Method for Operating a Stent Graft Delivery System Handle

A method for delivering a stent graft, which comprises:

• providing a multi-lumen stent-graft-delivery catheter with:
• an outer sheath;
• a set of interior lumens including an inner sheath;
• and
• a handle assembly connected to the outer sheath and to the set of interior lumens to at least selectively move a portion of the inner sheath with respect to the outer sheath;
• temporarily retaining a stent graft within the inner sheath inside the outer sheath;
• moving, with the handle assembly, the outer sheath and at least the inner sheath towards an implantation site to place the stent graft at a first position prior to reaching the implantation site;
• activating the handle assembly to extend at least the inner sheath distally out from the outer sheath towards the implantation site to thereby place the stent graft at a second position substantially within the implantation site while the outer sheath remains substantially at the first position;
• and
• activating the handle assembly to proximally retract the inner sheath to at least partially deploy the stent graft at the implantation site.

A method for delivering a stent graft, which comprises:

• providing a multi-lumen stent-graft-delivery catheter with:
• an outer sheath;
• and
• an inner sheath movably disposed within the outer sheath between:
• a retracted position in which, when a stent graft is disposed within the inner sheath, both the stent graft and a portion of the inner sheath holding the stent graft are disposed within the outer sheath;
• and
• an extended position in which, when the stent graft is disposed within the inner sheath, the portion of the inner sheath holding the stent graft is disposed distally outside the outer sheath;
• connecting the delivery catheter to a multi-lumen handle assembly operable to move the inner sheath between the retracted and extended positions;
• loading the stent graft within the inner sheath and moving the inner sheath into the retracted position with the handle assembly;
• moving the outer and inner sheaths with the handle assembly towards an implantation site to place the stent graft at a first distal position prior to reaching the implantation site;
• activating the handle assembly to extend at least the inner sheath distally out from the outer sheath towards the implantation site to thereby place the stent graft at a second distal position substantially within the implantation site while the outer sheath remains substantially at the first distal position;
• activating the handle assembly to proximally retract the inner sheath to at least partially deploy the stent graft at the implantation site.

A delivery system for delivering and deploying stent grafts having a proximal bare stent, comprising:

• a hollow first lumen having a distal end and an interior extending along a longitudinal axis;
• a hollow second lumen having a distal end and being slidably disposed about said first lumen;
• an apex capture device including:
• a distal capture portion fixedly connected to said distal end of said first lumen;
• and
• a proximal capture portion fixedly connected to said distal end of said second lumen, said proximal and distal capture portions being shaped to hold proximal apices of a bare stent therebetween;
• a relatively rigid, hollow outer catheter having a distal end and a first inner diameter;
• a hollow third lumen having a distal end and being slidably disposed about said second lumen and slidably disposed in said outer catheter;
• a relatively flexible, hollow stent graft sheath having a proximal end connected to said distal end of said third lumen and disposed about said second lumen, said sheath having a distal end and a second inner diameter greater than said first inner diameter to fit therein an at least partially compressed stent graft;
• and
• a distal nose having a proximal end connected to at least one of said distal capture portion and said distal end of said first lumen, said nose and said distal capture portion defining a cavity in which said distal end of said stent sheath is held releasably.

A prosthesis implantation system, comprising:

• an implantable prosthesis;
• and
• a prosthesis delivery device having:
• a handle assembly having:
• a handle body defining a longitudinal axis;
• a lumen control assembly at said handle body;
• and
• a rotating handle axially fixedly connected to said handle body with respect to said longitudinal axis and rotatably freely connected to said handle body about said longitudinal axis;
• an inner lumen operatively connected to said lumen control assembly and having a distal end and a guidewire tip at said distal end;
• an intermediate lumen disposed about said inner lumen, operatively connected to said lumen control assembly, and having a distal end;
• a relatively flexible hollow prosthesis sheath at said distal end of said intermediate lumen, said sheath being disposed about said inner lumen and shaped to at least temporarily hold therein said prosthesis for implantation at an implantation site;
• a relatively stiff outer lumen disposed about said inner lumen and said intermediate lumen and rotationally fixedly connected to said rotating handle;
• and
• said lumen control assembly operable to rotatably couple said inner and intermediate lumens to said handle body and cause rotation of said inner lumen, said intermediate lumen, and said sheath about said longitudinal axis with respect to said outer lumen when either one of:
• said rotating handle is held rotationally still and said handle body is rotated about said longitudinal axis;
• and
• said handle body is held rotationally still and said rotating handle is rotated about said longitudinal axis.

A delivery system for delivering and deploying stent grafts having a proximal bare stent, comprising:

• a hollow first lumen having a distal end and an interior extending along a longitudinal axis;
• a hollow second lumen having a distal end and being slidably disposed about said first lumen;
• a hollow graft push lumen having a distal end with an end opening and being slidably disposed about said second lumen;
• an apex capture device including:
• a distal capture portion fixedly connected to said distal end of said first lumen;
• and
• a proximal capture portion fixedly connected to said distal end of said second lumen, said proximal and distal capture portions being shaped to hold proximal apices of a bare stent therebetween;
• a relatively rigid, hollow outer catheter having a distal end and a first inner diameter;
• a hollow third lumen having a distal end and being slidably disposed about said second lumen and slidably disposed in said outer catheter;
• a buttress fixedly connected in said end opening at said distal end of said graft push lumen, said buttress having:
• a body portion having a distal end and a given outer diameter and defining a central cavity in which said second lumen is disposed slidably;
• and
• a hollow extension tube:
• extending distally from said distal end of said body portion and continuing said central cavity of said body portion;
• and
• having an outer diameter smaller than said given outer diameter;
• and
• a relatively flexible, hollow stent graft sheath having a proximal end connected to said distal end of said third lumen and disposed about said second lumen, said sheath having a distal end and a second inner diameter greater than said first inner diameter to fit therein an at least partially compressed stent graft.