Stent graft systems and methods with cuff and branches

Abstract

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 the aorta.

Description

[0001] Cross-references to Related Patent Applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 735,771, filed on September 24, 2018, which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present technology generally relates to endoluminal vascular prostheses and methods of placing / deploying the same. More specifically, various arrangements disclosed herein relate to stent-graft systems and methods of placing / deploying the same for treating aortic aneurysms. Background Art

[0004] An aneurysm is an enlargement or bulge in a blood vessel that is often prone to rupture, thus posing a serious risk to the patient. Aneurysms can occur in any blood vessel, but they are of particular concern when they occur in the cerebral vasculature or the aorta.

[0005] 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 AAAs. Suprarenal AAAs arise above the renal arteries. Thoracic aortic aneurysms (TAAs) arise in the ascending, transverse, or descending portions of the superior aorta. Infrarenal aneurysms are the most common, accounting for approximately 70% of all aortic aneurysms. Suprarenal aneurysms are less common, accounting for approximately 20% of aortic aneurysms. TAAs are the least common and often the most difficult to treat.

[0006] The most common aneurysm shape is a "fusiform" shape, in which the enlargement extends around the entire circumference of the aorta. Less commonly, an aneurysm can appear as a bulge on one side of the vessel attached to a narrow neck. TAAs are often dissecting aneurysms caused by a hemorrhagic separation of the aortic wall, usually located within the medial layer. A common treatment for these types and forms of aneurysms is open surgical repair. For patients who are otherwise quite healthy and do not have serious comorbidities, open surgical repair can be very successful. However, this open surgical procedure is not without problems because access to the abdominal and thoracic aortas is difficult to obtain and because the aorta must be clamped, placing significant stress on the patient's heart.

[0007] Endovascular grafts are widely used to treat aortic aneurysms. Typical endovascular grafting procedures utilize stent graft placement to treat aneurysms. The purpose of the graft is to isolate the diseased area of ​​the aortic wall from the aortic blood pressure and prevent further expansion or rupture. Typically, endovascular repair is performed through one or both iliac arteries, with intraluminal access to the aneurysm. The graft is then implanted. Successful endovascular surgery results in a significantly shorter recovery period than open surgery. Summary of the Invention

[0008] Various stent-graft systems and methods described herein relate to treating aneurysms. In some arrangements, 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. During deployment, the first graft, the second graft, and the third graft are coupled together within the aorta.

[0009] In some arrangements, the second graft and the third graft are inserted into a single lumen of the first graft during deployment. In some arrangements, a portion of the first graft is positioned in the proximal neck region of the aorta during deployment. A portion of the second graft is positioned in the first iliac artery of the aorta during deployment. A portion of the third graft is positioned in the second iliac artery of the aorta during deployment.

[0010] In some arrangements, prior to deployment, the first graft, the second graft, and the third graft are separate grafts. In some arrangements, the stent-graft system further includes an expandable filling structure that at least partially surrounds the first graft. The expandable filling structure expands within the aorta during deployment. A sealing member is coupled to the first graft. The sealing member forms a seal in the proximal neck region of the aorta.

[0011] In some arrangements, the sealing component is filled to a pressure higher than the pressure of the expandable filling structure. In some examples, different channels are used to fill the sealing component and the expandable filling structure. In some examples, when deployed, the expandable filling structure at least partially surrounds the proximal ends of the second graft and the third graft that are docked within the single lumen of the first graft. In some examples, the expandable filling structure is coupled to the first graft. In some examples, the second graft and the third graft are docked within the single lumen of the first graft located in the docking area. In the expanded state, the expandable filling structure surrounds at least the portions of the second graft and the third graft that are located outside the docking area. In some examples, the expandable filling structure is coupled to the first graft. When deployed, the expandable filling structure, in the expanded state, surrounds the portions of the second graft and the third graft that are located within the iliac arteries.

[0012] In some examples, the second and third grafts are docked within a single lumen of the first graft located in the docking region. The first graft includes a supporting expandable filling structure coupled to a portion of the first graft located in the docking region. The supporting expandable filling structure expands to provide structural integrity to the first graft. In some examples, the supporting expandable filling structure expands before or simultaneously with the expansion of the expandable filling structure. In some examples, the second and third grafts are docked within the single lumen of the first graft located in the docking region. The first graft includes a wire stent component coupled to a portion of the first graft located in the docking region. The wire stent component includes a plurality of wire loops. In some examples, the single lumen of the first graft is open at the wire stent component. In some examples, the second and third grafts are docked within the single lumen of the first graft located in the docking region. The first graft includes a wire stent loop coupled to a portion of the first graft located in the docking region, the wire stent loop comprising a single loop of the wire stent.

[0013] In some examples, the expandable filling structure is more compliant than the sealing component. In some examples, the expandable filling structure forms a funnel shape in the expanded state. In some examples, the expandable filling structure forms a funnel shape by having a portion of the expandable filling structure adjacent to the wall of the aorta extend further along the wall of the aorta than another portion of the expandable filling structure adjacent to or adjacent to the first graft. In some examples, the expandable filling structure is a bifurcated expandable filling structure that, in the expanded state, forms two lumens for receiving the second graft and the third graft.

[0014] In some arrangements, the stent-graft system further comprises: 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 independent expandable filling structures that expand within the aorta during deployment. In some examples, the first expandable filling structure expands into a single lumen of the first graft.

[0015] In some examples, 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 examples, 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.

[0016] In some arrangements, the stent-graft system further comprises an expandable filling structure coupled to the first graft. When in an expanded state, the expandable filling structure forms a seal in the proximal neck region of the aorta. The second graft and the third graft dock within a single lumen of the first graft in the docking region. When in an expanded state, the expandable filling structure surrounds at least portions of the second graft and the third graft that are located outside of the docking region. When in an expanded state, the expandable filling structure at least partially surrounds the first graft.

[0017] In some arrangements, the stent graft system further comprises: a first expandable filling structure that at least partially surrounds the second graft; and a second expandable filling structure that at least partially surrounds the third graft. Upon deployment, the first expandable filling structure and the second expandable filling structure expand within the aorta and at least partially surround the first graft. In some examples, each of the second graft and the third graft comprises a wire-wound stent component. The wire-wound stent component comprises a plurality of wire-wound loops. In some examples, the first expandable filling structure and the second expandable filling structure are secured to portions of the second graft and the third graft that are 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. In some examples, the first expandable filling structure and the second expandable filling structure expand into the lumen of the first graft.

[0018] In some arrangements, the second graft and the third graft are docked within a single lumen of the first graft located in the docking region. The first graft includes at least one supporting expandable filling structure that is coupled to a portion of the first graft located in the docking region. When the second graft and the third graft are inserted into the single lumen of the first graft located in the docking region, the second graft and the third graft are inserted into an opening in each of the at least one supporting expandable filling structure. The at least one supporting expandable filling structure provides a seal within the lumen of the first graft relative to the first graft, the second graft, and the third graft. In some examples, the opening has a bi-lobe shape.

[0019] In some arrangements, the second graft and the third graft are docked within a single lumen of the first graft located in the docking region. The first graft includes at least one internal support member coupled to a portion of the first graft located in the docking region. The internal support member 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 located in the docking region. In some arrangements, the first graft includes a sealing member coupled to a distal end of the first graft.

[0020] In some arrangements, the second graft and the third graft are docked within a single lumen of the first graft in the docking region. The first graft includes an internal expandable filling structure coupled to the first graft in the docking region. The internal expandable filling structure expands within the single lumen of the first graft upon expansion 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 in the docking region. The internal expandable filling structure forms a bifurcated lumen.

[0021] In some examples, the bifurcated cavity is formed by inflating a proximal portion of the inner expandable filling structure around a first balloon having a circular or elliptical cross-section and inflating a distal portion of the inner expandable filling structure around a second balloon having a bivalve cross-section.

[0022] In some arrangements, the first graft comprises a laminated stent component. In some examples, the laminated stent component comprises a Teflon laminated nickel titanium (NiTi) stent.

[0023] In some arrangements, the stent-graft system includes an anchor configured to attach the first graft to the aorta. The anchor includes a hook or a barb. In some arrangements, the anchor is positioned on a stent ring of the first graft. In some arrangements, the first graft includes a support structure coupled to the first graft, the support structure being positioned within the lumen of the first graft. In some examples, the support structure includes a helical polymer support ring.

[0024] In some arrangements, the stent graft system includes: a graft forming a cavity; and at least one support member embedded in the graft. Each of the at least one support member is a polymer ring surrounding the graft. At least a portion of each of the at least one support member is coupled to an outer surface of the graft, the outer surface facing away from the cavity. In some examples, the at least one support member includes a first support member and a second support member. The first support member is positioned at a first end of the graft. The second support member is positioned at a second end of the graft. In some examples, the at least one support member includes three or more support members spaced apart from each other along the graft. In some examples, the graft further forms a bifurcation feature, the bifurcation feature including two additional cavities that receive limb stent grafts. In some examples, the graft further includes an inner sleeve or ring positioned in the cavity that receives the limb stent graft.

[0025] In some arrangements, a system includes: a proximal extension expandable filling structure that forms a seal in the proximal neck region of the aorta when the proximal extension expandable filling structure is expanded. The system also includes at least one cavity formed by the proximal extension expandable filling structure when the proximal extension expandable filling structure is expanded. Each of the at least one cavity receives a branch stent graft, and the at least one cavity is positioned in the proximal neck region when the proximal extension expandable filling structure forms a seal in the proximal neck region. In some arrangements, the system also includes an anchor that is connected 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 endobag (endobag). BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a cross-sectional view of an example infrarenal aortic aneurysm in a patient.

[0027] Figure 2 are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements.

[0028] Figure 3A are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements. Figure 3B are example stent graft systems deployed across aneurysms according to various arrangements ( Figure 3A ) is another cross-sectional view.

[0029] Figure 4Aare cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements. Figure 4B are example stent graft systems deployed across aneurysms according to various arrangements ( Figure 4A ) is another cross-sectional view.

[0030] Figure 5 are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements.

[0031] Figure 6A are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements. Figure 6B are example stent graft systems deployed across aneurysms according to various arrangements ( Figure 6A ) is another cross-sectional view.

[0032] Figure 7 are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements.

[0033] Figure 8 are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements.

[0034] Figure 9 are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements.

[0035] Figure 10 are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements.

[0036] Figure 11A are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements. Figure 11B are example stent graft systems deployed across aneurysms according to various arrangements ( Figure 11A ) is another cross-sectional view.

[0037] Figure 12 are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements.

[0038] Figure 13A are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements. Figure 13B are example stent graft systems deployed across aneurysms according to various arrangements ( Figure 13A ) is another cross-sectional view.

[0039] Figure 14 are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements.

[0040] Figure 15Ais deployed in aneurysms according to various arrangements ( Figure 1 ) is a cross-sectional view of an example stent graft system. Figure 15B is deployed in aneurysms according to various arrangements ( Figure 1 ) on an example stent graft system ( Figure 15A ) is another cross-sectional view. Figure 15C is deployed in aneurysms according to various arrangements ( Figure 1 ) on an example stent graft system ( Figure 15A ) is another cross-sectional view.

[0041] Figure 16 are cross-sectional views of example stent graft systems deployed on an aneurysm according to various arrangements.

[0042] Figure 17 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system.

[0043] Figure 18 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system.

[0044] Figure 19 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system.

[0045] Figure 20A 、 Figure 20B 、 Figure 20C 、 Figure 20D 、 Figure 20E 、 Figure 20F 、 Figure 20G 、 Figure 20H 、 Figure 20I 、 Figure 20J 、 Figure 20K and Figure 20L Examples of proximal implants according to various arrangements are shown.

[0046] Figure 21A 、 Figure 21B 、 Figure 21C and Figure 21D Examples of stent grafts according to various arrangements are shown.

[0047] Figure 22A Example proximally extending expandable filling structures of stent graft systems are shown according to various arrangements.

[0048] Figure 22B is deployed in the aneurysm 14 ( Figure 1 ) on the stent graft system ( Figure 22A) cross-sectional view.

[0049] Figure 23 Example proximally-extending expandable structures of stent graft systems are shown according to various arrangements. DETAILED DESCRIPTION

[0050] Various arrangements are described below. It should be noted that the specific arrangements are not intended as exhaustive descriptions or as limitations on the broader aspects discussed herein. An aspect described in conjunction with a specific arrangement is not necessarily limited to that arrangement and can be practiced with any other arrangement.

[0051] Various arrangements disclosed herein relate to a stent-graft system comprising: a single-lumen proximal graft coupled to an expandable filling structure (e.g., an endobag); and a branch stent-graft (branch) that can be coupled to one or more expandable filling structures. Such a stent-graft system includes one or more additional expandable filling structures (e.g., those coupled to the branch) for sac management. Sac management refers to the management of support within the aneurysm sac. An anchor (e.g., a component used to secure or attach the stent-graft system to the aorta) is separate from the sealing component and separate from the sac management component (e.g., the expandable filling structure), resulting in a more robust design compared to other stent-graft system designs. In some embodiments, the sealing component coupled to the proximal graft is appropriately sized (e.g., by including a wide sealing ring), which improves placement accuracy. In some embodiments, the stent-graft system includes a large single-lumen proximal graft (e.g., having a large pore size) that is easier to cannulate than other devices (e.g., stent-graft systems having a graft component with a bifurcated lumen), thereby requiring less surgical time and fluoro time than other devices. Various arrangements of the stent-graft system are also less expensive to manufacture than other devices (e.g., devices having a graft component with a bifurcated lumen) because a single-lumen proximal graft is less expensive to manufacture than a graft with a bifurcated lumen.

[0052] Various arrangements disclosed herein relate to a stent graft system comprising a proximal graft having a proximal suprarenal self-expanding stent having a fixation feature coupled to a dual-lumen polymer-filled expandable filling structure (e.g., a dual-lumen polymer-filled endobag). Compared to current AAA devices, the disclosed stent graft system includes a customized neck seal and a proximal fixation portion that is fixed to the bladder management features of the stent graft system. For example, the disclosed stent graft system separates the proximal fixation portion, the neck seal, the cuff-to-stent graft seal, and the stent graft-to-sac seal. Furthermore, by having a wide sealing area below the fixation feature (e.g., the fixed stent frame), the sealing component (e.g., the cuff) of such a stent graft system is appropriately sized, thereby improving placement accuracy. In some embodiments, a separate neck seal (e.g., a customized neck seal) can generate a higher sealing pressure than the seals of other stent graft systems, allowing the neck seal to last longer.

[0053] In some cases, the more design requirements or functions are imposed on a design feature of a stent graft system (e.g., a discrete, independent component), the less efficient the design feature becomes. Various arrangements of the stent graft systems described herein include independent design features or components for fixation, sealing, and balloon management.

[0054] Some arrangements of the stent-graft system include a proximal graft that is a single lumen, referred to herein as a single lumen proximal graft. The aperture and total length of the single lumen proximal graft are similar to the diameter and total length of the aorta body. The single lumen proximal graft is less complex as a structure / component and is easier to manufacture than the bifurcated lumen. The unsupported portion of the single lumen proximal graft has sufficient length (e.g., approximately 30 mm) and is located above the branch edge (the branch edge is inside the single lumen proximal graft) for emergency rescue surgery (e.g., deploying a Palmaz stent inside the single lumen proximal graft) or for enhancement from the stent-graft system to treat complex AAA and TAA.

[0055] In some arrangements, the proximal graft comprises a suprarenal laser-cut stent with a coil attached thereto. In some examples, the suprarenal stent has a shorter stent than some current stent graft systems to eliminate a free crown. A shorter stent allows for a larger neck angle due to improved stent graft flexibility. Thus, the suprarenal stent in the stent graft system disclosed herein is shorter and has fewer crowns and fewer anchors, which allows the stent graft system to be used for smaller treatment sizes. That is, the stent graft system described herein is a low-profile delivery system for small treatment sizes.

[0056] In some arrangements, the sealing component includes a wider polytetrafluoroethylene (PTFE) polymer sealing ring compared to the sealing rings on other devices. Given that the wider sealing ring can still provide a tight seal in the neck of the aorta even if the stent graft system is placed in a position lower than the optimal position (e.g., 1 mm lower), the wider sealing ring improves placement accuracy. In addition, the wider sealing ring has a wider treatment diameter range, which means that a smaller number of sealing ring sizes (and a smaller number of stock keeping units (SKUs)) are required to treat the entire vascular treatment range. In some arrangements, the neck length of the aortic neck region in which the sealing component is configured to be deployed can be shorter than the neck length in which the sealing components of other devices are configured to be deployed. In addition, the wide sealing ring can improve neck angle indication.

[0057] In some arrangements, the proximal graft includes an inflatable filling structure (e.g., an endobag) attached thereto. For sac management, the inflatable filling structure is deployed at a position below the sealing member (in the distal direction of the sealing member). 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 same filling port is used to fill the inflatable filling structure and the sealing member, thereby reducing the delivery system profile.

[0058] In some examples, the expandable filling structure can be made of PTFE or low-hardness polyurethane. In some cases, PTFE is used for the expandable filling structure, given that PTFE can be heat-bonded to the PTFE holes of the proximal graft and / or the PTFE holes of the sealing component. In some examples where the expandable filling structure is made of PTFE, given that PTFE has less elasticity, a larger expandable filling structure is achieved, wherein such a large expandable filling structure can increase the device profile. On the other hand, in some examples where the expandable filling structure is made of polyurethane, given that polyurethane has greater elasticity than PTFE, the expandable filling structure (made of polyurethane) requires less material than the material required for the expandable filling structure made of PTFE, wherein less material can reduce the device profile. However, polyurethane cannot be easily heat-bonded to the PTFE proximal graft and / or the PTFE sealing component. Therefore, if 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 can enter the space between the hole of the proximal graft and the lumen of the expandable filling structure, thereby pressurizing the lumen.

[0059] With respect to docking, the distal proximal graft section in which the limbs are docked has a hole size that is universal for all proximal graft sizes so that the proximal graft can taper in or out to the desired vessel size. In various arrangements, the proximal graft is supported by a wire-wound stent to avoid kinking the proximal graft lumen in angled anatomical structures. In some arrangements, the distal proximal graft universal docking section is supported by a wire-wound stent for docking the limbs with sufficient radial force to minimize the possibility of displacement between the proximal graft and the limbs, thereby minimizing type III endoleak (endolar fistula). With respect to the unsupported proximal graft, another expandable filling structure (e.g., a balloon placed inside the proximal graft) can be used as an expandable filling structure (e.g., an inner bag), which is filled to avoid collapse of the proximal graft. In some examples, the balloon can be integrally formed with the proximal graft delivery system. That is, the balloon can be filled using a catheter for filling the proximal graft. Alternatively, the balloon may be inflated using a catheter separate from the catheter used for the proximal graft delivery system.

[0060] In some arrangements, the branches described herein can be self-expanding PTFE-covered stents or balloon-expandable PTFE-covered stents. Self-expanding PTFE-covered stents have sufficient radial structural integrity (e.g., radial force) to prevent luminal collapse during filling of the expandable filling structure (e.g., endobag). On the other hand, balloon-expandable PTFE-covered stents require a balloon to expand the stent. As such, the self-expanding PTFE-covered stent has a smaller device profile than the device profile of the balloon-expandable PTFE-covered stent.

[0061] With respect to fixation (e.g., docking, deployment, insertion, etc.) in which the proximal graft is coupled to the limbs, in some arrangements, the limb diameter of at least one limb docked or to be docked in the docking region (or overlapping region) is smaller than the diameter of the proximal graft's aperture. In such examples, an expandable structure (e.g., an inner bag) around each limb inside the docking region can seal a gutter that typically exists when docking at least one limb inside a larger aperture. In an alternative arrangement, the sum of the limb diameters of at least one limb docked or to be docked in the docking region is greater than the diameter of the proximal graft's aperture. In an example in which two limbs are docked in the docking region, the cross-sections of the two limbs are compressed into a D-shape inside the proximal graft's aperture, creating a resistance to disengagement due to the radial forces exerted by the limbs on the proximal graft's aperture. In such an arrangement, each limb can include an expandable filling structure (e.g., an inner bag) in the docking region to seal any remaining gutter.

[0062] With respect to sac management, in various arrangements, the limb has an expandable filling structure (e.g., an endobag) that is attached to the PTFE covered stent of the limb. The expandable filling structure can cover the entire length of the limb, including the portion of the limb that is located in the docking area of ​​the proximal graft. The expandable filling structure can seal the aneurysm sac and form a seal in the distal iliac end. In some arrangements, the expandable filling structure for the proximal graft and / or limb can be optional, depending on whether a Type II endoleak is present.

[0063] Figure 1 is a cross-sectional view of an example infrarenal aortic aneurysm 14 in a patient. Figure 1 , the aorta 10 branches into two iliac arteries 12 and 13 at the aortic bifurcation 11. The sac of the aneurysm 14 corresponds to the bulge section of the aorta 10. The infrarenal aortic aneurysm 14 is located below the renal arteries 15 and 16 (in the distal direction relative to the renal arteries). The section of the aorta 10 located between the renal arteries 15 and 16 and the sac of the aneurysm 14 is called the proximal neck region 17. The proximal neck region 17 has different diameters 83 for different patients. Typically, a mural thrombus 18 forms on the inner wall of the sac of the aneurysm 14. For clarity, the mural thrombus 18 may be omitted in other figures.

[0064] Reference Figure 1 The size of aneurysm 14 can vary significantly from patient to patient. For example, the diameter of the proximal neck region 17 can vary from 18 mm to 34 mm. For example, the distance from the aortic bifurcation 11 to the renal arteries 15 and 16 can vary from 80 mm to 160 mm. The diameters of the left and right iliac arteries 12 and 13 can be different. For example, the diameters of the iliac arteries 12 and 13 at the aortic bifurcation 11 can vary from 8 mm to 20 mm. One or both of the iliac arteries 12 and 13 can have an aneurysm with a greatly increased diameter (e.g., greater than 30 mm).

[0065] Figure 2 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 200. Figure 1 and Figure 2 Stent graft system 200 is an endovascular graft system, an infrarenal prosthesis, etc. Stent graft system 200 includes a proximal graft 212 , a first branch stent graft 214 a , a second branch stent graft 214 b , an expandable filling structure 230 , a sealing member 240 , and an anchor 245 .

[0066] In some examples, in some arrangements, the proximal graft 212 can be a graft component made of a graft material 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 that is closer to or located in the proximal neck region 17 when deployed. As shown, the proximal end of the proximal graft 212 can be placed in the proximal neck region 17 when deployed. The distal end of the proximal graft 212 is the end of the proximal graft 212 that is closer to the aortic bifurcation 11 when deployed. As shown, the distal end of the proximal graft 212 can be placed into the sac of the aneurysm 14, which is located 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 away from the tubular lumen of the proximal graft 212.

[0067] In some arrangements, the branch stent grafts 214a and 214b may be referred to as branches. In some examples, each branch stent graft described herein (e.g., branch stent grafts 214a and 214b) comprises a graft material having a stent. In other examples, the branch stent graft may simply be a graft material without a stent. Each branch stent graft 214a and 214b may be a self-expanding PTFE-covered stent or a balloon-expandable PTFE-covered stent. Each first branch stent graft 214a and second branch stent graft 214b has a proximal end, a distal end, and an outer surface. The proximal end of each branch stent graft 214a and 214b is the end of each branch stent graft 214a and 214b that is closer to the proximal neck region 17 when deployed. As shown, the proximal ends of the branch stent grafts 214a and 214b may be placed in the sac of the aneurysm 14. The distal end of each branch stent-graft 214a and 214b is the end of each branch stent-graft 214a and 214b that is closer to or located in the iliac arteries 12 and 13. As shown, the distal end of the first branch stent-graft 214a can be positioned in the iliac artery 12 during deployment, and the distal end of the second branch stent-graft 214b can be positioned in the iliac artery 13 during deployment. Branch stent-grafts 214a and 214b can be arranged at or adjacent to the aortic bifurcation 11. The outer surface of each branch stent-graft 214a and 214b faces the wall / surface of the aorta 10 and faces away from the tubular lumen of each branch stent-graft 214a and 214b.

[0068] Stent-graft system 200 can be deployed over aneurysm 14 in any suitable manner. In one example, the distal ends of branch 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 branch stent-grafts 214a and 214b, such that the proximal ends of branch stent-grafts 214a and 214b are inserted into the tubular lumen of the distal end of proximal graft 212. The portions of branch stent-grafts 214a and 214b inserted into proximal graft 212 and the portions of proximal graft 212 surrounding branch stent-grafts 214a and 214b are located in docking region 250 (i.e., the overlapping region or distal proximal graft common docking section where proximal graft 212 and branch stent-grafts 214a and 214b overlap). When the distal end of the proximal graft 212 is placed over the branch stent grafts 214a and 214b, the proximal end of the proximal graft 212 is placed in the proximal neck region 17. In this way, the proximal graft 212 can extend the aneurysm repair into the proximal neck region 17.

[0069] In some examples, expandable filling structure 230 can be made of PTFE, low-durometer polyurethane, or the like. In some cases, PTFE is used for expandable filling structure 230 because it can be thermally bonded to the PTFE pores of proximal graft 212 and / or the PTFE pores of sealing component 240. In some examples where expandable filling structure 230 is made of PTFE, due to the lower elasticity of PTFE, a larger expandable filling structure 230 can be implemented, which can increase the device profile. On the other hand, in some examples where expandable filling structure 230 is made of polyurethane, due to the greater elasticity of polyurethane compared to PTFE, less material is required to make the expandable filling structure 230 from polyurethane. This reduced material requirement can reduce the device profile. However, polyurethane cannot be easily thermally bonded to the PTFE proximal graft 212. Therefore, if polyurethane is used for expandable filling structure 230, the polyurethane of expandable filling structure 230 is sutured to the PTFE proximal graft 212. In some cases, blood may enter the space between the pores of proximal graft 212 and the lumen of expandable filling structure 230, thereby pressurizing the lumen.

[0070] The expandable filling structure 230 can be filled with a filling medium using an expandable channel, filling structure, or filling line. Examples of filling media include, but are not limited to, polyester, PTFE, polyurethane, and the like. When the expandable filling structure 230 is fully filled with the filling medium, the expandable filling structure 230 is in a filled or expanded state. When the expandable filling structure 230 is not filled with any filling medium, the expandable filling structure 230 is in an unfilled or unexpanded state. In the expanded state, the expandable filling structure 230 surrounds at least a portion of the proximal graft 212. As shown, when deployed, the expandable filling structure 230 (in the expanded state) surrounds the portion of the proximal graft 212 located within 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 expanded state) does not surround any portion of the proximal graft 212 located within the proximal neck region 17. For sac management, the expandable filling structure 230 is deployed (in a distal direction from the sealing member) below the sealing member 240. In the expanded state, expandable filling structure 230 surrounds at least the distal end of proximal graft 212. In various examples, expandable filling structure 230 is an inner bag secured to a portion of the outer surface of proximal graft 212 and includes an outer membrane that, when expandable filling structure 230 is in the expanded state, does not extend beyond the distal end of proximal graft 212. In other words, expandable filling structure 230 (in the expanded state) does not surround any portions of tributary stent-grafts 214a and 214b that are not inserted into proximal graft 212 when stent-graft system 200 is deployed.

[0071] When the proximal graft 212 is placed over the branch stent grafts 214a and 214b, the expandable filling structure 230 is secured to a portion of the outer surface of the proximal graft 212 and is initially in an unexpanded state. Next, the expandable filling structure 230 is filled with a filling medium to achieve an expanded state. When the expandable filling structure 230 is filled, a portion of the expandable filling structure 230 extends and expands radially into the space of the sac of the aneurysm 14 adjacent to the proximal graft 212. When in the unexpanded state, the expandable filling structure 230 can be confined around the proximal graft 212, and when in the expanded state as shown, the expandable filling structure 230 expands radially and proximally to fill the entire (or a majority of) aneurysm 14 between the distal end of the proximal graft 212 and the lower boundary of the proximal neck region 17. When the expandable filling structure 230 is in the filled state, the filling medium pushes the wall (e.g., adventitia) of the expandable filling structure 230 against the wall / surface of the aneurysm 14. When expandable filling structure 230 is in the filled state, expandable filling structure 230 can conform to the wall / surface of aneurysm 14 and a portion of the outer surface of proximal graft 212 .

[0072] The proximal graft 212 and the branch stent grafts 214a and 214b (prior to deployment) are separate grafts that are connected, joined, or otherwise joined together when deployed in the manner described. Each of the proximal graft 212 and the branch stent grafts 214a and 214b is a single lumen graft. Single lumen grafts are less complex as structures / components and are easier and cheaper to manufacture than bifurcated lumen grafts. In some embodiments, the proximal graft 212 has a large pore size, which is easier to cannulate than other devices with bifurcated lumen grafts and therefore requires less surgical time and fluorescence time than such other devices. The pore size and total length of the single lumen proximal graft 212 are similar to the pore size and total 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 (outside the docking region 250 and above and proximal to the proximal edges / ends of the limb stent-grafts 214a and 214b located within the single lumen proximal graft 212 when deployed in the manner described) has sufficient length (e.g., approximately 30 mm) to be used for emergency rescue procedures (such as, but not limited to, deploying a Palmaz stent within the single lumen proximal graft) or augmentation from the stent-graft system 200 to treat complex AAAs and TAAs.

[0073] In various configurations, anchor 245 (fixation feature, fixed stent frame, etc.) anchors, secures, or attaches the proximal end of stent-graft system 200 (e.g., proximal graft 212) to the wall / surface of aorta 10, preventing blood from invading the area between the outer wall and inner surface of aneurysm 14 and improving the transition from the tubular lumen of aorta 10 to proximal graft 212. In some examples, anchor 245 may comprise a stent, graft, and / or other expandable luminal support structure. In some examples, anchor 245 comprises a suprarenal laser-cut stent with a coil attached thereto. In some examples, anchor 245 has a shorter stent than some current stent-graft systems to eliminate a free crown. A shorter stent allows for a greater neck angle due to the improved flexibility of the stent-graft. Thus, anchor 245's suprarenal stent is shorter and has fewer crowns and fewer anchors, thereby allowing stent-graft system 200 to be used in smaller treatment sizes. That is, stent graft system 200 is a low-profile delivery system that can be used for small treatment sizes.

[0074] In some examples, the anchor 245 is a stent-like support structure that can be implanted at the end of the proximal end of the upper proximal opening of the tubular lumen or the proximal end of the proximal graft 212. As shown, the anchor 245 extends from the proximal end of the proximal graft 212 in a proximal direction. When deployed, the anchor 245 can extend from a position on the interior or boundary of the proximal neck region 17 and extend above the opening to the renal arteries 15 and 16 (e.g., the renal ostium). The anchor 245 includes a hook or barb that anchors, fixes, or attaches to the wall / surface of the aorta 10, which is proximal relative to the renal ostium and the proximal neck region 17. The anchor 245 includes an opening or port to allow infiltrated blood to flow into the renal arteries 15 and 16. As shown, since the anchor 245 has a stent-like support structure, blood can flow into the renal arteries 15 and 16 through the unobstructed renal ostium.

[0075] Each graft 212, 214a, and 214b can include one or more fill lines or expandable channels through which a hardenable expansion material or filling polymer is circulated in liquid form. In some arrangements, each graft 212, 214a, and 214b can include one or more circumferential expandable channels that extend around the periphery of the graft body of each graft 212, 214a, and 214b, or can extend partially around the periphery of the graft body of each graft 212, 214a, and 214b. In some embodiments, the expandable channels can be fluidically connected to each other via longitudinal expandable filling channels in the graft body. The network of expandable channels can be filled with a hardenable material that hardens, solidifies, or otherwise increases in viscosity or becomes more rigid after being injected into the channels. By virtue of the mechanical properties of the hardening material disposed within the channel, a hardenable expandable material (such as a gel, liquid, or other flowable material that cures to a more solid or substantially hardened state) can be used to provide mechanical support to the graft body of each graft 212, 214a, and 214b. In some arrangements, the filler is saline. In some arrangements, the filler is a gas.

[0076] In some embodiments, the sealing member 240 (e.g., a cuff, a stand-alone neck seal, a custom neck seal, etc.) can be an expandable sealing ring. The sealing member 240 accommodates various sizes of the aorta 10, for example, particularly various dimensional variations of the proximal neck region 17. In some examples and as Figure 2As shown, when in the expanded state, the sealing member 240 continuously contacts the inner wall of the proximal neck region 17 to provide a continuous seal at the proximal neck region 17. Continuously contacting the inner wall of the proximal neck region 17 refers to the fact that, when in the expanded state, the sealing member 240 contacts the inner wall sufficiently to form a fluid-tight seal therewith, or continuously contacts the entire inner wall, with all portions of the sealing member 240 being in contact with the inner wall of the proximal neck region 17.

[0077] In some embodiments, sealing member 240 is coupled to proximal graft 212. For example, sealing member 240 is attached, fixed, or otherwise coupled to an outer surface of proximal graft 212. When proximal graft 212 is deployed, sealing member 240, in the expanded state, surrounds a portion of proximal graft 212 located in proximal neck region 17. Sealing member 240 is located at or near the proximal end of proximal graft 212. In some examples, when sealing member 240 is in the expanded state, sealing member 240 does not reach or extend beyond the edge of the proximal end of proximal graft 212, such that a portion of proximal graft 212 adjacent to the edge of the proximal end of proximal graft 212 is not surrounded by sealing member 240. In other examples, when sealing member 240 is in the expanded state, sealing member 240 reaches or extends beyond the edge of the proximal end of proximal graft 212.

[0078] Graft materials used in stent-graft system 200 include, but are not limited to, polyester, PTFE, polyurethane, and the like. In some arrangements, each graft 212, 214a, and 214b is a stent covered in a graft material. In some arrangements, sealing member 240 has or communicates with a fill line or expandable channel through which a hardenable expansion material or filling polymer (e.g., polyester, PTFE, polyurethane, and the like) is circulated in liquid form.

[0079] In some examples, sealing component 240 utilizes different expandable channels and fill ports than those used by the rest of stent-graft system 200. That is, sealing component 240 does not share expandable channels or fill ports with other components (e.g., grafts 212, 214a, and 214b, expandable filling structure 230, etc.) Thus, when stent-graft system 200 is deployed, at least a first expandable channel coupled to expandable filling structure 230 and a first fill port on expandable filling structure 230 are used to inject a fill polymer into expandable filling structure 230, and a second expandable channel coupled to sealing component 240 and a second fill port on sealing component 240 are used to inject a fill polymer into sealing component 240.

[0080] In some examples where sealing member 240 is expanded using a dedicated expandable channel that is not shared with another component of stent-graft system 200 (e.g., expandable filling structure 230), sealing member 240 (using the dedicated expandable channel) is inflated to a pressure and uses the pressure that is higher than the pressure at which expandable filling structure 230 is filled, for example, using the expandable channel of expandable filling structure 230. In some examples, expandable filling structure 230 is inflated to a lower pressure (e.g., approximately 120 mmHg-180 mmHg) and uses the lower pressure, which may not be sufficient to fully inflate sealing member 240. Because sealing member 240 is filled to a higher pressure (e.g., 180 mmHg-760 mmHg) and uses the higher pressure, sealing member 240 can prevent expandable filling structure 230 from prolapsing into renal arteries 15 and 16 when expandable filling structure 230 is expanded. In that case, sealing member 240 is inflated before expandable filling structure 230 is expanded. The sealing member 240 (which is filled to a higher pressure to form a seal at the proximal neck region 17) acts as a stopper that prevents the expandable filling structure 230 from prolapsing through the proximal neck region 17 into the renal arteries 15 and 16. In addition, because the sealing member 240 contacts healthy tissue, the sealing member 240 can be filled at a higher pressure, which can be manipulated for sealing and anchoring purposes. On the other hand, the expandable filling structure 230 contacts the aneurysm sac (unhealthy tissue) and should therefore be filled at a lower pressure.

[0081] In other examples, sealing component 240 can use an expandable channel and filling port that are also used by another component (e.g., expandable filling structure 230 of stent-graft system 200). That is, sealing component 240 shares the expandable channel and filling port with another component (e.g., expandable filling structure 230, etc.) of stent-graft system 200. If the expandable channel and filling port are shared, the device profile and delivery system profile can be reduced.

[0082] In some arrangements, sealing member 240 is a wide PTFE polymer sealing ring. The PTFE polymer sealing ring of sealing member 240 is wider than the sealing rings in other devices. In one example, sealing member 240 (in the expanded state and fully deployed in the proximal neck region 17) is at least 10 mm wide along the longitudinal dimension of aorta 10 (e.g., in the proximal-distal direction). The wider sealing ring of sealing member 240 improves placement accuracy, as the wider sealing ring of sealing member 240 can still provide a sufficiently tight seal in the proximal neck region 17 even if stent-graft system 200 (e.g., proximal graft 212 and sealing member 240) is positioned lower than the optimal position (e.g., 1 mm lower). The optimal position corresponds to a position of stent-graft system 200 that allows sealing member 240 (in the expanded state) to be completely within the proximal neck region 17 (and not within the sac of aneurysm 14) when stent-graft system 200 is deployed in the manner described. Given that the width / radius of the sac of aneurysm 14 is greater than the width / radius of proximal neck region 17, the portion of sealing component 240 located outside proximal neck region 17 and inside the sac of aneurysm 14 may not form a tight seal with the sac wall. Because sealing component 240 comprises a wide sealing ring, although the portion of sealing component 240 located outside proximal neck region 17 and inside the sac of aneurysm 14 may not form a tight seal, even if stent-graft system 200 (e.g., proximal graft 212 and sealing component 240) is positioned lower than the optimal position, the majority of sealing component 240 is still located inside proximal neck region 17. The portion of sealing component 240 located inside proximal neck region 17 can still provide a sufficiently tight seal. Thus, even if stent-graft system 200 is positioned lower than the optimal position, the placement can still be considered accurate because sealing component 240 can still provide a sufficiently tight seal.

[0083] In addition, the wider sealing ring of the sealing component 240 has a wider range of treatment diameters. Thus, a smaller number of different treatment diameter ranges are required for the wider sealing ring. This means that a smaller number of sealing ring sizes and a smaller number of SKUs corresponding to those sealing ring sizes are required to treat the entire range of vessel treatments (e.g., to cater to patients with proximal neck regions 17 of different sizes). In one example, once the sealing component 240 radially expands (when filled) to the point where the sealing component 240 contacts the inner wall of the proximal neck region 17, the sealing component 240 expands longitudinally in the proximal neck region 17. This allows the sealing component 240 to be applied to a wider range of vessel sizes. Therefore, fewer sizes of sealing components 240 need to be manufactured, and flexibility and cost are improved. In addition, the wide sealing ring can improve neck angle indication.

[0084] As shown, anchor 245 (for securing or attaching to aorta 10), sealing member 240 (for sealing proximal neck region 17), and expandable filling structure 230 (for balloon management) are independent components. That is, each of anchor 245, sealing member 240, and expandable filling structure 230 has a single, respective function, thereby achieving a more robust design compared to other stent graft system designs.

[0085] Figure 3A is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 300. Figure 3B is deployed in the aneurysm 14 ( Figure 1 ) on an example stent graft system 300 ( Figure 3A ) another cross-sectional view. Figures 1-3B , stent-graft system 300 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, expandable filling structure 330, sealing member 240, and anchor 245. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing member 240, and anchor 245 are components of stent-graft system 300 that are similar to corresponding components of stent-graft system 200 and provide similar improvements. Additionally, when deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can be docked in proximal graft 212 (e.g., in docking region 250) in the manner described. As shown, Figure 3B is a cross-sectional view of a stent graft system 300, which is shown in FIG. Figure 3A The docking area 250 is shown cut away.

[0086] In some examples, the branch diameters of first and second branch stent-grafts 214a, 214b (in docking region 250) are substantially smaller than the diameter of the pore of the lumen of proximal graft 212. In such examples, when branch stent-grafts 214a and 214b dock into the larger pore of proximal graft 212, a groove 302 is typically present in docking region 250. Expandable filling structure 330 is shaped to seal such groove 302. Expandable filling structure 330 is similar to expandable filling structure 230, except that expandable filling structure 330 is shaped to extend into the sac of aneurysm 14 and surround each branch stent-graft 214a and 214b (including portions of branch stent-grafts 214a and 214b located outside of docking region 250) when deployed. After the branch stent-grafts 214a and 214b are docked within the single lumen of the proximal graft 212, the expandable filling structure 330 is filled via the fill line 301. As shown, when filled to the expanded state, the expandable filling structure 330 (which is fixed, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212) can extend in a distal direction toward the iliac arteries 12 and 13 and the aortic bifurcation 11 to surround the branch stent-grafts 214a and 214b while radially pushing against the surface / wall of the sac of the aneurysm 14. The branch stent-grafts 214a and 214b do not have any expandable filling structure fixed, bonded, attached, or otherwise coupled thereto. Thus, the expandable filling structure 330 can (by surrounding the branch stent-grafts 214a and 214b) close the groove 302 and fill the aneurysm sac from the proximal neck region 17 to the aortic bifurcation 11. In some examples (not shown), expandable filling structure 330 can even extend into iliac arteries 12 and 13 while surrounding the portion of branch stent-grafts 214a and 214b located within iliac arteries 12 and 13. Thus, to seal the entire sac of aneurysm 14 (including groove 302 and sometimes even iliac arteries 12 and 13), only one component (expandable filling structure 330) is required, along with only one filling line (filling line 301) and one filling procedure, resulting in a shorter procedure time. Since branch stent-grafts 214a and 214b do not have any expandable filling structure, stent-graft system 300 is also less expensive.

[0087] Figure 4A is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 400. Figure 4B is deployed in the aneurysm 14 ( Figure 1 ) on an example stent graft system 400 ( Figure 4A ) another cross-sectional view. Figure 1 、 Figure 2 and Figure 4A-4B , stent-graft system 400 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, expandable filling structures 430, 432, and 434, and anchor 245. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, and anchor 245 are components of stent-graft system 400 that are similar to corresponding components of stent-graft system 200 and provide similar improvements. Additionally, when deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can dock in proximal graft 212 (e.g., in docking region 250) in the manner described. As shown, Figure 4B is a cross-sectional view of a stent graft system 400, which is shown in FIG. Figure 4A The docking area 250 is shown cut away.

[0088] Expandable filling structure 430 is fixed, bonded, attached, or otherwise coupled to the outer surface of proximal graft 212. In some examples, expandable filling structure 430 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of proximal graft 212, except for a portion of the outer surface of proximal graft 212 adjacent to the edge of the proximal end of proximal graft 212. In other examples, expandable filling structure 430 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of proximal graft 212. In some examples, in the expanded state, expandable filling structure 430 surrounds the outer surface of proximal graft 212 (when deployed in aorta 10), including the portion of proximal graft 212 located in proximal neck region 17 and within the sac of aneurysm 14. Thus, stent-graft system 400 differs from stent-graft system 200 in that stent-graft system 400 does not include a separate sealing component (e.g., sealing component 240). Instead, expandable filling structure 430 can provide a seal within proximal neck region 17 (beneath or distal to renal arteries 15 and 16). Because a separate sealing component is not provided, and the same component (e.g., expandable filling structure 430) provides both sealing and balloon management functions, stent graft system 400 is less complex and, therefore, easier and less expensive to manufacture.

[0089] Additionally, expandable filling structure 432 is secured, bonded, attached, or otherwise coupled to the outer surface of branch stent-graft 214a. Expandable filling structure 434 is secured, bonded, attached, or otherwise coupled to the outer surface of branch stent-graft 214b. Each expandable filling structure 432 and 434 can be expanded using a dedicated fill line or a fill line shared with another component of stent-graft system 400. When expanded, expandable filling structures 432 and 434 radially expand from branch stent-grafts 214a and 214b toward the surface / wall of the sac of aneurysm 14. In the expanded state, expandable filling structures 432 and 434 surround branch stent-grafts 214a and 214b, respectively. As shown, expandable filling structure 430 expands and fills the upper or proximal portion of the sac of aneurysm 14, while expandable filling structures 432 and 434 expand and fill the lower or distal portion of the sac. The entire volume of the bladder is therefore filled by the combination of expandable filling structures 430 , 432 , and 434 .

[0090] In some examples, expandable filling structure 432 is fixed, bonded, attached, or otherwise coupled to a portion (but not all) of the outer surface of branch stent-graft 214a. Expandable filling structure 432 (when expanded) surrounds a portion (but not all) of the outer surface of branch stent-graft 214a. For example, as shown, expandable filling structure 432 (in the expanded state) surrounds a middle portion of branch stent-graft 214a, wherein the middle portion is between the proximal end (the portion located within docking region 250 when deployed) and the distal end (the portion located within iliac artery 12 when deployed) of branch stent-graft 214a. Thus, expandable filling structure 432 is not fixed, bonded, attached, or otherwise coupled to and does not surround the portion of branch stent-graft 214a inserted into docking region 250 and the portion of branch stent-graft 214a placed in iliac artery 12. With respect to branch stent-graft 214b, expandable filling structure 434 is similar to expandable filling structure 432.

[0091] In some examples, expandable filling structures 432 and 434 do not expand into the lumen of proximal graft 212 in docking region 250 to seal groove 302. If expandable filling structures 432 and 434 were to expand into the lumen of proximal graft 212, then, while expandable filling structures 432 and 434 are expanding, branch stent-grafts 214a and 214b (after docking) would migrate distally downward toward aortic bifurcation 11 and out of proximal graft 212. After branch stent-grafts 214a and 214b are deployed within proximal graft 212, groove 302 (located within the lumen of proximal graft 212) can be closed / sealed by expanded expandable filling structure 430. In other words, expandable filling structure 430 (in its expanded state) fills and seals groove 302 located within the lumen of proximal graft 212. In this manner, when the proximal graft catheter is removed, the proximal graft filling lumen remains connected to allow the ipsi branch stent grafts 214a and 214b to be deployed. In some arrangements, when the branch stent grafts 214a and 214b are docked within the proximal graft 212, the portion of the proximal graft 212 located within the docking region 250 is unsupported graft (e.g., PTFE without a stent) to conform around the branch stent grafts 214a and 214b.

[0092] Figure 5 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 500. Figure 1 、 Figure 2 and Figure 4A-4B and Figure 5 , stent-graft system 500 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, expandable filling structure 430, expandable filling structures 532 and 534, and anchor 245 (not shown for clarity). Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, expandable filling structure 430, and anchor 245 are components of stent-graft system 400 that are similar to corresponding components of stent-graft systems 200 and 400 and incorporate similar improvements. Additionally, when deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can dock within proximal graft 212 (e.g., within docking region 250) in the manner described.

[0093] In some examples, expandable filling structure 532 is secured, bonded, attached, or otherwise coupled to the entire outer surface of branch stent-graft 214a. Expandable filling structure 534 is secured, bonded, attached, or otherwise coupled to the entire outer surface of branch stent-graft 214b. Thus, expandable filling structures 532 and 534 are secured, bonded, attached, or otherwise coupled to and (in the expanded state) surround the mid-portion and the portions of branch stent-grafts 214a and 214b inserted into docking region 250 and the portions of branch stent-grafts 214a and 214b placed in iliac arteries 12.

[0094] Each expandable filling structure 532 and 534 can be expanded using a dedicated fill line or a fill line shared with another component of stent-graft system 500. When expanded, expandable filling structures 532 and 534 radially expand from branch stent-grafts 214a and 214b toward the surface / wall of the sac of aneurysm 14. In the expanded state, expandable filling structures 532 and 534 surround the entire outer surface of branch stent-grafts 214a and 214b, respectively. As shown, expandable filling structure 430 expands and fills the upper or proximal portion of the sac of aneurysm 14, while expandable filling structures 532 and 534 expand and fill the lower or distal portion of the sac. Thus, the entire volume of the sac is filled by the combination of expandable filling structures 430, 532, and 534.

[0095] In some examples, expandable filling structures 532 and 534 expand into the lumen of proximal graft 212 located in docking region 250 to seal the groove in docking region 250. In such an arrangement, expandable filling structure 430 can be filled in the manner described, and the delivery system for proximal graft 212 and expandable filling structure 430 can be removed before deploying branch stent-grafts 214a and 214b and expanding expandable filling structures 532 and 534, thereby completing the deployment operation.

[0096] Figure 6A is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 600. Figure 6B is deployed in the aneurysm 14 ( Figure 1 ) on an example stent graft system 600 ( Figure 6A ) another cross-sectional view. Figure 1 、 Figure 2 and Figure 6A-Figure 6B, stent-graft system 600 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, expandable filling structure 630, and anchor 245. Proximal graft 212, first branch stent-graft 214a, second branch 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 provide similar improvements. Additionally, when deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can be docked in proximal graft 212 (e.g., in docking region 250) in the manner described. As shown, Figure 6B is a cross-sectional view of a stent graft system 600, which is shown in FIG. Figure 6A The docking area 250 is shown cut away.

[0097] Expandable filling structure 630 is fixed, bonded, attached, or otherwise coupled to the outer surface of proximal graft 212. In some examples, expandable filling structure 630 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of proximal graft 212, except for a portion of the outer surface of proximal graft 212 adjacent to the edge of the proximal end of proximal graft 212. In other examples, expandable filling structure 630 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of proximal graft 212. In some examples, in the expanded state, expandable filling structure 630 surrounds the outer surface of proximal graft 212 (when deployed in aorta 10), including the portion of proximal graft 212 located in proximal neck region 17 and in the sac of aneurysm 14. Thus, stent-graft system 600 differs from stent-graft system 200 in that stent-graft system 600 does not include a separate sealing component (e.g., sealing component 240). Alternatively, the expandable filling structure 630 may provide a seal within the proximal neck region 17 (beneath or distal to the renal arteries 15 and 16 ).

[0098] In addition, the expandable filling structure 630 is configured to seal the groove 302. The expandable filling structure 630 is configured to extend into the sac of the aneurysm 14 and surround each of the branch stent-grafts 214a and 214b (including portions of the branch stent-grafts 214a and 214b located outside the docking region 250) when deployed. After the branch stent-grafts 214a and 214b are docked within the single lumen of the proximal graft 212, the expandable filling structure 630 is filled via the fill line 601. As shown, when filled to an 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 branch stent-grafts 214a and 214b while radially pushing against the surface / wall of the sac of the aneurysm 14. Branch stent-grafts 214a and 214b do not have any expandable filling structure fixed, bonded, attached, or otherwise coupled thereto. Thus, expandable filling structure 630 can (by surrounding branch stent-grafts 214a and 214b) close groove 302 and fill the aneurysm sac from proximal neck region 17 to aortic bifurcation 11. In some examples (not shown), expandable filling structure 630 can even extend into iliac arteries 12 and 13 while surrounding the portions of branch stent-grafts 214a and 214b located within iliac arteries 12 and 13.

[0099] Thus, to seal the entire sac of aneurysm 14 (including groove 302, proximal neck region 17, and sometimes even iliac arteries 12 and 13), only one component (expandable filling structure 630) is required, and only one filling line (fill line 601) and only one filling operation are required to perform both the sealing function and the sac management function, thereby achieving shorter procedure time. Since branch stent-grafts 214a and 214b do not have any expandable filling structures, the complexity and cost of stent-graft system 600 are also lower.

[0100] Figure 7 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 700. Figure 1 、 Figure 2 and Figure 7, stent-graft system 700 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing member 240, anchor 245, and support member 702. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing member 240, and anchor 245 are components of stent-graft system 700 that are similar to, and offer similar improvements to, corresponding components of stent-graft system 200. Furthermore, when deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can dock within proximal graft 212 (e.g., within docking region 250) in the manner described.

[0101] The unsupported section 704 of the proximal graft 212 comprises a graft material (e.g., PTFE) without a scaffold for structural support. The unsupported section 704 is configured for proximal extension. That is, when the proximal graft 212 is deployed within the aorta 10 in the manner described, the unsupported section 704 extends into the proximal neck region 17. The sealing member 240 is attached, fixed, or otherwise coupled to the outer surface of the unsupported section 704 of the proximal graft 212.

[0102] In some arrangements, the support member 702 is a support ring or balloon made of a polymer (e.g., PTFE, polyurethane, etc.). The support member 702 surrounds the portion of the proximal graft 212 located in the docking region 250. In other words, the support member 702 is attached, fixed, bonded (e.g., heat bonded), sutured, or otherwise coupled to the proximal graft 212, such as to the outer surface of the proximal graft 212. In some examples, the portion of the proximal graft 212 located in the docking region 250 is unsupported. In some examples, the entire proximal graft 212 (including the docking region 250 and the unsupported section 704) is unsupported. The support member 702 can facilitate cannulation of the proximal graft 212 before or during filling of the proximal graft 212 with an expandable filling structure (not shown) via a suitable filling line. Such an expandable filling structure can be fixed, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212. In some examples, in the expanded state, such an expandable filling structure surrounds the outer surface of the proximal graft 212 (when deployed in the aorta 10), including one or more of the following: a portion of the proximal graft 212 located in the proximal neck region 17, a portion of the proximal graft 212 located in the sac of the aneurysm 14, a groove, etc. The support member 702 can be a supporting expandable filling structure that expands before or during expansion to provide structural integrity to the unsupported portion of the proximal graft 212 (e.g., the portion located in the docking region 250). In the expanded state, the support member 702 provides structural integrity by preventing collapse of the proximal graft 212. In some examples, the support member 702 can be integrally formed with the delivery system used to deliver the proximal graft 212. That is, the support member 702 can be filled using the same catheter (a common fill line) used to fill the proximal graft 212. Alternatively, support member 702 may be filled using a catheter separate from the catheter of the delivery system used for proximal implant 212. Support member 702 does not increase the profile of the device.

[0103] Figure 8 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 800. Figure 1 、 Figure 2 、 Figure 7 and Figure 8, stent-graft system 800 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing component 240, and anchor 245. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing component 240, and anchor 245 are components of stent-graft system 800 that are similar to corresponding components of stent-graft system 200 and incorporate similar improvements. Furthermore, when deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can be docked within proximal graft 212 (e.g., within docking region 250) in the manner described. As described, unsupported section 704 of proximal graft 212 comprises a graft material (e.g., PTFE) without a stent for structural support. In some examples, other portions of proximal graft 212, in addition to unsupported section 704, can also be unsupported. In some examples, the entirety of proximal implant 212 is unsupported. Sealing member 240 is attached, secured, or otherwise coupled to an outer surface of unsupported section 704 of proximal implant 212.

[0104] In some arrangements, the proximal graft 212 includes a wire stent component 802 embedded therein. In some examples, the wire stent component 802 comprises a wire stent (having multiple wire loops) and does not have any graft material coupled thereto, such that the lumen of the proximal graft 212 is open at the wire stent component 802 for ease of cannulation. In other examples, the wire stent component 802 has graft material coupled thereto. In some examples, the wire stent component 802 is located at the distal end of the proximal graft 212. In some examples, the wire stent component 802 is located in the docking region 250 of the proximal graft 212.

[0105] The wire-wound stent component 802 can facilitate cannulation of the proximal graft 212 before or during filling of the proximal graft 212 with an expandable filling structure (not shown) via a suitable filling line. Such an expandable filling structure can be fixed, bonded, attached, or otherwise coupled to the outer surface of the proximal graft 212. In some examples, in the expanded state, such an expandable filling structure surrounds the outer surface of the proximal graft 212 (when deployed in the aorta 10), including one or more of the following: a portion of the proximal graft 212 located in the proximal neck region 17, a portion of the proximal graft 212 located in the sac of the aneurysm 14, a groove, etc. Before or during expansion of the expandable filling structure, the wire-wound stent component 802 can provide structural integrity to the proximal graft 212. The wire-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 in angled anatomical structures. The coiled stent component 802 can provide improved mechanical lock between the proximal graft 212 and the branch stent grafts 214a and 214b in the docking region 250 by providing sufficient radial force to minimize the possibility of displacement between the proximal graft 212 and the branch stent grafts 214a and 214b, thereby increasing coaptation disengagement resistance and minimizing Type III endoleaks.

[0106] Figure 9 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 900. Figure 1 、 Figure 2 and Figure 7-Figure 9 , stent-graft system 900 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing component 240, and anchor 245. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing component 240, and anchor 245 are components of stent-graft system 900 that are similar to corresponding components of stent-graft system 200 and incorporate similar improvements. Furthermore, when deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can be docked within proximal graft 212 (e.g., within docking region 250) in the manner described. As described, unsupported section 704 of proximal graft 212 comprises a graft material (e.g., PTFE) without a stent for structural support. In some examples, other portions of proximal graft 212, in addition to unsupported section 704, can also be unsupported. In some examples, the entirety of proximal implant 212 is unsupported. Sealing member 240 is attached, secured, or otherwise coupled to an outer surface of unsupported section 704 of proximal implant 212.

[0107] In some arrangements, the proximal graft 212 includes a wire stent ring 902 embedded therein. In some examples, the wire stent ring 902 comprises a single ring of wire stent and does not have any graft material coupled thereto, such that the lumen of the proximal graft 212 is open at the wire stent component 902 for ease of cannulation. In other examples, the wire stent ring 902 has graft material coupled thereto. In some examples, the wire stent ring 902 is located at the distal end of the proximal graft 212 and adjacent to the edge of the proximal graft 212. In some examples, the wire stent ring 902 is located in the docking region 250 of the proximal graft 212.

[0108] The wire stent ring 902 can facilitate cannulation of the proximal graft 212 before or during filling of the proximal graft 212 with an expandable filling structure (not shown) via a suitable filling line. Such an expandable filling structure can be fixed, 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 (when deployed in the aorta 10), including one or more of the following: a portion of the proximal graft 212 located in the proximal neck region 17, a portion of the proximal graft 212 located in the sac of the aneurysm 14, a groove, etc. Before or during expansion of the expandable filling structure, the wire stent ring 902 can provide structural integrity to the proximal graft 212. The wire 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 in angled anatomical structures. The coiled stent ring 902 can provide improved mechanical lock between the proximal graft 212 and the branch stent grafts 214a and 214b in the docking region 250 by providing sufficient radial force to minimize the possibility of displacement between the proximal graft 212 and the branch stent grafts 214a and 214b, thereby increasing coaptation disengagement resistance and minimizing Type III endoleak.

[0109] Figure 10 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1000. Figure 1 、 Figure 2 and Figure 10, stent-graft system 1000 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing member 1240, anchor 245, expandable filling structure 1002, and expandable filling structure 1004. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, and anchor 245 are components of stent-graft system 1000 that are similar to, and incorporate similar improvements to, corresponding components of stent-graft system 200. In some arrangements, sealing member 1240 is similar to sealing member 240, except that sealing member 1240 is wider so that a portion of sealing member 1240 extends outside of proximal neck region 17 and into the sac of aneurysm 14. When deployed in the aorta 10, the first branch stent-graft 214a and the second branch stent-graft 214b can dock in the proximal graft 212 (e.g., in the docking region 250) in the manner described. In some examples, the portion of the proximal graft 212 located in the docking region 250 includes a wire-wound stent ring 902. In some examples, the wire-wound stent ring 902 comprises a single ring of wire-wound stent and does not have any graft material coupled thereto, such that the lumen of the proximal graft 212 is open at the wire-wound stent component 902 for ease of cannulation.

[0110] In some arrangements, each branch stent-graft 214a and 214b includes a respective one of the wire-wound stent components 1012 and 1014 embedded therein. In some examples, each wire-wound stent component 1012 and 1014 includes a wire-wound stent (having multiple wire loops) and does not have any graft material coupled thereto, such that the lumen of each branch stent-graft 214a and 214b is open at the respective one of the wire-wound stent components 1012 and 1014 to facilitate cannulation. In other examples, the wire-wound stent components 1012 and 1014 have graft material coupled thereto. In some examples, each wire-wound stent component 1012 and 1014 is located at the distal end of the respective one of the branch stent-grafts 214a and 214b and is positioned in the iliac arteries 12 and 13 upon deployment.

[0111] Expandable filling structure 1002 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of branch stent-graft 214a. Expandable filling structure 1004 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of branch stent-graft 214b. Each expandable filling structure 1002 and 1004 can be expanded using a dedicated fill line or using a fill line shared with another component of stent-graft system 1000. When expanded, expandable filling structures 1002 and 1004 radially expand from branch stent-grafts 214a and 214b toward the surface / wall of the sac of aneurysm 14. In the expanded state, expandable filling structures 1002 and 1004 surround branch stent-grafts 214a and 214b, respectively.

[0112] In some examples, expandable filling structure 1002 is fixed, bonded, attached, or otherwise coupled to a portion (but not all) of the outer surface of branch stent-graft 214a. Expandable filling structure 1002 (when expanded) surrounds a portion (but not all) of the outer surface of branch stent-graft 214a. In some arrangements, expandable filling structure 1002 is not fixed, bonded, attached, or otherwise coupled to and does not surround the portion of branch stent-graft 214a that is placed in iliac artery 12 when deployed or the portion of branch stent-graft 214a that corresponds to coiled stent components 1012 and 1014. In other arrangements, expandable filling structure 1002 is fixed, bonded, attached, or otherwise coupled to and surrounds the portion of branch stent-graft 214a that is placed in iliac artery 12 when deployed or the portion of branch stent-graft 214a that corresponds to coiled stent components 1012 and 1014. With respect to branch 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, bonded, attached, or otherwise coupled to and do not surround the portion of a respective one of branch stent-grafts 214a and 214b that is inserted into docking region 250. In some examples, expandable filling structures 1002 and 1004 surround stent-grafts 214a and 214b outside of docking region 250 to seal the groove, where the docking region contacts the edge of the distal end of proximal graft 212. In some examples, expandable filling structures 1002 and 1004 expand into the lumen of proximal graft 212 located in docking region 250 to seal the groove.

[0113] Furthermore, expandable filling structures 1002 and 1004 are configured to extend into the sac of aneurysm 14 and surround the portion of proximal graft 212 located within the sac when deployed. As shown, when filled to an expanded state, expandable filling structures 1002 and 1004 can extend in a proximal direction toward proximal neck region 17 to surround proximal graft 212 while radially pushing against the surface / wall of the sac of aneurysm 14. Proximal graft 212 does not have any expandable filling structures fixed, bonded, attached, or otherwise coupled thereto. Since no expandable filling structures are provided for the stent graft, stent graft system 1000 is less expensive to manufacture. As shown, the entire volume of the sac is thus filled with expandable filling structures 1002 and 1004.

[0114] In some examples, instead of two expandable filling structures 1002 and 1004, a single expandable filling structure may be used (which is secured, bonded, attached, or otherwise coupled to either or both of the branch stent-grafts 214a and 214b) to surround the branch stent-grafts 214a and 214b and extend into the sac of the aneurysm 14 and to surround the portion of the proximal graft 212 that is located within the sac when deployed.

[0115] Figure 11A is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1100. Figure 11B is deployed in the aneurysm 14 ( Figure 1 ) on an example stent graft system 1100 ( Figure 11A ) another cross-sectional view. Figure 1 、 Figure 2 and Figure 10-11B, stent-graft system 1100 includes proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, sealing member 240, anchor 245, and expandable filling structures 1002 and 1004. Proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, sealing member 240, and anchor 245 are components of stent-graft system 1100 that are similar to corresponding components of stent-graft system 200 and have similar improvements. Additionally, expandable filling structures 1002 and 1004 are components of stent-graft system 1100 that are similar to corresponding components of stent-graft system 1000 and have similar improvements. Stent-graft system 1100 differs from stent-graft system 1000 in that proximal graft 212 of stent-graft system 1100 does not include coiled stent component 902, and tributary stent-grafts 214a and 214b of stent-graft system 1100 do not include coiled stent components 1012 and 1014. As described, unsupported section 704 of proximal graft 212 has graft material (e.g., PTFE) without a stent for structural support.

[0116] As described, 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 branch stent-grafts 214a and 214b. In examples where expandable filling structures 1002 and 1004 are not fixed, bonded, attached, or otherwise coupled to and surround the portion of a respective one of branch stent-grafts 214a and 214b inserted into docking region 250, expandable filling structures 1002 and 1004 are configured to extend into the sac of aneurysm 14 and surround the portion of proximal graft 212 located within the sac when deployed. In other arrangements, expandable filling structures 1002 and 1004 are fixed, bonded, attached, or otherwise coupled to and surround the portion of a respective one of branch stent-grafts 214a and 214b inserted into docking region 250. In such an arrangement, each expandable filling structure 1002 and 1004 can expand within the lumen of the proximal implant 212 to seal the groove 302 when inflated via a dedicated or shared fill line.

[0117] Figure 12 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1200. Figure 1 、 Figure 2 and Figure 12, stent-graft system 1200 includes proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, sealing component 240, anchor 245, and expandable filling structures 1202, 1204, and 1230. 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 1200 that are similar to corresponding components of stent-graft system 200 and incorporate similar improvements.

[0118] In some examples, the shape and compliance (elasticity) of expandable filling structure 1230 allows expandable filling structure 1230 to form a funnel within the sac of aneurysm 14 when expanded. For example, expandable filling structure 1230 is similar to expandable filling structure 230, except that expandable filling structure 1230, when filled, expands radially toward the surface / wall of the sac of aneurysm 14 and also expands in a distal direction toward iliac arteries 12 and 13, such that a portion of expandable filling structure 1230 abutting or adjacent to the surface / wall of the sac of aneurysm 14 extends further in the distal direction (e.g., along the surface / wall of the sac of aneurysm 14) than a portion of expandable filling structure 1230 abutting or adjacent to proximal graft 212, thereby creating a funnel shape. Expandable filling structure 1230 is made of a material that is sufficiently soft and elastic to allow expandable filling structure 1230 to form the funnel shape.

[0119] The funnel shape is used to facilitate cannulation. In one example, proximal graft 212 can be deployed within aorta 10 in the manner described. Expandable filling structure 1230 can be expanded to form the funnel shape. Branch stent-grafts 214a and 214b can be inserted into the lumen of proximal graft 212 guided by the funnel shape of expandable filling structure 1230. That is, as branch stent-grafts 214a and 214b are moved proximally toward proximal neck region 17, the inclined surface of expandable filling structure 1230 can guide the proximal ends of branch stent-grafts 214a and 214b into the lumen of proximal graft 212. In another example, branch stent-grafts 214a and 214b can be deployed within aorta 10 in the manner described. When proximal graft 212 is inserted into aorta 10, expandable filling structure 1230 can be expanded to form the funnel shape. The inclined surface of expandable filling structure 1230 can guide proximal graft 212 so that when proximal graft 212 moves in the distal direction, branch stent-grafts 214a and 214b can be inserted into the lumen of proximal graft 212. In some examples, the stent-graft delivery system uses an integrated contra wire to replace the retrograde cannula into the large hole of proximal graft 212.

[0120] In some examples, sealing member 240 can be made of a less compliant material (e.g., polyester, PTFE, polyurethane, etc.) than the material (e.g., PTFE, low durometer polyurethane, etc.) from which expandable filling structure 1230 is made. A less compliant sealing member 240 (approximately 1 cm wide) can provide a tighter seal in proximal neck region 17.

[0121] Expandable filling structure 1202 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of branch stent-graft 214a (including the portion of branch stent-graft 214a positioned in iliac artery 12 and in docking region 250) when deployed. Expandable filling structure 1204 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of branch stent-graft 214b (including the portion of branch stent-graft 214b positioned in iliac artery 13 and in docking region 250). Each expandable filling structure 1202 and 1204 can be expanded using a dedicated fill line or using a fill line shared with another component of stent-graft system 1200. When expanded, expandable filling structures 1202 and 1204 radially expand from branch stent-grafts 214a and 214b toward the surface / wall of the sac of aneurysm 14. As such, the entire volume of the sac is filled by the combination of expandable filling structures 1202, 1204, and 1230. In the expanded state, expandable filling structures 1202 and 1204 surround branch stent grafts 214a and 214b, respectively. Expandable filling structures 1202 and 1204 can also expand within the lumen of proximal graft 212 to seal any grooves therein. Furthermore, when branch stent grafts 214a and 214b are deployed, expandable filling structures 1202 and 1204 can expand within iliac arteries 12 and 13 to form a seal therein.

[0122] Figure 13A is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1300. Figure 13B is deployed in the aneurysm 14 ( Figure 1 ) on an example stent graft system 1300 ( Figure 13A ) another cross-sectional view. Figure 1 、 Figure 2 、 Figure 13A and Figure 13B, stent-graft system 1300 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing member 240, anchor 245, and at least one support member (e.g., support members 1302 and 1304). Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing member 240, and anchor 245 are components of stent-graft system 1300 that are similar to corresponding components of stent-graft system 200 and provide similar improvements. Additionally, when deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can dock within proximal graft 212 (e.g., within docking region 250) in the manner described.

[0123] To seal any grooves that may form in the lumen of proximal graft 212 when tributary stent grafts 214a and 214b are inserted into the lumen of proximal graft 212, at least one support member (e.g., support members 1302 and 1304) is embedded in proximal graft 212. In some arrangements, support members 1302 and 1304 are support expandable filling structures, such as, but not limited to, support rings or balloons made of polymers (e.g., PTFE, polyurethane, etc.). Support members 1302 and 1304 are embedded in the portion of proximal graft 212 located in docking region 250. Support members 1302 and 1304 are attached, secured, bonded (e.g., heat bonded), sewn, or otherwise coupled to proximal graft 212 such that an interior portion (including an interior surface portion) of each support member 1302 and 1304 is located within the lumen of proximal graft 212, while the remaining exterior portions (including exterior surface portions) of support members 1302 and 1304 are located outside the lumen of proximal graft 212. In some examples, the portion of proximal graft 212 located in docking region 250 is unsupported.

[0124] After proximal graft 212 is deployed in aorta 10 in the manner described, each strut member 1302 and 1304 can be inflated using a dedicated fill line or using a fill line shared with another component of stent-graft system 1300. In some examples, each strut member 1302 and 1304 can be pre-shaped using a bivalve balloon on a catheter used to deploy proximal graft 212, wherein the strut members 1302 and 1304 are inflated around the bivalve balloon on the catheter. Thus, in the inflated state, each strut member 1302 and 1304 forms an opening 1306 (corresponding to the shape of the bivalve balloon on the catheter) through which branch stent-grafts 214a and 214b can be inserted. Opening 1306 presents a bivalve opening. Since support members 1302 and 1304 are elastic and opening 1306 is slightly smaller than the sum of the cross-sectional areas of the proximal ends of branch stent grafts 214a and 214b, support members 1302 and 1304 form a tight seal around branch stent grafts 214a and 214b when inserted. Although two support members 1302 and 1304 are shown, one or three or more support members (such as, but not limited to, support members 1302 and 1304) may be implemented.

[0125] The implementation of support members 1302 and 1304 allows stent graft system 1300 to seal the groove without requiring an expandable filling structure (such as an endobag). If a Type II endoleak is not present, the physician may select stent graft system 1300, since it is preferable not to fill the entire sac of aneurysm 14 with a polymer (e.g., an endobag).

[0126] Figure 14 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1400. Figure 1 、 Figure 2 and Figure 14, stent-graft system 1400 includes proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, sealing components 1402 and 1440, anchor 245, and at least one internal support component (e.g., internal support component 1404). Proximal graft 212, first limb stent-graft 214a, second limb stent-graft 214b, and anchor 245 are components of stent-graft system 1400 that are similar to corresponding components of stent-graft system 200 and provide similar improvements. In some examples, anchor 245 of stent-graft system 1400 can be fixed or attached to the proximal end of proximal graft 212 or to sealing component 1440. Sealing component 1440 is similar to sealing component 240, except that in some arrangements, sealing component 1440 is narrower than sealing component 240. Additionally, when deployed in the aorta 10, the first branch stent graft 214a and the second branch stent graft 214b can be docked in the proximal graft 212 (e.g., in the docking region 250) in the manner described. As shown, a portion of the docking region 250 is located in the proximal neck region 17, while the remainder of the docking region 250 is located in the sac of the aneurysm 14. The proximal graft 212 is shown having a wire-wound stent (having a plurality of wire-wound loops) in addition to the graft material (e.g., Figure 14 The proximal graft 212 in the embodiment is a stent graft).

[0127] In some examples, sealing member 1402 is coupled to the distal end of proximal graft 212 to seal the groove formed when tributary stent grafts 214a and 214b are inserted into the lumen of proximal graft 212 in docking region 250. Sealing member 1402 can be an expandable filling structure made of a polymer (e.g., PTFE, polyurethane, etc.) that can be expanded using a dedicated fill line or using a shared fill line shared with another component of stent graft system 1400. In the expanded state, sealing member 1402 can have a single bivalve opening or two openings to receive the proximal ends of tributary stent grafts 214a and 214b. Due to the elasticity of the material of sealing member 1402, sealing member 1402 forms a seal around tributary stent grafts 214a and 214b at the lumen opening of proximal graft 212.

[0128] To provide an additional sealing feature to seal the groove (which may be formed when the limb stent grafts 214a and 214b are inserted into the lumen of the proximal graft 212), an internal support member 1404 is embedded in the proximal graft 212. In some arrangements, the internal support member 1404 is a supporting expandable filling structure, such as, but not limited to, an inner bag made of a polymer (e.g., PTFE, polyurethane, etc.). The internal support member 1404 is embedded in the portion of the proximal graft 212 located in the docking region 250. The internal support member 1404 is attached, fixed, bonded (e.g., heat bonded), sutured, or otherwise coupled to the inner surface of the proximal graft 212. The inner surface of the proximal graft 212 faces the lumen of the proximal graft 212. The internal support member 1404 expands within the lumen of the proximal graft 212 when filled.

[0129] After proximal graft 212 is deployed in aorta 10 in the manner described, branch stent-grafts 214a and 214b are inserted into the lumen of proximal graft 212. After branch stent-grafts 214a and 214b are inserted, inner support member 1404 can be expanded using a dedicated fill line or using a common fill line shared with another component of stent-graft system 1400. In the expanded state, inner support member 1404 forms a seal around the proximal ends of branch stent-grafts 214a and 214b (including the space between branch stent-grafts 214a and 214b and the space between the inner surface of proximal graft 212 and each of branch stent-grafts 214a and 214b, as shown). Since inner support member 1404 is elastic (e.g., more compliant than polymer support rings such as support members 1302 and 1304) and inner support member 1404 expands inwardly within the lumen of proximal graft 212, inner support member 1404 can form a tight seal around branch stent grafts 214a and 214b when inserted. Although one inner support member 1404 is shown, two or more inner support members (such as, but not limited to, inner support member 1404) can be implemented.

[0130] Figure 15A is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1500. Figure 15B is deployed in the aneurysm 14 ( Figure 1 ) on an example stent graft system 1500 ( Figure 15A ) is another cross-sectional view. Figure 15C is deployed in the aneurysm 14 ( Figure 1 ) on an example stent graft system 1500 ( Figure 15A ) is another cross-sectional view. Figure 1 、 Figure 2 、 Figure 4A-4B and Figures 15A-15C , stent-graft system 1500 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, expandable filling structures 430, 432, and 434, anchor 245, and inner expandable filling structure 1502. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, and anchor 245 are components of stent-graft system 1500 that are similar to, and incorporate similar improvements to, corresponding components of stent-graft system 200. When deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can dock within proximal graft 212 (e.g., within docking region 250) in the manner described.

[0131] Additionally, expandable filling structures 430, 432, and 434 are components of stent-graft system 1500 that are similar to, and offer similar improvements to, corresponding components of stent-graft system 400, except that expandable filling structure 430 (in the expanded state) does not fill or seal the grooves within the lumen of proximal graft 212. Instead, inner expandable filling structure 1502 may expand to seal the grooves.

[0132] For example, to seal the groove (which may be formed in the lumen of the proximal graft 212 when the first and second branch stent grafts 214a, 214b are inserted into the lumen of the proximal graft 212), an internal expandable filling structure 1502 is embedded in the proximal graft 212. In some arrangements, the internal expandable filling structure 1502 is a supporting expandable filling structure, such as, but not limited to, an inner bag made of a polymer (e.g., PTFE, polyurethane, etc.). The internal expandable filling structure 1502 is attached, fixed, bonded (e.g., heat bonded), sutured, or otherwise coupled to the entire inner surface of the proximal graft 212. The inner surface of the proximal graft 212 faces the lumen of the proximal graft 212. When filled, the internal expandable filling structure 1502 expands within the lumen of the proximal graft 212.

[0133] In some examples, in the expanded state, the inner expandable filling structure 1502 includes: a proximal portion (having a cross-section in Figure 15B ), corresponding to the proximal end of the proximal implant 212; and the distal portion (whose cross-section is in Figure 15C), corresponding to the distal end of the proximal graft 212. The distal portion of the inner expandable filling structure 1502 corresponds to the docking region 250. When filled, the proximal portion of the inner expandable filling structure 1502 forms a single lumen, while the distal portion of the inner expandable filling structure 1502 forms a bivalve lumen. The inner expandable filling structure 1502 can be pre-shaped by the catheter used to deploy the proximal graft 212. For example, when the proximal graft 212 is deployed in the aorta 10 in the manner described, the proximal portion of the inner expandable filling structure 1502 is expanded around the balloon of the catheter having a circular or elliptical cross-section, while the distal portion of the inner expandable filling structure 1502 is expanded around the bivalve balloon of the catheter. In this way, the inner expandable filling structure 1502 forms a bifurcated lumen within the lumen of the proximal graft 212. Before tributary stent-grafts 214a and 214b are inserted, inner expandable filling structure 1502 may be inflated using a dedicated fill line or using a common fill line shared with another component of stent-graft system 1500 .

[0134] In the expanded state, the distal portion of inner expandable filling structure 1502 forms a seal around the proximal ends of branch stent-grafts 214a and 214b (including the space between branch stent-grafts 214a and 214b and the space between the inner surface of proximal graft 212 and each of branch stent-grafts 214a and 214b, as shown). Because inner expandable filling structure 1502 is elastic and inner support member 1404 expands inwardly within the lumen of proximal graft 212, inner expandable filling structure 1502 can form a tight seal around branch stent-grafts 214a and 214b when inserted.

[0135] Figure 16 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1600. Figure 1 、 Figure 2 and Figure 16Stent-graft system 1600 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing component 240, expandable filling structure 1630, and anchor 1645. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, and sealing component 240 are components of stent-graft system 1600 that are similar to corresponding components of stent-graft system 200 and incorporate similar improvements. Anchor 1645 is similar to anchor 245, except that anchor 1645 comprises a wire-wound stent having multiple wire-wound loops. Anchor 1645 comprises hooks or barbs on the wire-wound stent that anchor, secure, or attach to a wall / surface of aorta 10 proximal to the renal ostium and proximal neck region 17. When deployed in aorta 10, first and second branch stent grafts 214a, 214b can dock in the described manner within proximal graft 212 (e.g., within docking region 250). In some examples, branch stent grafts 214a and 214b are shown as comprising wire-wound stents having multiple wire-wound loops.

[0136] Expandable filling structure 1630 is secured, bonded, attached, or otherwise coupled to the outer surface of proximal graft 212. In some examples, expandable filling structure 1630 is secured, bonded, attached, or otherwise coupled to the entire outer surface of proximal graft 212, except for a portion of the outer surface of proximal graft 212 that is adjacent to the edge of the proximal end of proximal graft 212. In other examples, expandable filling structure 1630 is secured, bonded, attached, or otherwise coupled to the entire outer surface of proximal graft 212.

[0137] Expandable filling structure 1630 is a bifurcated expandable filling structure or endobag such that, in an expanded state, expandable filling structure 1630 surrounds the outer surface of proximal graft 212 (when deployed in aorta 10) while providing two lumens for receiving branch stent grafts 214a and 214b. Expandable filling structure 1630 can be pre-shaped by the catheter used to deploy proximal graft 212. For example, when proximal graft 212 is deployed in aorta 10 in the manner described, expandable filling structure 1630 is inflated around the bifurcated balloon of the catheter to shape the lumens for receiving branch stent grafts 214a and 214b while expandable filling structure 1630 radially expands toward the surface / wall of the sac of aneurysm 14 to fill the entire sac, excluding the lumen of proximal graft 212 and the bifurcated balloon. Prior to inserting branch stent-grafts 214a and 214b, expandable filling structure 1630 can be inflated using a dedicated filling line or a common filling line shared with another component of stent-graft system 1600. Branch stent-grafts 214a and 214b can then be inserted into the lumen of expandable filling structure 1630 and the lumen of proximal graft 212. The lumen of expandable filling structure 1630 opens into and communicates with the lumen of proximal graft 212. Expandable filling structure 1630 can surround branch stent-grafts 214a and 214b and provide a tight seal, including in the area around docking region 250 to seal the groove. Because expandable filling structure 1630 can seal the groove while filling the entire sac, only one polymer filling step is required in stent-graft system 1600. Branch stent-grafts 214a and 214b also do not require any additional expandable filling structures coupled thereto, thereby reducing complexity and cost.

[0138] Figure 17 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1700. Figure 1 、 Figure 2 and Figure 17Stent-graft system 1700 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing component 1740, anchor 245, and expandable filling structures 1702, 1704, and 1730. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, and anchor are components of stent-graft system 1700 that are similar to corresponding components of stent-graft system 200 and incorporate similar improvements. As shown, each of stent-grafts 214a and 214b comprises a stent having multiple rings. In some examples, stent-grafts 214a and 214b comprise Nellix stents. When deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can dock within proximal graft 212 (e.g., within docking region 250) in the manner described.

[0139] 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 kinking and collapse of the lumen of the proximal graft 212 in angled anatomical structures and during polymer filling of the expandable filling structure 1730 (which may be soft). 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 achieving reduced cost and a reduced profile.

[0140] In some arrangements, sealing member 1740 is similar to sealing member 240, except that sealing member 1740 is narrower than sealing member 240. In some examples, sealing member 1740 can be made of a less compliant material (e.g., polyester, PTFE, polyurethane, etc.) than the material from which expandable filling structure 1730 is made (e.g., PTFE, low durometer polyurethane, etc.).

[0141] Compared to a soft inner bag, a less compliant and more rigid sealing member 1740 (approximately 1 cm wide) can provide a tighter seal and a more defined edge in the proximal neck region 17. A more defined edge at the proximal end of the proximal implant 212 can improve proximal placement accuracy.

[0142] Expandable filling structure 1730 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of proximal graft 212. In some examples, expandable filling structure 1730 is secured, bonded, attached, or otherwise coupled to the entire outer surface of proximal graft 212, except for the portion of the outer surface of proximal graft 212 coupled to sealing member 1740. In some examples, in the expanded state, expandable filling structure 1730 surrounds the outer surface of proximal graft 212 (when deployed in aorta 10), including portions of proximal graft 212 located in proximal neck region 17 and in the sac of aneurysm 14.

[0143] When deployed, expandable filling structure 1702 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of branch stent-graft 214a (including the portion of branch stent-graft 214a located in iliac artery 12 and in docking region 250). When deployed, expandable filling structure 1704 is fixed, bonded, attached, or otherwise coupled to the entire outer surface of branch stent-graft 214b (including the portion of branch stent-graft 214b located in iliac artery 13 and in docking region 250). Each expandable filling structure 1702 and 1704 can be inflated using a dedicated fill line or using a fill line shared with another component of stent-graft system 1700. When expanded, expandable filling structures 1702 and 1704 radially expand from branch stent-grafts 214a and 214b toward the surface / wall of the sac of aneurysm 14. As such, the entire volume of the sac is thus filled with the combination of expandable filling structures 1702, 1704, and 1730. Expandable filling structures 1702 and 1704 can expand within the lumen of proximal graft 212 to seal any grooves therein. Furthermore, when branch stent-grafts 214a and 214b are deployed, expandable filling structures 1702 and 1704 can expand within iliac arteries 12 and 13 to form a seal in iliac arteries 12 and 13.

[0144] Figure 18 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1800. Figure 1 、 Figure 2 and Figure 18, stent-graft system 1800 includes a laminated stent component 1812, a first branch stent-graft 214a, a second branch stent-graft 214b, a sealing component 1840, an anchor 1845, locking features 1852 and 1854, and an expandable filling structure 1830. First branch stent-graft 214a and second branch stent-graft 214b are components of stent-graft system 1800 that are similar to corresponding components of stent-graft system 200 and incorporate similar improvements. As shown, each stent-graft 214a and 214b comprises a stent having multiple rings. In some examples, stent-grafts 214a and 214b comprise Nellix stents. When deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can dock within laminated stent component 1812 (e.g., within docking region 250) in the manner described.

[0145] As shown, the laminated stent component 1812 includes components such as, but not limited to, a nickel titanium (NiTi) stent laminated with polytetrafluoroethylene. The laminated stent can be wire wound or laser cut. The laminated stent component prevents kinking and collapse of the lumen of the laminated stent component 1812 in angled anatomical structures and during polymer filling of the expandable filling structure 1830 (which can be soft). Providing a laminated stent component eliminates the need for a support balloon on the delivery system (which delivers the laminated stent component 1812 into the aorta 10), thereby resulting in reduced cost and a reduced profile. After the expandable filling structure 1830 is filled, the branch stent grafts 214a and 214b (which can be Nellix) are inserted into the laminated stent component 1812 in the docking area 250.

[0146] Expandable filling structure 1830 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of laminated stent component 1812. In some examples, expandable filling structure 1830 is secured, bonded, attached, or otherwise coupled to the entire outer surface of proximal graft 212, except for the portion of the outer surface of laminated stent component 1812 coupled to sealing component 1840. In some examples, in the expanded state, expandable filling structure 1830 surrounds the outer surface of laminated stent component 1812 (when deployed in aorta 10), including the portion of laminated stent component 1812 located in proximal neck region 17 and the portion located within the sac of aneurysm 14. In some arrangements, in the expanded state and when deployed, expandable filling structure 1830 surrounds or encapsulates the outer surface of the portion of sealing component 1840 located within the sac of aneurysm 14. In some examples, expandable filling structure 1830 extends in a distal direction toward aortic bifurcation 11 and iliac arteries 12 and 13 to fill the entire sac of aneurysm 14 .

[0147] In some examples, anchor 1845 can be a hook or barb on a stent of laminated stent component 1812. As shown, the hook or barb of anchor 1845 is located on the stent ring closest to renal arteries 15 and 16. The hook or barb of anchor 1845 can be located on another stent ring of laminated stent component 1812 as well as on more than one stent ring of laminated stent component 1812.

[0148] Sealing component 1840 can be an expandable sealing ring. In some embodiments, sealing component 1840 is coupled to laminated stent component 1812. For example, sealing component 1840 is attached, fixed, or otherwise coupled to the outer surface of the proximal end of laminated stent component 1812. In the expanded state, when laminated stent component 1812 is deployed, sealing component 1840 surrounds the portion of laminated stent component 1812 located in proximal neck region 17 and within the sac of aneurysm 14. In some examples, when sealing component 1840 is in the expanded state, sealing component 1840 does not contact and does not extend beyond the edge of the proximal end of laminated stent component 1812, such that the portion of laminated stent component 1812 adjacent to the edge of the proximal end of laminated stent component 1812 (e.g., the portion having anchor 1845) is not surrounded by sealing component 1840. Typically, devices with a sealing component of a certain width can be deployed within a range of neck lengths of the aortic neck region 17, meaning that a sealing component with an expanded width greater than the neck length cannot be deployed in the aortic neck region 17 of a subject having that neck length. On the other hand, the stent graft systems described herein (e.g., stent graft system 1800) can be deployed in the aorta 10 of a subject having a neck length shorter than that of other devices. This is because, if the neck length of the aortic neck region 17 is short, when there is no room for the sealing component 1840 to expand elsewhere in the aortic neck region 17, the sealing component 1840 is configured to extend into the sac of the aneurysm 14 (while the anchor 1845 is secured to the wall of the aortic neck region 17). The portion of the sealing component 1840 located within the sac of the aneurysm 14 can be used in conjunction with the expandable filling structure 1830 (e.g., the expandable filling structure 1830 encapsulates the portion of the sealing component 1840 located within the sac) for sac management.

[0149] Each locking feature 1852 and 1854 comprises a polymer sealing bag located on the proximal end of a respective one of the branch stent grafts 214a and 214b. In some arrangements, the polymer sealing bag is an expandable filling structure that, when deployed, is fixed, bonded, attached, or otherwise coupled to the outer surface of the respective one of the branch stent grafts 214a and 214b located in the docking region 250. The locking features 1852 and 1854 (when expanded) surround the outer surface of the proximal end of the respective one of the branch stent grafts 214a and 214b. In some arrangements, the locking features 1852 and 1854 are not fixed, bonded, attached, or otherwise coupled to and do not surround a portion of the respective one of the branch stent grafts 214a and 214b located outside the docking region 250 when deployed. When expanded, either through a dedicated fill line or through a shared fill line, when trunk stent-grafts 214 a and 214 b dock in docking region 250, locking features 1852 and 1854 radially expand from the proximal ends of trunk stent-grafts 214 a and 214 b toward the lumen of laminated stent component 1812 to seal the groove in docking region 250 between the inner surface of laminated stent component 1812 and the outer surfaces of trunk stent-grafts 214 a and 214 b.

[0150] Figure 19 is deployed in the aneurysm 14 ( Figure 1 ) is a cross-sectional view of an example stent graft system 1900. Figures 1-3B and Figure 19 Stent-graft system 1900 includes proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, expandable filling structure 330, sealing member 240, anchor 245, support structure 1920, and expandable structures 1932 and 1934. Proximal graft 212, first branch stent-graft 214a, second branch stent-graft 214b, sealing member 240, and anchor 245 are components of stent-graft system 1900 that are similar to corresponding components of stent-graft system 200 and have similar improvements. Expandable filling structure 330 is a component of stent-graft system 1900 that is similar to corresponding components of stent-graft system 300 and has similar improvements. When deployed in aorta 10, first branch stent-graft 214a and second branch stent-graft 214b can dock within proximal graft 212 (e.g., within docking region 250) in the manner described.

[0151] 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 in 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 resides within the lumen of proximal graft 212. When filled using a dedicated fill line or a shared fill line shared with another component of stent-graft system 1900, support structure 1920 expands within the lumen of proximal graft 212. Support structure 1920 prevents kinking and collapse of the lumen of proximal graft 212 in angled anatomies and during polymer filling of expandable filling structure 330 (which may be soft). The helical shape of support structure 1920 may also improve the anastomosis integrity of the abutting branch stent grafts 214a and 214b.

[0152] In some examples, expandable filling structure 1932 is fixed, bonded, attached, or otherwise coupled to the outer surface of the proximal end of branch stent-graft 214a. Expandable filling structure 1932 (when expanded) surrounds the outer surface of the proximal end of branch stent-graft 214a. In some arrangements, expandable filling structure 1002 is not fixed, bonded, attached, or otherwise coupled to and does not surround the portion of branch stent-graft 214a located outside of docking region 250. With respect to branch stent-graft 214b, expandable filling structure 1934 is similar to expandable filling structure 1932. When filling using a dedicated fill line or a common fill line shared with another component of stent-graft system 1900, when the proximal ends of branch stent-grafts 214a and 214b dock within the lumen of proximal graft 212 in docking region 250, expandable filling structures 1932 and 1934 expand from the lumen of proximal graft 212 in docking region 250 to seal the groove. Expandable filling structures 1932 and 1934 expand radially from the proximal ends of branch stent-grafts 214a and 214b toward the inner surface of proximal graft 212. As described, in the expanded state, expandable filling structure 330 can fill the sac of aneurysm 14.

[0153] Figure 20A 、 Figure 20B 、 Figure 20C 、 Figure 20D 、 Figure 20E 、 Figure 20F 、 Figure 20G 、 Figure 20H 、 Figure 20I 、 Figure 20J 、 Figure 20K and Figure 20LExamples of proximal implants 2000 according to various arrangements are shown. Figure 1 、 Figure 20A 、 Figure 20B 、 Figure 20C 、 Figure 20D 、 Figure 20E 、 Figure 20F 、 Figure 20G 、 Figure 20H 、 Figure 20I 、 Figure 20J 、 Figure 20K and Figure 20L The proximal graft 2000 is a graft component made of a 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 located in 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. Typically, the distal end of the proximal graft 2000 can be placed into the sac of the aneurysm 14. The proximal graft 2000 has a cylindrical shape and forms a hole 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 away from the lumen 2020 of the proximal graft 2000. Blood is configured to flow through cavity 2020 .

[0154] The proximal graft 2000 includes at least one support member. Each support member can be embedded in the proximal graft 2000. In some arrangements, the support members are supportive expandable filling structures surrounding the proximal graft 2000, such as, but not limited to, a support ring or balloon made of a polymer (e.g., PTFE, polyurethane, etc.). In some arrangements, the support members are attached, fixed, bonded (e.g., heat-bonded), sutured, or otherwise coupled to the proximal graft 2000 such that an inner portion (including an inner surface portion) of each support member is located within the cavity 2020, while the remaining outer portion (including an outer surface portion) of the support member is located outside the proximal graft 2000 and coupled to the outer surface of the proximal graft 2000. In other arrangements, the support members are attached, fixed, bonded (e.g., heat-bonded), sutured, or otherwise coupled to the outer surface of the proximal graft 2000. The support members can be expanded using a suitable fill line.

[0155] exist Figure 20A , proximal implant 2000 includes two support members 2001 and 2002. Support member 2001 is located at the proximal end of proximal implant 2000, while support member 2002 is located at the proximal end of proximal implant 2000.

[0156] exist Figure 20B, proximal graft 2000 further includes anchor 2030. Anchor 2030 is a fixation feature, 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.

[0157] exist Figure 20C In the embodiment of the present invention, proximal graft 2000 further includes an expandable structure 2032. In the manner described herein, expandable structure 2032, in the expanded state, can radially expand toward the surface / wall of aorta 10 to fill one or more of: the sac of aneurysm 14 (for sac management); the space between the outer surface of proximal graft 2000 and the surface / wall of proximal neck region 17 (for neck sealing); and the space between the outer surface of branch stent grafts (e.g., branch stent grafts 2012 and 2014) and the surfaces / walls of iliac arteries 12 and 13. Expandable structure 2032 is attached, fixed, bonded (e.g., heat bonded), sutured, or otherwise coupled to at least a portion of the outer surface of proximal graft 2000.

[0158] exist Figure 20D and Figure 20E , proximal graft 2000 includes support members 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 the proximal end of proximal graft 2000 bifurcates into lumens 2034 and 2035 in a docking region at the distal end of proximal graft 2000. The proximal end and the distal end are opposing ends of proximal graft 2000. Branch stent grafts 2012 and 2014 can be docked or inserted into lumens 2034 and 2035 in the manner described herein. In the manner described herein, branch stent grafts 2012 and 2014 include respective ones of expandable structures 2016 and 2018 for balloon management and sealing.

[0159] exist Figure 20F and Figure 20G, proximal graft 2000 includes support members 2001-2003 and anchor 2030. Support member 2003 is located along proximal graft 2000 between support members 2001 and 2002. Support members 2001-2003 are spaced apart from one another along proximal graft 2000. In some arrangements, proximal graft 2000 includes inner sleeves or rings 2044 and 2045 that form cavities 2046 and 2047 for receiving branch stent grafts 2012 and 2014, respectively. Inner sleeves or rings 2044 and 2045 are located within cavity 2020 in the docking region between support members 2002 and 2003. In some examples, inner sleeves or rings 2044 and 2045 can be sleeves or support rings made of a polymer (e.g., PTFE, polyurethane, etc.). The inner sleeves or rings 2044 and 2045 and the bifurcated features may eliminate leakage from the grooves.

[0160] exist Figure 20H and Figure 20I In FIG, the proximal implant 2000 includes support members 2001-2003 and anchor 2030 without any bifurcated features or inner sleeves. Figure 20J , proximal implant 2000 includes support members 2001-2004 and anchor 2030. Support members 2003 and 2004 are located along proximal implant 2000 between support members 2001 and 2002. Support members 2001-2004 are spaced apart from one another along proximal implant 2000.

[0161] exist Figure 20K In FIG, proximal implant 2000 includes support members 2001-2005. Support members 2003-2005 are located between support members 2001 and 2002 along proximal implant 2000. Support members 2001-2005 are spaced apart from each other along proximal implant 2000. Figure 20L , proximal implant 2000 includes support members 2001 - 2005 and anchor 2030 .

[0162] Figure 21A 、 Figure 21B 、 Figure 21C and Figure 21D Examples of proximally extended stent grafts 2100 are shown according to various arrangements. Figure 1 、 Figure 21A 、 Figure 21B 、 Figure 21C and Figure 21DProximal-extension stent-graft 2100 is a proximal stent-graft. Proximal-extension stent-graft 2100 has a proximal end, a distal end, an inner surface, and an outer surface. The proximal end of proximal-extension stent-graft 2100 is the end of proximal-extension stent-graft 2100 that is closer to or located in the proximal neck region 17 when deployed. The distal end of proximal-extension stent-graft 2100 is the end of proximal-extension stent-graft 2100 that is closer to the aortic bifurcation 11 when deployed. Typically, the distal end of proximal-extension stent-graft 2100 can be placed into the sac of an aneurysm 14. Proximal-extension stent-graft 2100 has a cylindrical shape and forms a hole or tubular lumen 2120. The inner surface of proximal-extension stent-graft 2100 faces lumen 2120. The outer surface of proximal-extension stent-graft 2100 faces the wall / surface of aorta 10 and faces away from lumen 2120 when deployed. Blood is configured to flow through the lumen 2120. The proximal extension stent graft 2100 includes a wire-wound stent 2101 having a plurality of wire-wound loops.

[0163] Figure 21B Proximally-extended stent-graft 2100 is shown also including an anchor 2130 similar to anchor 2030 . Figure 21C Proximally-extended stent-graft 2100 is shown also including an expandable structure 2132 similar to expandable structure 2032 .

[0164] Figure 21C and Figure 21D The illustrated proximal extension stent-graft 2100 includes encapsulated wire stents 2134 and 2135 in the docking region at the distal end of the proximal extension stent-graft 2100. The encapsulated wire stents 2134 and 2135 form cavities 2144 and 2145 within lumen 2120. Such encapsulated wire stents 2134 and 2135 allow a branch stent-graft to dock within lumen 2120 of the proximal extension stent-graft 2100. The distal end of the branch stent-graft is oversized (e.g., having a diameter greater than the diameter of cavities 2144 and 2145) such that the branch stent-graft generates an outward radial force relative to the encapsulated wire stents 2134 and 2135 to ensure that the branch stent-graft and the encapsulated wire stents 2134 and 2135 remain engaged.

[0165] In some arrangements, grafts 2000 and 2100 are straight, rigid holes. In some arrangements, grafts 2000 and 2100 are made of a more flexible PTFE material. In embodiments where grafts 2000 and 2100 are made of a flexible PTFE material, grafts 2000 and 2100 can function as active seals when blood pressure within cavities 2020 and 2120 pushes the walls of grafts 2000 and 2100 against the vessel wall of aorta 10. Thus, an active seal is formed between the outer surface of grafts 2000 and 2100 and the vessel wall of aorta 10.

[0166] Figure 22A An example proximally-extending expandable filling structure 2212 of the system 2200 is shown according to various arrangements. Figure 22B is deployed in the aneurysm 14 ( Figure 1 ) on system 2200( Figure 22A ). Figure 1 、 Figure 22A and Figure 22B , system 2200 includes a proximally extending expandable filling structure 2212 , a first branch stent-graft 2213 , a second branch stent-graft 2214 , an anchor 2245 , an expandable filling structure 2216 , and an expandable filling structure 2218 .

[0167] In some examples, the proximal extension expandable filling structure 2212 is an expandable filling structure (e.g., an inner bag). In various examples, the proximal extension expandable filling structure 2212 has a wider polymer-filled sealing area compared to the sealing rings on other devices. As shown, the width of the proximal extension expandable filling structure 2212 is represented as Y. In some examples, Y is approximately 20 mm. As described herein, the wider proximal extension expandable filling structure 2212 is forgiving in terms of placement accuracy, and even if the proximal extension stent graft 2000 is placed in a position lower than the optimal position (e.g., 1 mm lower), the wider proximal extension expandable filling structure 2212 can still provide a tight seal in the proximal neck region 17. The wider proximal extension expandable filling structure 2212 also has a wider range of treatment diameters, which means that the number of sizes required to treat the entire vascular treatment range is smaller (and the number of SKUs is smaller). In some arrangements, the neck length of the proximal extension expandable filling structure 2212 is shorter than the neck length of other devices. Additionally, a wide, proximally extending expandable filling structure 2212 may improve neck angle indication.

[0168] In some arrangements, the proximal extension expandable filling structure 2212 has a filling line 2206 or is in communication with the filling line, through which a hardenable expansion material or filling polymer (e.g., polyester, PTFE, polyurethane, etc.) is circulated in liquid form. The proximal extension expandable filling structure 2212 can be deployed in the proximal neck region 17 using the filling line 2206 and expanded therein. The proximal extension expandable filling structure 2212 forms a seal in the proximal neck region 17 in the expanded state to eliminate type II internal leaks. The proximal extension expandable filling structure 2212 can be filled to a higher pressure than other devices. The proximal extension expandable filling structure 2212 can also provide a more accurate sealing area and a more circumferential seal in the proximal neck region 17. When expandable filling structures 2216 and 2218 are expanded or when branch stent grafts 2213 and 2214 are docked in docking region 2250, proximally extending expandable filling structure 2212 can prevent expandable filling structures 2216 and 2218 from prolapsing into renal arteries 15 and 16. When proximally extending expandable filling structure 2212 forms a seal in proximal neck region 17, lumens 2202 and 2204 are also located in proximal neck region 17.

[0169] As shown, proximally extending expandable filling structure 2212 forms cavities 2202 and 2204 to which branch stent-grafts 2213 and 2214 are docked. Cavities 2202 and 2204 correspond to docking region 2250. When proximally extending expandable filling structure 2212 is in an expanded state, cavities 2202 and 2204 are fully expanded. The dimensions of the fully expanded cavities 2202 and 2204 are slightly smaller than the dimensions of the proximal ends of branch stent-grafts 2213 and 2214. Given the elasticity of the material of proximally extending expandable filling structure 2212 (in its expanded state), the material of proximally extending expandable filling structure 2212 forms a seal around cavities 2202 and 2204 when branch stent-grafts 2213 and 2214 are docked therein.

[0170] In various arrangements, anchor 2245 (fixation feature, fixed stent frame, etc.) anchors, secures, or attaches the proximal end of proximally extending expandable filling structure 2212 to the wall / surface of aorta 10, preventing blood from intruding into the area between the outer wall and inner surface of aneurysm 14 and improving the transition from the aorta 10 into the lumen of proximally extending expandable filling structure 2212. In some examples, anchor 2245 is sutured or stitched to proximally extending expandable filling structure 2212. In some examples, anchor 2245 may comprise a stent, graft, and / or other expandable luminal support structure. In some examples, anchor 2245 is self-expanding and comprises a suprarenal laser-cut stent with a coil attached thereto. In some examples, anchor 2245 has a shorter stent than some current stent-graft systems to eliminate free crowns. The length of anchor 2245 is indicated as X. In some examples, X is approximately 30 mm or less. A shorter stent allows for greater neck angle indication due to improved stent-graft flexibility. Thus, the suprarenal stent of anchor 2245 is shorter and has fewer crowns and fewer anchors, thereby allowing the system 2200 to be used for smaller treatment sizes. That is, the stent graft system 2200 is a low-profile delivery system that can be used for small treatment sizes.

[0171] Expandable filling structure 2216 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of branch stent-graft 2213. Expandable filling structure 2218 is secured, bonded, attached, or otherwise coupled to at least a portion of the outer surface of branch stent-graft 2214. Each expandable filling structure 2216 and 2218 can be expanded using a dedicated fill line or using a fill line shared with other components of system 2200. When expanded, expandable filling structures 2216 and 2218 radially expand from branch stent-grafts 2213 and 2214 toward the surface / wall of the sac of aneurysm 14. In the expanded state, expandable filling structures 2216 and 2218 surround branch stent-grafts 2213 and 2214, respectively.

[0172] Figure 23 Example proximally extending expandable structures of stent graft systems according to various arrangements are shown. Figure 1 and Figure 23, anchor 2245 (fixing feature, fixed stent frame, etc.) anchors, fixes 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 sutured or stitched to the proximal extension expandable filling structure 2312. In some examples, the anchor 2345 can include a stent, graft and / or other expandable cavity support structure. In some examples, the anchor 2345 includes a stent that is connected to or extends from the stent 2320 of the proximal extension expandable filling structure 2312. As shown, the anchor 2345 includes a hook or barb for fixation. In some examples, the anchor 2345 is self-expanding and includes a suprarenal laser-cut stent to which a coil is attached. The proximally extending expandable filling structure 2312 can form two lumens 2302 and 2304 (similar to lumens 2202 and 2204) when expanded.

[0173] Thus, in some arrangements, the stent-graft systems described herein include wider sealing rings that improve placement accuracy while providing a wider range of treatment diameters. In some arrangements, an expandable filling structure (e.g., an endobag) can be provided to prevent type II endoleaks. In some arrangements, a proximal graft with a large pore size is easier to cannulate than the much smaller contra lumen in some other devices. A proximal graft with a large pore size can also reduce or eliminate the possibility of cannulating the wrong lateral (ipsi) lumen.

[0174] With regard to the specific arrangement described in this application, the present technology is not limited, and the specific arrangement is intended to be an illustration of the various aspects of the present technology. As will be apparent to those skilled in the art, many modifications and variations can be made to the present technology without departing from the spirit and scope of the present invention. In addition to those listed herein, from the foregoing description, functionally equivalent systems and methods within the scope of the present technology will be apparent to those skilled in the art. Such modifications and variations are intended to fall within the scope of the present technology. It should be understood that the present technology is not limited to specific systems and methods using systems, which can certainly change. It should also be understood that the terms used herein are only for the purpose of describing specific arrangements and are not intended to be limiting.

Claims

1. A stent graft system comprising: a first graft having a proximal end and a distal end; Second graft; The third graft, an expandable filling structure coupled to the first graft, and at least one support member coupled to said first graft; wherein, prior to deployment, each of the first graft, the second graft, and the third graft is a separate graft and each includes at least one lumen; wherein the second graft and the third graft are configured to be inserted into the lumen of the first graft when deployed, wherein the expandable filling structure extends from a proximal end to a distal end of the first graft and is configured to form a seal in a proximal neck region of the aorta, wherein the at least one support member is embedded in the first graft in order to seal any grooves formed in the lumen of the first graft when the second graft and the third graft are inserted into the lumen of the first graft.

2. The stent graft system of claim 1, the expandable filling structure at least partially surrounding the first graft, the expandable filling structure configured to expand within and contact a wall of the aorta.

3. The stent graft system of claim 1, further comprising an anchor coupled to the first graft.

4. The stent graft system according to claim 2, wherein: The expandable filling structure, when deployed, at least partially surrounds proximal ends of the second graft and the third graft that dock within the lumen of the first graft.

5. The stent graft system according to claim 2, wherein: The second graft and the third graft dock within the lumen of the first graft in the docking region; and The expandable filling structure surrounds at least portions of the second graft and the third graft outside of the docking region in an expanded state.

6. The stent graft system according to claim 1, wherein: The second graft and the third graft dock within the lumen of the first graft in the docking region; and The first graft includes a wire-wound stent component coupled to a portion of the first graft in the docking region, the wire-wound stent component including a plurality of wire-wound loops.

7. The stent graft system according to claim 1, wherein: The second graft and the third graft are docked within the lumen of the first graft in the docking region; The first graft includes a wire stent ring coupled to a portion of the first graft in the docking region, the wire stent ring comprising a single ring of wire stent.

8. The stent graft system according to claim 2, wherein: The expandable filling structure forms a funnel shape in an expanded state.

9. The stent graft system according to claim 2, wherein: The expandable filling structure is a bifurcated expandable filling structure that, in an expanded state, forms two lumens for receiving the second graft and the third graft.

10. The stent graft system of claim 1, further comprising a first expandable filling structure at least partially surrounding said first graft; a second expandable filling structure at least partially surrounding the second graft; as well as A third expandable filling structure at least partially surrounds the third graft, the first expandable filling structure, the second expandable filling structure, and the third expandable filling structure being independent expandable filling structures that expand within the aorta when deployed.

11. The stent graft system of claim 1 , further comprising: a first expandable filling structure, a second expandable filling structure, a third expandable filling structure, the second expandable filling structure at least partially surrounding the second graft; as well as The third expandable filling structure at least partially surrounds the third graft, wherein the second and third expandable filling structures are configured to expand within the aorta and at least partially surround the first graft when deployed.

12. The stent graft system according to claim 11, wherein: Each of the second graft and the third graft includes a wire-wound stent component including a plurality of wire-wound loops.

13. The stent graft system of claim 1, wherein: The first graft includes laminated stent components.

14. The stent graft system of claim 1, wherein: The at least one support member is a fillable structure.

Images