HIGHLY RELIABLE INGESTIBLE EVENT MARKERS AND METHODS FOR USING THE SAME

• US 20110054265A1
• Filed: 04/27/2010
• Published: 03/03/2011
• 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: Holen, Maria, Duck, Robert, Au-Yeung, Kityee, Hafezi, Hooman, Costello, Benedict, Robertson, Timothy
• Granted Patent: US 8,545,402 B2
• Time in Patent Office: Days
• 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. A highly reliable event marker comprising:

a support;

a control circuit physically associated with the support to control the highly reliable event marker;

a first electrochemical material physically associated with the support and electrically coupled to the control circuit;

a second electrochemical material electrically coupled to the control circuit and physically associated with the support at a location different from the location of the first material, such that the first and second electrochemical materials are electrically isolated from each other; and

a membrane physically associated to the support and positioned relative to the first electrochemical and second electrochemical materials to generate a virtual dipole length larger than an actual dipole length defined by the first and the second electrochemical materials.

2. The highly reliable event marker of claim 1 wherein the control circuit controls the voltage between the first material and the second electrochemical materials.

3. The highly reliable ingestible event marker according to claim 1 wherein the first and the second electrochemical materials are selected 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 highly reliable ingestible event marker according to claim 1 wherein the membrane is a planar structure having an outer edge that extends beyond the edge of the first and second electrochemical materials.

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

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

7. The highly reliable 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 having a weight equal or greater to 90% of the overall weight of the highly reliable event marker.

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

9. The highly reliable ingestible event marker of claim 1 further comprising a weight non-centrically associated with the membrane.

10. The highly reliable ingestible event marker of claim 1 further comprising adding a water-swellable component non-centrically associated with the membrane.

11. The highly reliable ingestible event marker according to claim 1, wherein the highly reliable event marker is physically associated with an active agent.

12. The highly reliable ingestible event marker according to claim 11, wherein the active agent is physically associated with the membrane.

13. The highly reliable ingestible event marker according to claim 11, wherein the membrane releases the active agent in a phased manner.

14. The highly reliable ingestible event marker according to claim 11, wherein the active agent comprises at least one fluid passageway.

15. A system comprising:

a highly reliable ingestible event marker comprising;

a support;

a control circuit physically associated with the support to control the highly reliable event marker;

a first electrochemical material physically associated with the support and electrically coupled to the control circuit;

a second electrochemical material electrically coupled to the control circuit and physically associated with the support at a location different from the location of the first material, such that the first and second electrochemical materials are electrically isolated from each other; and

a membrane physically associated to the support and positioned relative to the first electrochemical and second electrochemical materials to generate a virtual dipole length larger than an actual dipole length defined by the first and the second electrochemical materials.

16. The system of claim 15 wherein the highly reliable ingestible event marker is associated with an active agent.

17. The system of claim 15 wherein the active agent is physically associated with the membrane.

18. The system of claim 15 wherein the highly reliable event marker further comprising 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 highly reliable event marker.

19. The system of claim 15 wherein the membrane is a planar structure having an outer edge that extends beyond the edge of the first and second electrochemical materials.

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