Bronchial flow control devices with membrane seal

• US 7,798,147 B2
• Filed: 07/25/2003
• Issued: 09/21/2010
• Est. Priority Date: 03/02/2001
• Status: Active Grant

• Current Assignee: Pulmonx Corp.
• Original Assignee: Pulmonx Corp.
• Inventors: Hundertmark, Ronald, Wilsor, Peter, Fields, Antony J., Hendricksen, Michael
• Primary Examiner(s): Bianco; Patricia M
• Assistant Examiner(s): PATEL, NIHIR B
• Application Number:
  US10/627,941
• Publication Number:
  US 20040055606A1
• Time in Patent Office: 2,615 Days
• Field of Search: 128/200.26, 128/207.14, 128/207.15, 128/207.16, 128/200.24, 128/912, 623/1, 623/2, 623/9, 623/11, 623/12, 623/104, 623/900
• US Class Current: 128/207.14
• 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: Y10S 128/912 Connections and closures for tubes delivering fluids to or from the body

Abstract

Disclosed is a flow control device for a bronchial passageway. The device can includes a valve member that regulates fluid flow through the flow control device, a frame coupled to the valve member, and a membrane attached to the frame. At least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway. The membrane forms a fluid pathway from the seal into the valve member to direct fluid flowing through the bronchial passageway into the valve member.

Claims

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

a valve member that regulates fluid flow through the flow control device, the valve having a default shape;

a frame coupled to the valve member, the frame including;

a valve protector region that at least partially surrounds the valve member to maintain the default shape, wherein the valve protector region comprises a plurality of struts; and

a retainer region connected to the valve protector region, the retainer region being formed of a plurality of interconnected struts configured to engage an interior wall of the bronchial passageway to retain the flow control device in a fixed location therein, the retainer region being movable from a contracted state suitable for introduction into the bronchial passageway to an expanded state suitable for engaging the interior wall of the bronchial passageway; and

a membrane covering at least a portion of the retainer region, wherein at least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway, and wherein the membrane provides a fluid pathway from the seal to the valve member to direct fluid flowing through the bronchial passageway into the valve member.

2. A flow control device as defined in claim 1, wherein the membrane covers the entire retainer region of the frame.

3. A flow control device as defined in claim 1, wherein the membrane covers the retainer region of the frame and the valve protector region of the frame.

4. A flow control device as defined in claim 1, wherein the struts of the frame are arranged to form a plurality of cells, and wherein the cells are covered by the membrane.

5. A flow control device as defined in claim 1, wherein the frame comprises a superelastic material.

6. A flow control device as defined in claim 1, wherein the valve member limits fluid flow in an inhalation direction and permits fluid flow in the exhalation direction.

7. A flow control device as defined in claim 1, wherein the valve member blocks fluid flow in an inhalation direction and permits fluid flow in an exhalation direction.

8. A flow control device as defined in claim 1, wherein the valve member blocks fluid flow in both an inhalation direction and in an exhalation direction.

9. A flow control device as defined in claim 1, wherein the valve member comprises a duckbill valve having a pair of opposed walls having edges that form opposed lips of a mouth, wherein the walls can move with respect to one another to open and close the mouth.

10. A flow control device as defined in claim 9, wherein the lips of the mouth are curved.

11. A flow control device as defined in claim 9, wherein the lips of the mouth are straight.

12. A flow control device as defined in claim 9, wherein the opposed walls have domed outer surfaces.

13. A flow control device as defined in claim 9, wherein the opposed walls have flat outer surfaces.

14. A flow control device as defined in claim 9, wherein a flow channel is located between the lips of the valve mouth.

15. A flow control device as defined in claim 1, wherein the valve protector region comprises a tube.

16. A flow control device as defined in claim 15, wherein the tube has at least one window formed therein.

17. A flow control device as defined in claim 15, wherein the tube is non-expandable.

18. A flow control device as defined in claim 1, wherein the valve protector region is flexible.

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

20. A flow control device as defined in claim 1, wherein the valve protector region and the retainer region are formed from a single piece of material.

21. A flow control device as defined in claim 20, wherein the single piece of material comprises a tube.

22. A flow control device as defined in claim 1, wherein the valve protector region and the retainer region are composed of the same material.

23. A flow control device as defined in claim 22, wherein the material is metal.

24. A flow control device as defined in claim 22, wherein the material is superelastic.

25. A flow control device as defined in claim 1, wherein the struts of the retainer region form a series of undulating loops in the contracted state.

26. A flow control device as defined in claim 25, wherein the undulating loops form a series of zig-zags in the expanded state.

27. A flow control device as defined in claim 1, wherein the struts of the retainer region form at least two connected rows of undulating loops in the contracted state, the connected rows of undulating loops forming a series of diamond-shaped cells in the expanded state.

28. A flow control device as defined in claim 1, further comprising a plurality of linking struts connecting the valve protector region to the retainer region.

29. A flow control device as defined in claim 28, wherein the linking struts extend in a longitudinal direction from the valve protector region to the retainer region.

30. A flow control device as defined in claim 28, wherein the membrane secures the valve member to the frame.

31. A flow control device as defined in claim 28, wherein the linking struts are flexible.

32. A flow control device as defined in claim 28, wherein the linking struts and the retainer region are formed of the same material.

33. A flow control device as defined in claim 32, wherein the linking struts, retainer region and valve protector region are formed of the same material.

34. A flow control device as defined in claim 28, wherein valve protector region has a first diameter and the retainer region has a second diameter larger than the first diameter, the linking struts extending radially outwardly from the valve protector region to the retainer region.

35. A flow control device as defined in claim 34, wherein the linking struts are curved radially outwardly from the valve protector region to the retainer region.

36. A flow control device as defined in claim 28, wherein the struts of the retainer region form a plurality of zig-zags in the expanded state, each zig-zag having a proximal point and a distal point with a strut extending therebetween, each linking strut being connected to one of the proximal points.

37. A flow control device as defined in claim 28, wherein the struts of the retainer region form a plurality of zig-zags in the expanded sate, each zig-zag having a proximal point and a distal point with a strut extending therebetween, each linking strut being connected to one of the distal points.

38. A flow control device as defined in claim 1, wherein the frame comprises a second retainer region connected to the valve protector region.

39. A flow control device as defined in claim 38, wherein the retainer region is on a first side of the valve protector region and the second retainer region is on a second side of the valve protector region.

40. A flow control device as defined in claim 39, wherein the valve protector region has a diameter less than both of the retainer region and the second retainer region such that the frame has an hourglass-like shape.

41. A flow control device as defined in claim 38, wherein the membrane at least partially covers the second retainer region.

42. A flow control device as defined in claim 1, wherein the retainer region is self-expanding from the contracted state to the expanded state.

43. A flow control device as defined in claim 1, wherein the valve protector region is collapsible from a normal shape to a collapsed shape.

44. A flow control device as defined in claim 43, wherein the valve protector region is self-expandable from the collapsed shape to the normal shape.

45. A flow control device as defined in claim 1, wherein the valve member has a mouth that is movable between open and closed configurations, and wherein the valve protector comprises a loop extending around the mouth.

46. A flow control device as defined in claim 45, wherein the mouth has a pair of lips connected at two corners, the loop extending from one corner to the other corner to maintain the distance therebetween.

47. A flow control device as defined in claim 1, wherein membrane covers at least a portion of the valve protector.

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

a valve member that regulates fluid flow through the flow control device, the valve having a default shape;

a frame coupled to the valve member, the frame including;

a valve protector region that at least partially surrounds the valve member to maintain the default shape, wherein the valve protector region comprises a tube and the tube has at least one window formed therein; and

a retainer region connected to the valve protector region, the retainer region being formed of a plurality of interconnected struts configured to engage an interior wall of the bronchial passageway to retain the flow control device in a fixed location therein, the retainer region being movable from a contracted state suitable for introduction into the bronchial passageway to an expanded state suitable for engaging the interior wall of the bronchial passageway; and

a membrane covering at least a portion of the retainer region, wherein at least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway, and wherein the membrane provides a fluid pathway from the seal to the valve member to direct fluid flowing through the bronchial passageway into the valve member.

49. A flow control device as defined in claim 48, wherein the tube is non-expandable.

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

a valve member that regulates fluid flow through the flow control device, the valve having a default shape;

a frame coupled to the valve member, the frame including;

a valve protector region that at least partially surrounds the valve member to maintain the default shape;

a first retainer region connected to the valve protector region; and

a second retainer region connected to the valve protector region,

the first retainer region being formed of a plurality Of interconnected struts configured to engage an interior wall of the bronchial passageway to retain the flow control device in a fixed location therein, the first retainer region being movable from a contracted state suitable for introduction into the bronchial passageway to an expanded state suitable for engaging the interior wall of the bronchial passageway; and

a membrane covering at least a portion of the first retainer region, wherein at least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway, and wherein the membrane provides a fluid pathway from the seal to the valve member to direct fluid flowing through the bronchial passageway into the valve member.

51. A flow control device as defined in claim 50, wherein the first retainer region is on a first side of the valve protector region and the second retainer region is on a second side of the valve protector region.

52. A flow control device as defined in claim 51, wherein the valve protector region has a diameter less than both of the first retainer region and the second retainer region such that the frame has an hourglass-like shape.

53. A flow control device as defined in claim 50, wherein the membrane at least partially covers the second retainer region.

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

a valve member that regulates fluid flow through the flow control device, the valve having a default shape;

a frame coupled to the valve member, the frame including;

a valve protector region that at least partially surrounds the valve member to maintain the default shape, wherein the valve protector region is collapsible from a normal shape to a collapsed shape; and

a retainer region connected to the valve protector region, the retainer region being formed of a plurality of interconnected struts configured to engage an interior wall of the bronchial passageway to retain the flow control device in a fixed location therein, the retainer region being movable from a contracted state suitable for introduction into the bronchial passageway to an expanded state suitable for engaging the interior wall of the bronchial passageway; and

a membrane covering at least a portion of the retainer region, wherein at least a portion of the flow control device forms a seal with the interior wall of the bronchial passageway when the flow control device is implanted in the bronchial passageway, and wherein the membrane provides a fluid pathway from the seal to the valve member to direct fluid flowing through the bronchial passageway into the valve member.

55. A flow control device as defined in claim 54, wherein the valve protector region is self-expandable from the collapsed shape to the normal shape.