Feedback system and method for sleep disordered breathing therapy

• US 7,469,697 B2
• Filed: 06/09/2004
• Issued: 12/30/2008
• Est. Priority Date: 09/18/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stahmann, Jeffrey E., Hartley, Jesse W., Lee, Kent, Ni, Quan
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US10/864,287
• Publication Number:
  US 20050061315A1
• Time in Patent Office: 1,665 Days
• Field of Search: 128/204.23, 128/204.19, 128/204.18, 128/204.21, 128/200.24, 607/9, 607/14, 607/17, 607/18, 600/513, 600/533, 600/534, 600/536, 600/538
• US Class Current: 128/200.24
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity

Abstract

Methods and systems involve monitoring one or more patient conditions using a monitoring device that is fully or partially implantable. Feedback information is developed based on the monitored conditions and is provided to a device delivering therapy to treat sleep disordered breathing. Components of the monitoring device are disposed within an implantable housing that is separate from the housing of the therapy device. The therapy device may comprise a housing that is implantable or patient-external. The feedback information may be used to adjust the sleep disordered breathing therapy.

Claims

1. A method of controlling sleep disordered breathing therapy, comprising:

monitoring one or more patient conditions using a monitoring device having circuitry disposed within an implantable housing;

developing feedback information for controlling sleep disordered breathing therapy based on the one or more monitored conditions, the feedback information comprising compliance information based on a comparison of therapy usage to a prescribed therapy; and

providing the feedback information to a device delivering therapy to treat sleep disordered breathing;

adjusting the therapy to treat sleep disordered breathing based on the compliance information, wherein a housing of the therapy device is separate from the implantable housing of the monitoring device.

2. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring physiological conditions.

3. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring respiratory system conditions.

4. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring respiration patterns.

5. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring cardiovascular system conditions.

6. The method of claim 1, wherein monitoring the one or more conditions comprises monitoring cardiopulmonary conditions.

7. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring heart rate.

8. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring nervous system conditions.

9. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring blood chemistry conditions.

10. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring blood pressure conditions.

11. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring non-physiological conditions.

12. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring contextual conditions.

13. The method of claim 1, wherein monitoring the one or more patient conditions comprises monitoring environmental conditions.

14. The method of claim 1, wherein monitoring the one or more patient conditions comprises storing information associated with the one or more patient conditions.

15. The method of claim 1, wherein developing the feedback information comprises:

detecting sleep based on the one or more monitored conditions; and

developing the feedback information based on the detection of sleep.

16. The method of claim 1, wherein developing the feedback information comprises:

detecting therapy interactions based on the one or more monitored conditions; and

developing the feedback information based on the detected therapy interactions.

17. The method of claim 1, wherein developing the feedback information comprises:

determining therapy effectiveness based on the one or more monitored conditions; and

developing the feedback information based on the therapy effectiveness.

18. The method of claim 1, wherein developing the feedback information comprises:

determining an impact of the therapy on the patient based on the one or more monitored conditions; and

developing the feedback information based on the therapy impact.

19. The method of claim 1, wherein:

monitoring the one or more patient conditions comprises;

detecting sleep disordered breathing events based on the one or more patient conditions; and

determining one or more characteristics of the sleep disordered breathing events; and

developing the feedback information comprises developing the feedback information based on the one or more characteristics of the sleep disordered breathing events.

20. The method of claim 19, wherein determining the one or more characteristics of the sleep disordered breathing events comprises determining a severity of the sleep disordered breathing events.

21. The method of claim 19, wherein determining the one or more characteristics of the sleep disordered breathing events comprises determining a frequency of the sleep disordered breathing events.

22. The method of claim 19, wherein determining the one or more characteristics of the sleep disordered breathing events comprises determining a duration of the sleep disordered breathing events.

23. The method of claim 19, wherein determining the one or more characteristics of the sleep disordered breathing events comprises calculating a disordered breathing index.

24. The method of claim 19, wherein determining the one or more characteristics of the sleep disordered breathing events comprises calculating an apnea/hypopnea index.

25. The method of claim 1, wherein developing the feedback information comprises:

determining trends of the one or more monitored conditions; and

developing the feedback information based on the trends.

26. The method of claim 1, further comprising transmitting information associated with the one or more monitored conditions from the monitoring device to a separate medical device other than the therapy device, wherein developing the feedback information based on the one or more monitored conditions comprises developing the feedback information using the separate medical device.

27. The method of claim 26, wherein providing the feedback information comprises transmitting the feedback information from the separate medical device to the therapy device.

28. The method of claim 27, wherein at least one of transmitting information associated with the one or more monitored conditions from the monitoring device to the separate medical device and transmitting the feedback information from the separate medical device to the therapy device is performed wirelessly.

29. The method of claim 1, wherein:

developing the feedback information comprises developing the feedback information using the monitoring device; and

providing the feedback information to the therapy device comprises transmitting the feedback information from the monitoring device to the therapy device.

30. The method of claim 29, wherein transmitting the feedback information from the monitoring device to the therapy device comprises wirelessly transmitting the feedback information.

31. A method, comprising:

monitoring one or more patient conditions using a monitoring device having circuitry disposed within an implantable housing;

developing feedback information for controlling sleep disordered breathing therapy based on the one or more monitored conditions, the feedback information comprising compliance information based on a comparison of therapy usage to a prescribed therapy;

providing the feedback information to a device delivering therapy to treat sleep disordered breathing, wherein a housing of the therapy device is separate from the implantable housing of the monitoring device; and

adjusting the sleep disordered breathing therapy using the feedback information.

32. The method of claim 31, wherein:

providing the feedback information to the device delivering therapy to treat the sleep disordered breathing comprises providing the feedback information to a nerve stimulation device delivering nerve stimulation therapy to treat the sleep disordered breathing; and

adjusting the sleep disordered breathing therapy using the feedback information comprises adjusting the nerve stimulation therapy.

33. The method of claim 31, wherein:

providing the feedback information to the device delivering therapy to treat the sleep disordered breathing comprises providing the feedback information to a muscle stimulation device delivering muscle stimulation therapy to treat the sleep disordered breathing; and

adjusting the sleep disordered breathing therapy using the feedback information comprises adjusting the muscle stimulation therapy.

34. The method of claim 31, wherein:

providing the feedback information to the device delivering therapy to treat the sleep disordered breathing comprises providing the feedback information to a drug delivery device delivering drug therapy to treat the sleep disordered breathing; and

adjusting the sleep disordered breathing therapy using the feedback information comprises adjusting the drug therapy.

35. The method of claim 31, wherein:

providing the feedback information to the device delivering therapy to treat the sleep disordered breathing comprises providing the feedback information to a respiratory therapy device delivering a patient-external respiration therapy to treat the sleep disordered breathing; and

adjusting the sleep disordered breathing therapy using the feedback information comprises adjusting the patient-external respiration therapy.

36. The method of claim 31, wherein:

providing the feedback information to the device delivering therapy to treat the sleep disordered breathing comprises providing the feedback information to a cardiac device delivering cardiac stimulation therapy to treat the sleep disordered breathing; and

adjusting the sleep disordered breathing therapy using the feedback information comprises adjusting the cardiac stimulation therapy.

37. The method of claim 31, wherein adjusting the sleep disordered breathing therapy comprises manually adjusting the sleep disordered breathing therapy.

38. The method of claim 31, wherein adjusting the sleep disordered breathing therapy comprises automatically adjusting the sleep disordered breathing therapy.

39. A medical system, comprising:

a monitoring unit having components disposed within an implantable housing, the monitoring unit configured to monitor one or more patient conditions;

a processor coupled to the monitoring unit and configured to provide feedback information to a therapy device related to sleep disordered breathing therapy delivered to a patient based on the one or more monitored conditions, the feedback information comprising compliance information based on a comparison of therapy usage to a prescribed therapy, wherein components of the therapy device delivering the disordered breathing therapy are disposed within a therapy device housing and the therapy device housing is separate from the implantable housing of the monitoring device.

40. The medical system of claim 39, wherein the monitoring unit is configured to monitor a physiological condition.

41. The medical device of claim 39, wherein the monitoring unit is configured to monitor a respiratory system condition.

42. The medical device of claim 39, wherein the monitoring unit is configured to monitor respiration patterns.

43. The medical device of claim 39, wherein the monitoring unit is configured to monitor a cardiovascular system condition.

44. The medical device of claim 39, wherein the monitoring unit is configured to monitor a cardiopulmonary condition.

45. The medical device of claim 39, wherein the monitoring unit is configured to monitor heart rate.

46. The medical device of claim 39, wherein the monitoring unit is configured to monitor a nervous system condition.

47. The medical device of claim 39, wherein the monitoring unit is configured to monitor a blood chemistry condition.

48. The medical device of claim 39, wherein the monitoring unit is configured to monitor blood pressure.

49. The medical device of claim 39, wherein the monitoring unit is configured to monitor a non-physiological condition.

50. The medical device of claim 39, wherein the monitoring unit is configured to monitor a contextual condition.

51. The medical device of claim 39, wherein the monitoring unit is configured to monitor a patient external environmental condition.

52. The medical device of claim 39, wherein the monitoring unit further comprises a memory configured to store information associated with the one or more patient conditions.

53. The medical device of claim 39, wherein the monitoring unit further comprises a sleep detector, the sleep detector configured to detect sleep based on the one or more monitored conditions and the processor is configured to develop the feedback information based on the detection of sleep.

54. The medical device of claim 39, wherein the monitoring unit is configured to detect therapy interactions based on the one or more monitored conditions and the processor is configured to develop the feedback information based on the detected therapy interactions.

55. The medical device of claim 39, wherein the monitoring unit is configured to determine therapy effectiveness based on the one or more monitored conditions and the processor is configured to develop the feedback information based on the therapy effectiveness.

56. The medical device of claim 39, wherein the monitoring unit is configured to determine an impact of the therapy on the patient based on the one or more monitored conditions and the processor is configured to develop the feedback information based on the therapy impact.

57. The medical device of claim 39, wherein the monitoring unit further comprises a disordered breathing detector configured to detect disordered breathing events based on the one or more patient conditions and to determine one or more characteristics of the disordered breathing events and the processor is configured to develop the feedback information based on the one or more characteristics of the disordered breathing events.

58. The medical device of claim 57, wherein the disordered breathing detector is configured to determine a severity of the disordered breathing events.

59. The medical device of claim 57, wherein the disordered breathing detector is configured to determine a frequency of the disordered breathing events.

60. The medical device of claim 57, wherein the disordered breathing detector is configured to determine a duration of the disordered breathing events.

61. The medical device of claim 39, wherein the monitoring unit is configured to calculate an apnea/hypopnea index and the processor is configured to develop the feedback information based on the apnea/hypopnea index.

62. The medical device of claim 39, wherein the monitoring unit is configured to determine trends of the one or more monitored conditions and the processor is configured to develop the feedback information based on the trends.

63. A medical system, comprising:

a monitoring unit having components disposed within an implantable housing, the monitoring unit configured to monitor one or more patient conditions;

a therapy device having components disposed within a housing that is separate from the implantable housing of the monitoring device, the therapy device configured to deliver sleep disordered breathing therapy; and

a processor coupled to the monitoring unit and the therapy device, the processor configured to provide feedback information to the therapy device related to the sleep disordered breathing therapy based on the one or more patient conditions, the feedback information comprising compliance information based on a comparison of therapy usage to a prescribed therapy, wherein the sleep disordered breathing therapy delivered by the therapy device is adjusted based on the compliance information.

64. The medical system of claim 63, further comprising a transmitter configured to transmit the feedback information from the processor to the therapy device.

65. The medical system of claim 63 wherein the processor is disposed within the implantable housing of the monitoring device.

66. The medical system of claim 63, wherein the therapy device is configured to use the feedback information to adjust the sleep disordered breathing therapy.

67. The medical system of claim 63, wherein the therapy device comprises a nerve stimulation device.

68. The medical system of claim 63, wherein the therapy device comprises a muscle stimulation device.

69. The medical system of claim 63, wherein the therapy device comprises a drug therapy device.

70. The medical system of claim 63, wherein the therapy device comprises a patient-external breathing therapy device.

71. The medical system of claim 63, wherein the therapy device comprises a cardiac stimulation device.

72. A system for controlling sleep disordered breathing therapy, comprising:

means for monitoring one or more patient conditions using a monitoring device having circuitry disposed within an implantable housing;

means for developing feedback information for controlling sleep disordered breathing therapy based on the one or more monitored conditions; and

means for providing the feedback information to a device delivering therapy to treat sleep disordered breathing and adjusting the therapy based on the feedback information, the feedback information comprising compliance information based on a comparison of therapy usage to a prescribed therapy, wherein a housing of the therapy device is separate from the implantable housing of the monitoring device.

73. The system of claim 72, further comprising:

means for detecting sleep disordered breathing events based on the one or more patient conditions;

means for determining one or more characteristics of the sleep disordered breathing events; and

means for developing the feedback information based on the one or more characteristics of the sleep disordered breathing events.

74. The system of claim 73, further comprising:

means for determining a severity of the sleep disordered breathing events; and

means for developing feedback information based on the severity of the sleep disordered breathing events.

75. A medical system, comprising:

means for monitoring one or more patient conditions using a monitoring device having circuitry disposed within an implantable housing;

means for developing feedback information for controlling sleep disordered breathing therapy based on the one or more monitored conditions, the feedback information comprising compliance information based on a comparison of therapy usage to a prescribed therapy;

means for providing the feedback information to a device delivering therapy to treat sleep disordered breathing, wherein a housing of the therapy device is separate from the implantable housing of the monitoring device; and

means for adjusting the sleep disordered breathing therapy using the feedback information.