Aerosolization system with flow restrictor and feedback device
Inventors
Fink, Jim • Molloy, Lisa • MacLoughlin, Ronan • Lillis, Claire Elizabeth • Casey, Michael Joseph • Mullins, John Matthew • Hyland, Kieran James • Grehan, Joseph Martin
Assignees
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Publication Number
US-11273271-B2
Publication Date
2022-03-15
Expiration Date
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.
Core Innovation
The invention relates to operating an inhaler by receiving a dose of liquid medicament onto a vibratable mesh and actuating a vibratable element to vibrate the mesh, thereby aerosolizing the liquid medicament. The aerosolization creates a plume of aerosolized liquid medicament in flowing air resulting from an inhalation by a user of the inhaler, and the plume includes droplets having a mean mass aerodynamic diameter between 3.5 and 5 microns and is supplied directly to a conduit through which the air flows.
The invention monitors a flowrate of air flowing through the inhaler and controls whether vibration of the mesh continues based on the relationship between the monitored flowrate and first and second threshold values. While less than substantially the entire amount of liquid medicament received onto the mesh has been aerosolized, vibration is continued when the flowrate is within a desired range between the first and second threshold values, and vibration is stopped when the flowrate exceeds the second threshold value or falls below the first threshold value during aerosolization. After substantially the entire amount of liquid medicament received onto the mesh has been aerosolized, a dosage complete indication is provided.
The invention further includes user-visible indications using light states corresponding to flow conditions and dosage completion. 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. In an aerosolization system, a restrictor plate positioned upstream of the vibratable element creates relatively laminar air flow from inhaled air so that the air flow in which the plume of aerosolized medicament is introduced is relatively laminar.
Claims Coverage
The document provides three independent claims (clm-00001, clm-00009, clm-00012). Across these claims, the coverage centers on flowrate-monitored control of mesh vibration for producing a specified droplet mean mass aerodynamic diameter plume, delivery of that plume into a relatively laminar conduit flow via a restrictor plate, and multi-state user indications via light behaviors including constant illumination, flashing at different rates, and a distinct completion color.
Flowrate-controlled vibration for mesh aerosolization within a desired range
The method includes receiving a dose of liquid medicament onto a vibratable mesh, monitoring a flowrate of air resulting from an inhalation, actuating a vibratable element to vibrate the mesh and aerosolize the liquid medicament into a plume, and while less than substantially the entire amount has been aerosolized: continuing to vibrate when the flowrate is between a first threshold value and a second threshold value; stopping vibration when the flowrate exceeds the second threshold value; and stopping vibration when the flowrate falls below the first threshold value during aerosolization.
In-range and out-of-range user indications with distinct light flashing behaviors and dosage completion
The method provides a first indication that the flowrate is in the desired range between the first and second threshold values, provides a second indication when the flowrate exceeds the second threshold value, provides a third indication when the flowrate falls below the first threshold value during aerosolization, and provides a fourth indication after substantially the entire amount of liquid medicament received onto the mesh has been aerosolized; 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.
Relatively laminar conduit flow via an upstream restrictor plate
The conduit comprises a restrictor plate positioned upstream of the vibratable element such that the air flow in which the plume of aerosolized medicament is introduced is relatively laminar.
Inhaler method operating once flowrate reaches the threshold window with continuing vibration and light behavior
The method includes receiving a dose of liquid medicament onto a mesh and monitoring a flowrate of air resulting from an inhalation; once the flowrate of air is between a first threshold value and a second threshold value, actuating a vibratable element to vibrate the mesh to aerosolize the liquid medicament and create a plume having droplets with a mean mass aerodynamic diameter between 3.5 and 5 microns, supplying the plume directly to a conduit through which the air flows and supplying the plume through a side of the flow channel.
Visual light control linked to flow exceeding the second threshold value
Subsequently, when the flowrate is between 7 L/min and 14 L/min, continuing to vibrate the mesh and constantly illuminating a light; and when the flowrate exceeds 14 L/min, stopping vibration of the mesh and causing the light to flash; wherein the conduit comprises a restrictor plate positioned upstream of the vibratable element to make the air flow relatively laminar.
Aerosolization system with restrictor plate, mesh-and-vibratable-element generator, flow sensor, and controller-driven visual indications
An aerosolization system includes a housing defining a mouthpiece and a liquid receptacle, a conduit in the mouthpiece through which air flows, a restrictor plate disposed within the conduit creating a relatively laminar flow from the inhaled air, and an aerosol generator downstream of the restrictor plate comprising a mesh and a vibratable element configured to vibrate the mesh to turn the dosage of liquid into an aerosol with droplets having a mean mass aerodynamic diameter between 3.5 and 5 microns; the aerosol is supplied directly to the relatively laminar flow within the conduit through a side of the conduit; a flow sensor monitors flowrate; one or more lights are visible to a user during use; and a controller coupled to the lights, the flow sensor, and the vibratable element is configured to provide flow-state indications while the monitored flowrate is within/above/below threshold values and to provide a dosage-complete indication after substantially all medicament received onto the mesh has been aerosolized.
Across the independent claims, the inventive subject matter combines (i) monitoring inhalation air flowrate and using that measurement to start/continue/stop vibrating a vibratable mesh during aerosolization; (ii) generating an aerosol plume with droplets having a mean mass aerodynamic diameter between 3.5 and 5 microns and supplying the plume directly to a conduit through a side of the conduit; (iii) creating relatively laminar conduit flow using an upstream restrictor plate; and (iv) providing user-visible indications using light states that vary with in-range versus above-range versus below-range flow conditions and a distinct indication when dosage is complete.
Stated Advantages
Provides user feedback indicating whether the inspiratory flow is in a desired range between a first and second threshold value, above the desired range, below the desired range, and whether dosage is complete.
Delivers a plume of aerosolized medicament into a conduit in which the air flow is relatively laminar.
Controls vibration of the vibratable mesh based on whether the flowrate is within a desired range while less than substantially the entire amount of liquid medicament received onto the mesh has been aerosolized.
Documented Applications
Operating an inhaler to aerosolize liquid medicament for inhalation by a user, including providing flow-dependent user indications and a dosage-complete indication.
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