SBIR Phase I: Development of a computer-guided orthopedic laser surgical system

This SBIR Phase I project addresses the current unmet need associated with the use of traditional tissue ablation tools in surgical applications. Surgical hand tools, such as saws and drills, inherently injure tissue during ablation through shearing and tearing forces, forcing patients into an arduous recovery path accompanied by risk of surgical site infection. In orthopedic joint replacement surgery, bone and soft tissue injury from hand saws and drills contributes significantly to postoperative joint pain, infection risk, and long-term implant loosening and revision surgery. To improve surgical outcomes for these patients, this SBIR Phase I project aims to develop an entirely innovative tissue ablation system that is comprised of a surgical laser controlled by the first-ever ultra-high speed, or UHS, lens positioning system. The laser system, which employs a wavelength never used in medical applications, reduces the tissue trauma associated with traditional hand tools by leaving healthy, vascularized tissue at each ablation site. The current size of the joint replacement market (>$15 billion annual) positions this technology for a strong commercial future with the potential for thousands of new jobs and sustainable revenues. Successful implementation of the laser system will allow the laser ablation system to be applied across numerous delicate surgical specialties, such as brain and neonatal surgery. The key innovation in this SBIR Phase I project is an optical system that provides real-time intraoperative viewing on a 3D monitor, ablative fluence patterns with a new laser wavelength in surgical applications that eliminates tissue necrosis, and instantaneous software-controlled feedback for automatic positional and angular control of the laser beam. In order to enable these capabilities and maximize precision, the all-tissue orthopedic surgical device requires the use of dual ultra-high speed, or UHS, optical systems that operate with microsecond response times to control the new wavelength pulsed in necrosis-free ablative patterns. Because the laser is not in direct contact with the tissue during ablation, as is the case with hand tools, the beam can be susceptible to inadvertent hand movements that direct it off the desired path. The UHS optical system automatically detects any inadvertent movements and stabilizes the laser beam onto the correct ablation pattern in real-time. The high-definition images are also displayed onto a 3-dimensional overhead monitor to allow the surgeon to continuously monitor the ablation in real time. AI software measures the distance and geometrical features of the tissue ablation site as the surgeon is ablating tissue as an additional safeguard against any inaccurate movements. 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.