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

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是为乳腺癌社区服务。2015年有231，840例新发浸润性乳腺癌病例。手术费用约为6000美元，平均每分钟60美元，再次手术率为25%。由于其竞争优势，AcouStar可以有效地减少手术延迟，并可能最大限度地减少再次切除率。因此，AcouStar可以有效地降低医院的手术费用，保险公司的报销费用，以及患者的身体痛苦和情绪困扰。该公司的创新解决了相当大的市场机会。根据一份市场报告，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%。凭借该公司可能提供的价值，预计到2020年，可寻址市场总额将达到约2亿美元。这一创新将不仅适用于乳腺癌手术导航，它也可以作为一个内部跟踪设备用于多个其他应用，如植入式设备跟踪，内窥镜跟踪，导航部分肾脏切除等。这个小企业创新研究第二阶段项目旨在解决乳房肿瘤切除术中的手术导航问题。保乳治疗，或乳房肿瘤切除术，放射治疗已成为一个更好的选择，乳房切除术，其更好的美容效果和病人的健康护理。然而，这是具有挑战性的外科医生准确定位肿瘤在肿块切除术，特别是当肿瘤是不可触及的。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。Vibronix公司提出通过开发一种具有增强现实系统的声学导丝来解决这些未满足的需求，该系统可以提供关于肿瘤位置的实时视觉反馈，具有亚毫米的变化。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，该设备，命名为AcouStar系统，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。该奖项反映了NSF的法定使命，并已被认为是值得支持的评估使用基金会的智力价值和更广泛的影响审查标准。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to serve the breast cancer community. In 2015 there were 231,840 new cases of invasive breast cancer. The surgical procedure cost ~$6000 with an average $60 per minute cost and 25% re-operation rate. Owing to its competitive advantages, the AcouStar can effectively reduce the surgical delay and potentially minimize the re-excision rate. Therefore, AcouStar can effectively reduce the surgical cost for the hospital, the reimbursement cost for the insurance company, and physical pain and emotional distress for the patients. The company's innovation addresses a considerable market opportunity. According to a 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 the company may potentially provide, the total addressable market is estimated to be ~$200 million in 2020. This innovation will not only be applicable for breast cancer surgery navigation, it may also be used as an internal tracking device for multiple other applications, such as implantable device tracking, endoscope tracking, navigation for partial kidney removal etc.This Small Business Innovation Research Phase II project aims to solve the problems of surgical navigation in lumpectomy. Breast conserving therapy, or lumpectomy, with radiation therapy has become a preferable choice over mastectomy for its better cosmetic outcome and patient health care. However, it is challenging for the surgeon to accurately localize the tumor during lumpectomy, especially when the tumor is non-palpable. Current technologies cannot provide quantitative location of the implanted device and real-time visual feedback of that location. Vibronix, Inc 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 device, named the AcouStar system, has the potential to optimize surgical planning, minimize surgical delays, and reduce the re-excision rate.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.