US20120109279A1 - Apparatus and method of placement of a graft or graft system - Google Patents

Abstract

A fenestrated graft deployment system, with a delivery catheter having a catheter body, An endoluminal prosthesis having a main graft body, the main graft body having a lumen therethrough and a first opening laterally through a wall of the main graft body. A first guidewire prepositioned within the delivery catheter extending through at least a portion of the catheter body into a main lumen of the endoluminal prosthesis and through the first opening in the wall of the prosthesis when the delivery catheter is in a predeployed configuration. A first fenestration alignment device is configured to extend through at least a portion of the delivery catheter and is configured to be axially moveable relative to the first guidewire. The first fenestration alignment device has an end portion having an outside perimeter configured such that when an end portion of the fenestration alignment device moves toward the first opening of said main graft body the outside perimeter of the first opening is smaller than the outside perimeter of the first fenestration alignment device and prevents it from passing through the first opening and causes the main graft body adjacent to the first opening to move with the end of the first fenestration alignment device to act as alignment tool to allow an operator to align the first opening in the side of the endoluminal prosthesis with an ostium of a target branch vessel into which said first opening is to extend and act as a guide and seal for a subsequently delivered branch graft endoluminal prosthesis.

Description

PRIORITY INFORMATION AND INCORPORATION BY REFERENCE
• This application claims priority benefit of U.S. Provisional Application 61/409,504 (titled “APPARATUS AND METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM”), filed Nov. 2, 2010, which application is hereby incorporated by reference in its entirety as if fully set forth herein. The benefit of priority is claimed under the appropriate legal basis including, without limitation, under 35 U.S.C. §119(e). Additionally, U.S. patent application Ser. No. 12/769,506, filed on Apr. 28, 2010 (entitled “APPARATUS AND METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM”) is also hereby incorporated by reference in its entirety as if fully set forth herein.
BACKGROUND OF THE DISCLOSURE
• 1. Technical Field
• Endoluminal vascular prostheses delivery devices and methods of deploying such prostheses for use in the treatment of aneurysms at branches of arterial vessels, in particular the aorta, are described.
• 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.
• 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 or stent 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.
• Prior branch graft arrangements are complex and require many steps of insertion and removal to orient and align fenestrations in a main body to the surrounding anatomy and still more steps to insert, deploy, and seal a branch graft (covered stent) to the main stent graft body and to the wall of the branch vessel without unacceptable leakage.
• Thus, there is a need to simplify the delivery of branch graft devices to provide improved reliability and reduced procedure duration.
SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS
• Designs and methods of placement of a branch graft or branch graft system having lateral openings in the main graft are disclosed. The main graft is 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. The positions of the branch blood vessels can vary from one patient's anatomy to the next, the graft systems disclosed herein allow a surgeon to adjust the position of the fenestrations in the main body so as to align them with the branch vessels to improve the efficiency of branch graft deployment.
• 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. 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.
• 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 a portion of the main graft can provide excess or slack graft material in the main graft to allow the fenestrations to each be moved in one or a combination of lateral, axial and angular directions so that the fenestrations can be aligned with the branch arteries.
• One or more branch grafts can be supported by the main graft body adjacent to the one or more fenestrations (openings) that can be formed in the main graft body. A compressed branch graft is small enough to allow it 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, or by the removal of a surrounding restraint in the case of a self-expanding device.
• Some embodiments relate to a fenestrated graft deployment system, comprising a delivery catheter having a catheter body, a prosthesis having a main graft body, the main graft body having lumen therethrough and a first opening laterally through a wall of the main graft body, a first guidewire prepositioned within the delivery catheter extending through at least a portion of the catheter body into a main lumen of the endoluminal prosthesis and through the first opening in the wall of the prosthesis when the delivery catheter is in a predeployment state. The system can have a first fenestration alignment device extending through at least a portion of the delivery catheter configured to be axially moveable relative to the first guidewire. The first fenestration alignment device can be configured such that a portion of the fenestration alignment device contacts the main graft body adjacent to the first opening to approximately align the first fenestration with an ostium of a target branch vessel when advanced relative to the fenestration.
• Some embodiments relate to a fenestration push device for use in a fenestrated prostheses deployment catheter, comprising a body portion defining a lumen therethrough, the lumen having a first diameter or cross-sectional size or perimeter, and a protrusion supported at or adjacent to a distal end of the body portion, the protrusion projecting away from an outside surface of the body portion and defining a second cross-sectional or perimeter size. The second cross-sectional size of the fenestration push device at the location of the protrusion is greater than the first diameter or size of the body portion. Additionally, the second cross-sectional size of the protrusion is greater than a cross-sectional size of a fenestration formed in a respective fenestrated graft.
• Some embodiments relate to method of deploying a fenestrated endoluminal prosthesis in a patient's vasculature, 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 opening through a wall thereof, advancing a first guide sheath through the first opening and into a first branch vessel, and advancing a first fenestration alignment device into contact with the prosthesis adjacent to the first opening through the wall of the prosthesis so as to approximately align the first opening with an ostium of the first branch 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 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 the ostium of the one or more branch vessels. In any of the embodiments or arrangements disclosed herein, the prosthesis can have a main graft body comprising a first portion, a second portion, and a third portion. 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.
• 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. 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. 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.
• Some embodiments or arrangements are directed to methods of 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 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 by advancing one or more alignment devices relative to the one or more fenestrations, engaging such fenestrations with the one or more alignment devices, and aligning such fenestrations with the one or more branch vessels. The prosthesis can have a main graft body which can have a first portion, a second portion, and a third portion, and 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 of 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, exposing at least one branch sheath, the branch 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 main graft body, advancing an angiographic catheter into the branch sheath and cannulating a first target branch vessel before expanding the main graft body of the prosthesis, engaging the main graft body adjacent to the first opening, and advancing the main graft body adjacent to the first opening into approximate alignment with an ostium of the target branch blood vessel.
• 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 sectional view of a patient's vasculature illustrating an endoluminal prosthesis deployed in 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 endoluminal prosthesis deployed in the patient's anatomy, taken at3-3 inFIG. 1, before the fenestrations have been aligned with the respective branch vessels.
• FIG. 4 is a cross-sectional view of the endoluminal prosthesis deployed in the patient's anatomy, taken at3-3 inFIG. 1, after the fenestrations have been aligned with the respective branch vessels.
• FIG. 5A is a side view of a catheter system comprising an introducer catheter and a delivery catheter.
• FIG. 5B is an oblique view of a catheter system illustrated inFIG. 5A, showing the outer sheath in a partially retracted position.
• FIG. 6 is an oblique view of introducer catheter shown inFIGS. 5A and 5B.
• FIG. 7 is an exploded view the introducer catheter shown inFIGS. 5A and 5B.
• FIG. 8 is a close up view the delivery catheter shown inFIGS. 5A and 5B.
• FIG. 9 is an exploded view the delivery catheter shown inFIG. 5A.
• FIG. 10 is a sectional view of a portion10-10 of delivery catheter shown inFIG. 5A.
• FIG. 11A is a sectional view of the delivery catheter shown inFIGS. 5A and 5B, taken at11A-11A inFIG. 10.
• FIG. 11B is a sectional view the delivery catheter shown inFIGS. 5A and 5B, taken at11B-11B inFIG. 10.
• FIG. 12 is a side view the catheter system shown inFIG. 5B, showing the outer sheath in a partially retracted position.
• FIG. 13 is an close up side view of the portion13-13 of the catheter system shown inFIG. 12, showing the outer sheath in a partially retracted position.
• FIG. 14 is an close up side view of the portion14-14 of the catheter system shown inFIG. 12, showing the outer sheath in a partially retracted position and the proximal sheath in a partially advanced position.
• FIG. 15 is a side view the catheter system shown inFIGS. 5A and 5B, showing the outer sheath in a partially retracted position and one branch sheath and one fenestration alignment component in a partially advanced position.
• FIG. 16 is a sectional view of a portion of a patient's vasculature, showing the delivery catheter ofFIG. 5A being advanced through a patient's abdominal aorta.
• FIG. 17 is a sectional view of a portion of a patient's vasculature, showing the delivery catheter ofFIG. 5A and an angiographic catheter being advanced through a branch sheath of the delivery catheter toward a branch vessel.
• FIG. 18 is a sectional view of a portion of a patient's vasculature, showing the delivery catheter illustrated inFIG. 5A and the branch sheaths of the delivery catheter being advanced into a patient's branch arteries.
• FIG. 19 is a sectional view of a portion of a patient's vasculature, showing a distal sheath of the delivery catheter illustrated inFIG. 5A being advanced to deploy a proximal portion of the prosthesis.
• FIG. 20 is a sectional view of a portion of a patient's vasculature, showing a peelable sheath of the delivery catheter illustrated inFIG. 5A being removed to deploy a distal portion of the prosthesis.
• FIG. 21 is a sectional view of a portion of a patient's vasculature, showing a fenestration alignment component of the delivery catheter illustrated inFIG. 5A advancing an inner wall of the prosthesis adjacent to a fenestration toward an ostium of the target branch vessel.
• FIG. 22 is a sectional view of a portion of a patient's vasculature, showing a branch stent being advanced into the target branch vessel.
• FIG. 23 is a sectional view of a portion of a patient's vasculature, showing the branch stent ofFIG. 22 being expanded in the target branch vessel and flared.
• FIGS. 24A and 24B are oblique views of a prosthesis having one or more fenestrations therein, the graft being shown in dashed lines inFIG. 24B for clarity.
• FIG. 25 is a top view of the prosthesis ofFIG. 24.
• FIG. 26 is an enlarged view of a portion of the prosthesis ofFIG. 24, defined by curve26-26 ofFIG. 24B.
• FIG. 27 is a side view of the stent shown inFIG. 24, perpendicular to an axis projecting through the fenestration.
• FIG. 28 is a side view of the stent shown inFIG. 24, along an axis projecting through the fenestration.
• FIG. 29 is an oblique view of a fenestration alignment component, which is also referred to herein as a fenestration alignment component.
• FIG. 30 is a side view of the fenestration alignment component illustrated inFIG. 29.
• FIG. 31A is an end view of the fenestration alignment component illustrated inFIG. 29.
• FIG. 31B is a sectional view through a portion of the fenestration alignment component, taken at31B-31B ofFIG. 31A.
• FIG. 32 is an oblique view of a delivery catheter having the fenestration alignment component ofFIG. 29.
• FIG. 33 is an exploded view of the delivery catheter shown inFIG. 32.
• FIG. 34 is a sectional view of a portion of a patient's vasculature, showing the fenestration alignment component illustrated inFIG. 29 advancing an inner wall of the prosthesis adjacent to a fenestration toward an ostium of the target branch vessel.
• FIG. 35 is a sectional view of a portion of a patient's vasculature, showing a branch stent being advanced into the target branch vessel while the fenestration alignment component illustrated inFIG. 29 can be used to maintain the inner wall of the prosthesis adjacent to a fenestration in the prosthesis in the desired position relative to the ostium of the target branch vessel.
DETAILED DESCRIPTION
• 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.
• 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. 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. 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 (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, 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, 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. 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, 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, 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.
• FIG. 1 is a partial cross sectional view of a patient's vasculature illustrating an endoluminal prosthesis deployed in the desired position within the patient's vasculature.
• As an example,FIG. 1 shows an endoluminal prosthesis deployed in a patient'saorta10. Ananeurysmal 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. theendoluminal prosthesis20 illustrated inFIGS. 1 and 2 has amain graft body22, afirst fenestration24, and asecond fenestration26. The main graft is a bifurcated graft having a firstbifurcated branch28 and a secondbifurcated branch30 for placement in the ipsilateral and contralateral iliac arteries.
• Themain graft body22 has a generally cylindrical, tubular shape. Theendoluminal prosthesis20 can be formed from any suitable material, such as, but not limited to, ePTFE. Theendoluminal prosthesis20 is formed from an expandable material. Theendoluminal prosthesis20 is formed such that themain graft body22 can be sized to be 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. 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, 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 in diameter. Therefore, the diameter of themain graft body22 can be approximately 8 mm larger than the diameter of the target vessel. 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, rotational, or angular direction, or a combination thereof 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, anadditional fenestration32 can be formed in a distal portion of themain graft body22. Thefenestration32 can be formed so as to align with a patient's SMA
• FIG. 3 is a cross-sectional view of theendoluminal prosthesis20 deployed in the patient's anatomy, taken at3-3 inFIG. 1, as it might appear before thefenestrations24,26 have become 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. 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.
• 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). 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 theendoluminal prosthesis20 deployed in the patient's anatomy, taken at3-3 inFIG. 1, after thefenestrations24,26 have become aligned with the respective branch vessels. With reference toFIG. 4, the oversizedmain graft body22 is aligned with the patient's anatomy by thefenestration24 following a angiographic or guide catheter over which it is threaded to align with the respective branch vessel as the main body is deployed, but after the branch vessel guidewires are positioned in the branch vessels. For example, thefenestration24 as it moves closer to thefenestration26, causes a gathering of 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). 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 more axial springs can be anchored to the main graft body to provide axial or column strength to the main graft body. The springs can have a helical shape, as illustrated, and can have any suitable size, length, pitch, or diameter. However, such helical shape is not required. The springs can have any suitable shape, including a straight, flat, round, or non-round shape. The springs can be formed from any suitable biocompatible material, such as without limitation stainless steel, Nitinol, or suitable metallic or polymeric materials.
• 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, U.S. patent application Ser. No. 12/101,863, filed on Apr. 11, 2008, entitled BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS, and U.S. Provisional Application 61/409,504, entitled APPARATUS AND METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM, filed Nov. 2, 2010, 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. 5A is a side view of acatheter system1000 comprising an introducer catheter1002 (also referred to as an introducer) and 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.
• FIG. 5B is an oblique view of acatheter system1000 illustrated inFIG. 5A, showing anouter sheath1006 of thedelivery catheter1004 in a partially retracted position. With reference toFIGS. 5A and 5B, theouter sheath1006 can be used to constrain at least a portion of aprosthesis1010. 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.
• As illustrated inFIG. 5B, 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 (connected to) adistal tip1014 of thecatheter system1000. 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. 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 causes thedistal sheath1012 to advance 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, portions of the prosthesis axially adjacent to enlarged graft portions of the prosthesis, can be configured to be self-expanding.
• Theinner core1020 can be slidably received within theouter sheath1006 of thedelivery catheter1004. 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.
• 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, fenestration alignment components (also referred to herein as fenestration alignment components), 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. Theinner core1020 can be configured to accommodate the insertion of such sheath members, fenestration alignment components, 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. 5B, at least a portion of theprosthesis1010 supported by thecatheter system1000 can be exposed and, potentially, deployed. 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, theprosthesis1010 can be configured to have radially self-expanding support members therein along only a portion or portions of theprosthesis1010. For example, a graft of theprosthesis1010 can be radially unsupported at or adjacent to fenestrations formed in the graft. Alternatively, 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.
• Thedelivery catheter1004 can also have one or more branch or guidesheaths1024 supported thereby. 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 slidably 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, 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 (compressed) 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. 5A-5B, 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. 5B, although not required, thedelivery catheter1004 can have one or morefenestration alignment components1026 supported thereby. The one or morefenestration alignment components1026 can be slidably received within one ormore lumen1027 formed in theinner core1020. The one or morefenestration alignment components1026 can each have anend portion1026athat can be sized and configured to surround an outer surface of each of thebranch sheaths1024. Theend portion1026aof eachfenestration alignment component1026 can have, 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 thefenestration alignment component1026 over thebranch sheaths1024 such that theend portion1026aof eachfenestration alignment component1026 contacts the edge or surface adjacent to and surrounding 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 or morefenestration alignment components1026 is configured to be slidably supported within a lumen formed in theinner core1020 so that each of the one or morefenestration alignment components1026 can be axially advanced relative to theinner core1020. Further, thedelivery catheter1004 can be configured such that thefenestration alignment components1026 can be axially or rotationally adjusted or twisted relative to theinner core1020, for increased maneuverability of thefenestration alignment components1026.
• In some embodiments, eachfenestration alignment component1026 can be positioned within thedelivery catheter1004 such that, in the loaded configuration wherein aprosthesis1010 is supported (compressed) within thedelivery catheter1004, eachfenestration alignment component1026 is pre-positioned so that theend portion1026aof eachfenestration alignment component1026 is positioned distal to the end portion of theinner core1020. In the loaded configuration, eachfenestration alignment component1026 can be positioned such that theend portion1026aof eachfenestration alignment component1026 is located within the main lumen of the main body of theprosthesis1010.
• Thebranch sheaths1024 andfenestration alignment components1026 can have any suitable size and can be made from any suitable material. For example, 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. Thefenestration alignment components1026 can be formed from stainless steel, Nitinol, or any other suitable metallic or non-metallic material, and can have a thickness suitable to prevent thefenestration alignment components1026 from buckling when axially advanced against a portion of theprosthesis1010. For example, thefenestration alignment components1026 can have an approximately 1 Fr diameter, or between approximately a 1 Fr and approximately a 4 Fr diameter. Further, the fenestration alignment component 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, 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. 6 and 7 are oblique and exploded views, respectively, of theintroducer catheter1002 shown inFIG. 5A. 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. 6-7, theintroducer1002 can have amain body1030, a threadablyengageable hub 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 threadably 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.
• 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. 8 and 9 are oblique and exploded views, respectively of thedelivery catheter1004 shown inFIG. 5A.FIG. 10 is a sectional view of a portion10-10 of thedelivery catheter1004 shown inFIG. 5A.FIG. 11A is a sectional view of thedelivery catheter1004 shown inFIG. 5A, taken at11A-11A shown inFIG. 10.FIG. 11B is a sectional view of thedelivery catheter1004 shown inFIG. 5A, taken at11B-11B shown inFIG. 10.
• As shown therein, 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 or morefenestration alignment components1026. Theaccess ports1052,1054 can be configured to sealingly tighten around thebranch sheaths1024 or thefenestration alignment components1026, and to constrict around thebranch sheaths1024 or thefenestration alignment components1026 so as to substantially axially secure thebranch sheaths1024 or thefenestration alignment components1026. Asealable cap assembly1051 can be threadably 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.
• 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. 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. The one ormore tab members1074 can have a generally flat, plate-like shape, such as is illustrated inFIG. 8. The one ormore tab members1074 can be formed from a suitable polymeric or metallic material. 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.
• The one ormore tab members1074 can be similar to any of the embodiments of the torsion tab (such as 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. 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. The one ormore tabs1074 can engage a stent or other portion of an endoskeleton of theprosthesis1010, or, can engage the material of thegraft1204 surrounding thetab member1074 so that theprosthesis1010 can substantially rotate with theinner core1020 of thedeployment catheter1004.
• FIG. 12 is a side view of thecatheter system1000 showing theouter sheath1006 in a partially retracted position, similar to the configuration shown inFIG. 5B.FIG. 13 is an enlarged side view of the portion13-13 of the catheter system shown inFIG. 12.
• With reference toFIG. 13, 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. 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. Therelease wire1062 can be slidably 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, 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 (not illustrated). 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. 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.
• Theprosthesis1010 can have one ormore openings1011 formed therein. For example and the fenestrations oropenings1011 can be formed in theprosthesis1010 at diametrically opposing positions. As will be described in greater detail below, one or more of theopenings1011 can be formed in theprosthesis1010 at a position that is angularly offset from the diametrically opposing position. Similarly, when used, thesheath1060 can have one ormore openings1061 formed therein, theopenings1061 being positioned adjacent to the similar number ofopenings1011 formed in the prosthesis. 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. 11B, due to the non-uniform design of the stent within the graft material, 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 bidirectionally expanded, layered PTFE material have thin walls to further increase the space efficiency of theprosthesis1010.
• As illustrated inFIG. 13, 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. 14, thecatheter system1000 can be configured to only have onerelease wire1062 threadably advanced through thesheath1060.FIG. 14 is an enlarged side view of thecatheter system1000 shown inFIG. 5A, defined by curve14-14 shown inFIG. 12, showing theouter sheath1006 in a partially retracted position and thedistal sheath1012 in a partially advanced position.
• 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. As illustrated inFIG. 14, 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. 14, 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. 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. Theproximal portion1010bof theprosthesis1010 can be deployed in this manner before thedistal portion1010aof theprosthesis1010 is deployed, or simultaneously with the deployment of thedistal portion1010aof theprosthesis1010. Theproximal portion1010bof theprosthesis1010 can be deployed in this manner after thedistal portion1010aof theprosthesis1010 is deployed.
• FIG. 15 is a side view of thecatheter system1000 shown inFIG. 5A, showing theouter sheath1006 in a partially retracted position and onebranch sheath1024′ and onefenestration alignment component1026′ 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. 15 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 thefenestration alignment components1026′,1026″ can be advanced relative to thebranch sheaths1024′,1024″ by advancing the respectivefenestration alignment component1026 through therespective access port1054. For example, thefenestration alignment component1026′ can be advanced by advancing the proximal portion of thefenestration alignment component1026′ in the direction of arrow A2 inFIG. 15.
• 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. 16-23.FIG. 16 is a sectional 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. 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. 17 is a sectional 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. 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.
• 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, the mid portion of theprosthesis1010 radially adjacent to the one or more fenestrations1011 can be unsupported by anystents1254. In 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, 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.
• Theangiographic catheter1065 can be configured such that an end portion thereof is biased to have a curved disposition (shape), as is well known in the art.
• As shown, anangiographic catheter1065 is being advanced relative to thebranch sheath1024aand into the target branch vessel, in this case a renal artery. 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. 18. 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. 19, aproximal portion1010bof theprosthesis1010 can be deployed by axially advancing thedistal sheath1012 relative to theinner core1020 and theprosthesis1010. 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. 20 is a sectional view of a portion of a patient's vasculature, showing apeelable sheath1060 being removed from thedistal portion1010aof theprosthesis1010 so as to deploy adistal portion1010aof theprosthesis1010. 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, 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.
• As illustrated, adistal portion1060aof thesheath1060 can be torn by therelease wire1062 before aproximal portion1060bof thesheath1060 is torn by the release wire so that aproximal portion1010bof the prosthesis (i.e., adjacent to theproximal portion1060aof the sheath1060) can be deployed before adistal portion1010aof thesheath1010. Aproximal portion1060bor a middle portion of thesheath1060 can be torn by therelease wire1062 before adistal portion1060aof thesheath1060 is torn by the release wire (not illustrated). 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 portion1010aof 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. 20. However, 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, theprosthesis1010 can be a bifurcated prosthesis.
• FIG. 21 is a sectional view of a portion of a patient's vasculature, showing afenestration alignment component1026 contacting and pushing an inner wall of theprosthesis1010 adjacent to afenestration1011 toward an ostium of the target branch vessel. As illustrated, thefenestration alignment component1026 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. Thecatheter system1000 can be configured to not have afenestration alignment component1026, and can accordingly be configured to deploy a fenestrated graft without the use of such a component
• As illustrated inFIG. 22, 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. 23. Theinflation balloon1086 can be configured to expand and flare a portion of thestent1084 within or to the inside of thefenestration1011 formed in the prosthesis.
• Thefenestration alignment component1026 described above can be configured to be supported within a renal or branch stent delivery catheter. For example, thefenestration alignment component1026 can be configured to be supported within a modified renal stent catheter, such as the renal stent catheter illustrated inFIG. 22. Thefenestration alignment component1026 can be configured to only partially surround thebranch sheath1024 or the branch stent delivery catheter. In this configuration, thefenestration alignment component1026 can be configured to be entirely positioned within and advanceable through a lumen of thebranch sheath1024 or the branch stent delivery catheter. For example, thefenestration alignment component1026 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, 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, 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.
• Thefenestration1011 in theprosthesis1010 can expand as thebranch stent1084 is being expanded, to improve the seal between thefenestration1011 and thebranch stent1084. 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 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.
• 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. 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. The prosthesis can be a stent graft.
• FIGS. 24A and 24B are oblique views of aprosthesis1200 comprising one or more fenestrations1202 formed in thegraft1204, and a stent orsupport member1206. thegraft1204 is shown in dashed lines inFIG. 24B for clarity. Theprosthesis1200 can have any of the features, components, or other details of any other prosthesis embodiments disclosed herein such as,prosthesis1010 described above. Further, any of the features of theprosthesis1200 can be used in combination with any of the other prosthesis embodiments disclosed herein.
• 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, 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, the excess graft material can form 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, 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, 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, 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, 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, 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, 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, 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. 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, 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. 24A-25, 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. 24A and 24B, 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 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. 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, 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. 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, 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. 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. 25 is a top view of theprosthesis1200 ofFIG. 24. With reference toFIGS. 24-25, theprosthesis1200 can have fenestrations1202 formed in anenlarged portion1204aof thegraft1204. 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. 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. 25) such that thefenestrations1202 are separated by an angle (represented by angle Y inFIG. 25) that is less than 180 degrees.
• For example, thegraft1204 can have twofenestrations1202 formed at an angle away from the diametrically opposed position (represented by angle X inFIG. 25) of approximately 15 degrees such that thefenestrations1202 are separated by an angle (represented by angle Y inFIG. 25) that is approximately 150 degrees. 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. 25) that is between approximately 160 degrees and approximately 140 degrees.
• 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 this configuration, theenlarged portion1204aof thegraft1204 can be from approximately 20% to approximately 40% greater than thenon-enlarged portion1204b,1204cof thegraft1204.
• 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. 24-25, though not required, 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. 24A and 24B, although not required, 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. 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. Theprosthesis1200 can have a flared proximal end portion to increase the sealability of such end portion of theprosthesis1200.
• As described above, theprosthesis1200 can have one or more radiopaque markers, such as but not limited to the annular radiopaque marker1222 surrounding at least a portion of thefenestration1202, for improved visibility under fluoroscopy during deployment. Any of the radiopaque markers can be formed from gold or platinum, or any suitable material. Any of the radiopaque markers can be formed from a suitable non-reinforcing metallic material.
• FIG. 27 is a side view of thestent1206 shown inFIG. 24, 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. 28 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.26 and27-28, 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. The positioning of the plurality ofloops1240 and bends1242 can be longitudinally offset or staggered to decrease the collapsed diameter of theprosthesis1200.
• 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. 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, the connectingmembers1254 can have four struts. The connectingmembers1254 can have three or less struts, or can have five or more struts. The connectingmembers1254 can have a first connectingmember1254 having fewer struts than a second connectingmember1254.
• FIGS. 29-31 are oblique, side, and end views, respectively, of a fenestration alignment component2026 (also referred to as a push member or alignment device) that can be used in any of the delivery catheter embodiments disclosed herein.FIG. 32 is an oblique view of adelivery catheter2004 having thefenestration alignment component2026 ofFIG. 29.FIG. 33 is an exploded view of thedelivery catheter2004 shown inFIG. 32. In some delivery catheter embodiments, one or morefenestration alignment components2026 can be used in place of or in conjunction with one or morefenestration alignment components1026 described above in any of the delivery catheter embodiments disclosed herein.
• Therefore, thefenestration alignment component2026 can serve the same or similar function or be used for the same or similar procedural step or steps as with the embodiments of thefenestration alignment component1026 described above. Therefore, thefenestration alignment component2026 can be used in any of the procedures, steps, or methods as described above for thefenestration alignment component1026. For example, after the main body of a prosthesis (such as prosthesis1010) has been released from theouter sheath1006 and any other radial restraints, a user can independently or collectively axially advance thefenestration alignment component2026 relative to the guide sheath2024 (which can be the same as theguide sheath1024 described above) supporting thefenestration alignment component2026 such that a portion of thefenestration alignment component2026 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.
• Abody portion2027 of thefenestration alignment component2026 can be slidably positioned around or over an outside surface of theguide sheath2024. As illustrated inFIGS. 29,31, and32, thebody portion2027 can be cylindrical or tubular. Thebody portion2027 can have an inside diameter or size that is greater than an outside diameter or size of theguide sheath1024 so that thefenestration alignment component2026 can axially translate relative to theguide sheath1024. Thebody portion2027 can have in inner diameter or cross-sectional size of approximately 0.114 in, or from approximately 0.10 in or less to approximately 0.125 inches or more. Thebody portion2027 can have in outer diameter or cross-sectional size of approximately 0.126 in, or from approximately 0.110 in or less to approximately 0.15 inches or more.
• Thebody portion2027 can have a length of approximately 7.1 cm (2.80 in), or from approximately 5 cm (1.97 in) or less to approximately 10 cm (3.94 in), or between any values within the foregoing range. Thebody portion2027 can be formed from a PEBAX covered alloy coil. For example, thebody portion2027 can have a stainless steel coil with a PEBAX tube surrounding the coil. The PEBAX can have varying hardness. Thebody portion2027 can have a PTFE liner surrounding all or a portion of thebody portion2027. Additionally, thebody portion2027 can have a radiopaque marker or band supported thereon, or have portions or components thereof that are made from a radiopaque material. For example, a radiopaque band having a length of approximately 0.020 in to approximately 0.060 in can be supported by the body portion2037.
• As will be described in greater detail, thefenestration alignment component2026 can have a snare, tab, protrusion, or other similar feature supported by the body portion to engage a portion of the prosthesis adjacent to the fenestration. For example, with reference to the illustrated embodiments, thefenestration alignment component2026 can have a tab or protruding portion2028 (also referred to as a protrusion or projection) projecting from thebody portion2027. The protrudingportion2028 can project away from the outside surface of thebody portion2027 by approximately 0.036 in, or from approximately 0.025 in to approximately 0.050 in, or from approximately 0.030 in to approximately 0.045 in, or between any values within any of the foregoing ranges. The protrudingportion2028 can define a cross-sectional size (in at least one direction) or diameter that is from approximately 20% or less to approximately 40% or more greater than a cross-sectional size or diameter of thebody portion2027 and/or the fenestration, or between any values within this range.
• In some embodiments, the protruding portion or other component or element supported at an end of thebody portion2027 can be inflatable or otherwise moveable between a first position and a second position wherein, in the second position, such component or element projects away from thebody portion2027 more than in the first position. For example, without limitation, the component or element can be a small inflatable balloon positioned at an end of the body portion having a hollow wire in fluid communication with an inner volume thereof. Thepositioning wire2030 could be made hollow to allow for inflation of the inflatable component or element.
• The protrudingportion2028 can be integrally formed with thebody portion2027, or can be formed separately and adhered to, supported by, or otherwise coupled with thebody portion2027. The protrudingportion2028 can have a length of approximately 7 mm (0.276 in) or from approximately 5 mm (0.197 in) or less to approximately 10 mm (0.394 in) or more, or between any values within the foregoing range. The protrudingportion2028 can be made from PEBAX. The protrudingportion2028 can be made from a PEBAX material having a higher hardness value than the PEBAX material used to form thebody portion2027.
• As mentioned, thefenestration alignment component2026 can be configured to engage a fenestration of a prosthesis deployable by thedelivery catheter2004. For example, the enlarged or protrudingportion2028 can have a size or profile that is greater than a size or profile of theguide sheath2024 or of thebody portion2027 of thefenestration alignment component2026 so that, while theguide sheath2024 can be advanced through the fenestration, the protrudingportion2028 can be sized and configured to be larger than the size or diameter of the fenestration so that the protrudingportion2028 does not pass through the fenestration.
• Theenlarged portion2028 of thefenestration alignment component2026 can have a circular cross-sectional shape or, as illustrated inFIGS. 29-31A, a non-circular cross-sectional shape. For example, theenlarged portion2028 can have an approximately triangular or pointed shape with a rounded upper surface orportion2028a. Theenlarged portion2028 can have a circular cross-sectional shape or a pointed shape with more than one pointed or protruding portion, or any other suitable shape.
• With reference toFIGS. 29-30, theenlarged portion2028 can have a taperedsurface2028bat the trailing end of theenlarged portion2028. The taperedsurface2028bcan facilitate the removability of thefenestration alignment component2026 if theenlarged portion2028 of thefenestration alignment component2026 is inadvertently advanced through a fenestration.
• Thefenestration alignment components2026 can each be attached topositioning wires2030 such that axially advancing or retracting thepositioning wires2030 will advance or retract thefenestration alignment components2026. Thepositioning wires2030 can each define a tapering cross-sectional size that decreases toward a distal end of thepositioning wire2030 such that a cross-sectional size of thepositioning wire2030 near thebody portion2027 is smaller than a cross-sectional size of thepositioning wire2030 near the catheter handle. Thepositioning wire2030 can made from a PTFE coated stainless steel, such as 304, or from any other suitable material or combination of materials. Thepositioning wire2030 can have a diameter or cross-sectional size as large as approximately 0.0345 in, tapering down to a diameter or cross-sectional size of approximately 0.0200 in. Thepositioning wire2030 can have a uniform diameter or cross-sectional size along the length thereof.
• With reference toFIG. 31B, anend portion2030aof thepositioning wire2030 can overlap and be affixed to the body portion2037 of thefenestration alignment component2026. For example, between approximately 1.0 cm (0.394 in) or less and 1.5 cm (0.591 in) or more of thepositioning wire2030 can overlap the body portion2037. Theend portion2030acan be bonded to the body portion2037 using any suitable technique or process. For example, theend portion2030acan be thermally bonded to the body portion2037 using one or more PET sleeves. A portion of theend portion2030acan be coined or flattened. The end portion can have a greater surface area than a remainder of theend portion2030a. For example, approximately half of theend portion2030acan be coined or flattened.
• FIG. 32 is an oblique view of adelivery catheter2004 having thefenestration alignment component2026 ofFIG. 29.FIG. 33 is an exploded view of thedelivery catheter2004 shown inFIG. 32.FIG. 32 illustrates ahandle portion2050 of thedelivery catheter2004, which can provide an entry point for theguide sheaths2024 and thepositioning wires2030 so as to provide an orifice or access port for these components into the main body of thedelivery catheter2004. In this configuration, a surgeon or user can manipulate theguide sheaths2024 andfenestration alignment components2026 by manipulating the end portions of theguide sheaths2024 andpositioning wires2030 that extend proximally from the end of thehandle portion2050 of the delivery catheter.
• Thecatheter2004 can have two ormore guide sheaths2024 and two or morefenestration alignment components2026, or the same number ofguide sheaths2024 andfenestration alignment components2026 as the number of fenestrations in the prosthesis. Thecatheter2004 havingguide sheaths2024 withfenestration alignment components2026 as described herein can be configured such that theguide sheaths2024,fenestration alignment components2026, and/orpositioning wires2030 are advanceable within standard lumen formed in thedelivery catheter2004. The lumen of thedelivery catheter2004 may be enlarged or sized and configured to accommodatesuch guide sheaths2024 withfenestration alignment components2026.
• FIG. 34 is a sectional view of a portion of a patient's vasculature, showing thefenestration alignment component2026 illustrated inFIG. 29 advancing an inner wall of the prosthesis adjacent to a fenestration toward an ostium of the target branch vessel. As illustrated, thefenestration alignment component2026 of thecatheter2004 can be axially advanced relative to the guide sheath2024 (which can be the same as any other guide sheath embodiments disclosed herein, including without limitation guide sheath1024) by advancing thepositioning wire2030 distally to push thefenestration1011 of theprosthesis1010 over thebranch sheath2024 and into approximate alignment with the ostium of the branch vessel. Thecatheter system2004 can be configured to not have afenestration alignment component2026, and can accordingly be configured to deploy a fenestrated graft without the use of such a component. As will be described below, snares, protrusions, tabs, or other features can be formed on thesheaths1024 to push the fenestrations toward the branch vessel ostium.
• FIG. 35 is a sectional view of a portion of a patient's vasculature, showing a branch stent being advanced into the target branch vessel while thefenestration alignment component2026 can be used to maintain the inner wall of the prosthesis adjacent to a fenestration in the prosthesis in the desired position relative to the ostium of the target branch vessel. As illustrated inFIG. 35, thefenestration alignment components2026 have been advanced to a second position, the second position being defined as the position where thefenestrations1011 are approximately aligned with the ostium of the target branch vessels. As illustrated inFIG. 35, a covered or uncoveredbranch stent1084 can be deployed in the branch vessel by advancing thebranch stent1084 through thebranch sheath2024 using a suitable catheter, such as a renal stent catheter, into the target vessel, after the angiographic catheter has been removed from thebranch sheath2024.
• 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 sheath2024 has been at least partially retracted so as to not interfere with the expansion of thebranch stent1084. Thefenestration alignment components2026 may need to be at least partially withdrawn before deploying thestents1084, to enable the inflation balloon to expand thestents1084. Theinflation balloon1086 can be configured to expand and flare a portion of thestent1084 within or to the inside of thefenestration1011 formed in the prosthesis. Thereafter, the components comprising thedelivery catheter2004 can be withdrawn, and/or additional prostheses can be deployed in the patient's vasculature, including without limitation a suprarenal stent graft, or other desired components.
• As mentioned, any embodiments of thedelivery catheter2004 can have any of the same features, materials, components, dimensions, or other details of any other catheter disclosed herein, including without limitation the embodiment(s) of thedelivery catheter1004 described above. Like numbered features shown in the illustrations of thedelivery catheter2004 can be the same or similar to the same numbered features of thedelivery catheter1004 embodiments described 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 sub combinations 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. Unless otherwise defined herein, the term approximate or approximately means values within 10% of the stated value.
• Additionally, any embodiments of the fenestration alignment components or devices disclosed herein can be used to deploy any suitable fenestrated prosthesis, with or without modification within the scope of one of ordinary skill in the art. For example and any embodiments of the fenestration alignment components or devices disclosed by the references previously incorporated by reference in their entireties as if fully set forth herein. All such embodiments and combinations of embodiments are hereby incorporated by reference as if fully set forth herein. Further, any embodiments of the fenestration alignment components or devices disclosed herein can be used in combination with any of the delivery devices disclosed in either of the foregoing applications, and such combinations are hereby incorporated by reference as if fully set forth herein.

Claims (20)

1. A fenestrated graft deployment system, comprising:

a delivery catheter comprising a catheter body;

an endoluminal prosthesis having a main graft body, the main graft body having lumen therethrough and a first opening laterally through a wall of the main graft body;

a first guidewire prepositioned within the delivery catheter extending through at least a portion of the catheter body into a main lumen of the endoluminal prosthesis and through the first opening in the wall of the prosthesis when the delivery catheter is in a predeployment state; and

a first fenestration alignment device extending through at least a portion of the delivery catheter configured to be axially moveable relative to the first guidewire between a first position and a second position;

wherein:

the first fenestration alignment device is independently moveable relative to the first guidewire between at least the first and the second positions; and

at least a portion of the first fenestration alignment device is larger than the first opening in at least one direction such that a portion of the fenestration alignment device engages the main graft body adjacent to the first opening when the first fenestration alignment device is advanced toward the second position.

2. The fenestrated graft system ofclaim 1, wherein the first fenestration alignment device is configured to approximately align the first opening with an ostium of a first target branch vessel when the first fenestration alignment device is advanced to the second position.

3. The fenestrated graft system ofclaim 1, wherein at least a portion of the fenestration alignment device is configured to slide over an outside surface of the first guidewire.

4. The fenestrated graft system ofclaim 1, wherein a distal end portion of the first fenestration alignment device has a wall portion that surrounds at least a portion of the guidewire.

5. The fenestrated graft system ofclaim 1, wherein the first guidewire prepositioned through the opening is a hollow guidewire or hollow sheath.

6. The fenestrated graft system ofclaim 1, wherein a distal end portion of the first fenestration alignment device comprises a coiled component that is flexible enough to bend when being advanced over the first guidewire.

7. The fenestrated graft system ofclaim 1, wherein the first fenestration alignment device comprises a tubular shaped member and a protrusion projecting from an outside surface of a distal portion of the tubular shaped member, the protrusion being sized and configured to engage the main graft body adjacent to the first opening when the first fenestration alignment device is advanced toward the second position.

8. The fenestrated graft system ofclaim 1, further comprising a first branch stent configured to be deployed at least partially within the first opening after the first opening has been approximately aligned with the ostium of the first target vessel.

9. The fenestrated graft system ofclaim 1, comprising a second guidewire and a second fenestration alignment device.

10. A fenestration push device for use in a fenestrated prostheses deployment catheter, comprising:

a body portion defining a lumen therethrough, the lumen having a first diameter or cross-sectional size; and

a protrusion supported at or adjacent to a distal end of the body portion, the protrusion projecting away from an outside surface of the body portion and defining a second cross-sectional size;

wherein:

the second cross-sectional size of the fenestration push device at the location of the protrusion is greater than the first diameter or size of the body portion; and

the second cross-sectional size of the protrusion is greater than a cross-sectional size of a fenestration formed in a fenestrated graft that the fenestration push device will be used with.

11. A delivery catheter comprising the fenestration push device ofclaim 10 and a fenestrated prosthesis.

12. The delivery catheter ofclaim 11, further comprising a guide sheath prepositioned in the delivery catheter such that, when the delivery catheter and the fenestrated prosthesis are in a pre-deployment state, the guide sheath is positioned through a lumen of the fenestrated prosthesis and advanced through a fenestration in the fenestrated prosthesis.

13. The delivery catheter ofclaim 12, wherein the body portion is configured to axially translate over the outside surface of the guide sheath.

14. The delivery catheter ofclaim 11, wherein at least a proximal portion of the fenestration push device extends proximally from a handle portion of the delivery catheter toward a user of the device so that the user can advance the fenestration push device toward a fenestration in the fenestrated prosthesis by distally advancing the proximal portion of the fenestration push device.

15. The delivery catheter ofclaim 14, wherein the proximal portion of the fenestration push device comprises a wire.

16. A method of deploying a fenestrated endoluminal prosthesis in a patient's vasculature, comprising:

advancing a catheter supporting a fenestrated endoluminal prosthesis through a patient's vasculature to a target vessel location, wherein the prosthesis has a main graft body comprising a first opening through a wall thereof;

advancing a first guide sheath through the first opening and into a first branch vessel; and

advancing a first fenestration alignment device into contact with the prosthesis adjacent to the first opening through the wall of the prosthesis so as to approximately align the first opening with an ostium of the first branch vessel.

17. The method of deploying an endoluminal prosthesis ofclaim 16, further comprising deploying a first branch stent at least partially within the first opening through the wall of the endoluminal prosthesis.

18. The method of deploying an endoluminal prosthesis ofclaim 16, wherein advancing the first fenestration alignment device into contact with the prosthesis adjacent to the first opening through the wall of the prosthesis so as to approximately align the first opening with an ostium of the first branch vessel comprises advancing the first fenestration alignment device along the first guide sheath.

19. The method of deploying an endoluminal prosthesis ofclaim 16, wherein:

the first fenestration alignment device comprises a tubular body portion configured to surround the first guide sheath; and

advancing the first fenestration alignment device into contact with the prosthesis adjacent to the first opening through the wall of the prosthesis so as to approximately align the first opening with an ostium of the first branch vessel comprises advancing the first fenestration alignment device over an outside surface of the first guide sheath.

20. The method of deploying an endoluminal prosthesis ofclaim 16, wherein the first guide sheath is pre-positioned through the first opening through the wall of the prosthesis when the prosthesis is in a pre-deployment state.

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