Embolic protection devices

Abstract

An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. In one embodiment, the filtering assembly is attached to the distal end of a guide wire and is deployed within the patient's vasculature as the guide wire is manipulated into the area of treatment. A restraining sheath placed over the filtering assembly in a coaxial arrangement maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Thereafter, the sheath can be retracted to expose the filtering assembly which will then self-expand within the patient's vasculature. Interventional devices can be delivered over the guide wire and any embolic debris created during the interventional procedure and released into the blood stream will enter the filtering assembly and be captured therein. Other embodiments include filtering assemblies attached to an outer tubular member and inner shaft member which apply axial force to the distal ends of the assembly to either expand or contract the struts as needed.

1 - 41 . (canceled)  
   
   
       42 . An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising: 
 an elongate member;    a filter rotatably mounted on the elongate member and movable between a collapsed position and an expanded position, the filter having a proximal end and a distal end and having a proximal opening and a plurality of outlet openings, the outlet openings allowing body fluid to flow therethrough but retain embolic material;    a stop fitting attached to the elongate member;    a proximal tubular member, the elongate member extending through the proximal tubular member and being rotatable relative to the proximal tubular member, the proximal end of the filter being mounted on the proximal tubular member, the proximal tubular member being adapted to abut against the stop fitting to prevent the proximal end of the filter from moving distally beyond the stop fitting; and    a distal tubular member, the elongate member extending through the distal tubular member and being rotatable relative to the distal tubular member, the distal end of the filter being mounted on the distal tubular member.    
   
   
       43 . The embolic protection device of  claim 42 , wherein the distal tubular member is slidable along at least a portion of the elongate member.  
   
   
       44 . The embolic protection device of  claim 42 , wherein the proximal tubular member is made from polyimide.  
   
   
       45 . The embolic protection device of  claim 42 , wherein the distal tubular member is made from polyimide.  
   
   
       46 . The embolic protection device of  claim 42 , wherein a portion of the distal tubular member extends distally beyond the distal end of the filter.  
   
   
       47 . The embolic protection device of  claim 46 , further including an obturator attached to the portion of the distal tubular member which extends distally beyond the distal end of the filter.  
   
   
       48 . The embolic protection device of  claim 42 , wherein a portion of the distal proximal tubular member extends proximally from the distal end of the filter.  
   
   
       49 . The embolic protection device of  claim 48 , wherein the proximal end of the distal tubular member is adapted to abut against the stop fitting to prevent the distal end of the filter from moving proximally past the stop fitting.  
   
   
       50 . The embolic protection device of  claim 42 , wherein movement of the distal tubular member relative to the proximal tubular member moves the filter between the collapsed position and the expanded position.  
   
   
       51 . The embolic protection device of  claim 42 , wherein the distal end of the filter is mounted to the outer surface of the distal tubular member.  
   
   
       52 . The embolic protection device of  claim 42 , wherein the proximal end of the filter is mounted to the outer surface of the proximal tubular member.  
   
   
       53 . The embolic protection device of  claim 42 , wherein the elongate member is a guide wire.  
   
   
       54 . An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising: 
 an elongate member;    a filter made from a self-expanding material mounted on the elongate member and movable between a collapsed position and an expanded position, the filter having a proximal end and a distal end and a proximal opening for receiving body fluid therethrough and a plurality of outlet openings, the outlet openings allowing body fluid to flow therethrough but retain embolic material;    a stop fitting attached to the elongate member;    a proximal tubular member, the elongate member extending through the proximal tubular member and being rotatable relative to the proximal tubular member, the proximal end of the filter being mounted on the proximal tubular member, the proximal tubular member being adapted to abut against the stop fitting to prevent the proximal end of the filter from moving distally beyond the stop fitting; and    a distal tubular member made from a length of polyimide tubing, the elongate member extending through the distal tubular member and being rotatable relative to the distal tubular member, the distal end of the filter being mounted on the distal tubular member and at least a portion of the distal tubular member is slidable over at least a portion of the elongate member.    
   
   
       55 . The embolic protection device of  claim 54 , wherein a portion of the distal tubular member extends distally beyond the distal end of the filter.  
   
   
       56 . The embolic protection device of  claim 55 , further including an obturator attached to the portion of the distal tubular member which extends distally beyond the distal end of the filter.  
   
   
       57 . The embolic protection device of  claim 55 , wherein a portion of the distal proximal tubular member extends proximally away from the distal end of the filter.  
   
   
       58 . The embolic protection device of  claim 57 , wherein the proximal end of the distal tubular member is adapted to abut against the stop fitting to prevent the distal end of the filter from moving proximally past the stop fitting.  
   
   
       59 . The embolic protection device of  claim 54 , wherein the filter is made from a nickel-titanium alloy.  
   
   
       60 . The embolic protection device of  claim 54 , wherein the portion of the filter which includes the plurality of outlet openings is made from a mesh material.