Medication compliance system and associated methods

• US 7,796,043 B2
• Filed: 07/20/2006
• Issued: 09/14/2010
• Est. Priority Date: 07/20/2005
• Status: Active Grant

• Current Assignee: Etectrx Incorporated
• Original Assignee: Neil R. Euliano
• Inventors: Stahl, Michael W. Jr., Principe, Jose C., Euliano, Neil R., Meka, Vikas V.
• Primary Examiner(s): Lee; Benjamin C
• Assistant Examiner(s): TANG, SIGMUND N
• Application Number:
  US11/458,815
• Publication Number:
  US 20070123772A1
• Time in Patent Office: 1,517 Days
• Field of Search: 3405721-5729, 340/10.1, 340/573.1, 600/300, 600/407, 600/411
• US Class Current: 340/573.1
• 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 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/06 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 5/065 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 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/285 Endotracheal, oesophageal or gastric probes
• 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 5/4205 Evaluating swallowing
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 3/007 Marking tablets or the like apparatus for printing on tablets or the like B41F17/36
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: G08B 21/04 responsive to non-activity, e.g. of elderly persons G08B21/06 takes precedence
• CPC Class Codes: G08B 21/0407 based on behaviour analysis
• CPC Class Codes: G08B 23/00 Alarms responsive to unspecified undesired or abnormal conditions
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

A system for monitoring medication compliance in a patient includes an electronic pill that includes a drug-transporting device and an antenna positioned on a surface of the drug-transporting device. A detector is positionable external a gastrointestinal tract of a patient for detecting a presence of the antenna in the patient gastrointestinal tract.

Claims

1. A method for making an electronic pill adapted for monitoring for medication compliance in a patient, the method comprising the steps of:

mounting a receive/transmit antenna and electronic circuit onto a flexible substrate;

fitting the substrate to the exterior surface of an ingestible medication delivery device by wrapping the substrate and the receive/transmit antenna continuously around a curved portion of the exterior surface of the ingestible medication delivery device;

said receive/transmit antenna is formed of one of carbon black, silver ink, iron, a conducting polymer and an edible ink;

the antenna detectable from a gastrointestinal tract of the patient by a detecting device positionable external the patient gastrointestinal tract;

filling the delivery device with a medication;

temporarily storing within the medication delivery device power received from the detecting device; and

then

after a time delay following the storing step, transmitting from the medication delivery device to the detecting device a signal using the temporarily stored power, the signal indicating the presence of the medication delivery device within the patient.

2. The method recited in claim 1, further comprising the step of forwarding a result of the transmitting step to a monitoring agency.

3. The method recited in claim 1, further comprising the step of placing a the detecting device adjacent one of a torso and a neck of the patient for detecting a position of the electronic pill in a stomach and an esophagus of the patient, respectively.

4. The method recited in claim 1, wherein the transmitting step further comprises storing a time of the transmission.

5. The method recited in claim 1, further comprising the steps of sending a first signal to the antenna from the detecting device and receiving a second signal in response thereto from the antenna, the second signal different from the first signal.

6. The method recited in claim 1, wherein the electronic pill further comprises an integrated circuit in signal communication with the antenna, the integrated circuit communicating via the antenna to the detecting device.

7. The method recited in claim 6, wherein the integrated circuit and the antenna are adapted to emit a signal in the radio frequency (RF) range.

8. The method recited in claim 1, wherein the electronic pill further comprises a pH sensor in communication with the antenna for monitoring a presence of stomach acid.

9. The method recited in claim 1, further comprising the step of applying a material having a characteristic alterable in a presence of a component of the gastrointestinal tract to at least a portion of the delivery device surface in physical communication with the antenna, the antenna adapted to emit a first signal when the material is not in contact with the gastrointestinal tract component and a second signal different from the first signal when in contact with the gastrointestinal tract component.

10. The method recited in claim 1, further comprising the step of applying a biocompatible shielding material atop the antenna for shielding the antenna from contents of the gastrointestinal tract.

11. The method recited in claim 1, wherein the substrate comprises a flexible substantially planar element, and wherein the fitting step comprises affixing the planar element to the delivery device surface.

12. The method recited in claim 1, further comprising the step of coating a conductive sensor with a substance adapted to act as a bio-switch in a presence of a bodily fluid, and wherein the electronic pill further comprises a transmitter in signal communication with the sensor and the antenna, and wherein the detecting step comprises detecting a predetermined signal from the antenna, the antenna signal having been elicited by a transmitter signal that in turn has been caused by an actuation of the sensor.

13. The method recited in claim 1, further comprising the step of encasing the delivery device with an overlayer following the antenna fitting step.

14. The method recited in claim 1, wherein the fitting step comprises one of printing and depositing the antenna on the substrate.

15. The method recited in claim 1, further comprising the step of providing means with the delivery device for converting gastrointestinal fluid into electrical power.

16. The method recited in claim 15, wherein the converting means comprises an oxidizable zinc electrode which creates electrical current in the presence of stomach acid.

17. The method recited in claim 16, further comprising a conductive electrode on the delivery device and coupled to the zinc electrode for forming a return transmitting path.

18. A system for electronically monitoring an ingestible capsule, the system comprising:

an ingestible capsule having an exterior surface;

a flexible substrate fitted to the exterior surface of the ingestible capsule;

a receive/transmit antenna and an electronic circuit, both the receive/transmit antenna and the electronic circuit mounted in electrically conductive contact with each other on the substrate, wherein the substrate and the receive/transmit antenna are wrapped continuously around a curved portion of the exterior surface of the ingestible capsule, wherein said receive/transmit antenna is formed of one of carbon black, silver ink, iron, a conducting polymer and an edible ink; and

detector means for transmitting wireless signals to the electronic circuit through the receive/transmit antenna and for receiving wireless signals from the electronic circuit through the receive/transmit antenna.

19. The system recited in claim 18, wherein the circuit and the antenna are adapted to emit a signal in the radio frequency (RF) range.

20. The system recited in claim 18, further comprising a pH sensor in communication with the antenna for monitoring a presence of stomach acid.

21. The system recited in claim 18, further comprising a material having a characteristic that is alterable in a presence of a component of the gastrointestinal tract, the characteristic interactive with the antenna so that the antenna transmits a first signal to the detecting device when the characteristic is in a first state in an absence of the gastrointestinal tract component and transmits a second signal to the detecting device different from the first signal when the characteristic is in a second state in the presence of the gastrointestinal tract component.

22. The system recited in claim 18, further comprising a biocompatible shielding material positioned atop the antenna for shielding the antenna from contents of the gastrointestinal tract.

23. The system recited in claim 18, wherein the antenna comprises a conductive, biocompatible material.

24. The system recited in claim 18, wherein the flexible substrate comprises a substantially planar element encircling a substantial portion of the capsule surface.

25. The system recited in claim 18, further comprising a conductive sensor coated with a substance that acts as a bio-switch in a presence of a bodily fluid, the transmitter in signal communication with the sensor and the antenna, a predetermined signal from the sensor causing the transmitter to signal the antenna to emit a signal to the detector means.

26. The system recited in claim 18, further comprising a power source with the capsule.

27. The system recited in claim 18, wherein the circuit and the antenna are adapted to transmit signals in the radio frequency (RF) range, and the detector means is adapted to receive transmissions from the antenna of the capsule in the RF range.

28. The system recited in claim 18, further comprising a conductive sensor coated with a substance adapted to act as a bio-switch in a presence of a bodily fluid, the circuit in signal communication with the bio-switch and the antenna, whereby a predetermined signal from the bio-switch causes the circuit to signal the antenna to transmit a signal to the detector means.

29. The medication compliance system recited in claim 18, wherein the wireless reader is positionable adjacent a neck of the patient for detecting a passage of the capsule through the esophagus.

30. The system recited in claim 18 wherein the system further comprises:

means with the electronic circuit for storing data identifying the ingestible capsule; and

means for transmitting the identification data to the detector means through the receive/transmit antenna.

31. The system recited in claim 18 wherein the ingestible capsule contains a medication.

32. A method for electronically monitoring an ingestible capsule, the method comprising the steps of:

providing an ingestible capsule having an exterior surface;

mounting a receive/transmit antenna and an electronic circuit onto a flexible substrate with the receive/transmit antenna and the electronic circuit in electronic contact with each other;

fitting the substrate to the exterior surface of the ingestible capsule;

by wrapping the substrate and the receive/transmit antenna continuously around a curved portion of the exterior surface of the ingestible medication delivery device;

said receive/transmit antenna is formed of one of carbon black, silver ink, iron, a conducting polymer and an edible ink;

transmitting wireless signals to the electronic circuit through the receive/transmit antenna; and

receiving wireless signals from the electronic circuit through the receive/transmit antenna for purposes of detecting the presence of the ingestible capsule;

wherein said ingestible capsule is filled with a medication.