Integrated ingestible event marker system with pharmaceutical product

• US 8,784,308 B2
• Filed: 12/02/2010
• Issued: 07/22/2014
• Est. Priority Date: 12/02/2009
• 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, Duck, Robert, Robertson, Timothy, Costello, Benedict
• Primary Examiner(s): Thomson, Bill
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US13/319,309
• Publication Number:
  US 20120116359A1
• Time in Patent Office: 1,328 Days
• Field of Search: 424/9.1, 424/400, 424/408, 424/438, 424439-441, 424/464, 424/474, 424489-490, 424/43, 600300-301, 600/372, 600/373, 604/890.1, 604/891.1, 604/891.2, 340/540, 340/573.1, 340/870.01, 205 57- 66, 156/60, 156/349
• US Class Current: 600/300
• 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 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/2886 having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209
• 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: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: B30B 11/34 for coating articles, e.g. tablets
• CPC Class Codes: B32B 2250/02 : 2 layers
• CPC Class Codes: B32B 38/0004 : Cutting, tearing or severing, e.g. bursting; Cutter details cutting in general B26D; laminating combined with punching or perforating B32B38/04; removing all or part of the layers B32B38/10; cutting in combination with laying up and registration B32B38/185 takes precedence
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 156/1066 : Cutting to shape joining edge surfaces only

Abstract

A system and method are provided for securing an ingestible electronic device to a pharmaceutical product without damaging the ingestible electronic device. The product includes the ingestible electronic device being placed on the product in accordance with one aspect of the present invention. In accordance with another aspect of the present invention, the ingestible electronic device is placed inside the product. Various embodiments are disclosed in accordance with the present invention for protecting and/or coating of the electronic marker as well as securing the ingestible electronic device onto the product.

Claims

1. A pharmaceutical product comprising:

a pill; and

a device including a top and a bottom, and secured to the pill, wherein the device comprises;

a non-conductive skirt that defines a central cavity;

a control unit positioned in the central cavity defined by the skirt, wherein the control unit includes at least a first material and a second material, wherein the first material is dissimilar from the second material, and wherein the first and second materials are positioned on opposite sides of the control unit and electrically connected thereto, wherein the first material is exposable at a first side of the skirt and the second material is exposable at a second side of the skirt such that the skirt separates the two dissimilar materials when exposed, wherein, when the first and second materials are exposed and in contact with a conductive fluid a voltage potential for powering the control unit is generated and a current flow is produced through the conductive fluid between the first and second materials that extends around the non-conductive skirt, and wherein the control unit, when powered, modulates the current flow to generate a current signature with information encoded in the current signature; and

a securing portion on the bottom of the device for securing the device to the pill.

2. The product of claim 1, further comprising a protective layer positioned on top of the device.

3. The product of claim 2, wherein the protective layer is the same size as the skirt and covers the top of the control unit.

4. The product of claim 2, wherein the securing portion is a plurality of adhesive dots positioned on the bottom of the device on the skirt.

5. The product of claim 4, wherein the securing portion is the same size as the device and covers the bottom of the device.

6. The product of claim 2, further comprising a second protective layer positioned on the bottom of the device and between the device and the securing portion.

7. The product of claim 6, wherein the second protective layer is the same size as the skirt and covers the bottom of control unit.

8. The product of claim 6, wherein the securing portion is a plurality of adhesive dots positioned on the second protective layer and about the device.

9. The product of claim 6, wherein the securing portion is the same size as the device and positioned onto the second protective layer.

10. A pharmaceutical product with an ingestible electronic marker, the product comprising:

a first tablet portion containing a drug; and

a second tablet portion containing a fast dissolving agent,

wherein the agent and drug are chemically compatible,

wherein the first tablet portion and second tablet portion define a cavity for holding the ingestible electronic marker, and

wherein the ingestible electronic marker includes;

a non-conductive skirt that defines a central cavity;

a control unit positioned in the central cavity defined by the skirt,

wherein the control unit includes at least two dissimilar materials separated by the skirt,

wherein the two dissimilar materials form a partial power source completable upon contact with a conductive fluid to provide a voltage potential to power the control unit, and wherein, when powered, the control unit generates a current signature with information encoded in the current signature; and

a coating to define a pocket that surrounds the skirt and control unit, wherein the coating dissolves away to expose the control unit to the surrounding environment.

11. The product of claim 10, wherein the tablet is placed inside of a capsule.

12. The product of claim 10, wherein the capsule is filled with a second drug.