Briteseed, LLC

Development of a Multispectral Kerrison Rongeur for Dura and Nerve Root Detection - Project Summary/abstract the Overarching Objective of This Fast-track Small Business Innovation Research (SBIR) Proposal Is to Create the First Kerrison Rongeur (KR) With an Integrated Optical Sensor Capable of Detecting Dura and Nerve Root During Spinal Surgery. Dura and Nerve Roots Are Delicate Structures Critical to Proper Neural Function, Sensation, and Movement and Are Damaged in Up to 17% and 25% of Certain Spinal Procedures Respectively. Incidental Damage to These Structures Can Lead to Major Complications, Longer Surgery Durations, and Additional Operations. Currently, Surgeons Avoid Incidental Dural and Nerve Damage by Attempting to Maintain Sufficient Separation Between the Critical and Unwanted Tissue During Dissection But Have No Means of Directly Visualizing or Identifying These Structures During Critical Points of Dissection. KRS, a Surgical Instrument Used to Gouge Out Bone, Are Often Used at These Critical Points When Dura and Nerve Roots Are at the Highest Risk of Being Injured. to Prevent These Unfortunate Outcomes, the Goal of Phase I of This Proposal Is to Further Establish the Feasibility and Performance of a Miniaturized Optical Sensor for Dura and Nerve Root Detection Capable of Integrating Into a KR. in Order to Physically Incorporate an Optical Sensor Into a KR, a Custom Optical Subsystem Will Be Designed Consisting of an Optical Sensor, a Force Transducer, and Protective Housing for the Optoelectronic Components. Once Assembled, a 3D Printed, Multispectral KR (MKR) Prototype Equipped With the Miniaturized Optical Subsystem Will Be Constructed to Validate Dura and Nerve Root Classification Performance Under Known Pressure Conditions. the Goal of Phase Ii of This Proposal Is to Incorporate the Characterized Optical Subsystem From Phase I Into a Fully Functional MKR Capable of Bone Gouging and in Vivo Detection of Dura and Nerve. to That End, the MKR Prototype Will Be Constructed and Evaluated in Three Areas: Dura and Nerve Root Detection, Bone Gouging Performance, and Shielding of the Optical Subsystem. the Bone Gouging and the Protective Housing of the MKR Will Be Determined Using Biomechanical Bone Phantoms and Fresh Ovine Bone Samples. to Demonstrate in Vivo Functionality, the MKR Will Be Evaluated During Porcine Laminectomy Performed by a Spinal Surgeon. at the Conclusion of This Proposal, Briteseed Will Be Well Positioned to Initiate Product Development and Commercialization of a MKR That Has the Potential to Reduce the Incidence of Iatrogenic Damage to Dura and Nerve Roots.