, and the implantation process went smoothly. During expansion, the valve frame was not constrained by the original stent, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it could be seen that the first implanted valve frame had undergone obvious degradation, and the second implanted valve frame was completely degraded in about three years.

[0146] Example 5

[0147] This embodiment provides a biodegradable valve stent 1, specifically an iron-based absorbable pulmonary valve stent, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The biodegradable valve stent 1 includes a frame 11, a proximal body 12, and a distal body 13. The frame 11 is formed by connecting multiple lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods. The support rod wall thickness is 0.35 mm, the coverage rate is 13%, and the coverage rate of the distal body 13 is 5.5%. The stent has a fully closed design, with an angle α1 of 100° and an α2 of 90°. The distal body 13 is directly connected to the frame 11, and the proximal body 12 is connected to the frame 11 via a second connecting rod 15 with a length of 1.5 mm. The frame 11 accounts for 20% of the total length of the valve frame. The frame 1 is tilted at both ends. The diameter of the frame 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the frame 11 is 1.3. The angle between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is α3, and the angle between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is α4. Both α3 and α4 are 9°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131. The reinforcements 133 are connected to the midpoints of the length of the two side bars.

[0148] The radial support force of the valve frame 1 is 80kPa, the axial deformation is 5.0N, and the anti-parallel plate extrusion force is 0.5N / mm; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method. The valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of the distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly. The valve frame was not constrained by the original stent during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the valve frame implanted for the first time had obviously degraded, and the valve frame implanted again was completely degraded in about four years.

[0149] Example 6

[0150] This embodiment provides a biodegradable valve stent 1, specifically an iron-based absorbable pulmonary valve stent, made of pure iron with a tensile strength of 650 MPa and a yield strength of 480 MPa. The biodegradable valve stent 1 includes a frame 11, a proximal body 12, and a distal body 13. The frame 11 is formed by connecting multiple lattice structures, each of which is formed by a total of 36 support rods in the same circumferential direction. The support rod wall thickness is 0.25 mm, with a coverage rate of 5.0%. The distal body 13 has a coverage rate of 2.1%. The stent has a fully closed design, with angles α1 of 90° and α2 of 75°. The distal body 13 is directly connected to the frame 11, and the proximal body 12 is connected to the frame 11 via a second connecting rod 15 with a length of 1.5 mm. The frame 11 accounts for 20% of the total length of the valve frame. The frame 1 is tilted at both ends. The diameter of the frame 11 is 24 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the frame 11 is 1.3. The angle between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is α3, and the angle between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is α4. Both α3 and α4 are 9°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a crest n1, and the second support 132 is bent to form a crest n2. The height of crest n2 is 1 / 3 of that of crest n1. Reinforcements 133 are installed on the two side bars formed by the bending of the first support 131. These reinforcements 133 are connected between the midpoints of the two side bars and crest n1, respectively, ensuring reliable support.

[0151] The valve frame has a radial support force of 6kPa, an axial deformation resistance of 2.5N, and an anti-parallel plate extrusion force of 0.12N / mm; it can be implanted into the dog's pulmonary valve through an interventional method, and the valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly, and the valve frame was not constrained by the original valve frame during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the first implanted valve frame had undergone obvious degradation, and the second implanted valve frame was completely degraded after about three and a half years.

[0152] Example 7

[0153] This embodiment provides a biodegradable valve stent 1, specifically an iron-based absorbable aortic valve stent. The stent is made of an iron-manganese alloy with a tensile strength of 1500 MPa and a yield strength of 1450 MPa. The biodegradable valve stent 1 comprises a frame 11, a proximal body 12, and a distal body 13. The frame 11 is composed of a plurality of interconnected cellular structures, each of which is formed by a total of 48 struts arranged in the same circumferential direction. The struts have a wall thickness of 0.40 mm and a coverage ratio of 18%. The distal body 13 has a coverage ratio of 6%. The stent has a fully enclosed design, with angles α1 of 140° and α2 of 90°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 50% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.5. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 15°. The angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame midsection 11 and the central axis of the frame 11 is 0°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the length of each side bar.

[0154] The radial support force of the valve frame is 140kPa, the axial deformation resistance is 6.5N, and the anti-parallel plate extrusion force is 0.8N / mm; the valve frame can be implanted into the dog's aortic valve through an interventional method. The valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly. During the expansion of the valve frame, it was not constrained by the original valve frame, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the first implanted valve frame had undergone obvious degradation, and the re-implanted valve frame was completely degraded in about five years.

[0155] Example 8

[0156] This embodiment provides a biodegradable valve stent 1, specifically an iron-based absorbable aortic valve stent, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The biodegradable valve stent 1 includes a frame 11, a proximal body 12, and a distal body 13. The frame 11 is formed by connecting multiple lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods. The support rod wall thickness is 0.35 mm, the coverage rate is 15%, and the coverage rate of the distal body 13 is 5.8%. The stent has a fully closed design, with an angle α1 of 120° and an α2 of 90°. The distal body 13 is directly connected to the frame 11, and the proximal body 12 is connected to the frame 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 50% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.5. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 15°, while the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 0°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the two side bars along their lengths.

[0157] The valve frame has a radial support force of 120kPa, an axial deformation resistance of 5.2N, and an anti-parallel plate extrusion force of 0.6N / mm; it can be implanted into the dog's aortic valve through an interventional method, and the valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly, and the valve frame was not constrained by the original stent during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the first implanted valve frame had undergone obvious degradation, and the second implanted valve frame was completely degraded after about four and a half years.

[0158] Example 9

[0159] This embodiment provides a biodegradable valve stent 1, specifically an iron-based absorbable mitral valve stent, made of nitrided iron with a tensile strength of 800 MPa and a yield strength of 720 MPa. The biodegradable valve stent 1 comprises a frame 11, a proximal body 12, and a distal body 13. The frame 11 is formed by connecting multiple lattice structures, each of which is formed by a total of 36 support rods in the same circumferential direction. The support rod wall thickness is 0.35 mm, with a coverage rate of 13%, and the distal body 13 has a coverage rate of 5.5%. The stent has a fully closed design, with angles α1 of 110° and α2 of 90°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 35% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.3. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 9°, while the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 0°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the length of each side bar.

[0160] The radial support force of the valve frame 1 is 100kPa, the axial deformation is 5.1N, and the anti-parallel plate extrusion force is 0.5N / mm; the valve frame 1 can be implanted into the mitral valve of a dog through an interventional method. The valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of the distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly. The valve frame was not constrained by the original valve frame during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the valve frame implanted for the first time had undergone obvious degradation, and the valve frame implanted again was completely degraded in about four years.

[0161] Example 10

[0162] This embodiment provides a degradable valve frame 1, specifically an iron-based absorbable tricuspid valve stent, made of nitrided iron with a tensile strength of 900 MPa and a yield strength of 830 MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is formed by connecting multiple lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods. The support rod wall thickness is 0.38 mm, the coverage rate is 14%, and the coverage rate of the distal body 13 is 5.2%. The stent has a fully closed design, with an angle α1 of 70° and an α2 of 175°. The distal body 13 is directly connected to the frame body 11, and the proximal body 12 is connected to the frame body 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 75% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.8. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 30°, and the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 30°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the length of the two side bars.

[0163] The valve frame has a radial support force of 110kPa, an axial deformation resistance of 5.8N, and an anti-parallel plate extrusion force of 0.5N / mm; it can be implanted into the tricuspid valve of a dog through an interventional method, and the valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly, and the valve frame was not constrained by the original valve frame during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the first implanted valve frame had undergone obvious degradation, and the second implanted valve frame was completely degraded in about four and a half years.

[0164] Example 11

[0165] This embodiment provides a biodegradable valve stent 1, specifically an iron-based absorbable pulmonary valve stent, made of nitrided iron with a tensile strength of 750 MPa and a yield strength of 850 MPa. The biodegradable valve stent 1 comprises a body 11, a proximal body 12, and a distal body 13. The body 11 is formed by interconnecting multiple cellular structures, each of which is composed of a total of 12 struts arranged in the same circumferential direction, with a coverage ratio of 4.0%. Starting from the midpoint of the body 11, the wall thickness of the struts at the midpoint is 0.25 mm, gradually decreasing to 0.15 mm at each end, as it moves toward the proximal body 12 and distal body 13, respectively. The angle between the line connecting the vertex of the proximal body 12 or distal body 13 and the midpoint of the body 11 and the axis of the stent rod is 0.4°. The coverage ratio of the distal body 13 is 1.5%. The stent has a fully enclosed design, with angles α1 of 90° and α2 of 75°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 3.5 mm long. The frame 11 accounts for 20% of the total stent length. The stent 1 is tilted at both ends. The diameter of the frame 11 is 16 mm. The maximum diameter ratio of the proximal and distal bodies 12 and 13 to the frame 11 is 1.2. The angle between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is α3, and the angle between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is α4. Both α3 and α4 are 8°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, while the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131. These reinforcements 133 are connected to the midpoints of the lengthwise direction of the two side bars.

[0166] The valve frame has a radial support force of 12kPa, an axial deformation of 2.7N, and an anti-parallel plate extrusion force of 0.22N / mm; it can be implanted into the dog's pulmonary valve through an interventional method. The valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly. During expansion, the valve frame was not constrained by the original stent, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the first implanted valve frame had undergone obvious degradation, and the second implanted valve frame was completely degraded in about four years.

[0167] Example 12

[0168] This embodiment provides a biodegradable valve stent 1, specifically a magnesium-based absorbable pulmonary valve stent, with a tensile strength of 400 MPa and a yield strength of 350 MPa. The biodegradable valve stent 1 comprises a frame 11, a proximal body 12, and a distal body 13. The frame 11 and proximal body 12 are made of magnesium alloy, while the distal body 13 is made of a cobalt-chromium alloy and magnesium alloy. The magnesium alloy only constitutes a portion of the struts, primarily serving as a connector, accounting for 5% of the distal body. The remaining portion is made of cobalt-chromium alloy, with the distal portion accounting for 10%, meaning that the stent is 90.5% biodegradable. The frame 11 is composed of multiple interconnected cellular structures, each cellular structure in the same circumferential direction being composed of a total of 36 struts. The strut wall thickness is 0.23 mm, resulting in a coverage ratio of 6.2%, while the distal body 13 has a coverage ratio of 2.2%. The stent has a fully enclosed design, with angles α1 of 160° and α2 of 179°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 3.5 mm long. The frame 11 accounts for 20% of the total stent length. The stent 1 is tilted at both ends. The diameter of the frame 11 is 20 mm. The maximum diameter ratio of the proximal and distal bodies 12 and 13 to the frame 11 is 1.2. The angle between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is α3, and the angle between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is α4. Both α3 and α4 are 8°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, while the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131. These reinforcements 133 are connected to the midpoints of the lengthwise direction of the two side bars.

[0169] The valve frame has a radial support force of 10kPa, an axial deformation resistance of 1.8N, and an anti-parallel plate extrusion force of 0.1N / mm; it can be implanted into the pulmonary valve of a dog through an interventional method, and the valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of the distal branches. The non-degradable distal part of the valve frame is located at the opening of the pulmonary artery, has a large raised part, and can fit with the blood vessel wall; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly. During expansion, the valve frame was not constrained by the original valve frame, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the frame body 11 and the proximal body 12 of the valve frame 1 implanted for the first time have undergone obvious degradation, and the distal body 13 has also been completely deconstructed.

[0170] Example 13

[0171] The present embodiment provides a degradable valve frame 1, specifically a pulmonary valve stent, the main material of which is a non-degradable cobalt-chromium alloy with a tensile strength of 1500 MPa and a yield strength of 1450 MPa. The degradable valve frame 1 is formed by a combination of multiple support rods, including a frame body 11, a proximal body 12 and a distal body 13. Among them, the frame body 11 is formed by connecting a plurality of lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods, the support rod wall thickness is 0.23 mm, and the coverage rate is 6.6%. As shown in Figure 3, some of the support rods in the valve frame 1 are not continuous, and are connected by connecting rods 110 made of degradable polylactic acid material, and the rest are made of non-degradable cobalt-chromium alloy material. The area of ​​all connecting rods 110 accounts for 0.5% of the area of ​​the valve frame 1, that is, 0.5% of the valve frame 1 is degradable; the coverage rate of the distal body 13 is 2.5%. The stent has a fully enclosed design, with angles α1 of 90° and α2 of 75°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 3.5 mm long. The frame 11 accounts for 20% of the total stent length. The stent 1 is tilted at both ends. The diameter of the frame 11 is 20 mm, and the maximum diameter ratio of the proximal and distal bodies 12 and 13 to the frame 11 is 1.2. The angle α3 between the line connecting the vertex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 8°. The angle α4 between the line connecting the vertex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 8°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, while the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131. These reinforcements 133 are connected to the midpoints of the lengthwise direction of the two side bars.

[0172] The valve frame has a radial support force of 45kPa, an axial deformation resistance of 4.2N, and an anti-parallel plate extrusion force of 0.18N / mm; it can be implanted into the pulmonary valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly. The valve frame was not constrained by the original stent during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it can be seen that the connecting rod 110 in the first implanted valve frame 1 has degraded and the stent has been disassembled.

[0173] Example 14

[0174] This embodiment provides a biodegradable valve stent 1, specifically an iron-based absorbable pulmonary valve stent, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The biodegradable valve stent 1 includes a frame 11, a proximal body 12, and a distal body 13. The frame 11 is formed by connecting multiple lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods. The support rod wall thickness is 0.15 mm, with a coverage rate of 9%, and the distal body 13 has a coverage rate of 5%. The stent has a fully closed design, with an angle α1 of 110° and an α2 of 90°. The distal body 13 is directly connected to the frame 11, and the proximal body 12 is connected to the frame 11 via a second connecting rod 15 with a length of 1.5 mm. The frame 11 accounts for 20% of the total length of the valve frame. The frame 1 is tilted at both ends. The diameter of the frame 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the frame 11 is 1.3. The angle between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is α3, and the angle between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is α4. Both α3 and α4 are 8°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131. The reinforcements 133 are connected to the midpoints of the length of the two side bars.

[0175] The radial support force of the valve frame 1 is 65kPa, the axial deformation is 4.0N, and the anti-parallel plate extrusion force is 0.4N / mm; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method. The valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of the distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly. The valve frame was not constrained by the original stent during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it was found that the valve frame implanted for the first time had obviously degraded.

[0176] Example 15

[0177] This embodiment provides a degradable valve frame 1 made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is formed by connecting multiple lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods. The support rod wall thickness is 0.3 mm, the coverage rate is 5%, and the coverage rate of the distal body 13 is 2.1%. The valve frame 1 is a fully closed design, with an angle α1 of 70° and an α2 of 50°. The distal body 13 is directly connected to the frame body 11, and the proximal body 12 is connected to the frame body 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 75% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 20 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.1. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 10°, while the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 0°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the length of each side bar.

[0178] The valve stent has a radial support force of 50kPa, an axial deformation resistance of 3N, and an anti-parallel plate extrusion force of 0.23N / mm; it can be implanted into the aortic valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve stent was implanted in situ. The implantation process went smoothly. During expansion, the valve stent was not constrained by the original stent, and the blood vessel could still be expanded to the expected diameter. After that, the valve stent was removed, and it could be seen that the valve stent implanted for the first time had undergone obvious degradation.

[0179] Example 16

[0180] This embodiment provides a degradable valve frame 1, specifically an iron-based absorbable mitral valve stent, made of nitrided iron with a tensile strength of 900 MPa and a yield strength of 800 MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is formed by connecting multiple lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods. The support rod wall thickness is 0.18 mm, with a coverage rate of 5%, and the distal body 13 has a coverage rate of 2%. The valve frame 1 is a fully closed design, with an angle α1 of 100° and an α2 of 90°. The distal body 13 is directly connected to the frame body 11, and the proximal body 12 is connected to the frame body 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 50% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.3. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 8°, and the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 8°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the length of each side bar.

[0181] The valve frame has a radial support force of 30kPa, an axial deformation resistance of 1.8N, and an anti-parallel plate extrusion force of 0.18N / mm; it can be implanted into the dog's mitral valve through an interventional method. The valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly. During expansion, the valve frame was not constrained by the original stent, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it could be seen that the valve frame implanted for the first time had undergone obvious degradation.

[0182] Example 17

[0183] This embodiment provides a degradable valve frame 1, specifically an iron-based absorbable tricuspid valve stent, made of nitrided iron with a tensile strength of 900 MPa and a yield strength of 830 MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is formed by connecting multiple lattice structures, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods. The support rod wall thickness is 0.18 mm, the coverage rate is 5%, and the distal body 13 has a coverage rate of 2%. The stent has a fully closed design, with an angle α1 of 90° and an α2 of 85°. The distal body 13 is directly connected to the frame body 11, and the proximal body 12 is connected to the frame body 11 via a second connecting rod 15 with a length of 0.8 mm. The length of the frame 11 accounts for 60% of the total frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm, and the maximum diameter ratio of the distal body 13 to the frame 11 is 1.6. The angle α3 between the line connecting the apex of the distal body 13 and the midpoint of the frame 11 and the central axis of the frame 11 is 30°, and the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the frame 11 and the central axis of the frame 11 is 30°. The distal body 13 comprises a first support 131 and a second support 132. The first support 131 is bent to form a peak n1, and the second support 132 is bent to form a peak n2. The height of peak n2 is half that of peak n1. Reinforcements 133 are provided on the two side bars formed by the bending of the first support 131, and are connected to the midpoints of the length of each side bar.

[0184] The valve frame has a radial support force of 30kPa, an axial deformation resistance of 2N, and an anti-parallel plate extrusion force of 0.2N / mm; it can be implanted into the tricuspid valve of a dog through an interventional method. The valve frame can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of distal branches; at 12 months, a second valve frame was implanted in situ. The implantation process went smoothly. During expansion, the valve frame was not constrained by the original valve frame, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was removed, and it could be seen that the valve frame implanted for the first time had undergone obvious degradation.

[0185] Example 18

[0186] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve. The material is nitrided iron, with a tensile strength of 850 MPa and a yield strength of 750 MPa. The valve frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of multiple interconnected cellular structures, each cellular structure in the same circumferential direction being formed by 18 support rods with a wall thickness of 0.23 mm and a width of 0.25 mm. The distal body 13 comprises a first support body 131 and a second support body 132, forming three M-shaped unit bodies 130. A W-shaped opening 1301 is formed between adjacent unit bodies 130. The area ratio of a single opening 1301 to the area formed by the distal body 13 and the combined openings 1301 is 16%. Reinforcements 133 are provided. The height of peak n2 is half that of peak n1. The combined surface areas of the first support bodies 131 and the reinforcements 133 account for 1.3% and 1.2% of the cylindrical surface area enclosed by the unit bodies 130, respectively. The angle β1 of the first support body is 75°, and the angle β2 of the second support body is 90°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 3.5 mm long. The waist 112 accounts for 20% of the total length of the petal frame 1. The petal frame 1 is tilted at both ends. The frame 11 has a diameter of 20 mm. The maximum diameter ratio of the proximal and distal bodies 12 and 13 to the frame is 1.2. The angles α3 and α4 between the lines connecting the apex of the distal and proximal bodies 13 and the midpoint of the waist 112 and the central axis of the frame 11 are both 8°.

[0187] The radial support force of the scaffold 11 is 30 kPa, the radial support force of the proximal body 12 is 25 kPa, and the radial support force of the distal body 13 is 15 kPa. The axial deformation is 3.5 N. The scaffold 1 was implanted into the pulmonary valve of a dog through an interventional procedure. The scaffold 1 expanded evenly and was well fixed in the lumen without displacement, supporting the lumen without affecting blood flow in the distal branches. A second scaffold was implanted in situ at 12 months. The implantation went smoothly, with the scaffold expansion unrestricted and the vessel still able to expand to the desired diameter. Upon removal of the scaffold, significant degradation of the first implanted scaffold was observed.

[0188] Example 19

[0189] This embodiment provides an iron-based absorbable pulmonary valve frame 1, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of a plurality of interconnected cellular structures, each cellular structure in the same circumferential direction being formed by 12 struts. The struts have a wall thickness of 0.15 mm and a width of 0.35 mm. The distal body 13 comprises a first strut 131 and a second strut 132. The first strut 131 is partially widened by 1.5 times its width. The first and second struts 131 and 132 form two M-shaped unit cells 130. A W-shaped opening 1301 is formed between adjacent unit cells 130. The area ratio of a single opening 1301 to the combined area of ​​the distal body 13 and the openings 1301 is 25%. A reinforcement member 133 is also provided. The height of peak n2 is two-thirds of the height of peak n1. The combined surface area of ​​each first support 131 and the combined surface area of ​​each reinforcement member 133 account for 1.2% and 0.6%, respectively, of the cylindrical surface area enclosed by each unit body 130. The first support angle β1 is 110°, and the second support angle β2 is 160°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 1.5 mm long. The length of the waist 112 accounts for 60% of the total length of the petal frame 1. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are 1.8 and 1.4 respectively. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are 30° and 14° respectively.

[0190] The radial support force of the stent body 11 was 6 kPa, the radial support force of the proximal body 12 was 6 kPa, and the radial support force of the distal body 13 was 6 kPa, with an axial deformation of 1.8 N. The stent was implanted into the pulmonary valve of a dog via an interventional procedure. The stent expanded evenly, remained firmly fixed in the lumen, and did not shift, supporting the lumen without affecting blood flow in distal branches. A second stent was implanted in situ at 12 months. The implant went smoothly, with no restriction on stent expansion, and the vessel was able to expand to the desired diameter. Upon removal, significant degradation of the first stent was observed.

[0191] Example 20

[0192] This embodiment provides a pulmonary valve frame 1 made of cobalt-chromium alloy with a tensile strength of 1500 MPa and a yield strength of 1450 MPa. The frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of a plurality of interconnected cellular structures, each cellular structure in the same circumferential direction being formed by 18 struts, each 0.4 mm thick and 0.5 mm wide. The distal body 13 comprises a first support body 131 and a second support body 132, forming three M-shaped unit bodies 130. W-shaped openings 1301 are formed between adjacent unit bodies 130. The ratio of the area of ​​a single opening 1301 to the area formed by the distal body 13 and the combined area of ​​the openings 1301 is 10%. Reinforcements 133 are provided. The height of peak n2 is half that of peak n1. The combined surface area of ​​each first support 131 and the combined surface area of ​​each reinforcement 133 account for 2.5% and 2.0%, respectively, of the cylindrical surface area enclosed by each unit body 130. The first support angle β1 is 50°, while the second support angle β2 is 90°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 0.8 mm long. The length of the waist 112 accounts for 15% of the total length of the petal frame 1. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are both 1.2. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are both 7°.

[0193] The radial supporting force of the frame body 11 is 140kPa, the radial supporting force of the proximal body 12 is 120kPa, the radial supporting force of the distal body 13 is 100kPa, and the axial deformation is 6.2N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method. The stent expands evenly and can be well fixed in the lumen without displacement. It can support the lumen and does not affect the blood flow of the distal branch.

[0194] Example 21

[0195] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve. The valve frame 1 is made of an iron-manganese alloy with a tensile strength of 1500 MPa and a yield strength of 1450 MPa. The valve frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of multiple interconnected cellular structures, each circumferentially formed by 18 struts. The struts are 0.4 mm thick and 0.4 mm wide. The distal body 13 comprises a first support 131 and a second support 132, forming three M-shaped unit cells 130. W-shaped openings 1301 are formed between adjacent unit cells 130. The ratio of the area of ​​a single opening 1301 to the combined area of ​​the distal body 13 and the openings 1301 is 11%. Reinforcements 133 are provided. The height of peak n2 is half the height of peak n1. The combined surface area of ​​each first support 131 and the combined surface area of ​​each reinforcement 133 account for 2.0% and 1.5%, respectively, of the cylindrical surface area enclosed by each unit body 130. The included angle β1 of the first support is 75°, and the included angle β2 of the second support is 90°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 0.8 mm long. The length of the waist 112 accounts for 15% of the total petal frame length. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are both 1.2. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are both 7°.

[0196] The radial support force of the stent body 11 was 120 kPa, the radial support force of the proximal body 12 was 100 kPa, and the radial support force of the distal body 13 was 75 kPa. The axial deformation was 5.8 N. The stent 1 was implanted into the pulmonary valve of a dog via an interventional procedure. The stent expanded evenly, remained firmly fixed in the lumen, and did not shift. It supported the lumen without affecting blood flow in the distal branches. A second stent was implanted in situ at 12 months. The implantation went smoothly, and the stent expanded without being constrained by the original stent, allowing the vessel to expand to the desired diameter. The stent was then removed, revealing significant degradation of the first stent.

[0197] Example 22

[0198] This embodiment provides a pulmonary valve frame 1 made of cobalt-chromium alloy with a tensile strength of 1500 MPa and a yield strength of 1450 MPa. The frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of a plurality of interconnected cellular structures, each cellular structure in the same circumferential direction being formed by 18 struts, each 0.4 mm thick and 0.5 mm wide. The distal body 13 comprises a first support body 131 and a second support body 132, forming three M-shaped unit bodies 130. W-shaped openings 1301 are formed between adjacent unit bodies 130. The ratio of the area of ​​a single opening 1301 to the area formed by the distal body 13 and the combined area of ​​the openings 1301 is 10%. Reinforcements 133 are provided. The height of peak n2 is half that of peak n1. The combined surface area of ​​each first support 131 and the combined surface area of ​​each reinforcement 133 account for 2.5% and 2.0%, respectively, of the cylindrical surface area enclosed by each unit body 130. The first support angle β1 is 50°, while the second support angle β2 is 90°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 0.8 mm long. The length of the waist 112 accounts for 15% of the total length of the petal frame 1. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are both 1.2. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are both 7°.

[0199] The radial supporting force of the frame body 11 is 140kPa, the radial supporting force of the proximal body 12 is 120kPa, the radial supporting force of the distal body 13 is 100kPa, and the axial deformation is 6.2N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method. The stent expands evenly and can be well fixed in the lumen without displacement. It can support the lumen and does not affect the blood flow of the distal branch.

[0200] Example 23

[0201] This embodiment provides an iron-based absorbable pulmonary valve frame 1, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of a plurality of interconnected cellular structures 14, each cellular structure 14 in the same circumferential direction being formed by 24 support rods with a wall thickness of 0.35 mm and a width of 0.15 mm. The distal body 13 comprises a first support body 131 and a second support body 132, forming four M-shaped unit cells 130. W-shaped openings 1301 are formed between adjacent unit cells 130. The ratio of the area of ​​a single opening 1301 to the area formed by the distal body 13 and the combined area of ​​the openings 1301 is 15%. Reinforcements 133 are provided. The height of peak n2 is half that of peak n1. The combined surface areas of the first support bodies 131 and the reinforcements 133 account for 1.5% and 1.3%, respectively, of the cylindrical surface area enclosed by the unit bodies 130. The angle β1 of the first support body is 40°, and the angle β2 of the second support body is 110°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 3.5 mm long. The waist 112 accounts for 20% of the total stent length. The stent is tilted at both ends. The frame 11 has a diameter of 24 mm. The maximum diameter ratios of the proximal and distal bodies 12 and 13 to the frame 11 are both 1.3. The angles α3 and α4 between the lines connecting the apex of the distal and proximal bodies 13 and the midpoint of the waist 112 and the central axis of the frame 11 are both 9°.

[0202] The radial support force of the stent body 11 is 60 kPa, the radial support force of the proximal body 12 is 45 kPa, and the radial support force of the distal body 13 is 25 kPa. The axial deformation is 4.8 N. The stent was implanted into the pulmonary valve of a dog through an interventional procedure. The stent expanded evenly and remained firmly fixed in the lumen without displacement, supporting the lumen without affecting blood flow in distal branches. A second stent was implanted in situ at 12 months. The implantation went smoothly, with the stent expanding without being constrained by the original stent, allowing the vessel to expand to the desired diameter. When the stent was removed, significant degradation of the first stent was observed.

[0203] Example 24

[0204] This embodiment provides an iron-based absorbable pulmonary valve frame 1, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of a plurality of interconnected cellular structures 14. Each cellular structure 14, located in the same circumferential direction, is formed by 18 support rods arranged in a closed loop. The support rods have a wall thickness of 0.29 mm and a width of 0.4 mm. The distal body 13 comprises a first support body 131 and a second support body 132, forming three M-shaped unit cells 130. A W-shaped opening 1301 is formed between adjacent unit cells 130. The ratio of the area of ​​a single opening 1301 to the area formed by the distal body 13 and the combined area of ​​the openings 1301 is 17%. Reinforcements 133 are provided. The height of peak n2 is half that of peak n1. The combined surface area of ​​each first support 131 and the combined surface area of ​​each reinforcement 133 account for 1.8% and 1.6%, respectively, of the cylindrical surface area enclosed by each unit body 130. The included angle β1 of the first support is 40°, and the included angle β2 of the second support is 40°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 1.5 mm long. The length of the waist 112 accounts for 40% of the total petal frame length. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 28 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are both 1.5. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are both 25°.

[0205] The radial support force of the stent body 11 was 40 kPa, the radial support force of the proximal body 12 was 30 kPa, and the radial support force of the distal body 13 was 15 kPa, with an axial deformation of 5.1 N. The stent was implanted into the pulmonary valve of a dog using an interventional procedure. The stent expanded evenly, remained firmly fixed in the lumen, and did not shift, supporting the lumen without affecting blood flow in distal branches. A second stent was implanted in situ at 12 months. The implantation went smoothly, with the stent expanding without being constrained by the original stent, allowing the vessel to expand to the desired diameter. Upon removal, the stent was found to have significantly degraded from the original stent.

[0206] Example 25

[0207] This embodiment provides an iron-based absorbable pulmonary valve frame 1, made of nitrided iron with a tensile strength of 900 MPa and a yield strength of 850 MPa. The frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of a plurality of interconnected cellular structures 14. Each cellular structure 14 in the same circumferential direction is formed by 18 support rods arranged in a closed loop. The support rods have a wall thickness of 0.4 mm and a width of 0.5 mm. The distal body 13 comprises a first support body 131 and a second support body 132, forming three M-shaped unit bodies 130. A W-shaped opening 1301 is formed between adjacent unit bodies 130. The ratio of the area of ​​a single opening 1301 to the area formed by the distal body 13 and the combined area of ​​the openings 1301 is 18%. Reinforcements 133 are provided. The height of peak n2 is half the height of peak n1. The combined surface area of ​​each first support 131 and the combined surface area of ​​each reinforcement 133 account for 1.6% and 1.2%, respectively, of the cylindrical surface area enclosed by each unit body 130. The first support angle β1 is 60°, and the second support angle β2 is 60°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 2.5 mm long. The length of the waist 112 accounts for 25% of the total petal frame length. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 30 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are both 1.2. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are both 11°.

[0208] The stent 11 has a radial support force of 45 kPa, a proximal radial support force of 35 kPa, and a distal radial support force of 20 kPa, with an axial deformation of 6.1 N. The stent was implanted into the pulmonary valve of a dog using an interventional procedure. The stent expanded evenly, remained firmly fixed within the lumen, and did not shift, supporting the lumen without affecting blood flow in distal branches. A second stent was implanted in situ 12 months later. The implant went smoothly, with the stent expanding without being constrained by the original stent, allowing the vessel to expand to the desired diameter. Upon removal, significant degradation of the first stent was observed.

[0209] Example 26

[0210] This embodiment provides an iron-based absorbable pulmonary valve frame 1, made of nitrided iron with a tensile strength of 850 MPa and a yield strength of 800 MPa. The frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of a plurality of interconnected cellular structures 14. Each cellular structure 14, located in the same circumferential direction, is formed by 18 support rods arranged to form a closed loop. The support rods are 0.18 mm thick and 0.3 mm wide. The distal body 13 comprises a first support body 131 and a second support body 132, forming three M-shaped unit cells 130. W-shaped openings 1301 are formed between adjacent unit cells 130. The ratio of the area of ​​a single opening 1301 to the area formed by the distal body 13 and the combined area of ​​the openings 1301 is 15%. Reinforcements 133 are provided. The height of peak n2 is half the height of peak n1. The combined surface area of ​​each first support 131 and the combined surface area of ​​each reinforcement 133 account for 1.4% and 1.3%, respectively, of the cylindrical surface area enclosed by each unit body 130. The included angle β1 of the first support is 60°, and the included angle β2 of the second support is 170°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 2.8 mm long. The length of the waist 112 accounts for 15% of the total petal frame length. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are both 1.1. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are both 3°.

[0211] The radial support force of the stent body 11 was 12 kPa, the radial support force of the proximal body 12 was 8 kPa, and the radial support force of the distal body 13 was 6 kPa. The axial deformation was 1.6 N. The stent 1 was implanted into the pulmonary valve of a dog via an interventional procedure. The stent expanded evenly, remained firmly fixed in the lumen, and did not shift. It supported the lumen without affecting blood flow in the distal branches. A second stent was implanted in situ at 12 months. The implantation went smoothly, and the stent expansion was not constrained by the original stent, allowing the vessel to expand to the desired diameter. The stent was then removed, revealing significant degradation of the first stent.

[0212] Example 27

[0213] This embodiment provides an iron-based absorbable pulmonary valve frame 1, made of nitrided iron with a tensile strength of 850 MPa and a yield strength of 800 MPa. The frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of multiple interconnected cellular structures, each circumferentially connected by 18 support rods forming a closed loop. The support rods have a wall thickness of 0.28 mm and a width of 0.18 mm. The distal body 13 comprises a first support body 131 and a second support body 132, forming three M-shaped unit bodies 130. W-shaped openings 1301 are formed between adjacent unit bodies 130. The ratio of the area of ​​a single opening 1301 to the area formed by the distal body 13 and the combined openings 1301 is 13%. Reinforcements 133 are provided. The height of peak n2 is one-third of the height of peak n1. The combined surface areas of the first supports 131 and the reinforcements 133 account for 1.0% and 0.9%, respectively, of the cylindrical surface area enclosed by the unit cells 130. The included angle β1 of the first supports is 60°, and the included angle β2 of the second supports is 179°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 2.8 mm long. The length of the waist 112 accounts for 15% of the total petal frame length. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are both 1.3. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are both 10°.

[0214] The radial support force of the stent body 11 is 50 kPa, the radial support force of the proximal body 12 is 40 kPa, and the radial support force of the distal body 13 is 30 kPa. The axial deformation is 2.6 N. The stent 1 was implanted into the pulmonary valve of a dog via an interventional procedure. The stent expanded evenly and remained firmly fixed in the lumen without displacement, supporting the lumen without affecting blood flow in distal branches. A second stent was implanted in situ at 12 months. The implantation went smoothly, with the stent expanding without being constrained by the original stent, allowing the vessel to expand to the desired diameter. The stent was then removed, revealing significant degradation of the first stent.

[0215] Example 28

[0216] This embodiment provides a magnesium-based absorbable pulmonary valve frame 1, made of magnesium alloy with a tensile strength of 400 MPa and a yield strength of 350 MPa. The valve frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is composed of a plurality of interconnected cellular structures 14. Each cellular structure 14, located in the same circumferential direction, is formed by 18 support rods arranged in a closed loop. The support rods have a wall thickness of 0.3 mm and a rod width of 0.3 mm. The distal body 13 comprises a first support 131 and a second support 132. Specifically, the wall thickness and rod width of the first support 131 are locally increased by 1.3 times. The first and second support 131 and 132 form three M-shaped unit cells 130. W-shaped openings 1301 are formed between adjacent unit cells 130. The ratio of the area of ​​a single opening 1301 to the area formed by the distal body 13 and the combined area of ​​the openings 1301 is 14%. Reinforcements 133 are provided. The height of peak n2 is one-third of the height of peak n1. The combined surface area of ​​each first support 131 and the combined surface area of ​​each reinforcement 133 account for 1.6% and 1.3%, respectively, of the cylindrical surface area enclosed by each unit body 130. The included angle β1 of the first support is 40°, and the included angle β2 of the second support is 50°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 1.5 mm long. The length of the waist 11 accounts for 15% of the total petal frame length. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are both 1.3. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are both 10°.

[0217] The radial support force of the stent body 11 was 12 kPa, the radial support force of the proximal body 12 was 8 kPa, and the radial support force of the distal body 13 was 8 kPa. The axial deformation was 2.1 N. The stent 1 was implanted into the pulmonary valve of a dog via an interventional procedure. The stent expanded evenly, remained firmly fixed in the lumen, and did not shift. It supported the lumen without affecting blood flow in the distal branches. A second stent was implanted in situ at 12 months. The implantation went smoothly, and the stent expansion was not constrained by the original stent, allowing the vessel to expand to the desired diameter. The stent was then removed, revealing significant degradation of the first stent.

[0218] Example 29

[0219] This embodiment provides a magnesium-based absorbable pulmonary valve frame 1, made of magnesium alloy with a tensile strength of 500 MPa and a yield strength of 400 MPa. The valve frame 1 comprises a frame body 11, a proximal body 12, and a distal body 13. The frame body 11 is formed by interconnecting multiple cellular structures 14. Each cellular structure 14 in the same circumferential direction is composed of 18 struts, each strut having a wall thickness of 0.3 mm and a width of 0.28 mm. The distal body 13 comprises a first strut 131 and a second strut 132. Specifically, the wall thickness and width of the first strut 131 are locally increased by 1.5 times. The first and second struts 131 and 132 form three M-shaped unit cells 130, with W-shaped openings 1301 formed between adjacent unit cells 130. The area ratio of a single opening 1301 to the combined area of ​​the distal body 13 and the openings 1301 is 13%. Reinforcements 133 are provided. The height of peak n2 is one-third of the height of peak n1. The combined surface area of ​​each first support 131 and the combined surface area of ​​each reinforcement 133 account for 1.9% and 1.3%, respectively, of the cylindrical surface area enclosed by each unit body 130. The first support angle β1 is 75°, and the second support angle β2 is 90°. The distal body 13 is directly connected to the frame 11, while the proximal body 12 is connected to the frame 11 via a second connecting rod 15, which is 2.8 mm long. The length of the waist 112 accounts for 15% of the total petal frame length. The two ends of the petal frame 1 are raised. The diameter of the frame body 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame body 11 are both 1.3. The angles α3 and α4 between the lines connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the frame body 11 are both 10°.

[0220] The radial support force of the stent body 11 was 12 kPa, the radial support force of the proximal body 12 was 8 kPa, and the radial support force of the distal body 13 was 10 kPa. The axial deformation was 2.6 N. The stent 1 was implanted into the pulmonary valve of a dog via an interventional procedure. The stent expanded evenly, remained firmly fixed in the lumen, and did not shift. It supported the lumen without affecting blood flow in the distal branches. A second stent was implanted in situ at 12 months. The implantation went smoothly, and the stent expansion was not constrained by the original stent, allowing the vessel to expand to the desired diameter. The stent was then removed, revealing significant degradation of the first stent.

[0221] In order to further illustrate the technical effect of a degradable valve frame proposed in the application embodiment, an exemplary description is now given to supplement the comparative example.

[0222] Comparative Example 1

[0223] The design of the pulmonary valve stent in this comparative example is basically the same as that in Example 1, except that the stent material in this comparative example is a non-degradable cobalt-chromium alloy material.

[0224] The stent has a radial support force of 45kPa, an axial deformation resistance of 3.8N, and an anti-parallel plate extrusion force of 0.26N / mm; the stent was implanted into the pulmonary valve of a dog through an interventional method, and the stent was well fixed in the lumen without displacement, supporting the lumen, and did not affect the blood flow in the distal branches; a second stent was implanted in situ 12 months later. During stent expansion, the first stent was not deconstructed, causing restraint, making it difficult for the second implanted stent to expand and unable to expand to the rated diameter. The blood vessel was not expanded to the expected diameter, and the second implantation failed to meet surgical expectations.

[0225] Comparative Example 2

[0226] The design of the pulmonary valve stent in this comparative example is basically the same as that in Example 6, except that the wall thickness of the support rod on the frame body 11 in this comparative example is 0.08 mm, the coverage rate of the frame body 11 is 2.1%, and the coverage rate of the distal body 13 is 0.8%.

[0227] This stent design has a radial support force of 4kPa, an axial deformation resistance of 0.2N, and a parallel plate extrusion resistance of 0.03N / mm. When the stent was implanted into a dog's aortic valve via an interventional procedure, the radial support force, axial deformation resistance, and parallel plate extrusion resistance were too low, causing the stent to collapse under the pressure of the blood vessel and fail to effectively support the vessel. Upon removal, the stent was found to be flattened and axially deformed.

[0228] Comparative Example 3

[0229] The design of the pulmonary valve stent in this comparative example is basically the same as that in Example 1, except that the wall thickness of the support rod on the frame body 11 in this comparative example is 0.50 mm, the coverage rate of the frame body 11 is 20%, and the coverage rate of the distal body 13 is 8%.

[0230] The stent with this design has a radial support force of 160kPa, an axial deformation resistance of 8.2N, and an anti-parallel plate extrusion force of 1.1N / mm. When the stent was implanted into the pulmonary valve of a dog through an interventional method, the stent was well fixed in the lumen without displacement, supporting the lumen, and did not affect blood flow in distal branches. However, the stent wall thickness was too thick and the coverage rate was too high. When a second valve frame was implanted in situ 12 months later, the valve frame expansion was constrained and the blood vessel failed to fully expand to the expected diameter. After the valve frame was removed, it was seen that the first implanted valve frame had undergone significant degradation. However, the stent wall thickness was too thick and the coverage rate was too high, and the expected degree of deconstruction was not achieved, resulting in the failure of the second stent implantation.

[0231] Comparative Example 4

[0232] The design of the pulmonary valve stent in this embodiment is basically the same as that in Example 14, except that in this embodiment, the distal body does not have a unit body with an "M"-shaped profile and does not form a "W"-shaped opening.

[0233] The stent can be implanted into the pulmonary valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement and can support the lumen. However, the distal end of the stent affects the distal branch blood flow, reducing the branch blood flow.

[0234] Comparative Example 5

[0235] The design of the pulmonary valve stent in this embodiment is basically the same as that in Example 14, except that in this embodiment, the two ends of the stent are not raised, and the diameters of the distal body, proximal body and frame body of the stent are the same.

[0236] The stent can be implanted into the dog's pulmonary valve through interventional methods, but the stent is difficult to fix in the lumen and is prone to displacement.

[0237] Comparative Example 6

[0238] The design of the pulmonary valve stent in this embodiment is basically the same as that in Example 15, except that no reinforcement is provided in this embodiment.

[0239] The radial support force of the stent body is 6kPa, the radial support force of the proximal body is 6kPa, the radial support force of the distal body is 6kPa, and the axial deformation is only 0.5N; the stent can be implanted into the pulmonary valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of the distal branch, but the distal body undergoes axial deformation and twists and punctures the blood vessel.

[0240] Comparative Example 7

[0241] The design of the pulmonary valve stent in this embodiment is basically the same as that in Example 15, except that in this embodiment, the first support body angle β1 is 30°, and the second support body angle β2 is 30°.

[0242] The radial support force of the stent body is only 4kPa, the radial support force of the proximal body is only 3kPa, the radial support force of the distal body is only 2kPa, and the axial deformation is 1.6N; the stent can be implanted into the pulmonary valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement, but the stent support force is low and cannot support the blood vessels. After the balloon pressure is released, the stent is collapsed by the blood vessels.

[0243] Comparative Example 8

[0244] The design of the pulmonary valve stent in this embodiment is basically the same as that in Example 14, except that the stent in this embodiment is not a fully closed design.

[0245] The radial support force of the stent body is 28kPa, the radial support force of the proximal body is 20kPa, the radial support force of the distal body is 12kPa, and the axial deformation is 2.6N; the stent can be implanted into the pulmonary valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement, but the uneven expansion of the stent leads to uneven distribution of the valve, the valve cannot be completely closed, and regurgitation occurs.

[0246] The above is only a preferred specific implementation method of the present application, but the scope of protection of the present application is not limited thereto. Rather, any changes or replacements that can be easily thought of by any technician familiar with the technical field within the technical scope disclosed in the present application should be included in the scope of protection of the present application.

Claims

1. A degradable valve frame, comprising a frame body formed in a preset shape, and a proximal body and a distal body respectively connected to the axial ends of the frame body, wherein the frame body, the proximal body and the distal body as a whole form a circumferentially closed annular structure, characterized in that: The frame body, the proximal body and the distal body are at least partially configured to be degradable, so that the circumferentially closed annular structure of the degradable valve frame can be decomposed.

2. The degradable valve frame according to claim 1, characterized in that: The total surface area of ​​the degradable part of the degradable valve frame accounts for more than or equal to 0.5% of the total surface area of ​​the degradable valve frame as a whole; or the total surface area of ​​the degradable part of the degradable valve frame accounts for more than or equal to 5% of the total surface area of ​​the degradable valve frame as a whole; Or the total surface area of ​​the degradable part of the degradable valve frame accounts for greater than or equal to 99% of the total surface area of ​​the degradable valve frame as a whole.

3. The degradable valve frame according to claim 1, characterized in that: The radial supporting force of the degradable valve frame is [6kPa, 140kPa]; or the radial supporting force of the degradable valve frame is [10kPa, 120kPa]; or the radial supporting force of the degradable valve frame is [12kPa, 100kPa].

4. The degradable valve frame according to claim 1, characterized in that: The coverage rate of the degradable valve frame is [4%, 18%]; the coverage rate of the degradable valve frame is [4%, 15%]; the coverage rate of the degradable valve frame is [4%, 8%).

5. The degradable valve frame according to claim 1, characterized in that: The wall thickness of the degradable valve frame is 0.10mm-0.40mm; the wall thickness of the degradable valve frame is 0.15mm-0.4mm; the wall thickness of the degradable valve frame is 0.18mm-0.35mm.

6. The degradable valve frame according to claim 1, characterized in that: The anti-parallel plate extrusion force of the degradable valve frame is not less than 0.05N / mm.

7. The degradable valve frame according to claim 1, characterized in that: The degradable valve frame is a valve frame for a pulmonary valve, with a radial supporting force of [10kPa, 80kPa], a coverage rate of the valve frame of [4%, 13%], and a wall thickness of 0.15mm-0.35mm; or the degradable valve frame is a valve frame for an aortic valve, with a radial supporting force of [30kPa, 120kPa], a coverage rate of the valve frame of [5%, 15%], and a wall thickness of 0.18mm-0.40mm; or the degradable valve frame is a valve frame for a mitral valve, with a radial supporting force of [30kPa, 100kPa], a coverage rate of the valve frame of [5%, 13%], and a wall thickness of 0.18mm-0.35mm; or the degradable valve frame is a valve frame for a tricuspid valve, with a radial supporting force of [30kPa, 110kPa], a coverage rate of the valve frame of [5%, 14%], and a wall thickness of 0.18mm-0.38mm.

8. The degradable valve frame according to claim 1, characterized in that: The degradable valve frame is a valve frame for a pulmonary valve, with a radial supporting force of [6kPa, 80kPa], a coverage rate of the valve frame of [4%, 13%], and a wall thickness of 0.15mm-0.35mm; or the degradable valve frame is a valve frame for an aortic valve, with a radial supporting force of [30kPa, 140kPa], a coverage rate of the valve frame of [5%, 18%], and a wall thickness of 0.18mm-0.40mm; or the degradable valve frame is a valve frame for a mitral valve, with a radial supporting force of [12kPa, 100kPa], a coverage rate of the valve frame of [5%, 13%], and a wall thickness of 0.15mm-0.35mm; or the degradable valve frame is a valve frame for a tricuspid valve, with a radial supporting force of [30kPa, 110kPa], a coverage rate of the valve frame of [5%, 14%], and a wall thickness of 0.15mm-0.38mm.

9. The degradable valve frame according to claim 1, characterized in that: The frame body, the proximal body and / or the distal body respectively include a plurality of lattice structures, and each of the lattice structures is in a fully closed shape.

10. The degradable valve frame according to claim 9, characterized in that: The lattice structure includes crests and troughs, and the angle α1 between two adjacent support rods used to form the crests or troughs on the frame is 50°-160°, and the angle α2 between two adjacent support rods used to form the crests or troughs of the proximal body and / or the distal body is 40°-179°.

11. The degradable valve frame according to claim 10, characterized in that: Along the circumferential direction of the frame, the total number of the support rods surrounding each of the lattice structures at the same position is 12-48.

12. The degradable valve frame according to claim 10, characterized in that: Along the direction from the proximal body to the distal body, the wave crest of the nth lattice structure is connected to the wave trough of the n+1th lattice structure directly or through a first connecting rod; wherein n≥1, and the length of the first connecting rod is 0.1-3.0 mm.

13. The degradable valve frame according to claim 1, characterized in that: The coverage rate of the distal body is less than or equal to 6%.

14. The degradable valve frame according to any one of claims 1 to 13, characterized in that: The axial deformation resistance of the degradable valve frame is not less than 0.3N; the axial deformation resistance of the degradable valve frame is not less than 1N.

15. The degradable valve frame according to any one of claims 1 to 13, characterized in that: The length of the frame is 15%-75% of the total valve frame length; the length of the frame is 20%-65% of the total valve frame length.

16. A valve holder for a pulmonary valve, characterized in that: It includes a tubular frame body, and a proximal body and a distal body respectively connected to the two axial ends of the frame body, the frame body includes a plurality of pore structures, and is characterized in that the distal body includes a plurality of unit bodies with an "M"-shaped outline, wherein the number of the unit bodies is m, and m is a natural number greater than or equal to 2.

17. A valve frame for a pulmonary valve, characterized in that: The degradable valve frame comprises the degradable valve frame as described in any one of claims 1 to 6 and 9 to 15, wherein the distal body comprises a plurality of unit bodies with an "M"-shaped outline, wherein the number of the unit bodies is m, and m is a natural number greater than or equal to 2.

18. The valve frame according to claim 16 or 17, characterized in that: The unit body includes a first support body and a second support body which are connected to each other at one end, and one end where the first support body and the second support body are connected is connected to the frame body.

19. The valve frame according to claim 16 or 17, characterized in that: A "W"-shaped opening is formed between two adjacent unit bodies, and the ratio of the area of ​​a single opening to the area of ​​a region formed by the distal body and the openings is ≥10%.

20. The valve frame according to claim 18, characterized in that: The first support is bent to form a crest n1, and the second support is bent in the same direction to form a crest n2. The height of the crest n2 of the second support is less than or equal to 2 / 3 of the height of the crest n1 of the first support on both sides.

21. The valve frame according to claim 18, characterized in that: The width of the first support body is 1.0-3.5 times the width of the second support body.

22. The valve frame according to claim 16 or 17, characterized in that: The unit body further includes a reinforcing member, which is disposed between the frame body and the distal body, and is connected to at least the first supporting body.

23. The valve frame according to claim 18, characterized in that: The total surface area of ​​each of the first supporting bodies accounts for ≤2.5% of the cylindrical side surface area surrounded by the combination of each of the unit bodies; the total surface area of ​​each of the reinforcing members accounts for ≤2.0% of the cylindrical side surface area surrounded by the combination of each of the unit bodies.

24. The valve frame according to claim 18, characterized in that: The size of the angle formed by the bending of the first support body is [40°, 110°] and / or the size of the angle formed by the bending of the second support body is [40°, 179°].

25. The valve frame according to claim 16 or 17, characterized in that: The frame body has a waist with a uniform diameter, and a connecting portion extending from the edge of the waist toward the proximal body and / or the distal body and having a gradually increasing diameter. The proximal body and the distal body are respectively connected to the corresponding connecting portions.

26. The valve frame according to claim 25, characterized in that: The length of the waist is 15%-60% of the total valve frame length; the length of the waist is 20%-40% of the total valve frame length.

27. The valve holder according to any one of claims 16 to 26, characterized in that: The radial supporting force of the frame is [6kPa, 140kPa]; the radial supporting force of the proximal body is [6kPa, 120kPa]; the radial supporting force of the distal body is [6kPa, 100kPa]; and the deformation resistance of the distal body is greater than or equal to 1.5N.

28. The degradable valve frame according to any one of claims 1 to 15 or the valve frame for a pulmonary valve according to any one of claims 16 to 27, characterized in that: The angle between the line connecting the vertex of the distal body and the midpoint of the frame and the central axis of the frame is α3, and the angle between the line connecting the vertex of the proximal body and the midpoint of the frame and the central axis of the frame is α4, and the size of α3 or α4 is between (0°, 30°], where α3=α4, or α3≠α4, or α3 is less than α4.

29. The degradable valve frame according to any one of claims 1 to 15 or the valve frame for a pulmonary valve according to any one of claims 16 to 27, characterized in that: The ratio of the maximum diameter of the proximal body and / or the distal body to the minimum diameter of the frame is [1, 1.8]:1, and the ratio of the maximum diameter of the proximal body and / or the distal body to the minimum diameter of the frame is (1, 1.8]:

1.

30. The degradable valve frame according to any one of claims 1 to 15 or the valve frame for a pulmonary valve according to any one of claims 16 to 27, characterized in that: The proximal body and / or the distal body are directly connected to the frame body or connected via a second connecting rod.

31. The valve frame according to claim 30, characterized in that: The length of the second connecting rod is 0.8 mm-4.0 mm.

32. The degradable valve frame according to claim 1 or the valve frame for pulmonary valve according to claim 16 or 17, characterized in that: The yield strength of the valve frame substrate is 350MPa-1450MPa; and / or the tensile strength of the valve frame substrate is 400MPa-1500MPa.

33. The degradable valve frame according to claim 1 or the valve frame for a pulmonary valve according to claim 16 or 17, characterized in that: The material of the degradable part of the valve frame is at least one of metal or non-metal; wherein the metal includes at least any one of pure iron, iron alloy, pure magnesium, magnesium alloy, pure zinc or zinc alloy; the non-metal includes at least any one of degradable polyester, degradable polyanhydride and binary or multi-component degradable copolymers copolymerized with their corresponding monomers, wherein the degradable polyester includes at least one of polylactic acid, polyglycolic acid, polylactic glycolic acid, polycaprolactone, polylactide, polyglycolide, polycaprolactide, polyhydroxyalkanoate, polyacrylate, polysuccinate, poly(β-hydroxybutyrate), polyethylene adipate and polyhydroxybutyrate valerate copolymer; The anhydride includes at least one of poly 1,3-bis(p-carboxyphenoxy)propane-sebacic acid, polyerucic acid dimer-sebacic acid or polyfumaric acid-sebacic acid; or the non-metal includes at least a degradable polyamino acid or a degradable tyrosine-derived polymer, and the degradable polyamino acid includes at least one of polyglycine, polyalanine, polyvaline, polyleucine, polyisoleucine, polymethionine, polyproline, polytryptophan, polyserine, polytyrosine, polycysteine, polyphenylalanine, polyasparagine, polyglutamine, polythreonine, polyarginine, polyhistidine, polyselenocysteine, polypyrroline, polyglutamic acid, polyaspartic acid, polyornithine, polylysine and derivatives thereof;The degradable tyrosine-derived polymers include methyl (2R)-2-amino-3-(2-chloro-4-hydroxyphenyl) propionate, D-tyrosine ethyl ester hydrochloride, methyl (2R)-2-amino-3-(2,6-dichloro-3,4-dimethoxyphenyl) propionate HD-Tyr(TBU)-allyl ester HCl, methyl (2R)-2-amino-3-(3-chloro-4,5-dimethoxyphenyl) propionate, methyl (2R)-2-amino-3-(2-chloro-3-hydroxy-4-methoxyphenyl) propionate, methyl (2R)-2-amino-3-(4-[(2-chloro-6-fluorophenyl)methoxy]phenyl) propionate, methyl (2R)-2-amino-3-(2-chloro-3-hydroxy-4-methoxyphenyl) propionate, methyl (2R)-2-amino-3-(4-[(2-chloro-6-fluorophenyl)methoxy]phenyl) propionate, methyl (2R)-2-amino-3-(2-chloro -3,4-dimethoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(3-chloro-5-fluoro-4-hydroxyphenyl)propionic acid methyl ester, 2-(acetylamino)-2-(4-[(2-chloro-6-fluorobenzyl)oxy]benzylmalonate diethyl, (2R)-2-amino-3-(3-chloro-4-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(3-chloro-4-hydroxy-5-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(2,6-dichloro-3-hydroxy-4-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(3-chloro-4-hydroxyphenyl)propionic acid methyl ester, H-DL-tyr-OME HCl, H-3,5-diiodo-tyr-OME HCl, HD-3,5-diiodo-tyr-OME HCl, HD-tyr-OMEHCl, D-tyrosine methyl ester hydrochloride, D-tyrosine-ome HCl, D-tyrosine methyl ester hydrochloride, HD-tyr-OMe·HCl, D-tyrosine methyl ester HCl, HD-Tyr-OMe-HCl, (2R)-2-amino-3-(4-hydroxyphenyl)propionic acid, (2R)-2-amino-3-(4-hydroxyphenyl)methyl ester hydrochloride, (2R)-2-amino-3-(4-hydroxyphenyl)propionic acid methyl ester hydrochloride, (2R)-2-azanyl-3-(4-hydroxyphenyl)propionic acid methyl ester hydrochloride, 3-chloro-L-tyrosine, 3-nitro-L-tyrosine, 3-nitro-L-tyrosine ethyl ester hydrochloride, DL-m-tyrosine, DL-o-tyrosine, Boc-Tyr(3,5-I2)-OSu, Fmoc-tyr(3-NO2)-OH, α-methyl-L-tyrosine, α-methyl-D-tyrosine and α-methyl-DL-tyrosine. ; 34. A pulmonary valve, characterized in that: It comprises a valve leaflet and a valve frame for a pulmonary valve as claimed in any one of claims 16 to 33, wherein the valve leaflet is connected to the valve frame for the pulmonary valve.

35. A heart valve, characterized in that: It comprises a valve leaflet and a degradable valve frame as described in any one of claims 1 to 15 and 28 to 33, wherein the valve leaflet is connected to the degradable valve frame.

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