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

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.

1 - 118 . (canceled) 
     
     
         119 . A system comprising:
 (a) a guide catheter that is insertable into the head of the subject, wherein the guide catheter comprises:
 (i) a substantially rigid shaft, 
 (ii) a proximal opening, 
 (iii) a distal opening, and 
 (iv) a lumen extending between the proximal opening and the distal opening; 
   (b) a handle, wherein the handle is configured to couple with the guide catheter;   (c) a working catheter, wherein the working catheter comprises:
 (i) a substantially rigid proximal shaft portion, 
 (ii) a flexible distal shaft portion, and 
 (iii) a guidewire lumen, 
 wherein the working catheter is insertable through the lumen of the guide catheter to a position where some of the distal shaft portion but none of the substantially rigid proximal portion extends out of the distal end of the guide catheter and some of the substantially rigid proximal shaft portion but none of the distal shaft portion extends out of the proximal end of the guide catheter; 
   (d) a guidewire that is advanceable through the guidewire lumen; and   (e) a first member attached to the guidewire, wherein the first member is configured to facilitate grasping of the guidewire, wherein the first member is further configured to limit the extent to which the guidewire is advanceable through the guidewire lumen.   
     
     
         120 . The system of  claim 119 , 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. 
     
     
         121 . The system of  claim 120 , wherein the expandable dilator comprises a balloon. 
     
     
         122 . The system of  claim 121 , wherein the working catheter further comprises:
 (i) a inflation fluid lumen configured to communicate fluid to and from the balloon,   (ii) a proximal hub having an inflation port in communication with the inflation lumen, and   (iii) a guidewire port in communication with the guidewire lumen, wherein the inflation port is substantially perpendicular to said guidewire port.   
     
     
         123 . The system of  claim 122 , wherein the guidewire port is on the proximal end of the hub and the inflation port is on a side of the hub. 
     
     
         124 . The system of  claim 119 , 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 the expandable dilator is configured to cause dilation of the ostium. 
     
     
         125 . The system of  claim 124 , wherein the expandable dilator, when in its expanded state, has a diameter in the range of approximately 2.5 mm to approximately 10 mm. 
     
     
         126 . The system of  claim 119 , wherein the guidewire lumen has a lubricious coating or liner disposed therein. 
     
     
         127 . The system of  claim 119 , wherein the working catheter has an overall length of about 21 cm, wherein the substantially rigid proximal shaft portion of the working catheter is at least 12.5 cm in length. 
     
     
         128 . The system of  claim 119 , wherein the handle is sized and configured to be grasped by a single hand of an operator. 
     
     
         129 . The system of  claim 119 , further comprising a stabilization device that is attachable to the guide catheter, wherein the stabilization device is configured to facilitate control of the guide catheter and an endoscope by a single hand of an operator. 
     
     
         130 . The system of  claim 119 , 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. 
     
     
         131 . The system of  claim 119 , wherein the first member is configured to frictionally engage a hub on the working catheter. 
     
     
         132 . The system of  claim 119 , wherein at least a distal portion of the guide catheter is curved. 
     
     
         133 . The system of  claim 119 , wherein the distal shaft portion of the working catheter is configured to telescope out of the distal end of the guide catheter. 
     
     
         134 . The system of  claim 119 , further comprising a second member that is attachable to the working catheter, wherein the second member is configured to limit the extent to which the working catheter is advanceable through the guide catheter. 
     
     
         135 . The system of  claim 119 , wherein the handle defines a bore, wherein a portion of the handle is insertable into the proximal opening of the guide catheter such that the bore of the handle is in alignment with the lumen of the guide catheter. 
     
     
         136 . The system of  claim 135 , wherein the working catheter is insertable through the bore of the handle. 
     
     
         137 . A system comprising:
 (a) a guide catheter that is insertable into the head of the subject, wherein the guide catheter defines a working catheter lumen;   (b) a working catheter, wherein the working catheter defines a guidewire lumen, wherein the working catheter is insertable through the working catheter lumen of the guide catheter;   (d) a guidewire that is advanceable through the guidewire lumen of the working catheter; and   (e) a stop member attached to the guidewire, wherein the stop member is configured to facilitate grasping of the guidewire, wherein the stop member is further configured to limit the extent to which the guidewire is advanceable through the guidewire lumen of the working catheter.   
     
     
         138 . A system comprising:
 (a) a guide catheter that is insertable into the head of the subject, wherein the guide catheter defines a working catheter lumen, wherein a proximal portion of the guide catheter defines a longitudinal axis;   (b) a handle, wherein the handle is configured to couple with the guide catheter, wherein the handle defines a bore, wherein the working catheter lumen of the guide catheter is in alignment with the bore;   (c) a working catheter, wherein the working catheter defines a guidewire lumen, wherein the working catheter is insertable through the working catheter lumen of the guide catheter;   (d) a guidewire that is advanceable through the guidewire lumen; and   (e) a member attached to the guidewire, wherein the member is configured to facilitate grasping of the guidewire.