Systems and methods for delivery of therapeutic gas
Inventors
Acker, Jaron M. • Milsap, Jeff • Roehl, Robin • Schmidt, Jeffrey • Tolmie, Craig R.
Assignees
Mallinckrodt Pharma IP Trading DAC • Therakos Inc • INO Therapeutics LLC • Mallinckrodt Critical Care Finance Inc
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Publication Number
US-10576225-B2
Publication Date
2020-03-03
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 relates to an electronically controlled gas blending device and a therapeutic gas delivery system that use a feedback loop to form and maintain a set dose of therapeutic gas. The device includes a flow control channel in fluid communication with a therapeutic gas supply, a blending junction, inlet flow sensors, and secondary subsystem flow sensors arranged in fluid communication with a secondary subsystem flow control valve. A therapeutic gas delivery system controller is electrically connected with at least one secondary subsystem flow control valve and the at least one secondary subsystem flow sensor to form the feedback loop.
In operation, the controller receives a set dose of therapeutic gas from a primary gas delivery subsystem and receives a flow value from one or more inlet flow sensors. The controller calculates a flow rate of the therapeutic gas through the secondary subsystem flow sensors to provide a dose of the therapeutic gas exiting the blending junction, and compares the dose exiting the blending junction to the set dose. This architecture is implemented so the feedback loop maintains the set dose based on the relationship between the set dose and the calculated exiting dose.
The claimed system further incorporates a secondary subsystem shut-off valve and secondary subsystem flow control valve arranged in series, with failure-signal-driven valve transitioning to maintain delivery during primary failure. Additional aspects include pressure fluctuation detection via an outlet pressure sensor and use of alarm generation to alert a user when flow values from sensor sets are not about the same. A breathing circuit with an injector module is also described as a context in which the secondary gas delivery subsystem provides therapeutic gas to avoid sudden changes in dose.
Claims Coverage
The provided material includes three independent claims. Across these independent claims, the core inventive features center on sensor-based dose verification through a secondary sensor-driven feedback loop and, in the system claim, failure-handling valve arrangements to maintain delivery.
Secondary subsystem feedback loop for dose verification
The therapeutic gas delivery system controller forms a feedback loop by receiving a set dose from a primary gas delivery subsystem and a flow value from inlet flow sensors, calculating a flow rate through two or more secondary subsystem flow sensors to provide a dose exiting the blending junction, and comparing the exiting dose to the set dose.
Maintaining set dose using series secondary shut-off and secondary flow control
The therapeutic gas delivery system includes a secondary subsystem with a secondary flow control channel in fluid communication with a secondary subsystem flow control valve and a secondary subsystem shut-off valve arranged in series; the controller receives the set dose from the primary gas delivery subsystem and is in electrical communication with at least the secondary subsystem flow control valve and the secondary subsystem flow sensor to form a feedback loop that maintains the set dose.
Low pressure O2/air inlet blending with series inlet flow sensors
The device includes one or more low pressure inlets configured to connect to a gas supply comprising O2 and/or air from a wall source and/or pressurized cylinder, with two or more inlet flow sensors arranged in series with each other and connected to a blending junction feeding a flow control channel; the controller receives the set dose from a primary gas delivery subsystem, receives a flow value from at least one of the two or more inlet flow sensors, calculates a flow rate through at least two secondary subsystem flow sensors to provide a dose exiting the blending junction, and compares the dose exiting the blending junction to the set dose.
Together, the independent claims define a sensor-driven feedback loop in which secondary subsystem flow sensors are used by a therapeutic gas delivery system controller to calculate a dose exiting a blending junction and compare it to a set dose. One independent claim further specifies secondary valve series arrangement to support maintaining delivery during failures, and another independent claim specifies low pressure O2/air inlet sources and series-arranged inlet flow sensors feeding the blending junction.
Stated Advantages
Maintains the set dose from the primary gas delivery subsystem using a feedback loop.
Avoids sudden changes in dose in connection with a breathing circuit and an injector module.
Detects and alerts via an alarm when flow values from sensor sets are not about the same.
Detects pressure fluctuations at the blending junction using an outlet pressure sensor.
Avoids pressure surges from the inlet(s) to the inlet flow sensor(s) by opening an over-pressure valve at a predetermined pressure.
Documented Applications
Therapeutic gas delivery in a breathing circuit including an injector module connected to a respirator and outlet.
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