CN110638490A

CN110638490A - Lockable implant pusher and implant delivery system

Info

Publication number: CN110638490A
Application number: CN201810674330.7A
Authority: CN
Inventors: 张庭超; 李阳; 徐澧
Original assignee: Hangzhou Strong Medical Technology Co Ltd
Current assignee: Hangzhou Strong Medical Technology Co Ltd
Priority date: 2018-06-26
Filing date: 2018-06-26
Publication date: 2020-01-03
Also published as: WO2020001173A1

Abstract

The invention discloses a lockable implant pushing device and an implant conveying system. The pushing device comprises a pushing assembly and a handle assembly connected with the near end of the pushing assembly, the pushing assembly comprises a hollow pushing steel cable, an inner core movably arranged in the pushing steel cable in a penetrating mode, and a clamping piece arranged at the far end of the inner core and detachably connected with the implant; the holder includes two at least centre gripping arms, and at least one centre gripping arm distal end is equipped with the hook piece, and the hook piece extends or deviates from the axis direction extension of propelling movement steel cable towards the axis direction of propelling movement steel cable, and the extending direction of a plurality of hook pieces is different. The invention has reliable connection with the implant, prevents the implant from being disconnected before reaching the appointed part, and can be disconnected only by one-hand operation to release the implant.

Description

Lockable implant pusher and implant delivery system

Technical Field

The invention belongs to the technical field of medical instruments, and relates to a lockable implant pushing device and an implant conveying system.

Background

In recent years, interventional therapy has been widely used in clinical applications. Interventional therapy refers to the treatment of cardiovascular diseases by placing various materials, instruments and the like on the heart, artery, vein vessel and other parts of a human body through a catheter technology. For example, a Vena Cava Filter (VCF) is placed in the upper and lower vena cava of a patient by a catheter intervention method, and the fallen thrombus is captured to prevent the thrombus from moving to the heart and lung along the vena cava system to cause pulmonary artery embolism; or a left atrial appendage occluder is delivered into the left atrial appendage to prevent thrombus generated by atrial fibrillation from ascending to the brain, causing stroke or other systemic embolism. Implantation of such devices requires a delivery system to deliver the implant to various parts of the body and then to disengage the pusher from the implant. The connection mode of the existing pushing device and the implant is mainly threaded connection or connection only by the friction force of the implant. The main disadvantages of these types of pushing devices and conveying systems are: firstly, the structure is complex, the pushing device and the implant need to directly and relatively rotate in the conveying process or the releasing process, and the rotating process is uncontrollable, so that the operation is inconvenient; secondly, in a bent human blood vessel, when the blood is washed or the inner wall of the bent blood vessel is rubbed, the friction force is too large or too small, so that the implant is blocked, or the implant is released in advance due to the connection failure, so that the operation failure is caused.

Disclosure of Invention

The present invention is directed to a lockable implant pushing device, which has a reliable connection locking force with an implant to prevent the implant from being released before reaching a designated location.

Another object of the present invention is to provide an implant delivery system, which is reliably connected to an implant, prevents the implant from being detached before reaching a desired site, and can be operated with a single hand without rotating a pushing device.

The technical scheme adopted by the invention for solving the technical problems is as follows:

an implant pushing device comprises a pushing assembly and a handle assembly connected with the near end of the pushing assembly, wherein the pushing assembly comprises a hollow pushing steel cable, an inner core movably arranged in the pushing steel cable in a penetrating mode, and a clamping piece arranged at the far end of the inner core and detachably connected with an implant; the holder includes two at least centre gripping arms, at least one the centre gripping arm distal end is equipped with the hook, the hook orientation the axis direction of propelling movement steel cable extends or deviates from the axis direction of propelling movement steel cable extends, and is a plurality of the extending direction of hook is different.

Further, the planes of the ends of at least two of the hooks do not overlap.

Furthermore, the clamping piece has a free state and a locking state, when the clamping piece is in the free state, the far ends of the clamping arms extend out of the far ends of the push steel cables, and the far ends of all the clamping arms are respectively radially expanded in different directions along the radial direction; when the clamping pieces are in a locking state, all the clamping arms retract towards the pushing steel cable and are folded towards the central axis of the pushing steel cable, and at least one of the hook pieces is connected with the clamping arms or staggered with the clamping arms to form an annular closed structure, or at least two of the hook pieces are connected with each other or staggered with the clamping arms to form an annular closed structure.

Further, in a free state, an included angle between the at least one clamping arm and the central axis of the pushing steel cable ranges from 90 degrees to 150 degrees or from 200 degrees to 270 degrees, and included angles between the two clamping arms forming the annular closed structure and the central axis of the pushing steel cable are not equal.

Furthermore, the far end of the pushing steel cable is provided with a limiting part, the limiting part is provided with a limiting hole along the axial direction of the pushing steel cable, when the clamping piece is in a free state, the hook piece and the far end of the clamping arm extend out of the limiting hole, when the clamping piece is in a locking state, the hook piece is positioned outside the limiting hole, and the far end part of the clamping arm, which is connected with the near end of the hook piece, is folded together in the limiting hole.

Further, the long axis dimension of the limiting hole is larger than the outermost side of each clamping arm of the clamping piece in the locking state on a plane perpendicular to the axial direction of the inner core, and is smaller than the dimension of each hook piece of the clamping piece in the locking state on the plane perpendicular to the axial direction of the inner core; the minor axis of the limiting hole is approximately equal to the sum of the sizes of the proximal end parts of the clamping arms on a plane perpendicular to the axial direction of the inner core.

Further, the handle assembly includes a handle and an axial drive control mechanism disposed on the handle that moves axially relative to the handle to drive axial relative movement between the push cable and the inner core.

Furthermore, a control groove is formed in the handle in the axial direction, and the axial driving control mechanism moves in the control groove in the axial direction.

Furthermore, the handle assembly further comprises an elastic piece arranged at the near end or the far end of the axial driving control mechanism, and the compression or the reset of the elastic piece drives the axial movement of the axial driving control mechanism so as to drive the axial relative movement between the pushing steel cable and the inner core.

Further, the far end of the axial driving control mechanism is connected with the pushing steel cable, and the near end of the axial driving control mechanism is connected with the elastic piece.

Furthermore, the handle is also provided with at least two clamping positions which are radially deviated relative to the control groove and communicated with the control groove, and the axial drive control mechanism moves in the control groove and the clamping positions.

Further, the screens include the first screens that are located distal end and the second screens that are located the near-end, when axial drive control mechanism switches in the first screens and in the second screens, the holder is in locking state and free state transition.

Further, the axial driving control mechanism is connected with the pushing steel cable, and when the axial driving control mechanism is located in the first clamping position, the clamping piece is in a locking state; when the axial drive control mechanism is positioned in the second clamping position, the clamping piece is in a free state.

An implant delivery system comprises the implant pushing device and an outer sheath tube with a certain axial length, wherein the implant pushing device is movably arranged in the outer sheath tube in a penetrating mode and is detachably connected with the proximal end of the outer sheath tube.

Further, the implant delivery system also comprises an expansion device, the expansion device is movably arranged in the sheath tube in a penetrating mode, and the proximal end of the expansion device is detachably connected with the proximal end of the sheath tube.

Further, the implant delivery system further comprises a loading device removably attached between the outer sheath proximal end and the pusher distal end.

Further, the implant delivery system further includes a hemostatic device removably coupled between the loading device and the pusher device distal end.

Further, at least one of the sheath tube, the loading device and the hemostatic device is provided with an elastic sealing element, and the elastic sealing element is provided with at least one aperture along the axial direction of the pushing device.

Further, a proximal end of the resilient seal member forms a first slit, a distal end of the resilient seal member forms a second slit, a sum of thicknesses of the first slit and the second slit is equal to a thickness of the resilient seal member, directions of the first slit and the second slit are different, and a projection of the first slit on a distal surface of the resilient seal member intersects a projection of the second slit on the distal surface of the resilient seal member.

Further, a projection of the first slit on the distal surface of the resilient seal is perpendicular to a projection of the second slit on the distal surface of the resilient seal.

Compared with the prior art, the invention at least has the following beneficial effects:

the hook members of the implant pushing device are connected or overlapped in a staggered way to form an annular closed structure, and the connection between the hook members and the implant can be locked to prevent the implant from being released before reaching a designated part; moreover, the opening state of the clamping piece and the size of the locking force can be adjusted according to different implant types and requirements of the implants on the connecting force of the pushing device, and the application range is wide.

When the implant is released, an operator does not need to rotate the pushing device, only needs to operate the axial driving control mechanism and the elastic piece on the handle with one hand, and can quickly release the implant by compressing or resetting the elastic piece to drive the axial movement of the axial driving control mechanism, so that the operation is convenient and simple. Or an operator operates the axial driving control mechanism on the handle with one hand to control the axial driving control mechanism to move in the control groove and the clamping position, so that the implant can be quickly released, and the operation is convenient and simple.

Drawings

The invention will be further described with reference to the accompanying drawings and examples, in which:

FIG. 1 is a partial cross-sectional view of an implant pusher device according to a first embodiment of the invention, the implant pusher device including a pusher assembly and a handle assembly;

FIG. 2 is an exploded view of the pusher assembly of FIG. 1, including the pusher cable, inner core, retaining member and retainer;

FIG. 3 is a schematic view of the structure of the clamp of FIG. 1;

FIGS. 4a-4d are schematic structural views of different embodiments of a clamp;

FIGS. 5a-5b are schematic views of the clamp of FIG. 1 in different states, wherein FIG. 5a shows the clamp in a free state and FIG. 5b shows the clamp in a locked state;

FIG. 6 is a schematic structural diagram of the limiting member in FIG. 1;

FIG. 7 is a schematic view of the connection between the holder and the implant of FIG. 1;

FIG. 8 is a cross-sectional view of the handle assembly of FIG. 1;

FIG. 9 is a schematic structural view of a clamping member of the implant pushing device according to the second embodiment of the present invention;

FIG. 10 is a schematic view of the clamp of FIG. 9 in a free state;

FIG. 11 is a schematic view of the clamp of FIG. 9 in a locked condition;

FIG. 12 is a schematic structural view of a clamping member of the implant pushing device according to the third embodiment of the present invention;

FIG. 13 is a schematic view of the clamp of FIG. 12 in a free state;

FIG. 14 is a schematic view of the clamp of FIG. 12 in a locked condition;

fig. 15 is a schematic structural view of an implant pushing device according to a fourth embodiment of the present invention;

FIGS. 16a and 16b are partial cross-sectional views of FIG. 15, wherein FIG. 16a shows the clamp in a free state and FIG. 16b shows the clamp in a locked state;

FIG. 17 is an exploded view of the handle assembly of FIG. 15;

FIG. 18 is a partial cross-sectional view of an implant pushing device according to a fifth embodiment of the present invention;

FIG. 19 is an exploded view of the handle assembly of FIG. 18;

FIG. 20 is a schematic structural view of an implant delivery system according to a sixth embodiment of the present invention, the implant delivery system including an implant pushing device, a dilation device, a loading device, a hemostasis device, and a sheath;

FIG. 21 is a schematic view of the outer sheath and expansion device of FIG. 20 assembled together;

FIG. 22 is a schematic view of the loading device, hemostatic device, and pusher device of FIG. 20 assembled together;

FIG. 23 is a schematic view of the outer sheath, loading device, hemostatic device, and pusher device of FIG. 20 assembled together;

FIG. 24 is a schematic structural view of the outer sheath of FIG. 20;

FIG. 25 is a partial cross-sectional view of the sheath hub of FIG. 24;

FIG. 26 is a schematic view of the elastomeric seal of FIG. 25;

FIG. 27a is a cross-sectional view taken along B-B of FIG. 26;

fig. 27b is a cross-sectional view along C-C of fig. 26.

FIG. 28 is a schematic structural view of the stent of FIG. 20;

FIG. 29 is a schematic view of the structure of the loading device of FIG. 20;

fig. 30 is a schematic view of the hemostatic device of fig. 20.

Detailed Description

For a more clear understanding of the technical features, objects and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

Orientation definition: in the field of interventional medicine, it is common to refer to the end closer to the operator as the "proximal end" and the end farther from the operator as the "distal end" during the surgical procedure.

Example one

Referring to fig. 1 to 7, the implant pushing device 10 of the first embodiment is used for pushing and releasing an implant 200 to a predetermined position in a patient. Implant 200 includes, but is not limited to, a vascular filter, a vascular stent, a heart valve clamp, a heart defect occluder, a vascular plug, or a lung volume-reducing elastomer. The implant 200 is made of a material having a shape memory function, and can be stretched into a string shape and loaded into a hollow tube body in use. The proximal end of the implant 200 is provided with an attachment portion, typically a curved retrieval hook or at least one through hole, for removable attachment to the implant pusher 10. In this embodiment, the implant 200 is an inferior vena cava filter, the proximal end of the inferior vena cava filter is provided with a curved retrieval hook, and the implant pushing device 10 delivers and releases the inferior vena cava filter to the inferior vena cava of the patient.

The implant pusher 10 includes a pusher assembly 1000 and a handle assembly 2000 coupled to a proximal end of the pusher assembly 1000. Referring to fig. 2 and 3, the pushing assembly 1000 includes a hollow pushing wire cable 1100, a core 1200 movably disposed in the pushing wire cable 1100, and a holder 1300 disposed at a distal end of the core 1200 and detachably connected to the implant 200. Referring to fig. 4a-4d, clamp 1300 includes at least two clamp arms 1320, at least one clamp arm 1320 having a hook 1310 disposed at a distal end thereof. The hook 1310 extends towards the central axis of the push cable 1100 or extends away from the central axis of the push cable 1100, the extending directions of the hook 1310 are different, and the planes of at least two hooks 1310 are not overlapped.

Referring to fig. 5a and 5b, the clamp 1300 has a free state and a locked state. When the holding member 1300 is in a free state, the distal ends of the holding arms 1320 extend out of the distal end of the push wire cable 1100, and the distal ends of all the holding arms 1320 are radially expanded in different directions along the radial direction; when the clamping member 1300 is in the locked state, all the clamping arms 1320 retract into the push cable 1100 and converge toward the central axis of the push cable 1100, and at least one hook 1310 is connected to or interleaved with the clamping arms 1320 to form an annular enclosure, or at least two hooks 1310 are connected to or interleaved to form an annular enclosure. Referring to fig. 10, when only one hook 1310 is provided at the distal end of one of the gripping arms 1320, the hook 1310 cooperates with the other gripping arms 1320 to form an annular closed structure. When the hook members 1310 are provided at the distal ends of the plurality of gripping arms 1320, respectively, each of the hook members 1310 may be engaged with the other gripping arms 1320 to form an annular closed structure, and each of the hook members 1310 may be engaged with the other hook members 1310 to form an annular closed structure.

In the present invention, the extension of the hook 1310 toward the central axis of the pushing wire rope 1100 means that the end of the hook 1310 faces the central axis of the pushing wire rope 1100, and the extension of the hook 1310 away from the central axis of the pushing wire rope 1100 means that the end of the hook 1310 faces away from the central axis of the pushing wire rope 1100. The hook 1310 is connected with each other, namely the end faces of the ends of at least two hook 1310 are contacted and pressed, or the end faces of the ends of the hook 1310 are contacted and pressed with the end faces of the clamping arms 1320 to form an annular closed structure; the staggering of the hook members 1310 means that the hook members 1310 cross each other at least at the ends to form a ring-shaped closed structure, or the ends of the hook members 1310 do not contact but overlap in radial projection on the same plane, or a plurality of hook members 1310 contact side by side at least at the ends to form a ring-shaped closed structure. Similarly, when one hook 1310 is provided, the end of the hook 1310 or the hook 1310 crosses over the clamp arm 1320 to form a loop-like closed structure.

Referring again to fig. 2, the push wire cable 1100 is made of a flexible and supportive material and can be of a smooth configuration, such as circular, semi-circular, etc., in cross-section, preferably circular. The flexible finger push wire cable 1100 herein can be bent or twisted to some extent, and the push wire cable 1100 is typically made of a biocompatible metallic or polymeric material. Preferred metallic materials are: 316 stainless steel, 304 stainless steel, the macromolecular material is: nylon, polyethylene, Pebax. In this embodiment, the push wire rope 1100 is a hollow tube with a smooth inner wall and is formed by twisting three strands of steel wires. To enhance the support of the push wire rope 1100, a wire (not shown) may also be wrapped around the exterior of the twisted strands. It is understood that in other embodiments, to enhance the smoothness and support of the push wire rope 1100, the push wire rope 1100 is coated with a coating or a metal reinforced tube; the covering membrane is made of a high polymer material with biocompatibility, and PTFE, e-PTFE or Pebax are preferable.

The inner core 1200 is of a length that is more flexible than the push wire cable 1100, and the inner core 1200 is typically a single metal wire (e.g., steel wire or nickel-titanium wire). The inner core 1200 is movably inserted into the push wire cable 1100, which means that the inner core 1200 and the push wire cable 1100 can move relatively in the axial direction and can rotate relatively therebetween.

As shown in fig. 3, a grip 1300 is disposed at the distal end of the inner core 1200. The holding member 1300 and the core 1200 may be integrally formed, or may be separately formed and then fixed together. In this embodiment, the proximal end of clamp 1300 is provided with clamp connection 1330 for connecting to inner core 1200. The connection mode between the clamping connection portion 1330 and the inner core 1200 may be a detachable fixed connection such as a threaded connection, a snap fit, an interference fit, or a non-detachable fixed connection such as a riveting, a welding, a hot pressing, etc. in this embodiment, the clamping member 1300 is welded at the distal end of the inner core 1200, so as to simplify the structure of the instrument and improve the connection firmness and the reliability of the instrument. Clamp connection 1330 and clamp arm 1320 may be made of the same material or may be made of different materials. Preferably, to ensure the proximal support of clamping element 1300, clamping connection 1330 is a supportive tubular or rod-like structure and is made of a somewhat rigid material, preferably 316 stainless steel, 304 stainless steel, nitinol, or cobalt-chromium alloy. In this embodiment, the clamping connection 1330 and the clamping arm 1320 are made of stainless steel and are integrally formed.

The clamping member 1300 includes two clamping arms 1320, and the distal ends of the two clamping arms 1320 are provided with hook members 1310, each hook member 1310 extends toward the central axis of the push cable 1100, and the two hook members 1310 extend in different directions, whereby the two hook members 1310 are staggered to form an annular closed structure. When the grasping arms 1320 are opened, the hook members 1310 leave a space between them for the attachment of the implant 200 to enter; when arms 1320 are closed, the ends of hooks 1310 are closed and staggered to form a closed loop, which is connected to the connecting portion of implant 200. It is understood that in other embodiments, a plurality of clamp arms 1320 may be provided to increase the stability of the ring-shaped enclosure and improve the connection force. Each gripping arm 1320 has a hook 1310 extending toward the central axis of the push cable 1100, i.e., when the gripping arms 1320 are closed, the ends of all the hook 1310 meet or cross each other at or near the central axis of the push cable 1100, together enclosing an annular enclosure.

When the clamping member 1300 is in a free state, the clamping arm 1320 is selected from at least one of a straight rod structure, a broken-line rod structure or a curved rod structure. In this embodiment, the holding arm 1320 is a straight rod structure with a hollow or solid structure.

When holder 1300 is in a free state, the distal ends of holding arms 1320 are radially spread out in different directions, i.e., the proximal ends of holding arms 1320 are concentrated and the distal ends are spread out. In the free state, the angle α between the at least one holding arm 1320 and the central axis of the push cable 1100 is preferably in the range of 90 ° to 150 ° or 200 ° to 270 °, i.e., 90 ° ≦ α ≦ 150 ° or 200 ° ≦ α ≦ 270 °, preferably 100 ° ≦ α ≦ 130 ° or 230 ° ≦ α ≦ 260 °. In order to form a ring-shaped closed structure, it is necessary to ensure that two adjacent clamping arms 1320 do not overlap, and an included angle α between the two clamping arms 1320 forming the ring-shaped closed structure and the central axis of the push cable 1100 is not equal. Preferably, the plurality of gripping arms 1320 are symmetrically distributed about the central axis of the push cable 1100. Therefore, when the holding member 1300 is in a free state, at least two holding arms 1320 have a certain opening angle all the time, and are not completely closed, which is more beneficial for the holding arms 1320 to be retracted into the push cable 1100, and reducing the contraction force. In this embodiment, the holding member 1300 comprises two holding arms 1320, and the included angles α between the two holding arms 1320 and the central axis of the push cable 1100 are 120 ° and 240 °, respectively, that is, the two holding arms 1320 are symmetrically disposed about the central axis of the push cable 1100.

The clamp arms 1320 are unfolded in a free state by a setting process. In order to ensure that the holding arms 1320 can be smoothly retracted after being pressed by the push cable 1100 and can be smoothly extended after releasing the restriction, the holding arms 1320 of the holding member 1300 should be made of an elastic material and the holding arms 1320 are opened in a free state by a shaping process. The elastic material refers to a material which can be bent or twisted and can be restored to the original shape when being subjected to an external force, and is preferably a shape memory material such as nickel-titanium alloy, stainless steel, cobalt-chromium alloy and the like.

The distal end of the clamp arm 1320 is provided with a hook 1310. As shown in fig. 4a-4d, the hook 1310 may be one or more short rods extending toward or away from the central axis, and the short rods may be in the shape of a straight rod, a broken-line rod structure formed by combining a plurality of straight rods, a straight rod structure with branches, or a curved rod structure. As shown in fig. 4a, the hook 1310 may be a straight rod. As shown in fig. 4b, the hook 1310 may be formed by a plurality of straight rods sequentially deflecting toward the central axis of the pushing wire cable 1100 to form a broken-line rod-shaped structure. As shown in fig. 4c and 4d, the hook 1310 is a straight rod, one of the holding arms 1320 extends to the left or right of the central axis of the push cable 1100, and the other holding arm 1320 extends along the central axis of the push cable 1100. The hook members 1310 may be identical or different in shape, so long as a ring-shaped closed structure is formed.

Referring to fig. 3, 5a and 5b, in the present embodiment, the planes of the ends of the two hook members 1310 do not overlap, i.e., the two hook members 1310 overlap to form a loop-shaped closed structure. This staggered annular closure structure provides a stronger interlocking force with implant 200. Moreover, when the two hooks 1310 are pressed by the pushing wire cable 1100, they can be overlapped to reduce the outer diameter of the holding member 1300, so the implant pushing device 10 of the present embodiment has better passing performance in the blood vessel and less damage to the patient.

As shown in fig. 5a, 5b and 6, in order to limit the relative rotation between the clamping member 1300 and the pushing wire cable 1100, ensure that the clamping member 1300 is always in the same position, and improve the stability of the annular closed structure, a limiting member 1110 is disposed at the distal end of the pushing wire cable 1100, and a limiting hole 1111 is disposed in the limiting member 1110 along the axial direction of the pushing wire cable 1100. When the clamping member 1300 is in a free state, the hook 1310 and the distal end of the clamping arm 1320 both extend out of the limiting hole 1111, and when the clamping member 1300 is in a locked state, the annular closed structure formed between the hook 1310 is located outside the limiting hole 1111, that is: the hook 1310 is located outside the retaining hole 1111 and the distal ends of the retaining arms 1320 connected to the proximal end of the hook 1310 are folded together in the retaining hole 1111. It is understood that in other embodiments, when the hook 1310 and the retaining arm 1320 form a loop-like closed structure, the loop-like closed structure is located outside the position-limiting hole 1111, that is, the hook 1310 is located outside the position-limiting hole 1111, the distal portion of the retaining arm 1320 connected to or interlaced with the hook 1310 to form the loop-like closed structure is also located outside the position-limiting hole 1111, and the retaining arm 1320 connected to the proximal end of the hook 1310 is received in the position-limiting hole 1111 and is folded together with the proximal portion of the other retaining arm 1320 in the position-limiting hole 1111.

The cross section of the limiting hole 1111 is rectangular, oval or oblate. In this embodiment, the two clamping arms 1320 of the clamping member 1300 both protrude from the limiting hole 1111 of the limiting member 1110. The cross section of the limiting hole 1111 is oblate, and can accommodate the two hook members 1310 and the clamping arm 1320 in a locking state. The size of the long axis of the limiting hole 1111 is larger than the size of the outermost side of each clamping arm 1320 of the clamping piece 1300 in the locking state on the plane perpendicular to the axial direction of the inner core 1200 and smaller than the size of each hook 1310 of the clamping piece 1300 in the locking state on the plane perpendicular to the axial direction of the inner core 1200, so that the clamping arms 1320 can be smoothly folded and enter the limiting hole 1111 in the locking state, and the hook 1310 abuts against the far end of the limiting piece 1110 and cannot enter the limiting hole 1111; the minor axis dimension of the limiting hole 1111 is approximately equal to the sum of the dimensions of the proximal end portions of the plurality of holding arms 1320 in the plane perpendicular to the axial direction of the core 1200, so that the proximal end portions of the holding arms 1320 can be folded together in the limiting hole 1111, and the holding arms 1320 can smoothly extend out of the limiting hole 1111. The plurality of gripping arms 1320 are closely overlapped and do not radially offset, thereby ensuring that the hook members 1310 connected with the gripping arms 1320 are closely connected or staggered to form a ring-shaped closed structure, and ensuring the connection effectiveness.

The stoppers 1110 are preferably made of a hard biocompatible material (e.g., stainless steel) to ensure that the clamping members 1300 can be overlapped and closed after being pressed by the stoppers 1110.

The connection between the implant pusher 10 and the implant 200 of this embodiment has some flexibility for the following reasons: upon connection between holder 1300 and implant 200, pusher assembly 1000 can be deflected in the axial direction of implant 200 in the plane of the connection of implant 200 by an angle C1 in the range of 0 to 180. In addition, the pushing assembly 1000 can also deflect in a plane perpendicular to the plane of the connection portion of the implant 200, and the deflection angle C2 ranges from 0 degrees to 180 degrees, so that the implant pushing device 10 of the present embodiment has stronger adaptability in a curved blood vessel.

Referring to fig. 1 and 8, a handle assembly 2000 is provided at the proximal end of the pusher 1000 for manipulating the connection or disconnection between the pusher 1000 and the implant 200. The handle assembly 2000 includes a handle 2100 and an axial drive control mechanism 2300 provided on the handle 2100.

The handle 2100 includes a first housing 2110 and a second housing disposed opposite to each other and fixedly connected together by means of snap-fit, adhesive, etc. The handle 2100 is used for an operator to hold, and the shape of the outer wall of the handle is not limited, so that the handle is convenient to hold.

The handle 2100 is fixedly connected to the proximal end of the push cable 1100, while the axial drive control mechanism is fixedly connected to the inner core 1200. The axial drive control mechanism 2300 is disposed proximally of the handle 2100 and provides limited axial movement along the handle 2100. Therefore, an operator can drive the inner core 1200 to move relative to the push steel cable 1100 by operating the axial movement of the axial driving control mechanism 2300 with one hand, so as to realize the opening and locking of the clamping piece 1300, thereby achieving the purpose of quickly releasing the implant 200.

Example two

The structure of the implant pushing device of the second embodiment is substantially the same as that of the implant pushing device of the first embodiment, except that the shape of the holder is different from that of the holder of the first embodiment.

Specifically, referring to fig. 9 to 11, the holding arm 1320 is an arc curved away from the central axis, the hook 1310 is an arc having an opening directed toward the central axis, and an angle β between a tangent of the arc middle portion of the holding arm 1320 and the central axis is in a range of 90 ° to 150 °. Such arcuate clamping arms 1320 and hooks 1310 may further facilitate reducing bending stresses on clamping member 1300 and increasing fatigue strength of clamping member 1300.

EXAMPLE III

The structure of the implant pushing device of the third embodiment is substantially the same as that of the implant pushing device of the first embodiment, except that the structure of the holder is different from that of the holder of the first embodiment.

As shown in FIG. 12, each of the retaining arms 1320 has a first segment 1320a and a second segment 1320B connected from a proximal end to a distal end, the first segment 1320a extending outwardly along the central axis at an angle A in the range of 120 DEG A to 180 DEG from the central axis, the second segment 1320B connected to the distal end of the first segment 1320a and extending inwardly along the central axis, the second segment 1320B extending inwardly from the first segment 1320a at an angle B in the range of 90 DEG B to 150 deg. Thus, when clamp 1300 of the present embodiment is in a free state, two clamp arms 1320 intersect. The distal end of the second segment 1320b of the retaining arm 1320 has a hook 1310. the hook 1310 can be one or two short, curved or a combination of short and curved bars that extend toward or away from the central axis of the push cable 1100. In this embodiment, the distal ends of the hook 1310 of the two clamping arms 1320 are opposite each other toward the central axis, and when the clamping arms 1320 are retracted proximally and the clamping member 1300 is in the locked state, the distal ends of the hook 1310 overlap to form a closed loop structure.

As shown in fig. 13, when the holding member 1300 is in the free state, the first segment 1320a of the holding arm 1320 is accommodated in the push wire rope 1100 and the stopper 1110, and the second segment 1320b of the holding arm 1320 extends from the stopper hole 1111 of the stopper 1110 and expands in the radial direction.

As shown in figure 14, when the push wire cable 1100 and the inner core 1200 move relative to each other, the second segment 1320b of the clamping arm 1320 is pressed by the limiting hole 1111 of the limiting member 1110 until the clamping arm 1320 is completely received in the limiting member 1110, and the hook member 1310 overlaps and crosses the limiting member 1110 to form a ring-shaped closed structure, locking the connection with the implant 200. During the locking connection process, the whole clamping piece 1300 is overlapped twice in a staggered way, so that the locking is firmer, and the connection failure between the implant pushing device 10 and the implant 200 can be effectively avoided.

Example four

The structure of the implant pushing device of the fourth embodiment is substantially the same as that of the implant pushing device of the first embodiment, except that the structure of the handle assembly of the fourth embodiment is different from that of the handle assembly of the first embodiment.

In particular, referring to fig. 15-17, the handle 2100 includes a first housing 2110 and a second housing 2120. The handle 2100 has a control groove 2200 formed therein in the axial direction. The length of the control slot 2200 is greater than or equal to the maximum relative movement distance between the push cable 1100 and the core 1200 to enable the transition of the clamp 1300 between the free state and the locked state. The control slot 2200 may be formed directly in the first housing 2110 or the second housing 2120, or may be formed by forming a slot in each of the first housing 2110 and the second housing 2120 and then fastening them together to form the control slot 2200.

The axial driving control mechanism 2300 includes a sliding member 2330 connected to the push cable 1100 or the core 1200, and a connecting member 2320 connected to the sliding member 2330, wherein the connecting member 2320 penetrates from the control slot 2200 to the outside of the handle 2100, and the connecting member 2320 slides in the axial direction and drives the sliding member 2330 to move, so as to drive the axial relative movement between the push cable 1100 and the core 1200.

In this embodiment, the slider 2330 is coupled to the proximal end of the push cable 1100 by a screw, snap, interference fit, pin, weld, rivet, etc. as is common in the art, and the proximal end of the core 1200 is secured to the handle 2100 by a core retainer after extending from the proximal end of the push cable 1100. The inner core fixing piece comprises a stroke portion 1230 fixedly connected with the inner core 1200 and an adjusting portion 2130 fixedly connected with the handle 2100, and the adjusting portion 2130 is movably connected with the stroke portion 1230. In this embodiment, the proximal end of the inner core 1200 is connected to a threaded rod as the stroke portion 1230, and a nut as the adjustment portion 2130 is disposed in the handle 2100, the threaded rod being adapted to the nut. Thus, when assembling the plunger 1200 in the handle 2100, the operator can adjust the relative positions of the plunger 1200, the handle 2100 and the push cable 1100 by adjusting the position of the nut on the screw, thereby preventing the plunger 1200 from being pulled excessively or the plunger 1200 from being too loose, which affects the locking effect of the clamp 1300.

A guide is provided in the handle 2100 to limit the slider 2330 to move axially along the guide, ensuring smooth sliding of the slider 2330. The guide may be in the form of a groove in which the slider 2330 is a sliding fit; the guide member may be in the form of a rod-shaped body, and the slider 2330 is inserted into the rod-shaped body to move axially along the rod-shaped body.

The connecting member 2320 is inserted into the control slot 2200 and penetrates out of the handle 2100 from the control slot 2200, so as to facilitate the operation of the operator.

The slider 2330 has a resilient member 2500 attached to its proximal or distal end, which upon compression or repositioning of the resilient member 2500 causes axial movement of the axial drive control mechanism 2300 to drive axial relative movement between the push cable 1100 and the core 1200. Specifically, when the slider 2330 is coupled to the core 1200, the elastic member 2500 is coupled to the distal end of the slider 2330; when the slider 2330 is attached to the push cable 1100, the resilient member 2500 is attached to the proximal end of the slider 2330. Thus, when the spring 2500 is compressed, the push wire cable 1100 moves proximally, and the holder 1300 extends from the push wire cable 1100, in a free state, to which the implant 200 can be attached; when the elastic member 2500 is restored by its own elasticity, the push wire 1100 is moved distally, the holding member 1300 is retracted into the push wire 1100, and the hooks 1310 are overlapped to form a ring-shaped closed structure, locking the connection with the implant 200.

In this embodiment, the elastic member 2500 is in the form of a spring, and it is understood that in other embodiments, the elastic member 2500 may also be in the form of an elastic rod.

A drive stop is also provided axially within the handle 2100 for limiting radial movement of the resilient member 2500, which may be disposed on either the proximal or distal side of the guide 2180. Specifically, in the present embodiment, a strip-shaped groove is provided in the handle 2100 as a driving stopper, and the elastic member 2500 is accommodated in the strip-shaped groove. It will be appreciated that in other embodiments, the resilient member 2500 may be fitted over a rod-shaped body that acts as a drive stop.

In this embodiment, since the elastic member 2500 has elasticity, the axial driving control mechanism 2300 is pressed by the elastic member 2500, and the clamping member 1300 is always kept in a locked state, thereby preventing the pushing assembly 1000 from being accidentally disconnected from the implant 200. Only when the operator operates the axial driving control mechanism 2300, the elastic member 2500 is compressed against the elastic force of the elastic member 2500, the push wire cable 1100 is retracted, and the holding member 1300 is extended from the push wire cable 1100, thereby releasing the connection with the implant 200, and the operation is simple.

EXAMPLE five

The structure of the implant pushing device of the fifth embodiment is substantially the same as that of the implant pushing device of the fourth embodiment, except that the structure of the handle assembly of the fifth embodiment is different from that of the handle assembly of the fourth embodiment.

Referring to fig. 18 and 19, the handle 2100 is provided with a control slot 2200, a first detent 2210 at a distal end, and a second detent 2220 at a proximal end in an axial direction. The first detent 2210 and the second detent 2220 are radially offset with respect to the control slot 2200, and they may be radially offset on the same side of the control slot 2200, or radially offset on both sides of the control slot 2200. The first detent 2210 and the second detent 2220 are both in communication with the control slot 2200, whereby the axial drive control mechanism 2300 is movable within the control slot 2200 and the first detent 2210 and the second detent 2220. When the axial drive control mechanism 2300 is shifted in the first detent 2210 and the second detent 2220, the clamping member 1300 is shifted between the locked state and the free state. Specifically, when the slider 2330 of the axial drive control mechanism 2300 is connected to the push wire cable 1100 and the connecting member 2320 of the axial drive control mechanism 2300 is switched to the second detent 2220 at the proximal end, the push wire cable 1100 moves proximally, and the holder 1300 protrudes from the push wire cable 1100 and is in a free state, and the implant 200 can be connected; when the connection member 2320 is shifted into the first detent 2210 at the distal end, the push wire cable 1100 is moved distally, the holding member 1300 is retracted into the push wire cable 1100, the hooks 1310 are overlapped and staggered to form a ring-shaped closed structure, and the holding member 1300 is transformed into a locking state to lock the connection with the implant 200. It will be appreciated that in other embodiments, the slider 2330 may also be coupled to the core 1200 such that the clamp 1300 is free when the axial drive control mechanism 2300 is in the first detent 2210; when the axial drive control mechanism 2300 is in the second detent 2220, the clamp 1300 is in a locked state.

In this embodiment, when the position of the axial driving control mechanism 2300 is switched, the connecting member 2320 axially slides along the control slot 2200 until reaching the first detent 2210 or the second detent 2220, and then shifts toward the first detent 2210 or the second detent 2220, so that the axial driving control mechanism 2300 can be locked into the first detent 2210 or the second detent 2220 to complete the switching of the clamping member 1300, thereby locking or releasing the connection with the implant 200, which is simple and convenient to operate and can rapidly release the implant 200.

EXAMPLE six

Referring to fig. 20, the implant delivery system 100 provided in the sixth embodiment comprises an implant pushing device 10, an expanding device 20, a loading device 30, a hemostatic device 40 and an outer sheath 50. The structure of the implant pushing device 10 is substantially the same as that of the implant pushing device 10, and the description thereof is omitted.

Referring to fig. 21, the distal end of the expansion device 20 passes out of the distal end of the outer sheath 50 to form an expansion assembly. The distal end of the stent assembly follows a track established by a guidewire (not shown) to the intended treatment site within the patient's body, and the stent 20 is then withdrawn, leaving the outer sheath 50 in place, thus establishing an extracorporeal passageway to the body. Referring to fig. 22, after the passage from the outside of the body to the inside of the body is established, the proximal end of the loading device 30 is connected to the distal end of the hemostatic device 40, the distal end of the implant pushing device 10 is sequentially passed out of the hemostatic device 40 and the loading device 30, and is detachably connected to the proximal end of the implant 200, and then the pushing device 10 is withdrawn proximally to retract the implant 200 into the loading device 30. Referring to FIG. 23, the distal end of the loading device 30 is connected to the proximal end of the outer sheath 50, and the pushing device 10 is operated to push the implant 200 distally until the implant 200 is pushed out of the distal end of the outer sheath 50, the implant 200 is disconnected from the implant pushing device 10 and returns to the expanded state, and the release and implantation of the implant 200 are completed.

Referring to FIG. 24, the outer sheath 50 is hollow inside for passage of the expansion device 20 or for pushing a cable 1100. The tube wall of the outer sheath tube 50 is a multi-layer structure, and sequentially comprises a polytetrafluoroethylene material layer, a stainless steel woven layer and a polyether block amide layer from inside to outside. The polytetrafluoroethylene material layer is located at the innermost layer, and because the friction coefficient of the material is extremely low, the resistance of the pushing steel cable 1100 and the implant 200 in the outer sheath 50 is small; the polytetrafluoroethylene material layer can resist acid and alkali, and blood, developing liquid and the like can not damage the polytetrafluoroethylene material layer; the stainless steel braid layer has high strength so that the outer sheath tube 50 is not easily damaged. The polyether block amide layer is located on the outermost layer, and the polyether block amide layer has good mechanical elasticity, chemical stability and thermal stability, so that the outer sheath tube 50 has good bending performance and is not easy to damage. Sheath 50 also includes at least one side branch for connection to an external device (not shown) for delivering fluids such as drugs or contrast agents, and also for preventing the entry of air into the vessel during surgery. The outer sheath 50 is provided with a sheath holder 52 at its proximal end for connection to the stent 20 or loading device 30. Sheath base 52 is T-shaped or Y-shaped, here T-shaped.

Referring to fig. 25, an elastic sealing member 521 is provided in the sheath tube seat 52. The elastic seal 521 is made of an elastic material, and the elastic seal 521 is provided with at least one aperture along the axial direction of the pushing device 10 for the passage of the pushing wire cable 1100.

Referring to fig. 26, 27a and 27b, the elastic sealing member 521 is a cylinder, a proximal end of the elastic sealing member 521 forms an elongated first slit 5211, a distal end of the elastic sealing member 521 forms an elongated second slit 5212, and the sum of the thicknesses of the first slit 5211 and the second slit 5212 is equal to the thickness of the elastic sealing member 521, wherein the thickness refers to the axial length of the sheath seat 52. In the present embodiment, the thickness of the first slit 5211 is the same as the thickness of the second slit 5212, and is equal to half the thickness of the elastic seal 521, i.e., the first slit 5211 is located at the proximal half of the elastic seal 521, the second slit 5212 is located at the distal half of the elastic seal 521, and the first slit 5211 and the second slit 5212 do not overlap in the thickness direction. The first slit 5211 and the second slit 5212 are oriented differently, where the direction of extension of the first slit 5211 is transverse and the direction of extension of the second slit 5212 is longitudinal. The first slit 5211 and the second slit 5212 intersect in a projection of the distal surface of the elastic seal 521, which in this embodiment is the center of the surface of the distal end of the elastic seal 521. Preferably, the projections of the first and

second slits

5211 and 5212 on the distal surface of the resilient seal 521 are perpendicular to each other, i.e., form a cross. Since the two slits of the proximal and distal surfaces of the resilient sealing member 521 form an intersection, the intersection is relatively weak and easily penetrated, and the intersection becomes the only passage for the insertion tube such as the push cable 1100 or the expansion device 20 to pass through the resilient sealing member 521. Since the elastic sealing member 521 is made of an elastic material, when the interventional tube is withdrawn, the penetrated elastic sealing member 521 tends to close again, and there is substantially no hole or gap after closing, so that the elastic sealing member 521 of the present embodiment can achieve an automatic sealing effect. After the elastic sealing element 521 of the present embodiment is installed in the sheath tube seat 52 and the push steel cable 1100 is continuously passed through and pulled out of the elastic sealing element 521 three times, the sealing performance of the sheath tube seat 52 can still reach 1.5ATM (standard atmospheric pressure), which can effectively prevent blood leakage and ensure air tightness.

Referring to fig. 28, the stent 20 comprises a stent 21 and a stent holder 22, the proximal end of the stent 21 is connected to the distal end of the stent holder 22, the stent 21 is made of polyethylene, and the outer diameter of the stent 21 is slightly smaller than the inner diameter of the outer sheath 50. The dilation tube 21 further comprises a tip head 23 at the distal end, the tip head 23 being tapered with an outer diameter that increases from the distal end to the proximal end. Thus, when the stent assembly comprising the stent 20 and the sheath 50 is advanced over the guidewire and passed through a stenotic vessel, the tip 23 can dilate the vessel and facilitate the smooth passage of the stent assembly.

Referring to fig. 29, after establishing an extracorporeal passage to the body, the distal end of the loading unit 30 is connected to the proximal end of the sheath tube 50 by screwing or the like, and the hollow loading unit 30 is used to receive and pass the compressed implant 200.

Referring to fig. 30, the hemostatic device 40 is attached to the proximal end of the loading device 30, the hemostatic device 40 is hollow and in communication with the loading device 30, and a push wire cable 1100 is threaded through the proximal end of the hemostatic device 40, out the distal end of the hemostatic device 40 and attached to the implant 200. The hemostatic device 40 is provided with an elastic sealing member 41, and the structure of the elastic sealing member 41 may be a common seal ring or a seal gasket, or may be the same as the structure of the elastic sealing member 521 in the sheath tube seat 52. It is understood that in other embodiments, an elastomeric seal may be provided in the loading device 30, in which case the implant delivery system 100 may not require a hemostatic device 40. The elastic sealing member in the loading device 30 may be a gasket or a gasket, and may have the same structure as the elastic sealing member 521 in the sheath tube seat 52.

It is understood that in other embodiments, the implant delivery system 100 may not include the loading device 30, with the proximal end of the sheath 50 being directly connected to the distal end of the hemostatic device 40.

It should be noted that, in the present specification, the embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments may be referred to each other.

The above disclosure is only for the purpose of illustrating the preferred embodiments of the present invention, and it is therefore to be understood that the invention is not limited by the scope of the appended claims.

Claims

1. A lockable implant pushing device comprises a pushing assembly and a handle assembly connected with the near end of the pushing assembly, and is characterized in that the pushing assembly comprises a hollow pushing steel cable, an inner core movably arranged in the pushing steel cable in a penetrating way, and a clamping piece arranged at the far end of the inner core and detachably connected with an implant; the holder includes two at least centre gripping arms, at least one the centre gripping arm distal end is equipped with the hook, the hook orientation the axis direction of propelling movement steel cable extends or deviates from the axis direction of propelling movement steel cable extends, and is a plurality of the extending direction of hook is different.

2. The implant pushing device according to claim 1, wherein the planes of the distal ends of at least two of the hooks do not overlap.

3. The implant pusher of claim 2, wherein the holder has a free state and a locked state, and when the holder is in the free state, the distal ends of the holding arms extend beyond the distal end of the pusher cable, and all the distal ends of the holding arms are radially expanded in different directions, respectively; when the clamping pieces are in a locking state, all the clamping arms retract towards the pushing steel cable and are folded towards the central axis of the pushing steel cable, and at least one of the hook pieces is connected with the clamping arms or staggered with the clamping arms to form an annular closed structure, or at least two of the hook pieces are connected with each other or staggered with the clamping arms to form an annular closed structure.

4. The implant pushing device according to claim 3, wherein in the free state, an included angle between at least one of the clamping arms and the central axis of the pushing wire cable ranges from 90 ° to 150 ° or from 200 ° to 270 °, and included angles between two of the clamping arms forming the annular closed structure and the central axis of the pushing wire cable are not equal.

5. The implant pushing device according to claim 3, wherein the distal end of the pushing wire cable is provided with a limiting member, the limiting member is provided with a limiting hole along the axial direction of the pushing wire cable, the hook member and the distal end of the clamping arm both extend out of the limiting hole when the clamping member is in a free state, the hook member is located outside the limiting hole when the clamping member is in a locked state, and the distal end of the clamping arm connected to the proximal end of the hook member is folded together in the limiting hole.

6. The implant pushing device according to claim 5, wherein the long axis dimension of the limiting hole is larger than the outermost dimension of each clamping arm of the clamping piece in the locking state on a plane perpendicular to the axial direction of the inner core and smaller than the dimension of each hook of the clamping piece in the locking state on the plane perpendicular to the axial direction of the inner core; the minor axis of the limiting hole is approximately equal to the sum of the sizes of the proximal end parts of the clamping arms on a plane perpendicular to the axial direction of the inner core.

7. The implant pusher device of claim 1, wherein the handle assembly includes a handle and an axial drive control mechanism disposed on the handle that moves axially relative to the handle to drive axial relative movement between the push cable and the inner core.

8. The implant pusher of claim 7, wherein the handle has a control slot disposed therein in an axial direction, the axial drive control mechanism moving axially in the control slot.

9. The implant pusher device of claim 8, wherein the handle assembly further comprises a resilient member disposed at a proximal end or a distal end of the axial drive control mechanism, wherein compression or repositioning of the resilient member causes axial movement of the axial drive control mechanism to drive axial relative movement between the push cable and the inner core.

10. The implant pusher device of claim 9, wherein the distal end of the axial drive control mechanism is connected to the pusher cable and the proximal end of the axial drive control mechanism is connected to the resilient member.

11. The implant pusher of claim 8, wherein the handle further comprises at least two detents radially offset from and in communication with the control slot, the axial drive control mechanism moving in the control slot and the detents.

12. The implant pusher device of claim 11, wherein the detents comprise a first detent at a distal end and a second detent at a proximal end, the grip transitioning between a locked state and a free state when the axial drive control mechanism switches between the first detent and the second detent.

13. The implant pusher device of claim 12, wherein the axial drive control mechanism is coupled to the pusher cable, the holder being locked when the axial drive control mechanism is in the first detent position; when the axial drive control mechanism is positioned in the second clamping position, the clamping piece is in a free state.

14. An implant delivery system comprising the implant pusher of any one of claims 1-13, and further comprising an outer sheath having an axial length, the implant pusher being movably disposed through the outer sheath and removably coupled to the proximal end of the outer sheath.

15. The implant delivery system of claim 14, further comprising an expansion device movably mounted through the sheath, wherein a proximal end of the expansion device is removably coupled to a proximal end of the sheath.

16. The implant delivery system of claim 15, further comprising a loading device removably connected between the outer sheath proximal end and the pusher distal end.

17. The implant delivery system of claim 16, further comprising a hemostatic device removably coupled between the loading device and the pusher device distal end.

18. The implant delivery system of claim 17, wherein at least one of the sheath, the loading device, and the hemostatic device has a resilient seal disposed therein, the resilient seal having at least one aperture disposed axially of the pusher device.

19. The implant delivery system of claim 18, wherein a proximal end of the resilient seal member defines a first slit and a distal end of the resilient seal member defines a second slit, a sum of thicknesses of the first and second slits being equal to a thickness of the resilient seal member, the first and second slits being oriented in different directions, a projection of the first slit onto a distal surface of the resilient seal member intersecting a projection of the second slit onto the distal surface of the resilient seal member.

20. The implant delivery system of claim 19, wherein a projection of the first slit on the resilient seal distal surface is perpendicular to a projection of the second slit on the resilient seal distal surface.