Apparatus and method for treatment of sinusitis

Abstract

A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. A cannula is positioned in the passageway. A visualization tool such as an endoscope is passed through a lumen or channel in the cannula to aid in visualization of the anatomical site of interest. A balloon dilation catheter is then deployed through or along the cannula so as to place the balloon within or across the constricted anatomical space (e.g., ostium). The balloon is then expanded so as to expand at least a portion of the constricted anatomical space. Alternative embodiments include the use of an optional guide wire and incorporating a endoscope lumen through the balloon dilation catheter.

1 . A method of treating sinusitis in a patient comprising:
 forming an artificial access passageway into a sinus cavity of the patient;   positioning a cannula within the access passageway, the cannula having a first lumen adapted for passage of a balloon dilation catheter, and a secondary lumen adapted for passage of a visualization tool;   inserting the visualization tool into the secondary lumen and visualizing an anatomical region of interest;   inserting the balloon dilation catheter into the first lumen and advancing the same so as to place the dilation balloon in or across the anatomical region of interest; and   dilating the dilation balloon.   
   
   
       2 . The method of  claim 1 , wherein the access passageway is formed in the canine fossa region of the patient. 
   
   
       3 . The method of  claim 1 , wherein the sinus cavity is the maxillary sinus. 
   
   
       4 . The method of  claim 1 , wherein the sinus cavity is the frontal sinus. 
   
   
       5 . The method of  claim 1 , wherein the cannula includes one or more curved portions. 
   
   
       6 . (canceled) 
   
   
       7 . The method of  claim 1 , wherein the cannula contains a biased portion that has a pre-formed configuration. 
   
   
       8 . The method of  claim 1 , wherein the cannula includes a distal tip that is canted. 
   
   
       9 . (canceled) 
   
   
       10 . (canceled) 
   
   
       11 . (canceled) 
   
   
       12 . (canceled) 
   
   
       13 . (canceled) 
   
   
       14 . The method of  claim 1 , wherein the visualization tool comprises a flexible endoscope. 
   
   
       15 . The method of  claim 1 , wherein the balloon dilation catheter comprises a distal tip projecting distally with respect to the dilation balloon. 
   
   
       16 . The method of  claim 15 , wherein the distal tip is curved. 
   
   
       17 . (canceled) 
   
   
       18 . The method of  claim 15 , wherein during the advancement of the dilation balloon across the anatomical region of interest, the distal tip is positioned in the posterior direction. 
   
   
       19 . The method of  claim 1 , wherein the anatomical region of interest is an ostium. 
   
   
       20 . The method of  claim 1 , wherein the anatomical region of interest is an infundibulum. 
   
   
       21 . A system for treatment of sinusitis in a patient comprising:
 a piercing tool for creating an artificial access passageway to a sinus cavity of the patient;   a cannula having a first lumen adapted for passage of a balloon dilation catheter, and a secondary lumen adapted for passage of a visualization tool; and   a balloon dilation catheter having an expandable balloon on a distal region thereof, the balloon dilation catheter being dimensioned for passage through the first lumen of the cannula.   
   
   
       22 . The system of  claim 21 , wherein the piercing tool further comprises a sheath for maintaining an opening in the artificial access passageway, the sheath being disposed on a shaft of the piercing tool. 
   
   
       23 . The system of  claim 22 , wherein the sheath is disposed within a recess on the shaft of the piercing tool. 
   
   
       24 . The system of  claim 21 , wherein the visualization tool comprises a flexible endoscope. 
   
   
       25 . (canceled) 
   
   
       26 . The system of  claim 21 , wherein the cannula includes one or more curved portions. 
   
   
       27 . (canceled) 
   
   
       28 . (canceled) 
   
   
       29 . (canceled) 
   
   
       30 . (canceled) 
   
   
       31 . (canceled) 
   
   
       32 . (canceled) 
   
   
       33 . (canceled) 
   
   
       34 . (canceled) 
   
   
       35 . The system of  claim 21 , wherein the balloon dilation catheter comprises a distal tip projecting distally with respect to the dilation balloon. 
   
   
       36 . The system of  claim 21 , wherein the piercing tool comprises a drill. 
   
   
       37 . The system of  claim 35 , wherein the distal tip is curved. 
   
   
       38 . (canceled) 
   
   
       39 . (canceled) 
   
   
       40 . (canceled) 
   
   
       41 . (canceled) 
   
   
       42 . (canceled) 
   
   
       43 . (canceled) 
   
   
       44 . A system for treatment of sinusitis in a patient comprising:
 a sheath for maintaining a working lumen through an artificial access passageway to a sinus cavity of the patient;   a cannula having a first lumen adapted for passage of a balloon dilation catheter, and a secondary lumen adapted for passage of a visualization tool; and   a balloon dilation catheter having an expandable balloon on a distal region thereof, the balloon dilation catheter being dimensioned for passage through the first lumen of the cannula.   
   
   
       45 - 73 . (canceled) 
   
   
       74 . A method of treating sinusitis in a patient comprising:
 forming an artificial access passageway into a sinus cavity of the patient;   positioning a cannula within the access passageway, the cannula having a lumen adapted for receiving a visualization tool and a balloon dilation catheter;   advancing a balloon dilation catheter through the lumen of the cannula with the dilation balloon in a collapsed state;   advancing the visualization tool through a lumen in the balloon dilation catheter and visualizing an anatomical region of interest with the visualization tool;   advancing the balloon dilation catheter to place the dilation balloon in or across the anatomical region of interest; and   dilating the dilation balloon.   
   
   
       75 . A method of treating sinusitis in a patient comprising:
 forming an artificial access passageway into a sinus cavity of the patient; positioning a cannula within the access passageway, the cannula having a   first lumen adapted for passage of a balloon dilation catheter, the cannula further including a visualization tool incorporated therein;   visualizing an anatomical region of interest with the visualization tool;   inserting the balloon dilation catheter into the first lumen and advancing the same so as to place the dilation balloon in or across the anatomical region of interest; and   dilating the dilation balloon.   
   
   
       76 . A system for treatment of sinusitis in a patient comprising:
 a piercing tool for creating an artificial access passageway to a sinus cavity of the patient;   a cannula having a first lumen adapted for passage of a balloon dilation catheter   a visualization tool secured to the cannula; and   a balloon dilation catheter having an expandable balloon on a distal region thereof, the balloon dilation catheter being dimensioned for passage through the first lumen of the cannula.   
   
   
       77 . A balloon dilation catheter for dilating an anatomical structure associated with paranasal sinus drainage comprising:
 an elongate tubular shaft having a proximal end and a distal end and a lumen extending therethrough;   an inflatable dilation balloon having a proximal end and a distal end, the proximal and distal ends of the inflatable dilation balloon being secured to an outer surface of the shaft, the portion of the shaft contained within the dilation balloon including at least one or more ports in communication with the shaft lumen; and   a curved tip extending distally from the distal end of the dilation balloon.   
   
   
       78 . The balloon dilation catheter of  claim 77 , wherein the shaft is formed from a material having a torsional stiffness such that rotation of the proximal end of the shaft translates to rotation of the distal end of the shaft in substantially a 1:1 manner. 
   
   
       79 . The balloon dilation catheter of  claim 77 , wherein the distal tip includes a bulbous tip. 
   
   
       80 . The balloon dilation catheter of  claim 77 , wherein the dilation balloon includes a plurality of wings in a deflated state. 
   
   
       81 . The balloon dilation catheter of  claim 77 , wherein the dilation balloon at least partially extends over the curved distal tip. 
   
   
       82 . The balloon dilation catheter of  claim 77 , wherein the balloon dilation catheter comprises a shaft having a braided portion. 
   
   
       83 . The balloon dilation catheter of  claim 77 , wherein the balloon dilation catheter comprises a shaft formed from hypotube having a plurality of slots formed therein. 
   
   
       84 . A method of treating an ostium of a paranasal sinus comprising:
 placing a balloon dilation catheter in the paranasal sinus, the balloon dilation catheter comprising a shaft, an inflatable dilation balloon disposed on a distal region of the shaft, and a curved tip extending from a distal end of the dilation balloon;   advancing the balloon dilation catheter into the ostium;   rotating the shaft of the balloon dilation catheter so as to re-orient the curved tip;   further advancing the balloon dilation catheter in the re-oriented direction; and   inflating the inflation dilation balloon to dilate the ostium.   
   
   
       85 . The method of  claim 84 , wherein the curved tip includes a bulbous tip. 
   
   
       86 . The method of  claim 84 , wherein the curved tip is advanced into the ostium in the posterior direction and during the further advancement of the dilation balloon catheter, the curved tip is positioned in the medial direction. 
   
   
       87 . An access tool for creating an artificial access passageway to a sinus cavity of the patient comprising:
 an elongate tissue penetration member including a shaft and a distal tip, and a recess disposed in the shaft proximal of the distal tip; and   a tubular sheath removably secured to the shaft in the recess, the tubular sheath including a flange portion.   
   
   
       88 . The access tool according to  claim 87 , further comprising a stop removably secured around the tubular sheath, the stop including a flange portion for engaging with tissue surrounding the artificial access passageway. 
   
   
       89 . The access tool according to  claim 87 , wherein the tubular sheath includes a plurality of slots. 
   
   
       90 . A cannula for positioning one or more devices within a paranasal sinus comprising:
 an elongate tubular shaft having a proximal end and a distal end and a first lumen extending therethrough, the elongate tubular shaft further including a second lumen extending along side at least a portion of the first lumen, the distal end of the elongate tubular shaft including at least one curved portion having a curvature between about 5° and 30°.   
   
   
       91 . The cannula of  claim 90 , further comprising a flexible polymeric tip secured to the distal end of the elongate tubular shaft. 
   
   
       92 . The cannula of  claim 90 , wherein the distal end of the elongate tubular shaft has a canted distal edge. 
   
   
       93 . The cannula of  claim 90 , wherein the second lumen is formed from a flexible material such that in the absence of any device in the second lumen, the second lumen is in a collapsed state. 
   
   
       94 . The cannula of  claim 90 , wherein the secondary lumen is dimensioned to receive a visualization tool. 
   
   
       95 . The cannula of  claim 90 , wherein the elongate tubular shaft has a single curved portion. 
   
   
       96 . The method of  claim 75 , wherein the visualization tool is integrated in the cannula. 
   
   
       97 . The method of  claim 75 , wherein the cannula has a secondary lumen adapted for passage of the visualization tool. 
   
   
       98 . The method of  claim 1 , wherein the cannula is positioned within a sheath disposed within the access passageway. 
   
   
       99 . The method of  claim 16 , further comprising orienting the distal tip by rotating the balloon dilation catheter. 
   
   
       100 . The system of  claim 21 , further comprising a sheath for maintaining an opening in the artificial passageway. 
   
   
       101 . The system of  claim 21 , wherein the balloon dilation catheter is configured for rotation within the artificial access passageway. 
   
   
       102 . The system of  claim 44 , wherein the balloon dilation catheter comprises a curved distal tip projecting distally with respect to the dilation balloon. 
   
   
       103 . The system of  claim 44 , wherein the cannula comprises a curved distal end. 
   
   
       104 . The method of  claim 74 , wherein a distal end of the cannula comprises a curved portion. 
   
   
       105 . The method of  claim 74 , wherein the cannula is positioned within a sheath disposed within the access passageway. 
   
   
       106 . The method of  claim 74 , wherein the balloon dilation catheter comprises a curved distal tip projecting distally with respect to the dilation balloon. 
   
   
       107 . The method of  claim 75 , wherein a distal end of the cannula comprises a curved portion. 
   
   
       108 . The method of  claim 75 , wherein the cannula is positioned within a sheath disposed within the access passageway. 
   
   
       109 . The method of  claim 75 , wherein the balloon dilation catheter comprises a curved distal tip projecting distally with respect to the dilation balloon. 
   
   
       110 . The system of  claim 76 , wherein the access passageway is formed in the canine fossa region of the patient. 
   
   
       111 . The system of  claim 76 , wherein the sinus cavity is the maxillary sinus. 
   
   
       112 . The system of  claim 76 , wherein the sinus cavity is the frontal sinus. 
   
   
       113 . The system of  claim 76 , wherein the cannula includes one or more curved portions. 
   
   
       114 . The system of  claim 76 , wherein the cannula contains a biased portion that has a pre-formed configuration. 
   
   
       115 . The system of  claim 76 , wherein the cannula includes a distal tip that is canted. 
   
   
       116 . The system of  claim 76 , wherein the visualization tool comprises a flexible endoscope. 
   
   
       117 . The system of  claim 76 , wherein the balloon dilation catheter comprises a distal tip projecting distally with respect to the dilation balloon. 
   
   
       118 . The system of  claim 117 , wherein the distal tip is curved. 
   
   
       119 . The system of  claim 117 , wherein during the advancement of the dilation balloon across the anatomical region of interest, the distal tip is positioned in the posterior direction. 
   
   
       120 . The system of  claim 117 , wherein the anatomical region of interest is an ostium. 
   
   
       121 . The system of  claim 120 , wherein the anatomical region of interest is an infundibulum. 
   
   
       122 . The system of  claim 76 , further comprising a sheath for maintaining an opening in the artificial passageway. 
   
   
       123 . The cannula of  claim 90 , wherein the curved portion is located at a distal end of the elongate tubular shaft. 
   
   
       124 . A system for treatment of sinusitis in a patient comprising:
 a sheath for maintaining a working lumen through an artificial access passageway to a sinus cavity of the patient;   a cannula having a lumen adapted for passage of a balloon dilation catheter, the cannula further including a visualization tool incorporated therein; and   a balloon dilation catheter having an expandable balloon on a distal region thereof, the balloon dilation catheter being dimensioned for passage through the lumen of the cannula.   
   
   
       125 . The system of  claim 124 , wherein a distal end of the cannula comprises a curved portion. 
   
   
       126 . The system of  claim 124 , wherein the balloon dilation catheter comprises a curved distal tip projecting distally with respect to the dilation balloon.