Potential and diffusion controlled solid electrolyte sensor for continuous measurement of very low levels of transdermal alcohol

• US 5,944,661 A
• Filed: 04/16/1997
• Issued: 08/31/1999
• Est. Priority Date: 04/16/1997
• Status: Expired due to Term

• Current Assignee: Giner, Inc.
• Original Assignee: Giner, Inc.
• Inventors: LaConti, Anthony B., Griffith, Arthur E., Swette, Larry L.
• Primary Examiner(s): Lavinder, Jack W.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US08/840,802
• Time in Patent Office: 867 Days
• Field of Search: 600/309, 600/345-348, 600/352, 600/354, 600/362, 600/363, 204/402, 204/403, 204/406, 204/407, 204/421
• US Class Current: 600/345
• CPC Class Codes: A61B 10/0035 Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2010/0009 Testing for drug or alcohol abuse
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4845 Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: G01N 27/4074 for detection of gases other than oxygen
• CPC Class Codes: G01N 33/4972 Determining alcohol content for vehicle safety devices B60K28/06

Abstract

A method for continuous tracking of blood alcohol, is comprised of 1) a potential- and diffusion-controlled electrochemical solid polymer electrolyte sensor that continuously and concurrently measures very low concentrations of ethanol vapor at the surface of the skin as well as skin properties such as temperature and ionic conductivity, 2) a sensor control circuit, and 3) a data acquisition-recording device. Sensitive and reproducible measurements of ethanol over a wide population range is obtained by simultaneously maintaining the potential of the sensing electrode constant at a voltage above the rest potential of the platinum/air (O₂) electrode and by use of a thin, permselective diffusion-control membrane over the sensing electrode, and in series with the human stratum corneum membrane. The electrochemical oxidation current is a direct measure of the local ethanol vapor concentration over the skin surface.

Claims

1. A transdermal alcohol sensing instrument comprising:

a sensor cell for measuring ethanol vapor at the surface of the skin of a person being monitored;

a potential control circuit for controlling the operation of said sensor cell;

at least one diffusion-control membrane mounted over the sensor cell on the side of said sensor cell designed to contact the skin of the person being measured, said diffusion-control membrane having a lower ethanol permeability than the human stratum corneum, said diffusion-control membrane controlling ethanol and water vapor flux from the skin to the sensor cell.

2. The transdermal alcohol sensing instrument of claim 1, wherein said sensor cell is based on an electrochemical solid polymer electrolyte membrane in a proton exchange form.

3. The transdermal alcohol sensing instrument of claim 2, wherein said sensor cell comprises a sensing electrode which is maintained at a fixed anodic potential equal to or above the Pt/air rest potential.

4. The transdermal alcohol sensing instrument of claim 3, further comprising a potentiostatic circuit for controlling the sensing electrode.

5. The transdermal alcohol sensing instrument of claim 1, further comprising a sensor cell that electrochemically oxidizes ethanol vapor permeating from the skin of the person being measured and concurrently generates a corresponding electrical output signal that is recorded continuously as it is generated at a fixed time interval of 10 to 30 seconds for a plurality of days.

6. The transdermal alcohol sensing instrument of claim 1, wherein said sensor cell comprises a sensing electrode, a reference electrode and a counter electrode.

7. The transdermal alcohol sensing instrument of claim 1, further comprising a wrist band and a power supply, said sensing instrument and power supply being mounted on said wrist band.

8. The transdermal alcohol sensing instrument of claim 1, further comprising a arm band and a power supply, said sensor and power supply being mounted on said arm band.

9. The transdermal alcohol sensing instrument of claim 1, further comprising at least one thermistor for monitoring temperature.

10. The transdermal alcohol sensing instrument of claim 1, further comprising microelectrodes positioned near a sensor cells/skin interface to measure electrical ionic continuity along the skin surface to indicate whether the sensing instrument has been removed from the skin.

11. The transdermal alcohol sensing instrument of claim 1, further comprising a display for displaying measured alcohol values directly at the instrument.

12. The transdermal alcohol sensing instrument of claim 1, further comprising a data recorder for monitoring and quantifying patterns of alcohol consumption over a period of time.

13. The transdermal alcohol sensing instrument of claim 1 wherein said membrane controls water-vapor flux and evaporation to manage humidification of the solid polymer electrolyte membrane and sensor cell.