Packaging system with oxygen sensor

• US 20040188304A1
• Filed: 12/30/2003
• Published: 09/30/2004
• Est. Priority Date: 12/31/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Bonnette, Michael J., Thor, Eric J.
• Granted Patent: US 7,219,799 B2
• Time in Patent Office: Days
• US Class Current: 206/459.1
• CPC Class Codes: B65D 79/02 Arrangements or devices for indicating incorrect storage or transport B65D79/005 takes precedence ; measuring devices G01
• CPC Class Codes: B65D 81/266 for absorbing gases, e.g. oxygen absorbers or desiccants B65D51/244, B65D51/30 take precedence
• CPC Class Codes: G01N 31/225 for oxygen, e.g. including dissolved oxygen
• CPC Class Codes: Y10S 206/807 Tamper proof

Abstract

A packaging system or storage arrangement that includes provision to indicate the presence of oxygen. An oxygen-sensitive material is placed inside a sealable container. Air is evacuated from the sealable container and the sealable container is sealed to isolate the oxygen-sensitive material from oxygen. The sealable container is then irradiated with an effective amount of radiation to activate the oxygen-sensitive material such that the oxygen-sensitive material will undergo a visual change in the presence of oxygen after the oxygen-sensitive material has been irradiated. The visual change provides an indication of the presence of oxygen inside the sealable container.

Claims

1. A method for providing a storage arrangement that indicates the presence of oxygen comprising:

a. placing an oxygen-sensitive material inside a sealable container;

b. evacuating air from the sealable container and sealing the sealable container to isolate the oxygen-sensitive material from oxygen; and

,

c. irradiating the sealable container with an effective amount of radiation to activate the oxygen-sensitive material such that the oxygen-sensitive material will undergo a visual change in the presence of oxygen after the oxygen-sensitive material has been irradiated, the visual change providing an indication of the presence of oxygen inside the sealable container.

2. The method of claim 1, wherein the step of evacuating the air from the sealable container is performed in a vacuum.

3. The method of claim 1, wherein the step of evacuating the air from the sealable container is performed in a non-oxygen gaseous environment.

4. The method of claim 1, wherein the step of irradiating the sealable container involves using gamma radiation to activate the oxygen-sensitive material and to sterilize the sealable container and any contents thereof.

5. The method of claim 1, wherein the oxygen-sensitive material is a plastic material comprising a portion of a medical device, and wherein the sealable container is a sterile medical container, and wherein the step of placing the oxygen-sensitive material inside the sealable container is accomplished by placing the medical device inside the sterile medical container such that the medical device undergoes no visual change until the sterile medical container is opened as long as no significant amount of oxygen is present in the sterile medical container prior to the sterile medical container being opened.

6. The method of claim 1, wherein the visual change of the oxygen-sensitive material indicates a failure of the sealable container.

7. The method of claim 1, wherein the visual change of the oxygen-sensitive material occurs within 8 hours after exposure to a significant amount of oxygen.

8. The method of claim 7, wherein the visual change of the oxygen-sensitive material occurs within 1-2 hours after exposure to the significant amount of oxygen.

9. A storage arrangement including provision for indicating the presence of oxygen comprising:

a. a sealable container that isolates contents of the sealable container from ambient atmosphere when sealed; and

,

b. an oxygen-sensitive material located within the sealable container, the oxygen-sensitive material being a material that undergoes a visual change when in contact with oxygen once the oxygen-sensitive material has been irradiated after the sealable container has been sealed to activate the oxygen-sensitive material.

10. The storage arrangement of claim 9, wherein the oxygen-sensitive material comprises at least a portion of a medical device located within the sealable container such that the medical device itself is an oxygen indicator.

11. The storage arrangement of claim 9, wherein the oxygen-sensitive material comprises a piece of oxygen-sensitive material fixed inside the sealable container and separate from any other contents of the sealable container.

12. The storage arrangement of claim 9, wherein the visual change of the oxygen-sensitive material indicates a failure of the sealable container.

13. The storage arrangement of claim 9, wherein the oxygen-sensitive material is an oxygen-sensitive polymeric composition.

14. The storage arrangement of claim 13, wherein the oxygen-sensitive polymeric composition is a polycarbonate composition activated by an effective amount of gamma radiation.

15. The storage arrangement of claim 14, wherein the effective amount of gamma radiation is from about 25 Kilograys to about 45 Kilograys.

16. The storage arrangement of claim 9, wherein the sealable container comprises:

a. a gas-impermeable foil pouch; and

,

b. a cardboard protective packaging for the foil pouch.

17. The storage arrangement of claim 16, wherein the gas-impermeable foil pouch is a multi-layer package comprising:

a. a silicone oxide treated PET layer;

b. a foil layer;

c. a biaxially oriented nylon layer; and

,

d. a polyethylene layer.

18. The storage arrangement of claim 9, wherein the oxygen-sensitive material is formed as a generally planar chip of oxygen-sensitive material and is operably positioned adjacent to a backing material such that a combination of the backing material and the planar chip of oxygen-sensitive material increases effective visibility of the visual change in the oxygen-sensitive material over visibility of visual change of the oxygen-sensitive material alone.

19. The storage arrangement of claim 9, wherein the oxygen-sensitive material undergoes the visual change within 8 hours after exposure to a significant amount of oxygen.

20. The storage arrangement of claim 19, wherein the oxygen-sensitive material undergoes the visual change within 1-2 hours after exposure to the significant amount of oxygen.

21. The storage arrangement of claim 9, wherein the contents of the sealable container include contents selected from the set consisting of a medical device, a pharmaceutical, a food product, and any combination thereof.

22. The storage arrangement of claim 9, wherein the oxygen-sensitive material is arranged to form at least one symbol that assists in interpreting the visual change of the oxygen-sensitive material.