Innovative, non-invasive, battery-less, disposable cardiac biosensor for hemodynamic monitoring

7.项目总结/摘要 SBIR第一阶段项目将设计和开发一种创新的、微型的、无电池的、一次性的心脏 生物传感器，以提供简单的心肺功能家庭评估。生物传感器将提供可比的 血流动力学测量与金标准评估的对比。经济动力导致提前出院 复杂和老年心血管疾病患者。老年人出院后， 诊断充血性心力衰竭加重、心肌梗死、冠状动脉旁路移植术 外科手术或其他高风险心脏手术的再住院风险较高，死亡率增加 这是由于出院后护理方面的差距造成的。患者可用的评估解决方案 在家里监测，即血压、体重、心电图，并没有显示出减少， 出院后因任何原因再次入院或死亡。侵入性植入器械，例如 MEMS，已经证明，血液动力学测量允许更有效的管理， 减少住院率和死亡率。因此，老年人需要可靠、稳健、安全（非侵入性）， 和简单的技术，可以提供住院后的血流动力学评估。有必要 通过电话咨询或门诊初级保健访问进行有意义的干预，减少再次入院 and mortality.使用这种SBIRs技术，患者将有可能获得金标准 血液动力学测量，通过集成的，可穿戴的，无电池的，心脏生物传感器。生物传感器的 使用安全的近场通信，可以用智能手机读取数据， 护理提供者可以通过智能手机应用程序轻松访问他们的血流动力学测量结果。早期 血流动力学变化的客观测量将导致早期和及时的门诊干预。这 将改善慢性心血管疾病患者的生活质量，使他们能够保持在 家更长。我们有一个多学科的科学家和实践利益相关者团队，他们将共同努力， 开发和测试适用于不同患者人群的概念模型。整体 该项目的目标是证明新技术可以有意义地满足老年人的需求 解决他们的特殊问题和挑战。这将是第一次有一个生物传感器， 解决了市场对无障碍、无创、准确、绝对和可操作系统的需求， 出院后在家使用。这将有助于密切自我监测和门诊监测我们最 易受伤害的病人，同时保持密切监督的卫生保健小组。这种无电池一次性的 用于提供深入血液动力学的生物传感器技术具有额外的深远的益处。这种装置 目前还不存在，因此开辟了许多商业可能性。

7. PROJECT SUMMARY/ABSTRACT This SBIR Phase I project will design and develop an innovative, miniature, battery-less, disposable cardiac biosensor, to provide easy home assessment of heart and lung function. The biosensor will deliver comparable hemodynamic measurements to the gold standard assessments. Economic impetus has led to early discharge of complex and elderly patients with cardiovascular disease. Older adults discharged from hospitals following diagnoses of congestive heart failure exacerbation, myocardial infarction, coronary artery bypass grafting surgery or other high-risk cardiac procedures are at higher risk for re-hospitalizations and increased mortality resulting from gaps in care following hospital discharge. The assessment solutions available for patient monitoring at home, namely, blood pressure, weight, electrocardiograms, have not demonstrated reduction in readmission for any reason or death of any causes after discharge. Invasive implant devices, such as CardioMEMS, have demonstrated that hemodynamic measurements allow more effective management leading to fewer hospitalizations and lower deaths. Thus, aging adults are in need of reliable, robust, safe (non-invasive), and simple technologies that can provide hemodynamic assessment post hospitalization. There is need for meaningful interventions through a phone consultation or outpatient primary care visits that reduce re-admissions and mortality. Using this SBIRs technology, it will be possible for a patient to have access to gold standard hemodynamic measurements, through an integrated, wearable, battery-less, cardiac biosensor. The biosensor’s data can be read with a smart phone using secure near field communication, enabling patients and their health care providers to have easy access to their hemodynamic measurements via a smartphone application. Early objective measurements of hemodynamic changes will lead to early and prompt outpatient interventions. This will improve the quality of life for individuals with chronic cardiovascular conditions enabling them to remain at home longer. We have a multidisciplinary team of scientists and practice stakeholders who will work together to develop and test the conceptual model that will be applicable across diverse patient populations. The overall goal of this project it to demonstrate that new technology can meaningfully accommodate the needs of older adults and address their unique problems and challenges. For the first time there will be a biosensor that truly addresses the market need of an un-obstructive, non-invasive, accurate, absolute and actionable system for post-discharge use at home. This will facilitate close self-monitoring and outpatient monitoring of our most vulnerable patients, while maintaining close supervision by the health care teams. This battery-less, disposable biosensor technology for providing in-depth hemodynamics has additional far reaching benefits. Such a device does not exist today thus opening up numerous commercial possibilities.