Systems and methods for delivery of therapeutic gas
Inventors
Acker, Jaron M. • Milsap, Jeff • Roehl, Robin • Schmidt, Jeffrey • Tolmie, Craig R.
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-12226572-B2
Publication Date
2025-02-18
Expiration Date
Abstract
Therapy gas delivery systems that provide run-time-to-empty information to a user of the system and methods for administering therapeutic gas to a patient. The therapeutic gas delivery system may include a gas pressure sensor attachable to a therapeutic gas source that communicates therapeutic gas pressure data to a therapeutic gas delivery system controller, a gas temperature sensor positioned to measure gas temperature in the therapeutic gas source that communicates therapeutic gas temperature data to the therapeutic gas delivery system controller, at least one flow controller that communicates therapeutic gas flow rate data to the therapeutic gas delivery system controller, at least one flow sensor that communicates flow rate data to the therapeutic gas delivery system controller, and at least one display that communicates run-time-to-empty to a user of the therapeutic gas delivery system. The therapeutic gas delivery system controller of the system includes a processor that executes an algorithm to calculate the run-time-to-empty from the data received from the gas pressure sensor, temperature sensor, flow controller and flow sensor, and directs the result to the display.
Core Innovation
The invention provides a method of providing therapeutic gas from a secondary delivery subsystem by detecting a problem with a primary gas delivery system configured to deliver a therapeutic gas flow. Upon detecting the problem, therapeutic gas flow control is automatically switched to a flow control channel of the secondary delivery subsystem. The flow control channel receives the therapeutic gas flow and is in fluid communication with a secondary shut off valve, a secondary flow control valve, a secondary delivery flow sensor, and a secondary confirmatory flow sensor.
The method also switches a flow regulating valve to deliver the therapeutic gas to a primary outlet, a low pressure outlet, and an injector module, where the flow regulating valve is at a blending junction and is in fluid communication with the flow control channel. The invention grounds switching and validation on performance verification involving redundant bidirectional flow sensors and threshold comparisons among sensor outputs, including agreement checks and confirmation of proper valve switching using decreases in upstream and downstream flow rate.
For therapeutic gas such as NO, the method includes automated handling of therapeutic-gas source concentration changes and cylinder/source identification with acceptance/rejection and shutoff valve control. It performs ratio-metric NO concentration validation using cylinder concentration, a measured NO flow, an injector module flow, and a calculated NO concentration to triangulate sensor calibration, while supporting failover, replacement, service actions, run-time-to-empty logic, alarm logic, and fail-safe automatic cut-over to backup sources when problems are detected.
Claims Coverage
The independent claims cover detecting a problem with a primary gas delivery system and automatically switching therapeutic gas flow control to a secondary delivery subsystem, and switching through a blending junction and a flow regulating valve that provides therapeutic gas to a primary outlet, a low pressure outlet, and an injector module. The claim set further includes secondary sensor-based dose verification, problem detection categories, pressure fluctuation monitoring, and overpressure surge avoidance via an overpressure valve.
Automatic switching to a secondary delivery subsystem with confirmatory sensors
Automatically switching therapeutic gas flow control to a flow control channel of the secondary delivery subsystem, wherein the flow control channel is operable to receive the therapeutic gas flow and is in fluid communication with a secondary shut off valve, a secondary flow control valve, a secondary delivery flow sensor, and a secondary confirmatory flow sensor.
Blending-junction flow regulating valve delivering to outlet and injector module
Switching a flow regulating valve to deliver the therapeutic gas to a primary outlet, a low pressure outlet, and an injector module, wherein the flow regulating valve is at a blending junction and is in fluid communication with the flow control channel.
Problem detection in a primary gas delivery system
Detecting a problem with a primary gas delivery system configured to deliver a therapeutic gas flow, including loss of communication with the primary gas delivery system, failure in one or more flow control channels of the primary gas delivery system, failure at a gas analyzer of the primary gas delivery system, or a power failure of the primary gas delivery system.
Set dose comparison using exiting dose at the blending junction
Receiving a set dose of therapeutic gas, obtaining flow values from the secondary sensors, calculating a flow rate for gas exiting the blending junction, and comparing the exiting dose to the set dose.
Calculated therapeutic-gas dose using known concentration plus low-pressure gas amounts
Calculating a therapeutic gas dose using a known concentration of the therapeutic gas from a therapeutic gas source and determining low pressure oxygen and/or air amounts and therapeutic gas flow amounts to the blending junction based on secondary delivery and/or secondary confirmatory flow sensor information.
Pressure fluctuation detection communicated to the secondary delivery subsystem controller
Communicating pressure values from a pressure sensor to a secondary delivery subsystem controller and detecting pressure fluctuations in the pressure sensor.
Overpressure valve opening to avoid pressure surges
Opening an overpressure valve in fluid communication with the primary outlet at a predetermined pressure to avoid pressure surges.
Overall, the claim coverage centers on detecting problems in a primary gas delivery system and automatically switching therapeutic gas flow control to a secondary delivery subsystem that uses secondary shutoff and flow-control components and secondary delivery and confirmatory flow sensors. The switched flow is delivered through a blending junction using a flow regulating valve to a primary outlet, a low pressure outlet, and an injector module, with additional features including set-dose comparison, concentration-based dose calculation, pressure fluctuation monitoring, and overpressure surge avoidance.
Stated Advantages
Enables therapeutic gas delivery by automatically switching flow control to a secondary delivery subsystem when a problem is detected in the primary gas delivery system.
Uses secondary delivery and confirmatory flow sensors as part of the secondary flow control arrangement.
Supports delivery of therapeutic gas to a primary outlet, a low pressure outlet, and an injector module through a blending junction.
Provides dose control by comparing an exiting dose at the blending junction to a set dose.
Avoids pressure surges by opening an overpressure valve at a predetermined pressure.
Detects specific primary-system failure modes including loss of communication, flow-control channel failure, gas analyzer failure, and power failure.
Enables failover, replacement, and service actions based on validation and failure detection while maintaining therapeutic-gas delivery control.
Documented Applications
Therapeutic gas delivery in an inhaled therapeutic nitric oxide delivery system context, including primary/secondary delivery with automatic cut-over and run-time-to-empty (RTE) and alarm logic for gas sources.
Use in providing therapeutic gas from a secondary delivery subsystem in an assist breathing apparatus and/or ventilator breathing circuit context where breathing-gas flow direction and sensor agreement are verified.
NO therapeutic gas concentration validation and monitoring using cylinder concentration, measured NO flow, and a calculated NO concentration to support sensor calibration triangulation.
During-use performance verification for therapeutic gas delivery using threshold-based agreement checks among redundant bidirectional flow sensors and confirmatory checks of switching via upstream and downstream flow decreases.
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