Bronchial flow control devices and methods of use

• US 6,941,950 B2
• Filed: 10/10/2002
• Issued: 09/13/2005
• Est. Priority Date: 10/11/2001
• Status: Expired due to Term

• Current Assignee: Pulmonx Corp.
• Original Assignee: Emphasys Medical, Inc. (Pulmonx Corp.)
• Inventors: Hendrickson, Michael J., Sutton, Donald, Gifford, Hanson S. III, Fields, Antony J., Hundertmark, Ronald, Barrett, Michael S., Tholfsen, David R., Rapacki, Alan R., McCutcheon, John G., Wilson, Peter M.
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): PATEL, NIHIR B
• Application Number:
  US10/270,792
• Publication Number:
  US 20030070682A1
• Time in Patent Office: 1,069 Days
• Field of Search: 128/200.26, 128/207.14, 128/207.15, 128/207.16, 128/912, 128/200.24, 623/1.11, 623/1.12, 623/1.24, 623/9, 600/104, 606/108
• US Class Current: 128/207.14
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: Y10S 128/912 Connections and closures for tubes delivering fluids to or from the body

Abstract

Disclosed are methods and devices for regulating fluid flow to and from a region of a patient'"'"'s lung, such as to achieve a desired fluid flow dynamic to a lung region during respiration and/or to induce collapse in one or more lung regions. An identified region of the lung is targeted for treatment, such as to modify the flow to the targeted lung region or to achieve volume reduction or collapse of the targeted lung region. The targeted lung region is then bronchially isolated to regulate airflow into and/or out of the targeted lung region through one or more bronchial passageways that feed air to the targeted lung region. The bronchial isolation of the targeted lung region is accomplished by implanting a flow control device into a bronchial passageway that feeds air to a targeted lung region.

Claims

1. A flow control device for a bronchial passageway, comprising:

a valve member that regulates fluid flow through the flow control device;

a seal member that at least partially surrounds the valve member, wherein the seal member extends radially outward and forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway;

an anchor member secured to the seal member, wherein the anchor member exerts a radial force against the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway and retains the flow control device in a fixed location in the bronchial passageway; and

a valve protector that at least partially surrounds the valve member, the valve protector having sufficient rigidity to maintain the shape of the valve member against compression;

wherein the seal member includes a first flange that at least partially surrounds an outer perimeter of the flow control device and that extends radially outward a first distance with respect to a longitudinal axis of the flow control device.

2. A flow control device as defined in claim 1, wherein the seal member includes a second flange that at least partially surrounds an outer perimeter of the flow control device and that extends radially outward a second distance with respect to a longitudinal axis of the flow control device.

3. A flow control device as defined in claim 2, wherein the first radial distance is different from the second radial distance.

4. A flow control device as defined in claim 1, wherein the flange is oriented at an angle with respect to the longitudinal axis.

10. A flow control device as defined in claim 1, wherein the valve member regulates fluid flow through the flow control device by permitting fluid at a cracking pressure to flow through the flow control device in a first direction and preventing fluid from flowing through the flow control device in a second direction opposed to the first direction.

11. A flow control device as defined in claim 10, wherein the valve member comprises a duckbill valve.

12. A flow control device as defined in claim 1, wherein the valve protector includes at least one hole that extends through the valve protector member, and wherein the hole provides a location where a removal device can grasp the flow control device.

13. A flow control device as defined in claim 1, wherein the valve protector member is manufactured of a super-elastic material.

14. A flow control device as defined in claim 1, wherein the valve protector member is rigid.

15. A flow control device as defined in claim 1, wherein the anchor member comprises a frame formed by a plurality of struts including curved struts that flare outward with respect to a longitudinal axis of the flow control device, such that when the flow control device is placed in a bronchial passageway, the curved struts can anchor into bronchial walls of the bronchial passageway and prevent migration of the flow control device in a first direction.

16. A flow control device as defined in claim 15, wherein the frame is formed by a plurality of struts that form one or more prongs that can anchor into bronchial walls of the bronchial passageway and prevent the flow control device from migrating in a second direction when the flow control device is placed in the bronchial passageway.

17. A flow control device as defined in claim 1, wherein the anchor member is expandable and contractible in a radial direction with respect to a longitudinal axis of the flow control device between a relaxed state and a compressed state, such that when the flow control device is in the relaxed state, the flow control device has a diameter that is larger than the diameter of the flow control device when in the compressed state.

18. A flow control device as defined in claim 17, wherein the anchor member can expand and contract independently of the valve member, and seal member.

19. A flow control device as defined in claim 1, wherein the anchor member at least partially surrounds the seal member.

20. A flow control device as defined in claim 1, wherein the valve protector entirely surrounds the valve member.

21. A flow control device as defined in claim 1, wherein the valve protector is at least partially surrounded by the seal member.

22. A flow control device as defined in claim 1, additionally comprising a drug that coats at least a portion of the flow control device.

5. A flow control device for a bronchial passageway, comprising:

a valve member that regulates fluid flow through the flow control device;

a seal member that at least partially surrounds the valve member, wherein the seal member extends radially outward and forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway;

an anchor member secured to the seal member, wherein the anchor member exerts a radial force against the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway and retains the flow control device in a fixed location in the bronchial passageway; and

a valve protector that at least partially surrounds the valve member, the valve protector having sufficient rigidity to maintain the shape of the valve member against compression,

wherein the seal member includes a cuff that defines a cavity, and wherein the cuff forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway and retains the flow control device in a fixed location in the bronchial passageway.

6. A flow control device as defined in claim 5, wherein the anchor member is retained within the cavity of the cuff of the seal member.

7. A flow control device as defined in claim 6, wherein at least one rivet attaches a first surface of the cuff to an opposed surface of the cuff to thereby retain the anchor member within the cavity.

8. A flow control device as defined in claim 6, wherein an adhesive attaches a first surface of the cuff to an opposed surface of the cuff to thereby retain the anchor member within the cavity.

9. A flow control device as defined in claim 6, wherein the anchor member is movable within the cavity of the cuff of the seal member.