Methods and devices for treatment of obstructive sleep apnea

• US 9,144,511 B2
• Filed: 03/04/2013
• Issued: 09/29/2015
• Est. Priority Date: 08/14/2008
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Rousseau, Robert A., Weadock, Kevin S.
• Primary Examiner(s): Hicks, Victoria J
• Assistant Examiner(s): PATEL, TARLA R
• Application Number:
  US13/784,077
• Publication Number:
  US 20130174857A1
• Time in Patent Office: 939 Days
• Field of Search: 128/846, 128/848, 128859-862, 602/902, 623/9, 623/11.11, 623/14.11
• US Class Current: 1/1
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

A pharyngeal retractor device and implantation methods are provided for use in the treatment of obstructive sleep apnea. The device includes a retracting element and a tissue engaging element that promotes tissue ingrowth around or onto the retracting element. The device is implanted in tissue space beneath the pharyngeal wall to alter the shape of the wall. The device may be implanted through the oral cavity alone or by using a trocar or a hand-held delivery system to deliver the device through the pharyngeal wall. Alternatively, the device may be implanted using an open, direct visualization approach from the side of a patient'"'"'s neck.

Claims

1. A method for surgically treating obstructive sleep apnea, the method comprising the steps of:

delivering an implantable device having first and second ends into tissue located beneath a pharyngeal wall, including introducing the implantable device orally and through the pharyngeal wall into the tissue beneath the pharyngeal wall, further including;

positioning a distal end of a trocar proximate the pharyngeal wall, wherein the implantable device is covered by a protective sheath, the protective sheath having a trocar sleeve at one end and wherein the trocar sleeve covers the distal end of the trocar;

inserting the distal end of the trocar at a first location in the pharyngeal wall;

passing the implantable device through the tissue beneath the pharyngeal wall;

further advancing the trocar to exit the pharyngeal wall through a second location; and

removing the protective sheath from the implantable device by pulling the trocar sleeve until the sheath exits the pharyngeal wall.

2. The method of claim 1, further comprising the step of:

making one or more incisions in the pharyngeal wall.

3. The method of claim 1, further comprising the step of:

changing a radius of curvature of a portion of the pharyngeal wall.

4. The method of claim 1, further comprising the step of:

inducing tissue ingrowth into the implantable device.

5. The method of claim 1, wherein the implantable device is a mesh.

6. The method of claim 1, wherein the trocar has a sharpened distal end.

7. A method for surgically treating obstructive sleep apnea, the method comprising steps of:

delivering a retractor having first and second ends into tissue located beneath a pharyngeal wall, including introducing the retractor orally and through the pharyngeal wall into the tissue beneath the pharyngeal wall, further including;

creating an a medial incision in the lateral aspect of the pharyngeal wall;

positioning the first end of the retractor in and through the medial incision;

positioning the second end of the retractor in and through the medial incision;

advancing the first end of the retractor in a first lateral orientation through the tissue beneath the pharyngeal wall; and

advancing the second end of the retractor in a second lateral orientation through the tissue beneath the pharyngeal wall;

wherein the steps of advancing the retractor'"'"'s first and second ends places tension on the pharyngeal wall thereby retracting the pharyngeal wall.

8. The method of claim 7, wherein the first end of the retractor is further advanced through the skin of the neck.

9. The method of claim 8, wherein the second end of the retractor is further advanced through the skin of the neck.

10. The method of claim 8 or 9, wherein the ends of the retractor outside of the skin of the neck are trimmed.

11. The method of claim 10, where in the trimmed ends of the retractor are allowed to retract slightly to remain in a sub-dermal position.

12. The method of claim 7, wherein the retractor includes tissue engaging features.

13. The method of claim 12, wherein the tissue engaging feature is a directional frictional feature.

14. The method of claim 13, wherein the directional frictional feature is a barb.

15. The method of claim 12, wherein the retractor is a monofilament barb.

16. The method of claim 12, wherein the retractor is a braided textile structure with frictional elements encased in the braid.

17. The method of claim 12, wherein the retractor is a textile or filaments with a roughened surface.

18. The method of claim 12, wherein the retractor is a textile or filaments with a high-friction surface.

19. The method of claim 12, wherein the tissue engaging feature is a non-directional feature.

20. The method of claim 19, wherein the non-directional frictional feature is a textile.

21. The method of claim 7, wherein the retractor includes a protective sheath.

22. The method of claim 7, wherein the retractor'"'"'s ends further comprise needles.

23. The method of claim 7, wherein the first end and the second end of the retractor are advanced on the same side of a line whose orientation is anterior-posterior to the pharyngeal wall and center to the lateral aspects of the pharyngeal wall.

24. The method of claim 7, wherein the first end of the retractor is advanced at least partially in a posterior orientation and second end of the retractor is advanced at least partially in an anterior orientation and wherein the first end and the second end are advanced on the same side of a line whose orientation is anterior-posterior to the pharyngeal wall and center to the lateral aspects of the pharyngeal wall.