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 Pharmaceuticals Ireland Ltd

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Publication Number

US-11998689-B2

Patent

Publication Date

2024-06-04

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 therapeutic gas delivery system that confirms proper functioning of gas delivery and injection module operation. It includes an inlet port, a low pressure outlet port in fluid communication with the inlet port, and an injection module operable to be received at the low pressure outlet port. A low pressure gas supply provides a flow of breathing gas at a breathing gas flow rate.

The system uses a low pressure delivery flow sensor and a low pressure confirmatory flow sensor to measure the breathing gas flow rate, with the sensors in fluid communication with the inlet port and the low pressure outlet port. The injection module includes an injection module delivery flow sensor and an injection module confirmatory flow sensor to measure the breathing gas flow rate, with those sensors in fluid communication with the low pressure outlet port.

A controller determines if one measured breathing gas flow rate differs from another measured breathing gas flow rate by greater than a threshold amount, using two or more of the low pressure confirmatory flow sensor, the low pressure delivery flow sensor, the injection module confirmatory flow sensor, and/or the injection module delivery flow sensor. The invention further includes pressure monitoring during purge, verification of downstream no-flow conditions, and alerts based on detected discrepancies or unexpected pressure changes.

Claims Coverage

The document includes three independent claims. Across these independent claims, the inventive features focus on multi-point flow sensing with threshold-based disagreement determination, gas supply subsystem pressure monitoring with expected-amount change alarms, and purge/verification logic that maintains a downstream shutoff closed and alerts when flow is detected.

Multi-point breathing gas flow confirmation with threshold comparison

Determine if one of the measured breathing gas flow rates differs from any one of the other measured breathing gas flow rates by greater than a threshold amount, wherein the flow rate is measured at two or more of the low pressure confirmatory flow sensor, the low pressure delivery flow sensor, the injection module confirmatory flow sensor, and/or the injection module delivery flow sensor.

Gas delivery subsystem purge and expected pressure-change alarming

Present 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.

Purging with therapeutic gas and downstream no-flow verification with alert

One or more flow sensors down stream from the shutoff valve are verified that no flow has been detected; and an alert is provided if flow is detected by one or more flow sensors down stream from the shutoff valve.

The independent claims collectively cover confirming therapeutic gas delivery and injection module operation by comparing flow measurements at multiple locations against a threshold, monitoring pressure changes between a connection valve and a closed shutoff valve for a predetermined time period and alarming on unexpected changes, and purging delivery channels while verifying no downstream flow and providing an alert if downstream flow is detected.

Stated Advantages

Confirms proper functioning of gas delivery and injection module operation by detecting discrepancies among measured breathing gas flow rates.

Provides an alarm when pressure between a connection valve and a closed shut off valve decreases or increases more than an expected amount over a predetermined time period.

Provides an alert if flow is detected by one or more flow sensors down stream from the shutoff valve.

Documented Applications

Pre-use performance verification and performance verification during delivery for a therapeutic gas delivery system by comparing breathing-gas flow rate measurements from redundant sensors against a threshold amount.

Verification of gas delivery subsystem behavior during purge/flush and pressurization monitoring, including providing alarms based on pressure changes over a predetermined time period.

Downstream flow verification after purging by maintaining a shutoff valve in a closed state, verifying no flow detection, and providing an alert if downstream flow is detected.

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