Methods and devices for treating sleep apnea and snoring

• US 20080188947A1
• Filed: 01/29/2008
• Published: 08/07/2008
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: LinguaFlex, Inc.
• Original Assignee: LinguaFlex, Inc.
• Inventors: Sanders, Ira
• Granted Patent: US 8,074,655 B2
• Time in Patent Office: Days
• US Class Current: 623/23.72
• 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 paryngeal wall, a tonsillar fold, or a soft palate and the force prevents obstruction of the patient'"'"'s airway.

2. The method of claim 1 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.

3. The method of claim 1 wherein at least a portion of the retractor member or at least a portion of the anchor member is positioned behind the pharyngoglossal fold.

4. 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.

5. 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.

6. The method of claim 1 wherein the anchor member couples to a tooth.

7. 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.

8. 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.

9. A tissue retractor for treatment of a breathing disorder, the tissue retractor comprising:

a) a retractor member comprising a first magnet;

b) a shaft sized for placement in a patient'"'"'s oral cavity or pharynx, wherein a first end of the shaft comprises a second magnet or other material that attracts to the first magnet; and

c) an anchor member connected at or near a 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 a soft tissue in the patient'"'"'s oral cavity or pharynx, and the force prevents obstruction of the patient'"'"'s airway.

10. The tissue retractor of claim 9 wherein the anchor member couples to a tooth.

11. The tissue retractor of claim 9 wherein the anchor member surrounds at least a portion of the tooth.

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

a) positioning a clamp sized for placement in a patient'"'"'s upper airway on a mucosal fold located in a patient'"'"'s upper airway; and

b) 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.

13. The method of claim 12 wherein the pressure is not greater than the perfusion pressure of the mucosal fold.

14. The method of claim 12 wherein the clamp comprises a first magnet and a second magnet of opposite polarity.

15. The method of claim 12 wherein the clamp comprises a first magnet connected at or near a first end of a shaft and a second magnet of opposite polarity connected at or near a second end of the shaft.

16. The method of claim 12 a first arm connected at or near a first end of a shaft and a second arm connected at or near a second end of the shaft, the first arm is attracted to the second arm by a spring force.

17. The method of claim 12 wherein the clamp comprises a shaft and the shaft exerts at least one of a protracting or a retracting force on the mucosal fold.

18. The method claim 12, the method further comprising:

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

d) 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, wherein 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 protracting force between the mucosal fold and the other portion of the mucosal fold to prevent obstruction of the patient'"'"'s airway.

19. A tissue clamp for treatment of a breathing disorder, the tissue clamp comprising:

a) a first arm connected at or near a first end of a shaft; and

b) a second arm connected at or near a second end of the shaft, wherein the first arm is attracted to the second arm by a force,

wherein the first arm, the second arm, and the shaft are dimensioned to surround a mucosal fold located in a patient'"'"'s upper airway, wherein the force indents at least a portion of the mucosal fold to prevent obstruction of the patient'"'"'s airway.

20. The method of claim 19 wherein the force is a magnetic force.

21. The method of claim 19 wherein the force is a spring force.

22. The method of claim 19 wherein the shaft exerts at least one of a protracting or a retracting force on the mucosal fold.

23. A method for treatment of a breathing disorder, the method comprising implanting into a tonsillar fold in a patient'"'"'s oral cavity or pharynx a shaft with a retractor member connected at a first end and an anchor member connected at a second end, wherein at least one of the shaft, the retractor member and the anchor member interact to distribute a force on a soft tissue in the patient'"'"'s oral cavity or pharynx, and the force prevents obstruction of the patient'"'"'s airway.

24. 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.

25. The method of claim 24 wherein the force pushes at least a portion of the soft palate to open at least a portion of the patient'"'"'s airway.

26. The method of claim 24 wherein the anchor member surrounds at least a portion of a tooth.

27. The method of claim 24 wherein the anchor member is external to an anterior tonsillar fold.

28. 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 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.

29. The method of claim 28 wherein the shaft is external to the soft tissue.

30. The method of claim 28 wherein the second portion of the retractor member has a low profile when not connected to the first end of the shaft.

31. The method of claim 28 wherein at least a portion of the retractor member is positioned in the region of the pharyngoglossal fold.

32. The method of claim 28 the anchor member comprising an anchor member first portion implanted in a soft tissue located in a patient'"'"'s oral cavity or pharynx and an anchor member second portion external to the soft tissue.

33. The method of claim 28 wherein the anchor member comprises a band surrounding at least a portion of the external diameter of a patient'"'"'s tongue.

34. The method of claim 28 wherein the anchor member comprises a stud on an external surface of the patient'"'"'s tongue.

35. A tissue retractor for treatment of a breathing disorder, the tissue retractor comprising:

a) a retractor member with a first portion sized for implantation into a soft tissue located in a patient'"'"'s oral cavity or pharynx and a second portion sized for placement external to the soft tissue;

b) an anchor member; and

c) a shaft, a portion of the shaft contacting the second portion of the retractor member and another portion of the shaft connecting at or near the anchor member,

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.

36. The tissue retractor of claim 35 wherein the shaft is external to the soft tissue.

37. The tissue retractor of claim 35 wherein a first end of the shaft connects at or near the anchor member, a second end of the shaft connects at or near a second anchor member, and the portion of the shaft exerts the pressure on the second portion of the retractor member.

38. The tissue retractor of claim 37, wherein the 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.

39. The tissue retractor of claim 35 wherein the second portion of the retractor member has a low profile when not contacting the shaft.

40. The tissue retractor of claim 35 wherein the anchor member comprises a band surrounding at least a portion of the external diameter of a patient'"'"'s tongue.

41. The tissue retractor of claim 35 wherein the anchor member comprises a stud on the external surface of a patient'"'"'s tongue.

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

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

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

43. The method of claim 42, 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.

44. The method of claim 42, the method further comprising 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.

45. The method of claim 42, 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.

46. The method of claim 42, wherein at least a portion of the shaft is internal to the tongue.

47. 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 retractor 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.

48. The method of claim 47 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.

49. The method of claim 47, 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.

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

a) inserting at least a portion of a shaft into a patient'"'"'s tongue;

b) connecting a retractor member at or near a first end of the shaft at an external surface of the tongue;

c) connecting an anchor member at or near a second end of the shaft;

d) surrounding at least a portion of the external diameter of the tongue with a band disposed adjacent the retractor member; and

e) 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 tongue so as to prevent obstruction of the patient'"'"'s airway.

51. The method of claim 50 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 tongue so as to prevent obstruction of the patient'"'"'s airway.

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

a) a shaft sized for insertion into a patient'"'"'s tongue;

b) a retractor member connected at or near a first end of the shaft, wherein the retractor member is positioned at the external surface of the tongue;

c) an anchor member connected at or near a second end of the shaft; and

d) a band sized to surround at least a portion of the external diameter of the tongue,

wherein the band moves to exert a pressure on at least one of a portion of the retractor member and a portion of the shaft to prevent deformation of a portion of the tongue so as to prevent obstruction of the patient'"'"'s airway.

53. The tissue retractor of claim 52 wherein the band is dimensioned to rotate and push at least one of a portion of the retractor member and a portion of the shaft.

54. 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.

55. The method of claim 54 wherein the portion of the patient'"'"'s tongue is the base of the patient'"'"'s tongue.

56. The method of claim 54 wherein one or more of the shaft, the retractor member, and the anchor member is bioresorbable.

57. The method of claim 54 wherein the portion of the patient'"'"'s tongue is the midline of the tongue.

58. The method of claim 54 wherein the middle layer comprises the midline septum.

59. The method of claim 54 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.

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

a) inserting a shaft into a soft palate located in a patient'"'"'s oral cavity or pharynx;

b) connecting a retractor member at or near a first end of the shaft; and

c) connecting an anchor member at or near a second end of the shaft,

wherein at least one of the shaft, the retractor member and the anchor member 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.

61. The method of claim 60 wherein at least one of the retractor member or the anchor member is on an external surface of the soft palate.

62. The method of claim 61 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.

63. The method of claim 62 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.

64. The method of claim 61 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.

65. A tissue retractor for treatment of at least one of snoring and sleep apnea, the tissue retractor comprising:

a) a shaft sized for insertion into a patient'"'"'s soft tissue;

b) a retractor member connected at or near a first end of the shaft, the retractor member positioned on an external surface of the patient'"'"'s soft tissue;

c) an anchor member connected at or near a second end of the shaft; and

d) a band, the band is sized to surround at least a portion of the external diameter of the patient'"'"'s soft tissue, a first end of the band is connected at or near the retractor member, and a second end of the band is connected at or near the anchor member,

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 tissue so as to prevent obstruction of the patient'"'"'s airway.

66. The tissue retractor of claim 65, wherein the anchor member is positioned on an external surface of the patient'"'"'s soft tissue.

67. A method for treatment of a breathing disorder in a horse, the method comprising:

a) inserting a shaft into a horse'"'"'s tongue;

b) connecting a retractor member at or near a first end of the shaft; and

c) connecting an anchor member at or near a second end of the shaft, the anchor member is external to the horse'"'"'s mandible,

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

68. A tissue retractor for treatment of a breathing disorder in a horse, the tissue retractor comprising:

a) a shaft sized for insertion into a horse'"'"'s tongue;

b) a retractor member connected at or near a first end of the shaft; and

c) an anchor member connected at or near a second end of the shaft,

wherein the anchor member is external to the horse'"'"'s mandible and at least one of the shaft, the retractor member, and the anchor member interact to exert a pressure that prevents obstruction of the horse'"'"'s airway.

69. A method for treatment of a breathing disorder in a horse, the method comprising:

a) inserting a shaft into a horse'"'"'s tongue;

b) connecting a retractor member at or near a first end of the shaft; and

c) connecting an anchor member at or near a second end of the shaft, the anchor member is external to the horse'"'"'s tongue; and

d) hooking the anchor member to a bit of a horse'"'"'s bridal;

wherein at least one of the shaft, the retractor member, the anchor member, and the bit interact to exert a pressure that prevents obstruction of the horse'"'"'s airway.

70. A tissue retractor for treatment of a breathing disorder in a horse, the tissue retractor comprising:

a) a shaft sized for insertion into a horse'"'"'s tongue;

b) a retractor member connected at or near a first end of the shaft; and

c) an anchor member connected at or near a second end of the shaft,

wherein the anchor member is external to the horse'"'"'s tongue and the anchor member hooks to a bit of a horse'"'"'s bridal and at least one of the shaft, the retractor member, the anchor member, and the bit interact to exert a pressure that prevents obstruction of the horse'"'"'s airway.

71. A method for treatment of a breathing disorder in a horse, the method comprising:

a) inserting a shaft through an epiglottis and a soft palate;

b) connecting a retractor member at or near a first end of the shaft, the retractor member is external to the soft palate; and

c) connecting an anchor member at or near a second end of the shaft, the anchor member is external to the epiglottis,

wherein at least one of the shaft, the retractor member, and the anchor member interact to maintain the epiglottis adjacent to the soft palate and to prevent obstruction of the horse'"'"'s airway.

72. The method of claim 71, the method further comprising:

d) positioning a second retractor member in the region of the pharyngoglossal fold;

e) connecting a first end of a second shaft at or near the second retractor member; and

f) connecting a second end of a shaft at or near a second anchor member, attaching at least a portion of the second anchor member to the soft palate,

wherein at least one of the second shaft, the second retractor member and the second anchor member interact to distribute a force and to prevent obstruction of the horse'"'"'s airway.

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

a) positioning a device on the floor of a patient'"'"'s mouth; and

b) applying a force to the device that displaces at least a portion of the floor of the patient'"'"'s mouth and moves an adjacent soft tissue to prevent deformation of at least a portion of the patient'"'"'s soft tissue so as to prevent obstruction of the patient'"'"'s airway.

74. The method of claim 73 wherein the soft tissue is the patient'"'"'s tongue and the device moves at least a portion of the tongue in a direction away from the patient'"'"'s airway.

75. The method of claim 73 wherein the device comprises a bolster and at least one of a shaft, a dental anchor, and a palatal prosthesis.

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

a) positioning a vacuum device on a segment of a soft tissue located in a patient'"'"'s oral cavity or pharynx; and

b) applying a vacuum to the vacuum device to displace at least a portion of the segment to alter the shape of the at least a portion of the segment and to prevent deformation of at least a portion of the soft tissue so as to prevent obstruction of the patient'"'"'s airway.

77. The method of claim 76 wherein the vacuum device comprises one or more of a suction cup, a tube, and a pump.

78. The method of claim 76 wherein the soft tissue is a tongue.

79. The method of claim 76 further comprising applying a viscous material to the soft tissue prior to positioning the vacuum device.

80. A tissue retractor for treatment of a breathing disorder, the tissue retractor comprising:

a) an anchor member sized for placement on or in a patient'"'"'s soft palate;

b) a shaft having a first end and a second end, the first end connected to the anchor member; and

c) a retractor member connected at or near the second end of the shaft; and

wherein at least one of the shaft and the retractor member is positioned on or in a soft tissue located in the patient'"'"'s oral cavity or pharynx, and the anchor member, the shaft, and the retractor member exert a force that prevents deformation of at least a portion of the soft tissue so as to prevent obstruction of the patient'"'"'s airway.

81. The tissue retractor of claim 80 wherein the force is one of a retraction force or a protraction force.

82. The tissue retractor of claim 80 wherein the soft tissue is the soft palate, the pharyngoglossal fold, the floor of mouth, or the tongue.

83. The tissue retractor of claim 80 wherein the retractor member is a tongue stud on the surface of a tongue.

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

a) positioning a palatal prosthesis on or in a patient'"'"'s soft palate;

b) positioning a retractor member on or in a soft tissue located in the patient'"'"'s oral cavity or pharynx;

c) connecting a first end of a shaft to the palatal prosthesis; and

d) connecting a second end of the shaft to the retractor member,

wherein at least one of the palatal prosthesis, the shaft, and the retractor member interact to exert a force that prevents deformation of at least a portion of the soft tissue so as to prevent obstruction of the patient'"'"'s airway.

85. The method of claim 84 wherein at least one of the palatal prosthesis, the shaft, and the retractor member interact to exert one of a retraction force or a protraction force that prevents deformation of at least a portion of the soft tissue so as to prevent obstruction of the patient'"'"'s airway.

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

a) positioning a device on a soft tissue in a patient'"'"'s mouth;

b) applying a suction force to the device to suction at least a portion of the soft tissue into the device; and

c) retracting the device to displace at least a portion of the soft tissue so as to prevent obstruction of the patient'"'"'s airway.

87. The method of claim 86 wherein the soft tissue is the patient'"'"'s tongue and the device moves at least a portion of the tongue in a direction away from the patient'"'"'s airway.

88. The method of claim 86 wherein a shaft comprising a lumen provides the suction force and retracting the device comprises moving the shaft in a direction away from the patient'"'"'s airway.

89. The method of claim 86 wherein the device resists release of the at least a portion of the soft tissue when the suction force is released.