Potassium Level Monitoring System

描述（由申请人提供）：先进医疗电子（AME）和我们的合作伙伴提出了一种用于连续监测钾的微创系统。血钾水平的测量在临床医学中是很重要的。钾异常在心脏和肾脏疾病中很常见，许多用于治疗这些疾病的药物会加重钾异常，导致心律失常和死亡。钾值的测定总是需要血液——要么通过静脉切开术，要么通过其他皮肤穿刺。拟议中的项目包括开发一种微创技术，通过记录身体自身对钾水平的反应，无需采血即可确定钾值，从而增加患者的舒适度和便利性。这项技术可以在医院或家中应用，扩展了远程监控平台，并通过允许药物调整来促进独立性和健康，而无需住院进行频繁的血液检查。远程管理患者的能力，从而及早发现和解决健康问题，而无需进行临床访问和抽血，从而改善了对患者的护理，并提高了付款人和提供者提供护理的经济效率。原型系统将在第一阶段进行开发和评估。

DESCRIPTION (provided by applicant): Advanced Medical Electronics (AME) and our partners propose a minimally-invasive system for continuous monitoring of potassium. Measurement of blood levels of potassium is important in clinical medicine. Abnormalities of potassium, common in heart and kidney disease, can be aggravated by many medications used to treat these disorders leading to arrhythmias and death. Determination of potassium values has always required access to blood - either by phlebotomy or other skin puncture. The proposed project involves developing a minimally invasive technology that permits determining potassium values without obtaining blood, by recording the body's own response to potassium levels, thereby increasing comfort and convenience for the patient. This technology can be applied in the hospital or at home, extending a remote monitoring platform, and promoting independence and wellness by permitting medication adjustments without hospitalization for frequent blood tests. The ability to manage patients remotely and thereby identify and address health issues early and without need for a clinical visit and blood draw improves care for patients and increases the economic efficiency of care delivery for payors and providers. A prototype system will be developed and evaluated in phase 1.