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

SBIR 第一阶段：计算机引导骨科激光手术系统的开发

• 批准号: 1913602
• 负责人: Nathan Monty
• 金额: $ 22.47万
• 依托单位: SPATIAL SURGICAL LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1913602&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; computer; guided

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.

这个SBIR第一阶段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得到满足的需求。外科手工工具，如锯子和钻头，在消融过程中通过剪切力和撕裂力固有地损伤组织，迫使患者进入艰难的康复道路，同时伴随着手术部位感染的风险。在骨科关节置换手术中，手锯和手钻造成的骨和软组织损伤是术后关节疼痛、感染风险和长期内植体松动和翻修手术的重要因素。为了改善这些患者的手术结果，SBIR第一阶段项目旨在开发一种全新的组织消融系统，该系统由由有史以来第一个超高速(UHS)透镜定位系统控制的外科激光组成。这种激光系统使用了一种从未在医疗应用中使用过的波长，通过在每个消融点留下健康的血管组织来减少与传统手工工具相关的组织创伤。目前关节替换市场的规模(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的就业机会和可持续的收入。激光系统的成功实施将使激光消融系统应用于许多精细的外科专科，如脑和新生儿手术。SBIR第一阶段项目的关键创新是一种光学系统，它在手术应用中提供3D监视器上的实时观察，在外科应用中使用新的激光波长消除组织坏死的消融通量图案，以及用于自动控制激光束位置和角度的瞬时软件控制反馈。为了实现这些能力并最大限度地提高精度，全组织整形外科设备需要使用双超高速(UHS)光学系统，其操作时间为微秒级，以控制无坏死消融模式中脉冲的新波长。由于激光在消融过程中不会像手工工具那样与组织直接接触，因此光束很容易受到无意中的手部运动的影响，从而使其偏离所需的路径。UHS光学系统自动检测任何不经意的移动，并实时将激光束稳定在正确的消融模式上。高清图像还显示在三维头顶监视器上，使外科医生能够连续实时监控消融过程。AI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。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。