Device and method for aerosolized delivering of substance to a natural orifice of the body
Inventors
Shahaf, Daniel • Shichor, Iris • NAPCHI, David
Assignees
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Publication Number
US-11116914-B2
Publication Date
2021-09-14
Expiration Date
Abstract
A device for delivering a predetermined volume a substance within a body cavity. The device includes: at least one predefined volume sized and shaped to contain a predetermined volume the substance; a delivery end in fluid communication with a container; and at least one valve mechanically connected to the container and configurable between an active configuration in which the valve enables delivery of a volume of the substance and an inactive configuration, in which the valve prevents delivery.
Core Innovation
The invention provides an aerosol delivery device for delivering predetermined volumes or masses of at least one substance within at least one body cavity of a subject. The device uses at least one capsule sized and shaped to contain the predetermined volume or mass of the substance, and a nozzle configured for placement in proximity to the body cavity, with the nozzle in fluid communication with the capsule and comprising at least one orifice.
A mechanically connectable reconfigurable valve provides at least two configurations, including an active configuration enabling delivery and an inactive configuration preventing delivery. The valve is reconfigurable from inactive to active within a predetermined period of time dT that is less than or equal to 200 ms, and a fluid tight chamber contains a predetermined volume Vgas of pressurized gas at a predetermined pressure Pgas.
The pressurized gas is configured to entrain the at least one substance and deliver the substance via the orifice into the at least one body cavity. The device is configured to achieve a release time of substantially the entirety of the predetermined volume, dTdeliver, that is less than 500 ms, independent of the predetermined volume Vgas, the predetermined volume Vsub, and the predetermined pressure Pgas, and particles after exit from the device have a velocity in a range of about 5 m/s to 50 m/s.
Claims Coverage
The independent claims identified are clm-00001, clm-00014, clm-00022, clm-00032, and clm-00038. Together they define five inventive features centered on a capsule/nozzle/valve device and corresponding delivery methods that entrain a predetermined substance in a predetermined pressurized gas volume, then deliver through nozzle orifices within a rapid release time constraint while maintaining particle velocity and specified quantitative ranges.
Predetermined substance in capsule and nozzle orifice delivery
A device configured to deliver a predetermined volume Vsub or a predetermined mass Msub of at least one substance within at least one body cavity, using at least one capsule containing the predetermined volume or mass and a nozzle in fluid communication with the capsule, where the nozzle comprises at least one orifice and is configured for placement in proximity to the body cavity.
Reconfigurable valve switching inactive to active within dT
At least one valve mechanically connectable to the capsule having at least two configurations: an active configuration enabling delivery and an inactive configuration preventing delivery, wherein the valve is reconfigurable from the inactive configuration to the active configuration within a predetermined period of time dT that is less than or equal to 200 ms in response to activation.
Fluid tight pressurized gas chamber entraining and delivering through orifice
A fluid tight chamber configured to contain predetermined volume Vgas of pressurized gas at a predetermined pressure Pgas, wherein the pressurized gas, once the valve is reconfigured to the active configuration, is configured to entrain the at least one substance and deliver the at least one substance via the at least one orifice into the at least one body cavity.
Release time constraint dTdeliver maintained below 500 ms
A delivery configuration such that a release time of substantially the entirety of the predetermined volume of the at least one substance and the predetermined volume Vgas of the pressurized gas, dTdeliver, is less than 500 ms, and wherein the dTdeliver is maintained less than 500 milliseconds independent of the predetermined volume Vgas, the predetermined volume Vsub, and the predetermined pressure Pgas.
Particle velocity after exit about 5 m/s to 50 m/s
A delivery configuration wherein a velocity of particles of the at least one substance after exit from the device is in a range of about 5 m/s to 50 m/s.
Across the independent claims, the coverage centers on a reconfigurable valve and fluid-tight pressurized gas chamber that entrain and deliver a predetermined substance from a capsule through a nozzle with specified orifice delivery, while constraining delivery to a rapid release time and constraining particle velocity to about 5 m/s to 50 m/s.
Stated Advantages
Rapid delivery characterized by a release time dTdeliver of substantially the entirety of the predetermined substance and predetermined volume of pressurized gas that is less than 500 ms.
Delivery time robustness, maintaining dTdeliver less than 500 milliseconds independent of predetermined volume Vgas, predetermined volume Vsub, and predetermined pressure Pgas.
Delivered particles have a defined velocity range after exit of about 5 m/s to 50 m/s.
In the described examples, aerosol plume performance and penetration/coverage are characterized versus commercial devices, including droplet sizing/particle distributions and release-time advantages, and biological brain delivery evidence is provided for insulin and Midazolam.
Documented Applications
Delivering predetermined substance volumes or masses within at least one body cavity, including the nasal cavity, mouth, throat, ear, vagina, rectum, and urethra.
Nasally administering substances in connection with brain delivery evidence, including insulin and Midazolam.
Using Midazolam administration in biological contexts described as sedation/EEG normalization and seizure prevention in animal models and a human status epilepticus case study.
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