Method and device for the treatment of obstructive sleep apnea and snoring

• US 8,925,551 B2
• Filed: 02/28/2005
• Issued: 01/06/2015
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: LinguaFlex, Inc.
• Original Assignee: LinguaFlex, Inc.
• Inventors: Sanders, Ira
• Primary Examiner(s): Hicks, Victoria J
• Application Number:
  US10/597,590
• Publication Number:
  US 20090014012A1
• Time in Patent Office: 3,599 Days
• Field of Search: 128/848, 128/887, 600/237, 600/32, 600/30, 600/201, 600/206, 600/208, 600/217, 600/242, 600/238, 600/239, 600/240
• 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 17/24 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 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0548 Oral electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

The device relates to methods and devices for the treatment of obstructive sleep apnea syndrome.

Claims

1. A tissue retractor for treatment of at least one of snoring and sleep apnea in a patient that prevents deformation of a tongue of the patient, the tissue retractor comprising:

a) a flexible shaft configured for transmucosal insertion into the patient'"'"'s tongue;

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

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

wherein at least one of the retractor member or the anchor member is configured to be positioned on an external surface of the patient'"'"'s tongue, and neither the retractor member nor the anchor member are configured to be tethered to bone,

such that a tension from the flexible shaft is configured to exert an amount of pressure sufficient to prevent the external surface of the patient'"'"'s tongue from falling toward a soft tissue located in an oral cavity or a pharynx of the patient when the patient'"'"'s tongue is relaxed during sleep but permit flexing of the patient'"'"'s tongue by not impairing normal movement of the patient'"'"'s tongue during speech and swallowing,

the tissue retractor further configured for at least one of removal, reinsertion, or subsequent retensioning by adjustment of the tissue retractor by the patient for effectiveness and comfort.

2. The tissue retractor of claim 1 wherein the flexible shaft is sized for insertion through the patient'"'"'s tongue.

3. The tissue retractor of claim 1 wherein the exerted amount of pressure is a counterforce pressure that prevents deformation of the external surface of the patient'"'"'s tongue, the exerted pressure is a counterforce pressure that creates an indentation in the external surface of the patient'"'"'s tongue, or the retractor member, the flexible shaft, and the anchor member adjust to alter the counterforce pressure exerted on the patient'"'"'s tongue.

4. The tissue retractor of claim 1 wherein the tissue retractor is formed from one or more biocompatible materials.

5. The tissue retractor of claim 1 wherein at least one of the retractor member, the flexible shaft, and the anchor member comprises an inflatable tube, or the flexible shaft comprises an internal passageway for adding a fluid.

6. The tissue retractor of claim 1 wherein the external surface of the patient'"'"'s tongue is a centerline of a tongue curve.

7. The tissue retractor of claim 1 wherein at least one of the retractor member and the anchor member is disengageable from the flexible shaft.

8. The tissue retractor of claim 1 further comprising a connection configured to couple to at least one of the patient'"'"'s pharynx, the patient'"'"'s oral cavity, a tooth of the patient, a dental device, and a mount exterior to a mouth of the patient.

9. The tissue retractor of claim 1 wherein the tissue retractor is adjustable.

10. The tissue retractor of claim 1 wherein the anchor member is detachable from the flexible shaft.

11. A tissue retractor for treatment of sleep apnea in a patient that prevents a deformation of an external surface of a mucosa covering a soft tissue located in an oral cavity or a pharynx of the patient, the tissue retractor comprising:

a) a flexible shaft configured for transmucosal insertion into the mucosa covering and the soft tissue;

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

c) an anchor member connected at or near a second end of the flexible shaft, wherein at least one of the retractor member or the anchor member is configured to be positioned on the external surface of the mucosa covering and the soft tissue, and neither the retractor member nor the anchor member are configured to be tethered to bone,

such that a tension from the flexible shaft is configured to exert an amount of pressure sufficient to prevent the deformation of the external surface of the mucosa covering and the soft tissue when relaxed during sleep but permit flexing of the mucosa covering and the soft tissue by not impairing normal movement of the mucosa covering and the soft tissue during speech and swallowing,

the tissue retractor further configured for at least one of removal, reinsertion, or subsequent retensioning by adjustment of the tissue retractor by the patient for effectiveness and comfort.

12. The tissue retractor of claim 11 wherein the flexible shaft comprises an internal passageway for adding a fluid.

13. The tissue retractor of claim 12 wherein the flexible shaft comprises a regulator for said fluid.

14. The tissue retractor of claim 11 wherein the exerted pressure is adapted to stiffen the mucosa covering and the soft tissue to prevent deformation of the external surface of the mucosa covering and the soft tissue, the exerted pressure is a counterforce pressure that prevents deformation of the external surface of the mucosa covering and the soft tissue, the exerted pressure is a counterforce pressure that creates an indentation in the external surface of the mucosa covering and the soft tissue, and at least one of the retractor member, the flexible shaft, and the anchor member are configured to be adjustable to alter the exerted pressure on the mucosa covering and the soft tissue.

15. The tissue retractor of claim 11 wherein at least one of the retractor member, the flexible shaft, and the anchor member comprises an inflatable tube.

16. The tissue retractor of claim 11 wherein at least one of the retractor member and the anchor member is disengageable from the flexible shaft.

17. The tissue retractor of claim 11 further comprising a connection configured to couple to at least one of the patient'"'"'s pharynx, the patient'"'"'s oral cavity, a tooth of the patient, a dental device, and a mount exterior to a mouth of the patient.

18. The tissue retractor of claim 11 wherein the tissue retractor is adjustable.

19. The tissue retractor of claim 11 wherein the anchor member is detachable from the flexible shaft.

20. A method for treatment of at least one of snoring and sleep apnea in a patient that prevents a deformation of a mucosa covering a soft tissue located in an oral cavity or a pharynx of the patient, the method comprising:

a) inserting a flexible shaft, configured for transmucosal insertion, into the mucosa covering and the soft tissue of a tongue of the patient;

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

c) connecting an anchor member at or near a second end of the flexible shaft, forming a connected retractor member, flexible shaft, and anchor member,

wherein neither the retractor member nor the anchor member are configured to be tethered to bone, and at least one of the retractor member and the anchor member is positioned on an external surface of the patient'"'"'s tongue, and at least one of the shaft, the retractor member and the anchor member interact such that a tension from the flexible shaft is configured to exert an amount of pressure sufficient to prevent the external surface of the patient'"'"'s tongue from falling toward a soft tissue located in the patient'"'"'s oral cavity or pharynx when the patient'"'"'s tongue is relaxed during sleep but permit flexing of the patient'"'"'s tongue by not impairing normal movement of the patient'"'"'s tongue during speech and swallowing,

the connected retractor member, flexible shaft, and anchor member further configured for at least one of removal, reinsertion, or subsequent retensioning by adjustment of the connected retractor member, flexible shaft, and anchor member by the patient for effectiveness and comfort.

21. The method of claim 20 wherein the amount of pressure creates an indentation in the external surface of the patient'"'"'s tongue.

22. The method of claim 20 further comprising the step of:

d) adjusting at least one of the retractor member, the shaft, and the anchor member to alter the amount of pressure.

23. The method of claim 20 wherein the first end of the flexible shaft is connected at or near a base of the patient'"'"'s tongue and the second end of the flexible shaft is connected at or near a frenulum of the patient.

24. The method of claim 20 wherein the anchor member is in communication with a muscle that is active during sleep, or the anchor member is connected to at least one of a tooth of the patient'"'"'s tooth, a dental device, and a mount exterior to the patient'"'"'s oral cavity.

25. The method of claim 20 wherein at least a portion of at least one of the flexible shaft, the retractor member and the anchor member is positioned in an epiglottis of the patient, both the retractor member and the anchor member are positioned adjacent a superior surface of the patient'"'"'s tongue, or the retractor member is on one side of a frenulum of the patient, the flexible shaft is beneath a tongue curve, and the anchor member is on the other side of the frenulum.

26. The method of claim 20 further comprising positioning the retractor member, the flexible shaft, and the anchor on a needle, inserting the needle to a desired depth within the patient'"'"'s tongue, and removing the needle.

27. The method of claim 20 wherein step a) further comprises:

a1) positioning the flexible shaft in a needle bore;

a2) inserting the needle bore at or near a junction of a frenulum of the patient and the patient'"'"'s tongue blade with a tip of the needle bore oriented toward the patient'"'"'s tongue curve;

a3) advancing the needle bore through the patient'"'"'s tongue; and

a4) removing the needle bore while maintaining the flexible shaft in the patient'"'"'s tongue.

28. A method for treatment of a breathing disorder in a patient that prevents a deformation of an external surface of a mucosa covering a soft tissue located in an oral cavity or a pharynx of the patient, the method comprising:

a) inserting a flexible shaft, configured for transmucosal insertion, into the mucosa covering and the soft tissue located in the patient'"'"'s oral cavity or pharynx;

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

c) connecting an anchor member at or near a second end of the flexible shaft, forming a connected retractor member, flexible shaft, and anchor member,

wherein neither the retractor member nor the anchor member are configured to be tethered to bone, and at least one of the retractor member and the anchor member is positioned on an external surface of the soft tissue and at least one of the shaft, the retractor member and the anchor member interact such that a tension from the flexible shaft exerts an amount of pressure sufficient to prevent the deformation of the external surface of the mucosa covering and the soft tissue when relaxed during sleep but permit flexing of the mucosa covering and the soft tissue by not impairing normal movement of the mucosa covering and the soft tissue during speech and swallowing, the connected retractor member, flexible shaft, and anchor member further configured for at least one of removal, reinsertion, or subsequent retensioning by adjustment of the connected retractor member, flexible shaft, and anchor member by the patient for effectiveness and comfort.

29. The method of claim 28 wherein the amount of pressure is a counterforce pressure that creates an indentation in the external surface of the mucosa covering, the amount of pressure stiffens the mucosa covering and the soft tissue to prevent deformation of the external surface of the mucosa covering, or the pressure is amount of a counterforce pressure that prevents deformation of the external surface of the mucosa covering.

30. The method of claim 28 further comprising the step of:

d) adjusting at least one of the retractor member, the shaft, and the anchor member to alter the amount of pressure.

31. The method of claim 28 wherein the anchor member is in communication with the external surface of the mucosa covering of a muscle in the patient'"'"'s oral cavity that is active during sleep.

32. The method of claim 28 wherein the anchor member is connected to at least one of a tooth of the patient, a dental device, and a mount exterior to the patient'"'"'s oral cavity.

33. The method of claim 28 wherein at least a portion of at least one of the flexible shaft, the retractor member and the anchor member is positioned in an epiglottis of the patient.

34. The method of claim 28 further comprising positioning the retractor member, the flexible shaft, and the anchor on a needle and inserting the needle to a desired depth within the soft tissue.

35. A tissue retractor for treatment of at least one of snoring and sleep apnea in a patient, the tissue retractor comprising:

a) a flexible shaft configured for transmucosal insertion into a tongue of the patient;

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

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

wherein at least one of the retractor member or the anchor member is configured to be positioned on an external surface of the patient'"'"'s tongue, and neither the retractor member nor the anchor member are configured to be tethered to bone,

such that a tension from the flexible shaft is configured to exert an amount of pressure sufficient to prevent at least a portion of the patient'"'"'s tongue from collapsing toward a soft tissue located in an oral cavity or a pharynx of the patient when the patient'"'"'s tongue is relaxed during sleep but permit flexing of the patient'"'"'s tongue by not impairing normal movement of the patient'"'"'s tongue during speech and swallowing,

the tissue retractor further configured for at least one of removal, reinsertion, or subsequent retensioning by adjustment of the tissue retractor by the patient for effectiveness and comfort.

36. The tissue retractor of claim 35 wherein the flexible shaft is removable from the patient'"'"'s tongue.

37. The tissue retractor of claim 35 wherein the tissue retractor is adjustable.

38. The tissue retractor of claim 35 wherein the anchor member is detachable from the flexible shaft.

39. A tissue retractor for treatment of sleep apnea in a patient that prevents deformation of a soft tissue located in an oral cavity or a pharynx of the patient, the tissue retractor comprising:

a) a flexible shaft configured for transmucosal insertion into the soft tissue;

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

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

wherein the retractor member and the anchor member are configured to maintain a position on an external surface of the soft tissue, and neither the retractor member nor the anchor member are configured to be tethered to bone,

such that a tension from the flexible shaft is configured to exert an amount of pressure sufficient to prevent deformation of the external surface of the soft tissue when a tongue of the patient is relaxed during sleep but permit flexing of the patient'"'"'s tongue by not impairing normal movement of the patient'"'"'s tongue during speech and swallowing,

the tissue retractor further configured for at least one of removal, reinsertion, or subsequent retensioning by adjustment of the tissue retractor by the patient for effectiveness and comfort.

40. The tissue retractor of claim 39 wherein the tissue retractor is adjustable.

41. The tissue retractor of claim 39 wherein the anchor member is detachable from the flexible shaft.

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

a) inserting a flexible shaft into a soft tissue located in an oral cavity or a pharynx of the patient;

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

c) connecting an anchor member at or near a second end of the flexible shaft, forming a connected retractor member, flexible shaft, and anchor member,

wherein each of the flexible shaft, the retractor member, and the anchor member contact solely soft tissue, neither the retractor member nor the anchor member are configured to be tethered to bone, and the shaft, the retractor member, and the anchor member interact such that a tension from the flexible shaft is configured to exert an amount of pressure sufficient to prevent deformation of an external surface of the soft tissue when a tongue of the patient is relaxed during sleep but permit flexing of the patient'"'"'s tongue by not impairing normal movement of the patient'"'"'s tongue during speech and swallowing,

the connected retractor member, flexible shaft, and anchor member further configured for at least one of removal, reinsertion, or subsequent retensioning by adjustment of the connected retractor member, flexible shaft, and anchor member by the patient for effectiveness and comfort.

43. The method of claim 42 wherein the soft tissue is the patient'"'"'s tongue, the retractor member contacts the patient'"'"'s tongue, which retracts at least a portion of the patient'"'"'s tongue curve, and the anchor member is implanted in a genioglossus muscle of the patient.

44. A device for treatment of a breathing disorder in a patient, the device having a first end, a second end, and a shaft disposed therebetween, the shaft is flexible and adapted for transmucosal insertion through a soft tissue located in an oral cavity or a pharynx of the patient, with at least one of the first end and the second end configured to maintain a position on an external surface of the soft tissue with each of the first end and the second end configured to contact solely the soft tissue, and such that a tension from the shaft is configured exert an amount of pressure sufficient to prevent deformation of at least a portion of the soft tissue to prevent obstruction in an airway of the patient when a tongue of the patient is relaxed during sleep but permit flexing of the patient'"'"'s tongue by not impairing normal movement of the patient'"'"'s tongue during speech and swallowing, the tissue retractor further configured for at least one of removal, reinsertion, or subsequent retensioning by adjustment of the device by the patient for effectiveness and comfort.

45. The device of claim 44 wherein both the first and the second end are configured to be positioned on an external surface of the soft tissue.

46. A method for treatment of at least one of snoring and sleep apnea in a patient that prevents a deformation of a mucosa covering a soft tissue located in an oral cavity or a pharynx of the patient, the method comprising:

a) inserting a flexible shaft into a tongue of the patient, a first end of the flexible shaft is connected at or near a base of the patient'"'"'s tongue, and a second end of the flexible shaft is connected at or near a frenulum of the patient;

b) positioning a retractor member at or near the first end adjacent the base of the patient'"'"'s tongue; and

c) positioning an anchor member at or near the second end adjacent the patient'"'"'s frenulum, forming a connected retractor member, flexible shaft, and anchor member,

wherein neither the retractor member nor the anchor member are configured to be tethered to bone, and the retractor member is positioned on an external surface of the patient'"'"'s tongue, and the flexible shaft, the retractor member and the anchor member interact such that a tension from the flexible shaft is configured to exert an amount of pressure sufficient to prevent deformation of an external surface of the soft tissue when the patient'"'"'s tongue is relaxed during sleep but permit flexing of the patient'"'"'s tongue by not impairing normal movement of the patient'"'"'s tongue during speech and swallowing,

the connected retractor member, flexible shaft, and anchor member further configured for at least one of removal, reinsertion, or subsequent retensioning by adjustment of the connected retractor member, flexible shaft, and anchor member by the patient for effectiveness and comfort.