Graft system

Abstract

A graft system comprising: a graft body having an incision or opening in a side surface through which a support structure is insertable; and a filling structure surrounding at least part of the graft body, defining an internal volume fillable with a filling medium, and having a conduit through which the support structure is insertable, the filling structure comprising: a baffle configured to be fillable with a filling medium, and a window having a width greater than the width of the support structure, and partially opening the graft body prior to filling the baffle with the filling medium; and when the support structure is disposed within the window, the baffle expanded by filling with the filling medium reaches an outer surface of the support structure to form the duct; and when the support structure is not disposed within the window, a baffle expanded by filling with a filling medium completely seals the window.

Description

[0001] This application is a divisional application of the application filed by Endorojacks LLC, filed on December 23, 2016, with application number 201680082677.1, entitled "System and Method with Windowed Graft and Filling Structure". Technical Field

[0002] Embodiments of the present invention generally relate to vascular prostheses (artificial blood vessels) and methods of placing such prostheses, and in one application, to vascular prostheses used in the treatment of branching blood vessels. Background Technology

[0003] An abdominal aortic aneurysm is a sac formed by the abnormal expansion of the wall of the aorta (the body's main artery) as it passes through the abdomen. The abdomen is the region of the body located between the chest and pelvis. It contains a cavity (called the abdominal cavity), which is separated from the thoracic cavity by a diaphragm and lined with a serosal membrane (i.e., the peritoneum). The aorta is the main trunk or artery from which the entire arterial system originates. The aorta originates from the left ventricle of the heart, ascends, bends, and descends through the chest and abdomen to the level of the fourth lumbar vertebra, where it divides into the two common iliac arteries.

[0004] Aneurysms typically occur in the lower portion of the aorta below the kidney, such as just below the kidney. If left untreated, an aneurysm can eventually rupture, leading to fatal bleeding within a very short time. The high mortality rate associated with rupture initially led to abdominal surgical repair of abdominal aortic aneurysms. However, surgery involving the abdominal wall is a significant and inherently high-risk procedure.

[0005] Recently, a significantly minimally invasive clinical approach to aneurysm repair, called endovascular grafting, has been developed, involving the transluminal placement of a prosthetic arterial graft at an intraluminal location (within the arterial lumen). In this method, the graft is attached to the inner surface of the arterial wall using attachment devices (expandable stents), such as a stent located above the aneurysm and a second stent located below the aneurysm.

[0006] In some cases, the diseased area of ​​a blood vessel extends through its branch vessels. The blood flowing into these branch vessels is crucial for perfusion of the peripheral region and vital organs. Many arteries branch off from the aorta. For example, the carotid arteries supply blood to the brain, the renal arteries to the kidneys, the superior mesenteric artery (“SMA”) to the pancreas, the internal iliac arteries to the reproductive organs, and the subclavian artery to the arm. When the aorta is diseased, its branch vessels may also be affected. A thoracic aortic aneurysm may involve the subclavian and carotid arteries, while an abdominal aortic aneurysm may involve the SMA, renal arteries, and internal iliac arteries. An aortic dissection can involve all of these branch vessels. Summary of the Invention

[0007] A system according to one embodiment includes a graft body and a filling structure. The graft body has a fenestration in a side surface through which a support structure can be inserted. The filling structure has an internal volume that can be filled with a filling medium and is configured to have a conduit through which the support structure can be inserted. In various embodiments, the fenestration in the graft body is aligned with the conduit in the filling structure such that the support structure can pass through both the fenestration in the graft body and the conduit in the filling structure.

[0008] According to one aspect of this application, a graft system is provided, comprising: a graft body having a cut or opening in a side surface, through which a support structure can be inserted; and a filling structure defining an internal volume that can be filled with a filling medium around at least a portion of the graft body and having a conduit through the internal volume, wherein the support structure can be inserted through the conduit, wherein the filling structure includes: a baffle configured to be filled with the filling medium; and a window having a width greater than the width of the support structure and partially opening the graft body before the baffle is filled with the filling medium; and when the support structure is disposed within the window, the baffle, which expands upon being filled with the filling medium, reaches an outer surface of the support structure to form the conduit; and when the support structure is not disposed within the window, the baffle, which expands upon being filled with the filling medium, completely seals the window.

[0009] According to one embodiment, the conduit in the filling structure can be aligned with the incision or opening in the graft body, so that the support structure can be inserted through both the conduit in the filling structure and the incision or opening in the graft body.

[0010] According to one embodiment, the incision or opening in the graft body and the conduit in the filling structure can be aligned with the renal artery.

[0011] According to one embodiment, the graft system further includes a support attached to the graft body at a location entirely above the incision or opening in the graft body.

[0012] According to one embodiment, the graft body is configured to have an augmentation portion having loose graft material to allow the incision or opening to be moved to align the incision or opening with an artery.

[0013] According to one embodiment, the filling structure is configured to have a plurality of pipes positioned along the length of the filling structure.

[0014] According to one embodiment, the filling structure is configured such that each of the plurality of pipes can collapse when the filling structure is filled with the filling medium.

[0015] According to another aspect of this application, a graft system is provided, comprising: a graft body having a cut or opening in a side surface; a support structure insertable through the cut or opening; a filling structure defining an internal volume that can be filled with a filling medium around at least a portion of the graft body and having a conduit through the internal volume, wherein the support structure is insertable through the conduit; and a window, wherein the filling structure includes a baffle configured to be filled with the filling medium, and wherein, when filled, the baffle expands to fill the window to a corresponding side of the support structure.

[0016] According to one embodiment, the baffle is excessively large relative to the window.

[0017] According to one embodiment, the baffle is in fluid communication with the internal volume of the filling structure. Attached Figure Description

[0018] Figure 1 This is a partial cross-sectional view of the patient's vascular system, illustrating an embodiment of an intraluminal prosthesis deployed in a desired location within the patient's vascular system.

[0019] Figure 2 yes Figure 1 The diagram shown is a front perspective view of the intracavitary prosthesis.

[0020] Figure 3 It is along Figure 1The image shows a cross-sectional view of an embodiment of an intracavitary prosthesis arranged in the patient's anatomy, taken from line 3-3.

[0021] Figure 4 This is a schematic diagram of an embodiment of an intraluminal prosthesis located within an artery with a deployment catheter.

[0022] Figure 5 This is a schematic diagram of an embodiment of an intraluminal prosthesis placed in a desired location within an artery, close to a target branch artery.

[0023] Figure 6 This is a schematic diagram of one embodiment of an endovascular prosthesis having a pre-cannulated guidewire positioned close to a target branch artery.

[0024] Figure 7 This is a schematic diagram of one embodiment of an intraluminal prosthesis having a pre-bent angiography catheter that tracks a pre-inserted guidewire.

[0025] Figure 8 This is a schematic diagram of one embodiment of an endovascular prosthesis having a stent positioned within a target branch artery.

[0026] Figure 9 This is a schematic diagram of one embodiment of an endovascular prosthesis having a stent that expands within a target branch artery and a filling structure partially supported by an inflatable balloon.

[0027] Figure 10 This is a schematic diagram of one embodiment of an intracavitary prosthesis having a filling tube for delivering a hardenable filling medium to a filling structure.

[0028] Figure 11 This is a schematic diagram of one embodiment of an intracavitary prosthesis having a fully inflatable filling structure.

[0029] Figure 12 This is a three-dimensional view of another embodiment of an intracavitary prosthesis.

[0030] Figure 13A This is a cross-sectional view of an embodiment of an intracavitary prosthesis placed within the patient's anatomical structure.

[0031] Figure 13B This is a cross-sectional view of an embodiment of an intracavitary prosthesis placed within the patient's anatomical structure.

[0032] Figure 14This is a partial sectional view of the patient's vascular system, showing another embodiment of an intraluminal prosthesis in the patient's anatomy, the intraluminal prosthesis comprising a filling structure with multiple channels.

[0033] Figure 15 It has Figure 14 A perspective view illustrating the filling structure of multiple pipes in an embodiment.

[0034] Figure 16 This is a partial cross-sectional view of another embodiment of an intracavitary prosthesis arranged in the patient's anatomy, the intracavitary prosthesis comprising multiple horizontal filling structures.

[0035] Figure 17 This is a three-dimensional view of a support structure extending between two horizontally filled structures in their unexpanded state.

[0036] Figure 18 This is a three-dimensional view of a support structure extending between two horizontally filled structures in an expanded state.

[0037] Figure 19 This is a partial cross-sectional view of the patient's vascular system, illustrating another embodiment of an intracavitary prosthesis positioned at a desired location within the patient's vascular system.

[0038] Figure 20 yes Figure 19 A schematic front perspective view of an embodiment of the intracavitary prosthesis shown.

[0039] Figure 21 It is along Figure 19 The cross-sectional view of an embodiment of an intracavitary prosthesis arranged in the patient's anatomical structure, taken by line 21-21.

[0040] Figure 22 This is a schematic representation of an embodiment of an intraluminal prosthesis positioned within an artery with a deployment catheter.

[0041] Figure 23 This is a schematic representation of an embodiment of an intraluminal prosthesis placed in a desired location within an artery, close to a target branch artery.

[0042] Figure 24 This is a schematic representation of one embodiment of an endovascular prosthesis having a pre-cannulated guidewire positioned close to a target branch artery.

[0043] Figure 25 This is a schematic representation of an embodiment of an intraluminal prosthesis having a pre-bent angiography catheter that follows a pre-inserted guidewire.

[0044] Figure 26This is a schematic representation of one embodiment of an endovascular prosthesis having a stent positioned within a target branch artery.

[0045] Figure 27 This is a schematic representation of one embodiment of an endovascular prosthesis having a stent that expands within a target branch artery and a filling structure partially supported by an inflatable balloon.

[0046] Figure 28 This is a schematic representation of one embodiment of an intracavitary prosthesis having a filling tube for delivering a hardenable filling medium to a filling structure.

[0047] Figure 29 This is a schematic representation of one embodiment of an intracavitary prosthesis having a fully inflatable filling structure.

[0048] Figure 30 This is a partial sectional view of the patient's vascular system, showing another embodiment of an intracavitary prosthesis in the patient's anatomy, the intracavitary prosthesis comprising a master graft body having multiple windows. Detailed Implementation

[0049] The following detailed description is now given with reference to certain embodiments of the present disclosure. Reference is made to the accompanying drawings in this specification, wherein similar reference numerals denote similar parts throughout the specification and drawings.

[0050] Certain embodiments described herein relate to systems, methods, and apparatuses for treating injuries, aneurysms, or other defects in the aorta (to name only, including but not limited to the thoracic aorta, ascending aorta, and abdominal aorta). However, these systems, methods, and apparatuses may be applied to other blood vessels or regions of the body, or to other fields, and such additional applications are intended to form part of this disclosure. For example, it should be understood that the systems, methods, and apparatuses may be applied to treat blood vessels in animals. In summary, embodiments and / or schemes of the endovascular prosthesis systems, methods, and apparatuses described herein may be applied to other parts of the body, or may have other applications besides treating the thoracic aorta, ascending aorta, and abdominal aorta. Furthermore, while specific embodiments may be described herein with reference to specific portions of the aorta, it should be understood that the described embodiments may be adapted for use in other portions of the aorta or other parts of the body, and are not limited to the described aortic portions.

[0051] Figure 1This is a partial cross-sectional view of a patient's vascular system, illustrating one embodiment of an endovascular prosthesis positioned at a desired location within the patient's vascular system. While the prostheses disclosed herein are adaptable for placement in any suitable blood vessel within the body, some embodiments are described as placement in a specific blood vessel or vascular region within the patient. However, the specific prosthesis shown is not limited to placement in only one specific blood vessel or vascular region. In some embodiments, the illustrated embodiment may be adaptable for placement in other suitable blood vessels within the patient, including the aorta, thoracic artery, renal artery, iliac artery, etc.

[0052] refer to Figure 1 As an example, one embodiment of the endovascular prosthesis 20 is shown disposed in the patient's aorta 10. For reference, the patient's first renal artery 12a and second renal artery 12b are also shown; the patient's first iliac artery 14a and second iliac artery 14b; the patient's superior mesenteric artery (SMA) 16; and the patient's celiac artery 18 are also shown. A subrenal abdominal aortic aneurysm 11 is also shown between the renal arteries 12a, 12b and the iliac arteries 14a, 14b, and this subrenal abdominal aortic aneurysm may have a mural thrombus region on a portion of its inner surface.

[0053] Figure 2 yes Figure 1 A schematic front perspective view of the intracavitary prosthesis 20 shown. Figure 1 and Figure 2 The embodiment of the intracavitary prosthesis 20 shown includes: a master graft body 22, which includes a first window 24a (e.g., a scallop, incision, opening, etc.) and a second window 24b; a support structure 25; and a double-walled filling structure 26 in the region of the aneurysm 11 (for clarity, in...). Figure 2 (shown in dashed lines); and support structure 28, which extends through windows 24a, 24b and through filler structure 26.

[0054] The endovascular prosthesis 20 is described herein as being positioned within the abdominal aorta 10 near one or more branch arteries, with multiple elements (such as support structure 28) positioned within the branch arteries. In some configurations, the elements may be positioned within any or a combination of the following: the left renal artery, the right renal artery, the second lumbar vertebra, the testis, the inferior mesenteric artery, the middle sacrum, or other vessels branching from the aorta. Thus, in some embodiments, the endovascular prosthesis 20 may include any number of elements required for a particular application, including but not limited to elements for one, two, three, or more branch arteries. Because the elements positioned within the branch arteries can be configured to conform to a variety of vessels and locations, these elements can have any suitable size, shape, or configuration and can be attached to the master graft body 22 at any of a variety of locations.

[0055] The master graft body 22 defines a central lumen 30. The master graft body 22 provides a synthetic vascular wall that guides blood flow through a diseased portion of a blood vessel (e.g., the aorta 10). The intraluminal prosthesis 20 is positioned such that a first window 24a and a second window 24b are each aligned with a branch vessel of the aorta 10. In one embodiment, the first window 24a is aligned with a first renal artery 12a, and the second window 24b is aligned with a second renal artery 12b, such that a fluid path is formed from the central lumen 30 to the first and second renal arteries 12a and 12b. In some embodiments, the master graft body 22 may have a generally cylindrical tubular shape. The intraluminal prosthesis 20 may be formed of any suitable material (e.g., but not limited to, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), and paraxylene).

[0056] Some embodiments of the endovascular prosthesis 20 may be formed of an expandable material. The endovascular prosthesis 20 may be configured such that the master graft body 22 is larger than the target vessel in which the master graft body 22 is to be placed. For example, the target may be the aorta 10, and the endovascular prosthesis 20 may be positioned across an aneurysm 11 in the aorta 10. In some embodiments, the endovascular prosthesis 20 may be positioned such that an augmentation portion 32 of the master graft body 22 is located near the first renal artery 12a and the second renal artery 12b. In the various graft embodiments disclosed herein, the diameter of the graft body (e.g., but not limited to the master graft body 22) or the diameter of the augmentation portion of any embodiment of the graft body disclosed herein may be approximately 30% larger than the diameter of the target vessel or the diameter of the non-augmented portion of the graft body. In some embodiments, the diameter of the graft body (e.g., but not limited to the main graft body 22) or the diameter of the augmented portion of any embodiment of the graft body disclosed herein may be less than about 20% of the diameter of the target blood vessel or the diameter of the non-augmented portion of the graft body, or greater than about 20% to about 50% or more, or greater than about 25% to about 40%, or any value within these ranges.

[0057] In some embodiments, the master graft body 22 may have any of the features of the master graft body disclosed in U.S. Patent Application Serial No. 14 / 581,675 (titled “Fenestrated Prosthesis”), filed December 23, 2014, the entire contents of which are incorporated herein by reference as if fully set forth herein.

[0058] Furthermore, in the various graft embodiments disclosed herein, at least a portion of the graft material adjacent to one or more windows or openings is freely translatable in the circumferential or axial direction relative to the scaffold or other support structure supporting the graft. For example, but not limited to, certain portions (such as end portions of the graft material) may be sutured or otherwise secured to the scaffold, while the intermediate portion of the graft (having one or more windows passing through it) may not be attached to the scaffold, such that the intermediate portion is freely translatable relative to the scaffold, and thus allows adjustment of the windows relative to the scaffold. In this configuration, for example, the windows may be adjusted to align with the ostium of a branch vessel in the patient.

[0059] The excessive diameter of the main graft body 22 (e.g., the augmentation portion 32) can provide excess or slack graft material in the main graft body 22, such that each window 24a and 24b can be moved in an axial or angular direction to align the window 24a and 24b with the branch vessel artery, as will be described in more detail below.

[0060] As described above, two or more windows can be formed at any desired location within the main graft body 22. For example, two windows 24a and 24b can be formed at approximately diametrically opposed locations (see [link to documentation]). Figure 2 However, any number of windows can be formed in the master graft body 22 at any desired location. Additionally, windows can be formed in the distal portion of the master graft body 22 or at any suitable location, with the scalloped opening or incision configured to prevent obstruction of other arteries branching from the main vessel from which the master graft body 22 will be positioned. For example, in some embodiments, additional windows 34 can be formed in the distal portion of the master graft body 22. Window 34 can be formed to align with the patient's SMA 16 and / or celiac artery 18.

[0061] In some embodiments, when the master graft body 22 is in a relaxed state, such as before the graft is placed, at least a portion of the master graft body 22 includes undulations, folds, bends, corrugations, or other similar features in its axial direction. In some embodiments, the intermediate portion of the graft (e.g., the augmentation portion 32) includes undulations, folds, bends, corrugations, or other similar features, while the distal or upstream portion and / or proximal or downstream portion defines a smooth profile. In some embodiments, after the master graft body 22 has been placed in the target blood vessel, since the master graft body 22 may have a diameter larger than the diameter of the blood vessel, folds, wrinkles, or other undulations (collectively referred to as folds) may be formed around the periphery of the master graft body 22.

[0062] In some embodiments, a support structure 25 (which may be, for example, a covered stent, a bare suture, or any other suitable stent or anchoring device) is disposed within the central cavity 30 of the master graft body 22 to secure the graft in the desired position. In various embodiments, the support structure 25 presses the master graft body 22 against the vessel wall or against a filling structure 26 disposed between the master graft body 22 and the vessel wall, and secures the master graft body 22 and the windows 24a, 24b in the desired position. In various embodiments, the support structure 25 is formed of any number of resilient metals such as stainless steel, cobalt-chromium (CoCr), nickel-titanium alloy, or resilient polymer. The support structure 25 may be coupled to an inner or outer surface of the master graft body 22. In some embodiments, the intracavitary prosthesis 20 includes a first portion of the support structure 25 located at the proximal portion of the master graft body 22 and a second portion of the support structure 25 located at the distal portion of the master graft body 22, such that the support structure 25 does not extend through the augmentation portion 32. In some embodiments, the support structure 25 extends through the augmentation portion 32. In various embodiments in which the support structure 25 is disposed in the augmentation portion 32, the window portions 24a, 24b extend through the support structure 25.

[0063] In various embodiments, the filling structure 26 surrounds the master graft body 22 and, upon expansion, occupies an annular space between the master graft body 22 and the wall of the aorta 10. The filling structure 26 defines an internal volume 40 defined between an outer wall 42 and an inner wall 44. The inner wall 44 defines a lumen 46. The lumen 46 is configured to receive the master graft body 22. In various embodiments, the geometry of the filling structure 26 is selected or manufactured to match the geometry of a specific patient to be treated. Upon expansion by filling material or media delivered into the internal volume 40, the outer wall 42 expands radially outward. In some embodiments, the filling structure 26 further includes at least one conduit 48 extending through the internal volume 40 and aligned with a window portion of the master graft body 22. Figure 1 and Figure 2The embodiment shown includes two conduits 48. Each conduit 48 defines a channel 50 separate from the internal volume 40. The channel 50 opens at a first end 52 to the internal cavity 46 and at a second end 54 to the space surrounding the filling structure 26. In some embodiments, the filling structure 26 is attached to the master graft body 22 and / or the support structure 25 with a suture 41 to maintain the desired alignment of each conduit 48 with a corresponding window (e.g., windows 24a, 24b in the master graft body 22). In some embodiments, the filling structure 26 is attached to the master graft body 22 and / or the support structure 25 with an adhesive or other suitable attachment mechanism. In some embodiments, the filling structure 26 is integrally formed with the master graft body 22. For example, in some embodiments, the master graft body 22 forms the inner wall of the filling structure 26.

[0064] In various embodiments, the filling structure 26 includes at least one valve 56 to allow the introduction of filling material or media into the internal volume 40 of the filling structure 26. In some embodiments, the valve 56 includes a simple flap valve. In some embodiments, the valve 56 includes other more complex ball valves or other one-way valve structures. In some embodiments, the valve includes a two-way valve structure to allow the filling and selective evacuation of the internal volume 40. In some embodiments, the filling tube includes a needle or other filling structure to pass through the valve 56, thereby allowing the filling and removal of the filling medium. In some embodiments, radiopaque markers 63 are provided at each window (e.g., window 24a, 24b) to aid in window positioning.

[0065] In some embodiments, the filling structure 26 may have any features of the filling structure disclosed in U.S. Patent Application Serial No. 13 / 285,897, filed October 31, 2011 (titled “Graft Systems Having Filling Structures Supported by Scaffolds and Methods of Their Use”) and now U.S. Patent No. 8,870,941, or any features of the filling structure disclosed in U.S. Patent Application Serial No. 12 / 478,225, filed June 4, 2009 (titled “Sealing Apparatus and Methods of Use”), the entire contents of each of which are incorporated herein by reference as if fully set forth herein.

[0066] Figure 3 Through Figure 1The image shows a cross-sectional view of an embodiment of an intraluminal prosthesis 20 arranged in the patient's anatomy, taken from line 3-3. Each support structure 28 (e.g., a covered stent, a bare suture stent, etc.) extends from the central lumen 30, through corresponding windows 24a and 24b in the master graft body 22, through corresponding conduits 48 in the filling structure 26, and into the corresponding renal arteries 12a, 12b. In various embodiments, the support structure 28 is a stent-like or graft-like vascular structure and is arranged within the lumen using a balloon or other dilatational catheter (in the case of an extendable or balloon-expandable stent) or using a restraint sheath (in the case of a self-expanding stent). In various embodiments, the support structure 28 maintains an open passage through the conduit 48 and prevents the conduit 48 from collapsing when the internal volume 40 is filled with filling material or media. In various embodiments, each support structure 28 is formed of any number of resilient metals (such as stainless steel, cobalt-chromium (CoCr), nickel-titanium alloy, or resilient polymer).

[0067] In various embodiments, the master graft body 22 and the filling structure 26 are positioned such that the windows 24a, 24b and the conduit 48 are aligned with the orifices of the renal arteries 12a, 12b to provide a non-torsional path for the support structure 28. In some embodiments, the master graft body 22 and the filling structure 26 are individually constructed based on the specific configuration of the patient's blood vessel in which the endovascular prosthesis 20 is placed. In some embodiments, the windows 24a, 24b and / or the conduit 48 have oversized dimensions, such as a cross-sectional height or width greater than the diameter of the support structure 28, to provide greater flexibility in the placement of each support structure 28. The master graft body 22 and the filling structure 26 can be constructed in multiple configurations with different positioning of the windows 24a, 24b and the conduit 48. In various embodiments, the master graft body 22 and the filling structure 26 are selected to optimally match the specific configuration of the blood vessel in which the endovascular prosthesis 20 is to be placed.

[0068] refer to Figure 1 and Figure 3In some embodiments, the endovascular prosthesis 20 is disposed in the aorta 10 near the first renal artery 12a and the second renal artery 12b. In some embodiments, the endovascular prosthesis 20 is configured to interact with other prostheses. For example, in some embodiments, the endovascular prosthesis 20 is configured to be disposed together with a second endovascular prosthesis 58 having a bifurcated graft for placement in the iliac arteries 14a, 14b. In some embodiments, the second endovascular prosthesis 58 has any of the features of endovascular prostheses disclosed in U.S. Patent Application Serial No. 12 / 101,863, filed April 11, 2008 (titled “Bifrucated Graft Deployment System and Methods”), now U.S. Patent No. 8,236,040. The entire contents of that patent application are incorporated herein by reference as if fully set forth herein.

[0069] In various embodiments, the endovascular prosthesis 20 is configured to mate, interface with, or otherwise engage with other prostheses, such as the second endovascular prosthesis 58, to provide a continuous conduit thereby facilitating blood flow through the diseased portion of the aorta 10. In some embodiments, a portion of the second endovascular prosthesis 58 is received within the central lumen 30 of the master graft body 22. In some embodiments, a portion of the second endovascular prosthesis 58 receives the master graft body 22 such that this portion of the second endovascular prosthesis 58 is located between the master graft body 22 and the filling structure 26. In various embodiments, the endovascular prosthesis 20 utilizes the anatomical bifurcation of the second endovascular prosthesis 58 through interconnection with it, for fixation in addition to aneurysm sealing.

[0070] Figure 4 , Figure 5 , Figure 6 , Figure 7 , Figure 8 , Figure 9 , Figure 10 and Figure 11 This is a schematic representation of a method for positioning and implanting an intraluminal prosthesis 20 in a desired aortic location, according to an embodiment. A placement catheter 60 is positioned in the aorta 10, as... Figure 4 As shown. The placement catheter 60 includes a hollow outer sheath 62 in which the endoluminal prosthesis 20 is compressed and loaded for delivery to the desired location. According to an exemplary embodiment, the placement catheter 60 is advanced over a guidewire through a puncture site in the patient's groin to enter the iliac artery via a seldinger technique. In various embodiments, the placement catheter 60 is positioned to place the endoluminal prosthesis 20 in a manner that maintains the patency of the branch vessels. Reference Figure 1 , Figure 2 and Figure 4 In some embodiments, the position and angular orientation (e.g., rotation) of the intracavitary prosthesis 20 are controlled such that each of the windows 24a, 24b is aligned with a corresponding one of the renal arteries 14a, 14b (e.g., using radiopaque marker 63 to aid in positioning), and the window 34 at the end of the main graft body 22 is aligned with the SMA 16.

[0071] Once properly positioned within the aorta 10, the outer sheath 62 of the placement catheter 60 retracts to allow placement of the intraluminal prosthesis 20, such as... Figure 5 As shown. In some embodiments, the intracavitary prosthesis 20 is secured in place during the procedure, for example, using a lockwire. In some embodiments, at least one pre-inserted guidewire 64 is provided. Reference Figure 1 , Figure 2 and Figure 5 In various embodiments, each pre-inserted guidewire 64 extends from the central cavity 30 of the master graft body 22, passes through corresponding windows 24a and 24b, passes through corresponding conduits 48 in the filling structure 26, and exits toward the anterior cone 65 of the placement catheter 60. In various embodiments, each pre-inserted guidewire 64 extends below a support structure 28 stored in a folded state within a sheath 62. In some embodiments, one or more radiopaque markers 63 are provided at one or more of the windows 24a, 24b to aid in the positioning of each pre-inserted guidewire 64. In some embodiments, additional radiopaque markers are provided on the outer wall 42 and / or inner wall 44 of the filling structure 26 near the conduits 48 to further aid in the positioning of the element within the patient.

[0072] In some embodiments, two pre-inserted guidewires 64 are positioned approximately in the renal arteries 12a and 12b, such as... Figure 6 As shown. However, in other embodiments, if the endovascular prosthesis 20 is configured to have a support structure for an additional vessel, three or more pre-cannulated guidewires are provided to accommodate the additional vessel, such as the celiac artery 18 or SMA 16.

[0073] refer to Figure 1 , Figure 6 and Figure 7In various embodiments, a corresponding pre-bent angiography catheter 66 follows each pre-inserted guidewire 64 from the central lumen 30 of the master graft body 22, through corresponding windows 24a and 24b, and through corresponding conduits 48 in the filling structure 26. In various embodiments, each pre-inserted guidewire 64 is withdrawn, and the corresponding guidewire 68 advances through the orifice of the target vessel to cannulate the catheter into the target vessel. In various embodiments, each angiography catheter 66 advances into the corresponding target vessel. Reference Figure 7 and Figure 8 In some embodiments, each guidewire 68 is retracted and a corresponding stiffer guidewire 69 is advanced into each target blood vessel.

[0074] In various embodiments, the angiography catheter 66 is subsequently withdrawn, and each folded support structure 28 is advanced over a corresponding stiffer guidewire 69 into the corresponding target vessel. Each support structure 28 then expands within the corresponding target vessel. Each expanded support structure 28 abuts against the corresponding target vessel to secure the endovascular prosthesis 20 in the desired position. Figure 8 , Figure 9 and Figure 10 As shown, in some embodiments, each support structure 28 includes a balloon-expandable stent. In some embodiments, each support structure 28 includes a self-expanding stent that expands as the proximal end of the corresponding outer sheath retracts. In some embodiments, each support structure 28 can be any suitable structure for maintaining the patency of the target vessel and providing fixation for the endovascular prosthesis 20.

[0075] In various embodiments, as each support structure 28 expands (e.g., through the expansion of the corresponding balloon catheter), the filling structure 26 is filled, such as Figure 9 As shown. (Refer to...) Figure 2 and Figure 9In various embodiments, the lumen 46 is supported, for example, by a balloon catheter 70 or other expandable structure that is inflated or expanded to open the lumen 46. In some embodiments, the balloon catheter 70 is formed of a generally compliant material and has a maximum diameter or width equal to or slightly larger than the desired diameter or width of the lumen 46 through the deployed filling structure 26. In various embodiments, the balloon catheter 70 is configured to provide an open channel 72 through which blood can continue to flow throughout the filling process. By preventing complete closure of the aorta 10, the forces exerted on the endoluminal prosthesis 20 by blood flow during placement can be minimized. In some embodiments, the filling structure 26 is first inflated with a temporary filling medium. For example, in an exemplary embodiment, the filling structure 26 is first filled with a saline solution. The temporary filling medium inflates the filling structure 26 and allows the positioning of the filling structure 26 and its seal with the aortic wall to be verified (e.g., by angiography).

[0076] refer to Figure 2 and Figure 10 In various embodiments, after the filling structure 26 is properly positioned, the filling structure 26 is aspirated and a hardenable filling medium is introduced into the internal volume 40. In various embodiments, the hardenable filling medium is introduced into the internal volume 40 of the filling structure 26 through an opening in the wall of the filling structure 26, such as through a valve 56, using a filling tube 74. In some embodiments, the internal volume 40 is a continuous volume, and the filling medium is introduced through a single valve 56. In some embodiments, as described in more detail below, the internal volume 40 is divided into multiple chambers or compartments, and the filling structure 26 includes multiple filling valves to allow each of the multiple chambers or compartments to be individually filled with the filling medium.

[0077] The filling of the internal volume 40 causes the outer wall 42 of the filling structure 26 to expand outward, such that the outer wall conforms to the inner surface of the aorta 10 and the aneurysm 11, as... Figure 11 As shown. Reference Figure 2 and Figure 11 In various embodiments, each support structure 28 prevents the corresponding conduit 48 from constricting and maintains an open passage from the lumen 46 to the corresponding renal artery 12a, 12b. In various embodiments, the outer wall 42 of the filling structure 26 forms a seal with the aortic wall surrounding the orifice of the renal artery 12a, 12b.

[0078] In various embodiments, after the filling material has been introduced into the filling structure 26, the fluid filling material is cured or otherwise hardened to provide a permanent implant with a generally fixed structure that will remain in place with a specific aneurysm geometry. In some embodiments, after the filling material has cured, the seal between the filling structure 26 and the wall of the aorta 10 is verified (e.g., by angiography). In some embodiments, a balloon catheter 70 supporting the lumen 46 of the filling structure 26 (see...) Figure 9 The balloon catheters of each support structure 28 are aspirated and removed, the locking line is released, and catheter 60 is deployed (see reference). Figure 9 The method for curing or hardening filler materials varies depending on the nature of the filler material. For example, some exemplary polymers are cured by applying energy (such as heat or ultraviolet light). Other exemplary polymers are cured upon exposure to body temperature, oxygen, or other conditions that cause the fluid filler material to polymerize. There are also several other exemplary polymers that are mixed immediately before use and simply cured after a fixed time (such as several minutes).

[0079] Furthermore, any endovascular prosthesis described herein may be used independently or in combination with one or more additional grafts, including the grafts disclosed herein or any other suitable graft such as other tubular or bifurcation grafts. For example, but not limited to, endovascular prosthesis 20 may be used in combination with additional prostheses configured to be identical or similar to endovascular prosthesis 20 for adaptation to additional branch vessels (such as celiac artery 18 or SMA 16), and / or with any other suitable prosthesis (such as, but not limited to, bifurcation prostheses, such as...). Figure 11 The second endovascular prosthesis 58 shown is used in conjunction with this. This additional prosthesis can be placed using the same or similar procedure as the endovascular prosthesis 20, and can be placed before or during the placement of the endovascular prosthesis 20. For example, in some embodiments, the endovascular prosthesis 20 is placed in a secondary surgery to treat an aneurysm previously treated with a bifurcation prosthesis.

[0080] Some arrangements involve methods for placing an endovascular prosthesis (such as, but not limited to, the endovascular prosthesis 20 described above), including: inserting a delivery catheter into an artery; positioning the endovascular prosthesis in a desired location; placing a pre-cannulated guidewire near a target branch artery; following the pre-cannulated guidewire from the central lumen of the master graft, through a window or other opening in the master graft, and through a filling structure; withdrawing the pre-cannulated guidewire and advancing it through the orifice of the target vessel to insert the catheter into the target vessel; advancing the angiography catheter into the target vessel; withdrawing the guidewire and advancing a stiffer guidewire into the target vessel; advancing a corrugated support structure above the guidewire into the target vessel; expanding the support structure in the target vessel; inflating a balloon to support the central lumen of the filling structure; pre-filling the filling structure with a temporary filling medium; verifying the seal and position of the filling structure by angiography; aspirating the temporary filling medium from the filling structure; filling the filling structure with a hardenable filling medium; and verifying the seal of the filling structure by angiography. In some embodiments, the method of placing an intraluminal prosthesis further includes placing a second intraluminal prosthesis such that the second intraluminal prosthesis interacts with the first intraluminal prosthesis, for example, to form a continuous lumen through which blood can flow. The steps of the foregoing process can be performed in the described order, or in any suitable order. In some arrangements, the target branch vessel is the renal artery. For example, in some embodiments, the step of filling the filling structure with a hardenable filling medium is performed after the second intraluminal prosthesis is placed into the artery.

[0081] Figure 12 This is a perspective view of another embodiment of the intracavitary prosthesis 20. Figure 13A and Figure 13B It is placed in the patient's anatomical structure Figure 12 A cross-sectional view of the intracavitary prosthesis 20. (Refer to...) Figure 12 and Figure 13AIn various embodiments, the infill structure 26 includes a variable geometry portion 80 to accommodate various positions of each support structure 28. In some embodiments, the variable geometry portion 80 defines windows 82 on both sides of the variable geometry portion 80, each window having an arc length 83 greater than the width of the corresponding support structure 28. In some embodiments, a variable length structure or baffle 84 is disposed at the side edges on both sides of each window 82. In various embodiments, the baffle 84 is shaped to fill each window 82 and is oversized relative to each window 82. That is, in various embodiments, the baffle 84 is larger than the corresponding dimension of each window 82 (e.g., perimeter, arc length, height, etc.) in at least one dimension to form a seal with the surface of the infill structure 26, the aforementioned surface of the infill structure 26 defining the top and bottom of each window 82. In some embodiments, each baffle 84 has a compression length 85 that can expand to be equal to or greater than the compression length plus the arc length 83 of the window 82, such that a single baffle 84 can seal the entire window 82.

[0082] In various embodiments, during placement of the endovascular prosthesis 20, the variable geometry portion 80 is positioned such that each window 82 is aligned with a corresponding target vessel. In some embodiments, each support structure 28 advances through the corresponding window 82 and enters the corresponding target vessel, and is then expanded using a balloon catheter or other suitable dilation mechanism. In various embodiments, each baffle 84 is inflated by filling it with a filling medium. In some such embodiments, when each baffle 84 is filled, it expands (e.g., unfolds) to fill each window 82 onto the corresponding side of each support structure 28. In various embodiments, the oversized nature of each baffle 84 allows each window 82 to be filled on both sides of the corresponding support structure 28 within the window 82, regardless of the positioning of the corresponding support structure 28 within the window 82. In some embodiments, each baffle 84 is in fluid communication with the internal volume of the remainder of the filling structure 26 and is filled from a main filling valve for the filling structure 26. In some embodiments, each baffle 84 is fluidly isolated from the remainder of the filling structure 26 and is filled through one or more dedicated filling valves.

[0083] In various embodiments, the filling structure 26, including the variable geometry portion 80, is positioned at a desired location within the aorta 10, with the variable geometry portion 80 aligned with a target branch vessel in which the support structure 28 will be arranged. In some embodiments, a pre-cannulated guidewire extends from the central lumen of the graft body, through a corresponding window in the graft body, through a corresponding window 82 of the variable geometry portion 80, and exits toward the anterior cone of the catheter placement area. In some embodiments, additional radiopaque markers are provided on the outer wall 42 or inner wall 44 of the filling structure 26 near each window 82 to aid in the positioning of each window 82. In various embodiments, this arrangement continues as described above, with each folded support structure 28 advancing over a corresponding stiffer guidewire through the corresponding window 82 and into the corresponding target vessel. Each support structure 28 can then be expanded within the corresponding target vessel.

[0084] refer to Figure 12 and Figure 13B In various embodiments, the filling structure 26 is appropriately positioned and pre-filled with saline, aspirated, and then filled with a hardenable filling medium. In some embodiments, each baffle 84 is in fluid communication with the internal volume of the filling structure 26 such that each baffle 84 expands to fill each window 82 as the filling structure 26 expands. In some embodiments, if each baffle 84 is fluidly isolated from the internal volume of the rest of the filling structure 26, the baffle 84 is filled with the hardenable filling medium via a separate filling valve. In various embodiments, each support structure 28 prevents each baffle 84 from completely blocking the corresponding window 82 and maintains an open passage from the lumen 46 to the corresponding target blood vessel.

[0085] Figure 14 This is a partial cross-sectional view of another embodiment of an intracavitary prosthesis 20 arranged in the patient's anatomical structure, including an embodiment of a filling structure 26 having a plurality of tubes 48. Figure 15 This is a perspective view schematically representing an embodiment of a filling structure 26 having multiple pipes 48. (See reference) Figure 14 and Figure 15 In various embodiments, the filling structure 26 includes a plurality (e.g., more than two) of tubes 48 placed along the length of the filling structure 26 and extending in various directions. In various embodiments, the plurality of tubes 48 allows the filling structure 26 to be used with a variety of patients without having to select or manufacture the filling structure 26 to match the geometry of a particular patient being treated.

[0086] In various embodiments, when arranged, the endovascular prosthesis 20 is equipped with multiple pre-cannulated guidewires corresponding to the number of vessels to be cannulated. The pre-cannulated guidewires are positioned approximately at the location of the target vessels (e.g., renal arteries 12a, 12b, SMA 16, celiac artery 18, etc.). In various embodiments, each support structure 28 is arranged via a corresponding conduit 48 aligned with the corresponding target vessel.

[0087] In various embodiments, the filling structure 26 is appropriately positioned, pre-filled with saline, aspirated, and then filled with a hardenable filling medium. In various embodiments, the filling of the internal volume 40 of the filling structure 26 expands the outer wall 42 of the filling structure 26 outward, such that the outer wall conforms to the inner surface of the aorta 10 and the aneurysm space. In various embodiments, each support structure 28 prevents the corresponding conduit 48 aligned with the target vessel from collapsing and maintains an open passage from the lumen 46 to the target vessel. Simultaneously, in various embodiments, the filling material or medium causes any conduit 48 in which no support structure 28 is located to collapsing, forming a permanent implant.

[0088] Figure 16 This is a partial cross-sectional view of another embodiment of an intracavitary prosthesis 20 arranged in the anatomical structure of a patient, the intracavitary prosthesis comprising a plurality of horizontal filling structures 90. Figure 17 This is a perspective view of the support structure 28 extending between the horizontally filled structures 90 in the unexpanded state. Figure 18 This is a perspective view of the support structure 28 extending between the horizontally filled structures 90 in an expanded state. (Refer to...) Figure 16 , Figure 17 and Figure 18 In various embodiments, the horizontal filler structure 90 is typically a donut-shaped body comprising an internal volume 92 defined by an outer wall 94 and an inner wall 95. In various embodiments, the stack of horizontal filler structures 90 defines an inner cavity 96. In some embodiments, the inner cavity 96 is configured to receive the master graft body 22. In various embodiments, spaces or gaps 98 are provided between adjacent horizontal filler structures 90. In some such embodiments, the gaps 98 between the horizontal filler structures 90 provide multiple channels through which the support structure 28 passes, and the stack of the horizontal filler structures 90 is positioned relative to the master graft body 22 such that the gaps 98 are aligned with corresponding windows of the master graft body 22. Although Figure 16 Only two support structures 28 are shown in the renal arteries 12a and 12b, respectively, but multiple gaps 98 between the horizontal filling structures 90 can accommodate multiple support structures. For example, in other embodiments, the gaps 98 between the horizontal filling structures 90 receive support structures 28 disposed in other branch vessels (e.g., SMA 16 and celiac artery 18).

[0089] Reference Figure 17 In some embodiments, the horizontal fill structures 90 are joined together by attachment portions 99. For example... Figure 17 As shown, in some embodiments, the horizontal fill structures 90 are directly connected to each other via at least one attachment portion 99. In various embodiments, the horizontal fill structures 90 are connected together via a web or other separate body that is coupled between the horizontal fill structures 90.

[0090] refer to Figure 16 , Figure 17 and Figure 18 In various embodiments, the horizontal filling structure 90 includes at least one valve 100 to allow the introduction of filling material or media into the internal volume 92. In some embodiments, the internal volumes 92 of the horizontal filling structure 90 are in fluid communication with each other and are filled from a single filling valve 100. In some embodiments, the internal volumes 92 of the horizontal filling structure 90 are fluidly isolated from each other, and each internal volume is filled via a dedicated filling valve.

[0091] In various embodiments, during placement of the endovascular prosthesis 20, the horizontal filler structure 90 is positioned such that one of the gaps 98 is aligned with the target vessel. In some such embodiments, a corresponding support structure 28 for the target vessel advances through the gap 98 and enters the target vessel, and then expands the support structure using a balloon catheter or other suitable dilation mechanism. The horizontal filler structure 90 is expanded by filling it with a filling medium. In various embodiments, as it expands with the filling material or medium delivered to the internal space 92, the outer wall 94 expands outward, upward, and downward, and the inner wall 95 expands inward. In various embodiments, the inward expansion causes the lumen 96 to contract, forming a seal with the master graft body 22. In various embodiments, the outward expansion expands the outer diameter of the horizontal filler structure 90, allowing the horizontal filler structure 90 to match the geometry of the specific patient to be treated. The upward and downward expansion closes the gaps 98 between adjacent horizontal filler structures 90 and forms a seal around the support structure 28 extending through the gaps 98.

[0092] Figure 19 This is a partial sectional view of the patient's vascular system, showing a pair of endovascular prostheses 120a, 120b arranged in a desired location within the patient's aorta 10 according to one embodiment. For reference, the patient's first renal artery 12a and second renal artery 12b, the patient's first iliac artery 14a and second iliac artery 14b, the patient's superior mesenteric artery (SMA) 16, and the patient's celiac artery 18 are also shown. A subrenal abdominal aortic aneurysm 11 is also shown between the renal arteries 12a and 12b and the iliac arteries 14a and 14b, and a mural thrombus region may be present on a portion of the inner surface of this subrenal abdominal aortic aneurysm.

[0093] Figure 20 This is a front view of an intracavitary prosthesis 120 according to one embodiment, which can be used for... Figure 19 The design of each of the pair of intracavitary prostheses 120a and 120b shown is illustrated. (Reference) Figure 19 and Figure 20 A first endovascular prosthesis 120a is disposed on one side of the aorta 10 to facilitate blood flow to the first renal artery 12a and the first iliac artery 14a, and a second endovascular prosthesis 120b is disposed on the other side of the aorta 10 to facilitate blood flow to the second renal artery 12b and the second iliac artery 14b. In various embodiments, the endovascular prostheses 120a and 120b generally have an asymmetrical construction, and they are configured to be positioned adjacent to each other within the aneurysm 11 and to fill the space in combination. Because the first endovascular prosthesis 120a and the second endovascular prosthesis 120b are structurally similar, the same reference numerals will be used to describe the corresponding components of the first endovascular prosthesis 120a and the second endovascular prosthesis 120b.

[0094] In various embodiments, the intracavitary prosthesis 120 includes: a master graft body 122 including a window 124 (e.g., a scalloped opening, incision, or opening); a support structure 125; a double-walled filling structure 126 in the region of the aneurysm 11; and a support structure 128 extending through the window 124 and through the filling structure 126.

[0095] The master graft body 122 defines a central lumen 130. The master graft body 122 provides a synthetic vascular wall that guides blood flow through the diseased portion of the blood vessel. In various embodiments, the intraluminal prosthesis 120 is positioned such that a window portion 124 is aligned with a branch of the aorta 10. In some embodiments, the window portion 124 is aligned with one of the renal arteries 12a, 12b, such that a fluid pathway is formed from the central lumen 130 to the corresponding renal artery 12a, 12b. The master graft body 122 may be formed of any suitable material, such as, but not limited to, ePTFE, PTFE, and parylene.

[0096] In some embodiments, a support structure 125 (e.g., a covered stent, a bare wire stent, etc.) or any other suitable stent or anchoring device is disposed within the central cavity 130 of the master graft body 122 to secure the master graft body 122 in a desired position. In various embodiments, the support structure 125 presses the master graft body 122 against a fillable structure 126 disposed between the master graft body 122 and the vessel wall, and secures the master graft body 122 and the window portion 124 in the desired position. In some embodiments, the support structure 125 is formed of any number of resilient metals, such as stainless steel, cobalt-chromium (CoCr), nickel-titanium alloy, or resilient polymer. The support structure 125 may be coupled to an inner or outer surface of the master graft body 122. In various embodiments, the window portion 124 extends through the support structure 125 so that a support structure 128 can pass through the support structure 125.

[0097] In some embodiments, the support structure 125 extends along the entire length of the master graft body 122. In some embodiments, the support structure 125 extends only along a portion of the master graft body 122. For example, the support structure 125 may include an upper portion located near the top of the intracavitary prosthesis 120 adjacent to the renal arteries 12a, 12b, and a lower portion located separately from the upper portion and near the bottom of the intracavitary prosthesis 120 adjacent to the iliac arteries 14a, 14b.

[0098] In some embodiments, the master graft body 122 and the support structure 125 may have any features of the structure disclosed in U.S. Patent Application Serial No. 12 / 478,208, filed June 4, 2009, entitled “Docking Apparatus and Methods of Use”, the entire contents of which are incorporated herein by reference as if fully set forth herein.

[0099] In various embodiments, the filler structure 126 surrounds the master graft body 122 and, when expanded, occupies an annular space between the master graft body 122 and the wall of the aorta 10. In some embodiments, the filler structure 126 includes an internal volume 140 defined between an outer wall 142 and an inner wall 144. In various embodiments, the geometry of the filler structure 126 is selected or manufactured to match the geometry of a particular patient to be treated. In various embodiments, upon expansion by filler material or media delivered to the internal space 140, the outer wall 142 of the filler structure 126 expands radially outward and the inner wall 144 expands inward. In some embodiments, the inner wall 144 defines an inner lumen 146 configured to receive the master graft body 122.

[0100] In various embodiments, the filling structure 126 further includes at least one conduit 148 extending through the internal volume 140 of the filling structure 126 and aligned with the window portion 124 of the master graft body 122. The conduit 148 defines a channel 150 separate from the internal volume 140. The channel 150 opens at a first end 152 to the lumen 146 and at a second end 154 to the space surrounding the filling structure 126. In some embodiments, the filling structure 126 is coupled to the master graft body 122 and / or the support structure 125 via sutures to maintain the desired alignment of the conduit 148 with respect to the window portion 124. In some embodiments, the filling structure 126 is coupled to the master graft body 122 and / or the support structure 125 via adhesive or other suitable attachment mechanisms. In some embodiments, the filling structure 126 is integrally formed with the master graft body 122 such that the conduit 148 is aligned with the window portion 124.

[0101] In various embodiments, the filling structure 126 includes at least one valve 156 to allow the introduction of filling material or media into the internal volume 140 of the filling structure 126. In some embodiments, the valve 156 includes a simple disc valve. Other more complex ball valves and other one-way valve configurations may be used for the valve 156. In some embodiments, the valve 156 includes a two-way valve configuration to allow the filling and selective evacuation of the internal volume 140 of the filling structure 126. In some embodiments, the filling tube includes a needle or other filling structure to pass through the valve 156, thereby allowing the filling and removal of the filling medium.

[0102] In some embodiments, the master graft body 22 and / or support structure 125 extend beyond the lower end of the filling structure 126 and through the aneurysm region within the iliac arteries 14a, 14b, thereby allowing the structure to treat iliac artery aneurysms as well as aortic aneurysms.

[0103] Figure 21 Through Figure 19 A cross-sectional view of an embodiment of intracavitary prostheses 120a and 120b arranged in the patient's anatomical structure, taken by line 21-21. (Refer to...) Figure 19 , Figure 20 and Figure 21In some embodiments, the upper end of the support structure 125 is formed to have a D-shaped cross-section when expanded. In some such embodiments, the flat surface of each support structure 125 faces the flat surface of another support structure 125, while the remainder of the support structure 125 (e.g., curved surfaces) faces the inner wall of the aorta 10. In this way, a large portion of the cross-sectional area of ​​the aorta 10 is covered by the support structure 125, thereby enhancing blood flow through the endovascular prostheses 120a, 120b. In some embodiments, clips or other fastening devices, links, or tethers are provided to connect the upper end of the support structure 125. By attaching the end of the support structure 125, the ends of the endovascular prostheses 120a, 120b are stabilized, and the risk of support structure migration is reduced.

[0104] Figure 22 , Figure 23 , Figure 24 , Figure 25 , Figure 26 , Figure 27 , Figure 28 and Figure 29 This is a schematic diagram based on one embodiment, illustrating the placement of intracavitary prostheses 120a and 120b (see [reference]). Figure 19 The process of positioning and implanting the catheter 160 in the desired aortic location. In various embodiments, a pair of placement catheters 160 are positioned in the aorta 10, such as... Figure 22 As shown. Reference Figure 19 and Figure 22 The placement catheter 160 includes a hollow outer sheath 162, within which endovascular prostheses 120a and 120b are compressed and loaded for delivery to a desired location. According to an exemplary embodiment, the placement catheter 160 advances from each of the iliac arteries 14a and 14b into the aorta 10. According to an exemplary embodiment, each placement catheter 160 is advanced over a guidewire through a puncture site in the patient's groin to enter the corresponding iliac artery 14a or 14b via a femoral artery puncture. In various embodiments, the placement catheter 160 is positioned to place the endovascular prostheses 120a and 120b in a manner that maintains the patency of the branch vessels.

[0105] In some embodiments, the position and angular orientation (e.g., rotation) of the intraluminal prostheses 120a, 120b are controlled such that the window portion 124 is aligned with the target vessel (e.g., renal arteries 14a, 14b). The two intraluminal prostheses 120a, 120b can be repositioned independently of each other, allowing for greater flexibility in their positioning without obstructing branch arteries. In various embodiments, once properly positioned within the aorta 10, the outer sheath 162 of the placement catheter 160 retracts to expose the filling structure 126, as... Figure 23 As shown. Reference Figure 19 , Figure 20 and Figure 23 In various embodiments, intracavitary prostheses 120a, 120b are secured in place during surgery, for example, using locking sutures. In some embodiments, one or more pre-inserted guidewires 164 are provided. In various embodiments, each pre-inserted guidewire 164 extends from the central cavity 130 of the corresponding master graft body 122, through a corresponding window 124 in the master graft body 122, through a corresponding conduit 148 in the filling structure 126, and exits toward a corresponding anterior cone 165 of the corresponding placement conduit 160. In various embodiments, the pre-inserted guidewire 164 extends below a support structure 128 stored in a folded state within a sheath 162. In some embodiments, one or more radiopaque markers 163 are provided at the window 124 to aid in the positioning of the pre-inserted guidewire 164. In some embodiments, additional radiopaque markers are provided on the outer wall 142 and inner wall 144 of the filling structure 126 near the conduit 148.

[0106] In some embodiments, two pre-inserted guidewires 164 are positioned approximately in the renal arteries 12a and 12b, such as... Figure 24 As shown. In some embodiments, if the endovascular prosthesis is configured to have a support structure for an additional vessel, three or more pre-cannulated guidewires are provided to accommodate the additional vessel, such as celiac artery 18 and / or SMA 16.

[0107] refer to Figure 19 , Figure 20 , Figure 24 and Figure 25 In some embodiments, the pre-bent angiography catheter 166 extends from the central lumen 130 of the master graft body 122, through the window 124, and through the conduit 148 in the filling structure 126 (see...). Figure 25 The pre-cannulated guidewire 164 is followed. In various embodiments, the pre-cannulated guidewire 164 is withdrawn, and guidewire 168 is advanced through the orifice of the target vessel to insert the catheter into the target vessel. In some embodiments, the angiography catheter 166 is advanced into the target vessel. In some embodiments, guidewire 168 is withdrawn and a stiffer guidewire 169 (see reference) follows. Figure 26 It is propelled into the target blood vessel.

[0108] refer to Figure 25 and Figure 26 In various embodiments, the angiography catheter 166 is subsequently withdrawn, and the corrugated support structure 128 is advanced over the stiffer guidewire 129 into the target vessel. The support structure 128 then expands within the target vessel. The expanded support structure 128 abuts against the target vessel to secure the support structure 128 in the desired position. Figure 26 , Figure 27 and Figure 28As shown, in some embodiments, the support structure 128 is a balloon-expandable stent. In some embodiments, the support structure 128 is a self-expanding stent that expands as the proximal end of the outer sheath retracts. In some embodiments, the support structure 128 can be any suitable structure for maintaining the patency of the target vessel and providing fixation.

[0109] In various embodiments, when the support structure 128 expands (e.g., through the expansion of the balloon catheter), the filling structure 126 is filled, such as... Figure 28 As shown. Reference Figure 20 and Figure 28 In various embodiments, the lumen 146 is initially supported, for example, by a balloon catheter 170 or other expandable structure that expands or inflates to open the lumen 146. In some embodiments, the balloon catheter 170 is formed of a generally compliant material and has a maximum diameter or width equal to or slightly larger than the desired diameter or width of the lumen 146 through which the placed filling structure 126 is positioned. In some embodiments, the balloon catheter 170 is configured to provide an open channel 172 through which blood can continue to flow throughout the filling process. By preventing complete occlusion of the aorta 10, the forces applied to the endoluminal prosthesis during placement can be minimized. In some embodiments, the filling structure 126 is inflated by a temporary filling medium (e.g., a saline solution). In some such embodiments, the temporary filling medium inflates the filling structure 126 and allows the positioning of the filling structure 126 and its seal against the aortic wall to be verified (e.g., by angiography).

[0110] In some embodiments, one of the filling structure 126 and the associated balloon catheter 170 is first inflated, followed by the other of the filling structure 126 and balloon catheter 170. In various embodiments, each filling structure 126 is inflated to fill typically half the aneurysm volume. In some embodiments, after one filling structure 126 has been filled, another filling structure 126 may be filled. In some embodiments, both filling structures 126 are filled simultaneously.

[0111] In various embodiments, after the filling structure 126 is properly positioned, the filling structure 126 is aspirated and a hardenable filling medium is introduced into the internal volume 140. In some embodiments, a filling tube 174 is used to introduce the hardenable filling medium into the internal volume 140 through an opening in the wall of the filling structure 126 (such as through a filling valve 156).

[0112] refer to Figure 20 and Figure 29In various embodiments, the filling of the internal volume 140 of the filling structure 126 causes the outer wall 142 of the filling structure 126 to expand outward, such that the outer wall conforms to the inner surface of the aorta 10 and the aneurysm space. In various embodiments, the support structure 128 prevents the conduit 148 from constricting and maintains an open passage from the lumen 146 to the renal arteries 12a, 12b. The outer wall 142 of the filling structure 126 forms a seal with the aortic wall surrounding the orifices of the renal arteries 12a, 12b.

[0113] In various embodiments, after the filling material has been introduced into the filling structure 126, the fluid filling material is cured or otherwise hardened to provide a permanent implant with a generally fixed structure that will remain in place within a specific aneurysm geometry. In some embodiments, after the filling material has cured, the seal between the filling structure 126 and the wall of the aorta 10 is verified (e.g., by angiography). In some embodiments, a balloon catheter 170 (see [link to relevant documentation]) is located in the lumen 146 of the filling structure 126. Figure 28 The balloon catheter of the expansion support structure 128 is aspirated and removed, the locking line is released, and catheter 160 is deployed (see...). Figure 28 The method for curing or hardening the filler material depends on the nature of the filler material. For example, some exemplary polymers are cured by applying energy (such as heat or ultraviolet light). Other exemplary polymers are cured upon exposure to body temperature, oxygen, or other conditions that cause the fluid filler material to polymerize. There are also several other exemplary polymers that are mixed immediately before use and simply cured after a fixed time (such as several minutes).

[0114] Figure 30 This is a front view of another embodiment of the intracavitary prosthesis 120a, 120b. In various embodiments, each of the intracavitary prostheses 120a, 120b includes: a master graft body 122 including a window 124 (e.g., a scalloped opening, incision, or opening); a support structure 125; a double-walled filling structure 126 in the region of the aneurysm 11; and support structures 128, each extending through the respective window 124 and through the respective filling structure 126.

[0115] In various embodiments, each of the endovascular prostheses 120a, 120b further includes a corresponding second window 134. In various embodiments, the second window 134 is positioned such that when the corresponding window 124 is aligned with a first branch vessel (such as one of the renal arteries 12a, 12b), the second window 134 is aligned with another branch vessel (such as the SMA 16, celiac artery 18, etc.). In various embodiments, an additional conduit aligned with the second window 134 is provided in the filling structure 126. In some embodiments, according to the process described above with respect to the window, an additional support structure is arranged in the branch vessel aligned with the second window 134.

[0116] In some embodiments, the intraluminal prostheses 120a and 120b are arranged without the use of support structures such as support structure 125 or support structure 128. Instead, in some embodiments, the intraluminal prostheses 120a and 120b are positioned and secured in place solely using the interface between the vessel wall and the filling structure 126. According to exemplary embodiments, the hardenable filling medium that causes the internal volume of each filling structure 126 to expand is an elastic material. In some embodiments, forces applied to the filling structure 126 (e.g., fluid pressure applied to the filling structure 126 via blood flow) cause the filling structure 126 to temporarily deform, thereby causing the forces to be absorbed by the elastic filling medium and transferred to the vessel wall.

[0117] This document discloses systems and methods for placing endovascular prostheses (such as, but not limited to, the aforementioned prostheses), including: inserting a delivery catheter (such as a placement catheter) into an artery; placing the endovascular prosthesis in a desired location; placing a pre-cannulated guidewire near a target branch artery; following each pre-cannulated guidewire with a pre-bent angiography catheter from the central lumen of the master graft, through a window or other opening in the master graft, and a filling structure; withdrawing the pre-cannulated guidewire and advancing it through the orifice of the target vessel to insert the catheter into the target vessel; advancing the angiography catheter into the target vessel; withdrawing the guidewire and advancing a stiffer guidewire into the target vessel; advancing a corrugated support structure above the guidewire into the target vessel; expanding the support structure in the target vessel; inflating a balloon to support the central lumen of the filling structure; pre-filling the filling structure with a temporary filling medium; verifying the seal and position of the filling structure by angiography; aspirating the temporary filling medium from the filling structure; filling the filling structure with a hardenable filling medium; and verifying the seal of the filling structure by angiography. According to various embodiments, the steps of the foregoing process can be performed in the described order, or in any suitable order, and one or more steps may be omitted in various embodiments. In some arrangements, the target branch vessel is the renal artery. For example, in some embodiments, the step of filling the filling structure with a hardenable filling medium with an endovascular prosthesis is performed before the step of filling the filling structure with a hardenable filling medium with a second endovascular prosthesis.

[0118] According to alternative embodiments, the order or sequence of any process or method steps can be changed or rearranged. Other substitutions, modifications, changes, and omissions can also be made in the design, operating conditions, and arrangements of various exemplary embodiments without departing from the scope of the invention.

[0119] The construction and arrangement of the elements of the intracavitary prosthesis shown in the exemplary embodiments are merely illustrative. Although embodiments of this disclosure have been described in detail, it will be readily understood by those skilled in the art that many modifications can be made (e.g., variations in the size, dimensions, structure, shape, and proportions of various elements, values ​​of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without substantially departing from the novel teachings and advantages of the subject matter. For example, an element shown as integrally formed may be composed of multiple parts or elements. Similar components have been described in different figures throughout this disclosure using the same reference numerals. This should not be construed as implying that these components are identical in all embodiments; various modifications can be made in the various different embodiments. It should be noted that the elements and / or components of the housing may be constructed from any of a variety of materials that provide sufficient strength or durability, and may be any of a variety of colors, textures, and combinations thereof.

Claims

1. A graft system, comprising: A graft body having a cut or opening in its side surface, through which a support structure can be inserted; as well as A filling structure, surrounding at least a portion of the graft body, defines an internal volume that can be filled with a filling medium, and has a conduit passing through the internal volume, through which the support structure can be inserted. The filling structure includes a baffle configured to be filled with the filling medium and a window, the width of the window being greater than the width of the support structure, and partially opening the graft body before the baffle is filled with the filling medium; as well as When the support structure is disposed within the window, the baffle, which expands by being filled with the filling medium, reaches the outer surface of the support structure to form the conduit; and When the support structure is not located within the window, the baffle, which expands by filling the baffle with the filling medium, completely seals the window.

2. The graft system according to claim 1, in, The conduit in the filling structure can be aligned with the incision or opening in the graft body, so that the support structure can be inserted through both the conduit in the filling structure and the incision or opening in the graft body.

3. The graft system according to claim 1, in, The incision or opening in the graft body and the conduit in the filling structure can be aligned with the renal artery.

4. The graft system according to claim 1, further comprising: A support is attached to the graft body at a location entirely above the incision or opening in the graft body.

5. The graft system according to claim 1, in, The graft body is configured to have an augmentation portion having loose graft material to allow the incision or opening to be moved to align the incision or opening with an artery.

6. The graft system according to claim 1, in, The filling structure is configured to have a plurality of pipes positioned along the length of the filling structure.

7. The graft system according to claim 6, in, The filling structure is configured such that each of the plurality of pipes can collapse when the filling structure is filled with the filling medium.

8. A graft system comprising: The graft itself has an incision or opening on its lateral surface; A support structure that can be inserted through the cut or opening; A filling structure, surrounding at least a portion of the graft body, defines an internal volume that can be filled with a filling medium, and has a conduit through the internal volume, wherein the support structure can be inserted through the conduit; as well as window, The filling structure includes a baffle configured to be filled with the filling medium, and When filling, the baffle expands to fill the window to the corresponding side of the support structure.

9. The graft system according to claim 8, wherein, The baffle is too large relative to the window.

10. The graft system according to claim 8, wherein, The baffle is in fluid communication with the internal volume of the filling structure.

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