Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature

Inventors

Allum, Todd • Aguirre, Joey • Cipollone, Joseph • Eghbal, Darius • Kapust, Gregory • Wondka, Anthony

Assignees

Breathe Technologies Inc

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Publication Number

US-12048813-B2

Patent

Publication Date

2024-07-30

Expiration Date


Abstract

Systems and methods may include a gas source, a gas delivery circuit, and a nasal interface allowing breathing ambient air through the nasal interface. A gas flow path through the nasal interface may have a distal gas flow path opening. A nozzle may be associated with a proximal end of the nasal interface a distance from the distal end gas flow path opening. At least a portion of an entrainment port may be between the nozzle and the distal end gas flow opening. The nozzle may deliver gas into the nasal interface to create a negative pressure area in the gas flow path at the entrainment port. The nasal interface and the nozzle may create a positive pressure area between the entrainment port and the distal end gas flow path opening. Gas from the gas delivery source and air entrained through the entrainment port may increase airway pressure or lung pressure or provide ventilatory support.

Core Innovation

The invention relates to a non-invasive open-airway nasal ventilation system that uses a non-sealing nasal interface. The nasal interface includes one or more tubular bodies that collectively define a pair of gas flow paths terminating in a pair of distal gas flow openings, and one or more nozzles deliver gas from a ventilator into the tubular bodies. Nasal cushions are attachable to the distal gas flow openings in fluid communication with the gas flow paths.

A Venturi arrangement is described with gas-flow opening geometry that creates a negative-pressure region at an entrainment port or aperture to draw ambient air into a shared gas flow path. The device design also generates a positive-pressure region downstream between the entrainment port and the distal openings so that the combined ventilator gas and entrained ambient air increases airway, upper airway, and lung pressure. Exhaled gas exits to ambient rather than through a sealed exhaust circuit.

The system includes a pair of pressure sensing lumens that each terminate in a pressure sensing port in a respective gas flow path at a location nearer to the respective gas flow opening than to the one or more nozzles. Additional embodiments are described to generate sound reduction and pressure sensing in the positive-pressure zone, including nozzle placement features, secondary exhaust or port arrangements, and an interface configuration that may include bilateral or unilateral manifolds and optional interconnecting channels and exhaust paths to reduce shearing and noise.

Claims Coverage

The partial content provides three independent claims. Across these claims, the core inventive structure is a nasal ventilation interface with tubular bodies, nozzles, distal openings with nasal cushions, and a pair of pressure sensing lumens or ports positioned nearer to the distal gas flow openings than the nozzles, with additional geometry constraints in the narrower nasal interface claim set.

Ventilator and nasal interface with tubular gas flow paths and distal openings

A ventilation system comprising a ventilator and a nasal interface in fluid communication with the ventilator. The nasal interface includes one or more tubular bodies collectively defining a pair of gas flow paths that terminate respectively in a pair of distal gas flow openings, and one or more nozzles for delivering gas from the ventilator into the one or more tubular bodies.

Nasal cushions attachable to distal gas flow openings

The nasal interface includes a pair of nasal cushions attachable respectively to the pair of distal gas flow openings and in fluid communication with the one or more gas flow paths.

Pressure sensing lumens positioned nearer distal openings than nozzles

The ventilation system includes a pair of pressure sensing lumens each of which terminates in a pressure sensing port in a respective one of the gas flow paths at a location nearer to the respective gas flow opening than to the one or more nozzles.

Nasal interface for ventilation gas with tubular bodies, nozzles, distal openings, and cushions

A nasal interface comprising one or more tubular bodies collectively defining a pair of gas flow paths that terminate respectively in a pair of distal gas flow openings, and one or more nozzles for delivering gas from a ventilator into the one or more tubular bodies. The nasal interface further includes a pair of nasal cushions attachable respectively to the pair of distal gas flow openings and in fluid communication with the one or more gas flow paths.

Pressure sensing lumens in a nasal interface positioned nearer distal openings than nozzles

The nasal interface includes a pair of pressure sensing lumens each of which terminates in a pressure sensing port in a respective one of the gas flow paths at a location nearer to the respective gas flow opening than to the one or more nozzles.

Nasal cushions having non-circular distal openings

A nasal interface where each of the nasal cushions has a non-circular opening at a distal end thereof, the nasal cushions being attachable respectively to the pair of distal gas flow openings and in fluid communication with the one or more gas flow paths.

Taken together, the independent claims cover a ventilation system or a nasal interface having tubular bodies that define paired gas flow paths terminating at paired distal gas flow openings, one or more nozzles delivering ventilation gas into the tubular bodies, a pair of nasal cushions coupling to the distal openings, and a pair of pressure sensing lumens or ports located nearer the distal openings than the nozzles; in one independent nasal interface claim set, the nasal cushions further include a non-circular opening at the distal end.

Stated Advantages

Increases airway, upper airway, and lung pressure by combining ventilator gas with entrained ambient air.

Allows the patient to breathe ambient air freely by permitting exhaled gas to exit to ambient rather than a sealed exhaust circuit.

Reduces sound through embodiments including nozzle placement and secondary exhaust or port arrangements.

Documented Applications

Sleep apnea treatment, with comparison to CPAP/BiPAP and described ramping, biofeedback, and trigger logic.

Bench or model evaluation using a lung simulator and comparisons versus closed ventilation and oxygen therapy.

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