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

基本信息

批准号：
10222783
负责人：
Ashok Gowda
金额：
$ 135.83万
依托单位：
BIOTEX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-24 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10222783
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 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

项目摘要

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.

项目概要/摘要这项直接进入第二阶段 SBIR 提案的总体目标是开发 Ark，一种用于在放置血液透析针期间提供更好的通路、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，并建立了动静脉通道瘘管 (AVF) 和静脉通路是透析针的首选接入点。大多数通路静脉都会受到影响存在以下缺点：成熟等待时间长；访问具有挑战性；容易损坏通过针刺入血管；和有限的使用寿命，失败很大程度上是因为过度和不良的刺破。结果，许多透析患者没有接受透析所需的治疗。持续的生活质量。方舟旨在弥补当前实践的局限性并帮助长期使用进入静脉。方舟旨在用于手术植入周围静脉，最好是在 AVF 创建。基础设施促进周围软组织向内生长，增强强度静脉，同时提供方便针头进入的开口和用于保护血管的后壁来自不经意的渗透。植入物在皮肤下提供了一个可触及的结构，促进更准确的针穿刺，提高护理人员的效率和患者的舒适度。最初的原型方舟已经通过了初步的台式和动物研究，证明了可行性和重大承诺。我们将继续努力以这些结果为基础，优化设计、执行在相关 AVF 动物模型中进行插管研究，完成所需的设计控制和验证活动，并进行长期 GLP 研究，支持计划提交 FDA 许可。我们预计这一努力的最终结果将极大地促进家庭透析的发展，从而对患者健康和节省医疗费用产生重大影响。