EP4791317A1 - Single access deployment systems for branched vessel treatment - Google Patents

Abstract

The present disclosure relates generally to methods for delivering expandable endoluminal prosthetic devices through a single access site. More specifically, the disclosure relates to methods for placing endoprostheses to treat aneurysmal common iliac arteries.

Description

SINGLE ACCESS DEPLOYMENT SYSTEMS FOR BRANCHED VESSEL TREATMENT

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63/543,373, filed October 10, 2023 , which is incorporated herein by reference in its entirety for all purposes.

FIELD

[0002] The present disclosure relates generally to methods for delivering an endoprosthesis to a treatment location in a body lumen of a patient using a single access site. More specifically, the disclosure relates to single-access site delivery methods for treating branched vessels and associated devices and systems.

BACKGROUND

[0003] Endoluminal devices are used in a variety of places in the human body to support various anatomical lumens, such as blood vessels, respiratory ducts, and gastrointestinal ducts, for example. These endoluminal devices are typically deployed at a desired treatment site to treat maladies such as diseases or defects of the aforementioned anatomical lumens, including vasculature of a patient. Treatment of vascular maladies involving bifurcated lumens can be more challenging than non-bifurcated treatment sites. For example, the abdominal aorta splits at a primary branch into the common iliac arteries, which branch again at opposing secondary branches into the external iliac and internal iliac arteries (or hypogastric arteries). Treatment of such primary and secondary branch anatomy increases procedure complexity with the addition of modular components and associated delivery systems. For example, to address more challenging branched anatomy, modular endoprostheses have been developed that include a main body endoprosthesis and one or more branch endoprostheses that can be assembled with the main body in vivo. In the event the anatomy to be treated includes further bifurcations, endoprosthesis systems including additional modular components may be implemented. For example, G.Oderich et al, “Techniques of Endovascular Aortoiliac Repair Using an Iliac Branch Endoprosthesis” Vol.16, No.8 Aug. 2017 Supplement to Endovasc. Today, describes treatment of complex multi-branch aneurysms using bilateral femoral access in conjunction with a modular endoprosthesis system (including the Gore® Excluder® Iliac Branch Endoprosthesis).

SUMMARY

[0004] This description relates to endoprosthesis delivery systems and methods for delivering endoprostheses to intravascular treatment sites including branched vessels. These methods can be used to treat a range of diseases in branched vessels, including abdominal aortic, common iliac, external iliac and/or internal iliac aneurysms. In various implementations, the delivery systems and methods addressed in this disclosure allow for simplified endoluminal implantation procedures, suitable for complex target sites, such as those extending across branched vascular anatomy with multiple levels of branching. In various examples, these simplified approaches include implanting the endoprostheses using a single access site (e.g., a femoral artery access site).

[0005] According to a first example (“Example 1”), a method of delivering a device to a target vascular location includes advancing a primary endoprosthesis to a location proximate a bifurcation of a main vessel through an external access site in a body of a patient, the primary endoprosthesis including a main body branching into a first leg and a second leg, wherein the main vessel bifurcates into a first branch and a second branch at the bifurcation; deploying the primary endoprosthesis; advancing a guide reversal system from the external access site through the first branch of the main vessel into the first leg of the primary endoprosthesis; advancing a guide member through the external access site through the first branch of the main vessel into first leg of the primary endoprosthesis, and into the main body of the primary endoprosthesis; directing the guide member back into the second leg of the primary endoprosthesis and into the second branch of the main vessel using the guide reversal system; advancing an auxiliary endoprosthesis through the external access site over the guide member and into the second leg of the primary endoprosthesis; and deploying the auxiliary endoprosthesis.

[0006] According to another example (“Example 2”), further to Example 1 , the main vessel is a descending aorta.

[0007] According to another example (“Example 3”), further to Examples 1 or 2, directing the guide member back into the second leg of the primary endoprosthesis and into the second branch of the main vessel using the guide reversal system includes steering the guide member back into the second branch with a steering sheath and/or snaring the guide member with a snare and drawing the guide member back into the second branch with the snare.

[0008] According to another example (“Example 4”), further to any one of Examples 1 to 3, the auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

[0009] According to another example (“Example 5”), further to any one of Examples 1 to 4, the auxiliary endoprosthesis is deployed in the first leg of the primary endoprosthesis to couple the primary endoprosthesis and the auxiliary endoprosthesis.

[00010] According to another example (“Example 6”), further to any one of

Examples 1 to 5, the method further includes directing a second guide member through the external access site and the first branch of the main vessel into the second leg of the primary endoprosthesis.

[00011] According to another example (“Example 7”), further to Example 6, the method further includes advancing a second auxiliary endoprosthesis through the external access site over the second guide member into the second leg of the primary endoprosthesis; and deploying the second auxiliary endoprosthesis in the second leg of the primary endoprosthesis to couple the second auxiliary endoprosthesis and the primary endoprosthesis.

[00012] According to another example (“Example 8”), further to Example 7, the second auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

[00013] According to another example (“Example 9”), further to any one of

Examples 1 to 8, the method further includes directing the guide member back into the second leg of the primary endoprosthesis, through the first leg of the auxiliary endoprosthesis, and into the second branch of the main vessel using the guide reversal system; advancing a third auxiliary endoprosthesis through the external access site, including a main body lumen, over the guide member into the first leg of the auxiliary endoprosthesis; and deploying the third auxiliary endoprosthesis in the first leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the third auxiliary endoprosthesis.

[00014] According to another example (“Example 10”), further to Example 9, the third auxiliary endoprosthesis includes a main body lumen without any branches.

[00015] According to another example (“Example 11 ”), further to any one of

Examples 1 to 10, the method further includes directing the guide member back into the second leg of the primary endoprosthesis, through the second leg of the auxiliary endoprosthesis, and into the second branch of the main vessel using the guide reversal system; advancing a fourth auxiliary endoprosthesis through the external access site over the guide member into the second leg of the auxiliary endoprosthesis; and deploying the fourth auxiliary endoprosthesis in the second leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the fourth auxiliary endoprosthesis.

[00016] According to another example (“Example 12”), further to Example 11 , the fourth auxiliary endoprosthesis includes a main body lumen without any branches.

[00017] According to another example (“Example 13”), further to Example 11 or 12, when including the features of Examples 9 or 10, wherein the fourth auxiliary endoprosthesis and the third auxiliary endoprosthesis are substantially similar.

[00018] According to another example (“Example 14”), further to any one of Examples 7 or 8 or 9 to 13 when including the features of Examples 7 or 8, the method further includes directing the guide member back into the first leg of the primary endoprosthesis, through the first leg of the second auxiliary endoprosthesis, and into the first branch of the main vessel using the guide reversal system; advancing a fifth auxiliary endoprosthesis through the external access site over the guide member into the first leg of the second auxiliary endoprosthesis; and deploying the fifth auxiliary endoprosthesis in the first leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the fifth auxiliary endoprosthesis.

[00019] According to another example (“Example 15”), further to Examples 14, the fifth auxiliary endoprosthesis includes a main body lumen without any branches.

[00020] According to another example (“Example 16”), further to any one of Examples 7 or 8 or 9 to 15 when including the features of Examples 7 or 8, the method further includes directing the guide member back into the first leg of the primary endoprosthesis, through the second leg of the second auxiliary endoprosthesis, and into the first branch of the main vessel using the guide reversal system; advancing a sixth auxiliary endoprosthesis through the external access site over the guide member into the second leg of the second auxiliary endoprosthesis; and deploying the sixth auxiliary endoprosthesis in the second leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the sixth auxiliary endoprosthesis.

[00021] According to another example (“Example 17”), further to Example 17, the sixth auxiliary endoprosthesis includes a main body lumen.

[00022] According to another example (“Example 18”), a delivery system for delivering a device to a target vascular location through a single external access site includes: a primary endoprosthesis configured for implantation at a location proximate a bifurcation of a main vessel into a first branch and a second branch through an external access site in a body of a patient, the primary endoprosthesis including a main body branching into a first leg and a second leg; a guide member advanceable through the external access site through first branch of the main vessel into first leg of the primary endoprosthesis, and into the main body of the primary endoprosthesis; a guide reversal system advanceable from the external access site through the first branch of the main vessel into the first leg of the primary endoprosthesis and configured to direct the guide member back into the second leg of the primary endoprosthesis and into the second branch of the main vessel; and an auxiliary endoprosthesis advanceable through the external access site over the guide member and into the second leg of the primary endoprosthesis.

[00023] According to another example (“Example 19”), further to Example 18, the primary endoprosthesis is configured for implantation through the external access site into a descending aorta.

[00024] According to another example (“Example 20”), further to Examples 18 or 19, the system further includes a steering sheath and/or a snare configured to direct the guide member back into the second leg of the primary endoprosthesis and into the second branch of the main vessel.

[00025] According to another example (“Example 21”), further to any one of Examples 18 to 20, the auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

[00026] According to another example (“Example 22”), further to any one of Examples 18 to 21 , the auxiliary endoprosthesis is deployable through the external access site into the first leg of the primary endoprosthesis to couple the primary endoprosthesis and the auxiliary endoprosthesis.

[00027] According to another example (“Example 23”), further to any one of Examples 18 to 22, the system further includes a second guide member that is directable through the external access site and the first branch of the main vessel into the second leg of the primary endoprosthesis.

[00028] According to another example (“Example 24”), further to Example 24, the system further includes a second auxiliary endoprosthesis advanceable through the external access site over the second guide member into the second leg of the primary endoprosthesis and deployable in the second leg of the primary endoprosthesis to couple the second auxiliary endoprosthesis and the primary endoprosthesis. [00029] According to another example (“Example 25”), further to Example 24, the second auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

[00030] According to another example (“Example 26”), further to any one of Examples 18 to 25, the system further includes a third auxiliary endoprosthesis directable through the external access site over the guide member into the first leg of the auxiliary endoprosthesis and deploying the third auxiliary endoprosthesis in the first leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the third auxiliary endoprosthesis.

[00031] According to another example (“Example 27”), further to Example 27, the third auxiliary endoprosthesis includes a main body lumen without any branches.

[00032] According to another example (“Example 28”), further to any one of Examples 18 to 27, the system further includes a fourth auxiliary endoprosthesis directable through the external access site over the guide member into the second leg of the auxiliary endoprosthesis and deployable in the second leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the fourth auxiliary endoprosthesis.

[00033] According to another example (“Example 29”), further to Example 28, the fourth auxiliary endoprosthesis includes a main body lumen without any branches.

[00034] According to another example (“Example 30”), further to Examples 28 or 29 when including the features of Examples 26 or 27, the fourth auxiliary endoprosthesis and the third auxiliary endoprosthesis are substantially similar.

[00035] According to another example (“Example 31”), further to Examples 24 or 25, the system further includes a fifth auxiliary endoprosthesis advanceable through the external access site over the guide member into the first leg of the second auxiliary endoprosthesis and deployable in the first leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the fifth auxiliary endoprosthesis.

[00036] According to another example (“Example 32”), further to Example 31 , the fifth auxiliary endoprosthesis includes a main body lumen without any branches.

[00037] According to another example (“Example 33”), further to Examples 24 or 25, the system further including a sixth auxiliary endoprosthesis advanceable through the external access site over the guide member into the second leg of the second auxiliary endoprosthesis and deployable in the second leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the sixth auxiliary endoprosthesis. [00038] According to another example (“Example 34”), further to Example 33, the sixth auxiliary endoprosthesis includes a main body lumen.

[00039] According to another example (“Example 35”), a delivery system for delivering a device to a target vascular location through a single external access site includes a primary delivery system for advancing a primary endoprosthesis to a location proximate a bifurcation of a main vessel through an external access site in a body of a patient and for deploying the primary endoprosthesis, the primary endoprosthesis including a main body branching into a first leg and a second leg, wherein the main vessel bifurcates into a first branch and a second branch at the bifurcation. The system also includes a guide reversal system that is advanceable from the external access site through the first branch of the main vessel into the first leg of the primary endoprosthesis, as well as a guide member that is advanceable through the external access site through the first branch of the main vessel into first leg of the primary endoprosthesis, and into the main body of the primary endoprosthesis such that the guide member is directable back into the second leg of the primary endoprosthesis and into the second branch of the main vessel using the guide reversal system. The system further including an auxiliary delivery system for advancing an auxiliary endoprosthesis through the external access site over the guide member and into the second leg of the primary endoprosthesis and deploying the auxiliary endoprosthesis.

[00040] According to another Example (“Example 36”), further to Example 35, the main vessel is a descending aorta.

[00041] According to another Example (“Example 37”), further to Examples 35 or 36, the guide reversal system is configured to direct the guide member back into the second leg of the primary endoprosthesis and into the second branch of the main vessel by steering the guide member back into the second branch with a steering sheath. In some further examples, the system optionally includes a snare for snaring the guide member with the snare and drawing the guide member back into the second branch with the snare.

[00042] According to another Example (“Example 38”), further to any one of Examples 35 to 37, the auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

[00043] According to another Example (“Example 39”), further to any one of Examples 35 to 38, the auxiliary endoprosthesis is deployable in the first leg of the primary endoprosthesis with the auxiliary delivery system to couple the primary endoprosthesis and the auxiliary endoprosthesis. [00044] According to another Example (“Example 40”), further to any one of Examples 35 to 39, the system further includes a second guide member that is directable through the external access site and the first branch of the main vessel into the second leg of the primary endoprosthesis.

[00045] According to another Example (“Example 41”), further to Example 40, the system includes a second auxiliary endoprosthesis advanceable through the external access site over the second guide member into the second leg of the primary endoprosthesis and that is deployable in the second leg of the primary endoprosthesis to couple the second auxiliary endoprosthesis and the primary endoprosthesis.

[00046] According to another Example (“Example 42”), further to Example 7, the second auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

[00047] According to another Example (“Example 43”), further to any one of Examples 35 to 42, the guide member is directable back into the second leg of the primary endoprosthesis, through the first leg of the auxiliary endoprosthesis, and into the second branch of the main vessel using the guide reversal system. Additionally, the system further includes a third auxiliary endoprosthesis including a main body lumen and which is advanceable through the external access site over the guide member into the first leg of the auxiliary endoprosthesis. The system includes a third auxiliary prosthesis delivery system configured to deploy the third auxiliary prosthesis is in the first leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the third auxiliary endoprosthesis.

[00048] According to another Example (“Example 44”), further to Example 43, the third auxiliary endoprosthesis includes a main body lumen without any branches.

[00049] According to another Example (“Example 45”), further to any one of Examples 35 to 44, the guide member is directable back into the second leg of the primary endoprosthesis, through the second leg of the auxiliary endoprosthesis, and into the second branch of the main vessel using the guide reversal system, the system further including a fourth auxiliary endoprosthesis delivery system configured to advance a fourth auxiliary endoprosthesis through the external access site over the guide member into the second leg of the auxiliary endoprosthesis, the fourth auxiliary endoprosthesis being deployable in the second leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the fourth auxiliary endoprosthesis.

[00050] According to another Example (“Example 46”), further to Example 45, the fourth auxiliary endoprosthesis includes a main body lumen without any branches. [00051] According to another Example (“Example 47”), further to any one of Examples 45 or 46 when dependent upon claims 43 or 44, wherein the fourth auxiliary endoprosthesis and the third auxiliary endoprosthesis are substantially similar.

[00052] According to another Example (“Example 48”), further to any one of (i) Examples 41 or 42 or (ii) Examples 43 or 47, when dependent on Examples 41 or 42, where the guide member is directable back into the first leg of the primary endoprosthesis, through the first leg of the second auxiliary endoprosthesis, and into the first branch of the main vessel using the guide reversal system, the system further including a fifth auxiliary endoprosthesis delivery system configured to advance a fifth auxiliary endoprosthesis through the external access site over the guide member into the first leg of the second auxiliary endoprosthesis and deploy the fifth auxiliary endoprosthesis in the first leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the fifth auxiliary endoprosthesis.

[00053] According to another Example (“Example 49”), further to Example 48, the fifth auxiliary endoprosthesis includes a main body lumen without any branches.

[00054] According to another Example (“Example 50”), further to any one of (i) Examples 41 or 42 or (ii) 43 to 49 when dependent upon Examples 41 or 42, where the guide member is directable back into the first leg of the primary endoprosthesis, through the second leg of the second auxiliary endoprosthesis, and into the first branch of the main vessel using the guide reversal system and the system further includes a sixth auxiliary endoprosthesis delivery system configured to advance a sixth auxiliary endoprosthesis through the external access site over the guide member into the second leg of the second auxiliary endoprosthesis and deploy the sixth auxiliary endoprosthesis in the second leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the sixth auxiliary endoprosthesis.

[00055] According to another Example (“Example 51”), further to Example 50, wherein the sixth auxiliary endoprosthesis includes a main body lumen.

[00056] The various embodiments should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant 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 rather than restrictive in nature.

BRIEF DESCRIPTION OF THE DRAWINGS [00057] 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. The accompanying drawings are not necessarily drawn to scale but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[00058] FIGS. 1-20 illustrate various features associated with methods of, and systems for deploying endoprostheses to branched vasculature using a single (e.g., unilateral) access point.

[00059] FIG. 1 provides a high-level process diagram relating to a method of implanting a multi-level, branched endoprosthesis system using a single access point, according to some embodiments.

[00060] FIG. 2, illustrates a method that includes introducing a guide member into vasculature of a patient P from an access site S, according to some embodiments.

[00061] FIG. 3 shows a primary endoprosthesis system including a primary endoprosthesis and a primary delivery system with which the primary endoprosthesis may be associated for delivery to a desired location, according to some embodiments.

[00062] FIG. 4 shows a primary endoprosthesis including a main body branching into a first leg and a second leg, according to some embodiments.

[00063] FIG. 5 shows a first auxiliary endoprosthesis system including a first auxiliary endoprosthesis and a first auxiliary delivery system with which the first auxiliary endoprosthesis is associated for delivery to a desired implant location, according to some embodiments.

[00064] FIG. 6 shows a secondary endoprosthesis deployed so that a distal end of the secondary endoprosthesis expands into a second leg of the primary endoprosthesis, according to some embodiments.

[00065] FIG. 7 shows a second auxiliary endoprosthesis system including a second auxiliary endoprosthesis and a second auxiliary delivery system, according to some embodiments.

[00066] FIG. 8 shows the second auxiliary endoprosthesis deployed so that the distal end of the second auxiliary endoprosthesis expands into the first leg of the primary endoprosthesis, according to some embodiments.

[00067] FIG. 9 shows a guide reversal system advanced along the first guide member, within the first branch of the main vessel, into the first leg of the primary endoprosthesis, according to some embodiments. [00068] FIG. 10 shows the guide reversal system directing the first guide member into the second leg of the primary endoprosthesis, within the second branch of the main vessel, and into the first leg of the first auxiliary endoprosthesis, according to some embodiments.

[00069] FIG. 11 shows a third auxiliary endoprosthesis system moved into place over the first guide member and into the first leg of the first auxiliary endoprosthesis, according to some embodiments.

[00070] FIG. 12, shows a third auxiliary endoprosthesis deployed so that the distal end of the third auxiliary endoprosthesis expands into the first leg of the first auxiliary endoprosthesis, according to some embodiments.

[00071 ] FIG. 13 shows the first guide member fully retracted from the third auxiliary endoprosthesis and partially retracted from the first auxiliary endoprosthesis, according to some embodiments.

[00072] FIG. 14 shows the first guide member fully retracted from a fourth auxiliary endoprosthesis and from the first auxiliary endoprosthesis and directed back into the into the first leg of the primary endoprosthesis and the first leg of the second auxiliary endoprosthesis, according to some embodiments.

[00073] FIG. 15 shows the fifth auxiliary endoprosthesis advanced along the first guide member into the first leg of the second auxiliary endoprosthesis, according to some embodiments.

[00074] FIG. 16 shows the first guide member fully retracted from the fourth auxiliary endoprosthesis and from the second auxiliary endoprosthesis, according to some embodiments.

[00075] FIG. 17 shows the sixth auxiliary endoprosthesis system moved into place over the first guide member and into the second leg of the second auxiliary endoprosthesis, according to some embodiments.

[00076] FIG. 18 shows a guide reversal system including a snare operable to capture a distal portion of the first guide member, according to some embodiments.

[00077] FIG. 19 shows the snare retracted, directing the first guide member into the first leg of the primary endoprosthesis, according to some embodiments.

[00078] FIG. 20 shows a guide sheath of the guide reversal system advanced along the first guide member, within the first branch of the main vessel, into the first leg of the primary endoprosthesis and directing the first guide member along a desired path, according to some embodiments. DETAILED DESCRIPTION

[00079] This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.

[00080] With respect to terminology of inexactitude, the terms “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, minor adjustments made to optimize performance and/or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like, for example. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms “about” and “approximately” can be understood to mean plus or minus 10% of the stated value.

[00081] FIG. 1 provides a high-level process diagram relating to a method of implanting a multi-level, branched endoprosthesis system using a single access point, according to some embodiments. As shown, the method generally includes obtaining access to a patient’s vasculature with an endoluminal device guide, such as a guidewire, from a single access point (e.g., a femoral artery) in Single Access Guide Delivery Step 1002. A primary endoprosthesis, such as a branched main body endoprosthesis (e.g., a GORE® EXCLUDER® AAA Endoprosthesis), is delivered into the patient’s vasculature (e.g., within the suprarenal and/or intrarenal aorta) from the single access point in a Primary Endo Delivery Step 1012.

[00082] As described below, one or more additional guides may be introduced into the vasculature from the access point for delivery of one or more additional endoprostheses into the vasculature for coupling with the primary endoprosthesis. As part of the overall method, and according to some embodiments, at least one of the guides is reversed in direction, to pass in one direction into the main primary endoprosthesis and back, in a second direction through the primary endoprosthesis (e.g., in a distal direction, and then back in a proximal direction as defined relative to the access point), in a Guide Reversal Step 1022.

[00083] As subsequently described, various embodiments include use of a guide reversal system (e.g., including a steerable sheath, such as the bi-directional steerable guiding sheath sold by Oscor Inc. under the trade name “DESTINO”) and/or a snare (e.g., the endovascular snare system sold under the tradename “EN SNARE” by Merit Medical) to achieve reversal of the guide as part of guide reversal step 1022. One or more auxiliary endoprostheses (e.g., GORE® EXCLUDER® Iliac Branch Endoprosthesis) are delivered from the single access point using an associated delivery system introduced over the reversed guide and through the primary endoprosthesis to treat one or more branch vessels (e.g., common, interior, and/or exterior iliac).

[00084] FIGS. 2 to 20 illustrate features of a multi-level branch endoprosthesis (MLBE) system and associated method of delivery, according to various examples. As shown in the figures, the MLBE system includes a guide member 10 (FIG. 1 ), a second guide member 20 (FIG. 6), a primary endoprosthesis system 30 (FIG. 3), a first auxiliary endoprosthesis system 40a (FIG. 5) and a second auxiliary endoprosthesis system 40b (FIG. 7), a third auxiliary endoprosthesis system 50a (FIG. 11 ), a fourth auxiliary endoprosthesis system (not shown, optionally substantially similar to system 50a), a fifth auxiliary endoprosthesis system (not shown, optionally substantially similar to system 50a) and a sixth auxiliary endoprosthesis system (not shown, optionally substantially similar to system 50a), and a guide reversal system 70 (FIG. 10). As illustrated, the MLBE system can be used for a treatment site, or region of the vasculature, spanning multiple levels of branching, such as that shown extending through the aorta “A” (e.g., intrarenal), a first level of branching of the aorta at the common iliac(s) “Cl”, and a second level of branching at the internal iliac(s) “II” and external iliac(s) “El”.

[00085] The primary and second guide members 10, 20 are optionally guidewires or similar flexible members along which suitable endoprosthesis delivery systems and similar endoluminal devices may be tracked through the vasculature of a patient P (FIG. 2).

[00086] As shown in FIG. 3, the primary endoprosthesis system 30 includes a primary endoprosthesis 32 and a primary endoprosthesis delivery system 34 with which the primary endoprosthesis 32 is associated for delivery thereof to a desired location. In some embodiments, the primary endoprosthesis system is a GORE® EXCLUDER® AAA Endoprosthesis, including appropriate delivery accessories (e.g., introducer sheaths, and other components). As shown in FIG. 4, the primary endoprosthesis 32 includes a main body 320 branching into a first leg 322 and a second leg 324. As shown in FIG. 3, the primary endoprosthesis 32 may be prepared for implantation and associated with the primary endoprosthesis delivery system 34 (e.g., a delivery catheter) in a compacted state. The primary endoprosthesis 32 may be subsequently deployed from the primary endoprosthesis delivery system 34 so that the primary endoprosthesis 32 expands into a main vessel (e.g., the aorta A) that bifurcates into a first branch and a second branch (e.g., the common iliac arteries Cl).

[00087] Similarly, as shown in FIG. 5, the first auxiliary endoprosthesis system 40a includes a first auxiliary endoprosthesis 42a and a first auxiliary delivery system 44a with which the first auxiliary endoprosthesis 42a is associated for delivery thereof to a desired implant location. As shown, the first auxiliary endoprosthesis 42a has a bifurcated configuration with a main body 420 branching into a first leg 422 and a second leg 424. Similarly to the primary endoprosthesis 32, the first auxiliary endoprosthesis 42a is prepared for implantation external to the patient. For example, the first auxiliary endoprosthesis 42a may be configured in a compacted state and carried by the first auxiliary delivery system 44a (e.g., a delivery catheter). The first auxiliary endoprosthesis 42a may be subsequently deployed from the first auxiliary delivery system 44a so that the first auxiliary endoprosthesis 42a expands into a first branch vessel (e.g., the common iliac artery Cl) that further bifurcates into additional branch vessels (e.g., the internal and external iliac arteries on one side of the patient P).

[00088] As shown in FIG. 7, the second auxiliary endoprosthesis system 40b includes a second auxiliary endoprosthesis 42b and a second auxiliary delivery system 44b. The first and second auxiliary endoprostheses 42a, 42b and associated delivery systems may be substantially similar (e.g., identical, mirror images of one another, or otherwise substantially similar). In some embodiments, the first and second auxiliary endoprosthesis systems 40a, 40b are similar to the GORE® EXCLUDER® Iliac Branch Endoprosthesis systems, including endoprostheses having legs of different lengths or legs of substantially the same length (e.g., as shown in the Figures), including appropriate delivery accessories.

[00089] As shown in FIG. 11 , the third auxiliary endoprosthesis system 50a includes a third auxiliary endoprosthesis 52a and a third auxiliary delivery system 54a with which the third auxiliary endoprosthesis 52a is associated for delivery thereof to a desired implant site. The fourth, fifth and sixth auxiliary endoprosthesis systems, similarly include fourth, fifth, and sixth auxiliary endoprostheses 52b, 52c, 52d (FIG. 17), respectively, and associated delivery systems (not shown). The third through sixth auxiliary endoprosthesis systems, and in particular the delivery systems thereof, are optionally substantially similar and thus are optionally described cumulatively with the features of the third auxiliary endoprosthesis system 50a. In some embodiments, the third through sixth auxiliary endoprosthesis systems 50a, 50b, 50c, 50d are configured similarly to Internal Iliac Components of GORE® EXCLUDER® Iliac Branch Endoprosthesis Systems with legs of different lengths or the same lengths as desired. One or more of the third through sixth auxiliary endoprosthesis systems may be configured similarly to the GORE® VBX Stent Graft, GORE® VIABAHN® Device, GORE® EXCLUDER® AAA Endoprosthesis components, GORE® EXCLUDER® Iliac Branch Endoprosthesis components, and others. As shown, the third, fourth, fifth and sixth auxiliary endoprostheses 52a, 52b, 52c, 52d each optionally has a main body and is unbranched, or defines a single lumen.

[00090] FIGS. 9 to 15 illustrate features of a guide reversal system and methods of use, according to various examples. As shown in the figures, the guide reversal system helps to guide multi-level branch endoprosthesis into a target location within the body of a patient. The guide reversal system is particularly suited for navigating tortuous anatomy, such as regions of the vasculature spanning multiple levels of branching. The guide reversal system may include a steerable sheath actuatable to bend through curves using one, or a combination, of several driving mechanisms, such as tendon driven mechanisms, magnetic navigation mechanisms, or soft material driven mechanisms (e.g., shape memory effect, conducting polymer driven mechanisms, and hydraulic pressure driven mechanisms).

[00091] As shown in FIG. 2, the method includes introducing the guide member 10 into the vasculature of the patient P from an access site S. The access site S may be a unilateral access site (on a single side of the patient P), such as one of the femoral arteries that leads into a corresponding one of the external iliac arteries El.

[00092] As shown in FIG. 3 the method also includes delivering the primary endoprosthesis system 30, and in particular the primary endoprosthesis 32, over the guide member 10 (or otherwise using the guide member 10 as a guide) to a location proximate a bifurcation of a main vessel (e.g., into the aorta A proximate the bifurcation to the common iliac arteries Cl) through the external access site S in the body of the patient P.

[00093] As shown in FIG. 4, once positioned as desired, the primary endoprosthesis 32 is expanded (partially or fully) into the vasculature near the first bifurcation level (e.g., proximate the common iliac arteries Cl). The primary endoprosthesis 32 may be expanded by active expansion (e.g., using a balloon deployment system to exert an expansion force on the primary endoprosthesis 32) or self-expansion (e.g., expanding upon release from the primary endoprosthesis delivery system 34) or combinations thereof.

[00094] Also, as shown in FIG. 4, a second guide member (e.g., a second guidewire) 20 is directed through the external access site S, through the first branch of the main vessel (e.g., through the external iliac artery and the common iliac artery), and into the second leg 324 and out of the main body 320 of the primary endoprosthesis 32. And, as shown, according to some embodiments, the guide member 10 remains in place extending through the first leg 322 and main body 320 of the primary endoprosthesis 32 following partial or full deployment of the primary endoprosthesis 32 and removal of the primary endoprosthesis delivery system 34.

[00095] As shown in FIG. 5, the first auxiliary endoprosthesis system 40a is moved into place over the second guide member 20 and into the second leg 324. The secondary endoprosthesis 120 is advanced along the second guide member 20, within the first branch 102 of the main vessel, into the second leg of the primary endoprosthesis 118. As shown in FIG. 6, the secondary endoprosthesis 120 is deployed so that the distal end of the secondary endoprosthesis 120 expands into the second leg of the primary endoprosthesis 118. The second guide member 110 is then fully withdrawn. Although the second auxiliary endoprosthesis 42b is shown to be next deployed, it should be understood that, in other embodiments, the third auxiliary endoprosthesis 52a and fourth auxiliary endoprosthesis 52b are first deployed (e.g., using the methodology described in association with those components).

[00096] Referring to FIG. 7, the second auxiliary endoprosthesis system 40b is moved into place over the guide member 10 and into the first leg 322 of the primary endoprosthesis 32. The second auxiliary endoprosthesis 42b is advanced along the guide member 10, within the first branch 102 of the main vessel, into the first leg 322 of the primary endoprosthesis 32. As shown in FIG. 8, the second auxiliary endoprosthesis 42b is deployed so that the distal end of the second auxiliary endoprosthesis 42b expands into the first leg 322 of the primary endoprosthesis 32.

[00097] Referring to FIG. 9, the guide reversal system 70 (e.g., including a steerable sheath 72), is advanced along the guide member 10, within the first branch 102 of the main vessel, into the first leg 322 of the primary endoprosthesis 32. As shown in FIG. 10, the guide reversal system 70 directs the first guide member into the second leg 118 of the primary endoprosthesis 32, within the second branch 104 of the main vessel, and into the first leg 422 of the first auxiliary endoprosthesis 42a. [00098] Referring to FIG. 11 , the third auxiliary endoprosthesis system 50a is moved into place over the guide member 10 and into the first leg 422 of the first auxiliary endoprosthesis 42a. The third auxiliary endoprosthesis 52a is advanced along the guide member 10 into the first leg 422 of the first auxiliary endoprosthesis 42a. As shown in FIG. 12, the third auxiliary endoprosthesis 52a is deployed so that the distal end of the third auxiliary endoprosthesis 52a expands into the first leg 422 of the first auxiliary endoprosthesis 42a.

[00099] Referring to FIG. 13, the guide member 10 is fully retracted from the third auxiliary endoprosthesis 52a and partially retracted from the first auxiliary endoprosthesis 42a. The guide reversal system 70 directs the guide member 10 into the second leg 424 of the first auxiliary endoprosthesis 42a. The fourth auxiliary endoprosthesis system 50b is moved into place over the guide member 10 and into the second leg 424 of the first auxiliary endoprosthesis 42a. The fourth auxiliary endoprosthesis 52b is advanced along the guide member 10 into the second leg 424 of the first auxiliary endoprosthesis 42a. The fourth auxiliary endoprosthesis 52b is deployed so that the distal end of the fourth auxiliary endoprosthesis 52b expands into the second leg 424 of the first auxiliary endoprosthesis 42a.

[000100] Referring to FIG. 14, the guide member 10 is fully retracted from the fourth auxiliary endoprosthesis 52b and from the first auxiliary endoprosthesis 42a. The guide reversal system 70 directs the guide member 10 back into the into the first leg 322 of the primary endoprosthesis 32 and then into the first leg 402 of the second auxiliary endoprosthesis 42b. As shown, the guide reversal system 70 is positioned above the bifurcation in the primary endoprosthesis 32 to assist with cannulation of the first leg 322 with the guide member 10. The fifth auxiliary endoprosthesis system 50c is moved into place over the guide member 10 and into the first leg 402 of the second auxiliary endoprosthesis 42b. As shown in FIG. 15, the fifth auxiliary endoprosthesis 52c is advanced along the guide member 10 into the first leg 402 of the second auxiliary endoprosthesis 42b. The fifth auxiliary endoprosthesis 52c is deployed so that the distal end of the fifth auxiliary endoprosthesis 52c expands into the first leg 402 of the second auxiliary endoprosthesis 42b.

[000101] Referring to FIG. 16, the guide member 10 is fully retracted from the fourth auxiliary endoprosthesis 52b and from the second auxiliary endoprosthesis 42b. As shown in FIG. 17, the sixth auxiliary endoprosthesis system 50d is moved into place over the guide member 10 and into the second leg 404 of the second auxiliary endoprosthesis 42b. The sixth auxiliary endoprosthesis 52d is advanced along the guide member 10 into the second leg 404 of the second auxiliary endoprosthesis 42b. The sixth auxiliary endoprosthesis 52d is deployed so that the distal end of the sixth auxiliary endoprosthesis 52d expands into the second leg 404 of the second auxiliary endoprosthesis 42b. The sixth auxiliary delivery system (not shown) can then be retracted from the body of the patient P, along with the guide member 10.

[000102] As shown in FIG. 19, the guide reversal system 70 may include a variety of additional or alternative features to those of the steerable sheath 72 described above. As shown, a guide reversal system 70a includes a snare 210 operable to capture a distal portion of the guide member 10, as shown in FIG. 18. In particular, the snare 210 may be directed from the single access site, through the second leg 324 of the primary endoprosthesis 32. The guide member 10 and the snare 210 may be manipulated such that the guide member 10 is captured in the end of the snare 210. As shown in FIG. 19, the snare 210 is retracted, directing the guide member 10 into the first leg 322 of the primary endoprosthesis 32. The method of delivery may then proceed in a similar manner to that previously described above with regard to the steerable sheath 72.

[000103] FIG. 20 shows a guide sheath 70b, which may be flexible and trackable without the assistance of any steering mechanism (e.g., having a bias toward a curved or arcuate shape at a distal end thereof). As shown in FIG. 20, the guide sheath 70b of the guide reversal system 70a may be advanced along the guide member 10, within the first branch 102 of the main vessel, into the second leg 324 of the primary endoprosthesis 32. The guide reversal system 70a may then be used to direct the guide member 10 in similar manner to that described above in association with FIGS. 6-17 to allow the first through sixth auxiliary endoprostheses systems 40a, 40b, 50a, 50b, 50c, 50d to be advanced along the guide member 10, as previously described. For example, in addition to the position shown for the guide member 10 in FIG. 20, as shown by broken lines, the guide sheath 70b may be used to direct the guide member 10 back into the first leg 322 of the primary endoprosthesis 32 in association with the delivery steps shown in FIGS. 14 to 17. As shown, the guide sheath 70b is positioned above, or superior to, the branch or bifurcation in the primary endoprosthesis 32 to facilitate recannulation of the first leg 322 with the guide member 10 and passing of the guide member 10 back into the common iliac.

[000104] It should be understood that although certain methods and equipment are described below, other methods or equipment determined suitable by one of ordinary skill in the art may be alternatively utilized.

[000105] A biocompatible material for the graft components, discussed herein, may be used. In certain instances, the graft may include a fluoropolymer, such as a polytetrafluoroethylene (PTFE) polymer or an expanded polytetrafluoroethylene (ePTFE) polymer. In some instances, the graft may be formed of, such as, but not limited to, a polyester, a silicone, a urethane, a polyethylene terephthalate, or another biocompatible polymer, or combinations thereof. In some instances, bioresorbable or bioabsorbable materials may be used, for example a bioresorbable or bioabsorbable polymer. In some instances, the graft can include Dacron, polyolefins, carboxy methylcellulose fabrics, polyurethanes, or other woven, non-woven, or film elastomers.

[000106] The frame or stent for any of the endoprostheses described herein, and thus the endoprostheses themselves, may be configured to be self-expanding, expandable (e.g., balloon expandable), or combinations thereof. Various stent or frame materials are contemplated, including nitinol (NiTi) may be used as the material of the frame or stent (and any of the frames discussed herein), but other materials such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other appropriate biocompatible material, and combinations thereof, can be used as the material of the frame. The super-elastic properties and softness of NiTi may enhance the conformability of the stent. In addition, NiTi can be shape-set into a desired shape. That is, NiTi can be shape-set so that the frame tends to self-expand into a desired shape when the frame is unconstrained, such as when the frame is deployed out from a delivery system.

[000107] The invention of this application has been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Claims

WHAT IS CLAIMED IS:

1. A method of delivering a device to a target vascular location, the method comprising: advancing a primary endoprosthesis to a location proximate a bifurcation of a main vessel through an external access site in a body of a patient, the primary endoprosthesis including a main body branching into a first leg and a second leg, wherein the main vessel bifurcates into a first branch and a second branch at the bifurcation; deploying the primary endoprosthesis; advancing a guide reversal system from the external access site through the first branch of the main vessel into the first leg of the primary endoprosthesis; advancing a guide member through the external access site through the first branch of the main vessel into first leg of the primary endoprosthesis, and into the main body of the primary endoprosthesis; directing the guide member back into the second leg of the primary endoprosthesis and into the second branch of the main vessel using the guide reversal system; advancing an auxiliary endoprosthesis through the external access site over the guide member and into the second leg of the primary endoprosthesis; and deploying the auxiliary endoprosthesis.

2. The method of claim 1 , wherein the main vessel is a descending aorta.

3. The method of either of claims 1 or 2, wherein directing the guide member back into the second leg of the primary endoprosthesis and into the second branch of the main vessel using the guide reversal system includes (i) steering the guide member back into the second branch with a steering sheath and/or (ii) snaring the guide member with a snare and drawing the guide member back into the second branch with the snare.

4. The method of any one of claims 1 to 3, wherein the auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

5. The method of any one of claims 1 to 4, wherein the auxiliary endoprosthesis is deployed in the first leg of the primary endoprosthesis to couple the primary endoprosthesis and the auxiliary endoprosthesis.

6. The method of any one of claims 1 to 5, further comprising directing a second guide member through the external access site and the first branch of the main vessel into the second leg of the primary endoprosthesis.

7. The method of claim 6, further comprising: advancing a second auxiliary endoprosthesis through the external access site over the second guide member into the second leg of the primary endoprosthesis; and deploying the second auxiliary endoprosthesis in the second leg of the primary endoprosthesis to couple the second auxiliary endoprosthesis and the primary endoprosthesis.

8. The method of claim 7, wherein the second auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

9. The method of any of claims 1 to 8, further comprising: directing the guide member back into the second leg of the primary endoprosthesis, through the first leg of the auxiliary endoprosthesis, and into the second branch of the main vessel using the guide reversal system; advancing a third auxiliary endoprosthesis through the external access site, including a main body lumen, over the guide member into the first leg of the auxiliary endoprosthesis; and deploying the third auxiliary endoprosthesis in the first leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the third auxiliary endoprosthesis.

10. The method of claim 9, wherein the third auxiliary endoprosthesis includes a main body lumen without any branches.

11 . The method of any of claims 1 to 10, further comprising: directing the guide member back into the second leg of the primary endoprosthesis, through the second leg of the auxiliary endoprosthesis, and into the second branch of the main vessel using the guide reversal system; advancing a fourth auxiliary endoprosthesis through the external access site over the guide member into the second leg of the auxiliary endoprosthesis; and deploying the fourth auxiliary endoprosthesis in the second leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the fourth auxiliary endoprosthesis.

12. The method of claim 11 , wherein the fourth auxiliary endoprosthesis includes a main body lumen without any branches.

13. The method of claims 11 or 12 when dependent upon claims 9 or 10, wherein the fourth auxiliary endoprosthesis and the third auxiliary endoprosthesis are substantially similar.

14. The method of any of claims 7 or 8 or 9 to 13 when dependent on claims 7 or 8, further comprising: directing the guide member back into the first leg of the primary endoprosthesis, through the first leg of the second auxiliary endoprosthesis, and into the first branch of the main vessel using the guide reversal system; advancing a fifth auxiliary endoprosthesis through the external access site over the guide member into the first leg of the second auxiliary endoprosthesis; and deploying the fifth auxiliary endoprosthesis in the first leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the fifth auxiliary endoprosthesis.

15. The method of claim 14, wherein the fifth auxiliary endoprosthesis includes a main body lumen without any branches.

16. The method of claims 7 or 8 or 9 to 15 when dependent on claims 7 or 8, further comprising: directing the guide member back into the first leg of the primary endoprosthesis, through the second leg of the second auxiliary endoprosthesis, and into the first branch of the main vessel using the guide reversal system; advancing a sixth auxiliary endoprosthesis through the external access site over the guide member into the second leg of the second auxiliary endoprosthesis; and deploying the sixth auxiliary endoprosthesis in the second leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the sixth auxiliary endoprosthesis.

17. The method of claim 16, wherein the sixth auxiliary endoprosthesis includes a main body lumen.

18. A delivery system for delivering a device to a target vascular location through a single external access site, the system comprising: a primary endoprosthesis configured for implantation at a location proximate a bifurcation of a main vessel into a first branch and a second branch through an external access site in a body of a patient, the primary endoprosthesis including a main body branching into a first leg and a second leg; a guide member advanceable through the external access site through first branch of the main vessel into first leg of the primary endoprosthesis, and into the main body of the primary endoprosthesis; a guide reversal system advanceable from the external access site through the first branch of the main vessel into the first leg of the primary endoprosthesis and configured to direct the guide member back into the second leg of the primary endoprosthesis and into the second branch of the main vessel; and an auxiliary endoprosthesis advanceable through the external access site over the guide member and into the second leg of the primary endoprosthesis.

19. The system of claim 18, wherein the primary endoprosthesis is configured for implantation through the external access site into a descending aorta.

20. The system of claims 18 or 19, further comprising a steering sheath and/or a snare configured to direct the guide member back into the second leg of the primary endoprosthesis and into the second branch of the main vessel.

21 . The system of any one of claims 18 to 20, wherein the auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

22. The system of any one of claims 18 to 21 , wherein the auxiliary endoprosthesis is deployable through the external access site into the first leg of the primary endoprosthesis to couple the primary endoprosthesis and the auxiliary endoprosthesis.

23. The system of any one of claims 18 to 22, further comprising a second guide member that is directable through the external access site and the first branch of the main vessel into the second leg of the primary endoprosthesis.

24. The system of claim 23, further comprising a second auxiliary endoprosthesis advanceable through the external access site over the second guide member into the second leg of the primary endoprosthesis and deployable in the second leg of the primary endoprosthesis to couple the second auxiliary endoprosthesis and the primary endoprosthesis.

25. The system of claim 24, wherein the second auxiliary endoprosthesis includes a main body branching into a first leg and a second leg.

26. The system of any of claims 18 to 25, further comprising a third auxiliary endoprosthesis directable through the external access site over the guide member into the first leg of the auxiliary endoprosthesis and deploying the third auxiliary endoprosthesis in the first leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the third auxiliary endoprosthesis.

27. The system of claim 26, wherein the third auxiliary endoprosthesis includes a main body lumen without any branches.

28. The system of any of claims 18 to 27, further comprising a fourth auxiliary endoprosthesis directable through the external access site over the guide member into the second leg of the auxiliary endoprosthesis and deployable in the second leg of the auxiliary endoprosthesis to couple the auxiliary endoprosthesis and the fourth auxiliary endoprosthesis.

29. The system of claim 28, wherein the fourth auxiliary endoprosthesis includes a main body lumen without any branches.

30. The system of claims 28 or 29 when dependent upon claims 26 or 27, wherein the fourth auxiliary endoprosthesis and the third auxiliary endoprosthesis are substantially similar.

31 . The system of claims 24 or 25, further comprising a fifth auxiliary endoprosthesis advanceable through the external access site over the guide member into the first leg of the second auxiliary endoprosthesis and deployable in the first leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the fifth auxiliary endoprosthesis.

32. The system of claim 31 , wherein the fifth auxiliary endoprosthesis includes a main body lumen without any branches.

33. The system of claims 24 or 25, further comprising a sixth auxiliary endoprosthesis advanceable through the external access site over the guide member into the second leg of the second auxiliary endoprosthesis and deployable in the second leg of the second auxiliary endoprosthesis to couple the second auxiliary endoprosthesis and the sixth auxiliary endoprosthesis.

34. The system of claim 33, wherein the sixth auxiliary endoprosthesis includes a main body lumen.