Apparatus and methods for in situ embolic protection

Abstract

The present invention provides apparatus and methods for treating a vascular condition by restoring patency to a vessel while reducing the likelihood that emboli become dislodged into the bloodstream. In a first embodiment, the apparatus comprises a graft having proximal and distal regions, a first support member attached to the distal region of the graft, and a second support member attached to the proximal region of the graft. The first and second support members may comprise first and second stents, respectively. The first stent is deployed distal to a vascular condition, and the second stent is deployed proximal to a vascular condition, such that the graft spans the length of the vascular condition to entrap emboli during treatment of the vascular condition. In an alternative embodiment, the first stent is adapted to be deployed within a vessel at a location distal to the vascular condition, and the graft is adapted to be everted to form a pocket adapted to entrap emboli dislodged during treatment of the vascular condition. The second stent then may be subsequently deployed proximal to the vascular condition, such that emboli trapped within the graft pocket are effectively sealed off from the bloodstream.

1 . A method suitable for providing embolic protection during a vascular procedure, the method comprising:
 providing a graft having proximal and distal regions, a first support member attached to the distal region of the graft, and a second support member attached to the proximal region of the graft;   deploying the first support member to cause the first support member to engage an intima of the vessel at a location distal to a vascular condition;   treating the vascular condition; and   using the graft to entrap emboli dislodged during treatment of the vascular condition.   
   
   
       2 . The method of  claim 1  further comprising everting the graft by distally advancing the second support member with respect to the first support member, thereby forming a pocket distal to the vascular condition. 
   
   
       3 . The method of  claim 1  further comprising deploying the second support member at a location proximal to the vascular condition, thereby causing the graft to span the length of the vascular condition and enclose the vascular condition. 
   
   
       4 . The method of  claim 1  further comprising:
 providing an introducer having proximal and distal ends;   using the introducer to circumferentially enclose the first and second support members in a delivery state; and   proximally retracting the introducer with respect to the first and second support members to cause the first and second support members to self-expand into engagement with an intima of the vessel at locations distal to and proximal to the vascular condition, respectively.   
   
   
       5 . The method of  claim 4  further comprising treating the vascular condition by performing balloon angioplasty on the vascular condition using a balloon disposed on an exterior surface of the introducer. 
   
   
       6 . The method of  claim 1  further comprising placing a stent over the graft to secure the graft between the stent and the vascular condition. 
   
   
       7 . Apparatus suitable for providing embolic protection during a vascular procedure, the apparatus comprising:
 a graft having inner and outer surfaces, and further having proximal and distal regions;   a first support member attached to the distal region of the graft; and   a second support member attached to the proximal region of the graft,   wherein the first support member is adapted to be deployed within a vessel at a location distal to a vascular condition, and the graft is adapted to be everted to form a pocket adapted to entrap emboli dislodged during treatment of the vascular condition.   
   
   
       8 . The apparatus of  claim 7  wherein the first and second support members comprise first and second stents, respectively. 
   
   
       9 . The apparatus of  claim 7  wherein the second support member is adapted to be deployed within the vessel at a location proximal to the vascular condition to cause the graft to span and enclose the vascular condition. 
   
   
       10 . The apparatus of  claim 7  further comprising an introducer having proximal and distal ends, wherein the introducer is configured to circumferentially enclose the first support member, the second support member and the graft in a delivery state. 
   
   
       11 . The apparatus of  claim 10  wherein the introducer comprises an external surface and a balloon disposed thereon, the balloon adapted to perform angioplasty on the vascular condition. 
   
   
       12 . The apparatus of  claim 10  wherein the first and second support members comprise self-expanding support members that are adapted to be deployed when the introducer is retracted proximally beyond the respective first and second support members. 
   
   
       13 . The apparatus of  claim 10  further comprising a core member having proximal and distal regions, wherein the first support member, the second support member and the graft are disposed circumferentially around the core member in the delivery state, and wherein the core member comprises a lumen disposed between the proximal and distal regions of the core member, the lumen being configured to permit oxygenated fluid to flow upstream to arterial vasculature during treatment of the vascular condition. 
   
   
       14 . The apparatus of  claim 13  further comprising a first pushing member abutting the proximal end of the first support member and a second pushing member abutting the proximal end of the second support member. 
   
   
       15 . The apparatus of  claim 7  wherein at least a portion of the graft comprises a material having a known porosity to permit oxygenated fluid flow upstream, while substantially or completely prohibiting the flow of emboli. 
   
   
       16 . A method suitable for providing embolic protection during a vascular procedure, the method comprising:
 providing a graft having proximal and distal regions, a first support member attached to the distal region of the graft, and a second support member attached to the proximal region of the graft;   deploying the first support member to cause the first support member to engage an intima of the vessel at a location distal to a vascular condition;   everting the graft by distally advancing the second support member with respect to the first support member, thereby forming a pocket distal to the vascular condition;   treating the vascular condition; and   using the graft to entrap emboli dislodged during treatment of the vascular condition.   
   
   
       17 . The method of  claim 16  further comprising deploying the second support member at a location proximal to the vascular condition, thereby causing the graft to span the length of the vascular condition and enclose the vascular condition. 
   
   
       18 . The method of  claim 16  further comprising:
 providing an introducer having proximal and distal ends;   using the introducer to circumferentially enclose the first and second support members in a delivery state; and   proximally retracting the introducer with respect to the first and second support members to cause the first and second support members to self-expand into engagement with an intima of the vessel at locations distal to and proximal to the vascular condition, respectively.   
   
   
       19 . The method of  claim 18  further comprising treating the vascular condition by performing balloon angioplasty on the vascular condition using a balloon disposed on an exterior surface of the introducer. 
   
   
       20 . The method of  claim 16  further comprising placing a stent over the graft to secure the graft between the stent and the vascular condition.