Device and Method for Dilating an Airway Stenosis

Abstract

A medical device and a system and for dilating a stenotic airway of a patient are described. The medical device comprises a proximal end, a distal end, and a shaft system having an inflation lumen and a ventilation lumen the proximal end. The shaft system has a proximal shaft section and a distal shaft section. An inflatable balloon is attached to the distal shaft section in a position that is proximal to the distal end. The ventilating tip is distal to the balloon on the distal shaft section and has one or more radially facing openings. A method for treating a stenotic airway includes inserting the medical device into a patient's airway, and dilating and ventilating the airway.

1 - 12 . (canceled) 
     
     
         13 . A connector for connecting a medical device to a ventilation source and an inflation source; said connector comprises a ventilation port and an inflation port, wherein the ventilation port and the inflation port are selected from the groups consisting of ports of different sizes, ports of different shapes and ports of different connection types;
 wherein the inflation source is selected from the group consisting of water, saline and contrast agent; and   wherein the ventilation source is selected from the group consisting of oxygen and air.   
     
     
         14 . The connector of  claim 13  wherein when the inflation port comprises a threaded connector, the ventilation port comprises a non-threaded connector and when the inflation port comprises a non-threaded connector, the ventilation port comprises a threaded connector. 
     
     
         15 . The connector of  claim 13  wherein the ventilation port is larger in diameter than the inflation port. 
     
     
         16 . The connector of  claim 13  wherein when the inflation port comprises a right-handed threaded connector, the ventilation port comprises a left-handed threaded connector and when the ventilation port comprises a right-handed threaded connector, the inflation port comprises a left-handed threaded connector. 
     
     
         17 . A packaged kit for treating an airway stenosis, the kit comprising:
 a medical device comprising an inflation lumen, a ventilating lumen, an inflatable balloon and a ventilating tip, the inflation lumen and the ventilating lumen being adjacent lumens and the ventilating tip comprising at least one radially facing opening;   an optional balloon insertion stylet for insertion of the medical device into the anatomy; and   ventilating tubing for connecting the medical device to a ventilation source.   
     
     
         18 . A packaged kit for treating an airway stenosis, the kit comprising:
 a medical device comprising an inflation lumen, a ventilating lumen, an inflatable balloon and a ventilating tip, the inflation lumen and the ventilating lumen being adjacent lumens and the ventilating tip comprising at least one radially facing opening; and   a balloon insertion stylet for insertion of the medical device into the anatomy.   
     
     
         19 . A method for treating a stenotic region in the airway of a human patient, said method comprising:
 providing a medical device comprising an inflation lumen, a ventilating lumen, an inflatable balloon and a ventilating tip, the inflation lumen and the ventilating lumen being adjacent lumens and the ventilating tip comprising a tip opening and at least one radially facing opening;   inserting the medical device into the airway;   positioning the medical device at the stenotic region in the airway;   inflating the balloon to dilate the airway;   deflating the balloon;   optionally repeating the inflating and deflating steps;   withdrawing the medical device from the airway;   wherein oxygen is delivered through the ventilating lumen before, during or after the inflating step.   
     
     
         20 . A method for treating a stenotic region in the airway of a human patient, said method comprising:
 providing a medical device comprising an inflation lumen, a ventilating lumen, an inflatable balloon and a ventilating tip, the inflation lumen and the ventilating lumen being adjacent lumens and the ventilating tip comprising a tip opening and at least one radially facing opening;   inserting the medical device into the airway;   positioning the medical device at the stenotic region in the airway;   inflating the balloon to dilate the airway;   deflating the balloon;   optionally repeating the inflating and deflating steps;   withdrawing the medical device from the airway;   wherein air is inspired through the ventilating lumen before, during or after the inflating step.   
     
     
         21 . The method of  claim 20  wherein the stenotic region is in the airway portion selected from the group consisting of larynx, trachea and bronchi. 
     
     
         22 . The method of  claim 19  wherein the stenotic region is in the airway portion selected from the group consisting of larynx, trachea and bronchi.