Inhalation device for use in aerosol therapy of respiratory diseases
Inventors
ALLOSERY, Koen • Huber, Martin • Kolb, Tobias • Müllinger, Bernhard • SCHICK, Juliane • Depla, Erik
Assignees
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Publication Number
US-10512739-B2
Publication Date
2019-12-24
Expiration Date
Abstract
An inhalation device, assembly or system can include a kit and a pharmaceutical composition. The device can be adapted for administering therapeutic aerosols to pediatric patients, including neonates, infants or toddlers. The device can further include a vibrating mesh aerosol generator that can be insertable into a flow channel of the inhalation device through a lateral opening, and a valved face mask. The device can be connectable to a gas source through which a gas, such as oxygen, can be received into the flow channel at a low flow rate.
Core Innovation
The invention relates to an inhalation device for delivering a nebulized aerosol to a patient. The device includes an aerosol generator with a vibratable mesh connected to a reservoir for a liquid to be nebulised, and a gas inlet opening shaped as a tube fitting supplies gas to a flow channel. The aerosol is delivered to the patient through a face mask.
A key structural concept is that the flow channel extends from the gas inlet opening to the aerosol inlet opening of the face mask and has a lateral opening through which the aerosol generator is at least partially inserted into the flow channel. The device is configured to avoid variable flow restriction between the gas inlet opening and the face mask aerosol inlet opening at 1 to 20 L/min, and the flow channel does not comprise a further inlet opening for receiving a gas.
The flow channel is shaped to provide laminar flow over a flow-rate range, and the design avoids a large mixing chamber to minimize channel and mask volumes. The disclosure further expands to assemblies and kits for aerosol therapy, including patient-facing valved face masks with exhalation overpressure resistance in the range from 0.5 to 5 mbar.
Claims Coverage
The independent claim coverage centers on five main inventive features: a vibratable mesh aerosol generator and reservoir; a tubefitting-shaped gas inlet opening; a valved face mask with defined exhalation overpressure resistance; a flow channel with a lateral generator insertion opening; and flow-channel limitations excluding variable flow restriction and excluding any further gas inlet. Additional refinements add laminar-flow shaping, a gas-velocity condition proximate to the lateral opening, constant-flow gas supply, and sequence-defined anti-RSV compositions.
Vibratable mesh aerosol generator and reservoir
An aerosol generator with a vibratable mesh, and a reservoir for a liquid to be nebulised, the reservoir being in fluid connection with the vibratable mesh.
Tubefitting-shaped gas inlet opening
A gas inlet opening shaped as a tube fitting.
Valved face mask with limited exhalation overpressure resistance
A face mask comprising a casing, an aerosol inlet opening, a patient contacting surface, and a one-way exhalation valve or a two-way inhalation/exhalation valve in the casing having an exhalation overpressure resistance selected in the range from 0.5 to 5 mbar.
Flow channel with lateral generator insertion and no further gas inlet
A flow channel extending from the gas inlet opening to the aerosol inlet opening of the face mask, the flow channel having a lateral opening through which the aerosol generator is at least partially inserted into the flow channel, wherein the flow channel does not comprise a further inlet opening for receiving a gas.
No variable flow restrictor for 1 to 20 L/min inspiratory flow
The inhalation device does not comprise a variable flow restrictor configured to restrict an inspiratory flow between the gas inlet opening and the aerosol inlet opening of the face mask at a flow rate of 1 to 20 L/min.
Laminar flow in the flow-channel section
A flow-channel section is shaped to effect a laminar flow when gas is conducted through the flow channel at a flow rate from 1 to 20 L/min.
Constant-flow gas supply assembly
A gas- and inhalation-device assembly that supplies gas to the flow channel at a constant flow rate of 1 to 5 L/min entering through the gas inlet opening.
Anti-RSV immunoglobulin single variable domains
A combination or kit in which anti-RSV immunoglobulin single variable domains have specified CDR1/CDR2/CDR3 amino-acid sequences, and at least one domain is selected from defined SEQ ID ranges or the polypeptide is selected from defined SEQ ID sequences.
The claims focus on a vibratable-mesh aerosol generator inserted via a lateral opening into a shaped flow channel that delivers aerosol through a valved face mask with defined exhalation overpressure resistance, while excluding variable flow restriction and excluding any further gas inlet. The refinements further narrow the device via laminar-flow shaping, a gas-velocity condition proximate to the lateral opening, constant-flow gas supply, and sequence-defined anti-RSV compositions.
Stated Advantages
The device is configured to avoid variable flow restriction between the gas inlet opening and the face mask aerosol inlet opening at 1 to 20 L/min.
The design avoids a large mixing chamber to minimize channel and mask volumes.
Documented Applications
Aerosol therapy for special populations, including pediatric patients such as neonates, infants, toddlers, and school children, including sedated or sleeping patients.
Treatment involving RSV lower respiratory tract infection, including bronchiolitis or bronchopneumonia, using anti-RSV agent pharmaceutical compositions.
Aerosol deposition evaluation by deposition modeling and an Example deposition study comparing configurations with and without additional air supply.
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