US20060088589A1 - Reinforced absorbable multilayered hemostatic wound dressing - Google Patents

Reinforced absorbable multilayered hemostatic wound dressing Download PDF

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Publication number
US20060088589A1
US20060088589A1 US11/252,175 US25217505A US2006088589A1 US 20060088589 A1 US20060088589 A1 US 20060088589A1 US 25217505 A US25217505 A US 25217505A US 2006088589 A1 US2006088589 A1 US 2006088589A1
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US
United States
Prior art keywords
absorbable
dressing
multilayered
multilayered dressing
nonwoven fabric
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.)
Abandoned
Application number
US11/252,175
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English (en)
Inventor
Anne Gorman
Sanyog Pendharkar
Guanghui Zhang
Lillian Bar
Israel Nur
Orgad Laub
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.)
Ethicon Inc
Omrix Biopharmaceuticals Inc
Original Assignee
OMRIX BIOPHARMACEUTICAL Inc
Ethicon 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 OMRIX BIOPHARMACEUTICAL Inc, Ethicon Inc filed Critical OMRIX BIOPHARMACEUTICAL Inc
Priority to US11/252,175 priority Critical patent/US20060088589A1/en
Assigned to OMRIX BIOPHARMACEUTICAL, INC. reassignment OMRIX BIOPHARMACEUTICAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BAR, LILLIAN, LAUB, ORGAD, NUR, ISRAEL
Priority to US11/400,849 priority patent/US9439997B2/en
Publication of US20060088589A1 publication Critical patent/US20060088589A1/en
Priority to US12/400,522 priority patent/US9358318B2/en
Priority to US13/747,189 priority patent/US20130136781A1/en
Assigned to ETHICON, INC. reassignment ETHICON, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GORMAN, ANNE JESSICA, ZHANG, GUANGHUI, PENDHARKAR, SANYOG MANOHAR
Assigned to OMRIX BIOPHARMACEUTICAL, INC. reassignment OMRIX BIOPHARMACEUTICAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BAR, LILLIAN, LAUB, ORGAD, NUR, ISRAEL
Abandoned legal-status Critical Current

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    • 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
    • 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
    • A61F13/01021—Non-adhesive bandages or dressings characterised by the structure of the dressing
    • A61F13/01029—Non-adhesive bandages or dressings characterised by the structure of the dressing made of multiple layers
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    • 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
    • A61L15/28—Polysaccharides or their derivatives
    • 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
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
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    • A61L15/42—Use of materials characterised by their function or physical properties
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61L15/64—Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the body
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    • B32B23/00—Layered products comprising a layer of cellulosic plastic substances, i.e. substances obtained by chemical modification of cellulose, e.g. cellulose ethers, cellulose esters, viscose
    • B32B23/02—Layered products comprising a layer of cellulosic plastic substances, i.e. substances obtained by chemical modification of cellulose, e.g. cellulose ethers, cellulose esters, viscose in the form of fibres or filaments
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    • B32B23/10—Layered products comprising a layer of cellulosic plastic substances, i.e. substances obtained by chemical modification of cellulose, e.g. cellulose ethers, cellulose esters, viscose next to a fibrous or filamentary layer
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    • B32B27/36—Layered products comprising a layer of synthetic resin comprising polyesters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/02—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by structural features of a fibrous or filamentary layer
    • B32B5/022—Non-woven fabric
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    • B32B5/00—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/02—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by structural features of a fibrous or filamentary layer
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/02—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by structural features of a fibrous or filamentary layer
    • B32B5/026—Knitted fabric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/22—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed
    • B32B5/24—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer
    • B32B5/26—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by the presence of two or more layers which are next to each other and are fibrous, filamentary, formed of particles or foamed one layer being a fibrous or filamentary layer another layer next to it also being fibrous or filamentary
    • 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
    • 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
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings
    • A61L2300/608—Coatings having two or more layers
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/04—Materials for stopping bleeding
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
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    • B32B2307/00—Properties of the layers or laminate
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/20—Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer
    • Y10T442/2525—Coating or impregnation functions biologically [e.g., insect repellent, antiseptic, insecticide, bactericide, etc.]

Definitions

  • the control of bleeding as well as sealing of air and various bodily fluids is essential and critical in surgical procedures to minimize blood loss, to seal tissue and organ structures, to reduce post-surgical complications, and to shorten the duration of the surgery in the operating room.
  • the FIGURE shows the pressure required to disrupt/burst the seal formed between the tissue and the hemostatic wound dressing.
  • the multilayered dressing is then dried at ambient room temperature and packaged in a suitable moisture barrier container.
  • the multilayered dressing having the thrombin and fibrinogen contains no more than 25% moisture, preferably no more than 15% moisture, and most preferably no more than 5% moisture.
  • the amount of thrombin and fibrinogen powder applied to the nonwoven fabric is sufficient to cover its surface such that no area is visibly devoid of coverage.
  • the powder may sit mostly on top of the nonwoven fabric or may penetrate into the nonwoven fabric as far as the surface of the second absorbable woven or knitted fabric. However, the bulk of the powder does not contact the second absorbable woven or knitted fabric, and no more than trace amounts of the powders penetrate to the underside of the second absorbable woven or knitted fabric.
  • Poly (glycolide-co-lactide) (PGL, 90/10 mol/mol) was melt-spun into fiber.
  • a 80 denier multifilament yarn was consolidated into a 800 denier consolidated yarn.
  • the consolidated yarn was crimped at approximately 110 degree C.
  • the crimped yarn was cut into staple having a length of about 1.25′′ in length.
  • 20 g of the crimped staple was accurately weighed and laid out uniformly on the feed conveyor belt of a multi-roller carding machine.
  • the environmental conditions (temp: 70 deg F./55% RH) were controlled.
  • the staple was then carded to create a nonwoven batt.
  • the batt was removed from the pick-up roller and cut into 4 equal parts.
  • BAC-2 [(Omrix Biopharmaceuticals, Inc.) specific activity (by Clauss) 0.3 g/g] and 1.89 g of thrombin were mixed thoroughly with about 420 ml of HFE7000.
  • the slurry was sprayed through a nozzle onto the multilayered fabric weighing about 12 g and sized to 8′′ ⁇ 12′′.
  • the multilayered hemostatic wound dressing was air dried for about 30 minutes. The environmental conditions were maintained at 75 degrees F./45% RH throughout the process.
  • the multilayered hemostatic wound dressing was cut into appropriate sizes and packed in a tray.
  • the tray is specifically designed such that the clearance between the top and the bottom of the tray is slightly less than the overall thickness of the dressing to ensure minimized motion of the dressing during shipping and handling.
  • the tray is further packaged in a foil pouch, which is thermally sealed with dessicants as needed.
  • the dressing was stored at 2-8 degrees C. until needed.
  • the “thickness” of the multilayered fabric/dresssing was measured as described herein.
  • the measurement tools were:

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Textile Engineering (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Laminated Bodies (AREA)
  • Treatments For Attaching Organic Compounds To Fibrous Goods (AREA)
US11/252,175 2004-10-20 2005-10-17 Reinforced absorbable multilayered hemostatic wound dressing Abandoned US20060088589A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US11/252,175 US20060088589A1 (en) 2004-10-20 2005-10-17 Reinforced absorbable multilayered hemostatic wound dressing
US11/400,849 US9439997B2 (en) 2004-10-20 2006-04-10 Reinforced absorbable multilayered hemostatis wound dressing
US12/400,522 US9358318B2 (en) 2004-10-20 2009-03-09 Method of making a reinforced absorbable multilayered hemostatic wound dressing
US13/747,189 US20130136781A1 (en) 2005-10-17 2013-01-22 Reinforced absorbable multilayered hemostatic wound dressing

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US62053904P 2004-10-20 2004-10-20
US69625805P 2005-07-01 2005-07-01
US11/252,175 US20060088589A1 (en) 2004-10-20 2005-10-17 Reinforced absorbable multilayered hemostatic wound dressing

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/400,849 Continuation-In-Part US9439997B2 (en) 2004-10-20 2006-04-10 Reinforced absorbable multilayered hemostatis wound dressing

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US20060088589A1 true US20060088589A1 (en) 2006-04-27

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Family Applications (4)

Application Number Title Priority Date Filing Date
US11/577,207 Abandoned US20080260810A1 (en) 2004-10-20 2005-10-17 Hemostat
US11/252,175 Abandoned US20060088589A1 (en) 2004-10-20 2005-10-17 Reinforced absorbable multilayered hemostatic wound dressing
US11/252,121 Abandoned US20060093655A1 (en) 2004-10-20 2005-10-17 Method for making a reinforced absorbable multilayered hemostatic wound dressing
US11/400,849 Active 2030-04-08 US9439997B2 (en) 2004-10-20 2006-04-10 Reinforced absorbable multilayered hemostatis wound dressing

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US11/577,207 Abandoned US20080260810A1 (en) 2004-10-20 2005-10-17 Hemostat

Family Applications After (2)

Application Number Title Priority Date Filing Date
US11/252,121 Abandoned US20060093655A1 (en) 2004-10-20 2005-10-17 Method for making a reinforced absorbable multilayered hemostatic wound dressing
US11/400,849 Active 2030-04-08 US9439997B2 (en) 2004-10-20 2006-04-10 Reinforced absorbable multilayered hemostatis wound dressing

Country Status (16)

Country Link
US (4) US20080260810A1 (da)
EP (4) EP1809343B1 (da)
JP (2) JP5133061B2 (da)
KR (2) KR20070095870A (da)
CN (1) CN102091347A (da)
AU (2) AU2005295365B2 (da)
BR (2) BRPI0516761B8 (da)
CA (2) CA2584698C (da)
DK (3) DK1809343T3 (da)
ES (3) ES2552233T3 (da)
FR (1) FR14C0026I1 (da)
HK (2) HK1130704A1 (da)
IL (2) IL182565A (da)
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