Apparatus and methods for treating stroke and controlling cerebral flow characteristics

Abstract

Apparatus and methods for treatment of stroke are provided. In a preferred embodiment, the present invention disposes at least one catheter having a distal occlusive member in the common carotid artery of the hemisphere of the cerebral occlusion. Retrograde flow may be provided through the catheter to effectively control cerebral flow characteristics. Under such controlled flow conditions, a thrombectomy device may be used to treat the occlusion, and any emboli generated are directed into the catheter.

1 . Apparatus suitable for treating stroke, the apparatus comprising: 
 a catheter having proximal and distal ends, a lumen extending therebetween, and an occlusive element disposed on the distal end, the occlusive element having an opening that communicates with the lumen, the occlusive element having a contracted position suitable for transluminal insertion and an expanded position wherein the occlusive element occludes antegrade flow in a vessel, wherein flow through the lumen of the catheter is configured to influence flow in a cerebral vessel when the catheter is disposed in a carotid artery; and    a deployable wire having proximal and distal ends, and further having a contracted state and a deployed state, wherein the deployable wire is adapted to be inserted into a patient's vessel in the contracted state, and wherein the distal end self-deploys to a predetermined shape in the deployed state.    
   
   
       2 . The apparatus of  claim 1  wherein the occlusive element comprises an inflatable balloon.  
   
   
       3 . The apparatus of  claim 1  further comprising: 
 a shaft having proximal and distal ends; and    a balloon having proximal and distal ends, the balloon being disposed near the distal end of the shaft.    
   
   
       4 . The apparatus of  claim 3  wherein the balloon is adapted to be disposed in a communicating artery.  
   
   
       5 . The apparatus of  claim 3  wherein the distal end of the balloon is everted.  
   
   
       6 . The apparatus of  claim 5  wherein the proximal end of the balloon is everted.  
   
   
       7 . A method for manipulating cerebral blood flow characteristics, the method comprising: 
 providing apparatus comprising a catheter having proximal and distal ends, a lumen extending therebetween, and an occlusive element affixed to the distal end;    positioning the distal end of the catheter in a selected vessel in a contracted state;    deploying the occlusive element affixed to the catheter to occlude antegrade flow in the selected vessel; and    providing retrograde flow through the lumen of the catheter to influence flow in a cerebral vessel.    
   
   
       8 . The method of  claim 7  wherein deploying the occlusive element of the catheter occludes antegrade flow in at least a common carotid artery.  
   
   
       9 . The method of  claim 7  further comprising: 
 providing a shaft having proximal and distal ends and a balloon disposed near the distal end of the shaft; and    deploying the balloon in an external carotid artery.    
   
   
       10 . Apparatus suitable for treating a vascular occlusion, the apparatus comprising: 
 a deployable wire having proximal and distal ends, and further having a contracted state and a deployed state, wherein the deployable wire is adapted to be inserted into a patient's vessel in the contracted state, and wherein the distal end self-deploys to a predetermined shape in the deployed state; and    an outer sheath having proximal and distal ends, wherein the outer sheath is configured to constrain the deployable wire in the contracted state,    wherein an annulus between the deployable wire and an inner surface of the outer sheath defines a drug delivery lumen that is in fluid communication with the distal end of the outer sheath.    
   
   
       11 . The apparatus of  claim 10  wherein the deployable wire comprises a shape-memory material.  
   
   
       12 . The apparatus of  claim 10  wherein the deployable wire further comprises an atraumatic tip affixed to the distal end.  
   
   
       13 . The apparatus of  claim 12  wherein a space between the distal end of the outer sheath and the atraumatic tip defines a drug delivery port, wherein the drug deliver port is in fluid communication with the drug delivery lumen.  
   
   
       14 . The apparatus of  claim 10  wherein the outer sheath comprises at least one drug delivery port disposed in a lateral surface of the outer sheath, wherein the drug delivery port is in fluid communication with the drug delivery lumen.  
   
   
       15 . The apparatus of  claim 10  wherein a distal section of the deployable wire comprises a smaller diameter relative to a proximal section of the deployable wire.  
   
   
       16 . The apparatus of  claim 15  wherein the deployable wire further comprises a coil disposed about a portion of the distal section.  
   
   
       17 . The apparatus of  claim 10  wherein the drug delivery lumen is configured to permit the delivery of at least one lytic agent to the distal end of the outer sheath.  
   
   
       18 . The apparatus of  claim 10  wherein the distal end of the deployable wire comprises a knot shape in the deployed state.  
   
   
       19 . The apparatus of  claim 10  wherein the deployable wire is substantially flush with an inner wall of a treatment vessel in the deployed state.  
   
   
       20 . A method for treating a vascular occlusion, the method comprising: 
 providing a deployable wire having proximal and distal ends in a contracted state substantially within an outer sheath having proximal and distal ends; and    delivering at least one lytic agent to the occlusion via a drug delivery lumen, wherein the drug delivery lumen is defined by an annulus formed between the deployable wire and an inner surface of the outer sheath.    
   
   
       21 . The method of  claim 20  further comprising delivering the lytic agent to the occlusion via at least one drug delivery port disposed in a lateral surface of the outer sheath.  
   
   
       22 . The method of  claim 20  further comprising delivering the lytic agent to the occlusion via a space formed between the distal end of the outer sheath and the distal end of the deployable wire.  
   
   
       23 . The method of  claim 20  further comprising: 
 positioning the distal end of the outer sheath at a location distal to the occlusion;    proximally retracting the outer sheath to self-deploy the deployable wire at a location distal to the occlusion; and    proximally retracting the deployable wire to snare a remaining portion of the occlusion.