WO2005016257A3 - Process of making flowable hemostatic compositions and devices containing such compositions - Google Patents

Process of making flowable hemostatic compositions and devices containing such compositions Download PDF

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Publication number
WO2005016257A3
WO2005016257A3 PCT/US2004/023779 US2004023779W WO2005016257A3 WO 2005016257 A3 WO2005016257 A3 WO 2005016257A3 US 2004023779 W US2004023779 W US 2004023779W WO 2005016257 A3 WO2005016257 A3 WO 2005016257A3
Authority
WO
WIPO (PCT)
Prior art keywords
compositions
flowable hemostatic
composition
solid particles
biocompatible
Prior art date
Application number
PCT/US2004/023779
Other languages
French (fr)
Other versions
WO2005016257A2 (en
Inventor
Sanyog M Pendharkar
Anne J Gorman
Guanghui Zhang
Ada Rivera
Dwayne Lee Looney
Original Assignee
Ethicon Inc
Sanyog M Pendharkar
Anne J Gorman
Guanghui Zhang
Ada Rivera
Dwayne Lee Looney
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34193165&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2005016257(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ethicon Inc, Sanyog M Pendharkar, Anne J Gorman, Guanghui Zhang, Ada Rivera, Dwayne Lee Looney filed Critical Ethicon Inc
Priority to JP2006522590A priority Critical patent/JP5089981B2/en
Priority to EP04757245.8A priority patent/EP1660042B1/en
Priority to AU2004264873A priority patent/AU2004264873B2/en
Priority to CA2534897A priority patent/CA2534897C/en
Priority to ES04757245.8T priority patent/ES2612131T3/en
Publication of WO2005016257A2 publication Critical patent/WO2005016257A2/en
Priority to US11/348,860 priority patent/US7833965B2/en
Publication of WO2005016257A3 publication Critical patent/WO2005016257A3/en
Priority to AU2009202172A priority patent/AU2009202172B8/en
Priority to US12/902,017 priority patent/US8551941B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/363—Fibrinogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4833—Thrombin (3.4.21.5)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • A61L24/104—Gelatin
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • A61L24/108—Specific proteins or polypeptides not covered by groups A61L24/102 - A61L24/106
    • 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
    • A61L26/0028—Polypeptides; Proteins; Degradation products 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
    • 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
    • A61L26/0028—Polypeptides; Proteins; Degradation products thereof
    • A61L26/0042—Fibrin; Fibrinogen
    • 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
    • A61L26/0095—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6429—Thrombin (3.4.21.5)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21005—Thrombin (3.4.21.5)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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

Abstract

The present invention is directed to processes of making flowable hemostatic compositions and devices that include the flowable hemostatic composition disposed therein, where a volume of biocompatible liquid, a volume of a biocompatible gas, and an amount of solid particles of a biocompatible polymer are mixed together to form a substantially homogenous composition including a discontinuous gas phase and the solid particles substantially homogenously dispersed throughout a continuous liquid phase to form a flowable hemostatic composition, and the composition then transferred into a device suitable for applying the flowable hemostatic composition to a site of a body requiring hemostasis under conditions effective to maintain the substantially homogenous dispersion of the gas phase and the solid particles throughout the liquid phase.
PCT/US2004/023779 2003-08-07 2004-07-23 Process of making flowable hemostatic compositions and devices containing such compositions WO2005016257A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
JP2006522590A JP5089981B2 (en) 2003-08-07 2004-07-23 Method for making flowable hemostatic compositions and devices containing these compositions
EP04757245.8A EP1660042B1 (en) 2003-08-07 2004-07-23 Process of making flowable hemostatic compositions and devices containing such compositions
AU2004264873A AU2004264873B2 (en) 2003-08-07 2004-07-23 Process of making flowable hemostatic compositions and devices containing such compositions
CA2534897A CA2534897C (en) 2003-08-07 2004-07-23 Process of making flowable hemostatic compositions and devices containing such compositions
ES04757245.8T ES2612131T3 (en) 2003-08-07 2004-07-23 Process for making hemostatic compositions and devices containing those compositions
US11/348,860 US7833965B2 (en) 2003-08-07 2006-02-07 Process of making flowable hemostatic compositions and devices containing such compositions
AU2009202172A AU2009202172B8 (en) 2003-08-07 2009-06-02 Process of making flowable hemostatic compositions and devices containing such compositions
US12/902,017 US8551941B2 (en) 2003-08-07 2010-10-11 Process of making flowable hemostatic compositions and devices containing such compositions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US49311603P 2003-08-07 2003-08-07
US60/493,116 2003-08-07

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US10/768,335 Continuation US20060019868A1 (en) 2003-08-07 2004-01-30 Hemostatic compositions and devices
US11/348,860 Continuation US7833965B2 (en) 2003-08-07 2006-02-07 Process of making flowable hemostatic compositions and devices containing such compositions

Publications (2)

Publication Number Publication Date
WO2005016257A2 WO2005016257A2 (en) 2005-02-24
WO2005016257A3 true WO2005016257A3 (en) 2006-02-23

Family

ID=34193165

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2004/023765 WO2005016256A2 (en) 2003-08-07 2004-07-23 Hemostatic compositions containing sterile thrombin
PCT/US2004/023779 WO2005016257A2 (en) 2003-08-07 2004-07-23 Process of making flowable hemostatic compositions and devices containing such compositions

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2004/023765 WO2005016256A2 (en) 2003-08-07 2004-07-23 Hemostatic compositions containing sterile thrombin

Country Status (7)

Country Link
US (4) US7927626B2 (en)
EP (2) EP1663297B2 (en)
JP (2) JP4823905B2 (en)
AU (3) AU2004264872B2 (en)
CA (2) CA2534895C (en)
ES (2) ES2625344T5 (en)
WO (2) WO2005016256A2 (en)

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US9005609B2 (en) 2003-08-07 2015-04-14 Ethicon, Inc. Hemostatic compositions containing sterile thrombin

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US9629798B2 (en) * 2008-04-03 2017-04-25 Mallinckrodt Pharma Ip Trading D.A.C. Hemostatic microspheres
JP5820807B2 (en) * 2009-05-28 2015-11-24 プロフィブリックス ビー．ヴイ． Fibrin sealant
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CA2801116C (en) 2010-06-01 2019-02-12 Baxter International Inc. Process for making dry and stable hemostatic compositions
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US10238598B2 (en) 2013-12-16 2019-03-26 The University Of British Columbia Self-fueled particles for propulsion through flowing aqueous fluids
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JP7395113B2 (en) 2018-05-09 2023-12-11 フェロサン メディカル デバイシーズ エイ／エス Method of preparing a hemostatic composition
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