SBIR-STTR Award

The goal of this Phase I effort is determine the feasibility of developing a unique antimicrobial catheter to reduce the instances of the most prevalent healthcare associated infection, Catheter-Associated Urinary Tract Infection (CAUTI). This research and development effort will be to develop a urinary catheter with inherent long lasting antiseptic properties to protect the patient and prevent infection. The proposed device is a new approach to antimicrobial catheters. It will use common Foley catheter designs and materials, with the addition of an additive to the elastomer to render the catheter antimicrobial. The additive replaces the silica reinforcing filler in the elastomer and is designed to give a long lasting time release of antibacterial agent to the catheter surface. The catheter can be manufactured inexpensively with standard medical tubing manufacturing processes and materials, but will have the value-added property of antimicrobial activity. A durable and effective antimicrobial catheter that can prevent or reduce CAUTI will save millions of dollars in healthcare cost and thousands of lives annually.

Public Health Relevance Statement:


Public Health Relevance:
A top priority of the Health and Human Services and the National Institutes of Health is the elimination of Healthcare Associated Infections (HAI). Catheter-associated urinary tract infection (CAUTI), the most prevalent HAI, is the source of over 30% of all HAI's. There are approximately 560,000 cases of CAUTI resulting an estimated 13,000 deaths annually in the US. The resulting increased hospital stay and increased antibiotic use results in an annual cost of over 0.5 billion dollars to US healthcare.

NIH Spending Category:
Bioengineering; Infectious Diseases; Prevention; Urologic Diseases

Project Terms:
Anti-Bacterial Agents; Antibiotics; antimicrobial; antimicrobial drug; base; carbene; catheter associated UTI; Catheters; Cell Survival; Cessation of life; controlled release; cost; delrin; depolymerization; design; Development; Devices; Dose; Elastomers; FDA approved; Feasibility Studies; Filler; Formaldehyde; Goals; Health Care Costs; Health Priorities; Healthcare; Human; Infection; Infection prevention; innovation; irradiation; Length of Stay; Local Anti-Infective Agents; Manufactured Materials; manufacturing process; Measurement; Measures; Mechanics; Medical; melting; Methenamine; Molds; monomer; novel strategies; Oxides; pathogen; Patients; Phase; physical property; Polymers; prevent; Process; Product Packaging; Property; prototype; public health relevance; research and development; response; Services; Silicon Dioxide; Silicone Elastomers; Source; Sterilization; Surface; Technology; Testing; Time; United States National Institutes of Health; urinary; Urinary tract; Urinary tract infection

The goal of this Phase II effort is bring to market a unique antimicrobial catheter to reduce the instances of the most prevalent healthcare associated infection, Catheter-Associated Urinary Tract Infection (CAUTI). This research and development effort will be to develop a urinary catheter with inherent long lasting antiseptic properties to protect the patient and prevent infection. We have begun the discussions with the FDA and have a clear path of the requirements to complete the regulatory approval process. The proposed device is a new approach to antimicrobial catheters. It will use common Foley catheter designs and materials, with the addition of an additive to the elastomer to render the catheter antimicrobial. The additive replaces the silica reinforcing filler in the elastomer and is designed to give a long lasting time release of antibacterial agent to the catheter surface. The catheter can be manufactured inexpensively with standard medical tubing manufacturing processes and materials, but will have the value-added property of antimicrobial activity. A durable and effective antimicrobial catheter that can prevent or reduce CAUTI will save millions of dollars in healthcare cost and thousands of lives annually.

Public Health Relevance Statement:
A top priority of the Health and Human Services and the National Institutes of Health is the elimination of Healthcare Associated Infections (HAI). Catheter-associated urinary tract infection (CAUTI), the most prevalent HAI, is the source of over 40% of all HAI’s. There are approximately 560,000 cases of CAUTI resulting an estimated 13,000 deaths annually in the US. The resulting increased hospital stay and increased antibiotic use results in an annual cost of over 0.5 billion dollars to US healthcare.

NIH Spending Category:
Bioengineering; Infectious Diseases; Prevention; Urologic Diseases

Project Terms:
Anti-Bacterial Agents; Antibiotics; antimicrobial; antimicrobial drug; base; biomaterial compatibility; carbene; catheter associated UTI; Catheters; Cessation of life; Clinical Trials; commercialization; Contracts; controlled release; cost; delrin; depolymerization; design; Development; Devices; Elastomers; FDA approved; Filler; Formaldehyde; Goals; Guidelines; Health Care Costs; Health Priorities; Healthcare; Human; Infection; Infection prevention; Injection of therapeutic agent; innovation; irritation; Legal patent; Length of Stay; Licensing; Liquid substance; Local Anti-Infective Agents; Manufactured Materials; Manufacturer Name; manufacturing process; Marketing; Medical; Medical Device; meetings; Membrane; Methenamine; Molds; monomer; Mucous body substance; novel strategies; Oxides; pathogen; Patients; performance tests; Phase; Polymers; prevent; Process; Property; prototype; research and development; Services; Silicon Dioxide; Silicone Elastomers; Source; Sterilization; Surface; Technology; Testing; Time; United States National Institutes of Health; urinary; Urinary tract; Urinary tract infection; Uropathogen; Validation; Wor