SPATIAL SURGICAL LLC — National Science Foundation SBIR Phase II: BM

SPATIAL SURGICAL LLC — SBIR Phase II award from National Science Foundation.

Amount
$997,189
Agency
National Science Foundation
Program / Phase
SBIR · Phase II
Topic
BM
Solicitation
NSF 21-565
NAICS
Place of performance
MA
Period
2022-08-01 → 2024-07-31

Description

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, 9.3m 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 9.3m 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.