Artificial implant, interventional system, and method for driving blocking member on artificial implant to deform

Abstract

An artificial implant, an interventional system, and a method for driving a blocking member on an artificial implant to deform. The artificial implant comprises: a stent; and a blocking member, which is connected to the stent and is arranged in the circumferential direction of the stent, the blocking member being provided with a first guide structure. When the stent is in a deployed state, at least part of the blocking member protrudes out of the circumference of the stent; and when the stent is in a compressed state, the blocking member is folded at the first guide structure so as to fit to the deformation of the stent. Providing the blocking member can effectively reduce the occurrence rate of perivalvular leakage; the first guide structure can enable the blocking member to fit to the deformation of the stent, thereby effectively preventing the defects of access limitation and being prone to dislodgement and rupture, and providing a sufficient structural basis for optimization setting of artificial implants.

Description

Artificial implant, interventional system, and method for driving deformation of sealing component on artificial implant Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an artificial implant, an interventional system, and a method for driving a sealing component on an artificial implant to deform. Background Art

[0002] Heart valve replacement surgery is widely used clinically as an effective treatment for valvular heart disease. However, the industry has not yet found a suitable solution to the problem of paravalvular leakage (PVL). Paravalvular leakage is a non-structural valvular dysfunction that often occurs in the early and late stages after prosthetic valve replacement. Treatment options for PVL include surgical and interventional therapies. Regardless of the approach, both procedures are associated with increased complications, mortality, and a high incidence of recurrent PVL.

[0003] Therefore, those skilled in the art have considered reducing the incidence of paravalvular leakage through valve design. A common approach is to add a skirt to the inflow end of the valve to block the leakage. Skirts are primarily made of biological or polymeric materials. However, the introduction of a skirt increases the size of the delivery device access path, limits the design of the prosthetic valve, and can easily lead to skirt damage during delivery, among other issues. This has had a significant impact on the development of this technology. Technical issues

[0004] In order to solve the above technical problems, the anti-circular leakage component is further improved. Technical Solutions

[0005] The present application discloses an artificial implant, comprising:

[0006] The stent is a tubular structure that is radially deformable and has corresponding compressed and expanded states as it deforms;

[0007] The blocking component is connected to the stent and arranged along the circumference of the stent. When the stent is in an expanded state, at least a portion of the blocking component protrudes beyond the periphery of the stent. When the stent is in a compressed state, the blocking component is guided to fold to adapt to the deformation of the stent.

[0008] 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.

[0009] Optionally, the deformation of the stent acts on a predetermined position of the blocking component to guide the blocking component to fold, and when folding, at least a portion of the blocking component moves radially inward of the stent.

[0010] Optionally, the deformation of the stent directly acts on the blocking component, and / or indirectly acts on the blocking component.

[0011] Optionally, the blocking component has a first guiding structure, and when the stent is in a compressed state, the blocking component is folded at the first guiding structure.

[0012] Optionally, the artificial implant further comprises:

[0013] An actuator is connected to the stent. When the stent is transformed from the expanded state to the compressed state, the actuator acts radially inward along the stent to at least a portion of the blocking component to guide the blocking component to fold.

[0014] Optionally, the bracket has a grid structure, and during the transition between different states of the bracket, the axial length of at least one grid in the grid structure changes accordingly, and the actuator responds to the change in the axial length of the grid or multiple grids.

[0015] Optionally, the actuator is driven by the bracket to act radially inward along the bracket to the blocking component.

[0016] Optionally, the actuator drives the bracket to deform.

[0017] Optionally, the bracket has a grid structure.

[0018] Optionally, the stent has an axially opposite inflow side and outflow side in a blood flow environment, the interior of the stent is a blood flow channel, and the artificial implant further includes a leaflet connected to the stent and used to control the blood flow channel.

[0019] Optionally, the leaflets are 2, 3 or 4 leaflets that cooperate with each other. Optionally, the leaflets are made of biological materials or polymer materials.

[0020] Optionally, the blocking component is located on the inflow side of the leaflet. Optionally, the first guiding structure includes at least one fracture site, and when the stent is in a compressed state, the blocking component folds at the fracture site and collapses radially inward of the stent.

[0021] Optionally, the actuating member and the first guiding structure are arranged in corresponding positions or staggered positions.

[0022] Optionally, when the stent is in an expanded state, at least a portion of the actuator extends through the fracture site.

[0023] Optionally, the blocking component is a plurality of deformable blocking blocks, each of which is arranged at intervals, and the fracture portion is a slit opened in the blocking block. Optionally, the slit extends with a constant width or with varying widths.

[0024] Optionally, the width of the slit is 0-1 mm. Optionally, the blocking block is PU foam.

[0025] Optionally, the extending direction of the slit is consistent with the stent busbar. Optionally, along the radial direction of the stent, the depth of the slit is at least half of the thickness of the blocking block.

[0026] Optionally, along the radial direction of the stent, the depth of the slit passes through the blocking block, and the blocking block is connected on both sides of the slit by other components. Optionally, the other components are reinforcement wires passing through the blocking block.

[0027] Optionally, different parts of the blocking block have different thicknesses in the radial direction of the stent, and the slit at least intersects with the part with the largest thickness.

[0028] Optionally, the slit passes through the blocking block along the axial direction of the stent, or at least one side is a closed side.

[0029] Optionally, the blocking block is provided with a reinforcement line pulled on both sides of the slit.

[0030] Optionally, the threading path of the reinforcement wire avoids the stent or wraps around the stent.

[0031] Optionally, the reinforcement line is fixed by knotting or by an additional connecting piece.

[0032] Optionally, for the same slit, there is one reinforcement line that is passed back and forth on both sides of the slit.

[0033] Optionally, for the same slit, there are multiple reinforcement lines, and each reinforcement line is wound around itself or with each other to form a knot.

[0034] Optionally, there are multiple knots, which are arranged at intervals along the extension direction of the slit.

[0035] Optionally, the fracture portion is a groove formed in the blocking block.

[0036] Optionally, the opening side of the groove faces the radial outer side of the stent. Optionally, the depth of the groove is at least half of the thickness of the blocking block.

[0037] Optionally, the depth of the groove passes through the blocking block, and the blocking block itself is an annular structure.

[0038] Optionally, the groove is located at the geometric center of the blocking block.

[0039] Optionally, the first guiding structure includes at least one reinforcement portion, and the reinforcement portion drives other portions of the blocking component to fold and retract toward the radial inner side of the stent.

[0040] Optionally, the reinforced portion is formed by increasing the strength of a portion of the upper portion of the blocking component; or the reinforced portion is formed by other components. Optionally, the other components are reinforcing wires passing through the blocking component.

[0041] Optionally, in the radial direction of the stent, the depth of the reinforced portion occupies a part or all of the thickness of the blocking component.

[0042] Optionally, the first guiding structure includes at least one fracture site and a reinforcement site acting on the fracture site, and the blocking component is folded at the fracture site and retracted toward the radial inner side of the stent.

[0043] Optionally, the fractured portion forms a cavity area, and the reinforcement portion is arranged around the inner circumference of the cavity area; or the reinforcement portion is located on the inner circumference of the cavity area close to the inner side of the bracket.

[0044] Optionally, the two sides of the broken part are connected by a reinforcement line.

[0045] Optionally, the blocking component is a plurality of deformable blocking blocks, and a same blocking block has a plurality of first guiding structures.

[0046] Optionally, the blocking component is a plurality of deformable blocking blocks, all of which are provided with the first guiding structure, or only some of the blocking blocks are provided with the first guiding structure.

[0047] Optionally, the stent is self-expanding or balloon-expandable.

[0048] Optionally, the stent includes an inner frame defining the blood flow channel and an outer frame connected to the inner frame and positioned around the inner frame in an expanded state. The outer frame is made of a memory material suitable for self-expansion and release. The outer frame is a circumferentially spaced arm portion and / or a radially spaced outer frame extending around the inner frame.

[0049] Optionally, the stent is cut or woven and has multiple grids, and a portion or all of the grids of the stent are adaptively deformed when the stent is switched. Optionally, the blocking component is a deformable blocking block, which is embedded in the grids at corresponding positions.

[0050] Optionally, the blocking blocks are arranged in one or more groups along the axial direction of the stent, and the blocking blocks in the same group are arranged in the same grid.

[0051] Optionally, the blocking block fills up the entire grid, or only occupies a portion of the grid.

[0052] Optionally, the grid has a wide region with the largest span in the circumferential direction of the stent, and the first guide structure intersects with the wide region. Optionally, the blocking block at least fills the wide region. Optionally, the extension direction of the first guide structure is perpendicular to the extension direction of the wide region.

[0053] Optionally, along the circumference of the stent, the first guiding structure is located in the middle of the blocking block, or offset to one side.

[0054] Optionally, the first guiding structures on all the blocking blocks are offset in the same circumferential direction.

[0055] Optionally, the artificial implant further comprises:

[0056] The inner covering film is distributed around the inner peripheral wall of the stent. The blocking component is fixed to the outer side of the inner covering film. When the stent is in a released state, the blocking component protrudes outward from the stent through the corresponding grid.

[0057] Optionally, the stent includes an inner frame defining the blood flow channel and an outer frame connected to the inner frame and located outside the inner frame in an expanded state, and the inner covering is distributed around the inner circumferential wall of the inner frame.

[0058] Optionally, the artificial implant further comprises: when the stent is in a compressed state, the folded portion of the blocking component together with the inner covering film at the corresponding portion form an inward protrusion relative to the inner circumferential wall of the stent.

[0059] Optionally, from an axial perspective of the stent, at least 30% of the blocking component is located in the protrusion.

[0060] Optionally, the inner covering is a PU film. Optionally, the inner covering is bonded to the blocking component or the blocking component is directly formed on the surface of the inner covering. Optionally, the outflow side of the inner covering is spliced ​​with the leaflet and fixed to the stent.

[0061] Optionally, the inner covering film has a second guiding structure.

[0062] Optionally, the second guiding structure and the first guiding structure correspond to each other in the circumferential direction of the bracket.

[0063] Optionally, the artificial implant further comprises:

[0064] The outer covering film is distributed around the outer peripheral wall of the stent, and the blocking component is partially or completely wrapped by the outer covering film.

[0065] Optionally, the artificial implant further includes an inner covering distributed around the inner circumferential wall of the stent, and the outer covering and the inner covering are an integral structure.

[0066] Optionally, the outer membrane and the inner membrane form a pocket-shaped structure with a radial gap, the blocking component is fixed to the outer surface of the inner membrane, the blocking component is entirely within the pocket-shaped structure, or the outflow side of the blocking component is exposed outside the pocket-shaped structure.

[0067] Optionally, the inner covering film has a second guiding structure, and the second guiding structure is connected to the outer covering film.

[0068] Optionally, the outer film has a third guide structure. Optionally, the third guide structure and the inner film are connected to each other.

[0069] Optionally, the third guide structure is embedded in the first guide structure, and the embedded portion is fixedly connected to the blocking component and / or the inner covering. Optionally, the third guide structure is fixedly connected to the blocking component and / or the inner covering at least at the outflow-side edge of the outer covering. Optionally, the width of the outer covering in the axial direction of the stent corresponds to at least one complete grid, and the third guide structure is located at the midline of the corresponding grid.

[0070] Optionally, the inner covering film has a second guiding structure, and the outer covering film has a third guiding structure, and the second guiding structure and the third guiding structure are each independently a low-strength belt or a predetermined fold.

[0071] Optionally, the low-strength belt is thinner than the adjacent portion or is made of a different material.

[0072] Optionally, the predetermined fold is obtained by folding the fold back and forth and then performing heat treatment.

[0073] Optionally, the second guiding structure and the third guiding structure are respectively arranged at intervals along the circumference of the bracket.

[0074] Optionally, the number of the second guiding structures and the third guiding structures is equal to the number of grids in the axial direction of the stent or is an integer multiple of each other.

[0075] The present application also discloses an artificial implant, comprising:

[0076] The stent is a tubular structure that is radially deformable and has corresponding compressed and expanded states as it deforms;

[0077] an inner covering, distributed around the inner circumferential wall of the stent, the inner covering having a second guiding structure, wherein when the stent is in a compressed state, the inner covering folds at the second guiding structure and contracts toward the radial inner side of the stent;

[0078] The outer covering is distributed around the outer peripheral wall of the stent. The outer covering has a third guiding structure. When the stent is in a compressed state, the outer covering is folded at the third guiding structure and shrinks toward the radial inner side of the stent.

[0079] The present application discloses an artificial implant, comprising:

[0080] The stent is a tubular structure with a blood flow channel inside, and the tubular structure can be radially deformed and has corresponding compression and expansion states according to the deformation;

[0081] a valve leaflet connected to the stent and used to control a blood flow channel;

[0082] a blocking component connected to the stent and arranged along the circumference of the stent, wherein when the stent is in an expanded state, at least a portion of the blocking component protrudes outward from the outer circumference of the stent;

[0083] An actuator is connected to the stent. When the stent is transformed from the expanded state to the compressed state, the actuator is driven by the stent to act radially inwardly on at least a portion of the blocking component.

[0084] Optionally, the actuating member acts on the blocking component in a manner of line contact to press the blocking component radially inward.

[0085] Optionally, the actuator is a polymer wire, a metal wire, or a mixed wire of polymer and metal.

[0086] Optionally, the blocking component is a plurality of deformable blocking blocks, each blocking block is arranged at intervals, and the actuating member extrude a single blocking block or extrude a plurality of blocking blocks simultaneously.

[0087] Optionally, the bracket is provided with a first connection point and a second connection point spaced apart in the axial direction, the actuator is a flexible member or a deformable structure, at least one end of the actuator is connected to the first connection point, and at least the other end is connected to the second connection point.

[0088] Optionally, the bracket has a grid structure, and during the transition between different states of the bracket, the axial length of at least one grid in the grid structure changes accordingly, and the actuator responds to the change in the axial length of the grid or multiple grids.

[0089] Optionally, the actuator includes at least one traction wire, both ends of which are respectively constrained by two or more parts axially spaced apart on the stent. In the expanded state, the traction wire is relaxed to allow the sealing component to bulge outward, and in the compressed state, the traction wire is tightened to squeeze the sealing component radially inward.

[0090] Optionally, the actuator includes a plurality of traction wires and is arranged as follows:

[0091] Multiple traction wires extend in the axial direction of the stent; and / or at least one traction wire extends in the circumferential direction of the stent; and / or at least one traction wire extends in both the axial and circumferential directions of the stent; and / or a portion of at least one traction wire extends in the axial direction of the stent, and another portion extends in the circumferential direction of the stent.

[0092] Optionally, the end of the traction wire is connected to the bracket and / or other traction wires by one or more of binding, threading, winding, bonding, and welding.

[0093] Optionally, within at least one grid, a traction wire extending in the axial direction of the stent and a traction wire extending in the circumferential direction of the stent intersect with each other, and the two traction wires are positioned or movably arranged relative to the intersection.

[0094] Optionally, one of the traction wires is provided with a threading ring and the threading ring is used for threading other traction wires;

[0095] The threading ring is formed by winding the traction wire itself; or the threading ring is independently provided and connected to the corresponding traction wire.

[0096] Optionally, within a single grid, the traction wire passes through the geometric center of the grid;

[0097] The traction wires are provided in plurality and cross each other, and the crossing position is close to the geometric center of the grid.

[0098] Optionally, each grid provided with the blocking component corresponds to at least one traction wire, and the number of traction wires in each grid provided with the blocking component is the same or different.

[0099] Optionally, the blocking component is a plurality of deformable blocking blocks, the blocking blocks are arranged at intervals, and all the blocking blocks are squeezed by a traction wire.

[0100] Optionally, the stent is partially hollowed out to form a grid structure, and the radial size of the traction wire is smaller than or close to the radial size of the ribs of the grid structure.

[0101] Optionally, the artificial implant further comprises:

[0102] An inner covering film is distributed around the inner peripheral wall of the stent, the blocking component is fixed to the outer side of the inner covering film, and the stent protrudes outward from the stent through the corresponding grid when the stent is in a released state;

[0103] The outer coating is distributed around the outer peripheral wall of the stent, and the blocking component and / or the actuator are partially or completely wrapped by the outer coating.

[0104] The present application also discloses an artificial implant, comprising:

[0105] The stent is a tubular structure with a blood flow channel inside, and the tubular structure can be radially deformed and has corresponding compression and expansion states according to the deformation;

[0106] a valve leaflet connected to the stent and used to control a blood flow channel;

[0107] a blocking component connected to the stent and arranged along the circumference of the stent, wherein when the stent is in an expanded state, at least a portion of the blocking component protrudes outward from the outer circumference of the stent;

[0108] The traction wire is respectively constrained by two spaced apart positions in the axial direction of the stent. When the stent is in an expanded state, the traction wire is relaxed to allow the blocking component to bulge outward. When the stent is in a compressed state, the traction wire is relatively tight to squeeze the blocking component radially inward.

[0109] The present application also discloses an artificial implant, comprising:

[0110] The stent is a tubular structure that is radially deformable and has corresponding compressed and expanded states as it deforms;

[0111] A sealing component is connected to the stent and arranged along the circumference of the stent. When the stent is in an expanded state, at least a portion of the sealing component protrudes outward from the outer circumference of the stent. The sealing component has a slit. When the stent is in a compressed state, the sealing component is guided to fold at the slit to adapt to the deformation of the stent.

[0112] The present application also discloses a method for driving the deformation of a sealing component on an artificial implant, comprising:

[0113] An artificial implant is provided, the artificial implant comprising at least a stent and a blocking component, the blocking component being connected to the stent and arranged circumferentially along the stent, and at least a portion of the blocking component protruding outward from the outer periphery of the stent when the stent is in an expanded state;

[0114] A traction wire is passed through the stent, and when the traction wire is relaxed, the blocking component is allowed to bulge outward. When driving the blocking component to deform, the traction wire is tightened so that the traction wire acts radially inward along the stent to at least a portion of the blocking component to drive the blocking component to deform.

[0115] Optionally, tightening the traction wire fully utilizes the deformation of the stent, or

[0116] One end of the traction wire is connected to the stent, and the other end is a free end extending out of the stent and traction said free end; or

[0117] Both ends of the traction wire are free ends extending out of the stent, and one of the free ends or both free ends are pulled.

[0118] The present application also discloses a method for driving the deformation of a sealing component on an artificial implant, comprising:

[0119] An artificial implant is provided, the artificial implant comprising at least a stent and a blocking component, the blocking component being connected to the stent and arranged circumferentially along the stent, and at least a portion of the blocking component protruding outward from the outer periphery of the stent when the stent is in an expanded state;

[0120] The blocking component is provided with a slit. When the blocking component is driven to deform, the blocking component is squeezed by the deformation of the bracket so that the blocking component is guided to fold at the slit.

[0121] The method of driving the deformation of an artificial implant occlusion component of the present application can be implemented in vivo or in vitro when radially compressing a loading stent, so as to load the artificial implant into a catheter component.

[0122] The present application also discloses an intervention system, comprising:

[0123] An artificial implant, which is the artificial implant in the above technical solution and is in a compressed state;

[0124] A catheter assembly, wherein at least one tube is passed through the interior of the artificial implant and connected to the artificial implant; and at least one tube is wrapped around the periphery of the artificial implant;

[0125] The control handle connects and drives the catheter assembly.

[0126] In an interventional system, an artificial implant can be loaded into a catheter assembly using the method of the present application. Beneficial effects

[0127] The technical solution disclosed in the present application effectively reduces the incidence of paravalvular leakage by setting up a sealing component. The guiding structure or actuator can effectively drive the sealing component to adapt to the deformation of the stent, effectively overcoming the defects of access restriction and easy falling off and damage, and providing a sufficient structural basis for the optimized setting of artificial implants. BRIEF DESCRIPTION OF THE DRAWINGS

[0128] FIG1 is a schematic diagram of an artificial implant according to an embodiment;

[0129] FIG2 is an enlarged schematic diagram of the blocking component in FIG1 ;

[0130] 3 and 4 are schematic diagrams of blocking components in different embodiments;

[0131] Figures 5 and 6 are schematic diagrams of the blocking component in different states;

[0132] 7a to 9d are schematic diagrams of first guiding structures in different embodiments;

[0133] 10a to 10f are schematic diagrams of the first guiding structure in different embodiments from another perspective;

[0134] FIG11 is a schematic diagram of an artificial implant according to another embodiment;

[0135] 12 to 18 are schematic diagrams of the first guiding structure in different embodiments;

[0136] FIG19 is a schematic diagram of a bracket in one embodiment;

[0137] FIG20 is a schematic diagram of a grid of a bracket in one embodiment;

[0138] FIG21 is a schematic diagram showing the cooperation between the inner covering film and the blocking block in one embodiment;

[0139] FIG22 is a schematic diagram showing the cooperation between the inner covering film and the blocking block in another embodiment;

[0140] FIG23 is a schematic diagram of the coordination of an artificial implant from an axial perspective in one embodiment;

[0141] 24 and 25 are schematic diagrams showing the cooperation between the blocking block and the second guide structure in different embodiments;

[0142] FIG26 is a schematic diagram of an inner coating in one embodiment;

[0143] FIG27 is a schematic diagram showing the cooperation between the inner covering film and the blocking block in a compressed state;

[0144] FIG28 is a schematic diagram of an artificial implant in another embodiment;

[0145] FIG29 and FIG30 are schematic diagrams of the artificial implant in FIG28 from different perspectives;

[0146] Figure 31 is a schematic diagram of the inner and outer covering films;

[0147] Figure 32 is a schematic diagram of the third guide structure;

[0148] Figure 33 is a schematic diagram of different guide structure coordination;

[0149] FIG34 is a schematic diagram of the structure of an artificial implant in one embodiment;

[0150] FIG35a is an enlarged schematic diagram of the occluding component of the artificial implant in FIG34;

[0151] FIG35 b is a schematic diagram showing a first guide structure provided in the embodiment of FIG35 a ;

[0152] FIG35c is a schematic diagram showing a modification of the first guide structure relative to the embodiment of FIG35b;

[0153] 36 to 41 are schematic diagrams showing the cooperation between the blocking component and the actuator in different states from different perspectives;

[0154] 42 to 48 are schematic diagrams of actuator arrangements in different embodiments;

[0155] FIG49 is a schematic diagram of the structure of an artificial implant in another embodiment;

[0156] FIG50 is a schematic cross-sectional view of the artificial implant in FIG49;

[0157] 51 to 52 are schematic diagrams showing the cooperation between the blocking component and the actuating member in different states in another embodiment;

[0158] FIG53 is a schematic diagram of the loading or retrieving process of an artificial implant without an actuator;

[0159] FIG. 54 is a schematic diagram of the loading or retrieving process of an artificial implant provided with an actuator.

[0160] The reference numerals in the figures are as follows: 400, artificial implant; 401, inflow side; 402, outflow side; 403, blood flow channel; 410, stent; 411, inner frame; 4111, wide area; 412, outer frame; 4131, first connection point; 4132, second connection point; 4133. Third connection point; 4134. Limiting structure; 4135. Connection hole; 420. Blocking component; 421. First guide structure; 4210. Slit; 4212. Groove; 4213. Reinforcement portion; 422. Blocking block; 423. Reinforcement line; 430. Leaflet; 440. Inner covering; 441. Second guide structure; 442. Protrusion; 450. Outer covering; 451. Third guide structure; 460. Actuator; 4601. Traction wire; 4602. Traction wire; 4603. Traction wire; 461. Protective sleeve; 462. Threading ring; 470. Outer catheter. Modes for Carrying Out the Invention

[0161] 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.

[0162] 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.

[0163] 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.

[0164] With reference to FIG1 , the present application discloses an artificial implant, comprising:

[0165] The stent 410 is a tubular structure that can be radially deformed and has corresponding compressed and expanded states as it deforms;

[0166] The blocking component 420 is connected to the stent 410 and arranged circumferentially along the stent 410. When the stent 410 is in the expanded state, at least a portion of the blocking component 420 protrudes outward from the outer periphery of the stent 410. When the stent 410 is in the compressed state, the blocking component 420 is guided to fold to adapt to the deformation of the stent 410.

[0167] In order to adapt to the deformation of the stent 410 and to enable the blocking component 420 to obtain a more regular shape change when the stent 410 is in a compressed state, the present application implements deformation guidance for the blocking component 420. The main driving force of the guidance can come from the deformation of the stent 410. The deformation of the stent 410 can directly or indirectly act on the predetermined part of the blocking component 420 to promote folding or obtain a predetermined folded shape. When the blocking component 420 is folded, at least a part moves radially inward from the stent 410. For example, the part protruding from the stent 410 in the expanded state moves radially inward from the stent 410, so as to make full use of the internal space of the stent 410 and reduce the radial size as much as possible to facilitate loading and transcatheter interventional delivery. It can also avoid clamping or squeezing the blocking component 420 after the stent 410 switches to a compressed state, thereby reducing the risk of damage to the blocking component 420.

[0168] In some embodiments, the blocking member 420 has a first guiding structure 421. When the stent 410 is compressed, the blocking member 420 folds at the first guiding structure 421. Since the first guiding structure 421 is primarily a structural feature of the blocking member 420 itself, it can be understood that when the stent 410 is deformed, it directly acts on the blocking member 420 to guide its folding. Of course, the location of the first guiding structure 421 is the predetermined location of the blocking member 420.

[0169] The blocking component 420 achieves the effect of preventing leakage by bulging outward relative to the bracket 410. Referring to Figures 5 and 6, it can be seen that the first guide structure 421 (specifically taking the slit 4210 as an example) can improve the adaptability of the blocking component 420 to different states of the bracket 410. For example, the first guide structure 421 is a stress-weakened structure, and when the blocking component 420 switches states with the bracket 410, the first guide structure 421 or the part where it is located is more easily deformed than other parts; for another example, the first guide structure 421 is an avoidance structure, and when the blocking component 420 switches states with the bracket 410, the first guide structure 421 can provide deformation space for the deformation of the blocking component 420; for another example, the first guide structure 421 is a reinforced part, and when the blocking component 420 switches states with the bracket 410, the reinforced part drives other parts to deform. In principle, the first guide structure 421 can guide the deformation process of the blocking component 420.

[0170] The stent 410 has a grid structure. The grid structure is used to achieve switching between a compressed state and an expanded state. In a blood flow environment, the stent 410 has an axially opposite inflow side 401 and an outflow side 402. The interior of the stent 410 is a blood flow channel 403. The artificial implant also includes leaflets 430 connected to the stent 410 and used to control the blood flow channel 403. The leaflets 430 are 2, 3 or 4 pieces that cooperate with each other. The leaflets 430 are made of biological materials or polymer materials. The blocking component 420 is located on the inflow side 401 of the leaflets 430.

[0171] Referring to Figures 5 to 8b, the first guide structure 421 includes at least one fractured portion. When the stent 410 is in a compressed state, the blocking component 420 is folded at the first guide structure 421 and retracted radially inwardly toward the stent 410. The blocking component 420 is a plurality of deformable blocking blocks 422, and each blocking block 422 is arranged at intervals. In one embodiment, the blocking blocks 422 are PU foam. Due to the compressibility and self-expansion of PU foam, when it is subjected to uneven external forces on all sides, it can automatically adjust the height and thickness of the foam, and at the same time absorb blood to form self-expansion, tightly fit the valve ring, and achieve the function of preventing paravalvular leakage.

[0172] As shown in Figures 2 to 6 , the blocking block 422 can be configured in various configurations. From an axial perspective of the stent, the projected shape of the blocking block 422 can be a triangle, rhombus, semicircle, semi-ellipse, rectangle, polygon, etc. Similarly, from a circumferential perspective of the stent, the projected shape of the blocking block 422 can be a triangle, rhombus, semicircle, semi-ellipse, rectangle, polygon, etc. In terms of cross-sectional shape, referring to Figures 12 to 18, various settings of the blocking blocks are disclosed, which are mainly reflected in the protruding external shape compared to the bracket. In Figures 12, 13 and 15, the protruding external shape of the blocking block is a triangle, and the vertex positions of the triangle are different; in Figure 14, the protruding external shape of the blocking block is a trapezoid; in Figure 16, the protruding external shape of the blocking block is an irregular curved surface shape, and the end close to the inflow side is convex compared to the end close to the outflow side; in Figure 17, the protruding external shape of the blocking block is B-shaped; in Figure 18, the blocking blocks are arranged in cooperation with each other in the axial direction of the bracket, and the protruding external shape of each blocking block is a triangle, and the two are combined to form a separated B-shape.

[0173] As shown in FIG2 , the breaking portion of the first guide structure 421 is a slit 4210 formed in the blocking block 422. The extension direction of the slit 4210 aligns with the busbar of the bracket 410. The provision of the slit 4210 can relieve the deformation travel of the blocking blocks 422 on either side. The width of the slit 4210 can adjust the aforementioned effect. For example, as shown in FIG5 , the width of the slit 4210 matches the width of the frame bar of the bracket 410. As another example, as shown in other figures, the width W1 of the slit 4210 is 0 to 1 mm. When the width of the slit 4210 is 0 mm, the blocking block 422 has a structural breaking region, but the two sides of the breaking region abut against each other. In addition to the width, the depth of the slit 4210 can also adjust its working effect. For example, as shown in FIG12 , the first guide structure 421 extends along the surface of the blocking block 422. Alternatively, as shown in FIG13 , the extension direction of the first guide structure 421 is aligned with the busbar of the bracket. In addition, the depth of the first guide structure 421 can also adjust its working effect. For example, in Figure 12, along the radial direction of the bracket 410, the depth of the first guide structure 421 is less than the width of the bracket, i.e., it forms a shallow groove. In Figure 13, along the radial direction of the bracket 410, the depth W2 of the first guide structure 421 is at least half the thickness W3 of the blocking block 422.

[0174] As shown in FIG. 3 , along the radial direction of the stent 410, the depth of the slit 4210, which serves as the first guide structure, extends through the blocking block 422. The blocking block 422 is connected to the slit 4210 by other components on both sides. For example, the other component is a reinforcing wire 423 that passes through the blocking block 422. The reinforcing wire 423 can also be formed into a reinforcing fabric using various braiding methods.

[0175] The blocking block 422 may be provided with a reinforcing wire 423 that is pulled on both sides of the slit 4210. In FIG3 , for the same slit 4210, there is one reinforcing wire 423 that is passed back and forth on both sides of the slit 4210. In FIG4 , for the same slit 4210, there are multiple reinforcing wires 423, and each reinforcing wire 423 is wrapped around itself or each other to form a knot. There are multiple knots, which are arranged at intervals along the extension direction of the slit 4210. In detail, the threading path of the reinforcing wire 423 avoids the bracket 410 or wraps around the bracket 410. The reinforcing wire 423 is fixed by knotting or by using additional connectors.

[0176] Referring to FIG8a or FIG8b , the breaking portion of the first guide structure 421 is a groove 4212 provided in the blocking block 422. The opening side of the groove 4212 faces the radially outer side of the bracket 410. The depth of the groove 4212 is at least half of the thickness of the blocking block 422. Similarly, the depth of the groove 4212 can also pass through the blocking block 422, and the blocking block 422 itself has an annular structure. The groove 4212 can be located at the geometric center of the blocking block 422. The cross-sectional shape of the groove 4212 can be adapted to the shape of the blocking block, such as shown in FIG8a ; it can also be independently set to a regular geometric shape, such as the circle in FIG8b , or an ellipse, triangle, rhombus, rectangle, polygon, etc. Different parts of the blocking block 422 have different thicknesses in the radial direction of the bracket 410, and the slit 4210 at least intersects with the part with the largest thickness. In FIG8a or FIG8b, the slit 4210 axially penetrates the blocking block 422 along the support 410. In other embodiments, at least one side of the slit 4210 is closed.

[0177] The coordination between the blocking block 422 and the first guide structure 421 can vary in various ways. For example, in FIG2 , the first guide structure 421 passes through the geometric center of the blocking block 422. In FIG7a , the first guide structure 421 is eccentrically positioned relative to the geometric center of the blocking block 422. In FIG7b , the same blocking block 422 has multiple first guide structures 421. These multiple first guide structures 421 can be symmetrically or asymmetrically positioned relative to the geometric center of the blocking block 422.

[0178] 9a and 9b , the first guide structure 421 includes at least one reinforced portion 4213, which forces other portions of the blocking component to fold and retract radially inward of the stent 410. In this embodiment, the reinforced portion 4213 forces other portions of the blocking block 422 within which it is located to fold and retract radially inward of the stent 410.

[0179] In the realization of the reinforced portion 4213, the strength can be increased by increasing the strength of a part of the blocking block 422. That is, the reinforced portion 4213 and the blocking block 422 are an integral structure. It can also be divided into the same material and different material settings. For example, when the reinforced portion 4213 and the blocking block 422 are an integral structure and are made of the same material, the reinforced portion 4213 can be realized by increasing the material density of a part of the area, or increasing the thickness of a part of the area, or increasing the elasticity and / or yield strength of the material of a part of the area. For example, when the reinforced portion 4213 and the blocking block 422 are an integral structure and are made of different materials, the reinforced portion 4213 can be realized by coupling materials with different elasticity and / or yield strength in a part of the area. With reference to FIG9d, the reinforced portion 4213 can also be formed by other components, that is, the reinforced portion 4213 and the blocking block 422 are split structures. The other components can be reinforcing wires passed through the blocking block 422. In the method of using a reinforcing wire to achieve a reinforced portion 4213, the reinforced portion 4213 can be the reinforcing wire itself, or it can be a localized reinforcement achieved by the accumulation of materials in a local area caused by the insertion of the reinforcing wire. That is, the reinforcing wire can independently achieve the aforementioned reinforced portion, or it can be used in conjunction with other methods to achieve the aforementioned reinforced portion.

[0180] Similar to the fractured portion described above, the location, shape, and relationship of the reinforcement portion 4213 with the surrounding components can adjust its guiding effect with the blocking block. Referring to FIG9a, the reinforcement portion 4213 is located in the middle of the blocking block and extends on the busbar of the bracket. Referring to FIG9b, there are multiple reinforcement portions 4213 and they are symmetrically arranged relative to the geometric center of the blocking block. Referring to FIG9c, the reinforcement portion 4213 matches the peripheral shape of the blocking block. Referring to FIG10a, the depth of the reinforcement portion 4213 accounts for a portion of the thickness of the blocking block 422. Referring to FIG10b, the reinforcement portion 4213 passes through the blocking block 422, that is, the depth of the reinforcement portion 4213 accounts for the entire thickness of the blocking block 422.

[0181] The fracture site and the reinforcement site 4213 can also be arranged in coordination. Referring to FIG10c, the first guiding structure 421 includes at least one fracture site and a reinforcement site 4213 acting on the fracture site. The blocking component is folded at the fracture site and retracted toward the radial inner side of the bracket 410. The two cooperate with each other to guide the deformation process of the blocking block. The reinforcement site 4213 can be arranged on the outside or outer edge of the fracture site. Alternatively, referring to FIG10c, the fracture site forms a cavity area, and the reinforcement site 4213 is arranged around the inner circumference of the cavity area. In FIG10d, the fracture site forms a cavity area, and the reinforcement site 4213 is located on the inner circumference of the cavity area close to the inner side of the bracket, that is, the reinforcement site 4213 is located at the bottom of the fracture site.

[0182] Furthermore, the fractured portion and reinforced portion 4213 can also be coupled with reinforcing wires. Referring to FIG10e , the two sides of the fractured portion are connected by reinforcing wires. The reinforcing wires can also be threaded in different ways to further adjust their effectiveness. In FIG10f , the threading wires extend into the fractured portion.

[0183] The first guide structures 421 may be identical or distinct. Multiple blocking blocks 422 may be uniformly configured, i.e., all blocking blocks 422 may be provided with the first guide structure 421, and each first guide structure 421 may be identically configured. Multiple blocking blocks 422 may also be differentiated, such as only some blocking blocks 422 may have the first guide structure 421, or all blocking blocks 422 may be provided with the first guide structure 421, with at least one first guide structure 421 being differentiated.

[0184] Overall, the occluding block 422, constructed from PU porous foam, optimizes the skirt design of the artificial implant, leveraging the foam's compressibility to maintain the size of the delivery system. The unique shape of the first guiding structure 421 allows the foam area of ​​the occluding block 422 to fold in an orderly manner, further reducing the valve delivery size and the risk of rupture or fall of the occluding block 422 during loading and retrieval, while maintaining its effectiveness in preventing paravalvular leakage.

[0185] In terms of specific configuration, stent 410 is self-expanding and releasable. Stent 410 utilizes a memory material, such as nickel-titanium alloy. In other embodiments, stent 410 is releasable by balloon expansion. The material of stent 410 can meet the performance requirements for balloon expansion. Referring to FIG. 19 , stent 410 includes an inner frame 411 defining a blood flow channel 403 and an outer frame 412 connected to inner frame 411 and positioned around inner frame 411 in an expanded state. The outer frame 412 utilizes a memory material suitable for self-expanding and releasable. The outer frame 412 comprises circumferentially spaced arms and / or radially spaced arms extending around the outer periphery of the inner frame 411.

[0186] The support 410 is formed by cutting or weaving and has a plurality of grids. When the support 410 switches between states, a portion or all of the grids are adaptively deformed. The blocking blocks 422 are embedded in the grids at corresponding positions.

[0187] The blocking blocks 422 are arranged in one or more groups along the axial direction of the bracket 410, and the same groups are arranged in the same circle of grid. The blocking blocks 422 can fill the grid in which they are located, or the blocking blocks 422 can be set to occupy only part of the area of ​​the grid in which they are located. As shown in Figure 20, the grid has a wide area 4111 with the largest span in the circumferential direction of the bracket 410, and the first guide structure 421 intersects with the wide area 4111. The blocking blocks 422 at least fill the wide area 4111. The extension direction of the first guide structure 421 is perpendicular to the extension direction of the wide area 4111. In Figure 2, along the circumference of the bracket 410, the first guide structure 421 is located in the middle of the blocking blocks 422. In Figure 7a, along the circumference of the bracket 410, the first guide structure 421 is offset to one side. When the first guide structure 421 is offset, the first guide structures 421 on multiple blocking blocks 422 can be set to the offset direction independently, or can be set so that the first guide structures 421 on all blocking blocks 422 are offset in the same circumferential direction. The offset of each first guiding structure 421 can be set independently or uniformly.

[0188] Referring to FIG. 21 , the artificial implant further comprises:

[0189] The inner film 440 is distributed around the inner circumference of the inner frame 411. The blocking member 420 is fixed to the outer side of the inner film 440. When the support 410 is released, it protrudes outward from the support 410 through the corresponding grid. In one embodiment, the inner film 440 is a PU film. Similar to the advantages of PU foam mentioned above, PU film also has the advantages of good elasticity and adaptability to inward folding. The preparation method of PU film can refer to the following settings:

[0190] The implantable PU particles (i.e., polyurethane) are dissolved in dimethylformamide (DMF) solvent to obtain a PU solution (i.e., polyurethane solution), wherein the polyurethane content in the polyurethane solution is 5% to 20% (w / v); when the PU particles are dissolved, a mechanical stirrer is used to accelerate the dissolution rate at room temperature or heated (18 to 90° C.);

[0191] Pour a certain amount of PU solution into a flat mold, and place the flat mold in an oven at 30-70°C for 7-24 hours to produce a PU film. The thickness of the film can be adjusted according to the solution concentration and the height of the solution after pouring into the mold, and the thinnest can reach 0.02mm.

[0192] As shown in FIG. 27 , when the stent 410 is in a compressed state, the folded portion of the sealing member 420, together with the inner coating 440 at the corresponding portion, forms an inwardly directed protrusion 442 relative to the inner circumferential wall of the stent 410. From an axial perspective of the stent 410, at least 30% of the sealing member 420 is located within the protrusion 442. The inner coating 440 is bonded to the sealing member 420 or formed directly on the surface of the inner coating 440. In terms of molding, the two can be produced and assembled separately, or they can be integrally processed. For example, the preparation method for integrally molding a PU film and PU foam is as follows:

[0193] The implantable polyurethane (PU) particles are dissolved in a DMF solvent to obtain a PU solution (PU particle content is 5% to 20% (w / v)), and the PU solution is mixed with sodium chloride to obtain a premix for preparing the foam, wherein the diameter of the sodium chloride is about 5 to 500 microns and the mass fraction of the sodium chloride in the premix is ​​50% to 80%;

[0194] The premix is ​​filled into a mold and compacted. The shape of the mold can be changed according to the design of the plugging component;

[0195] Heat the PU film (40-80°C), then spread it on the mold surface and let it sit or put it in an oven for a certain period of time;

[0196] 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.

[0197] In the embodiments shown in Figures 23 to 27 , in the embodiment where the inner covering film 440 includes a second guiding structure 441, the second guiding structure 441 can be implemented simultaneously during the processing of the inner covering film 440. For example, the flat mold for containing the PU solution mentioned above can be replaced with a mold of a predetermined shape. The PU film produced from this mold will then include the second guiding structure 441. The second guiding structure 441 can also be implemented independently of the processing of the inner covering film 440. For example, a flat inner covering film 440 can be processed into a predetermined shape, placed in an oven at a predetermined temperature and maintained for a predetermined time to obtain the inner covering film 440 with the second guiding structure 441. In specific implementations, the second guiding structure 441 can take various forms, such as a three-dimensional structure that is raised or recessed relative to the plane of the inner covering film 440; an area that is weakened or strengthened relative to the surrounding area; and so on. For example, in Figure 23 , the second guiding structure 441 is a crease on the inner covering film 440.

[0198] The sealing component and the inner covering film are bonded or processed as one piece, which can obtain a greater peel strength. Therefore, when the sealing component is exposed, it is not easy to detach even if it contacts and rubs against the catheter component or internal tissue, thereby avoiding the safety risk of detachment of the sealing component.

[0199] In terms of the coordination relationship between the inner covering 440 and other components, the outflow side 402 of the inner covering 440 is spliced ​​with the leaflet 430 and fixed to the stent 410. In FIG21 , the inflow side 401 of the inner covering 440 extends to the end of the inflow side 401 of the stent 410. In FIG22 , the inflow side 401 of the inner covering 440 is turned outward to wrap the end of the inflow side 401 of the stent 410. The turning outward wrapping is a complete wrapping, or a partial wrapping at intervals. In the embodiment in which the inner covering 440 turns outward to wrap the stent 410, the turning outward portion of the inner covering 440 can extend to the radial inner side of the blocking component, or can cover the radial outer side of the blocking component. When the turning outward portion of the inner covering 440 covers the radial outer side of the blocking component, the turning outward portion of the inner covering 440 can be understood as the outer covering 450 mentioned below.

[0200] With reference to Figures 23 to 27 , the inner coating 440 is provided with a second guide structure 441. The second guide structure 441 corresponds to the first guide structure 421 in the circumferential direction of the bracket 410. With regard to the matching relationship between the second guide structure 441 and the blocking block 422, reference can be made to Figure 24 , where the shapes of the two match each other. Reference can also be made to Figure 25 , where the two are independently arranged. The second guide structure 441 can be arranged to face the radial inner side of the bracket 410, or can be arranged to face the radial outer side of the bracket 410, or can be arranged in both directions, as shown in Figure 26 . In Figure 25 , a connecting piece is provided between the second guide structure 441 and the blocking block 422. Specifically, it can be a reinforcing wire 423 or a reinforcing fabric. The connection position between the connecting piece and the blocking block 422 can be located inside the first guide structure 421 or elsewhere.

[0201] Referring to FIG. 28 , the artificial implant further comprises:

[0202] The outer coating 450 is distributed around the outer peripheral wall of the stent 410 , and a part or the whole of the blocking component 420 is wrapped by the outer coating 450 .

[0203] The outer coating 450 can be provided independently, or, as shown in FIG29 , the outer coating 450 and the inner coating 440 can be integrally formed. When the outer coating 450 and the inner coating 440 are integrally formed, the outer coating 450 can be understood as being formed by the inner coating 440 being turned outward to wrap around the inflow side 401 end of the stent 410 and extending along the outer circumference of the blocking member 420. As can be seen from FIG29 and FIG30 , the outer coating 450 and the inner coating 440 together form a pocket-like structure with a radial gap, and the blocking member 420 is fixed to the outer surface of the inner coating 440. The blocking member 420 is entirely within the pocket-like structure, or the outflow side 402 of the blocking member 420 is exposed outside the pocket-like structure.

[0204] The outer film 450 can be provided independently of the inner film 440 or the blocking block 422. Alternatively, as shown in FIG31 , the second guide structure 441 and the outer film 450 can be interconnected. The interconnection can be achieved by reinforcing wires 423 or reinforcing fabrics.

[0205] Referring to FIG. 32 , the outer coating 450 includes a third guide structure 451. The third guide structure 451 can be positioned radially inward of the stent 410, radially outward of the stent 410, or in both directions. The third guide structure 451 and the first guide structure 421 can be positioned in a corresponding manner, for example, embedded within the first guide structure 421. The outer coating 450 has an axial width corresponding to at least one complete grid line around the stent 410, with the third guide structure 451 located at the midline of the corresponding grid line.

[0206] As shown in FIG. 33 , the third guide structure 451 and the inner covering film 440 are interconnected. The interconnection is achieved by bonding or sewing. When sewing is used, it can be achieved by using a reinforcing wire 423 or a reinforcing fabric. In FIG. 33 , the third guide structure 451 is embedded in the first guide structure 421. During the embedding process, the outer covering film 450 is partially folded to form the third guide structure 451. The size of the third guide structure 451 is smaller than that of the first guide structure 421 to ensure the normal operation of the first guide structure 421. The embedded portion is fixedly connected to the blocking component 420 and / or the inner covering film 440. The third guide structure 451 is fixedly connected to the blocking component 420 and / or the inner covering film 440 at least at the edge of the outflow side 402 of the outer covering film 450. At the connection position, the reinforcing wire 423 can be connected to both ends of the second guide structure 441 to ensure the normal operation of the second guide structure 441.

[0207] In terms of the implementation of each guiding structure, the inner coating 440 has a second guiding structure 441, and the outer coating 450 has a third guiding structure 451. The second guiding structure 441 and the third guiding structure 451 are each independently a low-strength belt or a pre-shaped fold. The low-strength belt has a thinner thickness than the adjacent part or is made of a different material. The pre-shaped fold is obtained by folding itself back and forth and then heat-treating it. The low-strength belt or the pre-shaped fold can also be obtained by the preset shape of the mold during the production process. The second guiding structure 441 and the third guiding structure 451 are respectively arranged at intervals along the circumference of the bracket 410. The number of the second guiding structure 441 and the third guiding structure 451 is equal to the number of grids in the axial direction of the bracket 410 or is an integer multiple of each other.

[0208] In combination with the features of the first guide structure in the above embodiments, an embodiment of the present application further discloses an artificial implant, comprising:

[0209] The stent is a tubular structure that can be radially deformed and has corresponding compressed and expanded states as the deformation progresses;

[0210] The blocking component is connected to the stent and arranged along the circumference of the stent. When the stent is in an expanded state, at least a portion of the blocking component protrudes outward from the outer circumference of the stent. The blocking component has a slit. When the stent is in a compressed state, the blocking component is guided to fold at the slit to adapt to the deformation of the stent.

[0211] In order to implement loading or recovery of an artificial implant, an embodiment of the present application further discloses a method for driving the deformation of a sealing component on an artificial implant, which can be implemented by the guide structures of the above embodiments. For example, the method includes:

[0212] An artificial implant is provided, the artificial implant comprising at least a stent and a blocking component, the blocking component being connected to the stent and arranged circumferentially along the stent, and at least a portion of the blocking component protruding outward from the outer periphery of the stent when the stent is in an expanded state;

[0213] The blocking component is provided with a slit. When the blocking component is driven to deform, the blocking component is squeezed by the deformation of the bracket so that the blocking component is guided to fold at the slit.

[0214] It is not difficult to understand from the above description that an embodiment of the present application further discloses an artificial implant, comprising:

[0215] The stent 410 is a tubular structure that can be radially deformed and has corresponding compressed and expanded states as it deforms;

[0216] An inner coating 440 is distributed around the inner circumferential wall of the stent 410. The inner coating 440 has a second guiding structure 441. When the stent 410 is in a compressed state, the inner coating 440 is folded at the second guiding structure 441 and indented toward the radial inner side of the stent 410.

[0217] The outer coating 450 is distributed around the outer peripheral wall of the stent 410 and has a third guiding structure 451 . When the stent 410 is in a compressed state, the outer coating 450 is folded at the third guiding structure 451 and contracts toward the radial inner side of the stent 410 .

[0218] An embodiment of the present application further discloses an interventional system, comprising:

[0219] An artificial implant, which is any of the above embodiments and is in a compressed state;

[0220] A catheter assembly, wherein at least one tube is disposed inside the artificial implant and connected to the artificial implant; and at least one tube is wrapped around the periphery of the artificial implant;

[0221] Control handle to connect and drive the catheter assembly.

[0222] With reference to Figures 34 to 41 , an embodiment of the present application further discloses an artificial implant, comprising:

[0223] The stent 410 is a tubular structure that can be radially deformed and has corresponding compressed and expanded states as it deforms;

[0224] The blocking member 420 is connected to the stent 410 and arranged along the circumference of the stent 410. When the stent 410 is in the expanded state, at least a portion of the blocking member 420 protrudes from the outer circumference of the stent 410.

[0225] Actuator 460 is connected to stent 410. Driven by stent 410, actuator 460 acts radially inwardly along stent 410 to at least a portion of blocking member 420 during the transition from an expanded state to a compressed state, thereby guiding blocking member 420 to fold. In this embodiment, deformation of stent 410 indirectly affects blocking member 420 via actuator 460. While deformation of stent 410 can also compress blocking member 420, actuator 460 in this embodiment primarily guides folding.

[0226] The actuator 460 can act in a line contact manner to squeeze the blocking member 420 into the interior space of the bracket 410. This line contact method concentrates the action area, which facilitates guiding folding. In other embodiments, the contact area between the actuator 460 and the blocking member 420 can be increased, such as by using surface contact or more dense line contact (e.g., mesh contact).

[0227] In some embodiments, part or all of the actuator 460 is made of a developable material or has a developable mark to indicate the spatial position and posture of the artificial implant. It can also reflect the morphological changes of the actuator 460 itself and the blocking component 420, and can provide real-time reference in conjunction with medical imaging equipment during the operation.

[0228] Stent 410 can be released by self-expanding or by balloon expansion using a fluid-filled balloon. Depending on the release control requirements, a wire-controlled approach can also be employed. Specifically, stent 410 is connected to the interventional delivery system via a pullwire. By tightening or loosening the pullwire at the proximal end, the release process of stent 410 can be precisely controlled, as well as stent 410 retraction can be performed. In this approach, the pullwire can also be coupled with actuator 460, for example, the pullwire and actuator 460 can be interconnected or even formed as the same component. In this case, actuator 460 can also be used to drive the deformation of stent 410.

[0229] Stent 410 has an axially opposed inflow side 401 and an outflow side 402 in a blood flow environment. The interior of stent 410 defines a blood flow channel 403. The artificial implant further includes leaflets 430 connected to stent 410 and configured to control blood flow channel 403. Leaflets 430 may comprise two, three, or four cooperating leaflets. Leaflets 430 may be made of a biomaterial or a polymer. A sealing member 420 is located on the inflow side 401 of leaflets 430. When stent 410 is in an expanded state, sealing member 420 prevents peripheral leakage by bulging outward relative to stent 410 (see Figures 38 and 40 ). When stent 410 is in a compressed state, sealing member 420 is squeezed to conform to the shape of stent 410 (see Figures 39 and 41 ). This squeezing process may be assisted by actuator 460, which may also respond to changes in the stent's state (see Figures 36 and 37 ).

[0230] Actuating member 460 compresses blocking member 420 by acting radially inward along stent 410, at least on a portion of blocking member 420. In some embodiments, the actuating portion preferably passes through the geometric center of the radial projection of blocking member 420. As shown in FIG36 , when stent 410 has a lattice structure, the actuating portion passes through wide region 4111, where the lattice structure has its largest circumferential dimension.

[0231] When the actuator 460 acts in line contact, referring to FIG36 or FIG42, the contact form of the line contact is a straight line (or curve); referring to FIG43 and FIG44, the contact form of the line contact is a cross; referring to FIG45, the contact form of the line contact is radial; referring to FIG46, the contact form of the line contact is a grid.

[0232] Stent 410 has a grid structure. As stent 410 transitions between different states, the axial length of at least one grid in the grid structure changes accordingly. Actuator 460 responds to this change in grid axial length. As shown in FIG. 48 , actuator 460 can also respond to changes in the axial lengths of multiple grids.

[0233] There are various ways to implement the effects of actuator 460. For example, actuator 460 may be a deformable component or assembly that adjusts its shape in response to the state of bracket 410. In another example, actuator 460 may be a transmission component or assembly that transmits the state change of bracket 410 to blocking component 420.

[0234] The actuator 460 includes at least one traction wire, the ends of which are respectively constrained by two or more axially spaced locations on the stent 410. In the expanded state, the traction wire is relaxed to allow the blocking component to bulge outward (see Figures 36, 38, and 40). In the compressed state, the traction wire is tightened to radially squeeze the blocking component inward (see Figures 37, 39, and 41). Figures 36 and 37 illustrate the details of the actuator 460 more simply, without showing the blocking component or blocking block. In Figures 38 to 41, the blocking component is shown in the form of a blocking block 422. Preferably, the actuator 460 is a polymer wire, a metal wire, or a mixed wire of polymer and metal. As shown in Figure 35a, the radial dimension of the actuator 460 is close to the radial dimension of the stent ribs to withstand greater torque. As shown in Figure 36, the radial dimension of the actuator 460 is smaller than the radial dimension of the stent ribs to concentrate stress and optimize the squeezing effect.

[0235] The blocking member 420 comprises a plurality of deformable blocking blocks 422, each of which is arranged at intervals. In terms of the coordination with the blocking member 420, as shown in FIG35a , the actuator 460 drives the movement of each blocking block 422, which can accurately control the state change of the blocking block 422.

[0236] Referring to FIG. 35b , the first guide structure mentioned in the above embodiments can also be used in conjunction with actuator 460 . For example, if first guide structure 421 and actuator 460 correspond in position, when the first guide structure utilizes slit 4210 , at least a portion of actuator 460 (bold black line in the figure) can extend through slit 4210 , and both ends of actuator 460 can be attached to bracket 410 .

[0237] 35c, the actuator 460 can also be staggered with the first guide structure to guide the folding of the blocking block 422 from different positions. For example, there are two slits 4210 arranged on both sides of the actuator 460 (bold black lines in the figure) along the circumference of the stent.

[0238] Also referring to FIG47 , the actuator 460 synchronously drives the movement of multiple blocking blocks 422. This setting can reduce the number of moving parts and optimize the overall state control of the artificial implant. In order to better control the blocking block 422, the blocking block 422 fills the grid in which it is located and within a single grid, the traction wire passes through the geometric center of the grid. The above methods can also cooperate with each other. Referring to FIG46 , a part of the actuator 460 drives a separate blocking block (in order to more concisely show the setting details of the actuator 460, the blocking component or blocking block is not shown in FIG46 ) to move, and the other part synchronizes the movement of multiple blocking blocks.

[0239] Regarding the cooperation with the bracket 410, as shown in FIG37 , the bracket 410 is provided with a first connection point 4131 and a second connection point 4132 spaced apart in the axial direction, and each connection point is selected at a position that is easy to restrain the brake member.

[0240] The actuator 460 is a flexible member or a deformable structure. At least one end of the actuator 460 is connected to a first connection point 4131, and at least the other end is connected to a second connection point 4132. For example, referring to the embodiments shown in Figures 36 and 37 , the first connection point 4131 and the second connection point 4132 are respectively located at the grid vertices of the bracket 410. As another example, in Figure 42 , the bracket 410 is provided with a first connection point 4131, a second connection point 4132, and a third connection point 4133 spaced apart in the axial direction. The first connection point 4131 is located at a grid vertex of the bracket 410, and the second connection point 4132 and the third connection point 4133 are located on the ribs of the bracket 410. The second connection point 4132 and the third connection point 4133 are aligned or offset in the circumferential direction of the bracket 410.

[0241] It is understandable that the connection points need to meet certain limiting effects in their settings. For example, as shown in FIG36 , the connection points are the grid vertices of the bracket 410; for another example, as shown in FIG46 , the connection points are the connection holes 4135 opened on the bracket 410; for another example, as shown in FIG46 , the connection points are the notches or wavy limiting structures 4134 on the bracket 410. As can be seen from the above description, the role of the connection points is to limit the positional relationship between the actuator 460 and the bracket 410, but it does not necessarily limit the spatial position of the actuator 460. For example, in FIG46 , the connection point is in the form of a connection hole 4135 and the actuator 460 is a traction wire, which can be movably passed through the connection hole 4135 to adjust its own axial position. For another example, in FIG42 to FIG45 , the connection points of the actuator 460 and the bracket 410 are bound to each other, thereby limiting their own spatial position and achieving a fixed connection. Therefore, in terms of connection methods, the end of the actuator 460 is connected to the bracket 410 and / or other actuators 460 by one or more of binding (refer to FIG. 42 ), penetration (refer to FIG. 46 , the bracket 410 has a connection hole 4135), winding (through the structural gap of the bracket 410 itself), bonding, and welding.

[0242] Referring to FIG. 36 , actuator 460 is connected to bracket 410 via a protective sheath 461 to reduce wear and distribute stress. Protective sheath 461 and / or actuator 460 can be made of a wear-resistant and / or self-lubricating polymer material. In the embodiment shown in the accompanying drawings, actuator 460 includes multiple traction wires and can be arranged in a variety of configurations.

[0243] For example, as shown in FIG42 , multiple traction wires extend in the axial direction of the stent 410. The axially extending traction wires can respond to changes in the axial length of the stent 410, thereby achieving a driving effect. Multiple traction wires arranged in parallel can improve the stability of the driving.

[0244] As another example, as shown in Figures 43 to 45, at least one traction wire extends in the circumferential direction of the stent 410. The traction wires can cooperate with each other to achieve the effect on the blocking component. For example, in Figure 43, the circumferentially extending traction wire can limit the lower end position of the traction wires extending in the two axial directions, and the position of the traction wire can be stably set even if it is connected to a rib with a smooth transition. For example, in Figure 44, in addition to being able to determine the lower end position of the traction wire extending in the axial direction, the circumferentially extending traction wire can also participate in responding to the state change of the stent 410 and squeeze the blocking component together with the traction wire extending in the axial direction in cooperation with the traction wire extending in the axial direction; it can be understood that the circumferentially extending traction wire can change the position of cooperation with the axially extending traction wire by adjusting its length (as shown in Figure 45).

[0245] As another example, as shown in FIG46 , at least one traction wire extends partially in the axial direction of stent 410, and another partially in the circumferential direction of stent 410. In this embodiment, the circumferentially extending traction wire not only coordinates with the axially extending traction wire in responding to state changes of stent 410 but also provides a structural foundation for synchronizing multiple occlusion blocks.

[0246] It is also understandable that the traction wire may be configured such that at least one traction wire extends in both the axial and circumferential directions of the stent 410 ; for example, the traction wire extends obliquely relative to the axis of the stent.

[0247] The above-mentioned configuration methods can be implemented independently or in coordination with each other.

[0248] When multiple traction wires are present, they can be independently arranged or coordinated with each other. Referring to the embodiment shown in FIG. 46 , within at least one grid, a traction wire extending axially of the stent 410 intersects with a traction wire extending circumferentially of the stent 410. The intersection is located near the geometric center of the grid. The two traction wires can be positioned relative to the intersection to increase load-bearing strength. Alternatively, as shown in FIG. 46 , the two traction wires can be flexibly arranged relative to the intersection. A threading ring 462 is provided on one traction wire, through which other traction wires are threaded. Threading ring 462 can be formed by winding around the traction wire itself, or it can be independently arranged and connected to the corresponding traction wire. For example, threading ring 462 can be a separate polymer ring or metal ring. The connection between threading ring 462 and the traction wire can be achieved through penetration, welding, bonding, or winding.

[0249] With reference to the embodiment shown in FIG. 46 , each grid having a blocking member 420 corresponds to at least one traction wire, and the number of traction wires within each grid having a blocking member 420 may be the same or different. When calculating the number of traction wires within each grid having a blocking member 420, the number of traction wires that cooperate with the blocking member 420 within that grid should be considered. Traction wires that pass through a grid on their extension path but do not cooperate with the blocking member 420 within that grid are not included in the aforementioned number of traction wires.

[0250] The extension path of the traction wire can be set in various ways. As shown in Figure 46, the traction wire 4601 extends axially from the grid vertex of the stent 410 through the connecting hole 4135 on the left side, and then extends circumferentially through the threading ring 462. It can be set as follows:

[0251] Method 1: Connecting to the stent 410 nearby to complete the constrained path, for example, as shown by the dotted line in FIG. 46 , where one end of the traction wire is connected to the limiting structure 4134 on the stent 410 ;

[0252] Method 2: After extending to the connection hole 4135 on the right side of FIG. 46 , the wire is extended along the path of the traction wire 4602 and connected to the connection hole 4135 at the grid vertex or top side of the stent;

[0253] Method 3: After extending to the connection hole 4135 on the right side of FIG. 46 , it extends to the next grid along the path of the traction wire 4603 and cooperates with another traction wire.

[0254] In combination with the above, it can be seen that there are a variety of flexible ways of matching between the actuator 460, the bracket 410 and the blocking component 420. Referring to the embodiment shown in Figure 47, the blocking component is a plurality of deformable blocking blocks 422, each blocking block 422 is arranged at intervals, and all the blocking blocks 422 are squeezed by a traction wire. In this embodiment, a traction wire refers to a continuous constraint path, and does not limit the actual number of components of the traction wire. For example, a traction wire can be formed by connecting multiple traction components. The solution in this embodiment can be understood as the traction wire 4603 in Figure 46 wrapping around the bracket for a week and then turning into an axial extension through the connecting hole 4135 or the vertices of the bracket grid. On the basis of this embodiment, each grid or multiple grids can also be independently provided with or without an axial traction wire. The matching relationship between the traction wires can be achieved through a traction ring or other methods.

[0255] One or both ends of the traction wire can also extend out of the stent as a free end, and the rest of the traction wire is circuitously guided into the grid structure of the stent. After driving the blocking component to deform, the traction wire can also be removed. It is not strictly limited that the traction wire enters the body with the stent during use.

[0256] The blocking component and the actuator may be provided on a variety of brackets, such as the bracket 410 shown in FIG. 47 to FIG. 48 , the bracket 410 shown in FIG. 49 , and other forms of deformable brackets.

[0257] With reference to the embodiments shown in FIG. 49 to FIG. 52 , the artificial implant further comprises:

[0258] The inner covering 440 is distributed around the inner circumference of the stent 410. The blocking member 420 is fixed to the outer side of the inner covering 440. When the stent 410 is released, the blocking member 420 protrudes from the stent 410 through the corresponding grid.

[0259] The outer coating 450 is distributed around the outer peripheral wall of the stent 410 , and a portion or the entirety of the blocking component 420 and / or the actuator 460 is wrapped by the outer coating 450 .

[0260] The inner coating 440 and the outer coating 450 can be made of PU film, and the sealing component 420 can be made of PU foam. PU film and PU foam have the advantages of good elasticity, easy deformation and the ability to restore to their original shape. The inner coating and the outer coating can adapt to the state changes of the stent, and the sealing component 420 can change its own spatial volume to adapt to the state changes of the stent. Corresponding structures can also be provided on the sealing component 420, such as grooves or slits or local reinforcements. The above structures can be implemented independently to improve the compliance of the sealing component 420, or they can optimize the matching relationship between the sealing component and the actuator, such as keeping the actuator in a specific position to improve the driving effect. Similarly, corresponding guide structures can also be provided on the inner coating and the outer coating. For example, as shown in Figures 51 and 52, the inner coating 440 is provided with a guide structure to improve its own adaptability to changes in the state of the stent. The guide structure is a fold and is aligned with the sealing component 420, and can be further combined with the second guide structure and the third guide structure mentioned above.

[0261] The inflow-side ends of the outer coating 450 and inner coating 440 can be independently configured, as shown in Figure 49 . Alternatively, as shown in Figure 50 , the two can be connected. When connected and made of the same material, they can also form a single unit. In this case, the outer coating 450 is understood to be formed by turning the inner coating 440 outwards to the outside of the stent. Furthermore, the outer coating 450 and inner coating 440 can also be implemented separately. For example, Figures 51 and 52 only illustrate cross-sections of the artificial implant in different states when the inner coating 440 is provided alone.

[0262] It is understandable that an embodiment of the present application further discloses an interventional system, including:

[0263] An artificial implant, which is the artificial implant in the above technical solution and is in a compressed state;

[0264] A catheter assembly, comprising at least one tube extending through the interior of the artificial implant and connecting the artificial implant; and at least one tube (e.g., the outer catheter 470 shown in FIG. 53 and FIG. 54 ) wrapping around the outer periphery of the artificial implant.

[0265] Control handle to connect and drive the catheter assembly.

[0266] 53 , which illustrates an embodiment without an actuator, indicates that during the loading or retrieval of the artificial implant 400 into the outer catheter 470 of the delivery system, the outer catheter 470 must be pushed relative to the artificial implant 400, gradually enveloping the artificial implant 400. During this process, the stent 410 is radially compressed, causing the blocking member 420 to further protrude outward from the outer periphery of the stent 410. Friction between the outer catheter 470 and the protruding blocking member 420 can easily damage the blocking member 420 or even cause it to fall off the stent 410. Referring to FIG. 54 , when the stent 410 is radially compressed, the actuator 460 exerts a radially inward force on the blocking member 420, forcing the blocking member 420 into the interior space of the stent 410, thereby reducing the risk of damage or fallout of the blocking member during loading or retrieval ( FIG. 54 shows multiple blocking members 420 and actuators 460; for simplicity, two at different locations are shown; not all are shown).

[0267] In order to implement loading or retrieving an artificial implant, an embodiment of the present application further discloses a method for driving the deformation of a sealing component on an artificial implant, which can be implemented by the actuators of the above embodiments. For example, the method includes:

[0268] An artificial implant is provided, the artificial implant comprising at least a stent and a blocking component, the blocking component being connected to the stent and arranged circumferentially along the stent, and at least a portion of the blocking component protruding outward from the outer periphery of the stent when the stent is in an expanded state;

[0269] A traction wire is threaded through the stent. When the traction wire is relaxed, the occluding component is allowed to bulge outward. When the occluding component is deformed, the traction wire is tightened so that the traction wire acts radially inward along the stent to at least a portion of the occluding component, thereby causing the occluding component to deform. When the traction wire is tightened, the deformation of the stent can be fully utilized. Alternatively, one end of the traction wire can be connected to the stent, and the other end can be a free end extending from the stent. When the traction wire is tightened, the free end can be pulled. Alternatively, both ends of the traction wire can be free ends extending from the stent, and when the traction wire is tightened, one or both free ends can be pulled.

[0270] For other specific implementation processes, please refer to the above description and will not be repeated here.

[0271] 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.

[0272] 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, Comprising: A stent, which is a tubular structure that can be radially deformed and has corresponding compressed and expanded states along with the deformation. A sealing component, which is connected to the stent and arranged circumferentially along the stent. When the stent is in the expanded state, at least a part of the sealing component protrudes outward from the outer periphery of the stent. When the stent is in the compressed state, the sealing component is guided to fold to adapt to the deformation of the stent.

2. The artificial implant according to claim 1, wherein The deformation of the stent acts on a predetermined part of the sealing component to guide the folding of the sealing component. When folding, at least a part of the sealing component moves radially inward of the stent.

3. The artificial implant according to claim 2, wherein, The deformation of the stent directly acts on the sealing component and / or indirectly acts on the sealing component.

4. The artificial implant according to claim 1, characterized in that, The sealing component is provided with a first guiding structure. When the stent is in the compressed state, the sealing component folds at the first guiding structure.

5. The artificial implant according to claim 1, characterized in that, The artificial implant further comprises: An actuator, which is connected to the stent. During the process of the stent changing from the expanded state to the compressed state, the actuator acts radially inward on at least a part of the sealing component along the stent to guide the folding of the sealing component.

6. The artificial implant according to claim 5, characterized in that, The stent has a grid structure. During the process of the stent changing between different states, the axial length of at least one grid in the grid structure changes correspondingly, and the actuator responds to the axial length change of this grid or multiple grids.

7. The artificial implant according to claim 4, characterized in that, The first guiding structure at least includes a fracture site. When the stent is in the compressed state, the sealing component folds at the fracture site and sinks radially inward of the stent.

8. The artificial implant according to claim 7, characterized in that, The sealing component is composed of multiple deformable sealing blocks, and the sealing blocks are arranged at intervals. The fracture site is a slit opened in the sealing block.

9. The artificial implant according to claim 8, wherein, The width of the slit is 0 - 1 mm.

10. The artificial implant according to claim 8, characterized in that, The sealing block is made of PU foam.

11. The artificial implant according to claim 8, characterized in that, The extending direction of the slit is consistent with the generatrix of the stent.

12. The artificial implant according to claim 8, characterized in that, Along the radial direction of the stent, the depth of the slit is at least half of the thickness of the sealing block.

13. The artificial implant according to claim 8, wherein Along the radial direction of the stent, the depth of the slit penetrates the sealing block, and the sealing block is kept connected on both sides of the slit by other components.

14. The artificial implant according to claim 13, characterized in that, The other components are reinforcing wires threaded through the sealing block.

15. The artificial implant according to claim 8, characterized in that, Different parts of the sealing block have different thicknesses in the radial direction of the stent, and the slit intersects at least with the part with the largest thickness.

16. The artificial implant according to claim 8, wherein, The slit penetrates the sealing block along the axial direction of the stent, or at least one side is a closed side.

17. The artificial implant according to claim 8, characterized in that, Reinforcing wires are arranged in the sealing block and pulled on both sides of the slit.

18. The artificial implant according to claim 17, wherein The threading path of the reinforcing wire avoids the stent or winds around the stent.

19. The artificial implant according to claim 17, characterized in that, The reinforcing wire is fixed by knotting or by additional connecting parts.

20. The artificial implant according to claim 17, characterized in that, For the same slit, there is one reinforcing wire that reciprocally threads through both sides of the slit.

21. The artificial implant according to claim 17, characterized in that, For the same slit, there are multiple reinforcing wires, and each reinforcing wire winds itself or with each other to form knots.

22. The artificial implant according to claim 21, characterized in that, There are multiple knots, which are arranged at intervals along the extending direction of the slit.

23. The artificial implant according to claim 8, characterized in that, The fracture site is a groove opened in the sealing block.

24. The artificial implant according to claim 23, characterized in that, The opening side of the groove faces the outer side in the radial direction of the stent.

25. The artificial implant according to claim 23, wherein, The depth of the groove is at least half of the thickness of the sealing block.

26. The artificial implant according to claim 23, characterized in that, The depth of the groove penetrates the sealing block, and the sealing block itself is in an annular structure.

27. The artificial implant according to claim 23, characterized in that, The groove is at the geometric center position of the sealing block.

28. The artificial implant according to claim 4, characterized in that, The first guiding structure includes at least one strengthening part, and the strengthening part drives other parts of the plugging component to fold and collapse radially inwards towards the stent.

29. The artificial implant according to claim 28, characterized in that, The strengthening part is formed by increasing the strength of a partial area on the plugging component; or the strengthening part is formed by other components.

30. The artificial implant according to claim 29, characterized in that, The other component is a strengthening wire threaded through the plugging component.

31. The artificial implant according to claim 28, wherein, In the radial direction of the stent, the depth of the strengthening part occupies a part or all of the thickness of the plugging component.

32. The artificial implant according to claim 4, characterized in that, The first guiding structure includes at least one breaking part and a strengthening part acting on the breaking part, and the plugging component folds at the breaking part and collapses radially inwards towards the stent.

33. The artificial implant according to claim 32, wherein, The breaking part forms a cavity area, and the strengthening part is arranged around the inner peripheral surface of the cavity area; or the strengthening part is located on the inner peripheral surface of the cavity area close to the inner side of the stent.

34. The artificial implant according to claim 32, wherein, Both sides of the breaking part are connected by a strengthening wire.

35. The artificial implant according to claim 4, wherein The plugging component is a plurality of deformable plugging blocks, and there are multiple first guiding structures on the same plugging block.

36. The artificial implant according to claim 4, characterized in that, The plugging component is a plurality of deformable plugging blocks, and the first guiding structure is provided on all the plugging blocks, or only on some of the plugging blocks.

37. The artificial implant according to claim 4, wherein, The artificial implant further includes: An actuating member, connected to the stent. During the process of the stent changing from the expanded state to the compressed state, the actuating member acts radially inwards on at least a part of the plugging component under the drive of the stent to guide the plugging component to fold, and the actuating member is arranged corresponding to or misaligned with the first guiding structure.

38. The artificial implant according to claim 37, characterized in that, The first guiding structure includes at least one breaking part, and at least a part of the actuating member extends through the breaking part when the stent is in the expanded state.

39. The artificial implant according to claim 1, characterized in that, The stent is formed by cutting or weaving and has a plurality of meshes, and some or all of the meshes deform adaptively when the stent switches states.

40. The artificial implant according to claim 39, wherein, The plugging component is a deformable plugging block, and the plugging block is embedded in the correspondingly positioned mesh.

41. The artificial implant according to claim 40, characterized in that, The plugging blocks are arranged in one or more groups along the axial direction of the stent, and the groups are circumferentially distributed within the same circle of meshes.

42. The artificial implant according to claim 40, characterized in that, The plugging block fills the mesh where it is located, or only occupies a partial area of the mesh where it is located.

43. The artificial implant according to claim 40, characterized in that, The plugging component is provided with a first guiding structure. When the stent is in the compressed state, the plugging component folds at the first guiding structure; The mesh has a wide area with the largest span in the circumferential direction of the stent, and the first guiding structure intersects with the wide area.

44. The artificial implant according to claim 43, wherein, The plugging block fills at least the wide area.

45. The artificial implant according to claim 43, wherein, The extending direction of the first guiding structure is perpendicular to the extending direction of the wide area.

46. The artificial implant according to claim 43, characterized in that, Along the circumferential direction of the stent, the first guiding structure is located in the middle of the plugging block, or is offset to one side.

47. The artificial implant according to claim 43, characterized in that, The first guiding structures on all the plugging blocks are offset in the same circumferential direction.

48. The artificial implant according to claim 1, characterized in that, The artificial implant further includes: An inner covering film, distributed around the inner peripheral wall of the stent. The plugging component is fixed to the outer side of the inner covering film. When the stent is in the released state, it protrudes outside the stent through the corresponding mesh.

49. The artificial implant according to claim 48, wherein, The stent comprises an inner frame defining a blood flow channel and an outer frame connected to the inner frame and located outside the inner frame in an expanded state. The inner coating is distributed around the inner peripheral wall of the inner frame.

50. The artificial implant according to claim 48, characterized in that, The artificial implant further comprises: when the stent is in a compressed state, the folded portion of the blocking component together with the inner covering film at the corresponding portion forms an inwardly bulging portion relative to the inner peripheral wall of the stent.

51. The artificial implant according to claim 50, wherein, From the perspective of the stent axial direction, at least 30% of the blocking component is located in the protrusion.

52. The artificial implant according to claim 48, characterized in that, The inner film is a PU film.

53. The artificial implant according to claim 48, characterized in that, The inner coating is bonded and fixed to the blocking component, or the blocking component is directly formed on the surface of the inner coating.

54. The artificial implant according to claim 48, characterized in that, The outflow side of the inner covering membrane is spliced ​​with the valve leaflet and fixed to the bracket.

55. The artificial implant according to claim 48, wherein, The inner covering film is provided with a second guiding structure.

56. The artificial implant according to claim 55, characterized in that, The blocking component has a first guiding structure, and when the stent is in a compressed state, the blocking component is folded at the first guiding structure; The second guiding structure and the first guiding structure correspond to each other in the circumferential direction of the bracket.

57. The artificial implant according to claim 1, characterized in that, The artificial implant also includes: The outer coating is distributed around the outer peripheral wall of the stent, and the blocking component is partially or completely wrapped by the outer coating.

58. The artificial implant according to claim 57, characterized in that, The artificial implant further comprises an inner covering film distributed around the inner peripheral wall of the stent, and the outer covering film and the inner covering film are an integral structure.

59. The artificial implant according to claim 58, characterized in that, The outer film and the inner film together form a pocket-shaped structure with a radial gap, the blocking component is fixed to the outer surface of the inner film, the blocking component is entirely in the pocket-shaped structure, or the outflow side of the blocking component is exposed outside the pocket-shaped structure.

60. The artificial implant according to claim 58, wherein, The inner coating has a second guiding structure, and the second guiding structure is connected to the outer coating.

61. The artificial implant according to claim 58, characterized in that, The outer film is provided with a third guiding structure.

62. The artificial implant according to claim 61, characterized in that, The third guiding structure and the inner covering film are connected to each other.

63. The artificial implant according to claim 61, wherein, The blocking component has a first guiding structure, and when the stent is in a compressed state, the blocking component is folded at the first guiding structure; The third guiding structure is embedded in the first guiding structure, and the embedded portion is fixedly connected to the blocking component and / or the inner covering membrane.

64. The artificial implant according to claim 61, characterized in that, The third guiding structure is fixedly connected to the blocking component and / or the inner covering film at least at an outflow side edge portion of the outer covering film.

65. The artificial implant according to claim 61, characterized in that, The width of the outer coating in the axial direction of the stent corresponds to at least one complete circle of grids, and the third guiding structure is located at the midline of the corresponding grid.

66. The artificial implant according to claim 61, characterized in that, The inner coating has a second guiding structure, and the outer coating has a third guiding structure. The second guiding structure and the third guiding structure are independently low-strength bands or predetermined folds.

67. The artificial implant according to claim 66, wherein, The low-strength belt is thinner than adjacent parts or is made of different materials.

68. The artificial implant according to claim 66, characterized in that, The predetermined fold is obtained by folding the fold back and forth and then performing heat treatment.

69. The artificial implant according to claim 66, wherein, The second guide structure and the third guide structure are respectively arranged at intervals along the circumferential direction of the bracket.

70. The artificial implant according to claim 66, wherein, The number of the second guiding structures and the third guiding structures is equal to or an integer multiple of the number of grids in the axial direction of the bracket.

71. The artificial implant according to claim 1, characterized in that, The support has a grid structure.

72. The artificial implant according to claim 1, characterized in that, The stent is released by self-expansion or by balloon expansion.

73. The artificial implant according to claim 1, characterized in that, The stent has an inlet side and an outlet side that are axially opposite in a blood flow environment. The interior of the stent is a blood flow channel. The artificial implant further includes valve leaflets connected to the stent and used to control the blood flow channel.

74. The artificial implant according to claim 73, characterized in that, The valve leaflets are 2, 3, or 4 pieces that cooperate with each other.

75. The artificial implant according to claim 73, wherein, The valve leaflets are made of biological materials or polymer materials.

76. The artificial implant according to claim 73, characterized in that, The blocking component is located on the inlet side of the valve leaflets.

77. The artificial implant according to claim 1, characterized in that, The stent includes an inner frame that defines the blood flow channel and an outer frame that is connected to the inner frame and is in the outer periphery of the inner frame in an expanded state. The outer frame is made of a memory material suitable for self-expanding release.

78. The artificial implant according to claim 77, wherein, The outer frame is an arm portion arranged at intervals in the circumferential direction and / or an outer frame sleeved on the outer periphery of the inner frame at intervals in the radial direction.

79. The artificial implant according to claim 5, wherein, The acting mode of the actuator on the blocking component is line contact to radially inwardly squeeze the blocking component.

80. The artificial implant according to claim 5, characterized in that, The actuator is a polymer wire, a metal wire, or a mixed wire of polymer and metal; The blocking component is a plurality of deformable blocking blocks, and the blocking blocks are arranged at intervals. The actuator squeezes a single blocking block or synchronously squeezes a plurality of blocking blocks.

81. The artificial implant according to claim 5, characterized in that, The stent is provided with a first connection point and a second connection point that are axially spaced. The actuator is a flexible member or a deformable structure. At least one end of the actuator is connected to the first connection point, and at least the other end is connected to the second connection point.

82. The artificial implant according to claim 5, characterized in that, The actuator at least includes a traction wire. Both ends of the traction wire are respectively restricted by two or more parts that are axially spaced on the stent. In the expanded state, the traction wire is slack to allow the blocking component to protrude outward. In the compressed state, the traction wire is taut to radially inwardly squeeze the blocking component.

83. The artificial implant according to claim 5, characterized in that, The actuator includes multiple traction wires and is arranged as follows: The multiple traction wires extend in the axial direction of the stent; and / or At least one of the traction wires extends in the circumferential direction of the stent; and / or At least one of the traction wires extends simultaneously in the axial and circumferential directions of the stent; and / or At least a part of one of the traction wires extends in the axial direction of the stent, and the other part extends in the circumferential direction of the stent.

84. The artificial implant according to claim 82, characterized in that, The end of the traction wire is connected to the stent and / or other traction wires by one or more of tying, threading, winding, bonding, and welding.

85. The artificial implant according to claim 84, characterized in that, In at least one grid, a traction wire extending in the axial direction of the stent intersects with a traction wire extending in the circumferential direction of the stent. The two traction wires are positioned or arranged movably at the intersection point.

86. The artificial implant according to claim 84, characterized in that, One of the traction wires is provided with a threading ring and is used for other traction wires to pass through the threading ring; The threading ring is formed by the traction wire itself winding; or The threading ring is independently arranged and connected to the corresponding traction wire.

87. The artificial implant according to claim 84, wherein In a single grid, the traction wire passes through the geometric center of the grid; There are multiple traction wires that intersect with each other, and the intersection position is close to the geometric center of the grid where they are located.

88. The artificial implant according to claim 84, characterized in that, Each grid provided with the blocking component corresponds to at least one traction wire. The number of traction wires in each grid provided with the blocking component is the same or different.

89. The artificial implant according to claim 84, wherein, The blocking component is a plurality of deformable blocking blocks, and the blocking blocks are arranged at intervals. All the blocking blocks are squeezed by one traction wire.

90. The artificial implant according to claim 84, characterized in that, The stent is partially hollowed out to form a grid structure, and the radial dimension of the traction wire is less than or close to the radial dimension of the ribs of the grid structure.

91. The artificial implant according to claim 5, characterized in that, The artificial implant further includes: An inner membrane, distributed around the inner peripheral wall of the stent, the occlusion member is fixed to the outer side of the inner membrane, and when the stent is in the released state, it protrudes out of the stent through the corresponding grid. An outer membrane, distributed around the outer peripheral wall of the stent, and at least a part or all of the occlusion member and / or the actuator is wrapped by the outer membrane.

92. An artificial implant, characterized in that, It includes: A stent, which is a tubular structure with a blood flow channel inside, and the tubular structure can be radially deformed and has corresponding compressed and expanded states along with the deformation. Valve leaflets, connected to the stent and used to control the blood flow channel. An occlusion member, connected to the stent and arranged circumferentially along the stent. When the stent is in the expanded state, at least a part of the occlusion member protrudes out of the outer periphery of the stent. Traction wires, connected to the stent. During the process of the stent changing from the expanded state to the compressed state, the traction wires act radially inward along the stent to at least a part of the occlusion member under the drive of the stent.

93. An artificial implant, characterized in that, It includes: A stent, which is a tubular structure, and the tubular structure can be radially deformed and has corresponding compressed and expanded states along with the deformation. An occlusion member, connected to the stent and arranged circumferentially along the stent. When the stent is in the expanded state, at least a part of the occlusion member protrudes out of the outer periphery of the stent. The occlusion member has a slit, and when the stent is in the compressed state, the occlusion member is guided to fold at the slit to adapt to the deformation of the stent.

94. An intervention system, characterized in that, It includes: An artificial implant, which is the artificial implant according to any one of claims 1 to 93 and is in the compressed state. A catheter assembly, at least one pipe fitting is passed through the inside of the artificial implant and connected to the artificial implant; at least one pipe fitting is wrapped around the outer periphery of the artificial implant. A control handle, connected to and driving the catheter assembly.

95. A method for driving the deformation of a blocking component on an artificial implant, characterized in that, It includes: Providing an artificial implant, the artificial implant at least includes a stent and an occlusion member, the occlusion member is connected to the stent and arranged circumferentially along the stent. When the stent is in the expanded state, at least a part of the occlusion member protrudes out of the outer periphery of the stent. The stent is threaded with traction wires. When the traction wires are slack, the occlusion member is allowed to protrude. When driving the occlusion member to deform, the traction wires are tightened, so that the traction wires act radially inward along the stent to at least a part of the occlusion member to drive the occlusion member to deform.

96. A method for driving the deformation of a sealing component on an artificial implant, characterized in that, It includes: Providing an artificial implant, the artificial implant at least includes a stent and an occlusion member, the occlusion member is connected to the stent and arranged circumferentially along the stent. When the stent is in the expanded state, at least a part of the occlusion member protrudes out of the outer periphery of the stent. The occlusion member has a slit. When driving the occlusion member to deform, the occlusion member is guided to fold at the slit by the deformation of the stent squeezing the occlusion member.

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