Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/50—Prostheses not implantable in the body
  • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/00051—Accessories for dressings
  • A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/00051—Accessories for dressings
  • A61F13/00085—Accessories for dressings having means for facilitating the application on the skin, e.g. single hand handling facilities
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/00987—Apparatus or processes for manufacturing non-adhesive dressings or bandages
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/01—Non-adhesive bandages or dressings
  • A61F13/01034—Non-adhesive bandages or dressings characterised by a property
  • A61F13/01038—Flexibility, stretchability or elasticity
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/02—Adhesive bandages or dressings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/02—Adhesive bandages or dressings
  • A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
  • A61F13/0286—Apparatus or processes for manufacturing adhesive dressings or bandages manufacturing of non adhesive dressings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
• • 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
  • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
• • 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
  • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
  • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
  • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
  • A61L15/26—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
• • 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
  • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
  • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
  • A61L15/42—Use of materials characterised by their function or physical properties
  • A61L15/44—Medicaments
• • 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
  • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
  • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
  • A61L15/42—Use of materials characterised by their function or physical properties
  • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F2013/00089—Wound bandages
  • A61F2013/00157—Wound bandages for burns or skin transplants
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F2013/00361—Plasters
  • A61F2013/00365—Plasters use
  • A61F2013/00519—Plasters use for treating burn
• • 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

• This invention relates to a novel wound dressing design.
• this invention relates to a wound dressing which incorporates a unique set of features ideally suited for use by first responders in a mass casualty thermal and/or radiological burn injury event.
• a particular embodiment of this invention may be economically mass-produced, has an long or
• indefinite shelf life requires no special storage conditions, is not temperature sensitive, can be supplied in rolls, can be easily applied by persons with little or no training, immediately restores skin barrier function, provides an antimicrobial effect, reduces pain, manages wound exudate, accommodates edema, is transparent so that wounds may be visualized (e.g.,. seen) without dressing removal, and will not complicate the wound condition when proper medical attention is delayed for significant periods of time.
• Some dressings aggressively adhere to the wound surface.
• conventional gauze integrates into the wound as healing occurs and eschar forms on the wound surface.
• Other types of dressings are designed to adhere to the surrounding intact tissue around the wound site, but not directly to the wound. Examples of this type of dressing include polyurethane films coated with acrylic pressure sensitive adhesive.
• Other types of dressings are designed to be
• substantially nonadherent examples include polyethylene oxide hydrogels, but also non- hydrogel materials such as that described in my U.S. Patent number 4,832,009, which is incorporated herein by reference.
• the latter example is a dressing made from an interpenetrating polymer network ("IPN") of polytetrafluoroethylene (“PTFE”) and silicone, and is presently marketed by Bio Med Sciences, Inc. of
• antimicrobials include various ionic forms of silver, drugs such as Polymyxin B Sulfate, Bacitracin Zinc, Neomycin, or combinations thereof. In each case the active
• ingredient is delivered to the wound and is depleted from the dressing over time.
• first and second degree wounds There are a wide variety of wound types .
• the terms “first,” “second” and “third” degree are often used to describe the extent of the injury, particularly for burn injuries.
• First degree wounds involve only the epidermis or outermost layer of skin.
• a mild to moderate sunburn is a good example; the surface of the skin is not breached, there is no bleeding and no chance of infection.
• a second degree, or partial thickness injury extends through the epidermis and into the dermis . As long as part of the dermis remains, the epidermis will regenerate and the wound will spontaneously heal if proper conditions are maintained. Failure to maintain proper conditions results in delayed healing and may even cause a partial thickness wound to convert to full thickness via infection and/or integration of the dressing into the wound.
• a full thickness, or third degree injury extends entirely through the dermis to the subdermal tissue. These wounds will not spontaneously heal because dermal tissue is missing and cannot generate and support epidermal tissue.
• a tissue transplant is required by harvesting intact skin from a donor site or the application of a biosynthetic skin substitute.
• a partial thickness autograft is taken so that a portion of the dermal layer is transplanted but a portion remains behind, thereby allowing both sites to heal.
• modern technology has provided several alternatives to reduce the need for donor tissue. Such products may provide a
• TransCyte® Advanced Biohealing, Westport, CT
• Biobrane® Smith & Nephew
• burn treatment is a highly specialized form of medical care, which is the reason why designated burn centers" exist all around the world.
• burn centers In the United States there are
• the countermeasure required to stabilize patients in such a scenario must be a wound dressing that is easily stockpiled, transported, and applied by people with little or no training. Furthermore, the dressing must not complicate the wound by allowing infection or wound adherence/integration to occur. The dressing must also accommodate often copious amounts of fluid or exudate produced by such wounds. Importantly, the dressing must also be elastic and flexible to
• the dressing would also be transparent and not require changes, i.e. a single application would suffice.
• a carefully designed silicone-PTFE IPN in conjunction with a silane-based antimicrobial surface treatment provides a wound dressing ideally suited for use in a mass casualty thermal and/or radiological burn injury scenario.
• a thin elastic film approximately 50 microns thick of silicone-PTFE IPN material supported by a paper carrier substrate was coated on one side with a tacky silicone formulation containing 5 percent by weight 3- methoxysilylpropydimethyloctadecyl ammonium chloride . The material was then passed through a tunnel style oven and cured. The roll of coated IPN on substrate was then passed through a die cutting apparatus to create small slits, or fenestrations, in the film.
• the film was then removed from the carrier substrate and cut to approximately 20 cm widths and rewound onto itself into rolls approximately 10 meters long.
• Figure 1 shows a cross-sectional view of a
• inventive dressing (40) constructed in accordance with the invention, having a layer (10) of an IPN material that is coated with a layer (20) of tacky silicone containing 3- methoxysilylpropydimethyloctadecyl ammonium chloride with fenestrations (30) cut in the dressing (40) at regular intervals .
• Figure 2 is a top plan view of the silicone-PTFE IPN dressing (40) shown in Fig. 1, showing the
• Figure 3 is a perspective view of the inventive dressing (40), constructed in accordance with the invention, wrapped onto a core (50) to form a roll (60) of the dressing (40) .
• Figure 4 is a perspective view of the dressing
• a wound dressing (40) comprises a 10 meter long sheet or layer (10) of a thin film of silicone-PTFE IPN material coated on one side with a coating (20) of a tacky silicone formulation containing 5 percent by weight 3-methoxysilylpropydimethyloctadecyl ammonium chloride.
• the wound dressing (40) is fenestrated with 2.5 mm slits (30) preferably separated by approximately 1.5 cm from each other, and the wound dressing (40) preferably is cut to be 20 cm wide, and preferably the wound dressing (40) is self-wound onto a plastic core (50) with the tacky coating (20) wrapped "in” against the core (50) .
• 3-methoxysilylpropydimethyloctadecyl ammonium chloride is particularly preferred because it readily bonds to a silicone-based substrate and it physically disrupts the cell membrane of the target organism (e.g., a germ) on contact. This means organisms, do not metabolize the active agent and become resistant.
• the dressing (40) itself becomes
• antimicrobial This is an important difference from other commercially available antimicrobial dressings based on silver or other compounds which are delivered to the wound and are therefore depleted and lose effectiveness over time.
• Silon ® dressing that is, a Bio Med Sciences, Inc. dressing made from an interpenetrating polymer network (“IPN") of polytetrafluoroethylene (“PTFE”) and silicone
• IPN interpenetrating polymer network
• PTFE polytetrafluoroethylene
• silicone 3- methoxysilylpropydimethyloctadecyl ammonium chloride materials
• precut sheets on a release liner may be used instead of rolls.
• silver or other antimicrobial compounds or combinations of such with 3- methoxysilylpropydimethyloctadecyl ammonium chloride for clinically therapeutic reasons.
• an antimicrobial agent may be incorporated into the non- wound contacting side of the dressing to reduce the overall bioburden of the site. By incorporating the antimicrobial agent into silicone-PTFE IPN material layer (10) microbes on the exterior surface of the wound site would be inhibited, thus improving the overall hygiene of the entire wound environment.
• the fenestration pattern itself may engineered to optimally accommodate edema by designing various cut-patterns to effect expansion
• a continuous sheet or layer (10), approximately 20 meters long and 40 cm. wide, of silicone-PTFE IPN was manufactured according to established methods using a paper carrier substrate.
• the sheet or layer (10) of silicone-PTFE IPN film measured approximately 50 microns in thickness.
• the sheet or layer (10) of silicone-PTFE IPN film was then passed through a knife- over-roll assembly and coated with approximately 30 grams per square meter (gsm) of a silicone elastomer (product code 7-9600 from Dow Corning Corporation of Midland, MI), mixed with 5 percent by weight of 3- methoxysilylpropydimethyloctadecyl ammonium chloride (product code HM4100 from BIOSAFE, Inc. of Pittsburgh, PA) to form a coating (20) of tacky silicone containing 3-methoxysilylpropydimethyloctadecyl ammonium chloride on the sheet or layer (10) of the silicone-PTFE IPN film.
• a silicone elastomer product code 7-9600 from Dow Corn
• the fenestrated dressing (40) was slit to 20 cm wide and rewound onto 2.5 cm diameter cores (50) in lengths of 10 meters with the coated side of the dressing (40) (that is, the side of the dressing (40) having the coating (20)) in contact with the plastic core (50) .
• fenestrations (30) are not provided to the dressing (40)
• the same manufacturing process set out above for manufacturing fenestrated wound dressing (40) may be used to manufacture non-fenestrated wound dressing (40), except that the step of using the rotary die cutting apparatus to cut fenestrations into the wound dressing (40) may be skipped.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Vascular Medicine (AREA)
• Heart & Thoracic Surgery (AREA)
• Biomedical Technology (AREA)
• Epidemiology (AREA)
• Materials Engineering (AREA)
• Hematology (AREA)
• Medicinal Chemistry (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Manufacturing & Machinery (AREA)
• Pharmacology & Pharmacy (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Oncology (AREA)
• Communicable Diseases (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Dermatology (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Materials For Medical Uses (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

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• 2013
  • 2013-07-09 US US13/937,784 patent/US20140018717A1/en not_active Abandoned
  • 2013-07-09 KR KR1020157003438A patent/KR102258069B1/ko active Active
  • 2013-07-09 WO PCT/US2013/049727 patent/WO2014011636A1/en not_active Ceased
  • 2013-07-09 CN CN201380046670.0A patent/CN104640520B/zh active Active
  • 2013-07-09 AU AU2013288698A patent/AU2013288698B2/en active Active
  • 2013-07-09 ES ES13817174.9T patent/ES2663679T3/es active Active
  • 2013-07-09 RU RU2015103948A patent/RU2655766C2/ru active
  • 2013-07-09 EP EP13817174.9A patent/EP2872074B1/en active Active
  • 2013-07-09 CA CA2917843A patent/CA2917843C/en active Active
  • 2013-07-09 JP JP2015521744A patent/JP6278477B2/ja active Active
• 2015
  • 2015-01-11 IL IL236643A patent/IL236643B/en active IP Right Grant

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