Apparatus and methods for reducing embolization during treatment of carotid artery disease

Abstract

Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having an occlusion element, an aspiration lumen, and a blood outlet port in communication with the lumen, a guide wire having a balloon, a venous return sheath with a blood inlet port, and tubing that couples the blood outlet port to the blood inlet port. Apparatus is also provided for occluding the external carotid artery to prevent reversal of flow into the internal carotid artery. The pressure differential between the artery and the vein provides reverse flow through the artery, thereby flushing emboli. A blood filter may optionally be included in-line with the tubing to filter emboli from blood reperfused into the patient.

1 . A method of delivering an interventional instrument for treating a stenosis in an internal carotid artery comprising:
 a) inserting an occlusion mechanism having a distal occlusion member and a balloon into a person's vasculature;   b) positioning the distal occlusion member to a desired position in the common carotid artery and the balloon to a desired position in the external carotid artery; and   c) operating the distal occlusion member and the balloon to occlude the external carotid artery and the central carotid artery.   
     
     
         2 . A method according to  claim 1 , wherein said occlusion mechanism further comprises a catheter having a proximal end and a distal end, an aspiration lumen extending therethrough, and said distal occlusion member positioned at said distal end of said catheter. 
     
     
         3 . A method according to  claim 2 , further comprising: aspirating blood through said aspiration lumen. 
     
     
         4 . A method according to  claim 2 , further comprising: inducing reverse flow to cause blood and emboli to flow into the aspiration lumen of the catheter. 
     
     
         5 . A method according to  claim 4  wherein inducing reverse flow further comprises:
 a) providing a venous return sheath having a proximal end and a distal end, a lumen extending therethrough, and a blood inlet port coupled to the lumen; and 
 b) causing blood flow between the aspiration lumen of the catheter and the blood inlet port of the venous return sheath to induce reverse flow.