| 主权项 |
1. A balloon catheter assembly comprising:
an outer catheter having a proximal end and a distal end, the distal end having a wall thickness, the outer catheter comprising at least two layers including a reinforcing layer and a base layer; an inner catheter located coaxially within a lumen of the outer catheter, the inner catheter having an injection lumen extending therethrough, the inner and outer catheters forming an inflation lumen therebetween; an outer adapter having a proximal end and a distal end, the proximal end being sized to fit over an outside diameter of the distal end of the outer catheter and configured to be affixed thereto, the distal end of the outer adapter having a reduced outer diameter that is smaller than an outside diameter of the distal end of the outer catheter, the distal end of the outer adapter having an inside diameter that is larger than an outside diameter of the inner catheter, thereby forming a fluid channel therebetween that is in fluid communication with the inflation lumen, the outer adapter having a single layer and being formed of a material that is different from that of the outer catheter base layer, the outer adapter having a wall thickness that is no more than 15% of the wall thickness of the distal end of the outer catheter; a balloon having a proximal end with an inner surface affixed to the reduced outer diameter of the outer adapter, the balloon having a distal end with an inner surface affixed to the outside diameter of the inner catheter, the balloon having an interior space that is in fluid communication with the fluid channel; and a support sheath having a proximal end positioned over an outside diameter of the outer adapter and a distal end positioned over an outside diameter of the proximal end of the balloon, the support sheath being composed of a single layer, being formed of a material substantially the same as the material of the outer adapter, and having a wall thickness substantially the same as the wall thickness of the outer adapter, wherein the balloon resides entirely within a predetermined volume having an outer diameter substantially equal to or less than the outside diameter of the distal end of the outer catheter when the balloon is in a deflated configuration, wherein the balloon can be inflated by introducing a fluid through the inflation lumen and fluid channel into the interior space of the balloon, and wherein the balloon can then be deflated by removing the fluid from the interior space such that the balloon returns entirely within the predetermined volume. |
