# US 11,027,077 B2 · Aerosol delivery system and method

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- Number: US 11,027,077 B2
- Document ID: US11027077B2
- Status: Granted
- Kind: B2
- Application number: 15/933,219
- Filed: 2018-03-22
- Published: 2018-09-27
- Granted: 2021-06-08
- Earliest claimed: 2017-03-23
- Assignees: Stamford Devices Limited
- Applicants: Stamford Devices Ltd.
- Inventors: Shaun Porter; Louise Sweeney; Ronan MacLoughlin; Jim Fink; Aidan Duffy; Claire Lillis; Conor Duffy; Fran Keating
- Web page: https://patentgrep.com/patent/US11027077B2

## CPC

- A61M 11/005: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 11/001: {Particle size control}
- A61M 15/0085: {using ultrasonics (spraying or atomising liquids using ultrasonic vibrations in general B05B17/06)}
- A61M 15/08: Inhaling devices inserted into the nose
- A61M 16/0003: {Accessories therefor, e.g. sensors, vibrators, negative pressure}
- A61M 16/022: {Control means therefor}
- A61M 16/026: {specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis}
- A61M 16/0465: {Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters}
- A61M 16/0488: {Mouthpieces; Means for guiding, securing or introducing the tubes (guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02)}
- A61M 16/0666: {Nasal cannulas or tubing (devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02)}
- A61M 16/0672: {Nasal cannula assemblies for oxygen therapy}
- A61M 16/0816: {Joints or connectors}
- A61M 16/12: by mixing different gases
- A61M 16/14: by mixing different fluids, one of them being in a liquid phase
- B05B 17/0646: {Vibrating plates, i.e. plates being directly subjected to the vibrations, e.g. having a piezoelectric transducer attached thereto}
- A61M 16/04: Tracheal tubes (catheters in general A61M25/00)
- A61M 16/16: Devices to humidify the respiration air {(A61M16/1045 takes precedence)}
- A61M 2016/0018: {electrical}
- A61M 2016/0021: {with a proportional output signal, e.g. from a thermistor}
- A61M 2016/0027: {pressure meter}
- A61M 2016/0033: {electrical}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2016/0042: {in the expiratory circuit}
- A61M 2202/0208: Oxygen
- A61M 2202/0488: Surfactant, e.g. for the lung
- A61M 2205/17: with redundant control systems
- A61M 2205/3303: Using a biosensor
- A61M 2205/332: Force measuring means
- A61M 2205/3327: Measuring
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3569: sublocal, e.g. between console and disposable
- 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 2209/045: for filling, e.g. for filling reservoirs
- A61M 2209/084: Supporting bases, stands for equipment
- A61M 2230/40: Respiratory characteristics
- A61M 2230/42: Rate
- A61M 2230/432: partial CO2 pressure (P-CO2)
- A61M 2230/50: Temperature
- A61M 2230/60: Muscle strain, i.e. measured on the user
- A61M 2230/63: Motion, e.g. physical activity
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- A61M 2240/00: Specially adapted for neonatal use
- B05B 12/08: responsive to condition of liquid or other fluent material {to be} discharged, of ambient medium or of target {; responsive to condition of spray devices or of supply means, e.g. pipes, pumps or their drive means}
- 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)}
- B05B: SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES (spray-mixers with nozzles B01F25/72; processes for applying liquids or other fluent materials to surfaces by spraying B05D)

## Abstract

An aerosol delivery system that includes an aerosol generator that aerosolizes a fluid for delivery to a patient as a patient inhales. The aerosol delivery system includes a pump coupled to the aerosol generator that pumps the fluid to the aerosol generator, and a breath sensor that emits a signal as the patient breathes. A controller couples to the aerosol generator, the pump, and the breath sensor. In operation, the controller receives the signal from the breath sensor, controls a flow of fluid to the aerosol generator in response to the signal, and controls the aerosol generator to start aerosolizing the fluid before the patient inhales.

## Claims

### Claim 1

An aerosol delivery system, comprising:
an aerosol generator that aerosolizes a liquid medicament for delivery to a patient as a patient inhales;
a pump coupled to the aerosol generator that pumps the liquid medicament to the aerosol generator;
a breath sensor that emits a signal as the patient breathes; and
a controller coupled to the aerosol generator, the pump, and the breath sensor, wherein the controller:
receives the signal from the breath sensor;
predicts a timing of a patient inhalation by monitoring signals from the breath sensor over one or more breath cycles of the patient;
controls a flow of liquid medicament to the aerosol generator based on the predicted timing of the patient inhalation; and
controls the aerosol generator to start aerosolizing the liquid medicament before an inhalation cycle based on the predicted timing of the patient inhalation by causing the aerosol generator to aerosolize the liquid medicament at a predetermined time prior to a predicted start of the patient inhalation, wherein the predetermined time is determined by subtracting a time period that is equal to between 1% and 30% of a predicted duration of the patient inhalation from the predicted start of the patient inhalation.

### Claim 2 (depends on 1)

The system of claim 1, wherein the breath sensor comprises one of a radar sensor, a carbon dioxide sensor, a temperature sensor, an acoustic pattern sensor, an impedance plethysmography sensor, or a respiratory inductance plethysmography sensor.

### Claim 3 (depends on 1)

The system of claim 1, wherein the pump couples to the aerosol generator with a line that is primed with the liquid medicament.

### Claim 4 (depends on 1)

The system of claim 1, wherein the aerosol generator comprises a piezoelectric actuator that expands and contracts to actuate a vibratable member which aerosolizes the liquid medicament.

### Claim 5 (depends on 4)

The system of claim 4, wherein the vibratable member is a photo-defined vibratable member capable of producing a fine particle fraction greater than 80% with particles having a diameter less than or equal to 4 microns.

### Claim 6 (depends on 1)

The system of claim 1, wherein the pump is a positive displacement pump.

### Claim 7 (depends on 1)

The system of claim 1, wherein the pump is a non-positive displacement pump.

### Claim 8 (depends on 1)

The system of claim 1, wherein the controller further controls the aerosol generator to stop aerosolizing the liquid medicament at a predefined time prior to an end of the predicted timing of the patient inhalation.

### Claim 9 (depends on 8)

The system of claim 8, wherein the predefined time is determined by subtracting a time period that is equal to between 1% and 20% of a predicted duration of the patient inhalation from the end of the predicted timing of the patient inhalation.

### Claim 10 (depends on 1)

The system of claim 1, wherein:
controlling the aerosol generator to start aerosolizing the liquid medicament comprises causing the aerosol generator to aerosolize the liquid medicament at the predetermined time prior to the predicted start of the patient inhalation; and
the controller further controls the aerosol generator to stop aerosolizing the liquid medicament at a predefined time prior to an end of the predicted timing of the patient inhalation.

### Claim 11

An aerosol delivery system, comprising:
an aerosol generator that aerosolizes a liquid medicament for delivery to a patient as a patient inhales;
a pump coupled to the aerosol generator that pumps the liquid medicament to the aerosol generator;
a flow sensor configured to sense changes in fluid flow as a patient inhales; and
a controller coupled to the aerosol generator, the pump, and the flow sensor, wherein the controller:
receives the signal from the flow sensor;
predicts a timing of a patient inhalation by monitoring signals from the flow sensor over one or more breath cycles of the patient;
controls a flow of liquid medicament to the aerosol generator based on the predicted timing of the patient inhalation; and
controls the aerosol generator to start aerosolizing the liquid medicament based on the predicted timing of the patient inhalation by causing the aerosol generator to aerosolize the liquid medicament at a predetermined time prior to a predicted start of the patient inhalation, wherein the predetermined time is determined by subtracting a time period that is equal to between 1% and 30% of a predicted duration of the patient inhalation from the predicted start of the patient inhalation.

### Claim 12 (depends on 11)

The system of claim 11, wherein the pump couples to the aerosol generator with a line that is primed with the liquid medicament.

### Claim 13 (depends on 11)

The system of claim 11, wherein the aerosol generator comprises a piezoelectric actuator that radially expands and contracts to actuate a vibratable member that aerosolizes the liquid medicament.

### Claim 14 (depends on 13)

The system of claim 13, wherein the vibratable member is a photo-defined vibratable member capable of producing a fine particle fraction greater than 80% with particles having a diameter less than or equal to 4 microns.

### Claim 15 (depends on 11)

The system of claim 11, wherein the pump is a peristaltic pump.