Balloon encapsulation and isovolumetric suction thrombectomy catheter and methods thereof

Abstract

The disclosure provides for an adjustable catheter system with isovolumetric suction and restoration of fluid for the removal of a thrombus and a method of use thereof. The catheter system includes an inner catheter and an outer sheath surrounding at least a portion of the inner catheter. The inner catheter may include at least three lumina extending from the proximal end to the distal end of the inner catheter, at least one infusion fenestration along the infusion segment, and a distal encapsulation balloon at the distal end. The outer sheath may include at least three lumina extending from the proximal end to the distal end of the outer sheath and a proximal encapsulation balloon at the distal end. The catheter system may further include an agitator for mechanical morcellation of the thrombus.

What is claimed is: 
     
         1 . A catheter system for removal of a thrombus from a vessel, comprising:
 an inner catheter having a proximal end, an infusion segment, and a distal end, the inner catheter comprising:
 at least one infusion fenestration along the infusion segment; and 
 a distal encapsulation balloon at the distal end; and 
   an outer sheath having a proximal end and a distal end, the outer sheath comprising:
 a proximal encapsulation balloon at the distal end, 
   wherein the outer sheath surrounds at least a portion of the inner catheter and the distal encapsulation balloon and the proximal encapsulation balloon are separated by a distance along the infusion segment.   
     
     
         2 . The catheter system of  claim 1 , wherein the distal encapsulation balloon and the proximal encapsulation balloon are compliant balloons operable to accommodate varying vessel sizes and minimize damage or injury to the vessel. 
     
     
         3 . The catheter system of  claim 1 , wherein the distance between the distal encapsulation balloon and the proximal encapsulation balloon is adjustable. 
     
     
         4 . The catheter system of  claim 1 , wherein the distance between the distal encapsulation balloon and the proximal encapsulation balloon form a thrombolytic treatment area, wherein the thrombus to be removed is contained within the thrombolytic treatment area. 
     
     
         5 . The catheter system of  claim 4 , wherein the infusion segment is within the thrombolytic treatment area. 
     
     
         6 . The catheter system of  claim 5 , wherein the inner catheter is operable to infuse a fluid to the thrombolytic treatment area and the outer sheath is operable to provide suction to remove fluid from the thrombolytic treatment area. 
     
     
         7 . The catheter system of  claim 6 , wherein the inner catheter and outer sheath are operable to provide isovolumetric suction and restoration of fluid within the thrombolytic treatment area. 
     
     
         8 . The catheter system of  claim 1 , wherein the inner catheter further comprises at least three lumina extending from the proximal end to the distal end of the inner catheter. 
     
     
         9 . The catheter system of  claim 8 , wherein the inner catheter comprises an inflation lumen, a guide wire lumen, and an infusion lumen, and wherein at least one infusion fenestration along the infusion segment is connected to the infusion lumen to enable infusion of fluid. 
     
     
         10 . The catheter system of  claim 9 , wherein the inner catheter further comprises a manifold at its proximal end comprising an infusion port, a balloon inflation port, and a guidewire access port, wherein each port is fluidly connected to one of the at least three lumina of the inner catheter. 
     
     
         11 . The catheter system of  claim 1 , wherein the outer sheath further comprises at least three lumina extending from the proximal end to the distal end of the outer sheath. 
     
     
         12 . The catheter system of  claim 11 , wherein the outer sheath comprises an inflation lumen, a suction lumen, and a catheter lumen, and wherein the inner catheter is positioned within the catheter lumen of the outer sheath. 
     
     
         13 . The catheter system of  claim 12 , wherein the outer sheath further comprises a manifold at its proximal end comprising a suction port, a balloon inflation port, and a device access port, wherein each port is fluidly connected to one of the at least there lumina of the outer sheath. 
     
     
         14 . The catheter system of  claim 12 , wherein the catheter lumen is concentric with the suction lumen. 
     
     
         15 . The catheter system of  claim 1 , further comprising an agitator operable to agitate the thrombus. 
     
     
         16 . The catheter system of  claim 15 , wherein the outer heath encloses the agitator. 
     
     
         17 . The catheter system of  claim 15 , wherein the agitator is rail mounted on the outer sheath, configured to protrude from the distal end of the outer sheath, and/or the agitator is operable to advance and retract over a catheter lumen of the outer sheath. 
     
     
         18 . The catheter system of  claim 15 , wherein the agitator is operable to be used without touching a wall of the vessel. 
     
     
         19 . The catheter system of  claim 15 , wherein the agitator comprises a plurality of protrusions or brushes at a pitch angle operable to reduce shear stress on the vessel. 
     
     
         20 . The catheter system of  claim 19 , wherein the plurality of protrusions are distributed helically along the length of the agitator.