Methods and devices for treating sleep apnea and snoring

• US 8,074,655 B2
• Filed: 01/29/2008
• Issued: 12/13/2011
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: LinguaFlex, Inc.
• Original Assignee: LinguaFlex, Inc.
• Inventors: Sanders, Ira
• Primary Examiner(s): Bianco, Patricia
• Assistant Examiner(s): Hicks, Victoria J
• Application Number:
  US12/011,782
• Publication Number:
  US 20080188947A1
• Time in Patent Office: 1,414 Days
• Field of Search: 128/848, 128/897, 128/898, 600/201, 600/203, 600/235, 600/237, 600/238, 600/239, 600/240, 600/241, 600/242
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61F 2/00 Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents as cosmetic articles, see the relevant subclasses, e.g. wigs, hair pieces, A41G3/00, A41G5/00; artificial nails A45D31/00; dental prostheses A61C13/00; materials for prostheses A61L27/00; artificial hearts A61M60/00; artificial kidneys A61M1/14
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

Methods and devices to prevent and/or treat breathing disorders (e.g., upper airways disorders) in mammals related to impaired airflow are described. Methods and devices apply force to soft tissue that avoids obstruction of airflow in the mammel'"'"'s airway. Breathing disorders that are avoided by the methods and/or devices include apnea.

Claims

1. A method for treatment of a breathing disorder, the method comprising:

a) positioning a shaft having a first end and a second end in a patient'"'"'s oral cavity or pharynx;

b) connecting one of a retractor member and an anchor member at or near the first end and in the region of the pharyngoglossal fold;

c) connecting the other of the retractor member and the anchor member at or near the second end of the shaft,

wherein at least one of the shaft, the retractor member, and the anchor member interact to distribute a force on at least one of a tongue base, a lateral pharyngeal wall, a tonsillar fold, or a soft palate and the force prevents obstruction of the patient'"'"'s airway and wherein at least a portion of the retractor member or at least a portion of the anchor member is positioned on an external surface of the pharyngoglossal fold.

2. The method of claim 1 wherein the retractor member is a first arm and the anchor member is a second arm, the first arm, second arm, and shaft form a clamp sized for placement in a patient'"'"'s upper airway on a mucosal fold located in the patient'"'"'s upper airway and further comprising:

positioning the clamp on the mucosal fold located in the patient'"'"'s upper airway; and

compressing the mucosal fold with the clamp at a pressure that substantially maintains the clamp in its position on the mucosal fold, wherein the clamp indents at least a portion of the mucosal fold to prevent obstruction of the patient'"'"'s airway.

3. The method of claim 2 wherein the pressure is not greater than the perfusion pressure of the mucosal fold.

4. The method of claim 2 wherein the clamp comprises a first magnet and a second magnet of opposite polarity.

5. The method of claim 2 wherein the clamp comprises a first magnet connected at or near the first end of the shaft and a second magnet of opposite polarity connected at or near a second end of the shaft.

6. The method of claim 2 wherein the first arm is connected at or near the first end of the shaft and the second arm is connected at or near a second end of the shaft, the first arm attracted to the second arm by a spring force.

7. The method of claim 2 wherein the shaft exerts at least one of a protracting force or a retracting force on the mucosal fold.

8. The method of claim 2 further comprising:

positioning a second clamp sized for placement in the patient'"'"'s upper airway on another portion of the mucosal fold; and

compressing the other portion of the mucosal fold with the second clamp at a pressure that substantially maintains the second clamp in its position on the other portion of the mucosal fold, therein the second clamp indents at least a portion of the other portion of the mucosal fold and the clamp and the second clamp exert a protecting force between the mucosal fold and the other portion of the mucosal fold to prevent obstruction of the patient'"'"'s airway.

9. The method of claim 1 wherein at least a portion of the retractor member or at least a portion of the anchor member is disposed inside the region of the pharyngoglossal fold.

10. The method of claim 1 wherein the first end of the shaft comprises a first magnet and one of the retractor member and the anchor member comprises a second magnet or a material that attracts to the first magnet.

11. The method of claim 1 wherein the anchor member is configured to couple to a tooth.

12. The method of claim 1 wherein at least a portion of the shaft is internal to at least one of the pharyngoglossal fold and a tongue.

13. The method of claim 1 wherein at least a portion of the anchor member or at least a portion of the retractor member is positioned inside the patient'"'"'s mouth, in the region of the patient'"'"'s frenulum, external to the patient'"'"'s mouth, adjacent a surface of a tongue, inside a tongue, or external to a soft palate.

14. A method for treatment of a breathing disorder, the method comprising:

a) positioning a shaft having a first end and a second end in a patient'"'"'s oral cavity or pharynx;

b) connecting one of a retractor member and an anchor member at or near the first end and in the region of the pharyngoglossal fold;

c) connecting the other of the retractor member and the anchor member at or near the second end of the shaft,

wherein at least one of the shaft, the retractor member, and the anchor member interact to distribute a force on at least one of a tongue base, a lateral pharyngeal wall, a tonsillar fold, or a soft palate and the force prevents obstruction of the patient'"'"'s airway and wherein at least a portion of the retractor member or at least a portion of the anchor member is positioned behind the pharyngoglossal fold.

15. The method of claim 14 wherein the retractor member is a first arm and the anchor member is a second arm, the first arm, second arm, and shaft form a clamp sized for placement in a patient'"'"'s upper airway on a mucosal fold located in the patient'"'"'s upper airway, the method further comprising:

positioning the clamp on the mucosal fold located in the patient'"'"'s upper airway; and

compressing the mucosal fold with the clamp at a pressure that substantially maintains the clamp in its position on the mucosal fold, wherein the clamp indents at least a portion of the mucosal fold to prevent obstruction of the patient'"'"'s airway.

16. The method of claim 15 wherein the pressure is not greater than the perfusion pressure of the mucosal fold.

17. The method of claim 15 wherein the clamp comprises a first magnet and a second magnet of opposite polarity.

18. The method of claim 15 wherein the clamp comprises a first magnet connected at or near the first end of the shaft and a second magnet of opposite polarity connected at or near a second end of the shaft.

19. The method of claim 15 wherein the first arm is connected at or near the first end of the shaft and the second arm is connected at or near a second end of the shaft, the first arm attracted to the second arm by a spring force.

20. The method of claim 15 wherein the shaft exerts at least one of a protracting force or a retracting force on the mucosal fold.

21. The method of claim 15 further comprising:

positioning a second clamp sized for placement in the patient'"'"'s upper airway on another portion of the mucosal fold; and

compressing the other portion of the mucosal fold with the second clamp at a pressure that substantially maintains the second clamp in its position on the other portion of the mucosal fold, therein the second clamp indents at least a portion of the other portion of the mucosal fold and the clamp and the second clamp exert a protecting force between the mucosal fold and the other portion of the mucosal fold to prevent obstruction of the patient'"'"'s airway.

22. The method of claim 14 wherein at least a portion of the retractor member or at least a portion of the anchor member is disposed inside the region of the pharyngoglossal fold.

23. The method of claim 14 wherein the first end of the shaft comprises a first magnet and one of the retractor member and the anchor member comprises a second magnet or a material that attracts to the first magnet.

24. The method of claim 14 wherein the anchor member is configured to couple to a tooth.

25. The method of claim 14 wherein at least a portion of the shaft is internal to at least one of the pharyngoglossal fold and a tongue.

26. The method of claim 14 wherein at least a portion of the anchor member or at least a portion of the retractor member is positioned inside the patient'"'"'s mouth, in the region of the patient'"'"'s frenulum, external to the patient'"'"'s mouth, adjacent a surface of a tongue, inside a tongue, or external to a soft palate.

27. A method for treatment of a breathing disorder, the method comprising:

a) implanting a first portion of a retractor member into a soft tissue located in a patient'"'"'s oral cavity or pharynx, wherein a second portion of the retractor member is exterior to the soft tissue;

b) connecting a first end of a shaft to the retractor member, wherein the shaft is external to the soft tissue; and

c) connecting an anchor member to a second end of the shaft,

wherein at least one of the retractor member, the shaft, and the anchor member interact to exert a pressure that prevents deformation of at least a portion of the soft tissue that prevents obstruction of the patient'"'"'s airway.

28. The method of claim 27, wherein the soft tissue is a soft palate.

29. The method of claim 28, wherein at least one of the retractor member or the anchor member is on an external surface of the soft palate.

30. The method of claim 29, further comprising a band, a first end of the band connects at or near the retractor member, a second end of the band connects at or near the anchor member, and the band externally surrounds at least a portion of the soft palate.

31. The method of claim 30, wherein at least one of the shaft, the retractor member, the anchor member, and the band interact to exert a pressure that prevents deformation of a portion of the soft palate so as to prevent obstruction of the patient'"'"'s airway.

32. The method of claim 29, further comprising disposing a bolster on an external surface of the soft palate between the external surface of the soft palate and one of the retractor member and the anchor member.

33. The method of claim 27 wherein the second portion of the retractor member has a low profile when not connected to the first end of the shaft.

34. The method of claim 27 wherein at least a portion of the retractor member is positioned in the region of the pharyngoglossal fold.

35. The method of claim 27 wherein the anchor member comprising an anchor member first portion implanted in the soft tissue located in a patient'"'"'s oral cavity or pharynx and an anchor member second portion external to the soft tissue.

36. A method for treatment of a breathing disorder with a retractor member connected at or near a first end of a shaft and an anchor member connected at or near a second end of the shaft, the method comprising:

a) inserting the shaft into a patient'"'"'s tongue between the superior layer and the middle layer;

b) attaching one of the retractor member and the anchor member to the mucosa tissue fascia; and

c) attaching the other of the retractor member and the anchor member to the midline septum tissue fascia,

wherein at least one of the shaft, the retractor member and the anchor member interact to exert a counterforce pressure that prevents a portion of the patient'"'"'s tongue from obstructing the patient'"'"'s oral cavity or pharynx.

37. The method of claim 36 wherein the portion of the patient'"'"'s tongue is the base of the patient'"'"'s tongue.

38. The method of claim 36 wherein one or more of the shaft, the retractor member, and the anchor member is bioresorbable.

39. The method of claim 36 wherein the portion of the patient'"'"'s tongue is the midline of the tongue.

40. The method of claim 36 wherein the middle layer comprises the midline septum.

41. The method of claim 36 further comprising positioning the retractor member, the shaft, and the anchor on a needle, inserting the needle to a desired depth within the patient'"'"'s tongue, and removing the needle.

42. A method for treatment of a breathing disorder, the method comprising:

a) implanting at least a portion of a shaft having a first end and a second end into a tonsillar fold in a patient'"'"'s oral cavity or pharynx;

b) connecting one of a retractor member and an anchor member at or near the first end; and

c) connecting the other of the retractor member and the anchor member at or near the second end,

wherein at least one of the retractor member and the anchor member is external to the tonsillar fold and at least one of the shaft, the retractor member, and the anchor member interact to distribute a force that prevents obstruction of the patient'"'"'s airway.

43. The method of claim 42 wherein the force pushes at least a portion of the soft palate to open at least a portion of the patient'"'"'s airway.

44. The method of claim 42 wherein the anchor member surrounds at least a portion of a tooth.

45. The method of claim 42 wherein the anchor member is external to an anterior tonsillar fold.

46. A method for treatment of a breathing disorder, the method comprising:

a) implanting a first portion of a retractor member into a soft tissue located in a patient'"'"'s oral cavity or pharynx, wherein a second portion of the retractor member is exterior to the soft tissue;

b) connecting a first end of a shaft to the retractor member; and

c) connecting an anchor member to a second end of the shaft, wherein the anchor member comprises a band surrounding at least a portion of the external diameter of a patient'"'"'s tongue,

wherein at least one of the retractor member, the shaft and the anchor member interact to exert a pressure that prevents deformation of at least a portion of the soft tissue that prevents obstruction of the patient'"'"'s airway.

47. The method of claim 46, further comprising moving the band to exert a pressure on at least one of a portion of the retractor member and at least a portion of the shaft to prevent deformation of at least a portion of the soft tissue so as to prevent obstruction of the patient'"'"'s airway.

48. The method of claim 47, wherein moving the band comprises rotating the band and pushing at least a portion of the retractor member and at least a portion of the shaft to displace at least a portion of the soft tissue so as to prevent obstruction of the patient'"'"'s airway.

49. A method for treatment of a breathing disorder, the method comprising:

a) positioning a first anchor member in a first region of soft tissue located in a patient'"'"'s oral cavity or pharynx;

b) positioning a second anchor member in a second region of soft tissue located in the patient'"'"'s oral cavity or pharynx;

c) inserting a first portion of a retractor member into a third region of soft tissue located in the patient'"'"'s oral cavity or pharynx, wherein a second portion of the retractor member is exterior to the third region of soft tissue; and

d) connecting a first end of a shaft at or near the first anchor member and connecting a second end of the shaft at or near the second anchor member,

wherein at least one of the first anchor member, the second anchor member, the refractor member, and the shaft interact to exert a pressure that prevents deformation of at least a portion of soft tissue to prevent obstruction of the patient'"'"'s airway.

50. The method of claim 49 wherein the first anchor member comprises a first magnet, the first end of the shaft comprises a second magnet that attracts to the first magnet, the second anchor member comprises a third magnet, and the second end of the shaft comprises a fourth magnet that attracts to the third magnet.

51. The method of claim 49, wherein at least a portion of the shaft exerts a pressure on the retractor member that prevents deformation of the third region of soft tissue.

52. A method for treatment of a breathing disorder, the method comprising:

a) positioning a first anchor member in the region of a first pharyngoglossal fold;

b) positioning a second anchor member in the region of a second pharyngoglossal fold; and

c) connecting a first end of a shaft at or near the first anchor member and connecting a second end of the shaft at or near the second anchor member, wherein at least one of the first anchor member, the second anchor member and the shaft interact to distribute a force on at least a portion of a tongue that prevents obstruction of the patient'"'"'s airway and wherein the first anchor member comprises a first magnet, the first end of the shaft comprises a second magnet that attracts to the first magnet, the second anchor member comprises a third magnet, and the second end of the shaft comprises a fourth magnet that attracts to the third magnet.

53. The method of claim 52, wherein at least a portion of the shaft is internal to the tongue.

54. A method for treatment of a breathing disorder, the method comprising:

a) positioning a first anchor member in the region of a first pharyngoglossal fold;

b) positioning a second anchor member in the region of a second pharyngoglossal fold.

c) connecting a first end of a shaft at or near the first anchor member and connecting a second end of the shaft at or near the second anchor member, wherein at least one of the first anchor member, the second anchor member and the shaft interact to distribute a force on at least a portion of a tongue that prevents obstruction of the patient'"'"'s airway; and

d) inserting a first portion of a retractor member in the tongue, wherein a second portion of the retractor member is exterior to the tongue, and at least a portion of the shaft contacts the second portion of the retractor member.

55. The method of claim 54, wherein at least a portion of the shaft is internal to the tongue.

56. A method for treatment of a breathing disorder, the method comprising:

a) positioning a first anchor member in the region of a first pharyngoglossal fold;

b) positioning a second anchor member in the region of a second pharyngoglossal fold;

c) connecting a first end of a shaft at or near the first anchor member and connecting a second end of the shaft at or near the second anchor member, wherein at least one of the first anchor member, the second anchor member and the shaft interact to distribute a force on at least a portion of a tongue that prevents obstruction of the patient'"'"'s airway; and

wherein a first portion of a retractor member is inserted in the tongue, a second portion of the retractor member is exterior to the tongue, and at least a portion of the shaft contacts the second portion of the retractor member, wherein at least one of the first anchor member, the second anchor member, the retractor member, and the shaft interact to distribute a force on at least a portion of the tongue that prevents obstruction of the patient'"'"'s airway.

57. The method of claim 56, wherein at least a portion of the shaft is internal to the tongue.

58. A method for treatment of a breathing disorder, the method comprising:

a) implanting a first portion of a retractor member into a soft tissue located in a patient'"'"'s oral cavity or pharynx, wherein a second portion of the retractor member is exterior to the soft tissue;

b) connecting a first end of a shaft to the retractor member; and

c) connecting an anchor member to a second end of the shaft,

the anchor member comprises a stud on an external surface of the patient'"'"'s tongue,

wherein at least one of the retractor member, the shaft and the anchor member interact to exert a pressure that prevents deformation of at least a portion of the soft tissue that prevents obstruction of the patient'"'"'s airway.