Faraday, a Novel Automated Peritoneal Dialysis Device with Dialysate Customization

项目摘要 目前在地球仪上有超过326，000名患者接受腹膜透析（PD）。临床结局 主要取决于每次治疗中使用的葡萄糖和钠浓度。然而，目前的技术水平 APD系统中的葡萄糖浓度严重不足：临床医生必须从仅3种透析液葡萄糖浓度中进行选择 没有钠浓度的选择。虽然研究人员已经广泛发表了 限制葡萄糖暴露以延长腹膜的寿命，没有APD器械允许用户输送 中间葡萄糖浓度。此外，最近的证据表明，高血压PD患者（增加） 至80%的PD人群）可以从降低透析液钠浓度中获益， 从血液中排出钠并改善血压。 为了显著改善最佳PD治疗的临床选择，Simergent提出了法拉第™： 自动腹膜透析（APD）装置，其能够实现个体化的葡萄糖节约和钠 通过创建改善心脏功能所需的按需定制溶液浓度， 结果和延长膜功能。在第一阶段SBIR项目中，我们将开发一种APD泵， 发动机原型，将采取病人自己的家庭自来水，消毒，然后准确地混合它与一个， 四个额外来源。我们的技术的一个巨大的附带好处是，它的使用可以减少运输， 通过将浓缩透析液溶液与无菌溶液混合， 在患者家中产生的水。 具体目标1：创建混合一次性管路套件的原型：设计和制造一次性管路套件 能够混合来自5个来源的流体并输送至混合袋的盒和相关管路套件。 具体目标2：APD泵送发动机样机的制造和试验：设计和制造一台 功能原型硬件和软件系统，以与盒接口并验证体积 精度≤ 1.5%。 具体目标3：创建可定制的钠浓度：设计并演示一种机制， 将准确混合低钠透析液和高渗盐水（2种来源），以产生钠浓度 范围为100 - 170 mmol/l，增量为10 mmol/l，以支持个性化钠调节治疗。 具体目标4：创建可定制的葡萄糖浓度：设计并演示一种机制， 将准确混合5种来源：浓缩透析液（2种葡萄糖浓度），缓冲液， 生理盐水和无菌水，以产生范围为1.0%至4.5%葡萄糖的溶液，增量为0.25%。 我们的第一阶段可行性结果将最终在一个革命性的原型演示子系统， 混合来自不同来源的流体。在第二阶段，我们将把它集成到一个功能齐全的APD设备中。

PROJECT SUMMARY There are currently over 326,000 patients on peritoneal dialysis (PD) around the globe. Clinical outcomes are dictated largely by the dextrose and sodium concentrations used in each session. However, the state of the art in APD systems is woefully deficient: clinicians must choose from only 3 dialysate dextrose concentrations available and have no choice for sodium concentration. While researchers have widely published the benefits of limiting glucose exposure to prolong the life of the peritoneal membrane, no APD device allows users to deliver an intermediate dextrose concentration. In addition, recent evidence suggests that hypertensive PD patients (up to 80% of the PD population) could benefit from a reduced dialysate sodium concentration to remove excess sodium from the bloodstream and improve blood pressure. To dramatically improve the clinical options for optimal PD therapy, Simergent proposes the Faraday™: an automated peritoneal dialysis (APD) device which can enable individualized glucose sparing and sodium adjustment therapies by creating on-demand custom solution concentrations needed to improve cardiac outcomes and prolong membrane function. In this Phase I SBIR project, we will develop an APD pumping engine prototype that will take the patient’s own home tap water, sterilize it, then accurately admix it with one to four additional sources. An enormous side benefit of our technology is that its use can reduce the shipping, storage, and lifting burden of dialysate bags by 92% by mixing concentrated dialysate solutions with sterile water generated at the patient’s home. Specific Aim 1: Create a prototype admixing disposable tubing set: Design and manufacture a disposable cassette and associated tubing set capable of admixing fluids from 5 sources and delivering to a mixing bag. Specific Aim 2: Manufacture and test working APD pumping engine prototype: Design and manufacture a functioning prototype hardware & software system to interface with the cassette and validate the volumetric accuracy is ≤1.5%. Specific Aim 3: Create customizable sodium concentrations: Design and demonstrate a mechanism which will accurately admix low-sodium dialysate and hypertonic saline (2 sources) to create sodium concentrations ranging from 100 to 170 mmol/l in increments of 10 mmol/l to support personalized sodium adjustment therapies. Specific Aim 4: Create customizable dextrose concentrations: Design and demonstrate a mechanism which will accurately admix 5 sources: concentrated dialysate solution (2 dextrose concentrations), buffer solution, saline, and sterile water to create solutions ranging from 1.0% to 4.5% dextrose in increments of 0.25%. Our Phase I feasibility results will culminate in a revolutionary prototype demonstration subsystem critical for admixing fluids from disparate sources. In Phase II, we will integrate this into a fully functioning APD device.