Valve frame for pulmonary artery valve and pulmonary artery valve

Abstract

The invention belongs to the technical field of interventional medical instruments, and particularly relates to a valve frame for a pulmonary valve and the pulmonary valve. The valve frame comprises a tubular middle body, a near-end body and a far-end body, the near-end body and the far-end body are connected to the two axial ends of the middle body respectively, the middle body comprises a plurality of grid structures, the far-end body comprises a plurality of M-shaped unit bodies, the number of the unit bodies is m, and m is a natural number larger than or equal to 2. The pulmonary artery valve comprises a valve leaflet and the valve frame, and the valve leaflet is connected to the valve frame. The valve frame can be evenly expanded, and the overall shape consistency is good. By adopting the valve frame, the pulmonary artery valve can be uniformly expanded, the use requirement on uniform expansion of the pulmonary artery valve is well met, and the use reliability is good.

Description

Technical Field

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

[0002] After the first corrective surgery, patients with complex congenital heart disease (such as tetralogy of Fallot and pulmonary atresia) often have residual pulmonary regurgitation (PR), which is the most common long-term complication after such surgery (especially when transannular patch repair technology is used). Severe PR can cause aneurysmal dilatation and dysfunction of the right ventricular outflow tract (RVOT), aneurysmal dilatation of the pulmonary artery, ventricular dyssynchrony and arrhythmia, progressive right ventricular dilatation / right ventricular 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 valued. Traditional surgical pulmonary valve replacement requires another thoracotomy under extracorporeal circulation. Transcatheter pulmonary valve replacement (TPVR) is a minimally invasive surgical method that has gradually emerged since the first report by Bonhoeffer et al. in 2000. It can replace surgical pulmonary valve replacement and improve the long-term prognosis of such patients. Transcatheter pulmonary valve replacement (TPVR) uses a pulmonary valve stent for replacement. The pulmonary valve stent generally includes a stent to support the blood vessels and a valve to replace the original pulmonary valve. The valve is implanted into the pulmonary valve position through a percutaneous interventional procedure for valve replacement.

[0003] Transcatheter pulmonary valves can be released in two ways: balloon expansion and self-expanding expansion. Most of the valves on the market are self-expanding. The valve is placed in the carrier catheter and implanted percutaneously. The valve is released after reaching the corresponding position, and then the structure of the valve frame itself is used to fix the valve to the corresponding valve ring. However, the balloon-expandable stent cannot expand automatically after reaching the corresponding position. It must be expanded through the expansion of the balloon and the interaction between the support rods of the valve frame. Therefore, how to design a valve that can expand evenly under the action of the balloon and meet the requirements of pulmonary valve application is a big challenge. Summary of the invention

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

[0005] In a first aspect, the present application proposes a valve frame for a pulmonary valve, comprising a tubular middle body, and a proximal body and a distal body respectively connected to the axial ends of the middle body, wherein the middle body comprises a plurality of grid structures, and the distal body comprises a plurality of unit bodies with an "M"-shaped outline, wherein the number of the unit bodies is m, and m is a natural number greater than or equal to 2.

[0006] In some examples, the valve rack according to claim 1 is characterized in that the unit body includes a first support body and a second support body connected to each other at one end, and the end at which the first support body and the second support body are connected is connected to the middle body.

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

[0008] In some examples, the first support body is bent to form a wave peak n 1 The second support body is bent in the same direction to form a wave peak n 2 , the peak n of the second support 2 The height is less than or equal to the peak n of the first support body adjacent to both sides 1 2 / 3 of the height.

[0009] In some examples, the grid structure is composed of wave crests, wave troughs, and support rods connecting the wave crests and the wave troughs, and one end where the first support body and the second support body are connected is connected to the adjacent wave crest.

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

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

[0012] In some examples, the total surface area of ​​each of the first support bodies accounts for ≤2.5% of the cylindrical side surface area surrounded by the combination of the unit bodies, and the total surface area of ​​each of the reinforcements accounts for ≤2.0% of the cylindrical side surface area surrounded by the combination of the unit bodies.

[0013] In some examples, a bending portion is formed on the reinforcement, and the bending portion is connected to the adjacent wave crests on the middle body.

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

[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 and having a gradually increasing diameter, and the proximal body and the distal body are respectively 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 α 1 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 α 2 , α 1 or α 2 The size of is between (0°, 30°], where α 1 =α 2 , or α 1 ≠α 2 , or α 1 Less than α 2 .

[0019] In some examples, the proximal body includes a third support body formed in a preset shape, and the third support body is connected to adjacent parts or all of the wave crests of the grid structure.

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

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

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

[0023] In some examples, the material of the base material of the valve frame includes a degradable material, and / or the material of the base material of the valve frame includes at least any one of pure iron, iron alloy, pure magnesium, magnesium alloy, pure zinc or zinc alloy.

[0024] A second aspect of the present application provides a pulmonary valve, comprising a valve leaflet and the above-mentioned valve frame, wherein the valve leaflet is connected to the valve frame.

[0025] A valve frame for a pulmonary valve and a pulmonary valve provided in an embodiment of the present application, the valve frame includes a middle body, a proximal body and a distal body, and the proximal body and the distal body are respectively connected to the two ends of the middle body. A plurality of grid structures are arranged on the middle body, and the distal body is arranged into a plurality of unit bodies with an "M"-shaped outline, and each unit body is connected to the middle body. In this way, during the expansion process of the valve frame as a whole, since the "M"-shaped unit body can achieve the pulling of each connection point and the constraint of the expansion path, combined with the pulling and restraining effect of each grid structure during the expansion, the entire valve frame can be expanded uniformly, and the overall shape consistency is good. By adopting this valve frame, the pulmonary valve can expand uniformly, which well meets the use requirement that the pulmonary valve can expand uniformly, and has good reliability in use. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Various other advantages and benefits will become apparent to those of ordinary skill in the art by reading the detailed description of the preferred embodiments below. The accompanying drawings are only for the purpose of illustrating the preferred embodiments and are not to be considered as limiting the present application. In addition, the same reference numerals are used throughout the accompanying drawings to represent the same components. Among them:

[0027] Figure 1 A schematic diagram of the structure of the valve frame after expansion provided in an embodiment of the present application;

[0028] Figure 2 A schematic diagram of a plane structure of a valve frame in a compressed state provided in an embodiment of the present application;

[0029] Figure 3 An exploded schematic diagram of a valve frame after expansion provided in an embodiment of the present application;

[0030] Figure 4 A schematic diagram of the structure of a unit body provided in an embodiment of the present application;

[0031] Figure 5 A schematic diagram of a portion of the structure of the distal body provided in an embodiment of the present application. DETAILED DESCRIPTION

[0032] The exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present application are shown in the accompanying drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

[0033] It should be noted that the symbol “ / ” in the present application represents the meaning of “or”, such as “A / B” means “A or B”, and “A and / or B” means “A and B, or A or B”.

[0034] The term "about" or "substantially" used with respect to an amount includes variations in the recited amount that are equivalent to the recited amount, such as an amount that does not vary significantly from the recited amount for the intended purpose or function.

[0035] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0036] Test method:

[0037] Stent radial support force

[0038] The present invention uses a radial support force tester produced by Blockwise 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 stent is first compressed as a whole to the middle diameter, and then the middle body, proximal body and distal body are cut off separately, and the stent part to be tested is placed in a radial support force tester to simulate the actual stress state of the stent in the blood vessel, so that the stent is compressed and deformed under the action of the pressure head, and the pressure on the stent is measured when the diameter of the stent is reduced to 90% of the rated diameter D of the stent during the radial compression process.

[0040] like Figure 1 and Figure 2As shown, a valve frame 1 for a pulmonary valve provided in an embodiment of the present application comprises a middle body 11, a proximal body 12 and a distal body 13. The middle body 11 is constructed into a hollow tubular structure according to the use requirements, and can be a structure with a circular axial cross section. The hollow channel inside the middle body 11 is used for blood flow. Of course, it is understandable that the middle body 11 can also be constructed into other shapes such as a hexagon or an octagon according to the use requirements. The proximal body 12 and the distal body 13 are respectively connected to the axial ends of the middle body 11. Among them, the proximal body 12 and the distal body 13 are defined as follows: taking the distance between the entire valve frame 1 and the heart after being implanted in the living body as a reference, the end close to the heart is the proximal body 12, and the end away from the heart is the distal body 13. In order to realize the supporting function, the middle body 11 is configured to include a plurality of grid structures 111. After being expanded, each grid structure 111 can form a larger supporting surface, thereby realizing 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 the present application, the distal body 13 is configured to be a plurality of 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 Figure 1 ). With such arrangement, during the expansion process of the valve frame 1 as a whole, the "M"-shaped unit body 131 can achieve the pulling of each connection point and the self-constraint of shape deformation during expansion. At the same time, combined with the pulling and restraining effect of each grid structure 111 during expansion, the entire valve frame 1 can be expanded evenly, and the overall shape consistency is good, which well meets the use requirements of the valve frame 1. The outline of the unit body 131 is in the shape of "M", which is the shape presented when the distal body 13 of the valve frame 1 is placed vertically upward. If the distal body 13 of the valve frame 1 is placed vertically downward, the shape presented is "W". That is, with reference to different placement methods, the shape intuitively presented by the unit body 131 may be different. For ease of understanding, in the embodiment of the present application, the distal body 13 of the valve frame 1 is placed vertically upward, and the unit body 131 is described as being in the shape of "M".

[0042] Since there are some blood vessel 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 blood vessels. In the embodiment of the present application, the number of unit bodies 131 is set to m, and m is a natural number greater than or equal to 2. For example, other numbers such as 2, 3, 4, 5, etc., different numbers of unit bodies 131 can achieve different support areas. For example, the larger the value of m, the more units 131 there are, and the smaller the mesh of the valve frame 1; on the contrary, the smaller the value of m, the fewer units 131 there are, and the sparser the mesh of the valve frame 1. Therefore, the specific number of unit bodies 131 can be set according to different application situations.

[0043] It should be noted that the distal body of the embodiment of the present application can be composed of m "M" unit bodies, or can be composed of m "M" unit bodies and other shapes, and the other shapes include but are not limited to "V" shape.

[0044] Specifically, the valve frame 1 in the present application is a balloon-expandable valve frame, in which a balloon is placed inside the stent. The balloon is gradually expanded by inflating or adding liquid to the balloon, and the valve frame 1 expands outward with the help of the force generated by the expansion of the balloon. During the expansion process, the connection points can pull each other and constrain their own shape deformation during expansion, so that each part can be evenly stressed and deformed synchronously, thereby achieving the effect of uniform expansion and avoiding the problem of uneven expansion in a certain part that cannot effectively support the blood vessel. The expanded valve frame 1 has a uniform shape and good consistency, which improves the reliability of the use of the valve frame 1.

[0045] In the embodiment of the present application, a valve frame 1 is provided, wherein the distal body 13 is configured as a plurality of unit bodies 131 with an "M"-shaped outline, a plurality of grid structures 111 are provided on the middle body 11, and each unit body 131 is connected to the middle body 11. In this way, during the expansion process of the valve frame 1 as a whole, the "M"-shaped unit body 131 can realize the pulling of each connection point and the constraint of the expansion path, and at the same time, combined with the pulling and constraint effect of each grid structure 111 during the expansion, the purpose of synchronous expansion is achieved, so that the entire valve frame 1 can be expanded evenly, and the overall shape consistency is good.

[0046] like Figure 2 and Figure 4As shown, in some embodiments, the unit body 131 includes a first support body 1311 and a second support body 1312 connected to each other at one end, and the end where the first support body 1311 and the second support body 1312 are connected is connected to the middle body 11. Specifically, the unit body 131 is constructed by connecting the first support body 1311 and the second support body 1312 to each other in a preset shape, and the outer contour is "M" shaped, with two sawtooth-like tips, and the heights of the two tips can be the same or unequal. The first support body 1311 and the second support body 1312 can be the same rod-shaped component, the bent "M" shaped unit body 131; or they can be formed by splicing different rod-shaped components to each other. The inside of the two tips formed is a through hole for blood to pass through. Of course, it is understandable that, under the premise of ensuring that the outer contour of the unit body 131 is "M"-shaped and the coverage rate of the formed petal frame 1 meets reasonable use requirements, the number of the first support body 1311 and / or the second support body 1312 and the shape formed by the combination are not limited here.

[0047] like Figure 3 and Figure 5 As shown, in the embodiment of the present application, a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is ≥10%. Specifically, the "W"-shaped opening 132 between two adjacent unit bodies 131 refers to the opening 132 area formed between the first support body 1311 in the first unit body 131 and the first support body 1311 in the adjacent unit body 131 when the distal body 13 of the valve frame 1 is placed vertically upward, and the area also has the second support body 1312 in the first unit body 131, so that the overall outline of the opening 132 area formed by the combination is roughly "W"-shaped. It is defined that the distal body 13 and multiple openings 132 are combined to form a region, and the area ratio of each opening 132 to the area of ​​the region is ≥10%. In this way, not only can the overall support strength of the valve frame 1 be achieved within a suitable range, but also the overall material consumption of the distal body 13 is small and has a suitable coverage rate.

[0048] like Figure 3 to Figure 4 As shown, in some embodiments, the first support body 1311 is bent to form a wave crest n 1 The second support body 1312 is bent in the same direction to form a wave crest n 2 , the peak n of the second support body 1312 2 The height is less than or equal to the peak n of the first support bodies 1311 adjacent to each other on both sides. 1 Furthermore, the peak n of the second support body 1312 is 2 The height is less than or equal to the peak n of the first support body 1311 adjacent to both sides. 11 / 2 of the height of the wave crest n 2 The lower the height, the larger the "W"-shaped opening 132 is, and the more conducive it is to avoid blocking the branch vessels of the distal pulmonary artery, thereby effectively preventing the blockage of the branch vessels. Of course, under the premise of meeting the use requirements, the peak n 1 and peak n 2 The height relationship between them can also be other range values.

[0049] The structural design of the distal body 13 in the above-mentioned valve frame 1 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 supporting force in the axial direction, so that it can be stably fixed in the tissue in contact with the distal body 13, preventing the valve frame 1 from shifting, thereby improving the fixation effect of the valve frame 1.

[0050] like Figure 4 and Figure 5 As shown, according to the pulmonary valve stent 1 provided by the above technical solution, the wave peak n in the middle of the "W"-shaped opening 132 2 The area is less than or equal to the area of ​​the adjacent peaks n on both sides 1 1 / 3 of the area; further, the peak n in the middle of the "W"-shaped opening 132 2 The area is less than or equal to the area of ​​the adjacent peaks n on both sides 1 1 / 4 of the area. 1 The coverage area cannot be too small, otherwise it will not be easy to be evenly expanded by the balloon, and the peak n 1 The coverage area is too large, which may easily make the height of the "W"-shaped opening 132 too small, and may easily block the opening 132 of the branch blood vessel.

[0051] like Figure 2 and Figure 3 As shown, in the embodiment of the present application, the grid structure 111 is set to be composed of a crest 1111, a trough 1112 and a support rod 1113 connecting the crest 1111 and the trough 1112, that is, the grid structure 111 is a regular-shaped wave structure. Each grid structure 111 is evenly distributed in the circumferential direction of the middle body 11, connected end to end and closed in the circumferential direction, so as to have a support performance that meets the use requirements. The regular-shaped grid structure 111 can achieve uniform force on each grid structure 111 during expansion, thereby achieving uniform expansion. At the same time, one end connecting the first support body 1311 and the second support body 1312 is connected to the adjacent crest 1111. In this way, the first support body 1311 and the second support body 1312 can generate a pulling force in the axial direction during expansion, thereby achieving mutual pulling between the grid structure 111, the first support body 1311 and the second support body 1312 connected to each other, guiding the expansion deformation, and further improving the uniformity of the expansion.

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

[0053] like Figure 4 and Figure 5 As 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, and the reinforcing member 1313 is connected to at least the first supporting body 1311. In actual design, in order to increase the area of ​​the hole in the distal body 13 for blood to flow through, the wave crest n formed by bending the first supporting body 1311 is usually 1 The height of the first support body 1311 is large, so that a large hole can be formed for blood to flow through without causing obstruction. At the same time, in order to reduce the coverage rate 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. At the same time, considering the reliability of the overall support performance of the distal body 13, a reinforcement member 1313 is provided. By providing the reinforcement member 1313, the peak n is 1The reinforcement 1313 is usually a rod-shaped structure, and its material, shape, and size can be the same as those of the first support 1311, or it can be adjusted to be unnecessary according to the use requirements. The reinforcement 1313 is at least connected to the first support 1311, and the connection position can be any position on the first support 1311 that needs to be strengthened. The connection method can be: for example, the reinforcement 1313 is connected in parallel to the position on the first support 1311 that needs to be strengthened, so as to play a role of local reinforcement; or the two ends of the reinforcement 1313 are respectively connected to the two side rods formed by bending the first support 1311, so as to play a role of supporting the wave peak n 1 The axial support strength and radial support force are enhanced, or one end of the reinforcing member 1313 is connected to the wave crest n formed after the first support body 1311 is bent. 1 The other end is connected to any side rod, and the peak n can be 1 Thus, the supporting force provided by the reinforcing member 1313 can enhance the supporting performance of the distal body 13 and improve the reliability of use. 1 The reinforcement pieces 1313 are arranged at the two sides and / or apex, which can not only enhance the axial or radial supporting force of the first support body 1311, which is beneficial to fix the valve and prevent displacement, but also facilitate the full expansion of the two side rods formed after the first support body 1311 is bent.

[0054] like Figure 4 and Figure 5 As shown, according to the reinforcement member 1313 provided by the above technical solution, under the premise that the flap frame 1 meets the use requirements such as coverage rate and overall weight, the number of reinforcement members 1313 connected to each first support body 1311 can be more than one, and the number required to be set can be adjusted according to the support requirements. The shape of the reinforcement member 1313 can be set to any shape, such as bending or folding, if it has sufficient deformation margin during expansion. When a reinforcement member 1313 is connected to each first support body 1311, the two ends of the reinforcement member 1313 are respectively connected to the wave peak n formed after the first support body 1311 is bent. 1 The reinforcement member 1313 is connected to the side rod at the midpoint of the length direction of the side rod, or at the midpoint and the wave crest n. 1 Such an arrangement not only provides a reliable support force for the first support body 1311, but also makes the reinforcement member 1313 closer to the wave crest n. 1 The apex of the reinforcing member 1313 makes the spatial area of ​​the hole formed between the reinforcing member 1313 and the middle body 11 larger, and this place is closer to the branch blood vessels of the pulmonary artery, reducing the obstruction caused by the reinforcing member 1313, which is more conducive to blood flow.

[0055] like Figure 3 and Figure 4 As shown, in the embodiment of the present application, all the first support bodies 1311 on the distal body 13 are connected to a reinforcing member 1313. If three first support bodies 1311 are provided, three reinforcing members 1313 are also provided accordingly. In addition, the two ends of the reinforcing member 1313 are respectively connected to the two side rods formed after the first support body 1311 is bent. At the same time, a bending portion 1314 is formed on the reinforcing member 1313, and the bending portion 1314 is used to connect with the adjacent crest 1111 on the middle body 11. The adjacent crest 1111 refers to the crest 1111 in the grid structure 111 on the middle body 11 that is the shortest distance from the bending portion 1314. Connecting the bent portion 1314 with the adjacent wave crest 1111 can not only further enhance the supporting effect on the first support body 1311, but also during expansion, the reinforcement 1313 and the grid structure 111 can pull each other and generate force on each other, which is more conducive to overall uniform expansion.

[0056] According to the pulmonary valve stent 1 provided by the above technical solution, the percentage of the total surface area of ​​each first support body 1311 to the surface area of ​​the cylinder surrounded by each unit body 131 is ≤2.5%; the percentage of the total surface area of ​​each reinforcement member 1313 to the surface area of ​​the cylinder surrounded by each unit body 131 is ≤2.0%. The surface area value refers to the total area of ​​the surface of an object, such as the surface area of ​​the first support body 1311 refers to the total area of ​​the surface of the first support body 1311. Furthermore, the sum of the surface areas of the first supports 1311 accounts for ≤2.3% of the surface area of ​​the cylinder surrounded by the unit bodies 131; the sum of the surface areas of the reinforcing members 1313 accounts for ≤1.8% of the surface area of ​​the cylinder surrounded by the unit bodies 131; further, the sum of the surface areas of the first supports 1311 accounts for ≤2.0% of the surface area of ​​the cylinder surrounded by the unit bodies 131; the sum of the surface areas of the reinforcing members 1313 accounts for ≤1.5% of the surface area of ​​the cylinder surrounded by the unit bodies 131. The sum of the surface areas of the first supports 1311 and the percentage of the surface area of ​​the cylinder surrounded by the unit bodies 131 will directly affect the axial and radial support force of the distal body 13, and the distal body 13 of the valve frame 1 cannot be well fixed in the surrounding tissue, thereby affecting the fixing effect of the valve frame 1. The ratio of the sum of the surface areas of the reinforcing members 1313 to the surface area of ​​the cylinder surrounded by the unit bodies 131 will affect the uniformity of the expansion of the unit bodies 131 and even the valve frame 1, and ultimately affect the performance of the entire valve frame 1. Therefore, setting the structures of the first support bodies 1311 and the reinforcing members 1313 within a reasonable range can improve the reliability of the valve frame 1 as a whole.

[0057] like Figure 1 and Figure 3 As shown, according to the pulmonary valve stent 1 provided by the above technical solution, the angle β formed by the bending of the first support body 1311 is 1 The size is [40°, 110°] and / or the angle β formed by the bending of the second support body 1312 2 The size of is [40°, 179°]. Specifically, the angle β formed by the bending of the first support body 1311 is 1 The size of not only affects the strength of the support, but also affects the shape of the tip formed, and thus affects the reliability of the tip piercing into the tissue. 1 The size of is set to [40°, 110°], which can better meet the use requirements. Further, the angle β formed by the bending of the first support body 1311 1 is [50°, 100°], and further, the angle β formed by the bending of the first support body 1311 1 is [60°, 90°]. The angle β formed by the bending of the second support body 1312 2 The size of the angle will affect the uniformity of the expansion of the valve frame 1 under the action of the balloon. If the angle is too large, it will be unfavorable to the peak n 1 The expansion of the support rod 1113 connected to the axial part causes the entire flap frame 1 to expand unevenly, and cannot effectively support the tissue. 2 The size is set to [40°, 179°]; further, the angle β formed by the bending of the second support body 1312 2 is [50°, 170°]; further, the angle β formed by the bending of the second support body 1312 2 The size is [60°, 160°].

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

[0059] Furthermore, if Figure 1 As shown, the valve frame 1 provided in the embodiment of the present application has two ends, namely the proximal body 12 and the distal body 13, whose diameters are slightly larger than the diameter of the middle body 11, forming a waist drum-like structure, and the diameter gradually decreases from the end to the middle waist 112, thereby further improving the fixing effect of the valve frame 1 and avoiding displacement.

[0060] like Figure 1 As 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 of the valve frame 1 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; 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 may 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 may 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 above technical solution, the valve frame 1 provided, 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, and the diameter gradually increases, and the proximal body 12 and the distal body 13 are respectively connected to the corresponding connecting bodies. 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 use 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 1As shown, according to the pulmonary valve frame 1 provided by the above technical solution, the length of the waist 112 of the valve frame 1 is 15%-60% of the total length of the valve frame 1; further, the length of the waist 112 of the valve frame 1 is 20%-40% of the total length of the valve frame 1. When the total length of the valve frame 1 is determined and unchanged, the waist 112 of different lengths will cause the lengths of the proximal body 12, the distal body 13 and the connecting portion 113 to change. If the waist 112 is set longer, there is a possibility that the length of the connecting portion 113 becomes shorter, and then the angle of inclination of the entire valve frame 1 from the waist 112 to the two ends is larger; conversely, if the waist 112 is set shorter, there is a possibility that the length of the connecting portion 113 becomes longer, and then the angle of inclination of the entire valve frame 1 from the waist 112 to the two ends is smaller. In this way, the valve frame 1 can have different shapes and a wide range of applications. In the embodiment of the present application, the length of the waist 112 is designed within the above numerical range to meet different design requirements.

[0065] like Figure 1 As shown, according to the valve frame 1 provided by the above technical solution, the angle between the line connecting the apex of the distal body 13 and the midpoint of the waist 112 and the central axis of the valve frame 1 is α 1 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 valve frame 1 is α 2 , α 1 or α 2 The size of is between (0°, 30°], where α 1 =α 2 , or α 1 ≠α 2 , or α 1 Less than α 2 .

[0066] In some embodiments of the present application, wherein α 1 and α 2 The sizes are all within the range of (0°, 30°]; and in some other embodiments of the present application, the angle α formed by the distal body 13 1 The angle α formed by the proximal body 12 is within the range of (0°, 30°). 2 is not within the range of (0°, 30°]; in some other embodiments, the angle α formed by the distal body 13 1 Not within the range of (0°, 30°], the angle α formed by the proximal body 12 2 Located in the range of (0°, 30°].

[0067] Furthermore, in some embodiments of the present application, the angle α formed by the distal body 13 is 1 The angle α formed with the proximal body 12 2 The size of α is the same, that is, 1=α 2 In some other embodiments of the present application, α 1 With α 2 The sizes of α are inconsistent, that is, 1 ≠α 2 .

[0068] Furthermore, the angle α formed by the distal body 13 1 Less than or equal to the angle α formed by the proximal body 12 2 .

[0069] In the embodiments of the present application, α 1 and α 2 By setting them at different angles, the distal body 13 and the proximal body 12 can have different expansion degrees, that is, the distal body 13 and the proximal body 12 can have different sizes, thereby meeting the use requirements of blood vessels of different sizes.

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

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

[0072] like Figure 1 and Figure 3 As shown, in the embodiment of the present application, the proximal body 12 includes a third support body 121 formed in a preset shape, and the third support body 121 is connected to the crests 1111 of the adjacent part or all of the grid structure 111. Specifically, the third support body 121 is usually set to be the same material, size, etc. as the first support body 1311, which is convenient for production and processing. It only needs to be constructed (such as bending, weaving, cutting, winding, etc.) into a preset shape according to design requirements, which can be a ring or a grid shape. According to requirements, all or part of the crests 1111 on the middle body 11 opposite to the third support body 121 are selectively connected to the third support body 121 to form different structures. Optionally, the third support body 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 crests 1111 opposite to the middle body 11.

[0073] like Figure 1 and Figure 3As shown, in some possible embodiments, the proximal body 12 further includes a connecting rod 122, and the third support body 121 is connected to the crest 1111 of the grid structure 111 through the connecting rod 122. Specifically, the third support body 121 is connected to the relative crest 1111 by providing the connecting rod 122. The provision of the connecting rod 122 is equivalent to increasing the length of the overall structure of the proximal body 12, thereby making it easier for the proximal body 12 to swell, expand into a cylinder or appear outwardly turned trumpet shape, and improve the reliability of positioning between the implanted tissue.

[0074] Further, 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, so that the proximal body 12 can be constructed into different specifications and shapes, with a wide range of applications.

[0075] According to the valve frame 1 provided by the above technical solution, the polygons formed on the distal body 13 and the proximal body 12 are irregular polygons. In some embodiments of the present application, due to the design of the pattern structure of the valve frame 1, the polygon formed by the wave structure of the proximal body 12 or the distal body 13 is naturally an irregular polygon when the force of the balloon is consistent; while in other embodiments of the present application, the wave structure of the proximal body 12 or the distal body 13 itself is designed as a regular polygon, but the outward force applied by the balloon to the proximal body 12 or the distal body 13 at different positions is different, which leads to the irregular shape of the polygon of the proximal body 12 or the distal body 13. Even in some embodiments, the polygon formed by the wave structure of the distal body 13 and the proximal body 12 is a non-planar polygon, with a certain folding curve and forming a structure with a certain three-dimensional shape.

[0076] The valve frame 1 provided in the embodiment of the present application has a radial support force of the middle body 11 of [6kPa, 140kPa], or a radial support force of the middle body 11 of [12kPa, 100kPa]; the radial support force of the proximal body 12 is [6kPa, 120kPa], the radial support force of the distal body 13 is [6kPa, 100kPa], and the deformation resistance of the distal body 13 is greater than or equal to 1.5N. The valve frame 1 is set to have a radial support force within the above-mentioned numerical range, so that the size of the support force can ensure that the valve frame 1 is easy to position on the valve ring and the leaflets are not easily washed away by the blood flow, while also avoiding the situation where the radial support force of the valve frame 1 is too large, which is not conducive to compressing the valve for delivery and is not easy to deform and cause damage to the valve ring and the aorta. The valve frame 1 has a support force performance within the above-mentioned numerical range, which better meets the use requirements and has good reliability.

[0077] In the valve frame 1 provided in the embodiment of the present application, the deformation resistance of the distal body 13 is greater than or equal to 0.5N (the deformation resistance refers to the force required when the distal body 13 is subjected to continuous pressure and undergoes irreversible deformation). The deformation resistance is within this numerical range, so that the distal body 13 has good axial support performance and has a compressive resistance that meets the use requirements. In this way, the damage caused by the irreversible deformation of the distal body 13 under pressure in the axial direction can be reduced, such as changes in the axial support position, resulting in a poor or failed support effect, or the generation of a protrusion or a sharp point toward the tissue, which pierces the tissue, and a series of uncontrollable adverse effects, which greatly improves the safety and reliability of the use of the valve frame 1.

[0078] According to the valve frame 1 provided by the above technical solution, the yield strength of the base material of the valve frame 1 is 350-1450MPa; and / or the tensile strength of the base material of the valve frame 1 is 400-1500Mpa. The base material of the valve frame 1 used in the present application has good yield strength or tensile strength, so it can ensure that the valve frame 1 has a smaller diameter and material as much as possible under the condition of achieving the corresponding radial support force, which is conducive to the delivery of the valve frame 1 in the body. When the base material of the valve frame 1 is a degradable valve frame 1, the valve frame 1 will reduce the burden of degradation / absorption in the body due to less material.

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

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

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

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

[0083] Pure metal in this application means that the total content of other impurities in the metal is less than or equal to 0.5wt.%. For example, pure iron means that the total amount of other metals and / or non-metals contained in it except iron is less than or equal to 0.5wt.%.

[0084] The embodiment of the present application also provides a pulmonary valve, including valve leaflets and the above-mentioned valve frame 1, and the valve leaflets are connected to the valve frame 1. The pulmonary valve uses the above-mentioned valve frame 1, and the above-mentioned valve frame 1 can not only expand evenly, but also has a suitable radial support force, the size of the support force can ensure that the valve frame 1 is easy to position on the valve ring, and the valve leaflets are not easily washed away by the blood flow, which greatly improves the reliability of the use of the pulmonary valve.

[0085] All data in this application refer to the corresponding values ​​of the middle part of the valve frame 1 under the nominal diameter. The "nominal diameter" refers to the diameter of the middle part of the valve frame 1 when the valve frame 1 is fully expanded under the nominal pressure, and the nominal diameter refers to the diameter of the valve frame 1 when it is fully expanded under the nominal pressure. The nominal pressure refers to the pressure required to fully expand the valve frame 1 clinically; full expansion refers to the state when the valve frame 1 is expanded to match the diameter of the lumen to which it is applied.

[0086] The X in this application 1 -X 2 The interval range indicates that the value can be X 1 , X 2 , can also be taken as X 1 and X2 Any value within the interval is a closed interval. For example, if the "wall thickness of the stent is 0.04 mm-0.5 mm" mentioned in this application, the wall thickness of the stent can be 0.04 mm, 0.5 mm, or any other value between 0.04 and 0.5 mm.

[0087] In order to facilitate the understanding of the present invention, the design points of the present invention are described below in conjunction with some specific embodiments. It can be understood that the relevant embodiments are only some examples of the solutions of the present invention and do not constitute a limitation on the scope of application.

[0088] Example 1

[0089] The present embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, the material of which is nitrided iron, with a tensile strength of 850 MPa and a yield strength of 750 MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by a combination of 18 support rods, the support rod wall thickness is 0.23 mm, and the rod width is 0.25 mm; the distal body 13 includes a first support body 1311 and a second support body 1312, forming three unit bodies 131 with an "M"-shaped profile, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 16%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 1.3% and 1.2% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 75°, and the second support angle β 2 The angle of the distal body 13 and the middle body 11 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, and the length of the connecting rod is 3.5 mm. The length of the waist 112 accounts for 20% of the total length of the valve frame 1, and the two ends of the valve frame 1 are tilted. The diameter of the middle body 11 is 20 mm, and the maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body is 1.2. The angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 8°.

[0090] The radial supporting force of the middle body 11 is 30kPa, the radial supporting force of the proximal body 12 is 25kPa, the radial supporting force of the distal body 13 is 15kPa, and the axial deformation is 3.5N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method, and the valve frame 1 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 branch.

[0091] Example 2

[0092] The present embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, the material of which is nitrided iron, the tensile strength of which is 950 MPa, and the yield strength of which is 900 MPa. The valve frame 1 comprises a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 12 support rods, the wall thickness of the support rod is 0.15 mm, and the rod width is 0.35 mm; the distal body 13 comprises a first support body 1311 and a second support body 1312, the rod width of the first support body 1311 is locally widened by 1.5 times, the first support body 1311 and the second support body 1312 constitute two unit bodies 131 with an "M"-shaped profile, a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 25%. A reinforcement member 1313 is provided, the height of the wave peak n2 is 2 / 3 of the height of the wave peak n1, and the sum of the surface areas of the first support bodies 1311 and the sum of the surface areas of the reinforcement members 1313 account for 1.2% and 0.6% of the surface area of ​​the cylinder surrounded by the unit bodies 131. The first support body angle β1 is 110°, the second support body angle β2 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, and the length of the connecting rod is 1.5 mm. The length of the waist 112 accounts for 60% of the total length of the valve frame 1. The two ends of the valve frame 1 are tilted. 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 angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 30° and 14° respectively.

[0093] The radial supporting force of the middle body 11 is 6kPa, the radial supporting force of the proximal body 12 is 6kPa, the radial supporting force of the distal body 13 is 6kPa, and the axial deformation is 1.8N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0094] Example 3

[0095] The present embodiment provides a valve frame 1 for a pulmonary valve, which is made of cobalt-chromium alloy, has a tensile strength of 1500MPa, and a yield strength of 1450MPa. The valve frame 1 includes a middle body 11, a proximal body 12, and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 18 support rods, the support rod thickness is 0.4mm, and the rod width is 0.5mm; the distal body 13 includes a first support body 1311 and a second support body 1312, forming three unit bodies 131 with an "M"-shaped profile, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 10%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 2.5% and 2.0% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 50°, the second support angle β 2 The angle of the distal body 13 and the middle body 11 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, and the length of the connecting rod is 0.8 mm. The length of the waist 112 accounts for 15% of the total length of the valve frame 1, and the two ends of the valve frame 1 are tilted. The diameter of the middle body 11 is 16 mm, and the maximum diameter ratio of the proximal body 12 and the distal body 13 to the middle body 11 is 1.2. The angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 7°.

[0096] The radial supporting force of the middle body 11 is 140kPa, the radial supporting force of the proximal body 12 is 120kPa, the radial supporting force of the distal body 13 is 100kPa, and the axial deformation is 6.2N; the valve frame 1 can be implanted in the pulmonary valve of a dog through an interventional method, 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 branch.

[0097] Example 4

[0098] The present embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, which is made of an iron-manganese alloy with a tensile strength of 1500MPa and a yield strength of 1450MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by a combination of 18 support rods, the support rod thickness is 0.4mm, and the rod width is 0.4mm; the distal body 13 includes a first support body 1311 and a second support body 1312, forming three unit bodies 131 with an "M"-shaped profile, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 11%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 2.0% and 1.5% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 75°, and the second support angle β 2 The angle of the distal body 13 and the middle body 11 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, and the length of the connecting rod is 0.8 mm. The length of the waist 112 accounts for 15% of the total length of the valve frame, and the two ends of the valve frame 1 are tilted. 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 angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 7°.

[0099] The radial supporting force of the middle body 11 is 120kPa, the radial supporting force of the proximal body 12 is 100kPa, the radial supporting force of the distal body 13 is 75kPa, and the axial deformation is 5.8N; the valve frame 1 can be implanted in the pulmonary valve of a dog through an interventional method, 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 branch.

[0100] Example 5

[0101] The present embodiment provides a valve frame 1 for a pulmonary valve, which is made of cobalt-chromium alloy, has a tensile strength of 1500MPa, and a yield strength of 1450MPa. The valve frame 1 includes a middle body 11, a proximal body 12, and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 18 support rods to form a closed ring, the support rod thickness is 0.3mm, and the rod width is 0.4mm; the distal body 13 includes a first support body 1311 and a second support body 1312, forming three unit bodies 131 with an "M"-shaped profile, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 11%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 2.0% and 1.5% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 90°, the second support angle β 2 The angle of the distal body 13 and the middle body 11 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, and the length of the connecting rod is 0.8 mm. The length of the waist 112 accounts for 15% of the total length of the valve frame, and the two ends of the valve frame 1 are tilted. 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 angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 7°.

[0102] The radial supporting force of the middle body 11 is 100kPa, the radial supporting force of the proximal body 12 is 85kPa, the radial supporting force of the distal body 13 is 70kPa, and the axial deformation is 5.2N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0103] Example 6

[0104] The present embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, the material of which is nitrided iron, with a tensile strength of 950 MPa and a yield strength of 900 MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by a combination of 24 support rods, the support rod wall thickness is 0.35 mm, and the rod width is 0.15 mm; the distal body 13 includes a first support body 1311 and a second support body 1312, forming 4 unit bodies 131 with an "M"-shaped profile, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 15%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 1.5% and 1.3% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 40°, the second support angle β 2 The angle of the distal body 13 and the middle body 11 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 by a connecting rod, and the length of the connecting rod is 3.5 mm. The length of the waist 112 accounts for 20% of the total valve frame length, and the two ends of the stent are tilted. 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 angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 9°.

[0105] The radial supporting force of the middle body 11 is 60kPa, the radial supporting force of the proximal body 12 is 45kPa, the radial supporting force of the distal body 13 is 25kPa, and the axial deformation is 4.8N; the valve frame can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0106] Example 7

[0107] The present embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, the material of which is nitrided iron, with a tensile strength of 950 MPa and a yield strength of 900 MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 18 support rods to form a closed ring, the support rod wall thickness is 0.29 mm, and the rod width is 0.4 mm; the distal body 13 includes a first support body 1311 and a second support body 1312, forming three unit bodies 131 with an "M"-shaped profile, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 17%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 1.8% and 1.6% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 40°, the second support angle β 2 The angle of the distal body 13 and the middle body 11 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, and the length of the connecting rod is 1.5 mm. The length of the waist 112 accounts for 40% of the total length of the valve frame, the two ends of the valve frame 1 are tilted, 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, and the angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 25°.

[0108] The radial supporting force of the middle body 11 is 40kPa, the radial supporting force of the proximal body 12 is 30kPa, the radial supporting force of the distal body 13 is 15kPa, and the axial deformation is 5.1N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0109] Example 8

[0110] The present embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, the material of which is nitrided iron, with a tensile strength of 900 MPa and a yield strength of 850 MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 18 support rods to form a closed ring, the support rod wall thickness is 0.4 mm, and the rod width is 0.5 mm; the distal body 13 includes a first support body 1311 and a second support body 1312, forming three unit bodies 131 with an "M"-shaped profile, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 18%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 1.6% and 1.2% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 60°, the second support angle β 2 The angle of the distal body 13 and the middle body 11 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, and the length of the connecting rod is 2.5 mm. The length of the waist 112 accounts for 25% of the total length of the valve frame, and the two ends of the valve frame 1 are tilted. 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 angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 11°.

[0111] The radial supporting force of the middle body 11 is 45kPa, the radial supporting force of the proximal body is 35kPa, the radial supporting force of the distal body is 20kPa, and the axial deformation is 6.1N; the stent can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0112] Example 9

[0113] The present embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, the material of which is nitrided iron, with a tensile strength of 850 MPa and a yield strength of 800 MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 18 support rods to form a closed ring, the support rod thickness is 0.18 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, forming three unit bodies 131 with an "M"-shaped profile, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 15%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 1.4% and 1.3% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 60°, the second support angle β 2 The angle of the distal body 13 and the middle body 11 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 by a connecting rod, and the length of the connecting rod is 2.8 mm. The length of the waist 112 accounts for 15% of the total length of the valve frame, and the two ends of the valve frame 1 are tilted. 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 angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 3°.

[0114] The radial supporting force of the middle body 11 is 12kPa, the radial supporting force of the proximal body 12 is 8kPa, the radial supporting force of the distal body 13 is 6kPa, and the axial deformation is 1.6N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0115] Example 10

[0116] The present embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, the material of which is nitrided iron, with a tensile strength of 850 MPa and a yield strength of 800 MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 18 support rods to form a closed ring, the support rod wall thickness is 0.28 mm, and the rod width is 0.18 mm; the distal body 13 includes a first support body 1311 and a second support body 1312, forming three unit bodies 131 with an "M"-shaped profile, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 13%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 1.0% and 0.9% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 60°, the second support angle β 2 The angle of the distal body 13 and the middle body 11 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 by a connecting rod, and the length of the connecting rod is 2.8 mm. The length of the waist 112 accounts for 15% of the total length of the valve frame, the two ends of the valve frame 1 are tilted, 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, and the angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 10°.

[0117] The radial supporting force of the middle body 11 is 50kPa, the radial supporting force of the proximal body 12 is 40kPa, the radial supporting force of the distal body 13 is 30kPa, and the axial deformation is 2.6N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0118] Embodiment 11

[0119] The present embodiment provides a valve frame 1 for magnesium-based absorbable pulmonary valve, which is made of magnesium alloy, has a tensile strength of 400 MPa and a yield strength of 350 MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 18 support rods to form a closed ring, and 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, and in particular, the wall thickness and rod width of the first support body 1311 are locally widened by 1.3 times, and the first support body 1311 and the second support body 1312 constitute three "M"-shaped unit bodies 131, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 14%. A reinforcement member 1313 is provided, and the wave crest n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 1.6% and 1.3% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 40°, the second support angle β 2 The angle of the distal body 13 and the middle body 11 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, and the length of the connecting rod is 1.5 mm. The length of the waist 112 accounts for 15% of the total length of the valve frame, the two ends of the valve frame 1 are tilted, 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, and the angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 10°.

[0120] The radial supporting force of the middle body 11 is 12kPa, the radial supporting force of the proximal body 12 is 8kPa, the radial supporting force of the distal body 13 is 8kPa, and the axial deformation is 2.1N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0121] Example 12

[0122] The present embodiment provides a valve frame 1 for magnesium-based absorbable pulmonary valve, which is made of magnesium alloy, has a tensile strength of 500MPa and a yield strength of 400MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 18 support rods to form a closed ring, and the wall thickness of the support rod is 0.3mm and the rod width is 0.28mm; the distal body 13 includes a first support body 1311 and a second support body 1312, and in particular, the wall thickness and rod width of the first support body 1311 are locally widened by 1.5 times, and the first support body 1311 and the second support body 1312 constitute three "M"-shaped unit bodies 131, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 13%. A reinforcement member 1313 is provided, and the wave crest n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 1.9% and 1.3% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 75°, and the second support angle β 2 The angle of the distal body 13 and the middle body 11 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, and the length of the connecting rod is 2.8 mm. The length of the waist 112 accounts for 15% of the total length of the valve frame, and the two ends of the valve frame 1 are tilted. 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 angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 10°.

[0123] The radial supporting force of the middle body 11 is 12kPa, the radial supporting force of the proximal body 12 is 8kPa, the radial supporting force of the distal body 13 is 10kPa, and the axial deformation is 2.6N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0124] Embodiment 13

[0125] The present embodiment provides a valve frame 1 for an iron-based absorbable pulmonary valve, the material of which is nitrided iron, with a tensile strength of 950 MPa and a yield strength of 900 MPa. The valve frame 1 includes a middle body 11, a proximal body 12 and a distal body 13, wherein the middle body 11 is formed by connecting a plurality of grid structures, and each grid structure in the same circumferential direction is formed by combining 18 support rods to form a closed ring, 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, and a "W"-shaped opening 132 is formed between two adjacent unit bodies 131, and the area ratio of a single opening 132 to the area formed by the distal body 13 and each opening 132 is 14%. A reinforcement member 1313 is provided, and the peak n 2 The height of the wave peak n 1 The total surface area of ​​each first support body 1311 and the total surface area of ​​each reinforcement member 1313 account for 1.1% and 0.9% of the surface area of ​​the cylinder surrounded by each unit body 131, respectively. 1 is 70°, the second support angle β 2 The angle 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, and the length of the connecting rod is 4 mm. The length of the waist 112 accounts for 15% of the total length of the valve frame, and the two ends of the valve frame 1 are tilted. 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 angle α between the line connecting the apex of the distal body 13 and the apex of the proximal body 12 and the midpoint of the waist 112 and the central axis of the middle body 11 is 1 and α 2 Both are 8°.

[0126] The radial supporting force of the middle body 11 is 55kPa, the radial supporting force of the proximal body 12 is 40kPa, the radial supporting force of the distal body 13 is 30kPa, and the axial deformation is 3N; the valve frame 1 can be implanted into the pulmonary valve of a dog through an interventional method, 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 branch.

[0127] Comparative Example 1

[0128] The design of the pulmonary valve stent in this embodiment is basically the same as that in Embodiment 1, except that in this embodiment, the distal body is not provided with a unit body with an "M"-shaped profile, and a "W"-shaped opening is not formed.

[0129] The stent can be implanted into the pulmonary valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement and can support the lumen. However, the distal end of the stent affects the distal branch blood flow, which reduces the branch blood flow.

[0130] Comparative Example 2

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

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

[0133] Comparative Example 3

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

[0135] The radial supporting force of the middle body of the stent is 6kPa, the radial supporting force of the proximal body is 6kPa, the radial supporting force of the distal body is 6kPa, and the axial deformation is only 0.5N; the stent can be implanted into the pulmonary valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement, can support the lumen, and does not affect the blood flow of the distal branch, but the distal body undergoes axial deformation and twists and punctures the blood vessel.

[0136] Comparative Example 4

[0137] The design of the pulmonary valve stent in this embodiment is basically the same as that in Embodiment 2, except that the first support angle β in this embodiment is 1 is 30°, the second support angle β 2 is 30°.

[0138] The radial supporting force of the middle part of the stent is only 4kPa, the radial supporting force of the proximal part is only 3kPa, the radial supporting force of the distal part is only 2kPa, and the axial deformation is 1.6N; the stent can be implanted into the pulmonary valve of a dog through an interventional method. The stent can be well fixed in the lumen without displacement, but the stent supporting force is low and cannot support the blood vessels. After the balloon is relieved of pressure, the stent is collapsed by the blood vessels.

[0139] Comparative Example 5

[0140] The design of the pulmonary valve stent 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 radial supporting force of the middle part of the stent is 28kPa, the radial supporting force of the proximal part is 20kPa, the radial supporting force of the distal part is 12kPa, and the axial deformation is 2.6N; the stent can be implanted into the pulmonary valve of a dog through an interventional method, and the stent can be well fixed in the lumen without displacement, but the uneven expansion of the stent leads to uneven distribution of the valve, the valve cannot be completely closed, and regurgitation occurs.

[0142] The above is only a preferred specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by any technician familiar with the technical field within the technical scope disclosed in the present application should be included in the protection scope of the present application.

Claims

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

2. The valve frame according to claim 1, characterized in that: The unit body includes a first support body and a second support body connected to each other at one end, and one end where the first support body and the second support body are connected is connected to the middle body.

3. The valve frame according to claim 1, characterized in that: A "W"-shaped opening is formed between two adjacent unit bodies, and the ratio of the area of ​​a single opening to the area of ​​a region formed by the distal body and the openings is ≥10%.

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

5. The valve frame according to claim 2, characterized in that: The grid structure is composed of wave crests, wave troughs, and support rods connecting the wave crests and the wave troughs, and one end where the first support body and the second support body are connected is connected to the adjacent wave crest.

6. The valve frame according to claim 2, characterized in that: The width of the first support body is 1.0-3.5 times the width of the second support body.

7. The valve frame according to claim 5, characterized in that: The unit body further includes a reinforcing member, which is disposed between the middle body and the distal body, and is connected to at least the first supporting body.

8. The valve frame according to claim 7, characterized in that: The total surface area of ​​each of the first supporting bodies accounts for ≤2.5% of the cylindrical side surface area surrounded by the combination of the unit bodies, and the total surface area of ​​each of the reinforcing members accounts for ≤2.0% of the cylindrical side surface area surrounded by the combination of the unit bodies.

9. The valve frame according to claim 7, characterized in that: A bending portion is formed on the reinforcement, and the bending portion is connected to the adjacent wave crests on the middle body.

10. The valve frame according to claim 5, characterized in that: The size of the angle formed by the bending of the first support body is [40°, 110°] and / or the size of the angle formed by the bending of the second support body is [40°, 179°].

11. 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.

12. The valve 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 and having a gradually increasing diameter. The proximal body and the distal body are respectively connected to the corresponding connecting portions.

13. The valve frame according to claim 12, characterized in that: 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.

14. The valve frame according to claim 1, 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, and the size of α1 or α2 is between (0°, 30°], where α1=α2, or α1≠α2, or α1 is less than α2.

15. The valve frame according to claim 5, characterized in that: The proximal body includes a third support body formed in a preset shape, and the third support body is connected to adjacent parts or all of the wave crests of the grid structure.

16. The valve frame according to claim 15, characterized in that: The proximal body further comprises a connecting rod, and the third supporting body is connected to the wave crest of the grid structure via the connecting rod.

17. The valve frame according to claim 16, characterized in that: The length of the connecting rod is 0.8mm-4mm.

18. The valve holder according to any one of claims 1 to 17, characterized in that: The radial supporting force of the middle body is [6kPa, 140kPa], the radial supporting force of the proximal body is [6kPa, 120kPa], the radial supporting force of the distal body is [6kPa, 100kPa], and the deformation resistance of the distal body is greater than or equal to 1.5N.

19. The valve holder according to any one of claims 1 to 17, characterized in that: The material of the base material of the valve frame includes a degradable material, and / or the material of the base material of the valve frame includes at least any one of pure iron, iron alloy, pure magnesium, magnesium alloy, pure zinc or zinc alloy.

20. A pulmonary valve, characterized in that: It comprises a valve leaflet and a valve frame as described in any one of claims 1 to 19, wherein the valve leaflet is connected to the valve frame.

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