SYSTEMS AND METHODS TO TREAT UPPER PHARYNGEAL AIRWAY OF OBSTRUCTIVE SLEEP APNEA PATIENTS

• US 20130319427A1
• Filed: 06/01/2012
• Published: 12/05/2013
• Est. Priority Date: 06/01/2012
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: David C. Lindh, Sr.
• Inventors: Sung, An-Amin Jason, Rousseau, Robert A., Lindh, David C. Sr.
• Granted Patent: US 9,173,766 B2
• Time in Patent Office: Days
• US Class Current: 128/848
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

Obstructive Sleep Apnea (OSA) may be caused by a collapse of the pharyngeal wall as a result of increasing negative airway pressure. This invention is directed to systems and methods to resist collapse of the pharyngeal wall by minimally invasive upper pharyngeal airway surgery.

Claims

1. A method of supporting or reshaping a targeted tissue with a device, wherein the device comprises a central load bearing section having a first end and a second end, a first filament section having a first free end and a second end connected to the first end of the load bearing section, and a second filament section having a first free end and a second end connected to the second end of the load bearing section comprising the steps of:

a) passing the free end of the first filament section in a first direction leaving the load bearing section around the targeted tissue and into a first supporting tissue;

b) passing the free end of the second filament section into tissue in a different direction from the first direction and into a second supporting tissue while maintaining the load bearing section around the targeted tissue; and

c) applying tension to the free ends of the first and second filament sections to sufficiently support or reshape the targeted tissue.

2. The method of claim 1 wherein the targeted tissue is the palatopharyngeal muscle.

3. The method of claim 1 wherein the first supporting tissue is the palatoglossal muscle and neighboring muscular structures and the second supporting tissue is the palatopharyngeal muscle and neighboring muscular structures such as the superior pharyngeal constrictor muscle.

4. The method of claim 3 wherein the applied tension to the free ends of the filaments results in the palatopharyngeal muscle being retracted toward the palatoglossal muscle.

5. The method of claim 4 wherein the first filament section contains barbs.

6. The method of claim 4 wherein the second filament section contains barbs.

7. The method of claim 5 wherein both the first and second filament sections contain barbs.

8. The method of claim 7 wherein the barbs of the first filament section are oriented in a direction opposite to the orientation of the barbs of the second filament section.

9. A method of increasing the patency of an airway of a patient comprising the step of retracting or supporting one or both of the palatopharyngeal muscles.

10. The method of claim 9 wherein the step of retracting or supporting the palatopharyngeal muscle(s) comprises:

a) piercing at least one of the palatopharyngeal muscles with a device comprising a filament extending from a tab wherein the filament end of the device pierces at least one of the palatopharyngeal muscles;

b) drawing the filament end of the device through the at least one palatopharyngeal muscle until the tab rests at the point where the palatopharyngeal muscle had been pierced; and

c) applying tension to the filament end of the device to retract or support the at least one of the palatopharyngeal muscles.

11. The method of claim 10 where the filament is barbed.

12. The method of claim 11 wherein two devices each comprising a barbed filament and tab both pierce at least one of the palatopharyngeal muscles and the filament end of one of the devices anchors in the palatoglossal muscle and the filament end of the second of the devices anchors in the palatopharyngeal muscle.

13. A tissue support or reshaping device comprising:

a) a central load bearing section having a first end and a second end;

b) a first filament section having a first end and a second end with the first end connected to the first end of the load bearing section;

c) a second filament section having a first end and a second end with the first end connected to the second end of the load bearing section; and

wherein the first filament section comprises barbs.

14. The device of claim 13 wherein the second filament section comprises barbs.

15. The device of claim 14 wherein the orientation of the barbs of first filament section is opposite of the orientation of the barbs of the second filament section.

16. The device of claim 15 wherein the second end of the first filament is tapered and the second end of the second filament is tapered.

17. The device of claim 13 wherein the second end of the first filament is tapered and the second end of the second filament is tapered.

18. A kit comprising the devices of any of the claims 13 to 17.

19. The kit of claim 18 further comprising needles.

20. The kit of claim 19 wherein the needles are attached to the devices at the tapered ends of the first filament and the second filament.

21. The kit of claim 18 further comprising a suture passer or trocar.

22. A tissue support or reshaping device comprising:

a) a low profile proximal tab having a tissue facing surface and a thickness; and

b) a filament section extending from said tissue facing surface.

23. The device of claim 22 wherein the filament section is barbed.

24. The device of claim 23 wherein the low profile tab thickness ranges from 0.005 to 0.050 inches.

25. The device of claim 24 wherein the ratio of tissue facing surface area to thickness of the tab ranges from 0.01 to 5.