Bronchial flow control devices and methods of use

• US 20030070682A1
• Filed: 10/10/2002
• Published: 04/17/2003
• Est. Priority Date: 10/11/2001
• Status: Active Grant

• Current Assignee: Pulmonx Corp.
• Original Assignee: Emphasys Medical, Inc. (Pulmonx Corp.)
• Inventors: Hendricksen, Michael J., Gifford, Hanson S. III, Fields, Antony J., Hundertmark, Ronald, Barrett, Michael S., Tholfsen, David R., Rapacki, Alan R., McCutcheon, John G., Wilson, Peter M., Sutton, Douglas
• Granted Patent: US 6,941,950 B2
• Time in Patent Office: Days
• US Class Current: 128/207.16
• 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.

2. A flow control device as defined in claim 1, additionally comprising a valve protector comprising an annular wall that at least partially surrounds the valve member.

3. A flow control device as defined in claim 1, 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.

4. A flow control device as defined in claim 3, 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.

5. A flow control device as defined in claim 4, wherein the first radial distance is different from the second radial distance.

6. A flow control device as defined in claim 3, wherein the flange is oriented at an angle with respect to the longitudinal axis.

7. A flow control device as defined in claim 1, 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.

8. A flow control device as defined in claim 7, wherein the anchor member is retained within the cavity of the cuff of the seal member.

9. A flow control device as defined in claim 8, 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.

10. A flow control device as defined in claim 8, 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.

11. A flow control device as defined in claim 8, wherein the anchor member is movable within the cavity of the cuff of the seal member.

12. 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.

13. A flow control device as defined in claim 12, wherein the valve member comprises a duckbill valve.

14. A flow control device as defined in claim 12, wherein the valve member comprises a flap valve.

15. A flow control device as defined in claim 1, wherein the valve member regulates fluid flow through the flow control device valve member by preventing fluid from flowing in any direction through the flow control device.

16. A flow control device as defined in claim 15, wherein the valve member comprises a septum.

17. A flow control device as defined in claim 16, wherein septum includes a slit, and wherein the slit can be pierced by a dilator device that provides a fluid passageway through the valve member.

18. A flow control device as defined in claim 1, wherein the valve member opens at a first cracking pressure to permit fluid to flow through the flow control device in a first direction, and wherein the valve member opens at a second cracking pressure to permit fluid to flow through the flow control device in a second direction.

19. A flow control device as defined in claim 2, 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.

20. A flow control device as defined in claim 2, wherein the valve protector member is manufactured of a super-elastic material.

21. A flow control device as defined in claim 2, wherein the valve protector member is rigid.

22. 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 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.

23. A flow control device as defined in claim 22, 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.

24. 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.

25. A flow control device as defined in claim 24, wherein the anchor member can expand and contract independently of the valve member, and seal member.

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

27. A flow control device as defined in claim 1, wherein the anchor member does not surround any portion of the seal member.

28. A flow control device as defined in claim 2, wherein the valve protector entirely surrounds the valve member.

29. A flow control device as defined in claim 2, wherein the valve protector only partially surrounds the valve member.

30. A flow control device as defined in claim 1, additionally comprising an additional valve member that regulates fluid flow through the flow control device.

31. A flow control device as defined in claim 30, wherein the valve member opens at a first cracking pressure to permit fluid to flow through the fluid flow device in a first direction, and the additional valve member opens at a second cracking pressure to permit fluid to flow through the fluid flow device in a second direction.

32. A flow control device as defined in claim 1, wherein the valve member can be dilated by a dilation device that can be inserted through the valve member such that the dilation device provides a fluid passageway through the valve member.

33. A flow control device as defined in claim 32, wherein the valve member provides a seal around a perimeter of the dilation device when the dilation device is inserted through the valve member.

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

35. A system for delivering a flow control device into a bronchial passageway, comprising:

a catheter having a proximal end and a distal end, the catheter sized to be deployed to a target location of a bronchial passageway through a trachea;

a housing at or near the distal end of the catheter, the housing defining an interior cavity that is sized to at least partially receive the flow control device;

an ejection member that is movably positioned in the housing, the ejection member being adapted so that it can eject the flow control device out of the housing when the flow control device is located in the housing;

an actuation member attached to the catheter and mechanically coupled to the ejection member such that the actuation member can be actuated to cause the ejection member to move within the housing and eject a flow control device from the housing.

36. A system as defined in claim 35, wherein the catheter includes an elongate tip region distally located from the housing, the tip region having a rounded distal surface.

37. A system as defined in claim 36, wherein the tip region comprises a soft material.

39. A system as defined in claim 37, wherein the tip region of the catheter comprises a flexible wire.

40. A system as defined in claim 35, wherein a central guide wire lumen extends through the length of the catheter, the guide wire lumen being sized to receive a guide wire that can be used during deployment of the catheter to guide the catheter to the target location of the bronchial passageway.

41. A system as defined in claim 35, wherein the catheter includes a tip region distally located from the housing, and wherein the tip region includes an elongate protrusion that provides the tip region with an asymmetric shape with respect to a longitudinal axis of the catheter.

42. A system as defined in claim 41, wherein the elongate protrusion is compressively compliant so that the elongate protrusion can be compressed in size.

43. A system as defined in claim 42, wherein a distal portion of the catheter is curved, and wherein the distal portion of the catheter curves within a plane containing the protrusion.

44. A system as defined in claim 35, wherein the catheter has a bending stiffness, and wherein the bending stiffness of the catheter differs at various locations of the catheter.

45. A system as defined in claim 44, wherein a distal portion of the catheter has a bending stiffness that is less than the bending stiffness of a proximal portion of the catheter.

46. A system as defined in claim 35, wherein the catheter includes an outer member and an inner member that is slidably contained within the outer member.

47. A system as defined in claim 46, wherein the housing is attached to a distal end of the outer member, and wherein a distal end of the inner member protrudes through the housing and can be slidably moved relative to the housing.

48. A system as defined in claim 47, wherein the ejection member comprises a flange that is attached to the distal end of the inner member.

49. A system as defined in claim 46, wherein the actuation member comprises a handle having a first handle piece that is attached to a proximal end of the outer member and a second handle piece that is attached to a proximal end of the inner member, and wherein the first handle piece can be moved relative to the second handle piece to move the ejection member relative to the housing.

50. A system as defined in claim 46, wherein the actuation member comprises a handle having a first handle piece that is attached to a proximal end of the outer member and a second handle piece that is attached to a proximal end of the inner member, and wherein the first handle piece can be moved relative to the second handle piece to move the housing relative to the ejection member.

51. A system as defined in claim 35, wherein the interior cavity of the housing is sized to receive the entire flow control device.

52. A system as defined in claim 35, wherein the interior cavity of the housing is sized to receive just a portion of the flow control device so that a distal edge of the flow control device protrudes from the housing when the flow control device is located in the housing.

53. A system as defined in claim 35, wherein the interior cavity of the housing has a shape that substantially corresponds to the shape of the flow control device that will be inserted into the housing.

54. A system as defined in claim 35, additionally comprising a pull wire, wherein a distal end of the pull wire is attached to a distal end of the catheter, and wherein a proximal end of the pull wire can be pulled to deflect the distal end of the catheter.

55. A system as defined in claim 35, wherein a distal region of the catheter is more flexible than other regions of the catheter.

56. A system as defined in claim 35, wherein a distal portion of the delivery catheter is curved, and wherein the distal portion of the catheter curves within a plane containing the protrusion.

38. A system as defined in claim 38, wherein the soft material comprises Pebax, silicone, or urethrane.

57. A system for delivering a flow control device into a bronchial passageway, comprising:

a catheter having a proximal end and a distal end, the catheter sized to be deployed to a target location of a bronchial passageway through a trachea, wherein the catheter includes a tip region distally located from the housing and wherein the tip region is deformed into a bent shape; and

a housing at or near the distal end of the catheter, the housing defining an interior cavity that is sized to at least partially receive the flow control device.

58. A system as defined in claim 57, wherein the tip region of the catheter is bent into a “

J”

shape.

59. A system as defined in claim 57, wherein the catheter includes a lumen that is sized to receive a mandrel, and wherein the catheter can conform to the shape of the mandrel when the mandrel is inserted into the lumen.

60. A system as defined in claim 59, wherein the tip region is elastic so that the distal region automatically returns to the bent shape after the shape of the distal region is disturbed.

61. A system for loading a flow control device onto a delivery catheter, comprising:

a loader device having a loading tunnel sized to receive the flow control device, wherein the loader device can provide a compressing force to the flow control device when the flow control device is positioned in the loading tunnel to compress the flow control device to a size that fits within the delivery catheter;

a first piston that slidably fits within the loading tunnel of the loader device, wherein the first piston can be inserted into the loading tunnel to eject a compressed flow control device from the loading tunnel into the delivery catheter.

62. A system as defined in claim 61, wherein the loader device can provide a compressing force that is equally balanced around the perimeter of a flow control device positioned in the loading tunnel.

63. A system as defined in claim 61, wherein the loader device comprises a main body, and wherein the loading tunnel forms a front opening and a rear opening in the main body, and wherein the front opening is sized to receive the flow control device and the rear opening is sized to receive a distal end of the catheter.

64. A system as defined in claim 63, wherein the loading tunnel includes a funnel-shaped loading region located adjacent the front opening, wherein the funnel-shaped loading region gradually reduces from a first size to a second size moving from the front opening toward the rear opening such that the flow control device can be pushed through the funnel region to thereby compress the size of the flow control device.

65. A system as defined in claim 64, wherein the loading tunnel includes a housing region that is sized to receive a housing of the catheter, wherein the housing can be fixedly positioned in the housing region of the loading tunnel such that the housing is positioned to receive the flow control device from the funnel-shaped region of the loading tunnel.

66. A system as defined in claim 65, wherein the loader device includes a locking mechanism that locks a catheter into the loading device with the catheter positioned to receive a flow control device from the loading tunnel.

67. A system as defined in claim 66, wherein the locking mechanism comprises a movable door that at least partially blocks the rear opening of the tunnel, the movable door being movable from an open position to a closed position, and wherein a catheter housing can be inserted through the rear opening when the door is in the open position, but the catheter housing cannot be inserted through the rear opening when the door is in the closed position.

68. A system as defined in claim 61, wherein the first piston has at least one groove that mates with a corresponding groove in a wall of the loading tunnel.

69. A system as defined in claim 61, additionally comprising a second piston that slidably fits within the loading shaft, wherein the second piston is sized to push the flow control device a first distance into the loading tunnel.

70. A system as defined in claim 69, wherein the first piston and second piston are attached to one another.

71. A system as defined in claim 61, wherein the loader device has a first handle and a second handle, wherein the first handle is movable with respect to the second handle, and wherein the loader device includes one or more cams that form the size of the loading tunnel, the cams being movably coupled to the first handle and second handle such that the size of the loading tunnel reduces when the first handle is moved toward the second handle.

72. A system as defined in claim 71, wherein the first handle is rotatably movable with respect to the second handle.

73. A system as defined in claim 71, wherein a lever attaches the first piston to the loader device such that the lever can be moved to slide the piston through the tunnel.

74. A method of deploying a flow control device in a bronchial passageway, comprising:

identifying a target location in a bronchial passageway to which the flow control device will be deployed;

providing a delivery catheter having a flow control device loaded therein, wherein the flow control device is loaded into a housing located at a distal end of the delivery catheter, and wherein the delivery catheter includes an ejector member that is positioned in the housing, the ejection member coupled to an actuator that is actuated to cause the ejection member to eject the flow control device out of the housing;

positioning the delivery catheter within the bronchial passageway so that the housing is positioned at the target location in the bronchial passageway;

ejecting the flow control device from the housing to deploy the flow control device in the bronchial passageway.

75. A method as defined in claim 74, additionally comprising removing the delivery device from the bronchial passageway.

76. A method as defined in claim 74, additionally comprising identifying a targeted lung region that is supplied air through the bronchial passageway.

77. A method as defined in claim 74, additionally comprising:

determining the internal diameter of the target location in the bronchial passageway; and

selecting a flow control device for deploying in the lumen of the bronchial passageway based on the internal diameter of the target location in the bronchial passageway.

78. A method as defined in claim 74, additionally comprising loading the flow control device into the housing of the delivery catheter.

79. A method as defined in claim 74, wherein the flow control device is deployed in the bronchial passageway so that the flow control device prevents air from flowing through the bronchial passageway in an inhalation direction.

80. A method as defined in claim 74, wherein the flow control device is deployed in the bronchial passageway so that the flow control device prevents air from flowing through the bronchial passageway in an inhalation direction and prevents air from flowing through the bronchial passageway in an exhalation direction.

81. A method as defined in claim 74, additionally comprising:

inserting a dilator device into the bronchial passageway, the dilator device having an internal fluid passageway and a proximal end and a distal end;

inserting the dilator device through the flow control device so that a distal end of the dilator device is located distally of a valve member of the flow control device in the bronchial passageway and a proximal end of the dilator device is located proximally of the valve member of the flow control device, wherein the dilator device provides a fluid passageway through the flow control device.

82. A method as defined in claim 81, wherein the proximal end of the dilator device includes a one-way valve that permits fluid flow through the dilator device in an exhalation direction but prevents fluid flow through the dilator device in an inhalation direction.

83. A method as defined in claim 81, additionally comprising removing the dilator device from the flow control device by pulling on a tether that is attached to the dilator device, while maintaining the flow control device in the bronchial passageway.

84. A method as defined in claim 81, wherein the proximal end of the fluid passageway of the dilator device fluidly communicates with the internal lumen of a catheter that extends in a proximal direction through the bronchial passageway.

85. A method as defined in claim 84, wherein the catheter has at least one vent hole that communicates with the internal lumen of the catheter, and wherein the vent hole is located in a region of the catheter that is positioned in the bronchial passageway proximally of the valve member of the dilator device.

86. A method as defined in claim 81, additionally comprising:

using the dilator device to aspirate fluid from a location of the bronchial passageway distal of the flow control device.

87. A method as defined in claim 81, additionally comprising applying a suction through the dilator device to a location of the bronchial passageway distal of the flow control device.

88. A method as defined in claim 87, wherein the suction causes a region of the lung that is isolated by the flow control device to collapse.

89. A method as defined in claim 81, additionally comprising instilling a material through the dilator device to a location of the bronchial passageway distal of the flow control device.

90. A method as defined in claim 89, wherein the material comprises Oxygen.

91. A method as defined in claim 89, wherein the material comprises a brachytherapy source.

92. A method as defined in claim 81, additionally comprising aspirating air from a lung region that is isolated by the flow control device.

93. A method as defined in claim 81, additionally comprising aspirating air from a lung region that is isolated by the flow control device using a vacuum source that is coupled to the dilator device.

94. A method as defined in claim 81, wherein the proximal end of the dilator device protrudes outward of a mouth of a patient.

95. A method as defined in claim 74, additionally comprising performing one or more procedures to a lung region that is bronchially isolated by the flow control device in order to collapse the lung region.

96. A method as defined in claim 74, additionally comprising coating the flow control device with a drug.

97. A method as defined in claim 74, additionally comprising:

inserting a bronchoscope into the bronchial passageway such that a distal end of the bronchoscope is located in a bronchial passageway that is at least one bronchial generation proximal of the bronchial passageway where the target location is located; and

positioning the delivery catheter within the bronchial passageway by inserting the delivery catheter through a working channel of the bronchoscope.

98. A method as defined in claim 74, additionally comprising:

inserting the delivery catheter through a working channel of a bronchoscope;

inserting a bronchoscope into the bronchial passageway after inserting the delivery catheter through the working channel of the bronchoscope, such that a distal end of the bronchoscope is located near the target location in the bronchial passageway and such that the housing of the delivery catheter protrudes through the distal end of the bronchoscope.

99. A method as defined in claim 74, additionally comprising:

inserting a guidewire into the bronchial passageway such that a distal end of the guidewire is located near the target location in the bronchial passageway;

positioning the delivery catheter within the bronchial passageway by inserting the delivery catheter over the guide wire.

100. A method as defined in claim 74, wherein ejecting the flow control device from the housing to deploy the flow control device in the bronchial passageway comprises controlling an actuator that causes the ejection member to push the flow control device out of the housing.

101. A method as defined in claim 74, wherein ejecting the flow control device from the housing to deploy the flow control device in the bronchial passageway comprises moving the housing in a proximal direction while maintaining the flow control device in a fixed position so that the housing withdraws from the flow control device.

102. A method as defined in claim 74, wherein the flow control device comprises:

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

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

an anchor member attached to the seal member, wherein the anchor member exerts a radial force against an interior wall of a bronchial passageway when the flow control device is implanted in a bronchial passageway to retain the flow control device in a fixed location in the bronchial passageway.