Method and apparatus for synchronized treatment of obstructive sleep apnea

• US 6,269,269 B1
• Filed: 10/04/1999
• Issued: 07/31/2001
• 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:
  US09/411,844
• Time in Patent Office: 666 Days
• Field of Search: 607/42, 607/72
• 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. A system 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 through the provision of electrical stimuli thereto, the electrical stimulating means being operably connected to the sleep state determining means and being operative continuously over a pre-determined period of time after the sleep state determining means has determined the patient has entered the sleep state;

means for sensing the respiratory effort of a patient operably connected to the electrical stimulating means and 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;

wherein the electrical stimulating means provides electrical stimuli to the innervated muscle in coordination with the sensed respiratory effort of the patient.

2. The implantable pulse generator according to claim 1, further comprising means for delaying the activation of the means for sensing and the means for electrically stimulating.

3. The implantable pulse generator according to claim 1, wherein the means for stimulating having means for deactivating the delivery of electrical stimulating based on the sensed effort.

4. The implantable pulse generator according to claim 3, wherein the means for delivery electrical stimulation pulse trains comprise means for delivering at least one monophasic pulse.

5. The implantable pulse generator according to claim 4, wherein the means for delivery electrical stimulation pulse trains comprise means for delivering a series of monophasic pulses.

6. The implantable pulse generator according to claim 4, wherein the at least one monophasic pulse has an amplitude between approximately 1 and 7 Volts.

7. The implantable pulse generator according to claim 4, wherein the means for delivery electrical stimulation pulse trains comprise a series of at least two pulses.

8. The implantable pulse generator according to claim 7, wherein the at least two pulses have an amplitude of between approximately 1-50 milliamps and pulse width between approximately 3-1000 microseconds.

9. The implantable pulse generator according to claim 8, wherein the pulse train delivered at a rate of between approximately 7-27 bpm.