Bifurcated endoluminal prosthesis

Abstract

An introducer for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method for delivering into the vasculature a straight or bifurcated stent or prosthesis; a method of treating and angeological disease using a bifurcated stent; an endoluminal stent having perpendicular hoop members, each hoop member formed of wire in a sinuous configuration, at least some of juxtaposed apices in neighboring hoops being secured to one another, such stents also forming axially aligned segments in straight stents, and segments of bifurcated stents in particular embodiments. Certain embodiments of such stents also include barbs, fabric covering and radiopaque markers.

What is claimed:  
     
         1 . An introducer for delivering, into the vasculature at an angeological bifurcation where a blood vessel branches into two branched vessels, a bifurcated endoluminal stent or prosthesis having a proximal portion adapted to be disposed in said blood vessel and a distal portion adapted to be disposed at least partially in one of said two branched vessels, said introducer comprising: 
 (a) a tubular outer sheath;    (b) a proximal portion pusher disposed at least partially within said outer sheath; and    (c) a distal portion pusher disposed at least partially within said proximal portion pusher.    
     
     
         2 . An introducer for delivering a bifurcated endoluminal stent or prosthesis as claimed in  claim 1  further comprising a balloon catheter, having a balloon attached thereto, disposed at least partially within said distal portion pusher.  
     
     
         3 . An introducer for delivering a bifurcated endoluminal stent or prosthesis as claimed in  claim 2  further comprising a hemostasis valve attached to the distal end of said distal portion pusher.  
     
     
         4 . An introducer for delivering a bifurcated endoluminal stent or prosthesis as claimed in  claim 2  further comprising wings on said outer sheath and said proximal portion pusher.  
     
     
         5 . An introducer for delivering a bifurcated endoluminal stent or prosthesis as claimed in  claim 2 , wherein said balloon catheter has an injection orifice and an injection conduit therein.  
     
     
         6 . An introducer for delivering a bifurcated endoluminal stent or prosthesis as claimed in  claim 2 , wherein said balloon catheter has an inflation orifice and an inflation conduit therein.  
     
     
         7 . An introducer for delivering a bifurcated endoluminal stent or prosthesis as claimed in  claim 2 , wherein said balloon catheter has a proximal end with a nose cone attached thereto.  
     
     
         8 . An introducer for delivering into the vasculature at an angeological bifurcation where a blood vessel branches into two branched vessels, an endoluminal prosthesis having a proximal stent portion and a distal stent portion, said introducer comprising: 
 (a) a tubular outer sheath;    (b) a proximal portion pusher disposed at least partially within said outer sheath and having a proximal end adapted to contact said proximal stent portion;    (c) a distal portion pusher disposed at least partially within said proximal portion pusher and having a proximal end adapted to contact said distal stent portion; and    (d) a balloon catheter, having a balloon attached thereto, disposed at least partially within said distal portion pusher.    
     
     
         9 . An introducer for delivering an endoluminal stent into the vasculature at an angeological bifurcation where a blood vessel branches into two branched vessels, said introducer comprising: 
 (a) a tubular outer sheath;    (b) a proximal portion pusher disposed at least partially within said outer sheath and having a proximal end adapted to contact a distal end of said stent; and    (c) a distal portion pusher disposed at least partially within said proximal portion pusher and secured to said proximal portion pusher such that proximal ends of said distal portion pusher and said proximal portion pusher are flush with one another.    
     
     
         10 . A method for delivering a bifurcated endoluminal stent or prosthesis having a proximal portion and a first distal portion into the vasculature at an angeological bifurcation where a blood vessel branches into a first branched vessel and a second branched vessel, said method comprising the steps of: 
 (a) inserting a first introducer containing said stent or prosthesis into the vasculature to a predetermined delivery location, said first introducer comprising an outer sheath, a proximal portion pusher, and a distal portion pusher;    (b) withdrawing said outer sheath of said first introducer while maintaining said proximal portion pusher in a fixed position until said proximal portion of said stent or prosthesis is deployed from said first introducer into said blood vessel;    (c) withdrawing said outer sheath and said proximal portion pusher while maintaining said distal portion pusher in a fixed position until said first distal portion of said stent or prosthesis is deployed from said first introducer at least partially into said first branched vessel; and    (d) withdrawing said first introducer from the vasculature.    
     
     
         11 . A method for delivering a bifurcated endoluminal stent or prosthesis as claimed in  claim 10  further comprising the steps of: 
 (a) inserting into the vasculature a second introducer containing a second distal portion of said stent or prosthesis and comprising an outer sheath and a pusher;  
 (b) withdrawing said outer sheath of said second introducer while maintaining said pusher of said second introducer in a fixed position until said second distal portion of said stent or prosthesis is deployed from said second introducer such that a proximal end of said second distal portion securely connects to said proximal portion of said stent or prosthesis, and such that a distal end of said second distal portion extends at least partially into said second branched vessel; and  
 (c) withdrawing said second introducer from the vasculature.  
 
     
     
         12 . A method for delivering a bifurcated endoluminal stent or prosthesis as claimed in  claim 10  wherein said first introducer further comprises a balloon catheter having a balloon attached thereto and said method further comprises the step of inflating said balloon to at least partially block blood flow in said blood vessel after inserting said first introducer into the vasculature.  
     
     
         13 . A method for delivering, into the vasculature at an angeological bifurcation where a blood vessel branches into two branched vessels, an endoluminal prosthesis having a proximal stent portion, and a distal stent portion, said method comprising the steps of: 
 (a) inserting an introducer containing said prosthesis into the vasculature to a predetermined delivery location, said introducer comprising an outer sheath, a proximal stent portion pusher, a distal stent portion pusher, and a balloon catheter having a balloon attached thereto;    (b) inflating said balloon to at least partially block blood flow in said blood vessel;    (c) withdrawing said outer sheath of said introducer while maintaining said proximal stent portion pusher in a fixed position until said proximal stent portion of said prosthesis is deployed from said introducer into said blood vessel;    (d) withdrawing said outer sheath and said proximal stent portion pusher while maintaining said distal stent portion pusher in a fixed position until said distal stent portion of said prosthesis is deployed from said introducer into said blood vessel; and    (e) withdrawing said introducer from the vasculature.    
     
     
         14 . A method of treating an angeological disease at a bifurcation site where a blood vessel branches into a first branched vessel and a second branched vessel comprising the steps of: 
 (a) disposing in said blood vessel a proximal portion of an endoluminal stent;    (b) directing blood flow from said blood vessel into said first branched vessel through a first distal portion of said endoluminal stent, said first distal portion being connected to said proximal portion and extending into said first branched vessel; and    (c) directing blood flow from said blood vessel into said second branched vessel through a second distal portion of said endoluminal stent, said second distal portion being connected to said proximal portion and extending into said second branched vessel.    
     
     
         15 . A method of treating an angeological disease at a bifurcation site where a blood vessel branches into a first branched vessel and a second branched vessel as claimed in  claim 14  wherein said disease is stenosis.  
     
     
         16 . A method of treating an angeological disease at a bifurcation site where a blood vessel branches into a first branched vessel and a second branched vessel as claimed in  claim 14  that further comprises covering any of said proximal portion, said first distal portion, and said second distal portion with fabric.  
     
     
         17 . A method of treating an angeological disease at a bifurcation site where a blood vessel branches into a first branched vessel and a second branched vessel as claimed in  claim 16  wherein said disease is an aneurysm.  
     
     
         18 . A method of treating an angeological disease at a bifurcation site where a blood vessel branches into a first branched vessel and a second branched vessel as claimed in  claim 16  wherein said disease is an occlusion.  
     
     
         19 . An endoluminal stent comprising a plurality of hoops which are axially displaced in a tubular configuration along a common axis, each of said hoops 
 (a) being formed by a substantially complete turn of a sinuous wire having apices, and    (b) having a circumference that lies in a plane substantially perpendicular to the longitudinal axis of said stent;    wherein apices of adjacent hoops are juxtaposed to one another, and at least two juxtaposed apices are connected by a securing means.    
     
     
         20 . A stent as recited in  claim 19  in combination with one or more additional stent segments.  
     
     
         21 . A stent as recited in  claim 20  wherein at least one of said additional stent segments comprises a plurality of hoops which are axially displaced in a tubular configuration along a common axis, each of said hoops 
 (a) being formed by a substantially complete turn of a sinuous wire having apices, and  
 (b) having a circumference that lies in a plane substantially perpendicular to the longitudinal axis of said stent;  
 wherein apices of adjacent hoops are juxtaposed to one another, and at least two juxtaposed apices are connected by a securing means.  
 
     
     
         22 . A stent as recited in  claim 20  wherein said one or more additional segments are axially aligned with one another.  
     
     
         23 . A stent as recited in  claim 20  wherein said one or more additional segments are secured to one another by connecting means connecting at least some of the apices of hoops at mating ends of said stent and said additional segments.  
     
     
         24 . A stent as recited in  claim 20  wherein adjacent hoops are of the same diameter.  
     
     
         25 . A stent as recited in  claim 20  wherein adjacent hoops are of a different diameter.  
     
     
         26 . A stent as recited in  claim 22  wherein said axially aligned segments are connected to one another by a tubular fabric element.  
     
     
         27 . A stent as recited in  claim 20  wherein a first additional segment is axially parallel to, but non-common co-axial with, said stent.  
     
     
         28 . A stent as recited in  claim 27  further comprising a second additional segment axially parallel to said stent, but non-co-axial with either said stent or said first additional stent segment.  
     
     
         29 . A stent as recited in  claim 28  wherein at least one of said additional stent segments is of frustoconical shape and is further combined with an additional stent segment, one end of which includes a mating frustoconical shape.  
     
     
         30 . A stent as recited in  claim 29 , wherein said mating frustoconical stent segments are adapted to be separately placed in a bifurcated artery and then, by expansion of one of said frustoconical stent segments, secured to one another  
     
     
         31 . An endoluminal stent as claimed in  claim 19  wherein said hoops are formed of a single continuous wire.  
     
     
         32 . An endoluminal stent as claimed in  claim 19  wherein said securing means is a suture.  
     
     
         33 . An endoluminal stent as claimed in  claim 32  wherein said suture is a tied loop of thermoplastic material.  
     
     
         34 . An endoluminal stent as claimed in  claim 19  wherein said securing means is a ring.  
     
     
         35 . An endoluminal stent as claimed in  claim 19  wherein said securing means is a staple.  
     
     
         36 . An endoluminal stent as claimed in  claim 19  wherein said securing means is wire twisted into loop.  
     
     
         37 . An endoluminal stent as claimed in  claim 36  wherein said wire is nitinol.  
     
     
         38 . An endoluminal stent as claimed in  claim 19  wherein said securing means is bead of thermoplastic material.  
     
     
         39 . An endoluminal stent as claimed in  claim 19  wherein the plane of the circumference at each longitudinal end of the stent is square to the longitudinal axis of the stent.  
     
     
         40 . An endoluminal stent as claimed in  claim 19  wherein said stent is at least partially covered in fabric.  
     
     
         41 . An endoluminal stent as claimed in  claim 31  wherein said wire is nitinol.  
     
     
         42 . A method of making an endoluminal stent having a plurality of hoops which are axially displaced in a tubular configuration, each of said hoops being formed by a substantially complete turn of a sinuous wire with apices and having a circumference that lies in a plane substantially perpendicular to the longitudinal axis of the stent, said method comprising the steps of: 
 (a) winding a wire in a zig-zag pattern around a mandrel having a plurality of upstanding pins defining said zig-zag pattern to form a first hoop having apices and a circumference that lies in a plane substantially perpendicular to the longitudinal axis of said mandrel;    (b) longitudinally displacing said wire with respect to the axis of said mandrel;    (c) winding said wire in a zig-zag pattern around a plurality of upstanding pins on said mandrel to form a second hoop, adjacent said first hoop, having apices juxtaposed to the apices of said first circumferential hoop and a circumference that lies in a plane substantially perpendicular to the longitudinal axis of said mandrel;    (d) longitudinally displacing said wire with respect to the axis of said mandrel;    (e) repeating steps (a)-(d) to form additional hoops until a predetermined number of hoops are formed;    (f) annealing said wire on said mandrel;    (g) cooling said wire on said mandrel;    (h) removing said wire from said mandrel; and    (i) securing together at least two juxtaposed apices of adjacent hoops.    
     
     
         43 . An endoluminal stent comprising a radiopaque marker disposed on at least one end of the stent.  
     
     
         44 . An endoluminal stent as claimed in  claim 43  wherein said radiopaque marker comprises a radiopaque element attached to one end of said stent.  
     
     
         45 . An endoluminal stent as claimed in  claim 44  wherein said element is a platinum wire.  
     
     
         46 . An endoluminal stent as claimed in  claim 44  wherein said element is a gold wire.  
     
     
         47 . An endoluminal stent as claimed in  claim 43  wherein said radiopaque marker comprises a radiopaque tube disposed around a part of said stent.  
     
     
         48 . An endoluminal stent as claimed in  claim 47  wherein said tube is platinum.  
     
     
         49 . An endoluminal stent as claimed in  claim 47  wherein said tube is gold.  
     
     
         50 . A bifurcated stent for use in juxtaposition with an angeological bifurcation comprising a proximal stent portion adapted to be disposed within a blood vessel in juxtaposition with a bifurcation, a first distal stent portion adapted to extend across the bifurcation into one of the branched blood vessels, and a second distal stent portion adapted to allow blood to flow from the proximal portion into the other branched vessel and, at least one barb extending radially outward from any of said proximal stent portion, said first distal stent portion, and said second distal stent portion.  
     
     
         51 . Apparatus for delivering an endoluminal stent or prosthesis into the vasculature comprising: 
 (a) an introducer having a on a distal end thereof; and    (b) a cartridge having an inner tubular member containing said stent or prosthesis in a compressed state, an outer sheath, and a second portion of said lock fitting;    wherein said first portion of said lock fitting on said introducer mates with said second portion of said lock fitting on said cartidge to prevent relative movement of said introducer and said cartridge.    
     
     
         52 . Apparatus as claimed in  claim 51  wherein said lock fitting is a Luer lock.  
     
     
         53 . Apparatus as claimed in  claim 51  further comprising a hemostasis valve on said introducer and a pusher adapted to push said compressed stent or prosthesis through said cartridge, through said introducer, and into the vasculature.