Clinical decision support system and methods

Inventors

Acker, JaronTolmie, Craig R.

Assignees

Mallinckrodt Pharmaceuticals Ireland Ltd

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Publication Number

US-11833299-B2

Patent

Publication Date

2023-12-05

Expiration Date


Abstract

The present invention provides clinical decision support that can be used with non-portable and portable systems when delivering and/or monitoring delivery of a therapeutic gas comprising nitric oxide to a patient. Further, clinical decision support can be used with non-portable and portable systems during delivery and/or monitoring of delivery of therapeutic gas when nebulized drugs may and/or may not be being delivered to a patient (e.g., when nebulizers are delivered upstream in the inspiratory limb of the breathing circuit, into a breathing gas delivery system, etc.).

Core Innovation

The invention relates to clinical decision support and delivery systems for nitric oxide therapeutic gas mixed with breathing gas to form a gas mixture for delivery to a patient via a nebulizer device. A control module controls the flow of therapeutic gas comprising nitric oxide, mixes it with the breathing gas, and directs the gas mixture into the nebulizer device for patient delivery. A sample block evaluates the presence and concentration of one or more of nitric oxide, oxygen and nitrogen dioxide in the gas mixture, and the system provides display functionality associated with nebulizer operation.

A nebulizer mode is activated via an option presented on the display and the system receives run information including start nebulizer mode information and duration run nebulizer mode information. The control module stores logic based information for the nebulizer mode, including the start and duration information. When the nebulizer device is in use for a duration of time based on the received duration run nebulizer mode information, the control module causes the sample block to cease evaluating the gas mixture in the nebulizer mode while continuing delivery through the nebulizer device, then returns to evaluating after the duration.

The system causes different dose/concentration information to be presented on the display depending on whether the sample block is evaluating or testing. When the sample block is not evaluating, the display presents a calculated delivery dose of nitric oxide; when the sample block is evaluating, the display presents a measured concentration of nitric oxide. The therapeutic injector module and sample block architecture supports diverting a portion of the gas mixture through a sample line for analysis and operating with a sensor to measure a flow rate of the breathing gas for calculated nitric-oxide dose or delivery concentration presentation during nebulizer mode.

Claims Coverage

The document provides three independent claims. Across these claims, the central coverage is controlled nitric-oxide therapeutic gas delivery with a nebulizer mode that selectively stops gas-mixture testing and switches the display between calculated nitric-oxide delivery dose/concentration and measured nitric-oxide concentration.

Nebulizer mode run information controlled cessation of sample block evaluation

A control module configured to store logic based information for the nebulizer mode, receive run information including start nebulizer mode information and duration run nebulizer mode information, cease evaluating the gas mixture for a duration of time while continuing to deliver the gas mixture, return to evaluating after the duration of time, and cause the display to present calculated delivery dose when the sample block is not evaluating and measured concentration when the sample block is evaluating.

Selective testing outside nebulizer mode with calculated dose presentation

A control module configured to test the gas mixture for at least one of nitric oxide concentration, oxygen concentration, and nitrogen dioxide concentration when not operating in the nebulizer mode, not to test the gas mixture when operating in the nebulizer mode for a duration of time while continuing to deliver the gas mixture, return to testing after the duration of time, and cause the display to present a calculated delivery dose of nitric oxide when the gas mixture is not being tested and a measured concentration of nitric oxide when the gas mixture is being tested.

Sample block selectively diverts gas mixture for analysis with nebulizer-mode diversion cessation

A therapeutic injector module delivering a gas mixture of breathing gas and therapeutic gas to a nebulizer device, a sample line in fluid communication with an inspiratory breathing hose and a sample block configured to selectively divert a portion of the gas mixture through the sample line and analyze one or more of concentration of nitric oxide, concentration of oxygen and concentration of nitrogen dioxide, and wherein the control module is further configured to enter a nebulizer mode in response to an input indicating that the nebulizer device is anticipated to influence the gas mixture, cause the sample block to cease diverting the portion while continuing to deliver the gas mixture to the patient, return to testing after a duration of time, and cause the display to present a calculated delivery dose of nitric oxide when the gas mixture is not being tested and a measured concentration of nitric oxide when the gas mixture is being tested.

All independent claims require nitric-oxide therapeutic gas delivery with a nebulizer mode that selectively ceases sample-block evaluation or testing for a duration and switches the display output between a calculated nitric-oxide delivery dose/concentration when not testing and a measured nitric-oxide concentration when testing. Claims 12 additionally emphasize diverting a portion of the gas mixture through a sample line for analysis using a sample block, and the system architecture includes a therapeutic injector module and sensing of breathing gas flow rates for dose or delivery concentration presentation as recited in dependents.

Stated Advantages

Documented Applications

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