Methods of achieving lung volume reduction with removable anchored devices

• US 7,842,061 B2
• Filed: 12/23/2003
• Issued: 11/30/2010
• Est. Priority Date: 05/17/2002
• Status: Expired due to Term

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Spiration, Inc. (Olympus Corporation)
• Inventors: Park, Mia, Yi, Seung, Rimbaugh, Jenni, DeVore, Lauri J., Corcoran, Dean T., Dillard, David H., Gonzalez, Hugo X.
• Primary Examiner(s): Milano; Michael J
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/746,981
• Publication Number:
  US 20040143282A1
• Time in Patent Office: 2,534 Days
• Field of Search: 606/95, 606/108, 606/190, 606/191, 606/192, 60416701-16704, 604/174, 604/175, 128/207.14, 128/207.15, 623/23.64, 623/23.65
• US Class Current: 606/191
• 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 2017/00809 Lung operations
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2002/043 Bronchi

Abstract

An intra-bronchial device placed and anchored in an air passageway of a patient to collapse a lung portion associated with the air passageway. The device includes a support structure, an obstructing member carried by the support structure that reduces ventilation to the lung portion by preventing air from being inhaled into the lung portion, and at least one anchor carried by the support structure that anchors the obstruction device within the air passageway. The anchor may engage the air passageway wall by piercing or friction, include a stop dimensioned for limiting the piercing of the air passageway wall, and may be releasable from the air passageway for removal of the intra-bronchial device. The anchors may be carried by a peripheral portion of the support structure, or by a central portion of the support structure. The obstructing member may be a one-way valve.

Claims

1. An intra-bronchial device for placement in an air passageway of a patient, the device comprising:

a support structure comprising a longitudinal axis extending between a distal end and a proximal end, a central member extending longitudinally from the distal end to the proximal end through an axial center of the device, the central member configured to be engaged by a removal device;

an obstructing member comprising a resilient membrane that precludes fluid flow through said resilient membrane, the obstructing member being carried by the support structure and the obstructing member preventing air from being inhaled into a lung portion to collapse the lung portion, at least a portion of the central member being surrounded by the resilient membrane; and

at least a first anchor at the distal end and a second anchor at the proximal end, the first and second anchors carried by the support structure that anchor the device within the air passageway when the anchors are deployed, the first anchor comprises a first tip and a second tip, and a distance defined between the first tip and the second tip when the anchors are deployed, and the first and the second anchors being configured to fold toward the longitudinal axis in a direction that moves the anchors away from the obstructing member without increasing the distance when the central member is engaged by the removal device.

2. The intra-bronchial device of claim 1, wherein the support structure comprises material having memory of an original shape, and resiliency to return the material to that shape.

3. The intra-bronchial device of claim 1, wherein the central member comprises an aperture configured to be engaged by the removal device.

4. The intra-bronchial device of claim 1, wherein the support structure, the central member and the membrane form a substantially umbrella-shaped device.

5. An air passageway obstructing device comprising:

flexible frame means for forming a support structure extending from a distal end to a proximal end of the air passageway obstructing device;

flexible membrane means for obstructing airflow within an air passageway, the flexible membrane means being carried by the support structure; and

anchoring means to anchor the air passageway obstructing device, the anchoring means having a first anchor at the distal end and a second anchor at the proximal end, the first anchor having a first tip and a second tip, and a distance defined between the first and second tips, the flexible frame means being expandable to an expanded state within the air passageway to support the membrane means, the anchoring means being releasable by a removal device means to remove the air passageway obstructing device from the air passageway, wherein the first and second anchors fold away from the flexible membrane means without increasing the distance when the removal device means engages the air passageway obstructing device.

6. An air passageway obstructing device comprising:

a frame that comprises a support structure and a central member extending from a distal end to a proximal end within the support structure;

a flexible membrane configured to obstruct airflow within an air passageway, the flexible membrane being carried by the support structure; and

anchoring means to anchor the air passageway obstructing device, the anchoring means having a first anchor at the distal end and a second anchor at the proximal end, the first anchor having a first tip and a second tip, and a distance defined between the first and second tips, the anchoring means being carried by the central member, the frame being expandable to an expanded state within the air passageway to support the flexible membrane, the anchoring means being releasable by a removal device means and the central member being configured to be engaged by a removal device such that retraction of the central member with the removal device following engagement of the central member by the removal device results in the first and second anchors folding away from the flexible membrane without increasing the distance.

7. The air passageway obstructing device of claim 6, wherein the flexible membrane means is supported on the support structure such that the flexible membrane forms a concave side and a convex side.

8. The air passageway obstructing device of claim 7, wherein the flexible membrane is configured to permit fluid flow from the convex side to the concave side, while precluding air from flowing from the concave side to the convex side.

9. An air passageway obstructing device for use in occluding inspiratory airflow in an airway of a lung, the air passageway obstructing device comprising an expandable frame comprising a central rod extending from a distal end to a proximal end through an axial center of the air passageway obstructing device, and the proximal end and the distal end having a plurality of metallic anchor members having tips extending radially outwards from a point of attachment of the metallic anchor members on the central rod, the tips at the distal end defining a distance between opposite tips, the distal metallic anchor members extending distally away from the proximal metallic anchor members and the proximal metallic anchor members extending proximally away from the distal metallic anchor members, the metallic anchor members being configured to engage an air passage wall, and a membrane supported on strut members that extend in a proximal direction from a distal location at which they connect to the central rod, wherein the membrane is configured to be impermeable to airflow, wherein during removal of the obstructing device from the airway the plurality of metallic anchor members at the distal end are configured to fold away from the membrane without increasing the distance.

10. The device of claim 9, wherein the device is configured to permit fluid flow in an expiratory direction along a path between the membrane and an air passageway wall.

11. The device of claim 9, wherein the metallic anchor members are configured to puncture a tissue of an airway wall to a controlled depth.

12. The device of claim 9, wherein a plane which intersects the tips of the metallic anchor members at the distal end lies distal to the distal end of the membrane.

13. The device of claim 9, wherein the central rod comprises a proximal end configured to be engaged by a retrieval device.

14. The device of claim 13, wherein the strut members are configured to return to a radially expanded position after being compressed radially to such a degree that they contact the central rod.

15. The device of claim 9, wherein proximal ends of the strut members are bent radially inwards.

16. An intra-bronchial device for placement in an air passageway of a patient, the intra-bronchial device comprising:

a support structure comprising a longitudinal axis extending between a distal end and a proximal end, a central member extending longitudinally from the distal end to the proximal end through an axial center of the intra-bronchial device, the central member configured to be engaged by a removal device;

an obstructing member comprising a resilient membrane that precludes fluid flow through said resilient membrane, the obstructing member being carried by the support structure and the obstructing member preventing air from being inhaled, at least a portion of the central member being surrounded by the resilient membrane; and

at least a first anchor carried by the support structure that anchors the intra-bronchial device within the air passageway, the first anchor forms with the longitudinal axis an acute angle when the first anchor is deployed, the first anchor positioned distal to the obstructing member, and the first anchor being configured to fold toward the longitudinal axis in a direction that moves the first anchor away from the obstructing member while decreasing the acute angle when the central member is engaged by the removal device.

17. The intra-bronchial device of claim 16, wherein the first anchor is configured to puncture a tissue of an air passageway wall to a controlled depth.

18. The intra-bronchial device of claim 16, wherein the intra-bronchial device is configured to permit fluid flow in an expiratory direction along a path between the resilient membrane and an air passageway wall.

19. The intra-bronchial device of claim 16, wherein the obstructing member and the resilient membrane form a substantially umbrella-shaped device.

20. The intra-bronchial device of claim 16, wherein the resilient membrane is supported on the support structure such that the resilient membrane forms a concave side and a convex side, and the resilient membrane is configured to permit fluid flow from the convex side to the concave side, while precluding air from flowing from the concave side to the convex side.