Endovascular stapler

Abstract

An endovascular stapler for securing an endograft to a vessel is disclosed. The stapler includes a staple housing adapted for storing at least one staple therein, the staple housing having an exit area for discharge of the at least one staple therethrough, an actuating assembly adapted for discharging the at least one staple through the exit area, and a displacement mechanism in operative association with the staple housing near the exit area. The displacement member is operative for pushing the exit area against the endograft when discharging the at least one staple therethrough. The discharged staple forms a plurality of opposed loops connected by a central element upon discharge. Also disclosed are staples and displacement mechanisms adapted for use with surgical instruments such as the present endovascular staplers. The staples may be formed from memory metal or other metal. The displacement mechanisms disclosed include balloons and rigid offsetting devices.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present Utility patent application is a divisional application of U.S. Utility patent application Ser. No. 10 / 837,827, filed May 3, 2004, which is a continuation-in-part of U.S. Utility patent application Ser. No. 10 / 737,466 filed Dec. 16, 2003, which claims the benefit of U.S. Provisional Patent Application Ser. No. 60 / 433,692 filed Dec. 16, 2002, and U.S. Provisional Application No. 60 / 501,060 filed Sep. 8, 2003, the disclosures of the foregoing applications are hereby incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] The present invention relates to a stapling device for use in the fixation of endovascular grafts to the walls of vessels. Fixation of grafts utilizing the present invention may be conducted during initial implantation. In addition, the present invention may also be utilized to arrest the vexing complication of proximal or distal migrations following the prior implantation of such grafts. Fixation m...

AI Technical Summary

Benefits of technology

"The present invention is an endovascular stapler designed to secure an endograft to a vessel. It includes a staple housing with an exit area, an actuating assembly, and a displacement mechanism. The stapler has a balloon that can be inflated and deflated to push the staple against the endograft. The staple has two parallel straight legs connected by a central element. The stapler can be guided to a specific location within the vessel using a guide wire. The stapler can also have a trigger mechanism and a pusher to discharge the staple. The staple can penetrate the endograft and the vessel. The technical effects of the invention include improved securing of the endograft and reduced risk of complications during the procedure."

Problems solved by technology

Notwithstanding the various materials utilized, migration of the grafts over time remains a problem.

Caudad device migration is known to lead to a Type 1 endoleak with aneurysm sac reperfusion, enlargement and rupture.

Cephalad device migration may lead to coverage of the renal artery orifices and renal insufficiency.

One known factor is poor patient selection.

Patients with cone shaped aortic necks, severe neck tortuosity, short necks or who have a laminated thrombus present at the landing site are generally susceptible to device migration problems.

Other device migration issues are caused by changing aortic morphology following device implantation.

Finally, migration may be caused by device structural fatigue and device design related issues.

These late conversions are, unfortunately, associated with a high mortality rate.

Treatment options for the cephalad migrations are even less attractive.

In the face of continued migration, resignation may be the only option as such migration may lead to renal insufficiency requiring hemodialysis.

To permit device removal, a typical conversion in this case involves supra-celiac aortic cross-clamping, and its associated problems.

Prior attempts at fixation of migrating devices, including additions of hooks, barbs, tackers, and other fastening devices have proven to be insufficient or impractical.

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