I-Corps: Medical device to treat liver failure

I-Corps：治疗肝衰竭的医疗设备

• 批准号: 2348688
• 负责人: Dayong Gao
• 金额: $ 5万
• 依托单位: University of Washington
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-11-15 至 2024-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2348688&HistoricalAwards=false
• 关键词: Corps; Medical; device; treat; liver

The broader impact/commercial potential of this I-Corps project is the development of an advanced multi-organ replacement system that initially focuses on treating liver failure. Currently, when the liver fails, liver transplants are the only option for survival, however, only one in ten people who need a liver transplantation receive it. Liver support systems aim to keep patients alive while waiting for their liver to recover or for an organ to become available. However, current liver support systems have not been able to extend life long enough to receive transplantation and survive. The proposed technology may provide treatment for previously untreatable liver and multi-organ failure patients, as well as preventing liver failure during other medical procedures such as gene therapy and surgery for cancerous tumor removal. The goal is to provide a bridge to transplantation, as well as reduce racial and gender disparities in determining who is selected for a transplant. In addition, the proposed technology also may provide support for patients excluded from transplantation. This includes people with insufficient social support for transplantation, or comorbidities such as mental illness or old age that make them poor transplant candidates. The proposed system may extend the potential range of conditions where treatment is possible and may provide transplant-ineligible patients with better healthcare access.This I-Corps project is based on the development of a medical device to treat liver failure by removing protein bound toxins and excess fluid from liver failure patients. The proposed technology uses a hemofiltration method to remove a greater quantity of excess fluid from the patient while using less dialysate. Existing hemofiltration systems are typically predilution, meaning that replacement fluid is added before the blood passes through the dialyzer. This process has the disadvantages of reducing the efficiency of excess fluid removal (because some of what is removed is the newly added replacement fluid) and reducing the efficiency of toxin removal. Post-dilution systems remove more toxin and excess fluid with less waste, but have a risk of coagulation. The proposed recirculation hemofiltration method recirculates a portion of the blood after post-dilution back to a pre-dilution port, which minimizes excessive fluid usage and coagulation risk. This system also includes methods to increase the efficiency of protein-bound toxin removal using albumin dialysis, charcoal, and a rinsing protocol. A prototype of the system achieved 80% 28-day survival in patients where 20% survival was expected due to critical illness. In addition, this may allow an increase in the efficiency of protein bound toxin removal, improving treatment outcomes and bridging patients to transplantation.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这个I-Corps项目的更广泛的影响/商业潜力是开发一种先进的多器官替代系统，最初专注于治疗肝衰竭。目前，当肝脏衰竭时，肝移植是生存的唯一选择，然而，只有十分之一需要肝移植的人接受它。肝脏支持系统旨在让患者在等待肝脏恢复或器官可用时存活。然而，目前的肝脏支持系统还不能延长生命足够长的时间来接受移植和生存。 所提出的技术可以为以前无法治疗的肝脏和多器官衰竭患者提供治疗，以及在其他医疗程序（如基因治疗和癌症肿瘤切除手术）期间预防肝脏衰竭。 其目标是为移植提供一个桥梁，并减少种族和性别差异，以确定谁被选中进行移植。此外，这项技术还可以为被排除在移植之外的患者提供支持。这包括那些对移植缺乏足够社会支持的人，或者患有精神疾病或老年等使他们成为移植候选人的合并症。 拟议的系统可能会扩大潜在的条件范围，其中治疗是可能的，并可能提供移植不合格的患者更好的医疗access.This I-Corps项目是基于医疗设备的开发，以治疗肝衰竭，通过去除蛋白质结合毒素和多余的液体从肝衰竭患者。 拟议的技术使用血液滤过方法，在使用更少透析液的同时从患者体内去除更多多余的液体。现有的血液滤过系统通常是预稀释的，这意味着在血液通过透析器之前添加置换液。这种方法的缺点是降低了过量流体去除的效率（因为一些被去除的是新添加的置换流体）并降低了毒素去除的效率。后稀释系统去除更多的毒素和多余的液体，浪费更少，但有凝结的风险。所提出的再循环血液滤过方法将后稀释后的一部分血液再循环回前稀释端口，从而最大限度地减少了过量液体使用和凝血风险。 该系统还包括使用白蛋白透析、活性炭和冲洗方案来提高蛋白结合毒素去除效率的方法。 该系统的原型实现了80%的患者28天生存率，其中20%的生存率是由于危重疾病。 此外，这可能会提高蛋白结合毒素清除的效率，改善治疗效果，并将患者与移植联系起来。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。