Apparatus and methods for treating sleep apnea

• US 8,104,478 B2
• Filed: 12/30/2003
• Issued: 01/31/2012
• Est. Priority Date: 12/30/2002
• Status: Expired due to Fees

• Current Assignee: Quiescence Medical, Inc.
• Original Assignee: Quiescence Medical, Inc.
• Inventors: Pflueger, D. Russell, Thompson, Christopher Paul
• Primary Examiner(s): Yu, Justine
• Assistant Examiner(s): Ostrup, Clinton T
• Application Number:
  US10/541,255
• Publication Number:
  US 20060157055A1
• Time in Patent Office: 2,954 Days
• Field of Search: 128/848, 128/200.26, 128/200.24, 128/207.14, 128/859, 128/860, 128/861, 128/862, 128/863
• 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 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. The appliance may be made of a super elastic material, for example, Nitinol, and may be submucossally implanted in the pharyngeal walls.

Claims

1. A method for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region with lateral and posterior walls, the method comprising:

providing an appliance comprising at least one element having a length extending from a first end to a second end, wherein the at least one element is substantially bow shaped with the appliance at rest, the appliance comprising a central body portion between end portions adjacent the first and second ends;

inserting the appliance into an oropharyngeal region in a constrained configuration; and

releasing the appliance within the oropharyngeal region, thereby allowing the appliance to expand radially within the oropharyngeal region so that the central body portion extends generally laterally across the posterior wall and the end portions support the lateral walls of the oropharyngeal region.

2. The method of claim 1 wherein the appliance includes at least two elements coupled together at the first and second ends and spaced apart from each other.

3. The method of claim 2 wherein at least one of the at least two elements includes a region between the first and second ends substantially further spaced apart from the other of the at least two elements, thereby at least partially defining relatively wide end portions.

4. The method of claim 1 wherein the inserting step includes placing the appliance in or beneath the mucosal layer of the lateral and posterior walls of the oropharyngeal region.

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

6. The method of claim 1 wherein the inserting 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.

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

8. The method of claim 1, wherein the at least one element is pre-curved to a diameter larger than the oropharyngeal region, and wherein, in the constrained condition, the at least one element is sized for introduction into the oropharyngeal region.

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

introducing an appliance into an oropharyngeal region of a patient, the appliance comprising a transverse portion between end portions, the transverse portion being substantially bow shaped with the appliance at rest; and

securing the appliance within the oropharyngeal region such that the transverse portion extends along a posterior wall and at least partially around opposite lateral walls of the oropharyngeal region and the end portions support the tongue;

wherein introducing the appliance into the oropharyngeal region comprises;

inserting the appliance into the oropharyngeal region in a constrained configuration; and

expanding the appliance to a deployed configuration within the oropharyngeal region.

10. The method of claim 9, wherein the appliance is expanded by releasing the appliance, thereby allowing the appliance to resiliently expand radially within the oropharyngeal region.

11. The method of claim 9, wherein the appliance provides a substantially constant radial force against the lateral walls of the oropharyngeal region.

12. The method of claim 9, wherein the appliance provides a substantially constant radial force against the base of the tongue.

13. The method of claim 9, wherein the appliance is secured within the oropharyngeal region such that the end portions extend around opposite lateral walls of the oropharyngeal region and support the tongue.

14. The method of claim 13, wherein, upon contraction of the oropharyngeal region, the end portions are temporarily forced towards one another, the end portions biased to move away from one another to open the oropharyngeal region.

15. The method of claim 13, wherein the end portions push the tongue forward to hold the airway patent.

16. The method of claim 13, wherein the appliance extends around the airway such that the end portions traverse a base of the tongue.

17. The method of claim 9, wherein the appliance is secured to the oropharyngeal region by suturing the appliance to the pharyngeal region.

18. The method of claim 9, wherein the appliance is secured to the oropharyngeal region using an adhesive.

19. The method of claim 9, wherein the appliance is secured to the oropharyngeal region by implanting the appliance at least partially submucosally.

20. A method for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region with lateral and posterior walls, comprising:

providing an appliance comprising an element having a length extending along a transverse portion from a first end portion to a second end portion, the element being substantially bow shaped with the appliance at rest;

inserting the appliance into an oropharyngeal region in a constrained configuration; and

releasing the appliance within the oropharyngeal region, thereby allowing the appliance to expand radially within the oropharyngeal region so that the transverse portion extends generally laterally across the posterior wall and supports the lateral walls of the oropharyngeal region.

21. The method of claim 20, wherein the appliance is biased to resiliently expand radially within the oropharyngeal region when released.

22. The method of claim 20, wherein the appliance provides a substantially constant radial force against the lateral walls of the oropharyngeal region.

23. The method of claim 20, wherein the appliance provides a substantially constant radial force against the base of the tongue.

24. The method of claim 20, wherein the appliance is secured within the oropharyngeal region such that the end portions extend around opposite lateral walls of the oropharyngeal region and support the tongue.

25. The method of claim 24, wherein the end portions push the tongue forward to hold the airway patent.

26. The method of claim 24, wherein the appliance extends around the airway such that the end portions traverse a base of the tongue.

27. The method of claim 20, wherein the appliance includes two elements coupled together at the first and second end portions and spaced apart from each other such that the elements extend generally laterally across the posterior wall and support the lateral walls of the oropharyngeal region.

28. A method for maintaining the patency of an airway of a patient, comprising:

introducing an appliance into an oropharyngeal region of the patient, the appliance comprising a transverse portion between spaced apart end portions, the transverse portion being substantially bow shaped with the appliance at rest, the appliance having a length between the spaced apart end portions and a height transverse to the length, the length greater than the height; and

securing the appliance within the oropharyngeal region such that the transverse portion extends at least partially around the oropharyngeal region and the end portions push the tongue forward to hold the airway patent;

wherein introducing the appliance into the oropharyngeal region comprises;

inserting the appliance into the oropharyngeal region in a constrained configuration; and

expanding the appliance to a deployed configuration within the oropharyngeal region.

29. The method of claim 28, wherein securing the appliance comprises releasing the entire appliance within the oropharyngeal region.