Balloon assisted endoluminal prosthesis deployment

Abstract

Delivery system embodiments for treatment of a vascular defect of a patient's vasculature that may include an endoluminal prosthesis loaded on a delivery catheter. In some cases, an inflatable balloon used to facilitate deployment of the endoluminal prosthesis may be disposed within an inner lumen of a tubular graft portion of the endoluminal prosthesis.

What is claimed is: 
     
         1 . A delivery system for treatment of a vascular defect, comprising:
 an endoluminal prosthesis for treatment of the vascular defect including:   a tubular main graft portion including a thin flexible material, a main inner lumen, a proximal end and a distal end, and   a delivery catheter, comprising:   an elongate shaft including a distal section and a proximal section, the proximal section being configured to releasably secure the endoluminal prosthesis in a constrained state, and   an inflatable balloon secured to the elongate shaft and disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis in an axial position wherein a proximal end of an inflatable section of the inflatable balloon is disposed adjacent but distal of the proximal end of the tubular main graft,   wherein the elongate shaft comprises an elongate multi-lumen member extending from a distal section of the elongate shaft to a proximal section of the elongate shaft, the multi-lumen member comprising an inflation lumen for inflation of the inflatable balloon.   
     
     
         2 . The system of  claim 1 , wherein the endoluminal prosthesis comprises a self-expanding anchor member with a distal end thereof being secured to the proximal end of the tubular main graft portion. 
     
     
         3 . The system of  claim 2 , wherein a proximal end of an inflatable section of the inflatable balloon is disposed adjacent but distal of the self-expanding anchor member. 
     
     
         4 . The system of  claim 2 , wherein the multi-lumen member comprises a guidewire lumen. 
     
     
         5 . The system of  claim 4 , wherein the multi-lumen member comprises a release member lumen. 
     
     
         6 . The delivery system of  claim 1 , wherein the endoluminal prosthesis further comprises a plurality of radiopaque markers which are circumferentially disposed adjacent the proximal end of the tubular main graft portion and a proximal end of the inflatable section of the inflatable balloon is disposed adjacent but distal of the radiopaque markers. 
     
     
         7 . The delivery system of  claim 1  wherein a proximal portion of the main graft portion of the endoluminal prosthesis comprises an inflatable cuff and the inflatable balloon is axially disposed such that a working length of the inflatable balloon is axially coextensive with the inflatable cuff. 
     
     
         8 . The delivery system of  claim 1  wherein the delivery catheter further comprises an outer sheath disposed over the elongate shaft and configured to removably cover the endoluminal prosthesis in the constrained state. 
     
     
         9 . The delivery system of  claim 1  wherein the endoluminal prosthesis comprises an inflatable portion and wherein the delivery catheter further comprises a fill tube including a fill tube lumen in fluid communication with the inflatable portion of the inflatable endoluminal prosthesis and extending axially within the elongate shaft. 
     
     
         10 . The delivery system of  claim 2  wherein the self-expanding anchor member comprises a monolithic structure formed from a single piece of continuous material with no joints formed therein. 
     
     
         11 . The delivery system of  claim 2  wherein the self-expanding anchor member comprises barbs including sharp tissue penetrating tips. 
     
     
         12 . A method of deploying an endoluminal prosthesis comprising:
 advancing a delivery system into a patient's vasculature which includes an elongate shaft, an endoluminal prosthesis and an inflatable balloon,   wherein the endoluminal prosthesis comprises:
 a tubular main graft portion including a thin flexible material, a main inner lumen, a proximal end and a distal end, 
   wherein the elongate shaft comprises:
 a distal section and a proximal section, the proximal section being configured to releasably secure the endoluminal prosthesis in a constrained state, and 
 an elongate multi-lumen member extending from a distal section of the elongate shaft to a proximal section of the elongate shaft, the multi-lumen member comprising an inflation lumen for inflation of the inflatable balloon, and 
   wherein the inflatable balloon is secured to the elongate shaft and disposed within the main inner lumen of the tubular main graft portion of the endoluminal prosthesis in an axial position such that a proximal end of an inflatable section of the inflatable balloon is disposed adjacent but distal of the proximal end of the tubular main graft.   
     
     
         13 . The method of  claim 12 , wherein the endoluminal prosthesis comprises a self-expanding anchor member with a distal end thereof being secured to the proximal end of the tubular main graft portion. 
     
     
         14 . The method of  claim 13 , further comprising the step of removing a constraint to allow the self-expanding anchor member to partially deploy. 
     
     
         15 . The method of  claim 14  comprising releasing a first distal releasable belt and a second distal releasable belt to allow the self-expanding anchor member to partially deploy. 
     
     
         16 . The method of  claim 14 , further comprising the step of inflating and radially expanding the inflatable balloon so as to radially expand a portion of a graft portion of the endoluminal prosthesis which is disposed adjacent and axially coextensive with the inflatable balloon. 
     
     
         17 . The method of  claim 16 , further comprising the step of fully releasing an outer radial constraint on the self-expanding anchor member so as to fully deploying the self-expanding anchor member of the endoluminal prosthesis. 
     
     
         18 . The method of  claim 16 , comprising inflating and radially expanding the inflatable balloon so as to apply an outward radial force onto an inner surface of a main inner lumen of the main graft portion of the endoluminal prosthesis until an outer surface of the main graft portion adjacent the inflatable balloon is urged into close proximity or contact with an inner surface of the patient's vasculature. 
     
     
         19 . The method of  claim 18 , wherein the outer surface portion urged into proximity or contact with the patient's vasculature is an inflatable cuff. 
     
     
         20 . The method of  claim 19 , comprising at least partially filling the inflatable cuff with inflation material prior to urging the outer surface portion into proximity or contact with the patient's vasculature.