Stent-graft with positioning anchor

Abstract

A positioning anchor is provided for a stent-graft for implantation to treat a damaged body lumen. The positioning anchor is generally tubular surrounding a primary fluid conduit. Arms extend laterally from the generally tubular structure of the anchor surrounding lateral fluid conduits. The form of these arms is preferably custom configured to match a particular patient's luminal geometry. The anchor thus fits within the luminal geometry to remain in a desired fixed position for implantation of the anchor and any stent-graft coupled to the anchor. The anchor is most preferably formed with two walls having a void therebetween which can be filled with fixation media to further secure the anchor at the desired implantation site. A lumen shaper balloon and delivery catheter are also disclosed for proper delivery, expansion and inflation of the positioning anchor and stent-graft elements according to this invention.

What is claimed is:  
     
         1 - A double walled anchor for an intra-luminal stent-graft, comprising in combination: 
 an inner wall surrounding and defining a primary fluid conduit extending through said anchor;    an outer wall outboard from an exterior of said inner wall;    at least one void between said inner wall and said outer wall, said void adapted to be filled with fixation media; and    at least one of said walls having a contour generally defining an arm surrounding and defining at least one lateral fluid conduit joining with said primary fluid conduit.    
     
     
         2 - The double walled anchor of  claim 1  wherein said inner wall includes said contour generally defining said arm with said inner wall surrounding and defining said at least one lateral fluid conduit.  
     
     
         3 - The double walled anchor of  claim 2  wherein a portion of said outer wall is located outboard of said inner wall adjacent said arm with said lateral fluid conduit therein, said void extending between said outer wall and said inner wall within said arm.  
     
     
         4 - The double walled anchor of  claim 1  wherein fixation media is included within said at least one void.  
     
     
         5 - The double walled anchor of  claim 4  wherein said fixation media includes a gas.  
     
     
         6 - The double walled anchor of  claim 4  wherein said fixation media includes a liquid.  
     
     
         7 - The double walled anchor of  claim 4  wherein said fixation media includes a solid.  
     
     
         8 - The double walled anchor of  claim 4  wherein said fixation media includes a gel.  
     
     
         9 - The double walled anchor of  claim 4  wherein said fixation media includes a foam.  
     
     
         10 - The double walled anchor of  claim 1  wherein both said inner wall and said outer wall are formed from a material which is sufficiently flexible to allow said outer wall and said inner wall to be collapsed onto an elongate catheter beneath a sheath for intra-luminal implantation of said anchor.  
     
     
         11 - The double walled anchor of  claim 10  wherein both said inner wall and said outer wall are substantially inelastic.  
     
     
         12 - The double walled anchor of  claim 11  wherein said inner wall and said outer wall are each formed at least partially from parylene.  
     
     
         13 - The double walled anchor of  claim 12  wherein a liner is provided adjacent said inner wall and inboard of said inner wall, said liner including at least one opening adjacent said at least one lateral fluid conduit, such that fluid flow between said lateral fluid conduit and said primary fluid conduit can occur through said opening in said liner.  
     
     
         14 - The double walled anchor of  claim 12  wherein a liner is provided adjacent said inner wall and inboard of said inner wall, said liner being closed adjacent said at least one lateral fluid conduit, such that said liner blocks fluid flow between said lateral fluid conduit and said primary fluid conduit.  
     
     
         15 - The double walled anchor of  claim 1  wherein at least one interconnection is provided within said at least one void, said interconnection spanning said void between said inner wall and said outer wall, said at least one interconnection formed of a sufficiently inelastic material such that said interconnection controls expansion of said void when said void is filled with fixation media.  
     
     
         16 - The double walled anchor of  claim 15  wherein said at least one interconnection includes a plurality of quilting walls extending between said inner wall and said outer wall.  
     
     
         17 - The double walled anchor of  claim 15  wherein said at least one interconnection includes a plurality of quilting regions extending between said inner wall and said outer wall.  
     
     
         18 - The double walled anchor of  claim 1  wherein a substantially tubular graft is coupled to said anchor, said graft extending away from said anchor in a manner extending a length of said primary fluid conduit beyond said anchor and within said graft.  
     
     
         19 - The double walled anchor of  claim 18  wherein said graft includes an inner wall surrounding and defining said primary fluid conduit extending from said anchor and an outer wall outboard of said inner wall, said outer wall spaced from said inner wall by a void adapted to be filled with a fixation media.  
     
     
         20 - The double walled anchor of  claim 18  wherein said graft consists of a single wall surrounding and defining said primary fluid conduit extending from said anchor.  
     
     
         21 - The double walled anchor of  claim 1  wherein at least one radially expandable stent is located in a position circumferentially surrounding said arm surrounding and defining said at least one lateral fluid conduit, said stent having a first collapsed diameter and a second expanded diameter, said second expanded diameter having a greater diameter measurement than said first collapsed diameter, said stent adapted to be radially expanded to join said arm of said anchor to a lateral lumen near where the lateral lumen joins with a primary lumen within which said anchor is located, such that said anchor is at least partially held in place by said stent.  
     
     
         22 - A custom shaped anchor for an intra-luminal stent-graft, comprising in combination: 
 a first wall surrounding and defining a primary fluid conduit;    said primary fluid conduit including an inlet into said anchor and an outlet out of said anchor;    said first wall having a contour surrounding and defining at least one lateral fluid conduit joined with said primary fluid conduit within said first wall, such that fluids can pass between said primary fluid conduit and said lateral fluid conduit; and    said contour of said first wall having a particular geometry at least partially following a particular patient's luminal anatomy into which said anchor is adapted to be implanted.    
     
     
         23 - The custom shaped anchor of  claim 22  wherein said first wall has a contour surrounding and defining at least two lateral fluid conduits, said at least two lateral fluid conduits having a position relative to each other and a size which correspond with a particular patient's luminal anatomy into which said anchor is adapted to be implanted.  
     
     
         24 - The custom shaped anchor of  claim 22  wherein said first wall is an inner wall; 
 wherein said anchor includes an outer wall outboard from an exterior of said inner wall; and  
 wherein said anchor includes at least one void between said inner wall and said outer wall, said void adapted to be filled with a fixation media.  
 
     
     
         25 - The custom shaped anchor of  claim 24  wherein said inner wall includes said contour generally defining an arm with said inner wall surrounding and defining said at least one lateral fluid conduit.  
     
     
         26 - The custom shaped anchor of  claim 25  wherein at least one interconnection is provided within said at least one void, said interconnection spanning said void between said inner wall and said outer wall, said at least one interconnection formed of a sufficiently inelastic material such that said interconnection controls expansion of said void when said void is filled with fixation media.  
     
     
         27 - The custom shaped anchor of  claim 26  wherein said at least one interconnection includes a plurality of quilting walls extending between said inner wall and said outer wall.  
     
     
         28 - The custom shaped anchor of  claim 26  wherein said at least one interconnection includes a plurality of quilting regions extending between said inner wall and said outer wall.  
     
     
         29 - The custom shaped anchor of  claim 22  wherein a substantially tubular graft is coupled to said anchor, said graft extending away from said anchor in a manner extending a length of said primary fluid conduit beyond said anchor and within said graft.  
     
     
         30 - The custom shaped anchor of  claim 29  wherein said graft includes an inner wall surrounding and defining said primary fluid conduit extending from said anchor and an outer wall outboard of said inner wall, said outer wall spaced from said inner wall by a void adapted to be filled with a fixation media.  
     
     
         31 - The custom shaped anchor of  claim 29  wherein said graft consists of a single wall surrounding and defining said primary fluid conduit extending from said anchor.  
     
     
         32 - The custom shaped anchor of  claim 22  wherein at least one radially expandable stent is located in a position circumferentially surrounding said arm surrounding and defining said at least one lateral fluid conduit, said stent having a first collapsed diameter and a second expanded diameter, said second expanded diameter having a greater diameter measurement than said first collapsed diameter, said stent adapted to be radially expanded to join said arm of said anchor to a lateral lumen near where the lateral lumen joins with a primary lumen within which said anchor is located, such that said anchor is at least partially held in place by said stent.  
     
     
         33 - A method of forming a double walled anchor for an intra-luminal stent-graft, the double walled anchor having an inner wall surrounding and defining a primary fluid conduit extending through said anchor, an outer wall outboard from an exterior of said inner wall, and at least one void between said inner wall and said outer wall, said void adapted to be filled with fixation media, the steps including: 
 providing a sacrificial mandrel having a shape and size similar to the void of the double walled anchor;    forming a layer of anchor wall material on surfaces of the sacrificial mandrel; and    removing at least a portion of the sacrificial mandrel to form the void.    
     
     
         34 - The forming method of  claim 33  wherein said forming step includes the step of depositing the anchor wall material within a vacuum by vapor deposition.  
     
     
         35 - The forming method of  claim 34  wherein said depositing step includes the step of depositing parylene by vapor deposition within a vacuum.  
     
     
         36 - The forming method of  claim 33  wherein said forming step includes the step of dipping the sacrificial mandrel into a container with the anchor wall material therein.  
     
     
         37 - The forming method of  claim 33  wherein said forming step includes the step of spraying the anchor wall material onto the sacrificial mandrel.  
     
     
         38 - The forming method of  claim 33  wherein said removing step includes the step of dissolving the sacrificial mandrel.  
     
     
         39 - The forming method of  claim 33  wherein said removing step includes the step of chemically reacting the sacrificial mandrel with a reactant.  
     
     
         40 - The forming method of  claim 39  wherein said chemically reacting step includes the step of combusting the sacrificial mandrel with an oxidizer.  
     
     
         41 - The forming method of  claim 33  wherein said removing step includes the step of changing the phase of the sacrificial mandrel from a solid phase to a phase taken from the group consisting of a liquid phase and a gaseous phase.  
     
     
         42 - The forming method of  claim 33  wherein said providing a sacrificial mandrel step includes the step of positioning slots within the sacrificial mandrel which extend from an exterior surface of the sacrificial mandrel to an interior surface of the sacrificial mandrel, such that after said forming step and said removing step interconnections are provided between the inner wall and the outer wall of the double walled anchor at locations corresponding with locations of the slots in the sacrificial mandrel.  
     
     
         43 - The forming method of  claim 33  wherein said providing a sacrificial mandrel step is followed by the steps including: 
 cutting the sacrificial mandrel into a plurality of separate pieces;  
 coating the separate pieces;  
 reassembling the separate pieces; and  
 continuing to said forming step, said forming step reconnecting the separate pieces together.  
 
     
     
         44 - The forming method of  claim 33  including the further step of attaching a liner inboard of the inner wall of the anchor after said forming step.  
     
     
         45 - A method of forming a custom shaped anchor for an intra-luminal stent-graft, the anchor having a first wall surrounding and defining a primary fluid conduit, said contour of said first wall having a particular geometry at least partially following a particular patient's luminal anatomy into which said anchor is adapted to be implanted, the steps of the forming method including: 
 providing at least one molding surface having a contour following a particular geometry of a particular patient's luminal anatomy;    forming the first wall of the anchor against the mold surface; and    removing the mold surface from the first wall.    
     
     
         46 - The custom forming method of  claim 45  wherein said providing step includes the steps of: 
 imaging at least a portion of the patient's luminal anatomy;  
 creating a data file corresponding to the patient's luminal anatomy;  
 building a patient luminal anatomy model from the data in the data file; and  
 constructing the molding surface from the model of said building step.  
 
     
     
         47 - The custom forming method of  claim 46  wherein said imaging step includes the step of using a computer tomography (CT) scanning apparatus.  
     
     
         48 - The custom forming method of  claim 46  wherein said imaging step includes the step of using an x-ray imaging device.  
     
     
         49 - The custom forming method of  claim 46  wherein said imaging step includes the step of using an ultrasound imaging device.  
     
     
         50 - The custom forming method of  claim 46  wherein said imaging step includes the step of using a magnetic resonance imaging (MRI) device.  
     
     
         51 - The custom forming method of  claim 45  wherein said providing step includes providing a sacrificial mandrel having a shape and size similar to a void between inner and outer walls of the anchor; and removing at least a portion of the sacrificial mandrel to form the void, such that a double walled anchor is formed having a void between the two walls thereof.  
     
     
         52 - The custom forming method of  claim 45  wherein said forming step includes the step of dipping the molding surface into material from which the first wall of the anchor is to be formed.  
     
     
         53 - The custom forming method of  claim 45  wherein said forming step includes the step of spraying material from which the first wall of the anchor is to be made against the molding surface.  
     
     
         54 - The custom forming method of  claim 45  wherein said forming step includes the step of locating the molding surface within a vacuum and depositing by vapor deposition material from which the first wall of the anchor is to be made against the molding surface.  
     
     
         55 - The custom forming method of  claim 54  wherein said depositing step includes the step of depositing parylene by vapor deposition against the molding surface.  
     
     
         56 - The custom forming method of  claim 51  wherein said removing step includes the step of dissolving the sacrificial mandrel.  
     
     
         57 - The custom forming method of  claim 51  wherein said removing step includes the step of chemically reacting the sacrificial mandrel with a reactant.  
     
     
         58 - The custom forming method of  claim 51  wherein said removing step includes the step of melting the sacrificial mandrel.  
     
     
         59 - A method for deploying a double walled anchor intra-luminally, the double walled anchor including an inner wall surrounding and defining a primary fluid conduit extending through said anchor, an outer wall outboard from an exterior of said inner wall, and at least one void between said inner wall and said outer wall, said void adapted to be filled with fixation media; the deployment method including the steps of: 
 collapsing the anchor onto a catheter;    advancing the catheter from a lumen insertion point to an implantation site for the anchor;    expanding the inner wall and the outer wall of the anchor away from the catheter to a desired position for the inner wall; and    filling the void between the inner wall and the outer wall with fixation media.    
     
     
         60 - The deployment method of  claim 59  including the further step of supporting the inner wall adjacent an inboard surface of the inner wall during said filling step, such that a position of the inner wall is not deflected inward during said filling step.  
     
     
         61 - The deploying method of  claim 60  wherein said supporting step includes the step of positioning a lumen shaper balloon inboard of the inner wall of the anchor during said filling step.  
     
     
         62 - The deploying method of  claim 61  wherein said expanding step includes the step of inflating the lumen shaper balloon inboard of the inner wall until the inner wall and the outer wall are expanded away from the catheter to the desired position for the inner wall, said lumen shaper balloon remaining inflated and adjacent the inner wall during said filling step to provide support for the inner wall.  
     
     
         63 - The deploying method of  claim 59  wherein said filling step includes the steps of: 
 delivering fixation media into the void between the inner wall and the outer wall; and  
 expanding the outer wall away from the inner wall and away from the catheter to a desired position for the outer wall.  
 
     
     
         64 - The deploying method of  claim 63  including the further step of continuing said expanding step until said outer wall contacts a wall of the lumen at the implantation site for the anchor.  
     
     
         65 - The deploying method of  claim 59  including the further step of allowing the fixation media to set from a more fluid form to a less fluid form.  
     
     
         66 - The deployment method of  claim 59  including the further step of diverting fluid flow from passage through the lumen at the implantation site to a pathway through the catheter, at least during said expanding step and said filling step, such that fluid flow through the lumen continues.  
     
     
         67 - The deployment method of  claim 59  including the further step of providing the anchor with at least one of the walls having a contour generally defining an arm surrounding and defining at least one lateral fluid conduit joining with the primary fluid conduit.  
     
     
         68 - The deployment method of  claim 67  including the further step of providing a lumen shaper balloon having a deflated lesser diameter form and an inflated greater diameter form, said inflated greater diameter form having a contour at least partially matching a contour of the anchor adjacent the lateral conduit of the anchor, such that transition of the lumen shaper balloon from the deflated form to the inflated form during said expanding step causes the arm of the anchor adjacent the lateral conduit to be expanded into a lateral lumen extending from a primary lumen in which the implantation site is located.  
     
     
         69 - The deployment method of  claim 68  including the further steps of: 
 positioning a radially expandable stent on the arm surrounding the lateral conduit of the anchor and expanding the radially expandable stent until said radially expandable stent assists in engaging the arm of the anchor with the lateral lumen adjacent the implantation site for the anchor.  
 
     
     
         70 - The deployment method of  claim 59  including the further step of coupling a graft to the anchor, the graft having a tubular form surrounding the primary fluid conduit and extending the primary fluid conduit beyond the anchor.  
     
     
         71 - The deployment method of  claim 70  wherein said coupling step precedes said collapsing step, such that said graft is coupled to the anchor before implantation thereof.  
     
     
         72 - The deployment method of  claim 71  including the further step of forming the graft together with the anchor before said collapsing step.  
     
     
         73 - The deployment method of  claim 71  including the further step of attaching the graft to the anchor before said implantation step.  
     
     
         74 - The deployment method of  claim 70  wherein said coupling step occurs after said advancing step, said coupling step including the step of attaching the graft to the anchor after the anchor has been located at the implantation site for the anchor.  
     
     
         75 - A double walled intra-luminal stent-graft, comprising in combination: 
 an inner wall surrounding and defining a primary fluid conduit extending through said stent-graft;    an outer wall outboard from an exterior of said inner wall;    at least one void between said inner wall and said outer wall, said void adapted to be filled with fixation media; and    wherein at least one interconnection is provided within said at least one void, said interconnection spanning said void between said inner wall and said outer wall.    
     
     
         76 - The double walled stent-graft of  claim 75  wherein said at least one interconnection is formed of a sufficiently inelastic material such that said interconnection controls expansion of said void when said void is filled with fixation media.  
     
     
         77 - The double walled stent-graft of  claim 76  wherein said at least one interconnection includes a plurality of quilting walls extending between said inner wall and said outer wall.  
     
     
         78 - The double walled stent-graft of  claim 76  wherein said at least one interconnection includes a plurality of quilting regions extending between said inner wall and said outer wall.  
     
     
         79 - The double walled stent-graft of  claim 75  further including an anchor having an inner anchor wall surrounding and defining the primary fluid conduit adjacent an end of the stent-graft, with the primary fluid conduit extending through said anchor; and 
 said inner anchor wall having a contour in the form of an arm surrounding and defining at least one lateral fluid conduit joining with said primary fluid conduit within said anchor.  
 
     
     
         80 - The double walled stent-graft of  claim 79  wherein said anchor includes an outer anchor wall outboard from an exterior of said inner anchor wall; and 
 at least one void between said inner anchor wall and said outer anchor wall, said anchor void adapted to be filled with fixation media.  
 
     
     
         81 - The double walled stent-graft of  claim 80  wherein said inner anchor wall is formed with said anchor wall of said stent-graft and said outer anchor wall is formed with said outer wall of said stent-graft, such that said anchor and said stent-graft form a single unit.  
     
     
         82 - The double walled stent-graft of  claim 80  further including a means to couple said anchor to said stent-graft.  
     
     
         83 - The double walled stent-graft of  claim 75  wherein said at least one connection divides said void into multiple separate chambers, said separate chambers separately fillable with the fixation media.  
     
     
         84 - The double walled stent-graft of  claim 83  wherein said multiple chambers of said void are shaped as toroids surrounding said primary fluid conduit.  
     
     
         85 - An inflatable lumen shaper balloon for expanding, positioning and supporting an anchor for an intra-luminal stent-graft during expansion thereof, the inflatable lumen shaper balloon comprising in combination: 
 an exterior wall defining a fillable bladder;    at least one arm in the exterior wall extending away from other portions of the exterior wall;    means to attach said exterior wall to an intra-luminal delivery catheter; and    means to inflate said bladder.    
     
     
         86 - The balloon of  claim 85  wherein a contour of said exterior wall is shaped to at least partially match a contour of an inner wall of a double walled anchor.  
     
     
         87 - The balloon of  claim 86  wherein the double walled anchor includes at least one arm extending away from a primary fluid conduit passing through the anchor, said balloon including a balloon arm sized and positioned to be located within the arm of the anchor.  
     
     
         88 - The balloon of  claim 87  wherein said balloon arm is longer than the anchor arm, such that said balloon arm extends at least partially out of the anchor arm.  
     
     
         89 - The balloon of  claim 88  wherein said balloon arm has a position and location which correspond with a lumen anatomy of a particular patient.  
     
     
         90 - The balloon of  claim 85  wherein a knob is included at the end of said at least one arm, said knob having a greater inflated diameter than portions of said arm adjacent said knob.  
     
     
         91 - A catheter for delivery of a stent-graft intra-luminally, comprising in combination: 
 a guide wire;    a central conduit extending along a stent-graft delivery portion of said catheter, said central conduit including a bypass inlet at a first end of said central conduit closer to said guide wire and a bypass outlet located at a side of said central conduit further from said guide wire than said bypass inlet;    a balloon inflation fluid pathway passing through an interior of said catheter to a balloon inflation fluid port in said stent-graft delivery portion of said catheter; and    a fixation media delivery pathway extending through said catheter to a media delivery port adjacent said stent-graft delivery portion of said catheter.    
     
     
         92 - The catheter of  claim 91  further including a seal balloon between said bypass inlet and said bypass outlet, said seal balloon adapted to be expanded to substantially occlude a lumen in which the catheter is located, such that fluid can primarily only pass through the lumen by passing through said central conduit through said bypass inlet and said bypass outlet.  
     
     
         93 - The catheter of  claim 91  wherein said catheter is formed entirely of material which is sufficiently flexible to allow said catheter to pass intra-luminally from a femeral artery of a human patient, up to an aorta of the human patient.  
     
     
         94 - The catheter of  claim 91  wherein at least a portion of said catheter is formed of a radiopaque material.  
     
     
         95 - The catheter of  claim 94  wherein said catheter includes radiopaque material selectively located at positions axially and radially spaced from each other upon said catheter, such that a position and orientation of said catheter can be determined when said catheter is viewed through a fluoroscope or other radiopacity sensitive imaging device.  
     
     
         96 - The catheter of  claim 95  further including a sheath adapted to be removably placed over a stent-graft delivery portion of said catheter, said sheath having a diameter at least as great as a diameter of said stent-graft support region of said catheter plus a thickness of a collapsed lumen shaper balloon and a collapsed stent-graft upon said catheter.  
     
     
         97 - The catheter of  claim 91  wherein said fixation media delivery pathway is in the form of a tube.