Apparatus and methods for treating sleep apnea

• US 7,992,566 B2
• Filed: 07/22/2003
• Issued: 08/09/2011
• Est. Priority Date: 12/30/2002
• Status: Expired due to Fees

• Current Assignee: Quiescence Medical, Inc.
• Original Assignee: Quiescence Medical, Inc.
• Inventors: Thompson, Christopher Paul, Pflueger, D. Russell
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): PATEL, NIHIR B
• Application Number:
  US10/624,915
• Publication Number:
  US 20040134491A1
• Time in Patent Office: 2,940 Days
• Field of Search: 128/848, 128/898, 128/897, 128/200.24, 128/201.26, 128/206.29, 128859-861, 128/200.26, 606/196, 606/198, 623/9, 623/23.64, 623/23.7, 623/902
• US Class Current: 128/848
• 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 methods for treating sleep apnea and/or snoring are provided. The apparatus includes an appliance sized and structured to be placed in the pharyngeal region of a human or animal. The appliance, when so placed is 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. Preferably, the appliance is non-circumferential in form and includes rounded, spaced apart end portions.

Claims

1. A method for treating sleep apnea in a human or an animal having an oropharyngeal region with lateral and posterior walls, a soft palate, a valecullar space and an epiglottis, the method comprising:

providing an appliance made of a biocompatible metal below a soft palate of a human or animal in or radially outwardly from the lateral and posterior walls of an oropharyngeal region of the human or animal, the appliance so provided having at least two laterally positioned elements substantially longitudinally spaced apart from each other to define an open interior space therebetween and providing an opening force against the lateral walls of the oropharyngeal region,

wherein the appliance comprises resilient wire.

2. The method of claim 1 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.

3. The method of claim 1 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.

4. The method of claim 1 wherein the step of providing includes inserting the appliance into the oropharyngeal region through a mouth of the person or animal.

5. The method of claim 1 wherein the providing step includes placing the appliance at least partially in or beneath the mucosal layer of the lateral and posterior walls of the oropharyngeal region.

6. The method of claim 1 wherein the providing step includes placing the appliance completely across the posterior wall of the oropharyngeal region.

7. The method of claim 1 wherein the providing step includes providing the appliance in a deformed first configuration, inserting the appliance into the oropharyngeal region and allowing the appliance to reconfigure to a deployed second configuration within the oropharyngeal region.

8. The method of claim 1 wherein the appliance, when so provided, has at least one of the elements extending across the posterior wall of the oropharyngeal region.

9. The method of claim 1 wherein the at least two elements are coupled together.

10. The method of claim 1 wherein the at least two elements are portions of the same structure.

11. The method of claim 1 wherein the appliance has a lateral dimension and a longitudinal dimension perpendicular to the lateral dimension which is less than the lateral dimension when the appliance is so provided.

12. The method of claim 1 wherein the appliance is sized and structured so that each of the at least two elements extend across the posterior wall and at least a portion of one of the lateral walls when the appliance is so provided.

13. The method of claim 1 wherein the appliance is sized and structured so that the at least two elements extend across the posterior wall and at least a portion of both the lateral walls when the appliance is so provided.

14. The method of claim 1 wherein the appliance has an open concave loop configuration when so provided.

15. The method of claim 1 wherein the appliance is made of an elastic spring memory material.

16. The method of claim 1 wherein the appliance is made of nitinol.

17. A method of claim 1 for treating sleep apnea in a human or an animal having an oropharyngeal region with lateral and posterior walls, a soft palate, a valecullar space and an epiglottis, the method comprising:

providing an appliance made of a biocompatible metal below a soft palate of a human or animal in or radially outwardly from the lateral and posterior walls of an oropharyngeal region of the human or animal, the appliance so provided having at least two laterally positioned elements substantially longitudinally spaced apart from each other to define an open interior space therebetween and providing an opening force against the lateral walls of the oropharyngeal region,

wherein the appliance, when so provided, is effective to support or reinforce the oropharyngeal region without reacting with tissue in the oropharyngeal region.

18. An apparatus for treating sleep apnea in a human or animal having an oropharyngeal region with lateral and posterior walls, the apparatus comprising:

an appliance comprising two elongated curved elements made of a bio compatible metal, each of the curved elements having a substantially circular dimension between a first end and a second end extending through more than 90°

of a circle, the two elements being coupled together at respective first and second ends, and being spaced apart from each other between the first and second ends to define an open interior space therebetween, the appliance being sized and structured to be placed in or radially outwardly from the lateral and posterior walls of an oropharyngeal region of a human or animal with the length of at least one of the elongated elements extending generally laterally across the posterior wall and, when so placed, being effective in treating sleep apnea,

wherein the appliance includes only two elongated curved elements, each of the curved elements has a curved length extending from the first end to the second end, and the first end and the second end define a gap therebetween extending outwardly away from the first and second curved elements having a gap length which is reduced relative to the curved length of each of the curved elements.

19. The apparatus of claim 18 wherein the substantially circular dimension between the first and the second ends extends through at least 180°

of a circle.

20. The apparatus of claim 18 wherein each of the two elongated elements comprises a resilient wire.

21. The apparatus of claim 18 wherein the appliance comprises a C-shaped structure.

22. The apparatus of claim 18 wherein the two elongated elements are portions of the same structure.

23. The apparatus of claim 18 wherein the appliance has a lateral dimension defined by the distance between the first and second ends and a maximum longitudinal dimension perpendicular to the lateral dimension which is less than the lateral dimension.

24. The apparatus of claim 18 wherein the appliance has a concave loop configuration when the appliance is so placed in the oropharyngeal region.

25. The apparatus of claim 18 wherein the appliance is sized and structured to be placed below a soft palate of a human or animal.

26. The apparatus of claim 18 wherein the appliance is made of an elastic spring memory material.

27. The apparatus of claim 18 wherein the appliance is made of nitinol.

28. An apparatus for treating at least one of sleep apnea and snoring, comprising:

an appliance comprising an elongated loop comprising first and second end portions and two spaced apart elongated elements extending between the first and second end portions, the appliance being sized for introduction into an oropharyngeal region of a human or animal and deployable in a C-shaped deployed configuration in which at least one of the elongated elements extends generally laterally across the posterior wall and the first and second end portions bear against and provide an opening force against the lateral walls of the oropharyngeal region,

wherein, in the substantially C-shaped configuration, the first and second end portions define a gap therebetween.

29. The apparatus of claim 28, wherein the appliance defines an open interior space between the spaced apart elongated elements.

30. The apparatus of claim 29, further comprising a plurality of struts extending across the open interior space.

31. The apparatus of claim 28, wherein the elongate loop comprises a substantially mesh structure.

32. The apparatus of claim 28, wherein the appliance expands to a diameter greater than 32 mm in the deployed configuration.

33. The apparatus of claim 28, wherein the appliance comprises biocompatible metal.

34. A method for treating at least one of sleep apnea and snoring, comprising:

providing an appliance comprising a continuous loop comprising first and second end portions and two spaced apart elongated elements extending between the first and second end portions;

introducing the appliance into an oropharyngeal region; and

releasing the appliance within the oropharyngeal region such that the elongated elements extends generally laterally across the posterior wall and the first and second end portions bear against and provide an opening force against the lateral walls of the oropharyngeal region,

wherein the appliance comprises a substantially C-shaped configuration with the first and second end portions defining a gap therebetween when released within the oropharyngeal region.

35. The method of claim 34 wherein introducing the appliance comprises placing the appliance at least partially in or beneath the mucosal layer of the oropharyngeal region.

36. The method of claim 34, wherein introducing the appliance comprises providing the appliance in a deformed first configuration, and wherein releasing the appliance within the oropharyngeal region allows the appliance to reconfigure to a deployed second configuration within the oropharyngeal region.

37. The method of claim 36, wherein the deployed second configuration comprises a C-shaped configuration.

38. The method of claim 34, wherein the appliance comprises biocompatible metal.