OBSTRUCTIVE SLEEP APNEA TREATMENT DEVICES, SYSTEMS AND METHODS

• US 20120192874A1
• Filed: 05/12/2011
• Published: 08/02/2012
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Apnex Medical, Inc.
• Inventors: Hoegh, Thomas B., Kuhnley, Brian D., Suilmann, Dale G., Tesfayesus, Wondimeneh, Bosshard, Mark R., Atkinson, Robert E., BOLEA, Stephen L., Persson, Bruce J., Beck, John P., Hauschild, Sidney F., Skubitz, Jason J., Parrish, Daniel A.
• Granted Patent: US 9,913,982 B2
• Time in Patent Office: Days
• US Class Current: 128/848
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

Devices, systems and methods of neurostimulation for treating obstructive sleep apnea. The system is adapted to send an electrical signal from an implanted neurostimulator through a stimulation lead to a patient'"'"'s nerve at an appropriate phase of the respiratory cycle based on input from a respiration sensing lead. External components are adapted for wireless communication with the neurostimulator. The neurostimulator is adapted to deliver therapeutic stimulation based on inputs.

Claims

1. A device for stimulating a hypoglossal nerve, comprising:

a neurostimulator for generating an electrical signal and measuring a bio-impedance signal;

a stimulation lead connected to the neurostimulator, the stimulation lead having a nerve cuff electrode configured for delivering the electrical signal to the hypoglossal nerve; and

a respiration sensing lead having a proximal portion with a proximal end connected to the neurostimulator and a distal end terminating in a bifurcation with first and second distal portions extending in different directions therefrom, wherein the first and second distal portions are configured to extend over opposite sides of the thorax.

2. A device as in claim 1, wherein the first distal portion is configured to extend over the ipsi-lateral side of the thorax, and the second distal portion is configured to extend over the contra-lateral side of the thorax.

3. A device as in claim 1, wherein the first distal portion is configured to extend over the ipsi-lateral costal margin, and the second distal portion is configured to extend over the contra-lateral costal margin.

4. A device as in claim 1, wherein at least one of the first and second distal portions includes a sensing electrode, wherein the bio-impedance signal is delivered via the sensing electrode to the neurostimulator.

5. A device as in claim 1, wherein at least one of the first and second distal portions includes a current injection electrode.

6. A device as in claim 1, wherein the proximal portion and the distal portions of the respiration sensing lead comprise tubes with electrical conductors extending there-through.

7. A device as in claim 1, wherein bifurcation includes a yoke connecting the proximal portion with the distal portions of the respiration sensing lead.

8. A method of delivering therapy to a subject, comprising:

chronically implanting a neurostimulator connected to a stimulation delivery lead;

titrating a stimulation level of the neurostimulator while the subject is asleep on a first night to determine a range of effective stimulation levels, wherein the effective range has a lower bound and an upper bound, wherein the upper bound corresponds to a stimulation level that causes arousal from sleep;

delivering therapy at a first level while the subject is asleep on a second night subsequent to the first night, wherein the first level is below or within the effective range; and

delivering therapy at a second level while the subject is asleep on a third night subsequent to the second night, wherein the second level is greater than the second level and within the effective range.

9. A method as in claim 8, wherein the stimulation delivery lead is connected to a nerve innervating a muscle.

10. A method as in claim 8, wherein the stimulation delivery lead is connected to a nerve innervating an upper airway dilator muscle.

11. A method as in claim 8, wherein the stimulation delivery lead is connected to a hypoglossal nerve innervating a genioglossus muscle.

12. A method as in claim 8, wherein the third night is at least a week subsequent to the second night.

13. A method as in claim 8, wherein the therapy is used in conjunction with a tooth guard.

14. A method as in claim 8, wherein the therapy is used in conjunction with a PAP device.

15. A method as in claim 8, wherein the PAP device is auto-PAP.

16. A method as in claim 8, wherein the therapy is used in conjunction with EPAP.

17. A method of delivering therapy to a subject, comprising:

chronically implanting a neurostimulator connected to a stimulation delivery lead, the stimulation delivery lead connected to a hypoglossal nerve;

programming the neurostimulator using a programmer to enable a limited range of stimulation settings to be adjusted by the subject;

providing a therapy controller to the subject; and

adjusting the stimulation level using the therapy controller to a level within the pre-programmed range.

18-39. -39. (canceled)