Highly reliable ingestible event markers and methods for using the same

Patent metadata

Field	Value
Publication number	US-10588544-B2
Application number	US-201615050733-A
Country	US
Kind code	B2
Filing date	Feb 23, 2016
Priority date	Apr 28, 2009
Publication date	Mar 17, 2020
Grant date	Mar 17, 2020

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.

First claim

What is claimed is:

1. An ingestible event marker comprising:
a support comprising a first external surface and a second external surface;
a control circuit in contact with the support to control the event marker;
a first electrochemical material in contact with the support and electrically coupled to the control circuit, wherein the first electrochemical material is positioned on the first external surface;
a second electrochemical material electrically coupled to the control circuit and in contact with the support at a location different from the location of the first material, wherein the second electrochemical material is positioned on the second external surface, wherein positioning the first electrochemical material on the first external surface and the second electrochemical material on the second external surface is configured to electrically isolate the first and second electrochemical materials from each other, and wherein the first electrochemical material is dissimilar from the second electrochemical material; and
a membrane physically associated with the support and positioned between the first electrochemical material and the second electrochemical material, wherein the membrane comprises an electrically insulative material, wherein the first electrochemical material, the second electrochemical material, and the membrane are configured to produce a dipole having a predefined dipole length based on the membrane, and wherein the membrane defines a concave shape configuration configured to prevent adherence of at least one of the first external surface and the second external surface to a target site; and
wherein the control circuit is configured to generate a signal along a current path that employs a body as an electrically conductive medium upon the application of a voltage potential to the control circuit.

2. The ingestible event marker of claim 1 , where the signal transmitted by the control circuit comprises pharmacologic information, physiologic information, or a combination thereof.

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

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

5. The ingestible event marker of claim 4 , wherein the at least one deployable element comprises a plurality of arms, and wherein each of the plurality of arms defines a first configuration and a second configuration.

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

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

8. The ingestible event marker of claim 1 , wherein the electrically insulative material is coupled to a metallic layer.

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

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

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

12. The ingestible event marker of claim 11 , wherein the active agent is physically associated with the membrane and the membrane is configured to release the active agent in a phased manner.

13. The ingestible event marker of claim 11 , wherein the active agent is comprised within at least one fluid passageway.

14. The ingestible event marker of claim 1 , 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.

15. An ingestible event marker comprising:
a support comprising a first external surface and a second external surface;
a control circuit in contact with the support to control the event marker;
a first electrochemical material in contact with the support and electrically coupled to the control circuit, wherein the first electrochemical material is positioned on the first external surface;
a second electrochemical material electrically coupled to the control circuit and in contact with the support at a location different from the location of the first material, wherein the second electrochemical material is positioned on the second external surface, wherein positioning the first electrochemical material on the first external surface and the second electrochemical material on the second external surface is configured to electrically isolate the first and second electrochemical materials from each other, and wherein the first electrochemical material is dissimilar from the second electrochemical material; and
a membrane physically associated with the support and positioned between the first electrochemical material and the second electrochemical material, wherein the membrane comprises an electrically insulative material, wherein the first electrochemical material, the second electrochemical material, and the membrane are configured to produce a dipole having a predefined dipole length based on the membrane, and wherein the membrane comprises a weight non-centrically associated with the membrane and configured to promote movement of the ingestible event marker in a liquid; and
wherein the control circuit is configured to generate a signal along a current path that employs a body as an electrically conductive medium upon the application of a voltage potential to the control circuit.

16. A system comprising:
an active agent; and
an ingestible event marker comprising:
a support comprising a first external surface and a second external surface;
a control circuit in contact with the support to control the event marker;
a first electrochemical material in contact with the support and electrically coupled to the control circuit, wherein the first electrochemical material is positioned on the first external surface;
a second electrochemical material electrically coupled to the control circuit, wherein the second electrochemical material is in contact with the support at a location different from the location of the first material to electrically isolate the first and second electrochemical materials from each other, wherein the second electrochemical material is positioned on the second external surface, and wherein the first electrochemical material is dissimilar from the second electrochemical material; and
a membrane physically associated with the support and positioned between the first electrochemical material and the second electrochemical material, wherein the membrane comprises an electrically insulative material, and wherein the first electrochemical material, the second electrochemical material, and the membrane are configured to produce a dipole having a predefined dipole length based on the membrane, and wherein the membrane defines a concave shape configuration configured to prevent adherence of at least one of the first external surface and the second external surface to a target site; and
wherein the control circuit is configured to generate a signal along a current path that employs a body as an electrically conductive medium upon the application of a voltage potential to the control circuit.

Assignees

• Proteus Digital Health Inc

Inventors

• Hafezi Hooman
• Au-Yeung Kit Yee
• Duck Robert
• Holen Maria
• Robertson Timothy
• Costello Benedict

Classifications

• A61B5/6882 Primary

  Anchoring means · CPC title

• A61K9/0097

  Medicinal compositions released by microdevices, e.g. microelectromechanical systems [MEMS], microdevices comprising chips or microdevices on silicon · CPC title

• A61B5/14539

  for measuring pH · CPC title

• A61B5/073 Primary

  Intestinal transmitters · CPC title

• A61B5/6861

  Capsules, e.g. for swallowing or implanting · CPC title