Method and apparatus for monitoring ingestion of medications using an implantable medical device

• US 8,269,635 B2
• Filed: 02/12/2010
• Issued: 09/18/2012
• Est. Priority Date: 11/09/2004
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Kroll, Mark W., Vogel, Alan B.
• Primary Examiner(s): Tweel, Jr., John A
• Application Number:
  US12/705,435
• Publication Number:
  US 20100139672A1
• Time in Patent Office: 949 Days
• Field of Search: 340/573.1, 340/572.1, 340/573.3, 340/10.1, 340/10.3, 128/899, 128/903, 600/302, 607/60
• US Class Current: 340/573.1
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1123 Discriminating type of movement, e.g. walking or running A61B5/1116, A61B5/112 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: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 7/008 Detecting noise of gastric tract, e.g. caused by voiding
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

An implantable medical device, such as a pacemaker or implantable cardioverter defibrillator (ICD), is configured to automatically detect ingestion of medications to verify that prescribed medications are taken in a timely manner and at the correct dosage. Briefly, individual pills are provided with miniature radio frequency identification (RFID) devices capable of transmitting RFID tag signals, which identify the medication contained within the pill and its dosage. The implanted device is equipped with an RFID transceiver for receiving tag signals from a pill as it is being ingested. The implanted system decodes the tag to identify the medication and its dosage, then accesses an onboard database to verify that the medication being ingested was in fact prescribed to the patient and to verify that the correct dosage was taken. Warning signals are generated if the wrong medication or the wrong dosage was taken. Therapy may also be automatically adjusted. Non-RF-based ID devices are also described, which instead transmit ID data via biphasic current pulses.

Claims

1. In an implantable medical device, a method for monitoring the ingestion of a pill by a patient, the method comprising:

sensing a signal transmitted by a pill being ingested wherein the signal transmitted by the pill comprises biphasic current pulses;

detecting ingestion of the pill based on the sensed signal; and

automatically recording, within the implantable medical device, data indicative of the time the pill was ingested.

2. The method of claim 1 wherein the pill is equipped with radio frequency identification (RFID) device and wherein sensing the signal transmitted by the pill comprises sensing an RFID signal transmitted by the RFID device of the pill.

3. The method of claim 2 wherein the RFID device is an active ID device and wherein sensing the signal transmitted by the pill comprises sensing active ID signals transmitted by the ID device.

4. The method of claim 2 wherein the pill is equipped with a passive RFID device and wherein sensing signals comprises:

transmitting a power signal to the passive RFID device of the pill; and

receiving a responsive signal returned by the passive RFID device of the pill.

5. The method of claim 1 and further comprising comparing the pill against a database listing medications prescribed to the patient.

6. The method of claim 5 and further comprising generating a warning signal if the pill is not listed in the database.

7. The method of claim 6 wherein generating a warning signal is performed by transmitting a warning signal to an external warning device.

8. The method of claim 1 further comprising determining a dosage of the pill being ingested.

9. The method of claim 8 further comprising:

determining whether the dosage being ingested is a dosage prescribed to the patient; and

generating a warning signal if the dosage being ingested is not the dosage prescribed to the patient.

10. The method of claim 8 further comprising determining the dosage taken by the patient over a period of time, comparing the dosage over the period of time to a schedule, and determining whether the patient has taken a correct dosage over the period of time.

11. In an implantable medical system comprising a housing containing circuitry and one or more leads connected to the housing, a method for monitoring the ingestion of pills by a patient, the method comprising:

sensing, by the one or more leads, a signal transmitted by a pill being ingested by the patient wherein the signal transmitted by the pill comprises biphasic current pulses;

transmitting the signals from the one or more leads to the circuitry within the housing; and

processing the signals by the circuitry to detect ingestion of the pill by the patient.

12. The method of claim 11 wherein sensing by the one or more leads comprises using two electrodes on the one or more leads to serve as an antenna.

13. The method of claim 11 and further comprising verifying that the pill is prescribed to the patient.

14. The method of claim 13 and further comprising adjusting therapy by the circuitry if the pill is not prescribed to the patient.

15. The method of claim 13 and further comprising generating a warning signal in response to the patient failing to take any prescribed medications.

16. An implantable system for use in monitoring the ingestion of pills by a patient, the system comprising:

one or more leads adapted to sense signals transmitted by signal-transmitting pills being ingested by the patient wherein the signals transmitted by the pill comprise biphasic current pulses; and

a medication monitoring controller adapted to be connected to the one or more leads to receive the signals from the one or more leads and to process the signals to detect ingestion of a pill by the patient.

17. The system of claim 16 wherein the medication monitoring controller is programmed to verify that the pill is prescribed to the patient.

18. The system of claim 17 wherein the medication monitoring controller is programmed to adjust therapy if the pill is not prescribed to the patient.

19. The system of claim 17 wherein the medication monitoring controller is programmed to generate a warning signal if the pill is not prescribed to the patient.