Systems and method for delivery of therapeutic gas to patients in need thereof using enhanced breathing circuit gas (BCG) flow measurement

Inventors

Acker, Jaron M. • Tolmie, Craig R.

Assignees

Mallinckrodt Pharma IP Trading DAC • Mallinckrodt Pharmaceuticals Ireland Ltd • Therakos Inc • INO Therapeutics LLC • Mallinckrodt Critical Care Finance Inc

Abstract

The present invention generally relates to systems and method for delivery of therapeutic gas to patients in need thereof using enhanced breathing circuit gas (BCG) flow measurement. At least some of these enhanced BCG flow measurements can be used to address some surprising phenomena that may, at times, occur when wild stream blending therapeutic gas into breathing gas that a patient receives from a breathing circuit affiliated with a ventilator. Utilizing at least some of these enhanced BCG flow measurements the dose of therapeutic gas wild stream blended into breathing gas that the patient receives from a ventilator can at least be more accurate and/or over delivery of therapeutic gas into the breathing gas can be avoided and/or reduced.

Core Innovation

The invention provides a nitric oxide delivery system that includes an injector module for delivering a therapeutic gas into a breathing gas in a breathing circuit. The injector module includes an injector body with first and second openings configured to couple to the breathing circuit, and a therapeutic gas inlet configured to receive the therapeutic gas and enable injection into the breathing gas flowing through the injector module. The system further includes at least one sensor capable of measuring flow in a forward direction and in a reverse direction, and a control module in communication with the sensor(s).

The control module provides the therapeutic gas to the therapeutic gas inlet and determines a volume of forward flow and reverse flow of the breathing gas based on measurements from the sensor(s). The therapeutic gas flow is controlled by a control valve in communication with the therapeutic gas inlet. The control module compensates delivery based on the measurement from the at least one sensor such that the control module closes the control valve when the sensor measures reverse flow and opens the control valve after the sensor measures resumed forward flow.

The compensating delivery includes a condition that the resumed volume of forward flow is at least equal to the volume of reverse flow, thereby addressing over-delivery phenomena caused by reverse flow. The therapeutic gas comprises nitric oxide, and the system includes logic that uses forward/reverse flow information to control valve operation and compensate for reverse-flow volume. Additional aspects described include sensing and logic related to circuit and gas characteristics to support correct operation and handling of inappropriate conditions.

Claims Coverage

The independent claim recites a nitric oxide delivery system with an injector module and a control module that uses a forward/reverse flow sensor to determine forward and reverse flow volumes and to compensate therapeutic gas delivery by closing and opening a control valve based on reverse-flow detection and forward-flow resume. Additional dependent claim sets refine operation with added sensor inputs and decision logic for improper placement determinations, gas-type sensing/alerts, ventilator-type handling, and ratiometric delivery tied to an average flow measured by a breathing circuit gas flow sensor.

Overall, the claim set centers on bidirectional (forward/reverse) flow sensing in a breathing circuit combined with control-valve gating to stop delivery during reverse flow and resume delivery only after forward flow resumes with at least equal recovered forward volume.

Stated Advantages

Documented Applications