Systems and methods for sinus access

Abstract

This application is generally related to systems and methods for accessing the paranasal sinuses and other passages of the nose, ear, and throat. The systems and methods generally employ devices capable of maintaining a fixed handle orientation with respect to the patient while generating the appropriate applicator deflection angle required to rotationally align or orient the applicator tip to the intended target tissue/anatomy for treatment. Methods are also described for deploying drug delivery devices within these body structures using the systems to treat medical conditions associated therewith.

1 . A system for accessing and dilating one or more target tissue sites associated with a paranasal sinus, an ear canal, or a Eustachian tube, comprising:
 an applicator, the applicator having a proximal end, a deflectable distal end, and a device lumen;   a handle coupled to the applicator proximal end, the handle having a fluid communication port;   an expandable member configured to move through the device lumen to a position at or adjacent to the deflectable distal end, and having an interior volume in fluid communication with the fluid connection port;   a fluid source, configured to reversibly provide fluid to, and draw out fluid from, the interior volume of the expandable member;   an adjustment knob concentrically coupled to the applicator proximal end; and   a pullwire having a proximal end and a distal end, extending alongside the device lumen, where the pullwire distal end is attached to the applicator distal end and the pullwire proximal end is coupled to the adjustment knob.   
     
     
         2 . A system for accessing one or more target tissue sites associated with a paranasal sinus, an ear canal, or a Eustachian tube, comprising:
 an applicator, the applicator having a proximal end, a deflectable distal end, and a device lumen;   a handle coupled to the applicator proximal end;   an adjustment knob concentrically coupled to the applicator proximal end; and   a pullwire having a proximal end and a distal end, extending alongside the device lumen, where the pullwire distal end is attached to the applicator distal end and the pullwire proximal end is coupled to the adjustment knob.   
     
     
         3 . The system of  claim 2 , wherein the adjustment knob is configured to move in order to deflect the deflectable distal end to a preset deflection angle oriented to access the target tissue site. 
     
     
         4 . The system of  claim 3 , wherein the adjustment knob is configured to move in order to deflect the deflectable distal end to a preset deflection angle of about 70 degrees relative to a longitudinal axis of the applicator. 
     
     
         5 . The system of  claim 3 , wherein the adjustment knob is configured to move in order to deflect the deflectable distal end to a preset deflection angle of about 110 degrees relative to a longitudinal axis of the applicator. 
     
     
         6 . The system of  claim 3 , wherein the adjustment knob is configured to move in order to deflect the deflectable distal end to a preset deflection angle of about zero degrees relative to a longitudinal axis of the applicator. 
     
     
         7 . The system of  claim 3 , wherein the adjustment knob is configured to move in order to deflect the deflectable distal end to a preset deflection angle in the range of from about 45 to about 90 degrees relative to a longitudinal axis of the applicator. 
     
     
         8 . The system of  claim 2 , further comprising a guidewire having a proximal end and a distal end, the guidewire proximal end being coupled to and movable along the length of the handle, and the guidewire distal end being disposed within and movable along the length of the device lumen. 
     
     
         9 . The system of  claim 2 , wherein the handle includes a fluid connection port and wherein the system further comprises an expandable member configured to move through the device lumen to a position at or adjacent to the deflectable distal end, and having an interior volume in fluid communication with the fluid connection port. 
     
     
         10 . The system of  claim 9 , a fluid source coupled to the fluid connection port, wherein the fluid source is configured to reversibly provide fluid to, and draw out fluid from, the interior volume of the expandable member 
     
     
         11 . The system of  claim 9 , wherein the expandable member further comprises a drug coating, the drug coating including a therapeutic agent, wherein the therapeutic agent comprises a corticosteroid or pharmaceutically acceptable salts, solvates, hydrates, esters, free base, enantiomers, racemates, polymorphs, amorphous, or crystal forms thereof. 
     
     
         12 . A method for accessing one or more target tissue sites associated with a paranasal sinus, an ear canal, or a Eustachian tube, comprising:
 advancing a system to the target tissue site, wherein the system comprises:
 an applicator comprising a proximal end, a deflectable distal end, a device lumen, and an expandable device; 
 a handle coupled to the applicator proximal end; 
 a pullwire attached to the applicator distal end and extending alongside the device lumen; and 
 an adjustment knob connected to the pullwire and concentrically coupled to the applicator; 
   deflecting the distal end of the applicator to a deflection angle by linearly translating the pullwire;   accessing the target tissue site with the applicator at the deflection angle;   advancing the expandable device within the device lumen and over a guidewire; and   expanding the expandable device to contact the target tissue site of the paranasal sinus.   
     
     
         13 . The method of  claim 12 , wherein deflecting the distal end of the applicator orients the system for accessing a frontal sinus or frontal sinus ostium. 
     
     
         14 . The method of  claim 12 , wherein deflecting the distal end of the applicator orients the system for accessing a maxillary sinus or maxillary sinus ostium. 
     
     
         15 . The method of  claim 12 , wherein deflecting the distal end of the applicator orients the system for accessing a sphenoid sinus or sphenoid sinus ostium. 
     
     
         16 . The method of  claim 12 , wherein deflecting the distal end of the applicator orients the system for accessing the Eustachian tube. 
     
     
         17 . The method of  claim 12 , wherein deflecting the distal end of the applicator orients the system for accessing the ear canal. 
     
     
         18 . The method of  claim 12 , wherein contact of the expandable device to the target tissue site delivers a therapeutic agent to the target tissue site. 
     
     
         19 . The method of  claim 12 , wherein the expandable device comprises an expandable balloon having a drug coating. 
     
     
         20 . The method of  claim 19 , wherein the drug coating comprises a corticosteroid or pharmaceutically acceptable salts, solvates, hydrates, esters, free base, enantiomers, racemates, polymorphs, amorphous, or crystal forms thereof.