Apparatus and method for fixation of vascular grafts

• US 7,351,258 B2
• Filed: 04/18/2002
• Issued: 04/01/2008
• Est. Priority Date: 04/20/2001
• Status: Expired due to Fees

• Current Assignee: The Research Foundation for The State University of New York (State University of New York)
• Original Assignee: The Research Foundation for The State University of New York (State University of New York)
• Inventors: Somani, Rajesh H., Ricotta, John, Hsiao, Benjamin S.
• Primary Examiner(s): Gartenberg; Ehud
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US10/501,066
• Publication Number:
  US 20050102024A1
• Time in Patent Office: 2,175 Days
• Field of Search: 623/1.36, 623/1.23
• US Class Current: 623/1.36
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• 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

Abstract

An apparatus for facilitating securement of a vascular graft within a blood vessel, includes a shaft dimensioned for passage within a blood vessel and having an expansion member movable between a contracted condition and an expanded condition and a fastener array comprising at least one fastener disposed about a peripheral portion of the expansion member. The one fastener is deployable into a wall of the blood vessel upon movement of the expansion member to the expanded condition thereof, to thereby engage the vascular graft to secure the vascular graft to a wall of the blood vessel. The fastener array preferably includes a plurality of fasteners. The fasteners may be operatively connected to each other and releasably secured to the peripheral portion of the expansion member.

Claims

1. An apparatus for securing a vascular graft within a blood vessel, the apparatus comprising:

a shaft dimensioned for passage within the blood vessel and having an expansion member, said expansion member movable between a contracted condition and an expanded condition; and

a fastener array comprising a plurality of fasteners disposed about a peripheral portion of said expansion member, said plurality of fasteners being deployable into a wall of said blood vessel upon movement of said expansion member to said expanded condition thereof, to engage and to secure the vascular graft to the wall of the blood vessel,

wherein, when the expansion member is in the contracted condition, fasteners of the fastener array are arranged in overlapping relation.

2. The apparatus according to claim 1, wherein each fastener of the plurality of fasteners has a telescopic base.

3. The apparatus according to claim 1, wherein each fastener of the fastener array is operatively connected to another fastener.

4. The apparatus according to claim 1, wherein said fasteners of said fastener array are releasably secured to said peripheral portion of said expansion member.

5. The apparatus according to claim 4 wherein the fasteners are releasably adhered to said peripheral portion of said expansion member with an adhesive.

6. The apparatus according to claim 2 wherein said fastener array defines a substantially annular arrangement whereby said fasteners are arranged about a periphery of said expansion member.

7. The apparatus according to claim 1 wherein said fasteners of said fastener array are connected to a biocompatible member, said biocompatible member being mounted about said peripheral portion of said expansion member.

8. The apparatus according to claim 7 wherein the biocompatible member is a biocompatible tape.

9. The apparatus according to claim 2, wherein the telescopic base of the fasteners permits telescoping movement while maintaining connection between adjacent fasteners of said fastener array when securing the graft.

10. The apparatus according to claim 1, wherein each fastener of said fastener array is a surgical staple having a base and penetrating legs extending from opposed ends of said base.

11. The apparatus according to claim 10 wherein said legs of each said staple define a length sufficient to penetrate through the vascular graft and lodge within the wall of the blood vessel without penetrating completely through the wall of the blood vessel.

12. The apparatus according to claim 1 wherein said expansion member is an inflatable balloon member.

13. The apparatus according to claim 1, wherein the expansion member is an umbrella mechanism.

14. The apparatus according claim 10, wherein progressive balloon inflation provides sequential deployment of the fasteners.

15. An apparatus for securing a vascular graft within a blood vessel, the apparatus comprising:

an elongated shaft having proximal and distal ends, and defining a longitudinal axis, said elongated shaft being dimensioned for passage within the blood vessel;

an expansion member supported at said distal end of said elongated shaft, said expansion member movable between contracted and expanded conditions; and

a surgical staple array including a plurality of surgical staples arranged about a peripheral portion of said expansion member, a plurality of surgical staples being arranged in partial overlapping relation, said staples of said staple array being deployable into a wall of the blood vessel upon expansion of said expansion member;

wherein, when said expansion member and said surgical staple array are within the graft positioned within the blood vessel, said expansion member expands to deploy said surgical staples, thereby engaging said surgical staples with the vascular graft and the blood vessel to secure the vascular graft within the blood vessel.

16. The apparatus according to claim 15, wherein expansion of the expansion member arranges said surgical staples of said staple array to define an annular configuration.

17. The apparatus according to claim 16 wherein the plurality of surgical staples are, when the expansion member is in the contracted condition, positioned in a superposed, compacted relation wherein adjacent ends of said the surgical staples overlap.

18. A method for securing a vascular graft within a blood vessel, the method comprising the following steps:

accessing the blood vessel;

positioning the vascular graft at a predetermined location within the blood vessel;

introducing and moving a fastener array within the blood vessel, said fastener array including a plurality of surgical fasteners arranged about a longitudinal axis of said fastener array, said surgical fasteners having penetrating portions dimensioned to penetrate the vascular graft; and

deploying said surgical fasteners of said fastener array radially outwardly relative to said longitudinal axis, wherein moving the fastener array within the blood vessel position disposes the fastener array at least partially within the vascular graft, and ends of said fasteners are overlapped prior to deploying said fastener array to provide a compacted fastener arrangement, said penetrating portions of said surgical fasteners penetrate the vascular graft and engage the blood vessel without completely penetrating the blood vessel, to thereby secure the vascular graft of the blood vessel.

19. The method according to claim 18, wherein said surgical fasteners of said fastener array are arranged with respect to each other to define a compacted substantially annular configuration whereby, upon deploying, said surgical fasteners expand and secure the substantially tubular graft to the blood vessel substantially along an outer peripheral graft wall.

20. The method according to claim 18, wherein said fasteners are sequentially deployed by an expansion member causing said surgical fastener to move radially outwardly into engagement through the vascular graft and into the blood vessel.