Stent graft and delivery system with secondary guidewire lumen

Abstract

A stent graft delivery system and methods for deployment are provided. The stent graft delivery system includes a stent graft cover defining an opening extending radially therethrough. A stent graft is disposed within the stent graft cover in a constricted configuration, whereupon it can expand outwardly when the stent graft cover is withdrawn. The stent graft includes a fenestration extending radially therethrough. A primary guidewire lumen is configured to receive a primary guidewire, and extends axially through the stent graft from a proximal end of the stent graft to a distal end of the stent graft. A secondary guidewire lumen is configured to receive a secondary guidewire, and extends from the opening of the stent graft cover and through the fenestration of the stent graft when the stent graft is in the constricted configuration.

Description

STENT GRAFT AND DELIVERY SYSTEM WITH SECONDARY GUIDEWIRE LUMENCROSS- REFERENCE TO RELATED APPLICATIONS|0001] This application claims the benefit of U.S. provisional application Serial No. 63 / 555,216 filed February 19, 2024, the disclosure of which is hereby incorporated in its entirety by reference herein.TECHNICAL FIELD

[0002] The present disclosure relates to a stent graft and an associated delivery system with a secondary7guidewire lumen. In embodiments, the present disclosure relates to a stent graft delivery' system with a secondary' guidewire lumen that extends through a secondary fenestration or branch of a stent graft compressed within the delivery system.BACKGROUND

[0003] The use of endovascular procedures has been established as a minimally invasive technique to deliver a variety of clinical treatments in a patient's vasculature. A stent graft is an implantable device made of a tube-shaped surgical graft covering and an expanding or self-expanding frame. The stent graft is placed inside a blood vessel to bridge, for example, an aneurismal, dissected, or other diseased segment of the blood vessel, and, thereby, exclude the hemodynamic pressures of blood flow from the diseased segment of the blood vessel.[000 1 Depending on the region of the aorta involved, the aneurysm may extend into areas having vessel bifurcations or segments of the aorta from which smaller “branch” arteries extend. For example, thoracic aortic aneurysms can include aneurysms present in the ascending thoracic aorta, the aortic arch, and / or branch arteries that emanate therefrom, such as subclavian or left or right common carotid arteries. In some cases, a branched stent graft can be used to treat such aneury sms. For example, a main stent graft can be deployed in the main vessel (e.g., aortic arch), and a supplemental, secondary stent graft can be deployed in the branched artery (e.g., left subclavian).SUMMARY[0005 j According to an embodiment, a stent graft delivery system is configured to deliver and deploy a stent graft within a blood vessel. The stent graft delivery system comprises a stent graft cover defining an opening extending radially therethrough. The stent graft delivery system comprises a stent graft disposed within the stent graft cover in a constricted configuration, wherein the stent graft includes a fenestration extending radially therethrough. The stent graft delivery system comprises a primary guidewire lumen configured to receive a primary guidewire, wherein the primary guidewire lumen extends axially through the stent graft from a proximal end of the stent graft to a distal end of the stent graft. The stent graft delivery system includes a secondary guidewire lumen configured to receive a secondary guidewire, wherein the secondary guidewire lumen extends from the opening of the stent graft cover and through the fenestration of the stent graft when the stent graft is in the constricted configuration.

[0006] In embodiments, the secondary guidewire lumen extends axially through a distal end of the stent graft and radially through the fenestration of the stent graft.

[0007] In embodiments, the secondary guidewire lumen is fixed relative to the stent graft cover and terminates at the opening of the stent graft cover.[0008J In embodiments, the secondary guidewire lumen extends radially outward from the stent graft cover through the opening of the stent graft cover.[0009j In embodiments, the secondary guidewire lumen extends axially and distally beyond the stent graft cover.

[0010] In embodiments, the stent graft delivery system further comprises a middle member disposed within the stent graft cover and proximally from the stent graft, wherein the middle member has a hollow interior that surrounds the primary guidewire lumen, and wherein the middle member defines an axially-extending split extending from a proximal end to a distal end thereof. The axially -extending split can receive the second guidewire lumen.[00111 In embodiments, the fenestration is configured to be aligned with a left subclavian artery when the stent graft is in a deployed configuration.[0012[ In embodiments, the stent graft includes a second fenestration located sized and configured to enable blood flow through the second fenestration and into both a brachiocephalic artery (BCA) and a left common carotid artery (LCCA) when the stent is in a deployed configuration.

[0013] According to another embodiment, a stent graft delivery system is configured to deliver and deploy a stent graft within a blood vessel. The stent graft delivery system comprises a stent graft cover having an opening extending through the stent graft cover in a radial direction. The stent graft delivery system comprises a stent graft disposed within the stent graft cover in a constricted configuration, wherein the stent graft has a fabricated fenestration extending through the stent graft in the radial direction. The stent graft delivery system comprises a guidewire lumen configured to receive a guidewire, wherein the guidewire lumen extends between and connects the opening of the stent graft cover and the fenestration of the stent graft when the stent graft is in the constricted configuration, enabling a guidewire to be inserted into the guidewire lumen through the opening in the stent graft cover and through the fenestration of the stent graft.

[0014] In embodiments, the guidewire lumen is a secondary guidewire lumen, and the stent graft delivery system further comprises a primary guidewire lumen configured to receive a primary guidewire, wherein the primary guidewire lumen extends axially through the stent graft from a proximal end of the stent graft to a distal end of the stent graft.IO015J In embodiments, the stent graft delivery system further comprises a middle member disposed within the stent graft cover and proximally from the stent graft, wherein the middle member has a hollow interior that surrounds the primary guidewire lumen.

[0016] In embodiments, the middle member defines an axially-extending split extending from a proximal end to a distal end thereof, and wherein the secondary guidewire lumen is disposed within the axially -extending split.

[0017] In embodiments, the secondary guidewire lumen is fixed relative to the stent graft cover and terminates at the opening of the stent graft cover.

[0018] In embodiments, the secondary' guidewire lumen extends radially outward from the stent graft cover through the opening of the stent graft cover.

[0019] In another embodiment, a method of delivering a stent graft to a blood vessel includes the following: inserting a main guidewire into the blood vessel; inserting a secondary guidewire into the blood vessel; inserting a catheter component into the blood vessel wherein the catheter component includes a stent graft cover surrounding a stent graft, a main guidewire lumen that tracks over the main guidewire, and a secondary guidewire lumen that tracks over the secondary guidewire, and wherein the secondary guidewire lumen extends within the catheter component between a radially -extending opening in the stent graft cover and a radially-extending fenestration in the stent graft; and withdrawing the stent graft cover to cause the stent graft to expand with the secondary' guidewire extending through the radially-extending fenestration in the stent graft.

[0020] In embodiments, the blood vessel is an aortic arch, and the method further comprises inserting the secondary' guidewire into a second blood vessel that branches from the aorta. The second blood vessel may be a left subclavian artery (LSA), and the method may further comprise: prior to the withdrawing, aligning the radially-extending fenestration in the stent graft with the LSA.

[0021] In embodiments, the method further comprises: prior to the inserting of the secondary guidewire into the blood vessel, preloading the secondary guidewire into the catheter component through the radially-extending fenestration in the stent graft via the secondary guidewire lumen.[00221 In embodiments, the method further comprises: prior to the inserting of the catheter member, snaring the secondary guidewire into a second blood vessel that branches from the blood vessel.BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG. 1 is a schematic side view of an anatomy of an aortic arch.

[0024] FIG. 2. is a schematic side view of an endoluminal stent graft, according to an embodiment.

[0025] FIG. 3 is a schematic side view of the stent graft of FIG. 2 deployed at a target location within an aortic arch, according to an embodiment.[0026J FIGS. 4A-4C are schematic views of a proximal region of the stent graft of FIG. 2, showing alternate embodiments of fenestrations in a graft material of the stent graft, according to embodiments.

[0027] FIGS. 5-8 are schematic illustrations of progressive steps of a method for delivering and deploying the stent graft of FIG. 2 within the aortic arch using a graft delivery system, according to an embodiment.

[0028] FIGS. 9A is a side view of a distal region of a stent graft delivery' system, according to an embodiment. FIG 9B is a perspective view of a region of the stent graft delivery system labeled BB in FIG. 9A. FIG. 9C is a perspective view of a region of the stent graft delivery system labeled CC in FIG. 9A.

[0029] FIG. 10 is a schematic side view of the stent graft of FIG. 2 in a deployed or expanded state with a secondary guidewire lumen extending through a fenestration of the stent graft, according to an embodiment.

[0030] FIGS. 11A is a side view of a distal region of a stent graft delivery system, according to another embodiment. FIG 1 IB is a perspective view of a region of the stent graft delivery system labeled BB in FIG. 1 1 A. FIG. 1 1 C is a perspective view of a region of the stent graft delivery' system labeled CC in FIG. 11 A.[00311 FIG. 12 is a perspective view of a portion of the stent graft delivery system with an outer cover removed to show components of according to an embodiment.[003 [ FIG. 13A is a perspective view of a portion of the outer cover of the stent graft delivery system, according to an embodiment. FIGS. 13B is a plan view of one side of the outer cover of the stent graft delivery system, and FIG. 13C is a plan view of a radially- opposing side (180 degrees) of the outer cover. FIGS 13D-E are plan views of the outer cover under x-ray at different rotational positions.DETAILED DESCRIPTION

[0033] Embodiments of the present disclosure are described herein. It is to be understood, however, that the disclosed embodiments are merely examples and other embodiments can take various and alternative forms. The figures are not necessarily to scale; some features could be exaggerated or minimized to show details of particular components.Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative bases for teaching one skilled in the art to variously employ the embodiments. As those of ordinary skill in the art will understand, various features illustrated and described with reference to any one of the figures can be combined with features illustrated in one or more other figures to produce embodiments that are not explicitly illustrated or described. The combinations of features illustrated provide representative embodiments for typical application. Various combinations and modifications of the features consistent with the teachings of this disclosure, however, could be desired for particular applications or implementations.[0034| "A". "ail”, and "the" as used herein refers to both singular and plural referents unless the context clearly dictates otherwise. By way of example, “a processor” programmed to perform various functions refers to one processor programmed to perform each and every function, or more than one processor collectively programmed to perform each of the various functions.

[0035] Directional terms used herein are made with reference to the views and orientations shown in the exemplary figures. A central axis is shown in the figures and described below. Terms such as "outer" and “inner” are relative to the central axis. For example, an “outer” surface means that the surfaces faces away from the central axis, or is outboard of another “inner” surface. Terms such as “radial,” “axial,” “diameter,” “circumference,” etc. also are relative to the central axis. For example, the “axial” direction refers to a direction parallel to a central axis of a stent graft. The terms “front.” “rear,” “upper” and “lower” designate directions in the drawings to which reference is made.

[0036] Unless otherwise indicated, for the delivery7system the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to a treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction tow ard the clinician. For the stent-graft prosthesis, “proximal” is the portion nearer the heart by w ay of blood flow- path while “distal” is the portion of the stent-graft further from the heart by way of blood flow path.

[0037] The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although thedescription is in the context of treatment of blood vessels such as the aorta, coronary', carotid and renal arteries, the invention may also be used in any other body passageways where it is deemed useful.

[0038] Embodiments hereof relate to a modular assembly or system configured to perfuse the aortic arch via an endovascular approach. FIG. 1 illustrates a schematic side view of an anatomy of an aortic arch (labeled as "‘AA” in the figures). Illustrated here are the primary branch vessels of the aortic arch - the brachiocephalic artery (BCA), the left common carotid artery' (LCCA), and the left subclavian artery' (LSA). In some cases, a modular approach such as a branched stent graft can be used to treat such aneurysms. For example, a main stent graft can be deployed in the aortic arch (AA), and a supplemental, secondary stent graft can be deployed in the branched artery (e g., BCA, LCCA, and / or LSA). Adoption of branched stent grafts has been limited by, among other things, the short distances between the primary' branch vessels of the aortic arch. Landing zone LI extends between the brachiocephalic artery (BCA) and the left common carotid artery (LCCA), while landing zone L2 extends between the left common carotid artery (LCCA) and the left subclavian artery (LSA). These landing zones LI and L2 are suitable places to mount stent grafts to the wall of the aortic arch. However, the landing zones, LI and L2, are typically insufficient for a durable and sufficient overlap of adjacent modular components that may be deployed within the aortic arch. Insufficient overlap of adjacent modular components would leave the modular system prone to development of leaks. The problem of separation of modular components is exacerbated by the dynamic environment of the aortic arch where there is extensive cardiac and respiratory' induced motion.

[0039] FIG. 2 shows a stent graft 100 configured for placement in a blood vessel. FIG. 3 shows the stent graft 100 deployed in the aortic arch (AA). In the illustrated embodiment, the blood vessel in which the stent graft 100 is deployed is the aorta, but it should be understood that teachings herein can apply to other blood vessels. Referring to FIGS. 2 and 3, the stent graft 100 can be self-expanding, in that it includes structures that are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration. In this embodiment, the stent graft 100 includes two main components: a tubular graft 102 (also referred to as a body), and one or more stents 104 for supporting and expanding the graft 102. The graft 102 may be formed from any suitable graft material, for example and not limited to, a low-porosity woven or knit polyester, DACRON material, expanded polytetrafluoroethylene,polyurethane, silicone, or other suitable materials. In another embodiment, the graft material is a natural material such as pericardium or another membranous tissue such as intestinal submucosa. The stents 104 are radially-compressible and expandable, and are coupled (e.g., via stitching) to the material of the graft 102 for supporting the graft 102. The stents 104 are operable to self-expand into apposition with the interior wall of the aorta. Each stent 104 is constructed from a self-expanding or spring material, such as but not limited to nickel-titanium alloy (Nitinol), stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal, or other suitable material. The stents 104 may be a sinusoidal patterned ring including a plurality of crowns 106 or bends and a plurality of struts 108 or straight segments with each crown 106 being formed between a pair of opposing struts 108. jOO4O] The stent graft 100 includes a proximal end 110, a distal end 112, and a body 114 therebetween. The proximal end 110 may have a proximal stent 116. and the distal end 112 may have a distal stent 118. The proximal stent 116 and distal stent 118 may extend outside of or beyond the graft material 102, as shown, and may also be generally described as anchor stents or crown stents, configured to anchor to the inner walls of the vessel (e.g., AA). In other embodiments, one or both of the proximal stent 116 or distal stent 118 may not extend beyond the edge of the graft material. In some embodiments, the proximal end 110 may further include a support stent 119, which may be positioned between the proximal stent 116 and the first body stent (e.g., stents between proximal stent 116 and distal stent 118). The support stent may have a smaller diameter, a smaller amplitude, and / or a smaller period than the body stents. A smaller period may provide the support stent with more contact points along the proximal graft edge to promote sealing of the stent graft and reduce endoleaks.[00411 The body 114 of the stent graft 100 can include two fabricated fenestrations or openings, namely a first fenestration 120 and a second fenestration 122. These fenestrations 120, 122 can be openings in the body or graft 102 of the stent graft 100. In embodiments, the fenestrations 120, 122 are cut out or removed from the material of the graft 102. In other embodiments, the fenestrations 120, 122 are formed into the graft 102 upon manufacturing of the stent graft 102. The first fenestration 120 is located closer to the proximal end 110 than the second fenestration 122 is. The fenestrations shown in FIGS. 2, 4A, and 10 are similar to those patented in U.S. Patent No. 12,186,177 by Canaud and Gandet (hereinafter "the Canaud Patent”).

[0042] In embodiments, the first fenestration 120 is at a location of the body 114 that aligns with both the BCA and the LCC when the stent graft 100 is deployed within the AA. The first fenestration 120 can therefore be referred to as an LCCA fenestration. For example, the stent graft 100 may be deployed in the AA with the proximal stent 1 16 positioned proximal of the BCA, allowing the first fenestration 120 to align wi th the BCA and LCCA, thus allowing blood flow through the stent graft 100 and into the BCA and LCCA. The second fenestration 122 is at a location of the body 1 14 that aligns with the LSA. The second fenestration 122 can therefore be referred to as an LSA fenestration. This allows for a secondary guidewire to pass therethrough, allowing for assembly of a modular component such as a secondary' stent graft (not shown) to be attached within the LSA. f 0043 Referring to FIG. 2 and FIG. 4A, the first fenestration 120 may be in the general shape of an irregular pentagon with a proximal edge 124 extending in the circumferential direction and perpendicular to a central axis A of the stent graft 100. The proximal edge 124 intersects a first axial edge 126 and a second axial edge 128 that extend in the axial direction of the stent graft 100 (although in embodiments described herein, the second axial edge 128 is curved relative to the axial direction). The first axial edge 126 intersects a first distal edge 130, and the second axial edge 128 intersects a second distal edge 132. The first distal edge 130 and the second distal edge 132 are angled (e.g., not parallel to) relative to the axial direction from the viewpoint of FIG. 2. The first distal edge 130 and the second distal edge 132 intersect at a distal point 134 of the first fenestration 120. The distal point 134 may be adjacent to and just proximal to a trough formed by a body stent. In the embodiment of FIG. 2, the first fenestration 120 and the second fenestration 122 are aligned along an axis parallel to the central axis A. However, as explained below, in the embodiment of FIG. 4A, the second fenestration 122 is offset from the first fenestration 120 and the axis.

[0044] As shown in FIG. 2, the shape of the first fenestration 120 may be generally similar to the fenestration shown in the Canaud Patent, with some minor differences. For example, the second axial edge 128 may be arced or curved relative to the axial direction. This curve shape can be configured to accommodate the orientation or location of the BCA of the patient. The first axial edge 126 can extend parallel to the axial direction, as shown here, or in other embodiments can be curved similar to the second axial edge 128 (e g., mirrored).

[0045] To give some context and relative special dimensions of the fenestrations, the following measurements are provided. However, it should be understood that these are merelyexemplary and not meant to be limiting on the invention unless otherwise stated. In embodiments, the axial distance from the proximal edge 124 to the distal point 134 is between 10-50 millimeters (mm), or between 15-45 mm, or between 20-40 mm, or between 25-35 mm, or approximately 30 millimeters (mm). In embodiments, the axial distance from the distal point 134 to the second fenestration 122 is between 1-10 mm, or between 3-7 mm, or approximately 5 mm. In embodiments, the second fenestration has a diameter of approximately 8-12 mm, or approximately 10 mm. In embodiments, the radius of curvature of the curve shape of the second axial edge 128 can be between 5-15 mm, or between 7-12 mm, or approximately 10 mm.[0046| Further, each of the first distal edge 130 and the second distal edge 132 can be cut to follow the shape of the stent 104 (e.g., converging in the distal direction). In embodiments, the first distal edge 130 and the second distal edge 132 are located approximately 1-2 mm from the stent 104.

[0047] FIGS. 4A-4C illustrate alternate embodiments of the first fenestration 120 and / or second fenestration 122. In FIG. 4A, the second fenestration 122’ is located off-center from the first fenestration 120. In other words, the second fenestration 122’ is not centered with a central axis A of the stent graft that intersects the distal point 134. The central axis A also intersects a bend 106 of a stent 104, and a center of the second fenestration 122’ is not axially aligned with the axis A or this bend 106. In the embodiment shown, fenestration 122’ is disposed on the left of axis A, which would correspond to an anterior side in the deployed position. In another embodiment, the fenestration 122’ may be disposed on the right / posterior side. Configuring the fenestration 122’ may increase the chance that the fenestrations 120 and 122 align with their target ostia.

[0048] In FIG. 4B, the first fenestration 120' takes the general shape of a rectangle. Specifically, the first fenestration 120’ includes a proximal edge 124. a first axial edge 126’. a second axial edge 128’ that is parallel to the first axial edge 126’, and a distal edge 136 that extends circumferentially and parallel to the proximal edge 124. This shape of the first fenestration 120' provides a larger opening for blood flow into the BCA and LCCA than the embodiment of FIG. 4A. The second fenestration 122 is axially aligned with the first fenestration 120’, although in other embodiments it may be offset as described above.

[0049] In FIG. 4C, the first fenestration 120” takes the general shape of a rectangle with a bulbous comer. Specifically, the first fenestration 120” includes a proximal edge 124, a first axial edge 126’, and a distal edge 136 that are similar to the embodiment of FIG. 4B. The first fenestration 120” includes a second axial edge 128” that has a rounded or bulbous region 138. This bulbous region 138 is similar to the curve of the second axial edge 128 of the first fenestration 124 of FIG. 4A. In the illustration embodiment, the bulbous region 138 has a proximal point that intersects the proximal edge 124, and a distal point that intersects the portion of the second axial edge 128” that is axially-extending. The point at which the bulbous region 138 ends and the axially-extending region of the second axial edge 128” begins can be approximately in the center of the second axial edge 128”, e.g. halfway between the proximal edge 124 and the distal edge 136. although this is not intended to be limiting. The bulbous region 138 provides a larger opening for blood flow into the BCA, and accommodates the orientation or location of the BCA of the patient.

[0050] In the embodiments shown in FIGS. 2 and 4A-4C. the proximal edge 124 is shown as extending circumferentially aligned approximately (e.g., within 3 mm) with the peaks of the first body stent (e.g., first stent distal to the support stent or, if there is no support stent, first stent distal to the proximal stent). The proximal edge may be offset slightly in the distal direction from the peaks, such as 1-3 mm. The fenestrations 120-120” may extend distally from proximal edge 124 to a trough of the directly adjacent and distal body stent, or slightly proximal thereto (e.g., within 5 mm). In other embodiments, the fenestrations 120 and 122 may be substantially similar, but may be shifted distally by one or more body stents. For example, instead of extending from the peak of the first body stent to the trough of the second body stent, the first fenestration 120 may extend from the peak of the second body stent to the trough of a third body stent.[0051 J While the embodiments of fenestration 122 are shown and described as openings or holes in the graft material (e.g., two-dimensional), in other embodiments the fenestration 122 may be replaced with a branch or coupling. Both fenestration 122 and a coupling may be configured to receive a branch stent graft that extends from the main stent graft and into the LSA. A branch or coupling, however, may have a three-dimensional shape instead of an opening. For example, the coupling may have a cylindrical or truncated cone shape that extends in a radial direction from the main stent graft with a lumen extending therethrough. A coupling may provide a longer sealing area with the main stent graft, whichmay improve the joint strength therebetween and / or reduce endoleaks. It is to be understood that any reference to fenestration 122 herein may also be contemplated as a branch or coupling.[00521 FIGS. 5-7 show beginning stages of a method of delivering and deploying the stent graft 100 within the aortic arch, according to an embodiment. In an embodiment disclosed herein, the stent graft 100 is delivered and deployed into the aortic arch. Portions of the aorta include the ascending aorta, the aortic arch (labeled as "A A" in the figures), and the descending aorta. Branching from the aortic arch are the BCA, the LCCA, and the LSA. An aneurysm (not show n) may form in any area of the aortic arch, and can be difficult to bypass or exclude with a single stent graft because blood How to the branch arteries must be maintained. Therefore, modular assemblies may be implemented in which a second stent graft is deployed into one of the other arteries. As previously stated, although the description of embodiments hereof is primarily in the context of modular devices for treating aneurysm disease within an aortic arch, the modular devices described herein can also be used to treat other aortic arch pathologies including but not limited to dissections, penetrating ulcers, intramural hematomas, transections, and pseudoaneurysms.[00531 FIG. 5 shows a primary guidewire or first guidewire GW1, and a secondary guidewire or second guidewire GW2 advanced through the descending aorta, through the aortic arch, and into the ascending aorta. In this embodiment, the second guidewire GW2 extends into the LSA so that during advancement of the delivery' system the second fenestration 122 of the stent graft 100 is aligned with the LSA. In other embodiments (not shown), the second guidewire GW2 extends into the BCA or LCCA for alignment of the the second fenestration of the stent graft. Guidewires GW1, GW2 are typically inserted into the femoral artery and routed up through the abdominal aorta, and into the thoracic aorta, as is known in the art. In another embodiment (not shown), guidewires GW1, GW2 can be introduced via supra aortic or transapical access.

[0054] Although not shown here, a snare or other capture device may be utilized to transfer the second guidewire GW2 into the LSA. For example, a snare can be inserted (e.g., via radial artery access) in the LSA distal from the aortic arch. The snare can capture the second guidewire GW2, and then retraction of the snare pulls the second guidewire GW2 into the LSA. The distal end of the second guidewire GW2 can be pulled until the second guidewire GW2 extends from the radial artery access to the iliac artery access, known as a through-and- through wire technique. The through-and-through access improves the ability7to stabilize andmanipulate second guidewire GW2 during the procedure. In addition, the through-and-through wire technique reduces the complexity’ of branch stent-graft deployment to the branch vessels in the case of axial or rotational misalignment or patient specific anatomical variation. f 0055] With the first guidewire GW1 and second guidewire GW2 properly positioned, a stent graft delivery system 200 can be inserted. FIG. 6 shows a stent graft delivery system 200, namely a portion of a catheter component with the stent graft 100 compressed therein, advanced over guidewires GW1, GW2 to the target location in the aortic arch. The location of the stent graft delivery system 200 and / or the contained stent graft 100 may be verified radiographically, for example via radiopaque markers as known in the art.[0056 J Once the stent graft delivery system 200 is in the proper position, an outer sleeve or sheath of the stent graft delivery' system 200 is retracted proximally to deploy the contained stent graft 100. FIG. 7 illustrates stent graft 100 deployed within the aorta, with first fenestration 120 aligned with both the BCA and the LCCA to allow blow to those arteries, and the second fenestration 122 aligned with the LSA with the second guidewire GW2 passing through the second fenestration 122. More particularly, the outer sleeve or sheath of the stent graft delivery' system 200 may initially be retracted proximally to a position such that the first fenestration 120 is properly aligned with the BCA and LCCA while the remainder of the stent graft 100 remains contained within the outer sleeve or sheath. Then, the outer sleeve or sheath can be further retracted proximally to expose the second fenestration 122, allowing properly alignment of the second fenestration 122 with the LSA. Once proper alignment is assured, the outer sleeve or sheath of the stent graft delivery system 200 may be further retracted to deploy the remaining length of the stent graft 100. Thereafter, the stent graft delivery system 200 may be removed, leaving stent graft 100 deployed in situ as shown in FIG. 7 with first and second guidewires GW1, GW2 disposed therethrough.[00571 FIG. 8 shows an alternate embodiment of delivering the stent graft 100. Here, the main guidewire GW1 is inserted into the aortic arch, but the second guidewire GW2 is preloaded into the stent graft delivery system 200, through the second fenestration 122 of the stent graft 100. The stent graft delivery' system 200 with the preloaded second guidewire GW2 is inserted along the main guidewire GW1 until reaching the aortic arch. Then, the second guidewire GW2 may be extended / advanced from within the delivery system 200 (e.g., within or just proximal to the tip) and a snare 300 (e.g., inserted via radial artery access) in the LSA can capture the second guidewire GW2, and pull the second guidewire GW2 through the LSAand out the radial artery7access to achieve a through-and-through wire. Once the through-and- through is established, the outer sleeve or sheath of the stent graft delivery system 200 can be retracted to allow expansion of the stent graft, as explained above.|0058] FIG. 9A illustrates a distal region of the stent graft delivery system 200, according to a first embodiment. FIG. 9B shows a first region of the stent graft delivery system 200, and FIG. 9C shows a second region of the stent graft delivery system 200, e.g. a distal tip region. The stent graft delivery system 200 includes an outer sheath or stent graft cover 202 that contains, and constricts, the stent graft 100 within. The stent graft cover 202 is shown in FIG. 9B, but is removed in FIG. 9C for clarify of the components contained within the stent graft cover 202. The stent graft 100 assumes a constricted configuration when contained in the stent graft cover 202, as opposed to a deployed or expanded configuration when the stent graft cover 202 is retracted relative to the stent graft 100. The stent graft cover 202 may be formed from a composite material having a braided layer of poly ether block amide, such as PEBAX®, that is sandwiched between layers of polyamide, such as VESTAMID®. While not shown in the Figures, the stent graft delivery system 200 can include a handle operatively coupled to the stent graft cover 202 such that rotation or manipulation of a portion of the handle retracts the stent graft cover in the proximal direction, allowing the stent graft 100 to expand outwardly against a vessel wall.

[0059] The stent graft delivery7system 200 includes an inner lumen or primary guidewire lumen 204, and an outer lumen or secondary7guidewire lumen 206. The primary guidewire lumen 204 is sized and configured to receive the primary guidewire GW1, while the secondary guidewire lumen 206 is sized and configured to receive the secondary guidewire GW2. Each guidewire lumen 204, 206 may be made from a high tensile polymer, such as poly ether ether ketone (PEEK) or a poly imide. In embodiments, the primary guidew ire lumen 204 extends from a proximal end of the stent graft delivery system 200 and through the contained stent graft 100, ending at an opening in a tapered tip 208 at a distal end of the stent graft delivery7system 200. The primary guidewire lumen 204 may be centered in the stent graft delivery system 200 so that the primary7guidewire GW1 exits the stent graft delivery system 200 at a center opening of the tip 208, although in other embodiments the primary7guidew ire lumen 204 is not centered. The primary guidewire lumen 204 may be fixed to the tapered tip 208 in alignment with the center opening at the distal end of the tip 208 to receive the mainguidewire GW1 therethrough and track along the main guidewire during insertion into the patient.[00601 The secondary guidewire lumen 206 is offset from the primary guidewire lumen 204. In this illustrated embodiment, a proximal end of the secondary guidewire lumen 206 extends through a radial opening 210 in the wall of the stent graft cover 202. A distal end of the secondary guidewire lumen 206 extends axially within the stent graft cover from the radial opening 210 to a distal end 211 of the stent graft cover 202 adjacent the tip 208. At the distal end, the secondary' guidewire lumen 206 may be disposed within a channel or groove in the tapered tip. In some embodiments, the secondary guidewire lumen 206 may terminate at the distal end of the stent graft cover 202. In other embodiments, as shown, the secondary guidewire lumen 206 may extend past the stent graft cover and into a channel or groove in the tapered tip, terminating, for example, proximal to the end of the tapered tip. An access port 212 is connected to the secondary guidewire lumen 206 at its proximal end. During a surgical procedure, a surgical clinician may insert the secondary guidewire GW2 through the secondary guidewire lumen 206 via the access port 212. The location of the access port 212 and opening 210 may be located more proximal or more distal than the position illustrated in FIG. 9A. In at least one embodiment, the stent graft cover 202 may have a braided portion (e.g., distal portion) and a non-braided portion (e.g., proximal portion). In one embodiment, the opening 210 may be disposed adjacent the transition from the non-braided portion to the braided portion, for example, on the non-braided side of the transition.

[0061] The secondary guidewire lumen 206 extends within the stent graft cover 202 from the opening 210 towards the distal end of the delivery’ system. It extends between the graft cover and the inner lumen, entering and extending within lumen at the distal end of the stent graft 100. The secondary’ guidewire lumen 206 then extends through the second fenestration 122 of the stent graft 100 to exit the stent graft 100 and extend along its outer surface, as shown in FIGS. 9C and 10, but still within the graft cover 202. This allows the secondary’ guidewire GW2 to extend through the second fenestration 122 when the stent graft 100 is in a compressed state w ithin the stent graft cover 202, and when the stent graft 100 is in the expanded state within the vessel. FIG. 10 illustrates how the stent graft 100 and secondary’ guidewire lumen 206 may look prior to compressing the stent graft 100 into the delivery system 200. For example, during a surgical procedure, the delivery system 200 can track along the two guidewires GW1, GW2 as shown in FIGS. 5-6 until reaching a desired location in the vessel.At that point, the physician may remove the secondary' guidewire lumen 206 by pulling on the access port 212 or proximal end of the lumen, thereby leaving only the secondary’ guidewire GW2 in place. Alternatively, the physician may have already removed the secondary guidewire lumen 206 after insertion of secondary guidewire GW2 but prior to introducing the delivery system into the patient’s anatomy (or after partial insertion but before access port 212 reaches the incision site). Thereafter, retraction of the stent graft cover 202 allows the stent graft 100 to expand within the vessel, with the second guidewire GW2 extending through the second fenestration 122, as shown in FIG. 7. This allows for a subsequent insertion and deployment of another stent graft through the second fenestration 122 along the second guidewire GW2, for example.[0062| FIG. HA illustrates a distal region of the stent graft delivery^ system 200 according to a second embodiment, and FIGS. 1 IB-11C show two different regions of the stent graft assembly 200. In this embodiment, the secondary guidewire lumen 206 is integrated into or attached to at least a portion of the stent graft cover 202, such as the opening 210. Specifically, a proximal end of the secondary guidewire lumen 206 terminates at the radial opening 210 of the stent graft cover 202. Once again, the stent graft cover 202 is shown in FIG. 1 IB, but is removed in FIG. 11C for clarify of the components contained within the stent graft cover 202. The proximal end of the secondary guideyvire lumen 206 may be connected to the stent graft cover around the radial opening 210 or proximate thereto by any suitable mechanism, such as adhesive, yvelding, mechanical interlock, or others. Accordingly, as the stent graft cover 202 is moved axially (e.g., retracted), the guideyvire lumen 206 may move along yvith it. Thus, an access port 212 may not be necessary in this embodiment and no part of the secondary guidewire lumen 206 extends proximal of the opening 210 or radially’ outward of the stent graft cover 202.[006 | Additionally, in this embodiment, a distal end of the secondary guidewire lumen 206 terminates yvithin and at the distal end 211 of the stent graft cover 202, as shown in FIG. 1 1C. Thus, no part of the secondary guidewire lumen 206 extends distally beyond the stent graft cover 202. In other examples, the secondary guideyvire lumen 206 may extend distally beyond the stent graft cover, for example, yvithin a groove or channel in the tapered tip. In this embodiment, the secondary guidewire lumen 206 is fixed (either directly or indirectly) to the stent graft cover 202, whereas in the embodiment of FIG. 9A-C the secondary guidewire lumen 206 may be inserted or slide relative to the stent graft cover 202. For example, the secondaryguidewire lumen 206 may be its own dedicated lumen that is attached to the stent graft cover 202, or in other embodiments, at least a portion of the stent graft cover 202 defines a wall of the secondary guidewire lumen 206, e.g., the two components are fused or manufactured as one continuous material.

[0064] The stent graft delivery system 200 may also include a middle member 220, a portion of which is enlarged in the view of FIG. 12. The middle member 220 extends along the center axis of the stent graft delivery system 200 and is located radially inward of the stent graft cover 202. The middle member 220 has a hollow interior sized to receive and fit around the primary guidewire lumen 204. The middle member 220 is slidable relative to the stent graft cover 202 (not shown in FIG. 12) such that retraction of the stent graft cover 202 does not cause retraction of the middle member 220.

[0065] The middle member 220 can be coupled (e.g., fixed) to and / or receive the first and second guidewire lumens 204. 206. In the illustrated embodiment, the middle member has a proximal end 222 and a distal end 224. The distal end 224 is located at or near the proximal end of the stent graft 100. The distal end 224 of the middle member 220 can be cup-shaped or otherwise radially enlarged compared to a central region of the middle member 220. This enlarged area allows for the containment of the primary guidewire lumen 204, the secondary guidewire lumen 206, and the distal end of the stent graft 100. The enlarged distal end 224 may serve as a stop to the distal end of the stent graft 100 as it is being deployed, preventing it from sliding proximally as the graft cover is retracted. To accommodate the secondary' guidewire lumen 206. the middle member 220 can include a longitudinal opening or channel 226 (e.g., trench, split, slot, pocket, etc.) extending axially through the middle member 220. The channel 226 can extend from a proximal end of the middle member 220 to and through the distal end 224. Alternatively, the opening 226 is provided only in the enlarged distal end 224 of the middle member 220, but not the remainder of the middle member; in such an embodiment the secondary guidewire lumen 206 can be disposed along an outer surface of the middle member rather than extending through an opening that extends longitudinally across the entire middle member 220. However, in the illustrated embodiment, the opening 226 splits the middle member 220 such that the middle member 220 assumes a C-shaped cross-section. The longitudinal opening 226 is sized and configured to contain the secondary lumen 206 therein. Accordingly, in at least one embodiment, the opening 226 may be circumferentially alignedwith opening 210 and / or a groove in the tapered tip that is configured to receive the secondary lumen 206.[00661 FIG. 13A is a perspective view of a distal portion of the outer cover 202 of the stent graft delivery system 200, according to an embodiment. In this embodiment, the outer cover 202 is provided with an alignment system 300. The alignment system 300 is configured to enable a surgical technician to visually understand the current rotational alignment of the stent graft delivery system 200 (and thus the fenestrations of the contained stent graft) when positioned intravenous and prior to deployment of the stent graft. In particular, one or more of the fenestrations described above can be oriented relative to the alignment system 300 such that when the alignment system 300 indicates a desirable rotational orientation, the surgical technician can know of the corresponding rotational orientation of the fenestrations of the stent graft. For clarity of the illustration, the inner components disposed within the outer cover 202 (e.g., the stent graft, the lumens, etc.) are not shown.

[0067] The alignment system 300 can include a plurality of radiopaque markers. For example, in the illustrated embodiment shown in FIGS. 13A-13E, the alignment system 300 can include a first radiopaque marker 302 and a second radiopaque marker 304. The radiopaque markers 302, 304 are made of a radiopaque material such as (but not limited to) tungsten, tantalum, platinum, platinum and iridium alloy, rhenium, gold, molybdenum, silver, and alloys containing one or more thereof. The radiopaque material are visible during intravenous procedures when viewed with imaging technologies (e.g., x-ray).|0068] The radiopaque markers 302, 304 can be axially aligned on the outer cover 202, but radially opposite from one another. For example, the first radiopaque marker 302 can be located on one radial side of the outer cover 202 as shown in FIG. 13B, and the second radiopaque marker 304 can be located on an opposite radial side (e.g., 180 degrees) of the outer cover 202 as shown in FIG. 13C.

[0069] When subjected to imaging technology, both radiopaque markers 302, 304 are simultaneously visible, allowing the surgical technician to rotate the stent graft delivery system 200 (and thus the contained stent graft) to a desired orientation. During a surgical procedure, the technician can rotate the delivery system 200 such that the two radiopaque markers 302, 304 are aligned with one another. The fenestrations described above (e.g., fenestration 120, 122) can be oriented 90 degrees relative to the radiopaque markers 302, 304. Thus, if the firstradiopaque marker 302 is rotationally aligned with the second radiopaque marker 304 as shown in FIG. 13D, the technician would understand that the fenestration(s) would be located radially at the top (or bottom) of the stent graft cover 202 in the view shown in FIG. 13D. In contrast, if the first radiopaque marker 302 is not rotationally aligned with the second radiopaque marker 304 as shown in FIG. 13E, the technician would understand that the fenestration(s) are not aligned with the top (or bottom) of the stent graft cover in the view shown in FIG. 13E.

[0070] FIGS. 13A-13E illustrate merely one example of the shape and size of the radiopaque markers 302, 304, and this disclosure is not limited to this embodiment. Nevertheless, in this embodiment, the first radiopaque marker 302 is an oval shape, and the second radiopaque marker 304 is a dot or circle shape. The technician can rotate the stent graft delivery system such that the dot or circle shape is positioned within the confines of the oval. This assures radial alignment of the first and second radiopaque markers 302, 304 and thus an understanding of the radial orientation of the stent graft and its fenestration(s). Of course, in other embodiments, the radiopaque markers are other shapes such as triangles, squares, rectangles, lines, and the like.[0071 J It should also be understood that the radiopaque markers 302, 304 can be disposed on one or more components within the outer cover 202 rather than on the outer cover itself. For example, while not illustrated here, the radiopaque markers can be integrated with or formed onto the stent graft 100.[00721 While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms encompassed by the claims. The words used in the specification are words of description rather than limitation, and it is understood that various changes can be made without departing from the spirit and scope of the disclosure. As previously described, the features of various embodiments can be combined to form further embodiments of the invention that may not be explicitly described or illustrated. While various embodiments could have been described as providing advantages or being preferred over other embodiments or prior art implementations with respect to one or more desired characteristics, those of ordinary skill in the art recognize that one or more features or characteristics can be compromised to achieve desired overall system attributes, which depend on the specific application and implementation. These attributes can include, but are not limited to cost, strength, durability, life cycle cost, marketability, appearance, packaging, size, serviceability, weight, manufacturability, ease of assembly, etc. As such, to the extent any embodiments aredescribed as less desirable than other embodiments or prior art implementations with respect to one or more characteristics, these embodiments are not outside the scope of the disclosure and can be desirable for particular applications.

Claims

WHAT IS CLAIMED IS:

1. A stent graft deliver}’ system configured to deliver and deploy a stent graft (100) within a blood vessel, the stent graft delivery system comprising: a stent graft cover (202) defining an opening (210) extending radially therethrough; a stent graft (100) disposed within the stent graft cover (202) in a constricted configuration, wherein the stent graft (100) includes a fenestration (122) extending radially therethrough; a primary guidewire lumen (204) configured to receive a primary guidewire (GW1), wherein the primary guidewire lumen (204) extends axially through the stent graft (100) from a proximal end of the stent graft to a distal end of the stent graft (100); and a secondary’ guidewire lumen (206) configured to receive a secondary' guidewire (GW2), wherein the secondary' guidewire lumen (206) extends from the opening (210) of the stent graft cover (200) and through the fenestration (122) of the stent graft (100) when the stent graft (100) is in the constricted configuration.

2. The stent graft delivery system of claim 1, wherein the secondary guidewire lumen (206) extends axially through a distal end of the stent graft and radially through the fenestration (122) of the stent graft.

3. The stent graft cover of claim 1 , wherein the secondary’ guidew ire lumen (206) is fixed relative to the stent graft cover (202) and terminates at the opening (210) of the stent graft cover (202).

4. The stent graft cover of claim 1 , wherein the secondary' guidewire lumen (206) extends radially outw ard from the stent graft cover (202) through the opening (120, 120’, 120”) of the stent graft cover.

5. The stent graft cover of claim 1, wherein the secondary guidewire lumen (206) extends axially and distally beyond the stent graft cover (202).

6. The stent graft delivery system of claim 1. further comprising a middle member (220) disposed within the stent graft cover (202) and proximally from the stent graft(100), wherein the middle member (220) has a hollow interior that surrounds the primary guidewire lumen (GW1), and wherein the middle member (220) defines an axially-extending split (226) extending from a proximal end (222) to a distal end (224) thereof.

7. The stent graft delivery system of claim 6, wherein the axially-extending split (226) receives the secondary guidewire lumen (206).

8. A stent graft deliver}' system configured to deliver and deploy a stent graft (100) within a blood vessel, the stent graft deliver}' system comprising: a stent graft cover (202) having an opening (210) extending through the stent graft cover (202) in a radial direction; a stent graft (100) disposed within the stent graft cover (202) in a constricted configuration, wherein the stent graft (100) has a fabricated fenestration (122) extending through the stent graft (100) in the radial direction; and a guidewire lumen (204, 206) configured to receive a guidewire (GW2), wherein the guidewire lumen (204, 206) extends between and connects the opening of the stent graft cover (202) and the fenestration (122) of the stent graft (100) when the stent graft (100) is in the constricted configuration, enabling a guidewire (GW2) to be inserted into the guidewire lumen (204, 206) through the opening (210) in the stent graft cover (202) and through the fenestration (122) of the stent graft (100).

11. The stent graft deliver}' system of claim 10, wherein the guidewire lumen is a secondary guidewire lumen (206), the stent graft delivery system further comprising: a primary guidewire lumen (204) configured to receive a primary guidewire (GW1), wherein the primary guidewire lumen (204) extends axially through the stent graft (100) from a proximal end of the stent graft to a distal end of the stent graft.

12. The stent graft delivery system of claim 11 , further comprising a middle member (220) disposed within the stent graft cover (202) and proximally from the stent graft (100), wherein the middle member (220) has a hollow interior that surrounds the primary guidewire lumen.

13. The stent graft delivery system of claim 12. wherein the middle member (220) defines an axially-extending split (226) extending from a proximal end (222) to a distalend (224) thereof, and wherein the secondary guidewire lumen (206) is disposed within the axially-extending split (226).

14. The stent graft delivery system of claim 10, wherein the secondary guidewire lumen (206) is fixed relative to the stent graft cover (202) and terminates at the opening (210) of the stent graft cover (202).

15. The stent graft delivery system of claim 10, wherein the secondary guidewire lumen (206) extends radially outward from the stent graft cover (202) through the opening (210) of the stent graft cover (202).

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