Highly reliable ingestible event markers and methods for using the same

• US 10,588,544 B2
• Filed: 02/23/2016
• Issued: 03/17/2020
• 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, Kit Yee, Duck, Robert, Holen, Maria, Robertson, Timothy, Costello, Benedict
• Primary Examiner(s): Clow, Lori A.
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US15/050,733
• Publication Number:
  US 20170014046A1
• Time in Patent Office: 1,484 Days
• Field of Search: None
• 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 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.