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-10384031-B1
Publication Date
2019-08-20
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 provides a system for safely delivering nitric oxide (NO) to a recipient using a NO2-to-NO reactor cartridge. A gas source supplies a gas comprising NO2 to a gas conduit, where the reactor cartridge converts the NO2 gas delivered to an inlet end to an outgoing NO gas exiting at an outlet end, and a delivery conduit directs the outgoing NO gas from the reactor cartridge to the recipient.
Safety is managed by monitoring how much NO2 gas is delivered to the reactor cartridge and by using computer control to stop flow when a calculated usage value reaches a predetermined threshold. The system includes a flow meter connected to the inlet end of the reactor cartridge and gas conduit to monitor the amount of NO2 gas delivered, and a computer receives electronic signals from the flow meter and generates an actuating signal to a valve to close and stop the flow of gas to the recipient when the usage value reaches the threshold.
The invention further describes cartridge and sensing information for safety management, including storage of cartridge data on a non-transient computer readable medium and comparison of usage data with an expected lifetime of the reactor cartridge to prevent an operational state when limits are reached. The document also describes containment and leak-related safety using an outer housing and an internal absorbent volume, with optional color change indicators based on interaction between color agents and NO2.
Claims Coverage
The independent claim provides a computer-controlled gas delivery system with an NO2-to-NO reactor cartridge, flow metering, and automated valve shutoff based on a calculated usage value compared to a predetermined threshold. The dependent claim set identifies additional inventive features for cartridge status and lifetime lockout and for NO2 leak or unsafe-condition monitoring and containment.
Computer-controlled NO2 delivery monitoring and valve shutoff
A system in which a computer receives electronic signals from a flow meter to calculate a usage value for comparison with a predetermined threshold value and generates an actuating signal to a valve to close and stop flow of gas to the recipient when the usage value reaches the threshold value.
Flow-meter usage value compared to a predetermined threshold
Monitoring the amount of NO2 gas delivered to the reactor cartridge with a flow meter and calculating a usage value for comparison with a predetermined threshold value to determine when to actuate the valve to stop gas flow.
NO2-to-NO reactor cartridge conversion in an inlet-to-outlet delivery path
Using a NO2-to-NO reactor cartridge connected to and in fluid communication with the gas conduit so that the reactor cartridge converts NO2 gas delivered to an inlet end into outgoing NO gas exiting at an outlet end.
Cartridge installation detection gating an operational state
Including a cartridge installation detector in electronic communication with the computer that identifies when the reactor cartridge is properly coupled and preventing the gas delivery system from entering an operational state until an actuating signal is received from the detector.
Inoperable or lifetime-limited cartridge lockout using stored expected lifetime
Receiving or storing usage data and preventing the gas delivery system from entering an operational state when stored usage data equals or exceeds a stored average expected lifetime of the reactor cartridge.
Overall, the claims focus on converting NO2 to NO using a reactor cartridge while ensuring safe delivery through flow-based usage calculation and threshold-driven valve shutoff, augmented by cartridge status checks and operational lockout based on stored cartridge lifetime information, with further safety refinements described in dependent aspects.
Stated Advantages
Stops and prevents delivery of gas to the recipient when a calculated usage value reaches a predetermined threshold.
Facilitates safe operation by preventing entry into an operational state when a reactor cartridge is not properly coupled.
Facilitates safe operation by preventing entry into an operational state when stored usage data equals or exceeds a stored average expected lifetime of the reactor cartridge.
Supports containment/reactivity by using an internal absorbent volume sufficient to react with material potentially released from the gas source.
Provides a visual indication of interaction between absorbents and NO2 via color change of a color agent.
Determines presence of an unacceptable level of NO2 in the gas being directed to the recipient using an NO2 sensor in association with the delivery conduit.
Documented Applications
Safely delivering nitric oxide (NO) to a recipient for inhalation therapy using NO2-to-NO reactor cartridge systems, including management of reactor exhaustion and NO2 breakthrough and related cartridge failure modes.
Use in connection with chronic pulmonary conditions identified in the document, including COPD, IPF, pulmonary hypertension, and CF.
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