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）二期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231840例浸润性乳腺癌新发病例。手术费用约为6000美元，平均每分钟60美元，再手术率为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切除率。因此，AcouStar可以有效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精神困扰。该公司的创新带来了相当大的市场机会。根据市场报告，美国乳腺病变定位市场将从2015年的4.459亿美元增长到2020年的8.78亿美元，年复合增长率为14.5%。考虑到该公司可能提供的潜在价值，预计到2020年，潜在市场总额将达到2亿美元左右。这项创新不仅适用于乳腺癌手术导航，还可以作为内部跟踪设备用于多种其他应用，如植入式设备跟踪，内窥镜跟踪，部分肾脏切除导航等。本小企业创新研究二期项目旨在解决乳房肿瘤切除术手术导航问题。乳房保留疗法，或乳房肿瘤切除术，放射治疗已成为比乳房切除术更好的选择，因为它具有更好的美容效果和患者的健康护理。然而，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。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。为了解决这些未满足的需求，Vibronix公司开发了一种带有增强现实系统的声导丝，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，这种被命名为AcouStar系统的设备有可能优化手术计划，最大限度地减少手术延误，并降低再切除率。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.