Method and apparatus for treating obstructive sleep apnea (OSA)

• US 10,314,736 B2
• Filed: 10/16/2013
• Issued: 06/11/2019
• Est. Priority Date: 10/16/2012
• Status: Active Grant

• Current Assignee: C2Dx, Inc.
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Catalano, Peter J.
• Primary Examiner(s): Hicks, Victoria J
• Assistant Examiner(s): Lee, Michelle J
• Application Number:
  US14/055,159
• Publication Number:
  US 20140102460A1
• Time in Patent Office: 2,064 Days
• Field of Search: 128848, 606191
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

A method for treating obstructive sleep apnea is described herein. The method includes the step of providing a tethering device having an elastic filament having a distal end and a proximal end and a flexible memory head mounted to the distal end of the elastic filament. The method further includes the steps of advancing the tethering device through the tongue of a patient so that the flexible memory head of the tethering device is disposed against the back of the tongue and the elastic filament of the tethering device extends through the tongue and securing the proximal end of the elastic filament to the mandible of the patient under tension, whereby to restrain rearward movement of the tongue while the patient is sleeping.

Claims

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

providing a tethering device comprising;

an elastic filament having a terminal distal end and a proximal end; and

a flexible memory head directly mounted to the terminal distal end of the elastic filament and having a proximal side and a distal side, the flexible memory head comprising a disk structure comprising soft, pliable atraumatic material, the flexible memory head comprising a patterned recess formed in the proximal side of the flexible memory head and a like-patterned head stiffener received in the patterned recess;

advancing the tethering device through the tongue of a patient so that the flexible memory head of the tethering device exits a back of the tongue and is disposed against an external surface of the back of the tongue and the elastic filament of the tethering device extends from the flexible memory head and through the tongue; and

securing the proximal end of the elastic filament to the mandible of the patient under tension, whereby to restrain rearward movement of the tongue while the patient is sleeping;

wherein the elastic filament extends from the terminal distal end and away from the distal side of the flexible memory head.

2. A method according to claim 1 further comprising the step of mounting the proximal end of the elastic filament to a bone anchor.

3. A method according to claim 2 wherein the proximal end of the elastic filament comprises a plurality of enlargements;

and

wherein the plurality of enlargements is used to secure the proximal end of the elastic filament to the bone anchor.

4. A method according to claim 3 wherein the bone anchor comprises a mount having a hole and a slot formed therein;

and

wherein the plurality of enlargements is sized to pass through the hole but is prevented from passing through the slot.

5. A method according to claim 1 wherein the tethering device is advanced through the tongue of the patient using a corridor sheath having a lumen extending therethrough, a corridor trocar, an outer inserter tube having a lumen extending therethrough, and an inner inserter tube having a lumen extending therethrough, wherein the corridor trocar is sized to fit within the lumen of the corridor sheath, the outer inserter tube is sized to fit within the lumen of the corridor sheath, the inner inserter tube is sized to fit within the lumen of the outer inserter tube, and the lumen of the inner inserter tube is sized to receive the elastic filament therethrough.

6. A method according to claim 5 wherein the corridor trocar comprises a light source.

7. A method according to claim 1 wherein the head stiffener comprises a superelastic material.

8. A method according to claim 7 wherein the head stiffener comprises Nitinol.

9. A method according to claim 1 wherein the flexible memory head comprises a multi-lobe structure comprising the soft, pliable atraumatic material.

10. A method according to claim 9 wherein the recess of the flexible memory head comprises a multi-lobe recess and the head stiffener of the flexible memory head comprises a multi-lobe head stiffener.

11. A method according to claim 1 wherein the proximal end of the elastic filament comprises a plurality of enlargements.

12. A method according to claim 11 wherein each enlargement of the plurality of enlargements is frustoconical in configuration.

13. A method according to claim 1 wherein the flexible memory head comprises an elastic filament recess formed in the proximal side of the flexible memory head;

and

wherein the terminal distal end of the elastic filament is disposed within the elastic filament recess.

14. A method according to claim 13 wherein the patterned recess is separate from and surrounds the elastic filament recess.

15. A method according to claim 1 wherein the elastic filament is secured to the head stiffener.

16. A method according to claim 1 wherein the head stiffener comprises a multi-lobe configuration.

17. A method according to claim 1 wherein the disk structure comprises a plurality of holes for passing air therethrough.

18. A method for treating obstructive sleep apnea, the method comprising:

providing a tethering device comprising;

an elastic filament having a terminal distal end and a proximal end; and

a flexible memory head directly mounted to the terminal distal end of the elastic filament and having a proximal side and a distal side, the flexible memory head comprising a patterned recess formed in the proximal side of the flexible memory head and a like-patterned head stiffener received in the patterned recess;

advancing the tethering device through the tongue of a patient so that the flexible memory head of the tethering device exits a back of the tongue and is disposed against an external surface of the back of the tongue and the elastic filament of the tethering device extends from the flexible memory head and through the tongue; and

securing the proximal end of the elastic filament to the mandible of the patient under tension, whereby to restrain rearward movement of the tongue while the patient is sleeping;

wherein the elastic filament extends from the terminal distal end and away from the distal side of the flexible memory head.

19. A method for treating obstructive sleep apnea, the method comprising:

providing a tethering device comprising;

an elastic filament having a terminal distal end and a proximal end; and

a flexible memory head directly mounted to the terminal distal end of the elastic filament and having a proximal side and a distal side, the flexible memory head comprising a disk structure comprising soft, pliable atraumatic material, the flexible memory head comprising a patterned recess formed in the proximal side of the flexible memory head and a like-patterned head stiffener received in the patterned recess, the flexible memory head comprising a multi-lobe configuration, the head stiffener comprising a superelastic material;

advancing the tethering device through the tongue of a patient using a corridor sheath having a lumen extending therethrough so that the flexible memory head of the tethering device exits a back of the tongue and is disposed against an external surface of the back of the tongue and the elastic filament of the tethering device extends from the flexible memory head and through the tongue; and

securing the proximal end of the elastic filament to the mandible of the patient under tension, whereby to restrain rearward movement of the tongue while the patient is sleeping;

wherein the tethering device is advanced through the tongue of the patient using the corridor sheath, a corridor trocar, and outer inserter tube having a lumen extending therethrough, and an inner inserter tube having a lumen extending therethrough;

wherein the corridor trocar is sized to fit within the lumen of the corridor sheath, the outer inserter tube is sized to fit within the lumen of the corridor sheath, the inner inserter tube is sized to fit within the lumen of the outer inserter tube, and the lumen of the inner inserter tube is sized to receive the elastic filament therethrough; and

wherein the corridor trocar comprises a light source; and

wherein the elastic filament extends from the terminal distal end and away from the distal side of the flexible memory head.