阅读说明：本技术 隧穿工具 (Tunneling tool ) 是由 王晓凯 唐龙军 何庆 徐永强 吴曦 于 2020-06-30 设计创作，主要内容包括：本发明涉及一种隧穿工具,用于建立皮下隧道,以将电极经皮下隧道引出,包括：手柄；造隧端子；造隧杆,近端连接所述手柄,远端可拆卸地连接所述造隧端子；连接件,设置在所述造隧杆的远端,用于与电极可拆卸的连接；以及造隧管,可拆卸地套设在所述造隧杆上,且所述造隧管被配置为相对于所述造隧杆在轴向上被限制移动。在实施时,所述隧穿工具能够兼容不同的皮下隧穿方式,以较方便地满足不同医生的操作习惯,使手术操作更为灵活和方便,而且通过造隧杆牵引电极的方式,也使皮下隧穿操作更快捷,手术时间更短。(The invention relates to a tunneling tool for establishing a subcutaneous tunnel to lead out an electrode from the subcutaneous tunnel, comprising: a handle; a tunneling terminal; the near end of the tunnel making rod is connected with the handle, and the far end of the tunnel making rod is detachably connected with the tunnel making terminal; the connecting piece is arranged at the far end of the tunnel making rod and is used for being detachably connected with the electrode; and a tunnel making pipe detachably sleeved on the tunnel making rod, wherein the tunnel making pipe is configured to be limited to move in the axial direction relative to the tunnel making rod. When the tunneling tool is used, the tunneling tool can be compatible with different subcutaneous tunneling modes so as to conveniently meet the operation habits of different doctors, so that the operation is more flexible and convenient, and the subcutaneous tunneling operation is faster and the operation time is shorter in a mode of drawing the electrode through the tunneling rod.)

1. A tunneling tool for creating a subcutaneous tunnel for extracting an electrode from the subcutaneous tunnel, comprising:

a handle;

a tunneling terminal;

the near end of the tunnel making rod is connected with the handle, and the far end of the tunnel making rod is detachably connected with the tunnel making terminal;

the connecting piece is arranged at the far end of the tunneling rod and is used for being detachably connected with the electrode; and the number of the first and second groups,

make the tunnel pipe, detachably cover establish make on the tunnel pole, just make the tunnel pipe be configured as for make the tunnel pole in the axial by the restriction removal.

2. The tunneling tool of claim 1, wherein the tunneling terminal is snap-fit connected to the tunneling rod.

3. The tunneling tool of claim 2, wherein the tunneling terminal is also magnetically connected with the tunneling rod.

4. The tunneling tool according to claim 2, wherein a slot is provided at a proximal end of the tunneling terminal, a protrusion matching with the slot is provided at a distal end of the tunneling rod, and the tunneling rod and the tunneling terminal are locked by the protrusion and the slot.

5. The tunneling tool according to claim 4, wherein a cavity is formed at a proximal end of the tunneling terminal, the slot is disposed on an inner wall of the cavity, and a protrusion matching with the slot is disposed on an outer surface of a distal end of the tunneling rod; when the far end of the tunnel making rod is inserted into the cavity, the protrusion is matched and locked with the clamping groove.

6. The tunneling tool of claim 5, wherein the number of the protrusions is at least two, and the protrusions are symmetrically arranged along the circumference of the tunneling rod, and each protrusion is locked with a corresponding one of the slots.

7. The tunneling tool of any one of claims 1-6, wherein the proximal end of the tunneling terminal has an outer surface dimension that is greater than an outer surface dimension of the distal end of the tunneling tube.

8. The tunneling tool of any one of claims 1-6, wherein the connector is configured to grip the electrode by elastic deformation.

9. The tunneling tool of claim 8, wherein the distal end of the tunneling rod is provided with a mounting slot, and the connector comprises a tube, at least a portion of the tube being disposed within the mounting slot; the tube is made of an elastic material, and the inner surface of the tube has a size smaller than the outer surface of the electrode.

10. The tunneling tool of claim 9, wherein the tubing is glued to the tunneling rod.

11. The tunneling tool of claim 9, wherein the entire tube is disposed within the mounting slot.

12. The tunneling tool of claim 8, wherein the connector comprises a socket disposed at a distal end of the tunneling rod and an elastomer secured within the socket, the elastomer having an inner surface that is smaller in size than an outer surface of the electrode.

13. A tunneling tool as claimed in claim 12, wherein the elastomer comprises at least one elastic ring or several circumferentially distributed elastic bumps.

14. The tunneling tool of any one of claims 1-6, wherein the cross-sectional area of the handle is greater than the cross-sectional area of the tunneling shaft.

15. The tunneling tool of claim 14, wherein the tunneling rod is a circular rod, the outer diameter of the tunneling rod being 3.2mm to 3.4 mm; the cross section of the handle has width and length, the length of the handle is 70 mm-90 mm, the width of the handle is 16 mm-20 mm, and the thickness of the handle is 14 mm-16 mm.

16. The tunneling tool of claim 14, wherein the handle is an open structure.

17. The tunneling tool of claim 14, wherein the side of the handle facing the tunneling shaft has an arcuate surface that is concave in a direction away from the tunneling shaft; or one side of the handle, which is back to the tunnel making rod, is provided with an arc surface which is bulged towards the direction of the tunnel making rod.

18. The tunneling tool according to any one of claims 1-6, wherein a proximal stop is provided on a side of the handle facing the tunneling shaft, the proximal stop being connected to a proximal end of the tunneling shaft; the outer surface size of the proximal end limiting part is larger than that of the proximal end of the tunneling tube.

19. The tunneling tool of claim 18, wherein the proximal stop is adhesively bonded or injection molded with the tunnel making rod.

20. The tunneling tool of claim 18, wherein the tunneling tube is a circular tube having an inner diameter of 3.5mm to 3.8mm and a thickness of 0.2mm to 0.4 mm; the near-end limiting part is a circular cylinder, the diameter of the circular cylinder is 6.0-8.0 mm, and the height of the circular cylinder is 4.0-6.0 mm.

21. A tunneling tool according to any one of claims 1-6, wherein the handle is made of a medical polymer material, and the tunneling tube is a composite tube containing a mesh grid.

22. The tunneling tool of any one of claims 1-6, wherein the tunneling terminal has a smooth head.

Technical Field

The invention relates to the technical field of medical instruments, in particular to a tunneling tool for an electrode.

Background

Parkinson's Disease (PD) is a common degenerative Disease of the nervous system, and the average age of the Disease is about 60 years, which is common to the elderly. The most important pathological change of Parkinson's disease is the degenerative death of mesencephalic nigral Dopamine (DA) neurons, which causes a marked reduction in striatal DA content and causes disease. Parkinson's disease mainly presents with resting tremor, bradykinesia, gait disturbance of posture and the like, which can cause great influence on the life of patients.

With the development of modern medical science and technology, the Parkinson's disease can be effectively improved by stimulating the subthalamic nucleus or the internal nucleus of the globus pallidus by using the electrodes. The Deep Brain Stimulation (DBS) system used is shown in fig. 1 and includes a pulse generator (generally abbreviated as IPG)1, an extension lead 2 and an electrode 3. The electrode 3 is generally implanted into the brain by about 10cm, the rest of the electrode is embedded under the skin of the head, the other end of the electrode is placed behind the ear and connected with a subcutaneous extension lead 2, and the extension lead 2 is connected with the pulse generator 1. The pulse generator 1 generates an electrical signal that is transmitted to the electrodes 3 via the subcutaneous extension leads 2 to the target area of the brain. If a patient has symptoms of resting tremor, gait disturbance, etc. on one side of the body (only the left or right side of the body), it is usually necessary to implant 1 pulse generator, 1 extension lead 2 and 1 electrode 3. If the patient's symptoms appear bilaterally, it is usually necessary to implant 1 pulse generator, 2 extension leads 2, 4 and 2 electrodes 3, 5, as shown in fig. 1.

When the unilateral electrode is implanted subcutaneously, the implantation process is as follows: an electrode tunneling tool is used for entering from a cranial incision, tunneling along the lower part of the scalp and penetrating out of the ear to construct a subcutaneous tunnel, so that the electrode is led to the lower part of the ear along the subcutaneous tunnel. When the bilateral electrode is implanted subcutaneously, the implantation process is as follows: the left and right cranial incision are tunneled subcutaneously by using an electrode tunneling tool, the left electrode firstly walks to the right side and then subcutaneously tunnels along the right cranial incision, and then penetrates out of the back of the ear, and 2 electrodes are wired to the back of the ear along the subcutaneous tunnel. The electrode tunneling tool is used by a doctor in an operation, and the common operation mode is as follows: the tunnel making tube is left under the scalp after puncture, the electrode makes the tunnel along the tunnel making tube, and then the tunnel making tube is withdrawn. It can be seen that the electrode tunneling tool itself needs to be convenient to hold, have certain rigidity, and have the functions of subcutaneous puncture and subcutaneous routing.

However, such a manipulation manner of the tunneling tube is not convenient enough and cannot meet the use habits of different doctors. Not only here, the size of the handheld piece of electrode tunneling instrument near-end is less, and usually by the integrative bending of stainless steel's rod, and the diameter of rod is less (about 3.2 mm), and in order to guarantee the intensity of handheld part, the size of the circle of buckling is also little, is not convenient for the doctor to hand, and the comfort level of handing is also low. In addition, the tunnel terminal of making of tunnel instrument distal end is fixed for screw-thread fit, and complex operation when screwing off and making the tunnel terminal take off and make the tunnel pipe has increased the operation time.

Disclosure of Invention

The invention aims to provide a tunneling tool to solve one or more problems that an existing electrode tunneling tool is inconvenient to operate, cannot meet use habits of different doctors, is inconvenient for a doctor to hold, is low in hand-holding comfort level, and is long in operation time.

In order to achieve the above object, the present invention provides a tunneling tool for establishing a subcutaneous tunnel to lead out an electrode through the subcutaneous tunnel, the tunneling tool comprising:

a handle;

a tunneling terminal;

the near end of the tunnel making rod is connected with the handle, and the far end of the tunnel making rod is detachably connected with the tunnel making terminal;

the connecting piece is arranged at the far end of the tunnel making rod and is used for being detachably connected with the electrode; and the number of the first and second groups,

make the tunnel pipe, detachably cover establish make on the tunnel pole, just make the tunnel pipe be configured as for make the tunnel pole in the axial by the restriction removal.

Optionally, make the tunnel terminal with make tunnel pole buckle connection.

Optionally, the tunnel making terminal is magnetically connected with the tunnel making rod.

Optionally, the near-end of making the tunnel terminal is provided with the draw-in groove, the distal end of making the tunnel pole be provided with draw-in groove assorted arch, make the tunnel pole with it passes through to make the tunnel terminal protruding with the draw-in groove cooperation is locked.

Optionally, a cavity is formed at the proximal end of the tunneling terminal, the slot is disposed on the inner wall of the cavity, and a protrusion matched with the slot is disposed on the outer surface of the distal end of the tunneling rod; when the far end of the tunnel making rod is inserted into the cavity, the protrusion is matched and locked with the clamping groove.

Optionally, the number of the protrusions is at least two, the protrusions are symmetrically arranged along the circumferential direction of the tunnel making rod, and each protrusion is matched and locked with one corresponding clamping groove.

Optionally, the proximal end of the tunneling terminal has an outer surface dimension greater than an outer surface dimension of the distal end of the tunneling tube.

Optionally, the connector is configured to clamp the electrode by elastic deformation.

Optionally, a mounting groove is formed at a distal end of the tunnel making rod, the connecting member includes a pipe, and at least a part of the pipe is disposed in the mounting groove; the tube is made of an elastic material, and the inner surface of the tube has a size smaller than the outer surface of the electrode.

Optionally, the pipe fitting is bonded with the tunnel making rod by glue.

Optionally, the whole pipe fitting is arranged in the mounting groove.

Optionally, the connecting piece comprises a slot and an elastic body; the slot is arranged at the far end of the tunnel making rod, the elastic body is fixed in the slot, the elastic body is provided with an inner surface, and the size of the inner surface is smaller than that of the outer surface of the electrode.

Optionally, the elastic body includes at least one elastic ring or a plurality of circumferentially distributed elastic protrusions.

Optionally, the area of the cross section of the handle is larger than the area of the cross section of the tunneling rod.

Optionally, the tunnel making rod is a circular rod, and the outer diameter of the tunnel making rod is 3.2 mm-3.4 mm; the cross section of the handle has width and length, the length of the handle is 70 mm-90 mm, the width of the handle is 16 mm-20 mm, and the thickness of the handle is 14 mm-16 mm.

Optionally, the handle is an open structure.

Optionally, one side of the handle facing the tunnel making rod is provided with an arc surface which is concave towards the direction away from the tunnel making rod; or one side of the handle, which is back to the tunnel making rod, is provided with an arc surface which is bulged towards the direction of the tunnel making rod.

Optionally, a near-end limiting part is arranged on one side of the handle facing the tunnel making rod, and the near-end limiting part is connected with the near end of the tunnel making rod; the outer surface size of the proximal end limiting part is larger than that of the proximal end of the tunneling tube.

Optionally, the near-end limiting part is connected with the tunnel making rod through glue bonding or injection molding

Optionally, the tunnel making pipe is a circular pipe fitting, the inner diameter of the tunnel making pipe is 3.5 mm-3.8 mm, and the thickness of the tunnel making pipe is 0.2 mm-0.4 mm; the near-end limiting part is a circular cylinder, the diameter of the circular cylinder is 6.0-8.0 mm, and the height of the circular cylinder is 4.0-6.0 mm.

Optionally, the handle is made of a medical polymer material, and the tunnel making pipe is a composite pipe containing a woven mesh.

Optionally, the tunneling terminal has a smooth head.

In the tunneling tool provided by the invention, the tunneling tool can complete subcutaneous tunneling of the electrode along the tunneling tube tunneling electrode and can also complete subcutaneous tunneling of the electrode in a way of dragging the electrode by the tunneling rod, so that the same tunneling tool can meet the use habits of different doctors, the subcutaneous tunneling of the electrode is more convenient, the operation is more flexible, and the way of dragging and pulling out the electrode by the tunneling rod is simpler and faster, so that the operation time can be obviously shortened, and the operation efficiency is improved.

In the tunneling tool provided by the invention, the tunneling terminal is in buckle connection with the tunneling rod, and preferably, the tunneling terminal and the tunneling rod are in magnetic connection.

In the tunneling tool provided by the invention, the size of the outer surface of the proximal end of the tunneling terminal is larger than that of the outer surface of the distal end of the tunneling tube, in addition, one side of the handle facing the tunneling rod is provided with the proximal end limiting part, the proximal end limiting part is connected with the proximal end of the tunneling rod, and the size of the outer surface of the proximal end limiting part is larger than that of the outer surface of the proximal end of the tunneling tube.

In the tunneling tool provided by the invention, the area of the cross section of the handle is larger than that of the cross section of the tunneling rod, so that a doctor can conveniently hold the tunneling tool, and the holding comfort level is good.

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. In the drawings:

fig. 1 is a diagram of an application scenario of a DBS system implantation when patient symptoms appear bilateral in the prior art;

FIG. 2 is a schematic structural view of a tunneling tool in a preferred embodiment of the present invention;

FIG. 3 is an axial cross-sectional view of the distal end of the tunneling tool in a preferred embodiment of the present invention;

FIG. 4 is a schematic view of the structure of the handle in the preferred embodiment of the present invention;

FIG. 5 is a schematic view of the distal end of the tunneling tool in accordance with the preferred embodiment of the present invention;

FIGS. 6(a) through 6(f) are schematic illustrations of the use of a tunneling tool through a tunneling electrode of a tunneling tube in a preferred embodiment of the present invention;

figures 7(a) to 7(e) are schematic diagrams of the use of a tunneling tool to pull an electrode through a tunneling rod in a preferred embodiment of the present invention.

The labels in the figure are:

a pulse generator 1; extension leads 2, 4; electrodes 3, 5;

a tunneling tool 100; a handle 10; a tunnel making rod 20; a tunneling tube 30; a tunneling terminal 40; a tube 50;

a proximal end stopper 101; a mounting groove 201; a protrusion 202; a card slot 401; a head portion 41; a tail portion 42; the patient's scalp 200.

The same reference numbers in the drawings identify the same or similar elements.

Detailed Description

To make the objects, advantages and features of the present invention more apparent, the present invention will be described in further detail below with reference to specific drawings and examples. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. As used in this specification, the term "proximal" generally refers to the end of the instrument near the operator, and "distal" generally refers to the end of the instrument that enters the body first. Furthermore, in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without one or more of these specific details. In other instances, well-known features have not been described in order to avoid obscuring the invention. 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 be present, including but not limited to mechanical, electrical, or communicative connections.

The core idea of the invention is to provide a tunneling tool to construct a subcutaneous tunnel by using the tunneling tool to tunnel along the subcutaneous tunnel, so that the electrode is led out along the subcutaneous tunnel. That is, the tunneling tool of the present invention is mainly an electrode tunneling tool, but the electrodes that are suitable for use may be DBS electrodes (i.e., brain deep stimulation electrodes), SCS electrodes (i.e., spinal nerve stimulation electrodes), or other types of electrodes, and the specific kind of the electrodes is not limited.

The tunneling tool proposed by the present invention is further described with reference to the drawings and the preferred embodiments.

Figure 2 is a schematic diagram of the tunneling tool in a preferred embodiment of the present invention. As shown in fig. 2, the tunneling tool 100 provided in the present embodiment includes a handle 10, a tunneling rod 20, a tunneling tube 30, and a tunneling terminal 40. The far end of the tunnel making rod 20 is detachably connected with the tunnel making terminal 40, and the near end of the tunnel making rod 20 is fixedly connected with the handle 10. The fixed connection mode between the tunnel making rod 20 and the handle 10 can be a non-detachable fixed connection mode or a detachable fixed connection mode. If the tunnel making rod 20 is detachably and fixedly connected with the handle 10, the connection mode includes but is not limited to a threaded connection, a snap connection, and the like. The tunnel making rod 20 is fixedly connected with the handle 10 in a non-detachable manner, and the connection manner includes but is not limited to glue bonding, welding or injection molding connection. Preferably, make tunnel pole 20 and handle 10 through injection moulding's mode fixed connection, joint strength is good, is convenient for the doctor to the propelling movement in the art.

Make tunnel pipe 30 detachably cover establish on making tunnel pole 20, just it is configured to be for making tunnel pole 20 in the axial by the restriction removal to make tunnel pipe 30, avoids making tunnel pipe 30 to drop on the one hand, and on the other hand guarantees the accuracy of making the position of tunnel pipe 30. In this embodiment, the two ends of the tunnel-making tube 30 are provided with a limiting structure to prevent the tunnel-making tube 30 from moving towards the proximal end or the distal end. Preferably, make the tunnel pipe 30 spacing by making the distal end of tunnel terminal 40 at making tunnel pole 20 to make tunnel pipe 30 spacing by handle 10 at the near-end of making tunnel pole 20, do so, the structure is simpler, it is convenient to make, low in manufacturing cost.

The tunneling tool 100 further comprises a connector disposed at the distal end of the tunneling shaft 20 for detachable connection with the electrode 3 (see fig. 6 and 7). It will be appreciated that the connector is selectively used, for example when using the tunneling tube 30 for subcutaneous tunneling, the connector need not be connected to the electrode 3, and when using the tunneling rod 20 to pull the electrode 3, the connector need be connected to the electrode 3. The connection between the connector and the electrode 3 is detachable, and the connection between the connector and the electrode 3 is not particularly limited in the present invention. Further, in order to facilitate the assembly and disassembly of the electrode 3 and protect the electrode 3, the connecting piece is preferably sleeved on the electrode 3 in an elastic deformation manner to clamp the electrode 3, and such a design can effectively ensure that the electrode 3 cannot be separated when the electrode 3 is pulled, has high reliability, and cannot damage the electrode 3 in the plugging and unplugging process. It should be understood that the proximal end of the electrode 3 usually has a plug, and the electrode plug can be directly connected with the connecting piece, so that the use is convenient. In this embodiment, the connector includes a tube 50 (see fig. 3) sleeved on the electrode 3, and the tube 50 is elastically deformed to clamp the electrode 3.

Figure 3 is an axial cross-sectional view of the distal end of the tunneling tool in a preferred embodiment of the present invention. As shown in fig. 3, the connecting member is a pipe member 50, and a mounting groove 201 is formed at a distal end of the tunnel making rod 20, and the pipe member 50 is installed into the mounting groove 201 from an opening at the distal end of the mounting groove 201 and is fixed. Moreover, the tube 50 is made of a soft material, specifically, an elastic material, including but not limited to silica gel, polyurethane, etc., so that the tube 50 clamps the electrode 3 by using its own elastic deformation capability to fix the electrode 3. More specifically, the inner surface dimension (i.e., inner bore diameter) of the tube 50 is smaller than the outer surface dimension (i.e., outer diameter) of the electrode 3. For example, the external diameter of current electrode 3 is 1.3mm, at this moment, the hole of pipe fitting 50 is the circular port, the aperture of circular port be less than 1.3mm can, for example the hole diameter of pipe fitting 50 is 1.2mm, can press from both sides tight electrode 3 through the deformation of material when electrode 3 inserts the hole, prevent that electrode 3 from droing, utilize less power to extract electrode 3 when taking off electrode 3 moreover.

The pipe 50 is limited to move in the axial direction relative to the tunneling rod 20, and at least a part of the pipe 50 is fixed in the installation groove 201, and the fixing manner of the two is not limited. Further, preferably, the pipe 50 is bonded in the mounting groove 201 through glue, so that the process is simple, the cost is low, and the connection strength is good. The length of the pipe member 50 generally corresponds to the axial depth of the mounting groove 201, and the entire pipe member 50 is disposed in the mounting groove 201, that is, the pipe member 50 is not exposed to the outside. It should be understood that the axial depth of the mounting groove 201 should not be too large or too small; if the axial depth of the mounting groove 201 is too large, the structural strength of the tunnel making rod 20 is easily reduced, the bonding difficulty of the pipe fitting 50 is increased, and meanwhile, the plugging and unplugging of the electrode 3 are not convenient due to the overlong pipe fitting 50; if the axial depth of the installation groove 201 is too small, the connection strength between the pipe 50 and the electrode 3 cannot be effectively ensured due to too short pipe; based on these considerations, the inventor designs the length of the pipe fitting 50 to be 50mm to 60mm, which not only can ensure the strength of the tunnel making rod 20, but also can reduce the bonding difficulty of the pipe fitting 50, is convenient for plugging and unplugging the electrode 3, and can ensure that the electrode 3 does not fall off.

In an alternative embodiment, the tube 50 may be eliminated, and a socket is directly formed at the distal end of the tunneling rod 20, and an elastic body is disposed in the socket to clamp and lock the electrode 3 through the elastic body, so as to fix the electrode 3. That is, the connector includes a slot disposed at the distal end of the tunnel making rod 20 and an elastic body fixed in the slot, the elastic body has an inner surface (i.e., defines an inner hole), and the inner surface size (inner hole aperture) of the elastic body is smaller than the outer surface size (electrode outer diameter) of the electrode 3. The elastic body is also made of soft materials, such as silica gel or polyurethane, and the electrodes can be fixed by utilizing the deformation capability of the soft materials. The elastic body is preferably bonded with the slot through glue, the process is simple, and the cost is low. Further, the elastic body may include at least one elastic ring to circumferentially clamp the electrode 3, or may include a plurality of circumferentially distributed elastic protrusions, and an inner hole defined by a connection line between the elastic protrusions is smaller than an outer diameter of the electrode 3. It should be understood that there are many ways of clamping the electrode 3 by elastic deformation of the elastic body, and some ways are illustrated herein by way of example only, but should not be taken as limiting the invention in these ways.

The tunneling tool 100 of the present embodiment has two usage modes, one is to use the tunneling tube 30 for subcutaneous tunneling, and the other is to use the tunneling rod 20 for subcutaneous tunneling. The two modes will be described below by taking subcutaneous tunneling of an intracerebral electrode (e.g., a DBS electrode) as an example, but the present invention should not be limited to this application.

Taking the scenario of the electrode 3 being routed from the cranial hole to the back of the ear as an example, the first usage of the tunneling tool 100 of the present embodiment is shown in fig. 6 as diagrams a to f:

first, as shown in fig. 6a, a tunneling tool 100 is used to enter from a cranial incision at the top of the head, tunnel along the scalp 200 of the patient, and exit behind the ear to complete subcutaneous tunneling; next, as shown in fig. 6b, the tunneling terminal 40 is unscrewed; then, as shown in fig. 6c, the tunneling tube 30 is pinched by hand, the tunneling rod 20 is pulled out upwards, and the tunneling tube 30 is left under the skin; next, as shown in fig. 6d, the electrode 3 enters the tunneling tube 30 from the top of the patient's head and exits behind the ear; finally, as shown in fig. 6e, the tunneling tube 30 is pulled downward, i.e. the subcutaneous tunneling of the electrode 3 is completed, and the state shown in fig. 6f is obtained, and the electrode 3 is routed to the back of the ear along the subcutaneous tunnel.

A second usage of the tunneling tool 100 of the present embodiment is shown in fig. 7 as fig. a to e:

first, as shown in fig. 7a, a tunneling tool 100 is used to subcutaneously tunnel from the ear back to the cranial burr hole of the crown of the head of a patient; then, as shown in fig. 7b, the tunneling terminal 40 is unscrewed; then, as shown in fig. 7c, one end of the electrode 3 is inserted into the tube 50 at the distal end of the tunneling rod 20; then, as shown in fig. 7d, the tunneling rod 20 is pulled out downwards, at this time, the tunneling tube 30 is also taken out along with the tunneling rod 20, and one end of the electrode 3 also passes out from behind the ear along with the tunneling rod 20; finally, as shown in fig. 7e, the electrode 3 is pulled out from the distal end of the tunneling rod 20, i.e. the subcutaneous tunneling of the electrode 3 is completed, and the state shown in fig. 7e is obtained, and the electrode 3 is routed to the back of the ear along the subcutaneous tunnel.

Therefore, the tunneling tool 100 of the present embodiment can both complete the subcutaneous tunnel of the electrode along the tunneling tube 30 tunneling electrode, and also complete the subcutaneous tunnel of the electrode by making the way of the tunnel rod 20 traction electrode, so as to make the same set of tunneling tool 100 meet the use habits of different doctors, making the subcutaneous tunnel of the electrode more convenient, the operation is also more flexible, and is special, the way of dragging out the electrode 3 by making the tunnel rod 20 is simpler and faster, the operation time can be significantly shortened, and the operation efficiency is improved. Moreover, the tunneling tool 100 may accomplish subcutaneous implantation of a single-sided electrode as well as a bilateral electrode.

Fig. 4 is a schematic view of the structure of the handle in the preferred embodiment of the present invention. As shown in fig. 4 in conjunction with fig. 2, the handle 10 is preferably an open structure, such as a "straight" structure, a "C" structure or other similar non-closed structure (as opposed to a closed structure, such as an annular ring), so as to provide an open gripping space for people with different hands to grip. Here, it should be appreciated that the opening of the C-shaped structure should be large, e.g. with a central angle of less than or equal to 180 °. Further, the area of the cross section of the handle 10 is larger than that of the cross section of the tunnel making rod 20, so that the area of the handheld part is increased, the handheld part is beneficial to being held by a doctor, and the handheld comfort level is good. In this embodiment, the tunnel making rod 20 is a circular rod, the outer diameter of the tunnel making rod 20 is 3.2mm to 3.4mm, at this time, the cross section of the handle 10 has a width W and a length L, the length L of the handle 10 is preferably 70mm to 90mm, the width W of the handle 10 is preferably 16mm to 20mm, and the thickness h of the handle 10 is preferably 14mm to 16mm, so that the handle 10 in these dimensions can ensure the molding strength of the handle 10 and has a good holding effect. Herein, the thickness of the handle 10 is the dimension along the length direction of the tunneling rod 20, and the length and the width of the handle 10 are the dimensions in the direction perpendicular to the length direction of the tunneling rod 20, and the length direction is perpendicular to the width direction; the cross section of the handle 10 refers to a section of the handle 10 perpendicular to the length direction of the tunneling rod 20. Further, it is preferred that handle 10 has towards one side of making tunnel pole 20 and deviates from make the sunken cambered surface of tunnel pole 20 direction, perhaps, one side that handle 10 made tunnel pole 20 dorsad has towards deviate from make the cambered surface that tunnel pole 20 direction is bloated, the cambered surface is mainly the arc surface to in doctor's better gripping, the travelling comfort of gripping is better. Further, the handle 10 is arc-shaped as a whole, and as shown in fig. 4, the profile of the handle 10 along the length direction is arc-shaped, and the curvature radius R is preferably 140mm to 160 mm. In other embodiments, the outer surface of the handle 10 is formed with a protruding or recessed texture to increase friction with the hand when held.

One side of the handle 10 facing the tunnel making rod 20 can be provided with a proximal end limiting portion 101, the proximal end limiting portion 101 is connected with the proximal end of the tunnel making rod 20, and the outer surface size (i.e. the area of the cross section) of the proximal end limiting portion 101 is larger than the outer surface size (the area of the cross section) of the proximal end of the tunnel making tube 30 and smaller than the outer surface size of the handle 10, so that the proximal end is limited by the proximal end limiting portion 101 to move along the axial direction of the tunnel making tube 30. The proximal end limiting portion 101 and the handle 10 may be formed integrally or separately, preferably integrally. The near-end limiting part 101 and the tunnel making rod 20 can be bonded by glue or connected by injection molding. It should be understood that the connection strength between the tunnel making rod 20 and the handle 10 can be further enhanced by the arrangement of the proximal limiting portion 101. In this embodiment, the proximal limiting portion 101 is a circular cylinder, and the diameter of the circular cylinder is larger than the outer diameter of the tunnel-making tube 30. For example, the tunnel making pipe 30 is a circular pipe, the inner diameter of the tunnel making pipe 30 is 3.5mm to 3.8mm, the thickness is 0.2mm to 0.4mm, and at this time, the diameter of the circular cylinder can be designed to be 6.0mm to 8.0 mm. The height of the circular column (i.e. the dimension along the length direction of the tunneling rod 20) is preferably 4.0mm to 6.0mm, so that the manufacturing cost is reduced while the connection strength between the proximal limiting portion 101 and the tunneling rod 20 is ensured and the movement of the tunneling tube 30 to the proximal end is limited.

In this embodiment, the handle 10 is made of a medical polymer material, including but not limited to nylon, teflon, PEEK, and the like. Further, the handle 10 is an injection molded part. The tunnel-making rod 20 can be made of medical metal material or medical polymer material, and has a certain structural strength to ensure the tunneling effect. In this embodiment, the material of the tunnel making rod 20 may be medical stainless steel or other metal materials. The tunnel making tube 30 should also have a certain supporting strength and a certain softness to avoid the injury to the patient when making the tunnel subcutaneously, preferably, the tunnel making tube 30 is made of medical polymer material, such as PP (polypropylene), teflon, etc. The tunneling terminal 40 can be made of a medical metal material or a medical polymer material, such as stainless steel, PEEK, etc. The outer diameter of the tunnel making rod 20 is slightly smaller than the inner diameter of the tunnel making pipe 30, for example, the outer diameter of the tunnel making rod 20 is 3.2mm to 3.4mm, and the inner diameter of the tunnel making pipe is 3.5mm to 3.8 mm. Further, it has the metal mesh grid to make tunnel pipe 30 can be polymer extrusion pipe or extrude the inside increase of intraduct, and the compound pipe that contains the metal mesh grid has better support performance, can strengthen the intensity of making tunnel pipe 30.

Figure 5 is a schematic view of the structure of the distal end of the tunneling tool in a preferred embodiment of the present invention. As shown in fig. 5, the tunnel-making terminal 40 is preferably connected with the tunnel-making rod 20 in a snap-fit manner, so that the tunnel-making terminal is more convenient to disassemble and assemble compared with a threaded connection, the time for disassembling and assembling the tunnel-making terminal 40 can be obviously shortened, and the operation efficiency is improved. In this embodiment, the tunnel making terminal 40 preferably sets up the slot 401 at the proximal end of the tunnel making terminal 40 under the condition that the distal end of the tunnel making rod 20 is limited to make the tunnel tube 30, and sets up the protrusion 202 matched with the slot 401 at the distal end of the tunnel making rod 20, so that the tunnel making rod 20 and the tunnel making terminal 40 pass through the protrusion 202 and the slot 401 are matched and locked. Further, the near end of making tunnel terminal 40 is formed with the cavity, draw-in groove 401 is seted up on the inner wall of cavity, just be provided with on the distal end surface of making tunnel pole 20 with draw-in groove 401 assorted arch 202, when the distal end of making tunnel pole 20 inserts during the cavity, can make arch 202 and draw-in groove 401 cooperation locking. Further, the number of the protrusions 202 is at least two, the protrusions are symmetrically arranged along the circumferential direction of the tunnel building rod 20, and each protrusion 202 is matched and locked with the corresponding clamping groove 401, so that the limiting effect is better. Optionally, the number of the protrusions 202 is 2 to 4. In other embodiments, a continuous circle of protrusion may be disposed on the outer surface of the distal end of the tunneling rod 20, and correspondingly, a continuous circle of locking groove is disposed on the inner surface of the tunneling terminal 40, where the locking groove is a non-cutting through groove. Taking a plurality of protrusions 202 as an example, the protrusions 202 are preferably circular protrusions, which is convenient to process and can avoid stress concentration. The diameter of the protrusion 202 is preferably 1.0mm to 1.2mm, so that the influence on the strength of the tunneling terminal 40 caused by the large clamping groove 401 formed on the tunneling terminal 40 is avoided. Further, the protrusion 202 is configured not to extend beyond the outer surface of the tunneling terminal 40. It should be understood that, in other embodiments, the snap-fit connection structure between the tunnel-making terminal 40 and the tunnel-making rod 20 may be reversed, that is, the protrusion 202 is disposed on the tunnel-making terminal 40, and the slot 401 is disposed on the tunnel-making rod 20.

Further, in order to strengthen the connection strength between the tunnel making terminal 40 and the tunnel making rod 20, the tunnel making terminal 40 and the tunnel making rod 20 can be magnetically connected and are connected by a buckle, so that the connection firmness is better. The present invention is not limited to the manner of magnetic connection, and for example, a magnetic body may be disposed on the tunneling terminal 40, or a magnetic body may be disposed on the tunneling rod 20, or the tunneling terminal 40 or the tunneling rod 20 itself may be made of a magnetic material. Referring back to fig. 3, the proximal end of the tunneling terminal 40 has an outer surface dimension larger than the distal end of the tunneling tube 30, so that the tunneling tube 30 is prevented from moving to the distal end of the tunneling tool 100 by the tunneling terminal 40 limiting the distal end of the tunneling rod 20 to the tunneling tube 30. Specifically, the proximal end face of the tunneling terminal 40 can abut against the distal end face of the tunneling tube 30 for limiting.

With continued reference to fig. 5, the tunneling terminal 40 has a head portion 41 and a tail portion 42, the cross-sectional area of the head portion 41 tapers from the proximal end to the distal end, the tail portion 42 is snap-fit to the tunneling rod 20, the tail portion 42 is preferably connected to the head portion 41 by an arc transition, and the surface of the head portion 41 is smooth, so that the tunneling terminal 40, and particularly the head portion 41, is free from sharp edges, thereby reducing the damage of the tunneling tool 100 to the surrounding tissue during subcutaneous penetration of the patient. The head 41 of the tunneling terminal 40 may be spherical, hemispherical, ellipsoidal or conical, and the tip of the head 41 is smooth.

It should be understood that the preferred embodiments of the present invention are described above, but not limited to the scope of the disclosure of the above embodiments, for example, the invention is not limited to the axial limitation of the tunneling tube 30 by the handle 10 and the tunneling terminal 40, and an additional limitation structure may be provided, for example, the shape of the handle 10 is not particularly limited, or the structure of the snap connection is not particularly limited. In addition, the tunneling tool 100 of the present invention can be applied to subcutaneous tunneling by microstimulation of the deep brain, subcutaneous tunneling by electrical stimulation of the spine, or subcutaneous tunneling of other types of electrodes. In addition, in the tunneling process, if the tunneling tool 100 needs to be rotated, the tunneling tool 100 needs to be rotated in the opposite direction to prevent the tunneling terminal 40 from falling off. The orientation shown in fig. 5 is taken as an indication, the tunnel making rod 20 is kept still, and the tunnel making terminal 40 is rotated in the counterclockwise direction and locked with the tunnel making rod 20, so that in the tunnel making process, if the tunneling tool 100 needs to be rotated, the entire tunneling tool 100 needs to be rotated in the clockwise direction to prevent the tunnel making terminal 40 from falling off. In this embodiment, an arrow may be provided at the proximal end of the tunneling rod 20 to indicate the rotation direction of the tool, so as to further improve the safety of the operation.

In summary, according to the technical solution provided by the embodiment of the present invention, when the tunneling tool 100 is used, the electrode 3 can be tunneled along the tunneling tube 30, and the electrode 3 can be tunneled subcutaneously by pulling the electrode 3 through the tunneling rod 20, so that the same set of tunneling tool 100 can meet the use habits of different doctors, the subcutaneous tunneling of the electrode is more convenient, the operation is more flexible, and the electrode 3 can be pulled out through the tunneling rod 20, so that the operation time can be significantly shortened, and the operation efficiency can be improved. In addition, make tunnel terminal 40 with make tunnel pole 20 snap-fit connection, more preferably both still magnetism are connected, and this kind of connected mode not only locking is reliable, makes things convenient for the dismouting moreover to make tunnel terminal 40, further shortens operation time, simplifies the operation. In addition, the outer surface size of the near end of the tunnel making terminal 40 is greater than the outer surface size of the far end of the tunnel making pipe 30, and the handle 10 faces one side of the tunnel making rod is provided with a near end limiting part, the near end limiting part is connected with the near end of the tunnel making rod, and the outer surface size of the near end limiting part is greater than the outer surface size of the near end of the tunnel making pipe, so that the tunnel making pipe 30 can be limited by the handle 10 and the tunnel making terminal 40 along the axial movement of the tunnel making tool 100, the structure is simpler, and the manufacturing cost is low. Not only here, the area of the cross section of handle 10 is greater than make the area of the cross section of tunnel pole 20 to make the doctor handheld, and the comfort level of gripping is good, especially handle 10 has towards the one side of making tunnel pole 20 towards opening the structure and making the sunken cambered surface of tunnel pole 20 direction, perhaps handle 10 dorsad make one side of tunnel pole 20 have towards deviating from make the cambered surface that the tunnel pole 20 direction was bloated, this design, not only the hand of convenient difference is gripped, and the comfort level of gripping is better moreover.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the present invention.