WO2011127188A2 - Apparatuses, methods, and compositions for the treatment and prophylaxis of chronic wounds - Google Patents

Apparatuses, methods, and compositions for the treatment and prophylaxis of chronic wounds Download PDF

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Publication number
WO2011127188A2
WO2011127188A2 PCT/US2011/031441 US2011031441W WO2011127188A2 WO 2011127188 A2 WO2011127188 A2 WO 2011127188A2 US 2011031441 W US2011031441 W US 2011031441W WO 2011127188 A2 WO2011127188 A2 WO 2011127188A2
Authority
WO
WIPO (PCT)
Prior art keywords
biologically active
active composition
lipoic acid
wound dressing
wound
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
PCT/US2011/031441
Other languages
English (en)
French (fr)
Other versions
WO2011127188A3 (en
Inventor
Dmitry Zimnitsky
Jenny Finkbiner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
KCI Licensing Inc
Original Assignee
KCI Licensing Inc
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
Application filed by KCI Licensing Inc filed Critical KCI Licensing Inc
Priority to CA2790559A priority Critical patent/CA2790559A1/en
Priority to EP11715141.5A priority patent/EP2555805B1/en
Priority to JP2013503918A priority patent/JP5988309B2/ja
Priority to CN201180015381.5A priority patent/CN103402556B/zh
Priority to AU2011237638A priority patent/AU2011237638B2/en
Publication of WO2011127188A2 publication Critical patent/WO2011127188A2/en
Anticipated expiration legal-status Critical
Publication of WO2011127188A3 publication Critical patent/WO2011127188A3/en
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
    • 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
    • A61L15/425—Porous materials, e.g. foams or sponges
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61L2300/21—Acids
    • 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
    • A61L2300/432—Inhibitors, antagonists
    • A61L2300/434—Inhibitors, antagonists of enzymes
    • 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
    • A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures

Definitions

  • Typical procedures for treating chronic wounds include the use of absorbent dressings or hydrocolloid gels. Additionally, since most chronic wounds are infected, many wound dressings contain antimicrobial agents, such as silver or iodine, to either create a barrier to microorganisms or reduce microbial load. These treatments are used more for managing the wound environment and moisture balance than actively promoting wound healing.
  • FIG. 1 is a schematic, cross-sectional view of a reduced-pressure treatment system including wound dressing that utilizes a first distribution manifold according to one illustrative embodiment
  • the canister 104 may be a fluid reservoir, or collection member, to filter or hold exudates and other fluids removed from the tissue site 101.
  • the canister 104 and the reduced-pressure source 108 are integrated into a single housing structure.
  • the fluid supply 106 is fluidly connected to the reduced pressure dressing 110 by a third conduit 118 that may be connected directly to the reduced pressure dressing 110 (not shown) or indirectly via the first conduit 112 which requires valves 122 and 124 for controlling the delivery of reduced pressure from the reduced pressure source 108 and/or fluid 105 from the fluid supply 106, respectively.
  • the fluid 105 may be any gas or liquid, and may contain growth factors, healing factors, or other substances to treat the wound 102 at the tissue site 101.
  • the fluid 105 may be water, saline, or dye saline.
  • the reduced pressure dressing 110 includes a distribution manifold 130 adapted to be positioned at the tissue site 101, and a drape 132 that covers the distribution manifold 130 to maintain reduced pressure beneath the drape 132 at the tissue site 101.
  • the reduced pressure dressing 110 may also include a separate scaffold 140, wherein the scaffold is coated with a biologically active composition comprising a lipoic acid derivative, and is positioned within the wound 102 in fluid communication with the distribution manifold 130.
  • the system may further include a release layer 150 positioned in fluid communication between the distribution manifold 130 and the scaffold 140.
  • the release layer 150 may include a release material such as a hydro-gel foaming material or water-soluble polymer.
  • a tissue growth kit 911 for promoting new tissue growth at a tissue site includes a scaffold 913, a release material 915, and a distribution manifold 917.
  • the scaffold 913 includes a first and second side, the first side of the scaffold 913 being adapted to contact the tissue site.
  • the scaffold 913 is similar to the scaffold 140 described previously with reference to FIGs. 1-3.
  • the release material 915 is adapted to contact the second side of the scaffold 913 and is similar to the release layer 150 described previously with reference to FIGs. 1-3.
  • the distribution manifold 917 is adapted to contact the release material 915 to distribute a reduced pressure to the tissue site through the scaffold 913.
  • the reduced pressure dressing could also serve as an advanced tissue dressing alone in the absence of reduced pressure application.
  • the same materials, relative positioning, and connectivity between layers may be used in the advanced tissue dressing.
  • the advanced tissue dressing may include a first layer to promote and accept growth of new tissue, a third layer to assist in directing fluids away from the tissue site, and a second layer to facilitate removal of the third layer from the first layer at a selected time.
  • the third layer of the advanced tissue dressing instead of having a "manifold", may be considered to include a fluid reservoir for collecting and holding fluids exuded by the wound.
  • the materials described herein as being suitable distribution manifold materials are similarly suitable materials for the reservoir of the third layer. The only requirement of the reservoir is that the reservoir should be made from a material that is capable of storing fluids produced by or present at the tissue site.
  • lipoic acid molecules over other antioxidants include high antioxidant activity, the ability to scavenge free radicals in both water and fatty tissues, stability to gamma sterilization, and prolonged shelf-life, which is particularly important for medical device applications. Limited solubility in water and moderate hydrophobicity of alpha-lipoic acid are preferable for formulations that require graduate sustained release of antioxidants. These properties combined with low cost of derivatives such as alpha-lipoic acid make it a preferable solution for treatment of chronic wounds in general, and for incorporation into wound dressing such as the scaffold 140 of the wound dressing 1 10 described above.
  • a biologically active composition for use as described here further comprises a collagen, such as a hydrolyzed collagen (e.g., gelatin).
  • a collagen such as a hydrolyzed collagen (e.g., gelatin).
  • Gelatin can be processed from a variety of sources including, but not limited to, bovine skin, pig skin and bone material. Depending on the hydrolysis methods employed in manufacture, the gelatin may be defined as a type A or type B gelatin.
  • One advantage of using a gelatin rather than, or in addition to, collagen is that gelatin includes exposed peptide sequences that serve as signals for protease binding.
  • gelatin for use in biologically active compositions will, nonetheless, need to comprise sufficient gel strength to form an adherent layer on a porous material without causing the material to become overly stiff. Accordingly, gelatin for use in biologically active compositions can comprise a bloom value of between about 150-300 g, between about 200-250 g or about 225 g.
  • the scaffold 140 may be a polyurethane foam as described above that is coated with gelatin to provide the reduced pressure dressing 110 with a sacrificial substrate for MMPs.
  • Biologically active compositions may, for example, comprise 0.1% to 25%, 1% to 10% or about 6%, 8%, 10%, 15% or 20% w/w gelatin.
  • compositions disclosed herein may further comprise other biologically active molecules such as antimicrobial agents, growth factors, proteinase inhibitors, chelating agent or preservatives.
  • the composition additionally comprises a metal chelating agent capable of reducing MMP activity, such as EDTA.
  • Antimicrobial agents may also be used in compositions according to the invention.
  • the composition may include antibiotics, antifungal agents or more general antimicrobials.
  • Antimicrobial compounds compatible with lipoic acid formulation include, but are not limited to, non-ionic silver, polyhexamethylene biguanide, chlorhexidine, benzalconium chloride, triclosan and others.
  • the formulation of lipoic acid and gelatin applied as a coating on the open-cell reticulated polyurethane foam pads provides unique combination of effects and is highly effective for healing of chronic wounds.
  • the formulation can be used in combination with negative pressure wound therapy, which is known to be highly effective in stimulating growth of granulation tissue, reducing infection and maintaining proper moisture balance in the wound.
  • Addition gelatin and lipoic acid and EDTA to the dressing specifically addresses healing of chronic wounds removing barriers to normal healing such as abnormally high levels of ROS and MMPs.
  • a solution of sodium hydroxide can be added to the dipping solution described in Examples 1-2 to convert lipoic acid into sodium lipoate.
  • the pH of resulting solution should be in the range between 6 and 8.
  • the conversion of lipoic acid into sodium lipoate eliminates the risk of development of sulphur odor in the coated foams.
  • the systems and methods of the present invention have been described with reference to tissue growth and healing in human patients, it should be recognized that these systems and methods for applying reduced pressure tissue treatment can be used in any living organism in which it is desired to promote tissue growth or healing.
  • the systems and methods of the present invention may be applied to any tissue, including without limitation bone tissue, adipose tissue, muscle tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments.
  • the healing of tissue may be one focus of applying reduced pressure tissue treatment as described herein
  • the application of reduced pressure tissue treatment may also be used to generate tissue growth in tissues that are not diseased, defective, or damaged.
  • the harvested tissue may be transplanted to another tissue site to replace diseased or damaged tissue, or alternatively the harvested tissue may be transplanted to another patient.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Materials Engineering (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PCT/US2011/031441 2010-04-09 2011-04-06 Apparatuses, methods, and compositions for the treatment and prophylaxis of chronic wounds Ceased WO2011127188A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA2790559A CA2790559A1 (en) 2010-04-09 2011-04-06 Apparatuses, methods, and compositions for the treatment and prophylaxis of chronic wounds
EP11715141.5A EP2555805B1 (en) 2010-04-09 2011-04-06 Apparatuses, methods, and compositions for the treatment and prophylaxis of chronic wounds
JP2013503918A JP5988309B2 (ja) 2010-04-09 2011-04-06 慢性創傷を治療及び予防するための装置、方法、及び組成物
CN201180015381.5A CN103402556B (zh) 2010-04-09 2011-04-06 用于治疗和预防慢性伤口的装置、方法以及组合物
AU2011237638A AU2011237638B2 (en) 2010-04-09 2011-04-06 Apparatuses, methods, and compositions for the treatment and prophylaxis of chronic wounds

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/757,562 US8632512B2 (en) 2010-04-09 2010-04-09 Apparatuses, methods, and compositions for the treatment and prophylaxis of chronic wounds
US12/757,562 2010-04-09

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WO2011127188A2 true WO2011127188A2 (en) 2011-10-13
WO2011127188A3 WO2011127188A3 (en) 2015-09-17

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US (1) US8632512B2 (enExample)
EP (1) EP2555805B1 (enExample)
JP (2) JP5988309B2 (enExample)
CN (2) CN105126156A (enExample)
AU (1) AU2011237638B2 (enExample)
CA (1) CA2790559A1 (enExample)
TW (1) TW201141548A (enExample)
WO (1) WO2011127188A2 (enExample)

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