TRACHEAL TUBE WITH COLORIMETRIC CO2 INDICATOR

• US 20090095290A1
• Filed: 06/13/2008
• Published: 04/16/2009
• Est. Priority Date: 06/15/2007
• Status: Active Grant

• Current Assignee: Affirm Medical Technologies, LLC
• Original Assignee: Affirm Medical Technologies, LLC
• Inventors: Lee, Stephen, Woodard, Steve, Cain, Janice, Zhang, Sherry, Cain, Brian, Johnson, Fred
• Granted Patent: US 8,720,445 B2
• Time in Patent Office: Days
• US Class Current: 128/202.22
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0468 with valves at the proximal end limiting exhalation, e.g. during speaking or coughing air passages from trachea to oesophagus or to pharynx, artificial epiglottis A61F2/203
• CPC Class Codes: A61M 2016/0413 with detectors of CO2 in exhaled gases
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment

Abstract

Tracheal tubes having an integrated calorimetric CO₂ indicator are provided. In certain embodiment, the integrated CO₂ indicator is selectively sealed from the remainder of the tracheal tube by a removable sterilization barrier. Also provided are CO₂ indicators that exhibit long lasting, breath-to-breath dynamic color change and are storage stable. The devices and compositions of the invention find use in a variety of applications, e.g. in emergent intubation of a subject. Also provided are methods of making the devices and compositions, as well as kits that include the devices and/or compositions of the invention.

Claims

1. A tracheal tube device comprising:

a) an elongated tubular element having;

i) a distal region configured for placement to access the trachea of a subject; and

ii) a proximal region; and

b) a CO₂ indicator present on an inner surface of said elongated tubular element at said proximal region;

wherein said CO₂ indicator is selectively sealed from the remainder of said tracheal tube device by a removable sterilization barrier.

2. The tracheal tube device according to claim 1, wherein said removable sterilization barrier is a film.

3. The tracheal tube device according to claim 2, wherein said film covers inner and outer surfaces of said proximal region of said elongated tubular element.

4. The tracheal tube device according to claim 1, wherein said removable sterilization barrier is a plug.

5. The tracheal tube device according to claim 1, wherein said CO₂ indicator comprises a CO₂ sensitive chemical reagent present on a solid support.

6. The tracheal tube device according to claim 5, wherein said solid support is a flexible solid support.

7. The tracheal tube device according to claim 6, wherein said flexible solid support comprises a cellulosic material.

8. The tracheal tube device according to claim 6, wherein said solid support is configured as a tube dimensioned to fit inside of said elongated tubular element at said proximal region.

9. The tracheal tube device according to claim 1, wherein said CO₂ indicator exhibits breath to breath dynamic color change.

10. The tracheal tube device according to claim 1, wherein said CO₂ indicator is storage stable.

11. The tracheal tube device according to claim 1, wherein all of said device but said CO₂ indicator has been sterilized.

12. A long lasting rapid response reversible CO₂ indicator that exhibits breath to breath dynamic color change.

13. The CO₂ indicator according to claim 12, wherein said CO₂ indicator comprises a CO₂ sensitive chemical reagent present on a solid support.

14. The CO₂ indicator according to claim 13, wherein said solid support is a flexible solid support.

15. The CO₂ indicator according to claim 14, wherein said flexible solid support comprises a cellulosic material.

16. The CO₂ indicator according to claim 15, wherein said solid support is configured as a tube dimensioned to fit inside of an elongated tubular element of an endotracheal tube at a proximal region thereof.

17. The CO₂ indicator according to claim 13, wherein said chemical reagent comprises a pH sensitive indicator dye.

18. The CO₂ indicator according to claim 17, wherein said pH sensitive indicator dye comprises a cresol.

19. The CO₂ indicator according to claim 18, wherein said dye comprises first and second cresols.

20. The CO₂ indicator according to claim 19, wherein said first cresol is m-cresol purple and said second cresol is cresol red.

21. The CO₂ indicator according to claim 13, wherein said chemical reagent further comprises a phase transport enhancer.

22. The CO₂ indicator according to claim 21, wherein said phase transport enhancer is a quaternary ammonium compound.

23. The CO₂ indicator according to claim 22, wherein said cationic quaternary ammonium compound is TBAH.

24-63. -63. (canceled)

64. A tracheal tube device comprising:

a) an elongated tubular element having;

i) a distal region configured for placement to access the trachea of a subject; and

ii) a proximal region; and

b) a CO₂ indicator present on an inner surface of said elongated

tubular element at said proximal region, wherein said indicator is positioned between a first hydrophobic gas permeable barrier and a second transparent barrier.