Systems and methods for transnasal dilation of passageways in the ear, nose and throat

• US 20080195041A1
• Filed: 04/24/2007
• Published: 08/14/2008
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Ha, Hung V., Muni, Ketan P., Kim, Isaac J., Facteau, William M., Goldfarb, Eric, Chang, John Y., Lam, Sivette
• Granted Patent: US 8,747,389 B2
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Devices, systems and methods useable for dilating the ostia of paranasal sinuses and/or other passageways within the ear, nose or throat. A dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator. Additionally, the dilation catheter device and system may be useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, an optional handle may be used to facilitate grasping or supporting a device of the present invention as well as another device (e.g., an endoscope) with a single hand.

Claims

1. A system for treating a disease or disorder of the ear, nose or throat of a human or animal subject, said system comprising:

a guide catheter that is insertable through a nostril of the subject, said guide catheter having a substantially rigid shaft, a proximal opening, a distal opening and a lumen extending between the proximal opening and the distal opening; and

a working catheter that is insertable through the lumen of the guide catheter, said working catheter having a substantially rigid proximal portion and a distal portion that is more flexible than the proximal portion;

the distal portion of the working catheter being advanceable out of the distal opening of the guide catheter and having a working element that is useable to perform a desired diagnostic or therapeutic task at a location within the ear, nose or throat of the subject;

the working catheter being sized relative to the guide catheter so that, when the distal portion of the working catheter is advanced out of the distal opening of the guide catheter and the working element is being used to perform the desired diagnostic or therapeutic task, only the substantially rigid proximal portion or some portion thereof will extend out of the proximal opening of the guide catheter.

2. A system according to claim 1 wherein the working catheter comprises dilation catheter and the working element comprises an expandable dilator that is positionable within a passageway of the ear, nose or throat and useable to dilate that passageway.

3. A system according to claim 2 wherein the expandable dilator comprises a balloon.

4. A system according to claim 2 wherein the expandable dilator is sized to be positioned within the ostium of a paranasal sinus while in a non-expanded state and to be thereafter expanded to an expanded state whereby it causes dilation of the ostium.

5. A system according to claim 4 wherein the working catheter is advanceable at least 2.5 cm beyond the distal end of the guide catheter.

6. A system according to claim 4 wherein the expandable dilator, when in its expanded state, has a diameter in the range of approximately 2.5 mm to approximately 10 mm.

7. A system according to claim 6 wherein the expandable dilator, when in its expanded state, has a diameter in the range of approximately 3.0 mm to approximately 7.0 mm.

8. A system according to claim 1 wherein the working catheter has an overall length of about 21 cm and wherein the substantially rigid proximal portion of the working catheter is at least 12.5 cm in length.

9. A system according to claim 1 wherein the distal portion of the working catheter is in the range between about 5 cm to about 9 cm in length.

10. A system according to claim 8 wherein the substantially rigid proximal portion of the working catheter is about 12.5 cm in length and the distal portion of the working catheter is about 8.7 cm in length.

11. A system according to any of claims 8, 9 or 10 wherein the distal portion of the working catheter includes a distal tip member that extends distal to the working element and is more flexible than the distal portion proximal to the working element.

12. A system according to claim 3 wherein the working catheter has a inflation fluid lumen through which inflation fluid passes into and out of the balloon and wherein that inflation fluid lumen is sized so that, after the balloon has been inflated to its working diameter, the balloon will deflate in less than about 15 seconds with application of negative pressure to the inflation fluid lumen by a conventional balloon catheter inflation and deflation device.

13. A system according to claim 3 wherein the working catheter has:

a inflation fluid lumen through which inflation fluid passes into and out of the balloon;

a guidewire lumen; and

a proximal hub having an inflation port in communication with the inflation lumen and a guidewire port in communication with the guidewire lumen, said inflation port is substantially perpendicular to said guidewire port.

14. A system according to claim 13 wherein the guidewire port is on the proximal end of the hub and the inflation port is on a side of the hub.

15. A system according to claim 1 wherein the working catheter has a guidewire lumen.

16. A system according to claim 15 wherein the guidewire lumen has a lubricious coating or liner disposed therein.

17. A system according to claim 15 wherein the guidewire lumen is coated with a silicone coating.

18. A system according to claim 1 further in combination with a handle that is attachable to the guide catheter.

19. A system according to claim 18 wherein the handle is graspable, along with another device, by a single hand of an operator.

20. A system according to claim 19 wherein the handle is graspable, along with an endoscope, by a single hand of an operator.

21. A system according to claim 1 further in combination with a stabilization device that is attachable to the guide catheter, said stabilization device facilitating control of the guide catheter and endoscope by a single hand of an operator.

22. A system according to claim 18 wherein at least a portion of the handle is shapeable so that it may be deformed to a desired bend or shape by the operator.

23. A system according to claim 15 further in combination with a guidewire that is advanceable through the guidewire lumen.

24. A system according to claim 23 further comprising a member that is attachable to the guidewire and limits the extent to which the guidewire is advanceable through the working catheter.

25. A system according to claim 1 further comprising a member that is attachable to the guidewire and is handled by the operator to advance, retract and twist the guidewire.

26. A system according to claim 24 wherein the member is configured such that the guidewire may be advanced until the member engages the working catheter, said engagement of the member with the working catheter being operative to hold the guidewire in a substantially fixed position relative to the working catheter.

27. A system according to claim 26 wherein the member frictionally engages a hub on the working catheter.

28. A system according to claim 1 wherein the distal portion is flexible.

29. A system according to claim 1 wherein the guide catheter is curved.

30. A system according to claim 1 wherein a distal portion of the guide catheter is curved.

31. A system according to claim 29 wherein the guide catheter has a curve in the range of 30 degrees to 110 degrees.

32. A system according to claim 1 wherein the distal portion of the working catheter telescopes out the distal end of the guide catheter.

33. A system according to claim 24 further comprising a second member that member that is attachable to the working catheter and limits the extent to which the working catheter is advanceable through the guide catheter.

34. A system according to claim 33 wherein the member frictionally engages a hub on the working catheter and the second member frictionally engages a hub on the guide catheter.

35. A system according to claim 33 wherein the second member is permanently attached to the working catheter.

36. A system according to claim 24 wherein the member is permanently attached to the guide catheter.

37. A dilation catheter device useable for dilating the ostium of a paranasal sinus, said device comprising:

a catheter shaft having a longitudinal axis, an inflation lumen, a distal end and a proximal end;

a inflatable dilator on said catheter shaft, said inflatable dilator being connected to the inflation lumen such that inflation fluid may be passed through the inflation lumen to inflate the inflatable dilator; and

a hub on the proximal end of the catheter shaft, said hub having a longitudinal axis and a sidearm that is connected to the inflation lumen such that an inflator may be attached to the sidearm and used to deliver inflation fluid through the inflation lumen;

wherein said sidearm extends substantially perpendicular to the longitudinal axis of the hubs.

38. A dilation catheter device according to claim 37 further comprising:

a second lumen extending through the catheter shaft; and

a proximal port on the proximal end of the hub in communication with the second lumen.

39. A dilation catheter device according to claim 38 wherein the second lumen has an opening at the distal end of the catheter shaft and is useable as a guidewire lumen for over-the-wire advancement of the catheter device.

40. A dilation catheter device according to claim 37 wherein the catheter shaft has a proximal portion and a distal portion, the proximal portion of the catheter shaft being less flexible than the distal portion.

41. A dilation catheter device according to claim 40 wherein the proximal portion of the catheter shaft has a length of approximately 10-15 cm and the distal portion of the catheter shaft has a length of approximately 6-8 cm.

42. A dilation catheter device according to claim 40 wherein the proximal portion of the catheter shaft has a length of approximately 13 cm and the distal portion of the catheter shaft has a length of approximately 7 cm.

43. A system comprising a dilation catheter device according to claim 39 further in combination with a guidewire that is passable through the second lumen.

44. A system according to claim 43 wherein the dilation catheter device has a length of from about 18 cm to about 21 cm and the guidewire has a length of from about 37 cm to about 85 cm.

45. A system according to claim 44 further comprising a member that is attachable to the guidewire and limits the extent to which the guidewire is advanceable through the dilation catheter.

46. A system according to claim 44 further comprising a member that is attachable to the guidewire and is handled by the operator to advance, retract and twist the guidewire.

47. A system according to claim 45 wherein the member is configured such that the guidewire may be advanced until the member engages the dilation catheter, said engagement of the member with the dilation catheter being operative to hold the guidewire in a substantially fixed position relative to the dilation catheter.

48. A system according to claim 47 wherein the member frictionally engages a hub on the dilation catheter.

49. A system comprising a dilation catheter device according to claim 37 in combination with a guide catheter that is insertable into the subject'"'"'s nose, said guide catheter having a lumen through which the dilation catheter device is advanceable.

50. A system according to claim 37 further in combination with a handle that is attachable to the guide catheter.

51. A system according to claim 50 wherein the handle is graspable, along with another device, by a single hand of an operator.

52. A system according to claim 50 wherein the handle is graspable, along with an endoscope, by a single hand of an operator.

53. A system according to claim 50 wherein at least a portion of the handle is shapeable so that it may be deformed to a desired bend or shape by the operator.

54. A system according to claim 49 wherein the guide catheter is curved.

55. A system according to claim 54 wherein a distal portion of the guide catheter is curved.

56. A system according to claim 54 wherein the guide catheter has a curve in the range of 30 degrees to 110 degrees.

62. A system comprising a dilation catheter device according to claim 37 further in combination with a guidewire that is passable through the second lumen.

63. A system according to claim 62 wherein the dilation catheter device has a length of from about 18 cm to about 21 cm and the guidewire has a length of from about 37 cm to about 85 cm.

64. A system according to claim 63 further comprising a member that is attachable to the guidewire and limits, the extent to which the guidewire is advanceable through the dilation catheter.

65. A system according to claim 64 wherein the member is configured such that the guidewire may be advanced until the member engages the dilation catheter, said engagement of the member with the dilation catheter being operative to hold the guidewire in a substantially fixed position relative to the dilation catheter.

66. A system according to claim 63 wherein the member frictionally engages a hub on the dilation catheter.

67. A system comprising a dilation catheter device according to claim 37 in combination with a guide catheter through which the dilation catheter may be advanced.

68. A system according to claim 67 wherein the dilation catheter has at least one shaft marking that indicates the longitudinal position of the dilation catheter within the guide catheter.

69. A system according to claim 67 wherein the guide catheter has a curve and the dilation catheter has a shaft marking that indicates to the operator when the dilation catheter has been advanced to a position where the distal end of the dilation catheter is slightly proximal to the curve of the guide catheter.

70. A system according to claim 67 wherein the guide catheter has a distal end, the dilator has a distal end and the dilation catheter has a shaft marking that indicates when the distal end of the dilator is substantially flush with the distal end of the guide catheter.

71. A system according to claim 67 wherein the guide catheter has a distal end and the dilation catheter has a shaft marking that indicates to the operator when the dilation catheter has been advanced to a position where the entire dilator is beyond the distal end of the guide catheter.

72. A system according to claim 67 wherein the guide catheter is substantially rigid and wherein the dilation catheter is sized relative to the guide catheter such that the dilation catheter may be inserted into the guide catheter to a first position where only some or all of the substantially rigid proximal portion extends out of the proximal end of the guide catheter and none of the distal shaft section extends out of the distal end of the guide catheter.

73. A system according to claim 72 wherein the dilation catheter is further advanceable to a second position where dilator is advanced out of the distal end of the guide catheter.

74. A system according to claim 73 wherein the guide catheter has a curved region formed therein and wherein the dilation catheter is sized such that it may be advanced to said second position without requiring the substantially rigid proximal shaft section of the dilation catheter to advance through the curved region of the guide catheter.

75. A system according to claim 67 further in combination with a handle that is attachable to the guide catheter, said handle being graspable, along with an endoscope, by a single hand of an operator.

76. A system according to claim 75 wherein at least a portion of the handle is shapeable so that it may be deformed to a desired bend or shape by the operator.

77. A dilation catheter device according to claim 37 further comprising an endoscopically visible marker on or adjacent to a proximal end of the dilator.

78. A system comprising a dilation catheter according to claim 37 in combination with:

a guide catheter through which the dilation catheter is advanceable.

79. A system according to claim 78 further comprising:

a member that is attachable to the guidewire and limits the extent to which the guidewire is advanceable through the dilation catheter.

80. A system according to claim 79 further comprising:

a second member that is attachable to the dilation catheter and limits the extent to which the dilation catheter is advanceable through the guide catheter.

57. A sinus ostium dilation catheter device comprising:

an elongate catheter shaft having a proximal end, a distal end, a proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section, wherein the proximal shaft section extends along at least about 50% of the overall length of the device;

a guidewire lumen extending through at least a portion of the catheter shaft to facilitate advancement of the catheter over a guidewire; and

a dilator located on the distal shaft section, said dilator having a non-expanded configuration and an expanded configuration.

58. A dilation catheter device according to claim 57 wherein the dilator comprises a balloon and wherein the device further comprises:

an inflation/deflation lumen extending through the catheter shaft for passage of inflation fluid into and out of the balloon.

59. A dilation catheter device according to claim 58 further comprising:

a hub on the proximal end of the catheter shaft, said hub having a longitudinal axis, a guidewire port that is substantially coaxial with the longitudinal axis and is in communication with the guidewire lumen and an inflation/deflation port that is substantially perpendicular to the longitudinal axis and is in communication with the inflation/deflation lumen.

60. A dilation catheter device according to claim 57 wherein the proximal shaft section has a length of approximately 10 cm-15 cm and the distal shaft section has a length of approximately 6 cm-8 cm.

61. A dilation catheter device according to claim 60 wherein the proximal shaft section has a length of approximately 13 cm and the distal shaft section has a length of approximately 7 cm.

81. A method for dilating a passageway within the ear, nose or throat of a human or animal subject, said method comprising the steps of:

A) inserting a guide catheter having a proximal end and a distal end through one of the subject'"'"'s nostrils and positioning the guide catheter within or near the passageway to be dilated;

B) inserting, through the guide catheter, a dilation catheter comprising i) an elongate catheter shaft having a proximal end, a distal end, a proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section, ii) a guidewire lumen extending through at least a portion of the catheter shaft to facilitate advancement of the catheter over a guidewire and iii) a dilator located on the distal shaft section, said dilator being in a non-expanded configuration;

C) positioning the dilator within the passageway; and

D) causing the dilator to expand to an expanded configuration, thereby dilating the passageway.

82. A method according to claim 81 wherein the passageway is an ostium of a paranasal sinus.

83. A method according to claim 81 wherein the guide catheter is substantially rigid and, during the performance of at least a portion of the method, the dilation catheter is inserted to a position where only the substantially rigid proximal shaft section of the dilation catheter extends out of the proximal end of the guide catheter.

84. A method according to claim 83 wherein, during at least a portion of the method, the operator uses a single hand to grasp or support the guide catheter as well as a portion of the substantially rigid proximal shaft section of the dilation catheter that extends out of the proximal end of the guide catheter.

85. A method according to claim 81 further comprising the step of:

inserting a guidewire through the guide catheter; and

wherein, during performance of Step B, the dilation catheter is advanced over the guidewire and through the guide catheter.

86. A method according to claim 85 wherein the guidewire is inserted through the guide catheter after Step A has been performed and wherein Step B comprises inserting a proximal end of the guidewire into the guidewire lumen of the dilation catheter and then advancing the dilation catheter over the guidewire and through the guide catheter.

87. A method according to claim 85 wherein:

the dilation catheter is pre-inserted into the guide catheter;

the guide catheter, having the dilation catheter pre-inserted therein, is then inserted through one of the subject'"'"'s nostrils and positioned within or near the passageway to be dilated;

the guidewire is inserted into the guidewire lumen of the dilation catheter and is advanced though the guidewire lumen of the dilation catheter, out of the distal end of the guide catheter and into or through the passageway to be dilated; and

the dilation catheter is then advanced over the guidewire to the position where the dilator is within the passageway.

88. A method according to claim 81 further comprising the steps of:

returning the dilator to a non-expanded configuration; and

removing the dilation catheter and guide catheter from the subject'"'"'s body.

89. A method according to claim 81 further comprising the steps of:

returning the dilator to a non-expanded configuration;

retracting the dilation catheter into the guide catheter; and

thereafter removing the dilation catheter and guide catheter from the subject'"'"'s body.

90. A method according to claim 81 wherein the method is carried out prior to performance of functional endoscopic sinus surgery.

91. A method according to claim 81 wherein the method is carried out a plurality of times to dilate ostia of a plurality of different paranasal sinuses.

92. A method according to claim 91 wherein the method is carried out a first time to dilate the ostium of a sphenoid sinus, a second time to dilate the ostium of a frontal sinus and a third time to dilate the ostium of a maxillary sinus.

93. A method according to either of claims 91 or 92 wherein the same guidewire is used during all of the ostia dilations.

94. A method according to either of claims 91 or 92 wherein a different guide catheter is used during each ostium dilation.

95. A method according to claim 94 wherein the different guide catheters have different curves formed therein to facilitate accessing of each ostium.

96. A method according to either of claims 91 or 92 wherein the same guide catheter is used during all of the ostia dilations.

97. A method according to claim 96 wherein the guide catheter is malleable and wherein the method further comprises the step of:

modifying the shape of the guide catheter to facilitate accessing of each ostium.

98. A method according to claim 81 further comprising the step of:

using an endoscope to view at least a portion of the method.

99. A method according to either of claims 81 or 98 further comprising the step of:

using an fluoroscope to view at least a portion of the method.

100. A method according to claim 99 wherein the fluoroscope is mounted on a moveable assembly and wherein the method further comprises the step of:

moving the moveable assembly to adjust the vantage point of the fluoroscope.

101. A method according to claim 100 wherein the moveable assembly comprises a C arm and wherein the step of moving the moveable assembly comprises moving the C arm.

102. A method according to claim 85 wherein:

the guidewire is pre-inserted into the dilation catheter;

the dilation catheter, having the guidewire pre-inserted therein, is pre-inserted into the guide catheter; and

the guide catheter, having the dilation catheter and guidewire pre-inserted therein, is then inserted through one of the subject'"'"'s nostrils and positioned within or near the passageway to be dilated;

the guidewire is then advanced into or through the passageway to be dilated; and

the dilation catheter is then advanced over the guidewire to the position where the dilatior is within the passageway.

103. A method according to claim 81 wherein the dilator comprises a balloon and wherein Step D comprises inflating the balloon.

104. A method according to claim 89 wherein the dilation catheter further comprises a hub on the proximal end of the catheter shaft, said hub having a longitudinal axis, a guidewire port that is substantially coaxial with the longitudinal axis, an inflation/deflation port that is substantially perpendicular to the longitudinal axis and wherein:

the guidewire is inserted through the guidewire port;

an inflator is attached to the inflation/deflation port; and

Step D comprises using the inflator to inflate the balloon.

105. A method according to claim 104 wherein the inflator is a foot-actuated inflator and wherein Step D comprises foot-actuating the inflator to cause inflation of the balloon.

106. A method according to claim 81 wherein dilation catheter has a first shaft marking that indicates when the dilation catheter has been advanced to a first position where the distal end of the dilation catheter is just proximal to a specific region of the guide catheter and wherein the method comprises:

initially advancing the dilation catheter until the first shaft marking indicates that the dilation catheter is in said first position.

107. A method according to claim 106 wherein not advancing the dilation catheter beyond the first position results in less friction on the guidewire as the guidewire is manipulated from the proximal end of the dilation catheter than if the dilation catheter were advanced substantially beyond the first position.

108. A method according to claim 107 wherein the dilation catheter has not begun to navigate a curve in the guide catheter when in the first position.

109. A method according to claim 106 wherein the guide catheter has a second shaft marking that indicates when the entire dilator is beyond the distal end of the guide catheter and wherein the method further comprises:

subsequently advancing the dilation catheter until the second shaft marking indicates that the dilation catheter is in said second position.

110. A method according to claim 106 wherein the guide catheter is rigid and, when the dilation catheter has been advanced to said first position, only all or some of the substantially rigid proximal portion extends out of the proximal end of the guide catheter and, during at least part of the time while the dilation catheter is in said first position, the operator uses a single hand to hold or support the guide catheter and the portion of the dilation catheter that extends out of the proximal end of the dilation catheter.

111. A method according to claim 106 wherein the guide catheter has a second shaft marking that indicates when the entire dilator has been advanced beyond the distal end of the guide catheter and wherein the method further comprises:

using the same hand to advance the dilation catheter until the second shaft marking indicates that the dilation catheter is in said second position.

112. A method according to claim 81 further comprising the step of:

inserting an endoscope through the nostril and using the endoscope to view at least a portion of the procedure.

113. A method according to claim 112 wherein, during at least part of the method, the operator holds the guide catheter and endoscope with a single hand.

114. A method according to claim 112 wherein, during at least part of the method, the operator holds the guide catheter, dilation catheter and endoscope with a single hand.

115. A method according to claim 112, 113 or 114 wherein a handle is attached to the guide catheter and, during at least part of the method, the operator grasps the endoscope and said handle with a single hand.

116. A method according to claim 115 wherein the handle is shapeable and wherein the method further comprises the step of shaping the handle.

117. A method according to any of claims 85-88 wherein a stop member is positioned on the guidewire to limit the extent to which the guidewire may be advanced into the subject'"'"'s body and wherein the guidewire is advanced until said stop member prevents further advancement of the guidewire.

118. A method according to any of claims 85-88 wherein a stop/connector member is positioned on the guidewire, said stop/connector member being operative to abutting against and engages proximal end of the dilation catheter so as to thereby prevent further advancement of the guidewire and hold the guidewire in substantially fixed position relative to the dilation catheter and wherein the guidewire is advanced until said stop/connector member prevents further advancement of the guidewire and holds the guidewire in substantially fixed position relative to the dilation catheter.