Multi-component delivery system and method

Abstract

To provide an excellent system or the like.SOLUTION: A method of deploying a multifurcated stent graft at a target site having a main lumen and a first branch lumen is provided. The method includes: Advancing a catheter comprising a main body having a first portion and a second portion, the main body defining a first portal pre-cannulated with a first guide member; Partially deploying the first portion of the main body; Advancing a first sheath along the first guide member through the first portal; Advancing a first articulatable wire through the first sheath; Positioning the first articulatable wire in a first branch lumen of the target site; Partially deploying the second portion of the main body; Fully deploying the first portion and the second portion of the main body; Advancing a first side branch body along the first articulatable wire into the first branch lumen; Deploying the first side branch body within the first branch lumen.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 63 / 152,144, filed February 22, 2021, which is incorporated herein by reference in its entirety for all purposes.

[0002] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to systems and methods for delivering multi-component devices, and more particularly to systems and methods for delivering intravascular devices including individual components to a target site. [Background technology]

[0003] background Various branched anatomical passageways can benefit from treatment in the form of implanted intraluminal devices. One such passageway is a vascular passageway, such as an aneurysmal artery. Aortic disease and trauma, such as aneurysms and dissections, pose significant risks to patients. The risks increase based on the patient's condition. Such conditions or factors may include the patient's age, pre-existing and / or associated conditions, such as cardiopulmonary bypass, cardiac arrest, or circulatory arrest. These and other factors may limit a patient's ability to tolerate and recover from surgery to repair aortic disease. This same problem exists for other diseased and injured tissues in a patient.

[0004] In the context of aneurysms, stent grafts can be percutaneously introduced into the vessel and deployed to span the aneurysmal sac to prevent aneurysm rupture. The stent graft comprises a graft fabric secured to a tubular scaffolding or framework of one or more stents. The stents not only provide the rigidity and structure to hold the graft open in its tubular configuration, but also provide the outward radial force necessary to form a seal between the graft and the healthy portion of the vessel wall and provide transition resistance. Blood flowing through the vessel flows through the luminal surface of the stent graft, reducing, if not eliminating, 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] 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 placement of a stent graft at the bifurcation. Therefore, a bifurcated stent graft is required in such cases. Modular stent grafts having separate main body and branch components are often preferred in these procedures due to ease and precision of deployment. See U.S. Patent Application Publication No. 2008 / 0114446 to Hartley et al. for an example of a modular stent graft having separate main body and branch stent components. In the Hartley et al. publication, the main body stent has fenestrations in its sidewall that are tailored to engage and secure a side branch stent. Summary of the Invention

[0006] Abstract The endoprosthesis includes a main body and includes 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. Methods for deploying an endoprosthesis are also provided.

[0007] According to one example ("Example 1"), a method of deployment includes providing a multi-branch stent graft at a target site having a main lumen and a first branch lumen, the method including: advancing a main guidewire to the target site; advancing a catheter including a main body of the multi-branch stent graft along the main guidewire toward the main lumen of the target site, the main body having 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, the first portal being pre-cannulated with a first secondary guidewire prior to advancing the main body along the main guidewire; The method includes partially deploying the first portion of the body within the main lumen of the target site, advancing a first sheath along a first guide member through the first portal, advancing a first articulatable wire or guide catheter through the first sheath, positioning the first articulatable wire or guide catheter within a first branch lumen of the target site, 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 or guide catheter 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.

[0008] According to another example ("Example 2"), further to Example 1, the method includes deploying an embolic filter within a first branch lumen of the target site.

[0009] According to another example ("Example 3"), in addition to Example 2, the method includes aspirating a filter sheath of the embolic filter.

[0010] According to another example ("Example 4"), in addition to Example 3, the method includes removing the embolic filter after the first side branch body is deployed.

[0011] According to another example ("Example 5"), in addition to any of the examples above, the first guide member includes a first end that is looped around a cap of the catheter.

[0012] According to another example ("Example 6"), in addition to any of the examples above, the main body further defines second and third portals operable to provide fluid access from the main body to second and third side branches extending from the target site when the main body is deployed at the target site, and the second portal is pre-cannulated with a second guide member and the third portal is pre-cannulated with a third guide member prior to advancing the main body along the main guidewire.

[0013] According to another example ("Example 7"), in addition to Example 6, further includes advancing a second sheath through the second portal along the second guide member, advancing a second articulatable wire or guide catheter through the second sheath, and disposing the second articulatable wire or guide catheter within a second branch lumen at the target site, advancing a third sheath through the third portal along the third guide member, advancing a third articulatable wire or guide catheter through the third sheath, and disposing the third articulatable wire or guide catheter within a third branch lumen at the target site.

[0014] According to another example ("Example 8"), further to Example 7, the method includes advancing a second side branch body along the second articulatable wire or guide catheter into a second branch lumen at the target site; deploying the second side branch body within the second branch lumen at the target site; advancing a third side branch body along the third articulatable wire or guide catheter into a third branch lumen at the target site; and deploying the third side branch body within the third branch lumen at the target site.

[0015] According to another example ("Example 9"), in addition to Example 8, the method further includes removing the main guidewire, the first guide member, the second guide member, and the third guide member, and the first sheath, the second sheath, and the third sheath.

[0016] According to another example ("Example 10"), in addition to Example 9, the catheter is removed before advancing the first sheath, the second sheath, and the third sheath.

[0017] According to another example ("Example 11"), an endoprosthesis delivery system includes an endoprosthesis including an elongate member having a first end and a second end, an end cap coupled to the first end of the elongate member, a main body defining a main lumen and at least one side branch portal, and at least one second body defining a secondary lumen, and at least one guide member extending through the at least one side branch portal and coupled to the end cap.

[0018] According to another example ("Example 12"), in addition to example 11, the endoprosthesis delivery system further includes a restraining member that restrains the endoprosthesis main body to the elongate member.

[0019] According to another example ("Example 13"), further to Example 12, in the endoprosthesis delivery system, the restraining member is operable to restrain the main body in a restrained configuration and a partially deployed configuration, and the main body has a first diameter in the restrained configuration, a second diameter greater than the first diameter in the partially deployed configuration, and a third diameter greater than the first diameter and the second diameter in the deployed configuration.

[0020] According to another example ("Example 14"), further to Example 13, in the endoprosthesis delivery system, the restraining member includes a first portion and a second portion, the first portion and the second portion independently operable to restrain corresponding first and second portions of the main body in a restrained configuration and a partially deployed configuration.

[0021] According to another example ("Example 15"), in addition to any of Examples 11-14, the endoprosthesis delivery system further includes a sheath operable to be advanced along the at least one guide member.

[0022] According to another example ("Example 16"), in addition to example 15, the endoprosthesis delivery system further includes an articulatable wire or guide catheter operable to be advanced through the sheath.

[0023] According to another example ("Example 17"), in addition to Example 16, the endoprosthesis delivery system further includes at least one secondary branch operable to advance along the articulatable wire or guide catheter and be deployed at least partially within the at least one side branch portal.

[0024] According to another example ("Example 18"), in addition to example 17, the endoprosthesis delivery system further includes a removable filter operable to be deployed downstream from the target site of the endoprosthesis.

[0025] According to another example ("Example 19"), in addition to example 18, in the endoprosthesis delivery system, the removable filter includes a central lumen operable for the articulatable or guide catheter wire to extend therethrough.

[0026] According to another example ("Example 20"), further to any one of Examples 11-19, in the endoprosthesis delivery system, the end caps are curved.

[0027] According to another example ("Example 21"), in addition to the endoprosthesis delivery system of any one of Examples 11-20, the endoprosthesis delivery system curves from the end cap through the main body.

[0028] According to another example ("Example 22"), an endoprosthesis delivery system includes an elongate member having a first end and a second end, an endoprosthesis longitudinally disposed between the first end and the second end of the elongate member, wherein the endoprosthesis includes a main body defining a main lumen and a side branch portal, a guide member extending through the side branch portal, and a guide member holder removably coupled to the elongate member at a coupling position, wherein the guide member is coupled to the guide member holder at a position between the side branch portal and the coupling position of the guide member holder.

[0029] According to another example ("Example 23"), the endoprosthesis delivery system of Example 22 further includes the main body defining a plurality of side branch portals.

[0030] According to another example ("Example 24"), the endoprosthesis delivery system of either Example 22 or Example 23 further includes a plurality of guide members.

[0031] According to another example ("Example 25"), in addition to the endoprosthesis delivery system of any one of Examples 22 to 24, the guide member retainer extends through loops formed at each end of the guide member.

[0032] According to another example ("Example 26"), the endoprosthesis delivery system of any one of Examples 22-25 further includes the guide member retainer being operable to be selectively decoupled from the first coupled position.

[0033] According to another example ("Example 27"), in addition to the endoprosthesis delivery system of any one of Examples 22-26, the elongate member includes a lockwire retainer disposed at a first end of the elongate member.

[0034] According to another example ("Example 28"), in addition to the endoprosthesis delivery system of Example 27, the guide member retainer is releasably coupled to the lockwire retainer.

[0035] According to another example ("Example 29"), in addition to the endoprosthesis delivery system of any one of Examples 22 to 28, the system further includes side branch bodies, each guide member including a first end, each of the first ends of the guide members being held by the guide member holder between the attachment location and the side branch portal when the side branch body is advanced along the guide members.

[0036] According to another example ("Example 30"), in addition to the endoprosthesis delivery system of any one of Examples 22 to 29, each guide member is operable to be removed from the corresponding side branch portal when the guide member holder is released.

[0037] According to another example ("Example 31"), in addition to the endoprosthesis delivery system of any one of Examples 22 to 30, the system further includes a plurality of guide member holders, each guide member holder being coupled to a corresponding guide member.

[0038] According to another example ("Example 32"), in addition to the endoprosthesis delivery system of Example 29, each guide member holder is operable to be individually and selectively released from engagement at the first docking position such that each guide member is operable to be individually removed from the corresponding side branch portal.

[0039] According to another example ("Example 33"), in addition to the endoprosthesis delivery system of Example 22, the elongate member includes a cap disposed on a first end of the elongate member, and the guide member retainer is coupled to the cap at a coupling position.

[0040] According to another example ("Example 34"), in addition to the endoprosthesis delivery system of any one of Examples 22-33, the guide member holder is coupled to the elongate member at a first end of the elongate member.

[0041] The foregoing examples are merely illustrative and should not be construed to limit or narrow 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 are to be regarded as illustrative in nature and not as restrictive. [Brief explanation of the drawings]

[0042] 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.

[0043] [Figure 1] FIG. 1 is a diagram of a delivery system according to one embodiment.

[0044] [Figure 2] FIG. 2 is a front view of an implantable device with a main body and a side branch deployed within the aorta and adjacent side branch, according to one embodiment.

[0045] [Figure 3] FIG. 3 is a top view of the main body of an implantable device, according to one embodiment, which includes a side branch portal through which a side branch body can be delivered and deployed.

[0046] [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 body delivered and deployed through the side branch portal.

[0047] [Figure 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.

[0048] [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.

[0049] [Figure 7] FIG. 7 is a perspective view of a main body including side branch portals staggered along the longitudinal length of the main body, according to one embodiment.

[0050] [Figure 8] FIG. 8 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.

[0051] [Figure 9] FIG. 9 is a cross-sectional view of a patient's aorta according to one embodiment.

[0052] [Figure 10] FIG. 10 is a diagram of a filtration system deployed within a patient's vasculature, according to one embodiment.

[0053] [Figure 11A] FIG. 11A shows the main body of an implantable device being delivered to a target site, according to one embodiment, the main body including a pre-cannulated side branch portal.

[0054] [Figure 11B] FIG. 11B is an illustration of a delivery system with a guide member holder that holds a guide member via a lock wire holder, according to one embodiment.

[0055] [Figure 11C] FIG. 11C is a diagram of a delivery system with a lock wire, where the delivery system is steerable, according to one embodiment.

[0056] [Figure 12] FIG. 12 is a diagram of a main body including a first region and a second region, with the second region partially deployed, according to one embodiment.

[0057] [Figure 13A] FIG. 13A is an illustration of a sheath being advanced along a guide member cannulating a side branch portal in a main body, according to one embodiment. [Figure 13B] FIG. 13B is an illustration of a sheath being advanced along a guide member cannulating a side branch portal in the main body, according to one embodiment. [Figure 13C] FIG. 13C is an illustration of a sheath being advanced along a guide member cannulating a side branch portal in the main body, according to one embodiment.

[0058] [Figure 14] FIG. 14 is a diagram of an articulatable guide catheter and / or wire advanced through a sheath and positioned in a side branch of a target lumen, according to one embodiment.

[0059] [Figure 15] FIG. 15 is a diagram of an articulatable wire advancing within a filtration system for a through-and-through configuration between access sites, according to one embodiment.

[0060] [Figure 16] FIG. 16 is an illustration of an articulatable wire positioned in each of the side branches of a target site, according to one embodiment.

[0061] [Figure 17]FIG. 17 is a diagram of the main body partially deployed along its entire longitudinal length to precisely position the main body within the target lumen, according to one embodiment.

[0062] [Figure 18] FIG. 18 is a diagram of the main body fully deployed within the target lumen, according to one embodiment.

[0063] [Figure 19] FIG. 19 is a diagram of a side branch body being delivered to a corresponding branch at a target site, according to one embodiment.

[0064] [Figure 20] FIG. 20 is an illustration of a side branch body being deployed with a corresponding branch at a target site, according to one embodiment.

[0065] [Figure 21] FIG. 21 is a diagram of a side branch body delivery system being removed from a target site, according to one embodiment.

[0066] [Figure 22] 22 is a diagram of the filtration system being aspirated prior to removal of the delivery system and used to deploy an implantable device at a bifurcation target site, according to one embodiment; and

[0067] [Figure 23] FIG. 23 is a diagram of an implantable device implanted as a bifurcation target site prior to removal of multiple guidewires used to cannulate portions of the bifurcation target site, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0068] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a restrictive manner, for example, the terms used in this application should be read broadly in the context of the meanings ascribed to such terms by experts in the field.

[0069] Those skilled in the art will readily appreciate that 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 regard, the drawings should not be construed as limiting.

[0070] 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," etc., are used in a relative sense (e.g., how 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.

[0071] 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 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 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 the object by a person or machine, etc.

[0072] As used herein, "couple" means to join, connect, attach, adhere, affix or bond, whether directly or indirectly and permanently or temporarily.

[0073] 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 then rapidly retract to nearly its original length upon release. The term "elastomeric material" refers to a polymer or mixture of polymers that exhibits stretch and recovery properties similar to those of 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 dissimilar to either elastomers or elastomeric materials, i.e., are not considered to be elastomers or elastomeric materials as commonly known.

[0074] The term "film," as used herein, refers collectively to one or more of a membrane, a composite, or a laminate.

[0075] 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.

[0076] For reference, the terms "perimeter" 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 outer surface or dimension, or the dimension between opposing surfaces of an outer surface.

[0077] Although embodiments herein may be described in conjunction with various principles and beliefs, the described embodiments should not be bound by theory. For example, embodiments are described herein in conjunction with vascular stent grafts, and more specifically, branched stent grafts. However, embodiments within the scope of this disclosure may be applied to any endoprosthesis of similar structure and / or function. Furthermore, embodiments within the scope of this disclosure may be applied to non-vascular applications.

[0078] 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 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.

[0079] Disclosed herein are devices, systems, and methods for endoluminal delivery of bifurcated, expandable implants according to various embodiments for treating diseases of the human vasculature. While the following description and figures are illustrated in the context of treating the aorta 20, including the ascending aorta 21, the aortic arch 22, and the descending aorta 23, and branches therefrom, including the brachiocephalic trunk 24, the left common carotid artery 25, and the left subclavian artery 26, it should be understood that the present disclosure is applicable to treating other portions of the vasculature, including, for example, larger blood vessels and any disease in which one or more branch vessels are treated.

[0080] Branchable expandable implant 2, implantable device 10 can be delivered and deployed within aorta 20, where implantable device 10 includes main body 100 and branch body 200. Main body 100 can be deployed within aortic arch 22, and branch body 200 can be deployed within branch arteries (e.g., first branch body 200a of brachiocephalic artery 24, second branch body 200b of left common carotid artery 25, and third branch body 200c of left subclavian artery 26).

[0081] While various configurations of implantable device 10 are contemplated for the delivery systems and methods described herein, several specific examples of implantable device 10 are provided in detail to provide a reference for the various components and steps of the delivery systems and delivery and deployment methods. For example, FIG. 3 is an exemplary embodiment of implantable device 10. Main body 100 includes a wall 104 that defines a main lumen 102. Main body 100 has a first end 106 and a second end 108. At first end 106, main body 100 includes a first opening 107, and at second end 108, main body 100 includes a second opening 109. Each of openings 107, 109 provides access to main lumen 102 at the corresponding end 106, 108. Fluid is operable to flow through the main lumen 102 by entering the main lumen 102 through a first opening 107 and exiting through a second opening 109, defining a main body fluid flow direction. Alternatively, 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.

[0082] 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 (e.g., the aorta 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 flexibility (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.

[0083] 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 a branch vessel. The side branch portal 110 forms or is disposed in an opening 112 through the wall 104 along the outer profile of the main body 100. In certain instances, 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 the main body 100 including 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.

[0084] 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 130 and thus represents a portion of the main body stent structure 130 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 130. Similarly, the side branch graft member 116 can 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 still 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 is within the scope of the present disclosure.

[0085] 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 (e.g., flush with) the wall 104 of the main body 100 and 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.

[0086] 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 can be 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. Side branch portal 110 can have varying longitudinal lengths. Furthermore, when multiple side branch portals 110 are implemented, each side branch portal 110 can have varying lengths or a uniform length. In embodiments implementing multiple side branch portals 110, it is understood that each side branch portal 110 can have an independent diameter or geometric orifice area.

[0087] 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 180-degree difference, but generally includes a change in fluid flow direction of more than 90 degrees. It is also understood that when the main body 100 is adapted to curved anatomy, the fluid flow direction is relative to a particular location along the longitudinal length of the main body 100. For example, embodiments in which the side branch fluid flow direction is opposite to 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 congested 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.

[0088] In other embodiments, the side branch portal 110 is oriented such that the side branch fluid flow direction is generally aligned 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 than the second opening 121 of the side branch portal 110. An antegrade orientation can be advantageous in some embodiments to maintain a more traditional fluid flow, particularly 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 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.

[0089] The second opening 121 of the side branch portal 110 can be positioned 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 positioned approximately at the midpoint between 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 positioned 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 longitudinally aligned along the length of the main body 100 (see FIG. 3), offset along the length of the main body 100 (see FIG. 7), or a combination thereof (see FIG. 8).

[0090] 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. Note that in embodiments where multiple side branch portals 110 are implemented, if one or more side branch portals are not required for a particular application, a plug (not shown) can be inserted into any one or more of the side branch portals 110. For example, the device 10 may include three side branch portals 110, but only two are needed in 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., with a plug).

[0091] In some embodiments, stent structure 120 extends around the circumference of side branch portal 110. In embodiments implementing side branch stent structure 114, which may be implemented with a less obtrusive material or may be implemented with a material that provides less retention or expansion force than main body stent structure 120, stent structure 120 may extend around side branch portal 110 to limit collapse of side branch portal 110 (and, when included, side branch stent structure 114) during delivery, deployment, and use of device 10. However, in some embodiments, stent structure 120 does not extend around side branch portal 110.

[0092] 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 a branch body 200 at least partially disposed within and deployed 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, excluding the longitudinal length of the main body 100 that defines the portal access mechanism 150. FIG. 5 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.

[0093] Referring again to FIG. 4 , the portal access mechanism 150 is defined within 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 from the second opening 121 of the side branch portal 110 to the depth 158 to define an entry portion 160. The predetermined length of the entry portion 160 can provide sufficient space for the branch body 200 to exit the side branch portal 110 and rotate or bend toward the branch vessel, defining the entry portion 160 of the portal access mechanism 150. The entry portion 160 in some embodiments is substantially flat, as shown in FIG. 4 . However, in some embodiments, the entry portion 160 can incorporate a curvature. For example, in some embodiments, the entry portion 160 includes an arcuate profile. The arcuate profile allows for the implementation of multiple side branch portals 110 (e.g., each side branch portal 110 has the same diameter), with each side branch portal 110 having its lower end aligned with the inlet portion 160 of the portal access mechanism 150 and its 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 into the inlet portion 160. The transition portion 162 can also be operable to accommodate the branch body 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 narrowing (not shown) of the main body 100 proximate the second opening 121 of the side branch portal 110.

[0094] 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.

[0095] 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 spirally wound, the stent structure 120 does not extend across the portal access mechanism 150, but instead extends along the length of the main body 100 near the portal access mechanism 150, with a longitudinal portion extending away from the portal access mechanism 150 at each end of the longitudinal portion. While the stent structure 120 is generally spirally wound, it will be understood that it can include various features, such as apexes 170, a sinusoidal shape, etc. In other embodiments, the stent structure 120 can include multiple individual 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.

[0096] In other embodiments, the stent structure 120 can extend across the portal access mechanism 150. For example, in embodiments in which the stent structure 120 extends across the portal access mechanism 150, the stent structure can be shaped and / or shaped to accommodate and / or shape the profile of the portal access mechanism 150. The portion of the stent structure 120 defined over the portal access mechanism 150 can 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 can substantially continue its helical path in the portal access mechanism 150. In some embodiments, the apexes 170a of the stent structure 120 at the portal access mechanism 150 can be shorter than the apexes 170b around the remainder of the main body 100 (see FIG. 7 ). Additionally, the frequency can be reduced so that more vertices 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.

[0097] In some embodiments, the portal access mechanism 150 may include a portal access stent (not shown) that is separate from the stent structure 120, as previously described. The separate stent member may be coupled to the graft member 130 in 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.

[0098] The portal access mechanism 150 can further include a reinforcement material. The reinforcement material is operable to increase the strength of the portal access mechanism 150. The reinforcement material can withstand tears, punctures, and other damage that may be caused by the portal access mechanism 150 when the device 10 is deployed. For example, cannulation and / or delivery and deployment of the branch body 200 may result in contact with the portal access mechanism, and the reinforcement material is sturdy 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 can be implemented for the reinforcement material, including, but not limited to, a high-density ePTFE layer or multiple layers.

[0099] Delivery systems and methods of delivery and deployment Referring to FIG. 1 , a delivery system 1000 is shown (not necessarily to scale) that is operable to deliver a multi-component implantable device (e.g., implantable device 10) to a target site. The delivery system includes a handle 1100, an elongate member 1200 having a first end 1202 and a second end 1204 coupled to and / or extending from the handle 1100, a cap 1300 positioned proximate the second end 1204 of the elongate member 1200, and at least one guide member 1400 extending at least partially along the elongate member 1200 toward the cap 1300. The elongate member 1200 and the cap 1300 are operable to translate along a primary guidewire 1500 (see FIG. 10 ). The delivery system 1000 can further include at least one sheath 1600 (see FIGS. 13a-13c), operable for use with the guide member 1400 (when multiple guide members 1400a, 1400b, 1400c are present, each guide member 1400 has a corresponding sheath 1600). Each sheath 1600 can include an articulatable secondary guidewire 1700 (see FIG. 14). The delivery system 1000 can also include a restraining member 1800 (see FIG. 11) operable to restrain at least a portion of the multi-component implantable device. It will be understood that a separate restraining member 1800 can be implemented for each individual component of the multi-component implantable device. The delivery system 1000 can be used in combination with a filtration system 2000 (e.g., to reduce the risk of embolism, see FIG. 10). In some embodiments, the restraining member 1800 can include a window 1802 for the side branch portal 110, and the window 1802 of the restraining member 1800 is positioned to cover the side branch portal 110 so that the side branch portal 110 can be accessed when the restraining member 1800 is restraining the device 10 (see FIG. 24).

[0100] Referring to Figure 9, an exemplary target site for delivery and deployment of a multi-component implantable device is shown. In this example, the aorta 20 is shown. However, it is understood that the delivery system 1000 may be implemented in any portion of the vasculature, including branch lumens, as desired. In this example, the aorta 20 is shown, including the ascending aorta 21, aortic arch 22, and descending aorta 23, and branches therefrom, including the brachiocephalic trunk 24, left common carotid artery 25, and left subclavian artery 26.

[0101] FIG. 10 illustrates the implementation of a filtration system 2000 in conjunction with the delivery system 1000. The filtration system 2000 can include multiple deployable filters 2002 that can be deployed in discreet lumens, including side branch lumens, that are fluidly downstream from the target site where the multi-component implantable device is to be implanted. The filtration system 2000 can be flushed intermittently throughout the procedure. A primary guidewire 1500 is advanced to the target site (e.g., the aortic arch). While the primary guidewire 1500 is shown coming from the descending aorta 23 (e.g., from a femoral access site), the primary guidewire 1500 can be inserted from any suitable access site.

[0102] 11 , a multi-component implantable device is advanced to a target site over a guidewire 1500. For purposes of the examples provided herein, the multi-component implantable device includes the embodiments disclosed with respect to FIGS. 3-4. However, it is understood that the present method and delivery system 1000 is not limited to delivering only implantable devices 10 as described with reference to FIGS. 3 and 4. The implantable device (e.g., main body 100) is disposed on an elongate member 1200. For example, the implantable device 10 may be restrained in a compressed configuration about the elongate member 1200. The implantable device 10 may be restrained by a restraining member 1800. The implantable device 10 may be disposed adjacent to the cap 1300 and the second end 1204 of the elongate member 1200.

[0103] 11A, the delivery system 1000 can include multiple guide members 1400a, 1400b, and 1400c. The guide members 1400a, 1400b, and 1400c are coupled (e.g., releasably coupled) to the delivery system 1000 proximate the second end 1204 of the elongate member 1200. For example, in some embodiments, the guide members 1400a, 1400b, and 1400c are coupled to the cap 1300. Each of the guide members 1400a, 1400b, and 1400c can form a loop 1402 (one of which is referenced in FIG. 11A for ease of illustration) that can be secured to or disposed around at least a portion of the cap 1300. In other embodiments, guide members 1400a, 1400b, 1400c can implement a coupling system (not shown) for coupling guide member 1400 to delivery system 1000 near second end 1204 of elongate member 1200, the coupling system including a feature such as a ball tip that is received by a corresponding feature proximate second end 1204 of elongate member 1200 (e.g., cap 1300 positioned proximate second end 1204 of elongate member 1200 can include a corresponding feature). Other example embodiments for mating engagement or coupling of guide members 1400a, 1400b, 1400c at the end of delivery system 1000 proximate second end 1204 of elongate member 1200 can be achieved by various coupling configurations including press fit, threaded, ball and detent, articulating clip or jaw, hook and loop, and magnetic. Any number of methods and structures can be implemented to secure guide members 1400a, 1400b, 1400c adjacent second end 1204 of elongate member 1200, and the disclosed embodiments are not intended to limit the scope of the present disclosure. It is also understood that guide member 1400 can be secured at various other locations on delivery system 1000. For example, in some embodiments, guide member 1400 can be secured to elongate member 1200 or other portions of delivery system 1000.In some embodiments, guide member 1400 is secured to the inner wall of main body 100 (e.g., by releasable sutures). In some embodiments, guide member 1400 can be held in place via a lockwire retainer 1902, described in more detail below. Lockwire retainer 1902 may be implemented solely to capture guide member 1400, or may be used in combination with other members for various other purposes, including, but not limited to, steering main body 100 and positioning at a target site, as described below. Further examples for coupling guide member 1400 to delivery system 1000 are provided below and discussed with respect to FIGS. 27A-27C.

[0104] 11B , in some embodiments, a guide member retainer 1980 can be implemented on the guide member 1400 to retain the guide member 1400 during delivery of the implantable device 10 and advancement of the sheath 1600 along the guide member 1400. For example, as shown in FIG. 11B , a delivery system 1000 includes an elongate member 1200 having a first end 1202. At the first end 1202, the delivery system includes a lockwire retainer 1902 and an end cap 1300 (e.g., the lockwire retainer 1902 is disposed between the end cap 1300 and the first end 1202 of the elongate member 1200). The main body 100 is disposed around the elongate member 1200, with the second region 3002 of the main body 100 partially deployed and the first region 3000 restrained. The guide members 1400 extend through the side branch portal 110 toward the first end 1202 of the elongate member 1200. The guide members 1400 include a retention member (e.g., loop 1402) at the end of each guide member 1400. The guide member retainer 1980 is releasably coupled to the lockwire retainer 1902 and extends along the elongate member 1200. The guide member retainer 1980 is operable to retain the guide member 1400 at or near the first end 1202 of the elongate member 1200 (e.g., near the lockwire retainer 1902, the cap 1300, etc.). The guide member retainer 1980 can be releasably coupled to the delivery system 1000 in the coupled position, for example, can be releasably and selectively coupled to the lockwire retainer 1902. Guide member retainer 1980 can capture, trap, or otherwise hold guide members 1400 in a longitudinal position relative to elongate member 1200, thereby limiting guide members 1400 from retracting along the longitudinal length of elongate member 1200. For example, guide member retainer 1980 can be fixedly coupled to an end (e.g., loop 1402) of each guide member 1400, thereby limiting guide members 1400 from retracting when guide member retainer 1980 engages lockwire retainer 1902.The location at which guide member retainer 1980 engages guide member 1400 is generally between lockwire retainer 1902 and side branch portal 110 .

[0105] In some embodiments, guide members 1400a, 1400b, 1400c can implement a coupling system for coupling guide member 1400 to guide member holder 1980 proximate second end 1204 of elongate member 1200, the coupling system comprising, for example, a feature, such as a spherical tip, that is received by a corresponding member of guide member holder 1980. For example, guide member holder 1980 can receive the spherical tip of guide member 1400 through an aperture or loop, where the diameter of the spherical tip of guide member 1400 is larger than the diameter of the aperture or loop of guide member holder 1980. Other example embodiments for mating engagement or coupling of guide members 1400a, 1400b, 1400c at the end of delivery system 1000 proximate second end 1204 of elongate member 1200 can be achieved by a variety of coupling configurations, including press fits, threads, ball and detents, articulating clips or jaws, hook and loop, and magnetic configurations. Any number of methods and structures can be implemented to secure guide members 1400a, 1400b, 1400c proximate second end 1204 of elongate member 1200, and the disclosed embodiments are not intended to limit the scope of the present disclosure. In some embodiments, multiple guide member holders 1980 can be implemented, each operable to hold a corresponding guide member 1400. Thus, each guide member 1400 can be independently held near first end 1202 of elongate member 1200 and released from engagement. Once the guide member 1400 is released, it can be removed from the corresponding side branch portal 110 .

[0106] In some embodiments, guide members 1400 may be directly coupled to lock wire retainer 1902. Guide member retainer 1980 and guide members 1400 may be selectively released from lock wire retainer 1902 (either directly or indirectly from lock wire retainer 1902). Each of guide members 1400 may be selectively retained collectively or individually.

[0107] 11C , in various embodiments, the delivery system 1000 can include a lock wire 1900. In such embodiments, the lock wire 1900 can secure one or more steering lines 1850 to the catheter assembly. For example, referring to FIG. 11C , the delivery system 1000 includes an elongate member 1200, an implantable device 10, at least one steering line 1850, and a lock wire 1900. The lock wire 1900 passes through the elongate member 1200 from outside the patient's body and exits at a point near the cap 1300. In some embodiments, at this point, the lock wire 1900 interacts with the steering line 1850 and then re-enters the elongate member 1200 and continues into the cap 1300. In some embodiments, the lock wire 1900 is coupled to a lock wire retainer 1902 (see also FIG. 1 ), which is disposed at the second end 1204 of the elongate member 1200, for example, between the cap 1300 and the implantable device 10. In such a configuration, the lock wire 1900 releasably secures the steering line 1850 to the delivery system 1000. Any manner in which the lock wire 1900 can interact with one or more steering lines 1850 to maintain a releasable coupling between the one or more steering lines 1850 and the delivery system 1000 is within the scope of the present disclosure.

[0108] In various embodiments, each steering line can further include an end loop. For example, each steering line 1850 includes an end loop. A lock wire 1900 can pass through each end loop to secure each steering line 1850 to the delivery system 1000. Any method of securing one or more steering lines 1850 to the delivery system 1000 is within the scope of the present invention.

[0109] In various embodiments, the locking wire can be formed from metals, polymers, or materials, including conventional medical-grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethyl methacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, stainless steel, cobalt chromium alloys, metals such as Nitinol, etc. The elongate member or locking wire can also be formed from high-strength polymer fibers, such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.).

[0110] In various embodiments, a catheter assembly used to deliver an expandable implant includes a catheter shaft, an expandable implant, one or more sleeves, one or more steering lines, and a lock wire. In this configuration, the expandable implant can bend to conform to the curvature of a patient's vasculature through tension and corresponding displacement applied to one or more steering lines. Tension can be applied to the steering lines 1850 to cause the expandable implantable device 10 to bend as desired. For example, the implantable device 10 can be bent in a direction aligned with the position of the steering lines 1850. Once the implantable device 10 has bent sufficiently, a constant tension is applied to the steering lines 1850 to maintain the degree of bend. In another example, the device 10 is configured to remain bent according to the tension in the steering lines 1850 in the absence of a straightening force.

[0111] In various embodiments, tension can be applied to the steering line 1850 by pulling on the steering line 1850 from outside the patient's body. In other embodiments, the steering line 1850 can be connected to one or more dials or other mechanisms to apply tension to the rear end of the elongate member 1200. In this configuration, the dials can be used to apply the desired tension and to maintain the correct amount of tension when the desired bend angle of the implantable device 10 is achieved. Various embodiments can also include indicators, scales, gradients, etc. that indicate the amount of tension or displacement in the steering line and / or the amount of bend in the implantable device. In various embodiments, the catheter assembly can include one or more additional markings (e.g., on the handle) that allow the user to determine the orientation of the steering line relative to the vasculature.

[0112] After a sufficient degree of bending is achieved in the implantable device 10, the implant can be rotated for final positioning within the treatment region of the vasculature. In various exemplary embodiments, the lock wire 1900 is engaged with the steering line 1850 such that torsional rotation of the catheter shaft rotates the implantable device 10 within the vasculature. However, any configuration of the delivery system 1000 that allows for rotation of the implantable device 10 is within the scope of the present disclosure.

[0113] After the implantable device 10 is in place and expanded within the vasculature, the lock wire 1900 can be detached from the delivery system 1000. In various embodiments, the lock wire 1900 is detached by applying sufficient tension to the lock wire 1900 from outside the patient's body. After the lock wire 1900 is released, the steering line 1850 is released from its connection to the elongate member 1200 and can be removed from the implantable device 10 and delivery system 1000.

[0114] 11A , guide members 1400a, 1400b, 1400c each extend through a respective side branch portal 110 of the main body 100 of the implantable device 10. Cannulation of the side branch portal 110 occurs prior to inserting the implantable device 10 into the patient through the access site. Pre-cannulation can reduce procedure time, simplify steps performed during surgery, and reduce trauma to the patient's tissue and damage to the implantable device 10. Guide members 1400a, 1400b, 1400c extend through the side branch portal 110 and through the second opening 109 of the main body 100 of the implantable device 10. Thus, guide members 1400a, 1400b, 1400c can be positioned within the main lumen 102 of the implantable device 10 from the side branch portal 110 to the second end 108 of the main body 100 of the implantable device 10. Guide members 1400a, 1400b, 1400c extend from second opening 109 toward second end 1204 of elongate member 1200. In some embodiments, guide members 1400a, 1400b, 1400c are routed through handle 1100 (see FIG. 1 ), while in other embodiments, guide members 1400a, 1400b, 1400c are routed through other ports (not shown). Guide members 1400a, 1400b, 1400c may extend along the outside of elongate member 1200, or guide members 1400a, 1400b, 1400c may extend through the elongate member (not shown). A wire management device (not shown) may be implemented to reduce tangling or crossing of guide members 1400a, 1400b, 1400c. For example, the wire management device minimizes the interaction of the multiple guidewires and / or guide members with each other and with other components of the delivery system 1000 to limit or prevent tangling, entanglement, and / or interference between the guidewires and / or guide members or between the guidewires and / or guide members and other components of the delivery system 1000, which would hinder the advancement of the device along the guidewires and / or guide members.The wire management device maintains each of the guidewires and / or guide members in a predetermined position. The wire management device is operable to release a portion of the guidewire and / or guide member as the device advances along the longitudinal length of the wire management device, allowing the device and its branches to advance through the patient's lumen. For example, the delivery system 1000 can include a wire management device that releasably houses multiple guidewires and / or guide members. The wire management device can be configured to release a first portion of at least one of the guidewires and / or guide members as the device is advanced along the main guidewire 1500 and to release a second portion of the guidewire and / or guide member as the device is advanced along the main guidewire 1500 to a second longitudinal position. Thus, the wire management device gradually (also described as stepwise, inch-by-inch, or sequential) releases the guidewire as the device is advanced relative to the delivery system 1000, thereby properly positioning the guidewire to interact with the device (e.g., passing through the lumen of the device) upon delivery of the device.

[0115] 12 , the implantable device 10 can be at least partially expanded. For example, the main body 100 can be partially expanded from a first constrained diameter to a second partially constrained diameter that is larger than the first diameter. As shown in FIG. 12 , the main body 100 can also include a first region 3000 and a second region 3002. The first region 3000 extends from the first end 106 of the side branch portal 110 to the second opening 121, and the second region 3002 extends from the second opening 121 of the side branch portal 110 to the second end 108 of the main body 100. The division point between the first region 3000 and the second region 3002 can be defined at slightly different locations (e.g., generally within about 3 cm of the side branch portal 110). In some embodiments, the first region 3000 and the second region 3002 can be independently constrained and / or deployed. For example, as shown in FIG. 12 , the second region 3002 is partially deployed to a second partially constrained diameter, while the first region 3000 is maintained at the first constrained diameter. By partially deploying the second region 3002, the side branch portal 110 is operable to at least partially expand. Such constraining members and staged deployments include, but are not necessarily limited to, the primary and secondary sleeves of the constraining member 1800. The primary and secondary sleeves may be used in series, and releasing one of the primary and secondary sleeves allows for partial or partial expansion of the main body 100. This allows access through the side branch portal while simultaneously maneuvering the main body 100 to the target site. Furthermore, by maintaining the first region 3000 in the first constrained configuration, access through the second opening 121 of the side branch portal 110 is not reconfigured or blocked by the first region 3000 of the main body 100. This also facilitates access to a branch lumen (e.g., the brachiocephalic artery 24).

[0116] 13a-13c, for example, a sheath 1600 is provided for each guide member 1400. With first, second, and third guide members 1400a, 1400b, and 1400c for first, second, and third side branch portals 110a, 110b, and 110c, first, second, and third sheaths 1600a, 1600b, and 1600c (see FIG. 15) are provided for each corresponding side branch body 200 and guide member 1400. Each sheath 1600 is operable to advance along each corresponding guide member 1400. The sheaths 1600 can be configured to move along the guide members 1400 by surrounding the guide members 1400, by using the guide members as side-by-side rails, or by allowing the sheaths 1600 to move substantially along the path of the guide members 1400. Side branch portal 110 is pre-cannulated with guide members 1400a, 1400b, 1400c so that sheath 1600 can be advanced through second opening 109 in the elongate member and exit through second opening 121 in side branch portal 110. For example, first end 1602 of sheath 1600 can be advanced through the patient's vasculature and exit through second opening 121 in side branch portal 110. First end 1602 can be positioned near a corresponding branch of the vasculature (e.g., the brachiocephalic artery).

[0117] In some embodiments, the sheath 1600 includes a lumen through which the articulatable secondary guide member or catheter 1700 can be inserted (e.g., the same lumen through which the guide member 1400 passes). A variety of secondary articulatable members or catheters 1700 can be implemented, including, but not limited to, steerable catheters and guidewires. For example, the articulatable secondary member or catheter 1700 can be steered using at least one tether or tensioning member (not shown) coupled to the distal end of the articulatable guidewire 1700 (the articulatable guide member or catheter 1700 can be an integral unit or a composite of various components to provide articulation functionality, e.g., a guide catheter and guidewire). The articulatable guide member or catheter 1700 can be steered by applying tension to the tether or tensioning member. Multiple tethers and / or tensioning members can be used to achieve various degrees of movement. Other embodiments include robotic or motor-driven guidewires. Various embodiments of articulatable guidewires can be implemented in the delivery system 1000 and method. An articulatable secondary guide member or catheter 1700 is advanced through the sheath 1600 to the treatment site. For example, as shown in FIG. 14 , a first articulatable secondary guide member or catheter 1700a is advanced through the first sheath 1600a through the first side branch portal 110a to the target site. The articulatable secondary guidewire 1700 includes a forward end that can be articulated by the user at the rear end (not shown). The forward end can be bent or articulated to various configurations and positions. Once the forward end of the first articulatable secondary guide member or catheter 1700a is released from the first sheath 1600a, the user can articulate the forward end of the first articulatable secondary guide member or catheter 1700a to a position within the target branch (e.g., the brachiocephalic artery) corresponding to the first side branch portal 110a. Once the secondary guide element or catheter 1700a is in place, the guidewire 1702 can be advanced into position (eg, through the secondary guide element or catheter 1700a).This process is repeated for each branch and corresponding side branch portal 110 with a subsequent articulatable secondary guide member or catheter 1700. Referring to FIG. 15 , a guidewire 1702 can be advanced through a filter 2002 deployed within the branch. Further, the guidewire 1702 can be advanced so that the guidewire 1702 extends outside the filter access site, creating a through-configuration for the guidewire 1702. FIG. 16 illustrates each branch (e.g., the brachiocephalic trunk, left common carotid artery, and left subclavian artery 24, 25, 26) cannulated with a corresponding articulatable secondary guidewire 1700, which extends through the corresponding side branch portal 110.

[0118] Referring now to FIG. 17 , the first region 3000 is partially deployed to a second, partially constrained diameter. As the first region 3000 is partially deployed, the entire main body 100 is partially deployed to the second, partially constrained diameter. At this stage, the main body 100 can be adjusted to the appropriate position within the target site to facilitate optimal placement and performance of the implantable device 10. Once the desired positioning of the main body 100 is achieved, the main body 100 can be deployed to a third deployed diameter (e.g., unconstrained by the constraining member 1800). As shown in FIG. 18 , once the main body 100 is fully deployed, portions of the delivery system 1000 can be removed, including the elongate member 1200 and cap 1300, at least one guide member 1400, at least one sheath 1600, and the constraining member 1800. As described above, the guide member 1400 can be released, which can occur at this point in the procedure. In some embodiments, the main guidewire 1500 can also be removed. This leaves the main body 100 at the target site along with the secondary articulatable guidewire 1700 cannulating the corresponding side branch portals 110 and branches (e.g., the brachiocephalic trunk, left common carotid artery, and left subclavian arteries 24, 25, 26).

[0119] Referring to FIG. 19 , the branch body 200 can be advanced along a corresponding secondary articulatable guidewire 1700. The branch body 200 can be advanced on a separate component similar to the component used to deliver the main body 100, such as, for example, an elongate member 4000 with an end cap 4002. In some embodiments, the end cap 4002 or other separate component can expand the side branch portal 110 as the branch body 200 passes through it. The branch body 200 is positioned such that the first portion 202 is at least partially positioned within the branch at the target site and the second portion is positioned within the implantable device 10 (e.g., within the side branch portal 110). Once the branch body 200 is properly positioned, it is deployed, as shown in FIG. 20 . Referring to FIG. 21 , the elongate member 4000 and end cap 4002 used to deliver the branch body 200 are removed. FIG. 22 illustrates suctioning the filtration system 2000. Once filtration system 2000 is aspirated, filtration system 2000 can be removed, as shown in Figure 23. The remaining components (e.g., primary guidewire 1500 and secondary articulatable guidewire 1700) can be removed from the patient, and the surgeon can begin closure.

[0120] 25-28, in some embodiments, another embodiment of the device 10 is provided with multiple selectable side branch portals 510. FIG. 25 shows a side view of an example implantable device 10 having a main body 500 and multiple selectable side branch portals 510 extending therethrough. The implantable device 10 also includes a side branch 502 extending from the main body 500 through the selectable side branch portal 510. The side branch 502 is separate from the main body 500 (i.e., the side branch 502 is not integral with the main body 500). Because the side branch 502 is a separate structure from the main body 500, the side branch 502 is coupled to the main body 500 to form the implantable device. For example, the main body 500 can be positioned in the abdominal aorta, and the side branch 502 can be deployed in a renal artery and extend into the main body 500 located in the abdominal aorta.

[0121] As shown in FIG. 26A , in some embodiments, the main body 500 of the implantable device 10 includes a tubular member 520 and a stent member 540. As shown, the tubular member 520 has a first end 522 and a second end 524. The tubular member 520 forms a main lumen 526 having a first opening 523 at the first end 522 of the tubular member 520 and a second opening 525 at the second end 524 of the tubular member 520. The tubular member 520 includes a side branch portal 510 including a column 528 disposed within the main lumen 526, forming a secondary lumen 530 (see FIG. 26B ). The tubular member 520 defines an aperture 532 into the secondary lumen 530 at a longitudinal location between the first end 522 and the second end 524 of the tubular member 520. Column 528 defines a column opening 534 (see FIG. 26B) proximal to the second end of tubular member 520. Stent member 540 supports tubular member 520 such that the implantable device is operable to be configured into and transitioned from a delivery configuration and a deployed configuration.

[0122] In some embodiments, the tubular member 520 includes a first graft member 541 that defines a main lumen 526 and a second graft member 542 that is coupled to the first graft member 541, forming a column 528 that defines a secondary lumen 530 between the first graft member 541 and the second graft member 542. For example, the first graft member 541 includes graft material formed into a tubular shape to define the main lumen 526. The second graft member 542 optionally includes graft material that is coupled to the first graft member (e.g., by bonding, adhesively, or otherwise bonding together) to form the secondary lumen 530. The graft materials of the first and second graft members 541, 542 may be the same or different materials, as desired. A variety of suitable graft materials may be implemented, and generally any suitable graft material may be implemented, including those discussed herein, although some materials may offer certain advantages over other materials.

[0123] In some embodiments, the secondary lumen 530 extends at least partially along the longitudinal length of the main body 512. The secondary lumen 530 of the column 528 opens into the main lumen 526 at a proximal opening of the secondary lumen 530. In some embodiments, the column 528 extends to the second end 524 of the tubular member 520 such that the column opening 534 is located at or flush with the second opening 525 of the tubular member 520. In other embodiments, the column 528 extends toward the second end 520 of the tubular member 520 such that the column opening 534 is longitudinally spaced from the second opening 525 of the tubular member 520. In embodiments including multiple columns 528, the column openings 534 may be positioned at the same longitudinal length across the tubular member 520, or in other words, at the same longitudinal position along the tubular member 520, or may be offset at two or more longitudinally spaced positions along the length of the tubular member 520.

[0124] In some embodiments, columns 528, and therefore secondary lumen 530, are collapsible. For example, columns 528 may not be supported by a stent member, although supported collapsible embodiments are contemplated. A lack of support, or appropriately configured support, can cause columns 528 to collapse (collapse radially) and seal aperture 532, restricting leakage or other passage of fluid (e.g., blood) through aperture 532. In some embodiments, pressure exerted by the fluid (e.g., static pressure, fluid pressure gradient, and / or pressure exerted by a moving fluid) collapses columns 528 such that the columns seal or seal against tubular member 520, restricting fluid passage through secondary lumen 530 and, therefore, aperture 532.

[0125] As shown in FIG. 26A , the column 528 can be sealed or closed near the first end 522 of the tubular member 520, or in some embodiments not shown, at the first end 522. In this manner, the secondary lumen 530 is operable to provide fluid communication between the outer surface of the tubular member 520 between the first and second ends 522, 524 and the main lumen 526, for example, when the column 528 is patent. In some embodiments, the tubular member 520 can include an unsealed (i.e., opening) column 528 near the first end of the tubular member 520. In such embodiments, an elongate member, such as a delivery catheter, can be positioned through the column 528. Referring to FIG. 26B , an end view of the main body 512 is shown, with the column opening 534 located proximate the second end 524 of the main body 512. In some embodiments, the column 528 extends to the second end 524 of the main body 512. As shown, the secondary lumen 530 can be contained within the main lumen 526 .

[0126] Referring again to FIG. 26A , main body 512 includes stent member 540. Stent member 540 can be formed from any suitable material, as discussed below. Stent member 540 is operable to support tubular member 520. Stent member 540 can be compressed into a delivery configuration and expanded to an expanded configuration, such as during deployment. Stent member 540 can be a self-expanding stent or a balloon-expandable stent. As shown, stent member 540 includes a plurality of stent rings 544. Each stent ring 544 circumferentially supports tubular member 520 at a longitudinal position along the length of tubular member 520. For example, each stent ring 544 is longitudinally spaced from an adjacent stent ring 544. Each stent ring 544 can include an apex 546 with a first apex 546 a toward first end 522 and a second apex 546 b toward second end 524. Various other configurations of stent member 40 are contemplated herein, including, but not limited to, helical stents (including wavy helical stents, diamond pattern stents, etc.).

[0127] 26A, the tubular member 520 includes a plurality of apertures 532 spaced apart along the longitudinal length of the main body 512. The apertures 532 can be arranged such that at least one stent ring is between two longitudinally adjacent apertures 532. For example, the column 528 can include apertures 532 through the tubular member 520 such that the apertures 532 are spaced apart longitudinally along the main body 512. The apertures are all in fluid communication with the secondary lumen 530 of the column 528. The apertures 532 provide access points for secondary branches at various longitudinal lengths along the main body 512.

[0128] 26C , apertures 532 can be formed in a variety of shapes and sizes, including circular profiles, profiles with rounded and substantially flat edges, oval profiles, etc. The various shapes and sizes can be implemented to accommodate various side branches 502 and configurations, such as the angle of exit of the side branches 502 from the main body 512 at the apertures 532. In some embodiments not shown, apertures 532 can be irregularly spaced along the longitudinal length of column 528. Further, in some embodiments not shown, apertures 532 can be circumferentially spaced within column 528. For example, apertures 532 can be circumferentially and / or longitudinally offset.

[0129] In some embodiments, the main body 512 can include multiple columns 528. For example, the main body 512 can include two circumferentially spaced columns 528 for deploying two side branches 514 within side branch lumens of the patient's anatomy. Additionally, the main body 512 can include multiple columns 528 associated with each side branch lumen of the patient's anatomy. For example, if the main body 512 is positioned in the abdominal aorta and the side branches 514 are positioned in the renal arteries, each patient can have different circumferential locations where the renal arteries enter the aorta.

[0130] By having multiple columns 528 into which each side branch 514 can be deployed, the surgeon can select the appropriate columns 528 that best fit the patient's native anatomy without adding kinks to the vessel when the implantable device 10 is deployed. Thus, in one example, the main body 512 includes three columns 528 on one circumferential side of the tubular member 520 and three more columns 528 on the opposite circumferential side of the tubular member 520. Each column 528 is circumferentially spaced from an adjacent column around the tubular member 520. It is contemplated that any number of columns 528 and spacing between columns 528 can be implemented, including one, two, three, four, five, six, seven, eight, or more columns 528, which can be equally or variably spaced around the tubular member 520. It is further contemplated that a particular spacing can be determined by examining the average circumferential spacing of side branches for a particular implementation in a sample population of patients to determine the spacing between columns 528. The circumferential spacing of the columns 528 allows for clocking of the main body 512 within the patient's anatomy at incremental positions to properly position the side branch 514 within the side branch vessel. As used herein, the term "clocking" refers to the ability to position a feature at a desired location around an object. This ability to clock one or more columns 528 can be further advantageous for use with visualization, for example, when a procedure is performed via fluoroscopy. This simplifies placement by providing several entry points when dealing with the two-dimensional plane depicted by the visualization technique and the parallax associated with such visualization. In some embodiments, the columns 528 may be irregularly spaced around the main body 512 (e.g., non-uniform spacing between the columns 528). In some embodiments not shown, the columns 528 are longitudinally oriented at an angle greater than zero relative to the longitudinal axis of the main body 512. For example, secondary lumen 530 extends along a secondary lumen axis that extends longitudinally (eg, helically around main body 512 ) at an angle greater than zero relative to the axis of main lumen 526 .

[0131] 26A , the main body 512 can include restraining member receivers 50 positioned to surround at least a portion of the stent member 40. For example, in embodiments including multiple stent rings 544, a corresponding restraining member receiver 550 is positioned around each stent ring 544. The restraining member receivers 550 can be formed from a variety of materials, including graft material, fabric, etc. The restraining member receivers 550 are operable to receive restraining members that can be retracted to partially restrain or collapse the stent rings 544, as described below.

[0132] In some embodiments, the tubular member 520 can include a scallop 552 at the first end 522. The scallop 552 facilitates placement of the tubular member 520 within a lumen, including a side branch lumen, that does not require a prosthetic side branch to be deployed. For example, when the implantable device 10 is positioned within the abdominal aorta and the superior mesenteric artery does not require a side branch 514 to be deployed therein, the scallop 552 can be positioned over the entrance to the superior mesenteric artery without blocking or restricting blood perfusion through the superior mesenteric artery. The scallop 552 can include a variety of shapes, including straight edge profiles, curved profiles, and combinations thereof.

[0133] 27A-27C, a catheter olive or cap 1300 is positioned on a first end of the elongate member 1200 such that the main body 512 of the implantable device 10 is longitudinally disposed between the cap 1300 and the second end of the elongate member 1200. While an embodiment of the cap 1300 is shown in the drawings, it is within the scope of this disclosure that any catheter olive or cap may be implemented. The cap 1300 may be implemented to atraumatically advance the delivery system 1000 through the patient and, if necessary, dilate the surrounding anatomy. For example, the cap 1300 may include a forward end that is initially advanced through the patient's anatomy. Referring to FIGS. 27A-27C, the cap 1300 may include a guide member retainer 1302. However, the guide member retainer 1302 may include a passageway through which the guide member 1400 passes (see FIG. 27A). In this embodiment, the guide member 1400 can extend through the cap 1300 and back through an aperture 532 in another, opposing column 528. The guide member retainer 1302 can be operable to releasably retain a lock wire 1900, to which the guide member 1400 can be coupled (see FIG. 27B). The lock wire 1900 can be controlled via a lock wire lumen. The guide member retainer can be operable to receive and releasably retain an end of the guide member 1400, for example, via a friction fit or other coupling (see FIG. 27C). Various embodiments of the cap 1300 can be implemented specifically to couple the guide member 1400 (e.g., the guide member retainer 1302). Such embodiments include those discussed in U.S. Patent Publication No. 2020 / 0046534, filed August 13, 2019, by Chung et al., the contents of which are expressly incorporated herein by reference. In some embodiments, the cap 1300 may be curved to facilitate clocking of the device 10 as it advances from the implant procedure to the target site.

[0134] Although the method is disclosed with reference to the aorta 20, the systems and methods described herein may be implemented in a variety of lumens where bifurcations occur.

[0135] Catheters, introducer sheaths, hubs, handles, and other components usable in the medical device delivery systems and methods disclosed herein can be constructed using any suitable medical-grade material or combination of materials and any suitable manufacturing process or tooling. Suitable medical-grade materials include, for example, nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethyl methacrylate, polypropylene, polytetrafluoroethylene, expanded polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, Pebax® polyether block amide, and metals such as stainless steel and nitinol. Catheters can also include a reinforcing member, such as a layer of metal braid.

[0136] 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 a combination thereof. In some examples, bioresorbable or bioabsorbable materials, such as bioresorbable or bioabsorbable polymers, can be used. In some examples, the graft can include Dacron, polyolefin, carboxymethylcellulose fabric, polyurethane, or other woven, nonwoven, or film elastomers.

[0137] It is understood that any of the system components may also include radiopaque markers to facilitate fluoroscopic viewing during the implant procedure. Any number, shape, and location of radiopaque markers may be utilized as desired.

[0138] The delivery systems and methods disclosed herein are particularly suited for the endoluminal delivery of bifurcated expandable implants for treating bifurcated vasculature. Expandable implants can include, for example, stents, grafts, and stent-grafts. Additionally, expandable implants can include one or more stent components with one or more graft members disposed above and / or below the stent, which can expand from a delivery configuration, through larger intermediate configurations, to a deployed configuration in engagement with the vessel wall at the treatment site. However, as discussed below, any suitable combination and configuration of stent components and graft members is within the scope of the present disclosure. For example, stent components can have a variety of configurations, such as rings, cut tubes, wound wire (or ribbons), or flat patterned sheets wound into a tubular shape. Stent components can be formed from metallic, polymeric, or natural materials and can include conventional medical-grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethyl methacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, metals such as stainless steel, cobalt-chromium alloys, and nitinol, and bio-derived materials such as bovine arteries / veins, pericardium, and collagen. Stent components can also include bioresorbable materials such as poly(amino acids), poly(anhydrides), poly(caprolactone), poly(lactic / glycolic acid) polymers, poly(hydroxybutyric acid), and poly(orthoesters).

[0139] Further, potential materials for the graft member include, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers such as perfluoroelastomers, polytetrafluoroethylene, silicone, urethane, ultra-high molecular weight polyethylene, aramid fibers, and combinations thereof. Other embodiments of the graft member material can include high-strength polymer fibers, such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). The graft member can include a bioactive agent. In one embodiment, the ePTFE graft includes a carbon component along its blood-contacting surface. Any graft member that can be delivered by a catheter is in accordance with the present disclosure.

[0140] Additionally, while nitinol (NiTi) may be used as the frame or stent (and any of the frames discussed herein) material, other materials, such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other suitable biocompatible material and combinations thereof, may be used as the frame material. The superelastic properties and softness of NiTi may 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 to a desired shape when unconstrained, such as when the frame is deployed from a delivery system. Other materials, including, but not limited to, NiTiCo, may also be used as needed.

[0141] The invention of this 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 come within the scope of the appended claims and their equivalents.

[0142] Any of a variety of bioactive agents may be implemented with any of the above. For example, any one or more (including portions thereof) of the implantable device 10 and delivery system 1000 may include a bioactive agent. The bioactive agent may be coated onto one or more of the above-described features for controlled release of the bioactive agent. 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 of the ability 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., estrogen), 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), fibrinolytic agents (e.g., plasminogen activators, streptokinase and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abcizimab, 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 gold sodium 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. The delivery systems and methods according to various embodiments disclosed herein can utilize a removable guidewire to preserve a branch portal for guidewire intubation after compressing the expandable implant into a delivery configuration for intraluminal delivery to the treatment site. The removable guidewire tube can include the same materials listed above for the catheter.

[0143] Many 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 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, shape, size, and arrangement 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 spirit and scope of the appended claims. In addition to the embodiments described above and claimed below, the present invention is also directed to embodiments having different combinations of the features described above and claimed below.

[0144] The invention of this 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 come within the scope of the appended claims and their equivalents.

Claims

1. 1. A method of deploying a multi-branched stent graft at a target site having a main lumen and a first branch lumen, the method comprising: advancing the main guidewire to the target site; advancing a catheter including a multi-branch stent graft main body along the main guidewire toward a main lumen of a target site, wherein the main body has a first portion and a second portion, and wherein the main body defines 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, the first portal having the first secondary guidewire pre-cannulated therein prior to advancing the main body along the main guidewire; partially deploying the second portion of the main body within the main lumen of the target site; advancing a first sheath through the first portal along a first guide member; advancing a first articulatable guide catheter through the first sheath; positioning the first articulatable guide catheter within a first branch lumen of the target site; partially deploying the first 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 guide catheter into the first branch lumen at the target site; and deploying the first side branch body within the first branch lumen at the target site; A method comprising:

2. The method of claim 1 , further comprising deploying an embolic filter within the first branch lumen at the target site.

3. The method of claim 2 , further comprising aspirating a filter sheath of the embolic filter.

4. The method of claim 3 , further comprising removing the embolic filter after the first side branch body is deployed.

5. 10. A method according to any one of the preceding claims, wherein the first guide member is held adjacent the first end of the elongate member.

6. 10. The method of any one of the preceding claims, wherein the main body further defines second and third portals operable to provide fluid access from the main body to second and third side branches extending from the target site when the main body is deployed at the target site, the second portal being pre-cannulated with a second guide member and the third portal being pre-cannulated with a third guide member prior to advancing the main body along the main guidewire.

7. advancing a second sheath through the second portal and along the second guide member; advancing a second articulatable guide catheter through the second sheath; positioning the second articulatable guide catheter within a second branch lumen of the target site; advancing a third sheath through the third portal and along the third guide member; advancing a third articulatable guide catheter through the third sheath; and positioning the third articulatable guide catheter within a third branch lumen of the target site; The method of claim 6 further comprising:

8. advancing a second side branch body along the second articulatable guide catheter into the second branch lumen at the target site; deploying the second side branch body within the second branch lumen at the target site; advancing a third side branch body along the third articulatable guide catheter into the third branch lumen at the target site; and deploying the third side branch body within the third side branch lumen at the target site; The method of claim 7 further comprising:

9. The method of claim 8 , further comprising removing the main guidewire, the first, second and third guide members, and the first, second and third sheaths.

10. The method of claim 9 , wherein the catheter is removed before advancing the first, second, and third sheaths.

11. an elongate member having a first end and a second end; an end cap coupled to the first end of the elongate member; an endoprosthesis including a main body defining a main lumen and at least one side branch portal, and at least one second body defining a secondary lumen; at least one guide member extending through the at least one side branch portal and coupled to the end cap; 1. An endoprosthesis delivery system comprising:

12. The endoprosthesis delivery system of claim 11 , further comprising a restraining member that restrains the main body of the endoprosthesis to the elongate member.

13. 13. The endoprosthesis delivery system of claim 12, wherein the restraining member is operable to restrain the main body in a restrained configuration and a partially deployed configuration, the main body having a first diameter in the restrained configuration, a second diameter larger than the first diameter in the partially deployed configuration, and a third diameter larger than the first diameter and the second diameter in the deployed configuration.

14. 14. The endoprosthesis delivery system of claim 13, wherein the restraining member includes a first portion and a second portion, the first portion and the second portion independently operable to restrain corresponding first and second portions of the main body in the restrained configuration and the partially deployed configuration.

15. The endoprosthesis delivery system of any one of claims 11 to 14, further comprising a sheath operable to be advanced along the at least one guide member.

16. The endoprosthesis delivery system of claim 15 , further comprising an articulatable wire or guide catheter operable to be advanced through the sheath.

17. 17. The endoprosthesis delivery system of claim 16, further comprising at least one secondary branch operable to be advanced along the articulatable wire or guide catheter and deployed at least partially within the at least one side branch portal.

18. 18. The endoprosthesis delivery system of claim 17, further comprising a removable filter operable to be deployed downstream from the target site of the endoprosthesis.

19. 20. The endoprosthesis delivery system of claim 18, wherein the removable filter includes a central lumen operable for the articulatable wire or guide catheter to extend therethrough.

20. The endoprosthesis delivery system of any one of claims 11 to 19, wherein the end caps are curved.

21. The endoprosthesis delivery system of any one of claims 11 to 20, wherein the endoprosthesis delivery system curves from the end cap through the main body.

22. an elongate member having a first end and a second end; an endoprosthesis including a main body longitudinally disposed between the first end and the second end of the elongate member, the main body defining a main lumen and a side branch portal; a guide member extending through the side branch portal; and a guide member holder removably coupled to the elongate member at a docking position, the guide member being coupled to the guide member holder at a location between the side branch portal and the docking position of the guide member holder; 1. An endoprosthesis delivery system comprising:

23. 23. The endoprosthesis delivery system of claim 22, wherein the main body defines a plurality of side branch portals.

24. 24. The endoprosthesis delivery system of claim 22 or claim 23, further comprising a plurality of guide members.

25. The endoprosthesis delivery system of any one of claims 22 to 24, wherein the guide member retainers extend through loops formed at each end of the guide members.

26. The endoprosthesis delivery system of any one of claims 22 to 25, wherein the guide member retainer is operable to be selectively disengaged from the first coupling location.

27. The endoprosthesis delivery system of any one of claims 22 to 26, wherein the elongate member includes a lockwire retainer disposed at the first end of the elongate member.

28. 28. The endoprosthesis delivery system of claim 27, wherein the guide member retainer is releasably coupled to the lockwire retainer.

29. 29. The endoprosthesis delivery system of claim 22, further comprising a side branch body, each guide member including a first end, each first end of the guide members being held by the guide member holder between the attachment location and the side branch portal when the side branch body is advanced along the guide members.

30. The endoprosthesis delivery system of any one of claims 22 to 29, wherein each guide member is operable to be removed from a corresponding side branch portal when the guide member retainer is released.

31. The endoprosthesis delivery system of any one of claims 22 to 30, further comprising a plurality of guide member holders, each guide member holder coupled to a corresponding guide member.

32. 30. The endoprosthesis delivery system of claim 29, wherein each guide member holder is operable to be individually and selectively released from engagement at the first docking location such that each guide member is operable to be individually removed from a corresponding side branch portal.

33. 23. The endoprosthesis delivery system of claim 22, wherein the elongate member includes a cap disposed on a first end of the elongate member, and the guide member retainer is coupled to the cap at the coupling location.

34. The endoprosthesis delivery system of any one of claims 22 to 33, wherein the guide member retainer is coupled to the elongate member at the first end of the elongate member.

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