Flexible multi-chamber container for the preparation of medical mixed solutions

• US 7,875,016 B2
• Filed: 06/16/2005
• Issued: 01/25/2011
• Est. Priority Date: 07/29/2004
• Status: Active Grant

• Current Assignee: Fresenius KABI Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius KABI Deutschland GmbH (Fresenius SE & Co. KGaA)
• Inventors: Brandenburger, Torsten, Wegner, Gerald, Engholm, Johan, O'Donnell, Manus, Pahlberg, Olof
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): SU, SUSAN SHAN
• Application Number:
  US11/658,899
• Publication Number:
  US 20080004594A1
• Time in Patent Office: 2,049 Days
• Field of Search: 604/409, 604/410, 604/416, 604/403, 604/408
• US Class Current: 604/410
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/2024 having peelable seals
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed

Abstract

A flexible multi-chamber container for preparation of medical mixed solutions includes at least three chambers separated from each other by leaktight seams. The chambers are designated to be filled with different solutions and are separated from each other by leaktight seams. At least a part of the first leaktight seam is provided with a separation zone to be opened for fluid transfer from the first chamber into the second chamber. At least a part of the second leaktight seam is provided with a separation zone to be opened for fluid transfer from the second chamber into the third chamber. The leaktight seams are arranged and the separation zones are formed such that, in use of the container for preparation of the medical mixed solution, the first separation and second separation zones are opened in a sequential order. The first zone is opened before the second separation zone is opened. Thus, the components are mixed one after another in a predetermined sequential order.

Claims

1. A flexible multi-chamber container for preparation of medical mixed solutions, comprising:

a first chamber configured to receive a first solution;

a second chamber configured to receive a second solution;

a third chamber configured to receive a third solution;

a first leaktight seam separating the first chamber from the second chamber;

a second leaktight seam separating the second chamber from the third chamber; and

a third leaktight seam separating the first chamber from the third chamber;

wherein at least a part of the first leaktight seam includes a first separation zone configured to open to allow for fluid transfer from the first chamber into the second chamber and at least a part of the second leaktight seam includes a second separation zone configured to open to allow for fluid transfer from the second chamber into the third chamber,

wherein, in preparation of the medical mixed solution, the first separation zone is configured to open before the second separation zone opens,

wherein the first leaktight seam includes horizontal and vertical portions, and the first separation zone is arranged in the vertical portion of the first leaktight seam,

wherein the first separation zone and the second separation zone are configured to open by exerting pressure on the container beginning from an upper portion of the first chamber down to a lower portion of the second and third chambers,

wherein the first chamber is L-shaped such that the first chamber is arranged in the upper portion and adjacent to both a horizontal side and a vertical side of the second chamber and adjacent to a horizontal side of the third chamber of the container.

2. The multi-chamber container according to claim 1, wherein the first separation zone and the second separation zone open by rolling up the container.

3. The multi-chamber container according to claim 1, wherein the first separation zone is a first peelable seal and the second separation zone is a second peelable seal.

4. The multi-chamber container according to claim 1, wherein the second leaktight seam extends substantially in a vertical direction.

5. The multi-chamber container according to claim 1, wherein the third leaktight seam extends substantially in a horizontal direction.

6. The multi-chamber container according to claim 1, wherein the first leaktight seam, second leaktight seam and third leaktight seam have a common upper end.

7. The multi-chamber container according to claim 1, wherein the first chamber is arranged in a right side portion of the container.

8. The multi-chamber container according to claim 1, wherein the second chamber is arranged in a middle portion of the container below the first chamber.

9. The multi-chamber container according to claim 1, wherein the third chamber is arranged in a left side portion of the container below the first chamber.

10. The multi-chamber container according to claim 1, wherein the first chamber has a larger volume than the second chamber or the third chamber, respectively.

11. The multi-chamber container according to claim 1, wherein the first chamber is filled with carbohydrates and/or electrolytes containing aqueous solution.

12. The multi-chamber container according to claim 1, wherein the second chamber is filled with amino acid containing aqueous solution.

13. The multi-chamber container according to claim 1, wherein the third chamber is filled with lipid emulsion.

14. The multi-chamber container according to claim 1, wherein the first chamber, the second chamber and the third chamber are provided with a port system for dispensing a medical mixed fluid made from a first liquid, a second liquid and a third liquid and/or for introducing supplementary agents.

15. The multi-chamber container according to claim 1, wherein the container comprises a polymeric film, the container including a first region forming an outside area and a second region forming a sealing inside area, the first region having a higher melting point than the second region, wherein the second region forming the sealing inside area is structured to form both permanent seals and peelable seals when subjected to different welding conditions.

16. The multi-chamber container according to claim 1, wherein the container comprises a polymeric film including at least two layers including an inside layer that is a sealant layer structured to form both permanent seals and peelable seals when subjected to welding at different temperatures.

17. The multi-chamber container according to claim 1, wherein the first separation zone is the entire first leaktight seam.

18. The multi-chamber container according to claim 1, wherein an inner sealant top layer and an inner sealant bottom layer are directly sealed together at the location of the leaktight seams.

19. The multi-chamber container according to claim 1, wherein exerting pressure comprises rolling the container.

20. The multi-chamber container according to claim 1, wherein the third leaktight seam is permanent.

21. A flexible multi-chamber container for preparation of medical mixed solutions, comprising:

a first chamber configured to receive a first solution;

a second chamber configured to receive a second solution;

a third chamber configured to receive a third solution;

a first leaktight seam separating the first chamber from the second chamber;

a second leaktight seam separating the second chamber from the third chamber; and

a third leaktight seam separating the first chamber from the third chamber;

wherein at least a part of the first leaktight seam includes a first peelable seal configured to open to allow for fluid transfer from the first chamber into the second chamber and at least a part of the second leaktight seam includes a second peelable seal configured to open to allow for fluid transfer from the second chamber into the third chamber, and

wherein at least one of the first peelable seal and the second peelable seal comprises a curved rupture zone extending from a first substantially straight section to a second substantially straight section, the rupture zone curving its entire length, and the first and second substantially straight sections being parallel to each other,

wherein the first chamber is L-shaped such that the first chamber is arranged in the upper portion and adjacent to both a horizontal side and a vertical side of the second chamber and adjacent to a horizontal side of the third chamber of the container.

22. The multi-chamber container according to claim 21, wherein the curved rupture zone forms an arc of a circle with a radius of 5 to 75 mm, wherein the radius extends from the center point of the circle to a point on an outer edge of the at least one of the first peelable seal and the second peelable seal.

23. The multi-chamber container according to claim 21, wherein the curved rupture zone is an arc of a circle with a radius of 10 to 30 mm.

24. The multi-chamber container according to claim 21, wherein the curved rupture zone is an arc of a circle with a radius of 20 to 25 mm.

25. The multi-chamber container according to claim 21, wherein the arc of the circle has a central angle of at least 60°

.

26. The multi-chamber container according to claim 21, wherein the arc of the circle has a central angle of 60°

to 180°

.

27. The multi-chamber container according to claim 21, wherein the curved rupture zone is S-shaped, having no straight or pointed portions.

28. The multi-chamber container according to claim 21, wherein the at least two substantially straight sections are offset laterally by a distance of about 5 to 75 mm.

29. The multi-chamber container according to claim 21, wherein the seal width of the at least two substantially straight sections and the rupture zone is from 2 to 10 mm.

30. A flexible multi-chamber container for preparation of medical mixed solutions, comprising:

a first chamber configured to receive a first solution;

a second chamber configured to receive a second solution;

a third chamber configured to receive a third solution;

a first leaktight seam separating the first chamber from the second chamber;

a second leaktight seam separating the second chamber from the third chamber; and

a third leaktight seam separating the first chamber from the third chamber;

wherein at least a part of the first leaktight seam includes a first separation zone configured to open to allow for fluid transfer from the first chamber into the second chamber and at least a part of the second leaktight seam includes a second separation zone configured to open to allow for fluid transfer from the second chamber into the third chamber,

wherein, in preparation of the medical mixed solution, the first separation zone is configured to open before the second separation zone opens, and

wherein the container is configured to allow the first solution, the second solution, and the third solution to be homogeneously mixed together,

wherein the first leaktight seam extends substantially in horizontal and vertical directions and is configured to open in both horizontal and vertical directions,

wherein the first separation zone and the second separation zone are configured to open by exerting pressure on the container beginning from an upper portion of the first chamber down to a lower portion of the second and third chambers,

wherein the first chamber is arranged in the upper portion and to the right side of the second and third chambers of the container, and a bottom portion of the container comprises a port.