TREATMENT OF RESPIRATORY CONDITIONS

• US 20110253136A1
• Filed: 05/28/2009
• Published: 10/20/2011
• Est. Priority Date: 06/05/2008
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Benjafield, Adam Vivian, Richards, Glenn, Klasek, Paul Jan, Heidmann, Dieter, Sweeney, Peter John, Farrugia, Steven Paul
• Granted Patent: US 10,350,379 B2
• Time in Patent Office: Days
• US Class Current: 128/203.12
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• 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 16/0688 by means of an adhesive
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/1095 in the connecting tubes
• 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 16/204 used for inhalation control
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8237 : Charging means

Abstract

A device (102) provides respiratory treatment for SDB (including mild OSA) and other respiratory conditions. A flow generator warms and humidifies gas at controlled flow levels. For example, the device (102) delivers breathable gas to the upper airway at flow rates of about 10-35 Liters/minute. Levels of flow rate, temperature and/or humidification of the device may be automatically adjusted in response to the detection of SDB events. The device may also automatically deliver adjustments of any of the levels in accordance with detected phases of respiratory cycles. In some embodiments, the device automatically delivers distinct levels to either of the nares based on independent control of flow to each nare. A warm-up procedure controls temperature and humidity at a desired target during a ramp-up of flow to the set therapy level. A cool-down procedure controls temperature above the dewpoint to avoid condensation internal to the device and patient interface.

Claims

1. A respiratory treatment apparatus comprising:

a flow generator to produce a flow of breathable gas through a patient interface at a first flow rate;

a humidifier in a path of the flow to humidify the breathable gas at a first humidity level;

a processor configured to control automatic adjustments to the first flow rate of the flow generator and to control automatic adjustments to the first humidity level.

2. The apparatus of claim 1 wherein the processor is configured to control the first flow rate in conjunction with an inspiratory phase of a respiratory cycle and a second flow rate in conjunction with an expiratory phase of the respiratory cycle.

3. The apparatus of claim 1 wherein the processor is configured to control the first humidity level in conjunction with an inspiratory phase of a respiratory cycle and a second humidity level in conjunction with an expiratory phase of the respiratory cycle.

4. The apparatus of claim 1 further comprising:

a heating element in a path of the flow to heat the breathable gas at a first temperature level,

wherein the processor is further configured to control the first temperature.

5. The apparatus of claim 4 wherein the processor is configured to control the first temperature level in conjunction with an inspiratory phase of a respiratory cycle and a second temperature level in conjunction with an expiratory phase of the respiratory cycle.

6. The apparatus of claim 1 further comprising:

a patient interface coupled with the flow generator, the patient interface comprising a first flow path and a second flow path, wherein each flow path is configured to be associated with a nare of a patient,

wherein the processor is configured to concurrently control the first flow rate through the first flow path and a second flow rate through the second flow path, and wherein the first flow rate and the second flow rate are different flow rates.

7. The apparatus of claim 6 wherein the flow generator comprises at least two blowers.

8. The apparatus of claim 6 wherein the flow generator comprises at least one blower and two flow channels, and wherein each flow channel includes an independent venting valve controlled by the processor.

9. The apparatus of claim 6 wherein the flow generator comprises at least one blower and two flow channels, and wherein a gate valve controlled by the processor regulates a division of flow from the blower to the flow channels.

10. The apparatus of claim 1 further comprising:

a patient interface coupled with the flow generator, the patient interface comprising a first flow path and a second flow path, wherein each flow path is configured to be associated with a nare of a patient,

wherein the processor is configured to concurrently control a first flow rate through the first flow path at a first humidity level and a second flow rate through the second flow path at a second humidity level, wherein the first humidity level and the second humidity level are different humidity levels.

11. The apparatus of claim 1 wherein the processor adjusts the first flow rate in response to the processor detecting one or more incidents of partial obstruction.

12. The apparatus of claim 1 wherein the processor adjusts the first flow rate in response to the processor detecting one or more incidents of apnea.

13. The apparatus of claim 1 wherein the processor adjusts the first flow rate in response to the processor detecting one or more incidents of snoring.

14. The apparatus of claim 1 wherein the processor adjusts the first humidity level in response to the processor detecting one or more incidents of partial obstruction.

15. The apparatus of claim 1 wherein the processor adjusts the first humidity level in response to the processor detecting one or more incidents of apnea.

16. The apparatus of claim 1 wherein the processor adjusts the first humidity level when the processor detects one or more incidents of snoring.

17. The apparatus of claim 1 wherein the processor comprises a warm-up procedure that sets a temperature of the breathable gas to a temperature set point and then gradually ramps the first flow rate from a start level flow rate to a therapy level flow rate while maintaining the temperature of the breathable gas within a margin of deviation from the temperature set point.

18. The apparatus of claim 1 wherein the processor comprises a warm-up procedure that sets a humidity of the breathable gas to a humidity set point and then gradually ramps the first flow rate from a start level flow rate to a therapy level flow rate while maintaining the humidity of the breathable gas within a margin of deviation from the humidity set point.

19. The apparatus of claim 1 further comprising:

a patient interface coupled with the flow generator, the patient interface comprising a delivery tube heating element,

wherein the processor is configured to control adjustments to the temperature setting of the delivery tube heating element.

20. The apparatus of claim 19 wherein the processor further comprises a cool-down procedure that disengages the humidifier operation and then controls a reduction of the first flow rate and a ramp down of one or more temperature settings of the one or more heating elements of the apparatus wherein controlled changes to the one or more temperature settings maintain the gas in the delivery tube in a margin of deviation above a dew-point temperature determined by the processor.

21. The apparatus of claim 1 further comprising:

a first flow channel, a second flow channel and a third flow channel coupled with the flow generator; and

a gate valve configured to direct a breathable gas flow to the third flow channel based from breathable gas from any of the first flow channel and the second flow channel,

wherein the processor controls a humidity level in the third flow channel by controlling a setting of the gate valve, and wherein a humidity level in the first flow channel is different from a humidity level in the second flow channel.

22. The apparatus of claim 1 further comprising:

a first flow channel, a second flow channel and a third flow channel coupled with the flow generator; and

a gate valve configured to direct a breathable gas flow to the third flow channel based from breathable gas from any of the first flow channel and the second flow channel,

wherein the processor controls a temperature level in the third flow channel by controlling a setting of the gate valve, and wherein a temperature level in the first flow channel is different from a temperature level in the second flow channel.

23. The apparatus of claim 1 further comprising a patient interface including a delivery tube, wherein the delivery tube comprises a gas flow channel that reduces in diameter substantially along a length of the delivery tube.

24. A method for control of a respiratory treatment apparatus, the method comprising:

producing a flow of breathable gas through a patient interface at a first flow rate with a flow generator;

in a path of the flow, humidifying the breathable gas at a first humidity level with a humidifier;

with a processor, controlling automatic adjustments to the first flow rate of the flow generator and controlling automatic adjustments to the first humidity level.

25. The method of claim 24 further comprising controlling the first flow rate in conjunction with an inspiratory phase of a respiratory cycle and a second flow rate in conjunction with an expiratory phase of the respiratory cycle.

26. The method of claim 24 further comprising controlling the first humidity level in conjunction with an inspiratory phase of a respiratory cycle and a second humidity level in conjunction with an expiratory phase of the respiratory cycle.

27. The method of claim 24 further comprising:

in a path of the flow, heating the breathable gas at a first temperature level with a heating element; and

with the processor, controlling the first temperature.

28. The method of claim 27 further comprising controlling the first temperature level in conjunction with an inspiratory phase of a respiratory cycle and a second temperature level in conjunction with an expiratory phase of the respiratory cycle.

29. The method of claim 24 further comprising:

directing a flow from the flow generator in a first flow path of a patient interface and a second flow path of a patient interface, wherein each flow path is configured to be associated with a nare of a patient, and

with the processor, concurrently controlling the first flow rate through the first flow path and a second flow rate through the second flow path,

wherein the first flow rate and the second flow rate are different flow rates.

30. The method of claim 29 wherein the concurrently controlling generates control signals for at least two blowers.

31. The method of claim 29 wherein the concurrently controlling generates control signals for at least one blower and first and second independent venting valves in first and second flow channels.

32. The method of claim 29 wherein the concurrently controlling generates control signals for at least one blower and a gate valve configured to set a division of flow from the blower between two flow channels.

33. The method of claim 24 further comprising:

directing breathable gas to a first flow path and a second flow path in a patient interface, wherein each flow path is associated with a nare of a patient; and

concurrently controlling the first flow rate through a first flow path at a first humidity level and a second flow rate through the second flow path at a second humidity level, wherein the first humidity level and the second humidity level are different humidity levels.

34. The method of claim 24 further comprising adjusting the first flow rate in response to automatically detecting one or more incidents of partial obstruction.

35. The method of claim 34 further comprising adjusting the first flow rate in response to automatically detecting one or more incidents of apnea.

36. The method of claim 24 further comprising adjusting the first flow rate in response to automatically detecting one or more incidents of snoring.

37. The method of claim 24 further comprising adjusting the first humidity level in response to automatically detecting one or more incidents of partial obstruction.

38. The method of claim 24 further comprising adjusting the first humidity level in response to automatically detecting one or more incidents of apnea.

39. The method of claim 24 further comprising adjusting the first humidity level in response to automatically detecting one or more incidents of snoring.

40. The method of claim 24 further comprising controlling a warm-up procedure that sets a temperature of the breathable gas to a temperature set point and then gradually ramps the first flow rate from a start level flow rate to a therapy level flow rate while maintaining the temperature of the breathable gas within a margin of deviation from the temperature set point.

41. The method of claim 24 further comprising controlling a warm-up procedure that sets a humidity of the breathable gas to a humidity set point and then gradually ramps the first flow rate from a start level flow rate to a therapy level flow rate while maintaining the humidity of the breathable gas within a margin of deviation from the humidity set point.

42. The method of claim 24 further comprising:

heating a heating element associated with a delivery tube of a patient interface that is coupled with a flow generator, and

controlling adjustments to a temperature setting of the heating element.

43. The method of claim 42 further comprising controlling a cool-down procedure that disengages the humidifier operation and then controlling a reduction of the first flow rate and a ramp down of one or more temperature settings of the one or more heating elements wherein controlled changes to the one or more temperature settings maintain breathable gas in the delivery tube in a margin of deviation above a dew-point temperature determined by the apparatus.

44. The method of claim 24 further comprising:

directing breathable gas in a first flow channel at a first humidity level and a second flow channel at a second humidity level different from the first humidity level; and

gating a breathable gas flow to a third flow channel at a third humidity level based from breathable gas from any of the first flow channel and the second flow channel,

controlling the third humidity level in the third flow channel by automatically controlling the gating.

45. The method of claim 24 further comprising:

directing breathable gas in a first flow channel at a first temperature level and a second flow channel at a second temperature level different from the first temperature level; and

gating a breathable gas flow to a third flow channel at a third temperature level based from breathable gas from any of the first flow channel and the second flow channel,

controlling the third temperature level in the third flow channel by automatically controlling the gating.

46. The method of claim 24 wherein breathable gas is delivered in a delivery tube of a patient interface to a patient along a gas flow channel that reduces in diameter substantially along a length of the delivery tube.

47. A system for providing respiratory therapy to a patient comprising:

a patient interface that is adapted to present a respiratory gas at an entrance to a patient'"'"'s airways;

an air delivery conduit connected to the patient interface;

a detector constructed and arranged to detect indications of sleep disordered breathing;

and apparatus to provide a controllable supply of air having a flow rate, a temperature and a humidity, the apparatus being controlled to vary at least one of flow rate, temperature and humidity in response to indications of sleep disordered breathing detected by the detector.

48. A system in accordance with claim 47 whereupon detection of flattening of an inspiratory flow-time curve, the flow rate of air delivered to the patient is increased.

49. A system in accordance with claim 48 wherein the amount of increase of flow rate is a function of the extent of flattening.

50. A system in accordance with claim 47 whereupon detection of a hypopnea, the flow rate of air delivered to the patient is increased.

51. A system in accordance with claim 47 whereupon detection of an apnea, the flow rate of air delivered to the patient is increased.

52. A system in accordance with claim 47 whereupon detection of snoring, the flow rate of air delivered to the patient is increased.

53. A system in accordance with claim 47 whereupon detection of flattening of an inspiratory flow-time curve, the humidity of air delivered to the patient is increased.

54. A system in accordance with claim 53 wherein the amount of increase of humidity is a function of the extent of flattening.

55. A system in accordance with claim 47 whereupon detection of a hypopnea, the humidity of air delivered to the patient is increased.

56. A system in accordance with claim 47 whereupon detection of an apnea, the humidity of air delivered to the patient is increased.

57. A system in accordance with claim 47 whereupon detection of snoring, the humidity of air delivered to the patient is increased.

58. A system in accordance with claim 47 whereupon detection of flattening of an inspiratory flow-time curve, the temperature of air delivered to the patient is increased.

59. A system in accordance with claim 58 wherein the amount of increase of temperature is a function of the extent of flattening.

60. A system in accordance with claim 47 whereupon detection of a hypopnea, the temperature of air delivered to the patient is increased.

61. A system in accordance with claim 47 whereupon detection of an apnea, the temperature of air delivered to the patient is increased.

62. A system in accordance with claim 47 whereupon detection of snoring, the temperature of air delivered to the patient is increased.

63. A system for providing respiratory therapy to a patient comprising:

a patient interface adapted to present a respiratory gas at an entrance to a patient'"'"'s airways;

an air delivery conduit connected to the patient interface; and

apparatus to provide a controllable supply of air having a flow rate, a temperature and a humidity, the apparatus being controlled to vary at least one of flow rate, temperature and humidity,

the apparatus being adapted to provide a first level of humidification during an inspiratory portion of a respiratory cycle of a patient and a second level of humidification during an expiratory portion of the respiratory cycle.

64. The system of claim 63 wherein the first level is higher than the second level.

65. The system of claim 63 wherein the apparatus is configured to provide a first level of temperature during an inspiratory portion of a respiratory cycle of a patient and a second level of temperature during an expiratory portion of the respiratory cycle.

66. The system of claim 65 wherein the first level of temperature is higher than the second level of temperature.

67. The system of claim 63 wherein the apparatus is configured to provide a first level of flow rate during an inspiratory portion of a respiratory cycle of a patient and a second level of flow rate during an expiratory portion of the respiratory cycle.

68. The system of claim 67 wherein the first level of flow rate is higher than the second level of flow rate.

69. A system for providing respiratory therapy to a patient comprising:

a patient interface adapted to present a respiratory gas at an entrance to a patient'"'"'s airways;

an air delivery conduit connected to the patient interface; and

apparatus being adapted to provide a controllable supply of air having a flow rate, a temperature and a humidity, the apparatus being controlled to vary at least one of flow rate, temperature and humidity,

the apparatus being adapted to provide a first level of temperature during an inspiratory portion of a respiratory cycle of a patient and a second level of temperature during an expiratory portion of the respiratory cycle.

70. The system of claim 69 wherein the first level is higher than the second level.

71. The system of claim 69 wherein the apparatus is configured to provide a first level of humidification during an inspiratory portion of a respiratory cycle of a patient and a second level of humidification during an expiratory portion of the respiratory cycle.

72. The system of claim 71 wherein the first level of humidification is higher than the second level of humidification.

73. The system of claim 69 wherein the apparatus is configured to provide a first level of flow rate during an inspiratory portion of a respiratory cycle of a patient and a second level of flow rate during an expiratory portion of the respiratory cycle.

74. The system of claim 73 wherein the first level of flow rate is higher than the second level of flow rate.

75. A system for providing respiratory therapy to a patient comprising:

a patient interface adapted to present a respiratory gas at an entrance to a patient'"'"'s airways, the interface comprising a first flow path associated with a first nare and second flow path associated with a second nare; and

apparatus to provide a controllable supply of air having a flow rate, a temperature and a humidity, the apparatus being controlled to vary at least one of flow rate, temperature and humidity,

the apparatus being adapted to control the first flow path independently from the second flow path with respect to any of the flow rate, temperature and humidity of each of the first flow path and second flow path.

76. The system of claim 75 wherein the apparatus is configured to deliver a first humidity level to the first flow path and a second humidity level to the second flow path, wherein the first humidity level is different from the second humidity level.

77. The system of claim 75 wherein the apparatus is configured to deliver a first temperature level to the first flow path and a second temperature level to the second flow path, wherein the first temperature level is different from the second temperature level.

78. The system of claim 75 wherein the apparatus is configured to deliver a first flow rate to the first flow path and a second flow rate to the second flow path, wherein the first flow rate is different from the second flow rate.

79. A system for providing respiratory therapy to a patient comprising:

a patient interface adapted to present a respiratory gas at an entrance to a patient'"'"'s airways;

an air delivery conduit connected to the patient interface; and

apparatus to provide a controllable supply of air having a flow rate, a temperature and a humidity, the apparatus being controlled to vary at least one of flow rate, temperature and humidity,

the apparatus being adapted to control gradual ramping of the flow rate of air from an initial flow rate to a therapy flow rate, the ramping of flow rate occurring over a preset period of time while a therapy level of temperature and humidity of the air is maintained within a preset margin of deviation from a therapy level setting of temperature and humidity.

80. A system for providing respiratory therapy to a patient comprising:

a patient interface adapted to present a respiratory gas at an entrance to a patient'"'"'s airways, the interface comprising a first flow path associated with a first nare and second flow path associated with a second nare;

apparatus to provide a controllable supply of air having a flow rate, a temperature and a humidity, the apparatus being controlled to vary at least one of flow rate, temperature and humidity,

the apparatus being adapted to control ramping of the temperature and humidity of air from a therapy level to an ambient level, the ramping occurring over a period of time while the apparatus controls the temperature of the air within a preset margin of deviation above a dewpoint temperature.

81. The system of claim 80 wherein the apparatus controls a reduction of the flow rate from a therapy flow rate level for the ramping of the temperature and humidity.

82. An apparatus to provide a respiratory therapy to a patient comprising:

a flow generator to generate a flow of breathable gas at a therapeutic flow rate for a patient interface;

a humidifier and heater to heat and humidify the flow of breathable gas; and

a controller to control a ramp procedure initiated by user activation of an input device of the apparatus, the re-ramp procedure comprising the apparatus delivering a ramp flow rate during a ramp period and delivering the therapeutic flow rate after the ramp period, wherein the ramp flow rate is lower than the therapeutic flow rate, and wherein the ramp period is a time period greater than several breaths, and wherein the controller controls the ramp procedure as a function of a humidification or temperature state of the breathable gas.

83. The apparatus of claim 82 wherein the apparatus further comprises an exhaust valve to exhaust a portion of the breathable gas at the therapeutic flow rate away from the patient interface so as to deliver the ramp flow rate to the patient interface.

84. The apparatus of claim 83 wherein the humidification or temperature state comprises completion of a warm-up procedure with the apparatus.

85. A patient interface device for a respiratory treatment apparatus to direct a flow of breathable gas to the respiratory system of a patient comprising:

a coupling for a breathable gas delivery hose,

a gas directing outlet portion to direct a flow of breathable gas to nares of a patient; and

a nasal dilator mount portion.

86. The patient interface device of claim 85 wherein the mount portion comprises a gap configured to receive a removable nasal dilator strip.

87. The patient interface device of claim 85 wherein the mount portion comprises a set of nasal dilator extension members coupled to the mount portion.

88. The patient interface device of claim 87 wherein a nasal dilator extension member is configured to provide an extension force against an internal surface of a nare to dilate the nare.

89. The patient interface device of claim 87 wherein a nasal dilator extension member is configured to provide an extension force at an external surface of a nose to dilate a nare of the nose.

90. The patient interface device of claim 87 wherein the device comprises a cannula and the gas directing outlet portion comprises a set of nasal prongs.

91. A patient interface device for a respiratory treatment apparatus to direct a flow of breathable gas to the respiratory system of a patient comprising:

a coupling for connection of a breathable gas delivery hose, and

a gas directing outlet portion to direct a flow of breathable gas to nares of a patient;

wherein the coupling comprises a swivel configured for relative rotation between the breathable gas delivery hose and the gas directing outlet aperture portion.

92. The patient interface device of claim 91 wherein the swivel is configured for relative rotation between the breathable gas delivery hose and the gas directing outlet aperture portion about a plurality of perpendicular axes.

93. The patient interface device of claim 91 wherein the patient interface device further comprises a nasal dilator mount portion.

94. An apparatus to direct a flow of breathable gas to the respiratory system of a patient comprising:

a patient interface adapted to engage nares, wherein the patient interface is adapted not to seal against a patient'"'"'s face, wherein the patient interface is also connectable to a flow generator,

a flow generator to produce a flow of breathable gas through a patient interface at a first flow rate;

a controller and at least one sensor are configured to reduce or stop first flow rate, if the sensor detects a disengagement of the patient interface from nares.

95. An apparatus to direct a flow of breathable gas to the respiratory system of a patient comprising:

a patient interface adapted to engage the nares, wherein the patient interface is adapted not to seal against a patient'"'"'s face, wherein the patient interface is also connected to a flow generator,

a flow generator to produce a flow of breathable gas through a patient interface at a first flow rate;

the patient interface includes an air diffuser on or proximal to an end of the patient interface engaging the nares.

96. An apparatus to direct a flow of breathable gas to the respiratory system of a patient comprising:

a patient interface adapted to engage the nares, wherein the patient interface is adapted not to seal against a patient'"'"'s face, wherein the patient interface is also connected to a flow generator,

a flow generator to produce a flow of breathable gas through a patient interface at a first flow rate;

the patient interface includes a clip adapted to engage the nares.

97. An apparatus to direct a flow of breathable gas to the respiratory system of a patient comprising:

a patient interface adapted to engage the nares, wherein the patient interface is adapted not to seal against a patient'"'"'s face, wherein the patient interface is also connected to a flow generator,

a flow generator to produce a flow of breathable gas through a patient interface at a first flow rate;

the patient interface includes an baffle on or proximal to an end of the patient interface engaging the nares.