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

该小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是提供一种在临床相关环境中以亚毫米精度进行实时直接视觉引导手术的工具。定位植入器械、介入器械、穿刺活检器械或计划在外科手术期间切除的病变是一项关键挑战。所提出的研究提供了一种克服上述挑战的方法，通过利用内部声源，可以通过混合增强现实技术直接可视化。以乳腺癌手术为例，直接肿瘤可视化工具将大大缩短手术时间，提高手术效果。这一创新将带来巨大的市场机遇。根据市场报告，到2020年，美国乳腺病变定位市场将从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，我们的总目标市场估计在2020年约为2亿美元，这是一个可观且健康的市场。 其他市场，包括介入器械或植入器械的可视化，将进一步增加拟议创新的价值。本项目旨在开发一种术中工具，以高精度直观定位乳腺肿瘤。2015年，有231，840例新发浸润性乳腺癌病例，估计还有60，290例非浸润性乳腺癌病例。对于外科医生来说，在肿瘤切除术中准确定位肿瘤是一个挑战，特别是当肿瘤不可触及时。然而，目前的技术不能提供植入装置的定量位置和该位置的实时视觉反馈。因此，它产生了大的再切除率和延长的手术时间的问题。 该项目提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满足的需求，该系统可以提供有关肿瘤位置的实时视觉反馈，变化范围为亚毫米。这些功能是通过我们的两项创新实现的：1）使用声雷达和增强现实概念可视化混浊介质中声源的位置，用于肿瘤定位; 2）超低成本，小型化，全向声源。由于这些优点，该技术有可能优化手术计划，最大限度地减少手术延迟并降低再次切除率。

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.