Aerosolization system with flow restrictor and feedback device

• US 10,471,222 B2
• Filed: 06/18/2015
• Issued: 11/12/2019
• Est. Priority Date: 07/01/2014
• Status: Active Grant

• Current Assignee: Aerami Therapeutics, Inc. (Dance Biopharm Holdings, Inc.)
• Original Assignee: Dance BioPharm Incorporated (Dance Biopharm Holdings, Inc.)
• Inventors: Fink, Jim, Molloy, Lisa, MacLoughlin, Ronan, Lillis, Claire, Casey, Michael, Mullins, John, Hyland, Kieran, Grehan, Joe
• Primary Examiner(s): Carter, Kendra D
• Assistant Examiner(s): Paciorek, Jonathan S
• Application Number:
  US14/743,763
• Publication Number:
  US 20160001018A1
• Time in Patent Office: 1,608 Days
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/003 with a flowmeter
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/584 having a color code
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2206/11 Laminar flow

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

1. An aerosolization device for ensuring proper delivery of an aerosolized medication to a user'"'"'s respiratory system, the aerosolization device comprising:

a conduit having a mouthpiece end by which a user may cause an inspiratory flow through the conduit;

an aerosol generator in communication with the conduit and comprising a vibratable mesh;

a restrictor disposed within the conduit, wherein the restrictor defines a plurality of apertures disposed along an outer periphery of the restrictor, the plurality of apertures being configured to;

provide an increase in pressure differential that varies with an inspiratory flow rate within the conduit; and

provide a relatively laminar flow downstream of the restrictor compared to upstream of the restrictor; and

an indicator mechanism that indicates to a user a state of a parameter of the inspiratory flow relative to a predefined desired range, wherein indicating to the user the state of the parameter of the inspiratory flow relative to the predefined desired range comprises;

the indicator mechanism providing a first indication when the parameter of the inspiratory flow is within the predefined desired range;

the indicator mechanism providing a second indication when the parameter of the inspiratory flow is within a predefined secondary range, wherein the predefined secondary range extends above and below the predefined desired range and is within an operating range of the aerosol generator; and

the indicator mechanism providing a third indication when the parameter of the inspiratory flow is outside of both the predefined desired range and the predefined secondary range.

2. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user'"'"'s respiratory system according to claim 1, wherein the indicator mechanism comprises:

at least one selection from a group consisting of a light, a digital readout, a speaker, or a vibration-generating device.

3. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user'"'"'s respiratory system according to claim 1, wherein the parameter of the inspiratory flow comprises:

the inspiratory flow rate within the conduit.

4. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user'"'"'s respiratory system according to claim 3, wherein:

the predefined desired range of the inspiratory flow rate is between 5 and 14 liters per minute (L/min).

5. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user'"'"'s respiratory system according to claim 1, the aerosolization device further comprising:

an input device for receiving and setting the predefined desired range of the parameter of the inspiratory flow.

6. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user'"'"'s respiratory system according to claim 1, wherein:

the restrictor is configured such that fluid only flows through the plurality of apertures disposed along the outer periphery.

7. An aerosolization device for ensuring proper delivery of an aerosolized medication to a user'"'"'s respiratory system, the aerosolization device comprising:

a conduit having a mouthpiece end by which a user may cause an inspiratory flow through the conduit;

an aerosol generator in communication with the conduit and comprising a vibratable mesh;

a restrictor disposed within the conduit, wherein the restrictor defines a plurality of apertures disposed along an outer periphery of the restrictor, the plurality of apertures being configured to;

provide an increase in pressure differential that varies with an inspiratory flow rate within the conduit; and

provide a relatively laminar flow downstream of the restrictor compared to upstream of the restrictor; and

an indicator mechanism that indicates to a user a state of a parameter of the inspiratory flow relative to a predefined desired range, wherein indicating to the user the state of the parameter of the inspiratory flow relative to the predefined desired range comprises;

the indicator mechanism providing a first indication when the parameter of the inspiratory flow is within the predefined desired range;

the indicator mechanism providing a second indication when the parameter of the inspiratory flow is within a predefined secondary range, wherein the predefined secondary range extends above and below the predefined desired range and is within an operating range of the aerosol generator; and

the indicator mechanism providing a third indication when the parameter of the inspiratory flow is outside of both the predefined desired range and the predefined secondary range,

wherein the vibratable mesh produces a plume of aerosolized medicament within the relatively laminar flow when the inspiratory flow rate is within an operating range of the aerosol device.

8. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user'"'"'s respiratory system according to claim 7, wherein:

the restrictor is configured such that fluid only flows through the plurality of apertures disposed along the outer periphery.

9. The aerosolization device for ensuring proper delivery of an aerosolized medication to a user'"'"'s respiratory system according to claim 8, wherein the parameter of the inspiratory flow comprises:

the inspiratory flow rate, and the predefined desired range is the operating range of the inspiratory flow rate.

10. The aerosolization device for ensuring proper delivery of an aerosolized medicament to a user'"'"'s respiratory system according to claim 7, wherein:

the operating range of the inspiratory flow rate is between 5 and 14 L/min.

11. A method of delivering an aerosolized medication to a user'"'"'s respiratory system, the method comprising:

sensing a state of a flow parameter of an inspiratory flow within a conduit, the conduit having a mouthpiece end by which a user may cause the inspiratory flow within the conduit;

providing an indication using an indicator mechanism of the state of the flow parameter relative to a predefined desired range, wherein providing an indication comprises;

providing a first indication when the flow parameter is within the predefined desired range;

providing a second indication when the flow parameter is within a predefined secondary range, wherein the predefined secondary range extends above and below the predefined desired range and is within an operating range of an aerosol generator; and

providing a third indication when the flow parameter is outside both the predefined desired range and the predefined secondary range; and

vibrating a mesh of the aerosol generator in communication with the conduit to aerosolize a volume of a liquid medicament to produce a plume of aerosolized medicament within the conduit when the state of the flow parameter is within a predefined desired range, wherein;

the plume of aerosolized medicament is provided within a relatively laminar flow produced by a restrictor disposed within the conduit upstream of the plume of aerosolized medicament;

the restrictor defines a plurality of apertures disposed around an outer periphery of the restrictor; and

the plume of aerosolized medicament is carried by the relatively laminar flow toward the mouthpiece end of the conduit.

12. The method of delivering an aerosolized medicament to a user'"'"'s respiratory system according to claim 11, wherein:

the predefined desired range is between 5 and 14 L/min.

13. The method of delivering an aerosolized medicament to a user'"'"'s respiratory system according to claim 11, the method further comprising:

providing an indication that the liquid medicament is ready to be aerosolized; and

providing an indication that substantially all of the liquid medicament has been aerosolized.

14. The method of delivering an aerosolized medicament to a user'"'"'s respiratory system according to claim 11, the method further comprising:

receiving an input to set the predefined desired range of the flow parameter.