Apparatus and methods for treating sleep apnea

• US 8,939,145 B2
• Filed: 08/05/2011
• Issued: 01/27/2015
• 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): Bianco, Patricia
• Assistant Examiner(s): PATEL, TARLA R
• Application Number:
  US13/204,623
• Publication Number:
  US 20110290258A1
• Time in Patent Office: 1,271 Days
• Field of Search: 128/846, 128/848, 128/858, 128/206.11, 128/207.18, 128/206.12, 128/206.18, 128/206.27, 128/207.13, 606/199, 606/204, 606/204.45, 606/108, 623/1.14, 623/1.15, 623/1.18, 623/1.19, 623/1.21, 623/1.22, 623/9, 623/14.11, 623/13.13, 600/529, 602/902
• 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, the apparatus comprising:

an appliance comprising a body portion including end portions spaced apart from one another to define a length of the appliance therebetween, the appliance having a substantially flat configuration defining a plane when the appliance is at rest and deployable in a curved configuration when the end portions are folded or rolled towards one another out of the plane, the appliance configured to return towards the substantially flat configuration to exert a force on the walls of the oropharyngeal region when deployed therein in the curved configuration; and

one or more elements extending from the body portion to enhance secure attachment of the appliance to the posterior wall of the oropharyngeal region,

wherein the one or more elements comprises struts including tips that extend out of the plane when the appliance is at rest in the substantially flat configuration.

2. The apparatus of claim 1, wherein the struts comprise a pair of opposing barbed portions.

3. The apparatus of claim 1, wherein the one or more elements comprises struts shaped as wave forms or s-shapes.

4. The apparatus of claim 1, wherein the appliance defines a substantially rectangular form.

5. The apparatus of claim 1, wherein the appliance defines one of a substantially oblong, oval, or elliptical form.

6. The apparatus of claim 1, wherein the end portions define a height of the appliance, and wherein the length is between about 50 and 90 mm and the height is between about 15 and 25 mm.

7. The apparatus of claim 1, wherein the appliance defines a “

C”

shape in the curved configuration.

8. The apparatus of claim 1, wherein the appliance and one or more elements are formed entirely from a unitary flat sheet of material that is laser cut or etched into the desired configuration.

9. The apparatus of claim 1, wherein the appliance comprises super-elastic material.

10. The apparatus of claim 1, wherein the appliance comprises a nickel titanium alloy.

11. The apparatus of claim 1, wherein the appliance is structured to have relatively atraumatic surfaces.

12. The apparatus of claim 1, wherein the end portions are curved.

13. The apparatus of claim 1, 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.

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

an appliance comprising a body portion including end portions spaced apart from one another to define a length of the appliance therebetween, the appliance having a substantially flat configuration defining a plane when the appliance is at rest and deployable in a curved configuration when the end portions are folded or rolled towards one another out of the plane, the appliance configured to return towards the substantially flat configuration to exert a force on the walls of the oropharyngeal region when deployed therein in the curved configuration; and

one or more elements extending from the body portion to enhance secure attachment of the appliance to the posterior wall of the oropharyngeal region,

wherein the appliance is sized and structured such that, when the appliance is positioned against a posterior wall of the oropharyngeal region in the curved configuration, the end portions are spaced apart anteriorly of the posterior wall.

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

an appliance comprising a body portion including end portions spaced apart from one another to define a length of the appliance therebetween, the appliance having a substantially flat configuration defining a plane when the appliance is at rest and deployable in a curved configuration when the end portions are folded or rolled towards one another out of the plane, the appliance configured to return towards the substantially flat configuration to exert a force on the walls of the oropharyngeal region when deployed therein in the curved configuration; and

one or more elements extending from the body portion to enhance secure attachment of the appliance to the posterior wall of the oropharyngeal region,

wherein the body portion comprises a plurality of wire or ribbon struts extending along a substantial portion of the length of the appliance.

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

an appliance comprising a body portion including end portions spaced apart from one another to define a length of the appliance therebetween, the appliance having a substantially flat configuration defining a plane when the appliance is at rest and deployable in a curved configuration when the end portions are folded or rolled towards one another out of the plane, the appliance configured to return towards the substantially flat configuration to exert a force on the walls of the oropharyngeal region when deployed therein in the curved configuration; and

one or more elements extending from the body portion to enhance secure attachment of the appliance to the posterior wall of the oropharyngeal region,

wherein the body portion and end portions define one or more open interior spaces, and wherein the one or more elements extend at least partially into the one or more interior spaces.

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

an appliance comprising a body portion including end portions spaced apart from one another to define a length of the appliance therebetween, the appliance having a substantially flat configuration defining a plane when the appliance is at rest and deployable in a curved configuration when the end portions are folded or rolled towards one another out of the plane, the appliance configured to return towards the substantially flat configuration to exert a force on the walls of the oropharyngeal region when deployed therein in the curved configuration; and

a plurality of struts extending from the body portion to enhance secure attachment of the appliance to the posterior wall of the oropharyngeal region.

18. The apparatus of claim 17, wherein the struts include tips that extend out of the plane when the appliance is at rest in the substantially flat configuration.

19. The apparatus of claim 17, wherein the struts comprise a pair of opposing barbed portions.

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

providing an appliance comprising a body portion including end portions spaced apart from one another;

rolling or folding the end portions towards one another to direct the appliance into a curved configuration;

introducing the appliance into an oropharyngeal region;

releasing the appliance within the oropharyngeal region in the curved configuration such that the appliance extends generally laterally across the posterior wall and the end portions bear against and provide an opening force against lateral walls of the oropharyngeal region; and

anchoring the appliance within the oropharyngeal region using one or more elements extending from a central region of the appliance into the posterior wall of the oropharyngeal region.

21. The method of claim 20, wherein the appliance has a substantially flat configuration defining a plane when the appliance is at rest, the appliance configured to return towards the substantially flat configuration to exert a force on the walls of the oropharyngeal region when deployed therein in the curved configuration.

22. The method of claim 20, wherein the one or more elements comprise barbed portions that securely attach the appliance to the posterior wall of the oropharyngeal region.

23. The method of claim 20, wherein, when the appliance is released within the oropharyngeal region in the curved configuration, the end portions define a gap therebetween adjacent an anterior wall of the oropharyngeal region.

24. The method of claim 20, wherein, when the appliance is released within the oropharyngeal region in the curved configuration, the end portions at least partially overlap adjacent an anterior wall of the oropharyngeal region.

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

providing an appliance comprising a body portion including end portions spaced apart from one another; and

securing the appliance within an oropharyngeal region using one or more struts thereon such that the appliance extends generally laterally across the posterior wall and the end portions bear against and provide an opening force against lateral walls of the oropharyngeal region.

26. The method of claim 25, wherein the one or more struts comprise barbed portions that securely attach the appliance to the posterior wall of the oropharyngeal region.

27. The method of claim 25, wherein the appliance is secured within the oropharyngeal region in a curved configuration, and wherein the appliance has a substantially flat configuration defining a plane when the appliance is at rest, the appliance configured to return towards the substantially flat configuration to exert a force on the walls of the oropharyngeal region in the curved configuration.