Bronchoscopic repair of air leaks in a lung

• US 8,974,527 B2
• Filed: 03/29/2013
• Issued: 03/10/2015
• Est. Priority Date: 08/08/2003
• Status: Active Grant

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Spiration, Inc. (Olympus Corporation)
• Inventors: Gonzalez, Hugo Xavier, Springmeyer, Steven C., Sirokman, William A.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US13/853,433
• Publication Number:
  US 20140031849A1
• Time in Patent Office: 711 Days
• Field of Search: 623/9
• US Class Current: 623/9
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61F 2002/043 Bronchi

Abstract

Systems and devices for minimally invasively treating an air leak in a lung comprise the steps of detecting an air leak in a lung; locating an airway in fluid communication with the air leak, introducing a bronchoscope into a patient'"'"'s airway to a position adjacent the target section and occluding an airway upstream of the air leak for a period of time. The airway occlusion device is preferably removed after the air leak has substantially permanently healed. The occluding device may be a one-way valve. The occluding device may also comprise strut members and anchors that penetrate an airway wall.

Claims

1. A system for treating the lung, the system comprising:

a balloon catheter;

a delivery catheter having a distal end and a proximal end; and

a bronchial device configured to transition between a stored configuration and a deployed configuration, the bronchial device configured to fit within a distal portion of the delivery catheter when in the stored configuration, the bronchial device comprising;

an occlusion portion, the occlusion portion obstructing airflow in an airway in an inhalation direction when the bronchial device is deployed in the airway, the occlusion portion having an open proximal end and a closed distal end; and

an anchor portion connected to the distal end of the occlusion portion, the anchor portion including a plurality of anchors extending in a distal direction from an anchor hub, each of the plurality of anchors having a flattened shape and bifurcated into a piercing tip and an anchor stop, the anchor stop configured to limit a depth to which the piercing tip pierces a wall of the airway in which the bronchial device is deployed.

2. The system of claim 1, wherein the balloon catheter fits within a working channel of a bronchoscope when in a deflated configuration.

3. The system of claim 1, wherein the occlusion portion includes a plurality of struts.

4. The system of claim 3, wherein the struts and the anchors are formed via cutting and shaping a single tubular piece of material.

5. The system of claim 3, wherein the occlusion portion includes a flexible membrane covering and contacting at least a portion of one or more of the plurality of struts.

6. The system of claim 1, wherein airflow is permitted to bypass the bronchial device in an expiratory direction between an outer periphery of the open end of the occlusion portion and the wall of the airway.

7. The system of claim 1, wherein the occlusion portion inhibits passage of air through the bronchial device inside an outer periphery of the occlusion portion.

8. The system of claim 1, wherein the bronchial device is biased to transition to the deployed configuration upon removal of the bronchial device from the delivery catheter.

9. The system of claim 1, wherein the occlusion portion is formed from placing a mandrel inside a concave space of a frame and dipping the frame into a molten solution of a desired polymer.

10. A method of treating an air leak within a lung, the method comprising:

guiding a balloon catheter to a first airway within the lung, the balloon catheter configured to occlude an airway in the lung when in an inflated configuration;

occluding the first airway while measuring the diameter of the first airway;

recording a change in air leak rate correlating to the occluding of the first airway;

repeating the guiding, occluding, measuring, and recording steps in other airways until a target airway is identified; and

deploying a one-way valve in the target airway to occlude inspiratory airflow in the target airway.

11. The method of claim 10 further comprising detecting an air leak in a lung.

12. The method of claim 10 further comprising deploying a second one-way valve in a second target airway to occlude inspiratory airflow in the target airway.

13. The method of claim 10 further comprising removing the one-way valve from the target airway.

14. The method of claim 13, wherein removing the one-way valve comprises pulling the one-way valve in a proximal direction and collapsing an anchor portion of the one-way valve in a distal direction with respect to an occlusion portion of the one-way valve.

15. The method of claim 10 further comprising guiding a delivery catheter to the target airway.

16. The method of claim 10 further comprising guiding a bronchoscope to the target airway.

17. The method of claim 15, wherein the balloon catheter comprises one or more markings on a proximal end of the balloon catheter and the method further comprises marking the first target location.

18. The method of claim 10 further comprising deploying a second one-way valve having a different size than the one-way valve deployed in the target airway.

19. The method of claim 10, wherein the one-way valve is deployed in a third generation airway.