Devices and methods for delivering a substance to a body cavity
Inventors
Shahaf, Daniel • Shichor, Iris
Assignees
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Publication Number
US-11992604-B2
Publication Date
2024-05-28
Expiration Date
Abstract
The present invention provides methods and a BFS/FFS device for delivering either one or more substances within at least one body cavity, characterized by a vial comprising Vsub [ml] of said substances; said vial from a pierceable container, a blow-fill-seal and a form-fill-seal, having fluid inlet and a fluid discharging outlet of diameter D [mm], configured for placement in proximity to said body cavity; said fluid inlet configured by means of size and shape to interface in a sealable manner a puncturing member, configured to, upon coupling to said fluid inlet, piercing the same, thereby providing said substances in a fluid communication, via a valve, with a chamber configured to accept pressurized fluid at volume VPF [ml] and pressure PPF [barg]; said valve is commutable from an CLOSE to an OPEN CONFIGURATION within a short period of time, <500 milliseconds (dT); at said OPEN CONFIGURATION, said pressurized fluid flows from said chamber, via said fluid inlet, entrains said substances by one erupts via said fluid discharging outlet to within said body cavity.
Core Innovation
A device and a method deliver one or more substances within at least one body cavity using at least one pierceable vial. The vial comprises Vsub of the one or more substances and has at least one fluid inlet port of diameter Din and at least one fluid discharging outlet port of diameter Dout. The inlet port is configured by size and shape to interface with at least one puncturing member to pierce the fluid inlet port upon coupling, thereby providing the substances in fluid communication with at least one chamber configured to accept pressurized fluid at volume VPF and pressure PPF.
The pressurized fluid flows from the chamber via the fluid inlet port, entrains the one or more substances, and erupts via the fluid discharging outlet port into the body cavity in the form of aerosol. The release time of Vsub and VPF is such that dTrelease is less than 500 milliseconds. The device includes quantitative constraints on VPF, Vsub, PPF, Din and Dout, pressure velocity, and volume rate release metrics, with at least one of these conditions being held true.
A pressurized-fluid release implementation is provided using at least one plunger enclosed within the at least one chamber. The plunger comprises at least one sealing member adapted to seal the chamber and prevent flow of the pressurized fluid, such that linear movement of the plunger moves the sealing member and creates a gap through which the pressurized fluid exits the chamber. The vial is selected from a group consisting of a pierceable container, a blow-fill-seal, and a form-fill-seal, and the device placement is configured in proximity to the body cavity.
Claims Coverage
The document provides four independent claims that share the central inventive concept of piercing a pierceable vial to entrain substances with pressurized fluid and erupt the mixture as aerosol into a body cavity with dTrelease less than 500 milliseconds. Across the independent claims, the core inventive features are the coupled vial/chamber/ports configuration and the quantified short release performance constraints, with dependent refinements further specifying actuation and sealing structures.
Pierceable vial and aerosol eruption with sub-500 ms release
A device that includes at least one pierceable vial with Vsub of one or more substances, inlet and outlet ports (Din, Dout) for placement in proximity to at least one body cavity, a chamber configured to accept pressurized fluid (VPF, PPF), and a coupling arrangement where a puncturing member pierces the vial inlet port to place substances in fluid communication with the chamber; the pressurized fluid entrains the substances and erupts via the outlet port into the body cavity as aerosol, with dTrelease less than 500 milliseconds and at least one of: VPF range, Vsub range, PPF range, Din or Dout range, pressure velocity greater than specified thresholds, and volume rate release metrics greater than specified thresholds.
Base and nosepiece actuation for sub-500 ms aerosol delivery
A device comprising a base and a nosepiece, where the nosepiece includes at least one pierceable vial with Vsub and inlet/outlet ports (Din, Dout) and a nosepiece cover configured to cover at least partially the nosepiece; the base includes at least one chamber for pressurized fluid (VPF, PPF) and at least one puncturing member arranged to interface with the vial inlet port; actuation of the nosepiece cover enables piercing of the vial inlet port by the puncturing member, and releasing the pressurized fluid from the chamber via the inlet port entrains the substances and erupts via the outlet port into the body cavity as aerosol with release time dTrelease less than 500 milliseconds.
Method of piercing vial and entraining pressurized fluid for sub-500 ms aerosol release
A method for delivering one or more substances within at least one body cavity using a device by providing at least one pierceable vial with Vsub and inlet/outlet port diameters (Din, Dout), configuring the inlet port by size and shape to interface with a puncturing member so that coupling pierces the inlet port and provides substances in fluid communication with a chamber accepting pressurized fluid (VPF, PPF), and facilitating flow of the pressurized fluid from the chamber via the inlet port to entrain the substances and erupt via the outlet port into the body cavity as aerosol such that dTrelease is less than 500 milliseconds; the method further holds specified ranges/thresholds for VPF, Vsub, PPF, Din/Dout, pressure velocity, and volume rate release metrics, and includes selecting the vial from a group consisting of a pierceable container, a blow-fill-seal, and a form-fill-seal and using a plunger with a sealing member that prevents flow until a gap is created.
Method using nosepiece cover actuation with sub-500 ms aerosol eruption
A method for delivering one or more substances within at least one body cavity by providing a device comprising at least one pierceable vial with Vsub and inlet/outlet port diameters (Din, Dout) and a nosepiece cover configured to cover at least partially a nosepiece; providing the device with at least one chamber confining pressurized fluid (VPF, PPF) and at least one puncturing member with corresponding interface to the vial inlet ports; actuating the device by piercing the vial inlet ports with the puncturing member; and releasing the pressurized fluid from the chamber within a short period of time (<500 milliseconds) via the fluid inlet to entrain the substances and erupt via the fluid discharging outlet port into the body cavity such that dTrelease for Vsub and VPF is less than 500 milliseconds.
Across the independent claims, the inventive coverage centers on delivering one or more substances as aerosol into one or more body cavities by piercing a pierceable vial and entraining the substances with pressurized fluid that erupts through vial outlet port(s), with a release-time requirement of dTrelease less than 500 milliseconds, supported by specified quantitative constraints and a chamber/plunger release implementation and/or nosepiece-cover actuation structure.
Stated Advantages
Documented Applications
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