Delivery systems for delivering and deploying stent grafts

• US 8,062,345 B2
• Filed: 07/26/2007
• Issued: 11/22/2011
• 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, Ouellette, Gerry, Berra, Humberto, Arbefeuille, Samuel
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): DOWE, KATHERINE MARIE
• Application Number:
  US11/828,675
• Publication Number:
  US 20080077227A1
• Time in Patent Office: 1,580 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 606/108
• US Class Current: 623/1.12
• 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 delivery system for delivering and deploying a stent graft includes a guidewire catheter, an apex release catheter, an apex capture device, a relatively rigid, hollow catheter, a sheath catheter, a relatively flexible, hollow stent graft sheath and a distal nose. The apex capture device includes a distal capture portion fixedly connected to the distal end of the guidewire catheter and having a distal portion and a proximal stopper having an exposed side facing distally in a plane approximately perpendicular to a longitudinal axis of the guidewire catheter. The apex capture device also includes a proximal capture portion fixedly connected to the distal end of the apex release catheter and has fingers extending toward the distal capture portion in a distal direction that define an interior cavity to receive the proximal stopper. The proximal and distal capture portions of the apex capture device define a stent capture state. In an embodiment, the delivery system further includes a hollow graft push catheter slidably disposed about the apex release catheter and a connected to the distal end of the graft push catheter.

Claims

1. A delivery system for delivering and deploying a stent graft, comprising:

a) a guidewire catheter having a distal end and an interior extending along a longitudinal axis;

b) an apex release catheter having a distal end and being slidably disposed about said guidewire catheter;

c) an apex capture device including;

i) a distal capture portion fixedly connected to said distal end of said guidewire catheter, said distal capture portion having

a distal portion with a proximal end, and

a proximal stopper having an exposed side facing distally that is disposed in a place approximately perpendicular to said longitudinal axis and defining stopping surface portions, and a proximal side extending along a line that intersects with the guidewire catheter proximal to said exposed side of the proximal stopper, and

ii) a proximal capture portion fixedly connected to said distal end of said apex release catheter, and having fingers extending toward said distal capture portion in a distal direction, said fingers defining an interior cavity shaped to receive said proximal stopper therein, wherein

said proximal and distal capture portions are formed to hold proximal apices joining struts of a stent therebetween and, together, define a stent captured state in which said proximal stopper and proximal apices of the stent are received in said interior cavity to thereby constrain the proximal apices while the struts emanate radially from between the fingers of the proximal capture portion, and said distal capture portion approximately closes off said interior cavity along said longitudinal axis;

d) a relatively rigid, hollow outer catheter having a distal end and a first inner diameter;

e) a sheath catheter having a distal end and being slidably disposed about said apex release catheter and slidably disposed in said outer catheter;

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

g) a distal nose having a proximal end connected to at least one of said distal capture portion and said distal end of said guidewire catheter, said nose and said distal capture portion defining a cavity in which said distal end of said stent graft sheath is held releasably.

2. The delivery system of claim 1, further including said stent graft about said apex release catheter and within said hollow stent graft sheath, said stent graft being releasably fixed at said apex capture device.

3. The delivery system of claim 2, wherein said stent graft includes a longitudinal support member that extends substantially parallel to a longitudinal axis of said stent graft.

4. The delivery system of claim 2, wherein said stent graft includes a proximal stent that is completely covered by a graft sleeve.

5. The delivery system of claim 4, wherein said stent graft includes at least one clasping stent, said clasping stent being fixed at a proximal end of said stent graft and having at least two apices that are exposed within said stent graft.

6. The delivery system of claim 1, wherein said stent graft includes at least one proximal bare stent.

7. The delivery system of claim 1, wherein said distal portion of said distal capture portion defines a distal end and a proximal side, wherein said proximal side is along a line that intersects said longitudinal axis at an acute angle proximal to said distal end of the distal portion.

8. The delivery system of claim 7, wherein said exposed side of said proximal stopper is disposed at a proximal distance from said proximal side of said distal portion that is along the line that intersects said longitudinal axis at said acute angle proximal to said distal end of said distal portion.

9. The delivery system of claim 1, wherein the proximal capture portion includes a proximal surface that extends along a line that intersects the apex release catheter at an acute angle to a longitudinal axis of the apex release catheter proximal to the fingers.

10. A delivery system for delivering and deploying a stent graft, comprising:

a) a guidewire catheter having a distal end and an interior extending along a longitudinal axis;

b) an apex release catheter having a distal end and being slidably disposed about said guidewire catheter;

c) a hollow graft push catheter having a distal end with an end opening and being slidably disposed about said apex release catheter;

d) an apex capture device including

i) a distal capture portion fixedly connected to said distal end of said guidewire catheter, said distal capture portion having

a distal portion with a proximal end, and

a proximal stopper having an exposed side facing distally that is disposed in a place approximately perpendicular to said longitudinal axis and defining stopping surface portions, and a proximal side extending along a line that intersects with the guidewire catheter proximal to said exposed side of the proximal stopper, and

ii) a proximal capture portion fixedly connected to said distal end of said apex release catheter, and having fingers extending toward said distal capture portion in a distal direction, said fingers defining an interior cavity shaped to receive said proximal stopper therein, wherein

said proximal and distal capture portions are formed to hold proximal apices joining struts of a stent therebetween and, together, define a stent captured state in which said proximal stopper and proximal apices of the stent are received in said interior cavity to thereby constrain the proximal apices while the struts emanate radially from between the fingers of the proximal capture portion, and said distal capture portion approximately closes off said interior cavity along said longitudinal axis;

e) a relatively rigid, hollow outer catheter having a distal end and a first inner diameter;

f) a sheath catheter having a distal end and being slidably disposed about said hollow graft push catheter and slidably disposed in said outer catheter;

g) a buttress fixedly connected in said end opening at said distal end of said graft push catheter, said buttress having;

i) a body portion having a distal end and a given outer diameter and defining a central cavity in which said apex release catheter is disposed slidably; and

ii) 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

h) a relatively flexible, hollow stent graft sheath having a proximal end connected to said distal end of said sheath catheter and disposed about said apex release catheter, said sheath having a distal end and a second inner diameter greater than said first inner diameter of the hollow outer catheter, to fit therein at least a partially compressed stent graft.

11. The delivery system of claim 10, further including said stent graft about said apex release catheter and within said hollow stent graft sheath, said stent graft releasably fixed at said apex capture device.

12. The delivery system of claim 11, wherein said stent graft includes a longitudinal support member that extends substantially parallel to a longitudinal axis of the stent graft.

13. The delivery system of claim 11, wherein said stent graft includes at least one proximal bare stent.

14. The delivery system of claim 11, wherein said stent graft includes a proximal stent that is completely covered by a graft sleeve.

15. The delivery system of claim 14, wherein said stent graft includes at least one clasping stent, the clasping stent being fixed at a proximal end of the said stent graft and having at least two apices that are exposed within the said stent graft.

16. The delivery system of claim 10, wherein said distal portion of the distal capture portion defines a distal end and a proximal side of said distal capture portion, wherein said proximal side is along a line that intersects said longitudinal axis at an acute angle proximal to the distal end of said distal portion.

17. The delivery system of claim 16, wherein the exposed side of said proximal stopper is disposed at a proximal distance from said proximal side of the distal portion that is along the line that intersects said longitudinal axis at said acute angle proximal to said distal end of said distal portion.

18. The delivery system of claim 10, wherein the proximal capture portion includes a proximal surface that extends along a line that intersects the apex release catheter proximal to the fingers, and at an acute angle to a longitudinal axis of the apex release catheter.