Method and apparatus for remote blood alcohol monitoring

• US 7,611,461 B2
• Filed: 04/25/2006
• Issued: 11/03/2009
• Est. Priority Date: 05/19/2003
• Status: Active Grant

• Current Assignee: Alcohol Monitoring Systems Incorporated
• Original Assignee: Alcohol Monitoring Systems Incorporated
• Inventors: Iiams, Michael Leonard, Hawthorne, Jeffrey Scott, Phillips, Brian Kirby, Roushey, III, William James, Farmer, Jr., Nolan James
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): TOWA, RENE T
• Application Number:
  US11/411,692
• Publication Number:
  US 20060202837A1
• Time in Patent Office: 1,288 Days
• Field of Search: 600300-301, 600/309, 600/353, 600/364, 600/583, 436/68, 436/132, 422/84, 128/920
• US Class Current: 600/300
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: G01N 33/4972 Determining alcohol content for vehicle safety devices B60K28/06
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

A tamper proof transdermal alcohol content monitoring device is made up of analog and digital sides which are securely attached to the human subject to be monitored. The analog side has a sampling circuit which draws a measured insensible skin perspiration sample from the skin of the subject and measured with an electrochemical fuel cell. A distance measurement of the device from the skin of the subject and temperature of the sample are monitored along with the transdermal alcohol content, and converted to digital signals which are transmitted to a modem when the monitor is in proximity to the modem. The signals are stored in the modem and uploaded to a central monitoring station. Automatic alerts may be sent from the central monitoring station to a supervising agency. The supervising agency may also access the information through secured dedicated websites via the Internet.

Claims

1. A blood alcohol monitoring device for continuous remote monitoring of a human subject comprising:

a processing means;

an alcohol sensor means connectable to said processing means for taking a plurality of transdermal alcohol concentration readings at predetermined times without active participation by the human subject;

a drawing means connectable to said processing means for drawing a consistent and predetermined sample across said alcohol sensor means during each of said taking of said plurality of transdermal alcohol concentration readings;

an infrared sensor means connectable to said processing means for taking a plurality of distance readings used for detecting an obstruction between the blood alcohol monitoring device and a portion of skin of the human subject or removal of the blood alcohol monitoring device from the human subject;

a temperature sensor means connectable to said processing means for taking a plurality of temperature readings of said sample from the human subject;

a radio frequency transceiver means connectable to said processing means for transmitting said plurality of transdermal alcohol concentration readings, said plurality of distance readings, and said plurality of temperature readings through radio frequency signals;

a first housing containing said processing means and said radio frequency transceiver means;

a second housing containing said alcohol sensor means, said drawing means, said infrared sensor means, and said temperature sensor means;

a flexible circuit connecting said first housing to said second housing;

an elastic strap connecting said first housing to said second housing;

a conductive strap connecting said second housing to said first housing, wherein said first housing, said flexible circuit, said elastic strap, said second housing, and said conductive strap form a bracelet;

a battery housing insertable in an enlarged channel in said first housing;

a battery insertable in said battery housing for supplying power to the blood alcohol monitoring device;

a battery clip insertable in said enlarged channel and lockably engageable with said battery housing, wherein said battery housing lockably engaged with said battery clip within said enlarged channel is adapted to securely attach the blood alcohol monitoring device to a limb of the human subject;

a continuous signal passed through said first housing, said flexible circuit, said second housing, and said conductive strap, wherein said continuous signal confirms passive identification of the human subject, and further wherein a disruption of said continuous signal indicates that a tamper condition exists;

a modem in communication with the blood alcohol monitoring device through said radio frequency signals, wherein when said tamper condition exists, the blood alcohol monitoring device attempts to communicate said tamper condition to said modem through said radio frequency signals;

an integrated memory connectable to said processing means; and

a communication schedule stored in said integrated memory, wherein the blood alcohol monitoring device attempts to communicate with said modem at times designated in said communication schedule, and further wherein, when the blood alcohol monitoring device fails to communicate with said modem at a scheduled communication time, said modem generates a communication alert along with a date and time of the failed communication, and further wherein, when the blood alcohol monitoring device fails to communicate with said modem for a predetermined period of time, said modem generates a no monitor communication alert along with a present date and time.

2. The blood alcohol monitoring device of claim 1 further comprising:

an obstruction alert logged by the blood alcohol monitoring device along with a date and a time when said processor means, through monitoring said plurality of transdermal alcohol concentration readings, said plurality of distance readings, and said plurality of temperature readings together, determines that an obstruction has been placed between the blood alcohol monitoring device and said portion of skin of the human subject, wherein the blood alcohol monitoring device will attempt to communicate with said modem upon logging said obstruction alert, overriding said communication schedule.

3. The blood alcohol monitoring device of claim 1 further comprising:

a reed relay connectable to said processing means, wherein passing a magnet in proximity to said reed relay overrides said communication schedule and activates the blood alcohol monitoring device to take a transdermal alcohol concentration reading with said alcohol sensor means, to take a distance reading with said infrared sensor means, and to take a temperature reading with said temperature sensor means, and the blood alcohol monitoring device attempts to communicate said transdermal alcohol concentration reading, said distance reading, and said temperature reading through said radio frequency transceiver through said radio frequency signals to said modem.

4. The blood alcohol monitoring device of claim 1 further comprising:

a main program executable by said processing means for controlling the operation of the blood alcohol monitoring device, wherein said main program is downloadable from said modem through said radio frequency signals to said radio frequency transceiver means through said processing means for storage in said integrated memory.

5. The blood alcohol monitoring device of claim 4 wherein said alcohol sensor means further comprises:

a passive electrochemical fuel cell.

6. The blood alcohol monitoring device of claim 5 further comprising:

a characterization table stored in said integrated memory, wherein said characterization table contains the results of a calibration procedure performed on the blood alcohol monitoring device, wherein said characterization table has a plurality of voltage values taken from said passive electrochemical fuel cell, each of said plurality of voltage values being determined by a combination of a temperature reading and an air sample of known alcohol content introduced into the blood alcohol monitoring device, and further wherein said characterization table has a gain value, said gain value determined to be that which will not allow a maximum allowable voltage for the blood alcohol monitoring device to be exceeded;

wherein said processing means extrapolates from said characterization table each of said plurality of transdermal alcohol concentration readings from a peak voltage set by said gain from said sample from said portion of skin of the human subject introduced into said passive electrochemical fuel cell, and from a temperature reading from said sample from the human subject.

7. The blood alcohol monitoring device of claim 1 further comprising:

a bracket attachable to said second housing, wherein said bracket channels said conductive strap towards said first housing, and further wherein said bracket prevents the human subject from manipulating said first housing and said second housing inside out so that a first cover plate of said first housing and a second cover plate of said second housing face outward from said limb of the human subject.

8. The blood alcohol monitoring device of claim 7 wherein said first and second cover plates are made of a surgical stainless steel to prevent skin irritation of the human subject during long-term wear of the blood alcohol monitoring device.

9. The blood alcohol monitoring device of claim 8 further comprising:

a flexible boot attachable to said second cover plate, said flexible boot having a surrounding edge; and

a base plate having a surrounding edge engageable with said surrounding edge of said flexible boot and engageable with a peripheral edge of said second housing;

wherein a collection chamber is bounded by said second cover plate, said flexible boot, and said base plate within said second housing, and further wherein through flexing of said flexible boot in contact with said portion of skin of the human subject creates a suction/vacuum for inducing the drawing of said sample into said collection chamber through a plurality of perforations in said second cover plate.

10. The blood alcohol monitoring device of claim 9 further comprising:

a first sample chamber, connectable through a hydrophobic filter to said collection chamber, having an exit connectible to said drawing means;

a second sample chamber having an inlet connectible to said drawing means;

wherein said drawing means draws said sample from said collection chamber through said first sample chamber through said drawing means and into said second sample chamber and across said alcohol sensor means for taking a one of said plurality of transdermal alcohol concentration readings before expelling said sample out of a vent in said second housing.

11. The blood alcohol monitoring device of claim 1 wherein the human subject cannot remove the blood alcohol monitoring device without damaging at least a one of said first housing, said second housing, said flexible circuit, said conductive strap, said battery housing, and said battery clip.

12. The blood alcohol monitoring device of claim 1 further comprising:

a release tool for removing said battery housing in order to remove the blood alcohol monitoring device from the human subject and for replacing said battery.

13. The blood alcohol monitoring device of claim 1 wherein said first and second housings are waterproof.

14. The blood alcohol monitoring device of claim 1 wherein the continuous remote monitoring of the human subject may be done twenty-four hours a day, seven days a week, 365 days a year.

15. The blood alcohol monitoring device of claim 1 wherein said drawing means is a pump.

16. The blood alcohol monitoring device of claim 1 further comprising:

at least one hydrophobic filter situated along an air flow path inside said second housing, wherein said at least one hydrophobic filter removes moisture from said sample drawn across said alcohol sensor located in said second housing.

17. A method for continuous remote blood alcohol monitoring of a human subject, the method comprising the steps of:

(a) taking with an alcohol sensor, controlled by a central processing unit, a plurality of transdermal alcohol concentration readings at predetermined times without active participation by the human subject;

(b) drawing with a pump, controlled by said central processing unit, a consistent and predetermined sample across said alcohol sensor during each of said taking of said plurality of transdermal alcohol concentration readings;

(c) taking with an infrared sensor, controlled by said central processing unit, a plurality of distance readings used for detecting an obstruction between said infrared sensor and a portion of skin of the human subject or removal of said infrared sensor from proximity to said portion of skin of the human subject;

(d) taking with a temperature sensor, controlled by said central processing unit, a plurality of temperature readings of said sample from the human subject;

(e) passing a continuous signal, controlled by said central processing unit, through a flexible circuit, wherein a disruption of said continuous signal indicates that a tamper condition exits;

(f) transmitting with a radio frequency transceiver, controlled by said central processing unit, through radio frequency signals said plurality of transdermal alcohol concentration readings, said plurality of distance readings, said plurality of temperature readings, any said tamper conditions, and diagnostic data;

(g) configuring said central processing unit and said radio frequency transceiver within a first housing;

(h) configuring said alcohol sensor, said pump, said infrared sensor, and said temperature sensor within a second housing;

(i) connecting said first housing to said second housing with a flexible circuit;

(j) connecting said first housing to said second housing with an elastic strap;

(k) connecting said second housing to said first housing with a conductive strap, wherein said first housing, said flexible circuit, said elastic strap, said second housing, and said conductive strap comprise a monitor device in a form of a bracelet;

(l) encircling said bracelet around a limb of the human subject;

(m) configuring a battery within a battery housing;

(n) inserting said battery housing within an enlarged channel in said first housing; and

(o) inserting a battery clip in said enlarged channel and into said battery housing, lockably engaging said battery clip to said battery housing, wherein said monitor device is thus adapted to securely attach to said limb of the human subject; and

(p) storing a communication schedule in an integrated memory connectable to said central processing unit, wherein said monitor device attempts to communicate with said modem at times designated in said communication schedule.

18. The method according to claim 17 further comprising the steps of:

passing a continuous signal through said first housing, said flexible circuit, said second housing, and said conductive strap, wherein a disruption of said continuous signal indicates that a tamper condition exists; and

when said tamper condition exists, communicating through said radio frequency transceiver through said radio frequency signals an indication of said tamper condition to a modem.

19. The method according to claim 17 further comprising the step of:

downloading a main program from said modem through said radio frequency signals to said radio frequency transceiver to said central processing unit for storage in said integrated memory, wherein said main program is executed by said central processing unit for controlling the operation of said alcohol sensor, said pump, said infrared sensor, said temperature sensor, and said radio frequency transceiver.

20. The method according to claim 19 further comprising the steps of:

monitoring said plurality of transdermal alcohol concentration readings, said plurality of distance readings, and said plurality of temperature readings together to detect if an obstruction has been placed between the monitor device and said portion of skin of the human subject;

when said obstruction has been detected, logging an obstruction alert in said integrated memory along with a date and a time said obstruction was detected;

generating said obstruction alert continuously while said obstruction continues to be detected; and

overriding said communication schedule by attempting to communicate said obstruction alert to said modem.

21. The method according to claim 19 further comprising the steps of:

when the blood alcohol monitoring device fails to communicate with said modem at a scheduled communication time of said communication schedule, generating a communication alert by said modem along with a date and time of the failed communication; and

overriding said communication schedule by the blood alcohol monitoring device and attempting to communicate with said modem after waiting a specified time period until confirmation of said attempting to communicate is received from said modem.

22. The method according to claim 19 further comprising the step of:

when the blood alcohol monitoring device fails to communicate with said modem for a predetermined period of time, generating a no monitor communication alert by said modem along with a present date and time.

23. The method according to claim 19 further comprising the step of:

activating said monitor device and overriding said communication schedule by passing a magnet in proximity to a reed relay connectable to said central processing unit, wherein once activated, said monitor device takes a transdermal alcohol concentration reading with said alcohol sensor, a distance reading with said infrared sensor, and a temperature reading with said temperature sensor, and attempts to communicate said transdermal alcohol concentration reading, said distance reading, and said temperature reading through said radio frequency transceiver through said radio frequency signals to said modem.

24. The method according to claim 19 further comprising the step of:

calibrating said monitor device prior to securely attaching said monitor device to the human subject.

25. The method according to claim 24 wherein said calibrating step further comprises the steps of:

establishing a gain for said monitor device;

generating a characterization table for said monitor device; and

storing said characterization table and said gain in said integrated memory.

26. The method according to claim 25 wherein said establishing step further comprises the steps of:

(1) heating said monitor device to a predetermined maximum temperature;

(2) setting a predetermined default value for said gain;

(3) introducing a maximum allowable alcohol concentration air sample into said monitor device;

(4) measuring a voltage from said alcohol sensor for said maximum allowable alcohol concentration air sample;

(5) comparing said voltage against a predetermined maximum allowable voltage;

(6) if said voltage is less than said maximum allowable voltage, incrementing said predetermined default value for said gain to a next value and repeating steps (3) through (5) until said voltage exceeds said predetermined maximum allowable voltage; and

(7) when said voltage exceeds said predetermined maximum allowable voltage, decrementing said next value to establish said gain.

27. The method according to claim 25 wherein said generating step further comprises the steps of:

(1) heating said monitor device to a predetermined first temperature;

(2) introducing a first known alcohol concentration air sample into said monitor device;

(3) recording a voltage from said alcohol sensor for said first known alcohol concentration air sample in said characterization table for said predetermined first temperature and said first known alcohol concentration air sample;

(4) using said first known alcohol concentration air sample, repeating steps (1) and (3) at a predetermined second temperature, a predetermined third temperature, a predetermined fourth temperature, a predetermined fifth temperature; and

a predetermined sixth temperature;

(5) using a second known alcohol concentration air sample introduced into said monitor device, repeating steps (1), (3), and (4);

(6) using a third known alcohol concentration air sample introduced into said monitor device, repeating steps (1), (3), and (4); and

(7) using a fourth known alcohol concentration air sample introduced into said monitor device, repeating steps (1), (3), and (4).

28. The method according to claim 27 wherein said first known alcohol concentration air sample is 0.00%, said second known alcohol concentration air sample is 0.02%, said third known alcohol concentration air sample is 0.05%, said fourth known alcohol concentration air sample is 0.08%.

29. The method according to claim 27 wherein said predetermined first temperature is 15°

C.;

said predetermined second temperature is 21°

C.;

said predetermined third temperature is 27°

C.;

said predetermined fourth temperature is 33°

C.;

said predetermined fifth temperature is 39°

C.; and

said predetermined sixth temperature is 45°

C.

30. The method according to claim 25 further comprising the step of:

extrapolating by said central processing unit from said characterization table each of said transdermal alcohol concentration readings from a peak voltage set from said gain from said sample introduced in said monitor device from said portion of skin of the human subject, and from a temperature reading of said sample from the human subject.

31. The method according to claim 17 further comprising the step of:

attaching a bracket to said second housing, wherein said bracket channels said conductive strap towards said first housing, and further wherein said bracket prevents the human subject from manipulating said first housing and said second housing inside out so that a first cover plate of said first housing and a second cover plate of said second housing face outward from said limb of the human subject.

32. The method according to claim 31 wherein said first and second cover plates are made of a surgical stainless steel to prevent skin irritation of the human subject during long-term wear of said monitor device.

33. The method according to claim 32 further comprising the step of:

flexing a flexible boot though contact with said portion of skin of the human subject to create a suction/vacuum for inducing the drawing of said sample into a collection chamber through a plurality of perforations in a cover plate bounded by said flexible boot.

34. The method according to claim 33 wherein said drawing step further comprises:

drawing said sample from said collection chamber through a first sample chamber through said pump and into a second sample chamber and across said alcohol sensor for taking a one of said plurality of transdermal alcohol concentration readings before expelling said sample out of a vent in said second housing.

35. The method according to claim 17 further comprising the step of:

situating at least one hydrophobic filter along an air flow path inside said second housing, wherein said at least one hydrophobic filter removes moisture from said sample drawn across said alcohol sensor located in said second housing.

36. The method according to claim 17 wherein the human subject cannot remove said monitor device without damaging at least a one of said first housing, said second housing, said flexible circuit, said conductive strap, said battery housing, and said battery clip.

37. The method according to claim 17 further comprising the step of:

removing said battery housing with a release tool in order to remove said monitor device from the human subject and for replacing said battery.

38. The method according to claim 17 wherein said first and second housings are waterproof.

39. The method according to claim 17 wherein steps (a) through (f) may be performed twenty-four hours a day, seven days a week, 365 days a year.