Temporary occlusion balloon devices and methods for preventing blood flow through a vascular perforation

Abstract

A device for occluding a perforation in a blood vessel includes a catheter shaft that has a first lumen and a second lumen. The first lumen is adapted to receive at least one of a guidewire and an implanted cardiac lead, and the second lumen is adapted to receive an inflation fluid. The device further includes an inflatable balloon that is carried by the catheter shaft. The inflatable balloon is adapted to receive the inflation fluid from the second lumen, wherein the second lumen includes a cross-sectional area at a location within the catheter shaft between 0.65 mm2 and 1.90 mm2 and the inflatable balloon comprises polyurethane having a Shore A durometer of about 85 A.

What is claimed is: 
     
         1 . A device comprising:
 a catheter shaft configured to be positioned within vasculature of a patient, wherein the catheter shaft comprises a first lumen; and   a balloon comprising:
 a proximal portion coupled to the catheter shaft; 
 a distal portion coupled to the catheter shaft; and 
 a middle portion disposed between the proximal portion and the distal portion, 
   wherein the balloon is configured to be inflated to occlude a perforation in the vasculature during removal of an implanted cardiac lead from a patient,   wherein, when the balloon is inflated, the middle portion comprises:
 a first diameter that is constant along a first length of the balloon; and 
 a second diameter that is constant along a second length of the balloon, 
   wherein the first diameter and the second diameter are different from one another, and   wherein the first lumen comprises a diameter sized to receive the implanted cardiac lead such that:
 the catheter shaft is advanceable along the implanted cardiac lead to a position within the vasculature where the balloon is proximate to the perforation; and 
 the implanted cardiac lead extends within the first lumen proximate to the balloon. 
   
     
     
         2 . The device according to  claim 1 , wherein the balloon comprises a working length of about 65 mm to about 80 mm. 
     
     
         3 . The device according to  claim 1 , wherein the catheter shaft further comprises a second lumen, wherein the balloon is configured to receive an inflation fluid from the second lumen. 
     
     
         4 . The device according to  claim 3 , wherein the balloon comprises an inflated diameter of about 20 mm to about 25 mm. 
     
     
         5 . The device according to  claim 3 , wherein the second lumen has a width of about 1.8 mm. 
     
     
         6 . The device according to  claim 3 , wherein the second lumen has a height of about 0.75 mm. 
     
     
         7 . The device according to  claim 6 , wherein the second lumen has a width of about 1.8 mm. 
     
     
         8 . The device according to  claim 3 ,
 wherein the catheter shaft comprises an outer diameter,   wherein the outer diameter is about 2 mm,   wherein the second lumen includes a cross-sectional area at a location along a length of the catheter shaft between 0.65 mm 2  and 1.90 mm 2 , and   wherein the cross-sectional area of the second lumen comprises a crescent shape.   
     
     
         9 . The device according to  claim 8 , wherein the second lumen has a width of about 1.8 mm. 
     
     
         10 . The device according to  claim 8 , wherein the second lumen has a height of about 0.75 mm. 
     
     
         11 . The device according to  claim 10 , wherein the second lumen has a width of about 1.8 mm. 
     
     
         12 . The device according to  claim 8 , wherein the cross-sectional area of the second lumen is about 1 mm 2 . 
     
     
         13 . The device according to  claim 8 ,
 wherein the crescent shape provides the cross-sectional area with a crescent-like cross-sectional shape, and   wherein the crescent-like cross-sectional shape has a radius of about between 0.50 mm to 1.50 mm.   
     
     
         14 . The device according to  claim 13 , wherein the radius of the crescent-like cross-sectional shape is about 1 mm. 
     
     
         15 . The device according to  claim 8 , wherein the first lumen and the second lumen are non-concentrically disposed within the catheter shaft. 
     
     
         16 . The device according to  claim 15 ,
 wherein the crescent shape provides the cross-sectional area with a crescent-like cross-sectional shape, and   wherein the crescent-like cross-sectional shape has a radius of about between 0.50 mm to 1.50 mm.   
     
     
         17 . The device according to  claim 16 , wherein the radius of the crescent-like cross-sectional shape is about 1 mm. 
     
     
         18 . The device according to  claim 15 ,
 wherein the catheter shaft comprises a first wall portion between the first lumen and the outer diameter,   wherein the first wall portion is about 0.15 mm.   
     
     
         19 . The device according to  claim 18 ,
 wherein the catheter shaft comprises a second wall portion between the second lumen and the outer diameter,   wherein the second wall portion is about 0.15 mm.   
     
     
         20 . The device according to  claim 15 ,
 wherein the catheter shaft comprises a wall portion between the second lumen and the outer diameter,   wherein the wall portion is about 0.15 mm.