Methods and apparatus for treating disorders of the sinuses

Abstract

A medical device for the treatment of a sinus opening includes a handle, a grooming sheath, a rail, a guide wire, a balloon catheter and a balloon catheter movement mechanism. A method for treating a sinus opening includes inserting a medical device for the treatment of a sinus opening partially into a patient's anatomy, positioning a guide wire operatively extending from a rail of the medical device into a sinus opening of the patient, advancing a balloon catheter from an annular lumen of the medical device and along both the rail of the medical device and the guide wire with a balloon catheter movement mechanism, and inflating the balloon catheter.

What is claimed is: 
     
         1 . A medical device for the treatment of a sinus opening, the medical device comprising:
 a handle with:
 a proximal end; 
 a distal end; and 
 a longitudinal axis along the length of the handle; 
   a grooming sheath with a distal end and a proximal end, the proximal end of the grooming sheath attached to the distal end of the handle;   a first rail with a distal end and a proximal end and disposed partially within the grooming sheath such that an annular lumen is defined between the rail and the grooming sheath, the distal end of the rail having an first angled shape, the rail being rotatable relative to the longitudinal axis;   a guide wire operatively extending from the distal end of the rail;   a balloon catheter disposed at least partially in the handle and annular lumen; and   a balloon catheter movement mechanism operatively disposed on the handle;   wherein the balloon catheter movement mechanism is configured for advancement and retraction of the balloon catheter through the handle and annular lumen and along the rail and guide wire by user operation of the balloon catheter movement mechanism.   
     
     
         2 . The medical device of  claim 1  wherein the distal end of the grooming sheath is expandable to facilitate advancement and retraction of the balloon catheter. 
     
     
         3 . The medical device of  claim 2  wherein the distal end of the grooming sheath comprises expandable slits. 
     
     
         4 . The medical device of  claim 1  wherein the guide wire is attached to the distal end of the rail and extends beyond the distal end of the rail a predetermined fixed length. 
     
     
         5 . The medical device of  claim 1  further including:
 a guide wire movement mechanism operatively disposed on the handle; and 
 wherein the rail has a rail lumen, and 
 wherein the guide wire is disposed at least partially in the handle and the rail lumen; and 
 wherein the guide wire movement mechanism and the guide wire are configured for advancement and retraction of the guide wire through the handle and rail lumen by user operation of the guide wire movement mechanism. 
 
     
     
         6 . The medical device of  claim 5  further including a guide wire locking and rotation mechanism. 
     
     
         7 . The medical device of  claim 1  wherein the guide wire has:
 a proximal end; 
 a distal end; and 
 an atraumatic tip attached to the guide wire distal end; 
 
     
     
         8 . The medical device of  claim 1  wherein the grooming sheath is configured to collapse a deflated balloon catheter during retraction of the balloon catheter into the annular lumen. 
     
     
         9 . The medical device of  claim 1  wherein the balloon catheter has a working segment. 
     
     
         10 . The medical device of  claim 9  wherein the working segment further comprises a distal extension. 
     
     
         11 . The medical device of  claim 9  wherein the balloon catheter, rail and guide wire are configured such that the balloon catheter can be advanced from the annular lumen in a manner that the working segment is positioned entirely over the guide wire for inflation of the balloon catheter. 
     
     
         12 . The medical device of  claim 9  wherein the balloon catheter, rail and guide wire are configured such that the balloon catheter can be advanced from the annular opening in a manner that the working segment is positioned partially over the guide wire and partially over the rail for inflation of the balloon catheter. 
     
     
         13 . The medical device of  claim 9  wherein the balloon catheter, rail and guide wire are configured such that the balloon catheter can be advanced from the annular opening in a manner that that the working segment is at least partially extended beyond the end of the guide wire rail inflation of the balloon catheter. 
     
     
         14 . The medical device of  claim 1  wherein at least a portion of the rail is formed of a malleable material such that the shape of the rail can be manipulated by a user. 
     
     
         15 . The medical device of  claim 1  wherein the first rail may be removed and replaced with a second rail having a second angled shape. 
     
     
         16 . The medical device of  claim 1  wherein the rail includes an endoscopic visible marking. 
     
     
         17 . The medical device of  claim 1  wherein the distal end of the grooming sheath includes an atraumatic tip. 
     
     
         18 . A method for treating a sinus opening, the method comprising:
 inserting a medical device for the treatment of a sinus opening partially into a patient's anatomy;   positioning a guide wire operatively extending from a rail of a medical device into a sinus opening of the patient;   advancing a balloon catheter of the medical device from an annular lumen of the medical device and along both the rail of the medical device and the guide wire; and   treating the sinus opening via inflation of the balloon catheter,   wherein the annular lumen is between the rail and a grooming sheath of the medical device, and   wherein the advancing is accomplished via user operation of a balloon catheter movement mechanism of the medical device.   
     
     
         19 . The method of  claim 18  further comprising:
 deflating the balloon catheter; 
 retracting the balloon catheter into the grooming sheath; and 
 removing the medical device from the patient's anatomy. 
 
     
     
         20 . The method of  claim 18  wherein the positioning includes advancing the guide wire from a rail lumen of the rail via a sliding movement of a guide wire movement mechanism of the medical device along a handle of the medical device. 
     
     
         21 . The method of  claim 20  further comprising:
 deflating the balloon catheter; 
 retracting the balloon catheter into the grooming sheath and retracting the guide wire into the rail lumen; and 
 removing the medical device from the patient's anatomy. 
 
     
     
         22 . The method of  claim 18  wherein the patient's anatomy is a nostril. 
     
     
         23 . The method of  claim 18  wherein the rail is formed of a malleable material and the method further comprises:
 configuring the malleable rail into a shape appropriate for the sinus opening to be treated prior to the inserting step. 
 
     
     
         24 . The method of  claim 18  wherein the treating step includes inflating a working segment of the balloon catheter that is disposed entirely over the guide wire. 
     
     
         25 . The method of  claim 18  wherein the treating step includes inflating a working segment of the balloon catheter that is disposed partially over the guide wire and partially over the rail. 
     
     
         26 . The method of  claim 18  wherein the treating step includes inflating a working portion of the balloon catheter that extends beyond a distal end of the guide wire. 
     
     
         27 . The method of  claim 18  further comprising suctioning the sinus opening. 
     
     
         28 . The method of  claim 18  further comprising irrigating the sinus opening.