Endoprosthesis having cannulation-assist feature

Abstract

The present disclosure relates generally to apparatuses, systems, and methods for delivering a secondary endoprosthesis into a branched endoprosthesis located in a body lumen of a patient. The apparatuses, systems and methods include snaring members with snare feature(s) deployable from a leg of a branched endoprosthesis, the snare feature(s) being operable to snare and retrieve a guidewire into the leg of the branched endoprosthesis.

Description

ENDOPROSTHESIS HAVING CANNULATION-ASSIST FEATURECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63 / 722,796, filed November 20, 2024, which is incorporated herein by reference in its entirety for all purposes.FIELD

[0002] The present disclosure relates generally to apparatuses, systems, and methods for delivering an endoprosthesis to a treatment location in a body lumen of a patient. More specifically, the disclosure relates to apparatuses, systems, and methods that include cannulation-assist feature(s) that may be used in implantable medical device.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, a bifurcated stent graft used in the treatment of abdominal aortic aneurisms is generally inserted through an iliac artery up into the abdominal aorta, where it is deployed and anchored. The graft's ipsilateral leg (a first leg) extends down into the iliac artery through which the graft was inserted. On the other hand, the graft's contralateral leg (also referring to as “contralateral gate”, i.e., a second leg shorter than the first leg) does not extend below the abdominal aorta. To extend the graft's contralateral leg down into the other iliac artery, a second stent graft is inserted through that other iliac artery over a guidewire and attached to the original graft's contralateral leg. This cannulation1DMS_US.374302867.1process is often difficult given the tortuous vasculature. Cannulation of contralateral legs of branched endoprostheses presents difficulties for medical practitioners who heretofore have had to rely heavily on trial and error.SUMMARY

[0004] There is a need for bifurcated endoprostheses, and endoprosthesis delivery systems and methods that are better adapted for ease of cannulation. This description relates to endoprostheses, and endoprosthesis delivery systems and methods for delivering endoprostheses to intravascular treatment sites including branched vessels. These endoprostheses, systems and 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, endoprostheses, delivery systems, and methods addressed in this disclosure provide one or more cannulation-assist features which allow for simplified endoluminal implantation procedures, suitable for complex target sites, such as those extending across branched vascular anatomy with one or more levels of branching.

[0005] According to one example (“Example 1”), an endoprosthesis system for delivering an implantable medical device to a target vascular location, the system 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 trunk branching into a first leg and a second leg; and a snare member extending through the first leg and the second leg of the primary endoprosthesis, and having a distal end releasably attached to the primary endoprosthesis. When the primary endoprosthesis is at least partially deployed, the snare member is deployable distally from the second leg to form a snare feature.

[0006] According to another example (“Example 2”), further to Example 1 , the endoprosthesis system further includes a delivery catheter extending through the first leg, the delivery catheter including a lumen.

[0007] According to another example (“Example 3”), further to Example 2, the snare member is advanceable inside the lumen of the delivery catheter.

[0008] According to another example (“Example 4”), further to Example 3, the lumen of the delivery catheter has an opening positioned to direct the snare member from the delivery catheter toward the second leg.2DMS_US.374302867.1

[0009] According to another example (“Example 5”), further to any one of Examples 2-4, the delivery catheter includes a delivery tube attached to the primary endoprosthesis and extending within the first leg and the second leg, the delivery tube forming a curved shape to direct the snare member from the second leg.

[0010] According to another example (“Example 6”), further to any of Examples 1-5, the endoprosthesis system further includes a snareable member configured to be removeably coupled with the snare feature of the snare member.

[0011] According to another example (“Example 7”), further to any of Examples 1-6, the endoprosthesis system further includes a first constraining member configured to releasably constrain the second leg of the primary endoprosthesis in a compacted state.

[0012] According to another example (“Example 8”), further to Example 7, the first constraining member is operable to at least partially deploy the second leg of the primary endoprosthesis from the compacted state to an expanded state such that the snare member is deployable distally from the second leg to form the snare feature.

[0013] According to another example (“Example 9”), further to Example 7 or 8, the endoprosthesis system further includes a second constraining member configured to releasably constrain the first leg of the endoprosthesis in a compacted state.

[0014] According to another example (“Example 10”), further to any one of Examples 1-9, the endoprosthesis system further includes a release line releasably coupling the distal end of the snare member to the second leg.

[0015] According to another example (“Example 11”), further to Example 10, the endoprosthesis system further includes a knot or stitch feature associated with the release line.

[0016] According to another example (“Example 12”), further to any one of Examples 1 to 11 , wherein the primary endoprosthesis is 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.

[0017] According to another example (“Example 13”), a method of delivering an implantable medical device to a target vascular location, the method 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 includes a trunk branching into a first leg and a second leg to be deployed at the location, where a snare member extends through the first leg and the second leg of the primary3DMS_US.374302867.1endoprosthesis, and has a distal end attached to the second leg. The method further includes at least partially deploying the primary endoprosthesis, extending the snare member from an end of the second leg to form a snare feature, and snaring a guidewire and retracting the guidewire into the second leg.

[0018] According to another example (“Example 14”), further to Example 13, extending the snare member further includes advancing the snare member inside a lumen of a delivery catheter, the delivery catheter extending through the first leg.

[0019] According to another example (“Example 15”), further to Example 1 , extending the snare member further includes directing the snare member out of an opening of the delivery catheter toward the second leg.

[0020] According to another example (“Example 16”), further to Examples 14 or 14, extending the snare member further includes directing the snare member through a curved tube and outward from the second leg.

[0021] According to another example (“Example 17”), further to any of Examples 13-16, at least partially deploying the primary endoprosthesis further comprises releasing a first constraining member to deploy the second leg of the primary endoprosthesis from a compacted state to an expanded state prior to extending the snare member from the second leg to form the snare feature.

[0022] According to another example (“Example 18”), further to any of Examples 13-17, the method further includes releasing the distal end of the snare member from the second leg.

[0023] According to another example (“Example 19”), further to Example 18, releasing the distal end of the snare member includes releasing a knot or stitch feature.

[0024] According to another example (“Example 20”), further to any of Examples 13-19, the method further includes delivering a secondary endoprosthesis into the second leg over the guidewire using a secondary delivery catheter.

[0025] According to another example (“Example 21”), a method of delivering an implantable medical device to a target vascular location, the method 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 trunk branching into a first leg and a second leg to be deployed at a first branch and a second branch of the main vessel at the bifurcation, where a delivery tube is attached to the primary endoprosthesis and extends within the first leg and the second leg to form a curved shape, a snaring member is received inside the delivery tube, and a distal end of4DMS_US.374302867.1the snaring member (e.g., guidewire) being attached to the second leg; at least partially deploying the primary endoprosthesis; advancing a distal portion of the snaring member out of an end of the second leg to form a snare feature; and engaging the snare feature of the snaring member with a snareable member.

[0026] The foregoing Examples are just that, and 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

[0027] 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.

[0028] FIG. 1A illustrates an example 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.

[0029] FIG. 1 B illustrate the example endoprosthesis system of FIG. 1A, according to some embodiments.

[0030] FIG. 2A illustrates an example delivery catheter, according to some embodiments.

[0031] FIG. 2B illustrates the example delivery catheter of FIG. 2A to advance a snare member, according to some embodiments.

[0032] FIGS. 3A-3E illustrate an example process of cannulating branched endoprostheses of an endoprosthesis system, according to some embodiments.

[0033] FIGS. 4A-4B illustrate an example process to form a snare feature, according to some embodiments.

[0034] FIG. 5A illustrates the example endoprosthesis including a guidewire in the lumen of the delivery tube, according to some embodiments.

[0035] FIG. 5B illustrates the example endoprosthesis of FIG. 5A including the guidewire deployable distally to form a snare feature, according to some embodiments.

[0036] FIG. 6 illustrates an example endoprosthesis delivery system including a5DMS_US.374302867.1guide tube advanceable in the lumen of a delivery catheter to form a snare feature, according to some embodiments.DETAILED DESCRIPTIONDefinitions and Terminology

[0037] 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.

[0038] 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.

[0039] Unless otherwise indicated by context, as used herein, the term “stent” includes one or more helical or circumferentially extending rings or loops of material that provides a support function to the identified device. Thus, discussion of “a stent” is meant to include a single ring, a single helix, multiple rings, multiple helices, and combinations thereof.

[0040] Unless otherwise indicated by context, as used herein, the term “graft” or “cover” includes one or more tubular sleeves or tubes of material positioned within and / or over an associated stent.Description of Various Embodiments

[0041] Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses6DMS_US.374302867.1configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

[0042] FIGS. 1A and 1 B show a primary endoprosthesis system 20, according to some embodiments. As shown, the primary endoprosthesis system 20 includes a primary endoprosthesis 22 (shown in a partially deployed, or intermediate deployment state) and a primary endoprosthesis delivery system 24, or delivery system 24. The delivery system 24 includes a delivery catheter 242 (FIG. 2A). The intermediate deployment state shown in FIGS. 1A and 1 B includes one leg of the endoprosthesis being constrained, and a second leg of the endoprosthesis being unconstrained, or at least partially expanded toward a deployed, larger diameter configuration. As shown, the delivery catheter 242 extends through the primary endoprosthesis 22. The delivery system 24 also includes a snare member 35 (FIG. 2B) that can be pre-loaded in the delivery catheter 242 before the delivery catheter 242 is introduced into the patient, or in other embodiments can be subsequently loaded in the delivery catheter 242 after introduction into the patient.

[0043] Various embodiments address the challenges commonly encountered with cannulating branched endoprostheses such as the primary endoprosthesis 22. In particular, the primary endoprosthesis 22 is generally introduced into the vasculature from a first access site (e.g., in a first leg / groin area of a patient). As will be described in greater detail, the snare member 35 can be extended out of the primary endoprosthesis 22 to define a snare feature 352, and then used to snare, or capture, another or second guide member 37 (e.g., a snareable member, or a contralateral guidewire) introduced into the patient from a second access site (second leg / groin area of a patient) to assist with cannulating the endoprosthesis with the second guide member 37. As shown in FIG. 1 B, the snare feature 352 can be retracted along a direction indicated by an arrow 21 such that the second guide member 37 is snared and directed into a second leg 224 of the primary endoprosthesis 22. In other words, the second guide member 37 acts as a contralateral guidewire, being advanced through the snare feature 352 (e.g., a snaring loop). The snare feature 352 is retracted to pull the contralateral guidewire into the second leg 224 (e.g., the contralateral leg or gate) to cannulate the second leg 224.

[0044] In some embodiments, the second guide member can then be used to direct a secondary endoprosthesis (e.g., a branch endoprosthesis) into the second leg7DMS_US.374302867.1224 of the primary endoprosthesis 22. For example, a secondary delivery catheter (not shown) can be tracked along the second guide member 37 (FIG. 1 B) into the primary endoprosthesis 22.

[0045] FIG. 2A is a first view of the delivery catheter 242 showing various, potential positions of an opening 244 through which the snare member 35 may be deployed, or extended to define the snare feature 352. As shown in FIG. 2A, the delivery catheter 242 has a first end 242a (optionally described as a proximal end), a second end 242b (optionally described as a distal end or a tip), a guide lumen 243 shown in broken lines that extends longitudinally within the delivery catheter 242. The opening 244 is in communication with the guide lumen 243 such that the snare member 35 may be extended along the guide lumen 243 and through the opening 244. As shown, the delivery catheter 242 includes the guide lumen 243 (e.g., a single internal lumen) extending longitudinally within the delivery catheter 242. Although a single lumen is shown, multiple lumens are contemplated (e.g., a first internal lumen for the snare member 35 and a second internal lumen, e.g., for receiving a primary guide member or other feature).

[0046] FIGS. 3A to 3D further illustrate example features of an endoprosthesis system and associated method of delivery, according to various embodiments. For example, FIGS. 3A to 3D illustrate additional features and functionality for cannulating the branched endoprostheses of the primary endoprosthesis system 20. The primary endoprosthesis system 20 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 108 (e.g., intrarenal), a first branch 102 and a second branch 104 of the aorta at the common iliac(s).

[0047] In some embodiments, the primary endoprosthesis 22 can be similar to the design of a GORE® EXCLUDER® AAA Endoprosthesis from W. L. Gore & Associates, Inc., including appropriate delivery accessories (e.g., introducer sheaths, and other components).

[0048] In some embodiments, the primary endoprosthesis 22 includes an endoprosthesis which can be an implantable stent graft, for example, a bifurcated stent graft. As shown in the figures, the endoprosthesis can include a main body 220, including a trunk 229 that branches into a first leg 222 and a second leg 224 of the main body 220. The first leg 222 can be relatively longer than the second leg 224. The main body 220 can be formed of a stent and a graft member coupled to the stent. In some8DMS_US.374302867.1embodiments, the graft member can form a tube-like structure that lines a blood vessel. The stent can be self-expandable to provide structural support for the graft member.

[0049] A biocompatible material for a graft member, discussed herein, may be used. In certain instances, the graft may include a fluoropolymer, such as a polytetrafluoroethylene (PTFE) polymer, an expanded polytetrafluoroethylene (ePTFE) polymer, or an expanded polyethylene (ePE) material. In some instances, the graft may be formed of, such as, but not limited to, a polyethylene, 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.

[0050] 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.

[0051] The primary endoprosthesis 22 can be prepared for implantation and associated with the primary endoprosthesis delivery system 24 (e.g., including the delivery catheter 242) in a compacted state, as shown in FIG. 3A. In some implementations, the primary endoprosthesis 22 can be constrained in the compacted state by a releasable constraint (e.g., sheath(s), sleeve(s), fiber(s)). Regardless, the primary endoprosthesis 22 is generally capable of being deployed from the primary endoprosthesis delivery system 24 so that the primary endoprosthesis 22 expands into a main vessel (e.g., the aorta 108) that bifurcates at an aortic bifurcation 106 into the first branch 102 and the second branch 104 (e.g., the common iliac arteries Cl). As shown in FIGS. 3B-3D, the delivery catheter 242 and primary endoprosthesis 22 are in9DMS_US.374302867.1a partially deployed state, with the trunk 229 at least partially deployed (e.g., either deployed to an intermediate diameter or to a fully deployed diameter) to a larger diameter, deployed configuration and the second leg 224 at least partially deployed (e.g., either deployed to an intermediate diameter or to a fully deployed diameter) to a larger diameter, deployed configuration.

[0052] In some embodiments, the primary endoprosthesis delivery system 24 can include a first constraining member operable to constrain a first portion of the primary endoprosthesis 22 (e.g., the second leg 224). The first constraining member can include a first deployment line configured to release the first constraining member such that the first portion of the primary endoprosthesis 22 can expand from a compacted state into an expanded state. The first constraining member can be a primary constraining sleeve (a knit, deconstructible sleeve) associated with a deployment line, which can releasably constrain the main body 220 and the second leg224 in a compacted state. For example, as shown in FIG. 3A, a first constraining member 224a (an edge of which is indicated by a broken line in FIG. 3A) is provided to constrain the second leg 224 in a compacted state. When the first constraining member 224a is operated, e.g., by releasing a first deployment line, the second leg 224 can be deployed from a compacted state to an expanded state (which may be a partially expanded state as opposed to a fully expanded state) as shown in FIG. 3B.

[0053] As shown, the delivery catheter 242 extends through the first leg 222 and the main body 220. The snare member 35 can be pre-loaded in the guide lumen 243 (FIG. 2A) of the delivery catheter 242 and is advanceable inside the delivery catheter 242. The delivery catheter 242 has the opening 244 to direct the snare member 35 out of the delivery catheter 242 and into the second leg 224. As shown in FIG. 3B, the snare member 35 extends through the first leg 222 and the second leg 224 of the primary endoprosthesis 22. The snare member 35 has a distal end 351 attached to a portion of the main body 220, such as to an inside of the second leg 224. In some embodiments, the distal end 351 can be attached to an inside location proximate an end 223 of the second leg 224. In some embodiments, the distal end 351 can be attached to an inside location deeper into the second leg 224, or in a more proximal position, such as adjacent to the trunk bifurcation 225. In some embodiments, the distal end 351 can be attached to an inside location of the second leg 224 between the trunk bifurcation225 and the end 223. Regardless of the specific attachment location, in various examples when the second leg 224 is deployed from a compacted state to an expanded10DMS_US.374302867.1state, a distal portion of the snare member 35 is deployable distally out of the second leg 224 to form a snare feature 352 (FIG. 30).

[0054] In some embodiments, the primary endoprosthesis 22 includes a second constraining member operable to constrain at least a portion of the primary endoprosthesis 22. The second constraining member can include a second deployment line configured to release the second constraining member such that one or more remaining, constrained portions of the primary endoprosthesis 22 (e.g., following expansion of the second leg 224) can expand from a compacted state into an expanded state. For example, in the embodiment illustrated in FIG. 3A, a second constraining member 228 (an edge of which is indicated by a broken line in FIGS. 3A-3D) can be provided to constrain at least a portion of the first leg 222 in a compacted state. The second constraining member can be a releasable sleeve, a de-constructible knit sleeve, or other feature.

[0055] In addition, the primary endoprosthesis 22 may include at attachment feature 226A including a knot, or stitch associated with a release line 226, which can temporarily attach the distal end 351 of the snare member 35 to an inside of the second leg 224 (FIG. 3B). The release line 226 may optionally be associated with the second constraining member 228 as well, such that operation of the release line 226 acts to release the first leg 222 to an expanded state and also release the distal end 351 of the snare member 35 from the main body 220. When the second constraining member 228 is operated, e.g., by releasing the release line 226, the first leg 222 can be deployed from a compacted state to an expanded state (which may be a partially expanded state as opposed to a fully expanded state), and the attachment feature 226A (e.g., a stich or knot) (FIG. 3D) can be released to release the distal end 351 of the snare member 35 from the main body 220, as shown in FIG. 3E.

[0056] In the figures, the release line 226 is shown in dotted lines and extends longitudinally along the first leg 222 and releasably attaches the distal end 351 of the snare member 35 to an inside of the second leg 224 (e.g., terminating in the attachment feature 226A such as a releasable stich or knot). As previously referenced, the snare member 35 may be releasably attached to any inside portion of the second leg 224 (e.g., adjacent to the end 223, adjacent to the trunk bifurcation 225, and the like. And, while the release line 226 is illustrated as an example of an attachment I release mechanism, the attachment I release mechanism may include a lock wire, a breakable knot or loop, or another mechanism for releasably attaching the distal end 351 of the11DMS_US.374302867.1snare member 35 to an inside of the second leg 224. Regardless, the distal end 351 of the snare member 35 may be secured to any of a variety of locations within the second leg 224, or more proximally into the trunk 229 of the main body 220.

[0057] When the primary endoprosthesis 22 is at least partially deployed, for example, when the second leg 224 is deployed from a compacted state to an expanded state, the snare member 35 is deployable (extendible) distally from the second leg 224 to form the snare feature 352. As shown in FIG. 3C, the snare member 35 is advanced inside the delivery catheter 242 through the first leg 222, out of the opening 244, and through the second leg 224 and from the second leg 224 such that a distal portion of the snare member 35 advances out of the end 223 of the second leg 224 to form the snare feature 352. As shown, the snare feature 352 is an openable and closeable loop, or enlargeable and shrinkable loop, or a loop that is diametrically adjustable between a larger and a smaller diameter. As indicated, the snare feature 352 has an end (distal end 351 of the snare member 35) attached to the main body 220 (e.g., an inside of the second leg 224) such that the movement of the distal portion 353 out of the second leg 224 can create a snaring loop as the snare feature 352, of which the size increases when the snare member 35 is further advanced inside the delivery catheter 242 and the distal portion continues to move out of, and be extended from, the second leg 224. In various examples, the snare feature 352 is able to take on an overall larger diameter than the second leg 224 to facilitate cannulating the snare member 35 with another guide member (e.g., a snareable member, a contralateral guidewire, or a second guidewire). In some examples, the snare feature 352 can be enlarged to a size that approximates the vessel in which it is located.

[0058] The snare feature 352 can be formed by various methods. In some embodiments, as shown in FIG. 30, the distal end 351 of the snare member 35 can be attached to an inside of the second leg 224 such that the distal end 351 can act as a pivot point when the distal portion of the snare member 35 is moved out of, or extended from, the second leg 224 to form the snare feature 352.

[0059] In some embodiments, as shown in FIGS. 4A and 4B, the distal end 351 of the snare member 35 can be routed to form a slip loop 54 that is attached to the main body 220. The distal portion 353 of the snare member 35 can move along the direction as indicated by an arrow 57 and advance through the slip loop 54 to form the snare feature 352. The slip loop 54, which forms part of the distal portion 353, can be releasably attached to the second leg 224.12DMS_US.374302867.1

[0060] As shown in FIGS. 3A-3D, the opening 244 of the delivery catheter 242 is optionally located longitudinally-proximate the trunk bifurcation 225 and is arranged to direct the snare member 35 from the first leg 222 into the second leg 224 - optionally through an angle of about 180 degrees (e.g., through an angle between 120 degrees and 240 degrees) at the trunk bifurcation 225. The opening 244 of the delivery catheter 242 may be located at a number of different locations along the delivery catheter 242 (e.g., defining different distances relative to the trunk bifurcation 225). FIG. 2A shows some examples of potential positions for the opening 244 at different locations with respect to the second end 242b of the delivery catheter 242. In one example, the opening 244 can be adjacent to the second end 242b, and the snare member 35 is routed in the delivery catheter 242 further to the opening 244 adjacent to the second end 242b of the delivery catheter 242. The snare member 35 exits the opening 244, reverses in direction of extension and advances into the main body 220 and across the bifurcation and into the second leg 224. In some embodiments, the opening 244 can be positioned adjacent to (e.g., substantially aligned with) an end 227 of the main body 220 of the primary endoprosthesis 22. When the primary endoprosthesis 22 is in a compacted state, the snare member 35 is optionally contained, or constrained inside the primary endoprosthesis 22 (e.g., by one or more constraining members). As previously referenced, once the second leg 224 is deployed (partially or fully), the distal end 351 of the snare member 35 remains attached to the main body 220 (e.g., the second leg 224) in such a manner that the snare member 35 is extendible, or deployable out of the second leg 224 to form the snare feature 352 (e.g., by pushing on, or extending, the snare member 35).

[0061] Referring again to FIG. 3C, when the snare feature 352 is formed outside of the second leg 224 to a desired size, a second guide member 37 can be directed through an external access site (e.g., one of the first and second external access sites), through the second branch 104 of the main vessel, and through the snare feature 352. The snare feature 352 can have a loop size that is sufficiently large for the second guide member 37 to advance through (e.g., larger than an opening into the second leg 224 and up to the size of the vessel in which the snare feature352 is located).

[0062] Referring to FIG. 3D, the second guide member 37 can then be snared by retracting or withdrawing the snare member 35 along a direction indicated by the arrow 21 to contract the snare feature 352 and pull the second guide member 37 into the second leg 224. In some embodiments, the second guide member 37 can be pulled13DMS_US.374302867.1into the second leg 224 such that the second guide member 37 extends into and at least partially through the main body 220.

[0063] In some embodiments, the distal end 351 of the snare member 35 can then be released upon deployment, for example, by releasing a temporary attachment (e.g., actuating the release line 226) upon a secondary constraining sleeve deployment.

[0064] In some embodiments, the second guide member 37 can then be retracted and pulled back through the second branch 104 to direct or pull, the snare member 35 into the second leg 224.

[0065] In some embodiments, an auxiliary endoprosthesis system can be advanced over the second guide member 37 and / or the snare member 35 and coupled to the second leg 224. For example, an auxiliary endoprosthesis (e.g., a second stent graft, not shown) of the auxiliary endoprosthesis system can be advanced along the second guide member 37 and / or the snare member 35, within the second branch 104 of the main vessel, and deployed within the second leg 224 of the primary endoprosthesis 22. The secondary endoprosthesis can be deployed so that a proximal end of the secondary endoprosthesis engages with the second leg 224 of the primary endoprosthesis 22 to extend the flow lumen of the second leg 224 into the second branch 104. This cannulation process is facilitated by the snare member 35 which is used to direct the auxiliary endoprosthesis system into place. At a desired time, the snare member 35 can then be fully withdrawn from the body of the patient.

[0066] In some embodiments, a delivery tube can be provided to attach to the primary endoprosthesis 22, and the snare member 35 can be advanceable inside the delivery tube. The delivery tube can extend within the first leg 222 and the second leg 224 to form a curved shape to direct the snare member 35 to advance outward from the second leg 224 to form the snare feature 352.

[0067] FIGS. 5A-B illustrate an example of another endoprosthesis system 500 including a delivery tube 30 such as that mentioned above to direct the snare member 35 such that it can be used to assist with cannulation of the second leg 224, according to some embodiments. As shown, the delivery tube 30 generally extends within the first leg 222, into the trunk 229 across the trunk bifurcation 225 between the first and second legs 222, 224, and into the second leg 224. The delivery tube 30 is coupled to the primary endoprosthesis, including one or more of the first leg 222, the main body 220, and the second leg 224. In some examples, the delivery tube 30 is coupled to the first leg 222 and the second leg 224 such that the delivery tube 30 takes on a bent, U-14DMS_US.374302867.1shaped, curved, or arcuate configuration or extension. As shown, the delivery tube 30 extends up the first leg 222 and down the second leg 224 such that the delivery tube 30 has a curved shape to form a curved tube. The position of the delivery tube 30 within the first and second legs 222, 224 may be adjusted to sharpen or soften the curvature, radius through which the delivery tube extends. For example, the delivery tube 30 may initially extend along an outer perimeter of the first and / or second legs 222, 224, and then transition toward the inner perimeter of the first and / or second legs 222, 224 as the delivery tube 30 extends through the trunk bifurcation 225. As shown, the delivery tube 30 is a single, monolithic component, although separate connected, or unconnected parts are also contemplated (e.g., three, separate tube segments collectively forming the delivery tube 30).

[0068] The delivery tube 30 may extend along a majority of the first and / or second legs 222, 224. As shown, the delivery tube 30 is coextensive with the first and second legs 222 and 224, with the delivery tube having ends that are coterminous with the ends of the first and second legs 222, 224. In some embodiments, the delivery tube 30 has a first tube end that is aligned, or coterminous with a first leg end 221 of the first leg 222, and a second tube end that is aligned, or coterminous with the end 223 of the second leg 224. In some embodiments, the delivery tube 30 may partially extend through the first leg 222 and / or the second leg 224 as long as the delivery tube 30 can direct the snare member 35 outward from the second leg 224, instead of up to the main body 220.

[0069] In some embodiments, the delivery tube 30 can be formed of film material. In some embodiments, at least a portion of the delivery tube 30 includes secondary reinforcement, or is formed of reinforced material. In some examples, the delivery tube 30 is reinforced in one or more portions (e.g., to maintain a particular shape and / or to facilitate operability. For example, as shown, the delivery tube 30 includes a curved portion 36 which turns about 180 degrees at the trunk bifurcation 225 from the first leg 222 into the second leg 224 (e.g., through an angle between 120 and 240 degrees). In some embodiments, the curved portion 36 is formed of one or more reinforced materials (e.g., the curved portion 36 includes a reinforcement member, such as a stent, a stiffer material, or other structural support), including any of those described above with regard to the stent and graft members of the main body 220.

[0070] As shown in FIG. 5A, the snare member 35 (e.g., a guidewire) can be pre-loaded in the internal lumen 31 of the delivery tube 30 and has the distal end 35115DMS_US.374302867.1coupled to an inside of the second leg 224. That is, the snare member 35 may be introduced into the internal lumen 31 while the primary endoprosthesis 22 is still outside a patient, and before it has been introduced into the vasculature. The snare member 35 is advanceable in the internal lumen 31 of the delivery tube 30 such that when the second leg 224 is deployed from a compacted state into an extended state, the distal portion 353 (FIG. 4A) of the snare member 35 can advance outward from the second leg 224 to form the snare feature 352.

[0071] As shown in FIG. 5B, when the snare feature 352 with a predetermined size is formed outside of the second leg 224, the second guide member 37 can be directed through the second external access site, through the second branch 104 of the main vessel (e.g., through the external iliac artery and the common iliac artery in FIG. 3A), and through the snare feature 352. The second guide member 37 can then be snared by retracting back the snare member 35, contracting the snare feature 352 and pulling the second guide member 37 into the second leg 224, in a manner similar as shown in FIGS. 1 B and 3D. The distal end 351 of the snare member 35 can then be released upon deployment, for example, by releasing a temporary attachment (e.g., releasing the release line 226 in FIG. 3D) upon deployment of a secondary constraining member. In some embodiments, the snare member 35 can be pulled to direct the second guide member 37 to extend through the second leg 224, through the second branch 104 of the main vessel, and exit the second external access site.

[0072] In a similar manner to that previously referenced, the distal portion of the snare member 35 may be releasably attached to the main body 220 (e.g., using a stitch or knot feature). In some embodiments, the delivery tube 30 can be releasably coupled to the second leg 224 along with the snare member 35 in the delivery tube 30. For example, a tube end of the delivery tube 30 can also be temporarily attached to the second leg 224. The attachment I release mechanism for the delivery tube 30 may include a lock wire, a releasable knot, or another mechanism for releasably attaching the delivery tube 30. After the second guide member 37 is pulled into place as desired using the snare member 35, the delivery tube 30 can be released from the primary endoprosthesis 22 by disengaging the temporary attachment.

[0073] In some embodiments, the delivery tube 30 can be part of the primary endoprosthesis delivery system 24 (e.g., attached to a delivery catheter). When the primary endoprosthesis delivery system 24 (e.g., a delivery catheter) is retracted from16DMS_US.374302867.1the body of the patient, the delivery tube 30 can be retracted along with the delivery catheter after the delivery tube 30 is released from the primary endoprosthesis 22.

[0074] In various embodiments including the delivery tube 30, an auxiliary endoprosthesis system can be advanced into place over the second guide member 37 and / or the snare member 35 and into the second leg 224 in a similar manner to that described above with regard to various embodiments not including the delivery tube 30. For example, a secondary endoprosthesis (e.g., a second stent graft) of the auxiliary endoprosthesis system can be advanced along the snare member 35, within the second branch 104 of the main vessel, and brough into contact with and coupled to the second leg 224 of the primary endoprosthesis 22. The secondary endoprosthesis can be deployed so that a proximal end of the secondary endoprosthesis engages with the second leg 224 of the primary endoprosthesis 22 to extend the inner flow lumen of the second leg 224 into the second branch 104. Again, here, the cannulation process is facilitated through use of the delivery tube 30 and the snare member 35.

[0075] Rather than a guide tube, or in addition to a guide tube, a guide fiber may be used to assist with tracking the snare member 35 through an arcuate path from the first leg 222 into and from the second leg 224 to form the snare feature. In such instances, it may be advantageous for the snare member 35 to be hollow, defining an inner lumen, such that the snare member 35 can track over the guide fiber. Other than substituting the guide tube for the guide fiber, the system operates similarly to embodiments described above in association with the guide tube embodiments.

[0076] FIG. 6 illustrates an example of another endoprosthesis system 600 including a guide tube 52 that is not secured to the main body 220, but instead is advanceable in a guide lumen 243 of the delivery catheter 242 for cannulation and then from the guide lumen 243 to define an arcuate path within which the snare member 35 may be tracked from the first leg 222 to the second leg 224 and from the second leg 224 to define a snare feature 352, according to some embodiments. The endoprosthesis system 600 is configured for delivering an implantable medical device to a target vascular location. The endoprosthesis system 600 includes the primary endoprosthesis 22 associated with the delivery system 24 and configured for implantation at a location proximate a bifurcation of a main vessel into a first branch and a second branch (e.g., the aorta 108 that bifurcates at the aortic bifurcation 106 into the first branch 102 and the second branch 104 in FIG. 3A) through an external access site in a body of a patient.17DMS_US.374302867.1

[0077] As shown in FIG. 6, the delivery catheter 242 is received through the first leg 222 and at least a portion of the main body 220 of the primary endoprosthesis 22 and includes a guide lumen 243 to receive a guide tube 52. The delivery catheter 242 further includes an opening 244 adjacent to the trunk bifurcation 225, facing the side of the second leg 224. The guide tube 52 is advanceable in the guide lumen 243 of the delivery catheter 242, and then from the opening 244 to define an arcuate profile (e.g., sweeping through about 180 degrees, such as between 120 and 240 degrees) as shown.

[0078] The snare member 35 can be pre-loaded in the guide tube 52, or subsequently loaded in the guide tube 52, and is advanceable within the guide tube 52. That is, the snare member 35 may be introduced into the guide lumen 243 while the primary endoprosthesis 22 is still outside a patient, and before it has been introduced into the vasculature, or after such introduction in other embodiments. The snare member 35 has a distal end 351 formed in a snare configuration such that the snare member 35 is deployable distally from the second leg 224 to form a snare feature 352. The snare feature 352 may be pre-formed at the distal end 351 or the distal end 351 may be configured to be actuable to form a snare.

[0079] The guide tube 52 includes a distal portion 522 that is extendable from the opening 244 of the delivery catheter 242 to an extended position. The guide tube 52 extends up in the guide lumen 243 of the delivery catheter 242 through the first leg 222 to exit the opening 244, and curves down toward the second leg 224 such that the distal portion 522 forms a curved shape in the extended position. In some embodiments, a distal end 521 of the distal portion 522 can extend into the second leg 224. In some embodiments, the distal end 521 of the distal portion 522 can point toward the second leg 224, without extending into the second leg 224.The opening 244 can be located adjacent to the trunk bifurcation 225, adjacent to the second end 242b of the delivery catheter 242 (e.g., adjacent to the end 227 of the main body 220), or any location therebetween.

[0080] As shown, the distal portion 522 of the guide tube 52 takes on the curved shape configured to direct the snare member 35 such that it may be advanced through the second leg 224, resulting in the distal portion of the guidewire 55 extending out of the second leg 224 to form the snare feature 352.

[0081] In some embodiments, at least the distal portion 522 of the guide tube 52 is formed of nitinol or another shape memory material such that it takes on the curved,18DMS_US.374302867.1or arcuate shape as it is extended from the opening 244. The distal portion 522 of the guide tube 52 can be formed of any suitable material configured to be self-forming and / or bendable to form a curved shape. The distal portion 522 can be shape-set so that the distal portion 522 tends to self-bend into a curved shape when the distal portion 522 is unconstrained, such as when the distal portion 522 extends out from the opening 244 of the delivery catheter 242. Prior to extension, the distal portion 522 may be maintained in a less curved shaped. For example, the body of the delivery catheter 242 may have sufficiently resilience to resist deformation due to the shape-set, self-bending property of the distal portion 522 until it is extended and unconstrained by the delivery catheter 242.

[0082] In various examples, when the primary endoprosthesis 22 is in a compacted state, the distal portion 522 of the guide tube 52 is received inside the guide lumen 243 of the delivery catheter 242. When the primary endoprosthesis 22 is deployed from the compacted state to an at least partially expanded state, the distal portion 522 of the guide tube 52 can be extended out of the opening 244 of the delivery catheter 242, curving down, or proximally toward the second leg 224 to facilitate the deployment of a distal portion of the snare member 35 distally from the second leg 224 to form the snare feature 352. In some embodiments, the distal portion 522 of the guide tube 52 has a steering mechanism (e.g., one or more pull wires) such that the distal portion can be actuated by tensioning the steering mechanism, either in addition to, or as an alternative to the self-curving feature described above.

[0083] When the snare feature 352 of a desired size is formed outside of the second leg 224, a second guide member (e.g., the second guide member 37 in FIG. 1 B, 3, 4 or 5B) can be directed through a second external access site, through a branch of a main vessel (e.g., the second branch 104 through the external iliac artery and the common iliac artery in FIG. 3C), and through the snare feature 352. The second guide member 37 can be then snared by retracting back the snare member 35, retrieving the snare feature 352 and pulling the second guide member 37 into the second leg 224. In some embodiments, the distal end 351 of the snare member 35 can be then retracted into the guide tube 52 and the guide tube 52 can be retracted back (e.g., into the delivery catheter 242 through the opening 244). In some embodiments, the snare member 35 can be pulled to direct the second guide member 37 to extend into the second leg 224.19DMS_US.374302867.1

[0084] In some embodiments, when the snare member 35 is used to pull the second guide member 37 into place using the snare feature 352, the distal portion 522 of the guide tube 52 can be retracted into the guide lumen 243 of the delivery catheter 242. The delivery catheter 242 can be then retracted from the body of the patient, along with the guide tube 52 and the snare member 35.

[0085] In some embodiments, an auxiliary endoprosthesis system can be advanced into place over the secondary guidewire (not shown) and into the second leg 224. For example, a secondary endoprosthesis (e.g., a second stent graft) of the auxiliary endoprosthesis system can be advanced along the second guide member 37, within the second branch 104 of the main vessel, and contact with the second leg 224 of the primary endoprosthesis 22. The secondary endoprosthesis can be deployed so that a proximal end of the secondary endoprosthesis engages and couples with the second leg 224 of the primary endoprosthesis 22 to extend the inner flow lumen of the second leg 224 into the second branch 104. The second guide member 37 can be then fully withdrawn from the body of the patient.

[0086] The disclosure 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 disclosure provided they come within the scope of the appended claims and their equivalents.20DMS_US.374302867.1

Claims

WHAT IS CLAIMED IS:

1. An endoprosthesis system for delivering an implantable medical device to a target vascular location, the endoprosthesis system comprising: a primary endoprosthesis including a trunk branching into a first leg and a second leg; and a snare member extending through the first leg and the second leg of the primary endoprosthesis, and having a distal end releasably attached to the primary endoprosthesis, the snare member being deployable distally from the second leg to form a snare feature.

2. The endoprosthesis system of claim 1 , further comprising a delivery catheter extending through the first leg, the delivery catheter including a lumen.

3. The endoprosthesis system of claim 2, wherein the snare member is advanceable inside the lumen of the delivery catheter.

4. The endoprosthesis system of claim 3, wherein the delivery catheter has an opening positioned to direct the snare member from the delivery catheter toward the second leg.

5. The endoprosthesis system of any one of claims 2-4, wherein the delivery catheter includes a delivery tube attached to the primary endoprosthesis and extending within the first leg and the second leg, the delivery tube forming a curved shape to direct the snare member from the second leg.

6. The endoprosthesis system of any one of claims 1-5, further comprising a snareable member configured to be removeably coupled with the snare feature of the snare member.

7. The endoprosthesis system of any one of claims 1-6, further comprising a first constraining member configured to releasably constrain the second leg of the primary endoprosthesis in a compacted state.21DMS_US.374302867.

18. The endoprosthesis system of claim 7, wherein the first constraining member is operable to at least partially deploy the second leg of the primary endoprosthesis from the compacted state to an expanded state such that the snare member is deployable distally from the second leg to form the snare feature.

9. The endoprosthesis system of claims 7 or 8, further comprising a second constraining member configured to releasably constrain the first leg of the primary endoprosthesis in a compacted state.

10. The endoprosthesis system of any one of claims 1 to 9, further comprising a release line releasably coupling the distal end of the snare member to the second leg.

11. The endoprosthesis system of claim 10, further comprising a knot or stitch feature associated with the release line.

12. The endoprosthesis system of any one of claims 1 to 11 , wherein the primary endoprosthesis is 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.

13. A method of delivering an implantable medical device to a target vascular location, the method comprising: advancing a primary endoprosthesis having a snare member releasably coupled to the 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 trunk branching into a first leg and a second leg to be deployed at the location, wherein the snare member extends through the first leg and the second leg of the primary endoprosthesis, and has a distal end attached to the second leg; extending the snare member from an end of the second leg to form a snare feature; and snaring a guidewire and retracting the guidewire into the second leg.22DMS_US.374302867.

114. The method of claim 13, wherein extending the snare member further comprises at least partially deploying the second leg toward an expanded, deployed configuration and advancing the snare member inside a lumen of a delivery catheter, the delivery catheter extending through the first leg.

15. The method of claim 14, wherein extending the snare member further comprises directing the snare member out of an opening of the delivery catheter toward the second leg.

16. The method of claim 14, wherein extending the snare member further comprises directing the snare member through a curved tube to and outward from the second leg.

17. The method of any one of claims 13-16, wherein at least partially deploying the primary endoprosthesis further comprises releasing a first constraining member to deploy the second leg of the primary endoprosthesis from a compacted state to an expanded state prior to extending the snare member from the second leg to form the snare feature.

18. The method of any one of claims 13-17, further comprising releasing the distal end of the snare member from the second leg.

19. The method of claim 18, wherein releasing the distal end of the snare member includes releasing a knot or stitch feature.

20. The method of any one of claims 13-19, further comprising delivering a secondary endoprosthesis into the second leg over the guidewire using a secondary delivery catheter.

21. A method of delivering an implantable medical 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 trunk branching into a first leg and a23DMS_US.374302867.1second leg to be deployed at a first branch and a second branch of the main vessel at the bifurcation, wherein a delivery tube is attached to the primary endoprosthesis and extends within the first leg and the second leg to form a curved shape, a snaring member is received inside the delivery tube, and a distal end of the snaring member being coupled to the second leg; at least partially deploying the primary endoprosthesis; advancing a distal portion of the snaring member out of an end of the second leg to form a snare feature; and engaging the snare feature of the snaring member with a snareable member.24DMS_US.374302867.1

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