Devices and Methods for Transnasal Dilation and Irrigation of the Sinuses

Abstract

A medical device, and a system and packaged kit containing the medical device for the treatment of a sinus opening is described. The medical device comprises a proximal end, a distal end, and a shaft system having an inflation lumen and an irrigation lumen the proximal and. 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 said distal end. The irrigation tip is distal to the balloon on the distal shaft section and has a tip opening and one or more radially facing openings. A method for treating a sinus opening includes inserting a system that includes the medical device, a sinus guide catheter and a sinus guide element into a patient's anatomy, dilating the sinus opening and irrigating a target in the nasal anatomy.

1 - 12 . (canceled) 
     
     
         13 . A system for accessing, dilating and irrigating a sinus, the system comprising:
 a sinus guide catheter;   a guiding element; and   a medical device comprising an inflation lumen, an irrigation lumen, an inflatable balloon and an irrigation tip;   wherein the inflation lumen and the irrigation lumen are adjacent lumens and the irrigation tip comprises at least one radially facing opening.   
     
     
         14 . The system of  claim 13  wherein the medical device further comprises one or more direct visualization markers. 
     
     
         15 . The system of  claim 13  wherein the medical device further comprises one or more radiographic markers. 
     
     
         16 . The system of  claim 13  wherein the at least radially facing opening comprises 3 openings. 
     
     
         17 . The system of  claim 16  wherein the radially facing openings have a diameter of between 0.020 inches and 0.050 inches. 
     
     
         18 . The system of  claim 17  wherein the radially facing openings have a diameter of 0.026 inches. 
     
     
         19 . The system of  claim 16  wherein the radially facing opening are spaced 120 degrees apart. 
     
     
         20 . The system of  claim 13  wherein the guiding element is selected from the group consisting of a guidewire or a sinus illumination system. 
     
     
         21 . The system of  claim 13 , the medical device further comprising a guide element lumen. 
     
     
         22 . The system of  claim 13 , wherein the medical device irrigation tip has an irrigation tip lumen proximal of the atraumatic tip, said irrigation tip lumen having an irrigation tip lumen diameter; and
 wherein the tip opening has a tip opening diameter; and   wherein the irrigation tip lumen diameter is greater than the tip opening diameter.   
     
     
         23 . The system of  claim 22  wherein the tip opening diameter is 0.037 inches and the irrigation tip lumen diameter is 0.042 inches. 
     
     
         24 . The system of  claim 13 , wherein the medical device proximal shaft section further comprises a stiffening member. 
     
     
         25 . The system of  claim 24  wherein the stiffening member comprises a hypotube. 
     
     
         26 . A packaged kit for treating a sinus opening, the kit comprising:
 a medical device comprising an inflation lumen, an irrigation lumen, an inflatable balloon and an irrigation tip, the inflation lumen and the irrigation lumen being adjacent lumens and the irrigation tip comprising at least one radially facing opening;   a balloon insertion stylet for insertion of the medical device into a sinus guide catheter;   and irrigation tubing for connecting the medical device to a source of irrigation fluid.   
     
     
         27 . A packaged kit for treating a sinus opening, the kit comprising:
 a medical device comprising an inflation lumen, an irrigation lumen, an inflatable balloon and an irrigation tip, the inflation lumen and the irrigation lumen being adjacent lumens and the irrigation tip comprising at least one radially facing opening;   a balloon insertion stylet for insertion of the medical device into a sinus guide catheter;   and a suction system for connecting the medical device to a vacuum source.   
     
     
         28 . A method for treating a target space in the nasal anatomy, said method comprising:
 providing a medical device comprising an inflation lumen, an irrigation lumen, an inflatable balloon and an irrigation tip, the inflation lumen and the irrigation lumen being adjacent lumens and the irrigation tip comprising a tip opening at least one radially facing opening;   inserting the medical device into a sinus guide catheter;   inserting guiding element into the medical device through the irrigation lumen;   positioning the guide catheter in the nasal anatomy;   advancing the guiding element into the target space of the nasal anatomy;   advancing the medical device over the guiding element into the target space of the nasal anatomy;   inflating the balloon to dilate a sinus opening;   deflating the balloon;   withdrawing the guiding element from the medical device;   connecting irrigation tubing to the medical device;   delivering fluid to the target space though the tip opening and the at least one radially facing opening.   
     
     
         29 . The method of  claim 28  wherein the delivering the fluid occurs at a flow rate of between 50 ml/min and 200 ml/min 
     
     
         30 . The method of  claim 29  wherein the flow rate is between 75 ml/min and 125 ml/min. 
     
     
         31 . The method of  claim 28  wherein the sinus opening is selected from the group consisting of a frontal sinus opening, a maxillary sinus opening, an ethmoid sinus opening and a sphenoid sinus opening. 
     
     
         32 . The method of  claim 28  wherein the fluid is selected from the group consisting of water, saline, contrast agents, antimicrobial agents anti-inflammatory agents, decongestants, mucous thinning agents, anesthetic agents, analgesic agents, anti-allergenic agents, allergens, anti-proliferative agents, hemostatic agents, cytotoxic agents, and biological agents or combinations of any of the above.