Method and apparatus for pressure detecting and treating obstructive airway disorders

• US 5,540,731 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:
  US08/310,177
• Time in Patent Office: 678 Days
• Field of Search: 128/716, 607/42, 607/46, 607/48
• US Class Current: 607/42
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• 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 pressure sensor into the patient such that the pressure sensor is capable of providing a signal characteristic of intrathoracic pressure in the patient. The implanted pressure sensor 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 an implantable pulse generator into the patient;

(b) surgically implanting a pressure sensor in a body structure which has pressure coupling with an intrapleural space of the patient and which is in communication with the pulse generator such that the pressure sensor provides to the pulse generator a signal characteristic of intrathoracic pressure in the patient;

(c) monitoring the pressure signal of the implanted pressure sensor 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 pressure signal includes the step of monitoring a slope of the pressure 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 pressure signal includes the step of monitoring an amplitude of the pressure signal and the step of detecting the onset of inspiration includes the step of detecting the monitored amplitude above a threshold value for the amplitude.

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 pressure sensor such that the pressure sensor provides a signal characteristic of intrathoracic pressure in the patient includes the step of digitizing the pressure signal and the step of monitoring the pressure signal includes the step of monitoring the digital signal.

7. The method of claim 1 wherein the step of surgically implanting a pressure sensor includes the step of implanting the pressure sensor subcutaneously at the patient'"'"'s suprasternal notch.

8. The method of claim 1 wherein the step of surgically implanting a pressure sensor includes the step of implanting the pressure sensor between the patient'"'"'s trachea and esophagus at a flexible posterior wall of the trachea.

9. 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) a hermetically sealed, implantable pressure sensor for providing a signal characteristic of intrathoracic pressure in the patient;

(c) means associated with said pressure sensor for communicating the intrathoracic pressure signal to the pulse generator;

(d) means for monitoring the pressure signal of the implanted pressure sensor for at least one parameter characteristic of the onset of inspiration of the patient;

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

(f) means associated with 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.

10. The device of claim 9 wherein said monitoring means includes slope measuring means for measuring a slope of the pressure signal and wherein 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.

11. The device of claim 10 wherein the slope measuring means includes timing means and means responsive to said timing means for measuring the slope over an interval of about 40 to 100 ms.

12. The device of claim 9 wherein said detecting means includes threshold means associated with said monitoring means and said stimulation means for setting a threshold value for the onset of inspiration.

13. The device of claim 12 wherein the threshold means comprises:

(a) means associated with said monitoring means for determining a baseline average value for the monitored signal;

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

14. The device of claim 9 wherein the means for monitoring the pressure signal includes means for digitizing the pressure signal and also means for monitoring a digitized impedance signal.