Device for controlled release of chemical molecules

• US 8,062,287 B2
• Filed: 12/12/2006
• Issued: 11/22/2011
• Est. Priority Date: 12/22/2005
• Status: Active Grant

• Current Assignee: Biora Therapeutics Incorporated
• Original Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Inventors: Krijnsen, Hendrika Cecilia, Iordanov, Ventzeslav Petrov, Langereis, Geert, Van Bruggen, Michel Paul Barbara
• Primary Examiner(s): Mehta; Bhisma
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US12/158,059
• Publication Number:
  US 20080262478A1
• Time in Patent Office: 1,806 Days
• Field of Search: 604/31, 604 65- 67, 604/503, 604/890.1, 604/891.1
• US Class Current: 604/890.1
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

The invention relates to a device comprising an ingestible capsule which measures at least one body parameter and starts a drug release program upon predefined changes in the body parameter.

Claims

1. A medical device for drug administration comprising:

a) a device which measures at least one body parameter of a patient for at least one measuring cycle and at least one monitoring cycle,

b) a central control unit programmed to generate a normalized curve for each of the at least one measured body parameter of the patient from measured data obtained in the at least one measuring cycle and to adjust the measured data obtained in the at least one monitoring cycle to normalize the measured data based on the normalized curve to generate normalized monitoring data, and

c) an ingestible capsule which starts releasing the drug in response to a change of at least 25%/hour on a normalized scale being observed in the normalized monitoring data for a period of at least 1 hour.

2. The device according to claim 1, wherein the at least one body parameter includes at least one of body temperature, core body temperature, skin surface temperature, blood pressure, melatonin level, triacylglycerol level, and cortisol level.

3. The device according to claim 1, wherein the central control unit controls the ingestible capsule to start releasing the drug during the at least one monitoring cycle in response to a change of at least 40%/hour on the normalized scale being observed in the normalized monitoring data for a period of at least 3 hours.

4. The device according to claim 1, wherein the central control unit controls the ingestible capsule to start releasing the drug during the at least one monitoring cycle in response to the normalized monitoring data deviating from a minimum point of the normalized curve by a threshold value of at most 25%.

5. The device according to claim 1, wherein the central control unit controls the ingestible capsule to start releasing the drug during the at least one monitoring cycle in response to the normalized monitoring data deviating from a maximum point of the normalized curve by a threshold value of at most 25%.

6. The device according to claim 1, wherein the central control unit controls the ingestible capsule to delay releasing of the drug for at most 2 measuring and/or monitoring cycles.

7. The device according to claim 1, wherein the central control unit controls the ingestible capsule to delay releasing of the drug for between 1 and 24 hours.

8. The device according to claim 1, wherein the central control unit controls the ingestible capsule to stop releasing the drug after one of:

at most 30 cycles and

when the normalized monitoring data return to between at least −

60% and at most 60% of the preselected point of the normalized curve.

9. The device according to claim 1, wherein the drug is also released in response to the normalized monitoring data deviating from a preselected point on the normalized curve by more than a threshold value of at most 50% on a normalized scale.

10. A method for the controlled release of drugs from a capsule, comprising:

a) measuring at least one body parameter of a patient for at least 3 measuring cycles and at least one monitoring cycle,

b) generating a normalized curve for the measured body parameter of the patient;

c) adjusting the measured body parameter obtained in the at least one monitoring cycle to normalize the measured body parameter based on the normalized curve to generate normalized monitoring data, and

d) starting to release a drug during the at least one monitoring cycle in response to at least observing a change of at least 25% in the normalized measured body parameter for a period of one hour.

11. The method according to claim 10, wherein the measured body parameter includes at least one of body temperature, core body temperature, skin surface temperature, blood pressure, melatonin level, triacylglycerol level, and cortisol level.

12. The method according to claim 10, further comprising:

starting the drug release program in response to observing a change of at least 40%/hour in the normalized measured body parameter for a period of at least 3 hours.

13. The method according to claim 10, further comprising:

starting the drug release program in response to the normalized measured body parameter deviating from a minimum point of the normalized curve by a threshold value of at most 25%.

14. The method according to claim 10, further including:

stopping release of the drug based on a rate of change in the normalized measured body parameter.

15. The method according to claim 10, further including:

delaying starting to release the drug by at least 1 hour.

16. The method according to claim 10, further including:

stopping release of the drug after at most 30 cycles or when the normalized measured body parameter returns to between −

60% and 60% of the preselected point on the normalized curve.

17. The method according to claim 10, wherein the release of the drug is started in response to the normalized measured body parameter deviating from a preselected point of the normalized curve by a preselected percentage.

18. A drug administration device comprising:

an ingestible capsule;

a parameter monitor disposed in the ingestible capsule to measure at least one body parameter of a patient who has ingested the ingestible capsule;

a drug storage container disposed in the ingestible capsule which stores drugs;

a valve which is controllable to release the drugs in the drug storage container from the ingestible capsule; and

a control unit disposed in the ingestible capsule, the control unit receiving measured body parameter data from the parameter monitor, generating a normalized curve from the measured body parameter data over a plurality of monitoring cycles, normalizing the measured body parameter data, and controlling the valve to release the drugs in response at least to the normalized measured body parameter changing at a preselected rate for a preselected duration.

19. The device according to claim 18, wherein the control unit further controls the valve to release the drugs in response to the normalized body parameter deviating from a selected point on the normalized curve by a preselected threshold value.