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
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Publication Number
US-10265486-B2
Publication Date
2019-04-23
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 provides non-invasive open-airway nasal ventilation in which a patient breathes ambient air directly through a nasal interface that does not impede the patient from breathing ambient air directly through the nasal interface. A nozzle is positioned at a proximal end of the nasal interface at a distance from a nose, and an entrainment port is disposed substantially between the nozzle and a distal end of the nasal interface. The nozzle is delivered into the nasal interface to create a negative pressure area at the entrainment port location while the nasal interface and nozzle create a positive pressure area between the entrainment port and the distal end.
By creating the negative pressure area at the entrainment port and the positive pressure area between the entrainment port and the distal end, the combination of gas from the gas source and air entrained through the entrainment port increases airway pressure. The nasal interface and the nozzle are configured such that the patient's ambient breathing can continue through the open-airway nasal interface, while delivered gas contributes to increasing airway/lung pressure as a result of entrainment. In therapeutic implementations, substantially all exhaled gas flows through the entrainment port and virtually none flows through the gas delivery circuit, so the therapeutic level includes both ventilator-delivered gas and ambient air entrained through the aperture.
The invention further defines the gas flow path geometry and related pressure-region positioning, including a gas flow path comprising a first section that is substantially lateral-to-midline and a second section distal to the first section that is substantially inferior-to-superior, with a curve between the sections and the positive pressure area substantially generated proximal to the curve. In an embodiment directed to positioning comfort, the nasal interface includes a curved manifold with a lateral-posterior-inferior curve on each side of a midline to position the manifold where most comfortable to the patient. Additional embodiments describe pressure sensing in a positive-pressure zone within the interface to support control of therapeutic delivery.
Claims Coverage
The partial content identifies four independent method claims. Across these independent claims, the inventive features include creating negative and positive pressure regions around an entrainment port while allowing the patient to breathe ambient air directly, and delivering therapeutic gas by combining ventilator gas with ambient entrained air. In at least two independent claims, the interface configuration is specified to route substantially all exhaled gas through the entrainment port and virtually none through the gas delivery circuit.
Open-airway nasal ventilation using nozzle-created negative and interface-created positive pressure regions
A method providing a nasal interface that allows a patient to breathe ambient air through the nasal interface, providing a nozzle associated with a proximal end of the nasal interface at a distance from a nose, providing an entrainment port substantially between the nozzle and a distal end of the nasal interface, and adapting the nozzle to deliver gas into the nasal interface to create a negative pressure area in the gas flow path at the entrainment port, wherein the nasal interface and the nozzle create a positive pressure area between the entrainment port and the distal end of the nasal interface, and wherein a combination of gas from the gas source and air entrained through the entrainment port increases airway pressure.
Curved gas flow path positioning generating the positive pressure region proximal to the curve
The method wherein the gas flow path comprises a first section that is a substantially lateral-to-midline section and a second section distal to the first section that is a substantially inferior-to-superior section, and a curve between the two sections, with the positive pressure area substantially generated proximal to the curve.
Curved manifold for comfort positioning
The method wherein the nasal interface comprises a manifold that is curved with a lateral-posterior-inferior curve on each side of a midline to position the manifold where most comfortable to the patient.
Therapeutic delivery to reduce obstructive sleep apnea via jet nozzle and entrainment port with ambient open-airway breathing
A method delivering a therapeutic level of gas to a patient wherein the amount of gas increases pressure in the oropharyngeal airway to a pressure level able to reduce obstructive sleep apnea airway obstructions, including attaching a nasal interface to the patient that does not impede the patient from breathing ambient air directly through the interface; placing a jet nozzle in the nasal interface at a proximal end lateral to the nose; placing an entrainment port in the nasal interface between the jet nozzle and a distal end; attaching a ventilator to a gas delivery circuit and delivering gas from the ventilator to the jet nozzle; delivering gas from the nozzle into the nasal interface with a velocity that creates a negative pressure inside the interface at the location of the entrainment port at a distance from the interface distal end; configuring the interface to create a positive pressure between the negative pressure area and the interface distal end; and requiring that substantially all exhaled gas flows through the entrainment port and virtually none flows through the gas delivery circuit, wherein the therapeutic level of gas requires gas from the ventilator and ambient air entrained through the aperture by the velocity in the nasal interface created by the ventilation gas delivery.
Across the independent claims, the core claim coverage is the use of a non-impeding nasal interface that enables ambient breathing while a nozzle or jet nozzle delivers gas to create a negative pressure area at an entrainment port and a positive pressure area nearer the distal end, increasing airway or oropharyngeal pressure by combining ventilator gas with entrained ambient air. Additional refinements specify curved flow-path geometry with proximal positive pressure generation, a curved manifold for comfort positioning, and a therapeutic routing configuration in which substantially all exhaled gas passes through the entrainment port while virtually none passes through the gas delivery circuit.
Stated Advantages
Increases airway pressure by combining gas from the gas source with air entrained through the entrainment port.
Increases pressure in the oropharyngeal airway to a pressure level able to reduce obstructive sleep apnea airway obstructions.
Allows the patient to breathe ambient air directly through the nasal interface while delivering therapeutic gas.
Routes substantially all exhaled gas through the entrainment port and virtually none of exhaled gas through the gas delivery circuit.
Documented Applications
Reducing obstructive sleep apnea airway obstructions by increasing pressure in the oropharyngeal airway to a level able to reduce airway obstruction.
Therapeutic delivery for airway pressure support as described for increasing airway or lung pressure using non-invasive open-airway nasal ventilation.
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