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

• US 9,132,250 B2
• Filed: 09/03/2010
• Issued: 09/15/2015
• 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 D.
• Primary Examiner(s): Ho, Tan-Uyen T
• Assistant Examiner(s): BRYANT, ERIC C
• Application Number:
  US12/876,098
• Publication Number:
  US 20110214676A1
• Time in Patent Office: 1,838 Days
• Field of Search: None
• US Class Current: 1/1
• 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 system for providing ventilatory support comprising:

a gas source;

a gas delivery circuit;

a nasal interface adapted to allow a patient to breathe ambient air through the nasal interface;

a gas flow path through the nasal interface, wherein the gas flow path comprises a distal end gas flow path opening;

a nozzle positioned on a proximal end of the nasal interface at a distance from the distal end gas flow path opening; and

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

wherein the nozzle is in fluid communication with the gas delivery circuit and the gas source,

wherein the nozzle delivers 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 gas flow path, and

wherein a combination of gas from the gas source and air entrained through the entrainment port provide ventilatory support.

2. The system of claim 1, wherein the nasal interface includes a sound reducing feature.

3. The system of claim 2, wherein the sound reducing feature is angling the nozzle at an approximately 1-30 degree angle from a manifold gas flow path centerline axis.

4. The system of claim 2, wherein the sound reducing feature is an off-centered nozzle positioned off of the manifold gas flow path centerline by 5-25%.

5. The system of claim 2, wherein the sound reducing feature comprises a secondary gas flow exit that is separate from the entrainment port.

6. The system of claim 1, wherein sound generated by the nasal interface is <

50 db at 1 meter.

7. The system of claim 1, wherein the gas flow path comprises a first section that is a lateral-to-midline section and a second section distal to the first section that is a inferior-to-superior section, and a curve between the first section and the second section, with the positive pressure area generated proximal to the curve.

8. The system of claim 1, further comprising a pressure sensing port terminating in the positive pressure area in the gas flow path.

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

10. The system of claim 9, wherein the left gas flow path and the right gas flow path are pneumatically interconnected with an interconnecting channel.

11. The system of claim 1, further comprising a manifold, wherein the manifold is curved with a lateral-posterior-inferior curve on each side of a midline of the manifold to position the manifold where the manifold is most comfortable to the user.

12. The system of claim 1, further comprising a manifold, wherein the manifold includes at least one flex joint, and the at least one flex joint is located at a midline of the manifold.

13. The system of claim 12, wherein the manifold is made of a flexible material.

14. The system of claim 1, further comprising a manifold, and wherein the manifold is made of a malleable material to be shaped to a face of a user.

15. The system of claim 1, further comprising a manifold, and a space adjustment at a center of the manifold.

16. The system of claim 1, further comprising one or more nasal cushions attachable to the distal end gas flow opening, the one or more nasal cushions comprising a snap ring on pillows comprising a hard material, and a mating ring surrounding distal end gas flow openings.

17. The system of claim 1, further comprising one or more nasal cushions attachable to the distal end gas flow opening, the one or more nasal cushions comprising a rotatable connection to the nasal interface.

18. The system 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.

19. The system 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.

20. The system 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.

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

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

23. The system of claim 1, wherein the gas from the gas source is controlled by a wear-able ventilator.

24. The system of claim 1, wherein ventilatory support comprises reducing work of breathing to treat respiratory insufficiency.

25. The system of claim 1, wherein ventilatory support comprises elevating airway pressure to treat sleep apnea.

26. The system of claim 1, wherein the nozzle and gas delivery tubing is attached to only one side of the nasal interface.

27. The system of claim 1, wherein the gas flow path does not include abrupt angles.

28. The system of claim 27, wherein the abrupt angles are substantially 90 degrees.

29. The system of claim 1, wherein a 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.

30. The system 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 opening.

31. The system of claim 30, wherein the tip of the nozzle is located at a midpoint of the entrainment port.

32. The system of claim 30, wherein the tip of the nozzle is 5-60 mm from a centerline.

33. The system of claim 1, wherein the entertainment port is completely distal to the nozzle.

34. The system of claim 1, wherein the entrainment port has an average cross sectional area of approximately 0.035-0.095 square inches.

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

36. The system of claim 35, wherein the negative pressure area extends from the entrainment port to a location proximal to the distal end of the nasal interface.

37. The system of claim 1, wherein a negative pressure is less than ambient.

38. The system of claim 37, wherein the negative pressure is approximately −

5 to −

40 cmH₂O.

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

40. The system of claim 39, wherein the positive pressure area extends within the gas flow path from a location distal to the entrainment port the distal end of the nasal interface.

41. The system of claim 1, wherein the positive pressure is greater than ambient.

42. The system of claim 41, wherein the positive pressure is 0.01 to 0.50 psi.

43. The system of claim 1, wherein the combination of gas from the gas source and the air entrained through the entrainment port increase upper airway pressure by 2-35 cwp.

44. The system 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.

45. The system of claim 1, wherein the nasal interface has throat length of approximately −

0.75 to 2.0 inches.

46. The system of claim 1, wherein the gas delivery circuit has an inner diameter of less than 4 mm.

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

48. The system of claim 1, further comprising a ventilator, wherein the ventilator comprises a control unit, and wherein the control unit adjusts an output of the ventilator to match a patient'"'"'s ventilation needs based on information from the at least one sensor.

49. A system for increasing airway pressure, comprising:

a gas source;

a gas delivery circuit;

a nasal interface adapted to allow a patient to breathe ambient air through the nasal interface;

a gas flow path through the nasal interface, wherein the gas flow path comprises a distal end gas flow path opening;

a nozzle positioned on a proximal end of the nasal interface at a distance from the distal end gas flow path opening; and

wherein the nozzle is in fluid communication with the gas delivery circuit and the gas source,

wherein the nozzle delivers gas into the nasal interface to create a negative pressure area in the gas flow path near the proximal end of the nasal interface,

wherein the nasal interface and the nozzle create a positive pressure area within the gas flow path distal to the negative pressure area, and

wherein a combination of gas from the gas source and air entrained in the gas flow path increases airway pressure.

50. The system of claim 49, further comprising an entrainment port associated with the nasal interface, wherein at least a portion of the entrainment port is between the nozzle and the distal end gas flow opening.

51. The system of claim 50, wherein the negative pressure area extends from the entrainment port to a location proximal to the distal end of the nasal interface.

52. The system of claim 49, wherein a negative pressure is less than ambient.

53. The system of claim 52, wherein the negative pressure is −

10 to −

50 cmH₂O.

54. The system of claim 49, wherein the positive pressure is greater than ambient.

55. The system of claim 54, wherein the positive pressure is 2-30 cmH₂O.

56. A nasal interface for treating sleep apnea comprising a tubular body with a distal end and proximal end and a gas flow path extending from the distal end to the proximal end, wherein the tubular body curves laterally from a nostril distal end to the proximal end, and comprises:

a. a distal end configured to impinge a nostril airway;

b. an ambient air entrainment aperture in the tubular body between the proximal end and the distal end adapted to permit spontaneous breathing of ambient air directly through the ambient air entrainment aperture without impeding a user'"'"'s breathing;

c. a jet nozzle port positioned proximal to the ambient air entrainment aperture at the proximal end of the tubular body, and adapted to direct gas into the gas flow path and entrain air in from the ambient air entrainment aperture; and

d. a pressure sensing port,

wherein gas is configured to be delivered to a patient airway from a combination of the gas directed from the jet nozzle port and air entrained through the ambient air entrainment aperture, and wherein substantially all the gas exiting the user exits out of the ambient air entrainment aperture.

57. The nasal interface of claim 56, wherein the gas flow path comprises a length between the nozzle and distal end allowing a velocity profile exiting the jet nozzle port to merge with the walls of the gas flow path, and develop a positive pressure at a location proximal to the distal end and outside the nostril.

58. The nasal interface of claim 56, wherein the gas flow path has a minimum cross sectional area greater than or equal to a cross sectional area of the ambient air entrainment aperture.

59. The nasal interface of claim 56, wherein the ambient air entrainment aperture is positioned at an anterior side of the tubular body, to entrain airflow into the ambient air entrainment aperture from in front of a patient'"'"'s face, and to direct exhaled gas flowing out of the aperture away from the patient'"'"'s face.

60. The nasal interface of claim 56, wherein the tubular body includes a sound reducing feature selected from a group of:

a secondary port near the distal end, a nozzle position that is off-centered from the centerline axis of the tubular body, a nozzle angle that directs gas into the wall of the tubular body.

61. The nasal interface of claim 56, wherein the tubular body includes an internal volume of less than 0.40 cubic inches.

62. The nasal interface of claim 56, wherein the tubular body includes a gas flow resistance of less than 4 cmH2O pressure at 60 lpm gas flow.

63. The nasal interface of claim 56, wherein the pressure sensing port is positioned in the positive pressure area of the tubular body.

64. The nasal interface of claim 56, further comprising a left and a right tubular body, wherein each tubular body comprises a pressure sensing port.

65. The nasal interface of claim 56, further comprising an entrainment pressure sensing port located near the ambient air entrainment aperture, and a pressure sensing port located near the distal end.