A silicon nanopore membrane blood filter enabling anticoagulant free continuous renal replacement therapy for acute kidney injury

硅纳米孔膜血液过滤器可实现无抗凝剂的连续肾脏替代治疗急性肾损伤

• 批准号: 10546997
• 负责人: Charles Blaha
• 金额: $ 102万
• 依托单位: SILICON KIDNEY, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-19 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10546997
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Albumins; Animal Model; Anticoagulants; Anticoagulation; Area; Blood; Blood flow; Citrates; Clinical; Clinical Research; Clinical Trials; Coagulation Process; Complex; Critical Illness; Devices; Dose; Fiber; Film; Future; Hemodialysis; Hemolysis; Hemorrhage; Heparin; Hour; Implant; In Vitro; Intensive Care Units; International; Kidney; Legal patent; Length; Liquid substance; Marketing; Mechanics; Membrane; Notification; Patient Admission; Patient-Focused Outcomes; Patients; Permeability; Phase; Polymers; Preparation; Renal Replacement Therapy; Risk; Risk Reduction; Sepsis; Silicon; Small Business Innovation Research Grant; Sterilization; Surface; Surveys; System; Techniques; Technology; Testing; Thinness; Toxin; Urea; Uremia; Validation; Work; biomaterial compatibility; blood filter; commercialization; cost; design; hemocompatibility; hemodynamics; heparin-induced thrombocytopenia; hypoperfusion; improved; nanopore; porcine model; pre-clinical; prototype; research clinical testing

Project Summary Acute Kidney Injury (AKI) commonly occurs in critically ill patients in the ICU. Patients with severe AKI often require continuous renal replacement therapy (CRRT) because it enables hemodynamic stability and better volume control. Anticoagulation therapy is frequently used to keep the CRRT circuit (especially the blood filter) from clotting as many critically ill patients are prothrombotic, and/or when CRRT is commonly performed for multiple days. However, both systemic heparin and regional citrate anticoagulation therapy are associated with higher costs, increased circuit complexity, and complications. Consequently, we propose to develop an anticoagulant-free blood filter (the HemoCartridge) based on the ultra-high-flux and blood compatible silicon nanopore membrane (SNM) technology for extended extracorporeal applications. The HemoCartridge will operate clot free with little to no anticoagulation for the length of a CRRT session to eliminate the costs, complexity, and complications of administering anticoagulation therapy, reduce blood loss, reduce the cost of CRRT due to filter clotting and replacement, and reduce the risk of not delivering an adequate dialytic dose to the critically ill AKI patient. In this SBIR Phase II proposal, we will develop a clinical-scale HemoCartridge and then assess uremic toxin clearance and hemocompatibility on the bench top and in the anephric porcine model.

项目概要 急性肾损伤（AKI）通常发生在 ICU 的重症患者中。患有严重 AKI 的患者经常 需要连续性肾脏替代治疗（CRRT），因为它可以实现血流动力学稳定性和更好的效果 音量控制。抗凝治疗常用于维持 CRRT 回路（尤其是血液过滤器） 由于许多危重患者处于血栓前状态，和/或通常进行 CRRT 治疗时，可能会导致凝血 多日。然而，全身肝素和局部柠檬酸盐抗凝治疗均与 更高的成本、增加的电路复杂性和并发症。因此，我们建议开发一个 基于超高通量和血液相容性硅的无抗凝血液过滤器（HemoCartridge） 用于扩展体外应用的纳米孔膜 (SNM) 技术。 HemoCartridge 将 在 CRRT 疗程期间进行无凝块操作，几乎不进行抗凝治疗，以消除成本， 抗凝治疗的复杂性和并发症，减少失血量，降低治疗费用 由于过滤器凝结和更换而进行 CRRT，并降低无法向患者提供足够透析剂量的风险 危重 AKI 患者。在这个 SBIR II 期提案中，我们将开发临床规模的 HemoCartridge 和 然后评估实验室和无肾病猪的尿毒症毒素清除率和血液相容性 模型。