Systems, devices and methods for coupling a prosthetic implant to a fenestrated body

Abstract

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

Description

[0001] This application is a divisional application of an invention patent application with an application date of August 1, 2017, application number 201780061126.1 (international application number PCT / US2017 / 044822), and invention name “System, device and method for connecting a prosthetic implant to an open window body”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

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

[0004] Embodiments described herein relate generally to prosthetic implants and, more particularly, to devices and methods for engaging a prosthetic implant (eg, a branch vessel stent graft) within a window of a second prosthetic implant (eg, an aortic stent graft). Background Art

[0005] Prosthetic devices are usually implanted in, for example, diseased parts of patients to repair, support, support and / or otherwise promote the proper function of those diseased parts. In some cases, prosthetic devices such as stent grafts can be used to repair diseased parts of patient vascular systems. For example, aneurysms in patient vascular systems usually involve abnormal swelling or expansion of blood vessels (e.g., arteries), which usually weaken the vessel wall, making it easy 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 intravascular stent graft in the affected blood vessel so that the stent graft spans (e.g., crosses) and extends beyond the proximal and distal ends of the diseased part of the vascular system. Therefore, the stent graft can re-divide the diseased vascular system, 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 such an implant and / or mechanism that can provide structural or functional support for the diseased and / or defective part of the body. However, in some cases, the arrangement of the anatomy may present challenges when attempting to place and / or secure a prosthetic device, including a stent graft, etc. These challenges may result in malposition and / or suboptimal configuration of the prosthetic device within the anatomy.

[0006] Minimally invasive endovascular repair using stent grafts is often 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 the main branch vessels. In the case of adrenal artery aneurysms that extend to the renal arteries but do not involve the renal arteries, the proximal portion of the stent graft needs to be fixed to the aortic wall above the renal arteries, thereby blocking the opening of the renal arteries. Therefore, patients with juxtarenal artery aneurysms (which represent a significant proportion of abdominal aortic aneurysm cases) are usually excluded from endovascular treatment.

[0007] In order to allow endovascular repair of a wider range of cases, surgeons sometimes cut openings in the body of the stent graft to accommodate specific branch vessel origins, a process known as "fenestration". Thus, for example, when using a procedure known as fenestrated endovascular aortic repair ("FEVAR") to treat a juxtarenal artery aneurysm, the window or opening of the aortic stent graft will be aligned with the branch vessel. Additional stent grafts (e.g., renal stents) can then be placed in the branch vessels and secured to the main stent graft (e.g., aortic stent graft) to limit movement of the main stent graft within the anatomical structure and ensure proper blood flow. Additionally, in some cases, an endovascular stent graft can be placed in one or more specific branch vessels to further treat the aneurysm and / or strengthen the branch vessels in the aneurysm region. Summary of the invention

[0008] Disclosed herein are devices, systems, and methods for coupling a prosthetic implant to a fenestration. In some embodiments, a branch stent graft is provided. The branch stent graft may include an engagement portion for engaging with an opening in a fenestration (e.g., a vessel wall or an aortic stent graft). The engagement portion of the branch stent graft may be coupled to the fenestration such that the branch stent graft may be rotated or displaced relative to the fenestration, but axial movement of the branch stent graft is limited and / or prevented. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0010] Figure 2A is according to one embodiment and just placed in Figure 1 Part of a stent graft placed inside the diseased abdominal aorta.

[0011] Figure 2B is placed Figure 1 The diseased abdominal aorta is left there for a period of time. Figure 2A part of a stent graft.

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

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

[0014] Figure 5A is a schematic diagram of a front view of an open window body according to one embodiment.

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

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

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

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

[0019] Fig. 9 is a schematic diagram of a cross-sectional side view of a system according to one embodiment.

[0020] Fig.10 is a schematic diagram of a cross-sectional side view of a system according to one embodiment.

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

[0022] Fig.12 is a schematic diagram of a cross-sectional side view of a system according to one embodiment.

[0023] Fig.13A is a schematic diagram of a cross-sectional side view of a system in a first configuration according to one embodiment.

[0024] Fig. 13B It is in the second configuration Fig.13A Schematic diagram of a cross-sectional side view of the system.

[0025] Fig.14 is a schematic diagram of a cross-sectional side view of a system according to one embodiment.

[0026] Fig.15 is a schematic diagram of a cross-sectional side view of a system according to one embodiment.

[0027] Fig.16A is a schematic diagram of a cross-sectional side view of a system in a first configuration according to one embodiment.

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

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

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

[0031] Fig.16E It is in the second configuration Fig.16D Schematic diagram of the inner wall of the system. DETAILED DESCRIPTION

[0032] Disclosed herein are devices, systems, and methods for coupling a prosthetic implant to a window body. In some embodiments, the window body includes a flexible engagement portion. The prosthetic implant may be configured to engage with the flexible engagement portion so that the prosthetic implant can rotate relative to the window body while maintaining a perpendicular angle between the longitudinal center axis of the prosthetic implant and the plane of the flexible engagement portion.

[0033] In some embodiments, a branch stent graft is provided. The branch stent graft may include an engagement portion for engaging with an opening in a fenestration (e.g., a vessel wall or an aortic stent graft). The engagement portion of the branch stent graft may be coupled to the fenestration such that the branch stent graft may be rotated or displaced relative to the fenestration, but axial movement of the branch stent graft is limited and / or prevented.

[0034] As used in this specification, the singular forms "a," "an," "said," and "the," whether modified in the singular or in the plural, include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "member" is intended to mean a single member or a combination of members, and "material" is intended to mean one or more materials or a combination thereof.

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

[0036] Embodiments described herein can be formed or constructed by one or more biocompatible materials. The example of suitable biocompatible materials includes metal, ceramic or polymer. The example of suitable metal includes pharmaceutical grade stainless steel, gold, titanium, tungsten, nickel, iron, platinum, tin, chromium, copper and / or its alloy. The example of polymer includes nylon, polyester, polycarbonate, polyacrylate, ethylene vinyl acetate and other acyl substituted cellulose acetate polymer, non-degradable polyurethane, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly (vinyl imidazole), chlorosulfonate polyolefin, polyethylene oxide, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyurethane and / or its blend and copolymer.

[0037] The embodiments and methods described herein can be used to form patient-specific prosthetic devices and / or promote the function and / or integration of prosthetic devices within a part of a patient. For example, in some embodiments, the devices and / or methods described herein can be used in conjunction with and / or can be included in endovascular repair using a stent graft. Although embodiments are shown and described herein, for example, to promote endovascular repair, in other embodiments, any device and / or method described herein can be used to promote treatment of any part of a patient. For example, the devices and methods described herein can be formed and / or can promote the integration of any suitable implant, prosthesis, device, mechanism, machine, etc. within a part of a patient's body (e.g., the patient's vascular system, nervous system, muscular-skeletal system, etc.). Therefore, although some embodiments are shown and described herein for endovascular repair of abdominal aortic aneurysms, they are presented as examples and are not limited thereto.

[0038] Some of the devices and / or methods described herein may be used in minimally invasive treatment techniques, such as endovascular repair using stent grafts. Such repair techniques are generally superior to traditional open surgical repairs and generally result in reduced morbidity or mortality. However, in some cases, the arrangement of the diseased vasculature may necessitate the need to alter a portion of the stent graft prior to insertion into the body. For example, in the endovascular repair of an abdominal aortic aneurysm, the aneurysm may be located adjacent to and / or directly distal to a normally functioning vessel that branches off a portion of the aorta. In order to resegment the aneurysm with a stent graft, the surgeon often cuts openings in the fabric of the stent graft to accommodate the origin of a particular branch vessel, a process known as "fenestration." Specifically, in the treatment of juxtarenal artery aneurysms and / or in the treatment of other aneurysms, such as Figure 1 As shown in FIG, the windows or openings of the stent-graft may correspond in size, shape, and / or relative position to the renal arteries, the superior mesenteric artery (SMA), and / or the celiac artery ( Figure 1 ).

[0039] Traditionally, the fenestration process involves measurements based on medical images (e.g., CT scans) of the vessel's origin. For example, in some cases, the longitudinal distance of the branch vessel can be measured, and the relative angular position of the branch vessel can be estimated and / or calculated based on the reference point. Based on these measurements and / or calculations, the 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 vascular system (e.g., by endovascular surgery) and oriented so that the window is substantially aligned with the opening of the corresponding branch vessel.

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

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

[0042] Figure 1-2B A diseased portion of the abdominal aorta 10 of a patient is shown. Although portions of the abdominal aorta 10 are described below, the discussion of the abdominal aorta 10 is not exhaustive; rather, the discussion below provides references to relevant anatomical structures. In addition, discussion of anatomical structures (e.g., the abdominal aorta 10) relates to the position, orientation, etc. of such structures relative to the patient as viewed by an observer (e.g., a physician). For example, when referring to the left side of the patient or to an anatomical structure disposed on or near the "left" side of the patient, "left" is intended to describe a position relative to the patient and / or from the patient's perspective as viewed from the front (e.g., forward).

[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 limbs. Figure 1 As 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. Figure 1 , but the proximal portion 11 of the aorta 10 also supplies blood to the superior mesenteric artery (SMA) and the celiac artery. The distal portion 12 of the aorta 10 forms an iliac bifurcation 20, through which the aorta 10 supplies blood 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. Figure 1As shown, the patient has an abdominal aortic aneurysm (AAA) 17 located distal to the renal arteries 13 and 14 and near the iliac bifurcation 20. More specifically, the AAA 17 is disposed in a position that prevents the proximal portion of the stent graft from attaching between the renal arteries 13 and 14 and the AAA 17, and thus a fenestrated stent graft 160 (see, e.g., Figure 2A and 2B ) has been used for endovascular repair of AAA 17.

[0044] In some cases, endovascular repair of 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 a 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, a physician, surgeon, technician, manufacturer, etc. can use the imaging data to determine and / or calculate the size, shape, position, and / or orientation of the aorta 10, 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, a physician, surgeon, technician, manufacturer, etc. may form and / or define one or more windows 165 in stent graft 160 that are associated with determined and / or calculated characteristics of at least 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] like Figure 2A As shown, stent graft 160 can be positioned within a portion of the patient's abdominal aorta 10 via an endovascular procedure. For example, stent graft 160 can be disposed within a delivery catheter (e.g., in a folded, compressed, constrained, and / or other non-deployed configuration) that is inserted, for example, into a femoral artery (not shown). The delivery catheter can be advanced through the artery and into the abdominal aorta 10. Once advanced to a desired location within the abdominal aorta 10, the delivery catheter can be withdrawn relative to stent graft 160. When the delivery catheter is retracted and / or withdrawn, stent graft 160 transitions from a folded configuration to an expanded or deployed configuration, thereby supporting a portion of the abdominal aorta 10.

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

[0047] Stent graft 160 also includes a set of reinforcing members 164 disposed circumferentially about stent graft 160. Reinforcing members 164 can be any suitable structure that can, for example, bias stent graft 160 into an open configuration, thereby structurally supporting stent graft material (also referred to as a "stent fabric" or "graft fabric"). In some embodiments, reinforcing members 164 can be formed, for example, from metals or metal alloys such as those described above. In some embodiments, for example, such metals or metal alloys are radiopaque and / or coated with a radiopaque material that is configured to be visible using, for example, fluoroscopy. Figure 2A As shown, the reinforcement member 164 can be transitioned from a constrained or deformed delivery configuration (eg, when disposed in a delivery catheter) to an expanded and / or biased indwelling 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. The imaging data and / or digital representations can then be used by a physician, surgeon, technician, and / or manufacturer 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 FIG. Figure 2A 1 , but stent-graft 160 may define one or more windows associated with other branch vessels originating from aorta 10 (eg, superior mesenteric artery (SMA), celiac artery, etc.).

[0049] like Figure 2BAs shown, the placement and / or retention of stent graft 160 within aorta 10 can, for example, change, displace, rotate, translate, deform, and / or otherwise reconfigure the arrangement of the patient's aorta 10. As a result, the openings of renal arteries 13 and 14 are displaced relative to windows 165 defined by stent graft 160. In some cases, the displacement of aorta 10 relative to stent graft 160 results in at least partial obstruction of renal arteries 13 and 14, such as Figure 2B As shown. For example, in some cases, the openings of the renal arteries 13 and 14 can be approximately 4 millimeters (mm) to approximately 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 by approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 6 mm, approximately 7 mm, or more (or intervals of less than one millimeter) relative to the window 165. Therefore, although the window 165 is defined at a desired position along the stent graft 160 based on the imaging data, the displacement of the aorta 10 caused by the placement and / or retention of the stent graft 160 can cause obstruction of the renal arteries 13 and 14. In some cases, the displacement of the aorta 10 can cause obstruction of the renal arteries 13 and 14 by approximately 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% (or any percentage or fractional percentages thereof). Although not in Figure 2A and 2B 1, but displacement of aorta 10 may result in similar misalignment of any branch vessels relative to their corresponding windows in stent graft 160. In some embodiments, the electronic device may be configured to determine and / or calculate displacement of anatomical structures caused by insertion and / or placement of a prosthesis (e.g., a stent graft), and may determine one or more digital representations of the displaced anatomical structures. 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 may be formed in a stent graft (e.g., stent graft 160) based on the calculated displacement.

[0050] Figure 3At least a portion of a fenestrated stent graft 260 according to one embodiment is shown. As described above, the stent graft can 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 an inner cavity 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 a size, shape, and / or configuration corresponding to the patient's anatomical structure.

[0051] 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, stent-graft 260 can have dimensions associated with the size of the lumen defined by the aorta. In other embodiments, fenestrated stent-graft 260 can have dimensions associated with an adjusted or calculated size of the lumen defined by the aorta resulting from intravascular placement of stent-graft 260. Furthermore, stent-graft 260 can have any suitable mechanical properties, such as strength, stiffness, etc.

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

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

[0054] As described above, stent graft 260 can be any suitable stent graft and can be formed by any suitable manufacturing process. In some embodiments, stent graft 260 can be manufactured as a ready-made stent graft, and window 265 can be formed in graft material 266 in a subsequent manufacturing process. In other embodiments, stent graft 260 can be manufactured as a "custom" or non-ready-made stent graft. Although specific manufacturing methods are described herein, it should be understood that these methods are presented only as examples and not limitations. In addition, the manufacturing methods described herein can be performed in a single facility and / or a single manufacturing process, or in multiple facilities and / or multiple manufacturing processes. In some cases, various parts of the manufacturing methods described herein can be performed by an end user (e.g., a physician, surgeon, technician, nurse, etc.). Therefore, although the manufacture of stent graft 260 is specifically described below, 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 calculations of, for example, anatomical imaging data of the patient, stent graft 260 may be manufactured to have a general shape, diameter, length, etc. associated with the patient's aorta. In other embodiments, stent graft 260 may have a general shape, size, and / or configuration associated with an updated model determined by the electronic device, which in turn corresponds to a calculated, predicted, and / or modified arrangement of the aorta in response to, for example, insertion and placement of stent graft 260 as described in detail above. Thus, stent graft 260 generally has a tubular or cylindrical shape. In some embodiments, the diameter of lumen 263 is based at least in part on the diameter of the calculated, predicted, and / or modified lumen defined by the aorta. In addition, stent graft 260 may have rigidity and / or any other suitable mechanical properties associated with the expected amount and / or method of aortic displacement caused by insertion and / or placement of 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 may be defined along stent graft 260 such that each window 265 corresponds to a calculated location of a respective branch vasculature (e.g., a renal artery), and each window 265 may 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] like Figure 4 As shown, when windows 265 are defined 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 patient's aorta 10. As shown, the stent graft 260 can include, for example, a first set of windows 265A, which 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 a size, shape, and / or configuration associated with its corresponding renal artery 13 or 14. In some embodiments, the size, shape, and / or position of the window 265A is associated with and / or substantially corresponds to the adjusted and / or calculated size, shape, and / or position of the corresponding renal artery 13 and 14. For example, placing the stent graft 260 within the aorta 10 can, for example, change, shift, rotate, translate, deform, and / or otherwise reconfigure the arrangement of the patient's aorta 10. Thus, by deviating stent-graft 260 from the updated model, the size, shape, and / or location of window 265 defined by stent-graft 260 can be made to correspond to the desired branch vasculature (e.g., right renal artery 13 and / or left renal artery 14). Furthermore, in addition to positioning stent-graft 260 within a portion of the patient's aorta 10, renal arteries 13 and / or 14 can also be positioned, for example, via window 265A ( Figure 4 The renal artery can be stented with an auxiliary branch stent ( Figure 4 265A) is performed, the auxiliary branch stent is engaged with the open window of stent graft 260 at the window 265A and extends in the branch artery such as renal artery 13 and / or 14. In this way, the window 265A on stent graft 260 and the auxiliary branch stent (not shown) positioned to correspond to the branch artery can help the axial and / or radial alignment and positioning of stent graft 260 during deployment. In addition, the window 265A and the auxiliary branch stent (not shown) can also help to maintain the alignment and positioning of stent graft 260 relative to the patient's aorta 10 after placement.

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

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

[0060] In some embodiments, the window 265 can be marked to facilitate the positioning of the window 265 during the deployment of the stent graft 260 and facilitate the connection of the branch stent (not shown) to the stent graft 260. For example, the peripheral edge 267A or 267B of the stent graft 260 defining the window 265A or 265B can be sutured using a gold thread and / or a thread of other radiopaque material. Similarly, the position of the window 265 can be marked by one or more radiopaque markers. Such radiopaque threads or markers can facilitate fluoroscopic visualization of the window 265 during the endovascular repair procedure and allow the physician to position the window 265 relative to the corresponding branch vessel. In other embodiments, the window 265 can be sutured and / or otherwise marked using any suitable material that can increase visibility when using any suitable imaging device (e.g., MRI scan, CAT scan, PET scan, X-ray scan, ultrasound device, etc.). These markers can be placed and / or sutured using any suitable manufacturing process, which can be combined or separated from the formation of the window 265.

[0061] As described above, in some embodiments, an auxiliary branch stent can 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 can 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 can be disposed within a branch vessel (e.g., SMA 18) extending from the patient's aorta so that the auxiliary stent can help strengthen the branch vessel in an open position. In addition, the auxiliary stent can 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 can move within and / or relative to the window so that branch vessel movement can be accommodated (i.e., vessel curvature can be compensated and vessel kinking can be prevented). In some embodiments, the fenestration body (e.g., the main stent graft) can include a flexible portion surrounding the window so that a rigid branch stent engaged with the fenestration body at the window can rotate within the window. For example, Figure 5A 460. Open window 460 can be, for example, a main stent graft such as an aortic stent graft. Open window 460 can have the same or similar structure and / or function as any other open window or stent graft described herein (e.g., stent graft 160 or stent graft 260). Open window 460 can define a window 465 and include a coupling portion 468 surrounding window 465. Coupling portion 468 can be flexible and can be configured to engage with branch stent graft 430 (e.g., Figures 5B-5D The branch stent graft 430 may be any suitable stent, such as a bridge stent or a FEVAR stent.

[0062] Figures 5B-5D Schematic diagrams of side views of system 400 in first, second, and third configurations, respectively. System 400 includes an open window body 460 and a branch stent graft 430. Branch stent graft 430 can be rigid or flexible. Engagement portion 468 can be configured such that when branch stent graft 430 is passed through Figures 5B-5D When the configuration shown in FIG. 4 is moved relative to the open window body 460, the plane or surface of the engagement portion 468 remains perpendicular to the longitudinal center axis of the branch stent graft 430. Figure 5B As shown, branch stent graft 430 can be positioned in a first configuration, wherein the longitudinal center axis of branch stent graft 430 is perpendicular to the wall of fenestration body 460. Figure 5C As shown, the branch stent graft 430 can be shifted to a second position (i.e., a second configuration) relative to the branch stent graft 430. Figure 5D As shown, branch stent graft 430 can be displaced to a third position (i.e., a third configuration) relative to branch stent graft 430. Figures 5B-5D 4. Although shown as having three configurations for illustrative purposes, the system 400 can have essentially an unlimited number of configurations. In other words, the engagement portion 468 is flexible enough to allow the longitudinal center axis of the branch stent graft 460 to remain aligned with the branch vessel regardless of the movement of the fenestration body 460.

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

[0064] In some embodiments, rather than the fenestration body including a flexible engagement portion, the engagement portion of the fenestration body may be rigid and the associated branch stent graft may be flexible. Figure 6 5 is a schematic diagram of a cross-sectional side view of a system 500, which includes an open window body 560 and a flexible branch stent graft 530. The branch stent graft 530 can be any suitable stent, such as a bridge stent or a FEVAR stent. The open window body 560 can be, for example, a main stent graft such as an aortic stent graft. The open window body 560 can have the same or similar structure and / or function as any other open window body or stent graft described herein (e.g., stent graft 160 or stent graft 260). The open window body 560 can define a window 565 and include a rigid engagement portion 568 surrounding the window 565. The engagement portion 568 may be substantially similar to those described in International Patent Application No. PCT / US2017 / 037157, filed on June 13, 2017, entitled “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] Flexible branch stent graft 530 may include a proximal end 535 and a distal end 537. Rigid engagement portion 568 may be securely coupled to proximal end 535 of flexible branch stent graft 530. Due to the flexibility of branch stent graft 530, distal end 537 of flexible branch stent graft 530 may be free to move. Factors that may affect the flexibility of branch stent graft 530 may include, for example, stent pattern, thickness of stent material, type of stent material, and / or type of connection between branch stent graft 530 and another stent. Flexible branch stent graft 530 may be displaced from a first position to a second position, represented by flexible branch stent graft 530'. In the second position, proximal end 535 of flexible branch stent graft 530 remains securely coupled to rigid engagement portion 568. However, distal end 537' is disposed in the second position relative to second end 537, and flexible branch stent graft 530' is bent into a different shape than in the first position. Due to the secure attachment between the proximal end 535 of the flexible branch stent graft 530 and the rigid engagement portion 568, the flexible branch stent graft 530 cannot move axially relative to the window 565 and the fenestration body 560. The secure connection between the proximal end 535 of the flexible branch stent graft 530 and the rigid engagement portion 568 can be achieved by any suitable connection structure. For example, the flexible branch stent graft 530 can include a ring with a flange on the proximal end 535.

[0066] The flange may be disposed adjacent to a portion of the rigid engagement portion 568 that faces the interior of the fenestration 560. In other embodiments, the proximal end 535 of the flexible branch stent graft 530 and the rigid engagement portion 568 may be engaged via a saddle feature (eg, saddle engagement portion 1031 described below).

[0067] In some embodiments, any suitable flexible branched stent graft can be configured to be securely coupled to the engagement portion of the fenestrated body. Figure 7 6 is a schematic diagram of a cross-sectional side view of a system 600, which includes a branch stent graft 630 and a fenestration body 660. The branch stent graft 630 can be any suitable stent, such as a bridge stent or a FEVAR stent. The fenestration body 660 can be, for example, a main stent graft such as an aortic stent graft. The fenestration body 660 can have the same or similar structure and / or function as any other fenestration body or stent graft described herein (e.g., stent graft 160 or stent graft 260). The fenestration body 660 can define a window 665 and include a joint portion 668 surrounding the window 665. The joint portion 668 can be rigid or flexible and can be configured to be securely coupled to the branch stent graft 630.

[0068] Branch 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, flexible branch stent graft 630 can be formed as an integral stent having a constant cylindrical outer diameter and can include portions having different flexibility or rigidity. Due to the flexibility of flexible stent portion 636, branch stent graft 630 can bend and / or rotate relative to engagement portion 668. For example, branch stent graft 630 can bend from a first position (wherein the central axis of branch stent graft 630 is perpendicular to the plane or surface of engagement portion 668) to a second position represented by branch stent graft 630' (wherein branch stent graft 630' has a curved central axis). As shown, second rigid stent portion 634' can be displaced to the second position while first rigid stent portion 632' remains firmly coupled to engagement portion 668 and is immovable relative to engagement portion 668. Additionally, the secure engagement between the first rigid stent portion 632 ′ and the engagement portion 668 may prevent axial movement of the branch stent graft 630 relative to the fenestrated body 660 .

[0069] In some embodiments, the first flexible support portion and the second flexible support portion can be connected by a rigid support portion. Figure 8 1 is a schematic diagram of a cross-sectional side view of system 1200, which includes a branch stent graft 1230 and a fenestration body 1260. Branch stent graft 1230 can be any suitable stent, such as a bridge stent or a FEVAR stent. Fenestration body 1260 can be, for example, a main stent graft such as an aortic stent graft. Fenestration body 1260 can have the same or similar structure and / or function as any other fenestration body or stent graft described herein (e.g., stent graft 160 or stent graft 260). Fenestration body 1260 can define a window 1265 and include a coupling portion 1268 surrounding window 1265. Coupling portion 1268 can be rigid or flexible and can be configured to be securely coupled to branch stent graft 1230.

[0070] Branch stent graft 1230 includes a first flexible stent portion 1232 and a second flexible stent portion 1234. First flexible stent portion 1232 and second flexible stent portion 1234 are coupled by rigid stent portion 1236. In other words, branch stent graft 1230 may be formed as an integral stent having a constant cylindrical outer diameter and may include portions having different flexibility or rigidity. Due to the flexibility of first flexible stent portion 1232 and second flexible stent portion 1234, branch stent graft 1230 may bend and / or rotate relative to junction portion 1268. For example, branch stent graft 1230 may bend from a first position, wherein the central axis of branch stent graft 1230 is perpendicular to the plane or surface of junction portion 1268, to a second position, represented by branch stent graft 1230', wherein branch stent graft 1230' has a changed central axis (i.e., the central axes of first flexible stent portion 1232 and second flexible stent portion 1234 are curved). As shown, the first flexible support portion 1232' and the second flexible support portion 1234' can be displaced to a second position, each having a second shape, while the rigid support portion 1236' maintains the same shape in the second position. In addition, the secure engagement between the first flexible support portion 1232' and the engagement portion 1268 can prevent axial movement of the branch stent graft 1230 relative to the open window body 1260.

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

[0072] The flexible branch 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 connected by a flexible rod-shaped tether 736. The first rigid stent portion 732 and the second rigid stent portion 734 can have the same or different sizes, lengths and / or shapes. Due to the flexibility of the tether 736, the flexible branch stent graft 730 can bend and / or rotate relative to the joint portion 768. For example, the flexible branch stent graft 730 can bend from a first position (wherein the central axis of the flexible branch 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 joint portion 768) to a second position represented by the flexible branch stent graft 730' (wherein the tether 736' is bent). As shown in FIG. Fig. 9 As shown, the second rigid stent portion 734' can be displaced to the second position, while the first rigid stent portion 732' remains securely coupled to the engagement portion 768 and cannot move relative to the engagement portion 768. In addition, the secure engagement between the first rigid stent portion 732 and the engagement portion 768 can prevent axial movement of the branch stent graft 730 relative to the fenestration body 760.

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

[0074] Flexible branch stent graft 830 includes a rigid stent portion 832, a flexible tail 836, and a flexible transition portion 833 connecting the rigid stent portion 832 and the flexible tail 836. The flexible transition portion 833 can be less flexible than the flexible tail 836, so 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 junction portion 868. For example, the flexible tail 836 can bend from a first position (wherein the central axis of the branch 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 junction portion 868) to a second position represented by the branch stent graft 830' (wherein 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 support portion 832' remains firmly coupled to the joint portion 868 and cannot move relative to the joint portion 868. The flexible tail 836' can be formed of any suitable material, such as a metal or metal alloy (e.g., nickel titanium (NiTi alloy), stainless steel, or cobalt chromium alloy) and / or a braided polymer or fabric (e.g., polytetrafluoroethylene (PTFE) or polyethylene terephthalate (PET or )). In addition, the secure engagement between the rigid stent portion 832 and the engagement portion 868 can prevent axial movement of the branch stent graft 830 relative to the fenestration body 860.

[0075] In some embodiments, the branch stent graft can be configured to movably engage with the engagement portion of the fenestration body. For example, in some embodiments, the engagement portion of the fenestration body and the engagement portion of the branch stent graft can both be rigid. The engagement portion of the fenestration body and the engagement portion of the branch stent graft can engage and / or interlock so that the branch stent graft can move and / or rotate relative to the fenestration body. For example, Figures 11A-11C960 is a schematic diagram of a cross-sectional side view of a system 900, which includes a branch stent graft 930 and a window body 960. The branch stent graft 930 can be any suitable stent, such as a bridge stent or a FEVAR stent. The window body 960 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. The window body 960 can have the same or similar structure and / or function as any other window body or stent graft described herein (e.g., stent graft 160 or stent graft 260). The window 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 be coupled to the branch stent graft 930. In some embodiments, the rigid engagement portion 968 includes a reinforcement and / or marking edge of the wall of the window body 960 in the area around the window 965. In other embodiments, the rigid engagement portion 968 includes the wall of the window body 960 in the area around the window 965 but is not reinforced.

[0076] Branch stent graft 930 may include an engagement portion (not shown) configured to movably couple branch stent graft 930 to engagement portion 968 of fenestration body 960. Since the engagement portion of branch stent graft 930 is movably coupled to engagement portion 968 of fenestration body 960, branch stent graft 930 may move, pivot, and / or rotate relative to fenestration body 960, as shown in FIG. Figures 11A-11C Specifically, Fig.11A As shown, the branch stent graft 930 can be configured in a first position relative to the window body 960, so that the central axis of the branch stent graft 930 is perpendicular to the central axis of the window body 960. The branch stent graft 930 can be moved relative to the window body 960, so that the branch stent graft 930 is in a second position relative to the window body 960, as shown in FIG. Fig. 11B The branch stent graft 930 can be shifted relative to the window body 960 to a third position relative to the main stent graft 960, as shown in FIG. Fig. 11C In addition, the engagement between the engagement portion of the branch stent graft 930 and the engagement portion 968 of the fenestration body 960 can limit or prevent axial movement of the branch stent graft 930 relative to the fenestration body 960 .

[0077] In some embodiments, the junction portion of the branch stent graft can be formed in any suitable shape. For example, Fig.121 is a schematic diagram of a cross-sectional side view of a system 1000, which includes a branch stent graft 1030 and a window 1060. The branch stent graft 1030 can be any suitable stent, such as a bridge stent or a FEVAR stent. The window 1060 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. The window 1060 can have the same or similar structure and / or function as any other window or stent graft described herein (e.g., stent graft 160 or stent graft 260). The window 1060 can define a window 1065 and include a joint portion 1068 surrounding the window 1065. The joint portion 1068 can be configured to be coupled to the branch stent graft 1030. In some embodiments, the joint portion 1068 includes a reinforcement and / or marking edge of the wall of the window 1060 in the area surrounding the window 1065. In other embodiments, the engagement portion 1068 comprises a wall of the open window body 1060 in the area surrounding the window 1065 and is not reinforced.

[0078] Branch stent graft 1030 may include saddle-shaped engagement portion 1031. Saddle-shaped engagement portion 1031 is configured to be movably coupled to engagement portion 1068 of window body 1060. In some embodiments, branch stent graft 1030 may be self-expanding. For example, saddle-shaped engagement portion 1031 may be foldable and have an offset expanded shape so that branch stent graft 1030 may be folded for delivery and insertion through window 1065. When positioned within window 1065 such that saddle-shaped engagement portion 1031 is aligned with engagement portion 1068 of window body 1060, saddle-shaped engagement portion 1031 may be deployed such that saddle-shaped engagement portion 1031 automatically assumes an expanded configuration and engages with engagement portion 1068 of window body 1060, as shown in FIG. Fig.12 shown.

[0079] In other embodiments, the joint portion 1031 or the entire branch stent graft 1030 can be moldable and radially expandable. After the branch stent graft 1030 has been delivered to the target position relative to the joint portion 1068 of the open window body 1060, a separate expandable member (e.g., a balloon) can be used to expand and / or shape the branch stent graft 1030. The expandable member can be expanded so that the joint portion 1031 of the branch stent graft 1030 is shaped via the force applied by the expandable member to the inner surface of the joint portion 1031. In some embodiments, the expandable member can be preformed so that the unconstrained expansion shape of the expandable member includes two larger diameter portions separated by a smaller diameter portion (e.g., an hourglass shape). The preformed expandable member can apply pressure to the inner surface of the joint portion 1031 so that the joint portion 1031 adopts a similar shape. In other embodiments, the expandable member may have an unconstrained cylindrical expansion shape, and the expandable member may be limited in expansion by the joint portion 1068 of the fenestrated body 1060, so that the expandable member can only expand on either side of the joint portion 1068. As a result, the expandable member can only apply an expansion force to the inner surface of the joint portion 1031 on either side of the joint portion 1068, so that the joint portion 1031 of the branch stent graft 1030 is shaped as follows: Fig.12 The expandable member may be compliant or non-compliant.

[0080] In some embodiments, the system 1000 may include a stop feature so that a user can determine when the joint portion 1031 of the branch stent graft 1030 and the joint portion 1068 of the fenestration body 1060 are properly aligned for deployment and / or expansion of the joint portion 1031. The stop feature can be located on a delivery device for delivering the branch stent graft 1030, on the joint portion 1068, and / or on the joint portion 1031. In some embodiments, the stop feature can be located on an expandable member (e.g., a balloon) that is used to expand and / or shape the branch stent graft 1030. For example, when the expandable member is in a first expanded configuration, the stop feature can engage an anatomical feature (e.g., an aortic wall) to alert the user that the expandable member is correctly positioned. The expandable member can then be moved to a second expanded configuration to apply pressure to the inner surface of the joint portion 1031 so that the joint portion 1031 is forced into a desired shape. In some embodiments, radiopaque markers (eg, strips) may be placed on the branch stent graft 1030 and / or the engagement portion 1068 so that the relative positions of the branch stent graft 1030 and the engagement portion 1068 may be visually confirmed prior to deploying and / or expanding the engagement portion 1031 .

[0081] When the saddle-shaped engagement portion 1031 engages the engagement portion 1068 of the fenestration body 1060, the branch stent graft 1030 may be pivotally or rotationally moved relative to the engagement portion 1068 of the fenestration body 1060. The saddle-shaped engagement portion 1031 may include a flared distal end to limit or prevent axial movement of the branch stent graft 1030 relative to the fenestration body 1060 while still allowing movement (e.g., pivoting, rotating, etc.) relative to the fenestration body 1060.

[0082] In some embodiments, the saddle-shaped engagement portion of the branch stent graft can have any suitable shape. For example, Fig.13A 1 is a schematic diagram of a cross-sectional side view of a system 1100, which includes a branch stent graft 1130 and a fenestration 1160. The branch stent graft 1130 can be any suitable stent, such as a bridge stent or a FEVAR stent. The fenestration 1160 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. The fenestration 1160 can have the same or similar structure and / or function as any other fenestration or stent graft described herein (e.g., stent graft 160 or stent graft 260). The fenestration 1160 can define a window 1165 and include a joint portion 1168 surrounding the window 1165. The joint portion 1168 can be configured to be coupled to the branch stent graft 1130. In some embodiments, the joint portion 1168 includes a reinforcement and / or marking edge of the wall of the fenestration 1160 in the area surrounding the window 1165. In other embodiments, the engagement portion 1168 comprises a wall of the open window body 1160 in the area surrounding the window 1165 but is not reinforced.

[0083] Branch stent graft 1130 may include a saddle-shaped or hourglass-shaped engagement portion 1131. Saddle-shaped engagement portion 1131 is configured to be rotatably coupled to engagement portion 1168 of fenestrated body 1160. In such a configuration, branch stent graft 1130 may move relative to engagement portion 1168 of fenestrated body 1160.

[0084] In some embodiments, the engagement portion 1131 may be moldable and an expandable member may be used to shape the engagement portion 1131. Fig.13AAs shown, the 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 branch stent graft 1130 and the engagement portion 1168 of the open window body 1160. The expandable member 1140 may then be expanded, for example, using a fluid supply mechanism coupled to the expandable member, so that the force applied to the inner surface of the engagement portion 1131 via the expandable member 1140 shapes the engagement portion 1131 of the branch stent graft 1130.

[0085] In some embodiments, the expandable member 1140 can be preformed so that the unconstrained expanded shape of the expandable member 1140 includes a first portion proximal to the open window 1160 and a second portion 1144 distal to the window 1160. The proximal portion also includes a first large diameter portion 1141, a second smaller diameter portion 1142 distal to the first large diameter portion 1141, and a third larger diameter portion 1143 distal to the second smaller diameter portion 1142, as shown in FIG. Fig.13A 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 portion 1141 can be comparable to, slightly larger than, or slightly smaller than the third diameter of portion 1143. The second small diameter portion 1142 forms a valley that engages with the engagement portion 1168 of the window body 1160.

[0086] The distal portion 1144 of the expandable member 1140 can be configured to have a smaller diameter than the proximal portion including the saddle shape. In addition, the distal portion 1140 can be configured to engage with the tail 1136 of the branch stent graft 1130 by applying an expansion force to the inner side of the branch stent graft when expanded. Therefore, the distal portion 1144 of the preformed expandable member 1140 can cause the tail 1136 of the branch stent graft 1130 to adopt a desired shape. Similarly, the proximal portion of the expandable member 1140 can apply an expansion force to the inner side of the proximal region of the branch stent graft 1130 to cause the branch stent graft to assume 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 can be fluidly coupled to a single fluid supply mechanism or individually connected to different fluid supply mechanisms to control their expansion during deployment. The preformed expandable member 1140 can be used to apply pressure to the inner surface of the engagement portion 1131 so that the engagement portion 1131 adopts a similar shape.

[0088] In some embodiments, the expandable member 1140 may 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 forming a saddle shape) may be semi-compliant, while the distal portion of the expandable member 1140 may be non-compliant. In some embodiments, both the proximal portion and the distal portion may be compliant, with the proximal portion having greater compliance than the distal portion of the expandable member 1140. In some embodiments, the distal portion may have substantially equivalent compliance to or greater compliance than the proximal portion of the expandable member 1140.

[0089] As mentioned above, instead of Fig.12 Unlike the illustrated saddle-shaped engagement portion 1031, which includes a flared proximal end when fully expanded, the saddle-shaped 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 so that the two larger diameter portions prevent the branch stent graft 1130 from axially moving away from the main stent graft 1160 while still allowing rotational movement 1160 relative to the main stent graft.

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

[0091] In some other embodiments, the first and third portions of the saddle-shaped engagement portion 1131 may have substantially equal diameters when fully expanded, while the second portion has a smaller diameter and engages with the fenestration body 1160 to prevent axial movement of the branch stent graft 1130 while allowing pivotal or rotational movement of the branch stent graft about the fenestration body 1160.

[0092] In some embodiments, the saddle-shaped engagement portion of the branch stent graft 1130 and the engagement portion 1168 of the fenestrated body 1160 can be configured such that when deployed, the distal portion of the branch stent 1130 (including, for example, the third diameter portion of the saddle-shaped engagement portion 1131) is disposed outside the fenestrated body 1160, while the proximal portion of the branch stent (including, for example, the first diameter portion of the saddle-shaped engagement portion 1131) is disposed inside the fenestrated body 1160. In addition, the intermediate portion (e.g., the second diameter portion of the saddle-shaped engagement portion 1131 forming the valley) can be configured to engage with the opening or window in the engagement portion of the fenestrated body 1160 by frictional engagement or by interference fit.

[0093] In some embodiments, rather than using an expandable member, saddle-shaped engagement portion 1131 may be foldable and have an offset expanded shape so that branch stent graft 1130 may be folded for delivery and insertion through window 1165. When saddle-shaped engagement portion 1131 is positioned within window 1165 so that saddle-shaped engagement portion 1131 is aligned with engagement portion 1168 of open window body 1160, saddle-shaped engagement portion 1131 may be deployed so that saddle-shaped engagement portion 1131 assumes an expanded configuration (e.g., Fig. 13B The configuration shown in ) and engages with the engaging portion 1168 of the open window body 1160.

[0094] In some embodiments, the system 1100 may include a stop feature so that a user can determine when the engagement portion 1131 of the branch stent graft 1130 and the engagement portion 1168 of the fenestration body 1160 are properly aligned for deployment and / or expansion of the engagement portion 1131. The stop feature may be located on a delivery device used to deliver the branch 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., an aortic wall) so as to alert the user 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 so that the engagement portion 1131 is forced into a desired shape. In some embodiments, radiopaque markers (e.g., strips) may be placed on the branch stent graft 1130 and / or the junction portion 1168 so that the relative positions of the branch stent graft 1130 and the junction portion 1168 may be visually confirmed prior to deploying and / or expanding the junction portion 1131.

[0095] As mentioned above, Fig.14 The system 1300 in the embodiment can be substantially similar to other systems described herein. For example, the system 1300 can be similar to Figure 6system 500 shown in FIG. Figure 7 system 600 shown in FIG. Fig.10 . As an example, the branch stent graft 1130 can be substantially similar to the branch stent 630, and the fenestration body 1160 can be substantially similar to the fenestration body 660. In addition, the engagement portion 1131 of the branch stent 1130 can be appropriately rigid or flexible to engage with the fenestration body 1160 at the engagement portion 1168. The engagement portion 1131 of the branch stent 1130 can include a transition portion 1133 and a distal tail 1136 that defines a longitudinal center axis. In addition, the branch stent 1130 can be appropriately flexible or rigid to couple with the fenestration body 1160 and maintain the longitudinal center axis substantially perpendicular to the plane defined by the opening in the fenestration body 1160.

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

[0097] In some embodiments, the tail 1136 of the branch stent graft 1130 may include a covering 1138 made of a suitable material of suitable thickness and having strain capacity to impart the desired flexibility to the branch stent 1130 and allow the branch stent graft to expand. For example, the covering 1138 may be formed of one or more layers of suitable material with a suitable microstructure so that the flexibility of the branch stent graft 1130 can be precisely controlled. As an example, the covering 1138 may be configured to have strain capacity to support the branch stent from a first diameter size (e.g., about 2 mm) to a second substantially expanded diameter size (e.g., about 4-12 mm) without failure. That is, the strain capacity of the covering 1138 may be designed to withstand branch stent expansion within an example range of 2 mm-4 mm to 2 mm-12 mm. In some embodiments, the covering may have a strain capacity 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 above-mentioned covering 1138 may be disposed on the flexible tail 1136, the joint portion 1131, the transition portion, or any combination thereof. In other words, the covering may be disposed on any individual portion, multiple portions, or the entire branch stent graft 1130 of the branch stent graft 1130. In addition, the covering 1138 disposed over the joint portion 1131, the transition portion 1133, and / or the tail 1136 of the branch stent graft 1130 may be configured to impart the desired flexibility to each of the joint portion, the transition portion, and the tail of the branch stent 1130. For example, the covering disposed on one or more of the above-mentioned portions may be a suitable material with a suitable microstructure, and may be made of a suitable thickness with a suitable number of layers to provide the desired flexibility through substantially precise control.

[0099] The transition portion of the branch stent 1130 can be appropriately flexible or rigid to prevent any kink formation or structural fatigue between the window body 1160 and the branch stent 1130. For example, in some embodiments, the flexibility of the transition portion 1133 of the branch stent 1130 can be greater than the flexibility of the joint portion 1131 and less than the flexibility of the flexible tail portion of the branch stent 1130. In other words, the tail portion 1136 can be configured to be substantially more flexible than the transition portion 1133 and the joint portion 1131. For example, the flexibility of the tail portion 1136 of the branch stent 1130 can be configured such that when a deflection force of less than 1N is used, the branch stent 1130 deflects from its longitudinal axis by at least about 1 mm, at least about 2 mm, at least about 3 mm, or at least about 4 mm at a longitudinal distance of 20 mm from the joint portion 1131 of the branch stent. In other words, the flexible tail defines a longitudinal center axis in a first unstressed 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 joint 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 joint portion 1131 and / or the tail of the branch stent 1130.

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

[0101] Branch stent graft 1330 may include engagement portion 1331. Engagement portion 1331 may include first larger diameter portion 1331A and second larger diameter portion 1331B. Engagement portion 1331 may be coupled to engagement portion 1368 of fenestration body 1360 such that engagement portion 1368 of fenestration body 1360 is positioned between first larger diameter portion 1331A and second larger diameter portion 1331B. Thus, branch stent graft 1330 may move relative to engagement portion 1368 of fenestration body 1360. First larger diameter portion 1331A and second larger diameter portion 1331B may each have a larger diameter than a diameter of window 1365 defined by engagement portion 1368 of fenestration body 1360, thereby limiting or preventing axial movement of branch stent graft 1330 relative to main stent graft 1360 while still allowing rotational and / or pivotal movement relative to 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 may be the same size or larger in size than the second larger diameter portion 1331B.

[0102] Fig.1514 is a schematic diagram of a cross-sectional side view of system 1400. System 1400 includes a branch stent graft 1430 having a bilateral engagement portion 1431. System 1400 also includes a window 1460. Branch stent graft 1430 can be any suitable stent, such as a bridge stent or a FEVAR stent. The window 1460 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. The window 1460 can have the same or similar structure and / or function as any other window or stent graft described herein (e.g., stent graft 160 or stent graft 260). The window 1460 can define a window 1465 and include an engagement portion 1468 surrounding the window 1465. The engagement portion 1468 can be configured to couple to the branch stent graft 1430. In some embodiments, the engagement portion 1468 includes a reinforcing and / or marking edge of the wall of the window 1460 in the area surrounding the window 1465. In other embodiments, the engagement portion 1468 includes the walls of the fenestration body 1460 in the area 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 fenestration 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 therefore 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 interior and / or exterior of the fenestration body 1460. For example, in some embodiments, the first engagement feature 1431A and the second engagement feature 1431B can be configured and attached to the fenestration body 1460 in a manner similar to a patent foramen ovale (PFO) closure device with an attached stent.

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

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

[0106] In some embodiments, the branch stent graft may include an anchoring member for engaging with an inner wall of the fenestration (e.g., the main stent graft or a vessel wall). Figures 16A-16E1 is a schematic diagram of various views and configurations of system 1500. System 1500 includes a branch stent graft 1530, which includes an anchoring member 1550 and a window 1560. Branch stent graft 1530 can be any suitable stent, such as a bridge stent or a FEVAR stent. The window 1560 can be, for example, a vessel wall or a main stent graft, such as an aortic stent graft. The window 1560 can have the same or similar structure and / or function as any other window or stent graft described herein (e.g., stent graft 160 or stent graft 260). The window 1560 can define a window 1565 and include a joint portion 1568 surrounding the window 1565. The joint portion 1568 can be configured to be coupled to the branch stent graft 1530. In some embodiments, the joint portion 1568 includes a reinforcement and / or marking edge of the wall of the window 1560 in the area surrounding the window 1565. In other embodiments, the engagement portion 1568 comprises a wall of the open window body 1560 in the area surrounding the window 1565 but is not reinforced.

[0107] The anchoring member 1550 can be in the form of a parachute or flared end of the branched stent graft 1530. The anchoring member 1550 can be moved from a collapsed delivery configuration to an expanded anchoring configuration. Fig.16A (which is a schematic diagram of a cross-sectional side view of the system 1500 in a first configuration), the anchoring member 1550 can be delivered to the window 1565 in a collapsed 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 so 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. Fig. 16B (which is a schematic diagram of a cross-sectional side view of the system 1500 in the second configuration), the anchoring member 1550 can be expanded to the expanded anchoring configuration after delivery, for example, from the end of a 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 window body 1560 so that the anchoring member 1550 engages with the engagement portion 1568 of the window body 1560 (e.g., so that the anchoring member 1550 is adjacent to the engagement portion 1568), as shown. Fig. 16C In such a configuration, branch stent graft 1530 may be positioned such that branch stent graft 1530 extends through window 1565 but cannot move axially relative to window 1530. Fig.16D As shown, once anchor member 1550 is positioned in engaged relationship with engagement portion 1568, branch stent graft 1530 can be expanded, for example, via an expandable member (eg, a balloon) within window 1565. Fig.16Eis a schematic diagram of the inner wall of a fenestration 1560 with an anchoring member 1550 secured to an engagement portion 1568 of the fenestration 1560. In some embodiments, the anchoring member 1550 and the branched stent graft 1530 may be attached to the fenestration in a manner similar to a patent foramen ovale (PFO) closure device with an attached stent.

[0108] although Figures 16A-16E Only one anchoring member 1550 is shown in the figure, but in some embodiments, a second anchoring member may be included so that the second anchoring member engages the outer wall of the fenestration body 1560. For example, a self-expanding parachute may be provided on the branch stent graft 1530 so that the first self-expanding parachute may be opened on the inner side of the fenestration body 1560 and the second self-expanding parachute may be opened on the outer side of the fenestration body 1560, thereby fixing the branch stent graft 1530 to the fenestration body 1560.

[0109] In use, as described above, the branch stent graft 1530 can be delivered to the target location using a deployment device. For example, the branch stent graft 1530 can be passed through the window 1560 through a guidewire and delivered from the window 1565 of the window 1560 to the branch artery ( Figures 16A-16E In some embodiments, a delivery tube may be used to position branch stent graft 1530 such that anchoring member 1550 is within the lumen of fenestration body 1560 and another portion of branch stent graft 1530 is within the branch artery (similar to Fig.16A In this position, you can (similar to Fig. 16B ) deploys anchoring member 1550 (e.g., a parachute). For example, anchoring member 1550 or the entire branch stent graft 1530 can be pushed out of one end of a delivery tube and automatically expand to Fig. 16B The anchoring member 1550 can then be pushed toward the window 1530 so that the anchoring member 1550 abuts against the area of ​​the window opening surrounding the window (e.g., Fig. 16C With the anchoring member abutting the fenestration wall and / or the engagement portion, branched stent graft 1530 may be axially expandable within fenestration 1565 and the branch artery (e.g., Fig.16D 1565). For example, an expandable member (eg, a balloon) can be inserted into the annulus of branch stent graft 1530 and expanded, thereby expanding branch stent graft 1530 to a wider diameter configuration within window 1565.

[0110] Although various embodiments of the systems, methods and devices have been described above, it should be understood that they are presented by way of example only, and not by way of limitation. Where the above methods and steps indicate that certain events occur in a particular order, those of ordinary skill in the art who benefit from this disclosure will recognize that the order of certain steps may be modified and that these modifications are consistent with variations of the present invention. In addition, certain steps may be performed simultaneously with 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 may be made in form and detail.

[0111] For example, although various embodiments have been described as having specific features and / or combinations of components, other embodiments may have any combination or partial combination of any features and / or components from any embodiment described herein. In addition, the specific configuration of the various components may also be changed. For example, the size and specific shape of the various components may be different from the illustrated embodiment while still providing the functionality as described herein.

Claims

1. A radially expandable branched stent graft, comprising: A coupling portion, which is used to couple with the opening in the window body, the coupling portion includes a proximal portion (1141) having a first diameter, a middle portion (1142) having a second diameter, and a distal portion (1143) having a third diameter, the proximal portion is configured to be arranged inside the window body (1160), and the distal portion is configured to be arranged outside the window body (1160), and the second diameter is smaller than the first diameter and the third diameter when the coupling portion (1131) is in an expanded state, the coupling portion is configured to allow the branch stent graft to pivot around the opening of the window body and rotate relative to the window body around the opening of the window body while maintaining a perpendicular angle between the longitudinal center axis of the window body and the plane of the coupling portion, and to limit the axial movement of the branch stent graft relative to the window body; and a flexible tail extending from the engagement portion, and The branched stent graft comprises portions having different flexibility or rigidity.

2. The branch stent graft of claim 1, wherein the intermediate portion is configured to frictionally engage the opening of the fenestrated body.

3. The branched stent graft of claim 1, wherein the engagement portion is rigid. The branched stent graft of claim 1 , wherein the engagement portion is flexible.

5. The branch stent graft of claim 1 , wherein the branch stent graft further comprises a transition portion between the engagement portion and the flexible tail, the engagement portion and the transition portion defining the longitudinal center axis, the engagement portion being configured to maintain the longitudinal center axis substantially perpendicular to a plane defined by the opening in the fenestration body.

6. The branch stent graft of claim 1 further comprising a transition portion between the engagement portion and the flexible tail portion, wherein the transition portion is rigid.

7. The branch stent graft of claim 1, further comprising a transition portion between the engagement portion and the flexible tail, wherein the transition portion is flexible.

8. The branched stent graft of claim 1, wherein the flexibility of the flexible tail is imparted by at least one of a stent pattern, a stent thickness, and a stent material.

9. The branch stent graft of claim 1, wherein at least a portion of the flexible tail has a covering.

10. The branch stent graft of claim 9, wherein the flexibility of the flexible tail is controlled by at least one of a covering thickness, a covering material, a covering microstructure, and a number of covering layers.

11. The branch stent graft of claim 9, wherein the covering has a strain capacity of at least five times the diameter expansion of the engagement portion.

12. The branched stent graft of claim 1, wherein the flexible tail portion has at least 25% greater flexibility than the engagement portion.

13. The branch stent graft of claim 1, wherein the flexible tail defines a longitudinal central axis in a first state, the flexible tail being configured to deflect from the first state to a second state when a deflection force of less than 1 N is applied.

14. The branch stent graft of claim 13, wherein the flexible tail is configured to move at least 3 mm at a longitudinal distance of 20 mm from the engagement portion.

15. A radially expandable branched stent graft, comprising: a saddle-shaped engagement portion for engaging with an opening in a fenestrated body, the saddle-shaped engagement portion comprising a proximal portion configured to be disposed inside the fenestrated body, a distal portion configured to be disposed outside the fenestrated body, and a middle portion configured to frictionally engage with the opening of the fenestrated body, the branch stent graft being configured to pivot about the opening of the fenestrated body and rotate about the opening of the fenestrated body while maintaining a perpendicular angle between a longitudinal center axis of the fenestrated body and a plane of the saddle-shaped engagement portion, wherein the proximal portion has a first diameter, the middle portion has a second diameter, and the distal portion has a third diameter, the second diameter being smaller than the first diameter and the third diameter in an expanded state; and a flexible tail portion extending from the saddle-shaped engaging portion, and The branched stent graft comprises portions having different flexibility or rigidity.

16. The branched stent graft of claim 15, wherein the first diameter is substantially equal to the third diameter in an expanded state.

17. The branch stent graft of claim 15, wherein the saddle-shaped engagement portion is configured to allow the branch stent graft to pivot about the opening of the fenestrated body.

18. The branch stent graft of claim 15, wherein the saddle-shaped engagement portion is configured to limit axial movement of the branch stent graft relative to the fenestrated body.

19. The branched stent graft of claim 15, wherein the flexible tail portion is at least 25% more flexible than the saddle-shaped engagement portion.

20. The branch stent graft of claim 15, further comprising a transition portion between the saddle-shaped engagement portion and the flexible tail, wherein the saddle-shaped engagement portion, the transition portion, and the flexible tail comprise a covering disposed on a stent structure.

21. The branch stent graft of claim 20, wherein properties of the covering at least partially determine the flexibility of the saddle engagement portion, the transition portion, and the flexible tail.

22. The branch stent graft of claim 21, wherein the characteristic comprises at least one of covering thickness, covering material, covering microstructure, and number of covering layers.

23. A system for treating an aneurysm, comprising: a fenestrated stent graft comprising openings corresponding to branch vessels; a radially expandable branch stent-graft configured to couple to an opening in the fenestrated stent-graft, the branch stent-graft comprising an engagement portion for engaging with the opening in the fenestrated stent-graft and a flexible tail extending from the engagement portion, the branch stent-graft configured to pivot about the opening of the fenestrated stent-graft and to rotate about the opening of the fenestrated stent-graft while maintaining a perpendicular angle between a longitudinal center axis of the fenestrated stent-graft and a plane of the engagement portion, and wherein the branch stent-graft comprises portions having different flexibility or rigidity; as well as An expandable member configured to transition a radially expandable branched stent graft from a collapsed configuration to an expanded configuration, the expandable member including a proximal portion having a first diameter and a distal portion having a second diameter that is smaller than the first diameter.

24. The system of claim 23, wherein the expandable member is semi-compliant.

25. The system of claim 23, wherein a proximal portion of the expandable member is semi-compliant and a distal portion of the expandable member is non-compliant.

26. The system of claim 23, wherein both the proximal portion and the distal portion of the expandable member are fluidly coupled to a single fluid supply mechanism.

27. The system of claim 23, wherein the proximal portion of the expandable member has a first compliance and the distal portion of the expandable member has a second compliance, the first compliance being greater than the second compliance.

28. The system of claim 23, wherein the expandable member has an hourglass shape in the expanded configuration.

29. The system of claim 23, wherein the expandable member has a radiopaque marker configured to align with the opening in the fenestrated stent graft.

30. The system of claim 23, wherein a proximal portion of the expandable member is non-compliant and a distal portion of the expandable member is semi-compliant.

31. The system of claim 23, further comprising a transition portion between the engagement portion and the flexible tail, wherein the transition portion is rigid.

32. The system of claim 23, further comprising a transition portion between the engagement portion and the flexible tail, wherein the transition portion is flexible.

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