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

• US 9,962,512 B2
• Filed: 09/03/2010
• Issued: 05/08/2018
• Est. Priority Date: 04/02/2009
• Status: Active Grant

• Current Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Original Assignee: Breathe Technologies, Inc. (Baxter International Inc.)
• Inventors: Cipollone, Joseph, Aguirre, Joey, Allum, Todd, Eghbal, Darius, Wondka, Anthony D.
• Primary Examiner(s): Ho, (Jackie) Tan-Uyen T
• Assistant Examiner(s): Boecker, Joseph D
• Application Number:
  US12/876,099
• Publication Number:
  US 20110094518A1
• Time in Patent Office: 2,804 Days
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• 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 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0688 by means of an adhesive
• 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 16/101 using an oxygen concentrator
• 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 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0024 with an on-off output signal, e.g. from a switch
• 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 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/8206 battery-operated

Abstract

A system for supplying ventilatory support may include 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 may be associated with the nasal interface at a distance from a nose. The nozzle may be connectable to the gas delivery circuit and the gas delivery source. The nozzle may be 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. A combination of gas from the gas delivery source and air entrained from the gas exiting the nozzle may provide ventilatory support.

Claims

1. A system for supplying ventilatory support, comprising:

a gas delivery source;

a gas delivery circuit;

a non-sealing nasal interface configured to be placed under a nose of a patient and to communicate with the patient'"'"'s nostril airway while allowing the patient to breathe ambient air;

a nozzle associated with the non-sealing nasal interface and configured to be positioned a distance from a nostril entrance of the patient'"'"'s nostril airway when the non-sealing nasal interface is placed under the nose of the patient, the nozzle being connectable to the gas delivery circuit and the gas delivery source;

wherein the nozzle is configured to deliver a gas flow cone defined by the gas exiting the nozzle, such that when the non-sealing nasal interface is placed under the nose of the patient, the gas flow cone intersects with an internal wall of the patient'"'"'s nostril airway at an intersecting point, the area inside the gas flow cone and the area within the patient'"'"'s nostril airway distal to the intersecting point defining a positive pressure area wherein a laminar positive pressure flow is developed, the area outside the gas flow cone defining a negative pressure area entraining ambient air into the patient'"'"'s nostril airway; and

wherein a combination of gas from the gas delivery source and air entrained into the patient'"'"'s nostril airway provide ventilatory support.

2. The system of claim 1, wherein the non-sealing nasal interface comprises a manifold, and wherein the manifold comprises the nozzle.

3. The system of claim 2, wherein the manifold is configured to position the nozzle at the distance away from the nostril entrance, and configured to position the nozzle at an angle relative a centerline of the nostril airway.

4. The system of claim 1, further comprising one or more sensors.

5. The system of claim 4, 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.

6. The system of claim 4, wherein the one or more sensors comprise a sensing channel that extends distally away from the nozzle.

7. The system of claim 6, wherein the sensing channel extends into the nose of the patient.

8. The system of claim 6, wherein the sensing channel extends to within approximately +/−

5 mm from the nostril entrance.

9. The system of claim 1, further comprising two or more nozzles per nostril.

10. The system of claim 1, wherein the nozzle is an oval-shaped gas delivery nozzle orifice.

11. The system of claim 1, wherein the nozzle comprises an array of multiple gas delivery nozzles arranged in a circular or oval pattern.

12. The system of claim 1, further comprising a jet pump throat comprising a flow path.

13. The system of claim 12, 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.

14. The system of claim 13, wherein the manifold comprises an entrainment port in communication with the jet pump throat flow path.

15. The system of claim 1, wherein the nozzle angles inward.

16. The system of claim 15, wherein the nozzle angles inward at an angle of 1 degree to 20 degrees.

17. The system of claim 1, wherein the nozzle creates an oval shaped gas flow cone within a nostril airway.

18. The system of claim 17, wherein the nozzle is rotatably adjustable.

19. The system of claim 1, wherein the nozzle comprises 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.

20. The system of claim 19, wherein the at least one left nozzle and the at least one right nozzle are rotatably adjustable.

21. The system of claim 1, wherein spacing between the nostril entrance and nozzle is adjustable.

22. The system of claim 1, wherein the non-sealing nasal interface is available in different sizes, differing in nozzle spacing, nozzle rotational orientation and nozzle distance to nostril entrance.

23. The system of claim 1, wherein a negative pressure of the negative pressure area is less than ambient.

24. The system of claim 23, wherein the negative pressure of the negative pressure area is −

5 cmH₂O to −

28 cmH₂O.

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

26. The system of claim 25, wherein the positive pressure of the positive pressure area is approximately 0.01 psi to approximately 0.50 psi.

27. The system of claim 1, wherein the nozzle is positioned at a distance of up to 1.5 inches from the nostril entrance of the patient'"'"'s nostril airway when the non-sealing nasal interface is placed under the nose of the patient.

28. The system of claim 1, wherein delivery of gas through the nozzle is synchronized with a breathing pattern of the patient.

29. The system of claim 1, wherein the gas from the gas delivery source is controlled by a wearable ventilator.

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

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

32. The system of claim 1, wherein the non-sealing nasal interface comprises a connector for coupling the system to a bridge of the nose and aligning the nozzle with the nostril entrance of the patient'"'"'s nostril airway.

33. The system of claim 32, wherein the aligning of the nozzle with the nostril entrance of the patient'"'"'s nostril airway comprises adjusting the angle of the nozzle to be in alignment with the centerline of the nostril airway.

34. A method for providing portable non-invasive open-airway ventilatory support, the method comprising:

providing a non-sealing nasal interface configured to be placed under a nose of a patient and to communicate with the patient'"'"'s nostril airway while allowing the patient to breathe ambient air; and

providing a nozzle associated with the non-sealing nasal interface and configured to be positioned a distance from a nostril entrance of the patient'"'"'s nostril airway when the non-sealing nasal interface is placed under the nose of the patient, the nozzle being adapted to be in fluid communication with a gas delivery circuit and a gas delivery source;

wherein the nozzle is of configured to deliver a gas flow cone defined by the gas exiting the nozzle, such that when the non-sealing nasal interface is placed under the nose of the patient, the gas flow cone intersects with an internal wall of the patient'"'"'s nostril airway at an intersecting point, the area inside the gas flow cone and the area within the patient'"'"'s nostril airway distal to the intersecting point defining a positive pressure area wherein a laminar positive pressure flow is developed, the area outside the gas flow cone defining a negative pressure area entraining ambient air into the patient'"'"'s nostril airway;

wherein a combination of gas from the gas delivery source and air entrained into the patient'"'"'s nostril airway provides ventilatory support.

35. The method of claim 34, wherein the non-sealing nasal interface comprises a manifold, and wherein the manifold comprises the nozzle.

36. The method of claim 35, wherein the manifold is configured to position the nozzle at the distance away from the nostril entrance, and configured to position the nozzle at an angle relative a centerline of the nostril airway.

37. The method of claim 34, further comprising one or more sensors.

38. The method of claim 37, 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.

39. The method of claim 37, wherein the one or more sensors comprise a sensing channel that extends distally away from the nozzle.

40. The method of claim 39, wherein the sensing channel extends into the nose of the patient.

41. The method of claim 39, wherein the sensing channel extends to within +/−

5 mm from the nostril entrance.

42. The method of claim 34, further comprising two or more nozzles per nostril.

43. The method of claim 34, wherein the nozzle is an oval-shaped gas delivery nozzle orifice.

44. The method of claim 34, wherein the nozzle comprises an array of multiple gas delivery nozzles arranged in a circular or oval pattern.

45. The method of claim 34, further comprising a jet pump throat comprising a flow path.

46. The method of claim 45, 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.

47. The method of claim 46, wherein the manifold comprises an entrainment port in communication with the jet pump throat flow path.

48. The method of claim 34, wherein the nozzle angles inward.

49. The method of claim 48, wherein the nozzle angles inward at an angle of 1 degree to 20 degrees.

50. The method of claim 34, wherein the nozzle creates an oval shaped gas flow cone within the nostril airway.

51. The method of claim 50, wherein the nozzle is rotatably adjustable.

52. The method of claim 34, wherein the nozzle comprises 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.

53. The method of claim 52, wherein the at least one left nozzle and the at least one right nozzle are rotate-ably adjustable.

54. The method of claim 34, wherein spacing between the nostril entrance and nozzle is adjustable.

55. The method of claim 34, wherein the non-sealing nasal interface is available in different sizes, differing in nozzle spacing, nozzle rotational orientation and nozzle distance to nostril entrance.

56. The method of claim 34, wherein the negative pressure of the negative pressure area is less than ambient.

57. The method of claim 56, wherein the negative pressure of the negative pressure area is −

5 cmH₂O to −

28 cmH₂O.

58. The method of claim 34, wherein the positive pressure of the positive pressure area is greater than ambient.

59. The method of claim 58, wherein the positive pressure of the positive pressure area is 0.01 psi to 0.50 psi.

60. The method of claim 34, wherein the nozzle is positioned at a distance of up to 1.5 inches from the nostril entrance of the patient'"'"'s nostril airway when the non-sealing nasal interface is placed under the nose of the patient.

61. The method of claim 34, wherein delivery of gas through the nozzle is synchronized with a breathing pattern of the patient.

62. The method of claim 34, wherein the gas from the gas delivery source is controlled by a wearable ventilator.

63. The method of claim 34, wherein ventilatory support comprises reducing the work of breathing to treat respiratory insufficiency.

64. The method of claim 34, wherein ventilatory support comprises elevating airway pressure to treat sleep apnea.

65. The method of claim 34, wherein the non-sealing nasal interface comprises a connector for coupling the system to a bridge of the nose and aligning the nozzle with the nostril entrance of the patient'"'"'s nostril airway.

66. The method of claim 65, wherein the aligning of the nozzle with the nostril entrance of the patient'"'"'s nostril airway comprises adjusting the angle of the nozzle to be in alignment with a centerline of the nostril airway.