Containers and methods for storing and admixing medical solutions

• US 7,169,138 B2
• Filed: 11/09/2001
• Issued: 01/30/2007
• Est. Priority Date: 09/11/1996
• Status: Expired due to Fees

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Becker, Michael, Masterson, Michael, Desbrosses, Freddy
• Primary Examiner(s): Bianco; Patricia
• Application Number:
  US10/035,651
• Publication Number:
  US 20030036743A1
• Time in Patent Office: 1,908 Days
• Field of Search: 604/6.15, 604/401, 604/403, 604/410, 604/408, 604415-416, 604 87- 89, 604/409, 604/500, 604/518, 604/520, 604/522, 604/407, 604/257, 604/262, 206/219, 206/221, 206/222, 206/568, 220500-502, 220/506, 220/523, 220/526, 220/62.11, 220 6221- 6222, 534/67, 53473-480, 534/84, 535/62, 535/08, 383/35, 383/37, 383 38- 40, 383/42, 383/93, 383/94, 383/105, 383/109, 383/116, 383/127, 383/210, 383/211, 383/113, 383 78- 80, 383/88, 383/118, 128/DIG.24, 600/573, 600/575, 600/580
• 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
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: Y10S 977/713 including lipid layer

Abstract

Containers and methods for storing medical solutions are provided. More specifically, containers and methods for storing components that are to be admixed, together to create a final solution, one of the components comprising a lipid. In an embodiment, a container including an interior defining at least two chambers. The first chamber includes a lipid containing liquid. The second chamber includes a liquid that does not include a lipid. The first and second chambers are separated by an openable seal.

Claims

1. A container for storing, sterilizing, and admixing medical solutions comprising:

a first chamber;

a second chamber; and

a peelable seal separating the first chamber from the second chamber;

wherein the container leaches one or more of;

(i) less than 0.11 μ

g/ml of a semi-volatile compound;

(ii) less than 0.023 μ

g/ml of aluminum;

(iii) less than 5.6 μ

g/ml of an oligomeric propylene compound; and

(iv) less than 5.6 μ

g/ml of an oligomeric ethylene vinyl acetate compound;

into a lipid component contained and autoclaved in the container.

2. The container of claim 1 wherein the container is constructed from a flexible plastic material.

3. The container of claim 2 wherein the flexible plastic material does not contain polyvinyl chloride.

4. The container of claim 3 wherein the flexible plastic material is a multilayer film.

5. The container of claim 4 wherein the multilayer film comprises four layers.

6. The container of claim 1 wherein the peelable seal is a heat sealed peelable seal.

7. The container of claim 6 wherein the peelable seal is an RF welded peelable seal.

8. The container of claim 2 wherein the flexible plastic material further comprises an RF responsive polymer layer composed of an ethylene vinyl acetate copolymer.

9. The container of claim 1 wherein the semi-volatile compound is selected from the group consisting of 2,6 di-t-butyl-4-methyl-phenol;

2,6-di-t-butyl-4-ethylphenol; and

25-crown-5 ether.

10. The container of claim 9 wherein the container leaches less than 0.050 μ

g/ml of 2,6-di-t-butyl-4-methyl-phenol.

11. The container of claim 9 wherein the container leaches less than 0.010 μ

g/ml of 25-crown-5 ether.

12. The container of claim 9 wherein the container leaches less than 0.010 μ

g/ml of 2,6-di-t-butyl-4-ethylphenol.

13. A container and medical solution comprising:

a first chamber;

a second chamber;

a lipid component contained in one of the first and second chamber; and

a peelable seal separating the first chamber from the second chamber;

wherein the container leaches one or more of;

(i) less than 0.11 μ

g/ml of a semi-volatile compound;

(ii) less than 0.023 μ

g/ml of aluminum;

(iii) less than 5.6 μ

g/ml of an oligomeric propylene compound; and

(iv) less than 5.6 μ

g/ml of an oligomeric ethylene vinyl acetate compound, into the lipid component when autoclaved.

14. The container and medical solution of claim 13 wherein the container is constructed from a flexible plastic material.

15. The container and medical solution of claim 14 wherein the flexible plastic material does not contain polyvinyl chloride.

16. The container and medical solution of claim 15 wherein the flexible plastic material is a multilayer film.

17. The container and medical solution of claim 16 wherein the multilayer film comprises four layers.

18. The container and medical solution of claim 13 wherein the peelable seal is a heat sealed peelable seal.

19. The container and medical solution of claim 18 wherein the peelable seal is an RF welded peelable seal.

20. The container and medical solution of claim 13 wherein the flexible plastic material further comprises an RF responsive polymer layer composed of an ethylene vinyl acetate copolymer.

21. The container and medical solution of claim 13 wherein the semi-volatile compound is selected from the group consisting of 2,6 di-t-butyl-4-methyl-phenol;

2,6-di-t-butyl-4-ethylphenol; and

25-crown-5 ether.

22. The container and medical solution of claim 21 wherein the container leaches less than 0.050 μ

g/ml of 2,6-di-t-butyl-4-methyl-phenol.

23. The container and medical solution of claim 21 wherein the container leaches less than 0.010 μ

g/ml of 25-crown-5 ether.

24. The container and medical solution of claim 21 wherein the container leaches less than 0.011 μ

g/ml of 2,6-di-t-butyl-4-ethylphenol.

25. A medical product comprising:

a container having a first chamber;

a second chamber; and

a peelable seal separating the first chamber from the second chamber; and

a lipid component contained in one of the first and second chambers and having one or more of;

(i) a semi-volatile compound concentration of less than 0.11 μ

g/ml;

(ii) an aluminum concentration of less than 0.023 μ

g/ml;

(iii) an oligomeric propylene concentration of less than 5.6 μ

g/ml; and

(iv) an oligomeric ethylene vinyl acetate concentration of less than 5.6 μ

g/ml, after the container and lipid component contained in one of the first and second chamber have been autoclaved.

26. The medical product of claim 25 wherein the container is constructed from a flexible plastic material.

27. The medical product of claim 26 wherein the flexible plastic material does not contain polyvinyl chloride.

28. The medical product of claim 27 wherein the flexible plastic material is a multilayer film.

29. The medical product of claim 28 wherein the multilayer film comprises four layers.

30. The medical product of claim 25 wherein the peelable seal is a heat sealed peelable seal.

31. The medical product of claim 30 wherein the peelable seal is an RF welded peelable seal.

32. The medical product of claim 25 wherein the flexible plastic material further comprises an RF responsive polymer layer composed of an ethylene vinyl acetate copolymer.

33. The medical product of claim 25 wherein the semi-volatile compound is selected from the group consisting of 2,6 di-t-butyl-4-methyl-phenol;

2,6-di-t-butyl-4-ethylphenol; and

25-crown-5 ether.

34. The medical product of claim 33 wherein the concentration of 2,6-di-t-butyl-4-methyl-phenol is less than 0.050 μ

g/ml.

35. The medical product of claim 33 wherein the concentration of 25-crown-5 ether is less than 0.010 μ

g/ml.

36. The medical product of claim 33 wherein the concentration of 2,6-di-t-butyl-4-ethylphenol is less than 0.011 μ

g/ml.

37. An autoclaved medical product comprising:

a container having a peelable seal separating a first and second chamber; and

a lipid component contained in one of the first and second chambers, the lipid component including one or more of;

(i) less than 0.11 μ

g/ml of a semi-volatile compound;

(ii) less than 0.023 μ

g/ml of aluminum;

(iii) less than 5.6 μ

g/ml of an oligomeric propylene compound; and

(iv) less than 5.6 μ

g/ml of an oligomeric ethylene vinyl acetate compound.

38. The autoclaved medical product of claim 37 wherein the container is constructed from a flexible plastic material.

39. The autoclaved medical product of claim 38 wherein the flexible plastic material does not contain polyvinyl chloride.

40. The autoclaved medical product of claim 39 wherein the flexible plastic material is a multilayer film.

41. The autoclaved medical product of claim 40 wherein the multilayer film comprises four layers.

42. The autoclaved medical product of claim 37 wherein the peelable seal is a heat sealed peelable seal.

43. The autoclaved medical product of claim 42 wherein the peelable seal is an RF welded peelable seal.

44. The autoclaved medical product of claim 37 wherein the flexible plastic material further comprises an RF responsive polymer layer composed of an ethylene vinyl acetate copolymer.

45. The autoclaved medical product of claim 37 wherein the semi-volatile compound is selected from the group consisting of 2,6 di-t-butyl-4-methyl-phenol;

2,6-di-t-butyl-4-ethylphenol; and

25-crown-5 ether.

46. The autoclaved medical product of claim 45 wherein the concentration of 2,6-di-t-butyl-4-methyl-phenol is less than 0.050 μ

g/ml.

47. The autoclaved medical product of claim 45 wherein the concentration of 25-crown-5 ether is less than 0.010 μ

g/ml.

48. The autoclaved medical product of claim 45 wherein the concentration of 2,6-di-t-butyl-4-ethylphenol is less than 0.011 μ

g/ml.

49. A container for storing and admixing medical solution comprising:

a first chamber containing a lipid component having one or more of;

(i) less than 0.11 μ

g/ml of a semi-volatile compound;

(ii) less than 0.023 μ

g/ml of aluminum;

(iii) less than 5.6 μ

g/ml of an oligomeric propylene compound; and

(iv) less than 5.6 μ

g/ml of an oligomeric ethylene vinyl acetate compound;

a second chamber; and

a peelable seal separating the first chamber from the second chamber.

50. The container of claim 49 wherein the semi-volatile compound is selected from the group of 2,6 di-t-butyl-4-methyl-phenol;

2,6-di-t-butyl-4-ethylphenol; and

25-crown-5 ether.

51. The container of claim 50 wherein the predetermined concentration of 2,6-di-t-butyl-4-methyl-phenol is less than 0.050 μ

g/ml.

52. The container of claim 50 wherein the predetermined concentration of 2,6-di-t-butyl-4-ethylphenol is less than 0.011 μ

g/ml.

53. The container of claim 50 wherein the predetermined concentration of 25-crown-5 ether is less than 0.010 μ

g/ml.

54. The container of claim 49 wherein the lipid component includes less than 0.023 μ

g/ml of aluminum.

55. The container of claim 49 wherein the lipid component includes less than 5.6 μ

g/ml of an oligomeric propylene compound.

56. The container of claim 49 wherein the predetermined concentration is 5.6 μ

g/ml and the leached compound is oligomeric ethylene vinyl acetate.

57. The container of claim 49 wherein the container is constructed from a flexible plastic material.

58. The container of claim 57 wherein the flexible plastic material does not contain polyvinyl chloride.

59. The container of claim 58 wherein the flexible plastic material is a multilayer film.

60. The container of claim 59 wherein the multilayer film comprises four layers.

61. The container of claim 49 wherein the container is an autoclaved container.

62. The container of claim 49 wherein the peelable seal is a heat sealed peelable seal.

63. The container of claim 62 wherein the peelable seal is an RF welded peelable seal.

64. The container of claim 57 wherein the flexible plastic material further comprises an RF responsive polymer layer composed of an ethylene vinyl acetate copolymer.

65. The container of claim 64 wherein the lipid component includes less than 5.6 μ

g/ml of an oligomeric ethylene vinyl acetate compound.