WO2011029073A1 - Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature - Google Patents

Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature Download PDF

Info

Publication number
WO2011029073A1
WO2011029073A1 PCT/US2010/047920 US2010047920W WO2011029073A1 WO 2011029073 A1 WO2011029073 A1 WO 2011029073A1 US 2010047920 W US2010047920 W US 2010047920W WO 2011029073 A1 WO2011029073 A1 WO 2011029073A1
Authority
WO
WIPO (PCT)
Prior art keywords
nozzle
gas delivery
nose
gas
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2010/047920
Other languages
English (en)
French (fr)
Inventor
Joseph Cipollone
Joey Aguirre
Todd Allum
Darius Eghbal
Anthony D. Wondka
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Breathe Technologies Inc
Original Assignee
Breathe Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US12/753,856 external-priority patent/US9227034B2/en
Application filed by Breathe Technologies Inc filed Critical Breathe Technologies Inc
Priority to JP2012528111A priority Critical patent/JP5758898B2/ja
Priority to CA2773048A priority patent/CA2773048C/en
Priority to EP10814608.5A priority patent/EP2473220B1/en
Priority to CN201080049144.6A priority patent/CN102625720B/zh
Publication of WO2011029073A1 publication Critical patent/WO2011029073A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes with alarm devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A61M16/0672—Nasal cannula assemblies for oxygen therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A61M16/0672—Nasal cannula assemblies for oxygen therapy
    • A61M16/0677—Gas-saving devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0833—T- or Y-type connectors, e.g. Y-piece
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/085—Gas sampling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/0858—Pressure sampling ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
    • A61M16/122—Preparation of respiratory gases or vapours by mixing different gases with dilution
    • A61M16/125—Diluting primary gas with ambient air
    • A61M16/127—Diluting primary gas with ambient air by Venturi effect, i.e. entrainment mixers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A61M16/0063—Compressors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1045—Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • A61M16/161—Devices to humidify the respiration air with means for measuring the humidity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0024—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with an on-off output signal, e.g. from a switch
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1005—Preparation of respiratory gases or vapours with O2 features or with parameter measurement
    • A61M2016/102—Measuring a parameter of the content of the delivered gas
    • A61M2016/1025—Measuring a parameter of the content of the delivered gas the O2 concentration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/03—Gases in liquid phase, e.g. cryogenic liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3561—Range local, e.g. within room or hospital
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/42—Reducing noise
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/42—Rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/63—Motion, e.g. physical activity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/65—Impedance, e.g. conductivity, capacity

Definitions

  • the present invention relates to the field of ventilation therapy for persons suffering from respiratory and breathing disorders, such as respiratory insufficiency and sleep apnea. More specifically, the present invention relates to providing open airway ventilation with methods and devices that use non-sealing non-invasive nasal ventilation patient interfaces.
  • insufficiency insufficiency, airway or sleeping disorders, congestive heart failure, neuromuscular disease, and a range of situations that would be benefited, such as chronic, acute, emergency, mass casualty and pandemic situations.
  • Oxygen therapy is available with devices that do not encumber the patient.
  • oxygen therapy is used for far less severe forms of clinical syndromes compared to ventilation therapy.
  • some nasal mask oxygen therapy systems have been developed for the purpose of delivering mixtures of air and oxygen by entraining air into the mask, however these are not considered ventilation therapy or respiratory support, because they do not mechanically help in the work of breathing.
  • HFOT high flow oxygen therapy
  • LTOT standard long term oxygen therapy
  • the oxygen must be humidified to prevent drying out the patient's airway.
  • HFOT can slightly reduce the patient's absolute pleural pressure during spontaneous breathing, thus have a slight effect on work of breathing. These systems are inefficient in that they consume a significant quantity of oxygen, rendering them non- mobile systems and encumbering the patient.
  • Respiratory support and ventilation therapies exist that provide mechanical ventilation (MV) to the patient, and mechanically contribute to the work of breathing.
  • MV therapies connect to the patient by intubating the patient with a cuffed or uncuffed tracheal tube, or a sealing face or nasal mask or sealing nasal cannula.
  • NMV Noninvasive ventilation
  • the patient cannot use their upper airway because the interface makes an external seal against the nose and/or mouth, and in addition the system is not mobile, the combination of which does not enable activities of daily living.
  • the gold standard ventilation therapy is continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), which is a variant to NIV in that the patient partially exhales through exhaust ports in the mask and back into large gas delivery tubing, rather than through an exhalation circuit as in MV.
  • CPAP continuous positive airway pressure
  • BiPAP bilevel positive airway pressure
  • existing therapies and prior art have the following disadvantages: they do not offer respiratory support or airway support in a manner that unencumbers the patient and (1) is non-invasive, and un-obtrusive such that it allows for mobility and activities of daily living, (2) allows the sensation of breathing from the ambient surroundings normally, and (3) is provided in an easily portable system or a system that can be easily borne or worn by the patient.
  • Embodiments of the present invention may include a system for supplying ventilatory support, the system including a gas delivery source; a gas delivery circuit; a nasal interface configured to communicate with a patient's nose while allowing the patient to breathe ambient air directly without flowing through the nasal interface; a nozzle associated with the nasal interface at a distance from a nose, wherein the nozzle is connectable to the gas delivery circuit and the gas delivery source; and wherein the nozzle is capable of delivering gas into the nasal passage by creating negative pressure area near the nozzle and a positive pressure area near the entrance to the nose, wherein a combination of gas from the gas delivery source and air entrained from the gas exiting the nozzle provide ventilatory support.
  • NIOV non-invasive open- airway ventilation
  • Embodiments of the present invention may include a method for providing ventilatory support, the method including: providing a nasal interface that allows the patient to breathe ambient air through the nasal interface; providing a nozzle in free space associated with a proximal end of the nasal interface at a distance from a nose; adapting the nozzle to be in fluid communication with a gas delivery circuit and a gas delivery source, wherein the nozzle is capable of delivering gas into the nasal interface to create a negative pressure area near the nozzle and a positive pressure area near the entrance to the nose, and wherein a combination of gas from the gas delivery source and air entrained by the nozzle provides ventilatory support.
  • Certain embodiments of the systems and methods may also include that the positive pressure area may be created at a point outside the nose and distal to that point.
  • the positive pressure area may be created at an edge of a nostril rim and distal to the edge.
  • the positive pressure area may be created at a point in a nostril airway and distal to that point.
  • the nasal interface may include a manifold, and wherein the manifold comprises the nozzle.
  • the manifold may be configured to position the nozzle at a distance away from a nostril entrance, and may be configured to position the nozzle at an angle relative a centerline of a nostril airway.
  • Embodiments of the present invention may include one or more sensors, wherein the one or more sensors comprise a sensing channel that extends away from the nozzle toward the nose terminating in the positive pressure area, and/or wherein the one or more sensors comprise a sensing channel that extends toward distally away from the nozzle.
  • the sensing channel may extend into a nose.
  • the sensing channel may extend to within approximately +/- 5 mm from a nostril entrance.
  • Embodiments of the present invention may include two or more nozzles per nostril.
  • the nozzle may be an oval-shaped gas delivery nozzle orifice.
  • the nozzle may include an array of multiple gas delivery nozzles arranged in a circular or oval pattern.
  • Embodiments of the present invention may include a jet pump throat including a flow path.
  • the jet pump throat may be associated with a manifold, and the nozzle may be associated with a jet pump throat flow path through the jet pump throat.
  • the manifold may include an entrainment port in communication with the jet pump throat flow path.
  • the nozzle may angle inward.
  • the nozzle may angle inward at an angle of
  • the nozzle may create an oval shaped gas delivery flow profile within a nostril airway.
  • the nozzle may be rotatably adjustable.
  • the nozzle may include at least one left nozzle and at least one right nozzle, wherein the spacing between the at least one left nozzle and the at least one right nozzle is adjustable.
  • the at least one left nozzle and the at least one right nozzle may be rotate-ably adjustable. Spacing between a nostril entrance and nozzle may be adjustable.
  • the nasal interface may be available in different sizes, differing in nozzle spacing, nozzle rotational orientation and nozzle distance to nostril entrance.
  • the negative pressure area may extend from the nozzle to a location proximal to an entrance to a nose. A negative pressure may be less than ambient.
  • the negative pressure may be approximately -5 to -28 cmH20.
  • the positive pressure area may extend from a location distal to the nozzle to an entrance to a nose.
  • the positive pressure may be greater than ambient.
  • the positive pressure may be approximately 0.01 - 0.50 psi.
  • the combination of gas from the gas delivery source and the air entrained through entrained from the gas exiting the nozzle may be laminar flow within a nose.
  • the nozzle may be positioned approximately 0 - 1.5 inches outside the entrance to the nose. Delivery of gas through the nozzle may be synchronized with a breathing pattern of a patient.
  • the gas from the gas delivery source may be controlled by a wear-able ventilator. Ventilatory support may include reducing the work of breathing to treat respiratory insufficiency.
  • Ventilatory support may include elevating airway pressure to treat sleep apnea.
  • the nasal interface may include a connector for coupling the system to a bridge of the nose and aligning the at least one gas delivery jet nozzle with the entrance of the nose.
  • the connector may include a ledge to position the nasal interface relative to an edge of a nostril rim. The connector may adjust the angle of the nozzle to be in alignment with a centerline of a nostril airway.
  • Embodiments of the present invention may include a system for supplying ventilatory support, the system including: a gas delivery source; a gas delivery circuit; a nasal interface configured to communicate with a patient's nose while allowing the patient to breathe ambient air directly without flowing through the nasal interface; a nozzle associated with the nasal interface at a distance from a nose, wherein the nozzle is connectable to the gas delivery circuit and the gas delivery source; a jet pump throat comprising a flow path through the jet pump throat, wherein the jet pump throat is associated with a manifold, and the nozzle is associated with a jet pump throat flow path through the jet pump throat; and an entrainment port in communication with the jet pump throat flow path, wherein the nozzle is capable of delivering gas into the nasal passage by creating negative pressure area near the nozzle within the jet pump throat flow path and a positive pressure area within the jet pump throat flow path distal to the nozzle, wherein a combination of gas from the gas delivery source and air entrained through the entrainment port provide ventilat
  • Figure 1 shows a prior art conventional oxygen delivery cannula for administering oxygen therapy.
  • Figure 2 shows a prior art conventional non-invasive ventilation using a nose mask and using a CPAP or BiPAP ventilation mode.
  • Figure 3 shows an unencumbered patient using an embodiment of the invention to receive work of breathing support while ambulating.
  • Figure 4 is a schematic showing an exemplary system of the invention.
  • Figure 5 shows an exemplary embodiment where an open non-sealing nasal ventilation mask is configured to be placed under the nose of the user, and which may extend bilaterally from the midline of the face to the sides of the nose.
  • Figure 6 is a perspective view of the nasal mask assembly of Figure 5.
  • Figure 7 shows a front view schematic illustration of an embodiment of the nasal mask.
  • Figure 8 shows an anterior-top-side view of the nasal mask of Figure 5.
  • Figure 9 shows a hidden line view of the nasal mask of Figure 8, showing the gas flow path and breathing pressure sensing path.
  • Figure 10 shows a top view of the nasal mask of Figure 5.
  • Figure 11 shows a hidden line view of the nasal mask of Figure 10, showing the gas flow path and breathing pressure sensing path.
  • Figure 12 shows a rear-top view of the nasal mask of Figure 5.
  • Figure 13 shows a hidden line view of the nasal mask of Figure 12, showing the gas flow path and breathing pressure sensing path.
  • Figure 14 shows a pattern created by flow emission from gas delivery nozzles.
  • Figure 15 shows a pattern created by flow emission from gas delivery nozzles.
  • Figure 16 shows an embodiment of the nasal mask shown in Figure 5 with oval gas delivery nozzles.
  • Figure 17 shows an embodiment of the nasal mask shown in Figure 5 with multiple gas delivery nozzles arranged in an anatomically functional pattern.
  • Figure 18 shows a hidden line view of the mask view of an embodiment of the nasal mask, showing the gas flow path and breathing pressure sensing path, in which the gas delivery nozzles are angled inward toward the midline.
  • Figure 19 shows an embodiment of the mask shown in Figure 5 with a jet pump throat with a Venturi inlet at the bottom of the mask manifold.
  • Figure 20 shows a mask worn by a user with a jet pump throat with a Venturi inlet at the top of the manifold near the base of the throat.
  • Figure 21 shows an alternative embodiment of the nasal mask where the gas delivery nozzles are positioned under the nose by a nose piece with extension arm.
  • Figure 22 shows the pressure sensing and gas delivery flow patterns of the nasal mask of Figure 21 in the nostril airway.
  • Figure 23 shows the mask assembly of the nasal mask shown in Figure 21.
  • Figure 24 shows an alternate embodiment of the nasal mask shown in Figure 21 in which the gas delivery nozzles are positioned under the nose with an extended nose piece.
  • Figure 25 shows an embodiment of the nasal mask shown in Figure 21 with a minimized nose piece and streamlined vertical and horizontal arms.
  • Figure 26 shows an embodiment of the nasal mask shown in Figure 21 in which the gas delivery nozzles are positioned under the nose by a head gear and bracket.
  • Figure 27 graphically shows how the patient's work of breathing may be beneficially affected by the invention when the invention is used for lung disease or neuromuscular disease applications.
  • Figure 28 graphically shows lung volume on the x-axis and lung pressure on the y-axis to illustrate how the lung volumes achieved with NIOV on a lung simulator bench model in comparison to conventional ventilation.
  • Figure 29 graphically shows the lung volumes achieved with NIOV in comparison to oxygen therapy, using the lung simulator bench model.
  • Figure 30A graphically shows a square waveform gas delivery pressure, according to one embodiment.
  • Figure 30B graphically shows the volume delivery of Figure 30A.
  • Figure 30C graphically shows resulting lung pressure of Figure 30A.
  • Figure 30D graphically shows a sinusoidal waveform gas delivery pressure, according to one embodiment.
  • Figure 30E graphically shows the volume delivery of Figure 30D.
  • Figure 30F graphically shows resulting lung pressure of Figure 30D.
  • Figure 30G graphically shows a square waveform gas delivery pressure for a portion of the inspiratory phase, according to one embodiment.
  • Figure 30H graphically shows the volume delivery of Figure 30G.
  • Figure 301 graphically shows resulting lung pressure of Figure 30G.
  • Figure 30J graphically shows a multi-level waveform gas delivery pressure, according to one embodiment.
  • Figure 30K graphically shows the volume delivery of Figure 30J.
  • Figure 30L graphically shows resulting lung pressure of Figure 30J.
  • Figure 31 A graphically shows an ascending waveform gas delivery pressure, according to one embodiment.
  • Figure 3 IB graphically shows the volume delivery of Figure 31 A.
  • Figure 31C graphically shows resulting lung pressure of Figure 31 A.
  • Figure 3 ID graphically shows a descending waveform gas delivery pressure, according to one embodiment.
  • Figure 3 IE graphically shows the volume delivery of Figure 3 ID.
  • Figure 3 IF graphically shows resulting lung pressure of Figure 3 ID.
  • Figure 31G graphically shows a two-stage amplitude waveform gas delivery pressure for a portion of the inspiratory phase, according to one embodiment.
  • Figure 31 H graphically shows the volume delivery of Figure 31 G.
  • Figure 311 graphically shows resulting lung pressure of Figure 31G.
  • Figure 31J graphically shows an oscillatory waveform gas delivery pressure, according to one embodiment.
  • Figure 3 IK graphically shows the volume delivery of Figure 31 J.
  • Figure 31L graphically shows resulting lung pressure of Figure 31 J.
  • Figure 32 graphically shows the timing and amplitude of a breath frequency modulated gas flow amplitude delivery, according to one embodiment.
  • Figure 1 shows a prior art conventional oxygen delivery cannula 101 for administering oxygen therapy. Extensions 105 on the cannula 101 are configured to enter nares 103. A proximal end (not shown) of the cannula 101 is connected to an oxygen delivery device that delivers continuous flow oxygen at 1-6 LPM to the user's nose, or delivers a bolus of oxygen upon detection of an inspiratory effort.
  • the system of Figure 1 does not mechanically support the work of breathing of the patient, and is not believed to be effective in preventing moderate to severe forms of OS A.
  • the cannula of Figure 1 is also used with another oxygen delivery therapy, high flow oxygen therapy (HFOT), in which more than 15 LPM of humidified oxygen is delivered at a continuous flow rate to the user's nose. Due to the high flow required for HFOT, the system is non-portable and the oxygen must be humidified.
  • HFOT high flow oxygen therapy
  • FIG 2 shows a prior art respiratory support therapy for non-invasive ventilation (NIV), using a nose mask 201 in a bilevel positive airway pressure (BiPAP) ventilation mode.
  • NIV is used to breathe for the patient, or can be used to help the breathing of a patient, in which case the patient's spontaneous breathing effort triggers the ventilator to deliver the pressure or volume-based mechanical ventilation (MV). All of the volume delivered to and from the lungs is delivered and removed from a ventilation circuit 203 and the nose mask 201.
  • a similar system to Figure 2 can be used for OSA where a mask is sealed to the face so ventilation gas is provided by the ventilator and a portion of exhaled gas is exhaled through exhaust vents 205.
  • NIV, continuous positive airway pressure (CPAP) and BiPAP are believed to be clinically effective modes and therapies for spontaneously breathing patients. These modes and therapies, however, do not facilitate activities of daily living (ADL's).
  • the ventilator cannot be borne by the patient, the patient cannot breathe room air naturally and freely because of the sealing mask, and the patient's upper airway cannot function normally and naturally because it is sealed off with the external mask seal, and in addition the gas delivery tubing is too bulky to realistically support mobility and ADL's .
  • Respiratory support or airway support is provided in a manner and way that the patient is unencumbered.
  • the non-invasive, non-sealing and unobtrusive systems and methods may allow for mobility and activities of daily life.
  • the systems and methods allow for the sensation of breathing from ambient surroundings normally.
  • the systems and methods provide an easily portable system that can be readily borne or worn by the patient, and gas delivery tubing that does not encumber the patient.
  • Systems and methods may include a gas delivery source, a gas delivery circuit, and a nasal interface that allow 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 of the nasal interface. Gas from the gas delivery source and air entrained through the entrainment port may increase airway pressure.
  • Figure 3 shows a patient 301 using an embodiment of the invention to provide mechanical ventilatory support, or work of breathing support, while being mobile.
  • Conventional ventilators would require the patient to be stationary while receiving ventilatory support, or to use a wheel chair to carry the bulky and heavy equipment that is required for conventional ventilators.
  • Conventional ventilators also require an encumbering sealing mask and large bore gas delivery tubing.
  • the patient may also wear a ventilator module 307, which may be ultra-small that enables mobility when the invention is used for respiratory insufficiency.
  • the ventilator may be coupled by tubing or other means 309 to an air and or oxygen supply 311.
  • the ventilator module 307 may include a display 313 and/or input devices.
  • the present invention may include a non-sealing nasal mask patient interface, connected to the ventilator with small bore gas delivery tubing.
  • the nasal mask may be uniquely non-sealing, so that the patient can inhale and exhale ambient air directly through the mask while receiving ventilatory support, in which there is negligible dead space volume in the mask.
  • the mask may include a unique Venturi system that makes it possible for the ventilator to deliver relatively small amounts of gas to achieve relatively high levels of ventilatory support or airway pressure.
  • the Venturi mask is described in more detail in Figures 6 - 31.
  • Various embodiments of the nasal interface 303 are described in detail in the following disclosure.
  • the nasal interface 303 may be minimally obtrusive compared to standard masks, so that the patient can feel and act normally while receiving the therapy. For example, the patient can talk, swallow, eat or drink, and feel like they are breathing normally, with the nasal interface and therapy.
  • the gas delivery tubing required may be very small compared to standard ventilator tubing, which more readily allows the patient to move around with the system, and to conceal the equipment and tubing needed for the therapy.
  • the efficiency of the Venturi system in achieving therapeutic levels of lung or airway pressure while using low levels of gas volume, allows the gas supply to be relatively small, further enabling mobility of the patient, and or miniaturization of the ventilation equipment.
  • a nasal interface may be configured to communicate with a patient's nose while allowing the patient to breathe ambient air directly without flowing through the nasal interface.
  • Figure 3 shows the patient using the invention for mobility
  • the invention can also be applied to sleep disordered breathing.
  • an advantage of the invention is that the mask and tubing is smaller than standard sleep apnea therapy masks and tubing. Additionally, the patient can have the sensation of breathing ambient air more directly making the therapy tolerable to the patient, rather than breathing through a machine, which is the sensation when using standard sleep apnea ventilation devices.
  • Figure 4 is a block diagram describing an exemplary system of the invention.
  • the exemplary system of Figure 4 may be a wearable ventilator with portable gas source as shown in Figure 3, or may be a different ventilator and/or gas source. Ventilator and patient interface features associated with the system are shown schematically.
  • Figure 4 depicts a non-invasive open nasal interface 400.
  • the non-invasive open nasal interface will be described in various embodiments described herein, for example, in Figs. 5 - 8B (curved nasal mask), Figs. 9 - 15 (flexible joint), and Figs. 16 - 25 and 29 - 31
  • a ventilator module 401 may include or is in communication with several other functional accessories.
  • the ventilator and the patient's internal anatomy from Figure 3 are shown in schematic format in Figure 4.
  • a nasal airway pressure sensor 429 is typically included.
  • a transmitter 403 may be included to transmit information regarding the patient, the patient's therapy, and the ventilator performance to a remote location for review, analysis, remote intervention, two-way communication, and archiving. For example, the patient's compliance with the therapy or utilization of the therapy can be monitored and assessed. Important information can be trended, for example the patient's breath rate, I:E ratio, oxygen usage, activity level, or depth of breathing.
  • information can be sent to a ventilator 433, such as for example, sending programming instructions for setting titration options for the ventilator output to meet the needs of the patient, or sending instructions to the patient.
  • the patient can also send information or questions to a remote clinician through the ventilator and transmitter 403.
  • An oxygen source 407 and/or a compressed air source 409 can be included, typically external to the ventilator module 401. In certain embodiments, however, the oxygen source 407 and/or the compressed air source 409 can be internal to the ventilator module 401 if the therapy is being used for stationary use, for example, in the home.
  • a blender 411 can be included to control the fractional delivered 02 in a gas delivery circuit 413.
  • a pulse oximeter 415 can be used to titrate settings of the ventilator module 401 to meet the physiological needs of the patient, for example setting the correct oxygen blender setting or ventilator volume output.
  • the ventilator module 401 can include internal or external air and oxygen generating systems 417, such as a compressor, pump or blower to create pressurized air, an oxygen generator and/or pump to create pressurized oxygen gas, and/or a compressed gas accumulator.
  • the oxygen source can also be liquid oxygen, or a liquid oxygen generating system.
  • An internal or external humidifier 405 can be included for extended uses of the therapy, or if using in dry climates.
  • a pedometer 419 and/or actigraphy sensor 421 can be included internal to or external to a ventilator module 401.
  • Optional sensors may include a C0 2 sensor 425, and/or an external breathing sensor unit 437.
  • a C0 2 sensing line 439 and/or an airway pressure sensing line 441 may be present.
  • One or more other external sensors may be included.
  • other external sensors may include an external respiration sensor or respiration effort sensor 427, such as a respiratory muscle effort sensor, a chest impedance sensor 435, or other types of sensors, such as a tracheal or other microphone or vibration sensor 443 or acoustical or ultrasonic sensor.
  • the one or more external sensors may be used either as a redundant sensor to a nasal airflow or nasal pressure sensor 429, or to complement the information obtained from the nasal airflow or nasal pressure sensor 429, or in place of the nasal airflow or nasal pressure sensor 429.
  • An oral airflow breathing sensor may also be used, for example nasal airflow or nasal pressure sensor 429 may alternatively be an oral airflow sensor.
  • a drug delivery module 431 can be incorporated internally or externally to a ventilator module 401. Because of the challenges with current aerosolized drug delivery inhalers, the drug delivery module 431 can be used to propel and deposit medication particles deep in the respiratory system without a carrier propellant. Because the patient's using the therapy often may also require prescription medication, this may be a convenient and efficient way to administer the medication.
  • the user may have two options: (1) wearing or toting the ventilator module 401 so that the user can be ambulatory or enjoy the activities of daily living, or (2) stationary use, in the event the patient plans on being stationary or does not have the ability to ambulate.
  • the delivery circuit can optionally be provided in a 25-100 foot length, such that the gas source and ventilator module 401 can be stationary in the patient's home, while the patient can move around their home while wearing the interface and receiving the therapy.
  • the gas source can be stationary, and connected to the ventilator module 401 with a 25-100 foot hose, so that the patient can wear or tote the ventilator and be mobile within the range of the hose.
  • the ventilator module 401 may include one or more processors 445 and one or more memories 447 to analyze information and output therapies.
  • Ventilation gas 449 may exit at a speed that entrains ambient air 451 , such that the combination of ventilation gas 449, entrained ambient air 451 and spontaneously inhaled air, if the patient is spontaneously breathing, is delivered 453 to the patient's airways, such as the nasal cavity 455, oropharyngeal airway 457, trachea 459, lung 461 and others, under power to create a clinically efficacious effect on the lung and airways.
  • Patient may exhale 463 through the nose or mouth.
  • Various airways are also included, such as nostril airway 473, nasal airway 475, oral airway 481, upper airway 477, and lower airway 479.
  • the patient breathes normally through their upper airway and through their nose, while receiving mechanical support through the interface.
  • the exhaled gas preferably does not enter the gas delivery circuit but rather exits the nose or mouth directly to ambient air, or through, across or around the nasal interface 400 to ambient air.
  • the patient can keep their mouth closed during use for example during inspiration, to help direct the mechanical support to the lower airways and past the oral cavity 465, base of the tongue 467, palate 469 and esophagus 471, or can use a mouth guard or chin band, if necessary.
  • the patient may exhale through their mouth when using the therapy.
  • Figures 5 - 26 describe embodiments of the non-sealing open-airway nasal mask with nozzles in free space.
  • Systems and methods are described for ventilating a patient in a manner that unencumbers the user, by using a nasal ventilation patient interface and system that allows the user to breathe ambient air around the interface.
  • a gas delivery nozzle may be associated with the nasal interface at a distance from a nose.
  • the nozzle is connectable to a gas delivery circuit and ventilator, and delivers gas front the nasal interface toward the nose.
  • the nasal interface and the nozzle create a negative pressure area near the nozzle, and a positive pressure area near the entrance to the nose.
  • a combination of gas from the ventilator and entrained air are delivered to the patient to support the work of breathing.
  • Figure 5 describes an embodiment of the invention, showing a ventilation nasal mask assembly 500 with a nasal mask 501 configured to be placed under a nose 503 of a user, without sealing or impeding ambient air from freely flowing in and out of the nose 503.
  • the nasal mask 501 may include a manifold 505.
  • the nasal mask 501 may also include one or more breathing pressure sensing ports 507 or sensors, which are positioned close to an entrance to the nares.
  • the nasal mask 501 may include one or more gas delivery nozzles 509 spaced a distance away from the entrance to the nose 503.
  • the one or more gas delivery nozzles 509 may direct ventilation gas into the nasal airway, and entrain ambient air into the nasal airway.
  • Gas delivery tubing 511 and pressure sensing tubing 515 from a ventilator, as shown in Figure 4, may be coupled to the manifold 505 at proximal ends of the manifold 505.
  • the gas delivery tubing 511 and pressure sensing tubing 515 may be routed bilaterally away from the manifold 505 and around ears 513 of the user.
  • Figure 6 shows an isometric view of the nasal mask assembly 500, including the nasal mask 501 at the distal end of the nasal mask assembly 500, gas delivery tubing 511 and pressure sensing tubing 515 attached to the manifold 505 at a distal end of the gas delivery tubing 511 and pressure sensing tubing 515, a Y connector 601 joining the gas delivery tubing 511 and pressure sensing tubing 515 at proximal ends of each arm of the gas delivery tubing 511 and pressure sensing tubing 515, and a combined gas delivery and pressure sensing tubing 603 extending from the Y connector 601 to a ventilator connector 605.
  • a rotatable joint 517 between the gas delivery tubing 511 and manifold 503 and/or a rotatable joint 519 between the pressure sensing tube 515 and manifold 503, may include detent settings. These detent setting joints 517, 519 can be used to adjust the angle of the manifold 503 to adjust the angle of the gas delivery nozzles 507 to be in alignment with the patient's nostril airway.
  • the gas delivery tubing 511 and pressure sensing tubing 515 can be connectable to the manifold 503 in different rotational orientations to likewise align the gas delivery nozzles 507 with the patient's nostril airway.
  • Figure 7 describes a front view cross-sectional schematic representation of a nasal mask 701, showing one exemplary side of the nasal mask 701, for example, the left side.
  • Figure 7 shows a nostril airway 703, a nostril wall 705, a nostril entrance 707, a gas delivery nozzle 713, a gas flow channel 711 through the gas delivery nozzle 713, a manifold 709 that integrates the gas delivery nozzle 713, a breathing pressure sensing cannula 715, and a distance 717 between the gas delivery nozzle 713 and the nostril entrance 707.
  • a rounded distal tip of the gas delivery nozzle 713 may be used to assist in reduction of sound generated by gas exiting the gas delivery nozzle 713.
  • Figure 7 shows a specific nozzle tip to illustrate that the nozzle tip might be flared or rounded for sound mitigation.
  • the flare is an option.
  • the gas delivery nozzle 713 may be integrated into a manifold 709, and the manifold 709 may be shaped, dimensioned and configured to position the gas delivery nozzle 713 at an ideal position under a nostril entrance 707.
  • a distance of the gas delivery nozzle 713 to the nostril entrance 707 may be chosen to optimize the function of the Venturi created by the gas delivery nozzle 713 and the nares.
  • Optimal function may be described as generating maximal pressure in the nostril airway 703 while the gas delivery is still comfortable and tolerable to the user.
  • laminar positive pressure flow should be developed before the airflow reaches deep into the nostril.
  • This positive pressure flow may be defined by the area inside and distal to the gas flow cone defined by the gas exiting the gas delivery nozzle 713. The area outside of this cone is negative pressure created by the Venturi, which entrains ambient air into the nose and nasal passage, thus generating the energy required for mechanical ventilatory support.
  • the distal side of that intersecting point is positive pressure.
  • this cone can be wider than the entrance to the nostril when it reaches the nostril. In this event, positive pressure occurs outside of the nostril and extends distally. Also alternatively, this cone can intersect with the nostril walls at a distance inside the nostril, thereby allowing a negative pressure zone to occur at the entrance to and slightly inside the nostril, but then transitioning to positive pressure distal to the intersecting point. Because the cross sectional geometry is non-uniform, for example, not a perfectly circular, there is variability with the gas flow cone intersecting points with the nostril wall, around the circumference of the cone and nostril. As will be described subsequently, specific embodiments of the nasal mask may address this nuance such that more uniform and predictable performance can be achieved.
  • the nostril entrance 707 may act as a jet pump inlet and the nasal passage may act as a jet pump throat.
  • optimal function would dictate placing the gas delivery nozzle 713 at the nostril entrance 707 or slightly inside the nares; however, it was determined through empirical testing than in the average adult user, the optimal position for the gas delivery nozzle 713 to achieve optimal Venturi function is to place the gas delivery nozzle 713 approximately 0.950 inches from the nostril entrance 707.
  • gas delivery nozzles 713 may be positioned ideally at a distance away from the user's nostril entrance 707, breathing pressure sensing cannula 715, breathing pressure sensing ports or other sensors may need to be placed near, at or inside the nostril entrance 707.
  • the distal end of the pressure sensing cannula 715 can be placed slightly inside the nose in the area where positive pressure has been created by the Venturi system.
  • a breathing pressure sensing port may be placed slightly inside the nostril entrance 707, and a ventilation gas pressure sensor may be placed outside the nostril entrance 707, or alternatively deeper inside the nostril airway 703.
  • the location of pressure sensing ports may be selected to optimize accuracy and fidelity.
  • a breathing pressure sensing port such as the breathing pressure sensing cannula 715
  • a breathing pressure sensing port may be arranged so that it is located near the medial aspect of the nostril airway 703, or at the posterior aspect of the nostril airway 703.
  • Multiple breathing pressure sensing locations may also be used.
  • a sensing port at a medial posterior aspect of the nostril airway 703 may be used to measure inhalation pressures accurately
  • a sensing port at the anterior aspect of the nostril airway 703 may be used to measure exhalation pressures accurately.
  • a nostril airway breathing pressure sensor In addition to a nostril airway breathing pressure sensor, other sensor types or locations may be used. For example, a microphone or ultrasonic sensor can be used to detect phases of breathing when placed on the user's neck to detect movements of air in the trachea. Other sensors and sensor locations can be used.
  • the ventilation pressure can be derived by other apparatus and methods.
  • a gas delivery pressure in the gas delivery circuit can be correlated to a delivered ventilation pressure that is delivered to the patient by the ventilation system by measuring key relevant patient parameters, such as airway resistance and respiratory track compliance, and correlating those parameters with delivered pressure based on a gas delivery pressure.
  • Figure 8 shows a top-side view of the nasal mask 800 of an alternative embodiment of Figure 5, showing gas delivery nozzles 809 and pressure sensing cannula 803.
  • the gas delivery nozzles 809 may include a pair of exit ports 801 for both the right and left gas delivery nozzles 809. As discussed later, the dual exit ports 801 may improve the function and user tolerability of the device.
  • Figure 9 shows a hidden line view of the nasal mask 800 and manifold 805 shown in Figure 8, including a pressure sensing lumen 901 running from a first proximal end 903 of the manifold 805 to and through each of the pressure sensing cannula 803, and a gas delivery lumen 905 running from a second proximal end 907 of the manifold 805 to and through each of the exit ports 801.
  • Figure 10 shows a top view of the nasal mask 800 shown in Figure 8
  • Figure 11 shows a hidden line view of the nasal mask 800 shown in Figure 10.
  • Figure 12 shows a front-top view of the nasal mask 800 shown in Figure 8
  • Figure 13 shows a hidden line view of the nasal mask 800 shown in Figure 12.
  • the mask's left and right gas delivery may each be performed by multiple nozzles.
  • a pair of left and a pair of right gas exit ports 801 may be incorporated in the manifold 805, such that the pattern created by the gas exiting the exit ports 801 is spread out in a pattern approximating the cross-sectional area of the nostril airway, and thus facilitating creating laminar positive pressure flow.
  • the pattern 1401 created by flow emission from the exit ports 801 is shown in Figures 14 and 15. This flow and pressure head profile spreads out and smoothes out the flow profile, which may optimize the flow characteristics, and facilitate creating laminar positive pressure flow with minimal disturbance and resistance. Other embodiments may also be used.
  • the included angle between the gas flow path axis created by the left and right nozzles or nozzle patterns may be non- parallel.
  • a nozzle gas flow path 1801 and exit axis can be angled inward, for example at an angle of approximately 0.5-20 degrees inward, and preferably approximately 2-6 degrees inward. This angle may align the ventilation gas flow entering the nostril airway with the nostril airway, which may optimize flow characteristics, and facilitate creating laminar positive pressure flow with minimal disturbance and resistance.
  • Figures 14 and 15 describe the gas flow path pattern entering the nose.
  • a dual left and dual right gas delivery nozzle pattern is used in this description.
  • the combined gas flow pattern created in the nostril airway by the dual nozzle arrangement may distribute the delivered flow and velocity profile evenly across the proper cross-section of the nostril airway path. This may improve positive pressure formation before the gas travels deep into the nasal airway, improve laminar flow, and reduce turbulence that could be irritating to the user. For example, if the flow profile is more concentrated, a high velocity flow can impinge on a nerve receptor on the inside of the nasal passage, which could be intolerable to the user.
  • the spacing, angle, rotational position, and or orientation of the nozzles can be adjustable, or the mask can be available in different sizes so that the flow pattern created by the nozzles matches the size and shape of the user's nasal anatomy. For example, when dual nozzles are used, the nozzle positions can be rotated to rotate the rotational position of the oval pattern created by the pair of nozzles, so that the oval pattern matches with the oval orientation of the user's nostril airway.
  • the mask can include a jet pump throat section 1901.
  • Figure 19 has an entrainment port 1905 opening on bottom of a manifold 1907.
  • Figure 20 shows same throat section 1901, but has the entrainment ports 1905 on top of the manifold at the base of the throat section 1901.
  • ambient air may be entrained through the bottom of the manifold 1907.
  • ambient air may be entrained past the top of the manifold 1907.
  • the jet pump throat section 1901 can be useful in creating consistent performance of the ventilation system from one person to another, by minimizing the effect of patient anatomy on performance.
  • the jet pump throat section 1901 can also be useful in dampening the sound that is generated by the high velocity gas exiting gas delivery nozzles 1903 and entraining ambient air.
  • the jet pump throat section 1901 can alternatively include entrainment ports 1905 at the base of the jet pump throat section 1901 as shown in Figure 20, or a manifold 1907 can include a through-hole 1909 that functions as an entrainment aperture as shown in Figure 19, which extends through the thickness of the manifold 1907 from the bottom of the manifold 1907 to the top of the manifold 1907 and which is in communication with the gas delivery nozzle 1903.
  • the throat section 1901 of the mask shown in Figure 19 can also be used to reduce the sound generated by the Venturi and as such this embodiment may be useful in a sleep apnea application, in which minimal sound is a critical performance requirement.
  • the entrainment port 1905 is shown at bottom of manifold 1907 in Figure 19, but can be on the side of the jet pump throat section 1901, for example, near the nozzle 1903.
  • Gas delivery lumens 1911 may be included from either proximal end of the manifold 1907.
  • the nozzle in Figure 19 can be any type of nozzle. In Figure 19, there may be a throat option that is part of the manifold and outside of the nose.
  • Figure 21 describes an alternative embodiment of a nasal mask 2101 in which gas delivery nozzles 2103 are positioned in the correct location under the nose by use of a horizontal extension arm 2105 attached to a vertical extension arm 2107 that extends down from a nose piece 2109 that is configured to be placed on and secured to the front of the nose.
  • the nose piece 2109 can be secured to the nose by a variety of means, such as by using gas delivery tube 2115 and pressure sensing tube 2111 connected to the nasal mask 2101 to secure the nose piece 2109 to the face.
  • the nose piece 2109 can also be secured to the nose by other means, such as by straps, adhesives, a friction fit, or combinations thereof.
  • the vertical extension arm 2107 can be adjustable to position the gas delivery nozzles 2103 at the appropriate distance from the user, and the horizontal extension arm 2105 can be rotate-ably adjustable to angle the gas delivery nozzles 2103 correctly to be in alignment with the nostril airway.
  • the spacing between the gas delivery nozzles 2103 can be adjustable, for example by a linear adjustment in the horizontal arm.
  • Breathing pressure sensing ports may extend upward from the nose piece 2109 to be positively located at, near or inside the entrance to the nose.
  • the nose piece 2109 may include a shelf 2113 at its bottom end which is used to position against the outside of the nostril rim.
  • the breathing pressure sensing tube 2111 may be attached to one side of the nose piece 2109, the user's right side in Figure 21, and the gas delivery tube 2115 may be attached to the opposite side.
  • the nasal mask 2101 may also include additional sensing functions such as a C02 gas sampling port (not shown) and conduit extending to a capnometer (not shown), which can be included by integrating a secondary channel into the gas delivery tubing or pressure sensing tubing, and integrating the requsite channel into the mask nose piece and or extension arms.
  • the nose piece 2109 may also prevent gas being delivered from the gas delivery nozzles 2103 from being directed toward the eyes when the nasal mask 2101 is not fitted properly to the user.
  • the nasal mask 2101 may also include additional sensing functions such as a C0 2 gas sampling port (not shown) and conduit extending to a capnometer (not shown).
  • the nose piece 2109 may also prevent gas being delivered from the gas delivery nozzles 2103 from being directed toward the eyes when the nasal mask 2101 is not fitted properly to the user.
  • This embodiment of the invention may use the angle of the medial aspect of the bridge of the nose to align the therapy to the patient.
  • the gas delivery nozzles 2103 were aimed parallel to the bridge of the nose to align the jets of ventilation gas with the nares.
  • the gas delivery nozzles 2103 of the nasal mask 2101 may be aimed parallel to the nose piece 2109, such that by placing the nose piece 2109 on the bridge of the nose, the gas delivery nozzles 2103 may be parallel to the bridge of the nose.
  • gas delivery nozzles 2103 preferably are kept within 10 degrees of being properly aligned with a nasal opening and an axis of the nares. As such, when a patient moves their nose to the left or right (e.g. by moving your jaw in an exaggerated manner), the nasal mask 2101 may follow the nose, ensuring that the gas delivery nozzles 2103 remain aligned with the centerline of the nose, and therefore the nostrils.
  • gas delivery patterns 2205 may include two intersecting circles to create an effective oval pattern, which are for example generated by dual nozzles, as explained previously for the purpose of developing a laminar cross section of flow and positive pressure in the nostril airway.
  • Figure 22 shows a bottom view of a nose 2201 and how the nasal mask 2101 of Figure 21 is aligned with the nose 2201.
  • a breathing pressure sensing location 2203 and gas delivery patterns 2205 are superimposed on the bottom view image of a nose 2201 and the nostril airway 2207 as depicted by the two large oval shapes.
  • Gas delivery pattern 2205 and nasal air pressure sensing locations 2203 are indicated by the large and small circles, respectively.
  • the patterns 2205 are generated in this example by two gas delivery nozzles for the left and right nostril, which applies to other mask embodiments of the invention in addition to the mask of Figure 22.
  • the nasal air pressure sensing ports may be protrusions to help achieve a positive location of the sensing ports in the breath path in the nares.
  • the gas delivery ports may be positioned such that the gas delivery path has a clear path to the nostril airway.
  • the previous figures describe that the sensing locations must be in proximity to the entrance of the nostril, either inside, coplanar to the entrance, or slightly outside but if outside no more than 5mm away from the entrance, whereas the gas delivery nozzle tips are located a distance from the entrance to the nostrils, for example 10-25mm away.
  • This configuration may allow the nasal mask 2201 to take advantage of the jet pump geometry, while not sacrificing sensing accuracy, so that the ventilator is in proper synchrony with the patient. Also, the gas flow profile may become more organized before entering the patient's nostril, rather than a turbulent jet entering the nostril, which would be quite uncomfortable and intolerant to the patient.
  • Figure 23 shows an isometric view of the patient circuit assembly 2301 of the nasal mask 2201 shown in Figure 21.
  • a Y connector 2303 joining a breathing pressure sensing tube 2111 and gas delivery tube 2115 is shown, and combined tubing 2305 and a ventilator connector 2307 at a proximal end of the patient circuit are shown.
  • Figures 24 and 25 describe aesthetically streamlined versions of the nasal mask shown in Figure 21.
  • the nose pieces 2401 , 2501 may be trimmed to optimize the comfort and to minimize the obtrusiveness to the user.
  • the gas delivery nozzles 2403 may be positioned under the nose by an extension 2405 of the nose piece 2401 itself versus the vertical extension arm of the mask in Figure 21.
  • the nose piece 2501 may be a strip on the top of the bridge of the nose and the gas delivery nozzles 2503 may be positioned by use of a streamlined vertical arm 2505 and a streamlined horizontal arm 2507.
  • Figure 26 shows a version of the mask shown in Figure 21 in which gas delivery nozzles 2601 are positioned under the nose at the correct location using head gear 2603 with an extension arm 2605.
  • the head gear 2603 and extension arm 2605 can be adjustable to position the gas delivery nozzles 2601 and breathing pressure sensing ports (not shown) in the correct location.
  • Diameters listed are effective diameters (average cross sectional dimension).
  • Figure 27 describes the mechanism of action of the invention, and how the patient's work of breathing may be beneficially affected by the invention, when the invention is used for lung disease or neuromuscular disease applications.
  • the patient's lung volume may be graphed as a function of lung pressure, the area inside the curve representing work, typically expressed in Joules per Liter (J/L), and for a normal healthy adult can be 0.3-0.6 J/L.
  • J/L Joules per Liter
  • 4-10 times more work can be required to breathe during rest, and even more during exertion, to overcome the diseased state of the tissue, for example to overcome static and dynamic hyperinflation as in the case of COPD, or to overcome high airways resistance as in the case of fibrosis or ARDS.
  • RV1 and VT1 are the residual volume and tidal volume without the therapy.
  • Line 3201 represents spontaneous breathing without non-invasive open nasal ventilation.
  • Line 3203 represents spontaneous breathing with non-invasive open nasal ventilation, with inspiratory augmentation and positive end-expiratory pressure (PEEP) therapy.
  • RV2 and VT2 are the residual volume and tidal volume with the therapy.
  • RV increases with the therapy because in this example, expiratory flow is provided as part of the therapy, which may increase residual volume.
  • VT is increased with the therapy and is increased more that the RV is increased, indicating that more volume is entering and leaving the lung as a result of the therapy.
  • the increase in tidal volume is considered clinically efficacious, however is technically challenging to achieve in an open ventilation, noninvasive and minimally obtrusive system.
  • the patient's inspiratory WOB with the invention ON may be about 25% less than the patient's inspiratory WOB with the invention OFF.
  • inspiratory lung pressure increases (is less negative) and tidal volume increases, and optionally exhaled pressure increases if the therapy is provided during exhalation.
  • residual volume increases in the example shown because the ventilator is providing gas in this example during the expiratory phase, the ventilation parameters can be titrated to not effect residual volume, and because of the ability of the patient to exercise their lung muscles when receiving the therapy, the patient's lung mechanics may remodel in the case of COPD, actually causing a reduction of residual volume to a more normal value.
  • the waveform with therapy assumes an early inspiratory trigger time for the ventilator inspiratory phase therapy output, and that the volume output is delivered within the patient's inspiratory time.
  • the ventilator inspiratory phase therapy can be delivered late in the person's inspiratory cycle, with delivery completing at the end of inspiration, and delivered with a square or ascending waveform profile.
  • the WOB curve with therapy will be tilted upward to the right of the curve, such that inspiration ends and transitions to exhalation at a point above the lung pressure zero axis.
  • Figure 28 graphically illustrates the lung volumes achieved with NIOV on a lung simulator bench model in comparison to conventional ventilation.
  • the simulated patient is spontaneously breathing at the same inspiratory effort which results in a tidal volume of 245 ml, and the clinical goal is to increase the patient's tidal volume from 245ml 3301 to 380ml 3303.
  • the patient's breath 3305 is un-assisted and thus the patient receives a tidal volume of 245ml.
  • the simulated patient with the same effort is assisted with a traditional closed system ventilator, such as with a sealed breathing mask or cuffed airway tube.
  • the ventilator output 3309 is set to a level to achieve the desired "assisted" tidal volume of 380ml.
  • the ventilator is set to 420ml to achieve this goal, as there is a discrepancy between the gas delivered to the lung by the ventilator versus the gas delivered by the ventilator but not reaching the lung and wasting to ambient 3307.
  • a small leak is introduced in the conventional ventilator system, such as would be done in the case of weaning the patient off of the ventilator.
  • the ventilator To achieve the desired "assisted" tidal volume of 380ml, the ventilator must now be set at 705ml.
  • the NIOV ventilator output only has to be set at 90ml to achieve desired "assisted" level of 380ml.
  • the ventilator only some of the 380ml tidal volume comes from the ventilator, and a substantial portion of the 380ml comes from entrainment and spontaneously inspired ambient air 3311, therefore making the NIOV system far more efficient, comfortable, and healthier, than the other systems.
  • Figure 29 graphically shows NIOV in comparison to oxygen therapy, using the lung simulator bench model.
  • the patient In the first waveform on the left, the patient is unassisted and breathes at an effort of -0.8cmH2O, generating 248ml of inspired tidal volume 3401.
  • the patient receives continuous flow 3403 and pulsed flow 3405 of oxygen respectively via nasal cannula, with no or negligible effect on lung pressure and tidal volume.
  • NIOV 3407 is used which shows a marked increase in lung pressure and tidal volume, thus indicating that NIOV helps in the work-of-breathing as described earlier, despite the fact that NIOV is an open airway system.
  • Figures 30A - 30L show exemplary ventilation gas delivery profiles of the invention and their respective effect on lung volume and lung pressure.
  • Figures 30A, 30D, 30G and 30J show exemplary pressure and/or flow waveforms delivered by the ventilator.
  • Figure 30A describes a square waveform 3501 delivered during the complete inspiratory cycle;
  • Figure 30D describes an ascending and descending waveform 3503;
  • Figure 30G describes a square waveform 3507 delivered for the first part of the patient's spontaneous inspiratory time;
  • Figure 30J shows a multilevel amplitude waveform 3509 with a first amplitude 3511 delivered during the inspiratory phase and a second amplitude 3513 during the expiratory phase, where the second amplitude 3513 for example is used to deliver positive end-expiratory pressure (PEEP), which in some clinical applications will be efficacious.
  • Other waveforms are also included in the invention, such as a descending trapezoidal or ascending trapezoidal square wave.
  • the pressure and flow rate output from the ventilator into the gas delivery tubing is typically in the 5-40 psi and 6-30 1pm range.
  • Figures 30B, 30E, 30H and 30K describe the lung volume being delivered by the therapy including a ventilator output 3515 and an entrained volume 3517.
  • Figures 30C, 30F, 301 and 30L show the lung pressure without therapy represented by the dashed line 3519, and the resultant lung pressures with the therapy represented by the solid line 3521, showing a positive inspiratory pressure in Figure 30C for the entire inspiratory phase, a positive inspiratory pressure for part of the inspiratory phase in Figures 30F and 301, with therapy extending into exhalation 3523, and an elevated negative inspiratory pressure in Figure 30L.
  • Figures 36A - 36L describe additional exemplary ventilation gas delivery profiles of the invention and their respective effect on lung volume and lung pressure.
  • Figure 31 A describes an ascending waveform 3601.
  • Figure 3 ID describes a descending waveform 3603.
  • Figure 31G describes a multi-level waveform 3605 with a lower amplitude in the first portion of the inspiratory phase, for example to deliver the necessary oxygen molecules to the lung early in the breath phase, and a higher amplitude in the second portion of the inspiratory phase, for example to deliver the mechanical support portion of the therapy to help the work of breathing.
  • Figure 31J describes an oscillatory waveform 3607, which may be use the gas supply more efficiently while producing nearly the same Venturi, entrainment and therapeutic effect.
  • Figures 3 IB, 3 IE, 31H and 3 IK describe the lung volume being delivered by the therapy including a ventilator output 3609 and an entrained volume 361 1.
  • Figures 31C, 3 IF, 311 and 31L show the lung pressure without therapy represented by the dashed line 3613, and the resultant lung pressures with the therapy represented by the solid line 3615.
  • the lung pressure resulting from the therapy may be governed by a combination of factors: the gas delivery circuit pressure, the jet pump design and configuration, the patient's lung compliance and airway resistance, the patient's breathing effort, the timing of the ventilator output relative to the patient's inspiratory phase, and the ventilator output waveform.
  • a gas delivery circuit pressure of 30psi delivering 100ml with a square waveform, and delivered for 500msec starting at the beginning of the patient's inspiratory phase may increase lung pressure by 5-15cmH20.
  • a gas delivery circuit pressure of 30psi delivering 250ml with a trapezoidal waveform, and delivered for 700msec during the majority of the patient's inspiratory phase may increase lung pressure by 10-25cmH2O.
  • the gas delivered by the ventilator can be oxygen, air, oxygen-air mixtures, or therapeutic gases such as helium.
  • the patient's lung pressure and lung volume is increased, which allows the patient to exert them self without being limited by fatigue and dyspnea.
  • the patient reduces their breathing effort in response to the pressure and volume support provided by the therapy, thus resulting in no change in total lung volume from the therapy, but resulting in a reduced work of breathing.
  • FIG 32 is a diagram of timing and gas flow delivery, according to one embodiment.
  • Amplitude of gas flow delivery rate 3701 modulates with respiratory rate to affect airway pressure 3703. The faster the respiratory rate, the higher the amplitude.
  • the volume delivery may be maintained at a constant rate, unless changed by the user, between the restful state and exertion state. However, the amount of power delivered by the system may be higher during the exertion state, because the faster flow rate entrains more gas, which produces more power and higher lung pressures during inspiratory phase. Further, the delivery time of the delivered flow can be adjusted by the user as a percentage of the breath period.
  • a 25% delivery time setting would equal a delivered flow pulse width of 0.75 seconds.
  • the delivered flow pulse width would change with the breath rate; however, it may continue to be 25% of the breath period (unless changed by the user).
  • the setting can be set for example in the range of 15% to 70% of the breath period.
  • the setting may be independent of the volume setting. For example, a setting of 25% versus 40% may still deliver the same set volume, and may merely deliver the set volume at different flow rates.
  • the algorithm for adjusting the delivered flow pulse time may, for example, look at the preceding 3 to 5 breaths to determine what the current breath period is, and may have a correction factor to rule out outlier breaths.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
PCT/US2010/047920 2009-09-03 2010-09-03 Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature Ceased WO2011029073A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2012528111A JP5758898B2 (ja) 2009-09-03 2010-09-03 自由空間のノズル・フィーチャを備える非密封式換気インターフェイスを含む、換気補助システムおよび換気装置
CA2773048A CA2773048C (en) 2009-09-03 2010-09-03 Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature
EP10814608.5A EP2473220B1 (en) 2009-09-03 2010-09-03 System for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature
CN201080049144.6A CN102625720B (zh) 2009-09-03 2010-09-03 用于包括具有自由空间喷嘴特征的非密封通气界面的无创通气的方法、系统和装置

Applications Claiming Priority (26)

Application Number Priority Date Filing Date Title
US23972809P 2009-09-03 2009-09-03
US61/239,728 2009-09-03
US25576009P 2009-10-28 2009-10-28
US61/255,760 2009-10-28
US29436310P 2010-01-12 2010-01-12
US61/294,363 2010-01-12
US30637010P 2010-02-19 2010-02-19
US61/306,370 2010-02-19
US12/753,856 US9227034B2 (en) 2009-04-02 2010-04-02 Methods, systems and devices for non-invasive open ventilation for treating airway obstructions
US12/753,854 US10046133B2 (en) 2009-04-02 2010-04-02 Methods, systems and devices for non-invasive open ventilation for providing ventilation support
USPCT/US2010/029874 2010-04-02
US12/753,854 2010-04-02
PCT/US2010/029873 WO2010115168A1 (en) 2009-04-02 2010-04-02 Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within an outer tube
US12/753,853 US10695519B2 (en) 2009-04-02 2010-04-02 Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within nasal pillows
US12/753,853 2010-04-02
US12/753,851 US9180270B2 (en) 2009-04-02 2010-04-02 Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within an outer tube
PCT/US2010/029874 WO2010115169A1 (en) 2009-04-02 2010-04-02 Methods, systems and devices for non-invasive open ventilation for providing ventilation support
USPCT/US2010/029871 2010-04-02
US12/753,846 2010-04-02
PCT/US2010/029875 WO2010115170A2 (en) 2009-04-02 2010-04-02 Methods, systems and devices for non-invasive open ventilation for treating airway obstructions
US12/753,846 US9675774B2 (en) 2009-04-02 2010-04-02 Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles in free space
US12/753,856 2010-04-02
USPCT/US2010/029873 2010-04-02
USPCT/US2010/029875 2010-04-02
US12/753,851 2010-04-02
PCT/US2010/029871 WO2010115166A1 (en) 2009-04-02 2010-04-02 Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles in free space

Publications (1)

Publication Number Publication Date
WO2011029073A1 true WO2011029073A1 (en) 2011-03-10

Family

ID=70049795

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/047920 Ceased WO2011029073A1 (en) 2009-09-03 2010-09-03 Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature

Country Status (4)

Country Link
EP (1) EP2473220B1 (enExample)
JP (2) JP6153725B2 (enExample)
CA (1) CA2773048C (enExample)
WO (1) WO2011029073A1 (enExample)

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8136527B2 (en) 2003-08-18 2012-03-20 Breathe Technologies, Inc. Method and device for non-invasive ventilation with nasal interface
US8381729B2 (en) 2003-06-18 2013-02-26 Breathe Technologies, Inc. Methods and devices for minimally invasive respiratory support
US8418694B2 (en) 2003-08-11 2013-04-16 Breathe Technologies, Inc. Systems, methods and apparatus for respiratory support of a patient
US8567399B2 (en) 2007-09-26 2013-10-29 Breathe Technologies, Inc. Methods and devices for providing inspiratory and expiratory flow relief during ventilation therapy
US8677999B2 (en) 2008-08-22 2014-03-25 Breathe Technologies, Inc. Methods and devices for providing mechanical ventilation with an open airway interface
US8770193B2 (en) 2008-04-18 2014-07-08 Breathe Technologies, Inc. Methods and devices for sensing respiration and controlling ventilator functions
US8776793B2 (en) 2008-04-18 2014-07-15 Breathe Technologies, Inc. Methods and devices for sensing respiration and controlling ventilator functions
US8925545B2 (en) 2004-02-04 2015-01-06 Breathe Technologies, Inc. Methods and devices for treating sleep apnea
US8939152B2 (en) 2010-09-30 2015-01-27 Breathe Technologies, Inc. Methods, systems and devices for humidifying a respiratory tract
US8955518B2 (en) 2003-06-18 2015-02-17 Breathe Technologies, Inc. Methods, systems and devices for improving ventilation in a lung area
US8985099B2 (en) 2006-05-18 2015-03-24 Breathe Technologies, Inc. Tracheostoma spacer, tracheotomy method, and device for inserting a tracheostoma spacer
US9132250B2 (en) 2009-09-03 2015-09-15 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
US9180270B2 (en) 2009-04-02 2015-11-10 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within an outer tube
WO2016203211A1 (en) * 2015-06-13 2016-12-22 Venner Medical Technologies Sa Medical gas flow safety system
WO2018071699A1 (en) * 2016-10-13 2018-04-19 Vyaire Medical Capital Llc Nasal cannula systems
US9962512B2 (en) 2009-04-02 2018-05-08 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature
US10058668B2 (en) 2007-05-18 2018-08-28 Breathe Technologies, Inc. Methods and devices for sensing respiration and providing ventilation therapy
US10099028B2 (en) 2010-08-16 2018-10-16 Breathe Technologies, Inc. Methods, systems and devices using LOX to provide ventilatory support
US10252020B2 (en) 2008-10-01 2019-04-09 Breathe Technologies, Inc. Ventilator with biofeedback monitoring and control for improving patient activity and health
US10384028B2 (en) 2012-09-12 2019-08-20 Silverbow Development, Llc Nasal interface apparatus and systems for use with a respiratory assist device
DE102018112903A1 (de) 2018-03-16 2019-09-19 Fritz Stephan Gmbh Medizintechnik Sauerstofftherapiegerät
US10792449B2 (en) 2017-10-03 2020-10-06 Breathe Technologies, Inc. Patient interface with integrated jet pump
US11154672B2 (en) 2009-09-03 2021-10-26 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
EP3914326A4 (en) * 2019-01-24 2022-10-19 Inogen, Inc. Nasal interface apparatus and systems for use with a respiratory assist device
US11904096B2 (en) 2012-09-12 2024-02-20 Inogen, Inc. Nasal interface apparatus and systems for use with a respiratory assist device
US12239788B2 (en) 2013-10-16 2025-03-04 Fisher & Paykel Healthcare Limited Patient interface

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012106373A2 (en) * 2011-01-31 2012-08-09 Breathe Technologies, Inc. Methods, systems and devices for ventilation using a nasal ventilation mask with a manifold and internal compliant tube and nasal sealing cushion assembly
NZ630742A (en) * 2014-05-01 2016-02-26 Resmed Ltd A patient interface
US11058841B2 (en) 2014-09-19 2021-07-13 Fisher & Paykel Healthcare Limited Patient interface
KR102528366B1 (ko) * 2021-01-12 2023-05-03 (주) 멕아이씨에스 호흡 동기화를 통한 고유량 호흡 치료 장치 및 이의 제어 방법

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003068301A1 (en) 2002-02-15 2003-08-21 Oridion Medical 1987 Ltd. Dual function nasal cannula
US20050011524A1 (en) * 2003-07-17 2005-01-20 Marguerite Thomlinson Nasal interface apparatus
US20050121033A1 (en) * 1998-02-25 2005-06-09 Ric Investments, Llc. Respiratory monitoring during gas delivery
US20070074724A1 (en) * 2005-09-30 2007-04-05 Steven Duquette Venturi geometry design for flow-generator patient circuit
US20070095347A1 (en) 2000-06-13 2007-05-03 Scott Laboratories, Inc. Apparatus and method for mask free delivery of an inspired gas mixture and gas sampling

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE462614B (sv) * 1988-12-06 1990-07-30 Conny Peder Gunnar Moa Anordning foer att genom ejektorverkan generera kontinuerligt positivt luftvaegstryck vid spontanandning
US6851425B2 (en) * 2001-05-25 2005-02-08 Respironics, Inc. Exhaust port assembly for a pressure support system
GB0204117D0 (en) * 2002-02-21 2002-04-10 E M E Electro Medical Equipmen Breathing device
NZ577553A (en) * 2003-02-21 2011-01-28 Resmed Ltd Nasal assembly
WO2005007056A2 (en) * 2003-07-22 2005-01-27 Zinder, Oren A respiratory aid system and method
WO2005011556A2 (en) * 2003-07-28 2005-02-10 Salter Labs Respiratory therapy system including a nasal cannula assembly
US7578294B2 (en) * 2005-12-02 2009-08-25 Allegiance Corporation Nasal continuous positive airway pressure device and system
JP2009519759A (ja) * 2005-12-14 2009-05-21 マージェネット メディカル，インコーポレイテッド 非密閉呼吸インタフェースを利用する高流速治療デバイス及び関連方法
US20070163600A1 (en) * 2006-01-11 2007-07-19 Leslie Hoffman User interface and head gear for a continuous positive airway pressure device
JP2007229207A (ja) * 2006-03-01 2007-09-13 Saitama Univ ネーザルｃｐａｐ素子
US8210182B2 (en) * 2007-12-28 2012-07-03 Carefusion 207, Inc. Continuous positive airway pressure device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050121033A1 (en) * 1998-02-25 2005-06-09 Ric Investments, Llc. Respiratory monitoring during gas delivery
US20070095347A1 (en) 2000-06-13 2007-05-03 Scott Laboratories, Inc. Apparatus and method for mask free delivery of an inspired gas mixture and gas sampling
WO2003068301A1 (en) 2002-02-15 2003-08-21 Oridion Medical 1987 Ltd. Dual function nasal cannula
US20050011524A1 (en) * 2003-07-17 2005-01-20 Marguerite Thomlinson Nasal interface apparatus
US20070074724A1 (en) * 2005-09-30 2007-04-05 Steven Duquette Venturi geometry design for flow-generator patient circuit

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2473220A4

Cited By (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8955518B2 (en) 2003-06-18 2015-02-17 Breathe Technologies, Inc. Methods, systems and devices for improving ventilation in a lung area
US8381729B2 (en) 2003-06-18 2013-02-26 Breathe Technologies, Inc. Methods and devices for minimally invasive respiratory support
US8418694B2 (en) 2003-08-11 2013-04-16 Breathe Technologies, Inc. Systems, methods and apparatus for respiratory support of a patient
US8573219B2 (en) 2003-08-18 2013-11-05 Breathe Technologies, Inc. Method and device for non-invasive ventilation with nasal interface
US8136527B2 (en) 2003-08-18 2012-03-20 Breathe Technologies, Inc. Method and device for non-invasive ventilation with nasal interface
US8925545B2 (en) 2004-02-04 2015-01-06 Breathe Technologies, Inc. Methods and devices for treating sleep apnea
US8985099B2 (en) 2006-05-18 2015-03-24 Breathe Technologies, Inc. Tracheostoma spacer, tracheotomy method, and device for inserting a tracheostoma spacer
US10058668B2 (en) 2007-05-18 2018-08-28 Breathe Technologies, Inc. Methods and devices for sensing respiration and providing ventilation therapy
US8567399B2 (en) 2007-09-26 2013-10-29 Breathe Technologies, Inc. Methods and devices for providing inspiratory and expiratory flow relief during ventilation therapy
US8770193B2 (en) 2008-04-18 2014-07-08 Breathe Technologies, Inc. Methods and devices for sensing respiration and controlling ventilator functions
US8776793B2 (en) 2008-04-18 2014-07-15 Breathe Technologies, Inc. Methods and devices for sensing respiration and controlling ventilator functions
US8677999B2 (en) 2008-08-22 2014-03-25 Breathe Technologies, Inc. Methods and devices for providing mechanical ventilation with an open airway interface
US10252020B2 (en) 2008-10-01 2019-04-09 Breathe Technologies, Inc. Ventilator with biofeedback monitoring and control for improving patient activity and health
US10046133B2 (en) 2009-04-02 2018-08-14 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation for providing ventilation support
US10232136B2 (en) 2009-04-02 2019-03-19 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation for treating airway obstructions
US10709864B2 (en) 2009-04-02 2020-07-14 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles with an outer tube
US12161807B2 (en) 2009-04-02 2024-12-10 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within nasal pillows
US9675774B2 (en) 2009-04-02 2017-06-13 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles in free space
US10695519B2 (en) 2009-04-02 2020-06-30 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within nasal pillows
US9962512B2 (en) 2009-04-02 2018-05-08 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature
US9180270B2 (en) 2009-04-02 2015-11-10 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within an outer tube
US11707591B2 (en) 2009-04-02 2023-07-25 Breathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles with an outer tube
US9227034B2 (en) 2009-04-02 2016-01-05 Beathe Technologies, Inc. Methods, systems and devices for non-invasive open ventilation for treating airway obstructions
US12048813B2 (en) 2009-09-03 2024-07-30 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
US10265486B2 (en) 2009-09-03 2019-04-23 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
US9132250B2 (en) 2009-09-03 2015-09-15 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
US11154672B2 (en) 2009-09-03 2021-10-26 Breathe Technologies, Inc. Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
US10099028B2 (en) 2010-08-16 2018-10-16 Breathe Technologies, Inc. Methods, systems and devices using LOX to provide ventilatory support
US8939152B2 (en) 2010-09-30 2015-01-27 Breathe Technologies, Inc. Methods, systems and devices for humidifying a respiratory tract
US9358358B2 (en) 2010-09-30 2016-06-07 Breathe Technologies, Inc. Methods, systems and devices for humidifying a respiratory tract
US10384028B2 (en) 2012-09-12 2019-08-20 Silverbow Development, Llc Nasal interface apparatus and systems for use with a respiratory assist device
US11376387B2 (en) 2012-09-12 2022-07-05 Inogen, Inc. Nasal interface apparatus and systems for use with a respiratory assist device
US11904096B2 (en) 2012-09-12 2024-02-20 Inogen, Inc. Nasal interface apparatus and systems for use with a respiratory assist device
US12239788B2 (en) 2013-10-16 2025-03-04 Fisher & Paykel Healthcare Limited Patient interface
WO2016203211A1 (en) * 2015-06-13 2016-12-22 Venner Medical Technologies Sa Medical gas flow safety system
US11638798B2 (en) 2016-10-13 2023-05-02 Vyaire Medical Capital, LLC Nasal cannula systems and methods
WO2018071699A1 (en) * 2016-10-13 2018-04-19 Vyaire Medical Capital Llc Nasal cannula systems
US10792449B2 (en) 2017-10-03 2020-10-06 Breathe Technologies, Inc. Patient interface with integrated jet pump
DE102018112903A1 (de) 2018-03-16 2019-09-19 Fritz Stephan Gmbh Medizintechnik Sauerstofftherapiegerät
EP3914326A4 (en) * 2019-01-24 2022-10-19 Inogen, Inc. Nasal interface apparatus and systems for use with a respiratory assist device

Also Published As

Publication number Publication date
EP2473220A1 (en) 2012-07-11
CA2773048A1 (en) 2011-03-10
JP6153725B2 (ja) 2017-06-28
JP2013503719A (ja) 2013-02-04
EP2473220A4 (en) 2014-10-01
JP5758898B2 (ja) 2015-08-05
JP2013503720A (ja) 2013-02-04
EP2473220B1 (en) 2018-11-07
CA2773048C (en) 2017-01-03

Similar Documents

Publication Publication Date Title
US12048813B2 (en) Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
US9962512B2 (en) Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature
CA2773048C (en) Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with a free space nozzle feature
US12364835B2 (en) Methods, systems and devices for non-invasive ventilation with gas delivery nozzles in free space
US10265486B2 (en) Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature
US9199053B1 (en) Methods, systems and devices for ventilation using a nasal ventilation mask with a manifold and internal compliant tube and nasal sealing cushion assembly
US20240342419A1 (en) Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 201080049144.6

Country of ref document: CN

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 10814608

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 2773048

Country of ref document: CA

Ref document number: 1989/CHENP/2012

Country of ref document: IN

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 2012528111

Country of ref document: JP

WWE Wipo information: entry into national phase

Ref document number: 2010814608

Country of ref document: EP