# US 2018/0021530 A1 · Aerosolization system with flow restrictor and feedback device

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- Number: US 2018/0021530 A1
- Document ID: US20180021530A1
- Status: Published application
- Kind: A1
- Application number: 15/670,981
- Filed: 2017-08-07
- Published: 2018-01-25
- Earliest claimed: 2014-07-01
- Assignees: Dance Biopharm Inc.
- Applicants: Dance Biopharm Inc.
- Inventors: Jim Fink; Lisa Molloy; Ronan McLaughlin; Claire Elizabeth Lillis; Michael Joseph Casey; John Matthew Mullins; Kieran James Hyland; Joseph Martin Grehan
- Web page: https://patentgrep.com/patent/US20180021530A1

## CPC

- A61M 15/0085: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 11/005: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 15/002: {with air flow regulating means}
- A61M 15/0021: {Mouthpieces therefor}
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2016/0027: {pressure meter}
- A61M 2016/003: {with a flowmeter}
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3382: Upper level detectors
- A61M 2205/3386: Low level detectors
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61M 2205/582: by tactile feedback
- A61M 2205/584: having a color code
- A61M 2205/587: Lighting arrangements
- A61M 2205/6018: providing set-up signals for the apparatus configuration
- A61M 2205/6054: Magnetic identification systems
- A61M 2205/6072: Bar codes
- A61M 2205/8206: battery-operated
- A61M 2206/11: Laminar flow
- 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

In one aspect, embodiments of the present invention provide an aerosolization device for ensuring proper delivery of an aerosolized medication to a user's respiratory system. The aerosolization device may include a conduit, an aerosol generator, a restrictor disposed within the conduit, and an indicator mechanism. The conduit may include a mouthpiece end by which a user may cause inspiratory flow through the conduit. The aerosol generator may include a vibratable mesh. The restrictor may define a plurality of apertures disposed along an outer periphery of the restrictor configured to provide an increase in pressure differential that varies with an inspiratory flow rate within the conduit and to provide a relatively laminar flow downstream of the restrictor compared to upstream of the restrictor. The indicator mechanism may indicate to a user a state of a parameter of the inspiratory flow relative to a predefined desired range.

## Claims

### Claim 1

A method of operating an inhaler, the method comprising:
receiving a dose of liquid medicament onto a vibratable mesh;
measuring a flowrate of air flowing through the inhaler, the flow of air resulting from an inhalation by a user of the inhaler;
actuating a vibratable element to vibrate the mesh, causing aerosolization of liquid medicament and creating a plume of aerosolized liquid medicament in the flowing air;
when the flowrate is between a first threshold value and a second threshold value greater than the first, continuing to vibrate the mesh and providing a first indication to the user of the inhaler indicating that the flowrate is in a desired range between the first and second threshold values;
when the flowrate exceeds the second threshold value, stopping vibration of the mesh and providing a second indication to the user of the inhaler indicating that the flowrate is above the desired range;
when the flowrate falls below the first threshold value during aerosolization of the liquid medicament, stopping vibration of the mesh and providing a third indication to the user of the inhaler indicating that the flowrate is below the desired range; and
after substantially the entire amount of liquid medicament received onto the mesh has been aerosolized, providing a fourth indication to the user of the inhaler indicating that dosage is complete.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first, second, third, and fourth indications are visual indications.

### Claim 3 (depends on 2)

The method of claim 2, wherein the first, second, third, and fourth indications are provided via illumination of one or more lights, and include one or more indicators selected from the group consisting of light of a particular color, a constantly-illuminated light, a flashing light, a light the flashes at different rates for different indications, and a light that changes color.

### Claim 4 (depends on 1)

The method of claim 1, wherein the first threshold value is about 7 L/min and the second threshold value is about 14 L/min.

### Claim 5 (depends on 1)

The method of claim 1, further comprising providing the third indication before the flowrate has reached the first threshold value.

### Claim 6 (depends on 1)

The method of claim 1, wherein the first indication is constantly-illuminated light of a first color, the second indication is light flashing at a first rate, the third indication is light flashing at a second rate slower than the first rate, and the fourth indication is light of a second color different from the first.

### Claim 7 (depends on 6)

The method of claim 6, wherein the first, second, third, and fourth indications are all provided by a single multi-color light emitting diode.

### Claim 8 (depends on 1)

The method of claim 1, further comprising, when aerosolization of the dose of medicament is completed during an inhalation by the user of the inhaler, delaying the fourth indication.

### Claim 9 (depends on 8)

The method of claim 8, wherein delaying the fourth indication comprises delaying the fourth indication until the end of the inhalation during which aerosolization of the dose of medicament is completed.

### Claim 10 (depends on 1)

The method of claim 1, further comprising automatically shutting off the inhaler after the aerosolization of the dose of medicament is completed.

### Claim 11 (depends on 1)

The method of claim 1, wherein more than one inhalation by the user of the inhaler is required to achieve aerosolization of substantially the entire dose of liquid medicament.

### Claim 12

A method for operating an inhaler, the method comprising:
receiving a dose of liquid medicament onto a mesh;
measuring a flowrate of air flowing through the inhaler, the flow of air resulting from an inhalation by a user of the inhaler;
actuating a vibratable element to vibrate the mesh, causing aerosolization of liquid medicament from the liquid medicament dose and creating a plume of aerosolized liquid medicament in the flowing air;
when the flowrate is between 7 L/min and 14 L/min, continuing to vibrate the mesh and constantly illuminating a light that is visible to the user of the inhaler;
when the flowrate exceeds 14 L/min, stopping vibration of the mesh and causing the light to flash.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
when the flowrate falls below 7 L/min during aerosolization of the liquid medicament, stopping vibration of the mesh and causing the light flash more slowly than when the flow rate is above 14 L/min.

### Claim 14 (depends on 13)

The method of claim 13, further comprising;
after substantially the entire amount of liquid medicament received onto the mesh has been aerosolized, generating constantly-illuminated light of a different color than when the flow rate is between 7 and 14 L/min.

### Claim 15

An aerosolization system, comprising:
a housing defining a mouthpiece and a liquid receptacle fluidly coupled to the mouthpiece, wherein the liquid receptacle defines an opening configured to receive a dosage of liquid;
an aerosol generator disposed within the housing, wherein the aerosol generator comprises:
a mesh; and
a vibratable element configured to vibrate the mesh to turn the dosage of liquid into an aerosol;
a flow sensor configured to detect a flowrate of the air through the mouthpiece;
one or more lights visible to a user of the inhaler during use;
a controller coupled to the one or more lights, the flow sensor, and the vibratable element, wherein the controller is configured to:
when the flowrate is between a first threshold value and a second threshold value greater than the first, vibrate the mesh and provide a first indication using one of the one or more lights to the user of the inhaler indicating that the flowrate is in a desired range between the first and second threshold values;
when the flowrate exceeds the second threshold value, stop vibration of the mesh and provide a second indication using one of the one or more lights to the user of the inhaler indicating that the flowrate is above the desired range;
when the flowrate falls below the first threshold value during aerosolization of the liquid medicament, stop vibration of the mesh and provide a third indication using one of the one or more lights to the user of the inhaler indicating that the flowrate is below the desired range; and
after substantially the entire amount of liquid medicament received onto the mesh has been aerosolized, provide a fourth indication to the user of the inhaler indicating that dosage is complete.

### Claim 16 (depends on 15)

The aerosolization system of claim 15, wherein the first threshold value is 7 L/min and the second threshold value is 14 L/min.

### Claim 17 (depends on 15)

The aerosolization system of claim 15, wherein the first indication is a constantly-illuminated light of a first color, the second indication is a light flashing at a first rate, the third indication is a light flashing at a second rate slower than the first rate is, and the fourth indication is a light of a second color different from the first.