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

• US 10,265,486 B2
• Filed: 07/09/2015
• Issued: 04/23/2019
• Est. Priority Date: 09/03/2009
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Allum, Todd, Aguirre, Joey, Cipollone, Joseph, Eghbal, Darius, Kapust, Gregory, Wondka, Anthony
• Primary Examiner(s): Ho, Tan-Uyen T
• Assistant Examiner(s): Boecker, Joseph D.
• Application Number:
  US14/795,539
• Publication Number:
  US 20150314098A1
• Time in Patent Office: 1,384 Days
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0063 Compressors
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• CPC Class Codes: A61M 16/0672 Nasal cannula assemblies for oxygen therapy
• CPC Class Codes: A61M 16/0677 Gas-saving devices therefor
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/085 Gas sampling
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/127 by Venturi effect, i.e. entrainment mixers
• CPC Class Codes: A61M 16/16 Devices to humidify the respiration air A61M16/1045 takes precedence
• CPC Class Codes: A61M 16/161 with means for measuring the humidity
• CPC Class Codes: A61M 2016/0024 with an on-off output signal, e.g. from a switch
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/03 Gases in liquid phase, e.g. cryogenic liquids
• CPC Class Codes: A61M 2205/0216 : Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/0238 : the material being a coating or protective layer
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/42 : Reducing noise
• CPC Class Codes: A61M 2230/42 : Rate
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity

Abstract

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

Claims

1. A method comprising:

providing a nasal interface that allows a patient to breathe ambient air through the nasal interface, wherein the nasal interface comprises a gas flow path, wherein the gas flow path comprises a distal end gas flow path opening and a proximal end gas flow path opening;

providing a nozzle associated with a proximal end of the nasal interface at a distance from a nose;

providing an entrainment port associated with the nasal interface substantially between the nozzle and a distal end of the nasal interface, wherein at least a portion of the entrainment port is between the nozzle and the distal end gas flow opening; and

adapting the nozzle to be in fluid communication with a gas delivery circuit and a gas source, wherein the nozzle is capable of delivering gas into the nasal interface to create a negative pressure area in the gas flow path at the entrainment port, wherein the nasal interface and the nozzle create a positive pressure area between the entrainment port and the distal end of the nasal interface, and wherein a combination of gas from the gas source and air entrained through the entrainment port increases airway pressure,

wherein the gas flow path comprises a first section that is a substantially lateral-to-midline section and a second section distal to the first section that is a substantially inferior-to-superior section, and a curve between the two sections, with the positive pressure area substantially generated proximal to the curve.

2. The method of claim 1, further comprising a pressure sensing port terminating in a positive pressure region in the gas flow path.

3. The method of claim 1, wherein the gas flow path comprises a left gas flow path and a separate right gas flow path.

5. The method of claim 1, wherein a cross-sectional area of the gas flow path does not decrease from the entrainment port to the distal end gas flow opening.

6. The method of claim 1, wherein a cross-sectional area of the gas flow path is uniform from the entrainment port to the distal end gas flow opening.

7. The method of claim 1, wherein a cross-sectional area of the gas flow path increases from the entrainment port to the distal end gas flow opening.

8. The method of claim 1, wherein delivery of gas from the gas source is synchronized with an inspiratory phase.

9. The method of claim 1, wherein a time of delivery of gas from the gas source is modulated with respiratory rate to deliver a set volume at a different time and pressure amplitude based on a patient'"'"'s spontaneous respiratory rate.

10. The method of claim 1, wherein the nozzle and gas delivery tubing are attached to only one side of the nasal interface.

11. The method of claim 1, wherein the patient receives approximately 20-200% entrained air relative to gas from the gas source in the combination of gas from the gas source and the air entrained through the entrainment port.

12. The method of claim 1, wherein the nozzle comprises a tip, wherein at least a portion of the entrainment port is between the tip of the nozzle and the distal end gas flow path opening.

13. The method of claim 12, wherein the tip of the nozzle is located at a midpoint of the entrainment port.

14. The method of claim 1, wherein the negative pressure area is within the gas flow path.

15. The method of claim 14, wherein the negative pressure area extends from the entrainment port to a location proximal to the distal end of the nasal interface.

16. The method of claim 1, wherein the positive pressure area is within the gas flow path.

17. The method of claim 16, wherein the positive pressure area extends within the gas flow path from a location distal to the entrainment port to the distal end of the nasal interface.

18. The method of claim 1, wherein the combination of gas from the gas source and the air entrained through the entrainment port exits the nasal interface as laminar flow.

19. The method of claim 1, further comprising at least one sensor for measuring phases of breathing.

20. The method of claim 19, further comprising a ventilator, wherein the ventilator comprises a control unit, and wherein the control unit adjusts an output of the ventilator to match the patient'"'"'s ventilation needs based on information from the at least one sensor.

4. A method comprising:

providing a nasal interface that allows a patient to breathe ambient air through the nasal interface, wherein the nasal interface comprises a gas flow path, wherein the gas flow path comprises a distal end gas flow path opening and a proximal end gas flow path opening;

providing a nozzle associated with a proximal end of the nasal interface at a distance from a nose;

providing an entrainment port associated with the nasal interface substantially between the nozzle and a distal end of the nasal interface, wherein at least a portion of the entrainment port is between the nozzle and the distal end gas flow opening; and

adapting the nozzle to be in fluid communication with a gas delivery circuit and a gas source, wherein the nozzle is capable of delivering gas into the nasal interface to create a negative pressure area in the gas flow path at the entrainment port, wherein the nasal interface and the nozzle create a positive pressure area between the entrainment port and the distal end of the nasal interface, and wherein a combination of gas from the gas source and air entrained through the entrainment port increases airway pressure,

wherein the nasal interface comprises a manifold that is curved with a lateral-posterior-inferior curve on each side of a midline to position the manifold where most comfortable to the patient.

21. A method of delivering a therapeutic level of gas to a patient wherein the amount of gas increases the pressure in the oropharyngeal airway to a pressure level able to reduce obstructive sleep apnea airway obstructions, the method comprising:

a. attaching a nasal interface to a patient wherein the interface does not impede the patient from breathing ambient air directly through the interface;

b. placing a jet nozzle in the nasal interface at a proximal end of the interface lateral to the nose of the patient, and placing an entrainment port in the nasal interface between the jet nozzle and a distal end of the nasal interface;

c. attaching a ventilator to a gas delivery circuit and the gas delivery circuit to the jet nozzle and delivering gas from the ventilator to the nasal interface;

d. delivering the gas from the nozzle into the nasal interface with a velocity that creates a negative pressure inside the interface at the location of the entrainment port, at a distance from the interface distal end; and

e. configuring the interface to create a positive pressure between the negative pressure area in the nasal interface and the interface distal end, wherein substantially all of the patient'"'"'s exhaled gas flows through the entrainment port and virtually none flows through the gas delivery circuit, and wherein the therapeutic level of gas requires (a) gas from the ventilator and (b) ambient air entrained through the aperture by the velocity in the nasal interface created by the ventilation gas delivery.

22. The method of claim 21, further comprising monitoring the breathing pressure of the patient using an open airway pressure sensing port positioned between the entrainment port and the patient'"'"'s nose, in the zone of positive pressure in the interface distal to the entrainment zone in the interface.

23. The method of claim 21, further comprising providing the ventilator with an OFF-ON mode including a first power-on/gas-delivery-OFF state, and a second power-on/gas-delivery-ON state, the OFF state preceding the ON state and providing zero gas delivery, and the ON state providing the therapeutic gas delivery, and providing a delay between the gas delivery OFF and ON state, wherein the gas delivery OFF state is activated initially after the ventilator is powered on and the interface is connected to the patient, and where during the gas delivery OFF state the patient breathes ambient air freely through the interface, and wherein after a delay, the gas delivery ON state is activated, wherein the activation is selected from the group of:

(i) a predetermined time, (ii) a reduction in breath rate, (iii) a reduction in breathing pressure signal, (iv) a reduction in breathing pressure level, (v) a combination of the above.

24. The method of claim 21, further comprising delivering multiple amplitudes of gas to the patient, wherein the different amplitudes are synchronized with the spontaneous breathing pattern of the patient, wherein a first amplitude is the therapeutic level of gas delivered in synchrony with the inspiratory phase, and a second amplitude is delivered in synchrony with the expiratory phase, where the transition from the expiratory phase amplitude to the inspiratory phase amplitude begins in expiratory phase before inspiratory phase begins.

25. The method of claim 21, wherein greater than ⅓

of the gas delivered to the patient comes from the ventilator, and greater than ⅕

of the gas delivered to the patient comes from ambient air entrained through the entrainment port.

26. The method of claim 21, wherein the gas delivery pressure output from the ventilator is greater than 10 psi, wherein the flow rate output from the ventilator is less than 251pm, wherein the gas delivery circuit gas delivery channel internal diameter is less than 3 mm, and wherein the gas velocity exiting the nozzle is greater than 100 meters/second.

27. The method of claim 21, wherein humidified gas is delivered to the patient with a delivery circuit in parallel with the ventilator gas delivery circuit and wherein the humidified gas is added to the interface at the negative pressure entrainment zone.

28. The method of claim 21, wherein separate left and right breathing sensors are used to measure, monitor, process and track left nostril and right nostril breathing pressures separately.

29. The method of claim 21, wherein the gas is laminar when entering the nose by delivering the gas so that it exits the nozzle into the interface at high velocity of greater than 100 m/s, and enters the patient'"'"'s nose with the entrained air at low velocity of less than 50 m/sec.

30. A method of delivering a therapeutic level of gas to a patient wherein a delivered amount of gas increases pressure in an oropharyngeal airway to a pressure level able to reduce an obstructive sleep apnea airway obstruction, the method comprising:

a. providing a nasal interface that does not impede the patient from breathing ambient air directly through the nasal interface, wherein the nasal interface comprises;

i. a jet nozzle in the nasal interface at a proximal end of the nasal interface substantially lateral to a nose of the patient; and

ii. an entrainment port in the nasal interface substantially between the jet nozzle and a distal end of the nasal interface;

b. providing a ventilator and a gas delivery circuit, wherein the ventilator is in fluid communication with the jet nozzle via the gas delivery circuit; and

c. delivering gas from the jet nozzle into the nasal interface with a velocity that creates a negative pressure area inside the nasal interface at the location of the entrainment port, at a distance from the distal end of the nasal interface,

d. wherein the nasal interface is adapted to create a positive pressure area between the negative pressure area and the distal end of the nasal interface, and

e. wherein substantially all exhaled gas flows through the entrainment port and virtually none of the exhaled gas flows through the gas delivery circuit.

31. The method of claim 30, further comprising synchronizing delivery of gas with breathing of the patient.