Wire holding device

Abstract

The invention discloses a wire holding device which is provided with a far end and a near end which are opposite to each other, and the wire holding device comprises an outer cylinder, a wire hanging hole is formed in the side wall of the far end part of the outer cylinder, and a handle part is arranged at the near end of the outer cylinder; the fork head is movably arranged in the outer cylinder, and a wire groove is formed in the far end of the fork head and used for pushing the wire rod placed in the wire hanging hole out of the far end of the outer cylinder; the inner shaft is movably arranged in the outer cylinder in a penetrating manner, and the far end of the inner shaft is connected with the fork head; and the operating piece is movably mounted on the handle part and is in transmission fit with the near end of the inner shaft.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a wire holding device. 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 implanting artificial implants through catheter intervention.

[0003] In interventional technology, a compressed artificial implant is loaded into the distal portion of a catheter assembly and delivered to a predetermined location. After the artificial implant is radially expanded and released, the catheter assembly is withdrawn from the body.

[0004] Regarding the connection between the artificial implant and the catheter assembly, the existing technology can adopt direct snap-fit ​​or wire control. The wire control method is to use a flexible part to restrain the artificial implant to the distal end of the catheter assembly and lock the flexible part to maintain the compression state of the artificial implant. When the artificial implant needs to be released, the lock of the flexible part is released, and the flexible part is then loosened until it is separated from the artificial implant to complete the release of the artificial implant. However, there is still room for improvement in how to conveniently and quickly load the implant based on the wire control device. Summary of the Invention

[0005] In order to optimize the control and / or processing process, the present application provides a wire holding device.

[0006] The present application provides a wire holding device having a distal end and a proximal end opposite to each other, the wire holding device comprising:

[0007] An outer tube, wherein a wire hanging hole is formed on a side wall of the outer tube at a distal end, and a handle is provided at a proximal end of the outer tube;

[0008] A fork head is movably arranged in the outer tube, and a wire groove is provided at the distal end of the fork head for pushing the wire inserted into the wire hanging hole out of the distal end of the outer tube;

[0009] an inner shaft movably disposed in the outer cylinder, and having a distal end connected to the fork;

[0010] The operating member is movably mounted on the handle and is in transmission cooperation with the proximal end of the inner shaft.

[0011] Optionally, the fork head and the inner shaft are an integral structure.

[0012] Optionally, the fork head and the inner shaft are an integral tubular structure.

[0013] Optionally, the distal end of the fork head is provided with two fork arms arranged side by side, and the wire groove is located at the distal end of each fork arm.

[0014] Optionally, along a first radial viewing angle of the inner shaft, the hanging wire hole extends from a side away from the axis toward the axis and simultaneously bends toward the distal end.

[0015] Optionally, the arrangement direction of the two fork arms is parallel to the first radial direction.

[0016] Optionally, a first anti-rotation structure that cooperates with each other is provided between the outer cylinder and the inner shaft.

[0017] Optionally, the first anti-rotation structure includes:

[0018] The guide groove extends along the axial direction of the outer cylinder and is formed on the side wall of the outer cylinder or on the inner shaft;

[0019] The guide pin extends into the guide groove and is fixed to the side wall of the inner shaft or the outer cylinder.

[0020] Optionally, the guide groove has a preset length to limit the axial travel of the inner shaft.

[0021] Optionally, the operating member and the inner shaft are coupled with each other through a press-telescopic mechanism.

[0022] Optionally, a mounting chamber is provided in the handle, the pressing and telescoping mechanism is located in the mounting chamber, and at least a portion of the operating member extends out of the mounting chamber.

[0023] Optionally, the pressing and retracting mechanism includes:

[0024] a third elastic member, acting between the inner shaft and the handle to drive the inner shaft to move proximally;

[0025] The first transmission seat is arranged in the installation chamber. The position of the operating member located in the installation chamber is provided with a gear ring structure that drives the first transmission seat to rotate. The inner wall of the installation chamber is provided with long grooves and short grooves arranged alternately along the circumferential direction. The first transmission seat pushes the inner shaft toward the distal end, and during the rotation process, the distal position of the fork head is switched by inserting the long groove or the short groove.

[0026] Optionally, a second anti-rotation mechanism that cooperates with each other is provided between the proximal end of the inner shaft and the handle.

[0027] Optionally, the second anti-rotation mechanism includes:

[0028] A fixing seat, the fixing seat is arranged at the proximal end of the inner shaft, and the fixing seat has a positioning block protruding radially outward;

[0029] The guide portion is arranged in the handle and has a positioning groove that cooperates with the positioning block.

[0030] Optionally, the outer wall of the first transmission seat is provided with ribs alternately matched with the long slots and the short slots, and the pressing and telescoping mechanism has:

[0031] In the third state, the fork is retracted toward the proximal end into the outer tube under the resetting action of the third elastic member, and the rib and the long groove cooperate with each other;

[0032] In the fourth state, the fork moves distally relative to the third state to expose the outer tube, the third elastic member is compressed, and the ribs and the short slots cooperate with each other.

[0033] Optionally, the pressing and retracting mechanism further includes:

[0034] a second transmission seat, which presses against the proximal end of the inner shaft in the axial direction;

[0035] The fourth elastic member is applied axially between the second transmission seat and the first transmission seat to drive the axial movement of the first transmission seat when the second transmission seat maintains an axial position.

[0036] Optionally, the fourth elastic member has a stiffness coefficient greater than that of the third elastic member.

[0037] Optionally, when the fork is switched to the third state, the fork moves toward the proximal end under the reset action of the third elastic member, and the first transmission seat moves toward the proximal end under the reset action of the fourth elastic member, and the rib cooperates with the long groove;

[0038] During the switching process of the fork head to the fourth state, when the operating member is pressed to cause the fork head to move distally to the extreme position, the third elastic member and the fourth elastic member are both compressed; after the release operation, the axial position of the fork head remains unchanged, and the first transmission seat moves proximally under the resetting action of the fourth elastic member, and the rib cooperates with the short slot.

[0039] Optionally, the second transmission seat and the inner shaft are an integral structure.

[0040] Optionally, a third anti-rotation mechanism is provided between the operating member and the handle to keep the two circumferentially fixed, and the third anti-rotation mechanism includes:

[0041] a rotation-stop groove, axially formed on one of the handle or the operating member;

[0042] A rotation-stopping block is arranged on the other one and matched with the rotation-stopping groove.

[0043] Optionally, the handle includes a shell and a connecting seat connected to the distal end of the shell, the distal end of the connecting seat is fixedly connected to the proximal end of the outer tube, and the proximal end of the connecting seat is threadedly connected to the distal end of the shell.

[0044] Optionally, a rotation direction of the first transmission seat relative to the housing is opposite to a loosening direction of the connecting seat relative to the housing.

[0045] The present application provides a control mechanism for an artificial implant, comprising:

[0046] The base comprises an outer sleeve and an inner core sleeve which are nested and fixed inside and outside, and a locking hole is provided between the outer sleeve and the inner core sleeve in radial direction;

[0047] a pull wire having a free end that can be threaded around or detached from the artificial implant;

[0048] A locking element is rotatably engaged with the base, and during the rotation of the locking element, the locking element enters or moves out of the locking hole to lock or release the free end of the pull wire.

[0049] Optionally, the control mechanism further includes three shafts, namely a first shaft, a second shaft and a third shaft which are slidably sleeved in sequence from the inside to the outside; the base is connected to the distal end of the third shaft, the pull wire is connected to the distal end of the second shaft, and the locking element is connected to the distal end of the first shaft.

[0050] Optionally, the base is axially through and forms a first cavity inside itself, and the first shaft extends to the distal end of the base through the first cavity.

[0051] Optionally, the base has a distal end and a proximal end opposite to each other, and an axial direction extending between the distal end and the proximal end; the proximal end side of the base has a first opening communicating with the first cavity; and the outer peripheral surface of the base has a second opening communicating with the first cavity;

[0052] The pull wire is passed through the first cavity, one end of the pull wire extends proximally out of the base through the first opening, and the other end of the pull wire, ie the free end, extends out of the base through the second opening to connect to the artificial implant.

[0053] Optionally, the locking hole intersects with the second opening, and the locking element enters and exits the locking hole at the intersection.

[0054] Optionally, the locking hole intersects with the second opening, and the locking element serves as an opening of the locking hole at the intersection to enter and exit the locking hole.

[0055] Optionally, the inner core tube is an axially through structure to provide the first cavity.

[0056] Optionally, 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.

[0057] 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 lock hole, and the spiral groove intersects with the second opening.

[0058] Optionally, the outer sleeve and the inner core sleeve are respectively made of metal or plastic.

[0059] Optionally, the proximal side of the outer sleeve is an extension section that passes over the inner core sleeve, and the extension section is used to connect a third axis extending toward the proximal end.

[0060] Optionally, the side wall of the extension section has a connecting hole for composite connection with the third shaft.

[0061] Optionally, a mutually cooperating positioning structure is provided between the outer sleeve and the inner core sleeve.

[0062] Optionally, a positioning groove is provided on the outside of the inner core tube, and a positioning block embedded in the positioning groove is provided on the inner wall of the outer sleeve.

[0063] Optionally, the side wall of the outer sleeve is locally deformed to form the positioning block.

[0064] Optionally, the spiral groove extends and opens to the distal end surface of the inner core tube.

[0065] Optionally, the spiral groove has a guiding slope at an open portion of the distal end surface of the inner core barrel to guide the locking element to be assembled into the spiral groove.

[0066] Optionally, a plurality of the second openings are arranged at intervals along the circumference of the base.

[0067] Optionally, the opening of the lock hole is oriented towards the circumference of the base.

[0068] Optionally, there are multiple locking holes, and the locking piece is inserted into or removed from each locking hole in sequence.

[0069] Optionally, 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, and when the locking element is released from engagement with the free end of the pull wire, the restriction on the artificial implant is released;

[0070] In the first state, the free end extends out of the base through the corresponding second opening, passes around the artificial implant, and then returns to the same second opening, or returns to an adjacent second opening.

[0071] Optionally, the locking element has a positioning portion that enters or moves out of the locking hole during rotation, and the positioning portion is a spiral structure.

[0072] Optionally, the helical structure is coiled at least once.

[0073] Optionally, the spiral structure is a multi-turn structure, and the turns are arranged along the axial direction.

[0074] Optionally, the extension path of the helical structure is a cylindrical helix or at least partially a conical helix.

[0075] Optionally, along the winding direction of the spiral structure, the positioning portion as a whole has an opposite end and a head end, and a connecting portion is fixed to the position where one end is located.

[0076] Optionally, the connecting portion is tubular, and the end of the positioning portion is sleeved on the outer periphery of the connecting portion or abuts against the proximal end of the connecting portion.

[0077] Optionally, the control mechanism further includes a first shaft, and the connecting portion is movably sleeved on the distal end of the first shaft and can be axially separated from the distal end of the first shaft.

[0078] Optionally, 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, and when the locking element is released from engagement with the free end of the pull wire, the restriction on the artificial implant is released;

[0079] Optionally, in the first state, a limiting mechanism is provided between the locking element and the base for limiting the rotation of the locking element along the insertion direction.

[0080] Optionally, the limiting mechanism includes a first end surface provided at the proximal end of the connecting portion, and a second end surface provided at the distal end of the base and abutting against the first end surface.

[0081] Optionally, the connecting portion is in the shape of a tube extending in equal diameter or at least expands radially outward at its proximal end, and its proximal end is fixedly connected to the positioning portion.

[0082] Optionally, the pull wire has a control end opposite to the free end, and the control end can move relative to the base. When the free end is in a first state, the length of the pull wire exposed outside the base is adjusted by operating the control end. When the free end is in a second state, the pull wire is pulled away from the artificial implant by operating the control end.

[0083] Optionally, the pull wire has a control end opposite to the free end, and there are multiple pull wires. The free ends of the pull wires move independently of each other, and the control ends of the pull wires move synchronously.

[0084] Optionally, the control mechanism further includes a second shaft, the pull wires are connected to the distal end of the second shaft, and the control ends of the pull wires are connected to the second shaft.

[0085] Optionally, the base has a locking area, the locking element has a positioning portion that enters or moves out of the locking area during rotation, and the positioning portion cooperates with the free end of the pull wire to restrict the artificial implant;

[0086] The free end has a ring. When the free end is in a first state, the positioning portion penetrates the ring. When the free end is in a second state, the positioning portion pulls out the ring.

[0087] Optionally, the ring is independently configured or formed by winding the pull wire itself.

[0088] Optionally, in the first state, the pull wire extends out of the base through the current locking area, passes through the free end sleeve of the artificial implant, and returns to the same locking area.

[0089] Optionally, the artificial implant has a spatial axial direction, one end of which is a wire-controlled end, and the wire-controlled end has an eyelet for the pull wire to pass through. The artificial implant has a relative degree of deformation according to itself:

[0090] In the retracted state, the wired control end is radially retracted close to the base;

[0091] In the expanded state, the wired end is radially expanded and relatively away from the base;

[0092] The round trip paths of the same pull wire passing through the artificial implant do not overlap.

[0093] Optionally, the holes are multiple and isolated from each other, and in the expanded state, the same pull wire passes through at least two holes.

[0094] Optionally, the round trip path of the same pull wire through the artificial implant roughly forms a triangle.

[0095] Optionally, the number of the holes is twice the number of the pull wires, and in the expanded state, the same pull wire corresponds to two holes.

[0096] The artificial implant pre-installation method based on the wire control method includes:

[0097] Providing any of the above control mechanisms, wherein the free end of the pull wire passes through the proximal end of the artificial implant;

[0098] The free end of the pull wire has a wire loop and two support points, and a mounting section is located between the two support points. The mounting section is placed in the locking area of ​​the base so that the wire is placed around the movement path of the locking element.

[0099] 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.

[0100] Optionally, the pre-installation method also includes:

[0101] The pull wire has a control end opposite to the free end, and the control end is moved so that the pull wire drives the proximal end of the artificial implant to deform and converge radially;

[0102] A sheath is provided, and the sheath moves relative to the artificial implant from the proximal end to the distal end around the artificial implant until the sheath completely covers the artificial implant.

[0103] The control mechanism of the artificial implant of the present application greatly improves the processing convenience and processing accuracy of the base, and enhances the smoothness and accuracy of the wire control. BRIEF DESCRIPTION OF THE DRAWINGS

[0104] Figure 1 This is a structural diagram of a control mechanism (locking element combined with a pull wire) according to an embodiment of the present application;

[0105] Figure 2 for Figure 1 Structural view of the middle lock and the pull wire when separated;

[0106] Figure 3 This is a schematic diagram of the assembly of a lock, a base, and a pull wire according to an embodiment of the present application;

[0107] Figure 4 This is a schematic structural diagram of a conveying system according to an embodiment of the present application;

[0108] Figure 5 for Figure 4 Enlarged view of part A in the middle;

[0109] Figure 6 for Figure 5 A partial schematic diagram after the artificial implant is removed;

[0110] Figure 7 for Figure 6 The enlarged schematic diagram of the middle C part after the pull line is combined;

[0111] Figure 8 An exploded view of a lock and a base according to an embodiment of the present application;

[0112] Figure 9 This is a front view of a lock and a base according to an embodiment of the present application;

[0113] Figure 10 for Figure 9 Partial cross-sectional view in the EE direction;

[0114] Figure 11 for Figure 10 Enlarged view of the middle F part;

[0115] Figure 12 for Figure 10 Cross-sectional view in the middle DD direction;

[0116] Figure 13 for Figure 8 Schematic diagram of the structure of the middle and outer sleeves;

[0117] Figure 14 for Figure 8 Schematic diagram of the structure of the inner core tube;

[0118] Figure 15 for Figure 14 The main view of the inner core tube;

[0119] Figure 16 for Figure 15 Cross-sectional view of the middle inner core barrel in the GG direction;

[0120] Figure 17 This is a schematic structural diagram of a base according to another embodiment of the present application;

[0121] Figure 18 This is a schematic structural diagram of a base according to another embodiment of the present application;

[0122] Figure 19 and Figure 20 This is a schematic diagram of the structure when the lock is combined with the pull wire and passes through the lock hole in sequence;

[0123] Figure 21 This is a schematic structural diagram of a lock element and an inner core barrel in an early stage of assembly according to an embodiment of the present application (the outer sleeve is removed for easier observation);

[0124] Figure 22 for Figure 21 A structural diagram from another perspective;

[0125] Figure 23 for Figure 21 Schematic diagram of the structure after the middle lock piece and inner core tube are assembled;

[0126] Figures 24A to 24I This is a schematic diagram of the operating steps for releasing an artificial implant according to an embodiment of the present application; Figure 24J and Figure 24L This is a schematic diagram of the operation steps for recovering an artificial implant according to an embodiment of the present application;

[0127] Figure 25 This is a structural diagram of a wire holding device in one embodiment of the present application;

[0128] Figure 26 for Figure 25 Enlarged view of the middle M section;

[0129] Figures 27 to 29 A schematic diagram of the steps of combining the fork arm and the pull wire in the wire holding device;

[0130] Figure 30 for Figure 29 Schematic diagram of the structure of the central wire holding device when the pull wire and the locking element are combined;

[0131] Figure 31 for Figure 25 A sectional view of the central wire holding device along the axial direction (the fork is inside the outer cylinder);

[0132] Figure 32 for Figure 25 A cross-sectional view of the central wire holding device along the axial direction (the fork extends out of the outer cylinder);

[0133] Figure 33 for Figure 31 Enlarged view of the middle N part;

[0134] Figure 34 for Figure 32 Enlarged view of the middle O part;

[0135] Figure 35 for Figure 25 Exploded view of the center line holding device;

[0136] Figure 36 for Figure 35 Structural view of the middle shell.

[0137] The reference numerals in the figures are described as follows:

[0138] 10. Base; 101. Locking hole; 170. Outer sleeve; 171. Second opening; 172. Extension section; 173. Connecting hole; 174. Positioning block;

[0139] 180, inner core barrel; 181, first cavity; 182, spiral groove; 183, notch; 184, positioning groove; 185, guide slope; 186, first opening;

[0140] 11. Pull wire; 111. Free end; 113. Control end; 114. Support point; 115. Installation section;

[0141] 13. Locking element; 131. Positioning portion; 132. End; 133. Head end; 134. Connecting portion; 1341. Linkage key;

[0142] 21. First shaft; 211. Loading section; 2111. Linkage groove; 212. Support member; 215. Guide head; 216. Loading section;

[0143] 23. Second axis; 25. Third axis; 27. Extension tube; 28. Bending adjustment piece;

[0144] 400, artificial implant; 401, wire control terminal; 403, eyelet;

[0145] 500, wire holding device; 501, proximal end; 502, distal end; 510, outer cylinder; 511, wire hanging hole; 5111, first section; 5112, second section; 513, guide groove; 520, fork; 521, wire groove; 522, fork arm; 523, first connecting line; 524, second connecting line; 530, inner shaft; 532, fixing seat; 533, positioning block; 540, operating member; 541, First guide tooth; 542, anti-rotation block; 550, handle; 551, installation chamber; 552, long groove; 553, short groove; 554, guide portion; 555, positioning groove; 556, anti-rotation groove; 557, connecting seat; 558, shell; 560, third elastic member; 570, first transmission seat; 571, rib; 572, second guide tooth; 580, second transmission seat; 590, fourth elastic member. DETAILED DESCRIPTION

[0146] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0147] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0148] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0149] In this application, the terms "first," "second," etc. are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly indicate the number or order of the technical features indicated. 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, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0150] This specification describes an artificial implant and a delivery system for delivering the artificial implant to a predetermined location. The delivery system includes a control handle and a catheter assembly, wherein the control handle can be connected to and control the catheter assembly used to perform interventional surgery. The catheter assembly includes multiple control components, and the distal ends of each control component cooperate with each other to operate the artificial implant, such as releasing, retrieving, locking the position, adjusting the spatial posture, etc. Each control component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of multiple forms. There are multiple control components, and at least two of them (for example, the proximal end) can slide relative to each other along the axial direction or rotate relative to each other around the axial direction. The force-applying component on the control handle used to operate each control component (the part that the user directly operates and contacts) can be directly fixedly transmitted to the corresponding control component, or can be transmitted by means of threads, gear racks, etc.

[0151] In the following, various improvements to 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, each embodiment can also be implemented separately or in appropriate combination.

[0152] 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 can be set on the periphery of the stent, such as anchor spikes, arms, etc. 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.

[0153] Depending on the release mode, the stent is processed using corresponding materials, such as nickel-titanium alloy with shape memory that can self-expand in the body, or stainless steel that is released by balloon expansion, 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.

[0154] Taking a self-expanding stent as an example, its release and recovery can be controlled by a sheath wrapped around the periphery of the stent. The release and recovery can be controlled accordingly by varying the location of the stent exposed to the sheath. Pull wire control can also be used, where 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 tension of the pull wire with a control handle. When the pull wire is pulled out of the stent, the stent is allowed to be fully released. Of course, the control of the pull wire is also accomplished through the various controlled components in the catheter assembly.

[0155] 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 delivery. The artificial implant is in a radially compressed state, i.e., a loaded state, when introduced. After being freed from the constraints of the catheter assembly and radially expanded in the body, it is in a released state. Unless otherwise specified, the shape of the artificial implant is understood to be in the released state, and the local deformation caused by the pressure of the surrounding tissue is not taken into account.

[0156] 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 operating the bending amplitude or direction through a control handle.

[0157] 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 side relatively farther away. Along the interventional pathway, each component has relative distal and proximal ends. 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 indicates the endpoint of the structure, or a point or area on that side, or a specific structure connected to that point or area.

[0158] See Figures 1 to 5 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. Unless otherwise specified, the proximal end, distal end and axial direction are also applicable to other components of the control mechanism, as well as the control handle and delivery system of the following embodiments.

[0159] The base 10 is provided with a plurality of locking holes 101, which are axially offset from one another. The pull wire 11 has a free end 111 that can be threaded through or detached from the artificial implant 400. The free end 111 is the first end of the pull wire 11 to pass through and the last end to detach from the artificial implant 400, and can also be understood as the farthest end of the pull wire 11 when straightened. The pull wire 11 also has a control end 113 opposite the free end 111, which can also be understood as the closest end of the pull wire 11 when straightened. The control end 113 can be directly fixed to the base 10 or extend proximally and can be controlled.

[0160] There is an area between adjacent locking holes 101 for the free end 111 of the pull wire 11 to be combined with the locking element 13. The locking element 13 rotates with the base 10. During the rotation process, the locking element 13 enters or moves out of the locking hole 101 to lock and unlock the free end 111 of the pull wire 11 respectively (hereinafter referred to as release).

[0161] Specifically, the free end 111 of the pull wire 11 has a first state (eg, locked by the locking member 13 and restricted to the base 10) Figure 1 ), and the second state where the locking member 13 is released and the restriction is lifted (eg Figure 2 ); 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 restrict 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 rate of change 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.

[0162] In the second state, free end 111 is detached from base 10. At this point, free end 111 can be considered released. After pull wire 11 is released and detached from the artificial implant, control end 113 is driven to move pull wire 11 proximally, retracting it, for example, to reduce the length exposed outside the base, preferably completely retracting it within the base. After pull wire 11 is released, the connection between the artificial implant and the control mechanism is terminated. The control mechanism can then be withdrawn from the body, leaving the artificial implant in its intended location within the body.

[0163] When the locking element 13, base 10, and pull wire 11 are pre-assembled in vitro, the pull wire 11 is inserted from the proximal end of the base, then extends from the distal end or sidewall of the base, passes through the artificial implant, and then engages with the locking element 13. To engage the pull wire 11 and the locking element 13, the free end 111 of the pull wire 11 first engages with the locking element 13 in the corresponding area of ​​the base 10 and is in the first state. The locking element 13 then continues to rotate to enter the next locking hole 101, closing the path for the pull wire 11 to escape from the locking element 13.

[0164] Combine Figures 1 to 3 In this embodiment, the multiple locking holes 101 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, reducing the spatial interference between the pull wires 11, which is beneficial to the assembly of the pull wires, the base and the lock, as well as the movement between the pull wires.

[0165] The artificial implant 400 is generally cylindrical in shape, with multiple locking holes 101 arranged sequentially along the circumference of the base. This allows the pull wires 11 to be arranged circumferentially and connected to various locations around the artificial implant 400. This maintains uniform circumferential force on the artificial implant 400 and maintains a substantially consistent length of each pull wire 11, facilitating uniform control of the length of all pull wires 11 exposed outside the base. Furthermore, the spacing between the pull wires 11 is increased, further facilitating assembly and reducing interference.

[0166] In one embodiment, the axial positions of the multiple locking holes 101 vary. Specifically, the multiple locking holes 101 are arranged along a spiral line that extends spirally around the base axis. As the locking element 13 rotates around the base axis, its rotational path is constrained by the locking holes 101, causing it to sequentially enter each locking hole 101 and undergo axial displacement along the base. This axial displacement can reduce or eliminate the axial protrusion of the locking element 13 relative to the base 10. The spiral arrangement allows locking holes 101 at different circumferential positions to be axially staggered, reducing 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 locking element.

[0167] Of course, the control mechanism of the present application and other embodiments including the control mechanism of this embodiment described below are also applicable to simulation training of interventional delivery operations performed outside the living body, where the inside of the prosthesis can also be understood as outside the living body.

[0168] See also Figures 4 to 18 The present application also provides a control mechanism for an artificial implant, comprising a base 10, a pull wire 11, and a locking member 13. The pull wire 11 and locking member 13 are similar to those of the previous embodiment. The base 10 comprises multiple mutually fixed components, wherein two components are joined at a joint to form a locking hole 101. In this embodiment, the locking hole 101 is formed by the cooperation of two components. These two components can be independently processed and made of suitable materials, eliminating the need for conventional drilling operations and reducing the overall processing difficulty of the base 10.

[0169] In one embodiment, the base 10 includes an outer sleeve 170 and an inner core 180 that are nested and fixed together, and the outer sleeve 170 and the inner core 180 together form a keyhole 101. It can be understood that the keyhole 101 is formed by the outer sleeve 170 and the inner core 180 cooperating with each other. After the outer sleeve 170 and the inner core 180 are assembled, a complete keyhole 101 is formed at the junction of the two.

[0170] The cross-sectional profile of the locking hole 101 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 101 .

[0171] For example, the cross-sectional profile of the lock hole 101 is continuous, that is, the lock hole is closed in its own circumferential direction, a portion of the lock hole is formed in the inner core tube 180, and at least a portion is open, while the outer sleeve 170 closes the open portion. Of course, the processing and fitting errors between the inner core tube 180 and the outer sleeve 170 are negligible.

[0172] For another example, the cross-sectional profile of the locking hole 101 is discontinuous, a portion of the locking hole is formed in the inner core cylinder 180 and has an open portion, and the open portion is partially closed by the outer sleeve 170 .

[0173] The cross-sectional shape of the lock hole 101 is not strictly limited, as long as it is convenient for the lock member to enter and exit, and can be, for example, circular, elliptical, arched, or U-shaped. It can also be selected to correspond to the cross-sectional shape of the lock member. The outer sleeve 170 and the inner core 180 can each provide a portion of the edge of the lock hole 101, for example, substantially equally or with one providing the majority.

[0174] For example, the cross-sectional shape of the lock hole 101 is a sealed U-shape, the outer sleeve 170 provides the horizontal portion of the seal, and the inner core tube 180 provides the U-shaped portion; for another example, the cross-sectional shape of the lock hole 101 is a bow-shaped, the outer sleeve 170 provides the chord portion, and the inner core tube 180 provides the arc portion.

[0175] The outer sleeve 170 and the inner core tube 180 can be nested as a whole or partially. The lock hole 101 can be between the radial direction of the outer sleeve 170 and the inner core tube 180, or can be a step structure with an axial direction (or a certain angle) between the outer sleeve 170 and the inner core tube 180, and the lock hole 101 is located on the axial step surface.

[0176] For example Figures 6 to 11 A portion of the inner core tube 180 is located outside the outer sleeve 170 and radially turned outward to form a step structure. The turned-out portion and the end face of the outer sleeve 170 are axially opposed to each other, and the locking hole 101 is located at the opposing portion.

[0177] For example Figure 17 and Figure 18 The step structure is located on the inner wall of the outer sleeve 170, and the end face or the outer periphery of the inner core tube 180 (also with a step structure) is axially opposed, and the lock hole 101 is located at the opposing portion.

[0178] Key References Figure 10 In one embodiment, the control mechanism further comprises three shafts: a first shaft 21, a second shaft 23, and a third shaft 25, which are slidably sleeved in sequence from the inside out. 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 continuous and defines a first cavity 181 therein. The first shaft 21 extends through the first cavity 181 to the distal end of the base 10, for example, further extending beyond the distal end of the base 10.

[0179] The proximal end of the base 10 has a first opening 186 communicating with the first cavity 181, and the outer peripheral surface (i.e., the circumferential sidewall) 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 proximally out of the base 10 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 connection to the artificial implant.

[0180] Re-read Figures 4 to 23 , there are multiple lock holes 101 and each lock hole 101 extends in the direction of the spiral line, and the locking element 13 is inserted into or disengaged from each lock hole 101 in sequence. In one embodiment, the lock hole 101 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 101 extends in the direction of the spiral line to form a second channel. The two channels intersect and have an intersection (that is, the spiral intersects at the second opening 171). It can also be understood that all the lock holes 101 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 locking element 13 enters and exits the lock hole 101 at the intersection to combine with the pull wire 11.

[0181] Combined with the specific structure of the base 10, the cross-sectional profile of the lock hole 101 at the remaining positions of the base 10 except the second opening 171 can be regarded as circumferentially closed (i.e., a complete lock hole), while the cross-sectional profile of the lock hole 101 at the second opening (or the intersection) is incomplete. At this time, the lock hole 101 has an open mouth, and the locking element 13 passes through the open mouth during rotation to enter and exit the complete lock hole 101.

[0182] like Figure 12 The second opening 171 of the inner core barrel 180 may be provided with a flared 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.

[0183] In one embodiment, the inner core barrel 180 is an axially through-hole structure, and its interior serves as a first cavity 181. Based on the assembly relationship between the inner core barrel 180 and the outer sleeve 170, the outer wall of the inner core barrel 180 and the side wall of the outer sleeve 170 are provided with a second opening 171, and the inner wall is provided with a first opening 181. The opening size of the second openings 171 of the inner core barrel 180 and the outer sleeve 170 is not necessarily the same, as long as the pull wire 11 can pass through.

[0184] There are multiple pull wires 11, with corresponding second openings 171 spaced apart along the circumference of the base. The opening of the keyhole 101 faces 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 to a circumferentially adjacent second opening 171.

[0185] And as Figures 10 to 16 The inner wall of the outer sleeve 170 and / or the outer wall of the inner core barrel 180 are provided with a spiral groove 182 for providing the lock hole 101, and the spiral groove 182 intersects with the second opening 171. For example, as shown in the figure, the outer circumferential 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 facing radially outward. The area where the outer sleeve 170 and the inner core barrel 180 match is a straight cylindrical 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 101, which is used to limit the rotation path of the lock element 13 and prevent the lock element 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 101, such as a U-shaped or bow-shaped arc portion.

[0186] For small-sized components such as the base 10, the above-mentioned structural design facilitates the processing of the outer sleeve 170 and the inner core barrel 180. Both can be made of metal or plastic. For example, the outer sleeve 170 is a tubular structure and is processed from a metal tube, while the inner core barrel 180 is made of plastic injection molding. The second opening of the inner core barrel 180 is smaller than the second opening of the outer sleeve 170. The dimensions of the second opening include but are 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, which correspondingly improves the smoothness of the rotation of the lock member 13.

[0187] In one embodiment, the proximal side of the outer sleeve 170 is an extension section 172 that extends beyond the inner core 180. The extension section 172 is used to connect to the third shaft 25 extending toward the proximal end. A mutually cooperating positioning structure is provided between the outer sleeve 170 and the inner core 180 to maintain the relative fixation between the two. With reference to the accompanying drawings, the positioning structure includes a positioning groove 184 provided on the exterior of the inner core 180, and a positioning block 174 provided 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.

[0188] The outer sleeve 170 is tubular, and the third shaft 25 is made of tubular material. The third shaft 25 and the extension section 172 are overlaid and connected, for example, by fusion or bonding. In one embodiment, the sidewall of the extension section 172 includes a connection hole 173. Adhesive can be added to the connection hole 173 to enhance the connection strength and prevent radial expansion of the two after connection.

[0189] In one embodiment, the helix is ​​a cylindrical helix, a conical helix, or a portion thereof is 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.

[0190] In one embodiment, the spiral groove 182 extends and opens to the distal end surface of the inner core barrel 180 . The spiral groove 182 has a guiding slope 185 at the open portion of the distal end surface of the inner core barrel 180 to guide the locking element 13 to be assembled into the spiral groove 182 .

[0191] See Figures 19 to 23 In one embodiment, the lock 13 has a positioning portion 131 that enters or moves out of the lock hole 101 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 wound at least once. For example, the spiral structure is a multi-turn structure, such as 4 to 5 turns as shown 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. Along the winding direction of the spiral structure, the positioning portion 131 has a relative end 132 (corresponding to the distal end) and a head end 133 (corresponding to the proximal end) as a whole, and a connecting portion 134 is fixed to the position where one end is located. The connecting portion 134 is a tubular structure, and the position where the end 132 of the positioning portion 131 is located is sleeved on the outer periphery of the connecting portion 134 or abuts against the proximal end of the connecting portion 134.

[0192] The connecting portion 134 is movably mounted on the distal end of the first shaft 21 and is axially separable from the distal end of the first shaft 21. Specifically, the connecting portion 134 is axially movable relative to the first shaft 21. In actual use, the first shaft 21 slides axially along the base and separates or engages with the connecting portion 134. After the first shaft 21 is axially engaged with the connecting portion 134, it drives the first shaft 21 to rotate, thereby driving the connecting portion 134 to rotate, thereby driving the locking element 13 into or out of the lock hole 101. After the connecting portion 134 is axially separated from the distal end of the first shaft 21, the first shaft 21 releases its control over the locking element 13. The specific coordination and control relationship between the first shaft 21 and the locking element 13 is described in the following embodiments.

[0193] The lock member 13 can rotate in an insertion direction and a withdrawal direction. In one embodiment, a limiting mechanism is provided between the lock member 13 and the base 10 to limit the rotation of the lock member 13 in the insertion direction. Specifically, during the rotation of the lock member 13, when the limiting mechanism is activated, the lock member 13 is restricted from further rotation in the insertion direction.

[0194] In the figure, the limiting mechanism includes a first end surface provided at the proximal end of the connecting portion, and a second end surface provided at the distal end of the base 10 and abutting against the first end surface. Specifically, the second end surface is provided on the inner core tube 180 .

[0195] For another example, the limiting mechanism includes a head end face provided on the positioning portion 131 and a third end face provided on the base 10 and abutting against the head end face. Specifically, the third end face is provided on the side wall of the second opening 171 of the inner core barrel 180 .

[0196] In one embodiment, the connecting portion 134 is in a tubular shape extending in a constant diameter or at least expands radially outward at its proximal end, and its proximal end is fixedly connected to the positioning portion 131 .

[0197] The following is a description of the assembly process of the pull wire 11, the base 10 and the lock 13 outside the body:

[0198] First, the free end 111 of the pull wire 11 enters the first cavity 181 through the first opening 186, then passes through the inner core tube 180 and the second opening 171 of the outer sleeve 170, extends out of the base, passes through the artificial implant 400, and then is rewound back to the corresponding second opening 171. At the same time, the locking member 13 is rotated to insert into the corresponding locking hole and engage the corresponding pull wire 11. The length of the pull wire 11 exposed outside the base 10 is then retracted to pull the artificial implant 400 radially toward the base 10.

[0199] In one embodiment, the artificial implant 400 is a cylindrical structure with a corresponding circumference, and a plurality of pull wires 11 are provided. The control end 113 of each pull wire 11 can be controlled independently or moved synchronously. The positions where each pull wire 11 interacts with the artificial implant 400 are arranged at intervals along the circumference of the artificial implant 400, which can improve the synchronization of the contraction and expansion of the artificial implant 400. For example Figure 5 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.

[0200] The base 10 has a locking area, which is the area where the pull wire 11 is combined with the locking member 13. For example, the area where the second opening 171 of the aforementioned base 10 is located. There are multiple locking areas, and the number can be the same as the number of pull wires 11 or twice the number of pull wires 11. In the first state, the free end 111 of the pull wire 11 extends out of the base 10 through the current locking area, and the free end 111 after passing through the artificial implant 400 returns to the same locking area, or returns to the adjacent locking area. The free end 111 of each pull wire 11 corresponds to one or two locking areas in the first state to avoid interference between the pull wires 11.

[0201] The control end 113 of each pull wire 11 can be directly extended to the control handle independently, or it can be indirectly transmitted through an intermediate piece to reduce the risk of multiple pull wires 11 being intertwined with each other, such as Figure 10 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 .

[0202] The artificial implant 400 has a spatial axial direction, one end of which is a wire control end 401, which can be either the distal end or the proximal end of the artificial implant 400. In this embodiment, the wire control end 401 is at the proximal end of the artificial implant and has a hole 403 for the pull wire to pass through.

[0203] The eyelet 403 is formed as follows:

[0204] The artificial implant includes a hollow portion forming an eyelet, and the hollow portion is a type of structural gap of the artificial implant;

[0205] Or directly punch holes to form holes;

[0206] Or it can be independently configured on an artificial implant (such as welding, etc.).

[0207] The holes 403 are multiple and isolated from each other. In the expanded state, the same pull wire 11 passes through at least two holes 403 .

[0208] In the first state, the free end 111 of the pull wire can prevent the artificial implant 400 from being completely separated from the control mechanism. However, by adjusting the length of the pull wire exposed outside the base, the artificial implant can be allowed to deform to a certain extent, or it can be understood as changing the position of the artificial implant relative to the base. Therefore, when the free end 111 of the pull wire remains in the first state, the artificial implant 400 can still have multiple states depending on its degree of deformation, such as relative:

[0209] In the expanded state, the wire control end 401 radially expands away from the base 10, and the round-trip paths of the same pull wire 11 passing through the artificial implant 400 do not overlap;

[0210] In the retracted state, the wired control terminal 401 is radially retracted and close to the base 10;

[0211] In the intermediate state, the wire control terminal 401 is between the expanded state and the retracted state.

[0212] Multiple eyelets 403 are spaced apart circumferentially. In the expanded state, a single pull wire 11 passes through at least two eyelets 403, meaning that a single pull wire 11 can act on two locations circumferentially of the control end 401. In a preferred embodiment, the number of eyelets 403 is twice the number of pull wires 11, with each pull wire 11 corresponding to two eyelets 403. This allows for synchronized contraction and expansion of the control end 401 of the artificial implant 400 at various locations along the circumference, reduces the number of pull wires, avoids entanglement and friction at the proximal ends of the pull wires, and correspondingly reduces the space required to accommodate the pull wires.

[0213] At least two stay wires are configured for the entire artificial implant 400. In addition, only one stay wire is allowed to be threaded through the same eyelet to avoid interference caused by reciprocating threading.

[0214] The round trip path of the same pull wire 11 through the artificial implant roughly forms a triangular area, that is, the round trip paths do not overlap.

[0215] In one embodiment, the outer surface of the artificial implant 400 is gold-plated, so that the artificial implant 400 is displayed more clearly on imaging equipment.

[0216] An embodiment of the present application further provides a method for controlling an artificial implant based on a wire control method, comprising:

[0217] Providing a control mechanism of the aforementioned embodiment, wherein the free end of the pull wire passes through the artificial implant and is bound to the base by the locking member;

[0218] The pull wire has a control end opposite to the free end. When the artificial implant is released, the control end moves distally, so that the portion of the pull wire exposed outside the base gradually stretches and allows the artificial implant to deform radially.

[0219] When the artificial implant is deformed to a desired extent, the fit between the locking element and the base is released and the free ends are released;

[0220] Move the control end proximally to pull the free end away from the artificial implant.

[0221] Detailed description is given with reference to the accompanying drawings:

[0222] After the artificial implant is delivered to the predetermined position in the body, the components in the sheath are first pushed distally to push the entire sheath forward or the sheath is moved proximally to expose the arm 430 and the control mechanism. At this time, the proximal end of the artificial implant is controlled by the control mechanism, and the distal end is constrained by the loading section 211.

[0223] like Figure 24A , and then push the first shaft 21 toward the distal end to release the restraint of the loading section 211 on the artificial implant, that is, the distal end of the artificial implant loses its restraint and expands radially outward, preparing to release the proximal end of the artificial implant.

[0224] like Figures 24B to 24E , keep the third axis stationary, push the second axis toward the distal end, and move the control end of the pull wire 11 toward the distal end, so that the part of the pull wire 11 exposed outside the base gradually stretches, allowing the artificial implant 400 (mainly the proximal part) to gradually expand, and the pull wire outside the base 10 will gradually stretch along the direction of the arrow until Figure 24F , the artificial implant 400 is in an expanded state (ie, the expected amplitude), and after it is confirmed that it is in accordance with the expected fit with the surrounding tissue, the pull wire can be released.

[0225] When releasing the pull line, Figures 24G to 24I , rotate the first shaft to drive the lock to rotate relative to the base, and release the restrictions of each pull wire 11, so that each free end is completely separated from the lock. Figure 24H , withdraw the second axis toward the proximal end, so that the control end of each pull wire moves toward the proximal end, so that the free end 111 is separated from the artificial implant 400; finally, Figure 24I After re-docking the loading section and the sheath, the control mechanism is withdrawn out of the body as a whole.

[0226] In addition, before the cable is unlocked, a retraction operation can be performed as needed, see Figure 24J ( Figure 24G )~ Figure 24L The corresponding operation:

[0227] The control end of the pull wire is driven proximally, thereby retracting the proximal end of the artificial implant through the pull wire, while the distal end of the artificial implant remains expanded. The first shaft is driven to move proximally, along with the loading section 211, until the loading section 211 is radially inward of the artificial implant. The artificial implant and the sheath are then moved relative to each other, for example, by driving other components outside the sheath proximally relative to the sheath, or by pushing the sheath distally until the sheath completely encloses the artificial implant.

[0228] It should be noted that the position of the axis in the figure has no limiting meaning, and the control end can be very long or very short, or the pull wire can be directly connected to the control handle for direct retraction and extension.

[0229] For the control of the pull wire, the control end of the pull wire may be extended and directly controlled by the control handle.

[0230] An embodiment of the present application further provides an artificial implant loading method implemented in a wire-controlled manner, comprising:

[0231] A control mechanism according to the aforementioned embodiment is provided, wherein the free end of the pull wire passes through the proximal end of the artificial implant, is coupled to the locking member, and is restrained to the base by the locking member;

[0232] 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;

[0233] A sheath is provided, and the sheath moves relative to the artificial implant from the proximal end to the distal end around the artificial implant until the sheath completely covers the artificial implant.

[0234] The specific operation is carried out in vitro. First, the free end of the pull wire is passed through the proximal end (such as the eyelet) of the artificial implant, and then the free end is guided by an instrument (such as the wire holding device described below) and extended into the locking area of ​​the base.

[0235] The first shaft is driven to move the loading section proximally to complete the engagement with the locking element. The loading section is now radially inward of the artificial implant. The first shaft is then driven to rotate, thereby driving the locking element to rotate through the free end into the locking hole of the base, thereby completing the binding of the pull wire.

[0236] The first shaft and the loading section are pushed distally until the loading section exits the artificial implant, and the control end of the driving wire moves proximally to compress the proximal end of the artificial implant.

[0237] 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 the artificial implant and the sheath are moved 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.

[0238] The pull wire, the artificial implant, and the control mechanism are pre-assembled. One embodiment of the present application further provides a method for pre-assembling an artificial implant based on a wire control method, comprising:

[0239] Providing any of the above control mechanisms, wherein the free end of the pull wire passes through the proximal end of the artificial implant;

[0240] like Figure 29 and Figure 30 The free end 111 of the pull wire 11 has a wire loop and two support points 114. The mounting section 115 is located between the two support points 114. The mounting section 115 is placed in the locking area of ​​the base 10 so that the wire is looped and placed on the movement path of the locking element 13. This operation can be completed using the wire holding device mentioned above.

[0241] 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 bind the free end. This operation refers to the step of combining the pulling wire and the locking element in the aforementioned artificial implant loading method.

[0242] See Figures 25 to 32 The present application also provides a wire holding device 500 (i.e., the aforementioned guiding tool) having a relative distal end 502 and a proximal end 501. The wire holding device 500 is independent of the aforementioned control handle 300, so the distal ends and proximal ends of the two are independent of each other.

[0243] The wire holding device 500 includes an outer cylinder 510, a fork 520, an inner shaft 530, and an operating member 540. The outer cylinder 510 has a wire hanging hole 511 on its sidewall at the distal end for hanging the wire 11. The proximal end of the outer cylinder 510 has a handle 550 for holding. The fork 520 is movably disposed within the outer cylinder 510. The distal end of the fork 520 has a wire groove 521 for pushing the wire (i.e., the aforementioned wire 11) inserted into the wire hanging hole 511 out of the outer cylinder 510. The inner shaft 530 is movably disposed within the outer cylinder 510, with its distal end connected to the fork 520. The operating member 540 is movably mounted on the handle 550 and is in transmission engagement with the proximal end of the inner shaft 530.

[0244] During actual use, the pull wire 11 is first hung on the wire hanging hole 511, and the operating part 540 drives the fork head 520 to move toward the distal end and acts on the pull wire 11 through the wire groove 521, and the pull wire 11 is pushed out of the distal end of the outer tube 510, so that the pull wire 11 forms a free end 111 waiting to be combined with the locking part 13.

[0245] The fork head 520 and the inner shaft 530 are an integral structure or separate structures. In this embodiment, the fork head 520 and the inner shaft 530 are an integral tubular structure.

[0246] In one embodiment, the free end 111 of the pull wire 11 is a wire loop formed by folding a single pull wire 11 in half. The distal end of the fork 520 is provided with two fork arms 522 arranged side by side, and the wire groove 521 is located at the distal end of each fork arm 522. In actual use, after the pull wire 11 is hung on the wire hanging hole 511, the fork 520 moves toward the distal end, and the two fork arms 522 act on the pull wire 11 respectively to form the required wire loop. The space between the two fork arms 522 is for the locking element 13 to pass through. For example, the positioning portion 131 of the locking element 13 is a spiral structure, and the cross-sectional size of the positioning portion 131 is smaller than the gap between the two fork arms 522.

[0247] like Figures 26 to 33 As shown, the outer cylinder 510 has an axis, and the radial direction is a direction perpendicular to the axis of the outer cylinder. In one embodiment, along the first radial perspective of the inner shaft 530, the extension path of the hanging hole 511 is:

[0248] First, it extends from the side away from the axis toward the axis, and then bends toward the distal end;

[0249] Or it extends from a side away from the axis toward the axis and bends toward the distal end. Specifically, the wire hanging hole 511 passes through the outer cylinder 510 along a first radial direction (wherein the first radial direction is parallel to the first connecting line 523 and the second connecting line 524 described below). The wire hanging hole 511 includes a first section 5111 with a smaller bending angle, and a second section 5112 with a larger bending angle, wherein the bending amplitude of the first section 5111 forms an angle α with the radial direction, the bending angle of the second section 5112 is perpendicular to the radial direction, and the connecting portion between the first section 5111 and the second section 5112 is smoothly transitioned. The opening size W1 of the first section 5111 is larger than the opening size W2 (i.e., the width size described below) of the second section 5112, so that the pull wire 11 can easily enter the first section 5111 and be guided to the second section 5112. The width dimension W2 of the second section 5112 is adapted to the wire diameter R of the pull wire 11 to limit the movement of the pull wire 11 within the second section 5112, and even to prevent the pull wire 11 from escaping the second section 5112. For example, the sidewalls of the second section 5112 can clamp the pull wire 11. Specifically, W2:R = 0.5 to 1.5, preferably W2:R = 0.8 to 1.2. W2:W1 = 2 to 2.5.

[0250] In one embodiment, the outer cylinder 510 and the fork 520 are coaxially arranged, with the two fork arms 522 arranged parallel to the first radial direction. A first line 523 connecting the wire slots 521 of the two fork arms 522 passes through the axis of the outer cylinder, while a second line 524 connecting the ends of the two second sections 5112 lies on the axis of the outer cylinder, with the first and second lines coinciding. This ensures that the pull wire 11 is positioned along the path of the wire slots 521 when the fork 520 moves distally. The wire slots 521 are open U-shaped or semicircular to facilitate engagement with the pull wire 11.

[0251] In order to ensure that the pull wire 11 is located on the moving path of the wire groove 521, in one embodiment, a first anti-rotation mechanism is provided between the outer cylinder 510 and the inner shaft 530 to cooperate with each other to keep the two fixed in the circumferential direction. The first anti-rotation mechanism includes:

[0252] The guide groove 513 extends along the axial direction of the outer cylinder and is formed on the side wall of the outer cylinder or on the inner shaft;

[0253] The guide pin extends into the guide groove 513 and is fixed to the inner shaft 530 or the side wall of the outer cylinder.

[0254] As shown in the figure, the guide groove 513 is provided on the side wall of the outer cylinder 510, and the guide pin extends radially and is fixed to the inner shaft 530 to limit the relative rotation between the outer cylinder 510 and the inner shaft 530. Furthermore, the guide groove 513 has a predetermined length to limit the axial travel of the inner shaft 530.

[0255] In another embodiment, the proximal end of the inner shaft 530 extends into the handle 550, and a second anti-rotation structure that cooperates with the proximal end of the inner shaft 530 and the handle 550 is provided. The second anti-rotation mechanism includes:

[0256] A fixed seat 532 is fixedly connected to the proximal end of the inner shaft 530, and a positioning block 533 is radially protruded outward from the fixed seat 532;

[0257] The guide portion 554 is disposed in the handle 550 and has a positioning groove 555 that cooperates with the positioning block 533 .

[0258] The first anti-rotation mechanism and the second anti-rotation mechanism can exist at the same time.

[0259] See Figures 25 to 36 The operating member 540 and the inner shaft 530 are coupled to each other through a push-and-telescopic mechanism. Specifically, the operating member 540 is driven by a push action, and the inner shaft 530 is extended and retracted relative to the outer cylinder 510, specifically extending out of and retracting into the outer cylinder 510. The handle 550 includes a mounting chamber 551, within which the push-and-telescopic mechanism is located. The operating member 540 at least partially extends out of the mounting chamber 551.

[0260] The press-to-retract mechanism includes:

[0261] The third elastic member 560 (e.g., a spring as shown in the figure) acts between the inner shaft 530 and the handle 550 to drive the inner shaft 530 to move proximally;

[0262] The first transmission seat 570 is mounted within the mounting chamber 551. The portion of the operating member 540 located within the mounting chamber 551 is equipped with a gear ring structure that drives the first transmission seat 570 in rotation. The inner wall of the mounting chamber 551 is provided with alternating long slots 552 and short slots 553 arranged circumferentially. Both the long slots 552 and short slots 553 extend axially along the thread holding device. The first transmission seat 570 pushes the inner shaft 530 distally. During rotation, the long slots 552 and short slots 553 are inserted to switch the position of the fork 520 relative to the outer cylinder 510. Specifically, the long slots 552 correspond to the fork 520 extending out of the outer cylinder 510, while the short slots 553 correspond to the fork 520 retracting into the outer cylinder 510.

[0263] Correspondingly, the outer wall of the first transmission seat 570 is provided with ribs 571 that alternately cooperate with the long slots 552 and the short slots 553. The pressing and telescopic mechanism has:

[0264] In the third state, the fork 520 retracts proximally into the outer tube under the resetting action of the third elastic member 560 , and the rib 571 and the long groove 552 cooperate with each other;

[0265] In the fourth state, the fork 520 moves distally relative to the third state to expose the outer tube 510 , the third elastic member 560 is compressed, and the rib 571 cooperates with the short slot 553 .

[0266] The press-to-retract mechanism also includes:

[0267] The second transmission seat 580 axially presses against the proximal end of the inner shaft 530 ;

[0268] The fourth elastic member 590 (eg, a cylindrical spring) is applied axially between the second transmission seat 580 and the first transmission seat 570 to drive the axial movement of the first transmission seat 570 when the second transmission seat 580 maintains its axial position.

[0269] Please refer to the figure for details. When the telescopic mechanism is switched from the third state to the fourth state:

[0270] The first transmission seat 570 cooperates with the long slot 552 (i.e., the push-telescopic mechanism is in the third state), and the pressing operating member 540 pushes the first transmission seat 570 to move distally. The force is transmitted to the second transmission seat 580 via the fourth elastic member 590, pressing the inner shaft 530 to move distally until the fork 520 extends out of the outer tube 510. During this process, the third elastic member 560 and the fourth elastic member 590 are compressed. The stiffness coefficient of the fourth elastic member is greater than that of the third elastic member. When the fork 520 moves to the extreme position, the operating member 540 is released, and the fourth elastic member 590 resets before the third elastic member 560, driving the first transmission seat 570 to move proximally and cooperate with the short slot 553. The axial position of the fork 520 remains unchanged, preventing the pull wire 11 from escaping from the wire groove 521.

[0271] Press the telescopic mechanism to switch from the fourth state to the third state:

[0272] Based on the above, the operating member 540 is pressed again, pushing the first transmission seat 570 to move toward the distal end and compressing the fourth elastic member 590 until the movement limit of the operating member 540 is reached, and the operating member 540 is released. The third elastic member 560 and the fourth elastic member 590 are both reset, driving the inner shaft 530 and the first transmission seat 570 to move toward the proximal end respectively until the rib 571 and the short groove 553 of the first transmission seat 570 are matched.

[0273] In one embodiment, the second transmission base 580 and the inner shaft 530 are an integral structure.

[0274] In one embodiment, a third anti-rotation mechanism is provided between the operating member 540 and the handle 550 to keep the two fixed in a circumferential direction. The third anti-rotation mechanism includes:

[0275] A rotation-stop groove 556 is axially defined in one of the handle 550 or the operating member 540 ;

[0276] The anti-rotation block 542 is provided on the other and cooperates with the anti-rotation groove 556. In the figure, the anti-rotation groove 556 is opened on the inner wall of the handle 550, and the anti-rotation block 542 is protruded on the outer peripheral surface of the operating member 540.

[0277] In one embodiment, the ring gear structure includes:

[0278] a first guide tooth 541 circumferentially arranged at a distal end of the operating member 540 ;

[0279] The second guide tooth 572 is arranged at the proximal end of the rib 571, and the first guide tooth 541 is a V-shaped tooth. When the rib 571 cooperates with the long groove 552 or the short groove 553, the tooth surface of the second guide tooth 572 and the first guide tooth 541 are circumferentially misaligned. When the operating member 540 moves toward the distal end, the two guide teeth cooperate with each other until the rib 571 disengages from the long groove 552 or the short groove 553. The first transmission seat 570 rotates under the action of the fourth elastic member 590 and the two guide teeth, releasing the pressure on the operating member 540. The first transmission seat 570 moves toward the proximal end under the action of the fourth elastic member 590 until the rib 571, the short groove 553 and the long groove 552 cooperate.

[0280] The handle 550 includes a housing 558 and a connecting base 557 connected to the distal end of the housing. The distal end of the connecting base 557 is fixedly connected to the proximal end of the outer tube 510, and the proximal end of the connecting base 557 is threadedly connected to the distal end of the housing 558. The aforementioned fixing base 532 is slidably mounted within the connecting base 557. The rotation direction of the first transmission base 570 relative to the housing 558 is opposite to the direction in which the connecting base 557 is loosened relative to the housing 558. This prevents the rotation of the first transmission base 570 from transmitting force and causing the connecting base 557 to rotate and loosen during operation.

[0281] The control mechanism of the artificial implant of the present application greatly improves the processing convenience and processing accuracy of the base, and enhances the smoothness and accuracy of the wire control.

[0282] The technical features of the above embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there are no conflicts in the combination of these technical features, they should be considered to be within the scope of this specification. When technical features in different embodiments are reflected in the same figure, it can be regarded as that figure also discloses the combination examples of the various embodiments involved.

[0283] The above embodiments merely illustrate several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person skilled in the art could make numerous variations and improvements without departing from the spirit of the present application, all of which fall within the scope of protection of the present application.

Claims

1. A wire holding device having opposite distal and proximal ends, characterized in that: The wire holding device comprises: An outer tube, wherein a wire hanging hole is formed on a side wall of the outer tube at a distal end, and a handle is provided at a proximal end of the outer tube; A fork head is movably arranged in the outer tube, and a wire groove is provided at the distal end of the fork head for pushing the wire inserted into the wire hanging hole out of the distal end of the outer tube; an inner shaft movably disposed in the outer cylinder, and having a distal end connected to the fork; The operating member is movably mounted on the handle and is in transmission cooperation with the proximal end of the inner shaft.

2. The wire holding device according to claim 1, characterized in that The fork head and the inner shaft are an integrated tubular structure.

3. The wire holding device according to claim 1, characterized in that The distal end of the fork head is provided with two fork arms arranged side by side, and the wire groove is located at the distal end of each fork arm.

4. The wire holding device according to claim 1, characterized in that From a first radial viewing angle along the inner shaft, the hanging wire hole extends from a side away from the axis toward the axis and simultaneously bends toward the distal end.

5. The wire holding device according to claim 1, characterized in that: A first anti-rotation structure that cooperates with each other is provided between the outer cylinder and the inner shaft.

6. The wire holding device according to claim 5, characterized in that: The first anti-rotation structure includes: The guide groove extends along the axial direction of the outer cylinder and is formed on the side wall of the outer cylinder or on the inner shaft; The guide pin extends into the guide groove and is fixed to the side wall of the inner shaft or the outer cylinder.

7. The wire holding device according to claim 6, characterized in that: The guide groove has a preset length to limit the axial travel of the inner shaft.

8. The wire holding device according to claim 1, characterized in that: The operating member and the inner shaft are matched with each other through a pressing and telescopic mechanism.

9. The wire holding device according to claim 8, characterized in that: The pressing and retracting mechanism comprises: a third elastic member, acting between the inner shaft and the handle to drive the inner shaft to move proximally; The first transmission seat is arranged in the installation chamber. The position of the operating member located in the installation chamber is provided with a gear ring structure that drives the first transmission seat to rotate. The inner wall of the installation chamber is provided with long grooves and short grooves arranged alternately along the circumferential direction. The first transmission seat pushes the inner shaft toward the distal end, and during the rotation process, the distal position of the fork head is switched by inserting the long groove or the short groove.

10. The wire holding device according to claim 1, characterized in that: A second anti-rotation mechanism is provided between the proximal end of the inner shaft and the handle, and the second anti-rotation mechanism comprises: A fixing seat, the fixing seat is arranged at the proximal end of the inner shaft, and the fixing seat has a positioning block protruding radially outward; The guide portion is arranged in the handle and has a positioning groove that cooperates with the positioning block.

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