SBIR Phase I: Development of a connected implantable vascular access port to facilitate oncology drug delivery and AI-data analytics for personalized cancer care

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力包括在降低治疗成本的同时提高癌症护理的存活率和生活质量的潜力。美国每年有170万人被诊断出癌症。到2020年，全国用于癌症护理的支出预计将达到1560亿美元。癌症治疗大多在门诊环境中进行，让患者在家中无人监护，同时面临高风险的并发症，这可能导致紧急服务和相关住院的高利用率。及早发现并发症可以在最有效的时候触发快速干预，从而改善结果并降低成本。连接的可植入血管接入端口将提供癌症药物输送和生理监测的无菌手段。先进的分析将识别出出现常见并发症的最早迹象的患者。最后，聚合数据将为医院更好地了解结果和成本提供有价值的见解，为业界和学术研究人员开发下一代癌症疗法提供有价值的研究工具。这一小企业创新研究(SBIR)第一阶段项目将推动技术开发，朝着能够静脉给药和患者监测的链接植入式血管接入端口(VAP)发展。拟议的研究将侧重于技术开发中的风险和临床重要的终点。为了方便使用，链接的植入式VAP将通过安全的蓝牙无线与患者的移动设备进行通信。目标1专注于建立一个前端移动应用程序来控制‎多传感器输入和关联元数据的收集和传输。这一移动应用程序将在植入的传感器技术和用于分析的云数据库之间提供关键链接。作为一种植入式医疗设备，更换电源将带来不可接受的风险和成本。因此，目标2侧重于电源特性、选择和优化。在AIM#2中，将根据临床需要确定12个月主动患者监测的电源需求，并用于确定与植入相兼容的电源。大多数癌症患者需要放射治疗作为其治疗的一部分。因此，了解电离辐射对植入癌症患者体内的任何设备的影响是至关重要的。目标#3通过对设备进行体外照射来满足这一需求。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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 I project includes the potential to improve survival and quality of life outcomes in cancer care while decreasing treatment costs. Each year, 1.7 million people in the US are diagnosed with cancer. National expenditures on cancer care are projected to reach $156 billion by 2020. Cancer treatment is delivered mostly in an outpatient setting, leaving patients unmonitored at home while at high risk of complications that can lead to high utilization of emergency services and associated hospitalizations. Early detection of complications can trigger rapid intervention when most effective, leading to improved outcomes and lower costs. A linked implantable vascular access port will provide sterile means of cancer drug delivery and physiologic monitoring. Advanced analytics will identify patients showing the earliest signs of common complications. Finally, aggregated data will provide valuable insights for hospitals to better understand outcomes and costs, serving as a valuable research tool for industry and academic researchers developing next-generation cancer therapies.This Small Business Innovation Research (SBIR) Phase I project will advance technology development toward a linked implantable vascular access port (VAP) capable of intravenous drug delivery and patient monitoring. The proposed research will focus on risk in technology development and clinically important endpoints. For ease of use, the linked implantable VAP will communicate with the patient’s mobile device via secure Bluetooth wireless. Aim #1 focuses on establishing a front-end mobile application to control the collection and transport of ‎multiple sensor inputs and associated metadata. This mobile application will provide a critical link between the implanted sensor technology and the cloud database for analytics. As an implantable medical device, replacing the power supply would carry unacceptable risks and costs. Therefore, Aim #2 focuses on power supply characterization, selection, and optimization. In Aim #2 power requirements for 12 months of active patient monitoring will be identified based on clinical needs and used to identify a power supply compatible with implantation. Most cancer patients require radiation therapy as part of their treatment. It is therefore critical to understand the effect of ionizing radiation on any device implanted in cancer patients. Aim #3 addresses this need through in vitro irradiation of the device.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.