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Control of Biofilm-embedded Organisms

Technology Benefits

- NAC is a clinically-approved, safe, and low-cost compound. For example, high dose NAC is commonly used to treat acetaminophen overdose in both adults and children.- Substantially removes biofilm, prevents its growth from the surface of medical devices, permits disruption of biofilm, and allows penetration of other antifungal/antimicrobial agents.- Provides anti-biofilm coating methods for medical devices.- Validated safety and efficacy by a successful human clinical trial and other studies.

Detailed Technology Description

Publications:1. Role of antibiofilm-antimicrobial agents in controlling device-related infections. Aslam S, Darouiche RO. Int J Artif Organs. 2011 Sep;34(9):752-8.2. Mechanical integrity of hemodialysis catheters after exposure to a novel catheter lock solution. Aslam S, Darouiche RO. Infect Control Hosp Epidemiol. 2010 Nov;31(11):1124-9.3. Pilot trial of N-acetylcysteine and tigecycline as a catheter-lock solution for treatment of hemodialysis catheter-associated bacteremia. Aslam S, Trautner BW, Ramanathan V, Darouiche RO. Infect Control Hosp Epidemiol. 2008 Sep;29(9):894-7.

Supplementary Information

Inventor: Darouiche, Rabih O.
Priority Number: US6475434B1
IPC Current: A61L000200 | A61L002728 | A61L002908 | A61L002916 | A61L003108
US Class: 422028 | 422035 | 4270021
Assignee Applicant: Baylor College of Medicine,Houston
Title: Composition and methods for preventing and removing biofilm embedded microorganisms from the surface of medical devices
Usefulness: Composition and methods for preventing and removing biofilm embedded microorganisms from the surface of medical devices
Summary: The compositions are used to prevent the growth or proliferation of, or to remove, biofilm-embedded microorganisms on the surface(s) of medical devices (claimed). They are used to coat or clean medical devices that are likely to become contaminated or have become contaminated with microorganisms such as Gram-positive bacteria ( Staphylococcus epidermidis), Gram-negative bacteria (Pseudomonas aeruginosa) and/or fungi (Candida albicans). They are used to coat or clean disposable or permanent catheters (central venous catheters, dialysis catheters, long-term tunneled or short-term central venous catheters, peripherally inserted central catheters, peripheral venous catheters, pulmonary artery Schwann-Ganz catheters, urinary catheters and peritoneal catheters), long-term urinary devices, tissue-bonding urinary devices, vascular grafts, vascular catheter ports, wound drain tubes, ventricular catheters, hydrocephalus shunts, heart valves, heart assist devices (e.g. left ventricular assist devices), pacemaker capsules, incontinence devices, penile implants, small or temporary joint replacements, urinary dilators, cannulae, elastomers, hydrogels, surgical instruments, dental instruments, tubings (intravenous tubes, breathing tubes, dental water lines, dental drain tubes, feeding tubes), fabrics, paper, indicator strips (paper or plastic), adhesives (hydrogel, hot-melt or solvent-based), bandages, orthopedic implants and any other medical devices used in the medical field such as those to be inserted or implanted into a human or other animal. They may also be used to clean surfaces of equipment in operating rooms, emergency rooms, hospital rooms, clinics and bathrooms.
Novelty: Compositions to prevent growth of, or to clean, biofilm-embedded microorganisms on surface(s) of medical devices e.g. catheters comprise biofilm-penetrating agent(s) e.g. N-acetylcysteine

Industry

Biomedical

Sub Category

Medical Composition

*Abstract

Biofilm is a defensive layer naturally formed by microorganisms and it prevents the penetration of antimicrobial agents to kill the embedded microorganisms. NIH has estimated that up to 80% of human infections are biofilm related. Biofilm was also found in approximately 60% to 80% chronic wounds, posing a great challenge to chronic wound management in high risk populations such as diabetic patients and patients with indwelling medical devices.Baylor College of Medicine is seeking individuals interested in commercializing a novel biofilm disruption technology for medical devices developed by Dr. Rabih Darouiche. The invention employs antimicrobial and mucolytic biofilm penetrating agents, such as N-acetylcysteine (NAC) and its derivatives, to substantially prevent and remove biofilm from the surface of medical devices, including but not limited to adhesives, bandages, fabrics and catheters. This technology provides a promising solution to facilitate wound healing and better management for medical device associated infections in a wide range of clinical applications.In one proof-of-concept study, Dr. Darouiche and colleagues conducted a pilot clinical trial using a NAC-containing catheter-lock solution for the treatment of hemodialysis catheter┬┐associated bacteremia. 83% of the patients were successfully treated and 86% treated catheters did not yield the original infecting pathogen on culture, demonstrating the efficacy of this technology in a real clinical setting. In addition, the NAC-containing catheter-lock solution did not impair the mechanical integrity or increase the propensity for fracture of hemodialysis catheters. At high concentrations, NAC possesses a broad-spectrum antimicrobial activity against a variety of gram-positive and gram-negative bacteria, including multi-resistant organisms.

Country/Region

USA