Ingestible Circuitry

• US 20100298668A1
• Filed: 08/13/2009
• Published: 11/25/2010
• Est. Priority Date: 08/13/2008
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Hafezi, Hooman, Costello, Benedict, Snyder, Eric
• Granted Patent: US 8,540,633 B2
• Time in Patent Office: Days
• US Class Current: 600/302
• CPC Class Codes: A23P 20/20 Making of laminated, multi-layered, stuffed or hollow foodstuffs, e.g. by wrapping in preformed edible dough sheets or in edible food containers
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take 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 5/6871 Stomach
• CPC Class Codes: A61B 5/6873 Intestine
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 3/007 Marking tablets or the like apparatus for printing on tablets or the like B41F17/36
• CPC Class Codes: A61J 3/06 into the form of pills, lozenges or dragees
• 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: A61K 9/4825 Proteins, e.g. gelatin gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• CPC Class Codes: G01N 33/15 Medicinal preparations ; Physical properties thereof, e.g. dissolubility drug screening with animal cells G01N33/5008
• CPC Class Codes: H01M 6/00 Primary cells; Manufacture thereof
• CPC Class Codes: H05K 13/00 Apparatus or processes specially adapted for manufacturing or adjusting assemblages of electric components
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49108 : Electric battery cell making
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.

Abstract

The present invention provides for safe and reliable electronic circuitry that can be employed in ingestible compositions. The ingestible circuitry of the invention includes a solid support; a conductive element; and an electronic component. Each of the support, conductive element and electronic component are fabricated from an ingestible material. The ingestible circuitry finds use 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. An device comprising:

a support;

a first electrode connected to the support;

a second electrode connected to the support; and

a control circuit for controlling current flow, wherein the control circuit is secured to the support and wherein the first electrode is electrically coupled to the control circuit at a first input and the second electrode is electrically coupled to the control circuit at a second input,

wherein the first and second electrodes are made of dissimilar materials that are capable of providing a voltage potential when in contact with a conducting fluid.

2. The device of claim 1, wherein the control circuit is activated when the device contacts the conducting fluid, which causes a voltage potential between the first and second electrodes that powers the control circuit.

3. The device of claim 1 wherein the control circuit produces a unique current signature by controlling the current path created between the first and second electrode through the conducting fluid.

4. The device of claim 1 wherein the support and control circuit are ingestible and at least one of the first and second electrodes is digestible.

5. The device of claim 1, wherein the first and second electrodes are created through deposition of a digestible material onto the support.

6. The device of claim 1, further comprising:

a backing layer;

a release layer laminated on one side thereof to the backing layer;

a metallic layer positioned on one side thereof next to the release layer on a side opposite from the backing layer and laminated on the opposite side to the first electrode.

7. The device of claim 6, wherein the support defines an aperture for receiving the control circuit that is electrically coupled to the second electrode.

8. The device of claim 7, wherein electrically coupling of the first electrode to the control circuit is achieved by removing the backing layer and the release layer to expose the metallic layer and wherein the metallic layer is electrically coupled to the control circuit at the first input thereby coupling the first electrode to the control circuit at the first input.

9. The device of claim 1, wherein the control circuit and the electrodes are electrically coupled by depositing a line of conductive material between each input of the control circuit and each of the electrodes on the surface of the support.

10. The device of claim 1, wherein at least a portion of the control circuit is covered by a protective layer.

11. A method of producing an identifiable ingestible device that is operational upon contact with a conducting fluid, the method comprising the steps of:

providing a first laminate comprising an electrode and an anode to form a voltage potential there between when the ingestible device comes in contact with the conducting fluid;

defining an aperture in the first laminate for receiving a circuitry component;

fixing the circuitry component in the aperture with a conductive adhesive such that the circuitry component is electrically coupled to the electrode and the anode;

controlling current flow through the ingestible device and the conducting fluid to produce a unique current signature.

12. The method according to claim 11, wherein the first laminate further comprises an internal conductive layer.

13. The method according to claim 11, wherein the first laminate further comprises an internal virtual dipole layer.

14. A device for indicating the ingesting of a pharmaceutical product, the device comprising:

a support comprising a conductive layer including a plurality of electrically isolated sections;

a plurality of electrodes positioned on the support, each of which is deposited on the support and electrically connected to one of the plurality of electrically isolated sections of the conductive layer;

a control circuit comprising a plurality of inputs, wherein the control circuit is positioned within an aperture defined by the support such that each input is electrically coupled to one of the plurality of electrically isolated sections thereby allowing the control circuit to independently control current flow through each of the plurality of electrically isolated sections to generate a current signature that indicates the device is in contact with a conducting fluid; and

a layer of protective material for covering the control circuit wherein the protective material protects the control circuit as the control circuit is activated when the plurality of electrodes come into contact with the conductive fluid.

15. A method for producing an identifier to indicate the presence of conducting fluid, the method comprising the steps of:

laminating a non-conducting element between first and second dissimilar materials to create a support, such that the first and second dissimilar materials provide a voltage potential when in contact with the conducting fluid;

removing a portion of the first and second dissimilar materials from the perimeter of the support such that the non-conducting element is exposed to create a skirt;

securing a circuit within a hole defined by the support such that the circuit is electrically coupled to each of the dissimilar materials using a conductive adhesive; and

activating the circuit that controls the flow of current between the dissimilar materials through the conducting fluid to indicate the presence of the conducting fluid.

16. The method of claim 15 further comprising the step of creating a voltaic cell through oxidation and reduction reactions when the first and second dissimilar materials are in contact with the conducting fluid.

17. The method of claim 16 further comprising the step of producing a unique current signature that uniquely identifies the identifier.

18. The method of claim 15 wherein the conducting fluid is physiological fluid.

19. The method of claim 15 further comprising the step of securing the identifier to a pharmaceutical product to produce a tagged product such that activation of the circuit is an indication that the pharmaceutical product of the tagged product is in contact with physiological fluid.

20. The method of claim 19 further comprising the step of sealing the tagged product with a coating such that the tagged product is sealed from the physiological fluid for a predefined period of time until the coating is dissolved by the physiological fluid thereby allowing the tagged product to reach a target site at which time the tagged product is exposed to the physiological fluid.