Endoprosthesis having cannulation-assist feature

Abstract

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 features for placing endoprostheses.

Description

ENDOPROSTHESIS HAVING CANNULATION-ASSIST FEATURECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63 / 722,837, 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 over1DMSJJS.374303018.1a guidewire and attached to the original graft's contralateral leg. This cannulation process 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 is provided for treating a target vascular location. The endoprosthesis includes a main body including a stent and a graft member coupled to the stent, the main body configured for implantation through an external access site in a body of a patient, the main body including a trunk that branches into a first leg and a second leg; a delivery tube coupled to the main body and extending within the main body, the delivery tube extending within the first and second legs such that the delivery tube extends up the first leg and down the second leg and the delivery tube has a curved shape, the delivery tube including an internal lumen; and a guide member advanceable in the internal lumen of the delivery tube into the first leg and out of the second leg.

[0006] According to another example (“Example 2”), further to Example 1 , the delivery tube is formed of film material.

[0007] According to another example (“Example 3”), further to Examples 1 or 2, the delivery tube extends within a majority of a length of the first leg and a majority of a length of the second leg, and optionally wherein the delivery tube is coextensive with the first and second legs.2DMSJJS.374303018.1

[0008] According to another example (“Example 4”), further to any of Examples 1 to 3, the delivery tube has a first tube end, the first leg has a first leg end, and the first tube end is coterminous with the first leg end.

[0009] According to another example (“Example 5”), further to any of Examples 1 to 4, the delivery tube has a second tube end, the second leg has a second leg end, and the second tube end is coterminous with the second leg end.

[0010] According to another example (“Example 6”), further to any of Examples 1 to 5, at least a portion of the delivery tube is formed of reinforced material.

[0011] According to another example (“Example 7”), further to any of Examples 1 to 6, when the main body is in a compacted state having a lower outer profile than an expanded state of the main body, the delivery tube is in a compacted configuration; and when the main body is deployed from the compacted state to the expanded state, the delivery tube is in an expanded configuration having a greater outer profile than the compacted configuration of the delivery tube.

[0012] According to another example (“Example 8”), further to any of Examples 1 to 7, the delivery tube is releasably attached to the main body within the first and second legs.

[0013] According to another example (“Example 9”), a delivery system is provided for delivering an implantable medical device to a target vascular location. The system includes a primary endoprosthesis configured for implantation through an external access site in a body of a patient, the primary endoprosthesis including a trunk that branches into a first leg and a second leg; a delivery catheter extending through the first leg of the primary endoprosthesis and including a lumen; a hollow guide member advanceable in the lumen of the delivery catheter; and a secondary guidewire receivable within the hollow guide member. The hollow guide member comprises a distal portion configured to extend out of the delivery catheter to transition from a longitudinally-elongated state to a curved state.

[0014] According to another example (“Example 10”), further to Example 9, the distal portion of the hollow guide member has the curved shape configured to direct the secondary guidewire to advance through the second leg, and the secondary guidewire has a distal end extending out of the second leg.3DMSJJS.374303018.1

[0015] According to another example (“Example 11”), further to Example 9 or 10, further comprising a snaring guidewire to engage with the distal end of the secondary guidewire.

[0016] According to another example (“Example 12”), further to any of Examples 9-11 , the distal portion of the hollow guide member is formed of nitinol.

[0017] According to another example (“Example 13”), further to any of Examples 9-12, the delivery catheter includes a tip, and the hollow guide member is configured to extend up in the lumen of the delivery catheter to exit the tip, and the distal portion curves down toward the second leg upon exiting the tip.

[0018] According to another example (“Example 14”), further to any of Examples 9-13, when the primary endoprosthesis is in a compacted state, the distal portion of the hollow guide member is received inside the hollow guide member; and when the primary endoprosthesis is deployed from the compacted state to an expanded state, the distal portion of the hollow guide member extends out of the delivery catheter to form the curved shape.

[0019] According to another example (“Example 15”), a delivery system is provided for delivering an implantable medical device to a target vascular location. The system includes a primary endoprosthesis configured for implantation 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; a delivery catheter extendable through the first leg of the primary endoprosthesis and including a lumen and a side opening; a guide tube advanceable in the lumen of the delivery catheter; and a secondary guidewire receivable within the guide tube. The guide tube comprises a distal portion that is extendable from the side opening of the delivery catheter from a retracted position to an extended position, and the distal end portion transitions to a curved shape in the extended position.

[0020] According to another example (“Example 16”), further to Example 15, the distal portion of the guide tube has the curved shape configured to direct the secondary guidewire to advance through the second leg, and the secondary guidewire has a distal end extending out of the second leg.

[0021] According to another example (“Example 17”), further to Example 16, further comprising a snaring guidewire to engage with the distal end of the secondary guidewire.4DMSJJS.374303018.1

[0022] According to another example (“Example 18”), further to any of Examples 15-17, the distal portion of the guide tube is formed of nitinol.

[0023] According to another example (“Example 19”), further to any of Examples 15-18, the guide tube extends up in the lumen of the delivery catheter to exit the side opening and curves down toward the second leg.

[0024] According to another example (“Example 20”), further to any of Examples 15-19, when the primary endoprosthesis is in a compacted state, the distal portion of the guide tube is received inside the lumen of the delivery catheter; and when the primary endoprosthesis is deployed from the compacted state to an expanded state, the distal portion of the guide tube extends out of the delivery catheter to form the curved shape.

[0025] According to another example (“Example 21”), a delivery system is provided for delivering an implantable medical device to a target vascular location. The system includes a primary endoprosthesis configured for implantation 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; a cannulation fiber extending through the first leg, around the bifurcation, and through the second leg; an exchange catheter advanceable over the cannulation fiber through the first leg; and a secondary guidewire receivable within the exchange catheter. The exchange catheter includes a distal portion that is extendable over the cannulation fiber to form a curved shape toward the second leg.

[0026] According to another example (“Example 22”), a method of treating a target vascular location is provided. The method includes delivering an endoprosthesis through an external access site in a body of a patient at a location proximate a bifurcation of a main vessel into a first branch and a second branch. The endoprosthesis includes a main body including a stent and a graft member coupled to the stent, the main body further including a trunk that branches into a first leg and a second leg; a delivery tube extending coupled to the main body and extending within the main body, the delivery tube extending within the first and second legs such that the delivery tube extends up the first leg and down the second leg and the delivery tube has a curved shape, the delivery tube including an internal lumen; and a guide member advanceable in the internal lumen of the delivery tube into the first leg and out of the second leg.5DMSJJS.374303018.1

[0027] 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

[0028] 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.

[0029] FIG. 1 illustrates an example method that includes introducing a guide member into vasculature of a patient from an access site, according to some embodiments.

[0030] FIG. 2 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.

[0031] FIG. 3A illustrates an example endoprosthesis including a delivery tube, according to some embodiments.

[0032] FIG. 3B illustrates the example endoprosthesis of FIG. 3A including a guidewire in the lumen of the delivery tube, according to some embodiments.

[0033] FIG. 3C illustrates the example endoprosthesis of FIG. 3B including the guidewire engaged with a snaring guidewire, according to some embodiments.

[0034] FIG. 4A illustrates an example endoprosthesis delivery system including a hollow guide member, according to some embodiments.

[0035] FIG. 4B illustrates the example endoprosthesis delivery system of FIG. 4A including a guidewire in the lumen of the hollow guide member, according to some embodiments.

[0036] FIG. 5 illustrates an example endoprosthesis delivery system including a guide tube advanceable in the lumen of a delivery catheter, according to some embodiments.

[0037] FIG. 6A illustrates an example endoprosthesis delivery system including a6DMSJJS.374303018.1cannulation fiber, according to some embodiments.

[0038] FIG. 6B illustrates the example endoprosthesis delivery system of FIG. 6A including an exchange catheter advanceable over the cannulation fiber, according to some embodiments.

[0039] FIG. 6C illustrates the example endoprosthesis delivery system of FIG. 6B including a guidewire advanceable through the exchange catheter, according to some embodiments.

[0040] FIG. 6D illustrates the example endoprosthesis delivery system of FIG. 6C with the exchange catheter being removed, according to some embodiments.

[0041] FIG. 7A illustrates an example exchange catheter, according to some embodiments.

[0042] FIG. 7B illustrates a cross-sectional view of the example exchange catheter of FIG. 7A, according to some embodiments.DETAILED DESCRIPTIONDefinitions and Terminology

[0043] 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.

[0044] 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” and7DMSJJS.374303018.1“approximately” can be understood to mean plus or minus 10% of the stated value.

[0045] 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.

[0046] 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.

[0047] Unless otherwise indicated by context, as used herein, the term “bifurcated stent graft” refers to a branched endoprosthesis including a trunk that branches into a first leg and a second leg. The legs may be similar lengths, or one may be shorter than the other. In this context, a shorter leg may be referred to as a “gate” that is suitable for receiving an auxiliary “leg” to extend the length of the shorter leg. In various examples, a “first leg” may be referred to as an ipsilateral leg and the “second leg” may refer as a contralateral leg or a contralateral gate. The terms “leg” and “limb” may be used interchangeably.Description of Various Embodiments

[0048] Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured 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.

[0049] FIGS. 1 to 5 illustrate example features of an endoprosthesis system and associated method of delivery, according to various embodiments. FIG. 1 illustrates an example method that includes introducing a primary guide member 10 into vasculature of a patient 2 from a first external access site 201 or a second external access site 202. The primary guide member 10 can be a guidewire or a similar flexible member along which suitable endoprosthesis delivery systems and similar endoluminal devices may be tracked through the vasculature of a patient 2.

[0050] FIG. 2 illustrates an example primary endoprosthesis system 20 including8DMSJJS.374303018.1a primary endoprosthesis 22 and a primary endoprosthesis delivery system 24 with which the primary endoprosthesis may be associated for delivery to a desired location, according to some embodiments. As illustrated, 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 “A” 108 (e.g., intrarenal), a first level of branching of the aorta at the common iliac(s) “Cl” 102, 104, and a second level of branching, where each common iliac(s) “Cl” 102, 104 divides into the internal iliac(s) “II” 103 and external iliac(s) “El” 105.

[0051] In some embodiments, the primary endoprosthesis system 20 can be a GORE® EXCLUDER® AAA Endoprosthesis from W. L. Gore & Associates, Inc., including appropriate delivery accessories (e.g., introducer sheaths, and other components).

[0052] In some embodiments, the primary endoprosthesis system 20 can include an endoprosthesis which can be an implantable stent graft, for example, a bifurcated stent graft. The endoprosthesis can include a main body. The main body can be formed of a stent and a graft member coupled to the stent. In some embodiments, 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. The main body can include a trunk that branches into a first leg and a second leg.

[0053] 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 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.

[0054] 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 the9DMSJJS.374303018.1frame 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. For example, in the embodiment illustrated in FIG. 2, the primary endoprosthesis 22 is in a compacted state having a lower outer profile than an expanded state of the main body. In the embodiments illustrated in FIGS. 3A-5, the primary endoprosthesis 22 is deployed from the compacted state to the expanded state, with a main body 220 branching into a first leg 222 and a second leg 224.

[0055] The primary endoprosthesis 22 can be prepared for implantation and associated with the primary endoprosthesis delivery system 24 (e.g., a delivery catheter) in a compacted state. In some implementations, the primary endoprosthesis 22 is constrained in the compacted state by a releasably constraint (e.g., sheath(s), sleeve(s), fiber(s)). Regardless, the primary endoprosthesis 22 is generally capable of being subsequently 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 a first branch 102 and a second branch 104 (e.g., the common iliac arteries Cl).

[0056] FIG. 3A illustrates an example endoprosthesis system 300 including a delivery tube 30 for cannulation, according to some embodiments. FIG. 3B illustrates the example endoprosthesis of FIG. 3A including a guidewire in the lumen of the delivery tube, according to some embodiments. FIG. 3C illustrates the example endoprosthesis of FIG. 3B including the guidewire engaged with a snaring guidewire, according to some embodiments.

[0057] In some embodiments, the primary endoprosthesis 22 is deployed from the primary endoprosthesis delivery system 24 (e.g., a delivery catheter) so that the primary endoprosthesis 22 expands from the compacted state (FIG. 2) into an expanded state (FIGS. 3A-3C).

[0058] As shown in FIG. 3A, the primary endoprosthesis 22 includes the main10DMSJJS.374303018.1body 220 branching into the first leg 222 and the second leg 224. As shown, the main body 220 includes a trunk 229 that branches at a trunk bifurcation 225 into the first leg 222 and the second leg 224. The primary endoprosthesis 22 is configured for treating a target vascular location. The main body 220 includes a stent 22a and a graft member 22b coupled to the stent 22a. The main body 220 is configured for implantation through an external access site (e.g., one of the first and second external access sites 201 and 202 in FIG. 1) in a body of a patient at a location proximate a bifurcation of a main vessel into a first branch and a second branch such as, for example, the common iliac arteries (Cl) of the first and second branches 102 and 104 in FIGS. 1 and 2.

[0059] 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-shaped, 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. 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).

[0060] 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 30a that is aligned, or coterminous with a first leg end 221 of the first leg 222, and a second tube end 30b that is aligned, or coterminous with a second leg end 223 of the second leg 224. In some embodiments, the delivery tube 30 may partially extend through the first leg 222 and the second leg 224.11DMSJJS.374303018.1

[0061] 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° at the trunk bifurcation 225 from the first leg 222 into the second leg 224. 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 material having a greater stiffness, or other structural support). In some embodiments, the delivery tube 30 can be formed of a dense ePTFE film tube with a NiTi wire as a reinforcement member in the curved portion 36.

[0062] The delivery tube 30 (e.g., the entirety or a portion of the delivery tube) may be adapted to collapse or otherwise take on a more compacted configuration. In some embodiments, when the main body 220 of the primary endoprosthesis 22 is in a compacted state (e.g., see the primary endoprosthesis 22 of FIG. 2 which is compacted), the delivery tube 30 may also take on a compacted configuration. For example, the curved portion 36 may take on a more folded state or collapsed state. When the main body 220 is deployed from the compacted state to the expanded state (FIGS. 3A-C), the delivery tube 30, in turn, may transition to an expanded configuration having a greater outer profile than the compacted configuration of the delivery tube 30, with the curved portion 36 being unfolded (e.g., transitioning from a flattened profile to a more arcuate, or curved profile. In some examples, the delivery tube 30 can have an inner diameter in a range, for example, from 0.015” to 0.038” (0.38 mm to 0.97 mm) when the delivery tube 30 is in the expanded configuration.

[0063] As shown in FIG. 3B, a guide member 35 (e.g., a guidewire) is advanceable in the internal lumen 31 of the delivery tube 30 as it is passed into the first leg 222 and out of the second leg 224. In some embodiments, the guide member 35 can be pre-loaded into the internal lumen 31 of the delivery tube 30. That is, the guide 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 primary endoprosthesis 22 in the compacted state can be subsequently placed onto the primary guide member 10 and advanced along the12DMSJJS.374303018.1primary guide member 10 within one of common iliac arteries (Cl) to a position adjacent to the aortic bifurcation 106 (FIG. 2). The primary endoprosthesis 22 can then be deployed from the primary endoprosthesis delivery system 24 so that the primary endoprosthesis 22 expands into the expanded state. The guide member 35 can be directed inside the delivery tube 30 to advance through the second leg 224 such that a distal end 351 of the guide member 35 extends out of the second leg end 223 of the second leg 224 (FIG. 3B).

[0064] As shown in FIG. 3C, a second guide member 37 (e.g., a snaring guidewire) can be directed through an external access site (e.g., one of the first and second external access sites 201 and 202 of FIG. 1), through the second branch 104 of the main vessel (e.g., through the external iliac artery and the common iliac artery in FIG. 1), and engage with the distal end 351 of the guide member 35. The second guide member 37 can be pulled to direct the guide member 35 to extend through the second leg 224, through the second branch 104 of the main vessel, and exit the external access site (e.g., one of the first and second external access sites 201 and 202 of FIG. 1).

[0065] In some embodiments, the delivery tube 30 can be releasably coupled to the first leg 222 and the second leg 224. For example, the second tube end 30b can be temporarily attached to the second leg end 223 of the second leg 224. When the guide member 35 is pulled into place by the second guide member 37, the delivery tube 30 can be released from the primary endoprosthesis 22 by disengaging the temporary attachment. The attachment I release mechanism may include a lock wire, a releasable knot, or another mechanism for releasably attaching the delivery tube 30. In some embodiments, a deployment line 34 from a secondary sleeve can be utilized as the attachment I release mechanism. The deployment line 34 can extend along the main body 220 to the first leg 222 and through the second leg end 223 of the second leg 224 to releasably attach the second tube end 30b of the delivery tube 30 to the second leg 224.

[0066] 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 from the body of the patient P, the delivery tube 30 can be retracted along with the delivery catheter after the delivery tube 30 is released from the primary endoprosthesis 22.13DMSJJS.374303018.1

[0067] In some embodiments, an auxiliary endoprosthesis system can be advanced into place over the guide member 35 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 guide member 35, 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 distal end of the secondary endoprosthesis expands into the second leg 224 of the primary endoprosthesis 22 to extend the second leg 224 into the second branch 104. This cannulation process is now relatively easy given the guide member 35 to direct the auxiliary endoprosthesis system into place. The guide member 35 can be then fully withdrawn.

[0068] FIGS. 4A-4B illustrate an example of another endoprosthesis delivery system 400 including a hollow guide member 42 for cannulation, according to some embodiments. The endoprosthesis delivery system 400 is configured for delivering an implantable medical device to a target vascular location. The endoprosthesis delivery system 400 includes a primary endoprosthesis 22 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 22 includes a trunk or main body 220 that branches into a first leg 222 and a second leg 224. A delivery catheter 40 extends through the first leg 222 of the primary endoprosthesis 22. The delivery catheter 40 includes a lumen 41 to receive a hollow guide member 42. The hollow guide member 42 is advanceable in the lumen 41 of the delivery catheter 40. A secondary guidewire 45 is receivable within the hollow guide member 42. In one example, the hollow guide member 42 has an inner diameter of about 0.035” (0.89 mm) and the secondary guidewire 45 has a diameter of about 0.018” (0.46 mm).

[0069] The hollow guide member 42 includes a distal portion 422 configured to extend out of the delivery catheter 40 to form a curved shape. As shown in FIG. 4B, the distal portion 422 of the hollow guide member 42 has the curved shape configured to have its tip 421 pointing toward the second leg 224 and direct the secondary guidewire 45 to exit the tip 421 to advance into and through the second leg 224 such that the secondary guidewire 45 has a distal end 451 extending out of the second leg 224.14DMSJJS.374303018.1

[0070] In some embodiments, the distal portion 422 of the hollow guide member 42 is formed of a strand stainless steel hollow coil that is shape-set. It is to be understood that the distal portion 422 of the hollow guide member 42 can be formed of any suitable material configured to be self-bending / bendable to form a curved shape. The distal portion 422 can be shape-set so that the distal portion 422 tends to self-bend into a curved shape or to transition from a longitudinally-elongated state to a curved state when the distal portion 422 is unconstrained, such as when the distal portion 422 extends out from the lumen 41 of the delivery catheter 40.

[0071] The delivery catheter 40 includes a tip 402, and the hollow guide member 42 extends up in the lumen 41 of the delivery catheter 40 through the first leg 222 to exit the tip 402 and curves down toward the second leg 224.

[0072] When the primary endoprosthesis 22 is in a compacted state, the distal portion 422 of the hollow guide member 42 is received inside the delivery catheter 40. When the primary endoprosthesis 22 is deployed from the compacted state to an expanded state, the distal portion 422 of the hollow guide member 42 can extend out of the tip 402 of the delivery catheter 40 and curve down toward the second leg 224.

[0073] In some embodiments, a second guide member (e.g., the second guide member 37 (e.g., a snaring guidewire) of FIG. 3C) can be provided to engage with the distal end 451 of the secondary guidewire 45. The snaring guidewire can be directed through an external access site (e.g., the external access site 202 of FIG. 1), through the second branch 104 of the main vessel (e.g., through the external iliac artery and the common iliac artery), and engage with the distal end 451 of the secondary guidewire 45. The snaring guidewire can be pulled to direct the secondary guidewire 45 to extend through the second leg 224, through the second branch 104 of the main vessel, and exit the external access site 202.

[0074] When the secondary guidewire 45 is pulled into place by the snaring guidewire, the distal portion 422 of the hollow guide member 42 can be retracted into the lumen 41 of the delivery catheter 40. The delivery catheter 40 can be then retracted from the body of the patient, along with the hollow guide member 42.

[0075] In some embodiments, an auxiliary endoprosthesis system can be moved into place over the secondary guidewire 45 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 secondary guidewire 45, within the15DMSJJS.374303018.1second 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 distal end of the secondary endoprosthesis expands into the second leg 224 of the primary endoprosthesis 22 to extend the second leg 224 into the second branch 104 of the main vessel. This cannulation process is now relatively easy given the secondary guidewire 45 to direct the auxiliary endoprosthesis system into place. The secondary guidewire 45 can be then fully withdrawn.

[0076] FIG. 5 illustrates an example of another endoprosthesis delivery system 500 including a guide tube 52 advanceable in a lumen 51 of a delivery catheter 50 for cannulation, according to some embodiments. The endoprosthesis delivery system 500 is configured for delivering an implantable medical device to a target vascular location. The endoprosthesis delivery system 500 includes a primary endoprosthesis 22 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 FIGS. 1 and 2) through an external access site (e.g., one of the first and second external access sites 201 and 202 in FIG. 1) in a body of a patient. The primary endoprosthesis 22 including a trunk branching into a first leg 222 and a second leg 224.

[0077] A delivery catheter 50 is extendable through the first leg 222 of the primary endoprosthesis 22 and includes a lumen 51 to receive a guide tube 52. The delivery catheter 50 further includes a side opening 53 adjacent to the trunk bifurcation 225, facing the side of the second leg 224. The guide tube 52 is advanceable in the lumen 51 of the delivery catheter 50. A secondary guidewire 55 is receivable within the guide tube 52. In one example, the secondary guidewire 55 can have a diameter of 0.035” (0.89 mm) or less (e.g., 0.18” or 0.46 mm).

[0078] The guide tube 52 includes a distal portion 522 that is extendable from the side opening 53 of the delivery catheter 50 and from a retracted position to an extended position. The distal portion 522 forms a more 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.

[0079] The distal portion 522 of the guide tube 52 has the curved shape configured to direct the secondary guidewire 55 to advance through the second leg 22416DMSJJS.374303018.1such that the secondary guidewire 55 has a distal end 551 extending out of the second leg 224.

[0080] In some embodiments, the distal portion 522 of the guide tube 52 is formed of nitinol. It is to be understood that the distal portion 522 of the guide tube 52 can be formed of any suitable material configured to be self-bending / 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 side opening 53 of the delivery catheter 50. Prior to extension, the distal portion 522 may be maintained in a less curved shaped. In some embodiments, the delivery catheter 50 has a sufficiently resilient body to resist deformation due to the shape-set, self-bending property of the distal portion 522.

[0081] As shown, the guide tube 52 extends up in the lumen 51 of the delivery catheter 50 through the first leg 222 to exit the side opening 53 and curves down toward the second leg 224.

[0082] When the primary endoprosthesis 22 is in a compacted state, the distal portion 522 of the guide tube 52 is received inside the lumen 51 of the delivery catheter 50. When the primary endoprosthesis 22 is deployed from the compacted state to an expanded state, the distal portion 522 of the guide tube 52 is extended out of the side opening 53 of the delivery catheter 50 such that the distal portion 522 of the guide tube 52 takes on a curved configuration, curving down, or proximally, toward the second leg 224. 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 selfcurving feature described above.

[0083] In some embodiments, a second guide member (e.g., the second guide member 37 (e.g., a snaring guidewire) of FIG. 3C) can be provided to engage with the distal end 551 of the secondary guidewire 55. The second guide member can be directed through an external access site (e.g., the external access site 202 of FIG. 1), through the second branch 104 of the main vessel (e.g., through the external iliac artery and the common iliac artery), and engage with the distal end 551 of the secondary guidewire 55. The second guidewire can be pulled to direct the secondary guidewire 55 to extend through the second leg 224, through the second branch 104 of the main17DMSJJS.374303018.1vessel, and exit the external access site (e.g., the second external access site 202 of FIG. 1).

[0084] When the secondary guidewire 55 is pulled into place by the snaring guidewire, the distal portion 522 of the guide tube 52 can be retracted into the lumen 51 of the delivery catheter 50. The delivery catheter 50 can be then retracted from the body of the patient, along with the guide tube 52.

[0085] In some embodiments, an auxiliary endoprosthesis system can be moved into place over the secondary guidewire 55 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 secondary guidewire 55, within the second branch 104 of the main vessel, to contact with the second leg 224 of the primary endoprosthesis 22. The secondary endoprosthesis can be deployed so that a distal end of the secondary endoprosthesis expands into the second leg 224 of the primary endoprosthesis 22 to extend the second leg 224 into the second branch 104 of the main vessel. This cannulation process is now relatively easy given the secondary guidewire 55 to direct the auxiliary endoprosthesis system into place. The secondary guidewire 55 can be then fully withdrawn.

[0086] FIG. 6A illustrates an example endoprosthesis delivery system 600 including a cannulation fiber 64. The cannulation fiber 64 is routed through the first leg 222, around the trunk bifurcation 225, and through the second leg 224. An exchange catheter 62 is advanceable over the cannulation fiber 64 through the first leg 222 (FIG. 6B).

[0087] FIG. 7A illustrates a portion of the example exchange catheter 62, according to some embodiments. FIG. 7B illustrates a cross-sectional view of the example exchange catheter 62 of FIG. 7A, according to some embodiments. The exchange catheter 62 includes a first lumen 624 to receive the cannulation fiber 64, and a second lumen 626 to receive a secondary guidewire 65 (FIG. 6C).

[0088] As shown, the endoprosthesis delivery system 600 further includes a delivery catheter 60 which includes a lumen 61. The delivery catheter 60 is extendable through the first leg 222 of the primary endoprosthesis 22. The delivery catheter 60 further includes an opening 63 adjacent to the trunk bifurcation 225, facing the side of the second leg 224. In some embodiments, the cannulation fiber 64 and / or the exchange catheter 62 can be pre-loaded into the lumen 61 of the delivery catheter 60.18DMSJJS.374303018.1That is, the cannulation fiber 64 and / or the exchange catheter 62 may be introduced into the lumen 61 while the primary endoprosthesis 22 is still outside a patient, and before it has been introduced into the vasculature. In some embodiments, the cannulation fiber 64 can be routed through the first leg 222, through the opening 63, around the trunk bifurcation 225, through and out of the second leg 224, and back to the lumen 61 of the delivery catheter 60. In other embodiments, the cannulation fiber 64 may be pre-attached, or pre-loaded into the lumen 61 and the exchange catheter 62 can be subsequently (e.g., after the endoprosthesis is positioned in the patient) inserted through the lumen 61 over the cannulation fiber and out of the opening 63.

[0089] As shown, the exchange catheter 62 is in the form of a guide tube which is advanceable over the cannulation fiber 64 in the lumen 61 of the delivery catheter 60 and through the first leg 222. The exchange catheter 62 includes a distal portion 622 that is extendable over the cannulation fiber 64 from the opening 63 of the delivery catheter 60 to an extended position. The distal portion 622, as being guided by the cannulation fiber 64, forms a curved shape with a distal end 621 extending toward the second leg 224. In some embodiments, the distal end 621 of the distal portion 622 can extend into the second leg 224. In some embodiments, the distal end 621 of the distal portion 622 can point toward the second leg 224, without extending into the second leg 224.

[0090] In some embodiments, the distal portion 622 of the exchange catheter 62 is formed of nitinol. It is to be understood that the distal portion 622 of the exchange catheter 62 can be formed of any suitable material configured to be self- bending / bendable to form a curved shape. The distal portion 622 can be shape-set so that the distal portion 622 tends to self-bend into a curved shape when the distal portion 622 is unconstrained, such as when the distal portion 622 extends out from the opening 63 of the delivery catheter 60. Prior to extension, the distal portion 622 may be maintained in a less curved shaped. In some embodiments, the delivery catheter 60 has a sufficiently resilient body to resist deformation due to the shape-set, self-bending property of the distal portion 622.

[0091] In some embodiments, when the primary endoprosthesis 22 is in a compacted state, the distal portion 622 of the exchange catheter 62 can be received inside the lumen 61 of the delivery catheter 60. When the primary endoprosthesis 22 is deployed from the compacted state to an expanded state, the distal portion 622 of the19DMSJJS.374303018.1exchange catheter 62 is extended out of the opening 63 of the delivery catheter 60 over the cannulation fiber 64 such that the exchange catheter 62 takes on a curved configuration, curving down, or proximally, toward the second leg 224. In some embodiments, the distal portion 622 of the exchange catheter 62 has a steering mechanism (e.g., one or more pull wires) such that the distal portion 622 can be actuated by tensioning the steering mechanism, either in addition to, or as an alternative to the self-curving feature described above.

[0092] Referring again to FIG. 6B, the exchange catheter 62 is advanceable over the cannulation fiber 64, through the first leg 222, through the side opening 53, and may follow the cannulation fiber 64 to curve down toward the second leg 224. In this manner, the cannulation fiber 64 may be used to direct, or guide or redirect the exchange catheter 62 toward the second leg 224.

[0093] As shown in FIG. 6C, the curved shape of the distal portion 622 of the exchange catheter 62 is configured to direct the secondary guidewire 65 such that it may be advanced through the second leg 224 with the secondary guidewire 65 having a distal end 651 extending outside the second leg 224.

[0094] In some embodiments, a second guide member (e.g., the second guide member 37 (e.g., a snaring guidewire) of FIG. 3C) is provided with the system and may be used to engage with the distal end 651 of the secondary guidewire 65. The second guide member can be directed through an external access site (e.g., the access site 202 of FIG. 1), through the second branch 104 of the main vessel (e.g., through the external iliac artery and the common iliac artery) to engage the distal end 651 of the secondary guidewire 65. The second guidewire can be pulled using the second guide member to direct the secondary guidewire 65 to extend through the second leg 224, through the second branch 104 of the main vessel, and then exit from the external access site (e.g., the access site 202 of FIG. 1).

[0095] When the secondary guidewire 65 is pulled into place by the second guide member 37 (e.g., a snaring guidewire), the distal portion 622 of the exchange catheter 62 can be retracted over the cannulation fiber 64 into the lumen 61 of the delivery catheter 60. The exchange catheter 62 can then be retracted from the body of the patient and the cannulation fiber 64 can be removed via the delivery catheter 60, as shown in FIG. 6D.20DMSJJS.374303018.1

[0096] In some embodiments, an auxiliary endoprosthesis system can be moved into place over the secondary guidewire 65 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 secondary guidewire 65, within the second branch 104 of the main vessel, to contact with the second leg 224 of the primary endoprosthesis 22. The secondary endoprosthesis can be deployed so that a distal end of the secondary endoprosthesis expands into the second leg 224 of the primary endoprosthesis 22 to extend the second leg 224 into the second branch 104 of the main vessel. This cannulation process is facilitated by the presence of the secondary guidewire 65 which helps direct the auxiliary endoprosthesis system into place. Following delivery of the auxiliary endoprosthesis, the secondary guidewire 65 can be then fully withdrawn.

[0097] 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.21DMSJJS.374303018.1

Claims

WHAT IS CLAIMED IS:

1. An endoprosthesis for treating a target vascular location, the endoprosthesis comprising: a main body including a stent and a graft member coupled to the stent, the main body configured for implantation through an external access site in a body of a patient, the main body including a trunk that branches into a first leg and a second leg; a delivery tube extending coupled to the main body and extending within the main body, the delivery tube extending within the first and second legs such that the delivery tube extends up the first leg and down the second leg and the delivery tube has a curved shape, the delivery tube including an internal lumen; and a guide member advanceable in the internal lumen of the delivery tube into the first leg and out of the second leg.

2. The endoprosthesis of claim 1 , wherein the delivery tube is formed of film material.

3. The endoprosthesis of claim 1 or 2, wherein the delivery tube is coextensive with the first and second legs.

4. The endoprosthesis of any one of claims 1-3, wherein the delivery tube has a first tube end, the first leg has a first leg end, and the first tube end is coterminous with the first leg end.

5. The endoprosthesis of claim 4, wherein the delivery tube has a second tube end, the second leg has a second leg end, and the second tube end is aligned with the second leg end.

6. The endoprosthesis of any one of claims 1-5, wherein at least a portion of the delivery tube is formed of reinforced material.

7. The endoprosthesis of any one of claims 1-6, wherein:22DMSJJS.374303018.1when the main body is in a compacted state having a lower outer profile than an expanded state of the main body, the delivery tube is in a compacted configuration; and when the main body is deployed from the compacted state to the expanded state, the delivery tube is in an expanded configuration having a greater outer profile than the compacted configuration of the delivery tube.

8. The endoprosthesis of any one of claims 1-7, wherein the delivery tube is releasably attached to the main body within the first and second legs.

9. A delivery system for delivering an implantable medical device to a target vascular location, the system comprising: a primary endoprosthesis configured for implantation through an external access site in a body of a patient, the primary endoprosthesis including a trunk that branches into a first leg and a second leg; a delivery catheter extending through the first leg of the primary endoprosthesis and including a lumen; a hollow guide member advanceable in the lumen of the delivery catheter; and a secondary guidewire receivable within the hollow guide member, wherein the hollow guide member comprises a distal portion configured to extend out of the delivery catheter to transition from a longitudinally-elongated state to a curved state.

10. The delivery system of claim 9, wherein: the distal portion of the hollow guide member has the curved shape configured to direct the secondary guidewire to advance through the second leg, and the secondary guidewire has a distal end extending out of the second leg.

11. The delivery system of claim 10, further comprising a snaring guidewire to engage with the distal end of the secondary guidewire.

12. The delivery system of any one of claims 9-11 , wherein the distal portion of the hollow guide member is formed of nitinol.23DMSJJS.374303018.

113. The delivery system of any one of claims 9-12, wherein: the delivery catheter includes a tip, and the hollow guide member is configured to extend up in the lumen of the delivery catheter to exit the tip, and the distal portion curves down toward the second leg upon exiting the tip.

14. The delivery system of any one of claims 9-13, wherein: when the primary endoprosthesis is in a compacted state, the distal portion of the hollow guide member is received inside the hollow guide member; and when the primary endoprosthesis is deployed from the compacted state to an expanded state, the distal portion of the hollow guide member extends out of the delivery catheter to form the curved shape.

15. A delivery system for delivering an implantable medical device to a target vascular location, the system comprising: a primary endoprosthesis configured for implantation 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; a delivery catheter extendable through the first leg of the primary endoprosthesis and including a lumen and a side opening; a guide tube advanceable in the lumen of the delivery catheter; and a secondary guidewire receivable within the guide tube, wherein the guide tube comprises a distal portion that is extendable from the side opening of the delivery catheter from a retracted position to an extended position, and wherein the distal end portion transitions to a curved shape in the extended position.

16. The delivery system of claim 15, wherein: the distal portion of the guide tube has the curved shape configured to direct the secondary guidewire to advance through the second leg, and the secondary guidewire has a distal end extending out of the second leg.24DMSJJS.374303018.

117. The delivery system of claim 16, further comprising a snaring guidewire to engage with the distal end of the secondary guidewire.

18. The delivery system of any one of claims 15-17, wherein the distal portion of the guide tube is formed of nitinol.

19. The delivery system of any one of claims 15-18, wherein the guide tube extends up in the lumen of the delivery catheter to exit the side opening and curves down toward the second leg.

20. The delivery system of any one of claims 15-19, wherein: when the primary endoprosthesis is in a compacted state, the distal portion of the guide tube is received inside the lumen of the delivery catheter; and when the primary endoprosthesis is deployed from the compacted state to an expanded state, the distal portion of the guide tube extends out of the delivery catheter to form the curved shape.

21. A delivery system for delivering an implantable medical device to a target vascular location, the system comprising: a primary endoprosthesis configured for implantation 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; a cannulation fiber extending through the first leg, around the bifurcation, and through the second leg; an exchange catheter advanceable over the cannulation fiber through the first leg; and a secondary guidewire receivable within the exchange catheter, wherein the exchange catheter comprises a distal portion that is extendable over the cannulation fiber to form a curved shape toward the second leg.

22. A method of treating a target vascular location, the method comprising:25DMSJJS.374303018.1delivering an endoprosthesis through an external access site in a body of a patient at a location proximate a bifurcation of a main vessel into a first branch and a second branch, wherein the endoprosthesis comprises: a main body including a stent and a graft member coupled to the stent, the main body further including a trunk that branches into a first leg and a second leg; a delivery tube extending coupled to the main body and extending within the main body, the delivery tube extending within the first and second legs such that the delivery tube extends up the first leg and down the second leg and the delivery tube has a curved shape, the delivery tube including an internal lumen; and a guide member advanceable in the internal lumen of the delivery tube into the first leg and out of the second leg.26DMSJJS.374303018.1

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