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 gas inflator. The gas inflator is configured to be placed in fluid communication with the inflation lumen in order to provide a regulated pressure gas source for inflating the expandable member.

1 . A gas inflator comprising:
 a shuttle mechanism for delivering a bolus of gas to an expandable member via an inflation lumen having one or more outlet ports in communication with the inflation lumen; and   a high pressure gas source having an inlet port in fluid communication with the shuttle mechanism.   
     
     
         2 . The device of  claim 1 , wherein gas inflator further comprises a tube operably sized to connect with the proximal end of an inflation lumen and place the inflation lumen in fluid communication with the one or more outlet ports. 
     
     
         3 . The device of  claim 1 , wherein the gas inflator further comprises a puncturing mechanism connected to the high pressure gas cartridge, having a puncture spear and a lever for engaging the puncture spear. 
     
     
         4 . The device of  claim 1 , wherein the gas inflator further comprises a mechanism for removing gas from the expandable member. 
     
     
         5 . The device of  claim 4 , wherein the gas inflator further comprises:
 a housing; and   one or more control switches on the housing for controlling gas flow within the inflation lumen.   
     
     
         6 . The device of  claim 5 , wherein the control switch further comprises an inflation and a deflation button operably connected to the shuttle mechanism. 
     
     
         7 . The device of  claim 6 , wherein the shuttle mechanism further comprises:
 a cylindrical shuttle chamber in fluid communication with the one or more outlet ports and the high pressure gas source;   a shuttle operably connected to the inflation and deflation buttons;   a series of seals mounted on the shuttle and spaced apart to divide the shuttle chamber into a pressure chamber and a vacuum chamber, wherein the vacuum chamber has a one way bypass seal for venting gas from the vacuum chamber;   a vacuum piston operably connected to the one way bypass seal of the vacuum chamber; and   a translation output connected to the inflation and deflation buttons for moving the shuttle longitudinally within the shuttle chamber to alternately place the vacuum and pressure chambers in fluid communication with the outlet port and the pressure chamber in fluid communication with the high pressure gas source.   
     
     
         8 . The device of  claim 7 , wherein the pressure chamber further comprises an inlet port in fluid contact with the high pressure gas source for filling the pressure chamber with a bolus of gas. 
     
     
         9 . The device of  claim 7 , wherein the series of seals are o-ring seals. 
     
     
         10 . The device of  claim 9 , wherein the vacuum chamber is formed by one o-ring seal and the one-way venting seal spaced apart to define a chamber and the pressure chamber is formed by two or more o-ring seals spaced apart to define a chamber. 
     
     
         11 . The device of  claim 7 , wherein the one or more outlet ports further comprise a high pressure resistance outlet port and a low pressure resistance outlet port. 
     
     
         12 . The device of  claim 7 , wherein the translation output for moving the shuttle longitudinally further comprise a means for alternately placing the pressure chamber in fluid communication with the high pressure gas source and the high pressure resistance outlet port. 
     
     
         13 . The device of  claim 7 , wherein the gas inflator further comprises a venting system for regulating the pressure of the gas delivered to inflation lumen from the outlet port. 
     
     
         14 . The device 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 device of  claim 14 , further comprising a second pressure release valve. 
     
     
         16 . The device of  claim 14 , wherein the one or more pressure valves are spring-loaded poppet valves. 
     
     
         17 . The device of  claim 14 , wherein the pressure relief valve further comprises a pressure indicator in fluid communication with the inflation lumen and wherein the housing further comprises a window for viewing the pressure indicator. 
     
     
         18 . The device of  claim 2 , wherein the gas inflator further comprises an in line filter for sterilizing the gas before delivery to the inflation lumen. 
     
     
         19 . The device of  claim 1 , the high pressure gas source comprises a high pressure gas cartridge contains Carbon Dioxide. 
     
     
         20 . A gas inflator comprising:
 a shuttle mechanism for controlling gas 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; 
   a high pressure gas source;   a vacuum source;   wherein the shuttle is operable to alternately place the vacuum source in flow communication with the pressure chamber, the high pressure gas source in flow communication with the pressure chamber, and the pressure chamber in flow communication with the inflation lumen.