Nasal respiratory devices

• US 7,735,492 B2
• Filed: 12/08/2005
• Issued: 06/15/2010
• Est. Priority Date: 12/08/2004
• Status: Expired due to Fees

• Current Assignee: Theravent, Inc
• Original Assignee: Ventus Medical, Inc.
• Inventors: Doshi, Rajiv, Howard, Robert A., Hatanaka, Motohide
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): Patel; Tarla R
• Application Number:
  US11/298,640
• Publication Number:
  US 20060150979A1
• Time in Patent Office: 1,650 Days
• Field of Search: 128/207.18, 128/206.11, 128/205.29, 128/205.27, 128/200.24, 128/206.15, 128/206.18, 128/204.11
• US Class Current: 128/207.18
• CPC Class Codes: A61M 15/002 with air flow regulating means
• 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 16/06 Respiratory or anaesthetic masks
• 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 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0688 by means of an adhesive
• CPC Class Codes: A61M 16/0694 Chin straps
• CPC Class Codes: A61M 16/106 in a path
• CPC Class Codes: A61M 16/1065 in the expiratory path
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A62B 23/06 Nose filters

Abstract

Described here are methods, devices, and kits for altering the flow of air in a respiratory cavity such as the nostrils of the nose. These methods and devices may be useful for affecting a physiologic benefit in patients suffering from a variety of medical diseases, particularly those that may benefit from “pursed-lip” breathing and non-invasive ventilation, such as COPD, heart failure, sleep apnea, and other medical disorders. The devices are typically removable devices that may be placed over or in a respiratory cavity to increase resistance to airflow within the respiratory cavity. Resistance to expiration may be selectively increased relative to inspiration. Removable nasal devices are described.

Claims

1. A nasal respiratory device for use while sleeping and adapted to be secured so that it is disposed at least partially outside of a subject'"'"'s nasal cavity, the device comprising:

an opening configured to communicate with the nasal cavity;

an airflow resistor in communication with the opening, wherein the airflow resistor is configured to increase the resistance to air exhaled through the opening to be more than the resistance to air inhaled through the opening; and

a shapeable holdfast configured to seal and to secure the nasal respiratory device so that the device is disposed at least partially outside of the subject'"'"'s nasal cavity.

2. The nasal respiratory device of claim 1, wherein the airflow resistor is configured to decrease the resistance to air exhaled through the opening when the airflow or air pressure differential across the airflow resistor exceeds a threshold level.

3. The nasal respiratory device of claim 1, wherein the airflow resistor is configured to increase the resistance to air exhaled through the opening when the airflow or the air pressure differential across the airflow resistor falls below a threshold level.

4. The nasal respiratory device of claim 1, wherein the airflow resistor comprises a flap valve.

5. The nasal respiratory device of claim 1, wherein the airflow resistor alters the inspiratory:

expiratory ratio of a user wearing the nasal respiratory device so that the inspiratory;

expiratory ratio is between about 3;

1 and about 1;

10.

6. The nasal respiratory device of claim 1 wherein the holdfast comprises a shape memory material.

7. The nasal respiratory device of claim 1 wherein the holdfast comprises a foam.

8. The nasal respiratory device of claim 1, further comprising a rim having sufficient strength to support the opening in the open state when at least part of the nasal respiratory device is inserted into the nasal cavity.

9. The nasal respiratory device of claim 1, wherein the holdfast comprises an adhesive configured to secure the nasal respiratory device to the subject.

10. The nasal respiratory device of claim 1 wherein the holdfast secures the nasal respiratory device in communication with both nasal cavities.

11. The nasal respiratory device of claim 1 further comprising an active agent selected from the group consisting of:

a drug or medicament, and an odorant.

12. The nasal respiratory device of claim 1, wherein the airflow resistor is secured within the opening.

13. The nasal respiratory device of claim 1, wherein the holdfast at least partially surrounds the opening.

14. A kit comprising:

a nasal respiratory device of claim 1; and

instructions on the use of the nasal respiratory device.

15. The nasal respiratory device of claim 1, wherein the shapeable holdfast comprises a compressible holdfast configured to secure the nasal respiratory device by expanding within the subject'"'"'s nasal cavity.

16. The nasal respiratory device of claim 1, wherein the shapeable holdfast comprises a compliant material.

17. The nasal respiratory device of claim 1, wherein the shapeable holdfast comprises a deformable material.

18. The nasal respiratory device of claim 1, wherein the shapeable material comprises silicone.

19. The nasal respiratory device of claim 1, wherein the shapeable holdfast is a distinct structure from the airflow resistor.

20. The nasal respiratory device of claim 1, wherein the airflow resistor is secured across the opening and configured to open from an attachment site that is not on the periphery of the opening.

21. The nasal respiratory device of claim 1, further comprising a tubular body surrounding the opening, wherein the wall of the passageway through the tubular body is parallel to a longitudinal axis through the passageway.

22. A nasal respiratory device for use while sleeping and adapted to be secured over a subject'"'"'s nasal cavity, the device comprising:

an opening configured to communicate with the subject'"'"'s nasal cavity;

an airflow resistor in communication with the opening, wherein the airflow resistor is configured to increase the resistance to air exhaled through the opening to be more than the resistance to air inhaled through the opening; and

an adhesive holdfast configured to attach and seal the nasal respiratory device around the opening of a single nostril.

23. The nasal respiratory device of claim 22, further comprising a rim supporting the opening.

24. The nasal respiratory device of claim 22, wherein the holdfast is configured to secure to at least a portion of the subject'"'"'s nose.

25. The nasal respiratory device of claim 22, wherein the airflow resistor comprises a flap valve.

26. The nasal respiratory device of claim 22, wherein the adhesive holdfast is configured to secure the nasal respiratory device at least partially over the subject'"'"'s nasal cavity so that the nasal respiratory device does not substantially contact the inside of the nasal cavity.

27. A nasal respiratory device for use while sleeping and adapted to be secured so that it is disposed at least partly outside a subject'"'"'s nasal cavity, the device comprising:

a passageway configured to communicate with a subject'"'"'s nasal cavity;

a rim having sufficient strength to support the passageway in the open state when the nasal respiratory device is inserted into the nasal cavity;

an airflow resistor in communication with the passageway, wherein the airflow resistor inhibits exhalation more than inhalation; and

a compressible holdfast to seal and secure the nasal respiratory device so that the device is disposed at least partly outside a subject'"'"'s nasal cavity, wherein the holdfast comprises a compressible material.

28. The nasal respiratory device of claim 27, wherein the holdfast comprises a shape memory material foam.

29. The nasal respiratory device of claim 27, wherein the airflow resistor comprises a flap valve.

30. The nasal respiratory device of claim 27, wherein the rim is configured so that the rim does not form a complete seal within a subject'"'"'s nasal cavity.

31. A nasal respiratory device for use while sleeping and adapted to be secured at least partially outside a subject'"'"'s nasal cavity comprising:

an opening configured to communicate with the nasal cavity;

an airflow resistor in communication with the opening configured to increase the resistance to air exhaled through the opening to be more than the resistance to air inhaled through the opening; and

an adhesive holdfast configured to attach and seal the nasal respiratory device around the opening of a single nostril without covering the subject'"'"'s mouth.