CN114652956A

CN114652956A - Electrode locking device

Info

Publication number: CN114652956A
Application number: CN202210283847.XA
Authority: CN
Inventors: 王晓凯; 唐龙军; 何庆; 徐永强
Original assignee: Shanghai Shenyi Medical Technology Co ltd
Current assignee: Shanghai Shenyi Medical Technology Co ltd
Priority date: 2020-10-21
Filing date: 2020-10-21
Publication date: 2022-06-24
Also published as: CN114377292A; CN114652955A

Abstract

The present invention provides an electrode locking device, comprising: the electrode holder comprises a mounting piece and a fixing piece, wherein the fixing piece is arranged at the proximal end of the mounting piece and surrounds the mounting piece; the electrode clamp has an open state and a closed state, is embedded in the mounting part and clamps the electrode led out from the far end of the mounting part when being switched from the open state to the closed state; the skull cap is coupled to the mount for closing a proximal end of the mount. Because a part of the electrode locking device can be sunk into the skull, the thickness of the whole device does not need to be thinned, and meanwhile, the thickness of the protrusion on the surface can be reduced, so that a series of problems of easy breakage, influence on installation, inconvenience in disassembly, easy displacement of the electrode and the like caused by thinning of the thickness of the device can be avoided.

Description

Electrode locking device

The present case is application number: 202011134386.7, title of the invention: divisional application of Chinese patent of electrode locking device

Technical Field

The invention relates to the technical field of medical instruments, in particular to an electrode locking device.

Background

Parkinson's disease is a common nervous system degenerative disease, and is common in the elderly, with an average onset age of about 60 years. 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 DBS system used is shown in fig. 1 and comprises a pulse generator (usually abbreviated as IPG)1, extension leads 2, electrodes 3, extension leads 4, electrodes 5 (two extension leads and two electrodes are required for bilateral stimulation). One end of the electrode 3 is implanted into the brain by about 10cm, the rest is embedded under the skin of the head, the other end 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.

Before electrode implantation, the patient is firstly evaluated to detect whether the thickness of the skull is more than 5mm, and then an electrode implantation path is planned through CT and MR scanning.

After the pre-operative assessment is completed, the electrode implantation is performed by first cutting the scalp at a predetermined position on the patient's head to expose the skull and making a hole of about 14mm in diameter in the skull. Next, the electrode 3 (shown in fig. 1) is implanted through the cranial burr hole to the target location in the brain (target size is about 5 mm). Then an electrode locking device 4 is arranged on the skull, the electrode 3 is locked by the electrode locking device 4, the electrode 3 is ensured not to move, and the electrode 3 with the redundant length is coiled around the electrode locking device. Finally, the electrode 3 is connected with other components of the DBS system, and after connection, the scalp is sutured, and the operation is completed.

The electrode locking device 4 generally comprises a base fixed to the skull, a screw for locking the base to the skull, a clamping member mounted in the base for clamping the electrode, and a cap which is finally snapped onto the base.

From the above description analysis, it can be seen that the electrode locking device plays a key role in the overall system. Firstly, the functionality is satisfied, the device is convenient for doctors to use in operation, and the electrode is fixed and is ensured not to be displaced. Secondly, the electrode locking device is also as small as possible in size and as thin as possible in thickness, which helps to reduce the scalp tension of the patient and improve the comfort and aesthetic appearance of the patient.

The traditional electrode locking device usually protrudes the skull by about 4mm, and also a certain product protrudes the skull by 1.5mm, which will cause the following disadvantages:

1. when the electrode locking device is made thin, there is a great risk of the strength thereof being broken during the intra-operative operation by the surgeon or after the operation by the patient.

2. After the electrode locking device is thinned, the base in the electrode locking device can be attached to the skull after being bent and deformed, and the thin part has large bending strain, so that the installation of the clamping part can be influenced, and the electrode locking is further influenced.

3. After the electrode locking device is thinned, the size of the buckle is very limited due to the fact that most parts are matched through the buckle, and the stability and the dismounting convenience of the buckled part such as a cover can be affected.

4. With the electrode locking device being thin, the electrode wraps around the base and may shift to the cover and rub against the scalp causing discomfort to the patient.

Disclosure of Invention

It is an object of the present invention to provide a solution to one or more problems of the prior art.

To solve the above technical problem, the present invention provides an electrode locking device, including:

a burr hole mount comprising a mounting member and a fastener disposed at a proximal end of the mounting member and disposed about the mounting member;

an electrode clamp having an open state and a closed state, the electrode clamp being embedded in the mount and clamping an electrode led out from a distal end of the mount when switched from the open state to the closed state; and (c) a second step of,

a skull cap coupled to the mount for closing a proximal end of the mount.

Optionally, in the electrode locking device, the fixing member is a plate-shaped member arranged along an axial direction of the mounting member, and the plate-shaped member is bent toward a distal end of the mounting member, and a curvature radius of the plate-shaped member is 110mm to 130 mm.

Optionally, in the electrode locking apparatus, the thickness of the fixing member in the axial direction of the mounting member is 1.0mm to 3.0 mm.

Optionally, in the electrode locking device, an outer side end of the fixing piece away from the mounting piece is provided with a chamfer.

Optionally, in the electrode locking device, a radius of the chamfer is 0.3mm to 0.8 mm.

Optionally, in the electrode locking device, the fixing member includes two feature setting portions and two redundant portions, two feature setting portions are symmetrically arranged along a first reference line, two redundant portions are symmetrically arranged along a second reference line, and the first reference line is perpendicular to the second reference line.

Optionally, in the electrode locking device, the first reference line length is greater than the second reference line length.

Optionally, in the electrode locking device, gaps are respectively formed between the adjacent feature setting portions and the redundant portions, and the width of each gap is matched with the diameter of the electrode.

Optionally, in the electrode locking device, each feature setting portion is provided with a first clamping groove, a second clamping groove and a tapered hole, the tapered hole is provided at one side of the first clamping groove and the second clamping groove away from the mounting member and is used for a screw to pass through, the skull hole cover has a protruding portion protruding in a radial direction of the mounting member and a first buckle, after the skull hole cover is combined with the mounting member, at least a portion of the first clamping groove is exposed from the protruding portion, and the first buckle is used for buckling the second clamping groove.

Optionally, in the electrode locking device, the electrode clamp includes a holder and a clamping piece, the holder has an opening, one end of the clamping piece is disposed on the holder, and the other end of the clamping piece rotates on the holder, so as to change the width of the exposed portion of the opening to clamp the electrode.

Optionally, in the electrode locking device, the holder has a protrusion, the clamping piece has a receiving cavity, when the clamping piece is located at an initial position, the receiving cavity receives the protrusion, and when the other end of the clamping piece rotates to a stroke end position, the protrusion abuts against one side of the clamping piece, which is far away from the opening, so as to limit a relative position between the clamping piece and the holder.

Optionally, in the electrode locking device, the mounting part has a boss protruding inwards, and a second buckle is arranged on the outer side of the holder and used for buckling the boss along the inner side of the boss so as to limit the relative position of the electrode clamp and the mounting part.

Optionally, the electrode locking device in, the boss be equipped with a plurality of joint portions, it is a plurality of the joint portion is followed the circumference of boss distributes in proper order, the holder has along a plurality of joint holes of circumference evenly distributed, joint portion with the cooperation of joint hole is used, works as joint portion inserts during the joint hole, the restriction the electrode clamp with the relative position of cranium hole seat.

Optionally, in the electrode locking device, the number of the second fasteners is three, and the three second fasteners are uniformly distributed along the circumferential direction of the holder.

Optionally, in the electrode locking device, a plurality of limiting points are arranged at an opening of the clamping seat, the limiting points are sequentially arranged along a length direction of the opening, and the limiting points are used for limiting movement of the electrode in the length direction of the opening after the clamping seat and the clamping piece clamp the electrode.

Optionally, in the electrode locking device, a reinforcing rib structure is arranged on the inner side of the skull cap, and the size of the outer contour of the reinforcing rib structure is matched with the diameter of the skull cap.

Compared with the prior art, the electrode locking device provided by the invention has the following beneficial effects:

(1) according to the electrode locking device provided by the invention, the burr hole seat can be sunk into a part of the skull through the design of the mounting piece and the fixing piece arranged around the mounting piece, so that the thickness of the whole device is not required to be reduced, and meanwhile, the thickness of the protrusion on the surface can be reduced, so that a series of problems caused by the reduction of the thickness of the device can be avoided;

(2) furthermore, according to the electrode locking device provided by the invention, the fixing piece adopts a design that the two characteristic setting parts and the two redundant parts are respectively and symmetrically arranged, and a gap is arranged between the adjacent characteristic setting parts and the redundant parts, so that the fixing piece can be effectively deformed, the fixing piece can be better attached to the skull with different shapes, and the gap between the characteristic setting parts and the redundant parts enables the device to have 4 wire grooves, and a doctor can select a proper position to carry out electrode wire outgoing, so that the applicability of the device is improved;

(3) furthermore, according to the electrode locking device provided by the invention, the curvature radius of the fixing piece is 110 mm-130 mm, and the fixing piece can adapt to the bending curvature of a skull, so that the internal stress of the fixing piece can be reduced, and the stable buckling of the electrode clamp, the buckle structure of the skull hole cover and the skull hole seat can be ensured;

(4) furthermore, in addition to reducing the risk of the device as much as possible, the invention increases the wearing comfort of the patient by arranging the chamfer at the outer side end of the fixing piece, and limits the displacement of the electrode by designing the radius of the chamfer to be 0.3-0.8 mm;

(5) furthermore, the skull hole cover is provided with a reinforcing rib structure, the reinforcing rib structure in the skull hole cover can improve the strength of the skull hole cover under the condition that the skull hole cover is as thin as possible, the bending curvature of the skull hole cover and the skull hole seat is consistent, upward tension is achieved, and the stability of the device is improved.

Drawings

Fig. 1 is a schematic illustration of the installation of a DBS system on the brain;

FIG. 2 is a schematic structural diagram of an electrode locking device according to the present embodiment;

FIG. 3 is a schematic structural view of a burr hole base in the present embodiment;

FIG. 4 is a schematic view of the installation of the burr hole mount of the present embodiment;

FIG. 5 is a schematic view of the electrode clamp of the present embodiment after assembly;

FIG. 6 is a schematic view of the electrode holder of this embodiment before assembly;

FIG. 7 is a schematic structural view of the holder of the present embodiment;

FIG. 8 is a schematic diagram illustrating the closed state of the electrode clamp in the present embodiment;

FIG. 9 is a schematic view of the structure of the skull cap of this embodiment;

FIG. 10 is a schematic view of the reinforcement rib structure of the present embodiment disposed on the skull cap;

FIG. 11 is a schematic view showing the electrode clamping device of the present embodiment;

FIG. 12 is a schematic view of the burr hole cover covering the burr hole seat in this embodiment;

wherein the reference numerals are as follows:

1-a pulse generator; 2-extension wire; 3-an electrode; 4-extension wire; 5-an electrode;

10-cranial foramina base; 11-a mounting member; 12-a fixing member; 20-an electrode clamp; 30-a skull cap; 40-screws; 50-a target object; 121-a feature setting part; 122-redundant portion; 101-taper hole; 102-a first card slot; 103-a second card slot; 104-wire chase; 111-boss; 112-a clamping part; 50-a target object; 60-opening the holes; 21-a holder; 22-a clip; 201-opening; 211-a spacing post; 212-a snap-in hole; 221-a through hole; 213-a second buckle; 214-restriction site; 215-a protrusion; 222-a holding cavity; 216-a profiled hole; 217-square hole; 31-a projection; 32-a first buckle; 33-a rib structure; 70-electrodes.

Detailed Description

The electrode locking device according to the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. 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. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

As used herein, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally employed in a sense including "and/or", the terms "a", "an" and "the" are generally employed in a sense including "at least one", the terms "at least two" are generally employed in a sense including "two or more", the term "proximal" is generally the end that is closest to the operator, the term "distal" is generally the end that is closest to the patient, and further, the terms "first", "second" and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," or "third" may explicitly or implicitly include one or at least two of that feature, with "one end" and "the other end" typically referring to the corresponding two parts, including not only the endpoints. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

As shown in fig. 2, the present invention provides an electrode locking apparatus, comprising: a burr hole seat 10, an electrode clamp 20 and a burr hole cover 30;

the burr hole base 10 comprises a mounting part 11 and a fixing part 12, wherein the fixing part 12 is arranged at the proximal end of the mounting part 11 and is arranged around the mounting part 11;

the electrode clamp 20 has an open state and a closed state, the electrode clamp 20 is embedded in the mounting part 11 and clamps the electrode led out from the distal end of the mounting part 11 when switching from the open state to the closed state;

the burr hole cover 30 is coupled to the fixing member 12 for closing the proximal end of the mounting member 11.

The fixing member 12 is configured to be attached to a target object when the distal end of the mounting member 11 is inserted into the target object, and may be fixed to the target object by a screw 40.

According to the electrode locking device provided by the embodiment, the burr hole seat 10 is designed by adopting the mounting piece 11 and the fixing piece 12 arranged around the mounting piece 11, so that the burr hole seat 10 can be sunk into a part of a skull, the whole thickness of the device does not need to be thinned, meanwhile, the protruding thickness of the surface can be reduced, and a series of problems that the device is easy to break, the mounting is affected, the dismounting is inconvenient, the electrode is easy to shift and the like due to the thinned thickness of the device can be avoided.

The burr hole base 10, the electrode holder 20, and the burr hole cover 30 in this embodiment will be described in detail below.

Referring to fig. 3 in conjunction with fig. 2, preferably, the mounting member 11 is tubular, and the fixing member 12 is a plate-shaped member disposed along an axial direction of the mounting member, that is, a normal direction of the fixing member 12 is the same as the axial direction of the mounting member 11. Because the radius of curvature of the skull of a person is 70-140 mm, and the radius of curvature of the skull of an adult is mostly 110-130 mm, in order to make the burr hole seat 10 fit the skull as much as possible and reduce deformation, in this embodiment, the fixing piece 12 is designed to be bent towards the direction close to the mounting piece 11, that is, the fixing piece 12 is designed to be a spherical bend with 360 degrees in the circumferential direction. Further, the curvature radius of the fixing member 12 is designed to be 110-130 mm, and more preferably 120 mm.

In order to further improve the comfort of the patient during use, the present embodiment provides the following settings for the fixing member 12: the thickness along the axial direction of the mounting piece is designed to be 1.0 mm-3.0 mm, more preferably 1.4mm, and a chamfer is designed at the outer side end of the fixing piece 12 far away from the mounting piece so as to ensure that the edge of the cranial hole seat 10 is excessively smooth; however, when the chamfer of the outer end of the fixing member 12 is too large, the electrode wound around the burr hole base 10 is likely to run on the burr hole cover 30, and thus the chamfer radius is designed to be 0.3mm to 0.8mm, and more preferably, the chamfer characteristic is designed to be 0.6 mm.

For the mounting piece 11, the length of the mounting piece can be designed to be 2.5-4 mm, and is smaller than the skull of a Parkinson patient capable of performing an operation by 5mm, so that influence on brain tissues is avoided.

Referring to fig. 3, in the present embodiment, preferably, the fixing element 12 includes two feature-setting portions 121 and two redundant portions 122, two feature-setting portions are symmetrically disposed along a first reference line, two redundant portions 122 are symmetrically disposed along a second reference line, the first reference line is perpendicular to the second reference line, a gap is formed between each adjacent feature-setting portion 121 and each redundant portion 112, the gap is used as a slot 104 through which an electrode is inserted, the width of the gap is adapted to the diameter of the electrode, and the feature-setting portions 121 and the redundant portions 112 are not connected to each other. This technical scheme can make mounting 12 take place effective deformation, makes mounting 12 laminate the skull of different shapes better, in addition, because adjacent all have the breach between feature setting portion 121 and redundant portion 112, so the quantity of breach is 4 to make the quantity of wire casing 104 also be 4, so, the doctor alright select suitable position to carry out the electrode and be qualified for the next round of competitions, make the suitability of device can improve.

The feature setting part 121 is used for setting some hole features and groove features, and the thickness of the redundant part 122 is the same as that of the feature setting part 121, so as to prevent a gap from being generated between the skull hole cover 30 and the fixing part after the skull hole cover is combined with the fixing part, thereby preventing liquid in the skull hole from flowing out along the side wall of the mounting part after the mounting part 11 is inserted into the skull hole. To facilitate the provision of the hole feature and the slot feature, preferably the length of the first reference line is greater than the length of the second reference line.

Specifically, each of the feature setting parts 121 is provided with a first card slot 102, a second card slot 103, and a tapered hole. The first locking groove 102 is at least partially exposed after the skull cap 30 is covered on the side fixing member 12, and is used for detaching the skull cap 30, and the second locking groove 103 is used in cooperation with the first buckle 32 of the skull cap 30, and is used for buckling the first buckle 32, so as to fix the skull cap 30 on the fixing member 12, and the detailed description of the skull cap 30 is referred to below.

The tapered hole 101 is used for a screw 40 (e.g., a tapping screw 40) to pass through so as to fix the fixing member 12 to a target object. Preferably, the taper hole 40 is disposed on a side of the first locking groove 102 and the second locking groove 103 away from the mounting member 11, so that the edge of the skull cap 30 is not easily tilted after covering the fixing member 12.

Mounting of the burr hole base 10 in cooperation with the screws 40 as shown in fig. 4, the surgeon first opens the hole 60 in the skull bone 50 and then locks the burr hole base 10 to the skull bone 50 by means of two screws 40.

In order to fix the skull cap 30 to the fixing element 12 more firmly, it is further preferable that each feature setting part 121 is provided with two second locking grooves 103, wherein one of the second locking grooves 103, the first locking groove 102 and the other second locking groove 103 are arranged in sequence along the circumferential direction of the fixing element 12, and thus, the skull cap 30 can be pried up smoothly.

For the fixing member 12, the size (including the radial width and the circumferential width) of the redundant portion 112 may be as small as possible, and the feature setting portion 121 may be sized to set the first card slot 102, the second card slot 103 and the taper hole 101, so as to reduce the foreign body sensation to the skull and the scalp and improve the comfort of the patient by compressing the size of the fixing member 12.

In order to facilitate the arrangement of the first engaging groove 102, the second engaging groove 103 and the tapered hole 101, the feature setting portion 121 may be elliptical, and preferably, the feature setting portion 121 may also be valley-shaped, that is, a notch is formed on the basis of the original elliptical feature setting portion 121. In this way, the feature setting part 121 is made as small as possible while ensuring the proper arrangement of the first card slot 102, the second card slot 103, and the tapered hole 101.

In this embodiment, the mounting member 11 has a boss 111 protruding inward, and the boss 111 is provided with a plurality of clamping portions 112. As shown in fig. 3, the clamping portions may be clamping posts or clamping points, each clamping portion 112 faces the proximal end of the mounting member 11 on the boss 111, the boss 111 is used for limiting the displacement of the electrode clamp 20 in the axial direction of the mounting member 11, and the clamping portion 211 is used in cooperation with the clamping hole 212 of the clamp holder 21 for limiting the displacement of the mounting member 11 of the cranial hole seat 10 in the circumferential direction. In a preferred embodiment, the clamping portions 112 are equidistantly distributed on the circumference of the mounting member 11, and when the clamping portions are used with the clamping holes 212 of the electrode holder 20, the angle of the electrode holder relative to the cranial hole base 10 can be adjusted according to the surgical requirements.

Referring to fig. 5 in combination with fig. 8, in the present embodiment, the electrode clamp 20 includes a clamp seat 21 and a clamping piece 22, the clamp seat 21 has an opening 201, one end of the clamping piece 22 is disposed on the clamp seat 21, and the other end of the clamping piece 22 rotates on the clamp seat 21, so as to change the width of the exposed portion of the opening 201 to clamp the electrode. That is, at this time, the electrode holder 20 is switched from the open state to the closed state.

As shown in fig. 6, in order to realize the rotation of the clip 22 on the holder 21, a limiting post 211 may be disposed on the holder 21, one end of the clip 22 has a through hole 221, the through hole 221 is sleeved on the limiting post 211, and the other end of the clip 22 is a free end, so as to rotate on the holder 21.

The outer diameter of the holder 21 is matched to the inner diameter of the mounting member 11, so that the holder 21 does not slide down into a target object when the holder 21 is carried by the boss 111.

As mentioned above, the holder 21 has a plurality of engaging holes 212 for cooperating with the engaging portions 112 of the mounting member 11, and specifically, the number of the engaging holes 212 of the holder 21 is also plural, the plurality of engaging holes 212 are uniformly distributed along the circumferential direction of the holder 21, and when the engaging portions 112 are inserted into the engaging holes 212, the relative positions of the electrode holder 20 and the cranial hole base 10 are limited.

As shown in fig. 7, the outer side of the holder 21 is provided with a second catch 213, and the second catch 213 is used for catching the boss 111 along the inner side of the boss 111 to define the relative position of the electrode clamp 20 and the mounting member 11. The number of the second fasteners 213 may be plural, for example, 2 to 4. Preferably, the number of the second fasteners 213 is three, and the three second fasteners are uniformly distributed along the circumferential direction of the holder 21. Three points define a plane, and the circumferential distribution also makes the fixation of the electrode holder 20 more stable.

Preferably, a plurality of limiting points 214 are disposed at the opening 201 of the holder 21, the limiting points may be convex points or concave grooves, the limiting points 214 are sequentially disposed along the length direction of the opening 201, and the limiting points 214 are used for limiting the movement of the electrode in the length direction of the opening 201 after the electrode is clamped by the holder 21 and the clamping piece 22.

In addition, as shown in fig. 8, the holder 21 has a protrusion, and the clip 22 has a receiving cavity, the receiving cavity receives the protrusion when the clip 22 is located at the initial position, and when the other end of the clip 22 rotates to the end-of-travel position, the protrusion abuts against one side of the clip 22 away from the opening 201 to define the relative position of the clip 22 and the holder 21.

The holding chamber can be through-hole or blind hole, the cross sectional shape of jut can be square, circular or other suitable shapes, and this application is right the shape of jut does not do specific restriction, only need the shape in holding chamber with the shape looks adaptation of jut can.

In addition, in the present embodiment, the holder 21 is designed with a square hole feature and a special-shaped hole feature for mounting and dismounting the electrode holder 20, and the mounting and dismounting tool is not described in the present invention.

As shown in fig. 9, the skull cap 30 has a radially protruding protrusion 31 and a first buckle 32, the protrusion 31 exposes at least a portion of the first locking groove 102, the protrusion 31 is used for cooperating with the first locking groove 102 of the fixing element 12 to complete the detachment, and a detachment tool is not described in this patent. The first buckle 32 is used for buckling with the second clamping groove 103.

Since the device is made thin and the strength of the device needs to be increased as much as possible, in the embodiment, as shown in fig. 10, a reinforcing rib structure 33 is designed on the skull cap 30, the outer contour size of the reinforcing rib structure 33 is matched with the diameter of the skull cap 30 for reinforcing the strength of the skull cap 30, wherein the reinforcing rib structure 33 can be arranged in a cross shape, a meter shape and the like. In addition, it is preferable that the curvature of the burr hole cover 30 is the same as that of the fixing member 12, so that the surface of the burr hole cover 30 is excessively smooth after the burr hole cover is fastened to the burr hole base 10.

The electrode locking device clamping electrode 70 of the scheme is shown in fig. 11, and after the electrode 70 is clamped, a groove on the cranial hole seat 10 is selected to be led out. The scheme designs 4 slots, and can clamp 4 electrodes at most simultaneously. After the electrode clamp 20 is tightened, the skull cap 30 is fastened again as shown in fig. 12, and the whole operation is completed.

The electrode locking device provided by the embodiment can be produced by machining or injection molding, and the burr hole seat 10, the electrode clamp 20 and the burr hole cover 30 can be made of PEEK, PSU, PPSU, polyurethane and other materials. The clamping seat 21 and the clamping piece 22 of the electrode clamp 20 can be directly assembled, or the limiting column 211 is produced by injection molding and assembled with the clamping piece 22 and then assembled with the clamping seat 21 by processes such as ultrasonic welding and the like, so that the combination of the two parts is realized.

It should be noted that the electrode locking device proposed in the present invention is applicable not only to DBS electrode systems but also to electrode fixation required for neurostimulation of the brain such as vagal nerve stimulation electrode systems.

In summary, the electrode locking device provided by the invention comprises a cranial hole seat, an electrode clamp and a cranial hole cover, wherein the cranial hole seat comprises a mounting piece and a fixing piece, and the fixing piece is arranged at the proximal end of the mounting piece and surrounds the mounting piece; the electrode clamp has an open state and a closed state, is embedded in the mounting part and clamps the electrode led out from the far end of the mounting part when being switched from the open state to the closed state; the skull cap is coupled to the fixture for closing the proximal end of the mounting member 11. Because a part of the electrode locking device can be sunk into the skull, the thickness of the whole device does not need to be thinned, and meanwhile, the thickness of the protrusion on the surface can be reduced, so that a series of problems of easy breakage, influence on installation, inconvenience in disassembly, easy displacement of the electrode and the like caused by thinning of the thickness of the device can be avoided.

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 appended claims.

Claims

1. An electrode locking device, comprising:

a burr hole mount comprising a mounting member and a fastener disposed at a proximal end of the mounting member and disposed about the mounting member; the mounting piece is tubular, the thickness of the fixing piece is smaller than the length of the mounting piece in the axial direction of the mounting piece, and the part, which is longer than the fixing piece, of the mounting piece is used for setting in a sinking mode;

an electrode clamp having an open state and a closed state, the electrode clamp being embedded in the mount and clamping an electrode led out from a distal end of the mount when switched from the open state to the closed state; and the number of the first and second groups,

a skull cap coupled to the mount for closing a proximal end of the mount.

2. The electrode locking device of claim 1, wherein the fixing member is a plate-like member disposed along an axial direction of the mounting member, and the plate-like member is bent toward a distal end of the mounting member, and a radius of curvature of the bent plate-like member is 110mm to 130 mm.

3. The electrode locking device of claim 1, wherein the fixture comprises two features and two redundancies, two of the features being symmetrically disposed along a first reference line and two of the redundancies being symmetrically disposed along a second reference line, the first reference line being perpendicular to the second reference line.

4. The electrode locking device of claim 3, wherein adjacent ones of the feature sets and the redundancy have a gap therebetween, the gap having a width that is adapted to a diameter of the electrode.

5. The electrode locking apparatus of claim 3, wherein each feature defines a first engaging groove, a second engaging groove, and a tapered hole defined in a side of the first engaging groove and the second engaging groove remote from the mounting member, the skullcap cover having a radially protruding protrusion and a first snap, the skull cover being coupled to the mounting member such that the protrusion exposes at least a portion of the first engaging groove, and the first snap is adapted to snap into the second engaging groove.

6. The electrode locking device of claim 1, wherein the electrode clamp includes a holder and a jaw, the holder having an opening, one end of the jaw being disposed in the holder, the other end of the jaw being rotated on the holder to change a width of an exposed portion of the opening to hold the electrode.

7. The electrode locking device of claim 6, wherein the holder has a protrusion, and the clip has a receiving cavity, the receiving cavity receiving the protrusion when the clip is in the initial position, and the protrusion abutting against a side of the clip remote from the opening when the other end of the clip is rotated to the end-of-travel position to define a relative position of the clip and the holder.

8. The electrode locking device of claim 6, wherein the mounting member has an inwardly projecting boss, and the outer side of the holder is provided with a second catch for snapping the boss along the inner side of the boss to define the relative position of the electrode holder and the mounting member.

9. The electrode locking device according to claim 8, wherein the boss is provided with a plurality of clamping portions, the plurality of clamping portions are sequentially distributed along the circumferential direction of the boss, the holder is provided with a plurality of clamping holes uniformly distributed along the circumferential direction, the clamping portions are matched with the clamping holes for use, and when the clamping portions are inserted into the clamping holes, the relative positions of the electrode clamp and the cranial hole seat are limited.

10. The electrode locking device according to claim 8, wherein the number of the second catches is three, and the three catches are uniformly distributed along the circumferential direction of the holder.

11. The electrode locking device according to claim 6, wherein a plurality of limiting points are arranged at the opening of the holder, the limiting points are sequentially arranged along the length direction of the opening, and the limiting points are used for limiting the movement of the electrode in the length direction of the opening after the electrode is clamped by the holder and the clamping piece.

12. The electrode locking device of claim 1, wherein the inside of the skull cap is provided with a reinforcing rib structure, and the outer contour dimension of the reinforcing rib structure is matched with the diameter of the skull cap.