Feasibility study of a double fiber bundle dialyzer

描述（由申请人提供）： 血液透析的效率目前受到透析器技术的限制。虽然已经开发出具有大表面积的新膜，但所提供的治疗的增加仅是微不足道的。双透析器治疗已被证明上级标准高效/高通量透析治疗;然而，双透析器治疗的实施受到透析治疗设置复杂性的限制。 建议在单个外壳中开发双纤维束透析器，以优化溶质的扩散和对流清除。 将在体外评价串联双透析器透析，因为透析器的通量和表面积都发生了变化。将测量尿素、肌酐和维生素B12的清除率。将评估每个透析器中的滤过，以评价滤过分数。最终，将得出透析器尺寸和通量的理想组合。然后将该组合应用于单套管双光纤束原型。将评价该原型的清除率和过滤特性。系统限值将基于透析机操作参数（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，因此很容易被透析社区所适应。该产品将提供一种明显超过现有透析效率的透析治疗，适用于美国30多万名透析患者和全球100万名患者。 与大型透析设备制造商的未来合作伙伴关系是进入市场的一条可能途径。像巴克斯特医疗保健公司这样的公司在世界各地生产和销售血液透析器。 合同制造透析器并通过分销公司分销或将技术许可他人制造和分销是两种待评价的替代途径。

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.