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Last Updated: April 24, 2024

Claims for Patent: 9,320,455


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Summary for Patent: 9,320,455
Title:Highly reliable ingestible event markers and methods for using the same
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.
Inventor(s): Hafezi; Hooman (Redwood City, CA), Au-Yeung; Kityee (San Francisco, CA), Duck; Robert (San Francisco, CA), Holen; Maria Casillas (Santa Clara, CA), Robertson; Timothy (Belmont, CA), Costello; Benedict James (Berkeley, CA)
Assignee: Proteus Digital Health, Inc. (Redwood City, CA)
Application Number:13/756,280
Patent Claims: 1. An ingestible event marker comprising: a support; a control circuit physically associated with the support to control the 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, wherein the first electrochemical material is dissimilar from the second electrochemical material, and wherein the first and second electrochemical materials are configured to produce an actual dipole having a predefined dipole length, wherein the actual dipole length is a distance between the first electrochemical material and the second electrochemical material; and a membrane physically associated with the support and positioned between the first electrochemical material and the second electrochemical material to produce a virtual dipole having a length defined by a distance across the membrane, wherein the virtual dipole length is larger than the actual dipole length; and wherein the first and the second electrochemical materials are configured to generate a voltage potential to power the control circuit when the first and the second electrochemical materials come into contact with an electrically conductive liquid at a target physiological site.

2. The ingestible event marker of claim 1, wherein upon application of the voltage potential to the control circuit, the control circuit is configured to generate a conductive signal to transmit information.

3. The ingestible event marker of claim 1, wherein the membrane defines at least one opposing curved edge.

4. The ingestible event marker of claim 1, wherein the membrane comprises at least one projection.

5. The ingestible event marker of claim 1, wherein the membrane defines a concave shape configuration.

6. The ingestible event marker of claim 1 wherein the membrane comprises at least one depolyable elements.

7. The ingestible event marker of claim 6, wherein the at least one depolyable element comprises a plurality of arms, and wherein each of the plurality of arms defines a first configuration and a second configuration.

8. The ingestible event marker of claim 1, wherein the membrane defines a planar structure defining an outer edge that extends beyond an edge defined by the first electrochemical material and an edge defined by the second electrochemical material.

9. The ingestible event marker of claim 1, wherein the membrane comprises at least one of multiple coatings and multiple layers.

10. The ingestible event marker of claim 1, wherein the membrane is a composite structure made of at least two materials.

11. The ingestible event marker of claim 10, wherein the membrane comprises an insulative material coupled to a metallic layer.

12. The ingestible event marker of claim 1, wherein the membrane comprises an electrically insulative material configured to dissolve in a predetermined amount of time when in contact with a physiological fluid.

13. The ingestible event marker of claim 1, further comprising a weight non-centrically associated with the membrane.

14. The ingestible event marker of claim 1, further comprising a water-swellable component non-centrically associated with the membrane.

15. The ingestible event marker of claim 1, further comprising an active agent.

16. The ingestible event marker of claim 15, wherein the active agent is physically associated with the membrane and the membrane is configured to release the active agent in a phased manner.

17. The ingestible event marker of claim 15, wherein the active agent comprises at least one fluid passageway.

18. A system comprising: an active agent; and an ingestible event marker comprising: a support; a control circuit physically associated with the support to control the 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, wherein the first electrochemical material is dissimilar from the second electrochemical material, and wherein the first and second electrochemical materials are configured to produce an actual dipole having a predefined dipole length, wherein the actual dipole length is a distance between the first electrochemical material and the second electrochemical material; and a membrane physically associated with the support and positioned between the first electrochemical material and the second electrochemical material to produce a virtual dipole having a length defined by the membrane, wherein the virtual dipole length is larger than the actual dipole length; and wherein the first and the second electrochemical materials are configured to generate a voltage potential to power the control circuit when the first and the second electrochemical materials come into contact with an electrically conductive liquid at a target physiological site.

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

20. The system of claim 18, wherein the membrane defines a planar structure defining an outer edge that extends beyond an edge defined by the first and second electrochemical materials and wherein the membrane comprises at least one of an opposing curved edge, a projection, or a deployable element.

21. The ingestible event marker of claim 1, wherein the membrane is dimensioned to increase a length of a current path through a conducting liquid in a body between the first and second electrochemical materials.

22. The system of claim 18, wherein the membrane is dimensioned to increase a length of a current path through a conducting liquid in a body between the first and second electrochemical materials.

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