INGESTIBLE EVENT MARKER SYSTEMS

• US 20100185055A1
• Filed: 02/01/2008
• Published: 07/22/2010
• Est. Priority Date: 02/01/2007
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Frank, Jeremy, Haniff, Tariq, Behzadi, Yashar, Savage, George, Hafezi, Hooman, Costello, Benedict, Robertson, Timothy, Zdeblick, Mark, O'Reilly, David
• Granted Patent: US 8,858,432 B2
• Time in Patent Office: Days
• US Class Current: 600/117
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• 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 5/0073 by tomography, i.e. reconstruction of 3D images from 2D projections A61B5/0066 takes precedence
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61B 5/6873 Intestine
• CPC Class Codes: A61J 3/007 Marking tablets or the like apparatus for printing on tablets or the like B41F17/36
• CPC Class Codes: G01N 27/3277 being a redox reaction, e.g. detection by cyclic voltammetry voltammetry per se G01N27/42, G01N27/48
• CPC Class Codes: H01M 6/005 Devices for making primary cells
• CPC Class Codes: H01Q 1/273 Adaptation for carrying or wearing by persons or animals
• CPC Class Codes: H04B 5/45 Transponders
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

Ingestible event marker systems that include an ingestible event marker (i.e., an IEM) and a personal signal receiver are provided. Embodiments of the IEM include an identifier, which may or may not be present in a physiologically acceptable carrier. The identifier is characterized by being activated upon contact with a target internal physiological site of a body, such as digestive tract internal target site. The personal signal receiver is configured to be associated with a physiological location, e.g., inside of or on the body, and to receive a signal the IEM. During use, the IEM broadcasts a signal which is received by the personal signal receiver.

Claims

1. A system comprising:

an ingestible event marker composition that emits a signal upon contact with a target physiological site and does not include an active agent;

a signal receiver configured to receive a signal produced by said ingestible event marker, wherein said receiver is sized to be stably associated with a living subject in a manner that does not substantially impact movement of said living subject.

2. The system according to claim 1, wherein said IEM comprises an integrated circuit that includes both a signal generation functional block and a power source functional block.

3. The system according to claim 2, wherein said power source functional block comprises first and second dissimilar electrode materials.

4. The system according to claim 3, wherein said first and second electrode materials are present on different surfaces of a solid support that includes said integrated circuit.

5. The system according to claim 1, wherein said signal receiver comprises at least one electrode.

6. The system according to claim 1, wherein said signal receiver comprises two electrodes.

7. The system according to claim 1, wherein said signal receiver further comprises a power generation element.

8. The system according to claim 1, wherein said signal receiver further comprises a data storage element.

9. The system according to claim 1, wherein said signal receiver further comprises a physiological sensor.

10. The system according to claim 9, wherein said physiological sensor is configured to provide data selected from the group consisting of:

respiration, heart rate, temperature and blood pressure.

11. The system according to claim 1, wherein said signal receiver comprises:

(i) first and second electrodes configured to receive a signal;

(ii) a signal demodulator;

(iii) a signal transmitter;

(iv) a data storage element; and

(v) a power source.

12. The system according to claim 11, wherein said signal receiver includes an integrated circuit that comprises at least one of the elements selected from the group consisting of:

(i) first and second electrodes configured to receive a signal;

(ii) a signal demodulator;

(iii) a signal transmitter; and

(iv) a data storage element.

13. The system according to claim 12, wherein said signal receiver further comprises a clock element.

14. The system according to claim 13, wherein said signal receiver further comprises a preamplifier.

15. The system according to claim 14, wherein said signal receiver further comprises a microprocessor.

16. The system according to claim 11, wherein said first and second electrodes are configured to receive a signal and to sense a biomarker.

17. The system according to claim 16, wherein said biomarker is selected from the group consisting of:

electrocardiogram, heart rate, respiration rate and fluid status.

18. The system according to claim 16, wherein said signal receiver further comprises a physiological sensor distinct from said first and second electrodes.

19. The system according to claim 18, wherein said physiological sensor distinct from said first and second electrodes is selected from the group consisting of:

temperature sensor, pressure sensor and analyte detector, motion sensor or a strain gauge.

20. The system according claim 1, wherein said system further comprises an external data receiver configured to receive data from said signal receiver.

21. The system according to claim 20, wherein said external data receiver further comprises at least one of a data storage element, a data processing element, a data display element, data transmission element, a notification mechanism, and a user interface.

22. The system according to claim 21, wherein said external data receiver is selected from the group consisting of:

a bedside monitor, a PDA, a cell phone and a PC.

23. An ingestible event marker composition that emits a signal upon contact with a target physiological site and does not include an active agent.

24-43. -43. (canceled)

44. A signal receiver configured to receive a signal produced by an identifier of a pharmaceutical composition and sized to be stably associated with a living subject in a manner that does not substantially impact movement of said living subject.

45-60. -60. (canceled)

61. A method comprising:

(a) administering to a subject an ingestible event marker that emits a signal upon contact with a target physiological site and does not include an active agent; and

(b) detecting a signal emitted from said identifier with a signal receiver.

62-70. -70. (canceled)

71. A kit comprising:

an ingestible event marker that emits a signal upon contact with a target physiological site and does not include an active agent; and

a signal receiver.

72-73. -73. (canceled)