WO2008115548A3 - Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma - Google Patents

Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma Download PDF

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Publication number
WO2008115548A3
WO2008115548A3 PCT/US2008/003676 US2008003676W WO2008115548A3 WO 2008115548 A3 WO2008115548 A3 WO 2008115548A3 US 2008003676 W US2008003676 W US 2008003676W WO 2008115548 A3 WO2008115548 A3 WO 2008115548A3
Authority
WO
WIPO (PCT)
Prior art keywords
freeze
vessel
dried
storing
making
Prior art date
Application number
PCT/US2008/003676
Other languages
French (fr)
Other versions
WO2008115548A2 (en
Inventor
Simon J Mccarthy
William D Block
John W Morgan
Lisa A Buckley
Lance D Hopman
Clint B Pepper
Original Assignee
Hemcon Medical Technologies In
Simon J Mccarthy
William D Block
John W Morgan
Lisa A Buckley
Lance D Hopman
Clint B Pepper
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 Hemcon Medical Technologies In, Simon J Mccarthy, William D Block, John W Morgan, Lisa A Buckley, Lance D Hopman, Clint B Pepper filed Critical Hemcon Medical Technologies In
Priority to JP2009554578A priority Critical patent/JP2010522176A/en
Priority to AU2008229322A priority patent/AU2008229322A1/en
Priority to EP08727027A priority patent/EP2136830A2/en
Priority to CN200880016560A priority patent/CN101678070A/en
Priority to CA002680658A priority patent/CA2680658A1/en
Publication of WO2008115548A2 publication Critical patent/WO2008115548A2/en
Publication of WO2008115548A3 publication Critical patent/WO2008115548A3/en
Priority to IL201057A priority patent/IL201057A0/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/10—Furniture specially adapted for surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/10—Furniture specially adapted for surgical or diagnostic appliances or instruments
    • A61B50/13—Trolleys, e.g. carts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A61B90/96—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text using barcodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • 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
    • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2037—Separating means having valve means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/10—Bar codes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1061—Break-apart tubing connectors or couplings

Abstract

A vessel receives a liquid material, which is freeze-dried in situ within the vessel. A gas permeable material carried by the vessel provides gas transport for sublimation during drying. After freeze drying, an oxygen-free inert gas is introduced into the vessel through the gas permeable material, to occupy the interior of the vessel with the freeze-dried material. The gas permeable material is covered, to trap the oxygen- free inert gas within the vessel with the freeze- dried material. The freeze-dried material is stored in the entrapped oxygen- free inert gas within the vessel for a storage period. The vessel receives a reconstituting liquid for mixing with the freeze-dried material, and conveys the reconstituted freeze-dried material from the vessel for administration to an individual.
PCT/US2008/003676 2007-03-19 2008-03-19 Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma WO2008115548A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2009554578A JP2010522176A (en) 2007-03-19 2008-03-19 Apparatus and method for producing, storing, and administering lyophilized material, such as lyophilized plasma
AU2008229322A AU2008229322A1 (en) 2007-03-19 2008-03-19 Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma
EP08727027A EP2136830A2 (en) 2007-03-19 2008-03-19 Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma
CN200880016560A CN101678070A (en) 2007-03-19 2008-03-19 Be used to make, store and supply equipment and method such as the freeze-dried material of frozen dry blood plasma
CA002680658A CA2680658A1 (en) 2007-03-19 2008-03-19 Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma
IL201057A IL201057A0 (en) 2007-03-19 2009-09-21 Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11/725,352 2007-03-19
US11/725,352 US7776022B2 (en) 2007-03-19 2007-03-19 Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma
US11/881,493 US20080234653A1 (en) 2007-03-19 2007-07-27 Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma
US11/881,493 2007-07-27

Publications (2)

Publication Number Publication Date
WO2008115548A2 WO2008115548A2 (en) 2008-09-25
WO2008115548A3 true WO2008115548A3 (en) 2008-11-06

Family

ID=39766679

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/003676 WO2008115548A2 (en) 2007-03-19 2008-03-19 Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma

Country Status (9)

Country Link
US (3) US7776022B2 (en)
EP (1) EP2136830A2 (en)
JP (1) JP2010522176A (en)
KR (1) KR20100014733A (en)
CN (1) CN101678070A (en)
AU (1) AU2008229322A1 (en)
CA (1) CA2680658A1 (en)
IL (1) IL201057A0 (en)
WO (1) WO2008115548A2 (en)

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US20080234653A1 (en) 2008-09-25
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