Delayed Onset of Biofilm Formation and CAUTI with Superhydrophobic Catheters

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43FD004024-01A1
Agency Tracking Number: R43FD004024
Amount: $150,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2011
Solicitation Year: 2011
Solicitation Topic Code: FDA
Solicitation Number: PA11-096
Small Business Information
LYNNTECH, INC., 2501 Earl Rudder Freeway South, COLLEGE STATION, TX, 77845-
DUNS: 184758308
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (979) 764-2200
Business Contact
Phone: (979) 764-2200
Research Institution
DESCRIPTION (provided by applicant): Catheter-associated urinary tract infections (CAUTI) occur in gt40and of the 21-50% patients that are administered indwelling catheters, annually costing a staggering 421- 451 million in medical intervention, antimicrobial treatments and frequent catheter replacements in the US alone. Increased patient trauma cannot be overlooked: when a CAUTI episode becomes symptomatic, the resulting sequelae can range from mild (fever, urethritis and cystitis) to severe (acute pyelonephritis, renal scarring, calculu formation and bacteremia). Organisms that lead to a CAUTI gain access in one of two ways: through the external lumen of the catheter or through the internal lumen. Attempts at mitigating CAUTIs, which have shown better efficacy extraluminally than intraluminally, have been directed at developing antimicrobial action on the catheter surface: (i) silver alloy urinary catheters are prone to antimicrobial resistance development; (ii) antimicrobial- impregnated catheters using several drugs/drug combinations elicit yet-to-be-established confidence in their efficacy. The root cause lies in the early onset of contamination where adhesion of bacteria to the catheter surface initiates a cascade of events (protein syntheses, etc.) leading to development of antibiotic resistance and the formation of thick biofilms. Two important consequences must be recognized: i) leaching of antibiotic- resistant bacterial into the bladder can cause serious infections, and; ii) attempts to control bacterial proliferation by means of antimicrobial action o the surface will constantly prove to be ineffective (as observed). With over 1 million cases of CAUTI reported in the United States annually, the claim that this is an area of high medical concern is not far-fetched. Therefore, the introduction of a new catheter technology with the potential to induce a sustainable paradigm shift that overcomes the limitations of the current state-of-the-art is warranted. This proposed Phase I SBIR effort is specifically designed to address the above challenge. In this effort, we propose a new superhydrophobic catheter technology. The prevalent hypothesis is that instead of moot attempts to control adhered, drug-resistant bacteria, catheters with super-hydrophobic internal surface should allow natural flow of urine to efficiently wash-off any adhered bacteria and exhibit minimal accommodation to new colonizing bacteria, thereby delaying bacterial proliferation, bio-film formation and subsequent complications. During thisPhase I project, our overall goal is to demonstrate proof-of-concept delayed onset of bio-film formation by pursuing a series of specific aims, namely: (i) a uropathogen-inhospitable catheter internal lumen; (ii) optimized coating strength and stability, and; (iii) improved catheter functional lifetime Improved catheter functional lifetime. Successful completion of these specific aims should demonstrate ample feasibility of this catheter technology platform and should allow us to plan more comprehensive technology development and commercialization thrusts, in addition to exploration of other applied models in a follow-on Phase II effort. PUBLIC HEALTH RELEVANCE: We propose to generate and validate a catheter technology that exhibits prevention overcure: a coating formulation and mechanism that prevents adhesion of bacteria, which eventually develop antibiotic resistance and cause severe infections, to the catheter surface over state-of-the-art catheters with antimicrobial surfaces. Benefits derivedshould decrease healthcare costs, decrease infection and mortality rates and improve overall patient quality-of-life.

* Information listed above is at the time of submission. *

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