Devices and methods for treating sleep disorders

• US 20060266369A1
• Filed: 05/23/2006
• Published: 11/30/2006
• Est. Priority Date: 05/27/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Prospex Medical, Inc. (Boston Scientific Corporation)
• Inventors: Kugler, Chad J., Atkinson, Robert E.
• Granted Patent: US 7,644,714 B2
• Time in Patent Office: Days
• US Class Current: 128/848
• CPC Class Codes: A61C 7/06 Extra-oral force transmitting means, i.e. means worn externally of the mouth and placing a member in the mouth under tension
• CPC Class Codes: A61C 7/08 Mouthpiece-type retainers or positioners, e.g. for both the lower and upper arch arch-shaped medicament applicators for teeth or gums A61C19/063; mouthguards for protecting the teeth of sportsmen A63B71/085
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: Y10S 602/902 Antisnoring or mouth closing devices

Abstract

Devices and methods for maintaining an open airway are described. Systems and methods are described for maintaining an opening of an airway by application of force to a patient'"'"'s tissues in one of inferior, anterior, and lateral directions.

Claims

1. A device for maintaining an open airway comprising:

a body portion configured for application along a front portion of a patient'"'"'s neck, the body portion having a perimeter, an outside surface, and an inside surface;

an adhesive provided along the inside surface such that the body portion is configured for adhesive engagement with the front portion of the patient'"'"'s neck; and

a traction application mechanism configured to apply traction in one or both of inferior and anterior directions to tissues in contact with the adhesive layer.

2. The device of claim 1, wherein the perimeter of the body portion is sized to cover an area extending from about a patient'"'"'s mandible up to about the patient'"'"'s clavicle.

3. The device of claim 1, wherein the traction application mechanism comprises an inflation device provided proximate the perimeter, wherein inflation of the inflatable device displaces the body portion and the adhesive in one or both of the inferior and anterior directions.

4. The device of claim 1, wherein the traction application mechanism is configured to apply traction in both inferior and anterior directions to tissues in contact with the adhesive.

5. The device of claim 1, wherein the traction application mechanism comprises a series of inflatable devices provided proximate the perimeter, wherein inflation of the inflatable devices displaces the body portion and the adhesive layer in one or both of the inferior and anterior directions.

6. The device of claim 1, further comprising:

a second body portion configured for application along a back portion of a patient'"'"'s neck, the second body portion having a perimeter, an outside surface, and an inside surface;

an adhesive provided along the inside surface of the second body portion such that the body portion is configured for adhesive engagement with the back portion of the patient'"'"'s neck; and

wherein the traction application mechanism interconnects the body portion configured for application along a front portion of a patient'"'"'s neck with the second body portion.

7. The device of claim 1, wherein the traction application mechanism comprises a resilient material of the body portion, the resilient material causing the body portion to have a first resting configuration and a second deformed configuration, such that upon application of the body portion along a front portion of a patient'"'"'s neck, the body portion attains the second configuration and applies traction in one or both of inferior and anterior directions to tissues in contact with the adhesive layer.

8. The device of claim 7, wherein the resilient material comprises a sheet metal.

9. The device of claim 7, wherein the resilient material imparts a convex shape to the inside surface of the body portion when the resilient material is in the first resting configuration.

10. The device of claim 9, wherein the resilient material imparts a concave shape to the inside surface of the body portion when the resilient material is in the second configuration.

11. The device of claim 7, wherein the resilient material imparts a substantially flat shape to the body portion when the body portion is in the first resting configuration.

12. The device of claim 11, wherein the resilient material imparts a concave shape to the inside surface of the body portion when the body portion is in the second configuration.

13. The device of claim 7, wherein the body portion is configured for application to the neck under a patient'"'"'s mandible such that upon attaining the second configuration, the body portion applies traction in an inferior direction to tissues in contact with the adhesive layer.

14. The device of claim 7, wherein the body portion is configured for application to the neck over a patient'"'"'s thyroid cartilage such that upon attaining the second configuration, the body portion applies traction in an anterior direction to tissues in contact with the adhesive layer.

15. A method of maintaining an open airway comprising:

providing a body portion having a perimeter, an outside surface, and an inside surface with an adhesive thereon;

providing a traction application mechanism to the body portion;

applying the inside surface to a front portion of a patient'"'"'s neck with the adhesive; and

applying traction in one or both of inferior and anterior directions to tissues in contact with the adhesive layer with the traction application mechanism.

16. The method of claim 15, wherein the front portion encompasses an area extending from about a patient'"'"'s mandible up to about the patient'"'"'s clavicle.

17. The method of claim 15, wherein providing a traction application mechanism comprises providing an inflation device proximate the perimeter, and wherein applying traction comprises inflating the inflatable device, thereby displacing the body portion and the adhesive in one or both of the inferior and anterior directions.

18. The method of claim 15, wherein applying traction comprises applying traction in both inferior and anterior directions to tissues in contact with the adhesive.

19. The method of claim 15, wherein providing a traction application mechanism comprises providing a series of inflatable devices proximate the perimeter, and wherein applying traction comprises inflating the inflatable devices, thereby displacing the body portion and the adhesive layer in one or both of the inferior and anterior directions.

20. The method of claim 15, further comprising:

providing a second body portion along a back portion of a patient'"'"'s neck, the second body portion having a perimeter, an outside surface, and an inside surface with an adhesive thereon; and

interconnecting the second body portion with the body portion applied to a front portion of the patient'"'"'s neck, with the traction application mechanism.

21. A method of maintaining an open airway comprising:

providing a first tension member and a second tension member, each tension member having a first end and a second end;

securing a first end of each tension member to a patient'"'"'s hyoid bone; and

securing a second end of each tension member to surrounding anatomical structure such that the tension members pull the hyoid bone in anterior and inferior directions, thereby increasing a luminal size of the airway.

22. The method of claim 21, wherein at least one of the first and second tension members pull the hyoid bone in a lateral direction.

23. The method of claim 21, wherein the second end of the first tension member is secured to the chin, and the second end of the second tension member is secured to the sternum.

24. The method of claim 21, wherein the second end of the first tension member is secured to the chin, and the second end of the second tension member is secured to a clavicle.

25. The method of claim 24, wherein the second end of the second tension member is secured to a right clavicle, and a third tension member is provided having a first end secured to the hyoid bone and a second end secured to a left clavicle.

26. The method of claim 21, wherein the second end of the first tension member is secured to a left lateral portion of the chin, a second end of the second tension member is secured to a right clavicle, a third tension member is provided having a first end secured to the hyoid bone and a second end secured to a left clavicle, and a fourth tension member is provided having a first end secured to the hyoid bone and a second end secured to a right lateral portion of the chin.

27. The method of claim 21, wherein the second end of the first tension member is secured to a middle portion of the chin, a second end of the second tension member is secured to a left lateral portion of the thyroid cartilage, and a third tension member is provided having a first end secured to the hyoid bone and a second end secured to a right lateral portion of the thyroid cartilage.

28. The method of claim 21, wherein securing the first and second ends of each tension member comprises creating an incision proximate an anatomical attachment point, threading the tension members through a patient'"'"'s muscle and tissue, and anchoring the first and second ends to anatomical locations.

29. The method of claim 21, further comprising adjusting the tension in at least one of the tension members.

30. The method of claim 21, wherein the first tension member includes at least one of an elastic portion, a magnetic mechanism, a pneumatic actuator, and a hydraulic actuator.

31. The method of claim 21, wherein the first tension member includes an anchor mechanism at each end of the first tension member.

32. The method of claim 31, wherein the anchor mechanism includes at least one of a screw, a loop, and an anchor having an expandable portion.

33. A method of maintaining an open airway comprising:

providing a first magnet and a second magnet, each magnet having a first end and a second end;

implanting and securing the first magnet at a location proximate a patient'"'"'s hyoid bone; and

providing the second magnet at an external location along a patient'"'"'s neck such that forces between the first and second magnets displace the hyoid bone in one or both of inferior and anterior directions, thereby increasing a luminal size of the airway.

34. The method of claim 33, wherein the second magnet is connected to an extension of a mouthpiece such that the second magnet is provided at a location spaced one or both of inferiorly and anteriorly of the first magnet, and wherein forces of attraction between the first and second magnets displace the hyoid bone in one or both of inferior and anterior directions.

35. The method of claim 33, wherein the second magnet is provided along a back portion of a patient'"'"'s neck such that the second magnet is provided at a location spaced one or both of superiorly and posteriorly of the first magnet, and wherein forces of repulsion between the first and second magnets displace the hyoid bone in one or both of inferior and anterior directions.

36. The method of claim 33, wherein the first magnet is connected to the hyoid bone by a tension member.

37. The method of claim 33, wherein providing the second magnet at an external location along a patient'"'"'s neck comprises providing a strap that houses the second magnet and is worn by the patient.

38. The method of claim 33, wherein one of the first and second magnets further comprises an additional magnet connected thereto, thereby forming a magnet pair, such that when the other of the first and second magnets moves toward the magnet pair, the forces therebetween reach zero.

39. The method of claim 38, wherein the magnet pair is arranged such that north poles of each magnet in the magnet pair face each other.

40. The method of claim 38, wherein the magnet pair is arranged such that south poles of each magnet in the magnet pair face each other.