Artificial implant control mechanism, locking mechanism, intervention conveying system, control method and loading method

Abstract

The invention discloses a control mechanism, a locking mechanism, an intervention conveying system, a control method and a loading method of an artificial implant. The control mechanism comprises a base (10), a stay wire (11) and a lock piece (13), wherein a lock hole is formed in the base (10); the stay wire (11) is provided with a free end (111) which can penetrate through or be separated from the artificial implant (60); the locking piece (13) is integrally located at the far end of the base (10), and the locking piece (13) and the base (10) are rotationally matched to lock the free end (111) of the pull wire (11). 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 (60), and is suitable for in-vivo work.

Description

Control mechanism, locking mechanism, intervention delivery system, control method and loading method of artificial implant Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a control mechanism, a locking mechanism, an interventional delivery system, a control method, and a loading 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. After the artificial implant is radially expanded and released, the catheter assembly is withdrawn from the body.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-on or wire control methods. 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 it is necessary to allow the artificial implant 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, the existing control method and control structure for the flexible part still need to be improved. Technical issues

[0005] Flexible members are typically controlled by a control handle. Conventional control handles include a support body, a transmission member movably mounted on the support body, and a driver movably mounted on the support body to drive a portion of the transmission member. The support body must balance its own structural strength with the installation of the transmission and driver members, resulting in a complex structure. This complexity is further exacerbated by the increasing sophistication of wire-controlled structures and operations, potentially sacrificing strength for ease of installation or operation. Technical Solutions

[0006] The present application provides a control mechanism for an artificial implant, which makes the control of the flexible part (including locking and unlocking) more reasonable.

[0007] The present application provides a control mechanism for an artificial implant, comprising:

[0008] The base is provided with a keyhole;

[0009] a pull wire having a free end that can be threaded around or detached from the artificial implant;

[0010] A locking element is located as a whole at the distal end of the base, and the locking element is rotatably matched with the base to lock or release the free end of the pull wire.

[0011] 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.

[0012] 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;

[0013] 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 base has a first cavity inside, a first opening communicating with the first cavity on the proximal end side of the base, and a second opening communicating with the first cavity on the outer peripheral surface of the base.

[0014] 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.

[0015] Optionally, the locking area is located at the second opening.

[0016] Optionally, a plurality of the second openings are arranged at intervals along the circumference of the base, and ribs are provided between adjacent second openings.

[0017] Optionally, all ribs converge and are fixed to each other at the distal end of the base.

[0018] Optionally, all ribs converge to form a ring structure.

[0019] Optionally, the opening of the lock hole is oriented towards the circumference of the base.

[0020] Optionally, the lock hole is provided on at least one rib.

[0021] Optionally, all ribs are provided with keyholes.

[0022] Optionally, there are multiple ribs with locking holes, and the positioning portion as a whole has opposite tail ends and head ends, and the head ends are sequentially inserted into or separated from the respective locking holes as the locking element rotates.

[0023] Optionally, there are one or more locking holes on the same rib.

[0024] Optionally, the plurality of lock holes are arranged in sequence along the extension direction of the rib.

[0025] 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;

[0026] 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 locking area corresponding to the same second opening, or returns to the locking area corresponding to the adjacent second opening.

[0027] Optionally, the free end of the pull wire is located in the current locking area in the first state, and the two ends of the positioning portion located in the current locking area are respectively inserted into the locking holes on the corresponding sides.

[0028] Optionally, a plurality of locking areas are arranged at intervals along the circumference of the base, and the positioning portion enters or moves out of each locking area in sequence as the locking element moves.

[0029] Optionally, 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;

[0030] The positioning portion has a curved shape and extends circumferentially around the base. The positioning portion is inserted into or separated from the locking hole as the locking element rotates.

[0031] Optionally, the positioning portion includes at least one arc-shaped structure that cooperates with the base.

[0032] Optionally, the positioning portion is a spiral structure.

[0033] Optionally, the helical structure is coiled at least once.

[0034] Optionally, the spiral structure is a multi-turn structure, and the turns are arranged along the axial direction.

[0035] Optionally, the extension path of the helical structure is a cylindrical helix or at least partially a conical helix.

[0036] 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.

[0037] 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.

[0038] Optionally, 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.

[0039] 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;

[0040] In the first state, a limiting mechanism is provided between the locking member and the base for limiting the rotation of the locking member along the insertion direction.

[0041] Optionally, the positioning portion as a whole has an opposite end and a head end, wherein a connecting portion is fixed to the portion where one end is located, and a positioning mechanism is provided between the connecting portion and the base to maintain the axial position of the two;

[0042] The positioning 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.

[0043] Optionally, the connecting portion is tubular with equal diameter extension or at least radially expands at its proximal end, the proximal end of which is a connecting section, the distal end of the base has an extension section, and the connecting section and the extension section are nested with each other.

[0044] 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. When the locking element is released from engagement with the free end of the pull wire, the restriction on the artificial implant is released.

[0045] 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.

[0046] 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.

[0047] Optionally, the control end of each pull wire is connected to the second shaft.

[0048] 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;

[0049] 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.

[0050] Optionally, the ring is independently configured or formed by winding the pull wire itself.

[0051] Optionally, the positioning portion is in a multi-turn spiral shape with an axial gap between adjacent turns; in the first state, the pull wire extends out of the base through the current axial gap, and the free end after winding around the artificial implant is sleeved to a turn adjacent to the current axial gap.

[0052] 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.

[0053] 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:

[0054] In the retracted state, the wired terminal is radially retracted close to the base;

[0055] In the expanded state, the wired end is radially expanded and relatively away from the base;

[0056] The round trip paths of the same pull wire passing through the artificial implant do not overlap.

[0057] 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.

[0058] Optionally, the round trip path of the same pull wire through the artificial implant roughly forms a triangle.

[0059] 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.

[0060] The present application also provides a locking mechanism for connecting an artificial implant to a delivery system, comprising:

[0061] A first shaft, having a loading section fixed at the distal end thereof, the loading section being open toward the proximal end and being used to accommodate the distal end portion of the artificial implant;

[0062] a pull wire having a free end, the free end being capable of being threaded around or detached from the artificial implant;

[0063] a third shaft, slidably sleeved on the exterior of the first shaft, a locking assembly mounted on the third shaft, the artificial implant being restrained to the locking assembly by the pull wire when loaded, the locking assembly comprising a locking member and a base, the two members having a locked state in which they cooperate with each other and a released state in which they are released from the cooperation, each state respectively restricting and allowing the pull wire to detach from the artificial implant;

[0064] The linkage assembly acts between the first shaft and the locking element to selectively link the two.

[0065] 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. The loading section can move axially to enable the two matching parts to be linked or disengaged.

[0066] Optionally, the two matching parts are a linkage key and a linkage groove that can be axially slid and separated, and the linkage key is rotated and linked with each other when inserted into the linkage groove.

[0067] Optionally, there are multiple linkage keys, which are connected to each other through a tubular component, and the multiple linkage keys are arranged circumferentially along the tubular component.

[0068] Optionally, there are multiple linkage grooves, which are connected to each other through a tubular component, and the multiple linkage grooves are arranged circumferentially along the tubular component.

[0069] Optionally, at least a portion of the locking element is a connecting portion, and the linkage key or linkage slot is provided at a distal end of the connecting portion.

[0070] Optionally, the connecting portion is located outside the base.

[0071] Optionally, the linkage groove is opened on the tube wall at the distal end of the connecting portion, and a linkage key is provided on the inner peripheral wall of the loading section.

[0072] Optionally, the slot opening of the linkage slot has a flared structure.

[0073] Optionally, the two matching parts are a linkage key and a linkage groove that can be separated by relative rotation, and the linkage key is linked to each other along the axial direction when inserted into the linkage groove.

[0074] Optionally, a support member is provided on the inner periphery of the loading section, and the support member is fixed to the distal end of the first shaft, wherein a fitting portion is provided on the support member.

[0075] Optionally, a limiting structure is provided between the support member and the loading section to limit axial separation between the two.

[0076] Optionally, the limiting structure includes a positioning piece radially protruding from the outer periphery of the support member, and a positioning groove provided on the inner peripheral surface of the loading section and cooperating with the positioning piece.

[0077] Optionally, the support member is a cylindrical structure, and a portion of the outer periphery is turned outward to form the positioning piece.

[0078] Optionally, the support member includes an outer cylinder connected to the loading section, and an inner cylinder with a fitting portion fixed to the first shaft.

[0079] Optionally, the inner cylinder and the outer cylinder are separate structures.

[0080] The present application also provides a loading structure for an artificial implant, the artificial implant comprising an inner frame, the inner frame having a plurality of arms on its periphery, each arm forming a first gap with the inner frame for accommodating native tissue, the loading structure comprising:

[0081] a first shaft, wherein the inner frame is sleeved on the outer periphery of the first shaft in a compressed state;

[0082] The loading section is tubular and fixed to the distal end of the first shaft. The loading section is open toward the proximal end. At least the distal end of the inner frame is housed in the loading section. A clearance opening is provided on the peripheral wall of the loading section, and at least a portion of the arm is located in the clearance opening.

[0083] Optionally, the outflow side of each arm is fixedly connected to the inner frame, and the inflow side forms the first gap with the inner frame after expansion, and the inflow side is located at the avoidance port.

[0084] Optionally, the arm is at least partially located within the loading section.

[0085] Optionally, the loading structure includes a catheter sheath, and the arm portion is at least partially located outside the loading section and inside the catheter sheath.

[0086] The present application also provides a catheter sheath based on long-distance intervention, having opposite distal and proximal ends, the catheter sheath comprising a tube body and a hemostatic valve, the tube body comprising:

[0087] The main body segment, the hemostatic valve is connected to the proximal end of the main body segment, and the wall of the main body segment is provided with a structural reinforcement layer at least near the distal end, the reinforcement layer being a metal tube with a hollow structure;

[0088] The deformation section is located at the distal end of the main section. The deformation section includes a plurality of elastic sheets arranged at intervals along the circumference of the tube body. The proximal end of each elastic sheet is connected to the metal tube. Each elastic sheet has a relative initial state and an expanded state. In the expanded state, the distal ends of each elastic sheet are relatively far apart and the deformation section as a whole has a flared structure.

[0089] Optionally, the length of the tube is at least 60 cm.

[0090] Optionally, the length of the tube body ranges from 60 to 90 cm.

[0091] Optionally, the distal end of the tube has a pre-molded shape that matches the shape of the aortic arch.

[0092] Optionally, the metal tube is made of memory alloy.

[0093] Optionally, two adjacent elastic sheets are connected via a connecting piece.

[0094] Optionally, both ends of the connecting member are respectively connected to the elastic sheet on the corresponding side, and the connecting portion is adjacent to the distal end of the elastic sheet;

[0095] In the initial state of each elastic sheet, the middle portion of the connector is folded and stored in the spacing area between adjacent elastic sheets;

[0096] When the elastic sheets are in the expanded state, the middle parts of the connecting pieces are relatively spread out.

[0097] Optionally, two connecting members are connected between two adjacent elastic sheets, including a first connecting member and a second connecting member arranged along the axial direction.

[0098] Optionally, the first connecting member is connected to the distal end of the elastic sheet in the axial direction, and the second connecting member is connected to the middle part of the elastic sheet in the axial direction.

[0099] Optionally, the first connecting member and the second connecting member are V-shaped structures and respectively have a first opening and a second opening, and the first opening and the second opening are away from each other.

[0100] Optionally, both sides of the middle portion of the first connecting member have protrusions extending toward the proximal end, and the apex of the second connecting member is located within the two protrusions.

[0101] Optionally, the deformation section has a grid structure as a whole.

[0102] Optionally, the tube body has a three-layer structure, including an outer membrane layer, the reinforcement layer and an inner membrane layer from the outside to the inside.

[0103] Optionally, the elastic sheet and the metal tube are an integral structure or a separate structure.

[0104] Optionally, the hemostatic valve includes a housing and a sealing member disposed in the housing for preventing fluid leakage.

[0105] The present application also provides a control handle, the control handle having a distal end and a proximal end relative to each other, and an axial direction extending between the proximal end and the distal end. The distal end of the control handle is provided with an axially retractable ejection mechanism, the ejection mechanism comprising:

[0106] A telescopic assembly, with an abutment member at its distal end and an axially movable proximal end connected to a control handle;

[0107] The push-up drive mechanism is installed on the control handle and is linked with the proximal end of the telescopic assembly.

[0108] Optionally, the telescopic assembly is arranged in one or more stages from the distal end to the proximal end, wherein the distal end of the first stage is provided with the abutment member, and the proximal end of the last stage is axially movably connected to the control handle and linked to the ejection drive mechanism.

[0109] Optionally, each stage of the telescopic assembly is a cylindrical structure and is movably connected in sequence.

[0110] Optionally, one of the adjacent stages is an outer cylinder and the other is an inner cylinder, and when the telescopic assembly is extended, the inner cylinder moves toward the distal end relative to the outer cylinder.

[0111] Optionally, mutually cooperating anti-retraction structures are provided between adjacent stages.

[0112] Optionally, the anti-retreat structure includes:

[0113] a rack arranged outside the inner cylinder along the telescopic direction;

[0114] An operating button is swingably mounted on the outer cylinder, with an operating portion and a clamping portion on either side of the operating button's swing axis. The clamping portion engages with the rack to restrict movement between adjacent stages, and the operating portion is exposed to the outer cylinder for releasing the engagement between the clamping portion and the rack.

[0115] The elastic member acts on the operating button to drive the engaging portion to maintain engagement with the rack.

[0116] Optionally, the tooth tips of the rack are inclined toward the proximal side, and the tooth surface toward the proximal side drives the engaging portion to self-lock.

[0117] Optionally, the elastic member abuts between the inner wall of the outer tube and the radial outer side of the clamping portion.

[0118] Optionally, the engaging portion has a self-locking surface that cooperates with the rack, and the self-locking surface faces the distal end and is substantially perpendicular to the axial direction of the outer cylinder.

[0119] Optionally, the ejection drive mechanism includes:

[0120] an external thread section, located on the outer periphery of the final stage;

[0121] The first driving sleeve is rotatably mounted on the control handle and has an internal thread section that matches the external thread section.

[0122] The present application also provides a control handle for an artificial implant, comprising:

[0123] A support body comprising two rigid bars arranged side by side, wherein a guide channel is defined between the two rigid bars;

[0124] The driving mechanism is configured with multiple sets, wherein at least two sets of the driving mechanism respectively include a transmission member slidably mounted on the guide channel, and a driving sleeve rotatably sleeved on the outer periphery of the support body and threadedly matched with the transmission member.

[0125] Optionally, the length of the two rigid bars accounts for at least 75% of the total length of the control handle.

[0126] The present application also provides a control handle for controlling a catheter assembly, wherein the catheter assembly includes a first group and a second group movably sleeved from the outside to the inside, and the control handle includes:

[0127] a first handle, the first handle being used to connect the first group;

[0128] a second handle, the second handle being used to connect the second group;

[0129] The first handle and the second handle each include a support body, and each support body includes two rigid bars arranged side by side.

[0130] Optionally, the rigid strip is a metal strip.

[0131] Optionally, a plurality of weight-reducing holes are provided on the rigid bar.

[0132] Optionally, the rigid bar has a block that engages with the first handle and / or the second handle.

[0133] Optionally, the control handle includes a mounting seat fixedly connected to the rigid bar, and the drive sleeve is sleeved on the support body and rotatably engaged with the mounting seat.

[0134] Optionally, the driving sleeve includes an operating portion and a docking portion embedded in the mounting seat along its own axial direction, and the mounting seat separates the operating portions of two adjacent driving sleeves from each other.

[0135] The present application also provides a control handle for controlling a catheter assembly, wherein the catheter assembly includes a first group and a second group movably sleeved from the outside to the inside, and is characterized in that the control handle includes:

[0136] a first handle, the first handle being used to connect the first group;

[0137] a second handle, the second handle being used to connect the second group;

[0138] Among them, the first handle is equipped with a sliding seat and a driving sleeve located on the outer periphery of the sliding seat and threadedly transmitted with the sliding seat; the distal end of the second handle is provided with a connecting sleeve, the connecting sleeve and the sliding seat are rotationally matched, and a mutually cooperating rotation locking mechanism is provided between the two.

[0139] Optionally, the rotation locking mechanism includes:

[0140] Engaging teeth, located on the end surface of the proximal end side of the sliding seat and distributed around the rotation axis of the connecting sleeve;

[0141] an unlocking member, movably mounted on the connecting sleeve, having a locking position in cooperation with the meshing teeth, and an unlocking position in which the unlocking member is radially separated from the meshing teeth;

[0142] The driving member acts on the unlocking member to drive the unlocking member to remain in the locking position.

[0143] Optionally, the proximal end portion of the unlocking member is swingably mounted on the connecting sleeve, the connecting sleeve is provided with an operating window, and at least a portion of the unlocking member is exposed to the operating window.

[0144] Optionally, the unlocking members are arranged in pairs along the radial direction of the connecting sleeve, and the driving member is elastically compressed between the same pair of unlocking members.

[0145] Optionally, a radially extending guide groove is provided on an inner wall of the connecting sleeve, and at least a portion of the unlocking member moves along the guide groove.

[0146] Optionally, a guide step is provided in the connecting sleeve, and the unlocking member cooperates with the guide step and is radially guided inward by the guide step to have a tendency to move toward the unlocking position.

[0147] Optionally, the tooth shape of the meshing teeth is triangular.

[0148] Optionally, the unlocking member includes:

[0149] a pressing portion exposed to the operation window;

[0150] a swing shaft located at the proximal end side of the pressing portion;

[0151] a guide portion, located at a distal end of the pressing portion and cooperating with the guide groove;

[0152] The locking portion is located at the distal end of the guide portion and meshes with the meshing teeth. The locking portion is tapered as a whole and converges toward the distal end.

[0153] Optionally, at least a portion of the unlocking member is exposed to the connecting sleeve, and the exposed portion is exposed to the first handle or is received inside the first handle as the second handle moves axially.

[0154] The present application also provides a control handle for controlling a catheter assembly to operate an artificial implant, wherein the catheter assembly includes multiple shafts that are slidably nested inside and outside, the control handle includes a support body, a transmission member fixed to each shaft, and a drive sleeve that is threadedly driven by the transmission member, the sliding seat slides with the support body, and the drive sleeve rotates with the support body. Among the multiple shafts, the first shaft is in the innermost layer, and the proximal end of the first shaft is connected to a fourth transmission member and a force-applying member that slides relative to the support body. The first shaft slides axially so that the force-applying member has a first position that is at least partially hidden in the support body, and a second position that is exposed outside the support body, and the force-applying member can drive the first shaft to rotate.

[0155] Optionally, the force-applying component is a cylindrical structure.

[0156] Optionally, the force-applying component includes an operating segment and a connecting segment disposed at a distal end of the operating segment, and the connecting segment is connected to the transmission member.

[0157] Optionally, the connecting section has a first section extending into the transmission member and fixedly connected thereto, and an expanded diameter section connected to the proximal end of the first section, and the distal end of the operating section is provided with a snap-fit ​​portion that accommodates the expanded diameter section handle and circumferentially cooperates therewith.

[0158] Optionally, the cross-sectional shape of the expanded diameter section is non-circular.

[0159] Optionally, the side wall of the engaging portion is provided with an elastic buckle which abuts against the diameter-expanding section to limit the connection section from being separated from the operating section.

[0160] Optionally, the control handle includes a base provided at the proximal end of the support body, and the force-applying component is in radial clearance fit with the base.

[0161] Optionally, the first shaft is fixedly connected to the connecting section.

[0162] Optionally, the connecting section is threadably engaged with the fourth transmission member, and the operating section slides axially relative to the connecting section.

[0163] Optionally, the operating section rotates axially to drive the connecting section to move distally, and the operating section abuts against the proximal end of the fourth transmission member and limits the rotation of the operating section.

[0164] The present application further provides a transmission member for connecting an interventional catheter in a control handle, comprising a body having an axially extending through hole for inserting the interventional catheter, the body comprising:

[0165] a first half body, wherein the outer wall of the first half body is provided with threaded transmission teeth;

[0166] a second half body, engaging with the first half body, wherein the through hole is located between the first half body and the second half body;

[0167] The fixing member is surrounded by the first half body and the second half body, and has an interventional catheter fixing hole corresponding to the position of the through hole. The outer periphery of the fixing member and at least one of the first half body and the second half body are provided with mutually matching anti-rotation structures.

[0168] Optionally, the fixing member is a ring structure.

[0169] Optionally, the through hole has a first radial direction and a second radial direction that are relatively perpendicular to each other, and the body has threaded transmission teeth on both sides along the first radial direction;

[0170] The first half body and the second half body are engaged with each other along the second radial direction.

[0171] Optionally, the first half body and the second half body are fastened to each other via an elastic buckle.

[0172] Optionally, one of the first half body and the second half body is provided with a positioning slot extending along the second radial direction, and the other is provided with a positioning key matched with the positioning slot.

[0173] Optionally, the anti-rotation structure is configured as follows: the fixing member has a non-circular outer contour, and the first half body and the second half body both have anti-rotation inner edges that fit the outer contour of the fixing member.

[0174] Optionally, two opposite sides of the body along the second radial direction are smooth planes.

[0175] The present application provides an interventional delivery system for an artificial implant, characterized by comprising:

[0176] A catheter sheath is used for constructing an interventional channel, wherein the proximal end of the catheter sheath is provided with a fixing seat;

[0177] A bending adjustment component, the distal end of which can be controlled to change direction, and the bending adjustment component slides through the fixing seat and further extends toward the proximal end;

[0178] An inner shaft assembly, with a loading section at the distal end thereof for connecting an artificial implant, wherein the loading section is always exposed at the distal end of the bending adjustment assembly;

[0179] A control handle is connected to the bending adjustment assembly and the proximal end of the inner shaft assembly. The control handle is located on the proximal side of the fixing seat and the distance between the control handle and the fixing seat is adjustable.

[0180] Optionally, the catheter sheath has opposite distal and proximal ends, and the catheter sheath includes a tube body and a hemostatic valve, wherein the tube body includes:

[0181] The main body segment, the hemostatic valve is connected to the proximal end of the main body segment, and the wall of the main body segment is provided with a structural reinforcement layer at least near the distal end, the reinforcement layer being a metal tube with a hollow structure;

[0182] The deformation section is located at the distal end of the main section. The deformation section includes a plurality of elastic sheets arranged at intervals along the circumference of the tube body. The proximal end of each elastic sheet is connected to the metal tube. Each elastic sheet has a relative initial state and an expanded state. In the expanded state, the distal ends of each elastic sheet are relatively far apart and the deformation section as a whole has a flared structure.

[0183] Optionally, the length of the tube is at least 60 cm.

[0184] Optionally, the length of the tube body ranges from 60 to 90 cm.

[0185] Optionally, the distal end of the tube has a pre-molded shape that matches the shape of the aortic arch.

[0186] Optionally, the fixing seat has a mounting channel communicating with the catheter sheath, and a pipe joint connected to the mounting channel is provided at the proximal end of the fixing seat, and the pipe joint has:

[0187] A main interface, wherein a seal is provided at the main interface;

[0188] A branch interface is provided with a one-way valve.

[0189] Optionally, the fixed seat is a hemostatic valve.

[0190] Optionally, a bending drive mechanism is installed on the control handle, and the bending drive assembly includes:

[0191] The sheath is bent, and the proximal end is fixed to the control handle;

[0192] The bending adjusting member has one end fixedly extending to the distal end of the bending adjusting sheath and acting on the sheath, and the other end being controlled by the bending adjusting driving mechanism.

[0193] Optionally, the inner shaft assembly includes a first shaft, a second shaft, and a third shaft that are sequentially slidably sleeved from the inside to the outside, wherein:

[0194] The distal end of the first shaft is linked with a locking element;

[0195] A pull wire is connected to the distal end of the second shaft;

[0196] A base is fixed to the distal end of the third shaft, the locking element is movably mounted on the base, and a locking hole is provided on the base to match the locking element;

[0197] The pull wire is wound from the second shaft through the artificial implant and then is bound to the base by the locking element. The second shaft and the first shaft are slidably matched relative to the third shaft.

[0198] The present application also provides a control method for detaching an artificial implant from an interventional delivery system, comprising:

[0199] Provided are an artificial implant and an interventional delivery system for delivering the artificial implant. The artificial implant includes an inner frame defining a blood flow channel. The inner frame has a plurality of arms on its periphery, each arm forming a first gap between the inner frame and the inner frame that can accommodate native tissue. The inner frame is connected to a leaflet that controls the blood flow channel. The distal end of the inner frame is maintained in a compressed state by a tubular loading section, and the proximal end of the inner frame is maintained in a compressed state by being restrained by a pull wire.

[0200] First, expanding at least a portion of the arm to align the first gap with the native tissue;

[0201] driving the loading section distally to separate from the inner frame, so that the distal end of the inner frame expands;

[0202] The portion of the pull wire exposed from the locking element is stretched, causing the proximal end portion of the inner frame to expand, thereby deforming the inner frame as a whole to a desired extent, and the pull wire always maintains control over the inner frame during this process;

[0203] moving the loading section proximally so that at least a portion of the loading section enters the blood flow channel;

[0204] Release the connection between the pull wire and the inner frame.

[0205] The present application also provides a control method for recovering an artificial implant using an interventional delivery system, comprising:

[0206] Provided are an artificial implant and an interventional delivery system for delivering the artificial implant, the interventional delivery system comprising:

[0207] A catheter sheath, used for constructing an interventional channel, wherein the proximal end of the catheter sheath is provided with a fixing seat;

[0208] an inner shaft assembly having a loading section at its distal end, wherein the artificial implant is at least partially located in the loading section before expansion and is releasably connected to the inner shaft assembly;

[0209] A control handle connected to the proximal end of the inner shaft assembly, the control handle being located on the proximal side of the fixing seat, and a push mechanism that can interact with the fixing seat being provided at the distal end of the control handle;

[0210] The artificial implant at least partially remains connected to the inner shaft assembly. When being 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.

[0211] Optionally, the distal end of the catheter sheath approaches or contacts the artificial implant, driving the pushing mechanism to abut against the fixing seat and further push toward the distal end until the artificial implant is received in the catheter sheath.

[0212] Optionally, the artificial implant is connected to the inner shaft assembly via a pull wire, and when being recovered, the pull wire is kept in a tightened state to gather the proximal side of the artificial implant.

[0213] Optionally, before retrieval, the shape of the artificial implant is in an expanded state and is connected to the inner shaft assembly only by a pull wire. Before retrieval, the pull wire is tightened to gather the proximal side of the artificial implant.

[0214] Optionally, the artificial implant includes an inner frame defining a blood flow channel, the inner frame having a plurality of arms on its periphery, the proximal ends of the arms being fixed to the inner frame, a first gap for accommodating native tissue being formed between the distal ends of the arms and the inner frame, and a leaflet for controlling the blood flow channel being connected to the inner frame;

[0215] During the retrieval, the proximal end of the arm first enters the catheter sheath, and the distal end of the arm adaptively enters the catheter sheath as the catheter sheath moves relative to the artificial implant.

[0216] The present application also provides a method for loading an artificial implant into a delivery system, comprising:

[0217] An artificial implant and a delivery system are provided, wherein the artificial implant comprises an inner frame with a plurality of arms on the outer periphery of the inner frame;

[0218] The delivery system comprises:

[0219] a guide sheath with a fixing seat at the proximal end;

[0220] an inner shaft assembly movably arranged in the catheter sheath, wherein the distal end of the inner shaft assembly is provided with a loading section;

[0221] A control handle is connected to the proximal end of the inner shaft assembly.

[0222] Optionally, a pull wire is passed through the proximal end of the inner frame.

[0223] Optionally, the conveying system further comprises a control mechanism, wherein the control mechanism comprises a base connected to the inner shaft assembly, a locking member movably engaged with the base, and a plurality of the pull wires;

[0224] One end of the pull wire is connected to the control handle, and the other end is passed through the inner frame and locked to the base and the locking member, and multiple pull wires are locked one by one.

[0225] Optionally, during the locking process, the locking element moves relative to the base in a rotational manner.

[0226] Optionally, the pull wire is tightened to radially compress the proximal end of the inner frame.

[0227] Optionally, multiple pull lines are tightened synchronously.

[0228] Optionally, the distal end of the inner frame is stored in the loading section.

[0229] Optionally, the catheter sheath moves distally to accommodate the arm portion and the proximal end of the inner frame.

[0230] Optionally, the distal end of the inner frame and at least the distal end portion of the arm are stored in the loading section.

[0231] Optionally, the catheter sheath moves distally to accommodate the proximal end of the inner frame and the exposed portion of the arm.

[0232] Optionally, when the catheter sheath moves distally, it pushes the fixing seat distally relative to the control handle. Beneficial effects

[0233] The control mechanisms of the present application can cooperate with each other to realize the control of the expansion, release or recovery process of the artificial implant in the body. The structure has been further optimized and improved to make the control of the pull wire smoother. BRIEF DESCRIPTION OF THE DRAWINGS

[0234] FIG1a is a schematic diagram of a control mechanism restricting an artificial implant according to an embodiment of the present application;

[0235] FIG1b is a schematic structural diagram of a pull wire disengaging a lock member in the control mechanism of FIG1a;

[0236] FIG2a is a schematic diagram of a control mechanism restricting an artificial implant according to an embodiment of the present application;

[0237] FIG2b is a schematic structural diagram of a pull wire disengaging a locking element in the control mechanism of FIG2a;

[0238] FIG3 is a schematic diagram of a control structure with three pull wires in one embodiment of the present application;

[0239] FIG4 is a schematic diagram of the connection between each pull wire and the second shaft in the control structure of one embodiment of the present application;

[0240] FIG5 is a schematic structural diagram of an artificial implant according to an embodiment of the present application;

[0241] 6a to 6c are schematic diagrams showing the gradual retraction of the wire-controlled end of the artificial implant of the present application;

[0242] FIG7a and FIG7b are schematic diagrams of the artificial implant of the present application during threading and folding, respectively;

[0243] FIG8 is a schematic diagram of the structure of a pull wire restricting an artificial implant in a conventional control mechanism;

[0244] FIG9 is a schematic structural diagram of the pull wire in FIG8 being detached from the base to release the artificial implant;

[0245] FIG10 is a schematic structural diagram of a conveying system according to an embodiment of the present application;

[0246] Figure 11 is an enlarged view of part A in Figure 10;

[0247] FIG12 is a schematic diagram of the cooperation between the base, the locking element and the pull wire according to an embodiment of the present application;

[0248] FIG13a is an exploded view of the lock member, base and pull wire in FIG12;

[0249] FIG13b is a partial structural view of the distal end side of the second shaft in FIG13a;

[0250] FIG14 is a left side view of the conveying system in FIG10;

[0251] FIG15 is a partial cross-sectional view of the base in the BB direction in FIG14;

[0252] FIG16a is a schematic structural diagram of a pull wire at a free end according to an embodiment of the present application;

[0253] FIG16 b is a schematic structural diagram of a pull wire at a free end according to another embodiment of the present application;

[0254] FIG17 is a schematic structural diagram of a base according to an embodiment of the present application;

[0255] Figures 18a to 19 are schematic diagrams of the lock element sequentially passing through each pull wire in the control mechanism of the present application;

[0256] FIG20 a is a schematic structural diagram of a pull wire in a first state according to an embodiment of the present application;

[0257] FIG20 b is a schematic structural diagram of a pull wire in a second state according to an embodiment of the present application;

[0258] 21a to 21c are schematic structural diagrams respectively illustrating how a pull wire is sequentially coupled to each locking element according to an embodiment;

[0259] FIG22 is a front view of a base according to an embodiment of the present application;

[0260] FIG23a is a structural view of a positioning portion of a lock element according to an embodiment of the present application;

[0261] FIG23 b is a structural view of a positioning portion of a lock element according to another embodiment of the present application;

[0262] FIG24a is a diagram illustrating the matching structure of a lock element and a base according to an embodiment of the present application;

[0263] FIG24b is a structural view of the locking element in FIG24a;

[0264] FIG24c is a structural view of FIG24a after the locking elements are relatively separated;

[0265] FIG25 a is a structural view of the lock element and the base in cooperation with each other according to another embodiment of the present application;

[0266] FIG25b is an exploded view of FIG25a;

[0267] FIG26 is a schematic diagram of threading an artificial implant in the prior art;

[0268] FIG27 a is a diagram showing the folding route of an artificial implant in the prior art;

[0269] FIG27b is a schematic diagram of the artificial implant in FIG11b after being collapsed;

[0270] FIG28 is a diagram showing the folding route of the artificial implant of the present application;

[0271] FIG29 is a front view of a control mechanism according to an embodiment of the present application, wherein a pull wire pulls the proximal end of an artificial implant radially inwardly;

[0272] FIG30 a is a structural view of the control mechanism in one embodiment of the present application after the loading section is retracted and engaged with the locking element;

[0273] FIG30 b is a front view of the control mechanism in FIG30 a (with the pull wire removed for easier viewing);

[0274] FIG31 is a half-sectional view of the loading section and the locking element of the control mechanism in one embodiment of the present application after engagement;

[0275] FIG32 is a structural view of a loading section in a control mechanism according to an embodiment of the present application;

[0276] FIG33 is an exploded view of the loading section in FIG32;

[0277] FIG34a is an exploded view of the support member in FIG33;

[0278] Figure 34b is a half-section view of the support member;

[0279] FIG35 is a cross-sectional view of a loading section away from a base in a control mechanism according to an embodiment of the present application;

[0280] FIG36a is a partial structural diagram of a loading section of a control mechanism in an embodiment of the present application when loading an artificial implant;

[0281] FIG36 b 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;

[0282] FIG36c is a schematic diagram of the radial relationship between the loading section, the artificial implant, and the catheter sheath in the control mechanism according to an embodiment of the present application;

[0283] FIG37 is a structural view of an artificial implant according to an embodiment of the present application;

[0284] FIG38 is a front view of an artificial implant according to an embodiment of the present application;

[0285] FIG39 is a structural view of a delivery system according to an embodiment of the present application;

[0286] FIG40 is a structural view of a catheter sheath according to an embodiment of the present application;

[0287] FIG41 is an exploded view of the tube connector and the hemostatic valve in the catheter sheath of FIG40;

[0288] FIG42 is a structural view of the distal end of the catheter body in a retracted state in an embodiment of the present application;

[0289] FIG43 is a structural view of the distal end of the tube body in FIG42 in an expanded state;

[0290] FIG44 is an exploded view of a tube connector in a catheter sheath according to an embodiment of the present application;

[0291] FIG45 is a schematic structural diagram of the distal end of the catheter sheath in contact with the artificial implant according to one embodiment of the present application;

[0292] FIG46 is a schematic diagram of the structure of the recovered artificial implant in FIG45;

[0293] FIG47 is a schematic structural diagram of a control handle with respect to a bending adjustment mechanism according to an embodiment of the present application;

[0294] FIG48 is a partial cross-sectional view of a control handle at a ratchet wheel according to an embodiment of the present application;

[0295] FIG49 is a partial cross-sectional view of FIG48 showing the release of the ratchet restriction;

[0296] FIG50 is a schematic structural diagram of a position limiting member in a control handle according to an embodiment of the present application;

[0297] FIG51 is an exploded view of the control handle at the bending mechanism according to one embodiment of the present application;

[0298] FIG52a is a schematic structural diagram of a control mechanism wrapping and restraining an artificial implant according to an embodiment of the present application;

[0299] FIG52b is a schematic diagram of the structure of the control mechanism in one embodiment of the present application, which drives the catheter sheath to release the restraint on the arm;

[0300] 52c to 52e are schematic diagrams of releasing the pull wire in the control mechanism of the present application to gradually expand the proximal end of the artificial implant;

[0301] FIG52f is a schematic diagram of the structure of the control mechanism of the present application in which two mating parts cooperate with each other to release the pull wire;

[0302] Figure 52g is a schematic diagram of the control mechanism of the present application exiting the body;

[0303] FIG53 is a schematic structural diagram of a control handle according to an embodiment of the present application;

[0304] FIG54 is an exploded view of the ejection mechanism in FIG53;

[0305] FIG55 is a schematic diagram of the structure of the telescopic assembly in FIG53 with the first stage extended and abutting against the fixed seat;

[0306] FIG56 is a schematic diagram of the structure of the push drive mechanism in FIG55 driving the telescopic assembly to move toward the distal end;

[0307] FIG57 is a schematic structural diagram of the middle stage of the telescopic assembly of FIG55;

[0308] FIG58 is a schematic structural diagram of the first stage of the telescopic assembly of FIG55;

[0309] FIG59 is a half-sectional view of the final stage of FIG54;

[0310] FIG60 is a partial half-sectional view of a telescopic assembly in a control handle according to an embodiment of the present application;

[0311] FIG61 is a half-sectional view of FIG60 showing the operation portion being pressed down to release the restriction on the rack;

[0312] FIG62 is a structural view of a control handle according to an embodiment of the present application;

[0313] FIG63 is an exploded view of FIG62;

[0314] FIG64 is a schematic structural diagram of the support body in FIG63;

[0315] FIG65 is a schematic diagram of the structure of the connection between the support body and the mounting base;

[0316] FIG66 is a schematic diagram of the connection between the first handle, the second handle and the support body in FIG62;

[0317] FIG67 is a partial cross-sectional view of the second handle in FIG62;

[0318] FIG68 is an exploded view of a control handle according to another embodiment of the present application;

[0319] FIG69 is an exploded view of the first handle, the second handle, the first support body, and the second support body of the control handle of FIG68;

[0320] FIG70 is a partial cross-sectional view of the control handle of FIG68 at the connection between the first handle and the second handle;

[0321] FIG71 is an exploded view of the first handle and the support body in FIG68;

[0322] FIG72 is a schematic diagram of the connection between the first support body and the sliding seat in FIG71;

[0323] FIG73 is a structural view of one petal of the sliding seat in FIG72;

[0324] FIG74 is an exploded view of a control handle according to another embodiment of the present application;

[0325] FIG75 a is an exploded view of the area between the distal end portion of the second handle and the second support body in FIG74 ;

[0326] FIG75 b is a schematic structural diagram of the unlocking member in FIG75 a ;

[0327] FIG76 is a half-sectional view of FIG74 showing the unlocking member and the sliding seat engaged to restrict the second handle from rotating relative to the first handle;

[0328] FIG77 is a half-sectional view of FIG76 showing the unlocking member released from engagement with the sliding seat;

[0329] FIG78 is a structural view of the component with the operating window in FIG75a;

[0330] FIG79 is a structural view of the component with the operating window in FIG78 from another perspective;

[0331] Figure 80 is a cross-sectional view of Figure 77;

[0332] FIG81 is a cross-sectional view of the end of the control handle at the force-applying component according to one embodiment of the present application;

[0333] FIG82 is a cross-sectional view of FIG81 showing the force-applying member extending the second handle toward the proximal end;

[0334] FIG83 is an exploded view of a fourth transmission member and a force-applying member according to an embodiment of the present application;

[0335] FIG84 is a half-sectional view of the operating section in FIG83;

[0336] FIG85 is an exploded view of a transmission member according to an embodiment of the present application;

[0337] FIG86 is a structural view of a transmission member according to an embodiment of the present application;

[0338] FIG87 is an exploded view of a transmission member according to another embodiment of the present application;

[0339] FIG88 is an exploded view of the transmission member of FIG87 from another perspective;

[0340] FIG89 is a schematic structural diagram of a catheter sheath according to an embodiment of the present application;

[0341] FIG90 is a schematic structural diagram of a catheter sheath interventional delivery to the aortic arch according to an embodiment of the present application;

[0342] FIG91 is a schematic diagram of the structure of the catheter sheath assisting in the recovery of the artificial implant in FIG2a;

[0343] FIG92 is a schematic structural diagram of the distal end of the catheter sheath during bending adjustment according to an embodiment of the present application;

[0344] FIG93 is a schematic structural diagram of a deformation section in an initial state according to an embodiment of the present application;

[0345] FIG94 is a partial enlarged schematic diagram of FIG93;

[0346] FIG95 is a schematic structural diagram of the deformation section in FIG93 in an expanded state;

[0347] FIG96 is a partial enlarged schematic diagram of FIG95;

[0348] FIG97 is a partially enlarged schematic diagram of a deformation segment in an initial state according to another embodiment of the present application;

[0349] FIG98 is a partially enlarged schematic diagram of the deformation section in FIG97 in an expanded state;

[0350] FIG99 is a cross-sectional view of a tube body at a metal tube according to an embodiment of the present application;

[0351] FIG100 is a schematic structural diagram of a deformation segment in an expanded state according to another embodiment of the present application;

[0352] FIG101 is a schematic structural diagram of a deformation section in an initial state according to another embodiment of the present application;

[0353] Figure 102 is a partial front view of the deformation section of Figure 101 in the initial state.

[0354] The reference numerals in the figures are described as follows:

[0355] 10. Base; 101. Locking area; 101a. Locking area; 102. Rib; 102a. Rib; 102b. Rib; 1021. Bend section; 1022. Avoidance area; 103. First cavity; 104. First opening; 105. Locking hole; 105a. Locking hole; 105b. Locking hole; 105c. Locking hole; 105d. Locking hole; 105e, lock hole; 105f, lock hole; 106, extension section; 107, ring structure; 108, second opening; 11, pull wire; 11a, pull wire; 11b, pull wire; 11c, pull wire; 111, free end; 111a, free end; 111b, free end; 111c, free end; 112, forward section; 113, control end; 114, return section; 115, ring; 116, intermediate section; 13, lock element; 131, positioning section; 1311, terminal end; 1313, head end; 135, connecting section; 1351, connecting section; 1352, linkage key; 1353, closing structure;

[0356] 21. First axis; 23. Second axis; 25. Third axis; 27. Extension tube; 28. Bending member; 211. Loading section; 212. Support member; 213. Outer cylinder; 2131. Positioning piece; 214. Inner cylinder; 2141. Linkage groove; 2142. Expanding structure; 215. Guide head; 216. Loading section; 217. Avoidance opening; 231. Connecting hole; 232. Notch; 233. Connecting arm; 234. Deformation hole;

[0357] 3. Control handle; 31. Proximal end; 32. Distal end; 310. First handle; 320. Second handle;

[0358] 330, support body; 331, first support body; 332, second support body; 333, rigid bar; 334, guide channel; 335, block; 336, weight-reducing hole; 337, slot; 340, transmission member; 3401, body; 3402, first half; 3403, second half; 3404, through hole; 3405, fixing member; 3406, threaded transmission tooth; 3407, elastic buckle; 3408, groove; 3409, slot; 3410, positioning key; 341, first transmission member; 342, second transmission member; 3 43. Third transmission member; 344. Fourth transmission member; 345. Sliding seat; 3451. Engaging teeth; 3452. Collar; 346. Unlocking member; 3462. Guide groove; 3463. Pressing portion; 3464. Swing shaft; 3465. Guide portion; 3466. Locking portion; 347. Driving member; 348. Operating window; 3491. Fixing hole; 350. Driving sleeve; 351. First driving sleeve; 352. Second driving sleeve; 353. Third driving sleeve; 354. Fourth driving sleeve; 355. Force-applying member; 3551. Operating section ; 3552, connecting section; 3553, first section; 3554, diameter expansion section; 3555, snap-fitting portion; 3556, elastic buckle; 356, drive ring; 3561, operating portion; 3562, docking portion; 357, first locking ring; 358, second locking ring; 360, mounting seat; 361, first mounting seat; 362, second mounting seat; 363, third mounting seat; 364, connecting sleeve; 3641, base; 3642, guide step; 37, bending drive mechanism; 371, winding wheel; 3711, ratchet; 372, knob ; 374, limit member; 3741, ratchet; 375, elastic member; 376, dial button; 38, telescopic assembly; 381, first stage; 382, ​​intermediate stage; 383, final stage; 3831, external thread segment; 384, abutment member; 3851, blocking portion; 3852, guide groove; 3861, diameter expansion portion; 3862, rack; 3863, elastic buckle; 3864, guide strip; 387, operating button; 3871, operating portion; 3872, engaging portion; 3873, self-locking surface; 388, elastic member; 39, ejection drive mechanism;

[0359] 4. Catheter assembly; 43. Bend sheath;

[0360] 501, spacer opening; 502, hollow area; 504, middle part; 505, distal side edge; 506, protrusion; 51, tube body; 55, hemostatic valve; 510, main section; 511, metal tube; 513, outer membrane layer; 514, inner membrane layer; 520, deformation section; 521, elastic sheet; 522, connector; 523, first section; 524, second section; 525, second connector; 526, first connecting section Connector; 527, first opening; 528, second opening; 529, apex; 551, first connecting channel; 552, second connecting channel; 56, bending adjuster; 581, connecting portion; 582, first opening; 583, third section; 584, fourth section; 585, second gap; 586, third gap; 587, second opening; 588, connector; 591, first deformation strip; 592, second deformation strip;

[0361] 60. Artificial implant; 601. Wire control terminal; 603. Eyelet; 605. Connecting ear; 61. Internal frame; 63. Arm; 631. Inflow side; 632. Outflow side; 604. Blood flow channel;

[0362] 70. Catheter sheath; 720. Fixing seat; 721. Mounting channel; 750. Pipe joint; 751. Main interface; 752. Seal; 753. Branch interface; 754. One-way valve. Modes for Carrying Out the Invention

[0363] 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.

[0364] 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.

[0365] 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.

[0366] 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.

[0367] This specification describes an artificial implant and a delivery system for delivering the artificial implant into a subject's body. 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 about 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.

[0368] 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.

[0369] 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.

[0370] Depending on the expansion 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 can expand using balloons, 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.

[0371] Taking a self-expanding stent as an example, its expansion and retraction can be controlled by a sheath wrapped around the periphery of the stent. The stent is controlled accordingly by varying the location of the stent exposed to the sheath. It can also be controlled by a pull wire, where the pull wire passes through the structural gap (or wire hole structure) of the stent. The degree of stent expansion 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 completely released. Of course, the control of the pull wire is also accomplished through the various controlled components in the catheter assembly.

[0372] 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 released from the constraints of the catheter assembly and radially expanded in the body, it is in an expanded state. 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 taken into account.

[0373] 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.

[0374] 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.

[0375] The present application provides a control mechanism for an artificial implant, comprising a base 10, a pull wire 11, and a locking element 13. The base 10 has a locking hole, the pull wire 11 has a free end 111 that can be passed through or detached from the artificial implant 60, and the locking element 13 is located entirely at the distal end of the base 10. The locking element 13 rotatably cooperates 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 that are opposed, and an axial direction extending between the distal end 32 and the proximal end 31. The proximal end, distal end, and axial direction, unless otherwise specified, also apply to other components of the control mechanism, as well as the control handle and delivery system of the following embodiments.

[0376] The free end 111 is the end of the pull wire 11 that first passes through and last leaves 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, which can be directly fixed to the base 10, or extend proximally and controllably.

[0377] The free end 111 has a first state where it is restricted to the base 10 (as shown in Figure 1a) and a second state where it is released (as shown in Figure 1b). The locking element 13 flexibly engages with the base 10, and the locking element 13 cooperates with the free end 111 of the pull wire 11 to switch the state of the free end 111. In the first state, the free end 111 is combined with the locking element 13, and the locking element 13 cooperates with the base 10 to restrict the pull wire 11 from being separated from the locking element 13. At this time, the free end 111 can be understood as being relatively fixed to the locking element 13. In this state, the pull wire 11 is always connected to the artificial implant 60, 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.

[0378] 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 as being released, thereby releasing the mutual connection between the artificial implant and the control mechanism. Subsequently, the control mechanism as a whole can be withdrawn outside the body, leaving the artificial implant in a predetermined position in the body.

[0379] 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 be combined with the locking element 13 .

[0380] 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.

[0381] The locking element 13 is located at the distal end of the base 10, facilitating observation and manipulation during in vitro pre-assembly and easing assembly. In particular, the locking element 13 and the base 10 are not radially nested, creating ample radial space for the pull wire to pass through and ensuring smoother movement. Furthermore, the maximum radial dimensions of the base 10 and / or locking element 13 can be reduced accordingly, facilitating in vivo interventional delivery.

[0382] Of course, the control mechanism of the present application and other embodiments described below including the control mechanism of this embodiment are also applicable to simulation training of interventional delivery operations performed in vitro.

[0383] The control end 113 of the pull wire 11 can be extended and controlled by a control handle, and its movement can change the length of the pull wire exposed outside the base 10, specifically, it can be axial movement, rotation or winding.

[0384] The artificial implant 60 is cylindrical and has a corresponding circumferential orientation. Multiple pull wires 11 are provided, and the control ends 113 of each pull wire 11 can be controlled independently or moved synchronously. The locations where the pull wires 11 interact with the artificial implant 60 are spaced apart along the circumference of the artificial implant 60, thereby improving the synchronization of the contraction and expansion of the artificial implant 60. For example, in Figure 3, there are three pull wires 11, interacting with the artificial implant 60 at three locations and spaced apart around the circumference of the artificial implant.

[0385] 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 provided on the base.

[0386] 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 entangled with each other. For example, as shown in Figure 4, the control mechanism also 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.

[0387] As shown in FIG5 , the artificial implant 60 has an axial direction in space, 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 has an eyelet 603 for a pull wire (not shown in the figure for clarity) to pass through.

[0388] The eyelets are formed as follows:

[0389] The artificial implant includes a hollow portion forming an eyelet, and the hollow portion is a type of structural gap of the artificial implant;

[0390] Or directly punch holes to form holes (e.g. Figure 5);

[0391] Or it can be independently configured on an artificial implant (such as welding, etc.).

[0392] 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 .

[0393] In the first state, the free end 111 of the pull wire can prevent the artificial implant 60 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 60 can still have multiple states depending on the degree of its deformation, such as relative:

[0394] In the expanded state, the wire control end 601 radially expands away from the base 10 (as shown in FIG6 a ), and the round-trip paths of the same pull wire 11 passing through the artificial implant 60 do not overlap;

[0395] In the retracted state, the wired control end 601 is radially retracted and close to the base 10 (as shown in FIG6 c );

[0396] In the intermediate state, the wire control terminal 601 is between the expanded state and the retracted state (as shown in FIG6 b ).

[0397] As shown in Figures 5 to 7a, multiple eyelets 603 are arranged in a sequentially spaced arrangement along the circumference. In the expanded state, the same pull wire 11 passes through at least two eyelets 603, meaning that one pull wire 11 can act on two locations circumferentially of the wire-controlled end 601. In a preferred embodiment, the number of eyelets 603 is twice the number of pull wires 11, with the same pull wire 11 corresponding to two eyelets 603. This allows the circumferential contraction and expansion of the wire-controlled end 601 of the artificial implant 60 to be synchronized, 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.

[0398] At least two stay wires are configured for the entirety of the artificial implant 60. In addition, only one stay wire is allowed to be threaded through the same eyelet to avoid the interference caused by the reciprocating threading.

[0399] As can be seen in FIG7 a , in this state, the extension direction (radial direction) of the pull wire between the artificial implant 60 and the base 10 , i.e., the pulling force direction, is perpendicular to the unlocking movement direction (circumferential direction) of the locking element, making unlocking easier.

[0400] For example, as shown in Figures 7a and 7b, the round-trip path of the same pull wire 11 through the artificial implant roughly encloses a triangular area, meaning the round-trip paths do not overlap. Otherwise, if the round-trip paths overlap, the extension path of the pull wire 11 will be a single straight line or curve, and will not enclose a specific area. The specific relationship between the path of the pull wire 11, the base 10, and the locking element 13 will be described in the following embodiments.

[0401] As shown in Figures 10 to 15, the base 10 has a locking area 101, and the locking member 13 has a positioning portion 131 that enters or moves out of the locking area 101 during rotation. The positioning portion 131 cooperates with the free end 111 of the pull wire 11 to limit the artificial implant 60; the interior of the base 10 has a first cavity 103, the proximal side of the base 10 has a first opening 104 that communicates with the first cavity 103, and the outer peripheral surface of the base 10 has a second opening 108 that communicates with the first cavity 103; the pull wire 11 is passed through the first cavity 103, and one end thereof (i.e., the control end) extends out of the base 10 proximally through the first opening 104, and the other end of the pull wire 11, i.e., the free end 111, extends out of the base 10 through the second opening 108 to connect to the artificial implant 60.

[0402] The pull wire 11 passes through the first cavity 103 of the base 10 to reduce the radial space occupied, and the locking piece 13 is not in the first cavity 103, so the movement of the pull wire 11 will not be interfered by the locking piece 13, making the movement of the pull wire 11 smoother and facilitating the expansion control of the artificial implant.

[0403] The locking area 101 can be within the overall outer contour of the base 10 to accommodate the free end in the first state, and the locking area 101 can be open toward the distal end to optimize the extension path of the pull wire 11. For example, the locking area 101 is located at the second opening.

[0404] In conventional technology, for example, Figures 8a and 8b illustrate how locking element 13 slides axially, disengaging positioning portion 131 from locking region 101 and allowing pull wire 11 to detach from the artificial implant. In this embodiment, positioning portion 131, as a portion of locking element 13, displaces at least circumferentially during operation. This reduces or even eliminates axial travel variation of locking element 13, reduces the axial space occupied by related components and even the proximal control handle, and further facilitates the configuration of the transmission mechanism.

[0405] In the first state, the pull wire 11 is constrained by the artificial implant 60 and primarily moves in the radial direction. In the second state, the free end of the pull wire 11 is free. The second opening 108 encompasses the radial sidewalls and distal end surface of the base 10, facilitating movement of the pull wire 11 in all directions in the first state and rapid and smooth retraction in the second state.

[0406] Regarding the coordination between the free end 111 and the positioning portion 131, in one embodiment, the free end 111 has a loop 115. When the free end 111 is in a first state, the positioning portion 131 penetrates the loop 115. When the free end 111 is in a second state, the positioning portion 131 withdraws the loop 115. The loop 115 can be independently configured (as shown in FIG16a) or wound around the cable 11 itself (as shown in FIG16b). The cable 11 can be single-strand or multi-strand. For example, a single strand can extend to the control end 113, or two strands can extend in parallel to the control end 113, or two strands can extend in parallel for a period of time and then be combined to extend to the control end 113.

[0407] 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 member 13 moves.

[0408] In one embodiment, as shown in Figures 12 and 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 on the outer periphery of the second shaft 23. The third shaft 25 and the second shaft 23 are both pipes, 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. The connecting hole 231 corresponds to the pull wire one-to-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 circumference.

[0409] As shown in Figures 13a and 13b, in one embodiment, the distal wall of the second shaft 23 is provided with a plurality of notches 232 spaced apart from each other. Adjacent notches 232 form connecting arms 233, and connecting holes 231 are provided at the distal ends of the connecting arms 233. During distal or proximal movement of the second shaft 23, the connecting arms 233 deform in response to the movement of the pull wire, with this deformation including at least radial deformation. In one embodiment, a deformation hole 234 is provided on the proximal side of the connecting holes 231 in the connecting arms 233.

[0410] As shown in Figures 17-18b, in one embodiment, multiple dividers are arranged circumferentially on the base 10, with adjacent dividers separating a second opening 108. Therefore, multiple second openings 108 are spaced apart circumferentially along the base 10. The dividers are ribs 102, shown in the figures. The strip-like structure minimizes its own circumferential span to maximize the circumferential span of the second opening, facilitating the routing of cables. For example, a cable can extend through a locking zone and then return to the same locking zone; or a cable can extend through a locking zone and then return to an adjacent locking zone, ensuring that the two points of application are sufficiently close. The ribs 102 also serve as reinforcement ribs to maintain the basic strength requirements of the base.

[0411] In the first state, the free end 111 extends out of the base 10 through the corresponding second opening 108, passes around the artificial implant, and then returns to the locking area corresponding to the same second opening 108 (as shown in FIG18a ), or returns to a position circumferentially adjacent to the second opening 108 (as shown in FIG18b ).

[0412] As shown in Figure 19, the position circumferentially adjacent to the second opening 108 can be another adjacent locking area 101, or a channel separately configured for threading the pull wire. The formation of the channel can adopt the same structural principle as the locking area. For example, there are six second openings 108, three of which are spaced apart as channels for the free ends of the pull wires to extend out of the base 10, and the other three are spaced apart as locking areas 101. For example, in Figure 19, in terms of circumferential span, the span of the locking area 101 is α, and the span of the channel circumferentially adjacent to it is β, satisfying α / β=1.1~2.

[0413] As shown in Figure 17 , all ribs 102 converge and secure at the distal end of the base 10, forming an annular structure 107. All ribs 102 are continuously distributed circumferentially at the proximal end 31 of the base 10, forming 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 allows for the passage of other pipes, such as the first shaft described below.

[0414] As shown in FIG20a and FIG20b, in one embodiment, the base 10 is provided with a lock hole 105 for inserting the positioning portion 131. The positioning portion 131 has:

[0415] In the locked state, the positioning portion 131 is inserted into the lock hole 105 to prevent the free end 111 of the pull wire 11 from being disengaged (as shown in FIG. 20 a );

[0416] 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 (as shown in FIG. 20 b );

[0417] As shown in Figure 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. Locking holes 105a and 105b are opened on the opposite sides of the two ribs. Of course, the locking holes can also pass through the ribs. One section of the positioning part 131 is in the locking area 101a, and the two ends of the section are respectively inserted into the locking holes 105a and 105b.

[0418] Combined with the movement direction of the locking member 13 , the opening of the locking hole 105 faces the circumference of the base 10 .

[0419] When the positioning portion 131 moves along the first direction (such as X in Figure 20b), the free end 111 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.

[0420] In terms of quantity, there are multiple ribs 102 with locking holes 105. The positioning portion 131 as a whole has opposite ends 1311 and head ends 1313. The head ends 1313 are sequentially inserted (as shown in Figure 20a) or sequentially disengaged from each locking hole 105 (as shown in Figure 20b) as the locking member 13 rotates. Taking the sequential insertion of the positioning portion as an example, as shown in Figures 21a to 21c, the head ends 1313 are sequentially engaged with the locking hole 105a, free end 111a, locking hole 105b, locking hole 105c, free end 111b, locking hole 105d, locking hole 105e, free end 111c, and locking hole 105f. Sequential disengagement is the opposite of sequential engagement. The benefit of sequential insertion is reflected in the sequential engagement between the positioning portion and the pull wire during in vitro pre-assembly, which facilitates assembly.

[0421] In a preferred embodiment, all ribs 102 are provided with locking holes 105, through which the positioning portion 131 rotates and provides a certain degree of movement guidance. During the process of rotating the locking element into each locking hole, the head end 1313 eventually abuts against the side wall of one of the ribs 102 or is inserted into the corresponding locking hole, thus acting as a limit.

[0422] 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.

[0423] Referring to Figure 22 , in one embodiment, one axial section of the rib 102 is a radially inwardly extending bent section 1021, and the locking hole 105 is located in the corresponding bent section 1021 of the rib 102. All bent sections 1021 collectively form a clearance zone 1022 (the dashed area shown). When the proximal end of the artificial implant is retracted, it resides within the clearance zone 1022. This also facilitates the retraction of the loading section described below, allowing it to partially enter the clearance zone 1022 and align with the outer periphery of the base 10.

[0424] In combination with the rotation 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, maintain the necessary length of the lock, and achieve control of the free ends of all pull wires with the same lock. It also eliminates the axial dimension changes of the control mechanism and retains the original function of the lock to cooperate with the pull wires one by one, which facilitates the coordinated assembly of the lock, pull wire and base during the assembly stage.

[0425] Specifically, the opening of the lock hole faces the circumference of the base, and the positioning portion is rod-shaped. The rod can be a straight rod or a curved rod. There is only one rod and it cooperates with the free ends of all the pull wires. The positioning portion is inserted into or out of the lock hole as the lock rotates. For example, in Figures 23a and 23b, the positioning portion 131 is a spiral structure, and the spiral structure is coiled at least once. For example, the spiral structure is a multi-turn structure, and the turns are arranged axially (each turn is around the circumference of the base). The main line 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 partially a conical spiral.

[0426] As shown in Figures 24a to 24c, the lock 13 has a connecting portion 135 at the distal end of the base 10. The control mechanism further includes a first shaft 21 in transmission engagement 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.

[0427] Along the winding direction of the spiral structure, the positioning portion 131 has an opposite end 1311 and a head 1313. One end is fixed to the connecting portion 135, while the other end is relatively free. The positioning portion 131 and the connecting portion 135 can be connected separately, such as by welding or assembly, or integrally formed.

[0428] In this embodiment, the tip 1313 of the positioning portion 131 engages with the base 10 and the pull wire. The portion of the positioning portion 131 near the distal end 1311 is secured to the connecting portion 135, for example, at the periphery or distal end of the connecting portion 135. This connection can be achieved by direct welding of the ends or by welding after partial overlap. The connecting portion 135 is tubular, with other components, such as the first shaft 21, positioned within it. To enhance connection strength and prevent component extension, the positioning portion 131 can be spirally wound around the periphery of the connecting portion 135.

[0429] In one embodiment, a positioning mechanism is provided between the connecting portion 135 and the base 10 to maintain their axial position during pre-assembly. The connecting portion 135 can be a tubular structure extending in a constant diameter. The positioning mechanism includes a first end surface disposed at the proximal end of the connecting portion and a second end surface disposed at the distal end of the base, abutting against the first end surface. During pre-assembly, the first end surface abuts against the second end surface, and the positioning portion and the locking hole of the base engage in position.

[0430] The head end 1313 of the positioning portion 131 needs to adapt to the radial position of the keyhole, and the portion close to the end 1311 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 keyhole. Therefore, the spiral extension path of the positioning portion 131 is a conical spiral.

[0431] Alternatively, as shown in Figures 25a and 25b , the proximal end of the connecting portion 135 radially expands outward to form a connecting segment 1351. The distal end of the base 10 has an extension segment 106. The connecting segment 1351 and the extension segment 106 are nested together. In the figure, the connecting segment 1351 is a cylindrical structure and is sleeved on the outer circumference of the extension segment 106. The connecting segment 1351 compensates for the aforementioned deviation, so the spiral extension path of the positioning portion 131 is a cylindrical spiral. In this case, the bottom wall of the connecting segment 1351 is the first end surface.

[0432] The connecting portion 135 is movably mounted on the outer circumference of the distal end of the first shaft 21. The connecting portion 135 and the distal end of the first shaft 21 are axially separable. When the two are engaged, the connecting portion 135 and the first shaft can maintain synchronization in the circumferential direction, at least controlling the proximal end of the first shaft 21 to drive the locking element 13 to rotate. Axial separation means that the two can be separated from each other to release the engagement or engaged to maintain synchronization, with the specific switching of the engagement relationship between the two depending on the operational requirements.

[0433] As shown in Figure 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 with 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 below), and the return section is connected to the positioning portion and interacts with it to form a second action point (X2 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.

[0434] In another embodiment, as shown in Figure 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 point of action (hereinafter referred to as X1). The return section 114 is connected to the positioning portion 131 and interacts with it to form a second point of action (hereinafter referred to as X2). Combined with the above, the space in the locking area 101 is larger than the axial gap, facilitating the insertion of the cable. Furthermore, during pre-assembly, the cable can be first passed through the base, and then the locking element and base are rotated together and the free end is inserted simultaneously, facilitating assembly.

[0435] The wire 11b shows the state after threading is completed, and the bold parts are the forward section 112 and the return section 114 of the wire 11b.

[0436] As shown in FIG. 7 a , the pull wire 11 b 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 11 b and the artificial implant.

[0437] Here, in conjunction with prior art, we will explain: In Figure 26 , artificial implant 60 has three circumferentially spaced holes 603, corresponding to three pull wires. The specific threading paths refer to pull wire 11c, and their round-trip paths overlap. During the retraction process, the pull wires exert force only in the radial direction. The artificial implant generates corresponding stress in the circumferential direction, which reacts on the pull wires, gradually increasing the force required to apply the pull wires and affecting the feel of operation.

[0438] However, the pull wire of this embodiment is triangular in shape, which not only generates radial force, but also generates force on the line connecting the two connection points (Y1, Y2) (as shown by the solid arrow in Figure 7a) to directly overcome the stress changes during the deformation process of the artificial implant. The change in the overall force of the pull wire is smaller than that of the existing one, and the operation feel is more delicate.

[0439] In conventional technology, the spacing between adjacent eyelets 603 is relatively far (i.e., the circumferential span is large), and the eyelets 603 are provided on the connecting ears 605 (as shown in Figure 27a). Adjacent connecting ears 605 are independently connected to the pull wire. During the collapse process, adjacent connecting ears 605 may eventually misalign and overlap (as shown in the bold portion of Figure 27b), affecting subsequent expansion. However, the pull wire routing path of this embodiment allows the connecting ears 605 and the structural gap to be mostly or completely controlled by the pull wire, reducing or even eliminating the problem of misalignment and overlap during collapse (as shown in Figure 7b).

[0440] If the two points of action (X1, X2) are located in the same locking zone and are adjacent to each other, the pull wire's round-trip path will roughly form an equilateral triangle. This means that the two bolded forward segments 112 and return segments 114 in Figure 7a are equal in length, and the corresponding forward segments 112 and return segments 114 move at the same rate, improving the synchronization of the contraction or expansion of the artificial implant 60. If, as shown in Figure 28, the circumferential span of the two points of action (X1, X2) is large, the corresponding forward segments 112 and return segments 114 have different lengths and corresponding different rates of movement, resulting in abnormal contraction / expansion of the artificial implant.

[0441] To improve the synchronization of artificial implant contraction and expansion, existing technologies require a larger number of pull wires (e.g., six or more). However, this requires consideration of the spatial arrangement of the pull wires at the proximal end, as this can lead to the pull wires being too close together and causing friction or entanglement. The threading method of this embodiment, however, requires fewer pull wires, thereby meeting space requirements.

[0442] The control mechanism can be installed in a delivery system, which also includes a control handle at the proximal end of the delivery system and an inner shaft assembly connected between the control handle and the control mechanism, wherein the inner shaft assembly includes the first shaft, the second shaft and the third shaft.

[0443] 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.

[0444] Referring to Figures 11, 29, 30a, and 30b, the present application further provides a locking mechanism for connecting an artificial implant to a delivery system, comprising 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. The loading section 211 is open toward the proximal end and is configured to accommodate the distal end of the artificial implant 60. The pull wire 11 has a free end 111 that can be passed through or detached from the artificial implant 60. The third shaft 25 is slidably mounted on the exterior of the first shaft 21. A locking assembly is mounted on the third shaft 25. When loaded, the artificial implant 60 is restrained to the locking assembly by the pull wire 11. The locking assembly comprises a locking member 13 and a base 10. The locking member 13 and the base 10 have mutually engaged locking states (a first state corresponding to the pull wire) and released states (a second state corresponding to the pull wire), respectively restricting and allowing 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 aforementioned embodiment. For example, the locking mechanism can further include a second shaft 23, which is slidably disposed between the first shaft 21 and the third shaft 25, with 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.

[0445] The linkage assembly acts between the first shaft 21 and the locking element 13, enabling selective linkage between them. This can be understood as a state where the first shaft 21 and the locking element 13 cooperate with each other, with the first shaft 21 driving the movement of the locking element 13, and a state where the coupling is released, allowing the two to move independently. The linkage occurs after the artificial implant 60 is accurately positioned and expanded, and before the delivery system is ready for removal.

[0446] The two can be coupled / disconnected by movement of at least one relative to the other. For example, if the locking element 13 is located at the distal end of the base, the linkage assembly includes two mating portions, one connected to the loading section 211 and the other connected to the locking element 13. Axial movement of the loading section 211 can cause the two mating portions to engage or disengage. In one embodiment, after the artificial implant 60 is accurately positioned and expanded, the loading section 211 located at the distal end is first moved proximally and coupled to the locking element 13. At this point, the loading section 211 is inevitably located within the artificial implant 60 in terms of axial position. The first shaft 21 is then rotated, and control of the pull wire 11 is released via the linkage assembly. During the rotational operation, the proximal end of the loading section 211 is unlikely to interfere with, or even will not interfere with, the distal end of the artificial implant. For example, the loading section 211 is suspended from the distal end of the artificial implant. Furthermore, there is no need for a separate drive tube for the locking element, simplifying the structure.

[0447] The two matching parts are a linkage key and a linkage groove that can be axially slidably separated, and the linkage key is rotated and linked to each other when inserted into the linkage groove. Of course, the two matching parts can also be a linkage key and a linkage groove that can be relatively rotated and separated, and the linkage key is axially linked to each other when inserted into the linkage groove.

[0448] There are multiple linkage keys, the loading section and the locking piece are at least partially tubular, the multiple linkage keys are arranged along the circumference of the tubular portion, and correspondingly, there are multiple linkage grooves.

[0449] 31 to 34 b , 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 engaged through a linkage assembly to drive the lock 13 to rotate relative to the base 10 .

[0450] 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 the side walls of the linkage groove 2141 abut against the side walls of the linkage key 1352 in the circumferential direction (as shown in Figure 31). The connecting portion 135 is a cylindrical structure, and the linkage key 1352 is sheet-shaped. In one embodiment, the linkage keys 1352 are distributed at 2 to 4 locations along the circumference, for example, there are 2 linkage keys 1352.

[0451] Preferably, the notch of the linkage slot 2141 is provided with an expanding 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 1353 for guiding the insertion into the notch.

[0452] When engaged, the loading section 211 nests with the connecting portion 135. A linkage key 1352 is provided on the inner circumference of the loading section 211, positioning the loading section 211 within the artificial implant. A support member 212 is provided on the inner circumference of the loading section 211. The support member 212 is secured to the distal end of the first shaft 21 and includes a mating portion (i.e., the linkage key) disposed on the support member 212. A stopper structure is provided between the support member 212 and the loading section 211 to prevent axial separation between the two.

[0453] 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 periphery of the loading section 211 and cooperating with the positioning piece 2131 .

[0454] The support member 212 is a cylindrical structure with a partially outward-turned outer periphery forming a positioning tab 2131. The support member 212 comprises an outer cylinder 213 connected to the loading section 211 and an inner cylinder 214 with a linkage key fixed to the first shaft 21. The inner and outer cylinders can be integrally formed or constructed as separate parts, for example by bonding. The outer cylinder 213 has a partially warped outer periphery forming the positioning tab 2131, while the inner cylinder 214 has a partially recessed inner periphery forming the linkage groove 2141.

[0455] The loading section 211 has 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 portion 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 flat and perpendicular to the axial direction. When the loading section 211 is in the combined state, the proximal end face of the loading portion 216 abuts against the base 10. Specifically, in combination with the aforementioned embodiment, the proximal end face of the loading portion 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.

[0456] The locking element moves distally during the rotational unlocking process. In one embodiment, when the loading section 211 and the locking element 13 are engaged, the linkage key and the linkage groove have an axial clearance L1 in the axial direction to allow the connection portion to move distally. Similarly, the proximal end surface of the guide head has the same axial clearance L1 from the positioning portion 131 as described above. The axial clearance L1 is greater than the amount of distal movement of the locking element 13.

[0457] As shown in Figure 35, a tubular extension tube 27 extending from the base is fixed to the distal end of the first shaft 21. The locking element 13 is sleeved around the outer circumference of the extension tube 27, and the loading section 211 is disposed 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 that of the extension tube 27. The distal end of the first shaft 21 extends close to the base 10, while the proximal end extends the same diameter and is connected to the control handle. The larger diameter of the extension tube 27 facilitates force transmission and control. The thinner diameter of the extension tube 27 facilitates the arrangement of components such as the distal locking assembly and the loading section, reducing the overall radial size. The proximal end of the extension tube 27 extends into the base and is fixedly connected to the first shaft 21. In the following embodiments, unless otherwise specified, the extension tube 27 is considered part of the first shaft 21.

[0458] As shown in Figures 35 to 38, an embodiment of the present application further provides a loading structure for an artificial implant. The artificial implant 60 includes an inner frame 61, and a plurality of arms 63 are provided on the outer periphery of the inner frame. A first gap that can accommodate native tissue is formed between each arm 63 and the inner frame 61. The loading structure includes a first shaft 21 and a loading section 211. The inner frame 61 is sleeved on the outer periphery of the first shaft 21 in 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. The entire inner frame 61 or at least the distal part of the inner frame 61 is accommodated in the loading section 211. The peripheral wall of the loading section 211 is provided with an avoidance opening 217, and at least a portion of the arm 63 is located at the avoidance opening 217.

[0459] The loading section 211 restrains the distal end of the artificial implant 60, maintaining it in a collapsed position to ensure safe interventional delivery. Part of the arm portion 63 enters the escape opening 217, located in the region of the loading section 211 with the largest radial space, namely, the aforementioned loading portion 216. Compared to existing structures that completely enclose the artificial implant, the radial dimension of the loading section of this embodiment is smaller, facilitating interventional delivery.

[0460] 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:

[0461] As shown in FIG36a , the arm portion 63 is at least partially located within the loading section 211 ; the loading section 211 is moved axially to release the restraint of the loading section 211 . If there is a catheter sheath wrapped around the loading section 211 , the catheter sheath 70 needs to be moved first.

[0462] Alternatively, as shown in Figures 36b and 36c, the loading structure includes a guide sheath 70, which is slidably mounted on the outermost side of the inner shaft assembly, with the arm 63 positioned between the loading section 211 and the guide sheath 70. By moving the guide sheath 70, the restraint on the arm 63 can be released. In one embodiment, the distal end of the artificial implant is positioned within the loading section, while the proximal end is positioned outside the loading section and within the guide sheath.

[0463] The outflow side 632 of each arm 63 is fixedly connected to the inner frame 61. After expansion, the inflow side 631 forms a first gap with the inner frame 61, and the inflow side 631 is located at the avoidance opening 217. The artificial implant includes an inner frame that defines a blood flow channel. The inner frame has multiple arms on its periphery. Each arm forms a first gap with the inner frame to accommodate native tissue. The inner frame is connected to the leaflets that control the blood flow channel. The inner frame 61 and the arms 63 can be fixed separately or as an integral structure. The inner frame 61 and the arms 63 are cut integrally from a tubular blank. Along the axial direction of the tubular blank, the inflow sides of the inner frame 61 and the arms 63 are separated from each other. The inner frame 61 is a radially deformable cylindrical structure with a blood flow channel 604 inside. The leaflets are connected to the inner frame 61 to adjust the degree of opening of the blood flow channel. The arms 63 themselves are integral annular structures, and the outflow side 632 of each arm 63 is fixedly connected to the inner frame 61.

[0464] As shown in Figures 39 to 41, an 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 720 (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 720 and further extends proximally; the distal end of the inner shaft assembly is provided with a loading section for connecting to 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 720 and the distance between the control handle 3 and the fixing seat 720 is adjustable. The catheter sheath 70 of this embodiment is used to assist in the recovery of the artificial implant.

[0465] The specific length of the catheter sheath can reach a more distant surgical site and wrap the control mechanism, the proximal portion 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 tubular body 51, and the tubular body 51 includes a main section 510 and a deformable section 520. The fixing seat 720 is connected to the proximal end of the main section 510, and the deformable section 520 is located at the distal end of the main section 510. The deformable section 520 includes a plurality of elastic sheets 521 arranged at intervals along the circumference of the tubular body 51. Each elastic sheet 521 has a relative initial state (Figure 42) and an expanded state (Figure 43). In the expanded state, the distal ends of each elastic sheet 521 are relatively far apart and the deformable section 520 as a whole has a flared structure. In the initial state, each elastic sheet 521 is relatively gathered and the deformable section 520 as a whole is straight or radially retracted. As shown in Figures 45 and 46, when retrieving the artificial implant, the catheter sheath 70 can move distally, or the inner shaft assembly moves proximally, until the deformation segment 520 and the artificial implant 60 interact with each other, and the deformation segment 520 switches to the expanded state to retract the artificial implant into the tube body 51.

[0466] It should be noted here that during the retrieval operation, it is necessary to ensure that the loading section 211 is at the distal end of the artificial implant.

[0467] In one embodiment, the length of the tube 51 is at least 60 cm, for example, in the range of 60 to 90 cm.

[0468] The distal end of the tube body 51 has a pre-molded shape that matches the shape of the aortic arch. This reduces safety risks associated with the catheter sheath 70 during interventional delivery and provides better shape matching once in place. The pre-molded tube body 51 establishes a delivery channel for the bend adjustment assembly and the inner shaft assembly, facilitating their in vivo bending and simplifying their structure, for example by eliminating the number of bend adjustment components. The pre-molded tube body 51 can also work in conjunction with the bend adjustment assembly to achieve more precise bending and centering.

[0469] As shown in Figures 41 and 44, in one embodiment, the fixing seat 720 is a hemostatic valve, which can be made of existing technology. In another embodiment, the fixing seat 720 has a mounting channel 721 that communicates with the catheter sheath 70. The proximal end of the fixing seat 720 is provided with a pipe connector 750 connected to the mounting channel 721. The pipe connector 750 has:

[0470] A main interface 751 , where a seal 752 is provided;

[0471] The branch interface 753 is provided with a one-way valve 754. In one embodiment, the control handle 3 is provided with a bending drive mechanism 37, and the bending adjustment assembly includes:

[0472] The proximal end of the bending sheath 43 is fixed to the control handle 3;

[0473] The bending adjusting member has one end fixedly extending to the distal end of the bending adjusting sheath tube 43 and acting on the catheter sheath, and the other end being controlled by the bending adjusting driving mechanism 37 .

[0474] The distal end of the bending member can be fixed to the distal end of the bending sheath 43, or can be relatively movable. 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, causing the bending sheath to bend. Alternatively, the bending member can include a bending tube and a bending wire connected to the bending tube, with the bending wire driving the bending tube to bend the bending sheath.

[0475] The distal end of the bending member is fixed to the bending sheath 43, and the proximal end is controlled by the bending drive mechanism 37 and moves relative to it, so that the distal end drives the bending sheath 43 to bend, and then bends the catheter sheath 70, changing the travel path of the distal end of the delivery system.

[0476] As shown in Figures 47 to 51, the bending drive mechanism includes:

[0477] The winding wheel 371 is rotatably mounted on the support body of the control handle 3 (see the following embodiment for details). The proximal end of the bending member 28 is made of a flexible material and is wound around the winding wheel 371.

[0478] Knob 372, linked to the winding wheel 371;

[0479] The one-way engaging structure interacts with the winding wheel 371 and / or the knob 372 and has a relative limiting state and a releasing state. In the limiting state, the winding wheel 371 is only allowed to rotate in one direction.

[0480] The bending range is related to the amount of change in the bend adjusting member 28. The bend adjusting member 28 rotates and winds around the proximal end, reducing the axial length of the control handle 3 and increasing the bending range. The one-way locking structure is in a limited position when no force is applied, preventing accidental knob movement and limiting rotation to maintain the correct orientation of the bend adjusting sheath 43.

[0481] The rotation axis of the winding wheel 371 is perpendicular to the axial direction of the control handle, wherein the winding wheel 371 has a first direction of bending when rotating, and a second direction of resetting by the bending member 28. The direction of unidirectional rotation is the first direction, and the unidirectional locking structure can limit the rotation of the winding wheel 371 in the second direction before being released.

[0482] In one embodiment, as shown in the figure, the one-way engaging structure includes:

[0483] The ratchet 3711 is coaxially fixed to the winding wheel 371, for example, using an integrated structure;

[0484] A limiting member 374 is movably mounted on the support body 330 and has a pawl 3741 that cooperates with the ratchet;

[0485] The elastic member 375 acts on the limiting member 374 to make the pawl 3741 engage with the ratchet wheel 3711;

[0486] The dial button 376 is movably mounted on the support body 330 and cooperates with the limiting member 374 to drive the limiting member 374 to move so that the one-way engaging structure is in a limited state or a released state.

[0487] The dial button 376 at least partially extends out of the support body 330 to the control handle for operation by an operator.

[0488] As shown, the limit member 374 is rotatably mounted on the support body 330. The limit member 374 and the dial button 376 are integrally formed or separately fixed. During normal operation, the one-way engaging structure is switched to the released state by toggling the dial button 376. After releasing the dial button 376, the elastic member 375 returns the structure to the limited state.

[0489] If the limiter 374 fails to return to its original position, for example due to a failure of the elastic member 375, this out-of-control state can also be determined by the fact that after releasing the dial button 376, the dial button fails to return to its original position and enters a free-moving state. In this case, the dial button 376 needs to be controlled to directly act on the limiter 374 to control the state of the one-way engaging structure. This serves as an emergency relief measure to improve surgical safety.

[0490] In one embodiment, the inner shaft assembly includes a first shaft 21, a second shaft 23, and a third shaft 25, which are slidably sleeved from the inside out. The distal end of the first shaft 21 is linked to a locking element 13, the distal end of the second shaft 23 is connected to a pull wire 11, and the distal end of the third shaft 25 is fixed to a base 10. The locking element 13 is movably mounted on the base 10, and the base 10 is provided with a locking hole 105 that cooperates with the locking element 13. The pull wire 11 is guided from the second shaft 23 through the artificial implant 60 and then restrained to the base 10 by the locking element 13. The proximal ends of the second shaft 23 and the first shaft 21 slide relative to the third shaft 25. The corresponding control method is described in the following embodiment.

[0491] One embodiment of the present application further provides a control method for an interventional delivery system, the system being used for interventional delivery of the artificial implant of the aforementioned embodiment, the delivery system further comprising the control mechanism and control handle of the aforementioned embodiment, and an inner shaft assembly connecting the control handle, the control mechanism, and the loading section. The control method comprises:

[0492] First, expanding at least a portion of the arm to align the first gap with the native tissue;

[0493] Driving the loading section 211 distally to separate from the inner frame 61, so that the distal portion of the inner frame 61 expands;

[0494] By releasing the portion of the pull wire 11 exposed to the base, the proximal end of the inner frame 61 is expanded, so that the inner frame as a whole is deformed to the desired extent, and the pull wire 11 is always kept in control of the inner frame 61 during the process;

[0495] Move the loading section 211 proximally so that the loading section 211 enters the blood flow channel 604;

[0496] The connection between the pull wire 11 and the inner frame 61 is released.

[0497] Detailed description is given with reference to the accompanying drawings:

[0498] After the artificial implant is delivered to the predetermined location within the body, the loading segment 211 is driven distally, or the guide sheath or its internal structure is driven distally, causing the two to move axially in opposite directions (depending on the different arm configurations) until at least a portion of the arm is released and expanded. The distal end of the internal frame remains constrained by the loading segment 211, and the first gap is aligned with the native tissue. This embodiment is described using the embodiment in which the arm is disposed between the loading segment and the guide sheath 70 as an example, with reference to the accompanying drawings:

[0499] As shown in FIG52a and FIG52b, the catheter sheath 70 is driven to move proximally or the internal structure of the catheter sheath is driven to move distally to release the restraint of the catheter sheath on the arm portion 63, and the arm portion 63 expands radially outward.

[0500] As shown in FIG52c, the first shaft 21 is pushed distally to release the restraint of the loading section on the artificial implant, that is, the distal end of the inner frame loses restraint and expands radially outward, and then the proximal end of the inner frame is prepared to expand.

[0501] As shown in Figures 52d and 52e, the third shaft 25 is kept stationary, and the second shaft 23 is pushed toward the distal end, so that the control end 113 of the pull wire 11 moves 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 Figure 52d, the artificial implant 60 is in an expanded state (i.e., the expected amplitude), and after confirming that it is in the expected fit with the surrounding tissue, the pull wire can be released.

[0502] When the pull wire is released, as shown in Figure 52f, 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 pull wires 11 are released in turn until all free ends 111 are completely separated from the locking element 13.

[0503] 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 eyelet 603, that is, completely separated from the artificial implant, which can also be understood as releasing the artificial implant.

[0504] Finally, as shown in Figure 52g, the entire delivery system is withdrawn from the body.

[0505] 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, guiding the loading section 211 to smoothly retract into the blood flow channel, reducing or eliminating the safety risk of the loading section 211 being hung on the distal end of the artificial implant during retraction.

[0506] 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.

[0507] During the initial retrieval phase, there's a gap between the distal end of the catheter sheath and the proximal end of the implant, or they're already in contact. In this state, a significant force exists between the catheter sheath and the implant, which is fed back to the control handle, causing the operator to experience a noticeable damping force. In this state, the implant is retrieved using the telescopic assembly and ejection drive mechanism described in the following embodiments.

[0508] 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.

[0509] It should be noted that the position of the axis in the figure is not limiting, and 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 cable control, the control end of the cable can also be extended and directly controlled by the control handle.

[0510] The above-mentioned control handle can adopt a conventional control handle. This specification provides another control handle, as shown in Figures 53 to 56. 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 pushing mechanism. The pushing mechanism includes a telescopic component 38 and a pushing drive mechanism 39. The distal end of the telescopic component 38 is provided with a stop member 384, and the proximal end is axially movably connected to the control handle 3. The pushing drive mechanism 39 is installed on the control handle 3 and is linked to the proximal end of the telescopic component 38.

[0511] The telescopic assembly 38 is used to adjust the distance between the abutment 384 and the catheter sheath in the aforementioned embodiment, and is capable of maintaining the abutment in any position. The telescopic assembly 38 can maintain the distance between the abutment 384 and the catheter sheath, facilitating interventional delivery operations. When retrieving the artificial implant, the abutment 384 is driven distally until it abuts the proximal end of the catheter sheath, and then the inner shaft assembly is driven proximally relative to the catheter sheath 70 until the artificial implant is retrieved into the catheter sheath 70;

[0512] 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.

[0513] 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 shortens the distance between the catheter sheath and the artificial implant. The inner shaft component is then retracted until the artificial implant is also located in the area. Finally, the push-up drive mechanism 39 completes the recovery of the artificial implant according to the above operation.

[0514] The telescopic assembly 38 can move quickly to eliminate the distance between the abutment member 384 and the catheter sheath, which is a coarse 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.

[0515] 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 has a stopper 384 , and the proximal end of the final stage 383 is linked to the ejection drive mechanism 39 .

[0516] As shown in Figures 54 to 61, in one embodiment, each stage of the telescopic assembly 38 is a cylindrical structure that is movably connected in sequence. This ensures the adjustable distance while saving axial space and reducing the axial size of the control handle. Adjacent stages are composed of an outer tube and an inner tube. When the telescopic assembly 38 is extended, the inner tube moves distally relative to the outer tube. Conversely, when the telescopic assembly 38 is shortened, the inner tube moves proximally relative to the outer tube. The telescopic assembly 38 has a first limit of maximum length and a second limit of minimum length. The telescopic assembly 38 comprises, from inside to outside, a first stage 381, an intermediate stage 382, ​​and a final stage 383.

[0517] In one embodiment, mutually cooperating stop structures are provided between adjacent stages. These structures at least restrict the proximal movement of the inner cylinder relative to the outer cylinder, requiring the stop structure to be released during operation. Furthermore, the stop structure may restrict or merely provide a certain resistance to distal movement of the inner cylinder relative to the outer cylinder, for example, releasing the stop structure's restriction by applying a manual external force.

[0518] The anti-retreat structure includes:

[0519] The rack 3862 is arranged outside the inner cylinder along the extension direction;

[0520] An operating button 387 is swingably mounted on the outer cylinder. On either side of the operating button 387's swing axis are an operating portion 3871 and a locking portion 3872. The locking portion 3872 engages with the rack 3862 to restrict movement between adjacent stages. The operating portion 3871, exposed from the outer cylinder, is used to release the locking portion 3872 from engagement with the rack 3862.

[0521] The elastic member 388 acts on the operating button 387 to drive the engaging portion 3872 to maintain engagement with the rack 3862 .

[0522] Pressing the operating portion 3871 releases the restraint mechanism (i.e., unlocks it). Once released, the operating button 387 is reset by the elastic member 388 and engages (i.e., locks) the rack 3862. The elastic member 388 abuts between the inner wall of the outer cylinder and the radially outer side of the engaging portion 3872. The engaging portion 3872 has a self-locking surface 3873 that cooperates with the rack 3862. The self-locking surface 3873 faces the distal end and is approximately perpendicular to the axial direction of the outer cylinder. The first stage 381 and the intermediate stage 382 are provided with racks, while the intermediate stage 382 and the final stage 383 are provided with the operating button 387 and the elastic member 388, which is a spring.

[0523] In a preferred embodiment, there are two symmetrically arranged operating buttons 387, which move toward each other to perform unlocking and locking operations. There are two corresponding racks 3862 arranged accordingly, which can achieve a better locking effect.

[0524] In one embodiment, the tooth tips of the rack 3862 are inclined toward the proximal end, and the tooth surfaces toward the proximal end drive the locking portion 3872 to self-lock. Therefore, the retaining structure is only a one-way retaining structure, allowing the operator to quickly extend the telescopic assembly 38 without unlocking the retaining structure. When the inner tube reaches its first limit, it is constrained by the outer tube and stops extending. Specifically, an elastic snap 3863 is provided at the proximal end of the inner tube, and a blocking portion 3851 is provided within the inner cavity of the outer tube to abut against the elastic snap 3863 and prevent the inner tube from dislodging. During assembly, the elastic snap 3863 deforms, allowing the inner tube to be inserted into the outer tube, extending to its first limit, at which point the blocking portion 3851 abuts against the elastic snap 3863.

[0525] In one embodiment, the elastic buckle 3863 is disposed at the proximal end of the inner tube, and the blocking portion 3851 is disposed at the distal end of the outer tube. The blocking portion 3851 is the inner cavity wall of the outer tube.

[0526] In one embodiment, a sliding guide structure is provided between the inner and outer cylinders, specifically comprising an axially extending guide groove 3852 provided in one of the cylinders, and a guide strip 3864 provided in the other cylinder, cooperating with the guide groove 3852. In one embodiment, a resilient buckle 3863 is provided at the proximal end of the guide strip, and the distal bottom wall of the guide groove serves as a blocking portion 3851.

[0527] In one embodiment, the distal end of each inner tube has an expanded diameter portion 3861 that is exposed at the second extreme to the distal end of the adjacent outer tube. The operator can grasp the expanded diameter portion to quickly move the corresponding stage distally. At the second extreme, the inner tube's expanded diameter portion 3861 abuts the distal end of the adjacent outer tube. The abutment member 384 also serves as the expanded diameter portion 3861 of the first stage (i.e., the inner tube). The distal end of the final stage (i.e., the outer tube) has an expanded diameter portion 3861 that is exposed at the second extreme to the distal end of the control handle. An operating button 387 and an elastic member 388 are mounted on the expanded diameter portion 3861.

[0528] In one embodiment, the ejection drive mechanism includes:

[0529] The external thread section 3831 is located on the outer periphery of the final stage 383;

[0530] The first driving sleeve 351 is rotatably mounted on the control handle 3 and has an internal thread segment that engages with the external thread segment.

[0531] In one embodiment, a method for controlling the recovery of an artificial implant using an interventional delivery system is provided, comprising:

[0532] Provided are an artificial implant and an interventional delivery system for delivering the artificial implant, the interventional delivery system comprising:

[0533] A catheter sheath is used to construct an intervention channel, and the proximal end of the catheter sheath is provided with a fixing seat;

[0534] an inner shaft assembly having a loading section at its distal end, wherein the artificial implant is at least partially located in the loading section before expansion and is releasably connected to the inner shaft assembly;

[0535] 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;

[0536] The artificial implant at least partially remains connected to the inner shaft assembly. When recovering, the catheter sheath is driven to move relative to the inner shaft assembly, so that the artificial implant is received in the catheter sheath.

[0537] The proximal end and the distal end of this embodiment are not strictly limited to installation positions, but can also be position indications, for example, the ejection mechanism can be extended to a control handle.

[0538] 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 operation. During recovery, a push-up mechanism or other components can be used to abut against the proximal end of the fixed seat to provide sufficient force transmission to facilitate the 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, driving the push-up mechanism to abut against the fixed seat, first using the telescopic assembly to extend toward the distal end until the head abuts against the fixed seat, then controlling the push-up drive mechanism 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.

[0539] The expansion of at least a portion of the artificial implant relative to the inner shaft assembly is understood to mean deformation and outward expansion, or expansion after the distal end is separated from the loading section or the catheter sheath, etc.

[0540] In one embodiment, the artificial implant is connected to the inner shaft assembly via a pull wire. During retrieval, the pull wire is kept in a tightened state to gather the proximal side of the artificial implant, which facilitates smooth entry of the proximal end of the artificial implant into the catheter sheath during retrieval. Prior to retrieval, the artificial implant may be in an expanded state, in which case the pull wire needs to be tightened to gather the proximal side of the artificial implant. During retrieval, the proximal end of the artificial implant's arm enters the catheter sheath first, and the distal end of the arm enters the catheter sheath as the catheter sheath adapts to movement relative to the artificial implant.

[0541] In one embodiment, a method for loading an artificial implant into a delivery system is provided, comprising:

[0542] Provided are an artificial implant and a delivery system, wherein the artificial implant includes an inner frame with a plurality of arms on the outer periphery of the inner frame. The delivery system includes:

[0543] a guide sheath with a fixing seat at the proximal end;

[0544] 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;

[0545] A control handle is connected to the proximal end of the inner shaft assembly.

[0546] 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.

[0547] Prior to loading, the artificial implant is in an expanded state and separated from the delivery system. In one embodiment, a pull wire is threaded through the proximal end of the inner frame to connect the artificial implant to the delivery system. Referring to the aforementioned structure, the delivery system further includes a control mechanism comprising a base connected to the inner shaft assembly, a locking member movably engaged with the base, and a plurality of pull wires; the inner shaft assembly is similar to the aforementioned embodiment.

[0548] One end of the cable (i.e., the control end) is connected to and controlled by the control handle, while 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 sufficient length for the cable to pass around the proximal end of the inner frame and return to the corresponding locking area of ​​the base, waiting to be locked to the base and the locking element. Multiple cables are locked one by one. During the locking process, the locking element moves in a rotational manner relative to the base.

[0549] Next, the control handle is operated to move the control end of the pull wire toward the proximal end to tighten the pull wire, shortening the length of the pull wire exposed outside the base and radially compressing the proximal end of the inner frame until it is close to the base. During the tightening process, all pull wires are tightened simultaneously.

[0550] Next, the far end of the inner frame is compressed and loaded:

[0551] In one embodiment, the distal end of the inner frame is compressed, and a control handle is operated to move the loading section proximally to accommodate the distal end of the inner frame. At this point, the arms remain expanded and unaccommodated by the loading section. The control handle is then operated to move the catheter sheath distally to accommodate the arms and the proximal end of the inner frame. The inner frame can be compressed using a crimping device in a cold water bath or manually.

[0552] In another embodiment, the distal ends of the inner frame and the arm are compressed, and the loading section is driven by the operating control handle to move proximally to accommodate the distal end of the inner frame and at least the distal portion of the arm. The control handle is then operated to drive the catheter sheath to move distally to accommodate the proximal end of the inner frame and the exposed portion of the arm. The method of compressing the inner frame and the arm can be through a crimping device in a cold water bath or manual compression. 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 around 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 fixed seat distally relative to the control handle.

[0553] In the two aforementioned embodiments, the loading section includes a clearance opening. During the process of accommodating the distal end of the inner frame, the clearance opening is first aligned circumferentially with the arm. The circumferential alignment method includes operating a control handle to drive the loading section to rotate circumferentially. As shown in Figures 62 to 64, the present application further provides a control handle 3, which is connected to a control catheter assembly 4 and includes:

[0554] The support body 330 includes two rigid bars 333 arranged side by side, and a guide channel 334 is defined between the two rigid bars 333;

[0555] 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 engaged with the transmission member 340 .

[0556] The support body utilizes two rigid bars. These bars connect radially opposite sides of the guide channel, facilitating radial installation of the transmission component. The guide channel also connects axially, ensuring the required movement of the transmission component. Furthermore, compared to existing support body structures, the bar structure is more easily machined and free from material limitations. For example, the rigid bars 333 can be made of sheet metal, effectively enhancing the structural strength of the support body.

[0557] 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 bar can be extended axially accordingly to meet the installation requirements of the redundant 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.

[0558] 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 length of both rigid bars 333 is the length along the axial ends. The total length of the control handle is the length when the control handle is fully extended, that is, starting from the distal end surface of the first drive sleeve 351 and ending at the proximal end surface of the force-applying member 355 in the embodiment described below.

[0559] In one embodiment, a plurality of weight-reducing holes 336 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 lowering friction and making the movement of the transmission member smoother.

[0560] In one embodiment, the distal end of the rigid bar extends into the telescopic assembly 38, and specifically, the distal end of the rigid bar extends close to the head stage.

[0561] In another embodiment, the catheter assembly 4 includes a first group and a second group that are movably sleeved from the outside inward. The control handle 3 includes a first handle 310 and a second handle 320. The first handle 310 is used to connect the first group, and the second handle 320 is used to connect the second group. The first handle 310 and the second handle 320 both include a support body 330. Each support body 330 includes two rigid bars 333 arranged side by side. The first handle 310 and the second handle 320 can share the same support body (as shown in FIG. 63 ), or the first handle 310 and the second handle 320 can have different support bodies. When the first handle 310 and the second handle 320 are separated from each other and the distance between them is the longest, the control handle is in a fully extended state.

[0562] As shown in Figures 63 to 67, in one embodiment, the rigid bar 333 includes a block 335 that engages with the first handle 310 and / or the second handle 320. To maintain the relative fixation between the rigid bar and the corresponding handle, the corresponding handle is provided with a slot 337 that engages with the block 335. This engagement mechanism also applies to other components, such as transmission elements. For example, when the first handle 310 and the second handle 320 are movable together (the two handles experience relative movement in the axial and / or circumferential directions), the rigid bar 333 is fixedly connected to one handle via the block 335, while it is in a sliding and / or rotational engagement with the other handle.

[0563] In one embodiment, the control handle 3 includes a mounting base 360 ​​connected and fixed to the two rigid bars 333. The drive sleeve 350 is inserted into the rigid bars 333 and rotates in conjunction with the mounting base 360. The mounting base 360 ​​is provided with a slot 337 that mates with the block 335 and provides a mounting base for the drive sleeve while maintaining the relative fixation between the two rigid bars. The modular installation is further described below:

[0564] Mounting base 360 ​​consists of two radially interlocking parts. Before installing the drive sleeve, the two parts are first fastened to the support body, then the transmission component is inserted into the guide channel. Finally, the drive sleeve is installed and coupled to the transmission component. The installation direction of mounting base 360 ​​and the transmission component do not interfere with each other, and there is no strict order for the two to be installed, providing greater flexibility.

[0565] The first handle 310 and the second handle 320 share a support body, wherein the second handle 320 is fixedly connected to the support body and slides relative to the first handle 310. The first group of the catheter assembly 4 includes a bending sheath 43, and the second group includes a first shaft 21, a second shaft 23 and a third shaft 25; the plurality of drive sleeves include, from distal to proximal, the following:

[0566] The first driving sleeve 351 is used to control the movement of the telescopic assembly 38 with reference to the previous embodiment;

[0567] The second driving sleeve 352 is provided on the first handle 310 and is used to control the second handle 320 to slide axially relative to the first handle 310;

[0568] A third driving sleeve 353 is provided on the second handle 320 and is used to control the axial movement of the second shaft 23;

[0569] The fourth driving sleeve 354 is disposed on the second handle 320 and is used to control the axial movement of the first shaft 21 .

[0570] The multiple transmission parts include:

[0571] The first transmission member 341 is fixedly connected to the support body 330, fixed to the third shaft 25 and threadedly engaged with the second drive sleeve 352;

[0572] The second transmission member 342 is slidably mounted in the guide channel 334, fixedly connected to the second shaft 23 and threadedly engaged with the third driving sleeve 353;

[0573] The third transmission member 343 is slidably mounted in the guide channel 334 , fixedly connected to the first shaft 21 and threadedly engaged with the fourth driving sleeve 354 .

[0574] In one embodiment, multiple mounting blocks 360 are provided and arranged axially. The drive sleeve 350 is constrained at its ends by two adjacent bases and rotatably engages with one of the bases. Specifically, the second handle 320 includes, from farthest to nearest, a first mounting block 361, a second mounting block 362, and a third mounting block 363. The third drive sleeve 353 is nested within the first mounting block 361 and constrained at its ends by the first and second mounting blocks 361 and 362. The fourth drive sleeve 354 is nested within the second mounting block 362 and constrained at its ends by the second and third mounting blocks 362 and 363.

[0575] The first mounting seat 361 is disposed at the distal end of the second handle 320, and the third mounting seat 363 is disposed at the proximal end of the second handle 320. Regarding the structure of the drive sleeve 350 itself, the drive sleeve 350 includes a drive ring 356, and a first locking ring 357 and a second locking ring 358 connected to the axial ends of the drive ring 356. The drive ring 356 is composed of two lobes that interlock with each other. The first locking ring 357 is threadedly connected to the drive ring 356, and the second locking ring 358 is sleeved on the drive ring 356.

[0576] In one embodiment, the driving sleeve 350 includes an operating portion 3561 and a docking portion 3562 embedded in the mounting seat 360 along its own axial direction. The mounting seat 360 separates the operating portions 3561 of two adjacent driving sleeves 350 from each other to reduce the probability of misoperation.

[0577] In one embodiment, the first transmission member 341 is disposed at the distal end of the first handle 310, specifically, for example, at the distal end or proximal end of the first mounting base 361. The first transmission member 341 is directly or indirectly connected to the support body 330. For example, the first transmission member 341 is directly and fixedly connected to the support body 330, or the first transmission member 341 is fixedly connected to the first mounting base 361 (indirect connection).

[0578] As shown, the first mounting base 361 has a connecting sleeve 364 that extends distally into the first handle 310, and the first transmission member 341 is disposed at the distal end of the connecting sleeve 364. The connecting sleeve 364 is fixedly connected to the support body and wraps around the outer periphery of the support body 330, serving as a guide for the second handle to slide relative to the first handle and covering the support body.

[0579] In one embodiment, the rigid strip has a greater width dimension in a section of the second handle than in a section of the rigid strip in the first handle.

[0580] In another embodiment, as shown in Figures 68 to 70, the support bodies of the first handle 310 and the second handle 320 are not shared, that is, the first handle 310 includes a first support body 331, and the second handle 320 includes a second support body 332. The second handle 320 is movably engaged with the first handle 310. Specifically, the second handle 320 rotates and slides axially relative to the first handle 310. The configuration of each drive sleeve refers to the aforementioned embodiment.

[0581] The proximal end of the first handle 310 is provided with a sliding seat 345 that is threadedly engaged with the second drive sleeve 352. The sliding seat 345 is fixedly connected to the first support body 331. The first mounting seat 361 of the second handle 320 is rotatably engaged with the sliding seat 345, with a snap-fit ​​structure between the two to limit axial movement. The third shaft is fixedly connected to the first mounting seat 361. Rotation of the second handle 320 relative to the first handle 310 allows the artificial implant at the distal end to rotate with the control mechanism, thereby adjusting the spatial posture of the artificial implant.

[0582] In the figure, the connecting sleeve 364 of the first mounting seat 361 is rotatably engaged with the sliding seat 345. The proximal end of the third shaft passes through the sliding seat 345 and is fixed within the connecting sleeve 364. The first support body 331 is fixedly connected to the sliding seat 345, and the second support body 330 is fixedly connected to the first mounting seat 361, the second mounting seat 362, and the third mounting seat (not visible in the assembled state). The distal end of the first support body 331 extends to near the head of the telescopic assembly, while the proximal end of the second support body 332 extends to the connecting sleeve 364 and is close to the sliding seat 345.

[0583] The width of the rigid strip corresponding to the second support body is larger than that of the rigid strip corresponding to the first support body.

[0584] As shown in Figures 70 to 73, in one embodiment, the sliding seat 345 is composed of two lobes that are interlocked and a ring 3452 that is mounted on the outer periphery of the two lobes to limit the separation of the two lobes. Both lobes are provided with a slot 337 that engages with the first support body.

[0585] As shown in Figures 74 to 80, in one embodiment, a rotating locking mechanism that cooperates with each other is provided between the sliding seat 345 and the connecting sleeve 364. The locking mechanism has:

[0586] In the locked state, the second handle 320 is restricted from rotating relative to the first handle 310; in the unlocked state, the second handle 320 is allowed to rotate relative to the first handle 310. That is, when rotating the second handle 320, it is necessary to first unlock the rotation locking mechanism to prevent misoperation.

[0587] The rotation locking mechanism includes:

[0588] The meshing teeth 3451 are located on the end surface of the proximal end of the sliding seat 345 and are distributed around the rotation axis of the connecting sleeve 364;

[0589] The unlocking member 346 is movably mounted on the connecting sleeve 364 and has a locking position in which it cooperates with the meshing teeth 3451 and an unlocking position in which it is radially separated from the meshing teeth 3451;

[0590] Actuating member 347 acts on unlocking member 346, maintaining it in the locked position. The proximal end of the unlocking member is swingably mounted on a connecting sleeve 364. Connecting sleeve 364 defines an operating window 348, through which at least a portion of unlocking member 346 is exposed, facilitating operation and control.

[0591] In one embodiment, unlocking members 346 are arranged in pairs along the radial direction of the connecting sleeve 364, and the driving member 347 is elastically compressed between the unlocking members 346. As shown, the connecting sleeve 364 includes a base 3641 extending axially between the two unlocking members 346. The driving member 347, such as a spring, is elastically compressed between the unlocking members 346 and the base 3641. A guide step 3642 is provided within the connecting sleeve 364. The unlocking members cooperate with the guide step and are guided radially inward by the guide step, tending to move toward the unlocked position.

[0592] The tooth shape of the meshing teeth 3451 gradually converges toward the proximal end, such as a triangle.

[0593] In one embodiment, a radially extending guide groove 3462 is defined on the inner wall of the connecting sleeve, and at least a portion of the unlocking member 346 moves along the guide groove 3462 .

[0594] The unlocking member 346 includes:

[0595] The pressing portion 3463 is exposed to the operation window 348;

[0596] The swing shaft 3464 is located on the proximal side of the pressing portion 3463;

[0597] The guide portion 3465 is located at the distal end of the pressing portion 3463 and cooperates with the guide groove 3462;

[0598] The locking portion 3466 is located on the distal side of the guide portion 3465 and engages with the meshing teeth 3451. The locking portion 3466 is tapered as a whole and converges toward the distal end.

[0599] In one embodiment, at least a portion of the unlocking member 346 is exposed from the connecting sleeve 364. This exposed portion is exposed to the first handle 310 or retracted into the first handle 310 as the second handle 320 axially moves. For example, when the unlocking member 346 is in the locked position, the exposed portion is flush with the outer circumference of the connecting sleeve 364, facilitating the retraction of the connecting sleeve 364 into the first handle 310 when the second handle 320 slides distally.

[0600] As shown in Figures 81 to 84, the present application also provides a control handle 3 for controlling a catheter assembly to operate an artificial implant. The catheter assembly includes multiple shafts that are slidably nested inside and outside. The control handle 3 includes a support body 330, a transmission member 340 arranged on the support body 330 and fixed to each shaft, and a drive sleeve 350 rotatably mounted on the support body 330 and threadedly driven with the transmission member 340. Among the multiple shafts, the first shaft 21 is in the innermost layer. The proximal end of the first shaft 21 is connected to a fourth transmission member 344 and a force-applying member 355 that slides relative to the support body 330. The first shaft 21 slides axially so that the force-applying member 355 has a first position at least partially hidden in the support body 330, and a second position exposed outside the support body. The force-applying member 355 can drive the first shaft 21 to rotate.

[0601] In conjunction with the foregoing, when in the first position, the force-applying member 355 is at least partially located within the second handle. In the second position, the force-applying member 355 has a greater exposed portion than in the first position, facilitating operation. When the force-applying member 355 is in the first position, the overall length of the control handle 3 is shortened, facilitating packaging and reducing the risk of accidental activation during initial operation.

[0602] The distal end of the first shaft 21 is positioned similarly to the previous embodiment. Specifically, from the time the distal end of the artificial implant is expanded until the loading section and the locking element engage, the force-applying member 355 remains in the first position. This prevents misoperation and circumferential misalignment of the linkage structure, ensuring successful engagement of the loading section and the locking element. Accordingly, when the force-applying member 355 is in the second position, the loading section and the locking element engage.

[0603] In one embodiment, the force-applying member 355 is fixedly connected to the first shaft 21 and is in transmission engagement with a fourth transmission member. The transmission engagement between the force-applying member 355 and the fourth transmission member includes synchronous axial movement to accommodate axial movement of the distal end of the first shaft, such as the loading section, and rotation of the force-applying member 355 relative to the fourth transmission member to accommodate operations such as releasing a pull wire. In one embodiment, the force-applying member 355 is threadedly engaged with the fourth transmission member.

[0604] The force-applying member 355 is a cylindrical structure comprising an operating section 3551 and a connecting section 3552 disposed distally of the operating section 3551. The connecting section 3552 is connected to the fourth transmission member 344. The connecting section 3552 comprises a first section 3553 that extends into and connects to the fourth transmission member, and an expanded diameter section 3554 connected proximally to the first section. The distal end of the operating section 3551 is provided with a snap-fit ​​portion 3555 that accommodates and circumferentially engages with the expanded diameter section 3554. The proximal end of the first shaft 21 passes through the connecting section 3552 and docks with the operating section 3551.

[0605] The outer circumference of the expanded section 3554 is polygonal. The inner cavity of the engaging portion 3555 cooperates with the outer circumference of the expanded section 3554 to restrict relative rotation between the operating section 3551 and the connecting section 3552. The sidewall of the engaging portion 3555 is provided with an elastic catch 3556 that abuts against the expanded section 3554 to prevent the connecting section 3552 from separating from the operating section 3551. In one embodiment, the operating section 3551 has an axial sliding range relative to the connecting section 3552.

[0606] The connecting section 3552 is a bolt, the first section 3553 has an external thread, and the fourth transmission member has an internal thread matching the external thread.

[0607] In combination with the aforementioned control mechanism, during the process of releasing the pull wire, the locking element will undergo spiral motion accompanied by axial movement toward the distal end, thereby driving the loading section and the first axial distal end connected to the loading section to move. In one embodiment, the connecting section 3552 slides axially relative to the operating section 3551. Specifically, the expanded diameter section 3554 can slide within the engaging portion 3555. During the actual release of the pull wire, the operating section 3551 rotates axially in the first direction, driving the connecting section 3552 to rotate synchronously and move axially toward the distal end relative to the fourth transmission member until the operating section 3551 abuts against the proximal end of the fourth transmission member and the expanded diameter section 3554 abuts against the elastic buckle 3556, thereby limiting the rotation of the operating section. At the same time, all pull wires are released. It should be noted that the axial movement stroke of the connecting section 3552 is adapted to the axial movement stroke when the locking element rotates.

[0608] In one embodiment, the force-applying member 355 is a hollow structure, the proximal end of which can be connected to a Y-shaped valve. The force-applying member 355 extends forward of the distal end of the expanded artificial implant and distally enters the support body 330 during expansion of the artificial implant. This prevents the Y-shaped valve from contacting the control handle. In this position, the axial length of the portion of the force-applying member 355 exposed outside the support body is shorter than the axial length of the portion of the force-applying member 355 exposed outside the support body in the second position. This correspondingly reduces the axial dimension of the control handle, facilitating handling during packaging and interventional delivery.

[0609] Among them, before expanding the artificial implant, although the force-applying component 355 is exposed outside the supporting body, the loading section of the first axis connected to it is limited by the force between the loading section and the artificial implant (such as friction, etc.), and acts in the opposite direction on the force-applying component 355 to limit its rotation, or require a larger driving force to reduce the probability of misoperation.

[0610] The other structures of the control handle refer to the above embodiment, that is, a third mounting seat 363 is provided at the proximal end of the support body 330. In one embodiment, the third mounting seat 363 is a cylindrical structure, and its inner cavity is loosely matched with the outer peripheral surface of the force-applying component 355, serving as a sliding guide for the force-applying component.

[0611] As shown in Figures 85 to 88, this embodiment provides a transmission member 340 for connecting an interventional catheter in a control handle, including a body 3401. The body 3401 has an axially extending through hole 3404 for inserting the interventional catheter. The body 3401 includes:

[0612] A first half body 3402, the outer wall of the first half body 3402 has threaded transmission teeth 3406;

[0613] The second half 3403 is engaged with the first half 3402 , and the through hole 3404 is located between the first half 3402 and the second half 3403 ;

[0614] The fixing member 3405 is surrounded by the first half 3402 and the second half 3403. The fixing member 3405 has an interventional catheter fixing hole 3491 corresponding to the position of the through hole. The outer periphery of the fixing member 3405 and at least one of the first half 3402 and the second half 3403 are provided with a mutually cooperating anti-rotation structure.

[0615] The interventional catheter can be any of the shafts described in the aforementioned embodiments, including, for example, the first and second shafts. The interventional catheter is fixedly connected to the fixing member 3405, for example, by bonding or a tight fit. Once the interventional catheter and the fixing member are connected, the first and second halves 3402 and 3403 are interlocked and wrapped around the fixing member 3405, completing the assembly. The control handle adopts the structure of the aforementioned embodiments, with the assembled transmission member 340 placed within the support body 330 and then threadedly engaged with the drive sleeve via threaded transmission teeth 3406.

[0616] In one embodiment, the through hole 3404 has a first radial direction Y and a second radial direction X, which are perpendicular to each other as shown. The body 3401 has threaded transmission teeth 3406 on both sides along the first radial direction Y. The first half 3402 and the second half 3403 engage with each other along the second radial direction X. In the figure, the first half 3402 has threaded transmission teeth 3406 on both sides of the first radial direction Y, maintaining the integrity of the threaded transmission teeth 3406, facilitating machining and maintaining a precise fit with the drive sleeve.

[0617] In one embodiment, the first half 3402 and the second half 3403 are fastened together by elastic buckles. As shown, the second half 3403 is provided with an elastic buckle 3407 extending along the second radial direction X. The first half 3402 has a groove 3408 that mates with the elastic buckle 3407, thereby ensuring that the two opposing sides of the body 3401 along the second radial direction are smooth and flat, thus mateable with the rigid bars 333 on either side.

[0618] In one embodiment, one of the first half 3402 and the second half 3403 is provided with a positioning slot 3409 extending along the second radial direction X, and the other is provided with a positioning key 3410 that cooperates with the positioning slot for positioning during engagement.

[0619] In one embodiment, the anti-rotation structure is set as follows: the fixing part 3405 is an annular structure, the inner hole of which is the fixing hole 3491 and has a non-circular outer contour, and the first half 3402 and the second half 3403 both have an anti-rotation inner edge that partially or completely fits the outer contour of the fixing part 3405.

[0620] The control mechanisms of the present application can cooperate with each other to realize the control of the expansion, release or recovery process of the artificial implant in the body. The structure has been further optimized and improved to make the control of the pull wire smoother.

[0621] The catheter sheath in the above-described embodiment is used to establish a temporary channel for the delivery system to deliver the artificial implant through the channel to the surgical site. The application location and structure of the artificial implant are not strictly limited. In conjunction with the present application, it should at least have a long axial dimension and be suitable for a long interventional path.

[0622] As shown in Figures 89 to 100, the present application provides a catheter sheath 70 for long-distance intervention, having a distal end 32 and a proximal end 31. The catheter sheath 70 includes a tubular body 51 and a hemostatic valve 55. The tubular body 51 includes a main body section 510 and a deformable section 520. The hemostatic valve 55 is connected to the proximal end of the main body section 510. The main body section 510 has a structural reinforcement layer in its wall, at least near the distal end. The reinforcement layer is a metal tube 511 with a hollow structure.

[0623] The deformable section 520 is located at the distal end of the main section 510 and comprises a plurality of elastic sheets 521 spaced circumferentially along the tube 51. The proximal end of each elastic sheet 521 is connected to the metal tube 511. Each elastic sheet 521 has an initial state ( FIG93 ) and an expanded state ( FIG95 ). In the expanded state, the distal ends of each elastic sheet 521 are relatively separated, and the deformable section 520 as a whole has a flared structure. In the initial state, the elastic sheets 521 are relatively close together, and the deformable section 520 as a whole has a straight cylindrical shape or is radially inwardly contracted.

[0624] The hemostatic valve 55 itself can adopt existing technology including a shell and a seal located in the shell. The seal can be an elastic member or a fluid-driven deformable member to prevent blood leakage when the catheter assembly of the delivery system passes through the hemostatic valve.

[0625] The hemostatic valve 55 has a first connecting channel 551 for injecting fluid to drive the seal and a second connecting channel 552 for exhausting air.

[0626] The length of the catheter sheath of the present application can reach a distant surgical site, and the deformable section can assist in recovering the artificial implant after switching to the expanded state.

[0627] Taking aortic valve replacement as an example, the catheter sheath 70 is inserted through the femoral artery of the lower limb until the distal end of the tube body 51 extends to the aortic arch (e.g., the ascending aorta root). The catheter sheath of this embodiment can establish a long-distance channel, facilitating the delivery of the catheter assembly and prosthetic implant of the delivery system. It can also assist in the recovery of the prosthetic implant.

[0628] Furthermore, since the deformable section can assist in recovering the artificial implant after switching to the expanded state, the structure of the catheter assembly can be further simplified. For example, the outermost tube can be omitted compared to a conventional catheter assembly.

[0629] The proximal end of the artificial implant can be connected to the catheter assembly of the delivery system through a conventional T-shaped connecting ear or through a wire control method, and the proximal end of the artificial implant can be kept restrained before the pull wire is completely released.

[0630] In one embodiment, the length of the tube 51 is at least 60 cm, for example, in the range of 60 to 90 cm.

[0631] In one embodiment, the distal end of the tube body 51 has a pre-molded shape that matches the shape of the aortic arch, thereby reducing safety risks of the catheter sheath during interventional delivery and providing better shape matching after being in place.

[0632] As shown in Figure 3, the distal end of the main body section 510 comprises a three-layer structure, comprising, from outside to inside, an outer membrane layer 513, a reinforcement layer (i.e., a metal tube), and an inner membrane layer 514. The metal tube 511 is cut from a nickel-titanium alloy tube or braided from nickel-titanium alloy wire, forming a hollow structure. This hollow structure not only increases flexibility, facilitating navigation through corners, but also allows for better adhesion of the reinforcement layer to the inner and outer membrane layers. The outer membrane layer 513 and the inner membrane layer 514 can be made of lubricating materials such as Elasthane, Pe11ethane, Pebax, or Grilamide, respectively.

[0633] The distal end of the metal tube 511 is aligned with the distal end of the main body section 510, and the length of the metal tube 511 is as follows:

[0634] The artificial implant is retracted into the tube body 51 , with the distal end of the artificial implant aligned with the main body section 510 , and the proximal end of the metal tube 511 exceeds or is aligned with the proximal end of the artificial implant;

[0635] Or after the catheter sheath 70 is delivered after the intervention, the length of the metal tube 511 is sufficient to cover the aortic arch;

[0636] Alternatively, the metal tube 511 and the main body section 510 may be of the same length.

[0637] As shown in Figure 92, in one embodiment, the catheter sheath 70 includes a bend adjusting member that drives the tube body 51 to bend. The distal end of the bend adjusting member extends and acts on the distal end of the main body section 510 to bend it. The proximal end of the bend adjusting member extends to form a hemostatic valve that is connected to an extension handle controlled by the extension handle. The extension handle is disposed proximal to the hemostatic valve 55, and a locking mechanism is provided between the two to limit the axial positioning of the two. The locking mechanism can be a buckle, etc. The extension handle has a first channel for the delivery system to pass through. The extension handle can also be integrally provided with the hemostatic valve 55.

[0638] The bending member 56 includes a wire, a tube, or a combination of wires and tubes. For example, the bending member 56 is a traction wire, the distal end of which is extended and fixed to the distal end of the main body segment. The extension handle controls the traction wire to act on the main body segment 510 to bend from a dotted line to a solid line.

[0639] In one embodiment, each elastic sheet 521 is integrally connected to the metal tube 511 or connected separately. The integral structure is convenient for processing and forming, and can also improve structural strength.

[0640] In one embodiment, two adjacent elastic sheets 521 are connected by a connector 522. When the deformable section 520 is switched to the expanded state, the connector 522 allows the elastic sheets 521 to interact with each other and expand evenly. This ensures that when the artificial implant 60 is retrieved, the elastic sheets 521 are evenly stressed, preventing excessive deformation of the elastic sheets 521.

[0641] As shown in Figures 93-96, in one embodiment, the connecting member 522 between two adjacent elastic sheets is a single, roughly V-shaped structure with a first opening positioned toward the distal end. A spacing opening 501 is formed between the two adjacent elastic sheets. The spacing opening 501 widens in the middle and narrows at both ends. The elastic sheet 521 gradually widens near its proximal end to enhance connection strength and ensure the necessary resilience. The spacing opening 501 features a curved edge at its proximal end to disperse stress and improve safety.

[0642] In the initial state of each elastic sheet 521 , the middle portion 504 of the connecting member 522 is folded and stored in the interval area between two adjacent elastic sheets; in the expanded state of each elastic sheet 521 , the middle portion 504 of the connecting member 522 is relatively unfolded (relative to the initial state).

[0643] The connection portion between the connector 522 and the elastic sheet 521 is adjacent to the distal end of the elastic sheet 521 , eliminating an isolated end or spike structure of the elastic sheet 521 and preventing the end from poking into the structural gap of the artificial implant.

[0644] Between the end of the connecting piece 522 and the elastic sheet 521 on the corresponding side, the connecting portion adjacent to the distal end of the elastic sheet 521 can be understood as being close to or just at the distal end of the elastic sheet 521. Especially in the expanded state, it can avoid the distal end of the elastic sheet 521 from forming an isolated convex portion, thereby reducing the risk of interference with the artificial implant.

[0645] There is no strict restriction on the shape of the middle part 504. It mainly serves to connect and pull the two connected elastic sheets 521 in the expanded state. In the initial state, the middle part 504 needs to be folded and stored, so a foldable structure is adopted. The folding process can be driven by the elasticity of the elastic sheet 521, or it can be combined with the middle part 504 itself to use a predetermined elastic material to assist in driving the folding. After folding, it is stored between the two adjacent elastic sheets and extends accordingly to the proximal end.

[0646] The connection method between the elastic sheet 521 and the connecting member 522 affects the stress distribution and the folding effect of the connecting member 522. In one embodiment, the distal edge 505 of each elastic sheet 521 is arc-shaped, and the two ends of the connecting member extend roughly along the tangent direction of the arc to connect to the distal edge of the corresponding elastic sheet. With reference to Figure 9, the connecting member 522 has a first section 523 and a second section 524 forming a V-shaped structure, wherein the first section 523 extends toward the distal edge 505 of the elastic sheet 521 along the X1 direction, and the second section 524 extends toward the distal edge 505 of the elastic sheet 521 along the X2 direction, and the first section 523 and the second section 524 intersect and form a single body.

[0647] The arc shape of the distal side edge 505 only expresses the general trend or overall shape characteristics and is not a strict limitation. The various connecting parts extend and intersect in a tangential direction, which provides a better radial contraction force and a more reasonable stress distribution.

[0648] In another embodiment, the first segments 523 and second segments 524 of two adjacent connectors 522 abut against the distal edge of the same elastic sheet, and the distal edge of the abutment is smoothly rounded. This smooth outer edge can mitigate safety hazards. For example, if the first segment 523 and the second segment 524 abut against the distal edge 505 of the same elastic sheet 521, the abutment creates a relatively smooth transition, preventing spikes or protrusions from interfering with the implant.

[0649] Furthermore, all the connectors 522 extend continuously in the circumferential direction of the tube body. As can be seen in the figure, since the adjacent connectors 522 are smoothly connected, all the connectors 522 are connected to form a ring. Although the middle part 504 may have slight bends and undulations, it does not affect the overall trend.

[0650] In the initial state, each elastic piece has two corners on both sides of the middle portion 504 of the connector 522, each of which is provided with a protrusion 506 extending toward the proximal end. The protrusion 506 can strengthen the corner structure and prevent fatigue damage caused by repeated bending.

[0651] When each elastic sheet is in the expanded state, the two protrusions corresponding to the same U-shape are adjacent to or abut against each other. The two protrusions are adjacent to or abut against each other, which can limit the expansion angle of the connecting member 522 and prevent it from folding back in extreme or abnormal situations.

[0652] Between adjacent elastic sheets is a spacing opening 501. In the initial state, the first and second sections 523, 524 of each elastic sheet extend from their respective ends along an arc-shaped path into the spacing opening 501. Specifically, the connector 522 is curved at the distal edge 505 adjacent to the elastic sheet 521, effectively conforming to the shape of the elastic sheet 521 and extending close to the edge of the sheet 521, thus occupying less space. This curved structure also prevents excessive stress concentration during deployment, reducing the potential safety hazard of fatigue fracture.

[0653] In the initial state, the proximal end of each elastic sheet is axially adjacent to the center of the spacing opening 501. In the initial state, the spacing opening 501 is a generally strip-shaped notch, with the distal end sealed by the connector 522. Each elastic sheet 521 can expand radially outward to accommodate the gradual deformation of the artificial implant during expansion and prevent sudden dislodging of the artificial implant at the end of expansion. Furthermore, when retrieval is required, each elastic sheet 521 expands radially outward to form a flared opening to guide the retrieval of the artificial implant.

[0654] When the elastic sheets are in the expanded state, the top angle of the V-shape of the connecting member 522 is greater than or equal to 120 degrees. Of course, in combination with the above, the top angle of the V-shape adopts a rounded structure, which is roughly U-shaped.

[0655] Each elastic piece has a hollow area, and the elastic pieces are arranged along the circumferential direction, with a number of 3 to 6, for example, 5.

[0656] The hollowed-out area 502 of the elastic sheet 521 facilitates deformation and reduces outward expansion resistance. In one embodiment, the hollowed-out area 502 is a strip-shaped hole, a circular hole, an elliptical hole, or a teardrop-shaped hole. Hollowed-out areas 502 may be located in a single location or multiple, isolated locations on the same elastic sheet. Each hollowed-out area has a smooth inner edge, which prevents cracking caused by excessive stress concentration during deformation. The total area of ​​the hollowed-out areas on a single elastic sheet is less than 50% of the sheet's total area. Hollowed-out areas 502 are multiple through-holes, which can be spaced axially or circumferentially on the same elastic sheet.

[0657] The outer film layer 513 and the inner film layer 514 can further extend distally to cover the inner and outer sides of the deformation section 520. To reduce the risk of tearing, the film layer between two adjacent elastic sheets can be cut to release the deformation stress.

[0658] In another embodiment, as shown in FIG. 10 and FIG. 11 , two adjacent elastic sheets 521 are connected to two connecting members 522 , and the two connecting members 522 are respectively a first connecting member 526 and a second connecting member 525 arranged along the axial direction.

[0659] The specific structure of the first connecting member 526 can be referred to in the previous embodiment. In this embodiment, the second connecting member 525 is connected to the axial middle portion (hereinafter referred to as the waist) of the elastic sheet 521. The second connecting member 525 has a V-shaped structure and has a second opening 528, wherein the first opening 527 and the second opening 528 are separated from each other.

[0660] The V-shaped inflection point of the second connecting member 525 has a relatively clear turning trend, and the second opening 528 is oriented toward the proximal end, which can reduce the resistance and hidden dangers caused by the outward warping of the inflection point during retraction. The first connecting member 526 and the second connecting member 525 have different deformation amounts, which limit the different radial deformation amounts of the elastic sheet at the connection point. This makes the deformation section 520 as a whole present an arc-shaped cone, reducing the bending angle at the turning point between the deformation section and the main section.

[0661] The waist of the elastic piece 521 is circumferentially retracted inward compared to its distal and proximal ends, and the root of the second connecting member 525 transitions to the waist in an arc shape.

[0662] When the catheter assembly and the artificial implant are pushed distally in the catheter sheath, in order to avoid potential resistance caused by the two protrusions 506, the apex 529 of the second connecting member 525 is located inside the two protrusions 506, which can play a guiding role.

[0663] In another embodiment, as shown in FIG12 , different from the above embodiment, the deformable section 520 is in a grid structure as a whole, and the elastic sheet 521 can be understood as a partial grid structure in the circumferential direction. The deformation of the grid structure can adapt to the switching of the elastic sheet state.

[0664] As shown in Figures 101 and 102, in another embodiment, adjacent elastic sheets 521 are connected at their midsections to form a connecting portion 581. This connecting portion 581 defines a first opening 582, which serves to release stress when the deformable segment 520 expands or contracts. The first openings 582 are circular holes, and there are multiple of them. These first openings 582 are spaced apart and extend axially along the deformable segment, and all have the same size.

[0665] In one embodiment, the elastic piece 521 extends from the connecting portion 581 toward the distal end and gradually converges to form a third section 583. The distal end of the elastic piece 521 has an arc structure. The elastic piece 521 extends from the connecting portion 581 toward the proximal end and gradually converges to form a fourth section 584. The fourth section has a greater convergence trend than the third section.

[0666] In one embodiment, a second gap 585 is provided between adjacent third sections 583 , and a third gap 586 is provided between adjacent fourth sections 584 . In an initial state, the second gap 585 and the third gap 586 form a V shape.

[0667] In one embodiment, the same elastic sheet 521 is provided with a second opening 587 for relieving stress during deformation. The second opening 587 extends axially along the deformation section, with both ends extending equidistantly to the third section 583 and the fourth section 584, respectively. The second opening 587 gradually converges axially toward its ends, forming a V-shaped structure.

[0668] The proximal end of the fourth section 584 is provided with a connector 588 for connecting to the main section. In the figure, the connector 588 is a T-shaped structure. Referring to the above embodiment, the proximal end of the fourth section 584 is connected to the main section, that is, the deformation section and the main section are integrally formed.

[0669] The ends of the second opening 587 axially overlap with the second gap 585 and the third gap 586, respectively, so that the third section 583 and the fourth section 584 each have two first deformation strips 591 and two second deformation strips 592 arranged in a V-shape. When expanding outward, the first deformation strips 591 and the second deformation strips 592 move away from each other in the circumferential direction.

[0670] In one embodiment, at least one elastic piece has a different length from the other elastic pieces, or the lengths of the elastic pieces are all different, wherein the length of the elastic piece is the length between the two ends along the axial direction, and the proximal ends of the elastic pieces are at the same axial position.

[0671] In a preferred embodiment, the elastic piece includes a first elastic piece and a second elastic piece adjacent to each other along the circumferential direction, wherein the length of the first elastic piece is greater than the length of the second elastic piece.

[0672] The present application also provides a delivery system, comprising 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 the catheter sheath 70 of the above-mentioned 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 existing technologies. 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, compared with a conventional catheter assembly, the outermost tube can be omitted.

[0673] The length of the catheter sheath of the present application can reach a 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.

[0674] 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.

[0675] 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 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; A locking element is located as a whole at the distal end of the base, and the locking element is rotationally matched with the base 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 control mechanism also 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.

3. The control mechanism of the artificial implant according to claim 1, characterized in that: 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; 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 interior of the base has a first cavity, the proximal 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; 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.

4. The control mechanism of the artificial implant according to claim 3, characterized in that: The locking area is located at the second opening portion.

5. The control mechanism of the artificial implant according to claim 4, characterized in that: A plurality of the second openings are arranged at intervals along the circumference of the base, and ribs are provided between adjacent second openings.

6. The control mechanism of the artificial implant according to claim 5, characterized in that: All the ribs converge and are fixed to each other at the distal end of the base.

7. The control mechanism of the artificial implant according to claim 6, characterized in that: All the ribs converge into a ring-shaped structure.

8. The control mechanism of the artificial implant according to claim 5, characterized in that: The opening direction of the lock hole is the circumferential direction of the base.

9. The control mechanism of the artificial implant according to claim 5, characterized in that: The locking hole is formed on at least one rib.

10. The control mechanism of the artificial implant according to claim 5, characterized in that: All ribs are provided with keyholes.

11. The control mechanism of the artificial implant according to claim 5, characterized in that: There are one or more key holes on the same rib.

12. The control mechanism of the artificial implant according to claim 5, characterized in that: The plurality of locking holes are arranged in sequence along the extending direction of the ribs.

13. The control mechanism of the artificial implant according to claim 3, characterized in that: There are multiple ribs with locking holes, and the positioning part as a whole has a relative end and a head end, and the head end is inserted into or separated from each locking hole in sequence as the locking piece rotates.

14. The control mechanism of the artificial implant according to claim 3, 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, and when the locking element is released from the engagement with the free end of the pull wire, the restriction on the artificial implant is released; In the first state, the free end extends out of the base through the corresponding second opening, passes through the artificial implant, and then returns to the locking area corresponding to the same second opening, or returns to the locking area corresponding to the adjacent second opening.

15. The control mechanism of the artificial implant according to claim 14, characterized in that: The free end of the pull wire is located in the current locking area in the first state, and the two ends of the positioning portion located in the current locking area are respectively inserted into the locking holes on the corresponding sides.

16. The control mechanism of the artificial implant according to claim 3, characterized in that: A plurality of locking areas are arranged at intervals along the circumference of the base, and the positioning portion enters or moves out of each locking area in sequence as the locking element moves.

17. The control mechanism of the artificial implant according to claim 1, characterized in that: 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; The positioning portion has a curved shape and extends circumferentially around the base, and the positioning portion is inserted into or separated from the locking hole as the locking element rotates.

18. The control mechanism of the artificial implant according to claim 17, characterized in that: The positioning portion includes at least one arc-shaped structure matched with the base.

19. The control mechanism of the artificial implant according to claim 17, characterized in that: The positioning portion is a spiral structure.

20. The control mechanism of the artificial implant according to claim 19, characterized in that: The helical structure is wound at least once.

21. The control mechanism of the artificial implant according to claim 19, characterized in that: The spiral structure is a multi-circle structure, and each circle is arranged along the axial direction of the base.

22. The control mechanism of the artificial implant according to claim 19, characterized in that: The extension path of the helical structure is a cylindrical helix or at least partly a conical helix.

23. The control mechanism of the artificial implant according to claim 19, characterized in that: 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.

24. The control mechanism of the artificial implant according to claim 23, characterized in that: The connecting portion is tubular, and the position where the end of the positioning portion is located is sleeved on the outer periphery of the connecting portion or abuts against the proximal end of the connecting portion.

25. The control mechanism of the artificial implant according to claim 24, characterized in that: 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.

26. The control mechanism of the artificial implant according to claim 17, 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, and when the locking element is released from the engagement with the free end of the pull wire, the restriction on the artificial implant is released; 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.

27. The control mechanism of the artificial implant according to claim 26, characterized in that: The positioning portion as a whole has a relatively opposite end and head end, wherein a connecting portion is fixed to the position where one end is located, and a positioning mechanism for maintaining the axial position of the connecting portion and the base is provided between the connecting portion and the base; The positioning 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 and abutting against the first end surface.

28. The control mechanism of the artificial implant according to claim 27, characterized in that: The connecting portion is in the shape of a tube extending in equal diameter or at least radially expands outward at its proximal end, and its proximal end is a connecting section. The distal end of the base has an extending section, and the connecting section and the extending section are nested with each other.

29. 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, and when the locking element is released from the engagement with the free end of the pull wire, the restriction on the artificial implant is released; 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.

30. The control mechanism of the artificial implant according to claim 29, characterized in that: 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.

31. The control mechanism of the artificial implant according to claim 1, characterized in that: 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; The free end has a ring. When the free end is in a first state, the positioning portion penetrates into the ring. When the free end is in a second state, the positioning portion extracts the ring.

32. The control mechanism of the artificial implant according to claim 31, characterized in that: The loop is independently configured or formed by winding the pull wire itself.

33. The control mechanism of the artificial implant according to claim 31, characterized in that: The positioning portion is in a spiral shape with multiple turns, and there is an axial gap between adjacent turns; in the first state, the pull wire extends out of the base through the current axial gap, and the free end after winding around the artificial implant is sleeved to a turn adjacent to the current axial gap.

34. The control mechanism of the artificial implant according to claim 31, characterized in that: 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.

35. The control mechanism of the artificial implant according to claim 1, characterized in that: The artificial implant has an axial direction in space, 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: In the retracted state, the wire control end is radially retracted close to the base; In the expanded state, the wire control end radially expands relatively away from the base; The round trip paths of the same pull wire passing through the artificial implant do not overlap.

36. The control mechanism of the artificial implant according to claim 35, characterized in that: The holes are multiple and isolated from each other. In the expanded state, the same pull wire passes through at least two holes.

37. The control mechanism of the artificial implant according to claim 35, characterized in that: The round trip path of the same pull wire through the artificial implant roughly forms a triangle.

38. The control mechanism of the artificial implant according to claim 35, characterized in that: The number of the holes is twice the number of the pull wires. In the expanded state, the same pull wire corresponds to two holes.

39. 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 being arranged outside the first shaft, the third shaft being provided with a locking assembly, the artificial implant being bound to the locking assembly by the pull wire when loaded, the locking assembly comprising a locking member and a base, the two having a mutually matched locking state and a mutually unmatched unlocking state, each state respectively restricting and allowing the pull wire to be separated from the artificial implant; The linkage assembly acts between the first shaft and the locking element to selectively link the two.

40. The locking mechanism according to claim 39, characterized in that: The locking element is integrally located at the distal end of the base, and the locking element is rotationally matched with the base to lock or release the free end of the pull wire.

41. The locking mechanism according to claim 40, 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 can move axially to make the two matching parts linked or disengaged.

42. The locking mechanism according to claim 41, characterized in that: 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.

43. The locking mechanism according to claim 42, characterized in that: There are multiple linkage keys, which are connected to each other through a tubular component, and the multiple linkage keys are arranged along the circumference of the tubular component.

44. The locking mechanism according to claim 43, characterized in that: There are multiple linkage grooves, which are connected to each other through a tubular component, and the multiple linkage grooves are arranged along the circumference of the tubular component.

45. The locking mechanism according to claim 42, characterized in that: At least a part of the locking element is a connecting portion, and the linkage key or linkage groove is arranged at the distal end of the connecting portion.

46. ​​The locking mechanism according to claim 45, characterized in that: The connecting portion is located outside the base.

47. The locking mechanism according to claim 45, characterized in that: The linkage groove is formed on the tube wall at the distal end of the connecting portion, and a linkage key is arranged on the inner peripheral wall of the loading section.

48. The locking mechanism according to claim 42, characterized in that: The notch of the linkage groove has a flared structure.

49. The locking mechanism according to claim 41, characterized in that: The two matching parts are a linkage key and a linkage groove that can be separated by relative rotation, and the linkage key is linked to each other along the axial direction when inserted into the linkage groove.

50. The locking mechanism according to claim 39, characterized in that: A support member is disposed on the inner periphery of the loading section, and the support member is fixed to the distal end of the first shaft, wherein a matching portion is disposed on the support member.

51. The locking mechanism according to claim 50, characterized in that: A limiting structure is provided between the support member and the loading section to limit the axial separation of the two.

52. The locking mechanism according to claim 51, characterized in that: The limiting structure comprises a positioning piece radially protruding from the outer periphery of the supporting member, and a positioning groove arranged on the inner peripheral surface of the loading section and cooperating with the positioning piece.

53. The locking mechanism according to claim 52, characterized in that: The support member is a cylindrical structure, and a portion of the outer periphery is turned outward to form the positioning piece.

54. The locking mechanism according to claim 53, characterized in that: The supporting member includes an outer cylinder connected to the loading section, and an inner cylinder with a matching portion fixed to the first shaft.

55. The locking mechanism according to claim 54, characterized in that: The inner cylinder and the outer cylinder are separate structures.

56. An interventional delivery system for an artificial implant, characterized in that: include: A catheter sheath, used for constructing an intervention channel, wherein the proximal end of the catheter sheath is provided with a fixing seat; A bending adjustment component, the distal end of which can be controlled to change direction, and the bending adjustment component slides through the fixing seat and further extends toward the proximal end; An inner shaft assembly, the distal end of which is provided with a loading section for connecting an artificial implant, the loading section being always exposed to the distal end of the bending adjustment assembly; A control handle is connected to the bending adjustment assembly and the proximal end of the inner shaft assembly. The control handle is located on the proximal side of the fixing seat and the distance between the control handle and the fixing seat is adjustable.

57. The interventional delivery system according to claim 56, characterized in that: The inner shaft assembly comprises a first shaft, a second shaft and a third shaft which are sequentially slidably sleeved from the inside to the outside, wherein: The distal end of the first shaft is linked with a locking element; A pull wire is connected to the distal end of the second shaft; A base is fixed at the distal end of the third shaft, the locking element is movably mounted on the base, and a locking hole matching the locking element is provided on the base; The pull wire is bound to the base by the locking element after winding around the artificial implant from the second axis, and the second axis and the first axis are slidably matched relative to the third axis.

58. The interventional delivery system according to claim 57, characterized in that: The locking element is integrally located at the distal end of the base, and the locking element is rotationally matched with the base to lock or release the free end of the pull wire.

59. A control method for making an artificial implant detach from an interventional delivery system, characterized in that: include: Provided are an artificial implant and an interventional delivery system for delivering the artificial implant, wherein the artificial implant comprises an inner frame defining a blood flow channel, the outer periphery of the inner frame is provided with a plurality of arms, a first gap for accommodating native tissue is formed between each arm and the inner frame, a valve leaf for controlling the blood flow channel is connected to the inner frame, the distal end of the inner frame is maintained in a compressed state by a tubular loading section, and the proximal end of the inner frame is maintained in a compressed state by being bound by a pull line; First, expanding at least a portion of the arm to align the first gap with the native tissue; Driving the loading section distally to separate from the inner frame, so that the distal end of the inner frame expands; The part of the pull wire that exposes the locking element is stretched, so that the proximal end of the inner frame is expanded, so that the inner frame is deformed to a desired extent as a whole, and the control of the inner frame by the pull wire is always maintained; Moving the loading section proximally so that at least a portion of the loading section is transferred to the proximal side of the leaflet via the blood flow channel; The connection between the pull wire and the inner frame is released.

60. A control method for recovering an artificial implant using an interventional delivery system, characterized in that: include: An artificial implant and an interventional delivery system for delivering the artificial implant are provided, wherein the interventional delivery system comprises: A catheter sheath, used for constructing an intervention channel, wherein the proximal end of the catheter sheath is provided with a fixing seat; 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; A control handle connected to the proximal end of the inner shaft assembly, the control handle being located on the proximal side of the fixing seat, and a push mechanism that can interact with the fixing seat being provided at the distal end of the control handle; The artificial implant at least partially remains connected to the inner shaft assembly. When being 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.

61. The control method according to claim 60, characterized in that: The distal end of the catheter sheath approaches or contacts the artificial implant, driving the pushing mechanism to abut against the fixing seat, and further pushing toward the distal end until the artificial implant is received in the catheter sheath.

62. The control method according to claim 60, characterized in that: The artificial implant is connected to the inner shaft assembly via a pull wire. When the artificial implant is recovered, the pull wire is kept in a tightened state to gather the proximal side of the artificial implant.

63. The control method according to claim 60, characterized in that: Before the recovery is performed, the shape of the artificial implant is in an expanded state and is connected to the inner shaft assembly only by a pull wire. Before the recovery is performed, the pull wire is first tightened to gather the proximal side of the artificial implant.

64. The control method according to claim 60, characterized in that: The artificial implant comprises an inner frame defining a blood flow channel, the outer periphery of the inner frame is provided with a plurality of arms, the proximal ends of the arms are fixed to the inner frame, a first gap capable of accommodating native tissue is formed between the distal ends of the arms and the inner frame, and a valve leaf for controlling the blood flow channel is connected to the inner frame; During the retrieval, the proximal end of the arm first enters the catheter sheath, and the distal end of the arm adaptably enters the catheter sheath as the catheter sheath moves relative to the artificial implant.

65. A method for loading an artificial implant into a delivery system, characterized in that: include: An artificial implant and a delivery system are provided, wherein the artificial implant comprises an inner frame, and a plurality of arms are provided on the outer periphery of the inner frame; The delivery system comprises: a catheter sheath with a fixing seat at the proximal end; An inner shaft assembly, movably arranged in the catheter sheath, wherein the distal end of the inner shaft assembly is provided with a loading section; a control handle connected to the proximal end of the inner shaft assembly; Passing a pull wire around the proximal end of the inner frame; The conveying system also includes a control mechanism, which includes a base connected to the inner shaft assembly, a locking member movably cooperated with the base, and a plurality of pull wires, one end of the pull wire is connected to the control handle, and the other end is passed through the inner frame and locked to the base and the locking member, and the plurality of pull wires are locked one by one.

66. The loading method according to claim 65, characterized in that: During the locking process, the locking element moves relative to the base in a rotational manner.

67. The loading method according to claim 66, characterized in that: During the locking process, the pull wire is tightened to radially compress the proximal end of the inner frame.

68. The loading method according to claim 67, characterized in that: The plurality of pull wires are tightened synchronously.

69. The loading method according to claim 66, characterized in that: The distal end of the inner frame is accommodated in the loading section, specifically, the catheter sheath moves toward the distal end to accommodate the arm portion and the proximal end of the inner frame.

70. The loading method according to claim 69, characterized in that: The distal end of the inner frame and at least the distal end portion of the arm are stored in the loading section.

71. The loading method according to claim 70, characterized in that: The catheter sheath moves distally to accommodate the proximal end of the inner frame and the exposed portion of the arm.

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