Objective: Deep brain stimulation (DBS) leads need to be securely fixed at the burr-hole after implantation. Commercial devices for this purpose have to be placed over the burr-hole before DBS-lead insertion and have a relatively high profile leading to palpable and even visible elevations of the skin with an unfavorable cosmetic result especially in patients suffering from alopecia.

Background: We developed a burr-hole cover, which can be inserted at any time during surgery, even after DBS-lead placement, which is fully inserted into a 14mm trephination and provides a secure lead fixation.

Method: The burr-hole cover named “Invisilock” is built as patient-specific implant from PEEK. Since its introduction in June 2020, 39 patients received this device. After case 9, integrity of the leads was checked before and after fixation to ensure they were not damaged during the fixation process by compression or bending. Furthermore, the patient’s skin shape was documented using a contour gauge, allowing objective measurement of skin surface alterations after DBS.

Results: All 39 surgeries were uneventful and the device worked as intended. The implant was improved twice, after case 9 and after case 29, by reducing the thickness of the “wings” for optional screw fixation and replacing the clip for initial fixation with a fine spring to prevent damaging the lead by compression. After the first series of nine implantations, all surgeries could be performed without intraoperative X-ray for control of lead implantation depth, reducing radiation exposure for the surgical team and improving working comfort. There were no cases of lead dislocation during the fixation process or subsequent lead migration. All patients were satisfied with the cosmetic result and claimed not being able to see or palpate the burr-hole covers. In the cases, where the skin surface was measured using the contour gauge, skin elevation was objectively below 1 mm. Two patients suffered from local would healing disturbance, which could be treated successfully without need to explant lead or burr-hole cover.

Conclusion: We report our development process and first clinical results of a new invisible and secure burr-hole cover and lead fixation for DBS. So far, the device proved superiority over commercial devices regarding the cosmetic result, ease of handling and security of fixation.

« Back to 2022 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/invisible-dbs-lead-fixation-using-a-patient-specific-burr-hole-cover/