Novel 3-D Printed Implant for Improved Hemodialysis Access

新型 3D 打印植入物可改善血液透析通道

• 批准号: 10081495
• 负责人: Ashok Gowda
• 金额: $ 79.5万
• 依托单位: BIOTEX, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-24 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10081495
• 关键词: 3D Print; Anatomy; Animal Model; Animals; Arteriovenous fistula; Back; Blood; Blood Vessels; Blood flow; Caliber; Cannulations; Caregivers; Characteristics; Chronic; Chronic Kidney Failure; Clinical; Consult; Cost Savings; Device Designs; Devices; Dialysis patients; Dialysis procedure; Engineering; Evaluation; Extravasation; Failure; Frequencies; Goals; Goat; Health Care Costs; Healthcare; Hemodialysis; Histologic; Home environment; Hour; Human; Implant; Improve Access; Industrialization; Infiltration; Infrastructure; Institutes; Life; Limb structure; Measures; Mechanics; Medical; Modeling; Needles; Operative Surgical Procedures; Palpable; Palpation; Patients; Penetration; Phase; Physicians; Protocols documentation; Puncture procedure; Quality of life; Regulatory Pathway; Risk; Safety; Side; Silicones; Site; Skin; Small Business Innovation Research Grant; Structure; Testing; Texas; Time; Tissue Model; Tissues; Titanium; Training; Ultrasonography; Universities; Update; Validation; Variant; Veins; Work; animal data; arm; base; capsule; design; exoskeleton; first-in-human; implantation; improved; meetings; member; metallicity; novel; preclinical study; prevent; product development; prototype; response; soft tissue; success; verification and validation

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.

项目摘要/摘要 直接向II阶段SBIR提案的总体目标是开发ARK，这是一种新颖的设备 在放置血液透析针头期间，提供了改进的访问，保护和功能。在 仅美国，超过700,000名患者接受了血液透析治疗，并创建了动静脉。 瘘管（AVF）和接入静脉是透析针的首选接入点。大多数进入脉正在受苦 从以下缺点开始：长期等待时间到成熟；具有挑战性的访问；容易损坏 通过针穿过容器的针刺；并且有限的使用寿命有限，主要是因为两者过多 和不良的穿刺。结果，许多透析患者没有接受 持续的生活质量。 方舟旨在补充当前实践的局限性，并有助于长期使用 进入静脉。方舟旨在用于访问静脉周围的手术植入，理想情况下 AVF创建。基础设施促进了周围软组织的向内生长，从而增强了强度 静脉的静脉 来自无意的穿透。该植入物在皮肤下方提供明显的结构，促进 更准确的针头穿刺，提高护理人员功效和患者舒适性。初始原型 方舟的台面和动物研究表明可行性和 巨大的希望。继续努力将以这些结果为基础，以优化设计，执行 相关的AVF动物模型，完整必需的设计控制和验证中的插管研究 活动，并进行长期的GLP研究，支持计划中的FDA清除率。我们 期望这项努力的最终结果将极大地促进朝基于家庭的透析的转变，从而 对患者健康和医疗保健成本节省的重大影响。