One-way valve devices for anchored implantation in a lung

• US 7,875,048 B2
• Filed: 09/03/2004
• Issued: 01/25/2011
• Est. Priority Date: 05/17/2002
• Status: Expired due to Fees

• 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., Alferness, Clifton A., Dillard, David H., Gonzalez, Hugo X.
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/933,778
• Publication Number:
  US 20050033344A1
• Time in Patent Office: 2,335 Days
• Field of Search: 606/95, 606/108, 606/190, 606/191, 606/198, 623/23.64, 623/23.65, 128/207.15, 128/200.24
• 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 lung, the device comprising:

a generally umbrella-shaped obstructing member configured when deployed to substantially seal and preclude air from being inhaled into an air passageway while allowing fluid to flow past and around the obstructing member in an expiratory direction through the air passageway;

a first anchor positioned distally of the mid-point of the obstructing member and terminating at a plurality of first anchor tips;

a second anchor positioned proximally of the mid-point of the obstructing member and terminating at a plurality of second anchor tips; and

a support structure having a distal end and a proximal end, the support structure positioned between the first anchor and the second anchor, wherein at least one of the first anchor tips is positioned distally to the distal end of the support structure;

wherein the first and the second anchors are configured to prevent substantial migration of the device within the air passageway when the anchors are deployed, and are releasable to permit removal of the device from said passageway.

2. The intra-bronchial device of claim 1, wherein the support structure is attached to the obstructing member, the first and second anchors attached to the support structure.

3. The intra-bronchial device of claim 2, wherein at least a portion of the support structure is configured to be collapsed.

4. The intra-bronchial device of claim 1, wherein the first anchor is configured to pierce a surface of a wall of the air passageway.

5. The intra-bronchial device of claim 1, wherein the second anchor is configured to pierce a surface of a wall of the air passageway.

6. The intra-bronchial device of claim 1, wherein at least one of the first and second anchors includes a stop configured to limit the penetration of the anchor into a wall of the air passageway.

7. The intra-bronchial device of claim 1, wherein one of the first and the second anchors is configured to move from a first position to a second position to engage the air passageway.

8. The intra-bronchial device of claim 1, wherein at least one of the first and second anchors is configured to move from a first position to a second position to engage the air passageway, and to move from the second position to the first position to disengage the air passageway.

9. The intra-bronchial device of claim 1, wherein the obstructing member and at least one of the first and second anchors are configured to be deployed simultaneously.

10. The intra-bronchial device of claim 1, wherein the anchors include a resilient material for imparting a securing force to the air passageway to deform the air passageway.

11. The intra-bronchial device of claim 1, wherein the obstructing member comprises a flexible membrane.

12. The intra-bronchial device of claim 1, wherein at least one of the first and second anchors has an anchoring end configured to engage a wall of the air passageway.

13. The intra-bronchial device of claim 1, wherein the obstructing member allows air and mucus to travel past the obstructing member.

14. The intra-bronchial device of claim 1, wherein the obstructing member biases between a collapsed position and an expanded position.

15. The intra-brochial device of claim 1, wherein the obstructing member is generally parabolic.

16. The intra-bronchial device of claim 1, wherein a proximal portion of the obstructing member has a substantially cylindrical outer surface such that a substantial portion of the outer surface forms a contact zone with an interior surface of the air passageway of the lung when the device is placed in the air passageway.

17. The intra-bronchial device of claim 16, wherein the proximal portion defines an opening of the obstruction member.

18. The intra-bronchial device of claim 16, wherein a distal portion of the obstructing member tapers gradually inward.

19. The intra-bronchial device of claim 1, wherein the first anchor and second anchor each comprises at least three outwardly extending anchoring members.

20. The intra-bronchial device of claim 1, wherein the support structure comprises hypodermic needle tubing.

21. The intra-bronchial device of claim 1, wherein the support structure comprises a first peripheral portion and a second peripheral portion with at least a portion of the obstructing member positioned therebetween, the first anchor carried on the first peripheral portion and the second anchor carried on the second peripheral portion of the support structure.

22. The intra-bronchial device of claim 21, wherein the support structure comprises a plurality of elongate support members and a central support member, the plurality of elongate support members extend radially from the central support member, the central support member defines the first and second peripheral portions.

23. An intra-bronchial device comprising:

an obstructing member comprising a flexible solid membrane supported by a support frame, the flexible membrane being generally umbrella-shaped and configured to be implanted in an air passageway to substantially prevent air from flowing in a first direction past the obstructing member while substantially allowing fluid to flow around and past the obstructing member in an opposite direction;

a first anchor connected distal to one end of the obstructing member and extending in a first direction relative to the flexible membrane, the first anchor terminating at a plurality of first anchor tips;

a second anchor connected proximal to the other end of the obstructing member and extending in a second direction relative to the flexible membrane, which second direction is generally opposite to the first direction, and the second anchor terminating at a plurality of second anchor tips; and

a support structure having a distal end and a proximal end, the support structure positioned between the first anchor and the second anchor, wherein at least one of the first anchor tips is positioned distally to the distal end of the support structure;

wherein the first and second anchors are configured to substantially anchor the device within the air passageway when the anchors are deployed.

24. The intra-bronchial device of claim 23, wherein the support structure extends axially from the obstructing member, and at least one of the first anchor and the second anchor comprises a plurality of elongated members each extending radially from the support structure.

25. The intra-bronchial device of claim 23, wherein the support structure comprises an elongated body between the proximal end and the distal end of the support structure, the obstructing member carried by the elongated body, the first anchor attached to the distal end of the support structure, and the second anchor attached to the proximal end of the support structure.

26. The intra-bronchial device of claim 23, wherein the obstructing member is configured to be moved radially between an unexpanded position and an expanded position while the first and second anchors prevent substantial migration of the device in the air passageway.

27. The intra-bronchial device of claim 23, wherein the intra-bronchial device is configured for deployment through a minimally invasive access delivery device when the obstructing member and anchors are in a collapsed position.

28. The intra-bronchial device of claim 23, wherein the obstructing member is positioned between the first anchor and the second anchor.

29. The intra-bronchial device of claim 23, wherein a proximal portion of the obstructing member has a substantially cylindrical outer surface such that a substantial portion of the outer surface forms a contact zone with an interior surface of the air passageway of the lung when the device is placed in the air passageway.

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

a generally umbrella-shaped obstructing member configured to substantially seal and prevent air from being inhaled into an air passageway while allowing fluid to substantially flow around and past the obstructing member in the opposite direction through the air passageway;

a first set of anchors connected to the obstructing member and terminating at a plurality of first anchor tips;

a second set of anchors connected to the obstructing member and terminating at a plurality of second anchor tips, the first set of anchors spaced distally from the second set of anchors; and

a support structure having a distal end and a proximal end, the support structure positioned between the first set of anchors and the second set of anchors, wherein at least one of the first anchor tips is positioned distally to the distal end of the support structure.

31. The intra-bronchial device of claim 30, wherein the obstructing member is positioned in a space defined between the first set of anchors and the second set of anchors.

32. The intra-bronchial device of claim 30, wherein the support structure comprises a first portion and a second portion, at least a portion of the obstructing member being positioned between the first and the second portions of the support structure, and the first set of anchors being carried on the first portion of the support structure and the second set of anchors carried on the second portion of the support structure.

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

an obstructing member configured when deployed to substantially seal against a wall of the air passageway and preclude fluid flow in at least one direction past the obstructing member, the obstructing member being generally umbrella-shaped;

a first anchor positioned at one end of the obstructing member and terminating at a plurality of first anchor tips;

a second anchor positioned at the other end of the obstructing member and terminating at a plurality of second anchor tips; and

a support structure having a distal end and a proximal end, the support structure positioned between the first anchor and the second anchor, wherein at least one of the first anchor tips is positioned distally to the distal end of the support structure;

wherein the first and the second anchors are configured to prevent substantial migration of the device within the air passageway when the anchors are deployed and are releasable to permit removal of the device from said passageway.

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

a generally umbrella-shaped obstructing member configured when deployed to substantially seal and preclude air from being inhaled into an air passageway while allowing fluid to flow around the obstructing member in an expiratory direction through the air passageway;

at least one anchor positioned distally of the mid-point of the obstructing member, the at least one anchor adapted to extend laterally outward beyond the obstructing member and adapted to form a substantially perpendicular angle with an axial center of a central support structure in connection with the obstructing member;

the at least one anchor configured to prevent substantial migration of the device within the air passageway when the at least one anchor is deployed; and

the at least one anchor releasable to permit removal of the device from said air passageway.

35. The intra-bronchial device of claim 34, wherein the at least one anchor further comprises at least a first and a second inflection points configured to reduce strain.