Ingestible event marker systems

• US 8,858,432 B2
• Filed: 02/01/2008
• Issued: 10/14/2014
• 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: Robertson, Timothy, Savage, George, Zdeblick, Mark, Behzadi, Yashar, Costello, Benedict, Frank, Jeremy, Hafezi, Hooman, Haniff, Tariq, O'Reilly, David
• Primary Examiner(s): Thomson, Bill
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US12/524,837
• Publication Number:
  US 20100185055A1
• Time in Patent Office: 2,447 Days
• Field of Search: 429/401, 429/405, 429/406, 429/428, 429431-432, 429523-535, 429 61- 63, 429 90- 93, 429118-119, 429121-122, 429124-147, 429163-187, 429208-214, 429219-231, 429247-255, 128920-925, 128300-301, 128/309, 128/327, 128/361, 128/372, 128/101, 128/117, 600300-301, 600/309, 600/327, 600/361, 600/372, 600/101, 600/117
• US Class Current: 600/300
• 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 (IEM) composition configured to emit a signal upon contact with a target physiological site and does not include an active agent;

wherein the IEM comprises;

a first battery structure comprising;

a first cathode;

a first anode, wherein the first cathode and the first anode are made at least in part from dissimilar materials selected to provide a voltage potential difference when the first cathode and the first anode contact an electrolyte made up at least in part by fluid present at the target physiological site;

a first chamber containing the first cathode and the first anode, wherein the first chamber defines at least one opening providing for entry and exit from the first chamber of the fluid; and

a second battery structure comprising;

a second cathode;

a second anode, wherein the second cathode and the second anode are made from dissimilar materials selected to provide a voltage potential difference when the second cathode and the second anode contact the electrolyte; and

a second chamber containing the second cathode and the second anode, wherein the second chamber defines at least one opening providing for entry and exit from the second chamber of the fluid; and

a signal receiver configured to receive a signal produced by the IEM, wherein the 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 the IEM composition comprises an integrated circuit that includes a signal generation element.

3. The system according to claim 2, wherein the IEM composition further comprises a solid support that includes the integrated circuit, and wherein the first and second battery structures are present on a surface of the solid support.

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

5. The system according to claim 1, wherein the signal receiver comprises two electrodes.

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

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

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

9. The system according to claim 8, wherein the physiological sensor is configured to provide data selected from the group consisting of respiration, heart rate, temperature and blood pressure.

10. The system according to claim 1, wherein the signal receiver comprises:

first and second electrodes configured to receive a signal;

a signal demodulator;

a signal transmitter;

a data storage element; and

a power source.

11. The system according to claim 10, wherein the signal receiver comprises an integrated circuit that comprises at least one of the elements selected from the group consisting of:

the first and second electrodes configured to receive a signal;

the signal demodulator;

the signal transmitter; and

the data storage element.

12. The system according to claim 11, wherein the signal receiver further comprises a clock element.

13. The system according to claim 12, wherein the signal receiver further comprises a preamplifier.

14. The system according to claim 13, wherein the signal receiver further comprises a microprocessor.

15. The system according to claim 10, wherein the first and second electrodes are configured to receive a signal and to sense a biomarker.

16. The system according to claim 15, wherein the biomarker is selected from the group consisting of electrocardiogram, heart rate, respiration rate and fluid status.

17. The system according to claim 15, wherein the signal receiver further comprises a physiological sensor distinct from the first and second electrodes.

18. The system according to claim 17, wherein the physiological sensor distinct from the first and second electrodes is selected from the group consisting of temperature sensor, pressure sensor and analyte detector, motion sensor or a strain gauge.

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

20. The system according to claim 19, wherein the 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.

21. The system according to claim 20, wherein the external data receiver is selected from the group consisting of a bedside monitor, a PDA, a cell phone and a PC.

22. An ingestible event marker (IEM) composition configured to emit a signal upon contact with a target physiological site and does not include an active agent, wherein the IEM comprises:

a first battery structure comprising;

a first cathode;

a first anode, wherein the first cathode and the first anode are made at least in part from dissimilar materials selected to provide a voltage potential difference when the first cathode and the first anode contact an electrolyte made up at least in part by fluid present at the target physiological site;

a first chamber containing the first cathode and the first anode, wherein the first chamber defines at least one opening providing for entry and exit from the first chamber of the fluid; and

a second battery structure comprising;

a second cathode;

a second anode, wherein the second cathode and the second anode are made from dissimilar materials selected to provide a voltage potential difference when the second cathode and the second anode contact the electrolyte; and

a second chamber containing the second cathode and the second anode, wherein the second chamber defines at least one opening providing for entry and exit from the second chamber of the fluid.

23. A signal receiver configured to receive a signal produced by an identifier of a pharmaceutical composition upon contact with a target physiological site and sized to be stably associated with a living subject in a manner that does not substantially impact movement of said living subject, wherein the identifier comprises:

a first battery structure comprising;

a first cathode;

a first anode, wherein the first cathode and the first anode are made at least in part from dissimilar materials selected to provide a voltage potential difference when the first cathode and the first anode contact an electrolyte made up at least in part by fluid present at the target physiological site;

a first chamber containing the first cathode and the first anode, wherein the first chamber defines at least one opening providing for entry and exit from the first chamber of the fluid; and

a second battery structure comprising;

a second cathode;

a second anode, wherein the second cathode and the second anode are made from dissimilar materials selected to provide a voltage potential difference when the second cathode and the second anode contact the electrolyte; and

a second chamber containing the second cathode and the second anode, wherein the second chamber defines at least one opening providing for entry and exit from the second chamber of the fluid.

24. A method comprising:

administering to a subject an ingestible event marker (IEM) configured to emit a signal upon contact with a target physiological site and does not include an active agent, wherein the IEM comprises;

a first battery structure comprising;

a first cathode;

a first anode, wherein the first cathode and the first anode are made at least in part from dissimilar materials selected to provide a voltage potential difference when the first cathode and the first anode contact an electrolyte made up at least in part by fluid present at the target physiological site;

a first chamber containing the first cathode and the first anode, wherein the first chamber defines at least one opening providing for entry and exit from the first chamber of the fluid; and

a second battery structure comprising;

a second cathode;

a second anode, wherein the second cathode and the second anode are made from dissimilar materials selected to provide a voltage potential difference when the second cathode and the second anode contact the electrolyte; and

a second chamber containing the second cathode and the second anode, wherein the second chamber defines at least one opening providing for entry and exit from the chamber of the fluid; and

detecting a signal emitted from said identifier with a signal receiver.

25. A kit comprising:

an ingestible event marker (IEM) configured to emit a signal upon contact with a target physiological site and does not include an active agent, wherein the IEM comprises;

a first battery structure comprising;

a first cathode;

a first anode, wherein the first cathode and the first anode are made at least in part from dissimilar materials selected to provide a voltage potential difference when the first cathode and the first anode contact an electrolyte made up at least in part by fluid present at the target physiological site;

a first chamber containing the first cathode and the first anode, wherein the first chamber defines at least one opening providing for entry and exit from the first chamber of the fluid; and

a second battery structure comprising;

a second cathode;

a second anode, wherein the second cathode and the second anode are made from dissimilar materials selected to provide a voltage potential difference when the second cathode and the second anode contact the electrolyte; and

a second chamber containing the second cathode and the second anode, wherein the second chamber defines at least one opening providing for entry and exit from the chamber of the fluid; and

a signal receiver.