Highly reliable ingestible event markers and methods for using the same

• US 8,545,402 B2
• Filed: 04/27/2010
• Issued: 10/01/2013
• Est. Priority Date: 04/28/2009
• Status: Active Grant

• Current Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Hafezi, Hooman, Au-Yeung, Kityee, Duck, Robert, Holen, Maria, Robertson, Timothy, Costello, Benedict
• Primary Examiner(s): Thomson, Bill
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US12/744,642
• Publication Number:
  US 20110054265A1
• Time in Patent Office: 1,253 Days
• Field of Search: 977700-963, 361271-330, 361500-541, 361/437, 600300-301
• US Class Current: 600/300
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: H01M 50/138 adapted for specific cells, e.g. electrochemical cells operating at high temperature
• CPC Class Codes: H01M 50/40 Separators; Membranes; Diaphragms; Spacing elements inside cells
• CPC Class Codes: H01M 6/34 Immersion cells, e.g. sea-water cells

Abstract

Ingestible event markers having high reliability are provided. Aspects of the ingestible event markers include a support, a control circuit, a first electrochemical material, a second electrochemical material and a membrane. In addition, the ingestible event markers may include one or more components that impart high reliability to the ingestible event marker. Further, the ingestible event markers may include an active agent. In some aspects, the active agent, such as a pharmaceutically active agent or a diagnostic agent may be associated with the membrane.

Claims

1. An ingestible event marker comprising:

a circuitry element comprising;

a control circuit comprising an upper surface and a lower surface;

a first electrochemical material defining a first outer perimeter edge, the first electrochemical material electrically coupled to the upper surface of the control circuit; and

a second electrochemical material defining a second outer perimeter edge, the second electrochemical material electrically coupled to the lower surface of the control circuit, wherein the first and second electrochemical materials are electrically isolated from each other;

a membrane positioned between the first and second electrochemical materials comprising a signal amplification element comprising an insulating material positioned between the first and second electrochemical materials, the insulating material dimensioned to increase a length of the current path through conducting liquid in a body between the first and second electrochemical materials forming channels for the conducting fluid thereby boosting the conductance path therebetween, wherein the insulating material comprises a third outer edge extending beyond the first and second outer perimeter edges of the respective first and second electrochemical materials;

wherein the first and second active electrode materials are configured to provide a voltage potential difference to the control circuit as a result of the first and second materials being in contact with the conducting liquid within the body; and

wherein upon application of the voltage potential to the control circuit, the circuitry element generates a conductively transmitted signal comprising the current path that employs the body as a conduction medium such that the signal is conducted between the circuitry element and a receiver through the body tissues.

2. The ingestible event marker of claim 1 wherein the control circuit is electrically coupled to the first and second electrochemical materials, wherein the control circuit is configured to control a voltage potential difference between the first and second electrochemical materials.

3. The ingestible event marker according to claim 1 wherein the first and second electrochemical materials are configured to provide a voltage potential difference when in contact with a conducting liquid at a target physiological site, wherein the potential difference provides power for communication.

4. The ingestible event marker according to claim 1 wherein the membrane is a planar structure.

5. The ingestible event marker according to claim 1 wherein the membrane comprises at least one of multiple coatings and multiple layers.

6. The ingestible event marker of claim 1 further comprising at least one controlled activation element.

7. The ingestible event marker of claim 1 further comprising at least one of a non-active agent salt, an anti-foaming agent, a micro-environment modification agent and a soluble component comprising a weight equal or greater to 90% of the overall weight of the event marker.

8. The ingestible event marker according to claim 1 wherein the membrane comprises at least one of opposing curved edges, one or more projections, or one or more deployable elements.

9. The ingestible event marker of claim 1 further comprising a weight non-centrically positioned on the membrane.

10. The ingestible event marker of claim 1 further comprising a water-swellable component non-centrically positioned on the membrane.

11. The ingestible event marker according to claim 1, wherein the event marker comprises an active agent.

12. The ingestible event marker according to claim 11, wherein the membrane comprises the active agent.

13. The ingestible event marker according to claim 11, wherein the membrane is configured to controllably release the active agent.

14. The ingestible event marker according to claim 1, further comprising a solid component having a tablet configuration, wherein the tablet comprises at least one fluid passageway.

15. A system comprising:

an ingestible event marker comprising;

a circuitry element comprising;

a control circuit comprising an upper surface and a lower surface;

a first electrochemical material defining a first outer perimeter edge,

the first electrochemical material electrically coupled to the upper surface of the control circuit; and

a second electrochemical material defining a second outer perimeter edge, the second electrochemical material electrically coupled to the lower surface of the control circuit, wherein the first and second electrochemical materials are electrically isolated from each other;

a membrane positioned between the first and second electrochemical materials comprising a signal amplification element comprising an insulating material positioned between the first and second electrochemical materials, the insulating material dimensioned to increase a length of the current path through conducting liquid in a body between the first and second electrochemical materials forming channels for the conducting fluid thereby boosting the conductance path therebetween, wherein the insulating material comprises a third outer edge extending beyond the first and second outer perimeter edges of the respective first and second electrochemical materials

wherein the first and second active electrode materials are configured to provide a voltage potential difference to the control circuit as a result of the first and second materials being in contact with the conducting liquid within the body; and

wherein upon application of the voltage potential to the control circuit, the circuitry element generates a conductively transmitted signal comprising the current path that employs the body as a conduction medium such that the signal is conducted between the circuitry element and a receiver through the body tissues.

16. The system of claim 15 wherein the ingestible event marker comprises an active agent.

17. The system of claim 15 wherein the active agent is located on the membrane.

18. The system of claim 15 wherein the event marker further comprises at least one of a non-active agent salt, an anti-foaming agent, a micro-environment modification agent and a soluble component having a weight equal or greater to 90% of the overall weight of the event marker.

19. The system of claim 15 wherein the membrane is a planar structure.

20. The system of claim 15 wherein the membrane comprises at least one of opposing curved edges, one or more projections, or one or more deployable elements.