The Phase I study clearly demonstrated the major advantages of the Novaflux process in reprocessing hemodialyzers with significant improvement in performance and reuse numbers. The two main goals are developing a process that achieves performance equivalent to a new dialyzer with each reuse and maintaining such performance over 30 to 40 reuses. The study focuses on optimizing the chemistry and process parameters needed to effectively clean the fiber lumen and membrane pore structure without adverse effects.
The specific aims are: 1). Studying, developing and selecting cleaning formulations and process parameters to achieve the above goals for two dialyzer types using in-vitro studies; 2). Designing, constructing and validating a dialyzer-reprocessing device to deliver the optimized process parameters; and 3). Performing clinical studies to validate the technology for the F80 and CA210 dialyzers. In-vitro studies are designed to screen several formulations and explore the mode of delivering two-phase fluid dynamics to the dialyzer. Chemical variables include: pH, oxidizing agents and anticlotting compositions. Fluid dynamics parameters are: pressure, temperature, liquid-to-gas ratio and the mode of delivering two-phase flow to the dialyzer. The proposed technology should deliver better dialyzer performance, and improve the overall dialyzer reuse
1. Development of a reprocessing technology that can double the useful life of hemodialyzer cartridges and reduce health care costs. 2. Deliver better dialysis than existing technology in terms of albumin loss and maintenance of small and large molecule clearances. 3. Extrapolation of the technology to other medical applications.
| Dukhin, Stanislav S; Tabani, Yacoob; Lai, Richard et al. (2014) Outside-In Hemofiltration for Prolonged Operation without Clogging. J Memb Sci 464:173-178 |
