Ascending aortic stent graft

Abstract

An implantable medical device including a frame operable to transition between a delivery configuration and a deployed configuration, a tubular member supported by the frame and defining a side wall, wherein the tubular member defines a lumen extending therethrough and at least one fenestration defined by the side wall, and a valve supported by the frame and positioned upstream from the at least one fenestration when implanted in an ascending aorta.

Description

ASCENDING AORTIC STENT GRAFTCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63 / 647,419, filed May 14, 2024, which is incorporated herein by reference in its entirety for all purposes.FIELD

[0002] The present disclosure relates generally to apparatuses, systems, and methods stent grafts for implantation in the ascending aorta. More specifically, the present disclosure relates to stent grafts isolating pathology of the ascending aorta while for providing a temporary prosthetic aortic valve and fenestrations maintaining perfusion to the coronary arteries.BACKGROUND

[0003] Aneurysms and dissections occur in blood vessels at sites where, due to age, disease or genetic predisposition of the patient, the strength or resilience of the vessel wall is insufficient to prevent ballooning or stretching of the wall as blood passes through. If the aneurysm is left untreated, the blood vessel wall may expand and rupture, often resulting in death.

[0004] 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.

[0005] In particular, aneurysms in the ascending aorta typically involve tissue right up to a frequently past the sinotubular junction on the proximal end of the ascending aorta. This position of an aneurysm includes several features that make treatment difficult including the position of the coronary ostia and the aortic valve.SUMMARY

[0006] Stent grafts and methods for implantation in the ascending aorta are provided herein. More specifically, the present disclosure relates to stent grafts for providing a temporary prosthetic aortic valve and maintaining perfusion to the coronary arteries.

[0007] According to one example (“Example 1”), an implantable medical device includes a frame operable to transition between a delivery configuration and a deployed configuration; a tubular member supported by the frame and defining a side wall, wherein the tubular member defines a main lumen extending therethrough and at least one fenestration defined by the side wall; at least one branch member positioned within the main lumen of the tubular member, each branch member of the at least one branch member being coupled to the side wall to define a sealing with the fenestration such each fenestration is in fluid communication with the main lumen via a corresponding branch member; and a valve supported by the frame and positioned within the main lumen upstream from the at least one fenestration and operable to control fluid transport through the lumen when implanted in an ascending aorta.

[0008] According to another example (“Example 2”), further to Example 1 , wherein the valve includes at least one leaflet configured to allow antegrade blood flow and resist retrograde blood flow.

[0009] According to another example (“Example 3”), further to Example 2, wherein the at least one leaflet is an extension of the tubular member such that the extension is indirectly supported by the frame.

[0010] According to another example (“Example 4”), further to Example 3, wherein the extension is an inverted portion of the tubular member.

[0011] According to another example (“Example 5”), further to Example 4, wherein the extension is selectively bonded to an inner surface of the side wall to define commissures of the at least one leaflet.

[0012] According to another example (“Example 6”), further to Example 1 , wherein the at least one branch member defines a branch lumen between a first end and a second end, wherein each second end of each of the at least one branch member is coupled to the side wall at the corresponding fenestration.

[0013] According to another example (“Example 7”), further to Example 6, wherein each second end of each of the at least one branch member is coupled to the side wall proximate a corresponding fenestration of each of the at least one fenestration such that each branch lumen is in fluid communication with the correspondingfenestration of each of the at least one fenestration.

[0014] According to another example (“Example 8”), further to Example 7, at least one branch lumen is positioned in a retrograde orientation.

[0015] According to another example (“Example 9”), further to Example 7, at least one branch lumen is positioned in an antegrade orientation.

[0016] According to another example (“Example 10”), further to Example 1 , wherein the at least one fenestration is configured to receive a corresponding stent graft, the corresponding stent graft configured to perfuse at least one side branch vessel.

[0017] According to another example (“Example 11”), further to Example 1 , wherein the frame and tubular member define a first end and a second end, wherein the first end includes an engagement portion configured to be positioned across a native aortic valve.

[0018] According to another example (“Example 12”), further to Example 11 , wherein the engagement portion includes retention members operable to engage leaflets of a native aortic valve to limit migration of the leaflets toward a heart of the patient.

[0019] According to another example (“Example 13”), further to Example 11 , wherein the first end is configured to be positioned upstream from coronary ostia and the second end is configured to be positioned within an ascending aorta downstream from the coronary ostia.

[0020] According to another example (“Example 14”), further to Example 11 , wherein the side walls are configured to receive a secondary implantable prosthetic valve such that the valve is disabled when the secondary implantable prosthetic valve is received.

[0021] According to another example (“Example 15”), further to Example 10, wherein at least one leaflet of the valve is configured to be positioned against the side wall when the secondary implantable prosthetic valve is received so as to maintain fluid communication through the at least one fenestration.

[0022] According to another example (“Example 16”), further to Example 1 , wherein the frame is tapered to have a diameter that is smaller at a first end than a diameter at a second end.

[0023] According to another example (“Example 17”), further to Example 1 , wherein the valve includes a plurality of leaflets defining commissures, wherein eachfenestration of the at least one fenestration aligns with a corresponding commissure of the commissures.

[0024] According to another example (“Example 18”), an implantable medical device includes a frame operable to expand from a delivery configuration to a deployed configuration, the frame defining a first end, a second end, and an intermediate portion; a tubular member supported by the frame and defining a side wall, wherein the tubular member includes a first end portion and second end portions, the tubular member defining a main lumen extending therethrough and at least one fenestration defined by the side wall proximate the intermediate portion of the frame, the first end portion being inverted into the main lumen and defining a valve at a first end of the frame.

[0025] According to another example (“Example 19”), a method of deploying an implantable medical device, includes advancing, transvascularly, the implantable medical device to an ascending aorta, the implantable medical device including a frame operable to expand from a delivery configuration to a deployed configuration, a tubular member supported by the frame and defining a side wall, wherein the tubular member defines a main lumen extending therethrough and at least one fenestration defined by the side wall, the tubular member including at least one branch member positioned within the main lumen, each branch member of the at least one branch member being coupled to the side wall to define a sealing with the fenestration such each fenestration is in fluid communication with the main lumen via a corresponding branch member, and a valve supported by the frame and positioned within the main lumen upstream from the at least one fenestration and operable to control fluid transport through the lumen when implanted; and deploying the implantable medical device in the ascending aorta such that a portion of the implantable medical device is positioned in an aortic annulus and the at least one fenestration is positioned proximate a corresponding coronary artery.

[0026] According to another example (“Example 20”), further to Example 19, further includes advancing at least one side branch stent graft to the implantable medical device; and deploying each of the at least one side branch stent graft in a corresponding fenestration of the at least one fenestration and the corresponding coronary artery.

[0027] According to another example (“Example 21”), further to Example 20, further comprising advancing a secondary implantable prosthetic valve to the implantable medical device.

[0028] According to another example (“Example 22”), further to Example 21 , further comprising deploying the secondary implantable prosthetic valve proximate thevalve of the implantable medical device.

[0029] According to another example (“Example 23”), further to Example 22, wherein deploying the secondary implantable prosthetic valve disables the valve of the implantable medical device.

[0030] According to another example (“Example 24”), further to Example 23, wherein deploying the secondary implantable prosthetic valve sandwiches leaflets of the valve of the implantable medical device between the side wall of the implantable medical device and the secondary implantable prosthetic valve such that the at least one fenestration is not covered by the leaflets of the valve of the implantable medical device and is not covered by the secondary implantable prosthetic valve.

[0031] The foregoing Examples are just that, and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature.BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure.

[0033] FIG. 1 is an ascending aneurysm, in accordance with an embodiment; and

[0034] FIG. 2 is an illustration of an implantable medical device for implantation in the ascending aorta, in accordance with an embodiment;

[0035] FIG. 3 is an illustration of an implantable medical device with antegrade branch members, in accordance with an embodiment;

[0036] FIG. 4 is an illustration of an implantable medical device with retrograde branch members, in accordance with an embodiment;

[0037] FIG. 5 is an illustration of an implantable medical device with ends having different diameters, in accordance with an embodiment;

[0038] FIGS. 6A-6C are illustrations of end views of implantable medical devices illustrating alignment of fenestrations with commissures, in accordance with an embodiment;

[0039] FIG. 7 is an illustration of an implantable medical device with sidebranches deployed through the fenestrations and branch members, in accordance with an embodiment;

[0040] FIG. 8 is an illustration of an implantable medical device with a secondary implantable prosthetic valve positioned therein, in accordance with an embodiment.DETAILED DESCRIPTIONDefinitions and Terminology

[0041] 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.

[0042] With respect to terminology of inexactitude, the terms “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error, differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, minor adjustments made to optimize performance and / or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and / or manipulation of objects by a person or machine, and / or the like, for example. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms “about” and “approximately” can be understood to mean plus or minus 10% of the stated value.Description of Various Embodiments

[0043] Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

[0044] The device shown in FIG. 2 is provided as an example of the various features of the device and, although the combination of those illustrated features isclearly within the scope of invention, that example and its illustration is not meant to suggest the inventive concepts provided herein are limited from fewer features, additional features, or alternative features to one or more of those features shown in other figures. It is understood that the various features shown in the drawings may be implemented with each other. For example, FIG. 7 illustrates side branches positioned through the fenestrations and in the branch members. It is understood that the side branches could be implemented with respect to the embodiment of FIG. 2 which does not include branch members. Thus, various features shown and described with respect to the various embodiments are understood to be implemented with respect to the other various embodiments, as appropriate.

[0045] Referring to FIG. 1 , an example of a portion of an aorta 10, aortic root 14, and left ventricular outflow tract 24 are illustrated for background purposes. The aorta 10 extends from the aortic root 14, which includes the sinotubular junction 16, the aortic valve 12, and the coronary ostia 22. Coronary arteries 20 extend from the aortic root 14 at the coronary ostia 22. The aorta 10 of FIG. 1 includes a dissection. The aneurysm is shown both prior to and after rupture.

[0046] FIGS. 2A and 2B illustrate an implantable medical device 100 for bypassing the pathology in the aorta 10 (FIG. 1). The implantable medical device 100 is configured to be deployed across the aortic valve 12 and the coronary ostia 22. The implantable medical device 100 includes a frame 102 (e.g., a stent) and a tubular member 104 (e.g., a graft material). The frame 102 is operable to expand or transition from a delivery configuration to a deployed configuration. The frame 102 may be either self-expanding or may be expandable (e.g., balloon expandable). The tubular member 104 is supported by the frame 102. The tubular member 104 defines a side wall 106 on the interior of the tubular member 104. The tubular member 104 also includes a main lumen 108 extending therethrough. The tubular member 104 may also include at least one fenestration 110 defined by the side wall 106. Each fenestration 110 is configured to perfuse one of the coronary arteries 20 and is discussed in more detail hereafter. The implantable medical device 100 further includes a valve 112 supported by the frame 102 and positioned within the main lumen 108 upstream from the fenestration 110 and operable to control fluid transport through the main lumen 108 when the implantable medical device 100 is implanted in the aorta 10. The valve 112 may be a temporary or a permanent valve.

[0047] In some embodiments, the valve 112 includes at least one leaflet 114 configured to allow antegrade blood flow through the implantable medical device 100and limit or resist retrograde blood flow through the implantable medical device 100. The valve 112 and leaflet 114 may be provided in various configurations, including but not limited to, mono-leaflet valves, bi-leaflet valves, tri-leaflet valves, or any number of leaflets. The leaflets 114 may be provided in various shapes and configurations, including those mimicking anatomic leaflets and those that do not mimic anatomic leaflets. For example, the leaflets 114 may be provided to substantially mimic the shape and operation of any of the native heart valves, including the aortic valve, or may be provided otherwise. The leaflets 114 are provided and configured to be spaced from the fenestrations 110 when in an open configuration and a closed configuration such that the leaflets 114 do not limit blood through the fenestrations 110. Furthermore, the leaflets 114 are spaced from the fenestrations such that when a secondary implantable prosthetic valve 200 (see FIG. 8) is received and implanted in the main lumen 108, the leaflets 114 are disabled and rest against the side wall 106 such that the leaflets 114 do not obstruct or limit blood flow through the fenestrations 110.

[0048] In some embodiments, the leaflets 114 are an extension of the tubular member 104. For example, the implantable medical device 100 is constructed such that the tubular member 104 is longer than the frame 102 and includes a first end portion and a second end portion, where the first end portion includes the extension portion 114a of the tubular member 104 (See FIG. 2A). The tubular member 104 is positioned with the frame 102 such that a portion of the tubular member 104 is directly supported by the frame 102 (e.g., the length of the tubular member 104 coupled to the frame 102 from a first end of the frame through an intermediate portion of the frame and to the second end of the frame) and a portion (e.g., the extension portion 114a) is indirectly supported by the frame 102 (e.g., the length of the tubular member 104 that extends beyond either the first or second end of the frame 102). That is, the extension portion 114a that is unsupported directly by the frame 102 may be used to form the leaflets 114. For example, the extension portion 114a may be inverted at least partially into the main lumen 108 at a fold line FL and portions of the extension portion 114a may be coupled (e.g., sewn, selectively bonded, adhered, etc.) to the side wall 106 (e.g., the inner surface of the side wall or the lumen wall) to define the leaflet 114. As previously discussed, the leaflets 114 may be provided in various forms and configurations including mono-leaflet, bi-leaflet, and tri-leaflet valves. The leaflets 114 are coupled to the side wall 106 to define commissures 115 between the leaflets. Depending on the number of leaflets 114 (e.g., two, three, or more leaflets), there may be various numbers of commissures between the leaflets 114. The commissures 115, for example, in a tri-leaflet configuration may be spaced at about 120 degrees from each other. In a bileaflet configuration, the commissures 115 may be spaced at about 180 degrees from each other. In some embodiments, the commissures 115 may be spaced so as to approximately correlate to the location of the coronary arteries.

[0049] In some embodiments, the leaflets 114 may be separate from the tubular member 104 (e.g., not an extension of the tubular member 104) and may be coupled to the tubular member 104 and / or the frame 102. The leaflets 114 may be formed of various materials, including, but not limited to polymeric and biological material. For example, the leaflets 114 may be formed of various materials, including but not limited to fluorinated polymers such as polytetrafluoroethylene (PTFE) and fluorinated ethylene propylene (FEP), polyethylene (PE), polyester, a silicone, a urethane, a polyethylene terephthalate, or another biocompatible polymer, or combinations thereof, including expanded versions thereof (e.g., expanded PTFE and expanded PE).

[0050] In some embodiments, the leaflets 114 include a porous material such that the leaflets are configured for cellular ingrowth and incorporation. The porous nature of the leaflets may reduce the likelihood of thrombus formation and embolization in long term use. In some embodiments, the leaflets 114 are provided as a temporary valve for implantation (e.g., the valve 112 being used for a short duration such as hours, days, or weeks) until the valve 112 is disabled by implantation of a secondary implantable prosthetic valve 200. The secondary implantable prosthetic device can be implanted at the position of the leaflets 114, thus constraining or pinning the leaflets 114 to the side wall 106. As the leaflets 114 are disabled and positioned against the side wall 106, the leaflets 114 are inoperable.

[0051] Referring now to the fenestration 110, the fenestration 110 is provided to facilitate perfusion of side branches that extend from the aorta 10. For example, when the implantable medical device 100 is implanted in the aorta 10, the tubular member 104 may cover the coronary ostia 22. In order to perfuse the coronary arteries 20, the fenestrations 110 are positioned proximate the intermediate portion of the frame 102 and / or proximate the coronary ostia 22 when implanted such that blood can flow from the main lumen 108 through the fenestrations 110 and into the coronary arteries 20. As previously discussed, the leaflets 114 are provided such that the leaflets 114 do not cover the fenestrations 110 when the leaflets are positioned against the side wall 106 after implantation of the secondary implantable prosthetic valve 200.

[0052] Referring to FIGS. 6A-6C, the fenestrations 110 may be provided such that they substantially align with at least some of the commissures 115 of the leaflets114. For example, the fenestrations 110 may be provided distally of the commissures 115 and aligned circumferentially with the commissures 115. More specifically, in some examples, a tri-leaflet configuration is provided such that the commissures 115 are spaced circumferentially about 120 degrees from each other (see FIG. 6A). The fenestrations 110 (e.g., a first fenestration and a second fenestration) may be spaced circumferentially from each other at about 120 degrees and clocked such that the fenestrations 110 substantially align circumferentially with the leaflets 114. In bi-leaflet valves, the commissures 115 may be provided at about 180 degrees from each other and the fenestrations 110 provided at about 180 degrees from each other and substantially circumferentially aligned with each of the corresponding commissures 115 (see FIG. 6C). It is understood that the fenestrations 110 may be provided from about zero degrees to about five degrees off-center with a corresponding commissure 115 or may be provided from about five degrees to about ten degrees off-center with a corresponding commissure 115 (see FIG. 6B).

[0053] Referring to FIGS. 3-5, in some embodiments, the implantable medical device 100 includes at least one branch member 120 positioned within the main lumen 108 of the tubular member 104. The implantable medical device 100 may include a branch member for each fenestration 110, wherein the branch member 120 is a branch member 120 that is in fluid communication with the corresponding fenestration 110. Stated otherwise each branch member 120 is coupled to the side wall 106 at the corresponding fenestration 110 to define a sealing with the fenestration 110 such each fenestration 110 is in fluid communication with the main lumen 108 via a corresponding branch member 120. Each branch member 120 defines a branch lumen 122 between a first end 124 and a second end 126. The second end 126 is coupled in a sealing engagement to the side wall 106 proximate the corresponding fenestration 110. This allows fluid (e.g., blood) to flow through the main lumen 108, branch member 120, and through the corresponding fenestration 110.

[0054] In some embodiments, each of the branch members 120 includes a side branch stent structure (not shown) and a side branch graft member (not shown). In various embodiments, the side branch stent structure and side branch graft member can be independent from, incorporated into, or integral with the frame 102 and / or the tubular member 104. For example, the side branch stent structure is separate or independent from the frame 102, whereas the side branch graft member is incorporated into the tubular member 104 (e.g., sandwiched or interposed between layers of the tubular member 104). In some embodiments, the side branch stent structure extendsfrom the frame 102 and therefore represents a portion of the frame 102 rather than an independent stent structure. In still other embodiments, the side branch stent structure is coupled to the frame 102. Similarly, the side branch graft member can be formed directly from the tubular member 104 and therefore represent a portion of the tubular member 104. In other embodiments, the side branch graft member is coupled to the tubular member 104. It is understood that any combination of side branch stent structures and side branch graft member embodiments is within the scope of this disclosure.

[0055] In some embodiments, the branch member 120 is positioned between the ends of the tubular member 104 and does not extend beyond or increase the outer profile of the implantable medical device 100. Stated otherwise, the portion of an outer wall of the branch member 120 is positioned along the side wall 106 within the outer profile of the implantable medical device 100 (e.g., flush with the outer profile). Thus, the branch member 120 may extend into or be positioned within the main lumen 108 of the implantable medical device 100 without substantially increasing the outer profile of the implantable medical device 100 adjacent the exit location of the branch member 120 from the implantable medical device 100.

[0056] For each branch member 120, the first end 124 and second end 126 define a first opening and a second opening, respectively. Fluids travel through the branch member from the first end 124 to the second end 126 defining a side branch fluid flow direction. The branch member 120 is positioned such that the first opening is positioned within or oriented toward the main lumen 108 of the implantable medical device 100 and the second opening is positioned exterior to or oriented away from the implantable medical device 100 (e.g., the first opening is the interior opening and the second opening is the exterior opening of the branch member 120 relative to the side wall 106 and main lumen 108 of the implantable medical device 100). For example, FIG. 5 illustrates those embodiments in which the first opening of the branch member 120 is positioned within the main lumen 108. The branch member 120 may have various longitudinal lengths. Furthermore, when a plurality of branch members 120 are implemented, one or more branch members 120 may have a different length than another of the branch members 120 or one or more of the branch members 120 may have the same length as another of the branch members 120. In embodiments implementing a plurality of branch members 120, each branch member 120 may have a unique diameter and / or geometric orifice area (see FIG. 10) relative to the other branch members 120.

[0057] Referring to FIG. 4, in some embodiments, the branch member 120 is oriented such that the side branch fluid flow direction is opposite to the main body fluid flow direction or direction of flow through the main lumen 108 (e.g., retrograde to the main body fluid flow direction for a retrograde orientation). 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 implantable medical device 100 as the main body may conform to a curved anatomy. Stated otherwise, antegrade flow is in the direction away from the valve 112 (or away from the proximal end of the implantable medical device 100) and retrograde is toward the valve 112 (or toward the proximal end of the implantable medical device 100). By orienting the branch member 120 in 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). This orientation may be advantageous in some presentations where access may difficult, obstructed, or dangerous from certain access sites. It is also understood that the branch member 120 may be positioned substantially parallel to a longitudinal axis of the implantable medical device 100 or at an angle to the longitudinal axis in order to facilitate cannulation or accommodate anatomical differences. Additionally, retrograde configurations facilitate placement of the fenestrations 110 closer to the valve 112 without the branch member 120 interfering with operation of the valve 112 as compared to antegrade configurations.

[0058] Referring to FIG. 3, in other embodiments, the branch member 120 is 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 an antegrade orientation). Antegrade orientations may be advantageous in some embodiments to maintain more traditional fluid flow (e.g., fluid flow in native anatomy), 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 branch members 120, the branch member 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.

[0059] Referring to FIG. 7, in some embodiments, the fenestrations 110 and optionally branch members 120 are configured to receive a corresponding side branch stent graft 150 therethrough, the corresponding stent graft configured to perfuse at leastone side branch vessel (e.g., the coronary arteries 20). Any number of stent grafts may be implanted including self-expanding and / or expandable. In some embodiments, the side branch stent graft 150 is delivered separately from the implantable medical device 100 and is configured to provide fluid coupling between the aorta and side branches.

[0060] Referring to FIG. 8, in some embodiments, the implantable medical device 100 may include or be implemented in conjunction with a secondary implantable prosthetic valve 200. The valve 112 of the implantable medical device 100 is intended to provide a temporary solution until a more permanent replacement valve (e.g., the secondary implantable prosthetic valve 200) can be implanted. The valve 112 may be operable for hours to days until the secondary implantable prosthetic valve 200 200 is implanted. When the secondary implantable prosthetic valve 200 is implanted, the valve 112 becomes non-operational. For example, the leaflets 114 are positioned against the side wall 106 (e.g., sandwiched between the secondary implantable prosthetic valve 200 200 and the side wall 106) when the secondary implantable prosthetic valve 200 is implanted. Stated otherwise, the side walls 106 are configured to receive a secondary implantable prosthetic valve 200 such that the valve 112 is disabled when the secondary implantable prosthetic valve 200 is received. The secondary implantable prosthetic valve 200 may be selected from any number of valves including any transcatheter aortic valve replacement.

[0061] In some embodiments, the frame 102 and tubular member 104 define a first end portion 101 and a second end portion 103, wherein the first end portion101 includes an engagement portion 105 configured to be positioned across a native aortic valve (see FIG. 8). This engagement portion 105 is configured to be placed within the annulus and thus disables the native aortic valve. The engagement portion 105 may include retention members (not shown) to ensure that the implantable medical device 100 is retained in the appropriate position and engages the native aortic valve. The engagement portion 105 is also where the secondary implantable prosthetic valve 200 may be positioned such that the exterior of the engagement portion 105 is in contact with the native aortic valve and the interior of the engagement portion 105 receives the secondary implantable prosthetic valve 200. The valve 112 may also be positioned in the interior of the engagement portion 105. Referring to FIG. 5, in some embodiments, the implantable medical device 100 is tapered to have a diameter that is smaller at a first end portion 101 than a diameter at a second end portion 103. In some embodiments, the first end portion 101 is configured to be positioned upstream from coronary ostia 22 and the second end portion 103 is configured to be positioned withinan ascending aorta 18 downstream from the coronary ostia 22.

[0062] Referring to a method of deployment, the method includes advancing, transvascularly, the implantable medical device 100 to the ascending aorta 18 and deploying the implantable medical device 100 in the ascending aorta 18 such that a portion of the implantable medical device 100 is positioned in the aortic annulus and the fenestrations 110 are positioned proximate corresponding coronary arteries 20.

[0063] The method may further include advancing at least one side branch stent graft 150 to the implantable medical device 100 and deploying each side branch stent graft 150 in a corresponding fenestration 110 and the corresponding coronary artery 20.

[0064] The method may further include advancing the secondary implantable prosthetic valve 200 to the implantable medical device 100 and deploying the secondary implantable prosthetic valve 200 proximate the valve 112 of the implantable medical device 100. Deploying the secondary implantable prosthetic valve 200 disables the valve 112 of the implantable medical device 100. Furthermore, deploying the secondary implantable prosthetic valve 200 sandwiches leaflets 114 of the valve 112 of the implantable medical device 100 between the side wall 106 of the implantable medical device 100 and the secondary implantable prosthetic valve 200 such that the fenestration 110 is not covered by the leaflets 114 of the valve 112 of the implantable medical device 100 and is not covered by the secondary implantable prosthetic valve 200.

[0065] It is understood that other components may be used in combination with those described herein. For example, in some embodiments, an additional stent graft may be used in combination with those described herein. For example, an additional stent graft may be implemented in connection with those described herein for treating the aortic arch and / or the descending aorta.

[0066] 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.

[0067] In addition, nitinol (NiTi) may be used as the material of the frame orstent (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.

[0068] The invention of this application has been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Claims

WHAT IS CLAIMED IS:

1. An implantable medical device comprising: a frame operable to transition between a delivery configuration and a deployed configuration; a tubular member supported by the frame and defining a side wall, wherein the tubular member defines a main lumen extending therethrough and at least one fenestration defined by the side wall; at least one branch member positioned within the main lumen of the tubular member, each branch member of the at least one branch member being coupled to the side wall to define a sealing with the fenestration such each fenestration is in fluid communication with the main lumen via a corresponding branch member; and a valve supported by the frame and positioned within the main lumen upstream from the at least one fenestration and operable to control fluid transport through the lumen when implanted in an ascending aorta.

2. The implantable medical device of claim 1 , wherein the valve includes at least one leaflet configured to allow antegrade blood flow and resist retrograde blood flow.

3. The implantable medical device of claim 2, wherein the at least one leaflet is an extension of the tubular member such that the extension is indirectly supported by the frame.

4. The implantable medical device of claim 3, wherein the extension is an inverted portion of the tubular member.

5. The implantable medical device of claim 4, wherein the extension is selectively bonded to an inner surface of the side wall to define commissures of two or more of the at least one leaflet.

6. The implantable medical device of any one of claims 1-5, wherein the at least one branch member defines a branch lumen between a first end and a second end, whereineach second end of each of the at least one branch member is coupled to the side wall at a corresponding fenestration.

7. The implantable medical device of claim 6, wherein each second end of each of the at least one branch member is coupled to the side wall proximate the corresponding fenestration of each of the at least one fenestration such that each branch lumen is in fluid communication with the corresponding fenestration of each of the at least one fenestration.

8. The implantable medical device of any one of claims 6-7, wherein each branch lumen is positioned in a retrograde orientation.

9. The implantable medical device of any one of claims 6-7, wherein each branch lumen is positioned in an antegrade orientation.

10. The implantable medical device of any one of claims 1-9, wherein the at least one fenestration is configured to receive a corresponding stent graft, the corresponding stent graft configured to perfuse at least one side branch vessel.

11. The implantable medical device of any one of claims 1-10, wherein the frame and tubular member define a first end and a second end, wherein the first end includes an engagement portion configured to be positioned across a native aortic valve.

12. The implantable medical device of claim 11 , wherein the engagement portion includes retention members operable to engage leaflets of a native aortic valve to limit migration of the leaflets toward a heart of a patient.

13. The implantable medical device of claim 11 , wherein the first end is configured to be positioned upstream from coronary ostia and the second end is configured to be positioned within an ascending aorta downstream from the coronary ostia.

14. The implantable medical device of claim 11 , wherein the side wall is configured to receive a secondary implantable prosthetic valve such that the valve is disabled when the secondary implantable prosthetic valve is received.

15. The implantable medical device of claim 14, wherein at least one leaflet of the valve is configured to be positioned against the side wall when the secondary implantable prosthetic valve is received so as to maintain fluid communication through the at least one fenestration.

16. The implantable medical device of any one of claims 1-15, wherein the frame is tapered to have a diameter that is smaller at a first end than a diameter at a second end.

17. The implantable medical device of any one of claims 1-16, wherein the valve includes a plurality of leaflets defining commissures, wherein each fenestration of the at least one fenestration aligns with a corresponding commissure of the commissures.

18. An implantable medical device comprising: a frame operable to expand from a delivery configuration to a deployed configuration, the frame defining a first end, a second end, and an intermediate portion; and a tubular member supported by the frame and defining a side wall, wherein the tubular member includes a first end portion and second end portions, the tubular member defining a main lumen extending therethrough and at least one fenestration defined by the side wall proximate the intermediate portion of the frame, the first end portion being inverted into the main lumen and defining a valve at a first end of the frame.

19. A method of deploying an implantable medical device, comprising: advancing, transvascularly, the implantable medical device to an ascending aorta, the implantable medical device including a frame operable to expand from a delivery configuration to a deployed configuration, a tubular member supported by the frame and defining a side wall, wherein the tubular member defines a main lumen extending therethrough and at least one fenestration defined by the side wall, the tubular member including at least one branch member positioned within the main lumen, each branch member of the at least one branch member being coupled to the side wallto define a sealing with the fenestration such each fenestration is in fluid communication with the main lumen via a corresponding branch member, and a valve supported by the frame and positioned within the main lumen upstream from the at least one fenestration and operable to control fluid transport through the lumen when implanted; and deploying the implantable medical device in the ascending aorta such that a portion of the implantable medical device is positioned in an aortic annulus and the at least one fenestration is positioned proximate a corresponding coronary artery.

20. The method of claim 19, further comprising: advancing at least one side branch stent graft to the implantable medical device; and deploying each of the at least one side branch stent graft in a corresponding fenestration of the at least one fenestration and the corresponding coronary artery.

21. The method of claim 20, further comprising advancing a secondary implantable prosthetic valve to the implantable medical device.

22. The method of claim 21 , further comprising deploying the secondary implantable prosthetic valve proximate the valve of the implantable medical device.

23. The method of claim 22, wherein deploying the secondary implantable prosthetic valve disables the valve of the implantable medical device.

24. The method of claim 23, wherein deploying the secondary implantable prosthetic valve sandwiches leaflets of the valve of the implantable medical device between the side wall of the implantable medical device and the secondary implantable prosthetic valve such that the at least one fenestration is not covered by the leaflets of the valve of the implantable medical device and is not covered by the secondary implantable prosthetic valve.

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