Method for Operating a Stent Graft Delivery System Handle

• US 20080077227A1
• Filed: 07/26/2007
• Published: 03/27/2008
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Barbre, Carol, Berra, Humberto, Arbefeuille, Samuel, Ouellette, Gerry
• Granted Patent: US 8,062,345 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A method for delivering a stent graft includes the steps of moving lumens retaining a stent graft within a multi-lumen stent-graft-delivery catheter towards an implantation site to place the stent graft at a first position prior to reaching the implantation site. The delivery catheter has at least one interior lumen holding the stent graft. A handle assembly of the delivery catheter is activated to extend distally the at least one interior lumen towards the implantation site to thereby place the stent graft at a second position substantially within the implantation site while a lumen surrounding the at least one interior lumen of the delivery catheter remains substantially at the first position. The handle assembly is activated to proximally retract a sheath holding the stent graft to at least partially deploy the stent graft at the implantation site.

Claims

1. A method for delivering a stent graft, which comprises:

moving lumens retaining a stent graft within a multi-lumen stent-graft-delivery catheter towards an implantation site to place the stent graft at a first position prior to reaching the implantation site, the delivery catheter having at least one interior lumen holding the stent graft;

activating a handle assembly of the delivery catheter to extend distally the at least one interior lumen towards the implantation site to thereby place the stent graft at a second position substantially within the implantation site while a lumen surrounding the at least one interior lumen of the delivery catheter remains substantially at the first position; and

activating the handle assembly to proximally retract a sheath holding the stent graft to at least partially deploy the stent graft at the implantation site.

2. The method according to claim 1, which further comprises carrying out the extend activating step by activating the handle assembly to extend distally the at least one interior lumen towards the implantation site to thereby place the stent graft at the second position while an outermost lumen of the delivery catheter remains substantially at the first position.

3. The method according to claim 1, which further comprises carrying out the extend activating step by activating the handle assembly to extend distally at least two interior lumens holding the stent graft therebetween towards the implantation site to thereby longitudinally place the stent graft at the second position while an outermost lumen of the delivery catheter remains substantially at the first position.

4. The method according to claim 1, which further comprises carrying out the retract activating step by activating the handle assembly to proximally retract a sheath holding the stent graft to at least partially deploy the stent graft at the implantation site while at least one innermost lumen of the delivery catheter remains substantially at the second position.

5. The method according to claim 1, which further comprises:

carrying out the extend activating step by activating the handle assembly to extend distally at least two interior lumens towards the implantation site to thereby place the stent graft at a second position substantially within the implantation site while a lumen surrounding the at least one interior lumen of the delivery catheter remains substantially at the first position; and

carrying out the retract activating step by activating the handle assembly to proximally retract a sheath holding the stent graft to at least partially deploy the stent graft at the implantation site while at least one innermost lumen of the at least two interior lumens remains substantially at the second position.

6. The method according to claim 1, wherein the sheath holding the stent graft is a sheath of the at least one interior lumen and the lumen surrounding the at least one interior lumen is an outermost lumen, and which further comprises, prior to carrying out the moving step:

radially compressing the stent graft within the sheath;

loading the sheath containing the stent graft within the outermost lumen; and

carrying out the retract activating step by activating the handle assembly to proximally retract the sheath to at least partially deploy the stent graft at the implantation site.

7. The method according to claim 1, which further comprises:

providing the lumen surrounding the at least one interior lumen with a given inner diameter;

providing the sheath with an outer diameter greater than the given diameter;

carrying out the retract activating step by collapsing a least a portion of the sheath into the lumen surrounding the at least one interior lumen.

8. The method according to claim 1, wherein:

the lumen surrounding the at least one interior lumen is an outer sheath;

the at least one interior lumen delivery catheter includes an inner sheath movably disposed within the outer sheath between;

a retracted position in which, when the stent graft is disposed within the inner sheath, both the inner sheath and 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, a portion of the inner sheath containing the stent graft is disposed distally outside the outer sheath,

and which further comprises;

carrying out the moving step by;

placing the inner sheath in the retracted position with the stent graft loaded therewithin; and

moving both the outer and inner sheaths towards the implantation site to place the stent graft at the first position;

carrying out the extend activating step by activating the handle assembly to extend distally at least the inner sheath towards the implantation site to thereby place the stent graft at the second position substantially within the implantation site while the outer sheath remains substantially at the first position;

carrying out the retract activating step by activating the handle assembly to proximally retract the inner sheath to at least partially deploy the stent graft at the implantation site.

9. The method according to claim 8, wherein the at least one interior lumen delivery catheter includes at least one innermost lumen, and which further comprises:

carrying out the extend activating step by activating the handle assembly to extend distally at least the inner sheath and the at least one innermost lumen 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

carrying out the retract activating step by activating the handle assembly to proximally retract the inner sheath to at least partially deploy the stent graft at the implantation site while the at least one innermost lumen remains substantially at the second position.

10. The method according to claim 1, which further comprises deploying the stent graft at the implantation site and removing the delivery catheter from the implantation site.

11. The method according to claim 1, which further comprises connecting the handle assembly to lumens of the delivery catheter.

12. The method according to claim 11, which further comprises selectively connecting respective portions of the multi-lumen handle assembly to respective ones of the lumens of the delivery catheter.

13. The method according to claim 1, which further comprises carrying out the moving step within vasculature of the human body.

14. The method according to claim 13, which further comprises carrying out the moving step within an aorta.

15. 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.

16. The method according to claim 15, wherein the set of interior lumens includes at least one innermost lumen and which further comprises:

carrying out the moving step by moving, with the handle assembly, the outer sheath and the set of interior lumens towards the implantation site to place the stent graft at the first position prior to reaching the implantation site;

carrying out the extend activating step by activating the handle assembly to extend at least the inner sheath and the at least one innermost lumen towards the implantation site to thereby place the stent graft at the second position substantially within the implantation site while the outer sheath remains substantially at the first position; and

carrying out the retract activating step by activating the handle assembly to proximally retract the inner sheath to at least partially deploy the stent graft at the implantation site while the at least one innermost lumen remains substantially at the second position.

17. The method according to claim 15, which further comprises carrying out the moving step within vasculature of the human body.

18. 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.

19. The method according to claim 18, wherein the inner sheath has at least an outer lumen holding the stent graft and an inner lumen, and which further comprises:

carrying out the connecting step by connecting the delivery catheter to a multi-lumen handle assembly operable to move the inner and outer lumens between the retracted and extended positions;

carrying out the loading step by loading the stent graft between the outer and inner lumens and moving the outer and inner lumens together into the retracted position with the handle assembly;

carrying out the extend activating step by activating the handle assembly to extend at least the inner and outer lumens towards the implantation site to thereby place the stent graft at the second position substantially within the implantation site while the outer sheath remains substantially at the first position; and

carrying out the retract activating step by activating the handle assembly to proximally retract the outer lumen to at least partially deploy the stent graft at the implantation site while the inner lumen remains substantially at the second position.

20. The method according to claim 18, which further comprises carrying out the moving step within vasculature of the human body.

21. 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.

22. 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.

23. 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.