Artificial implant conveying system convenient to control

Abstract

The invention discloses an artificial implant delivery system convenient to control, which comprises a control handle and a catheter assembly, the control handle comprises a first handle and a second handle which are matched with each other, and each handle comprises a support member and a driving mechanism arranged on the support member; the supporting body is provided with a guide groove extending in the axial direction, the driving mechanism comprises a base moving along the guide groove and a driving sleeve rotationally installed on the periphery of the corresponding supporting body, the driving sleeve and the base are in threaded transmission, and the near end side of the guide groove of the supporting body is provided with a rotary locking mechanism capable of limiting or allowing the driving sleeve to rotate. The switching of the locking state and the unlocking state of the rotary locking mechanism is beneficial to the in-vivo control of the artificial implant and is convenient for an operator to operate.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to a delivery system for an artificial implant that is convenient to control. Background Art

[0002] Percutaneous artificial heart valve replacement and repair is an advanced cardiac valve interventional therapy technology. Through an interventional approach, it is possible to repair or replace the heart valve without open-chest surgery.

[0003] Among them, the artificial implant generally controls various spatial postures in the body through wire harnesses and / or tubes, etc. Considering the diversity of the spatial postures of the artificial implant and the switching of each posture during operations such as delivery, release, and retrieval in the body, and at the same time, the operator needs to take into account the convenience and accuracy of the operation during actual operation. Therefore, relatively high requirements are imposed on the entire delivery system. Summary of the Invention

[0004] The present application provides a delivery system for an artificial implant that is convenient to control.

[0005] The present application provides a delivery system for an artificial implant, having opposite distal and proximal ends. The delivery system includes a control handle and a catheter assembly proximally 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 includes a first handle and a second handle that cooperate with each other. Each handle includes a support member and a drive mechanism provided on the support member;

[0006] The support member in the first handle includes a first support body and a strut fixed to the first support body and further extending proximally. The support member in the second handle includes a second support body slidably mounted on the strut; each support body is provided with a guiding groove extending axially. The drive mechanism includes a base moving along the guiding groove and a drive sleeve rotatably mounted on the periphery of the corresponding support body. A threaded drive is provided between the drive sleeve and the base;

[0007] Each support body is respectively provided with a rotation locking mechanism on the proximal side of its own guiding groove that can limit or allow the drive sleeve to rotate. 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.

[0008] The following also provides several optional ways, but they are not additional limitations to the above overall solution. They are merely further supplements or optimizations. On the premise of no technical or logical contradictions, each optional way can be combined with the above overall solution alone, or multiple optional ways can be combined with each other.

[0009] Optionally, the catheter assembly sequentially includes an outer sheath tube and at least one shaft from outside to inside, specifically:

[0010] The outer sheath tube is movably connected to the first base in the first handle at the proximal end and is used for covering the artificial implant at the distal end.

[0011] The third shaft is fixed to the second handle at the proximal end.

[0012] The second shaft is movably connected to the second base in the second handle at the proximal end.

[0013] The first shaft is movably connected to the proximal part of the second handle at the proximal end.

[0014] Optionally, a first extension sleeve is further fixed to the distal end of the first support body, and the catheter assembly further includes:

[0015] A sheath, which is located outside the outer sheath tube, and the proximal end of the sheath is fixed to the first extension sleeve.

[0016] Optionally, a first support is fixed inside the first extension sleeve, the proximal end of the sheath is fixed to the first support, the outer sheath tube penetrates through the first support in a sealed manner, and the first support is provided with a first exhaust structure.

[0017] Optionally, a second support is fixed to the distal part of the second support body, the proximal end of the third shaft is fixed to the second support, the second shaft penetrates through the second support in a sealed manner, and a second exhaust structure is provided on the second handle.

[0018] Optionally, the first exhaust structure and the second exhaust structure are one-way valves.

[0019] Optionally, a second extension sleeve is further fixed to the proximal end of the second support body, and the driving mechanism includes:

[0020] A first driving mechanism, which is arranged on the first support body and is linked with the outer sheath tube;

[0021] A second driving mechanism, which is arranged on the second support body and is linked with the second shaft;

[0022] A third driving mechanism, which is arranged on the second extension sleeve and is linked with the first shaft.

[0023] Optionally, the third driving mechanism includes a third base slidably installed in the second extension sleeve, and a third driving sleeve threadedly engaged with the third base and rotatably installed on the second extension sleeve.

[0024] Optionally, the second extension sleeve is provided with a third support, the second exhaust structure is arranged on the third support, and an exhaust pipe penetrating through the second support body is arranged between the third support and the second support.

[0025] Optionally, the distal part of the second support body includes a partition arranged axially, the partition is provided with a through hole for the exhaust pipe to pass through, and a groove serving as the channel is formed on the second support body.

[0026] Optionally, 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;

[0027] A lock wire is connected to the distal end of the second shaft, and the lock wire is used to be wound around the artificial implant and then connected to the lock seat to bind or release the artificial implant;

[0028] A lock rod is connected to the distal end of the first shaft or a convex structure is arranged circumferentially to keep the lock wire connected to the lock seat.

[0029] Optionally, one end of the lock wire is a driving end and is connected to the second shaft, and the other end of the lock wire is a working end. After the working end is wound around the artificial implant, it is tightened or loosened on the lock seat.

[0030] Optionally, the lock wire is provided with a radiopaque marker.

[0031] Optionally, the distal end of the lock wire is provided with a radiopaque marker.

[0032] Optionally, the radiopaque marker is connected to the lock wire by processes such as bonding, sewing, braiding, and riveting.

[0033] The control handle includes a rotating member sleeved on the support body. The rotating member is of a cylindrical structure and has opposite inner and outer walls. The rotation locking mechanism includes:

[0034] A first pipe fitting fixed to the support body. There is an installation channel axially penetrating through the support body inside the control handle, and a part of the installation channel extends through the inside of the first pipe fitting;

[0035] A second pipe fitting rotatably sleeved on the outer periphery of the first pipe fitting. A part of the second pipe fitting is a working section extending into the rotating member, and a convex portion is provided on the outer wall of the working section;

[0036] A locking member located in the radial gap between the working section and the rotating member and configured to be able to slide radially along the rotating member and act on the inner wall of the rotating member. During the rotation of the second pipe fitting, the convex portion presses against the locking member to move and act on the corresponding rotating member to be locked;

[0037] The operating component drives the second pipe fitting to rotate.

[0038] Optionally, the support body and the side wall of the first pipe fitting are partially open towards the same side in the radial direction to form a mounting opening.

[0039] Optionally, the side wall of the second pipe fitting is open towards one side in the radial direction, and the open position is circumferentially misaligned with the open position of the first pipe fitting.

[0040] Optionally, the support body includes:

[0041] A main body, which is columnar and extends along the axial direction of the control handle, and the first pipe fitting is located on the proximal side of the main body;

[0042] A connecting seat, which is fixed to the proximal end of the main body and has a radial gap with the first pipe fitting, and the radial position of the second pipe fitting is located in the radial gap.

[0043] Optionally, the connecting seat is integrally a shell structure with a semi-cylindrical surface, and the support body further includes a semi-shell that is fastened and fixed to the connecting seat and encloses a cylindrical shape. The semi-shell is provided with an avoidance window, and the operating component is exposed to the avoidance window.

[0044] Optionally, the connecting seat is provided with a radially penetrating guiding groove, and the locking member includes a first locking member slidably disposed in the guiding groove, and the protruding portion on the second pipe fitting abuts against the radial inner side of the first locking member.

[0045] Optionally, the groove wall of the guiding groove is provided with a registration structure that cooperates with the first locking member.

[0046] Optionally, the locking member includes:

[0047] A first locking member, which is slidably fitted into the connecting seat;

[0048] A second locking member, which is radially movably buckled with the connecting seat, and the first locking member and the second locking member move synchronously and in opposite directions.

[0049] Optionally, the second locking member is semi-circular and is provided with a guiding structure that cooperates with the support body.

[0050] Optionally, the connecting seat has a blocking portion that abuts against the operating component to limit its rotation amplitude.

[0051] Optionally, the first locking member and the second locking member have the same axial position and are located on two opposite sides in the radial direction of the second pipe fitting.

[0052] Optionally, there are a plurality of locking members arranged axially.

[0053] Optionally, a stop member is embedded at the position where the locking member cooperates with the rotating member.

[0054] Optionally, the first locking member and the second locking member are made of a hard material, and the stop member is made of a soft material.

[0055] Optionally, the rotating member is a driving sleeve, and the driving sleeve is rotatably sleeved on the outer periphery of the support body.

[0056] Optionally, the height of the outer surface of the convex portion gradually increases along the circumferential direction of the second pipe fitting.

[0057] Optionally, the second pipe fitting has opposite:

[0058] A locking position where the convex portion abuts against the locking member and acts on the rotating member;

[0059] A release position where the convex portion releases the abutting force against the locking member;

[0060] The locking member has an arc surface or a radial undulating structure that cooperates with the convex portion.

[0061] Optionally, there are two struts arranged side by side and positioning teeth are arranged on the opposite sides.

[0062] The second support body is provided with guiding holes, and the two struts extend into the corresponding guiding holes, and the sliding locking mechanism cooperates with the positioning teeth to maintain the relative position of the second handle relative to the first support body.

[0063] Optionally, the two struts are slidably matched with the guiding holes.

[0064] Optionally, the strut is a metal strip, and the cross section of the metal strip is strip-shaped and the extending direction is perpendicular to the direction of the spaced arrangement of the two struts.

[0065] Optionally, the sliding locking mechanism includes:

[0066] A locking member movably installed on the second support body, having a locking position where it engages with the positioning teeth and an unlocking position where it disengages from the positioning teeth;

[0067] An elastic member acting between the locking member and the second support body, driving the locking member towards the locking position;

[0068] An operation button acting on the locking member, driving the locking member towards the unlocking position.

[0069] Optionally, the locking member is provided with an assembly hole and is sleeved on the support rod through the assembly hole and slides thereon. There is a clearance between the assembly hole and the support rod in a direction perpendicular to the sliding direction of the support rod, and the locking member moves along this clearance during the process of switching positions.

[0070] Optionally, one side of the assembly hole faces the positioning teeth, and an engaging portion that cooperates with the positioning teeth is provided on this side.

[0071] Optionally, the engaging portion is one or more teeth arranged at intervals along the sliding direction of the locking member.

[0072] Optionally, two sets of sliding locking mechanisms are configured and act on corresponding support rods respectively. The operating buttons in the two sets are aligned with each other radially with respect to the second handle and are arranged in opposite directions.

[0073] Optionally, a resisting rib is fixed inside the second support body, and the elastic member is pressed between the resisting rib and the locking member.

[0074] Optionally, the resisting ribs in the two sets of sliding locking mechanisms are arranged at intervals, and the interval area allows the installation channel to extend through.

[0075] Optionally, a positioning seat is provided on one side of the locking member facing the elastic member, and the elastic member is inserted into or sleeved on the positioning seat.

[0076] Optionally, the elastic member is a spring.

[0077] Optionally, the distal part of the second support body is a second connecting seat, which includes two partition plates and a transition part connected between the two partition plates;

[0078] The transition part is a shell structure with a semi-cylindrical surface as a whole. The second support body further includes a second half shell that is fastened and fixed to the transition part to enclose a cylindrical shape. The sliding locking mechanism is located in the area surrounded by the transition part and the second half shell, and only a part of the operating button is exposed.

[0079] Optionally, the second support body further includes a clamping seat clamped between the second connecting seat and the second half shell. The clamping seat is provided with an open slot for the operating button to be exposed.

[0080] Optionally, the open slot is circumferentially closed and extends along the movement direction of the operating button.

[0081] Optionally, there are two support rods. Two connecting sleeves are fixed at the proximal part of the first support body, and the distal parts of the two support rods are fixedly inserted into the corresponding connecting sleeves;

[0082] The distal part of the second support body includes two partition plates arranged at axial intervals, and each partition plate is provided with a guiding hole. The second support body is respectively provided with third sliding grooves extending axially on two radially opposite sides. Each strut passes through the corresponding guiding hole and is placed in the corresponding third sliding groove, and the second handle slides relative to the first handle along the two struts as a whole.

[0083] Optionally, the second handle has two limit positions relative to the first handle along the two struts, namely a first limit position where the second handle abuts against the first handle and a second limit position where the second handle is far away from the first handle.

[0084] Optionally, the control handle is internally provided with an installation channel axially penetrating through the first support body and the second support body. The first support body includes:

[0085] A first main body, which is columnar and extends along the axial direction of the control handle;

[0086] A first connecting seat, 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 the radial direction.

[0087] Optionally, the side wall of the connecting sleeve and the distal end of the strut are provided with positioning holes corresponding in position, and are fixedly connected by a connecting piece passing through the positioning holes.

[0088] Optionally, the first connecting seat is a shell structure with a semi-cylindrical surface as a whole, and the first support body further includes a first half shell that is fastened and fixed to the first connecting seat and encloses a cylindrical shape.

[0089] 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 cooperates with the first half shell.

[0090] Optionally, a partial area of the first main body is radially penetrated to form a first guiding groove. The driving mechanism includes:

[0091] A first base, slidably arranged in the first guiding groove, and the first base is used to connect a controlled component;

[0092] A first driving sleeve, rotatably sleeved on the outer periphery of the first support body, and a threaded transmission fit is provided between the inner wall of the first driving sleeve and the first base.

[0093] Optionally, the control handle is internally provided with an installation channel axially penetrating through the first support body and the second support body. The second support body includes:

[0094] The second body is columnar and extends along the axial direction of the control handle, and the third chute is located on the side of the second body facing away from the installation channel;

[0095] The second connecting seat includes the two partition plates and a transition part connected between the two partition plates, and one of the partition plates is fixed to the distal end of the second body;

[0096] The third connecting seat is fixed to the proximal end of the second body.

[0097] Optionally, the two partition plates include a first partition plate at the distal end and a second partition plate at the proximal end. A cover plate is buckled on the distal side of the first partition plate, and the cover plate is provided with an avoidance area corresponding to the positions of the installation channel and the guiding hole.

[0098] Optionally, a positioning rib extending radially is provided on the distal side of the first partition plate, and a positioning groove cooperating with the positioning rib is provided on the cover plate.

[0099] Optionally, the two partition plates extend openly along the first radial direction from the positions of their respective installation channels to their own edges;

[0100] The cover plate extends openly along the second radial direction opposite to the first radial direction from the position of the installation channel to its own edge and forms the positioning groove.

[0101] Optionally, the proximal part of the third chute is the end section extending to the outer periphery of the third connecting seat, and a mutually cooperating engaging structure is provided between the groove wall of the end section and the support rod.

[0102] Optionally, the engaging structure includes:

[0103] A clamping block protruding from the groove wall of the third chute;

[0104] A clamping groove provided on the support rod and cooperating with the clamping block.

[0105] Optionally, when the second handle slides and abuts against the first handle, the clamping block is adapted to the clamping groove.

[0106] Optionally, an anti - detachment member is provided at the proximal part of the support rod. When the second handle slides proximally relative to the first handle to the limit position, the anti - detachment member is blocked by the partition plate.

[0107] Optionally, a partial area of the second body is radially penetrated to form a second guiding groove, and the driving mechanism includes:

[0108] A second base slidably arranged in the second guiding groove, and the second base is used for connecting a controlled component;

[0109] The second driving sleeve is rotatably sleeved on the outer periphery of the second support body, and the inner wall of the second driving sleeve is in threaded driving cooperation with the second base.

[0110] Optionally, the transition part is a shell structure with a semi-cylindrical surface as a whole, and the second support body further includes a second half shell that is fastened and fixed to the transition part and encloses a cylindrical shape.

[0111] Optionally, the artificial implant includes:

[0112] A stent, which is cylindrical and has a grid structure, and the inside of the stent is a blood flow channel;

[0113] Multiple valve leaflets, each valve leaflet is located in the blood flow channel and cooperates with each other to control the blood flow on and off. The edge of the valve leaflet includes a fixed edge connected to the stent and a free edge that cooperates with other valve leaflets to control the blood flow channel.

[0114] Optionally, the artificial implant further includes an inner membrane located in the blood flow channel and connected to the inner side of the stent, and a plurality of anti-peripheral leakage components connected to the inner membrane. The anti-peripheral leakage components are embedded in and protrude out of the corresponding grid structure.

[0115] The present application also provides a delivery system for an artificial implant, which has opposite distal and proximal ends. The delivery system includes a control handle and a catheter assembly proximally 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 includes a support member and a driving mechanism provided on the support member;

[0116] The support body is provided with a guiding groove extending axially. The driving mechanism includes a base moving along the guiding groove and a driving sleeve rotatably mounted on the outer periphery of the corresponding support body. The driving sleeve is in threaded driving with the base, and the support body is respectively provided with a rotation locking mechanism on the proximal side of its own guiding groove to limit or allow the driving sleeve to rotate.

[0117] In the delivery system of the artificial implant of the present application, the switching between the locked and unlocked states of the rotation locking mechanism is beneficial to the control of the artificial implant in the body and facilitates the operation of the operator. Description of the Drawings

[0118] Figure 1 It is a structural view of the delivery system according to an embodiment of the present application;

[0119] Figure 2 is Figure 1 the structural view of the control handle in

[0120] Figure 3 is Figure 1 the structural schematic diagram of the second handle sliding proximally relative to the first handle in the control handle in

[0121] Figure 4 is Figure 2 A sectional view of the control handle along its own axial direction;

[0122] Figure 5 is an exploded view of the second handle in the control handle of the present application;

[0123] Figure 6 is Figure 1 An enlarged view of part A in;

[0124] Figure 7 is a partial structural view of the cooperation between the lock rod and the lock seat in the control mechanism of an embodiment of the present application;

[0125] Figure 8 is a cross-sectional view of a catheter assembly of an embodiment of the present application;

[0126] Figure 9 is a schematic diagram of the state when the distal end of the delivery system of an embodiment of the present application releases the artificial implant and relaxes the lock wire;

[0127] Figure 10 is a schematic diagram of the state when the distal end of the delivery system of an embodiment of the present application releases the artificial implant and releases the lock wire;

[0128] Figure 11 is a structural view of the second support in the control handle of an embodiment of the present application;

[0129] Figure 12 is an exploded view between the strut and the first handle in the control handle of an embodiment of the present application;

[0130] Figure 13 is an exploded view of the sliding locking mechanism in the control handle of an embodiment of the present application;

[0131] Figure 14 is Figure 4 An enlarged view of part B (when the sliding locking mechanism is in the locked state) in;

[0132] Figure 15 is Figure 4 An enlarged view of part B (when the sliding locking mechanism is in the unlocked state) in;

[0133] Figure 16 is a structural view of the lock in the control handle of an embodiment of the present application;

[0134] Figure 17 is an assembly schematic diagram between the lock and the strut in the control handle of an embodiment of the present application;

[0135] Figure 18Structural view of the operating button in the control handle according to an embodiment of the present application;

[0136] Figure 19 Exploded view of the second half shell and the second drive sleeve in the control handle according to an embodiment of the present application;

[0137] Figure 20 Exploded view of the operating button in the control handle according to an embodiment of the present application;

[0138] Figure 21 Structural view of the card seat in the control handle according to an embodiment of the present application;

[0139] Figure 22 is Figure 2 Exploded view of the control handle between the rotating part and the support body;

[0140] Figure 23 is Figure 22 Exploded view of the locking part and the half shell;

[0141] Figure 24 is Figure 23 Structural view of the support body;

[0142] Figure 25 Front view of the second pipe fitting according to an embodiment of the present application

[0143] Figure 26 is Figure 25 Structural view of the second pipe fitting;

[0144] Figure 27 is Figure 26 Structural view of the second pipe fitting from another perspective;

[0145] Figure 28 Front view of the control handle according to an embodiment of the present application;

[0146] Figure 29 is Figure 28 Cross-sectional view in the F-F direction (locking device in the unlocked state);

[0147] Figure 30 is Figure 28 Cross-sectional view in the F-F direction (locking device in the locked state);

[0148] Figure 31 Structural view of the locking part (first locking part) according to an embodiment of the present application;

[0149] Figure 32 is Figure 31 Exploded view between the first locking part and the support body;

[0150] Figure 33 isFigure 22 Magnified view of part C;

[0151] Figure 34 is Figure 33 Exploded view between the second locking member and the support in the middle;

[0152] Figure 35 is Figure 24 Magnified view of part D in the middle;

[0153] Figure 36 is Figure 28 Cross-sectional view in the direction of E-E (locking device in unlocked state) in the middle;

[0154] Figure 37 is Figure 28 Cross-sectional view in the direction of E-E (locking device in locked state) in the middle;

[0155] Figure 38 Partial structural view of the control handle of an embodiment of the present application when the second handle is in the second extreme position;

[0156] Figure 39 Structural view of the first half shell of the control handle of an embodiment of the present application;

[0157] Figure 40 Structural view of the engaging structure between the strut and the chute of the control handle of an embodiment of the present application in cooperation;

[0158] Figure 41 is Figure 11 Partial structural view of the proximal part of the second support in the middle;

[0159] Figure 42 is Figure 38 Magnified view of part G in the middle;

[0160] Figure 43 is Figure 12 Partial structural view between the strut and the anti-disengagement member in the middle;

[0161] Figure 44 Structural view of the artificial implant of an embodiment of the present application;

[0162] Figure 45 is Figure 44 Partial view at the anti-peripheral leakage component in the middle.

[0163] Explanation of the reference numerals in the figure is as follows:

[0164] 100, artificial implant; 110, stent; 111, grid structure; 112, inflow side; 120, valve leaf; 130, anti-peripheral leakage component; 140, inner lining membrane; 150, blood flow channel;

[0165] 200. Catheter assembly; 210. Inner core; 220. Wired tube; 230. Inner sheath tube; 240. Outer sheath tube; 250. Sheath;

[0166] 31. Lock seat; 32. Lock rod; 33. Lock wire; 331. Developer mark;

[0167] 400. Control handle; 401. Proximal end; 402. Distal end; 403. Installation channel; 404. Display window;

[0168] 41. First handle; 410. First support body; 4101. Second chute; 4102. First guide groove; 411. First main body; 412. First connecting seat; 4121. Guide groove; 4122. Positioning groove; 4123. First chute; 4124. Blocking part; 414. First half shell; 415. Snap; 416. Limit rib;

[0169] 418. First extension sleeve; 4181. Avoidance window; 419. First support; 4191. First exhaust structure;

[0170] 42. Second handle; 420. Second support body; 4201. Abuttment rib; 4202. Spacer; 4203. Cardboard; 4204. Installation area;

[0171] 421. Second main body; 4211. Third chute;

[0172] 422. Second connecting seat; 4212. Second guide groove; 4213. Groove; 4221. Partition; 4221a. First partition; 4221b. Second partition; 4222. Guide hole; 4223. Transition part; 4225. Positioning rib; 4226. Avoidance hole;

[0173] 423. Third connecting seat; 4231. Block;

[0174] 424. Cover plate; 4241. Avoidance area; 4242. Positioning groove;

[0175] 425. Second half shell; 426. Card seat; 4261. Open slot;

[0176] 427. Second extension sleeve; 428. Second support; 429. Third support; 4291. Second exhaust structure;

[0177] 430. Sliding locking mechanism; 431. Locking part; 4311. Assembly hole; 4312. Activity gap; 4313. Engaging part; 4314. Card hole; 4315. Alignment seat;

[0178] 432. Elastic part; 433. Operating button; 4331. Card column;

[0179] 440. Connecting sleeve; 441. Positioning hole; 442. Connecting piece;

[0180] 450. Support rod; 4501. Card slot; 4502. Positioning tooth;

[0181] 451. Anti - detachment part; 4511. Nut; 4512. Screw rod; 452. Support bar; 453. Rack; 4521. Installation groove;

[0182] 460. Rotating locking mechanism; 461. First pipe fitting; 4611. Installation port;

[0183] 462. Second pipe fitting; 4621. Working section; 4622. Protrusion; 4623. Open port;

[0184] 463. Locking piece; 4631. First locking piece; 4632. Positioning block; 4633. First slider; 4635. Second locking piece; 4637. Avoidance area; 4638. Arc surface; 4639. Second slider

[0185] 464. Operating part; 4641. Anti - slip part; 4642. Mark; 4643. Stopper;

[0186] 470. Exhaust pipe; 480. Rotating part; 481. First driving sleeve; 482. Second driving sleeve; 483. Third driving sleeve;

[0187] 491. First base; 492. Second base; 493. Third base. Detailed implementation manners

[0188] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

[0189] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0190] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. The terms used 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 related listed items.

[0191] In this application, terms such as "first", "second", etc. are used only for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity or order of the indicated technical features. Thus, features defined with "first", "second" may explicitly or implicitly include one or more of such features. In the description of this application, "a plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0192] 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. The control handle can be connected to and control the catheter assembly for performing an interventional procedure. The catheter assembly includes a plurality of controlled components. The distal ends of the respective controlled components cooperate with each other to operate the artificial implant, such as releasing, retrieving, locking the position, adjusting the spatial attitude, etc. Each controlled component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of various forms. There are a plurality of controlled components, and at least two of them (taking the proximal end as an example) can slide relative to each other along the axis or rotate relative to each other around the axis.

[0193] The artificial implant can be an artificial heart valve or a vascular stent, etc. The artificial heart valve can include a stent and leaflets connected to the stent for controlling blood flow on and off. The number of leaflets is multiple, generally two or three. According to needs, a skirt design can also be added on the inner side and / or outer side of the stent, such as the following periprosthetic leak prevention component. The stent itself can be formed by braiding or tube cutting. The artificial heart valve can be used to replace a diseased valve in the heart, such as the aortic valve.

[0194] Hereinafter, when indicating a direction, the proximal end in the text generally refers to the side adjacent to the operator (such as a doctor), and the distal end is the relatively far side. Along the interventional path, each component itself has a relative distal end and proximal end; theoretically, when the catheter assembly and the control handle are completely straightened, a straight line is formed between the proximal end and the distal end, which determines the axis, and correspondingly, the radial direction perpendicular to the axis and the circumferential direction arranged around the axis are also determined; when referring to a structure, the "end" in the text represents the end point of the structure or a certain point or area in the side direction or a specific structure connected to this point or area.

[0195] Refer to Figures 1 - 9, the present application provides a delivery system for an artificial implant, having opposite distal end 402 and proximal end 401. The delivery system includes a control handle 400 and a catheter assembly 200 proximally 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 drive mechanism disposed on the support member. The drive mechanism is in multiple groups, and each group is connected to some components of the catheter assembly to control a control mechanism located at the distal end of the catheter assembly to complete actions such as expansion, release, and retrieval of the artificial implant. The support member is used to provide a basis for the installation and movement of the drive mechanism and / or another handle and the structural support of the corresponding handle.

[0196] The support member 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 member in the second handle 42 includes a second support body 420 slidably mounted on the struts 450. Each support body is provided with a guiding groove extending axially. The drive mechanism includes a base that slides axially along the control handle and a drive sleeve rotatably mounted on the outer periphery of the corresponding support body. The drive sleeve is in screw drive with the base. Some components in the catheter assembly are connected to the base and complete corresponding actions under the drive of the drive sleeve.

[0197] Each support body is respectively provided with a rotation locking mechanism on the proximal side of its own guiding groove to limit or allow the rotation of the drive sleeve. On the distal side of the second support body 420 itself, there is also a sliding locking mechanism. The sliding locking mechanism acts on the struts 450 to maintain the relative position with the first support body 410. The "sliding" in the "sliding locking mechanism" means that the second handle 42 slides relative to the first handle 41. The "rotation" in the "rotation locking mechanism" means that the drive sleeve rotates relative to the corresponding support body.

[0198] The catheter assembly 200 radially includes an outer sheath 240 and at least one shaft from outside to inside. One shaft means one or more shafts fixed to each other. For example, two pipe fittings fixed to each other can also be regarded as one shaft. As Figure 8 shown, the catheter assembly 200 specifically includes an outer sheath 240, a third shaft (such as the following inner sheath 230), a second shaft (such as the following wire control tube 220), and a first shaft (such as the following inner core 210). The first shaft, the second shaft, and the third shaft belong to the inner shaft assembly. Among them, the distal end of the inner core 210 is provided with a guiding head.

[0199] Refer to Figures 4 - 10, the proximal end of the outer sheath tube 240 is movably connected to the first base 491 in the first handle 41, and the distal end is used to wrap 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 part of the second handle 42. 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 move relatively away from or close to the first handle 41, so as to realize the simultaneous driving of the first shaft, the second shaft and the third shaft to move relatively quickly with respect to the outer sheath tube 240.

[0200] 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 sleeved outside the outer sheath tube 240 and having its proximal end fixed to the first handle 41.

[0201] A lock seat 31 is connected to the distal part of the inner sheath tube 230. One end of the inner core 210 is an extension section extending out of the distal end of the inner sheath tube 230. A lock rod 32 is fixed to the extension section and is located on the distal side of the lock seat 31. The distal end of the wire control tube 220 is connected to a lock wire 33. The lock wire 33 is wound around the artificial implant 100 and then tightened or loosened on the lock seat 31 to bind or release the artificial implant 100. Among them, the lock seat 31, the lock wire 33 and the lock rod 32 constitute the above control mechanism.

[0202] When the artificial implant 100 is in the loaded state, the lock wire 33 extends out of the distal end of the inner sheath tube 230, winds around the artificial implant 100 and is then bound to the lock rod 32. The lock rod 32 is inserted and matched with the lock seat 31 to limit the lock wire 33 from getting out of the binding. The proximal end of the lock wire 33 is connected to the control handle through the second shaft. In addition to being the wire control tube 220, the second shaft can also be a wire. The number of wires can be multiple and correspond to the lock wire 33 one by one. For example, the lock wire 33 and the second shaft are an integrated structure wire. In this embodiment and the accompanying drawings of the specification, the second shaft takes the wire control tube as an example.

[0203] The relative movement between the inner core 210 and the inner sheath tube 230 can realize the relative movement between the lock seat 31 and the lock rod 32, thereby changing the constraint state of the lock wire 33. The state of the lock wire 33 can affect the movement process of the artificial implant 100. Especially during the release process of the artificial implant 100, the phased release of the artificial implant 100 is realized through the lock wire 33. Further, the mutual movement of each pipe fitting can provide a structural basis for the full release and full recovery return journey of the artificial implant 100, so as to provide a more controllable interventional treatment process, improve the treatment effect and at the same time improve the patient experience. When the expanded artificial implant 100 (fully expanded but still connected to the lock wire 33) needs to be recovered, unlock the aforementioned sliding locking mechanism, and then the second handle 42 slides relative to the first handle 41 to realize the rapid retraction of the artificial implant 100 and the artificial implant 100 is received inside the outer sheath tube 240.

[0204] In one embodiment, the lock seat is provided with one or more grooves along the circumference, and the extension end is provided with a protrusion structure along the circumference that matches the number and structure of the lock seat grooves, and the locking wire is passed through the artificial implant and is gathered through the groove and protrusion structure of the lock seat. The control mechanism includes the lock seat, the locking wire, and the protrusion structure that matches the lock seat structure.

[0205] Referring to an embodiment, the lock seat 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 an embodiment, the lock rod 32 moves with the inner core 210 and has the following positions:

[0206] Lock position (see attached Figure 9 ), the locking rod 32 is inserted into the locking hole to constrain the locking wire 33;

[0207] Release position (see attached Figure 10 ), the locking rod 32 disengages from the locking hole to release the locking wire 33.

[0208] In one embodiment, the catheter assembly 200 further includes a wire control tube 220 movably sleeved outside the inner core 210, one end of the locking wire 33 is a driving end and connected to the wire control tube 220, and the other end of the locking wire is a working end. When the artificial implant is in a loaded state, the working end is wound around the artificial implant 100 and then cooperates with the locking rod 32. There are multiple locking wires 33.

[0209] like Figure 10 As shown, in one embodiment, the locking wire 33 has a developing mark 331, which is arranged at the distal end of the locking wire 33 and is made of developing metals such as platinum-iridium alloy and gold, so as to facilitate observation of the positional relationship between the locking wire 33 and the artificial implant 100, the locking seat 31 and the locking rod 32 during the operation, thereby achieving accurate release and recovery operations. The developing mark 331 is connected to the locking wire 33 by bonding, sewing, weaving, riveting and other processes, and the developing mark 331 has a solid or hollow structure, and can have different shapes, such as ring, filament, circle, square, etc., depending on the connection process.

[0210] In 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 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 recovered or released successfully, the sliding locking mechanism is unlocked, and the second handle slides proximally relative to the first handle to quickly retract the artificial implant and / or the control mechanism into the outer sheath and then withdraw it from the body.

[0211] Among them, as Figure 4 shown, the control of the catheter assembly and the corresponding drive mechanism is as follows:

[0212] The first support body 410 is provided with a first guide groove 4102, 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, a first support 419 is fixed inside 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 that is rotatably sleeved outside the first support body 410 and is threadedly engaged with the first base 491; a second extension sleeve 427 is fixed to the proximal end of the second support body 420, a second support 428 is fixed to the distal part 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 that are respectively threadedly engaged with the second base 492 and the third base 493.

[0213] The sheath 250 is fixed to the first support 419 inside 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 hermetically penetrated through the second support 428 and fixedly connected to the second base 492, and the inner core 210 is fixedly connected to the third base 493.

[0214] 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, the second exhaust structure 4291 is provided on the third support 429, and the third support 429 is connected to the second support 428 through an exhaust pipe 470, and the exhaust pipe 470 penetrates through the second support body 420.

[0215] Specifically, the first exhaust structure is used to exhaust the gas between the sheath and the outer sheath, and the second exhaust structure is used to exhaust the gas between the outer sheath and the inner sheath, between the inner sheath and the wire control tube, and between the wire control tube and the inner core.

[0216] In one embodiment, the control handle is provided with a window 404 corresponding to at least one base, which can be used to observe the relative position of the base. The window 404 can be embedded with a cover plate made of a transparent material for easy observation and protection. Preferably, the corresponding base is provided with a pointer, and the pointer is arranged close to the window 404 for easy observation by the operator. Further, the periphery of the window 404 can be provided with markings, such as scales or patterns. The second base 482 and the third base 492 are provided with pointers, among which as Figure 5As shown, the distal end of the display window corresponding to the second base 482 is marked with stent release, and the proximal end is marked with stent folding, so as to indicate the operation process. As Figure 4 、 Figure 5 and Figure 11 shown, the second support 420 includes:

[0217] A second main body 421, which is columnar and extends along the axial direction. Third sliding grooves 4211 extending along the axial direction are respectively provided on two radially opposite sides of the second support 420. Each strut 450 passes through the corresponding guiding hole 4222 and is placed in the corresponding third sliding groove 4211,

[0218] A second connecting seat 422, which includes two partition plates 4221 and a transition part 4223 connected between the two partition plates 4221. One of the partition plates 4221 is fixed to the distal end of the second main body 421;

[0219] A third connecting seat 423, which is fixed to the proximal end of the second main body 421.

[0220] The third sliding groove 4211 is opened on the back surface of the second main body 421, which is convenient for observing the assembly of the strut 450. And in view of the strip shape of the strut 450, the space occupied by the second main body 421 is reduced, ensuring the structural strength of the second main body 421. Among them, the second support 428 is installed inside the second connecting seat 422. The second main body 421 is provided with a groove 4213 forming a passage. The partition plate at the proximal end (i.e., the following second partition plate 4221b) is provided with an avoidance hole 4226. After the exhaust pipe 470 is connected to the conduit assembly, it extends out from the second support 428, passes through the open side of the transition part 4223 and then passes through the avoidance hole 4226 and the groove 4213 until it is connected to the third support 429. The groove 4213 is arranged on the outer wall of the second guiding groove 4212.

[0221] Referring to Figure 13 , in an embodiment, the two partition plates 4221 include a first partition plate 4221a at the distal end and a second partition plate 4221b at the proximal end. A cover plate 424 is buckled on the distal side of the first partition plate 4221a. The cover plate 424 is provided with an avoidance area 4241 corresponding to the positions of the installation channel 403 and the guiding hole 4222. Between the two partition plates 4221, that is, the transition part 4223 is generally a shell structure with a semi-cylindrical surface. The second support 420 further includes a second half shell 425 that is buckled and fixed to the transition part 4223 and encloses a cylindrical shape. Among them, the cover plate 424 is buckled and fixed to the first partition plate 4221a and the second half shell 425.

[0222] A positioning rib 4225 extending radially is provided on the distal side of the first partition plate 4221a, and the cover plate 424 is provided with a positioning groove 4242 that cooperates with the positioning rib 4225. The two partition plates 4221 extend open from their respective installation channel positions along the first radial direction X to their own edges, and the cover plate 424 extends open from the installation channel position along the second radial direction Y opposite to the first radial direction X to its own edge, and forms the positioning groove 4242.

[0223] Refer to Figure 3 , Figures 11 - 21 , in an embodiment, two support rods 450 are arranged side by side, and limiting members are arranged on the facing sides. The sliding locking mechanism cooperates with the limiting members to maintain the relative position of the second handle relative to the first support body. Once the cooperation between the two is released, the second handle is allowed to slide relative to the first support body. Among them, the limiting member is, for example, the positioning tooth 4502 provided in this embodiment. The support member in the second handle 42 includes a second support body 420. The second support body 420 is provided with a guiding hole 4222. The two support rods 450 extend into the corresponding guiding holes 4222. The second handle 42 is further 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 Figure 15 shown, in the unlocked state of the sliding locking mechanism 430, the second handle 42 is allowed to slide relative to the first handle 41 along the support rod 450; while as Figure 14 shown, in the locked state, the position of the second handle 42 relative to the first handle 41 is fixed.

[0224] The support rod serves both 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, satisfying the operation of the control handle and also simplifying the structure of the control handle.

[0225] Among them, the sliding locking mechanism 430 includes a locking member 431, an elastic member 432, and an operation button 433. The locking member 431 is movably installed on the second support body 420, and has a locking position that engages with the positioning tooth 4502 and an unlocking position that disengages from the positioning tooth 4502; the elastic member 432 (such as a spring) acts between the locking member 431 and the second support body 420 to drive the locking member 431 towards the locking position; the operation button 433 acts on the locking member 431 to drive the locking member 431 towards the unlocking position. The specific unlocking and locking operations are as follows: artificially applying a force to the operation button 433 and compressing the elastic member 432 to drive the locking member 431 to switch to the unlocking position; releasing the operation button 433, the elastic member 432 resets and acts on the locking member 431 to switch it to the locking position.

[0226] In an embodiment, the locking member 431 and the operation button 433 slide radially. The locking member 431 is provided with an assembly hole 4311, and the assembly hole 4311 is formed by grooving inside the locking member 431.

[0227] A sleeve sleeved on the support rod 450 slides through the assembly hole 4311. There is a movable gap 4312 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 locking member 431). The locking member 431 moves along the movable gap 4312 during the process of switching between the unlocking / locking positions. The specific movable gap 4312 is set such that the size of the assembly hole 4311 is larger than the thickness of the support rod 450 in the radial sliding direction of the locking member 431. Combining with the attached Figures 13 - 17 , in terms of assembly, the locking member 431 is sleeved on the support rod 450, which restricts the locking member 431 from disengaging from the second support body 420. By using different installation directions and the interactions between various components, additional limiting structures are omitted, the component structure is simplified, and the assembly is convenient.

[0228] In one embodiment, one side of the assembly hole 4311 faces the positioning tooth 4502, and an engaging portion 4313 that cooperates with the positioning tooth 4502 is provided on this side. The engaging portion 4313 is a tooth structure that cooperates with the positioning tooth 4502. Combining with the movement direction of the locking member 431, when the locking member 431 moves radially outward, it tends to the locking position, and when it moves radially inward, it tends to the unlocking position. Then, the engaging portion 4313 is arranged on the bottom side of the assembly hole 4311 (the facing direction of this side is radially outward). Among them, the cross-sectional shape of the positioning tooth 4502 is trapezoidal.

[0229] In one embodiment, the number of the positioning teeth 4502 is combined with the operation of the control handle as follows:

[0230] The number of the positioning teeth 4502 is one, which is used to keep the second handle at the position where the distance from the first handle is the farthest to achieve the closing of the proximal end of the seeker and the distal end of the outer sheath tube (i.e., the following second limit position);

[0231] The number of the positioning teeth 4502 is multiple and they are arranged at intervals along the axial direction. The second handle can be limited at multiple positions, which is used to adjust the position of the artificial implant in the body, or to adjust the covering distance of the outer sheath tube to the artificial implant when retrieving the artificial implant.

[0232] Among them, two sets of sliding locking mechanisms 430 are configured, which respectively act on the corresponding support rod 450. The operation buttons 433 in the two sets are arranged radially opposite and in opposite directions along the second handle 42. An abutting rib 4201 is fixed inside the second support body 420, and the elastic member 432 is pressed between the abutting rib 4201 and the locking member 431.

[0233] The control handle 400 is internally provided with an installation channel 403 that penetrates the first support body 410 along the axial direction. The abutting ribs 4201 in the two sets of sliding locking mechanisms are arranged at intervals and form a corresponding interval area 4202. As Figure 11 shown, the interval area 4202 allows the installation channel 403 to extend through.

[0234] In one embodiment, the locking member 431 is provided with an alignment seat 4315 on the side facing the elastic member 432, and the elastic member 432 is inserted into or sleeved on the alignment seat 4315. In the illustration, the elastic member 432 is a spring, and the alignment seat 4315 has a receiving cavity for receiving a part of the spring. After assembly, the elastic member 432 and the locking member 431 are blocked by the support rod 450 and will not come out of the second support body 420. Among them, two clamping plates 4203 are convexly arranged at intervals along the axial direction on the abutting rib 4201. An installation area 4204 that is adapted to the alignment seat 4315 and restricts the axial movement of the locking member 431 is formed between the two clamping plates 4203, and it plays a role in guiding the movement of the locking member 431.

[0235] In one embodiment, the support rod 450 is a metal strip. The radial cross-section of the metal strip along the control handle is strip-shaped and approximately rectangular, and the extending direction (length direction) in this cross-section is perpendicular to the interval arrangement direction of the two support rods 450.

[0236] In one embodiment, the support rod 450 includes a support strip 452 and a rack 453 with positioning teeth 4502, as Figure 12 shown. Among them, the support strip 452 is provided with an installation groove 4521 for installing the rack 453. The connection method between the rack 453 and the support strip 452 can be embedded or fixedly connected (such as bonding or welding, etc.). Among them, the installation groove 4521 opens towards the bottom side, and its extending range includes the sliding stroke of the second handle 42 relative to the first handle 41.

[0237] In one embodiment, the relationship between the positioning teeth 4502 and the bottom side of the support strip 452 is as follows:

[0238] The positioning teeth 4502 protrude from the bottom side of the support strip 452;

[0239] Or the positioning teeth 4502 are flush with the bottom side of the support strip 452;

[0240] Or the positioning teeth 4502 are lower than the bottom side of the support strip 452.

[0241] In one embodiment, the distal part of the second support body 420 is a second connecting seat 422, which includes two partition plates 4221 and a transition part 4223 connected between the two partition plates 4221;

[0242] The transition part 4223 is a shell structure with a semi-cylindrical surface as a whole. The second support body 420 further includes a second half shell 425 that is buckled and fixed with the transition part 4223 to enclose a cylindrical shape. The sliding locking mechanism 430 is located in the area surrounded by the transition part 4223 and the second half shell 425, and only a part of the operation button 433 is exposed for the operator to operate.

[0243] Refer to Figure 16 andFigure 18 , in one embodiment, the operating button 433 and the locking member 431 are snap-fitted and fixed. There is a clamping post provided on one of them and a clamping hole provided on the other and mating with the clamping post. For example, in the illustrated figure, the clamping post 4331 protrudes from the operating button 433; the clamping hole 4314 is provided on the locking member 431 and is in a tight fit with the clamping post 4331. There are two clamping posts 4331.

[0244] Refer to Figure 20 and Figure 21 , in one embodiment, the second support body 420 further includes a clamping seat 426 clamped between the second connecting seat 422 and the second half shell 425. The clamping seat 426 has an open slot 4261 for the operating button 433 to be exposed. The clamping seat 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.

[0245] Among them, the open slot 4261 is circumferentially closed, and the slot wall of the open slot extends along the movement direction of the operating button 433 to provide a movement guide for the operating button 433.

[0246] Refer to Figure 2 and Figures 23 - 38 , the rotation locking mechanism 460 includes a first pipe fitting 461, a second pipe fitting 462 and a locking member 463. It should be noted that the first pipe fitting 461 and the second pipe fitting 462 do not belong to the catheter assembly 200. The first pipe fitting 461 is fixed to the support body. The fixing method is, for example, separately connected and fixed inside the handle or integrally formed with the support body as a part of the support body. Taking the first support body 410 as an example in the illustrated figure, and the first pipe fitting 461 is a part of the first support body 410. A part of the installation channel 403 extends through the inside of the first pipe fitting 461, that is, the first pipe fitting 461 is a hollow structure for part or all of the catheter assembly 200 to pass through.

[0247] The second pipe fitting 462 is rotatably sleeved on the outer circumference of the first pipe fitting 461. A part of the second pipe fitting 462 is a working section 4621 extending into the rotating member 480. The outer wall of the working section 4621 has a protrusion 4622. Both the first pipe fitting 461 and the second pipe fitting 462 extend along the axial direction of the control handle. They are not strictly restricted to be circumferentially closed, and can also be partially open in the circumferential direction. In addition, the cross-sectional shapes of the two are not strictly restricted.

[0248] The locking member 463 is located in the radial clearance between the working section 4621 and the rotating member 480, and is configured to be able to slide radially along the rotating member 480 and act on the inner wall of the rotating member 480. During the rotation of the second pipe fitting 462, the locking member 463 is pressed by the protruding portion 4622 to move and correspondingly lock the rotating member 480, or the protruding portion 4622 releases the pressing on the locking member 463 to release the locking of the rotating member 480. The protruding direction of the protruding portion 4622 includes at least the radial direction.

[0249] As Figure 29 , when in the unlocked position, there is a clearance between the locking member 463 and the inner wall of the rotating member 480, thus allowing the rotating member 480 to rotate easily under manual action; as Figure 30 , when the second pipe fitting 462 rotates around the dotted line to the locking position, the locking member 463 moves in the arrow direction and abuts against the rotating member 480, so that a sufficient large acting force (such as static friction force) is generated between the two, thereby restricting the rotation of the rotating member 480. The structure of this device can lock the rotating member 480 to any position, which is beneficial to the control of the artificial implant. Compared with the existing locking structure, the operation precision of the control handle is improved, and the locking operation is completed in one step, simplifying the operation steps. In addition, the locking member is installed in the radial clearance between the working section and the rotating member, making the appearance of the control handle simple. The overall shape structure is convenient for holding and operating, effectively utilizing the space and making the structure of the control handle more compact.

[0250] In this embodiment, the rotary locking mechanism 460 further includes an operating member 464 for driving the second pipe fitting 462 to rotate. The operating member 464 is movably arranged on the first support body 410, and it can be:

[0251] a. Separately connected;

[0252] b. Integrally formed. For example, the second pipe fitting 462 and the operating member 464 are integrally formed. One section of the second pipe fitting 462 along the axial direction is the working section 4621, and the other section is connected with the operating member 464;

[0253] c. Mutually independent, and the two are linked and cooperated with each other through a transmission member.

[0254] Among them, the second pipe fitting 462 has opposite:

[0255] Locking position, the protruding portion 4622 abuts tightly against the locking member 463 and acts on the rotating member 480 to generate a tightening force on it;

[0256] Release position, the protruding portion 4622 releases the tightening force on the locking member 463.

[0257] As Figures 22 - 24, in one embodiment, the side walls of the first support 410 and the first pipe fitting 461 are partially open towards the same side in the radial direction to form an installation opening 4611, and the installation opening 4611 communicates with the installation channel 403, facilitating the installation of the catheter assembly 200 and the base.

[0258] In one embodiment, the side wall of the second pipe fitting 462 is open towards one side in the radial direction, and the open position is circumferentially offset from the open position of the first pipe fitting 461. The one-side opening of the second pipe fitting 462 allows its working section 4621 to have a certain deformation ability in the radial direction. For example, when locked, the inner wall of the working section 4621 abuts against the outer wall of the first pipe fitting 461, and the working section 4621 itself is subjected to forces in two directions, namely, the inner side and the outer side in the radial direction, thereby restricting the rotation of the second pipe fitting 462; when unlocking, a relatively large driving force needs to be applied to the operating member, thus avoiding accidental unlocking and improving safety.

[0259] Among them, the circumferential offset distribution of the open position of the second pipe fitting 462 from the open position of the first pipe fitting 461 is understood as: taking Figure 29 the unlocking position as an example, during the rotation of the second pipe fitting 462, the opening 4623 of the second pipe fitting 462 does not coincide with the installation opening 4611.

[0260] Refer back to Figures 23 - 27 , in one embodiment, the first support 410 includes a first main body 411 and a first connection seat 412. The first main body 411 is columnar and extends along the axial direction of the control handle, and the first pipe fitting 461 is located on the proximal side of the first main body 411; the first connection seat 412 is fixed to the proximal end of the first main body 411 and there is a radial gap between the first connection seat 412 and the first pipe fitting 461, and the radial position of the second pipe fitting 462 is located in the radial gap. Among them, the first connection seat 412 is generally a shell structure with a semi-cylindrical surface, and the first support 410 further includes a first half shell 414 that is snap-fitted and fixed to the first connection seat 412 to enclose a cylindrical shape. The first half shell 414 is provided with an avoidance window 4181, and the operating member 464 is exposed in the avoidance window 4181. The operating member 464 is provided with an anti-slip portion 4641 and an indicator 4642 for indicating locking and unlocking.

[0261] Regarding the setting of the locking member, it is as follows:

[0262] Such as Figure 31 and Figure 32, in one embodiment, the first connection seat 412 is provided with a guiding groove 4121 that penetrates radially. The locking member includes a first locking member 4631 (such as a block) that is slidably arranged in the guiding groove 4121 in the radial direction. A convex portion 4622 on the second pipe fitting 462 abuts against the inner side in the radial direction of the first locking member 4631. Among them, the outer contour of the working section 4621 of the second pipe fitting 462 is circular, and the convex portion 4622 extends along the rotation direction of locking (hereinafter referred to as the first direction). The outer surface height of the convex portion 4622 gradually increases along the first direction. The inner wall of the locking member is an arc surface that matches the outer contour of the convex portion 4622.

[0263] Based on the mutually matching shape structures of the above-mentioned locking member 463 and the convex portion 4622, the wall of the guiding groove 4121 is provided with a registration structure that cooperates with the first locking member 4631. This registration structure prevents the wrong installation of the first locking member 4631 and positions the position of the first locking member 4631 relative to the guiding groove 4121. The registration structure includes:

[0264] A positioning groove 4122, which is provided on one of the wall of the guiding groove 4121 or the first locking member 4631;

[0265] A positioning block 4632, which is provided on the other of the wall of the guiding groove 4121 or the first locking member 4631 and cooperates with the positioning groove 4122. Among them, the positioning groove 4122 is a flared structure.

[0266] Such as Figure 30 、 Figure 33 And Figure 34 , in another embodiment, there can be multiple locking members 463 in the circumferential direction. For example, it includes a first locking member and a second locking member 4635. The second locking member 4635 is movably buckled with the first connection seat 412 in the radial direction. The first locking member 4631 and the second locking member 4635 move synchronously and in opposite directions, respectively acting on the inner walls at different radial positions of the same rotating member 480 to improve the locking strength.

[0267] Among them, the second locking member 4635 is semi-circular and there is a mutually matching guiding structure between it and the first support body 410.

[0268] Such as Figure 30 As shown, the guiding structure includes:

[0269] A first slider 4633, which is provided on one of the first connection seat 412 or the second locking member 4635;

[0270] A first sliding groove 4123, which is provided on the other of the first connection seat 412 or the second locking member 4635 and cooperates with the first slider 4633.

[0271] Such as Figure 33 AndFigure 34 As shown, in another embodiment, the guiding structure further includes:

[0272] A second sliding groove 4101, disposed on the first main body 411;

[0273] A second sliding block 4639, disposed on the second locking member 4635 and cooperating with the second sliding groove 4101.

[0274] Refer back to Figure 29 and Figure 30 , in one embodiment, the first locking member 4631 and the second locking member 4635 are axially in the same position and are on two opposite sides in the radial direction of the second pipe fitting 462. In another embodiment, there are a plurality of locking members 463 arranged axially, for example, a plurality of locking members act on different axial positions of the same rotating member.

[0275] Wherein, a stop member 4643 is embedded at the position where the locking member 463 cooperates with the rotating member 480. Combining the foregoing, stop members 4643 are embedded in both the first locking member 4631 and the second locking member 4635, as Figure 23 shown. The first locking member 4631 and the second locking member 4635 are made of hard materials and can stably slide after being adapted to the first connecting seat 412. The stop member 4643 is made of soft material, has a relatively high friction coefficient and has a certain amount of deformation, such as rubber. When locking, the stop member 4643 is squeezed against the inner wall of the rotating member 480, thereby increasing the static friction force.

[0276] 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 foregoing guiding structure, and at least there is always a gap between the second locking member 4635 and the inner wall of the rotating member 480, so that when in the unlocking position, the rotating member 480 can rotate smoothly.

[0277] Wherein the inner wall of the second locking member 4635 is a radially undulating structure, and the radially undulating structure includes an arc surface 4638 (centered on the axis of the control handle), and an avoidance area 4637 that is radially recessed to avoid the protruding portion 4622 at the unlocking position. As Figure 29 , when in the unlocking position, a section with a relatively high radial protrusion height of the protruding portion 4622 is located in the avoidance area 4637, as Figure 30 , when in the locking position, this section abuts against the arc surface 4638 and drives the second locking member 4635 to slide radially outward.

[0278] As Figures 35 - 37, in an embodiment, the first connecting seat 412 has a blocking portion 4124 that abuts against the operating member 464 to limit its rotation amplitude. In the illustrated figure, there are two blocking portions 4124 and they are in a sheet structure. The operating member 464 abuts against one of the blocking portions 4124 at the locked position and the unlocked position respectively.

[0279] In an embodiment, a partial area of the first support body 410 is radially penetrated to form a first guiding groove 4102. A base (such as the first base 491) is slidably disposed in the first guiding groove 4102. The base is used to connect a controlled component (such as the catheter assembly 200); the rotating member 480 is a driving sleeve. The driving sleeve is rotatably sleeved on the outer periphery of the first support body 410. A threaded transmission fit is provided between the inner wall of the driving sleeve and the base. Then, the aforementioned stop member 4643 can better adapt to the threaded structure of the driving sleeve.

[0280] Regarding the rotation locking mechanism, the rotation locking mechanism has nothing to do with the number of handles. For example, the control handle 400 includes one handle, and a rotation locking mechanism is provided on the handle.

[0281] In an embodiment, two connecting sleeves 440 are fixedly connected to the proximal part of the first support body 410. The distal parts of the respective support rods 450 are fixedly inserted into the corresponding connecting sleeves 440. The fixing manner between the two can be snap connection or connection through fasteners.

[0282] The support member of the second handle 42 includes a second support body 420. The distal part of the second support body 420 includes two partition plates 4221 arranged at intervals along the axial direction. A guiding hole 4222 is formed on each partition plate 4221. Third sliding grooves 4211 extending along the axial direction are respectively provided on the two radially opposite sides of the second support body 420. Each support rod 450 passes through the corresponding guiding hole 4222 and is placed in the corresponding third sliding 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 limit positions of approaching / leaving the first handle 41, which are respectively Figure 2 the first limit position where the second handle 42 abuts against the first handle 41 as shown, and Figure 3 the second limit position where the second handle 42 is away from the first handle 41 as shown.

[0283] The support rod is rod-shaped, which is convenient for processing and has a lower processing cost; and more optional materials are available. For example, hard metal can be used to improve the structural strength of the support member of the first handle and improve the connection stability between the first handle and the second handle, that is, the support rod is not easily bent or broken when the second handle is away from the first handle.

[0284] In addition, in order to ensure the sliding stability of the second handle, two support rods are provided. In view of the structural shape of the support rods, their cross-sectional shapes are small, occupying less space and facilitating arrangement in the space inside the second handle.

[0285] Among them, the control handle 400 is provided with an installation channel 403 that axially penetrates the first support body 410 and the second support body 420. The installation channel 403 allows the catheter assembly 200 to pass through. The first support body 410 includes a first main body 411 and a first connection seat 412. The first main body 411 is columnar and extends axially. The first connection seat 412 is fixed to the proximal end of the first main body 411. Two connection sleeves 440 are fixed to the first connection seat 412 and are located on both sides of the installation channel 403 in the radial direction. Specifically, the connection sleeve 440 is integrally formed with the first main body 411 and the proximal end is open for the support rod 450 to be inserted.

[0286] The connection between the support rod 450 and the connection sleeve 440 is as follows:

[0287] As Figure 12 、 Figure 35 and Figure 38 shown, the side wall (outer side in the radial direction) of the connection sleeve 440 and the distal end of the support rod 450 are provided with positioning holes 441 corresponding in position, and are fixedly connected by a connecting member 442 passing through the positioning holes 441. For example, the connecting member 442 is a screw, and the support rod 450 is provided with a threaded hole for cooperating with the screw.

[0288] As Figure 35 and Figure 39 shown, in an embodiment, the first connection seat 412 is generally a housing structure with a semi-cylindrical surface. The housing structure, as part of the outer shell, can be held. The first support body 410 further includes a first half shell 414 that is snap-fitted and fixed to the first connection seat 412 and encloses a cylindrical shape with the housing structure. Among them, the connection sleeve 440 is located at the junction of the first connection seat 412 and the first half shell 414, and the outer wall of the connection sleeve 440 is provided with a buckle 415 that cooperates with the first half shell 414.

[0289] In a preferred embodiment, the installation direction of the first half shell 414 is radial, and the inner wall of the first half shell 414 is provided with a limiting rib 416 that abuts against the connection 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 connection sleeve 440 along the axial direction of the control handle.

[0290] Part of the structure of the first support body 410 also serves as part of the outer shell, saving manufacturing costs and simplifying the connection method with the outer shell.

[0291] Refer back to Figure 24 and Figure 35, in one embodiment, the first connecting seat 412 is arranged on the side opposite to the notch of the first guiding groove 4102, and the connection line of the two connecting sleeves 440 is arranged at 90 degrees to the notch direction.

[0292] As Figure 40 and Figure 41 shown, in one embodiment, the proximal part of the third sliding groove 4211 is the end segment extending to the outer periphery of the third connecting seat 423, and a mutually matching engaging structure is provided between the groove wall of the end segment and the support rod 450. Specifically, the engaging structure includes:

[0293] a clamping block 4231, protruding from the groove wall of the third sliding groove 4211;

[0294] a clamping groove 4501, arranged on the support rod 450 and cooperating with the clamping block 4231. When the second handle 42 is in the first extreme position, the clamping block 4231 and the clamping groove 4501 cooperate with each other, that is, the clamping groove 4501 is adjacent to the proximal end of the support rod 450. This engaging structure only provides a certain damping. After the sliding locking mechanism is unlocked, applying a certain external force to the second handle can release the cooperation between the engaging structures. This engaging structure avoids the accidental unlocking of the sliding locking mechanism by the operator, resulting in the sliding of the second handle, and improves the use safety.

[0295] As Figure 42 and Figure 43 shown, in one embodiment, an anti - detachment member 451 is provided at the proximal part of the support rod 450. When the second handle slides proximally relative to the first handle to the extreme position (i.e., the second extreme position), the anti - detachment member 451 is blocked by the partition plate. The anti - detachment member 451 can be integrally formed with the support rod 450 or fixedly connected in a separated manner. For example, the anti - detachment member 451 is a screw, and the screw includes a screw rod 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 plate 4221b. During assembly, first insert the support rod 450 through the second partition plate 4221b, and then install the anti - detachment member 451.

[0296] Refer to Figure 44 and Figure 45, the present application also provides an artificial implant 100, which has a stent 110 with a grid structure 111 and in a cylindrical shape. Inside the stent 110 is a blood flow channel 150. A plurality of valve leaflets 120 inside the stent cooperate with each other in the blood flow channel to relatively open or close the blood flow channel 150. The stent 110 has a corresponding axial direction (axis 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 side wall with a hollowed-out area. The edges of the hollowed-out area are the frame bars that enclose the grid, and there are no strict limitations on the size and specific shape of the grid. In the axial direction of the stent, they are respectively an inflow side 112 and an opposite outflow side according to the normal blood flow direction in the body. The stent itself can be processed by cutting or weaving a pipe, and corresponding materials are used according to the release method in the body (such as self-expanding or balloon-expandable).

[0297] Among them, the artificial implant 100 further includes an inner lining membrane 140 that is connected to the stent 110 and is located in the blood flow channel. The inner lining membrane 140 is generally connected to the corresponding frame bars of the stent position by sewing. The outflow side of the inner lining membrane 140 is joined with the inflow side of each valve leaflet 120, and the joining method is, for example, sewing, etc. The artificial implant 100 further includes a plurality of anti-peripheral leakage components 130. The plurality of anti-peripheral leakage components 130 are arranged along the circumferential direction of the stent 110 and are embedded in the grid structure 111 at the corresponding positions. The plurality of anti-peripheral leakage components 130 surround and close along the circumferential direction of the stent 110. All the grid structures in the same layer are filled and embedded by the anti-peripheral leakage components 130. The anti-peripheral leakage components protrude outward from the corresponding grid structure and are used to interact with the surrounding tissues in the body to prevent blood flow from passing through the periphery of the artificial implant. The anti-peripheral leakage component 130 is connected to the inner lining membrane 140, and at least one of bonding, heat fusion, sewing, infiltration, or dip coating is used to fix them. In the delivery system of the present application, the strut not only serves as a connecting member between the second handle and the first handle, but also can improve the structural strength of the control handle, cooperate with the sliding locking mechanism to maintain the length dimension of the control handle and meet the operation requirements, such as the rapid retraction of the artificial implant and the precise control of the artificial implant during recovery.

[0298] The technical features of the above embodiments can be combined arbitrarily. For the sake of concise description, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combinations of these technical features do not conflict, they should all be considered as within the scope described in this specification. When the technical features in different embodiments are shown in the same drawing, it can be regarded that the drawing also discloses the combined examples of the respective embodiments involved at the same time.

[0299] The above embodiments merely represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation to the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all fall within the protection scope of the present application.

Claims

1. A delivery system for an artificial implant that is conveniently controlled, having a distal end and a proximal end that are opposite, characterized in that: The delivery system comprises a control handle and a catheter assembly whose proximal end is connected to the control handle, the catheter assembly comprises an outer sheath and an inner shaft assembly located inside the outer sheath, the artificial implant is connected to the distal end of the inner shaft assembly and is controlled by the control handle, and the control handle comprises a support member and a driving mechanism disposed on the support member; The support body is provided with a guide groove extending axially, 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, and a threaded transmission is provided between the driving sleeve and the base. The support body is provided with a rotation locking mechanism in its own guide groove which can limit or allow the rotation of the driving sleeve.

2. The conveniently controlled artificial implant delivery system according to claim 1, characterized in that: The rotation locking mechanism is arranged at the proximal side of the guide groove, the drive sleeve is a cylindrical structure and has an inner wall and an outer wall opposite to each other, and the rotation locking mechanism comprises: A first pipe member is fixed to the support body, the control handle has a mounting channel axially penetrating the support body, and a portion of the mounting channel extends through the first pipe member; A second pipe member, the rotating sleeve of which is arranged on the outer periphery of the first pipe member, wherein a part of the second pipe member is a working section extending into the driving sleeve, and an outer wall of the working section has a convex portion; A locking member is located in a radial gap between the working section and the driving sleeve and is configured to be able to slide along the radial direction of the driving sleeve and act on the inner wall of the driving sleeve. During the rotation of the second pipe member, the locking member is pressed by the protruding portion to move and lock the driving sleeve accordingly; The operating component drives the second pipe to rotate.

3. The conveniently controlled artificial implant delivery system according to claim 2, characterized in that: The side walls of the support body and the first pipe are partially opened toward the same radial side to form a mounting opening.

4. The conveniently controlled artificial implant delivery system according to claim 3, characterized in that: The side wall of the second pipe is open toward one side in the radial direction, and the opening position is staggered with the opening position of the first pipe in the circumferential direction.

5. The conveniently controlled artificial implant delivery system according to claim 2, characterized in that: The support body comprises: The main body is columnar and extends axially along the control handle, and the first tube is located at the proximal side of the main body; The connecting seat is fixed to the proximal end of the main body and has a radial gap with the first pipe member, and the radial position of the second pipe member is located in the radial gap.

6. The conveniently controlled artificial implant delivery system according to claim 5, characterized in that: The connecting seat is provided with a radially through guide groove, the locking member includes a first locking member slidably arranged in the guide groove, the protrusion on the second tube member abuts against the radial inner side of the first locking member, and the groove wall of the guide groove is provided with a matching structure that cooperates with the first locking member.

7. The conveniently controlled artificial implant delivery system according to claim 2, characterized in that: The locking member comprises: A first locking member, slidably embedded in the connecting seat; 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.

8. The conveniently controlled artificial implant delivery system according to claim 3, characterized in that: The height of the outer surface of the protrusion gradually increases along the circumference of the second pipe.

9. The conveniently controlled artificial implant delivery system according to claim 3, characterized in that: The second pipe member has relative: In the locking position, the protrusion is pressed against the locking member and acts on the driving sleeve; A release position, wherein the protrusion and the locking member release the pressing force; The locking element has an arc surface or a radial undulating structure matched with the protruding portion.

10. The conveniently controlled artificial implant delivery system according to claim 1, characterized in that: The control handle includes a first handle and a second handle that cooperate with each other, and 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 distal end of the third shaft is connected to a lock seat, and the lock seat has a lock hole or a groove; The distal end of the second shaft is connected with a locking wire, and the locking wire is used to pass through the artificial implant and then be connected to the locking seat to restrain or release the artificial implant; 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 locking seat.

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