# US 12,213,798 B2 · Adherence-tracking and monitoring device for metered-dose inhaler

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- Number: US 12,213,798 B2
- Document ID: US12213798B2
- Status: Granted
- Kind: B2
- Application number: 16/630,391
- Filed: 2018-07-11
- Published: 2021-03-04
- Granted: 2025-02-04
- Earliest claimed: 2017-07-11
- Assignees: Cipla Limited
- Applicants: Cipla Limited
- Inventors: Nandan Kulkarni; Geena Malhotra; Brinder Ahluwalia; Mohnish Jagdish Zaveri
- Web page: https://patentgrep.com/patent/US12213798B2

## CPC

- A61B 5/4833: {Assessment of subject's compliance to treatment}
- A61B 5/087: Measuring breath flow
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61M 15/0026: {Hinged caps}
- A61M 15/008: {Electronic counters}
- A61M 15/0083: {Timers}
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- G16H 20/13: delivered from dispensers
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- A61B 2560/028: Arrangements to prevent overuse, e.g. by counting the number of uses
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2016/0027: {pressure meter}
- A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor
- A61M 2205/18: with alarm
- A61M 2205/332: Force measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/583: by visual feedback
- A61M 2205/587: Lighting arrangements
- A61M 2205/8206: battery-operated
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

An adherence-monitoring and tracking device captures usage of a metered dose inhaler (MDI). The device includes an enclosure for enclosing a metered dose inhaler (MDI), and an electro-mechanical system forming a part of enclosure to sense and log the operation of the MDI. The electro-mechanical system includes at-least one transducer to capture one or more parameters pertaining to an operation of the MDI by the user. A microcontroller processes the captured parameters, and an output-unit renders data pertaining to operation of the MDI.

## Claims

### Claim 1

An adherence-monitoring and tracking device for capturing usage of a metered dose inhaler (MDI), the device comprising:
an enclosure configured to enclose the MDI; and
an electro-mechanical system forming a part of the enclosure configured to sense and log an operation of the MDI, said electro-mechanical system comprising:
a microcontroller;
at least one transducer configured to capture one or more parameters pertaining to the operation of the MDI by a user, wherein the microcontroller is configured to process said captured one or more parameters at a periodic sampling interval of less than 10 milliseconds, wherein the microcontroller is configured to process the capture one or more parameters received from said at least one transducer during the operation of the MDI to ascertain:
a) a number of steps undertaken during an inhalation maneuver by the user;
b) shaking of the MDI before usage;
c) dislodgement of an actuator cap from the MDI;
d) occurrence of exhalation before inhalation;
e) inhalation for a certain duration before and after generation of spray; and
f) restoration of the actuator at the MDI, wherein the microcontroller is further configured to process the captured one or more parameters received from said one or more transducers to derive an inhalation-profile of the user; and to identify a triggering flow-rate based on the inhalation-profile, and wherein the microcontroller is further configured to determine at least one error of the operation of the MDI due to execution of one or more parameters of parameters a) to f), and wherein the at least one error of the operation is triggered in response to referring said inhalation-profile; and
an output-unit configured to render data pertaining to the operation of the MDI.

### Claim 2 (depends on 1)

The device of claim 1 wherein the at least one transducer is at least one of:
a pressure sensor,
an acoustic-sensor; and
an accelerometer.

### Claim 3 (depends on 1)

The device of claim 1, wherein the microcontroller is further configured to process the captured one or more parameters received from the at least one transducer to determine one or more of:
(a) a remaining dose within the MDI; and
(b) a real-time tracking of an inhalation flow rate.

### Claim 4 (depends on 1)

The device of claim 1, wherein the microcontroller is further configured to provide a plurality of alerts to certify correctness of a user-operation of the MDI based on at least one of:
(i) the inhalation-profile of the user; and
(ii) the ascertained parameters a) to f).

### Claim 5 (depends on 1)

The device of claim 1, wherein the microcontroller is configured to process the one or more parameters received from the at least one transducer during the operation of the MDI to determine one or more of:
a) orientation of the MDI;
b) timing of an actuation; and
c) an inhalation flow-rate profile captured during the operation of the device;
to thereby ascertain a correctness in coordination between the inhalation and actuation.

### Claim 6 (depends on 1)

The device of claim 1, wherein the microcontroller is further configured to:
consolidate data pertaining to one or more of:
a) the dose-schedule,
b) a historical adherence of the user to the dose-schedule, and
c) a pre-stored medical-prescription for the user;
synchronize the consolidated data periodically with an external-storage;
capture data pertaining to an inhalation-maneuver as part of a forthcoming dose in the dose-schedule; and
depict adherence of the user to the dose-schedule as a percentage and/or absolute number as a function of time and/or a drug prescribed.

### Claim 7 (depends on 6)

The device of claim 6, wherein the output-unit triggered by the microcontroller is configured to render one or more of:
a number of dosages undertaken by the user;
an indicator of valid-coordination between actuation and the inhalation-maneuver during the usage of the MDI;
a first set of alerts labelling the inhalation-maneuvers as valid or invalid during the usage of the MDI;
a third type of alerts during a non-usage of the MDI device; and
a fourth type of alerts in respect of fitness of an assembly of the MDI.

### Claim 8 (depends on 1)

A method of capturing usage of a metered dose inhaler (MDI) with the adherence-monitoring and tracking device of claim 1, the method comprising:
providing the adherence-monitoring and tracking device of claim 1;
enclosing the MDI;
sensing and logging the operation of the MDI, by capturing the one or more parameters pertaining to the operation of the MDI by the user and processing said captured one or more parameters; and
rendering the data pertaining to the operation of the MDI.

### Claim 9

An adherence-monitoring and tracking device for capturing usage of a metered dose inhaler (MDI), the device comprising:
an enclosure for accommodating the MDI, wherein the enclosure comprises:
a hollow cylindrical-portion configured to receive the MDI;
a foldable-flap integral to the cylindrical-portion from a first end configured to cover a top portion of the MDI; and
a plurality of magnetic-contacts configured to latch a second end of the flap to the cylindrical-portion; and
an electro-mechanical system forming a part of the enclosure, and configured to capture an operation of the MDI and electronically render data thereof, the electro-mechanical system comprising:
a microcontroller;
at least one transducer configured to capture one or more parameters pertaining to the operation of the MDI by a user, wherein the microcontroller is configured to process said captured one or more parameters at a periodic sampling interval of less than 10 milliseconds, wherein the microcontroller is configured to process the captured one or more parameters received from said at least one transducer during the operation of the MDI to ascertain:
a) a number of steps undertaken during an inhalation maneuver by the user;
b) shaking of the MDI before usage;
c) occurrence of exhalation before inhalation;
d) inhalation for a certain duration before and after generation of spray; and
e) restoration of an actuator of the MDI, wherein the microcontroller is further configured to process the captured one or more parameters received from said one or more transducers to derive an inhalation-profile of the user; and to identify a triggering flow-rate based on the inhalation-profile, and wherein the microcontroller is further configured to determine at least one error of the operation of the MDI due to execution of one or more parameters of parameters a) to f), and wherein the at least one error of the operation is triggered in response to referring said inhalation-profile.

### Claim 10 (depends on 9)

A method of capturing usage of a metered dose inhaler (MDI) with the adherence-monitoring and tracking device of claim 9, comprising:
providing the adherence-monitoring and tracking device of claim 9;
accommodating the MDI within the hollow cylindrical-portion of the enclosure;
covering the top portion of the MDI with the foldable-flap flap;
latching the second end of the flap to the cylindrical-portion with the plurality of magnetic-contacts; and
capturing the operation of the MDI and electronically rendering the data thereof.

### Claim 11

An adherence-monitoring and tracking device for capturing usage of a metered dose inhaler (MDI), the device comprising:
a housing configured to accommodate the MDI defined by an assembly of a canister and a mouth-piece, wherein the housing comprises:
an elongated hollow-block open at a bottom of the housing configured to accommodate a canister of the MDI; and
a cover hinged at the bottom of the hollow-block, wherein said hinged cover is rotatable to act as a removable-lid at the bottom of the hollow-block and thereby selectively cover a mouthpiece linked to the canister accommodated in the hollow-block; and
an electro-mechanical system supported within the housing, and configured to capture an operation of the MDI and electronically-render data associated thereto, the electro-mechanical system comprising:
a microcontroller;
at least one transducer configured to capture one or more parameters pertaining to the operation of the MDI by the user, wherein the microcontroller is configured to process said captured one or more parameters at a periodic sampling interval of less than 10 milliseconds, wherein the microcontroller is configured to process the captured one or more parameters received from said at least one transducer during the operation of the MDI to ascertain:
a) a number of steps undertaken during an inhalation maneuver by the user;
b) shaking of the MDI before usage;
c) dislodgement of an actuator cap from the MDI;
d) occurrence of exhalation before inhalation;
e) inhalation for a certain duration before and after generation of spray; and
f) restoration of an actuator of the MDI, wherein the microcontroller is further configured to process the captured one or more parameters received from said one or more transducers to derive an inhalation-profile of the user; and to identify a triggering flow-rate based on the inhalation-profile, and wherein the microcontroller is further configured to determine at least one error of the operation of the MDI due to execution of one or more parameters of parameters a) to f), and wherein the at least one error of the operation is triggered in response to referring said inhalation-profile.

### Claim 12 (depends on 11)

The device of claim 11, wherein a top of the hollow-block is configured to act as a guide for allowing the user to impose downward-push to the canister for operating the MDI.

### Claim 13 (depends on 11)

The device of claim 11, wherein the hollow-back comprises at least one of:
a set of internal ribs configured to rigidly accommodate the MDI; and
a set of external ribs configured to allow a grip.

### Claim 14 (depends on 11)

The device of claim 11, further comprising:
a display connected to the electro-mechanical system and supported at an external surface of the hollow-block and configured to electronically render data and alerts; and
one or more illuminators connected to the electro-mechanical system and supported at the external surface of the hollow-block to provide visible-alerts.

### Claim 15 (depends on 11)

The device of claim 11, further comprising:
a lock configured to latch the cover with the hollow-block to thereby cause a rigid-accommodation of the mouth-piece within the cover during non-usage of the MDI, wherein the lock comprises flexible flaps.

### Claim 16 (depends on 11)

A method of capturing usage of a metered dose inhaler (MDI) with the adherence-monitoring and tracking device of claim 11, the method comprising:
providing the adherence-monitoring and tracking device of claim 11;
accommodating the MDI within the housing;
accommodating the canister of the MDI in the elongated hollow-block;
rotating the cover to act as the removable-lid at the bottom of the hollow-block and thereby selectively covering the mouth-piece linked to the canister accommodated in the hollow-block; and
capturing the operation of the MDI and electronically rendering the data thereof.