Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
  • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
  • A61L29/16—Biologically active materials, e.g. therapeutic substances
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
  • A61L27/54—Biologically active materials, e.g. therapeutic substances
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
  • A61L31/16—Biologically active materials, e.g. therapeutic substances
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
  • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
  • A61L2300/202—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with halogen atoms, e.g. triclosan, povidone-iodine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
  • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
  • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

• the present invention relates to improvements in biomaterials including ceramics and polymeric materials for use in medical applications, particularly in the use of such polymeric materials in the manufacture of medical devices and prostheses
• the present invention also relates to the medical devices and prostheses per se comprising such biomaterials
• prosthetic devices available to modern medicine provide effective relief from a range of painful, crippling and life-threatening disorders. Some, such as, artificial heart valves and haemodialysis shunts, have become essential for the survival of many patients, others, such as, prosthetic joints, enable patients to regain the ability to perform important physical activities. Artificial devices have been successfully developed and incorporated into nearly all of the body systems and the numbers of patients receiving implants continues to increase. There is no doubt that prostheses have both prolonged and improved the quality of life for millions of individuals.
• a wide variety of organisms are capable of initiating these iatrogenic infections
• the proportions vary with the type of device and medical procedure, but include Enterobacter spp, Enterococcns spp, Escherichia coli, Klebsiella spp, Pseudomonas aentginosa, Staphylococcus spp, Candida albicans and others Often the organism may arise from the patients own body flora but may also result from the hospital environment or nursing procedures.
• Triclosan (generic name) is a well-known broad spectrum antimicrobial agent for topical applications in cosmetic applications and for general hygiene applications, such as the antimicrobial applications to inanimate substrates, such as textiles
• Triclosan (2,4,4 1 -trichloro-2 I -hydroxy diphenyl ether) has the molecular formula C ⁇ 2 H 7 CL 3 O 2 and is commercially available under the trade names Irgasan (Ciba-Geigy Limited) and Microban (Hoechst Celanese). Its physical properties, toxicology and compatibility with various chemicals used in the hygiene area are well documented. Its uses extend from additives to soaps, deodorants and toothpastes to incorporation in textile materials and yarns. It is incorporated into clothing to control the growth of microorganisms between launderings. Other common applications include animal beds, dental floss, shoe innersoles, furniture coverings and public transport seating, to name but a few.
• a biomaterial comprising an antimicrobial or therapeutically effective amount of Triclosan, when used in the manufacture of a medical device or prosthesis for internal or in vivo medical applications
• Triclosan is readily available commercially with a purity greater than 99% The compound exhibits marked anti-microbial properties across a wide range of bacteria or fungi, including most of those mentioned above as being causative agents of iatrogenic infections In its usage to date, Triclosan has not induced resistance in exposed organisms The product has been marketed for many years as an anti-microbial system for preserving cosmetics and industrial products, for oral care products such as toothpaste and or hand disinfectants Through these uses it has undergone extensive toxicological testing and been found to be safe at recommended concentrations Additionally, the chemical has good environmental properties, yet is stable to hydrolysis It is poorly soluble in water and highly soluble in may organic solvents
• Triclosan has not previously been considered to be therapeutic in nature According to the present invention it is proposed that, by appropriate application, the chemical can be used in therapeutic situations in conjunction with therapeutic devices and prostheses. According to the invention, various types of biomaterials, including ceramics and polymers, can be produced incorporating Triclosan that would have distinct advantages over currently available and used materials. This has the potential to provide significant socio-economic benefits to both individuals and communities through decreased likelihood of iatrogenic infections and consequent shorter periods of hospitalisation/treatment.
• Triclosan is incorporated into the biomaterial by addition of Triclosan during the mixing/polymerisation stage, whereby the Triclosan is colloidally and homogeneously suspended within the amorphous zone of the polymer or other biomaterial.
• the Triclosan is introduced into the interstitial spaces of the polymer or other biomaterial in such a way as to not effect the physical properties of the biomaterial. These spaces act as reservoir for the Triclosan from which sub-micron sized particles thereof migrate to the surface of the biomaterial on demand There they become a tightly bound durable part ofthe surface itself.
• the surface of the biomaterial can be engineered to retain antimicrobial and biocompatible for the life ofthe product, and provides continuous, inherent control of the growth of broad range of microorganisms, including gram-positive and gram-negative bacteria, as well as fungi, moulds, mildew and yeasts. Triclosan is also believed to exhibit some virus-inactivating properties which prevent virus replication.
• Triclosan penetrates and disrupts the metabolic function of thin-walled microorganisms, interrupting their ability to function, grow and reproduce. Normal human cells are thick- walled, and are therefore unaffected by Triclosan.
• the antimicrobial biomaterials according to the present invention comprise a therapeutically effective amount of Triclosan. The amount used is for the most part arbitrary, depending primarily on the requirements of the particular application and the cost versus effective use life.
• Triclosan is incorporated into the polymer or other biomaterial in the range of from about 0.5% to about 5% by weight of the biomaterial, depending on the use requirements, but this range may be varied as required
• the present invention is applicable to any polymeric material or other biomaterial used in medical applications for the manufacture of medical devices or prostheses, including but not limited to polyvinyl chloride (PVC), polyamides, polystyrene, teflon as well as metals and ceramics.
• PVC polyvinyl chloride
• the antimicrobial polymeric material can be utilised in. cast, extruded, injection moulded, rotary moulded or blow moulded products, or in products which are machined according to end use requirements
• the invention is also applicable to durable coatings of biomaterials, such as polymeric coatings, applied to metallic surfaces, as may be required for some prostheses.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Medicinal Chemistry (AREA)
• Chemical & Material Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Molecular Biology (AREA)
• Epidemiology (AREA)
• Engineering & Computer Science (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Surgery (AREA)
• Vascular Medicine (AREA)
• Dermatology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Materials For Medical Uses (AREA)

Applications Claiming Priority (3)

Publications (2)

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Family Applications (1)

Country Status (3)

Families Citing this family (17)

Citations (1)

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• 1995
  • 1995-10-13 AU AUPN5965A patent/AUPN596595A0/en not_active Abandoned
• 1996
  • 1996-10-14 WO PCT/AU1996/000642 patent/WO1997014447A1/en not_active Application Discontinuation
  • 1996-10-14 EP EP96933263A patent/EP0964706A4/de not_active Withdrawn

Patent Citations (1)

Non-Patent Citations (1)

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