Devices and methods for treating sleep disorders

• US 7,644,714 B2
• Filed: 05/23/2006
• Issued: 01/12/2010
• Est. Priority Date: 05/27/2005
• Status: Expired due to Fees

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Apnex Medical, Inc.
• Inventors: Kugler, Chad J., Atkinson, Robert E.
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): ROBINSON, JAMES MARSHALL
• Application Number:
  US11/438,330
• Publication Number:
  US 20060266369A1
• Time in Patent Office: 1,330 Days
• Field of Search: 128/848, 128/898, 128/897, 128/860, 128/899, 600/12, 600/37, 602/902, 606/60, 606/263, 606/264
• US Class Current: 128/848
• CPC Class Codes: A61C 7/06 Extra-oral force transmitting means, i.e. means worn externally of the mouth and placing a member in the mouth under tension
• CPC Class Codes: A61C 7/08 Mouthpiece-type retainers or positioners, e.g. for both the lower and upper arch arch-shaped medicament applicators for teeth or gums A61C19/063; mouthguards for protecting the teeth of sportsmen A63B71/085
• 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
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: Y10S 602/902 Antisnoring or mouth closing devices

Abstract

Devices and methods for maintaining an open airway are described. Systems and methods are described for maintaining an opening of an airway by application of force to a patient'"'"'s tissues in one of inferior, anterior, and lateral directions.

Claims

1. A medical device, comprising:

an elongate member having a first end, a second end, and a length in between the first and second ends, wherein the elongate member further includes a housing having first and second magnets movably disposed therein, a first flexible member extending from the first magnet in a direction away from the second magnet, and a second flexible member extending from the second magnet in a direction away from the first magnet, and wherein the first end includes a first anchoring structure and the second end includes a second anchoring structure, and wherein a longitudinal tensile force in the elongate member is configured to increase as the length of the elongate member decreases.

2. The medical device of claim 1, wherein the device is configured to alter the positioning of structure associated with a patient'"'"'s upper airway.

3. The medical device of claim 2, wherein the structure includes a hyoid bone of the patient.

4. The medical device of claim 2, wherein the structure includes a thyroid cartilage of the patient.

5. The medical device of claim 2, wherein altering the positioning of structure associated with a patient'"'"'s upper airway opens the patient'"'"'s upper airway.

6. The medical device of claim 2, wherein the device is configured to treat a sleep disorder.

7. The medical device of claim 1, wherein the medical device is configured to dilate a patient'"'"'s upper airway by altering the positioning of one of a patient'"'"'s hyoid bone and thyroid cartilage.

8. The medical device of claim 7, wherein dilating a patient'"'"'s upper airway includes increasing a luminal size of the patient'"'"'s upper airway.

9. The medical device of claim 1, wherein the increase in the tensile force corresponds to the decrease in length of the elongate member.

10. The medical device of claim 1, wherein the elongate member includes an expanded PTFE sheath surrounding a portion of the elongate member, the expanded PTFE sheath configured to promote tissue ingrowth.

11. A method for altering a patient'"'"'s upper airway, comprising:

providing an elongate member having a first end, a second end and a length therebetween, wherein the elongate member further includes a housing having first and second magnets movably disposed therein, a first flexible member extending from the first magnet in a direction away from the second magnet, and a second flexible member extending from the second magnet in a direction away from the first magnet;

securing the first end of the elongate member to a first anatomical structure of the patient'"'"'s upper airway; and

securing the second end of the elongate member to a second anatomical structure of the patient'"'"'s upper airway, wherein the second anatomical structure is spaced from the first anatomical structure by a first distance, and wherein a tension in the elongate member is configured to increase as the length of the elongate member decreases.

12. The method of claim 11, wherein the first end includes a first anchoring structure and the second end includes a second anchoring structure.

13. The method of claim 12, wherein one of the first and second anchoring structures is configured to penetrate tissue.

14. The method of claim 11, wherein the one of the first and second anchoring structures is configured to be embedded within tissue.

15. The method of claim 13, wherein one of the first and second anchoring structures includes an elongate member having radially extending projections.

16. The method of claim 12, wherein the second anchoring structure includes a screw, and securing the second end to the second anatomical structure includes inserting the screw into a bone.

17. The method of claim 12, wherein the first anchoring structure has a first configuration, and the second anchoring structure has a second configuration different than the first configuration.

18. The method of claim 12, wherein one of the first and second anchoring structures includes a loop.

19. The method of claim 11, wherein the method further includes adjusting a length of the elongate member.

20. The method of claim 11, wherein one of the first and second anatomical structures includes the patient'"'"'s mandible.

21. The method of claim 11, wherein the elongate member includes a flexible cable.

22. The method of claim 11, wherein the first anatomical structure is different from the second anatomical structure.

23. The method of claim 11, wherein the elongate member is configured to promote tissue ingrowth.

24. The method of claim 11, wherein the elongate member includes an expanded PTFE sheath surrounding a portion of the elongate member, the expanded PTFE sheath configured to promote tissue ingrowth.

25. The method of claim 11, wherein altering the patient'"'"'s upper airway includes increasing a luminal size of the airway.

37. The method of claim 11, wherein the method further includes providing a second elongate member and securing the second elongate member to the patient.

26. A Mthod of maintaining an open airway comprising:

providing a first tension member and a second tension member, each tension member including a first end, a second end, and a length therebetween, wherein each tension member further includes a housing having a first and second magnets movably diposed therein, a first elongate member extending from the first magnet in a direction away from the second magnet, and a second elongate member extending from the second magnet ina direction away from the first magnet;

securing a first end of each tension member to a patient'"'"'s hyoid bone; and

securing a second end of each tension member to surrounding anatomical structure such that the tension members pull the hyoid bone in anterior and inferior directions, thereby increasing a luminal size of the airway, wherein the tension in the first tension member is configured to increase as the length of the first tension member decreases, and tension in the second tension member is configured to increase as the length of the second tension member decreases.

27. The method of claim 26, wherein the second end of the first tension member is secured to the chin, and the second end of the second tension member is secured to a clavicle.

28. The method of claim 27, wherein the second end of the second tension member is secured to a right clavicle, and a third tension member is provided having a first end secured to the hyoid bone and a second end secured to a left clavicle.

29. The method of claim 26, wherein the first tension member includes an anchor mechanism at each end of the first tension member.

30. The method of claim 29, wherein the anchor mechanism includes at least one of a screw, a loop, and an anchor having an expandable portion.

31. The method of claim 26, wherein at least one of the first and second tension members pull the hyoid bone in a lateral direction.

32. The method of claim 26, wherein the second end of the first tension member is secured to the chin, and the second end of the second tension member is secured to the sternum.

33. The method of claim 26, wherein the second end of the first tension member is secured to a left lateral portion of the chin, a second end of the second tension member is secured to a right clavicle, a third tension member is provided having a first end secured to the hyoid bone and a second end secured to a left clavicle, and a fourth tension member is provided having a first end secured to the hyoid bone and a second end secured to a right lateral portion of the chin.

34. The method of claim 26, wherein the second end of the first tension member is secured to a middle portion of the chin, a second end of the second tension member is secured to a left lateral portion of the thyroid cartilage, and a third tension member is provided having a first end secured to the hyoid bone and a second end secured to a right lateral portion of the thyroid cartilage.

35. The method of claim 26, wherein securing the first and second ends of each tension member comprises creating an incision proximate an anatomical attachment point, threading the tension members through a patient'"'"'s muscle and tissue, and anchoring the first and second ends to anatomical locations.

36. The method of claim 26, further comprising adjusting the tension in at least one of the tension members.

38. A method for treating a sleep disorder, comprising:

providing a tension member having a first end, a second end, and a length in between the first and second ends, wherein the tension member further includes a housing having first and second magnets movably disposed therein, a first elongate member extending from the first magnet in a direction away from the second magnet, and a second elongate member extending from the second magnet in a direction away from the first magnet, and wherein the first end includes a first anchoring structure and the second end includes a second anchoring structure;

securing the first anchoring structure to a first anatomical structure of a patient'"'"'s upper airway; and

securing the second anchoring structure to a second anatomical structure of the patient'"'"'s upper airway, wherein securing the second anchoring structure to the second anatomical structure causes the tension member to bias one of the first and second anatomical structures towards the other of the first and second anatomical structures to dilate the patient'"'"'s upper airway, and wherein tension in the tension member is configured to increase as the length of the tension member decreases.

39. The method of claim 38, wherein the magnet pair is arranged such that north poles of each magnet in the magnet pair face each other.

40. The method of claim 38, wherein the magnet pair is arranged such that south poles of each magnet in the magnet pair face each other.

41. The method of claim 38, wherein the tension member includes an expanded PTFE sheath surrounding a portion of the tension member, the expanded PTFE sheath configured to promote tissue ingrowth.

42. The method of claim 38, wherein one of the first and second anchoring structures is configured to be embedded in tissue.

43. method of claim 38, wherein the method further includes providing a second elongate member and securing the second elongate member to the patient.

44. The method of claim 38, wherein the first anchoring structure has a first configuration, and the second anchoring structure has a second configuration different than the first configuration.

45. The method of claim 38, wherein one of the first and second anchoring structures includes a loop.

46. A method of altering a patient'"'"'s upper airway, comprising:

providing a device including an elongate member having a first end, a second end, and a length in between the first and second ends, wherein the elongate member further includes a housing having first and second magnets movably disposed therein, a first flexible member extending from the first magnet in a direction away from the second magnet, and a second flexible member extending from the second magnet in a direction away from the first magnet, and wherein a longitudinal tensile force in the elongate member is configured to increase as the length of the elongate member decreases;

securing the first end to a first anatomical structure of the patient'"'"'s upper airway; and

securing the second end to a second anatomical structure of the patient'"'"'s upper airway, wherein the second anatomical structure is spaced from the first anatomical structure by a first distance.

47. The method of claim 46, wherein the first end includes a first anchoring structure, and the second end includes a second anchoring structure.

48. The method of claim 46, wherein the elongate member includes an expanded PTFE sheath surrounding a portion of the elongate member, the expanded PTFE sheath configured to promote tissue ingrowth.

49. The method of claim 46, wherein one of the first and second anatomical structures includes a hyoid bone.

50. The method of claim 46, wherein one of the first and second anatomical structures includes a thyroid cartilage.

51. The method of claim 46, wherein one of the first and second anatomical structures includes a chin.