Device to create proximal stasis

Abstract

A method and system of performing an intravascular procedure at a treatment site in a vessel of a patient. A device creates a seal to prevent the flow of blood during the treatment of vascular disease. A seal may be formed between the distal inside diameter of a sheath or catheter such as a guide catheter as well as within a vessel, such as an artery or vein. An elongated device having a distal portion extending from the catheter and having a fluid impermeable membrane disposed about at least the distal end of the device is used to seal the vessel. The system includes a device to occlude blood flow and a distal protection device to filter or remove embolic debris.

1 . A system for occluding the flow of blood in a vessel of a human vascular system comprising: 
 a catheter having proximal and distal ends and a lumen; and    a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter, wherein the distal sealing portion comprises an expansion control section having a restraining member.    
   
   
       2 . The system of  claim 1 , wherein the expansion control section further comprises an expansion member.  
   
   
       3 . The system of  claim 1 , wherein the restraining member is oriented longitudinally.  
   
   
       4 . The system of  claim 2 , wherein the expansion member comprises a spring.  
   
   
       5 . The system of  claim 2 , wherein the restraining member is connected to the expansion member.  
   
   
       6 . The system of  claim 1 , wherein the expansion member is positioned distally of the restraining member.  
   
   
       7 . The system of  claim 1 , wherein the restraining member comprises a wire.  
   
   
       8 . The system of  claim 1 , wherein the restraining member comprises a wire ribbon.  
   
   
       9 . The system of  claim 1 , wherein the sealing device comprises metal wire.  
   
   
       10 . The system of  claim 9 , wherein the metal wire comprises nitinol.  
   
   
       11 . The system of  claim 1 , wherein the sealing device comprises a flexible membrane.  
   
   
       12 . The system of  claim 1 , wherein the sealing device further comprises a control element connected adjacent at least one of the distal and proximal ends of the sealing device.  
   
   
       13 . The system of  claim 12 , wherein the control element comprises a control wire.  
   
   
       14 . The system of  claim 12 , wherein the control element comprises a tube.  
   
   
       15 . The system of  claim 12 , wherein the control element comprises an elongate proximal portion of the sealing device having a length sufficient to extend outside the patient during advancement of the sealing device.  
   
   
       16 . The system of  claim 1 , wherein the sealing device comprises at least one flow window between the lumen of the sealing device and an exterior surface of the sealing device.  
   
   
       17 . The system of  claim 1 , wherein the proximal sealing portion comprises a spring wire.  
   
   
       18 . The system of  claim 1 , wherein the proximal sealing portion comprises open cell foam.  
   
   
       19 . A system for protecting a patient from emboli released during an intravascular procedure performed at a treatment site in a vessel of a patient comprising: 
 a guide catheter having proximal and distal ends and a lumen;    a sealing device having a distal sealing portion and a proximal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the guide catheter and the distal sealing portion being sized to seal against the wall of the vessel at a location proximal to the treatment site when the distal sealing portion is extended from the distal end of the guide catheter, wherein the distal sealing portion comprises an expansion control section having a restraining member; and    a distal protection device sized to be delivered through the lumens of the guide catheter and sealing device to a location in the vessel distal to the treatment site.    
   
   
       20 . A system for protecting a patient from emboli released during an intravascular procedure performed at a treatment site in a vessel of a patient comprising: 
 a guide catheter having proximal and distal ends and a lumen;    a sealing device having a distal sealing portion and a proximal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the guide catheter and the distal sealing portion being sized to seal against the wall of the vessel at a location proximal to the treatment site when the distal sealing portion is extended from the distal end of the guide catheter, wherein the distal sealing portion comprises an expansion control section having a restraining member;    a delivery catheter having distal and proximal ends and a lumen, the delivery catheter being sized to be delivered through the lumens of the guide catheter and sealing device to a location in the vessel where its distal end is distal to the treatment site; and    an elongate support member carrying an embolic protection device, the elongate support member and embolic protection device being sized to be slideably accommodated within the lumen of the delivery catheter, the embolic protection device being expandable from a delivery configuration when contained within the delivery catheter to a deployed configuration when extended from the distal end of the delivery catheter.    
   
   
       21 . A system for creating retrograde flow of blood in a vessel of a human vascular system comprising: 
 a catheter having proximal and distal ends and a lumen and a valve connected at the proximal end for opening and closing the lumen of the catheter to fluid flow; and    a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter, wherein the distal sealing portion comprises an expansion control section having a restraining member.    
   
   
       22 . A system for creating retrograde flow of blood in a vessel of a human vascular system comprising: 
 a catheter having proximal and distal ends and a lumen;    a suction device connected to the lumen of the catheter; and    a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter, wherein the distal sealing portion comprises an expansion control section having a restraining member.    
   
   
       23 . A system for occluding the flow of blood in a vessel of a human vascular system comprising: 
 a catheter having proximal and distal ends and a lumen; and    a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter, wherein the sealing device comprises at least one flow window between the lumen of the sealing device and an exterior surface of the sealing device.