Systems and method for delivery of therapeutic gas to patients, in need thereof, receiving breathing gas from a ventilator that varies at least pressure and/or flow using enhanced therapeutic gas (NO) flow measurement

Inventors

Acker, Jaron M.Tolmie, Craig R.

Assignees

Mallinckrodt Pharmaceuticals Ireland Ltd

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Publication Number

US-11623054-B2

Patent

Publication Date

2023-04-11

Expiration Date


Abstract

Provided herein are systems and methods for delivery of therapeutic gas to patients, in need thereof, by receiving breathing gas from a high frequency ventilator using at least enhanced therapeutic gas (e.g., nitric oxide, NO, etc.) flow measurement. At least some of these enhanced therapeutic gas flow measurements can be used to address some surprising phenomenon that may, at times, occur when wild stream blending therapeutic gas into breathing gas a patient receives from a breathing circuit affiliated with a high frequency ventilator. Utilizing at least some of these enhanced therapeutic gas flow measurements the dose of therapeutic gas wild stream blended into breathing gas that the patient receives can at least be more accurate and/or under delivery of therapeutic gas into the breathing gas can be avoided and/or reduced.

Core Innovation

The invention provides a nitric oxide delivery system for delivering therapeutic gas into breathing gas in an inspiratory limb of a patient breathing circuit affiliated with a high frequency ventilator or ventilation techniques that provide reverse and/or oscillations in inspiratory pressure or flow. The system includes at least one control valve for providing a flow of nitric oxide gas, an injector module coupled to the inspiratory limb, and a therapeutic gas inlet in the injector body configured to enable injection of nitric oxide gas into patient breathing gas flowing through the inspiratory limb openings.

The delivery system incorporates at least one NO flow sensor in fluid communication with the therapeutic gas inlet and a control system operable to receive flow information from the NO flow sensor. The control system is operable to detect use of the high frequency ventilator and to handle flow sensor interpretation when high frequency ventilator operation produces reverse and/or oscillatory inspiratory pressure or flow, including identifying the flow information as missing and interpolating the missing flow information and/or identifying the flow information as reverse flow.

A further aspect provides a nitric oxide gas source, at least one control valve, an injector module, and a conduit operable to provide nitric oxide gas to the therapeutic gas inlet. The system uses at least one bi-directional NO flow sensor capable of measuring flow in a forward direction and in a reverse direction through the therapeutic gas inlet, and a control system receives bi-directional flow information including forward flow information and reverse flow information.

Claims Coverage

The independent claims describe two nitric oxide delivery systems, each with an injector module and NO flow sensing/control, with two inventive features focused on handling high frequency ventilator-induced reverse or oscillatory behavior.

Detecting high frequency ventilator use and interpolating missing or reverse NO flow

A nitric oxide delivery system comprising at least one control valve for providing a flow of nitric oxide gas, an injector module having an injector body with first and second openings configured to couple the injector module to the inspiratory limb, a therapeutic gas inlet configured to receive the flow of nitric oxide gas and enable injection into patient breathing gas in the inspiratory limb, at least one NO flow sensor in fluid communication with the therapeutic gas inlet, and a control system operable to detect use of the high frequency ventilator and to identify flow information as missing and interpolate the missing flow information and/or identify the flow information as reverse flow.

Bi-directional NO flow sensing to provide forward and reverse flow information

A nitric oxide delivery system comprising a nitric oxide gas source, at least one control valve for providing a flow of the nitric oxide gas, an injector module with an injector body having first and second openings configured to couple the injector module to the inspiratory limb, a therapeutic gas inlet configured to receive the flow of the nitric oxide gas and enable injection into patient breathing gas in the inspiratory limb, a conduit operable to provide the flow of the nitric oxide gas to the therapeutic gas inlet, at least one bi-directional NO flow sensor capable of measuring flow in a forward direction and in a reverse direction through the therapeutic gas inlet, and a control system in communication with the at least one bi-directional NO flow sensor to receive bi-directional flow information comprising at least forward flow information and reverse flow information.

Across the independent claims, the core claim coverage centers on controlled injection of nitric oxide into an inspiratory limb using an injector module and NO flow sensing, combined with control logic that accounts for high frequency ventilator-induced reverse or oscillatory behavior by detecting ventilator use and addressing missing and reverse flow, or by using a bi-directional NO flow sensor to provide forward and reverse flow information.

Stated Advantages

Supports correction of misleading apparent NO flow associated with high-frequency ventilator vibrations/oscillations and valve actuation that can be falsely interpreted as NO flow.

Enables handling of missing flow information by interpolation.

Enables identification and handling of reverse flow in flow information.

Provides forward and reverse flow information using a bi-directional NO flow sensor.

Documented Applications

Delivering therapeutic nitric oxide gas into breathing gas in an inspiratory limb of a patient breathing circuit affiliated with a high frequency ventilator or ventilation techniques that provide reverse and/or oscillations in inspiratory pressure or flow.

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