Method of Packaging and Package for Sensors

• US 20100293892A1
• Filed: 11/24/2009
• Published: 11/25/2010
• Est. Priority Date: 12/12/2008
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Carlin, Patrick, Carlin, Gregory J., Fjield, Todd, Higgins, Michael J., Curry, Kenneth
• Application Number:
  US12/624,717
• Publication Number:
  US 20100293892A1
• Time in Patent Office: Days
• US Class Current: 53/403
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: B65D 81/05 maintaining contents at spaced relation from package walls, or from other contents B65D81/022, B65D81/025, B65D81/03 take precedence
• CPC Class Codes: B65D 81/2061 in a flexible container
• CPC Class Codes: B65D 81/2084 in a flexible container

Abstract

There are provided methods of packaging and packages that prevent damage of the package contents while maintaining sterility and that limit the negative effects of sterilization on sensors such as enzyme sensors. A method of packaging an enzyme sensor includes providing an enzyme sensor such as a glucose oxidase sensor in a gas impermeable package comprising one or more of oxygen and water, removing a significant portion of the oxygen and water present in the package, and sealing the package. The resulting package comprises the enzyme sensor in an atmosphere that is substantially free of oxygen and water. The package can also include a pressure indicator that indicates when the package has exceeded a predetermined pressure.

Claims

1. A method of packaging an enzyme sensor, comprising:

providing an enzyme sensor in a gas impermeable package, said package being inflatable and sealable, and comprising one or more of oxygen and water;

removing a significant portion of the oxygen and water present in the package by flushing the package with an inert gas;

inflating the package with excess pressure of said inert gas, and

sealing the package,

wherein the package is inflated such that the packaged material including the enzyme sensor cannot touch more than one non-adjacent surface of the package at a time.

2. The method according to claim 1, wherein said inert gas is nitrogen.

3. The method according to claim 1, further comprising the step of exposing the sealed package to radiation.

4. The method according to claim 3, wherein the radiation is e-beam radiation.

5. The method according to claim 3, wherein the radiation is gamma radiation.

6. The method according to claim 1, wherein the package is a metal foil-lined pouch.

7. The method according to claim 1, wherein the enzyme sensor is a glucose oxidase sensor.

8. The method according to claim 1, wherein the enzyme sensor is provided on a catheter.

9. The method according to claim 8, wherein the catheter is provided on a sheet or tray and affixed thereto.

10. The method according to claim 1, wherein the gas impermeable package is a flexible material.

11. A sensor package, comprising:

an enzyme sensor stored in a sealed gas impermeable package, said package being inflated with an inert gas such that the packaged material including the enzyme sensor cannot touch more than one non-adjacent surface of the package at a time.

12. The package according to claim 11, wherein the package is substantially free of oxygen and water.

13. The package according to claim 11, wherein the package includes no more than 1 mm Hg oxygen.

14. The package according to claim 11, wherein the enzyme sensor is a glucose oxidase sensor.

15. The package according to claim 11, wherein said inert gas is nitrogen.

16. The package according to claim 11, wherein the package is a metal foil-lined pouch.

17. The package according to claim 11, wherein the enzyme sensor is provided on a catheter.

18. The package according to claim 17, wherein the catheter is provided on a sheet or tray and affixed thereto.

19. The package according to claim 11, wherein the gas impermeable package is a flexible material.

20. A method of packaging an enzyme sensor, comprising:

providing an enzyme sensor in a gas impermeable package, wherein at least a portion of the package is a rigid or semi-rigid material and the package comprises one or more of oxygen and water;

removing a significant portion of the oxygen and water present in the package by drawing a vacuum on the package; and

sealing the package.

21. The method according to claim 20, further comprising the step of exposing the sealed package to radiation.

22. The method according to claim 21, wherein the radiation is e-beam radiation.

23. The method according to claim 21, wherein the radiation is gamma radiation.

24. The method according to claim 21, wherein the package comprises a tray.

25. The method according to claim 24, wherein the tray is thermoformed.

26. The method according to claim 25, wherein said sealing step comprises heat sealing a film layer onto said thermoformed tray.

27. The method according to claim 21, wherein the enzyme sensor is a glucose oxidase sensor.

28. The method according to claim 21, wherein the enzyme sensor is provided on a catheter.

29. A sensor package, comprising:

an enzyme sensor stored in a sealed gas impermeable package, said package being vacuum sealed and being substantially free of oxygen and water.

30. The package according to claim 29, wherein the package includes no more than 1 mm Hg oxygen.

31. The package according to claim 29, wherein the enzyme sensor is a glucose oxidase sensor.

32. The package according to claim 29, wherein at least a portion of the package is a rigid or semi-rigid material.

33. The package according to claim 32, comprising a thermoformed tray.

34. The package according to claim 33, further comprising a film layer heat sealed to said thermoformed tray.

35. The package according to claim 29, wherein the enzyme sensor is provided on a catheter.

36. A sensor package comprising:

a pouch including a sensor; and

a pressure indicator that indicates when a particular pressure is reached adjacent the pressure indicator.

37. The package according to claim 36, wherein the pouch includes the pressure indicator.

38. The package according to claim 36, wherein the pressure indicator includes a burst point that avulses when the pressure indicator reaches a predetermined pressure.

39. The package according to claim 36, wherein the pressure indicator includes a color indicator that becomes activated when the pressure indicator reaches a predetermined pressure.

40. The package according to claim 36, wherein the pressure indicator provides an audible sound when the pressure indicator reaches a predetermined pressure.

41. The package according to claim 36, further comprising one or more isolated chambers wherein the isolated chambers include the pressure indicator.

42. The package according to claim 41, wherein the pouch also includes a pressure indicator.

43. The package according to claim 36, wherein the pouch includes an inner pouch and the inner pouch includes a burst point as a pressure indicator when the inner pouch reaches a predetermined pressure.

44. The package according to claim 43, wherein the inner pouch includes an aqueous electrolytic solution and/or a sterilizing agent.