Intravascular Device With Multiple Leaflets

Abstract

This invention relates to devices that are inserted in a blood vessel or other body lumen, and in particular to filter that may block particles from entering a blood vessel. Devices of this invention position and secure a filter in a vascular system to intercept particulates, including emboli.

1 . An intravascular device to prevent a particle in the aorta from passing into a second blood vessel, said device comprising:
 a. a primary frame comprising:
 i. an elongated wire having a first end and a second end, 
 ii. two or more supporting elements, each of said supporting elements attached to said first end of said wire, and 
 iii. at least one expanding element attached to said wire between said first end and said second end and configured to reversibly extend away from said wire, 
   b. a filter comprising:
 i. a distal end and a proximal end, and 
 ii. two or more leaflets, each of said leaflets comprising a first attachment portion, a second attachment portion, and a filter material having pores which are both large enough to allow blood to pass through and small enough to prevent a particle from passing through said filter, 
   wherein said supporting elements are attached to said first attachment portion of said leaflets and define the distal end of said filter, said second end of said wire is attached to said second attachment portion of said leaflets and define said proximal end of said filter, said two or more leaflets are configured to overlap with an adjacent leaflet to form a continuous filter surface, and said expanding element is configured to contact and support said filter upon expansion; such that when said intravascular device is deployed in an aortic arch, said elongated wire contacts a superior surface of said aortic arch, said distal end of said filter expands to fill the aorta and said proximal end of said filter converges to an apex, thereby preventing the bypass of fluid around said filter material and preventing a particle in the aorta from passing into a second blood vessel.   
     
     
         2 . The device of  claim 1 , wherein said expanding element is configured to apply a first force to said leaflets upon expansion thereby forming a continuous filter surface and continuous contact and/or a seal of said leaflets with surfaces of an aorta. 
     
     
         3 . The device of  claim 1 , wherein said supporting elements are configured to apply a second force to said leaflets, said second force maintaining a continuous filter surface and contacting said leaflets with an adjacent leaflet, thereby forming a seal between said leaflets. 
     
     
         4 . The device of  claim 1 , wherein said wire comprises a metal, metal alloy, shape memory material, plastic, polymer, silicone, ceramic, or a composite thereof. 
     
     
         5 . The device of  claim 1 , wherein said supporting elements comprise two loops, chains, wires, fibers, or combinations thereof. 
     
     
         6 . The device of  claim 1 , wherein said supporting elements comprise a rigid, semi-rigid, or flexible material. 
     
     
         7 . The device of  claim 1 , wherein said supporting elements comprise two or more wires having a proximal end and a distal end, said proximal end attached to said first end of said wire and said distal end attached to said first attachment portion of said leaflets. 
     
     
         8 . The device of  claim 1 , wherein said supporting elements comprise a metal, metal alloy, shape memory material, plastic, polymer, silicone, ceramic, or a composite thereof. 
     
     
         9 . The device of  claim 1 , wherein said expanding element comprises a flexible semi-rigid material. 
     
     
         10 . The device of  claim 1 , wherein said expanding element comprises one or more loops, twisted loops, circular elements, semi-circular elements, or ovular elements. 
     
     
         11 . The device of  claim 1 , wherein said expanding element comprises a single flexible or semi-rigid loop. 
     
     
         12 . The device of  claim 1 , wherein said expanding element is reversibly extended by activation from said wire or a controllable catheter. 
     
     
         13 . The device of  claim 1 , wherein said expanding element is reversibly extended by twisting said wire or a controllable catheter. 
     
     
         14 . The device of  claim 1 , wherein said first attachment portion of said leaflet comprises a grommet. 
     
     
         15 . The device of  claim 1 , wherein said second attachment portion of said leaflet is affixed to said second end of said wire by an adhesive. 
     
     
         16 . The device of  claim 1 , wherein said filter is configured to be contracted during implantation and expanded upon deployment. 
     
     
         17 . The device of  claim 1 , wherein at least a portion of one leaflet wraps around said wire of said primary frame. 
     
     
         18 . The device of  claim 1 , wherein said filter material comprises a pore size between about 50 microns (μm) to about 1000 μm. 
     
     
         19 . The device of  claim 1 , wherein said filter material comprises a plurality of woven fibers. 
     
     
         20 . The device of  claim 1 , wherein said filter material comprises a mesh. 
     
     
         21 - 91 . (canceled)