OnPoint Spine, Inc. — Department of Health and Human Services SBIR Phase I: NIBIB

Description

ABSTRACT 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 mm possibly better than mm 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 OHMDandapos s in this proposal include among others Geometric patterns for optical markers optimized for real time optical detection and recognition using images from the OHMDandapos 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 OHMDandapos 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 OHMDandapos 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 PROJECT NARRATIVE Spinal fusion is one of the most frequently performed surgeries in the United States with more than procedures annually with an overall complication rate of and a complication rate per pedicle screw of 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