CN-121987944-A - Craniotomy electrode fixing device

Abstract

The invention discloses a craniotomy electrode fixing device which comprises a fixing base, an electrode lock and a fixing device body, wherein the fixing base is made of at least part of metal materials and at least part of insulating materials, and is provided with a containing space penetrating along the axial direction. The invention is used for the fixed base prepared by adopting the metal material, improves the operation field and reduces the implantation depth and the operation safety under the condition of ensuring small skull opening.

Inventors

• REN LI
• HAO JINGXIANG
• MA FUYE

Assignees

• 景昱医疗科技（苏州）股份有限公司

Dates

Publication Date

20260508

Application Date

20260210

Claims (20)

1. 1. A craniotomy electrode fixing device, characterized by comprising the following steps: The fixing base is made of at least part of metal materials and at least part of insulating materials, and is provided with an accommodating space penetrating along the axial direction; the electrode lock is arranged in the accommodating space.
2. 2. The craniotomy electrode holder of claim 1 wherein the holder base includes an inner ring and an outer ring, the outer ring surrounding and securing at least a portion of an outer peripheral surface of the inner ring, the inner ring forming a receiving space and being configured to receive the electrode lock, the inner ring being formed of a metallic material and the outer ring being formed of an insulating material.
3. 3. The burr hole electrode fixing device of claim 2, wherein the inner ring of the fixing base comprises an axially extending cylindrical main body portion and an annular support rim extending radially outwardly from one end of the main body portion, the wall thickness d3 of the main body portion being 0.4mm or less.
4. 4. The burr hole electrode fixation device of claim 3, wherein the outer ring is integrally formed or overmolded with the inner ring.
5. 5. The cranial hole electrode fixing device according to claim 4, wherein the annular support rim is circumferentially spaced apart with a plurality of connectors for connection with the outer ring, the connectors being wrapped within the outer ring.
6. 6. The cranial hole electrode fixing device according to claim 2, wherein the maximum outer diameter D1 of the outer ring of the fixing base is equal to or less than 18mm, and the outer diameter D2 of the inner ring is equal to or less than 8mm and equal to or less than 10mm.
7. 7. The craniotomy electrode fixture of claim 1 wherein a minimum angle of the electrode lead with respect to the vertical is 24 ° < α1<36 ° when the electrode lead is inserted into the receiving space.
8. 8. The craniotomy electrode holder of claim 2 wherein the outer ring has a wall thickness that tapers from a central region to an edge region, the central region having a thickest dimension of 1.4mm 1mm 2mm and the edge region having a thinnest dimension of 0.5mm 2mm 1mm.
9. 9. The craniotomy electrode fixing device according to claim 2, wherein the bottom surface of the outer ring attached to the skull is an arc-shaped profile matched with the curvature of the skull, and the curvature radius of the arc-shaped profile is 30 mm-140 mm.
10. 10. The burr hole electrode fixation device of claim 3, wherein the inner ring further comprises at least one cantilever unit extending outwardly from the annular support rim, the cantilever unit being adapted to be manually flexed to accommodate a curvature of a skull surface.
11. 11. The cranial hole electrode fixing device according to claim 10, wherein the cantilever unit comprises a cantilever beam connected to the annular support edge and a fixing portion provided at the end of the cantilever beam, and the fixing portion is provided with a mounting hole for threading a fastener.
12. 12. The burr hole electrode fixing apparatus of claim 11, wherein the mounting hole is a counterbore structure having a cross-sectional shape that is circular, racetrack, rectangular, or oval.
13. 13. The craniotomy electrode fixture of claim 11 wherein the upper and/or lower surface of the outer ring is provided with positioning structure adapted to the shape of the cantilever beam and connector for limiting the cantilever beam and connector prior to or during installation; The positioning structure comprises a positioning groove and a positioning column arranged in the positioning groove, and positioning holes matched with the positioning column are formed in the cantilever beam and the connecting piece.
14. 14. The burr hole electrode fixing apparatus of claim 13, wherein the extension path of the cantilever beam is conformed to the upper surface, lower surface, or radially penetrating into the outer ring.
15. 15. The burr hole electrode fixation device of claim 14, wherein the cantilever beam is in an S-shaped or U-shaped curved configuration.
16. 16. The burr hole electrode fixing apparatus of claim 1, wherein a bottom surface of the electrode lock is disposed bare with respect to the fixing base.
17. 17. The cranial hole electrode fixing device according to claim 3, wherein the main body portion further includes a supporting wall for supporting the electrode lock, the supporting wall having a thickness d2≤0.3 mm.
18. 18. The craniotomy electrode holder of claim 17 wherein the support wall is disposed at a bottom of the holder base, the support wall being configured to abut against and support the bottom of the electrode lock, the support wall being a metal wall made of a metal material.
19. 19. The cranial hole electrode fixing device according to claim 3, wherein the electrode lock is provided with a limiting structure, and the limiting structure is engaged with the fixing base to limit the relative movement of the electrode lock and the fixing base.
20. 20. The craniotomy electrode fixing device of claim 19 wherein the side wall of the main body is provided with at least one limit groove, the limit groove is communicated with the accommodating space, the limit structure is arranged on the side wall of the electrode lock, the maximum outer diameter of the limit structure is larger than the inner diameter of the accommodating space, and the at least one limit structure is clamped in the limit groove.

Description

Craniotomy electrode fixing device Technical Field The invention relates to the technical field of medical appliances, in particular to a craniotomy electrode fixing device. Background An implantable nerve electric stimulation system mainly comprises a pulse generator implanted in a human body, an electrode and an external control device. The pulse generator is connected with the electrode, so that the pulse generated by the pulse generator is transmitted to the electrode, and the pulse signal generated by the pulse generator is transmitted to the brain or a specific nerve part by the electrode for electric stimulation, so that the human body function is recovered to a normal operation state. In the operation implantation process, a doctor firstly determines the target position of the brain of the patient through the three-dimensional positioning device, the doctor opens a craniotomy on the skull of the patient according to the target position, inserts the electrode into the target of the brain through the craniotomy, and tests the implantation target by using a test stimulator, and if the stimulation treatment effect accords with the expected effect, the electrode is fixed on the skull by using the craniotomy electrode fixing device. The craniotomy electrode fixing device is used as a key component in the system and is mainly used for firmly fixing the electrode to the skull to prevent the electrode from being displaced or deviate. Common fixation devices generally consist of a fixation base, electrode locks, and a craniofacial cap. The fixed base is anchored to the skull, and the electrode lock is used for clamping and locking the electrode position. In order to ensure bidirectional reliable locking, a boss structure is usually arranged on the inner hole wall of the fixed base in the prior art, one mode is to arrange an annular bearing boss at the lower part of the inner hole and used as a mechanical stop for downward movement of the electrode lock, and the other mode is to design a buckling boss at the middle part or the upper part of the inner hole and buckled with a corresponding groove on the electrode lock so as to prevent the electrode lock from falling upwards. However, in the prior art, most of the craniotomy electrode fixing devices are made of high polymer materials, so that the overall wall of the craniotomy electrode fixing device is thicker, the effective operative field diameter for operation and observation is reduced, the implantation depth is too deep, and especially, the situation that the skull is thin and the opening is small is caused, so that the mechanical interference of the implantation operation to the dura mater and the safety of the operation are improved. Disclosure of Invention The invention aims to provide a craniotomy electrode fixing device which is used for a fixing base made of a metal material, and improves the surgical field, reduces the implantation depth and ensures the safety of surgery under the condition of ensuring small skull perforation. The invention adopts the following technical scheme: a craniotomy electrode fixture comprising: The fixing base is made of at least part of metal materials and at least part of insulating materials, and is provided with an accommodating space penetrating along the axial direction; the electrode lock is arranged in the accommodating space. Preferably, the fixing base comprises an inner ring and an outer ring, the outer ring is coated and fixed on at least part of the outer peripheral surface of the inner ring, the inner ring forms a containing space and is used for containing the electrode lock, the inner ring is made of metal materials, and the outer ring is made of insulating materials. Preferably, the inner ring of the fixing base comprises an axially extending cylindrical main body portion and an annular supporting edge extending radially outwards from one end of the main body portion, and the wall thickness d3 of the main body portion is less than or equal to 0.4mm. Preferably, the outer ring is integrally formed or overmolded with the inner ring. Preferably, the annular supporting edge is circumferentially and alternately provided with a plurality of connecting pieces for connecting with the outer ring, and the connecting pieces are wrapped in the outer ring. Preferably, the maximum outer diameter D1 of the outer ring of the fixed base is less than or equal to 18mm, and the outer diameter D2 of the inner ring is less than or equal to 8mm and less than or equal to 10mm. Preferably, when the electrode lead is inserted into the receiving space, a minimum included angle of the electrode lead with respect to the vertical direction is 24 ° < α1<36 °. Preferably, the wall thickness of the outer ring is gradually reduced from the central area to the edge area, so that an umbrella-shaped structure is formed, the thickest part of the central area is 1.4mm less than or equal to h1 less than or equal to 2mm, and the thinnest part of t