Monitoring system for the regular intake of a medicament

• US 6,081,734 A
• Filed: 01/29/1999
• Issued: 06/27/2000
• Est. Priority Date: 08/16/1996
• Status: Expired due to Fees

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Inventors: Batz, Hans-Georg
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/147,601
• Time in Patent Office: 515 Days
• Field of Search: 600/310, 600/314, 600/317, 600/322, 600/347, 600/365, 424/9.6, 424/9.61
• US Class Current: 600/314
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: G01N 33/582 with fluorescent label
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A control system for monitoring the regular intake of a medicament by a patient. The system comprises system components mutually tuned to each other and comprising a medicine dosage form (1) for the medication and a detection apparatus (2) for non-invasive detection, within the body of the patient, of a detection substance contained in the medicine dosage form (3). The detection apparatus (2) is adapted for reagent-free direct measurement of a physically measurable parameter correlated with the presence of the detection substance in the body of the patient.

Claims

1. System for monitoring the regular intake of a medicament by a patient, characterized in that,

it includes mutually adapted system components comprising a medicine dosage form containing the medicament and a detection apparatus for non-invasive detection of a substance contained in the dosage form within the body of a patient, wherein

the non-invasively detectable substance contained in the dosage form is a non-toxic marking substance which differs from the medicament and

the detection apparatus is adapted for reagent-free direct measurement of a physically measurable parameter correlated with the presence of the substance in the body of the patient and comprises determination means for determination of the time dependent change of the parameter to detect intake of the medicament.

2. Monitoring system according to claim 1, characterized in that the marking substance measurably influences electromagnetic radiation irradiated into the body and the detection apparatus comprises irradiation means for the irradiation of electromagnetic radiation into the body of the patient as well as detection means for measurement of a measuring quantity of the exiting radiation following interaction between the electromagnetic radiation and the marking substance, as a parameter correlated to the presence thereof in the body.

3. Monitoring system according to claim 2, characterized in that the electromagnetic radiation is light.

4. Monitoring system according to claim 3, characterized in that the irradiation means are configured for irradiation of a plurality of wavelengths of the electromagnetic radiation and the spectral dependence of the parameter is utilized for detection of the marking substance.

5. Monitoring system according to claim 3, characterized in that the light is in the visible or infrared range of the optical spectrum.

6. Monitoring system according to claim 3, characterized in that the detection apparatus comprises irradiation means for irradiation of the electromagnetic radiation at a plurality of differing irradiation locations and/or detection means for detection of the electromagnetic radiation at a plurality of differing detection locations and the marking substance is detected on the basis of the dependence of the detected parameter on the measuring distance between a respective irradiation location and a respective detection location.

7. Monitoring system according to claim 1, characterized in that the marking substance contains a fluorescent dye and the detection apparatus is adapted for in vivo detection of the fluorescence as the parameter is correlated to the presence of the marking substance in the body.

8. Monitoring system according to claim 1, characterized in that the detection apparatus comprises a sensor unit which can be carried on the body.

9. Monitoring system according to claim 1, characterized in that the detection apparatus is configured in the form of a device conventionally worn on the body.

10. Monitoring system according to claim 9, wherein the device is a wrist watch.

11. Monitoring system according to claim 1, characterized in that the detection apparatus comprises a time measuring device and a memory for the storage of data concerning the detection of the marking substance.

12. Monitoring system according to claim 11, characterized in that the detection apparatus produces a warning signal if no marking substance is detectable within the body of the patient within a predetermined period of time.

13. Monitoring system according claim 1 characterized in that the detection apparatus comprises a port for the transfer of data to an external inquiry unit.

14. Monitoring system according to claim 1, characterized in that the detection apparatus comprises a transmitter for the wireless transmission of the data to an external inquiry unit.

15. Medicine dosage form for a monitoring system according to claim 1, characterized in that the dosage form includes, in addition to an active agent, a non-toxic marking substance whose presence in the body of the patient can be measured in a non-invasive fashion using the detection apparatus.

16. Medicine dosage form according to claim 15, characterized in that the marking substance contains a fluorescent dye.

17. Medicine dosage form according to claim 15, characterized in that the marking substance is rendered non-toxic by capsulation or by incorporation within a macromolecular protective molecular structure.

18. Medicine dosage form according to claim 17, characterized in that the macromolecular protective molecular structure belongs to the group comprising dendrimeres and fullvalenes.

19. System for monitoring the regular intake of a medicament by a patient, characterized in that, it includes mutually adapted system components comprising a medicine dosage form containing the medicament and a detection apparatus for non-invasive detection of a substance contained in the dosage form within the body of a patient, wherein the detection apparatus is adapted for reagent-free direct measurement of a physically measurable parameter correlated with the presence of the substance in the body of the patient and comprises determination means for determination of the time dependent change of the parameter to detect intake of the medicament, the medicament measurably influences electromagnetic radiation irradiated into the body and the detection apparatus comprises irradiation means for the irradiation of light into the body of the patient as well as detection means for measurement of a measuring quantity of the exiting light following interaction between the electromagnetic radiation and the medicament, as a parameter correlated to the presence thereof in the body and the irradiation means are configured for irradiation of a plurality of wavelengths of the electromagnetic radiation and the spectral dependence of the parameter is utilized for detection of the marking substance.

20. Monitoring system according to claim 19, characterized in that the light is in the visible or infrared range of the optical spectrum.

21. Monitoring system according to claim 19, characterized in that the marking substance contains a fluorescent dye and the detection apparatus is adapted for in vivo detection of the fluorescence as the parameter is correlated to the presence of the marking substance in the body.

22. Monitoring system according to claim 19, characterized in that the detection apparatus comprises a sensor unit which can be carried on the body.

23. Monitoring system according to claim 19, characterized in that the detection apparatus is configured in the form of a device conventionally worn on the body.

24. Monitoring system according to claim 19, characterized in that the detection apparatus comprises a time measuring device and a memory for the storage of data concerning the detection of the marking substance.

25. Monitoring system according to claim 24, characterized in that the detection apparatus produces a warning signal if no marking substance is detectable within the body of the patient within a predetermined period of time.

26. Monitoring system according to claim 19, characterized in that the detection apparatus comprises a port for the transfer of data to an external inquiry unit.

27. Monitoring system according to claim 19, characterized in that the detection apparatus comprises a transmitter for the wireless transmission of the data to an external inquiry unit.

28. Medicine dosage form for a monitoring system according to claim 19, characterized in that the dosage form includes, in addition to an active agent, a non-toxic marking substance whose presence in the body of the patient can be measured in a non-invasive fashion using the detection apparatus.

29. System for monitoring the regular intake of a medicament by a patient, characterized in that, it includes mutually adapted system components comprising a medicine dosage form containing the medicament and a detection apparatus for non-invasive detection of a substance contained in the dosage form within the body of a patient, wherein the detection apparatus is adapted for reagent-free direct measurement of a physically measurable parameter correlated with the presence of the substance in the body of the patient and comprises determination means for determination of the time dependent change of the parameter to detect intake of the medicament,

the medicament measurably influences electromagnetic radiation irradiated into the body and the detection apparatus comprises irradiation means for the irradiation of light into the body of the patient as well as detection means for measurement of a measuring quantity of the exiting light following interaction between the electromagnetic radiation and the medicament, as a parameter correlated to the presence thereof in the body and the detection apparatus comprises irradiation means for irradiation of the light at a plurality of differing irradiation locations and/or detection means for detection of the light at a plurality of differing detection locations and the marking substance is detected on the basis of the dependence of the detected parameter on the measuring distance between an irradiation location and a detection location.

30. Monitoring system according to claim 29, characterized in that the light is in the visible or infrared range of the optical spectrum.

31. Monitoring system according to claim 29, characterized in that the marking substance contains a fluorescent dye and the detection apparatus is adapted for in vivo detection of the fluorescence as the parameter is correlated to the presence of the marking substance in the body.

32. Monitoring system according to claim 29, characterized in that the detection apparatus comprises a sensor unit which can be carried on the body.

33. Monitoring system according to claim 29, characterized in that the detection apparatus is configured in the form of a device conventionally worn on the body.

34. Monitoring system according to claim 29, characterized in that the detection apparatus comprises a time measuring device and a memory for the storage of data concerning the detection of the marking substance.

35. Monitoring system according to claim 34, characterized in that the detection apparatus produces a warning signal if no marking substance is detectable within the body of the patient within a predetermined period of time.

36. Monitoring system according to claim 29, characterized in that the detection apparatus comprises a port for the transfer of data to an external inquiry unit.

37. Monitoring system according to claim 29, characterized in that the detection apparatus comprises a transmitter for the wireless transmission of the data to an external inquiry unit.

38. Medicine dosage form for a monitoring system according to claim 29, characterized in that the dosage form includes, in addition to an active agent, a non-toxic marking substance whose presence in the body of the patient can be measured in a non-invasive fashion using the detection apparatus.

39. System for monitoring the regular intake of a medicated by a patient, characterized in that, it includes mutually adapted system components comprising a medicine dosage form containing the medicament and a detection apparatus for non-invasive detection of a substance contained in the dosage form within the body of a patient, wherein the detection apparatus is adapted for reagent-free direct measurement of a physically measurable parameter correlated with the presence of the substance in the body of the patient and comprises determination means for determination of the time dependent change of the parameter to detect intake of the medicament and the detection apparatus comprises a sensor unit which can be carried on the body.

40. System for monitoring the regular intake of a medicament by a patient, characterized in that,

it includes mutually adapted system components comprising a medicine dosage form containing the medicament and a detection apparatus for non-invasive detection of a substance contained in the dosage form within the body of a patient, wherein

the detection apparatus is adapted for reagent-free direct measurement of a physically measurable parameter correlated with the presence of the substance in the body of the patient and comprises determination means for determination of the time dependent change of the parameter to detect intake of the medicament and the device is a wrist watch.

41. System for monitoring the regular intake of a medicament by a patient, characterized in that,

it includes mutually adapted system components comprising a medicine dosage form containing the medicament and a detection apparatus for non-invasive detection of a substance contained in the dosage form within the body of a patient, wherein

the detection apparatus is adapted for reagent-free direct measurement of a physically measurable parameter correlated with the presence of the substance in the body of the patient and comprises determination means for determination of the time dependent change of the parameter to detect intake of the medicament and

the detection apparatus comprises a time measuring device and a memory for the storage of data concerning the detection of the marking substance.

42. System for monitoring the regular intake of a medicament by a patient, characterized in that,

it includes mutually adapted system components comprising a medicine dosage norm containing the medicament and a detection apparatus for non-invasive detection of a substance contained in the dosage form within the body of a patient, wherein

the detection apparatus is adapted for reagent free direct measurement of a physically measurable parameter correlated with the presence of the substance in the body of the patient and comprises determination means for determination of the time dependent change of the parameter to detect intake of the medicament and

the detection apparatus produces a warning signal if no marking substance is detectable within the body of the patient within a predetermined period of time.