A valve frame for a pulmonary valve and a pulmonary valve

Abstract

The application belongs to the technical field of interventional medical instruments, and particularly relates to a valve frame for a pulmonary valve and a pulmonary valve. The valve frame comprises a tubular middle part, a proximal end part and a distal end part connected to the axial two ends of the middle part respectively, the middle part comprises a plurality of grid structures, the distal end part comprises a plurality of unit bodies with an 'M' shape, and the number of the unit bodies is m, m is a natural number greater than or equal to 2. The pulmonary valve comprises a valve leaflet and the valve frame, and the valve leaflet is connected to the valve frame. The valve frame provided by the application can be uniformly expanded, and the overall shape is consistent. The pulmonary valve can be uniformly expanded by adopting the valve frame, and the use requirement that the pulmonary valve can be uniformly expanded is well met, and the use reliability is good.

Description

Technical Field

[0001] This application belongs to the field of interventional medical device technology, specifically relating to a pulmonary valve stent and a pulmonary valve. Background Technology

[0002] Residual pulmonary valve regurgitation (PR) is a common long-term complication in patients with complex congenital heart disease with pulmonary ischemia (such as tetralogy of Fallot and pulmonary atresia) after their initial corrective surgery. This is especially true after transring patch repair. Severe PR can cause aneurysmal dilatation and dysfunction of the right ventricular outflow tract (RVOT), aneurysmal dilatation of the pulmonary artery, ventricular systolic dyssynchrony and arrhythmias, progressive right ventricular dilatation / dysfunction, and subsequent right heart failure, ultimately leading to heart failure and death. In recent years, the significance of pulmonary valve reconstruction has been increasingly recognized. Traditional surgical pulmonary valve replacement requires re-opening the chest and is performed under cardiopulmonary bypass. Transcatheter pulmonary valve replacement (TPVR), a minimally invasive surgical procedure that has gradually emerged since its first report by Bonhoeffer et al. in 2000, can replace surgical pulmonary valve replacement and improve the long-term prognosis of these patients. Transcatheter pulmonary valve replacement (TPVR) uses a pulmonary valve stent for replacement. A pulmonary valve stent generally consists of a stent supporting the blood vessel and a valve to replace the original pulmonary valve. The valve is implanted into the pulmonary valve location through a percutaneous interventional procedure using the stent.

[0003] Transcatheter pulmonary valve (TPV) deployment methods can be divided into two types: balloon dilation and self-expanding dilation. Currently, most commercially available valves are self-expanding. The valve is placed in a carrier catheter and implanted percutaneously. Once the valve reaches the appropriate position, it is released, and the valve frame structure itself secures the valve to the corresponding valve annulus. However, balloon-expanding stents do not automatically expand after reaching the appropriate position; they require balloon dilation and the interaction between the stent's support struts to expand. Therefore, designing a valve that can expand uniformly under balloon dilation while meeting the requirements of pulmonary valve applications presents a significant challenge. Summary of the Invention

[0004] Based on this, the present invention provides a valve frame for pulmonary valves, which can not only meet the requirements of pulmonary valves, but also expand uniformly and has good reliability in use.

[0005] The first aspect of this application proposes a valve frame for a pulmonary artery valve, comprising a tubular central body, and a proximal body and a distal body respectively connected to the two axial ends of the central body. The central body includes multiple mesh structures, and the distal body includes multiple unit cells with an "M"-shaped outline, wherein the number of the unit cells is m, and m is a natural number greater than or equal to 2.

[0006] In some examples, according to claim 1, the petal frame is characterized in that the unit body includes a first support and a second support connected at one end to each other, and the end of the first support and the second support connected to each other is connected to the central body.

[0007] In some examples, a "W"-shaped opening is formed between two adjacent units, and the area of ​​a single opening is ≥10% of the area of ​​the region formed by the distal body and the combination of the openings.

[0008] In some examples, the first support is bent to form a crest n1, and the second support is bent in the same direction to form a crest n2. The height of the crest n2 of the second support is less than or equal to 2 / 3 of the height of the crest n1 of the two adjacent first supports.

[0009] In some examples, the grid structure consists of crests, troughs, and support rods connecting the crests and troughs, with one end of the first support and the second support connected to the adjacent crest.

[0010] In some examples, the width of the first support is 1.0 to 3.5 times the width of the second support.

[0011] In some examples, the unit body further includes a reinforcing member disposed between the middle body and the distal body, the reinforcing member being at least connected to the first support body.

[0012] In some examples, the total outer surface area of ​​each of the first supports accounts for ≤2.5% of the cylindrical side surface area enclosed by the assembly of each unit body, and the total outer surface area of ​​each of the reinforcements accounts for ≤2.0% of the cylindrical side surface area enclosed by the assembly of each unit body.

[0013] In some examples, the reinforcement has a bend that is connected to the adjacent crest on the central body.

[0014] In some examples, the included angle formed by the bending of the first support is [40°, 110°] and / or the included angle formed by the bending of the second support is [40°, 179°].

[0015] In some examples, the ratio of the maximum diameter of the proximal body and / or the distal body to the minimum diameter of the middle body is (1-1.8):1.

[0016] In some examples, the middle body has a waist with a uniform diameter, and a connecting portion extending from the edge of the waist toward the proximal body and / or the distal body, with the diameter gradually increasing, the proximal body and the distal body being connected to the corresponding connecting portion.

[0017] In some examples, the length of the waist is 15%-60% of the total valve frame length; or the length of the waist is 20%-40% of the total valve frame length.

[0018] In some examples, the angle between the line connecting the vertex of the distal body and the midpoint of the waist and the central axis of the middle body is α1, and the angle between the line connecting the vertex of the proximal body and the midpoint of the waist and the central axis of the middle body is α2. The magnitude of α1 or α2 is between (0°, 30°), where α1 = α2, or α1 ≠ α2, or α1 is less than α2.

[0019] In some examples, the proximal body includes a third support formed in a predetermined shape, which is connected to the crests of an adjacent portion or all of the mesh structure.

[0020] In some examples, the proximal body further includes a connecting rod, through which the third support is connected to the crest of the mesh structure.

[0021] In some examples, the length of the connecting rod is 0.8mm-4mm.

[0022] In some examples, the radial support force of the middle body is [6kPa, 140kPa], the radial support force of the proximal body is [6kPa, 120kPa], the radial support force of the distal body is [6kPa, 100kPa], and the deformation resistance of the distal body is greater than or equal to 1.5N.

[0023] In some examples, the substrate of the petiole frame is made of a biodegradable material, and / or the substrate of the petiole frame is made of at least one of pure iron, iron alloy, pure magnesium, magnesium alloy, pure zinc, or zinc alloy.

[0024] A second aspect of this application provides a pulmonary artery valve, comprising leaflets and the aforementioned valve frame, wherein the leaflets are connected to the valve frame.

[0025] This application provides a pulmonary valve frame and a pulmonary valve. The valve frame includes a central body, a proximal body, and a distal body, with the proximal and distal bodies connected to the two ends of the central body. The central body has multiple grid structures. The distal body is configured as multiple "M"-shaped units, each connected to the central body. This configuration allows the valve frame to expand uniformly during expansion. The "M"-shaped units provide tension at the connection points and constrain the expansion path, while the grid structures also contribute to the tension and constraint. This results in good overall shape consistency. Using this valve frame, the pulmonary valve can expand uniformly, effectively meeting the requirement for uniform expansion and demonstrating high reliability. Attached Figure Description

[0026] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. Wherein:

[0027] Figure 1 This is a schematic diagram of the expanded valve frame structure provided in an embodiment of this application;

[0028] Figure 2 A schematic diagram of a planar structure of a petiole frame in a compressed state, provided in an embodiment of this application;

[0029] Figure 3 This is an exploded view of the expanded valve frame provided in an embodiment of this application;

[0030] Figure 4 This is a schematic diagram of the structure of the unit body provided in the embodiments of this application;

[0031] Figure 5 This is a partial structural diagram of the distal body provided in an embodiment of this application. Detailed Implementation

[0032] Exemplary embodiments of this application will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of this application are shown in the drawings, it should be understood that this application may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of this application and to fully convey the scope of this application to those skilled in the art.

[0033] It should be noted that the symbol " / " in this application represents "or", such as "A / B" means "A or B", and "A and / or B" means "A and B, or A or B".

[0034] The term “approximately” or “substantially” used with respect to a quantity includes variations of the listed quantity that are equivalent to the listed quantity, such as quantities that are not significantly different from the listed quantity used for the intended purpose or function.

[0035] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would 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 may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0036] Test method:

[0037] radial support force of the bracket

[0038] In this invention, a radial support force tester manufactured by Blockwise is used to test the radial support force in the following manner:

[0039] After the stent is expanded to its rated diameter D, due to the flared end of the stent, the entire stent is first compressed to the middle diameter. Then, the middle body, proximal body, and distal body are cut off separately. The part of the stent to be tested is placed in a radial support force tester to simulate the actual stress state of the stent in the blood vessel. The stent is compressed and deformed under the action of the pressure head. The pressure on the stent is measured when the diameter of the stent is reduced to 90% of the rated diameter D during the radial compression process.

[0040] like Figure 1 and Figure 2As shown in the embodiment of this application, a valve frame 1 for a pulmonary valve includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is constructed as a hollow tubular structure according to usage requirements, and can be selected as a structure with a circular axial cross-section. The hollow channel inside the central body 11 is used for blood flow. Of course, it is understood that the central body 11 can also be constructed into other shapes such as hexagonal or octagonal according to usage requirements. The proximal body 12 and the distal body 13 are respectively connected to the two ends of the central body 11 along the axial direction. The proximal body 12 and the distal body 13 are defined as follows: with the distance between the entire valve frame 1 and the heart after it is implanted in the living body as a reference, the end closer to the heart is the proximal body 12, and the end farther from the heart is the distal body 13. To achieve the supporting function, the central body 11 is configured to include multiple grid structures 111. After being expanded, each grid structure 111 can form a large supporting surface, thereby achieving the function of supporting the internal tissue of the implanted blood vessel.

[0041] like Figure 3 and Figure 4 As shown in the embodiment of this application, the distal body 13 is configured as multiple unit bodies 131 with an outline similar to an "M" shape. Each unit body 131 is connected end to end to form a closed structure, and each unit body 131 is connected to the middle body 11 (see [link]). Figure 1 With this configuration, during the expansion of the petal frame 1, the "M"-shaped unit 131 can achieve the tension of each connection point and the self-constraint of shape deformation during expansion. Combined with the tensioning and constraining effects of each grid structure 111 during expansion, the entire petal frame 1 can expand uniformly with good overall shape consistency, effectively meeting the usage requirements of the petal frame 1. The outline of the unit 131 is "M"-shaped, which is the shape presented when the distal end 13 of the petal frame 1 is placed vertically upwards. If the distal end 13 of the petal frame 1 is placed vertically downwards, the shape presented is "W". That is, the visually presented shape of the unit 131 may differ depending on the placement method. For ease of understanding, in this embodiment, the unit 131 is described as "M"-shaped with the distal end 13 of the petal frame 1 placed vertically upwards.

[0042] Because there are some vascular branches near the pulmonary valve, the distal end of the valve frame 1 needs to be designed to be relatively sparse to avoid blocking the branch vessels. In this embodiment, the number of unit cells 131 is set to m, where m is a natural number greater than or equal to 2, such as 2, 3, 4, 5, etc. Different combinations of different numbers of unit cells 131 can achieve different support areas. For example, the larger the value of m, the more unit cells 131 there are, and the smaller the mesh of the valve frame 1 is; conversely, the smaller the value of m, the fewer unit cells 131 there are, and the sparser the mesh of the valve frame 1 is. Therefore, the specific number of unit cells 131 can be set according to different application situations.

[0043] It should be noted that the distal body in this application embodiment can be composed of m “M” unit bodies, or it can be composed of m “M” unit bodies and other shapes, including but not limited to “V” shape.

[0044] Specifically, the valve frame 1 in this application is a balloon-expandable valve frame. A balloon is placed inside the frame, and by inflating or adding fluid to the balloon, it gradually expands. The valve frame 1 expands outward with the force generated by the balloon's expansion. During expansion, the connection points can pull on each other, and the self-constraint of the shape deformation during expansion ensures uniform force distribution and synchronous deformation, achieving uniform expansion and preventing uneven expansion in certain areas that could lead to ineffective blood vessel support. The expanded valve frame 1 has a uniform shape and good consistency, improving its reliability.

[0045] The petal frame 1 provided in this embodiment employs a method where the distal body 13 is configured as multiple "M"-shaped unit bodies 131, and the middle body 11 is provided with multiple grid structures 111, with each unit body 131 connected to the middle body 11. This configuration allows the petal frame 1 to expand uniformly and with good overall shape consistency during expansion. The "M"-shaped unit bodies 131 effectively stretch the connection points and constrain the expansion path, while the grid structures 111 also provide stretching and constraint during expansion.

[0046] like Figure 2 and Figure 4As shown, in some embodiments, unit 131 includes a first support 1311 and a second support 1312 connected at one end, and the end connecting the first support 1311 and the second support 1312 is connected to the central body 11. Specifically, unit 131 is constructed by connecting the first support 1311 and the second support 1312 to each other according to a preset shape, with an "M"-shaped outline and two serrated tips. The heights of the two tips may be the same or unequal. The first support 1311 and the second support 1312 can be the same rod-shaped component, forming a bent "M"-shaped unit 131; or they can be formed by splicing different rod-shaped components together. The interiors of the two tips are through holes for blood to pass through. Of course, it is understandable that, provided that the outer contour of the unit 131 is “M” shaped and the coverage of the formed petal frame 1 meets the requirements for reasonable use, the number of the first support 1311 and / or the second support 1312 and the shape formed by their combination are not limited here.

[0047] like Figure 3 and Figure 5 As shown in this embodiment, a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area of ​​a single opening 132 is ≥10% of the area formed by the combination of the distal body 13 and each opening 132. Specifically, the "W"-shaped opening 132 between two adjacent unit bodies 131 refers to the area formed between the first support 1311 in the first unit body 131 and the first support 1311 in the adjacent unit body 131 when the distal body 13 of the petiole frame 1 is placed vertically upwards. This area also contains the second support 1312 in the first unit body 131, so the overall outline of the combined opening 132 area is roughly "W"-shaped. A region is defined as formed by the combination of the distal body 13 and multiple openings 132, where the area of ​​each opening 132 is ≥10% of the area of ​​this region. This configuration not only ensures that the overall support strength of the petiole frame 1 is within a suitable range, but also reduces the overall material usage of the distal body 13, achieving a suitable coverage rate.

[0048] like Figures 3 to 4As shown, in some embodiments, the first support 1311 is bent to form a crest n1, and the second support 1312 is bent in the same direction to form a crest n2. The height of the crest n2 of the second support 1312 is less than or equal to 2 / 3 of the height of the crest n1 of the two adjacent first supports 1311. Further, the height of the crest n2 of the second support 1312 is less than or equal to 1 / 2 of the height of the crest n1 of the two adjacent first supports 1311. The lower the height of the crest n2, the larger the "W"-shaped opening 132, which is more conducive to avoiding obstruction of the distal pulmonary artery branches, thereby effectively preventing blockage of the branches. Of course, provided that the usage requirements are met, the height relationship between the crests n1 and n2 can also be other range values.

[0049] The structural design of the distal body 13 in the valve frame 1 described above can not only ensure the uniformity of the distal body 13 and even the entire valve frame 1 during and after balloon expansion, but also ensure that the distal body 13 has sufficient axial support, so as to stably fix it in the tissue in contact with the distal body 13, prevent the valve frame 1 from shifting, and thus improve the fixation effect of the valve frame 1.

[0050] like Figure 4 and Figure 5 As shown, in the pulmonary valve stent 1 provided by the above technical solution, the area of ​​the crest n2 in the middle of the "W"-shaped opening 132 is less than or equal to 1 / 3 of the area of ​​the two adjacent crests n1; furthermore, the area of ​​the crest n2 in the middle of the "W"-shaped opening 132 is less than or equal to 1 / 4 of the area of ​​the two adjacent crests n1. The coverage area of ​​crest n1 cannot be too small, otherwise it will not be easy for the balloon to expand evenly, while if the coverage area of ​​crest n1 is too large, it will easily make the height of the "W"-shaped opening 132 too small, which may easily block the opening 132 of the branch vessels.

[0051] like Figure 2 and Figure 3As shown in this embodiment, the mesh structure 111 is configured as consisting of crests 1111, troughs 1112, and support rods 1113 connecting the crests 1111 and troughs 1112. That is, the mesh structure 111 is a regularly shaped wave structure. Each mesh structure 111 is evenly distributed in the circumferential direction of the central body 11, connected end-to-end and closed in the circumferential direction, thus providing support performance that meets usage requirements. The regularly shaped mesh structure 111 ensures that each mesh structure 111 experiences uniform force during expansion, achieving uniform expansion. Simultaneously, one end of the first support body 1311 and the second support body 1312 is connected to the adjacent crest 1111. Thus, during expansion, the first support body 1311 and the second support body 1312 can generate tensile force in the axial direction, thereby achieving mutual tension between the interconnected mesh structures 111, the first support body 1311, and the second support body 1312, guiding expansion deformation, and further improving the uniformity of expansion.

[0052] According to the valve frame 1 provided by the above technical solution, the width of the first support 1311 is 1.0-3.5 times the width of the second support 1312, and / or the thickness of the first support 1311 is 1.0-3.5 times the thickness of the second support 1312. Furthermore, the width of the first support 1311 is 1.3-3 times the width of the second support 1312, and / or the thickness of the first support 1311 is 1.3-3 times the thickness of the second support 1312; even further, the width of the first support 1311 is 1.5-2.5 times the width of the second support 1312, and / or the thickness of the first support 1311 is 1.5-2.5 times the thickness of the second support 1312. In some embodiments of the present invention, the radial or axial support force of the wave crest n1 can be increased by increasing the width of the first support body 1311; in other embodiments of the present invention, the radial or axial support force of the wave crest n1 can be increased by increasing the thickness of the first support body 1311; in still other embodiments of the present invention, the radial or axial support force of the wave crest n1 can be increased by simultaneously increasing both the width and thickness of the first support body 1311. In this embodiment, the width of the support rod 1113 is set to 0.15-0.5 mm, preferably 0.18-0.4 mm; and the thickness is set to 0.15-0.40 mm, preferably 0.18-0.35 mm.

[0053] like Figure 4 and Figure 5As shown, in one embodiment, the unit body 131 further includes a reinforcing member 1313, which is disposed between the middle body 11 and the distal body 13. The reinforcing member 1313 is at least connected to the first support body 1311. In actual design, to increase the area of ​​the orifice for blood flow in the distal body 13, the height of the crest n1 formed by bending the first support body 1311 is usually larger, so as to form a larger orifice for blood flow without obstruction. At the same time, to reduce the coverage of the first support body 1311, the width and thickness of the first support body 1311, or the rod diameter of the first support body 1311, are usually designed to be as small as possible. Considering the overall reliability of the support performance of the distal body 13, the reinforcing member 1313 is provided to support and reinforce the crest n1. The reinforcing member 1313 is usually a rod-shaped structure, and its material, shape, and size may be the same as the material of the first support body 1311, or it may be omitted according to the usage requirements. The reinforcing member 1313 is connected to at least the first support body 1311. The connection can be made at any point on the first support body 1311 requiring reinforcement. The connection method can be as follows: the reinforcing member 1313 can be connected in parallel to the point requiring reinforcement on the first support body 1311, providing localized reinforcement; or both ends of the reinforcing member 1313 can be connected to the two side bars formed after bending the first support body 1311, thereby strengthening the axial and radial support strength of the wave crest n1; or one end of the reinforcing member 1313 can be connected to the apex of the wave crest n1 formed after bending the first support body 1311, and the other end can be connected to any of the side bars, also achieving the effect of supporting and reinforcing the wave crest n1. In this way, the supporting force provided by the reinforcing member 1313 enhances the support performance of the distal body 13 and improves its reliability. In addition, the reinforcement 1313 is provided at the two sides and / or apex of the crest n1, which can not only enhance the axial or radial support force of the first support 1311, which is beneficial to the fixation of the valve and the prevention of displacement, but also facilitate the full expansion of the two side rods formed after the first support 1311 is bent.

[0054] like Figure 4 and Figure 5As shown, according to the reinforcement 1313 provided by the above technical solution, provided that the petal frame 1 meets the usage requirements such as coverage and overall weight, the number of reinforcements 1313 connected to each first support 1311 can be more than one, and the required number can be adjusted according to the support needs. The shape of the reinforcement 1313 can be set to any shape, such as bending or folding, provided that it has sufficient deformation allowance during expansion. When one reinforcement 1313 is connected to each first support 1311, the two ends of the reinforcement 1313 are respectively connected to the two side rods of the wave crest n1 formed after the first support 1311 is bent, and the position of the reinforcement 1313 connected to the side rod is located at the midpoint of the side rod's length direction, or at any position between the midpoint and the apex of the wave crest n1. This configuration not only provides reliable support for the first support 1311, but also makes the reinforcing member 1313 closer to the apex of the crest n1, resulting in a larger spatial area of ​​the hole formed between the reinforcing member 1313 and the middle body 11. Since this area is closer to the branch vessels of the pulmonary artery, reducing the obstruction caused by the reinforcing member 1313 makes it more conducive to blood flow.

[0055] like Figure 3 and Figure 4 As shown in this embodiment, a reinforcing member 1313 is connected to each of the first supports 1311 on the distal body 13. For example, if there are three first supports 1311, then there are also three reinforcing members 1313. Furthermore, the two ends of the reinforcing member 1313 are respectively connected to two side rods formed by bending the first supports 1311. Simultaneously, a bent portion 1314 is formed on the reinforcing member 1313, which is used to connect with an adjacent wave crest 1111 on the middle body 11. An adjacent wave crest 1111 refers to the wave crest 1111 in the grid structure 111 on the middle body 11 that has the shortest distance to the bent portion 1314. Connecting the bent portion 1314 to the adjacent crest 1111 not only further enhances the support for the first support body 1311, but also allows the reinforcing member 1313 and the grid structure 111 to pull against each other during expansion, generating mutual force, which is more conducive to the uniform expansion of the whole.

[0056] According to the pulmonary valve stent 1 provided by the above technical solution, the total outer surface area of ​​each first support 1311 accounts for ≤2.5% of the outer surface area of ​​the cylinder formed by the unit bodies 131; the total outer surface area of ​​each reinforcing member 1313 accounts for ≤2.0% of the outer surface area of ​​the cylinder formed by the unit bodies 131. Here, the outer surface area refers to the total surface area of ​​an object; for example, the outer surface area of ​​the first support 1311 refers to the total surface area of ​​the first support 1311. Furthermore, the total outer surface area of ​​each first support 1311 accounts for ≤2.3% of the outer surface area of ​​the cylinder formed by the unit bodies 131; the total outer surface area of ​​each reinforcing member 1313 accounts for ≤1.8% of the outer surface area of ​​the cylinder formed by the unit bodies 131; even further, the total outer surface area of ​​each first support 1311 accounts for ≤2.0% of the outer surface area of ​​the cylinder formed by the unit bodies 131; the total outer surface area of ​​each reinforcing member 1313 accounts for ≤1.5% of the outer surface area of ​​the cylinder formed by the unit bodies 131. The ratio of the total outer surface area of ​​each first support 1311 to the outer surface area of ​​the cylinder formed by the unit bodies 131 directly affects the axial and radial support force of the distal body 13. If the distal body 13 of the valve frame 1 cannot be well fixed in the surrounding tissue, it will affect the fixation effect of the valve frame 1. The ratio of the total outer surface area of ​​each reinforcing member 1313 to the outer surface area of ​​the cylinder formed by the unit bodies 131 will affect the uniformity of the expansion of each unit body 131 and even the petal frame 1, and ultimately affect the performance of the entire petal frame 1. Therefore, setting the structure of each first support 1311 and each reinforcing member 1313 within a reasonable range can improve the overall reliability of the petal frame 1.

[0057] like Figure 1 and Figure 3As shown, in the pulmonary valve stent 1 provided by the above technical solution, the included angle β1 formed by the bending of the first support 1311 is [40°, 110°] and / or the included angle β2 formed by the bending of the second support 1312 is [40°, 179°]. Specifically, the included angle β1 formed by the bending of the first support 1311 not only affects the strength of the support, but also affects the shape of the formed tip, thereby affecting the reliability of the tip's insertion into the tissue. Therefore, optionally, setting the included angle β1 formed by the bending of the first support 1311 to [40°, 110°] can better meet the usage requirements. Further, the included angle β1 formed by the bending of the first support 1311 is [50°, 100°], and even further, the included angle β1 formed by the bending of the first support 1311 is [60°, 90°]. The angle β2 formed by the bending of the second support 1312 affects the uniformity of the expansion of the valve frame 1 under the action of the balloon. If the angle is too large, it is not conducive to the expansion of the crest n1 and its axially connected support rod 1113, resulting in uneven expansion of the entire valve frame 1 and failing to provide effective support to the tissue. Therefore, optionally, the angle β2 formed by the bending of the second support 1312 is set to [40°, 179°]; further, the angle β2 formed by the bending of the second support 1312 is [50°, 170°]; and even further, the angle β2 formed by the bending of the second support 1312 is [60°, 160°].

[0058] like Figure 1 and Figure 2 As shown, in some possible embodiments, the grid structure 111 is a regular polygon, which can be any one of quadrilateral, hexagon, heptagon or octagon; or the grid structure 111 is an irregular polygon, which can be of any shape as long as it can expand uniformly during expansion and can reliably provide support.

[0059] Furthermore, such as Figure 1 As shown, the valve frame 1 provided in this embodiment has two ends, namely the proximal body 12 and the distal body 13, with a diameter slightly larger than that of the middle body 11, forming a waist-drum-shaped structure. The diameter gradually decreases from the end to the middle waist 112, thereby further improving the fixation effect of the valve frame 1 and preventing displacement.

[0060] like Figure 1As shown, according to the valve frame 1 provided by the above technical solution, the ratio of the maximum diameter of the proximal body 12 and / or the distal body 13 to the minimum diameter of the middle body 11 is (1, 1.8]:1. Further, the ratio of the maximum diameter of the proximal body 12 and / or the distal body 13 to the minimum diameter of the middle body 11 is [1.1, 1.5]:1; even further, the ratio of the maximum diameter of the proximal body 12 and / or the distal body 13 to the minimum diameter of the middle body 11 is [1.1, 1.4]:1.

[0061] Furthermore, the ratio of the maximum diameter of the proximal body 12 to the minimum diameter of the middle body 11 can be equal to or unequal to the ratio of the maximum diameter of the distal body 13 to the minimum diameter of the middle body 11. That is, the maximum diameter of the proximal body 12 of the valve frame 1 can be equal to or unequal to the maximum diameter of the distal body 13.

[0062] Furthermore, the ratio of the maximum diameter of the proximal body 12 to the minimum diameter of the middle 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 middle 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.

[0063] like Figure 1 As shown, according to the valve frame 1 provided by the above technical solution, the middle body 11 has a waist 112 with a uniform diameter, and a connecting portion 113 extending from the edge of the waist 112 toward the proximal body 12 and / or the distal body 13, with a gradually increasing diameter. The proximal body 12 and the distal body 13 are respectively connected to their corresponding connecting portions. Since the diameters of the proximal body 12 and the distal body 13 are designed to be different from the diameter of the middle body 11 according to the usage requirements, the smoothness of the overall structure of the valve frame 1 is ensured through the filtering connection of the connecting portion 113.

[0064] like Figure 1 As shown, according to the pulmonary valve frame 1 provided by the above technical solution, the length of the waist portion 112 of the valve frame 1 is 15%-60% of the total length of the valve frame 1; further, the length of the waist portion 112 of the valve frame 1 is 20%-40% of the total length of the valve frame 1. With the total length of the valve frame 1 remaining constant, different lengths of the waist portion 112 will result in changes in the lengths of the proximal body 12, the distal body 13, and the connecting portion 113. If the waist portion 112 is longer, the connecting portion 113 becomes shorter, resulting in a larger angle of inclination of the entire valve frame 1 from the waist portion 112 towards both ends; conversely, if the waist portion 112 is shorter, the connecting portion 113 becomes longer, resulting in a smaller angle of inclination of the entire valve frame 1 from the waist portion 112 towards both ends. Thus, the valve frame 1 can have different shapes and a wide range of applications. In this embodiment, by designing the length of the waist portion 112 within the above-mentioned numerical range, different design requirements can be met.

[0065] like Figure 1 As shown, according to the above technical solution, the angle between the line connecting the vertex of the distal body 13 and the midpoint of the waist 112 and the central axis of the petiole frame 1 is α1, and the angle between the line connecting the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the petiole frame 1 is α2. The size of α1 or α2 is between (0°, 30°), where α1 = α2, or α1 ≠ α2, or α1 is less than α2.

[0066] In some embodiments of this application, the magnitudes of α1 and α2 are both within the range of (0°, 30°); in other embodiments of this application, the included angle α1 formed by the distal body 13 is within the range of (0°, 30°), while the included angle α2 formed by the proximal body 12 is not within the range of (0°, 30°); in still other embodiments, the included angle α1 formed by the distal body 13 is not within the range of (0°, 30°), while the included angle α2 formed by the proximal body 12 is within the range of (0°, 30°).

[0067] Furthermore, in some embodiments of this application, the included angle α1 formed by the distal body 13 and the included angle α2 formed by the proximal body 12 are of the same size, that is, α1=α2; while in other embodiments of this application, α1 and α2 are of different sizes, that is, α1≠α2.

[0068] Furthermore, the included angle α1 formed by the distal body 13 is less than or equal to the included angle α2 formed by the proximal body 12.

[0069] In the embodiments of this application, α1 and α2 are set at different angles, which can make the distal body 13 and the proximal body 12 have different degrees of expansion, that is, the distal body 13 and the proximal body 12 can have different sizes, thereby meeting the usage requirements of blood vessels of different sizes.

[0070] According to the petal frame 1 provided by the above technical solution, along the direction from the distal body 13 to the proximal body 12, the crest 1111 of the (n+1)th grid structure 111 and the trough 1112 of the nth grid structure 111 are directly connected or connected by a connecting rod (not shown in the figure), where n≥1. That is, in the same direction, the connection between two adjacent grid structures 111 of the middle body 11 can be a direct connection or an indirect connection through a connecting rod. The specific connection method can be flexibly selected according to the actual design requirements, which provides good flexibility.

[0071] It should be noted that the connecting rod mentioned in this application can be a straight line or a non-straight line, such as an S-shaped, ω-shaped, or Ω-shaped rod.

[0072] like Figure 1 and Figure 3As shown in this embodiment, the proximal body 12 includes a third support 121 formed in a preset shape. The third support 121 is connected to the peaks 1111 of the adjacent partial or complete grid structure 111. Specifically, the third support 121 is usually set to be the same material and size as the first support 1311 for easy manufacturing. It only needs to be constructed (such as bent, woven, cut, or wound) into a preset shape according to design requirements, which can be a ring or a grid. Then, according to requirements, all or part of the peaks 1111 on the middle body 11 opposite to the third support 121 are selectively connected to the third support 121 to form different structures. Optionally, the third support 121 can be continuously bent into a closed ring with multiple corrugated structures, and then the troughs 1112 in the corrugated structure are connected to the peaks 1111 on the middle body 11.

[0073] like Figure 1 and Figure 3 As shown, in some possible embodiments, the proximal body 12 further includes a connecting rod 122, through which the third support 121 is connected to the crest 1111 of the mesh structure 111. Specifically, the connecting rod 122 is used to connect the third support 121 to the opposite crest 1111. The addition of the connecting rod 122 effectively increases the overall length of the proximal body 12, making it easier for the proximal body 12 to bulge, expand into a cylinder, or exhibit an outwardly flared trumpet shape, thus improving the reliability of its positioning with the implanted tissue.

[0074] Furthermore, the length of the connecting rod 122 is 0.8mm-4mm; or the length of the connecting rod 122 is 1.5mm-3.5mm. According to design requirements, the connecting rod 122 can be set to different lengths within this range, thereby enabling the proximal body 12 to be constructed into different specifications and shapes, resulting in a wide range of applications.

[0075] According to the above technical solution, the polygons formed on the valve frame 1, distal body 13, and proximal body 12 are irregular polygons. In some embodiments of this application, due to the design of the patterned structure of the valve frame 1, the polygons formed by the waveform structure of the proximal body 12 or distal body 13 under the same balloon force are naturally irregular polygons. In other embodiments of this application, the waveform structure of the proximal body 12 or distal body 13 is designed as a regular polygon, but the outward force applied by the balloon to different positions of the proximal body 12 or distal body 13 is different, resulting in irregular shapes of the polygons of the proximal body 12 or distal body 13. In some embodiments, the polygons formed by the waveform structures of the distal body 13 and proximal body 12 are non-planar polygons with certain folding curves and forming a structure with a certain three-dimensional shape.

[0076] The valve frame 1 provided in this embodiment has a radial support force of [6 kPa, 140 kPa] for the middle body 11, or [12 kPa, 100 kPa] for the middle body 11; a radial support force of [6 kPa, 120 kPa] for the proximal body 12; and a radial support force of [6 kPa, 100 kPa] for the distal body 13. The deformation resistance of the distal body 13 is greater than or equal to 1.5 N. Setting the valve frame 1 to have a radial support force within the above-mentioned numerical range ensures that the valve frame 1 is easily positioned on the valve annulus and that the valve leaflets are not easily washed away by blood flow. It also avoids excessive radial support force, which could hinder valve compression and delivery, or cause damage to the valve annulus and aorta due to insufficient deformation. The valve frame 1, with its support force within the above-mentioned numerical range, effectively meets the usage requirements and exhibits good reliability.

[0077] The valve frame 1 provided in this embodiment has a deformation resistance of the distal body 13 greater than or equal to 0.5N (deformation resistance refers to the force required for the distal body 13 to undergo irreversible deformation under continuous pressure). This deformation resistance within this range provides the distal body 13 with good axial support performance and compressive strength that meets usage requirements. This reduces damage caused by irreversible deformation of the distal body 13 under axial pressure, such as changes in the axial support position leading to poor or failed support, or the formation of protrusions or sharp points that could puncture tissue, thus significantly improving the safety and reliability of the valve frame 1.

[0078] According to the petiole cage 1 provided by the above technical solution, the yield strength of the petiole cage 1 substrate is 350-1450 MPa; and / or the tensile strength of the petiole cage 1 substrate is 400-1500 MPa. The petiole cage 1 substrate used in this application has good yield strength or tensile strength, thus ensuring that the petiole cage 1 has the smallest possible diameter and material usage under the condition of achieving the corresponding radial support force, which is beneficial to the delivery of the petiole cage 1 in vivo. When the petiole cage 1 substrate is a biodegradable petiole cage 1, the petiole cage 1 will reduce the burden of in vivo degradation / absorption due to the less material used.

[0079] According to the above technical solution, the elongation of the base material of the petiole frame 1 is greater than or equal to 5%. The base material of the petiole frame 1 used in this application has a good elongation, so the petiole frame 1 has good transport performance in vivo. In addition, the petiole frame 1 also has better plasticity and is not easy to break.

[0080] According to the petal frame 1 provided by the above technical solution, the substrate of the petal frame 1 is a biodegradable material, and / or the material of the substrate of the petal frame 1 includes at least one of pure iron, iron alloy, pure magnesium, magnesium alloy, pure zinc or zinc alloy.

[0081] The valve frame 1 provided in this invention can be directly sutured to the leaflet to form a complete valve for implantation in the body, or it can be used as an independent valve frame 1 with another leaflet placed inside.

[0082] It should be specifically noted that in this application, "a certain alloy" refers to an alloy containing the element. For example, a ferroalloy means an alloy containing iron, a zinc alloy means an alloy containing a new element, and a magnesium alloy means an alloy containing magnesium. Furthermore, "a certain alloy" can refer to an alloy in which the mass or volume content of a certain element is greater than or equal to 0.25%, and the remaining 99.75% and components can be composed of any other metallic and / or non-metallic elements. For instance, a ferroalloy refers to an alloy in which the mass / volume content of iron is greater than or equal to 0.25%, and so on. Furthermore, the ferroalloys described in this invention 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; the 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; the magnesium alloys include, but are not limited to, magnesium-manganese alloys, magnesium-zinc alloys, magnesium-aluminum alloys, and magnesium-iron alloys.

[0083] In this application, "pure metal" refers to a metal in which the total content of other impurities is less than or equal to 0.5 wt.%. For example, pure iron refers to a metal in which the total amount of other metals and / or non-metals besides iron is less than or equal to 0.5 wt.%.

[0084] This application embodiment also provides a pulmonary valve, including leaflets and the aforementioned valve frame 1, with the leaflets connected to the valve frame 1. By using the aforementioned valve frame 1, which not only expands uniformly but also provides suitable radial support, the pulmonary valve ensures that the valve frame 1 is easily positioned on the valve annulus and that the leaflets are not easily washed away by blood flow, greatly improving the reliability of the pulmonary valve.

[0085] All data in this application refer to the corresponding values ​​of the middle portion of the valve frame 1 at the nominal diameter. The "nominal diameter" refers to the diameter of the middle portion of the valve frame 1 when it is fully dilated under nominal pressure, and the nominal diameter refers to the diameter of the valve frame 1 when it is fully dilated under nominal pressure. The nominal pressure refers to the pressure required to fully dilate the valve frame 1 clinically. Full dilation refers to the state when the valve frame 1 is dilated to match the diameter of its application lumen.

[0086] The range of values ​​for X1-X2 mentioned in this application means that the value can be either X1 or X2, or any value within the range of X1 and X2; that is, the range is a closed interval. For example, if this application mentions "the wall thickness of the support is 0.04mm-0.5mm", then the wall thickness of the support can be 0.04mm, 0.5mm, or any value between 0.04mm and 0.5mm.

[0087] To facilitate understanding of the present invention, the design points of the invention are illustrated below with reference to some specific embodiments. It should be understood that the related embodiments are merely illustrative examples of the present invention and do not constitute a limitation on the scope of application.

[0088] Example 1

[0089] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, made of nitrided iron with a tensile strength of 850 MPa and a yield strength of 750 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 18 support rods. The support rods have a wall thickness of 0.23 mm and a width of 0.25 mm. The distal body 13 includes a first support body 1311 and a second support body 1312, forming three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131. The area of ​​a single opening 132 is 16% of the area of ​​the distal body 13 and the area formed by the combination of all openings 132. A reinforcing member 1313 is provided. The height of the crest n2 is half the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.3% and 1.2% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 75°, and the included angle β2 of the second support body is 90°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 3.5 mm. The length of the waist 112 accounts for 20% of the total length of the petal frame 1. The two ends of the petal frame 1 are raised. The diameter of the middle body 11 is 20 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body is 1.2. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 8°.

[0090] The radial support force of the middle body 11 is 30 kPa, the radial support force of the proximal body 12 is 25 kPa, the radial support force of the distal body 13 is 15 kPa, and the axial deformation is 3.5 N. The valve frame 1 can be implanted into the pulmonary valve of a dog through interventional methods. The valve frame 1 expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0091] Example 2

[0092] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 12 support rods. The support rod wall thickness is 0.15 mm and the rod width is 0.35 mm. The distal body 13 includes a first support body 1311 and a second support body 1312. The rod width of the first support body 1311 is locally increased by 1.5 times. The first support body 1311 and the second support body 1312 form two "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131. The area of ​​a single opening 132 is 25% of the area of ​​the distal body 13 and the area formed by the combination of each opening 132. A reinforcing member 1313 is provided. The height of the crest n2 is 2 / 3 of the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.2% and 0.6% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 110°, and the included angle β2 of the second support body is 160°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 1.5 mm. The length of the waist 112 accounts for 60% of the total length of the petal frame 1. The two ends of the petal frame 1 are raised. The diameter of the middle body 11 is 16 mm. The maximum diameter ratios of the proximal body 12 and the distal body 13 to the middle body 11 are 1.8 and 1.4, respectively. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are 30° and 14°, respectively.

[0093] The radial support force of the middle body 11 is 6 kPa, the radial support force of the proximal body 12 is 6 kPa, the radial support force of the distal body 13 is 6 kPa, and the axial deformation is 1.8 N. The valve holder 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0094] Example 3

[0095] This embodiment provides a valve frame 1 for pulmonary artery valves, made of cobalt-chromium alloy with a tensile strength of 1500 MPa and a yield strength of 1450 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 18 support rods. The support rods are 0.4 mm thick and 0.5 mm wide. The distal body 13 includes a first support body 1311 and a second support body 1312, forming three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area of ​​a single opening 132 is 10% of the area formed by the distal body 13 and the combined area of ​​the openings 132. A reinforcing member 1313 is provided. The height of the crest n2 is half the height of the crest n1. The total outer surface area of ​​each first support body 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 2.5% and 2.0% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 50°, and the included angle β2 of the second support body is 90°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 0.8 mm. The length of the waist 112 accounts for 15% of the total length of the petal frame 1. The two ends of the petal frame 1 are raised. The diameter of the middle body 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.2. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 7°.

[0096] The radial support force of the middle body 11 is 140 kPa, the radial support force of the proximal body 12 is 120 kPa, the radial support force of the distal body 13 is 100 kPa, and the axial deformation is 6.2 N. The valve holder 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0097] Example 4

[0098] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, made of an iron-manganese alloy with a tensile strength of 1500 MPa and a yield strength of 1450 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 18 support rods. The support rods are 0.4 mm thick and 0.4 mm wide. The distal body 13 includes a first support body 1311 and a second support body 1312, forming three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131. The area of ​​a single opening 132 is 11% of the area of ​​the distal body 13 and the area formed by the combination of all openings 132. A reinforcing member 1313 is provided. The height of the crest n2 is half the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 2.0% and 1.5% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 75°, and the included angle β2 of the second support body is 90°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 0.8 mm. The length of the waist 112 accounts for 15% of the total length of the petiole frame. The two ends of the petiole frame 1 are raised. The diameter of the middle body 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.2. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 to the midpoint of the waist 112 and the central axis of the middle body 11 are both 7°.

[0099] The radial support force of the middle body 11 is 120 kPa, the radial support force of the proximal body 12 is 100 kPa, the radial support force of the distal body 13 is 75 kPa, and the axial deformation is 5.8 N. The valve holder 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0100] Example 5

[0101] This embodiment provides a valve frame 1 for pulmonary artery valves, made of cobalt-chromium alloy with a tensile strength of 1500 MPa and a yield strength of 1450 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 18 support rods to form a closed loop. The support rods are 0.3 mm thick and 0.4 mm wide. The distal body 13 includes a first support body 1311 and a second support body 1312, forming three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area of ​​a single opening 132 is 11% of the area of ​​the distal body 13 and the area formed by the combination of all openings 132. A reinforcing member 1313 is provided. The height of the crest n2 is half the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 2.0% and 1.5% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 90°, the included angle β2 of the second support body is 90°, the distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 0.8 mm. The length of the waist 112 accounts for 15% of the total length of the petiole frame. The two ends of the petiole frame 1 are raised. The diameter of the middle body 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.2. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 to the midpoint of the waist 112 and the central axis of the middle body 11 are both 7°.

[0102] The radial support force of the middle body 11 is 100 kPa, the radial support force of the proximal body 12 is 85 kPa, the radial support force of the distal body 13 is 70 kPa, and the axial deformation is 5.2 N. The valve holder 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0103] Example 6

[0104] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 24 support rods. The support rods have a wall thickness of 0.35 mm and a width of 0.15 mm. The distal body 13 includes a first support body 1311 and a second support body 1312, forming four "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area of ​​a single opening 132 is 15% of the area of ​​the distal body 13 and the area formed by the combination of all openings 132. A reinforcing member 1313 is provided. The height of the crest n2 is half the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.5% and 1.3% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 40°, and the included angle β2 of the second support body is 110°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 3.5 mm. The length of the waist 112 accounts for 20% of the total length of the valve frame. The two ends of the frame are raised. The diameter of the middle body 11 is 24 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.3. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 9°.

[0105] The radial support force of the middle body 11 is 60 kPa, the radial support force of the proximal body 12 is 45 kPa, the radial support force of the distal body 13 is 25 kPa, and the axial deformation is 4.8 N. The valve stent can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0106] Example 7

[0107] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 18 support rods to form a closed loop. The support rods have a wall thickness of 0.29 mm and a width of 0.4 mm. The distal body 13 includes a first support body 1311 and a second support body 1312, forming three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area of ​​a single opening 132 is 17% of the area of ​​the distal body 13 and the area formed by the combination of all openings 132. A reinforcing member 1313 is provided. The height of the crest n2 is half the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.8% and 1.6% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 40°, the included angle β2 of the second support body is 40°, the distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 1.5mm. The length of the waist 112 accounts for 40% of the total length of the petiole frame. The two ends of the petiole frame 1 are raised. The diameter of the middle body 11 is 28 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.5. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 25°.

[0108] The radial support force of the middle body 11 is 40 kPa, the radial support force of the proximal body 12 is 30 kPa, the radial support force of the distal body 13 is 15 kPa, and the axial deformation is 5.1 N. The valve holder 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0109] Example 8

[0110] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, made of nitrided iron with a tensile strength of 900 MPa and a yield strength of 850 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 18 support rods to form a closed loop. The support rods have a wall thickness of 0.4 mm and a width of 0.5 mm. The distal body 13 includes a first support body 1311 and a second support body 1312, forming three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area of ​​a single opening 132 is 18% of the area of ​​the distal body 13 and the area formed by the combination of all openings 132. A reinforcing member 1313 is provided. The height of the crest n2 is half the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.6% and 1.2% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 60°, the included angle β2 of the second support body is 60°, the distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 2.5mm. The length of the waist 112 accounts for 25% of the total length of the petiole frame. The two ends of the petiole frame 1 are raised. The diameter of the middle body 11 is 30 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.2. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 11°.

[0111] The radial support force of the middle body 11 is 45 kPa, the radial support force of the proximal body is 35 kPa, the radial support force of the distal body is 20 kPa, and the axial deformation is 6.1 N. The stent can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0112] Example 9

[0113] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, made of nitrided iron with a tensile strength of 850 MPa and a yield strength of 800 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 18 support rods to form a closed loop. The support rods are 0.18 mm thick and 0.3 mm wide. The distal body 13 includes a first support body 1311 and a second support body 1312, forming three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area of ​​a single opening 132 is 15% of the area of ​​the distal body 13 and the area formed by the combination of all openings 132. A reinforcing member 1313 is provided. The height of the crest n2 is half the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.4% and 1.3% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 60°, and the included angle β2 of the second support body is 170°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 2.8 mm. The length of the waist 112 accounts for 15% of the total length of the petiole frame. The two ends of the petiole frame 1 are raised. The diameter of the middle body 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.1. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 3°.

[0114] The radial support force of the middle body 11 is 12 kPa, the radial support force of the proximal body 12 is 8 kPa, the radial support force of the distal body 13 is 6 kPa, and the axial deformation is 1.6 N. The valve frame 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0115] Example 10

[0116] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, made of nitrided iron with a tensile strength of 850 MPa and a yield strength of 800 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is formed by 18 support rods to form a closed loop. The support rods have a wall thickness of 0.28 mm and a width of 0.18 mm. The distal body 13 includes a first support body 1311 and a second support body 1312, forming three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area of ​​a single opening 132 is 13% of the area of ​​the distal body 13 and the area formed by the combination of all openings 132. A reinforcing member 1313 is provided. The height of the crest n2 is 1 / 3 of the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.0% and 0.9% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 60°, and the included angle β2 of the second support body is 179°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 2.8 mm. The length of the waist 112 accounts for 15% of the total length of the petiole frame. The two ends of the petiole frame 1 are raised. The diameter of the middle body 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.3. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 10°.

[0117] The radial support force of the middle body 11 is 50 kPa, the radial support force of the proximal body 12 is 40 kPa, the radial support force of the distal body 13 is 30 kPa, and the axial deformation is 2.6 N. The valve holder 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands evenly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0118] Example 11

[0119] This embodiment provides a valve frame 1 for a magnesium-based absorbable pulmonary valve, made of magnesium alloy with a tensile strength of 400 MPa and a yield strength of 350 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is composed of 18 support rods forming a closed loop. The support rods have a wall thickness of 0.3 mm and a rod width of 0.3 mm. The distal body 13 includes a first support body 1311 and a second support body 1312. Notably, the wall thickness and rod width of the first support body 1311 are locally increased by 1.3 times. The first support body 1311 and the second support body 1312 constitute three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131. The area of ​​a single opening 132 is 14% of the area of ​​the distal body 13 and the area formed by the combination of each opening 132. A reinforcing member 1313 is provided. The height of the crest n2 is 1 / 3 of the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.6% and 1.3% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 40°, and the included angle β2 of the second support body is 50°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 1.5 mm. The length of the waist 112 accounts for 15% of the total length of the petiole frame. The two ends of the petiole frame 1 are raised. The diameter of the middle body 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.3. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 10°.

[0120] The radial support force of the middle body 11 is 12 kPa, the radial support force of the proximal body 12 is 8 kPa, the radial support force of the distal body 13 is 8 kPa, and the axial deformation is 2.1 N. The valve holder 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0121] Example 12

[0122] This embodiment provides a valve frame 1 for a magnesium-based absorbable pulmonary valve, made of magnesium alloy with a tensile strength of 500 MPa and a yield strength of 400 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is composed of 18 support rods to form a closed loop. The support rod wall thickness is 0.3 mm and the rod width is 0.28 mm. The distal body 13 includes a first support body 1311 and a second support body 1312. Notably, the wall thickness and rod width of the first support body 1311 are locally increased by 1.5 times. The first support body 1311 and the second support body 1312 constitute three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131. The area of ​​a single opening 132 is 13% of the area of ​​the distal body 13 and the area formed by the combination of each opening 132. A reinforcing member 1313 is provided. The height of the crest n2 is 1 / 3 of the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.9% and 1.3% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 75°, and the included angle β2 of the second support body is 90°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 2.8 mm. The length of the waist 112 accounts for 15% of the total length of the petiole frame. The two ends of the petiole frame 1 are raised. The diameter of the middle body 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.3. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 10°.

[0123] The radial support force of the middle body 11 is 12 kPa, the radial support force of the proximal body 12 is 8 kPa, the radial support force of the distal body 13 is 10 kPa, and the axial deformation is 2.6 N. The valve holder 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands uniformly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0124] Example 13

[0125] This embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, made of nitrided iron with a tensile strength of 950 MPa and a yield strength of 900 MPa. The valve frame 1 includes a central body 11, a proximal body 12, and a distal body 13. The central body 11 is composed of multiple interconnected grid structures, and each grid structure in the same circumferential direction is composed of 18 support rods to form a closed loop. The support rod wall thickness is 0.3 mm and the rod width is 0.3 mm. The distal body 13 includes a first support body 1311 and a second support body 1312. The first support body 1311 and the second support body 1312 constitute three "M"-shaped unit bodies 131. A "W"-shaped opening 132 is formed between two adjacent unit bodies 131. The area of ​​a single opening 132 is 14% of the area of ​​the distal body 13 and the area formed by the combination of each opening 132. A reinforcing member 1313 is provided. The height of the crest n2 is half the height of the crest n1. The total outer surface area of ​​each first support 1311 and the total outer surface area of ​​each reinforcing member 1313 account for 1.1% and 0.9% of the outer surface area of ​​the cylinder formed by the unit bodies 131, respectively. The included angle β1 of the first support body is 70°, and the included angle β2 of the second support body is 100°. The distal body 13 is directly connected to the middle body 11, and the proximal body 12 is connected to the middle body 11 through a connecting rod with a length of 4mm. The length of the waist 112 accounts for 15% of the total length of the petiole frame. The two ends of the petiole frame 1 are raised. The diameter of the middle body 11 is 16 mm. The maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.3. The angles α1 and α2 between the line connecting the vertex of the distal body 13 and the vertex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 are both 8°.

[0126] The radial support force of the middle body 11 is 55 kPa, the radial support force of the proximal body 12 is 40 kPa, the radial support force of the distal body 13 is 30 kPa, and the axial deformation is 3 N. The valve holder 1 can be implanted into the pulmonary valve of a dog through interventional methods. The stent expands evenly, can be well fixed in the lumen, does not shift, can support the lumen, and does not affect the blood flow of the distal branches.

[0127] Comparative Example 1

[0128] The pulmonary valve stent design in this embodiment is basically the same as that in Embodiment 1. The difference is that the distal body in this embodiment does not have an "M" shaped contour unit and does not form a "W" shaped opening.

[0129] The stent can be implanted into the pulmonary valve of a dog via interventional methods. The stent is well fixed in the lumen without displacement and can support the lumen. However, the stent distal to the lumen affects the blood flow of the distal branch, resulting in reduced blood flow to the branch.

[0130] Comparative Example 2

[0131] The pulmonary valve stent design in this embodiment is basically the same as that in Embodiment 1. The difference is that the two ends of the stent are not raised in this embodiment, and the diameters of the distal body, proximal body and middle body of the stent are the same.

[0132] The stent can be implanted into the pulmonary valve of a dog via interventional methods, but the stent is difficult to fix in the lumen and is prone to displacement.

[0133] Comparative Example 3

[0134] The pulmonary valve stent design in this embodiment is basically the same as that in Embodiment 2, except that no reinforcing element is provided in this embodiment.

[0135] The stent has a radial support force of 6 kPa in the middle, 6 kPa in the proximal, and 6 kPa in the distal portion, with an axial deformation of only 0.5 N. The stent can be implanted into the pulmonary valve of a dog via interventional methods. The stent is well fixed in the lumen without displacement, supports the lumen, and does not affect the blood flow of the distal branches. However, the distal portion deforms axially and twists, puncturing the blood vessel.

[0136] Comparative Example 4

[0137] The pulmonary valve stent design in this embodiment is basically the same as that in Embodiment 2, except that the included angle β1 of the first support body is 30° and the included angle β2 of the second support body is 30°.

[0138] The stent's radial support force in the middle section is only 4 kPa, in the proximal section only 3 kPa, and in the distal section only 2 kPa, with an axial deformation of 1.6 N. The stent can be implanted into the pulmonary valve of a dog via interventional methods. The stent is well fixed in the lumen without displacement. However, the stent's support force is low and it cannot support the blood vessel. After the balloon is depressurized, the stent is crushed by the blood vessel.

[0139] Comparative Example 5

[0140] The pulmonary valve stent design in this embodiment is basically the same as that in Embodiment 1, except that the stent in this embodiment is not a fully closed design.

[0141] The stent has a mid-body radial support force of 28 kPa, a proximal-body radial support force of 20 kPa, and a distal-body radial support force of 12 kPa, with an axial deformation of 2.6 N. The stent can be implanted into the pulmonary valve of a dog via interventional methods. The stent is well fixed in the lumen without displacement. However, uneven stent expansion leads to uneven valve distribution, and the valve cannot close completely, resulting in regurgitation.

[0142] The above description is merely a preferred embodiment of this application, but the scope of protection of this application is not limited thereto. Rather, any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application.

Claims

1. A pulmonary valve stent, comprising a tubular central body, and proximal and distal bodies respectively connected to the axial ends of the central body, wherein the central body comprises a plurality of mesh structures, characterized in that, The distal body comprises multiple unit bodies with an "M"-shaped outline, wherein the number of the unit bodies is m, and m is a natural number greater than or equal to 2; The unit body includes a first support body and a second support body that are connected to each other at one end, and the end of the first support body and the second support body that are connected is connected to the middle body. The first support body is bent to form a peak n1, and the second support body is bent in the same direction to form a peak n2. The height of the peak n2 of the second support body is less than or equal to 2 / 3 of the height of the peak n1 of the two adjacent first support bodies. The width of the first support is 1.3 to 3.5 times the width of the second support.

2. The petiole frame according to claim 1, characterized in that, The two adjacent unit bodies form a "W"-shaped opening, and the area of ​​a single opening is ≥10% of the area of ​​the region formed by the distal body and the combination of the openings.

3. The valve frame according to claim 1, characterized in that, The grid structure consists of peaks, troughs, and support rods connecting the peaks and troughs. One end of the first support and the second support is connected to the adjacent peak.

4. The valve frame according to claim 3, characterized in that, The unit body also includes a reinforcing member disposed between the middle body and the distal body, and the reinforcing member is at least connected to the first support body.

5. The petiole frame according to claim 4, characterized in that, The total outer surface area of ​​each of the first supports accounts for ≤2.5% of the cylindrical side surface area enclosed by the combination of the unit bodies, and the total outer surface area of ​​each of the reinforcing members accounts for ≤2.0% of the cylindrical side surface area enclosed by the combination of the unit bodies.

6. The petiole frame according to claim 4, characterized in that, The reinforcing member has a bent portion formed thereon, and the bent portion is connected to the adjacent wave crest on the central body.

7. The valve frame according to claim 3, characterized in that, The included angle formed by the bending of the first support body is [40°, 110°] and / or the included angle formed by the bending of the second support body is [40°, 179°].

8. The valve frame according to claim 1, characterized in that, The ratio of the maximum diameter of the proximal body and / or the distal body to the minimum diameter of the middle body is (1-1.8):

1.

9. The petiole frame according to claim 1, characterized in that, The middle body has a waist with a uniform diameter, and a connecting portion extending from the edge of the waist toward the proximal body and / or the distal body, with the diameter gradually increasing. The proximal body and the distal body are respectively connected to the corresponding connecting portion.

10. The valve frame according to claim 9, characterized in that, The length of the waist is 15%-60% of the total length of the petiole; or the length of the waist is 20%-40% of the total length of the petiole.

11. The valve frame according to claim 9, characterized in that, The angle between the line connecting the vertex of the distal body and the midpoint of the waist and the central axis of the middle body is α1, and the angle between the line connecting the vertex of the proximal body and the midpoint of the waist and the central axis of the middle body is α2. The size of α1 or α2 is between (0°, 30°), where α1 = α2, or α1 ≠ α2, or α1 is less than α2.

12. The valve frame according to claim 3, characterized in that, The proximal body includes a third support body configured in a preset shape, the third support body being connected to the peaks of a portion or all of the adjacent mesh structure.

13. The valve frame according to claim 12, characterized in that, The proximal body also includes a connecting rod, and the third support is connected to the crest of the grid structure through the connecting rod.

14. The valve frame according to claim 13, characterized in that, The length of the connecting rod is 0.8mm-4mm.

15. The petiole frame according to any one of claims 1 to 14, characterized in that, The radial support force of the middle body is [6kPa, 140kPa], the radial support force of the proximal body is [6kPa, 120kPa], the radial support force of the distal body is [6kPa, 100kPa], and the deformation resistance of the distal body is greater than or equal to 1.5N.

16. The petiole frame according to any one of claims 1 to 14, characterized in that, The base material of the valve frame includes a biodegradable material, and / or the base material of the valve frame includes at least one of pure iron, iron alloy, pure magnesium, magnesium alloy, pure zinc, or zinc alloy.

17. A pulmonary artery valve, characterized in that, It includes leaflets and a valve frame as described in any one of claims 1 to 16, wherein the leaflets are connected to the valve frame.

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