Apparatus and method of placement of a graft or graft system

Abstract

A fenestrated graft deployment system, with a delivery catheter having a catheter body, An endoluminal prosthesis having a main graft body, the main graft body having a lumen therethrough and a first opening laterally through a wall of the main graft body. A first guidewire prepositioned within the delivery catheter extending through at least a portion of the catheter body into a main lumen of the endoluminal prosthesis and through the first opening in the wall of the prosthesis when the delivery catheter is in a predeployed configuration. A first fenestration alignment device is configured to extend through at least a portion of the delivery catheter and is configured to be axially moveable relative to the first guidewire. The first fenestration alignment device has an end portion having an outside perimeter configured such that when an end portion of the fenestration alignment device moves toward the first opening of said main graft body the outside perimeter of the first opening is smaller than the outside perimeter of the first fenestration alignment device and prevents it from passing through the first opening and causes the main graft body adjacent to the first opening to move with the end of the first fenestration alignment device to act as alignment tool to allow an operator to align the first opening in the side of the endoluminal prosthesis with an ostium of a target branch vessel into which said first opening is to extend and act as a guide and seal for a subsequently delivered branch graft endoluminal prosthesis.

1 . A fenestrated graft deployment system, comprising:
 a delivery catheter comprising a catheter body;   an endoluminal prosthesis having a main graft body, the main graft body having lumen therethrough and a first opening laterally through a wall of the main graft body;   a first guidewire prepositioned within the delivery catheter extending through at least a portion of the catheter body into a main lumen of the endoluminal prosthesis and through the first opening in the wall of the prosthesis when the delivery catheter is in a predeployment state; and   a first fenestration alignment device extending through at least a portion of the delivery catheter configured to be axially moveable relative to the first guidewire between a first position and a second position;   wherein:
 the first fenestration alignment device is independently moveable relative to the first guidewire between at least the first and the second positions; and 
 at least a portion of the first fenestration alignment device is larger than the first opening in at least one direction such that a portion of the fenestration alignment device engages the main graft body adjacent to the first opening when the first fenestration alignment device is advanced toward the second position. 
   
     
     
         2 . The fenestrated graft system of  claim 1 , wherein the first fenestration alignment device is configured to approximately align the first opening with an ostium of a first target branch vessel when the first fenestration alignment device is advanced to the second position. 
     
     
         3 . The fenestrated graft system of  claim 1 , wherein at least a portion of the fenestration alignment device is configured to slide over an outside surface of the first guidewire. 
     
     
         4 . The fenestrated graft system of  claim 1 , wherein a distal end portion of the first fenestration alignment device has a wall portion that surrounds at least a portion of the guidewire. 
     
     
         5 . The fenestrated graft system of  claim 1 , wherein the first guidewire prepositioned through the opening is a hollow guidewire or hollow sheath. 
     
     
         6 . The fenestrated graft system of  claim 1 , wherein a distal end portion of the first fenestration alignment device comprises a coiled component that is flexible enough to bend when being advanced over the first guidewire. 
     
     
         7 . The fenestrated graft system of  claim 1 , wherein the first fenestration alignment device comprises a tubular shaped member and a protrusion projecting from an outside surface of a distal portion of the tubular shaped member, the protrusion being sized and configured to engage the main graft body adjacent to the first opening when the first fenestration alignment device is advanced toward the second position. 
     
     
         8 . The fenestrated graft system of  claim 1 , further comprising a first branch stent configured to be deployed at least partially within the first opening after the first opening has been approximately aligned with the ostium of the first target vessel. 
     
     
         9 . The fenestrated graft system of  claim 1 , comprising a second guidewire and a second fenestration alignment device. 
     
     
         10 . A fenestration push device for use in a fenestrated prostheses deployment catheter, comprising:
 a body portion defining a lumen therethrough, the lumen having a first diameter or cross-sectional size; and   a protrusion supported at or adjacent to a distal end of the body portion, the protrusion projecting away from an outside surface of the body portion and defining a second cross-sectional size;   wherein:
 the second cross-sectional size of the fenestration push device at the location of the protrusion is greater than the first diameter or size of the body portion; and 
 the second cross-sectional size of the protrusion is greater than a cross-sectional size of a fenestration formed in a fenestrated graft that the fenestration push device will be used with. 
   
     
     
         11 . A delivery catheter comprising the fenestration push device of  claim 10  and a fenestrated prosthesis. 
     
     
         12 . The delivery catheter of  claim 11 , further comprising a guide sheath prepositioned in the delivery catheter such that, when the delivery catheter and the fenestrated prosthesis are in a pre-deployment state, the guide sheath is positioned through a lumen of the fenestrated prosthesis and advanced through a fenestration in the fenestrated prosthesis. 
     
     
         13 . The delivery catheter of  claim 12 , wherein the body portion is configured to axially translate over the outside surface of the guide sheath. 
     
     
         14 . The delivery catheter of  claim 11 , wherein at least a proximal portion of the fenestration push device extends proximally from a handle portion of the delivery catheter toward a user of the device so that the user can advance the fenestration push device toward a fenestration in the fenestrated prosthesis by distally advancing the proximal portion of the fenestration push device. 
     
     
         15 . The delivery catheter of  claim 14 , wherein the proximal portion of the fenestration push device comprises a wire. 
     
     
         16 . A method of deploying a fenestrated endoluminal prosthesis in a patient's vasculature, comprising:
 advancing a catheter supporting a fenestrated endoluminal prosthesis through a patient's vasculature to a target vessel location, wherein the prosthesis has a main graft body comprising a first opening through a wall thereof;   advancing a first guide sheath through the first opening and into a first branch vessel; and   advancing a first fenestration alignment device into contact with the prosthesis adjacent to the first opening through the wall of the prosthesis so as to approximately align the first opening with an ostium of the first branch vessel.   
     
     
         17 . The method of deploying an endoluminal prosthesis of  claim 16 , further comprising deploying a first branch stent at least partially within the first opening through the wall of the endoluminal prosthesis. 
     
     
         18 . The method of deploying an endoluminal prosthesis of  claim 16 , wherein advancing the first fenestration alignment device into contact with the prosthesis adjacent to the first opening through the wall of the prosthesis so as to approximately align the first opening with an ostium of the first branch vessel comprises advancing the first fenestration alignment device along the first guide sheath. 
     
     
         19 . The method of deploying an endoluminal prosthesis of  claim 16 , wherein:
 the first fenestration alignment device comprises a tubular body portion configured to surround the first guide sheath; and   advancing the first fenestration alignment device into contact with the prosthesis adjacent to the first opening through the wall of the prosthesis so as to approximately align the first opening with an ostium of the first branch vessel comprises advancing the first fenestration alignment device over an outside surface of the first guide sheath.   
     
     
         20 . The method of deploying an endoluminal prosthesis of  claim 16 , wherein the first guide sheath is pre-positioned through the first opening through the wall of the prosthesis when the prosthesis is in a pre-deployment state.