Enhanced performance verification port for therapeutic gas delivery
Inventors
Acker, Jaron M. • Falligant, John C. • 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-10543325-B2
Publication Date
2020-01-28
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 patent describes a therapeutic gas delivery system that confirms proper functioning by coupling an attachable therapeutic gas source to a gas supply subsystem and purging a gas delivery subsystem including one or more flow control channels. The validation includes pressurizing the gas supply subsystem to a pressure above atmospheric pressure and monitoring pressure behavior over a predetermined time period to support alarm generation when pressure changes outside expected ranges are detected.
The system further uses delivery flow sensors and confirmatory flow sensors within flow control channels to detect discrepancies in measured gas flow rate. It also monitors downstream from a shut off valve, verifies that no flow is detected by one or more flow sensors during an initial phase, and provides an alert when flow is detected despite the downstream shutoff valve being closed.
The patent also incorporates reading information associated with the therapeutic gas source, including identity, concentration, and/or expiration date, and verifying that the attached therapeutic gas source matches the correct associated information. The downstream shutoff valve remains closed until that verification is completed.
Claims Coverage
The provided material includes two independent claims. Across the claims, the inventive features focus on pressure monitoring and downstream flow sensor verification, with gas source information verification described in related material.
Pressure monitoring alarm during purge pressurization
Pressurizing the gas supply subsystem to a pressure above atmospheric pressure, monitoring the pressure between the connection valve and the closed shut off valve with a gas pressure sensor for a predetermined time period, and presenting an alarm if the pressure between the connection valve and the closed shut off valve decreases or increases more than an expected amount over the predetermined time period.
Delivery-vs-confirmatory flow discrepancy alarm
Opening a shut off to deliver a flow of therapeutic gas from a gas supply subsystem to a gas delivery subsystem comprising one or more flow control channels having at least one shut off valve, at least one delivery flow sensor, and at least one confirmatory flow sensor to purge the gas supply subsystem and at least one of the one or more flow control channels; and presenting an alarm when there is a discrepancy between a gas flow rate measured by at least one delivery flow sensor and a gas flow rate measured by at least one confirmatory flow sensor in a first flow control channel.
Downstream no-flow verification with alert on detected flow
Maintaining a shutoff valve downstream from the therapeutic gas source in a closed state, verifying that no flow is detected by one or more flow sensors downstream from the shutoff valve, determining if flow is detected by one or more flow sensors downstream from the shutoff valve, and providing an alert if flow is detected by one or more flow sensors downstream from the shutoff valve.
Downstream shutoff valve gating by therapeutic gas source information
Reading information associated with a therapeutic gas source to determine its identity, concentration, and/or expiration date and verifying that the therapeutic gas source mated with a therapeutic gas supply subsystem matches the correct identity, concentration, and/or expiration date; and keeping the downstream shutoff valve in a closed state until the correct identity, concentration, and/or expiration date of the therapeutic gas is verified.
The claim coverage centers on confirming proper functioning through pressure monitoring during purge pressurization, flow confirmation using delivery flow sensors versus confirmatory flow sensors, downstream no-flow verification that triggers an alert if flow is detected, and therapeutic gas-source information verification before downstream flow is allowed.
Stated Advantages
Provides an alarm if monitored pressure changes more than an expected amount over a predetermined time period.
Presents an alarm when there is a discrepancy between delivery flow sensor measurements and confirmatory flow sensor measurements.
Provides an alert if flow is detected downstream from a shutoff valve that is maintained in a closed state.
Verifies therapeutic gas source identity, concentration, and/or expiration date before allowing downstream flow by keeping the downstream shutoff valve closed until verification is completed.
Documented Applications
Therapeutic gas delivery system pre-use and initial verification by confirming proper functioning through coupling a therapeutic gas source, purging the gas supply and flow control channels, monitoring pressure for expected behavior, comparing delivery and confirmatory flow sensing, and verifying downstream no-flow with alerting.
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