Devices and methods for sleep apnea treatment

• US 9,205,262 B2
• Filed: 10/02/2012
• Issued: 12/08/2015
• Est. Priority Date: 05/12/2011
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Bolea, Stephen, Tesfayesus, Wondimeneh, Beck, John, Hoegh, Thomas, Atkinson, Robert, Hauschild, Sidney
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin
• Application Number:
  US13/633,670
• Publication Number:
  US 20130085546A1
• Time in Patent Office: 1,162 Days
• Field of Search: 607/42
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601

Abstract

Devices and methods for improving the coupling between the soft palate and the genioglossus. This may be accomplished, for example, but shortening or stiffening the palatoglossal arch. Improved coupling between the soft palate and the genioglossus may be beneficial to a patient suffering from obstructive sleep apnea (OSA) as a stand-alone procedure, or in combination procedures and devices that cause anterior displacement of the tongue such as hypoglossal nerve stimulation, genioglossus advancement surgery, mandibular advancement surgery, mandibular advancement (oral) appliances, etc.

Claims

1. A method of treating an upper airway tissue collapse condition of a patient, comprising:

Implanting at least one tissue engagement member in the patient'"'"'s upper airway tissue to improve a coupling between the patient'"'"'s genioglossus muscle and a portion of the patient'"'"'s upper airway tissue; and

providing a stimulation therapy that delivers an electrical stimulation to a hypoglossal nerve of the patient to cause an advancement of the patient'"'"'s genioglossus muscle and/or an anterior movement of the patient'"'"'s tongue, the stimulation therapy having an efficacy in the treatment of the upper airway tissue collapse condition, wherein the at least one tissue engagement member improves the efficacy of the stimulation therapy.

2. A method as in claim 1, wherein improving the coupling between the patient'"'"'s genioglossus muscle and the portion of the patient'"'"'s upper airway tissue includes tightening the patient'"'"'s pharyngeal tissue.

3. A method as in claim 2, wherein tightening the patient'"'"'s pharyngeal tissue includes shortening the patient'"'"'s palatoglossus.

4. A method as in claim 2, wherein tightening the patient'"'"'s pharyngeal tissue includes shortening the patient'"'"'s palatopharyngeus.

5. A method as in claim 2, wherein tightening the patient'"'"'s pharyngeal tissue includes shortening the patient'"'"'s pharyngoepiglottic fold.

6. A method as in claim 1, wherein the stimulation therapy causes genioglossus contraction.

7. The method as in claim 1, wherein the upper airway tissue collapse condition is an obstructive sleep apnea condition of the patient, and wherein the efficacy of the stimulation therapy mitigates the obstructive sleep apnea condition.

8. The method as in claim 1, wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient'"'"'s upper airway and a second tissue collapse at a second location within the patient'"'"'s upper airway, wherein the efficacy of the stimulation therapy corresponds to a mitigation of the first tissue collapse at the first location, and wherein the improvement of the efficacy of the stimulation therapy corresponds to a mitigation of the second tissue collapse at the second location.

9. A method of treating an upper airway tissue collapse condition of a patient, comprising:

modifying a first length of the patient'"'"'s palatoglossus to a shortened second length by implanting at least one tissue engagement member in a first portion of tissue disposed at the patient'"'"'s palatoglossus to improve a coupling between a movement of the patient'"'"'s tongue and a corresponding movement of a second portion of tissue disposed in the couplings upper airway;

disposing a stimulation device configured to electrically stimulate the patient to move the patient'"'"'s tongue anteriorly, the patient'"'"'s tongue being coupled to the second portion of tissue via the first portion of tissue; and

maintaining the corresponding movement of the second portion of tissue when delivering an electrical stimulation.

10. A method as in claim 9, wherein disposing the stimulation device includes implanting the stimulation device, and delivering the electrical stimulation to includes electrically stimulating a nerve innervating an upper airway muscle of the patient.

11. A method as in claim 10, wherein the nerve includes a hypoglossal nerve.

12. A method as in claim 9, further comprising causing the patient'"'"'s tongue to move anteriorly by performing a genioglossus advancement surgical procedure.

13. A method as in claim 9, further comprising causing the patient'"'"'s tongue to move anteriorly by implanting a device in communication with the tongue.

14. A method as in claim 9, further comprising causing the patient'"'"'s tongue to move anteriorly by performing a mandibular advancement surgical procedure.

15. A method as in claim 9, further comprising causing the patient'"'"'s tongue to move anteriorly by using an oral appliance.

16. A method as in claim 15, wherein the oral appliance is a mandibular advancement device.

17. The method as in claim 9, wherein the upper airway tissue collapse condition is an obstructive sleep apnea condition of the patient, and wherein electrically stimulating the patient to move the patient'"'"'s tongue mitigates the obstructive sleep apnea condition.

18. The method as in claim 9, wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient'"'"'s upper airway and a second tissue collapse at a second location within the patient'"'"'s upper airway, wherein electrically stimulating the patient to move the patient'"'"'s tongue corresponds to a mitigation of the first tissue collapse at the first location, and wherein the modifying of the patient'"'"'s palatoglossus corresponds to a mitigation of the second tissue collapse at the second location.

19. A method as in claim 9, wherein modifying the first length of the patient'"'"'s palatoglossuss to the shortened second length includes a surgical shortening of the patient'"'"'s palatoglossus.

20. A method of treating an upper airway tissue collapse condition of a patient, comprising:

Implanting at least one tissue engagement member in the patient'"'"'s upper airway tissue to tighten the patient'"'"'s upper airway from a first condition of the patient'"'"'s upper airway tissue to a second condition of the patient'"'"'s upper airway tissue that has a greater stiffness than the first condition. the patient'"'"'s upper airway issue in the second condition conveying anterior movement of the patient'"'"'s tongue to maintain a patency of the patient'"'"'s upper airway; and

disposing a stimulation device configured for delivering an electrical stimulation to a nerve innervating a tongue protruder muscle of the patient to cause an anterior movement of the patient'"'"'s tongue, wherein the at least one tissue engagement member improves an efficacy of the electrical stimulation.

21. A method as in claim 20, wherein tightening the patient'"'"'s upper airway tissue includes tightening the patient'"'"'s pharyngeal tissue.

22. A method as in claim 21, wherein tightening the patient'"'"'s pharyngeal tissue includes shortening one of the patient'"'"'s palatoglossus, palatopharyngeus, and pharyngoepiglottic fold.

23. The method as in claim 20, wherein the upper airway tissue collapse condition is an obstructive sleep apnea condition of the patient, and wherein the delivering of the electrical stimulation mitigates the obstructive sleep apnea condition.

24. The method as in claim 20, wherein the upper airway tissue collapse condition includes a first tissue collapse at a first location within the patient'"'"'s upper airway and a second tissue collapse at a second location within the patient'"'"'s upper airway, wherein the delivering of the electrical stimulation corresponds to a mitigation of the first tissue collapse at the first location, and wherein the tightening of the patient'"'"'s upper airway tissue corresponds to a mitigation of the second tissue collapse at the second location.

25. A method of treating an upper airway condition of a patient, the method comprising:

implanting a first device in the upper airway of the patient, the first device having a first end secured to a first portion of upper airway tissue coupled to the tongue of the patient and an opposing second end secured to a second portion of upper airway tissue coupled to at least one of the patient'"'"'s soft palate, palatopharyngeus, and palatoglossus; and

implanting a second device in the patient, the second device disposed to deliver an electrical stimulation signal to the patient'"'"'s hypoglossal nerve to move the second portion of upper airway tissue via the first device.

26. A method of treating an upper airway condition of a patient, the method comprising:

implanting first and second devices in the patient'"'"'s neck to treat a collapsed portion of the patient'"'"'s upper airway, the second device being a stimulation delivery device disposed and configured to deliver an electrical stimulation signal to cause a movement of the patient'"'"'s tongue, the first device disposed and configured to convey the stimulated movement of the patient'"'"'s tongue to the collapsed portion of the patient'"'"'s upper airway, wherein to open the collapsed portion of the patient'"'"'s upper airway; and

maintaining the delivery of the stimulation signal during an inspiration cycle of the patient.