MULTI-COMPONENT DELIVERY SYSTEMS AND METHODS

A method of deploying a multibranch stent graft at a target site having a main lumen and a first branch lumen is provided. The method includes advancing a catheter including a main body having a first portion and a second portion, the main body defining a first portal being pre-cannulated with a first guide member, partially deploying the first portion of the main body, advancing a first sheath along the first guide member through the first portal, advancing a first articulatable wire through the first sheath, positioning the first articulatable wire into a first branch lumen of the target site, partially deploying the second portion of the main body, fully deploying the first portion and the second portion of the main body, advancing a first side branch body along the first articulatable wire into the first branch lumen, and deploying the first side branch body in the first branch lumen.

FIELD

The present disclosure relates generally to systems and methods for delivering multi-component devices. More specifically, the disclosure relates to systems and methods for delivering endovascular devices that include individual components to a target site.

BACKGROUND

A variety of branched, anatomical passages may benefit from treatment in the form of an implanted, endoluminal device. One such passage is a vascular passage, such as an artery, with an aneurysm. Aortic disease and trauma such as aneurysms and dissections present a significant risk to a patient. That risk is increased based on the patient's condition. Such conditions or factors can include the patient's age and preexisting and/or related conditions such as cardiopulmonary bypass, cardiac arrest, circulatory arrest. These and other factors may limit the patient's ability to withstand and recover from surgery to repair the aortic disease. This same issue exists in other diseased and damaged tissues in the patients.

With respect to aneurysms, in order to prevent rupturing of an aneurysm, a stent graft may be introduced into a blood vessel percutaneously and deployed to span the aneurysmal sac. Stent grafts include a graft fabric secured to a cylindrical scaffolding or framework of one or more stents. The stent(s) provide rigidity and structure to hold the graft open in a tubular configuration as well as the outward radial force needed to create a seal between the graft and a healthy portion of the vessel wall and provide migration resistance. Blood flowing through the vessel can be channeled through the luminal surface of the stent graft to reduce, if not eliminate, the stress on the vessel wall at the location of the aneurysmal sac. Stent grafts may reduce the risk of rupture of the blood vessel wall at the aneurysmal site and allow blood to flow through the vessel without interruption.

Various endovascular repair procedures such as the exclusion of an aneurysm require a stent graft to be implanted adjacent to a vascular bifurcation. Often the aneurysm extends into the bifurcation requiring the stent graft to be placed into the bifurcation. A bifurcated stent graft is therefore required in these cases. Modular stent grafts, having a separate main body and branch component are often preferred in these procedures due to the ease and accuracy of deployment. See U.S. Patent Application No. 2008/0114446 to Hartley et al. for an example of a modular stent graft having separate main body and branch stent components. In the Hartley et al. publication the main body stent has a fenestration in the side wall that is tailored to engage and secure the side branch stent.

SUMMARY

An endoprosthesis including a main body is provided with side branch portals for providing fluidic access to side branches of a main lumen when the main body of the endoprosthesis is deployed in the main lumen. A method of deployment of the endoprosthesis is also provided

According to one example (“Example 1”), a method of deploying includes a multibranch stent graft at a target site having a main lumen and a first branch lumen is provided, the method including advancing a main guidewire to a target site; advancing a catheter including a main body of a multibranch stent graft along the main guidewire toward the main lumen of the target site, the main body having a first portion and a second portion, the main body defining a first portal operable to provide fluidic access from the main body to a first side branch extending from the target site when the main body is deployed at the target site, the first portal being pre-cannulated with a first secondary guidewire prior to advancing the main body along the main guidewire; partially deploying the first portion of the main body in the main lumen of the target site; advancing a first sheath along the first guide member through the first portal; advancing a first articulatable wire or guide catheter through the first sheath; positioning the first articulatable wire or guide catheter into a first branch lumen of the target site; partially deploying the second portion of the main body in the main lumen of the target site; fully deploying the first portion and the second portion of the main body; advancing a first side branch body along the first articulatable wire or guide catheter into the first branch lumen of the target site; and deploying the first side branch body in the first branch lumen of the target site.

According to another example (“Example 2”), further to Example 1, the method includes deploying an embolic filter in the first branch lumen of the target site.

According to another example (“Example 3”), further to Example 2, the method includes aspirating a filter sheath of the embolic filter.

According to another example (“Example 4”), further to Example 3, the method includes removing the embolic filter after the first side branch body has been deployed.

According to another example (“Example 5”), further to any of the preceding Examples, wherein the first guide member includes a first end that is looped around a cap of the catheter.

According to another example (“Example 6”), further to any of the preceding Examples, wherein the main body further defines a second portal and a third portal operable to provide fluidic access from the main body to a second side branch and a third side branch extending from the target site when the main body is deployed at the target site, the second portal being pre-cannulated with a second guide member and the third portal being pre-cannulated with a third guide member prior to advancing the main body along the main guidewire.

According to another example (“Example 7”), further to Example 6 further includes advancing a second sheath along the second guide member through the second portal; advancing a second articulatable wire or guide catheter through the second sheath; positioning the second articulatable wire or guide catheter into a second branch lumen of the target site; advancing a third sheath along the third guide member through the third portal; advancing a third articulatable wire or guide catheter through the third sheath; and positioning the third articulatable wire or guide catheter into a third branch lumen of the target site.

According to another example (“Example 8”), further to Example 7, the method includes advancing a second side branch body along the second articulatable wire or guide catheter into the second branch lumen of the target site; deploying the second side branch body in the second branch lumen of the target site; advancing a third side branch body along the third articulatable wire or guide catheter into the third branch lumen of the target site; and deploying the third side branch body in the third branch lumen of the target site.

According to another example (“Example 9”), further to Example 8, the method further includes removing the main guidewire, the first, second, and third guide members, and the first, second, and third sheaths.

According to another example (“Example 10”), further to Example 9, wherein the catheter is removed prior to advancing the first, second, and third sheaths.

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

According to another example (“Example 12”), further to Example 11, the endoprosthesis delivery system further includes a constraining member constraining the main body of the endoprosthesis to the elongate member.

According to another example (“Example 13”), further to Example 12, the endoprosthesis delivery system, wherein the constraining member is operable to constrain the main body at a constrained configuration and at a partially deployed configuration, the main body having a first diameter at the constrained configuration, a second diameter at the partially deployed configuration that is greater than the first diameter, and a third diameter at a deployed configuration that is greater than the first diameter and the second diameter.

According to another example (“Example 14”), further to Example 13, the endoprosthesis delivery system, wherein the constraining member includes a first portion and a second portion, wherein the first portion and the second portion are operable to independently constrain corresponding first and second portions of the main body at the constrained configuration and the partially deployed configuration.

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

According to another example (“Example 16”), further to Example 15, the endoprosthesis delivery system further includes an articulatable wire or guide catheter operable to be advanced through the sheath.

According to another example (“Example 17”), further to Example 16, the endoprosthesis delivery system further includes at least one secondary branch operable to be advanced along the articulatable wire or guide catheter and to be deployed at least partially within the at least one side branch portal.

According to another example (“Example 18”), further to Example 17, the endoprosthesis delivery system further includes a removeable filter operable to be deployed downstream from a target site of the endoprosthesis.

According to another example (“Example 19”), further to Example 18, the endoprosthesis delivery system wherein the removeable filter includes a central lumen through which the articulatable or guide catheter wire is operable to extend.

According to another example (“Example 20”), further to any one of Examples 11-19, the endoprosthesis delivery system, wherein the end cap is curved.

According to another example (“Example 21”), further to the endoprosthesis delivery system of any one of Examples 11-20, wherein the endoprosthesis delivery system is curved from the end cap through the main body.

According to another example (“Example 22”), an endoprosthesis delivery system includes an elongate member having a first end and a second end; an endoprosthesis positioned longitudinally between the first end and second end of the elongate member, the endoprosthesis including a main body defining a main lumen and a side branch portal; a guide member extending through the side branch portal; and a guide member retainer removably coupled to the elongate member at a coupling position, the guide member being coupled to the guide member retainer at a position between the side branch portal and the coupling position of the guide member retainer.

According to another example (“Example 23”), further to the endoprosthesis delivery system of Example 22, wherein the main body defines a plurality of side branch portals.

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

According to another example (“Example 25”), further to the endoprosthesis delivery system of any one of Examples 22-24, wherein the guide member retainer extends through loops formed at an end of each of the guide members.

According to another example (“Example 26”), further to Example the endoprosthesis delivery system of any one of Examples 22-25, wherein the guide member retainer is operable to be selectively decoupled from the first coupling position.

According to another example (“Example 27”), further to the endoprosthesis delivery system of any one of Examples 22-26, wherein the elongate member includes a lock wire retainer positioned at the first end of the elongate member.

According to another example (“Example 28”), further to the endoprosthesis delivery system of Example 27, wherein the guide member retainer is releasably coupled to the lock wire retainer.

According to another example (“Example 29”), further to the endoprosthesis delivery system of any one of Examples 22-28, further including a side branch body, wherein each guide member includes a first end, wherein each first end of the guide members is retained by the guide member retainer between the coupling position and the side branch portal when the side branch body is advanced along the guide member.

According to another example (“Example 30”), further to the endoprosthesis delivery system of any one of Examples 22-29, wherein each guide member is operable to be removed from a corresponding side branch portal when the guide member retainer is released.

According to another example (“Example 31”), further to the endoprosthesis delivery system of any one of Examples 22-30, further including a plurality of guide member retainers, wherein each guide member retainer is coupled to a corresponding guide member.

According to another example (“Example 32”), further to the endoprosthesis delivery system of Example 29, wherein each guide member retainer is operable to be individually and selectively released from engagement at the first coupling position such that each guide member is operable to be individually removed from a corresponding side branch portal.

According to another example (“Example 33”), further to the endoprosthesis delivery system of Example 22, wherein the elongate member includes a cap positioned at the first end of the elongate member, wherein the guide member retainer is coupled to the cap at the coupling position.

According to another example (“Example 34”), further to the endoprosthesis delivery system of any one of Examples 22-33, the guide member retainer is coupled to the elongate member at the first end of the elongate member.

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.

DETAILED DESCRIPTION

Definitions and Terminology

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.

Certain relative terminology is used to indicate the relative position of components and features. For example, words such as “top”, “bottom”, “upper,” “lower,” “left,” “right,” “horizontal,” “vertical,” “upward,” and “downward” are used in a relational sense (e.g., how components or features are positioned relative to one another) and not in an absolute sense unless context dictates otherwise. Similarly, throughout this disclosure, where a process or method is shown or described, the method may be performed in any order or simultaneously, unless it is clear from the context that the method depends on certain actions being performed first.

With respect to terminology of inexactitude, the terms “about” and “approximately” may be used, in certain instances, 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.

As used herein, “couple” means join, connect, attach, adhere, affix, or bond, whether directly or indirectly, and whether permanently or temporarily.

As used herein, the term “elastomer” refers to a polymer or a mixture of polymers that has the ability to be stretched to at least 1.3 times its original length and to retract rapidly to approximately its original length when released. The term “elastomeric material” refers to a polymer or a mixture of polymers that displays stretch and recovery properties similar to an elastomer, although not necessarily to the same degree of stretch and/or recovery. The term “non-elastomeric material” refers to a polymer or a mixture of polymers that displays stretch and recovery properties not similar to either an elastomer or elastomeric material, that is, considered not an elastomer or elastomeric material as is generally known.

The term “film” as used herein generically refers to one or more of the membrane, composite material, or laminate.

The term “biocompatible material” as used herein generically refers to any material with biocompatible characteristics including synthetic materials, such as, but not limited to, a biocompatible polymer, or a biological material, such as, but not limited to, bovine pericardium. Biocompatible material may comprise a first film and a second film as described herein for various embodiments.

For reference, the terms “circumference” and “diameter” are not meant to require a circular cross-section (although are inclusive of a circular cross-section), and are instead to be understood broadly to reference an outer surface or dimension and the dimension between opposing sides of the outer surface, respectively.

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

Description of Various Embodiments

Devices, systems, and methods of endoluminally delivering a branchable expandable implant in accordance with various embodiments are disclosed herein for treating disease of human vasculature. Although the description below and figures are illustrated in the context of treating the aorta20, including the ascending aorta21, aortic arch22, and descending aorta23, and branches therefrom, including the brachiocephalic artery24, the left common carotid artery25, and the left subclavian artery26, it should be appreciated that the present disclosure can be applied to treatment of other portions of the vasculature or, including, for example, any disease where a larger vessel and one or more branch vessels are to be treated.

Referring toFIG.2, an implantable device10can be delivered and deployed in the aorta20, the implantable device10including a main body100and branch bodies200. The main body100is deployed in the aortic arch22and the branch bodies200can be deployed in branching arteries (e.g., a first branch body200ain the brachiocephalic artery24, a second branch body200bin the left common carotid artery25, and a third branch body200cin the left subclavian artery26).

Although various configurations of the implantable device10are contemplated with respect to the delivery systems and methods described herein, several discrete examples of an implantable device10are provided in detail in order to provide reference for the various components and steps of the delivery system and method of delivery and deployment. For example,FIG.3is an exemplary embodiment of an implantable device10. The main body100includes a wall104forming the main lumen102. The main body100has a first end106and a second end108. At the first end106, the main body100includes a first opening107and at the second end108the main body100includes a second opening109. Each of the openings107,109provides access to the main lumen102at the corresponding end106,108. Fluids are operable to flow through the main lumen102by passing through the first opening107, into the main lumen102, and out the second opening109, defining a main body fluid flow direction. Or, the flow may be in the opposite direction, defining the main body fluid flow direction. The outer wall104substantially forms or defines the outer profile of the main body100.

In some embodiments, the main body100is formed of a stent structure120and a graft member130. The stent structure120is operable to maintain patency of the main body100and/or the main vessel (e.g., the aorta20) when the main body100is deployed. The stent structure120can be formed of various materials, including, but not limited to, metals, metal alloys, polymers, and any combination thereof to provide elastic or plastic properties (e.g., self-expanding or balloon-expandable stents). The graft member130is coupled to the stent structure120and forms the fluid impermeable or semi-permeable layer through which fluids may flow (e.g., blood).

The main body100further includes at least one side branch portal110. The side branch portal110is operable to provide fluidic access between the main lumen102and a branch vessel. The side branch portal110forms or is positioned in an opening112through the wall104along the outer profile of the main body100. In certain instances, the side branch portal110extends through the wall104of the main body100longitudinally between the first end106and the second end108of the main body100. Thus, fluid may flow through the first opening107and through the side branch portal110. Some embodiments include a plurality of side branch portals110. For example,FIG.3illustrates a main body100included a first side branch portal110a, a second side branch portal110b, and a third side branch portal110c. Any number of side branch portals110may be incorporated to accommodate the specific anatomy into which the device10is to be deployed.

Referring still toFIG.3, in some embodiments, each of the side branch portals110includes a side branch stent structure114and a side branch graft member116. In various embodiments, the side branch stent structure114and side branch graft member116can be independent from, incorporated into, or integral with the main body stent structure120and the main body graft member140. For example, as illustrated inFIGS.3-5, the side branch stent structures114is separate or independent from the main body stent structure120, whereas the side branch graft member116is incorporated into the main body graft member140(e.g., sandwiched or interposed between layers of the main body graft member140). In some embodiments, the side branch stent structure114extends from the main body stent structure130and therefore represents a portion of the main body stent structure130rather than an independent stent structure. In still other embodiments, the side branch stent structure114is coupled to the main body stent structure130. Similarly, the side branch graft member116can be formed directly from the main body graft member140and therefore represent a portion of the main body graft member140. In other embodiments, the side branch graft member116is coupled to the main body graft member140or, or in still other embodiment, is spaced from the main body graft member140. It is understood that any combination of side branch stent structures114and side branch graft member116embodiments is within the scope of this disclosure.

In some embodiments, the side branch portal110is positioned between the first end106and the second end108of the main body100and does not extend beyond or increase the outer profile of the main body100(seeFIGS.4and5). Stated otherwise, the portion of an outer wall of the side branch portal110is positioned along the wall104of the main body100within the outer profile of the main body100(e.g., flush with the outer profile). Thus, the side branch portal110may extend into the main lumen102of the main body100without substantially increasing the outer profile of the main body100adjacent the exit location of the side branch portal110from the main body100.

Each side branch portal110may be include a first end118and a second end122defining a first opening119and a second opening121, respectively. Fluids travel through the side branch portal from the first end118to the second end122(or vice versa) defining a side branch fluid flow direction. The side branch portal110is positioned such that the first opening119is positioned within or oriented toward the main lumen102of the main body100and the second opening121is positioned exterior to or oriented away from the main body100(e.g., the first opening119is the interior opening and the second opening121is the exterior opening of the side branch portal110relative to the wall104and main lumen102of the main body100). For example,FIG.5illustrates those embodiments in which the first opening119of the side branch portal110is positioned within the main lumen102. The side branch portal110may have various longitudinal lengths. Furthermore, when a plurality of side branch portals110are implemented, each side branch portal110may include various lengths or may be uniform in length. It is understood that in embodiments implementing a plurality of side branch portals110, each side branch portal110may have an independent diameter or geometric orifice area.

In some embodiments, the side branch portal110is oriented such that the side branch fluid flow direction is opposite to the main body fluid flow direction (e.g., retrograde to the main body fluid flow direction). It is understood that opposite or retrograde in these embodiments is not limited to 180 degrees of difference, but generally encompasses a change in the direction of the fluid flowing that is greater than 90 degrees. It is also understood that the direction of the fluid flow is with respect to the specific location along the longitudinal length of the main body100as the main body may conform to a curved anatomy. For example, in embodiments where the side branch fluid flow direction is opposite or retrograde to the main body fluid flow includes those embodiments in which the side branch portal110second opening121is longitudinally closer to the main body100first end106relative to the side branch portal110first opening119. By orienting the side branch portal110in the retrograde orientation, a surgeon may be able to perform the intervention and any subsequent interventions from a more advantageous access site (e.g., femoral access site to reduce trauma to carotid arteries, subclavian, or other arteries or decrease surgical presence in more anatomically crowded portions of a patient such as around the neck or thorax when operating in the aortic arch). This orientation may be advantageous in some presentations where access may difficult, obstructed, or dangerous from certain access sites.

In other embodiments, the side branch portal110is oriented such that the side branch fluid flow direction is generally oriented with the main body fluid flow direction (e.g., antegrade to the main body fluid flow direction). In embodiments where the side branch fluid flow direction is antegrade to the main body fluid flow includes those embodiments in which the side branch portal110first opening119is longitudinally closer to the main body100first end106relative to the side branch portal110second opening121. Antegrade orientations may be advantageous in some embodiments to maintain more traditional fluid flow, especially in tissues or anatomies that may have unique geometries that would limit the use of a retrograde orientation. In embodiments implementing a plurality of side branch portals110, the side branch portal may all have an antegrade orientation, may all have a retrograde orientation, or may include one or more branch portals with an antegrade orientation and one or more portals having a retrograde orientation.

The second opening121of the side branch portal110can be positioned at various longitudinal positions between the first end106and the second end108of the main body100. For example, the second opening121of the side branch portal110may be positioned generally at the midpoint between the first and second ends106,108of the main body100. In other embodiments, the second opening121of the side branch portal110may be positioned closer to the first end106relative the second end108or, alternatively, closer to the second end108relative to the first end106of the main body100. In those embodiments including a plurality of side branch portals110, each second opening121may be aligned longitudinally along the length of the main body100(seeFIG.3), staggered along the length of the main body100(seeFIG.7), or a combination thereof (seeFIG.8).

The side branch portals110may be incorporated into the main body100in variety of ways. For example, the side branch portals110may be wrapped between layers of film in the graft member130. It is noted that in those embodiments in which a plurality of side branch portals110are implements, a plug (not shown) may be inserted into any one or multiple side branch portals110if one or more of the side branch portals are not needed in a particular application. For example, a device10may include three side branch portals110, but only two are needed fora patient (e.g., in the aortic arch with a bypass), one of the side branch portals110may be closed (e.g., via a plug).

In some embodiments, the stent structure120extends around an outer periphery of the side branch portals110. In embodiments implementing a side branch stent structure114that may implement materials that are more discreet or provide less holding or expansion force than the main body stent structure120, the stent structure120may extend around the side branch portals110to limit collapsing of the side branch portals110(and side branch stent structures114when included) during delivery, deployment, and used of the device10. However, in some embodiments, the stent structure120does not extend around the side branch portals110.

Referring now toFIG.4, the main body100includes a portal access feature150. The portal access feature150is operable to provide clearance for branch bodies200that are at least partially positioned and deployed within the side branch portal110. For example, the portal access feature150may be a portion of the wall104of the main body100that has a recessed outer profile. For example, inFIG.4, the main body100as illustrated includes a substantially circular cross-section along the longitudinal length of the main body100except at the longitudinal lengths of the main body100defining the portal access feature150.FIG.5illustrates the main body100from a side view looking through the main lumen102. In this view, the substantially circular outer profile is illustrated. This view also depicts the profile of the main body at the portal access feature150. The main body100at the portal access feature150includes a cross-section that is substantially circular with a truncated or chord portion152of the wall104extending from a first position154of the wall104across to a second position156of the wall104. As illustrated, the portal access feature150deviates from the typical outer profile of the remainder of the main body100such that the portal access feature150appears to be radially inward from the remainder of the main body100.

Referring again toFIG.4, the portal access feature150is defined in the wall104of the main body100from at least the second opening121of the side branch portal110toward the first end106of the main body. The depth158of the portal access feature150is substantially equal to diameter of the side branch portal110. The portal access feature150may extend from the second opening121of the side branch portal110at the depth158for a predetermined length to define the entry portion160. The predetermined length of the entry portion160can provide sufficient space for the branch body200to exit the side branch portal110and turn or bend toward the branch vessel and defines an entry portion160of the portal access feature150. The entry portion160in some embodiments is substantially flat, as is illustrated inFIG.4. However, the entry portion160, in some embodiments, can incorporate a curvature. For example, in some embodiments, the entry portion160includes an arcuate profile. The arcuate profile may allow a plurality of side branch portals110to be implemented (e.g., each side branch portal110having the same diameter), where a bottom edge of each side branch portal110aligns with the entry portion160of the portal access feature150and the top edge aligns with the outer profile of the main body100(not shown). The portal access feature150may also include a transition portion162. The transition portion162includes the portion of the wall104that transitions into the entry portion160. The transition portion162may also be operable to accommodate the branch body200as it exits the side branch portal110. In some embodiments, the transition portion162extends directly from the second opening121of the side branch portal110(not shown). In still further embodiments, the portal access feature150is a narrowing (not shown) of the main body100proximate the second opening121of the side branch portal110.

It is understood that the portal access feature150does not have to begin at the second opening121of the side branch portal110. For example, in some embodiments, the portal access feature150extends beneath the side branch portals110. The side branch portals may be positioned between the portal access feature150and an outer layer of the graft member130. In these embodiments, the portal access feature150extends from the side branch portal110toward the first end106of the main body100.

With further reference toFIG.4, the portal access feature150, in some embodiments, the portal access feature is free of any stent. In some embodiments, the stent structure120used to support the graft member130does not extend onto the portal access feature150. For example, in those embodiments in which the stent structure120is helically wound, the stent structure120does not extend across the portal access feature150, but instead has a longitudinal portion that extends along the length of the main body100proximate the portal access feature150and extends away from the portal access feature150at each end of the longitudinal portion. It is understood that the stent structure120can include various features such as apices170, sinusoidal shapes and so forth while generally still being helically wound. In other embodiments, the stent structure120may include a plurality of independent rings that are longitudinally spaced along the length of the main body100. The rings of the stent structure120that are positioned at a shared longitudinal length of the main body100with the portal access feature150may terminate proximate the portal access feature150instead of extending fully around the main body100, or may include a longitudinal portion that connects rings as discussed with respect to helical winding.

In other embodiments, the stent structure120can extend across the portal access feature150. For example, in an embodiment in which the stent structure120extends across the portal access feature150, the stent structure can be formed and/or shape set to accommodate and/or form the profile of the portal access feature150. The portion of the stent structure120defined over the portal access feature150may be continuous with the remainder of the stent structure120. For example, in main bodies100implementing a stent structure120that is helically disposed or wrapped about the main body100, the stent structure120may substantially continue the helical path at the portal access feature150. In some embodiments, the apices170aof the stent structure120at the portal access feature150may be shorter than the apices170baround the remainder of the main body100(seeFIG.7). Furthermore, the frequency may be decreased such that more apices are incorporated into a circumferential length of the main body100at the portal access feature150. In other embodiments, the stent structure120positioned at the portal access feature150is shaped to outline or otherwise conform to the peripheral profile of the portal access feature150. In these embodiments, the stent structure120of the portal access feature150extends from or is coupled to the stent structure120of the remainder of the main body100, but has a shape independent from or not conforming to the pattern of the stent structure120of the remainder of the main body100.

In some embodiments, the portal access feature150may include a portal access stent (not shown) that is independent from the stent structure120as previously discussed. The independent stent member can is coupled to the graft member130at the portal access feature150. The independent stent member can incorporate any number of configurations, including patterns operable to conform to the peripheral profile of the portal access feature150.

The portal access feature150may further include a reinforcing material. The reinforcing material is operable to provide increased strength to the portal access feature150. The reinforcing material can resist tear, puncture, and other damage that can be incurred by the portal access feature150as the device10is being deployed. For example, cannulation and/or delivery and deployment of the branch body200may result in contacting the portal access feature, the reinforcing material being sufficiently sturdy to withstand tears or wear that could result in damage to the device10. In some embodiments, the reinforcing material is applied to the portal access feature, is incorporated into the graft member130at the portal access feature, or a combination thereof. Various materials may be implemented for the reinforcement material, including but not limited to dense ePTFE layers or multilayers.

Delivery System and Methods of Delivery and Deployment

Referring toFIG.1, a delivery system1000is illustrated (not necessarily to scale). The delivery system1000is operable to deliver a multi-component implantable device (e.g., implantable device10) to a target site. The delivery system includes a handle1100, an elongate member1200having a first end1202coupled to and/or extending from the handle1100and a second end1204, a cap1300positioned proximate the second end1204of the elongate member1200, and at least one guide member1400extending at least partially along the elongate member1200toward the cap1300. The elongate member1200and cap1300are operable to translate along a main guidewire1500(seeFIG.10). The delivery system1000can further include at least one sheath1600(seeFIGS.13a-13c), the sheath1600operable for use with the guide member1400(when there are a plurality of guide members1400a,1400b,1400c, each guide member1400has a corresponding sheath1600). An articulatable secondary guidewire1700(seeFIG.14) can be included for each sheath1600. The delivery system1000may also include a constraining member1800(seeFIG.11) that is operable to constrain at least a portion of a multi-component implantable device. It is understood that an individual constraining member1800may be implemented for each discrete component of the multi-component implantable device. The delivery system1000can be used in conjunction with filtration systems2000(e.g., to reduce risk of embolism, seeFIG.10). In some embodiments, the constraining member1800may include a window1802for the side branch portals110, the window1802of the constraining member1800positioned overlaying the side branch portals such that the side branch portals110are accessible when the constraining member1800is constraining the device10(seeFIG.24).

Referring toFIG.9, an exemplary target site for delivery and deployment of a multi-component implantable device is illustrated. In this example, the aorta20is illustrated. However, it is understood that the delivery system1000may be implemented in any part of the vasculature that includes branched lumens as appropriate. In this example, the aorta20is illustrated, including the ascending aorta21, aortic arch22, and descending aorta23, and branches therefrom, including the brachiocephalic artery24, the left common carotid artery25, and the left subclavian artery26.

FIG.10illustrates implementation of the filtration system2000in connection with the delivery system1000. The filtration system2000can include a plurality of deployable filters2002that can be deployed in discreet lumens, including side branch lumens, that are fluidically downstream from the target site at which the multi-component implantable device is to be implanted. The filtration system2000can be intermittently flushed throughout the procedure. A main guidewire1500is advanced to the target site (e.g., the aortic arch). Although the main guidewire1500is illustrated as coming from the descending aorta23(e.g., from a femoral access site), the main guidewire1500can be inserted from any appropriate access site.

Referring toFIG.11, a multi-component implantable device is advanced to the target site via the guidewire1500. For the purposes of the example provided herein, the multi-component implantable device will include the embodiment disclosed with respect toFIGS.3-4. However, it is understood that the methods and the delivery system1000are not limited to delivering only the implantable device10as described with reference toFIGS.3and4. The implantable device (e.g., the main body100) is positioned on the elongate member1200. For example, the implantable device10may be constrained in a compressed configuration about the elongate member1200. For example, the implantable device10can be constrained by a constraining member1800. The implantable device10may be positioned proximate the cap1300and the second end1204of the elongate member1200.

As is illustrated inFIG.11A, the delivery system1000may include a plurality of guide members1400a,1400b,1400c. The guide members1400a,1400b,1400care coupled (e.g., releasably coupled) to the delivery system1000proximate the second end1204of the elongate member1200. For example, in some embodiments, the guide members1400a,1400b,1400care coupled to the cap1300. The guide members1400a,1400b,1400cmay each form a loop1402(one of which is referenced inFIG.11Afor ease of illustration) which can be fastened to or disposed about at least a portion of the cap1300. In other embodiments, the guide members1400a,1400b,1400cmay implement a coupling system (not shown) for coupling the guide members1400to the to the delivery system1000proximate the second end1204of the elongate member1200, the coupling system including a feature, for example a ball tip, that is received by a corresponding member proximate the second end1204of the elongate member1200(e.g., the cap1300positioned proximate the second end1204of the elongate member1200may include a corresponding member). Other examples of embodiments for matingly engaging or coupling the guide members1400a,1400b,1400cat an end of the delivery system1000proximate the second end1204of the elongate member1200can be achieved by a variety of coupling arrangements, including press fitting, threads, ball and detent, articulating clips or jaws, hook and loop, and magnetic. Any number of methods and structures may be implemented for fastening the guide members1400a,1400b,1400cproximate the second end1204of the elongate member1200, and the disclosed embodiments are not to be limiting to the scope of the disclosure. It is also understood that the guide members1400can be fastened at various other positions on the delivery system1000. For example, in some embodiments, the guide member1400may be fixed to the elongate member1200or other portions of the delivery system1000. In some embodiments, the guide members1400are fastened to an internal wall of the main body100(e.g., via a releasable suture). In some embodiments, the guide members1400can be retained at a position via a lock wire retainer1902, which is described in further detail hereafter. The lock wire retainer1902may be implemented solely for capturing the guide members1400or may be used in connection with other members for various other purposes, including but not limited to steering and positioning the main body100at the target site, which will be described hereafter. Further examples for coupling the guide members1400with the delivery system1000are provided hereafter and are discussed with regard toFIGS.27A-27C.

Referring toFIG.11B, in some embodiments, a guide member retainer1980can be implemented with respect to the guide members1400in order to retain the guide members1400during delivery of the implantable device10and advancement of the sheaths1600along the guide members1400. For example, as illustrated in FIG.11B, the delivery system1000includes an elongate member1200having a first end1202. At the first end1202, the delivery system includes a lock wire retainer1902and an end cap1300(e.g., the lock wire retainer1902is positioned between the end cap1300and the first end1202of the elongate member1200). The main body100is positioned about the elongate member1200where the second region3002of the main body100is partially deployed and the first region3000is constrained. Guide members1400are extending through the side branch portals110toward the first end1202of the elongate member1200. The guide members1400include a retaining member at the end of each guide member1400(e.g., loops1402). The guide member retainer1980is releasably coupled to the lock wire retainer1902and extends along the elongate member1200. The guide member retainer1980is operable to retain the guide members1400at or proximate the first end1202of the elongate member1200(e.g., at the lock wire retainer1902, proximate the cap1300, etc.). The guide member retainer1980may be releasably coupled to the delivery system1000at a coupling position, for example, releasably and selectively coupled to the lock wire retainer1902. The guide member retainer1980may capture, lasso, or otherwise retain the guide members1400at a longitudinal position relative to the elongate member1200such that the guide members1400are restricted from being retracted along the longitudinal length of the elongate member1200. For example, the guide member retainer1980is fixedly coupled to an end of each of the guide members1400(e.g., the loop1402) such that the guide members1400are restricted from retracting when the guide member retainer1980is engaged with the lock wire retainer1902. The position where the guide member retainer1980is engaged with the guide members1400is generally at a position between the lock wire retainer1902and the side branch portals110.

In some embodiments, the guide members1400a,1400b,1400cmay implement a coupling system for coupling the guide members1400to the to the guide member retainer1980proximate the second end1204of the elongate member1200, the coupling system including a feature, for example a spherical tip, that is received by a corresponding member of the guide member retainer1980. For example, the guide member retainer1980may receive the spherical tip of the guide members1400through an aperture or through a loop, where the diameter of the spherical tip of the guide members1400is greater than the diameter of the aperture or loop of the guide member retainer1980. Other examples of embodiments for matingly engaging or coupling the guide members1400a,1400b,1400cat an end of the delivery system1000proximate the second end1204of the elongate member1200can be achieved by a variety of coupling arrangements, including press fitting, threads, ball and detent, articulating clips or jaws, hook and loop, and magnetic arrangements. Any number of methods and structures may be implemented for fastening the guide members1400a,1400b,1400cproximate the second end1204of the elongate member1200, and the disclosed embodiments are not to be limiting to the scope of the disclosure. In some embodiments, a plurality of guide member retainers1980may be implemented, each guide member retainer1980being operable to retain a corresponding guide member1400. Thus, each guide member1400may be independently retained and released from engagement proximate the first end1202of the elongate member1200. When the guide members1400are released, the guide members can be removed from the corresponding side branch portal110.

In some embodiments, the guide members1400may be coupled directly to the lock wire retainer1902. The guide member retainer1980and the guide members1400(either directly or indirectly from the lock wire retainer1902) may be selectively released from the lock wire retainer1902. Each of the guide members1400may be selectively retained either collectively or individually.

Now referring toFIG.11C, in various embodiments, the delivery system1000may include a lock wire1900. In such embodiments, the lock wire1900may secure a steering line or lines1850to the catheter assembly. For example, with reference toFIG.11C, delivery system1000comprises an elongate member1200, an implantable device10, at least one steering line1850, and a lock wire1900. The lock wire1900passes from outside of the body of the patient, through the elongate member1200, and exits at a point near a cap1300. In some embodiments, at this point the lock wire1900interacts with the steering lines1850, then reenters the elongate member1200and continues to the cap1300. In some embodiments, the lock wire1900is coupled to a lock wire retainer1902(see alsoFIG.1) that is positioned at the second end1204of the elongate members1200, for example, between the cap1300and the implantable device10. In such a configuration, the lock wire1900releasably couples the steering lines1850to delivery system1000. Any manner in which the lock wire1900may interact with the steering line or lines1850to maintain a releasable coupling between the steering line or lines1850and delivery system1000is within the scope of the present disclosure.

In various embodiments, each steering line may further include an end loop. For example, each steering line1850comprises an end loop. The lock wire1900may pass through each end loop, securing each steering line1850to delivery system1000. Any method of securing the steering line or lines1850to delivery system1000is within the scope of the invention.

In various embodiments, lock wires can be formed from metallic, polymeric or materials and can include conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomeric organosilicon polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol. Elongated members or lock wires can also be formed from high strength polymer fibers such as ultra high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.).

In various embodiments, a catheter assembly used to deliver an expandable implant comprises a catheter shaft, an expandable implant, one or more sleeves, one or more steering lines, and a lock wire. In such configurations, the expandable implant is capable of bending, through tension applied to the one or more steering lines and corresponding displacement, to conform to curvature in the vasculature of a patient. Tension can be applied to the steering lines1850, causing expandable implant implantable device10to bend in a desired manner. For example, implantable device10can bend in a direction aligned with the location of the steering lines1850. Once the implantable device10has been sufficiently bent, consistent tension is applied to steering lines1850to maintain the degree of bending. In other examples, the device10is configured to remain curved following tensioning of the steering lines1850absent a straightening force.

In various embodiments, tension can be applied to the steering lines1850by pulling the lines from the outside of the body of the patient. In other embodiments, the steering lines1850can be connected to one or more dials or other mechanisms for applying the tension at the trailing end of the elongate member1200. In this configuration, the dial can be used to apply a desired tension, as well as maintain the correct amount of tension once a desired angle of bending of implantable device10has been achieved. Various embodiments may also comprise an indicator, scale, gradient, or the like which demonstrates the amount of tension or displacement of the steering line, and/or the amount of bending in implantable device. In various embodiments, the catheter assembly can comprise one more additional markings (e.g., on a handle) that allow a user to determine the orientation of the steering line with respect to the vasculature.

After a sufficient degree of bending has been achieved in the implantable device10, the implant can be rotated for final positioning in the treatment area of the vasculature. In various exemplary embodiments, the lock wire1900is engaged with the steering lines1850such that torsional rotation of the catheter shaft causes the implantable device10to rotate within the vasculature. However, any configuration of the delivery system1000which allows for rotation of implantable device10is within the scope of the present disclosure.

After the implantable device10is in position and expanded within the vasculature, the lock wire1900can be disengaged from delivery system1000. In various embodiments, the lock wire1900is disengaged by applying sufficient tension to the lock wire1900from outside of the body of the patient. After the lock wire1900is disengaged, the steering lines1850can be released from coupling with the elongate member1200and can be removed from implantable device10and delivery system1000.

With further reference toFIG.11A, the guide members1400a,1400b,1400care each extending through a respective side branch portal110of the main body100of the implantable device10. Cannulation of the side branch portals110occurs prior to insertion of the implantable device10into the patient via the access site. Pre-cannulation can shorten the procedure time and simplify the steps performed during the operation, which can reduce trauma to the patient's tissue and damage to the implantable device10. The guide members1400a,1400b,1400cextend through the side branch portals110and through the second opening109of the main body100of the implantable device10. Thus, the guide members1400a,1400b,1400cmay be positioned inside the main lumen102of the implantable device10from the side branch portals110to the second end108of the device. The guide members1400a,1400b,1400cextend from the second opening109and toward the second end1204of the elongate member1200. In some embodiments, the guide members1400a,1400b,1400care routed through the handle1100(seeFIG.1) and in other embodiments, the guide members1400a,1400b,1400care routed through other ports (not shown). The guide members1400a,1400b,1400cmay extend along the outside of the elongate member1200, or the guide members1400a,1400b,1400cmay extend through the elongate member (not shown). In order to reduce tangling or crossing of the guide members1400a,1400b,1400c, wire management devices (not shown) may be implemented. For example, a wire management device may be provided to minimize interaction of each of the plurality of guidewires and/or guide members with each other and other components of the delivery system1000in order to limit or prevent tangling, tying, or interference of the guidewires and/or guide members one with another and other components of the delivery system1000, which obstructs advancement of devices along the guidewires and/or guide members. The wire management device maintains each of the guidewires and/or guide members in predetermined positions. The wire management device is operable to release portions of the guidewires and/or guide members when a device is advanced along the longitudinal length of the wire management device, allowing the device and its branches to be advanced through the lumen of the patient. For example, the delivery system1000may include a wire management device that releasably contains a plurality of guidewires and/or guide members. The wire management device may be configured to release a first portion of the at least one of the guidewires and/or guide members when a device is advanced along the main guidewire1500and configured to release a second portion one of the guidewires and/or guide members when the device is advanced along the main guidewire1500to a second longitudinal position. Thus, the wire management device progressively (described also as step-wise, inch-by-inch, or sequentially) releases the guidewires as a device is advanced with respect to the delivery system1000. This allows the guidewires to be appropriately positioned and to interact with the device (e.g., pass into an internal lumen of the device) in accordance with delivery of the device.

Referring now toFIG.12, the implantable device10can be at least partially deployed. For example, the main body100can be partially deployed from a first, constrained diameter to a second, partially constrained diameter that is larger than the first diameter. As is illustrated inFIG.12, the main body100can also include a first region3000and a second region3002. The first region3000extends from the first end106to the second opening121of the side branch portal110and the second region3002extends from the second opening121of the side branch portal110to the second end108of the main body100. The dividing point between the first and second regions3000,3002may be defined at slightly different positions (e.g., generally within about 3 cm of the side branch portals110). In some embodiments, the first and second regions3000,3002can be independently constrained and/or deployed. For example, as illustrated inFIG.12, the second region3002is partially deployed to the second, partially constrained diameter whereas the first region3000is maintained at the first, constrained diameter. By partially deploying the second region3002, the side branch portals110are operable to at least partially expand. Such constraining members and staged deployment may include, but are not necessarily limited to primary and secondary sleeves of the constraining member1800. The primary and secondary sleeves may be used in series which allows for expansion or partial expansion of a portion of the main body100by releasing one of the primary or secondary sleeves. This permits access through the side branch portals, while still allowing the main body100to be manipulated relative to the target site. Furthermore, by maintaining the first region3000in the first, constrained configuration, access through the second opening121of the side branch portal110is unrestructured or unblocked by the first region3000of the main body100. This also facilitates access to the branched lumens (e.g., brachiocephalic artery24).

Referring now toFIGS.13a-13c, a sheath1600is provided for each guide member1400. For example, when there is a first, second, and third guide member1400a,1400b,1400cfor the first, second, and third side branch portals110a,110b,110c, a first, second, and third sheath1600a,1600b,1600c(seeFIG.15) is provided for each corresponding side branch body200and guide member1400. Each sheath1600is operable to advance along each corresponding guide member1400. The sheath1600can be formed to move along the guide member1400by surrounding the guide member1400, by using the guide member as a rail in a side-by-side orientation, or as would otherwise permit the sheath1600the move substantially along the path of the guide member1400. Because the side branch portals110are already pre-cannulated with the guide members1400a,1400b,1400c, the sheath1600can be advanced through the second opening109of the elongate member and out the second opening121of the side branch portal110. For example, a first end1602of the sheath1600can be advanced through the vasculature of a patient and out the second opening121of the side branch portal110. The first end1602may be positioned proximate the corresponding branch of the vasculature (e.g., the brachiocephalic artery).

In some embodiments, the sheath1600includes a lumen through which an articulatable secondary guide member or catheter1700can be inserted (e.g., the same lumen through which the guide members1400are passed). Various secondary articulatable member or catheter1700may be implemented, including, but not limited to, steerable catheters and guidewires. For example, articulatable secondary member or catheter1700can be steered using at least one tether or tension member (not shown) coupled to a distal end of the articulatable guidewire1700(the articulatable guide member or catheter1700may be an integral unit, or may be a composite of various components for providing the articulating function, e.g., a guide catheter and a guidewire). The articulatable guide member or catheter1700may be steered by applying tension to the tether or tension member. Various degrees of motion can be achieved using multiple tethers and/or tension members. Other embodiments may include robotic or motor-driven guidewires. Various embodiments of an articulatable guidewire may be implemented in the delivery system1000and method. The articulatable secondary guide member or catheter1700is advanced to the treatment site via the sheath1600. For example, as illustrated inFIG.14, a first articulatable secondary guide member or catheter1700ais advanced to the target site via the first sheath1600athrough first side branch portal110a. The articulatable secondary guidewire1700includes a leading end that can be articulated by the user at a trailing end (not shown). The leading end can bend or articulate to various configurations and positions. Once the leading end of the first articulatable secondary guide member or catheter1700ais free from the first sheath1600a, the user is able to articulate the leading end of the first articulatable secondary guide member or catheter1700ainto position in the target branch corresponding to the first side branch portal110a(e.g., the brachiocephalic artery). Once the secondary guide member or catheter1700ais in place, a guidewire1702may be advanced into position (e.g., through the secondary guide member or catheter1700a). This step is repeated for each branch and corresponding side branch portal110with a subsequent articulatable secondary guide member or catheter1700. Referring toFIG.15, the guidewire1702can be advanced through the filter2002that was deployed in the branch. Furthermore, the guidewire1702can be advanced such that the guidewire1702extends out the filter's access site to create a through-and-through configuration of the guidewire1702.FIG.16illustrated each of the branches (e.g., brachiocephalic, left common carotid, and left subclavian arteries24,25,26) being cannulated with corresponding articulatable secondary guidewires1700, where the guidewires1700extend through a corresponding side branch portal110.

Referring now toFIG.17, the first region3000is partially deployed to the second, partially constrained diameter. When the first region3000is partially deployed, the entire main body100is partially deployed to the second, partially constrained diameter. At this stage, the main body100can be adjusted to the appropriate position within the target site to facilitate optimal placement and performance of the implantable device10. Once the desired positioning of the main body100is achieved, the main body100can be deployed to a third, deployed diameter (e.g., not constrained by the constraining member1800). As illustrated inFIG.18, once the main body100is fully deployed, portions of the delivery system1000may be removed, including the elongate member1200and cap1300, the at least one guide member1400, the at least one sheath1600, and the constraining members1800. As previously described, the guide members1400may be released, which may occur at this point in the procedure. In some embodiments, the main guidewire1500may also be removed. This results in the main body100remaining at the target site with secondary, articulatable guidewires1700cannulating corresponding side branch portals110and branches (e.g., brachiocephalic, left common carotid, and left subclavian arteries24,25,26).

Referring toFIG.19, branch bodies200can be advanced along corresponding secondary, articulatable guidewires1700. The branch bodies200can be advanced on independent components, for example, elongate members4000with end caps4002, and so forth, similar to the components used to deliver the main body100. The end caps4002, or other independent components, can dilate the side branch portals110in some embodiments as the branch bodies200are passing through the side branch portals110. The branch bodies200are positioned such that a first portion202is at least partially positioned in the branch of the target site and a second portion is positioned within the implantable device10(e.g., within the side branch portal110). Once the branch bodies200are appropriately positioned, the branch bodies200are deployed, as illustrated inFIG.20. Referring toFIG.21, the elongate members4000and end caps4002used to deliver the branch bodies200are removed.FIG.22illustrates aspiration of the filtration system2000. Once, the filtration system2000is aspirated, the filtration system2000can be removed, as illustrated inFIG.23. The remaining components can be removed from the patient (e.g., the main guidewire1500and the secondary, articulatable guidewires1700) and the surgeon can commence closure.

Referring toFIGS.25-28, in some embodiments, another embodiment of the device10is provided with a plurality of selectable side branch portals510.FIG.25illustrates a side view of an example of an implantable device10having a main body500and a plurality of selectable side branch portals510extending therethrough. The implantable device10also includes the side branches502extending from the main body500through the selectable side branch portal510. The side branches502are separate from the main body500(i.e., they are not integral with the main body500). Because the side branches502are separate structures from the main body500, the side branches502are coupled to the main body500to form the implantable device. For example, the main body500may be deployed in the abdominal aorta and the side branches502may be deployed in the renal arteries and extend into the main body500positioned in the abdominal aorta.

As shown inFIG.26A, in some embodiments the main body500of the implantable device10includes a tubular member520and a stent member540. As shown, the tubular member520has a first end522and a second end524. The tubular member520forms a primary lumen526having a first opening523at the first end522and a second opening525at the second end524of the tubular member520. The tubular member520includes a side branch portal510that includes a column528positioned within the primary lumen526and forms a secondary lumen530(seeFIG.26B). The tubular member520defines an aperture532into the secondary lumen530at a position longitudinally between the first end522and second end524of the tubular member520. The column528defines a column opening534(seeFIG.26B) proximal the second end524of the tubular member520. The stent member540supports the tubular member520in such a manner that the implantable device is operable to be configured in a delivery configuration and in a deployed configuration, or to be transitioned from a delivery configuration toward a deployed configuration.

In some embodiments, the tubular member520includes a first graft member541defining the primary lumen526and a second graft member542coupled to the first graft member541to form the column528defining the secondary lumen530between the first graft member541and the second graft member542. For example, the first graft member541includes graft material formed in the shape of a tube to define the primary lumen526. The second graft member542optionally includes graft material that is coupled to the first graft member541(e.g., via boding, adhesive, or by otherwise being coupled together) to form the secondary lumen530. The graft materials of the first and second graft members541,542may be the same material or different materials as desired. Though some materials may provide certain advantages over others, a variety of suitable graft materials may be implemented, and generally any suitable graft material may be implemented including those materials discussed herein.

In some embodiments the secondary lumen530extends at least partially along a longitudinal length of the main body512. The secondary lumen530of the column528opens into the primary lumen526at the proximal opening of the secondary lumen530. In some embodiments, the column528extends to the second end524of the tubular member520such that the column opening534is positioned at or coplanar with the second opening525of the tubular member520. In other embodiments, the column528extends toward the second end524of the tubular member520such that the column opening534is longitudinally spaced from the second opening525of the tubular member520. In embodiments including a plurality of columns528, the column openings534may be positioned at the same longitudinal length across, or in different terms, at the same longitudinal position along, the tubular member520or they may be staggered at two or more longitudinally-spaced positions along the length of the tubular member520.

In some embodiments, the column528, and consequently the secondary lumen530are collapsible. For example, the column528may be unsupported by a stent member, although supported, collapsible embodiments are also contemplated. Lack of a support, or a suitably configured support, may allow the column528to be collapsed (radially collapsed) to seal the aperture532and limit the leaking or other passing of fluids (e.g., blood) through the aperture532. In some embodiments, the pressure (e.g., hydrostatic pressure, fluid pressure gradients, and/or pressure exerted by fluids in motion) that is exerted by the fluid collapses the column528such that the column coapts or seals against the tubular member520to limit flow through the secondary lumen530and consequently the aperture532.

As illustrated inFIG.26A, the column528may be sealed or closed near the first end522of the tubular member520, or, in some embodiments not shown, at the first end522. The secondary lumen530thus is operable to provide fluid communication between the exterior surface of the tubular member520between the first and second end522,524and the primary lumen526, for example, when the column528is patent. In some embodiments, the tubular member520may include a column528that is unsealed (i.e., includes an opening) near the first end of the tubular member520. In such embodiments, an elongate member such as a delivery catheter may be positioned through the column528. Referring toFIG.26B, an end view of the main body512is shown with the column opening534positioned proximate the second end524of the main body512. In some embodiments, columns528extend to the second end524of the main body512. As illustrated, the secondary lumen530may be contained within the primary lumen526.

Referring again toFIG.26A, the main body512includes the stent member540. The stent member540may be formed of any suitable material as is discussed hereafter. The stent member540is operable to support the tubular member520. The stent member540may be compressed into a delivery configuration and may be expanded into an expanded configuration, such as at deployment. The stent member540may be a self-expanding stent or a balloon expandable stent. As illustrated, the stent member540includes a plurality of stent rings544. Each stent ring544circumferentially supports the tubular member520at a longitudinal position along the length of the tubular member520. For example, each stent ring544is longitudinally spaced from an adjacent stent ring544. The stent rings544may each include apices546with first apices546apointing toward the first end522and second apices546bpointing toward the second end524. Various other configurations of stent members40are contemplated herein including, but not limited to, helical stents (including undulating helical stents, diamond pattern stents, and others).

As illustrated inFIG.26A, the tubular member520includes a plurality of apertures532spaced along the longitudinal length of the main body512. The apertures532may be positioned such that at least one stent ring is between the two longitudinally adjacent apertures532. For example, a column528may include apertures532through the tubular member520such that the apertures532are longitudinally spaced along the main body512. The apertures are all in fluid communication with the secondary lumen530of the column528. The apertures532provide access points for the secondary branch at various longitudinal lengths along the main body512.

Referring toFIG.26C, the apertures532may be formed in a variety of shapes and size including circular profiles, a profile with a rounded edge and a substantially flat edge, ovular profiles, and so forth. The various shapes and sizes may be implemented to accommodate various side branches502and configurations such as angle of exit of the side branches502from the main body512at the apertures532. In some embodiments not shown, the apertures532may be irregularly spaced along the longitudinal length of the column528. Furthermore, in some embodiments not shown, the apertures532may be circumferentially spaced within a column528. For example, the apertures532may be staggered circumferentially and/or longitudinally.

In some embodiments, the main body512may include a plurality of columns528. For instance, the main body512may include two columns528that are circumferentially spaced from each other in order to deploy two side branches514into the side branch lumens of the patient's anatomy. Furthermore, the main body512may include a plurality of columns528that are associated with each side branch lumen of the patient's anatomy. For example, if the main body512is to be deployed in the abdominal aorta and the side branches514are to be deployed into the renal arteries, each patient may have a various positions circumferentially at which the renal arteries enter the aorta.

By having a plurality of columns528through which each side branch514may be deployed, the surgeon may select the appropriate columns528that best conform to the patient's native anatomy without applying torsion to the vessels when the implantable device10is deployed. Thus, in one example, the main body512may include three columns528on one circumferential side of the tubular member520and three more columns528on an opposite circumferential side of the tubular member520. Each column528is circumferentially spaced from the adjacent column528about the circumference of the tubular member520. It is contemplated that any number of columns528and the spacing of the columns528may be implemented, including one, two, three, four, five, six, seven, eight, or more columns528which may be spaced equally or variably about the circumference of the tubular member520. It is further contemplated that the specific spacing may be determined by surveying the average circumferential spacing of side branches for a particular implementation in a sample population of patients to determine the spacing of the columns528. Circumferential spacing of the column528allows for clocking of the main body512within the patient's anatomy with increased positions for appropriately positioning the side branches514into the side branch vessels. As used herein, the term “clocking” refers to the ability to position features at a desired location about a circumference of an object. This ability to clock the one or more columns528can be further advantageous for use with visualization, for example when the procedure is being performed via fluoroscopy. This simplifies placement by providing several entry points when dealing with the two-dimensional planes shown by visualization techniques and for parallax associated with such visualization. In some embodiments, the columns528may be irregularly spaced about the circumference of the main body512(e.g., non-uniform spacing between the columns528). In some embodiments not shown, the column528extends longitudinally and at angle greater than zero relative to the main body512longitudinal axis. For example, the secondary lumen530extends along a secondary lumen axis that extends longitudinally at an angle greater than zero relative to an axis of the primary lumen526(e.g., helically about the main body512).

Referring again toFIG.26A, the main body512may include a constraining member receiver50positioned surrounding at least a portion of the stent member40. For example, in those embodiments including a plurality of stent rings544, a corresponding constraining member receiver550is positioned about each stent ring544. The constraining member receiver550may be formed from a variety of materials including graft materials, fibers, and so forth. The constraining member receiver550is operable to receive constraining members that can be retracted to partially constrain or collapse the stent rings544as is discussed hereafter.

In some embodiments, the tubular member520may include a scallop552at the first end522. The scallop552is a facilitates placement of the tubular member520in a lumen including a side branch lumen that does not need a prosthetic side branch deployed. For example, when the implantable device10is positioned in the abdominal aorta and the superior mesenteric artery does not need a side branch514deployed therein, the scallop552may be positioned over the entrance into the superior mesenteric artery without blocking or restricting blood perfusion therethrough. The scallop552may include various shapes including straight edge profiles, curved profiles, and combinations thereof.

Referring now toFIGS.27A-27C, a catheter olive or cap1300is positioned at the first end of the elongate member1200such that the main body512of the implantable device10is positioned longitudinally between the cap1300and the second end of the elongate member1200. Although an embodiment of the cap1300is depicted in the drawings, it is in the scope of the disclosure that any catheter olive or cap may be implemented within the scope of this disclosure. The cap1300may be implement to atraumatically advance the delivery system1000through the patient and to dilate the surrounding anatomy where appropriate. For example, the cap1300may include a leading tip which is advanced first through the patient's anatomy. Referring toFIGS.27A-27C, the cap1300may include a guide member retainer1302. However, the guide member retainer1302may comprise a passage through which the guide members1400pass (seeFIG.27A). In this embodiment, the guide members1400may pass through the cap1300and extend back through an aperture532of another, oppositely positioned column528. The guide member retainer1302may be operable to releasably retain a lock wire1900to which the guide members1400may be coupled (seeFIG.27B). The lock wire1900may be controlled via the lock wire lumen. The guide member retainer may be operable to received and releasably retain ends of the guide members1400, for example via a friction fit or other coupling (seeFIG.27C). Various embodiments of caps1300may be implemented specifically for coupling the guide members1400(e.g., the guide member retainers1302). Such embodiments include those discussed in U.S. Pat. Pub. No. 2020/0046534 by Chung et al., filed Aug. 13, 2019, the content of which is hereby expressly incorporated by reference. In some embodiments, the cap1300may be curved to facilitate clocking of the device10as it is advanced to the target site from implantation.

Although the method was disclosed with reference to the aorta20, the systems and method described herein could be implemented on various lumens where branching occurs.

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

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

It is understood that any of the components of the systems can also include radiopaque markers to facilitate viewing on an x-ray fluoroscope during an implantation procedure. Any number, shape and location of radiopaque markers can be utilized as needed.

Delivery systems and methods disclosed herein are particularly suited for endoluminal delivery of branchable expandable implants for treating branched vasculature. Expandable implants can include, for example, stents, grafts, and stent grafts. Further, expandable implants can include one or more stent components with one or more graft members disposed over and/or under the stent, which can dilate from a delivery configuration, through a range of larger intermediary configurations, and toward a deployed configuration engaged with vessel walls at a treatment site. However, and as discussed below, any suitable combination and configuration of stent component(s) and graft member(s) is within the scope of the present disclosure. For example, stent components can have various configurations such as, for example, rings, cut tubes, wound wires (or ribbons) or flat patterned sheets rolled into a tubular form. Stent components can be formed from metallic, polymeric or natural materials and can comprise conventional medical grade materials such as nylon, polyacrylamide, polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride, polyurethane, elastomeric organosilicon polymers; metals such as stainless steels, cobalt-chromium alloys and nitinol and biologically derived materials such as bovine arteries/veins, pericardium and collagen. Stent components can also comprise bioresorbable materials such as poly(amino acids), poly(anhydrides), poly(caprolactones), poly(lactic/glycolic acid) polymers, poly(hydroxybutyrates) and poly(orthoesters).

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

In addition, 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. Other materials may also be used as appropriate, including but not limited to NiTiCo.

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

Any of a variety of bio-active agents may be implemented with any of the foregoing. For example, any one or more of (including portions thereof) the implantable device10and the delivery system1000may comprise a bio-active agent. Bio-active agents can be coated onto one or more of the foregoing features for controlled release of the agents. Such bio-active agents can include, but are not limited to, thrombogenic agents such as, but not limited to, heparin. Bio-active agents can also include, but are not limited to agents such as anti-proliferative/antimitotic agents including natural products such as vinca alkaloids (e.g., vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (e.g., etoposide and teniposide), antibiotics (e.g., dactinomycin (actinomycin D), daunorubicin, doxorubicin, and idarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes (e.g., L-asparaginase which systemically metabolizes L-asparagine and deprives cells which do not have the capacity to synthesize their own asparagine); antiplatelet agents such as G(GP) IIb/IIIa inhibitors and vitronectin receptor antagonists; anti-proliferative/antimitotic alkylating agents such as nitrogen mustards (e.g., mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (e.g., hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan, nitrosoureas (e.g., carmustine (BCNU) and analogs, streptozocin), trazenes-dacarbazinine (DTIC); anti-proliferative/antimitotic antimetabolites such as folic acid analogs (e.g., methotrexate), pyrimidine analogs (e.g., fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (e.g., mercaptopurine, thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes (e.g., cisplatin and carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide; hormones (e.g., estrogen); anti-coagulants (e.g., heparin, synthetic heparin salts and other inhibitors of thrombin); anti-platelet agents (e.g., aspirin, clopidogrel, prasugrel, and ticagrelor); vasodilators (e.g., heparin, aspirin); fibrinolytic agents (e.g., plasminogen activator, streptokinase, and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory agents; antisecretory agents (e.g., breveldin); anti-inflammatory agents, such as adrenocortical steroids (e.g., cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agents (e.g., salicylic acid derivatives, such as aspirin); para-aminophenol derivatives (e.g., acetaminophen); indole and indene acetic acids (e.g., indomethacin, sulindac, and etodalac), heteroaryl acetic acids (e.g., tolmetin, diclofenac, and ketorolac), arylpropionic acids (e.g., ibuprofen and derivatives), anthranilic acids (e.g., mefenamic acid and meclofenamic acid), enolic acids (e.g., piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, gold compounds (e.g., auranofin, aurothioglucose, and gold sodium thiomalate); immunosuppressives (e.g., cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, and mycophenolate mofetil); angiogenic agents (e.g., vascular endothelial growth factor (VEGF)), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; anti-sense oligonucleotides and combinations thereof; cell cycle inhibitors, mTOR inhibitors, growth factor receptor signal transduction kinase inhibitors; retinoids; cyclin/CDK inhibitors; HMG co-enzyme reductase inhibitors (statins); and protease inhibitors. Delivery systems and methods in accordance with various embodiments disclosed herein can utilize removable guidewires to preserve branch portals for guidewire cannulation therethrough subsequent to compacting the expandable implant toward a delivery configuration for endoluminal delivery to the treatment site. Removable guidewire tube can comprise the same materials listed above for the catheter materials.

Numerous characteristics and advantages of the present invention have been set forth in the preceding description, including preferred and alternate embodiments together with details of the structure and function of the invention. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications may be made, especially in matters of structure, materials, elements, components, shape, size and arrangement of parts within the principals of the invention, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein. In addition to being directed to the embodiments described above and claimed below, the present invention is further directed to embodiments having different combinations of the features described above and claimed below.

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