Faraday, a Novel Automated Peritoneal Dialysis Device with Dialysate Customization

项目总结 在全球超过326,000名腹膜透析(PD)患者中，高达80%患有高血压，56% 会死于心血管疾病。临床结果在很大程度上取决于葡萄糖和钠 每种处理中使用的浓度。然而，apd系统的灵活性严重不足。而当 限制葡萄糖暴露以延长腹膜寿命的好处是已知的，没有apd设备允许 使使用者的葡萄糖浓度逐渐降低。最近的证据表明，高血压帕金森病 患者可以从目前无法获得的减少透析液钠混合物来清除多余的透析液中受益。 从血液中摄取钠并改善血压。最近宣布的高级美国人肾脏 健康倡议(AAKHI)呼吁到2025年80%的ESRD新患者接受家庭透析或移植， 这将导致使用PD的透析患者从10%增加到~50%。 我们在第一阶段™项目中创建的创新的法拉第SBIR APD技术使混合PD疗法成为可能 这可以去除血液中多余的钠，同时最大限度地减少葡萄糖的暴露。我们已经开发出一种 台式apd泵送发动机原型，通过一个 专有的卡带和气动系统。我们的第二阶段开发将以一个功能齐全的 可商业化、用户友好的apd设备和自来水过滤系统，具有定制疗法，旨在 显著减少心血管死亡和早期PD技术失败。 具体目标1：与FDA共同开发调控途径：我们的目标是开发设计历史文件 并在分组前会议上与FDA会面，以确保他们同意我们的预测设备--水灭菌 需求、产品架构、高级风险缓解和安全系统。 具体目标2：优化现有泵送发动机：。盒式磁带和气动歧管将是 小型化，并将开发一种盒式磁带到硬件门的接口机构。流速测试将 使用优化的泵送发动机确认流量&gt；190毫升/分钟灌装和&gt；125毫升/分钟排放。 具体目标3：将泵送引擎集成到功能齐全的apd自行车中：所有硬件元素都将 在桌面大小的便携式外壳中进行了优化，以创建一种精度为1.5%的设备。我们会 开发一流的用户界面，具有设置动画和直观的治疗编程和操作。 具体目标4：开发净水系统：我们将设计和建造一个水过滤和杀菌系统 系统将创建注射用水以满足FDA对TVC&lt；0.1cfu/ml、内毒素无菌的要求 &lt；0.1EU/ml(95%置信度)，以及符合国际标准化组织23500和美国标准1231&gt；的化学污染物。 我们的第二阶段开发将最终形成一种可商业化的、用户友好的台式apd设备，带有钠 以及旨在减少心血管死亡和早期帕金森病技术失败的葡萄糖定制雪崩疗法。

PROJECT SUMMARY Up to 80% of the over 326,000 patients on peritoneal dialysis (PD) around the globe have hypertension and 56% will die due to cardiovascular issues. Clinical outcomes are dictated largely by the dextrose and sodium concentrations used in each treatment. However, the flexibility of APD systems is woefully deficient. While the benefits of limiting glucose exposure to extend the life of the peritoneum are known, no APD device allows users to deliver a gradually decreasing dextrose concentration. Recent evidence shows that hypertensive PD patients could benefit from a currently unavailable reduced dialysate sodium admixture to remove excess sodium from the blood and improve blood pressure. The recently announced Advanced American Kidney Health Initiative (AAKHI) calls for 80% of new ESRD patients in 2025 to receive home dialysis or a transplant, which will result in an increase from 10% to ~50% of dialysis patients using PD. Our innovative Faraday™ APD technology created in a Phase I SBIR project enables admixing PD therapies that remove excess sodium in the bloodstream while minimizing dextrose exposure. We have developed a benchtop APD pumping engine prototype that accurately admixes custom solutions from five input fluids via a proprietary cassette and pneumatics. Our Phase II development will culminate in a fully functioning, commercializable, user-friendly APD device and tap water filtration system with custom therapies designed to drastically reduce cardiovascular deaths and early PD technique failure. Specific Aim 1: Develop regulatory pathway with FDA: Our goal is to develop design history file documents and meet with the FDA in a pre-sub meeting to ensure they agree with our predicate device, water sterilization requirements, product architecture, high-level risk mitigations, and safety systems. Specific Aim 2: Optimize current pumping engine:. The cassette and pneumatics manifold will be miniaturized, and a cassette-to-hardware door interface mechanism will be developed. Flow rate testing will confirm flow rates >190 ml/min Fill and >125 ml/min Drain with the optimized pumping engine. Specific Aim 3: Integrate pumping engine into fully functioning APD cycler: All hardware elements will be optimized in a table-top sized portable enclosure to create a device that admixes at 1.5% accuracy. We will develop a best-in-class UI with setup animations and intuitive therapy programming and operation. Specific Aim 4: Develop water purification system: We will design and build a water filtration and sterilization system to create injection-quality water to meet FDA requirements for sterility of TVC <0.1 CFU/ml, endotoxins <0.1 EU/ml (95% confidence), and chemical contaminants per ISO 23500 and USP <1231>. Our Phase II development will culminate in a commercializable, user-friendly tabletop APD device with sodium and dextrose tailoring APD therapies designed to reduce cardiovascular deaths and early PD technique failure.