Systems, devices, and methods for coupling prosthetic implant to open window

Abstract

Devices, systems, and methods for coupling a prosthetic implant to an open window are disclosed herein. In some embodiments, a branch stent graft is provided. The branch stent graft may include an engagement portion for engagement with an opening in an open window, such as a vascular wall or aortic stent graft. The engaging portion of the branch stent graft may be coupled to the open window such that the branch stent graft may be moved, rotated, or displaced relative to the open window, but such that axial movement of the branch stent graft is limited and / or prevented.

Description

[0001] This application is a divisional application of a patent application for invention, with the application date of August 1, 2017, the application number of 202110457141.6 (the original application number of the parent case is 201780061126.1, and the international application number is PCT / US2017 / 044822), and the invention title of "Systems, Devices, and Methods for Coupling a Prosthetic Implant to a Fenestrated Body".

[0002] Cross - Reference to Related Applications

[0003] This application claims the priority and benefit of U.S. Provisional Patent Application Serial No. 62 / 369,978, entitled "Systems, Devices, and Methods for Coupling a Prosthetic Implant to a Fenestrated Body", filed on August 2, 2016, the disclosure of which is hereby incorporated by reference in its entirety. Technical Field

[0004] The embodiments described herein generally relate to prosthetic implants, and more particularly, to devices and methods for engaging a prosthetic implant (such as a branched vascular stent - graft) within a window of a second prosthetic implant (such as an aortic stent - graft). Background Art

[0005] Prosthetic devices are typically implanted in a diseased portion of a patient, such as, to repair, support, stent, and / or otherwise facilitate the proper function of those diseased portions. In some cases, prosthetic devices such as stent - grafts can be used to repair diseased portions of a patient's vascular system. For example, an aneurysm within a patient's vascular system typically involves an abnormal swelling or dilation of a blood vessel (such as an artery), which typically weakens the vessel wall and makes it prone to rupture. Abdominal aortic aneurysm (AAA) is a common type of aneurysm that poses a serious threat to health. A common method for treating AAA and other types of aneurysms is to place an endovascular stent - graft within the affected blood vessel such that the stent - graft spans (e.g., traverses) and extends beyond the proximal and distal ends of the diseased portion of the vasculature. Thus, the stent - graft can re - partition the diseased vasculature, providing an alternative blood conduit that isolates the aneurysm from the high - pressure flow of blood, thereby reducing or eliminating the risk of rupture. In other cases, the prosthetic device can be an implant and / or mechanism that can provide structural or functional support for a diseased and / or defective portion of the body. However, in some cases, when attempting to place and / or secure a prosthetic device (including stent - grafts, etc.), the arrangement of the anatomical structures can pose challenges. These challenges can lead to misalignment and / or sub - optimal configuration of the prosthetic device within the anatomical structure.

[0006] Minimally invasive endovascular repair using stent grafts is generally preferred to avoid the risks associated with traditional open surgical repair. However, these stent grafts can only be used when the graft can be placed in a stable position without covering major branch vessels. In the case of an adrenal aneurysm that extends to but does not involve the renal artery, the proximal portion of the stent graft needs to be fixed to the aortic wall above the renal artery, thus blocking the opening of the renal artery. Therefore, patients with juxtarenal aneurysms, which represent a significant proportion of abdominal aortic aneurysm cases, are generally excluded from endovascular treatment.

[0007] To allow endovascular repair of a wider range of cases, surgeons sometimes cut an opening in the body of the stent graft to accommodate the origin of a specific branch vessel, a process known as "fenestration". Thus, for example, in treating juxtarenal aneurysms using a procedure called fenestrated endovascular aortic repair ("FEVAR"), the window or opening in the aortic stent graft will be aligned with the branch vessel. Then, an additional stent graft (such as a renal stent) can be placed in the branch vessel and fixed to the main stent graft (such as the aortic stent graft) to limit movement of the main stent graft within the anatomy and ensure proper blood flow. Additionally, in some cases, an endovascular stent graft can be placed within one or more specific branch vessels to further treat the aneurysm and / or strengthen the branch vessels in the aneurysm area. SUMMARY OF THE INVENTION

[0008] Devices, systems, and methods for attaching a prosthetic implant to a fenestrated body are disclosed herein. In some embodiments, a branched stent graft is provided. The branched stent graft can include a mating portion for mating with an opening in a fenestrated body (such as a vessel wall or an aortic stent graft). The mating portion of the branched stent graft can be coupled to the fenestrated body such that the branched stent graft can rotate or shift relative to the fenestrated body, but axial movement of the branched stent graft is restricted and / or prevented. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a diagram of an affected abdominal aorta according to one embodiment.

[0010] Figure 2A is a portion of a stent graft according to one embodiment and just placed within Figure 1 the affected abdominal aorta.

[0011] Figure 2B is placed within Figure 1 the affected abdominal aorta and after being left in place for a period of time Figure 2A a portion of the stent graft.

[0012] Figure 3Illustration of at least a portion of a fenestrated stent graft according to one embodiment.

[0013] Figure 4 is Figure 3 Illustration of the portion of the fenestrated stent graft that is within, for example, a portion of a diseased abdominal aorta.

[0014] Figure 5A Schematic of a front view of a fenestration body according to one embodiment.

[0015] Figures 5B - 5D Schematic side views of a system in a first configuration, a second configuration, and a third configuration, respectively, according to one embodiment.

[0016] Figure 6 Schematic cross-sectional side view of a system according to one embodiment.

[0017] Figure 7 Schematic cross-sectional side view of a system according to one embodiment.

[0018] Figure 8 Schematic cross-sectional side view of a system according to one embodiment.

[0019] Figure 9 Schematic cross-sectional side view of a system according to one embodiment.

[0020] Figure 10 Schematic cross-sectional side view of a system according to one embodiment.

[0021] Figures 11A - 11C Schematic cross-sectional side views of a system in a first configuration, a second configuration, and a third configuration, respectively, according to one embodiment.

[0022] Figure 12 Schematic cross-sectional side view of a system according to one embodiment.

[0023] Figure 13A Schematic cross-sectional side view of a system in a first configuration according to one embodiment.

[0024] Figure 13B is of Figure 13A the system in a second configuration

[0025] Figure 14 Schematic cross-sectional side view of a system according to one embodiment.

[0026] Figure 15 Schematic cross-sectional side view of a system according to one embodiment.

[0027] Figure 16A Schematic cross-sectional side view of a system in a first configuration according to one embodiment.

[0028] Figure 16B is in a second configuration Figure 16A Schematic cross-sectional side view of the system.

[0029] Figure 16C is in a third configuration Figure 16A Schematic cross-sectional side view of the system.

[0030] Figure 16D is in a fourth configuration Figure 16A Schematic cross-sectional side view of the system.

[0031] Figure 16E is in a second configuration Figure 16D Schematic view of the inner wall of the system. DETAILED DESCRIPTION

[0032] Devices, systems, and methods for attaching a prosthetic implant to a fenestrated body are disclosed herein. In some embodiments, the fenestrated body includes a flexible engagement portion. The prosthetic implant can be configured to engage the flexible engagement portion such that the prosthetic implant can rotate relative to the fenestrated body while maintaining a perpendicular angle between the longitudinal central axis of the prosthetic implant and the plane of the flexible engagement portion.

[0033] In some embodiments, a branched stent graft is provided. The branched stent graft can include an engagement portion for engaging an opening in a fenestrated body (such as a vessel wall or an aortic stent graft). The engagement portion of the branched stent graft can be coupled to the fenestrated body such that the branched stent graft can rotate or displace relative to the fenestrated body, but axial movement of the branched stent graft is restricted and / or prevented.

[0034] As used in this specification, the singular forms "a", "an", "the", and "said" or any singular or plural without modification include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "member" is intended to denote a single member or a combination of members, and the term "material" is intended to denote one or more materials or a combination thereof.

[0035] As used herein, the terms "proximal" and "distal" refer to directions that are closer to and farther from, respectively, an operator of a medical device, for example. Thus, for example, the end of a medical device that contacts a patient's body will be the distal end of the medical device, and the end opposite the distal end will be the proximal end of the medical device. Similarly, when a device such as an endovascular stent graft is disposed within a portion of a patient, the end of the device closer to the patient's heart will be the proximal end, and the end opposite the proximal end will be the distal end. In other words, the proximal end of such a device can be upstream of the distal end of the device.

[0036] The embodiments described herein may be formed or constructed from one or more biocompatible materials. Examples of suitable biocompatible materials include metals, ceramics, or polymers. Examples of suitable metals include medical grade stainless steel, gold, titanium, tungsten, nickel, iron, platinum, tin, chromium, copper, and / or their alloys. Examples of polymers include nylon, polyester, polycarbonate, polyacrylate, ethylene vinyl acetate, and other polymers of acyl-substituted cellulose acetate, non-degradable polyurethanes, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulfonated polyolefins, polyethylene oxide, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyurethanes, and / or their blends and copolymers.

[0037] The embodiments and methods described herein can be used to form patient-specific prosthetic devices and / or to facilitate the function and / or integration of a prosthetic device within a portion of a patient. For example, in some embodiments, the devices and / or methods described herein can be used in conjunction with endovascular repair using a stent graft and / or can be included in such endovascular repair. Although embodiments are shown and described herein, for example, to facilitate endovascular repair, in other embodiments, any of the devices and / or methods described herein can be used to facilitate the treatment of any portion of a patient. For example, the devices and methods described herein can form and / or can facilitate the integration of any suitable implant, prosthesis, device, mechanism, machine, etc. within a portion of a patient's body (such as the patient's vascular system, nervous system, musculoskeletal system, etc.). Thus, while some embodiments are shown and described herein for endovascular repair of abdominal aortic aneurysms, they are presented by way of example and are not limited thereto.

[0038] Some of the devices and / or methods described herein can be used in minimally invasive treatment techniques, such as endovascular repair using a stent graft. Such repair techniques are generally superior to traditional open surgical repair and generally result in reduced morbidity or mortality. However, in some cases, the arrangement of the diseased vasculature may require that a portion of the stent graft be altered prior to insertion into the body. For example, in endovascular repair of an abdominal aortic aneurysm, the aneurysm can be located adjacent to and / or directly distal to a normally functioning vessel that branches from a portion of the aorta. To resect the aneurysm with a stent graft, surgeons often cut an opening in the stent graft fabric to accommodate the origin of a specific branch vessel, a process known as "fenestration". Specifically, in the treatment of juxtarenal aneurysms and / or the treatment of other aneurysms, for example Figure 1 as shown, the window or opening in the stent graft can correspond in size, shape, and / or relative position, etc. to the renal artery, superior mesenteric artery (SMA), and / or celiac artery ( Figure 1 not shown in the illustration).

[0039] Traditionally, the fenestration process involves measurements based on medical images (such as CT scans) of the vascular origin. For example, in some cases, the longitudinal distance of the branch vessels can be measured, and the relative angular position of the branch vessels can be estimated and / or calculated based on reference points. Based on these measurements and / or calculation results, a surgeon or manufacturer can mark and cut the stent fabric of the stent graft to define one or more windows. The fenestrated stent graft is then positioned within the diseased vasculature (e.g., via endovascular surgery) and oriented such that the windows are substantially aligned with the openings of the corresponding branch vessels.

[0040] In some cases, the windows in the fenestrated body (such as a fenestrated stent graft or a vessel wall) described herein can be generated and / or otherwise formed based on medical imaging data of the diseased portion of the patient's vascular system (such as an abdominal aortic aneurysm). For example, an electronic device such as a personal computer, a workstation, or a laptop computer can receive the imaging data and can calculate and / or determine a digital representation of the imaging data. Based on this digital representation, the electronic device can determine one or more templates, process plans, instructions, data sets, etc. associated with an object (such as a stent graft) and / or indicating a desired set of window positions along the object. In some cases, the electronic device can output a map, a plan, and / or a template, which can in turn be used by a physician, a surgeon, a technician, and / or a manufacturer to form the fenestrated body (such as a fenestrated stent graft). For example, in some embodiments, such templates, etc. can be substantially similar to those described in U.S. Patent Publication No. 2013 / 0296998, entitled "Fenestration Template for Endovascular Repair of Aortic Aneurysms," filed on May 1, 2013 ("the '998 publication") and / or those described in U.S. Patent Application No. 15 / 163,255, entitled "Devices and Methods for Anatomic Mapping for Prosthetic Implants," filed on May 24, 2016 ("the '255 application"), the disclosures of which are hereby incorporated by reference in their entirety.

[0041] In other cases, a window in a fenestrated body (such as a fenestrated stent graft or a vessel wall) can be formed without such a template. For example, in some embodiments, an electronic device can output instructions and / or code (such as machine code such as G-code) to a computer numerical control (CNC) device and / or a computer-aided manufacturing (CAM) device, which in turn can perform one or more manufacturing processes associated with forming and / or otherwise marking the location of a window along a patient-specific prosthesis (such as a stent graft), etc. The formation of the patient-specific prosthesis can be performed in a manual process or in at least a partially automated process. Additionally, the devices and / or methods described in International Patent Application No. PCT / US2016 / 041355, filed on July 7, 2016, titled "Devices and Methods for Anatomic Mapping for Prosthetic Implants" ("the '355 application") can be used to determine and / or calculate changes in the arrangement of a portion of the anatomy caused by the insertion and / or retention of a prosthesis, the disclosure of which is incorporated herein by reference in its entirety.

[0042] Figures 1 - 2B A diseased portion of a patient's abdominal aorta 10 is shown. Although various portions of the abdominal aorta 10 are described below, the discussion of the abdominal aorta 10 is not exhaustive; rather, the following discussion provides a reference to the relevant anatomy. Additionally, the discussion of the anatomy (such as the abdominal aorta 10) relates to the position, orientation, etc. of such a structure relative to the patient as would not be observed by an observer (such as a doctor). For example, when referring to the left side of the patient or an anatomical structure disposed on the "left" side or near the patient, "left" is intended to describe the position as viewed from the front (such as forward) relative to the patient and / or from the patient's perspective.

[0043] The abdominal aorta 10 (also referred to herein as the "aorta") has: a proximal portion 11 that receives blood flow from the descending aorta (not shown); and a distal portion 12 that supplies blood flow to the lower extremities. As Figure 1 shown, the aorta 10 at or near the proximal portion 11 supplies blood flow to the right renal artery 13 and the left renal artery 14, which in turn supply blood to the right kidney and the left kidney (not shown), respectively. Although not shown in Figure 1 the proximal portion 11 of the aorta 10 also supplies blood flow to the superior mesenteric artery (SMA) and the celiac artery. The distal portion 12 of the aorta 10 forms the iliac bifurcation 20, through which the aorta 10 supplies blood flow to the right common iliac artery 15 and the left common iliac artery 16, which in turn supply blood to the right and left lower extremities, respectively. As Figure 1As shown, the patient has an abdominal aortic aneurysm (AAA) 17, which is located distal to the renal arteries 13 and 14 and near the iliac bifurcation 20. More specifically, the AAA 17 is positioned such that the proximal portion of the stent graft is prevented from attaching between the renal arteries 13 and 14 and the AAA 17. Thus, a fenestrated stent graft 160 (see, e.g., Figure 2A and 2B ) is used for the endovascular repair of the AAA 17.

[0044] In some cases, the endovascular repair of the AAA 17 includes scanning and / or otherwise capturing anatomical imaging data associated with the patient's aorta 10. For example, the imaging device can be an X-ray device, a computed tomography (CT) device, a computed axial tomography (CAT) device, a magnetic resonance imaging device (MRI), a magnetic resonance angiography (MRA) device, a positron emission tomography (PET) device, a single photon emission computed tomography (SPECT) device, an ultrasound device, and / or any other suitable device and / or combination thereof for imaging a portion of the patient's body (e.g., a CT / MRA device, a PET / CT device, a SPECT / CT device, etc.). Thus, the imaging data captured by the imaging device can be used to determine significant features of the patient's aorta 10, such as branch vessels in fluid communication with the aorta 10. For example, an internist, a surgeon, a technician, a manufacturer, etc. can use the imaging data to determine and / or calculate the dimensions, shape, location, and / or orientation of the aorta 10, the branch vasculature in fluid communication with the aorta 10 (e.g., the renal arteries 13 and 14), and / or any other suitable vasculature or anatomical structure. In some cases, an internist, a surgeon, a technician, a manufacturer, etc. can form and / or define one or more windows 165 in the stent graft 160 that are associated with the determined and / or calculated features of at least the renal arteries 13 and 14, as described in the '998 application, the '255 application, and / or the '355 application, which are incorporated herein by reference.

[0045] As Figure 2A shown, the stent graft 160 can be positioned within a portion of the patient's abdominal aorta 10 via an endovascular procedure. For example, the stent graft 160 can be disposed within a delivery catheter (e.g., in a folded, compressed, constrained, and / or other undeployed configuration), which is inserted, for example, into the femoral artery (not shown). The delivery catheter can be advanced through the artery and into the abdominal aorta 10. Once advanced to the desired location within the abdominal aorta 10, the delivery catheter can be withdrawn relative to the stent graft 160. As the delivery catheter is retracted and / or withdrawn, the stent graft 160 transitions from a folded configuration to an expanded or deployed configuration, thereby supporting a portion of the abdominal aorta 10.

[0046] The stent graft 160 includes a proximal portion 161 and a distal portion 162 and defines a lumen 163 therethrough. The stent graft 160 can be any suitable stent graft. For example, the stent graft 160 can be formed of, for example, those elastic biocompatible materials described above. For example, the stent graft can include a stent or frame coupled to the graft material. In some embodiments, the stent (i.e., the frame) can be constructed of a metal or metal alloy (such as nickel-titanium (nitinol)), and the graft material can be constructed of a braided polymer or fabric (such as polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET or Dacron®)). In some embodiments, the graft material or fabric can be woven onto and / or coupled to the stent in any other suitable manner to form a stent graft (such as the stent graft 160).

[0047] The stent graft 160 further includes a set of reinforcement members 164 circumferentially disposed about the stent graft 160. The reinforcement members 164 can be any suitable structure that can, for example, bias the stent graft 160 into an open configuration to structurally support the stent graft material (also referred to as the "stent fabric" or "graft fabric"). In some embodiments, the reinforcement members 164 can be formed of, for example, those metals or metal alloys described above. In some embodiments, for example, such metal or metal alloy is radiopaque and / or coated with a radiopaque material that is configured to be visible using, for example, fluoroscopy. As Figure 2A shown, the reinforcement members 164 can transition from a constrained or deformed delivery configuration (such as when disposed within a delivery catheter) to an expanded and / or biased retention configuration.

[0048] In this embodiment, as described above, the stent graft 160 defines a set of windows 165. As described herein, the location of the windows 165 along the stent graft 160 can be based on anatomical imaging data and / or one or more digital representations of the patient's anatomy. A physician, surgeon, technician, and / or manufacturer can then use the imaging data and / or digital representation to define the windows 165 in the graft fabric. As shown, in this example, the windows 165 are each aligned with their corresponding renal artery 13 or 14, and each window 165 can have a size, shape, and / or configuration associated with its corresponding renal artery 13 or 14. In this way, the windows 165 can allow blood to flow from the aorta 10 into the right renal artery 13 and the left renal artery 14 via the windows 165. Although not shown in Figure 2A the stent graft 160 can define one or more windows associated with other branch vessels (such as the superior mesenteric artery (SMA), celiac artery, etc.) originating from the aorta 10.

[0049] As Figure 2BAs shown, the placement and / or retention of the stent graft 160 within the aorta 10 can, for example, alter, displace, rotate, translate, deform, and / or otherwise reconfigure the arrangement of the patient's aorta 10. As a result, the openings of the renal arteries 13 and 14 are displaced relative to the window 165 defined by the stent graft 160. In some cases, the displacement of the aorta 10 relative to the stent graft 160 results in at least partial occlusion of the renal arteries 13 and 14, as Figure 2B shown. For example, in some cases, the openings of the renal arteries 13 and 14 can be from about 4 millimeters (mm) to about 7 mm, and the displacement and / or rearrangement of the aorta 10 can cause the openings of the renal arteries 13 and 14 to be displaced relative to the window 165 by about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, or more (or an interval less than one millimeter). Thus, although the window 165 is defined at a desired location along the stent graft 160 based on imaging data, the displacement of the aorta 10 caused by the placement and / or retention of the stent graft 160 can result in occlusion of the renal arteries 13 and 14. In some cases, the displacement of the aorta 10 can result in about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% (or any percentage or an interval of a small percentage) occlusion of the renal arteries 13 and 14. Although not shown in Figure 2A and 2B the displacement of the aorta 10 can cause a similar misalignment of any branch vessel relative to its corresponding window in the stent graft 160. In some embodiments, the electronic device can be configured to determine and / or calculate the displacement of the anatomical structure caused by the insertion and / or retention of the prosthesis (e.g., the stent graft), and can determine one or more digital representations of the displaced anatomical structure. As described in the '998 application, the '255 application, and / or the '355 application, which are incorporated herein by reference above, one or more windows can be formed in the stent graft (e.g., the stent graft 160) based on the calculated displacement.

[0050] Figure 3Shows at least a portion of a fenestrated stent graft 260 according to one embodiment. As described above, the stent graft may define one or more windows configured to accommodate one or more branch vessels when the stent graft is deployed in the aorta. Specifically, in this embodiment, the fenestrated stent graft 260 includes a proximal portion 261 and a distal portion 262, and defines a lumen 263 and a set of windows 265. The fenestrated stent graft 260 can be any suitable stent graft and / or prosthesis. For example, in some embodiments, the fenestrated stent graft 260 can be an off-the-shelf stent graft. In other embodiments, the fenestrated stent graft 260 can be a patient-specific stent graft having dimensions, shapes, and / or configurations corresponding to the patient's anatomy.

[0051] The fenestrated stent graft 260 (also referred to herein as "stent graft") can have any suitable shape, size, and / or configuration. For example, in some embodiments, the stent graft 260 can have dimensions associated with the dimensions of the lumen defined by the aorta. In other embodiments, the fenestrated stent graft 260 can have dimensions associated with the adjusted or calculated dimensions of the lumen defined by the aorta resulting from the endovascular placement of the stent graft 260. Additionally, the stent graft 260 can have any suitable mechanical properties, such as strength, stiffness, etc.

[0052] As Figure 3 shown, in some embodiments, the stent graft 260 can include a stent 264 and a graft fabric 266. The stent 264 can be, for example, any suitable stent and / or frame configured to increase the stiffness of the stent graft 260 and / or provide structural support for the stent graft 260. As described above, the stent 264 can be formed of any suitable metal or metal alloy (such as nitinol). In some embodiments, the stent 264 can be configured to transition between a first expanded and / or implanted configuration and a second folded and / or delivery configuration. Additionally, in some cases, the stent 264 can be biased such that the stent 264 is in the first configuration until a force is applied to the stent 264 to transition it from the first configuration to the second configuration (such as when placed in a delivery sheath, etc.).

[0053] The graft fabric 266 can be formed of any suitable polymer or fabric (such as Dacron®, etc.). In some embodiments, the graft fabric 266 can be woven around and / or through the stent 264. In other embodiments, the graft fabric 266 can be attached to the stent 264 by sutures, friction fit, or adhesives, and / or can encapsulate the stent 264 between at least two layers of graft fabric 266. As Figure 3As shown, the graft fabric 266 defines a window 265, and the window 265 can be arranged relative to the stent 264 such that the window 265 does not overlap the stent 264. In other words, the window 265 can be arranged along the stent graft 260 such that one or more portions of the stent 264 do not span and / or otherwise pass through the window 265. In other embodiments, one or more portions of the stent 264 can span and / or otherwise cross the window 265. Additionally, as described in detail above, the window 265 can be defined by the graft fabric 266 at a location along the stent graft 260 based on a digital representation of an updated, projected, anticipated, and / or otherwise calculated portion of the patient's vasculature.

[0054] As described above, the stent graft 260 can be any suitable stent graft and can be formed by any suitable manufacturing process. In some embodiments, the stent graft 260 can be manufactured as an off-the-shelf stent graft, and the window 265 can be formed in the graft material 266 during a subsequent manufacturing process. In other embodiments, the stent graft 260 can be manufactured as a "custom" or non-off-the-shelf stent graft. Although specific manufacturing methods are described herein, it should be understood that these methods are presented by way of example only and not limitation. Additionally, the manufacturing methods described herein can be performed in a single facility and / or a single manufacturing process, or can be performed in multiple facilities and / or multiple manufacturing processes. In some cases, various portions of the manufacturing methods described herein can be performed by an end user (e.g., a physician, surgeon, technician, nurse, etc.). Thus, although the manufacture of the stent graft 260 is specifically described below, the stent graft 260 can be formed by any suitable manufacturing process and is not limited to those discussed herein.

[0055] In some cases, based on, for example, the results of calculations of the patient's anatomical imaging data, a stent graft 260 can be manufactured having a general shape, diameter, length, etc. associated with the patient's aorta. In other embodiments, the stent graft 260 can have a general shape, size, and / or configuration associated with an updated model determined by an electronic device, which in turn corresponds to a calculated, projected, and / or modified arrangement of the aorta in response to, for example, the insertion and retention of the stent graft 260 as described in detail above. Thus, the stent graft 260 generally has a tubular or cylindrical shape. In some embodiments, the diameter of the lumen 263 is at least partially based on the diameter of the calculated, projected, and / or modified lumen defined by the aorta. Additionally, the stent graft 260 can have a rigid and / or any other suitable mechanical property associated with the anticipated amount and / or method of aortic displacement caused by the insertion and / or retention of the stent graft 260 as described in the '998 application, the '255 application, and / or the '355 application, which are incorporated herein by reference.

[0056] Windows 265 can be defined along the stent graft 260 such that each window 265 corresponds to the location of the calculated site of a respective branch vasculature (e.g., renal artery), and each window 265 can be formed in any suitable manner as described in the '998 application, the '255 application, and / or the '355 application, which are incorporated herein by reference.

[0057] As Figure 4 shown, when defining the windows 265 along the stent graft 260, the stent graft 260 can be positioned within a portion of the patient's body using any suitable endovascular procedure. In this embodiment, the stent graft 260 is positioned within the aorta 10 of the patient. As shown, the stent graft 260 can include, for example, a first set of windows 265A that are associated with and / or otherwise correspond to the right renal artery 13 and the left renal artery 14. Specifically, each window 265A is aligned with its corresponding renal artery 13 or 14, and each window 265A can have dimensions, a shape, and / or a configuration associated with its corresponding renal artery 13 or 14. In some embodiments, the dimensions, shape, and / or position of the window 265A are associated with and / or substantially correspond to the adjusted and / or calculated dimensions, shape, and / or position of its corresponding renal arteries 13 and 14. For example, placing the stent graft 260 within the aorta 10 can, for example, alter, displace, rotate, translate, deform, and / or otherwise reconfigure the arrangement of the patient's aorta 10. Thus, by offsetting the stent graft 260 from the updated model, the dimensions, shape, and / or position of the windows 265 defined by the stent graft 260 can be made to correspond to the desired branch vasculature (e.g., the right renal artery 13 and / or the left renal artery 14). In addition to positioning the stent graft 260 within a portion of the patient's aorta 10, the renal arteries 13 and / or 14 can also be stented, for example, through the windows 265A ( Figure 4 not shown in). Stenting of the renal arteries can be performed with auxiliary branch stents ( Figure 4 not shown in), which engage the fenestrated body of the stent graft 260 at the windows 265A and extend within branch arteries such as the renal arteries 13 and / or 14. In this way, the windows 265A on the stent graft 260 and the auxiliary branch stents (not shown) positioned to correspond to the branch arteries can assist in the axial and / or radial alignment and positioning of the stent graft 260 during deployment. In addition, the windows 265A and the auxiliary branch stents (not shown) can also help to maintain the alignment and positioning of the stent graft 260 relative to the patient's aorta 10 after placement.

[0058] As Figure 3 and 4As shown, in some embodiments, the stent graft 260 may include a second set of windows 265B that are associated with and / or otherwise correspond to other branch vessels that would otherwise be blocked by the non-windowed portion of the stent graft 260. For example, the windows 265B may be associated with and / or correspond to the superior mesenteric artery (SMA) 18 and the celiac artery 19, respectively. In other embodiments, the stent graft 260 may define windows to accommodate more or fewer branch vessels than those illustrated herein. For example, in some embodiments, the stent graft 260 may define windows to accommodate the inferior mesenteric artery (IMA), the internal iliac artery, and / or the like. Thus, the windows 265 defined by the stent graft 260 may allow blood to flow from the aorta 10 to the branch vasculature that would otherwise be blocked by the stent graft 260 material.

[0059] In some embodiments, the arrangement of the stent graft 260 and / or the patient's aorta may be such that the windows 265 are partially defined by the stent graft 260. For example, as shown, the most proximal window 265B is disposed at the proximal end of the stent graft 260 and corresponds to the celiac artery 19 that is partially covered by the graft material during deployment. Thus, the window 265B of the celiac artery 19 is partially circular or U-shaped to accommodate the otherwise blocked portion of the celiac artery 19. In other embodiments, any of the windows 265 may have a non-circular and / or irregular shape.

[0060] In some embodiments, the windows 265 may be marked to facilitate the positioning of the windows 265 during deployment of the stent graft 260 and to facilitate the coupling of branch stents (not shown) to the stent graft 260. For example, the peripheral edges 267A or 267B of the stent graft 260 that define the windows 265A or 265B may be stitched using gold wire and / or wire of other radiopaque materials. Similarly, the location of the windows 265 may be marked by one or more radiopaque markers. Such radiopaque wire or markers may facilitate fluoroscopic visualization of the windows 265 during endovascular repair procedures and allow the physician to position the windows 265 relative to the corresponding branch vessels. In other embodiments, any suitable material that increases visibility when using any suitable imaging device (e.g., MRI scan, CAT scan, PET scan, X-ray scan, ultrasound device, etc.) may be used to stitch and / or otherwise mark the windows 265. These markers may be placed and / or stitched using any suitable manufacturing process, which may be combined with or separate from the formation of the windows 265.

[0061] As described above, in some embodiments, the auxiliary branch stent may be coupled within a window (e.g., window 265) of a stent graft (e.g., stent graft 260). During deployment, the relative position of the auxiliary branch stent may assist in the axial and radial alignment and / or positioning of the stent graft 260 relative to the patient's aorta 10. During placement of the stent graft, the auxiliary stent may be disposed within a branch vessel (e.g., SMA 18) extending from the patient's aorta such that the auxiliary stent may help reinforce the branch vessel in an open position. Additionally, the auxiliary stent may help maintain the axial and / or radial positioning of the stent graft relative to the patient's aorta (e.g., aorta 10) after placement. The auxiliary stent may move within and / or relative to the window such that branch vessel movement can be accommodated (i.e., vascular tortuosity can be compensated for and vascular kinking can be prevented). In some embodiments, the fenestrated body (e.g., the main stent graft) may include a flexible portion surrounding the window such that a rigid branch stent engaged with the fenestrated body at the window may rotate within the window. For example, Figure 5A is a schematic front view of a fenestrated body 460. The fenestrated body 460 may be, for example, a main stent graft such as an aortic stent graft. The fenestrated body 460 may have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (e.g., stent graft 160 or stent graft 260). The fenestrated body 460 may define a window 465 and include an engagement portion 468 surrounding the window 465. The engagement portion 468 may be flexible and may be configured to engage with a branch stent graft 430 (as Figures 5B - 5D shown). The branch stent graft 430 may be any suitable stent, such as a bridging stent or a FEVAR stent.

[0062] Figures 5B - 5D are schematic side views of a system 400 in first, second, and third configurations, respectively. The system 400 includes a fenestrated body 460 and a branch stent graft 430. The branch stent graft 430 may be rigid or flexible. The engagement portion 468 may be configured such that when the branch stent graft 430 moves relative to the fenestrated body 460 through the Figures 5B - 5D configurations shown, the plane or surface of the engagement portion 468 remains perpendicular to the longitudinal central axis of the branch stent graft 430. As Figure 5B shown, the branch stent graft 430 may be positioned in a first configuration in which the longitudinal central axis of the branch stent graft 430 is perpendicular to the wall of the fenestrated body 460. As Figure 5C shown, the branch stent graft 430 may be displaced to a second position (i.e., a second configuration) relative to the branch stent graft 430. As Figure 5D shown, the branch stent graft 430 may be displaced to a third position (i.e., a third configuration) relative to the branch stent graft 430. Although the system 400 is shown inFigures 5B - 5D For purposes of illustration, three configurations are shown, but system 400 can essentially have an infinite number of configurations. In other words, the junction portion 468 is flexible enough to allow the longitudinal central axis of the branched stent graft 460 to remain aligned with the branched blood vessel, regardless of the movement of the fenestrated body 460.

[0063] In some embodiments, the junction portion 468 can include a flexible locking mechanism (not shown). The flexible locking mechanism can be configured to engage the branched stent graft 430 and maintain the engagement between the flexible locking mechanism and the branched stent graft 430 through various positions of the stent graft 430. The flexible locking mechanism can also limit and / or prevent axial movement of the branched stent graft 430 within and / or relative to the window 465 of the fenestrated body 460.

[0064] In some embodiments, instead of the fenestrated body including a flexible junction portion, the junction portion of the fenestrated body can be rigid and the associated branched stent graft can be flexible. For example, Figure 6 is a schematic cross-sectional side view of a system 500 that includes a fenestrated body 560 and a flexible branched stent graft 530. The branched stent graft 530 can be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 560 can be, for example, a main stent graft such as an aortic stent graft. The fenestrated body 560 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (e.g., stent graft 160 or stent graft 260). The fenestrated body 560 can define a window 565 and include a rigid junction portion 568 surrounding the window 565. The junction portion 568 can be substantially similar to those described in International Patent Application No. PCT / US2017 / 037157, filed on June 13, 2017, titled "Systems, Devices, and Methods for Marking and / or Reinforcing Fenestrations in Prosthetic Implants" ("the '157 application"), the disclosure of which is incorporated herein by reference in its entirety.

[0065] The flexible branched stent graft 530 may include a proximal end 535 and a distal end 537. The rigid engagement portion 568 may be fixedly coupled to the proximal end 535 of the flexible branched stent graft 530. Due to the flexibility of the branched stent graft 530, the distal end 537 of the flexible branched stent graft 530 may move freely. Factors that may affect the flexibility of the branched stent graft 530 may include, for example, the stent pattern, the thickness of the stent material, the type of stent material, and / or the type of connection between the branched stent graft 530 and another stent. The flexible branched stent graft 530 may be displaced from a first position to a second position, denoted by the flexible branched stent graft 530'. In this second position, the proximal end 535 of the flexible branched stent graft 530 remains fixedly coupled to the rigid engagement portion 568. However, the distal end 537' is disposed in the second position relative to the second end 537, and the flexible branched stent graft 530' is bent into a different shape than when in the first position. Due to the secure attachment between the proximal end 535 of the flexible branched stent graft 530 and the rigid engagement portion 568, the flexible branched stent graft 530 cannot move axially relative to the window 565 and the fenestrated body 560. The secure connection between the proximal end 535 of the flexible branched stent graft 530 and the rigid engagement portion 568 may be achieved by any suitable connection structure. For example, the flexible branched stent graft 530 may include a ring having a flange at the proximal end 535.

[0066] The flange may be arranged to be adjacent to a portion of the rigid engagement portion 568 facing the interior of the fenestrated body 560. In other embodiments, the proximal end 535 of the flexible branched stent graft 530 and the rigid engagement portion 568 may be joined via a saddle feature (such as the saddle engagement portion 1031 described below).

[0067] In some embodiments, any suitable flexible branched stent graft may be configured to be fixedly coupled to the engagement portion of the fenestrated body. For example, Figure 7 is a schematic cross-sectional side view of a system 600 that includes a branched stent graft 630 and a fenestrated body 660. The branched stent graft 630 may be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 660 may be, for example, a main stent graft such as an aortic stent graft. The fenestrated body 660 may have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (such as the stent graft 160 or the stent graft 260). The fenestrated body 660 may define a window 665 and include an engagement portion 668 surrounding the window 665. The engagement portion 668 may be rigid or flexible and may be configured to be fixedly coupled to the branched stent graft 630.

[0068] The branched stent graft 630 includes a first rigid stent portion 632 and a second rigid stent portion 634. The first rigid stent portion 632 and the second rigid stent portion 634 are coupled by a flexible stent portion 636. In other words, the flexible branched stent graft 630 can be formed as an integral stent having a constant cylindrical outer diameter and can include portions having different flexibilities or rigidities. Due to the flexibility of the flexible stent portion 636, the branched stent graft 630 can bend and / or rotate relative to the engagement portion 668. For example, the branched stent graft 630 can be bent from a first position (where the central axis of the branched stent graft 630 is perpendicular to the plane or surface of the engagement portion 668) to a second position represented by the branched stent graft 630' (where the branched stent graft 630' has a bent central axis). As shown, the second rigid stent portion 634' can be displaced to the second position while the first rigid stent portion 632' remains firmly coupled to the engagement portion 668 and is immovable relative to the engagement portion 668. Additionally, the firm engagement between the first rigid stent portion 632' and the engagement portion 668 can prevent axial movement of the branched stent graft 630 relative to the fenestrated body 660.

[0069] In some embodiments, the first flexible stent portion and the second flexible stent portion can be coupled by a rigid stent portion. For example, Figure 8 is a schematic cross-sectional side view of a system 1200 that includes a branched stent graft 1230 and a fenestrated body 1260. The branched stent graft 1230 can be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 1260 can be, for example, a main stent graft such as an aortic stent graft. The fenestrated body 1260 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (such as the stent graft 160 or the stent graft 260). The fenestrated body 1260 can define a window 1265 and include an engagement portion 1268 surrounding the window 1265. The engagement portion 1268 can be rigid or flexible and can be configured to firmly couple to the branched stent graft 1230.

[0070] The branched stent graft 1230 includes a first flexible stent portion 1232 and a second flexible stent portion 1234. The first flexible stent portion 1232 and the second flexible stent portion 1234 are coupled by a rigid stent portion 1236. In other words, the branched stent graft 1230 can be formed as an integral stent having a constant cylindrical outer diameter and can include portions having different flexibilities or rigidities. Due to the flexibility of the first flexible stent portion 1232 and the second flexible stent portion 1234, the branched stent graft 1230 can bend and / or rotate relative to the engagement portion 1268. For example, the branched stent graft 1230 can bend from a first position (where the central axis of the branched stent graft 1230 is perpendicular to the plane or surface of the engagement portion 1268) to a second position represented by the branched stent graft 1230' (where the branched stent graft 1230' has a varying central axis (i.e., the central axes of the first flexible stent portion 1232 and the second flexible stent portion 1234 are curved)). As shown, the first flexible stent portion 1232' and the second flexible stent portion 1234' can be displaced to the second position, where each has a second shape, while the rigid stent portion 1236' remains the same shape in the second position. Additionally, a secure engagement between the first flexible stent portion 1232' and the engagement portion 1268 can prevent axial movement of the branched stent graft 1230 relative to the fenestrated body 1260.

[0071] In some embodiments, the branched stent graft can include two rigid portions coupled by a flexible tether. For example, Figure 9 is a schematic cross-sectional side view of a system 700 that includes a flexible branched stent graft 730 and a fenestrated body 760. The branched stent graft 730 can be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 760 can be, for example, a main stent graft such as an aortic stent graft. The fenestrated body 760 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (e.g., stent graft 160 or stent graft 260). The fenestrated body 760 can define a window 765 and include an engagement portion 768 surrounding the window 765. The engagement portion 768 can be rigid or flexible and can be configured to securely couple to the branched stent graft 730.

[0072] The flexible branched stent graft 730 includes a first rigid stent portion 732 and a second rigid stent portion 734. The first rigid stent portion 732 and the second rigid stent portion 734 are coupled by a flexible rod-shaped tether 736. The first rigid stent portion 732 and the second rigid stent portion 734 may have the same or different sizes, lengths, and / or shapes. Due to the flexibility of the tether 736, the flexible branched stent graft 730 can bend and / or rotate relative to the engagement portion 768. For example, the flexible branched stent graft 730 can bend from a first position (where the central axis of the flexible branched stent graft 730 (i.e., the central axis passing through the first rigid stent portion 732 and the second rigid stent portion 734) is perpendicular to the plane of the engagement portion 768) to a second position represented by the flexible branched stent graft 730' (where the tether 736' is bent). As Figure 9 shown, the second rigid stent portion 734' can be displaced to the second position while the first rigid stent portion 732' remains firmly coupled to the engagement portion 768 and is immovable relative to the engagement portion 768. Additionally, the firm engagement between the first rigid stent portion 732 and the engagement portion 768 can prevent axial movement of the branched stent graft 730 relative to the fenestrated body 760.

[0073] In some embodiments, the branched stent graft may include a rigid portion and a flexible tail. For example, Figure 10 is a schematic cross-sectional side view of a system 800 that includes a branched stent graft 830 and a fenestrated body 860. The branched stent graft 830 can be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 860 can be, for example, a main stent graft such as an aortic stent graft. The fenestrated body 860 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (e.g., stent graft 160 or stent graft 260). The fenestrated body 860 can define a window 865 and include an engagement portion 868 surrounding the window 865. The engagement portion 868 can be rigid or flexible and can be configured to couple to the branched stent graft 830.

[0074] The flexible bifurcated stent graft 830 includes a rigid stent portion 832, a flexible tail 836, and a flexible transition portion 833 that connects the rigid stent portion 832 and the flexible tail 836. The flexible transition portion 833 can be less flexible than the flexible tail 836 such that the flexible transition portion 833 can provide strain relief between the rigid stent portion 832 and the flexible tail 836, thereby preventing kink points or structural fatigue between the rigid stent portion 832 and the flexible tail 836. Due to the flexibility of the flexible tail 836 and the flexible transition portion 833, the flexible tail 836 can bend and / or rotate relative to the rigid stent portion 832 and the engagement portion 868. For example, the flexible tail 836 can bend from a first position (where the central axis of the bifurcated stent graft 830 (i.e., the central axis passing through the rigid stent portion 832, the flexible transition portion 833, and the flexible tail 836) is perpendicular to the plane of the engagement portion 868) to a second position represented by the bifurcated stent graft 830' (where the flexible tail 836' is bent). As shown, due to the flexibility of the flexible transition portion 833 and the flexible tail 836', the flexible tail 836' can be displaced to the second position while the first rigid stent portion 832' remains firmly coupled to the engagement portion 868 and is immovable relative to the engagement portion 868. The flexible tail 836' can be formed of any suitable material such as a metal or metal alloy (such as nitinol (nickel-titanium alloy), stainless steel, or cobalt-chromium alloy) and / or a braided polymer or fabric (such as polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET or Dacron ® ))). Additionally, the secure engagement between the rigid stent portion 832 and the engagement portion 868 can prevent axial movement of the bifurcated stent graft 830 relative to the fenestrated body 860.

[0075] In some embodiments, the bifurcated stent graft can be configured to engage movably with the engagement portion of the fenestrated body. For example, in some embodiments, both the engagement portion of the fenestrated body and the engagement portion of the bifurcated stent graft can be rigid. The engagement portion of the fenestrated body and the engagement portion of the bifurcated stent graft can engage and / or interlock such that the bifurcated stent graft can move and / or rotate relative to the fenestrated body. For example, Figures 11A - 11CFIG. 0 is a schematic cross-sectional side view of a system 900 that includes a branched stent graft 930 and a fenestrated body 960. The branched stent graft 930 can be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 960 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. The fenestrated body 960 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (such as stent graft 160 or stent graft 260). The fenestrated body 960 can define a window 965 and include a rigid engagement portion 968 surrounding the window 965. The rigid engagement portion 968 can be configured to couple to the branched stent graft 930. In some embodiments, the rigid engagement portion 968 includes reinforcement and / or marked edges of the wall of the fenestrated body 960 in the area around the window 965. In other embodiments, the rigid engagement portion 968 includes the wall of the fenestrated body 960 in the area around the window 965 but is not reinforced.

[0076] The branched stent graft 930 can include an engagement portion (not shown) that is configured to movably couple the branched stent graft 930 to the engagement portion 968 of the fenestrated body 960. Since the engagement portion of the branched stent graft 930 is movably coupled to the engagement portion 968 of the fenestrated body 960, the branched stent graft 930 can move, pivot, and / or rotate relative to the fenestrated body 960, as Figures 11A - 11C shown. Specifically, as Figure 11A shown, the branched stent graft 930 can be configured in a first position relative to the fenestrated body 960 such that the central axis of the branched stent graft 930 is perpendicular to the central axis of the fenestrated body 960. The branched stent graft 930 can be moved relative to the fenestrated body 960 such that the branched stent graft 930 is in a second position relative to the fenestrated body 960, as Figure 11B shown. The branched stent graft 930 can be displaced relative to the fenestrated body 960 to a third position relative to the main stent graft 960, as Figure 11C shown. Additionally, the engagement between the engagement portion of the branched stent graft 930 and the engagement portion 968 of the fenestrated body 960 can limit or prevent axial movement of the branched stent graft 930 relative to the fenestrated body 960.

[0077] In some embodiments, the engagement portion of the branched stent graft can be formed in any suitable shape. For example, Figure 12is a schematic cross-sectional side view of system 1000, which includes branch stent graft 1030 and fenestrated body 1060. Branch stent graft 1030 can be any suitable stent, such as a bridging stent or a FEVAR stent. Fenestrated body 1060 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. Fenestrated body 1060 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (such as stent graft 160 or stent graft 260). Fenestrated body 1060 can define window 1065 and include a junction portion 1068 surrounding window 1065. Junction portion 1068 can be configured to be coupled to branch stent graft 1030. In some embodiments, junction portion 1068 includes a reinforced and / or marked edge of the wall of fenestrated body 1060 in the area surrounding window 1065. In other embodiments, junction portion 1068 includes the wall of fenestrated body 1060 in the area surrounding window 1065 and is not reinforced.

[0078] Branch stent graft 1030 can include a saddle-shaped junction portion 1031. Saddle-shaped junction portion 1031 is configured to be movably coupled to junction portion 1068 of fenestrated body 1060. In some embodiments, branch stent graft 1030 can be self-expanding. For example, saddle-shaped junction portion 1031 can be collapsible and have a biased expansion shape such that branch stent graft 1030 can be folded for delivery and insertion through window 1065. When positioned within window 1065 such that saddle-shaped junction portion 1031 is aligned with junction portion 1068 of fenestrated body 1060, saddle-shaped junction portion 1031 can be deployed such that saddle-shaped junction portion 1031 automatically assumes an expanded configuration and engages junction portion 1068 of fenestrated body 1060, as Figure 12 shown.

[0079] In other embodiments, the junction portion 1031 or the entire branched stent graft 1030 may be moldable and radially expandable. After the branched stent graft 1030 has been delivered to the target location relative to the junction portion 1068 of the fenestrated body 1060, a separate expandable member (such as a balloon) may be used to expand and / or shape the branched stent graft 1030. The expandable member may expand such that the junction portion 1031 of the branched stent graft 1030 is shaped by the force applied to the inner surface of the junction portion 1031 by the expandable member. In some embodiments, the expandable member may be preformed such that the unconstrained expansion shape of the expandable member includes two larger diameter portions separated by a smaller diameter portion (such as an hourglass shape). The preformed expandable member may apply pressure to the inner surface of the junction portion 1031 such that the junction portion 1031 adopts a similar shape. In other embodiments, the expandable member may have an unconstrained cylindrical expansion shape, and the expansion of the expandable member may be restricted by the junction portion 1068 of the fenestrated body 1060 such that the expandable member can only expand on either side of the junction portion 1068. As a result, the expandable member can only apply an expansion force to the inner surface of the junction portion 1031 on either side of the junction portion 1068, causing the junction portion 1031 of the branched stent graft 1030 to be shaped as shown in Figure 12 shown. The expandable member may be compliant or non-compliant.

[0080] In some embodiments, the system 1000 may include stop features such that a user can determine when the junction portion 1031 of the branched stent graft 1030 and the junction portion 1068 of the fenestrated body 1060 are properly aligned for deployment and / or expansion of the junction portion 1031. The stop features may be located on the delivery device for delivering the branched stent graft 1030, on the junction portion 1068, and / or on the junction portion 1031. In some embodiments, the stop features may be located on an expandable member (such as a balloon) used to expand and / or shape the branched stent graft 1030. For example, when the expandable member is in a first expansion configuration, the stop feature may engage an anatomical feature (such as the aortic wall) to warn the user that the expandable member is properly positioned. The expandable member may then be moved to a second expansion configuration to apply pressure to the inner surface of the junction portion 1031 such that the junction portion 1031 is forced into the desired shape. In some embodiments, radiopaque markers (such as strips) may be provided on the branched stent graft 1030 and / or the junction portion 1068 such that the relative positions of the branched stent graft 1030 and the junction portion 1068 can be visually confirmed prior to deployment and / or expansion of the junction portion 1031.

[0081] When the saddle-shaped engagement portion 1031 engages the engagement portion 1068 of the fenestrated body 1060, the branched stent graft 1030 can pivot or rotate relative to the engagement portion 1068 of the fenestrated body 1060. The saddle-shaped engagement portion 1031 can include a flared distal end to limit or prevent axial movement of the branched stent graft 1030 relative to the fenestrated body 1060 while still allowing movement (e.g., pivoting, rotation, etc.) relative to the fenestrated body 1060.

[0082] In some embodiments, the saddle-shaped engagement portion of the branched stent graft can have any suitable shape. For example, Figure 13A is a schematic cross-sectional side view of a system 1100 that includes a branched stent graft 1130 and a fenestrated body 1160. The branched stent graft 1130 can be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 1160 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. The fenestrated body 1160 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (e.g., stent graft 160 or stent graft 260). The fenestrated body 1160 can define a window 1165 and include an engagement portion 1168 surrounding the window 1165. The engagement portion 1168 can be configured to couple to the branched stent graft 1130. In some embodiments, the engagement portion 1168 includes a reinforced and / or marked edge of the wall of the fenestrated body 1160 in the region surrounding the window 1165. In other embodiments, the engagement portion 1168 includes the wall of the fenestrated body 1160 in the region surrounding the window 1165 but is not reinforced.

[0083] The branched stent graft 1130 can include a saddle-shaped or hourglass-shaped engagement portion 1131. The saddle-shaped engagement portion 1031 is configured to rotatably couple to the engagement portion 1168 of the fenestrated body 1160. In such a configuration, the branched stent graft 1130 can move relative to the engagement portion 1168 of the fenestrated body 1160.

[0084] In some embodiments, the engagement portion 1131 can be moldable, and an expandable member can be used to shape the engagement portion 1131. As Figure 13AAs shown, system 1100 may include an expandable member 1140. The expandable member 1140 may be fluidly coupled to a fluid supply mechanism (not shown) that may be controlled during deployment. After the engagement portion 1131 is positioned within the window 1165, the expandable member 1140 may be inserted into the window 1165 and aligned with the engagement portion 1131 of the branched stent graft 1130 and the engagement portion 1168 of the fenestrated body 1160. Then, the expandable member 1140 may be expanded, for example, by using a fluid supply mechanism coupled to the expandable member, such that the engagement portion 1131 of the branched stent graft 1130 is shaped by the force applied to the inner surface of the engagement portion 1131 via the expandable member 1140.

[0085] In some embodiments, the expandable member 1140 may be preformed such that the unconstrained expansion shape of the expandable member 1140 includes a first portion adjacent to the fenestrated body 1160 and a second portion 1144 remote from the fenestrated body 1160. The proximal portion also includes a first large diameter portion 1141, a second smaller diameter portion 1142 remote from the first large diameter portion 1141, and a third larger diameter portion 1143 remote from the second smaller diameter portion 1142, as Figure 13A shown. The first, second, and third diameter portions of the first proximal portion form a saddle or hourglass shape of the expandable member 1140. The first diameter of the portion 1141 may be equal to, slightly larger than, or slightly smaller than the diameter of the third diameter of the portion 1143. The second small diameter portion 1142 forms a valley that engages the engagement portion 1168 of the fenestrated body 1160.

[0086] The distal portion 1144 of the expandable member 1140 may be configured to have a smaller diameter than the proximal portion that includes the saddle shape. Additionally, the distal portion 1140 may be configured to engage the tail 1136 of the branched stent graft 1130 by applying an expansion force to the inside of the branched stent graft when expanded. Thus, the preformed distal portion 1144 of the expandable member 1140 may cause the tail 1136 of the branched stent graft 1130 to adopt a desired shape. Similarly, the proximal portion of the expandable member 1140 may apply an expansion force to the inside of the proximal region of the branched stent graft 1130 such that the branched stent graft assumes a desired shape.

[0087] The proximal portion of the expandable member 1140 (including the first diameter portion 1141, the second diameter portion 1142, and the third diameter portion 1143) and the distal portion 1144 of the expandable member 1140 may be fluidly coupled to a single fluid supply mechanism or separately coupled to different fluid supply mechanisms to control their expansion during deployment. The preformed expandable member 1140 may be used to apply pressure to the inner surface of the engagement portion 1131 such that the engagement portion 1131 adopts a similar shape.

[0088] In some embodiments, the expandable member 1140 can be semi-compliant. In some embodiments, the proximal portion of the expandable member 1140 (including the first diameter portion 1141, the second diameter portion 1142, and the third diameter portion 1143 that form a saddle) can be semi-compliant, while the distal portion of the expandable member 1140 can be non-compliant. In some embodiments, both the proximal portion and the distal portion can be compliant, with the proximal portion having greater compliance than the distal portion of the expandable member 1140. In some embodiments, the distal portion can have compliance substantially equivalent to or greater than that of the proximal portion of the expandable member 1140.

[0089] As described above, rather than including a flared proximal end as in Figure 12 the saddle engagement portion 1031 shown, the saddle engagement portion 1131 can include two larger diameter portions connected by a smaller diameter valley when expanded. The engagement portion 1168 of the fenestrated body 1160 can engage the valley such that the two larger diameter portions prevent the branched stent graft 1130 from moving axially away from the main stent graft 1160, while still allowing rotational movement relative to the main stent graft 1160.

[0090] In some embodiments, the saddle engagement portion 1131 when expanded can be shaped such that the third diameter portion has a greater diameter than the first diameter portion, and both the first and third portions have a greater diameter than the second portion that forms the valley for engagement with the fenestrated body 1160. In some other embodiments, the third diameter portion can have a smaller diameter than the first portion and a greater diameter than the second valley, which second valley is still configured to engage the fenestrated body 1160 when expanded and prevent axial movement of the branched stent graft 1130.

[0091] In some other embodiments, the first and third portions of the saddle engagement portion 1131 can have substantially equal diameters when fully expanded, while the second portion has a smaller diameter and engages the fenestrated body 1160 to prevent axial movement of the branched stent graft 1130, while allowing the branched stent graft to pivot or rotate about the fenestrated body 1160.

[0092] In some embodiments, the saddle engagement portion of the branched stent graft 1130 and the engagement portion 1168 of the fenestrated body 1160 may be configured such that, upon deployment, the distal portion of the branched stent 1130 (including, for example, the third diameter portion of the saddle engagement portion 1131) is disposed outside the fenestrated body 1160, while the proximal portion of the branched stent (including, for example, the first diameter portion of the saddle engagement portion 1131) is disposed inside the fenestrated body 1160. Additionally, the intermediate portion (e.g., the second diameter portion of the saddle engagement portion 1131 that forms the valley) may be configured to frictionally engage or engage by interference fit with an opening or window in the engagement portion of the fenestrated body 1160.

[0093] In some embodiments, rather than using an expandable member, the saddle engagement portion 1131 may be collapsible and have a biased expansion shape such that the branched stent graft 1130 can be folded for delivery and insertion through the window 1165. When the saddle engagement portion 1131 is positioned within the window 1165 such that the saddle engagement portion 1131 is aligned with the engagement portion 1168 of the fenestrated body 1160, the saddle engagement portion 1131 may be deployed such that the saddle engagement portion 1131 assumes an expanded configuration (e.g., the configuration shown in Figure 13B and engages the engagement portion 1168 of the fenestrated body 1160.

[0094] In some embodiments, the system 1100 may include a stop feature such that a user can determine when the engagement portion 1131 of the branched stent graft 1130 and the engagement portion 1168 of the fenestrated body 1160 are properly aligned for deployment and / or expansion of the engagement portion 1131. The stop feature may be located on the delivery device for delivering the branched stent graft 1130, on the engagement portion 1168, and / or on the engagement portion 1131. In some embodiments, the stop feature may be located on the expandable member 1140. For example, when the expandable member 1140 is in a first expanded configuration, the stop feature may engage an anatomical feature (e.g., the aortic wall) such that the user is warned that the expandable member 1140 is properly positioned. The expandable member 1140 may then be moved to a second expanded configuration to apply pressure to the inner surface of the engagement portion 1131 such that the engagement portion 1131 is forced into the desired shape. In some embodiments, a radiopaque marker (e.g., a strip) may be disposed on the branched stent graft 1130 and / or the engagement portion 1168 such that the relative positions of the branched stent graft 1130 and the engagement portion 1168 can be visually confirmed prior to deployment and / or expansion of the engagement portion 1131.

[0095] As described above, Figure 14 the system 1300 in Figure 6the system 500 shown in, or Figure 7 the system 600 shown in, or Figure 10 the system 800 shown in. As an example, the branched stent graft 1130 can be substantially similar to the branched stent 630, and the fenestrated body 1160 can be substantially similar to the fenestrated body 660. Additionally, the engagement portion 1131 of the branched stent 1130 can be of a suitable rigidity or flexibility to engage the fenestrated body 1160 at the engagement portion 1168. The engagement portion 1131 of the branched stent 1130 can include a transition portion 1133 and a distal tail 1136 that defines a longitudinal central axis. Additionally, the branched stent 1130 can be of a suitable flexibility or rigidity to couple with the fenestrated body 1160 and maintain the longitudinal central axis substantially perpendicular to the plane defined by the opening in the fenestrated body 1160.

[0096] In some embodiments, the branched stent 1130 can include a tail 1136 that is configured to have a flexibility greater than that of the engagement portion. For example, the flexibility of the tail can be 25% greater than the flexibility of the engagement portion 1131 of the branched stent graft 1130. In some other embodiments, the flexibility of the tail can be comparable to or less than the flexibility of the engagement portion 1131.

[0097] In some embodiments, the tail 1136 of the branched stent graft 1130 can include a covering 1138 that is made of a suitable material of a suitable thickness and has strain capabilities to impart the desired flexibility to the branched stent 1130 and allow the branched stent graft to expand. For example, the covering 1138 can be formed of one or more suitable materials having a suitable microstructure such that the flexibility of the branched stent graft 1130 can be precisely controlled. As an example, the covering 1138 can be configured to have strain capabilities to support the expansion of the branched stent from a first diameter dimension (e.g., about 2 mm) to a second substantially expanded diameter dimension (e.g., about 4 - 12 mm) without failure. That is, the strain capabilities of the covering 1138 can be designed to withstand the expansion of the branched stent within an exemplary range of 2 mm - 4 mm to 2 mm - 12 mm. In some embodiments, the covering can have strain capabilities of at least about two times, at least about three times, at least about four times, or at least about five times the diameter expansion of the engagement portion without experiencing failure (e.g., tearing, ripping, etc.).

[0098] In some embodiments, the cover 1138 may be disposed on the flexible tail 1136, the junction portion 1131, the transition portion, or any combination thereof. In other words, the cover may be disposed on any individual portion, multiple portions, or the entire branched stent graft 1130. Additionally, the cover 1138 disposed over the junction portion 1131, the transition portion 1133, and / or the tail 1136 of the branched stent graft 1130 may be configured to impart the desired flexibility to each of the junction portion, the transition portion, and the tail of the branched stent 1130. For example, the cover disposed on one or more of the above portions may be a suitable material with a suitable microstructure and may be made of a suitable number of layers to a suitable thickness to provide the desired flexibility with substantially precise control.

[0099] The transition portion of the branched stent 1130 may be of a suitable flexibility or rigidity to prevent any kink formation or structural fatigue between the fenestration body 1160 and the branched stent 1130. For example, in some embodiments, the flexibility of the transition portion 1133 of the branched stent 1130 may be greater than the flexibility of the junction portion 1131 and less than the flexibility of the flexible tail of the branched stent 1130. In other words, the tail 1136 may be configured to be substantially more flexible than the transition portion 1133 and the junction portion 1131. For example, the flexibility of the tail 1136 of the branched stent 1130 may be configured such that when a deflection force of less than 1 N is applied, the branched stent 1130 deflects at least about 1 mm, at least about 2 mm, at least about 3 mm, or at least about 4 mm from its longitudinal axis at a longitudinal distance of 20 mm from the junction portion 1131 of the branched stent. In other words, the flexible tail defines a longitudinal central axis in a first stress-free state and is configured to deflect to a second stress state when a deflection force of less than about 1 N is applied at a longitudinal distance of 20 mm away from the junction portion. When such a deflection force is applied, the flexible tail moves from the first state to the second state by at least about 1 mm, at least about 2 mm, at least about 3 mm, or at least about 4 mm. In some other embodiments, the transition portion 1133 may be configured to have a flexibility comparable to or less than that of the junction portion 1131 and / or the tail of the branched stent 1130.

[0100] Figure 14 is a schematic cross-sectional side view of a system 1300 including a branched stent graft 1330 of another shape according to one embodiment. As Figure 14As shown, system 1300 includes a branched stent graft 1330 and a fenestrated body 1360. The branched stent graft 1330 can be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 1360 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. The fenestrated body 1360 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (such as stent graft 160 or stent graft 260). The fenestrated body 1360 can define a window 1365 and include a junction portion 1368 surrounding the window 1365. The junction portion 1368 can be configured to be coupled to the branched stent graft 1330. In some embodiments, the junction portion 1368 includes a reinforced and / or marked edge of the wall of the fenestrated body 1360 in the region surrounding the window 1365. In other embodiments, the junction portion 1368 includes the wall of the fenestrated body 1360 in the region surrounding the window 1365 but is not reinforced.

[0101] The branched stent graft 1330 can include a junction portion 1331. The junction portion 1331 can include a first larger diameter portion 1331A and a second larger diameter portion 1331B. The junction portion 1331 can be coupled to the junction portion 1368 of the fenestrated body 1360 such that the junction portion 1368 of the fenestrated body 1360 is positioned between the first larger diameter portion 1331A and the second larger diameter portion 1331B. Thus, the branched stent graft 1330 can move relative to the junction portion 1368 of the fenestrated body 1360. The first larger diameter portion 1331A and the second larger diameter portion 1331B can each have a diameter larger than the diameter of the window 1365 defined by the junction portion 1368 of the fenestrated body 1360, thereby restricting or preventing axial movement of the branched stent graft 1330 relative to the main stent graft 1360 while still allowing rotational and / or pivotal movement relative to the main stent graft 1360. Although the first larger diameter portion 1331A is shown as being smaller in size than the second larger diameter portion 1331B, in some embodiments, the first larger diameter portion 1331A can have the same size or a larger size than the second larger diameter portion 1331B.

[0102] Figure 15It is a schematic diagram of a cross-sectional side view of system 1400. System 1400 includes a branched stent graft 1430 having a bilateral engagement portion 1431. System 1400 also includes a fenestrated body 1460. The branched stent graft 1430 can be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 1460 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. The fenestrated body 1460 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (such as stent graft 160 or stent graft 260). The fenestrated body 1460 can define a window 1465 and include an engagement portion 1468 surrounding the window 1465. The engagement portion 1468 can be configured to be coupled to the branched stent graft 1430. In some embodiments, the engagement portion 1468 includes reinforcement and / or marked edges of the wall of the fenestrated body 1460 in the region surrounding the window 1465. In other embodiments, the engagement portion 1468 includes the wall of the fenestrated body 1460 in the region surrounding the window 1465 but is not reinforced.

[0103] The bilateral engagement portion 1431 is configured to be movably coupled to the engagement portion 1468 of the fenestrated body 1460. The engagement portion 1431 of the branched stent graft 1430 includes a first engagement feature 1431A and a second engagement feature 1431B. The engagement portion 1431 (and thus the first engagement feature 1431A and the second engagement feature 1431B) can be any suitable shape capable of engaging the engagement portion 1468 from the inside and / or outside of the fenestrated body 1460. For example, in some embodiments, the first engagement feature 1431A and the second engagement feature 1431B can be constructed and attached to the fenestrated body 1460 in a manner similar to that of a patent foramen ovale (PFO) closure device with an attached stent.

[0104] In some embodiments, the first engagement feature 1431A and the second engagement feature 143B may each be formed as expandable rings and disposed on either side of the engagement portion 1468. The first engagement feature 1431A may be positioned on a first side of the engagement portion 1468 (e.g., inside the fenestrated body 1460). The second engagement feature 1431B may be positioned on a second side of the engagement portion 1468 opposite the first side (e.g., outside the fenestrated body 1460). The engagement portion 1431 may be coupled to the engagement portion 1468 of the main stent graft 1460 such that the engagement portion 1468 of the fenestrated body 1460 is movably fixed between the first engagement feature 1431A on the first side and the second engagement feature 143B on the second side. In such a configuration, the branch stent graft 1430 may rotate and / or displace relative to the engagement portion 1468 of the fenestrated body 1460. The diameters of the first engagement feature 1431A and the second engagement feature 1431B may be greater than the window diameter defined by the engagement portion 1468, thereby preventing the branch stent graft 1430 from axially moving away from the fenestrated body 1460 while still allowing rotational movement relative to the fenestrated body 1460.

[0105] In some embodiments, the engagement portion 1431 of the branch stent graft 1430 includes an X-shaped saddle such that the first engagement feature 1431A includes a first fork element and a second fork element, and the second engagement feature 1431B includes a third fork element and a fourth fork element. The first fork element and the second fork element may be positioned on a first side of the engagement portion 1468 (e.g., inside the fenestrated body 1460). The third fork element and the fourth fork element may be positioned on a second side of the engagement portion 1468 opposite the first side (e.g., outside the fenestrated body 1460). The engagement portion 1431 may be coupled to the engagement portion 1468 of the main stent graft 1460 such that the engagement portion 1468 of the fenestrated body 1460 is movably fixed between the first fork element and the third fork element on the first side and between the second fork element and the fourth fork element on the second side. In such a configuration, the branch stent graft 1430 may rotate and / or displace relative to the engagement portion 1468 of the fenestrated body 1460. The distance between the first fork element and the second fork element and the distance between the third fork element and the fourth fork element may be greater than the window diameter defined by the engagement portion 1468, thereby preventing the branch stent graft 1430 from axially moving away from the fenestrated body 1460 while still allowing rotational movement relative to the fenestrated body 1460.

[0106] In some embodiments, the branch stent graft may include an anchoring member for engaging the inner wall of the fenestrated body (e.g., the main stent graft or the vessel wall). For example, Figures 16A - 16ESchematic diagrams of various views and configurations of system 1500. System 1500 includes a branched stent graft 1530, which includes an anchoring member 1550 and a fenestrated body 1560. The branched stent graft 1530 can be any suitable stent, such as a bridging stent or a FEVAR stent. The fenestrated body 1560 can be, for example, a blood vessel wall or a main stent graft, such as an aortic stent graft. The fenestrated body 1560 can have the same or similar structure and / or function as any other fenestrated body or stent graft described herein (e.g., stent graft 160 or stent graft 260). The fenestrated body 1560 can define a window 1565 and include a junction portion 1568 surrounding the window 1565. The junction portion 1568 can be configured to be coupled to the branched stent graft 1530. In some embodiments, the junction portion 1568 includes a reinforced and / or marked edge of the wall of the fenestrated body 1560 in the region surrounding the window 1565. In other embodiments, the junction portion 1568 includes the wall of the fenestrated body 1560 in the region surrounding the window 1565 but is not reinforced.

[0107] The anchoring member 1550 can have the form of a parachute or flared end of the branched stent graft 1530. The anchoring member 1550 can move from a folded delivery configuration to an expanded anchoring configuration. As Figure 16A (which is a schematic cross-sectional side view of system 1500 in a first configuration) shows, the anchoring member 1550 can be delivered to the window 1565 in a folded delivery configuration. In some embodiments, the anchoring member 1550 can be delivered to the window within a delivery tube (not shown). The anchoring member 1550 can be biased toward the expanded configuration such that the anchoring member 1550 can be compressed within the delivery tube and then automatically move to the expanded configuration when removed from the delivery tube. As Figure 16B (which is a schematic cross-sectional side view of system 1500 in a second configuration) shows, the anchoring member 1550 can expand to the expanded anchoring configuration, for example, after being delivered from the end of the delivery tube. Once the anchoring member 1550 is deployed to the expanded anchoring configuration, the anchoring member 1550 can be positioned against the inner surface of the wall of the fenestrated body 1560 such that the anchoring member 1550 engages the junction portion 1568 of the fenestrated body 1560 (e.g., such that the anchoring member 1550 abuts the junction portion 1568), as Figure 16C shown. In such a configuration, the branched stent graft 1530 can be positioned such that the branched stent graft 1530 extends through the window 1565 but cannot axially move relative to the window 1530. As Figure 16D shown, once the anchoring member 1550 is positioned in an engaging relationship with the junction portion 1568, the branched stent graft 1530 can be expanded, for example, via an expandable member (such as a balloon) within the window 1565. Figure 16EIt is a schematic view of the inner wall of the fenestrated body 1560, where the anchoring member 1550 is fixed to the engaging portion 1568 of the fenestrated body 1560. In some embodiments, the anchoring member 1550 and the branched stent graft 1530 can be attached to the fenestrated body in a manner similar to that of a patent foramen ovale (PFO) closure device with an attached stent.

[0108] Although Figures 16A - 16E only one anchoring member 1550 is shown, in some embodiments, a second anchoring member can be included such that the second anchoring member engages the outer wall of the fenestrated body 1560. For example, a self-expanding parachute can be provided on the branched stent graft 1530 such that a first self-expanding parachute can open inside the fenestrated body 1560 while a second self-expanding parachute can open outside the fenestrated body 1560, thereby fixing the branched stent graft 1530 to the fenestrated body 1560.

[0109] In use, as described above, the branched stent graft 1530 can be delivered to the target location using a deployment device. For example, the branched stent graft 1530 can pass through the fenestrated body 1560 via a guidewire catheter and be delivered from the window 1565 of the fenestrated body 1560 to the branched artery ( Figures 16A - 16E not shown). In some embodiments, a delivery tube can be used to position the branched stent graft 1530 such that the anchoring member 1550 is within the lumen of the fenestrated body 1560 and another portion of the branched stent graft 1530 is within the branched artery (similar to the configuration as Figure 16A shown). In this position, the anchoring member 1550 (e.g., a parachute) can be deployed (similar to the configuration as Figure 16B shown). For example, the anchoring member 1550 or the entire branched stent graft 1530 can be pushed out of one end of the delivery tube and automatically expand to the Figure 16B shown configuration. Then the anchoring member 1550 can be pushed towards the window 1530 such that the anchoring member 1550 abuts the area of the fenestrated body surrounding the window (e.g., the engaging portion 1568 as Figure 16C shown). In the case where the anchoring member abuts the wall and / or the engaging portion of the fenestrated body, the branched stent graft 1530 can axially expand within the window 1565 and the branched artery (as shown in the configuration as Figure 16D shown). For example, an expandable member (e.g., a balloon) can be inserted into the annulus of the branched stent graft 1530 and expanded, thereby expanding the branched stent graft 1530 to a wider diameter configuration within the window 1565.

[0110] Although various embodiments of systems, methods, and apparatuses have been described above, it should be understood that they are presented by way of example only and not as limitations. In instances where the above methods and steps indicate that certain events occur in a particular order, those of ordinary skill in the art having the benefit of this disclosure will recognize that the order of certain steps can be modified and that such modifications are in accordance with variations of the invention. Additionally, certain steps can be performed concurrently in parallel processing where possible, as well as sequentially as described above. Embodiments have been specifically shown and described, but it will be understood that various changes can be made in form and detail.

[0111] For example, although the various embodiments have been described as having combinations of specific features and / or components, other embodiments can have any combination or partial combination of any features and / or components from any of the embodiments described herein. Additionally, the specific construction of the various components can be changed. For example, the dimensions and specific shapes of the various components can be different from those of the illustrated embodiments while still providing the functionality described herein.

Claims

1. A radially expandable branched stent graft assembly, comprising: A joining portion for joining with an opening in a fenestrated body, the joining portion having a first joining feature (1431A) on a first side of the joining portion and a second joining feature (1431B) on a second side of the joining portion, the first joining feature (1431A) being configured to be disposed inside the fenestrated body (1160), the second joining feature (1431B) being configured to be disposed outside the fenestrated body (1160), the joining portion being configured to allow the branched stent graft to pivot around the opening of the fenestrated body and to restrict axial movement of the branched stent graft relative to the fenestrated body; and A flexible tail extending from the joining portion.

2. The branched stent graft assembly according to claim 1, wherein the first joining feature joins the inside of the fenestrated body.

3. The branched stent graft assembly according to claim 1, wherein the second joining feature joins the outside of the fenestrated body.

4. The branched stent graft assembly according to claim 1, wherein at least one of the first joining feature and the second joining feature is an expandable ring.

5. The branched stent graft assembly according to claim 1, wherein the diameters of the first joining feature and the second joining feature are greater than the diameter of the window.

6. The branched stent graft assembly according to claim 1, wherein the first joining feature and the second joining feature are configured as an X-shaped saddle.

7. The branched stent graft assembly according to claim 1, wherein the joining portion is rigid.

8. The branched stent graft assembly according to claim 1, wherein the joining portion is flexible.

9. The branched stent graft assembly according to claim 8, wherein the joining portion defines a longitudinal central axis, and the joining portion is configured to hold the longitudinal central axis substantially perpendicular to the plane defined by the opening in the fenestrated body.

10. The branched stent graft assembly according to claim 1, wherein at least a portion of the flexible tail has a covering.

11. A radially expandable branched stent graft assembly, comprising: A joining portion (1568) defining an opening in a fenestrated body, A first anchoring member (1550) extending through the opening and configured to engage the inner wall of the fenestrated body (1560), a second anchoring member configured to be disposed outside the fenestrated body (1560), the first anchoring member and the second anchoring member being configured to allow the branched stent graft to pivot around the opening of the fenestrated body and to restrict axial movement of the branched stent graft relative to the fenestrated body; and A flexible tail extending from the first anchoring member and the second anchoring member.

12. The branched stent graft assembly according to claim 11, wherein at least one of the first anchoring member and the second anchoring member includes a folded delivery configuration and an expanded anchoring configuration.

13. The branched stent graft assembly according to claim 11, wherein at least one of the first anchoring member and the second anchoring member includes a flared end.

14. The branched stent graft assembly according to claim 11, wherein at least one of the first anchoring member and the second anchoring member abuts an area of the fenestrated body surrounding the window.

15. The branched stent graft assembly according to claim 11, wherein the branched stent graft assembly is configured to maintain a longitudinal central axis substantially perpendicular to a plane defined by the opening in the fenestrated body.

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