Venous Window Access Catheter For Hemodialysis

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,057,200.00
Award Year:
2009
Program:
SBIR
Phase:
Phase II
Contract:
4R44CA139608-02
Award Id:
89006
Agency Tracking Number:
CA139608
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
VITAL ACCESS, INC., 2302 PRESIDENTS DR, STE C, SALT LAKE CITY, UT, 84120
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
180346285
Principal Investigator:
STEVEN JOHNSON
() -
Business Contact:
() -
sjohnson@vital-access.com
Research Institution:
n/a
Abstract
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 ea rly 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, stenosi s 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 f ast 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 cl inical configuration and prepare for Phase II clinical testing and final regulatory submission leading to commercialization of this concept.

* information listed above is at the time of submission.

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