DK2077867T3 - Blodposesystem og fremgangsmåde til inaktivering af patogener i blodpladekoncentrater ved anvendelse af blodposesystemet - Google Patents

Blodposesystem og fremgangsmåde til inaktivering af patogener i blodpladekoncentrater ved anvendelse af blodposesystemet Download PDF

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DK2077867T3
DK2077867T3 DK07726129.5T DK07726129T DK2077867T3 DK 2077867 T3 DK2077867 T3 DK 2077867T3 DK 07726129 T DK07726129 T DK 07726129T DK 2077867 T3 DK2077867 T3 DK 2077867T3
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bag
irradiation
blood
platelet
storage
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Wolfram Hubert Walker
Frank Tolksdorf
Thierry Verpoort
Francis Goudaliez
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Maco Pharma Sa
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • A61M1/0272Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/10Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person
    • A61K41/17Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person by ultraviolet [UV] or infrared [IR] light, X-rays or gamma rays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029Radiation
    • A61L2/0047Ultraviolet radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • A61M1/0209Multiple bag systems for separating or storing blood components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • A61M1/0209Multiple bag systems for separating or storing blood components
    • A61M1/0218Multiple bag systems for separating or storing blood components with filters
    • A61M1/0222Multiple bag systems for separating or storing blood components with filters and filter bypass
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • A61M1/0209Multiple bag systems for separating or storing blood components
    • A61M1/0231Multiple bag systems for separating or storing blood components with gas separating means, e.g. air outlet through microporous membrane or gas bag
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3681Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by irradiation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • B65B55/04Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/08Sterilising wrappers or receptacles prior to, or during, packaging by irradiation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • B65B55/12Sterilising contents prior to, or during, packaging
    • B65B55/16Sterilising contents prior to, or during, packaging by irradiation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00Closing containers or receptacles after filling
    • B65B7/02Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • A61J1/12Bag-type containers with means for holding samples of contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/22Blood or products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/23Containers, e.g. vials, bottles, syringes, mail
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/05General characteristics of the apparatus combined with other kinds of therapy
    • A61M2205/051General characteristics of the apparatus combined with other kinds of therapy with radiation therapy
    • A61M2205/053General characteristics of the apparatus combined with other kinds of therapy with radiation therapy ultraviolet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2207/00Methods of manufacture, assembly or production

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mechanical Engineering (AREA)
  • Molecular Biology (AREA)
  • Toxicology (AREA)
  • Cardiology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • External Artificial Organs (AREA)

Claims (19)

1. Blodposesystem omfattende et biologisk fluid såsom blodpladekoncentrat og yderligere omfattende: - en opbevaringspose (4) lavet af et plastmateriale, - en bestrålingspose (2) lavet af et fleksibelt plastmateriale, som er i det væsentlige gennemsigtigt for UV-stråling og har en volumenkapacitet på mindst 10 gange rumfanget af det biologiske fluid indeholdt i bestrålingsposen, og omfattende et eller flere indløbsrør (1) og/eller udløbsrør (3), og - opbevaringsposen (4) og bestrålingsposen (2) er en og samme pose eller mindst to forskellige, der kan forbindes med hinanden, - hvor bestrålingsposen (2) omfatter en forsegling (16, 17), der tilvejebringer et rum indeholdende det biologiske fluid, der skal behandles, og et separat rum adskilt derfra omfattende den/de indre ende/ender af de et eller flere indløbsrør (1) og/eller udløbsrør (3), hvilken forsegling (16, 17) er placeret ved et hjørne af bestrålingsposen (2) og tilvejebringer et afskæringshjørne, kendetegnet ved, at indersiden af bestrålingsposen (2) omfatter afskårne eller runde hjørner, og at forseglingen har form som et afrundet hjørne.
2. Blodposesystem ifølge krav 1, hvori indløbsrørene (1) og/eller udløbsrørene (3) omfatter mindst en afklemningsdel, prop (18) eller afbrækningsdel (15) som lukke for røret og forløbende ind i bestrålingsposen, fortrinsvis placeret ved rørets, især udløbsrørets (3), indvendige ende, i hvilket tilfælde lukket kan åbnes.
3. Blodposesystem ifølge krav 1 eller 2, hvori forseglingen er symmetrisk med mindst en anden kant, som derved tilvejebringer en symmetrisk bestrålingspose.
4. Blodposesystem ifølge ethvert af de foregående krav, hvori det separate rum kun omfatter et eller flere indløbsrør.
5. Blodposesystem ifølge ethvert af de foregående krav, kendetegnet ved, at det biologiske fluid indeholdt i bestrålingsposen ikke indeholder en fotosensibilisa-tor med et absorptionsmaksimum i området 200 til 270 nm, især 200 til 350 nm, og som fortrinsvis er frit for pafogeninaktiverende stof tilført det biologiske fluid og frit for fotosensibilisator.
6. Blodposesystem ifølge ethvert af de foregående krav, kendetegnet ved, at det biologiske fluid er opslemmet blodpladekoncentrat omfattende plasma, hvori mindst 20 vægt-% af plasmaet indeholdt i blodpladekoncentratet er byttet mod en blodpladeopbevaringsopløsning til dannelse af et opslemmet blodpladekoncen-trat, og at blodpladeopbevaringsopløsningen omfatter vand og opløselige salte.
7. Blodposesystem ifølge krav 6, kendetegnet ved, at blodpladeopbevaringsop-løsningen indeholder mindst et af følgende salte: citrat, fosfat og/eller acetat.
8. Blodposesystem ifølge ethvert af de foregående krav, kendetegnet ved, at det biologiske fluid omfatter 0,2 til 2,5 x 109 blodplader pr. ml biologisk fluid indeholdt i blodposesystem et.
9. Blodposesystem ifølge ethvert af de foregående krav, kendetegnet ved, at - bestrålingsposen (2) er forskellig fra opbevaringsposen (4), hvori opbevaringsposen (4) valgfrit har halvdelen eller mindre af volumenkapaciteten af bestrålingsposen (2), og - blodpladeposesystemet omfatter en rørføring (3) til indbyrdes at forbinde bestrålingsposen (2) og opbevaringsposen (4), og som eventuelt er aftagelig.
10. Blodposesystem ifølge ethvert af de foregående krav, hvori opbevaringsposen (4) er gennemtrængelig for mindst en gas valgt fra gruppen bestående af luft, ilt og kuldioxid.
11. Blodposesystem ifølge ethvert af de foregående krav, hvori bestrålingsposen (2) uafhængigt af hinanden er kendetegnet ved et eller flere indbyrdes uafhængige træk: a) bestrålingsposen (2) består af EVA, b) bestrålingsposen (2) er lavet af materiale, som ikke har noget absorptionsmaksimum i området fra 200 til 350 nm, fortrinsvis 250 til 300 nm, og c) bestrålingsposen (2) har en flad inderside, hvilken inderside har begrænsninger betragtet fra oven, der har mindst 4, fortrinsvis 6 eller 8 hjørner eller danner en cirkel eller oval, når den er fyldt med det biologiske fluid.
12. Blodposesystem ifølge ethvert af de foregående krav, yderligere omfattende et leukocytfilter (8).
13. Fremgangsmåde til inaktivering af patogener og reduktion af leukocytter i blodpladekoncentrater i et blodpladesystem ifølge ethvert af krav 1 til 12, omfattende følgende trin: - fremskaffelse af et blodpladekoncentrat fra menneskebloddonation ved aferese-teknikker eller ved ”buffy-coat pooling”-teknikker, - indføring af blodpladekoncentratet i bestrålingsposen (2), sådan at bestrålingsposen er mindre en 20 volumen-% fyldt, fortrinsvis fra 10 til 1 volumen-% fyldt, - bestråling af bestrålingsposen (2) omfattende blodpladekoncentratet med en bestrålingskilde omfattende UV-C-lys med en bølgelængde på 200 til 270 nm, mens bestrålingsposen holdes i bevægelse, - indføring af det bestrålede blodpladekoncentrat i opbevaringsposen (4) til opbevaring eller forbliven af det bestrålede blodpladekoncentrat i bestrålingsposen (2) for opbevaring i bestrålingsposen.
14. Fremgangsmåde ifølge krav 13, omfattende følgende yderligere trin: - bytning af mindst 20 vægt-%, fortrinsvis mindst 50 vægt-%, af plasmaet indeholdt i blodpladekoncentratet mod en blodpladeopbevaringsopløsning til dannelse af et opslemmet blodpladekoncentrat, hvilken blodpladeopbevaringsopløsning omfatter vand og et eller flere opløselige salte, før blodpladekoncentratet udsættes for UV-bestråling.
15. Fremgangsmåde ifølge krav 13, hvori fremgangsmåden er yderligere kendetegnet ved et eller flere indbyrdes uafhængige træk: a) bestrålingsposen (2) placeres på en stiv plade lavet valgfrit af glas/kvartsmateriale, mens den bestråles og bevæges, b) den fyldte bestrålingspose (2) har en gennemsnitlig tykkelse mindre end 5 mm, fortrinsvis mindre end 2,5 mm når den bestråles, c) bestrålingsposen (2) bevæges for at blande det flydende indhold homogent og/eller fremskaffe en fluidprofil med bølgelignende overfladeområder i bestrålingsposen (2), omfattende en flerhed af bevægende eller stående bølgedale og -kamme, hvori bølgedalene ved deres laveste punkt fortrinsvis har en lagtykkelse mindre en 2,5 mm, og d) hvori lysdosis til bestråling af bestrålingsposen er mellem 0,1 og 2 J/cm2.
16. Fremgangsmåde ifølge krav 13, hvori blodpladekoncentratet/det opslemmede blodpladekoncentrat opbevares a) ved stuetemperatur fortrinsvis i mindst 8 dage, eller b) ved stuetemperatur under let bevægelse, fortrinsvis mindst 8 dage.
17. Fremgangsmåde ifølge krav 13, hvori bestrålingsposen (2) bevæges under bestråling med en regelmæssig bevægelse med en amplitude fra 0,2 til 8 cm i planets x- og y-retninger, hvori x og y fortrinsvis er samme størrelse, og en frekvens af amplituden er fra 10 til 200 Hz.
18. Fremgangsmåde ifølge ethvert af krav 13 til 17, hvori bestrålingsposen (2) bestråles og bevæges, mens den er fladt udstrakt og vandret på en i det væsentlige plan plade uden fastspænding af bestrålingsposens (2) øverste lag, så det øverste lag tillades at bevæge sig frit som reaktion på posens bevægelse.
19. Fremgangsmåde til fremstilling af et blodpladesystem ifølge ethvert af krav 1 til 12, omfattende følgende trin: - tilvejebringelse af et bestrålingspose (2) lavet af et fleksibelt plastmateriale, som er i det væsentlige gennemsigtigt for UV-bestråling, og omfattende mindst et indløbsrør (1) placeret ved et hjørne af posen (2), - indføring af det biologiske fluid i bestrålingsposen (2) via indløbsrøret, så bestrålingsposen (2) er mindre end 20 volumen-% fyldt, - forsegling af posen, så der derved skabes et første forseglet rum, i hvilket indløbsrøret (1) udmunder, og en andet forseglet rum omfattende det biologiske fluid.
DK07726129.5T 2006-09-19 2007-06-22 Blodposesystem og fremgangsmåde til inaktivering af patogener i blodpladekoncentrater ved anvendelse af blodposesystemet DK2077867T3 (da)

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EP06019589A EP1902740A1 (en) 2006-09-19 2006-09-19 Blood bag system and process for the inactivation of pathogens in platelet concentrates by use of the blood bag system
PCT/EP2007/005538 WO2008034476A1 (en) 2006-09-19 2007-06-22 Blood bag system and process for the inactivation of pathogens in platelet concentrates by use of the blood bag system

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US (2) US20100133203A1 (da)
EP (2) EP1902740A1 (da)
JP (2) JP5868570B2 (da)
AU (1) AU2007299317B2 (da)
CA (1) CA2663443C (da)
DK (1) DK2077867T3 (da)
ES (1) ES2550638T3 (da)
PL (1) PL2077867T3 (da)
PT (1) PT2077867E (da)
WO (1) WO2008034476A1 (da)

Families Citing this family (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102005062410A1 (de) 2005-12-23 2007-08-09 Forschungsgemeinschaft Der Drk-Blutspendedienste E.V. Verfahren zur Bestrahlung von Thrombozytenkonzentraten in flexiblen Behältnissen mit ultraviolettem Licht
DE102005062634A1 (de) 2005-12-23 2007-06-28 Blutspendedienst der Landesverbände des Deutschen Roten Kreuzes Niedersachsen, Sachsen-Anhalt, Thüringen, Oldenburg und Bremen gGmbH Verfahren zur Inaktivierung von Pathogenen in Spenderblut, Blutplasma oder Erythrozytenkonzentraten in flexiblen Behältnissen unter Bewegung
EP1902740A1 (en) 2006-09-19 2008-03-26 Maco Pharma S.A. Blood bag system and process for the inactivation of pathogens in platelet concentrates by use of the blood bag system
EP2008669A1 (en) 2007-06-22 2008-12-31 Maco Pharma S.A. Irradiation apparatus for inactivating pathogens and/or leukocytes in a biological fluid and process
USD627527S1 (en) * 2008-07-08 2010-11-16 Radio Systems Corporation Pet bed heating pad
DE102008051123A1 (de) 2008-10-09 2010-04-15 Fresenius Kabi Deutschland Gmbh Beutel, Beutelset, Verfahren und Behandlungsvorrichtung zum Behandeln wenigstens einer Blutkomponente
DE102008053131A1 (de) 2008-10-24 2010-04-29 Fresenius Medical Care Deutschland Gmbh Verfahren und Anordnung zum Sterilisieren, insbesondere zum Sterilisieren eines Adsorbers
US12089589B2 (en) 2009-10-12 2024-09-17 Hemanext Inc. Irradiation of red blood cells and anaerobic storage
US11284616B2 (en) 2010-05-05 2022-03-29 Hemanext Inc. Irradiation of red blood cells and anaerobic storage
US9199016B2 (en) 2009-10-12 2015-12-01 New Health Sciences, Inc. System for extended storage of red blood cells and methods of use
US9005343B2 (en) 2010-05-05 2015-04-14 New Health Sciences, Inc. Integrated leukocyte, oxygen and/or CO2 depletion, and plasma separation filter device
DE102010030370A1 (de) * 2010-06-22 2011-12-22 Terumo Europe N.V. Kassette, Arbeitsstation und Verfahren zur Kennzeichnung von eine Flüssigkeit enthaltenden Behältern
JP5930483B2 (ja) 2010-08-25 2016-06-08 ニュー・ヘルス・サイエンシーズ・インコーポレイテッドNew Health Sciences, Inc. 保存中の赤血球の品質及び生存を高める方法
EP3539381B1 (en) * 2010-11-05 2023-05-24 Hemanext Inc. Irradiation of red blood cells and anaerobic storage
US8591486B2 (en) 2010-11-17 2013-11-26 Kci Licensing, Inc. Reduced-pressure systems and methods employing an ultraviolet light source for reducing bioburden
EP2685815A4 (en) 2011-03-16 2014-09-17 Mayo Foundation METHODS AND MATERIALS FOR EXTENDING USEFUL STORAGE OF PREPARATIONS OF HEMATIES AND PLATELET PREPARATIONS
US9067004B2 (en) 2011-03-28 2015-06-30 New Health Sciences, Inc. Method and system for removing oxygen and carbon dioxide during red cell blood processing using an inert carrier gas and manifold assembly
ITMI20120643A1 (it) * 2012-04-18 2013-10-19 Frattini Paolo Giuseppe Gobbi Sacca per soluzioni liquide miscelabili con sostanze attive disponibili in forma separata, in particolare in polvere o gel, per la formazione di sostanze medicinali o nutrizionali liquide somministrabili a pazienti per instillazione interna.
WO2014011499A1 (en) * 2012-07-12 2014-01-16 Terumo Bct, Inc. Hybrid blood component storage bag and method of making such bag
US20140127077A1 (en) * 2012-11-05 2014-05-08 Gail Rock Device and method for sterilization of instruments and surfaces
US9877476B2 (en) 2013-02-28 2018-01-30 New Health Sciences, Inc. Gas depletion and gas addition devices for blood treatment
US10376627B2 (en) 2014-03-24 2019-08-13 Fenwal, Inc. Flexible biological fluid filters
US10159778B2 (en) 2014-03-24 2018-12-25 Fenwal, Inc. Biological fluid filters having flexible walls and methods for making such filters
US9782707B2 (en) 2014-03-24 2017-10-10 Fenwal, Inc. Biological fluid filters having flexible walls and methods for making such filters
US9796166B2 (en) 2014-03-24 2017-10-24 Fenwal, Inc. Flexible biological fluid filters
US9968738B2 (en) 2014-03-24 2018-05-15 Fenwal, Inc. Biological fluid filters with molded frame and methods for making such filters
CN107530377B (zh) 2015-03-10 2021-09-03 新健康科学股份有限公司 氧减少一次性套件、装置及其使用方法
KR102661405B1 (ko) 2015-04-23 2024-04-25 헤마넥스트 인코포레이티드 혐기성 혈액 저장 용기
CN107735095B (zh) 2015-05-18 2022-06-14 希玛奈克斯特股份有限公司 储存全血的方法及其组合物
US10180248B2 (en) 2015-09-02 2019-01-15 ProPhotonix Limited LED lamp with sensing capabilities
US10730058B2 (en) * 2015-09-14 2020-08-04 Fenwal, Inc. Apparatus, systems and methods for storing, treating and/or processing blood and blood components
AU2017271545C1 (en) 2016-05-27 2023-06-15 Hemanext Inc. Anaerobic blood storage and pathogen inactivation method
CN106492245A (zh) * 2016-12-23 2017-03-15 中国人民解放军南京军区南京总医院 血液病原体灭活装置
FR3077824B1 (fr) * 2018-02-15 2022-01-14 Maco Pharma Sa Procede de preparation d'un lysat plaquettaire irradie
CN111544296B (zh) * 2020-06-18 2024-03-12 四川省人民医院 一种血液制品光能保藏袋
FR3112985B1 (fr) 2020-08-03 2023-11-17 Maco Pharma Sa Appareil pour souder une poche
CN113459593B (zh) * 2021-07-29 2022-11-22 山东中保康医疗器具有限公司 用于一次性去白细胞塑料血袋生产的充气方法
CN114084514B (zh) * 2021-11-24 2022-10-25 百林科制药装备科技(江苏)有限公司 一次性使用容器及其制备、检测方法
CN114366831A (zh) * 2022-01-10 2022-04-19 南京双威生物医学科技有限公司 一种基于核黄素光化学法的血浆病原体灭活处理方法
CN114366840B (zh) * 2022-01-12 2023-06-09 山东中保康医疗器具有限公司 基于血袋管理的病毒灭活装置
FR3133134A1 (fr) 2022-03-04 2023-09-08 Maco Pharma Système à poches pour le traitement par irradiation électromagnétique d’un fluide biologique
FR3133135A1 (fr) 2022-03-04 2023-09-08 Maco Pharma Système à poches pour le traitement par irradiation électromagnétique d’un fluide biologique
FR3138040A1 (fr) 2022-07-21 2024-01-26 Maco Pharma Appareil et procédé pour irradier un fluide biologique
USD1043970S1 (en) 2023-09-28 2024-09-24 Sai Yuvan Gudavalli IV bag

Family Cites Families (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US202395A (en) * 1878-04-16 Improvement in shaft-journals and boxes therefor
US178200A (en) * 1876-05-30 Improvement in grain separators
US164233A (en) * 1875-06-08 Improvement in roofing compositions
US155121A (en) * 1874-09-15 Improvement in shaft-couplings
US722676A (en) * 1901-01-04 1903-03-17 Peete B Clarke Compensating valve for hydraulic rams.
US4469227A (en) 1983-08-17 1984-09-04 Clifford Faust Package for cryogenically frozen liquids
US4586928A (en) * 1984-10-09 1986-05-06 Miles Laboratories, Inc. Pivoting frangible valve for plastic bags
US4630448A (en) * 1985-10-25 1986-12-23 Baxter Travenol Laboratories, Inc. Container for storing solid living tissue portions
US4952812A (en) * 1986-08-26 1990-08-28 Baxter International Inc. Irradiation of blood products
US4878891A (en) * 1987-06-25 1989-11-07 Baylor Research Foundation Method for eradicating infectious biological contaminants in body tissues
GB8807380D0 (en) 1988-03-29 1988-05-05 Gunn A Blood processing apparatus
US4952818A (en) * 1989-05-17 1990-08-28 International Business Machines Corporation Transmission line driver circuits
JP3182145B2 (ja) * 1990-04-16 2001-07-03 日本赤十字社 血小板保存液
JPH05131018A (ja) * 1991-11-11 1993-05-28 Terumo Corp バツグ連結体およびその製造方法
US6420570B1 (en) * 1993-06-28 2002-07-16 Cerus Corporation Psoralen compounds
US5556993A (en) * 1993-06-28 1996-09-17 Steritech, Inc. Compounds for the photodecontamination of pathogens in blood
ATE242960T1 (de) 1993-11-10 2003-07-15 Cerus Corp Vorrichtung und verfahren zur photoaktivierung
DE69637181T2 (de) 1995-07-14 2008-04-17 Caf - Dcf Cvba - Scrl Vorrichtung zur inaktivierung von viralen verunreinigungen in blutprodukten
JP3282952B2 (ja) * 1995-10-16 2002-05-20 テルモ株式会社 バッグ加圧装置
EP0874635B1 (en) * 1995-12-04 2003-03-19 Puget Sound Blood Center Nonimmunogenic platelet and red blood cell compositions
DE29801590U1 (de) 1998-01-30 1998-04-16 Maco Pharma Int Gmbh Blutbeutelsystem zur Virusinaktivierung von Blut, Blutkomponenten und Plasma
US6139878A (en) * 1998-04-27 2000-10-31 Aventis Behring, Llc Method for preparing a diafiltered stabilized blood product
EP1002512A3 (en) * 1998-11-19 2001-01-24 Bracco International B.V. Flexible container for the containment and delivery of fluids
US7445756B2 (en) * 1999-06-03 2008-11-04 Fenwal, Inc. Fluid processing sets and organizers for the same
US7025877B1 (en) * 1999-06-03 2006-04-11 Baxter International Inc. Processing set for processing and treating a biological fluid
US7094378B1 (en) 2000-06-15 2006-08-22 Gambro, Inc. Method and apparatus for inactivation of biological contaminants using photosensitizers
US6268120B1 (en) * 1999-10-19 2001-07-31 Gambro, Inc. Isoalloxazine derivatives to neutralize biological contaminants
US6596230B1 (en) 2000-01-28 2003-07-22 Baxter International Inc. Device and method for pathogen inactivation of therapeutic fluids with sterilizing radiation
US6576201B1 (en) 2000-01-28 2003-06-10 Baxter International Inc. Device and method for pathogen inactivation of therapeutic fluids with sterilizing radiation
WO2002026270A2 (en) 2000-09-27 2002-04-04 Gambro, Inc. Inactivation of contaminants using photosensitizers and pulsed light
US20020043051A1 (en) * 2000-10-17 2002-04-18 Gambro, Inc Container and method of sealing
US20020138066A1 (en) 2001-03-23 2002-09-26 Gambro, Inc. Multiple compartment bag with openable closure assembly
US20030127603A1 (en) 2001-05-15 2003-07-10 Bernard Horowitz Apparatus for the inactivation of pathogens in protein-containing fluids and uses thereof
US20030064001A1 (en) * 2001-05-17 2003-04-03 Fries William M. System for the decontamination of fluid products using light
US20030228564A1 (en) * 2001-05-30 2003-12-11 Edrich Richard Alan Nitric oxide in a pathogen inactivation process
WO2003026724A1 (en) 2001-09-27 2003-04-03 Gambro, Inc. Radio frequency or electromagnetic information systems and methods for use in extracorporeal blood processing
DE10152159A1 (de) 2001-10-25 2003-05-15 Aventis Behring Gmbh Verfahren zur proteinschonenden Reinigung von kontaminierten biologischen Flüssigkeiten
US7185087B2 (en) 2001-10-26 2007-02-27 Telefonaktiebolaget Lm Ericsson (Publ) Maintenance of third party service's subscription information
DE60327166D1 (de) * 2002-02-01 2009-05-28 Caridianbct Biotechnologies Ll Reduzierung von verunreinigungen in blut und blutprodukten durch verwendung von photoaktiven substanzen und bestrahlung mit licht eines engen wellelängenbereichs
JP2005524683A (ja) * 2002-04-12 2005-08-18 スロウレイ・テクノロジーズ・エルエルシー 流体を除染するための方法および装置
JP2005523746A (ja) 2002-04-26 2005-08-11 ガンブロ  インコーポレーテッド コンテナ内の流体を照射及び混合するための装置並びに方法
JP2004041711A (ja) * 2002-05-21 2004-02-12 Mariusu:Kk 血液保存バッグ
ATE340098T1 (de) 2003-03-17 2006-10-15 Oshkosh Truck Corp Drehbare und gelenkige materialhandhabungsvorrichtung
US7207964B2 (en) * 2003-03-17 2007-04-24 Hemavation, Llc Apparatus and method for down-regulating immune system mediators in blood
JP4272477B2 (ja) * 2003-08-08 2009-06-03 テルモ株式会社 血液成分採取装置
JP4473221B2 (ja) * 2004-01-16 2010-06-02 テルモ株式会社 包材および医療器具セット包装体
US8296071B2 (en) 2004-03-15 2012-10-23 Terumo Bct Biotechnologies, Llc Methods for uniformly treating biological samples with electromagnetic radiation
FR2887335B1 (fr) 2005-06-21 2007-08-10 Maco Pharma Sa Procede pour la determination d'une contamination pathogene dans un fluide contenant des plaquettes sanguines
DE102005062410A1 (de) 2005-12-23 2007-08-09 Forschungsgemeinschaft Der Drk-Blutspendedienste E.V. Verfahren zur Bestrahlung von Thrombozytenkonzentraten in flexiblen Behältnissen mit ultraviolettem Licht
DE102005062634A1 (de) 2005-12-23 2007-06-28 Blutspendedienst der Landesverbände des Deutschen Roten Kreuzes Niedersachsen, Sachsen-Anhalt, Thüringen, Oldenburg und Bremen gGmbH Verfahren zur Inaktivierung von Pathogenen in Spenderblut, Blutplasma oder Erythrozytenkonzentraten in flexiblen Behältnissen unter Bewegung
EP1902740A1 (en) 2006-09-19 2008-03-26 Maco Pharma S.A. Blood bag system and process for the inactivation of pathogens in platelet concentrates by use of the blood bag system
EP2008669A1 (en) 2007-06-22 2008-12-31 Maco Pharma S.A. Irradiation apparatus for inactivating pathogens and/or leukocytes in a biological fluid and process

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CA2663443A1 (en) 2008-03-27
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