WO2021136210A1

WO2021136210A1 - Removal device

Info

Publication number: WO2021136210A1
Application number: PCT/CN2020/140403
Authority: WO
Inventors: 王永胜; 高国庆; 梁良军
Original assignee: 杭州诺茂医疗科技有限公司
Priority date: 2019-12-30
Filing date: 2020-12-28
Publication date: 2021-07-08

Abstract

A removal device (100), used for removing a slender structure implanted in a body. The removal device (100) comprises a control handle (20), a sheath (50) connected to the distal end of the control handle (20), and an expansion head (80) connected to the distal end of the sheath (50). The control handle (20) comprises a driving member and a rotating member connected to the driving member. During the movement of the driving member to the proximal end, the driving member is used for driving the rotating member to rotate in a direction, and the rotating member drives the sheath (50) and the expansion head (80) to move synchronously. Because the control handle (20) can drive the rotating member to drive the sheath (50) and the expansion head (80) to rotate synchronously, the expansion head (80) can effectively cut the fibrous tissue wrapped around the slender structure, so that the slender structure in the body of a patient can be removed conveniently, safely and smoothly.

Description

Take out the device

Technical field

This application relates to the technical field of interventional medical devices, and in particular to a device for taking out electrode leads implanted in a patient's body for a long time.

Background technique

Various medical treatments and surgical procedures require the implantation of elongated structures in the bodies of human or livestock patients. Such elongated structures can include catheters, sheaths, cardiac electrode leads (such as pacemaker leads or defibrillator leads), and a variety of other devices. Among them, the pacemaker is usually implanted in the subcutaneous tissue pocket in the chest wall of the patient, and the multiple wires of the pacemaker extend from the pacemaker to the chamber of the patient's heart through the vein; the defibrillator wires can be fixed inside the heart Or external.

In some cases, it is necessary to remove the wires implanted in the patient's body. For example, the wires implanted in the patient's body are disconnected and cannot transmit signals, and a large number of fibrous (or calcified) tissues are formed at the electrode tips, which makes the pacemaker unable to provide enough Energy to run, infection at the wire site, clot or scar tissue blocking the vein, or other malfunctions. However, due to the long time of implanting the slender structure into the patient’s body, there will be many fibers (or calcified) tissue attached to the lead, so that between multiple leads, between the lead and the wall of the blood vessel, or between the lead and the inner wall of the heart At the same time, the wire cannot be taken out directly. Forcible removal will cause problems such as wire breakage, damage to the surrounding wire, and damage to the blood vessel wall or the inner wall of the heart.

Summary of the invention

In view of this, the present application provides an extraction device for extracting an elongated structure implanted in the body. The extraction device includes a control handle, a sheath connected to the distal end of the control handle, and The expansion head of the distal end of the sheath, the control handle includes a driving part and a rotating part connected to the driving part, and the driving part is used to drive the rotating part along the proximal end of the driving part. When rotating in one direction, the rotating member drives the sheath tube and the expansion head to make a synchronous movement.

The control handle of the extraction device of the present application can drive the expansion head and the sheath to move in the patient's blood vessel, and the control handle can control the driving part to drive the rotating part to rotate, and the rotation of the rotation part can drive the sheath and the expansion head to rotate synchronously . When the proximal end of the elongated structure (such as a wire) passes through the threading lumen and passes through the extraction device from the control handle to extend to the outside of the body, the expansion head and sheath are advanced in the blood vessel to the distal end to cut and wrap the The fibrous tissue surrounding the elongated structure separates the elongated structure from the inner wall of the blood vessel. Since the control handle can drive the sheath tube and the expansion head to rotate synchronously by driving the rotating member, the expansion head can effectively cut the fibrous tissue wrapped around the slender structure, and it is convenient to safely and smoothly take out the slender structure in the patient.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present application more clearly, the following will briefly introduce the drawings that need to be used in the embodiments. Obviously, the drawings in the following description are some embodiments of the present application, which are common in the field. As far as technical personnel are concerned, they can also obtain other drawings based on these drawings without creative work.

Fig. 1 is a schematic structural diagram of a take-out device provided by one of the embodiments of the present application.

Fig. 2 is a schematic cross-sectional view of the take-out device in Fig. 1 along the line II-II.

Fig. 3 is a partial cross-sectional enlarged view of the take-out device in Fig. 2.

Fig. 4 is an exploded schematic view of the three-dimensional structure of the worm, worm gear assembly and inner sheath tube joint in Fig. 2.

Fig. 5 is an enlarged schematic diagram of the worm in Fig. 4.

Fig. 6 is an enlarged schematic view of the inner sheath tube joint in Fig. 4.

Fig. 7 is an enlarged schematic view of the joint of the worm gear assembly and the inner sheath tube in Fig. 4.

Fig. 8 is a cross-sectional view of the worm gear assembly, worm and inner sheath tube joint of Fig. 4 after assembly.

Fig. 9 is a schematic cross-sectional view of the take-out device in Fig. 1 along line VIII-VIII.

Fig. 10 is an enlarged partial cross-sectional view of Fig. 9.

Fig. 11 is a schematic diagram of a state of the take-out device in Fig. 10.

Fig. 12 is a schematic cross-sectional structural view of the extracting device in Fig. 9 in use.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In addition, the description of the following embodiments refers to the attached drawings to illustrate specific embodiments that can be implemented in the present application. The directional terms mentioned in this application, for example, "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., only Refers to the direction of the attached illustration. Therefore, the direction terms used are for a better and clearer description and understanding of this application, rather than indicating or implying that the device or element referred to must have a specific orientation or a specific orientation. The structure and operation cannot therefore be understood as a limitation of this application. "The connection between the component A and the component B" means that the component A is directly connected to the component B, or the component A is indirectly connected to the component B through other components.

In order to describe the structure of the retrieval device more clearly, the limited terms "proximal", "distal" and "axial" described in this application are commonly used terms in the field of interventional medicine. Specifically, "distal" refers to the end far away from the operator during the surgical operation; "proximal end" refers to the end close to the operator during the surgical operation; "axial" refers to the direction of the central axis of the device, and the radial is the same as the center. The direction in which the axis is perpendicular. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by those skilled in the technical field of this application. Conventional terms used in the specification of this application are only for the purpose of describing specific embodiments, and should not be construed as limiting the application.

1 and FIG. 2, the present application provides a retrieval device 100, which is used to peel off the body tissue attached around the elongated structure (as shown in FIG. 11) implanted in the body, and remove the elongated structure in the body . The elongated structure can be a cardiac wire, a nerve pacing and stimulation wire, a catheter, a sheath, a sleeve, and other tubular similar objects. For the sake of convenience, the following description takes the lead 500 with a slender structure as a pacemaker as an example. The distal end of the lead 500 is also connected with electrodes fixed on the heart. It should be understood that the extraction device 100 can be used to extract at least the other elongated structures described above.

The extraction device 100 includes a control handle 20, a sheath 50 connected to the distal end of the control handle 20, and an expansion head 80 connected to the distal end of the sheath 50; wherein the control handle 20, the sheath 50 and the expansion head 80 are taken out along the The axial direction of the device 100 is provided with a threading lumen 201 for transmitting the wire 500. The wire 500 is used to sequentially pass through the dilation head 80, the sheath 50, and the threading lumen 201 in the manipulation handle 20 to extend from the proximal end of the extraction device 100 . The control handle 20 is used to control the rotation of the sheath 50 and the expansion head 80. Specifically, the control handle 20 includes a driving part and a rotating part connected to the driving part. The end of the sheath tube 50 away from the expansion head 80 is connected to the rotating part. During the proximal movement of the driving part, the driving part is used for The rotating member is driven to rotate in one direction, so that the rotating member drives the sheath 50 and the expansion head 80 to make a synchronous movement. The distal end of the expansion head 80 has a knife edge for cutting the fibrous tissue wrapped around the guidewire 500, so as to cut through or otherwise break obstacles encountered during the removal of the guidewire 500. The one-direction rotation means that when the driving member moves toward the proximal end, the driving member does not drive the rotating member to change the direction of rotation.

When using the extraction device 100, the doctor inserts the proximal end (the end close to the doctor) of the guide wire 500 in the patient into the expansion head 80. The doctor grasps the control handle 20 and pushes the control handle 20 to the distal end (the end away from the doctor), so that the sheath 50 and the expansion head 80 gradually enter the patient's blood vessel along the electrode lead. When the resistance of pushing the control handle 20 to the distal end is large, it means that the expansion head 80 is in contact with the tissue surrounding the wire 500, and the driving member is controlled by the control handle 20 to drive the rotating member to rotate. The rotation energy of the rotating member is The sheath 50 and the expansion head 80 are driven to rotate synchronously, so that the sharp blade of the expansion head 80 cuts the tissue around the electrode lead to separate the lead from the tissue to facilitate subsequent removal of the electrode lead.

The control handle 20 of the retrieval device 100 of the present application can drive the expansion head 80 and the sheath 50 to move within the patient's blood vessel, and the control handle 20 can control the driving member to drive the rotating member to rotate, and the rotation of the rotating member can drive the sheath 50 And the expansion head 80 rotates synchronously. When the proximal end of the guide wire 500 passes through the threading lumen 201 from the control handle 20 to pass through the extraction device 100 to extend to the outside of the body, the expansion head 80 and the sheath 50 are advanced distally in the blood vessel to cut the wrapped around the guide wire 500 Fibrous tissue separates the guide wire 500 from the inner wall of the blood vessel. Since the control handle 20 can drive the sheath 50 and the expansion head 80 to rotate synchronously by driving the rotating member, the expansion head 80 can effectively cut the fibrous tissue wrapped around the guide wire 500, and it is convenient to safely and smoothly take out the guide wire 500 from the patient's body. .

As shown in FIG. 2, the control handle 20 also includes a housing 21. As shown in FIG. 2, the housing 21 has a tubular structure with a closed proximal end. A fishtail-shaped end block 210 is provided at the proximal end of the housing 21. The fishtail-shaped end block 210 can increase the contact area with the surgeon’s fingers. Easy to operate. A receiving groove 211 is provided in the housing 21 along the axial direction. The distal end of the receiving groove 211 penetrates the distal surface of the housing 21, and the proximal end of the receiving groove 211 extends into the end block 210 without passing through the proximal surface of the end block 210 . The driving member and the rotating member are accommodated in the receiving groove 211, and the proximal end of the sheath tube 50 is inserted into the receiving groove 211 from the distal end of the housing 21 and then connected to the rotating member.

The manipulation handle 20 further includes an operating member 26 slidably arranged in the housing 21 along the axial direction, and the operating member 26 is connected to the proximal end of the driving member. The proximal end of the sheath 50 is connected to the rotating member, and the operating member 26 controls the driving member to drive the rotating member to rotate, so as to drive the sheath 50 and the expansion head 80 to rotate synchronously.

As shown in Figure 2, the driving member is axially provided with a threading slot 2301 communicating with the inner cavity of the sheath 50, and the proximal end of the wire 500 passes through the expansion head 80, the threading lumen 201 in the sheath 50, and the driver in turn. The threading through slot 2301 of the piece is then threaded out of the housing 21, so that the operator, such as a surgeon, can take out the wire after peeling the fibrous tissue from the control handle 20.

In this embodiment, the driving member includes a worm 23, which is slidably arranged in the receiving groove 211 of the housing 21 along the axial direction; the rotating member includes a worm wheel 25, which is sleeved on the periphery of the worm 23, and the sheath The proximal end of the tube 50 is inserted into the receiving groove 211 from the distal opening of the housing 21 and then connected to the worm wheel 25. The worm 23 slides in the axial direction to drive the worm wheel 25 and the sheath 50 to rotate. The sheath tube 50 includes an inner sheath tube connector 52 connected to the worm wheel 25 and an inner sheath tube 54 connected to the distal end of the inner sheath tube connector 52. The end of the inner sheath tube connector 52 away from the inner sheath tube 54 is connected to the worm wheel 25. When using the extraction device 100, the proximal end of the guide wire 500 passes through the expansion head 80, the lumen of the inner sheath 54, the threading lumen 201 of the inner sheath connector 52, the threading slot 2301 of the driver, and the housing 21 in the axial direction. After the inner cavity, it passes through the outer shell 21.

2 and 3, the inner wall of the housing 21 is provided with a first limiting portion 212, the first limiting portion 212 is used to cooperate with the inner sheath tube connector 52 to limit the inner sheath tube connector 52 in the axial direction The range of motion makes the inner sheath tube joint 52 unable to move back and forth in the axial direction. Under the action of the first limiting portion 212, the inner sheath tube joint 52 can rotate around the axis of the extraction device 100.

Specifically, the first limiting portion 212 includes a pair of first limiting ribs 213 arranged on the inner wall of the housing 21 at intervals, a rotating groove 214 is enclosed between the pair of first limiting ribs 213, and the inner sheath tube joint 52 A first annular plate 522 is protruded from the outer peripheral surface corresponding to the rotating groove 214. The first annular plate 522 is used to be accommodated in the rotating groove 214. The first annular plate 522 and the first limiting rib 213 face the inner sheath in the axial direction. The joint 52 is restricted.

The inner wall of the housing 21 is further provided with a second limiting portion, and the second limiting portion is used to cooperate with the worm wheel 25 to limit the worm wheel 25 in the axial direction. In this embodiment, the second limiting portion is specifically a second annular plate 217 protruding from the inner wall of the housing 21 and extending in the circumferential direction. The outer peripheral surface of the worm wheel 25 defines an annular groove 252 in the circumferential direction corresponding to the second annular plate 217. The second annular plate 217 is rotatably received in the annular groove 252. The second annular plate 217 faces the worm wheel 25 in the axial and radial directions. Limit the position so that the worm wheel 25 can only rotate on the axis of the worm wheel 25.

In other embodiments, the inner wall of the housing 21 is provided with an annular groove along the circumferential direction, and the outer circumferential surface of the worm wheel 25 is provided with an annular plate corresponding to the annular groove, and the annular plate is rotatably received in the annular groove, so The annular plate restricts the worm wheel 25 in the axial and radial directions, so that the worm wheel 25 can only rotate on the axis of the worm wheel 25. It can be understood that, without violating the principle of the present application, the specific technical solutions of the first limiting portion 212 and the second limiting portion can be used in common. In the modified embodiment, the first limiting portion 212 and the second limiting portion can be used in common. The second limiting part can also use other technical solutions to limit the inner sheath tube joint 52 and the worm gear 25 respectively.

The inner wall of the receiving slot 211 of the housing 21 is provided with a third limiting portion 218 for limiting the driving element. Specifically, the third limiting portion 218 is an annular plate provided on the inner wall of the housing 21 and is located at the proximal end of the second annular plate 217. The third limiting portion 218 is used for limiting the driving member in the radial direction of the extraction device 100. Further, the third limiting portion 218 defines a circular through hole along the axial direction, and the worm 23 is slidably inserted into the through hole of the third limiting portion 218 along the axial direction. 23 coincides with the axis line, the inner diameter of the through hole of the third limiting portion 218 is slightly larger than the outer diameter of the worm 23, so as to limit the worm 23 in the radial direction of the extraction device 100, so that the worm 23 can surround the extraction device 100 Axial rotation.

As shown in FIG. 2, the proximal end of the housing 21 near the end block 210 is provided with a guide groove 219 communicating with the receiving groove 211 along the axial direction. A part of the operating member 26 is accommodated in the housing 21, and the other part extends through the guide groove 219 to the housing. In addition to 21, the length of the guide groove 219 in the axial direction is long enough to enable the operating member 26 to slide along the guide groove 219. The proximal end of the worm 23 is fixedly connected to the operating member 26, and sliding of the operating member 26 along the guide groove 219 can drive the worm 23 to slide in the axial direction. In this embodiment, two opposite guide grooves 219 are provided on the housing 21. The operating member 26 includes a connecting portion 261 connected to the proximal end of the worm 23 and a handle 263 provided on opposite sides of the connecting portion 261. The connecting portion 261 can be along the axis. The two handles 263 are slidably received in the receiving groove 211, and the two handles 263 extend through the guide groove 219 to the outside of the housing 21. Pulling the two handles 263 toward the proximal end drives the connecting portion 261 to slide along the guide groove 219, and the sliding of the connecting portion 261 drives the worm 23 to slide.

As shown in FIG. 8, the side wall of the housing 21 is provided with an outlet hole 2101 connected to the threading slot 2301. After the proximal end of the wire 500 passes through the opening of the threading slot 2301, it extends out of the extraction device 100 through the threading hole 2101. That is, after the proximal end of the wire 500 passes through the threading lumen 201 of the expansion head 80, the threading lumen 201 of the sheath tube 50, and the threading through slot 2301 of the driver, it extends out of the housing 21 from the outlet hole 2101 of the housing 21. The outlet hole 2101 is close to the proximal end of the operating member 26.

The end of the worm 23 close to the operating member 26 is axially opened with an opening 2303 communicating with the threading through slot 2301, and the proximal end of the wire 500 extends to the outlet hole 2101 through the opening 2303. The opening 2303 is provided on the outer surface of the worm 23. The housing 21 has a guide portion 2105 extending obliquely into the opening 2303 at the proximal end of the outlet hole 2101. The proximal end of the wire 500 in the opening 2303 slides along the guide portion 2105 and then passes through the outlet hole 2101. . The inner surface of the end opening 2303 of the guide portion 2105. When the worm 23 slides toward the proximal end in the axial direction, the guide portion 2105 slides relative to the inner surface of the opening 2303. In an embodiment, there is no gap between the guide portion 2105 and the inner surface of the opening 2303, which does not block the proximal end of the wire 500, and facilitates the proximal end of the wire 500 to pass through the outlet hole 2101 along the guide portion 2105.

4 to 6 together, the worm 23 includes a cylindrical rod body 230, a one-way spiral groove 231 is provided on the outer peripheral surface of the rod body 230, and the one-way spiral groove 231 rotates and extends in one direction. In the present application As shown in Fig. 4, viewed from the proximal end to the distal end, the one-way spiral groove 231 extends in a clockwise rotation around the axial direction. It can be understood that the one-way spiral groove 231 can also rotate in a counterclockwise direction around the axial direction. extend.

The worm wheel 25 defines a through hole 251 for penetrating the rod body 230 along the axial direction. The inner peripheral surface (the surface facing the through hole 251) of the worm wheel 25 is protrudingly provided with a sliding guide pin 254 for being accommodated in the one-way spiral groove 231. When the worm 23 moves in the through hole 251 in the axial direction, the guide pin 254 slides in the one-way spiral groove 231 to drive the worm wheel 25 to rotate.

As shown in Figure 5, the one-way spiral groove 231 refers to a spiral groove extending in one direction on the outer surface of the rod 230, and the distal end of the one-way spiral groove 231 extends to the distal surface of the rod 230, that is, one-way The spiral groove 231 is formed with an opening on the distal end surface of the rod body 230.

In other embodiments, the guide sliding pin 254 may also be arranged at other positions on the worm wheel 25, such as facing the surface of the inner sheath tube connector 52. The sliding through hole 256 may also be a circular through hole, an elliptical through hole, a trapezoidal through hole, a parallelogram through hole, a polygonal through hole, or an irregular through hole. The end of the guide sliding pin 254 may have a smooth transition.

As shown in FIG. 6, in this embodiment, in order to balance the force of the worm wheel 25, the number of the guide sliding pins 254 is two, and the two guide sliding pins 254 are arranged oppositely on the inner wall of the through hole 251 of the worm wheel 25, that is, two The guide sliding pin 254 is located at the same axial position of the worm wheel 25. Two guide sliding pins 254 are slidably inserted in the one-way spiral groove 231 of the worm 23.

Further, a connecting post 235 is provided at the proximal end of the rod body 230, and the connecting post 235 is used to fix the connecting operating member 26 so that the rod body 230 can follow the operating member 26 to slide in the inner cavity of the housing 21 in the axial direction. Specifically, the connecting post 235 and the operating element 26 can be fixedly connected by means of clamping or screw fixing; the connecting post 235 and the operating element 26 can also be connected by other conventional connection methods known in the art. The threading through groove 2301 penetrates the rod body 230 along the axial direction of the worm 23, and the opening 2303 is located between the one-way spiral groove 231 and the connecting column 235.

In other embodiments, the one-way spiral groove 231 may also be provided on the inner peripheral surface of the worm wheel 25, that is, the one-way spiral groove 231 is provided on the inner peripheral surface of the through hole 251 facing the worm wheel 25, and the guide sliding pin 254 is convexly provided On the outer peripheral surface of the worm 23; in the process of the worm 23 sliding in the through hole 251 in the axial direction, the sliding guide pin 254 slides in the one-way spiral groove 231 to drive the worm wheel 25 to rotate.

As shown in FIG. 6, the worm wheel 25 has a circular ring structure, a circular through hole 251 is formed in the middle of the worm wheel 25 in the axial direction, and an annular groove 252 is formed on the outer peripheral surface of the worm wheel 25 in the circumferential direction. The distal surface of the worm wheel 25 defines a receiving hole 255 around the through hole 251 (as shown in FIG. 3 ), and the proximal end of the sheath tube 50 is rotatably received in the receiving hole 255.

Specifically, the proximal end of the inner sheath tube connector 52 is rotatably received in the receiving hole 255. The proximal end of the inner sheath tube connector 52 is rotatably received in the receiving hole 255. Specifically, the proximal end of the inner sheath tube connector 52 and the worm wheel 25 can be fixedly connected by means of clamping or bonding.

The proximal end surface of the worm wheel 25 defines a sliding guide through hole 256 along the axial direction. The proximal end of the guide sliding through hole 256 passes through the proximal surface of the worm wheel 25, and the distal end of the guide sliding through hole 256 communicates with the receiving hole 255. In this embodiment, the proximal surface of the worm wheel 25 is provided with two square guiding and sliding through holes 256 opposite to each other, that is, the two guiding sliding through holes 256 are symmetrical about the axis of the worm wheel 25. A positioning hole 2561 and a convex setting post 2563 are respectively provided on the proximal surface of the worm wheel 25 on opposite sides of each sliding through hole 256.

As shown in FIG. 2, FIG. 4 and FIG. 6, the control handle 20 further includes a one-way limiting component 28. The one-way limiting component 28 is disposed on the worm wheel 25 and rotates in an axial direction synchronously following the worm wheel 25. The one-way limiting component 28 includes a limiting rod 281, a first elastic member 283, a locking member 286, and a positioning cover 285 with an inner cavity.

The limit rod 281 includes a resisting portion 2811 inserted in the sliding through hole 256 in the axial direction, a stop portion 2812 disposed at the proximal end of the resisting portion 2811, and an extension protruding from the proximal end of the stop portion 2812 in the axial direction部2814. When the abutting portion 2811 is inserted into the sliding through hole 256 and the stop portion 2812 is attached to the proximal surface of the worm wheel 25, the distal end of the abutting portion 2811 extends into the receiving hole 255 (FIG. 3 ). The first elastic member 283 is used to push the limiting rod 281 to move to the distal end, so that the limiting rod 281 abuts against the proximal end of the sheath 50, that is, the first elastic member 283 pushes the stopping portion 2812 to drive the abutting portion 2811 along The guide sliding through hole 256 slides to the distal end and abuts against the proximal end of the sheath 50 until the stop portion 2812 is attached to the proximal surface of the worm wheel 25.

In this embodiment, the first elastic member 283 is a spring sleeved on the extension portion 2814 of the limiting rod 281. The positioning cover 285 is buckled on the surface of the worm wheel 25. In this embodiment, it is buckled on the proximal surface of the worm wheel 25. The proximal end of the positioning cover 285 is provided with a sliding hole 2852 communicating with its inner cavity along the axial direction. The extension portion 2814 and the stop portion 2812 of the limit rod 281 can be accommodated in the inner cavity of the positioning cover 285, and the extension portion 2814 can be inserted into the sliding hole 2852. The first elastic member 283 is sleeved on the periphery of the extension portion 2814, and opposite ends of the first elastic member 283 abut against the inner wall of the stop portion 2812 and the positioning cover 285, respectively. The distal end of the positioning cover 285 is provided with a connecting plate 2854 protruding radially outwards, and the connecting plate 2854 is provided with two positioning holes along the axial direction; in this embodiment, the distal end of the positioning cover 285 is provided with two connecting plates 2854.

In this embodiment, in order to balance the force on the proximal end surface of the worm wheel 25, and to make the limit rod 281 more stable in the limit of the inner sheath tube joint 52, the control handle 20 includes two unidirectional limit components 28, two The limit rods 281 of the one-way limit component 28 correspond to the two guide sliding through holes 256 of the worm wheel 25 respectively.

The proximal end of the sheath tube 50 is provided with an engaging portion 523. Specifically, the proximal end of the inner sheath tube connector 52 is provided with an engaging portion 523. The engaging portion 523 includes a rack 5230. The limit rod 281 of the one-way limit component 28 abuts against the meshing portion 523 in the axial direction. When the worm 23 is sliding proximally, the distal end of the limit rod 281 is clamped to the rack, so that the sheath 50 follows the worm wheel. 25 makes a synchronous movement; when the worm 23 slides distally, the distal end of the stopper 281 slides on the surface of the engaging portion 523, and the worm wheel 25 rotates relative to the sheath 50, that is, the sheath 50 does not rotate with the worm wheel 25.

Specifically, the inner sheath tube connector 52 includes a tube body 521 whose proximal end is inserted into the receiving hole 255 of the worm wheel 25. The first annular plate 522 is protruded from the proximal end adjacent to the tube body 521 along the circumferential direction of the tube body 521. The body 521 is accommodated in the receiving hole 255 of the worm wheel 25 at the proximal end of the first annular plate 522; the engaging portion 523 is disposed on the proximal end surface of the tube body 521. The first elastic member 283 is used for elastically pressing against the limiting rod 281 in the axial direction, so that the abutting portion 2811 of the limiting rod 281 is clamped to the engaging portion 523. In this embodiment, the meshing portion 523 cooperates with the one-way limiting component 28 to limit the sheath tube 50 to synchronize with the worm wheel 25 during the rotation of the worm wheel 25 in the first direction (the worm 23 moves toward the proximal end). The rotation in the second direction (the worm 23 moves to the distal end) does not follow the rotation of the worm wheel 25, and the first direction is opposite to the second direction.

In this embodiment, the rack 5230 includes a plurality of first surfaces 5231 and at least one second surface 5233 disposed toward the limiting rod 281. Each second surface 5233 is connected between the two first surfaces 5231. The included angle between 5231 and the axis pointing to the proximal end is the first included angle, and the included angle between the second surface 5233 and the axis pointing to the proximal end is the second included angle, and the first included angle is greater than the second included angle. That is, the first surface 5231 is relatively smooth, and the second surface 5233 is relatively steep. The connection between the first surface 5231 and the second surface 5233 (the proximal boundary of the second surface 5233) forms a saw tooth 5234. A depression 5236 is formed at the distal boundary.

In the process of the worm 23 sliding proximally, the distal end of the limiting rod 281 moves from the distal end of the second surface 5233 to the proximal end of the second surface 5233, thereby engaging in the recess 5236 and abutting against the second surface 5233 , That is, the limiting rod 281 is clamped to the rack, the limiting rod 281 rotates along the axial direction of the worm wheel 25, and drives the meshing portion 523 and the sheath 50 to perform synchronous movement.

In the process of sliding the worm 23 to the distal end, the distal end surface of the limiting rod 281 slides over a first surface 5231, then passes over the proximal and distal ends of a second surface 5233 in turn, and then slides to the adjacent first surface 5233. On a surface 5231, the distal end of the limiting rod 281 continues to slide on the proximal surface of the engaging portion 523 without abutting against the second surface 5233. The limiting rod 281 and the worm wheel 25 rotate relative to the sheath 50, namely The limiting rod 281 slips on the proximal surface of the inner sheath tube joint 52.

Since the first surface 5231 has a slope with respect to the axial direction, the distance between the first surface 5231 and the proximal end of the retrieval device 100 at different positions in the circumferential direction is different, and the limit rod 281 spans from a first surface 5231 to the same. During the process of adjoining the first surface 5231, the distance between the distal end of the limiting rod 281 and the proximal end of the retrieval device 100 may also vary.

When the worm 23 slides to the distal end, the abutting portion 2811 slides over the multiple first surfaces 5231, and the angles between the multiple first surfaces 5231 and the axial direction may be the same or different. Each first surface 5231 sequentially pushes the abutting portion 2811 to compress the first elastic member 283. When the abutting portion 2811 slides to the distal end of the first surface 5231, the stop portion 2812 compresses the first elastic member 283 to a small extent, and the abutting portion 2811 When sliding to the proximal end of the first surface 5231, the stop portion 2812 compresses the first elastic member 283 to a greater extent.

In the modified embodiment, the proximal surface of the engaging portion 523 further includes other surfaces other than the first surface 5231 and the second surface 5233, such as a plane perpendicular to the axis.

As shown in Fig. 3, in the process of sliding the worm 23 to the distal end, in order to ensure that the sheath 50 remains stationary with respect to the outer shell 21 of the control handle 20, the control handle 20 is also provided with a damping member 27. The damping member 27 is disposed between the proximal end of the sheath tube 50 and the housing 21, and further, the side surface of the damping member 27 close to the axis contacts the inner sheath joint 52, thereby generating damping for preventing the inner sheath joint 52 from rotating.

Specifically, in this embodiment, the damping member 27 has a ring shape. It is understood that the damping member 27 may also have a strip shape, a spherical shape, or other shapes.

The inner wall of the housing 21 is protrudingly provided with a second limiting rib 215 adjacent to a pair of first limiting ribs 213, and an annular positioning groove 216 is enclosed between the second limiting rib 215 and the adjacent first limiting rib 213 , The positioning slot 216 is used for positioning the damping member 27. Specifically, the second limiting rib 215 is adjacent to the first limiting rib 213 at the distal end, and the axial width of the positioning groove 216 is slightly smaller than the diameter of the positioning damping member 27, so that the damping member 27 is positioned in the positioning groove 216 .

As shown in FIG. 2, in this embodiment, the inner sheath tube connector 52 and the inner sheath tube 54 are fixed by a screw connection. Specifically, the distal end of the inner sheath tube connector 52 is provided with internal threads, and the inner sheath tube 54 is close to The end is provided with an external thread, and the internal thread and the external thread are assembled in place and fixed with thread glue, so that the inner sheath tube connector 52 and the inner sheath tube 54 are fixed together. The inner sheath tube connector 52 and the inner sheath tube 54 can also be fixed in other ways, such as welding.

Please refer to Figures 4-7 together. When assembling the worm 23, the worm wheel 25, the inner sheath tube joint 52 and the one-way limiting component 28, first assemble each one-way limiting component 28 to the inner sheath tube joint 52. Ground, the first elastic member 283 of each one-way limiting component 28 is sleeved on the extension portion 2814 of the limiting rod 281, and the first elastic member 283, the extension portion 2814, and the stop portion 2812 are accommodated in the positioning cover 285 The extension part 2814 is inserted into the sliding hole 2852, and the limiting part 2811 of the limiting rod 281 is inserted into the guiding sliding through hole 256, so that the positioning posts 2563 on both sides of each guiding sliding through hole 256 are inserted into the positioning cover 285 Of the two corresponding positioning holes, the two locking members 286 respectively pass through the positioning cover 285 and the other two positioning holes are locked in the two positioning holes 2561 corresponding to the inner sheath tube connector 52 to limit the two unidirectional positions. The assembly 28 is installed on the worm wheel 25; the worm wheel 25 is rotatably sleeved outside the rod body 230, specifically, the guide pin 254 of the worm wheel 25 is slidably inserted into the one-way spiral groove 231 from the distal end of the rod body 230; The proximal end of the sheath connector 52 is inserted into the accommodating hole 255 of the worm wheel 25; at this time, the first elastic member 283 elastically pushes the limit rod 281 so that the limit part 2811 and the engaging part 523 are clamped with each other; the distal end of the rod body 230 is inserted into The inner cavity of the sheath joint 52 drives the rotating member to rotate relative to the worm 23. As shown in Figure 2, a second elastic member 265 is provided between the housing 21 and the operating member 26. The second elastic member 265 moves synchronously with the worm 23. When the worm 23 moves proximally, the second elastic member 265 is compressed and compressed. Deformation occurs; the elastic restoring force generated by the second elastic member 265 is used to push the worm 23 to move distally. Specifically, the second elastic member 265 is received in the receiving groove 211 of the housing 21, and opposite ends of the second elastic member 265 are respectively connected to the proximal end of the connecting portion 261 of the operating member 26 and the inner end block 210 of the housing 21. surface. The operating member 26 is used to receive external pulling force to drive the worm 23 and the second elastic member 265 to slide proximally along the axial direction; when the external pulling force disappears, the elastic restoring force generated by the second elastic member 265 pushes the operating member 26 and the worm 23 to Remote movement. In this embodiment, the second elastic member 265 is a spring.

An end of the second elastic member 265 close to the operating member 26 is sheathed with a tubular sheath 267. The length of the sheath 267 extending in the axial direction is greater than the length of the guide groove 219 extending in the axial direction. The distal end of the second elastic member 265 is along the axis. The direction can be compressed or stretched within the sheath 267. The distal end of the sheath 267 is clamped between the distal end of the second elastic element 265 and the proximal end of the operating element 26. The sheath 267 slides with the operating element 26. The sheath 267 can prevent the second elastic element 265 from deforming in the radial direction. Enter into the guide groove 219 or extend through the guide groove 219 to the outside of the housing 21.

As shown in Figures 2, Figures 3-8, the assembled worm wheel 25, worm 23, limit assembly 28 and inner sheath tube joint 52 are installed in the housing 21. Specifically, the connecting post 235 of the worm 23 is connected to At the distal end of the connecting portion 261 of the operating member 26, the third limiting portion 218 supports the worm 23 so that the worm 23 can slide in the axial direction; the guide portion 2105 is slidably inserted into the opening 2303; the worm wheel 25 is received in the housing 21 In the receiving groove 211, the second annular plate 217 of the housing 21 is rotatably accommodated in the annular groove 252 of the worm wheel 25; the second limiting rib 215 supports the tube body 521 of the inner sheath tube joint 52 and the first part of the inner sheath tube joint 52. An annular plate 522 is rotatably received in the rotating groove 214, and the damping member 27 is sleeved on the outer peripheral surface of the inner sheath tube joint 52. The proximal end of the sheath tube 50 is fixedly connected to the distal end of the inner sheath tube connector 52 by a screw connection. At this time, the inner cavity of the sheath tube 50, the threading slot 2301 of the worm 23, and the outlet hole 2101 of the housing 21 communicate with each other to form Thread the inner cavity 201 to facilitate the insertion of the wire 500.

As shown in Figures 2 and 8, the distal end of the housing 21 is provided with a hollow soft glue nozzle 2107, and the sheath tube 50 passes through the soft glue nozzle 2107; the distal end of the sheath tube 50 is sheathed with an outer sheath 55, The proximal end of the sheath 55 is inserted into the soft glue nozzle 2107.

Please refer to FIGS. 2 to 3, 8, 9 and 11 together. During the specific operation of taking out the device 100, the doctor inserts the lead 500 in the patient, such as the proximal end of the electrode lead, into the expansion head 80; the doctor grasps Hold the control handle 20 and push the control handle 20 to the distal end, so that the sheath 50 and the expansion head 80 gradually enter the patient's blood vessel along the electrode lead; when the resistance of pushing the control handle 20 to the distal end is greater, it is explained The expansion head 80 is in contact with the tissue around the guide wire 500, and the operating member 26 is pulled to the proximal end to drive the worm 23 to slide in the axial direction toward the proximal end. The first elastic member 283 elastically pushes the limit rod 281 to make the abutting portion 2811 and the sheath The engaging portion 523 of the tube 50 is clamped. The worm 23 slides toward the proximal end, and the inner surface of the one-way spiral groove 231 slidably pushes the guide pin 254 of the worm wheel 25 to drive the worm wheel 25 to rotate; because the worm wheel 25 is clamped with the inner sheath tube joint 52 through the limit rod 281, Therefore, the worm gear 25 drives the inner sheath tube connector 52, the sheath tube 50, and the expansion head 80 to rotate in the same direction, so that the sharp blade of the expansion head 80 cuts the tissue around the guide wire 500; until the operating member 26 is along the guide groove 219 Slide to the proximal end until the connecting portion 261 abuts against the proximal end of the guide groove 219. The worm wheel 25 rotates to the distal end of the one-way spiral groove 231 of the worm 23, and the second elastic member 265 is compressed and elastically deformed.

During the entire process of pulling the operating member 26 toward the proximal end, the worm 23 drives the worm wheel 25 and the sheath 50 to rotate in the same direction, so that the expansion head 80 can effectively cut the fibrous tissue wrapped around the wire 500. The proximal end of the wire 500 passes through the casing 21 along the threading lumen 201, that is, the proximal end of the wire 500 passes through the expansion head 80, the lumen of the sheath 50, and the threading slot 2301 of the driver in turn, and then passes through the guide portion 2105 from the housing 21. The outlet hole 2101 passes through.

Please refer to Figure 2, Figure 3, Figure 8, Figure 10-11, when the tension on the control handle 20 is released, that is, the control handle 20 is released, and the elastic force generated by the second elastic member 265 pushes the operating member 26 to the distal end to drive it. The worm 23 slides toward the distal end in the axial direction, the worm wheel 25 rotates, and the distal end of the limit rod 281 slides on the surface of the engaging portion 523, and the damping member 27 prevents the inner sheath tube joint 52 from rotating together with the limit rod 281. Therefore, the worm wheel 25 rotates relative to the sheath tube 50, that is, the limiting rod 281 is not clamped with the inner sheath tube joint 52, and the sheath tube 50 will not rotate with the worm wheel 25. Therefore, the load during the rebound of the second elastic member 265 is reduced, which is beneficial to the smooth sliding of the worm wheel 25 from the distal end to the proximal end of the unidirectional spiral groove 231. When the operating member 26 slides along the guide groove 219 to the proximal surface of the abutting guide groove 219, the first elastic member 283 elastically pushes against the limiting rod 281, so that the abutting portion 2811 is engaged with the engaging portion 523 of the sheath 50, thereby The second elastic member 265, the operating member 26, and the driving member return to the initial position, which is convenient for the user to pull the control handle 20 toward the proximal end again.

In other embodiments, the one-way limiting component 28 and the engagement portion 523 of the sheath tube 50 are omitted from the worm wheel 25, the worm wheel 25 is connected to the inner sheath tube connector 52, and the proximal end of the inner sheath tube connector 52 is fixedly connected to the distal end of the worm wheel 25. The end, or the inner sheath tube joint 52 and the worm wheel 25 are an integral structure. When the worm 23 is sliding toward the proximal end, the worm 23 drives the worm wheel 25 and the sheath 50 to rotate in the first rotation direction; when the worm 23 is sliding toward the distal end, the worm 23 drives the worm wheel 25 and the sheath 50 along the second rotation direction. The rotation direction rotates, and the first rotation direction is opposite to the second rotation direction.

Specifically, the operating member 26 is pulled to the proximal end to drive the worm 23 to slide proximally, and the inner surface of the one-way spiral groove 231 slidably abuts and pushes the guide pin 254 of the worm wheel 25 to drive the worm wheel 25, the sheath 50 and the expansion head 80 rotates in the first direction, so that the sharp blade of the expansion head 80 cuts the tissue around the wire 500; when the pulling force on the control handle 20 is released, the second elastic member 265 elastically resets and pushes the operating member 26 distally The worm 23 is driven to slide toward the distal end in the axial direction, and the inner surface of the one-way spiral groove 231 slides against and pushes the guide pin 254 of the worm wheel 25, so that the worm wheel 25 drives the inner sheath joint 52, the sheath 50 and the expansion head 80 along the first Rotating in two directions enables the expansion head 80 to effectively cut the fibrous tissue wrapped around the wire 500.

It should be noted that, without departing from the principle of the embodiments of the present application, the specific technical solutions in the above embodiments may be mutually applicable.

The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the embodiments of the present application, several improvements and modifications can be made, and these improvements and modifications are also Treated as the scope of protection of this application.

Claims

A take-out device is used to take out a slender structure implanted in the body. The take-out device includes a control handle, a sheath connected to the distal end of the control handle, and an expansion head connected to the distal end of the sheath, It is characterized in that, the control handle includes a driving part and a rotating part connected to the driving part, and the driving part is used to drive the rotating part to rotate in one direction during the proximal movement of the driving part, The rotating member drives the sheath tube and the expansion head to make a synchronous movement.
The extraction device according to claim 1, wherein:

The driving member includes a worm, an outer peripheral surface of the worm is provided with a one-way spiral groove, and the one-way spiral groove rotates and extends in one direction;

The rotating member includes a worm wheel, the worm wheel is provided with a through hole along the axial direction for piercing the worm, and the inner peripheral surface of the worm wheel is convexly provided with a guide pin for being accommodated in the one-way spiral groove In the process of the worm sliding in the through hole in the axial direction, the guide sliding pin slides in the one-way spiral groove to drive the worm wheel to rotate.
The extraction device according to claim 2, wherein:

The control handle further includes a one-way limiting component disposed on the worm gear, and the one-way limiting component rotates synchronously following the worm gear;

When the worm is sliding toward the proximal end, the one-way limiting component and the proximal end of the sheath tube are clamped with each other, so that the sheath tube follows the worm wheel to move synchronously;

When the worm is sliding distally, the distal end of the one-way limiting component is used to slide on the proximal surface of the sheath, and the worm wheel rotates relative to the sheath.
The retrieval device according to claim 3, wherein the sheath tube includes an engaging portion with a rack provided at the proximal end thereof, and the unidirectional limiting component includes an axially abutting against the engaging portion Limit rod,

When the worm is sliding toward the proximal end, the distal end of the limiting rod is clamped to the rack;

In the process of the worm sliding distally, the distal end of the limiting rod slides on the surface of the engaging portion.
The extraction device according to claim 4, wherein the rack includes a plurality of first surfaces and at least one second surface disposed toward the limit rod, and each second surface is connected to one of the two first surfaces. In between, the included angle between the first surface and the axis pointing to the proximal end is a first included angle, and the included angle between the second surface and the axis pointing to the proximal end is a second included angle, and the first The included angle is greater than the second included angle;

When the worm is sliding toward the proximal end, the distal end of the limiting rod moves from the distal end of the second surface to the proximal end of the second surface, so as to abut against the second surface, so that The limiting rod is clamped to the rack, and the limiting rod rotates along the axial direction of the worm wheel and drives the sheath to make a synchronous movement;

In the process of sliding the worm to the distal end, after the distal end surface of the limit rod slides over a first surface, it passes over the proximal and distal ends of a second surface in turn, and then slides to the adjacent first surface. On a surface, so that the distal end of the limiting rod continues to slide on the proximal surface of the engaging portion, the limiting rod and the worm wheel rotate relative to the sheath.
The extraction device according to claim 5, wherein the worm wheel is provided with a guide sliding through hole along the axial direction, and the limiting rod includes an abutment portion for passing through the guide sliding through hole to abut against the meshing portion , The one-way limiting component further includes a first elastic member with elasticity disposed at the proximal end of the abutting portion, and the first surface sequentially pushes the abutting portion in the process of the worm sliding toward the distal end Compress the first elastic member.
The retrieval device according to claim 6, wherein the one-way limiting component further includes a positioning cover with an inner cavity that is buckled on the surface of the worm gear, and the limiting rod further includes a An extension portion at the proximal end of the extension portion, the extension portion and the first elastic member are accommodated in the inner cavity of the positioning cover, and the first elastic member is sleeved on the periphery of the extension portion.
The retrieval device according to any one of claims 3-7, wherein the control handle further comprises a housing and a damping member, and the proximal end of the sheath, the driving member, and the rotating member are all accommodated In the housing, the damping member is disposed between the proximal end of the sheath tube and the housing, so as to dampen the sheath tube during the rotation of the sheath tube relative to the housing.
The retrieval device according to claim 2, wherein the proximal end of the control handle is provided with a second elastic member that moves synchronously with the worm; when the worm moves toward the proximal end, the second elastic member Is compressed and deformed; the elastic restoring force generated by the second elastic member is used to push the worm to move distally.
The retrieval device according to claim 9, wherein the control handle further comprises an operating member connected between the worm and the second elastic member, and the operating member is used to receive an external pulling force to drive the The worm and the second elastic member slide toward the proximal end in the axial direction. After the external pulling force disappears, the elastic restoring force generated by the second elastic member pushes the operating member and the worm to move distally.
The retrieval device according to claim 2, wherein the control handle further comprises a housing, and the proximal end of the sheath, the driving member, and the rotating member are all accommodated in the housing, and the The sheath tube includes an inner sheath tube connector and an inner sheath tube, and the inner sheath tube is connected between the inner sheath tube connector and the expansion head;

The inner wall of the housing is provided with a first limiting portion, and the first limiting portion is used to cooperate with the inner sheath tube connector to limit the axial movement range of the inner sheath tube connector; and/or

The inner wall of the housing is provided with a second limiting portion, and the second limiting portion is used for cooperating with the worm wheel to limit the worm wheel in the axial direction.
The extraction device according to claim 2, wherein the proximal end of the sheath tube is connected to the worm wheel and moves synchronously with the worm wheel, and when the worm is sliding toward the proximal end, the worm is Drive the worm wheel and the sheath tube to rotate in a first rotation direction; when the worm is sliding distally, the worm drives the worm wheel and the sheath tube to rotate in a second rotation direction, and the first A rotation direction is opposite to the second rotation direction.