The technology that will be developed in this NIH SBIR Phase I and, later, Phase II proposal will provide novel systems for optical guidance of spinal surgery that will not use any of the expensive components currently used for surgical navigation, intra-operative CT or O-arm imaging or robotics. Instead, the technology will leverage innovative, new hardware such as optical head mounted displays (OHMD) with a low hardware cost, which have become recently available for gaming and industrial applications, against novel techniques of optically registering a patient and a surgical site using optical markers with defined shapes, dimensions and geometries. The system will not require the development or use of expensive imaging equipment in the operating room, but rather utilize existing fluoroscopic equipment available in every operating room in the U.S. By avoiding any of the expensive components of standard surgical navigation, O-arm imaging or intra-operative CT scanning, and robotics, the proposed technology can be made available at a fraction of the price of current systems for guiding spinal fusion for surgical planning. The preliminary data indicate that an accuracy of better than 2mm, possibly better than 1mm, can be achieved which is comparable to the clinical accuracy of current navigation and image guidance system. Novel techniques for further increasing the accuracy of optical registration using OHMD's in this proposal include among others: - Geometric patterns for optical markers optimized for real-time optical detection and recognition using images from the OHMD's video camera. - Use of a priori knowledge of marker size and geometry to determine distance from the OHMD and orientation relative to the OHMD. - Shapes optimized for real-time detection using sensor information from the OHMD's depth camera. - Software to register surgical instruments utilizing optical markers. Optical guidance with existing OHMD hardware and novel software and technology developed in this proposal paired with existing radiographic equipment in the operating room holds the promise to provide accurate intra-operative guidance in a highly cost-efficient manner at fraction of the price of existing navigation, intra-operative CT or O-arm imaging and robotic approaches. Unlike existing techniques, optical guidance using OHMD's and augmented reality display provide a unique advantage of greatly improved hand-eye coordination by accurately registering and superimposing both fluoroscopic image data and the intended path for the surgical instruments onto the surgical field and the corresponding anatomic landmarks, thereby offering a significant benefit over all current techniques. This unique approach has the potential to reduce deviation from the intended path and the possibility of even greater placement accuracy of pedicle screws resulting in less complications.
Spinal fusion is one of the most frequently performed surgeries in the United States with more than 400,000 procedures annually with an overall complication rate of 13% and a complication rate per pedicle screw of 2.4%. Current techniques to address some of these complications such as navigation with intra-operative CT scanning or O-arm imaging and robotics are hampered by high cost that limit their availability. Optical guidance using augmented reality display addresses this concern head on by leveraging recently available optical head mounted displays with low capital equipment cost against existing fluoroscopic equipment in the operating room and provides the unique advantage of greatly improved hand-eye coordination by accurately registering and superimposing both intra-operative fluoroscopic image data and the intended path for the surgical instruments onto the surgical field and the corresponding anatomic landmarks, thereby offering a unique advantage over all current techniques.
