Acclimatization therapy for first time users

• US 20090038616A1
• Filed: 09/05/2008
• Published: 02/12/2009
• Est. Priority Date: 06/14/2005
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Somerville, William McInnes, Vorreiter, David Richard, Kwok, Philip Rodney, Mulcahy, David
• Granted Patent: US 8,528,551 B2
• Time in Patent Office: Days
• US Class Current: 128/204.230
• CPC Class Codes: A61M 16/0051 with alarm devices
• 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 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0875 Connecting tubes
• 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 2016/003 with a flowmeter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2230/40 Respiratory characteristics

Abstract

Systems, methods, and/or apparatuses for acclimatizing a user to positive airway pressure (PAP) therapy are provided. Generally, a sub-therapeutic treatment pressure is provided initially. It may be ramped up to a full treatment pressure over the course of one or more therapy sessions. The pressure level may be ramped up based on, for example, sleep state, sleep phase, patient compliance with types of treatment (e.g. bilevel vs. CPAP, etc.), clinician input (either at the site, remotely, via pre-programmed smartcards, etc.), etc. Such techniques may be used alone or in combination.

Claims

1. A method of acclimatizing a patient to CPAP therapy for treatment of sleep-disordered breathing, the method comprising:

providing a device configured to supply pressurized breathable gas to the patient; and

, providing at least one smartcard, each smartcard having treatment parameters stored thereon;

wherein the device is configured to accept the at least one smartcard and to provide the supply of pressurized breathable gas based on the treatment parameters stored thereon.

2. The method of claim 1, further comprising programming the smartcard with a pressure setting, the device being operable to supply the breathable gas at the pressure setting.

3. The method of claim 1, further comprising programming the smartcard with a limited pressure setting, a full therapeutic pressure setting greater than the limited pressure setting, and/or ramp up information, the ramp up information including the rate at and/or time period over which the device should adjust the pressure of the breathable gas from the limited pressure setting to the full treatment pressure setting.

4. The method of claim 1, further comprising programming the smartcard with duration data, the duration data indicating a time and/or a predetermined number of uses after which the smartcard becomes inactive, the device being operable to supply the breathable gas in dependence on the duration data.

5. The method of claim 1, further comprising programming at least two smartcards, each smartcard being programmed with different sets of treatment parameters.

6. The method of claim 5, further comprising using the at least two smartcards in a predetermined order.

7. The method of claim 1, further comprising storing patient compliance data from the device on the smartcard.

8. The method of claim 7, further comprising providing the supply of breathable gas further based on the patient compliance data.

9. A CPAP device for acclimatizing a patient to treatment of sleep-disordered breathing, the CPAP device being operable to provide a supply pressurized breathable gas to the patient based on treatment parameters stored on a smartcard, the smartcard being readable by the CPAP device.

10. The CPAP device of claim 9, wherein the smartcard comprises a pressure setting, the device being operable to supply the breathable gas at the pressure setting.

11. The CPAP device of claim 9, wherein the treatment parameters comprise a limited pressure setting, a full treatment pressure setting greater than the limited pressure setting, and/or ramp up information, the ramp up information including the rate at and/or time period over which the device should adjust the pressure of the breathable gas from the limited pressure setting to the full treatment pressure setting.

12. The CPAP device of claim 9, wherein the device is configured to provide the supply of pressurized breathable gas further based on duration data stored on the smartcard, the duration data indicating a time and/or a predetermined number of uses after which the smartcard becomes inactive.

13. The CPAP device of claim 9, wherein at least two smartcards are provided, each smartcard having a different set of treatment parameters stored thereon.

14. The CPAP device of claim 13, wherein the at least two smartcards are configured to be used in a predetermined order.

15. The CPAP device of claim 9, wherein the device is configured to store patient compliance data on the smartcard.

16. The CPAP device of claim 15, wherein the device is configured to provide the supply of breathable gas further based on the patient compliance data.

17. A smartcard for use with a device operable to provide a supply of pressurized breathable gas to a patient, the smartcard having treatment parameters stored thereon, the treatment parameters comprising a pressure setting to be supplied to the device.

18. The smartcard of claim 17, wherein the treatment parameters comprise a limited pressure setting, a full treatment pressure setting greater than the limited pressure setting, and/or ramp up information, the ramp up information including the rate at and/or time period over which the device should adjust the pressure of the breathable gas from the limited pressure setting to the full treatment pressure setting.

19. The smartcard of claim 17, further comprising duration data, the duration data indicating a time and/or a predetermined number of uses after which the smartcard becomes inactive.

20. A method of acclimatizing a patient to CPAP therapy for treatment of sleep-disordered breathing, the method comprising:

providing a device configured to supply pressurized breathable gas to the patient;

identifying target CPAP treatment parameters to be used when treating the patient, the target CPAP treatment parameters comprising a full treatment pressure to be delivered to the patient during patient inspiration and patient expiration;

providing a bilevel treatment, the bilevel treatment comprising providing IPAP therapy and/or EPAP therapy;

ramping up parameters associated with the IPAP therapy and/or parameters associated with the EPAP therapy until the target CPAP treatment parameters are met.

21. The method of claim 20, further comprising independently ramping up the parameters associated with the IPAP therapy and the parameters associated with the EPAP therapy.

22. The method of claim 20, further comprising setting the IPAP therapy to a pressure higher than the EPAP therapy.

23. A PAP device for acclimatizing a patient to treatment of sleep-disordered breathing, comprising:

a flow generator operable in acclimatization and CPAP modes to provide a supply of pressurized breathable gas to the patient;

a controller operable to instruct the flow generator, in the acclimatization mode, to provide the breathable gas at a first pressure during patient inspiration, and to provide the breathable gas at a second pressure during patient expiration, the second pressure being different from the first pressure;

wherein the controller is operable to adjust the first pressure and/or the second pressure until a target CPAP therapy is provided at which point the flow generator operates in the CPAP mode, the target CPAP therapy having a full treatment pressure to be delivered to the patient during patient inspiration and patient expiration associated therewith.

24. The PAP device of claim 23, wherein the controller is configured to adjust the first pressure and the second pressure independently.

25. The PAP device of claim 23, wherein the first pressure is higher than the second pressure during an initial portion in the acclimatization mode.

26. A method of acclimatizing a patient to therapy for treatment of sleep-disordered breathing, the method comprising:

continuously monitoring at least one parameter of the patient;

associating the at least one parameter with a continuously adjusting treatment pressure for the patient; and

,

providing a supply of pressurized breathable gas to the patient at a continuously adjusting pressure based on the at least one parameter;

wherein the breathable gas initially is provided at an adjustable limited pressure, the limited pressure being below the treatment pressure, and

further wherein the limited pressure is ramped up during the treatment until the limited pressure equals the treatment pressure.

27. A PAP device for acclimatizing a patient to treatment of sleep-disordered breathing, comprising:

a monitor operable to continuously monitor at least one parameter of the patient;

a processor operable to associate the at least one parameter with a continuously adjusting treatment pressure; and

a flow generator operable to provide a supply of pressurized breathable gas to the patient at a continuously adjusting pressure based on the at least one parameter;

wherein the flow generator is configured to provide the breathable gas at the treatment pressure and at a limited pressure, the limited pressure being below the treatment pressure, and

further wherein the flow generator is operable to ramp up the limited pressure until the limited pressure equals the treatment pressure.

28. A method of acclimatizing a patient to therapy for treatment of sleep-disordered breathing, the method comprising:

monitoring at least one parameter of the patient;

associating the at least one parameter with a treatment pressure for the patient;

providing a supply of pressurized breathable gas at the treatment pressure to the patient;

detecting one or more obstructive events during the treatment; and

,

for each obstructive event detected, incrementally increasing the treatment pressure a predetermined amount.

29. The method of claim 28, wherein the obstructive event is an apnea.

30. The method of claim 28, wherein the treatment pressure is variably incremented for each obstructive event detected.

31. The method of claim 28, wherein the treatment pressure is incrementally increased by 0.5 cmH₂O for each obstructive event detected.

32. A PAP device for acclimatizing a patient to treatment of sleep-disordered breathing, comprising:

a monitor operable to monitor at least one parameter of the patient and operable to detect one or more obstructive events during treatment;

a processor operable to associate the at least one parameter with a treatment pressure; and

a flow generator operable to provide a supply of pressurized breathable gas to the patient;

wherein the flow generator is configured to incrementally increase the treatment pressure a predetermined amount for each obstructive event detected by the monitor.

33. The PAP device of claim 32, wherein the obstructive event is an apnea.

34. The PAP device of claim 32, wherein the treatment pressure is incrementally increased by 0.5 cmH₂O for each obstructive event detected.

35. The PAP device of claim 32, wherein the treatment pressure is variably incremented for each obstructive event detected.

36. A method of acclimatizing a patient to therapy for treatment of sleep-disordered breathing, the method comprising:

observing the patient to determine a full treatment pressure appropriate for the patient;

determining a limited treatment pressure less than the full treatment pressure;

providing a supply of pressurized breathable gas to the patient at the limited treatment pressure;

monitoring at least one parameter of the patient, the at least one parameter corresponding to patient acceptance of the treatment; and

,

communicating the at least one parameter to a sleep clinician via a computer-mediated communication channel, the sleep clinician being located remote from the patient.

37. The method of claim 36, further comprising adjusting the limited treatment pressure based on a determination made by the sleep clinician, the adjustment being made from the location remote from the patient.

38. The method of claim 36, wherein the limited treatment pressure is increased to a pressure less than or equal to the full treatment pressure.

39. A system for acclimatizing a patient to therapy for treatment of sleep-disordered breathing, comprising:

a flow generator operable to provide a supply of pressurized breathable gas to the patient at a plurality of pressures;

a sensor operable to monitor at least one parameter of the patient; and

,

a first communicator operable to send the at least one parameter to a sleep clinician, and further operable to receive at least one treatment parameter from the sleep clinician;

wherein the sleep clinician is located remote from the patient, and

wherein the pressure of the breathable gas initially is provided at a limited treatment pressure less than a full treatment pressure appropriate for the patient.

40. The system of claim 39, wherein the pressure of the breathable gas optionally is adjusted based on the treatment parameter received from the sleep clinician.

41. The system of claim 39, wherein the flow generator is configured to increase the limited treatment pressure to a pressure less than or equal to the full treatment pressure.

42. A method of acclimatizing a patient to therapy for treatment of sleep-disordered breathing, the method comprising:

providing a supply of pressurized breathable gas through a tube to a mask, the mask having an opening therein, the opening allowing controlled mask leak; and

,

adjusting a size of the opening to alter an amount of mask leak and cause a corresponding change in the breathable gas pressure;

wherein the size of the opening is adjusted to vary a pressure of the breathable gas between a full treatment pressure and a limited pressure, the limited pressure being less than the full treatment pressure.

43. The method of claim 42, further comprising preventing the size of the opening from being subsequently increased.

44. A mask for use by a patient during therapy for treatment of sleep-disordered breathing, the mask being configured to receive a supply of pressurized breathable gas from a tube connected to a flow generator, comprising:

an opening, the opening allowing controlled mask leak; and

,

an adjustment mechanism for adjusting a size of the opening to alter an amount of mask leak and for causing a corresponding change in the breathable gas pressure;

wherein the size of the opening is configured to be adjusted to vary a pressure of the breathable gas between a full treatment pressure and a limited pressure, the limited pressure being less than the full treatment pressure.

45. The mask of claim 44, wherein the opening comprises one or more vent holes.

46. The mask of claim 44, wherein the adjustment mechanism prevents the size of the opening from being increased.

47. A system for acclimatizing a patient to therapy for treatment of sleep-disordered breathing, comprising:

a flow generator operable to provide a supply of pressurized breathable gas to the patient through a flexible tube connected to a mask;

wherein the mask comprises;

an opening, the opening allowing controlled mask leak; and

,

an adjustment mechanism for adjusting a size of the opening to alter an amount of mask leak and for causing a corresponding change in the breathable gas pressure;

wherein the size of the opening is configured to be adjusted to vary a pressure of the breathable gas between a full treatment pressure and a limited pressure, the limited pressure being less than the full treatment pressure.

48. The system of claim 47, wherein the adjustment mechanism prevents the size of the opening from being increased.

49. A method of acclimatizing a patient to therapy for treatment of sleep-disordered breathing, the method comprising:

identifying a plurality of full treatment pressures, each full treatment pressure being associated with a sleep stage;

determining the sleep stage of the patient; and

,

providing a supply of pressurized breathable gas to the patient in dependence on the sleep stage of the patient.

50. The method of claim 49, wherein a first pressure provided to the patient during a comparatively active sleep stage is lower than a second pressure provided to the patient during a comparatively inactive sleep state.

51. The method of claim 50, wherein the comparatively active sleep stage is REM sleep, and the comparatively inactive sleep stage is NREM sleep.

52. The method of claim 49, further comprising for each sleep stage,

providing the breathable gas at a limited pressure lower than a full treatment pressure;

and,

ramping up the pressure of the breathable gas from the limited pressure to the full treatment pressure.

53. The method of claim 49, wherein the supply of breathable gas is provided at a low pressure when the patient is awake.

54. A PAP device for acclimatizing a patient to therapy for treatment of sleep-disordered breathing, comprising:

a sensor for determining a sleep stage of the patient, each sleep stage having a treatment pressure associated therewith;

a flow generator operable to, provide a supply of pressurized breathable gas to the patient in dependence on the sleep stage of the patient and configured to adjust the treatment pressure of the breathable gas if the sensor determines that the sleep stage of the patient changes.

55. The PAP device of claim 54, wherein a first pressure provided to the patient during a comparatively active sleep stage is lower than a second pressure provided to the patient during a comparatively inactive sleep state.

56. The PAP device of claim 55, wherein the comparatively active sleep stage is REM sleep, and the comparatively inactive sleep stage is NREM sleep.

57. The PAP device of claim 54, wherein the flow generator is further configured, for each sleep stage, to initially provide the breathable gas at a limited pressure lower than the treatment pressure associated with the sleep stage, and ramp up the pressure of the breathable gas from the limited pressure to the treatment pressure associated with the sleep stage.

58. The PAP device of claim 54, wherein the flow generator provides the breathable gas at a low pressure when the sensor indicates that the patient is awake.

59. A method of acclimatizing a patient to therapy for treatment of sleep-disordered breathing, the method comprising:

providing a supply of pressurized breathable gas to the patient for a predetermined settling time at a limited pressure;

providing the breathable gas at a full treatment pressure after the predetermined settling time;

wherein the limited pressure is lower than the full treatment pressure.

60. The method of claim 59, wherein the predetermined settling time corresponds to an amount of time it takes the patient to fall asleep.

61. The method of claim 59, wherein the breathable gas is provided at a pressure lower than the limited pressure, the pressure being ramped up to the limited pressure during the predetermined settling time.

62. The method of claim 59, wherein after the predetermined settling time, the breathable gas is provided at a pressure lower than the full treatment pressure, the pressure being ramped up to the full treatment pressure while the patient is asleep.

63. The method of claim 59, wherein the breathable gas is provided at a pressure lower than the limited pressure, the pressure being ramped up to the limited pressure during the predetermined settling time, and wherein after the predetermined settling time, the breathable gas is provided at a pressure lower than the full treatment pressure, the pressure being ramped up to the full treatment pressure while the patient is asleep.

64. The method of claim 59, wherein the settling time is 1 hour.

65. The method of claim 61, further comprising specifying an amount of time in which the pressure is ramped up to the full treatment pressure.

66. The method of claim 63, further comprising specifying an amount of time in which the pressure is ramped up to the full treatment pressure.

67. The method of claim 59, further comprising:

providing a plurality of treatment sessions; and

,

increasing the limited pressure provided during the settling time in successive treatment sessions.

68. The method of claim 59, further comprising:

providing a plurality of treatment sessions; and

,

reducing the settling time in successive treatment sessions.

69. The method of claim 68, further comprising reducing the settling time in successive treatment sessions.

70. The method of claim 60, further comprising extending the settling time a predetermined amount of time based on a patient-initiated signal.

71. The method of claim 70, wherein the settling time is extended 30 minutes.

72. The method of claim 70, further comprising:

storing a number of times the patient extends the settling time; and

,

adjusting the settling time for future treatment sessions based on the number of times the patient extends the settling time.

86. The system of claim 70, further comprising:

a storage medium storing a number of times the patient extends the settling time;

wherein the flow generator is operable to adjust the settling time for future treatment sessions based on the number of times the patient extends the settling time stored in the storage medium.

73. A system for acclimatizing a patient to therapy for treatment of sleep-disordered breathing, comprising:

a flow generator operable to provide a supply of pressurized breathable gas to the patient for a predetermined settling time at a limited pressure and operable to provide the breathable gas at a full treatment pressure after the predetermined settling time;

wherein the limited pressure is lower than the full treatment pressure.

74. The system of claim 73, wherein the predetermined settling time corresponds to an amount of time it takes the patient to fall asleep.

75. The system of claim 73, wherein the flow generator is configured to provide the breathable gas at a pressure lower than the limited pressure, and further configured to ramp up to the limited pressure during the predetermined settling time.

76. The system of claim 73, wherein after the predetermined settling time, the flow generator is configured to provide the breathable gas at a pressure lower than the full treatment pressure, and further configured to ramp up to the full treatment pressure while the patient is asleep.

77. The system of claim 73, wherein the flow generator is configured to provide the breathable gas at a pressure lower than the limited pressure, and to ramp up to the limited pressure during the predetermined settling time, and further configured to provide the breathable gas at a pressure lower than the full treatment pressure, and to ramp up to the full treatment pressure while the patient is asleep.

78. The system of claim 73, wherein the settling time is 1 hour.

79. The system of claim 76, wherein the flow generator is configured to accept user input, the user input specifying an amount of time in which the pressure is ramped up to the full treatment pressure.

80. The system of claim 77, wherein the flow generator is configured to accept user input, the user input specifying an amount of time in which the pressure is ramped up to the full treatment pressure.

81. The system of claim 73, wherein the therapy is provided over a plurality of treatment sessions, and wherein the flow generator is configured to increase the limited pressure provided during the settling time in successive treatment sessions.

82. The system of claim 73, wherein the therapy is provided over a plurality of treatment sessions, and wherein the flow generator is configured to reduce the settling time in successive treatment sessions.

83. The system of claim 82, wherein the flow generator is configured to reduce the settling time in successive treatment sessions.

84. The system of claim 83, further comprising a mechanism for extending the settling time a predetermined amount of time based on a patient-initiated signal.

85. The system of claim 84, wherein the settling time is extended 30 minutes.

87. A method of acclimatizing a patient to therapy for treatment of sleep-disordered breathing, the method comprising:

treating the patient using a PAP device;

compiling patient compliance data during the treatment;

processing the patient compliance data to identify problems associated with the treatment; and

,

comparing any identified problems to a solutions database.

88. The method of claim 87, further comprising generating a recommendation as to how to alleviate any identified problems.

89. The method of claim 88, further comprising displaying the recommendation to the patient.

90. The method of claim 88, further comprising advising the patient to visit a sleep lab when a solution to an identified problem cannot be generated.

91. The method of claim 87, wherein the patient compliance data comprises changes in AHI, changes in leak level, and/or a number of mask-off events.

92. A system for acclimatizing a patient to therapy for treatment of sleep-disordered breathing, comprising:

a PAP device operable to provide a supply of pressurized breathable gas to the patient; and

,

a computer-mediated compliance monitoring package operable to execute the following steps of;

compiling patient compliance data during the treatment;

processing the patient compliance data to identify problems associated with the treatment; and

,

comparing any identified problems to a solutions database.

93. The system of claim 92, wherein the compliance monitoring package is further operable to generate a recommendation as to how to alleviate any identified problems.

94. The system of claim 93, wherein the compliance monitoring package is further operable to display the recommendation to the patient.

95. The system of claim 93, wherein the compliance monitoring package is further operable to advise the patient to visit a sleep lab when a solution to an identified problem cannot be generated.

96. The system of claim 92, wherein the patient compliance data comprises changes in AHI, changes in leak level, and/or a number of mask-off events.