Prosthetic heart valve device

Abstract

The artificial heart valve device comprises a support and valve leaflets, the whole support is of a tubular structure and is provided with a hollow area, a blood flow channel is formed in the support, the number of the valve leaflets is multiple, and the valve leaflets are located in the blood flow channel and matched with one another so as to oppositely open or close the blood flow channel; the support is further provided with peripheral leakage preventing components, and the peripheral leakage preventing components are block-shaped distributed at intervals and correspond to the hollowed-out areas in position. The support has a compression state and an expansion state which are opposite to each other, in the expansion state, the peripheral leakage prevention components protrude out of the outer peripheral face of the support, in the same peripheral leakage prevention component, the thickness is gradually increased from the outflow side to the inflow side, the thickness is gradually reduced after the thickness reaches the highest protruding part, and the part with the largest protruding height is closer to the inflow side.

Description

[0001] This application is a divisional application of the application with the application date of "2022.06.24", the application number of "202410983335.3", and the invention name of "Artificial heart valve device, interventional instrument delivery assembly and control handle".

[0002] The patent application with the application number of "202410983335.3" is a divisional application of the international application number of PCT / CN2022 / 101336, the international application date of 2022.06.24, the entering national stage date of 2022.12.06, the national application number of 202280004892.5, and the invention name of "Artificial heart valve stent, device, delivery system and interventional system". TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and in particular to an artificial heart valve device. BACKGROUND

[0004] With the development of medical conditions, artificial heart valves have been used to treat heart valve disorders. Natural heart valves (such as aortic valve, pulmonary valve and mitral valve) provide important functions in ensuring adequate blood supply to the cardiovascular system. In some treatment cases, the natural heart valve may deteriorate due to congenital, inflammatory or infectious reasons, etc. Such damage to the natural heart valve can cause serious harm or even death.

[0005] In the related art, a common treatment for natural heart valve disease is to repair or replace the valve through surgical operation. In order to overcome the many complications that the above surgical operation can easily bring, in the related art, especially in the transvascular technique, a flexible catheter intervention and implantation of an artificial heart valve are adopted. The transvascular technique can achieve less invasion than surgical operation such as open-heart surgery. In the transvascular technique, the artificial valve in the loaded state is mounted on the distal end portion of the flexible catheter and is pushed through the blood vessels of the patient until the artificial valve reaches the implantation site. The artificial valve at the distal end of the catheter expands to its functional size at the site of the diseased natural valve.

[0006] The inventors have found that in the related art, during the implantation of a self-expanding artificial valve, when the operator starts to retract the delivery sheath in order to release the artificial valve, the artificial valve tends to "jump" out of the distal end of the sheath very quickly; in other words, the outward biasing force of the frame of the artificial valve tends to cause the artificial valve to pop out of the distal end of the delivery sheath very quickly, making it difficult to deliver the artificial valve from the sheath in a precise and controlled manner and increasing the risk of trauma to the patient.

[0007] Secondly, in the prior art valve products, the valve is usually recovered by pressing the valve stent through the forward sheath tube when the valve is expanded to 2 / 3; when the valve is fully expanded, it is difficult to recover the valve stent because the end of the valve stent has been fully expanded. SUMMARY

[0008] To solve the above technical problems, the application discloses an artificial heart valve stent, comprising:

[0009] a ring-shaped part, the ring-shaped part being a radially deformable structure, two ends of the ring-shaped part in the axial direction of the ring-shaped part being a first end and a second end respectively, wherein the edge of the first end comprises a plurality of unit segments arranged in sequence along the circumferential direction of the ring-shaped part;

[0010] a plurality of guide parts arranged in sequence and spaced apart along the circumferential direction of the ring-shaped part, one side of each guide part being connected to a corresponding unit segment, the other side of each guide part gradually converging to a terminal end, and the terminal end being provided with a threading ring.

[0011] Optionally, the artificial heart valve stent is based on radial deformation as a whole, has a relative compressed state and a released state, and in the released state, the length of the guide part is L1, the length of the ring-shaped part is L2, and L1:L2=1:0.5-1.5 in the axial direction of the ring-shaped part.

[0012] Optionally, L1:L2=1:0.6-1.2.

[0013] Optionally, along the axial direction of the ring-shaped part, one side of each guide part is a connecting side abutting against the corresponding unit segment, and the connecting sides of adjacent two guide parts abut against each other.

[0014] Optionally, in the released state, the convergence trend of the guide part from the connecting side to the terminal end is uniform convergence.

[0015] Optionally, along the circumferential direction of the ring-shaped part, the length of the connecting side is L3 and L1:L3=0.5-1.5.

[0016] Optionally, the number of guide parts is N, N is 2, 3, 4, 5 or 6, and the central angle of the connecting side of each guide part is 360 degrees / N.

[0017] Optionally, each guide part is arranged uniformly along the circumferential direction of the ring-shaped part.

[0018] Optionally, between adjacent two guide parts is an opening part, and in the compressed state, the adjacent two guide parts abut against each other to close the opening part.

[0019] Optionally, the guide portion and the ring portion each have a hollow cell structure, and the cells in the ring portion are arranged in multiple rows along the axial direction of the ring portion, and the junction between the guide portion and the ring portion is surrounded by the vertices of one row of cells in the circumferential direction.

[0020] Optionally, the guide portion extends from the ring portion along the axial direction of the ring portion, and the extending path first expands radially outward in the ring portion, and then gradually converges after reaching the maximum outer diameter.

[0021] Optionally, the axial length of the ring portion is 1-2.5 cells.

[0022] Optionally, the guide portion and the ring portion each have a hollow cell structure, and the cells in the guide portion are divided into opposite sparse and dense regions, and at least a part of the sparse regions is close to the opening between the two adjacent guide portions.

[0023] Optionally, the cell area of the dense region is 0.3-0.8 times the cell area of the sparse region (understood as the ratio of the area of a single cell, not the area of the entire sparse region and dense region).

[0024] Optionally, the cell area of the dense region is 0.4-0.6 times the cell area of the sparse region.

[0025] Optionally, in the guide portion, the edge frame strip adjacent to the opening is connected to the threading ring at one end and connected to the ring portion at the other end, and the intersection of the edge frame strip with other frame strips in the tubular structure is not more than two during extension.

[0026] Optionally, the edge frame strip is connected to a branch frame strip near the first end, and the branch frame strip and the edge frame strip are respectively connected to different cell vertices on the first end.

[0027] Optionally, the threading ring has a transition section shared with the surrounding cells on the side close to the ring portion, the transition section is V-shaped, and the vertex is directed towards the ring portion.

[0028] Optionally, the threading ring has a pulling section on the side away from the ring portion, and the threading ring has a transition section shared with the surrounding cells on the side close to the ring portion.

[0029] Optionally, the pulling section and the transition section enclose one or more closed spaces.

[0030] Optionally, the radius of the circumscribed circle of the threading ring is greater than or equal to twice the diameter of the rod of the threading ring.

[0031] Optionally, the guide portion includes four regions, respectively:

[0032] The first area is provided with the threading ring;

[0033] The second area is provided along the circumference of the annular part, and the first area and the second area are aligned and serve as a central area of the guide part;

[0034] The third area and the fourth area are provided along the circumference of the annular part on both sides of the central area.

[0035] Optionally, each of the second area, the third area and the fourth area is provided with only one cell, and one vertex of each cell is connected to the annular part.

[0036] Optionally, the guide part extends axially from the annular part, and the extending path first expands radially outward to a maximum outer diameter, and then gradually converges, and the maximum outer diameter is adjacent to the junction between the first area and the second area.

[0037] Optionally, a suture column is connected between the first area and the second area in the direction of the outflow end.

[0038] Optionally, the first area serves as the threading ring and includes a first cell, the second area is provided with a second cell, the outflow end of the second cell and the inflow end of the first cell share a node, and the second cell is fixedly combined with the valve.

[0039] Optionally, the third area and the fourth area are symmetrically arranged on both sides of the central area.

[0040] Optionally, the cell adjacent to the first area and the second area in the third area and the fourth area is a third cell, and among all the cells in the guide part, the third cell has the largest area.

[0041] Optionally, the area of the first area is larger than the area of the second cell.

[0042] Optionally, the artificial heart valve support is a tubular structure as a whole, and the tubular structure has a waist portion with a reduced diameter in the axial middle area.

[0043] Optionally, the junction between the guide part and the annular part is located at the waist portion.

[0044] Optionally, the junction between the guide part and the annular part is adjacent to the minimum outer diameter of the waist portion.

[0045] Optionally, the opening part is located between two adjacent guide parts, and the opening part expands radially outward in a direction away from the annular part to form a V-shaped structure.

[0046] Optionally, the axis of the annular portion where all the leaflets meet when closed is adjacent to the waist portion.

[0047] Optionally, the annular portion comprises a plurality of rows of cells, and the size of the cells decreases along the direction of the guide portion.

[0048] Optionally, in a row of cells at the second end of the annular portion, each cell is quadrilateral, and the two sides closer to the second end are longer than the two sides closer to the first end.

[0049] Optionally, the annular portion comprises a plurality of rows of cells, and the size of the cells decreases along the direction of the guide portion.

[0050] Optionally, the edge of the leaflet comprises a fixed edge fixed to the artificial heart valve support and a free edge cooperating with other leaflets to control the blood flow passage, and according to the direction of the leaflet controlling the blood flow, the first end is the outflow side and the second end is the inflow side, wherein the two ends of the fixed edge are fixed on the two adjacent guide portions respectively, and the middle part of the fixed edge extends to the annular portion.

[0051] Optionally, along the axial direction of the annular portion, the junction between the guide portion and the annular portion is adjacent to the position of the free edge of the leaflet.

[0052] Optionally, adjacent leaflets are connected to each other through a joint portion and fixed to the support, and each joint portion is located in a corresponding guide portion.

[0053] Optionally, along the circumferential direction of the annular portion, each guide portion has a symmetry axis of its own structure, and the fixed edges of the two connected leaflets meet at the symmetry axis of the corresponding guide portion.

[0054] Optionally, the midpoint of the fixed edge is adjacent to the axial middle part of the annular portion.

[0055] Optionally, the inside of the artificial heart valve support is provided with an inner covering film, and the inner covering film is located on the inflow side of the leaflet and is in butt joint with the fixed edge of each leaflet.

[0056] Optionally, the inner covering film extends from the fixed edge of the leaflet to the second end of the annular portion.

[0057] Optionally, the artificial heart valve support is further provided with a peripheral leakage prevention component on the inflow side of the leaflet.

[0058] Optionally, the peripheral leakage prevention component is fixed on the outside of the inner covering film, and the peripheral leakage prevention component is in the form of blocks distributed at intervals and the position corresponds to the hollow area of the tubular structure.

[0059] Optionally, the anti-circumferential leakage component is in an integral structure with the inner covering film, and in the expanded state, the anti-circumferential leakage component protrudes outward from the outer circumferential surface of the stent.

[0060] Optionally, the inner covering film is made of PET material, and the anti-circumferential leakage component is made of PU material.

[0061] Optionally, the tubular structure has a plurality of unit cell structures arranged in a ring, and in the same anti-circumferential leakage component, the highest protruding part is closer to the inflow side of the unit cell.

[0062] Optionally, in the same anti-circumferential leakage component, the distance between the highest protruding part and the inflow side of the unit cell is S1, and the distance between the highest protruding part and the outflow side of the unit cell is S2, wherein S1:S2 is 0-0.8 (preferably 0.3-0.8).

[0063] Optionally, in the same anti-circumferential leakage component, the thickness gradually increases from the outflow side to the inflow side, and then gradually decreases after the highest protruding part.

[0064] The application also discloses a delivery assembly of an interventional instrument, which comprises:

[0065] an inner sheath tube having opposite distal and proximal ends;

[0066] a lock seat connected to the distal end of the inner sheath tube;

[0067] an inner core slidingly arranged in the inner sheath tube, one end of the inner core being an extension segment extending out of the distal end of the inner sheath tube, and the radial gap between the inner core and the inner sheath tube being a through channel;

[0068] a lock piece fixed to the extension segment of the inner core and located on the distal end side of the lock seat;

[0069] a pull wire assembly having a working end at the distal end, the pull wire assembly being movably arranged in the through channel;

[0070] in the loaded state of the interventional instrument, the working end of the pull wire assembly extends out of the distal end of the inner sheath tube, passes around the interventional instrument (the interventional instrument can be the artificial heart valve stent mentioned above, and the pull wire cooperates with the threading ring therein) and is bound to the lock piece, and the lock piece and the lock seat are in plug-in cooperation to limit the pull wire from being unbound.

[0071] Optionally, the lock seat is provided with a locking part cooperating with the lock piece, and in the locked state, the lock piece is inserted into the locking part and restricts the movement range of the pull wire.

[0072] Optionally, the locking part is a lock hole or a lock groove.

[0073] Optionally, the lock piece moves with the inner core and has the following positions:

[0074] a release position, in which the lock piece is disengaged from the lock hole to release the working end of the pull wire;

[0075] a locking position, in which the lock piece is inserted into the lock hole to constrain the working end of the pull wire.

[0076] Optionally, the extension section of the inner core is provided with a mounting seat, the lock piece is fixed to the mounting seat and extends in the proximal direction from the mounting seat. The mounting seat is provided with a mounting hole for mounting the lock piece, the distal end of the lock piece is fixedly inserted into the mounting hole, and the proximal end of the lock piece extends out of the mounting hole.

[0077] Optionally, a plurality of lock pieces are arranged at intervals in the circumferential direction of the inner core, and the lock holes are arranged correspondingly to the lock pieces.

[0078] Optionally, at least three lock pieces are uniformly arranged in the circumferential direction of the inner core.

[0079] Optionally, the lock piece is rod-shaped.

[0080] Optionally, the strokes of the at least two lock pieces from the release position to the locking position are different.

[0081] Optionally, the lengths of the at least two lock pieces are different.

[0082] Optionally, the lengths of any two lock pieces are different.

[0083] Optionally, the pull wire assembly is one or more pull wires extending from a handle of a delivery system.

[0084] Optionally, the pull wire assembly comprises a wire control tube and a pull wire, the wire control tube movably sheaths the outside of the inner core, one end of the pull wire is a driving end and is connected to the wire control tube, the other end of the pull wire is a working end, and in a loaded state of the interventional instrument, the working end is routed to the interventional instrument and cooperates with the lock piece.

[0085] Optionally, the proximal end of the wire control tube is movably arranged relative to the control handle.

[0086] Optionally, the wire control tube movably sheaths between the inner core and the inner sheath.

[0087] Optionally, the lock seat is further provided with a guide hole, and the pull wire extends outward from the guide hole.

[0088] Optionally, the lock seat comprises a guide disc, a connecting sleeve and a fixing disc connected in sequence from the distal end to the proximal end, wherein the lock hole is formed in the fixing disc, and the guide disc is provided with a guide hole corresponding to the position of the lock hole.

[0089] The lock member penetrates the guide hole in the locking position, inserts into the lock hole, and the working section of the lock member is located between the guide disc and the fixed disc, and the working end of the pull wire is constrained by the working section.

[0090] Optionally, the fixed disc is provided with a guide hole for the pull wire to pass through, and the pull wire extends to the distal side of the fixed disc through the guide hole and cooperates with the lock member.

[0091] Optionally, the part of the pull wire extending to the distal side of the fixed disc is a controllable section for controlling the release degree of the interventional instrument, and the length of the controllable section is adjusted through the position of the wire control tube when the working end of the pull wire is constrained by the lock member.

[0092] Optionally, the guide hole and the lock hole are respectively provided with a plurality of holes, and the holes are alternately arranged in the circumferential direction of the fixed disc.

[0093] Optionally, the pull wire is wound around the interventional instrument in the following way:

[0094] The working end of the pull wire cooperates with the lock member through the structure of the interventional instrument itself; or

[0095] The interventional instrument is provided with a connecting piece, and the working end of the pull wire passes through the connecting piece and cooperates with the lock member.

[0096] Optionally, a gap or an additional through hole is provided in the structure of the interventional instrument.

[0097] Optionally, a plurality of connecting ears are provided on the interventional instrument, and the through holes are provided in the connecting ears.

[0098] Optionally, the connecting piece is a flexible wire ring, and the wire ring passes through the through holes of the connecting ears in sequence.

[0099] Optionally, the working end of the pull wire is provided with a cooperating ring, and the lock member penetrates the cooperating ring to constrain the pull wire.

[0100] Optionally, the lock member is a rod-shaped member extending in the axial direction of the pipe, and the lock member penetrates the inside of the pull wire wound around to constrain the pull wire in the locking position.

[0101] Optionally, the closed space is provided by the cooperating ring.

[0102] Optionally, the cooperating ring is an independent component; or is formed by winding the pull wire itself.

[0103] Optionally, the cooperating ring is arranged in at least one of the following ways:

[0104] The pull wire is a single wire structure between the driving end and the working end, and the single wire is wound around the working end to form the matching ring;

[0105] Or the pull wire is a double wire structure, and the double wire is folded back at the working end to form the matching ring.

[0106] Or the pull wire itself is a multi-strand woven structure, and the gap part of the woven structure is used as the matching ring.

[0107] Optionally, the interventional instrument delivery assembly further comprises a wire control tube, the wire control tube is sleeved outside the inner core, one end of the pull wire is a driving end, the driving end extends to the proximal end in the wire control tube and is controlled by the control handle, the other end of the pull wire is a working end, and the working end is matched with the locking piece after winding through the interventional instrument in the loaded state.

[0108] Optionally, the proximal end of the wire control tube is fixedly arranged relative to the control handle.

[0109] Optionally, the wire control tube has a plurality of cavities in the wall, and each pull wire is movably arranged in the corresponding cavity.

[0110] Optionally, the interventional instrument delivery assembly further comprises a bending adjusting member, the bending adjusting member is arranged inside or outside the inner sheath tube, the bending adjusting member and the distal end parts of the inner sheath tube and the inner core are fixedly arranged, and the proximal ends are slidingly matched to realize the bending adjustment of the inner sheath tube on the distal end side.

[0111] Optionally, the bending adjusting member is at least one of a pipe member, a rod member and a pull wire; and the bending adjusting member is arranged inside or outside the inner sheath tube.

[0112] Optionally, the interventional instrument delivery assembly further comprises an outer sheath tube, the outer sheath tube is slidingly sleeved outside the bending adjusting member, the outer sheath tube moves relative to the interventional instrument to accommodate or release the interventional instrument, and the pull wire controls the release of the interventional instrument under the constraint of the wire control tube.

[0113] Optionally, the interventional instrument delivery assembly further comprises a sheath tube, the sheath tube is sleeved outside the outer sheath tube, and the sheath tube is used to establish an interventional channel.

[0114] The application further discloses an interventional instrument delivery system, which comprises the delivery assembly in the technical solution and a control handle used for driving the delivery assembly, and the inner sheath tube, the inner core and the pull wire of the delivery assembly extend to the control handle and move relatively under the driving of the control handle.

[0115] Optionally, the control handle has opposite distal and proximal ends for driving the inner sheath, the inner core and the pull wire to move relative to each other, the control handle comprises a support body and a plurality of sets of connecting assemblies mounted on the support body, each set of connecting assemblies is divided into fixed and movable settings relative to the support body, the movable set of connecting assemblies comprises screw transmission, gear and rack transmission and direct transmission according to the transmission mode, and the connecting assemblies of each transmission mode are sequentially arranged from the distal end to the proximal end.

[0116] The application also discloses an interventional system, comprising an artificial heart valve and a delivery assembly, the artificial heart valve comprises a stent and valve leaves in the stent, the stent is a tubular structure as a whole and has a blood flow passage inside, and the valve leaves are a plurality of pieces and cooperate with each other in the blood flow passage to relatively open or close the blood flow passage.

[0117] The stent comprises:

[0118] The annular part is a radially deformable structure, and two ends of the annular part in the axial direction are a first end and a second end respectively, wherein the edge of the first end comprises a plurality of unit segments arranged in sequence in the circumferential direction of the annular part.

[0119] A plurality of guide parts are arranged in sequence and at intervals in the circumferential direction of the annular part, one side of each guide part is connected to a corresponding unit segment, the other side of each guide part gradually converges to a terminal end, and the terminal end is provided with a threading ring, the guide part comprises four regions, namely:

[0120] The first region is provided with the threading ring;

[0121] The second region is arranged in the circumferential direction of the annular part, the second region is aligned with the first region and serves as a central region of the guide part;

[0122] The third region and the fourth region are arranged on both sides of the central region in the circumferential direction of the annular part;

[0123] The adjacent valve leaves are connected to each other through joint parts and fixed to the stent, the position of each joint part is in a corresponding guide part, each guide part has a symmetry axis of its own structure in the circumferential direction of the annular part, and the fixed edges of the connected two valve leaves intersect at the symmetry axis of the corresponding guide part;

[0124] The delivery assembly comprises:

[0125] The inner sheath has opposite distal and proximal ends;

[0126] The lock seat is connected to the distal end of the inner sheath;

[0127] The inner core is slidably arranged in the inner sheath tube, one end of the inner core is an extension section extending out of the distal end of the inner sheath tube, and the radial gap of the inner core and the inner sheath tube is a threading channel;

[0128] The lock piece is fixed to the extension section of the inner core and is located on the distal end side of the lock seat, and the lock piece is uniformly provided with at least three lock pieces in the circumferential direction of the inner core, and the lengths of at least two lock pieces are different;

[0129] The pull wire assembly has a working end at the distal end, the pull wire assembly is movably arranged in the threading channel, the working end of the pull wire extends out of the distal end of the inner sheath tube, passes through the threading ring and is bound to the lock piece, and the lock piece and the lock seat are inserted and matched to limit the pull wire assembly from being unbound.

[0130] The technical scheme disclosed in the application realizes the whole-process control of the artificial heart valve stent through the guide part, especially the threading ring, and the setting mode and the extension shape of the guide part can reduce the influence of the self-expanding characteristics of the artificial heart valve stent on the recovery thereof. The operation experience of medical staff is improved, and the treatment effect is improved.

[0131] The pull wire of the delivery assembly can realize the phased release of the interventional instrument, and the mutual movement of the tubes can provide a structural basis for the full release and full recovery of the interventional instrument, so as to provide a more controllable interventional treatment process, improve the treatment effect and improve the patient experience.

[0132] Specific beneficial technical effects will be further explained in the specific embodiments in combination with specific structures or steps. BRIEF DESCRIPTION OF DRAWINGS

[0133] Figure 1 A schematic diagram of a resistance point of a stent in the prior art in the recovery process;

[0134] Figure 2a A schematic diagram of an artificial heart valve stent in an embodiment;

[0135] Figure 2b A schematic diagram of an artificial heart valve stent in an embodiment; Figure 2a A schematic diagram of an artificial heart valve stent in an embodiment from a top view;

[0136] Figure 2c A schematic diagram of an artificial heart valve stent in an embodiment from a top view; Figure 2a A schematic diagram of the axial length proportion relationship of each part of an artificial heart valve stent in an embodiment;

[0137] Figure 2d A schematic diagram of the axial length proportion relationship of each part of an artificial heart valve stent in an embodiment; Figure 2e A schematic diagram of an artificial heart valve stent in an embodiment from different views; Figure 2a A schematic diagram of an artificial heart valve stent in an embodiment from different views;

[0138] Figure 2f A schematic diagram of an artificial heart valve stent in an embodiment from different views; Figure 2aEnlarged schematic diagram of the guide section of an artificial heart valve stent;

[0139] Figure 2g for Figure 2a Enlarged schematic diagram of the threading loop of the artificial heart valve stent;

[0140] Figure 2h A three-dimensional view of an artificial heart valve stent in another embodiment;

[0141] Figure 2i for Figure 2h Front view of an artificial heart valve stent;

[0142] Figure 2j for Figure 2h Enlarged schematic diagram of the central guide section;

[0143] Figure 2k A three-dimensional view of an artificial heart valve stent in another embodiment;

[0144] Figure 2l for Figure 2k Front view of an artificial heart valve stent;

[0145] Figure 2m for Figure 2k Enlarged schematic diagram of the central guide section;

[0146] Figure 3a This is a schematic diagram of an artificial heart valve stent in one embodiment;

[0147] Figure 3b , Figure 3c as well as Figure 3d for Figure 3a Schematic diagrams of artificial heart valve stents from different perspectives;

[0148] Figure 3e for Figure 3a Enlarged diagram showing the position of the circle in the image;

[0149] Figure 3f for Figure 3a A top-view 3D schematic diagram of an artificial heart valve stent;

[0150] Figure 4a This is a schematic diagram of an artificial heart valve device in one embodiment;

[0151] Figure 4b , Figure 4c as well as Figure 4d for Figure 4a Schematic diagrams of an artificial heart valve device from different perspectives;

[0152] Figure 4e for Figure 4d Enlarged schematic diagram of a Chinese artificial heart valve device;

[0153] Figure 4f This is a schematic diagram showing the arrangement of the anti-leakage components according to another embodiment;

[0154] Figure 4g This is a schematic diagram showing the arrangement of the anti-leakage components according to another embodiment;

[0155] Figure 4h This is a schematic diagram showing the arrangement of the anti-leakage components according to another embodiment;

[0156] Figure 4i This is a schematic diagram of the joint portion of an artificial heart valve device in one embodiment;

[0157] Figure 4j for Figure 4i A three-dimensional view;

[0158] Figure 5a This is a schematic diagram of the distal side of the conveying component in one embodiment of this application;

[0159] Figure 5b for Figure 5a Enlarged schematic diagram of the conveyor components in the diagram;

[0160] Figure 5c for Figure 5a Another magnified view of the conveyor components in the diagram;

[0161] Figure 5d for Figure 5a Enlarged schematic diagram of the lock seat and pull line in the conveying assembly;

[0162] Figure 5e for Figure 5a Enlarged schematic diagram of the lock seat in the conveying assembly;

[0163] Figure 5f for Figure 5a A schematic diagram illustrating the differences in the locking components within the conveyor assembly;

[0164] Figure 5g This is a schematic diagram of the connection between the traction wire and the interventional instrument via a connector in one embodiment;

[0165] Figure 6a This is a schematic diagram of a control handle in one embodiment;

[0166] Figure 6b for Figure 6a A schematic diagram of the internal assembly of the control handle in the diagram;

[0167] Figure 6c for Figure 6a A schematic diagram of the internal structure of the control handle in the diagram;

[0168] Figure 6d forFigure 6a A schematic diagram of the internal structure of the control handle from another perspective;

[0169] Figure 6e This is a schematic diagram of the exhaust assembly structure in one embodiment;

[0170] Figure 7a This is a schematic diagram of the control handle in another embodiment;

[0171] Figure 7b for Figure 7a A schematic diagram of the internal assembly of the control handle in the diagram;

[0172] Figure 7c for Figure 7a A schematic diagram of the internal structure of the control handle in the diagram;

[0173] Figure 7d This is a schematic diagram of the gear connection assembly structure in one embodiment;

[0174] Figure 7e for Figure 7d Another perspective structural diagram of the gear connection assembly;

[0175] Figure 7f for Figure 7d A schematic diagram of the internal structure of the gear connection assembly in the diagram;

[0176] Figure 7g This is a schematic diagram of the assembly of various pipe fittings in one embodiment;

[0177] Figure 7h A perspective view of the control handle in another implementation;

[0178] Figure 7i for Figure 7h Exploded view of the control handle;

[0179] Figure 7j for Figure 7h A cross-sectional view of the control handle;

[0180] Figure 7k for Figure 7i A partial structural diagram of the control handle at the gear and rack;

[0181] Figure 7l for Figure 7k Exploded view;

[0182] Figure 7m for Figure 7k A schematic diagram of the structure between the gear, rack, and clamping base;

[0183] Figure 7n for Figure 7h The main view of the control handle;

[0184] Figure 7o Fig. 1 is a perspective view of a delivery assembly according to an embodiment of the present application; Figure 7n Fig. 2 is a sectional view of the middle A-A part of Fig. 1;

[0185] Figure 8a Fig. 3 is a schematic view of a distal side of the delivery assembly of Fig. 1 adjusting a bending angle;

[0186] Figure 8b Fig. 4 is a schematic view of the delivery assembly of Fig. 1 delivering an interventional instrument to a target point;

[0187] Figure 8c Fig. 5 is a schematic view of the delivery assembly of Fig. 1 adjusting a position of the interventional instrument relative to the target point;

[0188] Figure 9a Fig. 6 is a schematic view of the delivery assembly of Fig. 1 semi-releasing the interventional instrument;

[0189] Figure 9b Fig. 7 is a schematic view of the delivery assembly of Fig. 1 fully releasing the interventional instrument and in a state of preventing loosening of a pull wire;

[0190] Figure 9c Fig. 8 is a schematic view of the delivery assembly of Fig. 1 fully releasing the interventional instrument and in a state of releasing the pull wire.

[0191] Reference signs in the drawings are explained as follows:

[0192] 10, inner core; 11, extension section; 12, threading passage; 13, locking piece; 131, mounting seat; 132, mounting hole;

[0193] 20, wire control tube; 21, pull wire; 211, driving end; 212, working end; 22, matching ring;

[0194] 30, inner sheath tube; 31, locking seat; 311, locking hole; 312, guide hole; 313, guide disc; 314, connecting sleeve; 315, fixed disc; 316, guide hole;

[0195] 40, bending adjusting piece;

[0196] 50, outer sheath tube; 51, sheath tube;

[0197] 60, control handle; 61, support body; 611, fixed seat; 612, sliding seat; 62, screw thread matching area; 621, screw thread connecting assembly; 622, driving ring; 623, positioning ring; 624, positioning tooth; 625, clamping piece; 63, gear rack matching area; 631, gear connecting assembly; 632, base; 6321, sliding rail; 6322, elastic buckle; 6323, first limiting boss; 6324, second limiting boss; 633, clamping base; 634, rack; 6341, first limiting boss; 6342, second limiting boss;

[0198] 635, gear; 6351, rotating shaft; 636, driving part; 637, connecting and locking mechanism; 6371, first locking tooth; 6372, second locking tooth; 6373, retaining assembly; 6374, clamping column; 6376, reset member; 6377, locking pin; 6378, insertion hole; 638, supporting cylinder; 6381, clamping block; 6382, outer protrusion; 6383, limiting seat; 64, exhaust assembly; 641, liquid injection hole; 65, positioning mechanism;

[0199] 70, artificial heart valve support; 701, waist; 702, resistance point;

[0200] 71, annular part; 71a, annular part; 71b, annular part; 711, first end; 712, second end; 713, unit segment;

[0201] 72, guide part; 72a, guide part; 72b, guide part; 721, terminal end; 722, threading ring; 7221, pulling segment; 7222, transition segment; 723, connecting side; 724, opening site; 725, sparse area; 726, dense area; 727, closed area; 7271, first area; 7272, second area; 7273, third area; 7274, fourth area; 7275, central area; 7281, maximum outer diameter; 7282, edge frame strip; 7283, branch frame strip; 7284, symmetry axis;

[0202] 73, valve leaflet; 731, fixed rim; 732, free rim; 733, outflow side; 734, inflow side; 735, joint part; 7352, lug;

[0203] 74, inner covering membrane; 741, peripheral leakage prevention component; 7411, first circle of peripheral leakage prevention components; 7412, second circle of peripheral leakage prevention components; 7413, third circle of peripheral leakage prevention components; 7414, outer protrusion site;

[0204] 75, blood flow channel;

[0205] 81, threading ring; 82, second area; 82a, second unit cell; 82b, unit cell; 82c, unit cell; 83, third area; 84, fourth area; 84a, third unit cell; 84b, unit cell; 84c, unit cell;

[0206] 90, interventional instrument; 91, connecting piece; 92, connecting lug. DETAILED DESCRIPTION

[0207] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0208] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.

[0209] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0210] Reference Appendix Figure 1 As shown, when the stent is not accurately positioned during surgery and needs to be retrieved from the sheath, the stent's self-expansion characteristic can easily create a resistance point 702 that interferes with the delivery assembly, thus interfering with the stent retrieval process.

[0211] like Figure 2a As shown in 3a and 4a, this application discloses an artificial heart valve device, including an artificial heart valve stent and multiple leaflets and a covering inside the stent. The artificial heart valve stent is a tubular structure with a compressed state and an expanded state. The interior of the stent is a blood flow channel, and each leaflet is located in the blood flow channel and cooperates with each other to relatively open or close the blood flow channel.

[0212] Reference Appendix Figure 2a To be continued Figure 2g An artificial heart valve stent 70 is disclosed, comprising:

[0213] The annular portion 71 is located at the inflow end of the support, and can also be referred to as the inflow end region. The annular portion 71 is a radially deformable structure composed of several compressible cell units. The two ends of the annular portion 71 in its own axial direction are the first end 711 and the second end 712, respectively. The edge of the first end 711 includes multiple unit segments 713 arranged sequentially along the circumference of the annular portion 71. The axial length of the annular portion 71 is the length of 1.5 cell units.

[0214] Multiple guide sections 72 are located at the outflow end of the support, also known as the outflow end region; they are arranged sequentially at intervals along the circumference of the annular section 71. One side of each guide section 72 is connected to a corresponding unit segment 713, and the other side of each guide section 72 gradually converges to the end 721, and has a threading ring 722 at the end 721.

[0215] This application achieves fully controllable release of the artificial heart valve stent 70 through the guide section 72, especially the threading ring 722, including the retrieval of the valve stent that has completely detached from the sheath, thereby improving the accuracy of surgical implantation. At the same time, the arrangement and extension shape of the guide section 72 can reduce the impact of the self-expansion characteristics of the artificial heart valve stent 70 on its retrieval.

[0216] Regarding the overall proportions of the guide section 72, refer to the appendix. Figures 2b-2c In the illustrated embodiment, the artificial heart valve stent 70 is based on radial deformation and has relative compressed and released states. In the released state, with the axial direction of the annular portion 71 as the length direction, the length of the guide portion 72 is L1, and the length of the annular portion 71 is L2, satisfying L1:L2 = 1:0.5 to 1.5. In a specific product, L1:L2 = 1:0.6 to 1.2.

[0217] Regarding the connection configuration of the guide section 72, please refer to the appendix. Figure 2f In the illustrated embodiment, along the axial direction of the annular portion 71, one side of each guide portion 72 is a connecting side 723 that abuts against the corresponding unit segment 713, and the connecting sides 723 of adjacent guide portions 72 are connected to each other. In an extended embodiment, the connecting sides 723 of adjacent guide portions 72 may also be spaced apart. Regardless of how adjacent guide portions 72 are arranged, from the overall arrangement of each guide portion 72, each guide portion 72 is evenly arranged along the circumference of the annular portion 71, for example, as... Figure 2b As shown, along the circumference of the annular portion 71, the length of the connecting side 723 is L3, satisfying L1:L3 = 0.5~1.5. The length L3 of the connecting side 723 should be understood as the arc length on the circumferential surface of the annular portion 71. (The attached text is incomplete and requires further context.) Figure 3a To be continued Figure 3f and appendix Figure 4a To be continued Figure 4e The artificial heart valve stent 70 is similar and will not be described again here. Regarding the selection of the number of guide sections 72, referring to one embodiment, the guide sections 72 are N, where N is 2, 3, 4, 5 or 6, and the central angle corresponding to the connecting side 723 of each guide section 72 is 360 degrees / N.

[0218] Regarding the extension trend of the 72-point guide section, refer to the appendix. Figure 2a and attached Figure 3bIn the embodiment shown, in the released state, the guiding portion 72 has a uniform convergence trend from the connecting side 723 to the end 721. For reference, see the cross-sectional view of the artificial heart valve stent 70 shown in FIG. 2B. Figure 4a In the embodiment shown, in the released state, the guiding portion 72 has a convergence trend that is small first and then large and finally small from the connecting side 723 to the end 721. When considering the convergence trend, the projection shape of the guiding portion 72 in the radial direction of the annular portion 71 should be considered, and the uniform convergence mentioned in this embodiment should be understood as the overall trend, and it does not exclude that the edge of the guiding portion 72 is provided with protrusions or recesses at individual positions. When viewed in other directions, the extension trend of the guiding portion 72 can be provided separately, for reference, see the cross-sectional view of the artificial heart valve stent 70 shown in FIG. 2C. Figure 2d , FIG. 2C Figure 3c and FIG. 2D Figure 4b In the embodiment shown, the guiding portion 72 extends from the annular portion 71 in the axial direction of the annular portion 71, and the path of the extension first expands outward in the radial direction of the annular portion 71, and then gradually converges after reaching the maximum outer diameter 7281.

[0219] As can be easily understood from the foregoing, there will be a certain gap between the ends 721 of the guiding portions 72, and the opening portion 724 is between the adjacent two guiding portions 72. In the compressed state, the adjacent two guiding portions 72 abut and close the opening portion 724. In the process of state switching of the artificial heart valve stent 70, the size of the opening portion 724 also changes synchronously.

[0220] In specific implementation forms, the guiding portion 72 and the annular portion 71 both have a hollow cell structure, and along the axial direction of the annular portion 71, the cells in the annular portion 71 are multiple circles, and the junction between the guiding portion 72 and the annular portion 71 is surrounded by the vertices of one of the circles of cells.

[0221] The guiding portion 72 and the annular portion 71 with the cell structure can better adapt to the state switching of the artificial heart valve stent 70, and at the same time, the mechanical properties of the artificial heart valve stent 70 can be finely adjusted through the setting of the cell structure. The axial length of the annular portion 71 is 1-2.5 cells. As shown in FIG. 2A, Figure 2i As shown in FIG. 2B, the axial length of the annular portion 71 spans 2 cells, and as shown in FIG. 2C, Figure 2l As shown in FIG. 2D, the axial length of the annular portion 71 spans 2.5 cells, and the specific structure of the cell can be a polygon; for example, the diamond-shaped cell shown in the drawings.

[0222] As shown in FIG. 2A, the axial length of the annular portion 71 spans 1 cell, and as shown in FIG. 2B, Figures 2a-2dThe guide part 72 and the annular part 71 both have a hollow cell structure, the cells in the guide part 72 are divided into opposite sparse areas 725 and dense areas 726, and at least part of the sparse areas 725 are close to the opening part between the two adjacent guide parts 72. The sparse areas and the dense areas in the present application are relative, the sparse area refers to the cell having a larger area, and the dense area refers to the cell having a relatively smaller area, that is, the cell area of the sparse area is larger than that of the dense area. For example, the cell area corresponding to the sparse area 725 is larger than that of the dense area 726. The cells with different sparse degrees can finely adjust the mechanical properties of each part of the guide part 72, thereby improving the compliance of the guide part 72 and providing a smoother operation experience in the release and recovery process.

[0223] In the specific layout, refer to the embodiments shown in the drawings of Figure 2f , the drawings of Figure 3a and the drawings of Figure 4c , the guide part 72 includes four closed areas 727, which are respectively:

[0224] The first area 7271 is located at the nearest end of the stent and is used for connecting the delivery system. In the present application, the first area is a threading ring 722, which includes a first cell.

[0225] The second area 7272 is a dense area 726, which is arranged along the circumference of the annular part 71. The second area 7272 is opposite to the first area 7271 and serves as the center area 7275 of the guide part 72. The second area is used for fixing the ear 7352 of the valve and includes at least one second cell. In the present embodiment, the second area includes only one cell, that is, the second cell. In other embodiments, the second area can include multiple cells. The outflow end node A of the second cell is connected to the inflow end node B of the first cell through a suture column AB, and a suture hole is arranged on the suture column AB. The first connecting strip is parallel to the longitudinal axis of the stent.

[0226] The third area 7273 is a sparse area 725, which is arranged along the circumference of the annular part 71 and is located on one side of the center area 7275. In the present embodiment, the third area includes only one third cell, and in other embodiments, the third area can include multiple cells.

[0227] The fourth area 7274 is a sparse area 725, which is arranged along the circumference of the annular part 71 and is located on the other side of the center area 7275. In the present embodiment, the fourth area includes only one fourth cell, and in other embodiments, the fourth area can include multiple cells.

[0228] In the embodiment, in the first, second, third, and fourth cells, the third and fourth cells have the same size and the largest area, the first cell has the smallest area, and the second cell has an area between that of the third cell and the first cell.

[0229] In an implementation, the dense area 726 of the second area 7272 can be realized by increasing the number of cells in the same area, or by reducing the corresponding area under the premise of the same number of cells. In principle, it is realized that more ribs are arranged in the unit area in the dense area 726. In an embodiment, the cell area of the dense area 726 is 0.3-0.8 times the cell area of the sparse area 725. In a specific product, the cell area of the dense area 726 is 0.4-0.6 times the cell area of the sparse area 725.

[0230] Referring to FIG. 7, the first area 7271, the second area 7272, the third area 7273, and the fourth area 7274 are arranged in the ring-shaped part 71 in sequence along the circumferential direction of the ring-shaped part 71. Figure 2f In the embodiment shown in the drawings, the second area 7272, the third area 7273, and the fourth area 7274 each have only one cell, and one vertex of each cell is connected to the ring-shaped part 71. In the drawings, the cell shape of the third area 7273 and the fourth area 7274 is the same or similar, and the cell shape of the third area 7273 and the fourth area 7274 is different from the cell shape of the second area 7272 to form a change in density.

[0231] Referring to FIG. 7, the first area 7271, the second area 7272, the third area 7273, and the fourth area 7274 are arranged in the ring-shaped part 71 in sequence along the circumferential direction of the ring-shaped part 71. Figure 2f In the embodiment shown in the drawings, the guide part 72 extends from the ring-shaped part 71 in the axial direction of the ring-shaped part 71, and the path of the extension first expands radially outward, and then gradually converges after reaching the maximum outer diameter 7281, which is adjacent to the junction between the first area 7271 and the second area 7272. Referring to FIG. 7, the guide part 72 extends from the ring-shaped part 71 in the axial direction of the ring-shaped part 71, and the path of the extension first expands radially outward, and then gradually converges after reaching the maximum outer diameter 7281, which is adjacent to the junction between the first area 7271 and the second area 7272. Figure 2f In the embodiment shown in the drawings, the edge frame 7282 is adjacent to the opening part in the guide part 72, one end of the edge frame 7282 is connected to the threading ring, the other end of the edge frame 7282 is connected to the ring-shaped part 71, and the edge frame 7282 has no more than two intersection points with other frames in the tubular structure during the extension. In the drawings, the intersection point is one. The edge frame 7282 is connected to a branch frame 7283 near the first end 711, and the branch frame 7283 and the edge frame 7282 are respectively connected to different cell vertices on the first end 711.

[0232] The whole process control of the artificial heart valve support 70 needs the cooperation of the threading ring 722. Referring to FIG. 7, the threading ring 722 is connected to the edge frame 7282 of the guide part 72, and the threading ring 722 is connected to the first end 711 of the ring-shaped part 71. Figure 2g In the embodiment shown in the drawings, the threading ring 722 is a pulling section 7221 away from the ring-shaped part 71, and the pulling section 7221 is arc-shaped. The threading ring 722 is a transition section 7222 shared with the surrounding cells near the ring-shaped part 71, the transition section 7222 is V-shaped, and the vertex is directed towards the ring-shaped part 71.

[0233] In one embodiment, the pulling section 7221 and the transition section 7222 enclose one or more closed spaces. Regarding the dimensions of the closed space, the radius of the circumscribed circle of the threading loop 722 is greater than or equal to twice the diameter of the rod of the threading loop 722. The key point of this arrangement is that the threading loop 722 has a certain spatial dimension, rather than an opening on the rod.

[0234] Among them, the appendix Figure 3a To be continued Figure 3f and appendix Figure 4a To be continued Figure 4e The same applies to artificial heart valve stents 70, which will not be elaborated here.

[0235] See one embodiment, such as Figures 2h-2j As shown, this embodiment has a structure similar to that of embodiment 2a, including an annular portion 71a and a guide portion 72a. The difference is that the axial direction of the annular portion 71a spans two cells, and in the second region, the inflow end node of the first cell is directly the same as the outflow end node of the second cell, and the leaflet is directly sewn to the second cell; and the end of the outflow side of the threading ring 722 is further converged.

[0236] refer to Figures 2k-2m The embodiment shown includes an annular portion 71b and a guide portion 72b.

[0237] The guide section 72b includes four areas, namely:

[0238] First region: a sparse region, located at the nearest end of the support, used to connect the conveying system. In this invention, the first region is a threading loop 81, including a first cell.

[0239] The second region 82 is a dense area, circumferentially arranged along the annular portion 71b. The second region aligns with the first region and serves as the central area of ​​the guide portion 72b. The second region is used to fix the valve's ear flap and includes at least one second cell 82a. In this embodiment, the second region includes multiple cells, namely the second cell 82a and cells 82b and 82c distributed on either side of the second cell 82a. Along the stent outflow direction, the outflow node of the second cell and the inflow node of the first cell share a common end node.

[0240] The third region 83 and the fourth region 84 are sparse regions. Along the circumference of the annular portion 71, the third region and the fourth region are symmetrically arranged on both sides of the second region. Each region includes at least one cell. In this embodiment, each region includes a third cell 84a, a cell 84b, and a portion of cells 84c. Cell 84c extends vertically across the guide portion and the annular portion.

[0241] In this embodiment, among the first, second, and third cells, the third cell has the largest area, the second cell has the smallest area, and the area of ​​the first cell is between that of the third and second cells.

[0242] The annular portion includes multiple rows of cells, the size of which decreases along the direction of the guide portion.

[0243] Regarding the overall morphology of the artificial heart valve stent 70, please refer to the attached document. Figure 2a Appendix Figure 3a and appendix Figure 4a In the illustrated embodiment, the artificial heart valve stent 70 is generally a tubular structure with a tapered waist 701 in the central axial region. In the figures, the junction of the guide portion 72 and the annular portion 71 is located at the waist 701. Further, the junction of the guide portion 72 and the annular portion 71 is adjacent to the minimum outer diameter of the waist 701; in the embodiment shown, the junction of the guide portion 72 and the annular portion 71 is located at the minimum outer diameter of the waist 701. An opening 724 is formed between adjacent guide portions 72, which widens further from the waist 701 away from the annular portion 71 and opens to the reference figure. Figure 4b and appendix Figure 4c In the embodiment shown, all the leaflets 73 converge at the axis of the annular portion 71 when closed, and the convergence point is located axially adjacent to the waist portion 701 of the annular portion 71.

[0244] In one embodiment, in a row of cells distributed circumferentially along the second end of the annular portion 71, each cell is a quadrilateral, with the two sides closer to the second end being longer than the two sides closer to the first end.

[0245] Reference Appendix Figure 4a To be continued Figure 4e As shown, this application also discloses an artificial heart valve device, including an artificial heart valve stent 70, multiple leaflets 73, and an inner lining, wherein the leaflets and the inner lining constitute a valve assembly, and each leaflet 73 cooperates with each other within a blood flow channel 75 to relatively open or close the blood flow channel 75. The edge of the leaflet 73 includes a fixed edge 731 fixed to the artificial heart valve stent 70, and a free edge 732 that cooperates with adjacent leaflets 73 to control the blood flow channel 75. According to the direction of blood flow control by the leaflet 73, the first end 711 is the outflow side 733, and the second end 712 is the inflow side 734, wherein the two ends of the fixed edge 731 are respectively located at two adjacent guide portions 72, and the middle part of the fixed edge 731 extends to the annular portion 71. In terms of fixing the free edge 732, the two ends of the free edge 732 extend axially toward the outflow side of the stent and are fixed by the lining within a single cell on the guide portion 72. This single cell may be the single cell constituting the central region mentioned above.

[0246] Each guide portion 72 has a symmetry axis 7284 along the circumferential direction of the annular portion 71, and the fixed edge 731 of the two adjacent leaflets 73 intersects at the symmetry axis 7284 of the corresponding guide portion 72. In another aspect, the midpoint of the fixed edge 731 is adjacent to the axial middle part of the annular portion 71.

[0247] In another aspect, the intersection between the guide portion 72 and the annular portion 71 is adjacent to the position of the free edge 732 of the leaflet 73 along the axial direction of the annular portion.

[0248] The adjacent leaflets 73 are connected to each other through the joint portion 735 and fixed to the artificial heart valve support 70, and the position of each joint portion 735 is in the corresponding guide portion 72. In combination with the artificial heart valve support 70 of the two above-mentioned embodiments, the joint portion 735 is fixed in the second unit cell of the second region.

[0249] Referring to the drawings Figure 3a to the drawings Figure 3f In the embodiment shown in the drawings, the inner side of the artificial heart valve support 70 is provided with an inner covering film 74, which is located at the inflow side 734 of the leaflet 73 and is in abutment with the fixed edge 731 of each leaflet 73. The inner covering film 74 extends from the leaflet 73 to the second end 712 of the annular portion 71.

[0250] The artificial heart valve support 70 is also provided with a peripheral leakage prevention component 741 at the inflow side 734 of the leaflet 73. The peripheral leakage prevention component 741 can be exposed to the outer peripheral surface of the artificial heart valve support 70; or an outer covering film can be further wrapped, i.e. the inner covering film 74 and the outer covering film jointly enclose the peripheral leakage prevention component 741 in the radial direction of the tubular structure.

[0251] In another embodiment, the peripheral leakage prevention component 741 is fixed on the outer side of the inner covering film 74, and the peripheral leakage prevention component 741 is in the form of a block with a spacing distribution and the position corresponds to the hollow region of the tubular structure. The peripheral leakage prevention component 741 is in an integral structure with the inner covering film 74, and in the expanded state, the peripheral leakage prevention component 741 extends radially outward from the unit cell at the inflow end side of the annular portion, and is convex outward or flush with the outer surface of the artificial heart valve support 70.

[0252] In another aspect, the inner covering film can be a biological film with biocompatibility or made of PET material, and the peripheral leakage prevention component 741 is made of elastic material and / or absorbs body fluid to expand, or is a porous material, for example, foamed by PU material.

[0253] In an embodiment, the tubular structure has a plurality of unit cell structures arranged in a ring, and the peripheral leakage prevention component is arranged as follows:

[0254] For example Figure 4fThe illustrated anti-leakage member 741 is arranged in one or more rows along the inflow end of the annular portion, and is specifically arranged in a first row of anti-leakage members 7411 close to the inflow side 734, and the first row of anti-leakage members 7411 covers the entire unit cell.

[0255] or as Figure 4g 、 Figure 4h illustrated, a second row of anti-leakage members 7412 and a third row of anti-leakage members 7413 are added adjacent to the inflow side 734 and / or the outflow side 733 of the first row of anti-leakage members 7411. The axial length of the anti-leakage members in the second and third rows is equal to half of the unit cell, and each has a radially outward convex portion 7414 closer to the inflow side of the unit cell. The anti-leakage member 741 itself can be long and wrap around the outer periphery of the artificial heart valve stent 70, or as shown in the attached Figure 3e , be a plurality of spaced blocks fixed to the corresponding hollowed-out area of the tubular structure. The dashed lines in the figure mainly represent the surface extension trend of the anti-leakage member 741.

[0256] To ensure the sealing effect, the anti-leakage member 741 in the expanded state is further convex in the radial direction relative to the tubular structure, and the outer peripheral surface smoothly transitions with the outer peripheral surface of the tubular structure. In the axial direction of the tubular structure, the portion with the maximum convex height is closer to the inflow side. As shown in the figure, the distance between the portion with the maximum convex height of the anti-leakage member 741 and the inflow side of the unit cell in which it is located is S1, and the distance between the portion with the maximum convex height of the anti-leakage member 741 and the outflow side of the unit cell in which it is located is S2. The ratio of S1 to S2 is in the range of 0.2 to 0.8, and the ratio can be preferably in the range of 0.3 to 0.8 in actual products.

[0257] After the anti-leakage member 741 is convex, it can fill the space surrounded by the struts of the unit cell from the area. From the convexity, the anti-leakage member 741 and the strut side edge of the unit cell are in close contact with each other, that is, the lowest position of the anti-leakage member 741 is not lower than the outer peripheral surface of the strut, so as to avoid the gap between the anti-leakage member 741 and the strut side edge, which can absorb the deformation of the anti-leakage member 741 and reduce the sealing effect. The strut side edge is understood to be the side of the strut facing the inside of the unit cell.

[0258] The artificial heart valve device in this embodiment can adopt a dry film preservation method or a wet film preservation method, wherein the dry film preservation method is to preserve the valve leaflets 73 in a non-liquid environment.

[0259] Referring to the attached Figure 5a to the attached Figure 5c , the present application discloses a wire-controlled intervention instrument 90 delivery assembly, which comprises:

[0260] an inner sheath 30 having opposite distal and proximal ends;

[0261] lock seat 31, connected to the distal end of the inner sheath 30;

[0262] the inner core 10, slidingly arranged in the inner sheath 30, one end of the inner core 10 being an extension segment 11 extending out of the distal end of the inner sheath 30, the radial gap of both the inner core 10 and the inner sheath 30 being a threading channel 12;

[0263] the lock piece 13, fixed to the extension segment 11 of the inner core 10 and located on the distal end side of the lock seat 31;

[0264] the pull wire 21, movably arranged in the threading channel 12;

[0265] In the loaded state, the pull wire 21 extends out of the distal end of the inner sheath 30, passes through the threading ring 722 of the interventional instrument 90 and is bound to the lock piece 13, and the lock piece 13 and the lock seat 31 are inserted and matched to limit the pull wire 21 from being unbound.

[0266] The relative movement of the inner core 10 and the inner sheath 30 can realize the relative movement of the lock seat 31 and the lock piece 13, so as to change the constraint state of the pull wire 21. The state of the pull wire 21 can affect the movement process of the interventional instrument 90, especially in the release process of the interventional instrument 90, so as to realize the phased release of the interventional instrument 90 through the pull wire 21. Further, the mutual movement of the tubes can provide a structural basis for the full release and full recovery of the interventional instrument 90, so as to provide a more controllable interventional treatment process, improve the treatment effect and improve the patient experience.

[0267] In the present application, the pull wire 21 mainly realizes the control of the interventional instrument through cooperation with the threading ring 722, and the interventional instrument is optimized in structure through the guide part 72 to improve the compliance of the structure of the interventional instrument in the state change process, avoiding the problems encountered by the interventional instrument in the full recovery process in the prior art.

[0268] The interventional instrument 90 can be an artificial heart valve or a vascular stent, etc. The artificial heart valve can include a stent and valve leaves connected to the stent for controlling the opening and closing of blood flow, and the number of valve leaves is generally two or three. According to needs, a skirt design can be added to the inner side and / or outer side of the stent, and the stent itself can be formed by weaving or cutting of a pipe material. The artificial heart valve can be used to replace the diseased valve in the heart, especially the aortic valve.

[0269] The locking effect of the locking member 13 is embodied as the constraint on the pull wire 21, and it is not difficult to understand that the pull wire 21 will generate a force on the locking member 13, thereby affecting the locking effect. In order to improve the mechanical properties of the locking member 13, with reference to an embodiment, the locking seat 31 is provided with a locking portion matched with the locking member 13, and the locking member 13 is inserted into the locking portion and constrains the movement range of the pull wire 21 in the locked state. The locking portion is a locking hole or a locking groove, and the embodiment takes the locking hole as an example. The locking hole 311 can constrain the locking member 13 on the other side of the fixed structure of the locking member 13, thereby improving the overall mechanical properties of the locking member 13. In structure, as shown in the drawings, the locking hole 311 can be a specific through hole or blind hole for the locking member 13 to pass through; the locking hole 311 can also be a structure capable of improving the positioning effect of the locking member 13, such as a positioning recess or a positioning protrusion, and the structure of the locking member 13 should also be adjusted accordingly.

[0270] In the cooperation process of the locking member 13 and the locking hole 311, it is actually the relative movement process of the inner sheath 30 and the inner core 10. With reference to an embodiment, the locking member 13 moves with the inner core 10 and has the following positions:

[0271] The release position (with reference to the accompanying drawings) Figure 9c , the locking member 13 is released from the locking hole 311 to release the pull wire 21;

[0272] The locking position (with reference to the accompanying drawings) Figure 9b , the locking member 13 is inserted into the locking hole 311 to constrain the pull wire 21.

[0273] The different positions of the locking member 13 are embodied as the constraint on the movement state of the pull wire in the lead-through channel 12. In the embodiment disclosed in the drawings, the actual effect of the locking member 13 is to separate independent constraint spaces in the lead-through channel 12, and when the pull wire 21 is located at a predetermined position (generally achieved through the assembly process), the locking member 13 achieves the constraint effect on the pull wire 21. Correspondingly, the release position is the constraint space in the above-mentioned communication with the lead-through channel 12, and the pull wire 21 can thus move freely to release the interventional instrument 90.

[0274] It is worth noting that the pull wire 21 is not in a completely immovable state during being locked by the locking member 13. The pull wire 21 can realize the following function through its material (such as a deformation material) or size (such as a longer extension length): when the pull wire 21 is constrained by the locking member 13, it can release a predetermined degree of movement stroke of the interventional instrument 90 through its deformation. In combination with the drawings Figure 9bIn the embodiment shown, the half-release of the interventional instrument 90 in the case of the lock piece 13 not being released is achieved by the self-deformation of the pull wire 21, that is, the connecting ear 92 of the interventional instrument 90 is released from the corresponding structure, but the overall shape is still controlled by the pull wire 21. The above setting provides a structural basis for controlling the release process of the interventional instrument 90 by the control of the pull wire 21.

[0275] It is worth noting that the deformation of the pull wire 21 mentioned above refers to the deformation of the extension path of the pull wire 21 rather than the length change caused by material stretching. In the field, in order to achieve the control of the pull wire on the release of the valve, the extension rate of the pull wire should be as small as possible. Other descriptions of the deformation of the pull wire 21 in this paper should also meet the above basic rules.

[0276] As described above, one end of the lock piece 13 is constrained by the lock hole 311, and the other end also needs corresponding structure to achieve stable connection. In an embodiment, the extension segment 11 of the inner core 10 is provided with a mounting seat 131, the lock piece 13 is fixed to the mounting seat 131 and extends in the proximal direction from the mounting seat 131, the mounting seat 131 is provided with a mounting hole 132 for mounting the lock piece 13, the distal end of the lock piece 13 is fixedly inserted into the mounting hole 132, and the proximal end of the lock piece 13 extends out of the mounting hole 132.

[0277] The matching direction of the lock piece 13 and the lock hole 311 in the embodiment is also a noteworthy setting detail. It can be understood that the distal end side of the lock piece 13 is connected with the inner core 10, and the proximal end side of the lock piece 13 extends toward the lock seat 31 and matches with the lock hole 311 with the movement of itself. The lock piece 13 extends from the distal end side to the proximal end side to achieve the matching with the lock hole 311, which can better achieve the compactness of the structure. In the embodiment shown in the drawings, the lock piece 13 and the mounting seat 131 in the lock seat 31 can be arranged inside the interventional instrument 90 in the loaded state, which is located in the bare stent segment of the valve stent. In the loaded state, it fills the large gap between the valve stent and the inner core, preventing the collapse or folding phenomenon caused by the lack of support during the crimping process of the valve stent. On the other hand, by arranging it at the front end, the interference between it and the pull wire tube and the pull wire can be effectively reduced, the overall volume of the delivery assembly can be controlled, and a series of operations in the interventional treatment process can be facilitated.

[0278] More importantly, during the installation of the interventional instrument 90 to the delivery assembly, the lock piece 13 arranged in this direction has better operation convenience. Conversely, if the lock structure is matched from the proximal end to the distal end, it is more cumbersome during the installation of the interventional instrument, and it is very easy to fall off, which leads to rework and affects the production efficiency.

[0279] The installation hole 132 is used to realize the stable cooperation between the lock piece 13 and the installation base 131. In the actual product, the lock piece 13 and the installation hole 132 can be fixedly connected, and considering the production difficulty, the connection can be in the form of bonding or welding. In the assembly process, the structure of the installation hole 132 can better realize the assembly process and improve the production efficiency. On this basis, in an embodiment, the installation hole 132 is open to the peripheral surface of the installation base 131, and the open part can at least accommodate the lock piece 13.

[0280] The open installation hole 132 can facilitate the operation and facilitate the inspection, ensure the stability of the connection, and improve the overall stability of the device. More importantly, the open installation hole 132 can ensure the lock piece 13 to be installed to the bottom of the installation hole 132 from the structure, avoiding the uncertainty caused by the blind hole structure, thereby ensuring the locking distance between the end surface of the lock piece 13 and the lock hole 311.

[0281] In terms of quantity, the lock piece 13 and the lock hole 311 can be adjusted correspondingly. In an embodiment, the lock piece 13 is arranged at intervals in the circumferential direction of the inner core 10, and the lock hole 311 is arranged correspondingly. The adjustment of the quantity of the lock piece 13 and the lock hole 311 can improve the constraint ability of the pull wire 21, thereby realizing the multidimensional control of the interventional instrument 90, which is of great significance in improving the control accuracy. At the same time, the increase in quantity also increases the complexity of the structure, which has a certain influence on the assembly and stability. Therefore, in the specific product, the lock piece 13 is evenly arranged at least three in the circumferential direction of the inner core 10, and the lock hole 311 is arranged correspondingly. In the commonality of the mutual arrangement of the plurality of lock pieces, in an embodiment, the lock piece 13 is a rod. The rod-shaped lock piece 13 has the advantage of simple structure, and can ensure the locking effect while keeping the structure simple by cooperating with the related details of the pull wire 21 below.

[0282] Referring to the accompanying drawings Figure 5fIn the difference of the mutual arrangement of the plurality of locking pieces, at least two locking pieces 13 have different strokes from the release position to the locking position. The stroke refers to the locking distance between the end surface of the locking piece 13 and the locking hole 311, that is, how much distance the end surface of the locking piece 13 needs to pass to enter the locking hole 311. The advantage of this arrangement is that it can achieve different step locking of different locking pieces 13. The main purpose of this technical effect is to improve the installation efficiency of the pull wire 21 and the interventional instrument 90. The interventional instrument 90 and the pull wire 21 are small and complex in structure. When the locking pieces 13 are synchronously locked, the operator needs to complete the synchronous installation of the interventional instrument 90, which is very troublesome for devices with multiple installation points, and seriously affects the assembly efficiency. The present application can realize the phased installation of the interventional instrument 90 through the different step locking of the locking pieces, thereby greatly improving the production efficiency while ensuring the assembly quality.

[0283] The implementation of the locking piece 13 having different strokes from the release position to the locking position has various schemes, for example, through the differential arrangement of the locking hole 311, or through the differential arrangement of the locking piece 13. In an embodiment, at least two locking pieces 13 have different lengths. The locking pieces with different lengths can realize that even if the locking pieces 13 move synchronously, the timing of the cooperation of each locking hole 311 with the corresponding locking piece 13 is different, thereby realizing the above function. Further, the lengths of any two locking pieces are different.

[0284] The pull wire 21 actually interacts with the interventional instrument, so the arrangement details of the pull wire 21 also have a synergistic effect. In an embodiment, the interventional instrument 90 delivery assembly further includes a pull wire assembly, which includes the pull wire 21 and the wire control tube 20. The wire control tube 20 movably sheaths the outside of the inner core 10. One end of the pull wire 21 is the driving end 211 and is connected with the wire control tube 20. The other end of the pull wire is the working end 212 (i.e., the cooperating ring 22 below). In the loaded state of the interventional instrument, the working end 212 is wound to the interventional instrument 90 and cooperates with the locking piece 13.

[0285] The function of the wire control tube 20 is to control the working state of the pull wire 21, especially to control the interventional instrument 90 by controlling the pull wire 21. In the embodiment, the proximal end of the wire control tube 20 is movably arranged to realize the self-driving function. That is, the proximal end of the wire control tube 20 is movably arranged relative to the control handle. In the embodiment, it is manifested that the proximal end of the wire control tube 20 is movably arranged relative to the inner sheath tube. On the specific structure of the wire control tube 20, referring to an embodiment, the wire control tube 20 is movably sleeved between the inner core 10 and the inner sheath tube 30. The arrangement of the wire control tube 20 between the inner core 10 and the inner sheath tube 30 can avoid interference between the wire control tube 20 and the lock seat 31, thereby providing more space for the installation of the interventional instrument 90. The lock seat 31 is further provided with a guide hole 312, and the pull wire 21 extends outwardly from the guide hole 312.

[0286] The wire control tube 20 is a specific tube in the embodiment shown in the drawings, and in principle, the above-mentioned function can be realized by the self-extension of the proximal end of the pull wire 21, that is, by directly operating the proximal end of the pull wire 21 through the control handle 60. Therefore, in the actual product, the specific form of the wire control tube 20 can change. The description below is mainly combined with the product form of the wire control tube 20 in the drawings, and other embodiments are the same, which will not be repeated.

[0287] Referring to the above description, combined with the drawings, Figure 9b In the embodiment, the half release of the interventional instrument 90 is realized by the self-deformation of the pull wire 21 under the condition that the lock piece 13 is not released, that is, the connecting ear 92 of the interventional instrument 90 is released from the corresponding structure, but the overall form is still controlled by the pull wire 21. The above-mentioned arrangement provides a structural basis for controlling the release process of the interventional instrument 90 through the control of the pull wire 21. Referring to an embodiment, the part of the pull wire 21 extending to the distal end side of the fixed disc of the lock seat 31 is a controllable section for controlling the release degree of the interventional instrument, and the length of the controllable section is adjusted through the position adjustment of the wire control tube 20 when the working end 212 of the pull wire 21 is constrained by the lock piece.

[0288] The working state of the lock piece 13 and the working state of the wire control tube 20 can be linked or independent of each other. When they are independent of each other, the wire control tube 20 can control the constrained pull wire 21 to adjust its state by its own movement when the lock piece 13 is not unlocked. On the specific structure of the lock seat, referring to an embodiment, the lock seat 31 includes a guide disc 313, a connecting sleeve 314 and a fixed disc 315 connected in sequence from the distal end to the proximal end, wherein the lock hole 311 is opened in the fixed disc 315, and the guide hole 312 is opened in the guide disc 313 and corresponds to the position of the lock hole 311;

[0289] The locking member 13 passes through the guide hole 316 in the locking position, and is inserted into the corresponding locking hole 311 after passing the periphery of the connecting sleeve 314. The part of the locking member 13 at the periphery of the connecting sleeve 314 serves as a working section, and the working end 212 of the pulling wire 21 is constrained to the working section.

[0290] The guide disc 313 and the fixing disc 315 form a relatively closed small environment in the through channel 12, so as to effectively improve the stability of the locking member 13 in cooperation with the pulling wire 21. Meanwhile, under the action of the guide hole 316, the mechanical properties of the locking member 13 can be effectively improved, so as to ensure that the interventional instrument 90 with high elasticity can be controlled.

[0291] The lock seat 31 can not only guide the locking member 13, but also guide the pulling wire 21. Referring to an embodiment, the lock seat 31 is provided with a plurality of guide holes 312 and a plurality of locking holes 311. Figure 5c In the disclosed embodiment, the fixing disc 315 is provided with a guide hole 312 through which the pulling wire 21 extends from the wire control tube 20 to the distal side of the fixing disc 315 and cooperates with the locking member 13.

[0292] In order to realize specific connection with the wire control tube 20, the pulling wire 21 needs to pass through the fixing disc 315 of the lock seat 31. That is, it can be understood that the pulling wire 21 cooperates with the locking member 13 through the guide hole 312. The guide hole 312 can comb the pulling wire 21, so as to realize stable driving of the wire control tube 20 to the pulling wire 21. Further, the guide hole 312 can adjust the force application position of the pulling wire 21 to the interventional instrument 90 by setting the position of the guide hole 312, so as to better control the interventional instrument 90. Referring to an embodiment, the lock seat 31 is provided with a plurality of locking holes 311 cooperating with the locking member 13, and the guide hole 312 and the locking hole 311 are alternately arranged in the circumferential direction of the fixing disc 315. In addition to the above-mentioned function of adjusting the force application position of the pulling wire 21 to the interventional instrument 90, the guide hole 312 and the locking hole 311 arranged adjacent to each other can also realize compact arrangement of structures on the lock seat 31, and avoid unnecessary mutual interference between adjacent pulling wires 21 (if multiple are provided).

[0293] The constraint path of the pulling wire 21 is actually determined by three positions, that is, how the proximal end of the pulling wire 21 is related to the control handle (in this embodiment, the proximal end of the pulling wire 21 is connected with the wire control tube), how the working end 212 of the pulling wire 21 interacts with the interventional instrument 90, and how the working end 212 of the pulling wire 21 interacts with the locking member 13. The following will be explained separately by way of example. Referring to an embodiment, the pulling wire 21 and the interventional instrument 90 are configured as follows:

[0294] The working end 212 of the pulling wire 21 cooperates with the locking member 13 through the structure of the interventional instrument 90; or

[0295] The interventional instrument 90 is provided with a connecting member 91, and the working end 212 of the pull wire 21 is threaded through the connecting member 91 and matched with the locking member 13.

[0296] The embodiment includes two implementation manners.

[0297] The working end 212 of the pull wire 21 is matched with the locking member 13 via the self structure of the interventional instrument 90 (see the accompanying drawings). Figure 5f The self structure of the interventional instrument 90 can be a hollowed part in the self skeleton of the interventional instrument 90, a hole formed on the skeleton of the interventional instrument 90, or a part extended from the self material of the interventional instrument 90. In an embodiment, the self structure of the interventional instrument is provided with a gap (for example, the hollowed part mentioned above) or an additional threading hole (for example, the threading ring mentioned above).

[0298] In the field of interventional treatment, the interventional instrument 90 can be further provided with a connecting lug 92 to improve the control ability of the delivery assembly on the interventional instrument 90. The number of the connecting lug 92 can be one or more. The connecting lug 92 can be further provided with a threading hole. The connecting member 91 can be arranged to be threaded through the threading holes on the connecting lug 92 in sequence or separately.

[0299] In the preferred embodiment, the working end 212 of the pull wire 21 extends along the interventional instrument 90, passes through the hole at the end of the interventional instrument 90, extends along the direction of the lock seat 31, and is finally sleeved on the lock rod between the guide disc 313 and the fixed disc 315. The advantage of the embodiment is that the direct control of the pull wire 21 on the interventional instrument 90 can be realized, and the number of components is small, which facilitates production and assembly and reduces the possibility of component failure.

[0300] The connecting member 91 can be a self closed loop ring as shown in the accompanying drawings, or other forms, for example, an independent connecting component. In the embodiment shown in the accompanying drawings, the connecting member 91 is a flexible ring. Specifically, the connecting member 91 is a ring. After the interventional instrument is released, the connecting member 91 can remain in the interventional instrument and is not removed with the pull wire 21. It can also be cut off and removed at a later time as needed. Figure 5g Compared with the direct pulling of the interventional instrument 90 by the pull wire 21 itself, the connecting member 91 can be pre-assembled on the interventional instrument, and the pull wire 21 is wound on site during use, which is more convenient to operate and optimizes the stroke of the relative motion pipe.

[0301]

[0302] ​In order to better realize the cooperation of the pull wire 21 and the interventional instrument 90, with reference to an embodiment, the proximal end of the interventional instrument is provided with a plurality of connecting ears 92 with holes, and the wire ring is sequentially threaded through each connecting ear 92. The number of the connecting ears 92 is 2-6, and the sharp corner part of the unit cell of the interventional instrument 90 itself can also be used.

[0303] In the specific arrangement of the wire ring (i.e., the connecting piece 91 in the above), different ways can be adopted to connect and pull the pull wire 21. In the embodiments below, the arrangement details of the pull wire 21 are also adjusted compared with other embodiments, but the basic principle remains unchanged, and therefore will not be described again.

[0304] One end of the pull wire 21 is a driving end 211, which is extended and controlled by a control handle, and the other end of the pull wire 21 is a working end 212 (i.e., the cooperation ring 22 in the following).

[0305] In the arrangement of the pull wire 21 and the wire ring (i.e., the connecting piece 91 in the above), there are various implementation ways, and some arrangement ways are exemplarily shown below. A plurality of connecting points can be arranged on the wire ring to facilitate the connection of the pull wire. The connecting point can be an actual component, which has a volume in space to realize the connection; or the connecting point can be a virtual point, without an actual component, but only representing a position.

[0306] Regarding the specific cooperation process of the pull wire 21 and the lock piece 13, with reference to an embodiment, the end (i.e., the working end 212) of the pull wire 21 cooperating with the lock piece 13 is provided with a cooperation ring 22, and the lock piece 13 penetrates through the cooperation ring 22 to constrain the pull wire 21.

[0307] The advantage of the cooperation ring 22 is that it can facilitate the arrangement of the lock piece 13. In order to realize stable mechanical connection, the lock piece 13 needs to be arranged with a corresponding cooperation structure. In the embodiment, the cooperation ring 22 is formed by the structural advantage of the pull wire 21, which can simplify the arrangement of the lock piece 13. In the embodiment disclosed with reference to the drawings, the lock piece 13 is a rod-shaped structure extending in the axial direction of each pipe, and the lock piece 13 penetrates through the inside of the closed part around the pull wire 21 in the locked position to realize the constraint of the pull wire 21. The closed part can be realized by threading the pull wire 21, or can be provided by the cooperation ring 22.

[0308] Regarding the forming way of the cooperation ring 22, with reference to an embodiment, the cooperation ring 22 is an independent component or is formed by winding the pull wire 21 itself. The arrangement of the independent component facilitates the arrangement of different materials, for example, in some embodiments, the cooperation ring 22 part is arranged with a developing material, which facilitates the real-time control of the interventional process. The form of winding the pull wire 21 itself has the advantages of simple and stable structure, which is convenient for production and assembly.

[0309] Regarding the specific form of winding, with reference to the drawings Figure 5gIn the shown embodiment, the pull wire 21 is a single wire structure between the driving end 211 and the working end 212, and the single wire is wound to form a matching ring at the working end 212. Correspondingly, a matching ring structure can also be provided at the proximal end of the pull wire 21 for easy installation. Alternatively, refer to the embodiment shown in FIG. 2B. Figure 5b In the shown embodiment, the pull wire 21 is a double wire structure, and the double wire is folded back at the working end 212 to form a matching ring at the folded back position. The pull wire 21 has better structural strength in this embodiment. In other embodiments, the pull wire itself is formed by a multi-strand braided structure, and the gap position of the braided structure is used as the matching ring. The gap of the braided structure can be formed by the braiding process or can be formed by operation during assembly.

[0310] As to the setting of how the proximal end of the pull wire 21 is related to the control handle, in addition to the setting mode in which the proximal end of the pull wire 21 is connected to the wire control tube as described above, in an embodiment, the interventional instrument 90 delivery assembly further includes a wire control tube 20, the wire control tube 20 is sleeved outside the inner core 10, one end of the pull wire 21 is the driving end 211, the driving end 211 extends towards the proximal end in the wire control tube 20 and is controlled by the control handle, the other end of the pull wire 21 is the working end 212 (i.e. the matching ring 22 below), and in the loaded state of the interventional instrument, the working end 212 is passed through to the interventional instrument 90 and cooperates with the lock piece 13.

[0311] Compared with the above embodiment, the wire control tube 20 in this embodiment provides an independent movement space for the driving of the pull wire 21, avoiding mutual interference of the pull wires 21 during movement. In a specific driving mode, the proximal end of the pull wire 21 can be directly controlled by the control handle or can be connected to the control handle through an intermediate part.

[0312] The wire control tube 20 can be fixedly arranged in this embodiment. In an embodiment, the proximal end of the wire control tube 20 is fixedly arranged compared with the control handle. Further, the proximal end of the wire control tube 20 is fixedly arranged compared with the inner sheath tube.

[0313] As to the guiding range of the wire control tube 20 to the pull wire 21, in an embodiment, the wall of the wire control tube 20 has a plurality of cavities, and each pull wire is movably guided in the corresponding cavity. The multi-cavity tube arrangement can realize independent guiding of the pull wire 21, thereby further avoiding mutual interference between the pull wires 21.

[0314] The essence of the delivery assembly is that the pipes are nested with each other to achieve different functions. Therefore, in addition to the pipes mentioned above, other pipes can be provided to provide other functions. Referring to an embodiment, the interventional instrument 90 delivery assembly further comprises a bending member 40, which is arranged inside or outside the inner sheath pipe 30, and the distal ends of the bending member 40 and the inner sheath pipe 30 are fixed to each other, and the proximal ends are slidingly fitted to achieve bending of the inner sheath pipe 30 on the distal side.

[0315] The distal ends of the bending member 40 and the inner sheath pipe 30 are fixed to each other, and when the proximal side of one of them is subjected to a force, it will cause the distal ends of the two to have a bending tendency, thereby causing the overall bending of the distal end of the delivery assembly. Referring to the accompanying drawings, Figure 8a to the accompanying drawings, Figure 8c , the delivery process of the interventional instrument 90 can be better achieved. In product design, the form in which the inner pipe actively generates driving force to drive the outer pipe to bend together is called inner bending, and the form in which the outer pipe actively generates driving force to drive the inner pipe to bend together is called outer bending. In actual implementation, the two forms have their own advantages. In this application, the pipe that actively moves is defined as the bending member 40, and the pipe that passively assists the bending member 40 to bend is defined as the inner sheath pipe 30, because the distal ends of the two are fixed to each other, so in the drawings the two show a higher degree of integrity.

[0316] In this embodiment, the bending form is preferably inner bending.

[0317] In terms of the implementation form of the bending member 40, referring to the drawings, the bending member 40 is a pipe arranged inside or outside the inner sheath pipe 30. In other embodiments, the bending member 40 is a rod or a pull wire arranged inside or outside the inner sheath pipe 30. Specifically, the interventional instrument delivery assembly further comprises a bending pull wire, the distal end of which is fixed to the distal end of the inner sheath pipe, and the bending wire extends to the handle inside the inner sheath pipe.

[0318] In addition to being constrained by the pull wire 21, the interventional instrument 90 can also be constrained by the pipe. Referring to an embodiment, the interventional instrument 90 delivery assembly further comprises an outer sheath pipe 50, which is slidingly arranged outside the bending member 40, and the outer sheath pipe 50 moves relative to the interventional instrument 90 to accommodate or release the interventional instrument 90, and the pull wire 21 controls the release of the interventional instrument 90 under the constraint of the wire control pipe 20.

[0319] The outer sheath pipe 50 can switch between wrapping and releasing the interventional instrument 90 by moving relative to the inner core 10. In cooperation with the pull wire 21 above, the outer sheath pipe 50 can also achieve the recovery of the interventional instrument 90, thereby achieving full control of the release process of the interventional instrument 90.

[0320] With reference to an embodiment, the interventional instrument 90 delivery assembly further comprises a sheath tube sleeved outside the outer sheath tube 50 for establishing an interventional channel. The sheath tube establishes a stable channel to provide a stable environment for the treatment process, which is not the focus of the improvement in the present application, and thus will not be described in the drawings and the description.

[0321] The present application also discloses an interventional instrument delivery system, comprising the delivery assembly in the above technical solution and a control handle for driving the delivery assembly, the inner sheath tube, the inner core and the pull wire of the delivery assembly respectively extend to the control handle and relatively move under the driving of the control handle.

[0322] With reference to an embodiment, the control handle 60 has opposite distal and proximal ends for driving a plurality of controlled components to relatively move with each other, and the handle comprises a support body 61 and a plurality of sets of connection assemblies mounted on the support body 61. With respect to the support body 61, each set of connection assemblies is divided into fixed and movable settings, wherein the movable set of connection assemblies comprises threaded transmission, gear and rack transmission and direct transmission according to the transmission mode, and the connection assemblies of each transmission mode are sequentially arranged from the distal end to the proximal end.

[0323] The controlled components can all be tubes and are nested with each other, or can not be in the form of tubes and are only extended to the proximal end of the control handle. The controlled components can all move relative to the control handle, or one or more of them can be fixed relative to the control handle.

[0324] The threaded transmission, the gear and rack transmission and the direct transmission each have advantages. The sequential arrangement of the control handle 60 from the distal end to the proximal end can match the different movement requirements of each tube and the spatial structure of the control handle 60 to realize structural optimization, thereby improving the driving effect of each controlled component under the premise of a certain volume of the control handle 60. The specific structure will be explained below.

[0325] In the overall layout, with reference to an embodiment, the control handle 60 is divided into a threaded matching area 62 on the distal side and a gear and rack matching area 63 on the proximal side in the axial direction, and the connection assemblies adopting threaded transmission and gear and rack transmission are arranged in the corresponding matching areas.

[0326] The thread cooperation and the rack and pinion cooperation have the characteristics of providing stable transmission ratio, especially in the case that the controlled components need accurate control. The advantage of the thread cooperation is that the rotation in the circumferential direction of the control handle 60 can be realized, thereby saving the circumferential space of the handle, but the axial space is required to a certain extent; correspondingly, the advantage of the rack and pinion cooperation is that the axial space of the handle can be saved, but the circumferential space is required to a certain extent. In the embodiment, the advantages and disadvantages of the two cooperation forms are complementary, thereby optimizing the layout form of the control handle 60, and optimizing the layout of the control handle 60 under the premise of ensuring the driving effect. In a specific product, the ratio of the axial length of the thread cooperation area 62 to the axial length of the control handle 60 is greater than or equal to 0.4. It is further preferred that the ratio of the axial length of the thread cooperation area 62 to the axial length of the control handle 60 is greater than or equal to 0.55.

[0327] In the specific arrangement of the thread cooperation area 62, referring to an embodiment, the thread cooperation area 62 is provided with at least two sets of connection assemblies, and is sequentially arranged in the axial direction of the control handle. If the fixed connection assembly is considered, the thread cooperation area 62 can be regarded as being spaced apart, but in the whole, two sets of connection assemblies, i.e. two sets of thread connection assemblies 621, are arranged, which can improve the utilization effect of the circumferential space of the handle, and combined with the ergonomics of the operator, arranging multiple sets of thread connection assemblies 621 on the distal side of the handle can provide better operation experience. Each thread connection assembly 621 is sequentially arranged in the axial direction of the control handle 60 to cooperate with the structure of the axially sleeved controlled component, which can more easily realize the driving of each controlled component.

[0328] In the cooperation of the specific components, referring to an embodiment, the thread transmission connection assembly (also referred to as the thread connection assembly 621) comprises:

[0329] A driving ring 622 rotatably sleeved on the outer periphery of the support body 61;

[0330] A clamping piece 625 slidingly installed on the support body 61, the clamping piece 625 being used for being connected with the controlled component, and the outer periphery of the clamping piece 625 being threadedly cooperated with the inner periphery surface of the driving ring 622.

[0331] Correspondingly, the outer surface of the driving ring 622 is provided with a friction surface for the operator to hold. The driving ring 622 is a driving component, and is rotatably installed on the support body 61 to realize the driving of the clamping piece 625. The support body 61 can be provided with an axial sliding groove, and the clamping piece 625 is slidingly arranged in the axial sliding groove, and the clamping piece 625 is at least partially provided with an external thread structure and is in transmission cooperation with the driving ring 622. The clamping piece 625 is mainly used for fixing the proximal end of the controlled component, and is preferably sealingly connected with the pipe when the controlled component is a pipe.

[0332] Each controlled component needs to be positioned after moving to the appropriate position to avoid being affected by other operations. Referring to an embodiment, a positioning ring 623 is slidably arranged on the outer periphery of the support body 61, and each drive ring 622 has a positioning state of mutual engagement with the positioning ring 623 and a free state of mutual disengagement; in the positioning state, the positioning ring 623 limits the rotation of the drive ring 622.

[0333] The positioning ring 623 can be arranged to be slidably mounted on the support body 61 and can achieve positioning or release of the drive ring 622 by changing its own position.

[0334] It is not difficult to understand that the positioning ring 623 should avoid rotating relative to the support body 61 while sliding on the support body 61. This structure can be achieved by providing a guide sliding groove / slide rail on the support body 61. The cooperation between the positioning ring 623 and the sliding groove / slide rail can be arranged as an interference fit to ensure the friction between them and avoid the failure of the restraining force of the positioning ring 623 on the drive ring 622 or cause accidental locking to affect the operation personnel during the treatment process.

[0335] Referring to the embodiment shown in the drawings, the side of the drive ring 622 facing the positioning ring 623 is provided with a positioning tooth 624, and the drive ring 622 is engaged with the positioning tooth 624 when it is in the positioning state. The advantage of this arrangement is that it can achieve the function of the positioning ring 623 while minimizing the impact on the movement of the drive ring 622, and at the same time optimize the layout of each component on the control handle 60.

[0336] The positioning ring 623 can be provided as one or more. Correspondingly, each drive ring 622 can share or have a separate positioning ring 623. The specific arrangement can be adjusted according to the working conditions or positional relationship. For example, referring to the embodiment shown in the drawings, in the axial direction of the control handle 60, the positioning ring 623 is arranged between the threaded connection assemblies 621. More specifically, the positioning ring 623 is arranged between the drive rings 622 of the threaded connection assemblies 621. The positioning ring 623 arranged between multiple drive rings 622 can provide a structural basis for locking multiple drive rings 622 by a single positioning ring 623, and can also optimize the layout. However, in the scheme shown in the drawings, in the illustrated embodiment, each drive ring 622 uses an independent positioning ring 623 to achieve locking. That is, the positioning ring 623 is provided with at least two. The advantage of arranging each drive ring 622 with a separate positioning ring 623 is that it can avoid interference between them and achieve a more flexible treatment process.

[0337] During the interventional treatment process, the controlled components are taken as an example of a tube, and the tube needs to be vented as needed. Referring to an embodiment, the control handle 60 is provided with an exhaust assembly 64 as a fixedly arranged connecting assembly, and the proximal end of the corresponding controlled component is communicated and fixed to the exhaust assembly. In the illustrated embodiment, the exhaust assembly 64 is fixedly connected with the inner sheath tube 30.

[0338] Each tube is in controlled communication with the exhaust assembly 64 to exhaust air in the tube. The exhaust assembly 64 is usually implemented by injecting liquid (e.g. saline) to achieve the exhaust, and in a specific arrangement, the exhaust assembly 64 can be implemented by the combination of the opening in the tube wall and the relative movement to exhaust each tube. The form of the exhaust assembly 64 shared by each tube can effectively avoid the repeated arrangement of the exhaust assembly 64 and improve the utilization of components in the control handle 60.

[0339] The focus of the exhaust assembly 64 in this application is the layout of the exhaust assembly 64. The positioning ring 623 only needs to use the circumferential space of the control handle 60, so the corresponding structure can be arranged inside the control handle 60. Referring to an embodiment, in the axial direction of the control handle 60, the exhaust assembly 64 is aligned with the positioning ring 623. The coaxial section of the positioning ring 623 and the exhaust assembly 64 can effectively utilize the space in each dimension of the control handle 60 to achieve a three-dimensional layout. As described above, the number of positioning rings 623 can be increased, and when the number of positioning rings 623 is increased, the gap between each positioning ring 623 can provide convenience for the arrangement of the liquid injection port of the exhaust assembly 64. Referring to an embodiment, the positioning ring 623 is provided with at least two, and the exhaust assembly 64 includes a liquid injection port for exhaust, and the liquid injection port extends to the outside of the control handle 60 through the adjacent two positioning rings 623.

[0340] The connecting assembly of the gear and rack cooperation area 63, i.e. the gear connecting assembly 631, is arranged at one end of the support body 61 close to the proximal end side. The gear connecting assembly 631 can improve the utilization effect of the shaft space of the handle, and combined with the ergonomics of the operator, arranging the gear connecting assembly 631 at the proximal end side of the handle can provide a better operation experience. At the same time, the structure of the gear connecting assembly 631 in the circumferential space can improve the driving of the threaded connecting assembly 621 in the above by the operator, and the two cooperate with each other to further improve the operation experience.

[0341] Referring to an embodiment, the gear connecting assembly 631 includes:

[0342] The rack 634 moving in the axial direction of the support body 61, the rack 634 being used to connect with the controlled components;

[0343] And the gear 635 rotatably mounted on the support body 61 and engaged with the rack 634.

[0344] In the embodiment, the gear 635 is the driving component, which can drive the rack 634 to move and thus drive the controlled component. The gear 635 extends at least partially outside the support body 61 or is provided with a corresponding structure extending outside the support body 61. This facilitates the operation and assembly, and also makes full use of the space outside the support body, improving the space utilization.

[0345] In the actual structure, the rack 634 can also be provided with a corresponding structure to improve the cooperation with the controlled component. In an embodiment, the connection mode of the controlled component and the gear is that a base 632 is also provided inside the support body 61, and the rack 634 is fixedly arranged on the base 632.

[0346] The base 632 is slidably arranged inside the support body 61, and the rack 634 is fixedly arranged on the base 632.

[0347] The clamping base 633 is fixedly arranged on the base 632 and is used for sealingly connecting the corresponding controlled component.

[0348] The base 632 is used to provide a stable motion relationship constraint, the clamping base 633 can realize the positioning of the controlled component and the application of the driving force, and the rack 634 is used to bear the driving force from the gear 635.

[0349] As described above for the threaded connection assembly 621, each controlled component needs to be positioned after being moved to the appropriate position to avoid being affected by other operations. In an embodiment, a connection locking mechanism 637 is arranged between the gear 635 and the support body 61 to limit the relative position of the two. The connection locking mechanism 637 is used to position the rotating state of the gear 635, so as to realize the positioning effect of the corresponding controlled component through the transmission relationship between the gear 635 and the rack 634. In a specific structure, the connection locking mechanism 637 includes:

[0350] The first locking tooth 6371 is arranged on the gear 635.

[0351] The second locking tooth 6372 is arranged on the support body 61.

[0352] The retaining assembly 6373 retains the first locking tooth 6371 and the second locking tooth 6372 in the meshing state.

[0353] The gear 635 can slide relative to the support body 61 in the axial direction of the gear 635 to realize the meshing or separation of the first locking tooth 6371 and the second locking tooth 6372.

[0354] The gear 635 keeps the meshing relationship with the rack 634 during the sliding process, so in a certain sense, the meshing width of the rack 634 is greater than the meshing width of the gear 635.

[0355] The function of the retaining assembly 6373 is to ensure the relative position of the gear 635 and the support body 61, thereby maintaining the locking effect. In the specific structure, the retaining assembly 6373 comprises:

[0356] two clamping columns 6374 capable of moving close to or away from the radial direction of the gear 635;

[0357] a clamping groove 6375 provided on the support body 61;

[0358] When the two clamping columns 6374 move to the preset state, they can pass through the constraint of the clamping groove 6375 to release the sliding of the gear 635 relative to the support body 61.

[0359] The retaining assembly 6373 actually functions as a double lock to ensure the stability of the operation of the connection locking mechanism 637. Further, the retaining assembly 6373 also comprises a reset member 6376 provided between the two clamping columns 6374 and used to drive the two clamping columns 6374 to cooperate with the clamping groove to limit the sliding of the gear 635 relative to the support body 61.

[0360] The above describes the arrangement of the connection locking mechanism 637 on the gear 635, and in an embodiment, the gear 635 is linked with a driving part 636 extending radially to the outside of the support body 61. It is not difficult to understand that when the gear 635 is provided with the linked driving part 636, the connection locking mechanism 637 can also be equivalently arranged on the driving part 636, and the specific structure is the same, which will not be described here.

[0361] In an embodiment, the support body 61 comprises an inner skeleton at the distal end and a support cylinder 638 at the proximal end, and the gear rack 634 and the gear 635 are accommodated in the support cylinder, and the gear 635 is linked with a driving part 636 extending to the outside of the support cylinder.

[0362] In an embodiment, the driving part 636 is movably matched with the support body 61, and has a locked position of mutual clamping with the support body 61 and a working position of releasing the clamping, and the connection locking mechanism further comprises a retaining assembly acting between the support body 61 and the driving part 636, and the retaining assembly is used to limit the driving part 636 in the locked position.

[0363] The partial radial extension of the support cylinder forms an outer convex part, and the driving part 636 is arranged outside the outer convex part and is linked with the gear 635, and the connection locking mechanism acts between the driving part 636 and the outer convex part. The driving part 636 is a hollow knob as a whole, and is covered on the outer convex part.

[0364] A part of the driving part 636 is arranged around the outer periphery of the outer convex part, and the inner wall of the part of the driving part 636 and the outer wall of the outer convex part are provided with lock teeth capable of being clamped with each other; for example, comprising:

[0365] The first locking tooth 6371 is arranged on the gear 635.

[0366] The second locking tooth 6372 is arranged on the outer protrusion.

[0367] The driving part 636 is slidingly fitted relative to the support body 61 to switch between the locking position and the working position. The gear 635 is fixedly connected with the driving part 636, and the gear 635 always maintains meshing with the rack 634 during the switching of the driving part 636.

[0368] The rotation axis of the driving part 636 is collinear with the rotation axis of the gear 635, and extends substantially along the radial direction of the control handle. The sliding direction of the driving part 636 during the switching of the driving part 636 is consistent with the direction of the rotation axis of the driving part 636.

[0369] As can be understood from the foregoing, the gear and the rack are in mutual transmission relationship, and therefore the connecting locking mechanism 637 can also be arranged on the rack 634. That is, the connecting locking mechanism 637 is arranged between the rack 634 and the support body 61 to limit the relative position of the rack 634 and the support body 61. In this scheme, the connecting locking mechanism 637 comprises:

[0370] The locking pin 6377 is mounted on the support body 61 and can slide in the radial direction of the support body 61;

[0371] The insertion hole 6378 is arranged on the rack 634 and achieves the locking of the rack 634 and the support body 61 when the insertion hole 6378 is aligned with the locking pin 6377.

[0372] When the locking pin 6377 is fitted with the insertion hole 6378, the relative position of the rack 634 and the support body 61 in the axial direction of the support body 61 is determined, thereby achieving the function of the connecting locking mechanism 637. Similarly to the clamping column 6374 in the foregoing, a corresponding retaining assembly 6373 can also be arranged here. The retaining assembly 6373 here can adopt a self-clamping clamping piece to clamp the locking pin 6377, and the specific structure can be referred to the accompanying drawings, and will not be described here in detail. Figure 7f As can be understood by those skilled in the art, the specific structure will not be described here.

[0373] In addition to the screw fitting and the gear and rack fitting mentioned in the foregoing, in an embodiment, at least one of the controlled components extends out of the proximal side of the control handle 60 to achieve direct transmission. The advantage of direct transmission is that the transmission is direct, and the movement of the controlled components can be conveniently achieved, especially in the case of low movement precision. In this embodiment, the direct transmission is arranged on the proximal side of the control handle 60, which fully utilizes the axial space of the proximal side of the control handle 60 and the structural feature that the controlled components are arranged axially.

[0374] When the controlled components are a plurality of tubes, one of the tubes in the innermost layer can extend out of the proximal end of the control handle 60 to achieve direct transmission. In order to maintain the predetermined position, a positioning mechanism 65 can be arranged at the proximal end of the handle, and as a connecting assembly for direct transmission, the positioning mechanism can lock or release the controlled components, and the released controlled components use direct transmission.

[0375] In other embodiments, a control handle 60 is also disclosed, having opposite distal and proximal ends, for driving five controlled components (hereinafter exemplified by five tubes arranged in an inner and outer sheath) to move relative to each other, the control handle comprising a support body and a plurality of sets of connecting assemblies mounted on the support body, each connecting assembly comprising five sets of connecting assemblies arranged in sequence from the distal end to the proximal end, and in sequence using threaded transmission, fixed arrangement, threaded transmission, rack and pinion transmission, and direct transmission.

[0376] The controlled components include an outer sheath tube, an inner sheath tube, a bending member, a pull wire, and an inner core, which are sequentially linked in sequence at the proximal end to the five sets of connecting assemblies in the control handle.

[0377] The outer sheath tube, the inner sheath tube, the bending member, the pull wire (the proximal end is a wire control tube 20), and the inner core in the controlled components are arranged in sequence from the outside to the inside, and in sequence using threaded transmission, fixed arrangement, threaded transmission, rack and pinion transmission, and direct transmission.

[0378] When the radial positions of the inner sheath tube and the bending member are interchanged, their respective driving modes remain unchanged, but their axial positions at the control handle are interchanged.

[0379] The outer sheath tube 50 is slidably arranged outside the bending member 40, and the outer sheath tube 50 moves relative to the inner sheath tube 30 to release the interventional instrument 90.

[0380] The distal end of the inner sheath tube 30 is fixed with a lock seat 31.

[0381] The inner core 10 is slidably arranged in the inner sheath tube 30, one end of the inner core 10 being an extension segment 11 extending out of the distal end of the inner sheath tube 30, the extension segment 11 being provided with a lock piece 13 cooperating with the lock seat 31, the radial gap between the inner core 10 and the inner sheath tube 30 being a lead-through passage 12 for the pull wire 21, and the lock piece 13 being used to constrain the movement state of the pull wire 21.

[0382] The pull wire itself or through the wire control tube 20 fixed with the pull wire extends from the lead-through passage to the control handle to control the release process of the interventional instrument 90, i.e., slidably arranged between the inner sheath tube 30 and the inner core 10.

[0383] The bending member 40 is arranged inside the inner sheath tube 30, and the distal end portions of the bending member 40 and the inner sheath tube 30 are fixed to each other, and the proximal end is slidably fitted to achieve bending of the inner sheath tube 30 at the distal end side.

[0384] The outer sheath tube 50 is sleeved outside the bending adjusting member 40, and the outer sheath tube 50 moves relative to the inner core 10 to release the interventional instrument 90. The pull wire 21 controls the release process of the interventional instrument 90 under the constraint of the wire control tube 20.

[0385] In the embodiment, the tubes are arranged as follows:

[0386] The inner core 10 is directly driven to extend to the axial end face of the proximal side of the control handle 60;

[0387] The wire control tube 20 is gear-rack matched to extend to the proximal side of the control handle 60;

[0388] The inner sheath tube 30 is fixedly connected with the control handle 60 to serve as the reference for the movement of the tubes;

[0389] The bending adjusting member 40 and the outer sheath tube 50 are respectively threadedly driven to extend to the distal side of the control handle 60.

[0390] The connection modes of the inner sheath tube 30 and the bending adjusting member 40 can be interchanged to adaptively adjust according to the different sleeving relationships.

[0391] The connection modes of the inner sheath tube 30 and the bending adjusting member 40 can be interchanged to adaptively adjust according to the different sleeving relationships. Figure 7a In the disclosed embodiment, the number of tubes can be further increased by increasing the number of connection assemblies, and the integration degree can be improved.

[0392] The connection modes of the inner sheath tube 30 and the bending adjusting member 40 can be interchanged to adaptively adjust according to the different sleeving relationships. Figure 6b The connection modes of the inner sheath tube 30 and the bending adjusting member 40 can be interchanged to adaptively adjust according to the different sleeving relationships.

[0393] The inner core 10 extends through the control handle 60 from the distal end to the proximal end and extends from the end face of the proximal end of the control handle 60. The proximal end of the control handle is sealingly matched with the outer peripheral surface of the inner core 10. The operator can directly drive the inner core through the part of the inner core 10 extending out of the end face of the proximal end of the control handle 60;

[0394] The wire control tube 20 is sleeved on the outer peripheral surface of the inner core 10 and extends to the proximal end of the control handle 60. The wire control tube 20 is connected with the proximal end of the control handle 60 in the form of gear-rack matching. The clamping base in the gear connection assembly is sealingly connected with the outer peripheral surface of the wire control tube 20. The clamping base transmits the movement of the rack to the wire control tube 20;

[0395] The bending adjusting member 40 is arranged on the outer peripheral surface of the wire control tube 20 and extends to the proximal end of the control handle 60 near the middle part. The bending adjusting member 40 is connected with the control handle 60 in the form of thread matching. The clamping member of the thread connection assembly is sealingly matched with the bending adjusting member 40. The clamping member is used to transmit the thread driving force to the bending adjusting member 40;

[0396] The inner sheath 30 is sleeved on the outer periphery of the bending member 40 and extends to the middle part of the control handle 60, and the control handle 60 is connected in a fixed connection mode, wherein the middle part of the control handle 60 is provided with a fixed clamping device which is sealingly and fixedly connected with the inner sheath 30 to determine the relative position of the inner sheath 30 and the control handle 60;

[0397] The outer sheath 50 is sleeved on the outer periphery of the inner sheath 30 and extends to the distal end of the control handle 60, and is connected with the control handle 60 in a threaded connection mode, wherein the clamping piece of the threaded connection assembly is sealingly matched with the outer sheath 50, and the clamping piece is used to transmit the threaded driving force to the outer sheath 50.

[0398] In the above connection mode, the distal end parts of the bending member 40 and the inner sheath 30 are fixed to each other, and when the proximal end side of one of them is subjected to a force, the distal end parts of the two will tend to bend, thereby generating the overall bending of the distal end of the delivery assembly. In product design, the form in which the inner tube member actively generates driving force to drive the outer tube member to bend together is called inner bending, and the form in which the outer tube member actively generates driving force to drive the inner tube member to bend together is called outer bending. In actual implementation, the two forms have their own advantages. In the present application, the tube member which actively moves is defined as the bending member 40, and the tube member which passively assists the bending member 40 to bend is defined as the inner sheath 30. Because the distal end sides of the two are fixed to each other, the two show a strong integrity in the drawings. In the present embodiment, the bending form is preferably inner bending.

[0399] In addition Figure 7c The disclosed control handle 60 embodiment is the same as the above, and the difference lies in that two sets of gear connection assemblies are provided, one set at the most proximal end can be used to drive the inner core 10 or other components that need to move, and the rest of the components can be understood by those skilled in the art according to the description of the present application. The connection relationship between the tube members and the components in the control handle 60 will not be described here.

[0400] In summary, the present application also discloses a wire-controlled delivery system, which comprises an interventional instrument 90 delivery assembly and a control handle 60, the delivery system has opposite distal and proximal ends, and the control handle 60 is used to drive the controlled components in the interventional instrument 90 delivery assembly to move relative to each other, and the controlled components comprise:

[0401] The outer sheath 50;

[0402] The inner sheath 30 is slidingly arranged inside the outer sheath, and the outer sheath moves relative to the inner sheath to release the interventional instrument, and the distal end part of the inner sheath 30 is fixed with a lock seat 31;

[0403] The inner core 10 is slidingly arranged in the inner sheath tube 30, one end of the inner core 10 is an extension section 11 extending out of the distal end of the inner sheath tube 30, the extension section 11 is provided with a locking piece 13 matched with the locking seat 31, the radial gap between the inner core 10 and the inner sheath tube 30 is a lead-through channel 12 for the pull wire 21 to pass through, and the locking piece 13 is used for restricting the movement state of the pull wire 21;

[0404] The pull wire extends from the lead-through channel to the control handle, and is used for controlling the release process of the interventional instrument.

[0405] In the loading state of the interventional instrument 90, the pull wire 21 extends out of the distal end of the inner sheath tube 30, passes around the interventional instrument 90 and is bound to the locking piece 13, and the locking piece 13 is matched and plugged with the locking seat 31 to limit the pull wire 21 from being unbound.

[0406] The control handle 60 of the embodiment can adopt the control handle in the foregoing embodiments according to the specific arrangement of the pipe. The working process of the wire-controlled delivery system will be specifically explained below with reference to the accompanying drawings. When the interventional instrument 90 is delivered into the human body, reference is made to the accompanying drawings. Figure 8a to the accompanying drawings Figure 8c By the movement of the bending member 40, the distal end of the delivery assembly can be bent in the human body, so that the interventional process is realized.

[0407] When the interventional instrument 90 is delivered to the vicinity of the target point, reference is made to the accompanying drawings. Figure 9a to the accompanying drawings Figure 9b By the retraction of the outer sheath tube 50, the interventional instrument 90 can be preliminarily released, wherein Figure 9a is a half-released state, that is, the outer sheath tube 50 is retracted by half. At this time, if an unexpected situation occurs, the interventional instrument 90 can be recovered by the forward movement of the outer sheath tube 50.

[0408] When the outer sheath tube 50 is retracted completely, reference is made to the accompanying drawings. Figure 9b The interventional instrument 90 has been completely unbound from the outer sheath tube 50 but the proximal end is still restricted by the pull wire 21. At this time, if an unexpected situation occurs, the operator can still realize the recovery of the interventional instrument 90 by driving the pull wire 21 through the wire control pipe 20.

[0409] When the release process of the interventional instrument 90 is smooth, reference is made to the accompanying drawings. Figure 9c By the relative movement of the inner sheath tube 30 and the core tube, the locking piece 13 is separated from the locking hole 311, the pull wire 21 is released, the interventional instrument 90 is separated from the delivery assembly at this time, the delivery assembly is retracted, and the interventional process is completed.

[0410] This application also discloses an interventional system, including an interventional device and a delivery assembly. The interventional device includes an annular portion 71, which is a radially deformable structure. The two ends of the annular portion 71 in its own axial direction are a first end 711 and a second end 712, wherein the edge of the first end 711 includes a plurality of unit segments 713 arranged sequentially along the circumference of the annular portion 71.

[0411] Multiple guides 72 are arranged sequentially at intervals along the circumference of the annular portion 71. One side of each guide 72 is connected to a corresponding unit segment 713. The other side of each guide 72 gradually converges to the end 721, and has a threading loop 722 at the end 721.

[0412] The conveying components include:

[0413] The inner sheath has a relatively distal and proximal end;

[0414] Lock seat, connected to the distal end of the inner sheath;

[0415] The inner core is slidably disposed in the inner sheath tube. One end of the inner core is an extension that extends out of the distal end of the inner sheath tube. The radial gap between the inner core and the inner sheath tube is a through-pass channel.

[0416] The locking element is fixed to the extension of the inner core and is located at the far end of the lock base;

[0417] The traction wire is movable within the insertion channel. When the interventional device is loaded, the traction wire extends from the distal end of the inner sheath, passes through the insertion ring 722 of the interventional device, and is then bound to the locking member. The locking member and the locking seat are engaged to prevent the traction wire from detaching from the binding.

[0418] In another embodiment, this application also provides another control handle, such as... Figures 7h-7j As shown, it has a relatively distal end and a proximal end for driving multiple controlled components to move relative to each other. The handle includes a support body 61 and multiple sets of connecting components mounted on the support body 61. Relative to the support body 61, each connecting component is divided into a fixed setting and a movable setting. The movable setting connecting components include threaded transmission, gear and rack transmission and direct transmission according to the transmission method, and the connecting components of each transmission method are arranged sequentially from the distal end to the proximal end.

[0419] The controlled components can all be tubular and nested inside each other, or they can be non-tubular and simply extend to the control handle. The controlled components can be movable relative to the control handle, or one or more of them can be fixed relative to the control handle.

[0420] The threaded transmission, the gear rack transmission and the direct transmission each has advantages, and the control handle 60 is sequentially provided with the different movement requirements capable of cooperating with each pipe fitting from the distal end to the proximal end and the spatial structure of the control handle 60 realizes the structural optimization, so that the driving effect of each controlled component is improved under the premise of the certain volume of the control handle 60. The specific structure will be explained below.

[0421] The control handle 60 is axially divided into the threaded cooperation area 62 located at the distal end side and the gear rack cooperation area 63 located at the proximal end side, and the connection assemblies adopting the threaded transmission and the gear rack transmission are respectively arranged in the corresponding cooperation areas.

[0422] The threaded cooperation and the gear rack cooperation are characterized by being capable of providing a stable transmission ratio, especially in the case that the controlled component needs to be accurately controlled. The advantage of the threaded cooperation is that the rotation in the circumferential direction of the control handle 60 can be realized, so that the circumferential space of the handle is saved, but the axial space has certain requirements. Correspondingly, the advantage of the gear rack cooperation is that the axial space of the handle can be saved, but the circumferential space has certain requirements. In the embodiment, the advantages and disadvantages of the two cooperation forms are complementary, so that the layout form of the control handle 60 is optimized, thereby optimizing the layout of the control handle 60 under the premise of ensuring the driving effect. In the specific product, the ratio of the axial length of the threaded cooperation area 62 to the axial length of the control handle 60 is greater than or equal to 0.4. It is further preferred that the ratio of the axial length of the threaded cooperation area 62 to the axial length of the control handle 60 is greater than or equal to 0.55.

[0423] In the embodiment, the threaded cooperation area 62 is provided with a set of threaded connection assemblies 621, which include: a driving ring 622 rotatably sleeved on the outer periphery of the support body 61; a clamping piece 625 slidably installed on the support body 61, the clamping piece 625 is used to be connected with the controlled component, i.e. the outer sheath 50, and the outer periphery of the clamping piece 625 is in threaded cooperation with the inner periphery surface of the driving ring 622.

[0424] The clamping piece 625 is provided with a mounting hole, the proximal end of the outer sheath 50 is inserted into the mounting hole and is clamped and fixed by the hole wall of the mounting hole. Of course, it can also cooperate with glue or fasteners to prevent loosening.

[0425] Correspondingly, the outer surface of the driving ring 622 is provided with a friction surface for the operator to hold. The driving ring 622 as a driving component is rotatably installed on the support body 61 to drive the clamping piece 625. The support body 61 can be provided with an axial sliding groove, and the clamping piece 625 is slidably arranged in the axial sliding groove. The clamping piece 625 at least partially has an external thread structure and is in transmission cooperation with the driving ring 622. The clamping piece 625 is mainly used to fix the proximal end of the controlled component, and is preferably sealingly connected with the pipe fitting when the controlled component is a pipe fitting.

[0426] Each controlled component needs to be positioned after moving to the appropriate position to avoid being affected by other operations. Referring to an embodiment, a positioning ring 623 is slidably arranged on the outer periphery of the support body 61, and the driving ring 622 has a positioning state of mutual engagement with the positioning ring 623 and a free state of mutual disengagement; in the positioning state, the positioning ring 623 limits the rotation of the driving ring 622.

[0427] The positioning ring 623 can be arranged in a structure that is slidably mounted on the support body 61 and can achieve positioning or release of the driving ring 622 by changing its own position.

[0428] It is not difficult to understand that the positioning ring 623 should avoid rotating relative to the support body 61 while sliding on the support body 61. This structure can be achieved by providing a guide slot / rail on the support body 61. The cooperation between the positioning ring 623 and the slot / rail can be arranged as an interference fit to ensure the friction between them, avoid the failure of the restraining force of the positioning ring 623 on the driving ring 622 or cause accidental locking to affect the operation personnel during the treatment process.

[0429] Referring to Figure 7i The side of the driving ring 622 facing the positioning ring 623 is provided with a positioning tooth 624, and the driving ring 622 is engaged with the positioning tooth 624 when it is in the positioning state. The advantage of this arrangement is that it can achieve the function of the positioning ring 623 while minimizing the impact on the movement of the driving ring 622, and optimizing the layout of each component on the control handle 60.

[0430] Referring to Figures 7i-7m The connecting assembly of the gear and rack cooperation area 63, i.e., the gear connecting assembly 631, is arranged at one end of the support body 61 close to the proximal side. The gear connecting assembly 631 can improve the utilization effect of the shaft space of the handle, and combined with the ergonomics of the operation personnel, arranging the gear connecting assembly 631 at the proximal side of the handle can provide a better operation experience. At the same time, the structure of the gear connecting assembly 631 in the circumferential space can improve the driving of the threaded connecting assembly 621 by the operation personnel, and the two cooperate with each other to further improve the operation experience.

[0431] On the specific components of the gear connecting assembly 631, referring to an embodiment, the gear connecting assembly 631 is a group and is arranged at one end of the support body 61 close to the proximal side. The gear connecting assembly 631 includes:

[0432] A rack 634 that moves in the axial direction of the support body 61, the rack 634 is provided with a clamping base 633 for sealingly connecting the corresponding controlled component, i.e., the wire control pipe 20;

[0433] And a gear 635 that is rotatably mounted on the support body 61 and engaged with the rack 634.

[0434] The clamping base 633 has a mounting hole, the proximal end of the wire control tube 20 is inserted into the mounting hole and is clamped and fixed by the hole wall of the mounting hole, and of course, adhesion or fasteners or the like can be used to prevent loosening.

[0435] In the embodiment, the gear 635 is used as a driving component to drive the rack 634 to drive the controlled component. The gear 635 extends at least partially outside the support body 61 or is provided with a corresponding structure extending outside the support body 61. In order to facilitate operation and assembly, the outer peripheral space of the support body can also be fully utilized to improve space utilization.

[0436] In the actual structure, the rack 634 can also be provided with a corresponding structure to improve the cooperation with the controlled component. In an embodiment, the control handle 60 includes a support cylinder 638 sleeved on the proximal end of the support body 61, and the connection mode of the controlled component and the gear is that:

[0437] a base 632 is further provided in the support body 61 and is slidably installed in the interior of the support cylinder 638, and the rack 634 is fixedly arranged on the base 632;

[0438] a clamping base 633 is installed on the base 632 and is used to connect the proximal end of the wire control tube 20.

[0439] The base 632 is used to provide stable motion relationship constraint, the clamping base 633 can realize the positioning of the wire control tube 20 and the application of driving force, and the rack 634 is used to bear the driving force from the gear 635.

[0440] The clamping base 633 can be fixedly installed on the base 632, and can also have a slight axial movement allowance relative to the base 632, for example, the clamping base 633 and the base 632 are provided with a guide structure (the slide rail 6321 can be seen) matched with each other to guide the axial movement of the clamping base 633 and can limit the radial disengagement from the base 632. Figure 7m The first limiting boss 6323 and the second limiting boss 6324 are arranged on the base 632 and are located on both sides of the clamping base 633, and the distance between the first limiting boss 6323 and the second limiting boss 6324 is slightly greater than the clamping base 633, so that the clamping base 633 can slide slightly, and the second limiting boss 6324 is in the form of an elastic buckle 6322, so as to facilitate the installation of the clamping base 633.

[0441] As with the threaded connection assembly 621 described above, each controlled component needs to be positioned after moving to the appropriate position to avoid being affected by other operations. Referring to an embodiment, the gear 635 is linked with a driving part 636 extending radially to the outside of the support cylinder. The driving part 636 is movably mounted on the support cylinder 638, specifically including that the driving part 636 rotates relative to the support cylinder 638 to drive the gear 635 to rotate, and the driving part 636 slides relative to the support cylinder 638 and a connection locking mechanism 637 is arranged therebetween to limit the rotation of the driving part 636.

[0442] Referring to Figures 7j-7o , a part of the support cylinder 638 extends radially to form an outer protrusion 6382, and the driving part 636 is arranged outside the outer protrusion 6382 and linked with the gear 635. The driving part 636 is a hollow knob as a whole, and is covered by the outer protrusion 6382. The connection locking mechanism 637 includes:

[0443] a first lock tooth 6371 arranged on the driving part 636;

[0444] a second lock tooth 6372 cooperating with the first lock tooth 6371 and arranged on the outer protrusion 6382;

[0445] a retaining assembly 6373 retaining the first lock tooth 6371 and the second lock tooth 6372 in meshing state to limit the rotation of the driving part 636.

[0446] The gear 635 is fixedly connected with the driving part 636 and can slide in the axial direction of itself relative to the support cylinder 638 to realize the meshing or separation of the first lock tooth 6371 and the second lock tooth 6372. It should be noted that the rotation axis of the driving part 636 is collinear with the rotation axis of the gear 635, and extends substantially in the radial direction of the control handle. The sliding direction of the driving part 636 when switching position is consistent with the direction of the rotation axis of the driving part 636. The gear 635 keeps meshing with the rack 634 at all times during the sliding process, so in a certain sense, the gear 635 is always meshing with the rack 634 in its sliding stroke, and the implementation means includes, for example, that the meshing width of the rack 634 is greater than the meshing width of the gear 635.

[0447] In an embodiment, the role of the retaining assembly 6373 is to ensure the relative position of the driving part 636 and the outer protrusion 6382, thereby maintaining the locking effect. In a specific structure, the retaining assembly 6373 includes:

[0448] two clamping columns 6374 movably mounted on the driving part 636, close to or away from in the radial direction of the gear 635;

[0449] a clamping block 6381 arranged on the outer protrusion 6382;

[0450] The reset member 6376 is arranged in the driving part 636 and acts on the two clamping columns 6374 to move them away from each other.

[0451] When the two clamping columns 6374 move away from each other, the end faces of the clamping columns 6374 abut against one end face of the clamping block 6381, and the connection locking mechanism 637 is kept in the locked or released state; when the two clamping columns 6374 move close to each other, the clamping columns 6374 can pass through the constraint of the clamping block 6381 to realize the state switching of the connection locking mechanism 637.

[0452] The holding assembly 6373 actually functions as a double lock to ensure the stability of the connection locking mechanism 637.

[0453] In an embodiment, the gear 635 has a rotating shaft 6351 connected with the driving part 636, and the support cylinder 638 is fixedly provided with a limiting seat 6383 sleeved on the rotating shaft 6351, which can abut against the end face of the gear 635 to limit the disengagement of the driving part 636 and the gear 635 from the support cylinder 638.

[0454] In an embodiment, the catheter assembly further comprises a sheath tube 51 sleeved on the outer sheath tube 50, an inner sheath tube 30 sleeved in the outer sheath tube 50, and an inner core 10 sleeved in the line control tube 20.

[0455] The support body 61 is fixedly provided with a first fixing seat 611 fixedly connected with the inner sheath tube 30, and the first fixing seat 611 is arranged between the clamping member 625 and the clamping base 633 in the axial direction of the support body 61. The proximal end of the support body 61 is slidingly provided with a sliding seat 612 fixedly connected with the inner core 10.

[0456] The control handle 60 is provided with an exhaust assembly 64 as a fixedly arranged connecting assembly, and the proximal end of the corresponding controlled component is communicated with and fixed to the exhaust assembly. The proximal end of the sheath tube 51 is fixedly connected with the exhaust assembly 64.

[0457] The air in the radial gap between the sheath tube 51 and the outer sheath tube 50 can be exhausted to the distal end by injecting liquid (such as normal saline) through the liquid injection hole 641 on the exhaust assembly 64.

[0458] The exhaust of the tubes can also be realized by the combination of the hole opening of the tube wall and the relative movement. The form that the tubes share one exhaust assembly 64 can effectively avoid the repeated arrangement of the exhaust assembly 64 and improve the utilization of the components in the control handle 60.

[0459] Any technical features in the above-described embodiments can be combined in any manner, and for the sake of brevity, the foregoing descriptions of various embodiments do not describe all possible combinations. However, it should be understood that any combination of these technical features, unless specifically excluded, is within the scope of the present disclosure. Technical features in different embodiments can be implemented in the same figure while the figure is regarded as disclosing a combination of the embodiments involved.

[0460] The embodiments described above are only a few of the embodiments of the present application, and the descriptions are specific and detailed, but should not be understood as limiting the scope of the patent application. It should be noted that for ordinary skilled persons in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the scope of the present application.

Claims

1. A prosthetic heart valve device, characterized by, The prosthesis comprises a stent and leaflets in the stent, the stent is tubular in whole and has a hollow region, the inside of the stent is a blood flow channel, the leaflets are multiple, each leaflet is in the blood flow channel and cooperates with each other to open or close the blood flow channel; The stent is further provided with a leakage prevention component on the inflow side of the leaflets, the leakage prevention component is block-shaped and is spacedly distributed and corresponds to the hollow region of the tubular structure; The stent has opposite compressed and expanded states, in the expanded state, the leakage prevention component protrudes outward from the outer circumferential surface of the stent, in the same leakage prevention component, the distance between the maximum outward protruding height and the inflow side of the unit cell is S1, the distance between the maximum outward protruding height and the outflow side of the unit cell is S2, and S1:S2 is 0-0.

8.

2. The prosthetic heart valve device of claim 1, wherein, The stent comprises: An annular part, the annular part is radially deformable, two ends of the annular part in the axial direction are respectively a first end and a second end, and the edge of the first end includes multiple unit segments arranged in sequence along the circumferential direction of the annular part; Multiple guide parts are arranged in sequence along the circumferential direction of the annular part, one side of each guide part is connected to a corresponding unit segment, and the other side of each guide part gradually converges to a terminal end.

3. The prosthetic heart valve device of claim 2, wherein, The guide part and the annular part both have a hollow unit cell structure, the unit cells in the guide part are divided into opposite sparse and dense regions, and at least part of the sparse region is close to the opening position between adjacent two guide parts.

4. The prosthetic heart valve device of claim 3, wherein, The unit cell area of the dense region is 0.3-0.8 times that of the sparse region.

5. The prosthetic heart valve device of claim 2, wherein, The terminal end of the guide part is provided with a threading ring, and the guide part includes four regions, which are: A first region provided with the threading ring; A second region provided along the circumferential direction of the annular part, the second region is aligned with the first region and serves as a central region of the guide part; A third region and a fourth region provided along the circumferential direction of the annular part on both sides of the central region.

6. The prosthetic heart valve device of claim 5, wherein, In the guide part, the edge frame strip is adjacent to the opening position, one end of the edge frame strip is connected to the threading ring, the other end of the edge frame strip is connected to the annular part, and the intersection of the edge frame strip with other frame strips in the tubular structure is not more than two during extension.

7. The prosthetic heart valve device of claim 2, wherein, In the released state, the length of the guide part is L1 and the length of the annular part is L2 along the axial direction of the annular part, and L1:L2=1:0.5-1.5 is satisfied.

8. The prosthetic heart valve device of claim 2, wherein, The guide part extends along the axial direction of the annular part from the annular part, and the extension path first expands outward in the radial direction of the annular part, and then gradually converges after reaching the maximum outer diameter.

9. A prosthetic heart valve device, characterized by The prosthesis comprises a stent and leaflets in the stent, the stent is tubular in whole and has a hollow region, the inside of the stent is a blood flow channel, the leaflets are multiple, each leaflet is in the blood flow channel and cooperates with each other to open or close the blood flow channel; The stent is further provided with a leakage prevention component, the leakage prevention component is block-shaped and is spacedly distributed and corresponds to the hollow region; The stent has opposite compressed and expanded states, in the expanded state, the anti-leakage component protrudes outward from the outer circumferential surface of the stent, in the same anti-leakage component, gradually thickens from the outflow side to the inflow side, and then gradually thins after the highest protruding part, and the part with the highest protruding height is closer to the inflow side.

10. The prosthetic heart valve device of any of claims 1-9, wherein, The inner side of the stent is provided with an inner covering film, and the anti-leakage component is fixed on the outer side of the inner covering film; the inner covering film is located on the inflow side of the valve leaflet and is in butt joint with the fixed edge of each valve leaflet; the inner covering film extends from the valve leaflet to the inflow side of the stent.

11. The prosthetic heart valve device of claim 10, wherein, The inner covering film is a biocompatible biological film or a PET material, and the anti-leakage component is an elastic material and / or an absorbent body liquid expansion, or a porous material.

12. The prosthetic heart valve device of claim 10, wherein, Further comprising an outer covering film for further wrapping the anti-leakage component, and the inner covering film and the outer covering film enclose the anti-leakage component in the radial direction of the tubular structure.

13. The prosthetic heart valve device of claim 10, wherein, The anti-leakage component and the inner covering film are an integral structure.

14. The prosthetic heart valve device of claim 10, wherein, The inner covering film is made of PET material, and the anti-leakage component is made of PU foam.

15. The prosthetic heart valve device of any of claims 1-9, wherein, The artificial heart valve device adopts a dry film preservation method.

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