Layered nasal devices

• US 8,985,116 B2
• Filed: 06/07/2007
• Issued: 03/24/2015
• Est. Priority Date: 06/07/2006
• Status: Expired due to Fees

• Current Assignee: Theravent, Inc
• Original Assignee: Theravent, Inc
• Inventors: Doshi, Rajiv, Loomas, Bryan, Pierce, Ryan Kendall, Ferdinand, Arthur, Sandoval, Arthur G., Servaites, Jeffrey W., Durack, Matthew, Kennedy, Daniel Francis
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US11/759,916
• Publication Number:
  US 20070283962A1
• Time in Patent Office: 2,847 Days
• Field of Search: 128/207.12, 128/206.27, 128/206.25, 128/206.21, 128/206.23, 128/200.24, 128/201.18, 128/205.27, 128/205.29, 128/206.11, 128/206.12, 128/206.14, 128/206.15, 128/206.18, 128/207.18
• US Class Current: 128/207.18
• CPC Class Codes: A61F 5/08 Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 15/085 Fixing means therefor
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0688 by means of an adhesive
• CPC Class Codes: A61M 16/0866 Passive resistors therefor
• CPC Class Codes: A61M 16/106 in a path
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A62B 23/06 Nose filters

Abstract

Described herein are nasal devices. In particular, layered nasal respiratory devices are described. Layered nasal device may include a layered airflow resistor that is configured to resist airflow in a first direction more than airflow in a second direction and that includes a flap valve adjacent to a flap valve limiting layer and an adhesive holdfast layer that is configured to secure the layered airflow resistor in communication with the subject'"'"'s nasal cavity. Methods of using and methods of assembling layered nasal device are also described.

Claims

1. A layered nasal device adapted to be adhesively secured in communication with a subject'"'"'s nasal cavity, the device comprising:

a layered airflow resistor configured to inhibit exhalation more than inhalation, wherein the layered airflow resistor comprises a flap valve adjacent to a flap valve limiting layer

at least one leak pathway through the device through which air may pass even when the airflow resistor is closed; and

an adhesive holdfast layer configured to secure the layered airflow resistor in communication with the subject'"'"'s nasal cavity.

2. The device of claim 1, wherein the airflow resistor layer is disposed substantially in the plane of the adhesive holdfast layer.

3. The device of claim 1, wherein the adhesive holdfast layer comprises a flexible substrate and a biocompatible adhesive.

4. The device of claim 1, wherein the layered airflow resistor comprises the at least one leak pathway.

5. The device of claim 1, wherein the flap valve comprises a plurality of valve leaflets.

6. The device of claim 1, wherein the flap valve is part of a flap valve layer.

7. The device of claim 1, wherein the flap valve comprises a plurality of valve leaflets formed in a flap valve layer.

8. The device of claim 1, wherein the flap valve comprises a plurality of valve leaflets configured to open from a central point.

9. The device of claim 1, wherein the flap valve is formed from the adhesive holdfast layer.

10. The device of claim 1, wherein the flap valve comprises silicone or polyurethane.

11. The device of claim 1, wherein the flap valve limiting layer comprises a mesh.

12. The device of claim 1, further comprising an alignment guide.

13. The device of claim 12, wherein the alignment guide comprises a ring.

14. The device of claim 12, wherein the alignment guide comprises a conical alignment guide.

15. The device of claim 1, further comprising a tactile alignment guide.

16. The device of claim 1, further comprising a visual alignment guide.

17. The device of claim 1, further comprising a support frame.

26. The device of claim 1, wherein the layered nasal device is generally planar.

27. The device of claim 1, wherein the layered nasal device is flexible.

38. The device of claim 1, wherein the device has a resistance exhalation of between 0.01 and 100 cm of H₂O measured at a flow rate of 100 ml/sec.

18. A layered nasal device adapted to be adhesively secured in communication with a subject'"'"'s nasal cavity, the device comprising:

a layered airflow resistor configured to inhibit exhalation more than inhalation, wherein the layered airflow resistor comprises a flap valve adjacent to a flap valve limiter and a leak pathway through the flap valve through which air may pass even when the airflow resistor is closed;

a layered adhesive holdfast comprising

a substrate layer, and

a layer of biocompatible adhesive.

19. The device of claim 18, wherein the layered adhesive holdfast at least partially surrounds the layered airflow resistor.

20. The device of claim 18, further comprising an alignment guide selected from the group consisting of:

a ring, a conical alignment guide, a tactile alignment guide, and a visual alignment guide.

21. The device of claim 18, further comprising a support frame.

22. The device of claim 18, further comprising a support frame layer.

23. The device of claim 18, wherein the flap valve is formed from the substrate layer of the layered adhesive holdfast.

24. The device of claim 18, wherein the flap valve comprises a plurality of valve leaflets configured to open from a central point.

25. The device of claim 18, wherein the flap valve limiter is selected from the group consisting of:

a mesh, a strut, a plurality of struts, and a plurality of partial struts.

39. The device of claim 18, wherein the device has a resistance exhalation of between 0.01 and 100 cm of H₂O measured at a flow rate of 100 ml/sec.

28. An adhesive nasal device that is adapted to be secured in communication with a subject'"'"'s nasal cavity, the device comprising:

an airflow resistor configured to inhibit exhalation more than inhalation

a leak pathway through the flap valve through which air may pass even when the airflow resistor is closed; and

a flexible adhesive holdfast layer configured to secure the airflow resistor in communication with the subject'"'"'s nasal cavity, wherein the adhesive holdfast layer extends at least partially around the airflow resistor.

29. The device of claim 28, further comprising an alignment guide.

30. The device of claim 28, wherein the airflow resistor comprises a layered airflow resistor that is substantially planar.

31. The device of claim 28, wherein the airflow resistor includes a layered airflow resistor comprising a flap valve layer and a valve limiter.

32. The device of claim 28, wherein the adhesive nasal device is configured to be secured over both of a subject'"'"'s nostrils.

33. The device of claim 28, wherein the flexible adhesive holdfast layer extends away from the airflow resistor and is configured to form a seal around one or both of the subject'"'"'s nostrils.

34. The device of claim 28, wherein the flexible adhesive holdfast layer comprises a substrate layer and a biocompatible adhesive.

35. The device of claim 28, wherein the adhesive nasal device is generally flat and configured to be secured over at least one of a subject'"'"'s nostrils.

36. The device of claim 28, wherein the layered nasal device is generally planar.

37. A layered nasal device that is generally planar and is adapted to be adhesively secured in communication with a subject'"'"'s nasal cavity, the device comprising:

a layered airflow resistor configured to inhibit exhalation wore than inhalation, wherein the layered airflow resistor comprises a flap valve adjacent to a flap valve limiting layer and a leak pathway through which air may pass even when the airflow resistor is closed; and

an adhesive holdfast layer extending at least partially around the layered airflow resistor and configured to secure the layered airflow resistor in communication with the subject'"'"'s nasal cavity.

40. A layered nasal device adapted to be adhesively secured in communication with a subject'"'"'s nasal cavity, the device comprising:

a layered airflow resistor configured to inhibit exhalation more than inhalation, wherein the layered airflow resistor comprises a flap valve adjacent to a flap valve limiting layer;

at least one leak pathway through the device through which air may pass during exhalation; and

an adhesive holdfast layer configured to secure the layered airflow resistor in communication with the subject'"'"'s nasal cavity.