Safety of a Novel Dialyzer Containing a Fluorinated Polyurethane Surface-Modifying Macromolecule in Patients with End-Stage Kidney Disease

<b><i>Background:</i></b> By inhibiting the adsorption of protein and platelets, surface-modifying macromolecules (SMMs) may improve the hemocompatibility of hemodialyzers. This trial aims to assess the performance and safety of a novel dialyzer with a fluorinated polyurethane SMM, Endexo™. <b><i>Methods:</i></b> This prospective, sequential, multicenter, open-label study (NCT03536663) was designed to meet regulatory requirements for clinical testing of new hemodialyzers, including assessment of the in vivo ultrafiltration coefficient (Kuf). Adults prescribed thrice-weekly hemodialysis were eligible for enrollment. After completing 12 hemodialysis sessions with an Optiflux® F160NR dialyzer, patients received 38 sessions with the dialyzer with Endexo. Evaluated parameters included the in vivo Kuf of the dialyzer with Endexo extent of removal of urea, albumin, and β2-microglobulin (β2M), as well as complement activation. <b><i>Results:</i></b> Twenty-three patients received 268 hemodialysis treatments during the Optiflux period, and 18 patients received 664 hemodialysis treatments during the Endexo period. Three serious adverse events were reported, and none of them were considered device related. No overt complement activation was observed with either dialyzer. Both dialyzers were associated with comparable mean increases in serum albumin levels from pre- to posthemodialysis (Optiflux: 7.9%; Endexo: 8.0%). These increases can be viewed in the context of a mean increase in hemoglobin of approximately 5% and a mean ultrafiltration volume removed of approximately 2.2 L. The corrected mean β2M removal rate was 47% higher during the Endexo period (67.73%). Mean treatment times (208 vs. 205 min), blood flow rates (447.7 vs. 447.5 mL/min), dialysate flow rates (698.5 vs. 698.0 mL/min), urea reduction ratio (82 vs. 81%), and spKt/V (2.1 vs. 1.9) were comparable for the Endexo and Optiflux periods, respectively. The mean (SD) Kuf was 15.85 (10.33) mL/h/mm Hg during the first use of the dialyzer with Endexo (primary endpoint) and 16.36 (9.92) mL/h/mm Hg across the Endexo period. <b><i>Conclusions:</i></b> The safety of the novel dialyzer with Endexo was generally comparable to the Optiflux dialyzer, while exhibiting a higher β2M removal rate.

Short-Branched Fluorinated Polyurethane Coating Exhibiting Good Comprehensive Performance and Potential UV Degradation in Leather Waterproofing Modification

In the current leather market, waterproof leather occupies a large proportion, where waterproofness has become one of the important standards for leather selection. However, the most advanced fluorine-containing waterproofing agents on the market always have long chains of over eight carbons (C8), whose use has been restricted due to their bioaccumulation and recalcitrance in natural environment. Consequently, creating waterproof materials characterized by their environmentally friendly qualities and high performance is of great significance. Herein, we report a novel strategy for preparation of the fluorinated polyurethanes containing short branched fluorocarbon chains, and apply it in leather waterproofing. Because the fluorine-containing chain segments are enriched on the coating surface, the waterproof agent coating shows good hydrophobicity, low water absorption, high wear resistance and potential photodegradation of performances. Additionally, the water and oil proof performances of the coating are comparable to that of the marketed C8 waterproofing agent. Its solvent-resistant and antifouling performances are also outstanding. Therefore, the coating can meet the property requirements for daily use and has broad application prospects.

Performance of a novel dialyzer containing a fluorinated polyurethane surface-modifying macromolecule in patients with end-stage kidney disease

Background By inhibiting the adsorption of protein and platelets, surface-modifying macromolecules (SMMs) may improve the hemocompatibility of hemodialyzers. This trial aims to assess the performance and safety of a novel dialyzer with a fluorinated polyurethane SMM, Endexo™, blended into the membrane during manufacturing. Methods This prospective, sequential, multicenter, open-label study enrolled adults prescribed thrice-weekly hemodialysis. After completing 12 hemodialysis sessions with an Optiflux ® F160NR dialyzer , patients received 38 sessions with the dialyzer with Endexo. Evaluated parameters included the extent of removal of urea, albumin, and β2-microglobulin (β2M), as well as complement activation.Results Twenty-three patients received 268 hemodialysis treatments during the Optiflux period, and 18 patients continued on to receive 664 hemodialysis treatments during the Endexo period. Mean treatment times (208 vs 205 min), blood flow rates (447.7 vs 447.5 mL/min), dialysate flow rates (698.5 vs 698.0 mL/min), urea reduction ratio (82% vs 81%) and spKt/V (2.1 vs 1.9) were comparable for the Endexo and Optiflux periods, respectively. No overt complement activation was observed. Both dialyzers were associated with comparable mean increases in serum albumin levels from pre- to post- hemodialysis (Optiflux: 7.9%; Endexo: 8.0%). The corrected mean β2M removal rate was 47% higher during the Endexo period (67.73%). Three serious adverse events were reported, none of them device-related. Conclusions The performance of the novel dialyzer with Endexo was generally comparable to the Optiflux dialyzer, while exhibiting a higher β2M removal rate. Additional studies are needed to determine whether this novel dialyzer can be incorporated into heparin-free hemodialysis approaches.

Hot-melt Adhesive Bonding of Polyurethane/Fluorinated Polyurethane/Alkylsilane-Functionalized Graphene Nanofibrous Fabrics with Enhanced Waterproofness, Breathability, and Mechanical Properties

Waterproof-breathable (WB) materials with outstanding waterproofness, breathability, and mechanical performance are critical in diverse consumer applications. Electrospun nanofibrous membranes with thin fiber diameters, small pore sizes, and high porosity have attracted significant attention in the WB fabric field. Hot-press treatment technology can induce the formation of inter-fiber fusion structures and hence improve the waterproofness and mechanical performance. By combining electrospinning and hot-press treatment technology, polyurethane/fluorinated polyurethane/thermoplastic polyurethane/alkylsilane-functionalized graphene (PU/FPU/TPU/FG) nanofiber WB fabric was fabricated. Subsequently, the morphologies, porous structure, hydrostatic pressure, water vapor transmission rate (WVTR), and stress–strain behavior of the nanofiber WB fabric were systematically investigated. The introduction of the hydrophobic FG sheet structure and the formation of the inter-fiber fusion structure greatly improved not only the waterproofness but also the mechanical performance of the nanofiber WB fabric. The optimized PU/FPU/TPU-50/FG-1.5 WB fabric exhibited an excellent comprehensive performance: a high hydrostatic pressure of 80.4 kPa, a modest WVTR of 7.6 kg m−2 d−1, and a robust tensile stress of 127.59 MPa, which could be used to achieve various applications. This work not only highlights the preparation of materials, but also provides a high-performance nanofiber WB fabric with huge potential application prospects in various fields.

Effect of Nano Alumina on the Properties of Fluorinated Polyurethane

This article selects studies on the preparation of fluorinated polyurethane-nano-alumina composite coating materials, and analyzes the anti-wear, water resistantance, and surface microstructure. Attenuated total reflection-Fourier transform infrared spectroscopy (ATR-FTIR) shows that the polyurethane synthesized in this study does not contain hydrophilic –CH2OH groups. The cavitation wear test depicts that the actual cavitation amount C of the Al2O3-FPU (4) (fluorinated polyurethane) coating is 0.9035 × 10−3 kg, and the anti-wear ability increases by 61.9% compared with FPU-0.5. The water-resistant test shows that the contact angle of water droplets on the surface of the coating increase from 95.3° of FPU-0.5 to 123.1° of Al2O3-FPU (4), and the water absorption decreases from 2.52% to 1.04%. Scanning electron microscopy (SEM) observation confirms that alumina particles can protrude on the coating surface and resist strong wear, while the C-F chain with high bond energy at the near-surface exhibits high strength and water resistance, which prevents wear from spreading deep into the coating. Differential scanning calorimetry (DSC) results show that the Tg(HS) value of the hard segment phase decreases with higher external force. Notably, when the coating is subjected to erosion, which enhances the crystallinity of the hard segment phase, the tensile strength of the hard segment phase of the coating surface is improved, which supports the wear resistance. Herein, we show that the addition of nano-alumina to fluorinated polyurethanes can control high water and abrasion resistance.