Balloon catheters and methods for treating paranasal sinuses

Abstract

A set of sinus balloon catheters are provided for treating a patient's paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities. These include a balloon catheter with a bend placing a distal segment at 90° to a proximal segment and a balloon catheter which is substantially straight. The catheters have sufficient stiffness and column strength that the balloon carrying distal segment of the catheter can be pushed into the prepared opening, natural ostium or duct, or sinus to be excised. The catheters have appropriate inflated working diameters and appropriate outer diameters with the balloon deflated that will enable the catheter to be pushed into the respective prepared opening, natural ostium or duct, or sinus cavity to be excised. The methods use the balloon catheters to dilate prepared openings to selected parts of the sinus system, to dilate natural ostia and ducts of the sinus system, and/or to dilate sinus cavities to remove them.

1 - 25 . (canceled) 
     
     
         26 . A method of using a first balloon catheter to treat a patient, wherein the first balloon catheter comprises:
 (i) a first tubular catheter body having a proximal segment and a distal segment,   (ii) a balloon mounted located at the distal segment of the first tubular catheter body, and   (iii) a port located at the proximal segment of the first tubular catheter body, wherein the port is configured to provide fluid under pressure to inflate the balloon;   wherein the method comprises:   (a) pushing the distal segment of the first tubular catheter body via the proximal segment of the first tubular catheter body to position the distal segment of the first tubular catheter body into a space associated with a nasal sinus of the patient, wherein the balloon is in a deflated state during the act of pushing, the first tubular catheter body having sufficient stiffness and column strength to be pushed into the space; and   (b) introducing fluid under pressure through the proximal segment of the first tubular catheter body to inflate the balloon and dilate the space.   
     
     
         27 . The method of  claim 26 , wherein the first tubular catheter body has a bend placing the distal segment at an angle of 70° to 115° to the proximal segment. 
     
     
         28 . The method of  claim 27 , wherein the angle is 90°. 
     
     
         29 . The method of  claim 26 , wherein the space is a maxillary ostium of the patient's maxillary sinus, wherein the act of introducing fluid under pressure through the proximal segment of the first tubular catheter body to inflate the balloon and dilate the space comprises dilating the maxillary ostium being to complete antrostomy of the maxillary ostium. 
     
     
         30 . The method of  claim 29 , further comprising:
 (a) retracting the patient's middle turbinate medially to gain access to the patient's middle meatus; and   (b) exposing the patient's ethmoid infundibulum by removing part of the patient's uncinate process;   wherein the acts of retracting the patient's middle turbinate and exposing the patient's ethmoid infundibulum are performed before the act of pushing the distal segment of the tubular catheter.   
     
     
         31 . The method of  claim 26 , further comprising preparing the space by forming an opening through the patient's fontanelle, wherein the act of forming comprises:
 (i) bringing a 45° upbiting Blakesely punch into the patient's nasal cavity along the patient's lateral nasal wall just superior to the patient's inferior turbinate, and   (ii) pushing the punch through the fontanelle to create the opening through the fontanelle;   wherein the act of pushing the distal segment of the first tubular catheter body comprises pushing the distal segment of the first tubular catheter body via the proximal segment of the first tubular catheter body to position the distal segment of the first tubular catheter body into the formed opening through the patient's fontanelle.   
     
     
         32 . The method of  claim 26 , wherein the space is a prepared opening formed through the patient's lateral nasal wall in the patient's inferior meatus. 
     
     
         33 . The method of  claim 32 , further comprising:
 (a) displacing the patient's inferior turbinate medially;   (b) introducing a sharp dissector into the patient's nasal cavity; and   (c) using the dissector to perforate the patient's lateral nasal wall in the inferior meatus to form the prepared opening through the patient's lateral nasal wall in the patient's inferior meatus;   wherein the acts of displacing the patient's inferior turbinate, introducing a sharp dissector, and using the dissector are performed before the act of pushing the distal segment of the tubular catheter.   
     
     
         34 . The method of  claim 26 , wherein the distal segment is positioned at an angle of 130° to 180° to the proximal segment. 
     
     
         35 . The method of  claim 26 , wherein the distal segment includes a slot, wherein the first tubular catheter body is closed at a point distal to the slot. 
     
     
         36 . The method of  claim 26 , wherein the space is formed in the patient's ethmoid bulla. 
     
     
         37 . The method of  claim 36 , further comprising:
 (a) retracting the patient's middle turbinate is medially to gain access to the patient's middle meatus;   (b) exposing the patient's ethmoid infundibulum by removing part of the patient's uncinate process; and   (c) using a fine cutting forceps to remove an anterior wall of the ethmoid bulla;   wherein the acts of retracting the patient's middle turbinate, exposing the patient's ethmoid infundibulum, and using a fine cutting forceps are performed before the act of pushing the distal segment of the tubular catheter.   
     
     
         38 . The method of  claim 37 , further comprising removing the ethmoid bulla. 
     
     
         39 . The method of  claim 38 , further comprising, after removing the ethmoid bulla:
 (a) pushing the distal segment of the first tubular catheter body into one of the patient's anterior ethmoid air cells lying posterior to the space formerly occupied by the ethmoid bulla,   (b) inflating the balloon to dilate the anterior ethmoid air cells and thereby remove the anterior ethmoid air cells;   (c) deflating the balloon; and   (d) removing the distal segment from the space formerly occupied by the anterior ethmoid air cell.   
     
     
         40 . The method of  claim 39 , further comprising:
 (a) perforating the patient's basal lamella of the patient's middle turbinate to form a second opening;   (b) pushing the distal segment of the first tubular catheter body into a posterior ethmoid air cell;   (c) inflating the balloon is inflated to dilate and remove the posterior ethmoid cell;   (d) deflating the balloon; and   (e) removing the distal segment from the space formerly occupied by the posterior ethmoid air cell.   
     
     
         41 . The method of  claim 40 , further comprising, after removing the distal segment from the space formerly occupied by the anterior ethmoid air cell and removing the distal segment from the space formerly occupied by the posterior ethmoid air cell:
 (a) inserting the distal segment of the first tubular catheter body through the patient's anterior wall of the patient's sphenoid sinus;   (b) inflating the balloon for dilation and removal of the sphenoid sinus;   (c) deflating the balloon; and   (d) removing the distal segment to complete sinusotomy of the sphenoid sinus.   
     
     
         42 . The method of  claim 39 , further comprising, after removing the distal segment from the space formerly occupied by the anterior ethmoid air cell:
 (a) providing a second balloon catheter, wherein the second balloon catheter comprises:
 (i) a second tubular catheter body having a proximal segment and a distal segment, 
 (ii) a balloon mounted located at the distal segment of the second tubular catheter body, and 
 (iii) a port located at the proximal segment of the second tubular catheter body, wherein the port is configured to provide fluid under pressure to inflate the balloon; 
   (b) pushing the distal segment of the second tubular catheter body via the proximal segment of the second tubular catheter body into a frontonasal duct, wherein the balloon of the second balloon catheter is in a deflated state during the act of pushing the distal segment of the second tubular catheter body;   (c) inflating the balloon of the second balloon catheter to dilate the frontonasal duct;   (d) deflating the balloon of the second balloon catheter; and   (e) removing the distal segment of the second tubular catheter body to complete a frontal sinusotomy.   
     
     
         43 . A kit for treating flow paths from sinus cavities, the kit comprising:
 (a) a first balloon catheter, wherein the first balloon catheter comprises:
 (i) a shaft, wherein the shaft of the first balloon catheter is angled, and 
 (ii) a balloon configured to transition between an inflated state and a deflated state, 
 wherein the first balloon catheter has an outer diameter sized to pass into a flow path of a sinus cavity when the balloon of the first balloon catheter is in the deflated state, 
 wherein the balloon of the first balloon catheter is configured to expand the flow path of the sinus cavity when the balloon of the first balloon catheter is in an expanded state; and 
   (b) a second balloon catheter, wherein the first balloon catheter comprises:
 (i) a shaft, wherein the shaft of the second balloon catheter is substantially straight, and 
 (ii) a balloon configured to transition between an inflated state and a deflated state, 
 wherein the second balloon catheter has an outer diameter sized to pass into a flow path of a sinus cavity when the balloon of the second balloon catheter is in the deflated state, 
 wherein the balloon of the second balloon catheter is configured to expand the flow path of the sinus cavity when the balloon of the second balloon catheter is in an expanded state. 
   
     
     
         44 . The kit of  claim 43 , wherein the first shaft has sufficient stiffness and column strength to enable the balloon of the first balloon catheter to be inserted transnasally through a nasal cavity and pushed, without being supported and guided by a guide wire, snugly into a passageway in a paranasal sinus cavity; and
 wherein the second shaft has sufficient stiffness and column strength to enable the balloon of the second balloon catheter to be inserted transnasally through a nasal cavity and pushed, without being supported and guided by a guide wire, snugly into a passageway in a paranasal sinus cavity.   
     
     
         45 . An apparatus comprising:
 (a) a tubular body, wherein the tubular body comprises:
 (i) a proximal end, 
 (ii) a proximal segment, 
 (iii) a distal end, and 
 (iv) a distal segment, 
 wherein the distal segment is positionable to a preset angle of less than 180° relative to the proximal segment; and 
   (b) an inflatable member proximate to the distal segment, wherein the inflatable member is configured and operable to dilate a passageway in a paranasal sinus cavity;   wherein the tubular body is dimensioned and has sufficient stiffness and column strength to enable the inflatable member to be inserted transnasally through a nasal cavity and pushed, without being supported and guided by a guide wire, snugly into a passageway in a paranasal sinus cavity.