Venous Window Access Catheter For Hemodialysis

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.