Low profile occlusion balloon catheter

Abstract

A low profile occlusion catheter having a guiding atraumatic tip that prevents entry of the balloon into collateral vessels. The occlusion catheter system is particularly well suited for use in vascular occlusion and includes a pressure monitoring line to monitor the degree and state of occlusion.

1 . An occlusion catheter system for use in occlusion of a vessel, the occlusion catheter system comprising:
 a flexible wire defining a longitudinal axis;   an inflation catheter member having a proximal end, a distal end, an inflation lumen and a first port at the distal end, the proximal end of the inflation catheter member connected to a proximal end of the flexible wire, the proximal end of the flexible wire positioned at least partially in the inflation lumen thereby forming a space between an outer surface of the flexible wire and an inner surface of the inflation lumen;   an occlusion member having a proximal occlusion member end, a distal occlusion member end and defining an internal space, the occlusion member comprised of an expandable member configured to expand to occlude the vessel, the proximal occlusion member end coupled to the distal end of the inflation catheter member, the first port opening into the space;   a distal catheter member having a proximal end and a distal end, the distal catheter member coupled to a distal end of the flexible wire and extending along the longitudinal axis, the distal occlusion member end coupled to the proximal end of the distal catheter member; and   a guiding atraumatic tip at the distal end of the distal catheter member, the guiding atraumatic tip having a distal section with a flattened shape defining two generally planar opposed surfaces, the distal section extending to a curved section that curves away from the longitudinal axis then proximally toward the occlusion member and then in an arc toward the longitudinal axis.   
     
     
         2 . The occlusion catheter system of  claim 1 , wherein the atraumatic tip is formed as an extension of the distal catheter member. 
     
     
         3 . The occlusion catheter system of  claim 1 , wherein the distal catheter member includes a distal catheter lumen extending along the longitudinal axis, the distal catheter lumen coupled concentrically about the flexible wire. 
     
     
         4 . The occlusion catheter system of  claim 1 , wherein the atraumatic tip includes an unconnected end positioned near the longitudinal axis in a relaxed state, the atraumatic tip configured to assume a linear configuration co-axial with the longitudinal axis for delivery. 
     
     
         5 . The occlusion catheter system of  claim 1 , wherein the atraumatic tip includes a reinforcing member configured to offer additional reinforcement to the atraumatic tip. 
     
     
         6 . The occlusion catheter system of  claim 1 , wherein the flexible wire is constructed of a material selected from the group consisting of nitinol, stainless steel, solid wire reinforced with an outer winding, polymer, stainless steel braiding over polyurethane, stainless steel helical windings over silicone, nitinol reinforced polymer, biocompatible polymer, biocompatible metal and metal-reinforced polymer, silicone, nylon, polyurethane, polyethylene terephthalate, latex, thermoplastic elastomer, polyether block amide. 
     
     
         7 . The occlusion catheter system of  claim 1 , wherein the atraumatic tip is constructed of a polymer material. 
     
     
         8 . The occlusion catheter system of  claim 1 , wherein the flexible wire is comprised of a first catheter member with a first lumen therein. 
     
     
         9 . The occlusion catheter system of  claim 1 , wherein the space between the outer surface of the flexible wire and the inner surface of the inflation lumen is annular. 
     
     
         10 . The occlusion catheter system of  claim 1 , wherein the guiding atraumatic tip includes two radiused curved opposing surfaces. 
     
     
         11 . The occlusion catheter system of  claim 1 , wherein the atraumatic tip includes an angle of curve, the angle of curve being between two hundred seventy degrees and one thousand eighty degrees (270°-1080°). 
     
     
         12 . The occlusion catheter system of  claim 11 , wherein the angle of curve is between three hundred degrees and three hundred fifty degrees (300°-350°). 
     
     
         13 . The occlusion catheter system of  claim 1 , wherein the distal catheter member includes a second port passing through a side wall of the distal catheter member, the second port communicates with a distal catheter lumen of the distal catheter member and a first lumen of the flexible wire. 
     
     
         14 . The occlusion catheter system of  claim 1 , wherein the flexible wire is constructed of a solid wire 
     
     
         15 . An occlusion catheter system for use in occlusion of a vessel, the occlusion catheter system comprising:
 a flexible wire defining a longitudinal axis;   an inflation catheter member having a proximal end, a distal end, an inflation lumen and a first port at the distal end, a proximal end of the flexible wire positioned at least partially in the inflation lumen thereby forming an annular space between an outer surface of the flexible wire and an inner surface of the inflation catheter member;   a proximal hub coupled to flexible wire and the inflation catheter member, the proximal end of the inflation catheter member connected to a proximal end of the flexible wire,   an occlusion balloon having a proximal balloon end, a distal balloon end and defining an internal space, the occlusion balloon having a collapsed state wherein the occlusion balloon is positioned adjacent the flexible wire for introduction of the occlusion catheter system into the vessel and an inflated state to occlude the vessel, the proximal balloon end coupled to the distal end of the inflation catheter member, the first port opening into the space;   a distal catheter member coupled to a distal end of the flexible wire, the distal balloon end coupled to the proximal end of the distal catheter member; and   a guiding atraumatic tip at the distal end of the distal catheter member, the guiding atraumatic tip having a distal section with a flattened shape defining two generally planar opposed surfaces, the distal section extending to a curved section that curves away from the longitudinal axis then proximally toward the occlusion member and then in an arc toward the longitudinal axis, the guiding atraumatic tip having a terminal end positioned proximate and separated from the longitudinal axis by a gap.   
     
     
         16 . The occlusion system of  claim 15 , wherein the guiding atraumatic tip is constructed of at least one of PEBAX and PBAX doped with a radio opaque substance. 
     
     
         17 . The occlusion system of  claim 15 , wherein a radio opaque tip marker is located at the terminal end. 
     
     
         18 . The occlusion system of  claim 15 , wherein the distal catheter member includes a second port passing through a side wall of the distal catheter member, the distal catheter member also including a distal catheter member lumen in fluid communication with the second port, the flexible wire including a first lumen therein, the first lumen being in fluid communication with the distal catheter member lumen. 
     
     
         19 . The occlusion system of  claim 15 , wherein the distal section of the atraumatic tip includes two generally radiused curved opposing surfaces. 
     
     
         20 . The occlusion system of  claim 15 , wherein the guiding atraumatic tip includes a cylindrical member, the cylindrical member connected to a distal end of the distal catheter member, the guiding atraumatic tip including a tapered transition section between the cylindrical member and the distal section.