Delivery system for artificial implant

Abstract

Provided is a delivery system for an artificial implant, comprising a control handle (400) and a catheter assembly (200) connected proximally to the control handle. The catheter assembly (200) comprises an outer sheath (240) and an inner shaft assembly located within the outer sheath (240), the artificial implant (100) being connected to the distal end of the inner shaft assembly and controlled by the control handle (400). The control handle (400) comprises a first handle (41) and a second handle (42) operatively cooperating with each other, the first handle (41) being configured to drive axial movement of the outer sheath (240) to achieve deployment and folding of the artificial implant, and the second handle (42) being configured to control release of the artificial implant to achieve detachment of the artificial implant from the delivery system.

Description

Delivery systems for artificial implants Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a delivery system for artificial implants. Background Art

[0002] Percutaneous artificial heart valve replacement and repair is an advanced heart valve interventional treatment technology that can repair or replace heart valves through intervention without the need for open-chest surgery.

[0003] Percutaneous implantation techniques offer less invasive options than surgical procedures such as open-heart surgery. In percutaneous implantation, a loaded implant or prosthetic valve is mounted on the distal end of a flexible catheter and advanced through the patient's blood vessels or through a puncture in the patient's skin until the prosthetic valve reaches the implantation site. The prosthetic valve at the distal end of the catheter expands to its functional size at the site of the diseased native valve.

[0004] During interventional valve implantation surgery, the following problems often occur:

[0005] First, when the self-expanding artificial valve reaches the implantation site in the human body, the operator retracts the delivery sheath to complete the release of the artificial valve. At this time, the artificial valve tends to "jump" out from the end of the sheath very quickly; in other words, the outward biasing force of the artificial valve frame tends to cause the artificial valve to pop out from the distal end of the delivery sheath very quickly, making it difficult to deliver the artificial valve from the sheath in a precise and controlled manner and increasing the risk of trauma to the patient.

[0006] Secondly, in existing artificial valve products, the valve is usually gripped and recovered by advancing the sheath when the valve is expanded to 2 / 3; when the valve is fully expanded, that is, completely detached from the sheath, it is usually difficult to recover the artificial valve. Summary of the Invention

[0007] The present application provides a delivery system that can still achieve the recovery of an artificial implant when the artificial implant is fully deployed / expanded.

[0008] The present application provides a delivery system for an artificial implant, having relative distal and proximal ends, the delivery system including a control handle and a catheter assembly whose proximal end is connected to the control handle, the control handle including a first handle and a second handle that cooperate with each other; the catheter assembly including an outer sheath and an inner shaft assembly located within the outer sheath, the artificial implant being connected to the distal end of the inner shaft assembly and being controlled by the control handle, the first handle being used to drive the axial movement of the outer sheath to achieve the expansion and folding of the artificial implant; the second handle being used to control the release of the artificial implant to achieve the detachment of the artificial implant from the delivery system.

[0009] When the artificial implant is fully expanded / expanded (i.e., implanted form), the artificial implant has already broken away from the constraints of the outer sheath. The present invention uses the second handle to control the further compression of the artificial implant in the fully expanded state, for example, by compressing or folding the proximal end of the artificial implant and then pushing the outer sheath toward the distal end to retract the artificial implant. Through the cooperation of the first handle and the second handle, the artificial implant can be quickly retracted into the catheter system.

[0010] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0011] Optionally, each handle includes a support member and a driving mechanism provided on the support member;

[0012] The support structure in the first handle includes a first support body and a support rod fixed to the first support body and further extending in the proximal direction. The support structure in the second handle includes a second support body slidably mounted on the support rod. A sliding locking mechanism is also provided on the distal side of the second support body itself. The sliding locking mechanism acts with the support rod to maintain the relative position with the first support body.

[0013] Optionally, the catheter assembly includes an outer sheath and at least one shaft from outside to inside, specifically:

[0014] an outer sheath, the proximal end of which is movably connected to the first base in the first handle, and the distal end of which is used to cover the artificial implant;

[0015] a third shaft having a proximal end fixed to the second handle;

[0016] a second shaft, a proximal end movably connected to a second base in the second handle;

[0017] The first shaft has a proximal end movably connected to the proximal end of the second handle.

[0018] Optionally, a first extension sleeve is further fixed to the distal end of the first support body, and the catheter assembly further comprises:

[0019] A sheath is located outside the outer sheath, and a proximal end of the sheath is fixed to the first extension sleeve.

[0020] Optionally, a first support is fixed in the first extension sleeve, the proximal end of the sheath is fixed to the first support, the outer sheath seal passes through the first support, and the first support is provided with a first exhaust structure.

[0021] Optionally, a second support is fixed to the distal end of the second support body, the proximal end of the third shaft is fixed to the second support, the second shaft seal passes through the second support, and a second exhaust structure is provided on the second handle.

[0022] Optionally, the first exhaust structure and the second exhaust structure are one-way valves.

[0023] Optionally, a second extension sleeve is further fixed to the proximal end of the second support body, and the driving mechanism includes:

[0024] a first driving mechanism, disposed on the first support body and linked to the outer sheath;

[0025] a second driving mechanism, disposed on the second support body and linked to the second shaft;

[0026] A third driving mechanism is disposed on the second extension sleeve and is linked to the first shaft.

[0027] Optionally, the third driving mechanism includes a third base slidably mounted in the second extension sleeve, and a third driving sleeve threadedly engaged with the third base and rotatably mounted on the second extension sleeve.

[0028] Optionally, the second extension sleeve is provided with a third support, the second exhaust structure is provided on the third support, and an exhaust pipe penetrating the second support body is provided between the third support and the second support.

[0029] Optionally, the distal end portion of the second support body includes an axially arranged partition, the partition is provided with a through hole for the exhaust pipe to pass through, and the second support body is provided with a groove serving as the channel.

[0030] Optionally, the distal end of the third shaft is connected to a lock seat, and the lock seat has a lock hole or a groove;

[0031] The distal end of the second shaft is connected to a locking wire, which is used to pass through the artificial implant and then connect to the locking seat to restrain or release the artificial implant;

[0032] The distal end of the first shaft is connected to a locking rod or a protruding structure is arranged along the circumference, which is used to keep the locking wire connected to the lock seat.

[0033] Optionally, one end of the locking wire is a driving end and is connected to the second shaft, and the other end of the locking wire is a working end, which is passed through the artificial implant and then tightened or loosened on the locking seat.

[0034] Optionally, the lock line has a developing mark.

[0035] Optionally, the distal end of the lock line has a developing mark.

[0036] Optionally, the developing mark is connected to the lock thread through bonding, sewing, weaving, riveting and other processes.

[0037] The control handle includes a rotating component sleeved on the support body, the rotating component is a cylindrical structure and has an inner wall and an outer wall opposite to each other, and the rotation locking mechanism includes:

[0038] a first pipe member fixed to the support body, wherein the control handle has a mounting passage extending axially through the support body, and a portion of the mounting passage extends through the interior of the first pipe member;

[0039] a second pipe member, rotatably sleeved on the outer periphery of the first pipe member, wherein a portion of the second pipe member is a working section extending into the rotating component, and an outer wall of the working section has a protrusion;

[0040] a locking member located in a radial gap between the working section and the rotating member and configured to slide radially along the rotating member and act on the inner wall of the rotating member, wherein during the rotation of the second pipe, the locking member is pressed against the locking member by the protrusion and acts on the corresponding locking rotating member;

[0041] The operating component drives the second pipe to rotate.

[0042] Optionally, the side walls of the support body and the first pipe are partially opened toward the same radial side to form a mounting opening.

[0043] Optionally, the side wall of the second pipe is open toward one radial side, and the opening position is staggered with the opening position of the first pipe in the circumferential direction.

[0044] Optionally, the support body includes:

[0045] The main body is cylindrical and extends axially along the control handle, and the first tube is located at the proximal end side of the main body;

[0046] The connecting seat is fixed to the proximal end of the main body and has a radial gap between it and the first pipe member. The radial position of the second pipe member is located in the radial gap.

[0047] Optionally, the connecting seat as a whole is a shell structure with a semi-cylindrical surface, and the support body also includes a half shell that is fastened and fixed to the connecting seat and enclosed in a cylindrical shape, and the half shell is provided with an avoidance window, and the operating component is exposed in the avoidance window.

[0048] Optionally, the connecting seat is provided with a radially penetrating guide groove, the locking member includes a first locking member slidably disposed in the guide groove, and the protrusion on the second tube member abuts against the radial inner side of the first locking member.

[0049] Optionally, a groove wall of the guide groove is provided with a registration structure that cooperates with the first locking member.

[0050] Optionally, the locking member includes:

[0051] A first locking member is slidably embedded in the connecting seat;

[0052] The second locking piece is movably buckled with the connecting seat in the radial direction, and the first locking piece and the second locking piece move synchronously in opposite directions.

[0053] Optionally, the second locking member is semi-annular and is provided with a guiding structure that cooperates with the supporting body.

[0054] Optionally, the connecting seat has a blocking portion that abuts against the operating component to limit its rotation range.

[0055] Optionally, the first locking member and the second locking member are in the same axial position and are located on two opposite sides of the second tube in the radial direction.

[0056] Optionally, the locking element includes a plurality of locking elements arranged along the axial direction.

[0057] Optionally, a stopper is embedded at the position where the locking member cooperates with the rotating member.

[0058] Optionally, the first locking member and the second locking member are made of hard material, and the stop member is made of soft material.

[0059] Optionally, the rotating component is a driving sleeve, and the driving sleeve is rotatably sleeved on the outer periphery of the support body.

[0060] Optionally, the height of the outer surface of the protrusion gradually increases along the circumference of the second pipe.

[0061] Optionally, the second pipe has relative:

[0062] In the locked position, the protrusion abuts against the locking member and acts on the rotating member;

[0063] A release position, wherein the protrusion and the locking member release the pressing force;

[0064] The locking member has an arc surface or a radial undulating structure that matches the protrusion.

[0065] Optionally, there are two support rods arranged side by side and with positioning teeth arranged on opposite sides;

[0066] The second support body is provided with a guide hole, and the two support rods extend into the corresponding guide holes. The sliding locking mechanism cooperates with the positioning teeth to maintain the relative position of the second handle relative to the first support body.

[0067] Optionally, the two support rods are slidably engaged with the guide holes.

[0068] Optionally, the support rod is a metal bar, the cross section of the metal bar is strip-shaped and the extending direction is perpendicular to the spacing arrangement direction of the two support rods.

[0069] Optionally, the sliding locking mechanism includes:

[0070] a lock element movably mounted on the second support body, having a locking position engaged with the positioning teeth and an unlocking position disengaged from the positioning teeth;

[0071] an elastic member acting between the locking member and the second support body to drive the locking member toward a locking position;

[0072] The operating button acts on the locking element to drive the locking element toward the unlocking position.

[0073] Optionally, the locking element has an assembly hole and is slidably mounted on the support rod through the assembly hole. There is a movable gap between the assembly hole and the support rod in a direction perpendicular to the sliding direction of the support rod, and the locking element moves along the movable gap during the process of switching positions.

[0074] Optionally, one side of the assembly hole faces the positioning tooth, and an engaging portion that matches the positioning tooth is provided on this side.

[0075] Optionally, the engaging portion is one or more latching teeth arranged at intervals along the sliding direction of the lock.

[0076] Optionally, the sliding locking mechanism is configured with two sets, each acting on a corresponding support rod, and the operating buttons in the two sets are aligned with each other radially along the second handle and arranged in opposite directions.

[0077] Optionally, abutting ribs are fixed in the second support body, and the elastic member is compressed between the abutting ribs and the locking member.

[0078] Optionally, the abutment ribs in the two sets of sliding locking mechanisms are arranged at intervals, and the interval area is for the installation channel to extend through.

[0079] Optionally, the locking member is provided with an alignment seat on a side facing the elastic member, and the elastic member is inserted into or sleeved on the alignment seat.

[0080] Optionally, the elastic member is a spring.

[0081] Optionally, the distal end of the second support body is a second connecting seat, comprising two partitions and a transition portion connected between the two partitions;

[0082] The transition portion as a whole is a shell structure with a semi-cylindrical surface, and the second support body also includes a second half shell that is fastened and fixed to the transition portion and enclosed in a cylindrical shape. The sliding locking mechanism is located in the area enclosed by the transition portion and the second half shell, and only a portion of the operating button is exposed.

[0083] Optionally, the second support body further includes a clamping seat engaged between the second connecting seat and the second half shell, and the clamping seat has an open slot for exposing the operating button.

[0084] Optionally, the open slot is circumferentially closed and extends along the movement direction of the operating button.

[0085] Optionally, there are two struts, and two connecting sleeves are fixed to the proximal end of the first support body, and the distal ends of the two struts are fixedly inserted into corresponding connecting sleeves;

[0086] The distal end of the second support body includes two partitions arranged at intervals along the axial direction, each partition is provided with a guide hole, and the second support body is provided with a third slide groove extending along the axial direction on two radially opposite sides. Each support rod passes through the corresponding guide hole and is placed in the corresponding third slide groove. The second handle as a whole slides relative to the first handle along the two support rods.

[0087] Optionally, the second handle has two extreme positions relative to the first handle along the two support rods, that is, a first extreme position in which the second handle is close to the first handle and a second extreme position in which the second handle is away from the first handle.

[0088] Optionally, the control handle includes a mounting channel axially penetrating the first support body and the second support body, and the first support body includes:

[0089] The first body is cylindrical and extends axially along the control handle;

[0090] The first connecting seat is fixed to the proximal end of the first main body, and the two connecting sleeves are fixed to the first connecting seat and are located on both sides of the installation channel in a radial direction.

[0091] Optionally, the side wall of the connecting sleeve and the distal end of the support rod are provided with corresponding positioning holes, and are fixedly connected by a connecting piece passing through the positioning holes.

[0092] Optionally, the first connecting seat as a whole is a shell structure with a semi-cylindrical surface, and the first supporting body further includes a first half shell that is fastened and fixed to the first connecting seat and forms a cylindrical shape.

[0093] Optionally, the connecting sleeve is located at the junction of the first connecting seat and the first half shell, and the outer wall of the connecting sleeve is provided with a buckle that matches the first half shell.

[0094] Optionally, a partial area of ​​the first body is radially penetrated to form a first guide groove, and the driving mechanism includes:

[0095] a first base, slidably disposed in the first guide groove, the first base being used to connect to a controlled component;

[0096] The first driving sleeve is a rotating sleeve arranged on the outer periphery of the first supporting body, and the inner wall of the first driving sleeve is threadedly matched with the first base.

[0097] Optionally, the control handle includes a mounting channel axially extending through the first support body and the second support body, and the second support body includes:

[0098] The second body is cylindrical and extends axially along the control handle, and the third sliding groove is located on a side of the second body facing away from the mounting channel;

[0099] a second connecting seat, comprising the two partitions and a transition portion connected between the two partitions, wherein one partition is fixed to the distal end of the second body;

[0100] The third connecting seat is fixed to the proximal end of the second body.

[0101] Optionally, the two partitions include a first partition at the distal end and a second partition at the proximal end, and a cover plate is fastened to the distal side of the first partition, and the cover plate is provided with an avoidance area corresponding to the position of the installation channel and the guide hole.

[0102] Optionally, a positioning rib extending in the radial direction is provided on the distal end side of the first partition, and a positioning groove cooperating with the positioning rib is provided on the cover plate.

[0103] Optionally, the two partitions extend from their respective mounting channel positions along the first radial opening to their own edges;

[0104] The cover plate is opened along a second radial direction opposite to the first radial direction at the position of the installation channel and extends to its own edge to form the positioning groove.

[0105] Optionally, the proximal end portion of the third sliding groove is an end section extending to the outer periphery of the third connecting seat, and a mutually cooperating snap-fit ​​structure is provided between the groove wall of the end section and the support rod.

[0106] Optionally, the snap-fit ​​structure includes:

[0107] a clamping block protruding from the groove wall of the third chute;

[0108] A card slot is provided on the support rod and cooperates with the card block.

[0109] Optionally, when the second handle slides and abuts against the first handle, the card block fits into the card slot.

[0110] Optionally, an anti-slip component is provided at the proximal end of the support rod, and when the second handle slides proximally relative to the first handle to an extreme position of the component, the anti-slip component is blocked by the partition.

[0111] Optionally, a partial area of ​​the second body is radially penetrated to form a second guide groove, and the driving mechanism includes:

[0112] a second base, slidably disposed in the second guide groove, the second base being used to connect to a controlled component;

[0113] The second driving sleeve is rotatably mounted on the outer periphery of the second supporting body, and the inner wall of the second driving sleeve is threadedly engaged with the second base.

[0114] Optionally, the transition portion as a whole is a shell structure with a semi-cylindrical surface, and the second support body further includes a second half shell that is fastened and fixed to the transition portion and forms a cylindrical shape.

[0115] Optionally, the artificial implant includes:

[0116] The stent is cylindrical and has a grid structure, and the interior of the stent is a blood flow channel;

[0117] Multiple leaflets, each leaflet is located in a blood flow channel and cooperates with each other to control blood flow interruption, and the edge of the leaflet includes a fixed edge connected to the bracket and a free edge that cooperates with other leaflets to control the blood flow channel.

[0118] Optionally, the artificial implant further includes an inner covering located in the blood flow channel and connected to the inner side of the stent, and a plurality of anti-leakage components connected to the inner covering, wherein the anti-leakage components are embedded in and protrude outward from the grid structure at corresponding positions.

[0119] The present application also provides a delivery system for an artificial implant, having opposite distal and proximal ends, the delivery system comprising a control handle and a catheter assembly whose proximal end is connected to the control handle, the artificial implant being connected to the distal end of the catheter assembly and being controlled by the control handle, the control handle comprising a support member and a drive mechanism disposed on the support member;

[0120] The support body is provided with a guide groove extending axially, and the driving mechanism includes a base moving along the guide groove and a driving sleeve rotatably installed on the outer periphery of the corresponding support body. The driving sleeve and the base are threadedly transmitted, and the support body is provided with a rotation locking mechanism on the proximal side of its own guide groove, which can limit or allow the rotation of the driving sleeve.

[0121] The present invention also discloses a control handle having relative distal and proximal ends, the control handle comprising a first handle and a second handle that cooperate with each other; each handle comprises a support member and a driving mechanism arranged on the support member; the support member in the first handle comprises a first support body and a support rod fixed to the first support body and further extending in the proximal direction; the support member in the second handle comprises a second support body slidably mounted on the support rod; a sliding locking mechanism is also provided on the distal side of the second support body itself, the sliding locking mechanism interacts with the support rod to maintain the relative position with the first support body.

[0122] The present invention also discloses a delivery system for an artificial implant, having relative distal and proximal ends, the delivery system including a control handle and a catheter assembly whose proximal end is connected to the control handle, the control handle including a first handle and a second handle that cooperate with each other; the catheter assembly includes an outer sheath and an inner shaft assembly located within the outer sheath, the artificial implant is connected to the distal end of the inner shaft assembly and is controlled by the control handle, the first handle is used to drive the axial movement of the outer sheath to achieve the expansion and folding of the artificial implant; the second handle is used to control the release of the artificial implant to achieve the detachment of the artificial implant from the delivery system.

[0123] Optionally, the artificial implant is connected to the distal end of the delivery system catheter assembly via a wire.

[0124] Optionally, a wire-controlled mechanism is provided at the distal end of the catheter assembly, and the wire-controlled mechanism includes a locking seat, a locking wire, and a protruding structure matching the locking seat structure.

[0125] Optionally, a wire-controlled mechanism is provided at the distal end of the second handle or the catheter assembly, and the wire-controlled mechanism includes a clamping and / or releasing mechanism for the lock wire.

[0126] Optionally, the second handle has a first state in which it slides away from the first handle, and a second state in which it is connected to the first handle. An axially extending strut is provided between the first and second handles, and one of the first and second handles is provided with the strut, while the other is provided with a guide hole, such that when the second handle moves relative to the first handle, the strut moves axially relative to the guide hole.

[0127] Optionally, a first locking mechanism is further provided on the distal end side of the second support body, and the first locking mechanism interacts with the strut to maintain a relative position with the first support body.

[0128] Optionally, the support structure in the first handle includes a first support body and a support rod fixed to the first support body and further extending in the proximal direction, and the support structure in the second handle includes a second support body slidably mounted on the support rod, and a first locking mechanism is also provided on the distal side of the second support body itself, and the first locking mechanism acts with the support rod to maintain the relative position with the first support body.

[0129] Optionally, a second locking mechanism for controlling the movement of the first handle and / or the second handle is provided in the first handle and / or the second handle.

[0130] The present invention also provides a delivery system for an artificial implant, having relative distal and proximal ends, the delivery system including a control handle and a catheter assembly whose proximal end is connected to the control handle, the artificial implant is connected to the distal end of the catheter assembly and is controlled by the control handle, the control handle including a first handle and a second handle that cooperate with each other, each handle including a support member and a driving mechanism arranged on the support member; the support member in the first handle includes a first support body and a strut fixed to the first support body and further extending in the proximal direction, the support member in the second handle includes a second support body slidably mounted on the strut; each support body is provided with a guide groove extending axially, the driving mechanism includes a base that moves along the guide groove and a driving sleeve rotatably mounted on the outer periphery of the corresponding support body, and a threaded transmission is provided between the driving sleeve and the base; each support body is respectively provided with a rotation locking mechanism on the proximal side of its own guide groove that can limit or allow the rotation of the driving sleeve.

[0131] Optionally, a sliding locking mechanism is further provided on the distal end side of the second support body, and the sliding locking mechanism interacts with the strut to maintain a relative position with the first support body.

[0132] The present invention also discloses a delivery system for an artificial implant, having relative distal and proximal ends, the delivery system including a control handle and a catheter assembly whose proximal end is connected to the control handle, the control handle including a first handle and a second handle that cooperate with each other; the catheter assembly includes an outer sheath and an inner shaft assembly located within the outer sheath, the artificial implant is connected to the distal end of the inner shaft assembly and is controlled by the control handle, the first handle is used to drive the axial movement of the outer sheath to achieve the expansion and folding of the artificial implant; a bending adjustment piece is provided in the inner shaft assembly, and a bending adjustment drive mechanism for driving the movement of the bending adjustment piece is provided in the second handle.

[0133] The present invention also discloses a wire-controlled mechanism for an artificial implant, having relative distal and proximal ends, the wire-controlled mechanism comprising: a locking seat, comprising a guide portion, a reduced diameter portion and a connecting portion arranged in sequence, wherein the connecting portion is respectively provided with a locking hole and a wire hole, the guide portion is provided with a guide hole corresponding to the position of the locking hole, the outer periphery of the reduced diameter portion is a radially open coupling area, the distal end shape of the connecting portion converges and forms an expansion area connected to the coupling area on the outer periphery; a locking rod, which slides with the locking seat and is inserted into the locking hole through the guide hole; a locking wire, one end of which is a driving end and extends to the proximal end through the wire hole, and the other end is a working end used to pass through the artificial implant and then be coupled to the locking rod.

[0134] In the delivery system of the present application, the support rod in the delivery system handle serves as a connecting member between the second handle and the first handle, improving the structural strength of the control handle, and cooperating with the sliding locking mechanism to maintain the length of the control handle and meet operational requirements, such as increasing the speed of recovering the artificial implant, and after the artificial implant is successfully released, the distal structure can be quickly retracted. BRIEF DESCRIPTION OF THE DRAWINGS

[0135] FIG1 is a structural view of a conveying system according to an embodiment of the present application;

[0136] FIG2 is a structural view of the control handle in FIG1 ;

[0137] FIG3 is a schematic diagram of the structure of the second handle in the control handle of FIG1 sliding toward the proximal end relative to the first handle;

[0138] FIG4 is a cross-sectional view of the control handle in FIG2 along its own axial direction;

[0139] FIG5 is an exploded view of the second handle in the control handle of the present application;

[0140] Figure 6 is an enlarged view of part A in Figure 1;

[0141] FIG7 is a partial structural view of the locking rod and the locking seat in the wire control mechanism according to an embodiment of the present application;

[0142] FIG8 is a cross-sectional view of a catheter assembly according to an embodiment of the present application;

[0143] FIG9 is a schematic diagram of a state in which the distal end of the delivery system according to an embodiment of the present application releases the artificial implant and loosens the locking wire;

[0144] FIG10 is a schematic diagram of a state in which the distal end of the delivery system according to an embodiment of the present application releases the artificial implant and the locking wire;

[0145] FIG11 is a structural view of a second support body in a control handle according to an embodiment of the present application;

[0146] FIG12 is an exploded view of a control handle between a support rod and a first handle according to an embodiment of the present application;

[0147] FIG13 is an exploded view of a sliding locking mechanism in a control handle according to an embodiment of the present application;

[0148] FIG14 is an enlarged view of portion B in FIG4 (the sliding locking mechanism is in a locked state);

[0149] FIG15 is an enlarged view of portion B in FIG4 (the sliding locking mechanism is in the unlocked state);

[0150] FIG16 is a structural view of a locking member in a control handle according to an embodiment of the present application;

[0151] FIG17 is a schematic diagram of the assembly between the locking member and the support rod in the control handle according to one embodiment of the present application;

[0152] FIG18 is a structural view of an operating button in a control handle according to an embodiment of the present application;

[0153] FIG19 is an exploded view of the second half shell and the second drive sleeve in the control handle according to one embodiment of the present application;

[0154] FIG20 is an exploded view of an operating button in a control handle according to an embodiment of the present application;

[0155] FIG21 is a structural view of a card holder in a control handle according to an embodiment of the present application;

[0156] FIG22 is an exploded view of the control handle between the rotating component and the support body in FIG2 ;

[0157] FIG23 is an exploded view of the locking member and half shell in FIG22;

[0158] FIG24 is a structural view of the support body in FIG23;

[0159] FIG25 is a front view of the second pipe according to an embodiment of the present application

[0160] FIG26 is a structural view of the second pipe member in FIG25;

[0161] FIG27 is a structural view of the second pipe member in FIG26 from another perspective;

[0162] FIG28 is a front view of a control handle according to an embodiment of the present application;

[0163] FIG29 is a cross-sectional view taken along the FF direction in FIG28 (the locking device is in an unlocked state);

[0164] FIG30 is a cross-sectional view taken along the FF direction in FIG28 (the locking device is in a locked state);

[0165] FIG31 is a structural view of a locking member (first locking member) according to an embodiment of the present application;

[0166] FIG32 is an exploded view of the area between the first locking member and the support body in FIG31 ;

[0167] FIG33 is an enlarged view of portion C in FIG22;

[0168] FIG34 is an exploded view of the area between the second locking member and the support body in FIG33 ;

[0169] FIG35 is an enlarged view of portion D in FIG24;

[0170] FIG36 is a cross-sectional view taken along the EE direction in FIG28 (the locking device is in the unlocked state);

[0171] FIG37 is a cross-sectional view taken along the EE direction in FIG28 (the locking device is in a locked state);

[0172] FIG38 is a partial structural view of a control handle according to an embodiment of the present application when the second handle is in a second extreme position;

[0173] FIG39 is a structural view of the first half shell of the control handle according to an embodiment of the present application;

[0174] FIG40 is a structural view showing the engagement structure between the support rod and the slide groove in the control handle according to one embodiment of the present application;

[0175] FIG41 is a partial structural view of the proximal end portion of the second support body in FIG11;

[0176] FIG42 is an enlarged view of section G in FIG38;

[0177] FIG43 is a partial structural view of the support rod and the anti-drop member in FIG12;

[0178] FIG44 is a structural view of an artificial implant according to an embodiment of the present application;

[0179] FIG45 is a partial view of the anti-circular leakage component in FIG44;

[0180] Figure 46 is a schematic structural diagram of the lock seat in this application;

[0181] Figure 47 is a schematic diagram of the lock seat in this application;

[0182] FIG48 is a schematic diagram of the E direction viewing angle in FIG47;

[0183] FIG49 is a schematic cross-sectional view of the lock seat GG in FIG48;

[0184] FIG50 is a schematic diagram showing the connection between an artificial implant and a control wire according to an embodiment of the present application;

[0185] FIG51 is a schematic diagram of the second end of the control line in FIG50 being separated from the lock seat;

[0186] Figure 52 is an enlarged view of portion H in Figure 50;

[0187] FIG53 is an enlarged view of the movement path of the retaining member avoidance and release structure in FIG52.

[0188] Figure 54 is a structural diagram of the anti-slip structure.

[0189] The reference numerals in the figures are as follows: 100, artificial implant; 110, stent; 111, mesh structure; 112, inflow side; 120, leaflet; 130, anti-leakage component; 140, inner covering; 150, blood flow channel; 200, catheter assembly; 210, inner core; 220, wire control tube; 230, inner sheath; 240, outer sheath; 250, sheath; 31, locking seat; 311, guide portion; 32, locking rod; 312, reduced diameter portion; 313, connecting portion; 314, wire hole; 315, locking hole; 316, guide hole; 317, coupling area; 318, expansion area; 33, locking wire; 331, imaging mark; 34, control wire; 341, first end; 342, second end; 343, anti-slip structure; 35, locking seat; 351, coupling groove; 400, control handle; 401, proximal end; 402, distal end; 403, mounting channel; 404, first indicator window; 405, second indicator window; 41, first handle; 410, first support body; 4101, second slide groove; 4102, first guide groove; 411, first body; 412, first connecting seat; 4121, guide groove; 4122, positioning groove; 4123, first slide groove; 4124, blocking portion; 414, first half shell; 415, buckle; 416, limiting rib; 418, first extension sleeve; 4181, avoidance window; 419, first support; 4191, first exhaust structure; 42, second handle; 420, second support body; 4201, abutting rib; 4202, spacer area; 4203, clamping plate; 4204, mounting area; 421. Second body; 4211. Third slide; 422. Second connecting seat; 4212. Second guide groove; 4213. Groove; 4221. Partition; 4221a. First partition; 4221b. Second partition; 4222. Guide hole; 4223. Transition portion; 4225. Positioning rib; 4226. Avoidance hole; 423. Third connecting seat; 4231. Clamping block; 424. Cover plate; 4241. Avoidance area; 4242. Positioning groove; 425. Second half shell; 426. Clamping seat; 4261. Open slot; 427. Second extension sleeve; 428. Second support; 429. Third support; 4291. Second exhaust structure; 430, sliding locking mechanism; 431, locking member; 4311, assembly hole; 4312, movable gap; 4313, meshing portion; 4314, locking hole; 4315, alignment seat; 432, elastic member; 433, operating button; 4331, locking column; 440, connecting sleeve; 441, positioning hole; 442, connecting member; 450, support rod; 4501, locking groove; 4502, positioning tooth; 451, anti-slip member; 4511, nut; 4512, screw; 452, support bar; 453, rack; 4521, mounting slot; 460, rotation locking mechanism; 461, first pipe fitting; 4611, mounting opening; 462, second pipe fitting;4621, working section; 4622, raised portion; 4623, opening; 463, locking member; 4631, first locking member; 4632, positioning block; 4633, first slider; 4635, second locking member; 4637, avoidance zone; 4638, arc surface; 4639, second slider; 464, operating member; 4641, anti-slip portion; 4642, identification mark; 4643, stopper; 470, exhaust pipe; 480, rotating member; 481, first drive sleeve; 482, second drive sleeve; 483, third drive sleeve; 491, first base; 492, second base; 493, third base. DETAILED DESCRIPTION

[0190] 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.

[0191] 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.

[0192] 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.

[0193] 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.

[0194] 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 for performing interventional surgery. The catheter assembly includes multiple controlled components, and the distal ends of each controlled component cooperate with each other to operate the artificial implant, such as releasing, retrieving, locking position, adjusting bending, adjusting spatial posture, etc. Each controlled component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of multiple forms. There are multiple controlled components, and at least two of them (taking the proximal end as an example) can slide relative to each other along the axial direction or rotate relative to each other around the axial direction.

[0195] The artificial implant can be an artificial heart valve or a vascular stent. An artificial heart valve includes a stent and leaflets connected to the stent to control blood flow interruption. The leaflets may be multiple, typically two or three. If needed, skirts may be added to the inside and / or outside of the stent, such as the anti-peripheral leakage component described below. The stent itself can be braided or cut from tubing. Artificial heart valves can be used to replace diseased heart valves, such as the aortic valve.

[0196] In the following text, when used to indicate direction, the proximal end generally refers to the side adjacent to the operator (such as a doctor), and the distal end refers to the relatively farther side. Along the interventional path, each component has a relative distal and proximal end. In theory, when the catheter assembly and the control handle are fully straightened, the straight line between the proximal and distal ends determines the axial direction, and correspondingly, the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction are also determined. When used to refer to a structure, the "end" in the text indicates the end point of the structure or a point or area on that side or a specific structure connected to that point or area.

[0197] The present application provides a delivery system for an artificial implant, having relative distal and proximal ends. The delivery system includes a control handle and a catheter assembly 200 whose proximal end is connected to the control handle 400. The control handle 400 includes a first handle 41 and a second handle 42 that cooperate with each other; the catheter assembly 200 includes an outer sheath 240 and an inner shaft assembly located within the outer sheath 240. The artificial implant 100 is connected to the distal end of the inner shaft assembly and is controlled by the control handle 400. The first handle 41 is used to drive the axial movement of the outer sheath 240 to achieve the expansion and folding of the artificial implant 100; the second handle 42 is used to control the release of the artificial implant 100 to achieve the separation of the artificial implant 100 from the delivery system.

[0198] The artificial implant in the present application may be an artificial heart valve, an occluder or an intracardiac repair device, such as a mitral or tricuspid valve clip for heart valve repair.

[0199] Among them, the outer sheath 220 moves axially relative to the artificial implant 100. During interventional delivery, the outer sheath 220 wraps the artificial implant 100, and can radially restrain the artificial implant 100 to limit its radial expansion. After the outer sheath 220 moves to expose part or all of the artificial implant 100, the exposed part is expanded and needs to be recovered. The outer sheath 220 moves in the opposite direction to re-wrap the artificial implant 100, that is, drive the artificial implant 100 to radially collapse and fold.

[0200] The axial movement of the outer sheath 220 relative to the artificial implant 100 determines whether the artificial implant 100 is exposed, but does not strictly limit the immediate radial expansion of the exposed portion. However, it at least releases the radial constraint and allows the artificial implant 100 to expand radially.

[0201] The artificial implant 100 is connected to the inner shaft assembly and restricts the axial relative position of each other. After the artificial implant 100 is in place in the body, the connection with the inner shaft assembly needs to be released so that the delivery system and the artificial implant 100 can be separated and withdrawn to the body. The inner shaft assembly can also control the timing and process of the deployment of the artificial implant 100. These can be achieved using the second handle 42, that is, the second handle 42 is connected to the inner shaft assembly to control the release of the artificial implant 100. The release includes the deployment, releasing the inner shaft assembly from the artificial implant, and the recovery of the artificial implant.

[0202] Referring to Figures 1 to 9, the present application provides a delivery system for an artificial implant, having a relative distal end 402 and a proximal end 401, the delivery system includes a control handle 400 and a catheter assembly 200 whose proximal end is connected to the control handle 400, and the artificial implant 100 is connected to the distal end of the catheter assembly 200 and is controlled by the control handle 400. The control handle 400 includes a first handle 41 and a second handle 42 that cooperate with each other, and each handle includes a support member and a driving mechanism arranged on the support member. The driving mechanism is a plurality of groups, each group is connected to a part of the catheter assembly, and is used to control the wire control mechanism located at the distal end of the catheter assembly to complete the expansion, release and recovery of the artificial implant, or to achieve actions such as bending the catheter. The support member is used to provide a basis for the installation and movement of the driving mechanism and / or another handle and the structural support of the corresponding handle.

[0203] The support structure in the first handle 41 includes a first support body 410 and two struts 450 fixedly connected to the first support body 410 and extending proximally. The support structure in the second handle 42 includes a second support body 420 slidably mounted on the struts 450. Each support body is provided with an axially extending guide groove. The drive mechanism includes a base that slides along the axial direction of the control handle and a drive sleeve rotatably mounted on the periphery of the corresponding support body. The drive sleeve and the base are threaded together. Some components of the catheter assembly are connected to the base and are driven by the drive sleeve to complete corresponding operations.

[0204] Each support body is provided with a rotation locking mechanism (referred to as a second locking mechanism) on the proximal side of its own guide groove, which can limit or allow the rotation of the drive sleeve. Of course, based on the same principle, the rotation locking mechanism can also be provided on the distal side of the guide groove.

[0205] A sliding locking mechanism, also referred to as a first locking mechanism, is provided at the distal end of the second support body 420 itself. This sliding locking mechanism interacts with the strut 450 to maintain its relative position to the first support body 410. The "sliding" in the "sliding locking mechanism" refers to the sliding movement of the second handle 42 relative to the first handle 41. The "rotating" in the "rotating locking mechanism" refers to the rotational movement of the drive sleeve relative to the corresponding support body.

[0206] The catheter assembly 200 radially includes, from the outside to the inside, an outer sheath 240 and an inner shaft assembly located within the outer sheath 240. The inner shaft assembly includes at least one shaft, wherein an shaft refers to one or more shafts fixed to each other. For example, two relatively fixed pipes can also be considered as one shaft. As shown in Figure 8, the catheter assembly 200 specifically includes the outer sheath 240, a third shaft (such as the inner sheath 230 described below), a second shaft (such as the wire control tube 220 described below), and a first shaft (such as the inner core 210 described below). The first shaft 210, the second shaft 220, and the third shaft 230 belong to the inner shaft assembly. Among them, the distal end of the inner core 210 is provided with a guide head.

[0207] Referring to Figures 4 to 10, the proximal end of the outer sheath 240 is movably connected to the first base 491 in the first handle 41, and the distal end is used to enclose the artificial implant 100. The proximal end of the third shaft is fixed to the second handle 42, the proximal end of the second shaft is movably connected to the second base 492 in the second handle 42, and the proximal end of the first shaft is movably connected to the proximal end of the second handle 42. The inner shaft assembly, namely the first shaft, the second shaft, and the third shaft are all controlled by the second handle 42. When the sliding locking mechanism is unlocked, the second handle 42 can be relatively moved away from or closer to the first handle 41, thereby simultaneously driving the first shaft, the second shaft, and the third shaft to move rapidly relative to the outer sheath 240, achieving closure between the proximal end of the guide head and the distal end of the outer sheath.

[0208] In one embodiment, a first extension sleeve 418 is further fixed to the distal end of the first support body 410 , and the catheter assembly 200 further includes a sheath 250 which is sleeved on the outside of the outer sheath 240 and fixed to the first handle 41 at its proximal end.

[0209] In one embodiment, the artificial implant is released and retrieved via a wire control mechanism. As shown in Figures 6, 7, 9, and 10, the distal end of the inner sheath 230 is connected to a locking seat 31. One end of the inner core 210 is an extension extending from the distal end of the inner sheath 230. A locking rod 32 is fixed to the extension and is located distal to the locking seat 31. The distal end of the wire control tube 220 is connected to a locking wire 33. The locking wire 33 is passed around the artificial implant 100 and then tightened or loosened on the locking seat 31 to restrain or release the artificial implant 100. The locking seat 31, locking wire 33, and locking rod 32 constitute the wire control mechanism.

[0210] When the artificial implant 100 is loaded, the locking wire 33 extends from the distal end of the inner sheath 230, wraps around the artificial implant 100, and is then bound to the locking rod 32. The locking rod 32 engages with the locking seat 31 to prevent the locking wire 33 from being released. The proximal end of the locking wire 33 is connected to the control handle via a second shaft. In addition to being a wire-controlled tube 220, the second shaft can also be a wire. There can be multiple wires, each corresponding to the locking wire 33, for example, the locking wire 33 and the second shaft are integrally structured. In this embodiment and the accompanying drawings, the second shaft uses a wire-controlled tube as an example.

[0211] The relative motion of inner core 210 and inner sheath 230 can realize the relative motion of lock seat 31 and locking rod 32, thereby changing the constraint state of locking wire 33.The state of locking wire 33 can affect the motion process of artificial implant 100, especially in the release process of artificial implant 100, realize the staged release of artificial implant 100 by locking wire 33, further, the mutual motion of each pipe fitting can provide structural basis for the full release and full recovery return of artificial implant 100, thereby provide more controllable interventional treatment process, improve patient experience while promoting treatment effect.When releasing the artificial implant 100 (fully expanded but still connected with locking wire 33) after expansion and needing to be recovered, unlock aforementioned sliding locking mechanism, then the second handle 42 slides relative to the first handle 41 and can realize the rapid withdrawal of artificial implant 100 and is received in its interior by outer sheath 240.

[0212] In one embodiment, the locking base is provided with one or more grooves along its circumference, and the extended end is provided with protrusions along its circumference that match the number and structure of the locking base's grooves. The locking wire is threaded around the artificial implant and is tightened by the locking base's grooves and protrusions. The wire control mechanism includes the locking base, the locking wire, and the protrusions that match the locking base structure.

[0213] Referring to one embodiment, the lock base 31 is provided with a lock hole that cooperates with the lock rod 32. In the locked state, the lock rod 32 is inserted into the lock hole and restricts the range of movement of the lock wire 33. Referring to one embodiment, the lock rod 32 moves with the inner core 210 and has the following positions:

[0214] In the locked position (see FIG9 ), the locking rod 32 is inserted into the lock hole to constrain the lock wire 33 ;

[0215] In the release position (see FIG. 10 ), the locking rod 32 is disengaged from the locking hole to release the locking wire 33 .

[0216] In one embodiment, the catheter assembly 200 further includes a wire control tube 220 that is movably mounted on the outer portion of the inner core 210. One end of the locking wire 33 is a driving end connected to the wire control tube 220, and the other end of the locking wire is a working end. When the artificial implant is loaded, the working end is wound around the artificial implant 100 and engages with the locking rod 32. There may be multiple locking wires 33.

[0217] As shown in Figure 10, in one embodiment, the locking wire 33 is provided with a visual marker 331. This marker 331 is located at the distal end of the locking wire 33 and is made of a visually sensitive metal such as a platinum-iridium alloy or gold. This facilitates intraoperative visualization of the positional relationship between the locking wire 33, the artificial implant 100, the locking seat 31, and the locking rod 32, thereby enabling precise release and retrieval. The visual marker 331 is connected to the locking wire 33 via bonding, sewing, braiding, riveting, or other processes. The visual marker 331 may be solid or hollow and, depending on the connection process, may have various shapes, such as annular, filamentous, circular, or square.

[0218] During interventional surgery and in vitro simulation tests, for example, during interventional delivery, the rotary locking mechanism is in a locked state, and the outer sheath 240 wraps the artificial implant 100 and the wire control mechanism until it is delivered to the surgical site, thereby improving the safety of interventional delivery. When the artificial implant is aligned and released, the rotary locking mechanism is unlocked, and the first handle 41 is operated to move the outer sheath 240 relative to other catheter components to control the release of the artificial implant; after the artificial implant is successfully released, the sliding locking mechanism is unlocked, and the second handle slides proximally relative to the first handle, quickly retracting the inner shaft assembly into the outer sheath so that the guide head is precisely connected to the distal end of the outer sheath and then withdrawn from the body. This can improve operational efficiency and reduce safety hazards during overall withdrawal.

[0219] As shown in FIG4 , the control of the catheter assembly and the corresponding drive mechanism is as follows:

[0220] The first support body 410 is provided with a first guide groove 4102, and the second support body 420 is provided with a second guide groove 4212. A first extension sleeve 418 is fixed to the distal end of the first support body 410, and a first support 419 is fixed in the first extension sleeve 418. A first base 491 is slidably installed in the first guide groove 4102 of the first support body 410, and a first drive sleeve 481 is rotatably sleeved on the outside of the first support body 410 and threadedly engaged with the first base 491; a second extension sleeve 427 is fixed to the proximal end of the second support body 420, and a second support 428 is fixed to the distal end of the second support body 420. A second base 492 and a third base 493 are slidably installed in the second guide groove of the second support body 420, and the second support body 420 is rotatably sleeved with a second drive sleeve 482 and a third drive sleeve 483 which are threadedly engaged with the second base 492 and the third base 493 respectively.

[0221] The sheath 250 is fixed to the first support 419 in the first extension sleeve 418, the outer sheath 240 is fixedly connected to the first base 491, the inner sheath 230 is fixedly connected to the second support 428, the wire control tube 220 is sealed and passes through the second support 428 and is fixedly connected to the second base 492, and the inner core 210 is fixedly connected to the third base 493.

[0222] In one embodiment, an exhaust structure (such as a one-way valve) is provided on the control handle 400. Specifically, the first support 419 is provided with a first exhaust structure 4191, and the second handle 42 is provided with a second exhaust structure 4291. In the figure, a third support 429 is provided on the second extension sleeve 427, and the second exhaust structure 4291 is provided on the third support 429. The third support 429 is connected to the second support 428 through an exhaust pipe 470, and the exhaust pipe 470 passes through the second support body 420.

[0223] Specifically, the first exhaust structure is used to exhaust the gas between the sheath and the outer sheath tube, and the second exhaust structure is used to exhaust the gas between the outer sheath tube and the inner sheath tube, the inner sheath tube and the control line tube, and the control line tube and the inner core.

[0224] During surgery, the surgeon typically uses an image to view the release or retraction status of the implant. However, imaging systems typically have poor visibility. To allow the surgeon to more intuitively understand the implant's deployment or folding status during surgery, a control handle is provided with a display window that displays the implant's deployment or folding status. For example, in one embodiment, as shown in FIG1 , the control handle is provided with a first display window 404. The first display window 404 can be embedded with a transparent cover for easy viewing and protection. The first display window 404 or its surrounding area displays an image or text indicating the implant's status, such as the fully deployed state and the folded state. Furthermore, the first display window can include a marker at the distal end indicating the stent's fully deployed state and a marker at the proximal end indicating the stent's retracted state, to indicate the progress of the procedure. The first display window 404 includes a movable marker, such as a pointer, that can be used to determine the implant's deployment or folding status by observing its position. The marker can be connected to a second base, with the axial movement of the second base driving the marker's movement.

[0225] As shown in Figure 2, the control handle may also be provided with a second indicator window 405 for displaying whether the locking rod 32 has disengaged from the locking line, thereby indicating whether the prosthetic heart valve has finally been released from the catheter assembly. The second indicator window 405, or its surrounding area, displays an image or text indicating whether the locking rod has disengaged from the locking line. Furthermore, the second indicator window 405 may include a movable indicator, such as a pointer, which indicates whether the locking rod has disengaged from the locking line by observing its position. The indicator may be connected to the third base 492, and its movement is driven by the axial movement of the third base.

[0226] As shown in FIG4, FIG5 and FIG11, the second support body 420 includes:

[0227] The second main body 421 is cylindrical and extends axially. The second support body 420 is provided with third chute 4211 extending axially on two radially opposite sides. Each support rod 450 passes through the corresponding guide hole 4222 and is placed in the corresponding third chute 4211.

[0228] The second connecting seat 422 includes two partitions 4221 and a transition portion 4223 connected between the two partitions 4221, wherein one partition 4221 is fixed to the distal end of the second body 421;

[0229] The third connecting seat 423 is fixed to the proximal end of the second body 421 .

[0230] The third slide groove 4211 is provided on the back of the second body 421, facilitating observation of the assembly of the strut 450. Furthermore, given the strip-shaped strut 450, this reduces the space occupied by the second body 421, ensuring the structural strength of the second body 421. The second support 428 is mounted within the second connecting base 422. The second body 421 is provided with a groove 4213 that serves as a passageway. A partition at the proximal end (i.e., the second partition 4221b described below) is provided with a relief hole 4226. The exhaust pipe 470, after connecting to the duct assembly, extends from the second support 428, passes through the open side of the transition portion 4223, and then through the relief hole 4226 and groove 4213 until it connects to the third support 429. The groove 4213 is provided on the outer wall of the second guide slot 4212.

[0231] Referring to Figure 13 , in one embodiment, the two partitions 4221 include a first partition 4221a at the distal end and a second partition 4221b at the proximal end. A cover plate 424 is fastened to the distal end of the first partition 4221a. The cover plate 424 defines an escape area 4241 corresponding to the positions of the mounting channel 403 and the guide hole 4222. The transition portion 4223 between the two partitions 4221 is generally a shell structure having a semi-cylindrical surface. The second support body 420 further includes a second half shell 425 fastened to the transition portion 4223 to form a cylindrical shape. The cover plate 424 is fastened to the first partition 4221a and the second half shell 425.

[0232] The distal end of the first partition plate 4221a is provided with radially extending positioning ribs 4225, and the cover plate 424 is provided with positioning grooves 4242 that mate with the positioning ribs 4225. The two partition plates 4221 extend from their respective mounting channel locations along a first radial direction X to their respective edges. The cover plate 424 extends from its mounting channel location along a second radial direction Y, opposite to the first radial direction X, to its own edge, forming positioning grooves 4242.

[0233] Referring to Figures 3 and 11-21, in one embodiment, two struts 450 are arranged side by side with a limiter positioned on each side facing the other. A sliding locking mechanism cooperates with the limiter to maintain the relative position of the second handle relative to the first support body. Once the two limiters are released, the second handle is allowed to slide relative to the first support body. The limiter, for example, is the positioning tooth 4502 provided in this embodiment. The support member in the second handle 42 includes a second support body 420, which defines a guide hole 4222. The two struts 450 extend into the corresponding guide holes 4222. The second handle 42 is also provided with a sliding locking mechanism 430 that cooperates with the positioning tooth 4502 to limit the relative position of the first handle 41 and the second handle 42. As shown in Figure 15, in the unlocked state, the sliding locking mechanism 430 allows the second handle 42 to slide along the strut 450 relative to the first handle 41. In the locked state, as shown in Figure 14, the second handle 42 is fixed relative to the first handle 41.

[0234] The support rod serves as a connecting member between the second handle and the first handle, and is also provided with positioning teeth for cooperating with the sliding locking mechanism to control the position of the second handle relative to the first handle, thereby meeting the operation of the control handle and simplifying the structure of the control handle.

[0235] The sliding locking mechanism 430 includes a locking member 431, an elastic member 432, and an operating button 433. The locking member 431 is movably mounted on the second support body 420 and has a locked position in which it engages with the positioning teeth 4502 and an unlocked position in which it disengages from the positioning teeth 4502. The elastic member 432 (e.g., a spring) acts between the locking member 431 and the second support body 420, driving the locking member 431 toward the locked position. The operating button 433 acts on the locking member 431, driving the locking member 431 toward the unlocked position. The unlocking and locking operations are as follows: applying force to the operating button 433 compresses the elastic member 432, driving the locking member 431 to the unlocked position; releasing the operating button 433 causes the elastic member 432 to return to its original position and act on the locking member 431, causing it to switch back to the locked position.

[0236] In one embodiment, the locking member 431 and the operating button 433 slide radially. The locking member 431 has an assembly hole 4311 . The assembly hole 4311 is formed by a groove in the interior of the locking member 431 .

[0237] The assembly hole 4311 is slidably mounted on the support rod 450. A movable gap 4312 is provided between the assembly hole 4311 and the support rod 450 in the direction perpendicular to the sliding direction of the support rod 450 (i.e., the sliding direction of the lock member 431). The lock member 431 moves along the movable gap 4312 during the process of switching between the unlocked and locked positions. Specifically, the movable gap 4312 is configured such that the size of the assembly hole 4311 in the radial sliding direction of the lock member 431 is greater than the thickness of the support rod 450. With reference to Figures 13 to 17 , during assembly, the lock member 431 is mounted on the support rod 450, which restricts the lock member 431 from falling out of the second support body 420. By utilizing different installation directions and the interaction between the various components, the additional limiting structure is eliminated, the component structure is simplified, and assembly is facilitated.

[0238] In one embodiment, one side of the assembly hole 4311 faces the positioning tooth 4502, and an engaging portion 4313 is provided on this side to mate with the positioning tooth 4502. The engaging portion 4313 is a tooth structure that mates with the positioning tooth 4502. In conjunction with the movement direction of the locking element 431, the locking element 431 moves radially outward toward the locked position and radially inward toward the unlocked position. The engaging portion 4313 is disposed on the bottom side of the assembly hole 4311 (this side faces radially outward). The positioning tooth 4502 has a trapezoidal cross-section.

[0239] In one embodiment, the number of positioning teeth 4502 is combined with the operation of the control handle as follows:

[0240] There is one positioning tooth 4502, which is used to keep the second handle at the farthest position relative to the first handle to achieve closure between the proximal end of the guide head and the distal end of the outer sheath (i.e., the second extreme position described below);

[0241] There are multiple positioning teeth 4502 arranged at intervals along the axial direction, which can define a second handle at multiple positions for adjusting the position of the artificial implant in the body, or adjusting the covering distance of the outer sheath to the artificial implant when retrieving the artificial implant.

[0242] The sliding locking mechanism 430 comprises two sets, each acting on a corresponding support rod 450. The operating buttons 433 in the two sets are arranged radially opposite and in opposite directions along the second handle 42. An abutment rib 4201 is fixed within the second support body 420, and an elastic member 432 is compressed between the abutment rib 4201 and the locking member 431.

[0243] The control handle 400 has a mounting channel 403 that axially passes through the first support body 410. The abutment ribs 4201 in the two sets of sliding locking mechanisms are arranged at intervals and form corresponding spacing areas 4202. As shown in Figure 11, the spacing areas 4202 allow the mounting channel 403 to extend through.

[0244] In one embodiment, the locking element 431 is provided with an alignment seat 4315 on the side facing the elastic element 432, into which the elastic element 432 is inserted or sleeved. In the figure, the elastic element 432 is a spring, and the alignment seat 4315 has a cavity for accommodating the spring portion. After assembly, the elastic element 432 and the locking element 431 are restrained by the support rod 450 and prevented from falling out of the second support body 420. Two axially spaced retaining plates 4203 protrude from the abutting rib 4201. Between the two retaining plates 4203, a mounting area 4204 is formed that mates with the alignment seat 4315, restricts axial movement of the locking element 431, and serves as a guide for the movement of the locking element 431.

[0245] In one embodiment, the support rod 450 is a metal bar. The radial cross section of the metal bar along the control handle is strip-shaped and substantially rectangular, and the extension direction (length direction) on the cross section is perpendicular to the spacing direction of the two support rods 450 .

[0246] In one embodiment, the support bar 450 includes a support bar 452 and a rack 453 with positioning teeth 4502, as shown in Figure 12. The support bar 452 defines a mounting slot 4521 for mounting the rack 453. The rack 453 and the support bar 452 can be connected by embedding or fixed connection (e.g., bonding or welding). The mounting slot 4521 is open toward the bottom and extends across the sliding travel of the second handle 42 relative to the first handle 41.

[0247] In one embodiment, the relationship between the positioning teeth 4502 and the bottom side of the support bar 452 is as follows:

[0248] The positioning teeth 4502 protrude from the bottom side of the support bar 452;

[0249] or the positioning teeth 4502 are flush with the bottom side of the support bar 452;

[0250] Or the positioning teeth 4502 are lower than the bottom side of the support bar 452 .

[0251] In one embodiment, the distal end of the second support body 420 is a second connecting seat 422 , which includes two partitions 4221 and a transition portion 4223 connected between the two partitions 4221 ;

[0252] The transition portion 4223 is a shell structure with a semi-cylindrical surface as a whole. The second support body 420 also includes a second half shell 425 that is fastened and fixed to the transition portion 4223 and enclosed in a cylindrical shape. The sliding locking mechanism 430 is located in the area enclosed by the transition portion 4223 and the second half shell 425, and only a portion of the operating button 433 is exposed for operation by the operator.

[0253] Referring to Figures 16 and 18 , in one embodiment, the operating button 433 and the locking member 431 are engaged and fixed, with a latching post provided on one of the two and a latching hole provided on the other that mates with the latching post. For example, in the illustration, the latching post 4331 protrudes from the operating button 433; the latching hole 4314 is provided in the locking member 431 and tightly mates with the latching post 4331. There are two latching posts 4331.

[0254] Referring to Figures 20 and 21, in one embodiment, the second support body 420 also includes a socket 426 that is engaged between the second connecting socket 422 and the second half shell 425. The socket 426 has an open groove 4261 for exposing the operating button 433. The socket 426 surrounds the circumference of the operating button 433 and fills the gap between the operating button 433 and the second support body 420 and the second half shell 425.

[0255] The open groove 4261 is circumferentially closed, and the wall of the open groove extends along the movement direction of the operating button 433 to provide a movement guide for the operating button 433 .

[0256] Referring to Figures 2 and 23-38, the rotation locking mechanism 460 includes a first tube 461, a second tube 462, and a locking member 463. It should be noted that the first tube 461 and the second tube 462 are not part of the catheter assembly 200. The first tube 461 is fixed to the support body, for example, by being separately connected and fixed inside the handle, or by being integrally formed with the support body as part of the support body. The figure uses the first support body 410 as an example, and the first tube 461 is formed as part of the first support body 410. A portion of the mounting channel 403 extends through the interior of the first tube 461, meaning that the first tube 461 is a hollow structure through which part or all of the catheter assembly 200 can pass.

[0257] The second tubular member 462 is rotatably mounted on the outer periphery of the first tubular member 461. A portion of the second tubular member 462 forms a working section 4621 that extends into the rotating component 480. The outer wall of the working section 4621 has a raised portion 4622. Both the first tubular member 461 and the second tubular member 462 extend axially along the control handle. They are not strictly limited to being circumferentially closed and can also be partially circumferentially open. Furthermore, there are no strict restrictions on their cross-sectional shapes.

[0258] The locking member 463 is located in the radial gap between the working section 4621 and the rotating member 480 and is configured to move radially along the rotating member 480 and act on the inner wall of the rotating member 480. During the rotation of the second tube 462, the protrusion 4622 presses against the locking member 463 to move it and lock the rotating member 480 accordingly, or the protrusion 4622 releases the pressure on the locking member 463 to unlock the rotating member 480. The protrusion 4622 protrudes in at least the radial direction.

[0259] As shown in Figure 29, when in the unlocked position, the locking member 463 and the inner wall of the rotating member 480 have a movable gap, thereby allowing the rotating member 480 to be easily rotated under human influence; as shown in Figure 30, when the second tube 462 rotates around the dotted line to the locked position, the locking member 463 moves in the direction of the arrow to resist the rotating member 480, so that a sufficiently large force (such as static friction) is generated between the two, thereby limiting the rotation of the rotating member 480. This device structure can lock the rotating member 480 to any position, which is beneficial for controlling the artificial implant. Compared with the existing locking structure, it improves the operating accuracy of the control handle, and the locking operation is completed in one step, simplifying the operating steps. In addition, the locking member is installed in the radial gap between the working section and the rotating member, which makes the appearance of the control handle simple, the overall shape and structure are easy to hold and operate, and the space is effectively utilized, making the structure of the control handle more compact.

[0260] In this embodiment, the rotation locking mechanism 460 further includes an operating component 464, which is used to drive the second pipe 462 to rotate. The operating component 464 is movably disposed on the first support body 410 and can be used with the second pipe 462 as follows:

[0261] a. Split connection;

[0262] b. Integrally formed, for example, the second pipe 462 and the operating component 464 are integrally formed, one section of the second pipe 462 along the axial direction is the working section 4621, and the other section is connected to the operating component 464;

[0263] c. They are independent of each other and are linked and coordinated with each other through transmission parts.

[0264] The second pipe 462 has relative:

[0265] In the locked position, the protrusion 4622 abuts against the locking member 463 and acts on the rotating member 480 to generate a tightening force thereon;

[0266] In the release position, the protrusion 4622 and the locking member 463 release the pressing force.

[0267] As shown in Figures 22 to 24, in one embodiment, the side walls of the first support body 410 and the first pipe 461 are partially opened toward the same radial side to form an installation opening 4611, which is connected to the installation channel 403 to facilitate the installation of the catheter assembly 200 and the base.

[0268] In one embodiment, the sidewall of the second tube member 462 is open radially to one side, and the open position is circumferentially offset from the open position of the first tube member 461. This open side of the second tube member 462 allows its working section 4621 to have a certain degree of radial deformation capability. For example, when locked, the inner wall of the working section 4621 abuts against the outer wall of the first tube member 461, and the working section 4621 is subjected to forces in both radially inward and outward directions, thereby limiting the rotation of the second tube member 462. When unlocking, a greater driving force is required to be applied to the operating component, thereby preventing accidental unlocking and improving safety.

[0269] Among them, the circumferential staggered distribution of the open position of the second tube fitting 462 and the open position of the first tube fitting 461 is understood as: taking the unlocking position of Figure 29 as an example, when the second tube fitting 462 rotates, the open port 4623 of the second tube fitting 462 does not coincide with the installation port 4611.

[0270] Referring again to Figures 23 to 27, in one embodiment, the first support body 410 includes a first main body 411 and a first connecting seat 412. The first main body 411 is cylindrical and extends axially along the control handle. The first tubular member 461 is located proximal to the first main body 411. The first connecting seat 412 is fixed to the proximal end of the first main body 411 and has a radial gap with the first tubular member 461. The second tubular member 462 is radially located within the radial gap. The first connecting seat 412 is generally a shell structure having a semi-cylindrical surface. The first support body 410 also includes a first half shell 414 that is fastened to the first connecting seat 412 and forms a cylindrical shape. The first half shell 414 defines a relief window 4181, through which the operating member 464 is exposed. The operating member 464 is provided with an anti-slip portion 4641 and an indicator 4642 for indicating locking and unlocking.

[0271] The settings of the locking parts are as follows:

[0272] As shown in Figures 31 and 32, in one embodiment, the first connecting seat 412 defines a radially extending guide groove 4121. The locking member includes a first locking member 4631 (e.g., a block-shaped member) radially slidably disposed within the guide groove 4121. The protrusion 4622 on the second tubular member 462 abuts against the radially inner side of the first locking member 4631. The working section 4621 of the second tubular member 462 has a circular outer contour. The protrusion 4622 extends in the direction of rotation for locking (hereinafter referred to as the first direction). The outer surface height of the protrusion 4622 gradually increases along the first direction. The inner wall of the locking member is a curved surface that matches the outer contour of the protrusion 4622.

[0273] Based on the mutually coordinated shape structure of the locking member 463 and the protrusion 4622, the groove wall of the guide groove 4121 is provided with a registration structure that cooperates with the first locking member 4631. The registration structure prevents the first locking member 4631 from being installed incorrectly and locates the position of the first locking member 4631 relative to the guide groove 4121. The registration structure includes:

[0274] The positioning groove 4122 is provided on the groove wall of the guide groove 4121 or the first locking member 4631;

[0275] The positioning block 4632 is disposed on the groove wall of the guide groove 4121 or the other of the first locking member 4631 and cooperates with the positioning groove 4122. The positioning groove 4122 is a flared structure.

[0276] As shown in Figures 30, 33 and 34, in another embodiment, the locking member 463 can be multiple along the circumferential direction, for example, including a first locking member 4631 and a second locking member 4635, the second locking member 4635 is movably engaged with the first connecting seat 412 along the radial direction, and the first locking member 4631 and the second locking member 4635 move synchronously in opposite directions, respectively acting on different radial inner walls of the same rotating component 480, thereby improving the locking strength.

[0277] The second locking member 4635 is semi-annular and has a matching guide structure disposed between the second locking member 4635 and the first supporting body 410 .

[0278] As shown in Figure 30, the guide structure includes:

[0279] The first slider 4633 is disposed on one of the first connecting seat 412 or the second locking member 4635;

[0280] The first sliding groove 4123 is disposed in the other one of the first connecting seat 412 and the second locking member 4635 and cooperates with the first sliding block 4633 .

[0281] As shown in FIG33 and FIG34 , in another embodiment, the guide structure further includes:

[0282] The second sliding groove 4101 is provided on the first body 411;

[0283] The second sliding block 4639 is disposed on the second locking member 4635 and cooperates with the second sliding groove 4101 .

[0284] 29 and 30 , in one embodiment, the first locking member 4631 and the second locking member 4635 are located at the same axial position and on opposite radial sides of the second tube 462. In another embodiment, the locking member 463 includes multiple locking members arranged axially, for example, multiple locking members acting on different axial positions of the same rotating component.

[0285] A stopper 4643 is embedded in the position where the locking member 463 mates with the rotating member 480. In conjunction with the foregoing, both the first locking member 4631 and the second locking member 4635 are embedded with the stopper 4643, as shown in Figure 23. The first and second locking members 4631 and 4635 are made of a hard material and can slide stably after mating with the first connecting seat 412. The stopper 4643 is made of a soft material with a high coefficient of friction and a certain degree of deformation, such as rubber. When locked, the stopper 4643 compresses against the inner wall of the rotating member 480, thereby increasing static friction.

[0286] As for the second locking member 4635, it is installed in the gap between the first connecting seat 412 and the first half shell 414, and the second locking member 4635 can move in the radial direction through the aforementioned guide structure, at least it can always maintain a gap between the second locking member 4635 and the inner wall of the rotating component 480, so that when in the unlocked position, the rotating component 480 can rotate smoothly.

[0287] The inner wall of the second locking member 4635 has a radially undulating structure, comprising an arcuate surface 4638 (centered about the axis of the control handle) and a relief area 4637 that, when in the unlocked position, is radially recessed to clear the protrusion 4622. As shown in Figure 29, in the unlocked position, the radially raised portion of the protrusion 4622 is located within the relief area 4637. In the locked position, as shown in Figure 30, this portion abuts against the arcuate surface 4638, forcing the second locking member 4635 to slide radially outward.

[0288] As shown in Figures 35 to 37, in one embodiment, the first connecting seat 412 has a blocking portion 4124 that abuts against the operating component 464 to limit its rotation range. In the figure, there are two blocking portions 4124 and they are sheet-like structures. The operating component 464 abuts against one of the blocking portions 4124 in the locked position and the unlocked position respectively.

[0289] In one embodiment, a partial area of ​​the first support body 410 is radially penetrated to form a first guide groove 4102, and a base (for example, a first base 491) is slidably arranged in the first guide groove 4102, and the base is used to connect the controlled component (for example, the catheter assembly 200); the rotating component 480 is a driving sleeve, and the driving sleeve is rotatably sleeved on the outer periphery of the first support body 410, and the inner wall of the driving sleeve and the base are threadedly matched, so the aforementioned stop member 4643 can better adapt to the threaded structure of the driving sleeve.

[0290] Regarding the rotation locking mechanism, the rotation locking mechanism is independent of the number of handles. For example, the control handle 400 includes one handle, and the rotation locking mechanism is provided on the handle.

[0291] In one embodiment, the proximal end of the first support body 410 is fixedly connected to two connecting sleeves 440, and the distal end of each support rod 450 is fixedly inserted into the corresponding connecting sleeve 440. The two can be fixed by a snap connection or connected by fasteners.

[0292] The supporting structure of the second handle 42 includes a second support body 420, and the distal end of the second support body 420 includes two partitions 4221 arranged along the axial direction, and each partition 4221 is provided with a guide hole 4222. The second support body 420 is provided with a third slide groove 4211 extending along the axial direction on two radially opposite sides. Each support rod 450 passes through the corresponding guide hole 4222 and is placed in the corresponding third slide groove 4211. The second handle 42 as a whole slides relative to the first handle 41 along the two support rods 450, and has two extreme positions close to / away from the first handle 41, namely the first extreme position of the second handle 42 abutting against the first handle 41 as shown in Figure 2, and the second extreme position of the second handle 42 away from the first handle 41 as shown in Figure 3.

[0293] The support rod is rod-shaped, which is easy to process and has lower processing costs; and there are more optional materials, for example, hard metal can be used to improve the structural strength of the support component of the first handle, and improve the connection stability between the first handle and the second handle, that is, the support rod is not easy to bend or break when the second handle is away from the first handle.

[0294] In addition, in order to ensure the sliding stability of the second handle, two support rods are provided. In addition, due to the structural shape of the support rods, their cross-section is small, and they occupy less space, which is convenient for arrangement in the space inside the second handle.

[0295] The control handle 400 includes a mounting channel 403 axially extending through the first support body 410 and the second support body 420. The mounting channel 403 allows the catheter assembly 200 to pass through. The first support body 410 includes a first main body 411 and a first connecting seat 412. The first main body 411 is cylindrical and extends axially. The first connecting seat 412 is fixed to the proximal end of the first main body 411. Two connecting sleeves 440 are fixed to the first connecting seat 412 and are located on either side of the mounting channel 403 in the radial direction. Specifically, the connecting sleeves 440 are integrally formed with the first main body 411 and have an open proximal end for insertion of the strut 450.

[0296] The connection between the support rod 450 and the connecting sleeve 440 is as follows:

[0297] As shown in Figures 12, 35 and 38, the side wall (radially outer side) of the connecting sleeve 440 and the distal end of the support rod 450 are provided with corresponding positioning holes 441, and are fixedly connected by a connecting member 442 passed through the positioning hole 441. For example, the connecting member 442 is a screw, and a threaded hole that cooperates with the screw is provided on the support rod 450.

[0298] As shown in Figures 35 and 39, in one embodiment, the first connecting base 412 is a shell structure with a semi-cylindrical surface, wherein the shell structure serves as a portion of the outer shell and is grippable. The first support body 410 also includes a first half shell 414 that is fastened to the first connecting base 412 and forms a cylindrical shape with the shell structure. A connecting sleeve 440 is located at the junction of the first connecting base 412 and the first half shell 414. The outer wall of the connecting sleeve 440 is provided with a buckle 415 that mates with the first half shell 414.

[0299] In a preferred embodiment, the first half-shell 414 is installed in a radial direction, and the inner wall of the first half-shell 414 is provided with a limiting rib 416 that abuts against the connecting sleeve 440 to limit the axial movement of the first half-shell 414. Specifically, after the first half-shell 414 is assembled, the limiting rib 416 abuts against one end surface of the buckle 415 located on the connecting sleeve 440 along the axial direction of the control handle.

[0300] Part of the structure of the first support body 410 also serves as part of the outer shell, which saves manufacturing costs and simplifies the connection method with the outer shell.

[0301] Referring again to FIG. 24 and FIG. 35 , in one embodiment, the first connecting seat 412 is disposed on a side opposite to the notch of the first guide groove 4102 , and the line connecting the two connecting sleeves 440 is arranged at 90 degrees to the direction of the notch.

[0302] As shown in Figures 40 and 41, in one embodiment, the proximal end of the third sliding groove 4211 on the second body 421 is the end portion extending to the outer periphery of the third connecting seat 423, and a mutually cooperating snap-fit ​​structure is provided between the groove wall of the end portion and the support rod 450. Specifically, the snap-fit ​​structure includes:

[0303] The clamping block 4231 is protruded from the wall of the third sliding groove 4211;

[0304] Slot 4501 is provided on support rod 450 and engages with block 4231. When second handle 42 is in the first extreme position, block 4231 and slot 4501 engage with each other. Specifically, slot 4501 is provided near the proximal end of support rod 450. This engaging structure provides only a certain amount of damping. After the sliding locking mechanism is unlocked, applying a certain external force to the second handle releases the engagement. This engaging structure prevents the operator from accidentally unlocking the sliding locking mechanism and causing the second handle to slide, thereby improving user safety.

[0305] As shown in Figures 42 and 43, in one embodiment, the proximal portion of the support rod 450 is provided with an anti-slip member 451. When the second handle slides proximally relative to the first handle to an extreme position (i.e., the second extreme position), the anti-slip member 451 is blocked by the partition. The anti-slip member 451 can be integrally formed with the support rod 450 or fixed separately. For example, the anti-slip member 451 is a screw, wherein the screw includes a screw 4512 screwed into the support rod 450 and a nut 4511 protruding from the upper surface of the support rod 450. When the second handle 42 is in the second extreme position, the nut 4511 abuts against the end face of the second partition 4221b. During assembly, the support rod 450 is first inserted through the second partition 4221b, and then the anti-slip member 451 is installed.

[0306] With reference to Figures 44 and 45 , the present application further provides an artificial implant 100, comprising a cylindrical stent 110 with a grid structure 111. The interior of the stent 110 defines a blood flow channel 150, and multiple leaflets 120 within the stent cooperate with each other within the blood flow channel to relatively open or close the blood flow channel 150. The stent 110 has a corresponding axial direction (axial direction), a radial direction perpendicular to the axial direction, and a circumferential direction arranged around the axis. The grid structure can be understood as a cylindrical sidewall with a hollowed-out area, the edges of which are the bars that form the grid. The size and specific shape of the grid are not strictly limited. In the axial direction of the stent, the inflow side 112 and the corresponding outflow side are defined according to the normal blood flow direction in the body. The stent itself can be cut or woven from tubing, and the material used is determined according to the method of release in the body (e.g., self-expansion or balloon expansion).

[0307] Among them, the artificial implant 100 also includes an inner coating 140 connected to the stent 110 and located in the blood flow channel. The inner coating 140 is generally connected to the frame bar corresponding to the stent position by sewing, wherein the outflow side of the inner coating 140 is spliced ​​with the inflow side of each leaflet 120, and the splicing method is, for example, sewing. The artificial implant 100 also includes a plurality of anti-leakage components 130, and the plurality of anti-leakage components 130 are arranged along the circumference of the stent 110 and embedded in the corresponding grid structure 111. The plurality of anti-leakage components 130 are closed around the circumference of the stent 110, and all grid structures in the same circle are filled and embedded with the anti-leakage components 130. The anti-leakage components 130 protrude from the corresponding grid structure and are used to interact with the surrounding tissues in the body to prevent blood from passing through the periphery of the artificial implant. The anti-leakage components 130 are connected to the inner coating 140, and the two are fixed by at least one of bonding, heat fusion, suturing, infiltration or dipping. The lock seat 31 , the lock wire 33 and the lock rod 32 constitute a wire control mechanism.

[0308] The present application also provides a novel wire control mechanism for locking and releasing an artificial heart valve. Referring to Figures 46, 47, 48, and 49, the wire control mechanism of the artificial implant has a distal end and a proximal end relative to each other, and the wire control mechanism includes:

[0309] The lock base 31 includes, from distal to proximal end, a guide portion 311, a reduced diameter portion 312, and a connecting portion 313. The connecting portion 313 is provided with a lock hole 315 and a thread hole 314. The guide portion 311 is provided with a guide hole 316 corresponding to the position of the lock hole 315. The outer periphery of the reduced diameter portion 312 is a radially open bonding area 317. The distal end of the connecting portion 313 is convergent and forms an expansion area 318 on the outer periphery that communicates with the bonding area 317.

[0310] The locking rod 32 is slidably engaged with the locking base 31 and is inserted into the locking hole 315 through the guide hole 316;

[0311] The locking wire 33 has a driving end at one end and extends proximally through the wire hole 314 , and a working end at the other end for passing through the artificial implant and then being coupled to the locking rod 32 .

[0312] The structure of the lock seat 31 in the prior art is shown in Figure 7. The lock seat 31 includes a guide portion 311, a reduced diameter portion 312 and a connecting portion 313, wherein the connecting portion 313 is generally cylindrical, and a lock hole 315 and a wire hole 314 are provided on the connecting portion 313. When the locking rod 32 is inserted into the lock hole 315 of the connecting portion 313 through the guide hole 316 in the guide portion 311, precise alignment is required. Since the sizes of the locking rod 32, the lock hole 315 and the guide hole 316 are all small, extremely high processing accuracy is required. At the same time, when the working end of the locking wire 33 is passed through the artificial implant, it is operated in the outer area of ​​the reduced diameter portion 312 (that is, the connecting area 317). The operating space is small and the line of sight is easily blocked.

[0313] In the present application, the structure of the locking seat 31 is shown in Figures 46 to 48. The distal end of the connecting portion 313 of the locking seat 31 is converged and forms an expansion area 318 connected to the coupling area 317 on the periphery. The distal ends of the locking hole 315 and the wire hole 314 on the connecting portion 313 are exposed in the expansion area 318. The area range of the expansion area 318 is shown in the dotted box in Figure 47. It is an area surrounding the connecting portion 313 and having a triangular cross-section. This area is an area of ​​the operable locking wire 33 relative to the coupling area 317 around the locking seat 31 in the prior art. As shown in Figure 49, the locking hole 315 and the wire hole 314 on the connecting portion 313 are both exposed in the expansion area 318. The locking wire 33 passes through the wire hole 314 and is connected to the artificial implant. The opening size of the wire hole 314 is relatively large, and it is not easy for the locking wires 33 to get entangled. At the same time, the line of sight is better when passing through the artificial implant.

[0314] As shown in Figure 49, the opening of the lock hole 315 is relatively large, and the opening of the lock hole 315 is on an inclined surface. When the locking rod 32 is to be inserted into the lock hole 315, it is guided by the inclined surface and enters the lock hole 315, which reduces the difficulty of alignment.

[0315] The present application also provides a delivery system for an artificial implant, having a distal end and a proximal end relative to each other, the delivery system including a control handle 400 and a wire control mechanism having a proximal end connected to the control handle 400, the artificial implant being connected to the distal end of the wire control mechanism and being controlled by the control handle 400;

[0316] The control handle 400 includes a support body (i.e., a first support body 410) with a guide groove (i.e., a first guide groove 4102), a base (i.e., a first base 491) that moves along the guide groove, and a drive sleeve (i.e., a first drive sleeve 481) rotatably mounted on the outer periphery of the support body, with threaded transmission between the drive sleeve and the base.

[0317] The support body is provided with a rotation locking mechanism 460 on the proximal side of its own guide groove to limit or allow the rotation of the drive sleeve. The rotation locking mechanism 460 includes:

[0318] The first tube 461 is fixed to the support body. The control handle 400 has a mounting channel 403 extending axially through the support body. A portion of the mounting channel 403 extends through the interior of the first tube 461.

[0319] The second pipe member 462 is rotatably mounted on the outer periphery of the first pipe member 461. A portion of the second pipe member 462 is a working section 4621 extending into the driving sleeve. The outer wall of the working section 4621 has a protrusion 4622.

[0320] The locking member 463 is located in the radial gap between the working section 4621 and the drive sleeve and is configured to slide radially along the drive sleeve and act on the inner wall of the drive sleeve. During the rotation of the second tube 462, the protrusion 4622 presses against the locking member 463 to move and correspondingly lock the drive sleeve.

[0321] The operating component 464 drives the second pipe 462 to rotate.

[0322] The delivery system for artificial implants also includes:

[0323] The inner sheath tube 230 and the lock seat 31 are fixed to the distal end of the inner sheath tube 230;

[0324] The inner core 210 is slidably disposed in the inner sheath 230. The distal end of the inner core 210 passes through the lock seat 31 and a locking rod 32 is fixed to the protruding portion. The locking rod 32 moves with the inner core 210 and has the following positions:

[0325] In the locked position, the locking rod 32 is inserted into the locking hole 315 to constrain the working end of the locking wire 33;

[0326] In the release position, the locking rod 32 is disengaged from the locking hole 315 to release the working end of the locking wire 33 .

[0327] The wire-controlled tube 220 is slidably inserted into the radial gap between the inner core 210 and the inner sheath 230 , and the driving end of the locking wire 33 is connected to the wire-controlled tube 220 .

[0328] There are multiple locking rods 32 of varying lengths. In the released position, the proximal ends of all locking rods 32 are located within the guide holes 316 of the guide portion 311. As shown in FIG47 , there are at least two, and may be three, or more, locking rods 32. The lengths of the locking rods 32 vary. The axial length of the guide portion 311 is lengthened to ensure that when the locking rods 32 are in the released position, the proximal ends of all locking rods 32 are located within the guide holes 316 of the guide portion 311, rather than being exposed outside the guide portion 311. Since the proximal ends of the locking rods 32 are continuously located within the guide holes 316, the locking rods 32 and the lock base 31 are always connected, allowing the locking rods 32 to switch between the locked and released positions more smoothly and safely.

[0329] The present application also provides a delivery system for an artificial implant with a bending adjustment function. The delivery system has a relative distal end 402 and a proximal end 401. The delivery system includes a control handle 400 and a catheter assembly 200 whose proximal end is connected to the control handle 400. The artificial implant 100 is connected to the distal end of the catheter assembly 200 and is controlled by the control handle 400. The control handle 400 includes a first handle 41 and a second handle 42 that cooperate with each other. Each handle includes a support member and a driving mechanism arranged on the support member. The first handle is used to drive the outer sheath 240 to move relative to each other to achieve the expansion or folding of the artificial implant. For example, the outer sheath moves along the proximal end to expand the artificial implant folded or compressed in the outer sheath. This embodiment is different from the previous embodiment in that a bending adjustment piece is further provided, which can be a bending adjustment tube or a bending adjustment wire. The second handle 42 is provided with a bending adjustment drive mechanism for driving the movement of the bending adjustment piece, and the bending of the distal end of the catheter assembly is achieved by tensioning the bending adjustment piece. Specifically, the bending adjustment drive mechanism can be implemented in the manner described in the above embodiment. The distal end of the bending adjustment piece can be connected to the outer sheath or the inner shaft assembly, and the proximal end of the bending adjustment piece is fixed to the second base 492. The movement of the bending adjustment piece is achieved by the threaded cooperation between the second drive sleeve 482 and the second base 492, thereby changing the distal direction of the outer sheath or the inner shaft assembly.

[0330] In one embodiment, the second handle 42 is further provided with a release drive mechanism for driving the release of the artificial implant. For example, the release drive mechanism is a control mechanism that drives the movement of the control wire 34. The control wire 34 includes a first end 341 and a second end 342 connected to the second handle 42. One end is fixedly connected to the second handle 42 (also called a fixed end), and the other end is movably connected to the second handle 42 (a movable end), or both ends are movably connected. The movable connection method is, for example, connected to the second base, and the second base is driven to slide by the second drive sleeve thread to loosen or tighten the control wire 34.

[0331] As for the control line 34 as a whole, its distal end passes through the artificial implant 100. The passing portion can be the structural gap or the connection hole opened on the proximal side of the artificial implant 100. The artificial implant 100 is controlled accordingly by loosening or tightening the control line 34.

[0332] After the artificial implant 100 is deployed, it needs to be separated from the control line 34. The method that can be used is that the fixed end and / or the movable end of the control line 34 can be disconnected from the second handle 42. For example, the movable end is clamped and fixed to the second base, and when it needs to be released, the clamp is released to loosen the movable end and pull it out of the artificial implant 100; for example, the fixed end is connected to the second handle 42 by clamping or fasteners, and when it needs to be released, the fixed end is released accordingly.

[0333] In other embodiments, the control line 34 can be cut by shearing or other methods to separate it from the artificial implant 100. For example, a wire breaking mechanism can be configured in the second handle 42, or an additional wire breaking device can be used to cut the wire. Of course, local melting can also be used to cut the wire.

[0334] As for the breaking point of the control wire 34, the wire can be broken on the proximal side, for example, near the fixed end and / or the movable end, or it can be broken at the distal end, for example, the wire breaking instrument can extend to the distal end and near the connection point between the control wire 34 and the artificial implant 100.

[0335] As shown in Figures 50 to 53, in another embodiment, the inner shaft assembly includes an inner core 210 and an inner sheath 230, wherein the distal end of the inner sheath 230 is connected to a locking seat 35, and the proximal end of the inner sheath is fixed to the handle and is fixed relative to the handle; one end of the inner core 210 is an extension section extending from the distal end of the inner sheath 230, and the other end can be fixed to the locking seat 35 or extend through the locking seat 35, the first end 341 of the control line 34 serves as the movable end and is connected to the second handle, and the second end 342 is located at the distal end and passes through the locking seat 35 and the artificial implant 100 in sequence, then extends to the proximal end and is connected to the locking seat 35. For example, a barb can be provided on the wall of the locking seat 35 for connecting the second end 342.

[0336] Similarly, the movable end can be connected to the third base and driven by the second drive sleeve thread, and the anti-detachment structure at the distal end can utilize its own shape change or cooperate with other components to limit or release the connection with the artificial implant 100.

[0337] For example, the catheter assembly may further include a retaining member 260 for limiting the second end 342 from being separated from the artificial implant 100 .

[0338] The retaining member 260 acts on the second end 342 to keep the artificial implant under the action of the control line to further restrict the second end from being separated from the lock seat. The second end 342 has a movement path for switching to a separated state, and the retaining member 260 has:

[0339] The first position prevents the second end 342 from switching to the separated state;

[0340] The second position allows the second end 342 to be switched to a separated state.

[0341] The retaining member 260 slides axially. For example, the retaining member 260 is tubular and is slidably sleeved on the outer periphery of the inner sheath 230. The proximal end of the retaining member 260 is connected to the base of the second handle (for example, the second base).

[0342] The second end of the control line 34 is provided with an anti-detachment structure 343 to prevent it from unexpectedly detaching from the artificial implant 100 .

[0343] In the locked state, the anti-slip structure 343 and the lock seat 35 have a combined state in which they are connected to each other, and a separated state in which the connection relationship is released.

[0344] The anti-slip structure 343 may have an enlarged end, such as a winding or spiral structure as shown in Figure 54. The outer periphery of the lock seat 35 may also be provided with a coupling groove 351. In the coupled state, the anti-slip structure 343 is placed in the coupling groove 351 and is wrapped by the retaining member 260 (as shown in Figure 52). In the separated state, the anti-slip structure is detached from the coupling groove (as shown in Figure 53).

[0345] There may be one or more control lines 34 , and the retaining member 260 may be configured for each control line 34 , or all control lines 34 may share the same retaining member 260 .

[0346] In one embodiment, the anti-detachment structure is made of a deformable material, which limits or releases the connection with the artificial implant 100 by changing its shape. For example, the anti-detachment structure is made of a memory alloy material, such as nickel-titanium wire.

[0347] After the distal end of the control line 34 passes through the artificial implant 100, the anti-detachment structure bends or coils itself and is in a first state to maintain connection with the artificial implant 100. When release is required, the anti-detachment structure deforms, the bent or coiled part unfolds and is in a second state, allowing it to be detached from the artificial implant 100.

[0348] In one embodiment, the anti-slip structure can be heat-set in a second state, and the conveying system also includes a retaining member that limits the anti-slip structure to the first state. The retaining member can act on the anti-slip structure by clamping, squeezing, etc. When the retaining member is separated from the anti-slip structure or the matching method is changed, the anti-slip structure drives itself to return to the second state.

[0349] In one embodiment, the anti-slip structure can be heat-set in a first state, and the conveying system also includes a driving member that drives the anti-slip structure to switch to a second state. For example, the driving member can also use an electrical signal to drive the anti-slip structure to deform toward the second state.

[0350] In the delivery system of the present application, the support rod serves as a connecting member between the second handle and the first handle, and can also improve the structural strength of the control handle. It cooperates with the sliding locking mechanism to maintain the length of the control handle and meet operational requirements, such as the rapid retraction of the artificial implant and precise control of the artificial implant during retrieval.

[0351] 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.

[0352] 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 delivery system for an artificial implant, having opposite distal and proximal ends, the delivery system comprising a control handle and a catheter assembly proximally connected to the control handle, characterized in that, The control handle includes a first handle and a second handle that cooperate with each other; the catheter assembly includes an outer sheath tube and an inner shaft assembly located inside the outer sheath tube. The artificial implant is connected to the distal end of the inner shaft assembly and is controlled by the control handle. The first handle is used to drive the axial movement of the outer sheath tube to realize the deployment and folding of the artificial implant; the second handle is used to control the release of the artificial implant to realize the separation of the artificial implant from the delivery system.

2. The delivery system of the artificial implant according to claim 1, wherein Each handle includes a support member and a drive mechanism provided on the support member; The support member in the first handle includes a first support body and a strut fixed to the first support body and further extending in the proximal direction. The support member in the second handle includes a second support body slidably mounted on the strut. A sliding locking mechanism is further provided on the distal side of the second support body itself. The sliding locking mechanism acts on the strut to maintain the relative position with the first support body.

3. The delivery system of the artificial implant according to claim 2, wherein, A limiting member is provided on the strut, and the sliding locking mechanism cooperates with the limiting member to maintain the relative position of the second handle relative to the first support body.

4. The delivery system of the artificial implant according to claim 3, characterized in that, The limiting member is a positioning tooth, and the number of the positioning teeth is multiple and arranged at intervals along the axis.

5. The delivery system of the artificial implant according to claim 3, characterized in that, The sliding locking mechanism includes: A locking member, movably mounted on the second support body, having a locking position that cooperates with the limiting member and an unlocking position that disengages from the limiting member; An elastic member, acting between the locking member and the second support body, driving the locking member towards the locking position; An operation button, acting in linkage with the locking member, driving the locking member towards the unlocking position.

6. The delivery system of the artificial implant according to claim 5, characterized in that, The locking member is provided with an assembly hole and is sleeved on the strut through the assembly hole in a sliding manner. There is a moving gap between the assembly hole and the strut in the direction perpendicular to the sliding direction of the strut. The locking member moves along this moving gap during the process of switching positions.

7. The delivery system of the artificial implant according to claim 6, characterized in that, One side wall of the assembly hole faces the limiting member, and an engaging portion that cooperates with the limiting member is provided on this side wall.

8. The delivery system of the artificial implant according to claim 5, characterized in that, The struts are two and arranged side by side along the axial direction of the control handle. Two sets of sliding locking mechanisms are configured and act on the corresponding strut respectively; A resisting rib is fixed inside the second support body. The elastic member is pressed and acts between the resisting rib and the locking member. The resisting ribs in the two sets of sliding locking mechanisms are arranged at intervals, and the interval area is for the installation channel to extend through. The locking member is provided with a positioning seat on the side facing the elastic member, and the elastic member is inserted into or sleeved on the positioning seat.

9. The delivery system of the artificial implant according to claim 2, wherein, The struts are two and arranged side by side along the axial direction of the control handle.

10. The delivery system of the artificial implant according to claim 9, characterized in that, Two sets of sliding locking mechanisms are configured and act on the corresponding strut respectively; The sliding locking mechanism is provided with an operation button for unlocking. The operation buttons in the two sets of sliding locking mechanisms are aligned with each other along the radial direction of the second handle and are arranged in opposite directions.

11. The delivery system of the artificial implant according to claim 1, characterized in that, The delivery system is connected to the distal end of the artificial implant through a wire to realize the folding or compression of the artificial implant.

12. The delivery system of the artificial implant according to claim 11, wherein A wire control mechanism is provided at the distal end of the second handle or the catheter assembly. The wire control mechanism includes a clamping and / or releasing mechanism for the wire.

13. The delivery system of the artificial implant according to claim 1, wherein The inner shaft assembly includes two shafts whose proximal ends are respectively connected to the second handle; the inner shaft assembly as a whole is movable relative to the first handle.

14. The delivery system of the artificial implant according to claim 1, wherein, The inner shaft assembly includes a first shaft, a second shaft, and a third shaft whose proximal ends are respectively connected to the second handle; the third shaft is fixedly connected to the second handle, and the first shaft and the second shaft are movably connected to the second handle.

15. The delivery system of the artificial implant according to claim 13 or 14, characterized in that, One of the shafts in the inner shaft assembly is a bending adjustment shaft or a bending adjustment wire.

16. The delivery system of the artificial implant according to claim 1, wherein The inner shaft assembly includes a first shaft, a second shaft, and a third shaft whose proximal ends are respectively connected to the second handle; A lock seat is connected to the distal end of the third shaft, and the lock seat is provided with a lock hole or a groove; A lock wire is connected to the distal end of the second shaft, and the lock wire is used to wind around the artificial implant and then connected to the lock seat to bind or release the artificial implant; A lock rod is connected to the distal end of the first shaft or a convex structure is arranged circumferentially, for maintaining the connection between the lock wire and the lock seat.

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