CN214104771U

CN214104771U - Operating handle for delivering interventional device to human body

Info

Publication number: CN214104771U
Application number: CN202021304323.7U
Authority: CN
Inventors: 吴世广; 王翔; 高彬; 张维
Original assignee: Hangzhou Qiming Medical Devices Co ltd
Current assignee: Hangzhou Qiming Medical Devices Co ltd; Venus Medtech Hangzhou Inc
Priority date: 2020-07-06
Filing date: 2020-07-06
Publication date: 2021-09-03
Anticipated expiration: 2030-07-06

Abstract

The application discloses an operating handle for carrying intervention apparatus to human body for connect the near-end of three nested pipe fittings in proper order inside and outside, and the near-end relative motion each other of three pipe fittings of drive, three pipe fittings are by interior and outer core pipe, transfer return bend and sheath pipe respectively, operating handle includes control assembly, transfers curved subassembly and front end handle. This application is through operating handle's setting, realizes that fine and smooth stable regulation is felt to can guarantee each pipe fitting relative position relation in accommodation process, thereby realize conveying system's stable accent is bent, makes things convenient for operating personnel such as clinicians to develop the treatment process, has higher spreading value.

Description

Operating handle for delivering interventional device to human body

Technical Field

The utility model belongs to the technical field of medical instrument, especially, relate to an operating handle for carrying intervention apparatus to human body.

Background

The interventional device conveying system generally comprises a sheath core assembly and a sheath tube which is sleeved outside the sheath core assembly in a sliding mode, the sheath tube and the sheath tube form a sheath tube assembly, the far end of the sheath tube assembly can enter a human body vascular system, the near end of the sheath tube assembly is connected with an operating handle, and the direction of the far end needs to be adjusted and controlled to enable the sheath tube assembly to move to a target position based on the tortuous characteristic of the human body vascular system and the consideration of remote operation. Therefore, the driving requirement is provided for the operating handle, and the technical requirements of convenience in holding, convenience in adjustment and accuracy in positioning can be met when operating personnel such as clinicians use the operating handle.

SUMMERY OF THE UTILITY MODEL

In order to solve the technical problem, the application provides an operating handle for conveying an interventional instrument to a human body, which is used for connecting the near ends of three pipe fittings which are nested inside and outside in sequence and driving the near ends of the three pipe fittings to move relative to each other, wherein the three pipe fittings respectively comprise a core pipe, a bending adjusting pipe and a sheath pipe from inside to outside, and the operating handle comprises a control assembly, a bending adjusting assembly and a front-end handle;

the control assembly includes:

a first support fixed to the front end handle;

the first connecting piece is slidably mounted on the first support body, and the proximal end of the sheath tube is fixed to the first connecting piece;

the first driving piece is movably arranged on the first supporting body and drives the first connecting piece to slide;

the bend adjustment assembly comprises:

a second support fixed opposite to the first support;

the second connecting piece is slidably arranged on the second support body, and the near end of the bend adjusting pipe penetrates through the sheath pipe and then is fixed on the second connecting piece;

the second driving piece is movably arranged on the second supporting body and drives the second connecting piece to slide;

and the pipe joint is fixedly arranged at the near end of the second support body, and the near end of the core pipe penetrates out of the bend adjusting pipe and then is fixed on the pipe joint.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the first driving part is rotatably sleeved on the periphery of the first supporting body, and a limiting mechanism for limiting the rotation angle of the first driving part is arranged between the front-end handle and the first driving part.

Optionally, the limiting mechanism includes:

a slide key mounted to one of the front end handle and the first driver;

the lockhole is formed in the other one of the front end handle and the first driving piece.

Optionally, a sliding groove is formed in the outer wall of the front-end handle, the sliding key is installed in the sliding groove, and the locking hole is formed in the axial end face of the first driving piece.

Optionally, the limiting mechanism includes a locking pin which is installed on the first driving member in a threaded manner and abuts against the first supporting body.

Optionally, the first supporting body is a cylindrical shape, a guide strip hole extending along the axial direction is formed in the side wall of the first supporting body, the first connecting piece is slidably mounted inside the first supporting body, a guide key extending out of the guide strip hole along the radial direction is arranged on the first connecting piece, and a threaded structure matched with the guide key is arranged on the inner wall of the first driving piece.

Optionally, the second support body is cylindrical and is arranged coaxially with the first support body, and the second support body and the first support body are fixed by adopting an integral structure or a split structure.

Optionally, the second driving element is rotatably mounted with respect to the second supporting body, the second supporting body is provided with an operation opening, a part of the second driving element is disposed inside the second supporting body, and at least a part of the second driving element is exposed to the operation opening as a force application portion, and the second connecting element is located inside the second supporting body and is linked with the second driving element.

Optionally, the second driving member has an internal thread, at least a portion of the second connecting member has an external thread and extends into the second driving member, and the second driving member drives the second connecting member to slide in a threaded manner.

Optionally, the inner wall of the second supporting body is provided with a guide bar extending along the axial direction, at least one part of the second connecting piece is located in the second supporting body, and the outer wall of the part is provided with a guide groove matched with the guide bar.

This application is through operating handle's setting, realizes that fine and smooth stable regulation is felt to can guarantee each pipe fitting relative position relation in accommodation process, thereby realize conveying system's stable accent is bent, makes things convenient for operating personnel such as clinicians to develop the treatment process, has higher spreading value.

Drawings

FIG. 1 is a schematic diagram of the construction of a conveyor system according to the present application;

FIG. 2 is an exploded view of the delivery system of FIG. 1;

FIG. 3a is an internal structural schematic of the operating handle of FIG. 1;

FIG. 3b is an internal structural schematic view of the operating handle of FIG. 1 from another perspective;

FIG. 3c is an enlarged partial schematic view of FIG. 3 b;

FIG. 4 is an exploded view of the operating handle of FIG. 1;

FIG. 5a is a schematic view of a core tube assembly according to an embodiment of the present invention in which the locking element is in a line-by-wire configuration;

FIG. 5b is a schematic illustration of the locking element of FIG. 5a engaged with the access device;

FIG. 5c is a schematic view of a core tube assembly according to an embodiment of the present invention;

FIG. 6 is a schematic structural diagram of an elbow adjustment pipe according to an embodiment of the present application;

FIG. 7 is a schematic view of the core tube (compliant section) according to an embodiment of the present invention;

FIG. 8 is a schematic view of the core tube (compliant section) of FIG. 7 at another angle;

FIG. 9 is a schematic structural diagram of an elbow adjustment pipe according to an embodiment of the present application;

FIG. 10 is a schematic view of the bend adjusting pipe of FIG. 9 at another angle;

FIG. 11 is an expanded view of the elbow of FIG. 9;

FIG. 12 is a schematic structural view of a sheath according to an embodiment of the present application;

FIG. 13 is an assembled structural schematic view of the components of FIGS. 5c, 6 and 12;

FIG. 14 is a cross-sectional view of a sheath assembly according to an embodiment of the present application;

figure 15a is a schematic view of the interventional instrument of figure 14 after loading thereof;

FIG. 15b is a schematic view of the interventional instrument of FIG. 15a in a semi-released configuration;

FIG. 15c is a schematic illustration of the interventional instrument of FIG. 15a after complete release;

FIG. 15d is a schematic view of the axial segment-to-segment relationship of the pipe elements in one embodiment of the present application;

FIG. 16 is a cross-sectional view of a sheath and core assembly according to an embodiment of the present application;

fig. 17a is a schematic view of the interventional instrument of fig. 16 after loading;

FIG. 17b is a schematic view of the interventional instrument of FIG. 17a in a semi-released configuration;

FIG. 17c is a schematic illustration of the interventional instrument of FIG. 17a after complete release;

FIG. 17d is a schematic view of the axial segment-to-segment relationship of the pipes according to an embodiment of the present invention.

The reference numerals in the figures are illustrated as follows:

100. an operating handle;

110. a bending adjusting component; 111. a second support; 112. a second driving member; 113. a second connecting member; 114. a guide strip; 115. A guide groove; 116. an operation port; 117. a force application part; 118. a luer fitting;

120. a control component; 121. a first support; 122. a first driving member; 123. a first connecting member; 124. a guide key; 125. A guide bar hole; 126. a lock hole;

130. a front end handle; 131. a sliding key; 132. a chute;

200. a conduit;

300. a sheath tube; 310. a loading section; 320. a bending section; 330. a first extension section;

340. a head end tube; 343. a first connector; 344. an expansion sheet; 346. a body section;

350. a main body tube; 351. a second connector;

370. an inner sheath tube; 375. a liner tube;

380. wrapping a film;

400. a sheath-core assembly;

410. adjusting a bent pipe; 411. a first pulling section; 4111. a reinforcing rib (second reinforcing rib); 412. a second pulling section; 4121. a reinforcing rib (third reinforcing rib); 4122. a reinforcing rib (third reinforcing rib); 413. a second extension section; 414. a transition section;

420. a core tube assembly; 421. a guide head; 422. a lock; 4221. a lock hole; 4222. a distributing board; 4223. a pull wire; 4224. A lock lever; 4225. threading a sleeve; 423. layering; 424. an inner core; 425. a core tube; 4251. a compliant section; 4252. a third extension section; 4253. a rib (first rib);

500. an interventional instrument; 501. and (5) connecting lugs.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, 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 belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1-4, in one embodiment of the present application, a delivery system is provided having opposite distal and proximal ends, the delivery system including a proximal operating handle 100 and a sheath 300 and sheath core assembly 400 connected to the operating handle 100 and extending distally, the sheath 300 being a sliding fit to the outer circumference of the sheath core assembly 400.

Wherein sheath core subassembly includes the core pipe, is fixed in the core pipe distal end and is used for connecting the latch fitting of intervention apparatus, and the latch fitting can have the structure of multiple different forms, for example, adopts the engaging lug on recess form and the support to be connected, or adopts radial outside convex plush copper form, or adopts the drive-by-wire mode, adopts long line or wire loop and support connection, no matter what kind of form of adoption, its purpose all is in order to realize being connected with the support engaging lug.

In some embodiments, the sheath core assembly further comprises an adjusting pipe sleeved on the periphery of the core pipe, the distal ends of the adjusting pipe and the core pipe are fixedly connected with each other, and the proximal ends of the adjusting pipe and the core pipe are both extended and connected to the operating handle and can slide relatively.

In some embodiments, the sheath core assembly further comprises an adjustable bending tube inside the core tube, wherein the adjustable bending tube and the core tube are fixedly connected with each other at the distal ends and can slide relative to each other at the proximal ends.

The relative movement between the core tube and the bend-adjusting tube at the proximal end is required no matter how the inside-outside relationship is, generally, during bend adjustment, the proximal end of the core tube is kept unchanged, or the proximal end of the bend-adjusting tube is pulled by taking the proximal end of the core tube as a reference, and the difference of the inside-outside relationship between the core tube and the bend-adjusting tube can cause the difference of the contact position between the core tube and the bend-adjusting tube at the turning position. The following embodiments and the accompanying drawings mainly take the outside of the bend-adjusting pipe as an example. The structure of the operating handle can be correspondingly adjusted according to the internal and external relations of the core tube and the bending adjusting tube, so that the proximal ends of the core tube and the bending adjusting tube can move relatively.

In other embodiments, the delivery system may further comprise a catheter 200 fixed relative to the operating handle 100, the catheter 200 being used to establish a channel to prevent injury to body tissue as the sheath 300 reciprocates. The interventional device is loaded into the sheath core assembly 400 and is carried along with the catheter 200 into the body under the sheath 300. the sheath 300 is then axially movable relative to the other two to effect release and, if necessary, retrieval of the interventional device.

The bending is mainly achieved by operating the handle 100. Referring to fig. 3a and 4, in one embodiment, the operating handle 100 is used for connecting the proximal ends of three tubes nested inside and outside in sequence, and driving the proximal ends of the three tubes to move relative to each other, the three tubes are a core tube, a bend-adjusting tube and a sheath tube from inside to outside, and the operating handle 100 comprises a control assembly 120, a bend-adjusting assembly 110 and a front-end handle 130;

the control assembly 120 includes:

a first support 121 fixed to the front end handle 130;

a first connector 123 slidably mounted on the first support 121, wherein the proximal end of the sheath is fixed to the first connector 123;

a first driving member 122 movably mounted on the first supporting body 121 and driving the first connecting member 123 to slide;

the bend adjustment assembly 110 includes:

a second support 111 fixed to the first support 121;

the second connecting piece 113 is slidably mounted on the second support 111, and the proximal end of the bend-adjusting pipe penetrates through the sheath pipe and then is fixed on the second connecting piece 113;

a second driving member 112 movably mounted on the second supporting body 111 and driving the second connecting member 113 to slide;

and the pipe joint is fixedly arranged at the near end of the second support body 111, and the near end of the core pipe penetrates through the bend adjusting pipe and then is fixed on the pipe joint.

Specifically, the control assembly 120 includes a first supporting body 121, the first driving member 122 is rotatably sleeved on the periphery of the first supporting body 121, a guide bar hole 125 extending along the axial direction is formed in the side wall of the first supporting body 121, a first connecting member 123 is slidably mounted inside the first supporting body 121, a guide key 124 extending from the guide bar hole 125 is arranged on the first connecting member 123, and a threaded structure matched with the guide key 124 is arranged on the inner wall of the first driving member 122.

In the configuration of the first supporting body 121, referring to an embodiment, the first supporting body 121 is cylindrical, a hole of the guide bar 114 extending along the axial direction is formed in a side wall of the first supporting body 121, the first connecting member 123 is slidably installed inside the first supporting body 121, a guide key 124 extending out of the hole of the guide bar 114 along the radial direction is arranged on the first connecting member 123, and a threaded structure matching with the guide key 124 is arranged on an inner wall of the first driving member 122.

Specifically, the first supporting body 121 is substantially cylindrical, and may adopt an integral or radial snap-fit split structure (as shown in fig. 4), when the first driving member 122 rotates, the guide key 124 drives the first connecting member 123 to slide in the first supporting body 121, and due to the limitation of the guide bar hole 125, the first connecting member 123 does not rotate, i.e., only moves axially.

The front handle 130 is fixedly connected to the first support 121, the proximal end of the catheter 200 is fixedly inserted into the front handle 130, the proximal end of the sheath 300 is fixedly mounted to the first connector 123, and the sheath 300 extends distally through the catheter 200.

In the matching relationship between the first supporting body 121 and the second supporting body 111, referring to an embodiment, the second supporting body 111 is cylindrical and is coaxially arranged with the first supporting body 121, and the second supporting body 111 and the first supporting body 121 are fixed together by an integral structure or a separate structure.

In the matching relationship between the second driving element 112 and the second supporting body 111, referring to an embodiment, the second driving element 112 is rotatably mounted with respect to the second supporting body 111, the second supporting body 111 is provided with an operation opening 116, a portion of the second driving element 112 is disposed inside the second supporting body 111, and at least a portion of the second driving element is exposed to the operation opening 116 as a force application portion 117, and the second connecting element 113 is disposed inside the second supporting body 111 and is linked with the second driving element 112.

Specifically, the bending adjustment assembly 110 includes a second supporting body 111, the second supporting body 111 is also substantially cylindrical and is fixed relative to the first supporting body 121, the second supporting body 111 itself may adopt a split structure (as shown in fig. 4) that is integrally or radially fastened, and the second supporting body 111 and the first supporting body 121 are coaxially arranged and adopt a split fixed butt joint manner.

Correspondingly, the bend adjustment assembly 110 further includes a second driving member 112, and in the specific configuration of the second driving member 112, referring to an embodiment, the second driving member 112 is provided with an internal thread, at least a portion of the second connecting member 113 is provided with an external thread and extends into the second driving member 112, and the second driving member 112 drives the second connecting member 113 to slide in a threaded manner.

Specifically, the second driving member 112 is rotatably mounted relative to the second supporting body 111, an operation opening 116 is partially formed in the second supporting body 111, a part of the second driving member 112 is disposed inside the second supporting body 111, and at least a part of the second driving member is exposed to the operation opening 116 as a force application portion 117, the second driving member 112 is integrally cylindrical and has an internal thread, and the second connecting member 113 is slidably mounted inside the second driving member 112.

In order to limit the movement of the second connecting member 113, referring to an embodiment, the inner wall of the second supporting body 111 is provided with a guide bar 114 extending along the axial direction, at least a portion of the second connecting member 113 is located in the second supporting body 111 and the outer wall of the portion is provided with a guide groove 115 cooperating with the guide bar 114. In this embodiment, the cooperation of the guide groove 115 and the guide bar 114 enables the second connector 113 to slide only in the axial direction with respect to the second support body 111.

As can be readily understood from the above description, the bending adjustment function of the operating handle 100 is mainly realized by the rotation of the components, and a corresponding limiting mechanism can be provided to prevent the unstable bending adjustment state caused by the mutual movement of the components in the operating process. In an embodiment, the first driving member 122 is rotatably sleeved on the outer periphery of the first supporting body 121, and a limiting mechanism for limiting a rotation angle of the first driving member 122 is disposed between the front handle 130 and the first driving member 122.

Accordingly, the present embodiment exemplarily provides an arrangement manner of the limiting mechanism. In reference to an embodiment, the limiting mechanism includes:

a slide key 131 mounted to one of the front end handle 130 and the first driving member 122;

a lock hole 126 opened in the other of the front handle 130 and the first driving member 122.

When the sliding key 131 is engaged with the lock hole 126, the position of the front end knob 130 and the first driving member 122 in the circumferential direction is determined, and therefore the axial position of the first connecting member 123 with respect to the front end knob 130 is determined, and the function of the operating handle 100 for bending is limited, ensuring stability during use. In practical products, as for a specific arrangement, in an embodiment, the outer wall of the front end handle 130 is provided with a sliding slot 132, the sliding key 131 is installed in the sliding slot 132, and the locking hole 126 is provided on an axial end surface of the first driving member 122.

The locking holes 126 can achieve locking of the first driving member 122 in multiple positions by increasing the number of the locking holes. Referring to fig. 3c, the locking holes are provided in plurality on an axial end surface of the first driver 122, and are sequentially arranged along a circumferential surface of the first driver 122. The increase in the number of the locking holes 126 may increase the locking positions of the first driving member 122, but correspondingly, the increase in the number of the locking holes 126 may increase the manufacturing difficulty of the first driving member 122 and may decrease the gap between adjacent locking holes 126, thereby decreasing the strength of a single locking hole 126, and thus the specific number may be adjusted according to design requirements, practical conditions, and practical product sizes.

In the embodiment shown in fig. 3b and 3c, since the first driving member 122 is a split structure that is fastened up and down, the locking hole 126 near the separation point has two arrangements, one is an arrangement that is open toward the separation point, and the other is an arrangement that is closed to avoid the separation point. In a particular product, only one of the two arrangements may be present.

Accordingly, a limiting mechanism may be disposed between the first driving member 122 and the first supporting member 121 to achieve the above-mentioned functions. In one embodiment, the limiting mechanism includes a locking pin (not shown) threadedly mounted on the first driving member 122 and abutting against the first supporting body 121. The bolt joint of the locking pin and the first driving member 122 can realize the relative position of the locking pin and the first driving member 122, thereby realizing the positioning of the first supporting body 121. When the relative position between the first driving member 122 and the first supporting member 121 is determined, the function of the limiting mechanism can be achieved, and therefore the locking principle is not described in detail.

The utility model provides an embodiment provides a sheath core subassembly for carrying intervene apparatus, including the core pipe, be fixed in the core pipe distal end and be used for connecting the latch fitting of intervene apparatus, sheath core subassembly still including the cover establish the accent return bend in the core pipe periphery, transfer the mutual fixed connection of both distal ends of return bend and core pipe, but both near-ends relative slip.

The sheath core assembly 400 comprises an inner and outer nested bend adjusting pipe 410 and a core pipe 425, the bend adjusting pipe 410 is wrapped outside the core pipe 425, the distal ends of the two are fixedly connected with each other, the proximal end can slide relatively, the proximal end of the bend adjusting pipe 410 is fixed on the second connecting piece 113, the proximal end of the core pipe 425 extends out of the second connecting piece 113 and then is fixed on the tail end, namely the proximal end side, of the second support body 111, and in order to facilitate butt joint with external pipe fittings, a pipe joint is installed at the proximal end of the core pipe 425, for example, a luer joint 118 mode is adopted.

When the interventional device needs to be released or retracted, the first driving member 122 is rotated to axially move the first connecting member 123, i.e., to drive the sheath 300 to move relative to the sheath core assembly 400. When bending needs to be adjusted, the second driving member 112 is rotated to axially move the second connecting member 113, i.e. to drive the proximal end of the bending tube 410 to move relative to the proximal end of the core tube 425.

Referring to fig. 5a to 11, the sheath core assembly 400 includes an adjustable bending tube 410 and a core tube assembly 420, wherein the core tube assembly 420 includes a core tube 425, a locking member 422 is installed at a distal end portion of the core tube 425 for connecting an interventional instrument, the adjustable bending tube 410 is sleeved on an outer periphery of the core tube 425, distal ends of the adjustable bending tube 410 and the core tube 425 are fixedly connected with each other, and proximal ends of the adjustable bending tube 410 and the core tube 425 can slide relatively.

The distal side of the elbow 410 extends to be adjacent to the proximal side of the locking element 422, the elbow 410 may be directly fixed to the core tube 425, or directly fixed to the proximal locking element 422, or both, and both the elbow 410 and the core tube 425 may be made of metal such as 304 stainless steel, and may be fixed by welding or fastening.

The distal end of core tube 425 further extends out of locking element 422 and is secured with guide head 421. The distal end of the guide head 421 has a rounded head structure with a convergent shape to facilitate the passing and advancing in the body, and the position between the guide head 421 and the locking element 422 is used as the loading position of the interventional device, and the interventional device in a compressed state is in the position and is in limit fit with the locking element 422.

In one embodiment, inner core 424 is threaded into barrel 425, the distal end of inner core 424 extends out of locking element 422 and is fixed with guide head 421, the extension length of the proximal end of inner core 424 is not limited strictly, the position at the periphery of inner core and between guide head and locking element is used as the loading position of the interventional device, the interventional device in the compressed state is in the position and is in limit fit with locking element 422, and the radial space of the loading position is expanded because inner core 424 has a smaller outer diameter relative to barrel 425 because barrel 425 does not extend to the loading position.

Referring to fig. 5a and 5b, in some embodiments, the locking element is a wire-controlled locking element, the interventional instrument 500 has a coupling lug 501 at a proximal end thereof, the coupling lug 501 generally has a hole or hook for threading a pull wire 4223, the locking element 422 has a locking hole 4221, the locking rod 4224 has a distal end engaged with the locking hole 4221, and a proximal end thereof extends to the operating handle.

In a loading state, the pull wire 4223 passes through the connecting lug 501 and then is sleeved on the lock rod 4224, the far end of the lock rod 4224 is inserted into the lock hole 4221, so that the pull wire 4223 can limit the connecting lug 501 from coming out of the lock piece 422, when release is needed, the lock rod 4224 is pulled towards the near end and comes out of the lock hole 4221, the pull wire 4223 is also released, and the connecting lug 501 is allowed to come out of the lock piece 422.

The number of the connecting lugs 501 is multiple, and a plurality of pull wires 4223 are arranged, each pull wire 4223 extends towards the far end through a wire distributing disc 4222, and a wire threading sleeve 4225 is sleeved on the periphery of the core tube 425 for arranging the wire harness so as to form an extending channel of the pull wire 4223.

The locking rods 4224 and the locking holes 4221 are used as a set of locking mechanism, and multiple sets of locking mechanisms can be arranged as required and are sequentially arranged along the circumferential direction of the locking piece 422.

Referring to fig. 5c, in some embodiments, the locking member 422 may be provided with 1 or more retaining grooves around its periphery, and the interventional device may have engaging lugs disposed in the retaining grooves, which may serve as axial retainers for the interventional device, allowing only radial expansion of the interventional device before release. In order to prevent the connecting lug from accidentally disengaging or suddenly tilting outwards to stab tissues when the connecting lug is released, pressing strips 423 matched with all limiting grooves are further fixed at the locking piece 422, the connecting lug is limited in the limiting grooves by the constraint of the sheath tube after the connecting lug is loaded, the safety is further improved, and the flexible pressing strips 423 are outwards turned outwards to allow the connecting lug to disengage from the locking piece 422 when the connecting lug is released.

Inner core 424 and core tube 425, both of tubular construction, do not require axial relative movement between core tube 425 and inner core 424, and therefore are nested and welded to one another, and may be provided with one or more weld attachment points. If necessary, a bush may be added to the welding portion to fill the radial gap between the core tube 425 and the inner core 424, and the inner core tube 425 and the bush may be welded to each other.

The plunger 425 is secured directly or indirectly to the proximal side of the locking element 422 at one end and extends toward the operating handle at the other end.

In one embodiment, to facilitate bending, the barrel 425 includes a compliant segment 4251 adjacent the locking element 422 and a third extension segment 4252 abutting and extending proximally from the compliant segment 4251.

In one embodiment, compliant segment 4251 is a hypotube having a length in the range of 120mm to 180mm, such as 150 mm.

The third extension 4252 is made of steel cable tubes (woven or twisted by metal wires); the steel cable pipe can be wrapped with a PTFE film to play a role in lubrication.

In other embodiments, core tube 425 is a full piece of hypotube. The hypotube can ensure axial supporting force and can be bent radially, in order to control the bending direction of the compliant section 4251, the compliant section 4251 can be provided with an axially extending reinforcing rib, and the reinforcing rib is obtained by cutting the corresponding part of the hypotube (the region which is not cut or has relatively sparse cutting marks is the reinforcing rib). The reinforcing ribs may extend to the proximal end of core tube 425 accordingly, but may also extend to the middle of core tube 425 or slightly proximal to the proximal end because core tube 425 does not have a significant bending requirement near the proximal end.

Referring to fig. 7, fig. 8, when compliant segment 4251 is cut, the cutting slit width (i.e., laser spot diameter): 0.1-1 mm, seam spacing: 0.1-1 mm; wherein an uncut portion extends in the axial direction to form a rib 4253.

In some embodiments, the core tube is the subject of the bend, and the compliant segment is configured to have a smaller extreme radius of curvature after the bend is made, the closer to the distal end. The distal end of the core tube may be made more adaptable to complex paths, particularly in terms of compliant segments, in at least one of the following ways, for example:

the slot width in the compliant segment varies gradually and the closer to the distal end, the larger the slot width.

The slot spacing varies gradually in the compliant section, with the slot spacing being greater the closer to the distal end.

In the compliant section, the stiffness (degree of flexibility) changes gradually, and the closer to the distal end, the lower the stiffness.

Referring to fig. 9 to 11, the bending adjusting tube 410 is sleeved outside the core tube 425, and the bending adjusting tube 410 sequentially includes a pulling section and a second extending section 413 from a distal end to a proximal end, wherein the pulling section is an integral structure and adopts a hypotube.

The distal side of the pulling member extends adjacent the proximal side of locking element 422 and is secured to core tube 425. In order to prevent the pulling section from being reversed during processing, different marks can be made at the two ends of the pulling section in a punching mode and the like so as to identify the assembly orientation of the far end and the near end.

The pulling section comprises a first pulling section 411, a transition section 414 and a second pulling section 412 in sequence from the distal end to the proximal end.

In the present application, the bending adjustment tube 410 is located outside the core tube 425, i.e. the active person applying force during bending adjustment is located outside, and the passive person under traction is located inside, so that the arrangement is relative to the active person, and the passive person can be allowed to obtain a larger bending angle outside.

The first pulling section 411 is formed with a rib 4111 by cutting, and the circumferential position of the rib 4111 is 180 degrees different from that of a rib 4253 of the compliant section 4251.

The second drawing segment 412 is also cut, and when the first drawing segment 411 and the second drawing segment 412 are cut, the width of the cutting seam is: 0.03-0.5 mm, seam spacing: 0.2 mm-0.85 mm; the first pulling section 411 is located at an expected bending position and is relatively soft and easy to bend, the second pulling section 412 is relatively hard, but in order to ensure certain flexibility, the first pulling section can be bent during transportation and packaging, and can be bent according to blood vessels after an operation enters a human body, so that a cutting mode is adopted, and the seam width and the seam interval can be correspondingly adjusted according to the hardness requirements of different sections during actual operation.

The second pulling section 412 has

ribs

4121 and 4122 cut out and diametrically opposed to each other, i.e., 180 degrees apart in circumferential position and 90 degrees apart from the ribs 4111 of the first pulling section 411 in circumferential position.

The transition section 414 is not cut, i.e. continuously extends in the circumferential direction, and the transition section 414 connects the first pulling section 411 and the second pulling section 412, and shares the pulling stress at different positions in the circumferential direction.

The second extension 413 has no special bending requirement and is mainly responsible for transmitting the pulling force, for example, by extending it proximally and connecting it to the operating handle, such as by using a hypotube that is not cut additionally.

The bending degree of the first drawing section 411 and the bending degree of the compliance section 4251 are large in the bending adjusting process, so that the bending adjusting angle is generally required to be larger than 270 degrees when the hypotube is cut, the single reinforcing rib structures arranged on the first drawing section 411 and the compliance section 4251 respectively ensure that the bending adjusting section and the compliance section are not stretched when the hypotube is subjected to bending stress, the softness is moderate after the first drawing section 411 and the compliance section 4251 are overlapped inside and outside, and the bending adjusting and the force transmission are easy to realize. Overall, the bend adjusting pipe 410 is 5mm to 10mm longer than the core pipe 425 to match the axial deviation after bend adjustment, the core pipe 425 and the sheath pipe 300 are both passive during bend adjustment, and the bend adjusting pipe 410 applies force actively.

Referring to fig. 12 to 13, in order to adapt to bending or to adaptively change the distal direction during passing through the body, the sheath 300 at the outermost layer has correspondingly different stiffness distributions at different axial positions, and the sheath 300 sequentially includes a loading section 310, a bending section 320 and a first extending section 330 from the distal end to the proximal end. In use, primarily bends proximal to the loading region that receives the interventional instrument 500, i.e., where the bending section 320 is located.

Referring to fig. 14 to 15d, in an embodiment, a nesting relationship among the sheath 300, the core tube assembly 420 and the adjusting tube 410 and a releasing process of the interventional instrument are illustrated, and in fig. 15d, a general axial position relationship among the sections of the sheath 300, the core tube assembly 420 and the adjusting tube 410 is also illustrated, for each section, the sheath 300 adopts a multi-layer composite structure, that is, for a certain section, the multi-layer structure and different parts are included in processing, and the structure and the process of the sheath 300 are also an improvement of the present application.

Referring to fig. 16 to 17d, in an embodiment, the nesting relationship of the sheath 300 and the core tube assembly 420 and the releasing process of the interventional instrument are illustrated, and in fig. 15d, the sheath 300 is also illustrated, and the approximate axial position relationship of the segments in the core tube assembly 420 is also illustrated, for each segment, the sheath 300 adopts a multi-layer composite structure, that is, for a certain segment, the multi-layer structure is adopted and different components are included in the processing, and the structure and the process of the sheath 300 are also one of the improvements of the present application. In this embodiment, core tube assembly 420 includes a core tube 425 having a locking element 422 secured to core tube 425, and a distal end of core tube 425 further extends beyond locking element 422 and has a guide head 421 secured at a distal end. The distal end of the guide head 421 has a rounded head structure with a convergent shape to facilitate the passing and advancing in the body, and the position between the guide head 421 and the locking element 422 is used as the loading position of the interventional device, and the interventional device in a compressed state is in the position and is in limit fit with the locking element 422.

In one embodiment, core tube 425 has core 424 threaded therein, the distal end of core 424 extends out of locking element 422 and is fixed with guide head 421, the distal end of core tube 425 extends only to locking element 422, the proximal extension of core 424 is not limited, and core 424 has a smaller outer diameter relative to core tube 425 because core tube 425 does not extend to the loading position, so that the radial space of the loading position can be expanded.

The distal end of the sheath is a loading section 310 with an expanded diameter for accommodating an interventional instrument, the loading section 310 adopts a multilayer structure and sequentially comprises an inner lining tube 375, a metal tube and an outer coating 380 from inside to outside, wherein the metal tube comprises a main tube 350 and a head end tube 340 which are butted with each other from a proximal end to a distal end;

the head tube 340 includes a body section 346, a plurality of expansion tabs 344 spaced circumferentially apart on a distal side of the body section, a first connector 343 on a proximal side of the body section, the distal side of the body tube 350 carrying a second connector 351, the first connector 343 and the second connector 351 being interfitting and complementary in shape.

An embodiment of the present application provides a sheath for delivering an interventional device, the sheath is divided into a loading section 310, a bending section 320 and a first extending section 330 from a distal end to a proximal end in sequence in an axial direction, wherein the loading section 310 is used for accommodating the interventional device 500, the sheath adopts a multilayer structure, including: the inner sheath tubes 370, the inner sheath tubes 370 are distributed on the bending section and the first extending section in the axial direction;

an inner lining tube 375, wherein the inner lining tube 375 is butted against the distal end of the inner sheath tube 370, and the inner lining tube 375 is distributed on the loading section in the axial direction;

the metal pipe wraps the distal end part of the inner sheath pipe and the periphery of the inner lining pipe, and is distributed on the bending section and the loading section in the axial direction;

and the outer wrapping film 380 wraps the periphery of the metal pipe, and the outer wrapping film 380 is distributed on the bending section and the loading section in the axial direction.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application.

Claims

1. The operating handle is used for conveying an interventional instrument to a human body and is characterized by being used for connecting the near ends of three pipe fittings which are nested inside and outside in sequence and driving the near ends of the three pipe fittings to move relative to each other, the three pipe fittings respectively comprise a core pipe, a bend adjusting pipe and a sheath pipe from inside to outside, and the operating handle comprises a control assembly, a bend adjusting assembly and a front end handle;

the control assembly includes:

a first support fixed to the front end handle;

a first connector slidably mounted to the first support, the proximal end of the sheath being secured to the first connector;

the bend adjustment assembly comprises:

a second support fixed opposite to the first support;

the second connecting piece is slidably mounted on the second support body, and the near end of the bend adjusting pipe penetrates through the sheath pipe and then is fixed on the second connecting piece;

2. The manipulating handle for delivering an interventional instrument to a human body as claimed in claim 1, wherein the first driving member is rotatably sleeved on the outer circumference of the first supporting body, and a limiting mechanism for limiting a rotation angle of the first driving member is disposed between the front end handle and the first driving member.

3. The manipulating handle for delivering an interventional instrument to a human body according to claim 2, wherein the limiting mechanism comprises:

a slide key mounted to one of the front end handle and the first driver;

4. The manipulating handle for delivering an interventional instrument to a human body as claimed in claim 3, wherein the outer wall of the front end handle is formed with a sliding slot, the sliding key is installed in the sliding slot, and the locking hole is formed on an axial end surface of the first driving member.

5. The manipulating handle for delivering an interventional instrument to a human body according to claim 2, wherein the limiting mechanism comprises a locking pin threadedly mounted on the first driving member and abutting against the first supporting body.

6. The manipulating handle for delivering an interventional instrument to a human body according to claim 1, wherein the first supporting body is cylindrical, a guide bar hole extending along an axial direction is formed in a side wall of the first supporting body, the first connecting member is slidably mounted inside the first supporting body, a guide key extending out of the guide bar hole along a radial direction is formed in the first connecting member, and a threaded structure matched with the guide key is formed in an inner wall of the first driving member.

7. The manipulating handle for delivering an interventional instrument to a human body according to claim 1, wherein the second supporting body is cylindrical and disposed coaxially with the first supporting body, and the second supporting body and the first supporting body are fixed together by an integral structure or a separate structure.

8. The manipulating handle for delivering an interventional instrument to a human body according to claim 1, wherein the second driving member is rotatably mounted relative to the second supporting body, the second supporting body defines an operation opening, a portion of the second driving member is disposed inside the second supporting body, and at least a portion of the second driving member is exposed to the operation opening as a force applying portion, and the second connecting member is disposed inside the second supporting body and is linked with the second driving member.

9. The manipulating handle for delivering an interventional instrument to a human body according to claim 1, wherein the second driving member is internally threaded, at least a portion of the second coupling member is externally threaded and extends into the second driving member, and the second driving member threadedly drives the second coupling member to slide.

10. The manipulating handle for delivering an interventional instrument to a human body according to claim 1, wherein an inner wall of the second supporting body is provided with a guide bar extending in an axial direction, at least a portion of the second connecting member is located in the second supporting body and an outer wall of the portion is provided with a guide groove engaged with the guide bar.