Methods and Devices for Treating Sleep Apnea

• US 20110230727A1
• Filed: 10/16/2009
• Published: 09/22/2011
• Est. Priority Date: 10/16/2008
• Status: Active Grant

• Current Assignee: LinguaFlex, Inc.
• Original Assignee: LinguaFlex, Inc.
• Inventors: Sanders, Ira, Dwyer, Cliff
• Granted Patent: US 9,925,086 B2
• Time in Patent Office: Days
• US Class Current: 600/237
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

An implantable tissue retractor for treatment of a breathing disorder and related methods. The implantable tissue retractor comprises a shaft sized for insertion into a soft tissue located in a patient'"'"'s oral cavity or pharynx. The implantable tissue retractor also comprises a retractor member at or near a first end of the shaft. The implantable tissue retractor also comprises a removable coupler connected at or near a second end of the shaft. At least one of a portion of the shaft or the retractor member is positionable on a surface of the soft tissue. At least one of the shaft, retractor member, or removable coupler is adjustable to vary a force to prevent a deformation of at least a portion of the soft tissue to prevent obstruction of the patient'"'"'s airway.

Claims

1. An implantable tissue retractor for treatment of a breathing disorder, the implantable tissue retractor comprising:

a shaft sized for insertion into a soft tissue located in a patient'"'"'s oral cavity or pharynx;

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

a removable coupler connected at or near a second end of the shaft;

wherein at least one of a portion of the shaft or the retractor member is positionable on a surface of the soft tissue, and at least one of the shaft, retractor member, or removable coupler is adjustable to vary a force to prevent a deformation of at least a portion of the soft tissue to prevent obstruction of the patient'"'"'s airway.

2. The implantable tissue retractor of claim 1 wherein the removable coupler comprises a suture, a magnet, a vacuum, an adhesive, a screw, or a hook.

3. The implantable tissue retractor of claim 1 wherein the shaft has at least one securing feature.

4. The implantable tissue retractor of claim 3 wherein the securing feature comprises a protuberance.

5. The implantable tissue retractor of claim 3 wherein the securing feature comprises a cavity.

6. The implantable tissue retractor of claim 3 wherein the securing feature comprises an aperture.

7. The implantable tissue retractor of claim 3 wherein the securing feature is integrally formed with the shaft.

8. The implantable tissue retractor of claim 1 wherein the shaft is flexible.

9. The implantable tissue retractor of claim 1 further comprising an anchor member.

10. The implantable tissue retractor of claim 9 wherein the anchor member comprises a locking member and a pad.

11. The implantable tissue retractor of claim 10 wherein the pad has a recess, the recess capable of receiving the locking member or the anchor member.

12. The implantable tissue retractor of claim 10 wherein the pad is curved, the pad capable of contacting the soft tissues located in the patient'"'"'s oral cavity or pharynx and distributing force across the soft tissue.

13. The implantable tissue retractor of claim 10 wherein the pad is adapted to be removed from the shaft without removing the locking member from the shaft.

14. The implantable tissue retractor of claim 1 wherein the retractor member is disc shaped, rod shaped, triangularly shaped, cross-rod shaped, saddle shaped, half-saddle shaped, oval shaped, or rectangularly shaped.

15. The implantable tissue retractor of claim 1 wherein the retractor member is off center along at least one axis.

16. The implantable tissue retractor of claim 1 wherein the shaft has a first end and a second end, the first end having a first thickness, an intermediate portion located between the first end and the second end, the intermediate portion having a second thickness.

17. The implantable tissue retractor of claim 16 wherein the first thickness is greater than the second thickness.

18. The implantable tissue retractor of claim 17 wherein the intermediate portion is located at or near the removable coupler.

19. The implantable tissue retractor of claim 1 wherein the shaft has a thickness of about 0.1 millimeters to about 5 millimeters.

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

a shaft sized for insertion into a soft tissue located in a patient'"'"'s oral cavity or pharynx, the shaft having at least one securing feature;

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

an anchor member engagable by the at least one securing feature;

wherein at least one of the shaft, the retractor member or the anchor member is positionable on a surface of the soft tissue, and at least one of the shaft, the retractor member, or the anchor member is adjustable to vary a force that prevents a deformation of at least a portion of the soft tissue to prevent obstruction of the patient'"'"'s airway.

21. The tissue retractor of claim 20 wherein the anchor member comprises a locking member and a pad, the pad configured to distribute a force across the soft tissue.

22. The tissue retractor of claim 21 wherein the pad has a recess, the recess capable of receiving the locking member.

23. The tissue retractor of claim 20 wherein the securing feature is a protuberance.

24. The tissue retractor of claim 20 wherein the securing feature is a cavity.

25. The tissue retractor of claim 20 wherein the securing feature is an aperture.

26. The tissue retractor of claim 20 wherein the locking member is a slide lock or a clamshell lock.

27. The implantable tissue retractor of claim 20 wherein the retractor member is disc shaped, rod shaped, triangularly shaped, cross-rod shaped, saddle shaped, half-saddle shaped, oval shaped, or rectangularly shaped.

28. The implantable tissue retractor of claim 20 wherein the shaft has a first end and a second end, the first end having a first thickness, an intermediate portion located between the first end and the second end, the intermediate portion having a second thickness, the second thickness less than the first thickness, a junction where the first thickness meets the second thickness.

29. The implantable tissue retractor of claim 28 wherein the junction is located at or near the anchor member.

30. A tissue retractor holder for implantation of a tissue retractor, the tissue retractor holder comprising:

a handle;

a retainer disposed at a distal end of the handle for releasably retaining a removable coupler; and

a detainer positioned along the handle, the detainer for releasably engaging an implantable tissue retractor;

wherein the retainer is adapted to provide a force to a soft tissue of a patient'"'"'s oral cavity, the force preventing deformation of the soft tissue when an implantation device is inserted into an opposite side of the soft tissue.

31. The tissue retractor holder of claim 30 wherein the retainer comprises:

a first forked arm extending from the distal end of the handle; and

a second forked arm extending from the distal end of the handle.

32. The tissue retractor holder of claim 31 wherein a distal end of the first forked arm is connected to a distal end of the second forked arm forming a continuous surface.

33. The tissue retractor holder of claim 30 wherein the detainer comprises at least one of a groove, a clamp or a clip.

34. The tissue retractor holder of claim 30 further comprising a guard disposed at or near the retainer, the guard configured to impede an excessive progression of an implantation device.

35. The tissue retractor holder of claim 30 wherein the handle is curved at or near where the handle and the retainer are joined.

36. An implantation device for insertion of a tissue retractor, the implantation device comprising:

a shaft having a pointed end and a second end;

a first mechanical coupler near the pointed end of the shaft, the first mechanical coupler adapted to couple with a removable coupler of the tissue retractor; and

a handle at the second end.

37. The implantation device of claim 36 wherein the first mechanical coupler comprises a cleft.

38. The implantation device of claim 36 wherein the first mechanical coupler comprises a suture, a magnet, a vacuum, an adhesive, a screw, or a hook.

39. The implantation device of claim 36 wherein the removable coupler of the tissue retractor comprises a suture, a magnet, a vacuum, an adhesive, a screw, or a hook.

40. The implantation device of claim 36 further comprising a releasable locking member located at or near the first mechanical coupler.

41. The implantation device of claim 40 wherein the releasable locking member is a sheath, the sheath sized to fit over the shaft and configured to hinder an unintentional disengagement of a removable coupler of an implantable tissue retractor.

42. The implantation device of claim 40 wherein the handle contains a tension meter, the tension meter capable of measuring the tension of a shaft of an implantable tissue retractor.

43. A kit for treatment of a breathing disorder, the kit comprising:

a implantable tissue retractor comprising a shaft sized for insertion into a soft tissue located in a patient'"'"'s oral cavity or pharynx, a retractor member disposed at or near a first end of the shaft, and a removable coupler connected at or near a second end of the shaft; and

a tissue retractor holder comprising a handle, a retention system disposed at a distal end of the handle for temporarily retaining the removable coupler, and a detainer positioned on the handle, the detainer capable of engaging the implantable tissue retractor.

44. The kit of claim 43 further comprising an implantation device comprising a shaft having a pointed end and a second end, a mechanical coupler near the pointed end of the shaft, the mechanical coupler adapted to couple with the removable coupler, and a handle at the second end.

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

a) inserting a tissue retractor implantation device into a first location of a soft tissue located in a patient'"'"'s oral cavity or pharynx, the tissue retractor implantation device including a mechanical coupler;

b) inserting a first implantable tissue retractor into the oral cavity or pharynx, the first implantable tissue retractor comprising a first shaft, a first retractor member connected at or near a first end of the first shaft, and a first removable coupler disposed at or near a second end of the first shaft;

c) engaging the first removable coupler with the mechanical coupler of the tissue retractor implantation device;

d) withdrawing the mechanical coupler of the tissue retractor implantation device to secure at least a portion of the first implantable tissue retractor within the soft tissue;

e) securing a first anchor member to the second end of the first shaft of the first implantable tissue retractor to secure the first implantable tissue retractor within the soft tissue; and

f) removing the first removable coupler.

46. The method of claim 45 further comprising establishing an amount of securing force against the soft tissue by adjusting a length of the first shaft between the first retractor member and the anchor member.

47. The method of claim 45 further comprising establishing an amount of securing force against the soft tissue by adjusting a physical characteristic of the first shaft between the first retractor member and the anchor member.

48. The method of claim 46 wherein the amount of securing force is about zero to about 1000 grams.

49. The method of claim 46 wherein the amount of securing force is about 5 to about 200 grams.

50. The method of claim 46 wherein the amount of securing force is about 10 to about 75 grams.

51. The method of claim 45 wherein step b comprises using a tissue retractor holder to insert the first implantable tissue retractor into the oral cavity or pharynx, the tissue retractor holder having a handle, a retainer disposed at a distal end of the handle, and a detainer positioned on the handle, the detainer capable of engaging the implantable tissue retractor.

52. The method of claim 45 further comprising:

g) inserting the tissue retractor implantation device into a second location of a soft tissue located in a patient'"'"'s oral cavity or pharynx, the tissue retractor implantation device including a mechanical coupler;

h) inserting a second implantable tissue retractor into the oral cavity or pharynx, the second implantable tissue retractor comprising a second shaft and a second removable coupler disposed at or near a second end of the second shaft;

i) engaging the second removable coupler;

j) withdrawing the mechanical coupler of the tissue retractor implantation device to secure at least a portion of the second implantable tissue retractor within the soft tissue;

k) securing a first end of the second implantable tissue retractor to the first retractor member of the first implantable tissue retractor;

l) securing a second anchor member to the second end of the second shaft of the second implantable tissue retractor to secure the second implantable tissue retractor within the soft tissue; and

m) removing the second removable coupler.

53. The method of claim 45 further comprising:

g) inserting a tissue retractor implantation device into a second location of a soft tissue located in a patient'"'"'s oral cavity or pharynx, the tissue retractor implantation device including a mechanical coupler;

h) inserting a second implantable tissue retractor into the oral cavity or pharynx, the second implantable tissue retractor comprising a second shaft, a second retractor member connected at or near a first end of the second shaft, and a second removable coupler disposed at or near a second end of the second shaft;

i) engaging the second removable coupler;

j) withdrawing the mechanical coupler of the tissue retractor implantation device to secure at least a portion of the second implantable tissue retractor within the soft tissue;

k) securing a second anchor member to the second end of the second shaft of the second implantable tissue retractor to secure the second implantable tissue retractor within the soft tissue; and

l) removing the second removable coupler.

54. A method of retensioning a tissue retractor, the method comprising:

locating a tissue retractor within a soft tissue of a patient, the tissue retractor having a retractor member located at or near a first end of a shaft and an anchor member located at or near a second end of the shaft;

loosening the anchor member;

establishing an amount of securing force against the soft tissue by adjusting a length of the shaft between the retractor member and the anchor member; and

resecuring the anchor member to the shaft of the tissue retractor.

55. The method of claim 54 wherein the resecuring step is performed using a second anchor member.

56. A method of replacing a tissue retractor, the method comprising:

locating a first tissue retractor within a soft tissue of a patient, the first tissue retractor having a first retractor member located at or near a first end of a first shaft and a first anchor member located at or near a second end of the first shaft;

removing the first anchor member;

extracting the first tissue retractor from the soft tissue of the patient, a conduit located where the first tissue retractor was extracted from the soft tissue of the patient;

implanting a second tissue retractor along the conduit of the soft tissue of the patient, the second tissue retractor having a second shaft and a second retractor member located at or near a first end of the second shaft;

establishing an amount of securing force against the soft tissue by adjusting a length of the second shaft; and

securing a second anchor member to the second shaft of the second tissue retractor.