Method and apparatus for synchronized treatment of obstructive sleep apnea

• US 6,251,126 B1
• Filed: 10/04/1999
• Issued: 06/26/2001
• Est. Priority Date: 04/23/1998
• Status: Expired due to Term

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Michels, Koen J., Ottenhoff, Frans A. M.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/411,845
• Time in Patent Office: 631 Days
• Field of Search: 607/42, 607/72, 607/44
• US Class Current: 607/42
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601

Abstract

A method and apparatus for synchronized treatment of obstructive sleep apnea. In one embodiment such stimulation is provided by an implantable pulse generator, the implantable pulse generator having a stimulation stage to output stimulation pulses to a body structure, a sensing stage to sense the respiratory effort of a patient, and a controller, to coordinate, and preferably to synchronize, the output stimulation pulses with the sensed respiratory effort. The respiratory effort of a patient is sensed through the use of two electrodes disposed such that the diaphragm is positioned between, and the high frequency current is injected from one electrode to the other and the corresponding impedance is measured, the corresponding impedance thus being a function of the diaphragm position, itself indicating the respiratory effort of the patient. In such a manner the present invention permits the delivery of stimulation to be precisely controlled by the actual respiratory effort of the patient.

Claims

1. An implantable pulse generator for treating obstructive sleep apnea in a patient, comprising:

means for determining when the patient has entered a sleep state;

means for electrically stimulating a nerve in the upper airway tract of the patient to elicit a contraction by an innervated muscle, the means for electrically stimulating being operative for a pre-determined period of time after the sleep state determining means determines the patient has entered the sleep state;

means for sensing the respiratory effort of a patient comprising first and second electrodes suitable for placement on opposite sides of the patient'"'"'s diaphragm, the respiratory effort sensing means delivering high frequency current between the electrodes to thereby measure the impedance therebetween; and

a controller to control the means for electrically stimulating in coordination with the sensed respiratory effort.

2. The implantable pulse generator according to claim 1 wherein the means for electrically stimulating a nerve in the upper airway tract comprises means for delivery electrical stimulation pulse trains.

3. The implantable pulse generator according to claim 2 means for delivery electrical stimulation pulse trains comprises means for delivery the electrical stimulation pulse trains to a nerve.

4. The implantable pulse generator according to claim 3 wherein the controller controls the means for electrically stimulating in synchrony with the sensed respiratory effort of a patient such that the means for electrically stimulating is activated only upon a sensed respiratory effort of a patient.

5. The implantable pulse generator according to claim 1 wherein the means for sensing the respiratory effort of a patient comprise a first electrode adapted to be positioned adjacent the diaphragm and a second electrode adapted to be positioned adjacent the diaphragm and opposite the first electrode, such that the diaphragm can be disposed between the first and second electrodes.

6. The implantable pulse generator according to claim 5 further comprising means for and sensing the impedance between the first electrode and the second electrode.

7. The implantable pulse generator according to claim 6 wherein the means for and sensing the impedance between the first electrode and the second electrode further comprises means for injecting a high frequency current between the first electrode and the second electrode.

8. The implantable pulse generator according to claim 7 wherein the means for injecting a high frequency current between the first electrode and the second electrode comprises means for injecting an alternating current having an amplitude of approximately 1 mAmp and a frequency between approximately 4 kHz-64 kHz.

9. The implantable pulse generator according to claim 1 wherein the controller controls the means for electrically stimulating in synchrony with the sensed respiratory effort of a patient.

10. A method of treating obstructive sleep apnea in a patient, comprising the steps of:

determining when the patient has entered a sleep state;

sensing respiratory effort of the patient using first and second electrodes disposed on opposite sides of the patient'"'"'s diaphragm, the first and second electrodes delivering high frequency current thereacross to permit measurement of the impedance therebetween as a measure of the sensed respiratory effort; and

continuously stimulating a hypoglossal nerve of the patient for a pre-determined period of time after the sleep state has been entered, the stimulation being provided in coordination with the sensed respiratory effort.

11. The method of claim 10 wherein the step of sensing the respiratory effort further comprises injecting high frequency current across the diaphragm and sensing the resulting impedance.

12. The method of claim 11 wherein the step of injecting high frequency current across the diaphragm comprises injecting an alternating current having an amplitude of approximately 1 mAmp and a frequency between approximately 4 kHz-64 kHz.

13. The method of claim 10 wherein the step of stimulating the hypoglossal nerve comprises delivering electrical stimulation pulse train to the hypoglossal nerve.

14. The method of claim 13 wherein the step of delivering electrical stimulation pulse train to the hypoglossal nerve comprises delivering a series of at least two pulse to the hypoglossal nerve.

15. The method of claim 14 wherein the step of delivering electrical stimulation pulse train to the hypoglossal nerve comprises delivering a series of at least two pulse monophasic pulses to the hypoglossal nerve.

16. The method of claim 15 wherein the step of delivering electrical stimulation pulse train to the hypoglossal nerve comprises delivering a series of at least two pulse having an amplitude of between approximately 1-50 milliamps and pulse width between approximately 3-1000 microseconds.