WO2000037114B1 - Methods and compositions comprising monitoring devices - Google Patents

Methods and compositions comprising monitoring devices

Info

Publication number
WO2000037114B1
WO2000037114B1 PCT/US1999/030508 US9930508W WO0037114B1 WO 2000037114 B1 WO2000037114 B1 WO 2000037114B1 US 9930508 W US9930508 W US 9930508W WO 0037114 B1 WO0037114 B1 WO 0037114B1
Authority
WO
WIPO (PCT)
Prior art keywords
disorder
drug
patient
mycobacterium
disease
Prior art date
Application number
PCT/US1999/030508
Other languages
French (fr)
Other versions
WO2000037114A3 (en
WO2000037114A2 (en
WO2000037114A9 (en
Inventor
Candace Mccombs
Joseph R Lakowicz
Omoefe Abugo
Zygmunt Gryczynski
Original Assignee
Sequella Inc
Univ Maryland
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sequella Inc, Univ Maryland filed Critical Sequella Inc
Priority to AT99968162T priority Critical patent/ATE244022T1/en
Priority to DE69909327T priority patent/DE69909327T2/en
Priority to AU24836/00A priority patent/AU2483600A/en
Priority to EP99968162A priority patent/EP1140210B1/en
Publication of WO2000037114A2 publication Critical patent/WO2000037114A2/en
Publication of WO2000037114A3 publication Critical patent/WO2000037114A3/en
Publication of WO2000037114B1 publication Critical patent/WO2000037114B1/en
Publication of WO2000037114A9 publication Critical patent/WO2000037114A9/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/001Preparation for luminescence or biological staining
    • A61K49/0013Luminescence
    • A61K49/0017Fluorescence in vivo
    • A61K49/0019Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
    • A61K49/0021Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules the fluorescent group being a small organic molecule
    • A61K49/0032Methine dyes, e.g. cyanine dyes
    • A61K49/0034Indocyanine green, i.e. ICG, cardiogreen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0071Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by measuring fluorescence emission
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4833Assessment of subject's compliance to treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/001Preparation for luminescence or biological staining
    • A61K49/0013Luminescence
    • A61K49/0017Fluorescence in vivo
    • A61K49/0019Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
    • A61K49/0021Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules the fluorescent group being a small organic molecule
    • A61K49/0041Xanthene dyes, used in vivo, e.g. administered to a mice, e.g. rhodamines, rose Bengal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/001Preparation for luminescence or biological staining
    • A61K49/0063Preparation for luminescence or biological staining characterised by a special physical or galenical form, e.g. emulsions, microspheres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/001Preparation for luminescence or biological staining
    • A61K49/0063Preparation for luminescence or biological staining characterised by a special physical or galenical form, e.g. emulsions, microspheres
    • A61K49/0069Preparation for luminescence or biological staining characterised by a special physical or galenical form, e.g. emulsions, microspheres the agent being in a particular physical galenical form
    • A61K49/0076Preparation for luminescence or biological staining characterised by a special physical or galenical form, e.g. emulsions, microspheres the agent being in a particular physical galenical form dispersion, suspension, e.g. particles in a liquid, colloid, emulsion
    • A61K49/0082Preparation for luminescence or biological staining characterised by a special physical or galenical form, e.g. emulsions, microspheres the agent being in a particular physical galenical form dispersion, suspension, e.g. particles in a liquid, colloid, emulsion micelle, e.g. phospholipidic micelle and polymeric micelle
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • A61B5/681Wristwatch-type devices
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Primary Health Care (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • General Business, Economics & Management (AREA)
  • Business, Economics & Management (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Medical Treatment And Welfare Office Work (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Testing And Monitoring For Control Systems (AREA)
  • Alarm Systems (AREA)
  • Selective Calling Equipment (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Abstract

Methods and compositions for the detection and monitoring of drug therapy are provided. In particular, efficient and sensitive methods for the detection of drug ingestion are provided for determining whether individuals are complying with prescribed therapeutic regimens, and for providing a mechanism for identifying drug-resistant strains of infectious agents. The claimed methods and compositions involve the application of transdermal devices containing detection mechanisms for receiving and recording signals generated by the ingestion of a labeled drug. Such devices are attached to the skin for the duration of drug therapy and compliance is determined either by direct reading, or by remote monitoring whereby signals are transmitted from the device and received at an external site such as a healthcare facility.

Claims

27AMENDED CLAIMS[received by the International Bureau on 6 November 2000 (06.11.00); original claim 1 amended; new claims 2-19 added (3 pages)]
1. A method for monitoring drug therapy compliance by a human or animal patient comprising contacting the patient with a transdermal detection device capable of receiving a signal from a labeled drug administered to the patient, wherein transdermal detection of the signal indicates that the patient has received a predetermined amount of the labeled drug.
2. The method of Claim 1, wherein the drug is labeled with a fluorescent label, and the transdermal detection device detects a fluorescent signal emitted from the fluorescent label in the patient.
3. The method of Claim 2, wherein the fluorescent label comprises one or more compounds selected from the group consisting of fluorescein, indocyanin green, and rhodamine B.
4. The method of Claim 1, wherein the labeled drug is a drug selected from the group consisting of an antimicrobial agent, antibiotic, antiviral, antidepressant, β-lactam antibiotic, aminoglycoside, macrolide, lincomycin, clindamycin, tetracycline, quinolone, polypeptide, sulfonamide, trimethoprim, sulfamethoxazole, growth factor, lipid, neurotransmitter, vitamin, and mineral.
5. The method of Claim 1, wherein the drug is administered to treat a disease or disorder selected from the group consisting of infectious disease, immunodeficiency disease, cardiovascular disorder, pulmonary disorder, gastrointestinal disorder, hepatic disorder, biliary disorder, endocrine disorder, cancer, musculoskeletal disorder, connective tissue disorder, neurologic disorder, psychiatric disorder, and genitourinary disorder.
6. The method of Claim 1 , wherein the infectious disease is a mycobacterial disease. 28
7. The method of Claim 6, wherein the mycobacterial disease is caused by infection with a Mycobacterial strain selected from the group consisting of Mycobacterium tuberculosis, Mycobacterium avium-intracellular, Mycobacterium kansasii, Mycobacterium frotiutun, Mycobacterium chelonae, and Mycobacterium leprae.
8. The method of Claim 5, wherein the infectious disease is tuberculosis.
9. The method of Claim 5, wherein the psychiatric disorder is a substance abuse disorder.
10. A device for monitoring drug therapy compliance by a human or animal patient, comprising a transdermal signal detector that transdermally detects the presence of a label of a labeled drug administered to the patient.
11. The device of Claim 10, wherein the detector is in electronic communication with a signal transmission system that transmits detection of the label to a remote signal receiving system.
12. The device of Claim 10, wherein the drug is labeled with a fluorescent label, and the transdermal detection device detects a fluorescent signal emitted from the fluorescent label.
13. The device of Claim 12, wherein the fluorescent label comprises one or more compounds selected from the group consisting of fluorescein, indocyanin green, and rhodamine B.
14. The device of Claim 10, wherein the labeled drug is a drug selected from the group consisting of an antimicrobial agent, antibiotic, antiviral, antidepressant, β-lactam antibiotic, aminoglycoside, macrolide, lincomycin, clindamycin, tetracycline, quinolone, polypeptide, sulfonamide, trimethoprim, sulfamethoxazole, growth factor, lipid, neurotransmitter, vitamin, and mineral. 29
15. The device of Claim 10, wherein the drug is administered to treat a disease or disorder selected from the group consisting of infectious disease, immunodeficiency disease, cardiovascular disorder, pulmonary disorder, gastrointestinal disorder, hepatic disorder, biliary disorder, endocrine disorder, cancer, musculoskeletal disorder, connective tissue disorder, neurologic disorder, psychiatric disorder, and genitourinary disorder.
16. The device of Claim 15, wherein the infectious disease is a mycobacterial disease.
17. The device of Claim 16, wherein the mycobacterial disease is caused by infection with a Mycobacterial strain selected from the group consisting of Mycobacterium tuberculosis, Mycobacterium avium-intracellular, Mycobacterium kansasii, Mycobacterium frotiutun, Mycobacterium chelonae, and Mycobacterium leprae.
18. The device of Claim 15, wherein the infectious disease is tuberculosis.
19. A method for monitoring drug therapy compliance in a patient being treated for substance abuse comprising contacting the patient with a transdermal detection device capable of receiving a signal from a labeled drug administered to the patient, wherein transdermal detection of the signal indicates that the patient has received a predetermined amount of the labeled drug.
PCT/US1999/030508 1998-12-21 1999-12-21 Methods and compositions comprising monitoring devices WO2000037114A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AT99968162T ATE244022T1 (en) 1998-12-21 1999-12-21 METHODS OF USE AND COMPOSITIONS CONTAINING MONITORING SYSTEM
DE69909327T DE69909327T2 (en) 1998-12-21 1999-12-21 METHODS OF USE AND COMPILATIONS CONTAINING MONITORING SYSTEM
AU24836/00A AU2483600A (en) 1998-12-21 1999-12-21 Methods and compositions comprising monitoring devices
EP99968162A EP1140210B1 (en) 1998-12-21 1999-12-21 Methods and compositions comprising monitoring devices

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11311698P 1998-12-21 1998-12-21
US60/113,116 1998-12-21

Publications (4)

Publication Number Publication Date
WO2000037114A2 WO2000037114A2 (en) 2000-06-29
WO2000037114A3 WO2000037114A3 (en) 2000-12-21
WO2000037114B1 true WO2000037114B1 (en) 2001-04-26
WO2000037114A9 WO2000037114A9 (en) 2001-07-12

Family

ID=22347656

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/030508 WO2000037114A2 (en) 1998-12-21 1999-12-21 Methods and compositions comprising monitoring devices

Country Status (6)

Country Link
US (3) US6663846B1 (en)
EP (1) EP1140210B1 (en)
AT (1) ATE244022T1 (en)
AU (1) AU2483600A (en)
DE (1) DE69909327T2 (en)
WO (1) WO2000037114A2 (en)

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