Feasibility study of a double fiber bundle dialyzer

双纤维束透析器的可行性研究

• 批准号: 6934073
• 负责人: GARY J MISHKIN
• 金额: $ 10万
• 依托单位: MIRIMEDICAL, LLC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6934073
• 关键词: biomedical equipment development; blood circulation; clearance rate; clinical biomedical equipment; dialysis; hemodialysis; ultrafiltration

DESCRIPTION (provided by applicant): Efficiency of hemodialysis is currently limited by dialyzer technology. Although new membranes with large surface areas have been developed, the increase in delivered treatment is only marginal. Double dialyzer therapies have been shown to be superior to standard high efficiency/ high flux dialysis treatments; however implementation of double dialyzer therapies has been limited by the complexity of the dialysis treatment setup. It is proposed to develop a double fiber bundle dialyzer in a single casing that optimizes diffusive and convective removal of solutes. In series double dialyzer dialysis will be evaluated in-vitro as both the flux and surface area of dialyzers are altered. Clearance of urea, creatinine and Vit B12 will be measured. Filtration in each dialyzer will be assessed to evaluate filtration fractions. Ultimately, the ideal combination(s) of dialyzer size and flux will be derived. This combination(s) will then be applied to a single casing double fiber bundle prototype. This prototype will be evaluated for clearance and filtration characteristics. The limits of the system will be based on dialysis machine operating parameters (i.e. pressures and flows). This double fiber dialyzer will be applicable to all existing dialysis equipment, therefore easily adapted by the dialysis community. This product will provide a dialysis therapy that clearly surpasses existing dialysis efficiencies, applicable to the more than 300,000 dialysis patients in the US and 1 million patients worldwide. A future partnership with a large dialysis equipment manufacturer is one possible route to market. A company such as Baxter Healthcare both manufactures and distributes hemodialyzers throughout the world. Contract manufacturing the dialyzer and distributing via distribution companies or licensing the technology for others to manufacture and distribute are two alternative routes to be evaluated.

描述(由申请人提供)： 目前血液透析的效率受到透析器技术的限制。尽管已经开发了具有较大表面积的新膜，但递送处理的增加只是微乎其微。双透析器疗法已被证明优于标准的高效率/高通量透析疗法；然而，由于透析治疗设置的复杂性，双透析器疗法的实施一直受到限制。建议开发一种单套管内的双纤维束透析器，以优化溶质的扩散和对流去除。通过改变透析器的通量和表面积，将在体外对双透析器的透析性进行评估。将测量尿素、肌酐和维生素B12的清除量。将评估每个透析器中的过滤，以评估过滤分数。最终，将得出透析器尺寸和通量的理想组合(S)。然后将这种组合(S)应用于单壳双光纤束原型。将对该样机的净空和过滤特性进行评估。系统的极限将基于透析机的操作参数(即压力和流量)。这种双纤维透析器将适用于所有现有的透析设备，因此很容易被透析界采用。该产品将提供一种明显超过现有透析效率的透析疗法，适用于美国30多万名透析患者和全球100万名患者。未来与一家大型透析设备制造商合作是进入市场的一条可能途径。像Baxter Healthcare这样的公司在世界各地制造和分销血液透析器。合同制造透析器并通过分销公司分销，或授权他人制造和分销技术是两种可供选择的评估途径。