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 IP • 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-12257391-B2
Publication Date
2025-03-25
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 safety-focused systems and methods for testing reactor cartridges used to convert NO2 to NO, including determining an expected lifetime. It addresses risks associated with consumable conversion media exhaustion and cartridge failure modes that can lead to NO2 breakthrough or unsafe behavior due to channeling, cracks, and leaks. The described approach uses cartridge characterization and runtime monitoring with sensors and monitoring variables to detect or predict imminent NO2 breakthrough and to support safe operation.
A reactor cartridge construction is described that includes a conversion cartridge shell with internal space partitioned by a first retainer and a volume of consumable conversion media. A second retainer is held in position by a force-applying member, with an end of the force-applying member contacting the inlet end wall and the opposite end contacting the second retainer so that a force is applied to the consumable conversion media. The structure is configured for use in a NO gas delivery system and for reliable testing and assessment of conversion performance until NO2 is detected at the outlet.
To determine expected lifetime and manage safety during use, the invention describes measuring NO2 conversion during testing by flowing a gas containing a predetermined concentration of NO2 through an installed reactor cartridge, measuring the amount of NO2-containing gas fed with a flow meter, detecting the presence of NO2 at the outlet, and calculating the amount of NO2 converted to NO up to the time NO2 was detected using a computer. The method further includes randomly selecting a subset of assembled reactor cartridges for testing, replacing the tested cartridge with a subsequent randomly selected cartridge, and repeating until all randomly selected cartridges have been tested, with expected lifetime support and integration of cartridge identity/testing/life data via memory chips and operational interlocks.
Claims Coverage
The document includes one independent claim supported by dependent claims. The main coverage is a method that assembles reactor cartridges with a retainer/force-applying structure and consumable conversion media, and randomly selects a subset of assembled cartridges for NO2-to-NO testing in a NO gas delivery system, where NO2 breakthrough detection at the outlet is used to calculate conversion up to the time of breakthrough using a computer.
Random subset assembly and testing of reactor cartridges for expected lifetime
Randomly selecting a number of reactor cartridges from a plurality of assembled reactor cartridges, installing a randomly selected reactor cartridge into a NO gas delivery system, testing the installed reactor cartridge, and replacing the installed reactor cartridge with a subsequent randomly selected cartridge and repeating the testing process until all randomly selected reactor cartridges have been tested.
NO2-to-NO conversion testing with flow metering and outlet NO2 detection
Testing the installed reactor cartridge by flowing a gas containing a predetermined concentration of NO2 through the installed reactor cartridge, measuring the amount of NO2-containing gas fed into the reactor cartridge with a flow meter, detecting the presence of NO2 at the outlet of the reactor cartridge, and calculating the amount of NO2 converted to NO up to the time NO2 was detected at the outlet using a computer.
Cartridge internal structure with retainers and force-applying member to apply force to consumable media
Providing a plurality of conversion cartridge shells, placing a first retainer on a support within the shell to partition off a section of the internal space, introducing a volume of a consumable conversion media into at least a portion of the internal volume of the conversion cartridge, placing a second retainer within the shell held in position against the volume of consumable conversion media by a force-applying member, closing an inlet end of the conversion cartridge shell with an inlet end wall, closing an outlet end of the conversion cartridge shell with an outlet end wall, and configuring an end of the force-applying member in contact with the inlet end wall and an opposite end in contact with the second retainer so that a force is applied to the volume of consumable conversion media.
Using additional sensing to refine expected conversion and detect media conditions
Calculating how much consumable conversion media was used for each tested cartridge and averaging that media usage to calculate an average amount of NO2-to-NO conversion expected for the untested plurality of assembled conversion cartridges, and measuring H2O present in the consumable conversion media with an H2O sensor and comparing the measured amount against a predetermined acceptable range, and measuring differential gas pressure across the consumable conversion media to determine a low pressure differential indicative of channeling or a crack in the conversion media.
Storing test and lifetime conversion results on a memory chip
Affixing a memory chip with a non-transient computer readable medium configured to communicate with a computer to each conversion cartridge shell and storing the average amount of NO2 that would be converted to NO on the non-transient medium.
Overall, the claims cover a method of assembling conversion cartridge shells with consumable conversion media and a retainer/force-applying-member structure, followed by randomly selecting a subset for NO2-to-NO conversion testing in a NO gas delivery system. Conversion is determined using flow metering, outlet NO2 detection, and computer-based calculation up to the time of outlet NO2 detection, with dependent claims adding averaging for untested cartridges, memory chip storage, and H2O and differential pressure sensing to support cartridge expected lifetime and detect conditions such as channeling or cracking.
Stated Advantages
Determining an expected lifetime of reactor cartridges by calculating NO2 converted to NO up to the time NO2 was detected at the outlet.
Detecting the presence of NO2 at the outlet and calculating conversion based on outlet NO2 breakthrough time.
Estimating expected NO2-to-NO conversion for untested cartridges using an average derived from tested cartridges.
Storing computed average conversion results on a memory chip associated with the cartridge shell.
Checking consumable conversion media condition by measuring H2O and comparing to a predetermined acceptable range.
Detecting channeling or a crack in the conversion media by measuring differential gas pressure to determine a low pressure differential.
Documented Applications
Testing reactor cartridges for NO2-to-NO conversion in a NO gas delivery system, including determining expected lifetime by conducting NO2-to-NO conversion testing on randomly selected cartridges and calculating conversion up to NO2 outlet detection.
Runtime and safety monitoring and cartridge safety assessment using characterization and monitoring to detect imminent NO2 breakthrough and failure modes such as channeling, cracks, and leaks, with operational interlocks preventing operation unless the installed cartridge passes.
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