Stent graft systems and methods with cuff and limb

Abstract

To provide endoluminal vascular prostheses and methods of placing / deploying such prostheses.SOLUTION: A stent graft system includes a first graft, a second graft, and a third graft. Each of the first graft, the second graft and the third graft forms a single lumen. When deployed, the first graft, the second graft and the third graft are coupled together within an aorta.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED PATENT APPLICATIONS] This application claims priority from U.S. Provisional Patent Application No. 62 / 735,771, filed September 24, 2018, the entire contents of which are incorporated herein by reference.

[0002] The present technology relates generally to endoluminal vascular prostheses and methods of deploying such prostheses. More specifically, the various configurations disclosed herein relate to stent-graft systems and methods of deploying such stent-graft systems to treat aortic aneurysms. [Background technology]

[0003] Aneurysms are enlargements or bulges in blood vessels that are often prone to rupture and therefore pose a serious risk to the patient. Aneurysms can occur in any blood vessel, but are of particular concern when they occur in the cerebral vasculature or aorta.

[0004] Abdominal aortic aneurysms (AAAs) are classified based on their location within the aorta, as well as their shape and complexity. Aneurysms found below the renal arteries are called infrarenal abdominal aortic aneurysms. Suprarenal abdominal aortic aneurysms occur above the renal arteries. Thoracic aortic aneurysms (TAA) occur in the ascending, transverse, or descending portions of the aorta. Infrarenal aneurysms are the most common, representing approximately 70% of all aortic aneurysms. Suprarenal aneurysms are less common, representing approximately 20% of aortic aneurysms. TAAs are the least common and often the most difficult to treat. Summary of the Invention [Problem to be solved by the invention]

[0005] The most common form of aneurysm is "fusiform," in which the enlargement extends around the entire circumference of the aorta. Less commonly, aneurysms may be characterized by a bulge attached to a narrow neck on one side of the vessel. TAAs are often dissecting aneurysms caused by hemorrhagic detachment in the aortic wall, usually within the medial lamina. The common treatment for each of these types and forms of aneurysm is open repair, which is quite successful in patients who are otherwise reasonably healthy and have no significant comorbidities. However, such open procedures are problematic because access to the abdominal and thoracic aorta is difficult to gain and because the aorta must be clamped, placing significant strain on the patient's heart.

[0006] Endoluminal grafts have been widely used to treat aortic aneurysms in patients. A typical endograft procedure utilizes a stent-graft placement to treat the aneurysm. The purpose of the graft is generally to isolate the diseased portion of the aortic wall from aortic blood pressure and to prevent further expansion or rupture of the diseased portion of the aortic wall. Typically, endoluminal repairs access the aneurysm "endoluminally" through either or both of the iliac arteries. A graft is then implanted. A successful endoluminal procedure has a much shorter recovery period than an open procedure. [Means for solving the problem]

[0007] Various stent-graft systems and methods described herein relate to treating aneurysms. In some configurations, the stent-graft system includes a first graft, a second graft, and a third graft. Each of the first graft, the second graft, and the third graft forms a single lumen. When deployed, the first graft, the second graft, and the third graft are coupled to one another within the aorta.

[0008] In some configurations, the second graft and the third graft are inserted into a single lumen of the first graft when deployed. In some configurations, a portion of the first graft is positioned in the proximal neck region of the aorta when deployed. A portion of the second graft is positioned in the first iliac artery of the aorta when deployed. A portion of the third graft is positioned in the second iliac artery of the aorta when deployed.

[0009] In some arrangements, the first graft, the second graft, and the third graft are separate grafts prior to deployment. In some arrangements, the stent-graft system further includes an inflatable filling structure at least partially surrounding the first graft. The inflatable filling structure expands within the aorta upon deployment. A sealing component is coupled to the first graft. The sealing component forms a seal in the proximal neck region of the aorta.

[0010] In some arrangements, the sealing component is filled to a pressure higher than the pressure of the inflatable filling structure. In some examples, the sealing component and the inflatable filling structure are filled using different channels. In some examples, the inflatable filling structure, when deployed, at least partially surrounds the proximal ends of the second and third grafts docked within the single lumen of the first graft. In some examples, the inflatable filling structure is coupled to the first graft. In some examples, the second and third grafts dock within the single lumen of the first graft at a docking zone. In the inflated state, the inflatable filling structure surrounds at least portions of the second and third grafts that are outside the docking zone. In some examples, the inflatable filling structure is coupled to the first graft. In the inflated state, the inflatable filling structure surrounds portions of the second and third grafts that are inside the iliac arteries when deployed.

[0011] In some examples, the second graft and the third graft dock within a single lumen of the first graft at a docking zone. The first graft includes a supporting expandable filling structure coupled to a portion of the first graft at the docking zone. The supporting expandable filling structure is expanded to provide structural integrity to the first graft. In some examples, the supporting expandable filling structure is expanded before or while the expandable filling structure is expanded. In some examples, the second graft and the third graft dock within a single lumen of the first graft at the docking zone. The first graft includes a wound stent component coupled to a portion of the first graft at the docking zone. The wound stent component includes a plurality of wound rings. In some examples, the single lumen of the first graft is open at the wound stent component. In some examples, the second graft and the third graft dock within a single lumen of the first graft at the docking zone. The first graft includes a wound stent ring coupled to a portion of the first graft at a docking zone, the wound stent ring including a single ring of wound stent.

[0012] In some examples, the expandable filling structure is more flexible than the sealing component. In some examples, the expandable filling structure forms a funnel shape in an inflated state. In some examples, the expandable filling structure forms a funnel shape by having a portion of the expandable filling structure adjacent the wall of the aorta extend further along the wall of the aorta than another portion of the expandable filling structure abutting and adjacent the first graft. In some examples, the expandable filling structure is a branched expandable filling structure that forms two lumens for receiving the second and third grafts when in an inflated state.

[0013] In some arrangements, the stent-graft system further includes a first expandable filling structure at least partially surrounding the first graft, a second expandable filling structure at least partially surrounding the second graft, and a third expandable filling structure at least partially surrounding the third graft, wherein the first, second, and third expandable filling structures are separate expandable filling structures that expand within the aorta when deployed. In some examples, the first expandable filling structure expands within a single lumen of the first graft.

[0014] In some cases, the second expandable filling structure surrounds a portion, but not all, of the outer surface of the second graft. The third expandable filling structure surrounds a portion, but not all, of the outer surface of the third graft. In some cases, the second expandable filling structure surrounds the entire outer surface of the second graft. The third expandable filling structure surrounds the entire outer surface of the third graft.

[0015] In some arrangements, the stent-graft system further includes an expandable filling structure coupled to the first graft. The expandable filling structure forms a seal at the proximal neck region of the aorta while in an expanded state. The second graft and the third graft dock within a single lumen of the first graft at a docking zone. The expandable filling structure surrounds at least portions of the second graft and the third graft that are outside the docking zone while in the expanded state. The expandable filling structure at least partially surrounds the first graft while in the expanded state.

[0016] In some arrangements, the stent-graft system further includes a first expandable filling structure at least partially surrounding the second graft and a second expandable filling structure at least partially surrounding the third graft. When deployed, the first and second expandable filling structures expand within the aorta to at least partially surround the first graft. In some examples, the second and third grafts each include a wound stent component. The wound stent component includes a plurality of wound rings. In some examples, the first and second expandable filling structures are secured to portions of the second and third grafts inserted into the lumen of the first graft. The first and second expandable filling structures expand within the lumen of the first graft. In some examples, the first and second expandable filling structures expand into the lumen of the first graft.

[0017] In some arrangements, the second graft and the third graft dock within the single lumen of the first graft at the docking zone. The first graft includes at least one supportive, inflatable filling structure coupled to a portion of the first graft at the docking zone. The second graft and the third graft are inserted into respective openings of the at least one supportive, inflatable filling structure when inserted into the single lumen of the first graft at the docking zone. The at least one supportive, inflatable filling structure provides a seal for the first graft, the second graft, and the third graft within the lumen of the first graft. In some examples, the openings have a bilobed shape.

[0018] In some arrangements, the second graft and the third graft dock within the single lumen of the first graft at a docking zone. The first graft includes at least one internal support component coupled to a portion of the first graft at the docking zone. The internal support component expands within the single lumen of the first graft upon inflation and forms a seal around the second graft and the third graft when the second graft and the third graft are inserted into the single lumen of the first graft at the docking zone. In some arrangements, the first graft includes a seal component coupled to a distal end of the first graft.

[0019] In some arrangements, the second graft and the third graft dock within the single lumen of the first graft at a docking zone. The first graft includes an internal inflatable filling structure coupled to the first graft at the docking zone. The internal inflatable filling structure expands within the single lumen of the first graft upon inflation and forms a seal around the second graft and the third graft when the second graft and the third graft are inserted into the single lumen of the first graft at the docking zone. The internal inflatable filling structure forms a branch lumen.

[0020] In some examples, the branch lumen is formed by inflating a proximal portion of the inner expandable filling structure around a first balloon having a circular or oval cross-section and a distal portion of the inner expandable filling structure around a second balloon having a bilobal cross-section.

[0021] In some arrangements, the first graft includes a laminated stent component, hi some instances, the laminated stent component includes a Teflon laminated nickel-titanium (NiTi) stent.

[0022] In some arrangements, the stent-graft system includes anchors configured to attach the first graft to the aorta. The anchors include hooks or barbs. In some arrangements, the anchors are positioned on stent rings of the first graft. In some arrangements, the first graft includes a support structure coupled to the first graft and located within the lumen of the first graft. In some examples, the support structure includes a helical polymeric support ring.

[0023] In some arrangements, the stent-graft system includes a graft forming a lumen and at least one support component embedded in the graft. Each of the at least one support component is a polymer ring surrounding the graft. At least a portion of each of the at least one support component is bonded to an outer surface of the graft, the outer surface facing outward from the lumen. In some examples, the at least one support component includes a first support component and a second support component. The first support component is positioned on a first end of the graft. The second support component is positioned on a second end of the graft. In some examples, the at least one support component includes three or more support components spaced apart from one another along the graft. In some examples, the graft further forms a bifurcation feature including two additional lumens that receive a limb stent graft. In some examples, the graft further includes an inner sleeve or ring within the lumen that receives the limb stent graft.

[0024] In some arrangements, the system includes a proximal extension, expandable filling structure that forms a seal at the proximal neck region of the aorta when the proximal extension, expandable filling structure is inflated. The system further includes at least one lumen formed by the proximal extension, expandable filling structure when the proximal extension, expandable filling structure is inflated. Each of the at least one lumen receives a limb stent graft, and the at least one lumen is positioned at the proximal neck region when the proximal extension, expandable filling structure forms a seal at the proximal neck region. In some arrangements, the system further includes an anchor coupled to the proximal extension, expandable filling structure. In some examples, the length of the anchor is 30 mm. In some examples, the width of the proximal extension, expandable filling structure when filled is 20 mm. In some examples, the proximal extension, expandable filling structure is an internal bag. [Brief explanation of the drawings]

[0025] [Figure 1] 1 is a cross-sectional view of an exemplary infrarenal aortic aneurysm in a patient. [Figure 2] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 3A] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 3B] 3A-3D are cross-sectional views of an exemplary stent-graft system (FIG. 3A) deployed across an aneurysm in various configurations. [Figure 4A] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 4B] 4A-4C are cross-sectional views of an exemplary stent-graft system (FIG. 4A) deployed across an aneurysm in various configurations. [Figure 5] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 6A] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 6B] 6A-6C are cross-sectional views of an exemplary stent-graft system (FIG. 6A) deployed across an aneurysm in various configurations. [Figure 7] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 8] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 9] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 10] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 11A] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 11B] 11A-11C are cross-sectional views of an exemplary stent-graft system (FIG. 11A) deployed across an aneurysm in various configurations. [Figure 12] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 13A] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 13B] 13A-13C are cross-sectional views of an exemplary stent-graft system (FIG. 13A) deployed across an aneurysm in various configurations. [Figure 14] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 15A] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm (FIG. 1) in various configurations. [Figure 15B] 15A-15C are cross-sectional views of an exemplary stent-graft system (FIG. 15A) deployed across an aneurysm (FIG. 1) in various configurations. [Figure 15C]15A-15C are further cross-sectional views of an exemplary stent-graft system (FIG. 15A) deployed across an aneurysm (FIG. 1) in various configurations. [Figure 16] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm in various configurations. [Figure 17] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm 14 (FIG. 1) in various configurations. [Figure 18] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm 14 (FIG. 1) in various configurations. [Figure 19] 1A-1C are cross-sectional views of an exemplary stent-graft system deployed across an aneurysm 14 (FIG. 1) in various configurations. [Figure 20A] 1A-1C show examples of proximal grafts with various configurations. [Figure 20B] 1A-1C show examples of proximal grafts with various configurations. [Figure 20C] 1A-1C show examples of proximal grafts with various configurations. [Figure 20D] 1A-1C show examples of proximal grafts with various configurations. [Figure 20E] 1A-1C show examples of proximal grafts with various configurations. [Figure 20F] 1A-1C show examples of proximal grafts with various configurations. [Figure 20G] 1A-1C show examples of proximal grafts with various configurations. [Figure 20H] 1A-1C show examples of proximal grafts with various configurations. [Figure 20I] 1A-1C show examples of proximal grafts with various configurations. [Figure 20J] 1A-1C show examples of proximal grafts with various configurations. [Figure 20K] 1A-1C show examples of proximal grafts with various configurations. [Figure 20L] 1A-1C show examples of proximal grafts with various configurations. [Figure 21A]1A-1C show examples of stent grafts in various configurations. [Figure 21B] 1A-1C show examples of stent grafts in various configurations. [Figure 21C] 1A-1C show examples of stent grafts in various configurations. [Figure 21D] 1A-1C show examples of stent grafts in various configurations. [Figure 22A] 1A-1C illustrate exemplary proximal extension expandable filling structures of a stent graft system in various configurations. [Figure 22B] 22A-22C are cross-sectional views of a stent-graft system (FIG. 22A) deployed across an aneurysm 14 (FIG. 1) in various configurations. [Figure 23] 1A-1C illustrate exemplary proximal extension expandable structures of a stent graft system in various configurations. DETAILED DESCRIPTION OF THE INVENTION

[0026] Various configurations are described below. It should be noted that a particular configuration is not intended to be exhaustive or a limitation on the broad range of aspects discussed herein. An aspect described with respect to a particular configuration is not necessarily limited to that configuration and can be implemented with any other configuration.

[0027] Various configurations disclosed herein relate to stent-graft systems including a single-lumen proximal graft coupled to an inflatable filling structure (e.g., an internal bag) and a limb stent-graft (rim) that can be coupled to one or more inflatable filling structures. Such stent-graft systems include one or more additional inflatable filling structures (coupled to the rim) for sac management. Sac management refers to the management of support within the aneurysm sac. The anchors (e.g., components of the stent-graft system used to secure or attach the stent-graft system to the aorta) are separate from the sealing components and from the sac management components (e.g., the inflatable filling structures), resulting in a more robust design compared to other stent-graft system designs. In some implementations, the sealing components coupled to the proximal graft are appropriately sized (e.g., by including a wide sealing ring), thereby improving placement accuracy. In some implementations, the stent-graft system includes a large, single-lumen proximal graft (e.g., having a large bore diameter) that is easier to intubate than other devices (e.g., stent-graft systems having graft components with branch lumens) and therefore requires shorter procedure and fluoroscopic times compared to other devices. Because single-lumen proximal grafts are less expensive to manufacture than grafts with branch lumens, various configurations of the stent-graft system are less expensive to manufacture compared to other devices (e.g., devices having graft components with branch lumens).

[0028] Various configurations disclosed herein include a proximal graft having a proximal suprarenal self-expanding stent with fixation features coupled to a dual-lumen polymer-filled inflatable filling structure (e.g., a dual-lumen polymer-filled internal bag). Compared to current AAA devices, the disclosed stent-graft system includes a custom neck seal and proximal fixation to the pouch management features of the stent-graft system. For example, the disclosed stent-graft system separates the proximal fixation, neck seal, cuff-to-stent-graft seal, and stent-graft-to-sac seal. Furthermore, the seal components (e.g., cuff) of such stent-graft systems are appropriately sized by having a wide sealing area below the fixation features (e.g., the anchoring stent frame), thereby improving placement accuracy. In some implementations, the individual neck seal (e.g., a custom neck seal) can generate a higher sealing pressure than that of other stent-graft system seals, allowing the neck seal to last longer.

[0029] In some cases, the higher the design requirements or functionality imposed on the design features (e.g., discrete individual components) of the stent-graft system, the less effective the design features may be. Various configurations of the stent-graft systems described herein include separate design features for fixation, sealing, and pouch management.

[0030] Some configurations of the stent-graft system include a proximal graft that is single lumen, referred to herein as a single-lumen proximal graft. The single-lumen proximal graft has a bore diameter and overall length similar to the diameter and overall length of the aortic body. The single-lumen proximal graft is a less complex structure / component and easier to manufacture than a branch lumen. The unsupported portion of the single-lumen proximal graft has a sufficient length (e.g., about 30 mm) above the limb edge (inside the single-lumen proximal graft) for emergency rescue procedures (e.g., deploying a Palmaz stent inside the single-lumen proximal graft) or for constructing from the stent-graft system 200 to treat complex AAAs and TAAs.

[0031] In some configurations, the proximal graft includes a suprarenal laser-cut stent with a coil attached. In some instances, the suprarenal stent has a shorter stent than those in some existing stent-graft systems to eliminate free crowns. A shorter stent allows for greater neck angle accommodation due to improved stent-graft flexibility. Thus, the suprarenal stent in the stent-graft systems described herein is shorter and has fewer crowns and fewer anchors, allowing the stent-graft system to be used for smaller procedure sizes. That is, the stent-graft systems described herein are low-profile delivery systems that can be used for smaller procedure sizes.

[0032] In some arrangements, the sealing component includes a wider polytetrafluoroethylene (PTFE) polymer sealing ring compared to sealing rings on other devices. The wider sealing ring improves placement accuracy, given that the wider sealing ring can provide a tight seal within the aortic neck regardless of whether the stent-graft system is placed lower than optimal (e.g., 1 mm lower). Furthermore, the wider sealing ring provides a wider treatment diameter range, i.e., fewer sealing ring sizes (and fewer stock keeping units (SKUs)) are required to treat the entire vascular treatment range. In some arrangements, the neck length of the aortic neck region into which the sealing component is configured to be deployed can be shorter than the neck length of the aortic neck region into which the sealing component of other devices is configured to be deployed. Furthermore, the wider sealing ring can improve neck angle accommodation.

[0033] In some arrangements, the proximal graft includes an inflatable filling structure (e.g., an internal bag) attached thereto. For pouch management, the inflatable filling structure is deployed to a location below (distal to) the sealing component. In some examples, the inflatable filling structure can include a dedicated filling port through which the inflatable filling structure is filled or inflated. In other examples, the inflatable filling structure and the sealing component are filled using the same filling port, thereby reducing the profile of the delivery system.

[0034] In some examples, the expandable filling structure can be made from PTFE or low-durometer polyurethane. In some cases, PTFE is used for the expandable filling structure because it can be thermally bonded to the PTFE bore of the proximal graft and / or the PTFE bore of the sealing component. In some examples, when the expandable filling structure is made from PTFE, a larger expandable filling structure is implemented because PTFE does not have a very high elasticity, which may increase the device profile. On the other hand, in some examples, when the expandable filling structure is made from polyurethane, less material is required for the expandable filling structure than for an expandable filling structure made from PTFE because polyurethane has a higher elasticity than PTFE, which can reduce the device profile. However, polyurethane cannot be easily thermally bonded to the PTFE proximal graft and / or the PTFE sealing component. Therefore, when polyurethane is used for the expandable filling structure, the polyurethane of the expandable filling structure is sutured to the PTFE proximal graft and / or the PTFE sealing component. In some cases, blood may enter the space between the bore of the proximal graft and the lumen of the expandable filling structure, thereby pressurizing the lumen.

[0035] Regarding docking, the distal-proximal graft section to which the limbs dock has a universal bore size that allows for reduction or expansion to the desired vessel size for all proximal graft sizes. In various configurations, the proximal graft is supported by a wound stent to avoid kinking the proximal graft in angular anatomical structures. In some configurations, the distal-proximal graft universal docking section is supported by a wound stent to dock the limb with sufficient radial force to minimize the possibility of disconnection between the proximal graft and limb to minimize Type III endoleaks. For unsupported proximal grafts, an inflatable filling structure (e.g., an internal bag) is used to prevent the proximal graft from collapsing, so a separate inflatable filling structure (e.g., a balloon positioned inside the proximal graft) can be used. In some cases, the balloon can be integrated with the proximal graft delivery system; i.e., the balloon can be filled using the catheter used to fill the proximal graft. Alternatively, the balloon can be filled using a catheter separate from the catheter used in the proximal graft delivery system.

[0036] In some configurations, the limbs described herein can be self-expanding PTFE-coated stents or balloon-expandable PTFE-coated stents. Self-expanding PTFE-coated stents have sufficient structural integrity (e.g., radial force) to prevent lumen collapse while the inflatable filling structure (e.g., inner bag) is being filled. On the other hand, balloon-expandable PTFE-coated stents require a balloon to expand the stent. Thus, self-expanding PTFE-coated stents have a smaller device profile compared to the device profile of balloon-expandable PTFE-coated stents.

[0037] For fixation (e.g., docking, deployment, insertion, etc.) in which a proximal graft is coupled to a rim, in some arrangements, the rim diameter of at least one rim docked or to be docked within the docking zone (or overlap zone) is smaller than the bore diameter of the proximal graft. In such instances, an expandable structure (e.g., an internal bag) around each rim inside the docking zone can seal the gutter typically present when at least one rim is docked inside a larger bore. In an alternative arrangement, the sum of the rim diameters of at least one rim docked or to be docked within the docking zone is greater than the proximal graft bore diameter. In instances in which two rims are docked within the docking zone, the cross sections of the two rims are compressed into a D-shape inside the proximal graft bore, providing joint separation resistance due to the radial force exerted by the rims against the proximal graft bore. In such an arrangement, each of the rims may include an inflatable filling structure (eg, an internal bag) within the docking zone to seal any remaining gutters.

[0038] Regarding sac management, in various configurations, the rim has an inflatable filling structure (e.g., an internal bag) attached to its PTFE-coated stent. The inflatable filling structure can cover the entire length of the rim, including the portion of the rim within the docking zone of the proximal graft. The inflatable filling structure can seal off the aneurysm sac and create a seal within the distal iliac region. In some configurations, the inflatable filling structure for the proximal graft and / or rim can be optional, depending on whether a Type II endoleak is present.

[0039] FIG. 1 is a cross-sectional view of an exemplary infrarenal aortic aneurysm 14 in a patient. Referring to FIG. 1, the aorta 10 branches into two iliac arteries 12 and 13 at an aortic bifurcation 11. The sac of the aneurysm 14 corresponds to the bulging section of the aorta 10. The infrarenal aortic aneurysm 14 is located below (distal to) the renal arteries 15 and 16. The segment of the aorta 10 between the renal arteries 15 and 16 and the sac of the aneurysm 14 is referred to as the proximal neck region 17. The proximal neck region 17 has a diameter 83 that varies among different patients. Often, a mural thrombus 18 forms on the inner wall of the sac of the aneurysm 14. In other figures, the mural thrombus 18 may be omitted for clarity.

[0040] Referring to FIG. 1 , the size of the aneurysm 14 can vary significantly from patient to patient. The diameter of the proximal neck region 17 can vary, for example, from 18 mm to 34 mm. The distance from the aortic bifurcation 11 to the renal arteries 15 and 16 can vary, for example, from 80 mm to 160 mm. The diameter of the right iliac artery 12 and the diameter of the left iliac artery 13 can be different. The diameter of the iliac arteries 12 and 13 at the aortic bifurcation 11 can vary, for example, from 8 mm to 20 mm. One or both of the iliac arteries 12 and 13 can be aneurysms with significantly enlarged diameters, for example, greater than 30 mm.

[0041] Figure 2 is a cross-sectional view of an exemplary stent-graft system 200 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1 and 2, the stent-graft system 200 may be an endovascular graft system, an infrarenal prosthesis, or the like. The stent-graft system 200 includes a proximal graft 212, a first limb stent-graft 214a, a second limb stent-graft 214b, an expandable filling structure 230, a sealing component 240, and an anchor 245.

[0042] In some arrangements, the proximal graft 212 can be a graft component made of graft material, in some cases without a stent. The proximal graft 212 has a proximal end, a distal end, and an outer surface. The proximal end of the proximal graft 212 is the end of the proximal graft 212 closer to or within the proximal neck region 17 when deployed. As shown, the proximal end of the proximal graft 212 can be positioned at the proximal neck region 17 when deployed. The distal end of the proximal graft 212 is the end of the proximal graft 212 closer to the aortic bifurcation 11 when deployed. As shown, the distal end of the proximal graft 212 can be positioned within the sac of the aneurysm 14 between the proximal neck region 17 and the aortic bifurcation 11. The outer surface of the proximal graft 212 faces the wall / surface of the aorta 10 and faces outward from the tubular lumen of the proximal graft 212.

[0043] In some arrangements, the limb stent grafts 214a and 214b may be referred to as limbs. In some instances, each of the limb stent grafts described herein (e.g., limb stent grafts 214a and 214b) includes graft material with a stent. In other instances, the limb stent graft can simply be graft material without a stent. Each of the limb stent grafts 214a and 214b can be a self-expanding PTFE-covered stent or a balloon-expandable PTFE-covered stent. Each of the first limb stent graft 214a and the second limb stent graft 214b has a proximal end, a distal end, and an outer surface. The proximal end of each limb stent graft 214a and 214b is the end of each limb stent graft 214a and 214b that is closer to the proximal neck region 17 when deployed. As shown, the proximal ends of the limb stent grafts 214a and 214b can be positioned in the sac of the aneurysm 14. The distal ends of each of the limb stent grafts 214a and 214b, when deployed, are closer to or within the iliac arteries 12 and 13. As shown, the distal end of the first limb stent graft 214a can be positioned in the iliac artery 12 when deployed, and the distal end of the second limb stent graft 214b can be positioned in the iliac artery 13 when deployed. The limb stent grafts 214a and 214b can be positioned at or adjacent to the aortic bifurcation 11. The outer surface of each of the limb stent grafts 214a and 214b faces the wall / surface of the aorta 10 and faces outward from the tubular lumen of each of the limb stent grafts 214a and 214b.

[0044] Stent-graft system 200 may be deployed across aneurysm 14 in any suitable manner. In one example, the distal ends of limb stent grafts 214a and 214b are first placed into iliac arteries 12 and 13, respectively. The distal end of proximal graft 212 is then placed over and around the proximal ends of limb stent grafts 214a and 214b such that the proximal ends of limb stent grafts 214a and 214b are inserted into the tubular lumen of the distal end of proximal graft 212. The portions of limb stent grafts 214a and 214b inserted into proximal graft 212 and the portions of proximal graft 212 surrounding limb stent grafts 214a and 214b are within docking zone 250 (the overlap zone or distal-proximal graft universal docking section where proximal graft 212 and limb stent grafts 214a and 214b overlap). Once the distal end of proximal graft 212 is positioned over limb stent grafts 214a and 214b, the proximal end of proximal graft 212 is positioned in proximal neck region 17. In this manner, proximal graft 212 can extend the aneurysm repair into proximal neck region 17.

[0045] In some examples, the expandable filling structure 230 can be made from PTFE, low durometer polyurethane, or the like. In some cases, PTFE is used for the expandable filling structure 230 because it can be thermally bonded to the PTFE bores of the proximal graft 212 and / or the PTFE bores of the sealing component 240. In some examples where the expandable filling structure 230 is made from PTFE, a larger expandable filling structure 230 may be implemented given that PTFE does not have as high a resilience, which may increase the device profile. On the other hand, in some examples where the expandable filling structure 230 is made from polyurethane, less material is required compared to the material required for an expandable filling structure 230 made from PTFE given that polyurethane has a higher resilience than PTFE. Less material can reduce the device profile. However, polyurethane cannot be easily thermally bonded to the PTFE proximal graft 212. Thus, when polyurethane is used for the expandable filling structure 230, the polyurethane of the expandable filling structure 230 is sutured to the PTFE proximal graft 212. In some cases, blood may enter the space between the bore of the proximal graft 212 and the lumen of the expandable filling structure 230, thereby pressurizing the lumen.

[0046] The expandable filling structure 230 can be filled with a filling medium using an expandable channel, filling structure, or filling line. Examples of filling medium include, but are not limited to, polyester, PTFE, polyurethane, and the like. When the expandable filling structure 230 is fully filled with a filling medium, the expandable filling structure 230 is in a filled or inflated state. When the expandable filling structure 230 is not filled with any filling medium, the expandable filling structure 230 is in an unfilled or uninflated state. In the inflated state, the expandable filling structure 230 at least partially surrounds the proximal graft 212. As shown, when deployed, the expandable filling structure 230 (in the inflated state) surrounds the portion of the proximal graft 212 that is inside the sac of the aneurysm 14 and between the lower boundary of the proximal neck region 17 and the aortic bifurcation 11. The expandable filling structure 230 (in the inflated state) does not surround any portion of the proximal graft 212 that is inside the proximal neck region 17. For pouch management, the expandable filling structure 230 is deployed to a location below (distal to) the sealing component 240. In an inflated state, the expandable filling structure 230 surrounds at least the distal end of the proximal graft 212. In various examples, the expandable filling structure 230 is an internal bag secured to a portion of the outer surface of the proximal graft 212 and includes an outer membrane that does not extend beyond the distal end of the proximal graft 212 when the expandable filling structure 230 is in an inflated state. In other words, the expandable filling structure 230 (in its inflated state) does not surround any portions of the limb stent grafts 214a and 214b that are not inserted into the proximal graft 212 when the stent graft system 200 is deployed.

[0047] The expandable filling structure 230 is secured to the above-mentioned portion of the outer surface of the proximal graft 212 when the proximal graft 212 is positioned over the limb stent grafts 214a and 214b and is initially in an uninflated state. The expandable filling structure 230 is then filled with a filling medium to reach an inflated state. As the expandable filling structure 230 is filled, a portion thereof extends and expands radially into the sac space of the aneurysm 14 adjacent the proximal graft 212. When in the uninflated state, the expandable filling structure 230 can be confined around the proximal graft 212; when in the inflated state as shown, the expandable filling structure 230 expands radially and proximally to fill all (or most) of the aneurysm 14 between the distal end of the proximal graft 212 and the lower boundary of the proximal neck region 17. The filling medium presses its wall (e.g., adventitia) against the wall / surface of the aneurysm 14 when the expandable filling structure 230 is in the filled state. When the expandable filling structure 230 is in the filled state, the expandable filling structure 230 conforms to the wall / surface of the aneurysm 14 and a portion of the outer surface of the proximal graft 212 .

[0048] The proximal graft 212 and limb stent grafts 214a and 214b are separate grafts (pre-deployment) that are connected, joined, or otherwise joined together when deployed in the described manner. The proximal graft 212 and limb stent grafts 214a and 214b are each single-lumen grafts. Single-lumen grafts are less complex structures / components and are easier and less expensive to manufacture than branched lumen grafts. In some implementations, the proximal graft 212 has a larger bore diameter that makes it easier to intubate than other devices that use grafts with branched lumens, thus requiring shorter procedure and delivery times compared to such other devices. The single-lumen proximal graft 212 has a bore diameter and overall length similar to the diameter and overall length of the aorta 10, respectively. The unsupported portion of the single-lumen proximal graft 212 refers to the portion of the single-lumen proximal graft 212 that has graft material (e.g., PTFE) without a stent for structural support. The unsupported portion of the single lumen proximal graft 212 (which is outside the docking zone 250 when deployed in the described manner and is above and proximal to the proximal edges / ends of the limb stent grafts 214a and 214b inside the single lumen proximal graft 212) has a length (e.g., approximately 30 mm) sufficient for emergency rescue procedures (such as, but not limited to, deploying a Palmaz stent inside the single lumen proximal graft) or for constructing from the stent graft system 200 to treat complex AAAs and TAAs.

[0049] In various configurations, the anchors 245 (such as anchoring features and anchoring stent frames) anchor, secure, or attach the proximal end of the stent-graft system 200 (e.g., the proximal graft 212) to the wall / surface of the aorta 10, preventing blood from entering the area between the outer and inner walls of the aneurysm 14 and improving the transition from the aorta 10 into the tubular lumen of the proximal graft 212. In some examples, the anchors 245 can include stents, grafts, and / or other expandable luminal support structures. In some examples, the anchors 245 include suprarenal laser-cut stents with attached coils. In some examples, the anchors 245 have shorter stents than those of some existing stent-graft systems to eliminate free crowns. A shorter stent allows for greater neck angle accommodation due to improved stent-graft flexibility. Thus, the suprarenal stents of the anchors 245 have shorter lengths and fewer crowns and anchors, allowing the stent-graft system 200 to be used for smaller procedure sizes. That is, the stent graft system 200 is a low profile delivery system that can be used for small procedure sizes.

[0050] In some examples, the anchor 245 is a stent-like skeletal structure that can be implanted within the upper proximal opening of the tubular lumen or tubular end of the proximal end of the proximal graft 212. As shown, the anchor 245 extends proximally from the proximal end of the proximal graft 212. When deployed, the anchor 245 can extend from a location inside or on the border of the proximal neck region 17 across the openings to the renal arteries 15 and 16 (e.g., the renal ostium). The anchor 245 includes hooks or barbs that anchor, secure, or attach to the wall / surface of the aorta 10 proximal to the renal ostium and proximal neck region 17. The anchor 245 includes openings or ports to allow blood flow into the renal arteries 15 and 16. As shown, given that the anchor 245 has a stent-like skeletal structure, blood can flow into the renal arteries 15 and 16 through the unobstructed renal ostium.

[0051] Each of the grafts 212, 214a, and 214b can include one or more fill lines or expandable channels that communicate a hardenable expansion material or filler polymer in liquid form. In some arrangements, each of the grafts 212, 214a, and 214b can include one or more circumferential expandable channels that can extend or partially extend around the circumference of the graft body. In some implementations, the expandable channels can be in fluid communication with one another through longitudinal expandable fill channels within the graft body. The network of expandable channels can be filled with a hardenable material that hardens, solidifies, or otherwise becomes more viscous or firmer after being injected into the channels. A hardenable expansion material, such as a gel, liquid, or other flowable material that can set to a more solid or substantially hardened state, can be used to provide mechanical support to the graft body of each of the grafts 212, 214a, and 214b due to the mechanical properties of the hardened material disposed within the channels. In some arrangements, the filler is a saline solution. In some arrangements, the filler is a gas.

[0052] In some implementations, the sealing component 240 (e.g., a cuff, a separate neck seal, a custom neck seal, etc.) can be an inflatable sealing ring. The sealing component 240 accommodates various sizes of the aorta 10, for example, particularly various sizes of the proximal neck region 17. In some examples, as shown in FIG. 2 , the sealing component 240 continuously contacts the inner wall of the proximal neck region 17 and provides a continuous seal with the proximal neck region 17 while in an inflated state. Continuous contact with the inner wall of the proximal neck region 17 means that the sealing component 240 fully contacts the inner wall when in an inflated state to form a fluid seal therewith, or that the entire inner wall is continuously contacted without any portion of the sealing component 240 not contacting the inner wall of the proximal neck region 17.

[0053] In some implementations, the seal component 240 is coupled to the proximal graft 212. For example, the seal component 240 is attached, secured, or otherwise coupled to an outer surface of the proximal graft 212. In the expanded state, the seal component 240 surrounds a portion of the proximal graft 212 in the proximal neck region 17 when the proximal graft 212 is deployed. The seal component 240 is positioned at or near the proximal end of the proximal graft 212. In some examples, the seal component 240 does not reach or extend beyond the edge of the proximal end of the proximal graft 212 when in the expanded state, such that portions of the proximal graft 212 adjacent the edge of the proximal end of the proximal graft 212 are not surrounded by the seal component 240. In other examples, the seal component 240 reaches or extends beyond the edge of the proximal end of the proximal graft 212 when in the expanded state.

[0054] Graft materials used in stent-graft system 200 include, but are not limited to, polyester, PTFE, polyurethane, and the like. In some arrangements, each of grafts 212, 214a, and 214b is a stent covered with a graft material. In some arrangements, seal component 240 has or is in communication with a fill line or inflatable channel that communicates a hardenable expansion material or filled polymer (e.g., polyester, PTFE, polyurethane, etc.) in liquid form.

[0055] In some examples, sealing component 240 uses inflatable channels and fill ports that are different from those used by the rest of stent-graft system 200. That is, sealing component 240 does not share inflatable channels or fill ports with other components (e.g., grafts 212, 214a, and 214b, and inflatable filling structure 230, etc.). Thus, when stent-graft system 200 is deployed, at least a first inflatable channel coupled to inflatable filling structure 230 and a first fill port on inflatable filling structure 230 are used to inject filling polymer into inflatable filling structure 230, and a second inflatable channel coupled to sealing component 240 and a second fill port on sealing component 240 are used to fill sealing component 240 with filling polymer.

[0056] In some instances where the sealing component 240 is inflated using a dedicated inflatable channel that is not shared with another component of the stent-graft system 200 (e.g., the inflatable filling structure 230), the sealing component 240 can be inflated (using a dedicated inflatable channel) to or with a higher pressure than the pressure to which the inflatable filling structure 230 is filled using its inflatable channel. In some instances, the inflatable filling structure 230 is inflated to or with a lower pressure (e.g., about 120-180 mmHg) that may not be sufficient to adequately inflate the sealing component 240. The sealing component 240 is filled to or with a higher pressure (180-760 mmHg) to prevent the inflatable filling structure 230 from dislodging into the renal arteries 15 and 16 as it is being inflated. In this case, the sealing component 240 is inflated before the inflatable filling structure 230 is inflated. The seal component 240, which is filled to a higher pressure to form a seal in the proximal neck region 17, acts like a stopper to prevent the expandable filling structure 230 from escaping through the proximal neck region 17 and into the renal arteries 15 and 16. Furthermore, the seal component 240 can fill at a higher pressure by contacting normal tissue, which has the ability to accommodate higher pressures for sealing and locking purposes, whereas the expandable filling structure 230 contacts the aneurysmal sac (bad tissue) and therefore must fill at a lower pressure.

[0057] In other examples, the sealing component 240 may use an inflatable channel and a fill port that is also used by another component (e.g., the inflatable filling structure 230 of the stent-graft system 200). That is, the sealing component 240 shares an inflatable channel and a fill port with another component (e.g., the inflatable filling structure 230) of the stent-graft system 200. When the inflatable channel and the fill port are shared, the device profile and the profile of the delivery system may be reduced.

[0058] In some arrangements, the sealing component 240 is a wide PTFE polymer sealing ring. The PTFE polymer sealing ring of the sealing component 240 is wider compared to sealing rings on other devices. In one example, the sealing component 240 in an inflated state and deployed entirely within the proximal neck region 17 is at least 10 mm wide along the longitudinal dimension of the aorta 10 (e.g., in a proximal-distal direction). The wider sealing ring improves placement accuracy, given that even if the stent-graft system 200 (e.g., the proximal graft 212 and the sealing component 240) is positioned lower (e.g., 1 mm lower) than the optimal position, the wider sealing ring of the sealing component 240 can still provide a sufficiently tight seal within the proximal neck region 17. The optimal position corresponds to a position of the stent-graft system 200 that allows the sealing component 240 (in an inflated state) to be entirely within the proximal neck region 17 (and not within the sac of the aneurysm 14) when the stent-graft system 200 is deployed in the described manner. Given that the width / radius of the sac of the aneurysm 14 is greater than the width / radius of the proximal neck region 17, the portion of the sealing component 240 outside the proximal neck region 17 is unable to form a tight seal relative to the sac wall. Because the sealing component 240 includes a wide sealing ring, the portion of the sealing component 240 outside the proximal neck region 17 and inside the sac of the aneurysm 14 is unable to form a tight seal; however, even if the stent-graft system 200 (e.g., the proximal graft 212 and the sealing component 240) is positioned lower than optimally, most of the sealing component 240 is still inside the proximal neck region 17. The portion of the sealing component 240 inside the proximal neck region 17 can still provide a sufficiently tight seal. Therefore, this positioning can be considered accurate, since the sealing component 240 can still provide a sufficiently tight seal regardless, even if the stent-graft system 200 is positioned lower than optimally.

[0059] Furthermore, the wider sealing rings of the sealing component 240 have a wider treatment diameter range. Therefore, fewer different treatment diameter ranges of the wider sealing rings are required. This means that fewer sealing ring sizes and corresponding SKUs are required to treat the entire vascular treatment range (e.g., to accommodate patients with proximal neck regions 17 of various sizes). In one example, once the sealing component 240 radially expands (during filling) to the point where it contacts the inner wall of the proximal neck region 17, the sealing component 240 then expands longitudinally within the proximal neck region 17. This allows the sealing component 240 to accommodate a larger range of vessel sizes. Therefore, fewer sizes of the sealing component 240 need to be manufactured, improving flexibility and cost. Furthermore, the wider sealing rings can improve neck angle accommodation.

[0060] As shown, anchor 245 (for anchoring or attachment to aorta 10), sealing component 240 (for sealing proximal neck region 17), and expandable filling structure 230 (for sac management) are separate components. That is, anchor 245, sealing component 240, and expandable filling structure 230 each have a single function, which results in a more robust design compared to other stent-graft system designs.

[0061] Figure 3A is a cross-sectional view of an exemplary stent-graft system 300 deployed across an aneurysm 14 (Figure 1) in various configurations. Figure 3B is another cross-sectional view of an exemplary stent-graft system 300 (Figure 3A) deployed across an aneurysm 14 (Figure 1) in various configurations. Referring to Figures 1-3B, stent-graft system 300 includes a proximal graft 212, a first limb stent-graft 214a, a second limb stent-graft 214b, an expandable filling structure 330, a sealing component 240, and an anchor 245. Proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, sealing component 240, and anchor 245 are components of stent-graft system 300 that are similar to the corresponding components of stent-graft system 200 and offer similar improvements over these components. Additionally, once deployed within the aorta 10, the first and second limb stent grafts 214a, 214b may dock within the proximal graft 212 (e.g., within docking zone 250) in a manner to be described. As shown, Figure 3B is a cross-sectional view of the stent graft system 300 taken within the docking zone 250 shown in Figure 3A.

[0062] In some instances, the rim diameter of the first limb stent graft 214a and the rim diameter of the second limb stent graft 214b (within the docking zone 250) are substantially smaller than the bore diameter of the lumen of the proximal graft 212. Typically, in such instances, a groove 302 appears within the docking zone 250 when the limb stent grafts 214a and 214b are docked into the larger bore of the proximal graft 212. The expandable filling structure 330 is shaped to seal such groove 302. The expandable filling structure 330 is similar to the expandable filling structure 230, except that when deployed, it extends into the sac of the aneurysm 14 and is shaped to surround each of the limb stent grafts 214a and 214b (including the portions of the limb stent grafts 214a and 214b that are outside the docking zone 250). The expandable filling structure 330 is filled by the filling line 301 after the limb stent grafts 214a and 214b are docked inside the single lumen of the proximal graft 212. As shown, when filled to an expanded state, the expandable filling structure 330, which is anchored, bonded, attached or otherwise coupled to the outer surface of the proximal graft 212, can extend distally toward the iliac arteries 12 and 13 and the aortic bifurcation 11 to surround the limb stent grafts 214a and 214b while simultaneously radially compressing the face / wall of the sac of the aneurysm 14. The limb stent grafts 214a and 214b do not have any expandable filling structures anchored, bonded, attached or otherwise coupled thereto. The expandable filling structure 330 can thus close the gutter 302 (by surrounding the limb stent grafts 214a and 214b) and fill the aneurysm sac from the proximal neck region 17 to the aortic bifurcation 11. In some examples (not shown), the expandable filling structure 330 can even extend into the iliac arteries 12 and 13, surrounding the portions of the limb stent grafts 214a and 214b that are inside the iliac arteries 12 and 13. Thus, only one component (the expandable filling structure 330), one filling line (the filling line 301), and one filling operation are required to seal the entire sac of the aneurysm 14, including the gutter 302 and sometimes even the iliac arteries 12 and 13, resulting in shorter procedure times.The cost of the stent graft system 300 is also lower given that the limb stent grafts 214a and 214b do not have any inflatable filling structures.

[0063] Figure 4A is a cross-sectional view of an exemplary stent-graft system 400 deployed across an aneurysm 14 (Figure 1) in various configurations. Figure 4B is another cross-sectional view of an exemplary stent-graft system 400 (Figure 4A) deployed across an aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 4A-4B, stent-graft system 400 includes proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, expandable filling structures 430, 432, and 434, and anchor 245. Proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, and anchor 245 are components of stent-graft system 400 that are similar to the corresponding components of stent-graft system 200 and offer similar improvements over these components. Additionally, once deployed within the aorta 10, the first and second limb stent grafts 214a, 214b may dock within the proximal graft 212 (e.g., within the docking zone 250) in a manner to be described. As shown, Figure 4B is a cross-sectional view of the stent graft system 400 taken within the docking zone 250 shown in Figure 4A.

[0064] The expandable filling structure 430 is secured, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212. In some examples, the expandable filling structure 430 is secured, bonded, attached, or otherwise coupled to the entire outer surface of the proximal graft 212 except for a portion of the outer surface of the proximal graft 212 adjacent the edge of the proximal end of the proximal graft 212. In other examples, the expandable filling structure 430 is secured, bonded, attached, or otherwise coupled to the entire outer surface of the proximal graft 212. In some examples, in the expanded state, the expandable filling structure 430 surrounds the outer surface of the proximal graft 212 (deployed within the aorta 10), including the proximal neck region 17 and the portion of the proximal graft 212 within the sac of the aneurysm 14. Thus, the stent-graft system 400 differs from the stent-graft system 200 in that it does not include a separate sealing component (e.g., sealing component 240). Instead, the expandable filling structure 430 can provide a seal inside the proximal neck region 17 (below or distal to the renal arteries 15 and 16). Given that a separate sealing component is not provided and that the same component (e.g., the expandable filling structure 430) provides both the sealing and pouch management functions, the stent-graft system 400 is less complex and therefore easier and less expensive to manufacture.

[0065] Additionally, expandable filling structure 432 is secured, bonded, attached, or otherwise coupled to the outer surface of limb stent graft 214a. Expandable filling structure 434 is secured, bonded, attached, or otherwise coupled to the outer surface of limb stent graft 214b. Each of expandable filling structures 432 and 434 can be inflated using a dedicated filling line or using a filling line shared with another component of stent graft system 400. Upon inflation, expandable filling structures 432 and 434 expand radially from limb stent grafts 214a and 214b toward the face / wall of the sac of aneurysm 14. In the inflated state, expandable filling structures 432 and 434 surround limb stent grafts 214a and 214b, respectively. As shown, expandable filling structure 430 expands in and fills the upper or proximal portion of the sac of aneurysm 14, while expandable filling structures 432 and 434 expand in and fill the bottom or distal portion of the sac. Thus, the entire volume of the sac is filled by the combination of expandable filling structures 430, 432, and 434.

[0066] In some examples, the expandable filling structure 432 is secured, bonded, attached, or otherwise coupled to a portion (but not the entire) of the outer surface of the limb stent graft 214a. The expandable filling structure 432 (when inflated) surrounds a portion (but not the entire) of the outer surface of the limb stent graft 214a. For example, as shown, the expandable filling structure 432 (in its expanded state) surrounds an intermediate portion of the limb stent graft 214a between the proximal end (the portion that is inside the docking zone 250 when deployed) and the distal end (the portion that is inside the iliac arteries 12 when deployed). Thus, the expandable filling structure 432 is not secured, bonded, attached, or otherwise coupled to and does not surround the portion of the limb stent graft 214a inserted within the docking zone 250 and the portion of the limb stent graft 214a disposed in the iliac arteries 12. With respect to the limb stent graft 214b, the expandable filling structure 434 is similar to the expandable filling structure 432.

[0067] In some instances, the expandable filling structures 432 and 434 do not expand into the lumen of the proximal graft 212 within the docking zone 250 to seal the gutter 302. If the expandable filling structures 432 and 434 expand into the lumen of the proximal graft 212, the limb stent grafts 214a and 214b (after docking) can exit the proximal graft 212 distally down toward the aortic bifurcation 11 while the expandable filling structures 432 and 434 are inflated. The gutter 302 (inside the lumen of the proximal graft 212) can be closed / sealed by the inflated expandable filling structure 430 after the limb stent grafts 214a and 214b are deployed inside the proximal graft 212. In other words, the expandable filling structure 430 (in its inflated state) fills and seals the gutter 302 inside the lumen of the proximal graft 212. In this way, the proximal graft filling lumen remains docked while the proximal graft catheter is removed to deploy the ipsilateral limb stent grafts 214 a and 214 b. In some arrangements, the portion of the proximal graft 212 inside the docking zone 250 is an unsupported graft (e.g., PTFE without a stent) to fit around the limb stent grafts 214 a and 214 b when they are docked inside the proximal graft 212.

[0068] Figure 5 is a cross-sectional view of an exemplary stent-graft system 500 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, 4A-4B, and 5, stent-graft system 500 includes proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, expandable filling structure 430, expandable filling structures 532 and 534, and anchor 245 (not shown for clarity). Proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, expandable filling structure 430, and anchor 245 are components of stent-graft system 400 that are similar to the corresponding components of stent-graft systems 200 and 400 and offer similar improvements over these components. Additionally, once deployed within the aorta 10, the first limb stent graft 214a and the second limb stent graft 214b may dock within the proximal graft 212 (eg, within the docking zone 250) in a manner to be described.

[0069] In some examples, the expandable filling structure 532 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of the limb stent graft 214a. The expandable filling structure 534 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of the limb stent graft 214b. Thus, the expandable filling structures 532 and 534 are fixed, bonded, attached, or otherwise coupled to and, in their expanded state, surround the portions of the limb stent grafts 214a and 214b inserted within the docking zone 250 and the portions of the limb stent grafts 214a and 214b positioned in the iliac arteries 12, in addition to the intermediate portions.

[0070] Each of the expandable filling structures 532 and 534 can be inflated using a dedicated filling line or using a filling line shared with another component of the stent-graft system 500. Upon inflation, the expandable filling structures 532 and 534 expand radially from the limb stent-grafts 214a and 214b toward the face / wall of the sac of the aneurysm 14. In the inflated state, the expandable filling structures 532 and 534 surround the limb stent-grafts 214a and 214b, respectively. As shown, the expandable filling structure 430 expands in and fills the upper or proximal portion of the sac of the aneurysm 14, while the expandable filling structures 532 and 534 expand in and fills the bottom or distal portion of the sac. Thus, the entire volume of the sac is filled by the combination of the expandable filling structures 420, 532, and 534.

[0071] In some instances, the expandable filling structures 532 and 534 expand into the lumen of the proximal graft 212 within the docking zone 250 and seal the gutter within the docking zone 250. In such an arrangement, the expandable filling structure 430 can be filled in the manner described, and the delivery system for the proximal graft 212 and the expandable filling structure 430 can be removed before deploying the limb stent grafts 214a and 214b and inflating the expandable filling structures 532 and 534, thus unfolding the deployment actuation.

[0072] Figure 6A is a cross-sectional view of an exemplary stent-graft system 600 deployed across an aneurysm 14 (Figure 1) in various configurations. Figure 6B is another cross-sectional view of an exemplary stent-graft system 600 (Figure 6A) deployed across an aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 6A-6B, stent-graft system 600 includes proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, expandable filling structure 630, and anchor 245. Proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, and anchor 245 are components of stent-graft system 600 that are similar to corresponding components of stent-graft system 200 and offer similar improvements over these components. Additionally, once deployed within the aorta 10, the first and second limb stent grafts 214a, 214b may dock within the proximal graft 212 (e.g., within the docking zone 250) in a manner to be described. As shown, Figure 6B is a cross-sectional view of the stent graft system 600 taken within the docking zone 250 shown in Figure 6A.

[0073] The expandable filling structure 630 is secured, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212. In some examples, the expandable filling structure 630 is secured, bonded, attached, or otherwise coupled to the entire outer surface of the proximal graft 212 except for a portion of the outer surface of the proximal graft 212 adjacent the edge of the proximal end of the proximal graft 212. In other examples, the expandable filling structure 630 is secured, bonded, attached, or otherwise coupled to the entire outer surface of the proximal graft 212. In some examples, in the expanded state, the expandable filling structure 630 surrounds the outer surface of the proximal graft 212 (deployed within the aorta 10), including the proximal neck region 17 and the portion of the proximal graft 212 within the sac of the aneurysm 14. Thus, the stent-graft system 600 differs from the stent-graft system 200 in that it does not include a separate sealing component (e.g., sealing component 240). Instead, the expandable filling structure 630 can provide a seal inside the proximal neck region 17 (below or distal to the renal arteries 15 and 16).

[0074] Additionally, the expandable filling structure 630 is shaped to seal the gutter 302. The expandable filling structure 630 is shaped to extend into the sac of the aneurysm 14 when deployed and surround each of the limb stent grafts 214a and 214b (including the portions of the limb stent grafts 214a and 214b outside of the docking zone 250). The expandable filling structure 630 is filled by the filling line 601 after the limb stent grafts 214a and 214b are docked inside the single lumen of the proximal graft 212. As shown, when filled to its expanded state, the expandable filling structure 630, which is secured, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212, can extend distally toward the iliac arteries 12 and 13 and the aortic bifurcation 11 to surround the limb stent grafts 214a and 214b, while simultaneously radially compressing the face / wall of the sac of the aneurysm 14. The limb stent grafts 214a and 214b do not have any inflatable filling structures secured, joined, attached, or otherwise connected thereto. Thus, the inflatable filling structure 630 can close the gutter 302 (by surrounding the limb stent grafts 214a and 214b) and fill the aneurysm sac from the proximal neck region 17 to the aortic bifurcation 11. In some examples (not shown), the inflatable filling structure 630 may even extend into the iliac arteries 12 and 13, surrounding the portions of the limb stent grafts 214a and 214b that are inside the iliac arteries 12 and 13.

[0075] Thus, only one component (inflatable filling structure 630) is required to seal the entire sac of the aneurysm 14, including the gutter 302, the proximal neck region 17, and sometimes even the iliac arteries 12 and 13, and only one filling line (filling line 601) and one filling operation are required to perform both the sealing and sac management functions, resulting in shorter procedure times. The complexity and cost of the stent graft system 600 is also lower, given that the limb stent grafts 214a and 214b do not have any inflatable filling structures.

[0076] Figure 7 is a cross-sectional view of an exemplary stent-graft system 700 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 7, the stent-graft system 700 includes a proximal graft 212, a first limb stent-graft 214a, a second limb stent-graft 214b, a sealing component 240, anchors 245, and a support component 702. The proximal graft 212, the first limb stent-graft 214a, the second limb stent-graft 214b, the sealing component 240, and the anchors 245 are components of the stent-graft system 700 that are similar to the corresponding components of the stent-graft system 200 and offer similar improvements over these components. Additionally, once deployed within the aorta 10, the first limb stent graft 214a and the second limb stent graft 214b may dock within the proximal graft 212 (eg, within the docking zone 250) in a manner to be described.

[0077] The unsupported section 704 of the proximal graft 212 comprises a graft material (e.g., PTFE) without a stent for structural support. The unsupported section 704 is configured for proximal extension; that is, the unsupported section 704 extends into the proximal neck region 17 when the proximal graft 212 is placed in the aorta 10 in the described manner. The seal component 240 is attached, secured, or otherwise coupled to the outer surface of the unsupported section 704 of the proximal graft 212.

[0078] In some arrangements, the support component 702 is a support ring or support balloon made from a polymer (e.g., PTFE, polyurethane, etc.). The support component 702 surrounds the portion of the proximal graft 212 within the docking zone 250. In other words, the support component 702 is attached, secured, bonded (e.g., thermally bonded) to the proximal graft 212 on the outer surface of the proximal graft 212. In some examples, the portion surrounding the portion of the proximal graft 212 within the docking zone 250 is unsupported. In some examples, the entire proximal graft 212 (including the docking zone 250 and the unsupported section 704) is unsupported. The support component 702 can facilitate intubation of the proximal graft 212 before or while an inflatable filling structure (not shown) of the proximal graft 212 is filled through an appropriate filling line. Such an inflatable filling structure can be secured, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212. In some examples, in an expanded state, such an expandable filling structure surrounds the exterior of the proximal graft 212 (deployed within the aorta 10), including one or more of the portion of the proximal graft 212 within the proximal neck region 17, the portion of the proximal graft 212 within the sac of the aneurysm 14, the gutter, and the like. The support component 702 can be a supporting expandable filling structure that is expanded to provide structural integrity to an unsupported proximal graft 212 (e.g., the portion within the docking zone 250) before or while the expandable filling structure is expanded. The support component 702 provides structural integrity by preventing collapse of the proximal graft 212 in the expanded state. In some examples, the support component 702 can be integrated with a delivery system that delivers the proximal graft 212. That is, the support component 702 can be filled using the catheter (shared filling line) used to fill the proximal graft 212. Alternatively, the support component 702 can be filled using a catheter separate from the catheter used in the delivery system for the proximal graft 212. The support component 702 does not increase the device profile.

[0079] Figure 8 is a cross-sectional view of an exemplary stent-graft system 800 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, 7, and 8, stent-graft system 800 includes proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, sealing component 240, and anchor 245. Proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, sealing component 240, and anchor 245 are components of stent-graft system 800 that are similar to the corresponding components of stent-graft system 200 and offer similar improvements over these components. Additionally, once deployed within the aorta 10, the first and second limb stent grafts 214a, 214b can dock within the proximal graft 212 (e.g., within the docking zone 250) in a manner to be described. As described above, the unsupported section 704 of the proximal graft 212 comprises a graft material (e.g., PTFE) without a stent for structural support. In some instances, other portions of the proximal graft 212 can be unsupported in addition to the unsupported section 704. In some instances, the entire proximal graft 212 is unsupported. The seal component 240 is attached, secured, or otherwise coupled to the outer surface of the unsupported section 704 of the proximal graft 212.

[0080] In some arrangements, the proximal graft 212 includes a wound stent component 802 embedded therein. In some examples, the wound stent component 802 includes a wound stent (multiple wound rings) and does not have any graft material attached thereto such that the lumen of the proximal graft 212 is open at the location of the wound stent component 802 for easy cannulation. In other examples, the wound stent component 802 has graft material attached thereto. In some examples, the wound stent component 802 is positioned at the distal end of the proximal graft 212. In some examples, the wound stent component 802 is positioned within the docking zone 250 of the proximal graft 212.

[0081] The wound stent component 802 can facilitate cannulation of the proximal graft 212 before or while its expandable filling structure (not shown) is filled through an appropriate filling line. Such an expandable filling structure can be secured, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212. In some examples, in an expanded state, such an expandable filling structure surrounds the outer surface of the proximal graft 212 (deployed within the aorta 10), including one or more of the portion of the proximal graft 212 within the proximal neck region 17, the portion of the proximal graft 212 within the sac of the aneurysm 14, a gutter, and the like. The wound stent component 802 can provide structural integrity to the proximal graft 212 before or while the expandable filling structure is expanded. The wound stent component 802 provides structural integrity by preventing collapse of the proximal graft 212 and avoiding kinking of the lumen of the proximal graft 212 within angular anatomy. The wound stent component 802 allows for improved mechanical locking between the proximal graft 212 and the limb stent grafts 214a and 214b at the docking zone 250 by providing sufficient radial force to minimize the likelihood of disconnection between the proximal graft 212 and the limb stent grafts 214a and 214b, thereby improving joint separation resistance and minimizing Type III endoleaks.

[0082] Figure 9 is a cross-sectional view of an exemplary stent-graft system 900 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 7-9, the stent-graft system 900 includes a proximal graft 212, a first limb stent-graft 214a, a second limb stent-graft 214b, a sealing component 240, and an anchor 245. The proximal graft 212, the first limb stent-graft 214a, the second limb stent-graft 214b, the sealing component 240, and the anchor 245 are components of the stent-graft system 900 that are similar to the corresponding components of the stent-graft system 200 and offer similar improvements over these components. Additionally, once deployed within the aorta 10, the first and second limb stent grafts 214a, 214b can dock within the proximal graft 212 (e.g., within the docking zone 250) in a manner to be described. As described above, the unsupported section 704 of the proximal graft 212 comprises a graft material (e.g., PTFE) without a stent for structural support. In some instances, other portions of the proximal graft 212 can be unsupported in addition to the unsupported section 704. In some instances, the entire proximal graft 212 is unsupported. The seal component 240 is attached, secured, or otherwise coupled to the outer surface of the unsupported section 704 of the proximal graft 212.

[0083] In some arrangements, the proximal graft 212 includes a wound stent ring 902 embedded therein. In some instances, the wound stent ring 902 includes a single wound stent ring and does not have any graft material attached thereto such that the lumen of the proximal graft 212 is open at the location of the wound stent component 902 for easy cannulation. In other instances, the wound stent ring 902 has graft material attached thereto. In some instances, the wound stent ring 902 is positioned at the distal end of the proximal graft 212 and abuts the edge of the proximal graft 212. In some instances, the wound stent ring 902 is positioned within the docking zone 250 of the proximal graft 212.

[0084] The wound stent ring 902 can facilitate cannulation of the proximal graft 212 before or while its expandable filling structure (not shown) is filled through an appropriate filling line. Such an expandable filling structure can be secured, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212. In some examples, in an expanded state, such an expandable filling structure surrounds the outer surface of the proximal graft 212 (deployed within the aorta 10), including one or more of the portion of the proximal graft 212 within the proximal neck region 17, the portion of the proximal graft 212 within the sac of the aneurysm 14, a gutter, and the like. The wound stent ring 902 can provide structural integrity to the proximal graft 212 before or while the expandable filling structure is expanded. The wound stent ring 902 provides structural integrity by preventing collapse of the proximal graft 212 and avoiding kinking of the lumen of the proximal graft 212 within angular anatomy. The wound stent ring 902 allows for improved mechanical locking between the proximal graft 212 and the limb stent grafts 214a and 214b at the docking zone 250 by providing sufficient radial force to minimize the likelihood of disconnection between the proximal graft 212 and the limb stent grafts 214a and 214b, thereby improving joint separation resistance and minimizing Type III endoleaks.

[0085] Figure 10 is a cross-sectional view of an exemplary stent-graft system 1000 deployed across an aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 10, stent-graft system 1000 includes proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, sealing component 1240, anchor 245, expandable filling structure 1002, and expandable filling structure 1004. Proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, and anchor 245 are components of stent-graft system 1000 that are similar to the corresponding components of stent-graft system 200 and offer similar improvements over these components. In some arrangements, sealing component 1240 is similar to sealing component 240 except that it is wider, such that a portion thereof extends outside of proximal neck region 17 and inside the sac of aneurysm 14. When deployed within aorta 10, first limb stent graft 214a and second limb stent graft 214b can dock within proximal graft 212 (e.g., within docking zone 250) in the described manner. In some examples, the portion of proximal graft 212 within docking zone 250 includes a wound stent ring 902. In some examples, wound stent ring 902 includes a single wound stent ring and does not have any graft material attached thereto, such that the lumen of proximal graft 212 is open at the location of wound stent component 902 for easy cannulation.

[0086] In some arrangements, each of the limb stent grafts 214a and 214b includes a wound stent component 1012 and 1014, respectively, embedded therein. In some instances, each of the wound stent components 1012 and 1014 includes a wound stent (comprising multiple wound rings) and does not have any graft material attached thereto such that the lumen of each of the limb stent grafts 214a and 214b is open at the location of the respective wound stent component 1012 and 1014 for easy cannulation. In other instances, the wound stent components 1012 and 1014 have graft material attached thereto. In some instances, each of the wound stent components 1012 and 1014 is positioned at the distal end of the respective limb stent grafts 214a and 214b and is positioned in the iliac arteries 12 and 13 when deployed.

[0087] The expandable filling structure 1002 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of the limb stent graft 214a. The expandable filling structure 1004 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of the limb stent graft 214b. Each of the expandable filling structures 1002 and 1004 can be inflated using a dedicated filling line or using a filling line shared with another component of the stent graft system 1000. Upon inflation, the expandable filling structures 1002 and 1004 expand radially from the limb stent grafts 214a and 214b toward the face / wall of the sac of the aneurysm 14. In the expanded state, the expandable filling structures 1002 and 1004 surround the limb stent grafts 214a and 214b, respectively.

[0088] In some instances, the expandable filling structure 1002 is anchored, bonded, attached, or otherwise coupled to a portion (but not the entire) of the outer surface of the limb stent graft 214a. The expandable filling structure 1002 (when expanded) surrounds a portion (but not the entire) of the outer surface of the limb stent graft 214a. In some arrangements, the expandable filling structure 1002 is not anchored, bonded, attached, or otherwise coupled to and does not surround the portions of the proximal graft 214a that will be positioned in the iliac arteries 12 when deployed, or the portions of the limb stent graft 214a that correspond to the wound stent components 1012 and 1014. In other arrangements, the expandable filling structure 1002 is anchored, bonded, attached, or otherwise coupled to and surrounds the portions of the proximal graft 214a that will be positioned in the iliac arteries 12 when deployed, or the portions of the limb stent graft 214a that correspond to the wound stent components 1012 and 1014. With respect to limb stent graft 214b, expandable filling structure 1004 is similar to expandable filling structure 1002. In some arrangements, expandable filling structures 1002 and 1004 are not fixed, joined, attached, or otherwise coupled to and do not surround portions of respective limb stent grafts 214a and 214b inserted into docking zone 250. In some instances, expandable filling structures 1002 and 1004 surround stent grafts 214a and 214b outside of docking zone 250 and contact the edge of the distal end of proximal graft 212 to seal the gutter. In some instances, expandable filling structures 1002 and 1004 expand into the lumen of proximal graft 212 within docking zone 250 to seal the gutter.

[0089] Additionally, the expandable filling structures 1002 and 1004 are shaped to extend into the sac of the aneurysm 14 and surround the portion of the proximal graft 212 within the sac when deployed. As shown, while filled in the expanded state, the expandable filling structures 1002 and 1004 extend proximally toward the proximal neck region 17 to surround the proximal graft 212, and can simultaneously radially compress the face / wall of the sac of the aneurysm 14. The proximal graft 212 does not have any expandable filling structures secured, bonded, attached, or otherwise connected to it. Given that no expandable filling structures are provided for the stent-graft, the stent-graft system 1000 is less expensive to manufacture. As shown, the entire volume of the sac is correspondingly filled by the expandable filling structures 1002 and 1004.

[0090] In some cases, instead of two expandable filling structures 1002 and 1004, a single expandable filling structure fixed, joined, attached or otherwise coupled to either one or both of the limb stent grafts 214a and 214b can be used to surround the limb stent grafts 214a and 214b and further extend into the sac of the aneurysm 14 to surround the portion of the proximal graft 212 within the sac when deployed.

[0091] Figure 11A is a cross-sectional view of an exemplary stent-graft system 1100 deployed across an aneurysm 14 (Figure 1) in various configurations. Figure 11B is another cross-sectional view of an exemplary stent-graft system 1100 (Figure 11A) deployed across an aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 10A-11B, stent-graft system 1100 includes proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, sealing component 240, anchor 245, and inflatable filling structures 1002 and 1004. Proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, sealing component 240, and anchor 245 are components of stent graft system 1100 that are similar to, and offer similar improvements over, the corresponding components of stent graft system 200. Additionally, expandable filling structures 1002 and 1004 are components of stent graft system 1100 that are similar to, and offer similar improvements over, the corresponding components of stent graft system 1000. Stent graft system 1100 differs from stent graft system 1000 in that its proximal graft 212 does not include wound stent ring 902, and its limb stent grafts 214a and 214b do not include wound stent components 1012 and 1014. As mentioned above, the unsupported section 704 of the proximal graft 212 comprises a graft material (eg, PTFE) without a stent for structural support.

[0092] As described above, the expandable filling structures 1002 and 1004 are fixed, bonded, attached, or otherwise coupled to and surround at least a portion of the outer surface of the limb stent grafts 214a and 214b. In examples where the expandable filling structures 1002 and 1004 are not fixed, bonded, attached, or otherwise coupled to and do not surround the portion of each of the limb stent grafts 214a and 214b inserted within the docking zone 250, the expandable filling structures 1002 and 1004 are shaped to extend into the sac of the aneurysm 14 and surround the portion within the sac when deployed within the proximal graft 212. In other arrangements, the expandable filling structures 1002 and 1004 are fixed, bonded, attached, or otherwise coupled to and surround the portion of each of the limb stent grafts 214a and 214b inserted within the docking zone 250. In such an arrangement, when inflated by a dedicated or shared filling line, each of the expandable filling structures 1002 and 1004 can expand within the lumen of the proximal graft 212 to seal the gutter 302 .

[0093] Figure 12 is a cross-sectional view of an exemplary stent-graft system 1200 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 12, stent-graft system 1200 includes proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, sealing component 240, anchors 245, and inflatable filling structures 1202, 1204, and 1230. Proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, sealing component 240, and anchors 245 are components of stent-graft system 1200 that are similar to the corresponding components of stent-graft system 200 and offer similar improvements over these components.

[0094] In some examples, the shape and flexibility (elasticity) of the expandable filling structure 1230 allows the expandable filling structure 1230 to form a funnel shape when inflated within the sac of the aneurysm 14. For example, the expandable filling structure 1230 is similar to the expandable filling structure 230, except that upon filling, the portion of the expandable filling structure 1230 abutting and adjacent the surface / wall of the sac of the aneurysm 14 extends distally farther (e.g., along the sac surface / sac of the aneurysm 14) than the portion of the expandable filling structure 1230 abutting and adjacent the proximal graft 212, thereby expanding radially toward the surface / wall of the sac of the aneurysm 14 and distally toward the iliac arteries 12 and 13 to create a funnel shape. The expandable filling structure 1230 is fabricated from a material that is sufficiently soft and highly elastic to allow it to form a funnel shape.

[0095] The funnel shape facilitates intubation. In one example, the proximal graft 212 can be deployed into the aorta 10 in the manner described. The expandable filling structure 1230 can be inflated to form a funnel shape. The limb stent grafts 214a and 214b can be inserted into the lumen of the proximal graft 212 guided by the funnel shape of the expandable filling structure 1230. That is, as the limb stent grafts 214a and 214b move proximally toward the proximal neck region 17, the angled surface of the expandable filling structure 1230 can guide the proximal ends of the limb stent grafts 214a and 214b into the lumen of the proximal graft 212. In another example, the limb stent grafts 214a and 214b can be deployed into the aorta 10 in the manner described. The expandable filling structure 1230 can be inflated to form a funnel shape while the proximal graft 212 is being inserted into the aorta 10. As the proximal graft 212 moves distally, the angled surfaces of the expandable filling structure 1230 can guide the proximal graft 212 so that the limb stent grafts 214a and 214b can be inserted into the lumen of the proximal graft 212. In some examples, the stent graft delivery system uses an integral retrograde wire instead of retrograde cannulation into the large bore of the proximal graft 212.

[0096] In some examples, the sealing component 240 can be made from a material (e.g., polyester, PTFE, polyurethane, etc.) that is less flexible than the raw materials (e.g., PTFE, low durometer polyurethane, etc.) that make up the expandable filling structure 1230. A less flexible sealing component 240 (approximately 1 cm wide) can provide a tighter seal within the proximal neck region 17.

[0097] When deployed, the expandable filling structure 1202 is anchored, bonded, attached, or otherwise coupled to the entire outer surface of the limb stent graft 214a (including the iliac arteries 12 and the portion of the limb stent graft 214a that is disposed in the docking zone 250). When deployed, the expandable filling structure 1204 is anchored, bonded, attached, or otherwise coupled to the entire outer surface of the limb stent graft 214b (including the iliac arteries 13 and the portion of the limb stent graft 214b that is disposed in the docking zone 250). Each of the expandable filling structures 1202 and 1204 can be inflated using a dedicated filling line or using a filling line shared with another component of the stent graft system 1200. Upon inflation, the expandable filling structures 1202 and 1204 expand radially from the limb stent grafts 214a and 214b toward the face / wall of the sac of the aneurysm 14. Thus, in response to this expansion, the entire volume of the sac is filled by the combination of the expandable filling structures 1202, 1204, and 1230. In the expanded state, the expandable filling structures 1202 and 1204 surround the limb stent grafts 214a and 214b, respectively. The expandable filling structures 1202 and 1204 can expand within the lumen of the proximal graft 212 to seal any side channels therein. In addition, the expandable filling structures 1202 and 1204 can expand within the iliac arteries 12 and 13 to form a seal within the iliac arteries 12 and 13 when the limb stent grafts 214a and 214b are deployed.

[0098] Figure 13A is a cross-sectional view of an exemplary stent-graft system 1300 deployed across an aneurysm 14 (Figure 1) in various configurations. Figure 13B is another cross-sectional view of an exemplary stent-graft system 1300 (Figure 13A) deployed across an aneurysm 14 (Figure 1) in various configurations. Referring to Figures 1, 2, 13A, and 13B, stent-graft system 1300 includes a proximal graft 212, a first limb stent graft 214a, a second limb stent graft 214b, a sealing component 240, an anchor 245, and at least one support component (e.g., support components 1302 and 1304). Proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, sealing component 240, and anchor 245 are components of stent graft system 1300 that are similar to, and offer similar improvements over, the corresponding components of stent graft system 200. Additionally, once deployed within aorta 10, first limb stent graft 214a and second limb stent graft 214b can dock within proximal graft 212 (e.g., within docking zone 250) in a manner to be described.

[0099] At least one support component (e.g., support components 1302 and 1304) is embedded within the proximal graft 212 to seal any side channels that may form within the lumen of the proximal graft 212 when the limb stent grafts 214a and 214b are inserted therein. In some arrangements, the support components 1302 and 1304 are support inflatable filling structures such as, but not limited to, support rings or support balloons made from polymers (e.g., PTFE, polyurethane, etc.). The support components 1302 and 1304 are embedded within the portion of the proximal graft 212 within the docking zone 250. The support components 1302 and 1304 are attached, secured, bonded (e.g., thermally bonded), sutured, or otherwise coupled to the proximal graft 212 such that their respective inner portions (including inner surface portions) are inside the lumen of the proximal graft 212, while their respective outer portions (including outer surface portions) are outside the proximal graft 212. In some examples, the portion of the proximal graft 212 within the docking zone 250 is unsupported.

[0100] After the proximal graft 212 has been deployed in the aorta 10 in the manner described, each of the support components 1302 and 1304 can be inflated using a dedicated filling line or using a shared filling line shared with another component of the stent-graft system 1300. In some examples, each of the support components 1302 and 1304 can be pre-formed using a bileaflet balloon on the catheter used to deploy the proximal graft 212, and the support components 1302 and 1304 are inflated around the bileaflet balloon on the catheter. Thus, in the inflated state, each of the support components 1302 and 1304 forms an opening 1306 (appropriate to the shape of the bileaflet balloon on the catheter) through which the limb stent-grafts 214a and 214b can be inserted. The opening 1306 appears to be a bileaflet opening. Given that support components 1302 and 1304 are resilient and that opening 1306 is only slightly smaller than the sum of the cross-sectional areas of the proximal ends of limb stent grafts 214a and 214b, support components 1302 and 1304 form a tight seal around limb stent grafts 214a and 214b upon insertion. Although two support components 1302 and 1304 are shown, one or three or four or more support components, such as but not limited to support components 1302 and 1304, could be implemented.

[0101] The implementation of support components 1302 and 1304 allows stent-graft system 1300 to seal the gutter without the need for an inflatable filling structure such as an internal bag. In the absence of a Type II endoleak, a physician may select stent-graft system 1300 with the understanding that it is preferable not to fill the entire sac of aneurysm 14 with a polymer (e.g., an internal bag).

[0102] Figure 14 is a cross-sectional view of an exemplary stent-graft system 1400 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 14, the stent-graft system 1400 includes a proximal graft 212, a first limb stent-graft 214a, a second limb stent-graft 214b, sealing components 1402 and 1440, an anchor 245, and at least one internal support component (e.g., internal support component 1404). The proximal graft 212, the first limb stent-graft 214a, the second limb stent-graft 214b, and the anchor 245 are components of the stent-graft system 1400 that are similar to the corresponding components of the stent-graft system 200 and offer similar improvements over these components. In some examples, anchors 245 of stent-graft system 1400 may be secured or attached to the proximal end of proximal graft 212 or to sealing component 1440. Seal component 1440 is similar to seal component 240, except that it may be narrower in some configurations than seal component 240. Additionally, once deployed within aorta 10, first limb stent graft 214a and second limb stent graft 214b may dock within proximal graft 212 (e.g., within docking zone 250) in the described manner. As shown, a portion of docking zone 250 is within proximal neck region 17, while the remainder of docking zone 250 is within the sac of aneurysm 14. Proximal graft 212 is shown having a wound stent (having multiple wound rings) in addition to the graft material (e.g., proximal graft 212 of FIG. 14 is a stent-graft).

[0103] In some examples, the seal component 1402 is coupled to the distal end of the proximal graft 212 to seal a groove formed when the limb stent grafts 214a and 214b are inserted into the lumen of the proximal graft 212 within the docking zone 250. The seal component 1402 can be an expandable filling structure made from a polymer (e.g., PTFE, polyurethane, etc.) that can be expanded using a dedicated filling line or a shared filling line shared with another component of the stent graft system 1400. In the expanded state, the seal component 1402 can have a single bilobe opening or two openings for receiving the proximal ends of the limb stent grafts 214a and 214b. Given the elasticity of the material of the seal component 1402, the seal component 1402 forms a seal around the limb stent grafts 214a and 214b at the luminal opening of the proximal graft 212.

[0104] An internal support component 1404 is embedded within the proximal graft 212 to provide an additional sealing feature for sealing off any side channels that may form within the lumen of the proximal graft 212 when the limb stent grafts 214a and 214b are inserted therein. In some arrangements, the internal support component 1404 is a supportive, inflatable filling structure, such as, but not limited to, an internal bag made from a polymer (e.g., PTFE, polyurethane, etc.). The internal support component 1404 is embedded within a portion of the proximal graft 212 within the docking zone 250. The internal support component 1404 is attached, secured, bonded (e.g., thermally bonded), sutured, or otherwise connected to the inner surface of the proximal graft 212. The inner surface of the proximal graft 212 faces outward from the lumen of the proximal graft 212. The internal support component 1404 expands within the lumen of the proximal graft 212 upon filling.

[0105] After the proximal graft 212 has been deployed in the aorta 10 in the manner described, the limb stent grafts 214a and 214b are inserted into the lumen of the proximal graft 212. The internal support component 1404 can be inflated after the limb stent grafts 214a and 214b have been inserted using a dedicated filling line or using a shared filling line shared with another component of the stent graft system 1400. In the inflated state, as shown, the internal support component 1404 forms a seal around the proximal ends of the limb stent grafts 214a and 214b, including the space between the limb stent grafts 214a and 214b and the space between the inner surface of the proximal graft 212 and each of the limb stent grafts 214a and 214b. Given that the internal support component 1404 is resilient (e.g., more flexible than polymeric support rings such as support components 1302 and 1304) and expands inwardly within the lumen of the proximal graft 212, the internal support component 1404 can form a tight seal around the limb stent grafts 214a and 214b upon insertion. Although one internal support component 1404 is shown, two or more internal support components, such as, but not limited to, internal support component 1404, can be implemented.

[0106] Figure 15A is a cross-sectional view of an exemplary stent-graft system 1500 deployed across an aneurysm 14 (Figure 1) in various configurations. Figure 15B is another cross-sectional view of an exemplary stent-graft system 1500 (Figure 15A) deployed across an aneurysm 14 (Figure 1) in various configurations. Figure 15C is yet another cross-sectional view of an exemplary stent-graft system 1500 (Figure 15A) deployed across an aneurysm 14 (Figure 1) in various configurations. Referring to Figures 1, 2, 4A-4B, and 15A-15C, stent-graft system 1500 includes proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, expandable filling structures 430, 432, and 434, anchor 245, and inner expandable filling structure 1502. Proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, and anchor 245 are components of stent graft system 1500 that are similar to, and offer similar improvements over, the corresponding components of stent graft system 200. When deployed within aorta 10, first limb stent graft 214a and second limb stent graft 214b can dock within proximal graft 212 (e.g., within docking zone 250) in a manner to be described.

[0107] Additionally, expandable filling structures 430, 432, and 434 are components of stent-graft system 1500 that are similar to, and offer similar improvements over, the corresponding components of stent-graft system 400, except that expandable filling structure 430 (in its expanded state) does not fill or seal the groove inside the lumen of proximal graft 212. Instead, inner expandable filling structure 1502 can be inflated to seal the groove.

[0108] For example, an internal expandable filling structure 1502 is embedded within the proximal graft 212 to seal any side channels that may form within the lumen of the proximal graft 212 when the limb stent grafts 214a and 214b are inserted within the lumen of the proximal graft 212. In some arrangements, the internal expandable filling structure 1502 is a supportive expandable filling structure such as, but not limited to, an internal bag made from a polymer (e.g., PTFE, polyurethane, etc.). The internal support component 1502 is attached, secured, bonded (e.g., thermally bonded), sutured, or otherwise connected to the entire inner surface of the proximal graft 212. The inner surface of the proximal graft 212 faces outward from the lumen of the proximal graft 212. The internal expandable filling structure 1502 expands within the lumen of the proximal graft 212 upon filling.

[0109] In some examples, in an inflated state, the internal expandable filling structure 1502 includes a proximal portion (a cross-section of which is shown in FIG. 15B ) corresponding to the proximal end of the proximal graft 212 and a distal portion (a cross-section of which is shown in FIG. 15C ) corresponding to the distal end of the proximal graft 212. The distal portion of the internal expandable filling structure 1502 corresponds to the docking zone 250. Upon filling, the proximal portion of the internal expandable filling structure 1502 forms a large lumen, whereas the distal portion of the internal expandable filling structure 1502 forms a bilobe lumen. The internal expandable filling structure 1502 can be pre-shaped by the catheter used to deploy the proximal graft 212. For example, after the proximal graft 212 is deployed in the aorta 10 in the described manner, the proximal portion of the internal expandable filling structure 1502 is inflated around a balloon of a catheter having a circular or oval cross-section, whereas the distal portion of the internal expandable filling structure 1502 is inflated around a bilobe balloon of the catheter. The inner expandable filling structure 1502 thus forms a branch lumen within the lumen of the proximal graft 212. The inner expandable filling structure 1502 can be inflated using a dedicated filling line before the limb stent grafts 214a and 214b are inserted or using a shared filling line shared with another component of the stent graft system 1500.

[0110] In the expanded state, the distal portion of the inner expandable filling structure 1502 forms a seal around the proximal ends of the limb stent grafts 214a and 214b, including the space between the limb stent grafts 214a and 214b and the space between the inner surface of the proximal graft 212 and each of the limb stent grafts 214a and 214b. Given that the inner expandable filling structure 1502 is elastic and the inner support component 1404 is expanded inwardly within the lumen of the proximal graft 212, the inner expandable filling structure 1502 is able to form a tight seal around the limb stent grafts 214a and 214b upon insertion.

[0111] Figure 16 is a cross-sectional view of an exemplary stent-graft system 1600 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 16, the stent-graft system 1600 includes a proximal graft 212, a first limb stent-graft 214a, a second limb stent-graft 214b, a sealing component 240, an expandable filling structure 1630, and an anchor 1645. The proximal graft 212, the first limb stent-graft 214a, the second limb stent-graft 214b, and the sealing component 240 are components of the stent-graft system 1600 that are similar to the corresponding components of the stent-graft system 200 and offer similar improvements to these components. The anchor 1645 is similar to the anchor 245, except that the anchor 1645 includes a wound stent having multiple wound rings. The anchors 1645 include hooks or barbs on the wound stent that anchor, secure, or attach to the wall / surface of the aorta 10 proximal to the renal ostium and proximal neck region 17. Once deployed within the aorta 10, the first limb stent graft 214a and second limb stent graft 214b can dock within the proximal graft 212 (e.g., within docking zone 250) in the manner described. The limb stent grafts 214a and 214b are shown to include wound stents having multiple winding rings in some instances.

[0112] The expandable filling structure 1630 is fixed, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212. In some examples, the expandable filling structure 1630 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of the proximal graft 212 except for a portion of the outer surface of the proximal graft 212 adjacent the edge of the proximal end of the proximal graft 212. In other examples, the expandable filling structure 1630 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of the proximal graft 212.

[0113] The expandable filling structure 1630 is a bifurcated expandable filling structure or internal bag such that in the expanded state, the expandable filling structure 1630 surrounds the outer surface of the proximal graft 212 (deployed within the aorta 10) while simultaneously providing two lumens for receiving the limb stent grafts 214 a and 214 b. The expandable filling structure 1630 may be preformed by the catheter used to deploy the proximal graft 212. For example, after the proximal graft 212 is deployed within the aorta 10 in the manner described, the expandable filling structure 1630 is inflated around the bifurcated balloon of the catheter to form lumens for receiving the limb stent grafts 214 a and 214 b, while expanding radially toward the face / wall of the sac of the aneurysm 14 to fill the entire sac except for the lumen of the proximal graft 212 and the bifurcated balloon. The expandable filling structure 1630 can be inflated before the limb stent grafts 214a and 214b are inserted using a dedicated filling line or using a shared filling line shared with another component of the stent graft system 1600. The limb stent grafts 214a and 214b can then be inserted into the lumen of the expandable filling structure 1630 and the lumen of the proximal graft 212. The lumen of the expandable filling structure 1630 leads to and communicates with the lumen of the proximal graft 212. The expandable filling structure 1630 can surround the limb stent grafts 214a and 214b and provide a tight seal to seal the gutter, including the area around the docking zone 250. Thus, only a single filling step is required with the stent graft system 1600, given that the expandable filling structure 1630 can seal the gutter and fill the entire sac at the same time. The limb stent grafts 214a and 214b also do not require an additional inflatable filling structure coupled thereto, thereby reducing complexity and cost.

[0114] Figure 17 is a cross-sectional view of an exemplary stent-graft system 1700 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 17, the stent-graft system 1700 includes a proximal graft 212, a first limb stent-graft 214a, a second limb stent-graft 214b, a sealing component 1740, an anchor 245, and expandable filling structures 1702, 1704, and 1730. The proximal graft 212, the first limb stent-graft 214a, the second limb stent-graft 214b, and the anchors are components of the stent-graft system 1700 that are similar to, and offer similar improvements over, the corresponding components of the stent-graft system 200. As shown, each of the stent-grafts 214a and 214b includes a stent having multiple rings. In some examples, stent grafts 214a and 214b comprise Nellix stents. When deployed within aorta 10, first limb stent graft 214a and second limb stent graft 214b can dock within proximal graft 212 (e.g., within docking zone 250) in a manner to be described.

[0115] As shown, the proximal graft 212 includes a laminated stent component, such as, but not limited to, a Teflon® laminated nickel-titanium (NiTi) stent. The laminated stent component prevents the lumen of the proximal graft 212 from kinking and collapsing during polymer filling of the expandable filling structure 1730, which can be soft within angular anatomical structures. Providing a laminated stent component eliminates the need for a support balloon on the delivery system that delivers the proximal graft 212 into the aorta 10, thereby reducing cost and profile.

[0116] Seal component 1740 is similar to seal component 240, except that in some locations seal component 1740 is narrower than seal component 240. In some examples, seal component 1740 may be made from a material (e.g., polyester, PTFE, polyurethane, etc.) that is less flexible than the raw materials (e.g., PTFE, low durometer polyurethane, etc.) from which expandable filling structure 1730 is made.

[0117] A less flexible, more rigid sealing component 1740 (approximately 1 cm wide) can provide a tighter seal within the proximal neck region 17 and provide a more defined edge than a soft inner bag. A more defined edge at the proximal end of the proximal graft 212 can improve proximal placement accuracy.

[0118] The expandable filling structure 1730 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of the proximal graft 212. In some examples, the expandable filling structure 1730 is secured, bonded, attached, or otherwise coupled to the entire outer surface of the proximal graft 212 except for the portion of the outer surface of the proximal graft 212 coupled to the sealing component 1740. In some examples, in the expanded state, the expandable filling structure 1730 surrounds the outer surface of the proximal graft 212 (deployed within the aorta 10), including the proximal neck region 17 and the portion of the proximal graft 212 within the sac of the aneurysm 14.

[0119] When deployed, the expandable filling structure 1702 is anchored, bonded, attached, or otherwise coupled to the entire outer surface of the limb stent graft 214a (including the iliac arteries 12 and the portion of the limb stent graft 214a that is disposed in the docking zone 250). When deployed, the expandable filling structure 1704 is anchored, bonded, attached, or otherwise coupled to the entire outer surface of the limb stent graft 214b (including the iliac arteries 13 and the portion of the limb stent graft 214b that is disposed in the docking zone 250). Each of the expandable filling structures 1702 and 1704 can be inflated using a dedicated filling line or using a filling line shared with another component of the stent graft system 1700. Upon inflation, the expandable filling structures 1702 and 1704 expand radially from the limb stent grafts 214a and 214b toward the face / wall of the sac of the aneurysm 14. Thus, in response to this expansion, the entire volume of the sac is filled by the combination of the expandable filling structures 1702, 1704, and 1730. The expandable filling structures 1702 and 1704 may also expand within the lumen of the proximal graft 212 to seal any side channels therein. In addition, the expandable filling structures 1702 and 1704 may expand within the iliac arteries 12 and 13 to form a seal within the iliac arteries 12 and 13 when the limb stent grafts 214a and 214b are deployed.

[0120] Figure 18 is a cross-sectional view of an exemplary stent-graft system 1800 deployed across an aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1, 2, and 18, stent-graft system 1800 includes a stacked stent component 1812, a first limb stent-graft 214a, a second limb stent-graft 214b, a sealing component 1840, an anchor 1845, locking features 1852 and 1854, and an expandable filling structure 1830. First limb stent-graft 214a and second limb stent-graft 214b are components of stent-graft system 1800 that are similar to, and offer similar improvements over, the corresponding components of stent-graft system 200. As shown, each of stent-grafts 214a and 214b includes a stent having multiple rings. In some examples, the stent grafts 214a and 214b comprise Nellix stents. When deployed within the aorta 10, the first limb stent graft 214a and the second limb stent graft 214b can dock within the stacked stent component 1812 in the described manner (e.g., within the docking zone 250).

[0121] As shown, the laminated stent component 1812 includes components such as, but not limited to, a Teflon® laminated nickel-titanium (NiTi) stent. The laminated stent component 1812 may be wire wound or laser cut. The laminated stent component 1812 prevents kinking and collapse during polymer filling of the expandable filling structure 1830, whose lumen may be soft within angular anatomical structures. Providing the laminated stent component 1812 eliminates the need for a support balloon on the delivery system that delivers it into the aorta 10, thereby reducing cost and profile. After the expandable filling structure 1830 is filled, the limb stent grafts 214a and 214b (which may be Nellix®) are inserted into the laminated stent component 1812 within the docking zone 250.

[0122] The expandable filling structure 1830 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of the stacked stent component 1812. In some examples, the expandable filling structure 1830 is secured, bonded, attached, or otherwise coupled to the entire outer surface of the proximal graft 212 except for the portion of the outer surface of the stacked stent component 1812 coupled to the sealing component 1840. In some examples, in the expanded state, the expandable filling structure 1830 surrounds the outer surface of the stacked stent component 1812 (deployed within the aorta 10), including the proximal neck region 17 and the portion of the stacked stent component 1812 within the sac of the aneurysm 14. In some arrangements, in the expanded state and when deployed, the expandable filling structure 1830 surrounds or encapsulates the outer surface of the portion of the sealing component 1840 inside the sac of the aneurysm 14. In some instances, the expandable filling structure 1830 extends distally towards the aortic bifurcation 11 and the iliac arteries 12 and 13 to fill the entire sac of the aneurysm 14 .

[0123] In some examples, the anchors 1845 can be hooks or barbs on a stent of the stacked stent component 1812. As shown, the hooks or barbs of the anchors 1845 are positioned on the stent ring closest to the renal arteries 15 and 16. The hooks or barbs of the anchors 1845 can be positioned on other stent rings of the stacked stent component 1812, as well as on more than one stent ring of the stacked stent component 1812.

[0124] The sealing component 1840 can be an expandable sealing ring. In some implementations, the sealing component 1840 is coupled to the stacked stent component 1812. For example, the sealing component 1840 is attached, secured, or otherwise coupled to an outer surface of the proximal end of the stacked stent component 1812. In the expanded state, the sealing component 1840 surrounds the proximal neck region 17 and the portion of the stacked stent component 1812 within the sac of the aneurysm 14 when the stacked stent component 1812 is deployed. In some examples, the sealing component 1840 does not reach or extend beyond the edge of the proximal end of the stacked stent component 1812 when in the expanded state, such that the portion of the stacked stent component 1812 adjacent to the edge of the proximal end of the stacked stent component 1812 (e.g., the portion having the anchors 1845) is not surrounded by the sealing component 1840. Generally, devices having sealing components of predetermined widths can be deployed over a range of neck lengths in the aortic neck region 17; i.e., a sealing component having an expanded width greater than the neck length cannot be deployed within the aortic neck region 17 of a subject having this neck length. In contrast, the stent grafts described herein (e.g., stent graft system 1800) can be deployed within the aorta 10 of a subject having a neck length shorter than that deployable by other devices. This is because the sealing component 1840 is configured to extend into the sac of the aneurysm 14 (with the anchors 1845 remaining fixed to the wall of the aortic neck region 17) when the neck length of the aortic neck region 17 is short and the sealing component 1840 does not otherwise have any space to expand within the aortic neck region 17. The portion of the sealing component 1840 within the sac of the aneurysm 14 can be used in conjunction with an inflatable filling structure 1830 for sac management (e.g., the inflatable filling structure 1830 encapsulates the portion of the sealing component 1840 within the sac).

[0125] Each of the locking features 1852 and 1854 includes a polymeric sealing sac on the proximal end of the respective limb stent grafts 214a and 214b. In some arrangements, the polymeric sealing sac is an inflatable filling structure that is secured, bonded, attached, or otherwise coupled to the outer surface of the respective limb stent grafts 214a and 214b within the docking zone 250 when deployed. The locking features 1852 and 1854 (when inflated) surround the outer surface of the proximal end of the respective limb stent grafts 214a and 214b. In some arrangements, the inflatable filling structures 1852 and 1854 are not secured, bonded, attached, or otherwise coupled to and do not surround the portion of the respective limb stent grafts 214a and 214b that is outside the docking zone 250 when deployed. When the limb stent grafts 214a and 214b are inflated by a dedicated or shared filling line while docked within the docking zone 250, the locking features 1852 and 1854 expand radially from the proximal ends of the limb stent grafts 214a and 214b toward the lumen of the stacked stent component 1812 to seal the side groove between the inner surface of the stacked stent component 1812 and the outer surface of the limb stent grafts 214a and 214b within the docking zone 250.

[0126] Figure 19 is a cross-sectional view of an exemplary stent-graft system 1900 deployed across the aneurysm 14 (Figure 1) in various configurations. With reference to Figures 1-3B and 19, stent-graft system 1900 includes proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, expandable filling structure 330, sealing component 240, anchors 245, support structure 1920, and expandable structures 1932 and 1934. Proximal graft 212, first limb stent graft 214a, second limb stent graft 214b, sealing component 240, and anchors 245 are components of stent-graft system 1900 that are similar to the corresponding components of stent-graft system 200 and offer similar improvements over these components. Expandable filling structure 330 is a component of stent graft system 1900 that is similar to, and offers similar improvements over, the corresponding component of stent graft system 300. When deployed within aorta 10, first limb stent graft 214a and second limb stent graft 214b can dock within proximal graft 212 (e.g., within docking zone 250) in the manner described.

[0127] Stent-graft system 1900 differs from stent-graft system 300 in that proximal graft 212 includes a support structure 1920. Support structure 1920 is embedded within proximal graft 212. In some arrangements, support structure 1920 comprises a helical polymer support ring. Support structure 1920 is attached, secured, bonded (e.g., thermally bonded), sutured, or otherwise coupled to the inner surface of proximal graft 212. Support structure 1920 faces or is internal to the lumen of proximal graft 212. Support component 1920 expands within the lumen of proximal graft 212 when filled via a dedicated filling line or a shared filling line shared with another component of stent-graft system 1900. Support component 1920 prevents the lumen of proximal graft 212 from kinking and collapsing during polymer filling of expandable filling structure 330, which can be soft within angular anatomical structures. The helical shape of the support structure 1920 may improve the joint integrity of the docked limb stent grafts 214a and 214b.

[0128] In some examples, the expandable filling structure 1932 is fixed, bonded, attached, or otherwise coupled to the outer surface of the proximal end of the stent graft 214a. The expandable filling structure 1932 (when expanded) surrounds the outer surface of the proximal end of the limb stent graft 214a. In some arrangements, the expandable filling structure 1002 is not fixed, bonded, attached, or otherwise coupled to and does not surround portions of the limb stent graft 214a that are outside the docking zone 250 when deployed. With respect to the limb stent graft 214b, the expandable filling structure 1934 is similar to the expandable filling structure 1932. When filled using a dedicated filling line or using a shared filling line shared with another component of stent-graft system 1900 while the proximal ends of limb stent grafts 214a and 214b are docked within the lumen of proximal graft 212 at docking zone 250, the expandable filling structures 1932 and 1934 expand from within the lumen of proximal graft 212 within docking zone 250 to seal the gutter. The expandable filling structures 1932 and 1934 expand radially from the proximal ends of limb stent grafts 214a and 214b toward the inner surface of proximal graft 212. As described above, the expandable filling structure 330 is capable of filling the sac of the aneurysm 14 in its expanded state.

[0129] 20A, 20B, 20C, 20D, 20E, 20F, 20G, 20H, 20I, 20J, 20K, and 20L show examples of proximal grafts 2000 in various configurations. Referring to FIGS. 1, 20A, 20B, 20C, 20D, 20E, 20F, 20G, 20H, 20I, 20J, 20K, and 20L, the proximal graft 2000 is a graft component made of graft material. The proximal graft 2000 has a proximal end, a distal end, an inner surface, and an outer surface. The proximal end of the proximal graft 2000 is the end of the proximal graft 2000 that is closer to or within the proximal neck region 17 when deployed. The distal end of the proximal graft 2000 is the end of the proximal graft 2000 that is closer to the aortic bifurcation 11 when deployed. The distal end of the proximal graft 2000 can be positioned within the sac of the aneurysm 14. The proximal graft 2000 has a cylindrical shape and forms a bore or tubular lumen 2020. The inner surface of the proximal graft 2000 faces the tubular lumen 2020. The outer surface of the proximal graft 2000 faces the wall / surface of the aorta 10 when deployed and faces outward from the lumen 2020 of the proximal graft 2000. Blood is configured to flow through the lumen 2020.

[0130] The proximal graft 2000 includes at least one support component. Each support component may be embedded within the proximal graft 2000. In some arrangements, the support component is a support, inflatable filling structure, such as, but not limited to, a support ring or support balloon made from a polymer (e.g., PTFE, polyurethane, etc.), that surrounds the proximal graft 2000. In some arrangements, the support components are attached, secured, bonded (e.g., thermally bonded), sutured, or otherwise coupled to the proximal graft 2000 such that an inner portion of each support component (including an inner surface portion) is inside the lumen 2020, while the remaining outer portion of the support component (including an outer surface portion) is outside the proximal graft 2000 and coupled to the outer surface of the proximal graft 2000. In other arrangements, the support components are attached, secured, bonded (e.g., thermally bonded), sewn, or otherwise coupled to the outer surface of the proximal graft 2000. The support components may be inflated using an appropriate fill line.

[0131] 20A, proximal graft 2000 includes two support components 2001 and 2002. Support component 2001 is positioned at the proximal end of proximal graft 2000, while support component 2002 is positioned at the distal end of proximal graft 2000.

[0132] 20B, proximal graft 2000 further includes anchor 2030. Anchor 2030 may be a fixation feature, a fixation stent frame, etc. Anchor 2030 anchors, secures, or attaches the proximal end of proximal graft 2000 to the wall / surface of aorta 10 in the manner described with respect to anchor 245.

[0133] 20C, the proximal graft 2000 further includes an expandable structure 2032. In an expanded state, the expandable structure 2032 expands radially toward the surface / wall of the aorta 10 to fill one or more of the sac of the aneurysm 14 (toward sac management), the space between the outer surface of the proximal graft 2000 and the surface / wall of the proximal neck region 17 (toward a neck seal), and the space between the limb stent grafts (e.g., limb stent grafts 2012 and 2014) and the surface / wall of the iliac arteries 12 and 13 in a manner described herein. The expandable structure 2032 can be attached, secured, bonded (e.g., thermally bonded), sutured, or otherwise coupled to at least a portion of the outer surface of the proximal graft 2000.

[0134] 20D and 20E, proximal graft 2000 includes support components 2001 and 2002, anchor 2030, expandable structure 2032, and a bifurcation feature including lumens 2034 and 2035. That is, proximal graft 2000 is shaped such that lumen 2020 located at its proximal end bifurcates into lumens 2034 and 2035 at a docking zone at the distal end of proximal graft 2000. The proximal and distal ends are opposite ends of proximal graft 2000. Limb stent grafts 2012 and 2014 can be docked or inserted into lumens 2034 and 2035 in the manner described herein. Limb stent grafts 2012 and 2014 include respective expandable structures 2016 and 2018 for pouch management and sealing in the manner described herein.

[0135] 20F and 20G, proximal graft 2000 includes support components 2001-2003 and anchor 2030. Support component 2003 is located between support components 2001 and 2002 along proximal graft 2000. Support components 2001-2003 are spaced apart along proximal graft 2000. In some arrangements, proximal graft 2000 includes inner sleeves or rings 2044 and 2045 that form lumens 2046 and 2047, respectively, for receiving limb stent grafts 2012 and 2014. Inner sleeves or rings 2044 and 2045 are within lumen 2020 at the docking zone between support components 2002 and 2003. In some examples, inner sleeves or rings 2044 and 2045 can be sleeves or support rings fabricated from a polymer (e.g., PTFE, polyurethane, etc.). The inner sleeves or rings 2044 and 2045 and the bifurcation features can eliminate leakage from the gutters.

[0136] In Figures 20H and 20I, proximal graft 2000 includes support components 2001-2003 and anchor 2030, and does not have any bifurcation features or inner sleeves. In Figure 20J, proximal graft 2000 includes support components 2001-2004 and anchor 2030. Support components 2003 and 2004 are located between support components 2001 and 2002 along proximal graft 2000. Support components 2001-2004 are spaced apart from one another along proximal graft 2000.

[0137] In Figure 20K, proximal graft 2000 includes support components 2001-2005. Support components 2003-2005 are located between support components 2001 and 2002 along proximal graft 2000. Support components 2001-2005 are spaced apart from one another along proximal graft 2000. In Figure 20L, proximal graft 2000 includes support components 2001-2005 and anchor 2030.

[0138] 21A, 21B, 21C, and 21D show examples of the proximal extension stent graft 2100 in various configurations. Referring to FIGS. 1, 21A, 21B, 21C, and 21D, the proximal extension stent graft 2100 is a proximal stent graft. The proximal extension stent graft 2100 has a proximal end, a distal end, an inner surface, and an outer surface. The proximal end of the proximal extension stent graft 2100 is the end of the proximal extension stent graft 2100 closer to or within the proximal neck region 17 when deployed. The distal end of the proximal extension stent graft 2100 is the end of the proximal extension stent graft 2100 closer to the aortic bifurcation 11 when deployed. Generally, the distal end of the proximal extension stent graft 2100 can be positioned within the sac of the aneurysm 14. The proximal extension stent graft 2100 has a cylindrical shape and forms a bore or tubular lumen 2120. The inner surface of the proximal extension stent graft 2100 faces the lumen 2120. The outer surface of the proximal extension stent graft 2100 faces the wall / surface of the aorta 10 when deployed and faces outward from the lumen 2120. Blood is configured to flow through the lumen 2120. The proximal extension stent graft 2100 includes a wound stent 2101 having a plurality of wound rings.

[0139] Figure 21B shows a proximal extension stent graft 2100 further including an anchor 2130 similar to anchor 2030. Figure 21C shows a proximal extension stent graft 2100 further including an expandable structure 2132 similar to expandable structure 2032.

[0140] 21C and 21D includes encapsulated wound stents 2134 and 2135 within a docking zone on its distal end. The encapsulated wound stents 2134 and 2135 form lumens 2144 and 2145 within lumen 2120. The encapsulated wound stents 2134 and 2135 allow a limb stent graft to dock within lumen 2120 of proximal extension stent graft 2100. To ensure that the limb stent graft and the encapsulated wound stents 2134 and 2135 remain coapted, the distal end of the limb stent graft is oversized (e.g., has a diameter greater than the diameter of lumens 2144 and 2145) so that the limb stent graft generates an outward radial force against the encapsulated wound stents 2134 and 2135.

[0141] In some arrangements, the grafts 2000 and 2100 are straight, rigid bores. In some arrangements, the grafts 2000 and 2100 are fabricated from a more flexible PTFE material. In arrangements where the grafts 2000 and 2100 are fabricated from a flexible PTFE material, the blood pressure inside the lumens 2020 and 2120 presses the walls of the grafts 2000 and 2100 against the vessel wall of the aorta 10, allowing the grafts 2000 and 2100 to function like an active seal. That is, an active seal is formed between the outer surface of the grafts 2000 and 2100 and the vessel wall of the aorta 10.

[0142] Figure 22A shows an exemplary proximal extension inflatable filling structure 2212 of system 2200 in various configurations. Figure 22B is a cross-sectional view of system 2200 (Figure 22A) deployed across aneurysm 14 (Figure 1) in various configurations. Referring to Figures 1, 22A, and 22B, system 2200 includes proximal extension inflatable filling structure 2212, first limb stent graft 2213, second limb stent graft 2214, anchor 2245, inflatable filling structure 2216, and inflatable filling structure 2218.

[0143] In some examples, the proximal extension expandable filling structure 2212 is an expandable filling structure (e.g., an internal bag). In various examples, the proximal extension expandable filling structure 2212 has a wider polymer-filled seal zone compared to the sealing rings on other devices. The width of the proximal extension expandable filling structure 2212 is denoted as Y, as shown. In some examples, Y is approximately 20 mm. As discussed herein, a wider proximal extension expandable filling structure 2212 can tolerate placement accuracy even when the proximal extension stent graft 2000 is placed lower than optimal (e.g., 1 mm lower) and still provide a tight seal within the proximal neck region 17. Similarly, a wider proximal extension expandable filling structure 2212 has a wider treatment diameter range, i.e., fewer size numbers (and fewer SKU numbers) are required to treat the entire vascular treatment range. In some configurations, the neck length of the proximal extension expandable filling structure 2212 is shorter than the neck lengths of other devices. Additionally, the wider proximally extending expandable filling structure 2212 can improve neck angle accommodation.

[0144] In some arrangements, the proximal extension, expandable filling structure 2212 has or is in communication with a fill line 2206 that communicates a curable expansion material or filled polymer (e.g., polyester, PTFE, polyurethane, etc.) in liquid form. The proximal extension, expandable filling structure 2212 is deployed within the proximal neck region 17 and can be inflated within the proximal neck region 17 using the fill line 2206. In an inflated state, the proximal extension, expandable filling structure 2212 forms a seal within the proximal neck region 17 to eliminate Type II endoleaks. The proximal extension, expandable filling structure 2212 can be filled to a higher pressure than other devices. Similarly, the proximal extension, expandable filling structure 2212 can provide a more precise seal zone and a more circumferential seal within the proximal neck region 17. The proximal extension inflatable filling structure 2212 can prevent the inflatable filling structures 2216 and 2218 from prolapsing into the renal arteries 15 and 16 when the inflatable filling structures 2216 and 2218 are inflated or when the limb stent grafts 2213 and 2214 are docked in the docking zone 2250. The lumens 2202 and 2204 are also positioned within the proximal neck region 17 when the proximal extension inflatable filling structure 2212 forms a seal within the proximal neck region 17.

[0145] As shown, the proximal extension expandable filling structure 2212 forms lumens 2202 and 2204 to which the limb stent grafts 2213 and 2214 are docked. Lumens 2202 and 2204 correspond to docking zone 2250. When the proximal extension expandable filling structure 2212 is in an expanded state, lumens 2202 and 2204 are fully expanded. The size of the fully expanded lumens 2202 and 2204 is slightly smaller than the size of the proximal ends of the limb stent grafts 2213 and 2214. Given the elasticity of the material of the proximal extension expandable filling structure 2212 (in its expanded state), the material of the proximal extension expandable filling structure 2212 around lumens 2202 and 2204 forms a seal when the limb stent grafts 2213 and 2214 are docked within the lumens 2202 and 2204.

[0146] In various arrangements, the anchor 2245 (anchor feature, anchor stent frame, etc.) anchors, secures, or attaches the proximal end of the proximally extended expandable filling structure 2212 to the wall / surface of the aorta 10 to prevent blood from entering the area between the outer and inner walls of the aneurysm 14 and improves the transition from the aorta 10 into the lumen of the proximally extended expandable filling structure 2212. In some examples, the anchor 2245 is sewn or sutured onto the proximally extended expandable filling structure 2212. In some examples, the anchor 2245 can comprise a stent, graft, and / or other expandable luminal support structure. In some examples, the anchor 2245 is self-expanding and comprises a suprarenal laser-cut stent with attached coils. In some examples, the anchor 2245 has a shorter stent than that of some existing stent-graft systems to eliminate free crown. The length of the anchor 2245 is shown as X. In some examples, X is about 30 mm or less. A shorter stent allows for greater neck angle accommodation due to improved stent graft flexibility. Thus, anchors 2245 are shorter, have fewer crowns and fewer anchors, and allow system 2200 to be used for smaller procedure sizes. That is, stent graft system 2200 is a low profile delivery system that can be used for smaller procedure sizes.

[0147] The expandable filling structure 2216 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of the limb stent graft 2213. The expandable filling structure 2218 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of the limb stent graft 2214. Each of the expandable filling structures 2216 and 2218 can be inflated using a dedicated filling line or using a filling line shared with another component of the system 2200. Upon inflation, the expandable filling structures 2216 and 2218 expand radially from the limb stent grafts 2213 and 2214 toward the face / wall of the sac of the aneurysm 14. In the expanded state, the expandable filling structures 2216 and 2218 surround the limb stent grafts 2213 and 2214, respectively.

[0148] FIG. 23 illustrates an exemplary proximal extension expandable structure of a stent-graft system in various configurations. Referring to FIGS. 1 and 23 , an anchor 2245 (such as a fixation feature and a fixation stent frame) anchors, secures, or attaches the proximal end of the proximal extension expandable filling structure 2312 to the wall / surface of the aorta 10. The proximal extension expandable filling structure 2312 can be an element such as, but not limited to, the proximal extension expandable filling structure 2212. In some examples, the anchor 2345 is sewn or sutured onto the proximal extension expandable filling structure 2312. In some examples, the anchor 2345 can include a stent, a graft, and / or other expandable luminal support structure. In some examples, the anchor 2345 is connected to or extends from the stent 2320 of the proximal extension expandable filling structure 2312. As shown, the anchor 2345 includes hooks or barbs for fixation. In some examples, anchor 2345 is self-expanding and comprises a suprarenal laser cut stent with attached coils. Proximally extending expandable filling structure 2312, upon expansion, can form two lumens 2302 and 2304 similar to lumens 2202 and 2204.

[0149] Thus, in some configurations, the stent-graft systems described herein include wider sealing rings that improve placement accuracy while providing a wider treatment diameter range. In some configurations, an inflatable filling structure (e.g., an internal bag) can be provided to prevent Type II endoleaks. In some configurations, a proximal graft with a larger bore diameter is easier to intubate than the much smaller retrograde lumen in some other devices. A proximal graft with a larger bore diameter can also reduce or eliminate the possibility of intubating the wrong (ipsilateral) lumen.

[0150] The present technology is not intended to be limited with respect to the specific configurations described in this application, which are intended to be illustrative of aspects of the present technology. As will be apparent to those skilled in the art, many modifications and variations of the present technology can be made without departing from its spirit and scope. In addition to those enumerated herein, functionally equivalent systems and methods within the scope of the present technology will be apparent to those skilled in the art from the foregoing description. Such modifications and variations are intended to fall within the scope of the present technology. It is understood that the present technology is not limited to specific systems and methods of using such systems, which may, of course, vary. It is also understood that the terminology used herein is for the purpose of describing particular configurations only, and is not intended to be limiting. [Explanation of symbols]

[0151] 10 aorta 200 Stent Graft System 214a First limb stent graft 230 Expandable filling structure 240 Seal Components 245 Anchor

Claims

1. 1. A stent graft system comprising: a first graft; and a second graft; and a third graft; and Including, each of the first graft, the second graft, and the third graft forms a single lumen; When deployed, the first graft, the second graft, and the third graft are coupled to one another within the aorta. A stent graft system characterized by:

2. The stent graft system of claim 1, wherein the second graft and the third graft are inserted into the single lumen of the first graft when deployed.

3. a portion of the first graft disposed in a proximal neck region of the aorta when deployed; a portion of the second graft disposed in a first iliac artery of the aorta when deployed; a portion of the third graft disposed in the second iliac artery of the aorta when deployed; The stent graft system according to claim 1 .

4. 10. The stent graft system of claim 1, wherein the first graft, the second graft, and the third graft are separate grafts prior to deployment.

5. an expandable filling structure at least partially surrounding the first graft and configured to expand within the aorta when deployed; a sealing component coupled to the first graft to form a seal at the proximal neck region of the aorta; The stent graft system of claim 1 further comprising:

6. The stent graft system of claim 5, wherein the sealing component is filled to a pressure greater than the pressure of the expandable filling structure.

7. The stent graft system of claim 5, wherein the sealing component and the expandable filling structure are filled using different channels.

8. The stent graft system of claim 5, wherein when deployed, the expandable filling structure at least partially surrounds the proximal ends of the second graft and the third graft docked within the single lumen of the first graft.

9. the expandable filling structure is coupled to the first graft; the second graft and the third graft dock within the single lumen of the first graft at a docking zone; the expandable filling structure, in an expanded state, surrounds at least a portion of the second graft and the third graft that is outside the docking zone; 6. The stent graft system according to claim 5.

10. the expandable filling structure is coupled to the first graft; the expandable filling structure, in an expanded state, surrounds the portions of the second graft and the third graft that are inside the iliac arteries when deployed; 6. The stent graft system according to claim 5.

11. the second graft and the third graft dock within the single lumen of the first graft at a docking zone; the first graft includes a supportive, expandable filling structure coupled to a portion of the first graft at the docking zone; the supportive, expandable filling structure expands to provide structural integrity to the first graft; 6. The stent graft system according to claim 5.

12. 12. The stent graft system of claim 11, wherein the supporting expandable filling structure expands before or during expansion of the expandable filling structure.

13. the second graft and the third graft dock within the single lumen of the first graft at a docking zone; the first graft includes a wound stent component coupled to a portion of the first graft at the docking zone and including a plurality of wound rings.

6. The stent graft system according to claim 5.

14. 14. The stent graft system of claim 13, wherein the single lumen of the first graft at the wound stent component is open.

15. the second graft and the third graft dock within the single lumen of the first graft at a docking zone; the first graft includes a wound stent ring coupled to a portion of the first graft at the docking zone and including a single ring of wound stent.

6. The stent graft system according to claim 5.

16. The stent graft system of claim 5, wherein the expandable filling structure is more flexible than the sealing component.

17. The stent graft system of claim 5, wherein the expandable filling structure forms a funnel shape in an expanded state.

18. 18. The stent graft system of claim 17, wherein the expandable filling structure forms the funnel shape by extending a portion of the expandable filling structure adjacent the wall of the aorta farther along the wall of the aorta than another portion of the expandable filling structure abutting and adjacent the first graft.

19. 6. The stent graft system of claim 5, wherein the expandable filling structure is a bifurcated expandable filling structure that forms two lumens for receiving the second graft and the third graft when in an expanded state.

20. a first expandable filling structure at least partially surrounding the first graft; a second expandable filling structure at least partially surrounding the second graft; a third expandable filling structure at least partially surrounding the third graft; Further comprising: the first inflatable filling structure, the second inflatable filling structure, and the third inflatable filling structure are separate inflatable filling structures that expand within the aorta when deployed. The stent graft system according to claim 1 .

21. 21. The stent graft system of claim 20, wherein the first expandable filling structure extends into the single lumen of the first graft.

22. the second expandable filling structure surrounds a portion, but not all, of the outer surface of the second graft; the third expandable filling structure surrounds a portion, but not all, of the exterior surface of the third graft; 21. The stent graft system of claim 20.

23. the second expandable filling structure surrounds the entire exterior surface of the second graft; the third expandable filling structure surrounds the entire exterior surface of the third graft; 21. The stent graft system of claim 20.

24. further comprising an expandable filling structure coupled to the first graft; the expandable filling structure forms a seal at the proximal neck region of the aorta while in an expanded state; the second graft and the third graft dock within the single lumen of the first graft at a docking zone; the expandable filling structure, while in the expanded state, surrounds at least a portion of the second graft and the third graft that is outside the docking zone; the expandable filling structure at least partially surrounds the first graft while in the expanded state; The stent graft system according to claim 1 .

25. a first expandable filling structure at least partially surrounding the second graft; a second expandable filling structure at least partially surrounding the third graft; Further comprising: the first and second inflatable filling structures expand within the aorta when deployed to at least partially surround the first graft; The stent graft system according to claim 1 .

26. 26. The stent graft system of claim 25, wherein the second graft and the third graft each include a wound stent component including a plurality of wound rings.

27. the first and second expandable filling structures are secured to portions of the second and third grafts inserted into the lumen of the first graft; the first expandable filling structure and the second expandable filling structure expand within the lumen of the first graft; 26. The stent graft system of claim 25.

28. 26. The stent graft system of claim 25, wherein the first and second expandable filling structures extend into the lumen of the first graft.

29. the second graft and the third graft dock within the single lumen of the first graft at a docking zone; the first graft includes at least one supportive, expandable filling structure coupled to a portion of the first graft at the docking zone, and the second graft and the third graft are inserted into respective openings of the at least one supportive, expandable filling structure when the second graft and the third graft are inserted into the single lumen of the first graft at the docking zone; the at least one supportive, expandable filling structure provides a seal within the lumen of the first graft for the first graft, the second graft, and the third graft; The stent graft system according to claim 1 .

30. 30. The stent graft system of claim 29, wherein the opening has a bilobed shape.

31. the second graft and the third graft dock within the single lumen of the first graft at a docking zone; the first graft includes at least one internal support component coupled to a portion of the first graft at the docking zone; the internal support component expands within the single lumen of the first graft upon inflation and forms a seal around the second graft and the third graft when the second graft and the third graft are inserted into the single lumen of the first graft at the docking zone. The stent graft system according to claim 1 .

32. 32. The stent graft system of claim 31, wherein the first graft includes a sealing component coupled to a distal end of the first graft.

33. the second graft and the third graft dock within the single lumen of the first graft at a docking zone; the first graft includes an internal expandable filling structure coupled to the first graft at the docking zone; the internal expandable filling structure expands within the single lumen of the first graft upon inflation and forms a seal around the second graft and the third graft when the second graft and the third graft are inserted into the single lumen of the first graft at the docking zone; the inner expandable filling structure forms a branched lumen; The stent graft system according to claim 1 .

34. The branched lumen comprises: Inflating a proximal portion of the inner expandable filling structure around a first balloon having a circular or oval cross section; and inflating a distal portion of the inner expandable filling structure about a second balloon having a bilobal cross-section; It is formed by 34. The stent graft system of claim 33.

35. The stent graft system of claim 1 , wherein the first graft comprises a stacked stent component.

36. 36. The stent graft system of claim 35, wherein the laminated stent component comprises a Teflon laminated nickel-titanium (NiTi) stent.

37. The stent graft system of claim 1 further comprising an anchor configured to attach the first graft to the aorta and including hooks or barbs.

38. 38. The stent graft system of claim 37, wherein the anchors are positioned on stent rings of the first graft.

39. The stent graft system of claim 1 further comprising a support structure coupled to the first graft and residing in the lumen of the first graft.

40. 40. The stent graft system of claim 39, wherein the support structure comprises a helical polymeric support ring.

41. 1. A stent graft system comprising: a graft forming a lumen; at least one support component embedded in the graft; Including, each of the at least one support component is a polymer ring surrounding the graft; at least a portion of each of the at least one support component is coupled to an exterior surface of the graft; the outer surface faces outward from the lumen; A stent graft system characterized by:

42. the at least one support component includes a first support component and a second support component; the first support component is positioned on a first end of the graft; the second support component is positioned on a second end of the graft; 42. The stent graft system of claim 41 .

43. 42. The stent graft system of claim 41, wherein the at least one support component comprises three or more support components spaced apart along the graft.

44. 42. The stent graft system of claim 41, wherein the graft further defines a bifurcation feature including two additional lumens for receiving limb grafts.

45. 42. The stent graft system of claim 41, wherein the graft further comprises an inner sleeve or ring within the lumen that receives a limb graft.

46. a proximally extending expandable filling structure that forms a seal in the proximal neck region of the aorta when the proximally extending expandable filling structure is inflated; at least one lumen formed by the proximally extending expandable filling structure when the proximally extending expandable filling structure is expanded, each of the at least one lumen receiving a limb stent graft, the at least one lumen being positioned in the proximal neck region when the proximally extending expandable filling structure forms the seal in the proximal neck region; A system comprising:

47. 47. The system of claim 46, further comprising an anchor coupled to the proximally extending expandable filling structure.

48. 48. The system of claim 47, wherein the anchor has a length of 30 mm.

49. 47. The system of claim 46, wherein the width of the proximally extending expandable filling structure when filled is 20 mm.

50. 47. The system of claim 46, wherein the proximally extending inflatable filling structure is an internal bag.

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