Control mechanism, locking mechanism and pre-assembly method for artificial implants

Abstract

The application discloses a control mechanism, a locking mechanism and a loading method and a preloading method of an artificial implant. The control mechanism of the artificial implant comprises a base, a pull wire and a lock piece, wherein the base is provided with a lock hole; the pull wire has a free end which can be wound around or separated from the artificial implant; and the lock piece is rotationally matched with the base to lock the free end of the pull wire. After optimization of the control mechanism, the control mechanism and the artificial implant can be matched with each other to realize the control of the expansion, release or recovery process of the artificial implant in the body, and the control mechanism is more suitable for working in the body than the existing structure.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a control mechanism of an artificial implant, a locking mechanism and a pre-assembly method. BACKGROUND

[0002] With the development of medical conditions, artificial implants have been used to treat heart valve disorders, and common treatment methods generally include repairing or replacing the valve through surgery, or using a flexible catheter to intervene and implant an artificial implant.

[0003] In the intervention technology, the artificial implant in the compressed and loaded state is installed at the distal end of the catheter assembly and is delivered to the predetermined site, and the catheter assembly is removed from the body after the artificial implant is radially expanded and released.

[0004] For the connection of the artificial implant and the catheter assembly, the existing technology can adopt direct clamping or wire control mode, that is, the flexible member is used to bind the artificial implant to the distal end of the catheter assembly, and the flexible member is locked to maintain the compressed state of the artificial implant. When it is necessary to release the artificial implant, the locking of the flexible member is released, and the flexible member is then loosened until it is separated from the artificial implant to complete the release of the artificial implant, but the control mode and control structure of the flexible member in the existing technology still need to be improved. SUMMARY

[0005] In order to better play the characteristics of the wire control mode and further improve the flexibility of the control structure and operation, the present application provides a control mechanism of an artificial implant, comprising:

[0006] a base provided with a locking hole;

[0007] a pull wire having a free end capable of being wound around or separated from the artificial implant;

[0008] a locking member in rotational cooperation with the base, the locking member entering or moving out of the locking hole during rotation to lock or release the free end of the pull wire.

[0009] Optionally, the free end of the pull wire has a first state limited to the base and a second state in which the limitation is released, the free end has a ring, and one part of the locking member is a positioning portion having a spiral structure.

[0010] When the free end is in the first state, the positioning portion penetrates the ring, and when the free end is in the second state, the positioning portion is extracted from the ring.

[0011] Optionally, the locking member is located at the distal end of the base as a whole.

[0012] Optionally, the base is provided with a plurality of locking holes, and the plurality of locking holes are arranged along a spiral line.

[0013] Optionally, the base comprises an outer sleeve and an inner core sleeve which are fixedly nested, and the locking holes are arranged between the outer sleeve and the inner core sleeve in a radial direction.

[0014] Optionally, the base has a first cavity inside, and the inner core sleeve is of an axial through structure to provide the first cavity.

[0015] The proximal end side of the base has a first opening which is in communication with the first cavity, the outer peripheral surface of the base has a second opening which is in communication with the first cavity, the base is provided with a plurality of locking holes, and the plurality of locking holes are arranged along a spiral line, the spiral line intersects the second opening, and all the locking holes are directly or indirectly in communication with each other through the second opening.

[0016] Optionally, the inner wall of the outer sleeve and / or the outer wall of the inner core sleeve is provided with a spiral groove for providing the locking holes, and the spiral groove intersects the second opening.

[0017] The application also provides a locking mechanism for connecting an artificial implant with a delivery system, comprising:

[0018] a first shaft, a loading section is fixed at the distal end of the first shaft, the loading section is open towards the proximal end, and is used for accommodating a distal end part of the artificial implant;

[0019] a pull wire, having a free end which can be threaded around or detached from the artificial implant;

[0020] a third shaft, which is slidingly sleeved outside the first shaft;

[0021] a locking assembly, the artificial implant is bound to the locking assembly by the pull wire when loaded, and the locking assembly comprises a locking piece and a base which is fixed to the third shaft, and the locking piece and the base have:

[0022] a mutual cooperation locking state, which limits the pull wire from being detached from the artificial implant;

[0023] a mutual cooperation unlocking state, which allows the pull wire to be detached from the artificial implant;

[0024] a linkage assembly, which acts between the first shaft and the locking piece to selectively link them;

[0025] In the unlocking state, the locking piece can be rotated outside the peripheral surface of the first shaft, and in the locking state, the locking piece is linked with the first shaft and rotates with the first shaft until it is combined with the base and binds the pull wire.

[0026] Optionally, the linkage assembly comprises two matching parts, one of which is connected to the loading segment, and the other of which is connected to the lock piece, and axial movement of the loading segment can make the two matching parts link or unlink;

[0027] The two matching parts are an axially slidable linkage key and a linkage slot, and the linkage key rotates in linkage with each other when inserted into the linkage slot.

[0028] The application also provides a wire control type artificial implant preloading method, comprising:

[0029] The control mechanism described in the application is provided, in which the free end of the pull wire passes through the proximal end of the artificial implant;

[0030] The free end of the pull wire has a wire ring and two support points, and the installation segment is placed between the two support points, so that the wire ring is placed around the movement path of the lock piece;

[0031] Driving the lock piece to rotate and move along its own movement path through the wire ring and then inserting it into the lock hole of the base to bind the free end.

[0032] The control mechanism of the application can achieve in-vivo expansion, release or recovery of the artificial implant, and the control of the pull wire is smoother. BRIEF DESCRIPTION OF DRAWINGS

[0033] Figure 1a A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant;

[0034] Figure 1b A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant; Figure 1a A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant;

[0035] Figure 2a A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant;

[0036] Figure 2b A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant; Figure 2a A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant;

[0037] Figure 3 A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant;

[0038] Figure 4 A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant;

[0039] Figure 5 A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant;

[0040] A schematic diagram of a control mechanism of an embodiment of the application limiting an artificial implant;Figures 6a to 6c They are schematic diagrams of the gradually retracting wire control end of the artificial implant of the present application;

[0041] Figure 7a 、 Figure 7b They are schematic diagrams of the artificial implant of the present application during threading and folding respectively;

[0042] Figure 8 A schematic diagram of the structure of a pull-wire-restricted artificial implant in an existing control mechanism;

[0043] Figure 9 for Figure 8 Schematic diagram of the structure in which the middle pull wire is separated from the base to release the restraint on the artificial implant;

[0044] Figure 10 This is a schematic structural diagram of a conveying system according to an embodiment of the present application;

[0045] Figure 11 for Figure 10 Enlarged view of part A in the middle;

[0046] Figure 12 This is a schematic diagram of the coordination between the base, the lock element, and the pull wire according to an embodiment of the present application;

[0047] Figure 13a for Figure 12 Exploded view of the center lock, base, and cable;

[0048] Figure 13b for Figure 13a Partial structural view of the distal end of the second axis;

[0049] Figure 14 for Figure 10 Left side view of the conveying system;

[0050] Figure 15 for Figure 14 Partial cross-sectional view at the base in the middle BB direction;

[0051] Figure 16a This is a schematic structural diagram of a pull wire at a free end according to an embodiment of the present application;

[0052] Figure 16b This is a schematic structural diagram of a pull wire at a free end according to another embodiment of the present application;

[0053] Figure 17 This is a schematic structural diagram of a base according to an embodiment of the present application;

[0054] Figures 18a to 19 They are schematic diagrams of the lock element passing through each pull wire in sequence in the control mechanism of the present application;

[0055] Figure 20aThis is a structural schematic diagram of a pull wire in a first state according to an embodiment of the present application;

[0056] Figure 20b This is a structural schematic diagram of a pull wire in a second state according to an embodiment of the present application;

[0057] Figures 21a to 21c They are schematic structural diagrams of a pull wire and each locking element combined in sequence according to an embodiment;

[0058] Figure 22 This is a front view of a base according to an embodiment of the present application;

[0059] Figure 23a This is a structural view of a positioning portion of a lock element according to an embodiment of the present application;

[0060] Figure 23b This is a structural view of a positioning portion of a lock element according to another embodiment of the present application;

[0061] Figure 24a This is a diagram of the matching structure of the lock and the base according to an embodiment of the present application;

[0062] Figure 24b for Figure 24a Structural view of the middle lock;

[0063] Figure 24c for Figure 24a Structural view of the middle locking parts after they are relatively separated;

[0064] Figure 25a This is a structural diagram of the lock and the base in another embodiment of the present application;

[0065] Figure 25b for Figure 25a Exploded view of;

[0066] Figure 26 A schematic diagram of threading an artificial implant in the prior art;

[0067] Figure 27a A roadmap for the convergence of existing artificial implants;

[0068] Figure 27b A schematic diagram of a conventional artificial implant after folding;

[0069] Figure 28 A folding roadmap for the artificial implant of this application;

[0070] Figure 29 This is a front view of a control mechanism according to an embodiment of the present application, wherein a pull wire pulls the proximal end of an artificial implant radially inwardly;

[0071] Figure 30aStructure view of the control mechanism in one embodiment of the present application with the loading segment retracted and the lock engaged;

[0072] Figure 30b Structure view of the control mechanism in one embodiment of the present application with the loading segment retracted and the lock engaged; Figure 30a Front view of the control mechanism in one embodiment of the present application (pull wires removed for ease of viewing);

[0073] Figure 31 Half-section view of the control mechanism in one embodiment of the present application with the loading segment and the lock engaged;

[0074] Figure 32 Structure view of the control mechanism in one embodiment of the present application with the loading segment retracted and the lock engaged;

[0075] Figure 33 Structure view of the control mechanism in one embodiment of the present application with the loading segment retracted and the lock engaged; Figure 32 Exploded view of the loading segment in one embodiment of the present application;

[0076] Figure 34a Exploded view of the support in one embodiment of the present application; Figure 33 Exploded view of the support in one embodiment of the present application;

[0077] Figure 34b Half-section view of the support in one embodiment of the present application;

[0078] Figure 35 Section view of the control mechanism in one embodiment of the present application with the loading segment retracted and the lock engaged;

[0079] Figure 36a Partial structure view of the control mechanism in one embodiment of the present application with the loading segment loading an artificial implant;

[0080] Figure 36b Radial relationship view of the control mechanism in one embodiment of the present application with the loading segment and the arm of an artificial implant;

[0081] Figure 36c Radial relationship view of the control mechanism in one embodiment of the present application with the loading segment, the artificial implant and the catheter sheath;

[0082] Figure 37 Structure view of an artificial implant in one embodiment of the present application (leaflet, skirt, etc. structures omitted in the figure);

[0083] Figure 38 Front view of an artificial implant in one embodiment of the present application (leaflet, skirt, etc. structures omitted in the figure);

[0084] Figure 39 Structure view of a delivery system in one embodiment of the present application;

[0085] Figure 40 Structure view of a catheter sheath in one embodiment of the present application;

[0086] Figure 41aThis is a schematic diagram of the structure of a control mechanism wrapping and restraining an artificial implant according to an embodiment of the present application;

[0087] Figure 41b This is a schematic diagram of the structure of the control mechanism in one embodiment of the present application for driving the catheter sheath to release the restraint on the arm;

[0088] Figures 41c to 41e This is a schematic diagram of releasing the pull wire in the control mechanism of the present application to gradually expand the proximal end of the artificial implant;

[0089] Figure 41f This is a structural diagram of the two cooperating parts in the control mechanism of the present application cooperating with each other and releasing the pull wire;

[0090] Figure 41g A schematic diagram of the control mechanism of this application exiting the body;

[0091] Figure 42 This is a schematic structural diagram of a control handle according to an embodiment of the present application;

[0092] Figure 43 for Figure 42 Exploded view of the ejector mechanism;

[0093] Figure 44 for Figure 42 Schematic diagram of the structure in which the first stage of the middle telescopic assembly is extended and abuts against the fixed seat;

[0094] Figure 45 for Figure 44 A schematic diagram of the structure of the middle push-up drive mechanism driving the telescopic assembly to move toward the distal end;

[0095] Figure 46 This is a structural diagram of a control handle according to an embodiment of the present application;

[0096] Figure 47 for Figure 46 Exploded view of;

[0097] Figure 48 This is a schematic structural diagram of the base in the control mechanism of this application;

[0098] Figure 49 A half-section schematic diagram of the base portion of the control mechanism of the present application;

[0099] Figure 50a 、 Figure 50b A three-dimensional schematic diagram of the lock element in the control mechanism of the present application being inserted into and removed from the lock hole;

[0100] Figure 51 This is a schematic diagram of the structure of the lock and the base in the control mechanism of this application;

[0101] Figure 52aFig. 1 is a schematic view of the process of inserting the lock into the lock hole of the control mechanism of the present application;

[0102] Figure 52b Fig. 2 is a schematic view of the partial structure of the base of the control mechanism of the present application;

[0103] Figure 53 Fig. 3 is a schematic view of the half-section of the pull wire control end of the base of the control mechanism of the present application;

[0104] Figure 54a 、 Figure 54b Fig. 4 is a schematic view of the structure of the lock of the control mechanism of the present application;

[0105] Figure 55 Fig. 5 is a schematic view of the path of the pull wire through the lock of the control mechanism of the present application;

[0106] Figure 56a 、 Figure 56b Fig. 6 is a schematic view of the linkage of the control mechanism of an embodiment of the present application;

[0107] Figure 57a 、 Figure 57b Fig. 7 is a schematic view of the linkage of the control mechanism of another embodiment of the present application;

[0108] Figure 58 Fig. 8 is a schematic view of the structure of the connecting portion of the lock of the control mechanism of the present application;

[0109] Figure 59 Fig. 9 is a schematic view of the partial structure of the distal end of the first shaft of the control mechanism of the present application;

[0110] Figures 60a to 60b Fig. 10 is a schematic view of the half-section of the separation and combination of the first shaft and the connecting portion of the control mechanism of the present application;

[0111] Figure 61 Fig. 11 is a schematic view of the rotation of the first shaft and the connecting portion of the control mechanism of the present application after combination;

[0112] Figure 62 Fig. 12 is a schematic view of the cross-section of the base of the control mechanism of the present application;

[0113] Figure 63 Fig. 13 is a schematic view of the structure of the control mechanism (lock combined with pull wire) of an embodiment of the present application;

[0114] Figure 64 Fig. 14 is a schematic view of the structure of the control mechanism (lock combined with pull wire) of another embodiment of the present application; Figure 63 Fig. 15 is a schematic view of the structure of the control mechanism (lock combined with pull wire) of another embodiment of the present application;

[0115] Figure 65 Fig. 16 is a schematic view of the assembly of the lock, base, and pull wire of an embodiment of the present application;

[0116] Figure 66Structure diagram of the delivery system of an embodiment of the present application;

[0117] Figure 67 Structure diagram of the delivery system of an embodiment of the present application; Figure 66 Enlarged view of A portion in the middle;

[0118] Figure 68 Structure diagram of the delivery system of an embodiment of the present application; Figure 67 Partial diagram after removal of the artificial implant;

[0119] Figure 69 Structure diagram of the delivery system of an embodiment of the present application; Figure 68 Enlarged diagram of C portion after combination with the pull wire;

[0120] Figure 70 Explosion diagram of the lock and the base of an embodiment of the present application;

[0121] Figure 71 Front view of the lock and the base of an embodiment of the present application;

[0122] Figure 72 Structure diagram of the delivery system of an embodiment of the present application; Figure 71 Partial sectional view in E-E direction;

[0123] Figure 73 Structure diagram of the delivery system of an embodiment of the present application; Figure 72 Enlarged view of F portion in the middle;

[0124] Figure 74 Structure diagram of the delivery system of an embodiment of the present application; Figure 72 Sectional view in D-D direction;

[0125] Figure 75 Structure diagram of the delivery system of an embodiment of the present application; Figure 70 Structure diagram of the outer sleeve;

[0126] Figure 76 Structure diagram of the delivery system of an embodiment of the present application; Figure 70 Structure diagram of the inner core barrel;

[0127] Figure 77 Structure diagram of the delivery system of an embodiment of the present application; Figure 76 Front view of the inner core barrel;

[0128] Figure 78 Structure diagram of the delivery system of an embodiment of the present application; Figure 77 Sectional view of the inner core barrel in G-G direction;

[0129] Figure 79 Structure diagram of the base of another embodiment of the present application;

[0130] Figure 80 Structure diagram of the base of another embodiment of the present application;

[0131] Figure 81 Structure diagram of the delivery system of an embodiment of the present application; Figure 82 Structure diagram of the lock after combination with the pull wire and sequentially passing through the lock hole;

[0132] Figure 83 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application;

[0133] Figure 84 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application; Figure 83 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application;

[0134] Figure 85 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application; Figure 83 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application;

[0135] Figure 86 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application;

[0136] Figure 87 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application; Figure 86 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application;

[0137] Figure 88 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application;

[0138] Figure 89 Structure diagram of the lock and the inner core barrel in the initial stage of assembly (the outer barrel is removed for easy observation) of an embodiment of the present application;

[0139] 10, base; 101, locking area; 101a, locking area; 102, rib; 102a, rib; 102b, rib; 1021, bent section; 1022, avoiding area; 103, first cavity; 1031, first opening; 1033, second opening; 1034, side wall; 1035, rib; 1035a, rib; 1035b, rib; 1037, bent section; 1039, guide slot; 104, first opening; 105, lock hole; 105a, lock hole; 105b, lock hole; 105c, lock hole; 105d, lock hole; 105e, lock hole; 105f, lock hole; 106, extension section; 107, ring structure; 108, second opening; 11, pull wire; 112, advancing section; 111, free end; 111a, free end; 111b, free end; 111c, free end; 113, control end; 114, returning section; 115a, ring; 116, intermediate section; 117, detour section; 118, support point; 119, mounting section; 13, lock piece; 131, positioning part; 1311, end; 13110, end; 1313, head end; 13130, head end; 1315b, first axial gap; 1315a, second axial gap; 1317, inner space; 134, connecting part; 1341, linkage key; 135, connecting part; 1351, connecting section; 1352, linkage key; 1353, avoiding area; 1354, closing structure; 1355, cutout; 170, outer sleeve; 171, second opening; 172, extension section; 173, connecting hole; 174, positioning block; 180, inner core sleeve; 181, first cavity; 182, helical slot; 183, notch; 184, positioning slot; 185, guide slope; 186, first opening;

[0140] 21, first shaft; 211, loading section; 2111, linkage slot; 212, support piece; 213, flared structure; 2130, outer sleeve; 2131, positioning sheet; 2140, inner sleeve; 2141, linkage slot; 2142, flared structure; 215, guide head; 216, loading part; 217, avoiding opening; 22, transmission part; 23, second shaft; 231, connecting hole; 232, notch; 233, connecting arm; 234, deformation hole; 24, interventional part; 241, first interventional part; 242, second interventional part; 25, third shaft; 27, extension tube; 271, fitting part;

[0141] 3, control handle; 301, distal end; 302, proximal end; 3100, first handle; 3200, second handle; 31, proximal end; 32, distal end; 3300, support body; 333, rigid strip; 334, guide channel; 350, driving sleeve; 351, first driving sleeve; 355, force applying component; 360, mounting seat; 38, telescopic assembly; 381, first stage; 382, intermediate stage; 383, last stage; 384, abutting member; 39, pushing driving mechanism;

[0142] 4, catheter assembly; 40, tube; 400, artificial implant; 430, bending adjusting sheath; 500, wire holding device; 51, tube body; 510, main body section; 520, deformation section; 522, fork arm; 60, artificial implant; 601, wire control end; 603, eyelet; 604, blood flow passage; 605, connecting ear; 61, inner frame; 63, arm; 632, outflow side; 631, inflow side; 70, catheter sheath; 7200, fixing seat. DETAILED DESCRIPTION

[0143] 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 some of the embodiments of the present application, but not 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 fall within the scope of protection of the present application.

[0144] 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 an intermediate 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 an intermediate assembly.

[0145] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0146] In the present application, the terms "first", "second", etc. are only for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise specifically limited.

[0147] The present specification describes an artificial implant and a delivery system for delivering the artificial implant into a subject, the delivery system comprising a control handle and a catheter assembly, wherein the control handle is connectable to and controls the catheter assembly for performing an interventional procedure, the catheter assembly comprises a plurality of controlled members, the distal ends of the controlled members cooperatively operate the artificial implant, for example, releasing, retrieving, locking position, adjusting spatial orientation, etc., each controlled member can be a hollow tube, a solid rod, a flexible wire, or a combination of multiple forms, and the controlled members are multiple, and at least two of them (for example, proximal end) can slide axially or rotate axially relative to each other. The force applying part (the part directly contacted by the user for operation) on the control handle for operating each controlled member can be directly fixed transmission or transmission by screw, gear and rack, etc.

[0148] In the following, many improvements on the control handle or local structure can be implemented in the same control handle without obvious technical conflicts, but it is not strictly limited to being implemented in the same control handle, and each embodiment can be implemented alone or appropriately combined for different number of controlled members and motion characteristics, or for a control handle with further simplified structure.

[0149] The application site and structure of the artificial implant are not strictly limited, and in some drawings or texts, a prosthetic heart valve is taken as an example. The prosthetic heart valve generally comprises a deformable stent and valve leaflets connected in the stent. The stent is generally cylindrical in shape, and the side wall is a hollow grid structure. Unless otherwise stated, the shape or size of the grid structure is not strictly limited. The inside of the stent is a blood flow passage. Multiple valve leaflets cooperatively control the opening and closing degree of the blood flow passage in the stent. In order to position in the body, positioning structures such as anchor spikes and arm parts can be provided on the outer periphery of the stent to interact with the surrounding native tissue. In order to prevent leakage, skirts or anti-leakage materials can be provided on the inner side and / or outer side of the stent.

[0150] The stent can be made of a material selected according to the expansion mode, such as a nickel-titanium alloy with shape memory for self-expansion in the body, or a stainless steel material for balloon expansion, etc. The stent itself can be formed by cutting a pipe or weaving a wire. The valve leaflets can be connected to the stent by sewing, bonding or one-piece mold forming.

[0151] Taking a self-expanding stent as an example, its expansion and retrieval can be controlled by a sheath tube wrapped around the outer periphery of the stent. By exposing the stent to different parts of the sheath tube, the corresponding control can be achieved. The control can also be achieved by using a pull wire, i.e. the pull wire passes through the structural gap (or wire hole structure) of the stent. By adjusting the tightness of the pull wire by the control handle, the expansion degree of the stent can be changed. When the pull wire is pulled away from the stent, the stent is allowed to be completely released. Of course, the control of the pull wire is also achieved by the controlled members in the catheter assembly.

[0152] The stent of the artificial implant generally has a connecting structure cooperating with the catheter assembly to define the position of each other, so as to prevent unnecessary position deviation during the delivery. The artificial implant is in a radially compressed state, i.e. a loading state, when being fed, and is in an expanded state after being released from the catheter assembly and radially expanded in the body. The shape of the artificial implant is understood as the expanded state unless otherwise specified, and the local deformation caused by the pressure of the surrounding tissue is not considered.

[0153] Due to the complexity of the structure in the body, the catheter assembly often needs to be bent. The corresponding bending member can be in the form of a tube or a wire. The distal end acts on the bent part, and the proximal end is operated by the control handle to adjust the bending amplitude or direction.

[0154] When used to indicate the direction, the proximal end in the text generally refers to the side close to the operator (e.g. a doctor), and the distal end refers to the opposite side. Along the intervention path, each component has a relative distal end and proximal end. In theory, when the catheter assembly is completely straightened with the control handle, the straight line between the proximal end and the distal end determines the axial direction, and accordingly determines the radial direction perpendicular to the axial direction and the circumferential direction around the axial direction. When used to refer to the structure, the "end" in the text refers to the end point of the structure or a certain point or region in the direction or a specific structure connected to the point or region.

[0155] The present application provides a control mechanism of an artificial implant, which comprises a base 10, a pull wire 11 and a locking member 13. The base 10 has a locking hole, the pull wire 11 has a free end 111 which can be threaded through or detached from the artificial implant 60, and the locking member 13 is located at the distal end of the base 10 as a whole. The locking member 13 is rotationally connected with the base 10 to lock the free end 111 of the pull wire 11. The base 10 has a relative distal end 32 and proximal end 31, and an axial direction extending between the distal end 32 and the proximal end 31. The proximal end, the distal end and the axial direction are also applicable to other components of the control mechanism, as well as the control handle and the delivery system of the following embodiments, unless otherwise specified. The free end 111 is the end of the pull wire 11 which is first threaded through and finally detached from the artificial implant 60, and can also be understood as the farthest end of the pull wire 11 when it is straightened. The other end of the pull wire 11 opposite to the free end 111 is a control end, which can be directly fixed to the base 10 or extend controllably towards the proximal end.

[0156] The free end 111 has a first state (as shown in Figure 1a ) of being limited to the base 10 and a second state (as shown in Figure 1b ) of being released from the limitation.); the lock 13 is movably coupled with the base 10, and the lock 13 cooperates with the free end 111 of the pull wire 11 to switch the state of the free end 111. In the first state, the free end 111 is combined with the lock 13, and the lock 13 is combined with the base 10 to limit the pull wire 11 from being separated from the lock 13, at this time, the free end 111 can be understood as being relatively fixed to the lock 13; in this state, the pull wire 11 is always connected with the artificial implant 60, and the expansion process (i.e. the expansion degree) of the artificial implant is adjusted according to the length of the pull wire 11 exposed outside the control mechanism, and the expansion / contraction speed of the artificial implant is controlled according to the change rate of the pull wire.

[0157] In the second state, the free end 111 is separated from the lock 13, at this time, the free end 111 can be understood as being released, so as to remove the mutual connection relationship between the artificial implant and the control mechanism, and then the control mechanism as a whole can be withdrawn to the outside of the body, and the artificial implant is left in the predetermined position in the body.

[0158] Wherein the lock, the base and the pull wire are pre-assembled outside the body, the pull wire 11 is threaded from the proximal end of the base, then threaded from the distal end of the base, and then threaded around the artificial implant and combined with the lock 13.

[0159] After being released and separated from the artificial implant, the driving control end is used to move the pull wire 11 to the proximal end to recover the pull wire; when the artificial implant is recovered, the pull wire 11 is in the first state, and the control end 113 is operated to reduce the length exposed outside the control mechanism.

[0160] The lock 13 is located at the distal end of the base 10, which is beneficial to observation and operation during pre-assembly outside the body, and is convenient for assembly, especially that the lock 13 and the base 10 are not nested in the radial direction, forming a sufficient radial space for the pull wire to pass through, and making the pull wire more smooth during movement. In addition, the maximum radial dimension of the base 10 and / or the lock 13 can be correspondingly reduced, which is convenient for intracorporeal intervention delivery. Of course, the control mechanism of the present application and the following other embodiments containing the control mechanism of the present embodiment are also applicable to simulation training of intracorporeal intervention delivery operation. The inside of the prosthesis (such as an artificial organ for simulation training or observation) can also be understood as being outside the body.

[0161] The control end 113 of the pull wire 11 can be extended to be controlled by a control handle, and the movement mode can change the length of the pull wire exposed outside the base 10, which can be axial movement, rotation or winding, etc.

[0162] The artificial implant 60 is a cylindrical structure and has a corresponding circumference. The pull wires 11 are arranged in multiple lines. The control ends 113 of each line of pull wires 11 can be controlled independently or moved synchronously. The positions where each pull wire 11 interacts with the artificial implant 60 are arranged at intervals along the circumference of the artificial implant 60, which can improve the synchronicity of the contraction and expansion of the artificial implant 60. For example Figure 3 The pull wires 11 are three, and the positions where they interact with the artificial implant 60 are three and arranged at intervals along the circumference of the artificial implant.

[0163] Correspondingly, the locking areas 101 are multiple, and the free ends 111 of each line of pull wires 11 correspond to one of the locking areas 101 in the first state. This avoids interference between the pull wires 11. The multiple locking areas can be separated by the structure of the base itself, or additional separation components can be provided on the base.

[0164] The control ends 113 of each line of pull wires 11 can be directly extended to the control handle or indirectly transmitted through intermediate components, so as to reduce the risk of mutual entanglement of multiple pull wires 11. For example Figure 4 The control mechanism further includes a second shaft 23, and the control ends 113 of each line of pull wires 11 are connected to the second shaft 23. The second shaft 23 is operated to synchronously control each line of pull wires 11.

[0165] As shown in Figure 5 The artificial implant 60 has an axial direction in space, and one end of the axial direction is a wire control end 601, which can be a distal end or a proximal end of the artificial implant 60. In this embodiment, the wire control end 601 is at the proximal end of the artificial implant, and the wire control end 601 has a hole 603 for the pull wire (not shown in the figure for clarity) to pass through,

[0166] The hole can be formed in various ways. For example, the artificial implant includes a hollow part for forming the hole, which is one of the structural gaps of the artificial implant; or the hole is directly punched (for example Figure 5 ); or it is independently arranged on the artificial implant (such as welding, etc.).

[0167] The hole 603 is multiple and isolated from each other. In the expanded state, the same pull wire 11 passes through at least two holes 603.

[0168] The free ends 111 of the pull wires 11 can limit the complete separation of the artificial implant 60 from the control mechanism in the first state, but the length of the pull wire exposed outside the base can be adjusted to allow the artificial implant to deform to a certain extent, or the position of the artificial implant relative to the base to change. Therefore, when the free ends 111 of the pull wires 11 remain in the first state, the artificial implant 60 can still have multiple states according to the deformation degree, for example, it has a relative

[0169] In the expanded state, the wire control end 601 expands radially away from the base 10 (as shown in Figure 6a ), and the same pull wire 11 does not coincide in the to-and-fro path around the artificial implant 60;

[0170] In the contracted state, the wire control end 601 contracts radially towards the base 10 (as shown in Figure 6c );

[0171] In the intermediate state, the wire control end 601 is between the expanded state and the contracted state (as shown in Figure 6b ).

[0172] As shown in Figures 5 to 7a , a plurality of eyelets 603 are arranged circumferentially in sequence, and in the expanded state, the same pull wire 11 passes through at least two eyelets 603, i.e. one pull wire 11 can act on two circumferential positions of the wire control end 601. In the preferred embodiment, the number of eyelets 603 is twice the number of pull wires 11, and the same pull wire 11 corresponds to two eyelets 603. This makes the contraction and expansion of each circumferential position of the wire control end 601 of the artificial implant 60 synchronous, and reduces the number of pull wires, avoiding entanglement and friction at the proximal end of the pull wire, which can correspondingly reduce the space for accommodating the pull wire.

[0173] At least two pull wires are configured for the artificial implant 60 as a whole. In addition, only one pull wire is allowed to pass through each eyelet to avoid interference caused by repeated passing.

[0174] Figure 7a As can be seen, in this state, the extension direction (radial) of the pull wire between the artificial implant 60 and the base 10 is perpendicular to the unlocking movement direction (circumferential) of the lock, which is more convenient for unlocking.

[0175] For example Figure 7a and Figure 7b , the same pull wire 11 passes through the to-and-fro path of the artificial implant to form a triangular area, i.e. the to-and-fro path does not coincide, otherwise the extension path of the pull wire 11 is a single straight line or curve, and will not form an area. The relationship between the path of the pull wire 11 and the base 10 and the lock 13 is described in the following embodiments.

[0176] As shown in Figures 10 to 15The base 10 has a locking area 101, and the locking member 13 has a positioning portion 131 that enters or moves out of the locking area 101 during rotation. The positioning portion 131 cooperates with the free end 111 of the pull wire 11 to limit the artificial implant 60; the interior of the base 10 has a first cavity 103, and the proximal side of the base 10 has a first opening 104 that communicates with the first cavity 103, and the outer peripheral surface of the base 10 has a second opening 108 that communicates with the first cavity 103; the pull wire 11 passes through the first cavity 103, and one end thereof (i.e., the control end) extends out of the base 10 proximally through the first opening 104, and the other end of the pull wire 11, i.e., the free end 111, extends out of the base 10 through the second opening 108 to connect to the artificial implant 60.

[0177] The pull wire 11 passes through the first cavity 103 of the base 10 to reduce the radial space occupied, and the locking piece 13 is not in the first cavity 103, so the movement of the pull wire 11 will not be interfered by the locking piece 13, making the movement of the pull wire 11 smoother and facilitating the expansion control of the artificial implant.

[0178] The locking area 101 can be within the overall outer contour of the base 10 to accommodate the free end in the first state, and the locking area 101 can be open toward the distal end to optimize the extension path of the pull wire 11. For example, the locking area 101 is located at the second opening.

[0179] In conventional techniques, for example Figure 8 、 Figure 89 , showing how locking element 13 slides axially, disengaging positioning portion 131 from locking region 101 and allowing pull wire 11 to detach from the artificial implant. In this embodiment, positioning portion 131, as a portion of locking element 13, undergoes at least circumferential displacement during operation, reducing or even eliminating axial travel variation of locking element 13, reducing the axial space occupied by related components and even the proximal control handle, and further facilitating the configuration of the transmission mechanism.

[0180] In the first state, the pull wire 11 is constrained by the artificial implant 60 and primarily moves in the radial direction. In the second state, the free end of the pull wire 11 is free. The second opening 108 encompasses the radial sidewalls and distal end surface of the base 10, facilitating movement of the pull wire 11 in all directions in the first state and rapid and smooth retraction in the second state.

[0181] Regarding the cooperation between the free end 111 and the positioning portion 131, in one embodiment, the free end 111 has a ring 115a. When the free end 111 is in the first state, the positioning portion 131 penetrates the ring 115a. When the free end 111 is in the second state, the positioning portion 131 withdraws the ring 115a. The ring 115a can be configured independently (e.g. Figure 16a ) or by winding the wire 11 itself (such as Figure 16b). The pull wire 11 is single-stranded or multi-stranded, for example, it can be a single strand extending to the control end 113, and for example, it can be double-stranded and extending to the control end 113 in parallel, or it can be double-stranded and extending to the control end 113 in parallel after being stranded.

[0182] Along the circumference of the base 10, a plurality of locking areas 101 are arranged at intervals, and the positioning part 131 enters or moves out of each locking area 101 in turn with the movement of the locking piece 13.

[0183] In an embodiment, as shown in Figure 12 , The control mechanism further comprises a third shaft 25 fixedly connected to the base 10, the proximal end of the third shaft 25 extends and can be controlled by the control handle, and the third shaft 25 can keep the base 10 relatively fixed in the circumferential direction, so that the positioning part 131 can rotate relative to the base 10. In the radial direction, the third shaft 25 is outside the circumference of the second shaft 23. Both the third shaft 25 and the second shaft 23 are tubular, and the distal end of the second shaft 23 has a plurality of connection holes 231 for connecting the control end of the pull wire, and the connection holes 231 correspond one-to-one to the pull wire, specifically including mutual correspondence in number and position. In the figure, the connection holes 231 are three and arranged at intervals in the circumferential direction.

[0184] As shown in Figure 13a and Figure 13b , in an embodiment, a plurality of notches 232 are arranged at intervals in the distal end wall of the second shaft 23, and a connection arm 233 is formed between adjacent notches 232, and the connection hole 231 is arranged at the distal end of the connection arm 233. During the movement of the second shaft 23 to the distal end or the proximal end, the connection arm 233 deforms adaptively according to the movement of the pull wire, and the deformation at least includes radial deformation. In an embodiment, a deformation hole 234 is arranged at the proximal end side of the connection hole 231 of the connection arm 233.

[0185] As shown in Figures 17 to 18b , in an embodiment, a plurality of partition pieces are arranged circumferentially on the base 10, and adjacent partition pieces separate the second openings 108, so that a plurality of second openings 108 are arranged at intervals in the circumferential direction of the base 10, and the partition pieces are the ribs 102 in the figure. The strip structure minimizes its own circumferential span as much as possible, so that the circumferential span of the second opening is maximized, facilitating the arrangement of the pull wire, for example, one pull wire extends out of one locking area and returns to the same locking area; or for one pull wire to extend out of one locking area and return to the adjacent locking area, so that the two action points can be close enough. At the same time, the rib 102 also serves as a reinforcing rib to maintain the basic strength requirement of the base.

[0186] The free end 111 extends out of the base 10 through the corresponding second opening 108 in the first state, returns to the same locking area (as shown in Figure 18a ) corresponding to the second opening 108 after passing through the artificial implant, or returns to a position adjacent to the second opening 108 in the circumferential direction (as shown in Figure 18b ).Figure 18b ).

[0187] As Figure 19 , the position circumferentially adjacent to the second opening 108 can be another locking zone 101 adjacent to it, or a channel configured separately for the pull wire to pass through. The channel can be formed in the same principle as the locking zone, for example, the second opening 108 has six openings, three of which are spaced apart to form channels for the free end of the pull wire to extend out of the base 10, and the other three are spaced apart to form the locking zone 101, for example Figure 19 , in the circumferential span, the span of the locking zone 101 is α, and the span of the channel adjacent to it in the circumferential direction is β, satisfying α / β = 1.1-2.

[0188] As Figure 17 , all the ribs 102 converge and are fixed at the distal end of the base 10, and converge into a ring structure 107. All the ribs 102 are circumferentially continuously distributed at the proximal end 32 of the base 10 to form a cylindrical structure. The inner cavity of the cylindrical structure is part of the first cavity 103. The inner hole of the ring structure 107 can be used to pass through other pipe fittings, such as the first shaft described below.

[0189] As Figure 20a and Figure 20b , in an embodiment, the base 10 is provided with a lock hole 105 for the positioning part 131 to insert into. The positioning part 131 has:

[0190] A locked state, the positioning part 131 is inserted into the lock hole 105, limiting the free end 111 of the pull wire 11 from being pulled out (as Figure 20a ) ;

[0191] An unlocked state, the positioning part 131 exits the lock hole 105, allowing the free end 111 of the pull wire 11 to be pulled out (as Figure 20b ) ;

[0192] As Figure 21a , the two ribs 102a and 102b are separated by a locking zone 101a, and the free end 111 of the pull wire 11 is located in the current locking zone 101 in the first state. The lock hole 105a and the lock hole 105b are correspondingly provided on the opposite sides of the two ribs, of course, the lock hole can also penetrate the rib where it is located. One section of the positioning part 131 is located in the locking zone 101a, and the two ends of the section are inserted into the lock hole 105a and the lock hole 105b, respectively. In combination with the movement direction of the lock piece 13, the opening of the lock hole 105 is oriented in the circumferential direction of the base 10.

[0193] When the positioning part 131 moves in the first direction (e.g. Figure 20b X), the free end 111 switches from the second state to the first state, the lock hole 105 penetrates the rib 102 where it is located in the first direction, and the lock hole 105 has opposite forward and backward openings, wherein the forward opening faces the first direction.

[0194] In quantity, the plurality of the locking holes 105 are provided in the plurality of the ribs 102, and the positioning part 131 has opposite end 13110 and head end 13130. The head end 13130 is inserted into (as shown in Figure 20a ) or separated from (as shown in Figure 20b ) the locking holes 105 in sequence with the rotation of the locking member 13. Taking the insertion as an example, the head end 13130 is sequentially combined with the locking hole 105a, the free end 111a, the locking hole 105b, the locking hole 105c, the free end 111b, the locking hole 105d, the locking hole 105e, the free end 111c and the locking hole 105f, as shown in Figures 21a to 21c . The separation sequence is opposite to the combination sequence. The sequential insertion is beneficial for the sequential combination between the positioning part and the pull wire during the in-vitro pre-assembly, which facilitates the assembly.

[0195] In the preferred embodiment, all the ribs 102 are provided with the locking holes 105, which are used for the sequential rotation of the positioning part 131 and provide a certain movement guide. During the rotation of the locking member into the locking holes, the head end 13130 is finally abutted against the side wall of one of the ribs 102 or is inserted into the corresponding locking hole, which serves as a limiting part.

[0196] When the positioning part 131 is in the form of a plurality of turns of a spiral, the positions of the locking holes 105 of the ribs 102 are adapted to the positioning part 131. The locking holes 105 on the same rib 102 are one or more. The plurality of the locking holes 105 are sequentially arranged along the extension direction of the rib 102.

[0197] Referring to Figure 22 , in one embodiment, the rib 102 has a bending section 1021 extending radially inward along one of the axial sections, and the locking hole 105 is located in the bending section 1021 of the corresponding rib 102. All the bending sections 1021 form an avoiding area 1022 (the dashed area in the figure), and the proximal end of the artificial implant is located in the avoiding area 1022 in the collapsed state. This is also beneficial for guiding the partial insertion of the loading section into the avoiding area 1022 and the alignment with the outer periphery of the base 10 during the retraction of the loading section.

[0198] In combination with the rotation characteristics of the locking member and the circumferential distribution of the pull wires, the positioning part 131 has a curved shape and a curved extension path around the circumference of the base. The curved arrangement can make full use of the circumferential space, maintain the necessary length of the locking member, realize the control of all the free ends of the pull wires by the same locking member, eliminate the axial size change of the control mechanism, retain the original function of the sequential cooperation between the locking member and the pull wires, and facilitate the cooperation and assembly of the locking member, the pull wires and the base during the assembly stage.

[0199] Specifically, the opening of the locking hole is directed to the circumference of the base, the positioning part is in the form of a rod, which can be a straight rod or a curved rod, and the number of the rod is one and cooperates with all the free ends of the pull wires. The positioning part is inserted into or separated from the locking hole with the rotation of the locking member. For example, as shown inFigure 23a 、 Figure 23b The positioning portion 131 is a helical structure, and the helical structure is at least one turn. For example, the helical structure is a multi-turn structure, and each turn is arranged in an axial direction (each turn is circumferentially arranged around the base). The generatrix of the helical structure can be a slant line (away from or close to the axis of the base) or a straight line, for example, the helical extension path is a cylindrical helix or at least partially a conical helix.

[0200] As Figures 24a to 24c The locking member 13 has a connecting portion 135 at the distal end of the base 10, and the control mechanism further comprises a first shaft 21 in driving cooperation with the connecting portion 135, to drive the locking member 13 to rotate relative to the base 10. The proximal end of the first shaft 21 is connected to and controlled by the control handle.

[0201] Among them, along the winding direction of the helical structure, the positioning portion 131 has opposite distal end 13110 and head end 13130 as a whole, one end of which is fixed to the connecting portion 135, and the other end is relatively free. The connection between the positioning portion 131 and the connecting portion 135 includes separate connection, such as welding or assembly, or one-piece molding.

[0202] In an embodiment, a positioning mechanism for pre-assembling and maintaining the axial position of the connecting portion 135 and the base 10 is arranged between the connecting portion 135 and the base 10. The connecting portion 135 can be a tubular structure extending at a constant diameter, and the positioning mechanism includes a first end face arranged at the proximal end of the connecting portion and a second end face arranged at the distal end of the base and abutting the first end face. When pre-assembled, the first end face abuts the second end face, and the positioning portion is fitted into place with the locking hole of the base.

[0203] Among them, the head end 13130 of the positioning portion 131 needs to adapt to the radial position of the locking hole, and the part close to the distal end 13110 needs to be fixedly connected with the connecting portion 135, and the outer diameter of the connecting portion has a large deviation from the radial position of the locking hole, so the helical extension path of the positioning portion 131 is a conical helix; or as Figure 25a and Figure 25b The proximal end of the connecting portion 135 is radially expanded to form a connecting segment 1351, and the distal end of the base 10 has an extension segment 106, and the connecting segment 1351 and the extension segment 106 are nested with each other. In the figure, the connecting segment 1351 is a cylindrical structure and is sleeved on the outer periphery of the extension segment 106, and the connecting segment 1351 compensates for the above-mentioned deviation, so that the helical extension path of the positioning portion 131 is a cylindrical helix. At this time, the bottom wall of the connecting segment 1351 is the first end face.

[0204] The connecting portion 135 movably sheaths the outer periphery of the distal end of the first shaft 21, and the connecting portion 135 is axially separable from the distal end of the first shaft 21. When the connecting portion 135 and the first shaft are combined, the connecting portion 135 and the first shaft can be kept synchronous in the circumferential direction, and at least the proximal end of the first shaft 21 can be controlled to drive the locking member 13 to rotate. As for axial separation, the two can be separated from each other to be out of engagement or combined with each other to be synchronous, and the engagement relationship of the two is switched according to the operation requirement.

[0205] As Figure 28 , regarding the threading path of the pull wire, the pull wire 11 has an advancing section 112, a returning section 114, and an intermediate section 116 therebetween in the first state, and the three sections form a triangular structure of the to-and-fro path in the above-described embodiment. The free end 111 is arranged at the end of the returning section 114. In an embodiment, the positioning portion is a helical structure with multiple turns, and there is an axial gap between adjacent turns. The advancing section can pass through the axial gap near the proximal end of the positioning portion and interact with the same to form a first action point (X1 described below). The returning section is connected to the positioning portion and interacts with the same to form a second action point (X2 described below). The two action points are close to each other, so that the movement of the artificial implant at different positions is more synchronous during the recovery and expansion of the artificial implant.

[0206] In another embodiment, as Figure 20a , the advancing section 112 directly extends out of the locking zone 101 (without passing through the axial gap) and interacts with the same to form a first action point (X1 described below). The returning section 114 is connected to the positioning portion 131 and interacts with the same to form a second action point (X2 described below). In combination with the foregoing, the space of the locking zone 101 is larger than the axial gap, facilitating the threading of the pull wire. And in the pre-assembly, the pull wire can be threaded through the base first, and then the locking member is combined with the base to complete the rotational engagement, and the free end is inserted at the same time, facilitating the assembly. The pull wire 11b is in the state after threading, and the thickened portions are the advancing section 112 and the returning section 114 of the pull wire 11b, respectively. As Figure 7a , the pull wire 11b forms two action points (X1, X2) at the locking zone 101 or the positioning portion 131, and two action points (Y1, Y2) with the artificial implant.

[0207] Here, the prior art is explained as follows: Figure 26 In the prior art, the artificial implant 60 is circumferentially arranged with three eyelets 603, and there are three pull wires. The threading path is referred to the pull wire 11c, and the to-and-fro path of the pull wire 11c coincides. During the folding process, the action force generated by the pull wire is only radial, and the artificial implant will generate corresponding stress in the circumferential direction and react on the pull wire, so that the force required to be applied to the pull wire gradually increases, affecting the operation feeling.

[0208] But the pull wire of the embodiment is triangular, and in addition to the radial action force, an action force on the connecting line of the two connecting points (Y1, Y2) is generated (as Figure 7aThe middle solid arrow shows that the tension of the pull wire is smaller than the prior art, and the operation is more delicate.

[0209] In the conventional technology, the interval between two adjacent holes 603 is far apart (i.e. large circumferential span), the holes 603 are arranged on the connecting ears 605 (as shown in Figure 27a ), and the adjacent connecting ears 605 are independently connected to the pull wire. During the folding process, the adjacent connecting ears 605 may finally be misaligned and stacked (as shown in Figure 27b ), which affects the subsequent expansion. However, the threading path of the pull wire of the present embodiment makes the connecting ears 605 and the structural gap mostly or entirely controlled by the pull wire, reducing or even eliminating the misalignment and stacking problem during folding (as shown in Figure 7b ).

[0210] When the two action points (X1, X2) are in the same locking area and adjacent to each other, the forward and return paths of the pull wire are approximately equilateral triangles, i.e. Figure 7a The lengths of the two thickened forward and return segments 112 and 114 are equal, and the moving speeds of the corresponding forward and return segments 112 and 114 are the same, which improves the synchronization of the folding or expansion of the artificial implant 60. If, as shown in Figure 28 , the circumferential span of the two action points (X1, X2) is large, the lengths of the corresponding forward and return segments 112 and 114 are different, and the different moving speeds of the corresponding forward and return segments 112 and 114 cause abnormal folding / expansion of the artificial implant.

[0211] In order to improve the synchronization of the folding and expansion of the artificial implant, the prior art needs to configure more pull wires (e.g. more than six), but the spatial arrangement of each pull wire at the proximal end needs to be considered, and each pull wire may be too close to each other and cause friction or entanglement. The threading method of the present embodiment requires fewer pull wires, thereby meeting the spatial requirements. The control mechanism described above can be installed in a delivery system, which further includes a control handle at the proximal end of the delivery system and an inner shaft assembly connected between the control handle and the control mechanism. The inner shaft assembly includes the first shaft, the second shaft, and the third shaft.

[0212] In some embodiments, the delivery system further includes an outer sheath arranged around the inner shaft assembly. During the interventional delivery process, the distal end of the outer sheath wraps the control mechanism and part or all of the artificial implant.

[0213] Referring to Figure 11 , Figure 29 , Figure 30a and Figure 30bThe application also provides a locking mechanism for connecting the artificial implant with the delivery system, which comprises a first shaft 21, a pull wire 11, a third shaft 25 and a linkage assembly. The distal end of the first shaft 21 is fixed with a loading segment 211, which is open towards the proximal end and used for accommodating the distal end of the artificial implant 60. The pull wire 11 has a free end 111, which can be threaded through or detached from the artificial implant 60. The third shaft 25 is slidingly sleeved outside the first shaft 21, and the locking assembly is mounted on the third shaft 25. The artificial implant 60 is bound to the locking assembly by the pull wire 11 when loaded. The locking assembly comprises a lock piece 13 and a base 10, which have a locking state (corresponding to the first state of the pull wire) and a release state (corresponding to the second state of the pull wire) of disengagement. Each state respectively restricts and allows the pull wire 11 to be detached from the artificial implant 60. The relationship between the proximal end of the artificial implant and the pull wire 11 and the locking assembly can refer to the foregoing embodiments. For example, the locking mechanism can further comprise a second shaft 23, which is slidingly sleeved between the first shaft 21 and the third shaft 25 and has a proximal end controlled by a control handle. The proximal end of the pull wire 11 is connected to the distal end of the second shaft 23.

[0214] The linkage assembly acts between the first shaft 21 and the lock piece 13 to selectively link them. It can be understood that the first shaft 21 and the lock piece 13 have a combined state of mutual cooperation and the lock piece 13 is driven by the first shaft 21 to move, and a separated state of disengagement so that they are independent of each other. The combined time should be after the artificial implant 60 is accurately positioned and expanded, and before the delivery system is ready to be withdrawn. The combination / separation of the two can be at least one of the relative movement of the other, and in combination with the foregoing, for example, the lock piece 13 is located at the distal end of the base, the linkage assembly comprises two cooperating parts, one of which is connected to the loading segment 211, and the other is connected to the lock piece 13. The axial movement of the loading segment 211 can make the two cooperating parts link or disengage. In one embodiment, after the artificial implant 60 is accurately positioned and expanded, the distal loading segment 211 is first moved proximally and combined with the lock piece 13. At this time, the loading segment 211 is necessarily located in the artificial implant 60 in the axial position. Then rotate the first shaft 21 and release the control of the pull wire 11 through the linkage assembly. During the rotation operation, the proximal end of the loading segment 211 is not easy or even will not interfere with the distal end of the artificial implant, for example, the loading segment 211 is hung on the distal end of the artificial implant. And it is not necessary to separately provide a driving tube for the lock piece, which simplifies the structure.

[0215] The two cooperating parts are an axial slidingly separated linkage key and a linkage groove, and the linkage key rotates relative to each other when inserted into the linkage groove. Of course, the two cooperating parts can also be a linkage key and a linkage groove that can be relatively rotated and separated, and the linkage key axially links relative to each other when inserted into the linkage groove. Among them, the linkage key is multiple, the loading segment and the lock piece are at least partially tubular, and the multiple linkage keys are arranged in the circumferential direction of the tubular part. Correspondingly, the linkage groove is multiple.

[0216] Referring to Figures 31 to 34b , in combination with the above-mentioned structure of the lock member 13, in an embodiment, at least a portion of the lock member 13 is a connecting portion 135, and the first shaft 21 selectively cooperates with the connecting portion 135 through a linkage assembly and drives the lock member 13 to rotate relative to the base 10. The linkage key 1352 is radially protruded from one of the connecting portion 135 and the first shaft 21; the linkage slot 2141 is cooperated with the linkage key 1352 and is arranged on the other one of the connecting portion 135 and the first shaft 21, and the linkage key 1352 and the linkage slot 2141 are open to the end surface of the one in which they are arranged. In the illustration, the linkage key 1352 is arranged on the distal end of the connecting portion 135, and the linkage slot 2141 is arranged on the loading segment 211. The rotational linkage of the two is that the sidewall of the linkage slot 2141 is abutted against the sidewall of the linkage key 1352 in the circumferential direction (as shown in Figure 31 ). The connecting portion 135 is a cylindrical structure, and the linkage key 1352 is a sheet. In an embodiment, the linkage key 1352 is distributed in 2-4 places in the circumferential direction, for example, the linkage key 1352 is 2 places.

[0217] Preferably, the slot of the linkage slot 2141 is provided with a flared structure 2142 for guiding the insertion of the linkage key 1352, and the distal end surface of the linkage key 1352 is provided with a tapered structure 1354 for guiding the insertion of the slot.

[0218] The loading segment 211 is nested with the connecting portion 135 in the combined state, and the inner circumferential wall of the loading segment 211 is provided with the linkage key 1352, so that the loading segment 211 is inside the artificial implant in the combined state. The inner circumferential wall of the loading segment 211 is provided with a support 212, and the support 212 is fixed to the distal end of the first shaft 21, wherein a cooperating portion (i.e. the linkage key) is arranged on the support 212. The support 212 and the loading segment 211 are provided with a limiting structure for limiting the axial separation of the two.

[0219] In an embodiment, the limiting structure includes a positioning sheet 2131 radially protruded from the outer circumferential wall of the support 212, and a positioning slot arranged on the inner circumferential surface of the loading segment 211 and cooperated with the positioning sheet 2131.

[0220] The support 212 is a cylindrical structure, and the outer circumferential wall is partially everted to form the positioning sheet 2131. The support 212 includes an outer cylinder 2130 connected with the loading segment 211, and an inner cylinder 2140 with the linkage key fixed to the first shaft 21. The inner cylinder and the outer cylinder can be integrally formed or in a split structure, for example, bonded, etc. The outer circumferential wall of the outer cylinder 2130 is partially everted to form the positioning sheet 2131, and the inner cylinder 2140 is partially recessed to form the linkage slot 2141.

[0221] The loading section 211 has a guide head 215 at the distal end and connected with the first shaft 21, and a loading part 216 connected with the guide head 215 for accommodating the distal end of the artificial implant. The support 212 is arranged in the guide head 215. The distal end of the guide head 215 is tapered towards the distal end, and the proximal end surface is flat and perpendicular to the axial direction. In the combined state, the proximal end surface of the loading part 216 abuts against the base 10. Specifically, in the combined state, the proximal end surface of the loading part 216 abuts against the rib 102 of the base 10 according to the foregoing embodiment. In an embodiment, the loading section 211 is equal in diameter to the base 10, and in the combined state, the outer circumferential surfaces of the two are flush.

[0222] In the rotation unlocking process, the locking member moves distally. In an embodiment, in the combined state, the loading section 211 and the locking member 13 have an axial gap L1 in the axial direction for the connecting part to move distally. Similarly, the proximal end surface of the guide head is away from the positioning part 131 and has the same axial gap L1 as described above. The axial gap L1 is greater than the distal movement of the locking member 13.

[0223] As Figure 35 , the distal end of the first shaft 21 is fixed with a tubular extension pipe 27 extending out of the base, the locking member 13 is sleeved on the outer periphery of the extension pipe 27, and the loading section 211 is arranged at the distal end of the extension pipe 27. In an embodiment, the first shaft 21 is sleeved and connected at the proximal end of the extension pipe 27, i.e. the outer diameter of the first shaft 21 is greater than the outer diameter of the extension pipe 27. The distal end of the first shaft 21 extends close to the base 10, and the proximal end extends in the same diameter and is connected to the control handle. The relatively thick pipe diameter facilitates force transmission and control. The relatively thin pipe diameter of the extension pipe 27 facilitates the arrangement of the distal locking assembly, the loading section and other components, and reduces the overall radial size. The proximal end of the extension pipe 27 extends into the base and is connected and fixed with the first shaft 21. In the following embodiments, the extension pipe 27 is regarded as part of the first shaft 21 unless otherwise specified.

[0224] As Figures 35 to 38 , the present application also provides a loading structure of an artificial implant. The artificial implant 60 comprises an inner frame 61, and the inner frame 61 has a plurality of arm parts 63 on the outer periphery. Each arm part 63 and the inner frame 61 form a first gap capable of accommodating the original tissue. The loading structure comprises a first shaft 21 and a loading section 211. The inner frame 61 is sleeved on the outer periphery of the first shaft 21 in the compressed state. The loading section 211 is tubular and fixed at the distal end of the first shaft 21. The loading section 211 is open towards the proximal end. The whole or at least the distal end part of the inner frame 61 is accommodated in the loading section 211. The peripheral wall of the loading section 211 is provided with a avoiding opening 217, and at least a part of the arm part 63 is located in the avoiding opening 217.

[0225] The loading section 211 binds the distal end of the artificial implant 60, keeps the artificial implant in a folded state, ensures safe interventional delivery, and allows the arms 63 to enter the avoidance opening 217 in the section of the loading section 211 with the largest radial space, i.e., the aforementioned loading portion 216. Compared with the prior art structure that completely wraps the artificial implant, the radial size of the loading section of the present embodiment is smaller, which is beneficial to interventional delivery.

[0226] In the loading state, the arms are in a radial relationship with the loading section, and the method for releasing the arms from the binding of the loading section is as follows: Figure 36a The arms 63 are at least partially located in the loading section 211; and the loading section 211 is moved axially to release the binding of the loading section 211. If there is a catheter sheath 70 wrapped outside the loading section 211, the catheter sheath 70 needs to be moved first.

[0227] Alternatively, as shown in Figure 36b and Figure 36c , the loading structure includes a catheter sheath 70 that is slidingly mounted on the outermost side of the inner shaft assembly, and the arms 63 are located between the loading section 211 and the catheter sheath 70. After the catheter sheath 70 is moved, the binding of the arms 63 is released. In an embodiment, the distal end of the artificial implant is located in the loading section, and the proximal end is located outside the loading section and in the catheter sheath.

[0228] The outflow side 632 of each arm 63 is fixedly connected to the inner frame 61, the inflow side 631 is expanded to form a first gap with the inner frame 61, and the inflow side 631 is located in the avoidance opening 217. The artificial implant includes an inner frame that defines a blood flow passage, an outer periphery of the inner frame has a plurality of arms, each arm and the inner frame form a first gap that can accommodate native tissue, and the inner frame is connected with a leaflet that controls the blood flow passage. The inner frame 61 and the arms 63 are fixedly connected in a separate structure or adopt an integrated structure. The inner frame 61 and the arms 63 are integrally cut from a pipe blank, and the inflow sides of the inner frame 61 and the arms 63 are away from each other along the axial direction of the pipe blank. The inner frame 61 is a radially deformable cylindrical structure, and the inside is a blood flow passage 604. The leaflet is connected to the inner frame 61 to change the opening degree of the blood flow passage. The arms 63 are an integral annular structure, and the outflow side 632 of each arm 63 is fixedly connected to the inner frame 61.

[0229] As shown in Figures 39 to 40The embodiment of the present application also provides an interventional delivery system of artificial implants, which comprises a catheter sheath 70 (i.e. the outer sheath described above), a bending assembly, an inner shaft assembly and a control handle 3; the catheter sheath 70 is used to build an interventional channel extending from outside the body to the vicinity of a lesion, and the proximal end of the catheter sheath 70 is provided with a fixing seat 7200 (located outside the body); the distal end of the bending assembly can be controlled to change the pointing direction, and the bending assembly slides through the fixing seat 7200 to further extend towards the proximal end; the distal end of the inner shaft assembly is provided with a loading section for connecting the artificial implants 60, and the loading section is always exposed to the distal end of the bending assembly; the proximal end of the control handle 3 is connected to the bending assembly and the inner shaft assembly, the control handle 3 is located on the proximal side of the fixing seat 7200 and the distance between the control handle 3 and the fixing seat 7200 can be adjusted. The catheter sheath 70 of the embodiment is used to assist in the recovery of artificial implants.

[0230] The specific catheter sheath can reach a relatively far surgical site, and is used to wrap the control mechanism in the above-mentioned embodiments, the proximal end of the artificial implant and / or the loading section during the interventional delivery process. The catheter sheath 70 comprises a tube body 51, the tube body 51 comprises a main body section 510 and a deformation section 520, the fixing seat 7200 is connected to the proximal end of the main body section 510, and the deformation section 520 is located at the distal end of the main body section 510. In an embodiment, the fixing seat 7200 is a hemostatic valve, and the hemostatic valve can adopt the prior art.

[0231] The bending assembly comprises:

[0232] A bending sheath tube 430 is fixed to the control handle 3 at the proximal end;

[0233] A bending member is fixed to extend to the distal end of the bending sheath tube 430 and acts on the catheter sheath at one end, and is controlled by the bending driving mechanism at the other end. The bending member can be a wire, a tube or a combination of a wire and a tube. For example, the bending member is a bending wire fixed to the sheath tube, and the bending wire drives the bending tube to bend the bending sheath tube 430.

[0234] The embodiment of the present application also provides a control method of an interventional delivery system, which is used for the interventional delivery of the artificial implants in the above-mentioned embodiments, and the delivery system further comprises the control mechanism in the above-mentioned embodiments, the control handle and the inner shaft assembly connected to the control handle and the control mechanism and the loading section. The control method comprises the following steps:

[0235] First, expand at least a part of the arm portion to register the first gap with the native tissue;

[0236] Drive the loading section 211 away from the inner frame 61 towards the distal end, so that the distal end of the inner frame 61 is expanded;

[0237] Expand the proximal end of the inner frame 61 by releasing the part of the pull wire 11 exposed to the base, so that the inner frame is deformed to the desired amplitude as a whole, and the pull wire 11 always controls the inner frame 61 during the process;

[0238] Moving the loading segment 211 proximally into the blood flow passage 604;

[0239] The pull wire 11 is released from the inner frame 61.

[0240] In detail, after the artificial implant is delivered to the predetermined position in the body, the loading segment 211 or the catheter sheath or the inner structure thereof is driven distally to move axially in the opposite direction (depending on the arrangement of the arm) until at least a part of the arm is released and expanded, the distal end of the inner frame is still constrained by the loading segment 211, and the first gap is matched with the native tissue. This embodiment is described in detail with reference to the drawings, taking the arrangement in which the arm is arranged between the loading segment and the catheter sheath 70 as an example:

[0241] As shown in Figure 41a and Figure 41b , the catheter sheath 70 is driven proximally or the inner structure of the catheter sheath is driven distally, the arm 63 is released from the constraint of the catheter sheath, and the arm 63 expands radially outward.

[0242] As shown in Figure 41c , the first shaft 21 is further pushed distally, the loading segment is released from the constraint of the artificial implant, that is, the distal end of the inner frame expands radially outward, and then the proximal end of the inner frame is prepared for expansion.

[0243] As shown in Figure 41d and Figure 41e , the third shaft 25 is kept stationary, the second shaft 23 is pushed distally, the control end 113 of the pull wire 11 moves distally 32, the part of the pull wire 11 exposed outside the base gradually elongates, the artificial implant 60 (mainly the proximal part) is allowed to gradually expand, and the pull wire outside the base 10 will gradually elongate in the direction of the arrow; the control end 113 continues to move until Figure 41d , the artificial implant 60 is in the expanded state (i.e., the expected amplitude), and after confirming that it matches the surrounding tissue as expected, the pull wire can be released.

[0244] When the pull wire is released, as shown in Figure 41f , the first shaft moves proximally until the loading segment enters the blood flow passage and the loading segment 211 is combined with the lock 13 through the linkage assembly, the first shaft 21 is rotated to drive the lock 13 to rotate relative to the base 10, and all pull wires 11 are sequentially released until all free ends 111 are completely separated from the lock 13.

[0245] Then, the second shaft 23 is withdrawn proximally, the control end 113 of each pull wire moves proximally 31, and the free end is separated from the corresponding eyelet 603, that is, it is completely separated from the artificial implant, which can also be understood as releasing the artificial implant.

[0246] Finally, as shown in Figure 41g , the entire delivery system is withdrawn to the outside of the body.

[0247] During the process of withdrawing the loading segment 211 into the blood flow channel, the pull wire is still in the first state to keep the components of the control mechanism and the artificial implant in a relatively fixed spatial posture, guiding the loading segment 211 to smoothly withdraw into the blood flow channel, reducing or eliminating the risk of the loading segment 211 hanging on the distal end of the artificial implant during withdrawal.

[0248] In addition, before the pull wire is unlocked, the recovery operation can be performed as needed, which generally needs to be combined with other components, such as the catheter sheath of the foregoing embodiments, and the specific operation is as follows: when the pull wire is in the first state, the control end of the pull wire is moved proximally, the proximal end of the artificial implant is retracted through the pull wire, and then the remaining components in the catheter sheath are moved proximally and withdrawn into the catheter sheath, or the catheter sheath is pushed distally to accommodate the artificial implant.

[0249] At the initial stage of recovery, there is a certain gap between the distal end of the catheter sheath and the proximal end of the artificial implant or they are already in abutting state, and in this state, there is a large force between the catheter sheath and the artificial implant, which is fed back to the control handle to make the operator feel a significant operating damping force. In this state, the artificial implant is recovered by referring to the following embodiments of the telescopic assembly and the push driving mechanism.

[0250] If there is a certain gap between the distal end of the catheter sheath and the proximal end of the artificial implant, the telescopic assembly can be directly driven to move the catheter sheath distally to quickly eliminate the gap; the inner shaft assembly can also be driven to move proximally to eliminate the gap; or the two methods can be combined to eliminate the gap until the operator significantly feels the operating damping force, proving that the catheter sheath and the artificial implant are in abutting action.

[0251] It should be noted that the position of the shaft in the figure has no limiting meaning, and the control end can be long or short or the pull wire can be directly connected to the control handle for direct winding and unwinding. The control of the pull wire can also be that the control end of the pull wire is extended and directly controlled by the control handle.

[0252] The foregoing control handle can adopt a conventional control handle, and the present specification provides another control handle, as shown in Figures 42 to 45 The control handle has opposite distal and proximal ends, and an axial direction extending between the distal and proximal ends. The distal end of the control handle 3 is provided with an axially telescopic push mechanism, which includes a telescopic assembly 38 and a push driving mechanism 39. The distal end of the telescopic assembly 38 is provided with an abutting piece 384, and the proximal end is movably connected to the control handle 3 along the axial direction. The push driving mechanism 39 is installed on the control handle 3 and is linked with the proximal end of the telescopic assembly 38.

[0253] The telescopic assembly 38 is used to adjust the distance between the abutting member 384 and the catheter sheath, and can keep the abutting member at any position. The telescopic assembly 38 can keep the distance between the abutting member 384 and the catheter sheath, facilitating the interventional delivery operation. When the artificial implant is recovered, the abutting member 384 is driven to move distally until it abuts against the proximal end of the catheter sheath, and then the inner shaft assembly is driven to move proximally relative to the catheter sheath 70 until the artificial implant is recovered into the catheter sheath 70;

[0254] Alternatively, the telescopic assembly 38 is driven to further move distally by the push driving mechanism 39 acting on the last stage 383, and the catheter sheath is driven to move distally relative to the inner shaft assembly until the artificial implant is recovered into the catheter sheath 70.

[0255] Alternatively, the artificial implant recovery operation can only be completed in a certain region in the body, so the telescopic assembly 38 is first elongated to the region, and at this time the distal end of the catheter sheath 70 is close to the control mechanism, reducing the distance between the catheter sheath and the artificial implant, and then the inner shaft assembly is withdrawn until the artificial implant is also located in the region, and finally the push driving mechanism 39 completes the recovery of the artificial implant according to the above operation.

[0256] Among them, the telescopic assembly 38 can quickly move to eliminate the distance between the abutting member 384 and the catheter sheath, which belongs to coarse adjustment. The push driving mechanism 39 can control and accurately adjust the axial movement distance of the telescopic assembly 38, which belongs to fine adjustment.

[0257] In an embodiment, the telescopic assembly 38 is arranged in one or more stages from distal to proximal. The distal end of the first stage 381 is provided with the abutting member 384, and the proximal end of the last stage 383 is connected with the push driving mechanism 39. Each stage of the telescopic assembly 38 is a cylindrical structure and is sequentially movably connected. It can not only ensure the adjustment distance, but also save the axial space and reduce the axial size of the control handle. One of the adjacent stages is an outer cylinder and the other is an inner cylinder. When the telescopic assembly 38 is elongated, the inner cylinder moves distally relative to the outer cylinder. Conversely, when the telescopic assembly 38 is shortened, the inner cylinder moves proximally relative to the outer cylinder. The telescopic assembly 38 has a first limit with the maximum length and a second limit with the minimum length. The telescopic assembly 38 includes the first stage 381, the intermediate stage 382 and the last stage 383 from inside to outside.

[0258] In an embodiment, a mutual cooperation retreat structure is arranged between adjacent stages. At least the proximal movement of the inner cylinder relative to the outer cylinder is limited, and the retreat structure needs to be released during operation. For the distal movement of the inner cylinder relative to the outer cylinder, the retreat structure can be limited or only provide a certain resistance, for example, the retreat structure can be released by applying external force.

[0259] In an embodiment, a control method for recovering an artificial implant by using an interventional delivery system is provided, which comprises:

[0260] An artificial implant and an interventional delivery system for delivering the artificial implant are provided, the interventional delivery system comprising:

[0261] A catheter sheath for establishing an interventional channel, a proximal end of the catheter sheath being provided with a fixing seat;

[0262] An inner shaft assembly, a distal end of the inner shaft assembly being provided with a loading section, at least a part of the artificial implant being located in the loading section and releasably connected with the inner shaft assembly before expansion of the artificial implant;

[0263] A control handle connected with a proximal end of the inner shaft assembly, the control handle being located on a proximal end side of the fixing seat, a distal end of the control handle being provided with a push mechanism capable of acting on the fixing seat;

[0264] The artificial implant is still connected with at least a part of the inner shaft assembly, and when the artificial implant is retrieved, the catheter sheath is driven to move relative to the inner shaft assembly so that the artificial implant is received into the catheter sheath.

[0265] The proximal end and the distal end of the embodiment are not strictly limited to installation positions, and can be orientation indications. For example, the push mechanism can extend to the control handle.

[0266] The relative movement between the catheter sheath and the inner shaft assembly can be movement of the catheter sheath to the distal end, or movement of the inner shaft assembly to the proximal end, or movement of the inner shaft assembly to the proximal end and movement of the catheter sheath to the distal end until the distal end of the catheter sheath approaches or contacts the artificial implant, eliminates the gap mentioned above, and waits for the next operation. When the artificial implant is retrieved, the push mechanism or other components can abut against the proximal end of the fixing seat to provide sufficient force transmission for the retrieval operation. The artificial implant, the catheter sheath, the inner shaft assembly and the control handle are as described above. Specifically, in an embodiment, the distal end of the catheter sheath approaches or contacts the artificial implant, the push mechanism is driven to abut against the fixing seat, and first, the telescopic assembly is elongated to the distal end until the first stage abuts against the fixing seat. The control push driving mechanism drives the telescopic assembly to move to the distal end as a whole and acts on the catheter sheath through the fixing seat to move the catheter sheath to the distal end until the retrieval of the artificial implant is completed.

[0267] The expansion of at least a part of the artificial implant relative to the inner shaft assembly includes deformation and expansion to the outside or expansion after the distal end side of the artificial implant is separated from the loading section or the catheter sheath. In an embodiment, the artificial implant is connected with the inner shaft assembly through a pull wire, and when the artificial implant is retrieved, the pull wire is kept in a tightened state to gather the proximal end side of the artificial implant, which is beneficial to the smooth entry of the proximal end of the artificial implant into the catheter sheath during retrieval. Before the retrieval, the shape of the artificial implant can be in an expanded state, and the pull wire needs to be tightened to gather the proximal end side of the artificial implant. When the artificial implant is retrieved, the proximal end of the arm part of the artificial implant enters the catheter sheath first, and the distal end of the arm part enters the catheter sheath adaptively with the movement of the catheter sheath relative to the artificial implant.

[0268] In one embodiment, a loading method for loading an artificial implant into a delivery system is provided, comprising:

[0269] An artificial implant and a delivery system are provided, the artificial implant comprising an inner frame with a plurality of arm portions around the outer periphery of the inner frame. The delivery system comprises:

[0270] A catheter sheath with a proximal end having a fixing seat;

[0271] An inner shaft assembly movably arranged in the catheter sheath, the inner shaft assembly having a loading section at the distal end thereof;

[0272] A control handle connected to the proximal end of the inner shaft assembly.

[0273] Specifically, the loading section is driven by operating the control handle, and the artificial implant in the expanded state is received and wrapped inside the loading section and the catheter sheath by operating the catheter sheath, so that the artificial implant is in the loaded state.

[0274] Before loading, the artificial implant is in the expanded state and is separated from the delivery system. In one embodiment, the connection between the artificial implant and the delivery system is achieved by threading a pull wire around the proximal end of the inner frame. With reference to the foregoing structure, the delivery system further comprises a control mechanism, which comprises a base connected to the inner shaft assembly, a lock piece movably cooperating with the base, and a plurality of pull wires; the inner shaft assembly is as described in the foregoing embodiments.

[0275] One end (i.e., the control end) of the pull wire is connected to and controlled by the control handle, and the other end (i.e., the free end) extends out of the base and, under the operation of the control handle, the length exposed outside the base is elongated to provide a sufficient length for the pull wire to be threaded around the proximal end of the inner frame and returned to the corresponding locking area of the base, waiting to be locked in the base and the lock piece, wherein the plurality of pull wires are locked one by one. During the locking process, the lock piece moves relative to the base in a rotating manner.

[0276] Subsequently, the control end of the pull wire is driven to move proximally by operating the control handle to tighten the pull wire, i.e., to shorten the length of the pull wire exposed outside the base, so as to radially compress the proximal end of the inner frame until it is close to the base. During the tightening process, all the pull wires are synchronously tightened.

[0277] Next, the distal end of the inner frame is compressed and loaded:

[0278] In one embodiment, the distal end of the inner frame is compressed, and the control handle is operated to drive the loading section to move proximally to receive the distal end of the inner frame. At this time, the arm portions are still in the expanded state and are not received by the loading section. The control handle is further operated to drive the catheter sheath to move distally to receive the arm portions and the proximal end of the inner frame. The method of compressing the inner frame can be compression by a compression device or manual compression in a cold water bath, etc.

[0279] In another embodiment, the distal end of the inner frame and the arm portion is compressed, and the loading section is driven by the operation control handle to move proximally to receive the distal end of the inner frame and at least the distal part of the arm portion. The catheter sheath is further driven by the operation control handle to move distally to receive the proximal end of the inner frame and the exposed part of the arm portion. In this embodiment, the compression of the inner frame and the arm portion can be achieved by a compression device or manually compression in a cold water bath. In one embodiment, the arm portion is arranged to avoid the loading section or is arranged on the outer periphery of the loading section, and the distal end of the catheter sheath is arranged to abut the axial direction of the loading section or to wrap around the proximal part of the loading section. In one embodiment, the distal movement of the catheter sheath is achieved by driving the catheter sheath to push the fixed seat distally relative to the operation control handle.

[0280] In the above two embodiments, the loading section has an avoiding opening, and in the process of receiving the distal end of the inner frame, the avoiding opening is first aligned with the arm portion in the circumferential direction. The method of circumferential alignment includes rotating the loading section in the circumferential direction by operating the control handle. Figures 46 to 63 The application also provides an operation control handle 3 connected to the control catheter assembly 4, which comprises:

[0281] The support body 3300 comprises two rigid strips 333 arranged side by side, and a guide channel 334 is defined between the two rigid strips 333.

[0282] The driving mechanism is configured with multiple sets, and at least two sets of the driving mechanism each comprises a transmission member 340 slidingly installed in the guide channel 334 and a driving sleeve 350 threadedly matched with the transmission member 340 and arranged in a sleeved manner on the outer periphery of the support body.

[0283] The support body adopts a two-rigid-strip structure, on the one hand, the diametrically opposite sides of the guide channel are through, facilitating the radial installation of the transmission member, and on the other hand, the axial direction of the guide channel is also through, meeting the movement requirement of the transmission member. Moreover, compared with the existing support body structure, the strip structure is more convenient to process and is not limited by materials, for example, the rigid strip 333 is a metal strip, effectively improving the structural strength of the support body.

[0284] In addition, if the number of components of the control mechanism increases or the operation is complicated, for example, the number of transmission members and driving sleeves increases, the rigid strip can be correspondingly lengthened in the axial direction to meet the installation requirement of the excess transmission members and driving sleeves, and the installation mode between each transmission member and the support body and between each driving sleeve and the support body is the same, realizing modular installation and not having to sacrifice the structural strength for the installation.

[0285] In one embodiment, the length of the two rigid strips 333 accounts for at least 75% of the total length of the operation control handle 3, wherein the length of each of the two rigid strips is the length of the axial direction of the two ends, and the total length of the operation control handle is the fully stretched state of the operation control handle. That is, starting from the distal end face of the first driving sleeve 351 and ending at the proximal end face of the force applying member 355 in the following embodiment.

[0286] In one embodiment, the rigid strips 333 are provided with a plurality of weight-reducing holes, which reduce the weight of the support body and the contact area between the support body and the transmission member, thereby reducing the friction and making the movement of the transmission member smoother.

[0287] In one embodiment, the distal ends of the rigid strips 333 extend into the telescopic assembly 38, for example, the distal ends of the rigid strips 333 extend close to the first head.

[0288] In another embodiment, the catheter assembly 4 comprises a first set and a second set of movable sleeves arranged from outside to inside, the control handle 3 comprises a first handle 3100 and a second handle 3200, the first handle 3100 is used to connect the first set, and the second handle 3200 is used to connect the second set, the first handle 3100 and the second handle 3200 each comprise a support body 3300, each support body 3300 comprises two rigid strips 333 arranged side by side, the first handle 3100 and the second handle 3200 can share the same support body (as shown in Figure 46 ), or the support bodies of the first handle 3100 and the second handle 3200 are not shared. The first handle 3100 and the second handle 3200 are away from each other and correspond to the fully extended state of the control handle when they are farthest apart.

[0289] In one embodiment, the control handle 3 comprises a mounting seat 360 fixedly connected with the two rigid strips 333, and the driving sleeve 350 is sleeved on the rigid strips 333 and rotationally matched with the mounting seat 360. The mounting seat 360 provides a mounting base for the driving sleeve and maintains the relative fixation between the two rigid strips. The present application also provides a delivery system, which comprises a catheter assembly loaded with an artificial implant at the distal end, a control handle connected to the proximal end of the catheter assembly to control the catheter assembly, and the catheter sheath 70 of the above-mentioned embodiments. The catheter assembly can be inserted into the tube of the catheter sheath through the hemostatic valve, and the specific structure of the catheter assembly and the control handle can adopt the prior art. Moreover, since the deformation section can assist in recovering the artificial implant after switching to the expanded state, the structure of the catheter assembly can be further simplified. For example, the outermost tube can be omitted relative to the conventional catheter assembly.

[0290] The catheter sheath of the present application can reach a relatively far surgical site, for example, the tube length extends to the ascending aorta, and a relatively long channel is constructed, which facilitates the delivery of the catheter assembly and the artificial implant.

[0291] Hereinafter, other embodiments are mainly provided for the structure of the lock and the base, and the working principle can be combined with the above-mentioned embodiments, and the proximal handle control can be combined with the conventional technology or the above-mentioned embodiments.

[0292] In one embodiment, another arrangement of the lock is provided, as shown in Figure 48The base 10 has a distal end 301 and a proximal end 302 opposite to each other, and an axial direction extending between the distal end 301 and the proximal end 302. The base 10 has a first cavity 103 inside. The proximal end of the base 10 has a first opening 1031 communicating with the first cavity 103. The outer peripheral surface of the base 10 has a second opening 1033 communicating with the first cavity 103.

[0293] like Figure 49 The pull wire 11 is passed through the first cavity 103, one end of the pull wire 11 (i.e., the control end 113) extends proximally out of the base 10 through the first opening 1031, and the other end of the pull wire 11, i.e., the free end 111, extends out of the base 10 through the second opening 1033 to connect to the artificial implant.

[0294] In this embodiment, refer to Figure 50a 、 Figure 50b The locking area 101 is located at the second opening. Along the circumference of the base 10 , a plurality of locking areas 101 are arranged at intervals, and the positioning portion 131 enters or moves out of each locking area 101 in sequence as the locking member 13 moves.

[0295] In one embodiment, if Figure 49 The control mechanism also includes a third shaft 25 fixedly connected to the base 10. The proximal end of the third shaft 25 extends and can be controlled by the control handle. The third shaft 25 can keep the base 10 relatively fixed in the circumferential direction, so that the positioning portion 131 can rotate relative to the base 10.

[0296] In one embodiment, a plurality of partitions are arranged circumferentially on the base 10, and adjacent partitions separate the second openings 1033. Therefore, a plurality of second openings 1033 are arranged circumferentially on the base 10, and the partitions are Figure 50a 、 Figure 50b The rib 1035 in the positioning portion 131 is arranged along the first direction (eg Figure 51 During the movement of the middle X), the free end 111 switches from the second state to the first state, and the locking hole 105 passes through the rib 1035 along the first direction. The locking hole 105 has a relative forward opening and a rear opening, wherein the forward opening faces the first direction.

[0297] In a preferred embodiment, all ribs 1035 (e.g., ribs 1035a and ribs 1035b) are provided with locking holes 105. These holes allow the positioning portion 131 to rotate through them sequentially and provide a certain degree of movement guidance. During the process of rotating the locking element into each locking hole, the head end 1313 eventually abuts against the side wall 1034 of one of the ribs 1035 or is inserted into the corresponding locking hole, thus acting as a position limiter.

[0298] When the positioning portion 131 is a multi-turn spiral, the opening position of the locking hole 105 of each rib 1035 is adapted to the positioning portion 131. There are one or more locking holes 105 on the same rib 1035. The multiple locking holes 105 are arranged in sequence along the extension direction of the rib 1035.

[0299] The side of the rib 1035 facing the first cavity 103 is the inner side, and the inner side of each rib 1035 is provided with a guide groove 1039 for the positioning portion 131 to extend. The axial through-hole of the guide groove 1039 allows the positioning portion 131 to rotate through, and the proximal side of the guide groove 1039 is open for the positioning portion 131 to be placed and positioned. After the lock member 13 is rotated, it is inserted into the first lock hole 105c (as shown in FIG. Figure 52a In one embodiment, the depth of the guide groove corresponding to each rib is ( Figure 52b The H) in the figure are different, satisfying the rotation guide of the spiral positioning portion 131.

[0300] See Figure 52a In one embodiment, one section of the rib 1035 along the axial direction is a bent section 1037 extending radially inward, and the locking hole 105 is located at the bent section 1037 corresponding to the rib 1035. The bent section 1037 is located at the distal end and forms a chamfered or rounded structure on the distal side of the base as a whole, which serves as a guide when the artificial implant is collapsed.

[0301] Taking into account the rotational characteristics of the lock element and the circumferential distribution of the pull wires, the positioning portion 131 is a rod-shaped rod, which can be straight or curved. There is only one rod and it mates with the free ends 111 of all the pull wires 11. This eliminates the axial dimensional changes of the control mechanism while retaining the original function of the lock element mate with the pull wires one by one.

[0302] In one embodiment, the base 10 defines a locking hole 105, the opening of which is circumferentially oriented toward the base 10. A positioning portion 131 has a curved shape and extends about the base axis. Positioning portion 131 is inserted into and removed from locking hole 105 as the locking element 13 rotates. This curve fully utilizes the circumferential space, maintaining the necessary length of the locking element, and enabling control of the free ends of all pull wires using the same locking element.

[0303] like Figure 53 At least a portion of the lock element 13 is a connecting portion 135 located in the first cavity 103. The control mechanism further includes a first shaft 21 that is in transmission engagement with the connecting portion 135 to drive the lock element 13 to rotate relative to the base 10. The proximal end of the first shaft 21 is connected to and controlled by the control handle.

[0304] In one embodiment, the pull wire 11 has a control end 113 opposite the free end 111, the control end 113 being movable relative to the base 10, and the control mechanism further comprises a second shaft 23 connected to the control end 113, the second shaft 23 being tubular and movably sleeved outside the first shaft 21. The second shaft 23 is moved to drive the pull wire 11 to gradually contract or gradually expand the artificial implant.

[0305] In some embodiments, the positioning portion 131 comprises at least an arc-shaped structure matched with the base, for example Figures 53 to 55 The positioning portion 131 is a spiral structure, and the spiral structure is at least one turn. For example, the spiral structure is a multi-turn structure, and each turn is arranged in an axial direction (circumferential direction of the base). The generatrix of the spiral structure can be a slant line (away from or close to the axis of the base) or a straight line. For example, when the generatrix is a straight line, the radial dimension can be avoided to be increased or the matching space between the connecting portion 135 and the first shaft 21 can be avoided to be reduced.

[0306] In the embodiment, the head end 1313 of the positioning portion 131 is matched with the base 10 and the pull wire, and the end 1311 of the positioning portion 131 is fixed to the connecting portion 135, for example, fixed to the outer periphery or the distal end of the connecting portion 135. The connecting manner can be that the end is directly welded, or the local overlapping is welded and fixed after the local overlapping.

[0307] The connecting portion 135 is tubular, and the inside of the connecting portion 135 is used for sleeving other components, for example, the first shaft 21. In order to improve the connection strength and avoid the extension of the components, the positioning portion 131 can be spirally arranged on the outer periphery of the connecting portion 135. The connecting portion 135 and the positioning portion 131 are located in the first cavity 103 and are welded and fixed relative to each other at a section close to the end 1311.

[0308] The connecting portion 135 is fixed to the distal end of the first shaft 21, or can be axially separated from the distal end of the first shaft 21.

[0309] For example Figures 53 to 55 In one embodiment, the positioning portion 131 is a multi-turn spiral structure, and there is an axial gap between adjacent turns. The inside space 1317 surrounded by the spiral structure, and at least a section of the pull wire 11 is a detour section 117. In the first state, the detour section 117 is located in the inside space 1317, and both ends of the detour section 117 extend out of the inside space 1317 through the corresponding axial gap. The detour section 117 and the positioning portion 131 form a force point (a first force point), and the free end 111 is sleeved into a turn of the positioning portion 131 adjacent to the first axial gap 1315b and serves as a second force point, so that the second shaft 23 acts on the artificial implant to contract.

[0310] The number of turns of the positioning portion 131 is at least one and a half turns or more than two turns, for example Figure 54a more than two turns, or for example Figure 54b approximately one and a half turns.

[0311] In the first state, the pull wire 11 extends from the control end 113 to the outside of the positioning portion 131, bends to the inside of the positioning portion 131 through the second axial gap 1315a, extends from the second axial gap 1315a to the first axial gap 1315b, and bends to the outside of the positioning portion 131 through the first axial gap from inside to outside. After passing through the artificial implant, the free end 111 is sleeved on the positioning portion 131. The detour segment 117 is between the first axial gap 1315b and the second axial gap 1315a. The part of the pull wire 11 extending from the control end 113 to the second axial gap 1315a is between the positioning portion 131 and the base 10, as far as possible from the first shaft 21, reducing the influence on the cooperation between the first shaft 21 and the connecting portion 135, and facilitating the fixed connection between the connecting portion 135 and the positioning portion 131.

[0312] In another embodiment, the application also provides a control mechanism having opposite distal and proximal ends and an axial direction extending between the proximal and distal ends, the control mechanism comprising:

[0313] an intervention component 24, comprising a first intervention component 241 and a second intervention component 242;

[0314] a transmission component 22, the distal end of which is fixedly connected to the first intervention component 241;

[0315] a control handle 3, connected to and controlling the proximal end of the transmission component 22;

[0316] a linkage structure, comprising two cooperating portions 271 selectively linked, one of the two cooperating portions being fixed to the second intervention component 242, and the other being fixed to the transmission component 22, and the linkage state of the two cooperating portions being switched during the movement of the transmission component 22.

[0317] In the linked state, the two cooperating portions drive the second intervention component 242 to rotate or move linearly, for example, when the transmission component 22 slides along the axial direction, the two cooperating portions enter or release the linked state; for example, Figure 56a when the two cooperating portions 271 are in the released linked state, the transmission component 22 slides along the axial direction to switch the two cooperating portions 271 to the linked state as shown in Figure 56b , and the transmission component 22 can drive the second intervention component 242 to rotate.

[0318] or when the transmission component 22 rotates, the two cooperating portions enter or release the linked state; for example, Figure 57a when the two cooperating portions 271 are in the released linked state, the transmission component 22 rotates to switch the two cooperating portions 271 to the linked state as shown in Figure 57b , and the transmission component 22 can drive the second intervention component 242 to slide.

[0319] The two mating parts are a linkage key and a linkage slot that can be axially slidably separated. When the linkage key is inserted into the linkage slot, they rotate in conjunction with each other. The two mating parts can also be a linkage key and a linkage slot that can be relatively rotatably separated. When the linkage key is inserted into the linkage slot, they axially link with each other. There are multiple linkage keys, one of which has a partially tubular shape. The multiple linkage keys are arranged along the circumference of the tubular portion, and accordingly, there are multiple linkage slots.

[0320] In the figure, along the axial direction, the first intervening component 241 is located on one side (proximal side) of the second intervening component 242. In certain initial or linkage states, the first intervening component 241 and the second intervening component 242 can also be partially nested with each other.

[0321] In combination with common application scenarios, the first intervention component and the second intervention component include the following independent components:

[0322] an inner shaft assembly 41 for an artificial implant (e.g., an artificial heart valve) before load release;

[0323] An outer sheath, which wraps around the artificial heart valve before release;

[0324] a base connected to the artificial heart valve before release and axially limiting each other;

[0325] a lock for restraining the artificial heart valve to the base before release;

[0326] The balloon body carries the artificial heart valve and can expand the artificial heart valve;

[0327] The pull wire is connected to the artificial heart valve and controls the release process of the artificial heart valve.

[0328] See Figures 58 to 60b In conjunction with the lock element 13 structure described above, in one embodiment, the lock element 13 serves as the second intervening component, and the first shaft 21 serves as the first intervening component. At least a portion of the lock element 13 comprises a connecting portion 135. The first shaft 21 engages with the connecting portion 135 to drive the lock element 13 relative to the base 10. The connecting portion 135 is tubular, and its wall includes a rotational linkage structure that engages with the distal end of the first shaft. When the first shaft 21 moves axially relative to the connecting portion 135, the rotational linkage structure disengages or engages. The connecting portion 135 is located within the base 10, facilitating radial coupling with the first shaft 21.

[0329] The rotary linkage structure includes two selectively linked matching parts, namely:

[0330] A linkage key 1352 is radially protruded from one of the connecting portion 135 and the first shaft 21;

[0331] The linkage groove 2111 is provided in the other one of the connecting portion 135 and the first shaft 21, and is open at the end face of the one in which it is provided. For example Figure 60a , The linkage groove 2111 is provided in the other one of the connecting portion 135 and the first shaft 21, and is open at the end face of the one in which it is provided. For example Figure 60b , the linkage groove 2111 is provided in the first shaft 21 and is open toward the distal end, and the linkage state is switched by sliding in the axial direction. The rotational linkage of the two is manifested in the circumferential direction, with the side wall of the linkage groove 2111 abutting against the side wall of the linkage key 1352 (as shown in Figure 61 ).

[0332] Preferably, as shown in Figure 62 , the linkage groove 2111 is provided with a flared structure 213 for guiding the insertion of the linkage key 1352. The linkage groove 2111 is provided at the distal end of the first shaft 21, in which, as shown in Figure 60a , Figure 60b and Figure 62 , the distal end of the first shaft 21 is fixed with a tube 40 extending from the base, the linkage key 1352 is sleeved and abuts against the outer periphery of the tube 40, maintaining the positioning between the lock 13 and the base 10, and facilitating the insertion of the linkage groove 2111.

[0333] In an embodiment, as shown in Figure 62 , the tube wall of the connecting portion 135 is partially deformed to form the linkage key 1352. An avoidance area 1353 is formed on the outside of the linkage key 1352. The avoidance area 1353 is present between the linkage key 1352 and the positioning portion 131, and the detour section 117 of the pull wire 11 can be placed in the avoidance area 1353, facilitating the threading of the pull wire 11.

[0334] The linkage key 1352 is formed in the following manner: as shown in Figure 58 , the tube wall of the connecting portion 135 is provided with a pair of cutouts 1355 adjacent to the proximal end face, and the portion between the same pair of cutouts 1355 is folded inward in the radial direction to form the linkage key 1352. The connecting portion 135 is a cylindrical structure, and the linkage key 1352 is a sheet. In an embodiment, the linkage key 1352 is distributed in 2-4 circumferential directions. For example Figure 58 , the linkage key 1352 is 2. In another embodiment, another structure of the lock is provided, and the handle portion can adopt other embodiments described herein, see Figures 63 to 67 , the present application provides a control mechanism of an artificial implant, comprising a base 10, a pull wire 11 and a lock 13, wherein the base 10 has opposite distal and proximal ends 32 and 31, and an axial direction extending between the distal and proximal ends 32 and 31, which are applicable to other components of the control mechanism and the control handle and delivery system of the following embodiments unless otherwise specified.

[0335] The base 10 is provided with a plurality of locking holes 105 which are axially staggered. The pull wire 11 has a free end 111 which can be threaded through or detached from the artificial implant 400, and is the end of the pull wire 11 which is first threaded through and last detached from the artificial implant 400, and can also be understood as the farthest end of the pull wire 11 when it is stretched out. The pull wire 11 also has a control end 113 opposite the free end 111, and can also be understood as the nearest end of the pull wire 11 when it is stretched out. The control end 113 can be directly fixed to the base 10, or extend controllably proximally. There is an area between adjacent locking holes 105 for the free end 111 of the pull wire 11 to combine with the locking piece 13. The locking piece 13 is rotationally matched with the base 10, and enters or moves out of the locking hole 105 in the rotation process to respectively lock and release (hereinafter referred to as release) the free end 111 of the pull wire 11.

[0336] Specifically, the free end 111 of the pull wire 11 has a first state (as shown in Figure 63 ) which is locked and limited by the locking piece 13 to the base 10, and a second state (as shown in Figure 64 ) which is released and un-limited by the locking piece 13. The locking piece 13 cooperates with the free end 111 of the pull wire 11 to switch the state of the free end 111. In the first state, the free end 111 is combined with the locking piece 13 and the locking piece 13 is matched with the base 10 to limit the pull wire 11 from being detached from the locking piece 13, at which time the free end 111 can be understood as being relatively fixed to the locking piece 13 or the base 10. In this state, the pull wire 11 is always connected to the artificial implant 400, and adjusts the expansion process (i.e. the degree of expansion) of the artificial implant according to the length of the pull wire 11 exposed outside the control mechanism, and controls the expansion / contraction speed of the artificial implant according to the change rate of the pull wire. If necessary, the pull wire 11 can also be used to retrieve the artificial implant, for example, in the first state, the control end 113 is operated to reduce the length exposed outside the control mechanism.

[0337] In the second state, the free end 111 is detached from the base 10, at which time the free end 111 can be understood as being released. After the pull wire 11 is released and detached from the artificial implant, the control end 113 is driven to move the pull wire 11 proximally to retrieve the pull wire 11, for example, to reduce the length exposed outside the base, and preferably to completely store it in the base. After the pull wire 11 is released, the mutual connection between the artificial implant and the control mechanism is accordingly released, and then the control mechanism as a whole can be withdrawn to the outside of the body, leaving the artificial implant in the predetermined position in the body.

[0338] Wherein the lock 13, base 10 and pull wire 11 are pre-assembled outside the body, the pull wire 11 is threaded through the base proximal end and then out of the base distal end or side wall to wrap around the artificial implant and then combined with the lock 13. For the combination of the pull wire 11 and the lock 13, the free end 111 of the pull wire 11 is combined with the lock 13 in the corresponding area of the base 10 in the first state, and then the lock 13 continues to rotate to enter the next lock hole 105, blocking the channel of the pull wire 11 from the lock 13.

[0339] In combination Figures 63 to 65 , the plurality of lock holes 105 of the base 10 of the embodiment are arranged in the axial direction, that is, the combination positions of the free ends 111 of the pull wires 11 and the base 10 are staggered in the axial direction, reducing the spatial interference between the pull wires 11, facilitating the assembly of the pull wire, base and lock, and the movement between the pull wires.

[0340] Wherein, the shape of the artificial implant 400 is generally a cylindrical structure, and the plurality of lock holes 105 are arranged in sequence along the circumference of the base, so that the pull wires 11 are arranged in the circumferential direction and connected to the positions of the artificial implant 400 in the circumferential direction, keeping the circumferential force of the artificial implant 400 uniform and keeping the lengths of the pull wires 11 substantially consistent, facilitating the uniform control of the lengths of all the pull wires 11 exposed outside the base. And expand the spatial distance between the pull wires 11, further facilitate assembly and reduce interference between each other. In an embodiment, the axial positions of the plurality of lock holes 105 are different, specifically, the plurality of lock holes 105 are arranged in a spiral line, the spiral line extends spirally around the base axis, and the rotation path of the lock 13 is subject to the lock hole 105 during rotation around the base axis, thereby sequentially entering each lock hole 105 and displacing in the axial direction of the base. The axial displacement can reduce or eliminate the axial protrusion of the lock 13 relative to the base 10. The spiral arrangement can enable the lock holes 105 at different positions in the circumferential direction to be arranged in the axial direction, reduce the spatial interference between the pull wires 11, optimize the overall meridian size, and further highlight the synergy of the base structure and the movement characteristics of the lock.

[0341] Referring to Figures 66 to 80 , the application also provides a control mechanism of an artificial implant, comprising a base 10, a pull wire 11 and a lock 13, the pull wire 11 and the lock 13 are referred to the foregoing embodiments, and the base 10 comprises a plurality of components fixed to each other, wherein two components form a lock hole 105 by surrounding the combination site. In this embodiment, the lock hole 105 is formed by the cooperation of the two components, and the two components can be independently machined and selected with appropriate materials, eliminating the conventional punching operation and reducing the overall machining difficulty of the base 10.

[0342] In one embodiment, the base 10 includes an outer sleeve 170 and an inner core 180 that are nested and fixed together, and the outer sleeve 170 and the inner core 180 together form a locking hole 105. It can be understood that the locking hole 105 is formed by the outer sleeve 170 and the inner core 180 cooperating with each other. After the outer sleeve 170 and the inner core 180 are assembled, a complete locking hole 105 is formed at the junction of the two.

[0343] The cross-sectional profile of the locking hole 105 is not strictly limited to being complete and uninterrupted, but at least it can keep the locking element 13 from being separated from the base 10 after the locking element 13 enters the locking hole 105 .

[0344] For example, the cross-sectional profile of the lock hole 105 is continuous, that is, the lock hole is closed in its own circumferential direction, a portion of the lock hole is formed in the inner core tube 180, and at least a portion is open, while the outer sleeve 170 closes the open portion. Of course, the processing and fitting errors between the inner core tube 180 and the outer sleeve 170 are negligible.

[0345] For another example, the cross-sectional profile of the locking hole 105 is discontinuous, a portion of the locking hole is formed in the inner core cylinder 180 and has an open portion, and the open portion is partially closed by the outer sleeve 170 .

[0346] The cross-sectional shape of the lock hole 105 is not strictly limited, as long as it is convenient for the lock member to enter and exit, and can be, for example, circular, elliptical, arched, or U-shaped. It can also be selected to correspond to the cross-sectional shape of the lock member. The outer sleeve 170 and the inner core 180 can each provide a portion of the edge of the lock hole 105, for example, substantially equally or one of them provides a majority.

[0347] For example, the cross-sectional shape of the lock hole 105 is a sealed U-shaped, the outer sleeve 170 provides the horizontal portion of the seal, and the inner core tube 180 provides the U-shaped portion; for another example, the cross-sectional shape of the lock hole 105 is an arch, the outer sleeve 170 provides the chord portion, and the inner core tube 180 provides the arc portion. The outer sleeve 170 and the inner core tube 180 can be nested as a whole or partially nested. The lock hole 105 can be radially between the outer sleeve 170 and the inner core tube 180, or it can be a step structure with an axial direction (or a certain angle) between the outer sleeve 170 and the inner core tube 180, and the lock hole 105 is located on the axial step surface.

[0348] For example Figures 68 to 73 A portion of the inner core tube 180 is located outside the outer sleeve 170 and radially turned outward to form a step structure. The turned-out portion and the end face of the outer sleeve 170 are axially opposed to each other, and the locking hole 105 is located at the opposing portion.

[0349] For example Figure 79 and Figure 80 The step structure is located on the inner wall of the outer sleeve 170, and the end face or the outer periphery of the inner core tube 180 (also with a step structure) is axially opposed, and the lock hole 105 is located at the opposing portion.

[0350] With reference to the drawings Figure 72 In one embodiment, the control mechanism further comprises three shafts, namely a first shaft 21, a second shaft 23 and a third shaft 25, which are sequentially sleeved from inside to outside; the base 10 is connected to the distal end of the third shaft 25, the pull wire 11 is connected to the distal end of the second shaft 23, and the locking piece 13 is connected to the distal end of the first shaft 21. The base 10 is axially penetrated along its own axis and forms a first cavity 181 inside itself, and the first shaft 21 extends to the distal end of the base 10 through the first cavity 181, for example, further extends out of the distal end of the base 10.

[0351] The proximal end side of the base 10 has a first opening 186 communicating with the first cavity 181, and the outer peripheral surface (i.e. the circumferential side wall) of the base 10 is provided with a second opening 171 communicating with the first cavity 181. One end (i.e. the control end 113) of the pull wire 11 extends out of the base 10 towards the proximal end through the first opening 186, and the other end (i.e. the free end 111) of the pull wire 11 extends out of the base 10 through the second opening 171 for connecting to the artificial implant.

[0352] With reference to the drawings Figures 66 to 85 The locking holes 105 are multiple and each locking hole 105 extends along a spiral line direction, and the locking piece 13 is sequentially inserted into or sequentially separated from each locking hole 105. In one embodiment, compared with the second opening 171, the intersection is understood as that the second opening 171 extends radially along the base to form a first passage, and the locking hole 105 extends along the spiral line direction to form a second passage, and the two passages intersect and have an intersection part (i.e. the spiral line intersects the second opening 171). It can also be understood that all the locking holes 105 are directly or indirectly communicated with each other through the second opening 171. The extension path of the pull wire 11 passes through the intersection part, and the locking piece 13 enters or exits the locking hole 105 at the intersection part to combine with the pull wire 11.

[0353] In combination with the specific structure of the base 10, the cross-sectional profile of the locking hole 105 at the rest position of the base 10 except the second opening 171 can be considered as circumferentially closed (i.e. a complete locking hole), and the cross-sectional profile of the locking hole 105 at the second opening (or the intersection part) is incomplete, at this time the locking hole 105 has an open mouth, and the locking piece 13 passes through the open mouth during rotation to enter or exit the complete locking hole 105.

[0354] As Figure 74 The second opening 171 of the inner core barrel 180 can be provided with a flared structure radially outward, which is convenient for loading the free end 111 of the pull wire 11 and also facilitates cooperation and guiding tool operation.

[0355] In an embodiment, the inner core 180 is an axial through structure, and itself internally as a first cavity 181. According to the assembly relationship between the inner core 180 and the outer sleeve 170, the outer wall of the inner core 180 and the side wall of the outer sleeve 170 are provided with second openings 171. The opening sizes of the respective second openings 171 are not required to be the same, and only need to ensure that the pull wire 11 can pass through. The pull wire 11 is a plurality of pull wires, and the respective second openings 171 are circumferentially spaced apart and arranged in a plurality. The opening direction of the lock hole 105 is the circumferential direction of the base. The free end 111 of the pull wire 11 extends out of the base 10 through the corresponding second opening 171 in the first state, passes through the artificial implant 400, and returns to the same second opening 171 or the circumferentially adjacent second opening 171. And as Figures 72 to 78 The inner wall of the outer sleeve 170 and / or the outer wall of the inner core 180 is provided with a spiral groove 182 for providing the lock hole 105, and the spiral groove 182 intersects the second opening 171. The outer circumferential surface of the inner core 180 is provided with a spiral groove 182, and the spiral groove 182 provides the aforementioned spiral line. The spiral groove 182 has a radially outwardly directed notch 183. The region where the outer sleeve 170 cooperates with the inner core 180 is a straight cylinder structure. After the outer sleeve 170 and the inner core 180 are assembled, the outer sleeve 170 partially encloses the notch 183 to form a complete lock hole 105, which is used to define the rotation path of the lock piece 13 and avoid the lock piece 13 from deviating during rotation. The cross-sectional shape of the spiral groove 182 refers to the cross-sectional shape of the aforementioned lock hole 105, such as a U-shaped or arc-shaped arc portion. For the small-sized base 10, the above-mentioned structure design facilitates the machining of the outer sleeve 170 and the inner core 180. The materials of the two can be metal or plastic, for example, the outer sleeve 170 is a tubular structure and is machined from a metal pipe, and the inner core 180 is injection molded from plastic. The size of the second opening of the corresponding inner core 180 is smaller than that of the outer sleeve 170. The size of the second opening includes but is not limited to the length in the axial direction of the base and the width extending around the axial direction of the base. In addition, compared with the existing punching machining method, the machining precision of the spiral groove 182 is improved, and the rotation smoothness of the lock piece 13 is improved accordingly.

[0356] In an embodiment, the proximal end side of the outer sleeve 170 is an extension segment 172 that extends beyond the inner core 180. The extension segment 172 is used to connect the third shaft 25 extending towards the proximal end. The outer sleeve 170 and the inner core 180 are provided with a positioning structure that cooperates with each other to keep the two relatively fixed. In combination with the drawings, the positioning structure includes a positioning groove 184 arranged on the outside of the inner core 180, and a positioning block 174 arranged on the inner wall of the outer sleeve 170 and embedded in the positioning groove 184. The positioning block 174 is a flange punched from the side wall of the outer sleeve 170.

[0357] The outer sleeve 170 is a tubular structure, and the third shaft 25 is a pipe. The third shaft 25 and the extension section 172 are connected to each other by, for example, fusion or adhesion. In an embodiment, the side wall of the extension section 172 has a connecting hole 173, and an adhesive or the like can be added to the connecting hole 173 to improve the connecting strength of the two and avoid the increase of the radial dimension of the two after connection.

[0358] In an embodiment, the helical line is a cylindrical helical line, a conical helical line or a partially conical helical line. Preferably, the helical line is a cylindrical helical line, and the outer sleeve 170 and the inner core barrel 180 are substantially straight.

[0359] In an embodiment, the helical groove 182 extends to the distal end face of the inner core barrel 180, and the helical groove 182 has a guide slope 185 at the opening of the distal end face of the inner core barrel 180 to guide the lock piece 13 to be assembled into the helical groove 182.

[0360] Referring to Figures 81 to 85 In an embodiment, the lock piece 13 has a positioning portion 131 that enters or exits the lock hole 105 during rotation. The positioning portion 131 is a helical structure matched with the helical line to improve the rotation smoothness. The helical structure has at least one turn, for example, the helical structure has multiple turns, such as 4-5 turns in the figure, and the turns are arranged along the base axis. The extension path of the helical structure is a cylindrical helix, a conical helix or a partially conical helix. The connecting portion 134 movably sheaths the distal end of the first shaft 21 and can be axially separated from the distal end of the first shaft 21. Specifically, the connecting portion 134 is axially movable relative to the first shaft 21. In actual use, the first shaft 21 slides along the base axis and separates from or combines with the connecting portion 134. After the first shaft 21 is axially combined with the connecting portion 134, the first shaft 21 is driven to rotate to drive the connecting portion 134 to rotate, thereby driving the lock piece 13 to enter or exit the lock hole 105. After the connecting portion 134 is axially separated from the distal end of the first shaft 21, the control of the first shaft 21 on the lock piece 13 is released. The cooperation and control relationship between the first shaft 21 and the lock piece 13 are described in the following embodiments.

[0361] The lock piece 13 is divided into an insertion direction and an exit direction in the rotation direction. In an embodiment, a limiting mechanism is arranged between the lock piece 13 and the base 10 to limit the rotation of the lock piece 13 in the insertion direction. Specifically, when the limiting mechanism acts during the rotation of the lock piece 13, the lock piece 13 is limited to continue to rotate in the insertion direction.

[0362] In the figure, the limiting mechanism includes a first end face arranged at the proximal end of the connecting portion and a second end face arranged at the distal end of the base 10 and abutting against the first end face. Specifically, the second end face is arranged on the inner core barrel 180.

[0363] For another example, the limiting mechanism includes a head end face provided on the positioning portion 131 and a third end face provided on the base 10 and abutting against the head end face. Specifically, the third end face is provided on the side wall of the second opening 171 of the inner core barrel 180 .

[0364] In one embodiment, the connecting portion 134 is a tubular shape extending in equal diameter or radially expanding at least at its proximal end, and its proximal end is fixedly connected to the positioning portion 131. The following is an explanation of the assembly process of the pull wire 11, the base 10 and the locking member 13 in vitro:

[0365] First, the free end 111 of the pull wire 11 enters the first cavity 181 through the first opening 186, then passes through the inner core tube 180 and the second opening 171 of the outer sleeve 170, extends out of the base, passes through the artificial implant 400, and then is rewound back to the corresponding second opening 171. At the same time, the locking member 13 is rotated to insert into the corresponding locking hole and engage the corresponding pull wire 11. The length of the pull wire 11 exposed outside the base 10 is then retracted to pull the artificial implant 400 radially toward the base 10.

[0366] In one embodiment, the artificial implant 400 is a cylindrical structure with a corresponding circumference, and a plurality of pull wires 11 are provided. The control end 113 of each pull wire 11 can be controlled independently or moved synchronously. The positions where each pull wire 11 interacts with the artificial implant 400 are arranged at intervals along the circumference of the artificial implant 400, which can improve the synchronization of the contraction and expansion of the artificial implant 400. For example Figure 67 There are three pull wires 11, which interact with the artificial implant 400 at three locations and are arranged at intervals around the circumference of the artificial implant.

[0367] The base 10 has a locking area, which is the area where the pull wire 11 is combined with the locking member 13. For example, the area where the second opening 171 of the aforementioned base 10 is located. There are multiple locking areas, and the number can be the same as the number of pull wires 11 or twice the number of pull wires 11. In the first state, the free end 111 of the pull wire 11 extends out of the base 10 through the current locking area, and the free end 111 after passing through the artificial implant 400 returns to the same locking area, or returns to the adjacent locking area. The free end 111 of each pull wire 11 corresponds to one or two locking areas in the first state to avoid interference between the pull wires 11.

[0368] The control end 113 of each pull wire 11 can be directly extended to the control handle independently, or it can be indirectly transmitted through an intermediate piece to reduce the risk of multiple pull wires 11 being intertwined with each other, such as Figure 72 As shown, the second shaft 23 is a tubular structure and serves as an intermediate piece, and the control end 113 of each pull wire 11 is connected to the second shaft 23 .

[0369] See Figures 85 to 88In one embodiment, the lock piece 13 has at least one connecting portion 134, and the first shaft 21 selectively cooperates with the connecting portion 134 through a linkage assembly to drive the lock piece 13 to rotate relative to the base 10. The two cooperating portions are a linkage key and a linkage slot. The linkage key 1341 is radially protruded from one of the connecting portion 134 and the first shaft 21. The linkage slot 2111 is cooperated with the linkage key 1341, and is provided on the other one of the connecting portion 134 and the first shaft 21. The linkage key 1341 and the linkage slot 2111 are both open to the end face of the one in which they are provided. In the illustration, the linkage key 1341 is provided on the distal end of the connecting portion 134, and the linkage slot 2111 is provided on the loading segment 211. The linkage between the two is in the circumferential direction, and the sidewall of the linkage slot 2111 abuts against the sidewall of the linkage key 1341. The connecting portion 134 is in a cylindrical structure, and the linkage key 1341 is in a sheet shape. In one embodiment, the linkage key 1341 is distributed in 2-4 circumferential positions, for example, the linkage key 1341 is in 2 circumferential positions.

[0370] Preferably, the slot of the linkage slot 2111 is provided with a flared structure to guide the insertion of the linkage key 1341, and the distal end face of the linkage key 1341 is provided with a tapered structure to guide the insertion into the slot, so as to facilitate the combination of the linkage key 1341 and the linkage slot 2111.

[0371] The loading segment 211 is nested with the connecting portion 134 in the combined state, and the inner periphery of the loading segment 211 is provided with a support 212, which is fixed to the distal end of the first shaft 21. One of the cooperating portions (i.e. the linkage slot) is provided on the support 212. The support 212 and the loading segment 211 are provided with a limiting structure to limit the axial separation of the two.

[0372] The loading segment 211 has a guide head 215 at the distal end and connected to the first shaft 21, and a loading portion 216 connected to the guide head 215 to accommodate the distal end of the artificial implant. The support 212 is provided in the guide head 215.

[0373] In one embodiment, the loading segment 211 and the lock piece 13 have an axial gap L1 in the axial direction for the connecting portion to move distally during the rotation unlocking process. Similarly, the proximal end face of the guide head is distanced from the positioning portion 131 by the same axial gap L1 as described above. The axial gap L1 is greater than the movement amount of the distal movement of the lock piece 13.

[0374] Referring to Figure 89An embodiment of the present application also provides a method for loading an artificial implant based on a wire control mode, comprising: providing the control mechanism of the aforementioned embodiment, wherein the free end of the pull wire passes through the proximal end of the artificial implant, and is combined with and bound to the base by the locking piece; the pull wire has a control end opposite to the free end, and the control end is moved to gradually contract the part of the pull wire exposed outside the base and drive the proximal end of the artificial implant to deform radially; and a sheath tube is provided, and the sheath tube is moved relative to the artificial implant from the proximal end to the distal end along the outer periphery of the artificial implant until the sheath tube completely wraps the artificial implant. The specific operation is performed in vitro, the free end of the pull wire is first passed through the proximal end (for example, an eyelet) of the artificial implant, and then the free end is guided and extended into the locking area of the base by a device (for example, a wire holding device 500, the distal end of which is provided with two fork arms 522 arranged side by side). The first shaft is driven to move towards the proximal end to complete the combination with the locking piece, and at this time, the loading segment is located radially inside the artificial implant. The first shaft is then driven to rotate, thereby driving the locking piece to rotate through the free end and into the locking hole of the base, to complete the binding of the pull wire. The first shaft and the loading segment are pushed towards the distal end until the loading segment exits the artificial implant, and the control end of the pull wire is driven to move towards the proximal end to compress the proximal end of the artificial implant.

[0375] The distal end of the artificial implant (the distal end of the inner frame) is compressed by a device (for example, a compression device), the loading segment is driven to move towards the proximal end and wrap the distal end of the inner frame, and then the relative movement between the artificial implant and the sheath tube is realized, for example, the other components outside the sheath tube are driven to move towards the proximal end relative to the sheath tube, or the sheath tube is pushed towards the distal end until the sheath tube completely wraps the artificial implant.

[0376] The pull wire, the artificial implant and the control mechanism are pre-assembled, and an embodiment of the present application also provides a method for pre-assembling an artificial implant based on a wire control mode, comprising: providing the control mechanism of any of the aforementioned embodiments, wherein the free end of the pull wire passes through the proximal end of the artificial implant; as shown in FIGS. 56 and 57, the free end 111 of the pull wire 11 is provided with a wire loop and has two support points 118, which can be supported by the two fork arms 522, and the installation segment 119 is arranged between the two support points 118, the installation segment 119 is arranged in the locking area of the base 10, so that the wire loop is arranged on the movement path of the locking piece 13, and this operation can be completed by using the wire holding device 500; and the locking piece 13 is driven to rotate and move along the movement path thereof to pass through the wire loop and then be inserted into the locking hole of the base to bind the free end, and this operation is referred to the combination step of the pull wire and the locking piece in the aforementioned artificial implant loading method.

[0377] Any technical features in the above embodiments can be combined, and for the sake of brevity, not all possible combinations are described above, and it is understood that the scope of the present disclosure encompasses all possible combinations. When technical features in different embodiments are embodied in the same drawing, it can be considered that the drawing discloses a combination of the embodiments involved.

[0378] The above embodiments only express several implementation manners of the present application, and the description is relatively 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, a number of modifications and improvements can be made, which are within the protection scope of the present application.

Claims

1. A control mechanism for an artificial implant, characterized in that: include: The base is provided with a keyhole; a pull wire having a free end that can be threaded around or detached from the artificial implant; a locking member, rotatably engaged with the base, wherein the locking member enters or moves out of the locking hole during rotation to lock or release the free end of the pull wire; The base is provided with a plurality of locking holes, which are arranged along a spiral line. The locking element has an axial displacement during the rotation process and enters each locking hole in sequence.

2. The control mechanism of the artificial implant according to claim 1, characterized in that: The free end of the pull wire has a first state in which it is restricted to the base and a second state in which the restriction is released, the free end has a loop, and a portion of the locking element is a positioning portion having a spiral structure; When the free end is in a first state, the positioning portion penetrates the ring, and when the free end is in a second state, the positioning portion withdraws the ring.

3. The control mechanism of the artificial implant according to claim 1, characterized in that: The locking element is generally located at the distal end of the base.

4. The control mechanism of the artificial implant according to claim 1, wherein: The base comprises an outer sleeve and an inner core sleeve which are fixedly nested inside and outside, and the locking hole is provided between the outer sleeve and the inner core sleeve in radial direction.

5. The control mechanism of the artificial implant according to claim 4, characterized in that: The base has a first cavity inside, and the inner core tube is an axially through structure to provide the first cavity; The proximal side of the base has a first opening connected to the first cavity, and the outer peripheral surface of the base has a second opening connected to the first cavity. The base is provided with a plurality of lock holes, and the plurality of lock holes are arranged along a spiral line, and the spiral line intersects at the second opening. All the lock holes are directly or indirectly connected to each other through the second opening.

6. The control mechanism of the artificial implant according to claim 5, characterized in that: The inner wall of the outer sleeve and / or the outer wall of the inner core sleeve is provided with a spiral groove for providing the lock hole, and the spiral groove intersects with the second opening.

7. A method for pre-installing an artificial implant based on a wire control method, characterized in that: include: There is provided a control mechanism according to any one of claims 1 to 6, wherein the free end of the pull wire passes through the proximal end of the artificial implant; The free end of the pull wire has a wire loop and two support points, and a mounting section is located between the two support points. The mounting section is placed in the base so that the wire is placed around the movement path of the locking element. The locking element is driven to rotate and move along its own movement path to pass through the wire loop and then inserted into the locking hole of the base to bind the free end.

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