METHODS AND DEVICES FOR THE TREATMENT OF AIRWAY OBSTRUCTION, SLEEP APNEA AND SNORING

• US 20080053461A1
• Filed: 08/08/2007
• Published: 03/06/2008
• Est. Priority Date: 02/08/2005
• Status: Active Grant

• Current Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Original Assignee: Aspire Medical Incorporated
• Inventors: Shulock, Damien, Frazier, Andrew, Jackson, Jasper, Dineen, Michael, Roue, Chad, van der Burg, Erik, Hirotsuka, Mark
• Granted Patent: US 8,371,307 B2
• Time in Patent Office: Days
• US Class Current: 128/848
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

Methods and devices for the treatment of airway obstruction, sleep apnea and snoring are disclosed. In some embodiments, a glossal suspension system includes a tissue tensioner that includes a suture loop made of one or more sutures configured to suspend the tongue with at least one portion configured to extend laterally through the tongue, and a securement mechanism configured to be attached to a patient'"'"'s mandible that includes one more adjustment assemblies for engaging the one or more sutures and adjusting tension on the suture loop. Various tethers and anchors that can be used with the glossal suspension system are also disclosed.

Claims

1. A method for treating a condition of an airway, comprising:

providing a securement mechanism configured to be attached to a patient'"'"'s mandible, the securement mechanism comprising one or more adjustment mechanisms;

passing one or more sutures through a tongue to form a suture loop, at least a portion of the suture loop passing laterally through the tongue;

securing the one or more sutures relative to the patient'"'"'s mandible with the securement mechanism, wherein the one or more sutures engage the one or more adjustment mechanisms and the securement mechanism is secured to the patient'"'"'s mandible; and

adjusting tension in the suture loop by manipulating the one or more adjustment mechanisms.

2. The method of claim 1, wherein the securement mechanism comprises a bone screw attached to the mandible.

3. The method of claim 1, wherein the suture loop comprises a first suture portion and a second suture portion both engaged with a first adjustment assembly.

4. The method of claim 1, wherein the suture loop comprises a first suture portion engaged with a first adjustment assembly and a second suture portion engaged with a second adjustment assembly.

5. The method of claim 1, wherein the one or more adjustment assemblies comprise one or more adjustment spools.

6. The method of claim 1, wherein the securement mechanism is attached to the patient'"'"'s mandible before passing one or more sutures through the tongue to form a suture loop.

7. The method of claim 1, wherein the securement mechanism is attached to the patient'"'"'s mandible before engaging the one or more sutures with the one or more adjustment mechanisms.

8. The method of claim 1, wherein the one or more sutures engage the one or more adjustment mechanisms before attaching the securement mechanism to the patient'"'"'s mandible.

9. A tissue tensioner for suspending the tongue comprising:

a suture loop comprising one or more sutures configured to suspend the tongue with at least one portion configured to extend laterally through the tongue; and

a securement mechanism configured to be attached to a patient'"'"'s mandible, the securement mechanism comprising one or more adjustment assemblies for engaging the one or more sutures and adjusting tension on the suture loop.

10. The tissue tensioner of claim 9, wherein the securement mechanism comprises a bone screw attached to the mandible.

11. The tissue tensioner of claim 9, wherein the suture loop comprises a first suture portion and a second suture portion both engaged with a single adjustment assembly.

12. The tissue tensioner of claim 9, wherein the suture loop comprises a first suture portion engaged with a first adjustment assembly and a second suture portion engaged with a second adjustment assembly.

13. The tissue tensioner of claim 9, wherein the one or more adjustment assemblies comprise one or more adjustment spools.

14. A method for treating a condition of an airway, comprising:

providing a securement mechanism configured to be attached to a patient'"'"'s mandible;

providing a plurality of elongate members, the elongate members each being connected to a tissue anchor;

attaching the plurality of tissue anchors to a tongue;

connecting the plurality of elongate members to the securement mechanism; and

securing the securement mechanism to the mandible.

15. The method of claim 14, wherein the securing of the securement mechanism to the mandible occurs before connecting the plurality of elongate members to the securement mechanism.

16. The method of claim 14, wherein the securing of the securement mechanism to the mandible occurs after connecting the plurality of elongate members to the securement mechanism.

17. The method of claim 14, wherein the securement mechanism is secured to an inferior portion of the mandible.

18. The method of claim 14, wherein the plurality of elongate members are tethers.

19. The method of claim 18, wherein the tethers are elastic tethers.

20. The method of claim 18, wherein the tethers are beaded tethers.

21. The method of claim 18, wherein the tethers are active variable length tethers.

22. The method of claim 14, wherein the elongate members have a biocompatible coating applied to at least some parts of the elongate members.

23. The method of claim 14, wherein the elongate members have a tissue ingrowth surface.

24. The method of claim 14, comprising a pair of elongate members having tissue anchors connected thereto, the tissue anchors attached to the tongue on both lateral sides of the tongue.

25. The method of claim 14, comprising securing the securement mechanism to the mandible at a midpoint thereof.

26. The method of claim 14, further comprising adjusting the tension or length of the elongate member using an adjustment assembly operably attached to the elongate member.

27. A tissue tensioner for suspending the tongue comprising:

a securement mechanism configured to be attached to a patient'"'"'s mandible; and

a plurality of elongate members, the elongate members each being connected to a tissue anchor;

wherein the tissue anchors are configured to be connected to lateral portions of the tongue and the elongate members are configured to be connected to the securement mechanism.

28. The tensioner of claim 27, wherein the securement mechanism comprises a clamping interface.

29. The tensioner of claim 27, wherein the elongate member is a tether.

30. The tensioner of claim 27, wherein the tether is an elastic tether.

31. The tensioner of claim 27, wherein the tether has a biocompatible coating applied to at least some parts of the tether.

32. The tensioner of claim 27, wherein the tether has a tissue engaging surface.

33. The tensioner of claim 27, wherein the tether is a beaded tether.

34. The tensioner of claim 27, further comprising at least one adjustment mechanism operably attached to the securement mechanism and engaged with the elongate members for adjusting tension in the elongate members.

35. A method for treating a condition of an airway comprising:

providing a tensioner comprising an elongate member and a hyoid anchor connected to the elongate member configured to engage and grip a surface of a hyoid bone;

providing a securement mechanism configured to be attached to a patient'"'"'s mandible;

engaging the hyoid bone with the hyoid anchor;

connecting the elongate member to the securement mechanism; and

securing the securement mechanism to the mandible.

36. The method of claim 35, wherein the securing of the securement mechanism to the mandible occurs before connecting the elongate member to the securement mechanism.

37. The method of claim 35, wherein the securing of the securement mechanism to the mandible occurs after connecting the elongate member to the securement mechanism.

38. The method of claim 35, wherein the elongate member is a tether.

39. The method of claim 38, wherein the tether is an elastic tether.

40. The method of claim 38, wherein the tether is an active variable length tether.

41. The method of claim 35, wherein the elongate member has a biocompatible coating applied on at least some parts of the elongate member.

42. The method of claim 35, wherein the elongate member has a tissue engaging surface.

43. The method of claim 35, wherein the securement mechanism comprises an adjustment mechanism, and further comprising adjusting tension on the elongate member between the mandible and the hyoid bone.

44. The method of claim 35, wherein the hyoid anchor comprises at least one barb for engaging an upper ridge of the hyoid bone.

45. The method of claim 35, wherein the hyoid anchor has a first relatively straightened configuration and a second relatively curved configuration, wherein engaging the hyoid bone with the hyoid anchor comprises transforming the hyoid anchor to the second relatively curved configuration.

46. A tensioner for treating a condition of an airway comprising:

an elongate member and a hyoid anchor connected to the elongate member configured to engage and grip a surface of a hyoid bone; and

a securement mechanism configured to be attached to a patient'"'"'s mandible, the securement mechanism being connectable to the elongate member.

47. The tensioner of claim 46, wherein the elongate member is a tether.

48. The tensioner of claim 47, wherein the tether is an elastic tether.

49. The tensioner of claim 47, wherein the tether has a biocompatible coating applied to at least some parts of the tether.

50. The tensioner of claim 47, wherein the tether has a tissue engaging surface.

51. The tensioner of claim 47, wherein the tether is a beaded tether.

52. The tensioner of claim 46, wherein the securement mechanism comprises an adjustment mechanism.

53. The tensioner of claim 46, wherein the hyoid anchor comprises at least one barb for engaging an upper ridge of the hyoid bone.

54. The tensioner of claim 46, wherein the hyoid anchor has a first relatively straightened configuration and a second relatively curved configuration.