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 . An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising: 
 a shaft member having a distal and a proximal end; and    a filtering assembly rotatably mounted on the shaft member near the distal end thereof, the filtering assembly including an expandable strut assembly and a filter attached to the strut assembly for capturing embolic debris, the filtering assembly being mounted on an outer tubular member which is coaxially disposed over an inner tubular member having a length shorter than the outer tubular member, wherein one end of the inner tubular member is adapted to abut against the stop fitting located on the shaft member for limiting axial movement of the filtering assembly along the guide wire.    
     
     
         2 . The embolic protection device of  claim 1 , wherein: 
 the shaft member is a guide wire and includes a distal spring tip coil, the spring tip coil serving as the stop fitting which abuts against the inner tubular member.    
     
     
         3 . The embolic protection device of  claim 2 , wherein: 
 the guide wire includes a second stop fitting in an abutting relationship with the proximal ends of the outer and inner tubular members.    
     
     
         4 . The embolic protection device of  claim 2 , wherein: 
 the outer tubular member extends over a portion of the spring tip coil of the guide wire.    
     
     
         5 . The embolic protection device of  claim 2 , wherein: 
 the outer and inner tubular members are made from polyimide.    
     
     
         6 - 31 . (Canceled).  
     
     
         32 . An embolic protection device for capturing embolic debris released into the body vessel of a patient, comprising: 
 a shaft member having a distal end and a proximal end;    a filtering element mounted on the shaft member near the distal end thereof, the filtering element including an expandable strut assembly and a filter attached to the strut assembly for capturing embolic debris, and    a layer of polymeric material having a coefficient of friction less than the coefficient of friction of the material of the strut assembly deposited on at least part of the strut assembly proximal to the filter.    
     
     
         33 . The embolic protection device of  claim 32 , wherein: 
 the polymeric material is selected from the group consisting of PTFE, polyimide, and heparin.    
     
     
         34 . The embolic protection device of  claim 32 , wherein: 
 the entire strut assembly is coated with the polymeric material.    
     
     
         35 . The embolic protection device of  claim 34 , wherein: 
 the polymeric material is selected from the group consisting of PTFE, polyimide, and heparin.    
     
     
         36 . An embolic protection device for capturing embolic debris released into the body vessel of a patient, comprising: 
 a shaft member having a distal end and a proximal end;    a filtering element mounted on the shaft member near the distal end thereof, the filtering element including an expandable strut assembly and a filter attached to the strut assembly for capturing embolic debris, the expandable strut assembly being movable between an expanded position and an unexpanded position and having regions which experience high strain and regions which experience low strain during movement between the unexpanded position and the expanded position; and    a layer of polymeric material deposited on the regions which experience low strain, the layer of polymeric material having a coefficient of friction less than the coefficient of friction of the material forming the strut assembly.    
     
     
         37 . The embolic protection device of  claim 36 , wherein the polymeric material is selected from the group consisting of PTFE and polyimide.  
     
     
         38 . An embolic protection device for capturing embolic debris released into the body vessel of a patient, comprising: 
 a shaft member having a distal end and a proximal end;    a filtering element mounted on the shaft member near the distal end thereof, the filtering element including an expandable strut assembly and a filter attached to the strut assembly for capturing embolic debris, and    a coating made from a substance having a coefficient of friction less than the coefficient of friction of the material forming the strut assembly selectively deposited on portions of the strut assembly proximal to the filter.    
     
     
         39 . The embolic protection device of  claim 38 , wherein the coating substance is a hydrophilic substance.  
     
     
         40 . The embolic protection device of  claim 38 , wherein the coating substance is heparin.