Medical article and method of making and using the same

• US 20060054526A1
• Filed: 11/10/2004
• Published: 03/16/2006
• Est. Priority Date: 09/13/2004
• Status: Active Grant

• Current Assignee: SHPP Global Technologies BV (Government of Saudi Arabia)
• Original Assignee: Sabic Innovative Plastics IP BV (Government of Saudi Arabia)
• Inventors: Engel, David B., Schottland, Philippe, Olson, Daniel R., Gascoyne, David, Budris, Jessica Hanley, Potyrailo, Radislav, Wisnudel, Marc, Dean, Jennifer
• Granted Patent: US 7,682,696 B2
• Time in Patent Office: Days
• US Class Current: 206/459.100
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/186 Peroxide solutions
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2202/17 Combination with washing or cleaning means
• CPC Class Codes: A61L 2202/18 Aseptic storing means
• CPC Class Codes: A61L 2202/23 Containers, e.g. vials, bottles, syringes, mail
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: B65D 2401/55 based on a change or a contrast in colour
• CPC Class Codes: B65D 55/026 initial opening or unauthorised access being indicated by a visual change using indicators other than tearable means, e.g. change of colour, pattern or opacity B65D55/066 takes precedence
• CPC Class Codes: Y10S 428/913 Material designed to be responsive to temperature, light, moisture
• CPC Class Codes: Y10T 428/31507 Of polycarbonate
• CPC Class Codes: Y10T 428/31935 Ester, halide or nitrile of addition polymer

Abstract

The packaged medical article can comprise the medical article and a protective layer capable of inhibiting exposure of the medical article to a color change activator prior to use of the medical article. The medical article comprises a plastic portion and an active color changing specie, wherein the color changing specie is capable of changing color after exposure to a color change activator. The method for producing a medical article can comprise: combining thermoplastic resin with a blocked color changing specie to form a resin mixture and manufacture processing the resin mixture to form a packaged medical article. This manufacturing processing comprises forming the resin mixture into the medical article and packaging the medical article to form a packaged medical article. The color changing specie will not affect the structural integrity of the medical article when it changes color.

Claims

1. A packaged medical article, comprising:

the medical article, comprising

a plastic portion; and

an active color changing specie, wherein the color changing specie is capable of changing color after exposure to a color change activator; and

a protective layer capable of inhibiting exposure of the medical article to the color change activator prior to use of the medical article.

2. The medical article of claim 1, wherein the color changing specie comprises a leuco coloring matter selected from the group consisting of leuco azine coloring matter, leuco aryl methane coloring matter, leuco indigo coloring matter, and derivatives and combinations comprising at least one of the foregoing leuco coloring matter.

3. The medical article of claim 1, further comprising a kinetics controller in communication with the color changing specie.

4. The medical article of claim 1, wherein the color change additive is in a coating on the plastic portion.

5. The medical article of claim 4, wherein the coating is on an inner surface of the medical article.

6. The medical article of claim 1, wherein the color change additive is disposed in the plastic portion.

7. The medical article of claim 1, wherein the plastic portion is opaque.

8. The medical article of claim 1, wherein the protective layer comprises removable packaging.

9. The medical article of claim 8, wherein the protective layer has an oxygen permeability of less than or equal to about 1.1 Barrers, and further comprises an oxygen scavengers.

10. The medical article of claim 1, wherein a period of time of 12 hours after an initial exposure of the color changing specie to the color activator has a CEILAB Δ

E* of less than or equal to 4 units.

11. The medical article of claim 10, wherein the period of time is 24 hours.

12. The medical article of claim 1, wherein the color changing specie is capable of a sufficient change in color to obscure a marking on the medical article.

13. The medical article of claim 1, wherein the medical article is selected from the group consisting of medicine containers, medical instruments, and medical packaging around a sterile item.

14. The medical article of claim 13, wherein the medical container is selected from the group consisting of bottles and bubble wrap packages.

15. The medical article of claim 13, wherein the sterile item is selected from the group consisting of bandage, gauze, syringe, and instrument.

16. The medical article of claim 1, wherein the color changing specie is encapsulated.

17. The medical article of claim 1, wherein the color changing specie further comprises a blocking group selected from the group consisting of carbamate, thiocarbamate, enamine, imine, acetal, sulfenyl, sulfonyl, phosphoryl, alkyl, imide, amide, benzylic moiety, and combinations comprising at least one of the foregoing blocking groups.

18. The medical article of claim 1, wherein the color change activator is selected from the group consisting of light, oxygen, rinsing/cleaning solutions hydrogen peroxide, ethylene oxide, body fluids, and combinations comprising at least one of the foregoing.

19. The medical article of claim 1, wherein the color change activator comprises oxygen.

20. The medical article of claim 1, wherein the color changing species comprises an organic color matter.

21. A medical article, comprising:

a plastic portion; and

a blocked color changing specie;

wherein the blocked color changing specie is capable of being active after post-processing, and wherein the post-processing is different than manufacturing processes employed to make the medical article; and

wherein the active color changing specie is capable of changing color after exposure to a color change activator.

22. The medical article of claim 21, wherein the post-processing is selected from the group consisting of ethylene oxide sterilization, enzymatic cleaning, gamma radiation, disinfecting solution, and combinations comprising at least one of the foregoing post-processing.

23. The medical article of claim 21, wherein the blocked color changing specie comprises a blocked leuco dye having the formula:

24. The medical article of claim 21, wherein the blocked color changing specie comprises a blocked leuco dye having the formula:

25. The medical article of claim 21, wherein the active color changing specie comprises a dye having a formula selected from the group consisting of Formula IV and Formula V:

26. The medical article of claim 25, wherein the blocked color changing specie comprises a blocking group selected from the group consisting of —

CO-phenyl, —

SO₂—

C₆H₅, —

CO—

C—

(CH₃)₃, —

CO₂C₂H₅, —

CO-phenyl-NH₂, —

CO-phenyl-alkyl, —

CO-phenyl-alkoxy, —

CO-phenyl-halogen, —

SO₂C₄H₉, -tosyl, and combinations comprising at least one of the foregoing blocking groups

27. The medical article of claim 21, wherein the post-processing is selected from the group consisting of heat, cleaning solution, steam, and combinations comprising at least one of the foregoing post-processing.

28. The medical article of claim 21, wherein the blocked color changing specie is photosensitive, and further comprising a light blocking packaging, wherein the light blocking packaging is capable of preventing exposure of the blocked color changing specie to light.

29. The medical article of claim 21, wherein the color change does not affect functionality of the medical article.

30. The medical article of claim 21, wherein the blocked color changing specie further comprises a blocking group selected from the group consisting of a carbamate, thiocarbamate, enamine, imine, acetal, sulfenyl, sulfonyl, phosphoryl, alkyl, imide, amide, benzylic moiety, peptide moiety, protein moiety, and combinations comprising at least one of the foregoing blocking groups.

31. A method for producing a medical article, comprising:

combining thermoplastic resin with a blocked color changing specie to form a resin mixture; and

manufacturing processing the resin mixture to form a packaged medical article and to deblock the blocked color changing specie, wherein the manufacturing processing comprises

forming the resin mixture into the medical article;

packaging the medical article to form a packaged medical article; and

sterilizing the packaged medical article to form a sterile medical article.

32. The method of claim 31, wherein the processing activates the blocked color changing specie.

33. The method of claim 31, wherein the blocked color change specie remains blocked after the manufacturing processing, and wherein the blocked color changing specie is capable of being activated in a post processing that is different from the manufacturing processing.

34. The method of claim 32, wherein the post processing is selected from the group consisting of ethylene oxide sterilization, enzymatic cleaning, gamma radiation, disinfecting solution, and combinations comprising at least one of the foregoing post-processing.

35. The method of claim 31, wherein the post processing is selected from the group consisting of heat, cleaning solution, steam, and combinations comprising at least one of the foregoing post-processing.

36. The method of claim 31, wherein the blocked color changing specie is photosensitive, and wherein packaging the medical article comprises disposing a light blocking material around the medical article.

37. The method of claim 31, wherein the packaged medical article further comprises a packaging material that inhibits exposure of the sterile medical article to a color change activator such that a CIELAB Δ

E* of greater than or equal to about 5 can occur after the sterile medical article is removed from the packaging and exposed to the color change activator.

38. The method of claim 31, wherein the packaging material comprises an oxygen permeability of less than or equal to about 1.1 Barrers.

39. The method of claim 31, wherein the blocked color changing specie is packaged prior to deblocking.

40. A method for processing a used medical article, wherein a sterile packaged medical article had been opened to form the used medical article, the method comprising:

receiving the used medical article at a first time;

cleaning and sterilizing the used medical article;

sending the used medical article at a second time;

wherein the medical article comprises a plastic portion and a color changing specie; and

wherein the color changing specie has a CIELAB Δ

E* from the first time to the second time of greater than or equal to about 10.

41. The method of claim 40, wherein cleaning and sterilizing the used medical article further comprises deblocking the color changing specie.

42. A method for processing a used medical article, wherein a sterile packaged medical article had been opened to form the used medical article, the method comprising:

wherein the used medical article comprises a color changing specie comprising a block;

deblocking the color changing species in the used medical article.

43. The method of claim 42, wherein deblocking the color changing specie further comprises post processing, wherein the post processing is selected from the group consisting of ethylene oxide sterilization, enzymatic cleaning, gamma radiation, disinfecting solution, and combinations comprising at least one of the foregoing post-processing.

44. The method of claim 42, wherein activating the blocked color changing specie further comprises post processing, wherein the post processing is selected from the group consisting of heat, cleaning solution, steam, and combinations comprising at least one of the foregoing post-processing.