Storage package and a method for packaging

• US 6,848,574 B1
• Filed: 02/14/2000
• Issued: 02/01/2005
• Est. Priority Date: 02/12/1999
• Status: Expired due to Term

• Current Assignee: Astra Tech AB
• Original Assignee: Astra Tech AB
• Inventors: Israelsson, Anette, Pettersson, Agneta, Utas, Jan
• Primary Examiner(s): Bui, Luan K.
• Application Number:
  US09/913,241
• Time in Patent Office: 1,814 Days
• Field of Search: 206/205, 206/207, 206/210, 206/363, 206/364, 206/365, 206/438, 206/440
• US Class Current: 206/210
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: B65D 75/32 one or both sheets or blanks being recessed to accommodate contents
• CPC Class Codes: B65D 85/24 for needles, nails or like elongate small articles

Abstract

A storage package (1) contains a medical device (7) having a coated surface (8 ) which exhibits a reduced friction when wetted with a wetting liquid and a supply of the wetting liquid (9). The package is adapted such that the coated surface of the medical device is maintained contact with the supply of wetting liquid during storage. A good shelf-life for the medical device is achieved an where the medical device is a urethral catheter the catheter is immediately “ready-for-use” after the package has been opened.

Claims

1. A storage package comprising a supply of a wetting liquid, a urinary catheter having a coated surface which exhibits reduced friction when wetted with the wetting liquid, and a container within which the catheter and the wetting liquid are contained, wherein the coated surface comprises a coating on a substrate comprising a polyether block amide, and wherein during storage, the coated surface of the urinary catheter is constantly maintained in direct contact with said wetting liquid.

2. The storage package as claimed in claim 1, wherein the container defines a cavity which houses the catheter and the wetting liquid is contained in the cavity in a volume sufficient for the coated surface to remain constantly wetted thereby during storage.

3. The storage package as claimed in claim 2, wherein the cavity is substantially filled with the wetting liquid.

4. The storage package as claimed in claim 2 or 3, wherein the cavity encloses the whole of the urinary catheter.

5. The storage package as claimed in claim 1, wherein the container is of a construction which is impermeable or substantially impermeable to the wetting liquid.

6. The storage package as claimed in claim 1, wherein the container is an inner container and the package further comprises an outer container which encloses the inner container.

7. A storage package, comprising a container which defines a closed cavity, a urinary catheter positioned in the closed cavity and having a coated polyether block amide substrate surface supporting a surface coating which exhibits a reduced friction when wetted with a wetting liquid, and a volume of the wetting liquid in the closed cavity sufficient for the surface coating to be maintained constantly wetted thereby during storage.

8. The storage package as claimed in claim 7, wherein during storage, substantially the whole coated substrate surface of the urinary catheter is constantly maintained in direct contact with said wetting liquid.

9. The storage package as claimed in claim 7, wherein during storage, substantially the whole of the urinary catheter is constantly maintained in direct contact with said wetting liquid.

10. The storage package as claimed in claim 7, wherein the surface coating is provided on a substrate having a melting temperature exceeding 100°

C.

11. The storage package according to claim 10, wherein the urinary catheter is steam-sterilized.

12. The storage package as claimed in claim 7, wherein the container is formed of a material having a melting temperature exceeding 100°

C.

13. The storage package as claimed in claim 12, wherein the container is steam-sterilized.

14. The storage package as claimed in claim 7, wherein the container is impermeable to the wetting liquid.

15. The storage package according to claim 7, wherein the wetting liquid is steam-sterilized.

16. The storage package according to claim 7, wherein the wetting liquid contains an osmolality-increasing agent and/or a pharmaceutically active substance.

17. The storage package as claimed in claim 7, wherein the surface coating is provided on a substrate having a melting temperature exceeding 130°

C.

18. The storage package according to claim 7, wherein the urinary catheter is steam-sterilized.

19. The storage package as claimed in claim 7, wherein the container is formed of a material having a melting temperature exceeding 130°

C.

20. The storage package according to claim 16, wherein the osmolality-increasing agent is sodium chloride.

21. A ready-to-use urinary catheter assembly comprising a container, said container containing a urinary catheter having a hydrophilic layered surface which exhibits a reduced friction when wetted with a wetting liquid, wherein the container is pre-filled with an unenclosed supply of the wetting liquid, whereby during storage, the whole of the hydrophilic layered surface is constantly maintained in direct contact with said wetting liquid.

22. A method for sterile packaging of a urinary catheter having a surface which exhibits a reduced friction when wetted with a wetting liquid, comprising the following steps:

providing a container;

placing the urinary catheter in the container together with the wetting liquid in such a way that the surface of the urinary catheter is maintained in contact with the wetting liquid during storage;

sterilizing the urinary catheter and the wetting liquid; and

scaling the container.

23. The method as claimed in claim 22, wherein the urinary catheter and the wetting liquid are sterilized at the same time.

24. The method as claimed in claim 22 or 23, wherein steam-sterilization is used for sterilizing at least one of the urinary catheter and the wetting liquid.

25. The method as claimed in claim 22 or 23, wherein microwave-sterilization is used for sterilizing at least one of the urinary catheter and the wetting liquid.

26. The method as claimed in any one of claims 22 or 23, wherein the sterilization of the wetting liquid is performed after the sealing of the container.

27. The method as claimed in any one of claims 22 or 23, wherein the sterilization of the urinary catheter is performed after the sealing of the container.

28. The method as claimed in any one of claims 22 or 23, wherein the volume of the wetting liquid placed in the container is sufficient for the surface to remain constantly wetted thereby during storage.

29. The method as claimed in any one of claims 22 or 23, wherein the step of placing wetting liquid in the container comprises placing an amount of the wetting liquid in the container such that during storage, substantially the whole surface of the urinary catheter is constantly maintained in direct contact with said wetting liquid.

30. The method as claimed in any one of claims 22 or 23, wherein the step of placing the wetting liquid in the container comprises placing an amount of wetting liquid in the container such that during storage, substantially the whole urinary catheter is constantly maintained in direct contact with said wetting liquid.

31. The method as claimed in any one of claims 22 or 23, wherein the container is an inner container, comprising the additional step of enclosing the inner container in an additional outer container.

32. The method as claimed in any one of claims 22 or 23, wherein the surface comprises a surface coating on a substrate, wherein the substrate comprises a material having a melting temperature exceeding 100°

C.

33. The method as claimed in claim 32, wherein the substrate is a material selected from the group consisting of polyurethanes, polyether block amides, silicon rubber, elastomeric alloys, and polyolefin alloys based on polypropylene or SEBS (Styrene Ethylene Butadiene Styrene).

34. The method as claimed in any one of claims 22 or 23, wherein the container is formed of a material substantially impermeable to the wetting liquid.

35. The method as claimed in any one of claims 22 or 23, wherein the container is formed of a material having a melting temperature exceeding 100°

C.

36. The method as claimed in any one of claims 22 or 23, comprising the further step of adding an osmolality-increasing agent and/or a pharmaceutically active substance to the wetting liquid.

37. The method as claimed in any one of claim 22 or 23, wherein the urinary catheter is immediately “

ready-for-use”

after the package has been opened.

38. The method as claimed in any one of claims 22 or 23, wherein the surface comprises a surface coating on a substrate, wherein the substrate comprises a material having a melting temperature exceeding 130°

C.

39. The method as claimed in any one of claims 22 or 23, wherein the container is formed of a material having a melting temperature exceeding 130°

C.

40. The method as claimed in claim 36, wherein the osmolality-increasing agent is sodium chloride.

41. A storage package comprising a unrinary catheter having a coated surface which exhibits a reduced friction when wetted with a wetting liquid and a supply of the wetting liquid, wherein the storage package is pre-filled with an unenclosed supply of the wetting liquid, whereby the coated surface of the a urinary catheter is constantly maintained in direct contact with the wetting liquid during storage.

42. The storage package as claimed in claim 41, wherein the storage package comprises a container within which the coated surface and the wetting liquid are contained.

43. The storage package as claimed in claim 42, wherein the container defines a cavity which houses the coated surface and the wetting liquid is contained in the cavity in a volume sufficient for the coated surface to remain constantly wetted thereby during storage.

44. The storage package as claimed in claim 43, wherein the cavity is substantially filled with the wetting liquid.

45. The storage package as claimed in claim 43, wherein the cavity encloses the whole of the urinary catheter.

46. The storage package as claimed in claim 42, wherein the container is of a construction which is impermeable or substantially impermeable to the wetting liquid.

47. The storage package as claimed in claim 42, wherein the container is an inner container and that the package further comprises an outer container which encloses the inner container.

48. The storage package as claimed in claim 41, wherein the coated surface comprises a coating on a substrate, wherein the substrate comprises a polyether block amide.