Monitoring drug compliance, food-intake or toxin-intake using non-invasively-read labels

• US 20080213904A1
• Filed: 08/23/2007
• Published: 09/04/2008
• Est. Priority Date: 08/24/2006
• Status: Abandoned Application

• Current Assignee: Bryan T. Oronsky, Carol A. Tosaya, Herbert L. Berman, John W Sliwa
• Original Assignee: Bryan T. Oronsky, Carol A. Tosaya, Herbert L. Berman, John W Sliwa
• Inventors: Sliwa, John W., Tosaya, Carol A., Oronsky, Bryan T., Berman, Herbert L.
• Application Number:
  US11/895,400
• Publication Number:
  US 20080213904A1
• Time in Patent Office: Days
• US Class Current: 436/56
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/117 Identification of persons methods or arrangements for recognising patterns, e.g. fingerprints, G06F18/00, G06V40/00; identification of persons by analysing their voice or speech G10L17/00
• CPC Class Codes: A61B 5/1171 based on the shapes or appearances of their bodies or parts thereof
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/71 thermally excited
• CPC Class Codes: Y10T 436/13 Tracers or tags

Abstract

A system is disclosed for monitoring a property of an ingested or in-taken drug, food, drink or toxic substance, non-invasively or minimally invasively, which can also identify the subject person being monitored, if desired. The system comprises: a means of labeling the substance with a labeling media to have a useful signature indicative of, or bearing a relation to the property; a means to allow the signature to be read non-invasively or minimally invasively; and a means to identify, in any manner, who is being monitored.

Claims

1. A system for monitoring a property of an ingested or intaken drug, food, drink or toxic substance, non-invasively or minimally invasively, which can also identify the subject person being monitored, if desired, comprising:

a means of labeling the substance with a labeling media to have a useful signature indicative of, or bearing a relation to the property;

a means to allow the signature to be read non-invasively or minimally invasively; and

a means to identify, in any manner, who is being monitored.

2. The system of claim 1 wherein the identification means is biometric in nature.

3. The system of claim 1 wherein the identification means includes at least one of:

a) a retinal scanner, b) a hand scanner, c) a facial-recognition system, d) a speech or voice-recognition system, e) any type of finger or hand scanner, f) a fingerprint scanner, g) a password, h) a memory dongle, i) an ID card, j) any type of person-unique optical signature, k) a vein pattern, l) any eye related pattern, or m) any type of implanted or body-attached ID chip, transmitter or transceiver whether removable by the wearer or not.

4. The system of claim 1 wherein the labeling media is or contains any one or more of:

a) a nanoparticle, b) a quantum dot, c) a microparticle, d) an isotope, e) a fluorophore or chromophore, f) a micromachined or lithographically derived particle or member, g) any particle with a known size or shape, h) any particle with a known size or shape distribution, i) any particle with a known coating system, j) any particle with a functional microbiological coating, overlayer or outer surface, k) any particle having an optically interactive or unique thin-film or pattern, or l) any particle having an electromagnetically interactive unique signature, including a patterned microantenna.

5. The system of claim 1 being contained in, for use with, or being an interfacing or dependant peripheral of a PDA, cellphone, music/video player, dongle, ID card or other personal or personalized electronic product.

6. The system of claim 1 wherein the system allows for contact-free, spaced or distant monitoring of said substance.

7. The system of claim 1 wherein the system allows for momentary contact monitoring of said substance.

8. The system of claim 1 wherein the system allows for skin or mucous-membrane contact monitoring of said substance.

9. The system of claim 1 wherein the system allows for monitoring of said substance through a transdermal or trans-tissue window or port.

10. The system of claim 1 wherein the monitored person is not identified by the inventive system itself because one of:

a) someone chooses not to despite having the choice or capability, b) software chooses not to, or c) identification means are not included as part of the inventive system.

11. The system of claim 1 wherein the monitored person is identified by other means, including:

a) the patient'"'"'s own input, b) a practitioner'"'"'s, doctor'"'"'s or clinician'"'"'s input, c) a technician'"'"'s input, d) input from a patient tracking or identification means not an integrated physical part of the inventive system.

12. The system of claim 1 with or without system-included identification means for identifying the patient, wherein the labeling approach or media utilizes at least one of:

a) one or more nanoparticles with or without a controlled size, shape or compositional parameter;

b) one or more microparticles with or without a controlled size, shape or compositional parameter;

c) one or more quantum dots with or without a controlled size, shape or compositional parameter;

d) one or more fluorophores, phosphors or chromophores;

e) one or more absorbing, adsorbing, attenuating, diffracting or polarizing materials;

f) one or more electrically chargeable or magnetic materials;

g) one or more micromachined, lithographically-derived or micromolded-derived materials or particles;

h) one or more particles having a biologically functional coating or entity on, in or under its surface;

i) one or more biologically or chemically targeted particles or materials;

j) one or more carbon nanotubes or buckeyballs;

k) one or more providers of a spectral or signal background from which labels subtract-from, modulate, or mask said background signature or signal;

l) an additive label;

m) a subtractive label;

n) a label which is read using two or more energy fluxes or fields;

o) a label which is read using acoustics or acoustic cavitation;

p) a label which is read in the visible, infrared or x-ray wavelengths;

q) a label which is read by a polarization detection or quantification means;

r) a label which is read using any excitation or biasing field or energy;

s) a label not requiring excitation or field-exposure for reading;

t) a label providing information on a drug concentration presently chemically or metabolically available to the body;

u) a label providing information on a drug concentration which can potentially become chemically or metabolically available to the body;

v) a label providing information on a drug concentration which has been utilized by the body or already made available to the body-whether chemically or metabolically altered or not;

w) a label utilizing one or more selected isotopes of one or more elements;

x) a label utilizing a controlled ratio of isotopes, fluorophores or chromophores;

y) any label having a unique decay parameter such as an optical decay time;

or

z) any label that exhibits a nuclear emission or decay signature.

13. The system of claim 1 wherein the system provides for any one or more of:

a) home use;

b) ambulatory use;

c) enforced use;

d) location-tracking of the patient or a usage event or noncompliance;

e) bed-use;

f) self-use;

g) automated operation;

h) physically remote monitoring across a physical distance but in the same general location-as monitoring optically or using Bluetooth®

wireless connection from across the room using light waves or radio waves passing across said room;

i) monitoring over a network, wireless or wired;

j) recording of compliance or noncompliance;

k) trend recording or statistics generation;

l) corrective-action feedback to the patient whether by software or by a human practitioner or both;

m) authorization of drug dispensing or prescriptions;

n) discrete use such a system as when it appears to only be a cell phone or PDA;

o) control of a drug depot such as a pump, patch or implanted storage entity;

or

p) adjustment of recommended dose or ingestion based on the physical or mental state of the patient or subject.

14. The system of claim 1 wherein the system signature-detection means is split into two or more portions, with at least one portion mounted on or in the patient tissues and at least one other portion which can be otherwise carried or located nearby—

not necessarily carried or on the body.

15. The system of claim 14 wherein at least two sensing portions are connected, at least occasionally, by one or more of:

a) a cable or wired connection;

b) a wireless electrical or optical connection;

c) a placement of one portion in proximity or contact with the other at least momentarily;

d) a temporary physical contacting of the two said portions;

or

e) the plugging-in of a connectorized pluggable entity.

16. The system of claim 1 wherein patient-identification includes one or more of:

a) identification by true name, b) identification by an alphanumeric or numeric identifier, c) identification by a nontrue alias, “

handle”

or substitute name, d) identification as being one of a specific trait—

such as male, female, trustworthy, nontrustworthy, e) identification as being a person for which prior data has been taken using an inventive system or the particular inventive system, f) identification as being in or from a specific location or area, g) identification as by storage and recognition of any biometric signature—

such as a vein pattern, h) identification as a substance abuser, i) identification as someone in potential danger of a bad drug interaction, j) identification which triggers or is enabled or authorized by the reading-of or writing-to a medical record, or k) identification that involves relating or reporting a prescription or diagnosis to that particular patient or to his/her caregiver.

17. The system of claim 1 wherein the system is one of:

a) voluntarily worn or used by the patient or subject;

b) involuntarily worn or used by the patient or subject;

c) locked upon the patient'"'"'s body;

or

d) worn under the clothing.

18. The system of claim 1 further including at least one excitation filter and at least one emission filter to respectively stimulate and detect fluorescence from ingesting fluorophores and/or chromophores.

19. A method for monitoring drug therapy compliance by a human or animal patient consisting of a device that can detect a signal from a labeled pill, chewable capsule, lozenge, suppository, ingestible tablets, buccal tablets, troches, elixirs, suspensions, syrups, wafers, and the like administered to the patient and determining from the presence or absence of said detection whether said patient has ingested or received said pill, capsule or liquid in compliance with the medication regimen.

20. The method of claim 19 wherein said pill, capsule, lozenge, suppository or liquid is a therapeutic substance selected from the group consisting of agents for the common cold, anti-addiction, anti-infectives, analgesics, anesthetics, anorexics, antiarthritics, anti-allergy agents, antiasthmatic agents, anticonvulsants, anti-depressants, antidiabetic agents, anti-depressants, anti-diuretics, anti-emetics, anti-histamines, anti-inflammatory agents, antimigraine preparations, antimotion sickness preparations, antinauseants, antineoplastics, anti-obesity, antiosteoporeteic, anti-parkinsonism drugs, antipruritics, antipsychotics, antipyretics, anticholinergics, benzodiazepine antagonists, bone stimulating agents, central nervous system stimulants, hormones, hypnotics, immunosuppressives, prostaglandins, proteins, peptides, polypeptides and other macromolecules, psychostimulants, rhinitis treatment, sedatives, sexual hypofunction, vaccines, tranquilizers, nutrients vitamins, minerals, herbs, and water.

21. The method of claim 19 wherein the device consists of an NIR source which either backlights the general target area or illuminates it reflectively or transmissively, thereby providing an optical contrast or an optical indication of a portion of the vasculature.

22. The method of claim 19 wherein a camera or detector is utilized and that camera or detector includes at least one of a) a CMOS chip, b) a CCD chip, c) a chip having both visible and infrared sensitivity, d) a photodetector chip designed for a specific wavelength range such as mid-IR, near-IR or infrared in general.

23. The method of claim 19 wherein the observer

(a) looks at a digital or analog readout or a set of lights related to the presence or absence of a specific fluorophore signal;

(b) looks through an optical window, filter, lens or shutter;

(c) listens to an audible feedback signal which is related to the presence or absence of a specific fluorophore signal;

or

(d) feels a tactile feedback signal which is related to the presence or absence of a specific fluorophore signal.

24. The method of claim 19 wherein a reader is present which serves to interpret the type and strength of signal received in order to determine specific parameters such as the name of the drug which was taken, its concentration, and the sex and/or name of the person intended to receive the medication.

25. The method of claim 24 wherein a kit is provided which contains a reservoir of a specific fluorophore in the form of a dropper or spray, which the patient can use to apply the fluorophore to their pills for the purposes of identification in order to differentiate them from another person'"'"'s pills.

26. The method of claim 25 wherein multiple fluorophores or chromophores are detectable with a light that causes fluorescence, one of said fluorophores or fluorophore combinations causing a different fluorescent coloration of a portion of the vasculature than the fluorescent coloration caused by other fluorophores or fluorophore combinations.

27. The method of claim 24 wherein a kit is provided that contains a reservoir of a specific fluorophore in the form of a dropper or spray, which a third person can administer to the food of an anorexic or bulimic patient in order to determine whether the food was actually ingested and absorbed into the blood stream.

28. The method of claim 24 wherein a kit is provided that contains a master chart or template so that the observer can interpret the signal received by matching its color or intensity to a specific parameter on the chart.

29. The method of claim 24 wherein a timer unit is present which is continuously running and internally maintains the current time, the timer optionally being provided with a memory to store the viewing times for later retrieval.

30. The method of claim 19 wherein said composition is a medication or medication composition.

31. The method of claim 19 which consists of visually observing the vasculature of said patient to determine the presence or absence of a fluorophore signal.

32. The method of claim 19 wherein the pill is labeled with a fluorophore, specific concentration of a fluorophore(s) or combination of fluorophores in order to provide a drug-specific signature or drug dose estimation.

33. The method of claim 32 wherein said fluorophore or fluorophores include any one or more of rhodamine, indocyanine-green (IcG), fluoroscein, phenyl alanine, tyrosine, tryptophan, retinol, riboflavin, pryidioxin, A-tocopherol, NADH, ATP, chlorophyll-a, hematoporphyrin, or quinine.

34. The method of claim 32 wherein one of said fluorophores causes a different coloration or intensity than another of said fluorophores.

35. The method of claim 19 further comprising providing multiple fluorophores in combination wherein one of said fluorophore combinations results in a different coloration or coloration pattern in the vasculature than another of said fluorophore combinations.

36. The method of claim 19 further comprising providing multiple fluorophores in combination, causing coloration detectable with a light which causes fluorescence which is visually observable for determining whether said patient has ingested said combination in compliance with a medication regimen and for determining a time frame in which the combination was ingested.

37. The method of claim 19 wherein the pill is labeled with a ferromagnetic or paramagnetic substance detectable with a coil as in NMR and other detection methods in order to provide a drug-specific signature or drug dose estimation.

38. The method of claim 19 wherein patient-identification includes one or more of:

a) identification by true name, b) identification by an alphanumeric or numeric identifier, c) identification by a non-true alias, “

handle”

or substitute name, d) identification as being one of a specific trait—

such as male, female, trustworthy, nontrustworthy, e) identification as being a person for which prior data has been taken using an inventive system or the particular inventive system, f) identification as being in or from a specific location or area, g) identification as by storage and recognition of any biometric signature—

such as a vein pattern, h) identification as a substance abuser, i) identification as someone in potential danger of a bad drug interaction, j) identification which triggers or is enabled or authorized by the reading-of or writing-to a medical record, or k) identification which involves relating or reporting a prescription or diagnosis to that particular patient or to his/her caregiver.

39. The method of claim 19 wherein the system is one of:

a) voluntarily worn or used by the patient or subject;

b) involuntarily worn or used by the patient or subject;

c) locked upon the patient'"'"'s body;

or

d) worn under the clothing.

40. A database or storage means for at least one patient including:

a) patient identity or tracking information, including a name or biometric signature;

or

b) patient monitoring data or useable memory space for such for at least one patient ingested or ingestable substance,

the patient wearing, carrying, presenting oneself to or having a monitoring system capable of both said monitoring and said identification, the database being anywhere including being remotely located and/or on the patients system.

41. The database or storage means of claim 40 wherein at least one of:

a) patient data is transferred over a wired or wireless network;

b) patient data is compared to the data of a population of patients or subjects;

c) patient date is statistically analyzed at any point or any location;

d) patient data is reported to anyone in any manner;

e) patient data is contained in a controlled-access database;

f) patient data includes data relating to potential drug interactions;

g) patient data includes data relating to the health state of the patient;

or

h) patient data is sampled over time, whether automatically or manually.

42. The database or storage means of claim 40 wherein the monitoring system is one of:

a) voluntarily worn or used by the patient or subject;

b) involuntarily worn or used by the patient or subject;

c) locked upon the patient'"'"'s body;

or

d) worn under the clothing.

43. Apparatus for detecting a fluorescent signature from at least one ingested fluorophore, the apparatus comprising:

a collimated light source that emits electromagnetic radiation in the UV to blue region;

an excitation filter through which the electromagnetic radiation is passed;

a dichroic mirror that passes relatively shorter wavelengths and reflects relatively longer fluorescent wavelengths;

means for directing the first electromagnetic radiation onto an area of a body containing the at least one ingested fluorophore to thereby cause fluorescent radiation to be emitted from the at least one ingested fluorophore;

means for receiving the fluorescent radiation, the fluorescent radiation being longer than the electromagnetic radiation and thereby reflected off the dichroic mirror;

an emission filter through which the fluorescent radiation is passed; and

an optical detector for detecting the fluorescent radiation.

44. The apparatus of claim 43 further including a power supply for providing power to the collimated light source and the optical detector.

45. The apparatus of claim 43 wherein the excitation filter is centered on 417 nm, with a bandwidth of 60 nm.

46. The apparatus of claim 43 wherein the emission filter is centered on 697 nm, with a bandwidth of 75 nm.

47. The apparatus of claim 43 wherein the at least one fluorophore is selected from the group consisting of rhodamine, indocyanine-green (IcG), fluoroscein, phenyl alanine, tyrosine, tryptophan, retinol, riboflavin, pryidioxin, A-tocopherol, NADH, ATP, chlorophyll-a, hematoporphyrin, and quinine.