Methods and devices for improving breathing in patients with pulmonary disease

• US 7,992,563 B2
• Filed: 01/14/2008
• Issued: 08/09/2011
• Est. Priority Date: 06/16/2000
• Status: Expired due to Fees

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Ventus Medical, Inc.
• Inventors: Doshi, Rajiv
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US12/014,060
• Publication Number:
  US 20080173309A1
• Time in Patent Office: 1,303 Days
• Field of Search: 128/207.14, 128/207.16, 128/200.26, 128/859, 128860-862, 128/200.24, 623/9, 623/11.11, 623/14.11, 623/2.21, 623/2.2, 600/540, 600/532, 600/538, 600/539
• US Class Current: 128/207.14
• 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 sleeping patient, the device configured to be removably worn in communication with a patient'"'"'s respiratory tract, the device removable by the patient and comprising:

an opening through the device configured to provide fluid communication between an inside and an outside of the patient'"'"'s respiratory tract through the device;

a valve member configured to provide a resistance to exhalation through the device that is greater than the resistance to inhalation through the device by occluding the opening during exhalation more than during inhalation while permitting inhalation and exhalation through the device; and

an expandable anchor for removably securing the device to the patient.

2. The device of claim 1, wherein the inside of the patient'"'"'s respiratory tract includes the mouth.

3. The device of claim 1, wherein the anchor is a conformable anchor.

4. The device of claim 1, wherein the valve member is configured to occlude the opening during exhalation by a pre-determined amount.

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

6. A device for treating a sleeping patient, the device removable by the patient and comprising:

a flexible anchor configured to allow the patient to removably secure the device in communication with a patient'"'"'s respiratory tract;

an opening through the device, configured so that the patient may inhale and exhale through the opening when wearing the device; and

a valve configured to occlude the opening to limit exhalation through the opening more than inhalation through the opening.

7. The device of claim 6, wherein the anchor is configured to removably secure the device to a patient'"'"'s breathing orifice.

8. The device of claim 6, wherein the anchor is configured to removably secure the device in a patient'"'"'s mouth.

9. The device of claim 6, wherein the anchor is a conformable anchor.

10. The device of claim 9, wherein the anchor comprises a shape memory material.

11. The device of claim 6, wherein the valve comprises a flap valve.

12. The device of claim 6, wherein the valve comprises a flap valve that occludes a portion of the opening.

13. The device of claim 6, wherein the valve comprises a flap that is configured to pivot only inwards.

14. The device of claim 13, wherein the flap valve is made of a substantially flexible material.

15. A device for treating a sleeping patient, the device removable by the patient and comprising:

a housing configured to be removably secured in communication with a patient'"'"'s respiratory tract, the housing enclosing at least one valve configured to create a first flow resistance to inspiration and a second flow resistance to partially obstruct expiration, wherein the first flow resistance is less than the second flow resistance, further wherein the valve is configured to create a third flow resistance to expiration when a pressure of said expiration exceeds a threshold pressure.

16. The device of claim 15, wherein the valve is movable between first, second and third positions corresponding to the first, second and third flow resistances respectively.

17. A device for treating a sleeping patient, the device removable by the patient and comprising:

an expandable anchor configured to removably secure the device in communication with a patient'"'"'s respiratory tract;

an opening configured to provide fluid communication through the device that the patient may breathe through; and

a valve configured to obstruct at least a portion of the opening, the valve configured to limit exhalation more than inhalation through the opening, wherein the valve is configured to allow air to flow through a small area of the opening during exhalation and through a larger area of the opening during inhalation.

18. The device of claim 17, wherein the anchor is configured to removably secure the device in communication with a patient'"'"'s breathing orifice.

19. The device of claim 17, wherein the anchor is configured to removably secure the device in communication with a patient'"'"'s mouth.

20. A method of treating a sleeping patient with a device that is removable by the patient, the method comprising:

removably securing a device in communication with the patient'"'"'s respiratory tract using an expandable anchor so that the device is removable by the patient, wherein the device includes an opening through which the patient breathes and a valve configured to partially occlude the opening during exhalation and provide a resistance to exhalation that is greater than the resistance to inhalation; and

breathing through the device so that the valve partially occludes the opening during exhalation so that there is a greater a resistance to exhalation through the device than to inhalation through the device.

21. The method of claim 20, wherein the step of securing the device comprises securing the device to the patient'"'"'s breathing orifice.

22. The method of claim 20, wherein the step of securing the device comprises securing the device in the patient'"'"'s mouth.

23. A method of treating chronic obstructive pulmonary disease with a device that is removable by the patient, the method comprising:

removably and passively securing a device in communication with a patient'"'"'s respiratory tract using an expandable anchor so that the device is removable by the patient, wherein the device includes an opening through which the patient breathes and a valve configured to at least partially occlude the opening during exhalation; and

breathing through the device so that the valve at least partially closes to occlude the opening during exhalation and at least partially opens during inhalation, so that there is a greater a resistance to exhalation through the device than to inhalation through the device.

24. The method of claim 23, wherein the step of removably securing the device comprises securing the device to the patient'"'"'s breathing orifice.

25. The method of claim 23, wherein the step of removably securing the device comprises securing the device in the patient'"'"'s mouth.

26. A device for treating a sleeping patient, the device removable by the patient and comprising:

an expandable anchor having a collapsed insertion configuration and an expanded inserted configuration, wherein the anchor is configured to allow the patient to removably secure the device in communication with their respiratory tract;

an opening through the device, configured so that the patient may inhale and exhale through the opening when wearing the device; and

a valve configured to occlude the opening to limit exhalation through the opening more than inhalation through the opening.

27. The device of claim 26, wherein the inside of the patient'"'"'s respiratory tract includes the mouth.

28. The device of claim 26, wherein the anchor is conformable.

29. The device of claim 26, wherein the anchor comprises a shape memory material.

30. The device of claim 26, wherein the valve is configured to occlude the opening during exhalation by a pre-determined amount.

31. The device of claim 26, wherein the valve comprises a flap valve.