Catheter having a funnel-shaped occlusion balloon of uniform thickness and methods of manufacture

Abstract

Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having a funnel-shaped occlusion balloon of uniform thickness disposed on a distal end of the catheter. The occlusion balloon is fused to the distal end so that it provides a substantially seamless flow transition into a working lumen of the catheter. Additionally, a distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate blood flow into the catheter and efficiently remove emboli.

1 . Apparatus for removing emboli from a vessel during an interventional procedure, the apparatus comprising: 
 a catheter having proximal and distal ends, a working lumen extending therethrough; and    an occlusion balloon having a distal end affixed to an interior surface of the working lumen and a proximal end everted to surround, and affixed to, a portion of the catheter proximal of the distal end of the catheter disposed on the distal end of the catheter, the occlusion balloon having a contracted state suitable for insertion into a vessel and a deployed state configured to occlude antegrade flow in the vessel,    wherein the occlusion balloon comprises a wall having a substantially uniform thickness along its length, and in the deployed state, provides a funnel-shaped transition into the working lumen.    
   
   
       2 . The apparatus of  claim 1  wherein the working lumen has an interior polymer cover.  
   
   
       3 . The apparatus of  claim 2  wherein the distal end of the occlusion balloon is fused to the interior polymer cover.  
   
   
       4 . The apparatus of  claim 3  wherein the distal end of the occlusion balloon is adhesively bonded to the interior polymer cover.  
   
   
       5 . The apparatus of  claim 3  wherein the occlusion balloon further comprises a distal section situated just proximal of the distal end, wherein the distal section of the occlusion balloon is fused to a distalmost end of the interior polymer cover.  
   
   
       6 . The apparatus of  claim 5  wherein an exterior surface of the catheter comprises an exterior polymer cover.  
   
   
       7 . The apparatus of  claim 5  wherein the proximal end of the occlusion balloon is fused to the exterior polymer cover.  
   
   
       8 . The apparatus of  claim 7  wherein the proximal end of the occlusion balloon is affixed to the exterior polymer cover at a distance between about 10-20 mm proximal of the distal end of the catheter.  
   
   
       9 . The apparatus of  claim 7  wherein the proximal end of the occlusion balloon is adhesively bonded to the exterior polymer cover.  
   
   
       10 . The apparatus of  claim 2  further comprising an inflation lumen disposed within the exterior polymer cover that is in fluid communication with the occlusion balloon.  
   
   
       11 . The apparatus of  claim 2  further comprising a radiopaque marker band disposed at the distal end of the catheter.  
   
   
       12 . The apparatus of  claim 11  wherein the catheter comprises a wire braid disposed between the interior polymer cover and the exterior polymer cover, the apparatus further comprising a radiopaque marker band disposed between the wire braid and exterior polymer cover.  
   
   
       13 . The apparatus of  claim 1  wherein the occlusion balloon further comprises a proximal taper in the deployed state.  
   
   
       14 . The apparatus of  claim 1  further comprising a blood outlet port coupled to the proximal end of the catheter.  
   
   
       15 . A method of manufacturing an emboli catheter for use in an interventional procedure, the method comprising: 
 providing a catheter having an exterior surface, proximal and distal ends and a working lumen extending therethrough having an interior surface;    providing an occlusion balloon having first and second ends and a uniform thickness therebetween;    affixing a first end of the occlusion balloon to the interior surface of the working lumen;    everting the second end of the occlusion balloon over the distal end of the catheter so that the second end is disposed surrounding the catheter at a position proximal of the distal end; and    affixing the second end of the occlusion balloon to the exterior surface of the catheter at the location proximal of the distal end.    
   
   
       16 . The method of  claim 15  wherein the interior surface of the working lumen comprises an interior polymer cover, and affixing the first end of the occlusion balloon to the interior surface of the working lumen comprises fusing the first end to the interior polymer cover.  
   
   
       17 . The method of  claim 15  wherein the interior surface of the working lumen comprises an interior polymer cover, and affixing the first end of the occlusion balloon to the interior surface of the working lumen comprises adhesively bonding the first end to the interior polymer cover.  
   
   
       18 . The method of  claim 15  wherein the exterior surface of the catheter comprises an exterior polymer cover, and affixing the second end of the occlusion balloon to the exterior surface of the catheter comprises fusing the second end to the exterior polymer cover.  
   
   
       19 . The method of  claim 15  wherein the exterior surface of the catheter comprises an exterior polymer cover, and affixing the second end of the occlusion balloon to the exterior surface of the catheter comprises adhesively bonding the second end to the exterior polymer cover.  
   
   
       20 . The method of  claim 15  wherein providing a catheter further comprises providing a catheter having a radiopaque marker band disposed on the catheter adjacent to the distal end.