# US 10,765,360 B2 · Electronic medication compliance monitoring system and associated methods

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- Number: US 10,765,360 B2
- Document ID: US10765360B2
- Status: Granted
- Kind: B2
- Application number: 16/408,642
- Filed: 2019-05-10
- Published: 2019-08-29
- Granted: 2020-09-08
- Earliest claimed: 2005-07-20
- Assignees: etectRx, Inc.
- Applicants: etectRx, Inc.
- Inventors: Neil R. Euliano; Brent A. Myers; Jose C. Principe; Venkata V. Meka; Glen Flores
- Web page: https://patentgrep.com/patent/US10765360B2

## CPC

- A61B 5/073: {Intestinal transmitters}
- A61B 5/06: Devices, other than using radiation, for detecting or locating foreign bodies {; Determining position of diagnostic devices within or on the body of the patient}
- 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}
- A61B 5/07: Endoradiosondes
- 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)}
- A61B 5/4205: {Evaluating swallowing}
- A61B 5/4833: {Assessment of subject's compliance to treatment}
- G08B 21/04: responsive to non-activity, e.g. of elderly persons (G08B21/06 takes precedence)
- G08B 21/0407: {based on behaviour analysis}
- G08B 23/00: Alarms responsive to unspecified undesired or abnormal conditions
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 40/63: for local operation
- A61B 5/14539: {for measuring pH}
- A61B 5/285: Endotracheal, oesophageal or gastric probes
- A61B 2560/0209: adapted for power saving
- A61B 2560/0214: of power generation or supply
- A61B 2562/12: Manufacturing methods specially adapted for producing sensors for in-vivo measurements
- A61B 2562/162: Capsule shaped sensor housings, e.g. for swallowing or implantation
- A61J 3/007: {Marking tablets or the like (apparatus for printing on tablets or the like B41F17/36)}
- A61J 2200/30: Compliance analysis for taking medication
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- G16H 20/13: delivered from dispensers
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G08B: SIGNALLING SYSTEMS, e.g. PERSONAL CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A system and method for monitoring a patient's compliance with a medication regimen includes an electronic tag integral with or attached to a medicine delivery device such as a capsule, the tag having an antenna and a receiver/transmitter, the system also including a reader positioned externally for detecting the presence and location of the delivery device in the patient.

## Claims

### Claim 1

An electronic system for monitoring a patient's compliance with a medication program, the electronic system comprising:
an ingestible medicine delivery device;
a tag fitted with the delivery device;
a tag electronic circuit carried by the tag, wherein the electronic circuit is capable of processing and transmitting one or more out-link radio frequency signals to indicate the delivery device is present within the patient's body;
an electronic reader adapted to be positioned externally adjacent the patient, wherein the reader is capable of processing the one or more out-link radio frequency signals received from the tag; and
a remote device configured to receive information from the electronic reader and generate data indicative of the patient's mediation compliance with the medication program based on the information received from the electronic reader.

### Claim 2 (depends on 1)

The electronic medication monitoring system recited in claim 1 wherein the remote device is further configured to transmit the generated data to a health provider of the patient.

### Claim 3 (depends on 1)

The electronic medication monitoring system recited in claim 1, wherein the generated data comprises a real-time estimation of blood levels associated with a specific medication based on one or more pharmacodynamics models and pharmacokinetics models.

### Claim 4 (depends on 1)

The electronic medication monitoring system recited in claim 1, wherein the generated data comprises a medication refill request.

### Claim 5 (depends on 1)

The electronic medication monitoring system recited in claim 1, wherein the generated data comprises an instruction on adverse drug reaction.

### Claim 6 (depends on 1)

The electronic medication monitoring system recited in claim 1, the generated data comprises a notification for the patient based on medication compliance status of the patient.

### Claim 7 (depends on 1)

The electronic medication monitoring system recited in claim 1, wherein the circuit is further capable of receiving one or more in-link radio frequency signals.

### Claim 8 (depends on 1)

The electronic medication monitoring system recited in claim 1, wherein the delivery device comprises a capsule having an outer surface and an inner surface with the tag fitted to one of the inner and outer surfaces.

### Claim 9 (depends on 1)

The electronic medication monitoring system recited in claim 1, wherein the one or more out-link radio frequency signals are coded with data representing at least one of the patient's identification, an identification for a medication trial, a medication type, and elapsed time of the tag in the patient's gastrointestinal tract.

### Claim 10 (depends on 1)

The electronic medication monitoring system recited in claim 1, wherein the electronic reader is further capable of receiving and processing out-link radio frequency signals from multiple tags simultaneously within the patient's body.

### Claim 11

An ingestible electronic tag system for use in tracking ingested medication in a patient's body, the ingestible electronic tag system comprising:
an electrically insulated substrate having an upper surface and an opposing lower surface;
a tag electronic circuit fitted to one of the surfaces of the substrate, wherein the tag electronic circuit is capable of transmitting one or more out-link signals containing data representative of a status of the tag and its location; and
an antenna disposed across one of the substrate surfaces and electrically coupled to the tag electronic circuit for transmitting the one or more out-link signals.

### Claim 12 (depends on 11)

The ingestible electronic tag system recited in claim 11, wherein the substrate comprises an ingestible coated paper, and wherein the coating and the paper dissolve in a presence of predetermined gastric fluids.

### Claim 13 (depends on 11)

The ingestible electronic tag system recited in claim 11, further comprising a galvanic gastric sensor fitted with the tag and coupled with the tag electronic circuit, the sensor providing varying inputs to the tag electronic circuit dependent upon location of the sensor in the patient's body.

### Claim 14 (depends on 11)

The ingestible electronic tag system recited in claim 11, further comprising an electronic reader adapted to be positioned adjacent the patient's body, wherein the electronic reader is capable of receiving and processing the one or more out-link signals from the tag electronic circuit.

### Claim 15 (depends on 14)

The ingestible electronic tag system recited in claim 14, further comprising a remote device configured to receive information from the electronic reader and generate data indicative of medication compliance status of the patient based on the information received from the electronic reader.

### Claim 16 (depends on 15)

The ingestible electronic tag system recited in claim 15, wherein remote device is further configured to transmit the generated data to a health provider of the patient.

### Claim 17 (depends on 15)

The ingestible electronic tag system recited in claim 15, wherein the generated data comprises a real-time estimation of blood levels associated with a specific medication based on one or more pharmacodynamics models and pharmacokinetics models.

### Claim 18 (depends on 15)

The ingestible electronic tag system recited in claim 15, wherein the generated data comprises a medication refill request.

### Claim 19 (depends on 15)

The ingestible electronic tag system recited in claim 15, wherein the generated data comprises an instruction on adverse drug reaction.

### Claim 20 (depends on 15)

The ingestible electronic tag system recited in claim 15, wherein the generated data comprises a notification for the patient based on medication compliance status of the patient.