Method and apparatus for synchronized treatment of obstructive sleep apnea
First Claim
1. A method for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
- (a) providing a respiratory effort waveform of the patient;
(b) monitoring the respiratory effort waveform of the patient for a change in slope of the respiratory effort waveform characteristic of an inspiratory turn point and for a predetermined amplitude characteristic of an inspiratory turn point;
(c) detecting an inspiratory turn point according to the monitored first change in slope or amplitude in step (b); and
(d) commencing stimulation in response to the detected inspiratory turn point.
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Accused Products
Abstract
A method and device is provided for stimulation of an upper airway muscle of a patient to relieve an airway obstruction in which stimulation is synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle. A respiratory effort waveform of the patient is monitored for a changes in slope and amplitude of the respiratory effort waveform characteristic of the inspiratory phase. Stimulation is then commenced and concluded according to the detected inspiratory phase.
665 Citations
96 Claims
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1. A method for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient for a change in slope of the respiratory effort waveform characteristic of an inspiratory turn point and for a predetermined amplitude characteristic of an inspiratory turn point; (c) detecting an inspiratory turn point according to the monitored first change in slope or amplitude in step (b); and (d) commencing stimulation in response to the detected inspiratory turn point. - View Dependent Claims (2, 3)
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4. A method for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient for n change in slope of the respiratory effort waveform characteristic of an inspiratory turn point and for a predetermined amplitude characteristic of an inspiratory turn point; (c) detecting an inspiratory turn point according to the monitored first change in slope or amplitude in step (b); and (d) commencing stimulation in response to the detected inspiratory turn point, wherein the change in slope is determined by the steps of; (1) determining a moving average slope for the respiratory effort waveform; (2) determining a current slope for the respiratory effort waveform; and (3) comparing the current slope with the moving average slope. - View Dependent Claims (5, 6, 7, 8)
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9. A method for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient for a change in slope of the respiratory effort waveform characteristic of an inspiratory turn point and for a predetermined amplitude characteristic of an inspiratory turn point; (c) detecting an inspiratory turn point according to the monitored first change in slope or amplitude in step (b); and (d) commencing stimulation in response to the detected inspiratory turn point, wherein the predetermined amplitude characteristic of an inspiratory turn point is provided by the steps of; (1) determining an average peak-to-valley amplitude for the waveform; and (2) determining the predetermined amplitude as a function of the peak-to-valley amplitude. - View Dependent Claims (10, 11, 12)
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13. A method for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient for a change in slope of the respiratory effort waveform characteristic of an inspiratory turn point and for a predetermined amplitude characteristic of an inspiratory turn point; (c) detecting an inspiratory turn point according to the monitored first change in slope or amplitude in step (b); and (d) commencing stimulation in response to the detected inspiratory turn point, wherein the stimulation is commenced during a next respiratory cycle following detection of the inspiratory turn point by the steps of; (1) determining a representative respiratory cycle time for the patient; (2) determining when the inspiratory turn point is detected; (3) determining a time for commencement of stimulation as a function of the respiratory cycle time and when the inspiratory turn point is detected. - View Dependent Claims (14)
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15. A method for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a signal characteristic of respiratory effort of the patient; (b) sampling the signal at a predetermined interval to provide a digitized respiratory effort waveform; (c) determining a moving average slope for the respiratory effort waveform; (d) determining a current slope for the respiratory effort waveform; (e) comparing the current slope with the moving average slope to detect the inspiratory phase; and (f) commencing and concluding stimulation of the upper airway muscle according to the detected inspiratory phase. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A method for controlling stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient for a change characteristic of an inspiratory turn point; (c) commencing stimulation in response a detected inspiratory turn point; (d) monitoring elapsed time since detection of the inspiratory turn point; (e) monitoring the respiratory effort waveform for an inspiratory peak; (f) concluding stimulation upon the earlier of (1) detection of the inspiratory peak or (2) elapse of a predetermined period of time, wherein the step of monitoring the respiratory effort waveform for a change characteristic of an inspiratory turn point includes the steps of; (1) determining a moving average slope for the respiratory effort waveform; (2) determining a current slope for the respiratory effort waveform; and (3) comparing the current slope with the moving average slope. - View Dependent Claims (27, 28, 29, 30)
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31. A method for controlling stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient for a change characteristic of an inspiratory turn point; (c) commencing stimulation in response a detected inspiratory turn point; (d) monitoring elapsed time since detection of the inspiratory turn point; (e) monitoring the respiratory effort waveform for an inspiratory peak; (f) concluding stimulation upon the earlier of (1) detection of the inspiratory peak or (2) elapse of a predetermined period of time, wherein the stimulation is commenced during a next respiratory cycle following detection of the inspiratory turn point by the steps of; (1) determining a representative respiratory cycle time for the patient; (2) determining when the inspiratory turn point is detected; (3) determining a time for commencement of stimulation as a function of the respiratory cycle time and when the inspiratory turn point is detected.
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32. A method for controlling stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient for a change characteristic of an inspiratory turn point; (c) commencing stimulation in response a detected inspiratory turn point; (d) monitoring elapsed time since detection of the inspiratory turn point; (e) monitoring the respiratory effort waveform for an inspiratory peak; (f) concluding stimulation upon the earlier of (1) detection of the inspiratory peak or (2) elapse of a predetermined period of time, wherein the inspiratory peak is determined by; (1) identifying when the moving average slope first becomes negative; (2) timing out a predetermined interval; and (3) determining whether the moving average slope is negative as the predetermined interval is concluded. - View Dependent Claims (33)
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34. A method for controlling stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient for a change characteristic of an inspiratory point; (c) commencing stimulation in response a detected inspiratory turn point; (d) monitoring elapsed time since detection of the inspiratory turn point; (e) monitoring the respiratory effort waveform for an inspiratory peak; (f) concluding stimulation upon the earlier of (1) detection of the inspiratory peak or (2) elapse of a predetermined period of time, wherein the predetermined period of time is in a range of about 1.5 to 3.5 seconds.
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35. A method for controlling stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient; (c) detecting a change in the respiratory effort waveform characteristic of an inspiratory turn point; (d) commencing stimulation in response to the detected inspiratory turn point; (e) monitoring the respiratory effort waveform for an artifact not characteristic of normal respiratory activity; and (f) suppressing stimulation upon detection of the artifact. - View Dependent Claims (36, 37, 38, 39, 40)
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41. A method for controlling stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a respiratory effort waveform of the patient; (b) monitoring the respiratory effort waveform of the patient; (c) detecting a change in the respiratory effort waveform characteristic of an inspiratory turn point; (d) commencing stimulation in response to the detected inspiratory turn point; (e) monitoring the respiratory effort waveform for an artifact not characteristic of normal respiratory activity; (f) detecting an artifact in the waveform; and (g) suppressing stimulation upon detection of the artifact, wherein the inspiratory turn point is detected by the steps of; (1) determining a moving average slope for the respiratory effort waveform; (2) determining a current slope for the respiratory effort waveform; and (3) comparing the current slope with the moving average slope. - View Dependent Claims (42, 43, 44, 45)
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46. A method for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a signal characteristic of respiratory effort of the patient; (b) sampling the signal at a predetermined interval to provide a digitized respiratory effort waveform; (c) determining a moving average slope for the respiratory effort waveform; (d) determining a current slope for the respiratory effort waveform; (e) comparing the current slope with the moving average slope to determine an inspiratory turn point by a current slope that is in a range of about 1.5 to 5 times the moving average slope; and (f) commencing stimulation of the upper airway muscle according to the detected inspiratory turn point. - View Dependent Claims (47, 48, 49, 50, 51, 52)
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53. A method for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, the method comprising the steps of:
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(a) providing a signal characteristic of respiratory effort of the patient; (b) sampling the sensed signal at a predetermined interval to provide a digitized respiratory effort waveform; (c) determining highest and lowest amplitude values of the digitized waveform for a plurality of successive respiratory cycles; (d) determining a difference between highest and lowest amplitude values for each of the plurality of respiratory cycles; (e) determining an average of the plurality of amplitude value differences; (f) monitoring the respiratory effort waveform; (g) determining an amplitude trigger value as a function of the average amplitude difference; (h) detecting an inspiratory turn point by attainment of the amplitude trigger value in the monitored respiratory waveform; and (i) commencing stimulation in response to the detected inspiratory turn point. - View Dependent Claims (54, 55, 56, 57, 58, 59)
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60. A device for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, said device comprising:
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(a) slope monitoring means for monitoring a respiratory effort waveform of the patient for a change in slope of the respiratory effort waveform characteristic of an inspiratory turn point; (b) amplitude monitoring means for monitoring the respiratory effort waveform for a predetermined amplitude characteristic of an inspiratory turn point; (c) detecting means for detecting the first inspiratory turn point according to slope or amplitude criteria; and (d) stimulation means for commencing stimulation in response to the detected inspiratory turn point. - View Dependent Claims (61, 62, 63, 64, 65, 66, 67, 68)
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69. A device for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle, comprising:
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(a) sensing means for sensing a signal characteristic of respiratory effort of the patient; (b) sampling means for sampling the signal at a predetermined interval to provide a digitized respiratory effort waveform; (c) slope average determining means for determining a moving average slope for the respiratory effort waveform; (d) slope determining means for determining a current slope for the respiratory effort waveform; (e) comparison means for comparing the current slope with the moving average slope; (f) phase detecting means for detecting the inspiratory phase according to the slope comparison; and (g) stimulation means for commencing and concluding stimulation of the upper airway muscle according to the detected inspiratory phase. - View Dependent Claims (70, 71, 72, 73, 74, 75, 76)
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77. A device for controlling stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle comprising:
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(a) turn point monitoring means for monitoring a respiratory effort waveform of the patient for a change characteristic of an inspiratory turn point; (b) stimulation commencing means for commencing stimulation in response to a detected inspiratory turn point; (c) time monitoring means for monitoring elapsed time since detection of the inspiratory turn point; (d) peak monitoring means for monitoring the respiratory effort waveform for an inspiratory peak; (e) stimulation concluding means for concluding stimulation upon the earlier of (1) detection of the inspiratory peak or (2) elapse of a predetermined period of time. - View Dependent Claims (78, 79, 80, 81, 82, 83)
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84. A device for controlling stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle comprising:
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(a) waveform monitoring means for monitoring a respiratory effort waveform of the patient; (b) turn point detection means for detecting a change in the respiratory effort waveform characteristic of an inspiratory turn point; (c) stimulation commencement means for commencing stimulation in response to a detected inspiratory turn point; (d) artifact monitoring means for monitoring the respiratory effort waveform for an artifact not characteristic of normal respiratory activity; and (e) stimulation suppressing means for suppressing stimulation upon detection of the artifact. - View Dependent Claims (85, 86)
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87. A device for controlling stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle comprising:
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(a) waveform monitoring means for monitoring a respiratory effort waveform of the patient; (b) turn point detection means for detecting a change in the respiratory effort waveform characteristic of an inspiratory turn point; (c) stimulation commencement means for commencing stimulation in response to the detected inspiratory turn point; (d) artifact monitoring means for monitoring the respiratory effort waveform for an artifact not characteristic of normal respiratory activity; (e) artifact detecting means for detecting an artifact in the waveform; and (f) stimulation suppressing means for suppressing stimulation upon detection of the artifact, wherein the turn point detection means comprises; (1) average slope determining means for determining a moving average slope for the respiratory effort waveform; (2) current slope determining means for determining a current slope for the respiratory effort waveform; and (3) comparison means for comparing the current slope with the moving average slope. - View Dependent Claims (88)
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89. A device for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle comprising:
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(a) sensing means for sensing a signal characteristic of respiratory effort of the patient; (b) sampling means for sampling the signal at a predetermined interval to provide a digitized respiratory effort waveform; (c) average slope determining means for determining a moving average slope for the respiratory effort waveform; (d) current slope determining means for determining a current slope for the respiratory effort waveform; (e) turn point determining means for comparing the current slope with the moving average slope to determine an inspiratory turn point by a current slope that is in a range of about 1.5 to 5 times the moving average slope; and (g) stimulation commencement means for commencing stimulation of the upper airway muscle according to the detected inspiratory turn point. - View Dependent Claims (90, 91, 92)
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93. A device for providing stimulation of an upper airway muscle of a patient to relieve an airway obstruction, said patient having a respiratory cycle with an inspiratory phase, said stimulation synchronized with the inspiratory phase of the patient'"'"'s respiratory cycle comprising:
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(a) sensing means for sensing a signal characteristic of respiratory effort of the patient; (b) sampling means for sampling the sensed signal at a predetermined interval to provide a digitized respiratory effort waveform; (c) amplitude determining means for determining highest and lowest amplitude values of the digitized waveform for a plurality of successive respiratory cycles; (d) difference determining means for determining a difference between highest and lowest amplitude values for each of the plurality of respiratory cycles; (e) average determining means for determining an average of the plurality of amplitude value differences; (f) trigger value determining means for determining an amplitude trigger value as a function of the average amplitude difference; (g) turn point determining means for detecting an inspiratory turn point by attainment of the amplitude trigger value in the respiratory effort waveform; and (h) stimulation commencement means for commencing stimulation in response to the detected inspiratory turn point. - View Dependent Claims (94, 95, 96)
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Specification