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

SBIR二期：以亚毫米精度定位乳腺肿瘤，提高手术精度

• 批准号: 1830918
• 负责人: Rui Li
• 金额: $ 70.34万
• 依托单位: Vibronix, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-15 至 2023-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1830918&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Locating; breast

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.

这项小型企业创新研究（SBIR）II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231,840例入侵性乳腺癌病例。手术程序的费用约为6000美元，平均每分钟成本为60美元和25％的重新手术率。由于其竞争优势，奥斯塔尔可以有效地减少手术延迟，并有可能最大程度地减少重新测试率。因此，Acoustar可以有效地降低医院的手术费用，保险公司的报销成本以及患者的身体疼痛和情绪困扰。该公司的创新解决了大量市场机会。根据市场报告，到2020年，美国的乳房病变定位市场将从2015年的4.459亿美元到2020年达到8.78亿美元，复合年增长率为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.乳房保存治疗或乳房切除术，进行放射疗法已成为更好的整容结果和患者医疗保健的乳房切除术的选择。但是，外科医生在肿块切除术期间准确定位肿瘤是一项挑战，尤其是当肿瘤不可钙化时。当前技术无法提供植入设备的定量位置和该位置的实时视觉反馈。 Vibronix，INC提议通过开发具有增强现实系统的声学导向线来满足这些未满足的需求，该系统可以为具有亚毫米差异的肿瘤位置提供实时视觉反馈。这些功能由我们的两项创新启用：1）使用声学雷达和增强现实概念的浊度介质中的声源的位置可视化肿瘤定位； 2）超低成本，微型化的全向声音来源。由于这些优势，该设备被称为AcoustAr系统，有可能优化手术计划，最大程度地减少手术延迟并降低重新判断率。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子和更广泛影响的评估来通过评估来获得支持的，这是值得的。