Paravalvular leak prevention material, paravalvular leak prevention device, paravalvular leak prevention skirt, mold, prosthetic heart valve, prosthetic implant, and related method

Abstract

The present application discloses a paravalvular leak prevention material, a paravalvular leak prevention device, a paravalvular leak prevention skirt, a mold, a prosthetic heart valve, a prosthetic implant, and a related method. The prosthetic implant comprises: a stent having a radially-deformable cylindrical structure, the stent being provided with a through blood flow passage; a plurality of valve leaflets, each valve leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the stent, and the free edge is used for controlling the blood flow passage; and a paravalvular leak prevention structure arranged in the circumferential direction of the stent, the paravalvular leak prevention structure being: a blocking component that at least partially radially protrudes (extends) out of the stent and uses a deformable structure; and / or an outer skirt wrapped around the outer periphery of the stent. The paravalvular leak prevention structure of the present application can make an inflow end of the stent have an adaptive blocking effect, thereby reducing paravalvular leak.

Description

Anti-leakage material, anti-leakage device, anti-leakage skirt, mold, artificial heart valve, artificial implant and related methods Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an anti-leakage material, an anti-leakage device, an anti-leakage skirt, a mold used therein, an artificial heart valve prepared therefrom, an artificial implant, and related methods. Background Art

[0002] Heart valve replacement is widely used clinically as an effective treatment for valvular heart disease. Paravalvular leakage (PVL) is a non-structural valvular dysfunction that often occurs in the early and late stages after prosthetic valve replacement. Currently, the two main treatments for paravalvular leakage are surgery and interventional therapy. Although surgical treatment is becoming increasingly mature, the complications and mortality rates of repeat surgeries are significantly increased, and the incidence of recurrent PVL is high. While interventional therapy can effectively reduce the severity of PVL and improve its symptoms, reoperation still carries certain risks. Technical issues

[0003] Currently, some technicians are focusing on reducing the incidence of paravalvular leakage by adding a skirt to the inflow end of the valve to block the leaking area. Skirt materials used are mainly divided into biological skirts and polymer skirts. However, existing skirt designs lack adaptive adjustment capabilities. Technicians often increase the skirt thickness to prevent leakage, but this increases the delivery device's access port size and can easily damage the skirt if the valve is repeatedly retrieved during the interventional delivery process. Technical Solutions

[0004] In order to solve the problem of paravalvular leakage after an artificial implant is implanted in the body, the present application provides an artificial implant, comprising:

[0005] The stent is a radially deformable cylindrical structure having a through blood flow channel;

[0006] A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel;

[0007] The anti-circumferential leakage structure is arranged along the circumference of the bracket, and the anti-circumferential leakage structure is:

[0008] At least a portion of the occluding component radially protrudes (extends) from the stent and the occluding component includes a deformable structure; and / or

[0009] An outer skirt wrapped around the outer periphery of the bracket.

[0010] Optionally, the artificial implant further comprises an inner skirt located radially inward of the stent, and the blocking component is an integral structure with at least one of the inner skirt and the outer skirt, or is wrapped in a radial gap between the two.

[0011] The present application also provides an artificial implant, comprising:

[0012] The stent is a radially deformable cylindrical structure having a through blood flow channel;

[0013] A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel;

[0014] A blocking component adopts a deformable structure and is continuously distributed along the circumference as a whole and is arranged around the outer periphery of the stent, and at least a portion of the blocking component radially protrudes outward from the stent;

[0015] The skirt includes an inner skirt located on the inner side of the bracket and an outer skirt located on the radial outside of the bracket. The sealing component is an integral structure with at least one of the inner skirt and the outer skirt, or is wrapped in the radial gap between the two. The sealing component is fixed to the inner skirt through the hollow part of the bracket grid and wraps at least a part of the frame bar constituting the bracket grid.

[0016] The present application also provides an artificial implant, comprising:

[0017] The stent is a radially deformable cylindrical structure having a through blood flow channel;

[0018] A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel;

[0019] The skirt comprises an inner skirt located on the radial inner side of the bracket and an outer skirt located on the radial outer side of the bracket. The inner skirt and the outer skirt are an integrated structure and are made of PU material.

[0020] The present application also provides an artificial implant, comprising:

[0021] The stent is a radially deformable cylindrical structure with a through-going blood flow channel;

[0022] Multiple leaflets, each leaflet having a fixed edge and a free edge relative to each other, wherein the fixed edge is fixed to the stent and the free edge is used to control the blood flow channel;

[0023] The blocking component adopts a deformable structure and is arranged along the circumference of the stent, and at least a portion of the blocking component radially protrudes outward from the stent;

[0024] The skirt, relative to the radial position of the stent, includes an inner skirt and an outer skirt, the inner skirt and the outer skirt are connected on the inflow side of the stent to form a pouch structure, at least a portion of the stent and at least a portion of the blocking component are located in the pouch structure.

[0025] The inner skirt and the outer skirt are connected as one piece or as a separate piece at the inflow side of the bracket. For example, the inner skirt and the outer skirt are both made of PU material and are connected as an integral structure at the inflow side of the bracket.

[0026] Alternatively, the inner skirt is made of PU and the outer skirt is made of PET fabric. Alternatively, both the inner skirt and the outer skirt are made of PET fabric.

[0027] Optionally, the pouch structure extends continuously along the circumference of the stent, or the pouch structure is arranged at intervals along the circumference of the stent, for example, at 3 to 6 locations.

[0028] Optionally, all the blocking components are placed in the pouch structure. The outer skirt can provide additional protection for the blocking components and cooperate with the anti-leakage effect of the radial outward convexity. The relatively smooth surface of the outer skirt can reduce friction resistance during loading or delivery.

[0029] The present application also provides an artificial implant, comprising:

[0030] The stent is a radially deformable cylindrical structure having a through blood flow channel;

[0031] A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel;

[0032] A skirt, comprising an inner skirt located radially inwardly of the stent and / or an outer skirt located radially outwardly of the stent;

[0033] The blocking component adopts a deformable structure and is arranged along the circumference of the bracket. At least a part of the blocking component radially protrudes outward from the bracket. The blocking component and the outer skirt are an integral structure and the blocking component is located outside the outer skirt.

[0034] The present application also provides an artificial implant, comprising:

[0035] The stent is a radially deformable cylindrical structure having a through blood flow channel;

[0036] A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel;

[0037] A skirt, comprising an inner skirt located radially inwardly of the stent and / or an outer skirt located radially outwardly of the stent;

[0038] a sealing assembly, which adopts a deformable structure and is arranged along the circumference of the stent, at least a portion of which radially protrudes outward from the stent, and the sealing assembly is an integral structure with at least one of the inner skirt and the outer skirt, or is wrapped in a radial gap between the two;

[0039] The blocking assembly comprises a plurality of blocking blocks, which are spaced apart and arranged in groups along the circumference of the stent. Each group contains at least one blocking block, and adjacent groups are separated by spacing zones. All blocking blocks avoid each spacing zone along the circumference of the stent. That is, the distribution area of ​​all the blocking blocks is spaced apart along the circumference of the stent.

[0040] The present application also provides an artificial implant, comprising:

[0041] The stent is a radially deformable cylindrical structure having a through blood flow channel;

[0042] A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel;

[0043] A skirt, comprising an inner skirt located radially inwardly of the stent and / or an outer skirt located radially outwardly of the stent;

[0044] a sealing assembly, which adopts a deformable structure and is arranged along the circumference of the stent, at least a portion of which radially protrudes outward from the stent, and the sealing assembly is an integral structure with at least one of the inner skirt and the outer skirt, or is wrapped in a radial gap between the two;

[0045] The blocking assembly is a plurality of blocking blocks embedded in the bracket grid. The blocking blocks in two circumferentially adjacent bracket grids are staggered along the axial direction of the bracket. Along the axial direction of the bracket, the two sides of the blocking block itself are opposite wide sides and narrow sides, and the wide sides of the blocking blocks in two adjacent bracket grids are opposite to each other.

[0046] The present application also provides an artificial implant, comprising:

[0047] The stent is a radially deformable cylindrical structure having a through blood flow channel;

[0048] A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel;

[0049] A skirt, comprising an inner skirt located radially inwardly of the stent and / or an outer skirt located radially outwardly of the stent;

[0050] The sealing component adopts a deformable structure and is arranged along the circumference of the stent. At least a part of the sealing component protrudes radially outward from the stent. The sealing component is an integral structure with at least one of the inner skirt and the outer skirt, or is wrapped in the radial gap between the two. The sealing component forms at least two circles of wave peaks on the outer circumference of the stent. The two circles of wave peaks are arranged axially along the stent and form a trough area between each other that can accommodate the native valve ring. The same circle of wave peaks is a plurality of sealing blocks arranged at intervals along the circumference or a sealing ring distributed continuously along the circumference.

[0051] The present application also provides an artificial implant, comprising:

[0052] The stent is a radially deformable cylindrical structure having a through blood flow channel;

[0053] A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel;

[0054] A skirt, comprising an inner skirt located radially inwardly of the stent and / or an outer skirt located radially outwardly of the stent;

[0055] a sealing assembly, which adopts a deformable structure and is arranged along the circumference of the stent, at least a portion of which radially protrudes outward from the stent, and the sealing assembly is an integral structure with at least one of the inner skirt and the outer skirt, or is wrapped in a radial gap between the two;

[0056] A reinforcement is pre-embedded in the skirt and connected to the bracket via a suture passing through the reinforcement, and the reinforcement avoids the blocking component.

[0057] The present application also provides an artificial implant, comprising:

[0058] The stent is a radially deformable cylindrical structure having a through blood flow channel;

[0059] A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel;

[0060] A skirt, comprising an inner skirt located radially inwardly of the stent and / or an outer skirt located radially outwardly of the stent;

[0061] a sealing assembly, which adopts a deformable structure and is arranged along the circumference of the stent, at least a portion of which radially protrudes outward from the stent, and the sealing assembly is an integral structure with at least one of the inner skirt and the outer skirt, or is wrapped in a radial gap between the two;

[0062] The developing marker is pre-embedded in the skirt and / or the occlusion component, and the joint between adjacent leaflets at the stent position is a joint part. The circumferential position of the developing marker corresponds to each joint part. The developing marker is at least a group, and the axial position of this group is adjacent to the inflow side of the stent, and the axial distance between the leaflet and the leaflet can at least accommodate the native valve ring.

[0063] Optionally, the bracket has an inflow side and an outflow side opposite to each other, and the outer skirt is arranged on the inflow side; the bracket has a bracket grid, and the axial span of the outer skirt is 0.5 to 2 grids.

[0064] Optionally, the outer skirt has an inflow edge and an outflow edge, and along the axial direction of the stent, the outflow edge of the outer skirt is adjacent to the midpoint of the fixed edge of the leaflet and does not exceed the outflow side of the midpoint.

[0065] Optionally, the bracket as a whole has a waist portion, and the outflow edge of the outer skirt is located at the waist portion.

[0066] Optionally, the bracket as a whole has a waist portion, and the distance between the outflow edge of the outer skirt and the waist portion is 0.5 to 1 grid.

[0067] Optionally, a bag structure is formed between the outer skirt and the inner skirt, and the blocking component is located in the bag structure.

[0068] Optionally, along the radial direction of the stent, the pouch structure is 0.5 to 20 mm higher than the outer peripheral wall of the stent.

[0069] Optionally, the pouch structure is a fully enclosed structure.

[0070] Optionally, the pouch structure is a semi-open structure, and the open portion is an opening facing the inflow side and / or the outflow side.

[0071] Optionally, the openings are multiple and arranged at intervals along the circumference of the bracket.

[0072] Optionally, the material of the inner skirt and the outer skirt is:

[0073] All made of PU material, or

[0074] One is made of PU and the other is made of biomaterial, or

[0075] All are biological materials.

[0076] Optionally, the inner skirt and the outer skirt both have an inflow edge and an outflow edge, the outflow edge of the inner skirt is connected to the fixed edges of the multiple leaflets, the inner skirt is made of a first sheet material, and the outer skirt is made of a second sheet material, and the inner skirt and the outer skirt are constructed as follows:

[0077] A first sheet material is fixed to the inner side of the bracket, a second sheet material is fixed to the outer side of the bracket, and the inflow end of the bracket is exposed; or

[0078] A first sheet is fixed on the inner side of the bracket, the first sheet is turned outward on the inflow side of the bracket and wraps the inflow end of the bracket, and a second sheet is fixed on the outer side of the bracket and connected to the turned-out portion of the first sheet; or

[0079] A second sheet is fixed on the outside of the bracket, the second sheet is turned inward on the inflow side of the bracket and wraps the inflow end of the bracket, and a first sheet is fixed on the inside of the bracket and connected to the inverted part of the second sheet; or

[0080] A first sheet is fixed on the inner side of the bracket, and a second sheet is fixed on the outer side of the bracket. The first sheet and the second sheet are an integrated structure and wrap the inflow end of the bracket.

[0081] The blocking component is an integral structure with one of the first sheet and the second sheet, or is bonded to at least one of them, or is clamped between the two, and the blocking component is radially located inside or outside the second sheet.

[0082] Optionally, the inflow edge of the inner skirt and the inflow edge of the outer skirt are roughly aligned, and the two are an integral structure or a separate connection to close the blood flow channel; the radial position of the blocking component is on the inner side or the outer side of the outer skirt.

[0083] Optionally, the shapes of the inflow edges of the inner skirt and the outer skirt are independent of each other, and both have a smooth inflow edge or an inflow edge adapted to the shape of the support grid.

[0084] Optionally, the outflow edge of the outer skirt extends smoothly along the circumference of the stent, or has axial undulations while extending along the circumference of the stent.

[0085] Optionally, the degree of the axial undulation matches the shape of the frame bars of the stent grid, or matches the shape of the axial edge of the occluding component.

[0086] Optionally, the first sheet material and / or the second sheet material is made of PU material and has a thickness of 0.02 to 0.2 mm.

[0087] Optionally, the blocking component is made of PU, and is made of the same material as at least one of the first sheet and the second sheet, and forms an integral structure.

[0088] Optionally, the first sheet material is made of PU material, and the second sheet material is made of PET fabric.

[0089] Optionally, the inner skirt and the outer skirt are connected and fixed to each other by at least one of bonding or sewing.

[0090] Optionally, the inner skirt and the outer skirt are fixed continuously or at intervals along the circumference of the bracket. For example, the outflow side of the outer skirt and the portion corresponding to the inner skirt are fixed in the above-mentioned continuous or interval manner.

[0091] Optionally, the blocking component is made of PU or other polymer materials.

[0092] Optionally, the deformable structure of the blocking component may have internal voids, for example, a foam structure with a pore size of 5 to 500 microns and a porosity of 40 to 95%.

[0093] Optionally, the blocking component may also be a material that expands after absorbing water.

[0094] Optionally, the blocking component arrangement includes:

[0095] comprising a plurality of blocking blocks arranged along the circumference of the stent; or

[0096] The blocking component is an annular component as a whole and is located on the outer periphery of the bracket. The blocking component is directly sleeved on the outer periphery of the bracket; or directly sleeved on the outer periphery of the outer skirt.

[0097] Optionally, the plurality of blocking blocks are arranged in multiple groups spaced apart along the circumference of the stent, with each group containing at least one blocking block. Adjacent groups are separated by spacers, and all blocking blocks avoid the spacers along the circumference of the stent. That is, the distribution areas of all the plurality of blocking blocks are spaced apart along the circumference of the stent.

[0098] Optionally, the blocking blocks are in two to nine groups, for example, three to six groups, and the groups are evenly distributed along the circumference of the stent.

[0099] Optionally, there are 1 to 10 blocking blocks in the same group, and the distribution area of ​​the blocking blocks in the same group is continuously distributed in the circumferential direction of the stent.

[0100] Optionally, the distribution areas of all the multiple blocking blocks are continuously distributed in the circumferential direction of the stent.

[0101] Optionally, the radial position of the blocking blocks is located inside the outer skirt, and each blocking block is embedded in a corresponding stent grid or randomly filled between the two skirts.

[0102] Optionally, the same grid may include only one continuously distributed blocking block, or may include multiple blocks arranged at intervals.

[0103] Optionally, the support grid is multi-circle, and all the blocking blocks are distributed only in the same circle.

[0104] Optionally, the blocking blocks in two adjacent stent grids are staggered along the axial direction of the stent.

[0105] Optionally, along the axial direction of the stent, two sides of the blocking block itself are opposite wide sides and narrow sides, and the blocking blocks in two adjacent stent grids have opposite wide sides.

[0106] Optionally, the wide sides of all the blocking blocks are connected to each other and extend continuously along the circumference of the stent.

[0107] Optionally, along the radial viewing angle of the stent, the shape of the blocking block is circular, elliptical, rectangular, diamond-shaped, triangular or hexagonal.

[0108] Optionally, each blocking block is embedded in a corresponding stent grid, and along the radial viewing angle of the stent, the blocking block is distributed throughout the stent grid, or is only distributed in a partial area of ​​the stent grid.

[0109] Optionally, the blocking blocks are distributed in the central area of ​​the stent grid, or close to one axial end.

[0110] Optionally, the same stent grid is provided with two blocking blocks spaced apart in the axial direction, and each blocking block is adjacent to one axial end of the stent grid.

[0111] Optionally, in the longitudinal section of the blocking block, the blocking block has an inner side facing the bracket and an opposite outer side (the inner side is in contact with the skirt), and the outer edge shape is a broken line, a smooth curve or a combination of the two.

[0112] Optionally, the outer edge of the blocking block is a broken line, and the longitudinal section of the blocking block is generally triangular, rectangular or trapezoidal.

[0113] Optionally, the outer edge of the blocking block is a smooth curve and has a radially highest point (roughly at the location of maximum thickness of the blocking block), and the axial position of the highest point in the stent grid is closer to the inflow side.

[0114] Optionally, along the radial direction of the stent, the thickness of the blocking block is uniform or non-uniformly distributed, wherein the maximum thickness is 0.5 to 5 mm.

[0115] Optionally, the blocking component as a whole spans 0.5 to 3 grids in the axial direction, for example, 0.5 to 2 grids.

[0116] Optionally, the longitudinal cross-section shape (outer contour) of the annular member is circular, truncated circle (such as semicircle), trapezoidal, rectangular, elliptical or B-shaped, triangular, etc.

[0117] Optionally, the installation position of the blocking component is:

[0118] The blocking component is fixed to the inner skirt and protrudes from the radial inner side of the stent to the radial outer side of the stent through the corresponding grid, and the outer skirt surrounds the outer side of the blocking component; or

[0119] The blocking component is fixed to the inner side of the outer skirt and is located in the sandwich layer between the outer skirt and the inner skirt; or

[0120] The blocking component is fixed to the outer side of the outer skirt.

[0121] Optionally, the outer skirt surrounds the outside of the blocking component, and the outer skirt wraps all or part of the blocking component.

[0122] Optionally, in the longitudinal section of the sealing component, the outer edge shape of the sealing component has two peaks and a trough between the two peaks (such as the B shape mentioned above), and the outflow side of the outer skirt is located at the trough.

[0123] Optionally, the outer skirt and the inner skirt are connected to the bracket via sutures, at least one of the outer skirt and the inner skirt is provided with a reinforcement, and the sutures pass through the reinforcement.

[0124] Optionally, the reinforcement member is a suture reinforcement line or reinforcement fabric pre-embedded in the skirt, or the reinforcement member is a reinforcement gasket directly abutting the outer skirt and / or the inner skirt.

[0125] Optionally, the reinforcement is made of PU or PET.

[0126] Optionally, the reinforcing gasket is located on the outer side of the outer skirt or the inner side of the inner skirt, or radially between the outer skirt and the inner skirt.

[0127] Optionally, the reinforcing gasket and the skirt against which it abuts are an integral structure or are fixed separately.

[0128] Optionally, at the junction of the inner skirt and the leaflet, the reinforcing gasket, the leaflet, and the inner skirt are stacked and fixed in any order.

[0129] Optionally, the reinforcement is distributed over the entire inner skirt or only on the outflow side of the inner skirt and engages with the fixed edge of the leaflet, that is, the edge of the reinforcement is aligned with the outflow side of the inner skirt.

[0130] Optionally, the reinforcement avoids or passes through the blocking component; the suture avoids or passes through the blocking component.

[0131] Optionally, the suture reinforcement line extends along the circumference of the stent to form a line loop, and the line loop is one or more circles, wherein the multiple circles of the line loop are arranged at intervals or extend continuously in a spiral manner.

[0132] Optionally, at least one of the outer skirt, the inner skirt, the sealing assembly, and the reinforcement is pre-embedded with a developing mark.

[0133] Optionally, the formation of the development mark includes at least one of the following methods:

[0134] The development mark is pre-formed and serves as an embedded part in the synthesis process;

[0135] The development mark is mixed into at least one raw material in the synthesis process.

[0136] Optionally, the development mark is in the form of strips, powder, flakes or blocks.

[0137] Optionally, the imaging mark is in the shape of a strip and extends along the axial direction or circumferential direction of the stent (to indicate the position and direction).

[0138] Optionally, the sealing assembly is an annular member, and the developing marks are arranged along the circumference of the annular member.

[0139] Optionally, the blocking component is a plurality of blocking blocks, wherein at least two (eg, three to six or even more) of the blocking blocks are provided with development marks.

[0140] Optionally, the development mark is located in the central area (center point or center line) of the blocking block.

[0141] Optionally, the development mark includes a first mark and a second mark, and the two marks are respectively located at corresponding wave peaks.

[0142] Optionally, the development mark is located at a trough.

[0143] Optionally, the joint portion of two circumferentially adjacent leaflets on the stent is a joint portion, and the development marks are in multiple groups, and each group matches a corresponding joint portion position along the circumference of the stent.

[0144] Optionally, along the axial direction of the stent, the development mark is adjacent to the inflow side of the stent.

[0145] The present application combines a skirt with a self-expanding plugging component, and can utilize the good shape adaptability of the plugging component to improve the anti-circumferential leakage effect.

[0146] In order to solve the problem of peripheral leakage after the artificial implant is implanted in the body, the present application also provides an artificial implant anti-peripheral leakage device. The anti-peripheral leakage device can also be understood as a further improvement of the above-mentioned blocking component, that is, using a pull line (one of the forms of reinforcement mentioned above) to connect multiple blocking blocks.

[0147] The present application provides a device for preventing peripheral leakage of an artificial implant, wherein the artificial implant has a cylindrical support with a grid structure, and the device for preventing peripheral leakage comprises:

[0148] A plurality of blocking blocks are arranged along the circumference of the stent, each blocking block adopting a deformable structure and embedded in a grid structure corresponding to a position;

[0149] A pulling wire is used to connect the blocking blocks to each other.

[0150] Optionally, in correspondence with the grid structure, the blocking blocks are arranged in multiple circles, each circle is arranged along the axial direction of the stent, and adjacent circles are staggered with each other.

[0151] Optionally, the blocking blocks in the same circle are connected only by the pulling wire.

[0152] Optionally, connecting strips integrally formed with the blocking blocks are provided between adjacent blocking blocks in the same circle.

[0153] Optionally, the blocking block completely fills the grid structure in which it is located.

[0154] Optionally, the blocking block partially fills the grid structure where it is located.

[0155] Optionally, the blocking blocks are arranged in two circles, wherein the first circle completely fills the grid structure, and the second circle partially fills the grid structure.

[0156] Optionally, in the first circle, there is a spacing portion between two adjacent blocking blocks, and each blocking block in the second circle is located at a corresponding spacing portion.

[0157] Optionally, along the axial direction of the stent, the grid structure has a central area and edge areas on both sides of the central area; along the radial direction of the stent, the thickness of the blocking block decreases from the central area of ​​the grid area to the edge area, and along the circumference of the stent, the width of the blocking block decreases from the central area of ​​the grid area to the edge area.

[0158] Optionally, the blocking block is a porous structure.

[0159] Optionally, the blocking block is made of foamed PU.

[0160] Optionally, the porosity of the blocking block is 50-85.

[0161] Optionally, along the radial direction of the stent, the anti-leakage device has an inner side and an outer side relative to each other, and the pull line is located close to the inner side.

[0162] Optionally, the pulling wire is located on the inner side of the stent, and the blocking block protrudes from the outer peripheral surface of the stent.

[0163] Optionally, the anti-circumferential leakage device has a curled state wrapped around the bracket and a relatively straightened state. In the straightened state, a plurality of pulling wires are provided according to their own extension direction.

[0164] Optionally, at least one pull wire passes through all the blocking blocks.

[0165] Optionally, the blocking blocks are arranged in multiple circles, and the circles are arranged axially along the stent, and at least one pulling wire passes through all the blocking blocks in one circle.

[0166] Optionally, the two pulling lines are parallel to each other.

[0167] Optionally, two of the pulling lines intersect.

[0168] Optionally, at least one of the pulling lines extends along the length direction of the peripheral leakage prevention device.

[0169] Optionally, at least one of the pulling lines extends along the length direction of the leakage prevention device in the straightened state.

[0170] Optionally, at least two of the pulling lines extend along the length direction of the leakage prevention device in the straightened state.

[0171] Optionally, the pulling wires include at least two groups, each group includes multiple pulling wires parallel to each other, one group extends along the length direction of the anti-peripheral leakage device, and the other group extends along the width direction of the anti-peripheral leakage device.

[0172] Optionally, the pulling wires with different extension directions belong to the same wire and are arranged in a circuitous manner.

[0173] Optionally, the blocking blocks are arranged in one or more circles corresponding to the grid structure, and at least one pull line passes through the same circle of blocking blocks and extends along the length of the peripheral leakage prevention device in the straightened state. Preferably, there are at least two pull lines passing through the same circle of blocking blocks.

[0174] Optionally, along the width direction of the peripheral leakage prevention device in the straightened state, among the pulling lines passing through the blocking blocks in the same circle, at least one is adjacent to the middle area of ​​the blocking blocks.

[0175] Optionally, a limiting component is fixed on the pulling wire, and the limiting component is embedded in the blocking block.

[0176] Optionally, the limiting component is a knot.

[0177] Optionally, the limiting component further includes a circuitous structure connected to the knot.

[0178] Optionally, the pulling wires are all connected through the limiting component.

[0179] Optionally, the pull wire is made of PTFE.

[0180] Optionally, the anti-circumferential leakage device further comprises an inner lining film. In a curled state, the inner lining film is located on the inner side, and each blocking block is fixed on the outer side of the inner lining film.

[0181] Optionally, there is a spacing portion between two adjacent blocking blocks in the same circle, and a portion of the pulling wire is located at the spacing portion on its own extension path, and the portion is fitted and fixed to the lining membrane.

[0182] Optionally, the lining membrane and the blocking block are made of the same material.

[0183] Optionally, the thickness of the lining film is 0.1 to 0.5 mm.

[0184] The present application provides a device for preventing peripheral leakage of an artificial implant, wherein the artificial implant has a cylindrical support with a grid structure, and the device for preventing peripheral leakage comprises:

[0185] A plurality of blocking blocks are arranged along the circumference of the stent, each blocking block adopting a deformable structure and embedded in a grid structure corresponding to a position;

[0186] The lining film, the plurality of blocking blocks are fixed on one side of the lining film, and the lining film and the plurality of blocking blocks are made of the same material.

[0187] The present application provides an artificial implant, comprising a stent and a peripheral leakage prevention device wrapped around the stent, wherein the stent is cylindrical and has a grid structure, and the peripheral leakage prevention device comprises:

[0188] Multiple blocking blocks are arranged along the circumference of the artificial implant, each blocking block adopts a deformable structure and is embedded in a grid structure corresponding to the position;

[0189] Pulling wires, through which the blocking blocks are connected to each other to form a peripheral leakage prevention device.

[0190] Or the anti-circular leakage device includes:

[0191] A plurality of blocking blocks are arranged along the circumference of the stent, each blocking block adopting a deformable structure and embedded in a grid structure corresponding to a position;

[0192] The lining film, the plurality of blocking blocks are fixed on one side of the lining film.

[0193] Optionally, the lining membrane and the plurality of blocking blocks are made of the same material.

[0194] Optionally, the artificial implant is an artificial heart valve.

[0195] The present application provides a method for processing an artificial implant, comprising:

[0196] A bracket and a peripheral leakage prevention device are provided respectively. The bracket is cylindrical and has a grid structure. The peripheral leakage prevention device includes:

[0197] There are multiple occluding blocks arranged along the circumference of the artificial implant, and each occluding block adopts a deformable structure;

[0198] Pulling wires, through which the blocking blocks are connected to each other to form a peripheral leakage prevention device;

[0199] The processing method comprises:

[0200] The anti-leakage device is curled up and connected end to end to form a curled state;

[0201] The anti-circumferential leakage device in a curled state is fixed to the bracket, and each blocking block is embedded in the grid structure corresponding to the position during the fixing.

[0202] The present application provides a method for processing an artificial implant, comprising:

[0203] A bracket and a peripheral leakage prevention device are provided respectively. The bracket is cylindrical and has a grid structure. The peripheral leakage prevention device includes:

[0204] There are multiple occluding blocks arranged along the circumference of the artificial implant, and each occluding block adopts a deformable structure;

[0205] Pulling wires, through which the blocking blocks are connected to each other to form a peripheral leakage prevention device;

[0206] The processing method comprises:

[0207] placing a portion of the anti-leakage device in the length direction inside or outside the bracket and fixing it to the bracket;

[0208] The remaining parts of the anti-circular leakage device are gradually fixed to the bracket until the anti-circular leakage device is connected end to end in a curled state, and each blocking block is embedded in the grid structure corresponding to the position when fixed.

[0209] The present application provides a mold for forming an anti-circumferential leakage device, comprising a body, a working surface on one side of the body, and a mold provided on the working surface:

[0210] Multiple mold cavities for forming blocking blocks;

[0211] The wire groove intersects with the mold cavity and is used for passing the pulling wire. The formed blocking blocks are connected by the pulling wire to form the anti-circular leakage device.

[0212] Optionally, the wire groove is open on the working surface.

[0213] Optionally, the wire groove extends to the edge of the body.

[0214] Optionally, the wire groove extends along a straight line.

[0215] The present application provides a mold for forming an anti-circular leakage device, comprising:

[0216] A main body, a working surface on one side of the main body, and a plurality of mold cavities are opened on the working surface for forming the blocking block;

[0217] A forming frame is superimposed on the working surface and surrounds the outer periphery of the mold cavity opening.

[0218] Optionally, the forming frame and the body are of separate structures or integrated structures. The forming frame and the wire trough can be combined with each other.

[0219] Optionally, the working surface has a sedimentation area, and the multiple mold cavities are located in the sedimentation area.

[0220] Optionally, the depth of the sedimentation zone and the thickness of the forming frame both correspond to the thickness of the lining film.

[0221] The present application provides a method for forming an anti-circular leakage device using a mold, comprising:

[0222] Adding sealing block raw materials into multiple mold cavities of the mold;

[0223] Laying a pull wire, wherein an extension path of the pull wire intersects with the mold cavity;

[0224] The blocking block material is solidified under predetermined conditions; and the blocking blocks formed and connected by the pulling wires are demoulded to obtain the anti-circular leakage device.

[0225] Optionally, adding the blocking block material and laying the pull wire are performed in any order, or alternately.

[0226] Optionally, the material of the blocking block is in a fluid or paste state, and is leveled or scraped to be at the same height as the working surface.

[0227] Optionally, before solidifying the blocking block material, a lining film material is used to form a coating on the top side of the blocking block material, and then the lining film material and the blocking block material are solidified simultaneously.

[0228] Optionally, at least one of the blocking block material and the lining membrane material is in a paste form.

[0229] Optionally, the blocking block raw material contains solid particles, and the method further comprises removing the solid particles after demoulding.

[0230] Optionally, the curing temperature is 10-60°C, and the curing time is 1-24 hours.

[0231] The present invention's anti-peripheral leakage device can be used as a foam-based sealing device, a sealing cuff, or as a sealing skirt for an endovascular prosthesis, such as a transcatheter aortic valve implant. By improving the structure of the anti-peripheral leakage device, the present invention is more adaptable to invasive delivery while maintaining effective occlusion.

[0232] The present application also provides a paravalvular leakage prevention skirt with good sealing effect and delivery performance.

[0233] The paravalvular leakage prevention skirt comprises a flexible substrate in at least a portion thereof and a fabric-formed reinforcement component in at least a portion thereof, wherein the flexible substrate and the reinforcement component have an overlapping area.

[0234] Optionally, the anti-paravalvular leakage skirt includes:

[0235] Flexible substrate, using polyurethane film;

[0236] The reinforcing component is in the form of fabric, and at least a portion of the reinforcing component and at least a portion of the flexible substrate are overlapped and fixed to each other.

[0237] Optionally, at least a portion of the reinforcing component extends out of the flexible substrate.

[0238] Optionally, the anti-paravalvular leakage skirt further includes a sealing component fixed to the flexible substrate, and the sealing component adopts a deformable structure.

[0239] Optionally, the elongation at break of the flexible substrate is not less than 200%, and the tensile strength of the flexible substrate is 30-100 MPa.

[0240] Optionally, the blocking component is polyurethane with an open pore structure.

[0241] Optionally, the pores in the blocking component are interconnected and have uniform pore diameters.

[0242] Optionally, the porosity of the blocking component is 50-95%.

[0243] Optionally, the fabric is a flexible fabric, and the thickness of the fabric ranges from 0.04 mm to 0.2 mm.

[0244] Optionally, the raw material of the fabric is one of polyester (polyethylene terephthalate, PET), nylon (polyamide fiber, PA), and polyetheretherketone (PEEK).

[0245] Optionally, the fabric is a woven fabric with a weft knitted structure.

[0246] Optionally, the anti-paravalvular leakage skirt has an inflow end and an outflow end relative to each other according to the expected blood flow direction under a physiological environment, and the portion of the reinforcing component extending out of the flexible substrate is located at the outflow end.

[0247] Optionally, the blocking component is located at the inflow end of the anti-valvular leakage skirt.

[0248] Optionally, there is a distance between the blocking component and the reinforcing component in the axial direction of the anti-paravalvular leakage skirt.

[0249] Optionally, the distance between the blocking component and the reinforcing component is 3 mm to 20 mm.

[0250] Optionally, the blocking component and the reinforcing component are located on the same side of the flexible substrate, or the blocking component and the reinforcing component are located on different sides of the flexible substrate.

[0251] Optionally, the blocking component is raised relative to the flexible substrate.

[0252] Optionally, the flexible substrate has a first edge and a second edge opposite to each other, the first edge corresponding to the inflow end of the paravalvular leakage prevention skirt, the second edge being used for being fixed to the stent after being sutured with the valve leaflet, and the second edge being closer to the outflow end of the stent than the first edge;

[0253] The reinforcing component has a third edge and a fourth edge opposite to each other, and the fourth edge of the reinforcing component has the same shape as the second edge of the flexible substrate.

[0254] Optionally, the third edge and the fourth edge of the reinforcing component have the same shape, and the reinforcing component is substantially wavy and has the same width at all locations.

[0255] Optionally, the third edge of the reinforcing component is a smooth arc.

[0256] Optionally, the fourth edge of the reinforcing component is flush with the second edge of the flexible substrate.

[0257] Optionally, the flexible substrate has a first edge and a second edge opposite to each other, and the second edge is closer to the outflow end of the stent than the first edge;

[0258] The reinforcing component has a third edge and a fourth edge opposite to each other, and the fourth edge of the reinforcing component extends beyond the second edge of the flexible substrate to form an extension for sewing.

[0259] Optionally, the blocking component is at least one protrusion fixed on the flexible substrate.

[0260] Optionally, the reinforcing component and the flexible substrate are connected by at least one of solvent bonding, solution bonding, hot melt bonding, and sewing and splicing.

[0261] Optionally, the solvent used in the solvent bonding is at least one of dimethyl sulfoxide (DMSO), N,N-dimethylformamide (DMF), and N,N-dimethylacetamide (DMAC).

[0262] Optionally, the solution used for solution bonding is a polyurethane solution, the concentration of the polyurethane solution is 5-20 wt%, and the solvent of the polyurethane solution is at least one of dimethyl sulfoxide (DMSO), N,N-dimethylformamide (DMF), and N,N-dimethylacetamide (DMAC).

[0263] Optionally, when a solution or solvent is used for bonding, after the joint is completely soaked by the solvent or solution, it is dried at a temperature of 50 to 70 degrees.

[0264] Optionally, the temperature of the hot melt bonding is 50-70°C, and the heating time is 0.5-2 hours.

[0265] Optionally, the blocking component and the flexible substrate are connected via a bonding area, and the bonding area is formed by contact, penetration, and solidification of the flexible substrate and the adjacent portion of the protrusion in the form of a solution.

[0266] Optionally, the thickness T1 of the flexible substrate is 0.03mm-0.05mm, the thickness T2 of the reinforcing component is 0.04-0.2mm, the thickness T3 of the overlapping and fixed portion of the flexible substrate and the reinforcing portion is 0.05-0.24mm, and T1, T2, and T3 satisfy the constraint: 0.05mm≥T1+T2-T3≥0.01mm.

[0267] The present application also provides a method for preparing an anti-paravalvular leakage skirt, comprising:

[0268] connecting the reinforcing component and the blocking component on the flexible substrate respectively;

[0269] Cut the reinforcement and the flexible substrate to the desired shape.

[0270] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0271] Optionally, the reinforcing component and the blocking component are connected to the flexible substrate in any of the following order:

[0272] a) sequentially connecting a reinforcing component and a blocking component on a flexible substrate;

[0273] b) sequentially connecting the blocking component and the reinforcing component on the flexible substrate.

[0274] Optionally, the reinforcing component and the flexible substrate are cut into desired shapes in any of the following orders:

[0275] 1) Before connecting the reinforcing component to the flexible substrate, the flexible substrate and the reinforcing component are cut separately;

[0276] 2) After the reinforcing component is connected to the flexible substrate, the flexible substrate and the reinforcing component are cut at the same time.

[0277] Optionally, the preparation of the blocking component includes:

[0278] The polyurethane solution is mixed with solid particles to obtain a premix;

[0279] The premix is ​​solidified and washed to obtain a plugging component containing a pore structure.

[0280] Optionally, the particle size of the solid particles is 80-120 mesh.

[0281] The present application also provides an artificial implant, comprising:

[0282] The stent is a deformable tubular structure with a hollow area on the side wall, and the interior of the stent is a blood flow channel;

[0283] a valve leaflet connected to the stent to control the blood flow channel;

[0284] The anti-paravalvular leakage skirt is located inside the stent as a whole, the outflow end of the anti-paravalvular leakage skirt is docked with the leaflet, and the blocking component protrudes from the stent through the hollow area of ​​the stent.

[0285] Optionally, the blocking component is located at the inflow end of the stent, and the axial height of the blocking component corresponds to 1 to 2 rows of cells at the inflow end of the stent.

[0286] The present application also provides a method for preparing an artificial implant, comprising:

[0287] A prefabricated product is formed by connecting the valve leaflets and the paravalvular leakage prevention skirt to each other and forming a cylindrical shape;

[0288] The preform is assembled to the support.

[0289] The anti-paravalvular leakage skirt provided by the present application has at least one of the following beneficial effects:

[0290] a) The anti-paravalvular leakage skirt uses a polyurethane film as a flexible substrate, and is reinforced with a fabric-like reinforcing component on the flexible substrate. Compared with porcine pericardium, the polyurethane film is thinner, more flexible, and has easier-to-control properties. The reinforcing component improves the sewing performance of the flexible substrate. Specifically, the reinforcing component withstands the suture pulling force in the area requiring sewing, compensating for the insufficient strength of the flexible substrate itself. This improves the sewing strength and also extends the service life of the skirt.

[0291] b) The reinforcing component is overlapped and fixed to the flexible substrate, and at least a portion thereof extends beyond the edge of the flexible substrate to serve as an extension portion for passing the suture. The extension portion only has the reinforcing component and no flexible substrate, thereby ensuring sewing strength while reducing the transport size;

[0292] c) A polyurethane occlusion component with an open pore structure is used as the occlusion component. The occlusion component has excellent compression and rebound properties. Its volume in the compressed state can be 10% of its natural volume. During delivery, it can be compressed to a smaller radial dimension. After being released to the implantation site, the pressure is unloaded and it expands spontaneously under physiological conditions through the capillary action of the pore structure. Based on the open pore structure, the height and shape can be adaptively adjusted according to the complex physiological environment, achieving active seamless occlusion. At the same time, this material has good biocompatibility and is non-thrombogenic, which can achieve an ideal anti-paravalvular leakage effect. At the same time, the occlusion component is smaller than the stent in terms of axial length, which does not increase the size of the delivery period.

[0293] d) The connection between the flexible substrate and the reinforcing component can be achieved by solvent bonding, solution bonding, hot melt bonding, etc. On the one hand, the thickness of the overlapping parts can be reduced. On the other hand, since the solvent, solution or melted flexible substrate can penetrate into the gaps between the fabrics of the reinforcing component, the strength of the connection can be increased, making it difficult for the two to be separated;

[0294] e) The sealing component and the flexible substrate are made of the same polyurethane. Since the two are made of the same material, a bonding area is formed by melting, penetrating and solidifying the contact parts of the two, which has better bonding strength at the interface and is not easy to separate.

[0295] The present application also provides an adaptive anti-paravalvular leakage material that can achieve a good blocking effect without increasing the size of the delivery device access path.

[0296] The present application discloses an adaptive anti-paravalvular leakage material, which includes: a sheet-shaped and stretchable flexible substrate, and a sealing component attached to the flexible substrate. The sealing component is one or more protrusions, each of which has a pore structure. The flexible substrate and the protrusions are both made of polyurethane, and the connection between the flexible substrate and the protrusions is achieved by curing a polyurethane solution.

[0297] Optionally, the elongation at break of the flexible substrate is not less than 200%.

[0298] Optionally, the elongation at break of the flexible substrate is not less than 300%.

[0299] Optionally, the elongation at break of the flexible substrate is 200% to 500%.

[0300] The pore size of the raised portion is 5 to 500 microns. Preferably, the pore size of the raised portion is 5 to 450 microns. Preferably, the pore size of the raised portion is 5 to 400 microns. Preferably, the pore size of the raised portion is 5 to 350 microns. Preferably, the pore size of the raised portion is 5 to 300 microns. Preferably, the pore size of the raised portion is 5 to 250 microns.

[0301] The porosity of the protrusion is 50-95%. Preferably, the porosity of the protrusion is 60-95%. Preferably, the porosity of the protrusion is 70-90%.

[0302] The protrusion has an open pore structure and / or a closed pore structure. Preferably, the protrusion has an open pore structure.

[0303] The average thickness of the flexible substrate is 0.02 to 0.20 mm. Preferably, the average thickness of the flexible substrate is 0.02 to 0.15 mm. Preferably, the average thickness of the flexible substrate is 0.02 to 0.12 mm.

[0304] The tensile strength of the flexible substrate is 30 to 100 MPa. Preferably, the tensile strength of the flexible substrate is 40 to 100 MPa. Preferably, the tensile strength of the flexible substrate is 50 to 100 MPa. Preferably, the tensile strength of the flexible substrate is 50 to 90 MPa. Preferably, the tensile strength of the flexible substrate is 50 to 80 MPa.

[0305] The present application also provides an adaptive anti-paravalvular leakage material, which includes: a sheet-shaped and stretchable flexible substrate, and one or more protrusions attached to the flexible substrate, each protrusion having a pore structure, and the flexible substrate and the protrusions are both made of polyurethane material. The flexible substrate and the protrusions are connected by a bonding area, and the bonding area is formed by the contact, penetration, and solidification of the adjacent parts of the flexible substrate and the protrusions in the form of a solution.

[0306] The present application also provides an adaptive anti-paravalvular leakage material, which is made of polyurethane. The anti-paravalvular leakage material includes: a sheet-shaped and stretchable flexible substrate, and one or more protrusions connected to the flexible substrate. The flexible substrate and the protrusions are both molded using a casting process. The casting liquid of the protrusions is a polyurethane solution containing solid particles, and the casting liquid of the flexible substrate is a polyurethane solution or a polyurethane mixture containing solid particles.

[0307] The present application also provides an adaptive anti-paravalvular leakage material, which includes a flexible substrate and a protrusion. The porosity of the protrusion is not lower than that of the flexible substrate. The interface between the flexible substrate and the protrusion is formed by contact, penetration and solidification of the adjacent parts of the flexible substrate and the protrusion in the form of a solution.

[0308] Optionally, the protrusion and the flexible substrate are made of the same material.

[0309] Optionally, the protrusion and the flexible substrate are both made of polyurethane.

[0310] Optionally, both the protrusion and the flexible substrate are porous structures, and the porosity of the protrusion is not lower than that of the flexible substrate.

[0311] Optionally, the protrusion has a porous structure, and the flexible substrate has a dense structure without pores.

[0312] The present application also provides a method for preparing an adaptive anti-paravalvular leakage material, comprising the following steps performed in any order:

[0313] Filling a mold with a polyurethane mixture containing solid particles, and washing and removing the solid particles after curing to obtain a protrusion;

[0314] The flexible substrate is obtained by curing a polyurethane solution, or by curing and washing a polyurethane mixture containing solid particles. The connection between the flexible substrate and the protrusion is achieved by curing the polyurethane solution.

[0315] Optionally, the polyurethane molecular chain includes a hard segment and a soft segment, wherein the soft segment content is 40 to 70%, and the rest is a hard segment, the soft segment is at least one of polyether diol, polycarbonate diol, polyester diol, and polysiloxane diol, and the hard segment is isocyanate, and the R value of the isocyanate is 1.0 to 1.1.

[0316] Optionally, the soft segment content in the polyurethane molecular chain is 50%-65%.

[0317] Optionally, the isocyanate is at least one of TDI, HDI, MDI, NDI, PPDI, IPDI, and XDI.

[0318] Optionally, the polyurethane molecular chain further includes a chain extender (the chain extender belongs to the hard segment), and the chain extender is at least one of ethylene glycol, butanediol, hexanediol, octanediol, and ethylenediamine.

[0319] Optionally, the solvent of the polyurethane solution is at least one of dimethyl sulfoxide (DMSO), tetrahydrofuran (THF), dimethylformamide (DMF), dimethylacetamide (DMAc), dichloromethane, chloroform, and hexafluoroisopropanol (HFIP).

[0320] Optionally, the solvent of the polyurethane solution is two of dimethyl sulfoxide (DMSO), tetrahydrofuran (THF), dimethylformamide (DMF), dimethylacetamide (DMAc), dichloromethane, chloroform, and hexafluoroisopropanol (HFIP), and the volume ratio of the two solvents is 1 to 99:1. The volume ratio of the two solvents is 5 to 95:1. The volume ratio of the two solvents is 10 to 95:1. The volume ratio of the two solvents is 15 to 95:1. The volume ratio of the two solvents is 20 to 95:1. The volume ratio of the two solvents is 25 to 95:1. The volume ratio of the two solvents is 10 to 90:1. The volume ratio of the two solvents is 10 to 80:1. The volume ratio of the two solvents is 15 to 75:1. The volume ratio of the two solvents is 20 to 75:1. The volume ratio of the two solvents is 25 to 75:1.

[0321] Optionally, the concentration of polyurethane in the polyurethane solution is 0.25% to 25% (w / v). Preferably, the concentration of polyurethane is 0.5% to 20% (w / v). Preferably, the concentration of polyurethane is 0.5% to 15% (w / v). Preferably, the concentration of polyurethane is 0.5% to 10% (w / v). Preferably, the concentration of polyurethane is 5% to 25% (w / v). Preferably, the concentration of polyurethane is 1% to 25% (w / v). Preferably, the concentration of polyurethane is 2% to 25% (w / v). Preferably, the concentration of polyurethane is 3% to 25% (w / v). Preferably, the concentration of polyurethane is 4% to 25% (w / v). Preferably, the concentration of polyurethane is 5% to 20% (w / v). Preferably, the concentration of polyurethane is 5% to 15% (w / v). Preferably, the concentration of polyurethane is 8% to 20% (w / v). Preferably, the concentration of polyurethane is 10% to 20% (w / v).

[0322] Optionally, the solid particles are at least one of sodium chloride, potassium chloride, and sucrose.

[0323] Optionally, the number average particle size of the solid particles is 5 to 500 microns. Preferably, the number average particle size of the solid particles is 5 to 450 microns. Preferably, the number average particle size of the solid particles is 5 to 400 microns. Preferably, the number average particle size of the solid particles is 5 to 350 microns. Preferably, the number average particle size of the solid particles is 5 to 300 microns. Preferably, the number average particle size of the solid particles is 5 to 250 microns.

[0324] Optionally, in the polyurethane mixture containing solid particles, the mass fraction of the solid particles is 50% to 80%. Preferably, the mass fraction of the solid particles is 55% to 80%. Preferably, the mass fraction of the solid particles is 60% to 80%. Preferably, the mass fraction of the solid particles is 60% to 75%.

[0325] Optionally, the mold includes a plurality of mold cavities, each mold cavity corresponds to a protrusion, and the distribution of the mold cavities is consistent with the distribution of the protrusions.

[0326] Optionally, the curing temperature of the protrusion and the flexible substrate is 20 to 90°C. Preferably, the curing temperature of the protrusion and the flexible substrate is 20 to 70°C. Preferably, the curing temperature of the protrusion and the flexible substrate is 20 to 50°C.

[0327] Optionally, the protrusions and the flexible substrate may be subjected to post-treatment after curing, wherein the post-treatment comprises placing the protrusions and the flexible substrate in 20-40°C water for at least 1 hour.

[0328] Optionally, the post-processing includes: placing the protrusion and the flexible substrate in 20-40°C water for 2-4 hours.

[0329] Optionally, the preparation of the protrusions and the flexible substrate further includes pre-curing before the curing step, and the pre-curing conditions are: pre-curing temperature 20-70°C, and pre-curing time 20-60 minutes.

[0330] Optionally, the pre-curing conditions are: pre-curing temperature 30-60°C, pre-curing time 20-40 minutes.

[0331] Optionally, washing the raised portion and the flexible substrate comprises placing the raised portion in a detergent and allowing it to stand for at least 4 hours.

[0332] Optionally, washing the protrusions and the flexible substrate includes placing the protrusions in a detergent and leaving them to stand for 4 to 12 hours.

[0333] Optionally, washing the protrusions and the flexible substrate comprises: treating the protrusions in a detergent in an agitated state for at least 4 hours.

[0334] Optionally, washing the protrusions and the flexible substrate includes placing the protrusions in a detergent in an agitated state for 4 to 12 hours.

[0335] The polyurethane solution in contact with the protrusion is at room temperature or has been preheated, and the preheating temperature of the polyurethane solution is 30 to 70°C. Preferably, the preheating temperature of the polyurethane solution is 40 to 70°C. Preferably, the preheating temperature of the polyurethane solution is 50 to 70°C.

[0336] Optionally, the preparation of the protrusion and the flexible substrate further includes preliminary curing before the pre-curing step. The preliminary curing can be performed in one of the following ways:

[0337] a) Blowing hot air on the surface of the polyurethane mixture containing solid particles;

[0338] b) spraying hot steam on the surface of the polyurethane mixture containing solid particles;

[0339] c) adding water, ethanol or isopropyl alcohol dropwise to the polyurethane mixture containing solid particles;

[0340] In step a), the hot air temperature is 40-100°C, and the purge time is 0.5-2 min.

[0341] In step b), the steam temperature is 40-100°C, and the spraying time is 0.5-2 min.

[0342] In step c), 1 to 2.5 mL is added dropwise.

[0343] The present application also provides an artificial heart valve, comprising:

[0344] The stent has a blood flow channel inside, and the stent has an inflow side and an outflow side opposite to each other, and the inflow side has a grid structure;

[0345] One or more leaflets;

[0346] The anti-valvular leakage material is connected to the inflow side, the flexible substrate of the anti-valvular leakage material is located inside the stent, and the protrusion is embedded in the grid structure; or the flexible substrate of the anti-valvular leakage material is located outside the stent, and the protrusion is located on the side of the flexible substrate away from the stent.

[0347] In combination with the above, the raised portion serves as a sealing block or a sealing component to reduce peripheral leakage. When the flexible substrate is located inside the bracket, it serves as an inner skirt. When the flexible substrate is located outside the bracket, it can serve as an outer skirt. The outer skirt and the sealing block constitute an anti-peripheral leakage structure. Beneficial effects

[0348] The adaptive anti-paravalvular leakage material provided in this application can achieve a good sealing effect without increasing the size of the delivery device access path, and has good adaptability. It can effectively prevent the valve skirt from folding, uneven force, and large friction with the delivery system during the valve pressing and loading process. BRIEF DESCRIPTION OF THE DRAWINGS

[0349] FIG1 is a schematic diagram of an artificial implant provided by the present application;

[0350] FIG2 is a schematic structural diagram of an artificial implant according to an embodiment of the present application;

[0351] FIG3 is a schematic diagram of the structure of FIG2 in which the bracket is omitted;

[0352] FIG4 is a schematic structural diagram of an artificial implant in one embodiment of the present application;

[0353] 5 to 7 are schematic diagrams of a blocking assembly protruding from a stent in some embodiments of the present application;

[0354] 8 to 8a are schematic structural diagrams of the arrangement of blocking components in some embodiments of the present application;

[0355] 9 to 11 are schematic diagrams of partial structures of outer skirt covering grids in some embodiments of the present application;

[0356] 11a to 11c are schematic diagrams of the bag structure between the outer skirt and the inner skirt in some embodiments of the present application;

[0357] FIG12 is a schematic diagram of FIG9 with the inner skirt, outer skirt and multiple leaflets flattened;

[0358] FIG13 is a schematic diagram of the first sheet and the second sheet in FIG12 as an integrated structure;

[0359] 14 to 17 are schematic structural diagrams of the inner skirt and outer skirt configurations in some embodiments of the present application;

[0360] FIG17a is a schematic structural diagram of a blocking component located outside an outer skirt in some embodiments of the present application;

[0361] FIG18 is a schematic structural diagram of a skirt with a serrated inflow edge in one embodiment of the present application;

[0362] 19 to 21 are schematic diagrams of the structure of the sealing assembly as a ring member in some embodiments of the present application;

[0363] FIG22 is a cross-sectional view of the annular member in FIG19 along the radial direction;

[0364] FIG22a is a schematic diagram of the structure of the spacing distribution of blocking blocks in some embodiments of the present application;

[0365] FIG22 b is a schematic diagram of the structure of continuous distribution of blocking blocks in some embodiments of the present application;

[0366] 23 to 25 are schematic diagrams of the blocking block along the radial perspective of the stent in some embodiments of the present application;

[0367] FIG25 a is a schematic diagram of the arrangement of blocking blocks with their wide sides facing each other in some embodiments of the present application;

[0368] 26 to 27a are cross-sectional views of blocking blocks in some embodiments of the present application;

[0369] 28 to 30 are schematic diagrams of the installation position of the blocking assembly in this application;

[0370] FIG31 is a schematic diagram of the winding arrangement of sutures and reinforcement members in one embodiment of the present application;

[0371] FIG31 a is a schematic diagram of a local growth of an inner skirt in one embodiment of the present application;

[0372] FIG32 is a schematic diagram of the reinforcement line extending along the circumferential direction of the stent in FIG31;

[0373] FIG33a is a schematic diagram of the structure of the overall reinforcement of the inner skirt in one embodiment of the present application;

[0374] FIG33 b is a schematic diagram of the structure of the local reinforcement of the inner skirt in one embodiment of the present application;

[0375] FIG33c is a schematic diagram of the structure of the inner and outer skirts and the reinforced sealing components in one embodiment of the present application;

[0376] Figure 33d is a schematic diagram of the structure in which the inner and outer skirts are integrated and reinforced;

[0377] FIG34a is a schematic diagram of the structure after the inner and outer skirts are integrally mounted (the reinforcement assembly is located on the outside of the outer skirt); FIG34b is a schematic diagram of the structure after the inner and outer skirts are integrally mounted (the reinforcement assembly is located on the inner and outer sides of the outer skirt); FIG34 is a schematic diagram of the structure of the reinforcement of the integrally structured skirt in one embodiment of the present application;

[0378] 35 to 37 are schematic diagrams of locally enhanced skirts in some embodiments of the present application;

[0379] 38 to 41 are schematic diagrams showing the distribution of development marks in this application;

[0380] Figures 42a to 42c are schematic diagrams of the peeling test process;

[0381] FIG43 is a schematic diagram of an artificial implant after release in vivo;

[0382] FIG44 is a schematic diagram of the structure of the anti-peripheral leakage device embedded in an artificial implant in this application;

[0383] FIG45 is a schematic structural diagram of the anti-circular leakage device in FIG44;

[0384] FIG46 is a cross-sectional view taken along the AA direction in FIG44;

[0385] FIG47 is a partial enlarged view of point B in FIG46;

[0386] FIG48 is a schematic diagram of adjacent ring blocking blocks interlaced with each other in the present application;

[0387] FIG49 is a schematic structural diagram of the anti-circular leakage device in FIG48 in a straightened state;

[0388] FIG50 is a partial enlarged view of point C in FIG48;

[0389] FIG51 is a partial cross-sectional view taken along the HH direction in FIG50;

[0390] FIG52 is a schematic diagram of the structure of the closed grid in FIG50;

[0391] FIG53 is a schematic diagram of the structure of the open grid in FIG50;

[0392] FIG54 is a schematic structural diagram of a blocking block filled with a closed grid in FIG50;

[0393] FIG55 is a schematic diagram of the structure of the blocking block filled with the open grid in FIG50;

[0394] FIG56 is a schematic structural diagram of the anti-circular leakage device of FIG48 from another perspective;

[0395] FIG57 is a partial enlarged view of point D in FIG56;

[0396] FIG58 is a schematic diagram of the anti-circular leakage device in FIG56 in a straightened state;

[0397] FIG59 is a schematic diagram of the staggered arrangement of the pull wires of the anti-peripheral leakage device;

[0398] FIG60 is a schematic diagram of the circuitous arrangement of the pull wires of the anti-peripheral leakage device;

[0399] FIG61 is a schematic diagram of a circle arrangement of blocking blocks in the peripheral leakage prevention device of the present application;

[0400] FIG62 is a schematic diagram of the sealing blocks arranged in two circles in the peripheral leakage prevention device of the present application;

[0401] FIG63 is a schematic diagram of the connection between the blocking block and the pull wire in FIG62;

[0402] FIG64 is a schematic diagram of a sealing block embedded with a wire knot in the peripheral leakage prevention device of the present application;

[0403] FIG65 is a schematic diagram of a peripheral leakage prevention device with an inner lining membrane according to the present application;

[0404] FIG66 is a cross-sectional view taken along the FF direction in FIG65;

[0405] FIG67 is a schematic diagram of an artificial implant provided by the present application;

[0406] FIG68 is a schematic diagram of the artificial implant of FIG67 after being released in vivo;

[0407] FIG69 is a flow chart of a method for processing an artificial implant provided by the present application;

[0408] FIG70 is a schematic diagram of step A2 in a method for processing an artificial implant provided by the present application;

[0409] FIG71 is a schematic diagram of step A3 in a method for processing an artificial implant provided by the present application;

[0410] FIG72 is a flow chart of another method for processing an artificial implant provided by the present application;

[0411] FIG73 is a schematic diagram of step B1 in another method for processing an artificial implant provided by the present application;

[0412] FIG74 is a schematic diagram of step B2 in another method for processing an artificial implant provided by the present application;

[0413] FIG75 is a schematic structural diagram of a molding die for a peripheral leakage prevention device provided in the present application;

[0414] FIG76 is a partial cross-sectional view taken along the GG direction in FIG75 ;

[0415] FIG77 is a schematic structural diagram of a split-type anti-circular leakage device forming mold provided by the present application;

[0416] FIG78 is a schematic structural diagram of the mold for forming the integrated anti-circumferential leakage device provided in this application.

[0417] FIG79 is a flow chart of a method for forming an anti-circular leakage device using a mold provided by the present application;

[0418] FIG80 is a schematic structural diagram of a peripheral leakage prevention device according to another embodiment of the present application;

[0419] FIG81 is a schematic diagram of the structure of the anti-circular leakage device embedded in the bracket of FIG80;

[0420] FIG82 is a schematic diagram of a flexible substrate in one embodiment of the anti-paravalvular leakage skirt of the present application;

[0421] FIG83 is a schematic diagram of a reinforcing component in one embodiment of the anti-paravalvular leakage skirt of the present application;

[0422] FIG84 is a schematic diagram of the structures shown in FIG82 and FIG83 after connection;

[0423] FIG85 is a schematic diagram of a flexible substrate in one embodiment of the anti-paravalvular leakage skirt of the present application;

[0424] FIG86 is a schematic diagram of a reinforcing component in one embodiment of the anti-paravalvular leakage skirt of the present application;

[0425] FIG87 is a schematic diagram of the structures shown in FIG85 and FIG86 after connection;

[0426] FIG88 is a schematic diagram of the structure shown in FIG84 after connecting the blocking assembly;

[0427] FIG89 is a schematic diagram of the structure shown in FIG87 after connecting the blocking assembly;

[0428] FIG90 is a schematic diagram of a reinforcing component in one embodiment of the anti-paravalvular leakage skirt of the present application;

[0429] FIG91 is a schematic diagram of one embodiment of the anti-paravalvular leakage skirt of the present application (omitting the blocking component); FIG92 is a schematic diagram of the anti-paravalvular leakage material prepared in Comparative Example 1;

[0430] FIG93 is a schematic diagram of an anti-paravalvular leakage material prepared according to Example 1 of the adaptive anti-paravalvular leakage material of the present application;

[0431] FIG94 is a schematic diagram of the anti-paravalvular leakage material prepared in Comparative Example 1 (the lower half is a partial enlargement);

[0432] FIG95 is a schematic diagram of the anti-paravalvular leakage material prepared in Example 7 (the lower half is a partial enlargement);

[0433] FIG96 is a flow chart of preparing an anti-paravalvular leakage material according to Example 7;

[0434] FIG97 is a microscopic image of the anti-paravalvular leakage material prepared in Example 7;

[0435] FIG98 is a schematic diagram of the bonding area of ​​the anti-paravalvular leakage material;

[0436] Figure 99 is a schematic diagram of the mold.

[0437] The reference numerals in the figures are described as follows:

[0438] 1. Stent; 11. Stent grid; 111. Open grid; 112. Closed grid; 112a. Closed grid; 112b. Closed grid; 12. Frame; 121. Grid node; 13. Blood flow channel; 131. Inflow side; 132. Outflow side; 14. Foot; 15. Waist region; 16. Artificial implant; 161. Grid structure; 161a. Grid structure; 1611. Closed grid; 1612. Open grid; 1613. Middle region; 1614. Edge region; 162. Stent; 1621. Inflow side; 1622. Outflow side; 1623. Blood flow channel; 165. Leaflet;

[0439] 2. Anti-leakage device; 2a. Inside; 2b. Outside; 21. Blocking block; 211. Blocking block; 211a. Blocking block; 211b. Blocking block; 212. Blocking block; 212a. Blocking block; 212b. Blocking block; 22. Pulling wire; 22a. Pulling wire; 22b. Pulling wire; 22c. Pulling wire; 22d. Pulling wire; 22e. Pulling wire; 221. Knot; 222. Circuitous structure; 23. Connecting strip; 24. Blocking block ring; 24a. Blocking block ring; 24b. Blocking block ring; 241. Spacing portion; 25. Blocking block ring; 26. Lining membrane; 27. Blocking block net; 28. Blocking block strip;

[0440] 3. Skirt; 31. Inner skirt; 311. Inflow edge; 312. Outflow edge; 313. Tubular structure; 32. Outer skirt; 321. Tubular structure; 322. Outflow edge; 323. Inflow edge; 33. Accommodation area; 33a. Pouch structure; 331. Opening;

[0441] 4. Blocking assembly; 41a. Blocking assembly; 41b. Blocking assembly; 42. Ring member; 43. Blocking block; 43a. Blocking block; 431. Wide side; 432. Narrow side; 433. Inner side; 434. Outer side; 44. Spacer; 45. Peak; 46. Valley; 47. Connecting area; 48. Embedding area;

[0442] 5. First sheet; 51. Second sheet;

[0443] 6. Reinforcement member; 61. Reinforcement fabric; 62. Stitching thread; 63. Developing mark; 63a. Developing mark; 63b. Developing mark; 63c. Developing mark; 63d. Developing mark; 631. First mark; 632. Second mark; 64. Reinforcement thread; 64a. Reinforcement thread; 64b. Reinforcement thread; 64c. Reinforcement thread; 65. Reinforcement gasket;

[0444] 7. Leaflet; 71. Fixed edge; 72. Free edge; 73. Joint;

[0445] 8. Mold; 81. Main body; 811. Working surface; 82. Mold cavity; 83. Wire groove; 84. Forming frame; 841. Hollow area; 842. Sinking area;

[0446] 90. Paravalvular leakage prevention skirt; 91. Occlusion component; 92. Flexible substrate; 921. First edge; 922. Second edge; 93. Mold; 9. Mold cavity; 95. Reinforcement component; 951. Third edge; 952. Fourth edge; 953. Extension;

[0447] 100, PET film; 200, PU film; 300, interlayer. Modes for Carrying Out the Invention

[0448] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0449] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0450] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0451] Referring to Figures 1 to 6 , to enhance the skirt's ability to prevent circumferential leakage and provide adaptive adjustment capabilities, one embodiment of the present application provides an artificial implant that can be delivered to a lesion within the body via surgical or transcatheter intervention. During transcatheter intervention, the artificial implant can be loaded onto the distal end of a catheter assembly and delivered and installed within the body via manipulation of a control handle. The artificial implant described below uses an artificial heart valve as an example. Once installed within the body, it can replace the original diseased valve and restore normal valve function, achieving a therapeutic effect.

[0452] An embodiment of the present application provides an artificial implant, comprising:

[0453] The stent 1 is a radially deformable cylindrical structure having a through blood flow channel 13;

[0454] Multiple leaflets 7, each leaflet having a fixed edge 71 and a free edge 72 opposite to each other, wherein the fixed edge is fixed to the stent, and the free edge is used to control the blood flow channel 13;

[0455] The anti-circumferential leakage structure is arranged along the circumference of the bracket. The anti-circumferential leakage structure is:

[0456] At least a portion of the blocking component radially protrudes outward from the stent and the blocking component adopts a deformable structure; and / or

[0457] An outer skirt wrapped around the outer periphery of the bracket.

[0458] Among them, the bracket 1 has a corresponding axial direction (axial direction), a radial direction perpendicular to the axial direction, and a circumferential direction arranged around the axis. The bracket 1 is provided with a bracket grid 11, which can be understood as a cylindrical structure with a hollow area on the side wall. The edge of the hollow area is the frame bar 12 that surrounds the bracket grid. The intersection position of adjacent frame bars 12 is the grid node 121. There is no strict limitation on the size and specific shape of the bracket grid. It can be a conventional rhombus, fishbone shape, hexagon, etc. The bracket can be loaded in the interventional delivery system through radial compression, and the grid and frame bars will also be deformed accordingly during the radial compression process. In the axial direction of the stent (as shown in the X direction in Figure 1), the stent 1 is provided with a multi-layer stent grid 11, which is an inflow side 131 and an outflow side 132 according to the normal blood flow direction in the body. The grids of adjacent layers are staggered, as shown in Figure 8. The stent grid on the inflow side of the stent includes an open grid 111 and a closed grid 112. The stent itself can be cut or woven from a tube. Depending on the release method in the body, a memory material (such as nickel-titanium alloy, etc.) that adapts to self-expansion release or a stainless steel material that adapts to ball expansion release can be used.

[0459] The stent 1 has a continuous blood flow channel 13 inside. The fixed edge 71 of each leaflet 7 is sutured and fixed to the stent 1. The free edges 72 of the multiple leaflets fit together to close the blood flow channel 13. The multiple leaflets can be made of biological materials or synthetic materials. The anti-peripheral leakage structure has various structural forms, specifically divided into:

[0460] In the first case, for example, the anti-circumferential leakage structure shown in FIG2 is an outer skirt wrapped around the outer periphery of the stent (excluding the sealing component);

[0461] In the second case, for example, the anti-circumferential leakage structure shown in FIG8 is a blocking component that radially protrudes outward from the stent (excluding the outer skirt);

[0462] In the third case, as shown in FIG4 , the leakage prevention structure includes both the outer skirt and the blocking component.

[0463] The following embodiments will further illustrate these three situations.

[0464] In some embodiments, the artificial implant may further include a skirt 3, the skirt 3 including an inner skirt 31 located radially inside the stent and / or an outer skirt 32 located radially outside the stent; the skirts are divided based on the radial position relative to the stent, the one located radially inside the stent is called the inner skirt, and the one located radially outside the stent is called the outer skirt. The artificial implant may have only an inner skirt or an outer skirt, or two skirts (an inner skirt and an outer skirt). As shown in Figures 3 to 4, the artificial implant has two skirts. The inner skirt 31 is sutured and spliced ​​with the fixed edges 71 of multiple leaflets. After processing is completed, the inner skirt 31 and the outer skirt 32 respectively form a cylindrical structure 313 and a cylindrical structure 321 that are compatible with the stent.

[0465] A accommodating area 33 arranged along the circumference of the stent is formed between the cylindrical structure 313 and the cylindrical structure 321, which is the radial gap between the two skirts, and a part of the stent is also in the accommodating area 33. The components such as the skirts, the sealing assembly and the stent can be connected by suturing, bonding or configuring other connectors according to the properties of the materials. In some embodiments, the outer skirt itself has elasticity and can be tightened around the periphery of the stent according to this feature. When combined with the sealing assembly, it can be fully or partially wrapped on the outside. When only a part is wrapped, the outflow edge of the outer skirt is just tightened around the periphery of the sealing assembly. In some embodiments, the periphery of the sealing assembly has convex and concave (radially) undulating parts, and the outflow edge of the outer skirt can correspond to the relative convex parts on the sealing assembly, or can correspond to the relative concave parts on the sealing assembly. The following is a further description in conjunction with the accompanying drawings.

[0466] The blocking component 4 adopts a deformable structure and is arranged along the circumference of the stent. At least a portion of the blocking component 4 radially protrudes outward from the stent 1. The "protrusion" here can be understood in many ways. It can be understood that, from the cross-section of the position where the blocking piece is located, only a portion of the blocking component protrudes outward from the stent and the entire component is within the accommodating area of ​​the two skirts (as shown in Figure 5), or it can be understood that the entire blocking component is located outside the stent and the entire component is still within the accommodating area of ​​the two skirts (as shown in Figure 6), or it can be understood that the entire blocking component is located outside the stent and the entire component is outside the accommodating area of ​​the two skirts (as shown in Figure 7). In all three cases, the blocking component protrudes outward from the stent, so that after the blocking component absorbs blood and deforms (i.e., self-expands), it can perfectly fit the valve annulus and achieve the function of preventing paravalvular leakage.

[0467] There are many ways to connect the plugging assembly to the two skirts, and only a few of them are listed below.

[0468] First, the blocking component is bonded to at least one of the inner skirt and the outer skirt;

[0469] Secondly, the blocking component and at least one of the inner skirt and the outer skirt are an integral structure, which not only omits the process of bonding the blocking component and the skirt, but also enhances the connection strength between the two.

[0470] Secondly, the blocking component 4 is an independent structure, which is wrapped in the radial gap between the two skirts, that is, the accommodating area 33, and is not directly connected to the two skirts.

[0471] The connection method between the above-mentioned blocking component and the two skirts can both enable the inflow end of the stent to form a self-expanding effect, play a role of adaptive blocking, and reduce paravalvular leakage.

[0472] Some embodiments of the present application further provide an artificial implant comprising a stent 1, a plurality of leaflets 7, a skirt 3, and a blocking assembly 4, which can be combined with the above embodiments. The skirt comprises an inner skirt 31 located on the inner side of the stent, and the blocking assembly is continuously distributed along the circumference and disposed around the outer periphery of the stent. The blocking assembly is secured to the inner skirt via a hollowed-out portion of the stent grid and wraps around at least a portion of the bars that constitute the stent grid.

[0473] Referring to Figure 8a, the stent 1 is only connected to an inner skirt 31 located on the radial inner side of the stent. The blocking component is annular as a whole, and is looped around the inflow side of the stent from the outside of the stent. The blocking component 4 includes an embedding area 48 and a connection area 47 connecting the embedding areas. A part of the blocking component, namely the embedding area 48, can be embedded in the hollow part of the stent grid 11 and can be fixed to the inner skirt by bonding or sewing. The connection area 47 of the blocking component wraps at least a part of the frame bar 12 that constitutes the stent grid.

[0474] Preferably, the edge of the connection area 47 may be configured to have a sawtooth shape that matches the stent grid, so as to avoid multi-layer stacking of the connection area when the stent is compressed, thereby affecting the radial size after compression.

[0475] In other embodiments, the skirt includes an inner skirt 31 on the inner side of the bracket and an outer skirt 32 on the outer side of the bracket. The outer skirt 32 is arranged on the inflow side 131, and the axial span of the outer skirt is 0.5 to 2 grids (with a closed grid as a reference). As a whole, the outer skirt covers 0.5 to 2 layers of grids in the circumferential direction. For example, in Figures 9 and 10, the outer skirt only covers one closed grid 112 in the axial direction (that is, it covers one layer of closed grid in the circumferential direction), but also covers the open grid 111 at the same time. Correspondingly, the blocking component 4 can be only provided on one layer of closed grid (as shown in Figure 10). 10 ), or simultaneously arranged in two adjacent layers of closed grids (such as the blocking components 41a and 41c in FIG10 ), or simultaneously arranged in closed grids and open grids (such as the blocking components 41a and 41b in FIG9 ); for another example, the outer skirt in FIG11 only covers 0.5 closed grids, but also covers adjacent open grids. Correspondingly, the blocking component 4 can be arranged only in the open grid 111, or in both the closed grid 112 and the open grid 111 (such as the blocking components 41a and 41b in FIG11 ). The outer skirt covers two layers of closed grids or other situations along the circumferential direction, which can be carried out with reference to the above-mentioned distribution rules (not shown in the figure).

[0476] 9 , the outer skirt has an inflow edge 323 and an outflow edge 322, facing the inflow side 131 and outflow side 132 of the stent respectively. The outflow edge 322 of the outer skirt is adjacent to the midpoint of the fixed edge of the leaflet and does not exceed the outflow side of the midpoint.

[0477] In one embodiment, the stent as a whole has a waist portion 15 that matches the position of the native valve ring. The stent as a whole is cylindrical. When its generatrix is ​​a curve, the portion with the smallest diameter is the waist portion. Of course, the portion with the smallest diameter can be a straight section with a certain length, and the straight section also has an inflow and outflow side accordingly.

[0478] As shown in FIG1 , the waist portion 15 can be understood as the position with the smallest radial dimension near the middle of the stent, and both sides of the waist portion tend to flare. Preferably, the outflow edge 322 of the outer skirt 32 is located at the waist portion 15 .

[0479] In some embodiments, as shown in FIG2 , the stent 1 as a whole has the aforementioned waist portion 15. The outflow edge of the outer skirt may also be located on the inflow side of the waist portion. This can also be understood as meaning that the outflow edge of the outer skirt is lower than the waist portion along the X-direction in the figure. Preferably, the distance between the outflow edge 322 of the outer skirt and the waist portion 15 corresponds to 0.5 to 1 grid.

[0480] 9 a , a bag structure 33 a is formed between the outer skirt 32 and the inner skirt 31 . The interior of the bag structure 33 a is the accommodating area 33 mentioned above, and the blocking component 4 is located in the bag structure 33 a .

[0481] Preferably, as shown in Figure 11a, the pouch structure protrudes radially from the outer wall of the stent by a distance D1 of 0.5 to 20 mm. Preferably, D1 is 1 to 15 mm. This elevation refers to the state after the artificial implant is released and does not take into account the deformation of the surrounding tissue against the pouch structure and the occlusion component.

[0482] In some embodiments, the pouch structure 33a may adopt a fully enclosed structure or a semi-open structure. As shown in FIG11a , the pouch structure 33a is a fully enclosed structure, and the blocking component is completely wrapped in the pouch structure.

[0483] When the pouch structure 33a is a semi-open structure, the open portion may have openings 331 facing the outflow side and / or the inflow side, with multiple openings 331 spaced apart along the circumference of the stent. As shown in FIG11b , the pouch structure 33a has an opening 331 facing the outflow side; as shown in FIG9 , the pouch structure has an opening 331 facing the inflow side; and as shown in FIG11 , the pouch structure has multiple openings 331 facing both the inflow side and the outflow side.

[0484] The inner skirt 31 and outer skirt 32 described above can be made of the same or different materials, for example, both skirts are made of PU material; or both skirts are made of biomaterial; or the inner skirt is made of PU material and the outer skirt is made of biomaterial; or the inner skirt is made of biomaterial and the outer skirt is made of PU material.

[0485] In some embodiments, at least one of the inner skirt 31 and the outer skirt 32 is made of PU material. The PU material is thin and dense, has high strength, and has a certain elasticity, which solves the pain point of weak suturing force between the two skirts or between the skirt and the leaflet.

[0486] With reference to FIG. 2 and FIG. 3 , some embodiments of the present application further provide an artificial implant, comprising:

[0487] Stent 1 is a radially deformable cylindrical structure with a through-going blood flow channel;

[0488] A plurality of leaflets 7, each leaflet having a fixed edge and a free edge relative to each other, wherein the fixed edge is fixed to the stent, and the free edge is used to control the blood flow channel;

[0489] The skirt 3 includes an inner skirt 31 located radially inward of the bracket and an outer skirt 32 located radially outward of the bracket. The inner skirt and the outer skirt are an integrated structure and are made of PU material.

[0490] The inner skirt 31 and outer skirt 32 can be combined with the above-described embodiments. During the delivery and installation of the artificial implant via the control handle, the stent undergoes compression and release states, causing the mesh to deform during the transition between these two states. Furthermore, for different mesh shapes, the mesh and surrounding bars deform unevenly. Because the skirt is connected to the surrounding bars, the stress generated within the skirt during mesh deformation is also uneven, resulting in localized high stress and even possible tearing of the skirt.

[0491] This application uses a PU skirt, which has the advantages of high elongation and thin thickness, and can prevent the risk of the above-mentioned skirt tearing. Based on the advantage of high elongation, the PU skirt can adapt to grids of various shapes and areas, such as diamond grids with smaller area and smaller deformation, and fishbone grids with larger area and larger deformation.

[0492] Some embodiments of the present application further provide an artificial implant comprising a stent 1, a plurality of leaflets 7, a skirt 3, and a sealing assembly 4, which can be combined with the above embodiments. Specifically, relative to the radial position of the stent, the skirt comprises an inner skirt 31 and an outer skirt 32, both of which are made of PU and are connected to form an integral structure on the inflow side of the stent. The two skirts form a pouch structure 33a, in which at least a portion of the stent and at least a portion of the sealing assembly are located. As shown in FIG11c , the pouch structure encloses the stent foot 14 and can fully enclose the sealing assembly 41a or partially enclose the sealing assembly 41b.

[0493] Referring to Figure 12 (obtained by flattening the inner skirt, outer skirt, and multiple leaflets in Figure 9), the inner skirt 31 has an inflow edge 311 and an outflow edge 312, and the outer skirt 32 has an inflow edge 323 and an outflow edge 322. The outflow edge 312 of the inner skirt is spliced ​​and sutured with the fixed edges 71 of the multiple leaflets. The inflow edge 311 of the inner skirt and the inflow edge 323 of the outer skirt are roughly aligned, and the two can be connected in an integral structure or separately to close the blood flow channel. When the inner and outer skirts are connected in separate parts, they can wrap around the stent or be isolated by the stent.

[0494] The inner skirt is made of the first sheet 5, and the outer skirt is made of the second sheet 51. The division of the inner skirt and the outer skirt is based on the radial position relative to the bracket after the skirt and the bracket are sewn together. The first sheet 5 and the second sheet 51 are the whole piece of material before sewing, and are divided as a whole. Preferably, when the first sheet and / or the second sheet is made of PU material, the thickness range is 0.02 to 0.2 mm; when the first sheet and / or the second sheet is made of biomaterial, the thickness range of the biomaterial is 0.10 to 0.50 mm. The fixing method between the sheets and the sheets and the bracket can be sewing or bonding.

[0495] For example, a sheet made of PU material can be sutured or bonded to the bracket. The above-mentioned bonding refers to fixing and bonding by thinly coating biological glue or PU solution or solvent; for example, if two sheets are both made of PU material, the two sheets can be connected by suture or bonding; for example, if one sheet is a biological material, it can be connected to the bracket or another sheet by suture; sheets of the same material (both PU material or biological material) can also be directly formed into one piece.

[0496] In addition, one of the skirts can also be glued to the blocking component of the other skirt. The bonding refers to fixing and bonding by thinly applying biological glue or PU solution or solvent. In addition, the bonding can be done by wrapping around the outside, partially bonding through the hollow part of the shelf cell, or partially bonding the skirt through the cell of the shelf. The bonding is not limited to between sheets and sheets, but can also be between sheets and foam.

[0497] Based on the first sheet material and the second sheet material, there are many ways to construct the inner skirt and the outer skirt. The following only lists a few of them, but they are not limited to the following ones.

[0498] Referring to Figure 14, a first sheet 5 is fixed to the inner side of the bracket 1, and a second sheet 51 is fixed to the outer side of the bracket. After sewing, neither the first sheet nor the second sheet is rolled up to wrap the end of the bracket, and the inflow end of the bracket is completely exposed, that is, the base 14 is completely exposed outside the bag structure of the two sheets (for example, the end face of the inflow end of the bracket is not wrapped by the sheet, and the first sheet and the second sheet can be connected to each other at the inflow edge to prevent blood from entering the interlayer between the two).

[0499] Referring to Figure 15, a first sheet 5 is fixed on the inner side of the bracket. The first sheet 5 is turned outward on the inflow side of the bracket and wraps the inflow end of the bracket. A second sheet 51 is fixed on the outer side of the bracket and is connected to the turned-out part of the first sheet. The wrapping here can be understood as complete wrapping (as shown in Figure 3) or partial wrapping. Partial wrapping means that a part of the base of the inflow end of the bracket is exposed from the bag structure between the two sheets (not shown in the figure).

[0500] Referring to Figure 16, a second sheet 51 is fixed to the outside of the bracket. The second sheet 51 is turned inward on the inflow side of the bracket and wraps the inflow end of the bracket. The first sheet 5 is fixed to the inside of the bracket and connected to the inward-turned part of the second sheet 51. (The meaning of wrapping here is the same as above)

[0501] Referring to Figure 17, the first sheet and the second sheet are an integral structure and completely wrap the inflow end of the bracket. (Wrapping here is understood as above), and several hollow areas can also be cut out on the sheet to expose a portion of the bracket foot.

[0502] In each of the above-mentioned inner skirt and outer skirt configurations, the sealing component can be distributed in a variety of ways, for example, the sealing component is an integral structure with one of the first sheet and the second sheet, or is bonded to at least one of them, or is clamped between the two, and the radial position of the sealing component is on the inner side or outer side of the second sheet.

[0503] As shown in Figure 14, the sealing assembly 4 can be adhered to the first sheet or the second sheet; as shown in Figure 15, the sealing assembly 4 is integrally formed with the first sheet 5; as shown in Figure 16, the sealing assembly 4 is integrally formed with the second sheet 51; and as shown in Figure 17, the sealing assembly 4 is sandwiched between the first sheet and the second sheet. The sealing assembly shown in these figures is radially located inside the second sheet.

[0504] In some embodiments, referring to FIG. 17 a , the radial position of the blocking component 4 may be outside the second sheet material. In this case, the blocking component 4 may also be connected to the second sheet material by bonding or an integral structure.

[0505] Some embodiments of the present application further provide an artificial implant comprising a stent 1, a plurality of leaflets 7, a skirt 3, and a closure assembly 4, which can be combined with the above embodiments. Referring to FIG. 17 a , the closure assembly 4 is integrally formed with the outer skirt (i.e., the closure assembly 4 and the second sheet are integrally formed) and is located outside the outer skirt.

[0506] In some embodiments, the inflow edge 311 of the inner skirt and the inflow edge 323 of the outer skirt are roughly aligned, and the two are an integral structure or a separate connection (as shown in Figure 12 or Figure 13) to close the blood flow channel. Accordingly, the radial position of the blocking component can be on the inner or outer side of the outer skirt.

[0507] The shapes of the inflow edges of the inner skirt and the outer skirt are independent of each other, and both have a smooth inflow edge (as shown in FIG12 ) or a serrated inflow edge adapted to the bracket grid. As shown in FIG11a and FIG18 , the first sheet and the second sheet can be cut into a serrated shape adapted to the bracket grid and embedded in the bracket grid to reduce the difficulty of loading. From the circumference of the bracket, it can also be understood that the outflow edge of the outer skirt in FIG12 can extend smoothly along the circumference of the bracket, or as shown in FIG11a, the outflow edge of the outer skirt extends along the circumference of the bracket while having axial undulations. Preferably, the degree of axial undulation of the outflow edge 322 of the outer skirt matches the shape of the frame bar of the bracket grid, or matches the axial edge shape of the sealing component 4 (not shown in the figure).

[0508] In some embodiments, the inner skirt and the outer skirt are fixed to each other by at least one of bonding or sutures. For example, when both skirts are made of PU or a sheet of adhesive material, the outflow side of the outer skirt and the inner skirt are fixed and bonded by a thin coating of biological glue or PU solution; for example, when both skirts are made of a sheet of biological material, the outflow side of the outer skirt and the inner skirt are fixed by sutures.

[0509] The inner and outer skirts can be fixed continuously along the circumference of the stent, or fixed at intervals, to accommodate different situations where the outer skirt fully or partially encloses the occluding assembly. For example, in the case of Figures 11a and 17 where the occluding assembly is sandwiched between the first and second sheets, the inner and outer skirts are fixed continuously along the circumference of the stent on their outflow sides, fully enclosing the occluding assembly within the pouch structure. For another example, in Figure 11b, where the outer skirt only partially encloses the occluding assembly, the inner and outer skirts are fixed at intervals along the circumference of the stent on their outflow sides to accommodate the position of the occluding assembly.

[0510] In addition, the outflow side of the outer skirt and the corresponding parts of the inner skirt can also be fixed in the above manner, that is, the outflow side of the outer skirt and the corresponding parts of the inner skirt are continuously fixed or fixed at intervals along the circumference of the bracket.

[0511] In some embodiments, the blocking component is made of polyurethane (PU) with internal voids, which can be understood as a PU foam structure (as shown in FIG28 ). The internal pore size is 5 to 500 microns, and the porosity can be 40 to 95%. Furthermore, the blocking component is a water-swelling material, which means that it expands after absorbing water or body fluids in an in vitro simulated test environment or an in vivo environment. For example, the swelling material deforms when absorbing water in an in vivo environment. Furthermore, the self-developing material can be further used, which means that its chemical or physical structure can be directly detected by imaging equipment.

[0512] The occluding component 4 utilizes deformable PU foam, which can be designed into a variety of shapes to accommodate the stent grids of different stents. Furthermore, due to the PU foam's compressibility and self-expanding properties, it automatically adjusts its height and thickness when subjected to uneven external forces. Simultaneously, it absorbs blood to self-expand, tightly fitting the valve annulus and preventing paravalvular leakage. Furthermore, the PU foam occluding component does not increase the size of the delivery system and can even accommodate smaller radial dimensions. Therefore, artificial implants using the PU foam occluding component are also suitable for patients with high calcification and vascular stenosis. Furthermore, the PU foam has a porous structure and good compressibility. During contact and friction with the catheter assembly of the interventional delivery system or internal tissue, it deforms to disperse stress points, making it less susceptible to tearing.

[0513] When the blocking component and the skirt are made of the same material PU (the molecular weight or hardness ratio is not required to be strictly the same when processed separately), the blocking component and the PU skirt are bonded or processed as one piece, which can obtain a greater peel strength. Therefore, when the blocking component is exposed, it is not easy to detach even if it contacts and rubs against the catheter component of the interventional delivery system or the internal tissue, thereby avoiding the safety risk of detachment of the blocking component.

[0514] The adhesive can be a solution of the same PU. The solvent in the solution dissolves the PU at the bonding site, allowing the two to fuse together. When the solvent evaporates, the PU precipitates, achieving the desired bond. This method does not introduce new adhesives, as the same materials bond together, resulting in a tight and secure interface.

[0515] In some embodiments, the blocking assembly has multiple arrangements, of which only a few are listed below, but are not limited to the following:

[0516] The blocking assembly may include a plurality of blocking blocks arranged along the circumference of the stent (as shown in FIG8 ), where “plurality” may be understood as two or more;

[0517] Or the blocking component is a ring-shaped member 42 as a whole and is located on the periphery of the stent, and the blocking component is directly sleeved on the periphery of the stent (as shown in FIG. 22 );

[0518] Or the blocking component is directly sleeved on the outer periphery of the outer skirt (as shown in FIG7 ).

[0519] Some embodiments of the present application further provide an artificial implant comprising a stent 1, multiple leaflets 7, a skirt 3, and a sealing assembly 4, which can be combined with the above embodiments. The sealing assembly comprises a plurality of sealing blocks arranged circumferentially along the stent. The plurality of sealing blocks are arranged in multiple groups spaced apart along the stent circumference, with each group containing at least one sealing block 43. Adjacent groups are separated by spacers 44, and all sealing blocks avoid each spacer circumferentially. That is, the distribution area of ​​all the plurality of sealing blocks 43 is spaced apart along the stent circumference.

[0520] The blocking blocks are arranged in two to nine groups, for example, three to six groups, at intervals along the circumference of the stent. There are 1 to 10 blocking blocks in the same group, and the distribution area of ​​the blocking blocks in the same group is continuously distributed along the circumference of the stent. Here, "continuous distribution" can be understood as not considering the interruption of grid bars or node parts (such as grid node 121 in the figure) between the blocking blocks in the same group, and the interruption part can generally be closed after the blocking blocks are adaptively deformed by tissue compression. As shown in Figure 22a, the blocking blocks are arranged in four groups at intervals along the circumference of the stent, and the groups are evenly distributed along the circumference of the stent. The same group includes two continuously distributed blocking blocks.

[0521] In some embodiments, as shown in FIG22 b , the distribution areas of all the multiple blocking blocks are continuously distributed in the circumferential direction of the stent, that is, there is no spacer area 44 in the circumferential direction of the stent.

[0522] In some embodiments, the radial position of the blocking block is on the inner side of the outer skirt, and each blocking block is embedded in the corresponding stent grid. Each blocking block can be connected to the inner skirt and / or the outer skirt (as shown in Figure 22b, each blocking block is bonded to the inner skirt); or each blocking block is randomly filled between the two skirts (not shown in the figure).

[0523] In some embodiments, within the same grid, the blocking blocks may be distributed in a variety of ways, such as in FIG23 where the support grid 11 includes only one continuously distributed blocking block 43 ; or in FIG24 where the support grid 11 includes multiple blocking blocks 43 arranged at intervals.

[0524] The stent grid is multi-circle, including the open grid 111 and the closed grid 112. All blocking blocks can be distributed in only one circle, or in multiple circles. As shown in FIG8 , the blocking blocks 41a are distributed in only one circle of closed grid 112 on the stent.

[0525] As shown in FIG9 , all the blocking blocks are distributed in two circles, one in the open grid 111 and the other in the closed grid 112 . The blocking blocks in two adjacent stent grids are staggered along the stent axis.

[0526] Some embodiments of the present application further provide an artificial implant, comprising a stent 1, a plurality of leaflets 7, a skirt 3, and a blocking assembly 4, which can be combined with the above embodiments. The blocking blocks in two circumferentially adjacent stent grids are staggered along the stent axis.

[0527] Along the axial direction of the stent, the two sides of the blocking block itself are opposite wide sides and narrow sides, and the blocking blocks in two adjacent stent grids have opposite wide sides.

[0528] Referring to Figure 25a, along the axial direction of the stent (such as the X direction in the figure), the two sides of the blocking block itself (taking the blocking block 43 as an example) are opposite wide sides 431 and narrow sides 432, and the blocking blocks in two adjacent stent grids have opposite wide sides, that is, the corresponding blocking blocks 43 and 43a in the adjacent closed grids 112a and 112b have opposite wide sides. Preferably, the wide sides of all blocking blocks are connected to each other and extend continuously along the circumference of the stent (without considering the interruption of the grid frame or node parts, the interruption part can generally be closed after the blocking block is adaptively deformed by tissue compression).

[0529] In some embodiments, along the radial perspective of the stent, the shape of the blocking block 43 can be circular, elliptical, rectangular, diamond (as shown in FIG. 23 ), triangular (as shown in FIG. 24 ) or hexagonal (as shown in FIG. 25 ).

[0530] Each blocking block is embedded in the corresponding stent grid 11. From the radial perspective of the stent, the blocking block can be distributed throughout the stent grid or only in a portion of the stent grid 11. The blocking block can be distributed in the center of the stent grid 11 (such as the blocking block 43 in Figure 25) or near one end in the axial direction (such as the blocking block 43 in Figure 25a).

[0531] In some embodiments, the same stent grid 11 includes two blocking blocks spaced apart in the axial direction, and each blocking block is adjacent to one axial end of the stent grid.

[0532] From the longitudinal section of the blocking block, the blocking block 43 has an inner side 433 facing the bracket and an opposite outer side 434. The inner side 433 is in contact with the inner skirt 31, and the edge shape of the outer side 434 is a broken line, a smooth curve or a combination of the two.

[0533] When the outer edge of the blocking block 43 is a broken line, the longitudinal section of the blocking block is generally triangular (as shown in FIG. 26 ), rectangular or trapezoidal (as shown in FIG. 26 a ).

[0534] As shown in Figure 27, when the outer edge of the blocking block 43 is a smooth curve and has a radially highest point (such as point P in the figure, which is roughly the maximum thickness of the blocking block), preferably, the axial position of the highest point P in the bracket grid 11 is closer to the inflow side.

[0535] As shown in FIG. 27 a , the outer edge of the blocking block 43 is a shape formed by combining a broken line and a smooth curve. The longitudinal section of the blocking block is roughly B-shaped and has at least two highest points P.

[0536] After implantation, the various shapes of the occluder adapt to the annular shape due to force applied. The porous material absorbs blood, filling the annular gap and preventing paravalvular leakage. The Type B occluder, in particular, has a central depression positioned precisely near the annulus, locking it in place and providing both a sealing effect and improved valve anchoring.

[0537] Some embodiments of the present application further provide an artificial implant, comprising a stent 1, a plurality of leaflets 7, a skirt 3, and a closure assembly 4, which can be combined with the above embodiments. Referring to Figures 27a and 30, the closure assembly forms at least two circles of crests on the periphery of the stent, the two circles of crests 45 being arranged axially along the stent and forming a trough 46 between each other that can accommodate the native valve ring, and the same circle of crests is composed of a plurality of closure blocks spaced circumferentially (as shown in Figure 27a, a portion of the plurality of closure blocks can be embedded in the stent grid, and the periphery is wrapped by the outer skirt) or a closure ring continuously distributed along the circumference (as shown in Figure 30).

[0538] Preferably, viewed along the radial direction of the stent, the thickness of the blocking block may be uniform or non-uniformly distributed, wherein the maximum thickness is 0.5 to 5 mm.

[0539] From the perspective of the position distribution of the blocking component in the axial direction of the stent, it is basically close to the inflow side, and the blocking component as a whole spans 0.5 to 3 grids, for example, 0.5 to 2 grids, along the axial direction of the stent.

[0540] In some embodiments, when the sealing component as a whole is a ring-shaped member 42, the ring-shaped member is looped around the stent and is located in the gap between the outer skirt and the inner skirt (i.e., inside the bag structure), the longitudinal cross-section of the ring-shaped member 42 can adopt a variety of shapes, that is, when the stent is in a fully expanded state, the longitudinal cross-sectional shape (outer contour) of the ring-shaped member is roughly circular, truncated circle (such as the semicircle shown in Figure 17), trapezoidal, rectangular, elliptical or B-shaped, triangular, etc., as shown in Figures 19 to 21, which illustrate some cross-sectional shapes of the ring-shaped members.

[0541] When the blocking component 4 uses a plurality of separate blocking blocks 43, there are many installation positions for the blocking component, and only a few of them are listed below, but are not limited to the following ones.

[0542] In some embodiments, the outer skirt surrounds the outside of the occluding assembly, and the outer skirt can cover all or part of the occluding assembly. Referring to Figure 28, the occluding assembly is fixed to the inner skirt 31 and protrudes from the radial inside of the stent through the corresponding grid to the radial outside of the stent. The outer skirt 32 surrounds the outside of the occluding assembly and partially covers the occluding assembly.

[0543] As shown in FIG29 , the blocking component is fixed to the inner side of the outer skirt 32 and is located in the sandwich layer between the outer skirt 32 and the inner skirt 31 , and the outer skirt 32 wraps the entire blocking component.

[0544] In the above two installation positions, the blocking component is wrapped in the radial gap between the inner skirt and the outer skirt, so that when the artificial implant is transported or in place in the body, the blocking component is prevented from contacting and rubbing with the catheter component or the body tissue, which is safer.

[0545] 30 , the blocking component is fixed to the outside of the outer skirt 32 so that the blocking component is exposed. When the artificial implant is delivered or in place in the body, it is in direct contact with the body tissue. The shape of the blocking component is more adaptable and easier to assemble.

[0546] The blocking component and the skirt can be fixed in an integral manner or in a separate manner. For example, the blocking component can be directly integrally formed with the PU skirt, or the blocking component can be bonded by thinly coating biological glue or PU solution.

[0547] In some embodiments, as shown in Figures 28 and 30, on the longitudinal section of the sealing component, the outer edge shape of the sealing component 4 has two peaks 45 and a trough 46 between the two peaks (such as the B shape mentioned above), and accordingly, the outflow side of the outer skirt can be located at the trough position.

[0548] During the implant manufacturing process, referring to Figures 31 to 31a, the outer skirt 32 and inner skirt 31 are connected to the stent 1 via sutures 62. At least one of the outer and inner skirts is provided with a reinforcement 6 for partial or overall reinforcement. During the threading path of the suture 62, some of the suture will pass around the reinforcement, thus resolving the problem of weak suture strength. Preferably, the reinforcement is made of PU or PET.

[0549] The reinforcement can be in various shapes, such as sheet, strip, ring, etc., and can be fixed in various ways, such as pre-embedded or bonded to the inner skirt and / or outer skirt.

[0550] Preferably, the reinforcement member may be a suture reinforcement line 64 or a reinforcement fabric 61 pre-embedded in the skirt, or the reinforcement member may be a reinforcement gasket 65 directly abutting against the outer skirt and / or the inner skirt.

[0551] The reinforcements can be distributed as a whole or partially. For example, the reinforcements shown in Figure 33a are distributed throughout the inner skirt to enhance the overall strength of the inner skirt; or the reinforcements are only located on the outflow side of the inner skirt and connected to the fixed edge of the leaflet (as shown in Figure 31a and Figure 33d), that is, the edge of the reinforcement is aligned with the outflow side of the inner skirt, and only the outflow side of the inner skirt is strengthened.

[0552] In some embodiments, the reinforcing gasket 65 can be located outside the outer skirt, inside the inner skirt, or between the radial gaps between the outer and inner skirts. The reinforcing gasket 65 can be integrally formed with the skirt against which it abuts, or separately secured by at least one of bonding or suture. For example, in Figure 31a , the reinforcing gasket 65 is located between the radial gaps between the outer and inner skirts and is directly bonded to the inner skirt.

[0553] In some embodiments, the suture reinforcement line 64 can be pre-buried in the skirt during the skirt synthesis process. Preferably, the reinforcement line is pre-buried in the outflow edge of the outer skirt to enhance the connection strength between the outflow edge of the outer skirt and the bracket, thereby achieving higher connection strength when the outer skirt contacts and rubs against the tissue in the body.

[0554] As shown in FIG32 , the suture reinforcement line 64 extends along the circumference of the stent to form a line loop. The line loop may be one or more circles, wherein the multiple circles of the line loop are arranged at intervals or extend continuously in a spiral manner to achieve the effect of local reinforcement of the skirt.

[0555] From the perspective of the circumference of the stent, the suture reinforcement line 64 extends along the circumference of the stent to form a line loop. As shown in the figure, the line loop can be one circle or multiple circles, wherein the multiple circles of the line loop are arranged at intervals or extend continuously in a spiral manner.

[0556] In some embodiments, the reinforcing fabric 61 can be pre-embedded in the skirt during the skirt synthesis process, or each can be pre-formed and then stacked and fixed together. For example, in Figure 33a, the inner skirt 31 is pre-embedded or stacked (for example, fixed by bonding) with the reinforcing fabric 61. In Figure 33b, the inner skirt 31 is mainly provided with the reinforcing fabric 61 on the outflow side, which can enhance the suture force between the outflow edge 312 and the leaflet fixed edge and reduce the risk of tearing. In combination with the material of the skirt and the fixing method of the occluding component and the skirt described above, the arrangement of the reinforcing members also has various situations. The reinforcing members avoid or pass through the occluding component, and the sutures avoid or pass through the occluding component 4.

[0557] The inner skirt 31 can be a PU film, which also corresponds to the flexible substrate of the following embodiments. The reinforcing fabric 61 can be a PET fabric, which also corresponds to the reinforcing component of the following embodiments. The PET fabric can reinforce the PU film as a whole or partially. The two can be overlapped and fixed to each other as sheets. The overlapping area is the reinforced part. The fixing method can be bonding, which constitutes an anti-valvular leakage skirt. The corresponding improvement methods are specifically provided in the following embodiments of the anti-valvular leakage skirt.

[0558] When setting up the blocking component 4 , it can be configured as a plurality of blocking blocks arranged at intervals. The plurality of blocking blocks can also be adjacent to each other. The plurality of blocking blocks can also be made of PU material and fixed to the inner skirt 31 .

[0559] The sealing block adopts a deformable structure and is connected to the inner skirt 31 by curing of a polyurethane solution. The following provides corresponding improvements on the materials of each part and the connection process in each embodiment of the adaptive anti-paravalvular leakage material.

[0560] For example, in FIG33b , the blocking assembly 4 is located in an area on the inner skirt 31 exposed to the reinforcing fabric 61 , basically close to the inflow side, and the blocking assembly 4 can be interconnected by reinforcing lines 64b to further improve strength.

[0561] Some embodiments of the present application further provide an artificial implant comprising a stent 1, multiple leaflets 7, a skirt 3, and a closure assembly 4, which can be combined with the above embodiments. The skirt has a reinforcement member, which is connected to the stent via sutures threaded through the reinforcement member, and the reinforcement member can avoid the closure assembly.

[0562] As shown in Figure 33c, the outer skirt can be used in combination with the occlusion component 4 to reduce paravalvular leakage, wherein the outer skirt 32 is made of PU material and is an integral structure with the occlusion component 4. The position of the reinforcement line 64a avoids the occlusion component, and the outflow side and / or inflow side of the outer skirt can be locally reinforced. Accordingly, the suture also avoids the occlusion component when passing around the reinforcement line 64a.

[0563] The position of the reinforcement line 64b can pass through the blocking component 4, that is, it can serve as a pulling line between multiple blocking blocks. It can also be combined with the pulling line 22 in Figures 48 and 49 and related implementations. The pulling line connects the blocking blocks to each other. When the suture passes around the reinforcement line 64b, it can also pass through the blocking component. It not only strengthens the connection strength, but the reinforcement line 64b is equivalent to a pre-connection before the blocking component is connected to the bracket, which is convenient for processing.

[0564] Accordingly, the inner skirt can also be reinforced in whole or in part by a reinforcing fabric, and the local reinforcement can be distributed on the outflow edge and / or the inflow edge. For example, in the embodiment of Figure 33d, the inner skirt 31 is provided with a reinforcing fabric 61 on the outflow side, and the outflow side edges of the inner skirt 31 and the reinforcing fabric 61 are aligned. In other embodiments, the outflow side edges of the inner skirt 31 and the reinforcing fabric 61 can be offset from each other, for example, the reinforcing fabric 61 further extends beyond the outflow side of the inner skirt, forming a structure as shown in Figure 87.

[0565] The inner skirt 31 and the outer skirt 32 are an integral structure or fixed separately. Combined with Figure 34a and Figure 34b, the inner skirt 31 and the outer skirt 32 are made of an integral PU material and are an integral structure with the sealing component. The inner skirt 31 is located on the inner side of the stent 1 and is sutured to the leaflet. The outer skirt 32 is turned outward to the outside of the stent 1. The dotted line position between the inner skirt 31 and the outer skirt 32 (Figure 33d) roughly corresponds to the inflow side edge of the stent 1. The reinforcement line 64a in the figure avoids the sealing component, and the suture also avoids the sealing component 4 when passing around the reinforcement member, and locally enhances the outflow side of the outer skirt 32; similarly, the reinforcement lines 64c and 64d in the figure locally enhance the inflow sides of the inner skirt 31 and the outer skirt 32 respectively; the reinforcement line 64b can also be set in the figure to pass through the sealing component 4.

[0566] In other embodiments, the outer skirt may be made of PET fabric and connected to the inner skirt to form a structure as shown in FIG90 .

[0567] In Figure 34a, the outer skirt 32 is folded to the outside of the bracket 1 and then fixed to the bracket 1, and the blocking component 4 is located on the outside of the outer skirt 32. In Figure 34b, the blocking component 4 is located on the inside of the outer skirt 32.

[0568] In the prior art, operators typically embed imaging markers (such as imaging gold wires) around the stent and use equipment to observe its release within the body. To facilitate observation of the release position and morphology of the artificial implant within the body, the present application pre-embeds imaging markers 63 in at least one of the outer skirt, inner skirt, and occlusion assembly.

[0569] Some embodiments of the present application further provide an artificial implant comprising a stent 1, a plurality of leaflets 7, a skirt 3, and a closure assembly 4, which can be combined with the above embodiments. The skirt and / or closure assembly are pre-embedded with imaging markers, and the joints between adjacent leaflets at the stent portion are defined as joints 73. The circumferential positions of the imaging markers correspond to the respective joints, and there is at least one group of imaging markers, each of which is axially positioned adjacent to the inflow side of the stent and axially spaced from the leaflets to accommodate at least the native annulus.

[0570] 35 to 41 , along the axial direction of the stent, the development mark 63 is adjacent to the inflow side of the stent. The development mark may be formed in at least one of the following ways:

[0571] The development mark is pre-formed and used as an embedded part in the synthesis process;

[0572] The developer mark is mixed into at least one raw material in the synthesis process.

[0573] Especially when the outer skirt or inner skirt is made of PU material, the developing mark can be embedded in the mold during PU synthesis. If necessary, a notch of corresponding shape can be cut on the mold to facilitate the placement and positioning of the developing mark, or mixed in the PU solution.

[0574] Preferably, the development mark can be a strip, sheet or block embedded part, or a powder mixed into at least one raw material.

[0575] In some embodiments, the development mark is embedded in the skirt (which can be an inner skirt or an outer skirt or a skirt of an integral structure). As shown in FIG35 , the development mark 63 is strip-shaped and extends along the axial or circumferential direction of the bracket. The development mark 63a extends along the circumferential direction of the bracket and can indicate the orientation of the bracket; the development mark 63b extends along the axial direction of the bracket, especially the development mark 63b extends to the outflow side of the outer skirt, which can accurately indicate the circumferential position of the bracket. The development mark 63a and the development mark 63b can avoid or intersect with each other. As shown in FIG36 , the development mark 63 is block-shaped and is arranged at intervals along the axial and circumferential direction of the bracket. The circumferential position of the development mark corresponds to each joint part, which can also accurately indicate the orientation and circumferential position of the bracket.

[0576] As shown in FIG37 , the developing mark 63 is in powder form and is mixed into and dispersed in a raw material during the synthesis of the PU skirt. The circumferential position of the developing mark may also correspond to the lowest point of the fixed edge of the leaflet.

[0577] In some embodiments, the developing mark may also be pre-buried in the sealing component. For example, as shown in Figure 38, when the sealing component is a ring-shaped member 42, the strip-shaped developing mark 63c is arranged along the circumference of the ring-shaped member and can form one or more circles around the bracket, or the block-shaped developing mark 63d is arranged at intervals along the circumference of the ring-shaped member.

[0578] As shown in FIG39 , when the blocking component is a plurality of blocking blocks 43 , at least two (eg, three to six or even more) of the blocking blocks are provided with developing marks 63 (which may be in the form of strips, blocks, or powder).

[0579] 40 , the development mark is roughly located in the center area (center point or center line) of the blocking block.

[0580] In some embodiments, as shown in FIG. 41 , when the blocking assembly is a plurality of B-shaped blocking blocks 43 , the development mark includes a first mark 631 and a second mark 632 , and the two marks are respectively located at corresponding wave crests.

[0581] When the blocking block 43 is in place near the valve annulus in the body, the two wave peaks are located on both sides of the valve annulus. After self-expansion, the B-shaped blocking block can clamp the valve annulus, which has a better effect in preventing leakage. The imaging mark located in the wave peak can accurately feedback the position of the valve annulus.

[0582] In some embodiments, when the occluding assembly is a plurality of B-shaped occluding blocks 43, the imaging marker may also be located at the trough, exactly corresponding to the position of the valve annulus.

[0583] The present application also provides the preparation methods of the PU skirt, PU foam and the integrated molding of the two as described above, as well as the preparation methods of local or overall reinforced structures of the two materials, and the preparation methods of PU skirts or PU foam materials with developing marks or the integrated molding materials of the two, wherein the PU skirt is cut from a PU film, so the following only provides the preparation method of the overall PU film.

[0584] The preparation method of the PU film is as follows:

[0585] A1: Dissolve implantable polyurethane (PU) particles (i.e., polyurethane) in dimethylformamide (DMF) solvent to obtain a PU solution (i.e., polyurethane solution). The polyurethane content in the polyurethane solution is 5% to 20% (w / v). When dissolving the PU particles, use a mechanical stirrer to accelerate the dissolution rate at room temperature or heated (18 to 90°C).

[0586] A2: Pour a certain amount of PU solution into a flat mold, place the flat mold in a 30-70 degree oven for 7-24 hours to produce a PU film. The thickness of the film can be adjusted according to the concentration of the solution and the height of the solution after being poured into the mold. The thinnest can reach 0.02mm.

[0587] The preparation method of PU foam is as follows:

[0588] B1: dissolving implantable polyurethane particles in a DMF solvent to obtain a polyurethane solution, and mixing the polyurethane solution with sodium chloride to obtain a premix for preparing a foam, wherein the diameter of the sodium chloride solid particles is about 5 to 500 microns, and the mass fraction of sodium chloride in the premix is ​​50% to 80%; or a gas-formed foam structure;

[0589] B2: Fill the premix into a mold for shaping, solidification, cooling, and then placing it in water (normal temperature or warm water). The mold should be designed based on the shape of the plugging component.

[0590] B3: After demoulding, the sample is placed in water for further washing and drying.

[0591] As for the preparation method of the foam, the foam preparation process using chemical, gas, solid and other methods provided by the existing technology in the industry can be used, including but not limited to the above methods (described as examples only).

[0592] The preparation method of the integrated molding of PU film and PU foam is as follows:

[0593] C1: dissolving implantable polyurethane (PU) particles in DMF solvent to obtain a PU solution (PU particle content of 5% to 20% (w / v)), and mixing the PU solution with sodium chloride to obtain a premix for preparing the foam, wherein the sodium chloride has a diameter of about 5 to 500 microns and a mass fraction of sodium chloride in the premix of 50% to 80%;

[0594] C2: Fill the premix into the mold and compact it. The shape of the mold can be changed according to the design of the plugging component;

[0595] C3: Heat the PU film obtained in step A2 above (40-80°C), then spread it on the mold surface and let it stand or put it in an oven for a certain period of time;

[0596] C4: After demoulding, the sample is placed in water to dissolve the salt particles, and then dried to obtain a material in which the PU foam and PU film are integrally formed.

[0597] The preparation method of PU skirt with development mark is as follows:

[0598] D1: dissolving the implantable PU particles in DMF solvent (PU particle content is 5% to 20% (w / v)) to obtain a PU solution;

[0599] D2: Spread the developed gold wires flatly in the mold, then pour in a certain amount of PU solution, and place the mold in a 30-70 degree oven for 7-24 hours to obtain a PU film with developed gold wires. The number of gold wires can be adjusted according to the development requirements.

[0600] The preparation method of the integrated material of PU film and PU foam with a developing mark is as follows:

[0601] E1: dissolving the implantable PU particles in DMF solvent to obtain a PU solution (PU particle content of 5% to 20% (w / v));

[0602] E2: PU solution is mixed with sodium chloride to obtain a premix for preparing foam, wherein the diameter of the sodium chloride is about 5 to 500 microns and the mass fraction of sodium chloride in the premix is ​​50% to 80%;

[0603] E3: Fill the premix into the mold, embed the developable metal or gold wire, and then compact it. The mold shape can be changed according to the design of the plugging component;

[0604] E4: Heat the PU film obtained in step A2 above at room temperature or preheat (30-70°C), then spread it flat on the mold surface, cover it with a piece of flexible silicone, and let it stand or put it in an oven for a certain period of time;

[0605] E5: Take out the mold and cool it at room temperature, then put it into water (room temperature or warm water);

[0606] E6: After the sample is removed from the mold, it is placed in water to dissolve the salt particles;

[0607] E7: After drying, the PU foam and PU film can be integrated into a material.

[0608] Preparation Example A

[0609] The preparation method of PU film is as follows:

[0610] A1: dissolving implantable polyurethane particles (i.e., polyurethane) in dimethylformamide (DMF) solvent to obtain a polyurethane solution (i.e., polyurethane solution), wherein the polyurethane content in the polyurethane solution is 8% to 14% (w / v);

[0611] A2: Pour a certain amount of PU solution into a flat mold, place the flat mold in a 70°C oven for 12 hours to produce a PU film with a thickness of 0.03-0.05 mm.

[0612] Preparation Example B

[0613] The preparation method of the integrated molding of PU film and PU foam is as follows:

[0614] C1: dissolving implantable polyurethane (PU) particles in DMF solvent to obtain a PU solution (PU particle content of 8% to 14% (w / v)), and mixing the PU solution with sodium chloride to obtain a premix for preparing the foam, wherein the sodium chloride has a diameter of approximately 500 μm and the mass fraction of sodium chloride in the premix is ​​80%;

[0615] C2: Fill the premix into a diamond-shaped mold and compact it;

[0616] C3: The PU film obtained in step A2 of preparation example A is heated (80), then spread flat on the mold surface, covered with a piece of flexible silicone, and left to stand or placed in an oven for a certain period of time;

[0617] C4: After demoulding, the sample is placed in water to dissolve the salt particles, and then dried to obtain a material in which the PU foam and PU film are integrally formed.

[0618] Performance Characterization 1

[0619] Using the preparation method of Preparation Example A, five samples were prepared under the same conditions, recorded as PU film sample 1 to PU film sample 5, and the tensile strength and elongation of the PU film were tested. The tensile strength test method is as follows:

[0620] Set the load value of the universal material testing machine to zero, clamp the sample in the fixture of the tensile machine, carefully and symmetrically adjust the sample so that the tension is evenly distributed on the cross section of the sample, reset the elongation measurement system to zero, set the stretching rate to 5mm / min, and then start the tensile machine until the sample is broken. Record the maximum load during the stretching process and then convert it into tensile strength. Record the data as shown in Table 1 below:

[0621] Table 1

[0622] As can be seen, the PU membrane material has good elasticity and high elongation, and can conform to the deformation of the stent during valve loading, without applying additional force to the stent, thereby reducing the risk of valve stent folding. Furthermore, the PU membrane produced in this application is much stronger than porcine pericardium. Therefore, when the same strength and elongation requirements are preset, the skirt of this application can be made of a relatively thin PU membrane, which is beneficial for the loading and recovery of the interventional valve and its passability in human blood vessels.

[0623] Performance Characterization 2

[0624] Using the preparation method of Preparation Example B, five samples were prepared under the same conditions, designated as PU film / PU foam integrated sample 1 to PU film / PU foam integrated sample 5. The samples consisted of a PU film and a PU foam, with a PU film thickness of 0.02 to 0.2 mm and a PU foam height of 0.5 to 5 mm. The tensile strength was tested, and the data were recorded in Table 2 as follows:

[0625] Table 2

[0626] The PU film base and PU foam are made of the same material and have a strong bond. Since the foam itself is porous and discontinuous, the actual fracture point of the sample during the tensile test is the PU foam.

[0627] In addition, in order to more intuitively test the strength of the bonding between PU foam and PU film and compare it with the bonding between PET film and PU foam, samples shown in Figures 42a to 42c were prepared. The sample has a PET film 100 and a PU film 200, and has an interlayer 300 made of the same material as the PU foam. Forces F1 and F2 of equal magnitude and opposite directions are applied to the PET film 100 and the PU film 200, and a peeling test is performed. The final test result is: the PET film 100 and the interlayer 300 are separated, while the PU film 200 and the interlayer 300 remain fixed.

[0628] It can be seen from this that the PU film base and PU foam are made of the same material, and the bonding strength between the two is obviously higher than that between PU foam and PET film.

[0629] Existing transcatheter aortic valve implantation technology generally uses a delivery system to deliver an artificial implant (in this application, an artificial heart valve is used as an example) to the diseased native tissue, replacing the native valve and restoring normal valve function. The existing artificial heart valve includes a stent 162 and leaflets 165. The two ends of the stent 162 are respectively an inflow side 1621 and an outflow side 1622. The interior of the stent 162 is a blood flow channel 1623. The leaflets 165 are multiple pieces, and each leaflet 165 cooperates with each other in the blood flow channel 1623 to relatively open or close the blood flow channel 1623.

[0630] Referring to Figure 43, after the artificial implant 16 is basically in place in the body, when the valve is open, blood flows from the inflow side 1621 through the blood flow channel 1623 to the outflow side 1622 along direction A; when the valve is closed, the pressure difference between the inflow side and the outflow side is too large and exceeds the adjustment capacity of the valve, causing part of the blood to flow back from the periphery of the stent 162 along direction B, causing abnormal blood flow.

[0631] In order to alleviate the leakage between the periphery of the stent 162 and the native valve tissue, some existing artificial implants sew anti-leakage devices on the inflow side of the stent, such as sewing a skirt on the outside of the stent, wrapping it with water-absorbing and expanding materials to achieve the effect of preventing leakage, but this will cause problems such as the radial size of the artificial implant being too large after being compressed.

[0632] 44 to 47 , an embodiment of the present application provides an artificial implant device for preventing peritoneal leakage. The artificial implant 16 has a grid structure 161 and a cylindrical stent 162. The interior of the stent 162 is a blood flow channel. The multiple leaflets 165 in the stent cooperate with each other in the blood flow channel to relatively open or close the blood flow channel.

[0633] The anti-circumferential leakage device 2 includes multiple sealing blocks 21 and pulling lines 22. The multiple sealing blocks 21 are arranged along the circumference of the bracket 162 and embedded in the grid structure 161 at the corresponding position. The multiple sealing blocks 21 are surrounded and closed along the circumference of the bracket 162. As shown in Figure 46, when viewed along the cross-sectional direction of AA in Figure 43, all grid structures 161a in the same circle are filled and embedded with the sealing blocks 21.

[0634] The stent 162 is roughly cylindrical, that is, it has a corresponding axial direction (axial direction), a radial direction perpendicular to the axial direction, and a circumferential direction arranged around the axis. The grid structure can be understood as a cylindrical side wall with a hollow area, and the edge of the hollow area is the frame bar that forms the grid. There is no strict restriction on the size and specific shape of the grid. In the axial direction of the stent, according to the normal blood flow direction in the body, they are the inflow side 1621 and the outflow side 1622. The stent itself can be cut or woven from a tube, and the corresponding material is used according to the release method in the body (such as self-expansion or balloon expansion).

[0635] The pull wire of the present application can be made of suitable materials and wire diameters to ensure strength, and the independent occluding blocks are connected to each other. The occluding blocks and the pull wire can be connected to each other by bonding, suturing, or integral mold forming. The occluding blocks 21 are arranged in sequence along the circumference of the stent. Under the action of the pull wire, the occluding blocks 21 that were originally independent of each other are connected to the pull wire to form a long chain-like whole. Each occluding block adopts a deformable structure, such as relying on its own elasticity or loose porous structure, so as to obtain a smaller outer diameter when loaded and compressed, and after releasing and expanding in the body, it abuts against the surrounding tissues to ensure the effect of preventing circumferential leakage.

[0636] As shown in Figure 47, after each blocking block 21 is embedded in the corresponding grid structure 161a and released in the body, at least a portion of the blocking block 21 protrudes radially from the outside of the stent, that is, the protruding area 21a, and the area within the cell is the non-protruding area 21b. The blocking block adopts a deformable structure so that the thickness of the protruding area 21a itself can be variable, or the overall thickness of the protruding area 21b can be variable.

[0637] The improved anti-perivalvular leakage device of the present application utilizes a pull line to release the mutual restraint of the occluding blocks during suturing, eliminating processing errors and, in particular, minimizing the accumulated errors in circumferential matching, significantly reducing the difficulty of suturing. After the artificial implant of the present application is inserted into the body and reaches the predetermined position, the protruding region 21a of the anti-perival leakage device compresses against the surrounding tissue, producing an adaptive fit and fully filling the gap between the two, thereby resolving the problem of paravalvular leakage.

[0638] Referring to Figures 48 to 50, the blocking blocks 21 are arranged in multiple circles in correspondence with the grid structure. The circles are arranged along the axial direction of the stent, and the adjacent circles are staggered with each other. This staggered arrangement has great advantages in the compression and gripping stage of the artificial implant and the expansion stage after it is in place in the body. As shown in Figure 48, the compression directions of adjacent blocking blocks are staggered in the circumferential direction and are not in the same plane, which significantly reduces the pre-tightening force of the compression and grip. During the expansion stage of the blocking block, the protruding area of ​​the blocking block has a larger expansion range, which enhances its own adaptability and can fill a larger range of gaps to ensure the anti-circumferential leakage effect.

[0639] As shown in FIG49 , after the blocking blocks in FIG48 are unfolded, the blocking blocks in the same circle are connected only by the pulling wire 22 , which not only meets the requirements of circumferential connection and positioning of the blocking blocks, but also minimizes the size of the artificial implant after being pressed and gripped.

[0640] Among them, each blocking block and the pull line can be connected to each other by various methods such as bonding, suturing, or integral molding. However, since the bonding and suturing processes still have human operational errors (such as suturing errors, bonding errors, etc.), and considering the simplification of the molding process, in order to ensure that each blocking block can completely correspond to the grid structure on the stent, connecting strips 23 integrally formed with the blocking blocks are provided between adjacent blocking blocks 21 in the same circle. That is, the spacing and positioning of the blocking blocks are performed by connecting strips 23 during the molding stage. The connecting strips can be used simultaneously with the pull line and also serve as the pull line, both of which can connect the blocking blocks to form a blocking block ring, further enhancing the connection strength and facilitating subsequent suturing.

[0641] From the perspective of the individual grid structures, the grid structures on the bracket close to the inflow side 1621 are divided into two types: a closed grid 1611 and an open grid 1612. According to the corresponding relationship between each blocking block and the grid structure, the blocking block 211 is completely embedded in the closed grid 1611, and the blocking block 212 is partially embedded in the open grid 1612.

[0642] From the perspective of the overall structure of the stent, the ring layer closest to the inflow side 1621 is an open grid layer composed of open grids 1612, and the ring layer adjacent to the open grid layer is a closed grid layer composed of closed grids 111. According to the correspondence between each blocking block and the grid structure, the blocking blocks on the inflow side 1621 are arranged in two circles. The first circle is composed of a grid structure completely filled by blocking blocks 211, i.e., the blocking blocks are completely embedded in the closed grid layer. The second circle is composed of a grid structure partially filled by blocking blocks 212, i.e., the blocking blocks are partially embedded in the open grid layer. In the first circle, there is a spacing portion 241 between adjacent blocking blocks 211, and each blocking block 212 in the second circle is located in the corresponding spacing portion, presenting the above-mentioned staggered arrangement.

[0643] Referring to Figures 51 to 55, in order to enhance the adaptive in-place matching effect of the blocking block, the present application divides the grid structure 161 (including the closed grid 1611 and the open grid 1612) into functional areas. Along the axial direction of the bracket, the grid structure 161 is specifically divided into a central area 1613 and edge areas 1614 on both sides of the central area. Different areas show different blocking effects after filling with the blocking block.

[0644] The shape of the blocking block can be a triangular pyramid, a quadrangular pyramid, an ellipse, a partial ellipse, a sphere, a partial sphere, a terrace, or other three-dimensional shapes, or a combination of multiple three-dimensional bodies. When formed by a mold, the mold cavity also has a corresponding shape.

[0645] For example, in Figures 51 and 54, along the axial direction of the stent (such as the Z direction in the figure), the thickness h1 of the blocking block 211 decreases from the middle area 1613 of the closed grid 1611 to the edge area 1614, and along the circumference of the stent, the width t1 of the blocking block 211 decreases from the middle area 1613 of the closed grid 1611 to the edge area 1614.

[0646] For example, as shown in Figures 51 and 55 , along the radial direction of the stent (e.g., the Z direction in the figures), the thickness h2 of the blocking block 212 decreases from the central region 1613 of the open grid 1612 to the edge region 1614. Along the circumference of the stent, the width t2 of the blocking block 212 decreases from the central region 1613 of the open grid 1612 to the edge region 1614. The maximum thickness of the blocking block is approximately 3 mm to 1 cm.

[0647] These structural improvements to the thickness and width of the blocking blocks concentrate the material in the central region. This region of the blocking block within the grid structure 161 provides optimal deformation, further enhancing its ability to fill gaps. Furthermore, material accumulation is reduced in the edge regions. By leveraging the advantages of the staggered arrangement, the central regions of adjacent rings are completely offset, further reducing the preload force during crimping and the radial dimensions of the implant after crimping.

[0648] The block can be made of PU with a porous structure, with a porosity of 50-85%, for example, 60-80%, or 75%. When preparing the block, solid particles can be added to a polymer solution, which is then removed after curing to form a porous foam structure. The solid particles are generally water-soluble but not easily soluble in the polymer solution. (PU foam prepared using gas)

[0649] When removing solid particles, water washing can be used, which can be combined with vibration or kneading. There is no strict limit on the water washing temperature. In order to improve the washing effect, the washing temperature can be between 30-60.

[0650] The solid particles have a particle size of approximately 5-500 μm, for example, 5-250 μm, and are sodium chloride, potassium chloride, or sugar. The corresponding pore size is approximately 5-200 μm. By adjusting the gradation of the fixed particles and the particle size, uniform or variable pore size can be achieved. The polymer solution concentration can be 0.5%-20.0% (w / v), for example, 5.0%-15.0% (w / v). When using polyurethane raw materials, the solvent can be DMSO, etc.

[0651] Due to its porous structure, the resulting occlusion block exhibits excellent elasticity and elongation, adapting to the in vivo environment to ensure effective occlusion. It also facilitates compressed loading and intravascular insertion. Compared to its compressed state, the volume after free expansion can reach 2 to 30 times, for example, 3 to 20 times, or at least 5 times.

[0652] Regarding the position and number of the pull wires connected to the blocking blocks, these factors will affect the connection strength and positioning effect of the blocking blocks. Some improvement methods are provided below.

[0653] 56 to 60 , along the radial direction of the stent (ie, along the X direction in FIG. 56 ), the peripheral leakage prevention device 2 has an inner side 2 a and an outer side 2 b opposite to each other, and the pull wire 22 is located close to the inner side 2 a .

[0654] After the blocking blocks and pulling wires of the same circle layer are sewn to the bracket, from the overall structure, the pulling wire 22 is located on the inner side of the bracket 162 and can even be attached to the grid structure, which is convenient for sewing. The blocking block 21 protrudes from the outer peripheral surface of the bracket 21, forming the above-mentioned protruding area 21a and non-protruding area 21b.

[0655] The anti-peripheral leakage device 2 has a curled state wrapped around the bracket 21 and a relatively straight state. The curled state can be understood as the annular form of the anti-peripheral leakage device 2 sewn on the cylindrical bracket (as shown in Figure 56), and the straightened state can be understood as the straight chain form when not sewn (as shown in Figure 58), and can also be understood as the direct form of the anti-peripheral leakage device after the raw materials are solidified and formed, and multiple pulling lines are arranged according to their own extension directions.

[0656] Among the multiple pulling wires mentioned above, each pulling wire corresponds to at least one circle of blocking ring. As shown in Figure 58, the pulling wire 22a corresponds to one circle of blocking block ring 24a, the pulling wire 22b corresponds to two circles of blocking block ring 24, and the pulling wire 22c corresponds to the blocking block ring 24b and the blocking block ring 25.

[0657] To enhance circumferential positioning and ensure the staggered positioning, at least one pull line passes through all the blocking blocks in two adjacent circles. When the blocking blocks are arranged in multiple circles, each circle is arranged axially along the stent, and at least one pull line passes through all the blocking blocks in one circle, such as the pull lines 22b and 22c shown in the figure, which pass through all the blocking blocks in two adjacent circles. This not only ensures the positioning of the blocking blocks in the same circle, but also further ensures the positioning of the blocking blocks in adjacent circles arranged in a staggered manner.

[0658] As shown in Figure 59, multiple puller wires can be arranged in parallel or staggered. The puller wires can be arranged along the circumference and axial direction of the stent, which fully position the blocking blocks on the adjacent layers of the staggered arrangement. As shown in the figure, along the circumference of the stent, puller wires 22a and 22b pass through all the blocking blocks in the same layer, and the two are parallel to each other; along the axial direction of the stent, puller wires 22e and 22d pass through adjacent blocking blocks in adjacent layers. In the three adjacent blocking block rings (blocking block ring 24a, blocking block ring 24b, blocking block ring 25), puller wire 22d passes through the axially adjacent blocking blocks 211b, blocking block 211a, and blocking block 212a, and puller wire 22d partially intersects with puller wires 22a, 22b, and 22c.

[0659] Among them, for the pulling lines arranged in parallel in the same circle layer, at least one pulling line extends along the length direction of the anti-peripheral leakage device, and the length direction of the anti-peripheral leakage device 2 also corresponds to the circumferential direction of the bracket in the curled state (along the Y direction in the figure), that is, from the perspective of the straightened state, the blocking block ring 24a is straightened along the Y direction in the figure (that is, the length direction of the anti-peripheral leakage device 2), and the pulling line 22a and the pulling line 22b both extend along the Y direction in the figure; for the blocking block ring 25, only one pulling line 22c extends along the Y direction in the figure.

[0660] In the scenario of multi-layer arrangement, at least two pulling lines extend along the length direction of the anti-leakage device in the straight state, the blocking block ring 24a and the blocking block ring 24b are both straightened along the Y direction in the figure, and the pulling lines 22a, 22b, and 22c also extend along the Y direction in the figure.

[0661] Regardless of whether it is a blocking block in a closed grid or a blocking block in an open grid, the pull wires connected thereto can be one group or more than two groups, each group consisting of multiple parallel wires, one group extending along the length direction Y of the anti-leakage device, and the other group extending along the width direction of the anti-leakage device (corresponding to the axial direction of the stent, i.e., the Z direction as shown in FIG59 ). For example, the blocking block 212a in the figure is provided with two groups of pull wires, one group consisting of pull wires 22c extending along the Y direction, and one group consisting of pull wires 22e and 22d extending along the Z direction. The blocking block 211b is also provided with two groups of pull wires, one group consisting of pull wires 22a and 22b extending along the Y direction, and one group consisting of pull wires 22e and 22d extending along the Z direction.

[0662] The pulling wires in different extending directions belong to the same wire and are wound around each other. For example, as shown in FIG60 , the pulling wire 22 a extending along the Y direction and the pulling wire 22 d extending along the Z direction may be composed of the same pulling wire.

[0663] Since the thickness and width of the blocking block increase from the edge area to the middle area, the material of the blocking block itself is concentrated in the middle area. The connection position and connection method between the pull wire and the blocking block directly affect the final positioning effect. Therefore, some improvements to the connection position and connection method between the pull wire and the blocking block are provided below.

[0664] Referring to Figures 61 and 62, the blocking blocks are arranged in one or more circles corresponding to the grid structure, and at least two pull lines pass through the same circle of blocking blocks and extend along the length of the anti-leakage device in the straightened state. As shown in the figure, when only blocking block 211 is arranged in one circle, two pull lines (pull line 22a and pull line 22b) pass through the edge areas of all blocking blocks 212. When blocking blocks 211 and 212 are arranged in two circles, at least two pull lines can be set to pass through the edge areas of all blocking blocks 212, of which one pull line 22c passes through the edge areas of all blocking blocks 211 and 212.

[0665] Preferably, referring to Figure 63, when the blocking blocks 211 and 212 are arranged in two circles, along the width direction of the anti-leakage device in the straight state, among the pulling lines passing through the blocking blocks in the same circle, there is at least one pulling line adjacent to the middle area of ​​the blocking block, such as the two pulling lines in the figure, among which the pulling line 22b passes through the middle area of ​​the blocking block 211, and along the width direction of the blocking block (that is, along the Y direction in the figure), the overlapping length L1 of the pulling line 22b and the blocking block 211 accounts for 1 / 3-2 / 3 of the maximum width L2 of the blocking block 211. This connection position can avoid the area with the greatest deformation on the blocking block, avoid the problem of incompatibility at the connection of the pulling line after the blocking block is deformed, and take into account the connection strength.

[0666] Referring to Figure 64 , a limiting component is fixed to the puller wire and embedded in the blocking block. The limiting component can be in the form of a knot 221. The limiting component can be embedded in the blocking block before it solidifies, thereby achieving a good embedding effect after the blocking block is fully solidified, preventing the blocking block from shifting when it is stressed on the smooth puller wire.

[0667] The limiting component can also be provided with a circuitous structure 222 connected to the knot 221 to further ensure the limiting effect. When multiple pull lines are provided, each pull line is connected by the limiting component to form a connected whole.

[0668] The pulling wire can be made of materials such as nylon and PTFE.

[0669] 65 and 66 , in another embodiment, the anti-circumferential leakage device 2 further includes an inner lining film 26 . In the curled state, the inner lining film 26 is on the inner side, and each blocking block is fixed on the outer side of the inner lining film 26 .

[0670] In other embodiments, only the lining film 26 may be provided without the pull wire. A spacing portion 241 is provided between two adjacent blocking blocks in the same circle, and a portion of the pull wire 22a is located in the spacing portion along its own extension path, and the portion is fixedly attached to the lining film 26 .

[0671] Most existing lining membranes are made of PET. Although they basically meet performance requirements, they are very expensive and have low elasticity. When suturing to the stent, the needle holes are large and the inner edge stress is high, making it difficult to self-close. When the artificial implant is radially compressed and loaded, local bending and stacking may cause the PET lining membrane to crack. In addition, the deformation of the stent grid may also pull the PET membrane to tear.

[0672] The material of the lining membrane may include, but is not limited to, the following biocompatible and biostable materials, such as PET, silicone, polyurethane (PU), PEEK, PTFE, nylon, PP, PE (LD / HDPE), polyamide, polyester, ultra-high molecular weight polyethylene (UHMWPE), silicone, polyoxymethylene, polyphenylsulfone, polysulfone, polyvinylidene fluoride, etc. Preferably, the lining membrane and the blocking block of this embodiment are made of the same material, for example, both are made of PU. In general, they are all PU, but the specific physical and chemical properties may be different, such as the specific soft segment to hard segment ratio, elastic modulus, porosity, etc. In addition, the same raw materials may be used, that is, the specific physical and chemical properties are also the same. The thickness of the lining membrane is 0.1 to 0.5 mm, for example, 0.15 to 0.4 mm, and for example 0.2 to 0.3 mm. Preferably, the lining membrane 26 is made of non-foamed PU material.

[0673] After the sealing block and the lining membrane are processed separately, they can be combined by using a bonding process, for example, forming a bonding layer by an adhesive.

[0674] 67 to 68 , an embodiment of the present application further provides an artificial implant 16, comprising a stent 162 and a peripheral leakage prevention device 2 wrapped around the stent 162, wherein the stent 162 is cylindrical and has a grid structure 161. The grid structure can be understood as a cylindrical sidewall with a hollow area, and the edge of the hollow area is a frame bar that forms a grid. There is no strict limitation on the size and specific shape of the grid. In the axial direction of the stent, the stent has an inflow side 1621 and an outflow side 1622 according to the normal blood flow direction in the body. The stent can be manufactured using the processing method described above.

[0675] The circumferential leakage prevention device 2 is placed around the inflow side 1621 of the stent and primarily comprises a blocking block 21 and a pull wire 22. Multiple blocking blocks 21 are arranged circumferentially around the artificial implant 16. Each block utilizes a deformable structure and is embedded in a corresponding grid structure. The blocks are interconnected by pull wires 22 to form one or more rings of blocking blocks. Furthermore, after the blocks are embedded in the grid structure 161, at least a portion of the blocking block 21 protrudes radially beyond the stent, representing a protruding region 21a.

[0676] When the artificial implant 16 is in place in the body and the gripping force is removed, the blocking block 21 fully expands and deforms due to its own elasticity or loose porous structure. The protruding area 21a of the blocking block is squeezed against the surrounding tissue and can produce an adaptive positioning matching effect, thereby circumferentially matching the gap between the stent and the native valve, solving the problem of peripheral leakage of the artificial heart valve.

[0677] Some embodiments below also provide methods for processing artificial implants, which are used to process the artificial implants described above.

[0678] An embodiment of the present application provides a method for processing an artificial implant, wherein the stent 162 used is cylindrical and has a grid structure 161, and the anti-peripheral leakage device 2 used includes a blocking block 21 and a pull line 22, wherein the blocking blocks 21 are arranged in a plurality of pieces along the circumference of the artificial implant, each blocking block adopts a deformable structure, and each blocking block is connected to each other by a pull line. The stent and anti-peripheral leakage device mentioned in this embodiment can be combined with the above embodiments.

[0679] 69 to 71 , the processing method of this embodiment includes the following steps:

[0680] A1: Provide the aforementioned stent 162 and the peripheral leakage prevention device 2. The stent 162 is now in an expanded state, and the blocking blocks 21 are connected by pull wires 22 to form a long chain-like peripheral leakage prevention device.

[0681] A2: The anti-circular leakage device 2 is then rolled up and connected end to end in a rolled state, and each blocking block is connected by a pulling line to form a blocking block ring (such as the blocking block ring 24 and the blocking block ring 25 in the figure);

[0682] A3: Fix the curled anti-leakage device 2 to the bracket 162, and when fixing, each blocking block is embedded in the grid structure corresponding to the position.

[0683] If the anti-circumferential leakage device is composed of multiple layers of blocking block rings, the multiple layers of blocking block rings can also be connected by multiple groups of pulling lines in parallel arrangement and intersecting arrangement to form a complete blocking block network.

[0684] Some embodiments below provide another method for processing an artificial implant, which is used to process the artificial implant described above.

[0685] An embodiment of the present application provides a method for processing an artificial implant, wherein the stent 162 used is cylindrical and has a grid structure 161, and the anti-peripheral leakage device 2 used includes a blocking block 21 and a pull line 22, wherein the blocking blocks 21 are arranged in a plurality of pieces along the circumference of the artificial implant, each blocking block adopts a deformable structure, and each blocking block is connected to each other by a pull line. The stent and anti-peripheral leakage device mentioned in this embodiment can be combined with the above embodiments.

[0686] 72 to 74 , the processing method of this embodiment includes the following steps:

[0687] B1: Provide the aforementioned stent 162 and the peripheral leakage prevention device 2. At this time, the stent 162 is in an expanded state, and the blocking blocks 21 are connected by the pull wires 22 to form a long chain of blocking block strips 28.

[0688] B2: Place a portion of the length of the anti-leakage device 2 inside or outside the bracket and fix it to the bracket 162;

[0689] B3: Gradually fix the remaining parts of the anti-circular leakage device 2 to the bracket 162 until the anti-circular leakage device 2 is connected end to end in a curled state, and when fixed, each blocking block is embedded in the grid structure corresponding to the position.

[0690] The processing method of this embodiment can be better applied to stents of different radial sizes. The anti-circumferential leakage device is gradually embedded in the grid structure, making it easy to adjust the position of the blocking block.

[0691] Some of the following embodiments also provide a mold for forming an anti-circular leakage device, which is used to process the above anti-circular leakage device.

[0692] With reference to Figures 75 to 78, an embodiment of the present application provides a mold 8 for forming a peripheral leakage prevention device, comprising a body 81, one side of the body 81 being a working surface 811, on which a plurality of mold cavities 82 and wire grooves 83 are provided, wherein the plurality of mold cavities 82 are used to form blocking blocks, the shape of the mold cavities being made according to the specific shape of the grid structure of the bracket, the number of mold cavities being processed according to the number of grid structures on the inflow side of the bracket, the wire grooves 83 being used to thread pull lines, and the formed blocking blocks being connected by pull lines to form a peripheral leakage prevention device 2, so that the peripheral leakage prevention device 2 corresponds one-to-one to the network structure of the corresponding bracket, simplifying subsequent processing steps. The wire grooves can be arranged in a plurality of parallel or intersecting ways to facilitate the direct formation of a blocking block net or blocking block strips after the blocking block is solidified. The bracket, blocking block, pull line, blocking block net, and blocking block strips mentioned in this embodiment can be combined with the above embodiments.

[0693] Regarding the structure and layout of the wire trough, wire trough 83 opens onto the working surface 811 to facilitate the placement of pull wires. Wire trough 83 extends to the edge of the body 81, allowing the operator to remove all the blocks by pulling the pull wires after they have solidified. Wire trough 83 extends in a straight line, and its arrangement with the blocks aligns with the extended state of the peripheral leakage prevention device.

[0694] According to the above embodiment, a lining film can be provided in the anti-circular leakage device, and each blocking block is fixed to the outside of the lining film 26. In order to integrally mold the lining film, the mold 8 also includes a molding frame 84. The molding frame is provided on the working surface 811 and surrounds the outer periphery of the opening of the mold cavity 82. The molding frame needs to cover the entire working surface, so that all blocking blocks are connected via the lining film and the pull wire. In addition, a hollow area 841 is provided in the middle of the molding frame. This hollow area needs to expose the positions of all mold cavities so that the lining film at the final molding location can cover all blocking blocks.

[0695] The molding frame 84 and the body 81 can be of a separate structure or an integrated structure. Both mold structures are suitable for molding an anti-circular leakage device with an inner lining film. The following will improve the two mold structures.

[0696] For the split mold structure, the molding frame 84 can be stacked on the working surface 811, and the hollow area 841 in the middle of the molding frame exposes the positions of all mold cavities, so that after the lining film material and the blocking block material are solidified at the same time, all blocking blocks are connected to each other through the lining film and the pulling line.

[0697] For the integrated mold structure, referring to Figure 78, the molding frame 84 is the sunken area 842 of the working surface 811, and the mold cavity 82 and the wire groove 83 are also processed in the sunken area. In the subsequent molding process of the anti-leakage device, the sealing block raw material and the lining film raw material need to be filled in turn. At the same time, after curing, all the sealing blocks are connected to each other through the lining film and the pulling line.

[0698] Some embodiments below also provide a method for forming an anti-circumferential leakage device using a mold. The mold used includes a main body 81, one side of the main body 81 is a working surface 811, and a plurality of mold cavities 82 and wire grooves 83 are provided on the working surface 811. The mold itself can be a silicone mold, a Teflon mold, an aluminum mold, a stainless steel mold or a glass mold, and the mold can be prepared by 3D printing, traditional machining or casting.

[0699] The anti-circular leakage device can be specifically combined with the above embodiments. Referring to FIG. 79 , this embodiment includes the following steps:

[0700] C1: Add blocking block raw materials into the multiple mold cavities 82 of the mold 8. At this time, the blocking block raw materials still have a certain fluidity. The blocking block raw materials are preferably DMSO solution of PU, and the concentration can be 0.5%-20.0% (w / v). The PU solution can be formulated according to the actual performance requirements of the foam to obtain different elastic modulus, expansion coefficient, porosity and other parameters; the DMSO solution of PU contains solid particles with a particle size of about 5-500μm, such as 5-250μm sodium chloride.

[0701] C2: Lay the pulling wire 22, and the extension path of the pulling wire 22 intersects with the mold cavity 82, and the pulling wire can extend to the edge of the mold, that is, the extension direction of the pulling wire 22 is the arrangement direction of the mold cavity. If the pulling wire is provided with a knot for limiting, the knot is completely placed in the blocking block material in the mold cavity to form an embedding effect;

[0702] C3: Curing the blocking material under predetermined conditions, with a curing temperature of 10-60°C, for example, 20-50°C, or 30-40°C. Curing time is 1-24 hours, for example, 1.5-10 hours, or 2-4 hours. In this embodiment, curing is performed at 37°C for 2-4 hours, and the blocking material is cured and formed into a stable shape.

[0703] C4: Demolding the molded sealing blocks connected by pull cords to form the leak-proof device 2. Because the pull cords extend beyond the edge of the mold, all the sealing blocks can be removed by simply pulling them. The resulting porous structure can then be washed to remove solid particles.

[0704] In the above forming method, adding the blocking block material and laying the pulling wire can be performed in any order or alternately.

[0705] The material of the sealing block is fluid or paste-like, and is leveled or scraped to make it level with the working surface.

[0706] According to some of the above embodiments, the anti-circular leakage device further includes an inner lining membrane 26. In the curled state, the inner lining membrane 26 is located on the inner side, and the blocking blocks are fixed to the outer side of the inner lining membrane. To integrally form the anti-circular leakage device with the inner lining membrane, the mold 8 further includes a molding frame 84 for molding the inner lining membrane. The mold frame 84 and the body 81 can adopt a separate mold structure or an integral mold structure, which can be combined with the above embodiments.

[0707] Taking the split mold structure as an example, before solidifying the blocking block material, a lining film material is used to form a coating on the top side of the blocking block material. Then, the lining film material and the blocking block material are solidified simultaneously. The specific molding method also requires changing the above step C3 to the following steps:

[0708] C3-1: Cover the corresponding molding frame 84 on the main body 81 so that the mold cavity on the working surface corresponds to the hollow area of ​​the molding frame;

[0709] C3-2: Apply a non-foaming PU coating to the hollow area of ​​the combined mold;

[0710] C3-3: Curing as per step C3 above;

[0711] In the above step C2, the number of the pulling wires can be one or more evenly distributed on the blocking block material, and the arrangement of the pulling wires can be combined with the above embodiments.

[0712] With reference to Figures 80 to 81, some embodiments of the present application also provide an artificial implant for preventing circumferential leakage. The artificial implant has a grid structure and a cylindrical bracket 162. The anti-circumferential leakage device 2 includes a plurality of blocking blocks 21 and a lining membrane 26, wherein the plurality of blocking blocks are arranged along the circumference of the bracket, and each blocking block adopts a deformable structure and is embedded in a grid structure corresponding to the position. The plurality of blocking blocks are fixed to one side of the lining membrane. In a preferred embodiment, the lining membrane and the plurality of blocking blocks are made of the same material to enhance adhesion. Other specific features and processes can be combined with the above. In this embodiment, the pull wire is mainly omitted.

[0713] In one embodiment of the present application, an anti-paravalvular leakage skirt is provided. At least a portion of the anti-paravalvular leakage skirt has a flexible substrate, and at least a portion of the anti-paravalvular leakage skirt has a fabric-formed reinforcement component. The flexible substrate and the reinforcement component have an overlapping area.

[0714] The anti-valvular leakage skirt is made of a flexible sheet. The material of each area of ​​the sheet can be one of the following three situations:

[0715] a) Only has a flexible substrate;

[0716] b) having only reinforcement components;

[0717] c) It has both a flexible substrate and a reinforcing component.

[0718] The reinforcing component is used to increase the sewing strength of the anti-paravalvular leakage skirt. In the case of only a flexible base material, the flexible base material is easily torn after the suture passes through the flexible base material. By setting up the reinforcing component and utilizing the reinforcing component to bear the pulling force of the suture, the suture strength of the suture part of the anti-paravalvular leakage skirt can be increased, thereby preventing the force of the suture from damaging the anti-paravalvular leakage skirt.

[0719] The reinforcing components can be distributed continuously or dispersedly only in the parts that need to be sewn or in the parts where the sutures may pass through. The reinforcing components can be used to strengthen the areas near the pinholes caused by the sutures.

[0720] The area where the suture may pass through may be an area where the flexible substrate and the reinforcing component overlap, or may be an area where only the reinforcing component exists.

[0721] Referring to Figures 84 and 87 , the anti-paravalvular leakage skirt includes:

[0722] The flexible substrate 92 is a polyurethane film;

[0723] The reinforcing member 95 is in the form of fabric, and at least a portion of the reinforcing member and at least a portion of the flexible base material are overlapped and fixed to each other.

[0724] The anti-paravalvular leakage skirt no longer uses porcine pericardium material, but instead uses a thinner polyurethane membrane as the flexible base material. The reinforcing component is in the form of fabric. The reinforcing component will not significantly increase the thickness of the flexible base material, while effectively strengthening the suture area.

[0725] In the present application, the flexible substrate is fixedly connected to the reinforcing component as a formed sheet, or the flexible substrate is prepared on the reinforcing component by mold casting to achieve a fixed connection between the flexible substrate and the reinforcing component. It does not include the situation where a polyurethane solution is attached to the reinforcing component by coating, and the polyurethane solution forms a polyurethane film after curing.

[0726] The polyurethane film formed by applying is usually thin and it is difficult to control the uniformity of thickness. For this application, the flexible substrate is a component of the skirt. Although the thickness is also required to be thin, the thickness must also be uniform. Otherwise, the thinner parts are very likely to be damaged due to stress concentration. The anti-leakage skirt has an area with only a flexible substrate. The polyurethane film in this area must have a certain thickness and uniform thickness, which is difficult to achieve by applying, especially it is difficult to meet the thickness uniformity.

[0727] At least a portion of the reinforcing component extends out of the flexible substrate, that is, at least a portion of the reinforcing component is not overlapped and fixed with the flexible substrate. From another perspective, the portion of the reinforcing component extending out of the flexible substrate is neither fixed to the flexible substrate nor overlapped with the flexible substrate.

[0728] 88 and 89 , the anti-paravalvular leakage skirt 90 further includes a sealing component 91 fixed to a flexible substrate 92 , and the sealing component adopts a deformable structure.

[0729] In this application, the flexible substrate, occluding components and reinforcing parts are all made of medical-grade raw materials, such as polyurethane, etc. The anti-paravalvular leakage skirt has good biocompatibility and avoids thrombogenicity.

[0730] The elongation at break of the flexible substrate is not less than 200%. Optionally, the elongation at break of the flexible substrate is not less than 300%. Optionally, the elongation at break of the flexible substrate is 200% to 500%.

[0731] The tensile strength of the flexible substrate is 30 to 100 MPa. Preferably, the tensile strength of the flexible substrate is 40 to 100 MPa. Preferably, the tensile strength of the flexible substrate is 50 to 100 MPa. Preferably, the tensile strength of the flexible substrate is 50 to 90 MPa. Preferably, the tensile strength of the flexible substrate is 50 to 80 MPa.

[0732] The plugging component is polyurethane with an open pore structure.

[0733] The sealing component uses polyurethane with an open pore structure, which gives the material excellent compression rebound performance and a huge specific surface area. During the compression loading process, the sealing component can be compressed to a smaller size, which can reduce the overall delivery size.

[0734] Because the occluding component has an open pore structure, it absorbs blood and expands into any shape according to the physiological environment after being implanted in the body. The internal pores of the occluding component also provide a place for cell adhesion, which helps tissue regeneration.

[0735] By controlling the pore structure in the occluding component, combining multidisciplinary technical principles such as mechanics, bionics, and finite element analysis, the force distribution of the occluding component is analyzed to optimize the component structure design. By regulating the pore structure and size in the occluding component to meet the acceptable standards of tensile strength, compression, and bonding strength, while being beneficial to cell attachment and tissue growth, and promoting the fit between the skirt and the paravalvular tissue, an anti-paravalvular leakage skirt with good mechanical properties and biocompatibility that meets the requirements of composite implantability can be prepared, thereby realizing the active anti-paravalvular leakage function.

[0736] The sealing component and the flexible substrate are made of the same polyurethane.

[0737] The polyurethane used in the occluding component and flexible substrate must possess excellent mechanical properties, biostability, hemocompatibility, and resistance to environmental stress tearing, ensuring safety for long-term cardiovascular implantation. The occluding component and flexible substrate utilize the same polyurethane, differing only in that the flexible substrate is directly formed from the polyurethane film, while the occluding component has a porous structure.

[0738] Both the occluding component and the flexible substrate are made of implantable polyurethane materials, including but not limited to Elast-Eon, LifePolymer, POSS-PCU and Chronosil.

[0739] The pores in the plugging component are interconnected and have uniform pore size. The relatively uniform pore size and interconnected pores in the plugging component give the plugging component excellent compression rebound performance and a large specific surface area.

[0740] The porosity of the plugging component is 50-95%, for example, 60-95%, or 70-90%.

[0741] The porosity of the plugging component determines the compression and rebound performance of the plugging component to a certain extent. The higher the porosity, the better the compression performance, but it may reduce the rebound and strength. The appropriate porosity can take into account all aspects of performance and ensure appropriate compressibility, rebound and strength.

[0742] The fabric is a flexible fabric. Although the fabric is used as a reinforcing component, it still needs to have good flexibility. At least after the reinforcing component is combined with the flexible substrate, the flexibility of the flexible substrate will not be significantly reduced.

[0743] The fabric thickness range is 0.04mm to 0.2mm, and the fabric hole size is not less than 0.03mm*0.03mm. Use a 0.4mm diameter needle and PTFE suture thread, and thread the needle 5mm from the fabric edge. The measured suture force value is not less than 2.5N.

[0744] The raw material of the fabric is one of polyester (PET), polyamide (PA), and polyetheretherketone (PEEK). For example, the raw material of the fabric is polyester. The fabric can be a woven fabric with a weft knitted structure.

[0745] The anti-paravalvular leakage skirt has an inflow end and an outflow end relative to each other according to the expected blood flow direction under a physiological environment, and the portion of the reinforcing component extending out of the flexible substrate is located at the outflow end.

[0746] The part of the reinforcing component extending out of the flexible substrate is located at the outflow end, that is, the part of the reinforcing component extending out of the flexible substrate is between the inflow end and the outflow end, closer to the outflow end. The reinforcing component is located at the outflow end. The outflow end is mainly used to be fixed on the bracket after being sutured with the leaflet. The reinforcing component is mainly used to increase the suture strength.

[0747] The blocking component is located at the inflow end of the anti-paravalvular leakage skirt, that is, the blocking component is between the inflow end and the outflow end, closer to the inflow end.

[0748] In the axial direction of the anti-paravalvular leakage skirt, there is a distance between the occluding component and the reinforcing component. The distance between the occluding component and the reinforcing component is 3 to 20 mm. More preferably, the distance between the occluding component and the reinforcing component is 10 to 15 mm.

[0749] Because both the blocking component and the reinforcement member are irregularly shaped, the distance D is defined as shown in Figures 88 and 89 . In the axial direction of the stent, the distance D between the blocking component 130 and the reinforcement member 120 at their closest locations is 3 to 20 mm. More preferably, the distance between the blocking component and the reinforcement member is 10 to 15 mm.

[0750] The blocking component and the reinforcing component are located in different areas of the flexible substrate, and the blocking component and the reinforcing component do not contact each other and do not affect each other.

[0751] The blocking component and the reinforcing component are located on the same side of the flexible substrate, or on different sides of the flexible substrate. When the flexible substrate is laid flat, it has two opposite sides, and the blocking component and the reinforcing component are located on the same side or on different sides of the flexible substrate.

[0752] The flexible substrate has a first edge and a second edge opposite to each other, the first edge corresponding to the inflow end of the anti-paravalvular leakage skirt, the second edge being used for being fixed to the stent after being sutured with the valve leaflet, and the second edge being closer to the outflow end of the stent than the first edge;

[0753] The reinforcing component has a third edge and a fourth edge opposite to each other, and the fourth edge of the reinforcing component has the same shape as the second edge of the flexible substrate.

[0754] As shown in FIG82 , flexible substrate 92 has a first edge 921 and a second edge 922. Under physiological conditions, first edge 921 is positioned adjacent to the inflow end of the stent, while second edge 922 is positioned adjacent to the outflow end. Second edge 922 has a curved portion adapted to the shape of the stent. Second edge 922 is sutured to the leaflets and secured to the stent. The shape of the flexible substrate is not limited to that shown in FIG82 ; its specific shape varies depending on the stent type. FIG82 primarily illustrates the relative positional relationship between the first and second edges.

[0755] As shown in Figures 83 and 86 , the reinforcing member 200 has a third edge 951 and a fourth edge 952. The shape of the fourth edge 952 of the reinforcing member is the same as the shape of the second edge 922 of the flexible substrate 92. The shape of the reinforcing member is not limited to that shown in Figures 83 and 86 ; the specific shape can be selected as needed. Figures 83 and 86 mainly distinguish the relative positional relationship between the third edge and the fourth edge.

[0756] The third edge and the fourth edge of the reinforcing component have the same shape. The reinforcing component is substantially wavy and has the same width at all locations.

[0757] As shown in FIG83 , the reinforcing component 95 is generally wavy in shape, and the width W is the same everywhere. This is intended to describe the general shape and is not a strict limitation, especially in the region where the reinforcing component has a turning point, where the width may vary.

[0758] The third edge of the reinforcing component is a smooth arc.

[0759] As shown in Figure 86, the third edge 951 of the reinforcing member 95 is a smooth arc. When the third edge is in use, it is connected end to end to form a ring structure. When the third edge 951 of the reinforcing member 95 is an arc, the reinforcing member 95 has a larger area, which is easier to operate when fixed to the flexible substrate.

[0760] The fourth edge of the reinforcing component is flush with the second edge of the flexible substrate.

[0761] As shown in Figure 84, the second edge 922 of the flexible substrate 92 shown in Figure 82 and the fourth edge 122 of the reinforcing component 95 shown in Figure 83 are aligned and fixed to each other. The area where the reinforcing component 95 and the flexible substrate 92 overlap with each other (i.e., the area with a filling line in the figure) is used to thread the suture. Based on the presence of the reinforcing component, the strength of the flexible substrate can be increased to avoid being torn by the suture.

[0762] The flexible substrate has a first edge and a second edge opposite to each other, the second edge being closer to the outflow end of the stent than the first edge;

[0763] The reinforcing component has a third edge and a fourth edge opposite to each other, and the fourth edge of the reinforcing component extends beyond the second edge of the flexible substrate to form an extension for sewing.

[0764] As shown in Figure 87, the fourth edge 952 of the reinforcing component 95 exceeds the second edge 922 of the flexible substrate 92 to form an extension portion 953 (i.e., the area shown by the filled line in the figure), that is, the extension portion 953 only has the reinforcing component 95, and does not have the flexible substrate 92. The extension portion 953 is used to thread the suture. The extension portion 953 is only formed by the reinforcing component 95. On the one hand, it can reduce the size in the compressed state. On the other hand, the suture passes through the reinforcing component 95 instead of the flexible substrate. Sewing is easier, and there is no protrusion on the back after threading the needle, so the suture is not scratched and the durability of the valve is not affected.

[0765] The blocking component is at least one protrusion fixed on the flexible substrate, which can be blocking blocks arranged at intervals or a ring structure extending continuously in the circumferential direction.

[0766] Taking the bracket having a diamond grid as an example, as shown in Figures 88 and 89, the shape of the protrusion corresponds to the shape of the diamond grid of the bracket, and the protrusion can also adopt other shapes.

[0767] The reinforcing component and the flexible substrate are connected by at least one of solvent bonding, solution bonding, hot melt bonding, and sewing and splicing.

[0768] The solvent used in solvent bonding is a good solvent for polyurethane that is miscible with water.

[0769] The solvent used in the solvent bonding is at least one of dimethyl sulfoxide (DMSO), N,N-dimethylformamide (DMF), and N,N-dimethylacetamide (DMAC).

[0770] The solution bonding method uses a polyurethane solution having a concentration of 5 to 20 wt %. The solvent of the polyurethane solution is at least one of dimethyl sulfoxide (DMSO), N,N-dimethylformamide (DMF), and N,N-dimethylacetamide (DMAC). More preferably, the concentration of the polyurethane solution is 5 to 10 wt %.

[0771] When using a solution or solvent for bonding, it is preferred to use a syringe to apply the adhesive and then press with your fingers. You can also use a silicone rod, cotton swab or other tool to apply the adhesive. After the joints are completely soaked with the solvent or solution, dry them at a temperature of 50 to 70 degrees to complete the bonding.

[0772] The temperature of the hot melt bonding is 50-70°C and the heating time is 0.5-2 hours. More preferably, the temperature of the hot melt bonding is 50-70°C and the heating time is 1-2 hours.

[0773] The blocking component is connected to the flexible substrate via a bonding area, and the bonding area is formed by contact, penetration and solidification of the flexible substrate and the adjacent portion of the protrusion in the form of a solution.

[0774] The order of preparing the plugging component and the flexible substrate is not limited. The plugging component can be prepared first and then the flexible substrate, or the flexible substrate can be prepared first and then the plugging component.

[0775] The raw material for preparing the flexible substrate is a polyurethane solution, and the raw material for preparing the plugging component is a premix of solid particles and polyurethane solution. The raw materials of the flexible substrate and the plugging component both contain polyurethane solvent. If the flexible substrate is prepared first, then when the plugging component raw material comes into contact with the flexible substrate, the polyurethane solvent in the plugging component raw material will partially dissolve the flexible substrate, and then through curing, the plugging component is formed and the flexible substrate and the plugging component are bonded together. Similarly, if the plugging component is prepared first, then when the flexible substrate raw material comes into contact with the plugging component, the solvent in the flexible substrate raw material will also partially dissolve the plugging component, and then through curing, the flexible substrate is formed and the flexible substrate and the plugging component are bonded together.

[0776] The boundary of the bonding area is relatively fuzzy, but it can still be distinguished from the more uniform texture of flexible substrate 92 and plugging component 91. Unlike flexible substrate 92 and plugging component 91, the significant transition area between the flexible substrate and plugging component is the bonding area. Flexible substrate 92 and plugging component 91 can be already solidified or in solution form in a mold. The solutions in adjacent areas of flexible substrate 92 and plugging component 91 interpenetrate and solidify to form the bonding area.

[0777] The bonding area is located at the interface between the flexible substrate (or the polyurethane solution filled in the mold with the shape of the flexible substrate) and the sealing component (or the premix filled in the mold with the shape of the sealing component). Parts of the two themselves are contacted and penetrated through the solution, and a bonding area is obtained after solidification. Since they are both polyurethane materials, the bonding surface of the two will form a polyurethane bonding interface at the internal junction of the sealing component and the flexible substrate. However, this interface cannot form a clear and flat bonding interface because it is both polyurethane and the bonding is relatively sufficient. Instead, it is relatively fuzzy, uneven and completely combined together. At the same time, it shows that the formation of this interface has good bonding force and a stable bonding structure.

[0778] The thickness T1 of the flexible substrate is 0.03mm-0.05mm, the thickness T2 of the reinforcing component is 0.04-0.2mm, the thickness T3 of the overlapping and fixed portion of the flexible substrate and the reinforcing portion is 0.05-0.24mm, and T1, T2, and T3 meet the constraint: 0.05mm≥T1+T2-T3≥0.01mm.

[0779] The thickness of the flexible substrate is originally less than that of the porcine pericardium. When the flexible substrate is bonded to the reinforcing component, the flexible substrate is partially dissolved, and the polyurethane molecular chains in the flexible substrate are embedded in the pore structure of the fabric serving as the reinforcing component and solidified. By judging the thickness after the two are composited (i.e., bonded), it can be judged whether the composite is successful. If the thickness of the bonding portion between the reinforcing component and the flexible substrate is the sum of the thicknesses of the flexible substrate and the reinforcing component minus 0.01-0.05mm, it can be considered that the bonding between the two has reached an acceptable standard. The acceptable range of the thickness after the reinforcing component and the flexible substrate are bonded is 0.05-0.24mm.

[0780] In one embodiment of the present application, a method for preparing an anti-paravalvular leakage skirt is provided, comprising:

[0781] connecting the reinforcing component and the blocking component on the flexible substrate respectively;

[0782] Cut the reinforcement and the flexible substrate to the desired shape.

[0783] Connect the reinforcing component and the blocking component to the flexible substrate in any of the following order:

[0784] a) sequentially connecting a reinforcing component and a blocking component on a flexible substrate;

[0785] b) sequentially connecting the blocking component and the reinforcing component on the flexible substrate.

[0786] Cut the reinforcement and the flexible substrate to the desired shape in any of the following order:

[0787] 1) Before connecting the reinforcing component to the flexible substrate, the flexible substrate and the reinforcing component are cut separately;

[0788] 2) After the reinforcing component is connected to the flexible substrate, the flexible substrate and the reinforcing component are cut at the same time.

[0789] The preparation of the plugging component includes:

[0790] The polyurethane solution is mixed with solid particles to obtain a premix;

[0791] The premix is ​​solidified and washed to obtain a plugging component containing a pore structure.

[0792] The particle size of the solid particles is 80-120 meshes. The solid particles are insoluble in the solvent of the polyurethane solution but soluble in water. The pore structure can be obtained by removing the solid particles through water washing.

[0793] The particle size of the solid particles is relatively uniform, and the content of solid particles in the premix is ​​relatively high, forming a state similar to quicksand. The solid particles are in contact with each other and immersed in the polyurethane solution. Through solvent displacement molding / particle leaching method, a soft 3D porous framework structure with interconnected internal channels is obtained, giving the material excellent compression rebound performance and huge specific surface area.

[0794] In one embodiment of the present application, an artificial implant is further provided, comprising:

[0795] The stent is a deformable tubular structure with a hollow area on the side wall, and the interior of the stent is a blood flow channel;

[0796] The valve leaflets are connected to the stent to control the blood flow channel;

[0797] The anti-paravalvular leakage skirt of each embodiment of the present application is located inside the stent as a whole, the outflow end of the anti-paravalvular leakage skirt is connected to the valve leaflet, and the sealing component protrudes from the stent through the hollow area of ​​the stent.

[0798] The blocking component is located at the inflow end of the bracket, and the axial height of the blocking component corresponds to 1 to 2 rows of cells at the inflow end of the bracket.

[0799] After the anti-paravalvular leakage skirt is fixed on the stent, the axial height of the occluding component covers 1 to 2 rows of cells at the inflow end of the stent to ensure that the occluding component matches the position of the valve ring after implantation, so as to maximize the effect of preventing paravalvular leakage.

[0800] In one embodiment of the present application, a method for preparing an artificial implant is further provided, comprising:

[0801] Connecting the valve leaflet and the anti-paravalvular leakage skirt of each embodiment of the present application to form a cylindrical preform;

[0802] Assembling the preform to the scaffold of the artificial implant.

[0803] The following examples further illustrate the structural features of the anti-paravalvular leakage skirt and the process details of the preparation method.

[0804] Example 1

[0805] A method for preparing a paravalvular leakage prevention skirt comprises the following steps:

[0806] ① Prepare a PU solution (i.e. polyurethane solution, the solvent is dimethyl sulfoxide) with a concentration of 10.0wt% and preheat it to 60;

[0807] ② Spread the preheated PU solution flatly in a PU film forming mold, place it in a 60°C blast drying oven for 7 hours, and demold to obtain a PU film (i.e., a polyurethane film, also known as a flexible substrate);

[0808] ③ Mix the PU solution with 80-120 mesh sodium chloride in proportion (sodium chloride accounts for 75wt%) to prepare a premix;

[0809] ④ Fill the premix into the mold, scrape it flat and cover it with PU film. After curing and forming, the corresponding plugging component (hereinafter referred to as PU foam) is obtained. The plugging component is connected to the PU film to obtain a skirt;

[0810] ⑤ After the skirt is formed, cleaned and dried, it is cut into the shape shown in Figure 82 (the cutting shape is determined according to the shape of the different brackets);

[0811] ⑥ Cut the fabric according to Figure 83 (the fabric will be used as a reinforcement component after cutting. The shape of the fabric cut is determined by the shape of the bracket and the requirements of the reinforcement area);

[0812] ⑦ Lay the PU membrane with the plugging component attached on a glass plate (PU foam facing downward is preferred, PU foam facing upward is optional), cover the fabric on top of the PU membrane, and align the edge of the fabric with the top of the PU membrane (as shown in Figure 84), and apply dimethyl sulfoxide (DMSO) on the fabric for bonding;

[0813] ⑧ After the joint is completely infiltrated with DMSO, place the whole thing in a 60°C forced air drying oven and heat for 1 hour to obtain a skirt that prevents peripetal leakage.

[0814] Example 2: The fabric is first bonded to the flexible substrate and then cut

[0815] A method for preparing a paravalvular leakage prevention skirt comprises the following steps:

[0816] ① Prepare a PU solution (i.e. polyurethane solution, the solvent is dimethyl sulfoxide) with a concentration of 10.0wt% and preheat it to 60;

[0817] ② Spread the preheated PU solution flatly in a PU film forming mold, place it in a 60°C blast drying oven for 7 hours, and demold to obtain a PU film (i.e., a polyurethane film, also known as a flexible substrate);

[0818] ③ Mix the PU solution with 80-120 mesh sodium chloride in proportion (sodium chloride accounts for 75wt%) to prepare a premix;

[0819] ④ Fill the premix into the mold, scrape it flat and cover it with PU film. After curing and forming, the corresponding plugging component (hereinafter referred to as PU foam) is obtained. The plugging component is connected to the PU film to obtain a skirt;

[0820] ⑤ Lay the PU film connected to the plugging component flat on the glass plate (PU foam facing up or down), and the fabric should cover the position above the diamond-shaped foam by no less than 3mm;

[0821] ⑥ Apply dimethyl sulfoxide (DMSO) on the fabric. After the joint is completely soaked with DMSO, place the whole thing in a 60°C forced air drying oven and heat for 1 hour to bond the fabric to the polyurethane film.

[0822] ⑦ Cut ⑥ as a whole according to the drawing in Figure 82, that is, the shapes of the flexible substrate and the reinforcing component are exactly the same, and a spliced ​​fabric reinforced anti-petal leakage skirt is obtained.

[0823] Compared with Example 1, since bonding is performed before the fabric is cut in this embodiment, the fabric area is larger, the operation is simple, and the bonding success rate is high.

[0824] Example 3: Final preparation of the plugging assembly

[0825] A method for preparing a paravalvular leakage prevention skirt comprises the following steps:

[0826] ① Prepare a PU solution (i.e. polyurethane solution, the solvent is dimethyl sulfoxide) with a concentration of 10.0wt% and preheat it to 60;

[0827] ② Spread the preheated PU solution flatly in the PU film forming mold, place it in a 60°C forced air drying oven for 7 hours, and demold to obtain the PU film;

[0828] ③ Cut the PU film according to Figure 82 and set aside, and cut the fabric according to Figure 83;

[0829] ④ Lay the PU film flat on the glass plate, cover the fabric on top of the PU film, and align the edge of the fabric with the top of the PU film (as shown in Figure 84), and apply dimethyl sulfoxide (DMSO) on the fabric for bonding;

[0830] ⑤ After the joints are completely soaked with DMSO, the whole is placed in a 60°C forced air drying oven and heated for 1 hour to obtain a fabric-reinforced polyurethane film;

[0831] ⑥ Mix the PU solution with 80-120 mesh sodium chloride (sodium chloride accounts for 75wt%) in proportion to prepare a premix;

[0832] ⑦ Fill the premix for preparing the plugging component into the mold, scrape it flat and cover it with the fabric-reinforced polyurethane film prepared in step ⑤. After curing and molding, wash and dry it to obtain the anti-valvular leakage skirt.

[0833] In this embodiment, when bonding the fabric, the blocking component is not yet connected to the polyurethane film. Therefore, bonding the fabric and the polyurethane film is easy to operate, has a high bonding success rate, and does not damage the blocking component during the bonding process.

[0834] Example 4

[0835] A method for preparing a paravalvular leakage prevention skirt comprises the following steps:

[0836] ① Prepare a PU solution (i.e. polyurethane solution, the solvent is dimethyl sulfoxide) with a concentration of 10.0wt% and preheat it to 60;

[0837] ② Spread the preheated PU solution flatly in a PU film forming mold, place it in a 60°C blast drying oven for 7 hours, and demold to obtain a PU film (i.e., a polyurethane film, also known as a flexible substrate);

[0838] ③ Mix the PU solution with 80-120 mesh sodium chloride in proportion (sodium chloride accounts for 75wt%) to prepare a premix;

[0839] ④ Fill the premix into the mold, scrape it flat and cover it with PU film. After curing and forming, the corresponding plugging component (hereinafter referred to as PU foam) is obtained. Connect the plugging component to the PU film to obtain the skirt;

[0840] ⑤ After the skirt is formed, cleaned and dried, cut it according to Figure 85;

[0841] ⑥ Cut the fabric (PET fabric) according to Figure 86;

[0842] ⑦ Lay the cut PU film flat on the glass plate (PU foam facing up or down), cover the fabric on top of the PU film, and align the 1.5mm notches on the left and right sides (the notches on the left and right sides are set to align the fabric and PU film);

[0843] ⑧ Add an appropriate amount of DMSO on the fabric, press and fit it with your fingers or other tools, and after the joint is completely soaked with DMSO, put the whole into a 60°C forced air drying oven and heat it for 1 hour to obtain a skirt that prevents petal leakage.

[0844] In this embodiment, the area sutured with the leaflet is only PET fabric (width 1.5 mm), and the remaining sewing areas are only PU film. There is no need to thread the needle in the fabric reinforced area (i.e., the composite part of the PU film and PET fabric), so sewing is relatively easy, and there is no protrusion on the back after threading the needle, which does not scratch the suture and does not affect the durability of the valve.

[0845] Example 5

[0846] A method for preparing a paravalvular leakage prevention skirt comprises the following steps:

[0847] ① Prepare a PU solution (i.e. polyurethane solution, the solvent is dimethyl sulfoxide) with a concentration of 10.0wt% and preheat it to 60;

[0848] ② Spread the preheated PU solution flatly in a PU film forming mold, place it in a 60°C blast drying oven for 7 hours, and demold to obtain a PU film (i.e., a polyurethane film, also known as a flexible substrate);

[0849] ③ Cut the PU film according to Figure 85 and set aside, and cut the fabric (PET fabric) according to Figure 86;

[0850] ④ Lay the cut PU film flat on the glass plate, cover the fabric on top of the PU film, and align the 1.5mm gaps reserved on the left and right sides;

[0851] ⑤ Add an appropriate amount of DMSO on the fabric, press it with your fingers or other tools to fit it, and after the joint is completely soaked with DMSO, place the whole thing in a 60°C forced air drying oven and heat it for 1 hour to obtain a fabric-reinforced polyurethane film;

[0852] ⑥ Mix the PU solution with 80-120 mesh sodium chloride in proportion (sodium chloride accounts for 75wt%) to prepare a premix;

[0853] ⑦ Fill the premix for preparing the plugging component into the mold, scrape it flat and cover it with the fabric-reinforced polyurethane film prepared in step ⑤. After curing and molding, wash and dry it to obtain the anti-valvular leakage skirt.

[0854] In this embodiment, the area sutured with the leaflet is only PET fabric (width 1.5 mm), and the rest of the sewing area is only PU film. There is no need to thread the needle in the fabric reinforced area (the composite part of the PU film and PET fabric), so sewing is relatively easy, and there is no protrusion on the back after threading the needle, which does not scratch the suture and does not affect the durability of the valve.

[0855] In another embodiment, the leakage prevention skirt is not only located inside the stent, but at least a portion thereof can be folded to the outside of the stent through the inflow side of the stent and fixed to the stent.

[0856] For example, the flexible substrate is basically located inside the bracket, and the reinforcing component is basically located outside the bracket. The overlapping area of ​​the flexible substrate and the reinforcing component is roughly located on the inflow side of the bracket, for example, the overlapping area just wraps the end of the bracket.

[0857] Example 6

[0858] A method for preparing a paravalvular leakage prevention skirt comprises the following steps:

[0859] Prepare a 10.0 wt% PU solution (polyurethane solution, solvent is dimethyl sulfoxide) and preheat to 60

[0860] The preheated PU solution was spread flat on a PU film forming mold, placed in a 60°C forced air drying oven for 7 hours, and demolded to obtain a PU film (i.e., a polyurethane film, also a flexible substrate);

[0861] Cut the PU film as shown in Figure 82 and set aside; cut the fabric (PET fabric) as shown in Figure 90 and set aside;

[0862] The edges of the PU film and the fabric are bonded together, for example, using DMSO as the adhesive. Alternatively, a PU solution may be used as the adhesive, or the PU film and the fabric are bonded together by hot pressing or direct sewing to obtain a fabric-reinforced polyurethane film as shown in FIG91 .

[0863] The PU solution and 80-120 mesh sodium chloride are mixed in proportion (sodium chloride accounts for 75wt%) to prepare a premix;

[0864] The premix for preparing the plugging component is filled into the mold, and after being scraped flat, the above-mentioned fabric-reinforced polyurethane film is covered to carry out the skirt forming process. After cleaning and drying, the fabric-reinforced anti-valvular leakage skirt is obtained.

[0865] After the fabric-reinforced anti-paravalvular leakage skirt is connected to the stent of the artificial implant, the PU membrane is located on the inner side of the stent of the artificial implant, the sealing component faces outward and can protrude outward from the hollow part of the stent, and the fabric part is turned outward to the outside of the stent through the end of the stent and fixed on the stent. The PU membrane and the fabric form a pouch structure to wrap the sealing component, namely the PU foam material, inside.

[0866] In existing technology, the skirt is typically secured to the stent using sutures. These skirts are typically made of a fabric that is well-suited to these sutures, ensuring superior suture strength. However, this also increases the fabric's size and folding damage during retraction. Currently, to further enhance occlusion, some skirts incorporate deformable materials, such as foam, on the outside. However, interventional valve skirts face stringent requirements for material selection, making it difficult to balance the strength of the fabric itself, the strength of the deformable material, and the adhesion between the fabric and the deformable material.

[0867] Based on this, some embodiments of the present application also provide an adaptive anti-paravalvular leakage material. The adaptive anti-paravalvular leakage material can be directly installed on the bracket of the artificial implant, and can also be combined with the reinforcing components in the above embodiments for structural reinforcement to obtain the anti-paravalvular leakage skirt related to Figure 88 or Figure 89, which can be installed on the bracket of the artificial implant.

[0868] One embodiment of the present application provides an adaptive anti-paravalvular leakage material, which includes: a sheet-shaped and stretchable flexible substrate, and a sealing component attached to the flexible substrate, wherein the sealing component is one or more protrusions, each protrusion having a pore structure, and the flexible substrate and the protrusions are both made of polyurethane, and the connection between the flexible substrate and the protrusions is achieved by curing the polyurethane solution.

[0869] When applied to artificial implants such as artificial heart valves, the flexible substrate can serve as an outer skirt and / or an inner skirt, and the protrusion can serve as a blocking block with at least a portion protruding outward from the stent of the artificial heart valve.

[0870] The flexible substrate (serving as an inner lining membrane for fixed connection with the stent) and the raised portion (serving as a blocking block for blocking the gap between the valve and surrounding tissue) are made of the same polyurethane material. They can be solidified together in a liquid state, or they can be solidified separately and then bonded to the flexible substrate and raised portion using a polyurethane solution. At the joint, the flexible substrate and raised portion are brought into contact, penetrated, and solidified in solution to form a homogeneous material interface. Because the interface between the flexible substrate and the raised portion is made of both polyurethane materials, there is no obvious phase interface that could easily lead to delamination or peeling when subjected to external forces.

[0871] In the prior art, the stent covering material, including the anti-perivalvular leakage material, is usually connected to the stent by suturing, and the anti-paravalvular leakage material is usually in the form of a fabric. In the present application, the anti-paravalvular leakage material is not in the form of a fabric, and the flexible substrate and the protrusion are both prepared by casting. The flexible substrate and the protrusion are also made of the same polyurethane material, which has at least one of the following beneficial effects:

[0872] (a) In the prior art, once the protrusion falls off, it will wander in the blood vessels, which can easily lead to fatal problems such as thrombosis. In the present application, the protrusion and the flexible substrate are made of the same material, which has good compatibility and stronger interface bonding. There is no risk of the protrusion falling off, and the anti-paravalvular leakage material is safer to use.

[0873] (b) In the prior art, anti-paravalvular leakage materials are usually made of fabrics that are easier to sew, such as PET. However, PET is relatively hard, and during the deformation of the stent, the PET material has poor compliance and is prone to interference with the stent during the unfolding and folding of the PET folds, which can easily lead to damage to the leaflets or the membrane.

[0874] (c) The flexible substrate and the raised portion are made of the same polyurethane material and can be formed using the same process conditions, resulting in a simpler process flow and more convenient operation.

[0875] (d) The polyurethane material used for the flexible substrate and the protrusion has a large elongation at break and can adapt to the deformation of the stent. That is, during the deformation of the stent, the flexible substrate and the protrusion can adapt to their own deformation without causing any obstruction during the deformation of the stent and without affecting the compression and release of the stent.

[0876] (e) The protrusion has a porous structure. During the compression of the artificial valve, the protrusion can reduce the volume it occupies by squeezing the space within its own porous structure, minimizing the increase in the size of the delivery device access route. After being released in the body, the protrusion can restore the space within the porous structure and expand back to its initial size when no external force is applied, thereby achieving a good anti-valvular leakage effect. At the same time, it can form a better endothelial sealing effect when blood flushes the heart valve.

[0877] (f) In the prior art, when an adhesive is used to bond the various parts of the coating on the stent, the adhesive may be PET or other materials. The material of the adhesive is different from the material of the various parts of the coating. The interface formed by the bonding is relatively hard, causing the interface to become a stress concentration point. When the stent is compressed and loaded, the interface is likely to become the main force point, and the compliance deformation performance of the interface is poor. During the compression and expansion of the stent, obstruction is likely to occur, resulting in damage to the leaflet or the coating.

[0878] In the present application, both the flexible substrate and the protrusion are made of polyurethane. When the two are connected, the connection is also carried out through the solidification of the polyurethane solution itself. The adjacent parts of the flexible substrate and the protrusion are in contact in the form of solution. The solutions of the adjacent parts of the flexible substrate and the protrusion penetrate each other. In the later curing process, the solvent is mainly volatilized or dissolved and removed in the same curing method as the flexible substrate and the protrusion. The connection part of the flexible substrate and the protrusion forms a physical phase structure that is closer to the texture of the flexible substrate and the protrusion, ensuring the relative uniformity of the overall physical properties of the anti-leakage material. When the stent is pressed, loaded and released, the overall compliance of the anti-leakage material is good.

[0879] (g) In the prior art, sealing is generally achieved by passing adhesive material through the mesh of the skirt fabric to form a protrusion. Although the fabric has high strength during the connection between the two, it has poor elasticity and softness, and is easily torn and deformed when subjected to force. The integrated polyurethane material has better softness and resilience, and is more adaptable to the movement of the valve in the heart.

[0880] The elongation at break of the flexible substrate is not less than 200%. More preferably, the elongation at break of the flexible substrate is not less than 300%. More preferably, the elongation at break of the flexible substrate is 200% to 500%.

[0881] The pore size of the raised portion is 5 to 500 microns. Preferably, the pore size of the raised portion is 5 to 450 microns. Preferably, the pore size of the raised portion is 5 to 400 microns. Preferably, the pore size of the raised portion is 5 to 350 microns. Preferably, the pore size of the raised portion is 5 to 300 microns. Preferably, the pore size of the raised portion is 5 to 250 microns.

[0882] The raised portion has a controllable porosity. The raised portion has a uniform porosity. The raised portion has an adjustable porosity.

[0883] The porosity of the raised portion is 50 to 95%. Preferably, the porosity of the raised portion is 60 to 95%. Preferably, the porosity of the raised portion is 70 to 90%.

[0884] The protrusion has an open pore structure and / or a closed pore structure. Preferably, the protrusion has an open pore structure.

[0885] The average thickness of the flexible substrate is 0.02 to 0.20 mm. Preferably, the average thickness of the flexible substrate is 0.02 to 0.15 mm. Preferably, the average thickness of the flexible substrate is 0.02 to 0.12 mm.

[0886] The tensile strength of the flexible substrate is 30 to 100 MPa. Preferably, the tensile strength of the flexible substrate is 40 to 100 MPa. Preferably, the tensile strength of the flexible substrate is 50 to 100 MPa. Preferably, the tensile strength of the flexible substrate is 50 to 90 MPa. Preferably, the tensile strength of the flexible substrate is 50 to 80 MPa.

[0887] The flexible substrate is thinner and has higher tensile strength. It can deform arbitrarily with the bracket and is not easily damaged.

[0888] An embodiment of the present application also provides an adaptive anti-paravalvular leakage material, which includes: a sheet-shaped and stretchable flexible substrate, and one or more protrusions attached to the flexible substrate, each protrusion having a pore structure, and the flexible substrate and the protrusions are both made of polyurethane. The flexible substrate and the protrusions are connected by a bonding area, and the bonding area is formed by the contact, penetration, and solidification of the adjacent parts of the flexible substrate and the protrusions in the form of a solution.

[0889] As shown in Figures 97 and 98 , the thickness d of the bonding area is 0.01 to 0.03 mm. As shown in Figure 97 , the boundary of the bonding area is relatively fuzzy, but it can still be distinguished from the more uniform texture of the flexible substrate 92 and the sealing component 91. The sealing component 91 is a raised portion, or is different from the flexible substrate 92 and the raised portion. The significant transition area between the flexible substrate and the raised portion is the bonding area. The flexible substrate 92 and the raised portion can be either already solidified or formed in the form of a solution in a mold. The solutions in adjacent areas of the flexible substrate 92 and the raised portion interpenetrate and solidify to form the bonding area.

[0890] The bonding area is located at the interface junction of the flexible substrate (or the casting material filled in the mold with the shape of the flexible substrate) and the protrusion (or the casting material filled in the mold with the shape of the protrusion). Parts of the two themselves are contacted and penetrated through the solution, and a bonding area is obtained after solidification. Since they are both polyurethane materials, the bonding surface of the two will form a polyurethane bonding interface at the junction of the protrusion and the inside of the flexible substrate. However, this interface cannot form a clear and flat bonding interface because it is both polyurethane and the bonding is relatively sufficient. Instead, it is relatively fuzzy, uneven and completely combined together, which also shows that the formation of this interface has good bonding force and a stable bonding structure.

[0891] An embodiment of the present application also provides an adaptive anti-paravalvular leakage material, which is made of polyurethane. The anti-paravalvular leakage material includes: a sheet-shaped and stretchable flexible substrate, one or more protrusions connected to the flexible substrate, and the flexible substrate and the protrusions are both molded using a casting process. The casting liquid of the protrusions is a polyurethane solution containing solid particles, and the casting liquid of the flexible substrate is a polyurethane solution or a polyurethane mixture containing solid particles.

[0892] The casting process involves filling a mold with casting liquid and then solidifying it into shape. The casting process is described in detail in the subsequent preparation process and will not be described in detail here.

[0893] The casting liquids of the protrusion and the flexible substrate are both polyurethane mixed liquids containing solid particles.

[0894] An embodiment of the present application also provides an adaptive anti-paravalvular leakage material, which includes a flexible substrate and a protrusion. The porosity of the protrusion is not lower than that of the flexible substrate. The interface between the flexible substrate and the protrusion is formed by contact, penetration, and solidification of the adjacent parts of the flexible substrate and the protrusion in the form of a solution.

[0895] The raised portion and the flexible substrate are made of the same material. The same material means that the physical and chemical properties of the material are the same. If the materials have different properties, they are considered to be different materials.

[0896] Both the raised part and the flexible base are made of polyurethane.

[0897] Both the protrusion and the flexible substrate have porous structures, and the porosity of the protrusion is not lower than that of the flexible substrate.

[0898] The protrusion has a porous structure, and the flexible substrate has a dense structure without pores.

[0899] One embodiment of the present application further provides a method for preparing an adaptive anti-paravalvular leakage material, which can be used to obtain the adaptive anti-paravalvular leakage material of each embodiment of the present application, wherein the preparation method comprises the following steps performed in any order:

[0900] The mold is filled with a polyurethane mixture containing solid particles, and after curing, the solid particles are washed away to obtain a protrusion;

[0901] The flexible substrate is obtained by solidifying and washing a polyurethane mixed liquid containing solid particles, and the connection between the flexible substrate and the protrusion is achieved by solidifying the polyurethane solution.

[0902] The protrusion and the flexible substrate are both made of the same polyurethane material, and the same process conditions can be used for curing the two. The process flow is simple, efficient, and easy to implement.

[0903] The protrusion and the flexible substrate can be manufactured one at a time and then the other, or both can be manufactured at the same time and formed into one piece.

[0904] The raised portion and the flexible substrate are made of the same polyurethane material. There is no obvious phase interface at the interface between the two, the bonding force is stronger, there is no risk of the raised portion falling off, and the safety is better.

[0905] The polyurethane mixed liquid is prepared by dispersing solid particles in a polyurethane solution. The polyurethane solution used to prepare the polyurethane mixed liquid and the polyurethane solution used to prepare the flexible substrate may be the same or different. In this application, the definition of the polyurethane solution applies to both the polyurethane solution used in the polyurethane mixed liquid and the polyurethane solution used to prepare the flexible substrate. Definitions of the polyurethane solution fixation conditions also apply to both the polyurethane solution used in the polyurethane mixed liquid and the polyurethane solution used to prepare the flexible substrate.

[0906] In this application, the polyurethane mixture contains a large amount of insoluble solid particles, causing the polyurethane mixture to exhibit a state similar to quicksand. When the polyurethane mixture contacts a polyurethane solution, the polyurethane solute and the polyurethane solvent in the polyurethane mixture form a solution (the solid particles in the polyurethane mixture have no effect on curing and are not considered), which then contacts, penetrates, and solidifies the polyurethane solution. The same understanding applies when a polyurethane mixture contacts another polyurethane mixture, i.e., the polyurethane solute and the polyurethane solvent in the polyurethane mixture form a solution (the solid particles in the polyurethane mixture have no effect on curing and are not considered), which then contacts, penetrates, and solidifies.

[0907] One embodiment of the present application further provides a method for preparing an adaptive anti-paravalvular leakage material, comprising the following steps:

[0908] Step 1, curing the polyurethane solution to obtain a flexible substrate;

[0909] Step 2, filling the mold with a polyurethane mixture containing solid particles;

[0910] Step 3: Cover the mold with a flexible substrate, contact the flexible substrate with a polyurethane mixture containing solid particles, solidify the polyurethane mixture containing solid particles, and wash away the solid particles to obtain an adaptive anti-paravalvular leakage material.

[0911] This method first prepares a flexible substrate, then creates raised portions on the flexible substrate. After the flexible substrate solidifies, it comes into contact with a polyurethane mixture. The surface of the flexible substrate in contact with the polyurethane mixture partially dissolves, and this dissolved portion solidifies along with the adjacent polyurethane mixture, forming a bonded area.

[0912] After the flexible substrate is cured, it contacts the polyurethane mixed liquid. After the polyurethane mixed liquid is cured, the flexible substrate and the protrusion are connected. The flexible substrate and the protrusion are made of the same material, and the interface bonding force between the two is better.

[0913] One embodiment of the present application further provides a method for preparing an adaptive anti-paravalvular leakage material, comprising the following steps:

[0914] Step 1: Filling a mold with a polyurethane mixture containing solid particles, curing the mixture, and washing to remove the solid particles to obtain a protrusion;

[0915] Step 2: contacting the protrusion with a polyurethane solution and curing the polyurethane solution to obtain an adaptive anti-paravalvular leakage material.

[0916] This method first creates a raised portion, then places a flexible substrate on the raised portion. After the raised portion solidifies, it comes into contact with a polyurethane solution. The surface of the raised portion in contact with the polyurethane solution partially dissolves, and this dissolved portion solidifies along with the adjacent polyurethane solution, forming a bonded area.

[0917] After solidification, the protrusion contacts the polyurethane solution. After solidification of the polyurethane solution, the flexible substrate and the protrusion are connected. The flexible substrate and the protrusion are made of the same material, and the interface bonding force between the two is better.

[0918] One embodiment of the present application further provides a method for preparing an adaptive anti-paravalvular leakage material, comprising the following steps:

[0919] Step 1, curing the polyurethane solution to obtain a flexible substrate;

[0920] Step 2: Filling the mold with a polyurethane mixture containing solid particles, and washing to remove the solid particles after curing to obtain a protrusion;

[0921] Step 3: bonding the flexible substrate and the protrusion with an adhesive to obtain an adaptive anti-paravalvular leakage material.

[0922] The binder is a polyurethane solution or a good solvent for polyurethane. The concentration of the polyurethane solution used as the binder is 8% to 14% (w / v).

[0923] The good solvent for the polyurethane used as the adhesive is at least one of dimethyl sulfoxide (DMSO), tetrahydrofuran (THF), dimethylformamide (DMF), dimethylacetamide (DMAc), dichloromethane, chloroform, and hexafluoroisopropanol (HFIP).

[0924] The solvent of the polyurethane solution used as an adhesive evaporates, bonding the flexible substrate and the protrusions together.

[0925] The good solvent of the polyurethane used for the adhesive evaporates, bonding the flexible substrate and the protrusion together. The good solvent partially dissolves the already solidified flexible substrate and the protrusion where they are in contact, reforming the polyurethane solution. The solvent of the polyurethane solution evaporates and then solidifies, connecting the flexible substrate and the protrusion together.

[0926] The preparation method comprises the following steps: firstly preparing a flexible substrate and a protrusion separately; then using a polyurethane solution or a good solvent of the polyurethane solution as an adhesive to bond the two together to obtain an adaptive anti-paravalvular leakage material.

[0927] The polyurethane solution or good solvent used as an adhesive dissolves the adjacent portions of the flexible substrate and the protrusions, that is, the portions where the flexible substrate and the protrusions are in contact with each other are dissolved by the adhesive and then solidified to form a bonding area.

[0928] One embodiment of the present application further provides a method for preparing an adaptive anti-paravalvular leakage material, comprising the following steps:

[0929] Step 1: Filling a mold with a polyurethane mixture containing solid particles;

[0930] Step 2: The polyurethane mixture containing solid particles is brought into contact with the polyurethane solution, solidified, and washed to remove the solid particles to obtain the adaptive anti-paravalvular leakage material.

[0931] This preparation method solidifies a polyurethane mixture and a polyurethane solution together to prepare an adaptive anti-paravalvular leakage material. The flexible substrate and the protrusion are both in solution form, and the two are solidified together to form a bonding area at their adjacent parts.

[0932] The flexible substrate and the raised portion are cured simultaneously and can be formed using the same process conditions, resulting in a simpler process and more convenient operation.

[0933] An embodiment of the present application further provides a method for preparing an adaptive anti-paravalvular leakage material, comprising:

[0934] Step 1: Filling a mold with a polyurethane mixed solution containing solid particles for forming the protrusions, and bringing the polyurethane solution for forming the protrusions into contact with a polyurethane solution for forming the flexible substrate;

[0935] Step 2: solidifying and washing to remove solid particles to obtain the adaptive anti-paravalvular leakage material.

[0936] The polyurethane mixture containing solid particles that forms the protrusion and the polyurethane mixture containing solid particles that forms the flexible substrate are solidified together to prepare an adaptive anti-paravalvular leakage material. The flexible substrate and the protrusion in the anti-paravalvular leakage material both have a porous structure.

[0937] The polyurethane molecular chain consists of hard segments and soft segments, with the soft segment accounting for 40-70% and the remainder being hard segments. The soft segment is at least one of polyether diol, polycarbonate diol, polyester diol, and polysiloxane diol, and the hard segment is an isocyanate with an R value of 1.0-1.1. The soft segment accounts for 50-65% of the polyurethane molecular chain.

[0938] The isocyanate is at least one of TDI, HDI, MDI, NDI, PPDI, IPDI, and XDI.

[0939] The polyurethane molecular chain also includes a chain extender, which is at least one of ethylene glycol, butanediol, hexanediol, octanediol, and ethylenediamine.

[0940] The solvent of the polyurethane solution is at least one of dimethyl sulfoxide (DMSO), tetrahydrofuran (THF), dimethylformamide (DMF), dimethylacetamide (DMAc), dichloromethane, chloroform, and hexafluoroisopropanol (HFIP).

[0941] The solvent of the polyurethane solution is selected to be easily volatile, easily soluble in water, and capable of dissolving polyurethane. The reason for being easily volatile is to facilitate the subsequent curing of the polyurethane by solvent evaporation under heating conditions, and the reason for being easily soluble in water is to allow the polyurethane to be formed after the solvent is dissolved in water.

[0942] The solvent of the polyurethane solution is two of dimethyl sulfoxide (DMSO), tetrahydrofuran (THF), dimethylformamide (DMF), dimethylacetamide (DMAc), dichloromethane, chloroform, and hexafluoroisopropanol (HFIP), and the volume ratio of the two solvents is 1 to 99:1. The volume ratio of the two solvents is 5 to 95:1. The volume ratio of the two solvents is 10 to 95:1. The volume ratio of the two solvents is 15 to 95:1. The volume ratio of the two solvents is 20 to 95:1. The volume ratio of the two solvents is 25 to 95:1. The volume ratio of the two solvents is 10 to 90:1. The volume ratio of the two solvents is 10 to 80:1. The volume ratio of the two solvents is 15 to 75:1. The volume ratio of the two solvents is 20 to 75:1. The volume ratio of the two solvents is 25 to 75:1.

[0943] The concentration of polyurethane in the polyurethane solution is 0.25% to 25% (w / v). Preferably, the concentration of polyurethane is 0.5% to 20% (w / v). Preferably, the concentration of polyurethane is 0.5% to 15% (w / v). Preferably, the concentration of polyurethane is 0.5% to 10% (w / v). Preferably, the concentration of polyurethane is 5% to 25% (w / v). Preferably, the concentration of polyurethane is 1% to 25% (w / v). Preferably, the concentration of polyurethane is 2% to 25% (w / v). Preferably, the concentration of polyurethane is 3% to 25% (w / v). Preferably, the concentration of polyurethane is 4% to 25% (w / v). Preferably, the concentration of polyurethane is 5% to 20% (w / v). Preferably, the concentration of polyurethane is 5% to 15% (w / v). Preferably, the concentration of polyurethane is 8% to 14% (w / v).

[0944] The solid particles are at least one of sodium chloride, potassium chloride and sucrose.

[0945] In the present application, the solid particles are insoluble in the polyurethane solution. When the polyurethane solution solidifies, the solid particles remain in a solid state. The solid particles are subsequently washed away with a detergent, and the space occupied by the solid particles forms a pore structure of the protrusion.

[0946] The solid particles are washed with a detergent, which can dissolve the solid particles, and the detergent is water.

[0947] To ensure uniform pore structure, a mixing device such as a multi-tube mixer is used to evenly disperse the solid particles in the polyurethane solution. The number average particle size of the solid particles is 5 to 500 microns. Preferably, the number average particle size of the solid particles is 5 to 450 microns. Preferably, the number average particle size of the solid particles is 5 to 400 microns. Preferably, the number average particle size of the solid particles is 5 to 350 microns. Preferably, the number average particle size of the solid particles is 5 to 300 microns. Preferably, the number average particle size of the solid particles is 5 to 250 microns.

[0948] The particle size of the solid particles determines the size of the pores in the protrusions. By adjusting the particle size of the solid particles, the size of the pores in the protrusions can be adjusted.

[0949] The mass fraction of solid particles in the polyurethane mixture determines the porosity of the protrusions, which in turn affects their strength. The greater the mass fraction of solid particles, the greater the porosity and the lower the strength of the protrusions. Therefore, the porosity, and thus the strength, of the protrusions can be adjusted by adjusting the mass fraction of solid particles in the polyurethane solution. Lower porosity increases protrusion strength. However, excessively low porosity will result in an excessively large volume after compression, making it difficult to load into a delivery device.

[0950] In the polyurethane mixture containing solid particles, the mass fraction of the solid particles is 50% to 80%. Preferably, the mass fraction of the solid particles is 55% to 80%. Preferably, the mass fraction of the solid particles is 60% to 80%. Preferably, the mass fraction of the solid particles is 60% to 75%.

[0951] The mold for the raised portion can be made of silicon, Teflon, aluminum, stainless steel, glass, etc. The mold material can be any material as long as it does not affect the molding of the polyurethane and has thermal conductivity. The specific structure of the mold is designed according to the requirements of the raised portion.

[0952] As shown in FIG. 99 , the mold 93 includes a plurality of mold cavities 94 , each mold cavity 94 corresponds to a protrusion, and the distribution of the mold cavities 94 is consistent with the distribution of the protrusions.

[0953] The shape of the mold cavity 94 is not limited. The mold has millimeter-level precision. The mold cavity 94 is shaped like at least one of a triangular pyramid, a quadrangular pyramid, an ellipse, a partial ellipse, a sphere, a partial sphere, a parallelogram, a rhombus, and a partial rhombus. Preferably, the shape of the mold cavity matches the shape of the protrusion.

[0954] The curing temperature of the protrusion and the flexible substrate is 20 to 90°C. Preferably, the curing temperature of the protrusion and the flexible substrate is 20 to 70°C. Preferably, the curing temperature of the protrusion and the flexible substrate is 20 to 50°C.

[0955] The curing time of the protrusion and the flexible substrate is not less than 4 hours. Preferably, the curing time of the protrusion and the flexible substrate is not less than 6 hours. Preferably, the curing time of the protrusion and the flexible substrate is not less than 12 hours.

[0956] The curing temperature of the protrusion and the flexible substrate is 20-90°C, and the curing time is at least 6 hours. Preferably, the curing temperature of the protrusion and the flexible substrate is 20-70°C, and the curing time is at least 6 hours. Preferably, the curing temperature of the protrusion and the flexible substrate is 20-50°C, and the curing time is at least 6 hours.

[0957] The curing temperature of the protrusion and the flexible substrate is 20-90°C, and the curing time is at least 12 hours. Preferably, the curing temperature of the protrusion and the flexible substrate is 20-70°C, and the curing time is at least 12 hours. Preferably, the curing temperature of the protrusion and the flexible substrate is 20-50°C, and the curing time is at least 12 hours.

[0958] The curing temperature of the protrusion and the flexible substrate is 50-70°C, and the curing time is 4-48 hours. Preferably, the curing temperature of the protrusion and the flexible substrate is 50-70°C, and the curing time is 4-24 hours.

[0959] The protrusions and the flexible substrate also include post-treatment after curing, and the post-treatment includes: placing the protrusions and the flexible substrate in 20-40 water for at least 2 hours.

[0960] In the post-processing step, the solvent of the polyurethane solution is dissolved in water, the polyurethane is insoluble in water, and the polyurethane is formed.

[0961] The post-processing comprises: placing the protrusion and the flexible substrate into 20-40 water for 2-4 hours.

[0962] The preparation of the protrusion and the flexible substrate also includes pre-curing before the curing step. The pre-curing conditions are: pre-curing temperature 20-70°C, pre-curing time 20-60 minutes.

[0963] The pre-curing conditions are: pre-curing temperature 30-60°C, pre-curing time 20-40 minutes.

[0964] When preparing the protrusions and the flexible substrate, pre-curing the polyurethane mixture containing solid particles can prevent the aqueous solution particles from floating in the polyurethane solution, resulting in uneven distribution of the solid particles in the polyurethane solution.

[0965] The pre-curing time is short. After the pre-curing treatment, the polyurethane mixture is not completely formed. This is mainly to prevent solid particles from floating in the polyurethane solution.

[0966] Washing the raised portions and the flexible substrate includes placing the raised portions in a detergent for at least 4 hours.

[0967] Washing the protrusions and the flexible substrate includes placing the protrusions in a detergent and leaving them to stand for 4 to 12 hours.

[0968] Washing the raised portions and the flexible substrate comprises subjecting the raised portions to a detergent treatment under agitation for at least 4 hours.

[0969] The washing of the protrusions and the flexible substrate comprises: placing the protrusions in a detergent in an agitated state for 4 to 12 hours.

[0970] The polyurethane solution in contact with the raised portion is at room temperature or has been preheated. Room temperature means no heating or cooling is performed. Preheating increases the temperature of the polyurethane solution, which improves its fluidity and facilitates handling. If room temperature already meets the fluidity requirements, preheating is not required.

[0971] The preheating temperature of the polyurethane solution is 30 to 70°C. Preferably, the preheating temperature of the polyurethane solution is 40 to 70°C. Preferably, the preheating temperature of the polyurethane solution is 50 to 70°C.

[0972] The preparation of the protrusion and the flexible substrate further includes a preliminary curing step before the pre-curing step. The preliminary curing can be performed in one of the following ways:

[0973] a) Blowing hot air on the surface of the polyurethane mixture containing solid particles;

[0974] b) spraying hot steam on the surface of the polyurethane mixture containing solid particles;

[0975] c) Add water, ethanol or isopropyl alcohol dropwise to the polyurethane mixture containing solid particles.

[0976] The main purpose of preliminary curing is to solidify the surface of the polyurethane mixture. The surface of the polyurethane mixture can be formed by volatilization of the solvent due to heat (such as blowing hot air or spraying hot steam), or it can be formed because the solvent of the polyurethane mixture is soluble in water, ethanol or isopropyl alcohol, while the polyurethane is insoluble in water, ethanol or isopropyl alcohol. The surface curing of the polyurethane mixture can prevent the floating of solid particles and break through the bonding surface between the protrusion and the flexible substrate.

[0977] In step a), the hot air temperature is 40-100°C, and the purge time is 0.5-2 min.

[0978] In step b), the steam temperature is 40-100°C, and the spraying time is 0.5-2 min.

[0979] In step c), 1 to 2.5 mL is added dropwise.

[0980] An embodiment of the present application further provides a valve (e.g., an artificial heart valve, specifically an artificial aortic valve, etc.), the valve comprising:

[0981] The stent has a blood flow channel inside, and the stent has an inflow side and an outflow side opposite to each other, and the inflow side has a grid structure;

[0982] One or more leaflets;

[0983] The anti-paravalvular leakage material is connected to the inflow side (on the inflow side relative to the leaflet), the flexible substrate of the anti-paravalvular leakage material is located inside the stent, and the protrusion is embedded in the grid structure; or the flexible substrate of the anti-paravalvular leakage material is located outside the stent, and the protrusion is located on the side of the flexible substrate facing away from the stent.

[0984] Both the flexible substrate and the protrusion are made of polyurethane. The interfacial bonding between the two is strong and has a large elongation at break. When the stent is deformed, the flexible substrate and the protrusion can adapt well to the deformation of the stent, shrinking as the stent shrinks and expanding as the stent expands. Even when the stent is deformed to the maximum extent, the flexible substrate and the protrusion can still maintain good mechanical properties.

[0985] The grid structure includes a plurality of cells, and the positions of the plurality of protrusions correspond to the cells one by one. When the flexible substrate is located inside the bracket, each protrusion extends from the inside to the outside of the bracket through the corresponding cell.

[0986] When the flexible substrate is located inside the stent, the protrusions extend from the inside to the outside of the stent through the corresponding cells, filling the paravalvular space. While achieving a good anti-perival leakage effect, there is no need to increase the thickness of the flexible substrate, avoiding increasing the access size of the delivery device. Even if the valve is recovered multiple times, it is not easy to be damaged.

[0987] When the anti-paravalvular leakage material is in a flattened state, each protrusion is parallel to a cross section of the flexible substrate and corresponds to a unit cell size.

[0988] Anti-paravalvular leakage materials can be used alone or in combination with other biological materials.

[0989] The following examples further illustrate the process details of the preparation method.

[0990] Example 7

[0991] A method for preparing an adaptive anti-paravalvular leakage material, as shown in FIG96 , comprises the following steps:

[0992] (1) Dissolve PU particles (i.e., polyurethane) in dimethylformamide (DMF) to obtain a polyurethane solution. The polyurethane content in the polyurethane solution is 15% (w / v).

[0993] (2) Sodium chloride particles are mixed with the polyurethane solution, and the sodium chloride solid particles are uniformly dispersed in the polyurethane solution using a multi-tube mixer. The diameter of the sodium chloride solid particles is about 100 to 200 microns, and the mass fraction of sodium chloride in the mixed solution is 75%. A premix for preparing the protrusions (i.e., a polyurethane mixed solution containing solid particles) is obtained.

[0994] (3) Fill the premix into a soft silicone mold and compact it.

[0995] (4) spreading the preheated polyurethane solution on the mold surface and defining the boundary of the polyurethane solution (the polyurethane solution is used to form a flexible substrate);

[0996] (5) Place the mold and the polyurethane solution spread on it in an oven and heat-set at 60°C for 4 hours, then take out the mold and cool it at room temperature.

[0997] (6) Place the cooled mold in water (use warm water, the temperature of the warm water can be between 25 and 40 degrees Celsius, and this temperature range can be used for warm water mentioned elsewhere) for 2 hours.

[0998] (7) The demoulded sample is placed in water (room temperature or warm water) to dissolve the sodium chloride solid particles (magnetic stirring is used to accelerate the dissolution of the sodium chloride solid particles) for 4 hours.

[0999] (8) Obtain an adaptive anti-paravalvular leakage material with a protrusion firmly bonded to a polyurethane flexible substrate.

[1000] Example 8

[1001] (1) Dissolve PU particles (i.e., polyurethane) in dimethylformamide (DMF) to obtain a polyurethane solution. The polyurethane content in the polyurethane solution is 15% (w / v).

[1002] (2) Mixing sucrose particles with the polyurethane solution, and using a multi-tube mixer to evenly disperse the sucrose solid particles in the polyurethane solution, wherein the diameter of the sucrose solid particles is about 300 to 500 microns, and the mass fraction of sucrose in the mixed solution is 75%, to obtain a premix for preparing the protrusions.

[1003] (3) Fill the premix into a soft silicone mold and compact it.

[1004] (4) Place the silicone mold in water (room temperature) and solidify for 1 hour, then dry at 60°C for 0.5 hour.

[1005] (5) removing the mold and spreading the preheated polyurethane solution on the surface of the mold to define the boundary of the polyurethane solution (the polyurethane solution is used to form the flexible substrate);

[1006] (6) Place the mold and polyurethane solution in an oven and heat-set them at 50°C for 3 hours, then take out the mold and cool it at room temperature.

[1007] (7) Place the cooled mold in water (warm water) for 2 hours.

[1008] (8) The demoulded sample is placed in water (room temperature or warm water) to dissolve the sucrose solid particles (magnetic stirring is used to accelerate the dissolution of the sucrose solid particles) for 2 hours.

[1009] (9) Obtain an adaptive anti-paravalvular leakage material with a protrusion firmly bonded to a polyurethane flexible substrate.

[1010] Example 9

[1011] (1) Dissolve PU particles (i.e., polyurethane) in dimethylacetamide (DMAc) to obtain a polyurethane solution. The polyurethane content in the polyurethane solution is 20% (w / v).

[1012] (2) Sodium chloride particles are mixed with the polyurethane solution, and the sodium chloride solid particles are uniformly dispersed in the polyurethane solution using a multi-tube mixer. The diameter of the sodium chloride solid particles is about 100 to 200 microns, and the mass fraction of sodium chloride in the mixed solution is 60%, thereby obtaining a premix for preparing the protrusions.

[1013] (3) Spread the polyurethane solution flat and dry it at 60°C for 12 hours to obtain a flexible substrate.

[1014] (4) Fill the premix into a soft silicone mold and compact it.

[1015] (5) Place the mold in water (room temperature) and dry and cure at 60°C for 1 hour.

[1016] (6) Remove the mold, add a small amount of preheated polyurethane solution (8% (w / v)) as an adhesive to the surface of the raised portion formed in the mold, and load the pre-prepared flexible substrate on its surface so that it can be firmly and effectively bonded.

[1017] (7) Place the mold in an oven and heat-set it at 50°C for 6 hours, then take it out and cool it at room temperature.

[1018] (9) The demoulded sample was placed in a magnetic stirrer filled with water (at room temperature) and stirred for 6 hours to dissolve the sodium chloride solid particles.

[1019] (10) An adaptive anti-paravalvular leakage material is obtained in which the protrusion is firmly bonded to the polyurethane flexible substrate.

[1020] Example 10

[1021] (1) Dissolve PU particles (i.e., polyurethane) in dimethylformamide (DMF) to obtain polyurethane solutions with polyurethane contents of 10% (w / v) and 20% (w / v).

[1022] (2) Potassium chloride particles are mixed with a 20% (w / v) polyurethane solution, and the potassium chloride solid particles are uniformly dispersed in the polyurethane solution using a multi-tube mixer. The diameter of the potassium chloride solid particles is about 50 to 150 μm, and the mass fraction of potassium chloride in the mixed solution is 75%, thereby obtaining a premix for preparing the protrusions.

[1023] (3) Fill the premix into the mold and compact it.

[1024] (4) Then, a preheated 10% (w / v) polyurethane solution (used to form a flexible substrate) is spread on the mold surface to define the boundary of the polyurethane solution.

[1025] (5) Place the mold in an oven and heat-set it at 50°C for 12 hours, then take it out and cool it at room temperature.

[1026] (6) The cooled mold was placed in a magnetic stirrer filled with water (room temperature) to accelerate the dissolution of the sodium chloride solid particles (magnetic stirring was used to accelerate the dissolution of the potassium chloride solid particles) for 12 hours, and then demolded.

[1027] (7) Obtain an adaptive anti-paravalvular leakage material with a protrusion firmly bonded to a polyurethane flexible substrate.

[1028] Example 11

[1029] (1) Dissolve PU particles (i.e., polyurethane) in dimethylformamide (DMF) to obtain a polyurethane solution. The polyurethane content in the polyurethane solution is 20% (w / v).

[1030] (2) Sodium chloride particles are mixed with the polyurethane solution, and the sodium chloride solid particles are evenly dispersed in the polyurethane solution using a multi-tube mixer. The diameter of the sodium chloride solid particles is about 300 to 400 microns, and the mass fraction of sodium chloride in the mixed solution is 65%, thereby obtaining a premix for preparing the protrusions.

[1031] (3) Fill the premix into a silicone mold and compact it.

[1032] (4) The surface of the silicone mold is subjected to hot air treatment for 3 minutes.

[1033] (5) Take out the mold and spread the preheated polyurethane solution (used to form the flexible substrate) on the surface of the mold to define the boundary of the polyurethane solution.

[1034] (6) Place the mold in an oven and heat-set it at 40°C for 2.5 hours, then take it out and cool it down at room temperature.

[1035] (7) Place the cooled mold in water (warm water) for 2 hours.

[1036] (8) The demoulded sample was placed in a magnetic stirrer filled with water (room temperature) to accelerate the dissolution of the sodium chloride solid particles for 12 hours.

[1037] (9) Obtain an adaptive anti-paravalvular leakage material with a protrusion firmly bonded to a polyurethane flexible substrate.

[1038] Example 12

[1039] (1) Dissolve PU particles (i.e., polyurethane) in dimethyl sulfoxide (DMAc) to obtain a polyurethane solution, wherein the polyurethane content in the polyurethane solution is 10% (w / v).

[1040] (2) Sodium chloride particles are mixed with the polyurethane solution, and the sodium chloride solid particles are evenly dispersed in the polyurethane solution using a multi-tube mixer. The diameter of the sodium chloride solid particles is about 100 to 200 microns, and the mass fraction of sodium chloride in the mixed solution is 75%, thereby obtaining a premix for preparing the protrusions.

[1041] (3) Fill the premix into the silicone mold (with grooves, which are also the mold cavities) and compact it.

[1042] (4) Spray hot steam on the surface of the silicone mold for 3 minutes.

[1043] (5) Take out the mold and spread the preheated polyurethane solution (used to form the flexible substrate) on the surface of the mold to define the boundary of the polyurethane solution.

[1044] (6) Place the mold in an oven and heat-set it at 60°C for 12 hours, then take it out and cool it at room temperature.

[1045] (7) Place the cooled mold in water (room temperature) for 6 hours.

[1046] (8) The demoulded sample was placed in a magnetic stirrer filled with water (room temperature) to accelerate the dissolution of the sodium chloride solid particles for 8 hours.

[1047] (9) Obtain an adaptive anti-paravalvular leakage material with a protrusion firmly bonded to a polyurethane flexible substrate.

[1048] Example 13

[1049] (1) Dissolve PU particles (i.e., polyurethane) in dimethylformamide (DMF) to obtain a polyurethane solution. The polyurethane content in the polyurethane solution is 12% (w / v).

[1050] (2) Mixing sucrose particles with the polyurethane solution, and using a multi-tube mixer to evenly disperse the sucrose solid particles in the polyurethane solution, wherein the diameter of the sucrose solid particles is about 100 to 200 microns, and the mass fraction of sucrose in the mixed solution is 50%, to obtain a premix for preparing the protrusions.

[1051] (3) Fill the premix into a silicone mold (with grooves) and compact it.

[1052] (4) Add 2.0 mL of ethanol to the surface of the silicone mold.

[1053] (5) Take out the mold and spread the preheated polyurethane solution (used to form the flexible substrate) on the surface of the mold to define the boundary of the polyurethane solution.

[1054] (6) Place the mold in an oven and heat-set it at 30°C for 12 hours, then take it out and cool it at room temperature.

[1055] (7) Place the cooled mold in water (warm water) for 2 hours.

[1056] (8) The demoulded sample is placed in water (room temperature or warm water) to dissolve the sucrose solid particles (magnetic stirring is used to accelerate the dissolution of the solid particles) for 4 hours.

[1057] (9) Obtain an adaptive anti-paravalvular leakage material with a protrusion firmly bonded to a polyurethane flexible substrate.

[1058] Example 14

[1059] (1) Dissolve PU particles (i.e., polyurethane) in dimethylformamide (DMF) to obtain a polyurethane solution. The polyurethane content in the polyurethane solution is 15% (w / v).

[1060] (2) Sodium chloride particles are mixed with the polyurethane solution, and the sodium chloride solid particles are evenly dispersed in the polyurethane solution using a multi-tube mixer. The diameter of the sodium chloride solid particles is about 400 to 500 microns, and the mass fraction of sodium chloride in the mixed solution is 75%, thereby obtaining a premix for preparing the protrusions.

[1061] (3) The polyurethane solution was dried at 60°C for 12 hours to obtain a flexible substrate.

[1062] (4) The premix is ​​filled into a soft silicone mold (with a predetermined groove shape) and compacted.

[1063] (5) Remove the mold and drip a low-concentration 8% (w / v) polyurethane solution (a small amount of polyurethane solution serves as an adhesive) onto the surface of the premix filled in the mold. At the same time, attach a pre-prepared flexible substrate so that the two are in full contact and bonded.

[1064] (6) Then put it into an oven and heat-set it at 55°C for 3.5 hours, then take it out of the oven and let it cool at room temperature.

[1065] (7) Place the cooled mold in water (normal temperature or warm water) for 2 hours.

[1066] (8) The demoulded sample is placed in water (room temperature or warm water) to dissolve the solid particles (magnetic stirring is used to accelerate the dissolution of the solid particles) for 4 hours.

[1067] (9) Obtain an adaptive anti-paravalvular leakage material with a protrusion firmly bonded to a polyurethane flexible substrate.

[1068] Comparative Example 1

[1069] (1) Dissolve PU particles (i.e., polyurethane) in dimethylformamide (DMF) to obtain a polyurethane solution. The polyurethane content in the polyurethane solution is 15% (w / v).

[1070] (2) Sodium chloride particles are mixed with the polyurethane solution, and the sodium chloride solid particles are uniformly dispersed in the polyurethane solution using a multi-tube mixer. The diameter of the sodium chloride solid particles is about 100 to 200 microns, and the mass fraction of sodium chloride in the mixed solution is 75%, thereby obtaining a premix for preparing the protrusions (i.e., a polyurethane solution containing solid particles).

[1071] (3) The premix is ​​filled into a grooved mold and compacted. Before covering the mold with PET fabric, a preheated polyurethane solution is applied as a binder in advance on the surface of the PET fabric and the added premix to allow them to fully contact and effectively bond the two together.

[1072] (4) Then dry at 60 for 30 minutes.

[1073] (5) Cool at room temperature for more than 20 minutes, and then place the mold in water for 36 hours or more before demolding.

[1074] (6) After demoulding, the skirt is placed in water (normal temperature or warm water) to dissolve the sodium chloride solid particles (magnetic stirring is used to accelerate the dissolution of the sodium chloride solid particles) for 4 hours.

[1075] (7) Obtaining a material for preventing paravalvular leakage.

[1076] Performance Characterization

[1077] As shown in Figure 92, Comparative Example 1 uses PET fabric as the base material and polyurethane solution as the adhesive to bond the PET fabric and the protrusion. Since PET and polyurethane are not the same materials, the compatibility between PET and polyurethane is not good, there is a significant physical interface, phase separation is easy to occur, the interface bonding force is poor, and the protrusion is easy to fall off from the base material. During the valve loading and recovery process, the risk of falling off is relatively high, posing a safety hazard.

[1078] As shown in FIG93 , the flexible substrate and the protrusion of Example 7 are both made of polyurethane. The interface bonding strength of the same material is better, there is no risk of the protrusion falling off, and safety is better.

[1079] As shown in Figure 94, the anti-paravalvular leakage material prepared in Comparative Example 1 uses PET fabric as the base material, and the PET fabric is bonded to the raised portion on the surface of the PET fabric using PU solution as an adhesive. In Figure 94, the upper half of the figure is an overall view of the anti-paravalvular leakage material, and the lower half of the figure is a local enlarged view of the area without the raised portion. It can be seen from Figure 94 that the surface of the anti-paravalvular leakage material is uneven, and the PU film is prone to warping and falling off.

[1080] Referring to Figure 95 , the anti-paravalvular leakage material prepared in Example 7, in Figure 95 , the upper half of the picture is an overall picture of the anti-paravalvular leakage material, and the lower half of the picture is a local enlarged picture of the part without the raised part. It can be seen from Figure 95 that the surface is uniform, there are no weak points in the mechanical properties, and the mechanical properties are better.

[1081] The elongation at break of the anti-paravalvular leakage materials prepared in Example 7 and Comparative Example 1 was tested. The test results are shown in Table 1.

[1082] Table 1

[1083] It can be seen from Table 1 that the elongation at break of the anti-paravalvular leakage material prepared in Comparative Example 1 is relatively small, and the subjective appearance of the material is that the material is relatively hard. When the stent is deformed, the anti-paravalvular leakage material cannot adapt to the deformation well, thus hindering the deformation of the stent.

[1084] As can be seen from Table 1, the anti-paravalvular leakage material prepared in Example 7 has a large elongation at break. When the stent is deformed, the flexible substrate and the protrusion can adapt well to the deformation of the stent, shrinking as the stent shrinks and expanding as the stent expands. Even when the stent is deformed to the maximum extent, the flexible substrate and the protrusion can still maintain good mechanical properties, especially elasticity, and can adapt to any possible shape of the stent.

[1085] Referring to Figures 42a to 42c, the PET material layer 100 and the PU material layer 200 have an interlayer 300 made of the same material as the protrusion. When forces F1 and F2 of equal magnitude and opposite directions are applied to the PET material layer 100 and the PU material layer 200, the PET material layer 100 and the interlayer 300 are separated, while the PU material layer 200 and the interlayer 300 remain fixed.

[1086] The technical features of the above-described embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as no contradiction exists between these combinations of technical features, they should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be deemed that the drawing also discloses examples of combinations of the various embodiments involved.

[1087] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person skilled in the art may make various modifications and improvements without departing from the spirit of the present application, and such modifications and improvements are all within the scope of protection of the present application.

Claims

1. An artificial implant, characterized in that: include: The stent is a radially deformable cylindrical structure, and the stent has a through blood flow channel; A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel; The anti-circumferential leakage structure is arranged along the circumference of the bracket, and the anti-circumferential leakage structure is: A blocking component at least partially protrudes radially outward from the stent and the blocking component includes a deformable structure; and / or An outer skirt wrapped around the outer periphery of the bracket.

2. The artificial implant according to claim 1, characterized in that The artificial implant also includes an inner skirt located radially inside the stent, and the blocking component is an integral structure with at least one of the inner skirt and the outer skirt, or is wrapped in a radial gap between the two.

3. The artificial implant according to claim 2, characterized in that The blocking component is fixed to the inner skirt through the hollowed-out portion of the support grid and wraps at least a portion of the frame bars constituting the support grid.

4. The artificial implant according to claim 1, characterized in that The anti-leakage structure is an outer skirt located on the radial outer side of the stent, and the artificial implant also includes an inner skirt located on the radial inner side of the stent. The inner skirt and the outer skirt are an integral structure and are made of polyurethane.

5. The artificial implant according to claim 1, characterized in that The anti-circumferential leakage structure includes the blocking component and the outer skirt; The artificial implant also includes an inner skirt located radially inside the stent, the inner skirt and the outer skirt are connected at the inflow side of the stent to form a bag structure, at least a portion of the stent and at least a portion of the occluding component are located in the bag structure.

6. An artificial implant, characterized in that: include: The stent is a radially deformable cylindrical structure, and the stent has a through blood flow channel; A plurality of leaflets, each leaflet having a fixed edge and a free edge opposite to each other, wherein the fixed edge is fixed to the support, and the free edge is used to control the blood flow channel; A skirt, including an inner skirt located radially inwardly of the stent and / or an outer skirt located radially outwardly of the stent; The sealing assembly is a plurality of sealing blocks, which adopt a deformable structure and are arranged along the circumference of the bracket. At least a portion of the sealing assembly protrudes radially outward from the bracket. The sealing assembly is an integral structure with at least one of the inner skirt and the outer skirt, or is wrapped in the radial gap between the two.

7. The artificial implant according to claim 6, characterized in that The blocking assembly includes a plurality of blocking blocks, which are spaced apart in a plurality of groups in the circumferential direction of the bracket. There is at least one blocking block in the same group, and there are spacing areas between adjacent groups. All the blocking blocks avoid the spacing areas in the circumferential direction of the bracket.

8. The artificial implant according to claim 6, characterized in that The blocking assembly includes a plurality of blocking blocks embedded in a support grid. The blocking blocks in two circumferentially adjacent support grids are staggered along the axial direction of the support. Along the axial direction of the support, the two sides of the blocking block itself are opposite wide sides and narrow sides, and the wide sides of the blocking blocks in two adjacent support grids are opposite to each other.

9. The artificial implant according to claim 6, characterized in that The sealing component forms at least two circles of wave peaks on the outer periphery of the stent, the two circles of wave peaks are arranged along the axial direction of the stent and form a trough area that can accommodate the native valve ring. The same circle of wave peaks is a plurality of sealing blocks arranged at intervals along the circumferential direction or a sealing ring distributed continuously along the circumferential direction.

10. The artificial implant according to claim 6, characterized in that The support has an inflow side and an outflow side opposite to each other, and the outer skirt is arranged on the inflow side; the support has a support grid, and the axial span of the outer skirt is 0.5 to 2 grids.

11. The artificial implant according to claim 6, characterized in that The outer skirt has an inflow edge and an outflow edge. Along the axial direction of the stent, the outflow edge of the outer skirt is adjacent to the midpoint of the fixed edge of the leaflet and does not exceed the outflow side of the midpoint.

12. The artificial implant according to claim 6, characterized in that The support as a whole has a waist portion, and the outflow edge of the outer skirt is located at the waist portion.

13. The artificial implant according to claim 6, characterized in that The support as a whole has a waist portion, and the distance between the outflow edge of the outer skirt and the waist portion is 0.5 to 1 grid.

14. The artificial implant according to claim 6, characterized in that A bag structure is formed between the outer skirt and the inner skirt, and the blocking component is located in the bag structure.

15. The artificial implant according to claim 6, characterized in that The bag structure extends continuously along the circumference of the stent or is arranged at intervals along the circumference of the stent.

16. The artificial implant according to claim 14, characterized in that Along the radial direction of the stent, the pouch structure is 0.5 to 20 mm higher than the outer peripheral wall of the stent.

17. The artificial implant according to claim 14, characterized in that The pouch structure is a fully closed structure; or the pouch structure is a semi-open structure, and the open portion is an opening toward the inflow side and / or the outflow side.

18. The artificial implant according to claim 17, characterized in that The openings are multiple and arranged at intervals along the circumference of the bracket.

19. The artificial implant according to claim 6, characterized in that The materials of the inner skirt and the outer skirt are: All are made of polyurethane, or One is made of polyurethane and the other is made of biomaterial, or All are biological materials, or The inner skirt is made of polyurethane material, and the outer skirt is made of PET fabric.

20. The artificial implant according to claim 6, characterized in that The inner skirt and the outer skirt both have an inflow edge and an outflow edge, the outflow edge of the inner skirt is connected to the fixed edges of the multiple leaflets, the inner skirt is made of a first sheet material, and the outer skirt is made of a second sheet material, and the inner skirt and the outer skirt are constructed as follows: A first sheet is fixed to the inner side of the bracket, a second sheet is fixed to the outer side of the bracket, and the inflow end of the bracket is exposed; or A first sheet is fixed on the inner side of the bracket, the first sheet is turned outward on the inflow side of the bracket and wraps the inflow end of the bracket, and a second sheet is fixed on the outer side of the bracket and connected to the turned-out part of the first sheet; or A second sheet is fixed on the outside of the bracket, the second sheet is turned inward on the inflow side of the bracket and wraps the inflow end of the bracket, and a first sheet is fixed on the inside of the bracket and connected to the inverted part of the second sheet; or A first sheet is fixed on the inner side of the bracket, and a second sheet is fixed on the outer side of the bracket. The first sheet and the second sheet are an integral structure and wrap the inflow end of the bracket. The blocking component is an integral structure with one of the first sheet and the second sheet, or is bonded to at least one of them, or is clamped between the two. The radial position of the blocking component is inside or outside the second sheet.

21. The artificial implant according to claim 6, characterized in that The inflow edge of the inner skirt is roughly aligned with the inflow edge of the outer skirt, and the two are an integral structure or a separate connection to close the blood flow channel; the radial position of the blocking component is on the inner side or the outer side of the outer skirt.

22. The artificial implant according to claim 6, characterized in that The shapes of the inflow edges of the inner skirt and the outer skirt are independent of each other, and both have a smooth inflow edge or an inflow edge adapted to the shape of the support grid.

23. The artificial implant according to claim 6, characterized in that The outflow edge of the outer skirt extends smoothly along the circumference of the stent, or has axial undulations while extending along the circumference of the stent.

24. The artificial implant according to claim 23, characterized in that The degree of the axial undulation matches the shape of the frame bars of the stent grid, or matches the shape of the axial edge of the occluding component.

25. The artificial implant according to claim 20, characterized in that The first sheet material and / or the second sheet material is made of polyurethane and has a thickness of 0.02 to 0.2 mm; or The first sheet material is made of polyurethane, and the second sheet material is made of PET fabric.

26. The artificial implant according to claim 6, characterized in that The inner skirt and the outer skirt are connected and fixed to each other by at least one of bonding or sewing.

27. The artificial implant according to claim 26, characterized in that The inner skirt and the outer skirt are fixed continuously or at intervals along the circumference of the bracket.

28. The artificial implant according to claim 6, characterized in that The material of the blocking component is polyurethane or other polymer materials.

29. The artificial implant according to claim 20, characterized in that The blocking component is made of polyurethane, and is made of the same material as at least one of the first sheet and the second sheet, and has an integral structure.

30. The artificial implant according to claim 6, characterized in that The plugging component has an internal void.

31. The artificial implant according to claim 6, characterized in that The plugging component adopts a foam structure with a pore size of 5 to 500 microns and a porosity of 40 to 95%.

32. The artificial implant according to claim 6, characterized in that The blocking component arrangement includes: comprising a plurality of blocking blocks arranged along the circumference of the stent; or The blocking component is an annular component as a whole and is located at the outer periphery of the bracket. The blocking component is directly sleeved on the outer periphery of the bracket; or directly sleeved on the outer periphery of the outer skirt.

33. The artificial implant according to claim 32, characterized in that The plurality of blocking blocks are spaced apart and arranged in a plurality of groups in the circumferential direction of the stent. There is at least one blocking block in the same group. There are spacing areas between adjacent groups. All the blocking blocks avoid the spacing areas in the circumferential direction of the stent.

34. The artificial implant according to claim 32, characterized in that The plurality of blocking blocks are arranged in a plurality of groups at intervals in the circumferential direction of the stent, and there are 1 to 10 blocking blocks in the same group. The distribution area of ​​the blocking blocks in the same group is continuously distributed in the circumferential direction of the stent.

35. The artificial implant according to claim 32, characterized in that The distribution areas of all the multiple blocking blocks are continuously distributed in the circumferential direction of the stent.

36. The artificial implant according to claim 32, characterized in that The radial position of the blocking blocks is located inside the outer skirt, and each blocking block is embedded in a corresponding support grid or each blocking block is randomly filled between the two skirts.

37. The artificial implant according to claim 32, characterized in that The same grid may include only one continuously distributed blocking block, or may include multiple blocks arranged at intervals.

38. The artificial implant according to claim 32, characterized in that The support grid is multi-circle, and all the blocking blocks are distributed only in the same circle.

39. The artificial implant according to claim 32, characterized in that The blocking blocks in two adjacent stent grids are staggered along the axial direction of the stent.

40. The artificial implant according to claim 32, characterized in that Along the axial direction of the stent, the two sides of the blocking block itself are opposite wide sides and narrow sides, and the wide sides of the blocking blocks in two adjacent stent grids are opposite to each other.

41. The artificial implant according to claim 40, characterized in that The wide sides of all the blocking blocks are connected to each other and extend continuously along the circumference of the stent.

42. The artificial implant according to claim 32, characterized in that From a radial perspective of the stent, the blocking block is in a shape of a circle, an ellipse, a rectangle, a diamond, a triangle or a hexagon.

43. The artificial implant according to claim 32, characterized in that Each blocking block is embedded in a corresponding stent grid. Along the radial viewing angle of the stent, the blocking block is fully distributed in the stent grid, or is only distributed in a partial area of ​​the stent grid.

44. The artificial implant according to claim 32, characterized in that The blocking blocks are distributed in the central area of ​​the support grid or close to one end of the axial direction.

45. The artificial implant according to claim 32, characterized in that The same support grid is provided with two blocking blocks which are spaced apart along the axial direction, and each blocking block is adjacent to one end of the support grid in the axial direction.

46. ​​The artificial implant according to claim 32, characterized in that In the longitudinal section of the blocking block, the blocking block has an inner side facing the stent and an opposite outer side, and the outer side edge shape is a broken line, a smooth curve or a combination of the two.

47. The artificial implant according to claim 32, characterized in that The outer edge of the blocking block is a broken line, and the longitudinal section of the blocking block is generally a triangle, a rectangle or a trapezoid.

48. The artificial implant according to claim 32, characterized in that The outer edge of the blocking block is a smooth curve and has a radially highest point, and the axial position of the highest point in the stent grid is closer to the inflow side.

49. The artificial implant according to claim 32, characterized in that Along the radial direction of the stent, the thickness of the blocking block is uniform or non-uniformly distributed, wherein the maximum thickness is 0.5-5 mm.

50. The artificial implant according to claim 32, characterized in that The plugging component as a whole spans 0.5 to 3 grids in the axial direction.

51. The artificial implant according to claim 32, characterized in that The longitudinal cross-section of the annular member is in the shape of a circle, a truncated circle, a trapezoid, a rectangle, an ellipse, a B-shape, a triangle, etc.

52. The artificial implant according to claim 6, characterized in that The installation position of the blocking component is: The blocking component is fixed to the inner skirt and protrudes from the radial inner side of the stent to the radial outer side of the stent via the corresponding grid, and the outer skirt surrounds the outer side of the blocking component; or The blocking component is fixed to the inner side of the outer skirt and is located in the sandwich layer between the outer skirt and the inner skirt; or The blocking component is fixed to the outer side of the outer skirt.

53. The artificial implant according to claim 6, characterized in that The outer skirt surrounds the outside of the blocking component, and the outer skirt wraps all or part of the blocking component.

54. The artificial implant according to claim 6, characterized in that In the longitudinal section of the blocking component, the outer edge shape of the blocking component has two wave peaks and a wave valley between the two wave peaks, and the outflow side of the outer skirt is located at the position of the wave valley.

55. The artificial implant according to claim 6, characterized in that The artificial implant also includes: The reinforcement piece is embedded in the skirt and connected to the bracket through the suture thread passing through the reinforcement piece.

56. The artificial implant according to claim 55, characterized in that The reinforcement member avoids or passes through the blocking component.

57. The artificial implant according to claim 55, characterized in that The outer skirt and the inner skirt are connected to the bracket by sutures, at least one of the outer skirt and the inner skirt is provided with a reinforcement, and the sutures pass through the reinforcement.

58. The artificial implant according to claim 55, characterized in that The reinforcement member is a sewing reinforcement line or reinforcement fabric pre-buried in the skirt, or the reinforcement member is a reinforcement gasket directly attached to the outer skirt and / or the inner skirt.

59. The artificial implant according to claim 55, characterized in that The reinforcement member is made of polyurethane or PET.

60. The artificial implant according to claim 57, characterized in that The reinforcing gasket is located on the outer side of the outer skirt or the inner side of the inner skirt, or between the outer skirt and the inner skirt in a radial direction.

61. The artificial implant according to claim 57, characterized in that The reinforcing gasket and the skirt against which it abuts are an integral structure or are fixed separately.

62. The artificial implant according to claim 57, characterized in that At the joint portion between the inner skirt and the flap, the reinforcing gasket, the flap, and the inner skirt are stacked and fixed in any order.

63. The artificial implant according to claim 55, characterized in that The reinforcement is distributed on the entire inner skirt or is only located on the outflow side of the inner skirt and is connected with the fixed edge of the valve leaf.

64. The artificial implant according to claim 55, characterized in that The suture avoids or passes through the occluding component.

65. The artificial implant according to claim 58, characterized in that The suture reinforcement line extends along the circumference of the stent to form a line loop, and the line loop is one circle or multiple circles, wherein the multiple circles of the line loop are arranged at intervals or extend continuously in a spiral manner.

66. The artificial implant according to claim 6, characterized in that The artificial implant also includes: The developing marker is embedded in the skirt and / or the occluding component. The joint between adjacent leaflets at the stent site is a joint part. The circumferential position of the developing marker corresponds to each joint part. The developing marker is at least a group. The axial position of this group is adjacent to the inflow side of the stent, and the axial distance between the leaflets can at least accommodate the native valve ring.

67. The artificial implant according to claim 66, characterized in that The artificial implant also includes: A reinforcement member, embedded in the skirt and connected to the bracket via a suture thread passing through the reinforcement member; At least one of the outer skirt, the inner skirt, the blocking component, and the reinforcement is pre-embedded with a developing mark.

68. The artificial implant according to claim 66, characterized in that The formation of the development mark includes at least one of the following methods: The developing mark is preformed and used as an embedded part in the synthesis process; The development mark is mixed into at least one raw material in the synthesis process.

69. The artificial implant according to claim 66, characterized in that The developing mark is in the form of strips, powder, flakes or blocks.

70. The artificial implant according to claim 66, characterized in that The development mark is in a strip shape and extends along the axial direction or circumferential direction of the stent.

71. The artificial implant according to claim 66, characterized in that The blocking component is an annular member, and the developing marks are arranged along the circumference of the annular member.

72. The artificial implant according to claim 66, characterized in that The blocking component is a plurality of blocking blocks, wherein at least two of the blocking blocks are provided with developing marks.

73. The artificial implant according to claim 72, characterized in that The development mark is located in the central area of ​​the blocking block.

74. The artificial implant according to claim 66, characterized in that In the longitudinal section of the blocking component, the outer edge shape of the blocking component has two wave crests and a wave valley between the two wave crests, and the developing mark includes a first mark and a second mark, and the two marks are respectively located at the corresponding wave crests.

75. The artificial implant according to claim 66, characterized in that In the longitudinal section of the blocking component, the outer edge shape of the blocking component has two wave crests and a wave valley between the two wave crests, and the developing mark is located at the wave valley.

76. The artificial implant according to claim 66, characterized in that The joint portion of two circumferentially adjacent leaflets on the stent is a joint portion, and the development marks are multiple groups, and each group matches a corresponding joint portion position along the circumference of the stent.

77. The artificial implant according to claim 66, characterized in that Along the axial direction of the stent, the development mark is adjacent to the inflow side of the stent.

78. An anti-leakage device for artificial implants, characterized in that: The artificial implant has a grid structure and a cylindrical support, and the anti-circumferential leakage device includes: A plurality of blocking blocks are arranged along the circumference of the bracket, each blocking block adopts a deformable structure and is embedded in a grid structure corresponding to a position; A pulling wire, through which the blocking blocks are connected to each other.

79. The peripheral leakage prevention device according to claim 78, characterized in that: In correspondence with the grid structure, the blocking blocks are arranged in multiple circles, each circle is arranged along the axial direction of the stent, and adjacent circles are staggered with each other.

80. The device for preventing peripheral leakage according to claim 78, characterized in that: The blocking blocks in the same circle are connected only by the pulling wire.

81. The device for preventing peripheral leakage according to claim 78, characterized in that: Connecting strips formed integrally with the blocking blocks are arranged between adjacent blocking blocks in the same circle.

82. The device for preventing peripheral leakage according to claim 78, characterized in that: The blocking block completely fills the grid structure in which it is located.

83. The device for preventing peripheral leakage according to claim 78, characterized in that: The blocking block partially fills the grid structure where it is located.

84. The device for preventing peripheral leakage according to claim 78, characterized in that: The blocking blocks are arranged in two circles, wherein the first circle completely fills the grid structure, and the second circle partially fills the grid structure.

85. The device for preventing peripheral leakage according to claim 84, characterized in that: In the first circle, there is a spacing portion between two adjacent blocking blocks, and each blocking block in the second circle is located at a corresponding spacing portion.

86. The device for preventing peripheral leakage according to claim 78, characterized in that: Along the axial direction of the stent, the grid structure has a middle area and edge areas on both sides of the middle area; along the radial direction of the stent, the thickness of the blocking block decreases from the middle area of ​​the grid area to the edge area, and along the circumferential direction of the stent, the width of the blocking block decreases from the middle area of ​​the grid area to the edge area.

87. The device for preventing peripheral leakage according to claim 78, characterized in that: The blocking block is a porous structure.

88. The device for preventing peripheral leakage according to claim 87, characterized in that: The blocking block is made of foamed polyurethane.

89. The peripheral leakage prevention device according to claim 87, characterized in that: The porosity of the blocking block is 50-85%.

90. The device for preventing peripheral leakage according to claim 78, characterized in that: Along the radial direction of the stent, the anti-leakage device has an inner side and an outer side opposite to each other, and the pull wire is located close to the inner side.

91. The device for preventing peripheral leakage according to claim 78, characterized in that: The pulling wire is located inside the bracket, and the blocking block protrudes outside the outer peripheral surface of the bracket.

92. The device for preventing peripheral leakage according to claim 78, characterized in that: The anti-circumferential leakage device has a curled state wound around the bracket and a relatively straightened state. In the straightened state, a plurality of pulling wires are arranged according to their own extending directions.

93. The peripheral leakage prevention device according to claim 92, characterized in that: At least one of the puller wires passes through all the occluding blocks.

94. The device for preventing peripheral leakage according to claim 92, characterized in that: The blocking blocks are arranged in multiple circles, and the circles are arranged along the axial direction of the stent, and at least one pulling wire passes through all the blocking blocks in one circle.

95. The peripheral leakage prevention device according to claim 92, characterized in that: In the straightened state, two of the pulling lines are parallel to each other.

96. The peripheral leakage prevention device according to claim 92, characterized in that: In the straightened state, two of the pulling lines intersect.

97. The device for preventing peripheral leakage according to claim 92, characterized in that: In the curled state, at least one pulling line extends along the length direction of the peripheral leakage prevention device.

98. The device for preventing peripheral leakage according to claim 92, characterized in that: In the straightened state, at least one pulling line extends along the length direction of the peripheral leakage prevention device.

99. The peripheral leakage prevention device according to claim 92, characterized in that: In the straightened state, at least two of the pulling lines extend along the length direction of the peripheral leakage prevention device.

100. The device for preventing peripheral leakage according to claim 78, characterized in that: The pulling wires include at least two groups, each group is a plurality of wires parallel to each other, one group extends along the length direction of the peripheral leakage prevention device, and the other group extends along the width direction of the peripheral leakage prevention device.

101. The device for preventing peripheral leakage according to claim 100, characterized in that: The pulling wires with different extension directions belong to the same wire and are wound in a circuitous manner.

102. The device for preventing peripheral leakage according to claim 78, characterized in that: In correspondence with the grid structure, the blocking blocks are arranged in one or more circles, and there is at least one pulling line passing through the same circle of blocking blocks and extending along the length direction of the peripheral leakage prevention device in a straightened state.

103. The device for preventing peripheral leakage according to claim 78, characterized in that: Along the width direction of the peripheral leakage prevention device in the straightened state, among the pulling lines passing through the same circle of blocking blocks, at least one is adjacent to the middle area of ​​the blocking blocks.

104. The device for preventing peripheral leakage according to claim 78, characterized in that: A limiting component is fixed on the pulling wire, and the limiting component is embedded in the blocking block.

105. The device for preventing peripheral leakage according to claim 78, characterized in that: The limiting component is a wire knot.

106. The device for preventing peripheral leakage according to claim 105, characterized in that: The limiting component also includes a circuitous structure connected to the knot.

107. The device for preventing peripheral leakage according to claim 78, characterized in that: The pulling wires are all connected via the limiting components.

108. The device for preventing peripheral leakage according to claim 78, characterized in that: The pulling wire is made of PTFE.

109. The device for preventing peripheral leakage according to claim 78, characterized in that: The anti-circumferential leakage device also includes an inner lining film. In a curled state, the inner lining film is located inside, and each blocking block is fixed on the outside of the inner lining film.

110. The device for preventing peripheral leakage according to claim 78, characterized in that: There is a spacing portion between two adjacent blocking blocks in the same circle, and a portion of the pulling wire is located at the spacing portion on its own extension path, and the portion is adhered and fixed to the inner lining film.

111. The device for preventing peripheral leakage according to claim 109, characterized in that: The lining film and the blocking block are made of the same material.

112. The device for preventing peripheral leakage according to claim 78, characterized in that: The thickness of the lining film is 0.01-0.5 mm. 113.An anti-leakage device for artificial implants, characterized in that: The artificial implant has a grid structure and a cylindrical support, and the anti-circumferential leakage device includes: A plurality of blocking blocks are arranged along the circumference of the bracket, each blocking block adopts a deformable structure and is embedded in a grid structure corresponding to a position; The lining film, the plurality of blocking blocks are fixed on one side of the lining film, and the lining film and the plurality of blocking blocks are made of the same material.

114. An artificial implant, characterized in that It comprises a support and a peripheral leakage prevention device wrapped around the support, wherein the support is cylindrical and has a grid structure, and the peripheral leakage prevention device comprises: A plurality of blocking blocks are arranged along the circumference of the artificial implant, each blocking block adopts a deformable structure and is embedded in a grid structure corresponding to a position; The blocking blocks are connected to each other through the pulling wire to form a peripheral leakage prevention device. Or the anti-circumferential leakage device includes: A plurality of blocking blocks are arranged along the circumference of the bracket, each blocking block adopts a deformable structure and is embedded in a grid structure corresponding to a position; The lining film, the plurality of blocking blocks are fixed on one side of the lining film.

115. The artificial implant according to claim 114, characterized in that The lining film and the plurality of blocking blocks are made of the same material.

116. The artificial implant according to claim 114, characterized in that The artificial implant is an artificial heart valve.

117. A method for processing an artificial implant, characterized in that: include: A support and a peripheral leakage prevention device are provided respectively, wherein the support is cylindrical and has a grid structure, and the peripheral leakage prevention device comprises: A plurality of blocking blocks are arranged along the circumference of the artificial implant, and each blocking block adopts a deformable structure; A pulling line, through which the blocking blocks are connected to each other to form a peripheral leakage prevention device; The processing method comprises: The anti-leakage device is curled up and connected end to end to form a curled state; The anti-leakage device in a curled state is fixed to the bracket, and each blocking block is embedded in the grid structure corresponding to the position during fixing.

118. A method for processing an artificial implant, characterized in that: include: A support and a peripheral leakage prevention device are provided respectively, wherein the support is cylindrical and has a grid structure, and the peripheral leakage prevention device comprises: A plurality of blocking blocks are arranged along the circumference of the artificial implant, and each blocking block adopts a deformable structure; A pulling line, through which the blocking blocks are connected to each other to form a peripheral leakage prevention device; The processing method comprises: Placing a portion of the anti-leakage device in the length direction inside or outside the bracket and fixing it to the bracket; The rest of the peripheral leakage prevention device is gradually fixed to the bracket until the peripheral leakage prevention device is connected end to end in a curled state, and each blocking block is embedded in the grid structure corresponding to the position when fixed.

119. A mold for forming a peripheral leakage prevention device, characterized in that: The invention comprises a main body, and a working surface on one side of the main body is provided with: Multiple mold cavities for forming plugging blocks; The wire groove intersects with the mold cavity and is used for passing the pulling wire. The formed blocking blocks are connected by the pulling wire to form the anti-circumferential leakage device.

120. The mold for forming the anti-leakage device according to claim 119, characterized in that: The wire groove is open on the working surface.

121. The mold for forming the anti-leakage device according to claim 119, characterized in that: The wire groove extends to the edge of the body.

122. The mold for forming the anti-circumferential leakage device as claimed in claim 119, characterized in that: The wire groove extends along a straight line.

123. A mold for forming a peripheral leakage prevention device, characterized in that: include: A main body, a working surface on one side of the main body, and a plurality of mold cavities are provided on the working surface for forming the blocking block; A molding frame is superimposed on the working surface and surrounds the outer periphery of the mold cavity opening.

124. The mold for forming the anti-circumferential leakage device according to claim 123, characterized in that: The molding frame and the body are of separate structures or integrated structures.

125. The mold for forming the anti-leakage device according to claim 124, characterized in that: The working surface has a sedimentation area, and the multiple mold cavities are located in the sedimentation area.

126. The mold for forming the anti-leakage device according to claim 124, characterized in that: The depth of the sedimentation zone and the thickness of the forming frame both correspond to the thickness of the lining film.

127. A method for forming an anti-leakage device using a mold, characterized in that: include: Adding blocking block raw materials into multiple mold cavities of the mold; Laying a pulling wire, wherein an extension path of the pulling wire intersects with the mold cavity; solidifying the blocking block material under predetermined conditions; The sealing blocks which have been formed and connected by the pulling wires are demoulded to obtain the anti-circumferential leakage device.

128. The method of claim 127, wherein: Adding the blocking block material and laying the pulling wire can be performed in any order or alternately.

129. The method of claim 127, wherein: The material of the blocking block is in a fluid or paste state, and is leveled or scraped to be at the same height as the working surface.

130. The method of claim 127, wherein: Before solidifying the blocking block material, a coating is formed on the top side of the blocking block material using a lining film material, and then the lining film material and the blocking block material are solidified simultaneously.

131. The method of claim 127, wherein: At least one of the blocking block material and the lining film material is in a paste state.

132. The method of claim 127, wherein: The blocking block raw material contains solid particles, and the method further comprises removing the solid particles after demoulding.

133. The method of claim 127, wherein: The curing temperature is 10-60°C, and the curing time is 1-24 hours. 134.Anti-valve leakage skirt, characterized in that: At least a portion of the anti-paravalvular leakage skirt has a flexible substrate, and at least a portion of the anti-paravalvular leakage skirt has a reinforcing component in the form of fabric, wherein the flexible substrate and the reinforcing component have an overlapping area.

135. The anti-paravalvular leakage skirt according to claim 134, characterized in that: The anti-valvular leakage skirt comprises: Flexible substrate, using polyurethane film; The reinforcing component is in the form of fabric, and at least a portion of the reinforcing component and at least a portion of the flexible substrate are overlapped and fixed to each other.

136. The anti-paravalvular leakage skirt according to claim 135, characterized in that: At least a portion of the reinforcement component extends out of the flexible substrate.

137. The anti-paravalvular leakage skirt according to claim 135 or 136, characterized in that: The anti-paravalvular leakage skirt also includes a sealing component fixed to the flexible substrate, and the sealing component adopts a deformable structure.

138. The anti-paravalvular leakage skirt of claim 134, wherein: The elongation at break of the flexible substrate is not less than 200%, and the tensile strength of the flexible substrate is 30-100 MPa.

139. The anti-paravalvular leakage skirt according to claim 138, characterized in that The plugging component is polyurethane with an open pore structure.

140. The anti-paravalvular leakage skirt of claim 139, wherein: The pores in the plugging component are interconnected and have uniform pore diameters.

141. The anti-paravalvular leakage skirt of claim 139, wherein: The porosity of the plugging component is 50-95%.

142. The anti-paravalvular leakage skirt of claim 135, wherein: The fabric is a flexible fabric, and the thickness of the fabric ranges from 0.04 mm to 0.2 mm.

143. The anti-paravalvular leakage skirt according to claim 135, characterized in that: The raw material of the fabric is one of polyester, nylon and polyetheretherketone.

144. The anti-paravalvular leakage skirt according to claim 135, characterized in that: The fabric is a woven fabric with a weft knitted structure.

145. The anti-paravalvular leakage skirt of claim 136, wherein: The anti-paravalvular leakage skirt has an inflow end and an outflow end opposite to each other according to the expected blood flow direction under a physiological environment, and the portion of the reinforcing component extending out of the flexible substrate is located at the outflow end.

146. The anti-paravalvular leakage skirt according to claim 145, characterized in that The blocking component is located at the inflow end of the anti-paravalvular leakage skirt.

147. The anti-paravalvular leakage skirt according to claim 146, characterized in that In the axial direction of the anti-paravalvular leakage skirt, there is a distance between the blocking component and the reinforcing component.

148. The anti-paravalvular leakage skirt according to claim 147, characterized in that: The distance between the blocking component and the reinforcing component is 3 to 20 mm.

149. The anti-paravalvular leakage skirt of claim 137, wherein: The blocking component and the reinforcing component are located on the same side of the flexible substrate, or the blocking component and the reinforcing component are located on different sides of the flexible substrate.

150. The anti-paravalvular leakage skirt of claim 137, wherein: The blocking component is raised relative to the flexible substrate.

151. The anti-paravalvular leakage skirt according to any one of claims 134 to 136, characterized in that: The flexible substrate has a first edge and a second edge opposite to each other, the first edge corresponds to the inflow end of the anti-paravalvular leakage skirt, the second edge is used to be fixed on the stent after being sutured with the valve leaflet, and the second edge is closer to the outflow end of the stent than the first edge; The reinforcing component has a third edge and a fourth edge opposite to each other, and the fourth edge of the reinforcing component has the same shape as the second edge of the flexible substrate.

152. The anti-paravalvular leakage skirt according to claim 151, characterized in that: The third edge and the fourth edge of the reinforcing component have the same shape, and the reinforcing component is substantially wavy in shape and has the same width at all locations.

153. The anti-paravalvular leakage skirt of claim 151, wherein: The third edge of the reinforcing component is a smooth arc.

154. The anti-paravalvular leakage skirt of claim 151, wherein: The fourth edge of the reinforcing component is flush with the second edge of the flexible substrate.

155. The anti-paravalvular leakage skirt according to any one of claims 134 to 136, characterized in that: The flexible substrate has a first edge and a second edge opposite to each other, the second edge being closer to the outflow end of the stent than the first edge; The reinforcing component has a third edge and a fourth edge opposite to each other, and the fourth edge of the reinforcing component extends beyond the second edge of the flexible substrate to form an extension for sewing.

156. The anti-paravalvular leakage skirt of claim 137, wherein: The blocking component is at least one protrusion fixed on the flexible substrate.

157. The anti-paravalvular leakage skirt of claim 135, wherein: The reinforcing component and the flexible substrate are connected by at least one of solvent bonding, solution bonding, hot melt bonding, and sewing splicing.

158. The anti-paravalvular leakage skirt of claim 157, wherein: The solvent used for the solvent bonding is at least one of dimethyl sulfoxide, N,N-dimethylformamide and N,N-dimethylacetamide.

159. The anti-paravalvular leakage skirt of claim 157, wherein: The solution used in the solution bonding is a polyurethane solution, and the concentration of the polyurethane solution is 5-20wt%.

160. The anti-paravalvular leakage skirt of claim 157, wherein: When using solution or solvent for bonding, after the joint is completely soaked by the solvent or solution, it is dried at a temperature of 50 to 70 degrees.

161. The anti-paravalvular leakage skirt of claim 157, wherein: The temperature of the hot melt bonding is 50-70°C, and the heating time is 0.5-2h.

162. The anti-paravalvular leakage skirt of claim 137, wherein: The blocking component is connected to the flexible substrate via a bonding area, and the bonding area is formed by contact, penetration and solidification of the flexible substrate and the adjacent parts of the protrusion in the form of a solution.

163. The anti-paravalvular leakage skirt of claim 135, wherein: The thickness T1 of the flexible substrate is 0.03 mm to 0.05 mm, the thickness T2 of the reinforcing component is 0.04 to 0.2 mm, the thickness T3 of the overlapping and fixed portion of the flexible substrate and the reinforcing portion is 0.05 to 0.24 mm, and T1, T2, and T3 satisfy the constraint: 0.05 mm ≥ T1 + T2 - T3 ≥ 0.01 mm.

164. A method for preparing a paravalvular leakage prevention skirt, characterized in that: include: Respectively connecting the reinforcing component and the blocking component on the flexible substrate; The reinforcement components as well as the flexible substrate are cut to the desired shape.

165. The method for preparing the anti-paravalvular leakage skirt according to claim 164, characterized in that: The reinforcing component and the plugging component are connected to the flexible substrate in any of the following order: a) sequentially connecting a reinforcing component and a blocking component on the flexible substrate; b) Connecting the plugging component and the reinforcing component in sequence on the flexible substrate.

166. The method for preparing the anti-paravalvular leakage skirt according to claim 164, characterized in that: Cut the reinforcement and the flexible substrate to the desired shape in any of the following order: 1) Before connecting the reinforcing component to the flexible substrate, the flexible substrate and the reinforcing component are cut respectively; 2) After the reinforcing component is connected to the flexible substrate, the flexible substrate and the reinforcing component are cut at the same time.

167. The method for preparing the anti-paravalvular leakage skirt according to claim 164, characterized in that: The preparation of the plugging component includes: The polyurethane solution is mixed with solid particles to obtain a premix; The premix is ​​solidified and washed to obtain a plugging component containing a pore structure.

168. The method for preparing the anti-paravalvular leakage skirt according to claim 167, characterized in that: The particle size of the solid particles is 80-120 meshes.

169. An artificial implant, characterized in that include: The stent is a deformable tubular structure with a hollow area on the side wall, and the interior of the stent is a blood flow channel; A valve leaflet connected to the stent to control the blood flow channel; The anti-paravalvular leakage skirt as described in any one of claims 134 to 163, wherein the anti-paravalvular leakage skirt is located entirely inside the stent, the outflow end of the anti-paravalvular leakage skirt is docked with the leaflet, and the blocking component protrudes from the stent through the hollow area of ​​the stent.

170. The artificial implant according to claim 169, characterized in that The blocking component is located at the inflow end of the stent, and the axial height of the blocking component corresponds to 1 to 2 rows of cells at the inflow end of the stent.

171. The method for preparing an artificial implant as claimed in claim 169 or 170, characterized in that: include: A prefabricated product is formed by connecting the valve leaflets and the anti-paravalvular leakage skirt to each other and enclosing them into a cylindrical shape; The preform is assembled to the support.

172. Adaptive anti-paravalvular leakage material, characterized in that: The anti-paravalvular leakage material includes: a sheet-shaped and stretchable flexible substrate, and one or more protrusions attached to the flexible substrate, each protrusion has a pore structure, the flexible substrate and the protrusions are both made of polyurethane, and the connection between the flexible substrate and the protrusions is achieved by curing a polyurethane solution.

173. The adaptive anti-paravalvular leakage material according to claim 172, characterized in that: The elongation at break of the flexible substrate is not less than 200%.

174. The adaptive anti-paravalvular leakage material according to claim 173, characterized in that: The elongation at break of the flexible substrate is not less than 300%.

175. The adaptive anti-paravalvular leakage material according to claim 173, characterized in that: The elongation at break of the flexible substrate is 200% to 500%.

176. The adaptive anti-paravalvular leakage material according to claim 173, characterized in that: The aperture size of the protrusion is 5 to 500 microns.

177. The adaptive anti-paravalvular leakage material according to claim 176, characterized in that: The aperture size of the protrusion is 5 to 450 microns.

178. The adaptive anti-paravalvular leakage material according to claim 177, characterized in that: The aperture size of the protrusion is 5 to 400 microns.

179. The adaptive anti-paravalvular leakage material according to claim 178, characterized in that: The aperture size of the protrusion is 5 to 350 microns.

180. The adaptive anti-paravalvular leakage material according to claim 179, characterized in that: The aperture size of the protrusion is 5 to 300 microns.

181. The adaptive anti-paravalvular leakage material according to claim 180, characterized in that: The aperture size of the protrusion is 5 to 250 microns.

182. The adaptive anti-paravalvular leakage material according to claim 172, characterized in that: The porosity of the protrusion is 50-95%.

183. The adaptive anti-paravalvular leakage material according to claim 182, characterized in that: The porosity of the protrusion is 60-95%.

184. The adaptive anti-paravalvular leakage material according to claim 183, characterized in that: The porosity of the protrusion is 70-90%.

185. The adaptive anti-paravalvular leakage material according to claim 172, characterized in that: The protrusions have an open pore structure and / or a closed pore structure.

186. The adaptive anti-paravalvular leakage material according to claim 172, characterized in that: The average thickness of the flexible substrate is 0.02-0.20 mm.

187. The adaptive anti-paravalvular leakage material according to claim 186, characterized in that: The average thickness of the flexible substrate is 0.02-0.15 mm.

188. The adaptive anti-paravalvular leakage material according to claim 187, characterized in that: The average thickness of the flexible substrate is 0.02-0.12 mm.

189. The adaptive anti-paravalvular leakage material according to claim 172, characterized in that: The tensile strength of the flexible substrate is 30 to 100 MPa.

190. The adaptive anti-paravalvular leakage material according to claim 189, characterized in that: The tensile strength of the flexible substrate is 40 to 100 MPa.

191. The adaptive anti-paravalvular leakage material according to claim 190, characterized in that: The tensile strength of the flexible substrate is 50-100 MPa.

192. The adaptive anti-paravalvular leakage material according to claim 191, characterized in that: The tensile strength of the flexible substrate is 50-90 MPa.

193. The adaptive anti-paravalvular leakage material according to claim 192, characterized in that: The tensile strength of the flexible substrate is 50-80 MPa.

194. Adaptive anti-paravalvular leakage material, characterized in that: The anti-paravalvular leakage material includes: a sheet-shaped and stretchable flexible substrate, and one or more protrusions attached to the flexible substrate, each protrusion has a pore structure, the flexible substrate and the protrusions are both made of polyurethane, and the flexible substrate and the protrusions are connected through a bonding area, and the bonding area is formed by the contact, penetration, and solidification of the adjacent parts of the flexible substrate and the protrusions in the form of a solution.

195. The adaptive anti-paravalvular leakage material according to claim 194, characterized in that: The protrusion and the flexible substrate both have pore structures.

196. The adaptive anti-paravalvular leakage material according to claim 195, characterized in that: The porosity of the protrusion is not lower than that of the flexible substrate.

197. The adaptive anti-paravalvular leakage material according to claim 194, characterized in that: The flexible substrate is a dense structure without pores.

198. Adaptive anti-paravalvular leakage material, characterized in that: The anti-paravalvular leakage material is made of polyurethane, and includes: a sheet-shaped and stretchable flexible substrate, and one or more protrusions connected to the flexible substrate. The flexible substrate and the protrusions are both formed by a casting process, and the casting liquid of the protrusions is a polyurethane solution containing solid particles. The casting liquid of the flexible substrate is a polyurethane solution or a polyurethane mixture containing solid particles.

199. A method for preparing an adaptive anti-paravalvular leakage material, characterized in that: The steps include the following in any order: Filling a polyurethane mixture containing solid particles in a mold, and washing and removing the solid particles after curing to obtain a protrusion; The flexible substrate is obtained by curing a polyurethane solution, or by curing a polyurethane mixed solution containing solid particles and washing the mixed solution to obtain the flexible substrate. The connection between the flexible substrate and the protrusion is achieved by curing the polyurethane solution.

200. The preparation method according to claim 199, characterized in that The polyurethane molecular chain includes hard segments and soft segments, wherein the soft segment content is 40-70% and the rest is hard segments, the soft segment is at least one of polyether diol, polycarbonate diol, polyester diol and polysiloxane diol, and the hard segment is isocyanate, and the R value of the isocyanate is 1.0-1.

1.

201. The preparation method according to claim 199, characterized in that In the polyurethane molecular chain, the soft segment content is 50%-65%.

202. The preparation method according to claim 199, characterized in that The isocyanate is at least one of TDI, HDI, MDI, NDI, PPDI, IPDI, and XDI.

203. The preparation method according to claim 199, characterized in that The polyurethane molecular chain also includes a chain extender, which is at least one of ethylene glycol, butanediol, hexanediol, octanediol, and ethylenediamine.

204. The preparation method according to claim 199, characterized in that The solvent of the polyurethane solution is at least one of dimethyl sulfoxide, tetrahydrofuran, dimethylformamide, dimethylacetamide, dichloromethane, chloroform and hexafluoroisopropanol.

205. The preparation method according to claim 199, characterized in that The solvent of the polyurethane solution is two of dimethyl sulfoxide, tetrahydrofuran, dimethylformamide, dimethylacetamide, dichloromethane, chloroform and hexafluoroisopropanol, and the volume ratio of the two solvents is 1 to 99:

1.

206. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 5 to 95:

1.

207. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 10-95:

1.

208. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 15-95:

1.

209. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 20-95:

1.

210. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 25-95:

1.

211. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 10 to 90:

1.

212. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 10-80:

1.

213. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 15-75:

1.

214. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 20-75:

1.

215. The preparation method according to claim 205, characterized in that The volume ratio of the two solvents is 25-75:

1.

216. The method of claim 199, wherein: The concentration of polyurethane in the polyurethane solution is 0.25% to 25% (w / v).

217. The preparation method according to claim 199, characterized in that The concentration of polyurethane is 0.5% to 20% (w / v).

218. The method of claim 199, wherein: The concentration of polyurethane is 0.5% to 15% (w / v).

219. The preparation method according to claim 199, characterized in that The concentration of polyurethane is 0.5% to 10% (w / v).

220. The method of claim 199, wherein: The concentration of polyurethane is 5% to 25% (w / v).

221. The preparation method according to claim 199, characterized in that The concentration of polyurethane is 1% to 25% (w / v).

222. The preparation method according to claim 199, characterized in that The concentration of polyurethane is 2% to 25% (w / v).

223. The preparation method according to claim 199, characterized in that The concentration of polyurethane is 3% to 25% (w / v).

224. The method of claim 199, wherein: The concentration of polyurethane is 4% to 25% (w / v).

225. The method of claim 199, wherein: The concentration of polyurethane is 5% to 20% (w / v).

226. The method of claim 199, wherein: The concentration of polyurethane is 5% to 15% (w / v).

227. The preparation method according to claim 199, characterized in that The concentration of polyurethane is 8% to 20% (w / v).

228. The preparation method according to claim 199, characterized in that The concentration of polyurethane is 10% to 20% (w / v).

229. The preparation method according to claim 199, characterized in that The solid particles are at least one of sodium chloride, potassium chloride and sucrose.

230. The preparation method according to claim 199, characterized in that The number average particle size of the solid particles is 5 to 500 microns.

231. The preparation method according to claim 199, characterized in that The number average particle size of the solid particles is 5 to 450 microns.

232. The preparation method according to claim 199, characterized in that The number average particle size of the solid particles is 5 to 400 microns.

233. The preparation method according to claim 199, characterized in that The number average particle size of the solid particles is 5 to 350 microns.

234. The preparation method according to claim 199, characterized in that The number average particle size of the solid particles is 5 to 300 microns.

235. The preparation method according to claim 199, characterized in that The number average particle size of the solid particles is 5 to 250 microns.

236. The preparation method according to claim 199, characterized in that In the polyurethane mixed liquid containing solid particles, the mass fraction of the solid particles is 50% to 80%.

237. The preparation method according to claim 199, characterized in that The mass fraction of solid particles is 55% to 80%.

238. The preparation method according to claim 199, characterized in that The mass fraction of solid particles is 60% to 80%.

239. The preparation method according to claim 199, characterized in that The mass fraction of solid particles is 60% to 75%.

240. The preparation method according to claim 199, characterized in that The mold includes a plurality of mold cavities, each mold cavity corresponds to a protrusion, and the distribution of the mold cavities is consistent with the distribution of the protrusions.

241. The preparation method according to claim 199, characterized in that The curing temperature of the protrusion and the flexible substrate is 20 to 90°C.

242. The preparation method according to claim 199, characterized in that The curing temperature of the protrusion and the flexible substrate is 20-70°C.

243. The preparation method according to claim 199, characterized in that The curing temperature of the protrusion and the flexible substrate is 20-50°C.

244. The preparation method according to claim 199, characterized in that The protrusions and the flexible substrate also include post-treatment after curing, and the post-treatment includes: placing the protrusions and the flexible substrate in 20-40°C water for at least 1 hour.

245. The preparation method according to claim 244, characterized in that The post-treatment comprises: placing the protrusion and the flexible substrate into 20-40°C water for 2-4 hours.

246. The preparation method according to claim 199, characterized in that The preparation of the protrusion and the flexible substrate also includes pre-curing before the curing step, and the pre-curing conditions are: pre-curing temperature 20-70°C, pre-curing time 20-60 minutes.

247. The preparation method according to claim 246, characterized in that The pre-curing conditions are: pre-curing temperature 30-60°C, pre-curing time 20-40 minutes.

248. The preparation method according to claim 199, characterized in that Washing the raised portion and the flexible substrate includes placing the raised portion in a detergent for at least 4 hours.

249. The preparation method according to claim 199, characterized in that Washing the protrusions and the flexible substrate includes placing the protrusions in a detergent and leaving them to stand for 4 to 12 hours.

250. The method of claim 199, wherein: Washing the raised portions and the flexible substrate comprises subjecting the raised portions to a detergent treatment in an agitated state for at least 4 hours.

251. The method of claim 199, wherein: The washing of the protrusions and the flexible substrate comprises: placing the protrusions in a detergent in an agitated state for 4 to 12 hours.

252. The method of claim 199, wherein: The polyurethane solution in contact with the protrusion is at room temperature or has been preheated, and the preheating temperature of the polyurethane solution is 30-70°C.

253. The preparation method according to claim 199, characterized in that The preheating temperature of the polyurethane solution is 40-70°C.

254. The preparation method according to claim 199, characterized in that The preheating temperature of the polyurethane solution is 50-70°C.

255. The method of claim 199, wherein: The preparation of the protrusion and the flexible substrate also includes a preliminary curing before the pre-curing step, and the preliminary curing can be performed in one of the following ways: a) Blowing hot air on the surface of the polyurethane mixture containing solid particles; b) spraying hot steam on the surface of the polyurethane mixture containing solid particles; c) adding water, ethanol or isopropanol dropwise to the polyurethane mixture containing solid particles; In step a), the hot air temperature is 40-100°C, and the blowing time is 0.5-2 min. In step b), the steam temperature is 40-100°C, and the spraying time is 0.5-2 min. In step c), 1 to 2.5 mL is added dropwise.

256. An artificial heart valve, characterized in that include: The stent has a blood flow channel inside, and the stent has an inflow side and an outflow side opposite to each other, and the inflow side has a grid structure; One or more leaflets; The anti-paravalvular leakage material is connected to the inflow side, the flexible substrate of the anti-paravalvular leakage material is located inside the stent, and the protrusion is embedded in the grid structure; or the flexible substrate of the anti-paravalvular leakage material is located outside the stent, and the protrusion is located on the side of the flexible substrate away from the stent.

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