Degradable valve frame and heart valve

Abstract

The invention belongs to the technical field of interventional medical instruments, and particularly relates to a degradable valve frame and a heart valve. The degradable valve frame comprises a frame body formed according to a preset shape, a near-end body and a far-end body, the near-end body and the far-end body are connected to the two axial ends of the frame body respectively, the frame body, the near-end body and the far-end body integrally form a circumferentially-closed annular structure, and at least parts of the frame body, the near-end body and the far-end body are degradable. Therefore, the circumferentially closed annular structure of the degradable valve frame is deconstructed. The heart valve comprises valve leaflets and the degradable valve frame, and the valve leaflets are connected to the degradable valve frame. According to the degradable valve frame, the strength of the radial supporting force meets the application requirement, the degradable valve frame has the degradable performance and can be decomposed, the circumferentially-closed annular structure is deconstructed, difficulty and obstacles cannot be brought to follow-up implantation, and the use requirement is well met.

Description

Technical Field

[0001] The present application belongs to the technical field of interventional medical devices, and specifically relates to a degradable valve frame and a heart valve. Background Art

[0002] Heart valve disease is a common heart disease, and its causes include congenital and acquired. Congenital refers to valve lesions found at birth, while acquired refers to valve damage that gradually occurs during the long-term opening and closing of the valve day and night, which leads to valve stenosis or incomplete closure, and poor blood flow or blood backflow. With the aging of the population, senile valvular disease and valvular lesions caused by coronary heart disease and myocardial infarction are becoming more and more common. Currently, common treatments for this type of disease include valve replacement by surgery or minimally invasive transcatheter implantation. Since it is difficult to directly sew the external valve to the heart's valve ring and maintain a good closure effect with current technology, the surgical valve or implanted valve used in the two commonly used treatment methods uses a valve frame to position and fix the valve, and then puts it into the corresponding position through surgery or implantation to solve problems such as stenosis or incomplete closure of the diseased valve.

[0003] The valve frames on the valves currently on the market are basically made of non-degradable materials, such as 316L stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc. These materials exist in the human body for a long time as foreign matter, which can easily cause excessive proliferation of the endothelium, causing mid- and late-stage restenosis of the blood vessels, chronic inflammation, late-stage and very late-stage thrombosis, and other problems. It will also cause problems such as difficulty in secondary implantation. Especially for some patients with congenital valvular lesions, as they age, their hearts gradually grow, and the size of the valves also needs to be adapted. If the valve frame of the previously implanted valve is not deconstructible ("deconstruction" means that the valve frame is circumferentially separated and broken and is no longer a closed annular structure, so it loses radial support ability and is no longer limited to the range that can be supported in the radial direction), then the subsequent re-implantation of the valve frame will inevitably be restricted, which will bring great difficulties to the subsequent implantation and leave many hidden dangers to the health of the patient. Therefore, it is necessary to develop an absorbable valve frame that can not only play a supporting role, but also gradually degrade and deconstruct, and even be absorbed by the body until it disappears completely, so as to avoid the appearance of multiple valve frames in the body, thereby causing corresponding safety hazards. Summary of the invention

[0004] The purpose of the present application is to overcome one of the above-mentioned technical problems and to provide a degradable valve frame which has good mechanical properties, can provide effective support, requires less material, has a short degradation cycle, and meets the requirements of not restricting the re-implantation of the valve frame and avoiding the presence of multiple valve frames in the body.

[0005] 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 respectively connected to the axial ends of the frame body, wherein the frame body, the proximal body and the distal body as a whole constitute a circumferentially closed annular structure, and 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 deconstructed.

[0006] In some embodiments, the total surface area of ​​the degradable portion of the degradable valve frame accounts for greater 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 portion of the degradable valve frame accounts for greater 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 portion 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.

[0007] In some embodiments, the radial supporting force of the entire 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].

[0008] In some embodiments, the coverage rate of the degradable valve frame is [4%, 18%]; or the coverage rate of the degradable valve frame is [4%, 15%]; or the coverage rate of the degradable valve frame is [4%, 8%).

[0009] In some embodiments, the wall thickness of the degradable valve frame is 0.10mm-0.40mm; or the wall thickness of the degradable valve frame is 0.15mm-0.4mm, or the wall thickness of the degradable valve frame is 0.18mm-0.35mm.

[0010] In some embodiments, the anti-parallel plate extrusion force of the degradable valve frame is not less than 0.05 N / mm.

[0011] In some embodiments, the degradable valve frame is a valve frame for a pulmonary valve, with a radial support 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 support 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 support 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 support force of [30kPa, 110kPa], a coverage rate of the valve frame of [5%, 14%], and a wall thickness of 0.18mm-0.38mm.

[0012] In some embodiments, the degradable valve frame is a valve frame for a pulmonary valve, with a radial support 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 support 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 support 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 support force of [30kPa, 110kPa], a coverage rate of the valve frame of [5%, 14%], and a wall thickness of 0.15mm-0.38mm.

[0013] In some embodiments, 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 fully closed.

[0014] In some embodiments, 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°.

[0015] In some embodiments, 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.

[0016] In some embodiments, 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, where n≥1; and the length of the first connecting rod is 0.1-3.0 mm.

[0017] In some embodiments, the coverage of the distal body is less than or equal to 6%.

[0018] In some embodiments, the yield strength of the degradable valve frame substrate is 350 MPa-1450 MPa; and / or the tensile strength of the degradable valve frame substrate is 400 MPa-1500 MPa.

[0019] In some embodiments, the material of the degradable part of the degradable 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, and the degradable polyester includes at least one of polylactic acid, polyglycolic acid, polylactic acid glycolic acid, polycaprolactone, polylactide, polyglycolide, polycaprolactide, 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 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. ;

[0020] In some embodiments, the proximal body and / or the distal body are directly connected to the frame or connected via a second connecting rod.

[0021] In some embodiments, the length of the second connecting rod is 0.8 mm-4.0 mm.

[0022] In some embodiments, the axial deformation resistance of the degradable valve frame is not less than 0.3N; or the axial deformation resistance of the degradable valve frame is not less than 1N.

[0023] In some embodiments, the length of the frame is 15%-75% of the total valve frame length; or the length of the frame is 20%-65% of the total valve frame length.

[0024] In some embodiments, 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.

[0025] A second aspect of the present application provides a heart valve, comprising leaflets and the above-mentioned degradable valve frame, wherein the leaflets are connected to the degradable valve frame.

[0026] The present application provides a degradable valve frame and a heart valve, the degradable valve frame 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 constitute a circumferentially closed annular structure as a whole, and the frame body, the proximal body and the distal body are all set to be at least partially degradable. In this way, the degradable valve frame of this structure not only has degradable properties, 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 limitation of the support range in the radial direction is lost, which will not bring difficulties and obstacles to subsequent implantation, and the degradable valve frame as a whole also has good support performance, and the strength of the radial support force meets the application requirements, so that the heart valve can be effectively supported and degraded by using the degradable valve frame, and it will not cause restrictions on re-implantation, which well meets the support performance and degradable performance of the stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Various other advantages and benefits will become apparent to those of ordinary skill in the art by reading the detailed description of the preferred embodiments below. The accompanying drawings are only for the purpose of illustrating the preferred embodiments and are not to be considered as limiting the present application. In addition, the same reference numerals are used throughout the accompanying drawings to represent the same components. Among them:

[0028] Figure 1 A schematic diagram of the structure of the degradable valve frame after expansion provided in an embodiment of the present application;

[0029] Figure 2 A schematic diagram of a planar structure of a degradable valve frame in a compressed state provided in an embodiment of the present application;

[0030] Figure 3A schematic diagram of a planar structure of a degradable valve frame in a compressed state provided in an embodiment of the present application;

[0031] Figure 4 A schematic diagram of the structure of the second degradable valve frame after expansion provided in an embodiment of the present application;

[0032] Figure 5 A schematic diagram of the decomposable valve frame after expansion provided in an embodiment of the present application;

[0033] Figure 6 A schematic diagram of the structure of a second distal body in a degradable valve frame provided in an embodiment of the present application;

[0034] Figure 7 A schematic structural diagram of the third distal body in the degradable valve frame provided in an embodiment of the present application. DETAILED DESCRIPTION

[0035] The exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the 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. On the contrary, 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.

[0036] It should be noted that the symbol “ / ” in the present 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”.

[0037] For ease of description, spatial 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 figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0038] Test method:

[0039] 1. Radial support force of the stent

[0040] The present invention uses a radial support force tester produced by Blockwise to test the radial support force in the following manner:

[0041] After the valve frame (stent) is expanded to its rated diameter D, the part of the valve frame to be tested is placed in a 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.

[0042] 2. Brackets resist parallel plate extrusion force

[0043] The test of the stent's resistance to the parallel plate extrusion force in the present invention is carried out on a microcomputer-controlled universal mechanical testing machine. The valve frame is first expanded to its rated diameter D, at which time the length of the valve frame is L, and then placed between two parallel plates. The extrusion force N exerted by the parallel plates on the stent when the valve frame is compressed to 50% of the 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:

[0044]

[0045] It should be noted that for the flap frame with a flared end, the flap frame must be compressed as a whole to the same diameter as the frame body before testing.

[0046] like Figure 1 and Figure 2 As shown, a degradable valve frame 1 is provided in an embodiment of the present application, and 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 use requirements, and is a hollow structure to form a channel, and the channel is used for blood flow. The cross-sectional profile shape of the frame body 11 perpendicular to the axis is circular. Of course, it can be understood that other shapes such as hexagons or octagons can also be formed according to the use requirements. 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 constitute a circumferentially closed annular structure, so that the overall structure is stable and can have good supporting performance. Among them, the frame body 11, the proximal body 12 and the distal body 13 as a whole constitute a circumferentially closed annular structure. The frame body 11, the proximal body 12 and the distal body 13 can be three circumferentially closed annular structures respectively, and the whole is still a circumferentially closed annular structure after being connected; or it can be a circumferentially closed annular structure formed as a whole after the three are connected.

[0047] 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 in 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.

[0048] 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 part is broken after being decomposed, and the closed structure of the valve frame in the circumferential direction is destroyed. Specifically, the frame body 11, the proximal body 12 and the distal body 13 are respectively configured to be at least partially degradable, and after each degradable part is degraded, each degradable position is broken, and under the joint action of each broken part, the entire valve frame can be deconstructed in the circumferential direction, and is no longer a closed annular structure, and thus loses the limitation of the support range in the radial direction, no longer has the limiting ability, and can be expanded, and will not cause restrictions on the subsequent implantation of a valve frame with a larger radial size, which well meets the use requirements of the valve frame having degradable properties and not causing restrictions on the subsequent re-implantation of the valve frame.

[0049] A degradable valve frame 1 provided in the embodiment of the present application is composed of a frame body 11, a proximal body 12 and a distal body 13 to form a circumferentially closed annular structure, and the frame body 11, the proximal body 12 and the distal body 13 are at least partially degradable, and after each degradable part is degraded, the circumferentially closed annular structure of the valve frame can be decomposed and expanded. The degradable valve frame 1 of this structure not only has degradable properties, but also can be degraded and absorbed within a preset time, and will not degrade prematurely and bring difficulties and obstacles to subsequent implantation. In addition, the overall structure of the degradable valve frame 1 is stable, and can have more appropriate support performance. The strength of the radial support force meets the application requirements and has good reliability in use.

[0050] In some possible embodiments, 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. Further, 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; further, the total surface area of ​​the degradable part of the degradable valve frame accounts for more than 99% of the total surface area of ​​the degradable valve frame as a whole. In order to enable the degradable part to effectively break and deconstruct the valve frame after degradation, it is necessary to make the area where the degradable part is set large enough. Among them, "the total surface area of ​​the degradable valve frame 1 as a whole" refers to the sum of the area of ​​the outer wall of the degradable valve frame 1 and the area of ​​the side wall, the side wall refers to the surface connected between the outer wall and the inner wall, and the inner wall refers to the surface opposite to the outer wall, which is also the inner wall surface of the inner cavity of the valve frame. "The total surface area of ​​the degradable part" refers to all the areas belonging to the degradable part in the total surface area of ​​the degradable valve frame 1 as a whole. 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 decomposed during the degradation process.

[0051] 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 ring and the valve is not easily washed away by the blood flow, while also avoiding the radial support force of the degradable valve frame 1 being too large, causing damage to the valve ring 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.

[0052] In some possible embodiments, the radial support force of the degradable valve frame 1 is [10kPa, 120kPa]; or [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 supporting 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 realized 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.

[0053] In some possible implementation schemes, the frame body 11, the proximal body 12 and the distal body 13 can all be set to be degradable, that is, the entire valve frame can be degraded. In this way, any position of the valve frame can be degraded. During the degradation process, it is only necessary to destroy the closed structure of the valve frame in the circumferential direction at the position where the valve frame is broken after degradation, without waiting for the entire valve frame to be degraded, thereby increasing the possibility of the valve frame being degraded and broken, and further improving the reliability of the closed structure of the valve frame in the circumferential direction being destroyed after degradation, and no longer having the ability to limit the radial support range.

[0054] In the embodiment of the present application, in order to achieve that the valve frame can be degraded within a preset time after being implanted in a living body without restricting the subsequent re-implantation, the degradable valve frame 1 is set to be partially degradable or wholly degradable. When it is partially degradable, the degradable position can decompose the valve frame as a whole and no longer restrict the newly implanted valve. For example, the degradable part is set in the same straight line in the axial direction, so that 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 re-implantation operation of the valve frame can be performed. When the whole can be degraded, that is, any position of the entire degradable valve frame 1 can be degraded, which increases the possibility of degradation and fracture of the valve frame. During the degradation process, as long as the parts that break after each degradation can cause the closed structure of the valve frame in the circumferential direction to be destroyed, the overall deconstruction 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, and meets the use requirements of re-implantation.

[0055] Specifically, the time for the degradable valve frame 1 to degrade to overall deconstruction is maintained within a preset time period, and there will be no risk of premature deconstruction leading to the disappearance of supporting performance and restenosis of the supported part. There will also be no problem of not deconstructing beyond the preset time period and thus limiting reimplantation, and the inability 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 prescribed time, but it can also be completely degraded and will not remain in the body, which is convenient for reimplantation of the valve frame and avoids the long-term safety hazards caused by the presence of multiple valve frames in the body.

[0056] The degradable valve frame 1 provided in the present application has a coverage rate of [4%, 18%]; further, the coverage rate is [4%, 15%]; further, the coverage rate is [4%, 10%]; further, the coverage rate is [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. In this way, in actual applications, the most suitable coverage rate of the degradable valve frame 1 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.

[0057] 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.

[0058] 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:

[0059] Surface coverage = A = Sr / Ss × 100%;

[0060] 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 by CAD software;

[0061] Ss: the total external surface area of ​​the valve frame covered segment after expansion, Ss = π × D1 × L1;

[0062] D1: valve frame diameter after expansion;

[0063] L1: The length of the valve frame after expansion.

[0064] 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, and 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 materials are used, and the more disadvantageous it is to the body, especially when the material of the valve frame is degradable, the more materials are used, the more products are degraded in the body, and the heavier the burden of absorption / removal of products brought to 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, reduce the burden of absorption / removal 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.

[0065] The degradable valve frame 1 provided in the present application has an anti-parallel plate extrusion pressure 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 evenly distributed along the length of the overall stent. The anti-parallel plate extrusion pressure is within this numerical range, so that the degradable valve frame 1 has good anti-flattening performance, and can meet the use requirements of being subjected to extrusion pressure in the radial direction along the length of the overall stent. In this way, the damage caused by 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 pressure, which can greatly improve the safety and reliability of use.

[0066] In an embodiment of the present application, the degradable valve frame 1 is a valve frame for the 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 1 is a valve frame for the 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 1 is a valve frame for the 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 1 is a valve frame for the 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.

[0067] In other embodiments, the degradable valve frame is a valve frame for the pulmonary valve, with a radial support 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 the aortic valve, with a radial support 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 the mitral valve, with a radial support 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 the tricuspid valve, with a radial support force of [30kPa, 110kPa], a coverage rate of the valve frame of [5%, 14%], and a wall thickness of 0.15mm-0.38mm.

[0068] 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, and 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 is continuously compressed in the axial direction and an irreversible deformation occurs. The deformation resistance is in this numerical range, so that the degradable valve frame 1 has a good axial support performance and can meet the use requirements of axial force and pressure resistance. In this way, the damage caused by the irreversible deformation of the degradable valve frame 1 under pressure in the axial direction can be reduced, such as changes in the axial support position, resulting in a deterioration or failure of the support effect, or a series of uncontrollable adverse effects such as protrusions or sharp points toward the tissue and stabbing the tissue. For example, in the scenario where the end of the degradable valve frame 1 needs to be inserted into the tissue flesh, if the strength of the axial support force is too small, it is easy to fail to penetrate into the tissue flesh smoothly, or when subjected to axial pressure later, the degradable valve frame 1 is deformed and detached from the tissue flesh, 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.

[0069] like Figure 1 and Figure 4 As shown, in an embodiment of the present application, the frame body 11, the proximal body 12 and / or the distal body 13 respectively include a plurality of lattice structures 14, and each lattice structure 14 is fully closed. By providing a fully closed lattice structure 14, each connection point can support each other, and the structural strength is high, which not only enables the overall supporting performance of the degradable valve frame 1 to meet the application requirements, but also enables the degradable valve frame 1 to achieve a uniform expansion effect under the mutual pulling action of each connection point when expanding. At the same time, the lattice structure 14 has empty holes inside, which can also reduce the usage of the overall material of the degradable valve frame 1 and improve the efficiency of degradation of the degradable valve frame 1. Specifically, the shape of the lattice structure 14 formed can be various forms, such as a regular polygon or a circle (such as Figure 1 The middle is a quadrilateral or Figure 4 It is a hexagon in the figure), or other irregular shapes, which has good setting flexibility. The shape of the lattice structure 14 is not limited here.

[0070] like Figure 1 and Figure 5 As shown, in a possible embodiment, the lattice structure 14 on the frame 11 can be set to include a crest 141 and a trough 142 (defined along the direction from the proximal body 12 to the distal body 13). That is, the lattice structure 14 is set to a regular-shaped wave structure. Each lattice structure 14 is evenly distributed in the circumferential direction of the frame 11, connected end to end and closed in the circumferential direction, so as to have a use requirement that at least meets the radial support performance. The lattice structure 14 with a regular shape can also be expanded when each lattice structure 14 is evenly stressed to achieve uniform expansion. Specifically, the angle α1 between two adjacent support rods 143 used to form the crest 141 or the trough 142 on the frame 11 is 50°-160°. Preferably, α1 can be 60°-140° or α1 can be 60°-120° or α1 can be 70°-110° or α1 can be 80°-100°.

[0071] Furthermore, if Figure 4 As shown, in a possible embodiment, the angle α2 between two adjacent support rods used to form the peak n1 or the 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°.

[0072] Specifically, the larger the angle formed by adjacent support rods on the same lattice structure 14, the less likely the corrugated structure is to be compressed, and the higher the radial support force is. However, if the angle is too large, the stent is subjected to greater forces at the wave crests and wave troughs, and is prone to expandable fractures or long-term fatigue fractures. In the present application, by setting the angle between the two support rods corresponding to each position within the above-mentioned corresponding numerical range, 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.

[0073] The degradable valve frame 1 provided by the present application has a total number of 12-48 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; further, the total number of support rods 143 is 12-36. The number of support rods 143 can be appropriately adjusted according to the number of blood vessel branches near the valve frame implantation and the magnitude of the radial force exerted on the valve frame by the tissue surrounding the valve frame. When there are branched blood vessels near the implantation position of the valve frame, according to the relative position between the branched blood vessels and the valve frame, the number of support rods 143 of the corresponding lattice structure 14 can be reduced, so that the mesh is as large as possible than the opening of the branched blood vessel, thereby avoiding blocking the opening of the blood vessel and preventing blood flow from being blocked at the branched blood vessel; when a part of the valve frame is subjected to a relatively small radial force of the surrounding tissue, the number of support rods 143 can also be appropriately reduced, so that the corresponding lattice structure 14 has sufficient mechanical properties and can also reduce the amount of valve frame material, thereby reducing the burden on material absorption and the time required for degradation. For example, 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 frame can be set to be less, such as 12. Generally, a larger mesh is formed in the distal body 13 to avoid blocking the opening of the branched blood vessels; in addition, the radial support force borne by both ends of the pulmonary valve is small, so not only the distal body 13 can be provided with fewer support rods 143, but also the proximal body 12 can be provided with fewer support rods 143.

[0074] 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, the smaller the coverage of the distal body 13 is set, the less material is used in the distal body 13. In this way, fewer products are generated during degradation, which is more conducive to improving the efficiency of degradation and absorption.

[0075] In the degradable valve frame 1 provided in the embodiment of the present application, the yield strength of the base material of the degradable valve frame 1 is 350-1450MPa; and / or the tensile strength of the base material of the degradable valve frame 1 is 400-1500MPa. Specifically, the base material 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 base material is a non-degradable material, and the degradable part mainly plays a connecting role. The yield strength of the base material of the degradable valve frame 1 refers to the yield strength of the non-degradable material. For the partially degradable valve frame 1, the higher the strength of the non-degradable material, the stronger the fracture resistance, which can reduce the risk of fracture caused by the long-term existence of the stent in the body. In other embodiments of the present application, when the degradable valve frame 1 is made entirely of degradable materials, the yield strength of the base material of the degradable valve frame 1 is the yield strength of the degradable material. The higher the yield strength or tensile strength of the base material, the less material the valve frame needs to use to achieve the corresponding support effect, which is more conducive to reducing the absorption burden in the patient's body.

[0076] The degradable valve frame 1 provided in the present application, the material of the degradable part substrate 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, polycaprolactide 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 (2R)-2-amino-3-(2-chloro-4-hydroxyphenyl)propionic acid methyl ester, D-tyrosine ethyl ester hydrochloride, (2R)-2-amino-3-(2,6-dichloro-3,4-dimethoxyphenyl)propionic acid methyl ester HD-Tyr(TBU)-allyl ester HCl, (2R)-2-amino-3-(3-chloro-4,5-dimethoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(2-chloro-3-hydroxy-4-methoxyphenyl)propionic acid methyl ester, (2R)-2-amino-3-(4-[(2-chloro-6-fluorophenyl)methoxy]phenyl)propionic acid methyl ester, (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. ;

[0077] 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.

[0078] It should be noted that the "certain alloy" in this application refers to the element contained in the alloy. For example, ferroalloy refers to the alloy containing iron, zinc alloy refers to the alloy containing zinc, and magnesium alloy refers to the alloy containing magnesium; further, "certain alloy" may refer to the alloy in which the mass or volume content of "certain 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, ferroalloy refers to an alloy in which the mass / volume content of iron in the alloy 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.

[0079] Pure metal in this application means that the total content of other impurities in the metal is less than or equal to 0.5wt.%. For example, pure iron means that the total amount of other metals and / or non-metals contained in it except iron is less than or equal to 0.5wt.%.

[0080] In the embodiment of the present application, by using the degradable valve frame 1 made of the above material, it can not only achieve degradation within a preset time, but also achieve the purpose of eliminating the limiting effect through degradation after implantation, and will not hinder re-implantation. Moreover, the degradable valve frame 1 made of the above material, combined with the above structural design, can also have good radial support performance. The radial support force it possesses can effectively support blood vessels and resist external pressure, and it will not collapse easily, and the support reliability is good. At the same time, the size of the support force will not cause difficulty in transportation and use, and it is convenient for compression and transportation, and the design is ingenious.

[0081] like Figure 1 and Figure 5As shown, in some possible embodiments, the lattice structure 14 is a regular polygon, such as any one of a quadrilateral, a hexagon, a heptagon, or an octagon, etc.; or the lattice structure 14 can also be an irregular polygon, as long as it can be evenly opened during expansion and can reliably provide support, the irregular polygon can be any shape. Of course, it can be understood that in other possible embodiments, each polygonal lattice structure 14 has both regular polygons and irregular polygons.

[0082] In some possible embodiments, the irregular polygons may be distributed at any position (on the proximal body 12, the distal body 13, and the frame body 11) of the degradable valve frame 1, such as the polygons on the proximal body 12 are irregular, and the polygons on other parts are regular; or the polygons on the distal body 13 are irregular, and the polygons on other parts are regular; or the polygons on the frame body 11 are irregular, and the polygons on other parts are regular. In some embodiments, the irregular polygons are non-uniformly distributed; or the irregular polygons are uniformly distributed; or the irregular polygons are distributed at more than one position of the proximal body 12, the distal body 13, and the frame body 11.

[0083] In the biodegradable valve frame 1 provided in the present application, along the direction from the proximal body 12 to the distal body 13, the wave crest 141 of the nth pore structure 14 on the frame body 11 is connected directly or through a first connecting rod (not shown in the figure) to the wave trough 142 of the n+1th pore structure 14, wherein n≥1. Figure 5 As shown, in the same direction of the frame 11, the connection between two adjacent lattice structures 14 can be direct connection. Figure 4 As shown, it can also be indirectly connected through the first connecting rod 111. The specific connection method can be flexibly selected according to the actual design requirements. The setting 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 the length of the first connecting rod 111 is too long, which will affect the structural strength of the frame 11. Therefore, setting the length of the first connecting rod 111 within the range of 0.10-3.0mm can achieve the purpose of increasing the length of the frame 11 without affecting the structural strength of the frame 11, and meet the use requirements of degradable valve frames 1 of different lengths.

[0084] It should be noted that the first connecting rod mentioned in the present application can be linear or non-linear, such as S-shaped, ω-shaped or Ω-shaped.

[0085] like Figure 5As shown, in the biodegradable 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 via the 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 also be directly connected or connected using the second connecting rod 15. The specific connection method can be selected according to actual design requirements. In the embodiment of the present application, Figure 5 As shown, 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 more easily bulge, expand into a cylinder or an outward-turned trumpet shape, thereby improving the reliability of positioning between the implanted tissue.

[0086] Specifically, the shape of the proximal body 12 can be set to be continuously bent into a closed ring with multiple corrugated structures. When the proximal body 12 and the frame body 11 are connected by setting a second connecting rod 15, one end of the second connecting rod 15 can be connected to the crest of the proximal body 12, and the other end can be connected to the adjacent trough 142 on the frame body 11. Moreover, the number of crests on the proximal body 12 is equal to the number of adjacent troughs 142 on the frame body 11, so that the adjacent crests and troughs 142 can be connected by the second connecting rod 15, or can be connected at intervals. The crests or troughs mentioned are based on the direction in which the petal frame 1 is vertical, the proximal body 12 is at the bottom, and the distal body 13 is at the top.

[0087] Further, 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, and the application range is wide. 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 not conducive to processing and manufacturing. 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.

[0088] like Figure 1 and Figure 5As shown, in some possible implementation schemes, the distal body 13 includes a first support body 131 and a second support body 132 connected to each other 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 connected to each other according to a preset shape, and the outer contour is "M" shaped, with two sawtooth-like top ends, and the heights of the two top ends 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.

[0089] like Figure 5 As shown, in some embodiments, the first support body 131 is bent to form a peak n1, and the second support body 132 is bent in the same direction to form a peak n2, and 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 both sides. The lower the height of the peak n2, the smaller the obstruction caused by the second support body, and the more conducive it is to avoid blocking the branch blood vessels at the distal end, thereby effectively preventing the blockage of the branch blood vessels. Of course, under the premise of meeting the use requirements, the height relationship between the peak n1 and the peak n2 can also be other range values.

[0090] like Figure 1 and Figure 5 As shown, in one embodiment, the distal body 13 further includes a reinforcing member 133, which is disposed between the frame body 11 and the distal body 13, and is connected to at least the first support body 131. The two ends of the reinforcing member 133 are respectively connected to the two side bars formed after the first support body 131 is bent, so that the two side bars can be reinforced, thereby playing a role in strengthening the axial support strength and radial support force of the first support body 131. In another embodiment, referring to Figure 6 , one end of the reinforcing member 133 can also be connected to the top of the wave crest n1 formed after the first support body 131 is bent, and the other end can be connected to any side rod or frame 11, which can also achieve the effect of supporting and reinforcing the first support body 131. In this way, the supporting force provided by the reinforcing member 133 can enhance the supporting performance of the distal body 13 and improve the reliability of use. In addition, the pulling or limiting of the reinforcing member 133 is also conducive to the full expansion of the first support body 131 after bending.

[0091] like Figure 7As shown, in some possible embodiments, the reinforcing member 133 is arranged closer to the apex of the wave crest n1, preferably connected in the area between the midpoint of the connected side bar and the apex of the wave crest n1. Generally, since the apex of each wave crest n1 is the first part to be stressed, placing the reinforcing member 133 closer to the apex can enhance the strength of the apex, thereby improving the deformation resistance of the entire distal body 13.

[0092] 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.

[0093] In some possible implementation schemes, the entirety of the degradable valve frame 1 is constructed of support rods of corresponding materials. With the midpoint of the frame body 11 as the starting point, the axial cross-sectional area of ​​the support rod can be gradually reduced in the direction toward the proximal body 12 and the distal body 13, respectively. That is, the axial cross-sectional area at the midpoint of the frame body 11 is the largest, and the axial cross-sectional area at the apex of the proximal body 12 and the distal body 13 is the smallest. Optionally, the rate of change of the gradual reduction of the axial cross-sectional area of ​​the support rod is set to 5%. In this way, the support rod itself will not be too thick or too thin, and the proximal body 12 and the distal body 13 use less material, which is convenient for degradation, especially in the part where the proximal body 12 and / or the distal body 13 are not attached to the blood vessel wall, the design with less material is conducive to improving the degradation efficiency. In addition, from the proximal body 12 to the frame body 11 and from the distal body 13 to the frame body 11, the axial cross-sectional area of ​​the support rod becomes larger and larger, so that the frame body 11 has a reliable axial support strength, so that the degradable valve frame 1 has good axial deformation resistance and is not easy to collapse.

[0094] In some possible implementation schemes, 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. Further, 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.

[0095] It should be noted that the "end" mentioned above refers to the general term for 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 of the degradable valve frame 1 to the minimum diameter of the middle is [1.1-1.8]:1" means "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; at the same time, 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.

[0096] Furthermore, the ratio of the maximum diameter of the proximal body 12 to the minimum diameter of the frame body 11 may be equal to or unequal to the ratio of the maximum diameter of the distal body 13 to the minimum diameter of the frame body 11. That is, the maximum diameter of the proximal body 12 may be equal to or unequal to the maximum diameter of the distal body 13.

[0097] Furthermore, the ratio of the maximum diameter of the proximal body 12 to the minimum diameter of the frame body 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 body 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 .

[0098] like Figure 1 As shown, the degradable valve frame 1 provided by the present application has a frame 11 having a length of 15%-75% of the total valve frame length; or a frame 11 having a length of 20%-65% of the total valve frame length. When the total length of the valve frame 1 is determined to be unchanged, frames 11 of different lengths will cause the lengths of the proximal body 12 and the distal body 13 to change. If the frame 11 is set longer, the length of the proximal body 12 and / or the distal body 13 will be shortened, and the angle of inclination of the entire valve frame from the frame 11 to the two ends will be larger; conversely, if the frame 11 is set shorter, the length of the proximal body 12 and / or the distal body 13 will be lengthened, and the angle of inclination of the entire valve frame from the frame 11 to the two ends will be smaller. 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 11 is designed within the above-mentioned numerical range to meet different design requirements.

[0099] like Figure 1 As shown, in the degradable valve frame 11 provided by the present application, the angle 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 is α3, and the angle 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 is α4, and the size of α3 or α4 is between (0°, 30°], wherein α3=α4, or α3≠α4, or α3 is less than α4.

[0100] 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°].

[0101] Further, in some embodiments of the present application, the angle α3 formed by the distal body 13 is the same as 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 not the same, that is, α3≠α4. Further, the angle α3 formed by the distal body 13 is less than or equal to the angle α4 formed by the proximal body 12.

[0102] In the embodiment of the present application, α3 and α4 are set to 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.

[0103] A heart valve is also provided in the embodiment of the present application, including leaflets and the above-mentioned degradable valve frame 1, and the leaflets are connected to the degradable valve frame 1. The heart valve uses 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 requirements of the heart valve not only effectively supporting blood vessels and maintaining the stability of the supporting position, but also with low difficulty in re-implantation operation. At the same time, the valve frame is completely degraded and absorbed by the body until it disappears completely, and will not remain in the body, avoiding the long-term safety hazards caused by the presence of multiple valve frames in the body.

[0104] The degradable valve frame 1 provided in the present application includes valve frames for mitral valve, tricuspid valve, aortic valve and pulmonary valve.

[0105] The degradable valve frame 1 provided in the present application can be directly sutured with the valve leaflets to form a complete valve for implantation in the body, or it can be used as an independent valve frame with another valve placed inside.

[0106] The range of values ​​of the interval X1-X2 in this application indicates that the value can be X1, X2, or any value within the interval of X1 and X2, that is, the interval is a closed interval. For example, if the "wall thickness of the bracket is 0.04mm-0.5mm" mentioned in this application, the wall thickness of the bracket can be 0.04mm, 0.5mm, or any value between 0.04-0.5mm.

[0107] In order to facilitate the understanding of the present application, the design points of the present application are described below in conjunction with some specific embodiments. It can be understood that the relevant embodiments are only some examples of the present application scheme and do not constitute a limitation on the scope of application.

[0108] Example 1

[0109] The present embodiment provides a degradable valve frame 1, the material of which is 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, the wall thickness of the support rods is 0.23 mm, and the coverage rate is 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 length of the frame 11 accounts for 15% of the total length of the petal frame. The two ends of the petal frame 1 are tilted. The diameter of the frame 11 is 20 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame 11 are both 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0110] The radial supporting force of the valve frame is 18kPa, the axial deformation resistance is 3.5N, and the parallel plate extrusion resistance is 0.2N / mm; it can be implanted into the pulmonary valve of a dog through an interventional method, and 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, the 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 taken out, and it can be seen that the first implanted valve frame had obviously degraded; the re-implanted valve frame was completely degraded in about three years.

[0111] Example 2

[0112] The present embodiment provides a degradable valve frame 1, the material is nitrided iron, the tensile strength is 950MPa, and the yield strength is 900MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.18mm, 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 angle 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 through a second connecting rod 15 with a length of 0.8mm. The length of the frame 11 accounts for 75% of the total petal frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 20 mm. 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°. 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1. The second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent. At the same time, the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0113] The radial supporting force of the valve frame is 30kPa, the axial deformation resistance is 2.1N, and the parallel plate extrusion resistance is 0.16N / mm; it can be implanted into the aortic valve of dogs through interventional methods, and 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, the second valve frame was implanted in situ, and the implantation process went smoothly. The valve frame was not restrained by the original stent during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was taken out, 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.

[0114] Example 3

[0115] The degradable valve frame 1 provided in this embodiment is specifically a zinc-based absorbable mitral valve stent, made of zinc alloy, with a tensile strength of 480MPa and a yield strength of 380MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.15mm, the coverage rate is 9.2%, and the coverage rate of the distal body 13 is 3.8%. The valve frame 1 is a fully closed design, with an angle α1 of 120° and an angle α2 of 65°. 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 0.8mm. The length of the frame 11 accounts for 65% of the total petal frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm. 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°. 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0116] The radial supporting force of the valve frame is 12kPa, the axial deformation resistance is 1.2N, and the parallel plate extrusion resistance is 0.10N / mm; it can be implanted in the mitral 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, the second valve frame was implanted in situ, and the implantation process went smoothly. During the expansion of the valve frame, it 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 taken out, 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.

[0117] Example 4

[0118] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable tricuspid valve stent, the material is nitrided iron, the tensile strength is 900MPa, and the yield strength is 830MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.15mm, the coverage rate is 8.0%, and the coverage rate of the distal body 13 is 2.4%. The stent is a fully closed design, the angle α1 is 160°, α2 is 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 through a second connecting rod 15 with a length of 0.8mm. The length of the frame 11 accounts for 75% of the total petal frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 18 mm. 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°. 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0119] The radial supporting force of the valve frame is 40kPa, the axial deformation resistance is 1.8N, and the parallel plate extrusion resistance is 0.18N / mm; it can be implanted in 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, the second stent was implanted in situ, and the implantation process went smoothly. The valve frame was not restrained by the original stent during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was taken out, 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.

[0120] Example 5

[0121] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable pulmonary valve stent, the material is nitrided iron, the tensile strength is 950MPa, and the yield strength is 900MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein the frame body 11 is connected by 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 0.35mm, the coverage rate is 13%, and the coverage rate of the distal body 13 is 5.5%. The stent is a fully closed design, the angle α1 is 100°, α2 is 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 through a second connecting rod 15 with a length of 1.5mm. The length of the frame 11 accounts for 20% of the total length of the valve frame. The two ends of the valve frame 1 are tilted. The diameter of the frame 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame 11 are both 1.3. 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 9°. The distal body 13 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0122] The radial supporting 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, 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; at 12 months, the second valve frame was implanted in situ, and the implantation process was smooth. When the valve frame expanded, it 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 taken out, 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.

[0123] Example 6

[0124] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable pulmonary valve stent, made of pure iron, with a tensile strength of 650MPa and a yield strength of 480MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.25mm, the coverage rate is 5.0%, and the coverage rate of the distal body 13 is 2.1%. The stent is a fully closed design, with an angle α1 of 90° and an angle α2 of 75°. 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 1.5mm. The length of the frame 11 accounts for 20% of the total length of the petal frame. The two ends of the petal frame 1 are tilted. The diameter of the frame 11 is 24mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame 11 are both 1.3. 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 9°. The distal body 13 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a crest n1, and the second support body 132 is bent to form a crest n2. The height of the crest n2 is 1 / 3 of the height of the crest n1. A reinforcing member 133 is arranged on the two side bars formed after the first support body 131 is bent. At the same time, the reinforcing member 133 is respectively connected between the midpoint of the length direction of the two side bars and the crest n1, and the support reliability is good.

[0125] The radial supporting force of the valve frame is 6kPa, the axial deformation resistance is 2.5N, and the parallel plate extrusion resistance is 0.12N / 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 distal branches; at 12 months, the second valve frame was implanted in situ, and the implantation process went smoothly. During the expansion of the valve frame, it was not restrained by the original valve frame, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was taken out, 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 and a half years.

[0126] Example 7

[0127] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable aortic valve stent, made of iron-manganese alloy, with a tensile strength of 1500MPa and a yield strength of 1450MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 48 support rods, the support rod wall thickness is 0.40mm, the coverage rate is 18%, and the coverage rate of the distal body 13 is 6%. The stent is a fully closed design, with an angle α1 of 140° and an angle 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 through a second connecting rod 15 with a length of 0.8mm. The length of the frame 11 accounts for 50% of the total petal frame length, the distal body 13 is tilted and flared, the diameter of the frame 11 is 16 mm, 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°, and the angle α4 between the line connecting the apex of the proximal body 12 and the midpoint of the middle part of the frame 11 and the central axis of the frame 11 is 0°. The distal body 13 includes a first support body 131 and a second support body 132, the first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2, and the height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0128] The radial supporting force of the valve frame is 140kPa, the axial deformation resistance is 6.5N, and the parallel plate extrusion resistance is 0.8N / mm; the valve frame can be implanted into the aortic valve of the 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; at 12 months, the second valve frame was implanted in situ, and the implantation process went smoothly. The valve frame was not restrained 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 taken out, and it can be seen that the first implanted valve frame has been significantly degraded, and the re-implanted valve frame is completely degraded in about five years.

[0129] Example 8

[0130] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable aortic valve stent, the material is nitrided iron, the tensile strength is 950MPa, and the yield strength is 900MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.35mm, the coverage rate is 15%, and the coverage rate of the distal body 13 is 5.8%. The stent is a fully closed design, the angle α1 is 120°, α2 is 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 through a second connecting rod 15 with a length of 0.8mm. The length of the frame 11 accounts for 50% of the total petal frame length, the distal body 13 is tilted and flared, the diameter of the frame 11 is 16 mm, 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°, 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 0°. The distal body 13 includes a first support body 131 and a second support body 132, the first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2, and the height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0131] The radial support force of the valve frame is 120kPa, the axial deformation resistance is 5.2N, and the parallel plate extrusion resistance is 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, the second valve frame was implanted in situ, and 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 taken out, 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 four and a half years.

[0132] Example 9

[0133] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable mitral valve stent, the material is nitrided iron, the tensile strength is 800MPa, and the yield strength is 720MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.35mm, the coverage rate is 13%, and the coverage rate of the distal body 13 is 5.5%. The stent is a fully closed design, the angle α1 is 110°, α2 is 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 through a second connecting rod 15 with a length of 0.8mm. The length of the frame 11 accounts for 35% of the total petal frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm. 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°. 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0134] The radial supporting 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 the 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; at 12 months, the second valve frame was implanted in situ, and the implantation process was smooth. When the valve frame expanded, 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 taken out, 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.

[0135] Example 10

[0136] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable tricuspid valve stent, the material is nitrided iron, the tensile strength is 900MPa, and the yield strength is 830MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.38mm, the coverage rate is 14%, and the coverage rate of the distal body 13 is 5.2%. The stent is a fully closed design, the angle α1 is 70°, α2 is 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 through a second connecting rod 15 with a length of 0.8mm. The length of the frame 11 accounts for 75% of the total petal frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm. 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°. 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0137] The radial supporting force of the valve frame is 110kPa, the axial deformation resistance is 5.8N, and the parallel plate extrusion resistance is 0.5N / mm; it can be implanted in 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, the second valve frame was implanted in situ, and the implantation process went smoothly. During the expansion of the valve frame, it was not restrained by the original valve frame, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was taken out, 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 four and a half years.

[0138] Embodiment 11

[0139] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable pulmonary valve stent, the material is nitrided iron, the tensile strength is 750MPa, and the yield strength is 850MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 12 support rods, with a coverage rate of 4.0%, and the midpoint of the frame body 11 is the starting point, and the wall thickness of the support rod at the midpoint is 0.25mm along the direction toward the proximal body 12 and the distal body 13, and the wall thickness of the support rod at both ends gradually decreases to 0.15mm. The angle between the line connecting the vertex of the proximal body 12 or the distal body 13 and the midpoint of the frame body 11 and the axis of the support rod is 0.4°. The coverage rate of the distal body 13 is 1.5%. The stent is a fully closed design, with an angle α1 of 90° and an angle α2 of 75°. 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 3.5 mm. The length of the frame body 11 accounts for 20% of the total valve frame length. The two ends of the valve frame 1 are tilted, the diameter of the frame body 11 is 16 mm, and the maximum diameter ratio of the proximal body 12 and the distal body 13 to the frame body 11 is 1.2. The angle 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 is α3, and the angle 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 is α4, and both α3 and α4 are 8°. The distal body 13 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a crest n1, and the second support body 132 is bent to form a crest n2. The height of the crest n2 is 1 / 2 of the height of the crest n1. A reinforcement member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcement members 133 are respectively connected to the midpoints of the length direction of the two side bars.

[0140] The radial supporting force of the valve frame is 12kPa, the axial deformation is 2.7N, and the anti-parallel plate extrusion force is 0.22N / 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 distal branches; at 12 months, the second valve frame was implanted in situ, and the implantation process went smoothly. During the expansion of the valve frame, it 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 taken out, 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 four years.

[0141] Example 12

[0142] The degradable valve frame 1 provided in this embodiment is specifically a magnesium-based absorbable pulmonary valve stent with a tensile strength of 400MPa and a yield strength of 350Mpa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13. The frame body 11 and the proximal body 12 are made of magnesium alloy, and the distal body 13 is made of cobalt-chromium alloy material and magnesium alloy material. The magnesium alloy only constitutes part of the support rod, which mainly plays a connecting role and accounts for 5% of the distal body. The rest is cobalt-chromium alloy material, and the distal end accounts for 10%, that is, 90.5% of the stent is degradable. The frame body 11 is connected by 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 0.23mm, the coverage rate is 6.2%, and the coverage rate of the distal body 13 is 2.2%. The stent is a fully closed design, with an angle α1 of 160° and an angle α2 of 179°. 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 3.5 mm. The length of the frame body 11 accounts for 20% of the total valve frame length. The two ends of the valve frame 1 are tilted, the diameter of the frame body 11 is 20 mm, and the maximum diameter ratio of the proximal body 12 and the distal body 13 to the frame body 11 is 1.2. The angle 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 is α3, and the angle 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 is α4, and both α3 and α4 are 8°. The distal body 13 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a crest n1, and the second support body 132 is bent to form a crest n2. The height of the crest n2 is 1 / 2 of the height of the crest n1. A reinforcement member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcement members 133 are respectively connected to the midpoints of the length direction of the two side bars.

[0143] The radial supporting force of the valve frame is 10kPa, the axial deformation resistance is 1.8N, and the parallel plate extrusion resistance is 0.1N / mm; it can be implanted in 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 the blood vessel wall; at 12 months, the second valve frame was implanted in situ, and 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 taken out, and it can be seen that the frame body 11 and the proximal body 12 in the valve frame 1 implanted for the first time have been significantly degraded, and the distal body 13 has also been completely disassembled.

[0144] Example 13

[0145] The present embodiment provides a degradable valve frame 1, specifically a pulmonary valve frame, the main material of which is a non-degradable cobalt-chromium alloy with a tensile strength of 1500MPa and a yield strength of 1450MPa. 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. The frame body 11 is formed by a plurality of lattice structures connected together, and each lattice structure in the same circumferential direction is formed by a total of 36 support rods, the wall thickness of the support rod is 0.23mm, and the coverage rate is 6.6%. Figure 3 As shown, some of the support rods in the valve frame 1 are not continuous, but 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 is a fully closed design, with an angle 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 through a second connecting rod 15 with a length of 3.5 mm. The length of the frame 11 accounts for 20% of the total valve frame length. The two ends of the valve frame 1 are raised, the diameter of the frame 11 is 20 mm, and 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 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, and both α3 and α4 are 8°. The distal body 13 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a crest n1, and the second support body 132 is bent to form a crest n2. The height of the crest n2 is 1 / 2 of the height of the crest n1. A reinforcement member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcement member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0146] The radial supporting force of the valve frame is 45kPa, the axial deformation resistance is 4.2N, and the parallel plate extrusion resistance is 0.18N / mm; it can be implanted into the pulmonary valve of a dog through an interventional method, and 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 branches; at 12 months, the second valve frame was implanted in situ, and 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 taken out, and it can be seen that the connecting rod 110 in the valve frame 1 implanted for the first time has been degraded and the stent has been disassembled.

[0147] Embodiment 14

[0148] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable pulmonary valve stent, the material is nitrided iron, the tensile strength is 950MPa, and the yield strength is 900MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein the frame body 11 is connected by 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 0.15mm, the coverage rate is 10%, and the coverage rate of the distal body 13 is 5%. The stent is a fully closed design, the angle α1 is 110°, α2 is 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 through a second connecting rod 15 with a length of 3.5mm. The length of the frame 11 accounts for 20% of the total length of the petal frame. The two ends of the petal frame 1 are tilted. The diameter of the frame 11 is 20 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the frame 11 are both 1.3. 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0149] The radial supporting 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, 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; at 12 months, the second valve frame was implanted in situ, and the implantation process was smooth. When the valve frame expanded, it 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 taken out, 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.

[0150] Embodiment 15

[0151] The present embodiment provides a degradable valve frame 1, the material is nitrided iron, the tensile strength is 950MPa, and the yield strength is 900MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.3mm, 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 angle 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 through a second connecting rod 15 with a length of 0.8mm. The length of the frame 11 accounts for 75% of the total petal frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 20 mm. 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°. 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0152] The radial support force of the valve frame is 50kPa, the axial deformation resistance is 3N, and the parallel plate extrusion resistance is 0.23N / mm; it can be implanted into the aortic valve of a dog through an interventional method, and 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, the second valve frame was implanted in situ, and the implantation process went smoothly. The valve frame was not restrained by the original stent during expansion, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was taken out, 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.

[0153] Example 16

[0154] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable mitral valve stent, the material is nitrided iron, the tensile strength is 900MPa, and the yield strength is 800MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.18mm, the coverage rate is 5%, and the distal body 13 coverage rate is 2%. The valve frame 1 is a fully closed design, the angle α1 is 100°, α2 is 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 through a second connecting rod 15 with a length of 0.8mm. The length of the frame 11 accounts for 50% of the total petal frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm. 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°. 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0155] The radial supporting force of the valve frame is 30kPa, the axial deformation resistance is 1.8N, and the parallel plate extrusion resistance is 0.18N / mm; it can be implanted in the mitral 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, the second valve frame was implanted in situ, and the implantation process went smoothly. During the expansion of the valve frame, it 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 taken out, 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.

[0156] Embodiment 17

[0157] The degradable valve frame 1 provided in this embodiment is specifically an iron-based absorbable tricuspid valve stent, the material is nitrided iron, the tensile strength is 900MPa, and the yield strength is 830MPa. The degradable valve frame 1 includes a frame body 11, a proximal body 12 and a distal body 13, wherein 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 0.18mm, the coverage rate is 5%, and the coverage rate of the distal body 13 is 2%. The stent is a fully closed design, the angle α1 is 90°, α2 is 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 through a second connecting rod 15 with a length of 0.8mm. The length of the frame 11 accounts for 60% of the total petal frame length. The distal body 13 is tilted and flared. The diameter of the frame 11 is 16 mm. 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°. 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 includes a first support body 131 and a second support body 132. The first support body 131 is bent to form a wave crest n1, and the second support body 132 is bent to form a wave crest n2. The height of the wave crest n2 is 1 / 2 of the height of the wave crest n1. A reinforcing member 133 is provided on the two side bars formed after the first support body 131 is bent, and the reinforcing member 133 is respectively connected to the midpoints of the length direction of the two side bars.

[0158] The radial supporting force of the valve frame is 30kPa, the axial deformation resistance is 2N, and the parallel plate extrusion resistance is 0.2N / mm; it can be implanted in 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, the second valve frame was implanted in situ, and the implantation process went smoothly. During the expansion of the valve frame, it was not restrained by the original valve frame, and the blood vessel could still be expanded to the expected diameter. After that, the valve frame was taken out, 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 four and a half years.

[0159] 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.

[0160] Comparative Example 1

[0161] 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.

[0162] The radial supporting force of the stent is 45kPa, the axial deformation resistance is 3.8N, and the parallel plate extrusion resistance is 0.26N / mm; the stent can be implanted into the pulmonary valve of a dog through an interventional method, and 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; a second stent was implanted in situ at 12 months. When the stent was expanded, the first stent was not deconstructed, causing restraint, making it difficult for the second implanted stent 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.

[0163] Comparative Example 2

[0164] The design of the pulmonary valve stent in this comparative example is substantially 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 of the frame body 11 is 2.1%, and the coverage of the distal body 13 is 0.8%.

[0165] The radial support force of the stent under this design is 4kPa, the axial deformation resistance is 0.2N, and the anti-parallel plate extrusion force is 0.03N / mm; when the stent is implanted into the aortic valve of a dog through interventional methods, the radial support force, axial deformation force and anti-parallel plate extrusion force are too low, and the stent is crushed by the blood vessel and cannot effectively support the blood vessel. When the stent is taken out, it is found that the stent is flattened and axially deformed.

[0166] Comparative Example 3

[0167] The design of the pulmonary valve stent in this comparative example is substantially 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 of the frame body 11 is 20%, and the coverage of the distal body 13 is 8%.

[0168] The radial support force of the stent under this design is 160kPa, the axial deformation resistance is 8.2N, and the anti-parallel plate extrusion force is 1.1N / mm; when the stent is implanted into the pulmonary valve of the dog through interventional methods, 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 branches. However, the stent wall thickness is too thick and the coverage rate is too high. When the second valve frame was implanted in situ at 12 months, the expansion of the valve frame was restrained, and the blood vessel could not be fully 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 obvious degradation, but 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 implantation of the stent.

[0169] The above is only a preferred specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by any technician familiar with the technical field within the technical scope disclosed in the present application should be included in the protection scope 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; or the wall thickness of the degradable valve frame is 0.15mm-0.40mm; or 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 claim 1, characterized in that: The yield strength of the degradable valve frame substrate is 350MPa-1450MPa; and / or the tensile strength of the degradable valve frame substrate is 400MPa-1500MPa.

15. The degradable valve frame according to claim 1, characterized in that: The material of the degradable part of the degradable 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 polyanhydride comprises at least one of poly-1,3-bis(p-carboxyphenoxy)propane-sebacic acid, poly-erucic acid dimer-sebacic acid or poly-fumaric acid-sebacic acid; or the non-metal comprises at least one of a degradable polyamino acid or a degradable tyrosine-derived polymer, wherein the degradable polyamino acid comprises 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-OMEHCl, 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. ; 16. The degradable valve frame according to claim 1, 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.

17. The degradable valve frame according to claim 16, characterized in that: The length of the second connecting rod is 0.8 mm-4.0 mm.

18. The degradable valve frame according to any one of claims 1 to 17, characterized in that: The axial deformation resistance of the degradable valve frame is not less than 0.3N; or the axial deformation resistance of the degradable valve frame is not less than 1N.

19. The degradable valve frame according to any one of claims 1 to 17, characterized in that: The length of the frame is 15%-75% of the total valve frame length; or the length of the frame is 20%-65% of the total valve frame length.

20. The degradable valve frame according to any one of claims 1 to 17, 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.

21. A heart valve, characterized in that: It comprises a valve leaflet and a degradable valve frame as claimed in any one of claims 1 to 20, wherein the valve leaflet is connected to the degradable valve frame.

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