Article
A novel miniature robotic guidance device for stereotactic neurosurgical procedures: Preliminary experience of the iSys-1
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Published: | June 2, 2015 |
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Objective: Stereotactic interventions are amongst the most frequent procedures in cranial neurosurgery. To overcome the limitations of frame-based, frame-less arm-based, or free-hand techniques, robotic arms have been introduced with the goal to make these surgeries even more accurate and safe. However, the widespread adoption of intraoperative robotic support is mainly limited by the high costs and large size of the available devices. iSys-1 is a miniature robotic system that could overcome these drawbacks.
The aim of this study is to evaluate the feasibility and accuracy of the iSys-1 robotic guidance device in stereotactic neurosurgical procedures.
Method: In a preclinical phantom trial, the accuracy and procedural duration of a representative stereotactic procedure was compared between robotic and manual alignment in 81 cadaver biopsies, respectively.
In the clinical setting, we conducted an approved study to assess the feasibility, accuracy, setup and application time of the iSys-1 robotic guidance in 31 consecutive cases of tumor biopsy (n=18), intracranial catheter (n=9) and depth electrode placement (n=4 patients, n=15 electrodes).
Results: The preclinical phantom trial revealed a mean target error of 0.6 mm (range 0.1-0.9) for robotic guidance versus 1.2 mm (range 0.1-2.6) for manual positioning (p<0.001). The mean procedural duration was 2.6 minutes (range 1.3-5.5) for robotic guidance versus 3.7 minutes (range 2.0-10.5) for manual positioning (p<0.001). In the clinical trial, application of iSys-1 was feasible in all cases. A trajectory alignement error of ≤ 0.1mm was calculated by the navigation system in all cases. The mean robot setup and application times were 12.4 minutes (range 4.2-26.7) and 5.6 minutes (range 3.1-14), respectively. No adverse effects related to the application of the robotic device were encountered.
Conclusions: Our preliminary results indicate that application of iSys-1 in stereotactic neurosurgical procedures is feasible, safe, provides high accuracy and can reduce operating time. Furthermore, the robotic device was found to seamlessly integrate into the routine operating workflow due to connectivity to the preexisting navigation system, flexible operating table attachment and miniature design.