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

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.

A delivery system for release of a prosthesis having anchoring stents, comprising:

• a pair of releasing balloon catheters each having:
• an inflatable balloon adapted to be inserted within a corresponding stent of the prosthesis and to continue adhering thereto throughout a time prior to release thereof;
• a self-supporting tube defining a single 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, fluidically connecting said lumen with said inflatable balloon, and connecting said inflatable balloon to said tube for passing 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 for fluidically connecting a respective one of said syringes to said inflatable balloon to inflate said inflatable balloon and thereby release a respective stent;
• 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 and being fitted with a haemostatic valve;
• a median portion having a substantially constant outer fifth diameter smaller than said outer fourth diameter;
• and
• an elongated distal portion tapering for retrieval in an aorta;
• 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 running eccentrically outside 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 fitted with valves for each of said guiding catheters.

A delivery system for releasing a prosthesis having anchoring stents, 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.

A delivery system for releasing a prosthesis having anchoring stents, 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.

A method for releasing an aortic prosthesis, which comprises:

• positioning an introducer in femoral arteries of a patient;
• providing guiding balloon catheters with depth graduations and balloons;
• positioning the guiding catheters through the introducers to locate the balloons in terminal parts of common iliac arteries;
• clamping the proximal aorta, inflating the balloons of the guiding catheters, and opening the aorta for access from outside the vessel;
• threading distal ends of releasing balloon catheters through the guiding catheters and recovering the distal ends of the release catheters outside the patient;
• connecting distal ends of releasing catheters to distal portions of the prosthesis;
• moving the prosthesis until distal portions of the releasing catheters contact the guiding catheters;
• suturing a proximal part of the prosthesis to the aorta;
• inflating the balloons of the releasing catheters to fix the distal portions of the prosthesis;
• deflating the balloons of the releasing catheters and removing the releasing catheters;
• deflating the balloons of the guiding catheters and removing the guiding catheters;
• suturing the aorta;
• and
• removing the introducers.

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.

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.

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.

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.

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.

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.