Guide wire passage creation device

Claim 1

A guide wire passage creation device for use in a blood vessel impassably occluded by atheromatic material, the device being adapted to enable a subsequent revascularization process requiring traversal of the occlusion by a guide wire, the device comprising: a catheter having proximal and distal ends, the distal end culminating in a tip; means for creating a passage through the atheromatic material for subsequent guide wire traversal, the guide wire passage creation means being adapted to create a passage whose diameter is no larger than necessary to permit subsequent traversal by a guide wire; the catheter having at least three lumens, comprising: a first lumen having a diameter no greater than about 0.02 inches, for insertion of a guide wire and for injection of a contrast dye, a second lumen including the guide wire passage creation means, and a third lumen communicating with an annular balloon disposed circumferentially at the distal end of the catheter adjacent the tip, the annular balloon having proximal and distal ends, and further comprising a plurality of smaller balloons disposed around the distal end of the annular balloon and spaced at approximately equal angular positions around the circumference of the annular balloon, the smaller balloons being selectively inflatable and deflatable to make intimate contact with the wall of the blood vessel to refine the position of the guide wire passage creation means in the vessel the annular balloon performing the following functions: centering the distal end of the device when the distal tip of the device is positioned immediately proximal to the atheromatic material in the occluded blood vessel, stabilizing the distal end of the device when the distal tip of the device is positioned immediately proximal to the atheromatic material in the occluded blood vessel, and preventing blood flow in the event of a rupture in the blood vessel wall; and operator controlled means at the proximal end of the device for deploying the multipurpose means and for deploying the guide wire passage creation means; wherein the distal end of the catheter is substantially rigid from the tip to a distance beginning no less than about 10 millimeters and no more than about 20 millimeters from the tip, and wherein the multipurpose means is coaxial with the rigid portion of the catheter, so that the rigid portion and multipurpose means cooperatively act to center and stabilize the guide wire passage creation means in the blood vessel.