Product and Regulatory Development of a Needle-Free Hemodialysis Access Port

无针血液透析输液港的产品和法规开发 项目摘要 目标：SBIR第IIB阶段桥梁奖项目的总体目标是推进一种新的无针 血液透析输液港进入IDE批准阶段，用于随后的首次人体研究。 意义：对于美国近500，000例接受血液透析的终末期肾病（ESRD）肾衰竭患者 (HD)需要每周三次的门诊治疗，需要使用大型透析针（最大2 mm）进行插管 直径）是耗时的、痛苦的和令人不快的，并且使得维持可靠的血管进入部位变得困难 极具挑战性。由于已建立的永久性血管通路方法的高失败率- 动静脉（AV）瘘和AV移植物-超过所有第一年血液透析患者的一半，超过20% 长期的，通过易感染的导管治疗。住院治疗频繁，费用不可持续 对医疗保健系统和大多数病人的生活质量来说都很糟糕。 家庭HD治疗每名患者每年可节省20，000美元，可在患者方便时进行， 改善患者健康，并使许多患者能够继续生产，这是生活质量的主要好处 就业病人调查指出，针头厌恶是增加家庭自我治疗的最大障碍。一个新 克服这一障碍的接入选项将鼓励增加家庭高清。 创新：之前提供钝性插管进入AV移植物管腔的经皮输液港器械 功能和患者赞赏，但最终因出口感染问题而在临床和商业上失败 移植物的位置和通畅性差。Healionics已经开发出技术，通过使用其 组织界面处的星星多孔生物材料，能够重新引入无针HD入路端口概念。 星星的优化孔隙几何形状诱导了一个永久血管化的组织界面， 天然防御细菌感染。将星星应用于AV移植物的外部， 收缩力，保持移植物壁的柔韧性，防止进行性静脉末端的常见失效模式 新生内膜增生止血阀设计和其他组件的改进预计将 与早期的端口设备相比，进一步提高了可靠性和安全性。 方法：该项目的具体目标是：1）扩展原型开发和完成初始临床前测试 根据R44 HL 26256进行更完整的器件设计，2）进行正式的技术验证， 开发、可靠性测试和临床前研究，以及3）准备并提交成功的IDE申请， FDA。IDE批准将允许在SBIR结束后不久开始首次人体早期可行性研究 第二B阶段项目期间，由SBIR项目期间获得的投资资金支持。 影响：项目的成功将使高风险导管的使用显著减少，并避免 增加在家自我照顾的主要障碍。这将大大降低肾衰竭护理的成本， 患者安全和生活质量的重要部分ESRD患者人群。 v0.34

Product and Regulatory Development of a Needle-Free Hemodialysis Access Port PROJECT SUMMARY Objective: The overall objective of this SBIR Phase IIB Bridge Award project is to advance a new Needle-Free Hemodialysis Access Port to the stage of IDE approval for a subsequent first in Human study. Significance: For the nearly 500,000 End Stage Renal Disease (ESRD) kidney failure patients in the US on hemodialysis (HD), the need for thrice-weekly in-clinic treatments requiring cannulation by large dialysis needles (up to 2 mm diameter) is time consuming, painful and unpleasant and makes maintenance of a reliable vascular access site extremely challenging. As a result of high failure rates with the established permanent vascular access methods – arteriovenous (AV) fistulas and AV grafts – more than half of all first-year hemodialysis patients, and more than 20% longer term, are treated via infection-prone catheters. There are frequent hospitalizations with unsustainable costs to the healthcare system and a miserable quality of life for most patients. Home HD treatment saves $20,000 per patient year, can be done at the patient’s convenience, significantly improves patient health, and has the major quality-of-life benefit of enabling many patients to continue productive employment. Patient surveys cite needle aversion as the biggest obstacle to increased home self-treatment. A new access option that overcomes this barrier would encourage increased home HD. Innovation: Previous percutaneous port devices providing blunt cannula access to the lumen of an AV graft were functional and patient-appreciated but eventually failed clinically and commercially from infection issues at the exit site and poor patency of the grafts. Healionics has developed technologies that overcome these issues by use of its STAR porous biomaterial at tissue interfaces, enabling a reintroduction of the needle-free HD access port concept. STAR’s optimized pore geometry induces a permanently vascularized tissue interface that leverages the body’s natural defenses against bacterial infection. Application of STAR to the outside of an AV graft eliminates capsular contraction forces, preserving graft wall flexibility and preventing the usual failure mode of progressive venous-end neointimal hyperplasia. Improvements to the hemostasis valve design and other components are expected to further improve reliability and safety versus earlier port devices. Approach: Specific aims for the project are 1) extend the prototype development and initial preclinical testing done under R44HL26256 into a more complete device design, 2) conduct formal technical verification, fabrication process development, reliability testing and preclinical studies, and 3) prepare and submit a successful IDE application to the FDA. IDE approval will allow a first-in-human Early Feasibility Study to begin soon after conclusion of the SBIR Phase IIB project period, supported by investment funding secured during the SBIR project period. Impact: Project success would enable significant reductions in the use of high-risk catheters and circumvent the main barrier to increased self-care at home. This would greatly reduce the cost of kidney failure care and improve patient safety and quality of life for a significant part of the ESRD patient population. v0.34