Apparatus and method for monitoring nitric oxide delivery

Inventors

Tolmie, Craig R.Schnitman, RobertMedicis, Joseph J.Potenziano, JimAcker, JaronSchmidt, Jeffrey

Assignees

Mallinckrodt Pharmaceuticals Ireland Ltd

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Publication Number

US-12138396-B2

Patent

Publication Date

2024-11-12

Expiration Date


Abstract

Described is an apparatus for monitoring nitric oxide delivery, wherein such apparatus comprises a display that provides a visual and/or numeric indication of the calculated dose of nitric oxide. Also described is a method of monitoring nitric oxide delivery, wherein the breathing gas flow rate and therapeutic gas flow rate are measured and used to determine the calculated dose of nitric oxide, which is then displayed. In some embodiments, an alert is provided when the calculated dose rises above or falls below a predetermined level or range.

Core Innovation

The invention provides an apparatus to deliver a therapeutic gas to a patient using a therapeutic gas injector module having a first inlet in fluid communication with a therapeutic gas supply and providing a flow of nitric oxide at a therapeutic gas supply concentration, a second inlet in fluid communication with a breathing gas delivery system providing a flow of a breathing gas, and an outlet to supply a combined flow of the breathing gas and the therapeutic gas to the patient. A control circuit includes a first flow sensor to measure the flow of the breathing gas from the breathing gas delivery system and provides monitoring of delivery through estimation of a nitric oxide dose.

The control circuit comprises a backup mode in which a known constant flow of the therapeutic gas is independent of a breathing gas flow rate. In the backup mode, the apparatus delivers the known constant flow of the therapeutic gas and estimates a backup dose based on the known constant flow of the therapeutic gas and the measured flow of the breathing gas. The control circuit is operable to store a breathing gas flow rate history for use in the monitoring and estimation functions.

A display in communication with the control circuit provides the estimate of the backup dose and is further configured to display the breathing gas flow rate history comprising a peak and/or average breathing gas flow rate for a period of time. The display is also configured to display a chart and/or graphic comprising a plurality of breathing gas flow rates and a predicted dose for each of the plurality of breathing gas flow rates, thereby presenting predicted nitric oxide dose behavior as breathing gas flow rates change.

Claims Coverage

The independent claims cover two aspects: an apparatus that injects nitric oxide into a patient breathing gas stream with monitoring that estimates a backup dose independent of breathing gas flow in a backup mode; and a corresponding monitoring method that performs measurement, estimation, storing, and display of backup dose and breathing gas flow rate history. Each independent claim includes multiple inventive features, including backup-mode dose estimation using known constant therapeutic gas flow, storage of breathing gas flow history, and chart/graphic presentation of predicted dose versus breathing gas flow rates.

Therapeutic gas injector module with breathing-gas combined outlet

The apparatus includes a therapeutic gas injector module with a first inlet connected to a therapeutic gas supply providing a flow of nitric oxide at a therapeutic gas supply concentration, a second inlet connected to a breathing gas delivery system providing a flow of a breathing gas, and an outlet supplying a combined flow of the breathing gas and the therapeutic gas to the patient.

Backup mode with known constant therapeutic-gas flow independent of breathing flow

The control circuit comprises a backup mode in which a known constant flow of the therapeutic gas is independent of a breathing gas flow rate, and in the backup mode it delivers the known constant flow and estimates a backup dose based on the known constant flow of the therapeutic gas and the measured flow of the breathing gas.

Backup dose estimation display with breathing-flow history

A display provides the estimate of the backup dose and is configured to display the breathing gas flow rate history comprising a peak and/or average breathing gas flow rate for a period of time.

Chart and/or graphic of predicted dose versus breathing gas flow rates

The display is configured to display a chart and/or graphic comprising a plurality of breathing gas flow rates and a predicted dose for each of the plurality of breathing gas flow rates.

Method of monitoring delivery with backup-mode dose estimation and display

The method provides a flow of breathing gas and a flow of therapeutic gas comprising nitric oxide, measures the flow of the breathing gas, obtains a known constant flow of the therapeutic gas, receives from a user a desired delivery concentration, delivers the breathing gas and the therapeutic gas, stores a breathing gas flow rate history, estimates a backup dose via a backup mode where the known constant therapeutic gas flow is independent of breathing gas flow rate, displays the estimated backup dose, and displays the breathing gas flow rate history and a chart/graphic with predicted dose for a plurality of breathing gas flow rates.

Across the independent claims, the core coverage centers on delivering nitric oxide by injecting it into a combined breathing gas stream, measuring breathing gas flow, estimating a backup nitric oxide dose using a known constant therapeutic gas flow that is independent of breathing gas flow rate, storing breathing gas flow rate history, and displaying both the estimated backup dose and a chart/graphic mapping multiple breathing gas flow rates to predicted doses.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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