Device for Controlled Release of Chemical Molecules

• US 20080262478A1
• Filed: 12/12/2006
• Published: 10/23/2008
• 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: Langereis, Geert, Van Bruggen, Michel Paul Barbara, Krijnsen, Hendrika Cecilia, Iordanov, Ventzeslav Petrov
• Granted Patent: US 8,062,287 B2
• Time in Patent Office: Days
• 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 device for drug administration comprising

a) a measuring means which measures at least one body parameter of a patient for at least ≧

1 measuring cycle and at least ≧

1 monitoring cycle,

b) a normalizing means which generates a normalized curve for each of the measured body parameter(s) of the patient from data obtained in the measuring cycles and adjusts data obtained in the at least one monitoring cycle to normalized data based on the normalized curve so as to obtain normalized monitoring data, and

c) an ingestible capsule which comprises a drug release means which starts a drug release program, the program being started when during the at least ≧

1 monitoring cycle, a change of ≧

25%/hour on a normalized scale has been observed in the normalized monitoring data for a period of ≧

1 hour and/or the normalized monitoring data deviates from a preselected point on the normalized curve by more than at least a threshold value of ≦

50% on a normalized scale.

2. The device according to claim 1, wherein the at least one body parameter includes 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 drug release means starts a drug release program when during the at least ≧

1 monitoring cycle a change of ≧

40%/hour on the normalized scale has been observed in the normalized monitoring data for a period of ≧

3 hours.

4. The device according to claim 1, wherein the drug release means starts a drug release program when during the at least ≧

1 monitoring cycle the normalized monitoring data deviates from the minimum point of the normalized curve by a threshold value of ≦

25%.

5. The device according to claim 1, wherein the drug release means starts a drug release program when during the at least ≧

1 monitoring cycle the normalized monitoring data deviates from the maximum point of the normalized curve by a threshold value of ≦

25%.

6. The device according to claim 1, wherein the drug release program includes a delay of ≧

0 and ≦

2 measuring and/or monitoring cycles prior to the release of drugs.

7. The device according to claim 1, wherein the drug release program includes a delay of ≧

0 and ≦

24 h prior to the release of drugs.

8. The device according to claim 1, wherein the drug release program is stopped after ≧

1 and ≦

30 cycles and/or when the normalized monitoring data return to between ≧

−

60% and ≦

60%.

10. The device according to claim 1, wherein the device is incorporated in medical devices for the administration of drugs or is incorporated in medical devices for the treatment of chronic diseases:

9. A method for the controlled release of drugs, comprising the steps of

a) measuring at least one body parameter of the patient for at least ≧

3 measuring cycles and at least ≧

1 monitoring cycle,

b) generating a normalized curve for each of the measured body parameter(s) of the patient from data obtained in the measuring cycles and adjusting data obtained in the at least one monitoring cycle to normalized data based on the normalized curve so as to obtain normalized monitoring data, and

c) starting a drug release program when during the at least ≧

1 monitoring cycle a change of ≧

25% has been observed in the normalized monitoring data for a period of one hour and/or the normalized monitoring data deviates from a preselected point of the normalized curve by a threshold value of ≦

50%.