# US 2019/0244510 A1 · Apparatus and Method for Improved Drug Dosing-Regimen Compliance

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2019/0244510 A1
- Document ID: US20190244510A1
- Status: Published application
- Kind: A1
- Application number: 16/385,176
- Filed: 2019-04-16
- Published: 2019-08-08
- Earliest claimed: 2016-04-08
- Assignees: QuantaEd, LLC
- Applicants: QuantaEd, LLC
- Inventors: Mehran Mehregany
- Web page: https://patentgrep.com/patent/US20190244510A1

## CPC

- G08B 21/24: Reminder alarms, e.g. anti-loss alarms
- A61J 1/035: {Blister-type containers (blisters in general B65D75/36)}
- A61J 7/0418: {with electronic history memory}
- A61J 7/0436: {resulting from removing a drug from, or opening, a container}
- A61J 7/049: {automatically changing in response to a schedule deviation by the patient}
- A61J 7/0481: {working on a schedule basis}
- A61J 2200/30: Compliance analysis for taking medication
- A61J 2200/70: Device provided with specific sensor or indicating means
- A61J 2205/70: Audible labels, e.g. for pre-recorded info or messages
- G08B: SIGNALLING SYSTEMS, e.g. PERSONAL CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
- 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

## Abstract

A method and apparatus for monitoring adherence to a dosing-regimen for a medication is presented. Systems in accordance with the present invention automatically monitor the medicine content of a blister card based on the state of its lidding film and compare it to the prescribed dosing regimen for the medicine. In some embodiments, the lidding film is imaged using a tomographic imaging technique, such as electrical resistance tomography or electrical impedance tomography. Alternative sensing approaches are based on optical, acoustic, and tactile sensors that interrogate either the dispensing region at each tablet location or the tablets themselves to determine whether tablets have been dispensed. Automatic monitoring of the blister card enables the user to be: (1) alerted to non-compliance, (2) alerted to a risk of future non-compliance, and/or (3) to be provided remediation instructions when non-compliance is determined.

## Claims

### Claim 1

A method for monitoring compliance of a user to a dosing regimen for a prescription that includes a plurality of tablets included in a blister card that includes a forming film and a lidding film that is unpatterned, the forming film and a monitoring region of the lidding film collectively defining a plurality of reservoirs for holding the plurality of tablets, wherein each tablet has a corresponding dosing window that starts at a dosing-window start time and ends at a dosing-window end time, the method comprising:
providing a package that includes a detection module and a receiver for locating the blister card such that it is operatively coupled with the detection module;
operatively coupling the detection module and the blister card, the detection module being configured to monitor the state of the monitoring region;
monitoring the state of the monitoring region;
performing a first comparison of a first state of the monitoring region at a first time and an expected state of the monitoring region at the first time, the expected state being based on the dosing regimen; and
generating a first output signal based on the first comparison, wherein the first output signal has a first characteristic when the first comparison indicates compliance with the dosing regimen and a second characteristic when the first comparison indicates non-compliance with the dosing regimen.

### Claim 2 (depends on 1)

The method of claim 1 further comprising:
determining a first geolocation of the user at a second time;
determining a second geolocation of the detection module at the second time;
determining a risk for future non-noncompliance based on at least the first geolocation, the second geolocation, the second time, and the next dosing window of the sequence thereof; and
generating an alert if the risk exceeds a threshold.

### Claim 3 (depends on 2)

The method of claim 2 further comprising:
comparing the sequence of dosing windows and an event on a calendar, the event having an event-duration that extends from an event-start time to an event-end time; and
generating the alert if at least one dosing window overlaps at least a portion of the event-duration.

### Claim 4 (depends on 3)

The method of claim 3 further comprising generating the alert based on a distance between the second geolocation and a third geolocation that corresponds to the event.

### Claim 5 (depends on 2)

The method of claim 2 wherein the first geolocation is based on a third geolocation of a device that is electronically paired with the package.

### Claim 6 (depends on 1)

The method of claim 1 wherein the detection module monitors the monitoring region via a tomographic technique.

### Claim 7 (depends on 6)

The method of claim 6 wherein the tomographic technique is selected from the group consisting of electrical resistance tomography and electrical impedance tomography.

### Claim 8 (depends on 1)

The method of claim 1 further comprising providing remediation guidance to the user when the first comparison indicates non-compliance with the dosing regimen.

### Claim 9 (depends on 1)

The method of claim 1 further comprising:
performing a second comparison of the first state to a second state of the blister card at a second time that precedes the first time;
identifying the location of a perturbation in the monitoring region based on the second comparison;
identifying a first tablet of the plurality thereof that corresponds to the perturbation; and
recording the first time and identity of the first tablet in a data-storage device.

### Claim 10 (depends on 1)

The method of claim 1 wherein the first time is a dosing-window end time of a dosing window of the plurality thereof, and wherein the method further comprises:
at each of a plurality of second times, each second time being the dosing-window end time of a different dosing window of the plurality thereof, performing a second comparison of a second state of the monitoring region at the second time with the expected state of the monitoring region at the second time, wherein the plurality of second comparisons includes the first comparison and the plurality of dosing-window end times includes the first time; and
for each second time of the plurality thereof, storing the second time and the second state of the monitoring region.

### Claim 11 (depends on 1)

The method of claim 1 further comprising generating an exhaustion warning based on the first comparison.

### Claim 12 (depends on 1)

The method of claim 1 providing prescription information to the user via at least one of (1) a display located on the package and (2) a device that is electronically paired with the package, wherein the display includes at least one of a visual indicator, an audible indicator, and an alphanumeric display.

### Claim 13

A method for monitoring compliance of a user to a dosing regimen for a prescription that includes a plurality of tablets included in a blister card that includes a forming film and a lidding film that is unpatterned, the forming film and a monitoring region of the lidding film collectively defining a plurality of reservoirs for holding the plurality of tablets, wherein each tablet has a corresponding dosing window that starts at a dosing-window start time and ends at a dosing-window end time, the method comprising:
for each of a plurality of first times, t(i), where i is equal to 1 through N and N is the number of tablets in the blister card:
(i) determining a first state of the monitoring region by forming image(i) of the lidding film via a tomographic technique selected from the group consisting of electrical resistance tomography and electrical impedance tomography;
(ii) performing a first comparison of the first state at t(i) and an expected state of the monitoring region at t(i), wherein the expected state is based on the dosing regimen; and
(iii) generating a first output signal based on the first comparison, wherein the first output signal has a first characteristic when the first comparison indicates compliance with the dosing regimen and a second characteristic when the first comparison indicates non-compliance with the dosing regimen.

### Claim 14 (depends on 13)

The method of claim 13 further comprising:
(iv) comparing image(i) and image (i−1), wherein image(0) is a model of the monitoring region when it is perturbation-free;
(v) determining a first location of a first difference between image(i) and image (i−1); and
(vi) identifying at least one tablet, tablet(i) of the plurality of tablets that was dispensed between times t(i) and t(i−1) based on the first location.

### Claim 15 (depends on 14)

The method of claim 14 further comprising storing each of t(1) through t(N) and tablets(1) through tablet(N) in a data-storage system.

### Claim 16 (depends on 13)

The method of claim 13 further comprising:
determining a first geolocation of the user at a second time;
determining a second geolocation of the detection module at the second time;
determining a risk for future non-noncompliance based on at least the first geolocation, the second geolocation, the second time, and the plurality of dosing windows; and
generating an alert if the risk exceeds a threshold.

### Claim 17 (depends on 16)

The method of claim 16 further comprising:
comparing the sequence of dosing windows and an event on a calendar, the event having an event-duration that extends from an event-start time to an event-end time; and
generating the alert if at least one dosing window overlaps at least a portion of the event-duration.

### Claim 18 (depends on 17)

The method of claim 17 further comprising generating the alert based on a distance between the second geolocation and a third geolocation that corresponds to the event.

### Claim 19 (depends on 16)

The method of claim 16 wherein the first geolocation is based on a third geolocation of a device that is electronically paired with the package.

### Claim 20 (depends on 13)

The method of claim 13 further comprising generating an exhaustion warning based on the first comparison.

### Claim 21 (depends on 13)

The method of claim 13 providing prescription information to the user via at least one of (1) a display located on the package and (2) a device that is electronically paired with the package, wherein the display includes at least one of a visual indicator, an audible indicator, and an alphanumeric display.

### Claim 22

A system for monitoring the compliance of a user to a dosing regimen for a prescription that includes a plurality of tablets included in a blister card that includes a forming film and a lidding film that is unpatterned, the forming film and a monitoring region of the lidding film collectively defining a plurality of reservoirs for holding the plurality of tablets, wherein each tablet has a corresponding dosing window that starts at a dosing-window start time and ends at a dosing-window end time, the system comprising:
a detection module that is configured to monitor the state of the monitoring region when the blister card is in a first position;
a receiver for securing the blister card in the first position; and
an electronics module that is configured to:
(1) perform a first comparison between a first state of the monitoring region at a first time and an expected state of the monitoring region at the first time, the expected state being based on the dosing regimen; and
(2) generate a first output signal based on the first comparison, wherein the first output signal has a first characteristic when the first comparison indicates compliance with the dosing regimen and a second characteristic when the first comparison indicates non-compliance with the dosing regimen.

### Claim 23 (depends on 22)

The system of claim 22 wherein the detection module is configured to monitor the state of the monitoring region by a tomographic technique that is selected from the group consisting of electrical resistance tomography and electrical impedance tomography.

### Claim 24 (depends on 22)

The system of claim 22 wherein the detection module is configured to monitor the state of the monitoring region by a sensing technique selected from the group consisting of capacitive, optical, acoustic, and tactile sensing

### Claim 25 (depends on 22)

The system of claim 22 wherein the electronics module is operative for:
determining a first geolocation of the user at a second time;
determining a second geolocation of the detection module at the second time;
determining a risk for future non-compliance based on at least the first geolocation, the second geolocation, the second time, and the next dosing window of the sequence thereof; and
generating an alert if the risk exceeds a threshold.

### Claim 26 (depends on 25)

The system of claim 25 wherein the electronics module is further operative for:
comparing the sequence of dosing windows and an event on a calendar, the event having an event-duration that extends from an event-start time to an event-end time; and
generating the alert if at least one dosing window overlaps at least a portion of the event-duration.

### Claim 27 (depends on 26)

The system of claim 26 wherein the electronics module is further operative for generating the alert based on a distance between the second geolocation and a third geolocation that corresponds to the event.

### Claim 28 (depends on 25)

The system of claim 25 wherein the first geolocation is based on a third geolocation of a device that is electronically paired with system.

### Claim 29 (depends on 22)

The system of claim 22 wherein the electronics module is operative for providing remediation guidance to the user when the first comparison indicates non-compliance with the dosing regimen.

### Claim 30 (depends on 22)

The system of claim 22 wherein the electronics module is operative for providing an exhaustion warning that is based on the first comparison.

### Claim 31 (depends on 22)

The system of claim 22 further comprising a display that includes at least one of a visual indicator, an audible indicator, and an alphanumeric display.

### Claim 32 (depends on 22)

The system of claim 22 wherein the receiver includes a frame that has (1) an unclamped orientation that enables motion of the blister card relative to the detection module and (2) a clamped orientation that enables the frame to secure the blister card in the first position.

### Claim 33 (depends on 32)

The system of claim 32 wherein the frame has a curvature in at least one dimension when the frame is in its unclamped orientation, and wherein, when the frame is in its clamped orientation and the blister card is in the first position, the curvature is reduced by a force that exists between the frame and the blister card.

### Claim 34 (depends on 33)

The system of claim 33 wherein the force is substantially evenly distributed over the area of the frame.

### Claim 35 (depends on 32)

The system of claim 32 wherein the receiver further includes a friction layer that is configured to inhibit a change in the positional relationship between the blister card and the detection module when the blister card is in the first position and the frame is in its clamped position.