Device and Methods for Suturing Tissue

Abstract

Systems for suturing a tissue layer having two sides with a suture be releasably retaining at least a portion of the suture in a stationary position on one side of the tissue layer. The portion of the suture is retrieved through the tissue layer from the opposite side whereby the suture is drawn from one side to the opposite side. Systems for suturing the wall of a tubular graft having two sides is also provided using a suture by releasably retaining at least a portion of the suture on one side of the wall. the portion of the length of suture is retrieved through the wall of the graft to the opposite side of the wall.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 10 / 737,668, filed Dec. 16, 2003, which is a continuation of U.S. patent application Ser. No. 10 / 033,689, filed Dec. 28, 2001, which is a continuation of U.S. patent application Ser. No. 08 / 883,246, filed Jun. 26, 1997, now U.S. Pat. No. 6,355,050, which is a continuation-in-part of U.S. patent application Ser. No. 08 / 824,031, filed Mar. 26, 1997, now U.S. Pat. No. 6,036,699, which is a continuation-in-part of U.S. patent application Ser. No. 08 / 259,410, filed Jun. 14, 1994, now U.S. Pat. No. 5,779,719, which is a divisional and a continuation-in-part of U.S. application Ser. No. 07 / 989,611, filed Dec. 10, 1992, now U.S. Pat. No. 5,417,699. The disclosures of these prior applications are hereby incorporated by reference in their entirety.FIELD OF THE INVENTION[0002]The present invention relates generally to devices and methods for the suturing of tissue in various appli...

AI Technical Summary

Benefits of technology

[0024]A device is also provided for suturing at least one tissue layer wherein each tissue layer has two sides. The device includes a fastener having at least a first and second portion. The first and second portions have means for securing the first and second portions together. The first and second portions have a base at one end to prevent the respective portion from passing completely through the tissue layer. The device includes means for releasably retaining the first portion in a stationary position on one side of the tissue layer and means for driving the second portion through the tissue layer from the opposite side and securely engaging the securing means of the first and second portions whereby the base of the first portion abuts one side of the tissue layer and the base of the second portion abuts the opposite side of the tissue layer.

Problems solved by technology

It is time-consuming, frequently requiring one-half hour or more of compression before hemostasis is assured.

This procedure is uncomfortable for the patient and frequently requires administering analgesics to be tolerable.

Moreover, the application of excessive pressure can at times totally occlude the underlying blood vessel, resulting in ischemia and / or thrombosis.

The incidence of these complications increases when the sheath size is increased and when the patient is anti-coagulated.

It is clear that the standard technique for arterial closure can be risky, and is expensive and onerous to the patient.

While the risk of such conditions can be reduced by using highly trained individuals, such use is both expensive and inefficient.

While potentially effective, this approach suffers from a number of problems.

It can be difficult to properly locate the interface of the overlying tissue and the adventitial surface of the blood vessel, and locating the fastener too far from that surface can result in failure to provide hemostasis and subsequent hematoma and / or pseudo aneurism formation.

Conversely, if the fastener intrudes into the arterial lumen, intravascular clots and / or collagen pieces with thrombus attached can form and embolize downstream causing vascular occlusion.

Also, thrombus formation on the surface of a fastener protruding into the lumen can cause a stenosis which can obstruct normal blood flow.

Other possible complications include infection as well as adverse reactions to the collagen implant.

In fact, heart disease patients often die when critical arteries, such as the coronary arteries, become significantly blocked.

Perhaps the most prevalent complication arising from prolonged cardiac bypass is the high risk of distal thrombus created by the artificial plumbing.

For example, such thrombi can embolize into the neurovasculature and potentially can cause a stroke.

It is believed that the inherent crushing force from a cross-clamp across the bridge of the muscular aortic arch may be associated with a high degree of tissue trauma and structural damage.

Additionally, hemostasis formed at or adjacent to the cross clamp, perhaps in conjunction with the tissue trauma of clamping, may also be a source of unwanted thrombogenesis.

These variables are believed to significantly affect the short or long-term success of conventional CABG anastomosis procedures.

Both of the critical CABG success indicators summarized above—time on cardiac bypass and quality of anastomosis suturing—are directly affected by inherent limitations in the devices used in conventional CABG procedures.

One procedural limitation in using conventional surgical punches is that hemostasis can not be maintained at a vessel wall after a plug of tissue is punched out and removed.

Therefore, an aperture in an aortic wall during a saphenous vein graft procedure can only be made when that portion of the aorta is cross-clamped, bypassed, and depressurized.

Otherwise, the high blood pressure and flow in the aorta would cause significant bleeding during the period from punching the aperture to forming the anastomosis.

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