Patent Description:
Iliac artery aneurysms in close proximity to the iliac bifurcation present an unmet clinical need for vascular surgeons versed in endovascular repair. One treatment option includes open surgery, which is highly invasive with associated long recovery and hospital stay times.

Another treatment option includes sacrificing the internal iliac artery by covering the internal iliac artery with a stent graft. Unfortunately, covering the internal iliac artery leads to poor quality of life from complications related to groin ischemia.

Yet another treatment option involves scaling a stent graft in the diseased (aneurysmal) common iliac artery. However, this option is associated with high rates of degeneration leading to future complications and reinterventions.

Challenges in the above options often lead the vascular surgeon to used limited commercially available iliac branch stent graft systems. The available iliac branch stent graft systems require high skill level, multiple accessory devices, and multiple surgical access points.

<CIT> describes an iliac bifurcated endoprosthesis medical apparatus.

The techniques of this disclosure generally relate to an iliac branch device having an external iliac body, a common iliac branch, and an internal iliac branch. The invention relates to an assembly as defined in claim <NUM> and to a delivery system according to claim <NUM>. A diameter of the proximal opening of the common iliac branch is greater than a diameter of a distal opening of the external iliac body. The iliac branch device is configured to be deployed without going up and over the aortic bifurcation and without using some form of supra-aortic antegrade access such as through brachial or axillary artery access. This simplifies the procedure and reduces procedure time thus maximizing the success rate of the procedure and allows the procedure to be performed on a broad patient population.

In one aspect, the present disclosure provides an assembly comprising an inner member and an iliac branch device having the inner member therein. The iliac branch device includes an external iliac body configured to be located within an external iliac artery, a common iliac branch configured to be located with a common iliac artery, and an internal iliac branch configured to perfuse an internal iliac artery.

In another aspect, the present disclosure provides a method comprising loading an iliac branch device within a delivery system having a handle. The iliac branch device includes an external iliac body, a common iliac branch, and an internal iliac branch. The external iliac body is proximal to both the common iliac branch and the internal iliac branch relative to the handle.

<FIG> is a perspective view of an iliac branch device <NUM> in accordance with one embodiment. Iliac branch device <NUM> includes an external iliac body <NUM>, internal iliac branch <NUM>, and a common iliac branch <NUM>. External iliac body <NUM>, internal iliac branch <NUM>, and common iliac branch <NUM> are sometimes called an external iliac body <NUM>, a first bifurcated leg <NUM>, and a second bifurcated leg <NUM>, respectively.

In accordance with this embodiment, external iliac body <NUM> includes distal opening <NUM> at a distal end <NUM> of external iliac body <NUM>. A proximal end <NUM> of external iliac body <NUM> is coupled to a proximal end <NUM> of internal iliac branch <NUM> and a distal end <NUM> of common iliac branch <NUM>.

Internal iliac branch <NUM> includes an internal iliac distal opening <NUM> at a distal end <NUM> of internal iliac branch <NUM>. Common iliac branch <NUM> includes a common iliac proximal opening <NUM> at a proximal end <NUM> of common iliac branch <NUM>.

As used herein, the proximal end of a prosthesis such as iliac branch device <NUM> is the end closest to the heart via the path of blood flow whereas the distal end is the end furthest away from the heart during deployment. As discussed below, blood flow enters into proximal opening <NUM> of common iliac branch <NUM> and exits distal openings <NUM>, <NUM> of external iliac body <NUM> and internal iliac branch <NUM> respectively. Generally, there is retrograde blood flow through internal iliac branch <NUM>. Accordingly, proximal end <NUM> of external iliac body <NUM> is coupled to proximal end <NUM> of internal iliac branch <NUM> and distal end <NUM> of common iliac branch <NUM> at a transition region <NUM>.

In contrast and of note, the distal end of the delivery system is usually identified to the end that is farthest from the operator/handle while the proximal end of the delivery system is the end nearest the operator/handle. For purposes of clarity of discussion, as used herein, the distal end of the delivery system is the end that is farthest from the operator (the end furthest from the handle). However, those of skill in the art will understand that depending upon the access location, iliac branch device <NUM> and/or the delivery system descriptions may be different in actual usage.

Iliac branch device <NUM> includes graft material <NUM> and one or more circumferential stents <NUM> coupled to graft material <NUM>. Graft material <NUM> may be any suitable graft material, for example and not limited to, woven polyester, DACRON® material, expanded polytetrafluoroethylene, polyurethane, silicone, electro spun materials, or other suitable materials.

Circumferential stents <NUM> may be coupled to graft material <NUM> using stitching or other means. In the embodiment shown in <FIG>, circumferential stents <NUM> are coupled to an outside surface of graft material <NUM>. However, circumferential stents <NUM> may alternatively be coupled to an inside surface of graft material <NUM>.

Although shown with a particular number of circumferential stents <NUM>, in light of this disclosure, those of skill in the art will understand that iliac branch device <NUM> may include a greater or smaller number of stents <NUM>, e.g., depending upon the desired length of external iliac body <NUM>, internal iliac branch <NUM>, and common iliac branch <NUM> and/or the intended application thereof.

Circumferential stents <NUM> may be any stent material or configuration. As shown, circumferential stents <NUM>, e.g., self-expanding members, are preferably made from a shape memory material, such as nickel-titanium alloy (nitinol), and are formed into a zig-zag configuration. The configuration of circumferential stents <NUM> is merely exemplary, and circumferential stents <NUM> may have any suitable configuration, including but not limiting to a continuous or non-continuous helical configuration. In another embodiment, circumferential stents <NUM> are balloon expandable stents. In one embodiment, bare stents and/or delivery system interfaces which increase control over delivery are included. Further, in one embodiment, there are radiopaque markers that assist in orientating iliac branch device <NUM>.

A lumen <NUM> is defined by external iliac body <NUM>. Lumen <NUM> extends between distal opening <NUM> and proximal end <NUM> of external iliac body <NUM>. External iliac body <NUM> increases in diameter from distal opening <NUM> to proximal end <NUM>. However, in other embodiments, external iliac body <NUM> is uniform in diameter or decreases in diameter from distal opening <NUM> to proximal end <NUM>.

Further, a lumen <NUM> is defined by internal iliac branch <NUM>. Lumen <NUM> extends between proximal end <NUM> and distal opening <NUM> of internal iliac branch <NUM>. Internal iliac branch <NUM> is cylindrical having a substantially uniform diameter in this embodiment. However, in other embodiments, internal iliac branch <NUM> varies in diameter.

Further, a lumen <NUM> is defined by common iliac branch <NUM>. Lumen <NUM> extends between proximal opening <NUM> and distal end <NUM> of common iliac branch <NUM>. Common iliac branch <NUM> decreases in diameter from proximal opening <NUM> to distal end <NUM>. However, in other embodiments, common iliac branch <NUM> is uniform in diameter or increases in diameter from proximal opening <NUM> to distal end <NUM>.

Generally, external iliac body <NUM> is bifurcated at proximal end <NUM> (transition region <NUM>) into internal iliac branch <NUM> and common iliac branch <NUM>. More particularly, lumen <NUM> of external iliac body <NUM> is bifurcated into lumen <NUM> of internal iliac branch <NUM> and lumen <NUM> of common iliac branch <NUM>.

In accordance with this embodiment, openings <NUM>, <NUM>, and <NUM> of external iliac body <NUM>, internal iliac branch <NUM>, and common iliac branch <NUM> have diameters D1, D2, and D3, respectively, in their relaxed and expanded configuration. Illustratively, diameter D3 is in the range of <NUM> to <NUM> millimeters (mm), diameter D2 is less than <NUM>, and diameter D1 is in the range of <NUM> to <NUM>.

In one embodiment, diameter D3 of opening <NUM> of common iliac branch <NUM> is greater than either of diameters D1 and D2 of opening <NUM> of external iliac body <NUM> and opening <NUM> of internal iliac branch <NUM>, respectively. However, in other embodiments, diameter D1 is greater than or equal to diameter D3, e.g., diameter D3 is <NUM> and diameter D1 is up to <NUM>.

<FIG> is a perspective view of an iliac branch device 100A in accordance with another embodiment. Iliac branch device 100A of <FIG> is similar to iliac branch device <NUM> of <FIG> and only the significant differences are discussed below. More particularly, iliac branch device 100A includes external iliac body <NUM> and common iliac branch <NUM> which are similar or identical to external iliac body <NUM> and common iliac branch <NUM> of iliac branch device <NUM> and so are not discussed further.

Referring now to <FIG>, an internal iliac branch 104A is curved, sometimes called having a hook shape, a "J" shape, or a "candy cane" shape. More particular, internal iliac branch 104A curves away from common iliac branch <NUM> such that distal opening <NUM> points away from common iliac branch <NUM>. The curved shape of internal iliac branch 104A facilitates cannulation of the internal iliac artery as discussed further below.

In one embodiment, internal iliac branch 104A includes a curving member <NUM> that curves internal iliac branch 104A. Curving member <NUM> includes a curved wire, stitching, or other feature that curves internal iliac branch 104A in various embodiments. A pre-shaped, curved wire could be constructed from a superelastic or traditional alloy and be attached to the inner curve of the flexible internal iliac branch 104A to force curvature. The attachment could be to the inside or outside of internal iliac branch 104A by way of suture material. Alternatively, a seamed channel could be created in the graft material of internal iliac branch 104A with the wire floating freely inside. A second (or multiple) wires(s) could further act to form this shape. Alternatively, a stitching pattern could establish a morphology of the graft material of internal iliac branch 104A that when pressurized would assume the hook shape, thus eliminating the need for a wire member.

<FIG> is a perspective view of a delivery system <NUM> including iliac branch device <NUM> of <FIG> in accordance with one embodiment. Delivery system <NUM> includes a first inner member <NUM>, a first guidewire <NUM>, a second inner member <NUM>, a second guidewire <NUM>, a distal tip <NUM>, a sheath <NUM>, and a handle <NUM>.

As illustrated in <FIG>, first and second guidewires <NUM>, <NUM> extend through lumens in first and second inner members <NUM>, <NUM>. Inner members <NUM>, <NUM> and guidewires <NUM>, <NUM> extend distally from handle <NUM> and within sheath <NUM>. Handle <NUM> has various mechanisms and ports to allow manipulation, e.g. retraction or advancement, of guidewires <NUM>, <NUM>, sheath <NUM> and/or inner members <NUM>, <NUM> relative to one another.

Distal tip <NUM> is coupled to first inner member <NUM>, e.g., the distal end thereof, and has a guidewire port <NUM> through which guidewire <NUM> extends. Second inner member <NUM> is located between first inner member <NUM> and sheath <NUM> in this embodiment.

Iliac branch device <NUM> is loaded within delivery system <NUM>. More particularly, external iliac body <NUM> and common iliac branch <NUM> are loaded over first inner member <NUM>. In other words, first inner member <NUM> enters distal opening <NUM> of external iliac body <NUM>, extends through both external iliac body <NUM> and common iliac branch <NUM> and exits proximal opening <NUM> of common iliac branch <NUM>.

Further, external iliac body <NUM> and internal iliac branch <NUM> are loaded over second inner member <NUM>. In other words, second inner member <NUM> enters distal opening <NUM> of external iliac body <NUM>, extends through both external iliac body <NUM> and internal iliac branch <NUM> and exits distal opening <NUM> of internal iliac branch <NUM>. Second guidewire <NUM> is sometimes called a prewired guidewire <NUM> in accordance with this embodiment.

Although delivery system <NUM> is illustrated and discussed as including both inner members <NUM>, <NUM> and guidewires <NUM>, <NUM>, in another embodiment, delivery system includes either inner member <NUM>/guidewire <NUM> or inner member <NUM>/guidewire <NUM>, but not both.

Further, although a particular arrangement of loading of iliac branch device <NUM> within delivery system <NUM> is illustrated and discussed, other arrangements and delivery systems are used in other embodiments. Generally, iliac branch device <NUM> is loaded such that external iliac body <NUM> is proximal (relative to handle <NUM>) to both internal iliac branch <NUM> and common iliac branch <NUM>. Iliac branch device <NUM> is sometime said to be loaded backwards within the delivery system.

Two guidewires are potentially used. The primary guidewire runs through common iliac branch <NUM>. The second guidewire runs through internal iliac branch <NUM>. In other embodiments, a single guidewire is used. Other arrangements are possible.

<FIG> illustrates delivery system <NUM> in a deployed (or pre-loading) state where sheath <NUM> is withdrawn to expose iliac branch device <NUM> for purposes of illustrating the various features of delivery system <NUM>. When in a delivery state, sheath <NUM> abuts distal tip <NUM> and iliac branch device <NUM> is constrained between sheath <NUM> and inner members <NUM>, <NUM>.

To deploy iliac branch device <NUM>, delivery system <NUM> is advanced over first guidewire <NUM> to the desired deployment location. For example, delivery system <NUM> is introduced through an ipsilateral external iliac artery access point and advanced to the desired deployment location. Once at the deployment location, sheath <NUM> is retracted thus releasing iliac branch device <NUM>. Once released, iliac branch device <NUM>, e.g., stents <NUM>, self-expands (or is balloon expanded) to be secured in the deployment location.

In one embodiment, upon retraction of sheath <NUM> and deployment of iliac branch device <NUM>, iliac branch device <NUM> assumes a configuration similar to that illustrated in <FIG>. In accordance with this embodiment, internal iliac branch <NUM> is deployed as a straight member.

In another embodiment, second inner member <NUM> is a resilient curved member. Second inner member <NUM> is constrained in a straight state by sheath <NUM> when in a delivery state. Upon being deployed and released from sheath <NUM>, second inner member <NUM> resumes the curved state of second inner member <NUM>. Curvature of second inner member <NUM> causes curvature of internal iliac branch <NUM> as illustrated by the dashed lines in <FIG>.

In another embodiment, iliac branch device 100A of <FIG> is loaded within delivery system <NUM> instead of iliac branch device <NUM> of <FIG>. In accordance with this embodiment, referring to <FIG> together, internal iliac branch 104A is constrained in a straight state by sheath <NUM> when in a delivery state. Upon being deployed and released from sheath <NUM>, internal iliac branch 104A resumes the curved state of internal iliac branch 104A as illustrated by the dashed lines in <FIG>.

<FIG> is a partial cross-sectional view of a vessel assembly <NUM> including iliac branch device <NUM> of <FIG> in accordance with one embodiment. <FIG> is an enlarged view of the region V of vessel assembly <NUM> of <FIG> in accordance with one embodiment. Referring to <FIG> and <FIG> together, vessel assembly <NUM> illustrates a series of vessels within the human body, including the aorta <NUM>, the common iliac arteries <NUM>, <NUM>, internal iliac arteries <NUM>, <NUM>, and external iliac arteries <NUM>, <NUM>.

More particularly, the aorta <NUM> descends to an aortic bifurcation <NUM> from which extends common iliac arteries <NUM>, <NUM>. Common iliac artery <NUM> descends to a common iliac artery bifurcation <NUM> from which extends internal iliac artery <NUM> and external iliac artery <NUM> at a contralateral side. Similarly, common iliac artery <NUM> descends to a common iliac artery bifurcation <NUM> from which extends internal iliac artery <NUM> and external iliac artery <NUM> at an ipsilateral side. In accordance with this example, common iliac artery <NUM> includes an iliac artery aneurysm <NUM>, i.e., a diseased section of tissue.

Referring now to <FIG> and <FIG> together, iliac branch device <NUM> is deployed within common iliac artery <NUM> and external iliac artery <NUM>. For example, as discussed above, delivery system <NUM> introduced through an ipsilateral external iliac artery access point and advanced to the desired deployment location within common iliac artery <NUM> and external iliac artery <NUM>. Sheath <NUM> is retracted such that iliac branch device <NUM> is deployed with common iliac branch <NUM> within common iliac artery <NUM> and external iliac body <NUM> is deployed within external iliac artery <NUM>. Distal opening <NUM> is adjacent to common iliac artery bifurcation <NUM> and generally adjacent or distal of the ostium of internal iliac artery <NUM>. External iliac body <NUM> provides the distal seal within external iliac artery <NUM>.

In accordance with this embodiment, second guidewire <NUM> is located within internal iliac artery <NUM>. For example, second guidewire <NUM> is prewired as discussed above in reference to <FIG> and delivery system <NUM>. However, in another embodiment, delivery system <NUM> does not include prewired guidewire <NUM>, and guidewire <NUM> is advanced and manipulated to cannulate internal iliac artery <NUM>.

<FIG> is a partial cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of a bridging graft <NUM> in accordance with one embodiment. Referring now to <FIG> and <FIG> together, bridging graft <NUM> is deployed within internal iliac branch <NUM> and internal iliac artery <NUM>.

To deploy bridging graft <NUM>, a delivery system including bridging graft <NUM> is inserted at the same access point as the access point used for iliac branch device <NUM>, e.g., the ipsilateral external iliac artery access point. The delivery system is advanced over guidewire <NUM> and into internal iliac artery <NUM>. Bridging graft <NUM> is then deployed from the delivery system, e.g., by withdrawing a sheath thereof. Upon deployment, bridging graft <NUM> self-expands (or is balloon expanded) to be located within internal iliac branch <NUM> and internal iliac artery <NUM>. Guidewire <NUM> is removed.

Bridging graft <NUM> bridges blood flow from internal iliac branch <NUM> to internal iliac artery <NUM>. In one embodiment, bridging graft <NUM> includes graft material <NUM> and one or more stents <NUM>. Graft material <NUM> and stents <NUM> are the same or similar to graft material <NUM> and stents <NUM> as discussed above.

Referring now to <FIG>, <FIG>, and <FIG> together, once deployed, blood flow enters into proximal opening <NUM> of common iliac branch <NUM>. Blood flows through lumen <NUM> of common iliac branch <NUM> to transition region <NUM>. At transition region <NUM>, a portion of the blood flows through lumen <NUM> of external iliac body <NUM> and out distal opening <NUM>. Another portion of the blood flows through lumen <NUM> of internal iliac branch <NUM>, through bridging graft <NUM>, and perfuses internal iliac artery <NUM>. Blood flow through internal iliac branch <NUM> is retrograde (backwards) blood flow. However, there is a sufficient amount of perfusion of internal iliac artery <NUM> through the retrograde blood flow to avoid serious medical complication from obstruction of internal iliac artery <NUM>.

Iliac branch device <NUM> and bridging graft <NUM> are deployed from the same ipsilateral external iliac artery access point. Of note, iliac branch device <NUM> and bridging graft <NUM> are deployed without going up and over aortic bifurcation <NUM> and without using some form of supra-aortic antegrade access such as through brachial or axillary artery access. This simplifies the procedure and reduces procedure time thus maximizing the success rate of the procedure and allows the procedure to be performed on a broad patient population.

<FIG> is an enlarged view of the region V of vessel assembly <NUM> of <FIG> after deployment of iliac branch device 100A of <FIG> in accordance with one embodiment. The deployment of iliac branch device 100A of <FIG> is similar to the deployment of iliac branch device <NUM> of <FIG> and only the significant differences are discussed below.

In accordance with this embodiment, distal opening <NUM> of internal iliac branch 104A is located directly adjacent and proximal to the ostium of internal iliac artery <NUM>. Due to the curvature of internal iliac branch 104A, distal opening <NUM> points towards the ostium of internal iliac artery <NUM>. This simplifies cannulation of internal iliac artery <NUM> with guidewire <NUM> as the curvature of internal iliac branch 104A facilitates guiding of guidewire <NUM>.

<FIG> is a partial cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage during deployment of bridging graft <NUM> in accordance with one embodiment. Referring now to <FIG> and <FIG> together, bridging graft <NUM> is deployed within internal iliac branch 104A and internal iliac artery <NUM> in a manner similar to that discussed above regarding deployment of bridging graft <NUM> into internal iliac branch <NUM> and internal iliac artery <NUM> of <FIG>.

<FIG> is a partial cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage after deployment of an aortic bifurcated stent graft <NUM> in accordance with one embodiment. Referring now to <FIG>, <FIG>, and <FIG> together, in accordance with this embodiment, aorta <NUM> includes an aortic aneurysm <NUM>. In accordance with this embodiment, aortic bifurcated stent graft <NUM> excludes aortic aneurysm <NUM>. However, in another embodiment, aorta <NUM> is healthy, i.e., does not include an aneurysm.

More particularly, aortic bifurcated stent graft <NUM> includes a main body <NUM>, a first leg <NUM>, and a second leg <NUM>. Examples of aortic bifurcated stent graft <NUM> includes the Endurant® II AAA stent graft system manufactured by Medtronic or other AAA EVAR devices.

In one embodiment, aortic bifurcated stent graft <NUM> is deployed distal of renal arteries <NUM>, <NUM> although the deployment location various in other embodiments depending upon the particular application of aortic bifurcated stent graft <NUM>. A first bridging graft <NUM> is deployed within and bridges first leg <NUM> and common iliac artery <NUM>. A second bridging graft <NUM> is deployed within and bridges second leg <NUM> and common iliac branch <NUM>.

<FIG> is an enlarged view of the region X of vessel assembly <NUM> of <FIG> in accordance with one embodiment. <FIG> illustrates a first component A within a second component B.

Referring now to <FIG> and <FIG> together, illustratively, aortic bifurcated stent graft <NUM> and iliac branch device <NUM> are initially deployed. After deployment of aortic bifurcated stent graft <NUM> and iliac branch device <NUM>, bridging graft <NUM> is deployed within second leg <NUM> and common iliac branch <NUM>. In accordance with this embodiment, first component A is representative of bridging graft <NUM> and second component B is representative of common iliac branch <NUM>. As illustrated in <FIG>, bridging graft <NUM> (component A) is deployed within and overlaps common iliac branch <NUM> (component B) thus forming a seal between bridging graft <NUM> and common iliac branch <NUM>.

<FIG> is an enlarged view of the region X of vessel assembly <NUM> of <FIG> in accordance with another embodiment. <FIG> illustrates second component B within first component A.

Referring now to <FIG> and <FIG> together, in accordance with this embodiment, aortic bifurcated stent graft <NUM> and bridging graft <NUM> are initially deployed. Illustratively, aortic bifurcated stent graft <NUM> and bridging graft <NUM> provide sufficient exclusion of aortic aneurysm <NUM>.

However, after a period of time, aortic bifurcated stent graft <NUM> and bridging graft <NUM> do not provide sufficient exclusion. Illustratively, aortic aneurysm <NUM> grows and/or iliac aneurysm <NUM> is formed or grows. Accordingly, at a later point in time in a follow on procedure, iliac branch device <NUM> is deployed to provide sufficient exclusion of aneurysms <NUM> and/or <NUM>.

More particularly, common iliac branch <NUM> is deployed within bridging graft <NUM>. In accordance with this embodiment, first component A is representative of bridging graft <NUM> and second component B is representative of common iliac branch <NUM>. As illustrated in <FIG>, common iliac branch <NUM> (component B) is deployed within and overlaps bridging graft <NUM> (component A) thus forming a seal between common iliac branch <NUM> and bridging stent graft <NUM>.

In yet another embodiment, aortic bifurcated stent graft <NUM> and bridging stent graft <NUM> are initially deployed and iliac branch device <NUM> is then deployed in a single procedure.

<FIG> is a partial cross-sectional view of vessel assembly <NUM> of <FIG> at a later stage after deployment of aortic bifurcated stent graft <NUM> in accordance with another embodiment. Vessel assembly <NUM> as illustrated in <FIG> is similar to vessel assembly <NUM> as illustrated in <FIG> except bridging graft <NUM> of <FIG> is not used in accordance with the embodiment of <FIG>.

Referring now to <FIG>, <FIG>, and <FIG> together, in accordance with this embodiment, common iliac branch <NUM> is joined directly with second leg <NUM> of aortic bifurcated stent graft <NUM>. Illustratively, second leg <NUM> and/or common iliac branch <NUM> are extended to overlap one another.

<FIG> is an enlarged view of the region X of vessel assembly <NUM> of <FIG> in accordance with this embodiment. Referring now to <FIG> and <FIG> together, in accordance with this embodiment, aortic bifurcated stent graft <NUM> is initially deployed. Illustratively, aortic bifurcated stent graft <NUM> provides sufficient exclusion of aortic aneurysm <NUM>.

However, after a period of time, aortic bifurcated stent graft <NUM> does not provide sufficient exclusion. Illustratively, aortic aneurysm <NUM> grows and/or iliac aneurysm <NUM> is formed or grows. Accordingly, iliac branch device <NUM> is deployed to provide sufficient exclusion of aneurysms <NUM> and/or <NUM>.

More particularly, common iliac branch <NUM> is deployed within second leg <NUM>. In accordance with this embodiment, first component A is representative of second leg <NUM> and second component B is representative of common iliac branch <NUM>. As illustrated in <FIG>, common iliac branch <NUM> (component B) is deployed within and overlaps second leg <NUM> (component A) thus forming a seal between common iliac branch <NUM> and second leg <NUM>.

In yet another embodiment, aortic bifurcated stent graft <NUM> is initially deployed and iliac branch device <NUM> is then deployed in a single procedure.

<FIG> is an enlarged view of the region V of vessel assembly <NUM> of <FIG> in accordance with one embodiment. Referring to <FIG> and <FIG> together, in accordance with this embodiment, vessel assembly <NUM> includes only an isolated iliac aneurysm <NUM>. In accordance with this embodiment, iliac branch device <NUM> alone provides sufficient exclusion of iliac aneurysm <NUM>. Illustratively, common iliac branch <NUM> forms a proximal seal with common iliac artery <NUM>. External iliac body <NUM> forms a distal seal with external iliac artery <NUM>. Internal iliac branch <NUM> and bridging graft <NUM> form the distal seal with internal iliac artery <NUM>. In this manner, isolated iliac aneurysm <NUM> is excluded by iliac branch device <NUM> alone.

In one embodiment, after a period of time, iliac branch device <NUM> does not provide sufficient exclusion. Illustratively, aortic aneurysm <NUM> is formed and/or iliac aneurysm <NUM> grows. Accordingly, aortic bifurcated stent graft <NUM> is deployed to provide sufficient exclusion of aneurysms <NUM> and/or <NUM>.

More particularly, referring to <FIG>, <FIG>, second leg <NUM> of aortic bifurcated stent graft <NUM> is deployed with common iliac branch <NUM>. In accordance with this embodiment, first component A is representative of second leg <NUM> and second component B is representative of common iliac branch <NUM>. As illustrated in <FIG>, second leg <NUM> is deployed within and overlaps common iliac branch <NUM> thus forming a seal between common iliac branch <NUM> and second leg <NUM>.

In yet another embodiment, iliac branch device <NUM> is initially deployed and aortic bifurcated stent graft <NUM> is then deployed in a single procedure.

Although <FIG>, <FIG>, <FIG>, <FIG> and <FIG> are discussed above as including iliac branch device <NUM> of <FIG>, in other embodiments, iliac branch device 100A as illustrated in <FIG> is used in place of iliac branch device <NUM>. Accordingly, the discussion regarding iliac branch device <NUM> in <FIG>, <FIG>, <FIG> is equally applicable to iliac branch device 100A.

Claim 1:
An assembly comprising:
an iliac branch device (<NUM>, 100A) comprising:
an external iliac body (<NUM>) comprising a distal opening (<NUM>);
a common iliac branch (<NUM>) comprising a proximal opening (<NUM>), a diameter of the proximal opening (<NUM>) being greater than a diameter of the distal opening (<NUM>); and
an internal iliac branch (<NUM>, 104A) configured to perfuse an internal iliac artery (<NUM>, <NUM>);
wherein the external iliac body (<NUM>) is bifurcated into the common iliac branch (<NUM>) and the internal iliac branch (<NUM>, 104A) at a transition region (<NUM>).