Marker detection method and apparatus to monitor drug compliance

• US 20040081587A1
• Filed: 11/26/2003
• Published: 04/29/2004
• Est. Priority Date: 11/08/1999
• Status: Active Grant

• Current Assignee: David N. Silverman, Richard J. Melker, Samsun Lampotang
• Original Assignee: David N. Silverman, Richard J. Melker, Samsun Lampotang
• Inventors: Melker, Richard J., Lampotang, Samsun, Silverman, David N.
• Granted Patent: US 7,820,108 B2
• Time in Patent Office: Days
• US Class Current: 422/84
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: Y10T 436/104165 Lipid, cholesterol, or triglyceride standard or control
• CPC Class Codes: Y10T 436/13 Tracers or tags

Abstract

The present invention includes a method and apparatus for monitoring drug compliance by detecting markers, such as odors, upon exhalation by a patient after medication is taken, wherein such markers result either directly from the medication itself or from an additive combined with the medication. In the case of olfactory markers, the invention preferably utilizes electronic sensor technology, such as the commercial devices referred to as “artificial noses” or “electronic noses,” to non-invasively monitor compliance. The invention further includes a reporting system capable of tracking compliance (remote or proximate) and providing the necessary alerts.

Claims

1. A method of determining patient compliance in taking a medication, comprising

providing to the patient a combination of a medication and a detectable marker, the combination to be taken by the patient as a result of the patient'"'"'s own actions,

obtaining a sample of the patient'"'"'s gaseous exhaled breath;

and

analyzing the sample of the patient'"'"'s breath to confirm the presence or absence of said marker in the patient'"'"'s breath as an indication of patient compliance or non-compliance in taking the medication;

wherein the medication is to be taken by volitional patient action at specified times.

2. The method of claim 1 wherein the medication itself comprises said detectable marker.

3. The method of claim 1 wherein the marker is an odorous substance.

4. The method of claim 3 wherein the sample of the patient'"'"'s breath is analyzed to confirm the presence of said marker by sensor technology selected from semiconductor gas sensor technology, conductive polymer gas sensor technology, or surface acoustic wave gas sensor technology.

5. The method of claim 4 wherein the sensor technology produces a unique electronic fingerprint to characterize the marker such that the presence and concentration of the marker is determined.

6. The method of claim 1 wherein the marker is a flavor ingredient selected from trans-Anethole (1-methoxy-4-propenyl benzene)—

anise;

Benzaldehyde (benzoic aldehyde)—

bitter almond;

Butyl isobutyrate (n-butyl 2, methyl propanoate)—

pineapple;

Cinnamaldehyde (3-phenylpropenal)—

cinnamon;

Citral (2-trans-3, 7-dimenthyl-2, 6-octadiene-1-al)—

citrus;

Menthol (1-methyl-4-isopropylcyclohexane-3-ol)—

menthol; and

alpha-Pinene (2, 6, 6-trimethylbicyclo-(3,1,1)-2-heptene)—

pine.

7. The method of claim 1 wherein the sample of the patient'"'"'s breath is analyzed to confirm the presence of said marker by a spectrophotometer.

8. The method of claim 1 wherein the sample of the patient'"'"'s breath is analyzed to confirm the presence of said marker by mass spectrometer.

9. The method of claim 1 wherein the marker is an additive combined with the medication.

10. The method of claim 1 wherein the marker is a coating on the medication.

11. The method of claim 10 wherein a substance to stimulate salivation is included with the marker.

12. The method of claim 1 wherein the marker is included with a liquid medication.

13. The method of claim 1 wherein the marker is included with a pulmonary delivered medication.

14. The method of claim 1 wherein the marker is included with an intranasal delivered medication.

15. The method of claim 1 wherein the marker is included with intravenously delivered medication.

16. The method of claim 1 further comprising the step of recording data resulting from analysis of the sample of the patient'"'"'s breath.

17. The method of claim 1 further comprising the step of transmitting data resulting from the analysis of the sample of the patient'"'"'s breath.

18. The method of claim 1 where the analysis of the sample of the patient'"'"'s breath includes comparing the marker sensed in the sample of the patient'"'"'s breath with a predetermined signature profile of a specific marker.

19. The method of claim 18 wherein the predetermined signature profile of a specific marker is associated with a specific drug.

20. The method of claim 18 wherein the predetermined signature profile of a specific marker is associated with a class of drugs.

21. The method of claim 1 further comprising the step of capturing the sample of the patient'"'"'s breath in a vessel prior to analysis.

22. The method of claim 1 further comprising the step of dehumidifying the sample of the patient'"'"'s breath prior to analysis.

23. The method of claim 1 wherein the marker first reacts with enzymes in the patient'"'"'s mouth to be detectable.

24. The method of claim 1 wherein the marker first reacts with acids in the patient'"'"'s stomach to be detectable.

25. The method of claim 1 wherein the marker is absorbed in the patient'"'"'s gastrointestinal tract and excreted in the lungs.

26. The method of claim 1 wherein the data resulting from analysis of the sample of the patient'"'"'s breath includes marker concentration and, thus, medication concentration.

27. The method of claim 1 further comprising the step of identifying a baseline marker spectrum for the patient prior to the patient'"'"'s taking of the medication.

28. The method of claim 1 wherein said analysis further includes detecting exhalation of the patient'"'"'s breath with a sensor.

30. The method of claim 1 wherein the marker is included with transdermally delivered medication.

29. A method of producing medication which is detectable as an indication of patient compliance in taking the medication comprising the steps of:

identifying a marker substance detectable in gaseous exhaled breath, and

producing a medication combined with said detectable marker substance, said medication to be taken by volitional patient action at specified times whereby subsequent analysis of the patient'"'"'s breath will confirm the presence of said marker substance and thus the patient'"'"'s compliance in taking said medication.