Apparatus and methods for treating sleep apnea

• US 20040134491A1
• Filed: 07/22/2003
• Published: 07/15/2004
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Quiescence Medical, Inc.
• Original Assignee: Quiescence Medical, Inc.
• Inventors: Thompson, Christopher Paul, Pflueger, D. Russell
• Granted Patent: US 7,992,566 B2
• Time in Patent Office: Days
• US Class Current: 128/200.24
• CPC Class Codes: A61F 2/20 Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith tracheae, bronchi per se A61F2/04 ; tracheostomy tubes A61M16/0465
• CPC Class Codes: A61F 2/203 comprising an air passage from trachea to oesophagus or to pharynx; Artificial epiglottis
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: Y10S 602/902 Antisnoring or mouth closing devices
• CPC Class Codes: Y10S 623/902 Method of implanting

Abstract

An apparatus and method for treating sleep apnea and/or snoring is provided. The apparatus includes an appliance sized and structured to be placed in the pharyngeal region of a human or animal and being effective in treating sleep apnea and/or snoring, for example in maintaining openness of an oropharyngeal region of a human or animal during natural sleep, advantageously while not interfering with normal functioning of the epiglottis. Preferably, the appliance is non-circumferential in form and includes rounded, spaced apart end portions.

Claims

1. An apparatus for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region and an epiglottis, the apparatus comprising:

an appliance sized and structured to be placed in a given position in the oropharyngeal region, other than to facilitate a surgical procedure, and being effective in treating at least one of sleep apnea and snoring, the appliance being further effective, when so placed, to provide at least one additional benefit relative to a device sized and structured for placement in a position in a human or animal other than in the given position in the oropharyngeal region when the device is placed in the given position in the oropharyngeal region.

2. The apparatus of claim 1 wherein the appliance is sized so that, when so placed in the given position in the oropharyngeal region, the appliance is located substantially entirely in the oropharyngeal region.

3. The apparatus of claim 1 wherein the at least one benefit comprises an enhanced compliance of the appliance with the functioning of at least one of the oropharyngeal region and the epiglottis.

4. The apparatus of claim 1 wherein the at least one benefit comprises an enhanced ability of the appliance to do at least one of provide support against collapse of the oropharyngeal region during sleep, and allow closure of an airway in the oropharyngeal region during swallowing.

5. The apparatus of claim 1 wherein the at least one benefit comprises an enhanced ability of the appliance to be tolerated by the human or animal in the given position.

6. The apparatus of claim 1 wherein the appliance has an effective non-constrained diameter of at least about 32 mm.

7. The apparatus of claim 1 wherein the appliance comprises a member defining a substantially C-shaped configuration.

8. The apparatus of claim 1 wherein the appliance, when located outside a human or animal, comprises a substantially flat member.

9. The apparatus of claim 1 wherein the appliance is sized and structured to permit substantially natural movement of the epiglottis when the appliance is located in the given position in the oropharyngeal region of the human or animal.

10. The apparatus of claim 1 wherein the appliance includes spaced apart, radiused end portions.

11. The apparatus of claim 1 wherein the appliance includes end portions and is further sized and structured, when the appliance is located in the given position, to be positioned against a portion of a posterior wall of the oropharyngeal region with the end portions being spaced apart anteriorly of the posterior wall.

12. The apparatus of claim 1 wherein the appliance comprises a member having a substantially elliptical configuration.

13. The apparatus of claim 1 wherein the appliance comprises a super-elastic material.

14. The apparatus of claim 1 wherein the appliance comprises Nitinol.

15. The apparatus of claim 1 wherein the appliance includes spaced apart end portions and a length defined between the end portions, and the appliance comprises a plurality of struts extending along at least a substantial portion of the length.

16. The apparatus of claim 1 wherein the appliance comprises a cuff-shaped member.

17. The apparatus of claim 16 wherein the cuff-shaped member includes spaced apart end portions.

18. The apparatus of claim 17 wherein the cuff-shaped member is sized and structured to be positioned against a portion of a posterior wall of the oropharyngeal region with the end portions spaced apart by a portion of an anterior wall of the oropharyngeal region.

19. An apparatus for treating a human or animal having a pharyngeal region, the apparatus comprising:

an appliance sized and structured to be placed, at least partially submucosally, within the pharyngeal region of the human or animal and to be effective, when so placed, to maintain patency of the pharyngeal region during natural sleep of the human or animal.

20. The apparatus of claim 19 wherein the appliance is structured to be effective in treating at least one of sleep apnea and snoring.

21. The apparatus of claim 19 wherein the appliance is structured to be effective in treating sleep apnea.

22. The apparatus of claim 19 wherein the appliance is structured to be placed in an oropharyngeal region.

23. The apparatus of claim 19 wherein the appliance is sized to be placed at least partially circumscribing an interior hollow passage defined by the pharyngeal region.

24. The apparatus of claim 19 wherein the appliance is sized to be placed at least partially circumscribing an interior hollow passage defined by an oropharyngeal region.

25. The apparatus of claim 19 wherein the appliance is sized to be placed circumscribing an interior hollow passage defined by the pharyngeal region.

26. The apparatus of claim 19 wherein the appliance is sized to be placed circumscribing, at least once, an interior hollow passage defined by the pharyngeal region.

27. The apparatus of claim 19 wherein the appliance comprises at least one elongated element.

28. The apparatus of claim 19 wherein the appliance comprises a single elongated element.

29. The apparatus of claim 19 wherein the appliance comprises at least one elongated element having a polygonal cross-section.

30. The apparatus of claim 19 wherein the appliance comprises at least one elongated element having a rounded cross-section.

31. The apparatus of claim 19 wherein the appliance is structured to be substantially entirely submucosally placed within the pharyngeal region.

32. The apparatus of claim 19 wherein the pharyngeal region has right and left lateral walls, and the appliance is structured to be implanted, at least partially submucosally, within the pharyngeal region, such that the appliance at least partially traverses the right and left lateral walls.

33. The apparatus of claim 19 wherein the pharyngeal region has right and left lateral walls, and the appliance is structured to be implanted, substantially entirely submucosally, within the pharyngeal region, such that the appliance at least partially traverses the right and left lateral walls.

34. The apparatus of claim 19 wherein the appliance comprises a super-elastic material.

35. The apparatus of claim 19 wherein the appliance comprises Nitinol.

38. The apparatus of claim 34 wherein the appliance is structured to be substantially entirely submucosally placed in the oropharyngeal region.

36. An apparatus for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region and an epiglottis, the apparatus comprising:

an appliance sized and structured to be placed in a position in the oropharyngeal region in proximity to the epiglottis, other than to facilitate a surgical procedure, and to be effective in treating at least one of sleep apnea and snoring.

37. The apparatus of claim 36 wherein the appliance is structured to be at least partially submucosally placed in the oropharyngeal region.

39. The apparatus of claim 36 wherein the appliance includes a magnetic component.

40. The apparatus of claim 36 wherein the appliance is structured to cause tissue stiffening when the appliance is placed in the position in the oropharyngeal region.

41. The apparatus of claim 36 wherein the oropharyngeal region has lateral walls and the appliance is structured, when so placed in the position, to support lateral walls of the oropharyngeal region against collapse during natural sleep, and to allow closure of an airway in the oropharyngeal region during swallowing.

42. The apparatus of claim 36 wherein the appliance comprises a member defining a substantially C-shaped configuration.

43. The apparatus of claim 36 wherein the appliance, when located outside a human or animal, comprises a substantially flat member.

44. The apparatus of claim 36 wherein the appliance is sized to permit substantially natural movement of the epiglottis when the apparatus is located in the position.

45. The apparatus of claim 36 wherein the appliance includes spaced apart, radiused end portions.

46. The apparatus of claim 36 wherein the appliance includes spaced apart end portions and is further sized and structured to be positioned against a portion of a posterior wall of the oropharyngeal region with the end portions spaced apart by a portion of an anterior wall of the oropharyngeal region.

47. The apparatus of claim 36 wherein the appliance has a resiliency and flexibility to allow natural functioning of the oropharyngeal region during swallowing and a hoop strength effective to support the oropharyngeal region against collapse during natural sleep.

48. The apparatus of claim 36 wherein the appliance comprises a super-elastic material.

49. The apparatus of claim 36 wherein the appliance comprises Nitinol.

50. An apparatus for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region including lateral walls and an epiglottis, the apparatus comprising:

an appliance sized and structured to be placed in a position in the oropharyngeal region in proximity to the epiglottis, other than to facilitate a surgical procedure, and being effective in treating at least one of sleep apnea and snoring, the appliance being structured, when placed in the position in the oropharyngeal region, to support the lateral walls of the oropharyngeal region against collapse during the time the human or animal is naturally sleeping.

51. The apparatus of claim 50 wherein the appliance is sized so that, when placed in the position in the oropharyngeal region, the appliance is located substantially entirely in the oropharyngeal region.

55. The method of claim 50 wherein the step of providing includes inserting the appliance into the oropharyngeal region through a mouth of the person or animal.

52. A method for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region, a valecullar space and an epiglottis, the method comprising:

providing an appliance in the oropharyngeal region of the human or animal, the appliance located in the oropharyngeal region being effective in treating at least one of sleep apnea and snoring during natural sleep of the human or animal.

53. The method of claim 52 wherein the appliance, when located in the oropharyngeal region, is effective in maintaining patency of the oropharyngeal region during natural sleep of the human or animal without causing substantial interference with at least one natural function of the epiglottis.

54. The method of claim 52 wherein the step of providing includes inserting the appliance into the oropharyngeal region while the appliance is in a first configuration and allowing the appliance to reconfigure to a second configuration within or in proximity to the oropharyngeal region.

56. An apparatus for maintaining patency of a human or animal oropharyngeal region having lateral walls, in order to control at least one of sleep apnea and snoring, the apparatus comprising:

an appliance comprising a body portion and end portions spaced apart by the body portion,

the appliance being structured to take on a deployed configuration when located within the oropharyngeal region, such that the end portions are spaced apart from each other anteriorly of a posterior wall of the oropharyngeal region, and

the appliance being further structured to exert a force on the lateral walls of the oropharyngeal region, when the appliance is in the deployed configuration within the oropharyngeal region, in order to cause the oropharyngeal region to be maintained substantially unobstructed.

57. The apparatus of claim 56 wherein the end portions are coupled together only through the body portion.

58. The apparatus of claim 56 wherein the appliance is structured to form a relatively flat configuration when the appliance is at rest outside the human or animal.

59. A method for maintaining patency of a pharyngeal region of a human or an animal during natural sleep, the method comprising the steps of:

providing a member in a substantially flat or precurved configuration, the member having a body portion and end portions spaced apart by the body portion; and

implanting the member, at least partially submucosally, within the pharyngeal region.

60. The method of claim 59 wherein the pharyngeal region has right and left lateral walls, and the member is effective to provide a substantially constant force against at least a portion of each of the right and left lateral walls.

61. The method of claim 59 wherein the step of implanting comprises implanting the member into pharyngeal region such that the member is substantially entirely submucosally implanted in the pharyngeal region.

62. A method for maintaining patency of a pharyngeal region of a human or an animal during natural sleep and for purposes other than surgery, the method comprising the steps of:

causing a tissue reaction of a pharyngeal region of a human or animal patient, said tissue reaction being effective in at least one of strengthening and stiffening lateral walls of the pharyngeal region.

63. The method of claim 62 wherein the step of causing a tissue reaction comprises applying an active agent to the lateral walls.

64. The method of claim 62 wherein the step of causing a tissue reaction comprises placing at least one member into the lateral walls.

65. A method for maintaining patency or causing to become patent, open or unobstructed, an pharyngeal region of a human or an animal during natural sleep and for purposes other than surgery, the method comprising the steps of:

suturing portions of the pharyngeal region of a human or animal, said suturing being effective in at least one of strengthening and stiffening lateral walls of the pharyngeal region.