Novel 3-D Printed Implant for Improved Hemodialysis Access

项目摘要/摘要 这项直接到第二阶段SBIR计划的总体目标是开发方舟，这是一种用于 在放置血液透析针期间提供更好的访问、保护和功能。在……里面 仅在美国，就有超过70万名患者接受血液透析治疗，并建立了动静脉系统 瘘管(AVF)和通路静脉是透析针的首选接入点。大多数入口静脉都会受到影响 来自以下缺点：成熟等待时间长；访问具有挑战性；容易损坏 通过针穿过血管；以及有限的使用寿命，失败的主要原因是 和糟糕的刺伤。因此，许多透析患者得不到所需的治疗。 持续的生活质量。 方舟的设计是为了弥补目前做法的局限性，并帮助长期使用 进入静脉。方舟的目的是在通路静脉周围进行外科植入，理想情况下是在 AVF创建。基础设施促进周围软组织向内生长，增强力量 静脉，同时提供便于针头接触的开口和用于保护血管的后壁 来自不经意间的渗透。植入物在皮肤下提供了一个可触摸的结构，促进了 更准确的穿刺针，提高了护理者的疗效和患者的舒适度。初始原型 已经通过了初步的桌面和动物研究，证明了可行性和 重要的承诺。将在这些结果的基础上继续努力，以优化设计、执行 相关动静脉瘘动物模型的插管研究，完成所需的设计控制和验证 活动，并进行长期的GLP研究，支持计划提交FDA批准。我们 预计这一努力的最终结果将极大地促进向家庭透析的转变，从而 在很大程度上影响了患者的健康和医疗成本的节约。

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.