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 Pharmaceuticals Ireland Ltd

Interested in licensing this patent?

MTEC can help explore whether this patent might be available for licensing for your application.

Publication Number

US-11471641-B2

Patent

Publication Date

2022-10-18

Expiration Date


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 disclosure relates to a nitric-oxide delivery system and a method of administering a therapeutic gas to a patient using a breathing circuit affiliated with a ventilator. The method measures a flow direction of a breathing gas in fluid communication with the breathing circuit, where flow is forward when flowing from the ventilator towards the patient and reverse when flowing from the patient towards the ventilator. The method opens a control valve to deliver the therapeutic gas into the breathing gas when the flow is forward, and closes the control valve to cease delivery when the flow is reverse.

To compensate for reverse-direction flow, the method determines a volume of reverse flow and determines a volume of resumed forward flow, and it compensates for reverse-direction flow based on information indicative of ventilator type. The ventilator type is determined to be a BiPAP ventilator and/or a ventilator affiliated with single limb breathing circuit, and the method compensates for flow in the reverse direction based on whether the ventilator is determined to be the BiPAP ventilator and/or the ventilator affiliated with single limb breathing circuit. The system further includes receiving information indicative of ventilator type, determining the ventilator type, and compensating the reverse-direction flow accordingly.

A bidirectional breathing circuit gas (BCG) flow sensor is used to measure breathing gas flow in both the forward direction and the reverse direction. The disclosed approach supports compensating based on reverse-flow volume and resumed forward-flow volume, including dead-space-based compensation conditions, and it can optionally condition delivery during reverse flow on whether carbon dioxide is present in at least part of the reverse flow. The architecture includes an injector module, an injector body coupled to the breathing circuit, a therapeutic gas inlet, a control valve, a control module, and optionally a CO2 sensor and monitoring/user interface components.

Claims Coverage

The partial content provides two independent claims, covering (i) a method for NO therapeutic gas delivery with reverse-flow detection/compensation and ventilator-type conditioning, and (ii) a nitric oxide delivery system architecture with a bi-directional BCG flow sensor and control logic that compensates reverse flow based on ventilator type. Across the families, the claims specify multiple inventive features that control when to open/close a control valve, determine forward and reverse volumes, and optionally gate delivery based on carbon dioxide content and dead space volume comparisons.

Bidirectional flow direction detection with valve gating for nitric oxide delivery

Measuring a flow direction of a breathing gas through and/or in fluid communication with a breathing circuit affiliated with a ventilator, opening a control valve of a nitric oxide delivery system to deliver nitric oxide when the flow is forward, and closing the control valve to cease delivery when the flow is in the reverse direction.

Reverse-flow and resumed forward-flow volume compensation conditioned on ventilator type

Determining a volume of reverse flow and determining the breathing gas resumed flow in the forward direction and a volume of resumed forward flow, receiving information indicative of ventilator type, determining the ventilator type wherein the ventilator type is a BiPAP ventilator and/or a ventilator affiliated with single limb breathing circuit, and compensating for flow in the reverse direction based on if the ventilator is determined to be the BiPAP ventilator and/or the ventilator affiliated with single limb breathing circuit.

Injector module with bi-directional BCG flow sensor and control module for reverse-flow compensation

Providing an injector module for delivering a therapeutic gas into a breathing gas in a breathing circuit, the injector module comprising an injector body coupled to the breathing circuit, a therapeutic gas inlet to enable injection of the therapeutic gas, at least one bi-directional breathing circuit gas (BCG) flow sensor capable of measuring breathing gas flow in a forward direction and in a reverse direction, a control valve in communication with the therapeutic gas inlet, and a control module in communication with the BCG flow sensor and the control valve that determines a volume of forward flow and a volume of reverse flow, receives information indicative of ventilator type, determines the ventilator type, and compensates for the flow in the reverse direction based on the ventilator type.

Ventilator-type determination for BiPAP and/or single limb breathing circuit

Receiving information indicative of ventilator type, determining the ventilator type based on the received information, wherein the ventilator type is determined to be a BiPAP ventilator and/or a ventilator affiliated with single limb breathing circuit.

Collectively, the independent claims cover NO delivery in breathing circuits by detecting forward versus reverse flow and controlling a nitric oxide control valve accordingly, then compensating reverse-direction delivery using forward/resumed forward and reverse flow volumes with ventilator-type determination for BiPAP and/or single limb breathing circuits. The system claim additionally requires a specific architecture including an injector module, a control valve, and a bi-directional BCG flow sensor coupled to a control module that performs ventilator-type-based reverse-flow compensation.

Stated Advantages

Compensating for flow in the reverse direction so nitric oxide delivery occurs only when appropriate resumed forward flow is determined.

Avoiding over delivery/overdosing and under delivery by using reverse-flow and resumed-forward-flow volume compensation, including dead-space-based compensation conditions.

Conditionally gating delivery during reverse flow based on whether reverse flow contains carbon dioxide.

Fast and low-resistance bidirectional BCG flow sensing to support reverse/forward flow determination for compensation.

Documented Applications

Use in ventilator breathing circuits, including single-limb BiPAP circuits, for administering a therapeutic gas comprising nitric oxide while handling reverse-flow phenomena through bidirectional flow detection and compensation.

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.