Vascular Prosthesis for the Treatment of Abdominal Aortic Aneurysms Using A Combined Laparoscopic/Open and Endovascular Technique, and Delivery System For Releasing A Prosthesis Fitted With Anchoring Stents

Abstract

A method for releasing an aortic prosthesis includes positioning an introducer in femoral arteries of a patient. Guiding balloon catheters are positioned through the introducers to locate balloons thereof in terminal parts of common iliac arteries. The proximal aorta is clamped, balloons of the guiding catheters are inflated, and the aorta is opened for outside access. Distal ends of releasing balloon catheters are threaded through the guiding catheters and are recovered outside the patient through the introducers. Distal ends of the releasing catheters are connected to distal portions of the prosthesis, which is moved by the catheters until distal portions thereof contact the guiding catheters. The proximal part of the prosthesis is sutured to the aorta. The balloons of the releasing catheters are inflated to fix the distal portions of the prosthesis. Balloons are deflated, catheters are removed, the aorta is sutured, and the introducers are removed.

1 . A bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta, comprising:
 a tubular body having:
 a lower extremity; and 
 an upper proximal extremity to be sutured to a proximal neck of the aorta; 
   a pair of tubular branches diverging from said lower extremity of said body and ending in corresponding distal portions;   said tubular body and said tubular branches being of a vascularly implantable material; and   retaining members secured to said distal portions.   
   
   
       2 . The vascular prosthesis according to  claim 1 , wherein:
 said retaining members are two stents; and   each of said stents is formed of a tubular portion of expandable metal mesh of a biocompatible material.   
   
   
       3 . The vascular prosthesis according to  claim 1 , wherein:
 said retaining members are two stents; and   each of said stents is fixed respectively within each extremity of said distal portions and is at least partly covered by said material.   
   
   
       4 . A bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta, comprising:
 a Y-shaped prosthesis body of a material implantable in vessels having:   a body portion with a lower extremity and an upper extremity to be sutured to a proximal neck of the aorta; and   a tubular branches respectively diverging away from said lower extremity and ending in corresponding distal portions; and retaining members secured to said distal portions.   
   
   
       5 . The vascular prosthesis according to  claim 4 , wherein said retaining members are expandable retaining members. 
   
   
       6 . The vascular prosthesis according to  claim 4 , wherein said retaining members are two stents. 
   
   
       7 . The vascular prosthesis according to  claim 6 , wherein each of said stents is formed of a tubular portion of expandable metal mesh of a biocompatible material. 
   
   
       8 . The vascular prosthesis according to  claim 4 , wherein each of said stents is fixed respectively within each extremity of said distal portions and is at least partly covered by said material. 
   
   
       9 . The vascular prosthesis according to  claim 6 , wherein each of said stents is fixed respectively within each extremity of said distal portions and is at least partly covered by said material. 
   
   
       10 - 32 . (canceled) 
   
   
       33 . A vascular prosthesis delivery kit, comprising:
 a pair of releasing balloon catheters each having:
 an inflatable balloon adapted to be removably inserted within a portion of the prosthesis; 
 a self-supporting tube defining a lumen and having a first diameter and two opposing ends; 
 a cup connection having a second diameter greater than said first diameter, said cup connection being disposed at a first of said ends and connecting said inflatable balloon to said tube to fluidically connect said lumen with said inflatable balloon to pass liquid to inflate said inflatable balloon; and 
 a terminal connection fluidically connected to said lumen at a second of said ends; 
   a pair of inflating syringes each having a connection for releasable attachment to said terminal connection of a respective one of said releasing catheters and, when connected thereto, fluidically connecting a respective one of said syringes to said inflatable balloon;   a pair of guiding balloon catheters each having:
 a dilator defining an inner lumen having an inner third diameter sized to pass said tube of said releasing catheter therethrough, said dilator having:
 a proximal portion having an outer fourth diameter larger than said inner third diameter; 
 a median portion having a substantially constant outer fifth diameter smaller than said outer fourth diameter; and 
 a distal portion tapering for insertion into a vessel; and 
 
 a tubular sheath having:
 distal ends; 
 an inner sixth diameter at least as great as said outer fifth diameter of said median portion of said dilator and less than said second diameter of said cup connection; 
 a second tube extending away from said sheath and terminating in a portion for connection to one of said inflating syringes; and 
 a terminal outer balloon connected to said second tube, said terminal outer balloon being disposed at one of said distal ends of said sheath; and 
 
   introducers for introducing each of said guiding catheters into a patient.   
   
   
       34 . The kit according to  claim 33 , further comprising a bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta having:
 a tubular body having:
 a lower extremity; and 
 an upper proximal extremity to be sutured to a proximal neck of the aorta; 
   a pair of tubular branches diverging from said lower extremity of said body and ending in corresponding distal portions;   said tubular body and said tubular branches being of a vascularly implantable material; and   retaining members secured to said distal portions.   
   
   
       35 . The kit according to  claim 33 , further comprising a bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta having:
 a Y-shaped prosthesis body of a material implantable in vessels having:
 a body portion with a lower extremity and an upper extremity to be sutured to a proximal neck of the aorta; and 
 a tubular branches respectively diverging away from said lower extremity and ending in corresponding distal portions; and 
   retaining members secured to said distal portions.   
   
   
       36 . A vascular prosthesis delivery kit, comprising:
 at least one releasing balloon catheter having:
 an inflatable balloon adapted to be removably inserted within a portion of the prosthesis; 
 a self-supporting tube defining a lumen and having a first diameter and two opposing ends; 
 a cup connection having a second diameter greater than said first diameter, said cup connection being disposed at a first of said ends and connecting said inflatable balloon to said tube to fluidically connect said lumen with said inflatable balloon to pass liquid to inflate said inflatable balloon; and 
 a terminal connection fluidically connected to said lumen at a second of said ends; 
   at least one inflating syringe having a connection for releasable attachment to said terminal connection of said releasing catheter and, when connected thereto, fluidically connecting said syringe to said inflatable balloon;   at least one guiding balloon catheter having:
 a dilator defining an inner lumen having an inner third diameter sized to pass said tube of said release catheter therethrough, said dilator having:
 a proximal portion having an outer fourth diameter larger than said inner third diameter; 
 a median portion having a substantially constant outer fifth diameter smaller than said outer fourth diameter; and 
 a distal portion tapering for insertion into a vessel; and 
 
 a tubular sheath having:
 distal ends; 
 an inner sixth diameter at least as great as said outer fifth diameter of said median portion of said dilator and less than said second diameter of said cup connection; 
 a second tube extending away from said sheath and terminating in a portion for connection to said syringe; and 
 a terminal outer balloon connected to said second tube, said terminal outer balloon being disposed at one of said distal ends of said sheath; and 
 
   at least one introducer for introducing said balloon guiding catheter into a patient.   
   
   
       37 . The kit according to  claim 36 , further comprising a bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta having:
 a tubular body having:
 a lower extremity; and 
 an upper proximal extremity to be sutured to a proximal neck of the aorta; 
   a pair of tubular branches diverging from said lower extremity of said body and ending in corresponding distal portions;   said tubular body and said tubular branches being of a vascularly implantable material; and   retaining members secured to said distal portions.   
   
   
       38 . The kit according to  claim 36 , further comprising a bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta having:
 a Y-shaped prosthesis body of a material implantable in vessels having:
 a body portion with a lower extremity and an upper extremity to be sutured to a proximal neck of the aorta; and 
 a tubular branches respectively diverging away from said lower extremity and ending in corresponding distal portions; and 
   retaining members secured to said distal portions.   
   
   
       39 . A vascular prosthesis delivery kit, comprising:
 a bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta having:
 a tubular body having:
 a lower extremity; and 
 an upper proximal extremity to be sutured to a proximal neck of the aorta; 
 
 a pair of tubular branches diverging from said lower extremity of said body and ending in corresponding distal portions; 
 said tubular body and said tubular branches being of a vascularly implantable material; and 
 retaining members secured to said distal portions; 
   a pair of releasing balloon catheters each having:
 an inflatable balloon adapted to be removably inserted within said retaining members of said prosthesis; 
 a self-supporting tube defining a lumen and having a first diameter and two opposing ends; 
 a cup connection having a second diameter greater than said first diameter, said cup connection being disposed at a first of said ends and connecting said inflatable balloon to said tube to fluidically connect said lumen with said inflatable balloon to pass liquid to inflate said inflatable balloon; and 
 a terminal connection fluidically connected to said lumen at a second of said ends; 
   a pair of inflating syringes each having a connection for releasable attachment to said terminal connection of a respective one of said releasing catheters and, when connected thereto, fluidically connecting a respective one of said syringes to said inflatable balloon;   a pair of guiding balloon catheters each having:
 a dilator defining an inner lumen having an inner third diameter sized to pass said tube of said releasing catheter therethrough, said dilator having:
 a proximal portion having an outer fourth diameter larger than said inner third diameter; 
 a median portion having a substantially constant outer fifth diameter smaller than said outer fourth diameter; and 
 a distal portion tapering for insertion into a vessel; and 
 
 a tubular sheath having:
 distal ends; 
 an inner sixth diameter at least as great as said outer fifth diameter of said median portion of said dilator and less than said second diameter of said cup connection; 
 a second tube extending away from said sheath and terminating in a portion for connection to one of said inflating syringes; and 
 a terminal outer balloon connected to said second tube, said terminal outer balloon being disposed at one of said distal ends of said sheath; and 
 
   introducers for introducing each of said guiding catheters into a patient.   
   
   
       40 . A vascular prosthesis delivery kit, comprising:
 a bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta having:
 a Y-shaped prosthesis body of a material implantable in vessels having:
 a body portion with a lower extremity and an upper extremity to be sutured to a proximal neck of the aorta; and 
 a tubular branches respectively diverging away from said lower extremity and ending in corresponding distal portions; and 
 
 retaining members secured to said distal portions; 
   a pair of releasing balloon catheters each having:
 an inflatable balloon adapted to be removably inserted within said retaining members of said prosthesis; 
 a self-supporting tube defining a lumen and having a first diameter and two opposing ends; 
 a cup connection having a second diameter greater than said first diameter, said cup connection being disposed at a first of said ends and connecting said inflatable balloon to said tube to fluidically connect said lumen with said inflatable balloon to pass liquid to inflate said inflatable balloon; and 
 a terminal connection fluidically connected to said lumen at a second of said ends; 
   a pair of inflating syringes each having a connection for releasable attachment to said terminal connection of a respective one of said releasing catheters and, when connected thereto, fluidically connecting a respective one of said syringes to said inflatable balloon;   a pair of guiding balloon catheters each having:
 a dilator defining an inner lumen having an inner third diameter sized to pass said tube of said releasing catheter therethrough, said dilator having:
 a proximal portion having an outer fourth diameter larger than said inner third diameter; 
 a median portion having a substantially constant outer fifth diameter smaller than said outer fourth diameter; and 
 a distal portion tapering for insertion into a vessel; and 
 
 a tubular sheath having:
 distal ends; 
 an inner sixth diameter at least as great as said outer fifth diameter of said median portion of said dilator and less than said second diameter of said cup connection; 
 a second tube extending away from said sheath and terminating in a portion for connection to one of said inflating syringes; and 
 a terminal outer balloon connected to said second tube, said terminal outer balloon being disposed at one of said distal ends of said sheath; and 
 
   introducers for introducing each of said guiding catheters into a patient.   
   
   
       41 . A vascular prosthesis delivery kit, comprising:
 a bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta having:
 a tubular body having:
 a lower extremity; and 
 an upper proximal extremity to be sutured to a proximal neck of the aorta; 
 
 a pair of tubular branches diverging from said lower extremity of said body and ending in corresponding distal portions; 
 said tubular body and said tubular branches being of a vascularly implantable material; and 
 retaining members secured to said distal portions; 
   at least one releasing balloon catheter having:
 an inflatable balloon adapted to be removably inserted within said retaining members of said prosthesis; 
 a self-supporting tube defining a lumen and having a first diameter and two opposing ends; 
 a cup connection having a second diameter greater than said first diameter, said cup connection being disposed at a first of said ends and connecting said inflatable balloon to said tube to fluidically connect said lumen with said inflatable balloon to pass liquid to inflate said inflatable balloon; and 
 a terminal connection fluidically connected to said lumen at a second of said ends; 
   at least one inflating syringe having a connection for releasable attachment to said terminal connection of said releasing catheter and, when connected thereto, fluidically connecting said syringe to said inflatable balloon;   at least one guiding balloon catheter having:
 a dilator defining an inner lumen having an inner third diameter sized to pass said tube of said release catheter therethrough, said dilator having:
 a proximal portion having an outer fourth diameter larger than said inner third diameter; 
 a median portion having a substantially constant outer fifth diameter smaller than said outer fourth diameter; and 
 a distal portion tapering for insertion into a vessel; and 
 
 a tubular sheath having: 
 distal ends; 
 an inner sixth diameter at least as great as said outer fifth diameter of said median portion of said dilator and less than said second diameter of said cup connection; 
 a second tube extending away from said sheath and terminating in a portion for connection to said syringe; and 
 a terminal outer balloon connected to said second tube, said terminal outer balloon being disposed at one of said distal ends of said sheath; and 
   at least one introducer for introducing said balloon guiding catheter into a patient.   
   
   
       42 . A vascular prosthesis delivery kit, comprising:
 a bifurcated vascular prosthesis for curing aneurysms of the abdominal aorta having:
 a Y-shaped prosthesis body of a material implantable in vessels having:
 a body portion with a lower extremity and an upper extremity to be sutured to a proximal neck of the aorta; and 
 a tubular branches respectively diverging away from said lower extremity and ending in corresponding distal portions; and 
 
 retaining members secured to said distal portions; 
   at least one releasing balloon catheter having:
 an inflatable balloon adapted to be removably inserted within said retaining members of said prosthesis; 
 a self-supporting tube defining a lumen and having a first diameter and two opposing ends; 
 a cup connection having a second diameter greater than said first diameter, said cup connection being disposed at a first of said ends and connecting said inflatable balloon to said tube to fluidically connect said lumen with said inflatable balloon to pass liquid to inflate said inflatable balloon; and 
 a terminal connection fluidically connected to said lumen at a second of said ends; 
   at least one inflating syringe having a connection for releasable attachment to said terminal connection of said releasing catheter and, when connected thereto, fluidically connecting said syringe to said inflatable balloon;   at least one guiding balloon catheter having:
 a dilator defining an inner lumen having an inner third diameter sized to pass said tube of said release catheter therethrough, said dilator having:
 a proximal portion having an outer fourth diameter larger than said inner third diameter; 
 a median portion having a substantially constant outer fifth diameter smaller than said outer fourth diameter; and 
 a distal portion tapering for insertion into a vessel; and 
 
 a tubular sheath having:
 distal ends; 
 an inner sixth diameter at least as great as said outer fifth diameter of said median portion of said dilator and less than said second diameter of said cup connection; 
 a second tube extending away from said sheath and terminating in a portion for connection to said syringe; and 
 a terminal outer balloon connected to said second tube, said terminal outer balloon being disposed at one of said distal ends of said sheath; and 
 
   at least one introducer for introducing said balloon guiding catheter into a patient.