Intraoral apparatus for enhancing airway patency

• US 20010047805A1
• Filed: 01/17/2001
• Published: 12/06/2001
• Est. Priority Date: 01/21/2000
• Status: Active Grant

• Current Assignee: RIC INVESTMENTS LLC (Koninklijke Philips N.V.)
• Original Assignee: Respironics Incorporated (Koninklijke Philips N.V.)
• Inventors: Rogers, Robert R., Scarberry, Eugene N., Starr, Eric W., Busch, Lance, Sanders, Mark H., Barnett, Shari
• Granted Patent: US 6,877,513 B2
• Time in Patent Office: Days
• US Class Current: 128/206.29
• 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: A61M 16/0493 with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
• CPC Class Codes: A61M 16/0495 with tongue depressors
• CPC Class Codes: A61M 16/101 using an oxygen concentrator
• CPC Class Codes: Y10S 602/902 Antisnoring or mouth closing devices

Abstract

An apparatus for selectively positioning intraoral anatomic features of a human patient to enhance upper airway stability for use alone or in combination with positive airway pressure as therapeutic treatment for obstructive sleep apnea and other conditions, such as snoring, which are symptomatic of upper airway instability.

Claims

1. An apparatus for enhancing patency of a user'"'"'s airway comprising:

a first member adapted to contact a portion of a user;

a flexible sleeve adapted to be received at least partially within such a user'"'"'s oral cavity and adapted to receive a portion of such a user'"'"'s tongue therein, wherein the flexible sleeve is of sufficient flexibility that, during use, the flexible sleeve readily collapses about the portion of such a user'"'"'s tongue received therein upon application of a vacuum within the sleeve to retain the portion of such a user'"'"'s tongue in a fixed position relative to such a user'"'"'s upper or lower dentition; and

a first connecting assembly cooperable with the first member and the flexible sleeve to maintain the fixed position of the first member relative to the flexible sleeve during use of the apparatus.

2. The apparatus as set forth in

claim 1

, wherein the first member engages at least one of a user'"'"'s upper dentition, lower dentition, and a facial region proximate to such a user'"'"'s mouth.

3. The apparatus as set forth in

claim 1

, wherein the first member, the flexible sleeve, and the first connecting assembly are configured and arranged such that the fixed position is a position advanced forwardly from a normal position of a user'"'"'s tongue relative to such a user'"'"'s upper dentition.

4. The apparatus as set forth in

claim 1

, wherein the first connecting assembly is configured and arranged to provide selective adjustment of a relative positional relationship between the first member and the flexible sleeve with respect to each other to control a position of a user'"'"'s tongue relative to an upper dentition.

5. The apparatus as set forth in

claim 4

, wherein the first connecting assembly includes a rotary screw actuated by rotation thereof for adjustment of the relative positional relationship between the first member and the flexible sleeve with respect to each other.

6. The apparatus as set forth in

claim 4

, wherein the first connecting assembly includes a protruding element operatively coupled to the first member and the flexible sleeve such that the flexible sleeve is selectively adjustable over a plurality of discrete positions relative to the first member by adjusting a position of the protruding relative to the first member.

7. The apparatus as set forth in

claim 6

, wherein:

(a) the protruding element is a flexible conduit used to communicate a vacuum with an interior of the sleeve and includes a plurality of spaced apart locking elements disposed thereon;

(b) the first member includes a locking aperture; and

(c) each locking element is independently cooperable with the locking aperture for locking the protruding element in one of the plurality of discrete relative positions.

8. The apparatus as set forth in

claim 4

, further comprising:

a motor connected to the first connecting assembly for moving the flexible sleeve relative to the first member responsive to actuation of the motor; and

a controller coupled to the motor, wherein the controller controls the actuation of the motor.

9. The apparatus as set forth in

claim 8

, further comprising a sensor for monitoring a parameter associated with such a user, and wherein the controller controls the actuation of the motor based on the monitored parameter.

10. The apparatus as set forth in

claim 1

, wherein the first member is adapted to engage a user'"'"'s upper dentition, the apparatus further comprising:

a second member adapted to engage a user'"'"'s lower dentition; and

a second connecting assembly cooperable with the second member and at least one of the first member and the flexible sleeve to maintain a predetermined relative positional relationship therebetween.

11. The apparatus as set forth in

claim 10

, wherein the second connecting assembly and second member are configured and arranged such that, in use, the second member retains a user'"'"'s lower dentition in a position advanced forwardly from a normal position thereof with respect to such a user'"'"'s upper dentition.

12. The apparatus as set forth in

claim 10

, wherein the second connecting assembly is configured and arranged to provide selective adjustment of a position of a user'"'"'s lower dentition relative to such a user'"'"'s upper dentition.

13. The apparatus as set forth in

claim 12

, further comprising:

a motor connected to the second connecting assembly for moving the second member relative to the first member responsive to actuation of the motor; and

a controller coupled to the motor, wherein the controller controls the actuation of the motor.

14. The apparatus as set forth in

claim 13

, further comprising a sensor for monitoring a parameter associated with such a user, and wherein the controller controls the actuation of the motor based on the monitored parameter.

15. The apparatus as set forth in

claim 1

, further comprising:

a vacuum source; and

a delivery system that communicates the vacuum source with an interior of the flexible sleeve.

16. The apparatus as set forth in

claim 1

, further comprising

a passage defined through at least one of the first member and the connecting assembly, and

a positive airway pressure source for providing positive pressure breathing gas in an upper airway of a user via the passage.

17. The apparatus as set forth in

claim 1

, wherein the first member includes a tongue receiving cavity adapted to receive at least a portion of the flexible sleeve, wherein a first opening is provided in the first member for communicating a vacuum source with the tongue receiving cavity, wherein a second opening is provided in the first member for disposing the flexible sleeve in the tongue receiving cavity, wherein the second opening is sealed responsive to the flexible sleeve being positioned in the tongue receiving cavity so that the vacuum can be maintained in the tongue receiving cavity, and wherein the flexible sleeve includes an opening defined therein for communicating an interior of the flexible sleeve with the tongue receiving cavity.

18. The apparatus as set forth in

claim 17

, wherein an end portion of the flexible sleeve engages a portion of the first member proximate to the second opening to form the seal.

19. An apparatus for enhancing patency of a user'"'"'s airway comprising:

a first member adapted tocontact a portion of a user;

a second member adapted to be received at least partially within such a user'"'"'s oral cavity in engagement with such a user'"'"'s soft palate for retaining a portion thereof in a fixed relative to such a user'"'"'s upper or lower dentition; and

a first connecting assembly cooperable with the first member and the second member to maintain the fixed position of the first member relative to the second member during use of the apparatus.

20. The apparatus as set forth in

claim 19

, wherein the first member engages at least one of a user'"'"'s upper dentition, lower dentition, and a facial region proximate to such a user'"'"'s mouth.

21. The apparatus as set forth in

claim 19

, wherein the fixed position is a position advanced upwardly and forwardly from the normal position thereof with respect to a user'"'"'s upper dentition.

22. The apparatus as set forth in

claim 19

, wherein the first connecting assembly is configured and arranged to provide selective adjustment of a relative positional relationship between the first member and the second member with respect to each other to control a position of a user'"'"'s soft palate relative to an upper dentition.

23. The apparatus as set forth in

claim 22

, further comprising:

a motor connected to the first connecting assembly for moving the second member relative to the first member responsive to actuation of the motor; and

a controller coupled to the motor, wherein the controller controls the actuation of the motor.

24. The apparatus as set forth in

claim 23

, further comprising a sensor for monitoring a parameter associated with such a user, and wherein the controller controls the actuation of the motor based on the monitored parameter.

25. The apparatus as set forth in

claim 19

, wherein said second member includes a vacuum cup engageable with a user'"'"'s soft palate to form a cavity therebetween, and wherein the apparatus further comprises:

a vacuum source; and

a delivery system that communicates the vacuum source the cavity.

26. The apparatus as set forth in

claim 19

, further comprising means for providing positive airway pressure in an upper airway of a user.

27. The apparatus as set forth in

claim 19

, wherein the first member is adapted to engage a user'"'"'s upper dentition, the apparatus further comprising:

a third member adapted to engage a user'"'"'s lower dentition; and

a second connecting assembly cooperable with the third member and at least one of the first member and the second member to maintain a predetermined relative positional relationship therebetween.

28. The apparatus as set forth in

claim 27

, wherein the second connecting assembly and third member are configured and arranged such that, in use, the third member retains a user'"'"'s lower dentition in a position advanced forwardly from a normal position thereof with respect to such a user'"'"'s upper dentition.

29. The apparatus as set forth in

claim 27

, wherein the second connecting assembly is configured and arranged to provide selective adjustment of a position of a user'"'"'s lower dentition relative to such a user'"'"'s upper dentition.

30. The apparatus as set forth in

claim 29

, further comprising:

a motor connected to the second connecting assembly for moving the third member relative to the first member responsive to actuation of the motor; and

a controller coupled to the motor, wherein the controller controls the actuation of the motor.

31. The apparatus as set forth in

claim 30

, further comprising a sensor for monitoring a parameter associated with such a user, and wherein the controller controls the actuation of the motor based on the monitored parameter.

32. A system for enhancing patency of a user'"'"'s airway comprising:

an oral appliance adapted to retain a user'"'"'s lower jaw in a selected position displaced generally in the forward direction from the normal position thereof;

a passageway defined in the oral appliance to communicate an interior of the oral appliance with an exterior thereof;

a pressure generating device adapted to provide a flow of breathing gas at a positive pressure; and

a patient circuit coupled to the pressure generating device and the oral appliance to communicate the flow of breathing gas with the an airway of a user via the passageway in the oral appliance.

33. The system as set forth in

claim 32

, wherein the oral appliance includes:

a first tray defined in a first surface of the oral appliance and configured and arranged correspond generally to a user'"'"'s upper dentition;

a second tray defined in a second surface of the oral appliance and configured and arranged correspond generally to a user'"'"'s lower dentition; and

a formable substance disposed in the first tray and the second tray and conformable to a user'"'"'s upper dentition and lower dentition, respectively.

34. The system as set forth in

claim 33

, wherein the formable substance is a thermosetting plastic that is formable for conforming engagement with a user'"'"'s upper dentition and lower dentition.

35. The system as set forth in

claim 32

, wherein the oral appliance includes:

a first member adapted to engage a user'"'"'s upper dentition;

a second member adapted to engage a user'"'"'s lower dentition; and

a connecting assembly cooperable with the first member and the second member to provide selective adjustment of a position of a user'"'"'s lower dentition relative to such a user'"'"'s upper dentition.

36. The system as set forth in

claim 35

, further comprising:

a motor connected to the second connecting assembly for moving the first member relative to the second member responsive to actuation of the motor; and

a controller coupled to the motor, wherein the controller controls the actuation of the motor.

37. The system as set forth in

claim 36

, further comprising a sensor for monitoring a parameter associated with such a user, and wherein the controller controls the actuation of the motor based on the monitored parameter.

38. An apparatus for enhancing patency of a user'"'"'s airway comprising:

a first member adapted to engage a user'"'"'s upper dentition;

a second member adapted to engage a user'"'"'s lower dentition; and

a connecting assembly cooperable with the first member and the second member to provide both (1) selective adjustment of a position of a user'"'"'s lower dentition relative to such a user'"'"'s upper dentition and (2) a continuous bias force urging the second member in an anterior direction relative to the first member.

39. The apparatus as set forth in

claim 38

, wherein the first member includes a first tray configured and arranged correspond generally to a user'"'"'s upper dentition, the second member includes a second tray configured and arranged correspond generally to a user'"'"'s lower dentition, and further comprising a formable substance disposed in the first tray and the second tray and conformable to a user'"'"'s upper dentition and lower dentition, respectively.

40. The apparatus as set forth in

claim 38

, wherein the connecting assembly includes:

a ratcheting adjustment assembly that provides the selective discrete adjustment of the position of a user'"'"'s lower dentition relative to such a user'"'"'s upper dentition; and

a spring bias assembly that provides the continuous bias force urging the second member in an anterior direction relative to the first member.

41. The apparatus as set forth in

claim 40

, wherein the spring bias assembly includes a biasing spring having a first end operatively coupled to one of the first member and the second member, and wherein the ratcheting adjustment assembly includes (1) a ratchet engaging cog assembly disposed on a second end of the biasing spring and (2) a ratchet rack disposed on a remaining other one of the first member and the second member, wherein the ratchet engaging cog assembly cooperates with the ratchet rack to provide discrete adjustment of a position of the first member relative to the second member.