Self-puncturing liquid drug cartridges and associated dispenser
Inventors
Stedman, Benjamin • Fink, Jim • Molloy, Lisa
Assignees
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Publication Number
US-10610651-B2
Publication Date
2020-04-07
Expiration Date
Abstract
Self-puncturing liquid drug cartridges and an associated inhaler are used to deliver one or more separate doses of an aerosolized liquid drug. A cartridge includes a needle assembly coupled to a drug container. The needle assembly includes a hollow needle and is reconfigurable from a first configuration to a second configuration upon insertion of the cartridge into the inhaler. In the first configuration, the hollow needle does not extend into the container. In the second configuration, the hollow needle extends into the container. The inhaler includes an aerosol generator that includes a vibratable membrane that aerosolizes liquid drug ejected from the cartridge for inhalation by a patient.
Core Innovation
The invention relates to a self-puncturing liquid drug cartridge and an aerosolization system using a removable liquid drug cartridge. The cartridge includes a container configured to store a liquid drug, a septum configured to seal a first end of the container, and a piston sealing a second end of the container. A reconfigurable hollow needle assembly is coupled to the first end of the container and is configured to move between a first configuration in which the hollow needle does not extend through the septum and a second configuration in which the hollow needle extends through the septum.
During reconfiguration, the hollow needle moves relative to a cap that has an aperture accommodating a portion of the hollow needle and relative movement. A guide element supports the hollow needle in a fixed position and orientation relative to the guide element and guides movement of the hollow needle relative to the container. A spring element biases the needle assembly into the first configuration in the absence of induced displacement of the container relative to the guide element. The piston is repositionable relative to the container to selectively eject a volume of the liquid drug from the container via the hollow needle.
In an aerosolization system, a housing defines a mouthpiece and includes a receptacle configured to at least partially receive the liquid drug cartridge and interface with the needle assembly such that insertion of the cartridge reconfigures the needle assembly from the first configuration to the second configuration. An aerosol generator disposed in the housing includes a vibratable membrane with a front face and a rear face, and a piezoelectric element used to vibrate the vibratable membrane. An actuator repositions the piston relative to the container to dispense a dosage of the drug via the hollow needle to the rear face of the vibratable membrane, and the housing includes a mixing chamber and air inlets to mix aerosolized drug with inhalation air using laminar airflow promoted by a restrictor array.
The disclosure further addresses microbial control between doses and user safety, including microbial ingress suppression concepts such as silver-coated conduits/needles and filters, with optional ultraviolet irradiation. Protective caps and cartridge removal/reinsertion are described as enabling cleaning access and re-priming behavior. The system also emphasizes improved dose control concepts, including priming cycles and dose metering/actuation concepts associated with piston repositioning and timing relative to aerosol generation.
Claims Coverage
The partial content includes three independent claims (cartridge, aerosolization system, and an additional cartridge configuration). Across the independent claims, the coverage centers on a reconfigurable self-puncturing needle assembly that transitions from a non-penetrating state to a penetrating state upon insertion, together with a repositionable piston that selectively ejects liquid drug through the hollow needle into an aerosol generator.
Self-puncturing needle assembly transitions from non-penetrating to penetrating through a septum
A needle assembly comprising a cap, a guide element, a spring element and a hollow needle, where the cap is coupled to a first end of the container; the needle assembly is reconfigurable between a first configuration in which the hollow needle does not extend through the septum and a second configuration in which the hollow needle extends through the septum; the hollow needle moves relative to the cap during reconfiguration; the cap has an aperture to accommodate a portion of the hollow needle and movement of the hollow needle relative to the cap during reconfiguration; the guide element supports the hollow needle in a fixed position and orientation relative to the guide element and guides movement of the hollow needle relative to the container during reconfiguration; and the spring element biases the needle assembly into the first configuration in the absence of induced displacement of the container relative to the guide element.
Repositionable piston selectively ejects liquid drug via the hollow needle
A piston sealing a second end of the container, where the piston is repositionable relative to the container so as to selectively eject a volume of the liquid drug from the container via the hollow needle.
Insertion-coupled reconfiguration interface within a housing
A housing defining a mouthpiece and including a receptacle configured to at least partially receive the liquid drug cartridge and interface with the needle assembly such that the needle assembly is reconfigured from the first configuration to the second configuration during an insertion of the cartridge into the receptacle.
Vibratable membrane aerosol generator driven by piezoelectric element
An aerosol generator disposed in the housing including a vibratable membrane having a front face and a rear face, and a piezoelectric element used to vibrate the vibratable membrane.
Actuator dispenses drug dosage via hollow needle to rear face of vibratable membrane
An actuator configured to reposition the piston relative to the container to dispense a dosage of the drug via the hollow needle to the rear face of the vibratable membrane.
Cartridge snap fit retention and sliding receptacle spring support
A cartridge in which the cap has a proximal side in which the first end of the container is received and retained via complementary snap fit features of the cap and the container; the guide element forms a receptacle in which the cap and a portion of the container are slidingly received; the spring is disposed in the receptacle; and the spring has a first end interfaced with the cap and a second end interfaced with an end wall of the guide element.
Taken together, the independent claims cover a reconfigurable hollow needle assembly that is biased into a non-penetrating configuration and transitions to a septum-penetrating configuration using a cap/guide/spring structure, and a repositionable piston that ejects a volume or dosage of liquid drug through the hollow needle, including an aerosolization system where insertion reconfigures the needle and an actuator dispenses drug to the rear face of a vibratable membrane aerosol generator.
Stated Advantages
Improved dose control, including priming cycles and metering/actuation concepts.
Microbial control between doses using concepts such as silver-coated conduits/needles and filters, with optional ultraviolet irradiation.
Reduced surface contact via laminar airflow promoted by a restrictor array.
User safety/cleaning access enabled by removable protective caps and cartridge removal/reinsertion that can re-prime the system.
Documented Applications
A self-puncturing liquid drug cartridge for use in an aerosolization system with a housing and mouthpiece for delivering aerosolized drug generated by a vibratable membrane aerosol generator.
Dose delivery operation in which cartridge insertion into a receptacle reconfigures the needle assembly and an actuator dispenses a dosage to the aerosol generator.
Microbial control between doses for repeated use of the aerosolization system.
User cleaning access and re-priming behavior via removable protective caps and cartridge removal/reinsertion.
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