Venous Window Access Catheter For Hemodialysis

描述（由申请人提供）：一种新型静脉窗通道装置（VWAD）、吻合工具和微创影像引导手术为终末期肾病（ESRD）患者提供血液透析的方法已经处于早期发展阶段。该装置可以作为目的治疗或作为“桥式装置”，在动静脉（AV）瘘成熟期间提供临时通道。该装置包括一个经皮通路导管，与中心静脉吻合，即右颈静脉，作为经皮通路口。透析（每周三次）是通过将双腔一次性导管沿通道进入静脉进行的。当不使用时，经皮导管回充抗菌溶液，并通过闭塞的闭孔器与循环完全隔离。在透析期间取下并更换一次性闭孔器。该技术有以下几个优点：1)与传统的留置透析导管相反，将导管与静脉外部的吻合使得该装置可以驻留在静脉内连续的血液路径之外。2)该装置的“外置”配置将减少血栓、健康静脉狭窄，以及血液与窦道沟通的可能性。初步的体外和体内研究已经确定了将该系统用于临床实践所需的程序和设计改进。该SBIR快速通道提案的目标是完成临床配置设计，构建原型，进行体外性能和安全性测试，并通过绵羊慢性植入物验证体内性能。该项目将允许完成临床配置的开发，为II期临床测试和最终监管提交做准备，从而实现这一概念的商业化。

DESCRIPTION (provided by applicant): A novel, venous window access device (VWAD), anastomotic tool, and minimally invasive, image-guided surgical procedure to provide hemodialysis for patients suffering from End Stage Renal Disease (ESRD) have undergone early stage development. The device can serve as a destination therapy or as a "bridge device" to provide temporary access during maturation of an arteriovenous (AV) fistula. The device consists of a percutaneous access conduit, anastomosed to a central vein, i.e. the right jugular vein, that serves as an percutaneous access port. Dialysis is performed (three times weekly) by advancing a dual lumen, disposable catheter down the access conduit and into the vein. When not in use, the percutaneous access conduit is back filled with anti-microbial solution and is completely isolated from the circulation by an occluding obturator. The disposable obturator is removed and replaced between dialysis sessions. The technology has several advantages: 1) Anastomosis of the access conduit to the outside of the vein allows the device to reside outside the continuous blood path in the vein, as opposed to conventional, indwelling dialysis catheters. 2) The "outdwelling" configuration of this device will reduce thrombus, stenosis of the healthy vein, and potential for blood communication with the sinus tract. Preliminary in vitro and in vivo studies have identified procedural and design improvements required to reduce this system to clinical practice. The objective of this SBIR fast track proposal is to complete the clinical configuration design, build prototypes, perform in vitro performance and safety testing, and verify in vivo performance with chronic implants in sheep. This project will allow completion of development of a clinical configuration and prepare for Phase II clinical testing and final regulatory submission leading to commercialization of this concept.