Device to deliver a predetermined amount of a substance to a natural orifice of the body
Inventors
Shahaf, Daniel • Shichor, Iris
Assignees
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Publication Number
US-11383048-B2
Publication Date
2022-07-12
Expiration Date
Abstract
The present invention provides a device for delivering a predetermined amount of at least one substance to a body orifice of a subject; comprising: a. a container for containing said at least one substance; b. a delivery end for placement in proximity to said orifice, said delivery end being in fluid communication with said container; c. a valve mechanically connectable to said container, characterized by at least two configurations: (i) an ACTIVE CONFIGURATION in which said valve enables delivery of predetermined amount of said substance from said container to said body orifice via said delivery end; and, (ii) an INACTIVE CONFIGURATION, in which said valve prevents delivery of said predetermined amount of said substance from said container to said body orifice; d. a trigger mechanism adapted to reconfigure said valve from said INACTIVE CONFIGURATION to said ACTIVE CONFIGURATION, and vice versa; e. a fluid tight chamber.
Core Innovation
The invention describes a membrane-free delivery device for delivering a predetermined amount of at least one substance to a body orifice of a subject, with delivery via a delivery end positioned in proximity to the body orifice and in fluid communication with a membrane-free container. The device includes a mechanically connectable valve that has at least two configurations, an ACTIVE CONFIGURATION that enables delivery and an INACTIVE CONFIGURATION that prevents delivery. A trigger reconfigures the valve between the INACTIVE CONFIGURATION and the ACTIVE CONFIGURATION within a predetermined period of time in response to activation of the trigger.
A fluid tight chamber contains a predetermined amount of a gas at a predetermined pressure, and, once the valve is reconfigured from INACTIVE to ACTIVE, the gas is configured to entrain the at least one substance and deliver the entrained substance via the delivery end to a predetermined site of delivery within the body orifice. In the INACTIVE CONFIGURATION, the valve seals the container and the fluid tight chamber so that, when reconfigured to the ACTIVE CONFIGURATION, a bypass is created in the container aligned with a gap in the fluid tight chamber, providing a passage for the pressurized gas to exit the fluid tight chamber, enter the container, and entrain the substance.
The description further characterizes delivery using a predetermined-pressure gas carrier and a trigger-reconfigurable mechanically active valve/nozzle delivery arrangement for nasal/natural-orifice delivery, including nozzle extensions and expandable seals to aid positioning and reduce leakage/discomfort. It also supports capsule configurations in which the substance is held in one or multiple compartments for multi-compartment sequential or simultaneous mixing/reaction, and includes mixing mechanisms configured to entrain the substance into the gas, mix the substance, react the substance, or any combination of these actions.
Claims Coverage
The independent claims cover three device and method frameworks (device, method, syringe-like device) and a further method formulation. Across these independent claims, the main inventive features recur as a membrane-free container with a delivery end, a mechanically reconfigurable all-or-nothing valve with ACTIVE/INACTIVE configurations reconfigured by a trigger within a predetermined period of time, and a fluid tight chamber holding a predetermined amount of gas at a predetermined pressure that entrains and delivers a predetermined amount of substance via a bypass/gap arrangement without rupture of any membrane.
Membrane-free valve-triggered gas entrainment delivery device
A device comprising a membrane-free container, a delivery end in fluid communication with the container, a mechanically connectable valve with at least two configurations comprising an ACTIVE CONFIGURATION enabling delivery and an INACTIVE CONFIGURATION preventing delivery, and a trigger configured to reconfigure the valve from INACTIVE to ACTIVE within a predetermined period of time in response to activation of the trigger.
Fluid tight chamber delivering predetermined-pressure gas that entrains substance
A fluid tight chamber configured to contain a predetermined amount of a gas at a predetermined pressure, wherein the gas, once the valve is reconfigured from INACTIVE to ACTIVE, is configured to entrain the at least one substance and deliver the substance entrained in the gas via the delivery end to a predetermined site of delivery within the body orifice.
Bypass/gap alignment without membrane rupture using an all-or-nothing valve
The valve in the INACTIVE CONFIGURATION is adapted to seal the container and the fluid tight chamber, such that when the valve is reconfigured to the ACTIVE CONFIGURATION a bypass is created in the container aligned with a gap in the fluid tight chamber to provide a passage for the pressurized gas to exit the fluid tight chamber and enter the container and entrain the substance to be delivered to the body orifice, wherein the entering is provided without any rupture of any membrane; the valve is an all-or-nothing valve such that in the ACTIVE CONFIGURATION the valve is fully opened to enable a full release of the gas and the at least one substance to the body orifice.
Trigger-reconfigured valve delivery method with pressurizing and entrainment
A method comprising providing a device having a membrane-free container, a delivery end in fluid communication with the container, a valve with ACTIVE and INACTIVE configurations, a trigger configured to reconfigure the valve within a predetermined period of time in response to activation, and a fluid tight chamber configured to contain a predetermined amount of a gas at a predetermined pressure; emplacing the at least one substance in the fluid tight chamber, placing the valve in the inactive configuration, pressurizing the fluid-tight chamber with the gas to the predetermined pressure, activating the trigger to reconfigure the valve to the ACTIVE CONFIGURATION thereby entraining the at least one substance and enabling delivery via the delivery end to a predetermined site of delivery within the body.
Syringe-like membrane-free device with charger-gas entrainment and bypass/gap sealing
A syringe-like device comprising a delivery end, a membrane-free container in fluid communication with the delivery end, a valve with ACTIVE and INACTIVE configurations, a trigger configured to reconfigure the valve from INACTIVE to ACTIVE for a predetermined period of time in response to activation, and a fluid tight chamber in fluid communication with the valve; a charger configured to provide a predetermined amount of the gas at the predetermined pressure; wherein once the valve is reconfigured to ACTIVE the gas entrains the at least one substance and delivers it via the delivery end; the valve in the INACTIVE CONFIGURATION seals the container and the fluid tight chamber such that when reconfigurable to ACTIVE a bypass is created aligned with a gap in the fluid tight chamber to permit passage of pressurized gas for exiting the fluid tight chamber, entering the container and entraining the substance without any rupture of any membrane; wherein the valve is an all-or-nothing valve fully opened in ACTIVE to enable full release of gas and the at least one substance to the body orifice.
Syringe-like method with predetermined-period trigger activation and all-or-nothing release
A method comprising steps of providing a syringe-like device with a delivery end, a membrane-free container in fluid communication with the delivery end, a valve with ACTIVE and INACTIVE configurations reconfigured by a trigger within a predetermined period of time in response to activation, and a fluid tight chamber plus a charger providing predetermined amount of gas at a predetermined pressure; emplacing the predetermined amount of the at least one substance in the container; placing the valve in the inactive configuration; pressurizing the fluid tight chamber with the gas; activating the trigger and reconfiguring the valve to the ACTIVE CONFIGURATION thereby entraining the at least one substance and delivering it via the delivery end to a predetermined site of delivery within the body; wherein the INACTIVE configuration seals the container and the fluid tight chamber so that in ACTIVE a bypass aligns with a gap to permit passage of the pressurized gas into the container without any rupture of any membrane; wherein the valve is an all-or-nothing valve such that reconfiguring to ACTIVE results in a fully opened valve enabling full release of gas and the at least one substance to the body.
Across independent claim sets, the claimed subject matter centers on a membrane-free container and delivery end; a mechanically reconfigurable all-or-nothing valve providing ACTIVE/INACTIVE delivery control; a trigger that switches the valve within a predetermined period; and a fluid tight, predetermined-pressure gas chamber whose pressurized gas entrains the predetermined substance using a bypass/gap arrangement that enables gas entry without rupture of any membrane, resulting in delivery to a predetermined site within a body orifice.
Stated Advantages
Enables delivery of a predetermined amount of at least one substance to a predetermined site of delivery within a body orifice.
Prevents delivery in the INACTIVE configuration using a valve that seals the container and the fluid tight chamber.
Enables full release of gas and the at least one substance by using an all-or-nothing valve in the ACTIVE configuration.
Allows pressurized gas to enter the container via a bypass/gap passage without any rupture of any membrane.
Documented Applications
Delivery to nasal/natural-orifice sites, including proximity to a nostril and delivery within nasal-like models (e.g., mucosal layers/olfactory epithelium).
Aerosol deposition studies in nasal-like experimental models, with reported influence of pressure, air volume, and timing on aerosol deposition depth and distribution.
Delivery evaluation using nasal-like models with imaging/measurement including SPECT-CT and aerosol characterization such as droplet size and distribution.
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