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

这个SBIR一期项目解决了目前在外科应用中使用传统组织消融工具的未满足需求。手术用手工具，如锯和钻，在消融过程中会通过剪切和撕裂力固有地损伤组织，迫使患者进入艰难的恢复过程，并伴有手术部位感染的风险。在骨科关节置换术中，手锯和手钻造成的骨和软组织损伤是术后关节疼痛、感染风险和长期植入物松动和翻修手术的重要因素。为了改善这些患者的手术效果，SBIR一期项目旨在开发一种完全创新的组织消融系统，该系统由有史以来第一个超高速（UHS）透镜定位系统控制的手术激光组成。该激光系统采用了一种从未在医疗应用中使用过的波长，通过在每个消融部位留下健康的血管组织，减少了与传统手工工具相关的组织创伤。目前关节置换市场的规模（每年150亿美元）使这项技术具有强大的商业前景，有可能创造数千个新工作岗位和可持续的收入。激光系统的成功实施将允许激光消融系统应用于许多精细的外科专业，如脑部和新生儿手术。这个SBIR一期项目的关键创新是一个光学系统，它可以在3D监视器上提供实时术中观察，在外科应用中使用新激光波长的烧蚀影响模式，消除组织坏死，以及用于激光束自动位置和角度控制的即时软件控制反馈。为了实现这些功能并最大限度地提高精度，全组织骨科手术设备需要使用双超高速或UHS光学系统，该系统以微秒级的响应时间运行，以控制无坏死烧蚀模式的新波长脉冲。由于激光在消融过程中不像手动工具那样直接与组织接触，因此激光束很容易受到无意的手部运动的影响，从而使其偏离预期的路径。UHS光学系统自动检测任何无意的运动，并实时将激光束稳定在正确的烧蚀模式上。高清图像也显示在一个三维头顶显示器上，使外科医生能够持续实时监测消融情况。人工智能软件在外科医生消融组织时测量组织消融部位的距离和几何特征，作为防止任何不准确移动的额外保障。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。

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.