Pharma-informatics system

• US 10,610,128 B2
• Filed: 10/20/2017
• Issued: 04/07/2020
• 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, Thompson, Andrew, Pikelny, Aleksandr, Robertson, Timothy L., Hafezi, Hooman
• Primary Examiner(s): Holloway, III, Edwin C
• Application Number:
  US15/788,968
• Publication Number:
  US 20180214048A1
• Time in Patent Office: 900 Days
• Field of Search: 340 101
• 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

A system for administering prescription medications including a composition and a receiver. The composition may include an active agent, an identifier, and a pharmaceutically acceptable carrier. The active agent may include a controlled pharmaceutical. The identifier may include: a partial power source having a first material and a second material configured to generate a voltage in contact with a conductive fluid within a body of a patient, and a signal generation component configured to use at least a portion of the generated voltage to transmit a signal through the body of the patient. The receiver may be positioned near the body of the patient, wherein the receiver is configured to: receive the signal transmitted through the body of the patient, and automatically report the signal for at least one of identification of the controlled pharmaceutical or tracking physical administration of the controlled pharmaceutical to the body of the patient.

Claims

1. A system for administering prescription medications, the system comprising:

a composition among a plurality of compositions, each composition comprising;

an active agent, wherein the active agent comprises a controlled pharmaceutical;

an identifier, wherein the identifier comprises;

a partial power source comprising a first material and a second material, wherein the first material and the second material are configured to generate a voltage in contact with a conductive fluid within a body of a patient;

a signal generation component, wherein the signal generation component is configured to use at least a portion of the generated voltage to transmit a signal through the body of the patient; and

a pharmaceutically acceptable carrier; and

an external apparatus positioned near the body of the patient, wherein the external apparatus is configured to;

house and dispense the plurality of compositions;

receive an indication that the composition was ingested by the patient, based on the signal being transmitted through the body of the patient;

in response to receiving the indication, locking the external apparatus to prevent dispensing of another composition among the plurality of compositions; and

after a predetermined amount of time from locking the external apparatus, unlocking the external apparatus to dispense another composition among the plurality of compositions.

2. The system of claim 1, further comprising:

a sensor configured to detect a physiological response to the physical administration of the controlled pharmaceutical to the body of the patient;

a receiver configured to receive the signal transmitted through the body of the patient;

a remote system communicatively coupled to the receiver, wherein the remote system is configured to;

identify the controlled pharmaceutical based on the signal reported by the receiver;

correlate the physical administration of the controlled pharmaceutical to the detected physiological response to adjust at least one of a dosage and a timing of a future physical administration of the controlled pharmaceutical.

3. The system of claim 2, wherein the remote system is configured to correlate the physical administration of the controlled pharmaceutical to the detected physiological response to titrate the controlled pharmaceutical for the patient.

4. The system of claim 2, wherein the remote system is configured to correlate the physical administration of the controlled pharmaceutical to the detected physiological response to wean the patient off the controlled pharmaceutical.

5. The system of claim 2, wherein the detected physiological response comprises a negative physiological response, and wherein the remote system is configured to correlate the physical administration of the controlled pharmaceutical to the negative physiological response to titrate the controlled pharmaceutical for the patient.

6. The system of claim 1, further comprising:

a receiver configured to receive the signal transmitted through the body of the patient;

a remote system communicatively coupled to the receiver, wherein the remote system is configured to;

identify the controlled pharmaceutical based on the signal reported by the receiver; and

store a record to track the physical administration of the controlled pharmaceutical, wherein the record comprises an identifier of the controlled pharmaceutical, a time the controlled pharmaceutical was physically administered to the body of the patient, and an identifier of the patient.

7. The system of claim 6, wherein the composition further comprises a particular unit dosage of the controlled pharmaceutical from a defined batch of identical unit dosages of the controlled pharmaceutical, and wherein the remote system is further configured to verify, based on stored records, whether the defined batch of identical unit dosages has been physically administered to the body of the patient within a defined time period.

8. The system of claim 7, wherein the defined batch of identical unit dosages comprises a prescription for the controlled pharmaceutical, wherein the defined time period comprises a prescribed time to physically administer the defined batch of identical unit dosages, and wherein transmission of the prescription refill signal is contingent on a verification that the prescription has been physically administered to the body of the patient in accordance with the prescribed time.

9. The system of claim 1, wherein the identifier further comprises an energizable coil, wherein the energizable coil is configured to communicate an identification of the controlled pharmaceutical after the composition is interrogated by an interrogation device.

10. The system of claim 1, further comprising:

an interrogation device to identify one or more than one controlled pharmaceutical physically administered to the body of the patient in a defined time period, wherein the interrogation device is configured to;

interrogate the receiver for one or more than one signal transmitted through the body of the patient in the defined time period; and

identify one or more than one controlled pharmaceutical based on one or more than one signal reported by the receiver.

11. The system of claim 10, wherein the defined time period comprises a time period within the last day.

12. The system of claim 1, wherein the composition is in the form of a tablet or a capsule.

13. The system of claim 1, wherein the controlled pharmaceutical comprises a pain-relief agent.

14. The system of claim 1, wherein the controlled pharmaceutical comprises an opioid.

15. The system of claim 1, wherein the signal is a unique signal that identifies the controlled pharmaceutical.

16. The system of claim 15, wherein the unique signal identifies a particular unit dosage of the controlled pharmaceutical from a defined batch of identical unit dosages of the controlled pharmaceutical.

17. The system of claim 1, further comprising:

an external device communicatively coupled to the receiver, wherein the external device is configured to;

track each physical administration of the controlled pharmaceutical to the body of the patient based on each signal reported by the receiver;

determine that the patient is non-compliant with a prescribed regimen of the controlled pharmaceutical; and

automatically alert a caregiver to provide a remedial action.

18. The system of claim 17, wherein determining that the patient is non-compliant comprises determining that the patient has underdosed or overdosed based on a plurality of signals reported by the receiver.

19. The system of claim 1, wherein:

the signal is a monophasic electrically conductive signal associated with the composition;

the signal generation element is configured to generate the monophasic electrically conductive signal by modulating current flow through an electrically conductive medium of the body of the patient to transmit the monophasic electrically conductive signal through the electrically conductive medium; and

the receiver is configured to receive the monophasic electrically conductive signal through the electrically conductive medium.