Sheath Capture Device For Stent Graft Delivery System And Method For Operating Same

• US 20150202068A1
• Filed: 03/31/2015
• Published: 07/23/2015
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Arbefeuille, Samuel, Berra, Humberto, Ouellette, Gerry
• Granted Patent: US 9,877,857 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/95 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A delivery system for delivering and deploying stent grafts having a proximal stent includes a first lumen and a stent capture device including a capture portion fixedly connected adjacent a first lumen distal end. An outer catheter has a catheter distal end and a catheter inner diameter. A second lumen having a second distal end is slidably disposed about the first lumen and within the outer catheter. A stent graft sheath has a sheath proximal end connected to the second distal end and disposed about the first lumen. The sheath has a sheath distal end and a sheath inner diameter greater than the catheter inner diameter for holding a compressed stent graft. A distal nose cone has a cone proximal end connected to either the capture portion or the first distal end. The nose cone and the capture portion are movably adjustable to selectively capture the sheath distal end therebetween.

Claims

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

a hollow first lumen having a first distal end;

a stent capture device including a distal apex head and a proximal apex body, the distal apex head defining a distal surface and a proximal surface, and the distal apex head and the proximal apex body defining a cavity for capturing a stent between the proximal surface of the distal apex head and the proximal apex body, the distal apex head being fixedly connected to said first distal end of the hollow first lumen;

a hollow outer catheter having a catheter distal end and a catheter inner diameter;

a hollow second lumen having a second distal end and being slidably disposed about said first lumen and slidably disposed in said outer catheter;

a hollow stent graft sheath having a sheath proximal end connected to said second distal end and disposed about said first lumen, said sheath having a sheath distal end and a sheath inner diameter greater than said catheter inner diameter to fit therein an at least partially compressed stent graft and being relatively flexible compared to the hollow outer catheter; and

a distal nose cone having a cone proximal end connected to at least one of said distal apex head and said first distal end of the hollow first lumen, said nose cone and said distal surface of the distal apex head defining a cavity to selectively capture said sheath distal end therebetween, whereby the sheath can be removed while the stent remains within the cavity, and wherein said sheath distal end is releaseably secured within said cavity.

2. The delivery system according to claim 1, further comprising a handle, said outer catheter defining a longitudinal axis and being longitudinally fixedly connected to said handle about said second lumen, said first and second lumens being longitudinally movably connected to said handle.

3. The delivery system according to claim 2, wherein said outer catheter has a length only long enough to be inserted in a patient'"'"'s aorta to approximately the patient'"'"'s celiac axis.

4. The delivery system according to claim 1, further comprising a hollow third lumen disposed about said first lumen and within said second lumen, said third lumen having a third distal end, said proximal apex body being fixedly connected to said third distal end and selectively movable with respect to said distal apex head to capture a stent therebetween.

8. The method according to claim 4, which further comprises:

advancing the outer catheter in a patient towards a treatment site up to a given position at a distance from the treatment site;

while retaining the outer catheter in the given position;

advancing the stent graft sheath out from the outer catheter to the treatment site to align the stent graft with the treatment site;

releasing the sheath distal end of the sheath from between the distal surface of the distal apex head and the distal nose cone and unsheathing the stent graft from the sheath by retracting the second lumen away from the treatment site to at least partially implant the stent graft at the treatment site;

releasing the stent from between the proximal surface of the distal apex head and the proximal apex body of the stent capture device to thereby implant the stent graft at the treatment site; and

upon completion of the stent graft implantation, retracting both of the stent graft sheath and the outer catheter from the patient.

9. The method according to claim 8, which further comprises carrying out the advancing step by advancing the sheath out from the outer catheter to the treatment site to axially align the stent graft with the treatment site and rotating the stent graft sheath to circumferentially align the stent graft with the treatment site.

10. The method according to claim 8, which further comprises carrying out the advancing step by advancing the outer catheter towards the treatment site only up to a point at a distance from the treatment site greater than a length of the stent graft.

11. The method according to claim 8, which further comprises carrying out the advancing step by advancing the outer catheter in vasculature of a patient towards a vascular treatment site.

12. The method according to claim 11, which further comprises carrying out the advancing step by advancing the outer catheter in aortic vasculature of the patient to approximately a celiac axis of the patient.

15. The method according to claim 8, which further comprises carrying out the retracting step upon completion of the stent graft implantation by:

retracting the stent graft sheath into the outer catheter; and

subsequently retracting the outer catheter containing the stent graft sheath from the patient.

17. The delivery system of claim 1, wherein said nose cone and said distal apex head are movably adjustable relative to each other by a threadable connection.

5. A method of loading a stent graft in a prosthesis delivery system for implanting a stent graft in a patient at a treatment site, comprising the steps of:

providing a prosthesis delivery system including;

a hollow first lumen having a first distal end;

a stent capture device including a distal apex head and a proximal apex body, the distal apex head defining a distal surface and a proximal surface, and the distal apex head and the proximal apex body defining a cavity for capturing a stent between the proximal surface of the distal apex head and the proximal apex body, the distal apex head being fixedly connected to the first distal end of the hollow first lumen;

a hollow outer catheter having a catheter distal end and a catheter inner diameter; and

a hollow second lumen having a second distal end and being slidably disposed about said first lumen and slidably disposed in said outer catheter;

loading a stent graft inside a hollow stent graft sheath having a sheath inner diameter greater than said catheter inner diameter to temporarily dispose the stent graft therein in an at least partially compressed state, the stent graft sheath being disposed about said first lumen and having a sheath distal end and a sheath proximal end connected to said second distal end and relatively flexible compared to the hollow outer catheter;

temporarily capturing a stent of the stent graft with the stent capture device between the distal apex head and proximal apex body;

removably capturing the sheath distal end between the distal surface of the distal apex head and a distal nose cone having a proximal end connected to at least one of the distal apex head and the first distal end, the nose cone and the distal surface of the distal apex head defining a cavity, whereby the sheath can be removed while the stent remains within the cavity, and wherein the sheath distal end is releaseably secured within the cavity; and

loading the sheath with the partially compressed stent graft into the outer catheter to compress the stent graft even further for subsequent implantation at the treatment site.

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

extending the outer catheter with the loaded sheath up to a given position at a distance from the treatment site; and

implanting the stent graft at the treatment site.

7. The method according to claim 6, which further comprises carrying out the implantation step by:

extending the first and second lumens in a patient towards the treatment site to move the sheath out from the outer catheter and return the stent graft to the partially compressed state in the sheath;

extending the first and second lumens further towards the treatment site to place the loaded sheath at the treatment site; and

releasing the sheath distal end from between the distal surface of the distal apex head and the distal nose cone and unsheathing the stent graft from the sheath by retracting the second lumen away from the treatment site; and

releasing the stent from between the proximal surface of the distal apex head and the proximal apex body of the stent capture device to thereby implant the stent graft at the treatment site.

13. The method according to claim 5, which further comprises providing the outer catheter with a length sufficient to reach to approximately a celiac axis of a patient.

14. The method according to claim 5, which further comprises providing the outer catheter with a length equal to approximately a distance from the patient'"'"'s femoral arterial access site to the patient'"'"'s celiac axis.

16. The method according to claim 5, which further comprises providing the stent graft sheath of a material relatively more flexible than a material of the outer catheter.