Bag system for the cryopreservation of body fluids

• US 20040097862A1
• Filed: 09/25/2003
• Published: 05/20/2004
• Est. Priority Date: 10/22/2001
• Status: Active Grant

• Current Assignee: Vita 34 AG (Active Ownership Capital SARL)
• Original Assignee: Vita 34 AG (Active Ownership Capital SARL)
• Inventors: Lampeter, Eberhard, Egger, Dietmar
• Granted Patent: US 7,618,584 B2
• Time in Patent Office: Days
• US Class Current: 604/6.15
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0263 Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0231 with gas separating means, e.g. air outlet through microporous membrane or gas bag
• CPC Class Codes: A61M 1/0272 Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
• CPC Class Codes: A61M 2202/0462 Placental blood, umbilical cord blood
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid

Abstract

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, [sic] separable from one another and liquids which permit and/or assist cryopreservation being located in the bag system and/or able to be introduced into the bag system in a sterile form, 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.

Claims

1. 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, [sic] separable from one another and liquids which permit and/or assist cryopreservation being located in the bag system and/or able to be introduced into the bag system in a sterile form, 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),

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.

2. The bag system as claimed in claim 1, characterized in that the regions for storing the mixture of liquids and the body fluid are at least two chambers of a freezing bag (12) or of a mixing and freezing bag (16).

3. The bag system as claimed in claims 1 to [sic] 2, characterized in that a region for storing the mixture of liquids and the body fluid is a connecting line (3) which has a number of segments (6) which can be hermetically sealed and separated from one another.

4. The bag system as claimed in claims 1 to 3, characterized in that a filling level indication (7) is arranged at least in the respective region for mixing the liquids.

5. The bag system as claimed in claims 1 to 4, characterized in that only the regions which are hermetically sealable and separable from one another for storing the mixture of liquids and the body fluid are stored for cryopreservation.

6. The bag system as claimed in claims 1 to 5, characterized in that the regions which serve for storing the mixture of liquids and the body fluid, separated from the other parts of the system, are enclosed in an air-tight manner by an enclosure (8).

7. The bag system as claimed in claims 1 to 6, characterized in that the bag system and the parts of the bag system are intended for being used once.

8. The bag system as claimed in claims 1 to 7, characterized in that the region for mixing the liquids with the body fluid and the region for storing the mixture of liquids and body fluid are arranged in a mixing and freezing bag (16), the mixing and freezing bag (16) having a mixing and freezing chamber (9) or a mixing and freezing chamber (9) and a freezing chamber (10).

9. The bag system as claimed in claims 1 to 7, characterized in that the region for mixing the liquids with the body fluid is arranged in a mixing bag (11) and the region for storing the mixture of liquids and body fluid is arranged in a freezing bag (12), this bag having a freezing chamber (9) or two freezing chambers (9).

10. The bag system as claimed in claim 9, characterized in that the mixing bag (11) and the freezing bag (12) are connected to each other by two connecting lines (3).

11. The bag system as claimed in claim 9, characterized in that the mixing bag (11) and the freezing bag (12) are connected to each other by a connecting line (3).

13. The method as claimed in claim 12, characterized in that the transporting and storing system is a bag system according to claims 1 to 11.

15. The method as claimed in claim 13, characterized in that all the steps of the method can be carried out manually.

17. The method as claimed in claim 12, characterized in that the mixture of liquids which permit and/or assist the cryopreservation and the body fluid is transferred virtually without any bubbles into a region for storing. Claims 1-17 (canceled).

37. (new). The method according to claim 34, wherein the providing step comprises providing a bag system according to claim 1 forming a transportation and storage system.

12. A method of preparing body fluids, that is blood, bone marrow or umbilical cord blood, for long-term storage by cryopreservation in a transporting and storing system, at least comprising the steps of:

introducing the body fluid into the transporting and storing system,

providing or adding liquids which permit and/or assist the cryopreservation,

transferring the mixture of liquids which permit and/or assist the cryopreservation and the body fluid into a region for storage in the transporting and storing system,

characterized in that

the parts of the transporting and storing system which are connected in a liquid-communicating manner to one another form a closed, sterile system before the body fluid is introduced into the transporting and storing system and

the region or the regions for storing the mixture of liquids and the body fluid are hermetically sealable and separable from one another.

14. The method as claimed in claim 12 or 13, characterized in that the total amount of liquid which is located in the transporting and storing system is made up of a number of part-amounts, which are hermetically separate from one another and can be stored in this form.

16. The method as claimed in claim 12, characterized in that a defined amount of the mixture of liquids which permit and/or assist the cryopreservation and the body fluid is transferred into a region for storing.

18. (new). A bag system for body fluid cryopreservation, the system comprising:

a plurality of sterilized parts, separably connected to one another, and capable of holding or receiving cryopreservation liquids in sterile form;

a device for directly removing body fluid from a living body;

said plurality of parts being formed with one or more regions for at least one of mixing the liquids with the body fluid and storing a mixture of liquids and body fluid;

a plurality of shut-off elements and connecting lines;

an inlet element and/or an outlet element;

said connecting lines communicatingly connecting parts of the bag system to one another to form a closed, sterile system before the bag system is used; and

said regions for storing the mixture of liquids and body fluid being hermetically sealable and separable from one another.

19. (new). The bag system according to claim 18, wherein said regions for storing the mixture of liquids and the body fluid are defined by at least two chambers of a freezing bag.

20. (new). The bag system according to claim 18, wherein said regions for storing the mixture of liquids and the body fluid are defined by at least two chambers of a mixing and freezing bag.

21. (new). The bag system according to claim 18, wherein a respective said region for storing the mixture of liquids and body fluid is formed in a connecting line having a plurality of hermetically sealable and separable segments.

22. (new). The bag system according to claim 18, which comprises a fill level indication disposed at least in a respective said region for mixing the liquids.

23. (new). The bag system according to claim 18, wherein only the respective said regions that are hermetically sealable and separable from one another for storing the mixture of liquids and body fluid are configured for storing in cryopreservation.

24. (new). The bag system according to claim 18, which comprises an air-tight enclosure for enclosing the respective said regions for storing the mixture of liquids and body fluid, separated from other parts of the system.

25. (new). The bag system according to claim 18, wherein said parts of the bag system are single-use parts configured for a single use.

26. (new). The bag system according to claim 18, wherein said region for mixing the liquids with the body fluid and the region for storing the mixture of liquids and body fluid are formed in a mixing and freezing bag, said mixing and freezing bag being formed with a mixing and freezing chamber.

27. (new). The bag system according to claim 18, wherein said region for mixing the liquids with the body fluid and the region for storing the mixture of liquids and body fluid are formed in a mixing and freezing bag, said mixing and freezing bag being formed with a mixing and freezing chamber and with a freezing chamber.

28. (new). The bag system according to claim 18, which comprises a mixing bag having formed therein said region for mixing the liquids with the body fluid, and a freezing bag having formed therein said region for storing the mixture of liquids and body fluid.

29. (new). The bag system according to claim 28, wherein said freezing bag is formed with one freezing chamber.

30. (new). The bag system according to claim 28, wherein said freezing bag is formed with two freezing chambers.

31. (new). The bag system according to claim 28, wherein said mixing bag and said freezing bag are connected to each other by two connecting lines.

32. (new). The bag system according to claim 28, wherein said mixing bag and said freezing bag are connected to each other by a connecting line.

33. (new). The bag system according to claim 28 configured for cryopreservation of blood, bone marrow, or umbilical cord blood.

34. (new). A method of preparing body fluids for long-term storage by cryopreservation in a transportation and storage system, the method which comprises:

providing a transportation and storage system having parts connected to one another in a liquid-communicating manner to form a closed, sterile system;

introducing body fluid into the transportation and storage system;

mixing the body fluid with cryopreservation liquids to form a mixture;

transferring the mixture of cryopreservation liquids and body fluid into a region for storage in the transportation and storage system; and

hermetically sealing and separating the region or the regions for storing the mixture of cryopreservation liquids and body fluid.

35. (new). The method according to claim 34, which comprises processing body liquids selected from the group consisting of blood, bone marrow, and umbilical cord blood.

36. (new). The method according to claim 34, which comprises introducing or providing cryopreservation liquids that permit or assist in the cryopreservation of the body fluids.

38. (new). The method according to claim 34, which comprises storing a total amount of liquid in the transportation and storage system in a number of partial amounts, hermetically separate from one another.

39. (new). The method according to claim 34, which comprises carrying out all of the method steps as manual steps.

40. (new). The method according to claim 34, which comprises transferring a defined amount of the mixture of cryopreservation liquids and body fluid into a region for storing.

41. (new). The method according to claim 34, which comprises transferring the mixture of cryoconservation liquids and body fluid substantially in a bubble-free condition into a region for storing.