Embolic protection device and methods of use

Abstract

An evacuation sheath assembly and method of reducing or removing a blockage within a vessel without permitting embolization of particulate matter is provided. The evacuation sheath assembly includes a first elongate tubular member, having proximal and distal ends and a main lumen configured to be placed in fluid communication with a blood vessel. An expandable member is provided on a distal portion of the tubular member. The evacuation assembly further includes a second elongate tubular member having an inflation lumen configured to be placed in fluid communication with the expandable member and a fluid inflator. The fluid inflator is configured to be placed in fluid communication with the inflation lumen in order to provide a regulated pressure fluid source for inflating the expandable member.

We claim: 
     
         1 . A fluid inflator comprising:
 a shuttle mechanism for controlling fluid flow to an expandable member via an inflation lumen, the shuttle mechanism comprising:
 a shuttle chamber having a pressure chamber and a vacuum chamber; 
 a shuttle movable within the shuttle chamber between at least first and second positions; 
   wherein the shuttle is operable to alternately place the pressure chamber in flow communication with a vacuum source, a pressurized fluid source, and the inflation lumen.   
     
     
         2 . The fluid inflator of  claim 1 , further comprising a tube coupled to the inflation lumen and to the shuttle chamber, the expandable member and inflation lumen being part of a balloon catheter. 
     
     
         3 . The fluid inflator of  claim 1 , further comprising a puncturing mechanism connected to the pressurized fluid source and including a puncture spear and a lever for engaging the puncture spear. 
     
     
         4 . The fluid inflator of  claim 1 , further comprising a mechanism for removing fluid from an expandable member of the balloon catheter. 
     
     
         5 . The fluid inflator of  claim 1 , wherein the pressure chamber further comprises an inlet port in fluid communication with the pressurized fluid source for filling the pressure chamber with a volume of fluid. 
     
     
         6 . The fluid inflator of  claim 2 , further comprising:
 a housing;   at least one control switch positioned on the housing and operable to control fluid flow within the inflation lumen.   
     
     
         7 . The fluid inflator of  claim 6 , wherein the at least one control switch further comprises an inflation button and a deflation button operably connected to the shuttle mechanism. 
     
     
         8 . The fluid inflator of  claim 7 , wherein the shuttle is operably connected to the inflation and deflation buttons and the shuttle mechanism further comprises:
 a series of seals mounted on the shuttle and spaced apart to divide the shuttle chamber into the pressure chamber and the vacuum chamber, wherein the vacuum chamber has a one way bypass seal for venting fluid from the vacuum chamber;   a vacuum piston operably connected to the one way bypass seal of the vacuum chamber;   a translation output connected to the inflation and deflation buttons for moving the shuttle longitudinally within the shuttle chamber.   
     
     
         9 . The fluid inflator of  claim 8 , wherein the series of seals are o-ring seals. 
     
     
         10 . The fluid inflator of  claim 9 , wherein the vacuum chamber is formed by one o-ring seal and the one-way venting seal spaced apart and the pressure chamber is formed by two or more o-ring seals spaced apart. 
     
     
         11 . The fluid inflator of  claim 8 , wherein the shuttle chamber includes a high pressure resistance outlet port and a low pressure resistance outlet port. 
     
     
         12 . The fluid inflator of  claim 11 , wherein the translation output for moving the shuttle longitudinally is configured to alternately place the pressure chamber in fluid communication with the pressurized fluid source and the high pressure resistance outlet port. 
     
     
         13 . The fluid inflator of  claim 2 , further comprising a venting system for regulating the pressure of the fluid delivered to the inflation lumen from the pressure chamber. 
     
     
         14 . The fluid inflator of  claim 13 , wherein the venting system further comprises at least one pressure relief valve for maintaining a constant delivery pressure to the inflation lumen. 
     
     
         15 . The fluid inflator of  claim 14 , further comprising a second pressure release valve. 
     
     
         16 . The fluid inflator of  claim 14 , wherein the at least one pressure valve comprises a spring-loaded poppet valve. 
     
     
         17 . The fluid inflator of  claim 14 , wherein the pressure relief valve further comprises a pressure indicator in fluid communication with the inflation lumen. 
     
     
         18 . The fluid inflator of  claim 2 , further comprising an in-line filter for sterilizing the fluid before delivery to the inflation lumen. 
     
     
         19 . The fluid inflator of  claim 1 , wherein the pressurized fluid source comprises a pressurized Carbon Dioxide. 
     
     
         20 . A fluid inflator comprising:
 a shuttle mechanism comprising:
 a shuttle chamber having a pressure chamber and a vacuum chamber; 
 a shuttle movable within the shuttle chamber; 
   wherein the shuttle is operable between a first position in which the pressure chamber is in flow communication with a vacuum source, a second position in which the pressure chamber is in flow communication with a pressurized fluid source, and a third position in which the pressure chamber is in flow communication with an inflation lumen of a vascular closure device.