Rapid Fabrication of Custom Patient Biopsy Guides

Image guided surgery is currently performed using frame-based as well as frameless approaches. In order to reduce the invasive nature of stereotactic guidance as well as to reduce the cost in both equipment and time required within the operating room we investigated the use of rapid prototyping (RP) technology. In our approach we fabricated custom patient specific face-masks and guides that can be applied to the patient during surgery. These guides provide a stereotactic reference for the accurate placement of surgical tools to a pre-planned target along a pre-planned trajectory. While the use of RP machines has previously been shown to be satisfactory for the accuracy standpoint, one of our design criteria, completing the entire built and introduction into the sterile field in less than 120 minutes, was unobtainable. Our primary problems were the fabrication time and the non-resistance of the built material to high-temperature sterilization. In the current study, we have investigated the use of subtractive rapid prototyping (SRP) machines to perform the same quality of surgical guidance while improving the fabrication time and allowing for choosing materials suitable for sterilization. Because SRP technology does not offer the same flexibility as RP in term of prototype shape and complexity, our software program was adapted to provide new guide designs suitable for SRP fabrication. The biopsy guide was subdivided for a more efficient built with the parts being uniquely assembled to form the final guide. The accuracy of the assembly was then assessed using a modified Brown-Roberts-Wells phantom base that allows measuring the position of a biopsy needle introduced into the guide and comparing it with the actual planned target. These tests showed that 1) SRP machines provide an average accuracy of 0.77 mm with a standard deviation of 0.05 mm (plus or minus one image pixel) and 2) SRP allows for fabrication and sterilization within three and a half hours after diagnostic image acquisition and we are confident that that further improvements can reduce this time to less than two hours. Further tests will determine the accuracy of the positioning of the face mask on the patient's head under an IRB-approved trial judged against actual frame-based and frameless systems.