Multi-branch endovascular devices and methods

Abstract

To provide good devices and the like.SOLUTION: A multibranch implantable device is provided, including: a main body including a tubular element having wall defining a main lumen, the tubular element having a first end defining a first opening into the main lumen and a second end defining a second opening into the main lumen, the tubular element including at least one side branch portal defining an aperture through the wall between the first longitudinal end and the second longitudinal end of the tubular element and at least one secondary body defining a secondary lumen, the at least one secondary body operable to be deployed with a portion of the secondary body positioned in the at least one side branch portal of the main body.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of International Application No. PCT / US2021 / 061379, filed December 1, 2021, which is incorporated by reference in its entirety for all purposes.

[0002] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to intraluminal devices having multiple branches, and associated systems and methods. More particularly, the present disclosure relates to intraluminal devices configured to be implemented within branched anatomical passageways. [Background technology]

[0003] background A variety of branched anatomical passageways can benefit from treatment in the form of an implanted intraluminal device. One such passageway is a vascular passageway, such as an aneurysmal artery. Aneurysms develop in blood vessels at locations where, due to a patient's age, disease, or genetic predisposition, the strength or elasticity of the vessel wall is insufficient to prevent the wall from expanding 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.

[0004] To prevent aneurysm rupture, a stent graft can be percutaneously introduced into the vessel and deployed to span the aneurysmal sac. Various stent grafts include a graft fabric secured to a tubular scaffold or framework of one or more stents. In general, the stent not only provides the rigidity and structure to hold the graft open in a tubular configuration, but also provides the outward radial force necessary to form a seal between the graft and a healthy portion of the vessel wall and provide transition resistance. Blood flowing through the vessel flows through the luminal surface of the stent graft, which can reduce, if not eliminate, the stress on the vessel wall at the location of the aneurysmal sac. The stent graft can reduce the risk of vessel wall rupture at the aneurysm site and allow blood to flow through the vessel uninterrupted.

[0005] However, various endovascular repair procedures, such as aneurysm removal, require a stent graft to be implanted adjacent to a vessel bifurcation. Often, the aneurysm extends to the bifurcation, requiring a stent graft to be placed at the bifurcation. Thus, a bifurcated stent graft is required in such cases. Modular stent grafts with separate main body and branch components are often preferred in these procedures due to ease and accuracy of deployment. See U.S. Patent Application Publication No. 2008 / 0114446 to Hartley et al. for an example of a modular stent graft with separate main body and branch stent components. In the Hartley et al. publication, the main body stent has fenestrations in its sidewall that are adapted to engage and secure with the side branch stent. The side branch stent in such a configuration is in a "line-to-line" interference fit with the main body fenestrations, which may compromise the fatigue resistance of the stent-to-stent interface. U.S. Patent No. 6,645,242 to Quinn shows a more robust stent-to-stent interface configuration. In Quinn, a tubular support is incorporated inside the main body stent to improve the reliability of the stent-to-stent connection. Quinn's tubular internal support improves fatigue resistance and extends seal length. Summary of the Invention

[0006] Abstract An endoprosthesis including a main body is provided with a side branch portal for providing fluid access to a side branch of the main lumen when the main body of the endoprosthesis is deployed within the main lumen.

[0007] According to one example ("Example 1"), a multi-branched implantable device includes a main body including a tubular element having a wall defining a main lumen, the tubular element having a first end defining a first opening into the main lumen and a second end defining a second opening into the main lumen, the tubular element including at least one side branch portal defining an aperture through a wall between the first longitudinal end and the second longitudinal end of the tubular element, and at least one secondary body defining a secondary lumen, the at least one secondary body being operable to be deployed with a portion of the secondary body disposed within the at least one side branch portal of the main body.

[0008] According to another example ("Example 2"), in the multi-branch device of Example 1, at least one side branch portal has a first end and a second end, and the secondary body is operable to be deployed such that the second end of the side branch portal is substantially continuous with an outer surface of the main body.

[0009] According to another example ("Example 3"), in any of the multi-branched devices of the above examples, when the main body is in a neutral, unbent configuration, a first opening in a first longitudinal end of the tubular element faces a first direction and a second end of the at least one side branch portal faces substantially in the first direction.

[0010] According to another example ("Example 4"), in the multi-branch device of either Example 1 or Example 2, when the main body is in a neutral, unbent configuration, a second opening in a second longitudinal end of the tubular element faces a second direction and a second end of the at least one side branch portal faces substantially in the second direction.

[0011] According to another example ("Example 5"), in the multi-branch device of any of the previous examples, the main body wall defines a recess adjacent at least one side branch portal.

[0012] According to another example ("Example 6"), in the multi-branched device of any of the previous examples, the main body further includes a stent coupled to the wall.

[0013] According to another example ("Example 7"), in the multi-branched device of any of the previous examples, the portion of the wall defining the recess is unsupported.

[0014] According to another example ("Example 8"), in a multi-branch device of any of the above examples, the at least one side branch portal includes a first portal, a second portal, and a third portal, each having an external opening disposed at a first longitudinal position along the main body.

[0015] According to another example ("Example 9"), in the multi-branch device of any one of Examples 1 to 7, the at least one side branch portal includes a first portal, a second portal, and a third portal, each having an external opening disposed at one of at least two longitudinal positions along the main body.

[0016] According to another example ("Example 10"), a method of deploying an endoprosthesis at a target site having a main lumen and a first branch lumen includes advancing a main body of a multi-branch stent graft toward a main lumen of a target site, wherein the main body has a first portion and a second portion, the main body defining a first portal operable to provide fluid access from the main body to a first side branch extending from the target site when the main body is deployed at the target site, partially deploying the first portion of the main body within the main lumen of the target site, advancing a first articulatable wire into the first branch lumen through the first portal, partially deploying the second portion of the main body within the main lumen of the target site, fully deploying the first and second portions of the main body, advancing a first side branch body along the first articulatable wire into the first branch lumen of the target site, and deploying the first side branch body within the first branch lumen of the target site.

[0017] According to another example ("Example 11"), in the method of Example 10, the first portal has a first end and a second end, the second end being substantially continuous with an outer surface of the main body.

[0018] According to another example ("Example 12"), in the method of either Example 10 or 11, the main body defines a main body longitudinal axis, the first portal defines a first portal longitudinal axis, and the main body longitudinal axis and the first portal longitudinal axis are substantially parallel.

[0019] According to another example ("Example 13"), in any one of the methods of Examples 10-12, the first portal is positioned such that the first portal from the first end to the second end is counter-current to fluid flow through the main body.

[0020] According to another example ("Example 14"), in the method of any one of Examples 10-13, the wall of the main body defines a recess adjacent the first portal such that when the first articulatable wire and first side branch body are advanced, the recess provides clearance for the first articulatable wire and first side branch body to exit the first portal without kinking.

[0021] According to another example ("Example 15"), in the method of any of claims 10-14, the main body includes a stent coupled to the wall, and the portion of the wall defining the recess does not include a stent.

[0022] According to another example ("Example 16"), in the method of Example 10, the main body includes a second portal and a third portal, and includes advancing a second articulatable wire through the second portal and into the second branch lumen of the target site, advancing a third articulatable wire through the third portal and into the third branch lumen of the target site, advancing a second side branch body along the second articulatable wire into the second branch lumen of the target site, and advancing a third side branch body along the third articulatable wire into the third branch lumen of the target site.

[0023] According to another example ("Example 17"), in the method of Example 16, the first side branch body is deployed prior to deploying the second side branch body and the third side branch body.

[0024] According to another example ("Example 18"), in the method of either Example 16 or Example 17, the external openings of each of the first portal, the second portal, and the third portal are each positioned at a first longitudinal position along the main body.

[0025] According to another example ("Example 19"), in the method of either Example 16 or Example 17, each of the external openings of the first portal, the second portal, and the third portal has an external opening disposed at one of at least two longitudinal positions along the main body.

[0026] According to another example ("Example 20"), the method of Examples 10-19 further includes adjusting an internal curvature of the main body prior to fully deploying the first portion and the second portion of the main body.

[0027] According to another example ("Example 11"), in the method of Example 16, each of the side branch bodies are deployed substantially simultaneously.

[0028] The foregoing 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 several 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 are to be regarded as illustrative in nature and not as restrictive in nature. [Brief description of the drawings]

[0029] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the disclosure.

[0030] [Figure 1] FIG. 1 is a side view of an implantable device with a main body and a side branch, according to one embodiment.

[0031] [Diagram 2] FIG. 2 is a side view of an implantable device deployed within a patient's aortic arch, according to one embodiment.

[0032] [Diagram 3] FIG. 3 is a top view of the main body of an implantable device, including a side branch portal through which a side branch member can be delivered and deployed, according to one embodiment.

[0033] [Figure 4] FIG. 4 is a side view of the main body of an implantable device, according to one embodiment, including a portal access mechanism to provide clearance for a side branch member delivered and deployed through the side branch portal.

[0034] [Diagram 5] FIG. 5 is an end view of the main body of an implantable device, according to one embodiment, with the internal opening of the side branch portal located within the lumen of the main body.

[0035] [Figure 6] FIG. 6 is an end view of the main body of an implantable device with a portal access mechanism protruding into the lumen of the main body, according to one embodiment.

[0036] [Figure 7] FIG. 7 is a top view of the main body of an implantable device, where the main body includes a stent structure that extends beyond the side branch portal, according to one embodiment.

[0037] [Figure 8] FIG. 8 is a perspective view of a main body including side branch portals offset along the longitudinal length of the main body according to one embodiment.

[0038] [Figure 9] FIG. 9 is a perspective view of a main body including two side branch portals aligned along the longitudinal length of the main body and offset relative to the side branch portals according to one embodiment.

[0039] [Figure 10]FIG. 10 is a top view of a main body including a side branch having a stent structure extending across a portal access feature, according to one embodiment.

[0040] [Figure 11] FIG. 11 is a perspective view of a main body including a portal access mechanism according to one embodiment.

[0041] [Figure 12] FIG. 12 is a side view of a main body including a portal access mechanism according to one embodiment.

[0042] [Figure 13] FIG. 13 is an end view of a main body including a cartridge having a side branch portal, the cartridge being deployable within a pocket of the main body, according to one embodiment.

[0043] [Figure 14] FIG. 14 is an end view of a cartridge deployed within a pocket of a main body, according to one embodiment.

[0044] [Figure 15] FIG. 15 is a top view of a main body with a portal access mechanism supported by a portal access stent structure separate from the stent structure of the main body, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a limiting sense, for example, the terms used in this application should be read broadly in the context of the meanings that experts in the field would ascribe to such terms.

[0046] Those skilled in the art will readily appreciate that the various aspects of the present disclosure can be implemented by any number of methods and devices configured to perform the intended functions. In other words, other methods and devices can be incorporated herein to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that respect, the drawings should not be construed as limiting.

[0047] Certain relative terms are used to indicate the relative positions of components and features. For example, words such as "top," "bottom," "upper," "lower," "left," "right," "horizontal," "vertical," "upward," "downward," and the like are used in a relative sense (such as how the components and features are positioned relative to one another) and not in an absolute sense, unless the context dictates otherwise. Similarly, throughout this disclosure, when processes or methods are illustrated or described, the methods may be performed in any order or simultaneously, unless it is clear from the context that the method is dependent on a particular operation being performed first.

[0048] With respect to the term imprecision, the terms "about" and "approximately" may be used in certain cases to refer to measurements that include and are reasonably close to the stated measurements. Measurements that are reasonably close to the stated measurements deviate from the stated measurements by a reasonably small amount, as would be understood and readily ascertained by one of ordinary skill in the relevant art. Such deviations may result from measurement errors, differences in calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, fine-tuning made to optimize performance and / or structural parameters given differences in measurements associated with other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, and the like.

[0049] As used herein, "couple" means to connect, connect, attach, adhere, affix or bond, whether directly or indirectly and permanently or temporarily.

[0050] As used herein, the term "elastomer" refers to a polymer or mixture of polymers that has the ability to stretch at least 1.3 times its original length and rapidly retract to nearly its original length upon release. The term "elastomeric material" refers to a polymer or mixture of polymers that exhibits similar stretch and recovery properties to elastomers, although not necessarily to the same extent. The term "non-elastomeric material" refers to a polymer or mixture of polymers that exhibits stretch and recovery properties that are not similar to either elastomers or elastomeric materials, i.e., are not considered to be elastomers or elastomeric materials as commonly known.

[0051] The term "film," as used herein, refers collectively to one or more of a membrane, composite, or laminate.

[0052] The term "biocompatible material," as used herein, generally refers to any material that has biocompatible properties, including, but not limited to, synthetic materials, such as biocompatible polymers, or biological materials, such as, but not limited to, bovine pericardium. The biocompatible material can include a first film and a second film, as described herein with respect to various embodiments.

[0053] For reference, the terms "circumference" and "diameter" are not intended to imply a circular cross-section (although they may include a circular cross-section), but should instead be broadly understood to refer to an exterior surface or dimension, or the dimension between opposing surfaces of an exterior surface.

[0054] The embodiments herein may be described in relation to various principles and beliefs, but the described embodiments should not be bound by theory. For example, the embodiments are described herein in relation to vascular stent grafts, and more specifically, bifurcated stent grafts. However, embodiments within the scope of the present disclosure may be applied to any endoprosthesis of similar structure and / or function. Additionally, embodiments within the scope of the present disclosure may be applied to non-vascular applications.

[0055] Description of Various Embodiments 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 devices 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.

[0056] Although device 10 shown in FIG. 1 is provided as an example of various device features, combinations of these illustrated features are clearly within the scope of the present invention, and the example and its illustration are not intended to suggest that the inventive concepts provided herein are limited by fewer features, additional features, or alternative features to one or more of those features shown in FIG. 1.

[0057] 1 and 2, there is shown a device 10 for treating disease along a main blood vessel 20 and at least one branch blood vessel 22 extending from the main blood vessel 20. The device 10 includes a main body 100 configured for deployment within the main blood vessel and having a main lumen. The device 10 also includes at least one branch member 200 having a branch lumen 202 for deployment within the at least one branch blood vessel.

[0058] Referring to FIG. 3, one embodiment of a body 100 is shown. The main body 100 includes a wall 104 that defines a main lumen 102. The main body 100 has a first end 106 and a second end 108. At the first end 106, the main body 100 includes a first opening 107, and at the second end 108, the main body 100 includes a second opening 109. Each of the openings 107, 109 provides access to the main lumen 102 at the corresponding end 106, 108. Fluid can flow through the main lumen 102 by entering the main lumen 102 through the first opening 107 and exiting the second opening 109, defining a main body fluid flow direction. Or, the flow can be in the opposite direction, defining a main body fluid flow direction. The outer wall 104 substantially forms or defines the outer profile of the main body 100.

[0059] In some embodiments, the main body 100 is formed from a stent structure 120 and a graft member 130. The stent structure 120 is operable to maintain patency of the main body 100 and / or the main vessel 20 when the main body 100 is deployed. The stent structure 120 can be formed from a variety of materials, including but not limited to metals, metal alloys, polymers, and any combination thereof, to provide elasticity or plasticity (e.g., a self-expanding or balloon expandable stent). The graft member 130 is coupled to the stent structure 120 to form a fluid impermeable or semi-permeable layer through which fluid (e.g., blood) can flow.

[0060] The main body 100 further includes at least one side branch portal 110. The side branch portal 110 is operable to provide fluid access between the main lumen 102 and the branch vessel. The side branch portal 110 forms or is disposed at an opening 112 through the wall 104 along the outer profile of the main body 100. Stated differently, the side branch portal 110 extends longitudinally through the wall 104 of the main body 100 between the first end 106 and the second end 108 of the main body 100. Thus, fluid can flow through the first opening 107 and through the side branch portal 110. Some embodiments include multiple side branch portals 110. For example, FIG. 3 shows that the main body 100 includes a first side branch portal 110a, a second side branch portal 110b, and a third side branch portal 110c. Any number of side branch portals 110 can be incorporated to accommodate the particular anatomy in which the device 10 is deployed.

[0061] 3, in some embodiments, each of the side branch portals 110 includes a side branch stent structure 114 and a side branch graft member 116. In various embodiments, the side branch stent structure 114 and the side branch graft member 116 may be separate from, incorporated into, or integral with the main body stent structure 120 and the main body graft member 140. For example, as shown in FIGS. 3-5, the side branch stent structure 114 is separate or separate from the main body stent structure 120, while the side branch graft member 116 is incorporated into the main body graft member 140 (e.g., sandwiched or interposed between layers of the main body graft member 140). In some embodiments, the side branch stent structure 114 extends from the main body stent structure 120 and thus represents a portion of the main body stent structure 120, rather than being an independent stent structure. In yet other embodiments, the side branch stent structure 114 is coupled to the main body stent structure 120. Similarly, the side branch graft member 116 may be formed directly from the main body graft member 140 and thus represent a portion of the main body graft. In other embodiments, the side branch graft member 116 is coupled to the main body graft member 140, or in yet other embodiments, is spaced apart from the main body graft member 140. It is understood that any combination of embodiments of the side branch stent structure 114 and the side branch graft member 116 are within the scope of the present disclosure.

[0062] In some embodiments, the side branch portal 110 is located between the first end 106 and the second end 108 of the main body 100 and does not extend beyond or increase the outer profile of the main body 100 (see FIGS. 4 and 5 ). Stated another way, a portion of the outer wall of the side branch portal 110 is disposed along the wall 104 of the main body 100 (e.g., flush with the outer profile) within the outer profile of the main body 100. Thus, the side branch portal 110 can extend into the main lumen 102 of the main body 100 without substantially increasing the outer profile of the main body 100 adjacent the exit location of the side branch portal 110 from the main body 100.

[0063] Each side branch portal 110 can include a first end 118 and a second end 122 that define a first opening 119 and a second opening 121, respectively. Fluid travels through the side branch portal from the first end 118 to the second end 122 (or vice versa), defining a side branch fluid flow direction. The side branch portals 110 are positioned such that the first opening 119 is disposed within or oriented toward the main lumen 102 of the main body 100, and the second opening 121 is disposed outside of or oriented away from the main body 100 (e.g., the first opening 119 is an internal opening of the side branch portal 110 relative to the wall 104 and main lumen 102 of the main body 100, and the second opening 121 is an external opening). For example, FIG. 5 illustrates an embodiment in which the first opening 119 of the side branch portal 110 is disposed within the main lumen 102. The side branch portals 110 can have various longitudinal lengths. Additionally, when multiple side branch portals 110 are implemented, one or more of the side branch portals 110 may have a different length than another side branch portal 110, or one or more of the side branch portals 110 may have the same length as another side branch portal 110. In embodiments implementing multiple side branch portals 110, each side branch portal 110 can have a unique diameter and / or geometric orifice area relative to the other side branch portals 110 (see FIG. 10 ).

[0064] In some embodiments, the side branch portal 110 is oriented such that the side branch fluid flow direction is opposite to the main body fluid flow direction (e.g., countercurrent to the main body fluid flow direction). It is understood that opposite or countercurrent in these embodiments is not limited to a difference of 180 degrees, but generally includes a change in fluid flow direction of more than 90 degrees. It is also understood that the fluid flow direction is relative to a particular location along the longitudinal length of the main body 100 when the main body 100 is conforming to a curved anatomy. For example, embodiments in which the side branch fluid flow direction is opposite or countercurrent to the main body fluid flow include embodiments in which the second opening 121 of the side branch portal 110 is longitudinally closer to the first end 106 of the main body 100 than the first opening 119 of the side branch portal 110. Orienting the side branch portal 110 in a retrograde direction allows the surgeon to perform the intervention and any subsequent interventions from a more advantageous access site (e.g., a femoral access site to reduce trauma to the carotid, subclavian, or other arteries, or to reduce surgical presence in a dense portion of the patient's anatomy, such as around the neck or chest when operating on the aortic arch). This orientation may be advantageous in some presentations where access from certain access sites may be difficult, obstructed, or dangerous.

[0065] In other embodiments, the side branch portal 110 is oriented such that the side branch fluid flow direction is generally oriented with the main body fluid flow direction (e.g., antegrade relative to the main body fluid flow direction). Embodiments in which the side branch fluid flow direction is antegrade relative to the main body fluid flow include embodiments in which the first opening 119 of the side branch portal 110 is longitudinally closer to the first end 106 of the main body 100 relative to the second opening 121 of the side branch portal 110. An antegrade orientation may be advantageous in some embodiments to maintain more traditional fluid flow, especially in tissues or anatomical structures that may have unique geometries that limit the use of a retrograde orientation. In embodiments implementing multiple side branch portals 110, the side branch portals may all have an antegrade orientation, all may have a retrograde orientation, or may include one or more branch portals with an antegrade orientation and one or more portals with a retrograde orientation.

[0066] The second opening 121 of the side branch portal 110 can be located at various longitudinal positions between the first end 106 and the second end 108 of the main body 100. For example, the second opening 121 of the side branch portal 110 can be located approximately at the midpoint of the first and second ends 106, 108 of the main body 100. In other embodiments, the second opening 121 of the side branch portal 110 can be located closer to the first end 106 relative to the second end 108, or closer to the second end 108 relative to the first end 106 of the main body 100. In embodiments including multiple side branch portals 110, each of the second openings 121 can be aligned longitudinally along the length of the main body 100 (see FIG. 3), offset along the length of the main body 100 (see FIG. 8), or a combination thereof (see FIG. 9).

[0067] The side branch portal 110 can be incorporated into the main body 100 in a variety of ways. For example, the side branch portal 110 may be wrapped between film layers of the graft member 130 (e.g., FIG. 11). Note that in embodiments where multiple side branch portals 110 are implemented, a plug (not shown) may be inserted into any one or more of the side branch portals 110 if one or more side branch portals are not required for a particular application. For example, the device 10 may include three side branch portals 110, but only two are needed for a patient (e.g., in the case of an aortic arch with a bypass), and one of the side branch portals 110 may be closed (e.g., by a plug).

[0068] In some embodiments, the stent structure 120 extends around the circumference of the side branch portal 110 (FIG. 7). In embodiments implementing a side branch stent structure 114, which may implement a less obtrusive material or may implement a material that provides less retention or expansion force than the main stent structure 120, the stent structure 120 may extend around the side branch portal 110 to limit collapse of the side branch portal 110 and the side branch stent structure 114 during delivery, deployment, and use of the device 10. However, in some embodiments, the stent structure 120 does not extend around the side branch portal 110 (see, e.g., FIG. 4).

[0069] 13 and 14, the main body 100 can form a pocket 180 into which the side branch portal 110 is inserted. For example, in some embodiments, the side branch portal 110 is incorporated into a cartridge 190. The cartridge 190 is a modular element that can be inserted into the pocket 180 of the main body 100. For example, the cartridge can implement one, two, three, four or any number of side branch portals for use with the main body 100. This allows the device 10 to be customized to the specific needs of the patient. In some embodiments, the cartridge 190 includes one or more side branch portals 110 that are bonded together (e.g., via a wrapping or film). The cartridge 190 provides access from outside the main body to the main lumen 102 at a location between the first end 106 and the second end 108 via the side branch portals 110. This provides a modular solution for customizing the device 10 with off-the-shelf components.

[0070] Referring now to FIG. 4, the main body 100 includes a portal access mechanism 150. The portal access mechanism 150 is operable to provide clearance for the branch member 200 to be deployed at least partially disposed within the side branch portal 110. For example, the portal access mechanism 150 can be a portion of the wall 104 of the main body 100 having a concave outer profile. For example, in FIG. 4, the main body 100 as shown includes a substantially circular cross-section along the longitudinal length of the main body 100, except for the longitudinal length of the main body 100 that defines the portal access mechanism 150. FIG. 6 shows the main body 100 from a side view looking through the main lumen 102. In this view, the substantially circular outer profile is shown. This view also shows the profile of the main body at the portal access mechanism 150. The main body 100 at the portal access mechanism 150 includes a substantially circular cross-section, with a truncated or chord portion 152 of the wall 104 extending from a first location 154 of the wall 104 to a second location 156 of the wall 104. As shown, the portal access mechanism 150 deviates from the typical outer profile of the remainder of the main body 100 such that the portal access mechanism 150 emerges radially inward from the remainder of the main body 100.

[0071] Referring again to FIG. 4 , the portal access mechanism 150 is defined in the wall 104 of the main body 100 from at least the second opening 121 of the side branch portal 110 toward the first end 106 of the main body. The depth 158 of the portal access mechanism 150 is substantially equal to the diameter of the side branch portal 110. The portal access mechanism 150 can extend a predetermined length 160 at the depth 158 from the second opening 121 of the side branch portal 110. The predetermined length 160 can provide sufficient space for the branch member 200 to exit the side branch portal 110 and rotate or bend toward the branch vessel 22, and defines the inlet portion 160 of the portal access mechanism 150. The inlet portion 160 in some embodiments is substantially flat, as shown in FIGS. 4 and 10 . However, in some embodiments, the inlet portion 160 can incorporate a curvature. For example, in some embodiments, the inlet portion 160 includes an arcuate profile. The arcuate profile allows for multiple side branch portals 110 to be implemented (e.g., each side branch portal 110 has the same diameter), with the lower end of each side branch portal 110 aligned with the inlet portion 160 of the portal access mechanism 150 and the upper end aligned with the outer profile of the main body 100 (not shown). The portal access mechanism 150 can also include a transition portion 162. The transition portion 162 includes a portion of the wall 104 that transitions to the inlet portion 160. The transition portion 162 can also be operable to accommodate the branch member 200 as it exits the side branch portal 110. In some embodiments, the transition portion 162 extends directly from the second opening 121 of the side branch portal 110 (not shown). In yet a further embodiment, the portal access mechanism 150 is a constriction (not shown) of the main body 100 proximate to the second opening 121 of the side branch portal 110.

[0072] It is understood that the portal access mechanism 150 need not begin at the second opening 121 of the side branch portal 110. For example, in some embodiments, the portal access mechanism 150 extends below the side branch portal 110. The side branch portal may be disposed between the portal access mechanism 150 and the outer layer of the graft member 130. In these embodiments, the portal access mechanism 150 extends from the side branch portal 110 toward the first end 106 of the main body 100.

[0073] 4, the portal access mechanism 150, in some embodiments, is unstented. In some embodiments, the stent structure 120 used to support the graft member 130 does not extend over the portal access mechanism 150. For example, in embodiments in which the stent structure 120 is helically wound, the stent structure 120 does not extend across the portal access mechanism 150, but instead has a longitudinal portion 170 that extends along the length of the main body 100 near the portal access mechanism 150 and extends away from the portal access mechanism 150 at each end of the longitudinal portion 170. It is understood that the stent structure 120, while generally helically wound, can include various features such as apexes 172, sinusoidal shapes, etc. In other embodiments, the stent structure 120 can include multiple independent rings spaced longitudinally along the length of the main body 100. The rings of the stent structure 120 disposed along the longitudinal length of the main body 100 shared with the portal access mechanism 150 may terminate near the portal access mechanism 150 rather than extending entirely around the main body 100, or may include longitudinal portions connecting the rings as described with respect to the spiral winding.

[0074] In other embodiments, the stent structure 120 can extend across the portal access feature 150. For example, FIG. 10 illustrates an embodiment in which the stent structure 120 extends across the portal access feature 150, where the stent structure is shaped and / or shaped to accommodate and / or shape the profile of the portal access feature 150. The portion of the stent structure 120 defined over the portal access feature 150 may be continuous with the remainder of the stent structure 120. For example, in a main body 100 implementing a stent structure 120 that is helically disposed or wrapped around the main body 100, the stent structure 120 may continue its helical path substantially in the portal access feature 150. In some embodiments, the apexes 170a of the stent structure 120 at the portal access feature 150 may be shorter than the apexes 170b around the remainder of the main body 100 (see FIG. 11). Additionally, the frequency can be reduced so that more apexes are incorporated into the circumference of the main body 100 at the portal access feature 150. In other embodiments, the stent structure 120 disposed in the portal access feature 150 is shaped to contour or otherwise match the peripheral profile of the portal access feature 150. In these embodiments, the stent structure 120 of the portal access feature 150 extends from or is coupled to the stent structure 120 of the remainder of the main body 100, but has a shape that is independent of or does not match the pattern of the stent structure 120 of the remainder of the main body 100.

[0075] In some embodiments, the portal access mechanism 150 may include a portal access stent 151 (FIG. 15) that is separate from the stent structure 120, as previously described. The separate stent member may be coupled to the graft member 130 at the portal access mechanism 150. The separate stent member may incorporate any number of configurations, including patterns operable to match the peripheral profile of the portal access mechanism 150.

[0076] The portal access mechanism 150 may further include a reinforcement material. The reinforcement material is operable to increase the strength of the portal access mechanism 150. The reinforcement material may withstand tears, punctures, and other damage that may be caused by the portal access mechanism 150 as the device 10 is deployed. For example, cannulation and / or delivery and deployment of the branch member 200 may result in contact with the portal access mechanism, and the reinforcement material is robust enough to withstand tears or abrasions that may cause damage to the device 10. In some embodiments, the reinforcement material is applied to the portal access mechanism, incorporated into the graft member 130 at the portal access mechanism, or a combination thereof. A variety of materials may be implemented in the reinforcement material, including, but not limited to, a dense ePTFE layer or multiple layers.

[0077] 1 and 2, a branch member 200 may be deployed through the side branch portal 110. The branch member 200 may include a stent, a stent graft, a graft, or the like. The stents and stent grafts may be, for example, self-expanding or balloon-expandable. In one example, the device 10 may be deployed within the aortic arch. As shown, the device 10 includes a main body 100 with three side branch portals 110, although various numbers of side branch portals 110 are contemplated. In various embodiments, the first side branch portal 110a is operable to be cannulated to deploy a first branch body 200a of the brachiocephalic artery, the second side branch portal 110b is operable to be cannulated to deploy a second branch body 200b for the left common carotid artery, and the third side branch portal 110b is operable to be cannulated to deploy a third branch body 200c for the left subclavian artery.

[0078] The device 10, including the main body 100 and branch members 200 described above, can be constructed from any material suitable for use as a graft or stent-graft in a selected body lumen. The grafts can be constructed from the same or different materials. Additionally, the grafts can include multiple layers of material, which can be the same or different materials. In some instances, the grafts can have several layers of material, including a layer formed into a tube (the innermost tube) and an outermost layer formed into a tube (the outermost tube).

[0079] A variety of material sets may be implemented for the graft members, including known vascular graft and stent graft materials. Polymeric, biodegradable and natural materials may be used for specific applications. Additionally, a variety of manufacturing techniques may be implemented to form the graft members, including extrusion, coating, wrapping, combinations thereof, and the like.

[0080] Biocompatible materials for the graft components discussed herein can be used. In certain examples, the graft can include a fluoropolymer, such as polytetrafluoroethylene (PTFE) polymer or expanded polytetrafluoroethylene (ePTFE) polymer. In certain examples, the graft can be formed from, but is not limited to, polyester, silicone, urethane, polyethylene terephthalate, or another biocompatible polymer, 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.

[0081] Examples of suitable synthetic polymers include, but are not limited to, nylon, polyacrylamide, polycarbonate, polyformaldehyde, polymethylmethacrylate, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, polyethylene, polypropylene, polyurethane, polyglycolic acid, polyester, polyamide, mixtures, blends and copolymers thereof, which are suitable as graft materials. In one embodiment, the graft is made from a class of polyesters such as polyethylene terephthalates, including DACRON® and MYLAR®, and polyaramids such as KEVLAR®, polyfluorocarbons such as polytetrafluoroethylene (PTFE) with or without copolymerized hexafluoropropylene (TEFLON® or GORE-TEX®), and porous or non-porous polyurethanes. In another embodiment, the graft comprises an expanded fluorocarbon polymer (particularly PTFE) material. Preferred types of fluoropolymers include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), copolymers of tetrafluoroethylene (TFE) and perfluoro(propyl vinyl ether) (PFA), homopolymers of polychlorotrifluoroethylene (PCTFE) and its copolymers with TFE, ethylene chlorotrifluoroethylene (ECTFE), copolymers of ethylene-tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF) and polyvinyl fluoride (PVF). ePTFE is particularly preferred because it is widely used in artificial blood vessels. In another embodiment, the graft comprises a combination of the materials listed above. In another embodiment, the graft is substantially impermeable to body fluids. A substantially impermeable graft can be made from a material that is substantially impermeable to body fluids, or can be constructed from a permeable material that has been treated or manufactured to be substantially impermeable to body fluids (e.g., by layering different types of materials as described above or known in the art).In one embodiment, the main body and branch members are made from any combination of the above materials, as described above, hi another embodiment, the main body and branch members comprise ePTFE, as described above.

[0082] The stent, as described above, is generally cylindrical when constrained and / or unconstrained and may include helically arranged corrugations having a plurality of helical turns. The corrugations are preferably aligned to be "in phase" with one another. More specifically, the corrugations include apices in opposing first and second directions. When the corrugations are in phase, the apices of adjacent helical turns are aligned such that they can be displaced into the respective apices of corresponding corrugations of adjacent helical turns. In one embodiment, the corrugations have a sinusoidal shape. In another embodiment, the corrugations are U-shaped. In another embodiment, the corrugations are V-shaped. In another embodiment, the corrugations are ovoid.

[0083] In another embodiment, the stent may be provided in the form of a series of rings arranged generally coaxially along the graft body, as described above.

[0084] In various embodiments, the stent can be manufactured from a variety of biocompatible materials, including commonly known materials (or combinations of materials) used in the manufacture of implantable medical devices. Exemplary materials include 316L stainless steel, cobalt-chromium-nickel-molybdenum aluminum alloy ("cobalt-chromium"), other cobalt alloys such as L605, tantalum, nitinol, or other biocompatible metals. In one embodiment, any of the stent grafts described herein are balloon expandable stent grafts. In another embodiment, any of the stent grafts described herein are self-expanding stent grafts. In another embodiment, the stent is a wound stent. In another embodiment, the wound stent includes a wavy or repeating wavy pattern of apices.

[0085] A wound stent can be constructed from a reasonably high strength material, e.g., a material that resists plastic deformation when stressed. In one embodiment, the stent member comprises a wire that is spirally wound around a mandrel on which pins are placed so that the wire can be simultaneously spirally wound and corrugated, as described below. Other constructions can also be used. For example, the appropriate shape can be formed from a flat stock material and rolled into a cylinder, or formed into the appropriate shape or formed from a length of tubing that is laser cut from a sheet of material. In another embodiment, the stent is made from a superelastic alloy. There are various disclosures of the use of superelastic alloys, such as Nitinol, in stents.

[0086] A variety of materials, including various metals such as Nitinol, superelastic alloys, are suitable for use in these stents. The primary requirement of the material is that it be adequately elastic, even when formed into very thin sheets or small diameter wires. Various stainless steels that have been treated physically, chemically, or otherwise to produce high springiness are suitable, as are other metal alloys such as cobalt chromium alloys (e.g., ELGILOY®), platinum / tungsten alloys, and especially the nickel titanium alloy commonly known as "Nitinol."

[0087] Nitinol is particularly preferred due to its "superelastic" or "pseudoelastic" shape recovery properties, i.e., the ability to withstand significant amounts of bending and flexing and yet return to its original shape without permanent deformation. These metals are characterized by their ability to transform from an austenitic crystal structure to a stress-induced martensitic structure at certain temperatures and then elastically return to the austenitic shape when the stress is released. These alternating crystal structures give the alloy its superelastic properties.

[0088] Other suitable stent materials include certain polymeric materials, especially engineering plastics such as thermotropic liquid crystal polymers ("LCPs"). These polymers are high molecular weight materials that can exist in a so-called "liquid crystal state", where the material has some liquid properties (in that it can flow) while retaining the long-range molecular order of a crystal. The term "thermotropic" refers to a class of LCPs that are formed by temperature tuning. LCPs can be prepared from monomers such as p,p'-dihydroxy-polynuclear aromatics or dicarboxy-polynuclear aromatics. LCPs are easily formed and retain the necessary interpolymeric attractions at room temperature to function as the high strength plastic fabrication required for a collapsible stent. They are particularly suitable when augmented or filled with fibers, such as metal or alloy fibers described below. It should be noted that the fibers need not be straight, but may have some preformed properties such as corrugation that enhance the physical torsional reinforcement capabilities of the composite.

[0089] Any of a variety of bioactive agents may be implemented with any of the above. For example, any one or more of the devices 10 (including portions thereof) may include a bioactive agent. A bioactive agent may be coated onto one or more of the above-mentioned features to provide a controlled release of the bioactive agent when the device 10 is implanted. Such bioactive agents may include, but are not limited to, thrombogenic agents such as heparin. Bioactive agents include, but are not limited to, natural products such as vinca alkaloids (e.g., vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (e.g., etoposide and teniposide), antibiotics (e.g., dactinomycin (actinomycin D), daunorubicin, doxorubicin, idarubicin), anthracyclines, mitoxantrone, bleomycin, plicamycin (mithramycin), and mitomycin, enzymes (e.g., L-asparaginase, which metabolizes L-asparagine systemically, depriving cells that are unable to synthesize their own asparagine), G(GP) Antiplatelet agents such as IIb / IIIa inhibitors and vitronectin receptor antagonists, antiproliferative / antimitotic alkylating agents such as nitrogen mustards (e.g., mechlorethamine, cyclophosphamide and its analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (e.g., hexamethylmelamine and thiotepa), alkylsulfonates busulfan, nitrosoureas (e.g., carmustine (BCNU) and analogs, streptozocin), trazendacarbazine (DTIC), antiproliferative / antimitotic antimetabolites, such as folic acid analogs (e.g., methotrexate), pyrimidine analogs (e.g., fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (e.g., mercaptopurine, thioguanine, pentostatin, and 2-chlorodeoxyadenosine {cladribine}, etc.), platinum coordination complexes (e.g., cisplatin and carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide, hormones (e.g., estrogens), anticoagulants (e.g., heparin, synthetic heparin salts, and other thrombin inhibitors), antiplatelet agents (e.g., aspirin,clopidogrel, prasugrel and ticagrelor), vasodilators (e.g., heparin, aspirin), fibrinolytics (e.g., plasminogen activators, streptokinase and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab, anti-transitional agents, antisecretory agents (e.g., bleberdin), anti-inflammatory agents, for example, corticosteroids (e.g., cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone, triamcinolone, betamethasone and dexamethasone), non-steroidal agents (e.g., salicylic acid derivatives such as aspirin), para-aminophenol derivatives (e.g., acetaminophen), indole and indene acetic acids (e.g., indomethacin, sulindac and etodalac), heteroaryl acetic acids (e.g., tolmetin, diclofenac and ketorolac), arylpropionic acids (e.g., ibuprofen and derivatives), anthranilic acids (e.g., mefenamic acid and meclofenamic acid), enolic acids (e.g., piroxicam, tenoxicam, phenylbutazone and oxyfentatrazone), nabumetone, gold compounds (e.g., auranofin, aurothioglucose and sodium gold thiomalate), immunosuppressants (e.g., cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine and mycophenolate mofetil), angiogenic agents (e.g., vascular endothelial growth factor (VEGF)), fibroblast growth factor (FGF), angiotensin receptor blockers, nitric oxide donors, antisense oligonucleotides and combinations thereof, cell cycle inhibitors, mTOR inhibitors, growth factor receptor signaling kinase inhibitors, retinoids, cyclin / CDK inhibitors, HMG coenzyme reductase inhibitors (statins) and protease inhibitors.

[0090] Various methods of deploying device 10 may be performed. For example, a method of deploying an endoprosthesis at a target site having a main lumen and a first branch lumen (e.g., the aortic arch with the brachiocephalic trunk, left common carotid artery, and left subclavian artery) may include: (1) advancing a main body of a multi-branch stent graft toward a main lumen of a target site, where the main body has a first portion and a second portion, the main body defining a first portal operable to provide fluid access from the main body to a first side branch extending from the target site when the main body is deployed at the target site; (2) advancing the first portal of the main body toward a main lumen of the target site; (3) advancing a first articulatable wire through the first portal and into the first branch lumen; (4) partially deploying the second portion of the main body within the main lumen of the target site; (5) fully deploying the first and second portions of the main body; (6) advancing a first side branch body along the first articulatable wire into the first branch lumen of the target site; and (7) deploying the first side branch body within the first side branch lumen of the target site.

[0091] In some embodiments, the first portal has a first end and a second end, the second end being substantially continuous with the exterior surface of the main body, thereby maintaining the exterior profile of the device to conform to the surrounding anatomy. The main body defines a main body longitudinal axis, and the first portal defines a first portal longitudinal axis, the main body longitudinal axis and the first portal longitudinal axis being substantially parallel. In some embodiments, the first portal is positioned such that the first portal from the first end to the second end is counter-rotating with respect to fluid flow through the main body. The wall of the main body can define a recess adjacent the first portal such that when the first articulatable wire and the first side branch body are advanced, the recess provides clearance for the first articulatable wire and the first side branch body to exit the portal without kinking. In some embodiments, the main body includes a stent coupled to the wall, and the portion of the wall defining the recess does not include a stent.

[0092] In embodiments in which the main body includes the second and third portals of claim 10, the method may further include (1) advancing a second articulatable wire through the second portal into the second branch lumen at the target site, (2) advancing a third articulatable wire through the third portal into the third branch lumen at the target site, (3) advancing a second side branch body along the second articulatable wire into the second branch lumen at the target site, and (4) advancing a third side branch body along the third articulatable wire into the third branch lumen at the target site. In these embodiments, the first side branch body may be deployed prior to deploying the second and third side branch bodies. Various configurations of the portals may be implemented, including where the outer openings of the first, second and third portals are each located at a first longitudinal position along the main body, or where the outer openings of the first, second and third portals are each located at different longitudinal positions along the main body. In some embodiments, the method further includes adjusting an internal curvature of the main body prior to fully deploying the first and second portions of the main body.

[0093] Numerous features and advantages of the present invention have been set forth in the preceding description, including preferred and alternative embodiments, along with details of the structure and function of the present invention. This disclosure is for illustrative purposes only, and is therefore not intended to be exhaustive. It will be apparent to those skilled in the art that various changes may be made, particularly with respect to the structure, materials, elements, components, shapes, sizes and arrangements of parts, within the scope of the principles of the present invention, to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed. These various changes are intended to be encompassed within the scope of the appended claims, unless they depart from the spirit and scope of the appended claims. In addition to the embodiments described above and claimed below, the present invention is further directed to embodiments having different combinations of the features described above and claimed below.

[0094] 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 main body including a tubular element having a wall defining a main lumen, the tubular element having a first end defining a first opening into the main lumen and a second end defining a second opening into the main lumen, the tubular element including at least one side branch portal defining an aperture through a wall between the first and second longitudinal ends of the tubular element; at least one secondary body defining a secondary lumen, wherein the at least one secondary body is operable to be deployed with a portion of the secondary body disposed within the at least one side branch portal of the main body; Multi-branched implantable devices, including:

2. 10. The multi-branch device of claim 1, wherein the at least one side branch portal has a first end and a second end, and the secondary body is operable to be deployed such that the second end of the side branch portal is substantially continuous with an outer surface of the main body.

3. 10. The multi-branch device of any one of the preceding claims, wherein when the main body is in a neutral, unbent configuration, a first opening at a first longitudinal end of the tubular element faces in a first direction and a second end of the at least one side branch portal faces substantially in the first direction.

4. 3. The multi-branch device of claim 1 or claim 2, wherein when the main body is in a neutral, unbent configuration, a second opening at a second longitudinal end of the tubular element faces in a second direction and a second end of the at least one side branch portal faces substantially in the second direction.

5. 2. The multi-branch device of any one of the preceding claims, wherein the wall of the main body defines a recess adjacent at least one side branch portal.

6. 2. The multi-branch device of any one of the preceding claims, wherein the main body further comprises a stent coupled to the wall.

7. 2. A multi-branched device according to any one of the preceding claims, wherein the portion of the wall defining the recess is unsupported.

8. 10. The multi-branch device of any one of the preceding claims, wherein the at least one side branch portal includes a first portal, a second portal and a third portal, each having an external opening disposed at a first longitudinal position along the main body.

9. The multi-branch device of any one of claims 1 to 7, wherein the at least one side branch portal includes a first portal, a second portal, and a third portal, each having an external opening disposed at one of at least two longitudinal positions along the main body.

10. 1. A method for deploying an endoprosthesis at a target site having a main lumen and a first branch lumen, comprising: The method comprises: advancing a main body of a multi-branch stent graft toward a main lumen of a target site, said main body having a first portion and a second portion, said main body defining a first portal operable to provide fluid access from said main body to a first side branch extending from said target site when said main body is deployed at said target site; partially deploying the first portion of the main body within the main lumen of the target site; advancing a first articulatable wire through the first portal and into the first branch lumen; partially deploying the second portion of the main body within the main lumen of the target site; fully deploying the first and second portions of the main body; advancing a first side branch body along the first articulatable wire into the first branch lumen of the target site; and deploying the first side branch body within the first branch lumen at the target site; A method comprising:

11. The method of claim 10 , wherein the first portal has a first end and a second end, the second end being substantially contiguous with an exterior surface of the main body.

12. 12. The method of claim 10 or 11, wherein the main body defines a main body longitudinal axis, the first portal defines a first portal longitudinal axis, and the main body longitudinal axis and the first portal longitudinal axis are substantially parallel.

13. 13. The method of any one of claims 10 to 12, wherein the first portal is positioned such that the first portal from the first end to the second end is counter-current to fluid flow through the main body.

14. 14. The method of any one of claims 10-13, wherein a wall of the main body defines a recess adjacent the first portal such that the recess provides clearance for the first articulatable wire and first side branch body to exit the first portal without kinking when the first articulatable wire and first side branch body are advanced.

15. The method of any one of claims 10 to 14, wherein the main body includes a stent coupled to the wall, and the portion of the wall defining the recess does not include a stent.

16. the main body includes a second portal and a third portal; The method comprises: advancing the second articulatable wire through the second portal and into a second branch lumen of the target site; advancing a third articulatable wire through the third portal and into a third branch lumen of the target site; advancing a second side branch body along the second articulatable wire into the second branch lumen at the target site; and advancing a third side branch body along the third articulatable wire into the third branch lumen at the target site; The method of claim 10, further comprising:

17. The method of claim 16 , wherein the first side branch body is deployed prior to deploying the second side branch body and the third side branch body.

18. 18. The method of claim 16 or 17, wherein the exterior openings of each of the first portal, the second portal and the third portal are each disposed at a first longitudinal position along the main body.

19. 18. The method of claim 16 or 17, wherein each external opening of the first portal, the second portal and the third portal has an external opening disposed at one of at least two longitudinal positions along the main body.

20. The method of any one of claims 10 to 19, further comprising adjusting an internal curvature of the main body prior to fully deploying the first and second portions of the main body.

21. The method of claim 16 , wherein each of the side branch bodies is deployed substantially simultaneously.

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