Introducer for deployment of branched prosthesis

Claim 1

An introducer for insertion in a lumen from a proximal location outside the lumen to a distal location within the lumen for deployment of a prosthesis at a junction of a main lumen and at least one branch lumen, the introducer comprising: an outer sheath having a distal end; an axial guide wire slidable within the outer sheath; at least one peripheral guide wire slidable within the outer sheath, the peripheral guide wire comprising an expandable balloon at a distal end thereof; and a nose cone located at the distal end of the outer sheath, the nose cone having a periphery, an axial conduit slidable over the axial guide wire, and at least one peripheral channel spaced apart from the axial conduit for receiving one of the peripheral guide wires.

Claim 14

A method for implanting a prosthesis in a distal location within a lumen from a proximal location outside the lumen, the distal location positioned at a junction of a main lumen and at least one branch lumen, the prosthesis comprising at least one stent and having a trunk and at least one arm, each arm for implantation into the branch lumen and the trunk for implantation into the main lumen, the method comprising the steps of: (a) providing an introducer comprising an outer sheath; an axial guide wire and at least one peripheral guide wire slidable within the outer sheath; a nose cone at a distal end of the outer sheath, the nose cone having an axial conduit slidable over the axial guide wire and at least one peripheral guide channel each for receiving one of the peripheral guide wires, each peripheral guide wire comprising an inflatable anchor balloon at a distal end thereof; a trunk deployment catheter concentric with the axial guidewire and having at least one inflatable deployment balloon; and at least one arm deployment catheter concentric with the peripheral guide wire and having at least one inflatable deployment balloon; (b) providing the prosthesis inside the outer sheath with the trunk mounted over the axial guide wire and at least one trunk stent portion mounted over each inflatable deployment balloon of the trunk deployment catheter and each arm mounted over one of the peripheral guide wires and at least one arm stent portion mounted over each inflatable deployment balloon of each arm deployment catheter; (c) introducing the introducer into the lumen until reaching an implantation position adjacent the branch lumen; (d) maintaining the introducer in the implantation position while advancing each peripheral guide wire distally through one of the peripheral channels of the nose cone until each wire is positioned at a sufficient depth within the corresponding branch lumen; (e) inflating each anchor balloon on each peripheral guide wire to fix the wire in a set position; (f) advancing the prosthesis over the axial and peripheral guide wires until each arm of the prosthesis is positioned at a sufficient depth within the branch lumen, and (g) inflating the deployment balloons to expand at least the trunk and arm stent portions of the prosthesis to implant the prosthesis.

Claim 15

A method for implanting a prosthesis in a distal location within a lumen from a proximal location outside the lumen, the distal location positioned at a junction of a main lumen and at least one branch lumen, the prosthesis comprising at least one stent and having a trunk and at least one arm, each arm for implantation into the branch lumen and the trunk for implantation into the main lumen, the method comprising the steps of: (a) providing an introducer comprising an outer sheath; an axial guide wire and at least one peripheral guide wire slidable within the outer sheath; a nose cone at a distal end of the outer sheath, the nose cone having an axial conduit slidable over the axial guide wire and at least one peripheral guide channel each for receiving one of the peripheral guide wires, each peripheral guide wire comprising an inflatable anchor balloon at a distal end thereof; a trunk deployment catheter concentric with the axial guidewire and having at least one inflatable deployment balloon; and at least one arm deployment catheter concentric with the peripheral guide wire and having at least one inflatable deployment balloon; (b) providing the prosthesis inside the outer sheath with the trunk mounted over the axial guide wire and at least one trunk stent portion mounted over each inflatable deployment balloon of the trunk deployment catheter and each arm mounted over one of the peripheral guide wires and at least one arm stent portion mounted over each inflatable deployment balloon of each arm deployment catheter; (c) introducing the introducer into the lumen until reaching an implantation position adjacent the branch lumen; (d) maintaining the introducer in the implantation position while advancing each peripheral guide wire distally through one of the peripheral channels of the nose cone until each wire is positioned at a sufficient depth within the corresponding branch lumen; (e) inflating each anchor balloon on each peripheral guide wire to fix the wire in a set position; (f) advancing the prosthesis over the axial and peripheral guide wires until each arm of the prosthesis is positioned at a sufficient depth within the branch lumen, and (g) inflating the deployment balloons to expand at least the trunk and arm stent portions of the prosthesis to implant the prosthesis.

Claim 22

A method for implanting a modular prosthesis in a distal location within a lumen from a proximal location outside the lumen, the distal location positioned at a junction of a main lumen and at least one branch lumen, the modular prosthesis comprising a trunk module for implantation into the main lumen and comprising at least one stent and at least one arm fitting, the modular prosthesis further comprising at least one arm module for implantation into the branch lumen, the arm module adapted to interconnect with the arm fitting of the trunk module and comprising at least one stent, the method comprising the steps of: (a) positioning a first introducer in the main lumen in a first implantation position adjacent the branch lumen, the first introducer comprising an outer sheath; an axial guide wire slidable within the outer sheath; a nose cone at a distal end of the outer sheath, the nose cone having an axial conduit slidable over the axial guide wire; a trunk deployment catheter concentric with the axial guidewire and having at least one inflatable deployment balloon; the modular prosthesis inside the outer sheath with the trunk module mounted over the axial guide wire and at least one trunk stent portion mounted over each inflatable deployment balloon of the trunk deployment catheter (b) advancing the nose cone distally to a location distal of the junction of the main lumen with the branch lumen; (c) implanting the trunk module with each arm fitting aligned with a corresponding branch lumen by inflating the trunk section deployment balloons to expand the trunk stent portions; (d) positioning a second introducer in the main lumen in a second implantation position, the second introducer comprising an outer sheath; an axial guide wire and at least one peripheral guide wire slidable within the outer sheath; a nose cone at a distal end of the outer sheath, the nose cone having an axial conduit slidable over the axial guide wire and at least one peripheral guide channel each for receiving one of the peripheral guide wires, each peripheral wire comprising an inflatable anchor balloon at a distal end thereof; a trunk deployment catheter concentric with the axial guidewire and having at least one inflatable deployment balloon; at least one arm deployment catheter concentric with the peripheral guide wire and having at least one inflatable deployment balloon; each arm module mounted over one of the peripheral guide wires and at least one arm stent portion of each arm module mounted over each inflatable deployment balloon of each arm deployment catheter; (e) maintaining the second introducer in the implantation position while advancing each peripheral guide wire distally through one of the peripheral channels of the nose cone and through one of the arm fittings in the implanted trunk module until each peripheral guide wire is positioned at a sufficient depth within the corresponding branch lumen; (f) inflating each anchor balloon on each peripheral guide wire to fix the wire in a set position; (g) advancing each arm module over one of the peripheral guide wires until each arm module is positioned at a sufficient depth within the branch lumen and in an interlocking position with one of the arm fittings of the trunk module; (h) inflating each arm deployment balloon to expand at least the arm stent portions of each arm module to implant the arm module within the branch lumen and within the corresponding arm fitting of trunk module.

Claim 23

A method for implanting a modular prosthesis in a distal location within a lumen from a proximal location outside the lumen, the distal location positioned at a junction of a main lumen and at least one branch lumen, the modular prosthesis comprising a trunk module for implantation into the main lumen and comprising at least one stent and at least one arm fitting, the modular prosthesis further comprising at least one arm module for implantation into the branch lumen, the arm module adapted to interconnect with the arm fitting of the trunk module and comprising at least one stent, the method comprising the steps of: (a) positioning a first introducer in the main lumen in a first implantation position adjacent the branch lumen, the first introducer comprising an outer sheath; an axial guide wire slidable within the outer sheath; a nose cone at a distal end of the outer sheath, the nose cone having an axial conduit slidable over the axial guide wire; a trunk deployment catheter concentric with the axial guidewire and having at least one inflatable deployment balloon; the modular prosthesis inside the outer sheath with the trunk module mounted over the axial guide wire and at least one trunk stent portion mounted over each inflatable deployment balloon of the trunk deployment catheter (b) advancing the nose cone distally to a location distal of the junction of the main lumen with the branch lumen; (c) implanting the trunk module with each arm fitting aligned with a corresponding branch lumen by inflating the trunk section deployment balloons to expand the trunk stent portions; (d) positioning a second introducer in the main lumen in a second implantation position, the second introducer comprising an outer sheath; an axial guide wire and at least one peripheral guide wire slidable within the outer sheath; a nose cone at a distal end of the outer sheath, the nose cone having an axial conduit slidable over the axial guide wire and at least one peripheral guide channel each for receiving one of the peripheral guide wires, each peripheral wire comprising an inflatable anchor balloon at a distal end thereof; a trunk deployment catheter concentric with the axial guidewire and having at least one inflatable deployment balloon; at least one arm deployment catheter concentric with the peripheral guide wire and having at least one inflatable deployment balloon; each arm module mounted over one of the peripheral guide wires and at least one arm stent portion of each arm module mounted over each inflatable deployment balloon of each arm deployment catheter; (e) maintaining the second introducer in the implantation position while advancing each peripheral guide wire distally through one of the peripheral channels of the nose cone and through one of the arm fittings in the implanted trunk module until each peripheral guide wire is positioned at a sufficient depth within the corresponding branch lumen; (f) inflating each anchor balloon on each peripheral guide wire to fix the wire in a set position; (g) advancing each arm module over one of the peripheral guide wires until each arm module is positioned at a sufficient depth within the branch lumen and in an interlocking position with one of the arm fittings of the trunk module; (h) inflating each arm deployment balloon to expand at least the arm stent portions of each arm module to implant the arm module within the branch lumen and within the corresponding arm fitting of trunk module.

Claim 25

A method for implanting a prosthesis in a distal location within the lumen from a proximal location outside the lumen, the distal location positioned at a junction of a main lumen and at least one branch lumen, the prosthesis having a compressed configuration and an expanded configuration and comprising at least one portion for implantation into the branch lumen, the method comprising the steps of: (a) providing an introducer comprising an outer sheath; an axial guide wire and at least one peripheral guide wire slidable within the outer sheath; a nose cone at a distal end of the outer sheath, the nose cone having an axial conduit slidable over the axial guide wire and at least one peripheral guide channel for receiving the peripheral guide wire, the peripheral wire comprising an inflatable anchor balloon at a distal end thereof; (b) introducing the introducer into the lumen until reaching an implantation position adjacent the branch lumen; (c) maintaining the introducer in the implantation position while advancing the peripheral guide wire distally through the peripheral channel of the nose cone until the peripheral guide wire is positioned at a sufficient depth the branch lumen; (d) inflating the anchor balloon to fix the peripheral guide wire in a set position; (e) advancing the prosthesis over the peripheral guide wire until at least a portion of the prosthesis is positioned at a sufficient depth within the branch lumen, and (f) expanding at least a portion of the prosthesis to implant the portion of the prosthesis in the branch lumen.

Claim 26

A method for implanting a prosthesis in a distal location within the lumen from a proximal location outside the lumen, the distal location positioned at a junction of a main lumen and at least one branch lumen, the prosthesis having a compressed configuration and an expanded configuration and comprising at least one portion for implantation into the branch lumen, the method comprising the steps of: (a) providing an introducer comprising an outer sheath; an axial guide wire and at least one peripheral guide wire slidable within the outer sheath; a nose cone at a distal end of the outer sheath, the nose cone having an axial conduit slidable over the axial guide wire and at least one peripheral guide channel for receiving the peripheral guide wire, the peripheral wire comprising an inflatable anchor balloon at a distal end thereof; (b) introducing the introducer into the lumen until reaching an implantation position adjacent the branch lumen; (c) maintaining the introducer in the implantation position while advancing the peripheral guide wire distally through the peripheral channel of the nose cone until the peripheral guide wire is positioned at a sufficient depth the branch lumen; (d) inflating the anchor balloon to fix the peripheral guide wire in a set position; (e) advancing the prosthesis over the peripheral guide wire until at least a portion of the prosthesis is positioned at a sufficient depth within the branch lumen, and (f) expanding at least a portion of the prosthesis to implant the portion of the prosthesis in the branch lumen.