Stent graft with features for side branch vessel perfusion - Patent Application 20070122999

Abstract

An endovascular treatment system including branch features for perfusing branch vessels such as the renal arteries, celiac arteries, and mesenteric arteries (e.g., for treating aortic aneurysms).

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Application No. 18 / 436,294, filed February 8, 2024, which claims the benefit of Provisional Application No. 63 / 444,382, filed February 9, 2023, which applications are incorporated by reference herein in their entireties for all purposes. [Background technology]

[0002] background Aneurysms develop in blood vessels where the vessel wall is insufficiently strong or elastic due to a patient's age, disease, or genetic predisposition to prevent the vessel wall from ballooning or stretching as blood passes through it. If left untreated, an aneurysm can cause the vessel wall to expand and rupture, often resulting in death.

[0003] To prevent aneurysm rupture, a stent graft can be percutaneously introduced into the blood vessel and deployed to span the aneurysmal sac. The stent graft comprises a graft fabric secured to a tubular backbone or framework of one or more stents. The stents provide the rigidity and structure to hold the graft open in a tubular configuration and provide the outward radial force necessary to form a seal between the graft and the healthy portion of the vessel wall and provide resistance to migration. Blood flowing through the vessel is directed through the luminal surface of the stent graft, reducing, if not completely eliminating, stress on the vessel wall at the location of the aneurysmal sac. The stent graft reduces the risk of vessel wall rupture at the aneurysm site and allows blood to flow uninterrupted through the vessel.

[0004] However, various endovascular repair procedures, such as aneurysm removal, require the implantation of a stent graft adjacent to a vessel bifurcation. Often, the aneurysm extends to the bifurcation, requiring the stent graft to be placed within the bifurcation. Therefore, a bifurcated stent graft is required in these cases. Modular stent grafts with separate main body and branch components are often preferred for these procedures due to their ease and precision of deployment. For an example of a modular stent graft with separate main body and branch components, see U.S. Patent Application Publication No. 2008 / 0114446 to Hartley et al. In the Hartley et al. publication, the main body stent has a window in its sidewall that is adapted to engage and secure a side-branch stent. A side-branch stent configured in this manner has a "wire-to-wire" interference fit with the main body window, potentially reducing the fatigue resistance of the stent-to-stent joint. U.S. Patent No. 6,645,242 to Quinn presents a more robust stent-to-stent connection configuration. In Quinn, a tubular support is incorporated inside the main body stent to improve the reliability of the connection between the stents. U.S. Patent No. 10,653,540 further expands on these concepts, featuring a highly adaptable stent graft with a portal for a side branch device. Summary of the Invention

[0005] Abstract Various examples relate to endovascular treatment systems that include branch features for perfusing branch vessels such as the renal arteries, superior mesenteric arteries, or others.

[0006] According to one example ("Example 1"), an endovascular treatment system includes a body component having a first end, a second end, and a lumen, the body including a first inner tube and a second inner tube disposed in the lumen, each of the first inner tube and the second inner tube having an origin toward the first end of the body component and an external opening on an outer surface of the body component, and a plurality of side branch components including a first side branch component and a second side branch component, each side branch component configured to be received in one of the first inner tube and the second inner tube and extend from the external opening on the outer surface of the body component, the system configured to be endovascularly implanted within an abdominal aorta to treat the abdominal aorta, the body component configured to be secured to the abdominal aorta at a position superior to the position of a patient's renal arteries, whereby the plurality of side branch components are securable to the patient's renal arteries for perfusion therethrough, and the body component including at least one of a window feature and a scallop feature configured to be aligned with the patient's superior mesenteric artery.

[0007] According to another example ("Example 2"), further to Example 1, the first inner tube and the second inner tube are circumferentially offset by approximately 180 degrees.

[0008] According to another example ("Example 3"), further to examples 1 or 2, the first inner tube and the second inner tube are circumferentially offset by approximately 160 degrees.

[0009] According to another example ("Example 4"), in addition to any of Examples 1 to 3, the first inner tube and the second inner tube are circumferentially offset by approximately 140 degrees.

[0010] According to another example ("Example 5"), further to any of Examples 1-4, the body component has a larger proximal inlet and two smaller distal outlets defined by two legs.

[0011] According to another example ("Example 6"), in addition to Example 5, the two legs include a short leg and a long leg.

[0012] According to another example ("Example 7"), in addition to any of Examples 1-4, the body component has a single larger proximal inlet and a single larger distal outlet.

[0013] According to another example ("Example 8"), in addition to any of Examples 1 to 7, the main body has an outer surface that protrudes radially outward in proximity to the external opening at a position corresponding to the outer shape of each internal tube, thereby orienting the external opening in the longitudinal direction.

[0014] According to another example ("Example 9"), in addition to any of Examples 1 to 8, the starting points of each of the first inner tube and the second inner tube are directed toward a first end of the main body and are longitudinally aligned with the inner lumen of the main body, and further, the external openings of each of the first inner tube and the second inner tube are longitudinally aligned with the inner lumen.

[0015] According to another example ("Example 10"), in addition to any of Examples 1 to 8, the body has an outer surface, and further, the external openings of the first inner tube and the second inner tube are flush with the outer surface of the body such that the external openings are radially oriented.

[0016] According to another example ("Example 11"), in addition to any of Examples 1 to 7 or Example 10, the origins of each of the first inner tube and the second inner tube are directed toward a first end of the body and are longitudinally aligned with the inner lumen of the body, and further, the external openings of each of the first inner tube and the second inner tube extend transversely to the inner lumen.

[0017] According to another example ("Example 12"), in addition to any of Examples 1 to 11, the starting point of at least one of the first inner tube and the second inner tube is inserted by an insertion distance from the first end of the main body.

[0018] According to another example ("Example 13"), in addition to any one of Examples 1 to 12, the insertion distance is 5 mm to 10 mm.

[0019] According to another example ("Example 14"), in addition to any of Examples 1 to 13, the external opening of at least one of the first inner tube and the second inner tube is offset from the first end of the main body by an offset distance of 40 mm or less.

[0020] According to another example ("Example 15"), a method of delivering an endoprosthesis to a treatment site in a patient's vasculature includes delivering a body component having a first end, a second end, and a lumen to a position within the abdominal aorta such that the first end of the body is positioned at a position superior to the patient's renal arteries, the body including a first inner tube and a second inner tube positioned within the lumen, each of the first inner tube and the second inner tube having an origin directed toward the first end of the body component and an external opening on an outer surface of the body component. The method also includes aligning at least one of a window feature and a scallop feature of the body component with the patient's superior mesenteric artery. The method also includes delivering a plurality of side branch components, including a first side branch component within the first inner tube and a second side branch component within the second inner tube, such that the first side branch component and the second side branch component extend from respective external openings on the outer surface of the main body component, and securing a first end of the main body component above the renal arteries and securing the first side branch component and the second side branch component to the respective renal arteries for perfusion.

[0021] According to another example ("Example 16"), further to example 15, the first inner tube and the second inner tube of the body component are circumferentially offset by approximately 180 degrees.

[0022] According to another example ("Example 17"), in addition to examples 15 or 16, the first inner tube and the second inner tube are circumferentially offset by approximately 160 degrees.

[0023] According to another example ("Example 18"), in addition to examples 15 or 16, the first inner tube and the second inner tube are circumferentially offset by approximately 140 degrees.

[0024] According to another example ("Example 19"), in addition to any of Examples 15 to 18, the body component has a larger proximal inlet and two smaller distal outlets defined by two legs.

[0025] According to another example ("Example 20"), an endovascular treatment system includes a body component having a first end, a second end, and a lumen, the body including a first inner tube and a second inner tube disposed within the lumen, the first inner tube and the second inner tube each having an origin directed toward the first end of the body component and an external opening on an outer surface of the body component, the first inner tube and the second inner tube being circumferentially offset from each other by about 140 degrees to about 180 degrees, the body having an outer surface that protrudes radially outwardly adjacent the external opening at a position corresponding to an outer shape of each inner tube such that the external opening faces longitudinally. A plurality of side branch components include a first side branch component and a second side branch component, each configured to be received in one of the first inner tube and the second inner tube and extend from the external opening on the outer surface of the body component. The system is configured to be endovascularly implanted within the abdominal aorta to treat the abdominal aorta, the main body component being configured to be secured to the abdominal aorta at a location superior to the location of the patient's renal arteries, whereby a plurality of side branch components are securable for perfusion to the patient's renal arteries, and the main body component including at least one of a window feature and a scallop feature configured to be aligned with the patient's superior mesenteric artery.

[0026] The various examples are merely examples and should not be construed as limiting or narrowing the scope of the inventive concepts otherwise provided by this disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description should be regarded as illustrative and not restrictive in nature. [Brief explanation of the drawings]

[0027] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification, illustrating embodiments and, together with the description, serving to explain the principles of the present disclosure.

[0028] [Figure 1] FIG. 1 is an isometric view of an endovascular treatment system according to some embodiments.

[0029] [Figure 2] FIG. 2 is an isometric view of some of the body components of the system of FIG. 1 according to some embodiments.

[0030] [Figure 3] FIG. 3 is an end view of the body components of the system of FIG. 1 according to some embodiments.

[0031] [Figure 4] FIG. 4 is a cross-section of the body components of the system of FIG. 1 according to some embodiments.

[0032] [Figure 5] FIG. 5 is an enlarged view of a portion of the cross section of FIG. 4 according to some embodiments.

[0033] [Figure 6] 6 is a diagram of the main body component and side branch component of the system of FIG. 1 implanted in a patient's abdominal aorta, with the side branch component received in the patient's renal arteries, according to some embodiments.

[0034] [Figure 7] FIG. 7 is an isometric view of another endovascular treatment system, according to some embodiments.

[0035] [Figure 8] FIG. 8 is an isometric view of the body components of the system of FIG. 7 according to some embodiments. [Figure 9] FIG. 9 is an isometric view of the body components of the system of FIG. 7 according to some embodiments.

[0036] [Figure 10] FIG. 10 is an end view of the body components of the system of FIG. 7 according to some embodiments.

[0037] [Figure 11] FIG. 11 illustrates a scallop design that may be employed in the body components of FIGS. 1 and 7 according to some embodiments.

[0038] [Figure 12] FIG. 12 shows additional views of the body components of FIG. 1 according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0039] Detailed Description Definitions and Terminology The present disclosure is not intended to be construed in a limiting sense, and for example, the terms used in this application should be interpreted broadly in accordance with the meaning that one of ordinary skill in the art would assign to such terms.

[0040] With respect to terms related to imprecision, the terms "about" and "approximately" may be used interchangeably to refer to measurements that include the stated measurement and measurements that are reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, as understood and easily ascertained by one of ordinary skill in the relevant art. Such deviations may result from, for example, measurement error, differences in calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, slight adjustments made to optimize performance and / or structural parameters to account for variations in measurements associated with other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, and / or the like. In cases where it is determined that the value of such relatively small differences would not be readily ascertained by one of ordinary skill in the relevant art, the terms "about" and "approximately" shall be understood to mean plus or minus 10% of the stated value.

[0041] Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0042] overview The various designs discussed in this patent specification relate to an endovascular treatment system 100 that includes a main body component 102 and multiple side branch components 104, including a first side branch component 104a and a second side branch component 104b, although more or fewer side branch components are contemplated. In various examples, the system 100 is used to treat an aortic aneurysm. Generally speaking, the system 100 is configured to help direct blood through the aorta while protecting the aortic wall from additional pressure from the blood flow. In other words, the system 100 functions to direct blood flow in a way that relieves pressure on damaged, weakened, or diseased portions of the vascular system, such as the aorta.

[0043] System 100 is configured to be endovascularly implanted within the abdominal aorta (e.g., using a catheter delivery system (not shown)) to treat the abdominal aorta. As described in more detail below (see also FIG. 6 ), in various examples, body component 102 is configured to be anchored to the abdominal aorta at a location superior or proximal to where the renal arteries (RA) branch off from the aorta and includes branch features to allow perfusion of these renal arteries. In some examples, body component 102 does not extend beyond the superior mesenteric artery and / or the celiac trunk. In other embodiments, body component 102 is anchored at a location superior or proximal to the superior mesenteric artery and / or the celiac trunk and includes features to allow perfusion of one or both of these aortic branch vessels.

[0044] For example, as shown in Figure 1, body component 102 can be a distally bifurcated body component 102a with a larger proximal inlet and two distal outlets defined by two legs, such as a shorter leg and a longer leg. Alternatively, as shown in Figure 7, for example, body component 102 can be a body component 102b with a larger single proximal inlet and a larger single distal outlet without defining separate legs or branches at the distal end.

[0045] System 100 may include additional stent graft components coupled to main body component 102 as part of a modular stent graft solution (e.g., additional stent graft components secured to their proximal and / or distal ends to extend the entire treatment length upwardly within the aorta or downwardly within the aorta or one or more lower branches thereof (e.g., into the common iliac arteries)). For example, as shown in FIG. 1, system 100 may further include a contralateral leg component 110. The contralateral leg component 110 may be a stent graft telescopically coupled to a shorter leg of main body component 102a, also referred to as the contralateral leg, and configured to extend into one of the iliac arteries, with the other, longer leg of main body component 102a (e.g., also referred to as the ipsilateral leg) extending into the other of the iliac arteries. One example of a suitable contralateral leg component 110 is the contralateral leg component sold as part of the GORE® EXCLUDER® AAA Endoprosthesis System, available from WL Gore & Associates, Inc.

[0046] 7, system 100 can include an additional branch component 200 configured to be telescopically coupled to the distal, or lower, end of body component 102b. Branch component 210 can include a shorter leg and a longer leg, where the longer leg (e.g., referred to as the ipsilateral leg) is configured to extend into one iliac artery and the shorter leg is configured to couple to contralateral leg component 210 configured to extend into the other iliac artery. An example of a suitable branch component 200 and contralateral leg component 210 is the GORE® EXCLUDER® Iliac Branch Endoprosthesis System available from W.L. Gore & Associates, Inc.

[0047] Each side branch component 104 is secured to the body component 102 at one of a plurality of portal features located intermediate the proximal and distal ends of the body component 102. In various examples, the side branch components 104 serve to perfuse branch vessels that may be occluded by implanting the system 100 to treat an aneurysm. For example, the side branch components 104 may be configured to extend from the body component 102 to the renal arteries to help promote continued perfusion of the kidneys and / or other organs. As described in more detail below, in various examples, the body component 102 (including 102a, 102b) is configured to be secured to or extend superiorly or proximally beyond the renal arteries and includes branch features that enable perfusion of the renal arteries.

[0048] The body component 102, side branch component 104, and other components (e.g., leg component 110 and branch component 200) are each comprised of graft components supported by stent or frame components. These graft and frame components can be made from a variety of materials and methods of manufacture, including examples described below.

[0049] Body design 1-6 illustrate various embodiments of a body component 102a according to a first design configuration. As shown, the body component 102a has a first end 120, also referred to as the proximal end, a second end 122, also referred to as the distal end, an outer surface 124, an inner surface 126, and a main lumen 128. The body component 102a has a proximal portion 130 toward the first end and a distal portion 131 that branches into a first leg 132 that is shorter than the first leg 132 and a second leg 134 that is longer than the first leg 132. The main lumen branches into the first leg 132 and the second leg 134 at the distal portion 131.

[0050] The proximal portion 130 of the body component 102a is generally configured to be anchored at a location in a patient's anatomy above where the renal arteries bifurcate from the aorta. The proximal portion 130 can include a tissue anchor for grasping the aortic vascular tissue to reduce the risk of migration from the anchor location. As shown, the proximal portion 130 of the body component 102a includes multiple inner tubes 152, including a first inner tube 152a and a second inner tube 152b that define portal features to which the branch component 104 can be anchored. Each inner tube 152 has an entrance or origin 160 located within the main lumen 128 and terminates at an external opening 162 on the outer surface 124 of the body component 102a. The external opening 162 can be surrounded or bounded by one or more stent or frame elements (e.g., one of the undulations or apexes), which can serve to define the lower edge and / or sides of the external opening 162. As shown, the external opening 162 is flush with the exterior surface 124. Also as shown, the origin 160 is directed toward the first end 120 and is generally aligned longitudinally with the main lumen 128. The external opening 162 then extends substantially transversely or perpendicularly to the main lumen 128. The inner tube 150 generally extends longitudinally of the main lumen 128.

[0051] The inner tube 152 generally defines a portal or gate for securing a side branch endoprosthesis and directing flow from the body component 102a to one or more branch vessels, such as the renal arteries. Although two inner tubes are shown, any number is contemplated and the illustrated embodiment is provided as an example.

[0052] The inner tubes 152 (also referred to as branch tubes) are optionally created by adding additional graft material formed into a tubular shape and bonding (e.g., suturing and / or gluing) it to the inside of the main body component (typically the graft component). Each inner tube 152 is optionally supported by a framework or stent component. The inner tubes 152 are sized to engage and secure with one of the side branch components 104 (shown schematically in dashed lines in FIG. 1 ) and to protrude from an exterior opening 162 into the side branch vessel.

[0053] As shown in FIG. 3, the inner tube 152 is positioned at a relative angular position or clockwise on the inner circumference of the body component 102a. FIG. 3 illustrates a medial-lateral ML and anterior-posterior AP coordinate system passing through the longitudinal centerline of the body component 102a. The first and second inner tubes 152a, 152b can be positioned clockwise on the medial-lateral axis or offset therefrom. In such an example, the first and second inner tubes 152a, 152b are offset from each other by approximately 180 degrees ±20 degrees. In some examples, the first and second inner tubes 152a, 152b are offset anteriorly from the medial-lateral axis by, for example, 5 degrees, 10 degrees, 15 degrees, 20 degrees, or other offsets as desired. As shown, the origins 160 are longitudinally aligned or substantially longitudinally aligned, but may be offset from each other as desired. In some examples, the origin 160 is recessed from the first end 120 of the body component 102a, for example, by 5 mm to 10 mm, although various offsets are contemplated. In various examples, the exterior opening 162 is offset from the first end 120 of the body 102a, for example, by 40 mm or less, although various offsets are contemplated.

[0054] 4 and 5 are cross-sections of the proximal portion 130 at a location between the origin 160 and the exterior opening of the inner tube 152. As shown, the inner tube 152 defines a secondary lumen 170 between an innermost graft layer 172 and an outermost graft layer 174. The inner tube 152 includes a secondary framework or stent 176. The inner tube 152 can include additional features, such as radiopaque markers.

[0055] Examples of suitable inner tube constructions for inner tube 152 can also be found in US Pat. No. 10,653,540 to Hagaman et al. and US Pat. No. 6,645,242 to Quinn.

[0056] 7-10 illustrate various aspects of a body component 102b according to a second design configuration. As shown, the body component 102b has a first end 220, also referred to as the proximal end, a second end 222, also referred to as the distal end, an outer surface 224, an inner surface 226, and a main lumen 228 (FIGS. 9 and 10). The body component 102b has a proximal portion 230 toward the first end and a distal portion 231 that tapers to a narrower diameter from the proximal portion 230.

[0057] The proximal portion 230 of the body component 102b is generally configured to be anchored at a location in the patient's anatomy above where the renal arteries bifurcate from the aorta. The proximal portion 230 can include a tissue anchor for grasping vascular tissue of the aorta to reduce the risk of migration from the anchor location. As shown in FIG. 10 , the proximal portion 230 of the body component 102b includes multiple inner tubes 252, including a first inner tube 252a and a second inner tube 252b, that define portal features to which the branch component 104 can be anchored. As shown in FIG. 10 , each inner tube 252 has an entrance or origin 260 located within the main lumen 228 and terminates at an external opening 262 ( FIG. 9 ) on the outer surface 224 of the body component 102b. The origins 260 are directed toward the first end 220 and are generally longitudinally aligned with the main lumen 228. The exterior opening 262 is substantially parallel to or aligned with the main lumen 228. As shown, the interior tube 250 extends generally longitudinally of the main lumen 228.

[0058] The inner tube 252 generally defines a portal or gate to which a side branch endoprosthesis may be attached to direct flow from the body component 102b to one or more branch vessels, such as the renal arteries. While two inner tubes are shown, any number is contemplated, and the illustrated embodiment is provided by way of example. As shown, the outer surface 224 is enlarged, raised, or otherwise protrudes radially outward to define the contour of the inner tube 252 toward the external opening 262.

[0059] Similar to inner tube 152, inner tube 252 (also referred to as branch tube) is optionally created by adding additional graft material formed into a tubular shape and bonding (e.g., suturing and / or gluing) it to the inside of a main body (typically a graft component). Each inner tube 252 is optionally supported by a framework or stent component. Inner tube 252 is sized to engage and secure with one of side branch components 104 (shown schematically in dashed lines in FIGS. 7 and 8 ) so as to protrude from exterior opening 262 into the side branch vessel.

[0060] As shown in FIG. 10 , the inner tube 252 is positioned at a relative angular position on the inner circumference of the body component 102b, or clockwise. FIG. 10 shows a medial-lateral ML and anterior-posterior AP coordinate system passing through the longitudinal centerline of the body component 102b. The first and second inner tubes 252a, b can be positioned clockwise on the medial-lateral axis or offset therefrom. In such an example, the first and second inner tubes 252a, b are offset from each other by approximately 180 degrees ± 20 degrees. In some examples, the first and second inner tubes 252a, b are each offset anteriorly from the medial-lateral axis, for example, by 5 degrees, 10 degrees, 15 degrees, 20 degrees, or other offsets as desired. As shown, the origins 260 are longitudinally aligned or substantially longitudinally aligned, but can be offset from each other as desired. In some examples, origin 260 is offset inward from first end 220 of body component 102b, for example, 5 mm to 10 mm, although various offsets are contemplated. In various examples, exterior opening 262 is offset from first end 220 of body component 102b, for example, 40 mm or less, although various offsets are contemplated.

[0061] 4 and 5 generally show schematic cross-sections of proximal portion 230 at a location between origin 260 and the exterior opening of inner tube 252. Suitable examples of inner tube structures for inner tube 252 are also described in U.S. Patent No. 10,653,540 to Hagaman et al. and U.S. Patent No. 6,645,242 to Quinn.

[0062] Window formation design As shown by dashed lines in the various figures, the body component 102 (including exemplary body components 102a, 102b) can include one or more window features 300. The one or more window features 300 can be disposed between two or more stents, framework rings, or turns. The one or more window features 300 can be pre-fenestrated or fenestrated. In other words, the graft component of the body component 102 can be removed to leave a void (pre-fenestrated), or the graft component can be configured to be removable to create a void (e.g., by resecting, cutting, puncturing, or otherwise opening to form one or more window features 300). The one or more window features 300 can include frame member support (e.g., a ring of material similar to the stent member) and can be radiopaque, if desired. In other examples, the one or more window features 300 are not supported by a frame member and can be radiopaque (or bordered by a radiopaque material), if desired. One or more window features 300 can be positioned to align with a side branch vessel, such as the superior mesenteric artery, to facilitate perfusion thereof. Additionally or alternatively, one or more window features 300 can receive a side branch component or other feature.

[0063] Scallop design In some embodiments, the body component 102 can include one or more scallop features 400 at a first end (e.g., first end 120, 220), as shown by the dashed border in the various figures. The scallop feature 400 can be implemented to facilitate placement of the body component 102 in a lumen containing a side branch vessel that does not require deployment of an artificial side branch. For example, when the body component 102 is positioned in the abdominal aorta and the superior mesenteric artery does not require deployment of a side branch 14 therein, the scallop feature 400 can be positioned over the ostium of the superior mesenteric artery without blocking or restricting blood perfusion of the superior mesenteric artery. The scallop feature 400 can include a variety of shapes, including straight-edged shapes, curved shapes, and combinations thereof. One generally trapezoidal void in the graft component is shown by dashed lines as an example. As shown, a stent component optionally extends over the void, although embodiments are contemplated in which the stent component is removed or molded into the scallop feature 400, for example. Similar to the window feature, the scallop feature 400 can include radiopaque material, for example, to indicate its edge or boundary.

[0064] Figure 11 shows one example design of the scallop feature 400. As shown in Figure 11, the scallop feature 400 is located at the proximal end 120, 200 and is defined by a void within the graft component forming the body 102. As shown, the stent component extends over the scallop feature 400. In this manner, the stent component still provides support and anchoring functions to the body 102 while allowing blood flow to pass through the scallop feature 400 for perfusion purposes (e.g., to perfuse a patient's superior mesenteric artery).

[0065] Branched graft design The side branch component 104 can take a variety of forms, including self-expanding and balloon-expandable stent-graft configurations. Generally, the side branch component 104 is received within one of the inner tubes 150 and is sized and shaped to extend into the desired side branch vessel, such as the renal arteries. One example of a suitable side branch component is the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, available from WL Gore & Associates, Inc. Another suitable example is the GORE® VIABAHN® Endoprosthesis (Self-Expanding), available from WL Gore & Associates, Inc.

[0066] material The materials used for the graft components relative to the main body and branch components can include any material suitable for use as a graft in a selected body lumen. The main body and branch(es) graft components can be constructed from the same or different materials. The graft components can include multiple layers of material, which can be the same or different materials. The graft component can have multiple layers of material, but can have a tubularly formed layer (the innermost tube) and an outermost tubularly formed layer (the outermost tube).

[0067] Many graft materials are known, particularly those that can be used as vascular graft materials. The graft materials can be extruded, coated, or formed from wrapped films, or combinations thereof.

[0068] Polymers, biodegradable materials, and natural materials can be used for certain applications. Biocompatible materials are particularly contemplated for the various graft components associated with the body and branch components described herein. In certain examples, the graft components can include fluoropolymers such as polytetrafluoroethylene (PTFE) polymer or expanded polytetrafluoroethylene (ePTFE) polymer. In some examples, the graft components can be formed from materials such as, but not limited to, polyester, silicone, urethane, polyethylene terephthalate, or other biocompatible polymers, or combinations thereof. In some examples, bioresorbable or bioabsorbable materials can be used, such as bioresorbable or bioabsorbable polymers. In some examples, the graft can include Dacron, polyolefin, carboxymethylcellulose fabric, polyurethane, or other woven, nonwoven, or film elastomers.

[0069] Biocompatible materials can be used for the various frame or stent components associated with the body and branch components described herein. For example, nitinol (NiTi) can be used as the frame or stent (and any frame described herein) material, although other materials, including but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or other suitable biocompatible materials, and combinations thereof, can be used as the frame material. The superelastic properties and flexibility of NiTi can improve the conformability of the stent. Furthermore, NiTi can be shape-set to a desired shape. That is, NiTi can be shape-set so that the frame tends to self-expand into a desired shape when unconstrained, e.g., when the frame is deployed from a delivery system.

[0070] Note The invention of the present application has been described above generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the present disclosure. Therefore, it is intended that the embodiments cover the modifications and variations of the present invention provided they fall within the scope of the appended claims and their equivalents.

Claims

1. a body component having a first end, a second end, and an internal lumen, the body including a first internal tube and a second internal tube disposed in the internal lumen, the first internal tube and the second internal tube each having an origin directed toward the first end of the body component and an external opening on an outer surface of the body component; a plurality of side branch components including a first side branch component and a second side branch component, each side branch component configured to be received in one of the first inner tube and the second inner tube and to extend from an external opening in the outer surface of the body component; An endovascular treatment system comprising:

1. The endovascular treatment system of claim 1, wherein the system is configured to be endovascularly implanted within the abdominal aorta to treat the abdominal aorta, the main body component is configured to be secured to the abdominal aorta at a position superior to the position of the patient's renal arteries, whereby the plurality of side branch components are securable to the patient's renal arteries for perfusion thereof, and the main body component includes at least one of a window feature and a scallop feature configured to be aligned with the patient's superior mesenteric artery.

2. The system of claim 1 , wherein the first inner tube and the second inner tube are circumferentially offset by approximately 180 degrees.

3. 3. The system of claim 1, wherein the first inner tube and the second inner tube are circumferentially offset by approximately 160 degrees.

4. The system of any one of claims 1 to 3, wherein the first inner tube and the second inner tube are circumferentially offset by approximately 140 degrees.

5. The system of any one of claims 1 to 4, wherein the body component has a larger proximal inlet and two smaller distal outlets defined by two legs.

6. The system of claim 5 , wherein the two legs include a short leg and a long leg.

7. The system of any one of claims 1 to 4, wherein the body component has a single larger proximal inlet and a single larger distal outlet.

8. The system of any one of claims 1 to 7, wherein the main body has an outer surface that protrudes radially outward adjacent the external opening at a position corresponding to the outer shape of each internal tube, thereby orienting the external opening in a longitudinal direction.

9. The system of any one of claims 1 to 8, wherein the respective origins of the first inner tube and the second inner tube are directed toward a first end of the body and are longitudinally aligned with the inner lumen of the body, and further, the respective external openings of the first inner tube and the second inner tube are longitudinally aligned with the inner lumen.

10. 9. The system of claim 1, wherein the body has an outer surface, and further wherein the outer openings of the first inner tube and the second inner tube are flush with the outer surface of the body such that the outer openings are radially oriented.

11. The system of any one of claims 1 to 7 or 10, wherein the origins of the first inner tube and the second inner tube are directed toward a first end of the body and are longitudinally aligned with the lumen of the body, and further wherein the external openings of the first inner tube and the second inner tube extend transversely to the lumen.

12. The system of any one of claims 1 to 11, wherein an origin of at least one of the first inner tube and the second inner tube is inserted from the first end of the body by an insertion distance.

13. The system according to any one of claims 1 to 12, wherein the insertion distance is between 5 mm and 10 mm.

14. The system of any one of claims 1 to 13, wherein the external opening of at least one of the first inner tube and the second inner tube is offset from the first end of the body by an offset distance of 40 mm or less.

15. 1. A method of delivering an endoprosthesis to a treatment site in a patient's vasculature, the method comprising: delivering a body component having a first end, a second end, and a lumen to a position within the patient's abdominal aorta such that the first end of the body is positioned above the renal arteries, the body including a first inner tube and a second inner tube positioned within the lumen, each of the first inner tube and the second inner tube having an origin directed toward the first end of the body component and an external opening on an outer surface of the body component; aligning at least one of a window feature and a scallop feature of the body component with the patient's superior mesenteric artery; delivering a plurality of side branch components, including a first side branch component within the first inner tube and a second side branch component within the second inner tube, such that the first side branch component and the second side branch component extend from respective external openings in the outer surface of the body component; and securing a first end of the body component above the renal arteries and securing the first and second side branch components to each of the renal arteries for perfusion; A method comprising:

16. The method of claim 15 , wherein the first inner tube and the second inner tube of the body component are circumferentially offset by approximately 180 degrees.

17. 17. The method of claim 15 or 16, wherein the first inner tube and the second inner tube are circumferentially offset by approximately 160 degrees.

18. 17. The method of claim 15 or 16, wherein the first inner tube and the second inner tube are circumferentially offset by approximately 140 degrees.

19. The method of any one of claims 15 to 18, wherein the body component has a larger proximal inlet and two smaller distal outlets defined by two legs.

20. a body component having a first end, a second end, and an internal lumen, the body including a first internal tube and a second internal tube disposed within the internal lumen, the first internal tube and the second internal tube each having an origin directed toward the first end of the body component and an external opening on an outer surface of the body component, the first internal tube and the second internal tube being circumferentially offset from one another by about 140 degrees to about 180 degrees, the body component having an outer surface that protrudes radially outward adjacent the external opening at a location corresponding to the outer shape of each internal tube such that the external opening faces longitudinally; a plurality of side branch components, including a first side branch component and a second side branch component, each configured to be received in one of the first inner tube and the second inner tube and to extend from an external opening in the outer surface of the body component; An endovascular treatment system comprising: The system is configured to be endovascularly implanted within the abdominal aorta to treat the abdominal aorta, the main body component is configured to be secured to the abdominal aorta at a position superior to the position of the patient's renal arteries, whereby the plurality of side branch components are securable for perfusion to the patient's renal arteries, and the main body component includes at least one of a window feature and a scallop feature configured to be aligned with the patient's superior mesenteric artery.

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