A Novel Device for Managing Hypervolemia in CHF Patients

一种治疗慢性心力衰竭患者高血容量的新型装置

基本信息

批准号：
8002223
负责人：
MOHAMED E LABIB
金额：
$ 30万
依托单位：
NOVAFLUX TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-08-18 至 2012-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8002223
关键词：
Address Admission activity Algorithms American Artificial Membranes Blood Blood Circulation Blood Coagulation Factor Blood flow Cardiovascular Diseases Cardiovascular system Catheters Cessation of life Chronic Chronic Kidney Failure Clinical Coagulation Process Collection Complement Activation Congestive Heart Failure Corrosion Cost Savings Data Data Set Development Device Designs Devices Dialysis patients Dialysis procedure Documentation Drops Early Diagnosis Emergency Situation End stage renal failure Evaluation Excision Filtration Fluid Balance Fluid overload Foundations Funding Glomerular Filtration Rate Goals Health Personnel Hemodialysis Hemofiltration Home environment Hospitalization Hospitals Hour Housing Hypertension Individual Inflammation Mediators Inflammatory Kidney Kidney Diseases Kidney Failure Kidney Transplantation Laboratories Left Ventricular Hypertrophy Leg Life Liquid substance Maintenance Measurement Medical Device Medicare Membrane Minority Modality Monitor Morbidity - disease rate National Health and Nutrition Examination Survey Patients Phase Physicians Population Power Sources Process Publications Pulmonary Edema Pump Reaction Renal Replacement Therapy Reporting Risk Safety Simulate Staging System Testing Time To specify Ultrafiltration Venous base blood pressure regulation cost cytokine data acquisition design improved in vitro testing innovation meetings miniaturize mortality novel operation phase 1 study phase 2 study pressure programs prototype public health relevance user-friendly

项目摘要

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.

描述（由申请人提供）：我们发现了一种新的方式，可以让我们有效地去除患者体内多余的液体并控制血容量过多。因此，我们建议开发一种简单、安全的微型便携式设备，可以连续、缓慢地从充血性心力衰竭 (CHF) 患者体内去除足够的多余液体。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，其中包括可更换的组件。该可更换组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，同时连续监测血流速度以及回路中多个点的相关压力。鉴于尚无此类便携式设备可供临床使用，该设备将具有提高顽固性充血性心力衰竭患者的生存率和降低费用的巨大潜力。除了控制充血性心力衰竭和潜在减少左心室肥厚（透析患者发病和死亡的主要原因）的隐含益处外，该设备预计将大大减少透析患者通常发生的过度、重复住院情况。患有体液过多和肺水肿。减少这些紧急住院的次数无疑会为医疗保险资助的终末期肾病 (ESRD) 和 CHF 治疗节省大量成本。公共健康相关性：该提案致力于开发一种便携式血液过滤装置，该装置可以连接到中心静脉导管上，以缓慢、连续地去除液体，以维持慢性透析患者的液体平衡。该装置对于那些难以控制血压、体液潴留和肺水肿的透析患者来说最有价值。所提出的设计很有吸引力，它利用了可更换的过滤单元，该过滤单元可以很容易地连接到带有微型泵的推进单元上，用于推动血液通过血液过滤器。这种设计可以轻松地在整个透析期间缓慢、连续地排出液体（1-3 毫升/分钟），从而使透析患者避免液体超负荷。除了控制充血性心力衰竭和潜在减少左心室肥厚（透析患者发病和死亡的主要原因）的隐含益处外，该设备预计将大大减少透析患者通常发生的过度、重复住院情况。患有体液过多和肺水肿。减少这些紧急住院的次数无疑会为医疗保险资助的终末期肾病 (ESRD) 计划节省大量成本。该设备还可用于治疗未进行透析但经常因肺水肿紧急入院的患者的充血性心力衰竭 (CHF)。