Prosthetic heart valve device, interventional instrument delivery assembly and control handle

Abstract

The application discloses an artificial heart valve device, an interventional instrument conveying assembly and a control handle, wherein the interventional instrument conveying assembly comprises a lock seat provided with a locking part; a lock piece is located at the distal end side of the lock seat; the lock piece is movable relative to the lock seat and has a release position which is separated from the locking part and a locking position which is inserted into the locking part; a pull wire assembly has a working end at the distal end, and the working end is wound to the interventional instrument in a loaded state and cooperates with the lock piece, wherein the lock piece restricts the pull wire in the locking position and releases the pull wire in the release position. The technical scheme disclosed by the application realizes the whole process control of the artificial heart valve stent through the guide part, especially the threading ring, meanwhile, 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 of the artificial heart valve stent. The operation experience of medical staff is improved, and the treatment effect is improved.

Description

[0001] This application is a divisional application of International Application No. PCT / CN2022 / 101336, with an international filing date of June 24, 2022, entered into the national phase on December 6, 2022, and a national application number of 202280004892.5, and an invention title of “Prosthetic heart valve stent, device, delivery system and interventional system”. TECHNICAL FIELD

[0002] The present application relates to the field of medical devices, and in particular to a prosthetic heart valve stent, device, delivery system and interventional system. BACKGROUND

[0003] With the development of medical conditions, prosthetic heart valves have been used to treat heart valve disorders. Natural heart valves (such as aortic valves, pulmonary valves and mitral valves) 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.

[0004] In the related art, a common treatment for natural heart valve lesions 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 a prosthetic heart valve are adopted. The transvascular technique can achieve less invasion than surgical operation such as open-heart surgery. In the transvascular technique, the prosthetic 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 prosthetic valve reaches the implantation site. The prosthetic valve at the distal end of the catheter expands to its functional size at the site of the diseased natural valve.

[0005] The inventors have found that, in the related art, during implantation of a self-expanding prosthetic valve, when the operator starts to retract the delivery sheath in order to release the prosthetic valve, the prosthetic 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 prosthetic valve tends to cause the prosthetic valve to pop out of the distal end of the delivery sheath very quickly, making it difficult to deliver the prosthetic valve from the sheath in a precise and controlled manner and increasing the risk of trauma to the patient.

[0006] Secondly, in the existing technology valve product, the valve is usually recovered by pressing the valve stent through the forward sheath 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

[0007] To solve the above technical problems, the application discloses an artificial heart valve support, comprising:

[0008] a ring-shaped part, which is a radially deformable structure, and has a first end and a second end at two ends in an axial direction of the ring-shaped part, wherein an edge of the first end includes a plurality of unit segments arranged in sequence in a circumferential direction of the ring-shaped part;

[0009] a plurality of guide parts arranged in sequence and spaced apart in the circumferential direction of the ring-shaped part, one side of each guide part being connected to a corresponding unit segment, and the other side of each guide part gradually converging to a terminal end and having a threading ring at the terminal end.

[0010] Optionally, the artificial heart valve support is based on radial deformation as a whole and has opposite compressed and released states, 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.

[0011] Optionally, L1:L2=1:0.6-1.2.

[0012] Optionally, in 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.

[0013] Optionally, in the released state, the convergence trend of the guide part from the connecting side to the terminal end is uniform convergence.

[0014] Optionally, in the circumferential direction of the ring-shaped part, the length of the connecting side is L3 and L1:L3=0.5-1.5.

[0015] Optionally, the guide part 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.

[0016] Optionally, each guide part is arranged uniformly in the circumferential direction of the ring-shaped part.

[0017] Optionally, between the adjacent two guide parts is an opening part, in the compressed state, the adjacent two guide parts abut against each other to close the opening part.

[0018] Optionally, the guide part and the ring-shaped part both have a hollow cell structure, in the axial direction of the ring-shaped part, the cells in the ring-shaped part are in multiple rows, and the junction part of the guide part and the ring-shaped part is surrounded by the vertices of one row of cells in the circumferential direction.

[0019] Optionally, the guide part extends in the axial direction of the ring-shaped part from the ring-shaped part, the extending path first expands outward in the radial direction of the ring-shaped part, and then gradually converges after reaching the maximum outer diameter.

[0020] Optionally, the axial length of the ring-shaped portion is 1-2.5 unit cells.

[0021] Optionally, the guide portion and the ring-shaped portion each have a hollow unit cell structure, the unit cells in the guide portion are divided into opposite sparse and dense regions, and at least part of the sparse regions is close to the opening between the two adjacent guide portions.

[0022] Optionally, the unit cell area of the dense region is 0.3-0.8 times the unit cell area of the sparse region (understood as the ratio of the areas of individual unit cells, not the areas of the entire sparse and dense regions).

[0023] Optionally, the unit cell area of the dense region is 0.4-0.6 times the unit cell area of the sparse region.

[0024] Optionally, in the guide portion, the edge frame strip adjacent to the opening is connected to the threading ring at one end and to the ring-shaped portion at the other end, and the edge frame strip has no more than two intersection points with other frame strips in the tubular structure during extension.

[0025] Optionally, the edge frame strip is connected to a branch frame strip adjacent to the first end, and the branch frame strip and the edge frame strip are respectively connected to different unit cell vertices on the first end.

[0026] Optionally, the threading ring has a transition section shared with the surrounding unit cells on the side close to the ring-shaped portion, the transition section is V-shaped, and the vertex is directed toward the ring-shaped portion.

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

[0028] Optionally, the transition section and the transition section enclose one or more closed spaces.

[0029] Optionally, the circumscribed circle of the threading ring has a radius greater than or equal to twice the diameter of the rod of the threading ring.

[0030] Optionally, the guide portion includes four regions, respectively:

[0031] The first region is provided with the threading ring.

[0032] The second region is arranged circumferentially along the ring-shaped portion, and the second region and the first region are aligned and serve as the center region of the guide portion.

[0033] The third region and the fourth region are arranged circumferentially along the ring-shaped portion on both sides of the center region.

[0034] Optionally, each of the second, third and fourth regions is provided with only one cell, and one vertex of each cell is connected to the annular portion.

[0035] Optionally, the guide portion extends axially from the annular portion, and the extending path first expands radially outwardly to a maximum outer diameter, and then gradually converges, and the maximum outer diameter is adjacent to the junction between the first region and the second region.

[0036] Optionally, a suture post is connected between the first region and the second region in the direction of the outflow end.

[0037] Optionally, the first region is the threading ring and includes a first cell, and the second region is provided with a second cell, and the outflow end of the second cell shares a node with the inflow end of the first cell, and the second cell is fixedly connected to the valve.

[0038] Optionally, the third and fourth regions are symmetrically arranged on both sides of the central region.

[0039] Optionally, the cells adjacent to the first and second regions in the third and fourth regions are third cells, and among all the cells in the guide portion, the third cells have the largest area.

[0040] Optionally, the area of the first region is greater than the area of the second cell.

[0041] Optionally, the artificial heart valve support is a tubular structure as a whole, and the waist portion is arranged in the axial middle region of the tubular structure.

[0042] Optionally, the junction between the guide portion and the annular portion is located at the waist portion.

[0043] Optionally, the junction between the guide portion and the annular portion is adjacent to the minimum outer diameter of the waist portion.

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

[0045] Optionally, the junction between the guide portion and the annular portion is adjacent to the minimum outer diameter of the waist portion.

[0046] Optionally, the annular portion includes a plurality of rows of cells, and the size of the cells gradually decreases in the direction of the guide portion.

[0047] Optionally, in a row of cells at the second end of the annular portion, each cell is a quadrilateral, and the two sides closer to the second end are longer than the two sides closer to the first end.

[0048] The application also discloses an artificial heart valve device, which comprises an artificial heart valve support and valve leaflets.

[0049] Optionally, the edge of the valve leaflet comprises a fixed edge fixed to the artificial heart valve support and a free edge cooperating with other valve leaflets to control the blood flow channel, according to the control direction of the valve leaflet to 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.

[0050] Optionally, along the annular portion in the axial direction, the junction of the guide portion and the annular portion is adjacent to the position of the free edge of the valve leaflet.

[0051] Optionally, the adjacent valve leaflets are connected to each other through a joint portion and fixed to the support, and the position of each joint portion is in a corresponding guide portion.

[0052] Optionally, along the annular portion in the circumferential direction, each guide portion has a symmetry axis of its own structure, and the fixed edges of the connected two valve leaflets intersect at the symmetry axis of the corresponding guide portion.

[0053] Optionally, the midpoint of the fixed edge is adjacent to the axial middle part of the annular portion.

[0054] Optionally, the inner side of the artificial heart valve support is provided with an inner covering film, and the inner covering film is located at the inflow side of the valve leaflet and is connected to the fixed edge of each valve leaflet.

[0055] Optionally, the inner covering film extends from the fixed edge of the valve leaflet to the second end of the annular portion.

[0056] Optionally, the artificial heart valve support is also provided with a peripheral leakage prevention component located at the inflow side of the valve leaflet.

[0057] Optionally, the peripheral leakage prevention component is fixed to the outer side of the inner covering film, and the peripheral leakage prevention component is in the form of a block and is arranged in a spaced manner and corresponds to the hollow region of the tubular structure.

[0058] Optionally, the peripheral leakage prevention component and the inner covering film are in an integrated structure, and in the expanded state, the peripheral leakage prevention component protrudes outward from the outer peripheral surface of the support.

[0059] Optionally, the inner covering film is made of PET material, and the peripheral leakage prevention component is made of PU material.

[0060] Optionally, the tubular structure has a plurality of unit cell structures arranged in a ring, and in the same peripheral leakage prevention component, the highest protruding part is closer to the inflow side of the unit cell.

[0061] Optionally, in the same circumferential leakage prevention component, the distance between the maximum height of the outer convex and the inflow side of the cell is S1, and the distance between the maximum height of the outer convex and the outflow side of the cell is S2, wherein S1:S2 is 0-0.8 (preferably 0.3-0.8).

[0062] Optionally, in the same circumferential leakage prevention component, gradually thickens from the outflow side to the inflow side, and then gradually thins after the highest outer convex position.

[0063] The application also discloses a delivery assembly of an interventional instrument, which comprises:

[0064] an inner sheath having opposite distal and proximal ends;

[0065] a lock seat connected to the distal end of the inner sheath;

[0066] an inner core slidingly arranged in the inner sheath, one end of the inner core being an extension segment extending out of the distal end of the inner sheath, and the radial clearance of the inner core and the inner sheath being a threading channel;

[0067] a lock piece fixed to the extension segment of the inner core and located on the distal end side of the lock seat;

[0068] a pull wire assembly having a working end at the distal end, the pull wire assembly being movably arranged in the threading channel;

[0069] 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, passes through 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 inserted and matched to limit the pull wire from being unbound.

[0070] Optionally, the lock seat is provided with a locking part matched 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.

[0071] Optionally, the locking part is a lock hole or a lock groove.

[0072] Optionally, the lock piece moves with the inner core and has the following positions:

[0073] a release position, in which the lock piece is released from the lock hole to release the working end of the pull wire;

[0074] a locked position, in which the lock piece is inserted into the lock hole to restrict the working end of the pull wire.

[0075] Optionally, the extension section of the inner core is provided with a mounting seat, the locking member is fixed to the mounting seat and extends towards the proximal end from the mounting seat. The mounting seat is provided with a mounting hole for mounting the locking member, the distal end of the locking member is fixedly inserted into the mounting hole, and the proximal end of the locking member extends out of the mounting hole.

[0076] Optionally, a plurality of locking members are arranged at intervals in the circumferential direction of the inner core, and the locking holes are arranged correspondingly to the locking members.

[0077] Optionally, at least three locking members are uniformly arranged in the circumferential direction of the inner core.

[0078] Optionally, the locking member is rod-shaped.

[0079] Optionally, the strokes of the at least two locking members from the release position to the locking position are different.

[0080] Optionally, the lengths of the at least two locking members are different.

[0081] Optionally, the lengths of any two locking members are different.

[0082] Optionally, the pull wire assembly is one or more pull wires extending from a handle of a delivery system.

[0083] Optionally, the pull wire assembly includes a wire control tube and a pull wire, the wire control tube movably sheaths the outer portion 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 the loaded state of the interventional instrument, the working end is wound to the interventional instrument and cooperates with the locking member.

[0084] Optionally, the proximal end of the wire control tube is movably arranged relative to the control handle.

[0085] Optionally, the wire control tube movably sheaths between the inner core and the inner sheath.

[0086] Optionally, the lock seat is further provided with a guide hole, and the pull wire extends outwardly from the guide hole.

[0087] Optionally, the lock seat includes a guide disc, a connecting sleeve and a fixing disc connected in sequence from the distal end to the proximal end, wherein the locking hole is formed in the fixing disc, and the guide disc is provided with a guide hole corresponding to the position of the locking hole.

[0088] The locking member penetrates through the guide hole and is inserted into the locking hole in the locking position, and the portion of the locking member between the guide disc and the fixing disc serves as a working section, and the working end of the pull wire is constrained in the working section.

[0089] Optionally, the fixing disc is provided with a guide hole for the pull wire to pass through, the pull wire extends to the distal side of the fixing disc via the guide hole from the wire control tube, and cooperates with the lock piece.

[0090] Optionally, the part of the pull wire extending to the distal side of the fixing disc is a controllable section for controlling the release degree of the interventional instrument, and the length of the controllable section is adjusted via the position of the wire control tube when the working end of the pull wire is constrained by the lock piece.

[0091] 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 fixing disc.

[0092] Optionally, the pull wire is wound around the interventional instrument in the following manner:

[0093] The working end of the pull wire cooperates with the lock piece via the structure of the interventional instrument itself; or

[0094] 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 piece.

[0095] Optionally, a gap or an additional through hole is arranged in the structure of the interventional instrument.

[0096] Optionally, a plurality of connecting ears are arranged on the interventional instrument, and the through hole is arranged on the connecting ear.

[0097] Optionally, the connecting piece is a flexible wire ring, and the wire ring passes through the through holes on the connecting ears in sequence.

[0098] Optionally, the working end of the pull wire is provided with a cooperating ring, and the lock piece penetrates the cooperating ring to constrain the pull wire.

[0099] Optionally, the lock piece is in the shape of a rod extending in the axial direction of the pipe, and the lock piece penetrates the inside of the pull wire wound around to achieve the constraint of the pull wire in the locked position.

[0100] Optionally, the closed space is provided by the cooperating ring.

[0101] Optionally, the cooperating ring is an independent component; or is formed by winding the pull wire itself.

[0102] Optionally, the cooperating ring is arranged in at least one of the following manners:

[0103] The pull wire is in 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 cooperating ring;

[0104] Or the pull wire is in a double wire structure, and the double wire is folded back at the working end to form the cooperating ring.

[0105] Or the pull wire itself is formed as a multi-strand braided structure, and the gap part of the braided structure serves as the matching ring.

[0106] 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 interventional instrument is in a loaded state, the working end is passed around the interventional instrument and matched with the lock piece.

[0107] Optionally, the proximal end of the wire control tube is fixedly arranged relative to the control handle.

[0108] Optionally, the wire control tube has a plurality of cavities in the tube wall, and each pull wire is movably threaded in a corresponding cavity.

[0109] Optionally, the interventional instrument delivery assembly further comprises a bending adjusting piece, the bending adjusting piece is arranged inside or outside the inner sheath tube, the bending adjusting piece is fixedly arranged at the distal end of the inner sheath tube and the distal end of the inner core, and the proximal end is slidingly matched to realize bending adjustment of the inner sheath tube on the distal side.

[0110] Optionally, the bending adjusting piece is at least one of a tube, a rod and a pull wire; and the bending adjusting piece is arranged inside or outside the inner sheath tube.

[0111] Optionally, the interventional instrument delivery assembly further comprises an outer sheath tube, the outer sheath tube is slidingly sleeved outside the bending adjusting piece, 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.

[0112] 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.

[0113] 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.

[0114] Optionally, the control handle has opposite distal and proximal ends, is used for driving the inner sheath tube, the inner core and the pull wire to move relatively, comprises a support body and a plurality of sets of connection assemblies mounted on the support body, and each connection assembly is divided into a fixed arrangement and a movable arrangement relative to the support body, wherein the connection assemblies in the movable arrangement comprise screw transmission, gear and rack transmission and direct transmission according to transmission modes, and the connection assemblies in each transmission mode are arranged from the distal end to the proximal end in sequence.

[0115] The application also discloses an intervention system, which comprises 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 channel inside, and the valve leaves are multiple and cooperate with each other in the blood flow channel to open or close the blood flow channel.

[0116] The stent comprises:

[0117] a ring-shaped part, which is a radially deformable structure, and has a first end and a second end at two ends in the axial direction of the ring-shaped part, wherein the edge of the first end comprises multiple unit segments arranged in sequence in the circumferential direction of the ring-shaped part;

[0118] a plurality of guide parts arranged in sequence and spaced apart in the circumferential direction of the ring-shaped 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, which are:

[0119] a first region provided with the threading ring;

[0120] a second region arranged in the circumferential direction of the ring-shaped part, the second region is aligned with the first region and serves as a central region of the guide part;

[0121] a third region and a fourth region arranged on both sides of the central region in the circumferential direction of the ring-shaped part;

[0122] the joint parts are arranged in the corresponding guide parts, and each guide part has a symmetry axis of its own structure, and the fixing edges of the two connected valve leaves intersect at the symmetry axis of the corresponding guide part;

[0123] The delivery assembly comprises:

[0124] an inner sheath tube having opposite distal and proximal ends;

[0125] a lock seat connected to the distal end of the inner sheath tube;

[0126] 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 threading channel;

[0127] a lock piece fixed to the extension segment of the inner core and located on the distal end side of the lock seat, the lock piece being 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 being different;

[0128] The pulling wire assembly has a working end at the distal end thereof, the pulling wire assembly is movably arranged in the lead-through channel, the working end of the pulling wire extends out of the distal end of the inner sheath, passes through the threading ring and is bound to the lock piece, and the lock piece and the lock seat are in plug-in fit to limit the pulling wire assembly from being unbound.

[0129] The technical solution 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 of the artificial heart valve stent. The operation experience of medical staff is improved, and the treatment effect is improved.

[0130] The pulling 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 that a more controllable interventional treatment process is provided, the treatment effect is improved, and the patient experience is improved.

[0131] Specific beneficial technical effects will be further explained in combination with specific structures or steps in the specific embodiments. BRIEF DESCRIPTION OF DRAWINGS

[0132] Figure 1 A schematic diagram of a resistance point of a stent in the prior art during recovery;

[0133] Figure 2a A schematic diagram of an artificial heart valve stent in an embodiment;

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

[0135] A schematic diagram of an artificial heart valve stent in an embodiment; Figure 2c Figure 2a A schematic diagram of the axial length proportion relationship of each part of an artificial heart valve stent in an embodiment;

[0136] Figure 2d A schematic diagram of an artificial heart valve stent in an embodiment; Figure 2e Figure 2a A schematic diagram of an artificial heart valve stent in an embodiment;

[0137] Figure 2f A schematic diagram of the guide part of an artificial heart valve stent in an embodiment; Figure 2a

[0138] A schematic diagram of the threading ring of an artificial heart valve stent in an embodiment; Figure 2g Figure 2a A schematic diagram of the threading ring of an artificial heart valve stent in an embodiment;

[0139] Figure 2h A schematic diagram of the threading ring of an artificial heart valve stent in an embodiment;

[0140] A schematic diagram of the threading ring of an artificial heart valve stent in an embodiment;​​Figure 2i for Figure 2h A front view of an artificial heart valve stent;

[0141] Figure 2j for Figure 2h An enlarged schematic diagram of the middle guide portion;

[0142] Figure 2k A three-dimensional view of an artificial heart valve stent in another embodiment;

[0143] Figure 2l for Figure 2k A front view of an artificial heart valve stent;

[0144] Figure 2m for Figure 2k An enlarged schematic diagram of the middle guide portion;

[0145] Figure 3a A schematic diagram of an artificial heart valve stent in one embodiment;

[0146] Figure 3b 、 Figure 3c as well as Figure 3d for Figure 3a Schematic diagram of artificial heart valve stent from different angles;

[0147] Figure 3e for Figure 3d A magnified schematic diagram of the circle position in FIG.

[0148] Figure 3f for Figure 3a A three-dimensional schematic diagram of an artificial heart valve stent in a top-down view;

[0149] Figure 4a is a schematic diagram of an artificial heart valve device in one embodiment;

[0150] Figure 4b 、 Figure 4c as well as Figure 4d for Figure 4a Schematic diagram of an artificial heart valve device from different perspectives;

[0151] Figure 4e for Figure 4d Middle: Enlarged schematic diagram of artificial heart valve device;

[0152] Figure 4f A schematic diagram of the arrangement of the anti-circular leakage component according to another embodiment;

[0153] Figure 4g A schematic diagram of the arrangement of the anti-circular leakage component according to another embodiment;

[0154] Figure 4h A schematic diagram of the arrangement of the anti-circular leakage component according to another embodiment;

[0155] Figure 4i Structure diagram of the joint part of the artificial heart valve device in an embodiment;

[0156] Figure 4j Perspective view of Figure 4i ;

[0157] Figure 5a Schematic diagram of the distal end side of the delivery assembly in an embodiment of the application;

[0158] Figure 5b Enlarged schematic diagram of the delivery assembly in Figure 5a ;

[0159] Figure 5c Enlarged schematic diagram of the delivery assembly in Figure 5a from another perspective;

[0160] Figure 5d Enlarged schematic diagram of the lock seat and pull wire in the delivery assembly in Figure 5a ;

[0161] Figure 5e Enlarged schematic diagram of the lock seat in the delivery assembly in Figure 5a ;

[0162] Figure 5f Schematic diagram of the different settings of the various locks in the delivery assembly in Figure 5a ;

[0163] Figure 5g Schematic diagram of the cooperation of the pull wire and the interventional instrument through the connecting piece in an embodiment;

[0164] Figure 6a Schematic diagram of the control handle in an embodiment;

[0165] Figure 6b Internal assembly schematic diagram of the control handle in Figure 6a ;

[0166] Figure 6c Internal structure schematic diagram of the control handle in Figure 6a ;

[0167] Figure 6d Internal structure schematic diagram of the control handle from another perspective in Figure 6a ;

[0168] Figure 6e Schematic diagram of the exhaust assembly structure in an embodiment;

[0169] Figure 7a Schematic diagram of the control handle in another embodiment;

[0170] Figure 7b Schematic diagram of the control handle in Figure 7aFig. 6 is a schematic view of the internal assembly of the control handle in Fig. 5;

[0171] Figure 7c Fig. 7 is a schematic view of the internal structure of the control handle in Fig. 5; Figure 7a

[0172] Figure 7d Fig. 8 is a schematic view of the structure of the gear connecting assembly in Fig. 5 from another perspective;

[0173] Figure 7e Fig. 9 is a schematic view of the internal structure of the gear connecting assembly in Fig. 5; Figure 7d

[0174] Figure 7f Fig. 10 is a schematic view of the internal structure of the gear connecting assembly in Fig. 5; Figure 7d

[0175] Figure 7g Fig. 11 is a schematic view of the assembly of each pipe in an embodiment;

[0176] Figure 7h Fig. 12 is a perspective view of the control handle in another embodiment;

[0177] Figure 7i Fig. 13 is an exploded view of the control handle in Fig. 12; Figure 7h

[0178] Figure 7j Fig. 14 is a sectional view of the control handle in Fig. 12; Figure 7h

[0179] Figure 7k Fig. 15 is a schematic view of the partial structure of the control handle in Fig. 12 at the gear and rack; Figure 7i

[0180] Figure 7l Fig. 16 is an exploded view of Fig. 12; Figure 7k

[0181] Figure 7m Fig. 17 is a schematic view of the structure between the gear, rack and clamping base in Fig. 12; Figure 7k

[0182] Figure 7n Fig. 18 is a front view of the control handle in Fig. 12; Figure 7h

[0183] Figure 7o Fig. 19 is a sectional view of the A-A portion in Fig. 12; Figure 7n

[0184] Figure 8a Fig. 20 is a schematic view of the distal side bending of the delivery assembly in an embodiment;

[0185] Figure 8b Fig. 21 is a schematic view of the delivery of the interventional instrument to the target point by the delivery assembly in an embodiment;

[0186] ​​​​​​​​​​Figure 8c Figure 6 is a schematic view of the relative position of the intervention instrument to the target point for adjusting the delivery assembly in an embodiment;

[0187] Figure 9a Figure 7 is a schematic view of the intervention instrument half-released from the delivery assembly in an embodiment;

[0188] Figure 9b Figure 8 is a schematic view of the intervention instrument fully released from the delivery assembly and in a state of preventing the pull wire from loosening in an embodiment;

[0189] Figure 9c Figure 9 is a schematic view of the intervention instrument fully released from the delivery assembly and in a state of releasing the pull wire in an embodiment.

[0190] The reference signs in the drawings are explained as follows:

[0191] 10, inner core; 11, extension section; 12, threading channel; 13, locking piece; 131, mounting seat; 132, mounting hole;

[0192] 20, wire control tube; 21, pull wire; 211, driving end; 212, working end; 22, matching ring;

[0193] 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;

[0194] 40, bending adjusting piece;

[0195] 50, outer sheath tube; 51, sheath tube;

[0196] 60, control handle; 61, support body; 611, fixed seat; 612, sliding seat; 62, threaded matching area; 621, threaded connection assembly; 622, driving ring; 623, positioning ring; 624, positioning teeth; 625, clamping piece; 63, gear and rack matching area; 631, gear connection 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;

[0197] 635, gear; 6351, rotation shaft; 636, driving part; 637, connection locking mechanism; 6371, first locking tooth; 6372, second locking tooth; 6373, retaining assembly; 6374, clamping column; 6375, clamping groove; 6376, reset piece; 6377, locking pin; 6378, insertion hole; 64, exhaust assembly; 641, liquid injection hole; 65, positioning mechanism;

[0198] 638, support cylinder; 6381, clamping block; 6382, outer convex part; 6383, limiting seat;

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

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

[0201] 72, guiding 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;

[0203] 74, inner covering membrane; 741, anti-leakage part; 7411, first circle of anti-leakage parts; 7412, second circle of anti-leakage parts; 7413, third circle of anti-leakage parts; 7414, outer convex site;

[0204] 75, blood flow channel;

[0205] 90, interventional instrument; 91, connecting piece; 92, connecting ear. DETAILED DESCRIPTION

[0206] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present application.

[0207] It should be noted that when an assembly is referred to as being "connected" to another assembly, it can be directly connected to the other assembly or there can be a middle assembly. When an assembly is referred to as being "disposed on" another assembly, it can be directly disposed on the other assembly or there can be a middle assembly.

[0208] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0209] Reference Attachment Figure 1 As shown, when the release position of the stent is inaccurate during surgery and the existing stent released from the sheath needs to be recovered, due to the self-expansion characteristics of the stent, a resistance point 702 that interferes with the delivery component is likely to appear, interfering with the stent recovery process).

[0210] like Figure 2a As shown in Figures 3a and 4a, the present application discloses an artificial heart valve device, including an artificial heart valve stent and multiple leaflets and a membrane located inside the stent. The artificial heart valve stent is a tubular structure as a whole, and has a compressed state and an expanded state. The interior of the stent is a blood flow channel, and the leaflets are in the blood flow channel and cooperate with each other to relatively open or close the blood flow channel.

[0211] Reference Attachment Figure 2a To the attached Figure 2g , discloses an artificial heart valve stent 70, comprising:

[0212] The annular portion 71 is located at the inflow end of the stent and can also be referred to as the inflow end region. The annular portion 71 is a radially deformable structure and is composed of a plurality of compressible cells. The two ends of the annular portion 71 in its own axial direction are respectively 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 in sequence along the circumference of the annular portion 71. The axial length of the annular portion 71 is the length of 1.5 cells.

[0213] Multiple guide portions 72 are located at the outflow end of the stent, which can also be called the outflow end area; they are arranged in sequence along the circumference of the annular portion 71, and one side of each guide portion 72 is connected to a corresponding unit segment 713, and the shape of the other side of each guide portion 72 gradually converges to the end 721, and the end 721 is provided with a threading ring 722.

[0214] The present application utilizes the guide portion 72, particularly the threading ring 722, to achieve fully controlled release of the prosthetic heart valve stent 70, including the retrieval of the valve stent completely free of the sheath, thereby improving surgical implant accuracy. Furthermore, the configuration and extended shape of the guide portion 72 minimize the impact of the self-expansion characteristics of the prosthetic heart valve stent 70 on its retrieval.

[0215] Regarding the overall proportions of the guide portion 72, refer to the attached Figure 2b to Figure 2cIn the illustrated embodiment, the artificial heart valve stent 70 as a whole exhibits relative compression and release states based on radial deformation. In the released state, the guide portion 72 has a length L1 and the annular portion 71 has a length L2, with the length of the annular portion 71 being the axial direction, and the ratio L1:L2 is 1:0.5-1.5. In certain products, L1:L2 is 1:0.6-1.2.

[0216] Regarding the connection form of the guide portion 72, refer to the attached Figure 2f In the embodiment shown, along the axial direction of the annular portion 71, one side of each guide portion 72 is a connecting side 723 that interfaces with the corresponding unit segment 713, and the connecting sides 723 of two adjacent guide portions 72 are connected to each other. In an expanded embodiment, the connecting sides 723 of two adjacent guide portions 72 can also be arranged with a gap. Regardless of how the adjacent guide portions 72 are arranged, from the overall arrangement of the guide portions 72, the guide portions 72 are evenly arranged along the circumference of the annular portion 71, for example, Figure 2b As shown, along the circumference of the annular portion 71, the length of the connecting side 723 is L3 and satisfies L1:L3=0.5~1.5. The length L3 of the connecting side 723 should be understood as the length of the arc on the circumference of the annular portion 71. Figure 3a To the attached Figure 3f And attached Figure 4a To the attached Figure 4e The same is true for the artificial heart valve stent 70 in the embodiment, which will not be described in detail here. In terms of the number of guide portions 72, referring to an embodiment, there are N guide portions 72, N is 2, 3, 4, 5 or 6, and the central angle corresponding to the connecting side 723 of each guide portion 72 is 360 degrees / N.

[0217] Regarding the extension trend of the guide portion 72, refer to the attached Figure 2a and attached Figure 3b In the embodiment shown, in the released state, the convergence trend of the guide portion 72 from the connecting side 723 to the end 721 is uniform. Figure 4a In the embodiment shown, in the released state, the guide portion 72 has a convergence trend from the connecting side 723 to the end 721 that is first small, then large, and finally small. When considering the convergence trend, the projection shape of the guide portion 72 in the radial direction of the annular portion 71 should be used as the basis for judgment. The uniform convergence mentioned in this embodiment should be understood as an overall trend, and it does not exclude the possibility that the edge of the guide portion 72 may be provided with protrusions or depressions at certain locations. When viewed from other directions, the extension trend of the guide portion 72 can be set separately, see the attached figure. Figure 2d , Attachment Figure 3c And attached Figure 4b In the illustrated embodiment, the guide portion 72 extends from the annular portion 71 axially along the annular portion 71 , and the extension path first expands radially outward from the annular portion 71 , reaches the maximum outer diameter 7281 , and then gradually converges.

[0218] As can be readily understood from the foregoing, there is a certain gap between the distal ends 721 of the guide portions 72, with an opening 724 formed between two adjacent guide portions 72. In the compressed state, the adjacent guide portions 72 abut against each other, closing the opening 724. As the artificial heart valve stent 70 switches between different states, the size of the opening 724 also changes synchronously.

[0219] In a specific implementation form, the guide portion 72 and the annular portion 71 both have a hollow cell structure. Along the axial direction of the annular portion 71, the cells in the annular portion 71 are multiple circles, and the junction between the guide portion 72 and the annular portion 71 is surrounded by the vertices of one circle of cells.

[0220] The guide portion 72 and the annular portion 71 of the cell structure can better adapt to the state switching of the artificial heart valve stent 70, and can also finely adjust the mechanical properties of the artificial heart valve stent 70 through the setting of the cell structure. The axial length of the annular portion 71 is 1 to 2.5 cells. Figure 2i As shown, the axial length of the annular portion 71 spans two cells, as shown in FIG. Figure 2l As shown, 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, a diamond grid as shown in the drawings.

[0221] like Figure 2a-2d , the guide portion 72 and the annular portion 71 both have a hollow cell structure, and the cells in the guide portion 72 are divided into relatively sparse areas 725 and dense areas 726, and at least a part of the sparse areas 725 is close to the opening between the two adjacent guide portions 72. The sparse areas and dense areas in this application are relative. The sparse areas refer to cells with a larger area, and the dense areas refer to cells with a relatively smaller area, that is, the cell area in the sparse areas is larger than the cell area in the dense areas. For example, the cell area corresponding to the sparse area 725 is larger than the cell area in the dense area 726; cells with different degrees of sparseness can finely adjust the mechanical properties of various parts of the guide portion 72, thereby improving the compliance of the guide portion 72 and providing a smoother operating experience during the release and recovery process.

[0222] For the specific layout, please refer to the attached Figure 2f , Attachment Figure 3a And attached Figure 4c In the embodiment shown, the guide portion 72 includes four enclosed areas 727, namely:

[0223] First region 7271: The first region is located at the most proximal end of the stent and is used to connect to the delivery system. In the present invention, the first region is a threading ring 722 and includes a first unit cell;

[0224] The second area 7272 is a dense area 726 arranged circumferentially along the annular portion 71, and is aligned with the first area 7271 and serves as a center area 7275 of the locating portion 72; the second area is used to fix the ear of the valve and includes at least one second unit cell; in the embodiment, the second area includes only one unit cell, i.e., a second unit cell, and in other embodiments, the second area can include multiple unit cells. In the direction of the outflow end of the stent, the outflow end node A of the second unit cell is connected to the inflow end node B of the first unit cell through a suture column AB, and a suture hole is arranged on the suture column AB, through which the valve leaflet is fixed, and the first connecting strip is parallel to the longitudinal axis of the stent.

[0225] The third area 7273 is a sparse area 725 arranged circumferentially along the annular portion 71 and located on one side of the center area 7275; in the embodiment, the third area includes only one third unit cell, and in other embodiments, the third area can include multiple unit cells.

[0226] The fourth area 7274 is a sparse area 725 arranged circumferentially along the annular portion 71 and located on the other side of the center area 7275; in the embodiment, the fourth area includes only one fourth unit cell, and in other embodiments, the fourth area can include multiple unit cells.

[0227] In the embodiment, the third unit cell and the fourth unit cell have the same size and the largest area, the first unit cell has the smallest area, and the second unit cell has an area between that of the third unit cell and the first unit cell.

[0228] In the implementation, the dense area 726 of the second area 7272 can be realized by increasing the number of unit cells in the same area, or by reducing the corresponding area under the premise of the same number of unit cells. In principle, it is realized that more ribs are arranged in the unit area in the dense area 726. In an embodiment, the unit cell area of the dense area 726 is 0.3-0.8 times the unit cell area of the sparse area 725. In a specific product, the unit cell area of the dense area 726 is 0.4-0.6 times the unit cell area of the sparse area 725.

[0229] Referring to FIG. 1, the stent 70 includes a plurality of unit cells arranged circumferentially along the annular portion 71, and the plurality of unit cells are arranged in a plurality of areas, including a first area 7271, a second area 7272, a third area 7273, and a fourth area 7274. Figure 2f In the embodiment shown in the drawings, the second area 7272, the third area 7273, and the fourth area 7274 each include only one unit cell, and one vertex of each unit cell is in abutment with the annular portion 71. In the drawings, the unit cells of the third area 7273 and the fourth area 7274 have the same or similar shape, and the shapes of the unit cells of the third area 7273 and the fourth area 7274 are different from the shape of the unit cell of the second area 7272 to form the change in density.

[0230] Referring to FIG. 1, the stent 70 includes a plurality of unit cells arranged circumferentially along the annular portion 71, and the plurality of unit cells are arranged in a plurality of areas, including a first area 7271, a second area 7272, a third area 7273, and a fourth area 7274. Figure 2fIn the shown embodiment, the guide portion 72 extends from the annular portion 71 in an axial direction of the annular portion 71, and the extending path first expands radially outwardly, and then converges gradually after reaching a maximum outer diameter 7281, which is adjacent to the junction between the first region 7271 and the second region 7272. Referring to the accompanying drawings, the maximum outer diameter 7281 is shown in FIG. 2. Figure 2f In the shown embodiment, the guide portion 72 has an edge frame 7282 adjacent to the opening portion, and the edge frame 7282 has one end connected to the threading ring and the other end connected to the annular portion 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 accompanying drawings, the edge frame 7282 has one intersection point. Referring to the accompanying drawings, the edge frame 7282 is shown in FIG. 2. Figure 2f In the shown embodiment, the edge frame 7282 is connected to a branch frame 7283 adjacent to the first end 711, and the branch frame 7283 and the edge frame 7282 are connected to different vertices of the unit cell at the first end 711, respectively.

[0231] The full-process control of the prosthetic heart valve support 70 requires the cooperation of the threading ring 722. Referring to the accompanying drawings, the threading ring 722 is shown in FIG. 2. Figure 2g In the shown embodiment, the threading ring 722 has a pulling section 7221 on the side away from the annular portion 71, and the pulling section 7221 is arc-shaped. The threading ring 722 has a transition section 7222 on the side close to the annular portion 71, and the transition section 7222 is V-shaped with the vertex pointing towards the annular portion 71.

[0232] In the arrangement of the pulling section 7221, referring to an embodiment, the pulling section 7221 and the transition section 7222 enclose one or more closed spaces. In the size of the closed space, the radius of the circumscribed circle of the threading ring 722 is greater than or equal to twice the diameter of the rod of the threading ring 722, and the focus of the arrangement is that the threading ring 722 has a certain size in space, rather than the opening on the rod.

[0233] In the accompanying drawings, Figure 3a to the accompanying drawings, Figure 3f and the accompanying drawings, Figure 4a to the accompanying drawings, Figure 4e The prosthetic heart valve support 70 in the accompanying drawings has the same reason, and will not be described here.

[0234] Referring to an embodiment, as Figure 2h~Figure 2j shown, the embodiment has a structure similar to that of the embodiment 2a, including the annular portion 71a and the guide portion 72a, and the difference is that the annular portion 71a spans 2 unit cells in the axial direction, and in the second region, the inflow end node of the first unit cell is directly the same as the outflow end node of the second unit cell, and the leaflets are directly sewn to the second unit cell.

[0235] and the end of the outflow side of the threading ring 722 is further convergent.

[0236] Referring toFigure 2k~Figure 2m The embodiment shown includes an annular portion 71b and a guide portion 72b.

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

[0238] The first area is a sparse area located at the most proximal end of the stent and is used to connect to the delivery system. In the present invention, the first area is a threading ring 81, which includes a first unit cell.

[0239] Second region 82 is a dense area located circumferentially along annular portion 71b. It aligns with the first region and serves as the center of guide portion 72b. This region, used to secure the valve's tab, includes at least one second cell 82a. In this embodiment, the second region comprises multiple cells: second cell 82a and cells 82b and 82c located on either side of second cell 82a. Along the stent's outflow end, the outflow node of the second cell shares a common end node with the inflow node of the first cell.

[0240] The third and fourth regions 83 and 84b are sparsely spaced areas, symmetrically arranged on either side of the second region along the circumference of the annular portion 71. Each region includes at least one cell. In this embodiment, each region includes a third cell 84a and a cell 84b, and a portion of a cell 84c. Cell 84 longitudinally spans 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 first cell has an area between the third cell and the second cell.

[0242] The annular portion includes a plurality of rows of cells, and the size of the cells decreases along the guide portion.

[0243] Regarding the overall shape of the artificial heart valve stent 70, refer to the attached Figure 2a , Attachment Figure 3a And attached Figure 4a In the embodiment shown, the artificial heart valve stent 70 is a tubular structure as a whole, and the axial middle area of ​​the tubular structure has a waist 701 with a reduced diameter. In the accompanying drawings, the junction of the guide portion 72 and the annular portion 71 is located at the waist 701. Furthermore, 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 in the accompanying drawings, the junction of the guide portion 72 and the annular portion 71 is located at the minimum outer diameter of the waist 701. Between two adjacent guide portions 72 is an opening portion 724, and the opening portion 724 is further expanded from the waist 701 to the back of the annular portion 71 and is open. Figure 4b And attached Figure 4cIn the embodiment shown, when all the leaflets 73 are closed, they meet at the axis of the annular portion 71, and the meeting point is located adjacent to the waist portion 701 in the axial direction of the annular portion 71.

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

[0245] Reference is made to the accompanying drawings Figure 4a Reference is made to the accompanying drawings Figure 4e As shown, the application also discloses an artificial heart valve device, which comprises an artificial heart valve support 70, a plurality of leaflets 73, and an inner covering 74, wherein the leaflets and the inner covering form a valve assembly, and each leaflet 73 cooperates with each other in the blood flow passage 75 to open or close the blood flow passage 75. The edge of the leaflet 73 comprises a fixed edge 731 fixed to the artificial heart valve support 70, and a free edge 732 cooperating with the adjacent leaflet 73 to control the blood flow passage 75, and according to the control direction of the leaflet 73 to the blood flow, 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 located in the two adjacent guide portions 72, and the middle part of the fixed edge 731 extends to the annular portion 71. Wherein the fixing of the free edge 732, the two ends of the free edge 732 extend towards the outflow side in the axial direction of the support, and are fixed by the covering in a cell on the guide portion 72. The cell can be the cell constituting the central region mentioned above.

[0246] Along the circumference of the annular portion 71, each guide portion 72 has a symmetry axis 7284 of its own structure, and the fixed edges 731 of the two connected leaflets 73 meet 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] Wherein along the axial direction of the annular portion, the junction between the guide portion 72 and the annular portion 71 is adjacent to the position of the free edge 732 of the leaflet 73.

[0248] And 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 embodiments mentioned above, the joint portion 735 is fixed in the second cell of the second region.

[0249] Reference is made to the accompanying drawings Figure 3a Reference is made to the accompanying drawings Figure 3f In the embodiment shown, the inner side of the artificial heart valve support 70 is provided with an inner covering 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 74 extends from the second end 712 of the annular portion 71 to the leaflet 73.

[0250] The artificial heart valve stent 70 is further provided with a peripheral leakage prevention member 741 located on the inflow side 734 of the valve leaflet 73. The peripheral leakage prevention member 741 may be exposed on the outer circumference of the artificial heart valve stent 70 or may be further covered with an outer covering, i.e., the inner covering 74 and the outer covering enclose the peripheral leakage prevention member 741 in the radial direction of the tubular structure.

[0251] In another embodiment, the peripheral leakage prevention components 741 are fixed to the outside of the inner covering 74. The peripheral leakage prevention components 741 are spaced apart and positioned to correspond to the hollowed-out areas of the tubular structure. The peripheral leakage prevention components 741 and the inner covering 74 are integrally formed. In the expanded state, the peripheral leakage prevention components 741 extend radially outward from the cells on the inflow side of the annular portion, protruding from the outer circumference of the artificial heart valve stent 70 or flush with the outer surface of the stent.

[0252] The inner film can be made of a biocompatible biological membrane or PET material, and the anti-leakage component 741 is made of elastic material and / or swells by absorbing body fluids, or porous material, such as PU foam.

[0253] In one embodiment, the tubular structure has a multi-channel cell structure, and the anti-leakage components are arranged in the following manner:

[0254] like Figure 4f The anti-leakage components 741 are arranged in one or more rows along the circumference of the inflow end of the annular portion, specifically in the first circle of anti-leakage components 7411 close to the inflow side 734. The first circle of anti-leakage components 7411 covers the entire unit cell.

[0255] or as Figure 4g 、 Figure 4h As shown, a second ring of anti-circumferential leakage components 7412 and a third ring of anti-circumferential leakage components 7413 are added adjacent to the inflow side 734 and / or outflow side 733 of the first ring of anti-circumferential leakage components 7411. The axial length of the second and third rings of anti-circumferential leakage components is equal to half a cell, and both have a radially convex portion 7414, which is closer to the inflow side of the cell. The anti-circumferential leakage component 741 itself can be long and wrapped around the periphery of the artificial heart valve stent 70, or as shown in the attached figure, Figure 3e In the figure, the plurality of blocks are spaced apart and fixed in the hollow area corresponding to the tubular structure. The dotted line in the figure is mainly used to indicate the surface extension trend of the anti-leakage component 741.

[0256] To ensure the plugging effect, the anti-leakage component 741 in the expanded state further protrudes radially relative to the tubular structure, and the outer peripheral surface thereof is smoothly connected to the outer peripheral surface of the tubular structure. In the axial direction of the tubular structure, the position with the maximum protrusion height is closer to the inflow side. As shown in the figure, the distance between the position with the maximum protrusion height of the anti-leakage component 741 and the inflow side of the unit cell in which the anti-leakage component 741 is located is S1, and the distance between the position with the maximum protrusion height of the anti-leakage component 741 and the outflow side of the unit cell in which the anti-leakage component 741 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 component 741 protrudes outward, the space surrounded by the rod members of the unit cell can be filled in terms of area. In terms of the degree of protrusion, the anti-leakage component 741 abuts against the side edge of the rod member of the unit cell, that is, the lowest position of the anti-leakage component 741 is not lower than the outer peripheral surface of the rod member, so as to avoid the gap between the anti-leakage component 741 and the side edge of the rod member, which can absorb the deformation of the anti-leakage component 741 and reduce the plugging effect. The side edge of the rod member is understood as the side of the rod member facing the inside of the unit cell.

[0258] The artificial heart valve device in the embodiment can be stored in a dry film mode or a wet film mode. In the dry film mode, the valve leaflets 73 are stored in a non-liquid environment.

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

[0260] An inner sheath 30 has opposite distal and proximal ends.

[0261] A lock seat 31 is connected to the distal end of the inner sheath 30.

[0262] An inner core 10 is slidingly arranged in the inner sheath 30. One end of the inner core 10 is an extension segment 11 extending out of the distal end of the inner sheath 30. The radial gap between the inner core 10 and the inner sheath 30 is a lead-through channel 12.

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

[0264] A pull wire 21 is movably arranged in the lead-through 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 intervention instrument 90, and is bound to the lock piece 13. The lock piece 13 is inserted and matched with the lock seat 31 to limit the pull wire 21 from being unbound.

[0266] The relative movement of the inner core 10 and the inner sheath tube 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, and 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 cooperates with the threading ring 722 to realize the control of the interventional instrument, and the structure of the guide part 72 is optimized to improve the compliance of the interventional instrument in the state change process, thereby 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 to control 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 a diseased valve in the heart, especially an aortic valve.

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

[0270] In the cooperation process of the lock piece 13 and the lock hole 311, it is actually the relative movement process of the inner sheath tube 30 and the inner core 10. In one embodiment, the lock piece 13 moves with the inner core 10 and has the following positions:

[0271] The release position (refer to the accompanying drawings) Figure 9c The lock piece 13 is released from the lock hole 311 to release the pull wire 21.

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

[0273] The different positions of the locking element 13 specifically constrain the movement of the pull wire within the insertion channel 12. In the embodiment disclosed in the accompanying drawings, the locking element 13 effectively functions by creating an independent restraining space within the insertion channel 12. When the pull wire 21 is in a preset position (generally achieved during the assembly process), the locking element 13 constrains the pull wire 21. Accordingly, the release position, i.e., the restraining space mentioned above, communicates with the insertion channel 12, allowing the pull wire 21 to move freely, thereby releasing the interventional instrument 90.

[0274] It is worth noting that the pull wire 21 is not completely immobile during the process of being locked by the locking element 13. The pull wire 21 can achieve the following functions through its own material (e.g., deformable material) or size (e.g., longer extension length): when the pull wire 21 is constrained by the locking element 13, it can release a preset degree of movement of the interventional instrument 90 through its own deformation. Figure 9b In the illustrated embodiment, the deformation of the pull wire 21 allows for partial release of the interventional instrument 90 without releasing the locking element 13. Specifically, the connecting ears 92 of the interventional instrument 90 are released from the corresponding structure, but the overall configuration of the interventional instrument 90 is still controlled by the pull wire 21. This configuration provides a structural foundation for controlling the release of the interventional instrument 90 through the control of the pull wire 21.

[0275] It is worth noting that the deformation of the puller wire 21 mentioned above refers to the deformation along its extension path, not the change in length due to material stretching. In the art, to achieve valve release control with the puller wire, the puller wire's elongation should be minimized. Other descriptions of the deformation of the puller wire 21 herein should also comply with the aforementioned basic rules.

[0276] As described above, one end of the locking element 13 is constrained by the locking hole 311, and the other end also requires a corresponding structure to achieve a stable connection. Referring to one embodiment, the extension section 11 of the inner core 10 is provided with a mounting seat 131. The locking element 13 is fixed to the mounting seat 131 and extends proximally from the mounting seat 131. The mounting seat 131 is provided with a mounting hole 132 for mounting the locking element 13. The distal end of the locking element 13 is inserted and fixed in the mounting hole 132, and the proximal end of the locking element 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 towards the lock seat 31 and matches with the lock hole 311 along the movement of the lock piece 13. The lock piece 13 extends from the distal end side to the proximal end side to realize the matching with the lock hole 311, which can better realize 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 loading state, which is located in the bare stent section of the valve stent, and in the loading state, it plays a role in filling 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 locking 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 mounting hole 132 functions to realize the stable matching of the lock piece 13 and the mounting seat 131. In actual products, the lock piece 13 and the mounting hole 132 can be arranged in a fixed connection, and considering the production difficulty, they can be selected in the form of bonding or welding. In the assembly process, the structure of the mounting hole 132 can better realize the assembly process and improve the production efficiency. On this basis, in an embodiment, the mounting hole 132 is open to the peripheral surface of the mounting seat 131, and the open part can at least accommodate the lock piece 13.

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

[0281] In quantity, the lock piece 13 and the lock hole 311 can also be adjusted accordingly. Referring to an embodiment, the lock piece 13 is arranged in plurality in the circumferential direction of the inner core 10, and the lock hole 311 is arranged correspondingly with the lock piece 13. The adjustment in quantity of the lock piece 13 and the lock hole 311 can improve the restraining ability of the pull wire 21, thereby realizing the multi-dimensional 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 certain influence on assembly and stability. Therefore, in the specific product, the lock piece 13 is arranged in at least three in the circumferential direction of the inner core 10, and the lock hole 311 is arranged correspondingly with the lock piece 13. In the mutual arrangement of the plurality of lock pieces, referring to an embodiment, the lock piece 13 is rod-shaped. The rod-shaped lock piece 13 has the advantage of simple structure, and can ensure the locking effect while being simple in structure, in cooperation with the related details of the pull wire 21 below.

[0282] Referring to the drawings Figure 5f In the difference of the mutual arrangement of the plurality of lock pieces, referring to an embodiment, the stroke of at least two lock pieces 13 from the release position to the locked position is different. The "stroke" here refers to the locking distance between the end face of the lock piece 13 and the lock hole 311, in other words, how much distance the end face of the lock piece 13 needs to pass to enter the lock hole 311. The advantage of this setting is that it can realize the different step locking of different lock 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, and when the lock pieces 13 are locked synchronously, the operator needs to complete the synchronous installation of the interventional instrument 90, which is very troublesome for the device 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 lock pieces, thereby greatly improving the production efficiency while ensuring the assembly quality.

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

[0284] The actual mechanical interaction is the pull wire 21, so the details of the pull wire 21 also have a synergistic effect. Referring to 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 sheathed outside the inner core 10, one end of the pull wire 21 is the driving end 211 and 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), and the working end 212 is cooperated with the lock piece 13 after passing through the interventional instrument 90 in the loaded state.

[0285] The wire control tube 20 functions to control the working state of the pull wire 21, and can especially control the interventional instrument 90 by controlling the pull wire 21. In the embodiment, the wire control tube 20 is movably arranged to realize its driving function. That is, the proximal end of the wire control tube 20 is movably arranged compared with the control handle. In the embodiment, it is manifested as that the proximal end of the wire control tube 20 is movably arranged compared with 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 sheathed 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 realizing 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 outward 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, it can be realized by the proximal end of the pull wire 21 extending by itself, that is, by directly operating the proximal end of the pull wire 21 through the control handle 60 to realize the above-mentioned function. Therefore, in the actual product, the specific form of the wire control tube 20 can change. The description below mainly combines 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, combining the drawings Figure 9b In the 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 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. When they are independent, the wire control tube 20 can control the adjustment of the state of the constrained pull wire 21 by its own movement when the lock piece 13 is not unlocked. In 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 lock piece 13 penetrates the guide hole 316 in the locked position, inserts into the corresponding lock hole 311 after passing through the periphery of the connecting sleeve 314, and the part of the lock piece 13 at the periphery of the connecting sleeve 314 serves as a working section, and the working end 212 of the pull wire 21 is constrained in the working section.

[0290] The guide disc 313 and the fixed disc 315 form a relatively closed small environment in the through channel 12, thereby effectively improving the stability of the lock piece 13 in cooperation with the pull wire 21. At the same time, under the action of the guide hole 316, the mechanical properties of the lock piece 13 can be effectively improved to ensure that the interventional instrument 90 with high elasticity can be controlled.

[0291] In addition to providing guidance to the lock piece 13, the lock seat 31 can also provide guidance to the pull wire 21. Referring to the accompanying drawings, Figure 5c In the disclosed embodiment, the fixed disc 315 is provided with a guide hole 312 for the pull wire 21 to pass through, and the pull wire 21 extends from the wire control tube 20 to the distal side of the fixed disc 315 through the guide hole 312 and cooperates with the lock piece 13.

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

[0293] The constraint path of the puller wire 21 is actually determined by three locations: how the proximal end of the puller wire 21 establishes a relationship with the control handle (in this embodiment, the proximal end of the puller wire 21 is connected to the wire control tube), how the working end 212 of the puller wire 21 interacts with the interventional instrument 90, and how the working end 212 of the puller wire 21 interacts with the locking element 13. The following will illustrate each of these separately. Regarding how the working end 212 of the puller wire 21 interacts with the interventional instrument 90, referring to one embodiment, the puller wire 21 and the interventional instrument 90 are configured as follows:

[0294] The working end 212 of the puller wire 21 is coupled with the locking element 13 after passing through the structure of the interventional instrument 90; or

[0295] The interventional instrument 90 is provided with a connecting piece 91 , and the working end 212 of the puller wire 21 passes through the connecting piece 91 and then cooperates with the locking piece 13 .

[0296] This embodiment includes two implementation methods.

[0297] "The working end 212 of the pull wire 21 is matched with the locking element 13 after passing through the structure of the interventional instrument 90" (see Appendix Figure 5f ) can be a hollowed portion within the framework of the interventional device 90, a hole formed in the framework of the interventional device 90, or a portion formed by extending the material of the interventional device 90. In one embodiment, the structure of the interventional device 90 has a gap (e.g., the hollowed portion mentioned above) or an additional threading hole (e.g., the threading loop mentioned above) within its structure.

[0298] In the field of interventional therapy, the interventional instrument 90 may also be provided with connecting ears 92 to enhance the controllability of the delivery assembly over the interventional instrument 90. The number of connecting ears 92 may be one or more. The connecting ears 92 may also be provided with through-holes. The connector 91 may be provided as through-holes that are sequentially or individually provided on the connecting ears 92.

[0299] In the preferred embodiment, the working end 212 of the puller wire 21 extends along the interventional instrument 90, passes through the hole at the end of the interventional instrument 90, extends along the lock seat 31, and is finally mounted on the lock rod located between the guide plate 313 and the fixed plate 315. The advantages of this embodiment are that the puller wire 21 can directly control the interventional instrument 90, and the number of parts is small, which facilitates production and assembly while reducing the possibility of component failure.

[0300] "The interventional device 90 is provided with a connector 91" (see attached Figure 5gThe connecting member in the above can refer to the self-closed wire ring shown in the drawings, or other forms of settings, such as independent connecting components. In the embodiment shown in the drawings, the connecting member 91 is a flexible wire ring. Specifically, the connecting member 91 is a wire 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.

[0301] Compared with the above, the pull wire 21 directly pulls the interventional instrument 90 itself, the connecting member 91 can be pre-assembled on the interventional instrument, and the mutual winding with the pull wire 21 is more convenient for operation and optimizes the stroke of the relative motion pipe.

[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 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 setting of the wire ring (i.e. the connecting member 91 in the above), different ways can be used to connect with the pull wire 21, and in the following embodiment, the setting details of the pull wire 21 are also adjusted compared with other embodiments, but the basic principle does not change, so it will not be expanded.

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

[0305] In the setting of the pull wire 21 and the wire ring (i.e. the connecting member 91 in the above), there are many implementation ways, and the following exemplary shows several setting ways. The wire ring can be provided with several connection points for convenient connection of the pull wire. The connection point can be an actual component, which has a volume in space to realize the connection; the connection point can also be a virtual point, and there is no actual component, only a position.

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

[0307] The advantage of the mating ring 22 is that it facilitates the installation of the locking element 13. To achieve a stable mechanical connection, the locking element 13 requires a corresponding mating structure. In this embodiment, the structural advantages of the pull wire 21 are utilized to form the mating ring 22, which simplifies the installation of the locking element 13. In the embodiment disclosed with reference to the accompanying drawings, the locking element 13 is a rod extending axially in each pipe. In the locked position, the locking element 13 extends through the enclosed area around the pull wire 21 to constrain the pull wire 21. The enclosed area can be achieved by the insertion of the pull wire 21 or provided by the mating ring 22.

[0308] Regarding the formation of the engagement ring 22, referring to one embodiment, the engagement ring 22 is a separate component or formed by winding the puller wire 21 itself. The independent component configuration facilitates the use of different materials. For example, in some embodiments, the engagement ring 22 is made of a developing material to facilitate real-time control of the interventional procedure. The self-winding configuration of the puller wire 21 offers the advantages of a simple and stable structure, facilitating production and assembly.

[0309] For the specific form of winding, refer to the attached Figure 5g In the embodiment shown, the pull wire 21 is a single wire structure from the driving end 211 to the working end 212, and the single wire is wound around the working end 212 to form a matching loop. Accordingly, a corresponding matching loop structure can also be provided at the proximal end of the pull wire 21 to facilitate installation. Figure 5b In the illustrated embodiment, the puller wire 21 is a double-strand structure that folds back at the working end 212, forming a mating loop. This embodiment provides the puller wire 21 with enhanced structural strength. In other embodiments, the puller wire itself is a multi-strand braided structure, with gaps in the braid serving as mating loops. The gaps in the braided structure can be formed during the braiding process or by manipulation during assembly.

[0310] Regarding the setting of how the proximal end of the pull wire 21 establishes a relationship with the control handle, in addition to the setting method of connecting the proximal end of the pull wire 21 with the wire-controlled tube in the above text, you can also refer to an embodiment in which the interventional instrument 90 delivery assembly also includes a wire-controlled tube 20, which is sleeved on the outside of the inner core 10, and one end of the pull wire 21 is a driving end 211, which extends proximally in the wire-controlled tube 20 and is controlled by the control handle, and the other end of the pull wire 21 is a working end 212 (i.e., the mating ring 22 below). When the interventional instrument is in the loaded state, the working end 212 is wrapped around the interventional instrument 90 and mated with the locking member 13.

[0311] Compared with the above embodiment, the drive of the pull wires 21 in the line control tube 20 in the embodiment provides independent movement space, avoiding mutual interference of the pull wires 21 in the movement process. 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 line control tube 20 can be fixedly arranged in the embodiment. In an embodiment, the proximal end of the line control tube 20 is fixedly arranged compared with the control handle. Further, the proximal end of the line control tube 20 is fixedly arranged compared with the inner sheath tube.

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

[0314] The essence of the delivery assembly is that the pipe fittings are nested with each other to realize different functions. Therefore, in addition to the pipe fittings mentioned above, the delivery assembly can be provided with other pipe fittings to provide other functions. In an embodiment, the delivery assembly of the interventional instrument 90 further includes a bending adjustment member 40, which is arranged inside or outside the inner sheath tube 30. The bending adjustment member 40 and the inner sheath tube 30 are fixed to each other at the distal end positions and are slidably connected at the proximal ends to realize bending adjustment of the inner sheath tube 30 at the distal end side.

[0315] The bending adjustment member 40 and the inner sheath tube 30 are fixed to each other at the distal end positions. When the proximal end side of one of them receives a force, the distal ends of the two will tend to bend, thereby causing overall bending adjustment of the distal end of the delivery assembly. Referring to FIG. 1, the bending adjustment member 40 is arranged inside the inner sheath tube 30, and the bending adjustment member 40 and the inner sheath tube 30 are fixed to each other at the distal end positions. When the proximal end of the inner sheath tube 30 receives a force, the distal end of the inner sheath tube 30 will tend to bend, thereby causing overall bending adjustment of the distal end of the delivery assembly. Figure 8a Figure 8c , the delivery process of the interventional instrument 90 can be better realized. In product design, the form in which the inner pipe fitting actively generates driving force to drive the outer pipe fitting to bend together is called inner bending, and the form in which the outer pipe fitting actively generates driving force to drive the inner pipe fitting to bend together is called outer bending. In actual implementation, the two forms have their own advantages. In the present application, the pipe fitting that actively moves is defined as the bending adjustment member 40, and the pipe fitting that passively assists the bending adjustment member 40 to realize bending is defined as the inner sheath tube 30. Because the distal end sides of the two are fixed to each other, the two are shown to have higher integrity in the drawings.

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

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

[0318] In addition to being constrained by the pull wire 21, the interventional instrument 90 can also be constrained by the tube. Referring to an embodiment, the interventional instrument 90 delivery assembly further comprises an outer sheath tube 50, the outer sheath tube 50 is sleeved outside the bending member 40, and the outer sheath tube 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 tube 20.

[0319] The outer sheath tube 50 can switch between wrapping and releasing the interventional instrument 90 through its own movement relative to the inner core 10. In cooperation with the pull wire 21 described above, the outer sheath tube 50 can also achieve the recovery of the interventional instrument 90, so that the release process of the interventional instrument 90 is controllable throughout.

[0320] Referring to an embodiment, the interventional instrument 90 delivery assembly further comprises a sheath tube, the sheath tube is sleeved outside the outer sheath tube 50, and is used to establish an interventional channel. The stable channel established by the sheath tube can provide a stable environment for the treatment process. In the present application, the sheath tube is not the focus of improvement, so it will not be described in the drawings and the text.

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

[0322] Referring to an embodiment, the control handle 60 has opposite distal and proximal ends, and is used to drive a plurality of controlled components to move relative to each other. 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 connection assembly is divided into fixed and movable settings. The movable connection assemblies include threaded transmission, gear and rack transmission, and direct transmission according to the transmission mode, and the connection assemblies of each transmission mode are arranged from the distal end to the proximal end in sequence.

[0323] The controlled components can all be tubes, and can be nested inside and outside each other, or can not be in the form of tubes, but only extend 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 rack transmission and the direct transmission each has advantages. The control handle 60 is sequentially provided with the different movement requirements of the pipe fittings from the distal end to the proximal end, and the spatial structure of the control handle 60 is optimized, so that the driving effect of each controlled component is improved under the premise of a certain volume of the control handle 60. The specific structure will be explained below.

[0325] In the overall layout, in an embodiment, the control handle 60 is divided into a threaded matching area 62 at the distal end and a gear rack matching area 63 at the proximal end in the axial direction. The threaded transmission and the gear rack transmission are respectively arranged in the corresponding matching areas.

[0326] The threaded matching and the gear rack matching have the characteristics of being able to provide a stable transmission ratio, especially in the case of precise control of the controlled components. The advantage of the threaded matching is that rotation can be realized in the circumferential direction of the control handle 60, thereby saving the circumferential space of the handle, but there is a certain requirement for the axial space. Correspondingly, the advantage of the gear rack matching is that the axial space of the handle can be saved, but there is a certain requirement for the circumferential space. In this embodiment, the advantages and disadvantages of the two matching forms are complementary, thereby optimizing the layout form of the control handle 60, so as to optimize 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 threaded matching 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 matching 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 threaded matching area 62, in an embodiment, the threaded matching area 62 is provided with at least two sets of connection assemblies, which are sequentially arranged in the axial direction of the control handle. If the fixed connection assemblies are considered, the threaded matching area 62 can be regarded as being spaced apart, but as a whole, two sets of connection assemblies, i.e. two sets of threaded connection assemblies 621, are arranged. The threaded connection assemblies 621 can improve the utilization effect of the circumferential space of the handle. Combined with the ergonomics of the operator, arranging multiple threaded connection assemblies 621 at the distal end of the handle can provide better operation experience. Each threaded connection assembly 621 is sequentially arranged in the axial direction of the control handle 60 to match the structure of the axial sleeve of each controlled component, so that the driving of each controlled component can be more easily realized.

[0328] In the specific component matching, in an embodiment, the threaded transmission connection assembly (also referred to as the threaded connection assembly 621) comprises:

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

[0330] The clamping member 625 is slidably mounted on the support body 61 and is used to connect with the controlled component. The outer periphery of the clamping member 625 is threadedly engaged with the inner periphery 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 rotatably mounted on the support body 61 and serves as a driving component to drive the clamping member 625. The support body 61 can be provided with an axial sliding slot, and the clamping member 625 is slidably arranged in the axial sliding slot. The clamping member 625 is at least partially provided with an external thread structure and is in transmission cooperation with the driving ring 622. The clamping member 625 is mainly used to fix the proximal end of the controlled component. When the controlled component is a pipe, the clamping member 625 is preferably in sealed butt joint with the pipe.

[0332] After each controlled component is moved to a suitable position, it needs to be positioned to avoid being affected by other operations. In an embodiment, a positioning ring 623 is slidably arranged on the outer periphery of the support body 61, and each driving ring 622 has a positioning state of being engaged with the positioning ring 623 and a free state of being disengaged from the positioning ring 623. In the positioning state, the positioning ring 623 limits the rotation of the driving ring 622.

[0333] The positioning ring 623 can be slidably arranged on the support body 61 and can be positioned or released 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 realized by providing a guide sliding slot / rail on the support body 61. The cooperation between the positioning ring 623 and the sliding slot / rail can be provided 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 driving ring 622 or cause accidental locking to affect the operator to perform the treatment process.

[0335] In the embodiment shown in the drawings, the driving ring 622 is provided with a positioning tooth 624 on the side facing the positioning ring 623, 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 realize the function of the positioning ring 623 while reducing the influence on the movement of the driving 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 in one or more. Correspondingly, each driving ring 622 can share or separately provide the positioning ring 623. The specific arrangement mode can be adjusted according to the working condition or the positional relationship. For example, referring to the embodiment shown in the accompanying 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 driving rings 622 of the threaded connection assemblies 621. The arrangement of the positioning ring 623 in multiple driving rings 622 can provide a structural basis for the locking of multiple driving 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 driving ring 622 is locked by using an independent positioning ring 623. That is, the positioning ring 623 is provided in at least two. The advantage of arranging the positioning ring 623 for each driving ring 622 is that it can avoid interference between them and can achieve more flexible treatment process.

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

[0338] Each pipe is controlled to communicate with the exhaust assembly 64 to exhaust the air in the pipe. The exhaust assembly 64 is usually used to inject liquid (such as normal saline) to achieve emptying. In the specific arrangement, the exhaust assembly can realize the emptying of each pipe by combining the relative movement with the opening of the pipe wall of each pipe. The form that each pipe shares an exhaust assembly 64 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 the present 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 in the interior of 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 is arranged, which can effectively utilize the space in each dimension of the control handle 60 and realize the three-dimensional layout. As described above, the number of positioning rings 623 can be increased. When the number of positioning rings 623 is increased, the gap between each positioning ring 623 can provide convenience for the injection port of the exhaust assembly 64. Referring to an embodiment, the positioning ring 623 is provided in at least two, and the exhaust assembly 64 includes an injection port for exhausting air. The injection port extends to the outside of the control handle 60 through the gap between the two adjacent positioning rings 623.

[0340] The connecting assembly of the gear and rack matching 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 in combination 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 described above by the operator, and the two cooperate with each other to further improve the operation experience.

[0341] In the specific components of the gear connecting assembly 631, with reference 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 is used to connect with the controlled component;

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

[0344] In this embodiment, the gear 635 acts as a driving component and can drive the rack 634 to move to realize the driving of the controlled component. At least a part of the gear 635 extends to the outside of the support body 61 or is provided with a corresponding structure extending to the outside of the support body 61. In order to facilitate operation and assembly, the outer circumferential space of the support body can also be fully utilized to improve 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. With reference to an embodiment, the connection mode of the controlled component and the gear is that a base 632 is also provided in the support body:

[0346] The base 632 is slidingly installed inside the support body 61, and the rack 634 is fixedly arranged on the base 632;

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

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

[0349] As the threaded connection assembly 621 in the foregoing, each controlled component needs to be positioned after moving to the appropriate position, so as not to be affected by other operations. Referring to 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 on the corresponding controlled component through the transmission relationship of the gear 635-rack 634. In a specific structure, the connection locking mechanism 637 includes:

[0350] a first locking tooth 6371 arranged on the gear 635;

[0351] a second locking tooth 6372 arranged on the support body 61,

[0352] a retaining assembly 6373 for retaining the first locking tooth 6371 and the second locking tooth 6372 in meshing state;

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

[0354] The gear 635 maintains 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 role of the retaining assembly 6373 is to ensure the relative position of the gear 635 and the support body 61, so as to maintain the locking effect. In a specific structure, the retaining assembly 6373 includes:

[0356] Two clamping columns 6374 capable of approaching or moving away in the radial direction of the gear 635;

[0357] A clamping groove 6375 arranged on the support body 61;

[0358] When the two clamping columns 6374 move to a 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 plays a role of a double lock to ensure the stability of the operation of the connection locking mechanism 637. Further, the retaining assembly 6373 further includes a reset member 6376 arranged between the two clamping columns 6374 and used to drive the two clamping columns 6374 to cooperate with the clamping groove 6375 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. In one embodiment, the gear 635 is linked with a driving portion 636 extending radially to the outside of the support body 61. It is understood that when the gear 635 is provided with the linked driving portion 636, the connection locking mechanism 637 can also be equivalently arranged on the driving portion 636. The specific structure is the same, and will not be described here.

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

[0362] In one embodiment, the driving portion 636 is movably connected to the support body 61 and has a locked position in which the support body 61 and the driving portion 636 are engaged with each other, and a working position in which the engagement is released. The connection locking mechanism further includes a retaining assembly acting between the support body 61 and the driving portion 636, and the retaining assembly is used to limit the driving portion 636 in the locked position.

[0363] The support cylinder is partially radially extended to form an outer protrusion, and the driving portion 636 is arranged outside the outer protrusion and is linked with the gear 635. The connection locking mechanism acts between the driving portion 636 and the outer protrusion. The driving portion 636 is a hollow knob as a whole, and is covered on the outer protrusion.

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

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

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

[0367] The driving portion 636 is slidably connected to the support body 61 to switch between the locked position and the working position. The gear 635 is fixedly connected with the driving portion 636, and during the switching of the driving portion 636, the gear 635 always maintains engagement with the gear rack 634.

[0368] The rotation axis of the driving portion 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 portion 636 during the switching of the driving portion 636 is consistent with the direction of the rotation axis of the driving portion 636.

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

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

[0371] The insertion hole 6378 is provided on the rack 634 and when it is aligned with the locking pin 6377 , it locks the rack 634 and the support body 61 .

[0372] When the locking pin 6377 is engaged with the socket 6378, the relative positions of the rack 634 and the support body 61 are determined in the axial direction of the support body 61, thereby realizing the function of the connection locking mechanism 637. Similar to the clamping column 6374 mentioned above, a corresponding retaining assembly 6373 can also be provided here. The retaining assembly 6373 here can use a self-clamping clamping member to achieve the clamping of the locking pin 6377. The specific structure can be seen in the attached Figure 7f As shown, those skilled in the art can clearly understand it and will not be described again here.

[0373] In addition to the threaded and rack-and-pinion couplings mentioned above, in one embodiment, at least one of the controlled components extends beyond the proximal end of the control handle 60 to achieve direct transmission. The advantage of direct transmission is that it facilitates movement of the controlled component, particularly when motion accuracy is low. By placing the direct transmission at the proximal end of the control handle 60, this embodiment fully utilizes the axial space on the proximal end of the control handle 60 and the structural characteristics of the axial arrangement of the controlled component.

[0374] When the controlled component is a plurality of pipes, the innermost pipe can extend out of the proximal side of the control handle 60 to realize direct transmission. Of course, in order to maintain the predetermined position, a positioning mechanism 65 can be set at the proximal end of the handle and serve as a connecting component for direct transmission. The positioning mechanism can lock or release the controlled component, and the controlled component after release adopts direct transmission.

[0375] In other embodiments, a control handle 60 is disclosed, having opposing distal and proximal ends, for driving five controlled components (hereinafter taking five tubes disposed inside and outside as an example) to move relative to each other. The control handle includes a support body and a plurality of connection assemblies mounted on the support body. Each connection assembly includes five connection assemblies arranged sequentially from the distal end to the proximal end, and sequentially adopts threaded transmission, fixed arrangement, threaded transmission, rack and pinion transmission, and direct transmission.

[0376] The controlled components include an outer sheath, an inner sheath, a bending adjuster, a pull wire and an inner core, and the proximal ends of the five are sequentially linked to the five sets of connection components in the control handle.

[0377] The outer sheath tube, the inner sheath tube, the bending adjusting member, the pull wire (the proximal end is the wire control tube 20) and the inner core are arranged from outside to inside in the controlled component, and are sequentially adopted with threaded transmission, fixed setting, threaded transmission, gear and rack transmission and direct transmission,

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

[0379] The outer sheath tube 50 is slidably sleeved outside the bending adjusting 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 part 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 is an extension segment 11 extending out of the distal end of the inner sheath tube 30, the extension segment 11 is provided with a lock piece 13 matched with the lock 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 lock piece 13 is 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 channel to the control handle, so as to control the release process of the interventional instrument 90, that is, the interventional instrument 90 is slidably arranged between the inner sheath tube 30 and the inner core 10;

[0383] The bending adjusting member 40 is arranged inside the inner sheath tube 30, the distal end parts of the bending adjusting member 40 and the inner sheath tube 30 are fixed with each other, and the proximal end is slidably matched to realize the bending adjustment of the inner sheath tube 30 on the distal end side;

[0384] The outer sheath tube 50 is slidably sleeved outside the bending adjusting member 40, the outer sheath tube 50 moves relative to the inner core 10 to release the interventional instrument 90, and 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 pipe members are arranged as follows:

[0386] The inner core 10 adopts a direct transmission mode, and the proximal end side extends to the axial end face of the proximal end side of the control handle 60;

[0387] The wire control tube 20 adopts gear and rack cooperation, and the proximal end side extends to the proximal end side of the control handle 60;

[0388] The inner sheath tube 30 is fixedly connected with the control handle 60, and serves as a reference for the movement of the pipe members;

[0389] The bending adjusting member 40 and the outer sheath tube 50 respectively adopt threaded driving modes, and the proximal ends extend to the distal end side of the control handle 60.

[0390] The connection mode of the inner sheath tube 30 and the bending adjusting member 40 can be interchangeable, and the adaptability is adjusted according to the different sleeve setting relationship.

[0391] The inner core 10 is arranged in the control handle 60 from the distal end to the proximal end, and the proximal end of the control handle is in sealing fit with the outer peripheral surface of the inner core 10. Figure 7a In the disclosed embodiment, the number of pipe fittings can be further increased by increasing the number of connection assemblies, and the integration degree is improved.

[0392] The specific structure in the control handle 60 is disclosed, and the connection relationship of each pipe fitting is exemplarily described. Figure 6b The specific structure in the control handle 60 is disclosed, and the connection relationship of each pipe fitting is exemplarily described.

[0393] The inner core 10 is arranged in the control handle 60 from the distal end to the proximal end, and the proximal end of the control handle is in sealing fit with the outer peripheral surface of the inner core 10.

[0394] The wire control pipe 20 is sleeved on the outer peripheral surface of the inner core 10 and extends to the proximal end of the control handle 60, and is connected with the proximal end of the control handle 60 in the form of gear and rack cooperation.

[0395] The bending adjusting member 40 is arranged on the outer peripheral surface of the wire control pipe 20 and extends to the position near the middle part of the proximal end of the control handle 60, and is connected with the control handle 60 in the form of thread cooperation.

[0396] The inner sheath tube 30 is sleeved on the outer peripheral surface of the bending adjusting member 40 and extends to the position of the middle part of the proximal end of the control handle 60, and is connected with the control handle 60 in the form of fixed connection.

[0397] The outer sheath tube 50 is sleeved on the outer peripheral surface of the inner sheath tube 30 and extends to the position of the distal end of the proximal end of the control handle 60, and is connected with the control handle 60 in the form of thread cooperation.

[0398] In the above connection mode, the distal end portions of the bending member 40 and the inner sheath tube 30 are fixed to each other, when the proximal end side of one of them receives a force, the distal end of both will have a bending trend, thus generating the overall bending of the distal end of the delivery assembly. In product design, the form that the inner tube actively generates driving force to drive the outer tube to bend together is called inner bending, and the form that the outer tube actively generates driving force to drive the inner tube to bend together is called outer bending. In actual implementation process, both forms have their own advantages. In this application, the tube that actively moves is defined as the bending member 40, and the tube that passively assists the bending of the bending member 40 is defined as the inner sheath tube 30. Because the distal end sides of both are fixed to each other, the overall performance of both is stronger in the drawings. In this embodiment, the bending form is preferably inner bending.

[0399] The Figure 7c The disclosed control handle 60 embodiment is the same as the above, the difference is that the gear connection assembly is provided with two sets, one set at the most proximal end can be used to drive the inner core 10 or other parts that need to move, the rest of the skilled in the art can clearly understand the connection relationship between each tube and each part in the control handle 60 according to the description of the present application, which will not be repeated 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. The control handle 60 is used to drive controlled components in the interventional instrument 90 delivery assembly to move relative to each other. The controlled components include:

[0401] The outer sheath tube 50;

[0402] The inner sheath tube 30 is slidably arranged inside the outer sheath tube. The outer sheath tube moves relative to the inner sheath tube to release the interventional instrument. The distal end portion of the inner sheath tube 30 is fixed with a lock seat 31;

[0403] The inner core 10 is slidably arranged in the inner sheath tube 30. One end of the inner core 10 is an extension segment 11 that extends out of the distal end of the inner sheath tube 30. The extension segment 11 is provided with a lock piece 13 that cooperates with the lock 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. The lock piece 13 is used to restrict the movement state of the pull wire 21;

[0404] The pull wire extends from the lead-through channel to the control handle to control the release process of the interventional instrument, by itself or through a wire control tube fixed to the pull wire;

[0405] In the loaded state, the pull wire 21 extends out of the distal end of the inner sheath tube 30, passes through the interventional instrument 90 and is bound to the lock piece 13. The lock piece 13 is inserted and cooperated with the lock seat 31 to limit the pull wire 21 from being unbound.

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

[0407] When the interventional instrument 90 is delivered to the vicinity of the target point, refer to the accompanying drawings Figure 9a to the accompanying drawings Figure 9b By retracting 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 accident occurs, the interventional instrument 90 can be recovered by advancing the outer sheath tube 50.

[0408] When the outer sheath tube 50 is retracted, refer to the accompanying drawings Figure 9b The interventional instrument 90 has been completely released from the outer sheath tube 50, but the proximal end is still constrained by the pull wire 21. At this time, if an accident occurs, the operator can still recover the interventional instrument 90 by driving the pull wire 21 through the wire-controlled tube 20.

[0409] When the interventional instrument 90 is released smoothly, refer to the accompanying drawings Figure 9c By adjusting the relative movement of the inner sheath tube 30 and the core tube, the lock 13 is separated from the lock hole 311, and the pull wire 21 is released. At this time, the interventional instrument 90 is separated from the delivery assembly, the delivery assembly is retracted, and the interventional process is completed.

[0410] The application further discloses an interventional system, which comprises an interventional instrument and a delivery assembly. The interventional instrument comprises: an annular part 71, which is a radially deformable structure, and has a first end 711 and a second end 712 at two ends in the axial direction of the annular part 71; wherein the edge of the first end 711 comprises a plurality of unit segments 713 arranged in sequence in the circumferential direction of the annular part 71;

[0411] a plurality of guide parts 72, which are arranged in sequence and at intervals in the circumferential direction of the annular part 71, and are connected to corresponding unit segments 713 on one side; and the other side of each guide part 72 gradually converges to a terminal end 721, and has a threading ring 722 at the terminal end 721;

[0412] The delivery assembly comprises:

[0413] an inner sheath tube, which has opposite distal and proximal ends;

[0414] a lock seat, which is connected to the distal end of the inner sheath tube;

[0415] The inner core is slidably arranged in the inner sheath tube, one end of the inner core is an extension section extending out of a distal end of the inner sheath tube, and a radial gap between the inner core and the inner sheath tube is a threading channel;

[0416] The locking piece is fixed to the extension section of the inner core and is located on the distal end side of the lock seat.

[0417] The pull wire is movably arranged in the threading channel, in the loaded state of the interventional instrument, the pull wire extends out of the distal end of the inner sheath tube, is bound to the locking piece after passing through the threading ring 722 of the interventional instrument, and the locking piece is inserted and matched with the lock seat to limit the pull wire from being unbound.

[0418] In another embodiment, the application further provides another control handle, as shown in Figure 7h~Figure 7j The handle includes a support body 61 and a plurality of sets of connection assemblies mounted on the support body 61, and each connection assembly is fixedly arranged or movably arranged relative to the support body 61. The connection assemblies movably arranged include threaded transmission, gear and rack transmission, and direct transmission, and the connection assemblies of each transmission mode are arranged in sequence from the distal end to the proximal end.

[0419] The controlled components can all be tubes and are nested with each other, or can not be in the form of tubes and only extend to the control handle in the proximal direction. The controlled components can all be movable relative to the control handle, or one or more of them can be fixedly arranged relative to the control handle.

[0420] Each of the threaded transmission, the gear and rack transmission, and the direct transmission has its own advantages. The arrangement of the control handle 60 from the distal end to the proximal end can meet the different movement requirements of each tube and realize structural optimization of the space structure of the control handle 60, 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.

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

[0422] The thread cooperation and the gear rack cooperation have the characteristics of providing stable transmission ratio, especially in the case that the controlled part needs accurate control. The thread cooperation has the advantage of realizing rotation in the circumferential direction of the control handle 60, thereby saving the circumferential space of the handle, but has certain requirements for the axial space; correspondingly, the gear rack cooperation has the advantage of saving the axial space of the handle, but has certain requirements for the circumferential space. 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.

[0423] In the embodiment, the thread cooperation area 62 is provided with a set of threaded connection assemblies 621, which include: a driving ring 622 rotatably sleeved on the outer circumference 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 part, i.e. the outer sheath 50, and the outer circumference of the clamping piece 625 is in threaded cooperation with the inner circumferential surface of the driving ring 622.

[0424] The clamping piece 625 has 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, and of course, adhesion or fasteners can also be used 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 part 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 part, and is preferably in sealed butt joint with the pipe when the controlled part is a pipe.

[0426] Each controlled part needs to be positioned after moving to the appropriate position to avoid being affected by other operations. In an embodiment, a positioning ring 623 is slidably sleeved on the outer circumference of the support body 61, and the driving ring 622 has a positioning state of being clamped with the positioning ring 623 and a free state of being separated from each other; in the positioning state, the positioning ring 623 limits the rotation of the driving ring 622.

[0427] The positioning ring 623 can be arranged to be slidably installed on the support body 61, and can realize positioning or releasing 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 setting 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 set as an interference fit to ensure the friction therebetween, avoid the constraint force of the positioning ring 623 on the driving ring 622 invalidation or cause accidental locking to affect the operating personnel to perform the treatment process.

[0429] Reference 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 setting is that it can reduce the influence on the movement process of the driving ring 622 while realizing the function of the positioning ring 623, and at the same time optimize the layout of each component on the control handle 60.

[0430] Reference Figure 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 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 operating personnel, 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 by the operating personnel, and the two cooperate with each other to further improve the operation experience.

[0431] In a specific component of the gear connecting assembly 631, in 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 end side. The gear connecting assembly 631 comprises:

[0432] The rack 634 moving 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 the gear 635 rotatingly installed 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 pipe 20 is inserted into the mounting hole and is clamped and fixed by the hole wall of the mounting hole, and of course, it can also cooperate with adhesives or fasteners to prevent loosening.

[0435] In this embodiment, the gear 635 serves as a driving component and can drive the rack 634 to move to realize the driving of the controlled component. At least a part of the gear 635 extends to the outside of the support body 61 or is provided with a corresponding structure extending to the outside of the support body 61. In order to facilitate operation and assembly, the outer circumferential space of the support body can also be fully utilized to improve the space utilization.

[0436] In actual structure, the rack 634 can also be provided with corresponding structure to improve the cooperation with the controlled components. Referring to an embodiment, the control handle 60 includes a support cylinder 638 sleeved on the proximal end of the support body 61, and the controlled components are connected with the gear in the following manner:

[0437] a base 632 slidingly installed inside the support cylinder 638, and the rack 634 is fixedly arranged on the base 632;

[0438] a clamping base 633 installed on the base 632 and used for connecting the proximal end of the wire control pipe 20.

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

[0440] The clamping base 633 can be fixedly installed on the base 632, and can also have slight axial movement allowance relative to the base 632, for example, a guiding structure (such as the slide rail 6321) matched with each other is arranged between the clamping base 633 and the base 632, guiding the axial movement of the clamping base 633 and limiting 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 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, facilitating the installation of the clamping base 633.

[0441] Similarly to 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 installed 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 the connecting locking mechanism 637 is arranged therebetween to limit the rotation of the driving part 636.

[0442] Referring to Figure 7j~Figure 7o , the support cylinder 638 is partially radially extended to form an outer convex part 6382, and the driving part 636 is arranged outside the outer convex part 6382 and linked with the gear 635. The driving part 636 is a hollow knob as a whole, and is covered on the outer convex part 6382. The connecting locking mechanism 637 includes:

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

[0444] The second locking tooth 6372 cooperates with the first locking tooth 6371 and is arranged on the outer protrusion 6382.

[0445] The retaining assembly 6373 maintains the engagement of the first locking tooth 6371 and the second locking tooth 6372 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 the gear 635 relative to the support cylinder 638 to realize the engagement or disengagement of the first locking tooth 6371 and the second locking 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 positions is consistent with the direction of the rotation axis of the driving part 636. The gear 635 maintains the engagement with the rack 634 at all times during the sliding process, and thus, in a certain sense, the gear 635 is always engaged with the rack 634 within the sliding stroke of the gear 635. The realization means includes, for example, that the engagement width of the rack 634 is greater than the engagement width of the gear 635.

[0447] In an embodiment, the retaining assembly 6373 ensures 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 are slidingly installed on the driving part 636 and approach or move away from each other in the radial direction of the gear 635.

[0449] A clamping block 6381 is arranged on the outer protrusion 6382.

[0450] A 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 of the end faces of the clamping block 6381, thereby maintaining the connection locking mechanism 637 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, thereby realizing the state switching of the connection locking mechanism 637.

[0452] The retaining 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 rotation axis 6351 connected with the driving part 636. The support cylinder 638 is fixedly arranged with a limiting seat 6383 sleeved outside the rotation axis 6351. The limiting seat 6383 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 one embodiment, the catheter assembly further comprises a sheath tube 51 sleeved on the outer periphery of 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 mounted with a first fixed seat 611 fixedly connected with the inner sheath tube 30, and the first fixed seat 611 is between the clamping member 625 and the clamping base 633 in the axial direction of the support body. The proximal end of the support body 61 is slidingly mounted with a sliding seat 612 fixedly connected with the inner core 10.

[0456] The control handle 60 is provided with an exhaust assembly 64 and serves as a fixedly arranged connecting assembly, and the proximal end of the corresponding controlled component is communicated 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 each tube by a single exhaust assembly through the opening of the tube wall and the relative movement can also be achieved. The form of sharing an exhaust assembly 64 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.

[0459] The technical features of the above embodiments can be combined in any way. In order to make the description simple, all possible combinations of the technical features in the above embodiments are not described, but as long as the combination of the technical features does not exist contradictory, it should be considered as the scope disclosed in the specification. When the technical features in different embodiments are embodied in the same figure, it can be considered that the figure also discloses the combination of each embodiment involved.

[0460] The above embodiments only express several implementation manners of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the patent application scope. It should be noted that for ordinary skilled persons in the art, without departing from the concept of the present application, several modifications and improvements can be made, which are within the protection scope of the present application.

Claims

1. An artificial heart valve device, characterized in that: The invention comprises a stent and leaflets located within the stent. The stent is generally a tubular structure and has a relatively compressed state and an expanded state. The interior of the stent is a blood flow channel. The leaflets cooperate with each other in the blood flow channel to relatively open or close the blood flow channel. The inner side of the stent is provided with an inner covering film, and an anti-circumferential leakage component is fixed to the outer side of the inner covering film. The anti-circumferential leakage component is in the form of blocks distributed at intervals and positioned corresponding to the hollowed-out areas of the tubular structure. In the expanded state, the anti-circumferential leakage component protrudes from the outer peripheral surface of the stent; The tubular structure has a multi-channel cell structure, and the anti-circular leakage component is arranged as follows: Mode A, the anti-circular leakage component includes: A first circle of anti-circumferential leakage components is disposed close to the inflow side of the bracket, and the first circle of anti-circumferential leakage components is circumferentially distributed throughout the cells in which they are located; a second ring of anti-circular leakage components, adjacent to the inflow side of the first ring of anti-circular leakage components; Or in mode B, the anti-circular leakage component includes: A first circle of anti-circumferential leakage components is provided on the inflow side of the bracket, and the first circle of anti-circumferential leakage components fully covers the cells in which they are located; a third ring of anti-circular leakage components, adjacent to the outflow side of the first ring of anti-circular leakage components; Or in mode C, the anti-circular leakage component includes: A first circle of anti-circumferential leakage components is provided on the inflow side of the bracket, and the first circle of anti-circumferential leakage components fully covers the cells in which they are located; a second ring of anti-circular leakage components, adjacent to the inflow side of the first ring of anti-circular leakage components; a third ring of anti-circular leakage components, adjacent to the outflow side of the first ring of anti-circular leakage components; The axial length of the second circle of anti-circumferential leakage components is half the length of a cell, and the axial length of the third circle of anti-circumferential leakage components is half the length of a cell.

2. The artificial heart valve device according to claim 1, wherein: The anti-circumferential leakage component is made of porous material.

3. The artificial heart valve device according to claim 1, wherein: The anti-circumferential leakage component and the inner covering film are an integrated structure; The tubular structure has a cell structure with multiple channels, and the anti-leakage component is in contact with the side edge of the rod of the cell in which it is located.

4. The artificial heart valve device according to claim 1, wherein: In the same anti-circumferential leakage component, the thickness gradually increases from the outflow side to the inflow side, and then gradually becomes thinner after reaching the highest convex part; In the axial direction of the tubular structure, the portion with the largest convex height is closer to the inflow side.

5. The artificial heart valve device according to claim 1, wherein: In the axial direction of the tubular structure, the distance between the part with the largest convex height of the anti-leakage component and the inflow side of the cell is S1, and the distance between the part with the largest convex height and the inflow side of the cell is S2, wherein the ratio of S1:S2 ranges from 0.2 to 0.8:

1.

6. The artificial heart valve device according to claim 1, wherein: The inner film is a biocompatible biological film or PET material.

7. The artificial heart valve device according to claim 1, wherein: The bracket comprises: An annular portion, wherein the annular portion is a radially deformable structure, wherein the two ends of the annular portion in its own axial direction are respectively a first end and a second end, wherein the edge of the first end includes a plurality of unit segments arranged sequentially along the circumference of the annular portion; The plurality of guide portions are sequentially spaced along the circumference of the annular portion, one side of each guide portion is connected to a corresponding unit segment, and the shape of the other side of each guide portion gradually converges to the end.

8. The artificial heart valve device according to claim 7, wherein: The peripheral leakage prevention components are arranged in one or more rows along the circumferential direction of the inflow end of the annular portion.

9. The artificial heart valve device according to claim 7, wherein: The inner covering is located on the inflow side of the leaflet and docks with the fixed edge of each leaflet. The inner covering extends from the fixed edge of the leaflet to the second end of the annular portion.

10. The artificial heart valve device according to claim 7, wherein: The anti-circumferential leakage component is fixed on the outside of the inner covering film. The anti-circumferential leakage component is in the shape of blocks distributed at intervals and its position corresponds to the hollow area of ​​the tubular structure.

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