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.
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.
