Pharma-informatics system

• US 8,847,766 B2
• Filed: 04/28/2006
• Issued: 09/30/2014
• Est. Priority Date: 04/28/2005
• Status: Active Grant

• Current Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Zdeblick, Mark, Thompson, Andrew, Pikelny, Aleksandr, Robertson, Timothy, Hafezi, Hooman
• Primary Examiner(s): HOLLOWAY III, EDWIN C
• Application Number:
  US11/912,475
• Publication Number:
  US 20080284599A1
• Time in Patent Office: 3,077 Days
• Field of Search: 340/10.1, 340/539.12, 340/573.1, 340/572.1, 340/572.7, 340/572.8, 600/302, 604/890.01
• US Class Current: 340/573.1
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0462 Apparatus with built-in sensors
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61J 3/007 Marking tablets or the like apparatus for printing on tablets or the like B41F17/36
• CPC Class Codes: G06K 7/10168 the powering being adversely affected by environmental influences, e.g. unwanted energy loss in the interrogation signal due to metallic or capacitive objects in the proximity of the interrogation device or in the proximity of the interrogated record carrier
• CPC Class Codes: G06K 7/10366 the interrogation device being adapted for miscellaneous applications
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: H01Q 1/273 Adaptation for carrying or wearing by persons or animals
• CPC Class Codes: H04B 13/005 Transmission systems in which the medium consists of the human body
• CPC Class Codes: H04W 4/80 : Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
• CPC Class Codes: Y10T 29/49117 : Conductor or circuit manufacturing

Abstract

Compositions, systems and methods that allow for the detection of the actual physical delivery of a pharmaceutical agent to a body are provided. Embodiments of the compositions include an identifier and an active agent. The invention finds use in a variety of different applications, including but not limited to, monitoring of therapeutic regimen compliance, tracking the history of pharmaceutical agents, etc.

Claims

1. A composition comprising:

an active agent;

an identifier that transmits a conductive signal, wherein the conductive signal transmitted by the identifier is substantially confined to a body comprising a bodily fluid;

a pharmaceutically acceptable carrier; and

a power source that is activated upon contact with the bodily fluid, wherein said power source comprises;

first and second consumable electrodes formed of dissimilar materials, wherein the first and second consumable electrodes are configured to both generate a voltage to energize the identifier and transmit the conductive signal to the body when the first and second electrodes contact the bodily fluid; and

wherein said composition is disrupted upon administration to a subject.

2. The composition according to claim 1, wherein the conductive signal is a generic signal.

3. The composition according to claim 1, wherein the conductive signal is a unique conductive signal.

4. The composition according to claim 3, wherein the unique conductive signal is a coded signal.

5. The composition according to claim 1, wherein the conductive signal is a constant signal.

6. The composition according to claim 1, wherein the composition generates an intermittent conductive signal.

7. The composition according to claim 1, wherein the conductive signal is a modulated signal.

8. The composition according to claim 7, wherein the modulated signal is modulated in at least one of amplitude, frequency and phase.

9. The composition according to claim 8, wherein the conductive signal is a frequency modulated signal.

10. The composition according to claim 8, wherein the conductive signal is an amplitude modulated signal.

11. The composition according to claim 8, wherein the conductive signal is a phase modulated signal.

12. The composition according to claim 1, wherein the identifier comprises an activator and a conductive signal generation element, wherein the activator activates the signal generation element to emit the conductive signal.

13. The composition according to claim 12, wherein the activator comprises the power source that is turned on upon contact with the bodily fluid.

14. The composition according to claim 12, wherein the conductive signal generation element comprises control logic.

15. The composition according to claim 12, wherein the conductive signal generation element comprises an oscillator.

16. The composition according to claim 12, wherein the conductive signal generation element comprises a signal transmitter.

17. The composition according to claim 16, wherein the signal transmitter comprises at least one of the first and second electrode.

18. The composition according to claim 1, wherein the active agent is a cardiovascular agent.

19. The composition according to claim 1, wherein the composition is a solid.

20. The composition according to claim 19, wherein the composition is a tablet.

21. A system comprising:

(a) a composition according to claim 1; and

(b) a receiver for detecting a signal produced by the identifier.

22. The system according to claim 21, wherein the receiver is an in vivo receiver.

23. The system according to claim 21, wherein the receiver is an ex vivo receiver.

26. The composition of claim 1, wherein the conductive signal is transmitted at frequencies in the order of 100 kHz.

27. the composition of claim 1, wherein the first and second consumable electrodes formed of dissimilar metals constitute a pre-battery, wherein the pre-battery is completed when the first and second consumable electrodes contact the bodily fluid upon administration of the composition to a subject.

24. A method comprising a composition disposed within a body, the composition comprising an active agent, an identifier, a pharmaceutically acceptable carrier, and a power source comprising first and second consumable electrodes formed of dissimilar materials configured to both generate a voltage to energize the identifier and transmit the conductive signal to the body, the method comprising:

transmitting by the identifier a conductive signal substantially confined to the body;

disrupting the composition upon administration to a subject, to obtain data for the composition;

generating a voltage to energize the identifier when the power source contacts a bodily fluid by consuming the first and second electrodes;

transmitting the conductive signal substantially confined to the body when the first and second electrodes contact the bodily fluid and are consumed by the bodily fluid; and

determining historical information for the composition from said data.

25. The method according to claim 24, comprising determining the identity of the last known purchaser of the composition from said historical information.