FIELD OF THE INVENTION

The present invention relates generally to endovascular grafts (“endografts”) for evaluation and repair of damaged or aneurismal blood vessels. More particularly, it relates to universal fenestrated and universal branched endografts for repair of blood vessels with branches, methods for repairing blood vessels and for making connection with one or more branches.

BACKGROUND OF THE INVENTION

Endografts are artificial grafts typically composed of metal and fabric that are placed inside the arteries or veins to treat aneurysms, dissections, stenosis or injuries. Endografts cover the diseased segments of the vessels, and typically the ends of endografts are positions against non-diseased portions. Placement of endografts typically is done from a remote site, usually the common femoral artery.

Since the first English publication of a study describing the clinical application of an endograft to treat an aneurysm (Annals of Vascular Surgery 1991; 5:491), endografting has expanded worldwide. In 2010, approximately 107,000 endografts were applied for aortic aneurysms globally.

In many cases, the damaged or defected portion of the vessel being treated may include branches. For example, in the case of the abdominal aorta, there are at least three branch vessels, including the celiac, mesenteric, and renal arteries, leading to various other organs. Thus, when the damaged portion of the vessel includes one or more of these branch vessels, some accommodation must be made to ensure that the endograft does not block or hinder blood flow through the branch vessel.

Attempts to maintain blood flow to branch vessels have included providing one or more fenestrations or holes in the side wall of the endograft. Other attempts have included providing an endograft in which the branch vessel portion of the vessel is spanned by wires or the like. Generally, this treatment involves aligning the fenestrations with the branch vessels, which may extend approximately at right angles on both sides from the aorta.

In many cases, the vasculature is not symmetric. In addition, even with symmetrical vasculature, physiological forces may cause a previously placed branch vessel endograft to shift causing the position of the fenestration to offset from the branch. In other instances, the diseased vasculature may extend into the branch vessel itself.

When treating a vessel with an endograft, it is sometimes beneficial to deploy a secondary endograft extending from the primary endograft to a side branch vessel so that the blood flow into the branch vessel is not impeded. Branch vessel endografts can form a connection to primary endografts through fenestrations to complete the prosthesis. Furthermore, some aneurysms extend into the branch vessels in both the thoracic and abdominal aorta. Deploying prostheses with prosthetic branches into these vessels may help prevent expansion and/or rupture of these aneurysms.

Limitations for the use of endografts in the aorta are related to short or angulated landing zones. When visceral or supra-aortic branches split off from an aneurysm, endografts need to have fenestrations or branches similar to those used in short proximal necks (landing zones). When fenestrations or branches are needed, custom-made devices are constructed that take into account distances and angles indicated in aortic images of a patient. Custom made devices have been constructed until now with good results, but such devices are expensive and take a relatively long time to manufacture. Further, the custom nature of the device adds complexity to the procedure of implantation, due to, among other reasons, inconsistent designs. Additionally, it is frequently difficult to accurately and precisely guide the instrumentation needed to cannulate the branch to the branch ostium. Thus, it would be beneficial for an endograft to have structures connecting the lumen of the endograft to the fenestration and the branch artery ostium; thus facilitating cannulation of the branch arteries and a continuation of procedures without extra incisions or unnecessary arterial approaches. Accordingly, there is need to address these issues.

BRIEF SUMMARY OF THE INVENTION

In order to facilitate the procedure and provide an “off the shelf” device, the following invention was developed. The universal endografts described below could be used for all, or most, of the patients with similar conditions.

Referring now to the universal fenestrated endograft of the present invention, one aspect of the invention relates to an endograft with orifices or fenestrations to facilitate connection between an endograft placed in an artery or vessel and branches of other arteries and vessels. In one embodiment, fenestrations are located within the walls of an endograft. In another embodiment, the endograft may additional comprise cannulation members engaged to said fenestrations. Cannulation members generally comprise an external orifice, a cavity, a tubular segment, and an internal orifice. The external orifice may further comprise an inner and outer rim. In one embodiment, the internal orifice of the cannulation member from the lumen of the universal fenestrated endograft. This direct connection from the lumen of the universal fenestrated endograft to the branch artery facilitates efficient treatment of branch arteries without the need of extra incision or arterial approaches other than femoral access.

As the external orifice of the universal fenestrated endograft of the present invention has dimensions that accommodate most arterial or venous branch morphology, the device is called a universal fenestrated endograft. For example, in one embodiment, the external orifice of the cannulation member may be wide enough to accommodate anatomical variations of the aortic arch, as well as areas of the visceral arteries in the abdominal aorta.

In one embodiment of the universal fenestrated endograft of the present invention, openings or fenestrations may cover all of the variations of the site of the extensions of the branches of the vessels. The tubular segment of the cannulation member may connect to the proximal lumen of the branch vessel through an endograft interposed between them. Furthermore, the inner orifice of the cannulation member may have a flared end to facilitate cannulation.

In another embodiment of the universal fenestrated endograft of the present invention, fenestrations and the corresponding cannulation member may be constructed as a part of the main universal fenestrated endograft wherein the cannulation member is independent or shares segments between the cannulation member and the endograft.

Catheters and other instrumentation may be introduced in the tubular segment of the cannulation member reaching the cavity of the cannulation member and the fenestration. Ostia of the branch vessels may be cannulated and connection with a tubular endograft is established between the tubular segment of the cannulation member and the trunk of the branch vessel, for example, the initial about 1.5 to 2 cm of the vessel.

In another aspect of the universal fenestrated endograft of the present invention, when the cannulation member accommodates multiple branches, in one embodiment, procedures may be performed from different chambers constructed within the tubular segment of the cannulation member to the different vessel branches. In another embodiment, independent cannulation members may be constructed wherein each cannulation member uses the same universal fenestration to access the different vessel branches.

In another aspect of the universal fenestrated endograft of the present invention, walls of the cannulation member may be a part of the endograft, constitute a braided cannulation member attached to the edge of the fenestration, or make up a malleable cannulation member attached to the edge of the fenestration, wherein, in this latter case, a balloon of very low profile is placed inside the cannulation member and the cannulation member is compressed and collapsed over the balloon.

In another aspect of the universal fenestrated endograft of the present invention, guiding elements, for example, guide wires or fabric threads, are used to guide catheters inside the cannulation member. Wires and threads may be attached outside the fenestration, pass the fenestration and come out through an orifice of the valve of the introducer sheath.

In another aspect of the universal fenestrated endograft of the present invention, segments of the aorta or iliac arteries in which universal fenestrated endograft could be used include: an aortic arch; visceral segment of the abdominal aorta; and iliac bifurcation in cases of iliac aneurysms.

Another embodiment of the invention relates to a universal fenestrated endograft having a body extended along a longitudinal axis, the body being expandable and having a first end, a second end, a first wall, a second wall, and an interior passage or lumen there between when expanded. The body may include openings in communication with the passage at the first and second ends, the openings being substantially transverse to the longitudinal axis. The body may include one or more lateral fenestrations in communication with the lumen at the first or second end. The body may have a necked portion between the ends and may further have a cannulation member contained therein.

In one embodiment, the body, including the cannulation member, has a braided construction.

In another embodiment, the body may comprise a scallop for receiving a branch artery, for example, the superior mesenteric artery. For example, a scallop may be used to prevent coverage of the superior mesenteric artery when a universal fenestrated endograft is used to connect the renal arteries.

Another embodiment of the invention relates to a method for repairing a patient's blood vessel. In the method a universal fenestrated endograft is obtained, as described herein and implanted to affect a therapeutic result.

Referring now to the universal branched endograft of the present invention, in one embodiment of the invention a universal branched endograft device comprises a tubular body with a main lumen and four branch lumens, with a large branch extending from the body. The large branch may be in fluid communication with the main lumen. The four branch lumens may be positioned about a circumference of the tubular body, and each configured to connect to a tubular endograft.

In one aspect of the first embodiment of the universal branched endograft, each branch lumen can include a tubular extension configured for connecting to a target branch artery.

In another aspect of the embodiment of the universal branched endograft, the large branch can be configured to connect with a distal aorta or an iliac artery.

In another aspect of the embodiment of the universal branched endograft, each lumen includes a stent-like frame.

In another aspect of the embodiment of the universal branched endograft, the tubular body is at least about 6 cm in length.

Another embodiment of the invention regards a method for using the universal branched device. In the method, the universal branched device may be obtained and implanted within a patient to treat a thoraco-abdominal aneurysm.

In one aspect of the method, a guiding element is fed from a femoral cut down to the thoracic aorta. The universal branched endograft with aortic extensions can be put into place via the guiding element, and the universal branched endograft is cannulated to a superior mesenteric artery (SMA), celiac axis and renal arteries.

