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. The handle has a proximal end, a distal end and a longitudinal axis along the length of the handle. The grooming sheath has a distal end and a proximal end with the proximal end of the grooming sheath being attached to the distal end of the handle. The rail has a distal end and a proximal end and disposed partially within the grooming sheath to define an annular lumen is between the rail and the grooming sheath. The guide wire operatively extends from the distal end of the rail and the balloon catheter is disposed at least partially in the handle and annular lumen. The balloon catheter movement mechanism operatively disposed on the handle and configured for advancement and retraction of the balloon catheter through both the handle and the annular lumen and along both the rail and guide wire by user operation of the 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 and then positioning a guide wire operatively extending from a rail of a medical device into a sinus opening of the patient. The method further includes 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. The method also includes treating the sinus opening via inflation of the balloon catheter. In the method, the annular lumen is between the rail and a grooming sheath of the medical device and the advancing is accomplished via user operation of a balloon catheter movement mechanism of the medical device.

1 .- 28 . (canceled) 
     
     
         29 . An apparatus, comprising:
 (a) a handle assembly comprising a body extending from a proximal portion to a distal portion;   (b) a shaft extending from the distal portion of the body, the shaft defining a lumen;   (c) a guidewire slidably disposed within the lumen of the shaft, the guidewire defining a longitudinal axis, the guidewire comprising a distal tip that is configured to actuate distally past the shaft;   (e) an actuating body slidably coupled to the body of the handle; and   (f) a locking assembly coupled to the actuating body, the locking assembly being configured to transition between a locked configuration and an unlocked configuration, a portion of the guidewire extending through the locking assembly,
 the guidewire being configured to translate relative to the locking assembly while the locking assembly is in the unlocked configuration, 
 the actuating body, while the locking assembly is in the locked configuration, being configured to both drive the guidewire within the lumen and rotate the guidewire about the longitudinal axis. 
   
     
     
         30 . The apparatus of  claim 29 , the locking assembly comprising a collet configured to compress against the guidewire in the locked configuration to thereby affix the collet to the guidewire. 
     
     
         31 . The apparatus of  claim 30 , the locking assembly comprising a barrel slidably attached to the collet. 
     
     
         32 . The apparatus of  claim 31 , the collet being rotatably attached to the actuating body. 
     
     
         33 . The apparatus of  claim 32 , the barrel defining an opening, the collet extending through the opening. 
     
     
         34 . The apparatus of  claim 33 , wherein a surface of the barrel being configured to compress the collet in the locked configuration. 
     
     
         35 . The apparatus of  claim 34 , the barrel being configured to rotate both the collet and the guidewire in the locked configuration. 
     
     
         36 . The apparatus of  claim 31 , the barrel comprising a raised ring feature disposed on an outer surface of the barrel. 
     
     
         37 . The apparatus of  claim 29 , the apparatus comprising a rail extending distally from the shaft. 
     
     
         38 . The apparatus of  claim 37 , further comprising a balloon catheter slidably disposed on the rail. 
     
     
         39 . The apparatus of  claim 38 , the rail and the shaft defining an annular space housing a portion of the balloon catheter. 
     
     
         40 . The apparatus of  claim 29 , the shaft being rotatable relative to the handle assembly. 
     
     
         41 . The apparatus of  claim 40 , the shaft being configured to selectively lock into a plurality of rotational positions relative to the handle assembly. 
     
     
         42 . The apparatus of  claim 29 , further comprising a second actuating body. 
     
     
         43 . The apparatus of  claim 42 , the second actuating body being slidably coupled to the handle assembly. 
     
     
         44 . The apparatus of  claim 43 , the second actuating body being fixed to a balloon catheter. 
     
     
         45 . The apparatus of  claim 29 , the actuating body comprising a nose piece, the nose piece being configured to receive the guidewire and direct the guidewire into the handle assembly. 
     
     
         46 . The apparatus of  claim 29 , the actuating body comprising a hypo-tube. 
     
     
         47 . An apparatus, comprising:
 (a) a handle assembly comprising a body extending from a proximal portion to a distal portion;   (b) a shaft extending from the distal portion of the body, the shaft defining a lumen;   (c) a balloon catheter slidably disposed within the lumen of the shaft, the balloon catheter being configured to actuate distally past the shaft;   (d) a guidewire slidably disposed within the lumen of the shaft, the guidewire being configured to actuate distally past the shaft and the balloon catheter;   (e) a first actuating body slidably coupled to the body of the handle assembly and attached to the balloon catheter, the first actuating body being configured to actuate the balloon catheter relative to the lumen of the shaft;   (e) a second actuating body slidably coupled to the body of the handle assembly and configured to selectively attach to the guidewire, the second actuating body being configured to actuate the guidewire relative to the lumen of the shaft.   
     
     
         48 . An apparatus, comprising:
 (a) a handle assembly comprising a body extending from a proximal portion to a distal portion;   (b) a shaft extending from the distal portion of the body, the shaft defining a lumen;   (c) a balloon catheter slidably disposed within the lumen of the shaft, the balloon catheter being configured to actuate distally past the shaft;   (d) a guidewire slidably disposed within the lumen of the shaft and extending along a long axis, the guidewire being configured to actuate distally past the shaft and the balloon catheter;   (e) a first actuating body slidably coupled to the body of the handle assembly and attached to the balloon catheter, the first actuating body being configured to actuate the balloon catheter relative to the lumen of the shaft;   (e) a second actuating body slidably coupled to the body of the handle assembly and configured to selectively attach to the guidewire, the second actuating body being configured to transition between a locked configuration and an unlocked configuration,
 the second actuating body being configured to both actuate the guidewire relative to the lumen of the shaft and rotate the guidewire the long axis in the locked configuration, 
 the second actuating body being configured to slidably receive the guidewire in the unlocked configuration.