Tracheal tube with colorimetric CO 2 indicator

• US 8,720,445 B2
• Filed: 06/13/2008
• Issued: 05/13/2014
• Est. Priority Date: 06/15/2007
• Status: Active Grant

• Current Assignee: Affirm Medical Technologies, LLC
• Original Assignee: Affirm Medical Technologies, LLC
• Inventors: Cain, Brian, Cain, Janice, Johnson, Fred, Woodard, Steve, Lee, Stephen, Zhang, Sherry
• Primary Examiner(s): Anderson, Lynne
• Assistant Examiner(s): PHILIPS, BRADLEY H
• Application Number:
  US12/139,136
• Publication Number:
  US 20090095290A1
• Time in Patent Office: 2,160 Days
• Field of Search: 128/205.23, 12820714-20717, 128/200.26, 600/532, 600/353, 600/133, 604/171, 604/199
• US Class Current: 128/207.14
• 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;

ii) a proximal region, wherein the distal region and the proximal region are portions of the same elongated tubular element; and

iii) a longitudinal axis extending from the distal region to the proximal region;

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

c) a removable sterilization barrier, wherein the removable sterilization barrier is a film that has a major extension from a proximal end to a distal end of the CO₂ indicator along the longitudinal axis and selectively seals the CO₂ indicator from the remainder of the tracheal tube device and is configured to be removed from the tracheal tube device before the device is used to intubate a subject without removing the CO₂ indicator.

2. The tracheal tube device according to claim 1, wherein said film covers inner and outer surfaces of said proximal region of said elongated tubular element.

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

4. The tracheal tube device according to claim 3, wherein said solid support is a flexible solid support.

5. The tracheal tube device according to claim 4, wherein said flexible solid support comprises a cellulosic material.

6. The tracheal tube device according to claim 4, wherein said solid support is configured as a tube dimensioned to fit inside of said elongated tubular element at said proximal region.

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

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

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

10. The tracheal tube device according to claim 1, wherein said CO₂ indicator is a long lasting rapid response reversible CO₂ indicator that exhibits breath to breath dynamic color change.

11. The tracheal tube device according to claim 10, wherein said CO₂ indicator comprises a CO₂ sensitive chemical reagent present on a solid support.

12. The tracheal tube device according to claim 11, wherein said solid support is a flexible solid support.

13. The tracheal tube device according to claim 12, wherein said flexible solid support comprises a cellulosic material.

14. The tracheal tube device according to claim 13, wherein said solid support is configured as a tube dimensioned to fit inside of the elongated tubular element at a proximal region thereof.

15. The tracheal tube device according to claim 11, wherein said chemical reagent comprises a pH sensitive indicator dye.

16. The tracheal tube device according to claim 15, wherein said pH sensitive indicator dye comprises a cresol.

17. The tracheal tube device according to claim 16, wherein said dye comprises first and second cresols.

18. The tracheal tube device according to claim 17, wherein said first cresol is m-cresol purple and said second cresol is cresol red.

19. The tracheal tube device according to claim 11, wherein said chemical reagent further comprises a phase transport enhancer.

20. The tracheal tube device according to claim 19, wherein said phase transport enhancer is a quaternary ammonium compound.

21. The tracheal tube device according to claim 20, wherein said cationic quaternary ammonium compound is TBAH.

22. The tracheal tube device according to claim 1, wherein the CO₂ indicator is positioned between a first hydrophobic gas permeable barrier and a second transparent barrier.

23. The tracheal tube device according to claim 1, wherein the removable sterilization barrier is configured to prevent a sterilization component from reaching the CO₂ indicator that is selectively sealed by the barrier.

24. The tracheal tube device according to claim 23, wherein the sterilization component is a gas.

25. The tracheal tube device according to claim 24, wherein the gas is ethylene oxide.

26. The tracheal tube device according to claim 1, wherein the removable sterilization barrier comprises butyl rubber, polyethylene terephthalate, or polytetrafluoroethylene.

27. The tracheal tube device according to claim 1, wherein the removable sterilization barrier is configured to be removed from the tracheal tube device in a single motion when the tracheal tube device is removed from a sterile package.

28. The tracheal tube device according to claim 27, wherein the removable sterilization barrier and the sterile package are formed as one unit.