Method and apparatus for impedance detecting and treating obstructive airway disorders

• US 5,540,732 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: Testerman, Roy L.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/310,120
• Time in Patent Office: 678 Days
• Field of Search: 607/42, 607/46, 607/48, 128/716
• US Class Current: 607/42
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

A method for treating upper respiratory obstructions in a patient by electrical stimulation of muscles of the upper airway including surgically implanting a impedance sensing circuit into the patient such that the impedance sensor is capable of providing a signal characteristic of transthoracic impedance in the patient. The implanted impedance sensing circuit allows the inspiratory phase of the patient'"'"'s respiratory cycle to be identified and electrical stimulation to be reliably applied during the inspiration phase.

Claims

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

(a) surgically implanting a pulse generator into the patient together with an impedance sensing circuit in a common case with the pulse generator;

(b) surgically implanting a stimulation lead extending from the pulse generator to a nerve which activates at least one of the patient'"'"'s upper airway muscles and at least two impedance measuring electrodes, at least one of said electrodes along said lead, said electrodes in electrical connection with the impedance sensing circuit such that the circuit provides a signal characteristic of thoracic impedance in the patient;

(c) monitoring the impedance signal of the implanted impedance sensing circuit for at least one parameter characteristic of onset of inspiration of the patient;

(d) detecting the onset of inspiration from the monitored parameter; and

(e) applying the electrical stimulation synchronous with the onset of inspiration, the electrical stimulation applied at a level which restores patency in the airway.

2. The method of claim 1 wherein the step of monitoring the impedance signal includes the step of monitoring a slope of the impedance signal and the step of detecting the onset of inspiration includes the step of detecting a change in the monitored slope.

3. The method of claim 2 wherein the step of monitoring the slope includes the step of monitoring the slope over an interval of about 40 to 100 ms.

4. The method of claim 1 wherein the step of monitoring the impedance signal includes the step of monitoring an amplitude of the impedance signal and the step of detecting the onset of inspiration includes the step of detecting a threshold value for the amplitude of the impedance signal.

5. The method of claim 4 wherein the threshold value is determined by the steps of:

(a) determining a baseline average value for the amplitude of the monitored signal;

(b) determining a threshold value as a function of the baseline average value.

6. The method of claim 1 wherein the Step of surgically implanting a stimulation lead in electrical connection with an impedance sensing circuit such that the circuit provides a signal characteristic of thoracic impedance in the patient includes the step of digitizing the signal and the step of monitoring the impedance signal includes the step of monitoring the digital signal.

7. A medical device for treating upper airway obstruction in a patient by electrical stimulation of muscles of the upper airway comprising:

(a) an implantable pulse generator;

(b) an impedance sensing circuit in a common case with the pulse generator;

(c) a stimulation lead adapted to extend from the pulse generator to a nerve which activates at least one of the patient'"'"'s upper airway muscles;

(d) at least two impedance measuring electrodes, at least one of said electrodes along said stimulation lead, said electrodes in electrical connection with the impedance sensing circuit such that the sensing circuit provides a signal characteristic of thoracic impedance in the patient;

(e) means responsive to said impedance sensing circuit for monitoring the impedance signal of the implanted impedance sensing circuit for at least one parameter characteristic of the onset of inspiration of the patient;

(f) means associated with said monitoring means for detecting the onset of inspiration; and

(g) means responsive to said detecting means for applying the electrical stimulation synchronous with the onset of inspiration, the electrical stimulation applied at a level which restores patency in the airway.

8. The device of claim 7 wherein said monitoring means includes slope measuring means for measuring a slope of the impedance signal and said means associated with said monitoring means for detecting the onset of inspiration includes means responsive to said slope measuring means for detecting a change in the measured slope.

9. The device of claim 8 wherein the slope measuring means includes timing means and means for measuring the slope over an interval of about 40 to 100 ms.

10. The device of claim 7 wherein said detecting means includes threshold means responsive to said monitoring means for setting a threshold value for the onset of inspiration.

11. The device of claim 10 wherein the threshold means comprises:

(a) means responsive to said monitoring means for determining a baseline average value for the monitored signal;

(b) means responsive to said baseline determining means for determining the threshold value as a function of the baseline average value.

12. The device of claim 7 wherein the impedance sensing circuit also includes means for digitizing the impedance signal and the means for monitoring the impedance signal includes means for monitoring a digitized impedance signal.