Methods and devices for improving breathing in patients with pulmonary disease

• US 20040194779A1
• Filed: 04/19/2004
• Published: 10/07/2004
• Est. Priority Date: 06/16/2000
• Status: Active Grant

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Ventus Medical, Inc.
• Inventors: Doshi, Rajiv
• Granted Patent: US 7,334,581 B2
• Time in Patent Office: Days
• US Class Current: 128/200.24
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• 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 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• 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 16/06 Respiratory or anaesthetic masks
• 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: A63B 23/18 for improving respiratory function

Abstract

Methods, apparatus, and kits for enhancing breathing in patients suffering from chronic pulmonary obstructive disease are described. The methods and apparatus rely on increasing flow resistance to expiration in a manner which mimics “pursed lip” breathing which has been found to benefit patients suffering from this disease. In a first example, a device is implanted in a trachea or bronchial passage to increase flow resistance, preferably selectively increase resistance to expiration relative to inspiration. In a second embodiment, a mouthpiece is provided, again to increase resistance to expiration, preferably with a lesser increase in flow resistance to inspiration. In a third embodiment, the patient'"'"'s trachea or bronchial passage is modified by the application of energy in order to partially close the lumen therethrough.

Claims

1. A device for treating a patient with a breathing disorder, the device configured to be held in a patient'"'"'s mouth and comprising at least one aperture providing fluid communication between an inside and an outside of the patient'"'"'s mouth through the mouthpiece, the device further comprising an obstructing member that obstructs at least a portion of the aperture, the obstructing member configured to limit exhalation air flow more than inhalation air flow through the aperture.

2. The device of claim 1, wherein the device is configured to be used by a sleeping patient.

3. The device of claim 1, wherein the device is configured to be held between a patient'"'"'s jaws.

4. The device of claim 1, wherein the obstructing member is configured to reduce an open area of the aperture by a pre-determined amount.

5. The device of claim 4, wherein the obstructing member is configured to allow air to flow through a small area of the aperture in an exhalation direction and through a larger area of the aperture in an inhalation direction.

6. The device of claim 5, wherein the larger area overlaps the small area.

7. The device of claim 6, wherein the obstructing member is further configured to allow exhalation air to flow through an area that is larger than the small area when an exhalation air pressure exceeds a predetermined value.

8. A device for use in treating a patient with a breathing disorder, the device comprising a body defining an inside surface and an outside surface and configured to be held in a patient'"'"'s mouth;

the body comprising an aperture in a front portion thereof, the aperture providing fluid communication between the inside surface and the outside surface; and

a valve device configured to limit expiratory fluid flow directed from the inside surface to the outside surface more than inspiratory fluid flow from the outside surface to the inside surface.

9. The device of claim 8, wherein the body is substantially entirely held within the patient'"'"'s mouth.

10. The device of claim 8, wherein the body is substantially U-shaped.

11. The device of claim 8, wherein the body comprises at least one concave channel configured to receive a patient'"'"'s teeth.

12. The device of claim 8, wherein the aperture has a first area and a second area that is larger than the first area, wherein the valve device is configured to permit fluid flow through only the first area in a direction from the inside surface to the outside surface, and through both the first area and the second area in a direction from the outside surface to the inside surface.

13. The device of claim 12, wherein the second area overlaps at least a portion of the first area.

14. The device of claim 12, wherein the valve device is further configured to allow fluid flow through a third area that is larger than the first area when a pressure of expiratory fluid flow exceeds a threshold value.

15. The device of claim 8, wherein the valve device comprises a movable element pivotably joined to a fixed element that is immovably attached to the body.

16. The device of claim 15, wherein the movable element is joined to the fixed element by a hinge with a pivot axis lying in a plane substantially parallel to the outside surface.

17. The device of claim 16, wherein the movable element comprises a flap that occludes at least a portion of the aperture.

18. The device of claim 17, wherein the flap is secured to the fixed element so as to allow the flap to pivot only inwards.

19. The device of claim 18, wherein the flap is made of a substantially flexible material.

20. A device for treating a patient with a breathing disorder, the device comprising:

a housing configured to be held in a patient'"'"'s mouth, the housing enclosing at least one valve configured to create a first flow resistance to inspiration and a second flow resistance to expiration, wherein the first flow resistance is less than the second flow resistance.

21. The device of claim 20, wherein the valve is further configured to create a third flow resistance to expiration when a pressure of said expiration exceeds a threshold pressure.

22. The device of claim 20, wherein the valve comprises a flap.

23. The device of claim 22, wherein the flap is movable between first, second and third positions corresponding to the first, second and third flow resistances respectively.

24. A device for enhancing breathing in a patient, the device comprising a mouth piece configured to be held substantially entirely within the patient'"'"'s mouth and means on the mouthpiece for causing an air flow resistance to expiration that is greater than an air flow resistance to inspiration.

25. The device of claim 24, wherein the means for causing an air flow resistance comprises a two-way valve.

26. A method of reducing breathing rate in a sleeping patient comprising:

placing a device in the patient'"'"'s mouth that creates a resistance to expiratory flow that exceeds a resistance to inspiratory flow.

27. The method of claim 26, and observing a reduction in breathing rate of the patient

28. The method of claim 26, further comprising allowing the patient to sleep while wearing the device.

29. The method of claim 26, wherein the device is placed in the patient'"'"'s mouth such that it does not protrude therefrom.

30. The method of claim 26, further comprising obstructing air flow through the patient'"'"'s nose.

31. A method of increasing oxygen saturation in a patient, the method comprising placing in a patient'"'"'s mouth a flow restricting device configured to resist expiration to a greater degree than inspiration.

32. The method of claim 31, further comprising measuring a change in oxygen saturation in the patient.

33. The method of claim 31, further comprising obstructing air flow through the patient'"'"'s nose.

34. The method of claim 31, further comprising allowing the patient to sleep while wearing the device.