Methods, devices, and systems for postconditioning with clot removal

Abstract

New devices, systems, and methods are disclosed for preventing, treating, and/or at least minimizing ischemia and/or reperfusion injury by restoring and/or modulating blood flow, particularly in the cerebral vasculature where blood vessels are narrow and tortuous. These devices, systems, and methods make it possible for a clinician to adequately and systematically restore blood flow to ischemic tissue while simultaneously modulating the blood flow to minimize reperfusion injury.

1 . An assembly configured to treat ischemia in a patient, comprising:
 a catheter with a proximal region, a distal region, and a single lumen;   a flow modulation member attached to the catheter and comprising an inflatable balloon configured to reversibly decrease and increase the flow of fluid through the blood vessel at least twice, and thereby modulate blood flow through the blood vessel, the flow modulation member comprises an inflatable balloon configured to receive a balloon inflation aperture continuous with the lumen;   a pushwire with a proximal end and a distal end, wherein the pushwire is at least partially within the single lumen;   a flow restoration member for increasing the flow of blood through the region of the clot, coupled to the distal end of the pushwire; and   one or more sealing members attached to one of the pushwire and catheter adapted to decrease the flow rate of inflating fluid leaving the single lumen and inflate the balloon.   
     
     
         2 . The assembly of  claim 1 , wherein the one or more sealing members comprise a protrusion with an outwardly facing surface attached to the pushwire at a location on the pushwire proximal to the flow restoration member. 
     
     
         3 . The assembly of  claim 2 , wherein the protrusion further slows the flow of fluid through the lumen when the protrusion engages an inwardly facing surface toward the pushwire at the distal region of the catheter. 
     
     
         4 . The assembly of  claim 1 , wherein the catheter lumen comprises a first section in the proximal region and a second section in the distal region, the first section of the lumen having a first area in a plane normal to the catheter's central axis that is larger than a second area in the plane normal to the catheter's central axis in the second section of the lumen. 
     
     
         5 . The assembly of  claim 1 , wherein one of the one or more sealing members is electrically controlled, whereby an electric current applied to the pushwire causes the sealing member to expand so as to provide more resistance to the flow of fluid through the catheter, whereby the flow modulation member is capable of expanding to produce a desired seal in the blood vessel. 
     
     
         6 . The assembly of  claim 1 , wherein the assembly is adapted to operate with a pressure of the fluid less than 5 atm. 
     
     
         7 . The assembly of  claim 1 , wherein a pump configured to perform postconditioning cycles is connected to the lumen leading to the inflatable balloon to deliver inflating fluid. 
     
     
         8 . The assembly of  claim 6 , wherein the pump is configured to provide at least two cycles of inflation and deflation and wherein at least one of the cycles following the first cycle occurs without additional operator intervention. 
     
     
         9 . The assembly of  claim 1 , wherein the flow restoration member for increasing the flow of blood through a blood vessel beyond a clot comprises a self-expanding scaffold, adapted to engage a clot in a blood vessel. 
     
     
         10 . The assembly of  claim 1 , wherein the one or more sealing members comprise a sealing tip at the distal end of the catheter, wherein a luminal edge of the sealing tip comes in close proximity with a sealing surface of the pushwire and slows the flow of fluid through the lumen when the sealing surface of the pushwire is placed through the sealing tip. 
     
     
         11 . The assembly of  claim 9 , wherein the sealing tip allows the flow restoration member to pass the sealing tip when the catheter is translated relative to the pushwire. 
     
     
         12 . An apparatus comprising:
 a catheter;   a balloon disposed on the catheter at a distal end of the catheter, the catheter defining a lumen and including an orifice for inflating the balloon;   a clot capturing reperfusion member located near a distal end of the wire, the wire being partially within the lumen of the catheter; and   a sealing interface between the wire and the lumen, nearer to the distal end of the catheter than is the orifice for inflating the balloon and adapted to seal the lumen so that the balloon may be inflated.   
     
     
         13 . The apparatus of  claim 12 , wherein the sealing interface includes an outwardly facing surface of the wire and surface of the lumen facing the pushwire. 
     
     
         14 . The apparatus of  claim 13 , wherein the inwardly facing sealing surface of the lumen has a smaller diameter than other portions of the lumen of the catheter. 
     
     
         15 . The apparatus of  claim 13 , wherein the outwardly facing surface of the wire has a larger diameter than other portions of the wire. 
     
     
         16 - 56 . (canceled) 
     
     
         57 . An assembly able to treat ischemia in the neurovasculature of a patient, comprising:
 a catheter with a proximal end, a distal end, and at least two catheter lumina;   one or more flow modulation members coupled to the catheter and comprising an inflatable balloon configured to reversibly decrease and increase a flow of fluid through a blood vessel at least twice, wherein the inflatable balloon has a balloon lumen continuous with a first catheter lumen and configured to receive inflating fluid from the first catheter lumen, wherein a distal end of the first catheter lumen is closed;   one or more pushwires each with a proximal end and a distal end, wherein a first pushwire of the one or more pushwires is placed at least partially within a second catheter lumen; and   one or more flow restoration members are coupled to the first pushwire near a distal end of the first pushwire.   
     
     
         58 . The assembly of  claim 57 , wherein a flow restoration member of the one or more flow restoration members comprises a self-expanding scaffold configured to engage a clot in a blood vessel. 
     
     
         59 . The method of  claim 57 , wherein a pump configured to perform postconditioning cycles is connected to the lumen leading to the inflatable balloon to deliver inflating fluid. 
     
     
         60 . The method of  claim 59 , wherein the pump is configured to provide at least two cycles of inflation and deflation and wherein at least one cycle after the first cycle occurs without additional operator intervention. 
     
     
         61 - 113 . (canceled)