Sbir phase II: development of a computer-guided, orthopedic laser surgical system

This National Science Foundation Cooperative Agreement in the amount of $997,189 will fund the development of an all-tissue laser-based orthopedic surgery system by Spatial Surgical LLC from August 1, 2022 to July 31, 2024. The award was made under the NSF Technology, Innovation, and Partnerships program (CFDA 47.084), which seeks to advance science and engineering research leading to breakthrough technologies and solutions to national challenges.

Specifically, Spatial Surgical will develop an integrated laser ablation and imaging system for use in distal extremity joint arthroplasty. The single-handpiece device will utilize pulsed carbon dioxide laser technology to precisely cut bone and drill holes without thermal necrosis, while integrated cameras provide real-time 3D visualization. The aims are to reduce surgical time and improve precision for procedures like wrist, ankle and finger joint replacement. If successful, the laser-guided system could improve outcomes for patients through faster recovery and fewer complications.

Abstract

The broader impact/commercial potential of this small business innovation research (SBIR) phase II project is to improve distal extremity joint arthroplasty. Arthroplasty is a surgical procedure to restore the function of a joint. The proposed technology replaces cold knife, electrocautery, orthopedic saws and drills with a hand-held, all-tissue laser ablation system that fast cuts BONE without necrosis. The effect is to reduce surgical time, create more precise cuts and drill holes, decrease recovery times, and reduce the need for opioid medications after surgery. The integrated visualization system may allow orthopedic surgeons to perform precise surgical planning that is difficult or impossible with current methods. While important in hips or knees, surgical precision is critical in wrists, ankles, and fingers/toes. The proposed device produced in this project may improve surgical success rates and reduce complications and revision surgeries, which will reduce patient suffering and excess healthcare costs. At the same time, the proposed tools may enable safe and successful distal extremity joint arthroplasty to be performed routinely. This small business innovation research (SBIR) phase II project seeks to develop an all-tissue laser-based orthopedic surgery system that integrates cameras for real-time, three-dimensional (3D) vision within a single handpiece. Conventional saws and drills compress and shear bones, causing postoperative joint pain and prolonging recovery times. A laser cuts by ablating tissue at its specific molecular absorption without killing the surrounding tissue (i.e., necrosis). One critical technical innovation in this project is to use a pulsed, high peak power, 9.3 ?M wavelength carbon dioxide (CO2) laser that rapidly ablates hydroxyapatite (BONE) and water (soft tissue). The laser pulse widths are chosen to approach the tissue?S thermal relaxation time, TRT, which eliminates necrosis. Another critical technical innovation is to integrate various cameras (similar to smartphone and confocal microscope cameras) within the 9.3 ?M ablation laser pulse train to provide real-time, high-definition, intraoperative vision. The proposed device may be enhanced to demonstrate sufficiently large BONE ablation patterns, clinically acceptable BONE ablation speeds, and non-tapered laser drilling tapering. The instrument will be housed in a handheld device that mimics existing orthopedic tools and will be run by firmware to perform at speeds necessary for clinical use. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.