A Novel Device for Managing Hypervolemia in CHF Patients

描述（由申请人提供）：我们发现了一种新的方式，可以有效地清除患者体内多余的液体并控制高血容量。因此，我们建议开发一种简单、安全的微型便携式设备，可以持续缓慢地从充血性心力衰竭（CHF）患者体内清除足够的多余液体。在为期两年的第一阶段研究中，我们将设计和开发这种新的流体去除工艺，并定义小型化设备的设计要求，其中将包括一个可更换的组件。该可替换组件将在体外测试电路中进行设计和评估。测量炎症介质和凝血因子，同时持续监测血流速率，并测量回路中几个点的相关压力。鉴于目前还没有可用于临床的便携式设备，该设备将具有提高顽固性充血性心力衰竭患者生存率和降低成本的强大潜力。除了控制充血性心力衰竭和潜在减少左心室肥厚（LVH）的潜在益处（LVH是透析患者发病率和死亡率的主要原因）外，该装置还有望显著减少因液体超载和肺水肿而导致的透析患者的过度重复住院。减少这些紧急住院的数量无疑将是医疗保险资助的终末期肾病（ESRD）和CHF治疗的主要成本节约。

DESCRIPTION (provided by applicant): We discovered a new modality that will allow us to effectively remove excess fluid from patients and manage hypervolemia. Accordingly, we propose the development of a simple, safe miniature portable device that can slowly remove sufficient excess fluid, on a continuous basis, from patients with congestive heart failure (CHF). During this two-year Phase I study, we will design and develop this new fluid removal process, and define the design requirements for the miniaturized device, which will include a replaceable component. This replaceable component will be designed and evaluated in an in vitro testing circuit. Measurement of inflammatory mediators and clotting factors will be made, along with the continuous monitoring of blood flow rate, and associated pressures at several points in the circuit will be made. Given that there are no such portable devices available for clinical use, this device will have strong potential for improving survival and for decreasing costs for patients with recalcitrant congestive heart failure. Aside from the implied benefit of controlling congestive heart failure and potentially reducing left ventricular hypertrophy (LVH), a major cause of morbidity and mortality in dialysis patients, this device would be expected to dramatically reduce the excess, repetitive hospitalizations commonly incurred by dialysis patients who suffer from fluid overload and pulmonary edema. Reducing the number of these emergency hospitalizations would undoubtedly be a major cost savings for the Medicare-funded End Stage Renal Disease (ESRD) and CHF treatments. PUBLIC HEALTH RELEVANCE: This proposal addresses the development of a portable hemofiltration device which can be attached to a central venous catheter for the purpose of providing slow, continuous fluid removal for the maintenance of fluid balance in patients on chronic dialysis. This device would have the most value for those dialysis patients who are having difficulty in controlling blood pressure, fluid retention and pulmonary edema. The proposed design is appealing, with the utilization of a replaceable filtration unit which can be easily attached to a propulsion unit with miniature pumps for propelling blood through a hemofilter. This design could easily allow for slow, continuous fluid removal (1-3 ml/min) throughout the interdialytic period, allowing dialysis patients to avoid fluid overload. Aside from the implied benefit of controlling congestive heart failure and potentially reducing left ventricular hypertrophy (LVH), a major cause of morbidity and mortality in dialysis patients, this device would be expected to dramatically reduce the excess, repetitive hospitalizations commonly incurred by dialysis patients who suffer from fluid overload and pulmonary edema. Reducing the number of these emergency hospitalizations would undoubtedly be a major cost savings for the Medicare-funded End Stage Renal Disease (ESRD) program. This device could also be used for the management of congestive heart failure (CHF) in patients who are not on dialysis but in whom emergency admissions for pulmonary edema are a common occurrence.