EP0625894A4 - Pansement a gel aqueux pour plaie et conditionnement. - Google Patents

Pansement a gel aqueux pour plaie et conditionnement.

Info

Publication number
EP0625894A4
EP0625894A4 EP19920921920 EP92921920A EP0625894A4 EP 0625894 A4 EP0625894 A4 EP 0625894A4 EP 19920921920 EP19920921920 EP 19920921920 EP 92921920 A EP92921920 A EP 92921920A EP 0625894 A4 EP0625894 A4 EP 0625894A4
Authority
EP
European Patent Office
Prior art keywords
package
wound
water
dressing
hydrocolloid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP19920921920
Other languages
German (de)
English (en)
Other versions
EP0625894A1 (fr
Inventor
Corporation Lectec
Original Assignee
Lectec Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US07/914,751 external-priority patent/US5804213A/en
Application filed by Lectec Corp filed Critical Lectec Corp
Publication of EP0625894A4 publication Critical patent/EP0625894A4/fr
Publication of EP0625894A1 publication Critical patent/EP0625894A1/fr
Ceased legal-status Critical Current

Links

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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/0066—Medicaments; Biocides
    • 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
    • A61F13/00072—Packaging of 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01008—Non-adhesive bandages or dressings characterised by the material
    • 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
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0023—Polysaccharides
    • 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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/008—Hydrogels or hydrocolloids
    • 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
    • A61F2013/00544—Plasters form or structure
    • A61F2013/00621—Plasters form or structure cast
    • A61F2013/00625—Plasters form or structure cast in situ
    • 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
    • A61F2013/00544—Plasters form or structure
    • A61F2013/00621—Plasters form or structure cast
    • A61F2013/00638—Gel
    • 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
    • A61F2013/00544—Plasters form or structure
    • A61F2013/00642—Plasters form or structure soluble, e.g. in water
    • 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
    • A61F2013/00727—Plasters means for wound humidity control
    • A61F2013/00748—Plasters means for wound humidity control with hydrocolloids or superabsorbers
    • 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
    • A61F2013/00897—Plasters package for individual plaster
    • 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
    • A61F2013/00902—Plasters containing means
    • 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
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/114—Nitric oxide, i.e. NO
    • 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
    • A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
    • 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
    • A61L2300/23—Carbohydrates
    • A61L2300/236—Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
    • 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
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A61L2300/254—Enzymes, proenzymes
    • 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
    • A61L2300/402—Anaestetics, analgesics, e.g. lidocaine
    • 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
    • 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
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • 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
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents

Definitions

  • wounds such as wounds resulting from injury, surgical wounds or d ⁇ cubitus ulcers
  • Conventional bandages often do not provide optimum results.
  • treatment should include the removal of necrotic tissue and the establishment of an environment that enhances wound healing.
  • Special pressure-relieving or reducing measures should also be taken.
  • a moist dressing is often beneficial.
  • the present invention provides a sterile wound dressing and package which permits the dressing to be prepared from two shelf-stable components and which is initially fluid to facilitate application to the wound but which, after being applied, forms a stable, elastic gel in situ to protect the wound ana maintain a moist environment at the tissue surface.
  • the invention also provides a dressing that is shelf stable yet is easily and quickly prepared and applied by health care workers and requires no refrigeration.
  • the new dressing also holds its shape through a wide range of temperatures, i.e., it forms a solid that is temperature non- reversible, and can be removed from the wound bed as a solid plug.
  • Figure 1 is a perspective view illustrating one form of package used in accordance with the invention
  • Figure 1A is a semi-diagrammatic cross-sectional view taken on line 1A-1A of Figure 1 showing sterilisa ⁇ tion of the package;
  • Figure 2 is a view similar to Figure 1 of an optional, modified form of the package with a clip par ⁇ tially removed;
  • Figure 3 is a view of the package of Figure 1 on a smaller scale illustrating the mixing of its contents;
  • Figure 4 is similar to Figure 3 but shows the package being opened
  • Figure 5 illustrates the application of the dressing to a wound
  • Figure 6 illustrates the dressing after being applied to the wound
  • Figure 7 is a vertical cross-sectional view taken on line 7-7 of Figure 6 while the dressing is still fluid;
  • Figure 8 is a view similar to Figure 7 after the dressing has solidified to form a self-supporting gel
  • Figure 9 shows a modified form of package
  • Figure 10 is a greatly magnified diagrammatic ver- tical cross-sectional view of one form of the invention taken on line 10-10 of Figure 1.
  • the invention provides a prepackaged wound dressing comprising a natural or synthetic hydrocolloid in dry particulate form.
  • a source of a measured quantity of water is also provided.
  • a biologically active agent is provided. These constituents are mixed just before use to form a briefly pourable, water-based natural or synthetic water soluble or water swellable hydrocolloidal polymeric gel ' for dressing wounds. Just after mixing, the gel is initially sufficiently fluid to be poured or spread into a wound but after application it soon forms a moist, solid elastic protective body that contains the natural or synthetic polymeric hydrocolloid in a hydrated state.
  • the biologically active agent when present, is dispersed in the gel.
  • the separate liquid and solid components are preferably contained in separate compartments of the same sealed container for being mixed together just before use.
  • the liquid component water gives the dispersion a fluid consistency initially, allowing it to be poured or spread into or onto the wound and to be precisely applied in the exact quantity and to the precise location required. It is then that the disper ⁇ sion solidifies to form a solid but elastic and pliable, self-supporting moist dressing structure which holds the biologically active agent in contact with the wound.
  • Water can be provided as one component of the package or, if desired, any available source of water can be used provided it is maintained in a sterile con ⁇ dition when mixed with the dry hydrocolloid. However, to best assure that the entire composition is sterile prior to application and that the correct amount of water is used, it is preferred to provide the required water in either the same container as the solid ingre ⁇ washers or in a companion container which can be easily mixed with the solid constituents under sterile con ⁇ ditions.
  • the dressing becomes molded to the shape of the wound and contains a large quantity of moisture that - will maintain the wound in a moist condition.
  • both solid and liquid constituents are prepackaged in a container having at least two separate compartments.
  • the water is separate from the dry hydrocolloid polymer.
  • the invention faci ⁇ litates mixing of these constituents under sterile con ⁇ ditions while still enclosed in the same package " provided for shipping and storing the product. It is also preferred that a portion of the package be removed to enable the initially fluid gel, which is in a pourable condition, to be easily expelled onto the wound.
  • the hydration of the dry particulate hydro- colloid begins the moment the solid and liquid consti ⁇ tuents come i contact with each other, i.e., upon mixing.
  • the product, a dispersion is, however, liquid at this stage and therefore can be easily applied to cover or fill a wound of any shape.
  • the dressing occupies the void within a wound.
  • the lower surface of the dressing has the same contour as the wound itself, i.e., the wound serves as a mold for shaping the dressing which then begins to solidify into a solid but flexible, three-dimensional form.
  • the gel thus formed in the wound is also strong enough to allow for easy removal and to provide some cushioning for the wound bed, i.e., protecting the wound.
  • the dressing also absorbs exudate from the wound and supplies the biologi ⁇ cally active agent to the tissue.
  • the freshly mixed solid and liquid components will remain fluid and pourable for about 10 seconds to 3 minutes.
  • the temperature is elevated above room temperature, the composition tends to solidify more rapidly.
  • one composition of the present invention reaches 6 million centipois in about 25 minutes, whereas at 15 ⁇ >C it takes an hour, other factors that affect the length of time that the dispersion remains as a fluid and the ultimate strength of the gel include the chemical composition of the polymer and cross-linker, if any, as well as the concentration of each.
  • liquid dispersion have sufficient body or viscosity to allow the wound to be filled with little or no tendency to flow out of or away from the wound; i.e., it is preferred that the dressing is not watery enough to flow or drip from the wound.
  • gel herein refers to a solid or semi- solid, elastic, pliable substance formed by the solidi ⁇ fication of an aqueous colloidal dispersion.
  • fluid refers to a water-based hydrocolloidal com ⁇ position that has sufficient liquidity to be poured or spread onto a wound.
  • the chemical composition of the natural or synthetic hydrocolloidal polymer employed should be selected to form a gel spontaneously after hydration or, if desired, the hydrocolloid can be one requiring a cross-linking agent to induce or enhance solidification of the polymer.
  • the present invention encompasses both of these systems.
  • the unique wound dressing of the present invention is easy to ship and mix. It is also easy to apply and use. It is supple, elastic, pliable, soft, semi-solid and conforms naturally to the contours of the wound. The water in the dressing keeps the wound moist ' .
  • the dressing is non-irritating, has no odor and promotes healing. The dressing will remain in place after appli ⁇ cation but can be easily removed as a solid plug.
  • FIG. 1-7 and 10 Shown in Figures 1-7 and 10 is a container 10 or pouch formed from flexible sheet material including upper and lower superimposed sheets, in this case consisting of an upper sheet of a fibrous material, e.g., paper 12, an upper sheet of plastic film 14 and a lower sheet of plastic film 16.
  • the sheets 12-16 are sealed together at their edges, e.g., by means cf heat and pressure (a heat seal) to form a permanent peripheral fin seal 18 which extends around the entire container 10.
  • the paper sheet 12 is sealed to the plastic sheet 14 along a transverse heat seal line 20.
  • a rupturable seal 24 which includes a rup- turable bond 22 ( Figure 10) between sheets 14 and 16. Communication inside the container 10 on either side of the rupturable seal 24 is prevented by means of bond 22. In this way, two separate compartments are formed to prevent contact between a dry particulate pharmaceutical constituent 26 on one side of seal 24 and liquid consti ⁇ tuents 28 (water) on the other side.
  • water herein includes aqueous solutions as well as pure water.
  • the package 10 is shipped as shown in Figure 1 with the water 28 separated by seal 24 from the dry particulate pharmaceutical constituents 26, thereby providing excellent shelf-life for the dry ingredients 26 which at this stage are inactive.
  • the package containing liquid and solid consti ⁇ tuents 28, 26 is preferably sterilized.
  • the contents are sterilized as shown in Figure 1A.
  • the paper sheet 12 is porous but impervious to pathogenic organisms. Its porosity allows a sterilizing agent such as ethylene oxide gas to be introduced into the pouch 10 to the left of the barrier 24, e.g., through a gas applicator manifold 30. Exposure to ethylene oxide for a period of six hours has been found satisfactory.
  • the liquid constituents 28 to the right of the barrier 24 are sterilized by being exposed to ionizing radiation 32 from a gamma radiation source 34 of >_ 2.5 Mrad.
  • the paper sheet 12 can be 37.5-pound per ream porous, waterproof paper formed from polytetrafluoro- ethylene, e.g., Tyvek ® paper 1073B or 1059B (available from DuPont, Inc. of Wilmington, Delaware), and the plastic sheets 14, 16 can be a 5 mil laminate, e.g. of polyethylene, aluminum foil, polyethylene and Mylar ® as available from Technipaq Corporation of Chicago, Illinois.
  • One suitable plastic resinous film ( Figure 10) used for the sheets 14 and 16 comprises a five-layer laminate which is formed from the following materials listed from the outside proceeding inwardly: first, a 0.5 mil layer 15a of saran-coated polyester film, e.g., M-30 which is a product code number of the DuPont
  • the bond 22 should be composed of a frangible material with a controlled, i.e., reduced peel strength. While various frangible heat-sealing substan ⁇ ces can be used that are known to those skilled in the art, one preferred heat-sealing substance is an iono er comprising a zinc salt of an ethylene acrylic acid co ⁇ polymer known as Surlyn ® by E.I. duPont of Wilmington, Delaware. The entire five-layer laminate 14, 16 is also available from the Hargro Flexible Packaging Company of Exton, Pennsylvania as product code F 92-LT-1.
  • the rupturable seal 24 consists of a bond 22 wherein the frangible ionomer layer 15e on the inner surface of the sheets 14 and 16 is bonded to itself.
  • An ionomer coating 15e has been found to be surprisingly effective in forming two kinds of bonds: first, the bond at 18 which is very difficult to break and the second at bond 22 which, although durable and strong, will still rupture reliably when manual pressure is applied to the liquid 28 to the right of the bond 22.
  • bond 22 can be reliably ruptured at ambient temperature solely by the application of external manual pressure applied to the liquid 28 in the compartment at the right in the figures.
  • the permanent seal 18 that extends around the entire periphery of the package 10 and the seal 24 between sheets 12 and 14 can be formed with a suitable heat sealer by applying heat and pressure; for example, at 430°F for one second at a pressure of 60 to 80 psi.
  • the permanent seal 18 will typically have an average burst strength of about 4188 g/in at room temperature after one week of storage.
  • the rupturable seal 24 can be formed at a pressure of 60 psi applied for one-half second at 230°F. This will give the rupturable seal 24 a burst strength of about 450 grams/inch at room temperature after one week's storage. As a result, the seal 24 can be broken by applying manual pressure to the external walls of the fluid-containing compartment at the right of seal 24 at ambient temperature. This will cause the fluid to spurt through the bond 20 into the compartment at the left and become mixed with the dry constituents 26 to form a dispersion which can then immediately be expelled from the package and applied to the skin of a patient.
  • the fluid- containing compartment will have a moisture vapor transmission rate of about 0.024 grams/100in 2 /24hr at 73°F and 90% relative humidity.
  • the oxygen permeability of the same compartment is 0.1982 cc/100in 2 /24hr at 77°F and 100% relative humidity.
  • the end portion of the pack ⁇ age 10 above the indentations 36, 38 is removable.
  • the aqueous hydrocolloid dispersion is a liquid and preferably sufficiently fluid to allow it to be poured into the wound as shown in Figure 5.
  • the dry solid constituents 26 begin to hydrate the moment the solid and liquid contact each other. After mixing, the mixture will remain fluid and pourable for typically about 10 seconds to 3 minutes.
  • the hydrocolloid dispersion while it is fluid, it will typically have a viscosity of less than 6,000,000 cp (Brookfield) . It should at least be sufficiently fluid to allow it to be easily spread onto the wound, e.g., with a spatula. However, pouring is preferred.
  • the liquid hydrocolloid mixture 52 as it is poured from the package 10 into the wound 41, will form a three-dimensional body substan ⁇ tially filling the wound; in other words, having a lower surface which conforms exactly to the shape of the wound.
  • the hydrocolloid is in effect molded by the con- 5 tour of the wound.
  • the liquid hydrocolloid 52 solidifies to form a three-dimensional, self-supporting solid but elastic dressing body 54 with a substantially flat or slightly upwardly curved upper 10 surface 56 and a lower surface 58 which conforms to the lower surface of the wound 41.
  • gas pervious (12) and gas imper ⁇ vious (14, 16) materials in a single container has highly beneficial and unique properties, allowing a 15. liquid to be held on one side of the barrier 22, 24 and a dry ingredient on the other side but both can be effi ⁇ ciently sterilized while in the same package.
  • the package 10 provides for two kinds of steriliza ⁇ tion in a single package. This is accomplished by pro- 20 viding two distinct components; paper 12 and plastic 14, 16. This eliminates the need for filling the package under sterile conditions which can substantially compli ⁇ cate and increase the cost of assembling packages.
  • the invention provides the ability to mix two 5 separate sterile components just before use. A sterile dressing can thus be delivered to a wound whenever needed with no requirement for refrigeration.
  • the invention can be applied to all kinds of wounds, including .abrasions which are flat, but it is 0 particularly useful in filling a wound which has a cavity or uneven surface.
  • the unique wound dressing body 54 is easy to apply and use.
  • the dressing 54 is supple, pliable, soft, solid but elastic, and conforms exactly to the contours of the wound 41.
  • the moisture 5 in the dressing 54 facilitates healing.
  • the dressing is non-irritating, has little odor, and promotes healing.
  • the dressing 54 will remain in place after being applied to the wound 41, but it can be easily removed later when required. Besides maintaining the wound 41 in a moist condition, the dressing 54 will absorb exudate from the wound as well as evaporate moisture from its top surface.
  • the solid dressing 54 is also non-cytotoxic. Removal of the dressing as a solid plug which is then weighed provides a convenient method of monitoring progress of wound healing. Since it is elastic, the dressing provides a cushioning function for the wound.
  • Figure 9 illustrates a package that includes a flexible envelope 64 similar to the envelope 12 sealed along its edges as shown at 66, e.g.
  • a predetermined quantity of water is sealed in pouch 68 and is then sterilized, e.g., by gamma radiation as described above.
  • the pouch 68 and hydrocolloid particles 26 are then sealed in the enve ⁇ lope 64 which is preferably composed at least in part of a material such as Tyvek* which is permeable to a steri ⁇ lizing gas.
  • the envelope 64 is then exposed to a steri- lizing gas, in this case ethylene oxide as described above. The package is then ready for use.
  • the hydrocolloid polymer particles employed can be any suitable biocompatible natural or synthetic gel forming hydrocolloid which, when mixed with water, will form a solid temperature non-reversible elastic gel, i.e., flexible hydrogel with or without a cross-linking agent to assist in the formation of a nonfluid dressing. Both the hydrocolloid and the cross-linking agent must, of course, be nontoxic. When boric acid is used as a cross-linking agent, it provides a bacteriostatic effect. Moisture evaporates from the dressing 54, thereby minimizing dimensional changes resulting from wound exudate absorption. Evaporation also cools the gel, which provides a soothing effect for the patient.
  • the gel forming hydrocolloid polymer is a natural polysaccharide gum, it is preferred that the molecular weight be typically between about 50,000 and 500,000.
  • One preferred natural gum is guar gum in an amount between about 3% and 15% and preferably between 9% and 12%, the balance being water and trace quantities of cross-linker.
  • Another suitable polymer is locust bean gum. Both guar and locust bean gum are polygalacto- mannan gums.
  • the quantities of the several com ⁇ ponents used in the gel composition can be varied widely depending upon the properties employed, at least a suf ⁇ ficient amount of polymer should be provided to give the gel a solid consistency after being allowed to set in contact with the wound. Generally greater amounts of polymer and cross-linking agent provide a more solid dressing. Sufficient water should be present to provide the initial fluidity required for pouring or spreading
  • the composition onto the wound When a cross-linker is employed, only enough is needed to cause the polymer to solidify.
  • the cross-linking agent can be varied from about 0% to 8% by weight and preferably from about 0.1% to about 5.0% by weight, with the balance, e.g., about 80% to 95% by weight, being water. All quantities herein are expressed as percent by weight.
  • any suitable nontoxic cross-linking agent of a com- position can be used to form a chemical bond between the molecules of the polymer to gel the dispersion 52, forming a solid body.
  • cross-linking agents for locust bean gum, guar or chemically modified guar are galactose, organic titanate or boric acid.
  • the hydrocolloid is a polyglucomannan (e.g., Konjak ® )
  • borax can be used as a cross-linking agent.
  • xanthan gum a suitable cross-linker for xanthan gum is mannose. If locust bean gum is used as the principle hydrocolloid, lactose or a suitable oligosaccharide can be used.
  • cross-linked polymers loose water solubility as well as any ability to soften in response to temperature changes. Consequently, once solidified, the dressing is non-thermoplastic, i.e., it will not return to a liquid state by heating or cooling.
  • a cross-linking agent is used in the following examples, it is packaged with the water. However, if desired, it can be packaged with the dry ingredients.
  • any of the following biologically active substances can be included in the composition: m ⁇ dica- tions and disinfectants as well as wound healing enhan ⁇ cers, e.g., a vitamin preparation, blood coagulants for battlefield applications, antiseptic compounds, anti ⁇ biotic compounds, or a source of oxygen.
  • biologically active substances are astringents, anti- biotics, oxidants, proteolytic enzymes, collagen cross ⁇ link inhibitors such as natural or synthetic diamines, e.g., cysta ine or histadine, putrescine, spermidine, cadaverine, alpha, omega diamino polyethylene or polypropylene oxide (available as Jeffamine ® from Texaco Chemical, Houston, Texas) and the like, various growth factors, amino acids, macrophage stimulating factors, narcotic analgesics, anesthetics, and the like.
  • diamines e.g., cysta ine or histadine
  • putrescine spermidine
  • cadaverine alpha, omega diamino polyethylene or polypropylene oxide
  • various growth factors amino acids
  • macrophage stimulating factors e.g., narcotic analgesics, anesthetics, and the like.
  • the moisture containing hydrogel can also be molded into an implantable delivery device having the form of a rod, disc or other selected shape and implanted under the skin through an incision made for that purpose.
  • the gel is formed from a pharmaceu ⁇ tical grade hydrocolloid, such as a pharmaceutical grade guar gum which has the property of providing a low endo- toxin content.
  • One or more of the biologically active agents is incorporated into the liquid gel.
  • the freshly prepared liquid gel is poured into a mold to form the implantable delivery unit containing a biologically active agent.
  • the molded unit e.g., having a rod form, is then implanted through an incision beneath the skin where it serves as an errodable implanted delivery device for delivering the biologically active composition into the bloodstream of the animal or human patient.
  • Freeze dried state. Freeze drying of biologically active agents (lyophilization) is a common method of preserving many unstable biologically active molecules. Mixing the dried, e.g., freeze dried biologically active agent with liquid components just prior to use in accor- dance with the present invention will ensure the longest useful lifetime for the biologically active molecules and the resulting gel will hold the biologically active agent in contact with the tissue.
  • Borax 0.8 gel Borax 0.8 gel.
  • Borax 0.4 phase nice gel.
  • Borax 0.3 phase chunky
  • DHSC Very slow gel Dihydroxy aluminum formation from sodium carbonate liquid phase.
  • NaCl sodium carbonate liquid phase.
  • ⁇ Other samples are made in which galactose is replaced by galactose pentasaccharide or mannose tetrasaccharide. Another sample is made with a tetrasaccharide containing both mannose and galactose in equal quantities.
  • Borax 0.5 slimy gel.
  • Stiff gel not very elastic .
  • the symbol "D" indicates that the biologically active agent is in the dry consti ⁇ tuent and " " in the water.
  • a dressing is made as in Example #1 except that an antibiotic comprising 5 mg/g neomycin sulfate is added to the dry constituents to prevent and fight oppor ⁇ tunistic infections.
  • This medicament-containing dressing gel can be used for treating pathogenic wounds, stasis ulcers and chronic wounds.
  • a dressing is made as in Example #2 except that an antibiotic comprising 400 Units/g of bacitracin is added to the dry ingredients to prevent and fight opportunistic infections.
  • a dressing is made as in Example #3 except that 500 units/g of polymyxin B sulfate is included for preventing infections. D
  • a dressing is made as in Example #4 except that cxy tetracycline HCl is provided in the amount of 30 mg/g for infections.
  • a dressing is made as in Example #5 except that 2.5 mg/g of gra acidin is included as an antibiotic for preventing and fighting infections.
  • a wound dressing is prepared as in Example #6 except that a coagulant/astringent comprising alum in the amount of 75 mg/g is included to provide an emergency or battlefield dressing for reducing blood loss.
  • a wound dressing is prepared as in Example #7 except that witch hazel in the amount of 200 mg/g is used as an astringent to provide an emergency or battlefield dressing for reducing blood loss.
  • a wound dressing is prepared as in Example #8 with 2% to 10% in separate samples of povidone iodine is included in the composition as a disinfectant for treating pathogenic wounds, stasis ulcers and cnronic wounds.
  • a wound dressing is prepared as in Example #9 with ozone included in the amount of 50 mg/g as an oxygen base and a disinfectant for treating pathogenic wounds, stasis ulcers and chronic wounds. • D
  • a wound dressing composition is prepared as in Example #10 with hydrogen peroxide used in the amount of 50 mg/g as a disinfectant for pathogenic wounds, stasis ulcers and chronic wounds.
  • a wound dressing is prepared as in Example #11 con ⁇ taining a proteolytic enzyme comprising 20 units/g of collagenase to provide enzymatic debraidment of patho- genie wounds, stasis ulcers and chronic wounds.
  • a wound dressing is prepared as in Example #12 con ⁇ taining a proteolytic enzyme comprising 10 units/g of streptokinase to provide enzymatic debraidment of pathogenic wounds, stasis ulcers and chronic wounds.
  • a wound dressing is prepared as in Example #13 con ⁇ taining a proteolytic enzyme comprising 10 units/g of streptodornase to provide enzymatic debraidment.
  • a wound dressing is prepared as in Example #14 including a diamine for reducing collagen cross- linking comprising 5 mg/g of putrescine.
  • a wound dressing is prepared as in Example #15 including a pclyamine for reducing collagen cross- linking comprising 10 mg/g of spermidine.
  • a wound dressing is prepared as in Example #16 including a diamine for reducing collagen cross- linking comprising 15 mg/g of cadaverine.
  • a wound dressing is prepared as in Example #17 including a growth factor comprising 40 units/g of platelet-derived growth factor to enhance natural healing processes and stimulate growth. D
  • a wound dressing is prepared as in Example #18 including a growth factor comprising 10 units/g of fibroblast growth factor to stimlate growth. D
  • a wound dressing is prepared as in Example #19 including a growth factor comprising 10 units/g of epidermal growth factor to stimulate growth. D
  • a wound dressing is prepared as in Example #20 including a growth factor comprising 10 units/g of transforming growth factor to stimulate growth. D
  • a wound dressing is prepared as in Example #21 including an immuno stimulator comprising 15 mg/g of L-arginine to stimulate the inflammatory phase of wound healing.
  • D or W an immuno stimulator comprising 15 mg/g of L-arginine to stimulate the inflammatory phase of wound healing.
  • a wound dressing is prepared as in Example #22 including an immuno stimulator comprising 5 mg/g of nitric oxide to stimulate wound healing.
  • a wound dressing is prepared as in Example #23 including an immuno stimulator comprising 50 mg/g of quadrol to facilitate wound healing.
  • W an immuno stimulator comprising 50 mg/g of quadrol to facilitate wound healing.
  • a wound dressing is prepared as in Example #24 including an immunostimulator comprising 50 ⁇ g/g of muramyl dipeptide to enhance wound healing.
  • a wound dressing is prepared as in Example #25 including an immunostimulator comprising 10 ⁇ g/g of macrophage activating factor to facilitate wound healing.
  • a wound dressing is prepared as in Example #26 with 1 mg/g of hyaluronic acid added to facilitate healing of pathogenic wounds, stasis ulcers and chronic wounds.
  • D or W 1 mg/g of hyaluronic acid added to facilitate healing of pathogenic wounds, stasis ulcers and chronic wounds.
  • a wound dressing is prepared as in Example #36 with 20 mg/g of diamino polyethylene oxide (Jeffamine ® EDR-148) for reducing collagen cross-linking. D or W
  • a wound dressing is prepared as in Example #1 with 5 mg/g morphine sulfate added as an analgesic for treating trauma -wounds encountered in emergency or battlefield medicine.
  • a wound dressing is prepared as in Example #6 with 1 mg/g of fentanyl citrate as an analgesic trah- ⁇ uilizer for treating emergency or battlefield wounds.
  • a wound dressing is prepared as in Example #2 with 5 mg/g lidocaine hydrochloride as a local anestheti: for painful wounds. D or W
  • a wound dressing is prepared as in Example #7 with 10 mg/g of a 100:1 ratio of procaine hydrochloride and epinephrine as a local anesthetic which is also vasoconstrictive. This will lessen bleeding as well as aid in retention of the anesthetic to tne site of need.
  • D or W

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  • Materials Engineering (AREA)
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Abstract

L'invention concerne un gel polymère aqueux hydrocolloïdal naturel ou synthétique destiné à panser des plaies ou à une implantation sous la peau d'un patient, maintenant la plaie à l'état humide. On utilise dans le pansement pour plaie un polymère hydrocolloïde formant un gel sous forme particulaire sèche (26), une source d'eau (28) ou une solution aqueuse, et facultativement des médicaments ainsi que des agents de réticulation. Les composants sous forme solide sèche et sous forme liquide sont initialement séparés, et ils sont contenus typiquement dans des compartiments séparés d'un conditionnement ou d'une poche hermétique (10), mais ils sont mélangés ensemble dans le conditionnement après ouverture de la fermeture (20), avant utilisation. Ladite poche se compose d'une matière en feuille souple comme du papier et de plastique (12-16), et elle est scellée aux bords (18). Le mélange a une consistance suffisamment fluide pour permettre qu'on le verse ou qu'on le répande sur la plaie. Il commence à se solidifier pour former une structure de pansement autonome, solide mais souple.
EP92921920A 1991-10-09 1992-10-02 Pansement a gel aqueux pour plaie et conditionnement Ceased EP0625894A1 (fr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US77406491A 1991-10-09 1991-10-09
US91315192A 1992-07-14 1992-07-14
US913151 1992-07-14
US07/914,751 US5804213A (en) 1991-10-09 1992-07-15 Biologically active aqueous gel wound dressing
US914751 1992-07-15
PCT/US1992/008403 WO1993006802A1 (fr) 1991-10-09 1992-10-02 Pansement a gel aqueux pour plaie et conditionnement
US774064 2001-01-31

Publications (2)

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EP0625894A4 true EP0625894A4 (fr) 1994-09-01
EP0625894A1 EP0625894A1 (fr) 1994-11-30

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EP92921920A Ceased EP0625894A1 (fr) 1991-10-09 1992-10-02 Pansement a gel aqueux pour plaie et conditionnement

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EP (1) EP0625894A1 (fr)
JP (1) JPH07500035A (fr)
AU (1) AU663737B2 (fr)
CA (1) CA2120936A1 (fr)
FI (1) FI941627A (fr)
MX (1) MX9205848A (fr)
NO (1) NO941284L (fr)
WO (1) WO1993006802A1 (fr)

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IN2014DN08122A (fr) 2012-03-06 2015-05-01 Ferrosan Medical Devices As
BR112014030962A2 (pt) 2012-06-12 2017-06-27 Ferrosan Medical Devices As métodos para preparação e para reconstituição de uma composição seca adequada para uso em hemostase e cicatrização de feridas, e, kit hemostático
US20160120706A1 (en) 2013-03-15 2016-05-05 Smith & Nephew Plc Wound dressing sealant and use thereof
EP3010419B1 (fr) 2013-06-21 2020-05-20 Ferrosan Medical Devices A/S Composition sèche dilatée sous vide, et seringue pour la retenir
RU2678592C1 (ru) 2013-12-11 2019-01-30 Ферросан Медикал Дивайсиз А/С Сухая композиция, содержащая компонент, улучшающий экструзию
US11046818B2 (en) 2014-10-13 2021-06-29 Ferrosan Medical Devices A/S Dry composition for use in haemostasis and wound healing
RU2705905C2 (ru) 2014-12-24 2019-11-12 Ферросан Медикал Дивайсиз А/С Шприц для удерживания и смешивания первого и второго веществ
EP3316930B1 (fr) 2015-07-03 2019-07-31 Ferrosan Medical Devices A/S Seringue destinée à mélanger deux composants et à maintenir un vide dans une condition de stockage
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EP3790600B1 (fr) 2018-05-09 2023-12-27 Ferrosan Medical Devices A/S Procédé de préparation d'une composition hémostatique
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Also Published As

Publication number Publication date
NO941284L (no) 1994-06-08
WO1993006802A1 (fr) 1993-04-15
NO941284D0 (no) 1994-04-08
MX9205848A (es) 1993-05-01
FI941627A0 (fi) 1994-04-08
FI941627A (fi) 1994-06-08
AU663737B2 (en) 1995-10-19
EP0625894A1 (fr) 1994-11-30
JPH07500035A (ja) 1995-01-05
CA2120936A1 (fr) 1993-04-15
AU2785792A (en) 1993-05-03

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