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

SBIR 第二阶段：开发计算机引导的骨科激光手术系统

• 批准号: 2154373
• 负责人: Nathan Monty
• 金额: $ 99.72万
• 依托单位: SPATIAL SURGICAL LLC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2154373&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Development; computer

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 μm 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 μm 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.

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是改善远端肢体关节成形术。关节成形术是一种恢复关节功能的外科手术。这项提议的技术取代了冷刀、电灼、骨科锯和钻头，取而代之的是一种手持式的全组织激光消融系统，可以快速切割骨骼而不会坏死。其效果是减少手术时间，创造更精确的切口和钻孔，减少恢复时间，并减少手术后对阿片类药物的需求。集成的可视化系统可以让骨科医生进行精确的手术计划，这在目前的方法中是困难的或不可能的。手术的精确度对髋部和膝盖很重要，对手腕、脚踝和手指/脚趾也很重要。本项目提出的设备可以提高手术成功率，减少并发症和翻修手术，从而减少患者的痛苦和额外的医疗费用。同时，所提出的工具可以使远端关节成形术安全成功。这个小型企业创新研究（SBIR）二期项目旨在开发一种基于全组织激光的骨科手术系统，该系统将实时、三维（3D）视觉的摄像头集成在一个手机中。传统的锯和钻压缩和剪切骨头，造成术后关节疼痛和延长恢复时间。激光切割通过在组织的特定分子吸收处烧蚀组织而不杀死周围组织（即坏死）。该项目的一项关键技术创新是使用脉冲，峰值功率，9.3 μm波长的二氧化碳（CO2）激光，快速烧蚀羟基磷灰石（骨）和水（软组织）。激光脉冲宽度选择接近组织的热松弛时间，TRT，消除坏死。另一项关键技术创新是在9.3 μm烧蚀激光脉冲序列中集成各种摄像头（类似于智能手机和共聚焦显微镜摄像头），以提供实时、高清的术中视觉。提出的设备可以增强以显示足够大的骨消融模式，临床可接受的骨消融速度和非锥形激光钻孔锥形。该仪器将被安置在一个模仿现有骨科工具的手持设备中，并将由固件运行，以达到临床使用所需的速度。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。