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

这项小企业创新研究（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亚毫米精度的手术提供实时直接视觉指导工具。定位植入式装置、介入性装置、穿刺活检装置或计划在手术过程中移除的病变是一个关键的挑战。提出的研究提供了一种克服上述挑战的方法，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，直接的肿瘤可视化工具将大大缩短手术时间，提高手术效果。这一创新将带来可观的市场机会。根据市场报告，到2020年，美国乳腺病变定位市场将从2015年的4.459亿美元增长到8.78亿美元，年复合增长率为14.5%。根据我们提供的潜在价值，预计到2020年，我们的潜在市场总额将达到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。本项目旨在开发一种术中工具，以高精度的视觉定位乳腺肿瘤。2015年，有231840例浸润性乳腺癌新发病例，估计有60290例非浸润性乳腺癌新增病例。对于外科医生来说，在乳房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，目前的技术无法提供植入装置的定量定位和该位置的实时视觉反馈。因此，它造成了大的再切除率和延长手术时间的问题。该项目建议通过开发一种带有增强现实系统的声导丝来解决这些未满足的需求，该系统可以提供亚毫米范围内肿瘤位置的实时视觉反馈。这些功能是通过我们的两项创新实现的：1)使用声学雷达和增强现实概念可视化浑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，该技术具有优化手术计划、减少手术延误和降低再切除率的潜力。

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.