[특허]Bag system for the cryopreservation of body fluids

Vita 34 AG

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특허 상세정보

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내보내기 페이스북 공유 트위터 공유 카카오톡 공유

Bag system for the cryopreservation of body fluids

특허상세정보
국가/구분	United States(US) Patent 등록
국제특허분류(IPC7판)	A61B-019/00
미국특허분류(USC)	422/045; 604/410; 604/408; 604/403
출원번호	UP-0473094 (2002-10-16)
등록번호	US-7618584 (2009-11-27)
우선권정보	DE-101 51 343(2001-10-22)
국제출원번호	PCT/EP02/011564 (2002-10-16)
§371/§102 date	20030925 (20030925)
국제공개번호	WO03/041634 (2003-05-22)
발명자 / 주소	Lampeter, Eberhard Egger, Dietmar
출원인 / 주소	Vita 34 AG
대리인 / 주소	McConathy, Evelyn H.
인용정보	피인용 횟수 : 5 인용 특허 : 14

초록
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The invention relates to a bag system for the cryopreservation of body fluids, that is blood, bone marrow or umbilical cord blood, the parts of the bag system being sterilized, and separable from one another, wherein liquids which permit and/or assist cryopreservation are located in the bag system and/or may be introduced into the bag system in a sterile form. The bag system, at least, comprising: a device for the direct removal of body fluid (1) from the living body, a region or number of regions for mixing the liquids with the body fluid and/or for storing the mixture of liquids and body fluid, a number of shut-off elements (2) and connecting lines (3) and an inlet element (4) and/or an outlet element (5). The bag system is characterized in that the parts of the bag system, which are connected in a communicating manner to one another by the connecting lines (3), form a closed, sterile system before the bag system is used, and the regions for storing the mixture of liquids and the body fluid are hermetically sealable and separable from one another.

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We claim: 1. A bag system for collection and cryopreservation of a quantity of body fluid and cells contained therein in a sterile, closed system having a plurality of parts, the system comprising: pre-connected device for directly and sterilely collecting body fluid and cells contained therein from a subject's body or blood vessel into the previously sterilized, closed system having a plurality of interconnected sterile parts, separably connected to one another within the closed system, capable of holding or receiving cryopreservation liquids in sterile form without damage to the system, wherein the plurality of parts comprise one or more regions; component for holding concentrated cryopreservation liquids in a protected area within the sterile closed system until addition of the cryopreservation liquid to the collected body fluid within the system; region for mixing the cryopreservation liquids and a volume of the collected body fluid and cells contained therein to form a mixture, the region having a closable vent for venting air therefrom within the closed system without opening the closed system, wherein the region is airtight when the vent is closed; a plurality of shut-off elements and connecting lines, wherein the connecting lines communicatingly connect parts of the bag system to one another within the closed, sterile system, wherein the regions for storing the liquids and the body fluid and mixtures thereof are hermetically sealable and separable from one another without breaching the closed system, and wherein the collected fluids and cells within the sterile, closed bag system are not exposed to outside contamination at any time during collection, processing or cryopreservation. 2. The bag system according to claim 1, wherein the regions for storing the mixture of liquids and the body fluid and cells contained therein comprise at least two chambers of a freezing bag. 3. The bag system according to claim 2, comprising a mixing bag within which is the region for mixing the liquids with the body fluid and cells contained therein, and the freezing bag within which is a region for storing the mixture of liquids and body fluid. 4. The bag system according to claim 3, wherein the freezing bag comprises one freezing chamber. 5. The bag system according to claim 3, wherein the freezing bag comprises at least two freezing chambers. 6. The bag system according to claim 3, comprising a connection between the mixing bag and the freezing bag by two or more connecting lines, at least one of which carries the mixture of liquids and fluids from the mixing bag to the freezing bag or chamber of the freezing bag, and a second line carries air from the mixture of liquids and fluids in the freezing bag or chamber, back to the emptied mixing bag. 7. The bag system according to claim 3, comprising a connection between the mixing bag and the freezing bag by one connecting line. 8. The bag system according to claim 3, configured for cryopreservation of blood, bone marrow, or umbilical cord blood. 9. The bag system according to claim 1, wherein the regions for storing the mixture of liquids and the body fluid and cells contained therein comprise at least two chambers of a mixing/freezing bag. 10. The bag system according to claim 1, wherein one or more regions for storing the mixture of liquids and body fluid and cells contained therein are formed in at least one of the connecting lines having a plurality of hermetically sealable and separable segments. 11. The bag system according to claim 1, further comprising a fill level indicator affixed to the region for mixing the liquids. 12. The bag system according to claim 1, wherein only the regions that are hermetically sealable and separable from one another for storing the mixture of liquids and body fluid and cells contained therein are configured for storing by cryopreservation. 13. The bag system according to claim 1, wherein the parts of the bag system are configured for only single-use. 14. The bag system according to claim 1, wherein the region for mixing the liquids with the body fluid and the region for storing the mixture of liquids and body fluid and cells contained therein comprise a mixing/freezing bag, and wherein the mixing/freezing bag further comprises a mixing/freezing chamber. 15. The bag system according to claim 1, wherein the region for mixing the liquids with the body fluid and the region for storing the mixture of liquids and body fluid and cells contained therein comprise a mixing/freezing bag, and wherein the mixing/freezing bag further comprises a mixing/freezing chamber and a freezing chamber. 16. A method of preparing body fluids and cells contained therein for long-term storage by cryopreservation in a closed, sterile transportation and storage system, the method comprising: providing a sterile transportation and storage system having parts pre-connected to one another in a liquid-communicating manner to form a the closed, sterile system; introducing body fluid and cells contained therein into the sterile transportation and storage system; holding concentrated cryopreservation liquids until needed in a protected area within the closed system where it will not damage the system; mixing variable volumes of the body fluid with cryopreservation liquids to form a mixture within the closed system, and venting air therefrom within the closed system as necessary to minimize bubbles while maintaining sterility of the mixture; transferring the mixture of cryopreservation liquids and body fluid into a region for storage within the closed transportation and storage system; and hermetically sealing and separating the region or the regions for storing the mixture of cryopreservation liquids and body fluid from the remainder of the closed system. 17. The method according to claim 16, further comprising processing body fluids and cells contained therein selected from the group consisting of blood, bone marrow, and umbilical cord blood. 18. The method according to claim 16, wherein the providing step comprises providing the transportation and storage system comprising a bag system for the cryopreservation of a quantity of body fluid and cells contained therein, wherein the system has a plurality of sterilized parts, separably connected to one another within the closed system, and capable of holding or receiving cryopreservation liquids in sterile form, wherein the plurality of parts comprise one or more regions within the closed system, and wherein the system comprises: sterile filtration means for directly removing body fluid and cells contained therein from a subject's body or blood vessel; a plurality of shut-off elements and connecting lines within the closed system, wherein the connecting lines communicatingly connect parts of the bag system to one another within the closed, sterile system, wherein the regions for storing the liquids and the body fluid and mixtures thereof are hermetically sealable and separable from one another without breaching the closed system. 19. The method according to claim 16, further comprising storing a total amount of liquid in the transportation and storage system in a number of partial amounts, hermetically separated from one another. 20. The method according to claim 16, further comprising carrying out all of the method steps as manual steps. 21. The method according to claim 16, further comprising transferring a defined amount of the mixture of cryopreservation liquids and body fluid into a region for storing. 22. The method of claim 16, further comprising: venting air from the mixture of liquids and fluids in the storage region via a connecting line; and then proceeding with the step of sealing and separating the line from the liquid/fluid filled storage region(s), thereby preventing reentry of the air into the storage region(s). 23. The method of claim 22, further comprising: returning air removed from the mixture of liquids and fluids in the storage region via a connecting line to an emptied region of the system and then proceeding with the step of sealing and separating the line from the liquid/fluid filled storage region(s), thereby preventing reentry of the air into the storage region(s). 24. The method of claim 16, further comprising: delivering a portion of the mixture of liquids and body fluids and cells contained therein into a connecting line of the closed system; then hermetically sealing and separating segments of the line, thereby dividing the mixture contained therein in aliquots ≦1 ml; and then cryopreserving and storing the segmented line together with, or separately from, the remainder of the liquid/fluid mixture, such that a single segment can be separated and the aliquot independently thawed without disturbing the remainder of the cryopreserved mixture.

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Bag system for the cryopreservation of body fluids

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Bag system for the cryopreservation of body fluids

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