SBIR Phase I: Locating a breast tumor with sub-millimeter accuracy to improve the precision of surgery

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是为临床相关环境中以亚毫米精度进行手术的实时直接视觉指导提供工具。这是一个关键的挑战，定位植入的装置，介入装置，针活检装置，或计划在外科手术中移除的病变。拟议的研究提供了一种方法，通过利用可以通过混合增强现实技术直接可视化的内部声源来克服上述挑战。作为乳腺癌手术的一个例子，直接的肿瘤可视化工具将大大缩短手术时间，提高手术结果。这一创新将带来相当大的市场机遇。根据市场报告，到2020年，美国乳房病变本地化市场将从2015年的4.459亿美元达到8.78亿美元，复合年增长率为14.5%。凭借我们潜在提供的价值，我们的潜在市场总额预计在2020年达到约2亿美元，这是一个相当可观且健康的市场。其他市场，包括介入设备或植入设备的可视化，将进一步增加拟议创新的价值。本课题旨在开发一种术中高精度定位乳腺肿块的工具。2015年，浸润性乳腺癌的新增病例为231,840例，非浸润性乳腺癌的新增病例估计为60,290例。对于外科医生来说，在肿块切除术中准确定位肿瘤是具有挑战性的，特别是当肿瘤是不可触及的时候。然而，目前的技术不能提供植入设备的定量定位和该位置的实时视觉反馈。因此，它造成了再切除率高和手术时间延长的问题。该项目建议通过开发一种带有增强现实系统的声学导丝来解决这些未得到满足的需求，该系统可以以亚毫米级的变化提供关于肿瘤位置的实时视觉反馈。这些功能得益于我们的两项创新：1)使用声雷达和增强现实概念在混浊介质中可视化声源位置，用于肿瘤定位；2)超低成本、小型化、全方位声源。由于这些优点，这项技术有可能优化手术计划，最大限度地减少手术延误，降低再次切除率。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to provide a tool for real-time direct visual guidance of surgery with sub-millimeter accuracy in a clinical relevant setting. It is a critical challenge to locate an implanted device, interventional device, needle biopsy device, or lesion that is planned to be removed during a surgical procedure. The proposed study provides a way to overcome the abovementioned challenge by taking advantage of an internal sound source which can be directly visualize via a hybrid augmented reality technology. As an example of breast cancer surgery, a direct tumor visualization tool will greatly reduce the surgical time and improve the surgical outcome. This innovation will bring considerable market opportunity. According to the market report, the U.S. breast lesion localization market will reach $878 million by 2020 from USD 445.9 Million in 2015, with a compound annual growth rate of 14.5%. With the value we potentially provide, our total addressable market is estimated to ~$200 million in 2020, which is a considerable and healthy market. Other market including visualization of an interventional device or implanted device will further increase the value of the proposed innovation. This proposed project is to develop an intraoperative tool to visually locate the breast tumor with high accuracy. In 2015, there were 231,840 new cases of invasive breast cancer, and an estimated 60,290 additional cases of noninvasive breast cancer. It is challenging for the surgeon to accurately localize the tumor during lumpectomy, especially when the tumor is non-palpable. However, the current technologies cannot provide quantitative location of the implanted device and real-time visual feedback of that location. Therefore, it creates problems on a large re-excision rate, and a prolonged surgical time. The project proposes to address these unmet needs by developing an acoustic guide-wire with an augmented reality system that can provide real-time visual feedback on the location of the tumor with sub-millimeter variance. These functions are enabled by two of our innovations: 1) Visualization of the location of an acoustic source in turbid media for tumor localization using acoustic radar and augmented reality concept; 2) An ultra-low cost, miniaturized, omni-directional acoustic source. Owing to these advantages, this technology has the potential to optimize surgical planning, minimize surgical delays and reduce the re-excision rate.