Debranching Stent Graft Limb and Methods for Use

Abstract

A debranching stent graft limb and methods for its use, where the limb comprises, a main body stent graft limb with a bifurcation defining a first and second leg, the main body stent graft limb has a distal end and a proximal end, the main body stent graft limb has a diameter at the proximal end in the range from about 14-18 mm, the first leg has a diameter ranging from about 8-12 mm, the second leg has a diameter ranging from about 6-10 mm, and the distance from the proximal end of the main body to the distal end of the first leg and the second leg is in the range from about 70-90 mm, and the diameter of the first leg is about 2 mm greater than the diameter of the second leg.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of the filing date of U.S. Provisional Patent Application Ser. No. 61 / 623,151, filed Apr. 12, 2012, U.S. Provisional Patent Application Ser. No. 61 / 646,637, filed May 14, 2012, U.S. Provisional Patent Application Ser. No. 61 / 716,292, filed Oct. 19, 2012, U.S. Provisional Patent Application Ser. No. 61 / 716,315, filed Oct. 19, 2012, U.S. Provisional Patent Application Ser. No. 61 / 716,326, filed Oct. 19, 2012, U.S. Provisional Patent Application Ser. No. 61 / 720,803, filed Oct. 31, 2012, U.S. Provisional Patent Application Ser. No. 61 / 720,829, filed Oct. 31, 2012, and U.S. Provisional Patent Application Ser. No. 61 / 720,846, filed Oct. 31, 2012, which are hereby incorporated by reference in their entirety.BACKGROUND OF THE INVENTION[0002]Aneurysms occur in blood vessels in locations where, due to age, disease or genetic predisposition, insufficient blood vessel strength or resiliency may cause the blood vess...

AI Technical Summary

Benefits of technology

[0070]The stent graft and methods described with respect to the twentieth through the twenty-fourth aspects of the invention provide numerous benefits. One advantage over previously known single lumen main body stent grafts, the double-barreled stent graft can also be used as a “platform” or “anchor” that enables a surgeon to debranch Great vessels, for example, while maintaining blood flow to the rest of the body without putting a patient on bypass. This anchoring main body stent graft can be utilized in combination with any embodiment of the debranching stent grafts and / or stent graft limbs disclosed herein. In one non-limiting example, the double-barreled stent graft can be used for the treatment of any aneurysm of any anatomical variation or other type of diseased aorta or traumatic injury.

[0071]Further, the double-barreled stent graft may be deployed transapically, transfemorally, via the right subclavian artery, or via any other accessible artery. Unlike previously known stent grafts, the double-barreled stent graft can be deployed in the ascending aorta. When the double-barreled stent graft is deployed in vivo, aortic flow is compartmentalized immediately, which increases surgical options by allowing the surgeon to engage in individual selection of the lumens for placement of additional debranching stent grafts. The second lumen provides a built-in back-up system in case an issue arises with stent placement in the first lumen, for example. The double-barreled stent graft also minimizes surgical impact on the patient and leads to reduced complication rates, reduced risk of renal failure, bowel ischemia, and heart attack and decreased time for patient stabilization.

[0072]In addition, the contiguous nature of the walls of the double-barreled stent graft's main body with the first and second lumens has the additional benefit of preventing extraneous blood flow into the aneurysm. The walls of the double-barreled stent graft provide a complete circumferential seal and there is no external compromise or compression of the lumen walls, which prevents blood flow through the lumens from being affected. Previous “sandwich,”“snorkel” and “chimney” devices were constructed by simultaneously placing two or more single lumen stent grafts side by side within the aorta. These previous stent grafts defined open spaces where the walls of the internal lumens did not completely abut each other or the aortic walls and allowed blood to flow through the open spaces and into the aneurysm. These previous devices were further subject to collapse or compression due to external pressures.

Problems solved by technology

Aneurysms occur in blood vessels in locations where, due to age, disease or genetic predisposition, insufficient blood vessel strength or resiliency may cause the blood vessel wall to weaken and / or lose its shape as blood flows, resulting in a ballooning or stretching of the blood vessel at the limited strength / resiliency location, thus forming an aneurysmal sac.

Left untreated, the blood vessel wall may continue to expand to the point where the remaining strength of the blood vessel wall cannot hold and the blood vessel will fail at the aneurysm location, often with fatal result.

Current stent graft systems utilize fenestrations or perforations within stent graft walls intended to be aligned with the opening of a given branch vessel, but placement of the stent graft must be very exact and operational alignment is often unsuccessful.

The techniques to marry another stent graft to that fenestration are often time consuming, require complicated surgical procedures and demand additional vessel or vascular access points.

The marrying of two stent grafts via a fenestration also has the additional problem of an inadequate seal where the two stent grafts are joined.

Further, current common iliac aneurysm treatments involve ligation or embolization of the internal iliac artery, frequently leading to side effects including, but not limited to, erectile dysfunction in men, decreased exercise tolerance, and compromise to pelvic profusion that may result in bowel ischemia and death.

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