Device for the combined measurement of the arterial oxygen saturation and the transcutaneous CO2 partial pressure on an ear lobe

• US 6,654,622 B1
• Filed: 12/01/1999
• Issued: 11/25/2003
• Est. Priority Date: 11/19/1999
• Status: Expired due to Term

• Current Assignee: Radiometer Basel AG (Danaher Corporation)
• Original Assignee: Linde Medical Sensors AG (Danaher Corporation)
• Inventors: Palma, Jean-Pierre, Eberhard, Patrick
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US09/452,218
• Time in Patent Office: 1,455 Days
• Field of Search: 600/309-311, 600/322-323, 600/340, 600/344, 600/348, 600/353, 600/354, 600/361, 204/412, 204/403, 204/415
• US Class Current: 600/326
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/6816 Ear lobe

Abstract

A device for the combined measurement of the arterial oxygen saturation and the transcutaneous CO₂ partial pressure on an ear lobe comprises a sensor. The sensor has means for pulse oximetric measurement of the arterial oxygen saturation, means for measurement of the transcutaneous CO₂ partial pressure and means for warming a sensor contact surface intended for contact with the ear lobe. The device makes simple and reliable measurement of the arterial oxygen saturation and the transcutaneous CO₂ partial pressure possible on an ear lobe.

Claims

1. A device for a combined measurement of arterial oxygen saturation and transcutaneous CO₂ partial pressure on an ear lobe, comprising a sensor which has means for pulse oximetric measurement of the arterial oxygen saturation;

means for measurement of the transcutaneous CO₂ partial pressure; and

means for warming a sensor contact surface intended for contact with the ear lobe;

said device further comprising means for attaching said device to an ear lobe such that said device is in contact with the ear lobe with a minimal pressure on the ear lobe for minimizing interference with the pulse oximetric measurement of the arterial oxygen saturation and the transcutaneous CO₂ partial pressure, said sensor being rotatably attached to said means for attaching said device to an ear lobe, said means for pulse oximetric measurement of the arterial oxygen saturation including at least two LEDs and one photodiode which are arranged so that when the device is attached to an ear lobe they are located on the same side of the ear lobe, and which are arranged in depressions forming light channels and point towards the sensor contact surface.

2. Device according to claim 1, in which the light channels are cylindrcal holes.

3. Device according to claim 1 or 2 having a light-reflecting surface which is arranged so that when the device is attached to the ear lobe, the light-reflecting surface is located on the opposite side of the ear lobe relative to the LEDs and the photodiode.

4. Device according to claim 1 or 2, in which the light channels are arranged in a silver block.

5. Device according to claim 4, in which the means for warming the sensor contact surface comprise means for warming the silver block.

6. Device according to claim 1 or 2, in which the means for measurement of the transcutaneous CO₂ partial pressure comprise an Ag/AgCl electrode and a glass pH electrode.

7. Device according to claim 1 or 2, in which the means for measurement of the transcutaneous CO₂ partial pressure comprise an Ag/AgCl electrode and a metal oxide electrode.

8. Device according to claim 1 or 2, in which a sensor contact surface is formed by a reflecting diaphragm which has perforations.

9. Device according to claim 8, in which at least two of the perforations are arranged in front of the means for the pulse oximetric measurement of the arterial oxygen saturation.

10. Device according to claim 8, in which at least one of the perforations is arranged in front of the means for measurement of the transcutaneous CO₂ partial pressure.

11. Device according to claim 1 or 2, having a thermistor to control the temperature on the sensor contact surface.

12. Device according to claim 11 having an additional thermistor to monitor the temperature on the sensor contact surface.

13. Device according to claim 1 or 2, wherein said means for attaching said device to an ear lobe has a clip with a first gripping jaw and a second gripping jaw, with the sensor being attached to the first gripping jaw.

14. Device according to claim 13, in which the sensor on the first gripping jaw is removable.

15. Device according to claim 13, in which an adhesive sheet is attached to the second gripping jaw for making the device adhere to an ear lobe, and the first and the second gripping jaws are pretensioned relative to one another so that when the device is attached to an ear lobe the first gripping jaw is in contact with the ear lobe and exerts a pressure on the earlobe such a that the pulse oximetric measurement of the arterial oxygen saturation and the measurement of the transcutaneous pCO₂ partial pressure are negligibly impaired.

16. Device according to claim 15, in which when the device is attached to an ear lobe the contact pressure of the first gripping jaw on the ear lobe is less than 2500 N/m².

17. Device according to claim 1 or 2, wherein said means for attaching said device to an ear lobe has a retainer to which said sensor is removably attached, said retainer being provided with an a first adhesive sheet to make it adhere to the ear lobe.

18. Device according to claim 17, in which a light-reflecting surface is provided with an adhesive sheet for making it adhere to the side of the ear lobe opposite to the sensor.

19. A device for combined measurement of arterial oxygen saturation and transcutaneous CO₂ partial pressure on an ear lobe, comprising a sensor which has means for pulse oximetric measurement of the arterial oxygen saturation;

means for measurement of the transcutaneous CO₂ partial pressure; and

means for warming a sensor contact surface intended for contact with the ear lobe, said device further comprising means for attaching said device to an ear lobe such that said device is in contact with the ear lobe with a minimal pressure on the ear lobe for minimizing interference with the pulse oximetric measurement of the arterial oxygen saturation and measurement of the transcutaneous CO₂ partial pressure, said sensor being rotatably attached to said means for attaching said device to an ear lobe.

20. Device according to claim 19, wherein said means for attaching said device to an ear lobe is a clip with a first gripping jaw and a second gripping jaw, with the sensor being attached to the first gripping jaws.

21. Device according to claim 20, in which the sensor on the first gripping jaw is removable.

22. Device according to claim 20, in which an adhesive sheet is attached to the second gripping jaw for making the deviceadhere to the ear lobe.

23. Device according to claim 19, in which when the device is attached to the ear lobe the contact pressure of the first gripping jaw on the ear lobe is less than 2500 N/m².

24. Device according to claim 19, in which the sensor is removably and rotatably attached in a retainer which is provided with an adhesive sheet to make it adhere to an ear lobe.

25. A method for measuring arterial oxygen saturation and trancutaneous CO₂ partial pressure on an ear lobe, comprising the steps of

attaching, to an ear lobe, a device comprising means for attaching said device to the ear lobe and a sensor having means for pulse oximetric measurement of the arterial oxygen saturation, means for measurement of the transcutaneous CO₂ partial pressure, and a contact surface for contacting the ear lobe, said sensor being rotatable attached to said means for attaching said device to the ear lobe, so that said contact surface of the sensor contacts the ear lobe so as to minimize interference with the pulse oximetric measurement of the arterial oxygen saturation and the measurement of the transcutaneous CO₂ partial pressure;

warming said contact surface to a temperature such as produces dilation and arterialization of the ear lobe in proximity to said contact surface, and

measuring said arterial oxygen saturation; and

measuring said transcutaneous CO₂ partial pressure,

wherein the steps of measuring said arterial oxygen saturation and measureing said transcutaneous CO₂ partial pressure are performed concurrently with one another.

26. The method of claim 25, wherein said contact surface exerts at the a minimal pressure on the ear lobe while in contact with said ear lobe.

27. The method of claim 26, wherein said at a minimal pressure is less than 2500 N/m².

28. The method of claim 25, wherein said sensor comprises a means for warming said contact surface during said warming step.

29. The method of claim 25, wherein said temperature is in the,range of about 41°

C. to about 45°

C.