Increased axial load carrying sheathed irrigating balloon catheter

Abstract

A sheathed tubular semi-rigid balloon catheter for performing probing, irrigation, dilation, suction and potential intubation of the nasolacrimal system or paranasal sinus system to treat for stenosis or obstruction. The catheter includes a sheathed tubular probe portion through which a tracer fluid can be injected and through which suctioning of blood or other material can be conducted. The sheath portion of the device can have a distal segment that is inflated in order to dilate parts the nasolacrimal or paranasal sinus system. The high axial load accommodating catheter tool includes a more secure and inexpensively manufactured bond between the metallic semi-rigid tube of the probe portion and the plastic hand-manipulable, multi-connector hub using an enlarged bonding collar.

What is claimed is: 
     
         1 . A balloon catheter which comprises:
 an oblong probe which comprises:
 an elongated substantially cylindrical hollow body having a first outer diameter and terminating at a distal extremity and an opposite proximal extremity; 
 said body being made from a hard, semirigid first material; 
 a collar bonded to a portion of said body near said proximal extremity; 
 said collar being made from a hard, semirigid second material; 
 said collar having an outer peripheral surface having a second diameter greater than said first outer diameter; 
   a hand graspable hub comprising a third rigid material, said hub being secured to said collar;   a flexible sheath coaxially engaged by said body;   wherein said sheath comprises:
 a proximal end portion secured to said hub; and, 
 a distal end portion comprising a balloon structure; 
   wherein said body has an axial lumen extending from a proximal opening to a distal port; and,   wherein said hub comprises:
 a first connector leading to a first passageway in fluid communication with said distal port; and, 
 a second connector leading to a second passageway in fluid communication with said balloon structure. 
   
     
     
         2 . The device of  claim 1 , wherein said catheter further comprises a hub/collar interfacing bond comprising an interface layer contacting said collar and said hub, and wherein said interfacing bond further comprises a proximal bead axially bearing against said collar. 
     
     
         3 . The device of  claim 2 , wherein said hub/collar interfacing bond is capable of withstanding an axial sheer load in excess of 10 Newtons. 
     
     
         4 . The device of  claim 1 , wherein said outer peripheral surface comprises a surface area increasing structure, and wherein said surface area increasing structure comprises a bearing surface having an axial component. 
     
     
         5 . The device of  claim 1 , wherein said outer peripheral surface of said collar is shaped to have a plurality of radial irregularities. 
     
     
         6 . The device of  claim 1 , wherein said second diameter is at least twice as large as said first diameter. 
     
     
         7 . The device of  claim 1 , wherein said sheath has an axial length shorter than an axial length of said body. 
     
     
         8 . The device of  claim 1 , wherein said sheath is shaped and dimensioned to allow for a gap between an outer surface of said body and an inner surface of said sheath. 
     
     
         9 . The device of  claim 1 , wherein said body further comprises:
 said distal extremity being blunted; and,   said body having a total length between approximately 4 and 50 centimeters and an outer diameter between 0.125 and 5.0 millimeters.   
     
     
         10 . The device of  claim 1 , wherein said first material is taken from a group consisting of:
 stainless steel, bronze, silver, aluminum, titanium, brass, and alloys thereof.   
     
     
         11 . The device of  claim 1 , wherein said first material and said second material are the same. 
     
     
         12 . The device of  claim 1 , wherein said probe has a maximum cross-sectional dimension of between about 1.0 millimeter and 4.0 millimeters. 
     
     
         13 . The device of  claim 1 , which further comprises:
 an elongated reinforcing rod shaped and dimensioned to be inserted into said lumen, and   wherein said reinforcing rod is further shaped to have a semicircular cross-section, thereby forming an axial groove extending an entire length of said rod; said groove being sized to accommodate passage of a fiberoptic cable therethrough.   
     
     
         14 . A method for probing the integrity of a small, tight opening through human tissue into the nasal cavity of a patient, said method comprises:
 inserting a balloon catheterization device into the patient's body;   wherein said balloon catheterization device comprises:
 a metal collared, elongated semi-rigid tubular body having a lumen; 
 a flexible sheath covering a portion of said body; and, 
 a hub secured to a proximal end of said body; 
   tilting the device angularly into alignment with said opening; and,   pushing the device through the opening;   wherein said pushing comprises applying an axial force in excess of 10 Newtons to said hub.   
     
     
         15 . The method of  claim 14 , which further comprises engaging a stiffening rod diametrically sized to engage said lumen and having a length greater than said total length into said lumen prior to said step of inserting. 
     
     
         16 . The method of  claim 14 , which further comprises engaging a stiffening rod diametrically sized to engage said lumen and having a length shorter than said total length into said lumen prior to said step of inserting. 
     
     
         17 . The method of  claim 14 , wherein:
 said inserting comprises inserting said balloon catheterization device through the patient's punctum and canaliculus down the lacrimal sac;   said tilting comprises tilting the balloon catheterization device angularly into alignment with the nasolacrimal duct; and,   said pushing comprises pushing the balloon catheterization device through the nasolacrimal duct down to the nasal cavity.   
     
     
         18 . The method of  claim 17 , which further comprises injecting an irrigation or tracer fluid through said balloon catheterization device while said device is engaged in said patient's lacrimal system. 
     
     
         19 . The method of  claim 17 , which further comprises suctioning material through said balloon catheterization device while said device is engaged in said patient's lacrimal system. 
     
     
         20 . In a semirigid balloon catheter tool including an oblong semirigid hollow tube having an axial lumen extending between a proximal opening and a distal port; an improvement which comprises:
 a reinforcing rod shaped to penetrate said lumen;   said rod having a semicircular cross-section, thereby forming an axial groove extending an entire length of said rod;   said groove being sized to accommodate passage of a fiberoptic cable therethrough.