Expandable graft assembly and method of use

• US 5,723,003 A
• Filed: 01/16/1996
• Issued: 03/03/1998
• Est. Priority Date: 09/13/1994
• Status: Expired due to Fees

• Current Assignee: Ultrasonic Sensing and Monitoring Systems Incorporated
• Original Assignee: Ultrasonic Sensing and Monitoring Systems Incorporated
• Inventors: Neet, John, Winston, Thomas R.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US08/585,470
• Time in Patent Office: 777 Days
• Field of Search: 623/1, 623/12, 606/191, 606/192, 606/194, 606/195, 606/108
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• 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 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/30467 using hook and loop-type fasteners
• 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 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A graft assembly is provided for placement in a body passage having a generally tubular inner wall of predetermined diameter. The graft assembly includes an elongated outer tubular graft presenting inner and outer graft surfaces, and first and second outer stents secured to the graft. The first outer stent has expanded and contracted conditions and possesses a spring force that urges the first outer stent toward the expanded condition. When in the expanded condition, the first stent presents an outer diameter greater than the predetermined diameter of the inner wall of the body passage. The second outer stent also has expanded and contracted conditions and possesses a spring force that urges the second outer stent toward the expanded condition. However, the second outer stent, in the expanded condition, presents an outer diameter substantially equal to the predetermined diameter of the inner wall of the body passage so that the second outer stent supports the graft at the position spaced from the first outer stent.

Claims

1. A graft assembly for placement in a body passage having a generally tubular inner wall of predetermined diameter, the graft assembly comprising:

an elongated tubular graft presenting inner and outer graft surfaces;

a first outer stent retained on said outer graft surface and having expanded and contracted conditions and possessing a spring force that urges the first outer stent toward the expanded condition, the first outer stent when in the expanded condition presenting an outer diameter greater than the predetermined diameter of the inner wall of the body passage;

a means for securing the first outer stent to the outer surface of the graft;

a second outer stent secured to the graft at a position longitudinally spaced from the first outer stent, the second outer stent having expanded and contracted conditions and possessing a spring force that urges the second outer stent toward the expanded condition, the second outer stent when in the expanded condition presenting an outer diameter smaller than the outer diameter of the first outer stent so that the second stent supports the graft at the position spaced from the first outer stent; and

a means for securing the second outer stent to the outer surface of the graft; and

a plurality of inner stents provided along the inner graft surface of the graft and sleeved within the first and second outer stents, each of the inner stents being movable between expanded and contracted conditions and possessing a spring force that urges the inner stent toward the expanded condition, the inner stents when in the expanded condition pressing the graft against the first and second outer stents.

2. A graft assembly as recited in claim 1, wherein the first outer stent includes a roll that, in the expanded condition, has at least two overlapping layers bearing against one another along substantially the entire circumference of the roll.

3. A graft assembly as recited in claim 2, wherein the roll is formed from a flexible sheet of stainless steel foil.

4. A graft assembly as recited in claim 1, wherein the means for securing the first outer stent to the graft includes a mechanical connection which provides a friction holding force of the graft when the first outer stent is in the expanded condition.

5. A graft assembly as recited in claim 1, wherein the means for securing the first stent to the graft includes an adhesive.

6. A graft assembly as recited in claim 1, wherein the second stent includes a roll that, in the expanded condition, has at least two overlapping layers which bear against one another along substantially the entire circumference of the roll.

7. A graft assembly as recited in claim 6, wherein the roll of the second stent is formed of metal.

8. A graft assembly as recited in claim 1, wherein a plurality of second outer stents are secured to the outer graft, and each second outer stent is spaced longitudinally from adjacent outer stents.

9. A graft assembly for placement in a body passage having a generally tubular inner wall of predetermined diameter, the graft assembly comprising:

an elongated outer tubular graft presenting inner and outer graft surfaces;

a first outer stent retained on said outer graft surface, the first outer stent having expanded and contracted conditions and possessing a spring force that urges the first outer stent toward the expanded condition, the first outer stent when in the expanded condition presenting an outer diameter greater than the predetermined diameter of the inner wall of the body passage;

a second outer stent secured to the graft at a position longitudinally spaced from the first outer stent, the second outer stent having expanded and contracted conditions and possessing a spring force that urges the second outer stent toward the expanded condition, the second outer stent when in the expanded condition presenting an outer diameter smaller than the outer diameter of the first outer stent so that the second stent supports the graft at the position spaced from the first outer stent;

a plurality of inner stents provided along the inner graft surface of the outer graft and sleeved within the first and second outer stents, each of the inner stents being movable between expanded and contracted conditions and possessing a spring force that urges the inner stent toward the expanded condition, the inner stents when in the expanded condition pressing the outer graft against the first and second outer stents; and

at least one elongated inner tubular graft presenting inner and outer graft surfaces, and an attachment means for attaching the at least one inner tubular graft to the outer tubular graft with the at least one inner tubular graft covering the inner stents to shield the inner stents from direct exposure to the body passage.

10. A graft assembly as recited in claim 9, wherein the attachment means includes a mechanical fastener between the inner and outer grafts that is secured when the inner graft is pressed against the outer graft.

11. A graft assembly as recited in claim 10, wherein the fastner includes a hook material supported on one of the grafts and a loop material supported on the outer graft, wherein the material adhere to one another when the grafts are brought into mutual contact.