Emboli protection devices and related methods of use

Abstract

An embolic protection system and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The embolic protection system includes a guide catheter, a multi-lumen tube having a sealing surface on the distal end and an interventional device. A method of treating a blood vessel includes providing a guide catheter and a multi-lumen elongate member having proximal and distal ends, evacuation and inflation lumens extending therebetween and a sealing surface on the distal end. The elongate member is advanced through the guide catheter into a blood vessel that supplies blood to the heart proximal a lesion. The sealing surface is expanded to engage the endoluminal surface of the blood vessel and stop antegrade flow. An interventional device is advanced through the evacuation lumen to treat the lesion.

1 . An embolic protection system for treating a lesion in a blood vessel, comprising:
 a guide catheter having a guide lumen;   an evacuation sheath, comprising:
 an evacuation tube having an evacuation lumen, a first sealing surface, and a second sealing surface; 
 a first actuator connected to the evacuation tube; 
 wherein the first actuator seals the first sealing surface against an internal surface of the guide lumen and seals the second sealing surface against an internal surface of the blood vessel; 
   an interventional device movable through the evacuation lumen to treat the lesion distal of the evacuation sheath.   
     
     
         2 . The embolic protection system of  claim 1 , wherein the evacuation sheath further comprises a second actuator connected to the evacuation tube at a location proximal of the first actuator. 
     
     
         3 . The embolic protection system of  claim 2 , wherein the first actuator is an actuation wire and the second actuator is a hollow shaft. 
     
     
         4 . The embolic protection system of  claim 3 , wherein the actuation wire extends through the hollow shaft. 
     
     
         5 . The embolic protection system of  claim 1 , wherein the evacuation sheath further comprises a steerable tip. 
     
     
         6 . The embolic protection system of  claim 1 , wherein the evacuation sheath further comprises a nose cone extending distally from the evacuation tube. 
     
     
         7 . The embolic protection system of  claim 1 , further comprising a delivery sheath movable from a first position covering the evacuation tube when positioning the evacuation tube relative to the guide catheter, and a second position removed from covering the evacuation tube. 
     
     
         8 . The embolic protection system of  claim 2 , wherein operating the first and second actuators comprises retracting the first actuator while maintaining an axial position of the second actuator. 
     
     
         9 . The embolic protection system of  claim 1 , wherein the evacuation tube comprises a braided sheath. 
     
     
         10 . The embolic protection system of  claim 9 , wherein the evacuation tube comprises a coating or covering positioned on the braided sheath. 
     
     
         11 . The embolic protection system of  claim 10 , wherein the coating comprises an elastomeric material. 
     
     
         12 . The embolic protection system of  claim 10 , wherein the covering comprises at least one layer of spun fibers. 
     
     
         13 . The embolic protection system of  claim 1 , wherein the evacuation tube is self-expanding. 
     
     
         14 . The embolic protection system of  claim 1 , wherein operating the first actuator expands the evacuation tube. 
     
     
         15 . An embolic protection system, comprising:
 a guide catheter having a guide lumen;   an evacuation sheath, comprising:
 an evacuation tube having an evacuation lumen, a first sealing surface, and a second sealing surface; 
 a first actuator connected to the evacuation tube; 
 a second actuator connected to the evacuation tube at a location proximal of a connection point of the first actuator to the evacuation tube; 
 wherein the first and second actuators seal the first sealing surface against an internal surface of the guide lumen and seals the second sealing surface against an internal surface of the blood vessel, 
   
     
     
         16 . The embolic protection system of  claim 15 , wherein the first actuator is an actuation wire and the second actuator is a hollow shaft. 
     
     
         17 . The embolic protection system of  claim 16 , wherein the actuation wire extends through the hollow shaft. 
     
     
         18 . The embolic protection system of  claim 15 , wherein operating the first and second actuators includes retracting the first actuator while maintaining an axial position of the second actuator to expand the evacuation tube. 
     
     
         19 . A method of treating a lesion within a blood vessel, comprising:
 advancing a guide catheter having proximal and distal ends and a guide lumen therebetween to a region of interest within a blood vessel;   advancing an evacuation sheath through the guide lumen to the region of interest within the blood vessel, the evacuation sheath comprising an evacuation tube having an evacuation lumen, a first sealing surface, and a second sealing surface, and at least a first actuator connected to the evacuation tube;   operating the first actuator to seal the first sealing surface against an internal surface of the guide lumen and seal the second sealing surface against an internal surface of the blood vessel;   advancing an interventional instrument through the evacuation lumen into the blood vessel such that the interventional instrument is positioned across the lesion;   treating the lesion with the interventional instrument; and   applying suction to the evacuation lumen to induce retrograde flow within the blood vessel.   
     
     
         20 . The method of  claim 19 , wherein the evacuation sheath further comprises a second actuator connected to the evacuation tube at a location proximal of connection point of the first actuator to the evacuation tube, wherein operating the first actuator includes retracting the first actuator and operating the second actuator includes maintaining an axial position of the second actuator thereby expanding the evacuation tube.