Communication system with partial power source

• US 10,542,909 B2
• Filed: 03/30/2017
• Issued: 01/28/2020
• Est. Priority Date: 04/28/2005
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Zdeblick, Mark, Robertson, Timothy, Pikelny, Aleksandr, Hafezi, Hooman
• Primary Examiner(s): Wilson, Brian
• Application Number:
  US15/474,811
• Publication Number:
  US 20170265813A1
• Time in Patent Office: 1,034 Days
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0462 Apparatus with built-in sensors
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61J 3/007 Marking tablets or the like apparatus for printing on tablets or the like B41F17/36
• CPC Class Codes: G06K 7/10168 the powering being adversely affected by environmental influences, e.g. unwanted energy loss in the interrogation signal due to metallic or capacitive objects in the proximity of the interrogation device or in the proximity of the interrogated record carrier
• CPC Class Codes: G06K 7/10366 the interrogation device being adapted for miscellaneous applications
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: H01Q 1/273 Adaptation for carrying or wearing by persons or animals
• CPC Class Codes: H04B 13/005 Transmission systems in which the medium consists of the human body
• CPC Class Codes: H04W 4/80 : Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
• CPC Class Codes: Y10T 29/49117 : Conductor or circuit manufacturing

Abstract

The system of the present invention includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, a voltage potential is created and the power source is completed, which activates the system. The electronic component controls the conductance between the dissimilar materials to produce a unique current signature. The system can be used in a variety of different applications, including as components of ingestible identifiers, such as may be found in ingestible event markers, e.g., pharma-informatics enabled pharmaceutical compositions.

Claims

1. A composition, comprising:

a pharmaceutical product comprising a pharmaceutically acceptable carrier; and

an ingestible event marker coupled to the pharmaceutical product, wherein the ingestible event marker comprises;

a control device; and

a partial power source comprising first and second electrodes formed of dissimilar electrochemical materials configured to contact a conductive fluid and generate a voltage to energize the ingestible event marker;

wherein the control device of the energized ingestible event marker is configured to modulate current flow through the conductive fluid, the modulated current flow defining a unique current signature associated with the ingestible event marker;

wherein the ingestible event marker of the composition is;

coated with an external layer configured to delay activation of the ingestible event marker for a first period of time; and

positioned inside the pharmaceutically acceptable carrier, relative to a perimeter defined by the pharmaceutically acceptable carrier, to delay activation of the ingestible event marker for a second period of time, wherein the ingestible event marker is positioned proximate to the perimeter or proximate to a center of the pharmaceutically acceptable carrier based on an identity of the pharmaceutical product.

2. The composition according to claim 1, wherein the external layer comprises a homogeneous layer of a single material.

3. The composition according to claim 1, wherein the external layer comprises two or more distinct materials.

4. The composition according to claim 3, wherein the two or more distinct materials are present as a multilayer structure.

5. The composition according to claim 1, wherein the external layer is configured to provide conductive fluid passage through the external layer after contact of the composition with the conductive fluid.

6. The composition according to claim 1, wherein the external layer is further configured to protect the ingestible event marker in a dicing process.

7. The composition according to claim 1, wherein the external layer is configured to dissolve in five or more minutes after being in contact with the conducting fluid.

8. The composition according to claim 1, wherein the external layer is environmentally sensitive.

9. The composition according to claim 8, wherein the external layer is temperature sensitive.

10. The composition according to claim 8, wherein the external layer is pH sensitive.

11. The composition according to claim 10, wherein the external layer is insoluble at a first pH and soluble at a second pH.

12. The composition according to claim 1, wherein the ingestible event marker is secured inside the pharmaceutically acceptable carrier.

13. The composition according to claim 1, wherein the first and second electrodes of the ingestible event marker are coated with the external layer.

14. The composition according to claim 1, wherein the pharmaceutical product further comprises a pharmaceutical material, and wherein the external layer is further configured to prevent the ingestible event marker from being activated by the pharmaceutical material.

15. The composition according to claim 1, wherein the ingestible event marker is positioned proximate to the perimeter or proximate to the center of the pharmaceutically acceptable carrier further based on a desired activation delay between a time of initial ingestion and activation of the ingestible event marker.

16. A composition, comprising:

a pharmaceutical product comprising a pharmaceutically acceptable carrier; and

an ingestible event marker positioned inside the pharmaceutical product, wherein the ingestible event marker comprises;

a partial power source comprising first and second electrodes formed of dissimilar electrochemical materials, wherein the partial power source is configured to generate a voltage to energize the ingestible event marker upon contact with a conductive fluid; and

a control device configured to modulate current flow through the conductive fluid, wherein the modulated current flow defines a unique current signature;

wherein the ingestible event marker of the composition is;

coated with an external layer configured to at least one of delay activation of the ingestible event marker or protect the ingestible event marker; and

positioned relative to a perimeter defined by the pharmaceutically acceptable carrier to delay activation of the ingestible event marker, wherein the ingestible event marker is positioned proximate to the perimeter or proximate to a center of the pharmaceutically acceptable carrier based on an identity of the pharmaceutical product.

17. The composition according to claim 16, wherein the first and second electrodes of the ingestible event marker are coated with the external layer.

18. The composition according to claim 16, wherein the external layer is environmentally sensitive.