Reducing Infection in Indwelling Medical Devices
DESCRIPTION (Verbatim from the Applicant's Abstract): Urethral catheters are
essential in the management of many diseases and conditions yet often result in
catheter associated urinary tract infections. The use of sterile closed
systems, advanced infection control protocols, and antimicrobial parts has not
prevented infection or the associated morbidity increase. Additionally, direct
patient care costs for these infections exceed $0.5billion annually. Our novel
ironically bonded antimicrobial coating shows promise for the long-term
prevention of infection in urethral catheters. This research will establish
that unlike conventional systems where the antimicrobial agent is entrapped in
a matrix and acts through diffusion, our antimicrobial agents are ionically
bonded to a polymeric backbone. The release mechanism is one of ion exchange
and is not purely diffusional. The effectiveness is thus sustainable for a long
period. Initial work will establish antimicrobial activity as a function of time
against four organisms characteristic of nosocomial urinary tract infections.
The method of release will be established by comparing the results of three
different measures of antimicrobial activity, namely, the zone of inhibition
and bacterial adherence tests. Preliminary biocompatibility tests and coating
integrity will be conducted as well. Coating effectiveness greater than 1 week
will justify further in vivo investigations.
PROPOSED COMMERCIAL APPLICATION:
Urethral catheters that effectively reduce the incidence of infection in long-term use have
great market potential due to the reduction in mortality, morbidity, and direct patient costs.
For instance, the direct patient costs associated with the treatment of catheter associated
urinary tract infections exceeds $0.5 billion annually. The success of Bard's hydrogel/silver
Foley catheter demonstrates that the medical and insurance communities would be highly
receptive to reasonably priced products that significantly reduces the incidence of
nosocomial urinary tract infections. While advances in infection control procedures and
medical devices have reduced the overall incidence of catheter associated urinary tract
infections, in long term (> one week) catheterizations there is a greater than 50% chance
that those patients will acquire a sometimes anti-biotic resistant infection. There are no
products that are effective for more than 1 week. Preliminary results have shown that our
antimicrobial coating is effective for as long as 30 days, a four-fold increase over any other
commercially available product. Since our coating does not alter the physical characteristics
of the base material or product, acceptance by the medical device community once safety and
efficacy is established should be achievable with appropriate business development efforts.
Small Business Information at Submission:
Principal Investigator:Tungliang Lin
AST PRODUCTS, INC.
9 LINNELL CIR BILLERICA, MA 01821
Number of Employees: