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

• US 7,414,534 B1
• Filed: 11/09/2004
• Issued: 08/19/2008
• Est. Priority Date: 11/09/2004
• Status: Active Grant

• 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 ALEXANDER
• Application Number:
  US10/985,298
• Time in Patent Office: 1,379 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. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

wherein the individual 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;

wherein the individual 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;

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

wherein the implantable system is equipped to detect and classify patient movement and wherein transmitting a power signal to the passive RFID device is triggered by detection of patient motion that is consistent with the swallowing of a pill.

2. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

wherein the individual 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;

wherein the individual 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;

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

wherein the implantable system is equipped to detect internal patient sounds and wherein transmitting a power signal to the passive RFID device is triggered by detection of sounds consistent with swallowing a pill.

3. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

wherein the individual 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;

wherein the individual 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;

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

wherein the implantable system is equipped to detect and classify patient posture and wherein transmitting a power signal to the passive RFID device is not performed unless patient posture is consistent with the swallowing of a pill.

4. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

wherein the individual 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;

wherein the individual 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;

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

wherein the implantable system is equipped to detect patient sleep and wherein transmitting a power signal to the passive RFID device is not performed if the patient is asleep.

5. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

wherein the individual 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;

wherein the RFID signal includes an RFID tag sufficient to identify the medication being ingested and wherein detecting ingestion of a pill comprises;

decoding the RFID tag of the RFID signal;

comparing the decoded RFID tag against a database listing individual RFID tags and the particular medications associated therewith; and

generating a signal indicative of the particular medication being ingested if the decoded RFID tag matches an RFID tag stored in the database; and

further comprising;

determining whether the medication being ingested is among medications prescribed to the patient; and

generating a warning signal if the medication being ingested is not among medications prescribed to the patient.

6. The method of claim 5 wherein whether the medication being ingested is among medications prescribed to the patient comprises comparing the medication being ingested against a database listing medications prescribed to the patient.

7. The method of claim 5 wherein the implanted system includes an implanted warning device for generating a perceptible signal and wherein generating a warning signal is performed by activating the implanted warning device.

8. The method of claim 5 wherein the implanted system is used in conjunction with an external warning device and wherein generating a warning signal is performed by transmitting a warning signal to the external warning device.

9. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

wherein the individual 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;

wherein the RFID signal includes an RFID tag sufficient to identify the medication being ingested and wherein detecting ingestion of a pill comprises;

decoding the RFID tag of the RFID signal;

comparing the decoded RFID tag against a database listing individual RFID tags and the particular medications associated therewith;

generating a signal indicative of the particular medication being ingested if the decoded RFID tag matches an RFID tag stored in the database;

wherein the RFID tag is also sufficient to identify the dosage of the medication being ingested and wherein detecting ingestion of a pill also comprises generating a signal indicative of the dosage being ingested; and

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 9 wherein determining whether the dosage being ingested is the dosage prescribed to the patient comprises comparing the dosage being ingested against a database listing the dosage prescribed to the patient for the particular medication being ingested.

11. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

wherein the individual 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;

wherein the RFID signal includes an RFID tag sufficient to identify the medication being ingested and wherein detecting ingestion of a pill comprises;

decoding the RFID tag of the RFID signal;

comparing the decoded RFID tag against a database listing individual RFID tags and the particular medications associated therewith;

generating a signal indicative of the particular medication being ingested if the decoded RFID tag matches an RFID tag stored in the database;

wherein the RFID tag is also sufficient to identify the dosage of the medication being ingested and wherein detecting ingestion of a pill also comprises generating a signal indicative of the dosage being ingested; and

further comprising recording information identifying the dosage of the medication being ingested.

12. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

determining whether the patient has failed to take prescribed medications;

wherein determining whether the patient has failed to take prescribed medications comprises;

accessing a database listing medications prescribed to the patient and a time frame in which the medication is expected to be taken; and

generating a warning signal if there is no detection of ingestion of the prescribed medication within the expected time frame.

13. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

determining whether the patient has failed to take prescribed medications;

controlling therapy in response to failure to take a prescribed medication;

wherein the prescribed medication includes heart medication, wherein the implantable system is equipped to perform pacing therapy and wherein controlling therapy in response to failure to take the prescribed medication comprises controlling pacing therapy in an attempt to compensate for failure to take the prescribed medication.

14. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

determining whether the patient has failed to take prescribed medications;

controlling therapy in response to failure to take a prescribed medication;

wherein the prescribed medication includes medication provided to prevent atrial fibrillation (AF), wherein the implantable system is equipped to deliver atrial overdrive pacing to prevent AF and wherein controlling therapy in response to failure to take the prescribed medication comprises activating overdrive pacing.

15. A method for use in monitoring the ingestion of pills by a patient in which an implantable medical system is implanted, the method comprising:

sensing a signal transmitted by an individual pill being ingested;

detecting ingestion of the pill based on the sensed signal;

determining whether the patient has failed to take prescribed medications;

controlling therapy in response to failure to take a prescribed medication;

wherein the implantable system is equipped with a drug pump provided with a quantity of medication and wherein controlling therapy in response to failure to take prescribed medication comprises controlling the drug pump to deliver a quantity of medication stored therein.