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

Inventors

Allum, ToddAguirre, JoeyCipollone, JosephEghbal, DariusKapust, GregoryWondka, Anthony

Assignees

Breathe Technologies Inc

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Publication Number

US-11154672-B2

Patent

Publication Date

2021-10-26

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 non-invasive open-airway ventilation (NIOV) using a non-sealing nasal interface in fluid communication with a ventilator. An outer tube has an entrainment aperture open to ambient air at a proximal end and an outlet at a distal end, and a nozzle delivers gas from the ventilator into the outer tube while enabling ambient air entrainment through the distal gas opening.

The arrangement forms a negative-pressure region at the entrainment port that draws ambient air, while interface geometry creates a positive-pressure region downstream toward the distal end gas opening to increase airway/lung pressure and support ventilation. The document describes the delivery architecture including a wearable ventilator module, a gas delivery circuit with manifolds, nozzles, and entrainment apertures, and optional humidification.

Open-airway pressure sensing is described using a pressure sensing port and sensors in positive-pressure zones. The system further addresses inspiratory/expiratory synchronization and cycling, including amplitude modulation, ramping, apnea-triggering, OFF-ON modes, sleep apnea operation with sensing and feedback, and sound-reduction concepts for the interface and gas flow paths designed to reduce turbulence.

Claims Coverage

The provided independent claims define three related ventilation system and interface structures that share a common gas-delivery concept using an outer tube with a proximal entrainment aperture open to ambient air and a nozzle delivering ventilator gas into the outer tube. Across the independent claims, the inventive features focus on nozzle placement relative to the entrainment aperture and the structural interface for nasal/open-airway ventilation.

Ventilator nozzle disposed completely proximal to the entrainment aperture

A ventilation system comprising a ventilator and a patient ventilation interface in fluid communication with the ventilator, where the patient ventilation interface has an outer tube with an outlet at a distal end and an entrainment aperture open to ambient air at a proximal end, and a nozzle for delivering gas from the ventilator into the outer tube, the nozzle disposed completely proximal to the entrainment aperture.

Nozzle disposed completely proximal to the entrainment aperture in a patient ventilation interface

A patient ventilation interface comprising an outer tube having an outlet at a distal end and an entrainment aperture open to ambient air at a proximal end, and a nozzle for delivering gas from a ventilator into the outer tube, the nozzle disposed completely proximal to the entrainment aperture.

Nozzle equidistantly positioned between proximal and distal ends of the entrainment aperture

A ventilation system comprising a ventilator and a patient ventilation interface in fluid communication with the ventilator, where the patient ventilation interface has an outer tube with an outlet at a distal end and an entrainment aperture open to ambient air at a proximal end, and a nozzle for delivering gas from the ventilator into the outer tube, the nozzle disposed equidistantly between a proximal end and a distal end of the entrainment aperture.

The claim coverage centers on ventilation and open-airway interfaces that entrain ambient air through a proximal entrainment aperture while delivering ventilator gas through an outer tube via a nozzle, with key structural positioning constraints: the nozzle is completely proximal to the entrainment aperture in two independent claims or equidistantly positioned between proximal and distal ends of the entrainment aperture in one independent claim.

Stated Advantages

Allows ambient breathing and mobility while providing ventilatory support via increased airway/lung pressure.

Reduces work of breathing (WOB) compared with conventional ventilation or oxygen therapy.

Improves tidal volume and efficiency compared with conventional ventilation or oxygen therapy.

Documented Applications

Sleep apnea treatment operation using sensing and feedback with the described open-airway ventilation approach.

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