Medical device for removing thromboembolic material from cerebral arteries and methods of use

Abstract

The invention provides a medical device having an elongate catheter, a balloon occluder mounted on a distal end of the catheter, and optionally a chopping mechanism associated with an aspiration port of the catheter. Continuous or intermittent suction can be applied to the aspiration port which is distal to the occluder to dislodge thromboembolic material in a carotid or cerebral artery. Oxygenated blood or other fluid, which may be hypothermic, can be perfused through at least one perfusion port proximal to the occluder to maintain and augment perfusion of the collateral vasculature proximal to the occlusive lesion. The flow rate of blood or fluid can be controlled by rotating two cylindrical members. Neuroprotective agents or t-A can also be infused distal to the occluder through the aspiration port or an infusing port. Methods of using the devices in treating patients with acute stroke or occlusive cerebrovascular disease are also disclosed.

What is claimed is:  
     
         1 . A method for treating a carotid or cerebral artery, comprising the steps of: 
 inserting a distal end of a catheter into the carotid or cerebral artery, the catheter having a proximal end, a distal end, an expandable occluder mounted on the distal end, an aspiration port distal the occluder, and an aspiration lumen communicating with the port;    expanding the occluder to occlude the carotid or cerebral artery;    applying a negative pressure to the aspiration port; and    removing an occlusion from the carotid or cerebral artery.    
     
     
         2 . The method of  claim 1 , further comprising the step of perfusing oxygenated medium into the artery through a perfusion port proximal the occluder.  
     
     
         3 . The method of  claim 1 , wherein the occlusion is a thromboembolic material, and wherein the thromboembolic material is engaged by the aspiration port.  
     
     
         4 . The method of  claim 1 , wherein the catheter further comprises at least one perfusion port proximal to the occluder and communicating with a perfusion lumen.  
     
     
         5 . The method of  claim 1 , wherein the carotid artery is the common carotid artery.  
     
     
         6 . The method of  claim 1 , wherein the carotid artery is selected from the group consisting of the internal carotid artery and carotid siphon.  
     
     
         7 . The method of  claim 1 , wherein the artery is the middle cerebral artery.  
     
     
         8 . The method of  claim 1 , wherein the artery is the anterior cerebral artery.  
     
     
         9 . The method of  claim 1 , wherein the occluder is a balloon which communicates with an inflation lumen.  
     
     
         10 . The method of  claim 1 , wherein the catheter further comprises a chopping mechanism for removing the occlusion from the carotid or cerebral artery.  
     
     
         11 . The method of  claim 4 , wherein the catheter further comprises a second balloon occluder proximal the perfusion port.  
     
     
         12 . The method of  claim 2 , wherein the oxygenated medium is hypothermic.  
     
     
         13 . The method of  claim 1 , further comprising the step of infusing pharmaceutical agent into the carotid artery through the aspiration port.  
     
     
         14 . The method of  claim 1 , further comprising the step of localizing the thromboembolic material with intravascular ultrasound.  
     
     
         15 . The method of  claim 1 , further comprising the step of localizing the thromboembolic material with carotid doppler.  
     
     
         16 . The method of  claim 1 , further comprising the step of localizing the atheroma and establishing the direction of flow with transcranial doppler.  
     
     
         17 . The method of  claim 2 , wherein the oxygenated medium is blood.