Medical article and method of making and using the same

• US 7,682,696 B2
• Filed: 11/10/2004
• Issued: 03/23/2010
• Est. Priority Date: 09/13/2004
• Status: Expired due to Fees

• Current Assignee: SHPP Global Technologies BV (Government of Saudi Arabia)
• Original Assignee: Sabic Innovative Plastics IP BV (Government of Saudi Arabia)
• Inventors: Olson, Daniel R., Gascoyne, David, Dean, Jennifer, Budris, Jessica Hanley, Potyrailo, Radislav, Wisnudel, Marc, Engel, David B., Schottland, Philippe
• Primary Examiner(s): Chen; Vivian
• Application Number:
  US10/985,135
• Publication Number:
  US 20060054526A1
• Time in Patent Office: 1,959 Days
• Field of Search: None
• US Class Current: 428/412
• 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 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; and

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.

2. The medical article of claim 1, wherein the blocked color changing specie comprises a blocked leuco dye having the formula:

3. The medical article claim 1, wherein the blocked color changing specie comprises a blocked leuco dye having the formula:

4. The medical article of claim 1, 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.

5. The medical article of claim 1, wherein the color change does not affect functionality of the medical article.

6. The medical article of claim 1, 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.

7. The medical article of claim 1, wherein the plastic portion comprises a thermoplastic resin.

8. The medical article of claim 7, wherein the plastic portion comprises polycarbonate.

9. The medical article of claim 7, wherein the plastic portion comprises polymethyl methacrylate.

10. The medical article of claim 1, wherein the post processing comprises enzymatic cleaning.

11. The medical article of claim 1, wherein the post processing comprises using a disinfecting solution.

12. 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; and

wherein the active color changing specie comprises a dye having a formula selected from the group consisting of Formula IV and Formula V;

13. The medical article of claim 12, 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.

14. 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 sterilization;

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

15. The medical article of claim 14, wherein the sterilization comprises gamma radiation sterilization.

16. The medical article of claim 14, wherein the sterilization comprises electron beam sterilization.

17. The medical article of claim 14, wherein the sterilization comprises ethylene oxide sterilization.

18. The medical article of claim 14, wherein the sterilization comprises autoclaving.