Muscle stimulating device and method for diagnosing and treating a breathing disorder

• US 6,770,022 B2
• Filed: 01/17/2001
• Issued: 08/03/2004
• Est. Priority Date: 10/17/1997
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Koninklijke Philips N.V.)
• Original Assignee: Respironics Incorporated (Koninklijke Philips N.V.), Penn State Research Foundation (Pennsylvania State University)
• Inventors: Mechlenburg, Douglas M., Gaumond, Roger Paul
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US09/761,788
• Publication Number:
  US 20010018547A1
• Time in Patent Office: 1,294 Days
• Field of Search: 128/848, 128/897-898, 128/903, 600/9-15, 600/26, 600/529-543, 607/1-3, 607/39-76, 607/33, 607/50-51, 607/61
• US Class Current: 600/9
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

A device and method for magnetic stimulation of muscles for the diagnosis and relief of a breathing disorder, such as obstructive sleep apnea is disclosed. Magnetic stimulation is used to stimulate muscles which serve to stabilize the upper airway of an individual whose nocturnal apneic events are related to diminished muscle tone. A sensor monitors a physiologic characteristic of the patient, a coil is energized to stimulate the appropriate muscles associated with the upper airway, a power supply provides power for energizing the coil, and a control system controls the application of power to the coil based on the output of the sensor. Diagnosis of obstructive sleep apnea is accomplished by measuring the subject'"'"'s compliance in the presence and absence of the magnetic stimulation of the upper airway muscles. The smaller the difference between these two compliance levels, the more likely that patient suffers from obstructive sleep apnea.

Claims

1. A muscle stimulator adapted to treat a breathing disorder, said muscle stimulator comprising:

a plurality of loops of electrical wire;

a power supply that selectively provides electrical power to said plurality of loops to produce a magnetic field;

a control unit that controls application of said electrical power from said power supply to said plurality of loops of electrical wire;

a selectively attachable collar adapted to be worn by a patient such that said plurality of loops are positioned proximate to a neck of such a patient between a chin and a sternum and relative to at least one muscle group associated with a patient'"'"'s upper airway; and

an implantable, leadless, stimulation element adapted to be located within such a patient at a location where applying an electrical stimulation to such a patient serves to stabilize an upper airway of such a patient without assistance of an implanted device that mechanically suspends tissues associated with the upper airway, and wherein said stimulation element is adapted to enhance excitability of a nerve or muscle tissue proximate to said stimulation element responsive to a wireless application of said magnetic field on said stimulation element.

2. The muscle stimulator of claim 1, wherein said stimulation element is a miniature intramuscular stimulator that is adapted to transfer energy contained in said magnetic field into electrical energy that is adapted to be applied directly to such a patient at a site of said intramuscular stimulator.

3. The muscle stimulator of claim 2, wherein said intramuscular stimulator includes:

a receiving coil adapted to receive signals from said coil;

a decoding network that enables said control unit to distinguish and control said intramuscular stimulator independently of other intramuscular stimulators; and

an electrode for applying electrical energy to a portion of a patient contacting said electrode, said electrical energy being derived from said magnetic field applied to said intramuscular stimulator.

4. The muscle stimulator of claim 2, further comprising a first intramuscular stimulator and a second intramuscular stimulator, wherein said control unit is capable of actuating said first intramuscular stimulator independent of said second intramuscular stimulator.

5. A method of applying a magnetic field to a patient to treat a breathing disorder, comprising:

affixing a plurality of loops of electrical wire proximate to said at least one muscle group associated with an upper airway of a patient;

providing electrical power to said plurality of loops of electrical wire to produce said magnetic field; and

providing an implanted, leadless stimulation element proximate to a nerve or muscle tissue in a patient at a location in such a patient where applying an electrical stimulation to such a patient serves to stabilize an upper airway of such a patient without assistance of an implanted device that mechanically suspends tissues associated with the upper airway, and wherein said stimulation element enhances excitability of such a nerve or muscle tissue responsive to a wireless application of said magnetic field on said stimulation element.

6. The method according to claim 5, wherein said stimulation element is a miniature intramuscular stimulator that is adapted to transfer energy contained in said magnetic field into electrical energy that is adapted to be applied directly to such a patient at a site of said intramuscular stimulator.

7. A method of treating obstructive sleep apnea comprising:

implanting a leadless microstimulator into target tissue within such a patient, wherein said target tissue corresponds to a location in such a patient where applying an electrical stimulation to such a patient serves to stabilize an upper airway of such a patient without assistance of an implanted device that mechanically suspends tissues associated with the upper airway;

energizing said microstimulator by providing an energizing signal to said microstimulator element; and

controlling delivery of said energizing signal to said microstimulator via an external controller located outside such a patient.

8. The method according to claim 7, wherein said target tissue includes 1) muscle tissue associated with an upper airway of such a patient or 2) nerves associated with said muscle tissue.

9. The method according to claim 7, further comprising a sensor adapted to be located relative to such a patient so as to detect an apneic event of such a patient, and wherein said controlling step includes providing said energizing signal based on detection of said apneic event.

10. The method according to claim 7, further comprising a sensor adapted to be located relative to such a patient so as to detect a respiratory pattern of such a patient, and wherein said controlling step includes providing said energizing signal based on detection an output of said sensor.

11. The method according to claim 7, wherein said implanting step includes implanting at least two leadless microstimulators in such a patient, and wherein controlling delivery of said energizing signal includes controlling actuation of said at least two microstimulators independently.

12. A system for treating obstructive sleep apnea comprising:

a first leadless microstimulator adapted to be positioned within target tissue of a patient, wherein said target tissue corresponds to a location in such a patient where applying an electrical stimulation to such a patient serves to stabilize an upper airway of such a patient without assistance of an implanted device that mechanically suspends of tissues associated with the upper airway; and

an external controller adapted to produce an energizing signal for delivery to said microstimulator.

13. The system according to claim 12, wherein said target tissue includes 1) muscle tissue associated with an upper airway of such a patient or 2) nerves associated with said muscle tissue.

14. The system according to claim 12, further comprising a sensor adapted to be located relative to such a patient so as to detect an apneic event of such a patient, and wherein said controller provides said energizing signal to said microstimulator based on detection of said apneic event.

15. The system according to claim 12, further comprising a sensor adapted to be located relative to such a patient so as to detect a respiratory pattern of such a patient, and wherein said controller provides said energizing signal to said microstimulator based on an output of said sensor.

16. The system according to claim 12, further comprising a second leadless microstimulator adapted to positioned within target tissue of a patient, wherein said target tissue corresponds to a location in such a patient where applying an electrical stimulation to such a patient serves to stabilize an upper airway of such a patient, and wherein said controller controls delivery of said energizing signal to said first microstimulator and said second microstimulator independently.