Control mechanism, locking mechanism and preassembling method of artificial implant

Abstract

The invention discloses a control mechanism, a locking mechanism, a loading method and a preassembling method of an artificial implant. The control mechanism of the artificial implant comprises a base, a stay wire and a lock piece, wherein a lock hole is formed in the base; the stay wire is provided with a free end which can be wound or separated from the artificial implant; and the locking piece is in running fit with the base so as to lock the free end of the stay wire. After the control mechanism is optimized, the control mechanism can be matched with each other to realize the control of the in-vivo expansion, release or recovery process of the artificial implant, and is more suitable for in-vivo work compared with the existing structure.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a control mechanism, a locking mechanism and a pre-installation method of an artificial implant. Background Art

[0002] With the development of medical conditions, artificial implants have been used to treat heart valve disorders. 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 interventional technology, a compressed, loaded artificial implant is installed in the distal portion of a catheter assembly and delivered to a predetermined location, and the catheter assembly is withdrawn from the body after the artificial implant is radially expanded and released.

[0004] Regarding the connection between the artificial implant and the catheter assembly, the prior art can adopt a direct snap-fit ​​or wire control method. The wire control method utilizes a flexible member to constrain the artificial implant to the distal end of the catheter assembly and lock the flexible member to maintain the compression state of the artificial implant. When it is necessary to allow the release of the artificial implant, the lock 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. However, the prior control method and control structure for the flexible member still need to be improved. Summary of the invention

[0005] In order to better utilize the characteristics of the wire control method and further improve its control structure and operational flexibility, the present application provides a control mechanism for an artificial implant, including:

[0006] The base is provided with a lock hole;

[0007] A pull wire having a free end that can be passed around or detached from the artificial implant;

[0008] The locking element is rotatably matched with the base, and the locking element enters or moves 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 of being restricted to the base and a second state of releasing the restriction, the free end has a loop, and a part of the locking element is a positioning portion having a spiral structure;

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

[0011] Optionally, the locking element is entirely located at the distal end of the base.

[0012] Optionally, 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 turn.

[0013] Optionally, the base includes an outer sleeve and an inner core sleeve which are nested and fixed inside and outside, and the locking hole is provided 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 tube is an axially through structure to provide the first cavity;

[0015] The proximal side of the base has a first opening connected to the first cavity, 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, the plurality of lock holes are arranged along a spiral line, the spiral line intersects at the second opening, and all the lock holes are directly or indirectly connected to 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 hole, and the spiral groove intersects at the second opening.

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

[0018] A first shaft, a loading section is fixed at the distal end thereof, the loading section is open toward the proximal end and is used to accommodate the distal end portion of the artificial implant;

[0019] A pull wire having a free end, the free end being capable of being passed around or detached from the artificial implant;

[0020] A third shaft, the sliding sleeve of which is arranged outside the first shaft;

[0021] A locking assembly, wherein the artificial implant is bound to the locking assembly by the pull wire during loading, the locking assembly comprising a locking element and a base fixed to the third axis, the locking element and the base having:

[0022] A mutually cooperating locking state restricts the pull wire from being separated from the artificial implant;

[0023] Release the lock state of the mating to allow the pull wire to be separated from the artificial implant;

[0024] A linkage assembly, acting between the first shaft and the locking element, so that the two are selectively linked;

[0025] In the unlocked state, the lock element is rotatably sleeved on the outer periphery of the first shaft. In the locked state, the lock element 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 includes two matching parts, one of which is connected to the loading section, and the other is connected to the locking element, and the loading section can move axially to make the two matching parts linked or disengaged;

[0027] The two matching parts are a linkage key and a linkage groove that can be axially slidably separated, and the linkage key is rotationally linked with each other when inserted into the linkage groove.

[0028] The present application also provides a method for pre-installing an artificial implant based on a wire control method, comprising:

[0029] Providing the control mechanism described in the present application, 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 loop and two supporting points, and a mounting section is between the two supporting points. The mounting section is placed in the base so that the wire is surrounded and placed in the movement path of the locking element;

[0031] 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.

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

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

[0034] Figure 1b for Figure 1a A schematic diagram of the structure of the pull wire disengaging the lock member in the control mechanism;

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

[0036] Figure 2b for Figure 2a A schematic diagram of the structure of the pull wire disengaging the lock member in the middle control mechanism;

[0037] Figure 3 This is a schematic diagram of a control structure with three pull wires in one embodiment of the present application;

[0038] Figure 4 It is a schematic diagram of each pull wire connected to the second shaft in the control structure of an embodiment of the present application;

[0039] Figure 5 A schematic diagram of the structure of a stent for an artificial implant according to an embodiment of the present application;

[0040] Figure 6a to Figure 6c They are schematic diagrams of the gradually closing of the 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 It is a schematic diagram of the structure of the pull-wire limiting artificial implant in the existing control mechanism;

[0043] Fig. 9 for Figure 8 A 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] Fig.10 This is a schematic diagram of the structure of a conveying system according to an embodiment of the present application;

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

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

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

[0048] Fig.13b for Fig.13a A partial structural view of the distal end of the middle second axis;

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

[0050] Fig.15 for Fig.14 Partial cross-sectional view of the base in the middle BB direction;

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

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

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

[0054] Figure 18a to Figure 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] Fig.20aThis is a structural schematic diagram of a pull wire in a first state according to an embodiment of the present application;

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

[0057] Figure 21a to Figure 21c They are schematic diagrams of the structure in which the pull wire of an embodiment is sequentially combined with each locking element;

[0058] Fig. 22 A front view of a base according to an embodiment of the present application;

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

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

[0061] Fig.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 Fig.24a Structural view of the middle lock;

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

[0064] Fig.25a This is a structural view of the lock and the base in another embodiment of the present application;

[0065] Fig.25b for Fig.25a Exploded view of;

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

[0067] Fig.27a A roadmap for the convergence of artificial implants in the prior art;

[0068] Figure 27b A schematic diagram of a conventional artificial implant after it has been folded up;

[0069] Fig.28 A folding roadmap for the artificial implant of the present application;

[0070] Fig.29 This is a front view of a control mechanism in an embodiment of the present application in which a pull line pulls the proximal side of an artificial implant to radially retract;

[0071] Fig.30aThis is a structural view of the control mechanism of one embodiment of the present application after the loading section is withdrawn and the locking element is engaged;

[0072] Fig.30b for Fig.30a Front view of the central control mechanism (with the cable removed for easier viewing);

[0073] Fig.31 A half-section view of a control mechanism according to an embodiment of the present application after the loading section and the locking element are matched;

[0074] Fig.32 A structural view of a loading section in a control mechanism according to an embodiment of the present application;

[0075] Fig.33 for Fig.32 Exploded view of the mid-loading section;

[0076] Fig.34a for Fig.33 Exploded view of the middle support;

[0077] Fig.34b is a half-section view of the support member;

[0078] Fig.35 A cross-sectional view of a loading section away from a base in a control mechanism according to an embodiment of the present application;

[0079] Fig.36a It is a partial structural schematic diagram of a loading section in a control mechanism of an embodiment of the present application when loading an artificial implant;

[0080] Fig.36b This is a schematic diagram of the radial relationship between the loading section and the artificial implant arm in the control mechanism of another embodiment of the present application;

[0081] Fig.36c This is a schematic diagram of the radial relationship between the loading section, the artificial implant and the catheter sheath in the control mechanism of an embodiment of the present application;

[0082] Fig.37 This is a structural view of an artificial implant according to an embodiment of the present application (the valve leaflets, skirt and other structures are omitted in the figure);

[0083] Fig.38 This is a front view of an artificial implant according to an embodiment of the present application (the valve leaflets, skirt and other structures are omitted in the figure);

[0084] Fig.39 A structural diagram of a conveying system according to an embodiment of the present application;

[0085] Fig.40 This is a structural view of a catheter sheath according to an embodiment of the present application;

[0086] Fig.41aThis is a schematic diagram of the structure of a control mechanism in one embodiment of the present application when wrapping and restraining an artificial implant;

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

[0088] Figure 41c to Figure 41e 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 It is a structural schematic diagram of the two matching parts in the control mechanism of the present application cooperating with each other and releasing the pulling wire;

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

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

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

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

[0094] Fig.45 for Fig.44 A schematic diagram of the structure in which the middle push-up driving mechanism drives the telescopic assembly to move toward the far end;

[0095] Fig.46 This is a structural view of a control handle according to an embodiment of the present application;

[0096] Fig.47 for Fig.46 Exploded view of;

[0097] Fig.48 This is a schematic diagram of the structure of the base in the control mechanism of this application;

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

[0099] Fig.50a , Fig.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] Fig.51 This is a schematic diagram of the structure of the lock and the base in the control mechanism of the present application;

[0101] Fig.52aThis is a schematic diagram of the process of inserting a lock element into a lock hole in the control mechanism of the present application;

[0102] Fig.52b It is a partial structural schematic diagram of the base in the control mechanism of the present application;

[0103] Fig.53 A half-section schematic diagram of a wire control end of a base portion of a control mechanism of the present application;

[0104] Fig.54a , Fig.54b This is a schematic diagram of the lock structure in the control mechanism of this application;

[0105] Fig.55 A schematic diagram of the path of the pull wire at the lock element in the control mechanism of the present application;

[0106] Fig.56a , Fig.56b A schematic diagram of the linkage of a control mechanism according to an embodiment of the present application;

[0107] Fig.57a , Fig.57b A schematic diagram of the linkage of a control mechanism of another embodiment of the present application;

[0108] Fig.58 This is a schematic diagram of the structure of the connection part of the lock element in the control mechanism of the present application;

[0109] Fig.59 It is a schematic diagram of a part of the structure at the far end of the first axis in the control mechanism of the present application;

[0110] Figure 60a-60b A half-section schematic diagram of the separation and combination of the first shaft and the connecting part in the control mechanism of the present application;

[0111] Fig.61 It is a schematic diagram of the first shaft in the control mechanism of the present application rotating after being combined with the connecting part;

[0112] Fig.62 A cross-sectional view of the base of the control mechanism of the present application;

[0113] Fig.63 This is a structural view of a control mechanism (locking element combined with a pull wire) according to an embodiment of the present application;

[0114] Fig.64 for Fig.63 Structural view of the middle lock and the pull wire when separated;

[0115] Fig.65 This is a schematic diagram of the assembly between the lock, the base and the pull wire according to an embodiment of the present application;

[0116] Fig.66This is a schematic diagram of the structure of a conveying system according to an embodiment of the present application;

[0117] Fig.67 for Fig.66 Middle A enlarged view;

[0118] Fig.68 for Fig.67 A partial schematic diagram after the artificial implant is removed;

[0119] Fig.69 for Fig.68 The enlarged schematic diagram of the middle C part after the pull line is combined;

[0120] Fig.70 An exploded view of a lock and a base according to an embodiment of the present application;

[0121] Fig.71 This is a front view of a lock and a base according to an embodiment of the present application;

[0122] Fig.72 for Fig.71 Partial cross-sectional view along the EE direction;

[0123] Fig.73 for Fig.72 Enlarged view of middle F part;

[0124] Fig.74 for Fig.72 Cross-sectional view in the middle DD direction;

[0125] Fig.75 for Fig.70 A schematic diagram of the structure of the middle and outer sleeves;

[0126] Fig.76 for Fig.70 A schematic diagram of the structure of the middle inner core tube;

[0127] Fig.77 for Fig.76 The front view of the middle inner core tube;

[0128] Fig.78 for Fig.77 Cross-sectional view of the middle inner core tube in the GG direction;

[0129] Fig.79 A schematic structural diagram of a base according to another embodiment of the present application;

[0130] Fig.80 A schematic structural diagram of a base according to another embodiment of the present application;

[0131] Fig.81 and Fig.82 It is a schematic diagram of the structure when the lock is combined with the pull wire and passes through the lock hole in sequence;

[0132] Fig.83 This is a schematic diagram of the structure of the lock element and the inner core cylinder in the early stage of assembly of an embodiment of the present application (the outer sleeve is removed for easy observation);

[0133] Fig.84 for Fig.83 A schematic diagram of the structure from another perspective;

[0134] Fig.85 for Fig.83 A schematic diagram of the structure after the middle lock piece and the inner core tube are assembled;

[0135] Fig.86 This is a schematic diagram of the structure when the loading section and the locking element are separated according to an embodiment of the present application;

[0136] Fig.87 for Fig.86 A schematic diagram of the structure when the middle loading section and the locking member are combined;

[0137] Fig.88 This is a schematic structural diagram of a support member in a loading section according to an embodiment of the present application;

[0138] Fig.89 It is a schematic diagram of the principles of a loading method and a pre-installation method in an embodiment of the present application.

[0139] 10. base; 101. locking area; 101a. locking area; 102. ribs; 102a. ribs; 102b. ribs; 1021. bending section; 1022. avoidance area; 103. first cavity; 1031. first opening; 1033. second opening; 1034. side wall; 1035. ribs; 1035a. ribs; 1035b. ribs; 1037. bending section; 1039. guide groove; 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 line; 112, forward section; 111, free end; 111a, free end; 111b, free end; 111c, free end; 113, control end; 114, return section; 115a, ring; 116, middle section; 117, detour section; 118, support point; 119, installation section; 13, lock; 131, positioning part; 1311, end; 13110, end; 1313, head end; 13130, head end; 1315b, first axial gap; 1315a, second axial gap; 1317, internal space; 134, connecting part; 1341, linkage key; 135 , connecting part; 1351, connecting section; 1352, linkage key; 1353, avoidance area; 1354, closing structure; 1355, incision; 170, outer sleeve; 171, second opening; 172, extension section; 173, connecting hole; 174, positioning block; 180, inner core tube; 181, first cavity; 182, spiral groove; 183, notch; 184, positioning groove; 185, guiding slope; 186, first opening;

[0140] 21. first axis; 211. loading section; 2111. linkage groove; 212. support member; 213. flaring structure; 2130. outer cylinder; 2131. positioning piece; 2140. inner cylinder; 2141. linkage groove; 2142. flaring structure; 215. guide head; 216. loading part; 217. avoidance; 22. transmission part; 23. second axis; 231. connecting hole; 232. notch; 233. connecting arm; 234. deformation hole; 24. intervention part; 241. first intervention part; 242. second intervention part; 25. third axis; 27. extension tube; 271. matching 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. Drive sleeve; 351. First drive sleeve; 355. Force-applying component; 360. Mounting seat; 38. Telescopic assembly; 381. First stage; 382. Intermediate stage; 383. Final stage; 384. Abutment member; 39. Push-up drive mechanism;

[0142] 4. Catheter assembly; 40. Pipe fitting; 400. Artificial implant; 430. Bending sheath; 500. Wire holding device; 51. Tube body; 510. Main section; 520. Deformation section; 522. Fork arm; 60. Artificial implant; 601. Wire control end; 603. Eyelet; 604. Blood flow channel; 605. Connecting ear; 61. Inner frame; 63. Arm; 632. Outflow side; 631. Inflow side; 70. Catheter sheath; 7200. Fixing seat. DETAILED DESCRIPTION

[0143] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0144] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be a central component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be a central component at the same time.

[0145] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0146] In this application, the terms "first", "second", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number or order of the indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0147] This specification describes an artificial implant and a delivery system for delivering the artificial implant into a subject's body, wherein the delivery system includes a control handle and a catheter assembly, wherein the control handle can be connected to and control the catheter assembly for performing interventional surgery, wherein the catheter assembly includes a plurality of control components, wherein the distal ends of the control components cooperate with each other to operate the artificial implant, such as release, recovery, locking position, adjusting spatial posture, etc., wherein each control component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of multiple forms, wherein there are multiple control components, and at least two of them (taking the proximal end as an example) can slide relative to each other along the axial direction or rotate relative to each other around the axial direction. The force-applying component (the part that the user directly operates and contacts) on the control handle used to operate each control component can be directly fixedly transmitted to the corresponding control component, or can be transmitted by means of threads, gear racks, etc.

[0148] In the following, various improvements on the control handle or local structure can be implemented on the same control handle without obvious technical contradictions, but are not strictly limited to being implemented on the same control handle. For different numbers of controlled components and movement characteristics, or for control handles with further simplified structures, the various embodiments can also be implemented separately or in appropriate combination.

[0149] There are no strict restrictions on the application site and structure of artificial implants. In some drawings or texts, an artificial heart valve is taken as an example. The artificial heart valve generally includes a deformable stent and leaflets connected to the stent. The stent is cylindrical as a whole, 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 channel, and the multiple leaflets cooperate with each other to control the degree of opening and closing of the blood flow channel in the stent. In order to position it in the body, a positioning structure that can interact with the surrounding native tissue, such as anchor spikes, arms, etc., can be set on the periphery of the stent. In order to prevent peripheral leakage, a skirt or anti-peripheral leakage material can be set on the inner and / or outer sides of the stent.

[0150] Depending on the expansion mode, the corresponding material is selected during the processing of the stent, such as nickel-titanium alloy with shape memory that can self-expand in the body, or stainless steel that can be expanded by balloon, etc. The stent itself can be formed by cutting tubes or weaving wires, and the leaflets can be connected to the stent by sewing, bonding or integral mold molding.

[0151] Taking the self-expanding stent as an example, its expansion and retraction can be controlled by a sheath wrapped around the stent. The position of the stent exposed to the sheath is different and it can be controlled accordingly. It can also be controlled by a pull wire, that is, the pull wire passes through the structural gap (or wire hole structure) of the stent. The expansion degree of the stent can be changed by adjusting the tightness of the pull wire with a control handle. When the pull wire is pulled out of the stent, the stent is allowed to be completely released. Of course, the control of the pull wire is also completed through the various controlled components in the catheter assembly.

[0152] The stent of an artificial implant may generally have a connection structure that cooperates with the catheter assembly to limit the position of each other and prevent unnecessary positional displacement during transportation. The artificial implant is in a radially compressed state, i.e., a loaded state, when input, and is in an expanded state after being released from the constraints of the catheter assembly and radially expanded in the body. Unless otherwise specified, the shape of the artificial implant is understood to be in the expanded state, 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, catheter components often need to be bent. The corresponding bending parts can be in the form of tubes or wires, with the distal end acting on the bent part and the proximal end controlling the bending amplitude or direction through a control handle.

[0154] When used to indicate direction, the proximal end in the text generally refers to the side adjacent to the operator (such as a doctor), and the distal end is the relatively distant side. Along the interventional path, each component has a relative distal and proximal end. In theory, when the catheter assembly and the control handle are fully straightened, the straight line between the proximal and distal ends determines the axial direction, and correspondingly, the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction are also determined. When used to refer to a structure, the "end" in the text represents the endpoint of the structure, or a point or area on that side, or a specific structure connected to that point or area.

[0155] The present application provides a control mechanism for an artificial implant, comprising a base 10, a pull wire 11 and a lock 13, wherein the base 10 is provided with a lock hole, the pull wire 11 has a free end 111 that can be passed through or detached from the artificial implant 60, and the lock 13 is located at the distal end of the base 10 as a whole, and the lock 13 rotates with the base 10 to lock the free end 111 of the pull wire 11. The base 10 has a distal end 32 and a proximal end 31 opposite to each other, and an axial direction extending between the distal end 32 and the proximal end 31, and 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 without special instructions. The free end 111 is the end of the pull wire 11 that first passes through and finally detaches 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 the control end, and the control end can be directly fixed to the base 10, or can be extended to the proximal end and controlled.

[0156] The free end 111 has a first state (eg, Figure 1a ) and the second state of unrestricted (such as Figure 1b); the lock 13 is movably matched with the base 10, and the lock 13 is matched 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 matched 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 to 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. If necessary, the pull wire 11 can also be used to recycle the artificial implant.

[0157] In the second state, the free end 111 is disengaged from the locking element 13. At this time, the free end 111 can be understood to be released, thereby releasing the interconnection between the artificial implant and the control mechanism. Subsequently, the control mechanism can be withdrawn out of the body as a whole, leaving the artificial implant at a predetermined position in the body.

[0158] When the locking element, the base and the pull wire are preassembled in vitro, the pull wire 11 is inserted from the proximal end of the base, and then extends from the distal end of the base to pass through the artificial implant and then combine with the locking element 13 .

[0159] After releasing and detaching from the artificial implant, the control end is driven to move the pull wire 11 toward the proximal end to retract the pull wire; when retracting the artificial implant, 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 locking element 13 is located at the distal end of the base 10, which is conducive to observation and operation during in vitro preassembly, and is convenient for assembly. In particular, the locking element 13 and the base 10 are not nested in the radial direction, forming enough radial space for the pull wire to pass through, and making the pull wire smoother during the movement process. In addition, the radial maximum size of the base 10 and / or the locking element 13 can be reduced accordingly, which is convenient for in vivo intervention delivery. Of course, the control mechanism of the present application and other embodiments including the control mechanism of the present embodiment described below are also applicable to simulation training for in vitro intervention delivery operations. The inside of the prosthesis (such as an artificial organ for simulation training or observation, etc.) can also be understood as outside the body.

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

[0162] The artificial implant 60 is a cylindrical structure with a corresponding circumference, and a plurality of pull wires 11 are provided, and the control end 113 of each pull wire 11 can be controlled independently or moved synchronously. The positions where the pull wires 11 interact with the artificial implant 60 are arranged at intervals along the circumference of the artificial implant 60, which can improve the synchronization of the contraction and expansion of the artificial implant 60. For example Figure 3 There are three pull wires 11, which interact with the artificial implant 60 at three locations and are arranged at intervals around the circumference of the artificial implant.

[0163] Correspondingly, there are multiple locking areas 101, and the free end 111 of each pull wire 11 corresponds to one of the locking areas 101 in the first state to avoid 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 set on the base.

[0164] The control end 113 of each pull wire 11 can be directly extended to the control handle or indirectly transmitted through an intermediate piece to reduce the risk of multiple pull wires 11 being intertwined with each other, for example Figure 4 As shown, the control mechanism further includes a second shaft 23, and the control end 113 of each pull wire 11 is connected to the second shaft 23. By operating the second shaft 23, each pull wire 11 is synchronously controlled.

[0165] like Figure 5 As shown, the artificial implant 60 has a spatial axial direction, one end of which is a wire control end 601, which can be either the distal end or the 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 an eyelet 603 for a pull wire (not shown in the figure for clarity) to pass through.

[0166] The hole is formed in a manner such as the artificial implant including a hollow portion forming the hole, the hollow portion being a structural gap of the artificial implant; or the hole is formed by directly punching (e.g. Figure 5 ); or independently configured in an artificial implant (such as welding, etc.).

[0167] The holes 603 are 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 end 111 of the pull wire can limit the complete separation of the artificial implant 60 from the control mechanism in the first state, but the artificial implant can be allowed to deform to a certain extent by adjusting the length of the pull wire exposed outside the base, or it can be understood that the artificial implant changes its position relative to the base. Therefore, when the free end 111 of the pull wire remains in the first state, the artificial implant 60 can still have multiple states according to its own deformation degree, for example, relatively:

[0169] In the expanded state, the wire control end 601 radially expands away from the base 10 (eg Figure 6a ), the round trip paths of the same pull wire 11 passing through the artificial implant 60 do not overlap;

[0170] In the retracted state, the wire control end 601 is radially retracted close to the base 10 (such as Figure 6c );

[0171] In the intermediate state, the wire control terminal 601 is between the expanded state and the retracted state (eg Figure 6b ).

[0172] Among them, Figure 5 to Figure 7a As shown, a plurality of eyelets 603 are sequentially arranged at intervals along the circumferential direction. In the expanded state, the same pull wire 11 passes through at least two eyelets 603, that is, one pull wire 11 can act on two locations of the wire control end 601 in the circumferential direction. In a 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 allows the circumferential contraction and expansion of the wire control end 601 of the artificial implant 60 to be synchronized, and reduces the number of pull wires, avoiding entanglement and friction at the proximal end of the pull wires, and correspondingly reduces the space for accommodating the pull wires.

[0173] At least two pull wires are configured for the entire artificial implant 60. In addition, the pull wire is only allowed to be threaded once for the same eyelet to avoid the interference caused by reciprocating threading.

[0174] Figure 7a It can be seen that in this state, the extension direction (radial direction) of the pull wire between the artificial implant 60 and the base 10, that is, the traction force direction, is perpendicular to the unlocking movement direction (circumferential direction) of the lock, which makes unlocking easier.

[0175] For example Figure 7a and Figure 7b As shown, the round trip path of the same pull wire 11 through the artificial implant roughly encloses a triangular area, that is, the round trip paths do not overlap, otherwise the round trip paths overlap and the extension path of the pull wire 11 is a single straight line or curve, and does not enclose a certain area. The relationship between the insertion path of the pull wire 11 and the base 10 and the lock 13 is introduced in the following embodiment.

[0176] like Figure 10 to Figure 15The base 10 has a locking area 101, and the locking element 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 base 10 has a first cavity 103 inside, and the proximal side of the base 10 has a first opening 104 that is connected to the first cavity 103, and the outer peripheral surface of the base 10 has a second opening 108 that is connected to the first cavity 103; the pull wire 11 passes through the first cavity 103, and one end (i.e., the control end) of the pull wire 11 extends proximally out of the base 10 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 element 13 is not in the first cavity 103, so the movement of the pull wire 11 will not be interfered by the locking element 13, making the movement of the pull wire 11 smoother and facilitating the expansion control of the artificial implant.

[0178] The locking area 101 may be within the overall outer contour of the base 10 to accommodate the free end in the first state, and the locking area 101 may 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 , Fig.89 , showing that the locking element 13 slides axially so that the positioning portion 131 is separated from the locking area 101, allowing the pull wire 11 to be separated from the artificial implant. In this embodiment, the positioning portion 131, as a part of the locking element 13, has displacement in at least the circumferential direction during operation, which can reduce or even eliminate the axial stroke change of the locking element 13, reduce the axial space occupied by related components and even the proximal control handle, and is more conducive to the configuration of the transmission mechanism.

[0180] In the first state, the pull wire 11 is constrained by the artificial implant 60, and thus mainly moves in the radial direction; in the second state, the free end of the pull wire 11 is free. The range of the second opening 108 includes the radial side wall and the distal end surface of the base 10, which is conducive to the movement of the pull wire 11 in all directions in the first state, and the rapid and smooth withdrawal 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 a first state, the positioning portion 131 penetrates the ring 115a. When the free end 111 is in a second state, the positioning portion 131 withdraws the ring 115a. The ring 115a can be configured independently (e.g. Fig.16a ) or by winding the wire 11 itself (such as Fig.16bThe pull wire 11 is a single strand or multiple strands, for example, a single strand extending to the control end 113, or two strands extending in parallel to the control end 113, or two strands extending in parallel for a period and then being combined and then extending to the control end 113.

[0182] A plurality of locking areas 101 are arranged at intervals along the circumference of the base 10 , and the positioning portion 131 enters or moves out of each locking area 101 in sequence as the locking element 13 moves.

[0183] In one embodiment, if Fig.12 , Fig.13a 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. In the radial direction, the third shaft 25 is located at the outer periphery of the second shaft 23. The third shaft 25 and the second shaft 23 are both pipe fittings, wherein the distal end of the second shaft 23 has a connecting hole 231 for the pull wire control end to be wound and connected, and the connecting hole 231 corresponds to the pull wire one by one, specifically including the mutual correspondence in quantity and position. In the figure, there are three connecting holes 231, which are arranged at intervals along the circumferential direction.

[0184] like Fig.13a and Fig.13b In one embodiment, a plurality of notches 232 are spaced apart on the distal wall of the second shaft 23, and a connecting arm 233 is formed between adjacent notches 232. A connecting hole 231 is provided at the distal end of the connecting arm 233. When the second shaft 23 moves toward the distal end or the proximal end, the connecting arm 233 deforms in accordance with the movement of the self-adaptive pull wire, and the deformation includes at least radial deformation. In one embodiment, a deformation hole 234 is provided on the proximal side of the connecting hole 231 of the connecting arm 233.

[0185] like Figure 17 to Figure 18b In one embodiment, a plurality of partitions are arranged circumferentially on the base 10, and adjacent partitions separate the second opening 108. Therefore, the second opening 108 is arranged circumferentially on the base 10 at intervals, and the partitions are ribs 102 shown 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, which is convenient for the arrangement of the cable, for example, a cable extends through a locking area and then returns to the same locking area; or a cable extends through a locking area and then returns to the adjacent locking area, so that the two action points can be close enough. At the same time, the ribs 102 also serve as reinforcing ribs to maintain the basic strength requirements of the base.

[0186] In the first state, the free end 111 extends out of the base 10 through the corresponding second opening 108, passes through the artificial implant, and then returns to the locking area corresponding to the same second opening 108 (eg, Fig.18a ), or return to a position circumferentially adjacent to the second opening 108 (eg Fig.18b ).

[0187] like Fig.19 The position circumferentially adjacent to the second opening 108 may be another adjacent locking area 101, or a channel configured separately for threading the pull wire. The formation of the channel may adopt the same principle as the locking area in structure. For example, there are six second openings 108, three of which are spaced apart as channels for the free end of the pull wire to extend out of the base 10, and the other three are spaced apart as the locking area 101, for example Fig.19 In terms of circumferential span, the span of the locking area 101 is α, and the span of the circumferentially adjacent channel is β, satisfying α / β=1.1~2.

[0188] like Fig.17 All ribs 102 converge and fix to each other at the distal end of the base 10, and converge into an annular structure 107. All ribs 102 are continuously distributed circumferentially 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 annular structure 107 can be used for other pipes to pass through, such as the first shaft below.

[0189] like Fig.20a and Fig.20b In one embodiment, the base 10 is provided with a locking hole 105 for the positioning portion 131 to be inserted. The positioning portion 131 has:

[0190] In the locked state, the positioning portion 131 is inserted into the lock hole 105, restricting the free end 111 of the pull wire 11 from being disengaged (such as Fig.20a );

[0191] In the unlocked state, the positioning portion 131 exits the lock hole 105, allowing the free end 111 of the pull wire 11 to be disengaged (e.g. Fig.20b );

[0192] like Fig.21a The locking area 101a is between the two ribs 102a and 102b. The free end 111 of the pull wire 11 is located in the current locking area 101 in the first state. The two ribs have corresponding locking holes 105a and 105b on the opposite sides. Of course, the locking holes can also penetrate the ribs. One section of the positioning portion 131 is in the locking area 101a, and the two ends of the section are respectively inserted into the locking holes 105a and 105b. Combined with the movement direction of the lock 13, the opening direction of the locking hole 105 is the circumferential direction of the base 10.

[0193] The positioning portion 131 is arranged along a first direction (eg Fig.20b When the free end 111 moves in the middle X), it switches from the second state to the first state, and the locking hole 105 passes through the rib 102 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.

[0194] In terms of quantity, there are multiple ribs 102 with lock holes 105, and the positioning portion 131 as a whole has a relatively opposite end 13110 and a head end 13130, and the head end 13130 ​​is inserted in sequence as the lock member 13 rotates (such as Fig.20a ) or disengage from each lock hole 105 in sequence (such as Fig.20b ). Take the insertion of the positioning parts as an example. Figure 21a to Figure 21c The head end 13130 ​​is sequentially coupled to 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. Sequential disengagement is the opposite of sequential coupling. The advantage of sequential insertion is that the positioning part and the pull wire are sequentially coupled during in vitro pre-assembly, which facilitates assembly.

[0195] In a preferred embodiment, all ribs 102 are provided with locking holes 105, through which the positioning portion 131 rotates and passes in sequence, and provides a certain movement guide. During the process of the locking element rotating and inserting into each locking hole, the head end 13130 ​​eventually abuts against the side wall of one of the ribs 102, or is placed in the corresponding locking hole, playing a role of limiting.

[0196] When the positioning portion 131 is a multi-turn spiral, the opening position of the locking hole 105 of each rib 102 is adapted to the positioning portion 131. There are one or more locking holes 105 on the same rib 102. The multiple locking holes 105 are arranged in sequence along the extension direction of the rib 102.

[0197] See also Fig. 22 In one embodiment, one section of the rib 102 along the axial direction is a bent section 1021 extending radially inward, and the locking hole 105 is located at the bent section 1021 corresponding to the rib 102. All the bent sections 1021 form an escape zone 1022 (the dotted area in the figure) as a whole, and the proximal end of the artificial implant is in the escape zone 1022 in the retracted state. It is also convenient to guide the following loading section to be partially placed in the escape zone 1022 and aligned with the outer periphery of the base 10 when withdrawing.

[0198] In combination with the rotating characteristics of the lock and the circumferential distribution of each pull wire, the positioning portion 131 has a curved shape and the curved extension path is around the circumference of the base. The curved setting can make full use of the circumferential space and maintain the necessary length of the lock. The free ends of all pull wires can be controlled by the same lock, and the axial dimension change of the control mechanism is eliminated. The function of the original lock to cooperate with the pull wires one by one is retained, which facilitates the coordinated assembly of the lock, pull wire and base during the assembly stage.

[0199] Specifically, the opening of the lock hole faces the circumference of the base, the positioning part is in the shape of a rod, which can be a straight rod or a curved rod, and there is only one rod that matches the free ends of all the pull wires. The positioning part is inserted into or out of the lock hole as the lock rotates. Fig.23a , Figure 23b The positioning portion 131 is a spiral structure, and the spiral structure is wound at least once. For example, the spiral structure is a multi-turn structure, and the turns are arranged along the axial direction (the turns are arranged around the circumference of the base). The generatrix of the spiral structure can be an oblique line (away from or close to the axis of the base) or a straight line, for example, the spiral extension path is a cylindrical spiral or at least partly a conical spiral.

[0200] like Figure 24a to Figure 24c The lock 13 has a connecting portion 135 at the distal end of the base 10, and the control mechanism further includes a first shaft 21 in transmission cooperation with the connecting portion 135 to drive the lock 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] In the winding direction of the spiral structure, the positioning portion 131 as a whole has a relative end 13110 and a head end 13130, wherein the portion where one end is located is fixed to the connecting portion 135, and the other end is relatively free. The connection method of the positioning portion 131 and the connecting portion 135 includes a separate connection, such as welding or assembly, or an integral molding.

[0202] In one embodiment, a positioning mechanism for pre-assembly maintaining the axial position of the connection part 135 and the base 10 is provided between the connection part 135 and the base 10. The connection part 135 may be a tubular shape extending in equal diameters, and the positioning mechanism includes a first end face provided at the proximal end of the connection part and a second end face provided at the distal end of the base and abutting against the first end face. During pre-assembly, the first end face abuts against the second end face, and the locking hole of the positioning part and the base are matched in place.

[0203] Among them, the head end 13130 ​​of the positioning portion 131 needs to adapt to the radial position of the lock hole, and the part close to the end 13110 needs to be fixedly connected to the connecting portion 135. There is a large deviation between the outer diameter of the connecting portion and the radial position of the lock hole. Therefore, the spiral extension path of the positioning portion 131 is a conical spiral; or Fig.25a and Fig.25b The proximal end of the connecting portion 135 is radially expanded to form a connecting section 1351. The distal end of the base 10 has an extension section 106. The connecting section 1351 and the extension section 106 are mutually nested. In the figure, the connecting section 1351 is a cylindrical structure and is sleeved on the outer circumference of the extension section 106. The connecting section 1351 compensates for the above deviation, so the spiral extension path of the positioning portion 131 is a cylindrical spiral. At this time, the bottom wall of the connecting section 1351 is the first end surface.

[0204] The connecting portion 135 is movably sleeved on the outer circumference of the distal end of the first shaft 21, and the connecting portion 135 and the distal end of the first shaft 21 can be axially separated. When the two are matched, 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 lock 13 to rotate. As for axial separation, the two can be separated from each other to release the match or combined with each other to keep synchronization, and the matching relationship between the two can be switched according to the operation requirements.

[0205] like Fig.28 Regarding the threading path of the pull wire, the pull wire 11 has an advancing section 112, a return section 114 and an intermediate section 116 therebetween in the first state. The three sections form a triangular structure of the round-trip path in the above embodiment, and the free end 111 is arranged at the end of the return section 114. In one embodiment, the positioning portion is a multi-turn spiral structure, and there is an axial gap between adjacent turns. The advancing section can pass through the axial gap at the proximal end of the positioning portion and interact with it to form a first action point (X1 described below), and the return section is connected to the positioning portion and interacts with it to form a second action point (X2 described below). The two force points are close to each other, so that the movement of each position of the artificial implant is relatively synchronized when it is recovered and expanded.

[0206] In another embodiment, if Fig.20a , the forward section 112 extends directly through the locking area 101 (without passing through the axial gap) and interacts with it to form a first action point (X1 described below), and the return section 114 is connected to the positioning portion 131 and interacts with it to form a second action point (X2 described below). Combined with the foregoing, the space in the locking area 101 is larger than the axial gap, which is convenient for threading the pull wire. And during pre-assembly, the pull wire can be passed through the base first, and then the lock and the base are rotated to match, and the free end is inserted at the same time to facilitate assembly. Among them, the pull wire 11b is the state after threading is completed, and the bold parts are the forward section 112 and the return section 114 of the pull wire 11b. As Figure 7a The pull wire 11b forms two action points (X1, X2) in the locking area 101 or the positioning portion 131, and two action points (Y1, Y2) between the pull wire 11b and the artificial implant.

[0207] Here is a description of the existing technology: Fig.26 In the figure, three holes 603 are arranged at intervals in the circumferential direction of the artificial implant 60, corresponding to three pull wires, and the specific threading path is referenced to the pull wire 11c, and their round trip paths coincide. During the retraction process, the force generated by the pull wire is only radial, and the artificial implant will generate corresponding stress in the circumferential direction and react to the pull wire, so that the force required to be applied to the pull wire gradually increases, affecting the operation feel.

[0208] However, the pull line of this embodiment is in a triangle shape, which generates a radial force and also generates a force on the line connecting the two connection points (Y1, Y2) (such as Figure 7aThe invention (as shown by the solid arrow in the middle) can directly overcome the stress change during the deformation process of the artificial implant. The change of the overall force of the pull wire is smaller than that of the existing one, and the operation feel is more delicate.

[0209] In conventional technology, the interval between two adjacent holes 603 is relatively far (i.e., the circumferential span is large), and the holes 603 are provided on the connecting ears 605 (e.g., Fig.27a ), the adjacent connecting ears 605 are independently connected to the pull wire, and in the process of folding, the adjacent connecting ears 605 may eventually be misaligned and overlapped with each other (such as Figure 27b However, the threading path of the pull wire in this embodiment makes the connection ear 605 and the structural gap mostly or completely controlled by the pull wire, reducing or even eliminating the problem of misalignment and overlap during folding (such as Figure 7b ).

[0210] The two action points (X1, X2) are in the same locking area and close to each other, so the round trip path of the pull wire is roughly an equilateral triangle, that is, Figure 7a The lengths of the two bold forward sections 112 and the return section 114 are equal, and the corresponding moving speeds of the forward section 112 and the return section 114 are the same, which improves the synchronization of the contraction or expansion of the artificial implant 60. Fig.28 In the figure, when the circumferential span of the two action points (X1, X2) is large, the lengths of the corresponding forward section 112 and the return section 114 are different, and the corresponding movement speeds are different, resulting in abnormal contraction / expansion of the artificial implant.

[0211] In order to improve the synchronization of the contraction and expansion of artificial implants, the prior art needs to configure a larger number of pull wires (for example, more than six), but it is correspondingly necessary to consider whether the spatial arrangement of each pull wire at the proximal end is allowed, and the pull wires may be too close to each other and rub or entangle with each other. The threading method of this embodiment requires fewer pull wires, thereby meeting the space requirement. The above-mentioned control mechanism can be installed in a conveying system, and the conveying system also includes a control handle at the proximal end of the conveying system and an inner shaft assembly connected between the control handle and the control mechanism, and the inner shaft assembly includes the above-mentioned first shaft, second shaft and third shaft.

[0212] In some embodiments, the delivery system further comprises an outer sheath sleeved on the inner shaft assembly, and during the interventional delivery process, the distal end of the outer sheath encloses part or all of the control mechanism and the artificial implant.

[0213] See also Fig.11 , Fig.29 , Fig.30a and Fig.30bThe present application also provides a locking mechanism for connecting an artificial implant to a delivery system, which includes a first shaft 21, a pull wire 11, a third shaft 25 and a linkage assembly. A loading section 211 is fixed to the distal end of the first shaft 21, and the loading section 211 is open toward the proximal end and is used to accommodate the distal end of the artificial implant 60. The pull wire 11 has a free end 111, and the free end 111 can be passed around or detached from the artificial implant 60. The third shaft 25 is slidably sleeved outside the first shaft 21, and a locking assembly is installed on the third shaft 25. The artificial implant 60 is bound to the locking assembly by the pull wire 11 during loading. The locking assembly includes a locking member 13 and a base 10, and the two have a mutually matched locking state (the corresponding pull wire is in the first state) and a release state (the corresponding pull wire is in the second state), and each state respectively restricts and allows the pull wire 11 to detach from the artificial implant 60. The relationship between the proximal end of the artificial implant, the pull wire 11 and the locking assembly can refer to the above-mentioned embodiment. For example, the locking mechanism may further include a second shaft 23 slidably disposed between the first shaft 21 and the third shaft 25 and having its proximal end controlled by a control handle, and 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 13 to selectively link the two. It can be understood that the first shaft 21 and the lock 13 have a combined state in which they cooperate with each other and the first shaft 21 drives the lock 13 to move, and a separated state in which the cooperation is released so that the two are independent of each other. The timing of the combination should be after the artificial implant 60 is accurately positioned and expanded, and before the delivery system is ready to be withdrawn. The way of combining / separating the two can be the movement of at least one of them relative to the other. Combined with the above, for example, the lock 13 is located at the distal end of the base, the linkage assembly includes two matching parts, one is connected to the loading section 211, and the other is connected to the lock 13. The axial movement of the loading section 211 can make the two matching parts linked or disengaged. In one embodiment, after the artificial implant 60 is accurately positioned and expanded, the loading section 211 at the distal end is first moved toward the proximal end and combined with the locking element 13. At this time, the loading section 211 is bound to be in the artificial implant 60 in terms of axial position, and then the first shaft 21 is rotated and the control of the pull wire 11 is released through the linkage assembly. During the rotation operation, the proximal end of the loading section 211 is not easy to or even will not interfere with the distal end of the artificial implant, for example, the loading section 211 is hung at the distal end of the artificial implant. In addition, there is no need to set a separate drive tube for the locking element, which simplifies the structure.

[0215] The two matching parts are linkage keys and linkage grooves that can be axially slidably separated, and the linkage keys are rotated and linked to each other when inserted into the linkage grooves. Of course, the two matching parts can also be linkage keys and linkage grooves that can be relatively rotated and separated, and the linkage keys are axially linked to each other when inserted into the linkage grooves. Among them, there are multiple linkage keys, the loading section and the locking element are at least partially tubular, and the multiple linkage keys are arranged along the circumference of the tubular part, and accordingly, there are multiple linkage grooves.

[0216] See also Figure 31 to Figure 34b In combination with the above structure of the lock 13, in one embodiment, at least a portion of the lock 13 is a connecting portion 135, and the first shaft 21 and the connecting portion 135 are selectively matched through a linkage assembly and are used to drive the lock 13 to rotate relative to the base 10. The linkage key 1352 is radially protruded on one of the connecting portion 135 and the first shaft 21; the linkage groove 2141 cooperates with the linkage key 1352 and is provided on the other of the connecting portion 135 and the first shaft 21, and the linkage key 1352 and the linkage groove 2141 are open to the end surface of the one in which they are located. In the figure, the linkage key 1352 is provided at the distal end of the connecting portion 135, and the linkage groove 2141 is provided on the loading section 211. The rotational linkage between the two is manifested in that in the circumferential direction, the side wall of the linkage groove 2141 abuts against the side wall of the linkage key 1352 (such as Fig.31 The connecting portion 135 is a cylindrical structure, and the linkage key 1352 is a sheet. In one embodiment, the linkage keys 1352 are distributed at 2 to 4 locations along the circumferential direction, for example, there are 2 linkage keys 1352.

[0217] Preferably, the notch of the linkage groove 2141 is provided with an expansion 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 closing structure 1354 for guiding the insertion into the notch.

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

[0219] In one embodiment, the limiting structure includes a positioning piece 2131 radially protruding from the outer periphery of the support member, and a positioning groove provided on the inner peripheral surface of the loading section 211 and cooperating with the positioning piece 2131 .

[0220] The support member 212 is a cylindrical structure, and the outer periphery is partially turned outward to form a positioning piece 2131. The support member 212 includes an outer cylinder 2130 connected to the loading section 211, and an inner cylinder 2140 with a linkage key fixed to the first shaft 21. The inner cylinder and the outer cylinder can be integrally formed or a separate structure, such as bonding. The outer periphery of the outer cylinder 2130 is partially turned outward to form the positioning piece 2131, and the inner cylinder 2140 is partially recessed to form a linkage groove 2141.

[0221] The loading section 211 has a guide head 215 located at the distal end and connected to the first shaft 21, and a loading part 216 connected to the guide head 215 for accommodating the distal part of the artificial implant. The support member 212 is arranged in the guide head 215. The distal end of the guide head 215 is in a shape that gradually converges toward the distal end, and the proximal end face is a plane and perpendicular to the axial direction. When the loading section 211 is in a combined state, the proximal end face of the loading part 216 abuts against the base 10. Specifically, in combination with the aforementioned embodiment, the proximal end face of the loading part 216 abuts against the rib 102 of the base 10. In one embodiment, the loading section 211 and the base 10 have the same diameter, and in the combined state, the outer peripheral surfaces of the two are flush.

[0222] The locking element will move distally during the rotation unlocking process. In one embodiment, when the loading section 211 and the locking element 13 are in the combined state, the linkage key and the linkage groove have an axial gap L1 in the axial direction for the connection part to move distally. Similarly, the proximal end surface of the guide head has the same axial gap L1 as the above from the positioning part 131. The axial gap L1 is greater than the movement amount of the locking element 13 moving distally.

[0223] like Fig.35 The distal end of the first shaft 21 is fixed with a tubular extension tube 27 extending out of the base, the locking member 13 is sleeved on the outer periphery of the extension tube 27, and the loading section 211 is arranged at the distal end of the extension tube 27. In one embodiment, the first shaft 21 is sleeved and connected to the proximal end of the extension tube 27, that is, the outer diameter of the first shaft 21 is larger than the outer diameter of the extension tube 27, the distal end of the first shaft 21 extends close to the base 10, and the proximal end is extended with equal diameter and connected to the control handle, and its thicker tube diameter facilitates the transmission and control of force. The thinner tube diameter of the extension tube 27 facilitates the arrangement of components such as the distal locking assembly and the loading section, and reduces the overall radial size. The proximal end of the extension tube 27 extends into the base and is connected and fixed to the first shaft 21. In the following embodiments, unless otherwise specified, the extension tube 27 is regarded as a part of the first shaft 21.

[0224] like Figure 35 to Figure 38 An embodiment of the present application further provides a loading structure of an artificial implant, wherein the artificial implant 60 comprises an inner frame 61, wherein the outer periphery of the inner frame has a plurality of arms 63, wherein a first gap for accommodating native tissue is formed between each arm 63 and the inner frame 61, and the loading structure comprises a first shaft 21 and a loading section 211, wherein the inner frame 61 is sleeved on the outer periphery of the first shaft 21 in a compressed state; the loading section 211 is tubular and fixed to the distal end of the first shaft 21, and the loading section 211 is open toward the proximal end, wherein the entire inner frame 61 or at least the distal end portion of the inner frame 61 is accommodated in the loading section 211, and a clearance opening 217 is provided on the peripheral wall of the loading section 211, wherein at least a portion of the arms 63 is located at the clearance opening 217.

[0225] The loading section 211 restrains the distal end of the artificial implant 60, keeps the artificial implant in a folded state, and ensures safe interventional delivery. At the same time, part of the arm 63 enters the avoidance opening 217, which is located in the section with the largest radial space of the loading section 211, that is, on the aforementioned loading section 216. Compared with the existing structure that completely wraps the artificial implant, the radial size of the loading section of this embodiment is smaller, which is conducive to interventional delivery.

[0226] Wherein, when the artificial implant is in a loaded state, the radial relationship between the arm and the loading section and the corresponding method of releasing the restraint on the arm are as follows: Fig.36a , the arm 63 is at least partially in the loading section 211; then the loading section 211 is moved axially to release the restraint of the loading section 211. If there is a catheter sheath wrapped outside the loading section 211, the catheter sheath 70 needs to be moved first.

[0227] Or Fig.36b and Fig.36c As shown, the loading structure includes a guide sheath 70, which is slidably mounted on the outermost side of the inner shaft assembly, and the arm portion 63 is located between the loading section 211 and the guide sheath 70. After the guide sheath 70 is moved, the restraint on the arm portion 63 can be released. In one embodiment, the distal end portion of the artificial implant is located in the loading section, and the proximal end portion is located outside the loading section and in the guide sheath.

[0228] The outflow side 632 of each arm 63 is fixedly connected to the inner frame 61, and the inflow side 631 forms a first gap with the inner frame 61 after expansion, and the inflow side 631 is located at the avoidance port 217. The artificial implant includes an inner frame that defines a blood flow channel, and the outer periphery of the inner frame has a plurality of arms, and a first gap that can accommodate native tissue is formed between each arm and the inner frame, and a leaflet that controls the blood flow channel is connected to the inner frame. The inner frame 61 and the arm 63 are fixed separately or adopt an integral structure. The inner frame 61 and the arm 63 are cut as a whole from a tubular blank, and along the axial direction of the tubular blank, the inflow sides of the inner frame 61 and the arm 63 are away from each other. Among them, the inner frame 61 is a radially deformable cylindrical structure, and the blood flow channel 604 is inside; the leaflet is connected to the inner frame 61 to change the opening degree of the blood flow channel; the arm 63 itself is an integral annular structure, and the outflow side 632 of each arm 63 is fixedly connected to the inner frame 61.

[0229] like Figure 39-40One embodiment of the present application also provides an interventional delivery system for an artificial implant, comprising a catheter sheath 70 (i.e., the outer sheath mentioned above), a bending adjustment assembly, an inner shaft assembly, and a control handle 3; the catheter sheath 70 is used to construct an interventional channel extending from outside the body to the adjacent 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 adjustment assembly can be controlled to change its direction, and the bending adjustment assembly slides through the fixing seat 7200 and further extends proximally; the distal end of the inner shaft assembly is provided with a loading section for connecting the artificial implant 60, and the loading section is always exposed to the distal end of the bending adjustment assembly; the control handle 3 connects the bending adjustment assembly and the proximal end of the inner shaft assembly, and 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 is adjustable. The catheter sheath 70 of this embodiment is used to assist in the recovery of the artificial implant.

[0230] The specific length of the catheter sheath can reach a more distant surgical site, and wrap the control mechanism, the proximal part of the artificial implant and / or the loading section in the above-mentioned embodiment during the interventional delivery process. The catheter sheath 70 includes a tube body 51, and the tube body 51 includes a main section 510 and a deformation section 520. The fixing seat 7200 is connected to the proximal end of the main section 510, and the deformation section 520 is located at the distal end of the main section 510. In one embodiment, the fixing seat 7200 is a hemostatic valve, and the hemostatic valve can adopt existing technology.

[0231] The bending components include:

[0232] The sheath tube 430 is bent, and the proximal end is fixed to the control handle 3;

[0233] The bending member has one end fixedly extending to the distal end of the bending sheath tube 430 and acting on the catheter sheath, and the other end is controlled by the bending drive mechanism. 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 drive the bending sheath tube 430 to bend.

[0234] An embodiment of the present application also provides a control method of an interventional delivery system, the system is used for interventional delivery of the artificial implant of the above embodiment, the delivery system also includes the control mechanism and control handle of the above embodiment, and an inner shaft assembly connecting the control handle and the control mechanism and the loading section. The control method includes:

[0235] First, expanding at least a portion of the arm to align the first gap with the native tissue;

[0236] Driving the loading section 211 to the distal end to separate from the inner frame 61, so that the distal end of the inner frame 61 expands;

[0237] By releasing the pull wire 11 and partially expanding the proximal portion of the inner frame 61 exposed to the base, the inner frame is deformed as a whole to a desired extent, and the pull wire 11 is always kept controlling the inner frame 61 during the process;

[0238] Move the loading section 211 proximally so that the loading section 211 enters the blood flow channel 604;

[0239] The connection between the pull wire 11 and the inner frame 61 is released.

[0240] Detailed description is made in conjunction with the drawings: After the artificial implant is delivered to the predetermined position in the body, the loading section 211 is driven distally or the guide sheath or its internal structure is driven to make the two move axially in opposite directions (according to the different settings of the arm) until at least a part of the arm is released and expanded, the distal end of the inner frame is still bound by the loading section 211, and the first gap is aligned with the native tissue. This embodiment takes the solution in which the arm is set between the loading section and the guide sheath 70 as an example and is described in conjunction with the drawings:

[0241] like Fig.41a and Fig.41b , driving the catheter sheath 70 to move proximally or driving the internal structure of the catheter sheath to move distally, releasing the restraint of the catheter sheath on the arm portion 63, and the arm portion 63 expands radially outward.

[0242] like Fig.41c , and then push the first shaft 21 to the distal end to release the restraint of the loading section on the artificial implant, that is, the distal end of the inner frame loses its restraint and expands radially outward, and then prepares to expand the proximal end of the inner frame.

[0243] like Fig.41d and Fig.41e , keep the third shaft 25 stationary, push the second shaft 23 toward the distal end, and move the control end 113 of the pull wire 11 toward the distal end 32, so that the part of the pull wire 11 exposed outside the base gradually stretches, allowing the artificial implant 60 (mainly the proximal part) to gradually expand, and the pull wire outside the base 10 will gradually stretch in the direction of the arrow; the control end 113 continues to move until Fig.41d The artificial implant 60 is in an expanded state (ie, the expected amplitude), and after being confirmed to be in the expected fit with the surrounding tissue, the pull wire can be released.

[0244] When releasing the pull line, Figure 41f The first axis moves proximally until the loading section enters the blood flow channel and the loading section 211 is combined with the locking element 13 through a linkage assembly. The first axis 21 is rotated to drive the locking element 13 to rotate relative to the base 10, and all the pull wires 11 are released in turn until all the free ends 111 are completely separated from the locking element 13.

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

[0246] Finally Figure 41g , withdraw the entire delivery system out of the body.

[0247] During the process of retracting the loading section 211 into the blood flow channel, the pull wire remains in the first state to keep the components of the control mechanism and the artificial implant in a relatively fixed spatial posture, thereby guiding the loading section 211 to be smoothly retracted into the blood flow channel, and reducing or eliminating the safety risk of the loading section 211 being mounted on the distal end of the artificial implant during retraction.

[0248] In addition, before the pull wire is unlocked, a recovery operation can be performed as needed. The recovery operation generally needs to be combined with other components, such as the catheter sheath of the aforementioned embodiment. The specific operation is: when the pull wire is in the first state, the control end of the pull wire is driven to move proximally, and the proximal end of the artificial implant is retracted by the pull wire. Then, as needed, the remaining components in the catheter sheath are moved proximally back into the catheter sheath, or the catheter sheath is pushed distally to accommodate the artificial implant.

[0249] In the early 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 in a state of mutual abutment. In this state, there is a large force between the catheter sheath and the artificial implant, and this force is fed back to the control handle so that the operator feels obvious operation damping force. In this state, the artificial implant is recovered by referring to the telescopic assembly and the push-up drive mechanism of the following embodiment.

[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 used to directly drive the catheter sheath to move toward the distal end to quickly eliminate the gap; the following method can also be used to drive the inner shaft assembly to move toward the proximal end to eliminate the gap; or the above two methods can be combined to eliminate the gap until the operator clearly feels the operational damping force, proving that the catheter sheath and the artificial implant are abutting against each other.

[0251] It should be noted that the position of the axis in the figure is not limiting, the control end can be very long or very short, or the cable can be directly connected to the control handle for direct retraction. For the control of the cable, the control end of the cable can also be extended and directly controlled by the control handle.

[0252] The above control handle can be a conventional control handle. This specification provides another control handle, such as Figure 42 to Figure 45 The control handle has relative distal and proximal ends, and an axial direction extending between the proximal and distal ends. The distal end of the control handle 3 is provided with an axially retractable push-up mechanism, which includes a telescopic component 38 and a push-up drive mechanism 39. The distal end of the telescopic component 38 has a stop member 384, and the proximal end is axially movably connected to the control handle 3. The push-up drive mechanism 39 is installed on the control handle 3 and linked with the proximal end of the telescopic component 38.

[0253] The telescopic assembly 38 is used to adjust the distance between the abutment member 384 and the catheter sheath in the aforementioned embodiment, and can keep the abutment member at any position. The telescopic assembly 38 can maintain the distance between the abutment member 384 and the catheter sheath, which is convenient for interventional delivery operations. When retrieving the artificial implant, the abutment 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 retrieved into the catheter sheath 70;

[0254] Alternatively, the push-up drive mechanism 39 acts on the final stage 383 to drive the telescopic assembly 38 to move further distally, and drives the catheter sheath 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 area within the body. Therefore, the telescopic component 38 is first extended to the area, and at this time, the distal end of the catheter sheath 70 is close to the control mechanism, which reduces the distance between the catheter sheath and the artificial implant. The inner shaft component is then withdrawn until the artificial implant is also located in the area, and finally the push-up drive mechanism 39 completes the recovery of the artificial implant according to the above operation.

[0256] The telescopic assembly 38 can move quickly to eliminate the distance between the abutment member 384 and the catheter sheath, which is a rough adjustment. The push-up drive mechanism 39 can control and accurately adjust the axial movement distance of the telescopic assembly 38, which is a fine adjustment.

[0257] In one embodiment, the telescopic assembly 38 is arranged in one or more stages from the distal end to the proximal end, the distal end of the first stage 381 is provided with abutment 384, and the proximal end of the final stage 383 is linked with the ejection drive mechanism 39. Each stage of the telescopic assembly 38 is a cylindrical structure and is movably plugged in sequence. While ensuring the adjustment distance, the axial space is saved and the axial size of the control handle is reduced. One of the adjacent stages is an outer cylinder and the other is an inner cylinder. When the telescopic assembly 38 is extended, the inner cylinder moves toward the distal end relative to the outer cylinder. Conversely, when the telescopic assembly 38 is shortened, the inner cylinder moves toward the proximal end relative to the outer cylinder. The telescopic assembly 38 has a first limit of the maximum length and a second limit of the minimum length. Among them, the telescopic assembly 38 includes a first stage 381, an intermediate stage 382 and a final stage 383 from the inside to the outside.

[0258] In one embodiment, mutually cooperating stop structures are provided between adjacent stages, which at least restrict the proximal movement of the inner cylinder relative to the outer cylinder, and the restriction of the stop structure needs to be released during operation; and for the distal movement of the inner cylinder relative to the outer cylinder, the stop mechanism can restrict or only provide a certain resistance, for example, the restriction of the stop mechanism can be released under the action of artificial external force.

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

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

[0261] A catheter sheath is used to construct an intervention channel, and the proximal end of the catheter sheath is provided with a fixing seat;

[0262] An inner shaft assembly having a loading section at the distal end, wherein the artificial implant is at least partially located in the loading section and is releasably connected to the inner shaft assembly before expansion;

[0263] A control handle is connected to the proximal end of the inner shaft assembly, the control handle is located on the proximal side of the fixing seat, and a push mechanism that can interact with the fixing seat is provided at the distal end of the control handle;

[0264] The artificial implant at least partially remains connected to the inner shaft assembly. When it is recovered, the catheter sheath is driven to move relative to the inner shaft assembly so that the artificial implant is received in the catheter sheath.

[0265] The proximal end and the distal end of the present embodiment are not strictly limited to installation positions, but may also be position indications, for example, the ejection mechanism may extend to a control handle.

[0266] The relative movement of the catheter sheath and the inner shaft assembly can be the catheter sheath moving toward the distal end, or the inner shaft assembly moving toward the proximal end, or the inner shaft assembly moving toward the proximal end and the catheter sheath moving toward the distal end until the distal end of the catheter sheath approaches or contacts the artificial implant, eliminating the aforementioned gap, and waiting for the next step of operation. During recovery, the proximal end of the fixed seat can be abutted by a push-up mechanism or other components to provide sufficient force transmission for easy recovery operation. The artificial implant, catheter sheath, inner shaft assembly and control handle refer to the structure of the aforementioned embodiment. Specifically, in one embodiment, the distal end of the catheter sheath approaches or contacts the artificial implant, and the push-up mechanism is driven to abut against the fixed seat. The telescopic assembly is first extended toward the distal end until the head abuts against the fixed seat, and then the push-up drive mechanism is controlled to drive the telescopic assembly as a whole to move toward the distal end and act on the catheter sheath through the fixed seat to make it move toward the distal end until the recovery of the artificial implant is completed.

[0267] The expansion of at least a portion of the artificial implant relative to the inner shaft assembly is understood to be deformation and expansion or expansion after the distal side is separated from the loading section or the catheter sheath, etc. In one embodiment, the artificial implant is connected to the inner shaft assembly by a pull wire. When recovering, the pull wire is kept in a tightened state to gather the proximal side of the artificial implant, which is conducive to the smooth entry of the proximal end of the artificial implant into the catheter sheath during recovery. Wherein, before recovery, the shape of the artificial implant may be in an expanded state, and the pull wire needs to be tightened first to gather the proximal side of the artificial implant. Wherein, when recovering, the proximal end of the arm of the artificial implant enters the catheter sheath first, and the distal end of the arm enters the catheter sheath as the catheter sheath adapts to the movement of the artificial implant.

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

[0269] Provided are an artificial implant and a delivery system, wherein the artificial implant comprises an inner frame, and a plurality of arms are arranged on the outer periphery of the inner frame. The delivery system comprises:

[0270] a catheter sheath with a fixing seat at the proximal end;

[0271] An inner shaft assembly is movably arranged in the catheter sheath, and a loading section is provided at the distal end of the inner shaft assembly;

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

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

[0274] Before loading, the artificial implant is in an expanded state and is separated from the delivery system. In one embodiment, the artificial implant is connected to the delivery system by passing a pull wire around the proximal end of the inner frame. Referring to the above structure, the delivery system also includes a control mechanism, which includes a base connected to the inner shaft assembly, a locking member movably matched with the base, and a plurality of pull wires; the inner shaft assembly refers to the above embodiment.

[0275] One end of the pull wire (i.e., the control end) 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, extends the length exposed outside the base to provide a sufficient length for the pull wire to pass around the proximal end of the inner frame and return to the corresponding locking area of ​​the base to wait to be locked to the base and the locking element, wherein multiple pull wires are locked one by one. During the locking process, the locking element moves relative to the base in a rotating manner.

[0276] Next, the control handle is operated to drive the control end of the pull wire to move toward the proximal end to tighten the pull wire, that is, shorten the length of the pull wire exposed outside the base, and radially compress the proximal end of the inner frame until it is close to the base. During the tightening process, all pull wires are tightened synchronously.

[0277] Next, the far 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 accommodate the distal end of the inner frame. At this time, the arm is still in an expanded state and is not accommodated by the loading section. The control handle is then operated to drive the catheter sheath to move distally to accommodate the arm and the proximal end of the inner frame. The method of compressing the inner frame can be in a cold water bath, through a crimping device or manual compression.

[0279] In another embodiment, the distal ends of the inner frame and the arm are compressed, and the operating control handle drives the loading section to move proximally to accommodate the distal end of the inner frame and at least the distal portion of the arm. The operating control handle then drives the catheter sheath to move distally to accommodate the proximal end of the inner frame and the exposed portion of the arm. Among them, the method of compressing the inner frame and the arm can be through a crimping device or manual compression in a cold water bath. In one embodiment, the arm avoids the loading section or is placed on the outer periphery of the loading section, and the distal end of the catheter sheath is against the axial direction of the loading section, or wraps the proximal portion of the loading section. In one embodiment, the method of distally moving the catheter sheath includes driving the catheter sheath to push the fixing seat distally relative to the control handle.

[0280] In the above two embodiments, the loading section has an escape opening, and in the process of storing the distal end of the inner frame, the escape opening is first aligned with the arm in the circumferential direction. The circumferential alignment method includes operating the control handle to drive the loading section to rotate in the circumferential direction. Figures 46 to 63 The present application also provides a control handle 3, connected to a control catheter assembly 4, comprising:

[0281] The support body 3300 includes two rigid bars 333 arranged side by side, and a guide channel 334 is defined between the two rigid bars 333;

[0282] The driving mechanism is configured with multiple sets, wherein at least two sets of the driving mechanism respectively include a transmission member 340 slidably mounted on the guide channel 334 , and a driving sleeve 350 rotatably sleeved on the outer periphery of the support body and threadedly matched with the transmission member 340 .

[0283] The support body adopts two rigid strip structures. On the one hand, the two radially opposite sides of the guide channel are connected, which is convenient for the radial installation of the transmission part. At the same time, the axial direction of the guide channel is also connected to meet the movement requirements of the transmission part. In addition, 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, which effectively improves the structural strength of the support body.

[0284] In addition, if the number of components of the control mechanism increases or the operation becomes complicated, for example, the number of transmission parts and drive sleeves increases, the rigid strip can be extended axially accordingly to meet the installation requirements of the excess transmission parts and drive sleeves. The installation method between each transmission part and the support body, and between each drive sleeve and the support body is the same, realizing modular installation without sacrificing its own structural strength to meet the installation requirements.

[0285] In one embodiment, the length of the two rigid bars 333 accounts for at least 75% of the total length of the control handle 3, wherein the lengths of the two rigid bars 333 are the lengths of the two ends along the axial direction, and the total length of the control handle is the control handle in a fully extended state, that is, starting from the distal end surface of the aforementioned first drive sleeve 351 and ending at the proximal end surface of the force-applying component 355 in the following embodiment.

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

[0287] In one embodiment, the distal end of the rigid bar 333 extends into the telescopic assembly 38, for example, the distal end of the rigid bar 333 extends close to the head stage.

[0288] In another embodiment, the catheter assembly 4 includes a first group and a second group of movable sleeves from the outside to the inside, the control handle 3 includes a first handle 3100 and a second handle 3200, the first handle 3100 is used to connect the first group, and the second handle 3200 is used to connect the second group. The first handle 3100 and the second handle 3200 both include a support body 3300, and each support body 3300 includes two rigid bars 333 arranged side by side. The first handle 3100 and the second handle 3200 can share the same support body (such as Fig.46 ), or the first handle 3100 and the second handle 3200 do not share a support body. The first handle 3100 and the second handle 3200 are far away from each other and the longest distance corresponds to the control handle fully extended state.

[0289] In one embodiment, the control handle 3 includes a mounting seat 360 connected and fixed to the two rigid bars 333, and the drive sleeve 350 is embedded in the rigid bars 333 and rotates with the mounting seat 360. The mounting seat 360 provides a mounting base for the drive sleeve, while keeping the two rigid bars relatively fixed. The present application also provides a delivery system, including a catheter assembly with an artificial implant loaded at the distal end, a control handle connected to the proximal end of the catheter assembly to control the catheter assembly, and a catheter sheath 70 of the above embodiment. The catheter assembly can be inserted into the tube body of the catheter sheath via a hemostatic valve, and the specific structure of the catheter assembly and the control handle can adopt the existing technology. In addition, since the deformation section can assist in the recovery of the artificial implant after switching to the expanded state, the structure of the catheter assembly can be further simplified. For example, the outermost pipe can be omitted relative to the conventional catheter assembly.

[0290] The length of the catheter sheath of the present application can reach a more distant surgical site, for example, the length of the tube body extends to the ascending aorta, constructing a longer channel to facilitate the delivery of the catheter assembly and the artificial implant.

[0291] The following mainly provides other implementations for the structure of the lock and the base, and the working principle can be combined with the above embodiments, and the proximal handle control can be combined with conventional technology or the above embodiments.

[0292] In one embodiment, another arrangement of the lock is provided, such as Fig.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, a first opening 1031 communicating with the first cavity 103 on the proximal side of the base 10, and a second opening 1033 communicating with the first cavity 103 on the outer peripheral surface of the base 10;

[0293] like Fig.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 Fig.50a , Fig.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 element 13 moves.

[0295] In one embodiment, if Fig.49 The control mechanism also includes a third shaft 25 fixedly connected to the base 10 , the third shaft 25 extends proximally 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 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 Fig.50a , Fig.50b The rib 1035 in the middle. The positioning portion 131 is arranged along a first direction (eg Fig.51 When the free end 111 moves in the middle X), it 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 (such as ribs 1035a and ribs 1035b, etc.) are provided with locking holes 105. The positioning portion 131 is rotated through in sequence and provides a certain movement guide. During the process of the locking element rotating and inserting into each locking hole, the head end 1313 eventually abuts against the side wall 1034 of one of the ribs 1035, or is placed in the corresponding locking hole, playing a role of limiting.

[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 respectively provided with a guide groove 1039 for the positioning portion 131 to extend. The axial penetration 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 inserted and positioned, and the locking member 13 is inserted into the first locking hole 105c (such as Fig.52a In one embodiment, the groove depth of the guide groove corresponding to each rib is ( Fig.52b The H) in the figure are different, which satisfies the rotation guide of the spiral positioning part 131.

[0300] See also Fig.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 as a whole forms a chamfered or rounded structure on the distal side of the base, which serves as a guide when the artificial implant is folded.

[0301] In combination with the rotation characteristics of the lock and the circumferential distribution of each pull wire, the positioning part 131 is in the shape of a rod, which can be a straight rod or a curved rod, and there is only one of them and it matches with the free ends 111 of all the pull wires 11. The axial dimension change of the control mechanism is eliminated, and the original function of the lock to match with the pull wires one by one is retained.

[0302] In one embodiment, the base 10 is provided with a locking hole 105, and the opening of the locking hole 105 faces the circumference of the base 10. The positioning portion 131 has a curved shape and extends around the axis of the base, and the positioning portion 131 is inserted into or separated from the locking hole 105 as the locking element 13 rotates. The curvature can make full use of the circumferential space, maintain the necessary length of the locking element, and realize the control of the free ends of all the pull wires with the same locking element.

[0303] like Fig.53 At least a part of the lock 13 is a connecting portion 135 in the first cavity 103, and the control mechanism further includes a first shaft 21 in transmission cooperation with the connecting portion 135 to drive the lock 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 to the free end 111, and the control end 113 can move relative to the base 10. The control mechanism also includes a second shaft 23 connected to the control end 113, and the second shaft 23 is tubular and movably sleeved outside the first shaft 21. The movement of the second shaft 23 drives the pull wire 11 to act on the artificial implant to gradually shrink or expand.

[0305] In some embodiments, the positioning portion 131 includes at least one arc-shaped structure that matches the base, for example Figure 53 to Figure 55 The positioning portion 131 is a spiral structure, and the spiral structure is wound at least once. For example, the spiral structure is a multi-turn structure, and the turns are arranged along the axial direction (circumferential direction of the base). The generatrix of the spiral structure can be an oblique line (away from or close to the axis of the base) or a straight line. For example, when it is a straight line, it can avoid increasing the radial dimension or reducing the matching space between the connecting portion 135 and the first shaft 21.

[0306] In this embodiment, the head end 1313 of the positioning portion 131 cooperates 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 distal end of the connecting portion 135. The connection method can be direct welding of the end, or welding and fixing after partial overlap.

[0307] The connecting portion 135 is tubular, and other components are inserted into the interior thereof, such as 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 wound around the outer circumference of the connecting portion 135. The connecting portion 135 and the positioning portion 131 are located in the first cavity 103 near the end 1311 and are welded and fixed to each other.

[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] like Figure 53 to Figure 55 In one embodiment, the positioning portion 131 is a spiral structure with multiple turns, and there is an axial gap between adjacent turns. The space surrounded by the spiral structure is an internal space 1317. At least one section of the pull wire 11 is a detour section 117. In the first state, the detour section 117 is in the internal space 1317, and both ends of the detour section 117 extend outside the internal space 1317 through the corresponding axial gap. The detour section 117 and the positioning portion 131 form a force point (first force point), and the free end 111 is sleeved to a circle 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 shrink.

[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 Fig.54a For more than two turns, or for example Fig.54b It is roughly one and a half circles.

[0311] In the first state, the pull wire 11 extends from the control end 113 to the distal end to the outside of the positioning portion 131, bends to the inside of the positioning portion 131 through the second axial gap 1315a, and then extends from the second axial gap 1315a to the first axial gap 1315b at the distal end, passes through the first axial gap from the inside to the outside, bends to the outside of the positioning portion 131, and after passing through the artificial implant, the free end 111 is sleeved on the positioning portion 131. The detour section 117 is located between the first axial gap 1315b and the second axial gap 1315a, wherein the portion of the pull wire 11 extending from the control end 113 to the second axial gap 1315a is located between the positioning portion 131 and the base 10, as far away from the first shaft 21 as possible, to reduce the influence on the matching between the first shaft 21 and the connecting portion 135, and to facilitate the fixed connection between the connecting portion 135 and the positioning portion 131.

[0312] In another embodiment, the present application further 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] The intervening component 24 includes a first intervening component 241 and a second intervening component 242;

[0314] The 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] The linkage structure includes two selectively linked matching parts 271 , one of which is fixed to the second intervening component 242 , and the other is fixed to the transmission component 22 . The linkage state of the two matching parts is switched during the movement of the transmission component 22 .

[0317] The two matching parts are in a linkage state, driving the second intervening component 242 to rotate or move linearly. For example, when the transmission component 22 slides along the axial direction, the two matching parts enter or release the linkage state; Fig.56a , the two matching parts 271 are in a released linkage state, and the transmission component 22 slides axially so that the two matching parts 271 switch to Fig.56b In the linkage state, the transmission component 22 can drive the second intervention component 242 to rotate.

[0318] When the transmission component 22 rotates, the two matching parts enter or release the linkage state; Fig.57a , the two matching parts 271 are in a released linkage state, and the transmission component 22 rotates so that the two matching parts 271 switch to Fig.57b In the linkage state, the transmission component 22 can drive the second intervention component 242 to slide.

[0319] The two matching parts are linkage keys and linkage grooves that can be axially slidably separated, and the linkage keys are rotated and linked to each other when inserted into the linkage grooves. The two matching parts can also be linkage keys and linkage grooves that can be relatively rotated and separated, and the linkage keys are axially linked to each other when inserted into the linkage grooves. There are multiple linkage keys, and a part of one of the intervening components is tubular, and multiple linkage keys are arranged along the circumference of the tubular part, and correspondingly, there are multiple linkage grooves.

[0320] In the figure, along the axial direction, the first intervention component 241 is located on one side (proximal side) of the second intervention component 242. In certain initial or linkage states, the first intervention component 241 and the second intervention component 242 may 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, used for an artificial implant (e.g., an artificial heart valve) before load release;

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

[0324] A base, connected to the artificial heart valve before release and axially limited to each other;

[0325] A lock for confining the artificial heart valve to the base before release;

[0326] A balloon body, which carries an artificial heart valve and can expand the artificial heart valve;

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

[0328] See also Figure 58 to Figure 60b In combination with the lock 13 structure described above, in one embodiment, the lock 13 is used as the second intervening component, and the first shaft 21 is used as the first intervening component. At least a portion of the lock 13 is a connecting portion 135, and the first shaft 21 is in transmission cooperation with the connecting portion 135 and is used to drive the lock 13 to rotate relative to the base 10; the connecting portion 135 is tubular, and the wall of the tube has a rotation linkage structure that cooperates with the distal end of the first shaft. When the first shaft 21 moves axially relative to the connecting portion 135, the rotation linkage structure is separated or combined. Among them, the connecting portion 135 is located inside the base 10, which is conducive to combining with the first shaft 21 in the radial space.

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

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

[0331] The linkage groove 2111 cooperates with the linkage key 1352 and is disposed on the other of the connecting portion 135 and the first shaft 21 and is open to the end surface of the other. Fig.60a , Fig.60b The linkage key 1352 is provided on the connecting portion 135 (for example, at the proximal end or the distal end of the connecting portion 135), and the linkage groove 2111 is provided on the first shaft 21 and opens toward the distal end, and the linkage state is switched by sliding along the axial direction. The rotation linkage between the two is manifested in that in the circumferential direction, the side wall of the linkage groove 2111 abuts against the side wall of the linkage key 1352 (for example, Fig.61 ).

[0332] Preferably, Fig.62 The notch of 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. Fig.60a , Fig.60b and Fig.62 A pipe fitting 40 extending out of the base is fixed to the distal end of the first shaft 21 , and the linkage key 1352 is sleeved and abutted against the outer periphery of the pipe fitting 40 , maintaining the radial positioning between the locking member 13 and the base 10 , and facilitating the insertion into the linkage groove 2111 .

[0333] In one embodiment, if Fig.62 The tube wall of the connecting portion 135 is partially deformed to form a linkage key 1352. An escape zone 1353 is formed outside the linkage key 1352. The escape zone 1353 exists 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 escape zone 1353, which facilitates the insertion of the pull wire 11.

[0334] The specific formation method of the linkage key 1352 is as follows: Fig.58 The wall of the connecting portion 135 is provided with a pair of cutouts 1355 near the proximal end surface, and the portion between the same pair of cutouts 1355 is radially folded inward to form a linkage key 1352. The connecting portion 135 is a cylindrical structure, and the linkage key 1352 is a sheet. In one embodiment, the linkage key 1352 is distributed at 2 to 4 locations along the circumferential direction. For example Fig.58 , there are two linkage keys 1352. In another embodiment, another structure of the lock is provided, and the handle part can adopt other embodiments in the text, see Figure 63 to Figure 67 The present application provides a control mechanism for an artificial implant, including a base 10, a pull wire 11 and a locking member 13, wherein the base 10 has a relative distal end 32 and a proximal end 31, and an axial direction extending between the distal end 32 and the proximal end 31, and 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 without special instructions.

[0335] The base 10 is provided with a plurality of locking holes 105 which are axially staggered with each other. The pull wire 11 has a free end 111 which can be passed through or detached from the artificial implant 400. The free end 111 is the end of the pull wire 11 that first passes through and finally detaches from the artificial implant 400, and can also be understood as the farthest end of the pull wire 11 when it is straightened. The pull wire 11 also has a control end 113 relative to the free end 111, which can also be understood as the closest end of the pull wire 11 when it is straightened. The control end 113 can be directly fixed to the base 10, or can be extended proximally and controllably. There is an area between adjacent locking holes 105 for the free end 111 of the pull wire 11 to be combined with the locking element 13. The locking element 13 is rotatably matched with the base 10. The locking element 13 enters or moves out of the locking hole 105 during the rotation process to respectively lock and unlock the free end 111 of the pull wire 11 (hereinafter referred to as release).

[0336] Specifically, the free end 111 of the pull wire 11 has a first state (eg, Fig.63 ), and the second state where the locking member 13 is released and the restriction is released (such as Fig.64 ); 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 cooperates 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 or the base 10; in this state, the pull wire 11 is always connected to the artificial implant 400, and the expansion process (i.e., the degree of expansion) 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. If necessary, the pull wire 11 can also be used to recycle the artificial implant. For example, when the pull wire 11 is 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 separated from the base 10. At this time, the free end 111 can be understood to be released. After the pull wire 11 is released and separated from the artificial implant, the control end 113 is driven to make the pull wire 11 move toward the proximal end to retract the pull wire 11, for example, to reduce the length exposed to the periphery of the base, preferably completely stored in the base. After the pull wire 11 is released, the interconnection relationship between the artificial implant and the control mechanism is correspondingly released, and then the control mechanism can be withdrawn outside the body as a whole, leaving the artificial implant at a predetermined position in the body.

[0338] When the locking element 13, the base 10 and the pull wire 11 are preassembled in vitro, the pull wire 11 is inserted from the proximal end of the base, and then extends from the distal end or the side wall of the base to pass through the artificial implant and then is combined with the locking element 13. For the combination of the pull wire 11 and the locking element 13, after the free end 111 of the pull wire 11 is first combined with the locking element 13 in the corresponding area of ​​the base 10 and is in the first state, the locking element 13 continues to rotate to enter the next locking hole 105, closing the channel for the pull wire 11 to escape from the locking element 13.

[0339] Combination Figure 63 to Figure 65 In this embodiment, the multiple locking holes 105 of the base 10 are arranged axially, that is, the free ends 111 of each pull wire 11 and the combined positions with the base 10 are staggered axially, which reduces the spatial interference between the pull wires 11 and is beneficial to the assembly of the pull wires, the base and the lock, as well as the movement between the pull wires.

[0340] The shape of the artificial implant 400 is roughly a cylindrical structure, and the multiple locking holes 105 are arranged in sequence along the circumference of the base, so that the pull wires 11 are arranged in the circumference and connected to the various positions of the artificial implant 400 in the circumference, so as to keep the circumferential force of the artificial implant 400 uniform, and keep the length of each pull wire 11 basically consistent, which is conducive to the unified control of the length of all pull wires 11 exposed outside the base. And the spatial distance between each pull wire 11 is enlarged, which further facilitates assembly and reduces mutual interference. In one embodiment, the axial positions of the multiple locking holes 105 are different. Specifically, the multiple locking holes 105 are arranged along a spiral line, and the spiral line extends spirally around the axis of the base. When the locking element 13 rotates around the axis of the base, its rotation path is restricted by the locking hole 105, so that it enters each locking hole 105 in sequence and moves along the axial direction of the base. The axial displacement can reduce or eliminate the axial protrusion of the locking element 13 relative to the base 10. The spiral line arrangement allows the locking holes 105 at different positions in the circumferential direction to be staggered in the axial direction, reducing the spatial interference between the pull wires 11, optimizing the overall warp size, and further highlighting the synergy between the base structure and the movement characteristics of the lock.

[0341] See also Figures 66 to 80 The present application also provides a control mechanism for an artificial implant, including a base 10, a pull wire 11 and a lock 13. The pull wire 11 and the lock 13 refer to the above-mentioned embodiment. The base 10 includes a plurality of parts fixed to each other, wherein two parts are combined at the joint to form a lock hole 105. In this embodiment, the lock hole 105 is formed by the cooperation of two parts. The two parts can be processed independently and the appropriate materials can be selected, thereby eliminating the conventional punching operation and reducing the overall processing difficulty of the base 10.

[0342] In one embodiment, the base 10 includes an outer sleeve 170 and an inner core tube 180 which are nested and fixed inside and outside, and the outer sleeve 170 and the inner core tube 180 are surrounded to 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 tube 180 cooperating with each other, and after the outer sleeve 170 and the inner core tube 180 are assembled, a complete locking hole 105 is formed at the joint 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 locking hole 105 is continuous, that is, the locking hole is closed in its own circumferential direction, a portion of the locking 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 tube 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, at least to facilitate the entry and exit of the lock, such as circular, elliptical, arched, sealed U-shaped, etc., and can also be selected to correspond to the cross-sectional shape of the lock. The outer sleeve 170 and the inner core tube 180 can each provide a part of the edge of the lock hole 105, such as substantially evenly divided or one provides most of it.

[0347] For example, the cross-sectional shape of the lock hole 105 is a sealed U-shaped, the outer sleeve 170 provides a transverse portion of the seal, and the inner core tube 180 provides a U-shaped portion; for another example, the cross-sectional shape of the lock hole 105 is an arch, the outer sleeve 170 provides a chord portion, and the inner core tube 180 provides an arc portion. The outer sleeve 170 and the inner core tube 180 can be integrally nested or partially nested. The lock hole 105 can be between the outer sleeve 170 and the inner core tube 180 in the radial direction, or it can be a step structure between the outer sleeve 170 and the inner core tube 180 that is opposed in the axial direction (or with a certain angle), 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 surface of the outer sleeve 170 are axially abutted against each other, and the locking hole 105 is located at the abutting portion.

[0349] Another example Fig.79 and Fig.80 The step structure is located on the inner wall of the outer sleeve 170, the end surface or the outer periphery of the inner core tube 180 (also with the step structure) abuts against each other in the axial direction, and the locking hole 105 is located at the abutting position.

[0350] Key References Fig.72 In one embodiment, the control mechanism further includes three shafts, namely, a first shaft 21, a second shaft 23 and a third shaft 25 which are slidably sleeved in sequence from the inside to the 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 element 13 is connected to the distal end of the first shaft 21. The base 10 is axially penetrated and a first cavity 181 is formed inside the base 10, 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 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 has 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 proximally 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 an artificial implant.

[0352] Re-read Figures 66 to 85 , there are multiple lock holes 105 and each lock hole 105 extends in the direction of the spiral line, and the lock element 13 is inserted into or separated from each lock hole 105 in sequence. In one embodiment, the lock hole 105 is compared with the second opening 171, and the intersection is understood as the second opening 171 extending radially along the base to form a first channel, and the lock hole 105 extends in the direction of the spiral line to form a second channel, and the two channels intersect and have an intersection (that is, the spiral line intersects at the second opening 171). It can also be understood that all the lock holes 105 are directly or indirectly connected to each other through the second opening 171. The extension path of the pull wire 11 passes through the intersection, and the lock element 13 enters and exits the lock hole 105 at the intersection to combine with the pull wire 11.

[0353] Combined with the specific structure of the base 10, the cross-sectional profile of the locking hole 105 at the remaining positions of the base 10 except the second opening 171 can be regarded as circumferentially closed (i.e., a complete locking hole), while the cross-sectional profile of the locking hole 105 at the second opening (or the intersection) is incomplete. At this time, the locking hole 105 has an open mouth, and the locking element 13 passes through the open mouth during rotation to enter and exit the complete locking hole 105.

[0354] like Fig.74 The second opening 171 of the inner core barrel 180 may be provided with a flaring structure radially outward, so as to facilitate the insertion of the free end 111 of the pull wire 11 during loading, and also facilitate the operation of the matching and guiding tools.

[0355] In one embodiment, the inner core tube 180 is an axially through structure, and its interior serves as a first cavity 181. According to the assembly relationship between the inner core tube 180 and the outer sleeve 170, the outer wall of the inner core tube 180 and the side wall of the outer sleeve 170 are provided with a second opening 171. The opening sizes of the second openings 171 of the two are not necessarily the same, as long as the pull wire 11 can pass through. There are multiple pull wires 11, and multiple corresponding second openings 171 are arranged at intervals along the circumference of the base. The opening direction of the lock hole 105 is the circumference of the base. In the first state, the free end 111 of the pull wire 11 extends out of the base 10 through the corresponding second opening 171, passes through the artificial implant 400, and then returns to the same second opening 171, or returns to the circumferentially adjacent second opening 171. And as Figure 72 to Figure 78 The inner wall of the outer sleeve 170 and / or the outer wall of the inner core barrel 180 is provided with a spiral groove 182 for providing the lock hole 105, and the spiral groove 182 intersects with the second opening 171. The outer peripheral surface of the inner core barrel 180 is provided with a spiral groove 182, and the spiral groove 182 provides the aforementioned spiral line. The spiral groove 182 has a notch 183 radially facing outward, and the area where the outer sleeve 170 and the inner core barrel 180 match is a straight cylinder structure. After the outer sleeve 170 and the inner core barrel 180 are assembled, the outer sleeve 170 partially closes the notch 183 to form a complete lock hole 105, which is used to limit the rotation path of the lock member 13 to prevent the lock member 13 from deviating during the rotation process. 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 arched arc portion. For a small-sized component such as the base 10, the above structural design facilitates the processing of the outer sleeve 170 and the inner core tube 180. The materials of the two can be metal or plastic. For example, the outer sleeve 170 is a tubular structure and is processed by a metal tube, and the inner core tube 180 is formed by plastic injection molding. The second opening size of the corresponding inner core tube 180 is smaller than the second opening of the outer sleeve 170. Among them, the size of the second opening includes but is not limited to the length along the axial direction of the base, and the width extending around the axial direction of the base. In addition, compared with the existing punching processing method, the processing accuracy of the spiral groove 182 is also improved, and the rotation smoothness of the lock 13 is correspondingly improved.

[0356] In one embodiment, the proximal side of the outer sleeve 170 is an extension section 172 that crosses the inner core tube 180, and the extension section 172 is used to connect the third shaft 25 extending toward the proximal end. A mutually matching positioning structure is provided between the outer sleeve 170 and the inner core tube 180 to keep the two relatively fixed. In conjunction with the accompanying drawings, the positioning structure includes a positioning groove 184 arranged outside the inner core tube 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 formed by stamping the side wall of the outer sleeve 170.

[0357] The outer sleeve 170 is a tubular structure, and the third shaft 25 is a tube. The third shaft 25 and the extension section 172 are overlapped and connected with each other, such as being fused or bonded to each other. In one embodiment, the side wall of the extension section 172 has a connecting hole 173, and an adhesive can be added into the connecting hole 173 to improve the connection strength between the two and avoid the increase of the radial size of the two after the connection.

[0358] In one embodiment, the helix is ​​a cylindrical helix, a conical helix or partly a conical helix. Preferably, the helix is ​​a cylindrical helix, and the corresponding outer sleeve 170 and inner core sleeve 180 are substantially straight cylinder structures.

[0359] In one embodiment, the spiral groove 182 extends to open at the distal end surface of the inner core tube 180 , and the spiral groove 182 has a guiding slope 185 at the open portion of the distal end surface of the inner core tube 180 to guide the locking element 13 to be assembled into the spiral groove 182 .

[0360] See also Figure 81 to Figure 85 In one embodiment, the lock 13 has a positioning portion 131 that enters or moves out of the lock hole 105 during rotation. The positioning portion 131 is a spiral structure that matches the spiral line to improve the smoothness of rotation. The spiral structure is coiled at least once, for example, the spiral structure is a multi-turn structure, such as 4 to 5 turns in the figure, and the turns are arranged along the axial direction of the base. The extension path of the spiral structure is a cylindrical spiral, a conical spiral or a partial conical spiral. The connecting portion 134 is movably sleeved on 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 movable relative to the first shaft 21 in the axial direction. In actual use, the first shaft 21 slides axially along the base and separates or combines with the connecting portion 134. After the first shaft 21 is axially relatively 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 13 to enter or escape from 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 locking element 13 is released. The specific coordination and control relationship between the first shaft 21 and the locking element 13 is referred to the following embodiment.

[0361] The lock 13 has two rotation directions: an insertion direction and a withdrawal direction. In one embodiment, a limiting mechanism for limiting the rotation of the lock 13 in the insertion direction is provided between the lock 13 and the base 10. Specifically, during the rotation of the lock 13, when the limiting mechanism takes effect, the lock 13 is limited to continue rotating in the insertion direction.

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

[0364] In one embodiment, the connecting portion 134 is a tubular shape extending in equal diameter or at least radially expanding 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, and then passes through the second opening 171 of the inner core tube 180 and the outer sleeve 170 in sequence to extend out of the base, passes through the artificial implant 400, and then is wound back to the corresponding second opening 171, and at the same time, the locking member 13 is rotated to insert into the corresponding locking hole in sequence and engage with the corresponding pull wire 11. Then, the length of the pull wire 11 exposed outside the base 10 is contracted to pull the artificial implant 400 to deform radially close to 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, and the control end 113 of each pull wire 11 can be controlled independently or moved synchronously. The positions where the pull wires 11 interact 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 Fig.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 winding around 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 can be indirectly transmitted through an intermediate piece to reduce the risk of multiple pull wires 11 being intertwined with each other, that is, Fig.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 also Figure 85 to Figure 88In combination with the lock 13 structure described above, in one embodiment, at least a portion of the lock 13 is a connection portion 134, and the first shaft 21 and the connection portion 134 are selectively matched through a linkage assembly and used to drive the lock 13 to rotate relative to the base 10. The two matching parts are a linkage key and a linkage groove, and the linkage key 1341 is radially protruded on one of the connection portion 134 and the first shaft 21; the linkage groove 2111 matches the linkage key 1341 and is set on the other of the connection portion 134 and the first shaft 21, and the linkage key 1341 and the linkage groove 2111 are open to the end surface of the one in which they are located. In the figure, the linkage key 1341 is set at the far end of the connection portion 134, and the linkage groove 2111 is set on the loading section 211. The rotation linkage between the two is manifested in that the side wall of the linkage groove 2111 abuts against the side wall of the linkage key 1341 in the circumferential direction. The connection portion 134 is a cylindrical structure, and the linkage key 1341 is a sheet. In one embodiment, the linkage keys 1341 are distributed at 2 to 4 locations along the circumferential direction, for example, there are 2 linkage keys 1341 .

[0370] Preferably, the notch of the linkage slot 2111 is provided with a flaring structure for guiding the insertion of the linkage key 1341 , and the distal end face of the linkage key 1341 is provided with a closing structure for guiding the insertion of the notch, so as to facilitate the combination of the linkage key 1341 and the linkage slot 2111 .

[0371] The loading section 211 is nested with the connecting portion 134 in the combined state, and a support member 212 is provided on the inner periphery of the loading section 211. The support member 212 is fixed to the distal end of the first shaft 21, and a matching portion (i.e., a linkage groove) is provided on the support member 212. A limiting structure is provided between the support member 212 and the loading section 211 to limit the axial separation of the two.

[0372] The loading section 211 comprises a guide head 215 located at the distal end and connected to the first shaft 21 , and a loading portion 216 connected to the guide head 215 for accommodating the distal end of the artificial implant. The support member 212 is disposed in the guide head 215 .

[0373] The locking element will move distally during the rotation unlocking process. In one embodiment, when the loading section 211 and the locking element 13 are in the combined state, the linkage key and the linkage groove have an axial gap L1 in the axial direction for the connection part to move distally. Similarly, the proximal end surface of the guide head has the same axial gap L1 as the above from the positioning part 131. The axial gap L1 is greater than the movement amount of the locking element 13 moving distally.

[0374] See also Fig.89, one embodiment of the present application also provides an artificial implant loading method based on a wire control method, comprising: providing a control mechanism of the aforementioned embodiment, in which the free end of the pull wire passes through the proximal end of the artificial implant, and then combines with the locking element and is bound to the base by the locking element; the pull wire has a control end opposite to the free end, and the control end is moved to gradually shrink the portion of the pull wire exposed outside the base and drive the proximal end of the artificial implant to deform radially; providing a sheath tube, so that the sheath tube moves from the proximal end to the distal end relative to the artificial implant on the periphery of the artificial implant until the sheath tube completely wraps the artificial implant. The specific operation is performed in vitro, firstly the free end of the pull wire is passed through the proximal end (such as an eyelet) of the artificial implant, and then the free end is guided and extended into the locking area of ​​the base through an instrument (such as a wire holding device 500, the distal end of the wire holding device 500 has two fork arms 522 arranged side by side). The first shaft is driven to move with the loading section toward the proximal end to complete the combination with the locking element, and at this time the loading section is located on the radial inner side of the artificial implant. Then the first shaft is driven to rotate, thereby driving the locking element to rotate through the free end and enter the locking hole of the base to complete the binding of the pull wire. The first shaft and the loading section are pushed to the distal end until the loading section exits the artificial implant, and the control end of the pull wire is driven to move toward 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 an instrument (such as a crimper), driving the loading section to move proximally and wrap around the distal end of the inner frame, and then making the artificial implant and the sheath move relative to each other, for example, driving other components outside the sheath to move proximally relative to the sheath, or pushing the sheath toward the distal end until the sheath completely wraps around the artificial implant.

[0376] The pull wire, the artificial implant and the control mechanism are pre-installed. An embodiment of the present application further provides an artificial implant pre-installation method based on a wire control method, comprising: providing any of the above-mentioned control mechanisms, in which the free end of the pull wire passes through the proximal end of the artificial implant; as shown in Figures 56 and 57, the free end 111 of the pull wire 11 has a wire loop and two support points 118, which can be supported by two fork arms 522, and the mounting section 119 is placed between the support points 118. The mounting section 119 is placed in the locking area of ​​the base 10 so that the wire is placed around the movement path of the locking element 13. This operation can be completed using a wire holding device 500; the locking element 13 is driven to rotate and move along its own movement path, pass through the wire loop, and then be inserted into the locking hole of the base to restrain the free end. This operation refers to the step of combining the pull wire and the locking element in the aforementioned artificial implant loading method.

[0377] The technical features of the above embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification. When the technical features in different embodiments are embodied in the same figure, it can be regarded that the figure also discloses the combination examples of the various embodiments involved.

[0378] The above embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present application, and these all belong to 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 lock hole; A pull wire having a free end that can be passed around or detached from the artificial implant; The locking element is rotatably matched with the base, and the locking element enters or moves out of the locking hole during rotation to lock or release the free end of the pull wire.

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 part 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 into the ring, and when the free end is in a second state, the positioning portion withdraws from 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, characterized in that: 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 turn.

5. The control mechanism of the artificial implant according to claim 1, characterized in that: The base comprises an outer sleeve and an inner core sleeve which are nested and fixed inside and outside, and the locking hole is arranged between the outer sleeve and the inner core sleeve in radial direction.

6. The control mechanism of the artificial implant according to claim 5, 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, 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, the plurality of lock holes are arranged along a spiral line, the spiral line intersects at the second opening, and all the lock holes are directly or indirectly connected to each other through the second opening.

7. The control mechanism of the artificial implant according to claim 6, 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 locking hole, and the spiral groove intersects at the second opening.

8. A locking mechanism for connecting an artificial implant to a delivery system, characterized in that: include: A first shaft, a loading section is fixed at the distal end thereof, the loading section is open toward the proximal end and is used to accommodate the distal end portion of the artificial implant; A pull wire having a free end, the free end being capable of being passed around or detached from the artificial implant; A third shaft, the sliding sleeve of which is arranged outside the first shaft; A locking assembly, wherein the artificial implant is bound to the locking assembly by the pull wire during loading, the locking assembly comprising a locking element and a base fixed to the third axis, the locking element and the base having: A mutually cooperating locking state restricts the pull wire from being separated from the artificial implant; Release the lock state of the mating to allow the pull wire to be separated from the artificial implant; A linkage assembly, acting between the first shaft and the locking element, so that the two are selectively linked; In the unlocked state, the lock element is rotatably sleeved on the outer periphery of the first shaft. In the locked state, the lock element is linked with the first shaft and rotates with the first shaft until it is combined with the base and binds the pull wire.

9. The locking mechanism for connecting an artificial implant to a delivery system according to claim 8, characterized in that: The linkage assembly includes two matching parts, one of which is connected to the loading section and the other is connected to the locking element. The loading section moves axially to make the two matching parts linked or disengaged. The two matching parts are a linkage key and a linkage groove that can be axially slidably separated, and the linkage key is rotationally linked with each other when inserted into the linkage groove.

10. 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 7, 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 supporting points, and a mounting section is between the two supporting points. The mounting section is placed in the base so that the wire is surrounded and placed in 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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