Methods and systems for treatment of acute ischemic stroke

Abstract

Methods and devices are disclosed that enable safe, rapid and relatively short and straight access to the cerebral arteries for the introduction of interventional devices to treat acute ischemic stroke. In addition, the disclosed methods and devices provide means to securely close the access site to the cerebral arteries to avoid the potentially devastating consequences of a transcervical hematoma.

1 . A method for accessing a cerebral artery to treat acute ischemic stroke, comprising:
 forming a transcervical puncture opening through a wall of a common carotid artery;   inserting through the puncture opening an arterial access sheath system configured to be inserted directly into the common carotid artery without previously inserting an introducer sheath through the opening, the arterial access sheath system comprising:
 an arterial access sheath having an internal lumen extending between a proximal end region and a distal end region of the arterial access sheath; 
 a dilator inserted through the internal lumen and extending distal from the distal end region of the arterial access sheath; and 
 a first occlusion element coupled to a distal region of the arterial access sheath; 
   providing access to the cerebral artery via the internal lumen of the arterial access sheath; and   expanding the occlusion element of the arterial access sheath to occlude an artery selected from the group consisting of the common carotid artery and an internal carotid artery.   
     
     
         2 . A method as in  claim 1 , wherein forming the transcervical puncture opening comprises making the puncture opening directly into the common carotid artery accessed through a transcervical surgical incision. 
     
     
         3 . A method as in  claim 1 , wherein forming the transcervical puncture opening comprises performing a percutaneous puncture into the common carotid artery. 
     
     
         4 . A method as in  claim 1 , wherein the dilator comprises an outer diameter that approaches an inner diameter of the distal end region of the arterial access sheath. 
     
     
         5 . A method as in  claim 1 , further comprising:
 reversing a direction of natural blood flow in the internal carotid artery or common carotid artery; and   shunting blood from the cerebral artery of the patient via the arterial access sheath.   
     
     
         6 . A method as in  claim 1 , wherein the occlusion element is an inflatable balloon. 
     
     
         7 . A method as in  claim 1 , further comprising:
 inserting therapeutic device through the internal lumen of the arterial access sheath and into the cerebral artery; and   treating a thrombotic blockage in the cerebral artery.   
     
     
         8 . A method as in  claim 7 , wherein the therapeutic device is a stent delivery catheter and treating the thrombotic blockage comprises deploying a stent using the stent delivery catheter. 
     
     
         9 . A method as in  claim 7 , wherein the therapeutic device includes a device adapted to remove a thrombotic blockage. 
     
     
         10 . A method as in  claim 9 , wherein the device adapted to remove a thrombotic blockage comprises at least one of a coil, a basket, a snare, or a grasper. 
     
     
         11 . A method as in  claim 7 , wherein the therapeutic device includes a device adapted to disrupt a thrombotic blockage. 
     
     
         12 . A method as in  claim 11 , wherein the device adapted to disrupt a thrombotic blockage comprises at least one of a mechanical, hydraulic, vortex, sonic, ultrasonic, or other energy source. 
     
     
         13 . A method as in  claim 7 , wherein the therapeutic device includes a device adapted to aspirate the thrombotic blockage or debris generated from the thrombotic blockage. 
     
     
         14 . A method as in  claim 7 , wherein the therapeutic device includes a device adapted to infuse thrombolytic agents into a thrombotic blockage. 
     
     
         15 . A method as in  claim 7 , wherein the therapeutic device is a device adapted to establish a lumen through the thrombotic blockage. 
     
     
         16 . A method as in  claim 15 , wherein the device adapted to establish a lumen through the thrombotic blockage comprises at least one of a balloon catheter, a temporary stent, or a permanent stent. 
     
     
         17 . A method as in  claim 1 , wherein the distal end region of the sheath is tapered and wherein a distal end region of the dilator is tapered. 
     
     
         18 . A system for treating acute ischemic stroke, comprising:
 an arterial access sheath comprising an internal lumen extending between a proximal end region and a distal end region, wherein the arterial access sheath is adapted to provide access to a cerebral artery through a puncture opening in a wall of a common carotid artery;   a dilator adapted to be inserted through the internal lumen and extending distal to the distal end region of the arterial access sheath; and   an occlusion element coupled to the arterial access sheath at a distal region of the arterial access sheath, wherein the occlusion element is adapted to expand and occlude an artery selected from the group consisting of the common carotid artery and an internal carotid artery.   
     
     
         19 . A system as in  claim 18 , wherein the arterial access sheath comprises a stepped or tapered configuration wherein the distal end region has a reduced diameter relative to the proximal end region of the arterial access sheath. 
     
     
         20 . A system as in  claim 18 , wherein the arterial access sheath has a hoop strength sufficient to resist buckling of the arterial access sheath as the arterial access sheath is introduced into the common carotid artery. 
     
     
         21 . A system as in  claim 18 , wherein the dilator comprises a tapered distal end and an outer diameter that approaches an inner diameter of the distal end region of the arterial access sheath. 
     
     
         22 . A system as in  claim 18 , further comprising a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site. 
     
     
         23 . A system as in  claim 22 , further comprising a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state, wherein the flow control assembly includes one or more components that interact with the blood flow through the shunt. 
     
     
         24 . A system as in  claim 18 , wherein a distal tip of the arterial access sheath is configured to puncture the common carotid artery such that the arterial access sheath does not require a separate introducer device in order to be introduced into the common carotid artery. 
     
     
         25 . A system as in  claim 18 , wherein the distal end region of the sheath is tapered.