Systems and methods for manufacturing and safety of an NO2-to-NO reactor cartridge used to deliver NO for inhalation therapy to a patient
Inventors
Acker, Jaron M. • Kohlmann, Thomas
Assignees
Mallinckrodt Pharma IP Trading DAC • Mallinckrodt Pharmaceuticals Ireland Ltd • Therakos Inc • INO Therapeutics LLC • Mallinckrodt Critical Care Finance Inc
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Publication Number
US-11554242-B2
Publication Date
2023-01-17
Expiration Date
Abstract
The principles and embodiments of the present invention relate to methods and systems for safely providing NO to a recipient for inhalation therapy. There are many potential safety issues that may arise from using a reactor cartridge that converts NO2 to NO, including exhaustion of consumable reactants of the cartridge reactor. Accordingly, various embodiments of the present invention provide systems and methods of determining the remaining useful life of a NO2-to-NO reactor cartridge and/or a breakthrough of NO2, and providing an indication of the remaining useful life and/or breakthrough.
Core Innovation
The invention relates to a reactor cartridge for converting NO2 to NO for delivery to a patient using a gas delivery system. The cartridge includes an outer reactor shell with an inlet end wall and an outlet end wall that seal respective ends to form an internal volume, and an inlet and outlet that facilitate connection to first and second gas conduits while allowing gas to pass through the cartridge.
Consumable conversion media is retained within the internal volume and is configured to convert incoming NO2 gas to outgoing NO gas exiting at the outlet for delivery to the patient. The media is retained between a front end retainer positioned towards the inlet and a back end retainer positioned towards the outlet, and a force-applying member positioned between the inlet end wall and the front end retainer applies pressure to the consumable conversion media.
To support safety across cartridge life and testing conditions, the cartridge further includes a memory chip affixed to the outer reactor shell that stores identification data, testing data, and cartridge life data on a non-transient computer readable medium. A computer reads the stored data and prevents the gas delivery system from entering an operational state if the identification data, testing data, or cartridge life data exceeds stored average expected values.
Claims Coverage
The document describes one independent claim directed to a NO2-to-NO conversion reactor cartridge with consumable conversion media retention, pressure application, and a memory chip with data-based operational blocking. The independent claim includes 4 inventive features.
No2-to-no reactor cartridge with sealed inlet and outlet end walls
A reactor cartridge for converting NO2 to NO for delivery to a patient using a gas delivery system, comprising an outer reactor shell, an inlet end wall that seals the inlet end to form an internal volume, an outlet end wall that seals the outlet end to form an internal volume, and an inlet and outlet facilitating connection to gas conduits and passage of gas through the cartridge.
Consumable conversion media retained between inlet and outlet retainers
Consumable conversion media retained within the internal volume that converts incoming NO2 gas to outgoing NO gas, with a back end retainer towards the outlet to prevent media from exiting through the outlet and a front end retainer towards the inlet to prevent media from exiting through the inlet, wherein the media is retained between the front end retainer and the back end retainer.
Force-applying member applying pressure to the conversion media
A force-applying member positioned between the inlet end wall and the front end retainer to apply pressure to the consumable conversion media.
Memory chip storing cartridge data and preventing operation when exceeded
A memory chip affixed to the outer reactor shell that stores identification data, testing data, and cartridge life data on a non-transient computer readable medium, wherein a computer reads the stored data and prevents the gas delivery system from entering an operational state if the identification data, testing data, or cartridge life data exceeds stored average expected values.
Overall, the claim coverage centers on a reactor cartridge that converts NO2 to NO for patient delivery using consumable conversion media retained by front and back end retainers and compressed by a force-applying member, combined with a memory chip storing identification, testing, and cartridge life data so a computer can prevent the system from entering an operational state when stored values exceed expected criteria.
Stated Advantages
Prevents the gas delivery system from entering an operational state if identification data, testing data, or cartridge life data exceeds stored average expected identification data, testing data, or cartridge life data.
Documented Applications
NO inhalation therapy using a gas delivery system that delivers NO product gas generated by converting NO2 to NO in the reactor cartridge.
Use with ventilator/CPAP/BiPAP masks and nasal cannulas for delivering NO product gas generated by the cartridge.
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