System and device for minimizing embolic risk during an interventional procedure

Abstract

A device for trapping plaque against the vascular wall includes a tubular-shaped net which is made from a blood-permeable and biocompatable material having expandable members attached to each end of the tubular net. The expandable members are placed in their expanded position within a blood vessel to maintain the tubular net against the area of plaque to be treated with an interventional procedure. A balloon angioplasty procedure or stenting procedure is subsequently performed within the inner lumen formed in the tubular net. The tubular net prevents any emboli which may be created during the interventional procedure from entering into the bloodstream.

What is claimed:  
     
         1 . An intravascular device for trapping an area of plaque against the wall of a blood vessel to minimize the possibility of emboli from the plaque entering the bloodstream, comprising: 
 a permanently implantable tubular net having proximal and distal ends made from a flexible, blood permeable and biocompatible material; and    an expandable member attached to each of said proximal and distal ends of said tubular net which is capable of expanding to contact the wall of the blood vessel to maintain the tubular net over the area of plaque to be trapped to minimize the possibility of emboli formed from the plaque from entering the bloodstream.    
     
     
         2 . The intravascular device of  claim 1 , further including at least one strut attached to each of said expandable members for maintaining a set longitudinal distance between each of said expandable members.  
     
     
         3 . The intravascular device of  claim 1 , wherein each of said expandable members is an expandable ring.  
     
     
         4 . The intravascular device of  claim 3 , wherein each of said expandable rings is self-expanding.  
     
     
         5 . The intravascular device of  claim 1 , wherein each of said expandable members is a self-expanding arc.  
     
     
         6 . The intravascular device of  claim 1 , wherein each of said expandable members is a stent.  
     
     
         7 . The intravascular device of  claim 6 , wherein each of the stents is self-expanding.  
     
     
         8 . The intravascular device of  claim 1 , further including a plurality of struts attached to each of said expandable members to maintain a set longitudinal length between each expandable member.  
     
     
         9 . The intravascular device of  claim 8 , wherein each of said struts is attached to the tubular net.  
     
     
         10 . The intravascular device of  claim 8 , wherein each of said expandable members is made from a self-expanding material.  
     
     
         11 . The intravascular device of  claim 10 , wherein said tubular net is made from a material having a cell size of approximately 20 microns.  
     
     
         12 . The intravascular device of  claim 10 , wherein said tubular net is made from a material having a cell size of approximately 10-50 microns.  
     
     
         13 . A catheter for delivering a stent and a plaque-trapping device into a blood vessel, comprising: 
 an inner member having a first region for mounting a contracted stent which is expandable from a contracted to expanded condition and a second region for mounting a collapsed plaque-trapping device against the wall of a blood vessel; and    a retractable restraining sheath overlying said inner member adapted for axial movement with respect to said inner member for deploying said plaque-trapping device and stent in the blood vessel.    
     
     
         14 . The catheter of  claim 13 , wherein said inner member comprises a tubular member having a proximal and distal end, said distal end having said first and second mounting regions formed thereon.  
     
     
         15 . The catheter of  claim 13 , wherein said retractable restraining sheath has a proximal and distal end and is adapted for axial movement with respect to said inner member by moving said proximal end with respect to said inner member.  
     
     
         16 . The catheter of  claim 13 , wherein said second region for mounting the collapsed plaque-trapping device is located distal to said first region for mounting the contracted stent.  
     
     
         17 . The catheter of  claim 13 , wherein the first and second regions are substantially cylindrically shaped.  
     
     
         18 . The catheter of  claim 17 , wherein the diameter of the cylindrically shaped second region is less than the diameter of the cylindrically shaped first region.  
     
     
         19 . The catheter of  claim 18 , wherein said retractable restraining sheath conforms to the different diameters of said first and second mounting regions.  
     
     
         20 . The catheter of  claim 19 , wherein said first mounting region has a longitudinal length which is different from the longitudinal length of said second mounting region.  
     
     
         21 . The catheter of  claim 20 , wherein the longitudinal length of said second mounting region is smaller than the longitudinal length of said first mounting region.  
     
     
         22 . The catheter of  claim 13 , wherein the retractable restraining sheath has an elastic end portion which is designed to cover the collapsed plaque trapping device.  
     
     
         23 . A system for treating an area of plaque in a blood vessel and minimizing the possibility of emboli from the plaque entering the bloodstream, comprising: 
 a plaque-trapping device including a permanently implantable tubular net having proximal and distal ends and an inner lumen formed therein, said tubular net being made from a flexible, blood permeable and biocompatible material with an expandable member attached to each of said proximal and distal ends of said tubular net which is capable of expanding from a collapsed to an expanded condition to contact the wall of the blood vessel to maintain the tubular net over the area of plaque;    an implantable stent expandable from a contracted to an expanded condition and adapted for placement within the inner lumen of said tubular net for compressing the plaque when deployed into the expanded condition; and    a delivery catheter having an inner member with a first region for mounting said implantable stent when in the contracted condition and a second region for mounting said plaque-trapping device when in the collapsed condition, along with a retractable restraining sheath overlying said inner member adapted for axial movement with respect to said inner member for deploying said plaque-trapping device and stent in the blood vessel.    
     
     
         24 . The system of  claim 23 , wherein said expandable members of said plaque-trapping device are made from self-expanding material.  
     
     
         25 . The system of  claim 24 , wherein said implantable stent is made from a self-expanding material.  
     
     
         26 . The system of  claim 25 , wherein said first and second mounting regions of said delivery catheter have a substantially cylindrical shape and the diameter of said second mounting region is smaller then the diameter of said first mounting region.  
     
     
         27 . The system of  claim 26 , wherein said plaque-trapping device has a longitudinal length and said implantable stent has a longitudinal length with the longitudinal length of said plaque-trapping device being less than the longitudinal length of said implantable stent.  
     
     
         28 . The system of  claim 27 , wherein said plaque-trapping device includes a plurality of struts attached to each of said expandable members to maintain a set longitudinal length between each of said expandable members.  
     
     
         29 . A method for treating an area of plaque in a blood vessel and minimizing the possibility of emboli from the plaque entering the bloodstream, comprising: 
 placing a plaque-trapping device having a permanently implantable tubular net with an inner lumen into the blood vessel to contact the area of plaque to minimize the possibility of emboli from the plaque entering the bloodstream;    placing a contracted stent which is expandable from a contracted to an expanded condition into at least a portion of the inner lumen of said tubular net; and    expanding the contracted stent into the expanded condition to compress the area of plaque in the blood vessel.    
     
     
         30 . The method of  claim 29 , wherein said tubular net is made from a blood-permeable and biocompatable material.  
     
     
         31 . The method of  claim 30 , wherein a single delivery catheter having a first region for mounting the contracted stent and a second region for mounting the collapsed plaque-trapping device is utilized for delivering and placing said plaque-trapping device and stent into the body vessel.  
     
     
         32 . An intravascular device for trapping an area of plaque against the wall of a blood vessel to minimize the possibility of emboli from the plaque entering the bloodstream, comprising: 
 a permanently implantable tubular net having proximal and distal ends made from a flexible, blood permeable and biocompatible material; and    an expandable member attached to each of said proximal and distal ends of said tubular net which is capable of expanding to contact the wall of the blood vessel to maintain the tubular net over the area of plaque to be trapped to minimize the possibility of emboli from the plaque entering the bloodstream; and    means for maintaining for maintaining a set longitudinal distance between each of said expandable members.    
     
     
         33 . The intravascular device of  claim 32  wherein the means for maintaining a set longitudinal distance between each of said expandable members includes at least one strut attached to the expandable members.  
     
     
         34 . The intravascular device of  claim 1 , wherein each of said expandable members is an expandable ring.