Methods and devices for improving breathing in patients with pulmonary disease

• US 6,722,360 B2
• Filed: 06/14/2001
• Issued: 04/20/2004
• Est. Priority Date: 06/16/2000
• Status: Expired due to Term

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Spiration, Inc. (Olympus Corporation)
• Inventors: Doshi, Rajiv
• Primary Examiner(s): Lewis, Aaron J.
• Assistant Examiner(s): PATEL, MITAL B
• Application Number:
  US09/881,862
• Publication Number:
  US 20010052344A1
• Time in Patent Office: 1,041 Days
• Field of Search: 128/207.14, 128/207.16, 128/200.26, 128/859, 128/860, 128/861, 128/862, 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: 128/200.24
• 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 partially occluding an airway in a patient, the device comprising:

a frame having at least one anchoring member and configured to be implanted within a trachea or bronchial passage thereby dividing a lumen of the trachea or bronchial passage into a first portion and a second portion, the frame being further arranged to allow inspiration and expiration air flow through the first portion; and

means on the frame for increasing resistance to expiration air flow through the second portion.

2. The device of claim 1 wherein the means selectively increases air flow resistance to expiration while increasing resistance to inspiration to a lesser extent.

3. The device of claim 2 wherein the means comprises a flow responsive element which opens to inspiration and closes to expiration.

4. The device of claim 1 wherein the means comprises a fixed element.

5. A device for enhancing breathing in a patient suffering from chronic obstructive pulmonary disease, the device comprising:

a mouth piece for holding in 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 inspiraton, the inspiration and expiration being along the same air flow pathway.

6. A method for treating patients suffering from chronic obstructive pulmonary disease, the method comprising:

providing flow resistor configured to substantially resist airflow in a first direction past the resistor without entirely occluding airflow in the first direction, the resistor being further configured to substantially allow airflow in a second direction past the resistor;

implanting the flow resistor in a bi-directional airway of a patient in such an orientation that the resistor resists expiratory air flow more than inspiratory air flow.

7. The method of claim 6 wherein providing a flow resistor comprises providing a valve with a movable occluding member.

8. A method for treating patients suffering from chronic obstructive pulmonary disease, the method comprising:

implantably creating a resistance in a tracheal or bronchial passage to a portion of expiratory air flow by implanting a flow resistor in the trachea or bronchial passage;

wherein the flow resistor comprises an implantable frame and means on the frame for selectively increasing flow resistance to expiration.

9. A method for treating patients suffering from chronic obstructive pulmonary disease, the method comprising:

creating a resistance in a tracheal or bronchial passage to a portion of expiratory air flow by applying energy to a portion of the tracheal or bronchial passage to alter a section of tissue in the passage to partially occlude the lumen of the passage.

10. A device that partially occludes an airway in a patient, the device including:

an air flow element having at least one anchoring member and configured for implantation within an airway including at least one of a trachea and a bronchus, wherein the airway is divided into a first portion and a second portion by the device;

the air flow element further having an air flow pathway that allows inspiration and expiration air flow through the first portion and an air flow resistance element that resists expiration air flow through the second portion.

11. The device of claim 10 wherein the air flow resistance element provides a first flow resistance to inspiration and a second flow resistance to expiration, the second flow resistance being greater than the first flow resistance.

12. The device of claim 10 wherein the air flow resistance element comprises a valve.

13. The device of claim 12 further including a frame that supports the valve.

14. The device of claim 10 wherein the air flow resistance element provides a first flow resistance to air flow from proximal airways to distal airways, a second flow resistance to first air flow from distal airways to proximal airways, and a third flow resistance to second air flow from distal airways to proximal airways, wherein the second flow resistance is greater than the third flow resistance and the second airflow from distal airways to proximal airways is greater than the first airflow from distal airways to proximal airways.

15. The device of claim 14 wherein the third air flow resistance is greater than the first air flow resistance.

16. A device for partially occluding an airway in a patient, the device comprising:

a frame configured to be implanted within an airway of a patient, said frame dividing said airway into a first portion and a second portion, wherein the frame is configured to allow both inspiratory and expiratory air to flow past the frame in the first portion, and wherein the frame comprises an airflow-impeding member configured to increase resistance to expiratory airflow through the second portion.

17. The device of claim 16, wherein the frame comprises an anchor member configured to engage an airway wall to retain the device against movement within the airway.

18. The device of claim 17, wherein the first portion comprises an area between the airflow-impeding member and the airway wall.

19. The device of claim 16, wherein the airflow-impeding member is configured to allow inspiratory airflow to flow through the second portion substantially unimpeded.

20. The device of claim 19, wherein the airflow-impeding member comprises a hinged flap.

21. A device for increasing resistance to expiratory airflow in a patient, the device comprising:

a frame configured to be implanted within a trachea or a bronchial passageway of a patient, the frame comprising an airflow-restricting member, wherein the airflow restricting member is configured to create a first resistance to expiratory airflow that is substantially greater than a resistance to inspiratory airflow.

22. The device of claim 21, wherein the resistance to inspiratory airflow is substantially negligible in relation to the resistance to expiratory airflow.

23. The device of claim 21, wherein the airflow-restricting member is further configured to create a second resistance to expiratory airflow when an expiratory air pressure exceeds a threshold value, the second resistance to expiratory airflow being less than said first resistance to expiratory airflow.