Vascular bypass grafting instrument and method

Abstract

An instrument for attaching a graft to an aorta includes a first needle assembly for breaching the aorta to provide a hole in a wall thereof, and a carrier portion for insertion of an end of a tubular graft through the hole and into the aorta. Arms are pivotally mounted on the instrument and are moveable from a position extending axially of the carrier to a position extending radially from the carrier to spread the end of the graft radially outwardly from a tubular portion of the graft to form an annular flange extending outwardly from the tubular portion, and to support the flange within the aorta and around the hole therein. A second needle assembly retains the suture material and advances the suture material into engagement with the aorta wall and the graft flange for suturing the graft flange to the aorta wall.

Description

REFERENCE TO PENDING PRIOR PATENT APPLICATION [0001] This patent application claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 60 / 229,675, filed Sep. 1, 2000 by William J. Allen et al. for VASCULAR BYPASS GRAFTING SYSTEM, which patent application is hereby incorporated herein by reference.FIELD OF THE INVENTION [0002] The invention relates to a fastener and a delivery instrument for joining multiple layers of thin flexible material. More particularly, the invention relates to a surgical fastener and a delivery instrument and method for joining living tissue and / or synthetic materials which may be used as a substitute for tissue. [0003] Still more specifically, the invention relates to a system for joining large grafts to the human aorta less invasively and with substantially less blood loss than is typically experienced in this type of operation. The invention further permits the graft to be anastomosed to the aorta without temporarily stopping the flow of...

AI Technical Summary

Benefits of technology

[0015] Accordingly, an object of the present invention is to provide a surgical fastener that can access internal tissue through a small surgical access port or incision.

[0016] It is a further object of the present invention to provide a surgical fastener that can be applied remotely.

[0017] It is yet another object of the present invention to provide a surgical fastener that uses the superelastic properties of shape memory alloy without having to apply heat to the fastener.

[0019] A still further object of the present invention is to provide an improved instrument and method for delivering a graft to the operative site, puncturing the aorta, and making an anastomosis quickly and reliably through a small incision, and with minimal loss of blood and reduced heart strain.

[0020] These objects of the invention are achieved by a surgical fastener preferably made from a shape memory alloy that accesses internal tissue or other synthetic material through a small surgical access port or incision. After the fastener is deployed through layers of tissue, it assumes a shape that automatically applies to the layers of tissue an appropriate hemostatic compression which is relatively independent of tissue thickness. The fastener is a suitable replacement for conventional non bio-absorbable sutures and staples in certain clinical applications. Its shape, method of deployment, and low force requirements make it suitable for standard surgical procedures and especially suitable for laparoscopic and other less invasive surgery where access to the wound site is limited, including endovascular surgery. The invention is expected to be especially useful for attaching synthetic grafts to an aorta.

Problems solved by technology

Excess tension can cause necrosis (the localized death of living tissue) and eventual failure of the repair.

Furthermore, the application of staples requires that there be enough space for an instrument, which can produce the necessary force to form the staple against the anvil.

Stapling, however, is generally faster and, as previously noted, requires a lower level of skill.

Instruments developed for less invasive suturing, on the other hand, are slow and cumbersome and do not solve the essential problem of tensioning the suture and tying the knot remotely.

Suturing is feasible but difficult.

Conventional stapling is not feasible because an anvil cannot access the distal side of the tissue.

This fastener, however, does not produce compression upon the synthetic and natural tissue layers and thus does not produce hemostasis because the fastener is screwed into the wound site in its natural shape.

Because this fastener does not produce hemostasis, it may not be suitable for a wide range of surgical applications.

As noted above, however, sutures and staples are not always desirable for all surgical applications.

Stents, which are currently used for this purpose, are often insufficiently compliant to prevent leakage and consequent failure of the repair.

There are problems associated with both of these bypass techniques.

In general, the most difficult part of the procedure with respect to the human aorta is in making the initial connection to the wall of the aorta.

The potential for blood loss is significant due to the large volume of blood and relatively high systolic pressure in the aorta.

In addition, the need to use a blocking clamp to prevent blood loss introduces a significant strain on the heart.

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