US20110054586A1 - Apparatus and method of placement of a graft or graft system - Google Patents

Abstract

Some embodiments relate to endoluminal prostheses having a first stent portion and a second stent portion, a main graft body comprising first, second, and third portions, the second portion having a cross-sectional size that is significantly larger than a cross-sectional size of the first or third portions, and also significantly larger than a cross-sectional size of the target vessel. In some embodiments, the first portion of the main graft body can be attached to the first stent portion and the third portion of the main graft body can be attached to the second stent portion. The prostheses can be configured such that the second portion of the main graft body is not directly attached to the first stent portion, the second stent portion, or any other internal support structure. In some embodiments, one or more openings can be formed in the second portion of the main graft body.

Description

PRIORITY INFORMATION AND INCORPORATION BY REFERENCE
• This application claims priority benefit under 35 U.S.C. §119(e) of Provisional Application 61/173,485 filed Apr. 28, 2009, Provisional Application 61/228,048 filed Jul. 23, 2009, and Provisional Application 61/231,898 filed Aug. 6, 2009, which applications are hereby incorporated by reference as if fully set forth herein. Additionally, U.S. patent application Ser. No. 12/496,446, filed on Jul. 1, 2009 (entitled “CATHETER SYSTEM AND METHODS OF USING SAME”), U.S. patent application Ser. No. 12/390,346, filed on Feb. 20, 2009 (entitled “DESIGN AND METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM”), U.S. patent application Ser. No. 12/101,863, filed on Apr. 11, 2008 (entitled “BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS”), U.S. Pat. No. 6,077,296, filed on Mar. 4, 1998 (entitled “ENDOLUMINAL VASCULAR PROSTHESIS”), U.S. Pat. No. 6,953,475, filed on Sep. 30, 2003 (entitled “BIFURCATION GRAFT DEPLOYMENT CATHETER”), and U.S. Pat. No. 7,520,895, filed on Apr. 8, 2002 (entitled “SELF EXPANDING BIFURCATED ENDOVASCULAR PROSTHESIS”) are also hereby incorporated by reference in their entireties as if fully set forth herein.
BACKGROUND OF THE DISCLOSURE
• 1. Technical Field
• The present invention relates to endoluminal vascular prostheses and methods of deploying such prostheses, and, in one application, to endoluminal vascular prostheses for use in the treatment of vessels with branches.
• 2. Description of the Related Art
• An abdominal aortic aneurysm is a sac caused by an abnormal dilation of the wall of the aorta, a major artery of the body, as it passes through the abdomen. The abdomen is that portion of the body that lies between the thorax and the pelvis. It contains a cavity, known as the abdominal cavity, separated by the diaphragm from the thoracic cavity and lined with a serous membrane, the peritoneum. The aorta is the main trunk, or artery, from which the systemic arterial system proceeds. It arises from the left ventricle of the heart, passes upward, bends over and passes down through the thorax and through the abdomen to about the level of the fourth lumbar vertebra, where it divides into the two common iliac arteries.
• The aneurysm usually arises in the infrarenal portion of the diseased aorta, for example, below the kidneys. When left untreated, the aneurysm may eventually cause rupture of the sac with ensuing fatal hemorrhaging in a very short time. High mortality associated with the rupture led initially to transabdominal surgical repair of abdominal aortic aneurysms. Surgery involving the abdominal wall, however, is a major undertaking with associated high risks. There is considerable mortality and morbidity associated with this magnitude of surgical intervention, which in essence involves replacing the diseased and aneurysmal segment of blood vessel with a prosthetic device which typically is a synthetic tube, or graft, usually fabricated of polyester, urethane, Dacron™, Teflon™, or other suitable material.
• To perform the surgical procedure requires exposure of the aorta through an abdominal incision which can extend from the rib cage to the pubis. The aorta must typically be closed both above and below the aneurysm, so that the aneurysm can then be opened and the thrombus, or blood clot, and arteriosclerotic debris removed. Small arterial branches from the back wall of the aorta are tied off The Dacron™ tube, or graft, of approximately the same size of the normal aorta is sutured in place, thereby replacing the aneurysm. Blood flow is then reestablished through the graft. It is necessary to move the intestines in order to get to the back wall of the abdomen prior to clamping off the aorta.
• If the surgery is performed prior to rupturing of the abdominal aortic aneurysm, the survival rate of treated patients is markedly higher than if the surgery is performed after the aneurysm ruptures, although the mortality rate is still quite high. If the surgery is performed prior to the aneurysm rupturing, the mortality rate is typically slightly less than 10%. Conventional surgery performed after the rupture of the aneurysm is significantly higher, one study reporting a mortality rate of 66.5%. Although abdominal aortic aneurysms can be detected from routine examinations, the patient does not experience any pain from the condition. Thus, if the patient is not receiving routine examinations, it is possible that the aneurysm will progress to the rupture stage, wherein the mortality rates are significantly higher.
• Disadvantages associated with the conventional, prior art surgery, in addition to the high mortality rate include the extended recovery period associated with such surgery; difficulties in suturing the graft, or tube, to the aorta; the loss of the existing aorta wall and thrombosis to support and reinforce the graft; the unsuitability of the surgery for many patients having abdominal aortic aneurysms; and the problems associated with performing the surgery on an emergency basis after the aneurysm has ruptured. A patient can expect to spend from one to two weeks in the hospital after the surgery, a major portion of which is spent in the intensive care unit, and a convalescence period at home from two to three months, particularly if the patient has other illnesses such as heart, lung, liver, and/or kidney disease, in which case the hospital stay is also lengthened. Since the graft must typically be secured, or sutured, to the remaining portion of the aorta, it is many times difficult to perform the suturing step because the thrombosis present on the remaining portion of the aorta, and that remaining portion of the aorta wall may be friable, or easily crumbled.
• Since many patients having abdominal aortic aneurysms have other chronic illnesses, such as heart, lung, liver, and/or kidney disease, coupled with the fact that many of these patients are older, the average age being approximately 67 years old, these patients are not ideal candidates for such major surgery.
• More recently, a significantly less invasive clinical approach to aneurysm repair, known as endovascular grafting, has been developed. Parodi, et al. provide one of the first clinical descriptions of this therapy. Parodi, J. C., et al., “Transfemoral Intraluminal Graft Implantation for Abdominal Aortic Aneurysms,” 5 Annals of Vascular Surgery 491 (1991). Endovascular grafting involves the transluminal placement of a prosthetic arterial graft in the endoluminal position (within the lumen of the artery). By this method, the graft is attached to the internal surface of an arterial wall by means of attachment devices (expandable stents), typically one above the aneurysm and a second stent below the aneurysm.
• Stents can permit fixation of a graft to the internal surface of an arterial wall without sewing or an open surgical procedure. Expansion of radially expandable stents is conventionally accomplished by dilating a balloon at the distal end of a balloon catheter. In U.S. Pat. No. 4,776,337, for example, Palmaz describes a balloon-expandable stent for endovascular treatments. Also known are self-expanding stents, such as described in U.S. Pat. No. 4,655,771 to Wallsten.
• In certain conditions, the diseased region of the blood vessels can extend across branch vessels. The blood flow into these branch vessels is critical for the perfusion of the peripheral regions of the body and vital organs. Many arteries branch off the aorta. For example, the carotid arteries supply blood into the brain, the renal arteries supply blood into the kidneys, the superior mesenteric artery (“SMA”) supplies the pancreas, the hypogastric arteries supply blood to the reproductive organs, and the subclavian arteries supply blood to the arms. When the aorta is diseased, the branch vessels may also be affected. Thoracic aortic aneurysms may involve the subclavian and carotid arteries, abdominal aneurysms may involve the SMA, renal and hypogastric arteries. Aortic dissections may involve all branch vessels mentioned above. When this occurs, it may be detrimental to implant a conventional tubular graft in this location of the aorta or the blood vessel, since such a graft may obstruct the flow of blood from the aorta into the branches.
• Grafts and graft systems are typically used to treat aneurysms in the aorta or in other blood vessels. These grafts can be positioned within the aorta or other blood vessels at the location of an aneurysm and, generally speaking, can provide a synthetic vessel wall that channels the flow of blood through the diseased portion of the blood vessel. As such, the grafts are typically fluid impermeable so that no blood can flow through the walls of the graft. Rather, the blood is channeled through the central passageway defined by the graft.
• Thus, there is a need to place endoluminal prostheses in the aorta without obstructing critical branch vessels. The embodiments of the endoluminal prostheses disclosed herein provide a solution to the problems described above.
SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS
• Some embodiments of the endoluminal prostheses disclosed (directly and/or by incorporation by reference) herein pertain to designs and methods of placement of a branch graft or branch graft system having lateral openings in the main graft. The main graft can be positioned within the main blood vessel such as the aorta so that the lateral openings (also referred to herein as fenestrations) can be aligned with the branch blood vessels, to allow blood to flow through the openings in the main graft and into the branch vessels. Because the axial and angular position of the branch blood vessels can vary from one patient's anatomy to the next, the embodiments of the graft systems disclosed herein can allow a surgeon to adjust the position of the fenestrations so as to align the fenestrations with the branch vessels so that blood flow through the branch vessels is not obstructed by the main graft.
• The branch graft system can comprise a tubular expandable main body and at least one fenestration or at least one branch graft at any desired location. The main graft body and/or the branch graft can be made from an expandable material, such as but not limited to ePTFE. In some embodiments, the main graft can have two fenestrations or branch grafts formed therein at generally diametrically opposed locations or at positions that are offset from the diametrically opposed positions. Depending on the particular patient's anatomy, other cut-outs, scallops, or fenestrations, such as but not limited to a fenestration for the superior mesenteric artery (“SMA”), can be formed in the main graft depending on the patient's anatomy and position of the graft.
• Some embodiments of the main graft body can have a tubular shape and can have a diameter that can be significantly larger than the diameter of the target vessel into which the graft is intended to be deployed. As will be described in greater detail below, the oversized diameter of the main graft can provide excess or slack graft material in the main graft to allow the fenestrations to each be moved in a plurality of axial and/or angular directions so that the fenestrations can be aligned with the branch arteries.
• In some embodiments, one or more branch grafts can be supported by the main graft body adjacent to the one or more openings that can be formed in the main graft body. The diameter of each branch graft can be sufficiently small so as to allow each branch graft to be manipulated into the desired vascular position by moving the branch graft over a guidewire. The branch graft can be expanded to the diameter of the branch vessel by mechanical means, which can be a dilation balloon.
• Some embodiments are directed to endoluminal prostheses, comprising a first stent portion and a second stent portion, a main graft body comprising a first portion, a second portion, and a third portion, the second portion having a cross-sectional size that is significantly larger than a cross-sectional size of the first portion or the third portion, and also significantly larger than a cross-sectional size of the target vessel, and one or more openings formed in the second portion of the main graft body. In some embodiments, the first portion of the main graft body can be attached to the first stent portion and the third portion of the main graft body can be attached to the second stent portion. Further, prosthesis can be configured such that the second portion of the main graft body is not directly attached to the first stent portion, the second stent portion, or any other internal support structure, or so that the second portion has a minimal number of attachment points thereto.
• Some embodiments are directed to endoluminal prostheses, comprising a main graft body comprising a first portion, a second portion, and a third portion, the second portion having a cross-sectional size that is significantly larger than a cross-sectional size of the first portion or the third portion, and also significantly larger than a cross-sectional size of the target vessel, and one or more openings formed in the second portion of the main graft body. In some embodiments, the first portion of the main graft body can be radially supported by a first support member and the third portion of the main graft body can be radially supported by a second support member. In some embodiments, the second portion of the main graft body can be free of radial support from a stent or other support member.
• Some embodiments are directed to endoluminal prostheses, comprising a main graft body comprising a first portion, a second portion, and a third portion, a support member positioned within the main graft body, the support member having a first support portion, a second support portion, and a third support portion, and one or more openings formed in the second portion of the main graft body. In some embodiments, the first portion of the main graft body can be attached to the first support portion of the support member at a first number of attachment points, the second portion of the main graft body can be attached to the second support portion of the support member at a second number of attachment points, and the third portion of the main graft body can be attached to the third support portion of the support member at a third number of attachment points. Without limitation, the third number of attachment points can be less than the first number of attachment points and the third number of attachment points. In some embodiments, the entirety of the second portion can have a cross-sectional size that is significantly larger than a cross-sectional size of the first portion or the third portion, and also significantly larger than a cross-sectional size of the target vessel.
• Some embodiments or arrangements are directed to methods for deploying an endoluminal prosthesis, comprising advancing a catheter supporting the endoluminal prosthesis therein through a patient's vasculature to a target vessel location, advancing one or more catheters through one or more fenestrations foamed in the main graft body and into one or more branch vessels in the patient's vasculature, at least partially expanding at least the second portion of the main graft body, and substantially aligning the one or more fenestrations formed within the second portion of the main graft body with the one or more branch vessels by moving the one or more fenestrations in a circumferential and/or axial direction toward the ostium of the one or more branch vessels. In some embodiments or arrangements, the prosthesis can have a main graft body comprising a first portion, a second portion, and a third portion. Further, in some embodiments or arrangements, the second portion of the main graft body can have a cross-sectional size that is significantly larger than a cross-sectional size of the first portion and the third portion, and also significantly larger than a cross-sectional size of the target vessel.
• Some embodiments or arrangements are directed to methods for deploying a graft in a patient's blood vessel having at least a first branch blood vessel, comprising advancing a delivery catheter into a blood vessel, the delivery catheter supporting a fenestrated prosthesis comprising a main graft body therein, and exposing at least one branch sheath. The branch sheath can be positioned within the delivery catheter so as to extend from a main lumen of the prosthesis through a first opening formed through a wall of the prosthesis. Some embodiments can further comprise advancing an angiographic catheter into the branch sheath and cannulating a first target branch vessel before expanding the main graft body of the prosthesis.
• Some embodiments or arrangements are directed to methods for deploying a fenestrated prosthesis in a patient's blood vessel having at least a first branch blood vessel, comprising advancing a delivery catheter into a blood vessel, exposing at least one guide sheath, the guide sheath being positioned within the delivery catheter so as to extend from a main lumen of the prosthesis through a first opening formed through a wall of the prosthesis, and advancing an angiographic catheter through the guide sheath and cannulating a first target branch vessel before completely removing the second restraint. In some embodiments, the delivery catheter can support the fenestrated prosthesis having a main graft body and at least one fenestration extending through the main graft body, a first restraint restraining a proximal portion of the prosthesis, and a second restraint restraining a distal portion of the prosthesis, the distal portion of the prosthesis being closer to a proximal portion of the delivery catheter than the proximal portion of the prosthesis.
• Some embodiments or arrangements are directed to methods for deploying a fenestrated prosthesis in a patient's blood vessel having at least a first branch blood vessel, comprising advancing a delivery catheter into a blood vessel, exposing at least one guide sheath, the guide sheath being positioned within the delivery catheter so as to extend from a main lumen of the prosthesis through a first opening formed through a wall of the prosthesis, and advancing the guide sheath into a first target branch vessel before completely removing the second restraint. In some embodiments, the delivery catheter can support the fenestrated prosthesis, and the fenestrated prosthesis can have a main graft body and at least one fenestration therein, a first restraint restraining a proximal portion of the prosthesis, and a second restraint restraining a distal portion of the prosthesis, the distal portion of the prosthesis being closer to a proximal portion of the delivery catheter than the proximal portion of the prosthesis,
• Some embodiments or arrangements are directed to delivery systems for deploying an endoluminal prosthesis, comprising a first restraint configured to restrain a portion of the prosthesis, a second restraint configured to restrain a second portion of the prosthesis, a first opening through a wall of the prosthesis, a first guide sheath extending from a proximal end of the delivery system into a main lumen of the endoluminal prosthesis and through the first opening in the wall of the prosthesis, a first stent configured to support the first portion of the endoluminal prosthesis, and a second stent configured to support the second portion of the endoluminal prosthesis, wherein the guide sheath is moveable before removing the first and second restraints. The first opening can be positioned between the first and second portions.
• Some embodiments or arrangements are directed to endoluminal prostheses comprising a main graft body defining a flow lumen therethrough, a first opening passing through a wall of the main graft body, and a first support member supported by the main graft body and overlapping an edge of the first opening, the first support member being configured to increase the tear resistance of the main graft body adjacent to the first opening.
• Some embodiments or arrangements are directed to methods for forming an endoluminal prosthesis having at least one reinforced fenestration in a main portion thereof, comprising forming a graft body having a tubular main body portion, forming a first opening through a wall of the main body portion, the first opening having a first state in which the first opening is substantially unstretched and a second state in which the first opening is stretched so that a size of the first opening increases, advancing a tubular member partially through the first opening, and fastening a first end portion and a second end portion of the tubular member to the wall of the main body portion adjacent to the first opening so that the tubular member completely overlaps an edge of the first opening.
• In any of the embodiments disclosed (directly or by incorporation by reference) herein, main graft body, branch grafts, or any other component of the endoluminal prostheses or deployment systems disclosed herein can have at least one radiopaque suture or marker attached thereto to assist with the placement of such components.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a partial section view of a patient's vasculature illustrating an embodiment of an endoluminal prosthesis deployed in the desired position within the patient's vasculature.
• FIG. 2 is a side view of the endoluminal prosthesis illustrated inFIG. 1.
• FIG. 3 is a cross-sectional view of the embodiment of the endoluminal prosthesis deployed in the patient's anatomy, taken through line3-3 inFIG. 1, before the fenestrations have been aligned with the respective branch vessels.
• FIG. 4 is a cross-sectional view of the embodiment of the endoluminal prosthesis deployed in the patient's anatomy, taken through line3-3 inFIG. 1, after the fenestrations have been aligned with the respective branch vessels.
• FIG. 5 is a partial section view of a patient's vasculature illustrating another embodiment of an endoluminal prosthesis deployed in the desired position within the patient's vasculature.
• FIGS. 6-12 are side views of additional embodiments of endoluminal prostheses.
• FIG. 12A is an enlarged side view of the embodiment of the endoluminal prosthesis illustrated inFIG. 12, defined bycurve12A-12A inFIG. 12.
• FIG. 13 is a side view of another embodiment of an endoluminal prosthesis.
• FIG. 14 is a top view of the embodiment of the endoluminal prosthesis shown inFIG. 14.
• FIG. 15 is a side view of another embodiment of an endoluminal prosthesis.
• FIG. 16 is an enlargement of a portion of the embodiment of an endoluminal prosthesis shown inFIG. 15, defined by curve16-16, illustrating the adjustability of a branch graft.
• FIG. 17 is a side view of another embodiment of an endoluminal prosthesis with guidewires advanced through each of the branch grafts.
• FIG. 18 is a side view of the embodiment of the endoluminal prosthesis shown inFIG. 17 with guidewires advanced through each of the branch grafts, showing the endoluminal prosthesis being loaded within a delivery catheter.
• FIG. 19 is a side view of the embodiment of the endoluminal prosthesis shown inFIG. 17 with guidewires advanced through each of the branch grafts, showing the endoluminal prosthesis fully loaded within a delivery catheter and being advanced along guidewires pre-wired in the patient's vasculature.
• FIG. 20 is a side view of another embodiment of a delivery catheter that can be used to deploy at least some of the embodiments of the endoluminal prostheses disclosed herein, showing the endoluminal prosthesis being loaded within a delivery catheter.
• FIG. 21 is an enlarged side view of a portion of the embodiment of a delivery catheter illustrated inFIG. 20, showing the endoluminal prosthesis loaded within a delivery catheter.
• FIG. 22A is a section view of an embodiment of a distal tip that can be used with the embodiment of the delivery catheter that is illustrated inFIG. 20, taken throughline22A-22A inFIG. 20.
• FIG. 22B is a section view of another embodiment of a distal tip that can be used with the embodiment of the delivery catheter that is illustrated inFIG. 20, taken throughline22B-22B inFIG. 20.
• FIG. 23A is a section view of the embodiment of the delivery catheter shown inFIG. 20, taken throughline23A-23A inFIG. 20.
• FIG. 23B is a section view of the embodiment of the delivery catheter shown inFIG. 20, taken throughline23B-23B inFIG. 20.
• FIG. 24 is a side view of another embodiment of a delivery catheter showing a delivery catheter being advanced distally past a bifurcated graft and showing guidewires being advanced into the renal arteries.
• FIG. 25 is a side view of the embodiment of the delivery catheter shown inFIG. 24, showing biased guidewires being advanced into the renal arteries.
• FIG. 26 is a side view of the embodiment of the delivery catheter shown inFIG. 24, showing the embodiment of the endoluminal prosthesis being deployed within the target vessel region.
• FIG. 27 is a side view of the embodiment of the delivery catheter shown inFIG. 24, showing the endoluminal prosthesis after the distal portion of the endoluminal prosthesis has been deployed within the bifurcated prosthesis.
• FIG. 28 is a side view of the embodiment of the delivery catheter shown inFIG. 24, showing the endoluminal prosthesis after the distal portion of the endoluminal prosthesis has been deployed within the bifurcated prosthesis.
• FIG. 29 is a side view of another embodiment of a delivery catheter showing a delivery catheter being advanced distally past renal arteries in the thoracic aorta region of a patient's vasculature.
• FIG. 30 is a side view of an endoluminal prosthesis that can be deployed using the embodiment of the delivery catheter shown inFIG. 29.
• FIG. 31 is a section view of an embodiment of a guidewire, showing the guidewire in a collapsed configuration.
• FIG. 32 is a section view of the embodiment of the guidewire shown inFIG. 31, showing the guidewire in an expanded configuration.
• FIGS. 33 and 34 illustrate a pair of guidewires positioned within the patient's vasculature such that the distal end portions of the guidewires are secured within the patient's branch vessels.
• FIG. 35 is a side view of another embodiment of a guidewire, showing the guidewire in an expanded configuration.
• FIG. 36 is a side view of another embodiment of a guidewire, showing the guidewire in an expanded configuration.
• FIG. 37 is a section view of another embodiment of a guidewire, showing the guidewire in an expanded configuration.
• FIG. 38 is a side view of another embodiment of an endoluminal prosthesis, showing the branch grafts in an inverted position inside the main body of the prosthesis.
• FIG. 39 is a side view of the embodiment of the prosthesis shown inFIG. 38, showing the branch grafts in an inverted position inside the prosthesis and showing an embodiment of an angiographic catheter being advanced through each of the inverted branch grafts and the fenestrations.
• FIG. 40 is a section view of the embodiment of the prosthesis shown inFIG. 40, taken through line40-40 inFIG. 39.
• FIG. 41 is a section view of the embodiment of the prosthesis shown inFIG. 40, taken through line41-41 inFIG. 39.
• FIG. 42 is a section view of the embodiment of the prosthesis shown inFIG. 40, after the branch grafts have been advanced through the fenestrations in the main body of the embodiment of the prosthesis shown inFIG. 38.
• FIG. 43A is a side view of another embodiment of a catheter system comprising an embodiment of an introducer catheter and an embodiment of a delivery catheter.
• FIG. 43B is a perspective view of the embodiment of a catheter system illustrated inFIG. 43A, showing the outer sheath in a partially retracted position.
• FIG. 44 is a perspective view of the embodiment of the introducer catheter shown inFIG. 43.
• FIG. 45 is an exploded view of the embodiment of the introducer catheter shown inFIG. 43.
• FIG. 46 is a perspective view of the embodiment of the delivery catheter shown inFIG. 43.
• FIG. 47 is an exploded view of the embodiment of the delivery catheter shown inFIG. 43.
• FIG. 48 is a section view of a portion of the embodiment of the delivery catheter shown inFIG. 43, defined by curve48-48 shown inFIG. 43A.
• FIG. 49A is a section view of the embodiment of the delivery catheter shown inFIG. 43, defined by theline49A-49A shown inFIG. 48.
• FIG. 49B is a section view of the embodiment of the delivery catheter shown inFIG. 43, defined by theline49B-49B shown inFIG. 48.
• FIG. 50 is a side view of the embodiment of the catheter system shown inFIG. 43, showing the outer sheath in a partially retracted position.
• FIG. 51 is an enlarged side view of the embodiment of the catheter system shown inFIG. 43, defined by curve51-51 shown inFIG. 50, showing the outer sheath in a partially retracted position.
• FIG. 52 is an enlarged side view of the embodiment of the catheter system shown inFIG. 43, defined by curve52-52 shown inFIG. 50, showing the outer sheath in a partially retracted position and the proximal sheath in a partially advanced position.
• FIG. 53 is a side view of the embodiment of the catheter system shown inFIG. 43, showing the outer sheath in a partially retracted position and the embodiment of one branch sheath and one push catheter in a partially advanced position.
• FIG. 54 is a section view of a portion of a patient's vasculature, showing the embodiment of the delivery catheter illustrated inFIG. 43A being advanced through a patient's abdominal aorta.
• FIG. 55 is a section view of a portion of a patient's vasculature, showing the embodiment of the delivery catheter illustrated inFIG. 43A and an angiographic catheter being advanced through a branch sheath of the delivery catheter toward a branch vessel.
• FIG. 56 is a section view of a portion of a patient's vasculature, showing the embodiment of the delivery catheter illustrated inFIG. 43A and the branch sheaths of the delivery catheter being advanced into a patient's branch arteries.
• FIG. 57 is a section view of a portion of a patient's vasculature, showing an embodiment of a distal sheath of the embodiment of the delivery catheter illustrated inFIG. 43A being advanced to deploy a proximal portion of the prosthesis.
• FIG. 58 is a section view of a portion of a patient's vasculature, showing an embodiment of a peelable sheath of the embodiment of the delivery catheter illustrated inFIG. 43A being removed to deploy a distal portion of the prosthesis.
• FIG. 59 is a section view of a portion of a patient's vasculature, showing an embodiment of a push catheter of the embodiment of the delivery catheter illustrated inFIG. 43A advancing an inner wall of the prosthesis adjacent to a fenestration toward an ostium of the target branch vessel.
• FIG. 60 is a section view of a portion of a patient's vasculature, showing an embodiment of a branch stent being advanced into the target branch vessel.
• FIG. 61 is a section view of a portion of a patient's vasculature, showing the embodiment of the branch stent ofFIG. 60 being expanded in the target branch vessel and flared.
• FIGS. 62A and 62B are perspective views of an embodiment of a prosthesis having one or more fenestrations therein, the graft being shown in dashed lines inFIG. 62B for clarity.
• FIG. 63 is a top view of the embodiment of the prosthesis ofFIG. 62.
• FIG. 64 is an enlarged view of a portion of the embodiment of the prosthesis ofFIG. 62, defined by curve64-64 ofFIG. 62B.
• FIG. 65 is a partially exploded schematic representation of the prosthesis embodiment shown inFIG. 62.
• FIG. 66 is an enlarged side view of the embodiment of the fenestration shown inFIG. 65, defined by curve66-66 ofFIG. 65.
• FIG. 67 is an enlarged section view of the embodiment of the fenestration illustrated inFIG. 65, showing the end portions of the embodiment of the tubular member being pulled back against the graft.
• FIG. 68 is an enlarged section view of the embodiment of the fenestration shown inFIG. 65, showing the end portions of the embodiment of the tubular member stitched to the graft.
• FIG. 69 is a side view of the embodiment of the stent shown inFIG. 62, perpendicular to an axis projecting through the fenestration.
• FIG. 70 is a side view of the embodiment of the stent shown inFIG. 62, along an axis projecting through the fenestration.
• FIGS. 71-85 are side views of additional embodiments of prostheses having or more enlarged portions and one or more fenestrations therein.
• FIG. 86 illustrates calculations regarding the theoretical axial adjustability of at least some embodiments of the grafts disclosed herein.
• FIG. 87 illustrates calculations regarding the theoretical angular or radial adjustability of at least some embodiments of the grafts disclosed herein.
DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS
• The following detailed description is now directed to certain specific embodiments of the disclosure. In this description, reference is made to the drawings wherein like parts are designated with like numerals throughout the description and the drawings.
• Some embodiments described herein are directed to systems, methods, and apparatuses to treat lesions, aneurysms, or other defects in the aorta, including, but not limited to, the thoracic, ascending, and abdominal aorta, to name a few. However, the systems, methods, and apparatuses may have application to other vessels or areas of the body, or to other fields, and such additional applications are intended to form a part of this disclosure. For example, it will be appreciated that the systems, methods, and apparatuses may have application to the treatment of blood vessels in animals. In short, the embodiments and/or aspects of the endoluminal prosthesis systems, methods, and apparatuses described herein can be applied to other parts of the body or may have other applications apart from the treatment of the thoracic, ascending, and abdominal aorta. And, while specific embodiments may be described herein with regard to particular portions of the aorta, it is to be understood that the embodiments described can be adapted for use in other portions of the aorta or other portions of the body and are not limited to the aortic portions described.
• As will be described, any of the graft embodiments disclosed herein can be configured to have excess or slack graft material in at least a portion thereof relative to the stent or support member which supports the graft. In some embodiments, without limitation, the excess or slack material can result from either an enlarged diametric portion of the graft, excess length of the graft material relative to a stent or other support structure, or a combination of both the enlarged diametric portion of the graft and excess length of the graft material. For example, without limitation, the excess graft material can form a bulge or other enlargement in the graft in the approximate location of one or more fenestrations formed through the graft material. The excess or slack material along the circumference of the graft (for example, without limitation, in the enlarged portion of the graft) can allow for circumferential and/or axial movement of the graft material and, hence, can allow for circumferential and/or axial movement of the one or more fenestrations, relative to the stent and the ostium of the patient's branch vessels. Therefore, in some embodiments, the diameter of the graft at and/or adjacent to the location of one or more fenestrations through the graft material can be larger than the local diameter of the target vessel. Similarly, in some embodiments, the diameter of the graft at and/or adjacent to the location of one or more fenestrations can be larger than the diameter of the non-enlarged portion of the graft material.
• For example, any of the embodiments disclosed herein can be configured such that the graft has an enlarged or excess slack portion at or adjacent to the location of the fenestrations, wherein such enlarged or excess slack portion is free of attachment points or has only a minimal number of attachment points to the stent or support structure radially adjacent to the enlarged or excess slack portion. In some embodiments, this can result in both freedom of circumferential and axial movement of the fenestrations, thereby improving the positional adjustability of the fenestrations. In some embodiments, the enlarged or excess slack portions of the graft can be radially unsupported by the stent or support member, or can be supported by a stent or support member or by connectors connecting support members positioned axially adjacent to the enlarged or excess slack portion. Accordingly, any of the graft embodiments described herein can be configured to have excess circumferential or longitudinal material at any portion of the graft to increase the positional adjustability of one or more fenestrations formed in the graft.
• Further, any of the graft embodiments disclosed herein, including those with diametrically enlarged portions, can have excess graft material in an axial direction. The excess or slack material along the length of the graft can increase the circumferential and/or axial movement of the graft material adjacent to the one or more fenestrations formed in the graft material. Accordingly, in some embodiments, the length of the graft material between the proximal and distal attachment points to the stent can be longer than that of the stent between the proximal and distal attachment points. Or, in some embodiments, the graft material in a mid portion of the graft, including on either side of the enlarged portion, can have an increased length relative to the stent adjacent to such graft portion.
• As can be seen in the table of measurement data below, the relative position of a patient's left and right renal arteries, a patient's superior mesenteric artery (“SMA”), and a patient's celiac artery can vary widely. For this reason, the adjustability of one or more fenestrations within the graft material can greatly improve the positional ease and accuracy of the fenestrations relative to the patient's branch arteries during deployment of the graft.

• Measurement
  Description	Average	Minimum	Maximum

  Distance from right	14.0	mm	−8.9	mm	42.9	mm
  renal to SMA
  Distance from left	16.9	mm	−8.0	mm	47.0	mm
  renal to SMA
  Distance from	−10.6	mm	−36.0	mm	23.6	mm
  celiac to SMA
  Angle from right	72.3	degrees	32.1	degrees	115.9	degrees
  renal to SMA
  Angle from left	79.0	degrees	30.9	degrees	118.4	degrees
  renal to SMA

  Angle between left and	151.3	degrees
  right renal arteries

• FIG. 1 is a partial section view of a patient's vasculature illustrating an embodiment of an endoluminal prosthesis deployed in the desired position within the patient's vasculature. Although the prostheses disclosed herein can be adapted for deployment in any suitable vessels in the body, some embodiments are described as being deployed in particular vessels or vascular regions within a patient's body. However, the particular prostheses illustrated are not limited to deployment in only one particular vessel or vascular region. In some embodiments, the embodiments shown can be adapted for deployment in other suitable vessels within a patient's body, including the aorta, thoracic artery, renal arteries, iliac arteries, etc.
• As an example, with reference toFIG. 1, an embodiment of an endoluminal prosthesis is shown deployed in a patient'saorta10. Ananuerysmic sac10A is also shown. For reference, also illustrated are a patient's first and secondrenal arteries12,14, respectively, and a patient's ipsilateral and contralateraliliac arteries16,18, respectively.FIG. 2 is a side view of theendoluminal prosthesis20 illustrated inFIG. 1. The embodiment of theendoluminal prosthesis20 illustrated inFIGS. 1 and 2 can have amain graft body22, afirst fenestration24, and asecond fenestration26. In some embodiments, as in the illustrated embodiment, the main graft can be a bifurcated graft having a firstbifurcated branch28 and a secondbifurcated branch30 for placement in the ipsilateral and contralateral iliac arteries.
• In some embodiments, themain graft body22 can have a generally cylindrical, tubular shape. Theendoluminal prosthesis20 can be formed from any suitable material, such as, but not limited to, ePTFE. Some embodiments of theendoluminal prosthesis20 can be formed from an expandable material. Theendoluminal prosthesis20 can be formed such that themain graft body22 can be significantly larger than the target vessel into which themain graft body22 is to be deployed. As illustrated inFIG. 1, the target vessel can be the aortic artery, and the endoluminal prosthesis can be deployed so as to span across an aneurysm in the abdominal aortic.
• In any of the graft embodiments disclosed herein, the diameter of the graft body (such as without limitation the main graft body22) or an enlarged portion of any embodiment of a graft body disclosed herein can be approximately 30% larger than the diameter of the target vessel or the diameter of the non-enlarged portion of the graft body. In some embodiments, the diameter of the graft body (such as without limitation the main graft body22) or an enlarged portion of any embodiment of a graft body disclosed herein can be less than approximately 20%, or from approximately 20% to approximately 50% or more, or from approximately 25% to approximately 40% larger than the target vessel or the diameter of the non-enlarged portion of the graft body, or to or from any values within these ranges.
• Further, in any of the graft embodiments disclosed herein, at least a portion of the graft material adjacent to the one or more fenestrations or openings can be free to translate in a circumferential or axial direction relative to the stent that the graft is supported by. For example, without limitation, particular portions such as the end portions of the graft material can be sutured or otherwise fastened to the stent, while a mid portion of the graft having one or more fenestrations therethrough can be unattached to the stent so that such mid portion can be free to translate relative to the stent and, hence, permit the adjustability of the fenestrations relative to the stent. In this configuration, the fenestrations can be adjusted to align with the ostium of the patient's branch vessels.
• As one non-limiting example, the diameter of themain graft body22 configured for placement in an approximately 26 mm vessel can be approximately 34 mm. Therefore, in some embodiments, the diameter of themain graft body22 can be approximately 8 mm larger than the diameter of the target vessel. In some embodiments, the diameter of themain graft body22 can be between approximately 2 mm and approximately 14 mm, or between approximately 4 mm and approximately 12 mm, or between approximately 6 mm and approximately 10 mm larger than the diameter of the target vessel, or to or from any values within these ranges.
• The oversized diameter of themain graft body22 can provide excess or slack graft material in themain graft body22 such that thefenestrations24,26 can each be moved in an axial or angular direction to align thefenestrations24,26 with the branch vessels arteries, as will be described in greater detail below.
• As described above, two or more fenestrations can be formed in themain graft body22 at any desired location. With reference toFIG. 2, the twofenestrations24,26 can be formed at generally diametrically opposed locations. However, any number of fenestrations can be formed in themain graft body22 at any desired locations. Additionally, scallops or cutouts can be formed in the distal end portion or at any suitable location in themain graft body22, the scallops or cutouts being configured to prevent obstruction of other arteries branching off of the main vessel into which themain graft body22 is to be deployed. For example, in some embodiments, anadditional fenestration32 can be formed in a distal portion of themain graft body22. Thefenestration32 can be foamed so as to align with a patient's SMA
• FIG. 3 is a cross-sectional view of the embodiment of theendoluminal prosthesis20 deployed in the patient's anatomy, taken through line3-3 inFIG. 1, before thefenestrations24,26 have been aligned with the respective branch vessels, for examplerenal arteries12,14. With reference toFIG. 3, the main graft body22 (which can be oversized) has been deployed in the target vessel. In some embodiments, after themain graft body22 has been deployed in the target vessel, because themain graft body22 can have a larger diameter than the vessel diameter, folds, wrinkles, or other undulations (collectively referred to as folds)34 can form in themain graft body22 about the circumference of themain graft body22. Thefolds34 can form in themain graft body22 as a result of the fact that there can be excess or slack material in themain graft body22 after themain graft body22 has been deployed in the target vessel.
• In some embodiments, at least a portion of themain graft body22 can have undulations, folds, bends, corrugations, or other similar features in the axial direction therein when themain graft body22 is in a relaxed state (i.e., before the graft has been deployed). In some embodiments, a middle portion of the graft can have undulations, folds, bends, corrugations or other similar features while the distal or upstream portion defines a smooth contour
• FIG. 4 is a cross-sectional view of the embodiment of theendoluminal prosthesis20 deployed in the patient's anatomy, taken through line3-3 inFIG. 1, after thefenestrations24,26 have been aligned with the respective branch vessels. With reference toFIG. 4, the oversizedmain graft body22 can be aligned with the patient's anatomy by movingfenestration24 to align thefenestration24 with the respective branch vessel and by moving thefenestration26 to align thefenestration26 with the other respective branch vessel. For example, thefenestration24 can be drawn closer to thefenestration26, thereby gathering slack material or folds34 in afirst portion22aof themain graft body22 and partially or fully removing the slack material or folds from asecond portion22bof themain graft body22.
• After themain graft body22 has been positioned within the patient's anatomy such that thefenestrations24,26 have been aligned with the respective branch vessels, a covered stent, a bare wire stent, or any other suitable stent or anchoring device can be deployed within the main graft to secure the graft in the desired location (not illustrated). In some embodiments, a bare metal stent deployed within themain graft body22 can compress thefolds34 that are formed in themain graft body22, if any, against the wall of the vessel and secure themain graft body22 and thefenestrations24,26 in the desired locations.
• Alternatively, a supra renal stent can be deployed at a distal or upper portion of the main graft body to secure the distal or upper portion of the main graft body in the desired location within the patient's vasculature, and one or moreaxial springs40 can be anchored to the main graft body to provide axial or column strength to the main graft body. Thesprings40 can have a helical shape, as illustrated, and can have any suitable size, length, pitch, or diameter. However, such helical shape is not required. In some embodiments, thesprings40 can have any suitable shape, including a straight, flat, round, or non-round shape. Thesprings40 can be formed from any suitable biocompatible material, such as without limitation stainless steel, Nitinol, or suitable metalic or polymeric materials.
• FIG. 5 is a partial section view of a patient's vasculature illustrating another embodiment of anendoluminal prosthesis20′ deployed in the desired position within the patient's vasculature wherein themain graft body22′ can have a suprarenal stent38 deployed within the upper or distal end portion of themain graft body22′ and one or moreaxial springs40 secured to themain graft body22′. Thesprings40 can be secured to themain graft body22′ using any suitable fasteners or method, such as without limitation, sutures or adhesive.
• In some embodiments, any of the embodiments of the endoluminal prostheses disclosed herein can be formed such that one or more portions of the main graft body have an enlarged diameter, while one or more other portions of the main graft body can have a reduced diameter as compared to the enlarged diameter. For example, with reference toFIG. 6, which is a side view of another embodiment of anendoluminal prosthesis60, theendoluminal prosthesis60 can have amain graft body62 andfenestrations64,66 formed therein. In some embodiments, anadditional fenestration68 can be formed in themain graft body62 to accommodate blood flow to the SMA or otherwise. With reference toFIG. 6, a first orupper portion62aof themain graft body62 can have a first diameter while a second orlower portion62bcan have a second diameter. In some embodiments, as in the illustrated embodiment, thefirst portion62acan have a smaller diameter than thesecond portion62bof themain graft body62. Accordingly, to accommodate adjustability of thefenestrations64,66, thefenestrations64,66 can be formed in the second orenlarged portion62bof themain graft body62.
• Thefirst portion62acan have any diameter suitable for the size of the target vessel. Additionally, thesecond portion62bcan have an enlarged diameter within any of the ranges described above with respect to themain graft body22. For example, without limitation, theendoluminal prosthesis60 can be configured for deployment in a 26 mm target vessel, wherein thefirst portion62acan have an approximately 28 mm or any other suitable diameter, and thesecond portion62bcan have an approximately 34 mm or any other suitable enlarged diameter so as to allow for the adjustability of thefenestrations64,66. As illustrated inFIG. 6, the diameter of themain graft body62 in thesecond portion62bcan transition from the diameter of thefirst portion62ato the diameter of the remainder of thesecond portion62b.
• FIG. 7 is a side view of another embodiment of an endoluminal prosthesis70 having amain graft body72 andfenestrations74,76 formed therein. In some embodiments, an additional fenestration orcutout78 can be formed in themain graft body72 to accommodate blood flow to the SMA or otherwise. With reference toFIG. 7, a first orupper portion72aof themain graft body72 can be tapered from a first to a second diameter, while a second orlower portion72bcan have a second diameter. In some embodiments, as in the illustrated embodiment, thefirst portion72acan have a smaller diameter than thesecond portion72bof themain graft body72. Accordingly, to accommodate adjustability of thefenestrations74,76, thefenestrations74,76 can be formed in the second orenlarged portion72bof themain graft body72.
• Thefirst portion72acan have any suitable first diameter for the size of the target vessel. Additionally, thesecond portion72bcan have an enlarged diameter within any of the ranges described above. For example, without limitation, the endoluminal prosthesis70 can be configured for deployment in a 26 mm target vessel, wherein thefirst portion72acan have an approximately 28 mm first diameter that tapers outwardly to an approximately 34 mm second diameter, and thesecond portion72bcan have an approximately 34 mm diameter so as to allow for the adjustability of thefenestrations74,76.
• FIG. 8 is a side view of another embodiment of anendoluminal prosthesis80 having amain graft body82 andfenestrations84,86 formed therein. In some embodiments, anadditional fenestration88 can be formed in themain graft body82 to accommodate blood flow to the SMA or otherwise. With reference toFIG. 8, a first orupper portion82aof themain graft body82 can have a first diameter, a second ormiddle portion82bcan have a second diameter, and a third orlower portion82ccan have a third diameter. In some embodiments, as in the illustrated embodiment, thefirst portion82acan have a smaller diameter than thesecond portion82bof themain graft body82. Additionally, thethird portion82ccan have a smaller diameter than thesecond portion82bof themain graft body82. In some embodiments, thethird portion82ccan have the same diameter as compared to thefirst portion82a.Accordingly, to accommodate adjustability of thefenestrations84,86, thefenestrations84,86 can be formed in the second orenlarged portion82bof themain graft body82. Thesecond portion82bcan have a generally curved surface, or can define a generally cylindrical surface that conically or curvedly tapers to the diameter of the first andthird portions82a,82c.
• Thefirst portion82acan have any suitable first diameter for the size of the target vessel. Additionally, as mentioned, thesecond portion82bcan have an enlarged diameter within any of the ranges described above. For example, without limitation, theendoluminal prosthesis80 can be configured for deployment in a 26 mm target vessel, wherein thefirst portion82acan have an approximately 28 mm diameter, thesecond portion82bcan have an approximately 34 mm diameter so as to allow for the adjustability of thefenestrations84,86, and thethird portion82ccan have an approximately 28 mm diameter.
• Please note that any of the endoluminal prostheses disclosed or described herein can be bifurcated or non-bifurcated, and can be formed from any suitable material, such as but not limited to ePTFE. Additionally, any of the deployment procedures described herein or any other suitable deployment procedures currently known or later developed that are suitable for such endoluminal prostheses can be used to deploy any of the endoluminal prostheses described herein. Further, any of the endoluminal prostheses can be secured to the target vessel wall using covered stents, bare metal stents, supra renal stents, springs, anchors, or any other suitable medical device or fasteners. For example, without limitation, with reference toFIG. 9, which is a side view of another embodiment of anendoluminal prosthesis90, theendoluminal prosthesis90 can be a bifurcated prosthesis. As illustrated therein, themain graft body92 can have threeportions92a,92b,92cof varying diameters.
• Further, in any of the graft embodiments disclosed herein, at least a portion of the graft material adjacent to the one or more fenestrations or openings, such as the graft material in theenlarged section92b,can be free to translate in a circumferential or axial direction relative to the stent that the graft is supported by. For example, without limitation, particular portions of the graft material, such as the end portions of the graft material, can be sutured or otherwise fastened to the stent, while a mid or enlarged portion of the graft having one or more fenestrations therethrough can be unattached to the stent so that such portion can be free to translate relative to the stent. This configuration can improve the adjustability of the graft material and, hence, the fenestrations, relative to the stent, permitting the fenestrations to be adjusted to align with the ostium of the patient's branch vessels.
• Additionally, as mentioned above, any of the embodiments of the endoluminal prostheses disclosed herein (which is meant throughout this specification to include the embodiments incorporated herein by reference) can be formed with a branch graft adjacent to one or more of the openings or fenestrations formed in the main graft body. For example, with reference toFIG. 10, which is a side view of another embodiment of anendoluminal prosthesis100, theendoluminal prosthesis100 can have amain graft body102 andbranch grafts104,106 supported by themain graft body102. In some embodiments, anadditional fenestration108 can be formed in themain graft body102 to accommodate blood flow to the SMA or otherwise. Alternatively, an additional branch graft (not illustrated) can be supported by themain graft body102 to accommodate the blood flow to the SMA
• With reference toFIG. 10, a first orupper portion102aof themain graft body102 can have a first diameter, a second ormiddle portion102bcan have a second diameter, and a third orlower portion102ccan have a third diameter. Themain graft body102 can have any suitable shape, including any of the shapes disclosed elsewhere herein. In some embodiments, as in the illustrated embodiment, thefirst portion102acan have a smaller diameter than thesecond portion102bof themain graft body102. Additionally, thethird portion102ccan have a smaller diameter than thesecond portion102bof themain graft body102. In some embodiments, thethird portion102ccan have the same diameter as compared to thefirst portion102a.Accordingly, to accommodate adjustability of thebranch grafts104,106, thebranch grafts104,106 can be supported by the second orenlarged portion102bof themain graft body102.
• Thefirst portion102acan have any suitable first diameter for the size of the target vessel. Additionally, as mentioned, thesecond portion102bcan have an enlarged diameter within any of the ranges described above. For example, without limitation, theendoluminal prosthesis100 can be configured for deployment in a 26 mm target vessel, wherein thefirst portion102acan have an approximately 28 mm diameter, thesecond portion102bcan have an approximately 34 mm diameter so as to allow for the adjustability of thefenestrations104,106, and thethird portion102ccan have an approximately 28 mm diameter.
• In some embodiments, thebranch grafts104,106 can be integrally formed with themain graft body12. Alternatively, thebranch graft portions104,106 can be formed separately and later attached, adhered, sutured, or otherwise fastened or supported by themain graft body102. In some embodiments, themain graft body102 can have fenestrations or openings in place of thebranch grafts104,106.
• Additionally, as mentioned above, any of the embodiments of the endoluminal prostheses disclosed herein can be formed with a branch graft adjacent to one or more of the openings or fenestrations formed in the main graft body. For example, with reference toFIG. 10, which is a side view of another embodiment of anendoluminal prosthesis100, theendoluminal prosthesis100 In some embodiments, anadditional fenestration108 can be formed in themain graft body102 to accommodate blood flow to the SMA or otherwise. Alternatively, an additional branch graft (not illustrated) can be supported by themain graft body102 to accommodate the blood flow to the SMA
• With reference toFIG. 10, a first orupper portion102aof themain graft body102 can have a first diameter, a second ormiddle portion102bcan have a second diameter, and a third orlower portion102ccan have a third diameter. Themain graft body102 can have any suitable shape, including any of the shapes disclosed elsewhere herein. In some embodiments, as in the illustrated embodiment, thefirst portion102acan have a smaller diameter than thesecond portion102bof themain graft body102. Additionally, thethird portion102ccan have a smaller diameter than thesecond portion102bof themain graft body102. In some embodiments, thethird portion102ccan have the same diameter as compared to thefirst portion102a.Accordingly, to accommodate adjustability of thebranch grafts104,106, thebranch grafts104,106 can be supported by the second orenlarged portion102bof themain graft body102.
• Thefirst portion102acan have any suitable first diameter for the size of the target vessel. Additionally, as mentioned, thesecond portion102bcan have an enlarged diameter within any of the ranges described above. For example, without limitation, theendoluminal prosthesis100 can be configured for deployment in a 26 mm target vessel, wherein thefirst portion102acan have an approximately 28 mm diameter, thesecond portion102bcan have an approximately 34 mm diameter so as to allow for the adjustability of thefenestrations104,106, and thethird portion102ccan have an approximately 28 mm diameter.
• In some embodiments, thebranch grafts104,106 can be integrally formed with themain graft body12. Alternatively, thebranch graft portions104,106 can be formed separately and later attached, adhered, sutured, or otherwise fastened or supported by themain graft body102.
• FIG. 11 is a side view of another embodiment of anendoluminal prosthesis110. As with any of the embodiments of the endoluminal prostheses disclosed herein, any of the features of theendoluminal prosthesis110 can be combined with any of the features of any other embodiment or combination of embodiments of the endoluminal prostheses disclosed herein. Additionally,endoluminal prosthesis110 can have any of the features, components, or other details of any of the other embodiments of the endoluminal prostheses disclosed (directly or by incorporation by reference) herein. As illustrated inFIG. 11, theendoluminal prosthesis110 can have amain graft body112,fenestrations114,116 formed in themain graft body112, and an opening orcutout118 formed in the distal end portion of themain graft body112 to accommodate blood flow to the SMA or otherwise. In some embodiments, branch grafts can be positioned within thefenestrations114,116, or can be sewn, adhered, or otherwise attached to themain graft body112 adjacent to thefenestrations114,116.
• In some embodiments, themain graft body112 can have threeportions112a,112b,112cof varying diameters. However, in some embodiments, the diameter of the threeportions112a,112b,112cof themain graft body112 can be approximately the same. As illustrated inFIG. 11, thefirst portion112acan have any diameter suitable for the size of the target vessel. Additionally, thesecond portion112bcan have an enlarged diameter within any of the ranges described above with respect to themain graft body22. For example, without limitation, theendoluminal prosthesis110 can be configured for deployment in a 26 mm target vessel, wherein thefirst portion112acan have an approximately 28 mm or any other suitable diameter, and thesecond portion112bcan have an approximately 34 mm or any other suitable enlarged diameter so as to allow for the adjustability of thefenestrations114,116. The diameter of thethird portion112ccan be similar to the diameter of thefirst portion112a,or can be any suitable diameter.
• Additionally, in some embodiments, themain graft body112 be sized and configured so as to have excess length ormaterial120 in the graft material. For example, as illustrated inFIG. 11, themain graft body112 can be sized and configured so as to haveexcess material120 below the enlargedsecond portion112b.In some embodiments, themain graft body112 can be configured so that theexcess material120 is positioned above the enlargedsecond portion112b,or so thatexcess material120 is positioned both above and below the enlargedsecond portion112bto allow for greater axial and/or radial adjustability of thefenestrations114,116. The excess material positioned above and/or below the enlarged portion or, if no enlarged portion, above and/or below the fenestrated portion, can permit a greater amount of adjustability of the fenestrations or branch grafts. Any of the embodiments of grafts disclosed herein can have excess material positioned above and/or below the enlarged or fenestrated portion of the graft, or at any suitable position on the graft to increase the adjustability of the fenestrations or branch grafts.
• In some embodiments, theexcess material120 can be approximately 20% of the unstretched length of themain graft body112. In some embodiments, theexcess material120 can be from approximately 10% or less to approximately 30% or more of the unstretched length of themain graft body112. For example, in some embodiments, the total excess length of the graft can be approximately 2 cm. In some embodiments, the total excess length of the graft can be between approximately 1 cm and approximately 3 cm such that amain graft body112 having an unstretched length of approximately 10 cm can have from approximately 11 cm or less to approximately 13 cm or more of graft material positioned thereon.
• In some embodiments, theendoluminal prosthesis110 can have a supra visceral stent orstent segment122 deployed within the first ordistal end portion112aof themain graft body112, astent segment124 deployed within the third orproximal end portion112cof themain graft body112, and one or moreaxial springs126 extending between the suprarenal stent segment122 and thestent segment124. In some embodiments, thesprings126 can be substantially rigid so as to axially position thestent segment122 at a fixed position relative to thestent segment124. Thesprings126 can be attached to thestent segments124,126 at connection points128.
• Theendoluminal prosthesis110 can be configured such that themain graft body112 is secured to thestent segments122,124 only at the end portions of themain graft body112. In some embodiments, theendoluminal prosthesis110 can be configured such that themain graft body112 is secured to thestent segments122,124 at the end portions of themain graft body112 and also at one or more intermediate positions, such as at positions adjacent to one or more of the connection points128.
• In some embodiments (not illustrated), theendoluminal prosthesis110 can be configured to be a bifurcated prosthesis, having one or more branch portions extending below thestent124. In such embodiments, themain graft body112 can extend below thestent124 so as to comprise the branch graft portions. Alternatively, bifurcation branch graft portions can be formed separately and stitched or otherwise attached to themain graft body112. Further, in some embodiments, bifurcation branch stents can be pre-positioned within or otherwise deployed within the branch grafts.
• FIG. 12 is a side view of another embodiment of anendoluminal prosthesis140.FIG. 12A is an enlarged side view of the embodiment of theendoluminal prosthesis140 defined bycurve12A-12A inFIG. 12. As with any of the embodiments of the endoluminal prostheses disclosed (directly or by incorporation by reference) herein, any of the features of theendoluminal prosthesis140 can be combined with any of the features of any other embodiment or combination of embodiments of the endoluminal prostheses disclosed (directly or by incorporation by reference) herein. As such,endoluminal prosthesis140 can have any of the features, components, or other details of any of the other embodiments of the endoluminal prostheses disclosed herein. As illustrated inFIG. 12, theendoluminal prosthesis140 can have amain graft body142,fenestrations144,146 formed in themain graft body142, and an opening orcutout148 formed in the distal end portion of themain graft body142 to accommodate blood flow to the SMA or otherwise. In some embodiments, branch grafts can be positioned within thefenestrations144,146, or can be sewn, adhered, or otherwise attached to themain graft body112 adjacent to thefenestrations144,146.
• In some embodiments, the diameter of thefenestrations144,146 or any other fenestrations disclosed herein can be from approximately 1 mm to approximately 10 mm or more, or from approximately 3 mm to approximately 8 mm, or from approximately 4 mm to approximately 6 mm. Thefenestrations144,146 can be positioned at any desired or suitable axial or radial position in themain graft body142 based on a patient's anatomy. In some embodiments, as illustrated inFIG. 12, thefenestrations144,146 can be circumscribed with a supportive graft material150 (also referred to herein as a fenestration border) to increase the strength of the graft material adjacent to thefenestrations144,146. In some embodiments, thefenestration border150 can increase the strength of the graft material adjacent to thefenestrations144,146 so that thefenestrations144,146 can withstand expansion pressures of up to approximately 15 atm or more.
• In some embodiments, thefenestration border150 can be a generally cylindrically shaped tube of graft material such as PTFE, ePTFE, or any other suitable material that is formed around the fenestration. For example, with reference toFIGS. 12 and 12A, the tube of graft material can be slit longitudinally along the length thereof and positioned over the edge of thefenestrations144,146. Thefenestration border150 can be bonded, sutured, or otherwise attached to or supported by themain graft body142 adjacent to thefenestrations144,146. In some embodiments, thefenestration border150 can be a ring of polyurethane or urethane that can be bonded, sutured, or otherwise attached to or supported by themain graft body142 adjacent to thefenestrations144,146. The polyurethane or urethane can allow for radial expansion of the fenestration by a balloon expander or other suitable expander. In some embodiments, the polyurethane or urethane rings (or rings made from any other suitable material) can be positioned between two or more sheets or layers of graft material (such as, but not limited to, ePTFE) having the polyurethane or urethane bonded thereto. The sheets or layers can be positioned relative to one another with the polyurethane or urethane surfaces facing each other so that the polyurethane or urethane is sandwiched between the sheets or layers of the graft material.
• In some embodiments, as in the illustrated embodiment, a radiopaque material (that can be non-rigid or spring-like) can be embedded in or supported within thefenestration border150. The radiopaque marker can be formed from platinum iridium, which can be in the form of a spring, or any other suitable metallic material known to the industry.
• FIG. 13 is a side view of another embodiment of anendoluminal prosthesis170.FIG. 14 is a top view of the embodiment of theendoluminal prosthesis170 shown inFIG. 13. The embodiment of theendoluminal prosthesis170 illustrated inFIGS. 13 and 14 can have a main graft body172, afirst fenestration174, and asecond fenestration176. In some embodiments, as in the illustrated embodiment, the main graft body172 can be bifurcated, having a firstbifurcated branch178 and a secondbifurcated branch180 for placement in the ipsilateral and contralateral iliac arteries and alumen182 through the main graft body172 in communication with the openings in the first and secondbifurcated branches178,180. Additionally, in some embodiments, theendoluminal prosthesis170 can have any of the components, features, dimensions, materials, or other details of any of the other embodiments of endoluminal prostheses disclosed or incorporated by reference herein, or any other suitable features of endoluminal prostheses known in the field.
• Theendoluminal prosthesis170 can be formed from any suitable material, such as, but not limited to, ePTFE. In some embodiments, theendoluminal prosthesis170 can be formed from an expandable material. Theendoluminal prosthesis170 can be formed such that at least a portion of the main graft body172 can be significantly larger than the target vessel into which the main graft body172 is to be deployed. With reference toFIG. 13, theendoluminal prosthesis170 can be bifurcated and can be deployed so as to span across an aneurysm in the abdominal aortic. In some embodiments, at least a portion of the main graft body172 can have a diameter that can be approximately 30% larger than the diameter of the target vessel. In some embodiments, at least a portion of the main graft body172 can have a diameter that can be from approximately 20% or less to approximately 50% or more, or from approximately 25% to approximately 40% larger than the target vessel, or to or from any values within these ranges.
• As one non-limiting example, the main graft body172 configured for placement in an approximately 28 mm vessel can have at least a portion thereof that has a diameter of approximately 34 mm. Therefore, in some embodiments, the diameter of at least a portion of the main graft body172 can be approximately 8 mm larger than the diameter of the target vessel. In some embodiments, the diameter of at least a portion of the main graft body172 can be between approximately 2 mm and approximately 14 mm, or between approximately 4 mm and approximately 12 mm, or between approximately 6 mm and approximately 10 mm larger than the diameter of the target vessel, or to or from any values within these ranges.
• For example, with reference toFIG. 13, the main graft body172 can have afirst portion172a,a second ormiddle portion172b,and a third orlower portion172c.In some embodiments, thefirst portion172acan have a generally cylindrical shape defined by a first diameter. In some embodiments, thesecond portion172bcan have a generally spherical shape defined by a second, enlarged diameter. Thethird portion172ccan have a generally cylindrical shape defined by a third diameter. The third diameter can be approximately the same as the first diameter, or can be larger or smaller than the first diameter. In some embodiments, thesecond portion172bcan have approximately the same cross-sectional diameter as compared to thefirst portion172a,thesecond portion172bhaving corrugations184 formed therein, as described below, to allow for the adjustability of thefenestrations174,176 or branch grafts (not illustrated).
• As discussed above, the oversized diameter of the main graft body172 can provide excess or slack graft material in the main graft body172 such that thefenestrations174,176 can each be moved in an axial or angular direction to align thefenestrations174,176 with the branch vessels arteries. In some embodiments, branch grafts (not illustrated) can be integrally formed with the main graft body172, or can be formed separately and later attached, adhered, sutured, or otherwise fastened or supported by the main graft body172.
• As described above, two or more fenestrations174,176 can be formed in the main graft body172 at any desired location. With reference toFIG. 13, the twofenestrations174,176 can be formed at generally diametrically opposed locations. However, any number of fenestrations can be formed in the main graft body172 at any desired locations. Additionally, scallops or cutouts can be formed in the distal end portion or at any suitable location in the main graft body172, the scallops or cutouts being configured to prevent obstruction of other arteries branching off of the main vessel into which the main graft body172 is to be deployed. For example, in some embodiments, an additional fenestration can be formed in a distal portion of the main graft body172 so as to align with a patient's SMA.
• In some embodiments, as in the illustrated embodiment, thefenestrations174,176 can be formed in thesecond portion172bof the main graft body172. In some embodiments, the surface of thesecond portion172bof the main graft body172 can have waves, undulations, folds, corrugations, or other similar features184 (collectively referred to as corrugations) pre-formed therein. Thecorrugations184 can be formed in an axial direction, as illustrated inFIGS. 13 and 14, or can be formed in a lateral direction or at any other suitable angular orientation. Additionally, thecorrugations184 can have a linear shape, as illustrated, or can have a curved or any other suitable shape, such as is illustrated inFIGS. 15 and 16.
• FIG. 15 is a side view of another embodiment of anendoluminal prosthesis190, andFIG. 16 is an enlargement of a portion of the embodiment of anendoluminal prosthesis190 shown inFIG. 15, defined by curve16-16, illustrating the adjustability of a branch graft. With reference toFIGS. 15 and 16, the embodiment of theendoluminal prosthesis190 illustrated therein can have amain graft body192, afirst branch graft194, and asecond branch graft196. In some embodiments, as in the illustrated embodiment, themain graft body192 can be bifurcated, having a firstbifurcated branch198 and a secondbifurcated branch200 for placement in the ipsilateral and contralateral iliac arteries and alumen202 through themain graft body192 in communication with the openings in the first and secondbifurcated branches198,180.
• Additionally, in some embodiments, theendoluminal prosthesis190 can have any of the components, features, dimensions, materials, or other details of any of the other embodiments of endoluminal prostheses disclosed or incorporated by reference herein, or any other suitable features of endoluminal prostheses known in the field. For example, without limitation, in some embodiments, themain graft body192 can be formed without thebranch grafts194,196 so that fenestrations are to be aligned with the branch vessels. Further, any suitable number of branch grafts or fenestrations can be formed on themain graft body192.
• With reference toFIGS. 15 and 16, thecorrugations204 formed in themain graft body192 can be curved. In some embodiments, thecorrugations204 can be generally curved in shape and can be formed about the axial centerline of each of thebranch grafts194,196. With reference toFIG. 15, line L1 represents the axial centerline of each of thebranch grafts194,196 when thebranch grafts194,196 are in a relaxed state. In some embodiments, thecorrugations204 can define a generally circular shape. As described with respect toendoluminal prosthesis170 described above, thecorrugations204 can be configured to allow thebranch grafts194,196 to move in an axial or angular direction to align thebranch grafts194,196 with the branch vessels arteries.
• As mentioned,FIG. 16 is an enlargement of a portion of theendoluminal prosthesis190 shown inFIG. 15, illustrating the adjustability of abranch graft196. For example, thebranch graft196 can be adjusted from the position defined by line L1 (which represents the axial centerline of thebranch graft196 in the relaxed state) to the position defined by line L2 (which represents the axial centerline of thebranch graft196 in the adjusted state). As the branch graft is adjusted from the positioned defined by line L1 to the position defined by line L2, the portions of thecorrugations204aabove the line L2 gather or become closer together, while the portions of thecorrugations204bbelow the line L2 stretch or move further apart from one another, thus allowing thebranch graft196 to be adjusted upwardly without deforming or stretching other portions of themain graft body192. Lines L1 and L2 are meant to describe the adjustment of thebranch grafts194,196 in any suitable axial or angular direction and are not meant to be limited by the example or examples provided herein. Further, lines L1 and L2 need not be parallel lines, since angular orientation of thebranch grafts194,196 relative to themain graft body192 can be adjustable also.
• In the illustrated embodiment, thebranch grafts194,196 can be approximately aligned so that the axial centerline of thebranch graft194 is approximately collinear with the axial centerline of thebranch graft196. In some embodiments, thebranch grafts194,196 can be positioned on themain graft body192 so that the axial centerline of thebranch graft194 is not aligned or collinear with the axial centerline of thebranch graft196.
• In some of the embodiments disclosed herein, one or more stents can be pre-positioned within the branch grafts before the endoluminal prosthesis has been deployed in the target location. For example, in some embodiments, the one or more stents can be balloon expandable, self-expandable, or other suitable stents that can be positioned within the branch grafts before the endoluminal prosthesis is loaded into a delivery catheter. For example, with reference toFIG. 17, which is a side view of another embodiment of anendoluminal prosthesis300, theendoluminal prosthesis300 can have amain graft body302 andbranch grafts304,306 supported by themain graft body302. In some embodiments, an additional fenestration can be formed in themain graft body302 to accommodate blood flow to the SMA or otherwise. Alternatively, a branch graft (not illustrated) can be supported by themain graft body302 to accommodate the blood flow to the SMA
• Theendoluminal prosthesis300 illustrated inFIG. 17 can have any of the same features as compared to the embodiment of theendoluminal prosthesis100 illustrated inFIG. 10 and described above or any of the embodiments of the endoluminal prostheses disclosed (directly or by incorporation by reference) herein. As with theendoluminal prosthesis100 illustrated inFIG. 10 above, to accommodate positional adjustability of thebranch grafts304,306, thebranch grafts304,306 can be supported by the second or enlarged portion302bof themain graft body302.
• In some embodiments, thebranch grafts304,306 can be integrally formed with themain graft body302. Alternatively, thebranch graft portions304,306 can be formed separately and later attached, adhered, sutured, or otherwise fastened or supported by themain graft body302. Additionally, before theendoluminal prostheses300 is loaded into a delivery catheter, first andsecond guidewires310,312 can be advanced through thebranch grafts304,306, respectively. In some embodiments, theguidewires310,312 can be hollow so that they can be passed or advanced over guidewires that are pre-wired in the patient's vasculature to guide theendoluminal prostheses300 to the target location. Advancing theguidewires310,312 over the pre-wired guidewires can also facilitate the alignment of each of thebranch grafts304,306 with each of the branch vessels in the patient's vasculature.
• In some embodiments, theguidewires310,312 can be made from a plastic extrusion or metal braids. For example, in some embodiments, thehollow guidewires310,312 can be made from braided Nitinol wire. In some embodiments, the outer diameter of theguidewires310,312 can be approximately 0.035 in and the lumen of the guidewire can be approximately 0.016 in to accommodate a second 0.014 in guidewire. In some embodiments, theguidewires310,312 can be configured to pass over a 0.018 in or any other suitable guidewire. As mentioned above, in some embodiments, theguidewires310,312 can support balloons on the distal ends of theguidewires310,312. The balloons can be inflated in the branch vessel to deploy expandable stents within thebranch grafts304,306.
• Additionally, as illustrated inFIG. 17,stents314,316 can be positioned within each of thebranch grafts304,306, respectively, before theendoluminal prosthesis300 is loaded into the delivery catheter. In some embodiments, each of thestents314,316 can be a bare metal stent or a covered stent (i.e., covered with a tubular shaped graft material). Additionally, in some embodiments, thestents314,316 can be self expanding or can be balloon expandable. In the illustrated embodiment, each of thestents314,316 can be supported by anexpansion balloon318,320, respectively, positioned within each of thebranch grafts304,306. Accordingly, each of theguidewires310,312 can be configured to allow for the inflation and expansion of the expansion balloons318,320. For example, theguidewires310,312 can have a first lumen that can be advanced over a pre-wired guidewire and a second inflation lumen configured to communicate a positive pressure to each of the expansion balloons318,320.
• In some embodiments, theendoluminal prostheses300 can be loaded into a delivery catheter so that each of theguidewires310,312 protrudes out from the inside of an outer sleeve of the delivery catheter so that each of theguidewires310,312 can be advanced over the pre-wired guidewires positioned within the patient's vasculature. Thus, during deployment, in some embodiments, each of thestents314,316 can be expanded and hence deployed within each of thebranch grafts304,306 after each of thebranch grafts304,306 has been aligned and positioned within the respective branch vessels. In some embodiments, each of thestents314,316 can be expanded and hence deployed within each of thebranch grafts304,306 before themain graft body302 has been secured in the main target vessel.
• In some embodiments, thestents314,316 and the expansion balloons318,320 can be supported within thebranch grafts304,306, respectively, so that thestents314,316 and the expansion balloons318,320 are axially secured to each of thebranch grafts304,306. In this arrangement, advancing theguidewires310,312 and, accordingly, thestents314,316 and the expansion balloons318,320, into the respective branch vessels after theendoluminal prosthesis300 has been at least partially released from the deployment catheter, can allow thebranch grafts304,306 to be aligned with and advanced into the target branch vessels.
• Additionally, in some embodiments, covered or uncovered stents can be pre-positioned in the main graft body of a fenestrated endoluminal prosthesis so as to be partially advanced through each of the fenestrations before the endoluminal prosthesis is loaded into the delivery catheter. The stents can be secured to or otherwise configured to engage each of the fenestrations such that, as the stents are advanced along the pre-wired guidewires into the respective branch vessels, the fenestrations can be aligned with the respective branch vessels. In some embodiments, the stents can have flanged portions or be partially expanded so as to engage the fenestrations such that advancing the stents into the respective branch vessels can align the fenestrations with the respective branch vessels. Additionally, in some embodiments, the guidewires themselves can be configured to engage each of the fenestrations such that, as the deployment guidewires are advanced along the pre-wired guidewires into the respective branch vessels, the fenestrations can be aligned with the respective branch vessels without the use of stents for alignment.
• However, the pre-positioning of thestents314,316 and theballoons318,320 in theendoluminal prostheses300 described above is not required. In some embodiments, one or more stents can be advanced through the patient's vasculature and into thebranch grafts304,306 after theendoluminal prostheses300 has been positioned within the target vessel in the patient's vasculature. For example, one or more stents can be advanced through the patient's vasculature into thebranch grafts304,306 after thebranch grafts304,306 have been positioned within the target branch vessels and after themain graft body302 has been secured within the main target vessel.
• Additionally, any of the features, components, or details of any of the graft, stents, or other apparatuses disclosed in U.S. patent application Ser. No. 12/496,446, filed on Jul. 1, 2009, entitled CATHETER SYSTEM AND METHODS OF USING SAME, U.S. patent application Ser. No. 12/390,346, filed on Feb. 20, 2009, entitled DESIGN AND METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM, and U.S. patent application Ser. No. 12/101,863, filed on Apr. 11, 2008, entitled BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS can be used, with or without modification, in place of or in combination with any of the features or details of any of the grafts, stents, prostheses, or other components or apparatuses disclosed herein. Similarly, any of the features, components, or details of the delivery apparatuses and deployment methods disclosed in U.S. patent application Ser. Nos. 12/496,446, 12/390,346, and 12/101,863, can be used, with or without modification, to deploy any of grafts, stents, or other apparatuses disclosed herein, or in combination with any of the components or features of the deployment systems disclosed herein. The complete disclosures of U.S. patent application Ser. Nos. 12/496,446, 12/390,346, and 12/101,863 are hereby incorporated by reference as if set forth fully herein.
• FIG. 18 is a side view of theendoluminal prosthesis300 withguidewires310,312 advanced through each of thebranch grafts304,306, showing theendoluminal prostheses300 being loaded within adelivery catheter330. Theouter sheath332 illustrated inFIG. 18 is sectioned for clarity. With reference toFIG. 18, thecollapsed endoluminal prosthesis300 can be supported within theouter sheath332 of thedelivery catheter330 in the space between thecatheter shaft334 and thecatheter tip336. In some embodiments, thehollow guidewires310,312 can slide through openings or lumens in thecatheter shaft86. Alternatively, in some embodiments, thehollow guidewires310,312 can be fixed to thecatheter shaft334.
• FIG. 19 is a side view of theendoluminal prostheses300 withguidewires310,312 advanced through each of thebranch grafts304,306, showing theendoluminal prostheses300 fully loaded within adelivery catheter330 and being advanced along guidewires pre-wired in the patient's vasculature. Theouter sheath332 illustrated inFIG. 19 is sectioned for clarity. With reference toFIG. 19, as discussed above, thehollow guidewires310,312 can be advanced through thebranch grafts304,306, respectively, of theendoluminal prosthesis300. Theendoluminal prosthesis300 can then be compressed and loaded within thedelivery catheter330, as is illustrated inFIG. 19. For example, in this configuration, theendoluminal prosthesis300 can be retained in thedelivery catheter330 by theouter sheath332. Retraction of theouter sheath332 can deploy theendoluminal prosthesis300. With theouter sheath332 retracted, theendoluminal prosthesis300 can expand either by self-expansion, balloon expansion, or by any other suitable method or mechanism.
• Thehollow guidewires310,312 can pass through theouter sheath332 from the proximal end of the delivery catheter330 (i.e., the end of thedelivery catheter330 located outside of the patient) to the distal end of thedelivery catheter330. Each of thehollow guidewires310,312 can be configured to receive or allow the insertion of a 0.014 in guidewire, a 0.018 in guidewire, a 0.035 in guidewire, or any diameter guidewire therethrough deemed suitable for the design. In this configuration, thehollow guidewires310,312 can pass overguidewires340,342 that can be pre-wired in the target vessels.
• As can be seen inFIGS. 18 and 19, in some embodiments, thecatheter330 can have at least three lumens through at least a portion of thecatheter330. Each of the three lumens can be configured to receive a guidewire. Having three lumens through at least a portion of thecatheter330 can prevent twisting of the guidewires so as to ensure proper deployment of theendoluminal prostheses300 or any other endoluminal prostheses disclosed (directly or by incorporation by reference) herein. Thecatheter330 can be configured to receive thepre-wired guidewire344 through a lumen formed in the approximate center of the catheter. The lumen can pass through thecatheter tip336 and thecatheter shaft334.
• Theguidewires340,342 can each be pre-wired through the patient's vasculature to pass into each of the target branch vessels branching from the target main vessel. Theguidewire344 can be passed through the target main vessel. As described above, once theendoluminal prosthesis300 has been advanced to the target location along theguidewires340,342,344 within the patient's vasculature, retracting theouter sheath332 of thecatheter330 and can cause theendoluminal prosthesis300 to be deployed at the target location such that each of thebranch grafts304,306 can be advanced into each of the branch vessels. After thebranch grafts300,306 are positioned within the target branch vessels, each of thestents304,306 can be expanded in the branch vessels to secure thebranch grafts304,306 in the branch vessels. A stent or other suitable device can be deployed within themain graft body302 to secure themain graft body302 within the main vessel.
• In some embodiments, one or more of thepre-wired guidewires340,342 described above can be configured to be insertable into a branch vessel and to be biased such that an end portion of theguidewire340,342 remains in the branch vessel. During manipulation of the guidewires and/or deployment catheter, it sometimes becomes difficult to maintain the position of the distal portion of the guidewires in the branch vessels. Biasing the end portion of theguidewire340,342 to remain in the branch vessel can thus improve any of the deployment procedures described herein. Additional details regarding such guidewires is set forth below.
• FIG. 20 is a side view of another embodiment of adelivery catheter400 that can be used to deploy at least some of the embodiments of the endoluminal prostheses disclosed herein, showing an embodiment of anendoluminal prosthesis402 being loaded within adelivery catheter400.FIG. 21 is an enlarged partial section view of a portion of the embodiment of adelivery catheter400 illustrated inFIG. 20, showing theendoluminal prostheses402 loaded within adelivery catheter400. As illustrated inFIGS. 20 and 21, theendoluminal prosthesis402 can be similar to theendoluminal prosthesis80 described above, can be a bifurcated endoluminal prosthesis such asendoluminal prosthesis90 described above, or can have any of the features, components, or other details of any of the other endoluminal prostheses disclosed herein, directly or by incorporation by reference. As with the endoluminal prostheses described herein, themain graft body404 can be configured to accommodate positional adjustability of thefenestrations406,408. For example, without limitation, fenestrations406,408 can be formed within an enlarged portion of themain graft body404.
• With reference toFIGS. 20 and 21, theendoluminal prosthesis302 can have amain graft body404 havingfenestrations406,408 formed therein, and one ormore stent segments410,412 deployed within themain graft body404. Thestents410,412 can be bare metal, covered, self-expandable, balloon expandable, or any other suitable stents either disclosed (directly or by incorporation by reference) herein or otherwise known in the art or later developed. As illustrated inFIGS. 20 and 21, first andsecond guidewire sheaths420,422 can be advanced through thefenestrations406,408, respectively, before theendoluminal prosthesis402 is loaded into adelivery catheter400 or otherwise such that the first andsecond guidewire sheaths420,422 are advanced through thefenestrations406,408, respectively, when theendoluminal prostheses402 is in the loaded state in thedelivery catheter400.
• In some embodiments, theguidewire sheaths420,422 can be hollow so that they can be passed or advanced over pre-positioned guidewires that are pre-wired in the patient's vasculature to guide theendoluminal prostheses402 to the target location. Advancing theguidewire sheaths420,422 over the pre-wired guidewires can also facilitate the alignment of each of thefenestrations406,408 with each of the branch vessels in the patient's vasculature.
• In some embodiments, each of theguidewire sheaths420,422 can be made from the same material and have the same features, sizes, or other details of any other guidewire disclosed herein, including withoutlimitation guidewires310,312 described above. Additionally, as withguidewires310,312, in some embodiments, theguidewire sheaths420,422 can support balloons on the distal ends of theguidewire sheaths420,422. The balloons can be inflated in the branch vessel to deploy expandable stents within or adjacent to thefenestrations406,408. In some embodiments (not illustrated), flared, flareable, bare metal, covered, self-expandable, balloon expandable, or any other suitable stents disclosed (directly or by incorporation by reference) herein, known in the field, or later developed can be positioned within each of thefenestrations406,408, respectively, before theendoluminal prosthesis402 is loaded into thedelivery catheter400. The stents can be deployed following any suitable procedure, including without limitation the procedure described above with respect to thestents314,316.
• In this configuration, the branch stents (not illustrated) can be secured to or otherwise configured to engage each of thefenestrations406,408 such that, as the stents are advanced along the pre-wired guidewires into the respective branch vessels, thefenestrations406,408 can be aligned with the respective branch vessels. In some embodiments, as mentioned, the stents can have flanged or flared portions or be partially expanded so as to engage thefenestrations406,408 such that advancing the stents into the respective branch vessels can align thefenestrations406,408 with the respective branch vessels. Additionally, in some embodiments, the guidewires themselves can be configured to engage each of thefenestrations406,408 such that, as thedeployment guidewire sheaths420,422 are advanced along the pre-wired guidewires into the respective branch vessels, thefenestrations406,408 can be aligned with the respective branch vessels without the use of stents for alignment.
• However, the pre-positioning of the stents and the balloons in theendoluminal prostheses402 described above is not required. In some embodiments, one or more stents can be advanced through the patient's vasculature and into thefenestrations406,408 after theendoluminal prostheses402 has been positioned within the target vessel in the patient's vasculature. For example, one or more stents can be advanced through the patient's vasculature into thefenestrations406,408 after themain graft body404 has been positioned within the main target vessel or after thefenestrations406,408 have been positioned adjacent to the target branch vessels.
• With reference toFIGS. 20 and 21, thedelivery catheter400 can have anouter sheath430, adistal tip432 having a lumen oropening434 therethrough, and acentral tube436 that can secure thedistal tip432 to thedelivery catheter400. Theopening434 in thedistal tip432 can extend through thecentral tube436 so that thedelivery catheter400 can be advanced over a pre-positioned guidewire. Theouter sheath430 can be axially moveable relative to thecentral tube436 and thedistal tip432, so that theendoluminal prosthesis402 can be exposed and deployed from thedelivery catheter400 by retracting theouter sheath430 relative to thecentral tube436 and thedistal tip432.
• Thedistal tip432 can be made from a soft material and/or otherwise be configured to be atraumatic to the patient's vasculature so as to minimize injury to the patient's vasculature during advancement of thedelivery catheter400 through the patient's vasculature. In some embodiments, thedistal tip432 can have a substantially circular cross-section along the length thereof, as illustrated inFIG. 22A, which is a section view of an embodiment of adistal tip432, taken throughline22A-22A inFIG. 20. As illustrated, thedistal tip432 can be tapered along a portion of the length thereof.
• In some embodiments, thedistal tip432 can have a cross-section that is generally circular, as illustrated inFIG. 22A. In some embodiments, as illustrated inFIG. 22B, thedistal tip432′ can have a non-circular cross-section.FIG. 22B is a section view of another embodiment of adistal tip432′ that can be used with the embodiment of thedelivery catheter400 that is illustrated inFIG. 20, taken throughline22B-22B inFIG. 20. For example, as illustrated, thedistal tip432′ can have one or more channels438 formed along a portion of the length of thedistal tip432′. The one or more channels438 (two being shown) can each be configured to receive aguidewire sheath420,422 therein. For example, with reference toFIG. 22B, the two channels438 can be configured to releasably receive each of theguidewire sheaths420,422 therein so as to reduce the cross-sectional profile of thedelivery catheter400 and to permit theouter sheath430 to be advanced over thedistal tip432 with the guidewires positioned adjacent to thedistal tip432 and advancing beyond thedistal tip432 without obstruction from theguidewire sheaths420,422. For example, the channels438 can be configured so that theouter sheath430 can be advanced over and fit closely around thedistal tip432.
• FIG. 23A is a section view of the embodiment of thedelivery catheter400 shown inFIG. 20, taken throughline23A-23A inFIG. 20.FIG. 23B is a section view of the embodiment of thedelivery catheter400 shown inFIG. 20, taken throughline23B-23B inFIG. 20.FIGS. 23A and 23B represent different embodiments of thedelivery catheter400. With reference toFIG. 23A, some embodiments of thedelivery catheter400 can have anouter sheath430 that can be advanced through anintroducer sheath444 and aninner core446 that can be axially advanced relative to theouter sheath430. Some embodiments of thedelivery catheter400 can be configured so that theinner core446 can be rotated relative to theouter sheath430, or can be configured so that theinner core446 can be rotationally linked to theouter sheath430. Additionally, theinner core446 can be configured to axially support thecentral tube436 and, hence, thedistal tip432 so that, as theinner core446 is advanced relative to theouter sheath430, thecentral tube436 and thedistal tip432 can be simultaneously advanced relative to theouter sheath430.
• Further, with reference toFIG. 23A, alumen450 can be formed axially through at least a portion of theinner core446, thelumen450 being configured to slideably receive aguidewire452 therein. In some embodiments, thelumen450 can be in communication with theopening434 that can be formed through thedistal tip432 and thecentral tube436 such that theopening434 and thelumen450 can slidingly receive a pre-positioned guidewire as thedelivery catheter400 is advanced over the guidewire. Similarly, alumen454 can be formed through at least a portion of theinner core446 as illustrated inFIG. 23A, thelumen454 being configured to slideably receive a guidewire, release wire, orother wire456 therein.
• In some embodiments, theendoluminal prosthesis402 can be similar to or have any of the features of the endoluminal prostheses disclosed in U.S. patent application Ser. No. 12/101,863, filed on Apr. 11, 2008 (entitled “BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS”), which is hereby incorporated by reference in its entirety as if fully set forth herein. In some embodiments, therelease wire456 can be or can be connected to the sheath release wire166 used to deploy the main branch sheath186 in U.S. patent application Ser. No. 12/101,863.
• Alumen460 having one or more lobes can be formed axially through at least a portion of theinner core446. Thelumen460 can be configured to receive one or more guidewires or guidewire sheaths therein. In the illustrated embodiment, thelumen460 can be configured to receive two guidewire sheaths therein, such as withoutlimitation guidewire sheaths420,422. Additionally, in some embodiments, theguidewire sheaths420,422 each can be configured to receive a guidewire catheter therein, such as withoutlimitation guidewire catheters464,466, respectively, havingguidewires468,470 therein. In some embodiments, theguidewire sheaths420,422 can each be sized and configured to axially receive a renal, covered or bare metal stent therein so that a renal stent can be advanced through theguidewire sheaths420,422 and deployed in the renal branch arteries as described herein. In some embodiments, the renal stents (not illustrated) can be advanced over theguidewire catheters464,466 within theguidewire sheaths420,422.
• In some embodiments, thehollow guidewire sheaths420,422 can slide within thelumen460. Alternatively, in some embodiments, thehollow guidewire sheaths420,422 can be fixed to theinner core446. Theguidewire catheters464,466 can each be configured to receive a pre-positioned guidewire therein, so that theguidewire catheters464,466 can be advanced over pre-positioned guidewires routed into the renal arteries as thedelivery catheter400 is advanced over thepre-positioned guidewire452.
• Similarly, with reference toFIGS. 23B, in some embodiments, thedelivery catheter400 can have anouter sheath430 that can be advanced through anintroducer sheath444 and aninner core446′ that can be axially advanced relative to theouter sheath430. In some embodiments, thedelivery catheter400 can be configured so that theinner core446′ can be rotated relative to theouter sheath430, or can be configured so that theinner core446′ can be rotationally linked to theouter sheath430. Additionally, theinner core446′ can be configured to axially support thecentral tube436 and, hence, thedistal tip432 so that, as theinner core446′ is advanced relative to theouter sheath430, thecentral tube436 and thedistal tip432 can be simultaneously advanced relative to theouter sheath430.
• Further, with reference toFIG. 23B, alumen450 can be formed axially through at least a portion of theinner core446′, thelumen450 being configured to slideably receive aguidewire452 therein. In some embodiments, thelumen450 can be in communication with theopening434 that can be formed through thedistal tip432 and thecentral tube436 such that theopening434 and thelumen450 can slidingly receive a pre-positioned guidewire as thedelivery catheter400 is advanced over the guidewire. Similarly, alumen454 can be formed through at least a portion of theinner core446′ as illustrated inFIG. 23B, thelumen454 being configured to slideably receive a guidewire, release wire, orother wire456 therein.
• In some embodiments, one ormore channels460′ can be formed axially on at least a portion of theinner core446′. Thechannels460′ can each be configured to receive one or more guidewires or guidewire sheaths therein. In the illustrated embodiment, thechannels460′ can be configured to receive two guidewire sheaths therein, such as withoutlimitation guidewire sheaths420,422, configured as described above. Theguidewire catheters464,466 can each be configured to receive a pre-positioned guidewire therein, so that theguidewire catheters464,466 can be advanced over pre-positioned guidewires routed into the renal arteries as thedelivery catheter400 is advanced over thepre-positioned guidewire452.
• With reference toFIGS. 24-28, some non-limiting examples of delivery methods for delivering some embodiments of the endoluminal prostheses disclosed herein to the abdominal aortic region will be described.FIG. 24 is a side view of an embodiment of a delivery catheter, such as withoutlimitation delivery catheter400 described above, showing adelivery catheter400 being advanced distally past abifurcated prosthesis480 and showingguidewire sheaths420,422 being advanced into the renal arteries.
• With reference toFIG. 24, after thebifurcated prosthesis480 has been deployed in the abdominal aorta following any suitable methods for such deployment, including without limitation the deployment methods disclosed in U.S. patent application Ser. No. 12/390,346 or U.S. patent application Ser. No. 12/101,863, thedelivery catheter400 can then be advanced through the main body of thebifurcated prosthesis480 into the abdominal aorta and renal artery region.
• In some embodiments, theguidewire sheaths420,422 can be advanced along pre-positioned guidewires into the renal arteries. In some embodiments, as illustrated inFIG. 24, theouter sheath430 can be partially retracted so that theguidewire sheaths420,422 can be advanced into the renal arteries as thedistal tip432 of thedelivery catheter400 is advanced past the renal arteries alongguidewire452. Thereafter, the pre-placement guidewires (if any) positioned within theguidewire sheaths420,422 and already advanced into the renal arteries can be removed.
• As illustrated inFIG. 25, which is a side view of the embodiment of thedelivery catheter400 shown inFIG. 24,biased guidewires482,484, which will be described in greater detail below, can be advanced through theguidewire sheaths420,422 and into the renal arteries. As will be described, the coileddistal end portions482a,484aof each of thebiased guidewires482,484 can be configured to be insertable into a branch vessel and can be biased to remain in the branch vessel.
• FIG. 26 is a side view of the embodiment of thedelivery catheter400 shown inFIG. 24, showing the embodiment of theendoluminal prosthesis402 being deployed within the target vessel region. In some embodiments, theendoluminal prosthesis402 can be a fenestrated cuff. Theendoluminal prosthesis402 can be deployed by any suitable method, such as without limitation removing a restraining sheath or by any of the methods disclosed in U.S. patent application Ser. No. 12/390,346 or U.S. patent application Ser. No. 12/101,863, each of which are hereby incorporated by reference as if fully set forth herein.
• For example, without limitation, theendoluminal prosthesis402 can be deployed by removing a perforated sheath using a sheath release wire threaded through perforations in the sheath, such as is set forth in some embodiments of U.S. patent application Ser. No. 12/101,863, which application is fully incorporated herein by reference. Additionally, in some embodiments, the proximal end portion of theendoluminal prosthesis402 can be deployed by distally advancing a sheath or other restraint so as to deploy the proximal end of the endoluminal prosthesis402 (i.e., the end of theendoluminal prosthesis402 that is furthest advanced into the vasculature or closest to the heart).
• The proximal end of theendoluminal prosthesis402 can be deployed proximal to the desired visceral vessel (such as, without limitation, the SMA) and then axially retracted until the proximal portion of theendoluminal prosthesis402 is positioned just below the target visceral vessel (e.g., without limitation, the SMA). Theadjustable fenestrations406,408 can then be adjusted to be positioned adjacent to the respective renal arteries. Thereafter, the distal portion of the endoluminal prosthesis402 (i.e., the portion of theendoluminal prosthesis402 furthest away from the heart) can be deployed within thebifurcated prosthesis480 by retracting theouter sheath430, as is illustrated inFIG. 27.FIG. 27 is a side view of the embodiment of thedelivery catheter400 shown inFIG. 24, showing theendoluminal prosthesis402 after the distal portion of theendoluminal prosthesis402 has been deployed within thebifurcated prosthesis480.
• As further illustrated inFIG. 27, theinner core446,distal tip432, andcentral tube436 can be axially retracted through theouter sheath430 and removed from the target vessel region, leaving theguidewire sheaths420,422 positioned within the patient's renal arteries. In some embodiments, thedelivery catheter400 illustrated inFIG. 23B can be configured such that theinner core446,distal tip432, andcentral tube436 can be axially retracted through theouter sheath430 while leaving theguidewire sheaths420,422 positioned within the renal arteries. Thereafter, any suitable renal stents (such, as without limitation,stents314,316 described above) can be advanced through theguidewire sheaths420,422 and deployed within the renal arteries over thebiased guidewires482,484 or other guidewires in the renal arteries. In some embodiments, with reference toFIG. 28, renal stents (such as withoutlimitation stents314,316) can be advanced through theguidewire sheaths420,422 and deployed within the renal arteries over thebiased guidewires482,484 or any other guidewires without removing theinner core446,distal tip432, andcentral tube436.
• FIG. 29 is a side view of another embodiment of adelivery catheter500 showing adelivery catheter500 being advanced distally past branch arteries in the thoracic aorta region of a patient's vasculature.FIG. 30 is a side view of anendoluminal prosthesis502 that can be deployed using the embodiment of thedelivery catheter500 shown inFIG. 29. In some embodiments, theendoluminal prosthesis502 can have amain graft body504 havingmultiple fenestrations506,508,510 formed therein. Thedelivery catheter500 can have anouter sheath514 and adistal tip516 configured to be advanced over aguidewire518, as with the other embodiments of the delivery catheters disclosed herein.
• Theendoluminal prosthesis502 anddelivery catheter500 can have any of the components, features, or other details of any of the other endoluminal prostheses or delivery catheters disclosed (directly or by incorporation by reference) herein. For example, in some embodiments, theendoluminal prosthesis502 can have stents or stent segments deployed within themain graft body504, springs, or other suitable structures deployed or supported within themain graft body504. Additionally, in some embodiments, themain graft body504 can have an enlarged diameter along at least a portion of themain graft body504 and/or an additional graft material or length along at least a portion of themain graft body504 to improve the adjustability of thefenestrations506,508,510.
• In some embodiments, thedelivery catheter500 and theendoluminal prosthesis502 can be configured such that a guidewire sheath (such as without limitation guidewire sheaths420) can be pre-positioned within thedelivery catheter500 and theendoluminal prosthesis502, the guidewire sheaths (not illustrated inFIGS. 29,30) advancing through each of thefenestrations506,508,510. Thedistal tip516 of the delivery catheter can be configured to have channels formed therein configured to receive the guidewire sheaths, similar to thedistal tip432′ disclosed herein.
• In some embodiments, the branch arteries can be pre-wired withguidewires520,522,524 (which can be biased guidewires), similar to any of the pre-wiring techniques for the renal arteries disclosed herein, so that thedelivery catheter500 and theendoluminal prosthesis502 having guidewire sheaths positioned therein can be advanced over theguidewires520,522,524 to approximately align thefenestrations506,508,510 as theendoluminal prosthesis502 is being advanced into the target vessel region. Additionally, in some embodiments, the guidewire sheaths can be advanced into the branch arteries as theendoluminal prosthesis502 is being deployed, similar to the deployment of the aortic grafts disclosed herein. Thereafter, any suitable branch stents (such as withoutlimitation stents314,316) can be advanced through the guidewire sheaths (not illustrated) and deployed within the branch arteries over theguidewires520,522,524.
• FIG. 31 is a section view of an embodiment of aguidewire700, showing theguidewire700 in the open or collapsed configuration.FIG. 32 is a section view of the embodiment of theguidewire700 shown inFIG. 31, showing theguidewire700 in the closed or expanded configuration. In some embodiments, without limitation, theguidewire700 can be used in place of either of theguidewires340,342 shown inFIG. 19 and described above. Any of the guidewires disclosed herein can comprise a shape memory material, such as without limitation Nitinol.
• In some embodiments, theguidewire700 can have anouter guidewire sheath702 having anexpandable portion704. Additionally, theguidewire700 can have aninner guidewire core706 slidably received within a lumen formed within theouter guidewire sheath702. In some embodiments, theouter guidewire sheath702 can be sized and configured such that theguidewires310,312 described above or any other guidewires or lumens can be advanced over the outside of theouter guidewire sheath702, as described above.
• With reference toFIG. 31, theexpandable portion704 can be configured such that, when theexpandable portion704 is axially collapsed, the diameter of theexpandable portion704 can increase and be configured such that, when theexpandable portion704 is axially extended, the diameter of theexpandable portion704 can decrease. For example, with reference toFIG. 31, as theinner guidewire core706 is advanced relative to theouter guidewire sheath702 in the direction represented by arrow A1 inFIG. 31, theexpandable portion704 can be axially extended, thus reducing the diameter of theexpandable portion704. In contrast, with reference toFIG. 32, as theinner guidewire core706 is retracted relative to theouter guidewire sheath702 in the direction represented by arrow A2 inFIG. 32, the collapsible portion can be axially compressed, thus increasing the diameter of theexpandable portion704. In some embodiments, theexpandable portion704 can have a bellows type, undulating, or corrugated outer surface.
• In this arrangement, theguidewire700 can be advanced through the patient's vasculature to the target branch vessel while theguidewire700 is in the collapsed configuration (i.e., the configuration shown inFIG. 31). When the distal end portion of theguidewire700 has reached the desired position within the branch vessel, theinner guidewire core706 can then be retracted relative to the outer guidewire sheath702 (i.e., retracted in direction A2 relative to the outer guidewire sheath702) so that the diameter of theexpandable portion704 can be increased and expand radially against the inner surface of the branch vessel wall. In this arrangement, theexpandable portion704 can secure the distal end portion of theguidewire700 in the desired branch vessel. Theexpandable portion704 can be formed from a soft, atraumatic material to minimize the risk of any injury to the vessel wall.
• FIGS. 33 and 34 each illustrate a pair ofguidewires700 positioned within the patient's vasculature such that the distal end portions of theguidewires700 can be secured at least partially within the patient's branch vessels. In some embodiments, theguidewires700 can be positioned within the patient's vasculature such that a portion of theexpandable portion704 protrudes into the lumen of the main vessel, which a portion of theexpandable portion704 protrudes into the branch vessel. InFIG. 34, the distal end portion of theguidewires700 have been advanced further as compared to theguidewires700 shown inFIG. 33, to allow additional space for the deployment of branch grafts within the branch vessels. Theexpandable portion704 can be formed from metal, plastic, or any other suitable material, and can have an expandable bellows configuration or can be formed from one or more braids of wire. Additionally, in some embodiments, theexpandable portion704 can be used to align the fenestrations or branch grafts with the branch vessels.
• Once theguidewires700 have been secured in the desired branch vessels, any of the deployment catheters described above can then be advanced over theguidewires700. When the graft deployment procedure is complete and theguidewires700 are no longer needed in the branch vessels, theguidewire core706 can then be retracted relative to theouter sheath702 of theguidewires700 so that theguidewires700 can be removed from the patient's vasculature. Alternatively, other securing mechanisms can be attached to the distal end portion of the guidewire, such as, without limitation, hooks, barbs, or other similar features, to removably secure one or more of theguidewires700 within the vessel.
• For example, in some embodiments, one of more of the guidewires disclosed herein (such as, without limitation, guidewires700) can have a coiled distal end portion. The coiled distal end portion can be configured to be insertable into a branch vessel and can be biased to remain in the branch vessel. For example, in some embodiments, the size or diameter of the coils can be greater than the inside diameter of the branch vessel so as to bias the coiled portion to remain within the branch vessel when the proximal end of the guidewire is retracted. In this configuration, proximal retraction of the guidewire can cause a proximal end of the coil to unravel, allowing a portion of the coiled portion of the guidewire to be unraveled and retracted while the remaining portion of the coiled portion can remain within the branch vessel. This configuration can inhibit the distal end portion of the guidewire from being inadvertently removed from the branch vessel. To completely remove the coiled distal end portion from the branch vessel, the guidewire can be retracted until the entire coiled portion is unraveled and retracted. In some embodiments (not illustrated), theinner guidewire core706 of theguidewire700 can be configured such that, when the distal end of theinner guidewire core706 is advanced beyond the distal end of theouter guidewire sheath702, the distal end of theinner guidewire core706 forms its coils that expand against the inner vessel wall and secure theguidewire700 to the branch vessel.
• FIG. 35 is a side view of another embodiment of anexpandable guidewire720, showing theguidewire720 in an expanded configuration. Theguidewire720 can have expansion struts722 that can expand when deployed in the renal or other branch arteries. In some embodiments, theguidewire720 can be formed from a tube of Nitinol that can be perforated or cut so as to form a plurality of axial members or struts722, and heat set so that the expansion struts722 form a size that is larger than the desired vessel diameter. In some embodiments, the guidewire can have four or less, or six, or eight or more struts722.
• In some embodiments, theguidewire720 can be advanced through a tubular guidewire sheath that terminates in the desired branch vessel location. As the expansion struts722 exit the distal end of the tubular guidewire sheath, the expansion struts722 can self-expand against the walls of the target vessel so as to bias theguidewire720 in the desired location. Alternatively, a two-way guidewire (i.e., one having sufficient compressive and tensile strength) can be advanced through thehollow guidewire720 so as to elongate and, hence, radially collapse the expansion struts722. In some embodiments, theguidewire722 can have acoiled end portion724 to be more atraumatic.
• FIG. 36 is a side view of another embodiment of aguidewire730, showing theguidewire730 in an expanded configuration. Theguidewire730 can have a coiledexpansion portion732 that can expand when deployed in the renal or other branch arteries. In some embodiments, theguidewire730 can be formed from a tube of Nitinol that can be formed so as to define a coiled expansion portion, and heat set so that the coiledexpansion portion732 defines a diameter that is larger than the desired vessel diameter. The force from the coiledexpansion portion732 expanding against the vessel wall can provide a frictional force that inhibits the guidewire from being inadvertently removed from the target branch vessel. In some embodiments, the coiledexpansion portion732 can have two or more, or four or more coils.
• In some embodiments, theguidewire730 can be advanced through a tubular guidewire sheath that terminates in the desired branch vessel location. As the coiledexpansion portion732 exits the distal end of the tubular guidewire sheath, the coiledexpansion portion732 can self-expand against the walls of the target vessel so as to bias theguidewire730 in the desired location. Alternatively, a two-way guidewire (i.e., one having sufficient compressive and tensile strength) can be advanced through theguidewire730 so as to elongate and, hence, radially collapse the coiledexpansion portion732.
• FIG. 37 is a section view of another embodiment of aguidewire740, showing theguidewire740 in an expanded configuration. Theguidewire740 can have a braided orwire expansion portion742 that can expand when deployed in the renal or other branch arteries. In some embodiments, theguidewire740 can be formed from a tube of Nitinol that can be formed so as to define a coiled expansion portion, and heat set so that the braided orwire expansion portion742 defines a diameter that is larger than the desired vessel diameter. Theexpansion portion742 can be formed from between approximately five and ten or more wires each having a diameter between approximately 0.003 in or less and approximately 0.005 in or more. In some embodiments, theexpansion portion742 can be formed from between approximately three and twelve or more wires. The force from theexpansion portion742 expanding against the vessel wall can provide a frictional force that inhibits the guidewire from being inadvertently removed from the target branch vessel.
• In some embodiments, theguidewire740 can be advanced through a tubular guidewire sheath that terminates in the desired branch vessel location. As theexpansion portion742 exits the distal end of the tubular guidewire sheath, theexpansion portion742 can self-expand against the walls of the target vessel so as to bias theguidewire740 in the desired location. Alternatively, a two-way guidewire (i.e., one having sufficient compressive and tensile strength) can be advanced through theguidewire740 so as to elongate and, hence, radially collapse theexpansion portion742.
• FIG. 38 is a side view of another embodiment of anendoluminal prosthesis745, showing thebranch grafts750 in an inverted position inside themain body748 of the prosthesis,745.FIG. 39 is a side view of the embodiment of theprosthesis745 shown inFIG. 38, showing thebranch grafts750 in an inverted position inside themain body748 of theprosthesis745 and showing an embodiment of anangiographic catheter751 being advanced through each of theinverted branch grafts750 and thefenestrations749. Some embodiments of theangiographic catheter751 can be configured such that an end portion thereof is biased to have a curved disposition. In some embodiments, this can be accomplished by shortening the length of the wall of one side of the end portion of theangiographic catheter751 as compared to the length of the wall of the other side of theangiographic catheter751.
• Some embodiments of theendoluminal prosthesis745 can have amain graft body748 having fenestrations oropenings749 therein andbranch grafts750 supported by themain graft body748. Though not required, an additional fenestration can be formed in afirst portion748aof themain graft body748 to accommodate blood flow to the SMA or otherwise. Alternatively, a branch graft (not illustrated) can be supported by themain graft body748 to accommodate the blood flow to the SMA.
• Theendoluminal prosthesis745 illustrated inFIG. 38 can have any of the same features, components, or other details as compared to any of the embodiments of the endoluminal prostheses disclosed (directly or by incorporation by reference) herein, including without limitation the embodiment of theendoluminal prosthesis100 illustrated inFIG. 10 and described above. As with theendoluminal prosthesis100 illustrated inFIG. 10 above, to accommodate positional adjustability of thebranch grafts750, thebranch grafts750 can be supported by the second orenlarged portion748bof themain graft body748.
• In some embodiments, thebranch grafts750 can be integrally formed with themain graft body748. Alternatively, thebranch graft portions750 can be formed separately and later attached, adhered, sutured, or otherwise fastened or supported by themain graft body748. Additionally, in some embodiments, before theendoluminal prostheses745 is loaded into a delivery catheter,angiographic catheters751 or hollow guidewires can be advanced through thebranch grafts750 andfenestrations749. As is illustrated, in some embodiments, theangiographic catheters751 can define a lumen therethrough so that they can be passed or advanced overguidewires752 that are pre-wired in the patient's vasculature to guide theendoluminal prostheses745 to the target location. Advancing theangiographic catheters751 over thepre-wired guidewires752 can also facilitate the alignment of each of thebranch grafts750 with each of the branch vessels in the patient's vasculature.
• As illustrated, in some embodiments, thebranch grafts750 can be inverted and positioned within themain body748 of theprosthesis745 during the initial steps of deployment of theprosthesis745. In some embodiments of this configuration, theprosthesis745 may be easier to advance to and deploy at the target vessel location when thebranch grafts750 are inverted and positioned within themain body748 of theprosthesis745. Additionally, in some embodiments, the prosthesis may be configured such that thebranch grafts750 can be advanced through thefenestrations749 in themain body748 of theprosthesis745 and into the desired branch vessels after themain body748 of theprosthesis745 has been positioned in the target vessel location.
• In some embodiments, one ormore stents757 can be deployed or expanded within thebranch grafts750 after the branch grafts have been advanced into the branch vessels. Thestents757, or any other stents disclosed (directly or by incorporation by reference) herein, can be balloon expandable, self-expandable, flared, flareable, or be of any other suitable configuration or material, and can be carried or supported within aguidewire catheter sheath754. With reference to the figures, theprosthesis745 can be configured such that thestents757 are affixed to an end portion of thebranch grafts750 such that thebranch grafts750 can be inverted and advanced through thefenestrations749 found in themain graft body748 and into the branch vessels by advancing thestents757 distally through theguidewire catheter sheath754. In some embodiments, thestents757 can be advanced distally through theguidewire catheter sheath754 by advancing apusher catheter755 that is radially supported but axially unrestrained within theguidewire catheter sheath754.
• FIG. 40 is a section view of the embodiment of theprosthesis745 shown inFIG. 38, taken through line40-40 inFIG. 39. With reference toFIG. 40, theangiographic catheters751 can be configured to be axially advanceable over theguidewires752. Further, apusher catheter755 can be housed within eachguidewire catheter sheath754 so as to be axially advanceable over eachangiographic catheter751 and within theguidewire catheter sheath754.
• FIG. 41 is a section view of the embodiment of theprosthesis745 shown inFIG. 40, taken through line41-41 inFIG. 39. With reference toFIG. 41, theangiographic catheter751 can be configured to be axially advanceable over aguidewire752. Further, thestents757 can be housed within theguidewire catheter sheath754 so as to be axially advanceable over theangiographic catheter751 and within theguidewire catheter sheath754.FIG. 42 is a section view of the embodiment of theprosthesis745 shown inFIG. 38, after thebranch grafts750 have been advanced through thefenestrations749 in themain body748 of the embodiment of theprosthesis745 shown inFIG. 38.
• In some embodiments, theangiographic catheters751 can be made from a plastic extrusion or metal braids. For example, in some embodiments, the hollowangiographic catheters751 can be made from braided Nitinol wire. In some embodiments, the outer diameter of theangiographic catheters751 can be approximately 0.035 in and the lumen of the guidewire can be approximately 0.016 in to accommodate a second 0.014 in guidewire. In some embodiments, theangiographic catheters751 can be configured to pass over a 0.018 in or any other suitable guidewire. In some embodiments, the outer diameter of theangiographic catheters751 can be approximately 5 Fr and the lumen of the guidewire can be approximately 0.040 in to accommodate a second 0.035 or 0.038 in guidewire. In some embodiments, theangiographic catheters751 can be configured to pass over a 0.018 in or any other suitable guidewire. In some embodiments, theangiographic catheters751 can be configured to support balloons on the distal ends of theangiographic catheters751. The balloons can be inflated in the branch vessel to deploy expandable stents such asstents757 within thebranch grafts750.
• In some embodiments, each of thestents757 can be a bare metal stent or a covered stent (i.e., covered with a tubular shaped graft material). Additionally, in some embodiments, thestents757 can be self expanding or can be balloon expandable. Although not required, eachbranch graft750 can be fixed at an end portion thereof to an end portion of eachstent757. In some embodiments, each of thestents757 can be supported by or positioned over an expansion balloon positioned within each of theguidewire catheter sheaths754. The balloons can be slideable within theguidewire catheter sheaths754 so that the balloons can be advanced distally simultaneously with thestents757. In some embodiments, the balloons can be slideable over theangiographic catheters751 so that the balloons can be advanced over theangiographic catheters751 as thestents757 are advanced over theangiographic catheters751. The balloons can be expanded to deploy thestents757 once thestents757 are positioned in the target location within the branch vessels.
• Alternatively, in some embodiments, theangiographic catheters751 can be retracted after thestents757 are positioned in the target location within the branch vessels. Thereafter, one or more balloons supported by a guidewire catheter, balloon catheter, or other suitable catheter can be advanced over theguidewires752 and into the branch vessels to expand or otherwise deploy thestents757.
• Accordingly, in some embodiments, theangiographic catheters751 can be configured to allow for the inflation and expansion of expansion balloons so as to expand or deploy thebranch stents757. For example, theangiographic catheters751 can have a first lumen that can be advanced over a pre-wired guidewire and a second inflation lumen configured to communicate a positive pressure to the expansion balloon or balloons.
• In some embodiments, theendoluminal prostheses745 can be loaded into a delivery catheter so that each of theangiographic catheters751 protrudes out from the inside of theguidewire catheter sheath754 so that each of theangiographic catheters751 can be advanced over thepre-wired guidewires752 positioned within the patient's vasculature. Thus, during deployment, in some embodiments, each of thestents757 can be expanded and, hence, deployed within each of thebranch grafts750 after each of thebranch grafts750 has been advanced into the respective branch vessels. In some embodiments, each of thestents757 can be expanded and, hence, deployed within each of thebranch grafts750 before themain graft body748 has been secured in the main target vessel.
• However, as mentioned, the pre-positioning of thestents757 and/or the balloons in theendoluminal prostheses745 described above is not required. In some embodiments, one or more stents can be advanced through the patient's vasculature and into thebranch grafts750 after theendoluminal prostheses745 has been positioned within the target vessel in the patient's vasculature. For example, one or more stents can be advanced through the patient's vasculature into thebranch grafts750 after thebranch grafts750 have been inverted and advanced into the target branch vessels and after themain graft body748 has been secured within the main target vessel.
• In some embodiments, the hollowangiographic catheters751 can pass through a distal end opening of an outer sheath of a deployment catheter, just as with thedelivery catheter330 described above. As mentioned, each of the hollowangiographic catheters751 can be configured to receive or allow the insertion of a 0.014 in guidewire, a 0.018 in guidewire, a 0.035 in guidewire, or any diameter guidewire therethrough deemed suitable for the design. In some embodiments, the outer diameter of theangiographic catheters751 can be approximately 5 Fr and the lumen of the guidewire can be approximately 0.040 in to accommodate a second 0.035 or 0.038 in guidewire. In some embodiments, theangiographic catheters751 can be configured to pass over a 0.018 in or any other suitable guidewire. In this configuration, the hollowangiographic catheters751 can pass overguidewires752 that can be pre-wired in the target vessels so that the deployment catheter housing theprosthesis745 can be advanced along theguidewires752 pre-wired in the patient's vasculature, similar to any of the other embodiments of the deployment catheters disclosed or incorporated by reference herein or any other suitable catheter configurations known in the field.
• In some embodiments, once theendoluminal prosthesis745 has been advanced to the target location along theguidewires752 within the patient's vasculature, theguidewire catheter sheaths755 and thepusher catheters755 can be advanced through each of thefenestrations749 in themain body748 of theprosthesis745. Advancing theguidewire catheter sheaths755 and thepusher catheters755 through each of thefenestrations749 in themain body748 of theprosthesis745 can cause eachbranch graft750 to be advanced through thefenestrations749 and to invert and slide over an end portion of eachguidewire catheter sheath755 and slide around an outside surface of eachguidewire catheter sheath755, so that eachbranch graft750 can extend in the appropriate orientation in each of the branch vessels.
• In this arrangement, an end portion of theguidewire catheter sheath755 can be positioned within thebranch graft750 after thebranch graft750 has been advanced into the branch vessel as described above. Thereafter, in some embodiments, thepusher catheter755 can be used to hold thestent757 in the target location while theguidewire catheter sheath755 is retracted. If thestent757 is self-expandable, retracting theguidewire catheter sheath755 will permit thestent757 to self-expand radially outwardly, thereby securing thebranch graft750 in the target location. If thestent757 is not self-expandable, theangiographic catheter751, a balloon catheter, or other suitable instrument can be used to expand and deploy thestent757 in the target location. Each of thebranch grafts750 can be deployed sequentially or simultaneously in this arrangement. A stent or other suitable device can be deployed within themain graft body748 to secure themain graft body748 within the main vessel.
• As mentioned, although not required, eachbranch graft750 can be fixed at an end portion thereof to an end portion of eachstent757. In some embodiments, an end portion of thebranch graft750 can be affixed to at least a proximal end portion of therespective stent757 so that the branch graft250 can substantially completely cover an inside and an outside surface of thestent757 after thebranch graft750 has been inverted and advanced into the branch vessel.
• Additionally, in some embodiments, one or more of thepre-wired guidewires752 described above can be configured to be insertable into a branch vessel and to be biased such that an end portion of theguidewires752 remains in the branch vessel, such as with any of the guidewires. In particular, one or more of theguidewires752 can be configured to have the same features as, without limitation, any ofguidewires700,720,730, or740 disclosed herein.
• FIG. 43A is a side view of another embodiment of acatheter system1000 comprising an embodiment of an introducer catheter1002 (also referred to as an introducer) and an embodiment of adelivery catheter1004. Thedelivery catheter1004 can be configured for the delivery of an endoluminal prosthesis, including without limitation any endoluminal prosthesis embodiment disclosed herein or any other suitable prosthesis, or for any other suitable use. Therefore, the embodiments of the catheters and introducers disclosed herein can be configured for any suitable purpose, including deployment of a stent graft system as described herein.
• FIG. 43B is a perspective view of the embodiment of acatheter system1000 illustrated inFIG. 43A, showing anouter sheath1006 of thedelivery catheter1004 in a partially retracted position. With reference toFIGS. 43A and 43B, some embodiments of theouter sheath1006 can be used to constrain at least a portion of aprosthesis1010. In some embodiments, theprosthesis1010 can have any of the same features, components, or other details of any of the other prosthesis embodiments disclosed herein, including without limitation the embodiments of theprosthesis1200 described below. Theprosthesis1010 can have any number of stents or other support members, connectors, grafts, cuts, fenestrations, or other suitable components or features. As used herein, when referring to theprosthesis1010, distal refers to the end of the prosthesis that is further from the patient's heart, and proximal refers to the end of the prosthesis that is closer to the patient's heart. As used herein with regard to the embodiments of thecatheter system1000, the term distal refers to the end of the catheter system that is further from the surgeon or medical practitioner using the catheter system, and the term proximal refers to the end of the catheter system that is closer to the surgeon or medical practitioner.
• In some embodiments, as illustrated inFIG. 43, a distal sheath1012 (also referred to herein as a first restraint or first restraining means) can be used to constrain a proximal portion of thestent graft1010. Thedistal sheath1012 can be supported by adistal tip1014 of thecatheter system1000. In some embodiments, thedistal tip1014 can comprise an atraumatic material and design. As will be described in greater detail below, thedistal tip1014 and, hence, thedistal sheath1012 can be attached to aninner tube1016 to control the position of thedistal tip1014 and thedistal sheath1012 relative to aninner core1020 of thedelivery catheter1004. Theinner core1020 can be rotatable relative to theouter sheath1006 so that a prosthesis supported by thedelivery catheter1004 can be rotated during deployment. Theinner tube1016 can be slidably positioned coaxially within a lumen in anouter tube1018 that can connect asupport member1022 to theinner core1020. In some embodiments, theouter tube1018 can be connected to an opening orpartial lumen1019 in theinner core1020 so as to be axially and rotationally fixed to theinner core1020.
• In this configuration, thecatheter system1000 can be configured such that advancing theinner tube1016 relative to aninner core1020 of thedelivery catheter1004 can cause thedistal sheath1012 to be advanced relative to theprosthesis1010, causing the proximal portion of theprosthesis1010 to be deployed. The prosthesis1010 (or any other prosthesis disclosed herein) can be at least partially self-expanding such that, as the tubulardistal sheath1012 is advanced relative to theprosthesis1010, a proximal portion of theprosthesis1010 expands against a vessel wall. In some embodiments, only some segments or portions of theprosthesis1010 such as, without limitation, portions of the prosthesis axially adjacent to englarged graft portions of the prosthesis, can be configured to be self-expanding.
• Theinner core1020 can be slideably received within theouter sheath1006 of thedelivery catheter1004. In some embodiments, as in the illustrated embodiment, theouter sheath1006 of thedelivery catheter1004 can be longer than anintroducer sheath1008 of theintroducer catheter1002. Further, aclip1007 can be supported by theouter sheath1006 to limit the range of axial movement of theouter sheath1006 relative to theintroducer catheter1002.
• In some embodiments, although not required, acore assembly1021 can be connected to a proximal end portion of theinner core1020, thecore assembly1021 having a reduced cross-sectional profile so as to permit one or more sheath members, push catheters, or other tubular or other components to pass through the main body of thedelivery catheter1004 and be advanced into one or more lumen within theinner core1020. In some embodiments, theinner core1020 can be configured to accommodate the insertion of such sheath members, push catheters, or other tubular components into the lumen of theinner core1020.
• In the illustrated embodiment, a proximal end portion of thecore assembly1021 can comprise ahandle member1023 that is positioned outside a proximal end portion of thedelivery catheter1004 so as to be accessible by a user. Thehandle member1023 can be configured to permit a user to axially or rotationally adjust the position of theinner core1020 relative to theouter sheath1006.
• As discussed above, theinner core1020, or components axially connected to theinner core1020 such as thecore assembly1021, can extend proximally past theproximal end portion1004aof thedelivery catheter system1004 so that a user can adjust and/or change the axial and/or radial position of theinner core1020 and, hence, theprosthesis1010, relative to theouter sheath1006. Similarly, theinner tube1016 can extend proximally past theproximal end portion1004aof thedelivery catheter1004 and aproximal end portion1021aof thecore assembly1021 so that a user can adjust and change the position of theinner tube1016 relative to theinner core1020.
• In the partially retracted position of theouter sheath1006 illustrated inFIG. 43B, at least a portion of theprosthesis1010 supported by thecatheter system1000 can be exposed and, potentially, deployed. In some embodiments, a distal portion of theprosthesis1010 can be exposed and deployed by retracting theouter sheath1006 relative to theinner core1020 or distally advancing theinner core1020 relative to theouter sheath1006, causing at least a portion of the distal portion of theprosthesis1010 to self-expand. As will be described, some embodiments of theprosthesis1010 can be configured to have radially self-expanding support members therein along only a portion or portions of theprosthesis1010. For example, without limitation, some embodiments of a graft of theprosthesis1010 can be radially unsupported at or adjacent to fenestrations formed in the graft. Alternatively, in some embodiments, at least the distal portion of theprosthesis1010 can be constrained within a sheath, such as a peelable sheath. Embodiments of the sheath will be described in greater detail below.
• 102511 Thedelivery catheter1004 can also have one or more branch or guidesheaths1024 supported thereby. In some embodiments, thedelivery catheter1004 can have three ormore branch sheaths1024. Such a configuration can be used for deploying branch stents into one or more branch vessels in the thoracic aorta. Each of the one ormore branch sheaths1024 can be configured to be slideably supported within one ormore lumen1025 formed in theinner core1020 so that each of the one ormore branch sheaths1024 can be axially advanced or retracted relative to theinner core1020. Further, some embodiments of thedelivery catheter1004 can be configured such that thebranch sheaths1024 can be rotationally adjusted or twisted relative to theinner core1020. In some embodiments, eachbranch sheath1024 can be positioned within thedelivery catheter1004 such that, in the loaded configuration wherein aprosthesis1010 is supported within thedelivery catheter1004, eachbranch sheath1024 is pre-positioned so as to be advanced through a fenestration or branch graft of theprosthesis1010. Eachbranch sheath1024 can be positioned within thedelivery catheter1004 such that a distal end portion of eachbranch sheath1024 projects past an end portion of theinner core1020 and is constrained within theouter sheath1006. As illustrated inFIGS. 43A-43B, in this configuration, the distal end portion of eachbranch sheath1024 can be exposed by retracting theouter sheath1006 relative to theinner core1020 and/or thebranch sheaths1024.
• Additionally, with reference toFIG. 43B, in some embodiments, although not required, thedelivery catheter1004 can have one ormore push catheters1026 supported thereby. In some embodiments, the one ormore push catheters1026 can be slideably received within one ormore lumen1027 formed in theinner core1020. In some embodiments, the one ormore push catheters1026 can each have anend portion1026athat can be sized and configured to surround an outer surface of each of thebranch sheaths1024. Theend portion1026aof eachpush catheter1026 can have, without limitation, an open or closed annular or circular shape and can be of sufficient size and stiffness to permit a user to engage a fenestration or branch graft formed in or supported by a main body of theprosthesis1010. For example, as will be described in greater detail below, after the main body of theprosthesis1010 has been released from theouter sheath1006 and any other radial restraints, a user can independently or collectively axially advance thepush catheter1026 over thebranch sheaths1024 such that theend portion1026aof eachpush catheter1026 engages the fenestration or branch graft of theprosthesis1010 and pushes the fenestration or branch graft toward an ostium of the target branch vessel of the patient's vasculature.
• Accordingly, in this configuration, at least a portion of each of the one ormore push catheters1026 can be configured to be slideably supported within a lumen formed in theinner core1020 so that each of the one ormore push catheters1026 can be axially advanced relative to theinner core1020. Further, some embodiments of thedelivery catheter1004 can be configured such that thepush catheters1026 can be axially or rotationally adjusted or twisted relative to theinner core1020, for increased maneuverability of thepush catheters1026.
• In some embodiments, eachpush catheter1026 can be positioned within thedelivery catheter1004 such that, in the loaded configuration wherein aprosthesis1010 is supported within thedelivery catheter1004, eachpush catheter1026 is pre-positioned so that theend portion1026aof eachpush catheter1026 is positioned distal to the end portion of theinner core1020. In some embodiments, in the loaded configuration, eachpush catheter1026 can be positioned such that theend portion1026aof eachpush catheter1026 is located within the main lumen of the main body of theprosthesis1010. As mentioned, in some embodiments, one or more of thebranch sheaths1024 can have a loop, protrusion, snare, or other similar feature supported thereby, or otherwise be configured to enable thesheath1024 to engage a fenestration or branch graft to advance the fenestration or branch graft toward the ostium of the target branch vessel by advancing thebranch sheath1024.
• Thebranch sheaths1024 and pushcatheters1026 can have any suitable size and can be made from any suitable material. For example, without limitation, thebranch sheaths1024 can have an approximately 6.5 French diameter, or from an approximately 5 Fr diameter or less to an approximately 8 Fr diameter or more, or to or from any values within this range. Thepush catheters1026 can be formed from stainless steel, Nitinol, or any other suitable metallic or non-metallic material, and can have a thickness suitable to prevent thepush catheters1026 from buckling when axially advanced against a portion of theprosthesis1010. For example, without limitation, thepush catheters1026 can have an approximately 1 Fr diameter, or between approximately a 1 Fr and approximately a 4 Fr diameter. Further, some embodiments of the push catheter or catheters can be formed from a 0.035 in guidewire or otherwise have a 0.035 in diameter.
• Additionally, as will be described below in greater detail, thecatheter system1000 can be configured such that thedistal sheath1012 can be advanced relative to theinner core1020 and theprosthesis1010, to expose a proximal portion of theprosthesis1010. In particular, in some embodiments, advancing thedistal sheath1012 can be accomplished by advancing theinner tube1016 connected to thedistal tip1014 and thedistal sheath1012, so that thedistal sheath1012 releases the proximal portion of theprosthesis1010. Other details regarding thedistal sheath1012 or methods of using the distal sheath can be found in U.S. Pat. No. 6,953,475, which application is incorporated by reference as if fully set forth herein.
• FIGS. 44 and 45 are a perspective view and an exploded view, respectively, of the embodiment of theintroducer catheter1002 shown inFIG. 43. In some embodiments, theintroducer catheter1002 can have any of the features or components of any of the embodiments disclosed in U.S. patent application Ser. No. 12/496,446, which disclosure is hereby incorporated by reference as if set forth herein. With reference toFIGS. 44-45, in some embodiments, theintroducer1002 can have amain body1030, a threadably engageblehub portion1032, a threadedcap1034 configured to threadably engage with a threadeddistal end portion1030aof themain body1030 so as to secure theouter sheath1006 to themain body1030. Theouter sheath1006 can have aflanged end portion1036 secured thereto or integrally formed therewith. Themain body1030 can support aseal assembly1040 therein to seal around theinner core1020 of thedelivery catheter1004 and/or other components of thecatheter system1000. A threadedend member1042 having a threadedproximal end portion1042acan be supported by themain body1030. Anannular seal member1046 can be supported by themain body1030 of theintroducer catheter1002. Theintroducer catheter1002 can be configured such that theseal member1046 can be adjusted to provide an additional seal around theinner core1020 of thedelivery catheter1004 by threadedly engaging thehub portion1032. Theseal assembly1040 andseal member1046 can have any of the details, features, or components of any of the embodiments of the introducer catheter described in U.S. patent application Ser. No. 12/496,446, which application is incorporated by reference as if fully set forth herein.
• In some embodiments, atube assembly1048 can be supported by themain body1030 of theintroducer catheter1002 so as to provide an orifice or access port into themain body1030. Thetube assembly1048 can be used to flush theintroducer catheter1002 with saline or other suitable substances at any stage, such as but not limited to prior to the advancement of an endoluminal prosthesis through theintroducer catheter1002 and/ordelivery catheter1004, or prior to other procedures for which another type of delivery catheter may be used. Thetube assembly1048 can support any suitable medical connector and/or valve on the distal end thereof.
• FIGS. 46 and 47 are a perspective view and an exploded view, respectively of the embodiment of thedelivery catheter1004 shown inFIG. 43.FIG. 48 is a section view of a portion of the embodiment of thedelivery catheter1004 shown inFIG. 43, defined by curve48-48 shown inFIG. 43A.FIG. 49A is a section view of the embodiment of thedelivery catheter1004 shown inFIG. 43, defined by theline49A-49A shown inFIG. 48.FIG. 49B is a section view of the embodiment of thedelivery catheter1004 shown inFIG. 43, defined by theline49B-49B shown inFIG. 48.
• As shown therein, some embodiments of thedelivery catheter1004 can have amain body1050 that can support theinner core1020 and/orcore assembly1021, one ormore access ports1052 for the one ormore branch sheaths1024, and one ormore access ports1054 for the one ormore push catheters1026. Theaccess ports1052,1054 can be configured to sealingly tighten around thebranch sheaths1024 or thepush catheters1026, and to constrict around thebranch sheaths1024 or thepush catheters1026 so as to substantially axially secure thebranch sheaths1024 or thepush catheters1026. Asealable cap assembly1051 can be threadingly engaged with themain body1050 of thedelivery catheter1004. Thecap assembly1051 can be configured such that, when a user tightens thecap assembly1051 relative to themain body1050 of thedelivery catheter1004, thecore assembly1021 and/orinner core1020 will be axially and/or rotational secured to themain body1050 of thedelivery catheter1004.
• In some embodiments, atube assembly1059 can be supported by themain body1050 of thedelivery catheter1004 so as to provide an orifice or access port into themain body1050. Thetube assembly1059 can be used to flush thedelivery catheter1004 with saline or other suitable substances. Thetube assembly1059 can support any suitable medical connector and/or valve on the distal end thereof.
• As mentioned above, thesupport member1022 can be connected to a distal end portion of theouter tube1018 so as to be axially engaged by theouter tube1018. Some embodiments of thesupport member1022 can have a substantially cylindrical shape and can be sized to fit within the inner lumen of a main body of theprosthesis1010 when theprosthesis1010 is in a constrained configuration. As will be described, in the loaded configuration, theprosthesis1010 can be positioned over thesupport member1022 so that a proximal portion of a main body of theprosthesis1010 is positioned distally of thesupport member1022 and so that a distal portion of a main body of theprosthesis1010 is positioned proximally of thesupport member1022. In this configuration, aproximal end portion1012aof thedistal sheath1012 can be positioned over adistal portion1022aof thesupport member1022, and a distal end portion1006aof theouter sheath1006 over aproximal portion1022bof thesupport member1022.
• In some embodiments, one ormore tab members1074 can be supported by theouter tube1018. The one ormore tab members1074 can be configured to increase the rotational engagement of the constrainedprosthesis1010 relative to theouter tube1018 so that the constrainedprosthesis1010 can be rotated with greater accuracy during deployment. Some embodiments of the one ormore tab members1074 can have a generally flat, plate-like shape, such as is illustrated inFIG. 46. The one ormore tab members1074 can be formed from a suitable polymeric or metallic material. Some embodiments of the one ormore tab members1074 can comprise one or more radiopaque features or be formed from a radiopaque material to improve the visibility and alignability of thedelivery catheter1004 under fluoroscopy during deployment of theprosthesis1010.
• In some embodiments, the one ormore tab members1074 can be similar to any of the embodiments of the torsion tab (such as without limitation, the embodiment of the torsion tab196) disclosed in U.S. patent application Ser. No. 12/101,863, which disclosure is incorporated by reference as if fully set forth herein. In some embodiments, the one ormore tab members1074 can be integrally formed with theouter tube1018, or secured thereto such as by thermal bonding, adhesive bonding, and/or any of a variety of other securing techniques known in the art.
• As is illustrated, the main body portion of theprosthesis1010 can be constrained by a peelable sheath or by theouter sheath1006 such that theprosthesis1010 is engaged with the one ormore tab members1074. In some embodiments, the one ormore tabs1074 can engage a stent or other portion of an endoskeleton of theprosthesis1010, or, in some embodiments, can engage the material of thegraft1204 surrounding thetab member1074 so that theprosthesis1010 can substantially rotate with theinner core1020 of thedeployment catheter1004.
• FIG. 50 is a side view of the embodiment of thecatheter system1000 shown inFIG. 43, showing theouter sheath1006 in a partially retracted position, similar to the configuration shown inFIG. 43B.FIG. 51 is an enlarged side view of the embodiment of the catheter system shown inFIG. 43, defined by curve51-51 ofFIG. 50, showing theouter sheath1006 in a partially retracted position.
• With reference toFIG. 51, in some embodiments, the mid portion of theprosthesis1010 adjacent to the one or more fenestrations1011 and/or thedistal portion1010aof the prosthesis can be constrained within apeelable sheath1060. Thepeelable sheath1060 can have arelease wire1062 threadably advanced through a plurality ofopenings1064 formed along at least a portion of thesheath1060. In some embodiments, thepeelable sheath1060,release wire1062, andopenings1064 can have any of the same features, materials, or other details of the similar components disclosed in U.S. patent application Ser. No. 12/101,863, which application is incorporated by reference as if fully set forth herein. In some embodiments, therelease wire1062 can be slideably received within a lumen in theinner core1020 so that a user can retract therelease wire1062 by grasping and retracting a proximal portion of therelease wire1062 positioned outside the patient's body.
• However, in some embodiments (not illustrated), the mid portion of theprosthesis1010 adjacent to the one or more fenestrations1011 and/or thedistal portion1010aof the prosthesis can be constrained within one or more tubular sheaths, such as the outer sheath1006 (also referred to herein as a second restraint or second restraining means) and/ordistal sheath1012 such that additional restraining means such as thesheath1060 are not required. Therefore, any of the embodiments disclosed herein having theoptional sheath1060 should be understood to be configurable to not use thesheath1060 to restrain one or more portions of theprosthesis1010. In some embodiments, theprosthesis1010 can be configured such that the mid portion of theprosthesis1010 adjacent to the one or more fenestrations1011 is not radially supported by a stent, connectors, struts, or any other similar structure such that, when theouter sheath1006 is partially retracted, the mid portion of the prosthesis does not self-expand.
• In some embodiments, theprosthesis1010 can have one ormore openings1011 formed therein. For example and without limitation, the fenestrations oropenings1011 can be formed in theprosthesis1010 at diametrically opposing positions. As will be described in greater detail below, in some embodiments, one or more of theopenings1011 can be formed in theprosthesis1010 at a position that is angularly offset from the diametrically opposing position. Similarly, in some embodiments, when used, thesheath1060 can have one ormore openings1061 formed therein, theopenings1061 being positioned adjacent to the similar number ofopenings1011 formed in the prosthesis. Some embodiments of thecatheter system1000 can be configured such that thesheaths1024 are advanced through theopenings1011 formed in theprosthesis1010 and theopenings1061 formed in thesheath1060, when theprosthesis1010 is loaded within thecatheter system1000.
• With reference toFIG. 49B, due to the non-uniform design of the stent within the graft material, in some embodiments, theprosthesis1010 can be efficiently packed within theouter sheath1006 so as to surround thesheaths1024 and efficiently fill the space within theouter sheath1006. In this configuration, for example, theprosthesis1010 can be loaded within theouter sheath1006 so that thesheaths1024 are advanced between many of the struts, bends, loops, and other features that the stent can comprise, thereby permitting thesheaths1024 sufficient space to be loaded within theouter sheath1006 so that the lumen of thesheaths1024 are not compressed or collapsed in the loaded state. Additionally, the graft can be formed from a bi-directionally expanded, layered PTFE material have thin walls to further increase the space efficiency of theprosthesis1010.
• In some embodiments, as illustrated inFIG. 51, where used, thepeelable sheath1060 can have one or more release wires1062 (two being shown) advanced through openings orperforations1064 formed in thesheath1060 along two sides of thesheath1060. Therelease wires1062 can be configured to tear thesheath1060 along two lines ofperforations1064 and/or scores formed along two sides of thesheath1060, so that thesheath1060 can be removed from theprosthesis1010 while thesheaths1024 are advanced through thefenestrations1011,1061, respectively, in theprosthesis1010 andsheath1060. In this configuration, each of the tworelease wires1062 can be secured to aproximal end portion1060aof thesheath1060, so that both halves of thesheath1060 can be retracted through theouter sheath1006.
• However, as illustrated inFIG. 52, some embodiments of thecatheter system1000 can be configured to only have onerelease wire1062 threadedly advanced through thesheath1060.FIG. 52 is an enlarged side view of the embodiment of thecatheter system1000 shown inFIG. 43, defined by curve52-52 shown inFIG. 50, showing theouter sheath1006 in a partially retracted position and thedistal sheath1012 in a partially advanced position.
• In some embodiments, theperforations1064 formed in thesheath1060 can be arranged along an axial line along the length of the portion of thesheath1060 from thefenestrations1061 to the distal end of thesheath1060, and also arranged to split thesheath1060 between the twofenestrations1061 formed in thesheath1060. In some embodiments, as illustrated inFIG. 52, theperforations1064 formed in thesheath1060 arranged along the length of thesheath1060 can be positioned to tear thesheath1060 from one of thefenestrations1061 to thedistal end1060bof thesheath1060, and also to circumferentially tear thesheath1060 between thefenestrations1061.
• As mentioned above, with reference toFIG. 52, some embodiments of thecatheter system1000 can be configured such that aproximal portion1010bof theprosthesis1010 can be deployed by axially advancing theinner tube1016 relative to theinner core1020 of thedelivery catheter1004 and, hence, theprosthesis1010. Some embodiments of theprosthesis1010 can be self-expanding such that removing the radial constraint provided by thedistal sheath1012 can cause the portion of theprosthesis1010 constrained by theinner tube1016 to expand toward the vessel wall. In some embodiments, theproximal portion1010bof theprosthesis1010 can be deployed in this manner before thedistal portion1010aof theprosthesis1010 is deployed, or simultaneously with the deployment of thedistal portion1010aof theprosthesis1010. In some embodiments, theproximal portion1010bof theprosthesis1010 can be deployed in this manner after thedistal portion1010aof theprosthesis1010 is deployed.
• FIG. 53 is a side view of the embodiment of thecatheter system1000 shown inFIG. 43, showing theouter sheath1006 in a partially retracted position and the embodiment of onebranch sheath1024′ and onepush catheter1026′ in a partially advanced position. Thebranch sheath1024′ can be advanced relative to theinner core1020, the prosthesis, and thesecond branch sheath1024″ by advancing a proximal portion of thebranch sheath1024′ in the direction of arrow A1 inFIG. 53 through theaccess port1052′ at the proximal end of thedelivery catheter1004. Similarly (not shown), thesecond branch sheath1024″ can be advanced relative to theinner core1020, the prosthesis, and thefirst branch sheath1024′ by advancing a proximal portion of thebranch sheath1024″ through theaccess port1052″ at the proximal end of thedelivery catheter1004. Additionally, either of thepush catheters1026′,1026″ can be advanced relative to thebranch sheaths1024′,1024″ by advancing therespective push catheter1026 through therespective access port1054. For example, thepush catheter1026′ can be advanced by advancing the proximal portion of thepush catheter1026′ in the direction of arrow A2 inFIG. 53.
• With the embodiments of thecatheter system1000 having been described, several configurations of deployment methods for an endoluminal prosthesis, including any suitable prosthesis or any endoluminal prosthesis disclosed herein, will now be described with reference toFIGS. 54-61.FIG. 54 is a section view of a portion of a patient's vasculature, showing thedelivery catheter1000 being advanced through a patient's abdominal aorta over aguidewire1070 positioned within a patient's vasculature. In some embodiments, as in the illustrated embodiment, thedelivery catheter1000 can be advanced through a prosthesis1080 (which can be a bifurcated prosthesis) deployed within the patient's vasculature.
• FIG. 55 is a section view of a portion of a patient's vasculature, showing thedelivery catheter1000 and anangiographic catheter1065 being advanced through abranch sheath1024 of the delivery catheter toward a target branch vessel. As illustrated, anouter sheath1006 of thecatheter system1000 has been retracted relative to the inner core (not shown) and theprosthesis1010, exposing a middle portion of the prosthesis1010 (i.e., a portion of theprosthesis1010 radially adjacent to the one or more fenestrations1011) and thebranch sheaths1024a,1024b.In some embodiments, after thebranch sheaths1024a,1024bhave been exposed, a suitableangiographic catheter1065 can be advanced through the lumen of either or both of thebranch sheaths1024a,1024band directed into the target branch vessel or vessels. A user can rotate theinner core1020 to approximately rotationally align thefenestrations1011 of theprosthesis1010 or thebranch sheaths1024 with the branch vessels.
• In some embodiments, as discussed above, theoptional sheath1060 can constrain the mid and distal portions of theprosthesis1010 such that, when theouter sheath1006 is retracted, the mid and distal portions of theprosthesis1010 do not self-expand. However, in some embodiments, the mid portion of theprosthesis1010 radially adjacent to the one or more fenestrations1011 can be unsupported by any stents, struts, connectors or can be minimally supported by stents or connectors1254 (also referred to herein as connecting members). In some embodiments of this configuration, theprosthesis1010 can be configured such that there is no radial force or support provided to the mid portion of theprosthesis1010, or such that the mid portion of theprosthesis1010 will not be biased to self-expand when theouter sheath1006 is retracted. Accordingly, some embodiments can be configured such that no additional restraint in addition to, for example, theouter sheath1006, is required. Therefore, in some embodiments, only theouter sheath1006 and thedistal sheath1012 can be used to restrain theprosthesis1010. In this configuration, theouter sheath1006 can be partially retracted to release thesheaths1024 so that one or moreangiographic catheters1065 can be advanced through thesheaths1024 and into the target branch vessels before the proximal and distal portions of theprosthesis1010 are released from thedeployment catheter1004.
• Some embodiments of theangiographic catheter1065 can be configured such that an end portion thereof is biased to have a curved disposition. In some embodiments, this can be accomplished by shortening the length of the wall of one side of the end portion of theangiographic catheter1065 as compared to the length of the wall of the other side of the angiographic catheter162. In some embodiments, an end portion of thesheaths1024 can be also be formed so as to be biased to have a curved end portion. Some embodiments of thesheaths1024 can be formed in this configuration by heat setting an end portion of the sheath in a curved disposition, or by otherwise shortening the wall of one side of the end portion of the catheter as compared to the other side of the end portion of the catheter. In some embodiments, thebranch sheaths1024 can have a curved end portion so thatsuch sheaths1024 can be directed into the branch arteries or vessels without the use of an angiographic catheter.
• As shown, anangiographic catheter1065 is being advanced relative to thebranch sheath1024aand into the target branch vessel, in this case a renal artery. Some embodiments of thedelivery catheter1000 can be configured such that an angiographic catheter can be advanced through the desiredbranch sheath1024 and into the target vessel without retracting theouter sheath1006. After theangiographic catheters1065 have been directed into the target location, in this case the branch vessels, either or both of thebranch sheaths1024 can be independently or simultaneously advanced over theangiographic catheters1065 into the target branch vessels, as is illustrated inFIG. 56. In some embodiments, thebranch sheaths1024, thefenestrations1011,1061 formed in either theprosthesis1010 or thesheath1060, respectively, and/or any other components or features of thedelivery catheter1000 can have radiopaque markers or other indicators to assist a medical practitioner in the deployment procedures described herein or other suitable deployment procedures.
• With thebranch sheaths1024 in the target vessels and theouter sheath1006 axially retracted, as shown inFIG. 57, aproximal portion1010bof theprosthesis1010 can be deployed by axially advancing thedistal sheath1012 relative to theinner core1020 and theprosthesis1010. In some embodiments, theprosthesis1010 can be axially and rotationally secured to theouter tube1018, which can be axially and rotationally secured to theinner core1020, such that advancing thedistal sheath1012 relative to theinner core1020 will advance thedistal sheath1012 relative to theprosthesis1010. As described above, thedistal sheath1012 can be advanced relative to theinner core1020 and theprosthesis1010 by advancing theinner tube1016 relative to theinner core1020, theinner tube1016 being axially engaged with thedistal tip1014 which can support thedistal sheath1012.
• FIG. 58 is a section view of a portion of a patient's vasculature, showing an embodiment of apeelable sheath1060 being removed from thedistal portion1010aof theprosthesis1010 so as to deploy adistal portion1010aof theprosthesis1010. Some embodiments of thesheath1060 can be removed by axially retracting arelease wire1062, which can be looped or other otherwise threaded through openings orperforations1064 formed in the sheath material. Therelease wire1062 can be configured to tear through the sheath material between theperforations1064, thereby permitting the self-expandingprosthesis1010 to expand toward the vessel walls. As mentioned, some embodiments of theprosthesis1010 can be configured to be restrained within theouter sheath1006 and thedistal sheath1012 such that an additional restraint, such as thepeelable sheath1060, is not required.
• In some embodiments, as illustrated, adistal portion1060aof thesheath1060 can be torn by therelease wire1062 before aproximal portion1060bof thesheath1060 is torn by the release wire so that aproximal portion1010aof the prosthesis (i.e., adjacent to theproximal portion1060aof the sheath1060) can be deployed before adistal portion1010bof thesheath1010. In some embodiments (not illustrated), aproximal portion1060bor a middle portion of thesheath1060 can be torn by therelease wire1062 before adistal portion1060aof thesheath1060 is torn by the release wire. In some embodiments, therelease wire1062 can be secured to theproximal portion1060bor other suitable portion of thesheath1060 such that, after thesheath1060 has been torn, thesheath1060 can be removed through thedelivery catheter1000 by continuing to axially retract therelease wire1062 relative to theprosthesis1010.
• As illustrated, adistal portion1010bof the prosthesis1010 (i.e., the downstream portion of the prosthesis1010) can be deployed within an opening of an adjacent prosthesis, such as without limitation thebifurcated prosthesis1080 illustrated inFIG. 58. However, in some embodiments, thedelivery catheter1000 or any other delivery catheter described herein can be used to deploy any suitable prosthesis, including a bifurcated prosthesis or otherwise, in any portion of a patient's vasculature. As such, in some embodiments, theprosthesis1000 can be a bifurcated prosthesis.
• FIG. 59 is a section view of a portion of a patient's vasculature, showing an embodiment of apush catheter1026 advancing an inner wall of theprosthesis1010 adjacent to afenestration1011 toward an ostium of the target branch vessel. As illustrated, thepush catheter1026 can be advanced through a lumen in theinner core1020 to push thefenestration1011 of theprosthesis1010 over thebranch sheath1024 and into approximate alignment with the ostium of the branch vessel. In some embodiments, thecatheter system1000 can be configured to not have apush catheter1026, and can accordingly be configured to deploy a fenestrated graft without the use of such a component. As will be described below, in some embodiments, snares, protrusions, tabs, or other features can be formed on thesheaths1024 to push the fenestrations toward the branch vessel ostium.
• In some embodiments, as illustrated inFIG. 60, a covered or uncoveredbranch stent1084 can be deployed in the branch vessel by advancing thebranch stent1084 through thebranch sheath1024 using a suitable catheter, such as a renal stent catheter, into the target vessel, after the angiographic catheter has been removed from thebranch sheath1024. Thestent1084 can be supported on aninflation balloon1086, which can be supported by aguidewire1088. Theguidewire1088 can be configured to have an inflation lumen therein, to inflate theballoon1086 and expand thebranch stent1084 in the target location after thebranch sheath1024 has been at least partially retracted so as to not interfere with the expansion of thebranch stent1084, as illustrated inFIG. 61. In some embodiments, theinflation balloon1086 can be configured to expand and flare a portion of thestent1084 within or to the inside of thefenestration1011 formed in the prosthesis.
• Some embodiments of thepush catheter1026 described above can be configured to be supported within a renal or branch stent delivery catheter. For example, without limitation, thepush catheter1026 can be configured to be supported within a modified embodiment of a renal stent catheter, such as the renal stent catheter illustrated inFIG. 60. In some embodiments, thepush catheter1026 can be configured to only partially surround thebranch sheath1024 or the branch stent delivery catheter. In this configuration, thepush catheter1026 can be configured to be entirely positioned within and advanceable through a lumen of thebranch sheath1024 or the branch stent delivery catheter. For example, thepush catheter1026 can have an expandable end portion that can automatically expand when the end portion is advanced past the end of the lumen, so as to enable the end portion to snare or engage the graft material surrounding the fenestration.
• Additionally, in some embodiments, the branch stent delivery catheter can be configured to have a snare, protrusion, or other object tethered to the balloon or stent, or to be projecting from an outside surface thereof to snare or engage the graft material adjacent to the fenestration, so as to cause the fenestration to be advanced toward the ostium as the branch stent delivery catheter is advanced through the fenestrations. For example, without limitation, the branch stent delivery catheter can have a biased wire member supported on an outside surface of the branch stent delivery catheter that is biased to expand when the wire member is advanced past the end of thebranch sheath1024. The wire member can expand to a size that is larger than the size of the fenestration. The wire member can be supported at a position that is offset from an end of the branch stent delivery catheter.
• In some embodiments, thefenestration1011 in theprosthesis1010 can be expanded as thebranch stent1084 is being expanded, to improve the seal between thefenestration1011 and thebranch stent1084. In some embodiments, a second expansion balloon can be positioned in the portion of thestent1084 within or to the inside of thefenestration1011 to flare that portion of thestent1084, either with or without removing the first balloon used to expand the main portion of thebranch stent1084.
• Some arrangements are directed to methods of deploying an endoluminal prosthesis, such as without limitation theprosthesis1010 described above, comprising inserting a delivery catheter such ascatheter system1000 into an artery, exposing one ormore branch sheaths1024, advancing one or more angiographic catheters with one or more guidewires into the one ormore branch sheaths1024 and cannulating the target branch vessels, advancing the one ormore branch sheaths1024 over the angiographic catheters and into the target branch vessels, deploying a proximal portion of the prosthesis, deploying a distal portion of the prosthesis, removing the one or more angiographic catheters and/or the guidewires, inserting one or more branch stents into the branch vessels, retracting the branch sheaths, expanding the branch stents, and flaring a portion of the branch stents. The steps of the foregoing procedure can be performed in the sequence described, or can be performed in any suitable sequence. In some arrangements, the target branch vessels are the renal arteries. The step of deploying a distal portion of the prosthesis can be performed in some arrangements by tearing and retracting a peelable sheath member, or by retracting a tubular sheath such as an outer sheath. Deploying a proximal portion of the prosthesis can be performed in some arrangements by distally advancing a tubular sheath.
• Some arrangements are directed to methods of deploying an endoluminal prosthesis, such as without limitation theprosthesis1010 described above, comprising inserting a delivery catheter such ascatheter system1000 into an artery, exposing one ormore branch sheaths1024, advancing one or more angiographic catheters having one or more guidewires into the one ormore branch sheaths1024 and cannulating the target branch vessels, advancing the one ormore branch sheaths1024 over the angiographic catheters and into the target branch vessels, removing the one or more angiographic catheters and/or guidewires, inserting one or more branch stents into the branch vessels, retracting the branch sheaths, expanding the branch stents, and flaring a portion of the branch stents. The target branch vessels can be the renal arteries. The steps of the foregoing procedure can be performed in the sequence described, or can be performed in any suitable sequence.
• Some arrangements are directed to methods of deploying an endoluminal prosthesis, such as without limitation theprosthesis1010 described above, comprising inserting a delivery catheter such ascatheter system1000 into an artery, exposing one ormore branch sheaths1024, advancing one or more angiographic catheters having one or more guidewires into the one ormore branch sheaths1024 and cannulating the target branch vessels, advancing the one ormore branch sheaths1024 over the angiographic catheters and into the target branch vessels, deploying a prosthesis, removing the one or more angiographic catheters and/or guidewires, inserting one or more branch stents into the branch vessels, retracting the branch sheaths, expanding the branch stents, and flaring a portion of the branch stents. In some arrangements, the target branch vessels are the renal arteries. The steps of the foregoing procedure can be performed in the sequence described, or can be performed in any suitable sequence.
• Some arrangements are directed to methods of deploying an endoluminal prosthesis, such as without limitation theprosthesis1010 described above, comprising inserting a delivery catheter such ascatheter system1000 into an artery, exposing one ormore branch sheaths1024, advancing one or more angiographic catheters having one or more guidewires into the one ormore branch sheaths1024 and cannulating the target branch vessels, advancing the one ormore branch sheaths1024 over the angiographic catheters and into the target branch vessels, advancing the wall of the prosthesis adjacent to each of one or more fenestrations in the prosthesis toward the ostium of the target branch vessels, removing the one or more angiographic catheters and/or guidewires, inserting one or more branch stents into the branch vessels, retracting the branch sheaths, expanding the branch stents, and flaring a portion of the branch stents. In some arrangements, the target branch vessels are the renal arteries. Some arrangements also comprise deploying a proximal and distal portion of the prosthesis. The steps of the foregoing procedure can be performed in the sequence described, or can be performed in any suitable sequence.
• Some arrangements are directed to methods of deploying an endoluminal prosthesis, such as without limitation theprosthesis1010 described above, comprising inserting a delivery catheter such ascatheter system1000 into an artery, exposing one ormore branch sheaths1024, advancing one or more angiographic catheters having one or more guidewires into the one ormore branch sheaths1024 and cannulating the target branch vessels, advancing the one ormore branch sheaths1024 over the angiographic catheters and into the target branch vessels, deploying a proximal portion of the prosthesis, advancing the wall of the prosthesis adjacent to each of one or more fenestrations in the prosthesis toward the ostium of the target branch vessels, removing the one or more angiographic catheters and/or guidewires, inserting one or more branch stents into the branch vessels, retracting the branch sheaths, expanding the branch stents, and flaring a portion of the branch stents. In some arrangements, the target branch vessels are the renal arteries. Some arrangements also comprise deploying a proximal and distal portion of the prosthesis. The steps of the foregoing procedure can be performed in the sequence described, or can be performed in any suitable sequence.
• Some arrangements are directed to methods of deploying an endoluminal prosthesis, such as without limitation theprosthesis1010 described above, comprising advancing a delivery catheter such ascatheter system1000 into a blood vessel or artery, exposing one ormore branch sheaths1024, advancing one or more angiographic catheters into the one ormore branch sheaths1024 and cannulating the target branch vessels, and advancing the one ormore branch sheaths1024 over the angiographic catheters and into the target branch vessels. The steps of the foregoing procedure can be performed in the sequence described, or can be performed in any suitable sequence. In some embodiments, the step of advancing the one or more angiographic catheters into the one ormore branch sheaths1024 and cannulating the target branch vessels can be completed before expanding a main body portion of the prosthesis. In some embodiments, the one or more angiographic catheters can have one or more guidewires therein.
• Some arrangements are directed to methods of deploying a stent graft across at least one branch vessel, the stent graft having at least one lateral opening or fenestration formed therein and the stent graft being constrained within a delivery system having a distal and a proximal end, wherein a catheter extends from the proximal end of the delivery system through the fenestration formed in the stent graft. In some arrangements, a guidewire can be passed from the proximal end of the delivery system through the catheter and into the target branch vessel with the proximal and distal end of the stent graft remaining constrained in the delivery system.
• Some embodiments are directed to apparatuses for placing a prosthesis across at least one branch vessel, the prosthesis having a distal end, a proximal end, a midsection, and at least one lateral opening in the midsection of the prosthesis. In some embodiments, the prosthesis can be constrained in a delivery system having a distal and a proximal end. The apparatus can comprise a catheter extending from the proximal end of the delivery system through the lateral opening in the prosthesis, wherein a guidewire can be passed from the proximal end of the delivery system through the catheter, into the branch vessel with at least the proximal and distal ends of the prosthesis remaining constrained in the delivery system. In some embodiments, the prosthesis can be a stent graft.
• FIGS. 62A and 62B are perspective views of an embodiment of aprosthesis1200 comprising one or more fenestrations1202 formed in thegraft1204, and a stent orsupport member1206. The embodiment of thegraft1204 is shown in dashed lines inFIG. 62B for clarity. In some embodiments, theprosthesis1200 can have any of the features, components, or other details of any other prosthesis embodiments disclosed herein such as, without limitation,prosthesis1010 described above. Further, any of the features of the embodiment of theprosthesis1200 can be used in combination with any of the other prosthesis embodiments disclosed herein.
• In some embodiments, thegraft1204 can be supported by thestent1206 along at least a portion of thegraft1204. Further, thegraft1204 can be overlapped and can have stitching orsutures1208 along one or more edges of thegraft1204, which can improve the tear resistance of thegraft1204 and can improve the connection between thegraft1204 and thestent1206.
• Similar to other graft embodiments described herein, some embodiments of thegraft1204 can be configured to have excess or slack graft material in at least a portion thereof relative to the stent which supports the graft. For example, without limitation, the excess graft material can faun a bulge or other enlargement in thegraft1204 in the approximate location of one or more fenestrations1202 formed through the graft material. The excess or slack material along the circumference of the graft1204 (for example, without limitation, in theenlarged portion1204aof the graft1204) can allow for circumferential and/or axial movement of the graft material and, hence, the one or more fenestrations1202, relative to thestent1206 and the ostium of the patient's branch vessels. Therefore, in some embodiments, the diameter of thegraft1204 at and/or adjacent to the location of one or more fenestrations1202 can be larger than the local diameter of the target vessel. Similarly, in some embodiments, the diameter of thegraft1204 at and/or adjacent to the location of one or more fenestrations1202 can be larger than the diameter of the non-enlarged portion of the graft material. In some embodiments, without limitation, the outside surface of thegraft1204 in theenlarged portion1204aor otherwise can be free from any corrugations or other preformed folds, overlaps, or other similar pre-formed features.
• Further, similar to any of the other graft embodiments disclosed herein, thegraft1204 can have excess graft material in an axial direction, in addition to or in the alternative of the diametrically enlarged portion. The excess or slack material along the length of thegraft1204 can increase the circumferential and/or axial adjustability or movement of the graft material adjacent to the one or more fenestrations1202 formed in thegraft1204. Accordingly, in some embodiments, the length of the graft material between the proximal and distal attachment points to thestent1206 can be longer than that of thestent1206 between the proximal and distal attachment points. Or, in some embodiments, the graft material in a mid portion of thegraft1204, including on either side of theenlarged portion1204a,can have an increased length relative to the stent radially adjacent to such graft portion.
• Further, in some embodiments, the enlarged portion and/or excess length of thegraft1204 or any other graft embodiment disclosed herein can be free from any attachment points to the stent or support member which supports thegraft1204. In these configurations, the positional adjustability of the ‘fenestrations can be increased because the graft material is free to move in an axial and/or circumferential direction relative to the stent and relative to the ostium of the target branch vessels. In some embodiments, the enlarged portion and/or excess length of thegraft1204 or any other graft embodiment disclosed herein can be configured to have only a limited number of attachment points to the stent or support member which supports thegraft1204. The attachment points can be sufficiently away from the fenestration or opening so as to not substantially affect the adjustability of the fenestration. For example, without limitation, some embodiments of theprosthesis1010 can be configured such that the enlarged or slack portion of the graft has only a limited number of attachments to a stent or connector (such as connector1254) away from thefenestrations1202 so that the adjustability of the enlarged or slack portion is not significantly affected. For example, in embodiments having only one fenestration in the enlarged portion, the attachment or attachments to the stent or other support member can be positioned on an opposite side of the graft as compared to the position of the fenestration. In these configurations, the positional adjustability of the fenestrations can be increased because the graft material is substantially free to move in an axial and/or circumferential direction relative to the stent and relative to the ostium of the target branch vessels.
• With reference toFIGS. 62A-63, some embodiments of thegraft1204 can have one or moreenlarged portions1204ahaving an enlarged diameter relative to the target vessel or relative to one or more non-enlarged portions of thegraft1204, such asportions1204b,1204cthat can improve the radial and/or axial adjustability of thefenestrations1202 formed in theenlarged portions1204ato better accommodate asymmetrically positioned branch vessel ostium. In some embodiments, with reference toFIGS. 62A and 62B, thegraft1204 can have anenlarged middle portion1204ahaving one or more fenestrations1202 formed therein, a non-enlargedproximal portion1204b,and a non-enlargeddistal portion1204c.
• As discussed above, in some embodiments of theprosthesis1200, theenlarged portion1204aof thegraft1204 can have a diameter that is approximately 30% larger than a diameter of the target vessel or the diameter of thenon-enlarged portions1204b,1204cof thegraft1204. In some embodiments, the diameter of theenlarged portion1204aof thegraft1204 can be from approximately 20% or less to approximately 50% or more, or from approximately 25% to approximately 40% larger than the target vessel or the diameter of thenon-enlarged portions1204b,1204cof thegraft1204, or to or from any values within these ranges.
• Additionally, in some embodiments, theenlarged portion1204aor portion of thegraft1204 adjacent to theenlarged portion1204aof thegraft1204 can be sized and configured to be substantially longer (i.e., in the axial direction) than thestent1206, which can improve the radial and/or axial adjustability of thefenestrations1202 formed in theenlarged portions1204ato better accommodate the asymmetric and/or non-uniform positioning of branch vessel ostium. Some embodiments of thegraft1204 can be longer than thestent1206 in both theenlarged portion1204aof thegraft1204 and/or in the portion of the non-enlargeddistal portion1204cof the graft adjacent to theenlarged portion1204aof thegraft1204. For example, without limitation, theenlarged portion1204aor portion of thegraft1204 adjacent to theenlarged portion1204aof thegraft1204 can be sized and configured to be approximately 20% longer in the axial direction than thestent1206. In some embodiments, theenlarged portion1204aor portion of thegraft1204 adjacent to theenlarged portion1204aof thegraft1204 can be sized and configured to be from approximately 10% to approximately 40% or more longer in the axial direction than thestent1206.
• FIG. 63 is a top view of the embodiment of theprosthesis1200 ofFIG. 62. With reference toFIGS. 62-63, some embodiments of theprosthesis1200 can have fenestrations1202 formed in anenlarged portion1204aof thegraft1204. In some embodiments, thefenestrations1202 can be formed at non-diametrically opposed positions. This can improve the alignment of thefenestrations1202 with the ostium of the target branch vessels, which in general can be located at non-diametrically opposed positions. In some embodiments, thefenestrations1202 formed in either the enlarged portion orportions1204aornon-enlarged portions1204b,1204cof thegraft1204, can be angled away from the diametrically opposed position (represented by angle X inFIG. 63) such that thefenestrations1202 are separated by an angle (represented by angle Y inFIG. 63) that is less than 180 degrees.
• For example, without limitation, some embodiments of thegraft1204 can have twofenestrations1202 formed at an angle away from the diametrically opposed position (represented by angle X inFIG. 63) of approximately 15 degrees such that thefenestrations1202 are separated by an angle (represented by angle Y inFIG. 63) that is approximately 150 degrees. Some embodiments of thegraft1204 can have twofenestrations1202 formed at an angle away from the diametrically opposed position of between approximately 10 degrees or less and approximately 20 degrees or more, such that thefenestrations1202 are separated by an angle (represented by angle Y inFIG. 63) that is between approximately 160 degrees and approximately 140 degrees.
• Some embodiments of thegraft1204 can have twofenestrations1202 formed in anenlarged portion1204aof the graft and wherein thefenestrations1202 are separated by an angle that is less than 180 degrees, for example approximately 150 degrees. In this configuration, positioning thefenestrations1202 to be separated by an angle that is less than 180 degrees (such as, for example, approximately 150 degrees) can improve the alignment of thefenestrations1202 with the ostium of the target branch vessels such that theenlarged portion1204aof thegraft1204 can be from approximately 20% to approximately 60% greater than thenon-enlarged portion1204b,1204cof thegraft1204. In some embodiments of this configuration, theenlarged portion1204aof thegraft1204 can be from approximately 20% to approximately 40% greater than thenon-enlarged portion1204b,1204cof thegraft1204.
• Some embodiments of thegraft1204, which can be a bifurcated or other suitably configured graft, can have twofenestrations1202 formed in anenlarged portion1204aof the graft, wherein thefenestrations1202 can be separated by an angle that is less than 180 degrees, and wherein the length of at least a portion of thegraft1204 can be substantially greater than the length of thestent1206, for example approximately 10% greater than the length of thestent1206. In this configuration, positioning thefenestrations1202 to be separated by an angle that is less than 180 degrees (such as, for example, approximately 150 degrees) and increasing the length of thegraft1204 to be approximately 10% greater than the length of thestent1206 can improve the alignment/alignability of thefenestrations1202 with the ostium of the target branch vessels such that theenlarged portion1204aof thegraft1204 can be from approximately 10% or less to approximately 20% greater than thenon-enlarged portion1204b,1204cof thegraft1204.
• With reference toFIGS. 62-63, though not required, some embodiments of theprosthesis1200 can have reinforced fenestrations1202 comprising atubular member1210 inserted through thefenestration1202 and stitched to thegraft1204 with one ormore sutures1212. In this configuration, which will be described in greater detail below, thetubular member1210 can improve the tear resistance of thefenestration1202 and also improve the sealability between thefenestrations1202 and the branch grafts and stents deployed within thefenestrations1202 as well as the pull-out resistance of the branch grafts and stents within thefenestrations1202. This configuration can reduce leakage between thefenestrations1202 and the branch grafts and stents deployed within thefenestrations1202. In some embodiments, this configuration can also increase the force required to pull the branch grafts and stents deployed within thefenestrations1202 out of thefenestrations1202, thereby reducing the inadvertent axial movement of the branch grafts and stents deployed within thefenestrations1202.
• With reference toFIGS. 65-68, some embodiments of thefenestration1202 and some arrangements of methods for manufacturing thefenestrations1202 will be described.FIG. 65 is a partially exploded schematic representation of theprosthesis1200 shown inFIG. 62, andFIG. 66 is an enlargement of thefenestration1202 shown inFIG. 65, defined by curve66-66 ofFIG. 65. As shown therein, in some embodiments, thetubular member1210 can be contracted and advanced into theopenings1220 formed in thegraft1204. In some embodiments, the diameter of thetubular member1210 can be significantly greater than the diameter of theopening1220. For example, without limitation, the diameter of thetubular member1210 can be approximately 500 percent of the diameter of theopening1220, or from approximately 200 percent to approximately 800 percent of the diameter of theopening1220, from approximately 400 percent to approximately 600 percent of the diameter of theopening1220, or to or from any values within these ranges. In some embodiments, the diameter of thetubular member1210 can be approximately 10 mm, and the diameter of theopening1220 can be approximately 2 mm.
• In some embodiments, the length of thetubular member1210 can be greater than the diameter of thetubular member1210 or the diameter of thefenestration1202. In some embodiments, the length of thetubular member1210 can be from approximately 5 mm or less to approximately 25 mm or more, or from approximately 10 mm to approximately 15 mm, or to or from any values within these ranges.
• FIG. 67 is an enlarged section view of thefenestration1202 illustrated inFIG. 65, showing theend portions1210aof thetubular member1210 being pulled back against the wall of thegraft1204 surrounding theopening1220. As illustrated therein, an annularradiopaque marker1222 can be positioned around the outside surface of thetubular member1210, so thatsuch marker1222 is secured within the annular space created by folding or stretching theend portions1210aof thetubular member1210 against the wall of thegraft1204. As illustrated inFIG. 68, theend portions1210aof thetubular member1210 can thereafter be fixed to the wall of thegraft1204 using adhesive, sutures, or any other suitable fasteners, material, or technique.
• In this configuration, in some embodiments, the length of the seal zone or contact length of thefenestration1202 in the relaxed state (represented by length L inFIG. 68), before a branch stent or graft is deployed within thefenestration1202, can be significantly greater than a contact length of a conventional fenestration not having a tubular member therein. In some embodiments, the contact length L of thefenestration1202 in the relaxed state can be approximately the same as the diameter of thefenestration1202 in the unstretched state. In some embodiments, the contact length L of thefenestration1202 in the relaxed state can be from approximately 50 percent or less to approximately 150 percent of the diameter of thefenestration1202 in the unstretched state, or from approximately 80 percent or less to approximately 120 percent of the diameter of thefenestration1202 in the unstretched state.
• With reference toFIGS. 62A and 62B, although not required, some embodiments of thegraft1204 can have a scallop or cut-away1230 at aproximal end portion1204bof thegraft1204. The cut-away1230 can be sized and configured to permit unrestricted blood flow through a branch artery, such as the suprarenal and/or the celiac arteries. The size of the cut-away1230 can be based on the anatomy of a patient, or can be sized to accommodate a wide range of vessel anatomies. In some embodiments, the cut-away1230 can have a length approximately equal to the length of two stent struts, such asstent strut1246 described below. Thegraft1204 can be overlapped and havestitching1208 along an edge of the cut-away1230. In some embodiments, theprosthesis1200 can have a flared proximal end portion to increase the sealability of such end portion of theprosthesis1200.
• In some embodiments, as described above, theprosthesis1200 can have one or more radiopaque markers, such as but not limited to the annularradiopaque marker1222 surrounding at least a portion of thefenestration1202, for improved visibility under fluoroscopy during deployment. In some embodiments, any of the radiopaque markers can be formed from gold or platinum, or any suitable material. In some embodiments, any of the radiopaque markers can be formed from a suitable non-reinforcing metallic material.
• FIG. 69 is a side view of the embodiment of thestent1206 shown inFIG. 62, viewed along a line that is perpendicular to an axis projecting through a fenestration formed in the graft1204 (not shown). For clarity, the location of afenestration1202 is shown dashed lines.FIG. 70 is a side view of thestent1206, viewed along an axis projecting through a fenestration. Again, for clarity, the location of afenestration1202 is shown dashed lines.
• With reference to FIGS.64 and69-70, in some embodiments, thestent1206 can be formed from one or more wires forming a plurality ofloops1240, which can be closed loops or eyelets, bends1242, and struts1246. Some of thebends1242 can be configured to slide along a portion of the length of arespective strut1246, to improve the flexibility and bendability of thestent1206. In some embodiments, the positioning of the plurality ofloops1240 and bends1242 can be longitudinally offset or staggered to decrease the collapsed diameter of theprosthesis1200.
• In some embodiments, thestent1206 can comprise, afirst stent segment1250 formed from one or more lengths of wire, asecond stent segment1252 formed from one or more lengths of wire, and one or more connectingmembers1254 formed from one or more lengths of wire. In some embodiments, the first andsecond stent segments1250,1252 can be positioned proximally and distally relative to the location of the fenestration (shown in dashed lines) that can be formed in the graft (not illustrated) that can be supported by thestent1206. The length of thefirst stent segment1250 can be sufficient to result in an increased seal zone in the suprarenal portion of the aorta, such as a length that extends to a position adjacent to or overlapping the superior mesenteric artery and/or the celiac artery.
• In some embodiments, two connectingmembers1254 can be positioned between the first andsecond stent segments1250,1252, and can be sized and offset from one another to provide a significant gap around the position of thefenestrations1202 to increase the accessibility and adjustability of thefenestrations1202 during deployment of theprosthesis1200. As illustrated, some embodiments of the connectingmembers1254 can have four struts. Some embodiments of the connectingmembers1254 can have three or less struts, or can have five or more struts. Some embodiments of the connectingmembers1254 can have a first connectingmember1254 having fewer struts than a second connectingmember1254.
• FIGS. 71-83 are side views of additional embodiments ofprostheses1200 having one or moreenlarged portions1204bin thegrafts1204 thereof, and one or more fenestrations1202 formed in theenlarged portions1204b.In any of the embodiments shown inFIGS. 71-83, thegraft1204 can have one or moreenlarged portions1204bhaving any of the shapes or combination of shapes illustrated inFIGS. 71-83. Additionally, any of the graft embodiments shown inFIGS. 71-83 can also have excess length or slack relative to thestent1206 along any suitable portion of thegraft1204, such as without limitation in, above, and/or below theenlarged portions1204b.
• With reference toFIG. 71, the embodiment of thegraft1204 can define a curved or arcuately shapedenlarged portion1204b,having a pair of diametrically opposed fenestrations1202 formed therein. The embodiment of thegraft1204 shown inFIG. 72 can define anenlarged portion1204bhaving a generally flatouter surface1204dbetween two generally horizontally orientedsurfaces1204e.One or more fenestrations1202 can be formed through the wall of thegraft1204 in theenlarged portion1204b.The embodiment of thegraft1204 shown inFIG. 73 can define anenlarged portion1204bhaving a generally flatouter surface1204dbetween two angled ortapered surfaces1204e.One or more fenestrations1202 can be formed through the wall of thegraft1204 in theenlarged portion1204b.
• The embodiment of thegraft1204 shown inFIG. 74 can define anenlarged portion1204bhaving two angled ortapered surfaces1204eand one or more fenestrations1202 formed at the approximate juncture of theangled surfaces1204e.The juncture of theangled surfaces1204ecan otherwise form a pointed or smoothly curved surface. Any of the embodiments of theprostheses1200 illustrated inFIGS. 71-74 can, but are not required to, have a scallop or cut-away1230 at aproximal end portion1204bof thegraft1204.
• Additionally,FIGS. 75-85 illustrate some non-limiting examples of stent configurations suitable for any of the embodiments of the prostheses disclosed herein. For example, with reference toFIG. 75, in some embodiments, afirst stent1206acan be supported within aproximal portion1204bof thegraft1204, i.e., above theenlarged portion1204b.Similarly, asecond stent1206bcan be supported within adistal portion1204cof some embodiments of thegraft1204, i.e., below theenlarged portion1204b.In some embodiments, as in the embodiment illustrated inFIG. 75, the first andsecond stents1206a,1206bcan be fixed to thegraft1204 without having any stents, connectors, struts, or other support structures therebetween. In this configuration, theenlarged portion1204acan be free of any attachments points to thestent1206.
• As illustrated inFIG. 76, in some embodiments, afirst stent1206aand asecond stent1206bcan be supported within aproximal portion1204bof thegraft1204, i.e., above theenlarged portion1204b.Similarly, athird stent1206cand afourth stent1206dcan be supported within adistal portion1204cof some embodiments of thegraft1204, i.e., below theenlarged portion1204b.In some embodiments, as in the embodiment illustrated inFIG. 76, the first andsecond stents1206a,1206bcan be fixed to thegraft1204 without having any stents, connectors, struts, or other support structures therebetween. However, in some embodiments, as illustrated inFIG. 77, the first andsecond stents1206a,1206bcan have one ormore connectors1254 therebetween. Similarly, in some embodiments, as illustrated inFIG. 76, the third andfourth stents1206c,1206dcan be fixed to adistal portion1204cof thegraft1204 without having any stents, connectors, struts, or other support structures therebetween. However, in some embodiments, as illustrated inFIG. 77, the third andfourth stents1206c,1206dcan have one ormore connectors1254 therebetween. Similar to the prosthesis embodiment illustrated inFIG. 76, theenlarged portion1204aof thegraft1204 can be free from any attachment points to thestent1206.
• The embodiment of theprosthesis1200 illustrated inFIG. 78 can have one or more struts orconnectors1254 attached to one or more apices of the first andsecond struts1206a,1206b.In some embodiments, theconnectors1254 can be straight struts spanning theenlarged portion1204a.For example, without limitation, theprosthesis1200 illustrated inFIG. 78 can have fourtotal struts1254 interconnecting the first andsecond stents1206a,1206b,as illustrated. Some embodiments of theprosthesis1200, such as the embodiment of theprosthesis1200 illustrated inFIG. 79, can have eighttotal struts1254 interconnecting the first andsecond stents1206a,1206b,as illustrated, or any suitable number ofstruts1254. Theprostheses1200 illustrated inFIGS. 78 and 79 can be configured such that the graft material in theenlarged portion1204ais free from any attachment to thestents1206 or theconnectors1254.
• In some embodiments, the connectors or struts1254 can be generally straight, as illustrated inFIGS. 78-79. However, in some embodiments, thestruts1254 can have one ormore bends1256 therein. Thebends1256 can decrease the stiffness of thestruts1254 so that thestruts1254 are more flexible in both the axial direction and also when theprosthesis1200 is bent.
• In some arrangements, the end portions of theconnectors1254 can be fixed to the apices ofadjacent stents1206, or can be slidingly supported by the struts of thestents1206. Further, in some embodiments, the end portions of theconnectors1254 can be supported at offset apex positions, as illustrated inFIG. 80. Additionally, as mentioned, any of the embodiments disclosed herein can be configured such that theenlarged portion1204acan be free of any attachments points to thestent1206, or such that theenlarged portion1204ahas a minimal number of attachments points to thestent1206.
• With reference toFIGS. 81-83, which are side views of several additional embodiments ofprostheses1200, one or more of theprostheses1200 can have asymmetrically positionedenlarged portions1204a′ formed in thegrafts1204 thereof. Such configurations may be suitable for, for example and without limitation, the thoracic artery. With reference toFIG. 81, the embodiment of theprosthesis1200 illustrated therein can have a first asymmetricenlarged portion1204a′ and a second asymmetricenlarged portion1204a″ formed therein. Some embodiments of the prostheses disclosed herein can have a third asymmetricenlarged portion1204a′″ faulted therein (not illustrated), or any number or combination of symmetrical and asymmetric enlarged portions formed therein.
• In some embodiments, theprosthesis1200 illustrated inFIG. 81 can have afirst stent1206apositioned at a first end portion of thegraft1204, asecond stent1206bpositioned at a second end portion of thegraft1204, and athird stent1206cpositioned between the asymmetricenlarged portions1204a′,1204a″. However, in some embodiments, as illustrated inFIG. 82, the graft material can be radially unsupported between the first and second asymmetricenlarged portions1204a′,1204a″, and also in the asymmetricenlarged portions1204a′,1204a″. As illustrated inFIG. 83, first and second asymmetricenlarged portions1204a′,1204a″ can be formed at any desired axial and/or circumferential position on thegraft1204. Any of the embodiments disclosed herein can have one ormore connectors1254 between any of the stents or stent segments.
• With reference toFIGS. 84-85, some embodiments of theprostheses1200 or any prostheses disclosed herein can have end portions configured for anastomotic connection with one or more blood vessels of a patient's body. As illustrated, the embodiments of theprostheses1200 illustrated inFIGS. 84 and 85 can have any number and/or combination of symmetric or asymmetricenlarged regions1204a,and any suitable number or configuration ofstents1206 within thegrafts1204. Further, theanastomotic end portions1260 can be supported by thegraft1204 and can have any suitable size or shape for the desired anastomosis.
• In some embodiments, theanastomotic end portion1260 can be made from ePTFE graft material or woven or knitted graft material. The length of theanastomtoic end portions1260 can be more than 2 cm long and as long as 20 cm to allow trimming of the end portions by the physician to accommodate the specific anatomy of the patient. In this configuration, theprostheses1200 can be suitable for hybrid procedures in which one end of the prosthesis (for example, the anastomotic end portion1260) is sewn surgically to the blood vessel and the other end is secured by a stent inside the lumen of the blood vessel.
• Some embodiments of thegraft1204 and/or thetubular members1210, or any other graft embodiments disclosed herein, can be formed from a bi-directionally expanded, layered PTFE material that can have improved tear resistance. In some embodiments, thegraft1204 can be formed from at least two layers of a bi-directionally expanded PTFE material, wherein the preferred or likely tear direction in a first layer of the material is different than the preferred or likely tear direction in a second layer of the material. Some embodiments of thegraft1204 and/or thetubular members1210, or any other graft embodiments disclosed herein, can be formed from polyurethane or any other suitable material, polymeric or otherwise.
• Additionally, any of the stent embodiments disclosed herein, including but not limited to the embodiments of thestent1206 and/or any branch stent embodiments, can be self-expanding, balloon expandable, or otherwise, and can be formed by any suitable process. For example, without limitation, some embodiments of the stents disclosed herein can be laser cut from a tube of suitable material, such as Nitinol, stainless steel, or otherwise. Additionally, any of the stent embodiments disclosed herein can be formed as described in U.S. Pat. No. 6,077,296 or U.S. Pat. No. 7,520,895, which patents are hereby incorporated by reference in their entireties as if fully set forth herein.
• FIG. 86 illustrates calculations regarding the theoretical axial adjustability of at least some embodiments of the grafts disclosed herein.FIG. 87 illustrates calculations regarding the theoretical angular or radial adjustability of at least some embodiments of the grafts disclosed herein.
• While the above detailed description has shown, described, and pointed out novel features as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the device or process illustrated can be made without departing from the spirit of the disclosure. Additionally, the various features and processes described above can be used independently of one another, or can be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of this disclosure.
• As will be recognized, certain embodiments described herein can be embodied within a form that does not provide all of the features and benefits set forth herein, as some features can be used or practiced separately from others. The scope of the inventions is indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
• For example, while some embodiments of the delivery and graft systems are described herein with respect to the abdominal aortic artery, the delivery and graft systems can be used for repairing vasculature in other portions of the body, including but not limited to the SMA, the thoracic artery, the inferior mesenteric artery, or any other arteries or blood vessels in the body suitable for such procedures or apparatuses.

Claims (35)

1. An endoluminal prosthesis, comprising:

a first stent portion and a second stent portion;

a main graft body comprising a first portion, a second portion, and a third portion, the second portion having a cross-sectional size that is significantly larger than a cross-sectional size of the first portion or the third portion, and also significantly larger than a cross-sectional size of the target vessel; and

one or more openings formed in the second portion of the main graft body;

wherein:

the first portion of the main graft body is attached to the first stent portion and wherein the third portion of the main graft body is attached to the second stent portion; and

the second portion of the main graft body is not directly attached to the first stent portion, the second stent portion, or any other internal support structure.

2. The endoluminal prosthesis ofclaim 1, wherein the cross-sectional size of the second portion is approximately 30% larger than the cross-sectional size of the target vessel.

3. The endoluminal prosthesis ofclaim 1, wherein the cross-sectional size of the second portion is from approximately 20% to approximately 40% larger than the cross-sectional size of the target vessel.

4. The endoluminal prosthesis ofclaim 1, wherein the main graft body comprises two openings formed in the second portion of the main graft body.

5. The endoluminal prosthesis ofclaim 1, wherein two openings are formed in the second portion of the main graft body, the two openings being separated by an angle between approximately 130 degrees and approximately 170 degrees.

6. The endoluminal prosthesis ofclaim 5, wherein the two openings are separated by approximately 150 degrees.

7. The endoluminal prosthesis ofclaim 1, wherein the main the first portion of the main graft body defines a generally tubular shape.

8. The endoluminal prosthesis ofclaim 1, wherein the main graft body comprises one or more cutouts in the first portion thereof.

9. The endoluminal prosthesis ofclaim 1, further comprising a branch graft supported by the main graft body and advanced through one of the openings.

10. The endoluminal prosthesis ofclaim 9, further comprising a bare or covered stent advanceable through the branch graft.

11. The endoluminal prosthesis ofclaim 1, wherein the main graft body is bifurcated.

12. The endoluminal prosthesis system ofclaim 1, wherein the main graft body is formed from a bi-directionally expanded, layered PTFE material.

13. The endoluminal prosthesis ofclaim 1, wherein the main graft body further comprises at least one radiopaque suture or marker attached thereto.

14. The endoluminal prosthesis ofclaim 1, wherein the second portion is located between the first and third portions.

15. The endoluminal prosthesis ofclaim 1, wherein the first and second stent portions are interconnected by one or more connectors spanning at least the second portion of the graft.

16. The endoluminal prosthesis ofclaim 15, wherein the end portions of the one or more connectors are slidably supported by the first and second stent portions.

17. The endoluminal prosthesis ofclaim 1, wherein a distance between end portions of the main graft body is greater than a distance between opposing end portions of the first stent portion and the second stent portion.

18. An endoluminal prosthesis, comprising:

a main graft body comprising a first portion, a second portion, and a third portion, the second portion having a cross-sectional size that is significantly larger than a cross-sectional size of the first portion or the third portion, and also significantly larger than a cross-sectional size of the target vessel; and

one or more openings formed in the second portion of the main graft body;

wherein:

the first portion of the main graft body is radially supported by a first support member;

the third portion of the main graft body is radially supported by a second support member; and

the second portion of the main graft body is free of radial support from a stent or other prosthetic device.

19. The endoluminal prosthesis ofclaim 18, wherein the first and second support members are connected by generally axially oriented struts.

20. The endoluminal prosthesis ofclaim 19, wherein the second portion of the main graft body has no attachment points to the support members or struts.

21. An endoluminal prosthesis, comprising:

a main graft body comprising a first portion, a second portion, and a third portion, the entirety of the second portion having a cross-sectional size that is significantly larger than a cross-sectional size of the first portion or the third portion, and also significantly larger than a cross-sectional size of the target vessel;

a support member positioned within the main graft body, the support member having a first support portion, a second support portion, and a third support portion; and

one or more openings formed in the second portion of the main graft body;

wherein:

the first portion of the main graft body is attached to the first support portion of the support member at a first number of attachment points;

the second portion of the main graft body is attached to the second support portion of the support member at a second number of attachment points;

the third portion of the main graft body is attached to the third support portion of the support member at a third number of attachment points; and

the third number of attachment points is less than the first number of attachment points and the third number of attachment points.

22. The endoluminal prosthesis ofclaim 21, wherein the second support portion comprises one or more connecting members that connect the first and third support portions, and the second portion of the main graft body is attached to the connecting members.

23. The endoluminal prosthesis ofclaim 21, wherein the cross-sectional size of the second portion is from approximately 20% to approximately 40% larger than the cross-sectional size of the target vessel.

24. The endoluminal prosthesis ofclaim 21, wherein two openings are formed in the second portion of the main graft body, the two openings being separated by an angle between approximately 130 degrees and approximately 170 degrees.

25. The endoluminal prosthesis ofclaim 21, wherein the second portion is located between the first and third portions.

26. The endoluminal prosthesis ofclaim 21, wherein a distance between end portions of the main graft body is greater than a distance between opposing end portions of the first support portion and the second support portion.

27. A method of deploying an endoluminal prosthesis, comprising:

advancing a catheter supporting the endoluminal prosthesis therein through a patient's vasculature to a target vessel location, wherein:

the prosthesis has a main graft body comprising a first portion, a second portion, and a third portion; and

the second portion of the main graft body has a cross-sectional size that is significantly larger than a cross-sectional size of the first portion and the third portion, and also significantly larger than a cross-sectional size of the target vessel;

advancing one or more catheters through one or more fenestrations formed in the main graft body and into one or more branch vessels in the patient's vasculature;

at least partially expanding at least the second portion of the main graft body; and

substantially aligning the one or more fenestrations formed within the second portion of the main graft body with the one or more branch vessels by moving the one or more fenestrations in a circumferential and/or axial direction toward an ostium of the one or more branch vessels.

28. The method of deploying an endoluminal prosthesis ofclaim 27, wherein at least partially expanding at least a portion of the prosthesis comprises removing a radial restraint surrounding the prosthesis and permitting the prosthesis to self-expand.

29. The method of deploying an endoluminal prosthesis ofclaim 27, wherein the first portion of the main graft body is attached to the first stent portion and wherein the third portion of the main graft body is attached to the second stent portion; and the second portion of the main graft body is not directly attached to the first stent portion, the second stent portion, or any other internal support structure.

30. The method of deploying an endoluminal prosthesis ofclaim 27, wherein the cross-sectional size of the second portion is approximately 30% larger than the cross-sectional size of the target vessel.

31. The method of deploying an endoluminal prosthesis ofclaim 27, wherein the cross-sectional size of the second portion is from approximately 20% to approximately 40% larger than the cross-sectional size of the target vessel.

32. The method of deploying an endoluminal prosthesis ofclaim 27, wherein two openings are formed in the second portion of the main graft body, the two openings being separated by an angle between approximately 130 degrees and approximately 170 degrees.

33. The method of deploying an endoluminal prosthesis ofclaim 32, wherein the two openings are separated by approximately 150 degrees.

34. The method of deploying an endoluminal prosthesis ofclaim 27, further comprising advancing a bare or covered stent through the one or more fenestrations.

35. The method of deploying an endoluminal prosthesis ofclaim 27, wherein the first and second stent portions are interconnected by one or more connectors spanning at least the second portion of the graft.

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