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法，可以有效地清除患者体内多余的液体，并管理高容量血症。因此，我们建议开发一种简单、安全的微型便携式设备，可以连续缓慢地清除充血性心力衰竭(CHF)患者的充足多余液体。在这项为期两年的第一阶段研究中，我们将设计和开发这一新的流体去除工艺，并确定微型设备的设计要求，其中将包括一个可更换的部件。这种可更换的部件将在体外测试电路中进行设计和评估。将测量炎症介质和凝血因子，同时持续监测血流速度，并在回路中的多个点进行相关压力测量。鉴于目前还没有这样的便携式设备可供临床使用，这种设备将具有极大的潜力来提高顽固性充血性心力衰竭患者的存活率和降低成本。除了控制充血性心力衰竭和潜在地减少导致透析患者发病率和死亡率的主要原因左心室肥厚(LVH)的潜在好处外，这种设备预计还将大大减少患有液体超载和肺水肿的透析患者通常会导致的过度重复住院。减少这些紧急住院的次数无疑将是联邦医疗保险资助的终末期肾病(ESRD)和CHF治疗的主要成本节省。 与公共卫生相关：这项建议旨在开发一种便携式血液滤过设备，该设备可以连接到中心静脉导管上，目的是提供缓慢、持续的液体清除，以维持慢性透析患者的液体平衡。对于那些难以控制血压、液体滞留和肺水肿的透析患者来说，这种设备将是最有价值的。拟议的设计很吸引人，它使用了一个可更换的过滤单元，它可以很容易地连接到带有微型泵的推进单元上，以推动血液通过血液过滤器。这种设计可以很容易地在整个透析期内缓慢、持续地排出液体(1-3ml/分钟)，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地减少导致透析患者发病率和死亡率的主要原因左心室肥厚(LVH)的潜在好处外，这种设备预计还将大大减少患有液体超载和肺水肿的透析患者通常会导致的过度重复住院。减少这些紧急住院的次数无疑将是联邦医疗保险资助的终末期肾病(ESRD)计划的主要成本节省。该设备还可用于治疗非透析但因肺水肿而紧急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.