Device and method for aerosolized delivery of substance to a natural orifice of the body
Inventors
Shahaf, Daniel • Shichor, Iris
Assignees
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Publication Number
US-11278682-B2
Publication Date
2022-03-22
Expiration Date
Abstract
A device for delivering a predetermined amount of a substance within at least one body cavity of a subject, where the predetermined amount is at an effective amount for treatment of obesity or binge eating disorder. The device includes (a) A volume to contain the predetermined amount of the substance. (b) A delivery end placeable in proximity to the body cavity. The delivery end is in fluid communication with the volume and comprises at least one orifice. (c) A valve mechanically connected to the volume, with at least two configurations: (i) an active configuration configured to deliver the predetermined amount of the substance; and, (ii) an inactive configuration, in which the valve prevents delivery of the predetermined amount of the substance. (d) A fluid tight chamber configured to contain a predetermined volume of pressurized gas at a predetermined pressure.
Core Innovation
The invention provides a device for delivering a predetermined amount Vsub of at least one substance within at least one body cavity of a subject, using at least one open-ended nosepiece and a pressurized-gas fluid-tight chamber. The device encloses the predetermined amount Vsub in the open-ended nosepiece, and a base confines compressed pressurized gas at a predetermined compressed volume Vgas and pressure Pgas. At least one valve in communication with the base provides an active configuration that enables delivery and an inactive configuration that prevents delivery.
In the active configuration, the device releases the predetermined volume Vgas of the pressurized gas into the open-ended nosepiece, where the pressurized gas entrains the at least one substance and exits via at least one fluid discharging outlet port into the at least one body cavity. The valve is reconfigurable from inactive to active within a predetermined period of time dt in response to activation, and the outlet port includes a diameter Dout. The pressurized-gas release is enabled by at least one sealing member adapted to seal the chamber to prevent leakage.
The disclosure also states that aerosol formation and nasal deposition are governed by the interaction of the pressurized gas, the substance, and the outlet-port geometry in proximity to a nasal cavity, including deposition behavior reaching olfactory epithelium and the brain. It characterizes aerosol/plume and particle-size distributions and relates delivery properties to device parameters, including plume angle θ, DV50/DV90, and particle velocity.
Claims Coverage
The provided excerpt contains two independent claims, covering a device and a method for delivering a predetermined amount or volume into at least one body cavity using a reconfigurable valve, an open-ended nosepiece with a fluid discharging outlet port, and a pressurized-gas chamber. Across these independent claims, the inventive features focus on inactive and active valve configurations, a sealing member, and linear movement of an air chamber gate within a predetermined period of time dt.
Pressurized-gas nosepiece delivery with reconfigurable inactive/active valve
A device comprising at least one open-ended nosepiece enclosing a predetermined amount Vsub and a base with at least one chamber confining compressed pressurized gas at a predetermined compressed volume Vgas and pressure Pgas, where at least one valve has an active configuration enabling delivery of Vsub by release of the pressurized gas and an inactive configuration preventing delivery. The valve is reconfigurable from inactive to active within a predetermined period of time dt, in response to activation, such that Vgas is released, enters the open-ended nosepiece, entrains the substance, and exits via at least one fluid discharging outlet port into the body cavity.
Fluid-tight sealing chamber with air chamber gate linear valve actuation
The device further includes at least one sealing member adapted to seal the chamber containing Vgas at the predetermined pressure Pgas to prevent leakage. The base comprises an air chamber gate interconnected with the sealing member, and the valve is reconfigurable from inactive to active by linear movement of the air chamber gate, which moves the sealing member from its position and removes the sealing, allowing Vgas to exit the chamber, enter the open-ended nosepiece, and entrain Vsub for delivery.
Reconfigurable valve delivery method by predetermined time dt
A method of delivering a predetermined volume Vsub of at least one substance within at least one body cavity, comprising providing a device with at least one open-ended nosepiece enclosing the predetermined volume Vsub, a base with at least one chamber confining pressurized gas at predetermined compressed volume Vgas and pressure Pgas, and at least one valve with active and inactive configurations. The method includes placing the open-ended nosepiece in proximity to the body cavity and reconfiguring the valve to release the pressurized gas and entrain the substance so that Vsub and Vgas are released through the discharging outlet port to the body cavity within a predetermined time dt_deliver.
Gate-based chamber opening via sealing-member removal
The method further includes providing the at least one valve with at least one sealing member adapted to seal the chamber containing Vgas and prevent leakage, providing the base with an air chamber gate interconnected with the sealing member, and performing reconfiguration from inactive to active by linear movement of the chamber gate such that the sealing member is moved from its position and the sealing is removed, thereby allowing Vgas to exit the chamber, enter the open-ended nosepiece, and entrain Vsub for delivery.
Across the two independent claims, the key inventive coverage is a pressurized-gas chamber system coupled to an open-ended nosepiece with a fluid discharging outlet port, where a valve switches between inactive and active configurations within a predetermined time dt, including sealing and linear actuation via an air chamber gate.
Stated Advantages
Provides experimental and comparative evidence of deeper aerosol penetration and better targeting than commercial devices.
Achieves narrower plume angles and improved plume intensity or coverage.
Demonstrates rapid gas/drug release times and high repeatability versus commercial products.
Provides in vivo pharmacology, efficacy, and safety data for nasal delivery, including comparisons versus IV delivery.
For oil-based formulations, shows greater brain uptake and persistence versus IV controls.
Documented Applications
Nasal drug-delivery into body cavities with emphasis on deeper aerosol penetration and targeting to olfactory epithelium and brain.
Nasal delivery of insulin, including rabbit brain delivery compared to IV.
Nasal delivery of midazolam with BIS EEG sedation comparisons and seizure-suppression studies and a status epilepticus case with safety evaluations.
Nasal delivery of topiramate with pharmacokinetics and repeated-dose safety and efficacy studies in rats, including comparisons of liquid versus powder intranasal and oral.
Delivery of oil-based formulations with greater brain uptake and persistence versus IV controls.
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