# US 2022/0031973 A1 · Apparatus and Method for Producing A Flow Profile

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- Number: US 2022/0031973 A1
- Document ID: US20220031973A1
- Status: Published application
- Kind: A1
- Application number: 17/499,488
- Filed: 2021-10-12
- Published: 2022-02-03
- Earliest claimed: 2015-01-23
- Assignees: Novartis AG
- Applicants: Novartis AG
- Inventors: Peter Matthewson; Laure Mahe
- Web page: https://patentgrep.com/patent/US20220031973A1

## CPC

- A61B 5/4833: {Assessment of subject's compliance to treatment}
- A61B 7/003: {Detecting lung or respiration noise}
- A61M 15/00: Inhalators {(drug delivery in endotracheal tubes A61M16/04)}
- A61M 15/0065: {Inhalators with dosage or measuring devices (A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52)}
- A61B 5/087: Measuring breath flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2230/40: Respiratory characteristics
- 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)}

## Abstract

A method for generating a flow profile of an inhalation device is described. The method comprises the step of measuring acoustic emissions induced by inhalation flow through the inhalation device. The method further comprises the step of detecting peak frequencies in the measured acoustic emissions and generating a flow profile based on the detected peak frequencies. A corresponding device is also described.

## Claims

### Claim at position 1

1-20. (canceled)

### Claim 21

A method for detecting acoustic emissions within an inhaler device having at least one chamber through which air may pass upon inhalation by a user of the inhaler, the method comprising the steps of:
positioning an acoustic sensor and an inhaler device into spaced-apart proximity with each other, wherein said acoustic sensor is not physically coupled to the inhaler, and wherein the acoustic sensor is in electrical communication with a processor; and
measuring acoustic emissions induced by a user generating an inhalation flow movement through the inhaler device; and generating a signal indicative of said movement.

### Claim 22 (depends on 21)

The method of claim 21 wherein the signal indicative of said movement comprises a flow profile.

### Claim 23 (depends on 22)

The method of claim 22 wherein the inhalation flow movement comprises a rotational flow.

### Claim 24 (depends on 23)

The method of claim 23 wherein the flow profile comprises adherence monitoring.

### Claim 25 (depends on 21)

The method of claim 21 wherein the acoustic sensor and inhaler are spaced apart by a distance of at least 0.1 meter.

### Claim 26 (depends on 25)

The method of claim 25 wherein the acoustic sensor and inhaler are spaced apart by a distance of up to 1 meter.

### Claim 27 (depends on 21)

The method of claim 21 wherein the acoustic sensor comprises a microphone.

### Claim 28 (depends on 27)

The method of claim 27 wherein the microphone and processor are part of a mobile device.

### Claim 29 (depends on 28)

The method of claim 28 wherein the mobile device comprises a smart phone.

### Claim 30 (depends on 28)

The method of claim 28 wherein the mobile device comprises a computer.

### Claim 31

A method of training a patient in the correct use of an inhaler, the method comprising,
providing an inhaler device having at least one chamber through which air may pass upon inhalation by a patient user of the inhaler;
instructing the patient to configure the inhaler for medicament delivery;
instructing the patient to position, within 1 meter of the inhaler, a mobile device comprising an acoustic sensor, signal processing software and a processor in electrical communication with the acoustic sensor, and inhale the medicament;
measuring acoustic emissions induced by a user generating an inhalation flow movement through the inhaler device; and generating a signal indicative of said movement;
determining any portion of the flow profile that requires improvement; and
communicating said improvement to the patient.

### Claim 32

A kit comprising an inhaler and instructions for use, wherein the instructions for use comprise instructing a patient to:
configure the inhaler for medicament delivery to the patient;
position an acoustic sensor within 1 meter of the inhaler device, the acoustic sensor being in electrical communication with a processor and with signal processing software; and
inhale the medicament; and
wherein the mobile device measures acoustic emissions induced by the patient to generate an inhalation flow movement through the inhaler device; and to generate a signal indicative of said movement.

### Claim 33 (depends on 32)

The kit of claim 32 wherein the signal indicative of said movement comprises a flow profile.

### Claim 34 (depends on 33)

The kit of claim 33 wherein the flow profile comprises adherence monitoring.
