Novel 3-D Printed Implant for Improved Hemodialysis Access

项目总结/摘要 这个直接进入第二阶段SBIR提案的总体目标是开发方舟，一种用于 在血液透析针的放置过程中提供改进的接近、保护和功能。在 仅在美国，就有超过700，000名患者接受血液透析治疗， 瘘管（AVF）和入路静脉是透析针的首选入路点。大多数的静脉 从以下缺点：长等待期成熟;具有挑战性的访问;容易损坏 通过针穿透血管;和有限的使用寿命，失败主要是因为过度 和糟糕的穿刺。因此，许多透析患者没有接受透析所需的治疗。 持续的生活质量。 该方舟旨在弥补目前做法的局限性，并帮助长期使用 进入静脉。方舟预期用于入路静脉周围的手术植入，理想情况是在 AVF创建。基础结构促进周围软组织向内生长，增强强度 同时提供一个便于针头进入的开口和一个用于保护血管的后壁 无意中的渗透。植入物在皮肤下提供可触知的结构， 更准确的针穿刺，提高护理人员的效率和患者的舒适度。初始原型 方舟已经通过了初步的实验台和动物研究，证明了可行性， 重大承诺。将继续努力，在这些结果的基础上优化设计， 在相关AVF动物模型中进行插管研究，完成所需的设计控制和确认 活动，并进行长期GLP研究，支持计划提交FDA批准。我们 我希望这项努力的最终结果将大大促进向家庭透析的转变， 对患者健康和卫生保健成本节约具有显著影响。

Project Summary/Abstract The overall goal of this Direct to Phase II SBIR proposal is to develop the Ark, a novel device for providing improved access, protection, and functionality during placement of hemodialysis needles. In the US alone, over 700,000 patients receive hemodialysis treatment, and creation of an arteriovenous fistula (AVF) and access vein is the preferred access point for dialysis needles. Most access veins suffer from the following shortcomings: long waiting periods to mature; challenging to access; prone to damage by needle penetration through the vessel; and limited useful life, failing largely because of both excessive and poor punctures. As a result, many dialysis patients do not receive the treatment required for continued quality of life. The Ark is designed to remediate the limitations of the current practice and aid long-term use of access veins. The Ark is intended for surgical implantation around the access vein, ideally at the time of AVF creation. The infrastructure promotes ingrowth of surrounding soft tissues reinforcing the strength of the vein, while providing an opening for easy needle access and a back wall for vessel protection from inadvertent penetration. The implant provides a palpable structure beneath the skin, promoting more accurate needle puncture, improving both caregiver efficacy and patient comfort. Initial prototypes of the Ark have gone through preliminary benchtop and animal studies demonstrating feasibility and significant promise. Continued efforts will build on these results to optimize the design, perform cannulation studies in a relevant AVF animal model, complete required design controls and validation activities, and perform a chronic GLP study, supporting a planned submission for FDA Clearance. We expect the end result of this effort will greatly facilitate the move toward home-based dialysis, resulting in significant impact on patient health and health care cost savings.