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。公共卫生相关性：该补助金旨在开发一种新型的血管窗通路装置（VWAD），为需要长期血液透析的ESRD患者提供血管通路。使用超声引导，经皮装置被设计成在导丝上植入，并且“端对侧”地闭合到中央静脉（优选右颈静脉）的外部。该提案包括开发一种用于将器械连接到静脉壁的自动吻合工具。独特的技术翻转并捕获血管壁在“挤压间隙”中，使得其可以在取出期间快速释放。经皮导管用作进入端口，其中在每次透析期间周期性地（每周三次）插入一次性双腔导管。在每次透析过程中移除并更换闭塞性闭孔器。闭孔器将器械与循环隔离，以便VWAD的管腔可以用抗菌封管液冲洗和封管。该器械可植入至少6个月，理想情况下可提供“瘘管桥接”，但可根据患者需求和医生确定的其他因素提供更长期的护理。

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. PUBLIC HEALTH RELEVANCE: This grant is directed toward the development of a novel, vascular windows access device (VWAD) that provides vascular access for ESRD patients requiring chronic hemodialysis. Using ultrasound guidance, the percutaneous device is designed to be implanted over a guide wire, and anastomosed "end to side" to the outside of a central vein, preferably the right jugular vein. This proposal includes development of an automated, anastomotic tool that is used to couple the device to the venous wall. The unique technology everts and captures the vessel wall in a "squeeze gap", such that it can be rapidly released during explant. The percutaneous conduit serves as an access port, wherein a disposable, double lumen catheter is inserted periodically (three times weekly) during each dialysis session. An occlusive obturator is removed and replaced during each dialysis session. The obturator isolates the device from the circulation so that the lumen of the VWAD can be flushed and locked with anti-microbial lock solution. The device is implantable for a minimum of 6 months, ideally to provide a "bridge to fistula," but can provide longer term care based on patient need and other factors determined by the physician.