Stent Graft Assembly

Abstract

We provide stent graft assemblies. [Solution] A stent graft for deployment in the aortic arch, comprising a proximal stent ring at the proximal end of at least a tubular graft material, at least one fenestration provided on the side wall of the tubular graft material, and an internal branch positioned within the lumen of the stent graft and extending from the fenestration. The fenestration-supporting stent ring supports the fenestration between two struts and the apex of the fenestration-supporting ring. The proximal stent ring has a plurality of stent units, each comprising a scallop unit, a support unit, and a body unit. The proximal apex of each scallop unit is located on the laterally extending edge of the scallop within a first periphery region, and the proximal apex of each support unit is located within a second periphery region. The first and second struts of each scallop unit are shorter than the first and second struts of each support unit.

Description

Technical Field

[0001] Related Applications This application claims the benefit of UK Patent Application Nos. 2215296.1, 2215297.9, 2215299.5 and 2215295.3, the contents of which are incorporated herein by reference in their entirety.

[0002] The present invention relates to an endoluminal implantable medical device and a method of using the same. The endoluminal implantable medical device may be for insertion into the human vascular system.

Background Art

[0003] Endoluminal prostheses such as stents and stent grafts can be used to treat damaged or diseased blood vessels in the human body. For example, a stent graft can be used to repair an aneurysm of the thoracic aorta or abdominal aorta. Such a stent graft is placed within the blood vessel and provides some or all of the function of the original healthy blood vessel.

[0004] One problem in designing and using endoluminal prostheses is providing sufficient sealing of the prosthesis against the blood vessel wall. When the prosthesis is deployed within the blood vessel, if the seal is insufficient, leakage of blood flow between the prosthesis and the blood vessel wall - commonly referred to as endoleak - can occur, which can compromise the treatment of the patient as the aneurysm may grow without being decompressed.

[0005] Achieving sufficient sealing of the prosthesis becomes more difficult when the blood vessel is highly curved. Achieving sufficient sealing of the prosthesis also becomes difficult when the area of healthy tissue - also called the landing zone - where the prosthesis can seal is limited. For example, if the repair area is adjacent to a blood vessel branch or located between branches, the landing zone can be significantly restricted.

[0006] The aortic arch has been identified as a particularly difficult area to treat. In fact, designing and deploying prostheses that can address the complex topology of the aortic arch is challenging. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent No. 9,539,123 [Patent Document 2] U.S. Patent No. 7,238,198 [Patent Document 3] U.S. Patent No. 11,446,168 [Patent Document 4] U.S. Patent No. 10,537,419 [Patent Document 5] U.S. Patent No. 7,914,572 [Patent Document 6] U.S. Patent Application Publication No. 2019 / 0192275 [Patent Document 7] U.S. Patent No. 9,198,787 [Patent Document 8] European Patent Application Publication No. 4026518 [Patent Document 9] U.S. Patent Application Publication No. 2022 / 0211482 [Patent Document 10] U.S. Patent No. 9,855,128 [Patent Document 11] U.S. Patent No. 7,232,459 [Patent Document 12] U.S. Patent Application No. 63 / 581,548 [Overview of the Initiative] [Means for solving the problem]

[0008] The present invention aims to provide improved lumen-implantable medical devices and methods.Disclosed and described is a stent graft for deployment in the aortic arch, comprising a plurality of expandable stent rings arranged along the length of a tubular graft material having a proximal and distal end, the plurality of expandable stent rings including at least a proximal stent ring at the proximal end of the tubular graft material and a distal stent ring at or near the distal end of the tubular graft material and at least one intermediate stent ring between the proximal and distal stent rings; and at least one opening provided in the side wall of the tubular graft material; Internal branches positioned within the lumen and extending from the fenestration toward the end of the stent graft; first and second peripheral regions at the proximal end of the graft; scallops within the first peripheral region, including scallops longitudinally aligned with the fenestration, and at least one intermediate stent ring is a fenestration-supporting stent ring, the fenestration-supporting stent ring is a zigzag-shaped stent having a plurality of proximal apexes and a plurality of distal apexes, the proximal and distal apexes connected to each other by a plurality of stent struts extending between them, and at least one of the distal apexes is a fenestration-supporting stent ring The stent ring has a apex; at least one window is provided between two struts of the window-supporting stent ring, and the combination of the two struts of the window-supporting stent ring and the window-supporting apex defines two sides and a distal end of the window; the window has a proximal margin, the proximal margin includes at least a portion substantially perpendicular to the longitudinal axis of the stent graft; the proximal stent ring includes a plurality of stent units, each stent unit includes first and second struts connected by the proximal apex, the stent ring includes a plurality of distal apex, and each stent The unit is connected to an adjacent stent unit by its distal apex; a plurality of stent units include at least one scallop unit and at least one support unit, the proximal apex of each scallop unit located on the laterally extending edge of the scallop in a first periphery region, and the proximal apex of each support unit located in a second periphery region; the stent graft is such that the first and second struts of each of the at least one scallop unit are shorter than the first and second struts of each of the at least one support unit.

[0009] A stent graft for deployment in the aortic arch, comprising a plurality of expandable stent rings arranged along the length of a tubular graft material having a proximal end and a distal end, the plurality of expandable stent rings including at least a proximal stent ring at the proximal end of the tubular graft material and a distal stent ring at or near the distal end of the tubular graft material and at least one intermediate stent ring between the proximal and distal stent rings; at least one opening provided in the side wall of the tubular graft material; and positioned within the lumen and with an opening. Internal subbranches extending toward the end of the stent graft; first and second peripheral regions at the proximal end of the graft material; scallops within the first peripheral region, including a window and longitudinally aligned scallops, at least one intermediate stent ring is a window-supported stent ring, the window-supported stent ring is a zigzag stent having a plurality of proximal apexes and a plurality of distal apexes, the proximal and distal apexes connected to each other by a plurality of stent struts extending between them, at least one of the distal apexes is a window-supported apex; at least One window is provided between two struts of the window-supporting stent ring, and the combination of the two struts of the window-supporting stent ring and the window-supporting apex defines the two sides and distal end of the window; the window has a proximal margin, which includes at least a portion substantially perpendicular to the longitudinal axis of the stent graft; the proximal stent ring includes a plurality of stent units, each stent unit including first and second struts connected by the proximal apex; the stent ring includes a plurality of distal apex, each stent unit being connected by the distal apex Connected to adjacent stent units; each stent unit comprises a plurality of scallop units, each having a proximal apex, a plurality of support units, each having a proximal apex, and a plurality of body units, each having a proximal apex, wherein the proximal apex of each scallop unit is located on the laterally extending edge of the scallop within a first peripheral region, the proximal apex of each support unit is located within a second peripheral region, and the proximal apex of each body unit is located within a second peripheral region; the proximal apex of each scallop unit does not extend proximal to the graft material of the scallop;The first and second struts of each scallop unit are shorter than the first and second struts of each support unit, forming a stent graft.

[0010] A stent graft for deployment in the aortic arch, comprising: a plurality of expandable stent rings arranged along the length of a tubular graft material having a proximal and distal end, the plurality of expandable stent rings including at least a proximal stent ring at the proximal end of the tubular graft material and a distal stent ring at or near the distal end of the tubular graft material, and at least one intermediate stent ring between the proximal and distal stent rings; at least one fenestration provided in the side wall of the tubular graft material; internal subbranches positioned within the lumen and extending from the fenestration toward the end of the stent graft; first and second periphery regions at the proximal end of the graft material; a scallop within the first periphery region, aligning longitudinally with the fenestration; and at least one fitting tie at least partially circumferentially positioned around the distal end of the proximal stent ring and configured to tighten the diameter of the proximal stent ring. At least one intermediate stent ring is a fenestrated stent ring, which is a zigzag-shaped stent having a plurality of proximal apexes and a plurality of distal apexes, the proximal and distal apexes being connected to each other by a plurality of stent struts extending between them, and at least one of the distal apexes being a fenestrated apex; at least one fenestration is provided between two struts of the fenestrated stent ring, the combination of the two struts of the fenestrated stent ring and the fenestrated apex defining two sides and a distal end of the fenestration; the fenestration has a proximal margin, the proximal margin including at least a portion substantially perpendicular to the longitudinal axis of the stent graft; the proximal stent ring includes a plurality of stent units, each stent unit including first and second struts connected by a proximal apex, the stent ring includes a plurality of distal apexes, each stent unit being connected to an adjacent stent unit by a distal apex;A stent graft comprising a plurality of scallop units, each having a proximal apex, a plurality of support units, each having a proximal apex, and a plurality of body units, each having a proximal apex, wherein the proximal apex of each scallop unit is located on the laterally extending edge of the scallop within a first peripheral region, the proximal apex of each support unit is located within a second peripheral region, and the proximal apex of each body unit is located within a second peripheral region; the proximal apex of each scallop unit does not extend proximal to the graft material of the scallop; and the first and second struts of each scallop unit are shorter than the first and second struts of each support unit.

[0011] The present invention can be better understood by referring to the following drawings and description. The components are not necessarily to a constant scale unless otherwise specified, and instead the focus is on illustrating the principles of the invention. Furthermore, in the figures, similar reference figures indicate corresponding parts throughout different figures. [Brief explanation of the drawing]

[0012] [Figure 1] This is a frontal view of the proximal end of a prosthesis such as a stent graft. [Figure 2] Figure 1 is a schematic diagram showing a frontal view of the prosthesis. [Figure 3] This is a schematic diagram showing a lateral view of the prosthesis in Figure 1. [Figure 4] Figure 1 is an enlarged frontal view of the proximal end of the prosthesis. [Figure 5] This is a magnified view of a part of a prosthesis such as a stent graft. [Figure 6] Figure 1 shows the prosthesis in a partially unfolded state, as would be expected if it were placed within the patient's aortic arch and descending thoracic aorta. [Figure 7] Figure 6 shows a partial view of the proximal end of the prosthesis in a fully deployed state, as expected when deployed within the patient's aortic arch. [Figure 8]A schematic view of a stent suitable for use with the prosthesis of the present invention. [Figure 9] A second partial schematic view of the stent of FIG. 8. [Figure 10] A view of the proximal portion of a prosthesis including the stents of FIGS. 8 and 9. [Figure 11-12] A front view and a side view of the prosthesis shown in FIG. 10 are shown. [Figure 13] A front view of the proximal end of another prosthesis of the present invention is shown. [Figure 14] A front view of the prosthesis of FIG. 13 is shown. [Figure 15] Views from the proximal end of the prosthesis of FIGS. 13 to 14 are shown. [Figure 16] The prostheses of FIGS. 13 to 15 implanted in the aortic arch and descending thoracic aorta of a patient are shown, with the bridging stent graft filling the gap to the left subclavian artery.

Mode for Carrying Out the Invention

[0013] In the present disclosure, the terms "proximal" and "distal" refer to opposite directions with respect to the prosthesis. "Toward the proximal side" means the direction from the distal end to the proximal end of the prosthesis, and "toward the distal side" means the direction from the proximal end to the distal end of the prosthesis.

[0014] The specific embodiments described below are configured such that the proximal end is closest to the patient's heart during use. That is, in these embodiments, the term "proximal" refers to the position closest to the patient's heart during use, and the term "distal" refers to the position farthest from the patient's heart during use. However, other embodiments may be configured such that the distal end is used at the position closest to the patient's heart.

[0015] The present invention aims to provide an improved endoluminal implantable medical device and method. Specifically, the present invention provides a novel and improved stent graft for the treatment of a curved aortic lumen, particularly the aortic arch.

[0016] Figures 1-7 show a lumen implantable medical device in the form of a prosthesis 10. The prosthesis 10 is shown as a stent graft and is configured to be implanted in a curved lumen, such as the aortic arch and the descending thoracic aorta, as described below. The prosthesis 10 can also be configured to be implanted in lumens of various shapes, whether curved or not. Unless otherwise noted, the prosthesis is described in its expanded state, which is fully expanded and unrestricted. The prosthesis 10 includes a graft in the form of a tubular graft body 12, which includes side walls 14 through which an internal lumen 16 passes. The tubular graft body 12 has a proximal end 18 and a distal end 20 (shown in Figures 2 and 3). In this embodiment, the tubular graft body 12 is made of polyester woven fabric, but in other embodiments, it can be made of any suitable flexible and biocompatible material, including but not limited to PTFE, ePTFE, etc.

[0017] As shown in the partial view of the prosthesis 10 in Figure 1 and in Figures 2-3, the first proximal seal stent 22, which is at least partially located within the lumen 16, is positioned on the inner surface of the tubular graft body 12. The first proximal seal stent 22 is configured such that the proximal end 18 of the tubular graft body 12 forms a seal against the aortic wall. This inner seal stent 22 presents an essentially smooth outer surface that forms a seal against the aortic wall. The first proximal seal stent 22 may include a strut 24 having a bend / apex 26.

[0018] The apex 26 of the first proximal seal stent 22 includes a proximal apex 28 and a distal apex 30 (shown in Figures 2 and 3). As further shown in Figures 1-3, a scalloped opening 32 ("scallop"), further described below, may be present at the proximal end 18 of the tubular graft body 12, which is configured and designed to receive an arterial opening from one of the arteries of the aorta, for example, the aortic arch, in order to provide blood flow. A suitable structure of the scallop is disclosed and described in (Patent Document 1) ("Fenestrated Stent Grafts") to Hartley et al., published on January 10, 2017, the entire disclosure of which is incorporated herein by reference.

[0019] As shown in Figure 1, the proximal apex 28 of the first proximal seal stent 22 includes a body apex 34 and a scallop apex 36, as will be further detailed below. The scallop 32 includes a transverse edge 38 and two longitudinally extending sides 40. As shown in Figures 2 and 3, the bend / apex 26 of the first proximal seal stent 22 is preferably attached to the tubular graft body 12 by one or more seams 42 at each of the apex. However, other sewing methods are also possible. A suitable method and seam configuration for sewing the apex to the stent graft is disclosed and described in Hartley et al. (Patent Document 2) ("Stent-Graft Fastening"), published on July 3, 2007, the disclosure of which is incorporated herein by reference in whole.

[0020] As further shown in Figures 1-3, the fenestration 44, which will be described in more detail below, is located in the lateral wall 14. As shown in Figures 2 and 3, the internal branch 46 (Figures 2 and 3) is located within the lumen and extends from the fenestration toward the end of the stent graft. In Figures 2 and 3, the branch is shown to extend distally. However, branches extending proximal are also possible. The fenestration 44 and the internal branch 46 are configured and designed to receive arterial branches from the aortic arch (such as the left subclavian artery (LSA)). The fenestration 44 may be constructed together with a trough. Appropriate trough structures and methods for their fabrication are disclosed and described in Patent Document 3 ("Prosthesis With Side Branch and Method of Making") to Roeder et al., published on September 20, 2022, and in Patent Document 4 ("Prosthesis With Branched Portion") to Kratzberg et al., published on January 21, 2020, the entirety of which disclosures are incorporated herein by reference.

[0021] Figures 2 and 3 show a front and side view of the full-length prosthesis 10 shown in Figure 1. As shown, in addition to the first proximal seal stent 22, a series of additional stents are positioned distal to the first proximal seal stent and include a nested stent 48, a stent 50 supporting the opening, an auxiliary stent 52, a main stent 54, and a distal end seal stent 23, which will be further described below. The stents are distributed longitudinally along the graft body 12. Each stent includes multiple peaks and valleys connected in a zigzag arrangement to form a ring around the tubular graft body 12, either inside or outside the tubular graft body 12 or within the graft body 12 itself, with adjacent peaks and valleys (apexes) connected by struts. The term “peak” will generally be understood to refer to one set of apices (proximal or distal), and the term “valley” to refer to the other set of apices. In the embodiments described, the term “peak” is used for the proximal apex and the term “valley” is used for the distal apex; however, it will be recognized that in other embodiments, these terms may be used in reverse. In the illustrated embodiments, each stent is a self-expanding stent, some of which are made of stainless steel and some of which are made of nitinol. However, other materials or shapes of stents may also be used. For example, in other embodiments, any of the stents may be made of stainless steel or a shape memory alloy such as nitinol. In some embodiments, the stents may be expandable into a balloon shape. Other embodiments of prosthesis 10 may include any combination of stents from the group of stents. It will be recognized that any of the described stents may be positioned outside, inside, or within the graft material of a stent graft.

[0022] The stent is secured to the tubular graft body 12 by stitches / seams in any known manner, for example, as shown in Figure 1, the stent is attached at the tip. Alternatively or additionally, the stent may be attached to the tubular graft body completely or partially along the length of the strut by individual seams, continuous seams, etc. The stitches may be made from braided polyester and monofilament. In other embodiments, any other suitable form of attachment or stitching material may be used on any of the stents.

[0023] As shown, the scallop 32 is located at the proximal end 18 of the tubular graft body 12, as shown in Figures 1, 2, and 3. The scallop 32 is a cutout or notch in the material of the tubular graft body 12. The scallop 32 is sized and shaped so that when the prosthesis 10 is deployed in a target area within a human blood vessel, the scallop 32 receives the opening of an adjacent branch vessel. That is, the scallop 32 is sized and shaped such that its edge forms a seal around the opening of a branch vessel without occluding the opening of the branch vessel with the graft material. In this embodiment, when the prosthesis 10 is fully deployed within the patient's aortic arch, the graft material of the lateral edge 38 of the scallop 32 is adjacent to, for example, the opening of the left common carotid artery. When fully deployed, the distal end of the scallop 32 is positioned between the openings of the left subclavian artery (LSA) and the left common carotid artery (LCC), as shown in Figures 6 and 7. In this embodiment, the scallop 32 tapers in width from its maximum width at the proximal end to its minimum width at the distal end.

[0024] As shown in Figures 1-3, the transverse or lateral edge 38 of the distal end of the scallop 32 is substantially parallel to the edge of the graft material at the distal end 20 of the tubular graft body 12. In other embodiments, it may be more curved or angled than shown. In some embodiments, the scallop 32 may be formed with a single curve. In some embodiments, the scallop 32 may be horseshoe-shaped. Suitable shapes of scallops are disclosed and described in (Patent Document 1) ("Fenestrated Stent Grafts") to Hartley et al., published January 10, 2017, the disclosures of which are incorporated herein by reference in their entirety.

[0025] The dimensions of the scallop 32 can be adjusted according to the target vessel. As shown in Figure 2, the scallop 32 has a maximum width of 30 mm at its proximal end and a minimum width of 25 mm at its distal end. In this embodiment, the scallop 32 has a depth of 14 mm from distal to proximal end, and the proximal end of the scallop 32 is at the proximal end 18 of the tubular graft body 12, as shown in Figure 3. In other embodiments, the width and depth of the scallop 32 can be any appropriate size to accommodate the opening of the target vessel. With respect to a prosthesis intended to be deployed in the aortic arch, the scallop 32 is preferably configured to allow a proximal seal zone of 10–20 mm, the proximal seal zone being the zone between the scallop 32 and the nearest opening, such as the fenestration 44, which will be detailed below. A first proximal seal stent 22 at the level of the scallop 32 provides some seal, but the proximal seal zone provides the majority of the seal. The size of the seal zone can be varied to be appropriate for the distance between the patient's vessels. The sealing zone is preferably at least 10 mm, more preferably at least 15 mm. In this embodiment, the sealing zone is 16 mm.

[0026] Referring again to Figure 1, at the proximal end 18 of the prosthesis 10, the graft material forms a proximal margin 56, which extends around the tubular graft body 12. The scallop 32 defines first and second peripheral regions 58, 60 at the proximal end 18. The first peripheral region 58 coincides with and is in the same range as the scallop 32, and the second peripheral region 60 constitutes the rest of the perimeter, so that the first and second peripheral regions constitute the complete perimeter of the prosthesis. The first peripheral region 58 is smaller than the second peripheral region 60, i.e., the second peripheral region 60 constitutes the majority of the perimeter of the graft at the proximal end 18.

[0027] The first proximal seal stent 22 of the prosthesis 10 is the outermost stent located at the proximal end 18 of the tubular graft body 12. As described above, the apex 26 of the first proximal seal stent 22 includes a set of proximal apex 28 and a set of distal apex 30, as shown in Figure 4. The set of proximal apex 28 includes a scalloped apex 36 located in the first peripheral region 58 (in other words, on the scallop 32) and a body apex 34 located in the first peripheral region 60 (in other words, circumferentially outside the scallop 32).

[0028] The first proximal seal stent 22 can therefore be said to include a plurality of stent units, each stent unit including first and second struts 24 connected by a proximal apex 26. Adjacent stent units are connected by a distal apex 30 to form a stent ring. The plurality of stent units include scallop units and body units, each scallop unit having a proximal apex located in the scallop (in the first periphery region 58), and each body unit having a proximal apex located in the second periphery region 60. Each scallop unit includes a pair of struts 24 connected by a scallop apex 36. Similarly, each body unit includes a pair of struts 24 connected by a body apex 34. Body units adjacent to the scallop that support the scallop, in particular supporting the lateral portion of the scallop 32, are called support units 39. The struts of the support units 39 adjacent to the scallop extend along the edge of the scallop (see Figure 2). The support units 39 are positioned on each side of the scallop 32.

[0029] As shown in the figure, the first proximal seal stent 22 is an internal stent, in other words, it is positioned around the inner surface of the tubular graft body 12. However, it can also be an external stent, i.e., it can be positioned within the thickness of the graft material. The first proximal seal stent 22 may have 16 to 28 apex 26, of which 8 to 14 are proximal apex 28 and 8 to 14 are distal apex 30, but in practice this can vary depending, for example, on the diameter of the prosthesis. Thus, any appropriate number of apex 26 can be present. It is preferable, but not required, to have the same number of proximal apex 28 and distal apex 30. Similarly, of the 14 proximal apex 28 in the shown embodiment, there are 3 scalloped apex 36 and 11 body apex 34. However, the number of scalloped apex may vary based on the size of the scallop. In other embodiments, there may be any number of scalloped tips 36 and any number of body tips 34, but it is assumed that the scalloped tips may be located in the first peripheral region, i.e., the scallop 32. However, it is preferable that there be more body tips 34 than scalloped tips 36.

[0030] All of the body tips 34 are positioned on the proximal edge 56 of the graft material, as best shown in Figure 1. All body tips 34 are positioned on the proximal edge 56 of the graft material to most efficiently seal the proximal end 18 of the tubular graft body 12. However, in other embodiments, the body tips 34 can be positioned further distal or proximal than shown in various ways.

[0031] The scallop tip 36 is positioned distal to the main body tip 34 adjacent to the scallop 32. In particular, it has been found beneficial that the scallop tip 36 does not extend to the nearest end of the tubular graft body 12. This arrangement reduces the stent struts and tip within the scallop 32 that could normally collide with the vessel wall at the location of a branch vessel, thereby reducing the possibility of trauma or damage to the vessel. In this embodiment, the first proximal seal stent 22 can be said to include a scallop at its proximal end in the region of the scallop 32 of the tubular graft body 12.

[0032] The set of distal apex 30s are all positioned distal to the distal end 20 of the scallop 32, particularly its most distal edge, as can be seen in Figures 2, 3, and 4. Preferably, all or at least a large portion of the distal apex 30s are positioned at least longitudinally at the same level as or distal to the distal end of the scallop 32 or the most distal point on the scallop 32, thereby improving the ability of the first proximal seal stent 22 to seal the entire periphery of the scallop 32. As shown in Figure 2, the distal apex 30s are all also aligned with each other. As shown in Figure 3, the longitudinal position of the distal apex 30s may vary along the periphery of the tubular graft body 12. In particular, the distal apex 30s are most distal to the medial curvature region 62 (shown in Figure 6) of the prosthesis 10, which is a region configured to unfold medially into the curvature of the body cavity. The distal apex 30 becomes more linearly proximal in both circumferential directions away from the medial curvature region 62, and as a result, they are most proximal on the side opposite the diametrically opposed side of the medial curvature region 62. In this way, the distal apex forms an ellipse lying in a plane not perpendicular to the longitudinal axis of the prosthesis. In other embodiments, the distal apex 30 may all be of the same height in the longitudinal direction. Furthermore, in other embodiments, the distal apex may be non-aligned.

[0033] The scallop tip 36 is located at the distal end of the scallop 32. Referring again to Figures 1 and 4, the main body tip 34 is entirely covered, i.e., overlapped, by the graft material. However, the scallop tip 36 extends proximal to the proximal edge 16 of the tubular graft body 12 in the scallop 32, in other words, proximal to the distal end of the scallop, and is not covered by the graft material. As a result, most, though not all, of the first proximal seal stent 22 is covered by the graft material. Nevertheless, the graft covers at least most of each of the gaps between the peaks of the first proximal seal stent 22. In other words, the spaces between the struts 24 that suffocate to the adjacent proximal tips 28 of the first proximal seal stent 22 are substantially or completely overlapped by the graft material.

[0034] However, as shown in Figures 13-16, the proximal tip 28 of the first proximal seal stent 22 does not extend beyond the graft material (i.e., the proximal stent can be completely covered by the graft material). This may be the case, for example, when the proximal stent is made of nitinol. However, integrating a scalloped tip 36 that extends beyond the graft material has been found to be beneficial in some embodiments, such as the embodiment in Figure 1, for reasons that will be explained later.

[0035] As described, the apex 28 of the first proximal seal stent 22 is connected by a strut 24. Each of the scalloped apex 36 is connected to the adjacent distal apex 30 by first and second scalloped apex struts 64. Similarly, each of the body apex 34 is connected to the adjacent distal apex 30 by first and second apex struts 66.

[0036] As best illustrated in Figure 4, the struts 24 may vary in length along the periphery of the first proximal seal stent 22, forming longer and shorter segments of the stent. In particular, the struts 64 at the scallop 32 are shorter on each side than the struts 66 adjacent to the scallop 32. In other words, the first and second struts 64 of each scallop unit are shorter than the first and second struts of each support unit 39. The shorter scallop apex struts 64 reduce the volume of stent material at the scallop 32, keeping the scallop substantially clear. At the same time, the longer struts 66 of the support unit 39 help support and seal the prosthesis adjacent to the scallop.

[0037] The scallop apex strut 64 is preferably short to avoid obstructing the scallop 32 over as wide an area as possible. However, in practice, it has been found beneficial to use a minimum strut length to achieve improved stent flexibility and elasticity and to avoid undesirable plastic deformation during use, particularly in the region of branched vessels. The minimum strut length depends on the dimensions of the target vessel and the material of the strut. In some embodiments, such as the embodiment in Figure 1, the minimum strut length results in a scallop apex 36 extending beyond the graft material, as shown in Figure 1. Nevertheless, at least a large portion of each scallop unit is overlapped by the graft material. Furthermore, it should be recognized that, as shown above, the extension of the scallop apex beyond the graft material is not essential in all embodiments. In some embodiments, for example, when the proximal stent is made of nitinol, the minimum strut length is such that the scallop apex 36 is positioned distal to the proximal edge 16 and the distal end of the scallop, thereby allowing it to be covered by the graft material. In the embodiment shown, the strut length of the scallop unit is 17 mm.

[0038] In the embodiments shown in Figures 1-7, the scalloped tip struts 64 are shorter than most of the body tip struts 66. In other embodiments, all scalloped tip struts 64 are shorter than any of the body tip struts 66. However, it is particularly beneficial that the scalloped tip struts 64 are shorter than the body tip struts 66 adjacent to the scallop 32 (in other words, those within the support unit 39 as described above). In some embodiments, the scalloped tip struts 64 are shorter than the pair of body tip struts 66 adjacent to the scallop. In other words, it is particularly beneficial that the first and second struts of the scallop unit are shorter than the first and second struts of the support unit 39. In the embodiments shown, all scalloped tip struts 64 are the same length, but in other embodiments, they may be of different lengths.

[0039] The apex 28 does not have to be uniform along the periphery of the first proximal seal stent 22. Stents typically have apexes with a consistent radius of curvature along their periphery, thereby generating a uniform radial force around the stent. However, the first proximal seal stent 22 may have apexes 28 with different radii of curvature along its periphery. In particular, the first proximal seal stent 22 may include at least one scallop unit having a proximal apex that is more rounded or has a larger radius of curvature than the proximal apex of at least one preferably substantially diametrically opposed body unit. For example, all scallop apexes 36 have a larger radius of curvature than each of the body apexes 34. The increased roundness of the scallop apexes 36 better distributes and blunts the radial forces exerted by the stent at those apexes, reducing the pressure / area on the vessel and thereby reducing the potential trauma or erosion effect of the scallop apexes 36 on the tissue of the vessel wall. This may also assist in seal formation.

[0040] The scalloped apex 36 may be more rounded than all other apex 26 of the first proximal seal stent 22. The less rounded body apex 34 and distal apex 30 relatively reduce the volume of the first proximal seal stent 22 and increase its elasticity. This effect is particularly beneficial in the region of the stent 22 opposite the circumferential direction of the scallop 32, which is located inside the curvature of the vessel during use. In this embodiment, the distal set of apexes all have the same radius of curvature. Furthermore, in this embodiment, all apexes of the stent located in the second periphery region have the same radius of curvature.

[0041] As shown in Figures 1-7, each of the scalloped tips 36 has a radius of curvature of 1 mm, each of the body tips 34 has a radius of curvature of 0.5 mm, and each of the distal tips 30 has a radius of curvature of 0.5 mm. It has been found to be particularly advantageous for the scalloped tips 36 to have a radius of curvature approximately twice that of the body tips 34. In some embodiments, the scalloped tips may have a radius of curvature of 1.5 to 2.5 times that of the body tips 34. It has been found to be far more advantageous for the scalloped tips 36 to have a radius of curvature approximately twice that of all the remaining tips 28 (i.e., the body tips 34 and the distal tips 30). In other examples, the scalloped tips may have a radius of curvature of 1.5 to 2.5 times that of the remaining tips. Note that not all of the scalloped tips 36 need to have the same radius of curvature in every embodiment. Similarly, not all of the body tips 34 need to have the same radius of curvature as one another. Similarly, the distal apex 30 does not necessarily have to have the same radius of curvature in all embodiments.

[0042] The first proximal seal stent 22 may have a proximal-distal length from the proximal end to the distal end of the stent 20, which varies along the circumference of the prosthesis 10, as shown in Figure 3. In particular, the length of the proximal stent increases in both circumferential directions from the inner curved region 18 of the prosthesis 10, giving the first proximal seal stent 22 a wedge shape.

[0043] Furthermore, as shown in Figures 3 and 12, the proximal end of the first proximal seal stent 22 is tapered, and as a result, the longitudinal position of the first end of the stent increases in both circumferential directions from the inner curvature region in the proximal-distal direction. In particular, the longitudinal position of the first end of the stent becomes more proximal in both circumferential directions from the inner curvature region. The taper is away from the scallop 32. Furthermore, in this embodiment, the proximal end of the graft body (substantially the plane of the end of the graft body) is inclined with respect to the side wall 14 (and the longitudinal axis of the graft body), thereby forming an obtuse angle with respect to the side wall 14 in the inner curvature region at the proximal end of the graft body. In this embodiment, the proximal end of the tubular graft body 12 aligns with the proximal end of the first proximal seal stent 22 along at least a large portion of the periphery of the proximal end of the tubular graft body 12, and in this embodiment along the entire proximal end of the tubular graft body 12 excluding the scallop 32. In particular, the proximal end of the tubular graft body 12 is substantially equidistant from the proximal end of the first proximal seal stent 22 along at least a large portion of the periphery of the proximal end of the tubular graft body 12, and in this embodiment along the entire proximal end of the tubular graft body 12 excluding the scallop 32. The majority of the proximal end 18 of the tubular graft body 12 lies in a plane that is generally parallel to the plane in which the body tip 34 is located. In particular, as described above, in this embodiment, the entire body tip 34 is on the proximal edge 56 of the graft material, and in particular about 1 mm from the edge 56. The tip of the main body may be slightly further spaced from the proximal edge of the graft material, but preferably all of it is within 2 mm of the proximal edge of the graft material.

[0044] More specifically, within the strut 24, the body apex struts 66 vary in length along the periphery of the first proximal seal stent 22, as shown in Figure 3. In this embodiment, pairs of body apex struts 66 closer to the scallop 32 may be longer than those further away from the scallop 32, and a pair of body apex struts 66 is two body apex struts 66 that merge at a common proximal apex 28, also called a stent unit. The length of each pair of body apex struts 66 varies linearly so that the body apex 34 is aligned in a straight line. The body apex 34 closest to the scallop 32 extends further proximal to the opposite side of the scallop 32 in the circumferential direction, forming a taper as shown in Figure 3 as offset A. Figure 3 shows the tapered profile and wedge shape of the prosthesis 10 when viewed in profile. The proximal end 18 of the tubular graft body 12 is also tapered in the first periphery region 58 according to the same profile and taper. The length of the main apical strut 66 changes in equal increments on both sides of the scallop 32, thereby making the first proximal seal stent 22 symmetrical.

[0045] As can be seen in Figure 3, in this embodiment, the taper of the proximal end 18 of the first proximal seal stent 22 includes body apex 34 located at proximal positions that are offset from each other in the proximal-distal direction and increase in the circumferential direction from the inner curvature region 62. In this embodiment, all body apex 34 contribute to the taper, whereas in other embodiments, one or more body apex 34 may be out of line while still maintaining the overall taper. The taper preferably includes at least three preferably adjacent apex of the first end of the first stent, offset from each other in the circumferential direction from the inner curvature region in the embodiment described. The offsets between adjacent body apex 34 are substantially the same and form a linear taper. In this embodiment, the taper, i.e. offset A, is 15 mm, which has been shown to provide optimal performance. Preferably, the taper is about 5 mm to about 20 mm, more preferably about 10 mm to about 20 mm, and most preferably about 13 mm to about 17 mm.

[0046] In stent-grafts with stents having struts of uniform length along their periphery, adjacent stents may interfere with each other in curved sections of the vessel. When such stent-grafts are deployed in tortuous vessels, the stent-graft is more likely to sit around the vessel wall, extending tangentially from the curve of the vessel, resulting in an incomplete seal and poor alignment within the vessel.

[0047] In contrast, the wedge shape of the first proximal seal stent 22 corresponds to the curvature of the prosthesis 10 when positioned within a curved vessel such as the aortic arch. In its deployed state, the prosthesis 10 is oriented within the vessel such that the narrowed end of the wedge shape is located inside the curvature of the vessel. The wedge shape and taper are configured such that, when the prosthesis 10 is deployed, the line formed by the body apex 34, as well as the proximal end of the graft body, and especially the proximal edge 16 of the tubular graft body 12 within the first peripheral region 58, is deployed substantially perpendicular to the curvature of the vessel, as shown in Figure 7. In this way, the first proximal seal stent 22 of the prosthesis 10 exerts force on the vessel wall at an optimal angle, allowing the graft material of the prosthesis 10 to seal tightly against the vessel wall.

[0048] As shown, the first proximal seal stent 22 has a body apical strut 54 whose length varies from 19 mm at the pair of struts (or stent unit) circumferentially opposite the scallop 32 to 27 mm at the pair of struts (or stent unit) closest to the scallop 32, with the length of each pair of body apical struts 54 increasing by a 2 mm increment for each consecutive body apex 34. The length of the body apical struts 54, which form a wedge shape, can be adjusted according to the expected length of the attachment area and the optimal taper angle relative to the vascular shape.

[0049] Figures 8, 9, and 10 show further embodiments of the first proximal seal stent 22. Here, the first proximal seal stent 22 is identical in all aspects to the first proximal seal stent 22 of Figures 1-7, except for the length of its struts 26. Figure 8 shows the variation in the length of the struts 26 along the periphery of the first proximal seal stent 22. In this embodiment, the body apex struts 66 of the first proximal seal stent 22 taper in length from 22 mm at the pair of struts (or stent unit) closest to the scallop apex 36 to 17 mm at the pair of struts (or stent unit) furthest from the scallop apex 36, and the length of consecutive pairs of body apex struts 66 changes in increments of 1 mm for each body apex 34. The body apex 34 is positioned along line 68, and the distal apex 30 is positioned along line 70. This forms the wedge-shaped profile of the stent 22 as shown in Figure 9. Compared to the first proximal seal stent 22 in Figures 1-7, the proximal end of the stent in this embodiment can provide a shallower taper or offset A in the wedge shape of the stent 22. Figure 10 shows a further embodiment of the first proximal seal stent 22 positioned at the proximal end of the prosthesis 10. In all other aspects, the prosthesis 10 in Figure 10 is the same as that in Figures 1-7. Other embodiments of the stent 22 may have a body apical strut 66 of any length suitable for the target vessel.

[0050] The length variation between the main body struts 66 may be non-linear. Furthermore, portions of the main body tip 34 may be positioned in various ways further proximal or distal, and / or portions of the main body tip struts 66 may be shorter or longer than the described arrangement, while still providing a generally wedge-shaped stent and taper. It has been found to be particularly advantageous for the outermost stent to utilize a wedge shape on the proximal side of the prosthesis 10. However, any of the other stents of the prosthesis 10 may similarly or alternatively have a wedge shape.

[0051] It should be recognized that some of the advantages provided by the features of the first proximal seal stent 22 can be achieved independently of any or all of the other components of the prosthesis 10, for example, without the scallop 32 and the fenestration 44.

[0052] Similarly, it should be recognized that some advantages provided by the change in the roundness of the apex 26 of the first proximal seal stent 22 can be achieved without a change in the length of the strut 24 of the first proximal seal stent 22. On the other hand, some advantages achieved by a change in the length of the strut 24 can be achieved without a change in the roundness of the apex 26. Similarly, some advantages achieved by the difference in length between the scalloped apex strut 64 and the body apex strut 66 can be achieved without a change in the length between the body apex struts 66. Similarly, some advantages achieved by the wedge shape of the first proximal seal stent 22 can be achieved without the scalloped apex strut 64 or the scalloped apex 36.

[0053] Referring to Figures 2, 3, and 4, the prosthesis also includes a nested (or sealed) stent 48 positioned distal to and adjacent to the first proximal sealed stent 22. As shown in Figure 4, the nested stent 48 has a set of proximal apex 72 and a set of distal apex 74 connected by struts 76. The struts 76 and apex 72, 74 form a series of peaks and valleys. In contrast to the first proximal sealed stent 22, the nested stent 48 is radially symmetrical. In particular, in the shown embodiment, the nested stent 48 has struts 74 of uniform length and apex 72, 74 having a uniform radius of curvature along its circumference. In this embodiment, in contrast to the other stents of the prosthesis 10, the nested stent 48 is made of nitinol. However, as described above, in other embodiments, the nested stent 48 can be made of stainless steel or any other suitable stent material. Furthermore, since the nested stent 48 in this particular embodiment is made of nitinol, it can also be made with a thinner wire gauge than the stainless steel of the first proximal seal stent 22, although this is not essential in all embodiments.

[0054] The proximal apex 72 of the nesting stent 48 is positioned so that each peak of the nesting stent 48 is nested between each pair of valleys of the first proximal seal stent 22 (in other words, between adjacent pairs of distal apex 30). In this way, the nesting stent 48 can provide improved flexibility and better control of radial forces, and can improve sealing in the proximal portion of the prosthesis 10, for example by reducing graft invagination. This may allow the use of the first proximal seal stent 22 with a smaller apex, which may be better for the patient. The nesting stent 48 can also enable better control of the deployment of the prosthesis 10 and may facilitate the maintenance of its structure after the prosthesis 10 has been crimped within the sheath for delivery.

[0055] In other embodiments, only a portion of the proximal apex 72 of the nesting stent 48 is nested between the distal apex 30s of the first proximal seal stent 22, but preferably at least the majority of the proximal apex is nested between the distal apexes of the first proximal seal stent 22, and the nesting arrangement is preferably radially symmetrical, as in the embodiment of Figure 1. Similarly, in some embodiments, two or more proximal apex 72s of the nesting stent 48 can be nested between the same pairs of distal apex 30s of the first proximal seal stent 22. However, it has been found to be particularly advantageous when each of the proximal apex 72s is nested between the respective pairs of distal apex 30s of the first proximal seal stent 22.

[0056] The struts 76 of the nesting stent 48 are shorter than the struts 24 of the first proximal seal stent 22. In this embodiment, all the struts of the nesting stent 48 are shorter than all the struts of the first proximal seal stent 22. In other embodiments, it is not necessary for all the struts of the nesting stent 48 to be shorter than all the struts of the first proximal seal stent 22, but preferably at least a large portion of the struts of the nesting stent are shorter than the first struts of the first proximal seal stent 22, preferably the body tip struts.

[0057] As described above, in the embodiment shown, the nesting stent 48 is made of nitinol and the first proximal seal stent 22 is made of stainless steel. As a result, the nesting stent 48 in this particular embodiment generates generally lower radial forces than the first proximal seal stent 22. However, in other embodiments, either or both of the nesting stent 48 and the first proximal seal stent 22 can be made of stainless steel, nitinol, or any other suitable stent material.

[0058] It should be noted that any other stent of prosthesis 10 can be similarly or alternatively arranged in a nested configuration. In particular, several advantages provided by the nested configuration can be achieved without the characteristics of the first proximal seal stent 22, such as variations in the curvature of the apex 26 or variations in the length of the struts 24. For example, a regularly zigzag shaped stent placed at any position within the graft can also be configured in the same nested stent and nested arrangement as described above. This nested arrangement is particularly advantageous for stents that have a sealing function (i.e., stents that act to seal the graft material against the vessel wall).

[0059] As shown in the figure, the tubular graft body 12 also includes an opening 44. As shown in Figures 1 and 10, the opening 44 is circumferentially aligned with the scallop 32 and distal to the scallop 32. The opening 44 is sized and positioned to accommodate the opening of a branch vessel when the prosthesis 10 is fully deployed. In the shown embodiment, the prosthesis 10 is designed to deploy in the aortic arch, at which point the opening 44 aligns with the opening of the left subclavian artery.

[0060] In particular, in the aortic arch, the available landing zone for a stent-graft is challengingly small. Specifically, the distance between the left subclavian artery and the left common carotid artery, and therefore the available distance between the scallop 32 and the fenestration 44, is very short. In the embodiments shown in Figures 1-7, the length between the scallop 32 and the fenestration 44 is 16 mm. In other embodiments, the length between the scallop 32 and the fenestration 44 may be any value appropriate to correspond to the distance between the openings of adjacent branches within the target vessel. As described above, with respect to embodiments intended to be deployed in the aortic arch, the scallop 32 is preferably configured to allow a proximal seal zone of 10-20 mm.

[0061] The shape of the opening 44 is triangular or triangular (in other words, substantially triangular). In this embodiment, the opening 44 is similar to a triangle with rounded corners and is formed by three substantially straight edges or sides 78, 80, 82 joined by three rounded corners 84, 86, 88. The opening 44 is oriented to have a apical proximal side 66 aligned laterally with respect to the longitudinal axis of the tubular graft body 12 (extending between the proximal end 18 and the distal end 20). The proximal side 80 includes at least a portion substantially perpendicular to the longitudinal axis of the tubular graft body 12. The proximal side 80 connects the proximal ends of the two remaining sides 78, 82 which converge at the distal apex at the distal end 63 of the opening 44. The flat top of the fenestration 44 formed by the proximal side 80 allows for positioning a larger portion of the fenestration area closer to the scallop 32 than, for example, in the case of a circular or elliptical fenestration. The U-shape formed by the converging sides 78, 82 also functions as a funnel or guide to facilitate positioning the introducer assembly within the fenestration 44 for lateral branch cannula insertion. Suitable fenestration structures and methods for fabricating them are disclosed and described in (Patent Document 3) ("Prosthesis With Side Branch and Method of Making") to Roeder et al., published September 20, 2022, and in (Patent Document 4) ("Prosthesis With Branched Portion") to Kratzberg et al., published January 21, 2020, the contents of which are incorporated herein by reference in their entirety. The proximal side 80 may present an unoccluded pathway that is not at least partially occluded by stent placement and / or suturing.

[0062] In some embodiments, the tubular graft body 12 may include an opening 44 but not a scallop 32. In other embodiments, the tubular graft body 12 may include a scallop 32 but not an opening 44.

[0063] The nesting stent 48 is provided adjacent to the proximal edge 80 of the fenestration 44. In practice, it is positioned proximal to the fenestration 44, with the distal tip 74 of the nesting stent 48 positioned adjacent to the proximal edge 80 of the fenestration 44. Similar to the scalloped tip 36, it is preferable that the distal tip 74 is positioned adjacent to the edge of the graft material without extending beyond or into the fenestration 44, maximizing the use of the available limited seal zone and maximizing the seal of this seal zone without occluding the opening of the branch vessel with the stent material. Therefore, in the preferred embodiment shown, the distal tip 74 does not extend beyond the graft material at the proximal edge 80 of the fenestration 44. On the other hand, the proximal edge 80 of the fenestration 44 does not extend proximal to the distal tip 74 of the nesting stent 48.

[0064] The prosthesis 10 includes an internal branch graft 46, as faintly shown in Figures 2 and 3 and highlighted in Figures 11 and 12 (which show a second embodiment of the prosthesis 10 of Figure 10, the graft 10 having a shallower taper at the proximal end 18 compared to the first embodiment in Figures 1-7, but otherwise identical). The branch graft 46 extends distally from the opening 44 inside the tubular graft body 12. In other words, the internal branch graft 46 extends distally from the opening within the lumen 16 of the stent graft. The branch graft 46 is generally tubular and includes an internal lumen that communicates with the opening 44 and the internal lumen 16 of the tubular graft body 12. In this embodiment, the branch graft 46 is made of a polyester woven fabric, but in other embodiments, it can be made of any suitable flexible and biocompatible material. The internal branch graft 46 is provided to assist in guiding the catheter between the internal lumen 16 of the tubular graft body 12 and the branch vessel adjacent to the fenestration 44. During use, a cannula and / or dilation graft can be introduced through either the proximal or distal end of the internal branch graft 46 to deploy the dilation graft into the branch vessel adjacent to the fenestration. For example, a cannula carrying the dilation graft can be introduced from the subclavian artery and then introduced into the internal branch graft 46 through the fenestration and the proximal end of the internal branch graft. The dilation graft can then be deployed from the internal branch graft 46 across the branch vessel. In another embodiment, a cannula carrying the dilation graft can be introduced from the distal end of the internal branch graft and then introduced into the branch vessel through the proximal end of the internal branch graft. The dilation graft can then be deployed from the internal branch graft 46 across the branch vessel.

[0065] Internal branch grafts may be linear, curved, or helical. Preferred internal branchings are disclosed and described in (Patent Document 3) ("Prosthesis With Side Branch and Method of Making") to Roeder et al., published September 20, 2022, and in (Patent Document 4) ("Prosthesis With Branched Portion") to Kratzberg et al., published January 21, 2020, the disclosures of which are incorporated herein by reference in their entirety.

[0066] In this embodiment, the internal branch graft 46 has two distinct portions, namely a proximal portion 90 and a distal portion 92. The proximal portion 90 has a proximal longitudinal axis, and the distal portion 92 has a distal longitudinal axis. The proximal longitudinal axis of the proximal portion 90 intersects the longitudinal axis of the stent graft at an acute angle, and the distal longitudinal axis of the distal portion 92 intersects the longitudinal axis of the stent graft at an acute angle. The acute angle between the distal longitudinal axis and the longitudinal axis of the stent graft is smaller than the acute angle between the proximal longitudinal axis and the longitudinal axis of the stent graft. This results in the formation of a dogleg or elbow in the internal branch graft 46, as is best seen in Figure 12.

[0067] By providing a proximal portion 90 and a distal portion 92 of the internal branch graft 46 having a larger and smaller acute angle, respectively, a smooth transition is provided between the angle of the left subclavian artery and the angle of the longitudinal axis of the stent graft. Extending the internal branch graft 46 distally within the lumen 16 of the stent graft makes cannula insertion through the left subclavian artery easier. However, having a transitional proximal portion of the internal branch graft 46 avoids a sharp 90-degree angle between the axis of the left subclavian artery and the axis of the stent graft. This helps to avoid twisting of devices such as stents introduced into the left subclavian artery.

[0068] In this embodiment, the entire internal branch graft 46 is angled obliquely so that it extends laterally from the window 44 as it extends distally within the internal lumen 16, as can be seen in Figure 11. This angle or twist of the internal branch graft 46 further contributes to providing a simpler pathway and reducing the possibility of torsion of the small stent being introduced, for example, into an artery. The angle of twist is preferably 5 to 45 degrees with respect to the central longitudinal axis of the tubular graft body 12, when measured from the longitudinal axis of the distal portion 92 of the branch graft. In this embodiment, the angle of twist is 16 degrees.

[0069] The proximal and distal portions 90 and 92 of the internal branch graft 46 also differ in their proportions. The distal portion 92 is cylindrical and relatively elongated and slender, while the proximal portion 90 is generally frustoconical and tapered from a larger diameter at its proximal end (where it merges with the fenestration 44) to a smaller diameter at its distal end (which matches the diameter of the distal portion 92). The shape of the proximal portion 90 assists the clinician when accessing the internal branch graft 46 with a cannula and / or dilation graft, while the shape of the distal portion 92 helps guide the cannula and / or dilation graft more accurately into the target artery. In this embodiment, the proximal portion 90 and distal portion 92 are the same length (measured along their respective longitudinal axes from the proximal end to the distal end), but their lengths are not particularly limited, and the proximal portion 90 and distal portion 92 do not need to be the same length.

[0070] In this embodiment, the distal portion 92 of the internal branch graft 46 includes a support structure that facilitates the maintenance of its shape and patency. The support structure may be implemented in known ways and may include a proximal D-ring 94, a distal O-ring 96, and a pair of opposing struts 98 connecting the O-ring and D-ring along the longitudinal axis of the distal portion 92. The support structure in this embodiment is made of nitinol. Other embodiments may have any suitable support structure. A suitable support structure for branching is disclosed and described in (Patent Document 5) ("Side branch stent graft construction") to Hartley et al., published March 29, 2011, the disclosure of which is incorporated herein by reference in whole. An additional suitable support structure including radiopaque markers is disclosed and described in (Patent Document 6) ("Radiopaque Markers on Medical Device") to Kim et al., the disclosure of which is incorporated herein by reference in whole. Branching without a support structure is also conceivable.

[0071] As shown in the figure, the window 44 may be a single window 44 of the tubular graft body 12 and a single branched graft 46. In other embodiments, any number of windows and branched grafts may be present. In some embodiments, neither windows nor branched grafts may be present. In some embodiments, the prosthesis may include windows but not branched grafts.

[0072] The prosthesis 10 also includes a window 44 and a window-supporting stent 50 aligned longitudinally. The window-supporting stent 50 has a plurality of proximal apexes 51 and a plurality of distal apexes 53, and the proximal and distal apexes are connected to each other by a plurality of stent struts 55 extending between them, as shown in Figures 2, 3, 5, 11, and 12. The window 44 is provided between two struts 55 of the window-supporting stent 50, and the combination of the two struts 55 and the distal apex 53 of the window-supporting stent 50 defines two sides 78, 82 and a distal end 84 of the window.

[0073] As a result, the window-supporting stent 50 partially surrounds and supports the window 44. In particular, the distal apex 53 and two adjacent struts 55 of the window-supporting stent 50 form two sides 78, 82 and the distal apex of the distal end 84 of the triangular window 44. The pair of proximal apexes 53 of the window-supporting stent 50 coincide with the corners 86, 88 of the proximal end of the window 44. Note that in this embodiment there is no additional support on the proximal side 80. However, in other embodiments, it is not excluded that a support member may be provided across the proximal side 80 to further support the proximal side 80. In this embodiment, the window-supporting stent 50 is positioned inside the graft material, but in other embodiments it may be positioned outside.

[0074] The distal apex 53 of the fenestrated stent 50 has a larger radius of curvature than the proximal apex 51. In particular, the distal apex 53 has a radius of curvature that matches the curvature of the distal angle 84 of the triangular fenestration 44. In some embodiments, it is not necessary for the entire distal apex 53 to have a larger radius of curvature than the proximal apex 51, but at least the fenestrated support apex of the fenestrated stent ring is formed by a distal apex 53 having a larger radius of curvature than the proximal apex 51 of the fenestrated stent 50. In this embodiment, the distal apex 53 has a radius of curvature of 3.75 mm and the proximal apex 76 has a radius of curvature of 0.75 mm. Other embodiments may have different radii of curvature. A preferred range is 2 mm to 4.5 mm for the distal apex and 0.5 mm to 1.5 mm for the proximal apex.

[0075] The larger radius of curvature of the distal apex 53 of the fenestrated support stent 50 forms a larger fenestrated area, improving the stent 50's ability to accommodate the branched and expanded graft inserted therein without shrinking or obstructing the graft.

[0076] The prosthesis 10 also includes an auxiliary stent 52 located distal to the fenestrated support stent 50. The auxiliary stent 52 is a regularly zigzag shaped stent having a set of proximal apex 57 and a set of distal apex 59 connected by struts 61, as shown in Figure 5.

[0077] The prosthesis 10 also includes a series of external main stents 54 distributed along the distal portion of the tubular graft body 12 between the auxiliary stent 52 and the distal end 20. The main stents 54 are regularly zigzag shaped stents, and each stent has a set of proximal apex 63 and a set of distal apex 65 connected by struts 67, as shown in Figure 5. Unlike the other stents of the shown prosthesis 10, the main stents 54 are located outside the tubular graft body 12 in this embodiment, but in other embodiments they may be internal or located within the thickness of the graft material. The main stents 54 are equally spaced apart from each other and aligned with each other circumferentially, i.e., in phase. In the embodiments shown in Figures 2 and 3 and 5, there are four main stents 54, 23 positioned such that the distal apex 65 of one stent is offset 7 mm longitudinally from the proximal apex 63 of the next stent. In other embodiments, any number of main stents 54 may be present, and the spacing between them may be any appropriate distance. The most distal part of the main stent 54 is positioned at the distal end 20 of the tubular graft body 12 such that its distal tip 65 extends to the distal edge of the graft material.

[0078] In Figure 3, the proximal and distal sets (excluding the scalloped tip) of the first proximal seal stent 22, the nesting stent 48, and the window-supported stent 50 are each positioned in a plane angled from the vertical cross-section of the tubular graft body 12 (in other words, angled with respect to the distal end 20). As a result, as shown in Figure 3, when viewed in profile, an inclined alignment of the tip sets of each stent in the tubular graft body 12 is formed.

[0079] The set of body apex 34 of the first proximal seal stent 22 is positioned at a certain angle to the distal end 20, in particular, so that the apex 34 is aligned with an inclination that coincides with the tapered end of the tubular graft body 12. This further allows the prosthesis 10 to accommodate the curvature of the vessel, so that the first proximal seal stent 22 acts against the vessel wall at a desired angle within the curvature, thereby providing an improved seal. Due to the wedge shape of the first proximal seal stent 22 in this embodiment, the distal apex 30 is positioned at a relatively shallower angle than the angle of the body apex 34.

[0080] The proximal and distal sets of the apex 72 and 74 of the nesting stent 48 are positioned at an angle that matches the angle of the distal apex 30 of the first proximal seal stent 22. The proximal and distal sets of the apex 51 and 53 of the fenestrated support stent 50 are positioned at a relatively steeper angle than the angle of the apex of the nesting stent 48. This creates a larger gap between the fenestrated support stent 50 and the nesting stent 48 on the opposite side of the circumferential direction of the scallop (in other words, in the internal curvature region 62) than at the point closest to the scallop. This is beneficial for allowing the prosthesis to curve without interference between the stents in the internal curvature region.

[0081] It should be noted that the struts of a stent angled in this manner cannot be angled inward toward the lumen 16 (i.e., they remain tightly overlapping the side wall 14 of the tubular graft body 12). When optimal sealing is achieved, the internal lumen 16 of the prosthesis 10 aligns precisely with the blood vessel. In other embodiments of the prosthesis 10, any combination of stents can be angled in this manner. Some embodiments do not have a stent that is angled in this manner. As partially shown in Figures 6 and 7, the prosthesis 10 of the embodiments described is combined with an introducer 100 configured to deploy the prosthesis 10 into a curved lumen, thereby attaching the prosthesis to the introducer in a compressed state, so that the internal curved region 62 is positioned to deploy inside the curve of the lumen. The introducer 100 of these embodiments may include, but is not required, a pre-curved cannula (not shown). One suitable pre-curved cannula is disclosed and described in (Patent Document 7) to Kratzberg et al., published on December 1, 2015 ("Conformable prosthesis delivery system and method for deployment thereof"), the disclosure of which is incorporated herein by reference in whole. The wedge-shaped first proximal seal stent 22 is attached to the introducer so that the narrowed end of the wedge shape is positioned to extend inside the curvature of the vessel, thereby achieving precise orientation within the vessel.

[0082] Returning to Figures 1, 6, 7, and 10, the prosthesis 10 of the described embodiment also includes one or more fitting ties 43. The fitting ties 43 are circumferentially positioned around the first proximal seal stent 22 and are operable to contract the first proximal seal stent 22 radially relative to the introducer, and they are held by release wires (not shown) to keep this tightened configuration releaseable.

[0083] Appropriate compatible ties are disclosed and described in Schmidt et al. (Patent Document 8) and (Patent Document 9) ("Stent Graft"), the disclosures of which are incorporated as a whole by reference and described below.

[0084] Adapted tie 43 may include a loop arrangement to reduce the diameter around the distal end of the first proximal seal stent 22, resulting in an angled position or conical configuration of the proximal stent. The loop arrangement for reducing the diameter includes first and second loop elements.

[0085] The first loop element may include a first end and a second end, and a strand section between the first and second ends. The first loop element includes a loop at the second end. In the illustrated embodiment, the first loop element consists of a single strand extending from the first end to the second end, so that it loops back to the first end, thereby forming a loop at the second end. Thus, the first loop element includes a first strand section from the first end to the second end of the first loop element, and a second strand section from the second end to the first end of the first loop element. However, in other embodiments, the first loop element may include a loop at the second end, such that the strand section is not necessarily part of a single strand that loops back to the first end. For example, a strand may be tied to itself at a point between the first and second ends, for example, by a second strand section extending from the second end and being tied to the first strand section between the first and second ends of the first loop element.

[0086] The first end of the first loop element is attached to the distal end of the first proximal seal stent 22, which in this embodiment is the distal portion of the first proximal seal stent 22, but in other embodiments it may be attached to the tubular graft body 12. In the illustrated embodiment, the first end of the first loop element is tied to the first proximal seal stent 22 by a knot at the first distal apex 30 of the first proximal seal stent 22. Furthermore, in the illustrated embodiment, due to the fact that the strand of the first loop element loops back to the first end, both ends of the strand are tied to the first proximal seal stent 22 at the first distal apex 30 of the first proximal seal stent 22. In particular, the first end of the first loop element, and therefore both ends of the strand of the first loop element, are tied to the strut 40 of the first proximal seal stent 22 at the first distal apex 30.

[0087] The second loop element includes a first end and a second end, and a strand section between the first and second ends. The second loop element is similar to the first loop element already described. The second loop element is attached to the distal end of the first proximal seal stent 22, in this embodiment to the distal portion of the proximal stent in the same manner as described above for the first loop element, but as with the first loop element, in other embodiments the first end of the second loop element can be attached to the tubular graft body 12. In the illustrated embodiment, the second loop element is attached to the first distal apex 30, which is the same apex to which the first end of the first loop element is attached. In other embodiments, the first ends of the first and second loop elements can be attached to different apices, in which case the effect of the diameter limitation will be reduced.

[0088] The first and second loop elements, particularly their first and second strand sections, are configured to extend or wrap around the distal end of the proximal stent in both directions from their respective first ends, so that the second ends of the first and second loop elements can intersect in a clamping configuration. This clamping configuration can limit the diameter of the distal end of the proximal stent.

[0089] The second end is held by a release wire (not shown) in the clamping configuration to maintain the clamped diameter at the distal end of the proximal stent. In the illustrated embodiment, the first and second loop elements, particularly their strand sections, are configured to extend between them, in the clamping configuration, around the entire circumference of the tubular graft body 12 at the distal end of the first proximal seal stent 22. Each of the first and second loop elements is configured to extend circumferentially along a portion of the circumference of the tubular graft body 12 at the distal end of the first proximal seal stent 22 in the clamping configuration. In the shown embodiment, the release wire and the first and second loops intersect the scallop 32 and the opening 44 at points aligned longitudinally with them (i.e., at the same circumferential position as them).

[0090] In the illustrated embodiment, the first and second loop elements, particularly their strand sections, extend circumferentially in opposite directions around the distal end of the first proximal seal stent 22, overlapping each distal apex 30 through which they pass, and consequently, between them, they overlap all distal apex 30 of the proximal stent in the clamping configuration.

[0091] The size of the loop element determines the size of the diameter reduction at the distal end of the first proximal seal stent 22 in the tightening configuration and the angle of the conical shape formed. The length of the loop element may vary depending on the (expanded) diameter of the prosthesis 10.

[0092] In the illustrated embodiment, in the clamping configuration, the first and second loop elements extend circumferentially in opposite directions around the distal end of the first proximal seal stent 22, and their strand sections are attached to the tubular graft body 12 and / or the first proximal seal stent 22 over most of the distal apex 30 of the proximal stent through which they pass. In other words, over most of the distal apex 30 of the first proximal seal stent 22, the proximal stent and / or the graft body are attached to one or the other of the first and second loop elements. The number of distal apex to which the strand sections are attached is sufficient to condense the stent without the strand sections slipping off. In the illustrated embodiment, the strand sections of the loop elements are attached to the graft body by penetrating the graft material at each apex.

[0093] The attachment of the strand sections of the first and second loop elements to the tubular graft body 12 and / or the first proximal seal stent 22 at the distal apex 30 of the proximal stent can serve to control the loop elements so as not to slip off the distal end of the proximal stent and to prevent them from getting stuck when released. Furthermore, as a result of being attached to the tubular graft body 12 at the distal apex 30 of the first proximal seal stent 22, the loop elements can only slide in the direction circumferentially around the graft and cannot slide along the length of the graft.

[0094] In the illustrated embodiment, in the clamping configuration, each of the first and second loop elements passes through a set of distal apex 30s of the first proximal seal stent 22, and the loop elements, particularly their strand sections, are attached to the tubular graft body 12 over most of the distal apex of each set, and proceed in a sewn manner through the graft material at each of those distal apexes. In the illustrated embodiment, at each distal apex attached to the graft body, the first and second strand sections of each loop element penetrate the tubular graft body 12 and extend from the outside to the inside of the tubular graft body 12, extend around one of the struts 24 of the first proximal seal stent 22 at the distal apex, and then extend from the inside to the outside of the tubular graft body 12. In other words, the strand sections of the loop elements extend radially inward around one of the two struts 24 in most of the distal apex of each set of distal apex 30 of the first proximal seal stent 22, but in other ways extend circumferentially around the outside of the tubular graft body 12. Nevertheless, in other embodiments, the loop elements can be attached to the proximal stent and / or tubular graft body 12 in different ways.

[0095] As can be seen, in the illustrated embodiment, each of the first and second loop elements is attached to the graft body and / or proximal stent only at the distal end of the proximal stent.

[0096] Naturally, in embodiments where the second strand section does not return to the first end of each loop element, only the first strand section may extend circumferentially around the distal end of the proximal stent and be attached to the graft body and / or proximal stent.

[0097] In some embodiments, it is possible to not substantially attach the loop elements to the graft material or proximal stent at their first ends. However, this is undesirable for the reasons stated. Furthermore, in the illustrated embodiments, the first and second strand sections of each loop element are attached to the graft material and / or proximal stent over most of the distal apex of the proximal stent through which they pass, although in other embodiments, only one or the other of the strand sections may be attached in this manner. Furthermore, it is not excluded that the first and / or second strand sections of the first and / or second loop elements may be attached to the proximal stent and / or graft body at multiple locations along the periphery of the graft body other than the distal apex of the proximal stent. However, attachment at the distal apex is preferred for effective tightening of the distal end of the proximal stent.

[0098] In the clamping configuration, the first and second loop elements extend together along the entire circumference of the tubular graft body 12 and the distal end of the first proximal seal stent 22, with the first loop element passing through the loop at the second end of the second loop element, allowing the release wire to pass through the loop at the second end of the first loop element to hold the first and second loop elements in the clamping configuration. Due to the position of the first and second loop elements around the distal end of the proximal stent, the diameter-reducing loop arrangement is configured to clamp the distal apex of the proximal stent, causing the proximal stent to adopt a substantially conical or frustoconical shape. This conical or frustoconical shape allows the proximal seal stent to unfold at a more angular position, resulting in a better fit to the aortic curvature.

[0099] In the illustrated embodiment, the first and second loop elements are made from yarn, which is raw braided PTFE-impregnated polyester fiber suture. Other materials may be used in other embodiments, but the first and second loop elements are preferably provided by suture, most preferably by a single strand thereof.

[0100] In the illustrated embodiment, only the first proximal seal stent 22 is surrounded by a fitting tie 43. However, in other embodiments, one or more of the other stents may have diameter-reducing ties. The most distal stent may optionally have a conventional retention configuration configured to be released in a conventional manner. However, this is not important and therefore not described in detail herein.

[0101] During use, a release wire (not shown) is passed from outside the tubular graft body 12 through the loop at the second end of the first loop element. As a result, both loop elements are attached to and to the release wire. They are held in a clamping configuration by the release wire, which pulls the distal apex of the proximal stent radially inward, holding the seal stent in a substantially conical or frustoconical shape, particularly the proximal side. The diameter-reducing loop arrangement can be released from the clamping configuration by pulling the release wire, thereby freeing the first and second loop elements from each other and allowing their respective second ends to separate. As a result, the loop elements no longer clamp the diameter of the distal end of the first proximal seal stent 22, and consequently the first proximal seal stent 22 expands freely.

[0102] It should also be noted that the release wire passes through the loop at the second end of the first loop element but not through the loop at the second end of the second loop element. In other embodiments, the release wire can pass through the loops at the second ends of both the first and second loop elements. The fitted tie may have any of the features described in Schmidt et al. (Patent Document 8) and (Patent Document 9) ("Stent Graft"), the disclosures of which are incorporated as a whole by reference.

[0103] After being released from the introducer, the prosthesis 10 is partially deployed, thereby holding the first proximal seal stent 22 in a reduced diameter configuration by the fitting tie 43, as shown in Figure 6. The partially deployed configuration allows the clinician to reorient and align the prosthesis 10 within the vessel before fully deploying it. Figure 6 shows an exemplary alignment of the prosthesis 10 in a simulated aortic arch: the proximal end 18 of the tubular graft body 12 is distal to the brachiocephalic artery (BT), the generally straight distal portion of the scallop 32 is aligned between the openings of the left common carotid artery (LCC) and the left subclavian artery (LSA), and the fenestration 44 is aligned with the left subclavian artery (LSA). Once the clinician has positioned the prosthesis 10 as desired, the fitting tie 43 can be released (using the release wire as described above) to initiate full deployment of the prosthesis 10, allowing the first proximal seal stent 22 to expand and engage with the vessel wall. This deployed state can be seen in Figure 7. In the illustrated embodiment, the prosthesis 10 is designed to deploy into a blood vessel with a diameter of 38 mm, and the prosthesis 10 has a fully expanded diameter of 42 mm and is retractable into a sheath with a diameter of 22 Fr (7.33 mm). These dimensions can be adjusted to suit the target blood vessel. In other embodiments, it can have any suitable diameter.

[0104] It should be noted that the specific fitting ties described in detail above are not required in all embodiments. It should also be noted that other arrangements for securing the first proximal seal stent 22 may be used in some embodiments. Another preferred fitting system is disclosed and described in Kolbel et al. (Patent Document 10) ("Introducer for Deploying a Stent Graft in a Curved Lumen and Stent Graft Therefor"), published on January 2, 2018, the disclosure of which is incorporated herein by reference in its entirety.

[0105] A method for placing the prosthesis 10 into the patient's lumen involves intravascular insertion of the prosthesis 10 into the patient's lumen (typically from a femoral approach) and deployment of the prosthesis. The lumen may be curved, in which case the prosthesis 10 is deployed so that its internally curved region is inside the curve of the lumen.

[0106] The lumen is typically located within the patient's vascular system. An embodiment of the prosthesis as shown in the figure is designed to be implanted in the aortic arch between the ascending and descending aorta. A method for positioning the prosthesis 10 in the aortic arch includes inserting the prosthesis 10 into the patient's vascular system using an introducer as described above; orienting the prosthesis 10 within the lumen of the aortic arch such that the medial curvature region is inside the curve of the lumen; and deploying the prosthesis 10 as follows: the first proximal seal stent 22 is deployed substantially perpendicular to the curve of the lumen, the distal end of the scallop 32 is aligned between the subclavian and carotid arteries, and the fenestration 44 is aligned with the junction of the left subclavian artery.

[0107] The advantages include: the ability of the prosthesis to conform to the curvature of the aortic arch while ensuring that the stent does not damage the vessel at the curved portion; support for the left subclavian artery (LSA); and having a minimum proximal seal zone of 10–15 mm. The prosthesis can also be deployed sealed within the short length of available vessel between the subclavian and carotid artery, while the sealing stent (first proximal sealing stent 22) is properly aligned perpendicularly to the vessel in the left subclavian region, reducing the risk of erosion of the vessel. In particular, the prosthesis can be landed in a small area between the subclavian and carotid artery, with wedge-shaped and tapered stents and graft ends conforming to the curvature of the aorta in this area, and nesting stents maximizing the seal in the seal zone.

[0108] As described above, the proximal stent of the preferred embodiment has a wedge shape and a changing radius of curvature at the tip, ensuring that the stent does not corrode the blood vessel and allowing a 42 mm stent / stent graft to be inserted into a 22 Fr (7.33 mm) sheath.

[0109] Although the internal branch graft 46 in the shown embodiment is described as having two distinct parts, in some embodiments it may have three or more parts. These may have longitudinal axes that intersect the longitudinal axis of the tubular graft body 12 at increasingly smaller acute angles, so that each part has a longitudinal axis that intersects at a smaller acute angle than the adjacent proximal part.

[0110] Figures 13-15 show another embodiment of prosthesis 10, which is a stent graft for deployment in the aortic arch. Unless otherwise indicated, the features and modifications of this embodiment of the prosthesis are the same as those described above. However, they are not necessarily required to be so.

[0111] The stent graft includes a plurality of expandable stent rings arranged along the length of a tubular graft material having a proximal end and a distal end, the plurality of stent rings including at least a proximal stent ring 22 located at the proximal end of the tubular graft material, a distal stent ring 23 located at or near the distal end of the tubular graft material, and at least one intermediate stent ring located between the proximal and distal stent rings.

[0112] The upper portion of the prosthesis 10 is shown in Figure 13. The prosthesis 10 includes a graft in the form of a tubular graft body 12, which includes side walls 14 having an internal lumen 16 that penetrates it. The tubular graft body 12 has a proximal end 18 and a distal end 20 (shown in Figures 14 and 15).

[0113] The prosthesis 10 includes a series of stents distributed longitudinally along the tubular graft body 12. Each stent includes multiple peaks and valleys connected in a zigzag arrangement to form a ring around, inside or outside the tubular graft body 12, or inside the tubular graft body 12 itself, with adjacent peaks and valleys connected by struts.

[0114] A scallop 32 is positioned in a first peripheral region at the proximal end 18 of the tubular graft body 12. The dimensions of the scallop 32 can be adjusted to match the target vessel. Barbs 102 are provided in the region of the graft material where the scallop 32 is formed. These help to hold the prosthesis 10 in the correct position during deployment. The barbs 102 extend distally outward from the strut 24 through the graft material and can engage with the aortic wall to prevent migration of the prosthesis. Suitable barbs are disclosed and described in Greenberg et al. (Patent Document 11) ("Thoracic Aortic Aneurysm Stent Graft"), published on June 3, 2004, the contents of which are incorporated herein by reference in their entirety.

[0115] In this embodiment, the scallop 32 is configured to allow a proximal seal zone of about 20 mm to about 40 mm, preferably about 30 mm. The scallop 32 may have a separate reinforcing wire 104 around it, which is sewn to the graft material around its periphery.

[0116] As shown in Figure 13, the proximal seal zone 106 includes two seal stents 108, 110, and the proximal seal stent 108 and the distal seal stent 110 are spaced longitudinally apart from each other such that the distal seal stent 110 is located distal to the distal apex of the proximal seal stent 108. Thus, there is a region of stent-free graft material 112 between the proximal and distal seal stents 108, 110 (forming a ring of stent-free graft material in this embodiment). In this embodiment, the longitudinal range of the region of stent-free graft material 112 is about 3 mm to about 10 mm. The longitudinal range of the region of stent-free graft material 112 may be at least about 3 mm, preferably about 7 mm. Thus, in contrast to the embodiments described above, there is no stent nested with the proximal seal stent 108. The proximal seal stent 108 is located at the proximal end 18 of the prosthesis 10. This is similar to the first proximal seal stent 22 in the embodiments described above. The first proximal seal stent 108 is an internal stent, in other words, positioned around the inner surface of the tubular graft body 12. However, in other embodiments, it may be an external stent or positioned within the thickness of the graft material.

[0117] The proximal stent ring (seal stent 108) comprises a plurality of stent units, each stent unit comprising first and second struts connected by a proximal apex, the stent ring comprising a plurality of distal apexes, and each stent unit being connected to an adjacent stent unit by a distal apex 30. The plurality of stent units comprises at least one scallop unit and at least one support unit 39, the proximal apex of each scallop unit located in the scallop 32, the proximal apex of each support unit 39 located in a second peripheral region separate from a first peripheral region, and the respective first and second struts of at least one scallop unit are shorter than the respective first and second struts of at least one support unit 39.

[0118] The proximal seal stent 108 may contain about 16 to about 28 apex 26, of which 8 to 14 are proximal apex 28 and 8 to 14 are distal apex 30, although in practice this may vary depending, for example, on the diameter of the prosthesis. In other embodiments, any suitable number of apex 26 may be present. For example, in the case of a nitinol stent, each end may have about 5 to about 10 apex. The same number of proximal apex 28 and distal apex 30 is preferred, but not required.

[0119] All body tips 34 are positioned at the proximal edge 56 of the graft material. It is preferable that all body tips 34 are positioned at the proximal edge 56 of the graft material in order to most effectively seal the proximal end 18 of the tubular graft body 12. However, in other embodiments, the body tips 34 can be positioned further distal or proximal than shown.

[0120] In this embodiment, there are three scallop tips 36. The scallop tips 36 are positioned distal to the main body tip 34 adjacent to the scallop 32. In particular, it has been found beneficial that the scallop tips 36 do not extend to the nearest end of the tubular graft body 12. This arrangement reduces the stent struts and tips within the scallop 32 that could normally collide with the vessel wall at the location of a branch vessel, thereby reducing the possibility of trauma or damage to the vessel. Thus, the first proximal seal stent 108 can be said to include a scallop at its proximal end in the region of the scallop 32 of the tubular graft body 12.

[0121] The set of distal apex 30 is all positioned distal to the distal end of the scallop 32, particularly distal to the most distal edge of the scallop 32. Preferably, all or at least most of the distal apex 30 are positioned at least longitudinally at the same level as or distal to the distal end or most distal point of the scallop 32, thereby improving the ability of the proximal seal stent 108 to seal the entire circumference of the scallop 32. In this embodiment, all of the distal apex 30 are also aligned with each other.

[0122] In the embodiments shown, the longitudinal position of the distal apex 30 does not change along the circumference of the tubular graft body 12; that is, the distal apex is at the same level longitudinally. However, in some other embodiments, the longitudinal position of the distal apex 30 may change along the circumference of the graft body in the manner of the embodiments described above. Furthermore, in other embodiments, the distal apex may not be aligned.

[0123] The scallop tip 36 is located at the distal end of the scallop 32. As in the embodiments described above, the body tip 34 is entirely covered, i.e., overlapped, by the graft material. In this embodiment, the tip 26 of the proximal seal stent 108 does not extend beyond the graft material (i.e., the proximal stent is completely covered by the graft material). The strut length is such that the scallop tip 36 is positioned distal to the proximal edge 16 and the distal end of the scallop, thereby being covered by the graft material. This may be particularly beneficial if the proximal seal stent 108 is made of nitinol. The scallop tip 36 is sutured to the graft material at the distal edge of the scallop 32 to hold them in place. The periphery of the scallop is further supported by a wire sutured to it.

[0124] In other embodiments, the scallop tip 36 extends proximal to the proximal edge 16 of the tubular graft body 12 in the scallop 32, in other words, proximal to the distal end of the scallop, and may not be covered by the graft material. As a result, a large, though not all, portion of the first proximal seal stent 22 is covered by the graft material. Nevertheless, the graft covers at least a large portion of each gap between the peaks of the proximal seal stent 108. In other words, the spaces between struts that suffocate to adjacent proximal tips 36 of the proximal seal stent 108 are substantially or completely overlapped by the graft material.

[0125] In this embodiment, the struts 24 vary in length along the periphery of the proximal seal stent 108, forming taller and shorter segments of the stent. In particular, the struts of the scallops are shorter than the struts adjacent to the scallops on both sides. In other words, the first and second struts of each scallop unit are shorter than the first and second struts of each support unit 39.

[0126] Similar to the embodiments shown in Figures 1-7 above, the scalloped tip struts 64 in this embodiment are shorter than most of the body tip struts 66. In other embodiments, all scalloped tip struts 64 are shorter than any of the body tip struts 66. However, it is particularly beneficial for the scalloped tip struts 64 to be shorter than the body tip struts 66 adjacent to the scallop (in other words, those in the support unit 39 described above). In some embodiments, the scalloped tip struts 64 are shorter than only the pair of body tip struts 66 adjacent to the scallop. In other words, it is particularly beneficial for the first and second struts of the scallop unit to be shorter than the first and second struts of the support unit 39. In the embodiments shown, all scalloped tip struts 64 are the same length, but in other embodiments they can be of different lengths.

[0127] In this embodiment, the apex 26 is uniform along the periphery of the proximal seal stent 108, in other words, there is a consistent radius of curvature along its periphery, which results in a uniform radial force around the stent. However, in other embodiments, the proximal seal stent 108 may have apex 26 with different radii of curvature along its periphery, as described in the above embodiment.

[0128] In this embodiment, the proximal seal stent 108 has a proximal-distal length from the proximal end of the stent 108 to the distal end of the proximal seal stent 108, in contrast to the embodiments of Figures 1-7, and this does not change along the circumference of the prosthesis 10. However, in some embodiments, the proximal seal stent 108 may have a proximal-distal length from the proximal end of the stent 108 to the distal end of the proximal seal stent 108 that changes along the circumference of the prosthesis 10.

[0129] Furthermore, in contrast to the proximal end 18 of the first proximal seal stent 22 in the embodiments of Figures 1-7, the proximal end 18 of the proximal seal stent 108 in the embodiments of Figures 13-15 does not have a taper. Nevertheless, some modifications of this embodiment may have a taper similar to that of the embodiments of Figures 1-7.

[0130] The embodiments shown in Figures 13-15, in contrast to the embodiments described above, do not have an inclined proximal end 18 or a wedge-shaped proximal stent. Nevertheless, this does not preclude them, and the prostheses in Figures 13-15 may include these features if desired. As with the embodiments described above, any of the other stents of the prosthesis 10 may have a wedge shape, either similarly or alternatively.

[0131] The second or distal seal stent 110 may have fewer but the same number of apex as the proximal seal stent 108, for example, about 16 to about 28 apex 26, of which 8 to 14 are proximal apex 28 and 8 to 14 are distal apex 30, although in practice this may vary depending, for example, on the diameter of the prosthesis. In other embodiments, any suitable number of apex 26 may be present. For example, in the case of a nitinol stent, each end may have about 5 to about 10 apex, preferably 5 to 9 apex. It is preferable, but not essential, to have the same number of proximal apex 28 and distal apex 30.

[0132] Similar to the embodiments described above, the prosthesis 10 in Figures 13-15 includes at least one window provided in the side wall of a tubular graft material, the window being aligned with the junction of the left subclavian artery and configured to allow a side branch to unfold through it, the window being aligned with the lumen of an internal branch graft located within the lumen of the stent graft, the internal branch graft extending from the window into the lumen of the stent graft.

[0133] In this embodiment, the proximal end of the graft material includes first and second mutually exclusive periphery regions. The first periphery region includes a scallop 32 and is longitudinally aligned with a fenestration 44. The triangular or triangular fenestration 44 is circumferentially aligned with the scallop 32 and is distal to the scallop 32. The fenestration 44 is sized and positioned to receive the opening of a branch vessel when the prosthesis 10 is fully deployed. In the shown embodiment, the prosthesis 10 is designed to deploy within the aortic arch, and where the patient's anatomical structure allows, the fenestration 44 is aligned with the opening of the left subclavian artery. In this embodiment, the distance between the scallop 32 and the fenestration 44 is approximately 30 mm. Therefore, if the patient has a relatively wide landing zone between the left common carotid artery and the left subclavian artery, the device provides an improved seal, considering that it provides proximal and distal seal stents 108, 110 between the scallop 32 and the fenestration 44.

[0134] The opening 44 may be formed by three substantially straight edges or sides joined by three rounded corners, as described above, but in some variations, a longitudinal range may exist at the junction between the side of the opening supported by the stent and the proximal side of the opening. As shown in Figures 13-15, the opening 44 may be formed by a vertical proximal side, two angled sides, and two longitudinally extending sides between the angled sides and the vertical proximal side.

[0135] The distal seal stent 110 is positioned adjacent to the proximal edge 66 of the opening 44, on the proximal side of the opening 44, with its distal tip positioned adjacent to the proximal edge 56 of the opening 44. In the shown embodiment, the distal tip of the distal seal stent 110 does not extend beyond the graft material of the proximal edge 56 of the opening 44. At the same time, the proximal edge 56 of the opening 44 does not extend proximal to the distal tip of the distal seal stent 110.

[0136] The prosthesis 10 includes an internal branch graft (not shown in Figures 13-15). This may have a shape and configuration similar to those of the embodiments described above. Other shapes and configurations are also possible. For example, the internal branch graft may extend distally or proximal within the lumen 16 of the prosthesis 10. In some embodiments, the prosthesis may include a fenestration but not include a branch graft.

[0137] Similar to the embodiments described above, at least one intermediate stent ring is a window-supported stent ring, which is a zigzag-shaped stent having a plurality of proximal apexes and a plurality of distal apexes, the proximal and distal apexes being connected to each other by a plurality of stent struts 55 extending between them, and at least one of the distal apexes being a window-supported apex. In this way, the window 44 is supported by the window-supported stent 50 which is longitudinally aligned with the window 44. The window 44 is provided between two struts 55 of the window-supported stent 50, and the combination of the two struts 55 and the distal apex of the window-supported stent 50 defines two sides 78, 82 and a distal end 84 of the window. In this embodiment, the window-supported stent 50 is positioned outside the graft material, but in other embodiments it may be positioned inside.

[0138] In the prostheses shown in Figures 13-15, the distal and proximal apex of the fenestrated stent all have the same radius of curvature. However, in some embodiments, the distal apex may have a larger radius of curvature than the proximal apex in a manner similar to that of the embodiments described above. Nevertheless, the distal apex has a radius of curvature that matches the curvature of the distal end 84 (angle) of the triangular fenestration 44.

[0139] In the embodiments shown in Figures 13-15, the fenestrated stent 50 has the same number of apex as the distal seal stent 110. Its proximal apex is aligned longitudinally with the distal apex of the distal seal stent 110, and its distal apex is aligned with the proximal apex of the distal seal stent 110. However, this is not mandatory. The proximal apex of the fenestrated stent 50 may also be aligned with the proximal apex of the distal seal stent 110.

[0140] As shown in Figures 13 and 14, the opening 44 has a proximal margin 56, which includes at least a portion substantially perpendicular to the longitudinal axis of the stent graft. The proximal margin 56 of the opening 44 is not closed by the stent placement, but in some embodiments a support wire may be provided along it. However, it is preferable that the proximal margin 56 of the opening is defined solely by suture stitching.

[0141] Similar to the embodiments described above, the prosthesis 10 includes a series of main stents 54. In contrast to the embodiments described above, the proximal and distal sealing stents 108, 110 and the fenestration support stent 50 are not angled relative to the distal end of the prosthesis 10. However, in some embodiments, they may be angled.

[0142] As shown in Figure 14, the most distal stent 114 is located at the distal end of the prosthesis 10. The most distal stent is the most flexible stent in the prosthesis and provides weaker radial forces than the other stents in the prosthesis 10. This reduces the risk of trauma. In this embodiment, the most distal stent 114 may have 16 to 28 apex 26, of which 8 to 14 are proximal apex 28 and 8 to 14 are distal apex 30, but in practice this may vary depending, for example, on the diameter of the prosthesis. Thus, any appropriate number of apex 26 may be present. It is preferable, but not essential, to have the same number of proximal apex 28 and distal apex 30. The apex is connected by struts, which are longer than the struts of the other stents in the prosthesis 10.

[0143] Radiopaque markers 116 are provided to assist in the positioning and alignment of the device during delivery. The markers can be any suitable radiopaque material, including gold, platinum, tantalum, etc. As best seen in Figure 14, two longitudinally positioned markers 116 are provided at the proximal end of the graft material on each side of the scallop. Further markers are provided at the midpoint of the distal edge of the scallop 32. Markers 116 are also provided at each corner of the window 44. In this embodiment, four markers 116 are provided at the distal tip of the window in a longitudinal arrangement. Three further markers 116 lying along the same longitudinal axis are provided along the graft material. The longitudinal alignment of these markers assists in detecting twisting of the prosthesis 10 during deployment. Other suitable radiopaque markers can be incorporated in addition to or instead of the gold markers 116 shown. In one embodiment (not shown), for example, a metal (e.g., platinum) wire or coil may be used to mark the periphery of the scallop 32 and / or window 44. For example, a radiopaque coil may be wound around the scallop wire, the distal strut of the window-supporting stent, or other stent. In another embodiment, such a marker may be arranged in a V-shape to mark the distal tip 63 of the window 44.

[0144] An advantage of the embodiments shown in Figures 13-15 is that a longer seal zone is provided between the scallop 32 and the fenestration 44. The arrangement of the proximal seal stent 108 and distal seal stent 110, with a stent-free area of ​​graft material 112 in between, also provides flexibility. For patients with a relatively wide landing zone between the left common carotid artery and the left subclavian artery, a larger overall seal area is available.

[0145] However, in patients with a small landing zone, the device can be implanted by first aligning the scallop 32 with the left common carotid artery. In this case, the fenestration 44 cannot be aligned with the left subclavian artery. In these cases, a bridging stent graft 118 (shown in Figure 16) can be used to provide fluid communication between the lumen 16 of the prosthesis 10 and the left subclavian artery.

[0146] Figure 16 schematically shows a prosthesis 10 located within the aortic arch of a patient with only a short (less than 30 mm) landing zone between the left common carotid artery and the left subclavian artery. The features shown in this figure are not depicted in proportion to their actual size. It can be seen that a good seal is maintained at the junction between the left common carotid artery and the left subclavian artery by the proximal seal stent 108, while fluid communication between the left common carotid artery and the aortic arch is maintained via the scallop 32.

[0147] In this patient, the fenestration could not be aligned with the junction of the left subclavian artery and the aortic arch, but instead landed approximately 1-2 cm distal to the opening of the left subclavian artery. In this case, a bridging stent graft 118, a side branch, is used to maintain fluid communication between the left subclavian artery and the descending aorta. The bridging stent graft 118 has a proximal end that engages within the internal branch graft 46. The bridging stent graft 118 exits the fenestration 44 and extends along the outside of the tubular graft body 12 of the prosthesis 10 between the distal seal stent 110 and the vessel wall before entering the left subclavian artery.

[0148] At least one of the stent rings 120 of the bridging stent graft 118 has a higher radial force than the distal seal stent 110 of the stent graft. This allows the bridging stent graft 118 to overcome the radial force of the distal seal stent 110 and maintain an open lumen and therefore fluid communication with the left subclavian artery running parallel to the prosthesis 10.

[0149] This configuration allows the proximal seal stent 108 to maintain a good seal. This good seal is further maintained by the distal seal stent 110, which engages with most of the periphery of the vessel wall, except for the portion where the bridging stent graft 118 runs adjacent to it. Nevertheless, the combination of the distal seal stent and the bridging stent 118 provides a good seal within the aorta.

[0150] The stent-free region of the graft material 112 provides a degree of flexibility that allows the distal seal stent 110 to be pushed away from the vessel wall by the bridging stent graft 118 without dislodging the proximal seal stent 108. In this way, the proximal seal stent 108 can maintain a good seal between the prosthesis 10 and the small area available for sealing between the left common carotid artery and the left subclavian artery.

[0151] The stent grafts shown in Figures 13-15, whether or not they are used with the bridging stent 118, can be delivered using any suitable deployment system, such as those described herein or those described in their entirety in the concurrently pending Patent Document 12, which is incorporated herein by reference.

[0152] Therefore, the embodiments shown in Figures 13-15 can be used for a wider range of patient anatomical structures. If the patient has a longer landing zone between the left common carotid artery and the left subclavian artery, the fenestration can be aligned with the left subclavian artery in a manner similar to that of the embodiments shown in Figures 1-7. However, this device can also be used for patients with shorter landing zones, as the fenestration 44 does not need to be aligned with the left subclavian artery but can be fluidly connected to it by the bridging stent 118. Therefore, this device is beneficial for a larger number of patients.

[0153] All optional preferred features and modifications of the embodiments and dependent claims described herein are applicable to all aspects of the invention taught herein. Furthermore, the individual features of the dependent claims and all optional preferred features and modifications of the embodiments described herein are combinable and interchangeable with each other.

[0154] In connection therewith, as described above, a luminal implantable medical device is disclosed, the device comprising: a graft having a proximal end and a distal end, the proximal end comprising first and second peripheral regions, the first peripheral region comprising a scallop; and a stent positioned at the proximal end of the graft, comprising a plurality of stent units comprising first and second stent units, each stent unit comprising first and second struts connected by a proximal apex; the proximal apex of the first stent unit being more rounded than the proximal apex of the second stent unit; the plurality of stent units comprising at least one scallop unit and at least one body unit, each scallop unit having a proximal apex located in the scallop, and each body unit having a proximal apex located in the second peripheral region; the first stent unit being a scallop unit of at least one scallop unit, and the second stent unit being a body unit of at least one body unit. The multiple stent units include at least one support unit having a proximal apex located in a second periphery region, and it is preferable that the first and second struts of each of the at least one scallop unit are shorter than the first and second struts of each of the at least one support unit. Preferably, the second stent unit faces the first stent unit in the diametrical direction. The proximal apex of each of the at least one scallop unit is located proximal to the distal end of the scallop and may not be covered by the graft material.

[0155] The disclosure also provides a lumen implantable medical device, the device comprising a graft having a proximal and distal end, the proximal end comprising first and second peripheral regions, the first peripheral region comprising a scallop; and a stent positioned at the proximal end of the graft, comprising a plurality of stent units, each stent unit comprising first and second struts connected by a proximal apex; the plurality of stent units comprising at least one scallop unit and at least one support unit, the proximal apex of each scallop unit located in the scallop, the proximal apex of each support unit located in the second peripheral region, the respective first and second struts of the at least one scallop unit being shorter than the respective first and second struts of the at least one support unit; and the respective proximal apex of the at least one scallop unit being positioned proximal to the distal end of the scallop and not covered by the graft material.

[0156] Preferably, at least one scallop unit has a proximal apex that is more rounded than the proximal apex of each of the at least one support units. A plurality of stent units may include at least one support unit having a proximal apex located in a second periphery region, and each of the at least one support unit supports a scallop. Similarly, preferably, a plurality of stent units include at least one support unit having a proximal apex located in a second periphery region, each of the at least one support unit is adjacent to a scallop, and optionally, at least one support unit includes support units positioned on both sides of the scallop.

[0157] The multiple stent units may include at least one support unit having a proximal apex located in a second periphery region, wherein the proximal apex of each of the at least one scallop unit is positioned distal to the proximal apex of each of the at least one support unit. Preferably, the proximal apex of each scallop unit is more rounded than the proximal apex of the diametrically opposed body unit. Preferably, the proximal apex of each scallop unit is more rounded than the proximal apex of each support unit. In some embodiments, the proximal apex of each scallop unit is more rounded than the proximal apex of each support unit and the proximal apex of each body unit.

[0158] Multiple stent units may include at least one support unit having a proximal apex located in a second periphery region, with each proximal apex of the at least one support unit overlapping with graft material. Furthermore, each proximal apex of the at least one support unit is preferably located at the proximal edge of the graft. At least a large portion of each of the at least one scallop unit is preferably overlapped with graft material. Furthermore, the proximal apex of each scallop unit is in the first periphery region. In embodiments, the proximal apex of each scallop unit is at the distal end of the scallop.

[0159] The stent of the device according to any of the preceding statements may further include a plurality of distal apexes, and each stent unit is connected to an adjacent stent unit by its distal apex. Preferably, the plurality of distal apexes are arranged in a second periphery region and are positioned at the same level as or distal to the distal end of the scallop in the longitudinal direction. Furthermore, preferably, at least a large portion of the distal apexes of the stent are positioned at the same level as or distal to the distal end of the scallop in the longitudinal direction. In some embodiments, all of the distal apexes of the stent are positioned at the same level as or distal to the distal end of the scallop in the longitudinal direction. It is also preferable that the distal apexes of the stent are substantially aligned with each other.

[0160] Preferably, the proximal apex of at least one scallop unit is more rounded than each distal apex of the stent in the first periphery region. In some embodiments, the proximal apex of each scallop unit is more rounded than each of the distal apex of the stent. Optionally, the distal set of stent apexes all have the same radius of curvature. In some embodiments, the stent apexes located in the second periphery region all have the same radius of curvature. More rounded stent apexes may have a larger radius of curvature.

[0161] The first and second peripheral regions may constitute the entire perimeter of the graft. The first peripheral region may be the same extent as the scallop. Preferably, at least a large portion of the stent is overlapped by the graft material. Preferably, each of at least one support unit is completely covered by the graft material. One or more of the at least one scallop unit may be partially overlapped by the graft material.

[0162] Lumen implantable medical devices are also provided, each comprising a graft having a proximal and distal end, the proximal end comprising first and second peripheral regions, the first peripheral region comprising a scallop; and a stent positioned at the proximal end of the graft, comprising a plurality of stent units, each stent unit comprising first and second struts connected by a proximal apex; the plurality of stent units comprising a plurality of scallop units and at least one body unit, each scallop unit having a proximal apex located in the scallop, and each body unit having a proximal apex located in the second peripheral region. Lumen implantable medical devices may incorporate any of the optional features disclosed herein. In some embodiments, the lumen implantable medical devices of any of the preceding statements are configured to be implanted in a curved lumen.

[0163] The stent is a first stent, having a length from a first end to a second end, with the first end being the proximal end and the second end being the distal end, and the length of the first stent increases in both circumferential directions from the inner curved region of the device, providing the first stent with a wedge shape. The inner curved region is configured to unfold inside the curved portion of the lumen.

[0164] The graft may be a tubular graft, and the stent is located around the graft. In some embodiments, the first end of the first stent is adjacent to the first end of the graft. The proximal end of the graft is inclined with respect to the sidewall of the graft, and may form an obtuse angle with respect to the sidewall in the internally curved region. Preferably, the internally curved region of the device is substantially diametrically opposed to the scallop. The device has a first stent. The first stent may be an end-stent located at the proximal end of the graft. At least a large portion of the first stent may be covered by graft material. The first stent may be the stent of any of the preceding statements. The device may include a second stent adjacent to and distal to the first stent. Each of the first and second stents may include a plurality of proximal peaks and distal valleys, and adjacent peaks and valleys are connected by struts. The peaks of the first stent may be provided by the stent unit described above. In other words, adjacent peaks and valleys within each stent are connected by struts. The graft may cover at least a large portion of each of the multiple gaps between the peaks of the first stent. The struts of the second stent may be shorter than those of the first stent. The peaks of the second stent may be nested in the valleys of the first stent. Furthermore, the device may include any of the optional features disclosed and described below.

[0165] An implantable medical device is also provided, configured to be implanted in a curved lumen, the device comprising a tubular graft and a first stent around the graft; the graft having a first end, a second end and side walls; the first stent having a length from the first end to the second end, the first end of the first stent being adjacent to the first end of the graft, the length of the first stent increasing in both circumferential directions from the inner curved region of the device, providing the first stent with a wedge shape; the first end of the graft being inclined with respect to the side walls, forming an obtuse angle with respect to the side walls of the inner curved region; the inner curved region being configured to unfold inside the curved portion of the lumen. Preferably, the first end of the graft is aligned with the first end of the first stent along at least a large portion of the periphery of the first end of the graft.

[0166] Preferably, the first end of the graft is substantially equidistant from the first end of the first stent along at least a large portion of the circumference of the first end of the graft. In some embodiments, the device has a proximal end and a distal end, and the first end of the stent has a taper such that the longitudinal position of the first end of the stent increases in the proximal-distal direction in both circumferential directions from the inner curvature region of the device. Preferably, the first stent includes a plurality of apexes at its first end, and the taper includes at least three apexes of the first end of the first stent that are offset from each other in the proximal-distal direction in each circumferential direction from the inner curvature region. Preferably, the at least three apexes are adjacent apexes. The taper is preferably linear. The taper provides an offset of about 5 mm to about 20 mm, more preferably about 10 mm to about 20 mm, even more preferably about 13 mm to about 17 mm, and most preferably about 15 mm. The first end of the graft preferably has substantially the same taper as the first end of the stent. In embodiments of the device according to any of the preceding statements, it is particularly advantageous that the taper is configured such that the first end of the first stent extends substantially perpendicular to the curved portion of the lumen.

[0167] The first end of the graft may be configured to deploy substantially perpendicular to the curvature of the lumen. The first stent may be an internal perimeter stent located inside the graft. The first end of the graft is the proximal end of the graft, the first end of the first stent is the proximal end of the first stent, the second end of the graft is the distal end of the graft, and the second end of the first stent is the distal end of the first stent. The first stent may preferably include a scallop at its first end configured to deploy outside the curvature of the lumen. The device according to any of the preceding statements may include at least one further stent spaced apart from the first stent.

[0168] The graft may include a scallop at its first end, preferably configured to extend outside the curve of the lumen. The first stent may be an end-stent located at the first end of the graft. The first end of the graft may be proximal, and the second end may be distal. In some embodiments, the device includes a second stent adjacent to the first stent. The second stent may be distal to the first stent. In embodiments, each of the first and second stents includes a plurality of proximal peaks and distal valleys, and adjacent peaks and valleys are connected by struts.

[0169] The graft may cover at least a large portion of each of the multiple gaps between the peaks of the first stent. The peaks of the second stent may be nested in the valleys of the first stent. The struts of the second stent may be shorter than those of the first stent. In some embodiments, the first end of the graft includes first and second peripheral regions, the first peripheral region having a scallop. The scallop may be substantially diametrically opposed to the inner curved region of the device. In embodiments, the first end of the graft is the proximal end, and the second end of the graft is the distal end. The first stent may be located at the proximal end of the graft.

[0170] In the embodiment, the first stent comprises a plurality of stent units, each comprising first and second stent units, each comprising first and second struts connected by a proximal apex. The proximal apex of the first stent unit may be more rounded than the proximal apex of the second stent unit. The plurality of stent units may comprise at least one scallop unit and at least one body unit, each scallop unit having a proximal apex located in the scallop, and each body unit having a proximal apex located in a second periphery region. The first stent unit may be a scallop unit of at least one scallop unit, and the second stent unit may be a body unit of at least one body unit. The multiple stent units preferably include at least one scallop unit and at least one support unit, wherein the proximal apex of each scallop unit is located in the scallop, and the proximal apex of each support unit is located in a second peripheral region, and the first and second struts of each of the at least one scallop unit are preferably shorter than the first and second struts of each of the at least one support unit.

[0171] The proximal apex of at least one scallop unit is located proximal to the distal end of the scallop and may not be covered by the graft material. Multiple stent units may include multiple scallop units and at least one body unit, each scallop unit having a proximal apex located in the scallop, and each body unit having a proximal apex located in a second peripheral region.

[0172] Furthermore, the device may include any of the optional features disclosed herein. A reference to a stent is deemed to be a reference to the first stent.

[0173] Lumen implantable medical devices are also provided, each comprising: a graft having a proximal and distal end; a first stent which is the outermost stent located at the proximal end of the graft; and a second stent adjacent to the first stent; each of the first and second stents comprising a plurality of proximal peaks and distal valleys, the adjacent peaks and valleys being connected by struts; the graft covering at least a large portion of each of the plurality of gaps between the peaks of the first stent; the struts of the second stent being shorter than those of the first stent; and the peaks of the second stent being nested within the valleys of the first stent. The first and second stents may be separated longitudinally. Preferably, the first and second struts joining to the nested peaks of the second stent are shorter than the first and second struts joining to the adjacent valleys of the first stent. The second stent may be configured to generate a lower radial force than the first stent.

[0174] The graft may include a scallop at its proximal end. The graft further includes an opening, which is located closer to the distal end of the graft than the second stent and is positioned adjacent to the second stent. Preferably, the struts and apex of the second stent form a ring, and at least the majority of the struts of the second stent are shorter than the first strut of the first stent. Preferably, the struts and apex of the first stent form a ring, and all the struts of the second stent are shorter than all the struts of the first stent. Preferably, multiple peaks of the second stent are nested in the valleys of the first stent. Preferably, the nesting is radially symmetrical. Preferably, multiple nested peaks of the second stent include at least the first and second adjacent peaks of the second stent, each nested below each peak of the first stent. Preferably, at least the majority of the peaks of the second stent are nested in the valleys of the first stent. More preferably, each peak of the second stent is nested within the valleys of the first stent. More preferably, each peak of the second stent is nested between each pair of valleys of the first stent.

[0175] The first and second struts that join each nested peak of the second stent may be shorter than the first and second struts that join the adjacent valleys of the first stent. The proximal end of the graft may include first and second peripheral regions, the first peripheral region having a scallop.

[0176] The first stent may comprise a plurality of stent units, each containing first and second stent units, each containing first and second struts connected by a proximal apex. Each proximal apex of the first stent may be the peak of the first stent. Each valley of the first stent may be the distal apex formed by joining the stent units of the first stent. The proximal apex of the first stent unit may be more rounded than the proximal apex of the second stent unit.

[0177] A plurality of stent units may include at least one scallop unit and at least one body unit, each scallop unit having a proximal apex located in the scallop, and each body unit having a proximal apex located in a second peripheral region. The first stent unit is preferably a scallop unit of at least one scallop unit, and the second stent unit is preferably a body unit of at least one body unit.

[0178] The multiple stent units may preferably include at least one scallop unit and at least one support unit, where the proximal apex of each scallop unit is located in the scallop and the proximal apex of each support unit is located in a second peripheral region. Preferably, the first and second struts of each of the at least one scallop unit are shorter than the first and second struts of each of the at least one support unit. The proximal apex of each of the at least one scallop unit is located proximal to the distal end of the scallop and may not be covered by graft material. The multiple stent units may include multiple scallop units and at least one body unit, where each scallop unit has a proximal apex located in the scallop and each body unit has a proximal apex located in a second peripheral region.

[0179] The device may be configured to be implanted in a curved lumen. In embodiments, the graft is a tubular graft. The device may include a first stent around the graft. The first stent may be the first stent according to any of the preceding statements. The first stent may have a length from a first end to a second end, and the length of the first stent increases in both circumferential directions from the inner curved region of the device, providing the first stent with a wedge shape. The first end of the first stent may be adjacent to the proximal end of the graft.

[0180] The proximal end of the graft may be angled relative to the side wall of the graft. The proximal end of the graft may form an obtuse angle with respect to the side wall in the internal curvature region. The internal curvature region of the device may be configured to extend inside the curved portion of the lumen.

[0181] Any of the preceding embodiments of the device may be called a stent graft. The graft is in the form of a tubular graft body. In an embodiment, the device is a stent graft for deployment within the aortic arch. Any of the preceding embodiments of the graft may include a fenestration provided in the side wall of the graft. In an embodiment, the first end of the graft is proximal, and the second end of the graft is distal.

[0182] The opening may have a proximal margin connecting the proximal ends of the two sides of the opening. The proximal margin may preferably include at least a portion substantially perpendicular to the longitudinal axis of the graft.

[0183] A device of any of the preceding embodiments may include a plurality of expandable stent rings arranged along the length of the tubular graft material of the graft. The plurality of expandable stent rings may include at least a proximal stent ring at or near the proximal end of the tubular graft material, a distal stent ring at or near the distal end of the tubular graft material, and at least one intermediate stent ring between the proximal and distal stent rings.

[0184] The proximal stent ring may be a first stent in any of the preceding embodiments. One of the at least one intermediate stent ring may be a second stent in any of the preceding embodiments. The distal stent ring may be an additional stent and is the distal end stent of the device. At least one intermediate stent ring may include a fenestrated stent ring. The fenestrated stent ring may be a zigzag-shaped stent having a plurality of proximal and distal apices, the proximal and distal apices being connected to each other by a plurality of stent struts extending between them. In embodiments, the proximal apices of the fenestrated stent ring form a peak, and the distal apices of the fenestrated stent ring form a valley.

[0185] At least one of the distal apex portions of a fenestrated stent ring may be a fenestrated support apex. The fenestrated support apex preferably has a larger radius of curvature than the proximal apex of the fenestrated stent ring. In a preferred embodiment, the fenestration is provided between two struts of the fenestrated stent ring, and the combination of the two struts of the fenestrated stent ring and the fenestrated support apex defines the two lateral portions and the distal end of the fenestration. In a particular embodiment, the fenestration is configured for alignment with the junction of the left subclavian artery and for the deployment of a collateral branch passing through it. The fenestration may be aligned with the lumen of an internal branch graft located within the lumen of the stent graft. The internal branch graft may extend distally from the fenestration into the lumen of the stent graft.

[0186] Furthermore, the device may include any of the other features disclosed herein.

[0187] A stent graft for deployment in the aortic arch is also provided, which comprises a plurality of expandable stent rings arranged along the length of a tubular graft material, including at least a proximal stent ring at or near the proximal end of the tubular graft material and a distal stent ring at or near the distal end of the tubular graft material and at least one intermediate stent ring between the proximal and distal stent rings; and at least one fenestration provided in the side wall of the tubular graft material, the fenestration being aligned with the junction of the left subclavian artery and configured to deploy a side branch through it; and at least one intermediate stent ring , a fenestrated stent ring, the fenestrated stent ring being a zigzag-shaped stent having a plurality of proximal apexes and a plurality of distal apexes, the proximal and distal apexes being connected to one another by a plurality of stent struts extending between them, at least one of the distal apexes being a fenestrated apex having a larger radius of curvature than the proximal apex; at least one fenestration being provided between two struts of the fenestrated stent ring, the combination of the two struts of the fenestrated stent ring and the fenestrated apex defining two sides and a distal end of the fenestration; the fenestration having a proximal margin connecting the proximal ends of the two sides of the fenestration, the proximal margin including at least a portion substantially perpendicular to the longitudinal axis of the stent graft.

[0188] Preferably, a seal stent ring is provided adjacent to the proximal edge of the fenestration. The seal stent ring may be a zigzag-shaped stent having a proximal and distal apex, and optionally, the proximal edge of the fenestration does not extend proximal to the distal apex of the seal stent ring.

[0189] In some embodiments, the sidewall of the tubular graft material is provided with only a single opening. The opening is preferably aligned with the scallop at the proximal end of the stent graft and located distal to the scallop, with a sealing zone between them. The opening-supporting stent ring can be positioned around the tubular graft material at an angle such that the opening-supporting apex is located proximal to the distal apex on the opposite circumferential side of the opening-supporting stent ring.

[0190] In a preferred embodiment, the tubular graft material is tapered at its proximal end, and the window support stent ring is angled within the tubular graft body at an angle that matches the angle of the taper at the proximal end of the tubular graft material.

[0191] Multiple distal apexes may have a larger radius of curvature than the proximal apex. All distal apexes may also have a larger radius of curvature than the proximal apex. Preferably, at least the fenestrated support apex has a radius of curvature of 2 mm to 4.5 mm, most preferably about 3.75 mm. All distal apexes of a fenestrated stent ring may have a radius of curvature of 2 mm to 4.5 mm, more preferably about 3.75 mm. Preferably, part or all of the proximal apex of a fenestrated stent ring has a radius of curvature of 0.5 mm to 1.5 mm, most preferably about 0.75 mm.

[0192] A preferred embodiment of the stent graft may include a branched graft extending distally from the opening and into the tubular graft material. The branched graft may be angled relative to the tubular graft material of the stent graft so that it also extends laterally from the opening as the branched graft extends distally. The branched graft is preferably angled at an angle in the range of 5 to 45 degrees, most preferably about 16 degrees, when measured from the central longitudinal axis of the stent graft. Preferably, the branched graft has a proximal portion having a proximal longitudinal axis and a distal portion having a distal longitudinal axis, wherein the proximal longitudinal axis of the proximal portion intersects the longitudinal axis of the stent graft at an acute angle, and the distal longitudinal axis of the distal portion intersects the longitudinal axis of the stent graft at an acute angle, and the acute angle between the distal longitudinal axis and the longitudinal axis of the stent graft is smaller than the acute angle between the proximal longitudinal axis and the longitudinal axis of the stent graft.

[0193] In a preferred embodiment, the nearest portion of the branched graft is generally frustoconical, and the farthest portion of the branched graft is cylindrical. The nearest portion of the branched graft may be the proximal portion described above, and the farthest portion of the branched graft may be the distal portion described above.

[0194] Also provided is a stent graft for deployment in the aortic arch, the stent graft comprising a plurality of expandable stent rings arranged along the length of a tubular graft material, the plurality of expandable stent rings including at least a proximal stent ring at or near the proximal end of the tubular graft material and a distal stent ring at or near the distal end of the tubular graft material and at least one intermediate stent ring between the proximal and distal stent rings; and at least one fenestration provided in the side wall of the tubular graft material, the fenestration being aligned with the junction of the left subclavian artery and configured to deploy a side branch through it; the fenestration being aligned with the lumen of an internal branch graft located within the lumen of the stent graft; and the internal branch graft extending distally from the fenestration within the lumen of the stent graft.

[0195] The internal branch graft may be angled within the lumen of the stent graft so that it extends laterally from the fenestration as it extends distally. The internal branch graft is preferably angled at an angle in the range of 5 to 45 degrees, most preferably at an angle of about 16 degrees, when measured from the central longitudinal axis of the stent graft.

[0196] Preferably, the internal branch graft has a proximal portion having a proximal longitudinal axis and a distal portion having a distal longitudinal axis, the proximal longitudinal axis of the proximal portion intersects the longitudinal axis of the stent graft at an acute angle, the distal longitudinal axis of the distal portion intersects the longitudinal axis of the stent graft at an acute angle, and the acute angle between the distal longitudinal axis and the longitudinal axis of the stent graft is smaller than the acute angle between the proximal longitudinal axis and the longitudinal axis of the stent graft.

[0197] Preferably, the most proximal portion of the internal branch graft is generally frustoconical, and the most distal portion of the internal branch graft is cylindrical. The most proximal portion of the internal branch graft may be the proximal portion described above, and the most distal portion of the internal branch graft may be the distal portion described above.

[0198] The length of the tubular graft material forms a graft having a proximal end and a distal end. In embodiments, the device has a first stent. The first stent may be an end-stent located at the proximal end of the graft. The first stent may be a proximal stent ring. The device may include a second stent adjacent to the first stent and distal to the first stent. The second stent may be one of at least one intermediate stent ring. Each of the first and second stents may include a plurality of proximal peaks and distal valleys. In embodiments, the adjacent peaks and valleys of each of the first and second stents are connected by struts. Preferably, the graft covers at least a large portion of each of the plurality of gaps between the peaks of the first stent. The peaks of the second stent may be nested between the valleys of the first stent. The struts of the second stent may be shorter than those of the first stent.

[0199] Furthermore, the device may include any of the optional features disclosed herein.

[0200] A stent graft is an implantable medical device configured to be implanted in a curved lumen. In embodiments, the stent graft is an implantable medical device comprising a tubular graft and a first stent surrounding the graft. In embodiments, the tubular graft has a first end, a second end, and side walls. The first stent may be a proximal stent ring, one of at least one intermediate stent ring, or a distal stent ring. The first stent has a length from the first end to the second end. The length of the first stent may increase in both circumferential directions from the inner curved region of the device, providing a wedge shape to the first stent. The first end of the first stent may be adjacent to the first end of the graft.

[0201] The first end of the graft may be inclined with respect to the lateral wall. The first end of the graft may form an obtuse angle with respect to the lateral wall in the medial curvature region. The first end of the graft is the proximal end, and the second end of the graft is the distal end. The medial curvature region is configured to unfold medially within the curve of the lumen. The lumen may be the aortic arch.

[0202] The proximal stent ring may include a plurality of stent units, each containing first and second stent units, with each stent unit containing first and second struts connected by a proximal apex. The proximal apex of the first stent unit may be more rounded than the proximal apex of the second stent unit. The proximal end of the tubular graft material may include first and second peripheral regions, the first peripheral region having a scallop. The proximal stent ring may be positioned at the proximal end of the tubular graft material.

[0203] A plurality of stent units may include at least one scallop unit and at least one body unit, each scallop unit having a proximal apex located in the scallop, and each body unit having a proximal apex located in a second periphery region. A first stent unit may be a scallop unit of at least one scallop unit, and a second stent unit may be a body unit of at least one body unit.

[0204] A plurality of stent units may include at least one scallop unit and at least one support unit, wherein the proximal apex of each scallop unit is located in the scallop, and the proximal apex of each support unit is located in a second peripheral region, and preferably, the first and second struts of each of the at least one scallop unit are shorter than the first and second struts of each of the at least one support unit. The proximal apex of each of the at least one scallop unit is located proximal to the distal end of the scallop and may not be covered by the graft material.

[0205] Multiple stent units may include multiple scallop units and at least one body unit, each scallop unit having a proximal apex located on the scallop, and each body unit having a proximal apex located on a second peripheral region. Furthermore, the device may include any optional features of the first and second embodiments, and a reference to a stent is considered a reference to a proximal stent ring.

[0206] Furthermore, the device may include any of the optional features.

[0207] Implantable medical devices are also provided that are configured to be implanted in a curved lumen, the device comprising a tubular graft; the graft having a first end, a second end and a side wall; the first end of the graft being inclined with respect to the side wall, forming an obtuse angle with respect to the side wall in the internal curved region of the device; and the internal curved region being configured to unfold inside the curved portion of the lumen. Furthermore, the device may include any of the optional features disclosed herein.

[0208] A stent graft for deployment in the aortic arch is also provided, which comprises a plurality of expandable stent rings arranged along the length of a tubular graft material having a proximal and distal end, including at least a proximal stent ring at the proximal end of the tubular graft material and a distal stent ring at or near the distal end of the tubular graft material, and at least one intermediate stent ring between the proximal and distal stent rings; provided on the side wall of the tubular graft material The stent includes at least one fenestration configured to extend a lateral branch through it; the fenestration is aligned with the lumen of an internal branch graft located within the lumen of the stent graft; the internal branch graft extends from the fenestration into the lumen of the stent graft; and at least one intermediate stent ring is a fenestration-supporting stent ring, which is a zigzag-shaped stent having a plurality of proximal and distal apexes, the proximal and distal apex being supported by a plurality of stent struts extending between them. The two struts of the stent ring are connected to each other, and at least one of the distal apex is a window support apex; at least one window is provided between the two struts of the window support stent ring, and the combination of the two struts of the window support stent ring and the window support apex defines the two sides and distal end of the window; the window has a proximal margin, which includes at least a portion substantially perpendicular to the longitudinal axis of the stent graft; the proximal end of the graft material includes first and second peripheral regions, the first peripheral region being a scalar aligned longitudinally with the window The proximal stent ring may include a plurality of stent units, each stent unit including first and second struts connected at the proximal apex, the stent ring including a plurality of distal apex, each stent unit connected to an adjacent stent unit by its distal apex; the plurality of stent units may include at least one scallop unit and at least one support unit, the proximal apex of each scallop unit located in the scallop, and the proximal apex of each support unit located in a second periphery region;The first and second struts of at least one scallop unit are shorter than the first and second struts of at least one support unit.

[0209] At least a large portion of each of at least one scallop unit is preferably overlapped by graft material. In one embodiment, the proximal apex of at least one scallop unit does not extend proximal to the graft material in the scallop. Multiple stent units may include multiple scallop units. Multiple stent units may include at least one body unit, each body unit having a proximal apex located in a second peripheral region. The proximal edge of the opening can connect the proximal ends of the two sides of the opening.

[0210] A seal stent ring may be provided adjacent to the proximal edge of the window. The seal stent ring may be located distal to the proximal stent ring. The seal stent ring may have multiple proximal apexes, and the proximal apex of the seal stent ring may be located distal to the distal apex of the proximal stent ring, resulting in a region of stent-free graft material between the proximal stent ring and the seal stent ring. The length of the region of stent-free graft material between the proximal stent ring and the seal stent ring may be about 20 mm to about 40 mm, preferably about 30 mm. Thus, only two stents are provided on the proximal side of the window; these are the proximal stent ring at the proximal end of the stent graft and the seal stent ring provided adjacent to the proximal edge of the window.

[0211] A sealed stent ring may be a zigzag-shaped stent having a proximal and distal apex, and the proximal edge of the opening may not extend proximal to the distal apex of the sealed stent ring. Only a single opening may be provided in the sidewall of the tubular graft material. Multiple stent units may include at least one support unit having a proximal apex located in a second periphery region, each of which supports a scallop. Multiple stent units may include at least one support unit having a proximal apex located in a second periphery region, each of which is adjacent to a scallop. Optionally, at least one support unit may include support units positioned on both sides of the scallop. Multiple stent units may include at least one support unit having a proximal apex located in a second periphery region, where the proximal apex of each of the at least one scallop units is positioned distal to the respective proximal apex of each of the at least one support unit. Multiple stent units may include at least one support unit having a proximal apex located in a second peripheral region, the proximal apex of each of the at least one support unit being superimposed by graft material.

[0212] The proximal apex of at least one support unit can be positioned at the proximal edge of the graft. The distal apex of the proximal stent ring is preferably located in the second periphery region and positioned at the same level as or distal to the distal end of the scallop in the longitudinal direction. At least the majority of the distal apex of the proximal stent ring is positioned at the same level as or distal to the distal end of the scallop in the longitudinal direction. The distal apex of the proximal stent ring can be substantially aligned with each other. Generally, the first and second periphery regions constitute the complete periphery of the graft.

[0213] Features of prior disclosures may also be included.

[0214] A kit is also provided that includes a stent graft as described above and a bridging stent graft, the bridging stent graft being configured to deploy into the patient's left subclavian artery and to engage with a fenestration and at least the proximal end of the internal branch graft of the ninth embodiment of the stent graft, the bridging stent graft may include a tubular graft material having a plurality of stent rings arranged along its length, the ninth embodiment of the stent graft may include a seal stent ring adjacent to the proximal edge of the fenestration, and at least one of the stent rings of the bridging stent graft has a higher radial force than one or more seal stent rings of the stent graft described above.

[0215] Two or more stent rings of a bridging stent graft may have a higher radial force than the seal stent ring of the stent graft. For example, at least two, at least three, or at least four stent rings of a bridging stent graft may have a higher radial force than the seal stent ring of the stent graft.

[0216] Methods are also provided that include inserting a device conforming to any of the disclosures herein into the human vascular system; and deploying the device in the aortic arch. The method may further include deploying the device in the aortic arch such that the distal end of the scallop is aligned between the subclavian artery and the carotid artery.

[0217] A deployment system is also provided which is configured to deploy a device of any of the preceding embodiments, the system including an introducer configured to deploy the device into a curved lumen, the device being mounted on the introducer such that its inner curved region is deployed inside the curve of the lumen. The introducer may preferably include a pre-curved cannula.

[0218] A method is also provided for deploying a device according to any of the preceding embodiments into a curved portion of a lumen using the deployment system described above, the method comprising deploying a device having an internal curved region into the internal curve of a lumen. The method may include deploying a wedge-shaped stent of the device such that the first end of the wedge-shaped stent and / or the first end of the graft are positioned substantially perpendicular to the curve of the lumen. The lumen may be the aortic arch, preferably between the ascending and descending aortas.

[0219] A method is also provided which includes inserting a device according to any of the preceding embodiments into the human vascular system; and deploying the device in the aortic arch. The method may further include deploying the device in the aortic arch such that a stent having one or more nested peaks is positioned between the subclavian artery and the carotid artery. [Explanation of symbols]

[0220] 10 Prostheses 12. Tubular graft body 14 Side wall 16 lumen 18 Proximal end 20 Distal end 22 Proximal seal stent 23 Distal end seal stent 24 strut 26 Apex 28 Proximal apex 30 Distal apex 32 Scallop 34 Main body tip 36 Scalloped tip 38 Lateral edge 39 Support Unit 40 Sides extending in the longitudinal direction 42 stitches 43 Suitable Thailand 44 Fenestration 46 Internal branch graft 48. Nesting stents 50 Open window support stent 51 Proximal apex 52 Auxiliary stent 53 Distal apex 54 Main stent 55 strut 56 Proximal margin 57 Proximal apex 58 First surrounding area 59 Distal apex 60 Second surrounding area 61 Strut 62 Inner curvature region 63 Distal end 64 Scalloped Point Strut 65 Distal apex 66 Main body tip strut 67 Strut 68 lines 70 lines 72 Proximal apex 74 Distal apex 76 strut 78 The converging side 80 Proximal side 82 Focusing side 84. Rounded corners 86. Rounded corners 88. Rounded corners 90 Proximal portion 92 Distal portion 94 Proximal D-ring 96 Distal O-ring 98 Opposed strut 100 Introducers 102 Barb 104 Reinforcement wire 106 Proximal seal zone 108 Proximal Seal Stent 110 Distal seal stent 112 Stent-free graft materials 118 Bridging stent graft 120 Stent Rings

Claims

[Claim 1] A stent graft for deployment in the aortic arch, A plurality of expandable stent rings arranged along the length of a tubular graft material having a proximal end and a distal end, each comprising at least a proximal stent ring at the proximal end of the tubular graft material, a distal stent ring at or near the distal end of the tubular graft material, and at least one intermediate stent ring between the proximal stent ring and the distal stent ring; At least one opening provided in the side wall of the tubular graft material; Internal branches positioned within the lumen and extending from the opening toward the end of the stent graft; The first and second peripheral regions at the proximal end of the graft material; A scallop within the first peripheral region, wherein the scallop is aligned longitudinally with the opening. Includes, The at least one intermediate stent ring is a fenestrated stent ring, the fenestrated stent ring is a zigzag-shaped stent having a plurality of proximal apexes and a plurality of distal apexes, the proximal and distal apexes being connected to each other by a plurality of stent struts extending between them, and at least one of the distal apexes being a fenestrated apex; At least one opening is provided between two struts of the opening-support stent ring, and the combination of the two struts of the opening-support stent ring and the opening-support apex defines the two sides and distal end of the opening; The opening has a proximal margin, which includes at least a portion substantially perpendicular to the longitudinal axis of the stent graft; The proximal stent ring comprises a plurality of stent units, each stent unit comprising first and second struts connected by a proximal apex, the stent ring comprising a plurality of distal apexes, each stent unit being connected by a distal apex to an adjacent stent unit; The plurality of stent units each include at least one scallop unit and at least one support unit, wherein the proximal apex of each scallop unit is located on the laterally extending edge of the scallop within the first peripheral region, and the proximal apex of each support unit is located within the second peripheral region; A stent graft in which the first and second struts of each of the at least one scallop unit are shorter than the first and second struts of each of the at least one support unit.

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