Devices and Methods For Minimally Invasive Access to Sinuses And Treatment of Sinusitis

Abstract

The present invention provides minimally invasive devices and methods for accessing the sinuses and their surrounding structures for surgery and other treatments. The anterior ethmoid and maxillary sinuses are accessed and treated under minimal anesthesia with little or no postoperative limitation of activity or adverse symptoms. Direct visual verification of the sinuses and their natural ostia is utilized. Other paranasal sinuses may be treated by this method as well. The sinuses, in particular the maxillary and anterior ethmoid, are accessed via a direct anterior to posterior axis and the natural ostia of those sinuses is directly visualized for placement of a guide-free dilator, in the desired location within the natural ostia. That access to the maxillary ostium is accomplished by the anterior transuncinate “keyhole” approach in which a hole is punched in the uncinate process with the described devices according to the described methods. The properly placed dilator is expanded to allow drainage of the inflamed sinus and then withdrawn. An analogous ethmoid bulla “keyhole” approach and subsequent dilation are used for the anterior ethmoid sinus ostia. Pharmaceutical agents may be placed at desired locations in the sinuses using the same access technique.

1 .- 6 . (canceled) 
     
     
         7 . A device for dilating a sinus comprising: a first shaft connected to a second shaft, said second shaft comprising a semi rigid distal portion on which a dilator is located and that is angled in the range of 0 to about 145 degrees with respect to the proximal portion of said second shaft. 
     
     
         8 . The device of  claim 7 , wherein the first shaft is rigid. 
     
     
         9 . The device of  claim 7 , wherein the first shaft is substantially rigid. 
     
     
         10 . The device of  claim 7 , wherein the first shaft is malleable. 
     
     
         11 . The device of  claim 7 , wherein the second shaft is removably attached to the first shaft. 
     
     
         12 . The device of  claim 7 , wherein the semi rigid distal portion of the second shaft is angled in the range of about 30 degrees to about 60 degrees. 
     
     
         13 . The device of  claim 7 , wherein the semi rigid distal portion of the second shaft is angled at about 45 degrees. 
     
     
         14 . The device of  claim 7 , wherein the semi rigid distal portion of the second shaft comprises an external sheath of a plastic or fiber compound. 
     
     
         15 . The device of  claim 7 , wherein the semi rigid distal portion of the second shaft comprises a polymer of silicone rubber, polyurethane, polyethylene terephthalate, polyethylene, polypropylene, polyvinyl chloride, polymethyl methacrylate or polytetrafluoro ethylene. 
     
     
         16 . The device of  claim 7 , wherein the second shaft is malleable. 
     
     
         17 . The device of  claim 7 , wherein the semi rigid distal portion of the second shaft ends in a spatulate or ellipsoid tip. 
     
     
         18 . The device of  claim 7 , further comprising an inflation conduit emanating from an inflation port on said first shaft and terminating at the dilator. 
     
     
         19 . The device of  claim 7 , wherein the dilator comprises a balloon. 
     
     
         20 . The device of  claim 19 , wherein the balloon has an ellipsoid or figure-8 configuration. 
     
     
         21 . The device of  claim 19 , wherein the length of the balloon is between about 1.0 cm and about 2.0 cm and the diameter of the balloon is between about 4 mm and about 7 mm. 
     
     
         22 . A device for dilating a sinus comprising:
 a rigid handle connected to a first shaft;   a second shaft connected to the first shaft distal to the connection of said first shaft with said handle;   
       said second shaft comprising a semi rigid distal portion on which a dilator is located and that is angled in the range of 0 to about 145 degrees with respect to the proximal portion of said second shaft. 
     
     
         23 . The device of  claim 22 , wherein the first shaft is substantially rigid. 
     
     
         24 . The device of  claim 22 , wherein the second shaft is malleable. 
     
     
         25 . The device of  claim 22 , wherein the second shaft is removably attached to the first shaft. 
     
     
         26 . The device of  claim 22 , wherein the dilator comprises a balloon.