Method and apparatus for detecting and treating obstructive sleep apnea

• US 5,540,733 A
• Filed: 09/21/1994
• Issued: 07/30/1996
• Est. Priority Date: 09/21/1994
• Status: Expired due to Term

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bierbaum, Ralph W., Testerman, Roy L., Erickson, Donald J.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/310,140
• Time in Patent Office: 678 Days
• Field of Search: 607/42, 128/716, 128/721, 128/782, 128/725
• US Class Current: 607/42
• CPC Class Codes: A61B 5/1135 by monitoring thoracic expansion
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

A method for treating obstructive sleep apnea in a patient by electrical stimulation of muscles of the upper airway includes detecting an obstructive apnea and then stimulating muscles of the upper airway in response to the apnea. The apnea is detected by monitoring changes in a respiratory effort waveform of the patient for a parameter characteristic of the patient'"'"'s level of respiratory effort which is averaged over successive respiratory cycles to provide a baseline average. A limit value is then generated from the baseline average and the value for the parameter is compared with the limit value. If the limit value is exceeded, an apnea event is detected. Electrical stimulation can then be applied to a muscle of the upper airway upon detection of the apnea at a level which restores patency to the airway.

Claims

1. A method for treating obstructive sleep apnea in a patient by electrical stimulation of muscles of the upper airway by the steps of:

(a) detecting an apnea by the steps of;

(1) monitoring a respiratory effort waveform for a parameter characteristic of the patient'"'"'s level of respiratory effort;

(2) averaging a plurality of values of the parameter taken from successive respiratory cycle, said average providing a baseline average for the parameter;

(3) generating a limit value from the baseline average;

(4) comparing a value of the parameter with the limit value; and

(b) applying electrical stimulation to the muscles of the upper airway upon detection of the apnea at a level which restores patency in the airway

wherein the parameter is a peak amplitude of the waveform.

2. The method of claim 1 wherein the peak amplitude of the waveform is the difference in amplitude between an inspiratory peak and an expiratory peak of the waveform in a respiratory cycle.

3. A method for treating obstructive sleep apnea in a patient by electrical stimulation of muscles of the upper airway by the steps of:

(a) detecting an apnea by the steps of;

(1) monitoring a respiratory effort waveform for a parameter characteristic of the patient'"'"'s level of respiratory effort;

(2) averaging a plurality of values of the parameter taken from successive respiratory cycles, said average providing a baseline average for the parameter;

(3) generating a limit value from the baseline average;

(4) comparing a value of the parameter with the limit value; and

(b) applying electrical stimulation to the muscles of the upper airway upon detection of the apnea at a level which restores patency in the airway

wherein the baseline average value is generated as an exponential moving average value.

4. A method for treating obstructive sleep apnea in a patient by electrical stimulation of muscles of the upper airway by the steps of:

(a) detecting an apnea by the steps of;

(1) monitoring a respiratory effort waveform for a parameter characteristic of the patient'"'"'s level of respiratory effort;

(2) averaging a plurality of values of the parameter taken from successive respiratory cycles, said average providing a baseline average for the parameter;

(3) generating a limit value from the baseline average;

(4) comparing a value of the parameter with the limit value; and

(b) applying electrical stimulation to the muscles of the upper airway upon detection of the apnea at a level which restores patency in the airway

wherein the limit value is in the range of about 115% to 150% of the baseline average.

5. A method for treating obstructive sleep apnea in a patient by electrical stimulation of muscles of the upper airway by the steps of:

(a) detecting an apnea by the steps of;

(1) monitoring a respiratory effort waveform for a parameter characteristic of the patient'"'"'s level of respiratory effort;

(2) averaging a plurality of values of the parameter taken from successive respiratory cycles, said average providing a baseline average for the parameter;

(3) generating a limit value from the baseline average;

(4) comparing a value of the parameter with the limit value; and

(b) applying electrical stimulation to the muscles of the upper airway upon detection of the apnea at a level which restores patency in the airway

wherein detection of apnea requires an increase in the value of the parameter for each of two to five successive respiratory cycles.

6. A medical device for treating obstructive sleep apnea in a patient by electrical stimulation of muscles of the upper airway comprising:

(a) apnea detection means for detecting an apnea, said means comprising;

(1) monitoring means for monitoring a respiratory effort waveform for a parameter characteristic of the patient'"'"'s level of respiratory effort;

(2) averaging means associated with said monitoring means for averaging a plurality of values of the parameter taken from successive respiratory cycles, said average providing a baseline average for the parameter;

(3) limit generating means associated with said averaging means for generating a limit value from the baseline average;

(4) comparison means associated with said monitoring means and said limit generating means for comparing a value of the parameter with the limit value; and

(b) applying electrical stimulation to the muscles of the upper airway upon detection of the apnea at a level which restores patency in the airway

wherein the parameter is a peak amplitude of the waveform.

7. The medical device of claim 6 wherein the peak amplitude of the waveform is the difference in amplitude between an inspiratory peak and an expiratory peak of the waveform in a respiratory cycle.

8. A medical device for treating obstructive sleep apnea in a patient by electrical stimulation of muscles of the upper airway comprising:

(a) apnea detection means for detecting an apnea, said means comprising;

(1) monitoring means for monitoring a respiratory effort waveform for a parameter characteristic of the patient'"'"'s level of respiratory effort;

(2) averaging means associated with said monitoring means for averaging a plurality of values of the parameter taken from successive respiratory cycles, said average providing a baseline average for the parameter;

(3) limit generating means associated with said averaging means for generating a limit value from the baseline average;

(4) comparison means associated with said monitoring means and said limit generating means for comparing a value of the parameter with the limit value; and

(b) stimulation means associated with said apnea detection means for applying electrical stimulation to the muscles of the upper airway upon detection of the apnea at a level which restores patency in the airway

wherein the average value is generated as an exponential moving average value.

9. A medical device for treating obstructive sleep apnea in a patient by electrical stimulation of muscles of the upper airway comprising:

(a) apnea detection means for detecting an apnea, said means comprising;

(1) monitoring means for monitoring a respiratory effort waveform for a parameter characteristic of the patient'"'"'s level of respiratory effort;

(2) averaging means associated with said monitoring means for averaging a plurality of values of the parameter taken from successive respiratory cycles, said average providing a baseline average for the parameter;

(3) limit generating means associated with said averaging means for generating a limit value from the baseline average;

(4) comparison means associated with said monitoring means and said limit generating means for comparing a value of the parameter with the limit value; and

(b) stimulation means associated with said apnea detection means for applying electrical stimulation to the muscles of the upper airway upon detection of the apnea at a level which restores patency in the airway

wherein the limit value is in the range of about 115% to 150% of the baseline average.

10. A medical device for treating obstructive sleep apnea in a patient by electrical stimulation of muscles of the upper airway comprising:

(a) apnea detection means for detecting an apnea, said means comprising;

(1) monitoring means for monitoring a respiratory effort waveform for a parameter characteristic of the patient'"'"'s level of respiratory effort;

(2) averaging means associated with said monitoring means for averaging a plurality of values of the parameter taken from successive respiratory cycles, said average providing a baseline average for the parameter;

(3) limit generating means associated with said averaging means for generating a limit value from the baseline average;

(4) comparison means associated with said monitoring means and said limit generating means for comparing a value of the parameter with the limit value; and

(b) stimulation means associated with said apnea detection means for applying electrical stimulation to the muscles of the upper airway upon detection of the apnea at a level which restores patency in the airway

wherein the means for detecting apnea also comprises means associated with said monitoring means and said averaging means for detecting an increase in values of the parameter for each of two to five successive respiratory cycles.