Ultrasonic Enhancement of Hemodialysis

超声波强化血液透析

• 批准号: 6404454
• 负责人: Steven Allen Africk
• 金额: $ 9.99万
• 依托单位: PRODYNE CORPORATION
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-15 至 2003-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6404454
• 关键词: blood /plasma substitute; hemodialysis; membrane activity; phosphorus; technology /technique development; ultrasound

The goal of this project is the development of innovative ultrasonic technology and commercial devices to increase efficiency of hemodialysis performed with existing dialysis machines, dialyzers and clinical protocols. This will enable more efficacious or possibly shorter dialysis treatments. Specific aims for Phase I are to fully characterize ultrasonic enhancement of flux in standard hollow fiber dialyzers with emphasis on that of phosphorous, to make a preliminary assessment of the safety of the ultrasound required on human blood, and to formulate a preliminary device design for prototyping in Phase II. Dialyzers will be placed in a testbed containing an ultrasonically insonified water bath. A blood substitute of saline spiked with urea, vitamin B-12 and sodium phosphate will be dialyzed over a range of acoustic frequencies and amplitudes. "Blood out" concentrations will be sampled periodically to measure clearance and total solute removal. Dialyzers will then be tested for reuse. Ultrasound regimes found effective without damaging dialyzers will be incorporated into a preliminary device design. Small blood samples will be exposed to ultrasound in these regimes to explore safety. Phase I data will be relevant to further study of dialysis kinetics of phosphorous and to ultrasonic enhancement of diffusion in general. PROPOSED COMMERCIAL APPLICATIONS: The flux enhancement device to be developed in this project will be compatible with existing dialysis equipment without modification. Its use would entail merely inserting a dialyzer - with the usual lines attached - into the device instead of the usual clamp on the side of the dialysis machine. This approach should simplify regulatory acceptance and make it attractive to hospitals and dialysis units. The device itself will be very simple (similar to an ultrasonic cleaner), relatively inexpensive (with price on the order of $3000 $5000) and easy to operate and maintain. An annual market of 10,000 units worldwide may be possible.

该项目的目标是开发创新的超声波技术和商用设备，以提高现有透析机、透析器和临床方案进行血液透析的效率。这将使更有效或可能更短的透析治疗。第一阶段的具体目标是充分表征标准中空纤维透析器中以磷为重点的超声增强通量的特性，初步评估所需超声对人体血液的安全性，并为第二阶段的原型设计制定初步的设备设计。透析器将被放置在一个装有超声不超声水浴的试验台上。一种含有尿素，维生素B-12和磷酸钠的生理盐水的血液替代品将在一定的声波频率和振幅范围内进行透析。“血出”浓度将定期取样，以测量清除和总溶质去除。然后将对透析器进行重复使用测试。发现有效而不损坏透析器的超声方案将纳入初步设备设计。在这些制度下，小血样将暴露在超声波中以探索安全性。第一阶段的数据将与进一步研究磷的透析动力学和超声增强扩散有关。建议的商业应用：本项目开发的通量增强装置将与现有的透析设备兼容，无需修改。它的使用只需要在设备上插入一个透析器——与通常的线路相连——而不是在透析机侧面插入通常的夹子。这种方法应简化监管接受，并使其对医院和透析单位具有吸引力。该设备本身将非常简单（类似于超声波清洗机），相对便宜（价格在3000美元到5000美元之间），易于操作和维护。每年在世界范围内销售1万台是可能的。