Drug delivery devices and methods for administering substances to a body cavity by heterogenous aerosolization
Inventors
Shahaf, Daniel • Shichor, Iris
Assignees
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Publication Number
US-12329902-B2
Publication Date
2025-06-17
Expiration Date
Abstract
A device for delivering a predetermined volume of a substance within at least one body cavity of a subject includes a predefined volume for containing the predetermined volume of the at least one substance. The device also includes a delivery end for placement in proximity to the body cavity where the delivery end includes at least one orifice of diameter D. The device further includes a valve mechanically connectable to the container, the valve having at least two configurations: (i) an active configuration in which the valve enables delivery of predetermined volume Vsub [ml] of the substance and, (ii) an inactive configuration, in which the valve prevents delivery of the predetermined volume Vsub [ml] of the substance from the container to the body cavity. The device also includes a fluid tight chamber configured to contain a predetermined volume Vgas [ml] of pressurized gas at a predetermined pressure, Pgas [barg].
Core Innovation
The invention relates to a device configured to deliver one or more substances within at least one body cavity of a subject, including an intranasal nose-to-brain delivery context in the nasal cavity. The device includes at least one vial having a predetermined volume Vsub of the substances, with the vial providing a fluid inlet and a fluid discharging outlet, and the fluid inlet is configured to interface in a sealable manner with a puncturing member that pierces the fluid inlet upon coupling to the fluid inlet.
The device further includes at least one valve and at least one chamber configured to accept pressurized fluid at a volume VPF and a pressure PPF. The valve is commutable from a CLOSED CONFIGURATION to an OPEN CONFIGURATION within a period of time dT of less than 500 milliseconds, and the release time dTrelease of the Vsub and the VPF is also less than 500 milliseconds. When the valve is in the OPEN CONFIGURATION, the pressurized fluid flows from the chamber via the fluid inlet and entrains the substances such that the pressurized fluid erupts via the fluid discharging outlet into the body cavity in the form of an aerosol.
The aerosol exiting the fluid discharging outlet into the body cavity forms a bi-modal spray pattern with a composition that provides a first plume angle of less than 25° in a first portion and a second plume angle of approximately 35° to 110° in a second portion. The device is also associated with a bi-modal particle-size distribution, having a first particle size peak above 100 μm and a second particle size peak below 100 μm.
The described background motivation includes dosing and reproducibility challenges and a need to reach the olfactory region efficiently for nasal administration and nose-to-brain delivery. Representative substances include saline, topiramate, midazolam, and insulin, and the document reports measured aerosol characteristics including droplet size bimodality and plume-angle/width features together with delivered dose and reproducibility against acceptance criteria.
Claims Coverage
The document includes one independent claim (clm-00001). The claim coverage centers on a valve-actuated pressurized-gas aerosol delivery device with a fast CLOSED-to-OPEN switching time and a fast release time, producing a bi-modal spray pattern with specified plume-angle portions.
Valve commutation and fast aerosol release for body cavity delivery
A device configured to deliver one or more substances within at least one body cavity using a valve commutable from a CLOSED CONFIGURATION to an OPEN CONFIGURATION within a period of time dT less than 500 milliseconds, with a release time dTrelease of Vsub and VPF less than 500 milliseconds, wherein in the OPEN CONFIGURATION pressurized fluid entrains the substances and erupts via a fluid discharging outlet into the body cavity as an aerosol.
Sealable vial puncturing interface with outlet orifice placement
At least one vial comprising a predetermined volume Vsub of the substances with a fluid inlet and a fluid discharging outlet of diameter D configured for placement in proximity to the body cavity, wherein the fluid inlet is configured by means of size and shape to interface in a sealable manner with at least one puncturing member that pierces the fluid inlet upon coupling, thereby providing the substances in fluid communication via the valve with a chamber configured to accept pressurized fluid at volume VPF and pressure PPF.
Bi-modal spray pattern with defined plume-angle portions
A composition of the aerosol exiting the fluid discharging outlet into the body cavity forms a bi-modal spray pattern having a first plume angle of less than 25° in a first portion and a second plume angle of approximately 35° to 110° in a second portion.
Bi-modal particle-size distribution peaks
A bi-modal spray pattern whose particle size distribution has a first peak above 100 μm and a second peak below 100 μm.
Pulsed entrainment emitting multiple VPF portions
A pressurized fluid entrains the substance in a pulsed manner such that a plurality of portions of VPF are emitted via the fluid discharging outlet to within the at least one body cavity.
Across the independent claim, the core inventive coverage is the combination of a sealable punctured-vial interface, valve commutation within less than 500 milliseconds with corresponding fast release time, and aerosol eruption from an orifice into a body cavity that forms a bi-modal spray pattern with defined plume-angle portions, further supported by bi-modal particle-size distribution and optionally pulsed entrainment emitting multiple VPF portions.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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