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，使我们能够有效地清除患者体内多余的液体并管理血容量过多。因此，我们建议开发一种简单、安全的微型便携式装置，该装置可以在连续的基础上从充血性心力衰竭（CHF）患者中缓慢地去除足够的过量液体。在这项为期两年的第一阶段研究中，我们将设计和开发这种新的液体清除工艺，并确定小型化设备的设计要求，其中将包括一个可更换的组件。该可更换组件将在体外试验回路中进行设计和评价。测量炎症介质和凝血因子，沿着持续监测血流速度，并测量回路中几个点的相关压力。鉴于目前还没有这种便携式设备可用于临床使用，该设备将有很大的潜力，以提高生存率和降低成本的充血性心力衰竭患者。除了控制充血性心力衰竭和潜在减少左心室肥大（LVH）（透析患者发病率和死亡率的主要原因）的隐含受益外，预计该器械将显著减少患有液体超负荷和肺水肿的透析患者通常发生的过度重复住院。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治疗的主要成本节省。 公共卫生相关性：本提案旨在开发一种便携式血液滤过装置，该装置可连接至中心静脉导管，以提供缓慢、连续的液体清除，从而维持长期透析患者的液体平衡。该设备将对那些难以控制血压、液体潴留和肺水肿的透析患者具有最大价值。所提出的设计是有吸引力的，利用可更换的过滤单元，其可以容易地附接到具有微型泵的推进单元，用于推进血液通过血液过滤器。这种设计可以在整个透析间期轻松实现缓慢、连续的液体清除（1-3 ml/min），使透析患者避免液体过载。除了控制充血性心力衰竭和潜在减少左心室肥大（LVH）（透析患者发病率和死亡率的主要原因）的隐含受益外，预计该器械将显著减少患有液体超负荷和肺水肿的透析患者通常发生的过度重复住院。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）计划的主要成本节省。该器械还可用于管理未接受透析但经常因肺水肿急诊入院的患者的充血性心力衰竭（CHF）。

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.