Using Quality Function Deployment to Design an Image-Guided, Multibiopsy Tool for Neurosurgical Applications

Area of Science:

• Neurosurgery
• Biotechnology
• Oncology

Background:

• Molecular characterization of heterogeneous tumors like primary brain tumors requires precise tissue sampling.
• Existing neurosurgical tools are inadequate for modern molecular characterization, limiting analysis to single regions.
• A novel biopsy device is needed for spatially defined, cross-contamination-free tissue collection.

Purpose of the Study:

• To introduce and validate a novel, optically tracked biopsy device for precise, reproducible, and spatially registered tissue collection.
• To improve the molecular characterization of heterogeneous tumors.
• To advance personalized tumor characterization and treatment strategies.

Main Methods:

• Development of prototypes using Quality Function Deployment for user and technical requirements.
• Iterative modeling, 3D printing, proof-of-concept, and phantom testing.
• Comparative testing against Yasargil forceps with neurosurgeons and students; clinical feasibility assessment with intraoperative samples.

Main Results:

• The lead design is an optically tracked capsule attached to Frazier suction, securely containing samples.
• The capsule method reduced variability in sample weight and collection time compared to forceps.
• The device demonstrated ease of use, with students achieving comparable results to experienced surgeons; clinical testing showed no differences in sample variability or tissue preservation.

Conclusions:

• The optically tracked navigated biopsy tool provides a low-cost, efficient, and consistent method for brain biopsy.
• The device is suitable for precision medicine and translational research.
• This novel tool enhances the ability to molecularly characterize spatially heterogeneous tumors.