Stent graft systems and methods with inflatable fill structure and fillable cuff

Abstract

To provide stent graft systems and methods of placing such stent graft systems for treating aortic aneurysms.SOLUTION: A stent graft system 100 includes a stent graft, an inflatable fill structure 130, and a cuff 140. The inflatable fill structure 130 at least partially surrounds the stent graft. In various arrangements, the inflatable fill structure 130 has a cavity that is bifurcated. A portion of the cavity is configured to receive a branch stent graft for connection to the stent graft. The cuff 140 is fillable and is located outside of the inflatable fill structure 130, and makes it possible to provide a seal with a wall of a blood vessel. The cuff 140 and the inflatable fill structure 130 are separately fillable from each other to different pressures with a fill medium. In various arrangements, the cuff has a tapered shape such that it is wider at one end than at an opposite end when filled with a fill medium.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED PATENT APPLICATIONS] This application claims priority from U.S. Provisional Patent Application No. 62 / 730,441, filed September 12, 2018, the entire contents of which are incorporated herein by reference.

[0002] The present technology relates generally to endoluminal vascular prostheses and methods of deploying such prostheses. More specifically, various deployments relate to stent-graft systems for treating aortic aneurysms and methods of deploying such stent-graft systems. [Background technology]

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

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

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

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

[0007] Various stent-graft systems and methods described herein relate to treating aneurysms. Various configurations allow for improved sealing and anchoring of the stent-graft system. The stent-graft system according to various configurations includes a stent-graft, an inflatable filling structure, and a cuff. The inflatable filling structure at least partially surrounds the stent-graft. In some configurations, the inflatable filling structure has a branched cavity. The cuff is fillable and positioned outside the inflatable filling structure.

[0008] In various arrangements, a portion of the cavity is configured to receive a branch stent graft for connection to the stent graft. In various arrangements, the cuff is positioned at an end of the stent graft. In some arrangements, the cuff has a tapered shape such that it is wider at one end than at the opposite end when filled with a filling medium. In some arrangements, the stent graft system further includes an inflatable channel positioned at least partially around the stent graft and surrounded by an inflatable filling structure. In various arrangements, the cuff and the inflatable filling structure are separately fillable with a filling medium to different pressures.

[0009] In various arrangements, the inflatable filling structure is configured so that the branched cavity is longer on one side of the branch than on the other side of the branch. In some arrangements, a skeletal mechanism is positioned in the cavity at least partially in an area where the branch stent graft is insertable into the cavity, the skeletal mechanism configured to provide structural support to the inflatable filling structure before the branch stent graft is received in the cavity. Also, in some arrangements, the stent graft system further includes longitudinal support structures anchored to ends of the inflatable filling structure and structurally coupled to the skeletal mechanism. In various arrangements, the stent graft includes an integrally formed main stent graft and branch stent graft, the main stent graft including a cavity for receiving a second branch stent graft.

[0010] A method according to various aspects provides for using a stent-graft system including a stent-graft, an inflatable filling structure, and a cuff. The method includes filling an inflatable filling structure at least partially surrounding the stent-graft and having a branched cavity, and filling a cuff positioned outside the inflatable filling structure to form a seal with the wall of the vessel. In various aspects, the method further includes inserting a branch stent-graft into the cavity of the inflatable filling structure. Also, in various aspects, the method further includes inserting the branch stent-graft at least partially into the stent-graft.

[0011] In various aspects, the cuff and the inflatable filling structure are filled to different pressures. For example, in some aspects, the cuff is filled to a pressure higher than the filling pressure of the inflatable filling structure. In some aspects, the cuff is sized so that when filled, it extends from the bottom of the renal arteries to the top of the aneurysm so that it forms a seal across the proximal stenotic region of the aorta. In various aspects, the method further includes filling an inflatable channel at least partially positioned around the stent graft and surrounded by the inflatable filling structure.

[0012] In various arrangements, the cuff has a tapered shape so that when filled, it is wider at one end than at the opposite end. Also, in some arrangements, one side of the inflatable filling structure surrounding the first branch stent graft is longer than another side of the inflatable filling structure surrounding the second branch stent graft. In some aspects, the method further includes structurally supporting a portion of the cavity of the inflatable filling structure that is separate from the stent graft prior to inserting the branch stent graft into this portion of the cavity with a skeletal mechanism. In some arrangements, the stent graft system further includes longitudinal support structures structurally coupled to the skeletal mechanism that anchor to ends of the inflatable filling structure and structurally support the inflatable filling structure.

[0013] In various arrangements, the stent-graft system includes a stent-graft, an inflatable filling structure at least partially surrounding the stent-graft, and a fillable cuff positioned external to the inflatable filling structure. In some arrangements, at least one inflatable filling structure can have at least one cavity. In some arrangements, the inflatable filling structure includes multiple individual cavities. In some arrangements, the inflatable filling structure includes branch cavities. The inflatable filling structure can include cavities configured to provide access to multiple arteries, such as the iliac arteries and the renal arteries. In some arrangements, the inflatable filling structure includes cavities configured for fluid communication with the iliac arteries, the renal arteries, or both. In some arrangements, the system includes a fenestrated stent-graft. Thus, the system can include a branch stent-graft anchored to the iliac arteries and / or the renal arteries. In some arrangements, the system includes multiple inflatable filling structures, at least some of which are attached to the stent-graft. At least some of the filling structures may be attached to other filling structures. [Brief explanation of the drawings]

[0014] [Figure 1] 1A-1C are cross-sectional views of an embodiment of a stent-graft system deployed across an aneurysm in various configurations. [Figure 2] 2A-2C show the stent graft system of FIG. 1 with the inflatable filling structure in various configurations. [Figure 3] 1A-1C show a stent graft system with an inflatable filling structure in various configurations. [Figure 4] 1A-1C show a stent graft system with branched inflatable filling structures in various configurations. [Figure 5] 5A-5C show the stent graft system of FIG. 4 with the branch stent graft inserted into the branch inflatable filling structure in various configurations. [Figure 6] 1A-1C are cross-sectional views of an embodiment of a stent-graft system deployed across an aneurysm in various configurations. [Figure 7] 1A-1C show a stent graft system with an inflatable filling structure in various configurations. [Figure 8] 1A-1C are cross-sectional views of an embodiment of a stent graft system having a main inflatable filling structure and two branch inflatable filling structures deployed across an aneurysm in various configurations. [Figure 9] 1A-1C show a stent graft system with branched inflatable filling structures in various configurations. [Figure 10] 1A-1C are cross-sectional views of an embodiment of a stent graft system having a branched inflatable filling structure deployed across an aneurysm in various configurations. [Figure 11] 1A-1C show a stent graft system with branched inflatable filling structures in various configurations. [Figure 12] 10A-10C show inflatable filling structures in various configurations. [Figure 13A] 1 is a flow diagram of a method of using a stent graft system in accordance with various aspects. [Figure 13B] 13B illustrates steps that can be used in conjunction with the method of FIG. 13A according to various embodiments. [Figure 13C] 13B illustrates steps that can be used in conjunction with the method of FIG. 13A according to various embodiments. [Figure 13D] 13B illustrates steps that can be used in conjunction with the method of FIG. 13A according to various embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0015] Various configurations are described below. It should be noted that a particular configuration is not intended to be exhaustive or a limitation on the broad range of aspects discussed herein. An aspect described with respect to a particular configuration is not necessarily limited to that configuration and can be implemented with any other configuration.

[0016] Figure 1 shows cross-sectional views of an embodiment of a stent-graft system 100 deployed across an aneurysm 102 in various configurations. Figure 2 illustrates a stent-graft system 100 with an inflatable filling structure 130 in various configurations. With reference to Figures 1 and 2, the aneurysm 102 is defined by an aneurysmal sac, which is a bulging section of the aorta 101. The illustrated aneurysm 102 is an infrarenal aortic aneurysm, assuming it is below the renal arteries 108a and 108b. The segment of the aorta 101 between the renal arteries 108a and 108b and the aneurysmal sac is referred to as the proximal stenosis 106.

[0017] The stent-graft system 100 includes a first stent-graft 112 and a second stent-graft 114. In some examples, the second stent-graft 114 is a bifurcated stent-graft. In some examples, the first stent-graft 112 is a proximal extension stent-graft. The second stent-graft 114 has a proximal end, a distal end, and an outer surface. The second stent-graft 114 may be positioned over the aortic bifurcation 104. The aortic bifurcation 104 is where the aorta 101 branches into two iliac arteries, as shown. The stent-graft system 100 includes an inflatable filling structure 130 that at least partially surrounds the first stent-graft 112 and the second stent-graft 114. The inflatable filling structure 130 is fillable with a filling medium 132. In various examples, the inflatable filling structure 130 is an internal bag secured to a portion of the outer surface of the second stent graft 114 and includes an outer membrane configured to extend beyond the proximal end of the second stent graft 114 when the inflatable filling structure 130 is in a filled state in some arrangements. In other arrangements, the outer membrane of the internal bag corresponding to the inflatable filling structure 130 does not extend beyond the proximal end of the second stent graft 114.

[0018] The stent-graft system 100 can be deployed across the aneurysm 102 in any suitable manner. For example, first, a second stent-graft 114 having an inflatable filling structure 130 is positioned over the aortic bifurcation 104. The inflatable filling structure 130 is initially in an uninflated state. The first stent-graft 112 is at least partially nested within the main body of the second stent-graft 114. For example, an end of the first stent-graft 112 is inserted into the proximal end of the second stent-graft 114. In this manner, the first stent-graft 112 can extend the aneurysm repair into the proximal stenosis 106. In various examples, the second stent-graft 114 is not bifurcated and can be easily adapted to or used in any aneurysm repair using a stent and an inflatable filling structure. In various examples, other types of extension stent-grafts can be nested within any of the illumination openings in the second stent-graft 114.

[0019] The inflatable filling structure 130 is then filled with a filling medium 132 to achieve an expanded or filled state. The filling medium 132 presses the walls of the inflatable filling structure 130 against the aneurysm 102. A portion of the inflatable filling structure 130 extends proximally into the space of the aneurysm 102 adjacent the first stent-graft 112. That is, when in an uninflated state, the inflatable filling structure 130 may be confined to surround the second stent-graft 114, but when inflated to a filled state as shown, the inflatable filling structure 130 expands radially and proximally to fill all (or most) of the aneurysm 102, including at least a portion of the space around the first stent-graft 112 that is not covered by the second stent-graft 114. When the inflatable filling structure 130 is filled, the walls of the inflatable filling structure may conform to the interior walls of the aneurysm 102. When the inflatable filling structure 130 is filled, the walls of the inflatable filling structure can conform to at least a portion of the outer surface of the first stent graft 112 and at least a portion of the outer surface of the second stent graft 114. The inflatable filling structure 130 is configured to extend beyond the proximal end of the second stent graft 114 when in the filled state, and thus surround at least a portion of the first stent graft 112. In other examples, the inflatable filling structure 130 only covers the second stent graft 114 (in the filled state). In some embodiments, the inflatable filling structure 130 does not cover the bifurcation portion of the second stent graft 114.

[0020] In any of the configurations described herein, the endovascular graft system (e.g., stent-graft system 100) can be anchored at proximal and / or distal sealing locations (at the proximal stenosis 106 and the iliac arteries (e.g., at the aortic bifurcation 104)) when treating an infrarenal aortic aneurysm. The stent-graft system 100 includes additional sealing or locking mechanisms, including a cuff 140 and a stent-like scaffold structure 145, as shown. In various configurations, the locking mechanisms include, but are not limited to, stents, scaffolds, hooks, barbs, seals, and / or sealing cuffs. In some configurations, for a sealing cuff or stent extending proximally of an infrarenal prosthesis, it may be desirable to provide an opening or port to allow the locking or sealing device to extend across the renal ostium while percolating blood flows into the renal arteries. In various arrangements, the sealing or locking device is attached to and / or overlaps the filling structure of the prosthesis, allowing a smooth transition from the aortic and / or iliac lumen into the tubular lumen formed by the deployed filling structure.

[0021] In addition to the filling structure described above, a graft system (e.g., stent-graft system 100) can further include at least a first scaffold separate from the filling structure, which can expand within the generally tubular lumen to allow blood flow after the filling structure is deployed within the aneurysm. The first scaffold, which is adapted to expand within at least a first portion of the tubular lumen of the filling structure, can provide one or more specific advantages. For example, the scaffold can support and smooth the inner wall of the tubular lumen, which in some cases may otherwise become uneven during hardening of the polymer filling material. The scaffold can enable anchoring of the filling structure, particularly at the aortic end of the graft, when placed in the AAA. The scaffold can be partially or completely covered with a membrane to form a stent-graft. In such cases, the graft structure can serve to allow transition of the filling structure from the aortic end into the generally tubular lumen. Alternatively, the graft structure can allow one or two transitions of the filling structure from the iliac end. In certain instances, graft structures can be used on either side of the filling structure to treat additional or continuing aneurysmal regions in adjacent vessels. In either configuration, the system can include multiple scaffold structures. For example, the system can include at least first and second scaffolds, one for each tubular lumen defined by the first and second double-walled filling structures, respectively. The scaffolds can be arranged in series, often overlapping, or spaced apart at either or both ends, or optionally in the region between the ends.

[0022] In various arrangements, a stent-like skeletal structure 145 can be implanted into the upper proximal opening of the tubular lumen of the filling structure (e.g., at the edge of the cuff 140) to help anchor the upper end of the filling structure (e.g., the cuff 140 and the first stent graft 112), prevent blood from entering the area between the outer and inner walls of the aneurysm 102, and generally improve the transition from the aorta 101 into the tubular lumen. The stent-like skeletal structure 145 can include a stent, graft, and / or other expandable luminal support structure. The first stent graft 112 can include one or more circumferential inflatable channels that can extend around the circumference of the graft body or extend partially around the circumference of the graft body. The circumferential inflatable channels can be in communication with each other through a longitudinal inflatable filling channel. Optionally, the network of inflatable channels can be filled with a hardenable material that can be configured to harden, solidify, or otherwise become more viscous or firmer after being injected into the channels. A hardenable expansion material, such as a gel, liquid, or other flowable material that can be set to a more solid or substantially hardened state, can be used to provide mechanical support to the graft body through the mechanical properties of the hardened material disposed within the channels. In some arrangements, the filler material is a saline solution. In some arrangements, the filler material is a gas.

[0023] Stent graft materials used for the stent graft system 100 include, but are not limited to, polyester, ePTFE, polyurethane, and the like. For example, in some arrangements, the cuff 140 has a filling line or channel that is used to fill with a liquid polymer (e.g., polyester, ePTFE, polyurethane, and the like). In some arrangements, the cuff 140 can have a different filling line compared to the rest of the stent graft system 100 (e.g., the inflatable filling structure 130). Thus, when installing the stent graft system 100, a first filling line is used to inject polymer into the inflatable filling structure 130 and a second filling line is used to inject polymer into the cuff 140.

[0024] In some arrangements, the cuff 140 is fabricated from a different material compared to the stent graft material for the rest of the stent graft system 100. In some arrangements, the cuff 140 is fabricated from the same material as the stent graft material for the rest of the stent graft system 100. In some arrangements, a polymer is filled into the cuff 140 through a filling line at a higher pressure compared to that used to fill the rest of the stent graft system 100 (e.g., the inflatable filling structure 130). For example, the inflatable filling structure 130 can be filled to 0-250 mmHg, 180-250 mmHg, 0-100 mmHg, or 100-250 mmHg. The cuff 140 can be filled to 180 mmHg-760 mmHg (1 atmosphere). The cuff 140 can be filled at a higher pressure because it is in contact with healthy tissue that has the ability to handle higher pressures for sealing or locking purposes. In contrast, the inflatable filling structure 130 contacts the aneurysm sac (unhealthy tissue) and therefore must be filled at a lower pressure. In some instances, the same filling line can be used to fill the cuff 140 and the inflatable filling structure 130 at different pressures. In other instances, different filling lines can be used to fill the cuff 140 and the inflatable filling structure 130 at different pressures. The cuff 140 (e.g., a deflated version shown as cuff 340 in FIG. 3) can be inflated, thereby forming a unitary structure when the polymer enters a solidified state.

[0025] Referring to FIG. 1 , the size of the aneurysm 102 can vary significantly from patient to patient. The diameter of the proximal stenosis 106 can vary, for example, from 18 millimeters (mm) to 34 mm. The distance from the aortic bifurcation 104 to the renal arteries 108a and 108b can vary, for example, from 80 mm to 160 mm. The diameter of the right iliac artery and the diameter of the left iliac artery may not be the same. The diameter of the iliac arteries at the aortic bifurcation 104 can vary, for example, from 8 mm to 20 mm. One or both iliac arteries can be aneurysmal, for example, with a dilated diameter greater than 30 mm.

[0026] Thus, the sealing and locking mechanism (e.g., at least the cuff 140) can be configured to accommodate various sizes of aorta 101, for example, particularly various sizes of proximal stenosis 106. In some examples, as shown in FIG. 1 , the cuff 140 continuously contacts the inner wall of the proximal stenosis 106, providing continuous sealing and locking for the proximal stenosis 106 in the portion of the aorta 101 between the beginning of the aneurysmal sac of the aneurysm 102 and the renal arteries 108a and 108b. Continuous contact with the inner wall of the proximal stenosis 106 refers to the fact that the cuff 140, when filled, fully contacts this inner wall to form a fluid seal therewith, or that it continuously contacts the entire inner wall of the proximal stenosis 106 without any portion of the cuff 140 not contacting the inner wall. A stent-like framework 145 is disposed on one end of the cuff 140. The opposite end of the cuff 140 abuts the end of the first stent-graft 112.

[0027] In some instances, the cuff 140 and the first stent graft 112 are uniformly formed as a single jointed piece. The cuff 140 is configured to continuously contact the inner wall of the proximal stenosis 106 from the stent-like skeletal structure 145 to the end of the first stent graft 112. Continuous contact of the inner wall of the proximal stenosis 106 from the stent-like skeletal structure 145 to the end of the first stent graft 112 refers to the fact that the cuff 140, when filled, continuously contacts the entire inner wall from the stent-like skeletal structure 145 to the end of the first stent graft 112, without any part of the cuff 140 not contacting the inner wall of the proximal stenosis 106 between the stent-like skeletal structure 145 and the end of the first stent graft 112. In some instances, the cuff 140, when filled, may not contact the inner wall of the proximal stenosis 106 all the way to the end of the first stent graft 112. A gap may exist between the cuff 140 (when filled) and the first stent graft 112. The inflatable filling structure 130 may be inflated to fill this gap.

[0028] Some anchoring mechanisms at the proximal stenosis 106 between the stent-like framework 145 to the end of the first stent graft 112 or between the start of the aneurysm sac and the renal arteries 108a and 108b use two or more cuffs with a smaller width than that shown for cuff 140. Fabricating a dual cuff structure includes creating a weld line in the middle of the cuff material such that when the cuff material is filled with a polymer, two or more cuffs are formed at the proximal stenosis 106 between the stent-like framework 145 to the end of the first stent graft 112 or between the start of the aneurysm sac and the renal arteries 108a and 108b.

[0029] The cuff 140 (e.g., one long, continuous cuff at the proximal stenosis 106) can be advantageous over a multi-cuff arrangement because it provides a larger contact surface for improved sealing and locking given the increased and improved friction fit. Furthermore, the cuff material comprising the cuff 140 can expand to a larger volume compared to the combined volume achievable with a multi-cuff arrangement. This allows for improved radial expansion to accommodate proximal stenosis 106 sizes (e.g., widths or diameters). For example, when the cuff 140 is filled with a polymer, the volume of the cuff material expands until the inflating cuff 140 contacts the inner wall of the proximal stenosis 106. When there is no more room along the diameter of the proximal stenosis 106, the inflating cuff 140 expands longitudinally until fully inflated, further filling the proximal stenosis 106. In various arrangements, the cuff 140 is an elongated cuff.

[0030] The cuff 140 also improves precision and increases the treatment range for the entire stent-graft system 100. Once the cuff 140 expands to the point where it contacts the inner wall of the proximal stenosis 106, it then expands longitudinally within the proximal stenosis 106. This allows the stent-graft system 100 with the cuff 140 to accommodate a larger range of vessel sizes. Thus, fewer sizes of cuffs 140 can be manufactured, improving product / implementation flexibility and cost.

[0031] In some examples, the cuff 140 can be formed uniformly with the first stent graft 112. First, the second stent graft 114 with the uninflated inflatable filling structure 130 is placed at the aortic bifurcation 104. The first stent graft 112 with the uninflated cuff 140 is then inserted into the lumen formed by the second stent graft 114, so that a portion of the first stent graft 112 overlaps a portion of the second stent graft 114. The inflatable filling structure 130 and the cuff 140 can then be filled separately (e.g., using separate filling lines). The two-piece assembly of the stent graft system 100 thus allows for modular installation of the cuff 140 as an integral part of the first stent graft 112.

[0032] The other cuffs shown and described herein provide similar benefits.

[0033] FIG. 3 illustrates a stent-graft system 300 having an inflatable filling structure 330 in various configurations. Referring to FIGS. 1, 2, and 3, the stent-graft system 300 is similar to the stent-graft system 100, having a stent-like skeletal structure 345 similar to the stent-like skeletal structure 145 and an inflatable filling structure 330 fillable with a filling medium 332 similar to the inflatable filling structure 130 fillable with a filling medium 132. The stent-graft system 300 of FIG. 3 includes a single stent-graft 312 instead of the two modular stent-grafts 112 and 114 of FIGS. 1 and 2. In other words, the inflatable filling structure 330, the cuff 340 (shown in an unfilled state), and the stent-graft 312 form a single body. The inflatable filling structure 330 is provided on the exterior surface of the stent-graft 312. The stent-graft 312 has a bifurcated portion.

[0034] Figure 4 shows a stent-graft system 400 with a branched inflatable filling structure 430 in various configurations. Figure 5 shows the stent-graft system 400 of Figure 4 with a branched stent-graft 418 inserted into the branched inflatable filling structure 430 in various configurations. Referring to Figures 1, 2, 3, 4 and 5, stent-graft system 400 is similar to stent-graft system 300 and includes a stent-like skeletal structure 445 similar to stent-like skeletal structure 345 and an inflatable filling structure 430 fillable with a filling medium 432 similar to inflatable filling structure 330 fillable with a filling medium 332.

[0035] The stent-graft system 400 includes a stent-graft 412. The inflatable filling structure 430, the cuff 440 (shown in a filled state in FIG. 4 and in an unfilled state in FIG. 5), and the stent-graft 412 form a unitary body. The stent-graft 412 includes a main stent-graft 414 and a branch stent-graft 416. In some examples, the main stent-graft 414 and the branch stent-graft 416 are fabricated from the same continuous wire extending from a limb portion (one branch of a branch) to the main body portion. In other examples, the main stent-graft 414 and the branch stent-graft 416 are fabricated from separate wires. The main stent-graft 414 and the branch stent-graft 416 form a unitary body. The stent-graft 412 is placed within a cavity 434 or space of the branch inflatable filling structure 430, and the cavity 434 is shaped in a branched manner as shown. For example, the cavity 434 is shaped according to the shapes of the main stent graft 412, the branch stent graft 416, and the inserted branch stent graft 418. In this regard, the cavity 434 includes a cavity portion for receiving the branch stent graft 418.

[0036] The branch stent graft 418 is separate from the stent graft 412 and is insertable through a portion of a molded cavity 434 similar to the branch stent graft 418. Additionally, the stent graft 412 also includes a cavity that allows for the insertion of the branch stent graft 418 (e.g., where the main stent graft 414 and branch stent graft 416 intersect). The branch inflatable filling structure 430 thus extends from the portion of the main stent graft 414 near or at the cuff 440 across the aortic bifurcation and provides structural support to the aorta accordingly. In some examples, each portion of the stent graft (e.g., stent grafts 112, 114, 312, 412, 414, 416, and 418) includes plications in the graft material to allow for telescopic expansion and compression. Referring to FIGS. 1, 4, and 5, stent graft system 400 can be used to repair aorta 101 in a manner similar to stent graft system 100.

[0037] The stent-graft system 400 in various configurations includes a stent-graft 412, an inflatable filling structure 430, and a cuff 440. The inflatable filling structure 430 at least partially surrounds the stent-graft 412. The inflatable filling structure 430 has a branched cavity 434. The cuff 440 is fillable and is positioned outside the inflatable filling structure 430. In various configurations, a portion of the cavity 434 is configured to receive a branched stent-graft 418 for connection to the stent-graft 412. In various configurations, the cuff 440 is positioned at an end of the stent-graft 412. In some configurations, the cuff 440 has a tapered shape such that it is wider at one end than the opposite end when filled with a filling medium. In some arrangements, the stent-graft system 400 may further include an inflatable channel positioned at least partially around the stent-graft 412 and surrounded by the inflatable filling structure 430. An example of an inflatable channel around a stent-graft is shown in Figure 6 and may be used around the stent-graft 412 in the stent-graft systems 400 of Figures 4 and 5. In various arrangements, the cuff 440 and the inflatable filling structure 430 may be filled separately from one another to different pressures with a filling medium.

[0038] In various arrangements, the inflatable filling structure 430 is configured such that the cavity 434 is longer on one side of the bifurcation than on the other side of the bifurcation. In some arrangements, a skeletal mechanism is positioned at least partially in the cavity 434 in the area where the branch stent graft 418 can be inserted, the skeletal mechanism being configured to provide structural support to the inflatable filling structure 430 before the branch stent graft 418 is received within the cavity 434. Also, in some arrangements, the stent graft system 400 further includes longitudinal support structures anchored to the ends of the inflatable filling structure 430 and structurally coupled to the skeletal mechanism. Examples of skeletal mechanisms and longitudinal support structures are shown in Figure 12 and may be used in the stent graft systems 400 of Figures 4 and 5. In various configurations, the stent graft 412 includes an integrally formed main stent graft 414 and branch stent graft 416 , with the main stent graft 414 including a cavity for receiving the branch stent graft 418 .

[0039] Figure 13A is a flow diagram of a method according to an embodiment for using the stent-graft system 400 of Figures 4 and 5. With reference to Figures 1, 4, 5, and 13A, the method includes step 1300 of filling an inflatable filling structure 430 at least partially surrounding the stent-graft 412 and having a branched cavity 434, and step 1310 of filling a cuff 440 positioned on the outside of the inflatable filling structure 430 to form a seal with a vessel wall, such as the wall of the proximal stenosis 106 of the aorta 101. Figure 13B illustrates additional steps that can be used in conjunction with the method of Figure 13A. With reference to Figures 1, 4, 5, and 13B, in various embodiments, the method further includes step 1320 of inserting a branched stent-graft 418 into the cavity 434 of the inflatable filling structure 430. Also, in various aspects, the method further includes step 1330 of inserting the branch stent graft 418 at least partially within the stent graft 412. In some instances, the illustrated steps may be performed in a different order.

[0040] In various embodiments, the cuff 440 and the inflatable filling structure 430 are filled to different pressures. For example, in some embodiments, the cuff 440 is filled to a pressure that is higher than the filling pressure of the inflatable filling structure 430. In some embodiments, the cuff 440 is sized to extend from the bottom of the regional renal arteries 108 a and 108 b to the top of the aneurysm 102 so that, when filled, it forms a seal across the proximal stenosis 106 region of the aorta 101. In various embodiments, the method further includes filling an inflatable channel that may be positioned at least partially around the stent graft 412 and surrounded by the inflatable filling structure 430.

[0041] In various arrangements, the cuff 440 has a tapered shape such that when filled, it is wider at one end than at the opposite end. Furthermore, in some arrangements, one side of the inflatable filling structure 430 surrounding the branch stent graft 416 is longer than another side of the inflatable filling structure 430 surrounding the branch stent graft 418. In some aspects, the method further includes using a skeletal mechanism to structurally support a portion of the cavity 434 of the inflatable filling structure 430 that is separate from the stent graft 412 prior to inserting the branch stent graft 418 into this portion of the cavity 434. In some arrangements, the stent graft system 400 further includes longitudinal support structures structurally coupled to the skeletal mechanism that are anchored to the ends of the inflatable filling structure 430 and provide structural support for the inflatable filling structure 430. Examples of skeletal mechanisms and longitudinal support structures are shown in FIG. 12 and may be used with the stent graft systems 400 of FIGS. 4 and 5.

[0042] Figure 6 is a cross-sectional view of an embodiment of a stent-graft system 600 deployed across an aneurysm 102 in an aorta 101 in various configurations. Figure 7 illustrates the stent-graft system 600 of Figure 6 in various configurations. Referring to Figures 3, 6, and 7, stent-graft system 600 is similar to stent-graft system 300 shown in Figure 3. Stent-graft system 600 includes a stent-like skeletal structure 645 similar to stent-like skeletal structure 345, an inflatable filling structure 630 fillable with a filling medium 632 similar to inflatable filling structure 330 fillable with a filling medium 332, and a cuff 640 similar to cuff 340. Stent-graft system 600 includes a bifurcated stent-graft 612. For simplicity, the bifurcated portion of stent-graft 612 is not shown in Figure 7.

[0043] 6 and 7, instead of or in addition to a metal framework, the stent graft 612 can be filled with a polymer to provide structural integrity. In various configurations, the stent graft 612 includes an inflatable channel 613 that can be filled with a polymer to provide structural integrity thereto. The inflatable channel 613 shown in FIG. 6 can be used in the same manner as the stent graft 412 of FIG. 4. Referring to FIG. 6, an inflatable filling structure 630 can be filled to fill the space within the aneurysm 102 between the aortic bifurcation 104 and the proximal stenosis 106. A cuff 640 can be filled to form a seal against the wall of the proximal stenosis 106 between the renal arteries 108a and 108b and the aneurysmal sac of the aneurysm 102.

[0044] FIG. 8 is a cross-sectional view of an embodiment of a stent-graft system 800 having a main inflatable filling structure 830 deployed across an aneurysm 102 in various configurations and two branch inflatable filling structures 834 and 836 deployed within the iliac arteries. Referring to FIG. 8 , the stent-graft system 800 includes a main stent-graft 812 coupled to branch stent-grafts 814 and 816. The main stent-graft 812 is attached to an inflatable filling structure 830 that is fillable with a filling medium 832. The branch stent-grafts 814 and 816 are attached to branch inflatable filling structures 834 and 836, respectively. In some configurations, the stent-grafts 812, 814, and 816 are separate from one another and include inflatable channels that can be filled with a polymer using different filling lines to provide structural integrity. In some configurations, two or more of the stent-grafts 812, 814, and 816 form a single body that is filled using the same filling line. In some arrangements, inflatable filling structures 830, 834, and 836 are separate from one another and are filled with polymer using different fill lines, while in some arrangements, two or more of inflatable filling structures 830, 834, and 836 form a unitary body that is filled with polymer using the same fill line.

[0045] The inflatable filling structure 830 is inflatable to fill the space within the aneurysm 102 between the aortic bifurcation 104 and the proximal stenosis 106. The stent-graft system 800 includes a cuff 840 that is inflatable to form a seal against the wall of the proximal stenosis 106 between the renal arteries 108 a and 108 b and the aneurysmal sac of the aneurysm 102 within the aorta 101. The stent-graft system 800 further includes a stent-like framework 845 for anchoring the stent-graft system 800 to the aorta 101.

[0046] Figure 9 illustrates a stent-graft system 900 having a branch inflatable filling structure 930 in various configurations. Referring to Figure 9, the stent-graft system 900 comprises a stent-like scaffold structure 945 and an inflatable filling structure 930 that is fillable with a filling medium 932. The stent-graft system 900 further comprises a stent-graft 912 and a cuff 940. In various configurations, the inflatable filling structure 930, the cuff 940 (shown in an unfilled state), and the stent-graft 912 form a unitary body. The stent-graft 912 comprises a main stent-graft 914 and branch stent-grafts 916 and 918. The main stent-graft 914 and the branch stent-grafts 916 and 918 form a unitary body. The stent graft 912 is placed into the cavity 934 or space of the branch inflatable filling structure 930, and the cavity 934 is shaped in a branched manner as shown, for example, the cavity 934 is shaped according to the shape of the main stent graft 914 and the branch stent grafts 916 and 918.

[0047] The branch inflatable filling structure 930 thus extends from the portion of the main stent graft 914 near or at the cuff 940 and beyond the aortic bifurcation, providing structural support to the aorta accordingly. The branch stent graft 916 may have a metallic framework and may be longer than the branch stent graft 918. The portion of the inflatable filling structure 930 adjacent the branch stent graft 916 extends from the bifurcation to fit with the branch stent graft 916 and is therefore longer than the portion of the inflatable filling structure 930 adjacent the branch stent graft 918. In various embodiments, the main stent graft 914 includes an inflatable channel 915 that is fillable with a filling medium. In other embodiments, the branch stent graft 918 also includes an inflatable channel that is fillable with a filling medium.

[0048] The method of Figure 13A can be employed when using the stent-graft system 900 of Figure 9. With reference to Figures 1, 9, and 13A, the method includes step 1300 of filling an inflatable filling structure 930 at least partially surrounding the stent-graft 912 and having a branched cavity 934, and step 1310 of filling a cuff 940 positioned on the outside of the inflatable filling structure 930 to form a seal with a vessel wall, such as the wall of the proximal stenosis 106 of the aorta 101. Figure 13C shows additional steps that can be used in conjunction with the method of Figure 13A. With reference to Figures 9 and 13C, step 1340 includes filling an inflatable channel 915 positioned at least partially around the stent-graft 912 and surrounded by the inflatable filling structure 930.

[0049] FIG. 10 shows cross-sectional views of an embodiment of a stent-graft system 1000 having a branch inflatable filling structure 1030 deployed across an aneurysm 102 in various configurations. FIG. 11 illustrates the stent-graft system 1000 of FIG. 10 having a branch inflatable filling structure 1030 in various configurations. With reference to FIGS. 10 and 11 , in various configurations, the branch portions of the branch inflatable filling structure 1030 can have the same or approximately the same length, particularly when the branch stent grafts 1014 and 1016 have the same or approximately the same length. In some configurations, the branch portions of the branch inflatable filling structure 1030 have different lengths. The stent-graft system 1000 further includes a main stent graft 1012, an inflatable channel 1015, a cuff 1040, and a stent-like framework structure 1045. The inflatable filling structure 1030 is fillable with a filling medium 1032.

[0050] A filling line 1050 extends through the branch stent graft 1016 and the main stent graft 1012 to allow the cuff 1040 to be filled with one or more polymers. In some arrangements where the cuff 1040 and the main stent graft 1012 are formed as a single body, the filling line 1050 may fill both the cuff 1040 and the inflatable channel 1015 with a polymer. In some arrangements where the cuff 1040, the main stent graft 1012 and one or both of the branch stent grafts 1014 and 1016 are formed as a single body, the filling line 1050 may fill the inflatable channels of the single body with a polymer.

[0051] The inflatable filling structure 1030 is inflatable to fill the space within the aneurysm 102 between the aortic bifurcation 104 and the proximal stenosis 106. The stent-graft system 1000 includes a cuff 1040 that is inflatable to form a seal against the wall of the proximal stenosis 106 between the renal arteries 108 a and 108 b and the aneurysmal sac of the aneurysm 102 within the aorta 101. The stent-graft system 1000 further includes a stent-like framework 1045 for anchoring the stent-graft system 1000 to the aorta 101.

[0052] FIG. 12 illustrates a branched inflatable filling structure 1200 in various configurations. Referring to FIG. 12, the branched inflatable filling structure 1200 has a cavity 1210 capable of receiving a stent-graft (as shown and described herein). The cavity 1210 is bifurcated and approximates the shape of a branched stent-graft (as shown and described herein). A skeletal mechanism 1220 may be provided in the branch cavity of the cavity 1210 to provide structural support before the stent-graft is received in the cavity 1210. A longitudinal structural support 1240 may be anchored (e.g., hooked) at one end to an upper portion of the inflatable filling structure 1200 adjacent the proximal stenosis and structurally coupled (e.g., hooked) to the skeletal mechanism 1220 to provide longitudinal support before the stent-graft is received. A filling line 1230 may fill the inflatable channels of the inflatable filling structure 1200 and / or the stent-graft and cuff.

[0053] In various arrangements, the skeletal mechanism 1220 and longitudinal structural supports 1240 are used in conjunction with the branched inflatable filling structure 430 of Figure 4 in the same manner as they are used in conjunction with the branched inflatable filling structure 1200 of Figure 12. Figure 13D illustrates a method step that can be used in conjunction with the method of Figure 13A. With reference to Figures 12 and 13D, step 1350 involves structurally supporting a portion of the cavity 1210 of the inflatable filling structure 1200, separate from the stent graft, with the skeletal mechanism 1220 prior to inserting the branched stent graft into this portion. This method step, when the skeletal mechanism 1220 and longitudinal structural supports 1240 are used in conjunction with the inflatable filling structure 430 of Figure 4, can be used with the stent graft system 400 in the same manner as they are used in conjunction with the branched inflatable filling structure 1200 of Figure 12.

[0054] As shown in these figures, in various configurations, the size (e.g., diameter) of the cuff when filled with polymer is larger than the size (e.g., diameter) of the corresponding stent-graft, even when the same size material is used for both the cuff and the stent-graft body. Increasing the longitudinal dimension of the cuff (along the longer dimension of the stent-graft) can also increase the diameter of the cuff due to foreshortening. Length contraction along the longitudinal dimension causes diametric slack in the cuff material, allowing the cuff to expand diametrically. In particular, the cuffs disclosed herein can have a toroidal or link-like structure having an inner diameter and an outer diameter. The volume of the toroid (between the inner and outer diameters) can be filled with polymer. In various configurations, the stent-graft bodies disclosed herein have a cylindrical shape with an axial bore (lumen), with the inner diameter defining the axial bore and the outer diameter defining the cylindrical shape. In various configurations, the volume of the stent-graft body (between the inner and outer diameters) can be filled with polymer within the inflatable channel. In some instances, the difference between the inner and outer diameters of the cuff is greater than the difference between the inner and outer diameters of the stent-graft body due to foreshortening when both the cuff and stent-graft body are filled.

[0055] Additionally, as shown in Figure 7, the cuff 640 is tapered, which allows the cuff 640 to completely fill within a proximal stenosis having a tapered shape, i.e., the cuffs described herein can also accommodate different shapes of the proximal stenosis of an aneurysm.

[0056] A stent-graft system according to various embodiments includes a stent-graft and an anchoring mechanism. The stent-graft is configured to form a lumen when structurally supported within a blood vessel. The anchoring mechanism is configured to provide anchoring and sealing at a proximal stenosis of the blood vessel. The anchoring mechanism includes a cuff fabricated from a first expandable material having a first inner diameter and a first outer diameter. The stent-graft is fabricated from a second expandable material having a second inner diameter and a second outer diameter. In various configurations, when both the stent-graft and the cuff are in an uninflated state, a first difference between the first inner diameter and the first outer diameter is equal to a second difference between the second inner diameter and the second outer diameter, and when both the stent-graft and the cuff are in an inflated state, the first difference is greater than the second difference. In various configurations, the cuff is filled with a first pressure and an inflatable channel around the stent-graft is filled with a second pressure, the first pressure being greater than the second pressure.

[0057] The stent-graft system, in various configurations, includes a stent-graft and an anchoring mechanism. The stent-graft is configured to form a lumen when structurally supported within the blood vessel. The anchoring mechanism is configured to provide anchoring and sealing at a proximal stenosis of the blood vessel. The anchoring mechanism includes a cuff configured to continuously contact an inner wall of the proximal stenosis to provide continuous sealing and anchoring at the proximal stenosis. In various configurations, the anchoring mechanism includes a stent-like skeletal structure disposed at one end of the cuff, the opposite end of the cuff abutting a first end of the stent-graft. In various configurations, the cuff is configured to continuously contact the inner wall of the proximal stenosis from the stent-like skeletal structure to the first end of the stent-graft. In various configurations, the stent graft includes a first stent graft and a second stent graft, the first stent graft and the second stent graft overlapping to form an integrated stent graft, the first stent graft abutting opposite ends of the cuff, and the first end of the integrated stent graft being the first end of the first stent graft abutting the opposite end of the cuff.

[0058] The present technology is not intended to be limited with respect to the specific configurations described in this application, which are intended to be illustrative of aspects of the present technology. As will be apparent to those skilled in the art, many modifications and variations of the present technology can be made without departing from its spirit and scope. In addition to those enumerated herein, functionally equivalent systems and methods within the scope of the present technology will be apparent to those skilled in the art from the foregoing description. Such modifications and variations are intended to fall within the scope of the present technology. It is understood that the present technology is not limited to specific systems and methods of using such systems, which may, of course, vary. It is also understood that the terminology used herein is for the purpose of describing particular configurations only, and is not intended to be limiting. [Explanation of symbols]

[0059] 100 Stent Graft System 102 Aneurysm 106 Proximal stenosis 130 Inflatable filling structure 132 Filling media 145 Stent-like skeletal structure

Claims

1. A stent graft and an inflatable filling structure at least partially surrounding the stent graft and having a branched cavity; a cuff that is fillable and positioned externally of the inflatable filling structure; A stent graft system comprising:

2. a portion of the cavity configured to receive a branch stent graft for connection to the stent graft; The stent graft system according to claim 1 .

3. The cuff is positioned at an end of the stent graft. The stent graft system according to claim 1 .

4. the cuff has a tapered shape such that when filled with a filling medium, it is wider at one end than at the opposite end; The stent graft system according to claim 1 .

5. an inflatable channel positioned at least partially around said stent graft and surrounded by said inflatable filling structure; The stent graft system of claim 1 further comprising:

6. the cuff and the inflatable filling structure are independently inflatable with filling medium to different pressures; The stent graft system according to claim 1 .

7. the inflatable filling structure is configured such that the branched cavity is longer on one side of the branch than on the other side of the branch; The stent graft system according to claim 1 .

8. a scaffolding mechanism positioned at least partially in the cavity in an area where a branch stent graft can be inserted into the cavity; Further comprising: the skeletal mechanism is configured to provide structural support to the inflatable filling structure before the branch stent graft is received within the cavity. The stent graft system according to claim 1 .

9. a longitudinal support structure anchored to an end of the inflatable filling structure and structurally coupled to the skeletal mechanism; The stent graft system of claim 1 further comprising:

10. the stent graft comprises an integrally formed main stent graft and a branch stent graft, the main stent graft including a cavity for receiving a second branch stent graft; The stent graft system according to claim 1 .

11. 1. A method of using a stent graft system including a stent graft, an inflatable filling structure, and a cuff, comprising: filling the inflatable filling structure, the inflatable filling structure at least partially surrounding the stent graft and having a branched cavity; filling the cuff positioned outside the inflatable filling structure to form a seal with the wall of the blood vessel; A method comprising:

12. inserting a branch stent graft into the cavity of the inflatable filling structure; 12. The method of claim 11 further comprising:

13. inserting said branch stent graft at least partially within said stent graft; 13. The method of claim 12, further comprising:

14. the cuff and the inflatable filling structure are filled to different pressures; 12. The method of claim 11 .

15. the cuff is inflated to a pressure greater than the filling pressure of the inflatable filling structure; 12. The method of claim 11 .

16. the cuff is sized so that it extends from the bottom of the renal arteries to the top of the aneurysm and, when filled, forms a seal across the proximal stenotic region of the aorta; 12. The method of claim 11 .

17. filling an inflatable channel positioned at least partially around said stent graft and surrounded by said inflatable filling structure; 12. The method of claim 11 further comprising:

18. the cuff has a tapered shape so that when it is filled it is wider at one end than at the opposite end; 12. The method of claim 11 .

19. one side of the inflatable filling structure surrounding a first branch stent graft is longer than another side of the inflatable filling structure surrounding a second branch stent graft; 12. The method of claim 11 .

20. providing structural support for a portion of the cavity of the inflatable filling structure that is separate from the branch stent graft prior to inserting the branch stent graft into the portion of the cavity using a skeletal mechanism; 12. The method of claim 11 further comprising:

21. A stent graft and an inflatable filling structure at least partially surrounding the stent graft, at least one of the inflatable filling structures having at least one cavity; a cuff that is fillable and positioned externally of the inflatable filling structure; A stent graft system comprising:

22. 22. The stent graft system of claim 21, wherein the inflatable filling structure comprises a plurality of individual cavities.

23. 22. The stent graft system of claim 21, wherein the inflatable filling structure includes a branch cavity.

24. 22. The stent graft system of claim 21, wherein the inflatable filling structure includes cavities configured to provide access to multiple arteries.

25. 22. The stent graft system of claim 21, wherein the inflatable filling structure includes cavities configured for fluid communication with various arteries, such as the iliac and renal arteries.

26. 22. The stent graft system of claim 21, comprising a fenestrated stent graft.

27. 22. The stent graft system of claim 21, including branched stent grafts anchored in the iliac and renal arteries.

28. 22. The stent graft system of claim 21, comprising a plurality of inflatable filling structures.

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