Venous Window Access Catheter For Hemodialysis

描述（由申请人提供）：一种新型静脉窗入路器械（VWAD）、吻合工具和微创、图像引导外科手术，用于为终末期肾病（ESRD）患者提供血液透析，已经历早期开发阶段。该器械可用作目的地治疗或“桥接器械”，以在动静脉（AV）瘘成熟期间提供临时通路。该器械由一个与中心静脉（即右颈静脉）相连的经皮穿刺导管组成，用作经皮穿刺端口。通过将双腔一次性导管沿通路导管向下推进并进入静脉进行透析（每周三次）。当不使用时，经皮进入导管用抗菌溶液回填，并通过闭塞闭塞器与循环完全隔离。在透析疗程之间取出并更换一次性闭孔器。该技术具有几个优点：1）与传统的留置透析导管相反，将进入导管吻合到静脉外部允许装置驻留在静脉中的连续血液路径外部。2)该器械的“外宿”配置将减少血栓、健康静脉狭窄以及与窦道血液连通的可能性。初步的体外和体内研究已经确定了将该系统减少到临床实践所需的程序和设计改进。本SBIR快速通道提案的目的是完成临床配置设计、构建原型、执行体外性能和安全性测试，并验证绵羊体内长期植入物的体内性能。该项目将完成临床配置的开发，并为II期临床试验和最终监管提交做好准备，从而实现该概念的商业化。

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.