A drug releasing urinary catheter

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$750,000.00
Award Year:
2003
Program:
SBIR
Phase:
Phase II
Contract:
2R44DK057918-02
Award Id:
66332
Agency Tracking Number:
DK057918
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
11 MILLER STREET, SOMERVILLE, MA, 02143
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
ROBERTWHALEN
(617) 868-4433
robert@whalen.net
Business Contact:
PAMELAROSENGARD
(617) 868-4433
PAMELA@WHALEN.NET
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): Catheter-associated urinary tract infection (UTIc) is the most common nosocomial infection acquired in hospitals and nursing homes. The goal of this Phase II program is to continue the development and evaluation of a new, drug releasing urinary catheter fabricated from silicone rubber containing the antiseptic agent chlorhexidine gluconate (CHG). The CHG is confined in a polyethylene glycol matrix uniformly dispersed in the elastomer, and it is released in sustained fashion over periods up to 4 weeks. This catheter material has been shown to be effective in vitro against organisms commonly associated with UTI. The choice of CHG as the antiseptic agent is based on its broad spectrum of activity, comparatively low toxicity, and low incidence of the development of bacterial resistance. In Phase II, methods for fabricating the catheters will be refined, and the effectiveness of the catheter material to inhibit or kill bacteria as a function of usage time evaluated. Toxicity studies required to fulfill the requirements of ISO 10993-18, a standard for medical device materials, will be conducted; and the shelf life of the catheters will be determined. Finally, a double blind, randomized trial of drug releasing versus nondrug releasing catheters in a large animal model will be conducted to measure efficacy in lessening or preventing the development of UTIc or pylonephritis over a 28 day period.

* information listed above is at the time of submission.

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